[Senate Hearing 106-1005]
[From the U.S. Government Publishing Office]
S. Hrg. 106-1005
PAIN RELIEF PROMOTION ACT
=======================================================================
HEARING
before the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
on
H.R. 2260
__________
APRIL 25, 2000
__________
Serial No. J-106-77
__________
Printed for the use of the Committee on the Judiciary
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COMMITTEE ON THE JUDICIARY
ORRIN G. HATCH, Utah, Chairman
STROM THURMOND, South Carolina PATRICK J. LEAHY, Vermont
CHARLES E. GRASSLEY, Iowa EDWARD M. KENNEDY, Massachusetts
ARLEN SPECTER, Pennsylvania JOSEPH R. BIDEN, Jr., Delaware
JON KYL, Arizona HERBERT KOHL, Wisconsin
MIKE DeWINE, Ohio DIANNE FEINSTEIN, California
JOHN ASHCROFT, Missouri RUSSELL D. FEINGOLD, Wisconsin
SPENCER ABRAHAM, Michigan ROBERT G. TORRICELLI, New Jersey
JEFF SESSIONS, Alabama CHARLES E. SCHUMER, New York
BOB SMITH, New Hampshire
Manus Cooney, Chief Counsel and Staff Director
Bruce A. Cohen, Minority Chief Counsel
C O N T E N T S
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STATEMENT OF COMMITTEE MEMBER
Page
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah...... 1
WITNESSES
Bleich, Rabbi J. David, on behalf of the Union of Orthodox Jewish
Congregations of America....................................... 59
Caplan, Arthur L., Director, Center for Bioethics, and Trustee
Professor, University of Pennsylvania.......................... 57
Chevlen, Eric, M.D., Director of Palliative Care, Cancer Care
Center, St. Elizabeth Hospital................................. 42
Foley, Kathleen, M.D., Attending Neurologist, Memorial Sloan-
Kettering Cancer Center........................................ 63
Hunter, Walter R. M.D., Associate National Medical Director,
Vista Care Hospice............................................. 69
Nickles, Hon. Don, a U.S. Senator from the State of Oklahoma..... 4
Smith, Hon. Gordon, a U.S. Senator from the State of Oregon...... 37
Wyden, Hon. Ron, a U.S. Senator from the State of Oregon......... 21
APPENDIX
Proposed Legislation
Bill H.R. 2260................................................... 83
Additional Submissions for the Record
American Nurses Association, prepared statement.................. 97
Campbell, James N. M.D., Johns Hopkins Medicine, Department of
Neurosurgery, letter........................................... 95
Fins, Joseph J., M.D., F.A.C.P., Associate Professor of Medicine,
Weill Medical College of Cornell and Director of Medical
Ethics, New York Presbyterian hospital, prepared statement..... 101
Fishman, Scott M., M.D., Chief, Division of Pain Median and
Associate Professor of Anesthesiology, University of
California, Davis School of Medicine, prepared statement....... 104
Gilbert, John A. Jr., Hyman, Phelps & McNamara, PC, letter....... 91
Guest, James A., Executive Director, American Pain Foundation,
prepared statement............................................. 98
Joranson, David E., Senior Scientist, Director of the Pain &
Policy Studies Group, University of Wisconsin Comprehensive
Cancer Center, prepared statement.............................. 105
Miech, Ralph P., M.D., Ph.D., Brown University School of
Medicine, Dept. of Molecular Pharmacology, Physiology &
Biotechnology, letter.......................................... 96
National Association of Pro-Life Nurses, prepared statement...... 107
National Conference of Catholic Bishops, prepared statement...... 109
National Right to Life Committee, prepared statement............. 118
Oncology Nursing Society, prepared statement..................... 118
Pain Care Coalition, prepared statement.......................... 119
Physicians for Compassionate Care, prepared statement............ 121
Rose, Harvey L., M.D., Board Certified Family Practitioner,
prepared statement............................................. 126
Sparks, Robert M., letter........................................ 97
The Pain Relief Promotion Act.................................... 3
Vorenberg, James, Harvard Law School, letter..................... 94
PAIN RELIEF PROMOTION ACT
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TUESDAY, APRIL 25, 2000
U.S. Senate,
Committee on the Judiciary,
Washington, DC.
The committee met, pursuant to notice, at 9:39 a.m., in
room SD-226, Dirksen Senate Office Building, Hon. Orrin G.
Hatch (chairman of the committee) presiding.
Also present: Senators Sessions and Grassley.
OPENING STATEMENT OF HON. ORRIN G. HATCH, A U.S. SENATOR FROM
THE STATE OF UTAH
The Chairman. Today, the Judiciary Committee is holding a
hearing on H.R. 2260, the Pain Relief Promotion Act. The Senate
companion, S. 1272, was introduced by Senator Nickles of
Oklahoma. We are happy to have Senator Nickles, Senator Wyden,
and Senator Smith here, as well.
Similar legislation has been considered by this committee
in the past. During the 105th Congress, the Senate Judiciary
Committee held a hearing on S. 2151 and reported it to the
Senate on September 24, 1998. In this Congress, the Pain Relief
Promotion Act was passed by the House of Representatives on
October 27, 1999, by a substantial 271 to 156 vote. In
addition, the Senate HELP Committee held a hearing on this
legislation late last year.
The Pain Relief Promotion Act has two main purposes. First,
it encourages practitioners to prescribe and administer
controlled substances to relieve pain and discomfort.
Practitioners should be encouraged to treat pain aggressively
even when the treatment may increase the risk of death. Almost
every member of the committee has known someone who has
confronted unbearable pain in the end-of-life situation, and we
all understand that the medical community must be able to
exercise certain discretion in ministering to those patients in
these situations.
Title I of the bill instructs HHS through the Agency for
Healthcare Research and Quality to undertake activities that
will promote and advance scientific understanding of pain
management and palliative care. This legislation states that
alleviating pain with controlled substances in the usual course
of medical practice is a legitimate medical purpose. Because
pain treatment and palliative care are protected by a safe
harbor is one reason why there is substantial support for this
legislation from health care providers.
The second purpose of this legislation is to prevent the
dispensing of controlled substances for causing death or
assisting someone in causing his or her death. This includes
the practice of physician assisted suicide. I believe that this
practice is abhorrent. The question of how people should
conduct their lives when confronted by a terminal disease
involves intensely personal moral and religious issues. The old
and wise principle of, ``first, do no harm,'' is irreconcilable
with assisted suicide. I think the majority of the members of
this committee agree with me.
In other words, aggressive pain management should be
encouraged and assisted suicide using federally controlled
substances should not be permitted under any circumstances. I
do not think reasonable people have any difficulty discerning
the difference.
Let us not forget why we are here. This bill simply tries
to correct an erroneous, soft-headed interpretation of title 21
of the Controlled Substances Act. Attorney General Reno, with
her eye on the Oregon law, reinterpreted an existing Federal
statute in a fashion contrary to DEA Administrator Constantine,
our nation's chief drug enforcement officer. Administrator
Constantine had taken the traditional and legitimate view that
the CSA does not permit controlled substances to be used to
bring about assisted suicide or euthanasia. Unfortunately, the
Attorney General chose to interpret the statute so that Oregon
would be granted an exemption and, thus, Oregon's physicians
would be allowed to use controlled substances while assisting
in a suicide.
The irony of this decision is that even the President has
signaled his opposition to the practice of assisted suicide.
Through this legislation, the statute will be applied
consistently to all 50 States. No exemptions will be granted
just because a State like Oregon has approved an assisted
suicide referendum.
But let me make it clear that this bill does not direct the
DEA to launch a major investigatory initiative into the pain
management arena. In fact, to address the concerns of health
care providers, the substitute bill that I will offer during
the committee's markup of H.R. 2260 contains a provision that
is neither in the House bill nor the Senate companion bill.
The new provision, modeled on the legislation reported out
of this committee during the 105th Congress, establishes the
higher clear and convincing evidentiary standard for DEA
administrative hearings involving allegations of assisted
suicide or euthanasia. I know DOJ and DEA oppose this higher
standard. However, when we completed our markup in 1998, I
pledged to the members of this Congress, to Senators Leahy and
Feinstein, that I would continue to work to see whether we
could develop a broader consensus on this bill. I believe it is
proper for Congress to make a strong statement about the need
for state-of-the-art pain management and palliative care and to
restore the original intent of our drug laws relative to
assisted suicide.
Several groups who adamantly opposed a bill from the 105th
Congress now support it. These groups include the National
Hospice Organization, the Hospice Association of America, the
American Academy of Pain Management, the American Society of
Anesthesiologists, the Pain Care Coalition, and the American
Medical Association. Without objection, I would like to include
in the record a list of over 40 organizations and 20 prominent
individuals.
[The information of the Chairman follows:]
The Pain Relief Promotion Act
h.r. 2260 and the substitute amendment
Supporting Organizations
Aging With Dignity
Agudath Israel of America
American Academy of Pain Management
American College of Osteopathic Family Physicians
American Medical Association
American Society of Anesthesiologists
Americans for Integrity in Palliative Care
Americans United for Life
Association of Pain Management Anesthesiologists
California Disability Alliance
Catholic Health Association
Catholic Hospice (Florida)
Catholic Medical Association
Christian Medical & Dental Society
Coalition of Concerned Medical Professionals
Eagle Forum
Family Research Council
Florida Hospices and Palliative Care, Inc.
Florida Medical Association
Focus on the Family Physicians Resource Council
Friends of Seasonal and Service Workers (Oregon)
Hope Hospice and Palliative Care (Florida)
Hospice Association of America
Iowa Medical Society
Louisiana State Medical Society
Lutheran Church-Missouri Synod
Medical Association of the State of Alabama
Medical Society of Delaware
Medical Society of New Jersey
Medical Society of the State of New York
Michigan State Medical Society
National Conference of Catholic Bishops
National Hospice Organization
National Legal Center for the Medically Dependent and Disabled
National Right to Life
Nebraska Coalition for Compassionate Care
Not Dead Yet
Oklahoma State Medical Association
Pain Care Coalition
American Academy of Pain Medicine
American Headache Society
American Pain Society
Pennsylvania Medical Society
Physicians for Compassionate Care
Supportive Care of the Dying: A Coalition for Compassionate Care
South Carolina Medical Association
Union of Orthodox Jewish Congregations of America
Virginia Association For Hospices
Vitas Healthcare Corporation (CA, FL, IL, OH, PA, TX, WI)
Wisconsin Council on Developmental Disabilities
Individual Endorsements
Lynne B. Bissonnette, M.D., Ph.D., Psychiatrist, Portland, Oregon
James K. Boehnlein, M.D., M.Sc., Assoc Professor of Psychiatry, Oregon
Health Sciences University
Ira Byock, M.D., The Palliative Care Service
Eric Chevlen, M.D., Director of Palliative Care, Cancer Care Center,
St. Elizabeth's Medical Center, Youngstown, Ohio
Carlos F. Gomez, M.D., Ph.D., Director, Palliative Care Service,
University of Virginia, School of Medicine
Dorothy W. Hagan, Ph.D. RD, LD, Director, Oregon Health Sciences
University
David Harris, M.D, OB-GYN, White Wilson Medical Center, Pennsylvania
Catherine Hamilton, M.A., Counselor, Beaverton, Oregon
N. Gregory Hamilton, M.D., Portland, Oregon
Herbert Hendin, M.D., Dir. of American Foundation for Suicide
Prevention
Dr. Walter Hunter, M.D., Vista Hospice
C. Everett Koop, M.D., former U.S. Surgeon General
Ralph P. Miech, M.D., Ph.D., Brown University School of Medicine
Robert D. Orr, M.D., Director of Ethics, Loma Linda University Medical
Center, & Chairman of California Medical Association's Council on
Ethical Affairs
Edmund D. Pellegrino, M.D., Georgetown University Medical Center
Daniel L. Phillips, M.D., Eugene, Oregon
Thomas M. Pitre, M.D., Northwest Urological Clinic, Portland, Oregon
James P. Rathmell, M.D., Burlington, Vermont
William E. Ryan, M.D., FACP, Pennington, New Jersey
Robert J. Saxer, M.D., Fort Walton Beach, Florida
Daniel Sulmasy, O.F.M, M.D., Ph.D. Professor of Medicine and Director
of Bioethics Institute, New York Medical College
William L. Toffler, M.D., Portland, Oregon
The Chairman. Finally, I want to thank all of our witnesses
who have taken time out of their busy schedules to be with us
today. I certainly appreciate all of your willingness to share
your views with us on this important issue.
We are particularly happy to have three Senators here today
who have interest in this bill, who have major interest in this
bill. We are happy to welcome Senator Nickles, the majority
whip in the U.S. Senate, Senator Wyden from Oregon, and Senator
Smith from Oregon, both from the State that has handled a
number of these problems.
We will turn to you, Senator Nickles, first, and then we
will go to Senator Wyden and then Senator Smith.
STATEMENT OF HON. DON NICKLES, A U.S. SENATOR FROM THE STATE OF
OKLAHOMA
Senator Nickles. Mr. Chairman, thank you very much. I very
much appreciate your opening statement. I appreciate the work
that you have done on this issue. We have had hearings before
your committee in the past. I also want to compliment you on
your perfecting amendment to legislation that Senator Lieberman
and myself have been working on now for 3 years. We have 42
cosponsors on this legislation, bipartisan support. My thanks
to my colleague, Senator Lieberman, as well, for his
leadership. As you mentioned, the House has previously passed
this legislation by almost a 2-to-1 margin in the House.
Mr. Chairman, at this point, I will ask unanimous consent
that my statement be inserted in the record.
The Chairman. Without objection.
Senator Nickles. In addition, I would ask that a series of
other things that I would like be included in the record: A
statement that I made on November 18 in the Congressional
Record on the effects of this bill; a DEA letter regarding the
substitute amendment, which you may have included in your
statement, I am not sure; a legal analysis on this bill; a
letter from the American Medical Association in support of the
bill; a Pain Care Coalition statement of support for the bill;
and a couple of news articles, an editorial from the Oregonian,
``A State's Rights and a State's Wrongs,'' it was October 19,
1999, and also a Wall Street Journal editorial, ``Don't Kill
the Pain Relief Bill,'' November 4, 1999.
[The information of Senator Nickles is attached to his
prepared statement.]
Senator Nickles. Mr. Chairman, we have been working on this
bill for a long time and we need to pass it. A very similar
measure passed this committee, I believe, by a vote of 11 to
six in the last month or two of the session in 1998. We did not
have time to get it worked through at that point.
But it also gave us more time to alleviate some of the
concerns that some groups and organizations raised. You
mentioned at that point, I believe the Hospice Association was
opposed to the legislation. We have alleviated those concerns.
They are now endorsing the legislation. The American Medical
Association endorses this legislation. And it has been
improved, and my compliments to you and your staff in working
with our staff and others, I think making improvements to
alleviate any concerns about this legislation from the negative
standpoint.
This legislation is about two things. It is about
alleviating pain. These are federally controlled substances.
They are very strong. They can be deadly. They can alleviate
pain, and we say by all means they should be used to alleviate
pain, and these are controlled by the Federal Government. They
have been controlled by the Federal Government since 1914. The
Harrison Narcotics Act in 1914 controlled these very strong
substances, further changed by the Controlled Substance Act in
1970. So they have been controlled.
That Act has been in existence for 30 years and it says
that these very strong substances can be used for legitimate
medical purposes. We state very clearly in the legislation and
by your amendment, by the legislation that we have been working
on, that alleviating pain is a legitimate medical purpose.
Assisted suicide is not, never has been, should not be, and we
will further clarify it that it is not. Assisted suicide is not
a legitimate medical purpose.
That is really what the bill does. Let us make it possible
to use these very strong drugs. Let us even encourage the use
of these very strong drugs to alleviate pain. Let us make sure
that these very strong drugs are not abused to kill someone.
That is important. It should not be necessary.
Attorney General Reno made a mistake in the letter. She
cannot change a statute by a letter. The statute is very clear.
Let me just read one paragraph. You mentioned Mr. Constantine,
who is head of the Drug Enforcement Agency. This is in his
November 5, 1997, letter. He said, ``My staff has carefully
reviewed the number of cases, briefs, law review articles, and
State laws regarding physician assisted suicide, including the
documents referenced in your letter. In addition, my staff has
conducted a thorough review of prior administrative cases in
which physicians have dispensed controlled substances for other
than legitimate medical purpose. Based on that review, we are
persuaded that delivering, dispensing, or prescribing
controlled substance with the intent of assisting suicide would
not be under any current definition a legitimate medical
purpose.''
They did a lot of work. This was not a quick study. And he
said, these drugs should be used to alleviate pain. They should
not be used for assisted suicide. That is exactly right.
Now, one question, I notice my two friends and colleagues
from Oregon are here and I am continually reading, well, this
is a bill to overturn Oregon's law. I have a couple of
comments. This bill does not overturn Oregon's law, but let me
be perfectly clear. Oregon does not have the right to pass a
referendum or a statute that overturns Federal law. These are
federally controlled substances. They have been controlled by
the Federal Government since 1914. The Controlled Substance Act
passed in 1970 and the Federal law says these can only be used
for legitimate medical purposes, period, and that has never
included assisted suicide.
So in reference to States' rights, and I think I am
probably as big an advocate for States' rights as anybody in
the Senate, I believe very strongly in States' rights. I have
served in the State legislature. But a State does not have the
right to overturn Federal law. The State of Oregon or the State
of Oklahoma cannot pass a statute that says, we want to
legalize cocaine or legalize heroin for any purpose. They
cannot do it. They cannot do it.
You cannot do it and say, well, we are going to use these
drugs for assisted suicide because we think it is fine. Oregon
or any other State can have all the referendums they want on
assisted suicide but they cannot change Federal statute,
Federal law, the law of the land, law that has been in
existence for 85 years and say, oh, well, these are okay. We
are going to change Federal law for assisted suicide. You
cannot do it.
So we try to clarify that. We clarify this bill very, very
clearly. Use these very strong drugs to alleviate pain. We even
put in a safe harbor for physicians. If the use of these drugs
accelerates the fact that somebody might die earlier, as long
as the purpose is to use it to alleviate pain, no problem. If
the intent and purpose is to end someone's life, to participate
in assisted suicide, and in your amendment, even strengthening
the standard test. I am not going to complain about that, but
the main intent should not be assisted suicide. If that is the
case, it is not a legitimate medical purpose and therefore it
should not be allowed.
With that, Mr. Chairman, I will just thank you for your
work and your effort and I look forward to not only getting
this through the committee but getting it through the Senate,
as well.
The Chairman. Thank you, Senator Nickles.
[The prepared statement of Senator Nickles follows:]
Prepared Statement of Senator Don Nickles
Mr. Chairman, Senator Leahy and members of the Senate Judiciary
Committee, I thank you for holding this hearing today and allowing me
to come before you to speak on H.R. 2260, The Pain Relief Promotion
Act, and the important implications it has for the treatment of pain
and other end of life symptoms including clarifying the use of
federally controlled substances by caregivers throughout the country.
Senator Lieberman and I have offered identical legislation to address
these issues, S. 1272 the Pain Relief Promotion Act. It is my
understanding that today we will also be discussing the substitute
amendment to H.R. 2260 which Chairman Hatch is offering to this
legislation. This substitute amendment goes even further to ensure that
the needs of patients who are suffering in pain and other distressing
symptoms will be adequately treated. It does so without undermining the
intent of the original legislation and I believe improves the original
legislation to even more clearly address the role of the federal
government regarding federally controlled substances.
It has been nearly three years since Senator Lieberman and I first
offered legislation to make clear Congress' intent when it comes to
employing federally controlled substances especially in end-of-life
situations, That bill, the Lethal Drug Abuse Prevention Act, had 23
bipartisan cosponsors. A hearing was held on the bill in the Senate
Judiciary Committee and it was passed out of the Committee by a vote of
11-6, on September 24, 1998. Identical legislation was also offered in
the House by Chairman Hyde which, following a hearing, passed out of
the House Judiciary Committee. However, due to the few legislative days
left in the session it was not brought to either the House or Senate
floor.
Immediately following the close of session in 1998 we began work on
new legislation to respond to the concerns of the medical community on
the impact of the Lethal Drug Abuse Prevention Act. We started from
scratch in re-drafting legislation with three goals: (1) Make clear
under the Controlled Substances Act (CSA) the federal standard that no
one can use federally controlled substances for assisted suicide, and
do so without creating new regulatory authority; (2) promote a greater
understanding of pain management and palliative care both in the
medical community and the law enforcement community; (3) gain the
support of the National Hospice Organization, and American Medical
Association, who previously opposed the bill.
On June 23, 1999, Senator Lieberman and I introduced legislation
that accomplished those three goals, S. 1272, the Pain Relief Promotion
Act. First, it clarifies federal law on the use of controlled
substances. The bill:
Provides an additional ``safe-harbor'' for physicians by
establishing, for the first time in federal law, that under the
Controlled Substances Act the relief of pain and discomfort is a
``legitimate medical purpose'', even if the large doses used in
treating pain may increase the risk of death (sometimes called the
principle double effect). However, the intentional use of these
drugs to cause death or assist in causing death is not allowed.
Restore the current federal policy against assisted suicide in
49 states to all 50 states.
Provide for the education of federal, state, and local law
enforcement personnel in how to better accommodate the appropriate
and necessary use of controlled substances for pain and discomfort.
Second, the bill provides federal support for training and
research. It:
Establishes in the Agency for Healthcare Research and Quality
(AHRQ) [pronounced ``ark''], a program of ``Palliative Care
Research and Quality'' to develop and advance scientific
understanding of pain management and palliative care and make
available that information.
Provides in Health Research Services Act (HRSA) [pronounced
``her-sa''], $5 million per year for grants and contracts to
medical schools, hospices and other sites to train physicians and
other health practitioners in the treatment of pain and associated
symptoms, especially at the end of life.
Third, it is supported by over 40 organizations including:
American Medical Association, National Hospice Association,
Hospice Association of America, American Academy of Pain
Management, American Society of Anesthesiologists, American College
of Osteopathic Family Physicians, Americans for Integrity in
Palliative Care, Catholic Health Association, Physicians for
Compassionate Care, Vitas Healthcare Corporation, National Right to
Life, Christian Medical & Dental Society, Eagle Forum, Hope Hospice
and Palliative Care (Florida), National Conference of Catholic
Bishops, Union of Orthodox Jewish Congregations of America, Not
Dead Yet, Oklahoma State Medical Association, and Aging With
Dignity.
The House and Senate both have taken action on the Pain Relief
Promotion Act. In the House, hearings were held in the House Judiciary
Committee, the bill was passed out of both the House Judiciary
Committee and House Commerce Committee, and on October 27, 1999, the
bill was passed in the House by a vote of 271-156. In the Senate a
hearing was held in the Health, Education, Labor and Pensions Committee
on October 13, 1999. Following passage of H.R. 2260 in the House, the
bill was referred to the Senate Judiciary Committee. Today we are again
meeting to hear testimony on this bill and the substitute amendment to
be considered. It is my hope that this will be the final hearing on
this issue and the bill will be passed out of the Judiciary Committee
and sent to the Senate floor where it will be debated, passed, and
signed into law.
It is essential that Congress does not remain silent. Congress has
acted with one voice previously to ensure that no federal program,
facility or employee is involved in assisted suicide. Enactment of the
Pain Relief Promotion Act will ensure that federal authorization to
prescribe DEA-regulated drugs does not include the authority to
prescribe such drugs to specifically cause a patient's death.
Since 1914, the federal government has had jurisdiction over
dangerous drugs. In 1970 Congress passed the Controlled Substances Act
(CSA) which gave responsibility for such substances to the Drug
Enforcement Administration (DEA) and charged them with the
responsibility of overseeing these narcotics and dangerous drugs. The
CSA states that these federally controlled drugs can only be prescribed
for a ``legitimate medical purpose'' and only by a physician who has a
DEA registration. It is important to understand that while a physician
receives his license to practice from state medical boards, he receives
a separate DEA registration to prescribe federally controlled
substances from the federal government. In 1984 Congress strengthened
the CSA out of concern over the use of prescription drugs in lethal
overdoses. Nowhere in the history of the Controlled Substances Act has
death ever been considered a ``legitimate medical purpose.'' However,
on June 5, 1998, Attorney General Janet Reno issued a decision which
overturned the previous DEA ruling that assisted suicide, intentionally
causing a patient's death, was not a legitimate medical purpose and
therefore federally controlled substances could not be used for that
purpose. The Attorney General concluded the Controlled Substances Act
does not authorize adverse action against a physician who prescribes a
controlled substance to assist in a suicide in compliance with the
Oregon law. She stated that Congress did not ``intend to override a
state determination as to what constitutes legitimate medical practice
in the absence of a federal law prohibiting that practice.''
The Attorney General failed to point out that federal law is
clearly intended to prevent the use of these drugs for lethal
overdoses, and contains no exception for deliberate overdoses approved
by a physician. Nor does that law contain any exception for giving
dangerous drugs to terminally ill patients--on the contrary, the
federal government has successfully argued before the Supreme Court
against allowing any such loophole in its drug laws. Every federal
agency, health program, health care facility and health professional is
forbidden to treat assisted suicide as though it were part of
legitimate medical practice. Also, President Clinton maintains his
longstanding position against assisted suicide and any federal support
for that procedure.
In spite of the Attorney General's determination the fact is that
federally controlled substances are exactly that . . . . federally
controlled. Under present federal law, the Controlled Substances Act,
these federally controlled substances can only be prescribed for a
``legitimate medical purpose'' in the usual course of professional
practice, to promote public health and safety. A lethal overdose,
otherwise known as assisted suicide, has never been considered a
legitimate medical purpose and certainly does not promote public health
and safety.
When Oregon passed a state law to allow physician assisted suicide,
it had that right. But it did not have the right to change or amend an
existing federal law. If Oregon were to legalize the use of heroin for
any purposes that wouldn't change the federal law prohibiting its use.
The Controlled Substances Act is a federal law governing all 50 states,
not 49.
The Attorney General's letter carving out an exception for Oregon
to use federally-controlled substances for assisted suicide was in
direct opposition to her own Drug Enforcement Administration and is
also in direct conflict with 29 years of practice under the Controlled
Substances Act. Present law states these drugs can be used only for a
``legitimate medical purpose.'' The Pain Relief Promotion Act makes
clear, for the first time, that aggressive treatment of pain is a
legitimate medical purpose and provides new legal protections, and
additional safe harbor, for physicians to use these medications to
alleviate pain and discomfort. It also restates that the use of these
federally controlled drugs to cause death or assist in causing death is
not a legitimate medical purpose. The Pain Relief Promotion Act does
not overturn any state law. The bill does not tell States they can't
pass their own laws on assisted suicide--they can--it just clarifies
that those State laws have no effect on this long standing federal law.
The substitute amendment offered by Chairman Hatch goes even
further to clarify that the bill will neither pre-empt state laws or
standards for pain management and palliative care, nor allows states to
pre-empt Federal law regarding controlled substances. It also clarifies
that the Attorney General does not have the authority to create federal
standards (dosage requirements) for the practice of pain management and
palliative care. It makes certain that all types of pain including
acute, chronic, and end-of-life, can be addressed in the education,
research, and grant programs for pain management and palliative care.
Additionally, it highlights the importance of pain management and
palliative care by declaring the decade beginning in 2001 the ``Decade
of Pain Control and Research.''
The Pain Relief Promotion Act has strong bipartisan support with
currently, 42 cosponsors. In addition to the underlying support for the
bill the AMA has reaffirmed their support for the substitute amendment
and the Pain Care Coalition (made up of the American Pain Society,
American Academy of Pain Medicine, and American Headache Society) has
confirmed their support for the substitute. The Pain Relief Promotion
Act and the Chairman's substitute amendment gets the federal government
back in the business of caring for people in pain rather than
participating in causing their death. To date, over 42 people in Oregon
have died using federally controlled substances to cause their death.
It is time the federal government ends its involvement in this tragedy.
The Pain Relief Promotion Act is good for physicians, it is good for
patients and it is necessary to restore the federal law.
I ask your support for this bill and the substitute amendment, and
I thank you for the opportunity to appear before you this morning on
this critical issue.
______
Statement by Senator Don Nickles on S. 1272, the Pain Relief Promotion
Act
November 18, 1999
On June 23, 1999, Senator Lieberman and I introduced S. 1272, the
Pain Relief Promotion Act, which addresses two specific concerns.
First, it provides federal support for training and research in
palliative care. Second, it clarifies federal law on the legitimate use
of controlled substances. On October 27, 1999 the House passed its
companion measure H.R. 2260 by the resounding bipartisan vote of 271 to
156. It is my hope that the Senate will soon have the opportunity to
debate and vote on this important legislation.
In anticipation of that debate, and in light of inaccurate
characterizations of the second aspect of our bipartisan legislation, I
believe it is important for me to ensure that the Record reflects
precisely how this bill will--and will not--affect current federal law
with regard to Drug Enforcement Administration (DEA) oversight of the
use of federally controlled substances.
To understand the effect the Pain Relief Promotion Act will have on
pain control, we must begin with what the law is now. The Controlled
Substances Act (CSA) of 1970 charged the DEA with the responsibility of
overseeing narcotics and dangerous drugs--including powerful
prescription drugs which have a legitimate medical use but can also be
misused to harm or kill. In asserting its authority over these drugs,
Congress declared in the preamble of the Controlled Substances Act of
1970 that ``Federal control of the intrastate incidents of the traffic
in controlled substances is essential to the effective control of the
interstate incidents of such traffic'' (21 USC 801(6)).
In 1984, Congress amended the CSA due in part to a specific concern
regarding the misuse of prescription drugs in lethal overdoses. The
then Democratic-controlled House and a Republican Senate further
strengthened the Act, empowering the DEA to revoke a physician's
federal prescribing license if he or she uses it to endanger ``health
and safety'' regardless of whether the state law has been violated (21
USC 824, referencing 21 USC 823). The chairman of the Health
subcommittee in the House agreed: ``Drugs legally manufactured for use
in medicine are responsible for a substantial majority of drug-related
deaths and injuries'' (Rep. Waxman, Hearing of July 31, 1984, Hearing
Record No. 98-168, p. 365). Congress's view was that while the states
are the first line of defense against misuse of prescription drugs, the
federal government must have its own objective standard as to what
constitutes such misuse--and it must have the authority to enforce that
standard when a state cannot or will not do so. Congress's 1970 and
1984 decisions have been upheld time and time again by federal courts.
It is clear that federal law is intended to prevent use of these
drugs for lethal overdoses, and contains no exception for deliberate
overdoses approved by a physician. Nowhere in the Controlled Substances
Act has death or assisting death ever been considered a ``legitimate
medical purpose'' for use of these drugs. In the past, physicians who
were involved in the use of these drugs for suicide or other lethal
overdoses have lost their federal authority to prescribe controlled
substances on the grounds that they had endangered ``health and
safety.''
In 1997, Congress passed the Assisted Suicide Funding Restriction
Act of 1997 without a dissenting vote in the Senate and by an
overwhelming margin of 398-16 in the House. President Clinton stated in
signing the bill that ``it will allow the Federal Government to speak
with a clear voice in opposing these practices.'' He further warned
that ``to endorse assisted suicide would set us on a disturbing and
perhaps dangerous path.'' I would add only that authorizing a federal
agency to endorse the use of controlled substances for assisted suicide
would similarly ``set us on a disturbing and perhaps dangerous path.''
In November 1994, the State of Oregon adopted by referendum the so-
called ``Death with Dignity Act,'' allowing physicians to prescribe
medication for the purposes of assisting patients' suicides. The week
of that vote, Professor George Annas of Boston University pointed out
the inconsistency between the Oregon referendum and the Controlled
Substances Act in an article in the New England Journal of Medicine. He
questioned whether such a state law was compatible with existing
federal laws governing federally controlled drugs, ``since the drafters
of the federal statute certainly did not have this purpose [assisting
suicides] in mind.''
However, on June 5, 1998, overturning a previous determination by
her own DEA Administrator, the Attorney General issued a letter carving
out an exception for Oregon so it can use federally-controlled
substances for assisted suicide. She claimed that Congress did not
``intend to override a state determination as to what constitutes
legitimate medical practice in the absence of a federal law prohibiting
that practice.'' The Pain Relief Promotion Act will respond to the
Attorney General's challenge, by clarifying that the intentional misuse
of these drugs to cause patients' deaths is not authorized by Congress
in any state, nor has it ever been.
On October 27, 1997, Oregon's ``Death with Dignity Act'' became
effective. In the first year at least 15 patients have committed
suicide with doctor's assistance under the new Oregon law. We really do
not know the total number, because all reporting of cases is left
completely in the hands of the doctors themselves, and the Oregon
Health Division admits it has no idea how many unreported cases there
are. But regarding those 15 reported cases we know one thing: Every one
of those patient's' deaths was caused by a federally controlled
substance, prescribed with a federal DEA registration number, using
federal authority. Today, without any decision to this effect by
Congress or the President, the federal government is actively involved
in assisting suicides in Oregon.
To hear some of the critics of this bill you might think that the
Pain Relief Promotion Act creates a new authority on the part of the
DEA to revoke doctors' registrations if they use controlled substances
to assist suicide. On the contrary that authority has existed for 29
years and it exists now. Attorney General Janet Reno was very clear on
this matter in her letter of June 5, 1998: ``Adverse action under the
CSA may well be warranted . . . where a physician assists in a suicide
in a state that has not authorized the practice under any conditions,
or where a physician fails to comply with state procedures in doing
so.''
What does this mean for current law and practice? First, the DEA
has full authority to revoke a DEA registration for assisting suicide
in any of the 49 states where assisting suicide is not authorized by
state law. While critics of the Pain Relief Promotion Act have said
that empowering the DEA to investigate physicians in such cases will
have a ``chilling effect'' on the treatment of pain, the fact is that
such authority already exists in 49 states.
What about the one state, Oregon, where the Attorney General said
the DEA will not take adverse actions against physicians for assisting
suicide in compliance with the Oregon law? Even in Oregon many cases of
assisting suicide remain illegal under state law. The state law
authorizes assisting the suicide of those who are terminally ill, but
not others. Under the Attorney General's determination, then, the DEA
can continue to review cases of assisting suicide to make sure they do
not involve those who are not terminally ill, and it can scrutinize
whether a given use of pain medication was really intended to assist
suicide. All aspect of the Oregon guidelines for legally valid assisted
suicide are also subject to DEA investigation, since the Attorney
General has only authorized physicians to use federally controlled
drugs for assisted suicides when they fully comply with those state
guidelines.
Thus, as interpreted by the Attorney General, a registration to
prescribe federally controlled substances can be revoked under the
current Controlled Substances Act if these substances are used to
assist suicide in any state in the Nation, with the exception of
certain cases of assisted suicide that Oregon has legalized for the
terminally ill. If DEA scrutiny of doctors' prescribing practices were
going to ``chill'' the practice of pain control, that would already be
occurring under current law.
How does the Pain Relief Promotion Act impact this situation? It
establishes that, for the first time in federal law, the use of
controlled substances for the relief of pain and discomfort is a
``legitimate medical purpose,'' even if the large doses used in
treating pain may unintentionally hasten death. Intentionally causing
death or assisting in causing death remains forbidden. Thus this bill
does not increase the DEA's regulatory authority at all. On the
contrary, its only effect in 49 states (and even in Oregon, in cases
involving those who are not terminally ill) is to provide new legal
protection for physicians who prescribe controlled substances to
control pain.
In Oregon, this bill eliminates the Attorney General's artificial
exception designed to accommodate assisted suicides that are no longer
penalized under Oregon law. The DEA can meet its responsibility here
simply by looking at the reports required by Oregon law, in which
doctors must identify the drugs used to assist suicide. Those records
will make it clear whether federally controlled drugs were used; and
since the physician is clearly reporting that his or her own intent was
to help cause death, there will be no question of murky intentions or
ambiguity. Thus this bill will not lead to any increase in the DEA
trying to ``second guess'' or infer physicians' intentions, even in
Oregon.
What of any unreported cases in which physicians assist the
suicides of terminally ill patients? Those assisted suicides are
already a crime under Oregon law, and thus already subject to adverse
action by the DEA as well under the Attorney General's interpretation.
Only if a physician officially reports the case to the Oregon Health
Division is he or she exempted from state criminal penalties. So those
cases are already covered by the same DEA authority that currently
applies to assisted suicides in the other 49 states.
Let me take this situation step by step.
First, removing the Oregon exception to the existing nationwide
policy cannot increase any ``chilling effect'' on pain relief outside
of Oregon, because the bill does not increase one iota the authority of
the DEA to investigate the misuse of controlled substances to assist
suicide outside of Oregon. In fact, in those states its only effect is
to provide a more explicit ``safe harbor'' for the practice of pain
control, which is a significant advance and improvement for doctors and
terminally ill patients. This is also true of assisted suicide cases
within Oregon that do not comply with the state's reporting
requirements or other guidelines. In all these cases, the Pain Relief
Promotion Act gives the DEA no new mandate to investigate cases of
assisted suicide more directly. Rather, it is expected to follow its
longstanding practice of generally deferring to state authorities and
allowing them to take the lead in investigating possible wrongdoing.
Second, no new questioning of physicians' intentions is warranted
to address the cases of assisted suicide that are now permitted under
Oregon law. To be free of criminal penalties under state law in Oregon,
a doctor who assists a suicide must submit a report to Oregon
authorities that includes information on the drugs prescribed to assist
the suicide. The Drug Enforcement Administration (DEA) can obtain those
reports from the Oregon authorities. It already has the authority to
subpoena them, if necessary; again, our legislation has no impact on
this.
Thus, even in Oregon, this bill will not result in any increase in
DEA oversight or investigations of doctors based on their prescribing
patterns or the dosages they use for particular patients. This is
clearly stated in the House Judiciary Committee report on this bill, H.
Rep. 106-378 Pt. 1, pp. 12-13.
It follows that if this bill is enacted, any doctors in Oregon who
prescribe controlled substances for pain relief need not fear any
increase in DEA scrutiny of their practices, and therefore should not
in any way be deterred from prescribing adequate pain relief.
This bill cannot have a ``chilling effect'' on pain control, but
will have the opposite effect. For the first time, it will place in the
Controlled Substances Act, as the American Society of Anesthesiologists
notes, ``recognition that alleviating pain in the usual course of
professional practice is a legitimate medical purpose for dispensing a
controlled substance that is consistent with public health and safety,
even if the use of such a substance may increase the risk of death.''
The American Medical Association says this bill, ``provides a new and
important statutory protection for physicians prescribing controlled
substances for pain, particularly for patients at the end of life.'' As
the American Medical Association of Pain Management observes, this will
protect the ability of ``prescribers to relieve pain without fear of
regulatory discipline.''
Those who are concerned about the possibility of a negative impact
on pain relief if we pass this bill need to answer this question: do
they believe that NOW the Drug Enforcement Administration is having a
chilling effect on pain relief because federally controlled substances
cannot be used to assist suicide in 49 states and even, in many cases,
in Oregon?
If the answer, is ``no,'' then there is no basis to be concerned
about this bill--for this bill will not increase investigations or
oversight into the dosages of drugs used for pain relief, and in fact
instructs the DEA to be even more sensitive to physicians' need to
prescribe large doses of these drugs for pain control.
If the answer is ``yes,'' then there is a great need for this
bill--because for the first time it adds specific protections for
doctors who prescribe controlled substances for pain control-resulting
in a decrease in any ``chilling effect'' that may exist under current
law.
Let me quote from the American Medical Association. ``The bill
would not expand existing criminal penalties in the CSA for persons
whose unauthorized use of a controlled substance leads to someone's
death. . . . The bill would not expand the DEA's authority concerning
jurisdiction, investigations or enforcement regarding the CSA. In fact,
the inclusion of a recognition of the `double effect' in the CSA
provides physicians in all jurisdictions an additional statutory
protection in cases of alleged [physician-assisted suicide]. The bill
has the potential, through its educational provisions, of sensitizing
law enforcement personnel to the multiple issues of end-of-life care
and prescribing.''
It is noteworthy that although the Justice Department expressed
concern about the portion of the bill that would prevent the use of
federally controlled substances to assist suicide in Oregon, it agrees
that the bill would aid, and not hinder, pain relief. In a letter dated
October 19, 1999, the Justice Department wrote that the bill ``would
eliminate any ambiguity bout the legality of using controlled
substances to alleviate the pain and suffering of the terminally ill by
reducing any perceived threat of administrative and criminal sanctions
in this context. The Department accordingly supports those portions of
[the bill] addressing palliative care.''
This bill makes it easier, not harder, to use controlled substances
to relieve pain. That is why so many major medical organizations,
including the National Hospice Organization, the American Academy of
Pain Management and the American Society of Anesthesiologists, as well
as the AMA, strongly support its enactment.
Some may wish to abolish the Controlled Substances Act altogether.
They may think that the federal government's longstanding insistence on
monitoring the distribution of these powerful drugs is an unwarranted
intrusion into medical practice. I disagree with that stand, but at
least it can be understood as a consistent position. What is untenable
is the claim that this particular bill, which clearly improves the
law's sensitivity to medical judgments on pain control, somehow
mysteriously worsens that situation. Once we understand what the
current law is and what this bill does, that claim simply does not make
sense.
In short, the Pain Relief Promotion Act will foster pain control.
It will improve existing law by adding significant new legal
protections for physicians and pharmacists who prescribe and dispense
controlled substances for pain control. It will reduce, and in no way
increase, any possible ``chilling effect'' that could deter adequate
pain control. And by clarifying federal law so the federal government
will not facilitate the medical institutionalization of assisted
suicide in any state, this legislation may help discourage doctors from
simply suggesting assisted suicide instead of working to address their
patients' real problems of uncontrolled pain. As protectors of public
health and safety we should be encouraging doctors to kill the pain,
not the patient.
______
Drug Enforcement Administration,
Washington, DC, April 5, 2000.
Hon. Orrin G. Hatch,
Chairman, Committee on the Judiciary,
U.S. Senate, Washington, DC.
Dear Chairman Hatch: This is in response to your request for the
position of the Drug Enforcement Administration (DEA) on a proposed
amendment to the Pain Relief Promotion Act of 1999, H.R. 2260. This
amendment would raise the burden of proof in administrative hearings
involving physician-assisted suicide from the preponderance-of-the-
evidence standard to a clear-and-convincing evidence standard. DEA
opposes this amendment.
The imposition of the clear-and-convincing evidence standard would
be an abrupt departure from the standard of proof that has always been
applied in administrative cases under the Controlled Substances Act
(CSA). Starting with the enactment of the CSA in 1970, and continuing
to the present, Congress has mandated that proceedings to deny, revoke,
or suspend registration be conducted in accordance with the
Administrative Procedure Act (APA). Under the APA, the preponderance-
of-the-evidence standard is to be applied in administrative
proceedings. Steadman v. S.E.C., 450 U.S. 91 (1981). This standard,
along with the other procedural safeguards contained in the APA, has
been in effect for more than 50 years. DEA finds no reason to depart
now from this traditional approach.
DEA does not support the concept of applying different evidentiary
standards depending on the nature of the particular administrative
case, which is inherent in the proposed amendment. DEA believes that
the preponderance-of-the-evidence standard should continue to be
applied uniformly in all administrative cases. See 21 U.S.C.
Sec. Sec. 823(f), 824(a) (listing factors to be considered for denial
or revocation of registration).
Even in Oregon (the only state that expressly authorizes physician-
assisted suicide), the preponderance-of-the-evidence standard applies
in state medical licensing proceedings. See Gallant v. Board of Medical
Examiners, 159 Or.App. 175 (1999). This illustrates how the APA
standards properly remain the model for administrative proceedings
throughout the nation. H.R. 2260 does not alter the long-standing
federal requirement that controlled substances be dispensed only for a
legitimate medical purpose by a practitioner acting in the usual course
of professional practice. The bill simply makes clear that, in
determining whether a registration is consistent with the public
interest, the Attorney General (and DEA, by designation) ``shall give
no force and effect to State law authorizing assisted suicide or
euthanasia.'' Since Oregon is the only state with a law permitting
assisted suicide, DEA's authority to take administrative action in
every other state would not be changed by H.R. 2260.
There is no foundation to the allegations that if H.R. 2260 were
enacted DEA would seize the opportunity to investigate patient deaths.
It has always been state and local authorities who take primary
responsibility for investigating suspicious deaths. DEA has no plans--
and lacks the resources or expertise--to take this role from the state
and local authorities.
I also wish to comment briefly on the pain treatment aspect of H.R.
2260. As indicated in the bill, the issue of pain treatment is distinct
from the issue of physician-assisted suicide. I agree with and support
the provision of the bill which specifies that the dispensing of a
controlled substance to alleviate pain or discomfort in the usual
course of professional practice is a legitimate medical purpose, even
if the use of such substance may increase the risk of death.
I understand that there are some who have made the claim that this
law will make practitioners reluctant to dispense controlled substances
in the quantities required to properly treat pain. I want to emphasize
that DEA fully supports the effective treatment of pain. This is
clearly demonstrated by the fact that DEA has dramatically increased
the annual quotas for pain medications over the past ten years. During
this period,the morphine quota has been increased by a factor of 2.5,
fentanyl by a factor of 7.75, oxycodone by a factor of 3, hydromorphone
by a factor of 3.3 and hydrocodone by a factor of 3. In addition, DEA
has worked actively with the Federation of State Medical Boards in its
development of the Model Guidelines for the Use of Controlled
Substances for the Treatment of Pain. These guidelines were adopted on
May 5, 1998 and DEA fully supports them. I am concerned by statements
indicating that some groups do not understand our position on pain
relief. Members of my staff are available to meet with representatives
of these groups to discuss this critical health care issue.
If you have any additional questions, please contact me at (202)
307-8000.
Sincerely,
Donnie R. Marshall, Acting Administrator.
______
Verner, Liipfert, Bernhard, McPherson and Hand,
Washington, DC, February 9, 2000.
The Pain Relief Promotion Act (S. 1272) Introduced by Senator Don
Nickles
i. overview: pain relief act
The Pain Relief Promotion Act of 1999 (``Pain Relief Act''), S.
1272, introduced by Senator Nickles, amends the Controlled Substances
Act (the ``CSA''), 21 U.S.C. Sec. Sec. 801-971. The bill (1) explicitly
provides that controlled substances may be used for pain management and
palliative care; (2) clarifies existing federal standards concerning
assisted suicide and the use of controlled substances under the CSA,
but does not create any new federal standard; and (3) overrides
reliance on Oregon's Death With Dignity Act (Or. Rev. Stat.
Sec. Sec. 127.800-127.995 (1997), the ``Oregon Act'') and any other
similar state law as a defense to any action under the CSA related to
assisted suicide.\1\
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\1\ This memorandum examines the key elements of the Pain Promotion
Relief Act, as noted, and does not specifically analyze other
provisions such as those for education and training programs.
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ii. controlled substances act
The Controlled Substances Act provides authority for the Attorney
General of the United States to register and if appropriate revoke the
registration of manufacturers and distributors of certain controlled
substances ``consistent with the public interest.'' 21 U.S.C. Sec. 823
et seq. The Attorney General exercises her authority through the Drug
Enforcement Administration (``DEA''), 21 C.F.R. 1301.01(b)(3). In
determining the public interest, the Attorney General shall consider,
inter alia, the following factors: the use of controlled substances for
``legitimate medical purposes,'' ``compliance with applicable State and
local law,'' and other factors relevant to ``public health and
safety.'' 21 U.S.C. Sec. 823 et seq.
iii. the pain relief act allows controlled substances to be used for
palliative care
There is no provision in the current CSA that expressly protects
the use of controlled substances for palliative care, that is a drug or
medical treatment which relieves suffering without treating the cause
of the suffering (21 U.S.C. Sec. 802 (defining controlled substance)).
The Pain Relief Act includes an explicit provision providing that,
under the CSA,
. . . alleviating pain or discomfort in the usual course of
professional practice is a legitimate medical purpose for the
dispensing, distributing, or administering of a controlled
substance that is consistent with public health and safety,
even if the use of such a substance may increase the risk of
death.
S. 1272, Sec. 101 (first sentence of new paragraph 823(i)(1)).
This provision provides, in essence, a ``safe harbor'' for those
who dispense controlled substances for palliative care. It states
clearly that, for purposes of applying the CSA's public interest
standard, aggressive treatment of pain and discomfort is a legitimate
medical purpose even if it increases a patient's risk of death.
Recognizing the clear intent to provide a legal safe harbor, the
Department of Justice (DOJ) has stated that the Pain Relief Act:
. . . would eliminate any ambiguity about the legality of using
controlled substances to alleviate the pain and suffering of
the terminally ill by reducing any perceived threat of
administrative and criminal sanctions in this contact.\2\
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\2\ See letter from Robert Raben, Assistant Attorney General,
Department of Justice, dated October 19, 1999, to The Honorable Henry
J. Hyde (commenting on identical language in House legislation, H.R.
2260).
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iv. the pain relief act does not create a new federal standard
pertaining to assisted suicide
The Pain Relief Act, as noted in the section above, establishes a
new safe harbor that allows the dispensing of controlled substances for
the purpose of alleviating pain and discomfort even if it increases the
risk of death.
The next sentence in the same paragraph then sets forth a
limitation to the safe harbor. The Act provides:
Nothing in this section authorizing intentionally dispensing,
distributing, or administering a controlled substances for the
purpose of causing death or assisting another person in causing
death.
S. 1272, Sec. 101 (second sentence of new paragraph 823(i)(1)).
The second sentence, as drafted, clarifies that the safe harbor
should not be misinterpreted to provide a new federal standard to
authorize assisted suicide.\3\ In other words, as drafted, the sentence
only states what the section does not do (that is, to authorize
assisted suicide). The sentence does not purport to add any new
prohibition.\4\
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\3\ Statutes, including state laws dealing with end-of-life issues,
often use a similar construct to allow an activity but then limit its
interpretation. For example, the State of Washington, which has a
statute prohibiting assisted suicide, Wash. Rev. Code Sec. 9A.36.060
(1994), passed a Natural Death Act which specifically states that the
``withholding or withdrawal of life-sustaining treatment . . . shall
not, for any purpose, constitute a suicide.'' Then, to ensure that this
permissible activity is not misinterpreted, the statute provides that
``nothing in this chapter shall be construed to condone, authorize, or
approve mercy killing . . .'' Natural Death Act, RCW Sec. 70.122.100.
See Washington, v. Glucksberg, 117 S. Ct. 2258 (1997), upholding the
constitutionality of Washington's statute prohibiting assisted suicide.
Like the federal bill (S. 1272) at issue here, the proviso in the
Washington Natural Death Act that it does not authorize mercy killing
only serves to limit the interpretation of the permissible activity, it
does not provide a new state standard. For other state statutes with
similar constructs, see S.C. Code Sec. 44-77-130 (1999); 63 Okla. Stat.
tit. 63, Sec. 3101.12(G) (1999); Neb. Rev. Stat. Ann. Sec. 20-412(7)
(1999); 755 Ill. Comp. Stat. 40/50 (1999); Cal. Code Sec. 7191.5
(Deering 1999); Ark. Code Ann. Sec. 20-7-210 (1999).
\4\ If the authors of the legislation had intended to provide a new
federal statue prohibiting the use of controlled substances in assisted
suicide, they clearly could have done so by using prohibitive language.
Furthermore, if Congress intends to prohibit physician-assisted suicide
entirely, it could do so directly by enacting legislation making it a
federal crime. There is no fundamental right to commit or help another
to commit suicide. See Washington v. Glucksberg, 117 S. Ct. 2258
(1997).
---------------------------------------------------------------------------
The purpose and plain reading of this language is to provide that
the legislation does not add any new federal standard on assisted
suicide.\5\
---------------------------------------------------------------------------
\5\ As described in this section S. 1272 does not provide any new
federal standard relating to physician-assisted suicide under the CSA.
Accordingly, individuals covered by the CSA would not be subject to any
new liability for violations of it--with the exception of those who
would have relied on the Oregon Act as a defense to alleged violations
of the CSA. See infra Section VI.
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Revisions to Legislation Indicate Intent Not To Create New Federal
Standard Regarding Assisted Suicide
A careful comparison of the language in the Pain Relief Act,
introduced in the 106th Congress, and similar legisltion considered in
the 105th Congress is further evidence of the authors' intent not to
add any new federal standard on assisted suicide. Indeed, the changes
were made in direct response to concerns raised about the legislation
from the earlier Congress.
The legislation considered in the 105th Congress (H.R. 4006 and S.
2151) affirmatively provided that the Attorney General may suspend or
revoke registration under the CSA upon a finding that the registrant.
. . . has intentionally dispensed or distributed a controlled
substance with a purpose of causing, or assisting in causing,
the suicide or euthanasia of any individual, except that this
pragraph does not apply to the dispensing or distribution of a
controlled substance for the purpose of alleviating pain or
discomfort (even if the use of the controlled substance may
increase the risk of death), so long as the controlled
substance is not also dispensed or distributed for the purpose
of causing, or assisting in causing, the death of an individual
for any reason.
H.R. 4006, Sec. 2(b)(1); S. 2151, Sec. 3(b)(1).
This section could have been understood to provide a new
affirmative federal standard that a registration may be revoked if the
physician has assisted in a suicide using controlled substances
governed by the CSA. The language then, in a potentially confusing
manner, modified this new standard by stating that it would not apply
if the use of the controlled substances was for the purpose of
alleviating pain or discomfort (even if increasing the risk of death)
so long as it was not for the purpose of causing or assisting death.
By contrast, the Pain Relief Act introduced in the 106th Congress,
as described above, was completely redrafted to avoid creating a new
federal standard. Instead, the new legislation first provides a safe
harbor for the use of controlled substances in palliative care, and
only then carefully limits the application of the safe harbor without
creating any new federal standard on assisted suicide.
v. federal government has an established role with respect to
physician-assisted suicide
The federal government already has an established role and has
articulated policies with respect to physician-assisted suicide. As
detailed in the Solicitor General's amicus brief in Washington v.
Glucksberg there are various federal policies relating to physician-
assisted suicide in governmental institutions and ``no Federal law . .
. either authorizes or accommodates physician assisted suicide.'' \6\
Over the past two decades, there have been a series of federal cases
and congressional acts relating to physician-assisted suicide. In
particular, Congress adopted amendments to the CSA in 1984 that expand
the grounds on which the Attorney General may revoke a practitioner's
registration to dispense or conduct research with controlled
substances, to include instances where registration would be
``inconsistent with the public interest.'' 21 U.S.C. Sec. 824(a)(4).
This federal public interest standard has been applied by the DEA to
cases in which physicians prescribed drugs used in suicides in numerous
instances. Since 1980 the DEA has brought hundreds of enforcement
actions against registrants for violating the federal legal standard of
``legitimate medical purpose.'' See, e.g., 60 Fed. Reg. 56,354
(1995),\7\ 55 Fed. Reg. 4250 (1990),\8\ 55 Fed. Reg. 5306 (1990),\9\ 59
Fed. Reg. 46063 (1994).\10\ The Pain Relief Act does not expand the
DEA's current investigative or enforcement authority.\11\
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\6\ Brief for the United States as Amicus Curiae Supporting
Petitioners at 2, Washington v. Glucksberg, 117 S. Ct. 2258 (1997) (N.
96-110).
\7\ Physician prescribed a potentially lethal amount of Darvocet to
a depressed patient who used State law. His DEA application was denied
on the separate basis that his conduct threatened ``public health and
safety.''
\8\ State Board suspended physician's medical license and his
registration was revoked after patient under his care died from a
methadone overdose. DEA determined that physician violated the CSA and
demonstrated conduct which may further threaten ``public health and
safety.''
\9\ Physician prescribed Percodan for non-medical purpose to
several drug addicts, including one woman who overdosed on the
prescribed drugs. In revoking his registration, the DEA noted the
potential dangers of controlled substances and the the physician had
``failed to exercise such care, and as a result, has ignored his duties
as a health care professional to protect the public health and safety
from the illicit use of these drugs'' (55 Fed. Reg. 5307).
\10\ Physician's registration revoked because he prescribed Ritalin
and other drugs to drug addicts without a legitimate medical purpose.
One patient was prescribed anabolic steroids after revealing he had
taken them in the past, suffered from depression, and had attempted
suicide ten months earlier. Medical expert testified that it is
``medically dangerous'' to give anabolic steroids to a patient with
prior depression. DEA determined that his registration should be
revoked, nothing that his actions threatened public health and safety.
\11\ Section 102 of the Pain Relief Act provides for education and
training on the use of controlled substances for pain and the ``means
by which investigation and enforcement actions by law enforcement
personnel may accommodate such use.'' Such education and training does
not result in an expansion of DEA authority. As described above, DEA
officials have been reviewing the actions of physicians for years using
the ``public interest'' standard and providing continuing education to
law enforcement personnel has been critical function of the CSA.
Training DEA personnel, to ensure that actions they are already
authorized to undertake show appropriate deference to legitimate
medical practice, offers no evidence of increased authority under the
CSA.
---------------------------------------------------------------------------
In addition, in 1997 Congress adopted the Assisted Suicide Funding
Restriction Act (``ASFRA''), which provides that no federal funds may
be used, directly or indirectly, to provide any health care item or
service furnished for the purpose of causing or assisting in causing
the death of any individual, such as by assisted suicide, euthanasia,
or mercy killing and forbids using federal funds to advocate or promote
their legalization. 42 U.S.C. Sec. Sec. 14401-14408. President Clinton
emphasized that it ``will allow the Federal Government to speak with a
clear voice in opposing these practices,'' and cautioned that ``to
endorse assisted suicide would set us on a disturbing and perhaps
dangerous path.'' \12\
---------------------------------------------------------------------------
\12\ Statement by President William Jefferson Clinton Upon Signing
H.R. 1003, 33 Weekly Comp. Pres. Doc. 617 (May 5, 1997).
---------------------------------------------------------------------------
In several rulings, the Supreme Court has also discussed physician-
assisted suicide under federal law. See Washington v. Glucksbert, 117
S. Ct. 2258 (1997), United States v. Rutherford, 442 U.S. 544 (1979)
(addressing federal drug law policy to protect the terminally ill from
potentially lethal drugs); see also Vacco v. Quill, 117 S. Ct. 2293
(1997) (addressing physician's intent in physician-assisted suicide
cases).
As a result of these congressional acts and federal cases, there is
now an extensive history with respect to a federal role and federal
policies concerning physician-assisted suicide.
DOJ Interpretation of Physician-Assisted Suicide Under Existing
Controlled Substances Act
The Attorney General has recognized that the DEA already has the
authority to prevent the abuse of controlled substances for assisted
suicide. The Department of Justice (``DOJ'') has indicated, however,
that adverse action may not be taken under the Controlled Substances
Act, 21 U.S.C. Sec. Sec. 801-971, against a physician who has assisted
in a suicide in full compliance with the Oregon Act (``Reno Letter'' or
``DOJ Opinion'').\13\
---------------------------------------------------------------------------
\13\ See letter from Attorney General Janet Reno, dated June 5,
1998, to the Honorable Henry J. Hyde (``Reno Letter'' or ``DOJ
Opinion'').
---------------------------------------------------------------------------
In reaching this conclusion, the DOJ discusses existing federal law
with respect to a physician who has assisted in a suicide both in
Oregon and in states without a law comparable to the Oregon Act. In
both cases, the DOJ describes an existing federal role in analyzing the
propriety of the doctor's action.
Attorney General Reno states, in her letter,
* * * the CSA does not authorize [the Drug Enforcement
Administration (``DEA'')] to prosecute, or to revoke the DEA
registration of, a physician who has assisted in a suicide in
compliance with Oregon law. We emphasize that our conclusion is
limited to these particular circumstances. Adverse action under
the CSA may well be warranted in other circumstances: for
example, where a physician assists in a suicide in a state that
has not authorized the practice under any conditions, or where
a physician fails to comply with state procedures in doing so.
(emphasis added).
First, according to this statement, the DEA (that is, a federal
governmental entity) must, in applying the CSA to physicians in a state
such as Oregon, with a statute permitting physician-assisted suicide,
determine whether ``the physician fails to comply with the state
procedures'' in assisting in the suicide.
Second, this statement makes clear that the DEA may take action
against physicians assisting in a suicide in a state without a law
permitting physician-assisted suicide.
Both of these statements are in the context of existing law and
illustrate existing authority for the DEA to review physicians'
activities under the CSA.
In Applying the Federal Controlled Substances Act, the Pain Relief Act
Is Designed To Disregard Oregon's Death With Dignity Act or
Similar State Statutes
The Pain Relief Act in the 106th Congress provides that, in
applying the Controlled Substances Act, the Attorney General should not
take into consideration any state law permitting assisted suicide. In
effect, the legislation prevents action taken in accordance with
Oregon's Death with Dignity Act or other similar state law to serve as
a defense to action pursuant to the CSA. The legislation provides:
Notwithstanding any other provision of this Act, in
determining whether a registration is consistent with the
public interest under this Act, the Attorney General shall give
no force and effect to State law authorizing or permitting
assisted suicide or euthanasia.
S. 1272, Sec. 101.
The Pain Relief Act is designed to disregard the Oregon Act in
applying the Controlled Substances Act. This is one of the clear and
stated purposes of the Act.
By disregarding the Oregon Act, the Pain Relief Act ensures that
the Controlled Substances Act will be applied in the same manner to
those dispensing controlled substances in Oregon as those in all other
states.
Congress Has Authority To Regulate Controlled Substances and Preempt
Conflicting State Laws
Congress has been regulating controlled substances since 1970 and
has amended the CSA numerous times. Under the constitutional authority
of the Commerce clause, Art. I, sec. 8, cl. 3, the Federal government
has the power to regulate controlled substances and courts have
consistently upheld the constitutionality of the CSA (See, e.g., United
States v. Wacker, 72 F. 3d 1453, 1475 (10th Cir. 1996)).
Pursuant to the Supremacy clause of the Constitution, laws made
under such authority are legally superior to any conflicting provision
of a State law (U.S. Const. Art. IV). As the Supreme Court noted in Ray
v. Atlantic Richfield, ``even if Congress has not completely foreclosed
state legislation in a particular area, a state statue is void to the
extent that it actually conflicts with a valid federal statute'' (435
U.S. 151, 157 (1978)). Clearly, compliance with the Pain Relief Act
would make compliance with the Oregon Act impossible. Where such a
conflict exists, the Federal law is supreme. (Id.) Therefore, the
provision in the Pain Relief Act to override reliance on the Oregon Act
as a defense to any action under the CSA is constitutionally valid.
Don Lewis.
______
American Medical Association,
Chicago, IL, April 6, 2000.
Hon. Orrin Hatch,
Chairman, Committee on the Judiciary,
U.S. Senate, Washington, DC.
Dear Mr. Chairman: The American Medical Association (AMA) is
writing to convey our support for your Amendment in the Nature of a
Substitute offered to H.R. 2260, the ``Pain Relief Promotion Act.'' We
believe that your Substitute to the bill represents significant
improvements in addressing the continuing concerns of the physician
community regarding the proper roles of the state and federal
governments in regulating the practice of medicine.
The AMA, as you know, is squarely opposed to physician-assisted
suicide and believes it is antithetical to the role of physician as
healer. We strongly advocated against the Oregon public initiative that
has legalized physician-assisted suicide in the State. In crafting an
appropriate legislative response, physicians have been deeply concerned
that legislation must recognize that aggressive treatment of pain
carries with it the potential for increased risk of death, the so-
called ``double effect.'' The threat of criminal investigation and
prosecution for fully legitimate medical decisions is unacceptable to
the AMA.
Thus, we are very pleased to note that your bill would recognize
the ``double effect'' as a potential consequence of the legitimate and
necessary use of controlled substances in pain management, and
explicitly include this as a ``safe harbor'' provision for physicians
in the Controlled Substances Act. This is a vital element in creating a
legal environment in which physicians may administer appropriate pain
care for patients and we appreciate its inclusion.
Following passage of the original version of H.R. 2260 in the House
of Representatives, which the AMA supported, our physician membership,
represented by the AMA House of Delegates, expressed a number of
concerns about the bill. The AMA was directed by our House of Delegates
to work to specifically modify the bill in a way so as to preserve the
traditional role of the state in regulating legitimate medical practice
and preclude the federal government from establishing protocols for
pain management and palliative care.
We believe that the language of your Substitute includes essential
clarifications of the original bill, specifically expressing the
sponsors' intention to honor the existing authority of the states to
regulate legitimate medical practice, while exercising the concurrent
federal authority to regulate the prescribing and administration of
controlled substances. The language of the Substitute has been
carefully crafted to reflect this proper balance, and we believe that
it fully satisfies the concerns expressed by our House of Delegates. We
appreciate the efforts of the sponsors and the Committee staff in
working with the AMA and interested state and national medical
specialty societies to address physicians' concerns in this regard.
We also greatly appreciate the time and care demonstrated in
crafting a bill that makes a strong statement against assisted suicide,
while minimizing the potential for inappropriate federal intrusion into
patient care decisions.
Respectfully,
E. Ratcliffe Anderson, Jr., MD.
____
Pain Care Coalition,
Washington, DC, April 5, 2000.
Dear Senator: The Pain Care Coalition urges your support for the
Chairman's substitute to H.R. 2260 we understand will be offered in the
Judiciary Committee markup tomorrow.
The Pain Care Coalition is a national coalition that advocates for
responsible pain care policies at the federal level. The Coalition was
formed in 1998 by concerned organizations representing the interests of
pain care professionals and their patients. Constituent members of the
Coalition represent a broad spectrum of physicians and other health
care professionals involved in the diagnosis and treatment of patients
suffering from acute and chronic pain. Members also include those
professionals who conduct biomedical and related research into the
causes of pain and the effectiveness of diagnostic and therapeutic
approaches to freeing patients from pain or lessening the pain of those
who must live with it.
Questions concerning the Coalition may be directed to its
Washington Representatives, Bob Saner and Amy Bacon, at 202-466-6550.
Sincerely yours,
Joel R. Saper, MD, FACP, Chairman.
______
[From the Oregonian, Oct. 19, 1999]
A State's Rights, a State's Wrongs
not even oregon has a right to intrude on federal government's
traditional regulatory arena
Nobody can say Oregon didn't have a full debate on assisted suicide
before reaffirming in November 1997 what voters first passed a year
earlier. Both sides expended much blood and treasure in the fight and
it's natural to think the matter should end there. Oregon voters passed
assisted suicide; Oregon should have assisted suicide.
Normally, we'd agree.
But Oregon's ``Death with Dignity Act'' barges into an area of
long-standing federal jurisdiction--the Controlled Substances Act--and
Measure 16 proponents' new infatuation with ``states' rights'' betrays
a misunderstanding of the concept.
We mention this as Congress prepares to debate the Pain Relief
Promotion Act of 1999. The bill would authorize federal health-care
agencies to promote an improved palliative care, and not even our new
states' rights enthusiasts are grousing about that proposed federal
initiative. The Pain Relief Promotion Act also makes clear that
alleviating pain and discomfort is an authorized and legitimate medical
purpose for the use of controlled substances under the Controlled
Substances Act. Nobody minds this either, which is understandable,
since it would ensure that federal drug laws don't get in the way of
proper palliative care.
But the fur starts flying when the bill states that nothing in the
Controlled Substances Act authorizes the use of these drugs for
assisted suicide or euthanasia and that state laws allowing assisted
suicide or euthanasia are irrelevant in determining if a physician has
violated this federal law. Although the act wouldn't technically
nullify Oregon's suicide law, doctors here would have to help patients
die within the aid of federally controlled substances.
Initially, U.S. Drug Enforcement Administration Administrator
Thomas Constantine ruled that using controlled drugs such as
barbiturates to terminate patients violated the Controlled Substances
Act, because assisted suicide was not a ``legitimate medical
practice.'' We couldn't agree more that helping patients kill
themselves is not a ``legitimate medical practice.'' But in a later
decision, Constantine's boss, Attorney General Janet Reno, took a
different view.
She stated there was no evidence that Congress, in the Controlled
Substance Act, wanted to override the states' right to determine what
was a ``legitimate medical practice.'' Nor is there evidence, Reno
continued, that Congress intended to hand the DEA power to decide the
assisted suicide question.
A fair historical point. Congress probably couldn't imagine in 1969
that a state would countenance assisted-suicide using controlled
substances--but what about now? Reno said the DEA shouldn't decide if
physician-assisted suicide is a ``legitimate medical practice,'' and
that's a fair point, too. These issues, Reno stated, are fundamental
questions of morality and public policy.'' But does Congress have a
right to answer such questions in the context of the Controlled
Substances Act?
Absolutely.
These are drugs the federal government already controls. The
federal government wouldn't allow a state's doctors to dispense heroin
simply because a state legalized it. The federal government didn't
allow doctors to dispense marijuana even to terminally-ill patients--
just because a few states' voters deemed this a nifty idea. Congress
didn't even have to weigh in on medical marijuana; the administration
made that decision on its own, because of its worries about drug
addiction.
Clearly, Congress has every right to update or clarify U.S. law on
the use of federally controlled substances for assisted suicide. If
Congress can concern itself with drug addiction, surely it can--and
should--concern itself with the quality of health care across the
country.
It can--and should--concern itself with the effects of assisted
suicide on that health care.
And it can--and should--approve the Pain Relief Promotion Act of
1999.
[GRAPHIC] [TIFF OMITTED] T2844A.001
The Chairman. Senator Wyden.
STATEMENT OF HON. RON WYDEN, A U.S. SENATOR FROM THE STATE OF
OREGON
Senator Wyden. Thank you, Mr. Chairman. Mr. Chairman, the
obligatory part of any Senate hearing is that someone on my
side of the dais says nice things about the person on your side
of the dais who chairs the hearing.
The Chairman. You do not have to, Senator. [Laughter.]
I will alleviate that.
Senator Wyden. I want to talk about our 20 years together,
because if you scroll down the computer, you see our work, for
example, on the community health center legislation. The New
York Times said that was, in the 102d Congress, the most
important bill for low-income people. We made it possible for
hundreds of thousands of low-income citizens, you and I, with
your leadership, to get good health care without costing the
taxpayer a penny.
So one of the reasons that I come today with so much regret
is that I have asked your counsel on health care issues since I
was a young member of the House on the Waxman committee
specializing in health, and because I so value your counsel and
input is why I have so much regret that I come today to say
that I am especially concerned that the substitute is going to
undermine so much of the work that you have championed that
provides effective and human health care for the millions that
suffer in this country.
I have said it before but I would like to repeat it. I
strongly oppose physician-assisted suicide. I voted against the
Oregon ballot measure twice. As the former Director of the
Oregon Gray Panthers, I witnessed firsthand how the poor and
the vulnerable so often receive inadequate health care. I have
long been worried about the adequacy of the Oregon ballot's
measure to protect those who are poor, especially the poor
elderly.
In addition, my religion, my views as a Jew have taught me
about the infinite value of human life. Rabbi Bleich is going
to testify soon. He is certainly more learned than I on these
matters, but rabbis from the Orthodox to the Reform continually
stress that life's value is infinite, while at the same time
they emphasize that every responsible measure ought to be taken
to comfort the ill.
For a variety of these personal, moral, and religious
reasons, I did vote against the Oregon ballot measure, and as a
Senator, I voted against using Federal funds for assisted
suicide.
If there were a significant constitutional issue at stake
or another compelling national interest, or had the people in
my State acted in haste and without adequate examination and
debate, I would not be such a strong defender of the Oregon
law. Those issues are not present here. The Supreme Court has
made it clear that States have the right to either ban or
authorize assisted suicide without impinging on any
constitutional protections.
Further, no one has said that my State acted precipitously.
We had two lengthy and exhaustive debates that dominated the
water coolers and dinner tables of the people of my State for
two years.
Mr. Chairman, I recognize that others sincerely view this
issue differently, but I firmly believe that my election
certificate does not give me the authority to substitute my
personal and religious beliefs for the judgment made twice by
the people of Oregon. The States have always possessed the
clear authority to determine acceptable medical practice and
acceptable medical uses of controlled substances and I am going
to fight with all my strength to preserve Oregon's rights on
this matter.
Today, however, the committee need not confront the issue
of whether Oregon has the right to choose its own course on
physician-assisted suicide. As you touched on in your opening
statement, every member of the Senate agrees that there is a
strong national interest in reducing the demand for physician-
assisted suicide. If we can agree on that issue, the
legislation that is offered today should be rejected, but a
bipartisan bill that I wrote with the leadership of Senator
Mack and Senator Smith should be passed to help the suffering.
Despite the well-intentioned efforts that you have, Mr.
Chairman, and your sincerity, nothing really changes in my
reading of the substitute. Your bill would authorize local,
State, and Federal law enforcement officials without expertise
and training in health care to dissect a physician's intent
with respect to prescribing pain relief medicine. It would
allow the Federal Government to intrude into the doctor-patient
relationship at one of the most difficult and personal times of
an individual's life. Despite the language that was included
concerning the State's role, the effect would be the same.
Physicians' fear of being investigated by law enforcement and
losing their ability to practice medicine is going to result in
less-aggressive pain relief for countless patients.
``The New England Journal of Medicine,'' in their editorial
against these legislative approaches that would overturn
Oregon's law, said, ``Many doctors are concerned about the
scrutiny they invite when they prescribe or administer
controlled substances and they are hyper-sensitive to drug-
seeking behavior in patients. Patients, as well as doctors,
often have exaggerated fears of addiction and the side effects
of narcotics.'' The New England Journal of Medicine, Mr.
Chairman, said, and I quote, ``Congress would make this bad
situation worse.''
Allow me for a moment to give this situation some
proportion. I hope that the committee will consider that this
bill will sentence millions of patients and communities across
this country to needless suffering to stop several dozen
terminally ill Oregonians whose personal and religious beliefs
are different from yours and mine.
Now, some with the argument of straight States' rights use
the Controlled Substance Act when attempting to explain their
support of a new approach to federalism as it relates to the
State of Oregon. They assert that the Federal role in
overturning Oregon's law is self-evident because controlled
substances are regulated under Federal law and enforced by a
Federal agency. As someone who has spent decades now studying
pharmaceutical and drug issues, I strongly believe that this
analysis misses the point.
It is true that the Federal Government controls drugs
through the Controlled Substance Act for the purposes of
preventing and detecting illegal diversion, sale, and abuse.
The Federal Government does have an appropriate role there in
regulating the distribution of controlled substances. But when
it comes to determining a legitimate medical purpose of these
controlled substances, these drugs have always fallen under the
supervision of the States.
States regulate the use of controlled substances through
the individual medical practice acts, pharmacy practice acts,
medical board regulations, and pharmacy board regulations. Many
States even have their own intractable pain acts regulating the
use of controlled substances. These States approach the issue
differently, but the bottom line is that they have focused on
the medical practice issue without disturbing the Federal
Government's jurisdiction over the unauthorized, abusive
diversion or sale of drugs.
If we are to decrease the demand for physician-assisted
suicide, we have got to address the reasons why people seek
this option. I am frankly astounded at the horrendous job that
is now done to relieve the needless suffering of sick and dying
patients. The under-treatment of pain, Mr. Chairman, is a well-
documented public health crisis in this country and I believe,
tragically, one of the unintended consequences of this bill is
that this substitute is going to compound the under-treatment
of pain across this nation.
As you know because of our conversations, I very, very much
want to work in a bipartisan way on this issue. My whole
approach for 20 years, Mr. Chairman, has been to work in a
bipartisan way, whether it is health care, whether it is
technology, whether it is trade. That has been the calling card
of my approach for more than 20 years. That is why I think that
the legislation that Senator Mack, Senator Smith and I
developed makes sense, because it will allow us to improve pain
relief in every nook and cranny of this country without causing
problems that are going to cause physicians in every part of
this nation to have second thoughts before they reach for their
prescription pad, which is what I think the practical effect of
the substitute will be.
Mr. Chairman, I have challenged the Oregon health community
to develop a model for hospice care so we can provide better
care for the dying. The evidence clearly shows that when people
have access to good hospice care, they are less likely to seek
physician-assisted suicide. That is what the bipartisan bill
with Senators Mack and Smith does. In addition to that
legislation, I have worked with Senators Grassley and Breaux to
review, and the GAO is doing so now, barriers to hospice care
around the nation. The vast majority of Americans do not even
know what hospice care is, nor do they get the full six-month
benefit available to them through the Medicare program.
We should recognize that if the Pain Relief Promotion Act
were to pass, demand for physician-assisted suicide would still
exist because the bill fails to address the reasons that
currently drive people to seek this option.
Finally, Mr. Chairman, I point out that regardless of where
a person stands on the issue, the evidence suggests that Oregon
is doing a far better job of providing safeguards to the
terminally ill than is the rest of the country. The Oregon law
requires examinations by physicians and mental health
professionals to ensure that an individual who seeks assisted
suicide is not only terminally ill and facing imminent death
but of competent mind. What has gone unreported in this debate
are thousands of physician-assisted suicides that have gone on
in this country for many years without the safeguards that we
see in the Oregon statute, and I would refer to several
studies, Mr. Chairman, in my prepared remarks that highlight
that particular point.
Again, I thank you for holding this hearing. I hope that we
can set aside, Mr. Chairman, the substitute, work together as I
have sought to do with Senators Mack and Smith. And by the way,
for the record, when I began this effort, I went to Senator
Nickles. I went to Senator Nickles and asked him to work
together with me to try to find a common ground.
But, obviously, today we have differences of opinion, but
the stakes are too important and too high to move precipitously
under political duress. I would like to wrap up by asking for
inclusion in the record of a statement in opposition to the
substitute by the American Academy of Family Physicians. They
represent over 89,000 family physicians and residents
nationwide. They oppose the substitute. I would ask that their
statement and a legal analysis by the Oregon Medical
Association, a letter of opposition by more than 40 leading
bioethicists, a statement by the American Pharmaceutical
Association that evaluates the legislation, and a statement by
the Oregon Hospice Association be made a part of the record, as
well.
I thank you, Mr. Chairman.
The Chairman. Without objection, we will put that in the
record.
[The information of Senator Wyden follows:]
Prepared Statement of the American Academy of Family Physicians
This statement is submitted to the Senate Judiciary Committee in
opposition to H.R. 2260, the Pain Management Promotion Act, by the
American Academy of Family Physicians. The Academy represents 89,4000
practicing family physicians, family practice and medical students.
H.R. 2260 passed the House of Representatives on October 27, 1999
by a vote of 271-156. The intent of H.R. 2260, The Pain Relief
Promotion Act of 1999, is to prevent federally controlled substances
from being used in an assisted suicide. H.R. 2260 clarifies that the
use of federally controlled narcotics to control pain is acceptable,
and recognizes that the legitimate use of narcotics may increase the
risk of death. The bill also clarifies that the use of controlled
substances to assist in a suicide is illegal. The Academy opposed
passage of H.R. 2260 by the House and remains opposed to passage in the
Senate.
The Academy opposes physician assisted suicide as being
fundamentally inconsistent with the physician's role as a healer. The
Academy opposes H.R. 2260, not because it attempts to outlaw physician
assisted suicide, but because in its attempt to do so, it may put at
risk for criminal investigation physicians who are aggressively and
appropriately prescribing narcotics to patients who are in great pain.
Specifically, the measure calls for the Drug Enforcement Administration
(DEA) to train its agents on how to determine whether the death of a
patient was a result of physician assisted suicide, utilizing various
sets of guidelines. Assessments by non-medical personnel of physicians'
clinical management of patients is likely to result in the questioning
of appropriate treatment regimens provided by well trained physicians
acting in the best interest of their patients who are suffering severe
pain. Such scrutiny of physicians, performed within the construct of
DEA authority by DEA agents, may well create a chilling environment for
the physician whose goal is appropriate medical treatment of a
patient's pain.
Chairman Hatch (R-UT) has drafted a substitute measure in an
attempt to address the concerns of the medical community. Although
Chairman Hatch's substitute is an improvement over the House-passed
version of H.R. 2260, the Chairman's mark retains objectionable
provisions.
In particular, Sec. 102 of H.R. 2260 and Sec. 202 of the Chairman
Hatch's mark would allow training of federal, state, and local law
enforcement personnel on how to conduct investigations and enforcement
actions involving controlled substances prescribed for pain management
at the end of life. Such training would incorporate the recommendations
of the Secretary of Health and Human Services. Training law enforcement
officers who have no clinical education in medical decision making to
review complicated end-of-life care decisions invites misunderstanding
and misidentification of violations. Such training is also a way to
redirect officers from their emphasis on drug traffickers to second-
guessing physician decisions on pain management. For these reasons, the
Academy opposes the Chairman's mark.
We would note, however, that the Chairman's mark does contain
language that makes it preferable in some areas to the House-passed
version of H.R. 2260. Specifically, the following sections are
improvements over the House-passed bill:
Section 2. Findings (5) (page 2): This section finds that
``adequate treatment of pain, especially for chronic diseases and
conditions, irreversible diseases such as cancer, and end-of-life care,
is a serious public health program affecting hundreds of thousands of
patients every year; physicians should not hesitate to dispense or
distribute controlled substances when medically indicated for these
conditions.'' This language could be improved further by including the
phrase, ``in the quantities necessary.''
Title I Section 903(a) (page 3): This section emphasizes that the
Agency for Healthcare Research and Quality may not develop national
pain management standards, a change requested by this organization.
Title II(a) (page 9): This section makes clear that states retain
the sole discretion with respect to the licensure of physicians and
state prescribing privileges. There has been concern that this act
creates a kind of national de facto licensure, to the extent that
prescribing controlled substances is essential to practice.
Title II(a)(4)(B) (page 9) Prohibits the Attorney General from
issuing national standards for pain management.
Title II(b)(2) (page 10) Represents perhaps the most important
improvement in the draft. It increases the burden of proof greatly in
any Department of Justice or Drug Enforcement Administration
administrative, or civil, action against physicians accused of causing,
or assisting in causing the death of a patient. The Attorney General
has the burden, under this section of ``proving, by clear and
convincing evidence, that the practitioner's intent . . . was causing
death or assisting another person in causing death.''
Despite the above noted improvements, however, the substitute
proposal retains the objectionable elements of H.R. 2260, which are the
basis for the Academy's opposition to passage of the legislation.
Legislation such as H.R. 2260, or modifications to it like the
Chairman's mark, may result in further government interference into
clinical decision making, and may potentially subject physicians
treating patients appropriately to scrutiny by DEA agents utilizing a
set of government guidelines to assess medical practice. The American
Academy of Family Physicians cannot support legislation that may create
an environment in which physicians are fearful of treating their
patients appropriately. Therefore, the Academy urges that the Judiciary
Committee not support H.R. 2260 or the Chairman's mark.
______
Oregon Medical Association,
Portland, OR, April 21, 2000.
Hon. Orrin Hatch,
Washington, DC.
Dear Senator Hatch: The Oregon Medical Association has been
informed that the Senate Judiciary Committee will hold a hearing on the
Pain Relief Promotion Act on April 25th, 2000. I respectfully request
that the Oregon Medical Association Counsel's analysis of the Act be
included in the record of the Judiciary Committee's hearing.
Sincerely,
Richard Kincade, MD, President.
______
Law Offices of Cooney & Crew, P.C.,
Portland, OR, April 10, 2000.
Re: proposed substitute text to Pain Relief Promotion Act of 1999.
Scott Gallant,
Director of Government Affairs,
Oregon Medical Association, Portland, OR.
Dear Scott: I have reviewed Senator Hatch's proposed substitute
text (``Hatch's Substitute'') for the Pain Relief Promotion Act of 1999
(``PRPA'') which amends Section 303 of the Controlled Substances Act,
21 USC Sec. 823 (``CSA''), and provided below a brief analysis of the
changes. As you probably know, some of the changes contained in the
Hatch Substitute follow the proposed language of the American Medical
Association's (``AMA's'') Working Draft Amendments to U.S. Senate Bill
1272, PRPA, which we reviewed earlier and are of the significant
concern. On the other hand, a number of changes, including those to
Title I, Sections 101 through 104 of the PRPA, are not substantive
beyond adding the terms ``pain and'' to the Act's references to
palliative care and expanding the definition of such care.
In my previous analysis of the AMA's Working Draft Amendments to S.
1272 (AMA HOD; I-99), I discussed the fact that the proposed AMA
language would not eliminate federal intrusion into standard of care
issues. In addition, we have expressed our concerns on previous
occasions about the PRPA leaving the door open for the federal
government to second guess physicians' prescribing practices. By
attempting to define, regulate and enforce the meaning of a
``legitimate medical purpose,'' the PRPA expands the Drug Enforcement
Agency's (``DEA's'') authority to question a physician's decision in
prescribing controlled substances. Under the PRPA, the DEA can initiate
intrusive and time-consuming investigations into physicians decisions
regarding pain and palliative care, whether the physician acts are
consistent with state laws (regarding pain or other standards) and
regardless of whether the physician's patient dies. We believe the
increased federal scrutiny would have a chilling effect on physicians'
willingness to engage in necessary, sometimes aggressive, sometimes
innovative approaches to pain care.
The Hatch Substitute, like the AMA's Working Draft Amendments, does
nothing to alleviate our concerns over heightened federal scrutiny and
intrusion into the practice of medicine. Although the language appears
to leave intact the State's independent authority to decide questions
on scope and standards of medical care, the Hatch Substitute
effectively strengthens the federal governments authority in such
instances.
The Hatch Substitute adds the following language to Title II,
Section 201 of the PRPA:
``(i)(3) Nothing in this subsection shall be construed to
alter the roles of the Federal and State governments in
regulating the practice of medicine. Regardless of the whether
the Attorney General determines pursuant to this section that
the registration of a practitioner is inconsistent with the
public interest, it remains solely within the discretion of
State authorities to determine whether action should be taken
with respect to State professional license of the practitioner
or the privileges of the practitioner to prescribe controlled
substances in the State.''.
The above language apparently attempts to maintain the current roles of
federal and state authorities with respect to the practice of medicine.
This provision leaves intact, however, only states' discretion with
respect to a practitioner's state license or state prescribing
privileges. The added language, when viewed in the context of reality,
is meaningless. In Oregon, as in all other states, the right to
prescribe controlled substances is predicated on the physician holding
a ``current DEA registration.'' If the federal government should find
the practitioner in violation of the PRPA, it is quite likely that the
DEA would revoke the physician's registration which in turn would
eliminate the doctor's right under state law to issue script for
federally controlled substances. It is our experience that the effect
on a physician's practice of losing prescribing privileges is career-
ending.
The Hatch Substitute further provides
``(i)(4) Nothing in the Pain Relief Promotion Act of 2000
(including the amending made by such Act) shall be construed--
``(A) to modify the Federal requirements that a
controlled substance be dispensed only for a legitimate
medical purpose by a practitioner acting in the usual
course of professional practice,''.
In contrast to Section (3) above which allows states to
independently enforce their own licensing and prescribing rules and
regulations, Section (4)(A) reiterates the federal government's
authority to investigate and decide questions of what is or is not a
legitimate medical purpose and what is the usual course of medical
practice in the context of federal legislation for prescribing
controlled substances. As such, a physician may not be disciplined
under State rules for a particular course of treatment, but may be
subject to criminal penalties and loss of registration under the
federal rules for the exact same conduct.
Section (4)(B) of the Hatch Substitute also appears to limit
federal authority by stating that nothing in the PRPA shall be
construed:
``(B) to provide the Attorney General with the
authority to issue national standards for pain
management and palliative care clinical practice,
research, or quality''.
The Attorney General may not codify or promulgate ``national
standards'' or protocols regarding pain and palliative care under the
proposed regulation, but may nonetheless impose her own set of
standards (through enforcement personnel with little or no expertise in
the provision of plain or palliative care) in deciding, on a case-by-
case basis, the fate of individual physicians prescribing controlled
substances for pain care.
Moreover, the language at the end of Section (4) ``except that the
Attorney General may take such other action as may be necessary to
enforce the Act'' leaves little doubt that a state's ability to
determine and enforce its own guidelines and standards for pain care is
subject to federal authority. This broad language, which makes the PRPA
internally inconsistent with the above language, essentially vitiates
any of the PRPA's language that appears to empower or maintain a
state's authority to regulate the practice of medicine within its own
borders.
Identical to the AMA's proposed Amendment #3 to the PRPA (which
amends Section 304(c) of the Controlled Substances Act), the Hatch
Substitute also proposes to add the following language to the PRPA:
``(2) Burden of proof.--At any proceeding under paragraph (1)
where the order to show cause is based upon the alleged
intentions of the applicant or registrant to cause or assist in
causing death, the Attorney General shall have the burden of
proving, by clear and convincing evidence, that the
practitioner's intent was to dispense or distribute a
controlled substance with a purpose of causing or assisting in
causing, the suicide or euthanasia of any individual. In
meeting such a burden, it shall not be sufficient to prove that
the applicant or registrant knew that the use of the controlled
substance may increase the risk of death.''
We remain concerned that this language put a physician's state of mind
at the center of any DEA investigation regarding that physician's
treatment for pain care. If someone believes a physician acted for the
wrong purpose, the physician will have to defend his or her state of
mind at the time of treatment, and because indirect and circumstantial
evidence of one's state of mind is not always reliable, a physician
with no intent to assist in a patient's death could be found to have
violated the PRPA if the trier of fact believed the testimony of
witnesses who testified as to what they believed or perceived the
physician's state of mind [intent] to be.
Under the proposed Bill, the line between acceptable palliative or
pain care and unacceptable assisted suicide rests solely on the
physician's intent. When intent is the critical issue, physicians must,
and will, worry that law enforcement officials will see a criminal
intent even where none existed. Physicians, under the PRPA, put not
only their registration at risk, but also face possible criminal
prosecution if determined to have possessed the wrong kind of intent.
Physicians will likely err on the side of more caution in treating
pain, with the possible result that tens of thousands of patients will
die without adequate pain or palliative care, possibly subjecting
physicians to civil liability for defensive treatment decisions.
In summary, the Hatch Substitute's apparent attempt to maintain
state authority vis-a-vis the federal government is illusory. The
federal government retains the ability to define, regulate, and enforce
on a case-by-case basis, questions of whether a physician's actions and
intent meet federal requirements that a controlled substance be
dispensed only for a legitimate medical purpose by a practitioner
acting in the usual course of professional practice.
Sincerely,
Steven T. Conklin.
______
Law Offices of Cooney & Crew, P.C.,
Portland, OR, July 9, 1999.
Re Federal Pain Relief Promotion Act of 1999.
Mr. Scott Gallant,
Director of Governmental Affairs,
Oregon Medical Association, Portland, OR.
Dear Scott: The purpose of this correspondence is to follow up on
our initial June 23, 1999 analysis of the Federal Pain Relief Promotion
Act of 1999 (S. 1272) which was introduced by Senator Don Nickles (R-
Okla.) on June 23, 1999. A similar version was introduced in the House
of Representatives by Representative Henry Hyde (R-Ill.) (H.R. 2260).
The main purpose of these bills is to define when dispensing pain
medication is a legitimate medical purpose and to prohibit dispensing
of controlled substances for the purpose of causing the death of an
individual. Contrary to earlier opposition of similar proposed
legislation, the American Medical Association (AMA) apparently supports
passage of this particular bill. Consequently, you wanted to know
whether the current legislation proposal radically differs from earlier
bills addressing this issue (which would explain the AMA's change in
position), or is the AMA now simply contradicting earlier statements
which questioned the authority of the federal government to regulate
directly the practice of medicine.
question presented
Does the Pain Relief Promotion Act of 1999 raise similar legal
issues regarding the authority of the federal government to regulate
the practice of medicines as did the Lethal Drug Abuse Prevention Act
of 1998?
short answer
Compared to earlier proposed legislation, the current legislation
proposal to amend the Controlled Substances Act raises similar legal
issues regarding the authority of the federal government to regulate
the practice of medicine.
Discussion
In July 1998, members of Congress debated the Lethal Drug
Abuse Prevention Act which would have prohibited the dispensing
of a controlled substance with a purpose of causing the suicide
of an individual.\1\ At the time, the AMA testified in
opposition to the bill before a House subcommittee. The main
concerns voiced by the AMA were that the bill might discourage
appropriate aggressive palliative care and that the legislation
represented an unacceptable federal intrusion of the DEA into
state regulation of the practice of medicine.\2\
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\1\ HR 4006, 105th Congress, 2d Session (Jun. 5, 1998).
Specifically, the bill would have amended the Controlled Substances Act
to state that a physician's Drug Enforcement Administration (DEA)
license could be revoked upon a finding that the physician:
has intentionally dispensed or distributed a controlled
substance with a purpose of causing or assisting in
causing, the suicide or euthanasia of any individual,
except that this paragraph does not apply to the dispensing
or distribution of a controlled substances for the purpose
of alleviating pain or discomfort (even if the use of the
controlled substances may increase the risk of death), so
long as the controlled substance is not also dispensed or
distributed for the purpose of causing, or assisting in
causing, the death of an individual for any reason.
(Emphasis added.)
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\2\ Hearing on HR 4006, before the Subcommittee on the Constitution
of the House Committee on the Judiciary (Jul. 14, 1998) (presented by
Thomas R. Reardon, MD). With respect to palliative care, the AMA stated
that:
[U]nder the terms of H.R. 4006, aggressive drug therapies
for pain management will become automatically suspect.
Physicians are only human and will go to great lengths to
avoid a Department of Justice investigation . . . as anyone
would. A Department of Justice investigation, which under
the terms of this bill could be instigated by any
individual, could result in physician's (1) loss of federal
DEA license for prescribing controlled substances; (2)
exclusion from participation in the Medicare and Medicaid
programs; and (3) possible criminal prosecution. The is no
question but that H.R. 4006 would effect physician
decision-making and have the perverse effect of chilling
---------------------------------------------------------------------------
appropriate palliative care.
Regarding the proper roles of state and federal government, the AMA
concurred with the Attorney General's June 5, 1998 opinion which
provided that neither the language of the Controlled Substances Act or
its legislative history supported the Act's application to physicians
who are in compliance with state law. The AMA stated that:
Any other reading makes the DEA an arbiter of the practice
of medicine. This is unacceptable conclusion. It is the
state legislatures, through the police powers, that
determine the scope of medical practice. State medical
boards are universally authorized by their state statutes
to investigate reports of improper prescribing as possible
evidence supporting suspension or revocation of a
physician's license to practice medicine. This is the
proper purview of the state.
Now in 1999, Congress is revisiting this issue with the
Pain Relief Promotion Act. While not identical to earlier
legislative proposals, the bill effectively has the same
effects. The Controlled Substances Act would be amended to
state that alleviating pain or discomfort is a legitimate
medical propose for dispensing, distributing, or administering
controlled substances, but the bill would not authorize
intentionally dispensing, distributing or administering
controlled substances for the purpose of causing death.\3\
Simply put, the bill would prohibit the current legal practice
of prescribing controlled substances pursuant to Oregon's Death
With Dignity Act.
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\3\ S. 1272, 106th Congress, 1st Session (Jun. 23, 1999). Instead
of amending the provision which sets forth grounds for disciplinary
action (as with former H.R. 4006). this bill would amend the
registration requirements for a DEA license to state:
For purposes of this Act and any regulations to implement
this Act, alleviating pain of discomfort in the usual
course of professional practice is a legitimate medical
purpose for the dispensing, distributing, or administering
of a controlled substance that is consistent with public
health and safety, even if the use of such a substance may
increase the risk of death. Nothing in this section
authorizes intentionally dispensing. distributing, or
administering a controlled substances for the purpose of
causing death or assisting another person in causing death.
---------------------------------------------------------------------------
(Emphasis added.)
As a direct attempt to preempt Oregon's law, the bill states:
Notwithstanding any other provision of this Act, in
determining whether a registration in consistent with the
public interest under this Act, the Attorney General shall
give no force and effect to State law authorizing or
permitting assisted suicide or euthanasia.
Finally, the education provisions of the Controlled Substances Act
would be expanded to include programs:
[f]or local, State and Federal personnel . . . on the
necessary and legitimate use of controlled substance in
pain management and palliative care, and means by which
investigative and enforcement actions by law enforcement
personnel may accommodate such use.
Upon introduction, Senator Nickles indicated that the House
of Delegates of the AMA voted to support the bill.\4\ Because
the current legislative proposal to amend the Controlled
Substances Act raises similar legal issues as those found in an
earlier bill directly opposed by the AMA, the AMA appears to
have departed from its views which sought to protect
appropriate palliative care and support the role of the states
in determining the scope of the practice of medicine. Both the
threat against appropriate palliative care and the traditional
role of the states remain in the current bill.
---------------------------------------------------------------------------
\4\ Statement on Introduction of Pain Relief Promotion Act of 1999
(Sen. Nickles) (Jun. 23, 1999).
---------------------------------------------------------------------------
With respect to palliative care, the authority of the DEA
to regulate the legitimate use of controlled substances would
be expanded under the 1999 Act. Specifically, the Act provides
that alleviating pain in the usual course of professional
practice is a ``legitimate medical purpose,'' and authorizes
agency rulemaking to implement this new federal definition.
Furthermore, the Act creates programs to train law enforcement
personnel (both federal and nonfederal personnel) on the
``legitimate use of controlled substances in pain management.''
A logical consequence of such federal expansion into
determining standards of care for pain management would be
closer scrutiny of clinical decisions to administer pain
medication when those decisions may increase the risk of death
in order to provide adequate comfort of the patient. As the AMA
rightly pointed out in 1998, physicians may think twice about
aggressive drug therapies for pain management due to fear of
federal investigations. The AMA also pointed out that states
are beginning to adopt guidelines for palliative care and this
type of proposed legislation could undo such efforts.\5\ What
would happen if a state's legislative standards regarding
palliative care conflicted with rules adopted by the DEA? At
the very least, a debate would be created about the preemption
of the state standards by the federal standards.
---------------------------------------------------------------------------
\5\ See, e.g., ORS 677,474 (stating that a physician shall not be
subject to disciplinary action by the Board of Medical Examiners for
prescribing or administering controlled substances in the course of
treatment of a person for intractable pain).
---------------------------------------------------------------------------
With respect to state regulation of the practice of
medicine under this 1999 Act, the federal Department of Justice
(through the DEA) clearly would become involved in the creation
and enforcement of rules governing when dispensing pain
medication is a legitimate medical purpose.\6\ Furthermore, the
Act specifically instructs the Attorney General to ignore state
law.\7\ Granted the main consequence of the Act effectively
would prohibit physician-assisted suicide in Oregon, but
another consequence would be that the federal government may
create pain management standards that directly conflict with
existing state efforts to address palliative care. In theory,
under the Act only the DEA would have the authority to decide
when prescribing controlled substances is for a legitimate
medical purpose. This is direct federal involvement in setting
standards of medical care. From a constitutional perspective,
direct control of the practice of medicine traditionally has
been left up to the states under their police powers.\8\ Even
the Controlled Substances Act requires the federal government
to take into account state law.\9\ But here, not only does the
proposed bill expand the DEA's authority to regulate the
practice of medicine, the bill explicitly requires the federal
government to ignore state law altogether. Again, in 1998 the
AMA strongly urged Congress to reconsider the wisdom of making
the DEA ``an arbiter of the practice of medicine.'' This bill
does just what the AMA cautioned against in 1998.
---------------------------------------------------------------------------
\6\ S. 1272, Section 101.
\7\ S. 1272, Section 101.
\8\ Linder v. United States, 268 U.S. 5, 18 (1924).
\9\ 21 U.S.C. Sec. 903 states:
No provision of this subchapter shall be construed as
indicating an intent on the part of Congress to occupy the
field in which that provision operates, including criminal
penalties, to the exclusion of any State law on the same
subject matter which would otherwise be within the
authority of the State, unless there is a positive conflict
between that provision of this subchapter and that State
---------------------------------------------------------------------------
law so that the two cannot consistently stand together.
While this provision does not prevent Congress from enacting new
legislation which would create a positive conflict with a state law,
even the factors considered in DEA registration are supposed to take
into account state law. For example, in registering physicians in order
to permit them to distribute controlled substances, consideration shall
be given to ``compliance with applicable State and local law,'' 21.
U.S.C. Sec. 823(b)(2) and (e)(2). This bill completely ignores state
law.
conclusion
Putting aside the moral and ethical considerations with
respect to Oregon's Death With Dignity Act and physician-
assisted suicide in general, the recent federal proposal to
legislate palliative care standards and give authority to
federal, state, and local law enforcement officials to monitor
and investigate the legitimate use of controlled substances in
pain management clearly puts the federal government in the
business of regulating the practice of medicine. Neither the
current language of the Controlled Substances Act nor the U.S.
Supreme Court support this role for the federal government.\10\
---------------------------------------------------------------------------
\10\ 21 U.S.C. Sec. 903; 21 U.S.C. Sec. 823; Linder v. United
States, 268 U.S. 5 (1924).
---------------------------------------------------------------------------
Please let us know if you have further questions or
concerns regarding the Pain Relief Promotion Act of 1999.
Sincerely,
Mark A. Bonanno.
____
University of Pittsburgh,
Pittsburgh, PA, April 24, 2000.
Re H.R. 2260, Pain Relief Promotion Act of 1999.
Senator Arlen Specter,
Hart Senate Office Building,
Washington, DC.
Dear Senator Specter: We, a group of bioethicists of differing
views about the moral issues arising in end-of-life situations, are
writing to you to express our common opposition to the Pain Relief
Promotion Act, H.R. 2260, hereinafter ``PRPA''. Our opposition rests on
several grounds, with particular emphasis on the ethical and moral
aspects of this bill. As bioethicists, we find it crucial to protect
and promote ethical behavior by physicians. Of course, we recognize
that the PRPA may be intended, in the view of some, to do just that by
prohibiting physicians from assisting in suicide--more specifically,
from prescribing federally controlled drugs for hastening the deaths of
terminally ill patients who request it, even where this has been made
legal--but this bill can be expected to have just the opposite effect.
It threatens to undermine the conditions for ethically acceptable
physician behavior in a much wider range of areas. It is a dangerous
bill, truly a wolf in the clothing of a sheep.
1. PRPA can be expected to put physicians in an impossible ethical
position. The physician must either abandon the patient to pain and
suffering, in the many situations in which these cannot be adequately
relieved, or risk federal investigation and imprisonment. Because the
conditions for determining intent on the part of the physician are open
to vagaries of judgment, physicians will be forced to take the most
cautious route, even when treating solely for pain. The prospect of 20
years in jail is not a risk many physicians will be willing to take,
even to ease the pain of patients to whom they are deeply dedicated and
for whom they have been caring over a long period of time. They will be
even less willing to do so for patients who are poor, who are members
of vulnerable groups, or are otherwise more distant from them.
2. The treatment of pain, whether at the end of life or at any
other time, involves sensitive medical decisions that should be made by
doctors and patients, not by legislators or regulators. The presence of
federal inspectors will have a predictable--and intolerable--dampening
effect on physicians' capacities for adequate pain control. This will
sabotage not only the very considerable recent progress in pain and
symptom control that has been made over the last several years, but
will render H.R. 2260 inconsistent on its face: it announces itself as
a ``pain relief promotion'' act, but will undercut the effective
delivery of pain relief.
The evidence for this claim is legion. Repeated studies document
that when physicians have reason to believe that their prescribing
practices will bring scrutiny, they are less likely to prescribe
appropriate medications. This has been demonstrated when the
scrutinizing parties are medical disciplinary boards, which have only
the power to limit or terminate a physician's license;\1\ the PRPA
would have an even more detrimental effect on appropriate prescribing
practices since the penalties are criminal and involve prison
sentences. Attention to adequate pain control has been one of the most
important gains in the end-of-life debates; this legislation would
reverse these gains.
---------------------------------------------------------------------------
\1\ ``Breaking Down the Barriers to Effective Pain Management,''
Recommendations to improve the Assessment and Treatment of Pain in New
York State, Report to the Commissioner of Health, January 1998 (70% of
New York physicians acknowledge declining to prescribe controlled
substances when indicated due to concern that prescribing would bring
scrutiny); Institute of Medicine, Approaching Death, Improving Care at
the End of Life, at p. 191, 197 (National Academy Press, 1997) (system
of oversight for prescribing controlled substances is burdensome and
deters legitimate prescribing of opioids to patients at the end of
life); David Joranson, State Medical Board Guidelines for Treatment of
Intractable Pain, American Pain Society Bulletin, vol. 5, no. 3 (May/
June 1995), at 2 (citing California study reflecting that physicians
avoid prescribing controlled substances for pain due to fear of
discipline by the medical board); Robyn S. Shapiro, Health Care
Providers' Liability Exposure for Inappropriate Pain Management, 24 J.
Law, Medicine & Ethics 360, 363 (Winter 1996) (identifying fear of
legal penalties, especially disciplinary action, as one of the most
important reasons health professionals undertreat pain. 69% of
California physicians acknowledge that the potential for disciplinary
action made them more conservative in their use of opioids in pain
management).
---------------------------------------------------------------------------
3. Doctors would be under the surveillance of the criminal justice
system, a system which has no expertise in the sensitive sorts of
decisions that must be made by a patient and his or her physician as
the patient is dying. Both physicians and patients resent what they
view as intrusions by government in this intimate professional
relationship.
4. H.R. 2260 will not eliminate physician-assisted suicide. Every
study that has been conducted in this country reveals its occurrence,
in every part of the country where such research has been undertaken,
underground and in completely uncontrolled conditions.\2\ The bill will
simply drive the practice further underground, into more disguised and
more unprotected conditions.
---------------------------------------------------------------------------
\2\ Emanuel EJ; Daniels ER; Fairclough DL; Clarridge BR. The
practice of euthanasia and physician-assisted suicide in the United
States: Adherence to proposed safeguards and effects on physicians.
JAMA 1998;280(6):507-13. Meier DE; Emmons CA; Wallenstein S; Quill T;
Morrison RS; Cassel CK. A national survey of physician-assisted suicide
and euthanasia in the United States. N Engl J Med 1998;338(17): 1193-
201.
---------------------------------------------------------------------------
5. The duplicity of the ``Pain Relief Promotion Act'' will--and
should--arouse substantial public opposition. Among its purposes,
acknowledges Senator Nickles in his written comments on the bill, is
the objective of rendering inoperable laws legalizing physician aid-in-
dying, such as that which was passed resoundingly by the citizens of
Oregon; it provides comparatively token attention to pain relief as a
cover for so doing.
The undersigned hold many different positions on Oregon's law and
other ``right-to-die'' legislation. But we are united in our alarm at
the dire consequences the passage of this legislation would have, both
for physicians and for their patients whose pain can be relieved only
with adequate prescribed controlled substances. There have been
important recent gains in pain control for the dying; we ask you not to
undercut them with this dangerous bill.
[We would appreciate your making this letter a part of the record
of the April 25, 2000 hearing on this bill. The views expressed by the
signatories to this letter are their own and not those of their
institutions, which are listed for identification purposes only.]
Sincerely,
Alan Meisel, J.D., Director, Center for Bioethics and Health Law,
and Dickie, McCamey & Chilote Professor, Bioethics and Professor of
Law, University of Pittsburgh.
Howard Degenholtz, Ph.D., Assistant Professor, Health Services
Administration, Center for Bioethics and Health Law, University of
Pittsburgh.
Lawrence A. Frolik, Professor of Law, University of Pittsburgh
School of Law.
David Barnard, Ph.D., Professor and Director of Palliative Care
Education, Center for Bioethics and Health Law, University of
Pittsburgh.
Lisa S. Parker, Ph.D., Associate Professor, Center for Bioethics
and Health Law and Department of Human Genetics, University of
Pittsburgh.
Bradley Lewis, Department of Psychiatry, Center for Medical Ethics,
Program for Cultural Studies, University of Pittsburgh.
Mark R. Wicclair, Ph.D., Professor of Philosophy and Adjunct
Professor of Community Medicine, West Virginia University, and Adjunct
Professor of Medicine and Instructor in the Bioethics Program,
University of Pittsburgh.
Bob Arnold, Section of Palliative Care and Medical Ethics,
University of Pittsburgh Medical School.
Glen McGee, Ph.D., Center for Bioethics, University of
Pennsylvania.
Ernle W.D. Young, Ph.D., Professor of Ethics, Stanford University
School of Medicine, and Co-Director, Stanford University Center for
Biomedical Ethics.
Ben A. Rich, J.D., Ph.D., Associate Professor, Bioethics Program,
University of California at Davis Medical Center.
Kathy L. Cerminara, Assistant Professor, Shepard Broad Law Center,
Nova Southeastern University.
Kenneth Kipnis, Ph.D., Professor of Philosophy, University of
Hawaii at Manoa.
Elaine Morgan, M.D., Associate Professor of Pediatrics, Hematology/
Oncology, Children's Memorial Hospital, Northwestern University.
David Orentlicher, M.D., J.D., Samuel R. Rosen Professor of Law,
Co-Director, Center for Law and Health, University School of Law-
Indianapolis.
Joan C. Callahan, Professor, Department of Philosophy, and
Director, Women's Studies Program, University of Kentucky.
Judith A. Erlen, Ph.D., RN, Professor, University of Pittsburgh,
School of Nursing.
Gregory Pence, Professor, School of Medicine and Department of
Philosophy, University of Alabama at Birmingham.
Dr. Erich H. Loewy, Professor and Endowed Alumni, Association Chair
of Bioethics, University of California at Davis.
James W. Walters, Ph.D., Ethicist, Loma Linda University.
Gerald Dworkin, Professor of Philosophy, University of California
at Davis.
Kenneth W. Goodman, Ph.D., Director, Bioethics Program, University
of Miami.
Timothy F. Murphy, Ph.D., Associate Professor, University of
Illinois College of Medicine at Chicago.
Joel Frader, M.D., Associate Professor of Pediatrics and Associate
Professor of Medical Indiana Ethics and Humanities, Northwestern
University Medical School, and Medical Director, Pediatric Palliative
and Hospice Care Program, Children's Memorial Hospital.
Charles W. Lidz, Ph.D., Research professor of Psychiatry,
University of Massachusetts Medical School.
Robert D. Truog, M.D., Professor of Anesthesia, Professor of
Medical Ethics, Harvard Medical School.
Yale Kamisar, Professor of Law, University of Michigan.
Jeffrey Kahn, Ph.D., M.P.H., Director, Center for Bioethics,
University of Minnesota.
Steve Miles, M.D., Professor of Medicine, Geriatrics, and
Bioethics, University of Minnesota.
Rebecca Dresser, J.D., Professor of Law and Ethics in Medicine,
Washington University Law School.
Rob Schwartz, Carl Hatch Professor of Law and Professor of
Pediatrics, University of New Mexico.
Bonnie Steinbock, Department of Philosophy, University of Albany,
State University of New York.
Maxwell J. Mehlman, Arthur E. Petersilge Professor of Law,
Director, The Law-Medicine Center, Case Western Reserve University
School of Law, and Professor of Biomedical Ethics, Case Western Reserve
University School of Medicine.
Norman Daniels, Department of Philosophy, Tufts University.
Adrienne Asch, Ph.D., M.S., Henry R. Luce Professor in Biology,
Ethics, and the Politics of Human Reproduction, Wellesley College.
Leonard M. Fleck, Ph.D., Professor of Philosophy and Medical
Ethics, Michigan State University.
David J. Mayo, Ph.D., Faculty Associate, Center for Bioethics,
University of Minnesota, and Professor, Department of Philosophy,
University of Minnesota--Duluth.
Norman L. Cantor, Professor of Law and Justice, Nathan Jacobs
Scholar, Rutgers Law School, Newark.
Samuel Gorovitz, Ph.D., Professor of Philosophy and Public
Administration, Syracuse University.
Rosamond Rhodes, Ph.D., Director, Bioethics Education, Mount Sinai
School of Medicine.
Professor R.G. Frey, Department of Philosophy, Bowling Green State
University.
Leslie Pickering Francis, Professor of Philosophy and Professor of
Law, University of Utah.
Dan W. Brock, Ph.D., Charles C. Tillinghast, Jr. University
Professor, Professor of Philosophy and Biomedical Ethics, Director,
Center for Biomedical Ethics, Brown University,
John D. Arras, Porterfield Professor of Bioethics, University of
Virginia.
Albert R. Jonsen, Ph.D., Professor of Law and Medical Ethics,
School of Medicine, University of Washington.
Margaret P. Battin, Ph.D., Distinguished Professor of Philosophy
and Adjunct Professor of Internal Medicine, University of Utah.
R. Alta Charo, J.D., Professor Emeritus of Ethics in Medicine,
University of Wisconsin Law School.
______
Oregon Hospice Association,
April 25, 2000.
Committee on the Judiciary,
U.S. Senate.
Chairman Hatch and Members of the Committee: I am submitting
testimony today on behalf of the Oregon Hospice Association (OHA),
which opposes the Pain Relief Promotion Act of 1999 (PRPA), and of the
Task Force to Improve Care of Terminally Ill Oregonians (ICTIO) and the
Physician Orders for Life Sustaining Treatment Task Force (POLST), both
of which have grave concerns.
OHA is a charitable, public benefit, not-for-profit membership
organization dedicated to ensuring that all Oregonians have access to
high quality hospice and comfort care. OHA is one of the few secular
organizations that opposed the Death With Dignity Act in 1994 and
supported its repeal in 1997. It no longer matters whether we think
physician-assisted suicide is right or wrong. It is the law here and we
support the right of dying Oregonians, including our patients, to
access all of their legal end-of-life options.
ICTIO and POLST task forces are made up of 26 and 22 individuals
respectively, representing public and professional organizations,
public and private medical centers, state boards, and governmental
agencies involved with health care. The task forces are neutral in
respect to physician-assisted suicide. Their statements of concern
about the PRPA and lists identifying members are attached. I represent
OHA on both.
We are uniquely qualified to speak to provisions within the PRPA.
Few Americans have given as much thought or have taken as much action
as we have, in our independent organizations and in the task forces,
towards both achieving excellence in end of life care and incorporating
physician-assisted suicide into the end of life care continuum.
Responsibly. Successfully. When we say that the Pain Relief Promotion
Act of 1999, with or without the Hatch Substitute Bill, will have a
chilling effect on the prescribing practices of physicians for pain and
symptom management, you should listen.
We can understand that you want to believe the PRPA will both stop
physician-assisted suicide in Oregon and improve pain and symptom
management at the end of life. But our experience will not allow us to
believe that a law that will (1) judge the intent of a physician and
(2) add more regulatory scrutiny to a problem caused by what is already
too much can fix the problems that have led to the epidemic of pain in
the United States. That just the prospect of federal action has had a
negative impact in Oregon supports our belief. Since late 1997, the
perceived risk of an investigation--and an investigation itself,
whether it leads to conviction or acquittal, can have a devastating
effect on a physician's livelihood--has been increased by, first, the
letter from Mr. Constantine of the DEA, when the law was finally
implemented. Immediately following Ms. Reno's decision that the DEA did
not have the authority to prosecute physicians for prescribing a lethal
prescription, the Lethal Drug Abuse Prevention Act of 1998 (LDAPA) was
introduced. When the LDAPA was abandoned, the threat continued with the
introduction of the PRPA in 1999. We've been able to measure the
impact.
Coincidentially, family members were interviewed about the deaths
of loved ones occurring throughout 1997, as part of an Oregon Health
Sciences University Ethics Center research project on end-of-life care.
During late 1997, when the Death With Dignity Act was implemented and
these threats began, the reported rate of moderate to severe pain and
suffering during the last week of life increased significantly in the
hospital setting. The reported rate of moderate to severe pain at home
or in nursing homes remained stable at approximately 30 percent
throughout the year, the same rate as was reported in hospitals for the
first nine or ten months.\1\ \2\ The ICTIO task force recently
previewed new data supporting these conclusions that will be released
in a report in May or June. It is my understanding that some of this
information will be made available to the Committee. I hope you will
take time to recognize its significance.
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\1\ Tolle S., Haley K. Pain management in the dying: successes and
concerns. Fall Issue of BME Newsletter, 1998.
\2\ The Oregon Report Card: Improving Care of the Dying. Center for
Ethics in Health Care. OHSU, 6/99.
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Of interest too, is the sharp downward turn of Oregon's morphine
consumption rate graphed early in 1998, which would reflect a decreased
usage of morphine late in 1997--and constitute further evidence of the
chilling impact on physician prescribing practices. This information is
also being made available to you.
As you are asked to consider data relative to pain and morphine
consumption--and the impact of PRPA--like state laws, you should be
aware of the following:
A rate of moderate to severe pain of 30 percent is
unacceptable in Oregon, or anywhere else. However, the lowest
reported pain in any previous study conducted in the United States
was 50 percent. A 1994 AHCPR report revealed that two-thirds of
cancer pain and half of all post-operative pain in the country was
undertreated.\3\ Unfortunately, there is little evidence that these
numbers have changed significantly in the past seven years.
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\3\ Management of Cancer Pain. Clinical Practice Guideline, Number
9. Agency for Health Care Policy and Research, March 1994.
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Oregon's rate of morphine use is consistently higher than the
national average, even when it has been ``depressed''. In 1998,
Oregon finished out the year in sixth place at 3,580 grams/100,000
population. Oregon was second in 1999, at 4,044, behind New
Hampshire at 4,200, although Oregon was first in the first three
quarters. The national average in 1998 was 2,400 grams; in 1999,
2,468. In 1996, the national average was half of that at 1,267
grams.
In April, 1998, Oregon was recognized as the national leader
in end of life care by the Robert Wood Johnson Foundation under
their State Initiatives in End-of-Life Care programs. Hospice
penetration in Oregon, the number of hospice deaths compared to
total deaths, is 32 percent, probably second highest in the nation
behind Arizona. Access to hospice in Oregon, even in rural and
remote areas of the state, is close to 100 percent. Although
hospices in Oregon do not turn away patients because of an
inability to pay, only 1 percent of hospice patients in Oregon are
uninsured or without resources.\4\ The hospital death rate is the
lowest in the country at 30 percent. The death rate at home and in
nursing homes is the highest at 31 percent each. Health care costs
in Oregon are the lowest in the country, although satisfaction
rates are high. Respect of health care wishes is very high, and
with the POLST form, at close to 100 percent.\5\ The SUPPORT study
of five medical centers throughout the country revealed no
correlation with what a patient said they wanted and with what they
got.\4\ \5\ \6\
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\4\ Using qualitative and quantitative data to shape policy change.
Focus: Oregon, State Initiatives in End-of-Life Care, Issue 1, June
1998.
\5\ Oregon Hospice Association data.
\6\ The SUPPORT Principal Investigators. Controlled trial to
improve the care of seriously-ill hospitalized patients. JAMA 1995;
274: 1591-1598.
The Oregon Hospice Association entered the public debate over
physician-assisted suicide to offer a moderate and objective voice to
the discussions, to help separate out the logical arguments from the
emotional. As a secular organization, OHA is not bound by religious
considerationsk, although ethical considerations are of importance. Our
goal was to educate, to do what we could to assure that it was a well-
informed Oregonian who voted in November. We did not want Oregonians to
believe that physician-assisted suicide was the best response to fears
of pain, of dying alone or in poverty, of being kept alive hooked up to
machines, or of losing their dignity.
The testimony you hear today will likely touch on all of those.
You will hear that proponents of physician-assisted suicide misled
Oregon voters by claiming that the Death with Dignity Act was needed to
prevent pain and suffering, but that those who have chosen physician-
assistedn suicide have not been in pain.
When I say that Oregon has implemented physician-assisted suicide
responsibly, I cite the fact that Oregonians are not choosing
physician-assisted suicide because of pain or any other symptoms we can
fix. The fear of pain was a major reason Oregonians voted for the Death
With Dignity Act and a major reason why they begin the process of
determining eligibility. But when they are getting the kind of care
they need, 46 percent of those who request a lethal prescription never
use it.\7\ Whether they need physician-assisted suicide or not, they
perceive that they may need it. ``A man who fears suffering is already
suffering is already suffering from what he fears.'' \8\
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\7\ Ganzini L., Nelson HD, Schmidt TA, Kraemer DF, DeLorit MA, Lee
MA. Physicians' experiences with the Oregon Death With Dignity Act, N
Engl J Med 2000; 342:557-63.
\8\ Essayist Michel de Mantagne.
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That Oregonians voted for physician-assisted suicide even when they
were assured that all physical and emotional pain at the end of life
can be treated reflects a level of trust that will further be
compromised if the PRPA is passed. Making physician-assisted suicide
illegal is not the only way to discourage it. Congress would be far
more constructive if it eradicated the barriers it's erected that
compromise access to hospice and palliative care, to home health care,
and to medication. What good is a prescription for pain medication, if
the patient can't afford to fill it?
You will hear testimony that physician-assisted suicide devalues
the disabled, the sick, the elderly, and the poor, Conferring value on
these populations is an admirable--and achievable--goal, but not one
Congress can do by passing the PRPA. Physician-assisted suicide is a
response to the fears of losing independence, of being unable to get
needed care or medicine, of outliving resources, or of impoverishing
families. These are the problems we've been unable to fix in Oregon, as
health care professionals, and these are the reasons most Oregonians
have given for choosing physician-assisted suicide. These reasons will
remain whether or not physician-assisted suicide is allowed in Oregon
or any where in America. Congress can fix those problems, if it has the
courage to redistribute some of the enormous wealth that only some of
the country enjoys.
You will hear testimony that, contrary to our claims that the PRPA
will have a negative impact on pain management, pain management has
improved in those states who have already passed PRPA-like laws.
Louisiana has been cited as an example. In 1996, morphine consumption
in Louisiana was less than 1,621 grams per 100,000 population. In 1998,
Louisiana was ranked 41st in the nation at 1,973 grams. In 1999,
Louisiana dropped to 42nd place at 1,890 grams. Kansas was 39th in 1998
at 2,016, and went up slightly to 32nd in 1999 at 2,179. Rhode Island
was 24th in 1998 at 2,480 and 40th in 1999 at 2,018. Rhode Island's
consumption rate in 1996 was less than 972 grams. Virginia was 33rd in
1998 at 2,106 and 27th in 1999 at 2,401, a very modest gain.
Texas has been cited as an example of a state that was not harmed
by PRPA-like legislation. But if morphine consumption is even a crude
indicator, PRPA-like legislation cannot overcome the barriers created
by restrictive state multiple copy monitoring laws. In 1999, at 1,834
grams, Texas remained at 45th in the nation, in 1998 they were at 1,844
grams. None of the six or seven states with such ``hassle'' laws has
risen above average in morphine consumption. New York, which has
recently switched to electronic monitoring is 39th at 2,044; Texas is
45th; Idaho is 47th at 1,761; Illinois is 48th at 1,663, (up from 51st
in 1998); and Hawaii is 51st at 1,607.
It's interesting to look at morphine consumption, too, from another
perspective. Oklahoma is ranked 30th in 1999 and 34th 1998 at 2,137 and
2,186, respectively. Utah is 44th at 1,840, up from 48th in 1998,
although Utah's large population of children can at least partially
explain the low rate. Senator Nickles and Senator Hatch and Congressman
Hyde have reason to be worried about pain management in their states.
The PRPA, however, is not likely to have the impact they'd like. Ohio,
incidentally, is ranked 41st in 1999, at 1,980, down from 37th in 1998.
Morphine consumption rates have been increasing significantly
throughout the country. The question is, what rate should we be aiming
for? Is Oregon's rate at over 4,000 grams per 100,000 population high
enough? No, it's not if 30 percent of Oregonians, or more, experience
pain in their last week of life. If Oregon's rate is even close to high
enough, it still means that nearly every other state needs to increase
their rate by 50% or 100% or 400%.
Restrictive state prescribing laws and harsh state medical board
policies have already created unnecessary barriers to adequate pain
management. It's time to abolish the kinds of laws and regulations that
perpetuate the myth that controlled substances are unusually dangerous
drugs, not to create more. ``Just say no!'' isn't always the right
answer.
By trying to draw an arbitrary line between what is killing the
patient and what is killing the pain, and by basing that line on
something as ephemeral as a doctor's intent, the PRPA will create
another barrier--an incentive and another excuse for a physician to
under prescribe controlled substances. When erring on the side of
caution reduces his or her risk of an investigation to virtually zero,
it will be the patient that will lose.
We haven't talked much about what kind of impact the PRPA, if
passed, might have on the public.
In fact, the patient, and their family, is unlikely to win. On one
side, the patient and their family will experience unnecessary pain,
but because most people believe that death is of necessity a painful
experience, they'll be unlikely to report a physician for under
prescribing. On the other side, the patient and their family will more
likely experience an invasion into their grief, if a pharmacist, a
nurse, a family member, or a neighbor, triggers an investigation
because he or she is alarmed at the amount of drugs prescribed or
suspicious about a death that follows soon on the heels of a
prescription. Death investigations, no matter how sensitive, are
painful experiences for a bereaved family. We've had that experience
here in Oregon, too.
While I've testified as a health care professional, I am well
qualified, too, to testify from a personal perspective. I have had
multiple sclerosis (MS) since I was a teenager. I am able to work now,
almost without restriction, thank God, but there have been times in my
life when I was unable to see or unable to walk. I was my fiance's
caregiver in 1996, when he died in California. Until he was admitted to
hospice, I was the one who navigated California's restrictive
prescribing laws, obliterating the artificial barriers he encountered
in getting his pain managed. Had I not been there as an advocate, with
my knowledge about pain and symptom management, the course of his
illness would have been very different. And I am an ``older'' American,
who is assuming more and more responsibility for my elderly mother and
sister and brother-in-law, who are both disabled. My mother's pride and
her need for independence have kept her from asking for--or accepting--
help. I thought she was being penny-wise and pound foolish when she
took only half of her pain medication! The fact is that old age and
disability have severely depleted her resources. She can no longer
afford, on her own, to get her prescriptions filled!
Twenty years from now, when I'm in her boat, I'll look back on this
time as if it were yesterday.
Respectfully submitted,
Ann Jackson, Executive Director/CEO,
Oregon Hospice Association.
______
Physician Orders for Life-Sustaining Treatment Task Force
concerns regarding unintended consequences of the pain relief promotion
act (hyde/nickles bill)
Since 1991, the Physician Orders for Life-Sustaining Treatment
(POLST) Task Force has endeavored to help health care providers honor
patient wishes for life-sustaining treatments. The group, comprised of
22 individuals representing 14 heath care organizations, has developed
and helped implement the POLST document in health care organizations
and communities ensuring respect for patient preferences at the end of
life. The document includes orders regarding CPR, other services
provided by emergency medical services, antibiotics, and use of
artificial fluids and nutrition. The Task Force has made special
efforts to assure that comfort measures are always provided when life-
support is withheld or withdrawn. The program has been promoted by the
Institute of Medicine, The Robert Wood Johnson Foundation's State
Initiatives in End-of-Life Care, and is included in the Education for
Physicians on End-of-Life Care program of the AMA. Although the
successful POLST project is specific to Oregon, other states are
developing similar programs.
The POLST Task Force has no position on Oregon's Death With Dignity
Act and has concerns regarding the Pain Relief Promotion Act proposed
by Senator Nickles. The Task Force feels that the threat of
investigation or disciplinary action, whether real or perceived, will
lead some physicians to prescribe less medication thereby causing more
pain and suffering for their dying patients.
polst task force--april 2000
Name and organization
Jerry Andrews, EMT-P, EMS/Multnomah Co. Health Department
Mark Bonnano, JD, Oregon Health Decisions
Ken Brummel-Smith, MD, Long Term Care Div./Providence Health Sys.
Margaret Carley, JD, Oregon Health Care Association
Patrick Dunn, MD, FACP, OHSU/Center for Ethics in Health Care
Dan Field, Oregon Assoc. of Hospitals & Health Sys.
Sally Goodwin, MM, Oregon Alliance of Senior & Health Services
Tim Hennigan, AS, EMT-P, EMS/Multnomah Co. Health Department
Ann Jackson, MM, Oregon Hospice Association
Susan King, RN, MS, Oregon Nurses Association
Mimi Luther
Dan McFarling, Nursing Facilities/SDSD
Chris Nelson, RN, MS, OHSU School of Nursing
Holly Robinson, JD, Legal Services/SDSD
Trudy Schidleman, RN, (prior Assoc. Director, EMS Services)
Terri Schmidt, MD, OHSU Emergency Services
Carmen Spencer, RN, BSN, CBCQI/SDSD
Virginia Tilden, RN, DNSc, OHSU Center for Ethics in Health Care
Susan Tolle, MD, OHSU Center for Ethics in Health Care
Molly Weinstein, JD
______
June 17, 1999.
In January of 1995, the Center for Ethics in Health Care at the
Oregon Health Sciences University convened the Task Force to Improve
the Care of Terminally Ill Oregonians. The Task Force is a consortium
of health professionals, organizations, agencies and institutions which
seek to promote excellent care of the dying and to address the ethical
and clinical issues posed by the enactment of the Death With Dignity
Act. While individual Task Force members and the organizations they
represent have differing views and values regarding physician assisted
suicide and the Death With Dignity Act, the Task Force has endeavored
to maintain a neutral position on these issues. The Task Force is
comprised of 24 agencies and organizations, all of whom support the
goals of quality pain management and promoting excellence in care of
the dying. A list of Task Force members, member organizations is
attached.
``The Task Force to Improve the Care of Terminally Ill Oregonians
is concerned that the Nickles Bill will have a negative impact on pain
and symptom management at end of life.''
task force to improve the care of terminally-ill oregonians--june 1999
Name and organization
Frank J. Baumeister, Jr., MD, Oregon Medical Association
Joan Bouchard, RN, Oregon State Board of Nursing
Margaret Carley, JD, RN, Oregon Health Care Association
Patrick M. Dunn, MD, Oregon Health Sciences University
Tony Farrenkopf, PhD, Oregon Psychological Association
Dan Field, JD, Oregon Assoc. of Hospitals & Health Systems
Linda Ganzini, MD, Oregon Psychiatric Association
Lyn Glenn, RN, BSN, OCN, Oncology Nursing Society
Kelly T. Hagen, JD, Health Law Section, Oregon State Bar
Kathleen Haley, JD, Director, Board of Medical Examiners
Katrina Hedberg, MD, Oregon Health Division
Susan Hedlund, LCSW, National Assoc. of Oncology Social Workers
Ann Jackson, MM, Oregon Hospice Association
Teresa Kraemer, RN, JD, Oregon Alliance of Senior & Health Services
Pam Matthews, RN, BSN, CHCE, Oregon Association for Home Care
Sherry Moore, RN, Oregon Nurses Association
Bonnie Reagan, MD, RN, Adventist Medical Center
Robert Richardson, MD, Kaiser Permanente Ethics Service
Terri Schmidt, MD, MS, Tri-County EMS Physician Supervisors Group
Gary Schnabel, RN, RPh, Oregon State Pharmacists Association
Joseph Schnabel, Pharm.D., Board of Pharmacy
Martin Skinner, MD, Oregon Medical Association
Susan W. Tolle, MD, Director, Center for Ethics in Health Care
Fr. John Tuohey, Providence St. Vincent Health System
The Chairman. Senator Smith.
STATEMENT OF HON. GORDON SMITH, A U.S. SENATOR FROM THE STATE
OF OREGON
Senator Smith. Thank you, Mr. Chairman, members of the
committee. I thank you for granting my request and that of my
colleague, Ron Wyden, to hold this hearing today. There are
good people on both sides of this very controversial and
emotional issue of assisted suicide, but I think given the
importance of the issue, we can all be united in the belief
that it deserves the full and fair hearing and process every
step of the way.
Mr. Chairman, this is a difficult day for me, but I am glad
I am seated with my colleague, Ron Wyden. It is a matter of
Senate history that he and I fought a very difficult campaign
against one another, but ultimately we became colleagues, but
more, we have become friends, and my pledge to him is that that
will continue on my part, even while we differ on the ultimate
vote in this case.
Mr. Chairman, I am going to read my statement and ask that
it also be included as part of the permanent record.
The Chairman. Without objection, it will be.
Senator Smith. I do this in order that I might get through
this in a way intelligible to you.
The debate over physician-assisted suicide is a relatively
new one in the halls of Congress and throughout most of the
country, but this is not the case in my State of Oregon.
Indeed, Oregon's debate began in earnest at about the same time
I began my public service as an Oregon State Senator in 1993.
In 1994, 51 percent of Oregon voters approved an initiative
allowing physician-assisted suicide, and in 1997, 60 percent of
Oregon voters chose not to repeal that decision.
The first initiative made the matter of assisted suicide a
central concern to voters in my two campaigns for election to
the U.S. Senate in 1996, and the second initiative vote has
made it a central concern to Oregonians throughout my years of
service in this body.
It is no exaggeration to say that my views on the subject
were sought at every campaign stop prior to my election and
have been sought at every town hall since my election. On
hundreds upon hundreds of occasions, my answer was always and
is always without variance. I am opposed to physician-assisted
suicide.
Today, I come before this committee to repeat that answer
once again. Mr. Chairman, I am acutely aware that this position
places me at odds with the majority of my constituents and I
tell you that it is a lot more comfortable to be with the
majority in the business of democracy. For that reason, I admit
to having wrestled for a different conclusion in this issue in
order that I might once again take comfort in the crowd. But on
a matter of this magnitude, a matter of life and death, I have
failed to find comfort with a troubled conscience. But more, I
am loathe to let down the hundreds of thousands of Oregonians
who, though a minority, heard my answers and now count on the
integrity of my words.
And so, Mr. Chairman, recognizing that this places me in
conflict with a majority of my constituents but at peace with
my conscience, I am here today to urge the passage of the Pain
Relief Promotion Act. I am also here today to say that while on
this issue I cannot give Oregon's majority my vote, I owe them
an explanation.
Prior to my service in elected office, I served on a
volunteer basis as a bishop of the Church of Jesus Christ of
Latter-Day Saints in my hometown. In this capacity, I found my
professional work as a food processor in a constant but blessed
state of interruption. On a weekly basis and at the oddest of
hours, I found myself making continual rounds at St. Anthony's
Hospital in Pendelton, OR. On many occasions, I shared with
parents the unspeakable joy of welcoming newborn babies into
this world. On other occasions, I suffered heartbreaking
sorrows as I tried to comfort the critically ill or hold the
hands of those who lay at the brink of eternity.
In my life, I have never dealt with an issue that fills me
with more joy, more sorrow, and more reverence than does the
sanctity of life. Through my experiences at that hospital, I
came to believe as never before that men and women are not just
advanced animals but are children of divine origin and are here
on earth to have all of life's experiences, good and bad,
pleasure and pain, health and sickness.
I further believe that there is a natural course to living
and dying, and that with some exceptions, we should not shorten
life or lengthen life by artificial or invasive means. That is
a belief instilled in me during many hours that I spent on one
occasion with a dying woman. She had effectively died hours
before, but because of invasive high technology that provided
artificial respiration, nutrition, and hydration, and because
of physician fear over liability, her death, not her life, was
prolonged for many hours.
It is precisely because of these beliefs and my experiences
that I did the unexpected when I became an Oregon State
Senator. To the chagrin of a few in the pro-life community, I
coauthored one of the most liberal advanced directive laws in
the United States. Because of the role that I played,
Oregonians now have the right to refuse artificial respiration,
nutrition, and hydration in terminal circumstances. Moreover,
physicians can honor these requests secure in the protection of
law.
I viewed then and still view the withholding of
extraordinary medical measures as an act of omission, an
appropriate acquiesence to the timetable of nature's God. But I
stated then and believe still that physician-assisted suicide
is an act of commission, a step over the line, a step in which
the State should never have complicity. It is the line of
commission rather than omission that I cannot cross. I believe
the United States should never cross the line, either, by
allowing federally controlled substances to be used in
physician-assisted suicide. To do so would be bad policy and it
would have consequences over time unimaginable now. But what
are these consequences?
An Oregonian by the name of Derrick Humphries makes this
clear. He is one of the most vocal and visible advocates of
assisted suicide and he has written a book in 1998 called The
Freedom To Die. In the final chapter of Mr. Humphries' book, it
is entitled, ``The Unspoken Argument.'' Why is it unspoken?
Because it is so awful.
Let me quote from page 313 of Mr. Humphries' book, where he
reveals the true reason why he believes assisted suicide's time
has come. ``One must look at the realities of increasing costs
of health care in an aging society, because in the final
analysis, economics, not the quest for broadened individual
liberties or increased autonomy will drive assisted suicide to
the plateau of acceptable practice.'' Then he asks this
chilling question. ``Is there, in fact, a duty to die, a
responsibility within the family unit that should remain
voluntary but expected nevertheless?''
Mr. Humphrey answers yes, but I believe we must answer his
vision of Orwellian ugliness with a resounding no. I will not
be party to building such a society or justifying such a
culture of death. In such a culture, we should never wonder why
children do not value life when adults write laws that do not
value it, either.
The right to kill one's self is a private right. It is a
right that can be exercised in nearly everyone's medicine
cabinet. But it is dangerous to make doctors and the State
complicit in killing, even though consensual. In an age of
medical rationing and for-profit HMO's, there is a terrible
ethical and financial conflict of interest, and the Federal
Government should see it and stay away from it. Where Mr.
Humphries sees a duty to die, I see a duty to resolve the
shortcomings of our medical budgets rationally and honestly
without sacrificing the most vulnerable of our society, the
elderly and the disabled, to some newfangled duty to die.
Now, finally, Mr. Chairman, let me turn to the issue of
States' rights. At the heart of Oregon's twice-passed
physician-assisted suicide law is the assumption that Oregon
can change, expand, or interpret a 30-year-old Federal statute
in ways never authorized or contemplated by the national
government. Not since Lee's army surrendered to Grant at
Appomattox Court House has any State enjoyed such a right. The
Controlled Substance Act was passed expressly to control deadly
drugs in interstate commerce to ensure ``public health and
safety.'' It was the toxic and lethal nature of these drugs
that caused Congress to act, to limit and regulate their use to
``legitimate medical purposes.''
For a State, even my beloved State of Oregon, to
unilaterally act to use Federal drugs for lethal purposes is an
open invitation to the nation to reclaim and reassert its law.
Oregon has no more right to write Federal law than the Federal
Government has to write Oregon law.
Mr. Chairman, I do not know if I will ever have to cast my
vote on the Pain Relief Promotion Act, but if I do, Oregonians
know that I will answer aye. I would not do so had the bill's
sponsors not honored my request to include two important
provisions which had not been included in earlier drafts,
first, a provision to protect those doctors who may already
have aided in the death of a patient, acting in good faith and
within their understanding of Oregon's law, and second, a
provision that provides physicians with the protection of law
so that they may aggressively relieve pain.
With the inclusion of these provisions, I believe the Pain
Relief Promotion Act will free up physicians to relieve pain
and suffering as never before, with the right to use federally
controlled substances in massive amounts even if death is
thereby hastened.
Mr. Chairman, this weekend, I will return to Oregon and
begin again the process of discussing this issue and my
position with those citizens who have granted me the high
privilege of serving my native State in the United States
Senate. I deeply respect the fact that I do answer to them. I
will share with them words that have given me courage
throughout my years of public service, but most especially
during this past weekend in drafting this statement.
The words are these. ``Democracy means much more than
popular government and majority rule,'' wrote John F. Kennedy.
``The true democracy, living and growing and inspiring, puts
its faith in people, faith that the people will not simply
elect men who will represent their views ably and faithfully,
but also elect men who will exercise their conscientious
judgment, faith that the people will not condemn those whose
devotion to principle leads them to unpopular courses but will
reward courage, respect honor, and ultimately recognize
right.'' Thank you, Mr. Chairman.
The Chairman. I want to thank both of you. They are both
very good statements from two very highly respected Senators,
both representing your State in the best way you can. This is a
difficult set of issues and we are going to have to work our
way through them. But I want to thank you both for being here,
and Senator Nickels, as well, who had to leave early. Thanks so
much.
Our panel number two will consist of Eric Chevlen, M.D. He
is the Director of Palliative Care in the Cancer Care Center of
St. Elizabeth Medical Center in Youngstown, OH. Dr. Chevlen
supports the Nickles legislation and actually wrote a letter to
the editor in the Journal of American Medicine in favor of the
bill.
Arthur Caplan, Ph.D., he is with the Center for Bioethics
for the University of Pennsylvania Health System in
Philadelphia. Dr. Caplan is one of the minority witnesses and
he opposes the Nickles bill because he believes that the
legislation could hinder doctors from aggressively treating
pain.
Rabbi J. David Bleich is a professor at the Benjamin
Cardozo School of Law and a professor of law and ethics at
Yeshiva University. He is testifying on behalf of the Union of
Orthodox Jewish Congregations of America and he is strongly in
favor of the Nickles legislation.
Kathleen Foley, M.D., works for the Memorial Sloan-
Kettering Cancer Center and is strongly opposed to the Nickles
legislation. She is a devout Catholic. However, she believes
that this legislation will send the wrong message to drug
regulators, physicians, and patients about the medical use of
controlled substances. She believes that the bill provides
inadequate funding for pain care management training and
education and that it does not take into account any of the
Institute of Medicine of the National Academy of Sciences
recommendations on how to improve end-life care.
Walter Hunter is the Associate Medical Director for the
VistaCare Hospice in Indianapolis. He, too, is a strong
supporter of the Nickles legislation and Dr. Hunter testified
at the House hearing on this bill last year.
We will turn the time over to you first, Dr. Chevlen, and
go across the table.
STATEMENTS OF ERIC CHEVLEN, M.D., DIRECTOR OF PALLIATIVE CARE,
CANCER CARE CENTER, ST. ELIZABETH HOSPITAL, YOUNGSTOWN, OH;
ARTHUR L. CAPLAN, DIRECTOR, CENTER FOR BIOETHICS, AND TRUSTEE
PROFESSOR, UNIVERSITY OF PENNSYLVANIA, PHILADELPHIA, PA; RABBI
J. DAVID BLEICH, ON BEHALF OF THE UNION OF ORTHODOX JEWISH
CONGREGATIONS OF AMERICA, WASHINGTON, DC; KATHLEEN FOLEY, M.D.,
ATTENDING NEUROLOGIST, MEMORIAL SLOAN-KETTERING CANCER CENTER,
NY, NEW YORK; AND WALTER R. HUNGER, M.D., ASSOCIATE NATIONAL
MEDICAL DIRECTOR, VISTACARE HOSPICE, INDIANAPOLIS, IN
STATEMENT OF ERIC CHEVLEN
Dr. Chevlen. Thank you. Mr. Chairman, members of the Senate
Judiciary Committee, thank you for inviting me to address you
this morning to explain why the Pain Relief Promotion Act
should be adopted as law.
Allow me to introduce myself and explain my interest in
this bill. My name is Eric Chevlen. I am a physician practicing
in Youngstown, OH. My specialties are medical oncology and pain
medicine, and I also serve as medical director for two
hospices. I am certified by the American Boards of Medical
Oncology, Pain Medicine, and Hospice and Palliative Medicine.
Every day in my practice, I face the challenge of relieving
the suffering of my patients. One of my best tools in this
humane task is the class of drugs we physicians call opioids
and which this legislation refers to as narcotics. I prescribe
them without hesitation to patients for whom they are the best
analgesic. I prescribe them in doses that best balance side
effects and benefits no matter what the number of milligrams
may be. Given the nature of my practice, it is not a surprise
that I am one of the largest prescribers of opioids in Ohio. To
borrow a phrase from the world of business, I am the end user
of this proposed legislation.
There is one other thing you ought to know about me,
Senators. I am opposed to legalized euthanasia and physician-
assisted suicide. The reason is this. In over 20 years of
practicing medicine, more than a few of my patients have asked
me to kill them. In every case, every case, the request stemmed
from depression or anguish or desperation or fear of
abandonment.
In other words, my terminally ill patients sought
euthanasia or assisted suicide for the same reasons that
healthy people seek them, and as in the case of healthy people,
their suffering could be palliated and their longing for death
quelled by proper use of medicine, loving kindness, and what
some have called the ministry of presence. The answer to
anguish and desperation is not to coldly dispatch the anguished
and the desperate, but rather to enfold them within the bonds
of the community that sees them intrinsic rather than merely
utilitarian value.
I am opposed to euthanasia and I favor the passage of the
PRPA because it ends Federal collusion in the nasty business of
doctors killing their patients. Nevertheless, Senators, if the
PRPA were somehow to diminish the capability of physicians to
relieve the suffering of the dying, if it were to increase the
risk of harassment by over-weening bureaucrats, or even if it
were to chill the ardor of physicians to relieve suffering
because they misunderstood the bill, if any of these were the
case, then I would not be here speaking in support of the bill.
Indeed, I would likely be here speaking against it.
Such, however, is not the case. The PRPA would not diminish
the ability of doctors to relieve suffering of the dying or
others in pain. It is likely, frankly, that it would improve
their ability to do so.
Now, opponents of the PRPA argue that its language will
have a chilling effect on the willingness of doctors to
prescribe adequate doses of opioids to relieve the pain of
dying patients, that they will fear a meddlesome DEA
bureaucracy eager to swoop down on them and throw them in jail
for 20 years when poor grandma dies of cancer after her final
comforting doses of morphine.
Senators, the law today, as it has been for 30 years, is
that a controlled substance may not be used intentionally to
kill a patient. The PRPA does not create a new limitation on
use of opioids to relieve pain. Quite the contrary. This bill
puts into statute what has heretofore been only administrative
guideline, namely that it is legitimate medical purpose to use
a controlled substance to relieve pain even if that use
increases the risk of death. By the way, it does not.
This doctrine of double effect will remain the law in 49
States whether the PRPA passes or not. Making it explicit by
statute should increase, not decrease, physicians' comfort in
prescribing the opioids. In fact, this increase in morphine use
and other opioid use was seen in six States which adopted laws
similar to the PRPA, and that is shown on some of the posters
which are available at the sides of the chamber, and perhaps an
aide can put them up. I request that those be entered into the
record, Mr. Chairman.
The Chairman. Without objection.
[The information of Dr. Chevlen is attached to his prepared
statement.]
Dr. Chevlen. The increased reassurance concerning over-
weening regulation that physicians crave will not come from
defeating the PRPA but rather from passing it. This bill, for
the first time, calls for Federal dollars to be spent in the
training and education of both Federal and local officials so
that they will be more knowledgeable about proper palliative
care and less likely to mistake good care for a violation of
the law. If the PRPA is not passed, then there is nothing to
improve the situation as it now stands, nothing to reduce the
regulatory fear that inhibits doctors from prescribing drugs
properly.
Gentlemen, when I first earned my Federal license to
prescribe controlled substances, I was proud that my country
had recognized my competence to relieve the suffering of my
fellow citizens and had entrusted to me the privilege to
prescribe these medications for their benefit. It is deeply
offensive to contemplate how this license of which I was so
proud, a license to palliate the misery of my patients and
fellow creatures, this license has been degraded now to be a
Federal license to kill them, State law permitting--to kill
them, State law permitting.
Senators, remove this stain, erase this lot. Vote to
improve pain treatment and to protect the vulnerable citizens
of this country. Vote to allow honest physicians to relieve
pain without the stigma of a Federal license to kill. Please
pass the Pain Relief Promotion Act.
The Chairman. Thank you so much.
[The prepared statement of Dr. Chevlen follows:]
Prepared Statement of Eric Chevlen, M.D.
Mr. Chairman, members of the Senate Judiciary Committee: Thank you
for inviting me to address you this morning to explain why the Pain
Relief Promotion Act (PRPA) should be adopted as law.
introduction
Allow me to introduce myself and explain my interest in this bill.
My name is Eric Chevlen, M.D. I am a physician practicing in
Youngstown, Ohio. I am the director of palliative care at St. Elizabeth
Hospital, and medical director of two hospices. I am certified by the
American Board of Medical Oncology, the American Board of Pain
Medicine, and the American Board of Hospice and Palliative Medicine.
Every day in my practice I face the challenge of relieving the
suffering of my patients. One of my best tools in this humane task is
the class of drugs we physicians call opioids, and which this
legislation refers to as narcotics. I unhesitatingly prescribe them to
patients for whom they are the best analgesic, in doses that best
balance side effects and benefit, no matter what the number of
milligrams may be. Given the nature of my practice, it is not a
surprise that I am one of the largest prescribers of opioids in Ohio.
To borrow a phrase from the world of business, I am the ``end-user'' of
this proposed legislation.
There is one other thing you ought to know about me. I am opposed
to legalized euthanasia and physician assisted-suicide. The reason is
this: In over twenty years of practicing medicine, more than a few of
my patients have asked me to kill them. In every case--every case!--the
request stemmed from depression, or anguish, or desperation, or fear of
abandonment. In other words, my terminally ill patients sought
euthanasia or assisted suicide for the same reasons that healthy people
seek it. And, as in the case of healthy people, their suffering could
be palliated, and their longing for death quelled, by proper use of
medicine, loving kindness, and what some have called the ministry of
presence. The answer to anguish and desperation is not to coldly
dispatch the anguished and desperate, but rather to enfold them within
the bonds of a community that sees in them intrinsic, rather than
merely utilitarian, value.
I am opposed to euthanasia. Nonetheless, Senators, if the PRPA were
somehow to diminish the capability of physicians to relieve the
suffering of the dying, if it were to increase the risk of harassment
by overweening bureaucrats, or even if it were to chill the ardor of
physicians to relieve suffering because they misunderstood the bill--if
any of these were the case, then I would not be here speaking in
support of the bill. Indeed, I would likely be here speaking against
it.
Such, however, is not the case. The PRPA would not diminish the
ability of doctors to relieve the suffering of the dying or others in
pain. It is likely, frankly, that it would improve their ability to do
so.
history of the controversy
For some thirty years, the Controlled Substances Act (CSA) has
regulated the therapeutic use of opioids and other substances. For
thirty years, the federal law has recognized that, if misused,
controlled substances present a significant potential harm to the
public. For thirty years the law has also recognized that, when used
properly, they also offer a unique and wonderful relief of suffering.
To minimize the potential harm and to maximize the potential
benefit of controlled substances, Congress mandated that they be
prescribed only by practitioners who were licensed by the Drug
Enforcement Agency. Congress also demanded--and who could argue with
this?--that the prescribing of the controlled substances be done only
for legitimate medical purposes.
``Legitimate medical purposes.'' That is a phrase you will hear
often today, and whose interpretation--and misinterpretation--is the
crux of the issue before us today.
Until quite recently, there was never any argument over the meaning
of the term. Every doctor knew that he could not simply sell
prescriptions for cash. Every doctor knew that he could not swap
prescriptions for sexual favors. Every doctor knew that he could not
use prescribed drugs to commit homicide, even if the victim consented
or participated in that act.
There was never any question about all this. The meaning of the law
was plain, and it was buttressed by numerous uncontroversial court
decisions.
This clarity and integrity of the federal law came to an end,
however, after the passage of Oregon's notorious physician-assisted
suicide law. The question arose: if an Oregon practitioner is in
compliance with the admittedly loose requirements of that state law,
may he prescribe a controlled substance to kill his patient? The head
of the DEA said no: a state law cannot change the fact recognized by
federal law, that killing people is simply not a legitimate medical
purpose. The Attorney General overruled him. She said, in effect, that
in forty-nine states, killing patients was not a legitimate medical
purpose, punishable under the Controlled Substances Act. In Oregon,
however, it was to be considered a legitimate medical purpose--unless
the practitioner failed to fill out the requisite state paperwork.
Then, it would again be deemed not legitimate.
usurping congressional authority
Although that decision certainly generated a lot of discussion, I
am surprised at how little has been said concerning what a sweeping
Executive branch usurpation of Congressional authority was thereby
accomplished. The Attorney General's decision effectively eliminated
the Controlled Substances Act. If the impact of the law is to be
determined, as she says, by state standards, then there is in effect no
longer any enforceable federal standard. Oregon has now empowered its
physicians to prescribe lethal doses of controlled substances, and the
Attorney General says that if the state permits it, so too does the
federal government. In effect, she has created a federal license to
kill, if only state law be permitting. There is nothing in her ruling
that prevents other states from allowing physicians--or pharmacists or
podiatrists for that matter--from prescribing a panoply of controlled
substances according to any criteria that state may choose. According
to the Attorney General's Alice-in-Wonderland ruling, the federal
government must recognize the ``legitimate medical purpose'' of this,
simply because such action would be compliant with that state's law.
This point has been argued, and will surely be argued again if the
PRPA does not become law. In 1996, two years before the Attorney
General's decision in this case, California passed a law considerably
liberalizing the use and distribution of marijuana. In that case, the
Justice Department argued the opposite of its point in the Oregon
matter, saying, ``A state initiative cannot supplant the will of the
people of the United States.'' \1\ Later, however, in the Oregon
matter, the Attorney General argued that Congress never intended the
Controlled Substances Act to apply to such a duly passed state law.
Rather, claimed the Attorney General, Congress intended the scope of
the CSA to be somewhat limited, and authorized the DEA to prevent the
``particular drug abuse'' deriving from a drug's ``stimulant,
depressant, or hallucinogenic effect on the central nervous system.''
\2\
---------------------------------------------------------------------------
\1\ Justice Department attorney Mark Quinlivan, arguing before U.S.
District Court Judge Charles Breyer, quoted by Reuters newservice,
March 25, 1998.
\2\ Attorney General Janet Reno, Letter to Congressman Henry Hyde,
June 5, 1998.
---------------------------------------------------------------------------
Set aside, for a moment, the fact that her theory of the law is
completely unsupported by its legislative history, wording, and case
law interpretation. Even if one grants the Attorney General's theory,
that only drug abuse of this class is interdicted by the CSA, then use
of controlled substances to cause death is surely forbidden by the CSA.
After all, the very mechanism by which controlled substances in
overdose cause death is by depressing the central nervous system, in
particular the respiratory center.
Is there to be a uniform federal standard of ``legitimate medical
purpose'' or is there not? If the Senate feels there should not be any
standard meaning to a federal law, if it feels that the CSA should be
eradicated by bureaucratic legerdemain, then it should not pass the
Pain Relief Promotion Act. If, on the other hand, it feels as I do that
the very purpose of federal law is to protect the common good by
establishing clear and uniform application of the law, then it very
much should pass the PRPA. This act has as its main purpose the
restoration of a uniform national standard in the Controlled Substances
Act, but in fact it would do more: it would prevent the effective
elimination of the CSA by the Executive branch without the advice or
consent of the Congress.
the prpa restores proper balance between state and federal laws
Much mischief has been made of the fact that the PRPA puts into
statute the law as it has been uniformly and unarguably enforced for
many years. The act makes explicit that it is only purposeful killing
of patients that is a violation of the CSA. Gentlemen, that is the law
today. Even if the PRPA is not passed, the purposeful killing of a
patient by use of a controlled substance will remain a violation of the
CSA in forty-nine states. This act does not change the law for the
doctors of those forty-nine states. It simply restores the effect of
federal law to the one state that has abrogated its duty to extend
state interest in the preservation of life to an apparently expendable
segment of its population, namely those who are severely ill and
despairing of life.
It is also important to note that the PRPA would not overturn the
Oregon law allowing physician-assisted suicide. It would still be legal
for a practitioner to prescribe a lethal potion there; only it must not
contain a federally controlled substance. Sadly, there are a number of
other drugs that can accomplish this wicked purpose, and there is no
end to the inventiveness of people in whom are mixed the traits of
cleverness and contempt for the innate value of every human being.
While I believe that passage of the PRPA would diminish the number of
victims of medical killing, I do not expect the practice to come to an
end in Oregon. The states will retain the right to regulate medical
practice within their borders. Passage of the PRPA simply ends federal
collusion in the nasty business of doctors killing their patients.
objections to the prpa, and their refutation
As noted above, there are reasons of both law and justice to pass
the PRPA. Now let us review the four possible reasons for opposing it.
First logically, and not last in some opponents' motivation, it
would be reasonable to oppose the PRPA if one feels that euthanasia is
a public good to be promoted by federal policy. That would be contrary
to the unanimous vote in the Senate in denying public funding for
euthanasia and assisted-suicide, and contrary to the long history of
government protection of vulnerable classes of citizens. But such
opposition would be consistent with the effect of the Attorney
General's ukase.
The second argument raised against the PRPA is that it diminishes a
state's right to regulate the practice of medicine. Even before the
inclusion of the amendments introduced by Senator Hatch, this argument
held no water, for the bill does not overturn the Oregon act allowing
physician-assisted suicide. After the inclusion of the amendments,
which specifically declare that ``nothing in this subsection shall be
construed to alter the roles of the Federal and State governments in
regulating the practice of medicine,'' such an argument is not even
worthy of consideration. Unfortunately, physician-assisted suicide will
remain legal in Oregon even if this bill is passed. The federal
government, however, will no longer play the role of enabler. Actually,
if this bill is not passed, the states will gain new and
unconstitutional power to limit the right of Congress to control
interstate commerce of drugs. Without passage of the PRPA, it is the
states that have power of nullification over a federal law. This
country has already experienced considerable unhappiness as a result of
nullification theory, and the Congress would be ill-advised to
resurrect it now.
The third argument against the PRPA is that its language will have
a chilling effect on the willingness of doctors to prescribe adequate
doses of opioids to relieve the pain of dying patients, that they will
fear a meddlesome DEA bureaucracy eager to swoop down on them and throw
them in jail for 20 years when poor Grandma dies of cancer after her
final comforting dose of morphine. Since the language of the bill does
not adversely affect the license to prescribe opioids in 49 states,
this cannot be so. Quite the contrary, this bill puts into statute what
has heretofore been only administrative guideline, namely, that it is
legitimate medical purpose to use a controlled substance to relieve
pain even if that use increases the risk of death. This doctrine of
double effect will be the law whether the PRPA passes or not. Making it
explicit by statute should increase, not decrease, physician comfort in
prescribing opioids.
Opponents of the bill speak as if prosecutors distinguished between
homicide and natural death by using a Ouija board, rattles, and
feathers. those of you who have served as prosecutors know how far from
reality this is. The circumstances of a death, not the dose of the
drug, are determinative. By comparison, in this town of Washington
today, two men may die from having a knife stuck in their chests. One
case will be an unintended and tragic outcome from a failure to save a
patient during a coronary artery bypass operation. The other will be a
mugging occurring in an alley near the hospital. Just as it is easy to
see that the first death was unintentional and due to a procedure which
unavoidably increased the risk of death, so it is easy to see that the
second is purposeful and criminal. Deaths associated with opioid use
are just as easy to distinguish.
Much mischief is made by the euthanasiasts of the alleged
respiratory suppression effect of morphine. Like so much else they
promulgate, this is a gross distortion. Experienced clinicians
understand that there is an enormous difference between the effect of
morphine during its first days of use as compared with its effect in
the chronic setting. During the first few days of use, morphine may
cause sedation; if used recklessly it may even cause respiratory
suppression. But the respiratory system quickly acclimates to morphine
therapy. With continued use, morphine--even in high doses--relieves
pain, but does not make the patient stop breathing.\3\
---------------------------------------------------------------------------
\3\ P.D. Wall, ``The Generation of Yet Another Myth on the Use of
Narcotics [Editorial],'' Pain 73, no. 2 (Nov 1997): 121-2.
---------------------------------------------------------------------------
Another source of confusion is the fact that several different
pharmacologic classes of drugs are lumped together in the category of
controlled substances. Most of our discussion has been about opioids.
But opioids are virtually never used to intentionally induce death for
the very reason cited above. The recently published data from Oregon
shows that 100% of patients who died as a result of prescribed lethal
drugs took an overdose of a barbiturate.\4\ \5\ Only one of the
patients was even prescribed an opioid to accompany the barbiturate; in
that case the barbiturate alone would clearly have been fatal. With the
exception of the antiepileptic phenobarbital, barbiturtes have very
little legitimate medical use these days. There are much safer drugs
available to treat anxiety and insomnia. Indeed, it is this very lack
of safety that makes barbiturates attractive to the doctor intent on
killing his patient. My point is that this bill should not lead to
reduced use of opioids, because opioids are not the drugs used to kill
people; barbiturates are.
---------------------------------------------------------------------------
\4\ Arthur E. Chin, and others, ``Legalized Physician-Assisted
Suicide in Oregon--the First Year's Experience,'' New England Journal
of Medicine 340 (1999): 577-83.
\5\ A.D. Sullivan, K. Hedberg, and D.W. Fleming, ``Legalized
Physician-Assisted Suicide in Oregon--the Second Year,'' New England
Journal of Medicine 342, no. 8 (Feb 24 2000): 598-604.
---------------------------------------------------------------------------
The opponents of the PRPA may counter that the doctors will refrain
from prescribing opioids for fear that DEA or state regulatory
officials will misinterpret their use of opioids as intentionally
causing death, when in fact the patient died either of natural causes
or as an inadvertent effect of the drug. But the law already forbids
use of controlled substances to intentionally cause death in forty-nine
states. Failure to pass the PRPA will not eliminate this law. The
increased comfort concerning overweening regulation that physicians
crave will not come from defeating the PRPA, but from passing it. This
bill, for the first time, calls for federal dollars to be spent in the
training and education of both federal and local officials, so that
they will be more knowledgeable about proper palliative care, and less
likely to mistake good care for a violation of law. if the PRPA is not
passed, then there is nothing to improve the situation as it now
stands, nothing to reduce the regulatory fear that inhibits doctors
from prescribing drugs properly.
Fourth and finally, we need to address the possible objection to
this bill that it will be misinterpreted by doctors, and that their
misunderstanding of the bill will lead them to refrain from treating
pain adequately. In particular, opponents argue that this
misunderstanding will lead to a lower rate of prescribing opioids such
as morphine. That opponents of the bill make this argument is actually
a stunning concession that the language of the bill itself cannot
justify such fears. Let us set aside for a moment the other implication
of this argument, that men and women who have spent years mastering the
intricacies of anatomy, physiology, pharmacology, and therapeutics are
somehow too knuckle-headed to understand the plain meaning of a simple
law. This argument of a chilling effect via physician misunderstanding
is testable. In fact it has already been tested. Several states have
passed laws similar in impact to the PRPA. If the legislation were to
have a chilling impact on a doctor's willingness to prescribe opioids,
we should see a drop in, for example, morphine consumption in those
states subsequent to the passage of the laws.
In fact, the opposite is observed. For example, in the spring of
1996, Louisiana passed a law banning assisted suicide, while allowing
pain control that might unintentionally increase the risk of death. Per
capita morphine consumption in that state rose 80% that year, and had
nearly tripled by two years later. Similar results were seen when Iowa,
Rhode Island, Virginia, and Kansas passed similar laws. In fact, of the
top ten states in per capita morphine consumption in 1999, seven have
specific statutes against assisted suicide.\6\ Now this rise in
morphine consumption after passage of state laws resembling the PRPA
does not prove that such laws improve pain control. But the data
certainly disprove the contention that such passage will worsen pain
control by reducing opioid prescribing.
---------------------------------------------------------------------------
\6\ Drug Enforcement Administration, U.S. Department of Justice,
Statistics on Individual State Consumption of Morphine.
---------------------------------------------------------------------------
conclusion: eliminate the federal license to kill
Gentlemen, when I first earned my federal license to prescribe
controlled substances, I was proud that my country had recognized my
competence to relieve the suffering of my fellow citizens, and had
entrusted to me the privilege to prescribe these medications for their
benefit. It is deeply offensive to contemplate how this license of
which I was so proud, a license to palliate the misery of my patients
and fellow creatures, has been degraded to be a federal license to kill
them, state law permitting. Senators, remove this stain; erase this
blot. Vote to improve pain treatment and to protect the vulnerable
citizens of the country. Vote to allow honest physicians to relieve
pain without the stigma of a federal license to kill. Please pass the
Pain Relief Promotion Act.
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The Chairman. Dr. Caplan, we will turn to you.
STATEMENT OF ARTHUR L. CAPLAN
Mr. Caplan. Thank you, Mr. Chairman. It is an honor to have
the opportunity to address you and the committee on this
subject. It seems as if it has become obligatory in the hearing
to declare one's opposition to physician-assisted suicide. I am
someone who is opposed. I understand that there are people of
good will, as we heard from the Senators from Oregon who
disagree about physician-assisted suicide, but I am no friend
of legalization of physician-assisted suicide. I have tried to
argue for many, many years now in numerous publications and
opinion pieces, testimony to professional groups and
legislative bodies that legalization is bad public policy, and
I still believe it. I believe that legalization is not ethical
in a nation that might inadvertently make PAS more of an
expectation than an option.
To put the moral point more simply, a nation that has not
guaranteed a right to healthcare from the doctor is morally in
trouble in trying to make first a right to be aided in dying by
the doctor. So if we cannot get into the system by dint of
right, it seems to me morally problematic that we would be
creating rights to exit from this earth at the hands of a
doctor.
All that said, I am opposed to PRPA. If the chair will
indulge me, I have a statement. I will enter it into the
record. But I just wanted to talk a little bit about some of
the reasons for my opposition to this legislation, and I will
start it with a little story.
I was in a hospital a week ago doing what is sometimes
called an ethics consultation on a case. It was a little
hospital in Philadelphia. An individual was dying. She had
gotten different types of treatment for her cancer and was
receiving aggressive pain control, heavy use of narcotic drugs.
She had had different treatments stopped, and she certainly was
terminally ill and was going to die.
Her sister arrived from the West Coast well into the
process of her dying and accused the doctor of killing her
sister. She said, ``You are killing her. I do not trust what
you are doing with these drugs. I do not trust what you are
doing with this treatment. I think you are trying to kill my
sister.'' Her sister was certainly going to die and the sister
who had come from afar was torn up with emotion about guilt for
not having seen her for many years and her natural impulse was
to be protective in that circumstance.
But the charge hit home. The doctor was afraid about what
might happen with this kind of an accusation being levied, and
that is what I was doing there, was to try and talk through the
issue with this sister. And eventually, I am happy to report,
we did succeed in explaining to her why it was that the
treatment had shifted from aggressive care for the disease to
palliation and support for her dying, and the sister understood
that.
It took a long time, and in conversation later with the
doctor, not a hospice specialist, not someone expert at care of
the dying, just someone expert at the treatment of cancer, an
oncologist, he said, ``That scares me. I cannot stand that kind
of publicity. It would damage my medical career to have those
kinds of accusations levied against me, that I am being overly
aggressive or actually killing my patients.''
That is, in a nutshell, the source of my worry and concern
about the PRPA. I understand what the issues are with respect
to the battle over the Federal Government's role regarding
controlled substances. Whether that is a useful lever to come
after the Oregon action, I will leave to you and jurists and
others.
All I can say is the movement toward the aggressive relief
of pain is a fragile one. It has taken a long time to push
medicine in this direction. Some in the hospice movement, some
who are expert at the care of the dying are going quickly, but
others move very slowly. I believe the majority of healthcare
professionals are moving very slowly. It is a tentative,
fragile movement towards saying, I will manage pain
aggressively. We will not let the dying suffer. And putting
into play the murky world of intent at times when emotions run
high, when feelings run deep, as was true in this story I am
recounting to you from Philadelphia, it seems to me that will
be enough to put a chill, despite all the encouragement in the
PRPA, to use pain medicine aggressively. The very idea that
people might worry that they will be accused, that they will
have fingers pointed, and that authorities may come simply to
look may be enough to chill this nascent movement.
So I would argue that at the present time the correct
course is not to try and use the Controlled Substance Act and
Federal authority to try to undermine views about physician-
assisted suicide. My belief is that this is a fragile movement
toward aggressive treatment of pain. It should not be
interrupted at the present time. I do not worry about the
experts in dying who sit with me on this panel. I worry about
those doctors who deal with it intermittently, rarely, in
highly-charged climates, and what this legislation is going to
tell them, I believe, is go slower, be cautious, look out for
that DEA, worry about the allegation. And that, to me, is
enough of a reason not to pass this legislation at the present
time. Thank you.
The Chairman. Thank you, Dr. Caplan.
[The prepared statement of Mr. Caplan follows:]
Prepared Statement of Arthur L. Caplan
I am very pleased at the opportunity to address this committee. I
know that there are many people of good will who hold differing views
about the Pain Relief Promotion Act. Often the opinion held about this
proposed legislation is a function of where an individual stands with
respect to the vexing question of physician assisted suicide. That is
not so in my case.
I am no friend of the legalization of physician assisted suicide. I
have argued in numerous publications, opinion pieces and in testimony
to various professional groups and legislative bodies that legalization
of PAS is bad public policy. I believe that legislation is not ethical
in a nation that might inadvertently make PAS more of an expectation
than an option. And I believe that PAS is simply not necessary when
health care and medicine do their jobs and supply aggressive pain
control and suffering relief to those with terminal illnesses.
Ironically, it is my belief, that aggressive pain control is the
ethical route for medicine to take toward the dying that makes me wary
and ultimately opposed to the Pain Relief Promotion Act. It is my
opinion, based upon many years of studying and writing about the ethics
of care at the end of life, that this legislation will do more harm
than good.
My reasons for this position are: (1) the legislation risks
inhibiting the aggressive treatment of pain; (2) decisions about pain
control and the treatment of the dying should be kept as much as
possible in the hands of and under the discretion of health care
professionals, not legal authorities; and, that any attempt to control
or prohibit the practice of physician assisted suicide should not be
undertaken in the form of legislation that restricts, hinders or
threatens the willingness of doctors and other health care
professionals to aggressively relieve the pain and suffering of the
dying. The regulation or prohibition of the practice of PAS should be
accomplished through explicit efforts addressed to this practice, not
by indirection.
Why am I concerned about the chilling effect the proposed
legislation might have on doctor's and administrator's willingness to
insure that pain control is aggressive and thorough? It is well known
from many previous studies that physicians cite legal concerns as one
of the main reasons for their unwillingness to use narcotics and other
agents to control pain aggressively. Physicians often exaggerate their
risks of legal liability for end-of-life practices, even when the
practices are clearly permitted by law. Doctors and nurses may not
always fully understand what the law permits or does not, but when the
issue requires an assessment of intent in an area as fraught with
nuances and pitfalls as the end of life care then I believe that this
legislation will scare many doctors and nurses and administrators into
inaction in the face of pain.
The unfortunate reality is that physicians greatly overestimate the
possibility of legal repercussions. When criminal prosecutions carry
the possibility of sentences up to life imprisonment, as is the case
with the Pain Relief Promotion Act (PRPA), it is not surprising that
physicians may well be especially reluctant to take their chances with
the law. My concern about the chilling effect of PRPA on palliative
care is widely shared (Washington Post, February 2, 2000:A22).\1\
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\1\ Freer JP. Congress and the Pain Relief Promotion Act. West J
Med. 2000; 172:5-6.
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My second reason for concern is that I see no need to introduce
more legal oversight at the bedside of the dying. Studies consistently
indicate that physicians are unduly influenced by regulatory
considerations in their use of opioids and other drugs. For example,
triplicate prescriptions laws have resulted in marked declines in drugs
covered by the laws, with the substitution of less desirable drugs. If
the goal of the PRPA is to encourage pain control it is hard to see how
the introduction of more liability and greater prosecutorial authority
will achieve this end. Medicine has finally been prodded into action
and is trying hard to address the challenge of improving the experience
of dying and the management of end of life care as can be seen in
various medical publications such as the March 21 special issue of the
Annals of Internal Medicine which I had the honor to co-edit.
Passage of the PRPA risks undermining this hard won victory. The
opportunity which now exists to encourage doctors to move toward taking
pain control seriously should not be jeopardized by the implicit threat
that their actions will be held up to increased prosecutorial review.
When the care of patient involves stopping food and fluids,
dialysis antibiotics, pressors and other life-sustaining agents, it is
simply to complex to call to being to ask whether the treatment of pain
and suffering that results in what will be a certain death involves
intent to any degree. These decisions are hard enough without asking
health care teams to question each others motives and intentions and
attitudes when death of the patient is a certainty.
Lastly, I know that there are many who would say that the intent of
this legislation is not to engage the subject of PAS but rather to
encourage the morally responsible management of pain control. I would
respectfully maintain that intent, as I said above, is difficult to
ascertain. It is the case that some favor the enactment of legislation
that would inhibit the practice of PAS in Oregon or any other state
that moves to legalize this practice then it would seem to me the
appropriate course of action is to address the legality of such
decision head-on. Trying to ban or prohibit PAS by the regulation of
the practice of aggressive pain control is both an oblique approach to
a subject that demands a direct confrontation and imperils the welfare
of the dying by threatening to hold their pain and suffering hostage in
the name of banning of practice that has nothing to do with palliative
care.
I would urge this committee to reflect deeply on what is likely to
insure the best possible care for a dying relative or friend. It is
adding layers of regulatory and prosecutorial intrusion into the
clinical practice of end of life care or to let the practice of
aggressive pain control remain primarily in the hands of those at the
bedside? I firmly believe ti is the latter that will serve the best
interest of those who are terminally ill.
STATEMENT OF RABBI J. DAVID BLEICH
Rabbi Bleich. Thank you very much, Mr. Chairman, members of
the committee. I am deeply appreciative of this opportunity to
appear before you to present the perspective of Jewish law and
tradition with regard to the provisions of the Pain Relief
Promotion Act of 2000.
The salutary positive effects of this proposed legislation
are certainly ones that Jewish tradition would support to the
fullest extent. The provisions of the Act promote palliation of
pain even when death as a result of use of that pain medication
is possible and even plausible. That position is usually
expressed as based upon the double effect theory. I will not
presume upon your time to trace the history of the double
effect theory and to trace its origins to sources in rabbinic
law. Judaism accepts the double effect theory with a caveat
that when the effect is inescapable, the inescapability of the
unwanted and immoral effects imputes intent.
Jewish law posits other obligations with regard to
palliation of pain even when the palliative measures are
themselves hazardous and carry with them the danger of
foreshortening life. It is an assumption of Jewish law, and I
believe it to be an irrebuttable assumption of Jewish law, that
pain is itself a cause of death and that particularly in the
case of a terminal patient, the trauma and stress associated
with pain can hasten the death of the otherwise terminal
patient.
Prolongation of life is a value which is fundamental to
Judaism. All life is of infinite value and every moment of
human life is of infinite value. Judaism, in general--with some
exceptions, of course--advocates the prolongation of life.
Since Judaism regards pain as itself a danger, it regards the
palliation of pain not only as permissible but as mandatory,
and when that palliation is accompanied by hazards, it treats
the hazards associated with the palliation in a manner no
differently from that in which it treats hazards associated
with any medical practice.
There is very little that a physician has in his black bag
that does not pose a danger. Major surgery is very dangerous
for everyone, and more dangerous to the weak, the infirm, and
those suffering from debilitating illnesses. In any case in
which a hazardous protocol is advocated, a balancing act must
be entered into. Risk-benefit ratios have to be established.
When the risks are prudent, then by all means the procedure
should be instituted, and the same is true with regard to
medication that may have the effect of hastening death,
including palliative care medication.
For the first time, the Pain Relief Promotion Act enshrines
in statute that notion, the notion that medications may be used
to palliate pain, even if there is the distinct possibility
that they will hasten death, so long as there is no intent of
hastening death. And the presumption in every case is wisely
enshrined in the statute in favor of the physician. The
physician need not offer his motives as an affirmative defense.
Quite on the contrary, his intent to cause death must be
demonstrated before the sanctions of the statute can be invoked
against him.
The Pain Relief Promotion Act will not have the effect of
reducing the incidence of physician-assisted suicide. To be
quite candid, I would not at all be distressed if it did. But
in point of fact, I am not an optimist to believe that it will.
What it will accomplish is to remove the imprimatur of the
Federal Government from that process. The Assisted Suicide
Funding Retribution Act of 1997 recognized that the taxpayers
of all the States of this country should not be implicated
through the use of their tax dollars in assisting suicide. This
Act, recognizing that these drugs can be used only with regular
licensure, recognizes that every citizen is implicated in the
use of such drugs for purposes of hastening death.
Hastening of death has been recognized since the 16th
century in Hales v. Petit as a breach of the King's peace. In a
usage that to us in the 21st century seems quaint and archaic,
in that court decision, the term ``king'' is spelled with a
capital ``K''. It is the reference, I would believe, to the
King of kings, and assistance in suicide, the taking of any
human life, is a breach of the peace of the King of kings.
The legal system has a way of incorporating Judeo-Christian
values in secular language. The firm opposition of the common
law legal tradition to suicide and assisted suicide is firmly
rooted in those values. I will not presume upon your time. I am
already overtime.
Let me conclude with a rabbinic aphorism. Man has no choice
with regard to coming into this world, with regard to his life,
or with regard to his death. But nowhere is a similar aphorism
with regard to the fact that man has no power or control over
his pain, suffering, and misery. While man does not have the
right to take his own life in his hands, he does have the right
to take pain into his hands and control, and it is precisely
those dual moral principles which are expressed and enforced by
the Pain Relief Promotion Act. I thank you.
The Chairman. Thank you, Rabbi.
[The prepared statement of Rabbi Bleich follows:]
Prepared Statement of Rabbi J. David Bleich
My name is J. David Bleich. I am a Professor of Law at the Benjamin
Cardozo School of Law, Professor of Talmud and Director of the graduate
program in Jurisprudence and Family Law at the Rabbi Issac Elchanan
Theological Seminary, as well as Herbert and Florence Tenzer Professor
of Jewish Law and Ethics at Yeshiva University. I have been requested
by the Union of Orthodox Jewish Congregations of America to testify
before the Senate Committee on the Judiciary regarding the proposed
Pain Relief Promotion Act.
Permit me to make two points at the outset. Judaism places the
highest importance on palliation of pain, particularly in the case of
terminal patients. Jewish law regards pain suffered by terminal
patients as life-threatening, in the sense that such pain has the
potential for compromising the brief longevity anticipated for the
terminal patient. I believe this teaching to be grounded upon
physiological realia. I also believe that this principle represents an
irrebuttable presumption of Jewish law, not subject to empirical
refutation. Such presumptions are recognized in virtually every legal
system. A good example is the common law presumption that a husband is
the father of the child of his lawfully wedded wife so long as he was
physically within the boundaries of the five seas of England during the
requisite time period, with the result that no person can be heard by a
court of law to challenge that presumption.
In light of its presumption regarding the life-threatening nature
of pain, Judaism permits, and indeed mandates, violation of religious
strictures such as Sabbath restrictions and the like in order to
alleviate the pain of patients in extremis. For precisely the same
reason, Jewish law endorses use of pain relieving drugs even in
situations in which administration of the drug carries with it a
statistical danger of foreshortening life. That risk is treated no
differently from the risk associated with any other hazardous procedure
which, when successful, is designed to prolong life.
It should also be noted that, for similar reasons, Jewish law
sanctions violation of religious law in order to assuage the otherwise
uncontrollable crying of a child, as in the case of an infant who
becomes traumatized upon locking himself in a room. There is also
substantial rabbinic authority sanctioning acceptance of potentially
hazardous procedures for elimination of chronic pain even in the
absence of a terminal condition.
Accordingly, Jewish law and tradition would enthusiastically
endorse the provisions of H.R. 2260 designed to encourage more
extensive and more effective palliation of pain.
Let me preface my second point by saying that at times I find
myself suffering from intellectual schizophrenia. There are occasions
on which I do not know whether to don the jurist's wig or the rabbinic
skullcap; occasions on which I do not know whether I should respond as
a Professor of Law or an expositor of Halakhah (Jewish law). The
responses of those two personae are not always univocal. In addressing
the question of assisted suicide, however, I experience no conflict.
Judaism teaches that suicide is an offense against the Deity who is
the Author of life. Common law regards suicide as an offense against
the temporal sovereign. The interest of the State in preventing suicide
was first articulated in the sixteenth century British case, Hales v.
Petit. In Hales the court enumerated a number of diverse objections to
suicide. One crucial consideration is that suicide is a crime
``[a]gainst the King in that thereby he has lost a subject . . . one of
his mystical members,'' Suicide my be prevented--and punished--by the
King because it constitutes interference with his rights as monarch. In
his Commentaries, Blackstone writes that ``[T]he suicide is guilty of a
double offense; one spiritual in evading the prerogative of the
Almighty, and rushing into his immediate presence uncalled for; the
other temporal, against the king, who hath an interest in the
preservation of all his subjects . . .''
The common law notion of preservation of life as a monarchical
prerogative has been transformed in American legal theory into an
inherent function of government. Thus Thomas Jefferson wrote, ``[T]he
care of human life and happiness, and not their destruction, is the
first and only legitimate object of good government,'' In the United
States, the State interest in prolongation of life has been tempered by
the decision of the New Jersey Supreme Court in In re Quinlan, which
expressed the notion that the State's interest weakens and the
individual's right to privacy grows ``as the degree of bodily invasion
increases and the prognosis dims.''
However, Hales identifies a further State interest in prohibiting
suicide, in declaring that suicide is an offense against the King in
that ``the King who has the government of the people [takes] care that
no evil example be given them.'' Killing invites imitation; therefore,
self-destruction serves as an ``evil example'' encouraging emulation by
other susceptible members of society. Suicide ``infringe[s] upon the
King's peace'' because a suicide is not an isolated individual act. The
harm is not really to the king as an individual but constitutes an
offense against society because of potential harm to others. If openly
permitted, suicide diminishes commitment to the preservation of life
and compromises the State's interest in preserving respect for life
which constitute the fundamental underpinning of the social fabric.
Our legal system, in balancing the interests of the individual
against those of the State, cogently distinguishes between refusal or
withdrawal of life sustaining measures and overt, active termination of
life. Medicine is not merely an art or a science; it is a calling and
vocation. Judaism teaches that physicians practicing the healing arts
function as agents of the Divine healer. Physicians are charged with
preserving and prolonging life; in taking the Hippocratic oath they
solemnly pledge themselves to do so. Physician-assisted suicide--or, as
I have called it, ``thanatology,'' the science of death--is
antithetical to the values and mores of the healing arts and dare not
be allowed to emerge as a new area of medical specialization.
Availability of physician-assisted suicide represents a Copernican
revolution in the physician-patient relationship. Physicians would
perforce become agents of death rather than of life, purveyors of
despair rather than of hope. Legalization of physician-assisted suicide
would pose the greatest threat to the poorest and most vulnerable of
our patients, those without the means and the stamina to withstand
pressure, both subtle and not so subtle, for acceptance of termination
of life. For those reasons--and for others as well--the New York State
Task Force on Life and the Law on which I serve was unanimous in its
recommendation against legalization of physician-assisted suicide.
It is the issue of assisted suicide--and only the issue of assisted
suicide--that is posed by H.R. 2260. This Act permits and indeed
encourages palliative care in a manner heretofore never enshrined in
statute. The bill pays full deference to the physician's judgment with
regard to dosage and titration, so long as there is no demonstrable
intent to cause death. The bill establishes no new investigatory or
regulatory process; it mandates no expansion of Federal authority. In
no way does it hamper the practice of medicine or interfere with the
physician's exercise of professional judgment. Its effect is to
encourage meaningful pain management and to provide full protection to
medical practitioners who provide palliative care.
The bill recognizes that, at present, physicians are woefully
undertrained in pain management and provides funding to expand
educational programs in that area. Such training programs should
certainly stress that a physician engaged in bona fide pain palliation
need have no fear of adverse legal consequences.
The effect of H.R. 2260 is solely to remove the Federal imprimatur
for assisted suicide. Controlled substances may be dispensed only with
a Federal license and only for purposes approved by the Federal
government. Use of controlled substances in physician-assisted suicide
implies that such action is not inimical to the mores of our society as
expressed by the Federal government. Federal licensure implicates the
citizens of all States in an act that is morally repugnant to the
majority of our populace and offensive to the traditions of this
country. Forbidding such use will not prevent assisted suicide in a
jurisdiction in which it is not otherwise contrary to law; rather, it
loudly and unequivocally affirms the Federal government's commitment to
the moral values and common law principles enunciated in Hales.
The Chairman. Dr. Foley, we will turn to you.
STATEMENT OF KATHLEEN FOLEY, M.D.
Dr. Foley. I wish to express my appreciation for the
opportunity to speak before this hearing and to express my
concerns about the proposed legislation and my opposition to
it.
For the last 25 years, I have directed a program in
clinical pain management and research at Memorial Sloan-
Kettering Cancer Center. I have chaired two World Health
Organization cancer unit expert advisory panels that have
developed guidelines for the management of cancer pain and for
initiatives in palliative care.
Americans deserve humane, compassionate care at the end of
life. National initiatives in pain research and education are
urgently needed. I thank the authors of the PRPA for attempting
to address some of the barriers to an inadequate pain
management and to palliative care. Yet, I remain concerned that
the current Act sends the wrong message to drug regulators,
physicians, and patients about the medical use of controlled
substances.
As proposed, the bill provides insufficient funding to have
any real impact on pain and palliative care education and
training. It does not begin to address the seven
recommendations to improve end-of-life care that were made by
the Institute of Medicine of the National Academy of Sciences
in its report entitled, ``Approaching Death,'' and I have
included these in my transcript.
And last, it will have no impact on changing the flawed
monitoring process of the Oregon Death With Dignity Act. It has
prevented a full, open, and nonpartisan evaluation of assisted
suicide practices in Oregon.
The Chairman. Dr. Foley, if I could just interrupt you for
a second, I have to go meet with the majority and minority
leaders, so I am asking Senator Sessions to continue chairing
this.
Senator Sessions, I have also allowed a period of time for
Senator Wyden to ask questions this morning as a guest of the
committee.
Senator Wyden. Before you leave, Mr. Chairman, I just want
to express my thanks to you.
The Chairman. Sorry to interrupt you. I apologize.
Senator Sessions [presiding]. Excuse me, Dr. Foley. Please
go ahead.
Dr. Foley. The wrong message. Pain and palliative care
experts have defined clear distinctions between pain management
and palliative care and physician-assisted suicide. Yet, it has
been the advocates for physician-assisted suicide who have used
the arguments that opioids such as morphine kill and then have
tried to relate these practices.
Yet, there is a preponderance of evidence that demonstrates
that the proper use of opioids, narcotics like morphine, in
patients with chronic pain, as well as in patients at the end
of life, does not hasten their death. There is accumulating
data to suggest that, in fact, the proper use of opioids may,
in fact, prolong their lives. Studies by Dr. Bresia at Calvary
Hospital in New York City show that there is no correlation
between the dose of opioid that a patient receives in the last
weeks of life and the timing of their death. Studies of dying
patients who are being withdrawn from respiratory support
demonstrate that those patients who received morphine received
longer than those who did not receive morphine. Studies
recently published by the British hospices show no difference
in the time to death between those patients who were sedated to
control their symptoms as compared to those who were not
sedated.
And finally, the doses of opioids that are often used to
treat patients at the end of life are highly variable. The
great majority of dying patients are receiving doses in a range
equivalent to what you and I might receive as part of post-
operative pain management. These doses are safe and effective.
In short, the underpinnings of this legislation are not
based on scientific evidence. It would be unwise to
institutionalize the myth into law that pain medications hasten
death.
In the last 25 years, through the development of scientific
guidelines and a natural experiment of treating cancer patients
and noncancer pain patients with analgesic drugs, specifically
opioids like morphine, we have shown that patients can take
these drugs for months to years and continue to obtain pain
relief. We have demonstrated that they do not develop
respiratory depression with increasing doses because tolerance
develops to the respiratory depressant side effects. Increasing
the availability of these drugs for medical purposes is not
associated with an increase in drug diversion.
Yet, lack of knowledge about pain assessment and treatment,
lack of knowledge about the use of these drugs and the control
of symptoms in the dying, coupled with a strong regulatory
environment, have led to significant under-treatment and
underassessment of patients with pain, particularly at the end
of life. Working with Mr. David Joranson and Dr. June Dahl at
the University of Wisconsin and many others, we have advocated
for a balanced drug policy to assure that opioid analgesics
will be available for legitimate medical purposes. We have also
worked through the World Health Organization with the
International Narcotics Control Board, who have strongly urged
its member countries, like the United States, to place a high
level of importance on the medical use of opioids for the
treatment of patients with pain.
The PRPA Act, by expanding the authority of the Controlled
Substance Act, will disturb the balance that we have all in the
pain community worked so hard to create. Physician surveys in
my own State by the New York State Department of Health have
shown that a strict regulatory environment negatively impacts
on physicians' prescribing practices. It leads them to
intentionally under-treat patients with pain because of concern
of regulatory oversight.
In the last 5 years, there has been increased attention to
inadequate care of patients at the end of life and to the
inadequacy of pain management in patients throughout the course
of their medical illness. Five studies have consistently shown
that we have a health care system that prevents patients from
obtaining appropriate pain assessment and treatment and
appropriate palliative care. These include studies that show
that only 37 percent of children with cancer in the last days
of life received adequate treatment for their pain, that less
than 25 percent of elderly patients in nursing homes received
any approaches for their pain management.
Minorities are particularly impacted by the under-treatment
of pain and lack of access to palliative care. Studies show, in
fact, that this under-treatment occurs in the post-operative
setting, in trauma, in emergency rooms, and in cancer pain. And
complicating this under-treatment is a lack of availability of
opioid drugs in the pharmacies that serve these minority
neighborhoods. This lack of access leads to needless suffering.
I am emphasizing these studies only to suggest that this
current Act will do little to alter the current system of care
that impedes particularly vulnerable populations, such as
children, the elderly, and minorities, from receiving adequate
pain management and palliative care.
On the issue of insufficient funding, both the PRPA and the
Hatch amendments establish a program for pain and palliative
care research and quality within the Agency for Healthcare
Research and Quality. The problem with this is that, as much as
it is a laudable endeavor, we have in place sufficient
guidelines for pain management. They have already been issued
by the agency. The problem is not a lack of guidelines or lack
of information but an inability to implement the information we
currently have into practice.
At the present time, the PRPA authorizes $5 million to the
Health Resource and Service Administration grants program. This
is a small amount of money to create an enduring change for the
50 million Americans who suffer daily with chronic pain and an
equal number who have episodes of acute pain and the 2.4
million Americans who die each year, 70 percent of whom report
significant pain.
It does not include funding for demonstration projects that
put into practice pain management and palliative care programs.
It does not support role model physicians in facilities around
the country. What we need in every community hospital is an
expert physician and nurse who can serve both as a role model
and resource to their peers and patients about appropriate pain
management and palliative care.
Senator Sessions. Dr. Foley, if you could wrap up, and we
can make your whole remarks part of the record, though.
Dr. Foley. Lastly, the Hatch amendment has suggested the
creation of a decade of pain control and research beginning in
the year 2001. I want to thank Senator Hatch for his advocacy
for pain patients in the past, but to create an initiative
without an implementation process and an appropriate funding
stream is an empty promise to patients suffering with pain.
Senator Sessions. Thank you very much.
[The prepared statement of Dr. Foley follows:]
Prepared Statement of Kathleen M. Foley, M.D.
Mr. Chairman and Committee: I am Dr. Kathleen M. Foley, Attending
Neurologist, in the Pain & Palliative Care Service at Memorial Sloan-
Kettering Cancer Center and Professor of Neurology, Neuroscience and
Clinical Pharmacology at the Cornell University Medical College.
I wish to express my appreciation for the opportunity to speak
before this Senate Hearing and to express my concerns about the
proposed legislation and my opposition to it.
For the last 25 years, I have directed a program in clinical pain
management and research at Memorial Sloan-Kettering Cancer Center. I
have chaired two World Health Organization Cancer Unit Expert Advisory
Panels that have developed guidelines for the management of cancer pain
and for initiatives in palliative care.
Americans deserve humane, compassionate care at the end of life.
National initiatives in pain research and education are urgently
needed. I thank the authors of the PRPA for attempting to address some
of the barriers to inadequate pain management and palliative care.
Yet, I remain concerned that the Pain Relief Promotion Act sends
the wrong message to drug regulators, physicians and patients about the
medical use of controlled substances. As proposed, the Bill provides
insufficient funding to have any ``real'' impact on pain and palliative
care education and training. It does not begin to address the seven
recommendations to improve end of life care made by the Institute of
Medicine of the National Academy of Sciences in its report entitled
``Approaching Death.'' (See attached) Lastly, it will have no impact on
changing the flawed monitoring process of the Oregon Death with Dignity
Act that has prevented a full, open and non-partisan evaluation of
assisted suicide practices in Oregon.
the wrong message
Pain and palliative care experts have defined clear distinctions
between pain management and palliative care, and physician assisted
suicide. Yet, it has been the advocates for physician assisted suicide
who have used the argument that opioids, such as morphine, kill and to
try to relate these practices. Yet, there is a preponderance of
evidence that demonstrates that the proper use of opioids in patients
with chronic pain, as well as in patients at the end of life, does not
hasten their death. There is accumulating data to suggest that the
proper use of opioids may in fact prolong their lives.
Studies by Dr. Brescia at Calvary Hospital in New York City show
that there is no correlation between the dose of opioids a patient
receives in the last weeks of life and the timing of their death.
Studies of dying patients who were being withdrawn from respiratory
support demonstrate that those patients who received morphine lived
longer than those who did not receive morphine. Studies recently
published from a series of British hospices show no difference in the
time to death between those patients who were sedated to control their
symptoms as compared to those patients who were not sedated. Finally,
the doses of opioids that are often used to treat patients at the end
of life are highly variable. The great majority of dying patients are
receiving doses in a range equivalent to what you or I might receive as
part of postoperative pain management and these doses are safe and
effective. In short, the underpinnings of this legislation are not
based on scientific evidence. It would be unwise to institutionalize
the myth into law--that pain medications hasten death.
In the last 25 years through the development of scientific
guidelines and the natural experiment of treating cancer pain patients
and non-cancer pain patients with analgesic drugs, specifically
opioids, we have shown that patients can take opioid drugs for months
to years and continue to obtain pain relief. We have demonstrated that
they do not develop respiratory depression with increasing doses
because tolerance occurs to the respiratory depressant side effects.
Increasing the availability of these drugs for medical purposes is not
associated with an increase in diversion to an illegal market. Yet,
lack of knowledge about pain assessment and treatment, the use of
analgesic drugs, and the control of symptoms in the dying coupled with
a strong regulatory environment have led to the significant
undertreatment and underassessment of patients with pain, particularly
at the end of life.
Working with Mr. David Joranson and Dr. June Dahl at the University
of Wisconsin and with many others, we have advocated for a balanced
drug policy to assure that opioid analgesics will be available for
legitimate medical purposes. We have also worked with the International
Narcotics Control Board who has strongly urged its member countries,
including the U.S., to place a high level of importance on the medical
use of opioids for the treatment of patients with pain.
The PRPA, by expanding the authority of the Controlled Substance
Act, will disturb the balance that we have worked so hard to create.
Physician surveys by the New York State Department of Health have shown
that a strict regulatory environment negatively impacts physician
prescribing practices and leads them to intentionally undertreat
patients with pain because of concerns of regulatory oversight.
In the last five years, there has been increased attention to the
inadequate care of patients at the end of life, and to the inadequacy
of pain management in patients throughout the course of their medical
illness. Five studies have consistently shown that we have a health
care system that prevents patients from obtaining appropriate pain
assessment and treatment and appropriate palliative care. These studies
show that 37% of children with cancer in the last days of life were
inadequately treated for their pain by parent report. Recent data from
nursing home surveys demonstrate that 40% of elderly cancer patients
have pain but less than 25% are receiving any form of analgesic drug
therapy. Minorities are particularly impacted by the undertreatment of
pain and lack of access to palliative care. Studies show that
minorities are undertreated for their postoperative, traumatic, and
cancer pain. Complicating this undertreatment is the lack of
availability of opioid drugs in pharmacies that serve minority
neighborhoods. This lack of access leads to needless suffering.
Finally, the SUPPORT study of 10,000 seriously ill hospitalized
patients demonstrated that 50% have significant pain in the last days
of life.
I am emphasizing these studies only to suggest that the current
Pain Relief Promotion Act will do little to alter the current system of
care that impedes particularly vulnerable populations such as children,
the elderly, and minorities from receiving adequate pain management and
palliative care.
insufficient funding
The PRPA and the Hatch amendments establish a program for pain and
palliative care research and quality within the Agency for Healthcare
Research and Quality ``to develop and advance scientific understanding
of palliative care and to collect, disseminate and make available
information on pain management, especially for the terminally ill,
professionals and the general public.'' This is clearly a laudable
endeavor. However, we have in place sufficient guidelines for pain
management that have already been issued by the Agency for both acute
pain and chronic cancer pain. The problem is not a lack of guidelines,
or a lack of information but an inability to implement the information
that we currently have into practice. This requires not only the
training of health care professionals and the public but the provision
of payment to physicians for their services and payment for the costly
prescription drugs.
The PRPA authorizes $5 million dollars for a Health Resources and
Services Administration grants program. This is a small amount of money
to create an enduring change for the 50 million Americans who suffer
with chronic pain, and an equal number who have episodes of acute pain,
and the 2.4 million Americans who die each year.
What the PRPA does not include is funding for demonstration
projects that will put into practice pain management and palliative
care programs. For example, demonstration projects that will evaluate
how to bridge the gap between palliative care and hospice care
programs; demonstration projects that will support role models within
institutions such as the VA and PDIA Faculty Scholars Program.
What is needed in every community hospital is an expert physician
and nurse who can serve both as role models and resources to their
peers and to patients about appropriate pain management and palliative
care.
Lastly, the Hatch amendment has suggested the creation of ``The
Decade of Pain Control and Research'' beginning in the year 2001. I
want to thank Senator Hatch for his advocacy for pain patients, but to
create an initiative without an implementation process and an
appropriate funding stream is an empty promise to patients suffering
with pain.
There is currently no center on pain research at NIH. There is not
even an office to coordinate pain research initiatives. There is no
external advisory board to provide input and oversight to pain
initiatives. The need for a coordinated, focussed effort with strong
leadership and an external advisory board has been strongly advocated
by the pain community but has not been implemented at a governmental
level and this Bill fails to respond to this need.
In short, this proposed legislation does not adequately respond to
the Institute of Medicine recommendations to improve end of life care
and falls significantly short of institutionalizing national programs
in pain relief and palliative care.
the oregon situation
If this Committee wishes to address its concerns about physician
assisted suicide in Oregon, it should recognize that it is
barbiturates, not opioids, that are currently being prescribed to aid
patients in death. Barbiturates are not used in pain management because
they are ineffective as analgesics.
The current environment in Oregon has suppressed open discussion
and limited the ability to evaluate whether Oregonians do, in fact,
receive quality end-of-life care. The current monitoring process is
flawed because it only interviews physicians who have aided patients in
death, thereby devaluing the medical decisions of physicians who have
refused to assist patients in suicide.
In closing, as you consider this legislation, it is important to
recognize that proposals that are well meaning and well intentioned
should have as their first priority the goal to improve pain management
and palliative care for those who so desperately need it.
institute of medicine recommendations on the care of patients at the
end of life
From: Approaching Death
Recommendation 1: People with advanced, potentially fatal illnesses
and those close to them should be able to expect and receive reliable,
skillful, and supportive care.
Recommendation 2: Physicians, nurses, social workers, and other
health professionals must commit themselves to improving care for dying
patients and to using existing knowledge effectively to prevent and
relieve pain and other symptoms.
Recommendation 3: Because many problems in care stem from system
problems, policy-makers, consumer groups, and purchasers of health care
should work with health care practitioners, organizations, and
researchers to
Strengthen methods for measuring the quality of life and
other outcomes of care for dying patients and those close to
them;
Develop better tools and strategies for improving the quality
of care and holding health care organizations accountable for
care at the end-of-life;
Revise mechanisms for financing care so that they encourage
rather than impede good end-of-life care and sustain rather
than frustrate coordinated systems of excellent care; and
Reform drug prescription laws, burdensome regulations, and
state medical board policies and practices that impede
effective use of opioids to relieve pain and suffering.
Recommendation 4. Educators and other health professionals should
initiate changes in undergraduate, graduate, and continuing education
to ensure that practitioners have relevant attitudes, knowledge, and
skills to care well for dying patients.
Recommendation 5. Palliative care should become, it not a medical
specialty, at least a defined area of expertise, education and
research.
Recommendation 6. The nation's research establishment should define
and implement priorities for strengthening the knowledge base for end-
of-life care.
Recommendation 7. A continuing public discussion is essential to
develop a better understanding of the modern experience of dying, the
options available to patients and families, and the obligations of
communities to those approaching death.
references
Bernabei R, Gambassi G, Lapane K, et al Management of pain in the
elderly patients Cancer. JAMA. 1999;281:136.
Breitbart W, MacDonald MV, Rosenfeld B, et al. Pain in ambulatory
AIDS patients. I. Pain characteristics and medical correlates. Pain.
1996;68:315-21.
Brescia FJ, Portenoy RK, Ryan M, Drasnoff L, Gray G. Pain, opioid
use and survival in hospitalized patients with advanced cancer. J Clin
Oncology. 1992;10:149-155.
Cavanaugh TA. The ethics of death-hastening or death causing
palliative analgesic administration to the terminally ill. JPSM.
1996;12:248-254.
Chaters S. Terminal sedation. 11th International Congress on Care
of the Terminally Ill, Montreal. September 10, 1996.
Cleeland CS, Gonin R, Hatfield AK, et al. Pain and its treatment in
outpatients with metastatic cancer. N Engl J Med. 1994;330:592-6.
Cohen FL. Postsurgical pain relief patients' status and nurses'
medication choices. Pain. 1980;9:265-74.
Emanuel AJ, Fairclough DL, Slutsman J, Emanuel L. Understanding
economic and other burdens of terminal illness: the experience of
patients and their caregivers. Ann. Int. Med. 2000;132(6):452-459.
Foley KM, Hendin H. The Oregon Report. Don't Ask Don't Tell. 1999;
29 (3):37-42.
Foley KM: Medical Issues Related to Physician-Assisted Suicide.
Testimony, House Judiciary Subcommittee on the Constitution, Hearing on
Physician-Assisted Suicide. April 29, 1996.
Foley KM: Competent care for the dying instead of physician-
assisted suicide. NEJM 1997; 336(1):54-58.
Foley KM. The relationship of pain and symptom management to
patient requests for physician-assisted suicide. JPSM. 1991;6:289-297.
Freeman HP, Payne RP. Racial injustice in health care. NEJM.
2000;342(14):1045-1047.
Ganzini L, Nelson HD, Schmidt TA, Kraemer DF, Delorik MA, Lee MA.
Physicians' experiences with the Oregon Death with Dignity Act. NEJM.
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Institute of Medicine. Recommendations for Care at the End of Life.
Approaching Death. Field MJ, Cassel CK. (eds). National Academy Press,
Washington, DC. 1997.
Jacox A, Carr DB, Payne R, et al. Management of cancer pain.
Clinical practice guideline No. 9. Rockville, MD: Agency for Health
Care Policy and Research. 1994:257. (AHCPR public no. 94-0592).
Joranson D. U.S. Senate Hearing on Pain Management and Improving
End of Life Care. October 13, 1999. (See University of Wisconsin Pain &
Policy Studies Group.
Joranson DE, Ryan KM, Gibson AM, Dahl JL. Trends in medical use and
abuse of opioid analgesics. JMA. 2000;283(13)1710-4.
Morrison SR, Wallenstein S, Natale DK, Senzel RS, Huang LL. ``We
don't carry that''--Failure of pharmacies in predominantly nonwhite
neighborhoods to stock opioid analgesics. NEJM. 2000;342(14):1023-26.
Mount B. Morphine drips, terminal sedation and slow euthanasia
definitions and facts, not anecdotes. J. Pall. Care. 1996;12:31-37.
Oates JD, Snowdon SL, Japson DW. Failure of pain relief after
surgery: attitudes of ward staff and patients to postoperative
analgesia. Anesthesia. 1994:49:755-8.
Portenoy RK. Morphine infusions at the end of life. The pitfalls in
reasoning from anecdote. J Pall. Care. 1996;12:44-46.
Solomon M, O'Donnell L, Jenning B, et al. Decisions near the end of
life: professional views of life-sustaining treatments. American J.
Public Health. 1993;83:14-21.
The New York State Public Health Council. Breaking down the
barriers to effective pain management. Recommendations to improve the
assessment and treatment of pain in New York State. Report to the
Commissioner of Health Barbara A. DeBuono, M.D., M.P.H. January, 1998.
The SUPPORT Principal Investigators. A controlled trial to improve
care for seriously ill hospitalized patients the Study to Understand
Prognoses and Preferences for Outcomes and Risks of Treatments
(SUPPORT). JAMA. 1996;275:1232.
Todd KH, Samaroo N, Hoffman JR. Ethnicity as a risk factor for
inadequate emergency department analgesia. JAMA 993;269:1537-9.
Von Roenn JH, Cleeland CS, Gonin R, Hatfield AK, Pandya KJ.
Physician attitudes an practice in cancer pain management: a survey
from the Eastern Cooperative Oncology Group. Ann Intern Med.
1993;119:121-6.
Wilson WC, Smedira NG, Fink C, McDowell JA, Luce JM. Ordering and
administration of sedatives and analgesics during the withholding and
withdrawal of life support from critically ill patients. JAMA
1992;267;267:949-953.
World Health Organization. Cancer pain relief and palliative care.
World Health Organization. Geneva, 1990.
Senator Sessions. Dr. Hunter.
STATEMENT OF WALTER R. HUNTER, M.D.
Dr. Hunter. Mr. Sessions, members of the committee, ladies
and gentlemen, I am a full-time hospice physician with
VistaCare Hospice, the second largest provider of hospice
services in the United States. Nothing in this bill will change
what I do daily in my work as a hospice physician and nothing
in this bill will diminish our work at VistaCare to
aggressively and adequately treat pain.
You have heard many of the concerns expressed about this
legislation as it originally stood. There are amendments before
you that I think strengthen this bill and that I wholeheartedly
support. I think it is a timely, necessary, and explicit
clarification of the existing Controlled Substance Act for the
reasons that have been already enumerated.
Currently, if I were to practice in 49 States, I would be
subject to penalties for committing assisted suicide
euthanasia. I would not be in Oregon based on an erroneous
interpretation, I believe, by Attorney General Reno. So I think
this bill does clarify existing CSA law.
I think that it is important to understand that in our
clinical practice, there are times where the edge can seem to
be very, very tight between intention and clinical practice,
but I do believe that people that understand the principle of
double effect, that understand how to use these medications,
can be very clear in their intent, in their documentation. I do
not believe that physicians need worry. And, in fact, I welcome
the opportunity to have codification of the ethical principle
of double effect.
This bill establishes that the United States Government
stands firm in its commitment to ensure that patients receive
the very best there is available in palliative care, but that
the deliberate killing of those patients is neither endorsed
nor encouraged by the United States Government. It is not
unreasonable for the Controlled Substance Act to prohibit
physician-assisted suicide or euthanasia as a condition for
maintaining a DEA license. All licenses carry certain
privileges and certain restrictions. It is disingenuous to
believe a DEA license should have no restraints.
In addition to all of these benefits, this legislation does
put end-of-life care, pain and symptom management, and the care
of our citizens in the spotlight at the center of the stage.
While it certainly is not the final word in a proactive
response to the needs of our aging population and dying
patients, it is an important start. As we study our progress in
further developing hospice, palliative care, and pain treatment
for our citizenry, Congress will be called upon again to
recommit itself in principle and practice to ensuring comfort
for all people who face serious or terminal illness. This
legislation is, I believe, a giant step toward that commitment.
As a physician, I am ashamed to admit that the vast
majority of our nation's medical schools and residency programs
have simply failed to make medical ethics, pain and symptom
management priorities in their curricula. This knowledge,
however, is absolutely essential for physicians to properly
provide excellent care for patients. Physicians can and must
learn and understand thoroughly the principle of double effect
and how that principle is incorporated into the clinical
practice of palliative medicine and the intent of this
legislation.
This legislation does provide for much needed education in
the professional community. We at VistaCare applaud this bill
for its commitment of monies for the advancement of
understanding of palliative care and for the education of
health care professionals in the principles and practice of
palliative care. This commitment of time and money to these
educational efforts will send a very clear message that the
U.S. Congress has taken up the cause of providing competent,
compassionate, and comprehensive palliative care for our
citizens who face life-threatening illness. This is an
extremely important action both in concrete and symbolic terms.
I extend to the sponsors of this bill my deepest gratitude for
such a commitment.
Passage of this bill will send a clear message that the
care of many of our nation's most vulnerable citizens, those
facing death, is a concern shared by all of us and rises above
partisan politics. This bill is good for Americans of all
political persuasions.
We must educate our nation and our nation's health care
providers in medical ethics, current law, and the principles
and practice of palliative care and the incredible holistic
work of hospice programs. This bill helps achieve this
necessary education.
It is imperative that we develop a strong national response
to oppose efforts to legalize assisted suicide and euthanasia
and this bill sends a strong message that our government does
not endorse the deliberate killing of patients. Passage of this
legislation strengthens hospice and palliative care and says
that our citizens, patients and physicians, need not resort to
suicide and killing to achieve comfort and relief from
distressing pain and symptoms.
I would urge you, members of this committee, and the entire
Congress of the United States to continue to work with the
hospice and palliative care communities to revolutionize the
practice of hospice and palliative medicine. Let us commit to
creating a comprehensive hospice and palliative care program
for all of our citizens. Let us forge a new path with the
Health Care Financing Administration and private insurance
companies to ensure that all patients receive the finest in
end-of-life care. Let us say to our citizens that no one must
ever turn intentionally and deliberately to causing death
because of pain, symptoms, or the effects of a terminal
illness.
Amended H.R. 2260 is an excellent step in the direction of
forging a system of care that embraces with true compassion
those who face terminal illness. Let this bill become not an
end to itself but the beginning of a national commitment to
caring for our citizens in the final stages of their lives.
As a hospice and palliative care physician, I endorse this
chairman's substitute. VistaCare Hospice, as a health care
company that serves the interests of terminally ill and dying
patients, believes that this chairman's substitute bill is
consistent with our mission and values and that our patients
will continue to receive state-of-the-art pain and symptom
management while affirming their inherent dignity. This bill is
an excellent beginning in providing the long overdue and too
often neglected component of hospice and palliative care in our
health care system as we enter this new century. Thank you for
allowing me to be here.
Senator Sessions. Thank you, Dr. Hunter.
[The prepared statement of Dr. Hunter follows:]
Prepared Statement of Walter R. Hunter, MD
Mr. Chairman, Members of the Committee, Ladies and Gentlemen: It is
a privilege to be here today and to offer you my thoughts on Chairman's
Substitute for House Resolution 2260. I am a full time hospice
physician with VistaCare Hospice, the second largest provider of
hospice services in the United States. I have testified previously in
favor of the Pain Relief Promotion Act and I return today to re-iterate
my support, particularly in view of the current amended version you are
now considering.
To briefly review my clinical background, I am certified in both
internal medicine and hospice and palliative medicine. I have worked
full time in hospice care for nearly four years. In that capacity, I
have been involved in cases in which the side effects of medications
may indeed contribute to the death of the patient. I have accepted
these side effects as undesired effects in the true goal of providing
pain and symptom relief. My use of controlled substances has always
been dictated by the clinical circumstances. As a hospice physician I
have never had any fear that my use of controlled substances could be
interpreted erroneously as deliberately and intentionally killing my
patients. I learned the clinical and ethical dimensions of palliative
care long ago and can state that the oft-quoted ethical Principle of
Double Effect is key and foundational to effective pain and symptom
management.
The Principle of Double Effect is with me daily. It guides my
actions as a physician and it keeps me honest in my actions. It is a
viable ethical principle and it is the basis of this legislation's
intent not to interfere with legitimate pain and symptom control.
Nothing in this bill will change what I do daily in my work as a
hospice physician. Nothing in this bill will diminish our work at
VistaCare to aggressively and adequately treat pain. Nothing in this
bill frightens me that I will become a ``target'' of the DEA in a
misguided attempt to prevent abuses of these controlled substances. Our
patients at VistaCare will continue to receive as much morphine and
other controlled substances as is necessary to control their pain and
symptoms. On the contrary, this bill has the real potential to enhance
our work in the communities we serve to promote palliative care, pain
and symptom management, and a vision of end-of-life care which we
believe is essential for our nation.
This bill has been accused by some in the medical community as
merely a back door effort to thwart the development of assisted suicide
and euthanasia for terminally ill patients. Some professionals have
complained that it will discourage physicians from providing adequate
pain relief for their patients because of fears of inappropriate
scrutiny of medical practice by the Drug Enforcement Administration
(DEA). Some believe it to be one more example of an intrusion by the
Federal Government into the privacy of the physician-patient
relationship and state jurisdiction over medical practice. I believe
all of these concerns to be overstated and unfounded but they have been
carefully examined by dedicated and knowledgable professionals. The
bill you have before you includes changes to address these concerns.
This legislation is, I believe, a timely, necessary, and explicit
clarification of the existing Controlled Substances Act. Current CSA
law does not allow for a physician to assist in suicide or to commit
euthanasia; there are defined penalties for physicians who engage in
diverting controlled drugs for non-medical uses and the Federal
government has never regarded physician-assisted suicide or euthanasia
as medical acts. However, Attorney General Janet Reno erred, in my
opinion, when she ruled that existing CSA law was somehow invalid in
Oregon just because Oregon has passed legislation allowing physician-
assisted suicide. The current situation, therefore, is that I would
face penalties for violation of the CSA if I practiced in 49 states and
engaged in physician-assisted suicide, but I would not be subject to
the same penalties if I lived in Oregon and committed the same act.
Ladies and Gentleman, I am no legal scholar, but I thought I learned in
grammar school that Federal law supercedes state law.
The legislation you have before you breaks no new legal ground. It
does not authorize any new penalties for errant physicians. It does not
grant the DEA any new powers for reviewing the use of controlled
substances. It does not provide any excuse for a physician to under
prescribe or fail to prescribe medications for pain and symptom relief.
It merely brings Oregon under the same regulations affecting the other
49 states.
The authors of this amended legislation have heard the concerns and
fears expressed in many arguments against this bill and have added
further language to this bill that should satisfy all of its legitimate
critics. This legislation clearly and definitely demarcates a line
which is essential to the principles and practice of hospice and
palliative care: It distinguishes philosophically and practically that
there is, indeed, a difference between the aggressive management of
symptoms even if death is an unfortunate outcome versus the deliberate
and single-minded intention of killing a patient. The codification of
the Principle of Double Effect in this legislation should be cause for
celebration in the medical community. It grants to physicians express
acknowledgement of the realities of the practice of pain and symptom
control. It is an express acknowledgement that it is not that hard to
distinguish the legitimate use of controlled substances for legitimate
medical reasons from the deliberate, intentional causation of death.
As an example of the work I am called to do daily, let me describe
a case of a young AIDS patient I cared for a few years ago. On a Monday
morning the hospice for whom I worked received a phone call from his
family that he was having difficulty breathing. His nurse and I made a
house call. When we entered the room we could hear his laborious and
moist respirations across the room. His respiratory rate was 44 and he
was unconscious. We immeditely set to work. I gave him 40 mg of Lasix
(furosemide) \1\ intravenously. There was no effect. I then gave him 10
mg of morphine \2\ intravenously. There was no effect after several
minutes. I repeated the dose of 10 mg of morphine and waited several
minutes. Again, there was no effect. I gave 5 mg of morphine. There was
still no effect. I then gave 5 mg of Valium (diazepam) in an attempt to
sedate him and ease the work of breathing. There was no effect. I
repeated the Valium dose and there was still no effect. I gave 5 mg of
morphine, waited, saw no effect and gave another 10 mg of morphine.
After a few minutes, his respirations decreased to about 20. This was a
reasonable goal. However, instead of stabilizing at 20, they continued
to diminish and he stopped breathing several minutes later.
---------------------------------------------------------------------------
\1\ A diuretic that helps rid the body of salt and water by
increasing excretion through the kidneys. This diuretic effect helps
mobilize fluid out of the lungs and should theoretically improve the
patient's breathing if fluid accumulation in the lungs is creating the
breathing difficulty.
\2\ Morphine is used in respiratory distress to ease the work of
breathing.
---------------------------------------------------------------------------
Did the fact that a respiratory rate of over 40 is terribly
inefficient and allows toxins to build up in the body that can suppress
respirations cause his death? Was he actively dying no matter what I
did? Did the medications play a role in hastening the moment of death?
Did I kill him? The answer is that the disease, his respiratory rate
and the medications all may have combined to cause his death to occur a
moment in time sooner than it would have occurred without my
intervention. But I did not intend his death. I was using everything in
my medical powers to ease the distress of his breathing. Had I
deliberately wished his death, I would have given the Lasix, 40 mg of
morphine and 10 mg of Valium as one immediate injection. Instead, I
titrated the medicine against the clinical response I saw over the
period of an hour. To apply the oft-quoted principle of Double Effect
and apply it to this case would be useful in this example.
The Rule of Double Effect makes the following assertions:
1. The Nature of the Act. The act must be good, or at least
morally neutral (independent of its consequences.)
2. The Agent's Intention. The agent intends only the good
effect. The bad effect can be foreseen, tolerated, and
permitted, but it must not be intended.\3\
---------------------------------------------------------------------------
\3\ For an excellent look at the Principle of Double Effect and the
role of intent, see Daniel Sulmasy, O.F.M., M.D., Ph. D., ``The Use and
Abuse of the Principle of Double Effect,'' Clinical Pulmonary Medicine,
Vol. 3, No. 2, March, 1996.
---------------------------------------------------------------------------
3. The Distinction Between Means and Effects. The bad effect
must not be a means to the good effect. If the good effect were
the direct causal result of the bad effect, the agent would
intend the bad effect in pursuit of the good effect.
4. Proportionality Between the Good Effect and the Bad
Effect. The good effect must outweigh the bad effect. The bad
effect is permissible only if a proportionate reason is present
that compensates for permitting the foreseen bad effect.\4\
---------------------------------------------------------------------------
\4\ Beauchamp, Tom L. and Childress, James F. Principles of
Biomedical Ethics, 4th Edition, Oxford University Press, New York,
1994.
---------------------------------------------------------------------------
Using the above, let us analyze my patient utilizing each criterion
from each perspective:
1. The Nature of the Act. The act (giving the patient the Lasix,
morphine and Valium for the purpose of alleviating his respiratory
distress) must be good, or at least morally neutral.
I would propose that his respiratory rate was too fast for any
effective air exchange. This alone increased his risk of death not to
mention how much discomfort it may have been causing him even though he
appeared to be unconscious.\5\ Certainly, his family was present and to
watch him gasp and labor for air was very difficult for them.
Therefore, the act of giving him the medicine was good from the
clinical perspective.
---------------------------------------------------------------------------
\5\ Interestingly, even though he was ``unconscious,'' his family
reported to me that when his two young nephews left the house earlier
that morning with their father, they said to him from the door of the
apartment, ``Good bye, Uncle Joe.'' The family noted that upon hearing
his name from the young boys he opened his eyes. In hospice work, we
are convinced that patients are often able to experience the presence
and hear the words of family and friends even though they (the
patients) cannot effectively communicate their experience.
---------------------------------------------------------------------------
2. The Agent's Intention. The agent (the physician--I, in this
case) intends only the good effect. (The alleviation of his labored
breathing.) The bad effect (possibly depressing his respirations or
even causing his breathing to stop as a result of side effects of the
medications) can be foreseen, tolerated, and permitted, but it must not
be intended.
I knew that there was a slight risk of lethal side effects to the
medications. But I knew that I might have to risk them, tolerate them
in part or in totality if I were to attempt to ease his breathing. I
did not intend for him to die, but I did intend to make his breathing
easier. Had I intended the side effect of cessation of breathing, I
would not have given incremental doses of medicine over time and
observed his clinical response with each dose. I would have given a
very large dose all at once to stop the breathing.\6\
---------------------------------------------------------------------------
\6\ Using the criteria of intent raised by Sulmasy in the article
referenced above (Reference 5), had the patient not died, I would have
felt relief and been happy. Additionally, by Sulmasy's criteria in
analyzing my intent, I would then have calculated a dose of medication
or combinations of medications based on my bedside work that morning
which would have been designed to keep his breathing as comfortable as
possible.
---------------------------------------------------------------------------
3. The Distinction Between Means and Effects. The bad effect (the
cessation of breathing) must not be a means to the good effect (ease in
breathing.) If the good effect (ease in breathing) were the direct
causal result of the bad effect, the agent would intend the bad effect
in pursuit of the good effect.
Clearly, not breathing is not merely easier breathing. I intended
only the effect of easing his breathing, not totally stopping his
breathing. I, therefore, did not intend the bad effect in order to get
the good effect.
4. Proportionality Between the Good Effect and the Bad Effect. The
good effect (ease of breathing) must outweigh the bad effect (possible
cessation of breathing as a side effect of medication.) The bad effect
is permissible only if a proportionate reason is present that
compensates for permitting the foreseen bad effect.
Unrelieved breathing at 44 times per minute without relief can
become fatal in and of itself. It is certainly uncomfortable for any
conscious individual as it is literally a sense of suffocation. The
risk of side effects of the medicine would be permissible to alleviate
the certainty of the discomfort and danger of his uncontrolled
respiratory rate of 44.
In short, the Principle of Double Effect guided me through the
decision making process and the actions I performed in this case.
Chairman's Substitute for H.R. 2260 recognizes what I did in this case
as legitimate palliative care, does not view my actions as assisting a
suicide or committing euthanasia, and therefore protects me from
prosecution for committing those acts.
This legislation establishes also that the United States government
stands firm in its commitment to ensure that patients receive the very
best there is available in palliative care but that the deliberate
killing of those patients is neither endorsed nor encouraged by the
United States government. It is not unreasonable for the Controlled
Substances Act to prohibit physician-assisted suicide or euthanasia as
a condition for maintaining a DEA license. All licenses carry certain
privileges and certain restrictions. It is disingenuous to believe a
DEA license should have no restraints.
In addition to all of these benefits, this legislation puts end-of-
life care, pain and symptom management, and the care of our citizens in
the spotlight at the center of the stage. While it certainly is not the
final word in a proactive response to the needs of our aging population
and dying patients, it is an important start. As we study our progress
in further developing hospice, palliative care, and pain treatment for
our citizenry, Congress will be called upon again to re-commit itself
in principle and practice to ensuring comfort for all people who face
serious or terminal illness. This legislation is a giant step toward
that commitment.
As a physician, I am ashamed to admit that the vast majority of our
nation's medical schools and residency programs have simply failed to
make medical ethics, pain and symptom management priorities in their
curricula. This information, however, is absolutely essential for
physicians to properly provide excellent care for patients. Physicians
can and must learn and understand thoroughly the Principle of Double
Effect, and how that principle is incorporated into the clinical
practice of palliative medicine and the intent of this legislation.
This legislation provides for much needed education in the professional
community. We at VistaCare applaud this bill for its commitment of
monies for the advancement of understanding of palliative care and for
the education of health care professionals in the principles and
practice of palliative care. This commitment of time and money to these
educational efforts will send a very clear message that the United
States Congress has taken up the cause of providing competent,
compassionate, and comprehensive palliative care for our citizens who
face life-threatening illness. This is an extremely important action
both in concrete and symbolic terms. I extend to the sponsors of this
bill my deepest gratitude for such a commitment. Passage of this bill
will send a clear message that the care of many of our nation's most
vulnerable citizens--those facing death--is a concern shared by all of
us and rises above partisan politics. This bill is good for Americans
of all political persuasions.
We must educate our nation and our nation's health care providers
in medical ethics, current law, and the principles and practice of
palliative care and the incredible holistic work of hospice programs.
This bill helps achieve this necessary education. It is imperative that
we develop a strong national response to oppose efforts to legalize
assisted suicide and euthanasia and this bill sends a strong message
that our government does not endorse the deliberate killing of
patients. Passage of this legislation strengthens hospice and
palliative care, and says that our citizens--patients and physicians--
need not resort to suicide and killing to achieve comfort and relief
from distressing pain and symptoms.
I would urge you, Mr. Chairman, members of this committee and the
entire Congress of the United States to continue to work with the
hospice and palliative care communities to revolutionize the practice
of hospice and palliative care in our nation. Let us commit to creating
a comprehensive hospice and palliative care program for our citizens.
Let us forge a new path with the Health Care Financing Administration
and private insurance companies to ensure that all patients receive the
finest in end-of-life care. Let us say to our citizens that no one must
ever turn intentionally and deliberately to causing death because of
pain, symptoms or the effects of a terminal illness. Chairman's
Substitute for H.R. 2260 is an excellent step in the direction of
forging a system of care that embraces with true compassion those who
face terminal illness. Let this bill become not an end to itself, but
the beginning of a national commitment to caring for our citizens in
the final stages of their lives.
As a hospice and palliative care physician, I endorse this
Chairman's Substitute for H.R. 2260. VistaCare Hospice, as a health
care company that serves the interests of terminally ill and dying
patients, believes that this Chairman's Substitute is consistent with
our mission and vision that patients receive state-of-the-art pain and
symptom management while affirming their inherent dignity. This bill is
an excellent beginning in providing the long overdue and too often
neglected component of hospice and palliative care in our health care
system as we enter the new century.
Thank you for allowing me to be here today.
Senator Sessions. Thank you to members of the panel. I
think it was an important dialogue that we have had and I look
forward to continuing it.
I think perhaps we all bring to this Senate when we are
elected our own values, beliefs, concepts about what is
important. Recently, an individual criticized me in the paper
by saying that Sessions had let his moral values interfere with
his good judgment. [Laughter.]
I do not know what that meant. A friend of mine wrote me a
letter and was rather amused by it. So I think we all bring
that here.
One of our leaders in this Senate, Senator Grassley, I will
turn to you at this time.
Senator Grassley. Thank you very much. I want to be up
front with all of you and tell you what you probably already
know, and that is that I am a cosponsor of Senator Nickles'
legislation, and I know it is a highly controversial piece of
legislation.
I would start with Dr. Chevlen and I would ask you to
respond to an argument that Dr. Caplan made that the Pain
Relief Promotion Act will have a chilling effect on physicians
treating patients for pain. I would like to have you comment in
light of your experiences in States that have passed similar
pieces of legislation to this one.
Dr. Chevlen. This question deserves an answer, Senator. The
question is, would passage of a PRPA bill, either nationally or
on a State level, deter physicians from prescribing adequate
pain relief medicine? Would it have a chilling effect?
This is a testable hypothesis and one which has been tested
in the laboratory of the States. There are six States which
have recently passed laws which are identical in impact to this
Federal law. In all of those States, we see that morphine
consumption actually increased. It did not decrease.
I have the graphs here, but it might be easier for people
to see if those were displayed. Now, this rising use of
morphine in States which have passed PRPA-type legislation does
not prove that passing PRPA legislation improves pain control.
What it does disprove, however, is that it worsens pain
control, and that was the issue before us.
The graph you see now is the morphine consumption per
capita in Iowa and how it rose after PRPA-type legislation was
passed there.
Senator Sessions. It looks from that chart that it more
than doubled since the passage in 1995 of the Act.
Dr. Chevlen. Yes, sir. Similar data are available for five
other States, but I think that makes the point.
Senator Grassley. Dr. Foley, I am going to ask you to be
kind of a referee here. We heard the argument from you that
this legislation would expand the authority of the Controlled
Substances Act, and yet, as you probably know, we have the AMA,
the Justice Department, and the National Hospice and Palliative
Care Organizations all concluding that the legislation would
actually reduce the authority of the Controlled Substances Act
over pain control and provide physicians with a clearer
protection from legal liability than existed before. How do you
suggest that we resolve those differences of opinion?
Dr. Foley. I think it matters on who you ask. There was a
survey in an attempt to address this issue in New York State to
look at how regulatory practices in New York State, these
strict regulations that we have, impacted physician practice.
Really, I think almost to my own amazement, was the fact that
physicians consistently under-prescribed pain medications to
patients with cancer and even further under-prescribed
prescriptions to patients with noncancer.
As much as the discussion here has focused on end-of-life
care, I really come here as an advocate for the patient with
pain at the continuum of their illness, and one of the major
problems in this country is not simply the under-treatment of
patients at the end of life but the under-treatment of patients
throughout the course of their illness. And one of the major
barriers has been a very strict regulatory environment.
The Controlled Substance Act very clearly now says that it
supports the use of these medications for legitimate medical
practices. I think that the issue here is not a legal issue but
it is much more of a medical issue of physicians who are
profoundly undereducated in the evaluation and treatment of
patients with pain and physicians who are profoundly
undereducated in palliative care. We have had so much data, and
the Institute of Medicine has summarized this for you.
So to pass a law that really is not addressing the problem
will not add anything, and my great concern is that it does,
every increased level of regulation, any possibility that the
Drug Enforcement Agency could be at the bedside of the patient,
has an impact on clinicians who are uneducated and untrained in
addressing the needs of patients in this area.
Senator Grassley. Thank you very much for your answer.
Dr. Hunter, you discussed the principle of double effect
and you used this principle to explain the underlying intent of
a physician's action. Is the principle of double effect part of
a standard medical school curricula? Is it something every
physician is expected to know and to understand?
Dr. Hunter. It was certainly not explicitly taught to me
when I was in medical school or residency training. I would,
without having the specific information available, I would go
out on a limb and say that, no, it is probably not being taught
explicitly in the vast majority of our schools. It is implied
in many things, and, in fact, it is implied in virtually
everything we do as a physician. It is just that physicians do
not recognize it as such.
To give a very, very clear example, if you were to come to
see me and I had an indication to give you penicillin and I
took a history and that you had no prior history of allergy to
penicillin and you went home and took the penicillin and you
suddenly had an anaphylactic reaction and died, I could invoke
double effect. I did not intend for that. That is a recognized
risk with the treatment, but the treatment is indicated. Now, I
would certainly be held liable had I failed to take a drug
history from you.
But I think physicians do not understand it and I think
that Dr. Foley is absolutely correct. We have an abysmal
situation in our medical schools and our residency programs. As
Dr. Foley has said, I think it does depend on whom you ask.
My recommendation for this is that every physician in this
country immediately be brought into the 21st century in pain
and symptom management. The tools are out there. The experts
are there, so that we just need to have a concentrated national
effort to get physicians to do the right things. I was grossly
undertrained in pain and symptom management and I was one of
those physicians under-treating patients until I did some
independent study and learned how to do this. I promise you, it
is not rocket science. If I can learn it, anyone can learn it.
Senator Grassley. Thank you. Thank you, Mr. Chairman.
Senator Sessions. Senator Wyden.
Senator Wyden. Thank you very much, Mr. Chairman. Again,
let me express my thanks to you.
I will start with you, if I could, Dr. Caplan. I got a fax
from the DEA that indicates to me that in the substitute that
will be voted on on Thursday in the committee, that the Federal
Government would be able to spend up to $80 million a year
investigating physicians for potential violations of this law.
The amount that the substitute sets aside for palliative care
is $5 million. So what the committee will vote on on Thursday
is a measure that, in effect, allows 16 times the resources to
be devoted to investigating physicians as we would have to
promote pain relief.
You have said the pain relief movement is very fragile in
this country. What message does the Senate send if it passes
that on Thursday?
Mr. Caplan. I think the message is loud and clear. To me,
the message will be heard as, avoid the threat of abuse of
addictive and risky pain control drugs. Do not take the relief
of pain as your top priority. And I think, ethically, what the
dying cannot often protect their own interest and families, who
are often, if you will, beside themselves because of the
emotional burden that befalls family members when they are
trying to care for the dying in an acute care setting, often
with unexpected illness, they cannot insist that pain take
priority. So the message will be the authorities are going to
keep an additional eye over your shoulder. Be cautious.
And I fear, given the fragile nature of what we are trying
to do to move medicine along to do what we all agree on this
panel must be done, make pain control, and suffering relief, I
might add, top priorities of care, that that will be inimical.
That budget allotment will be inimical to that laudatory goal.
Senator Wyden. Just a couple of others very briefly, Mr.
Chairman.
Dr. Foley, for you, if I might, you are a physician living
in rural Oregon, rural Iowa, rural Alabama. The under-treatment
of pain is already a documented public health crisis. The
Federal Government with the substitute now has the authority to
dissect a physician's intent with respect to their prescribing
practices. What is going to go through a doctor's mind when
they think about reaching for that prescription pad to write a
prescription not for anything to do with assisted suicide but
just for pain relief? What is going to go through that
physician's mind if this bill becomes law?
Dr. Foley. Well, whether the bill becomes law or not, what
goes through their minds now is--they are not educated in
caring for patients and the overwhelming strict regulatory
environment that we have had has made them very fearful of
prescribing drugs, and in Oregon, made them very fearful.
Oregon had very strict regulatory practices that only recently
have changed.
The physician is at the bedside trying to do the right
thing for the patient and has not been educated to do the right
thing for the patient. So I think more likely what we are
seeing is doctors do not have DEA licenses and what they say to
their patients is, I cannot treat your pain and I cannot
provide opioids because I do not have a DEA license, and that
is how they are getting around this issue.
Senator Wyden. One last question, Mr. Chairman. Another
significant difference in my mind, Dr. Caplan, between the
substitute, the measure I developed with Senator Mack and
Senator Smith and what will be voted on on Thursday, involves
families and including families in these difficult decisions.
We have in our bipartisan bill support for family support
networks that mobilize families for the first time in trying to
participate in these decisions, and I know all of you have seen
in your practice a family can be with a patient, say, on a
Sunday and the patient is in agony and they cannot get help for
the person. They call, and call back during normal business
hours.
So we want to, 24 hours a day, every day of the year, have
families in a position to get help for the suffering, and this
is a difference between the substitute and our legislation. I
wonder if you would just comment for a moment on the role of
families, empowering them as we look at this issue, Dr. Caplan.
Mr. Caplan. Well, I have been interested for a long time in
what happens at the end of life, and what we do in our country
is we tend to say that we will establish individual rights,
individual controls, and respect personal choice and autonomy
about managing one's dying. We usually add to that what we have
heard about a little bit, the commission and omission standard
as governing what the doctor can do. But we have established a
lot of authority over how ones dies, establishing the right to
withdraw treatment, forego treatment, withhold treatment.
What we have a harder time understanding is that when
people are dying, the family plays a crucial role because your
autonomy is diminishing and it is hard to assert that power
when you are impaired, when you become cognitively damaged, and
when you are just in emotional and spiritual turmoil as part of
the dying process. Some can do it, some cannot.
So it is absolutely crucial, and I think the lesson, if you
will, of the living will is you can fill out documents and say
what you wish, but if your family and those who love you are
not present and able to assert their authority and power when
you are dying, you will not have your wishes respected. The
family is the lever. It really is the tool that will make sure
that your wishes get respected, that what you want is going to
be acted on when you have a harder time expressing yourself.
So I absolutely support that emphasis. I think it is
crucial. Ironic as it may be, I think the road to individual
autonomy lies through creating empowerment for the people who
are present when that is somewhat jeopardized by serious
illness and fatal illness.
Senator Wyden. Thank you, Mr. Chairman.
Senator Sessions. Thank you, Senator.
Rabbi Bleich, in your experience and your best judgment, is
this a major issue for this culture? Is this a big deal
decision, whether or not we would give governmental imprimatur
to having physicians assist in the death of a patient?
Rabbi Bleich. In an age of declining emphasis upon moral
values, this is a major matter. It is a question of enunciating
public policy and through public policy public morals and
values. Allowing the Federal license to be used for
administering drugs designed to shorten life sends a very, very
significant moral message. It says that our Federal Government
does not recognize that as a matter which should be precluded
by law. In effect, it establishes a climate of opinion in which
there is an endorsement of that type of activity as reflective
of values and mores that are acceptable to the public at large.
I doubt very much, as I said before, that the passage of
the bill will prevent as much as a single suicide. It does have
a very significant effect not in how physicians will administer
these drugs, but it has a very significant effect upon the
moral climate of this country, and I think that that is a
matter of even graver importance.
Senator Sessions. In the history of a Judeo-Christian
culture and Western civilization, are you aware of any state-
authorized act by which suicide is justified or supported?
Would this be unusual in that regard?
Rabbi Bleich. It would be extremely unusual.
Senator Sessions. I know Oregon has voted on this bill, and
Rabbi, if it is a wrong, I am, as a prosecutor, Federal
prosecutor for 15 years, inclined to believe that Director
Constantine was correct in his analysis of the law. The
Attorney General saw otherwise, but I believe, my best
judgment, without pounding the table too hard, is that his
opinion was more correct legally. It strikes me that I have a
moral duty at this point. I cannot defer to Oregon, and neither
can any Senator here defer to Oregon. There is a Federal law
that either does prohibit this act or a bill pending before us
that would prohibit it. So in terms of denying responsibility,
would you say that it would be inappropriate for us to deny our
responsibility when we make a decision?
Rabbi Bleich. Let me say, Senator, that I fully agree with
you that as a matter of law, your interpretation of the statute
is correct and the Attorney General's is not. But
unfortunately, it is the Attorney General's interpretation of
the statute that has prevailed, so that to all intents and
purposes, the Act as it is now written and is now enforced is
the Act as interpreted by the Attorney General. In effect,
Congress is now being asked to substitute its understanding of
the original intent of the law for that of the Attorney
General.
And yes, I think that it would be a moral duty for anyone
in a position of authority, for anyone in a position to cast a
vote with regard to this Act, to vote and assert his authority
in a manner which would be consistent with public morality.
Senator Sessions. Dr. Chevlen, does this Act not explicitly
provide for pain relief treatment even if it were to shorten
life, and is that not a greater protection for the physicians
than they would now have under current law?
Dr. Chevlen. Senator, that is in the law by----
Senator Sessions. Here is the language. It says, ``For the
purposes of this Act, alleviating pain or discomfort in the
usual course of professional practice is a legitimate medical
purpose for the dispensing, distributing, or administering of a
controlled substance that is consistent with public health and
safety, even if the use of such a substance may increase the
risk of death.''
Dr. Chevlen. Senator, every day of my practice since I left
medical school, I have been practicing under that law because
that has been the law since the CSA was established, but it was
the law by administrative guideline. This bill before us
elevates that to the level of statute and actually decreases,
not increases, DEA oversight, or possible DEA oversight. By
raising the standard of proof necessary from the current level,
it actually makes it more difficult for the DEA to interfere,
not less difficult, and therefore should have an ameliorating
effect on a willingness of a doctor to use proper quantities of
proper medicine.
Senator Sessions. And would it give explicit statutory
protection to a physician who had, as Dr. Caplan mentioned, a
relative charging in at the last moment to complain? Would not
that physician feel somewhat more protected with this Act than
not?
Dr. Chevlen. It is certainly better than a regulatory
guideline.
Senator Sessions. I would just say this about the
dissecting of a doctor's intent or the suggestion that the DEA
would be at the patient's bedside. I think that is very
overdrawn and language that would not be correct. As an
attorney who prosecuted several physicians for deliberately
dealing in selling drugs illegally, I know how difficult it is
because a physician is given extraordinary discretion in what
they need to do to distribute drugs. I think if you had to have
a case under this Act, you would have to have evidence that
this physician knew that the amount of drugs he was prescribing
and giving would inevitably result in death in a short period
of time. That is just my basic view of it. And I think
physicians do not need to worry that the Federal Government and
the DEA is going to be in their prescribing rooms or in the
hospital rooms concerning this.
I would also point out that the American Medical
Association has supported this bill, which I do. The Medical
Association of the State of Alabama has written recently to me
that they are squarely opposed to--well, they say, ``The
Alabama Association and the American Medical Association are
squarely opposed to physician-assisted suicide and believe it
is antithetical to the role of a physician as healer,'' and
they go on to endorse this specific Act with the amendments
that are here.
So I believe we move forward in a way that has identified
our problems and the concerns that physicians have and tried to
address those, at least I am pleased that the sponsors of this
bill have, and I hope we are moving in that direction.
Senator Grassley, would you like another round?
Senator Grassley. I have no further questions.
Senator Sessions. Senator Wyden.
Senator Wyden. No.
Senator Sessions. Again, let me say how much I appreciate
your contribution to this discussion. I do believe this is a
matter of importance. It is not an itty-bitty thing, as Senator
Hatch is wont to say on occasion. It is a matter that we need
to take seriously. You have added immensely to our ability to
analyze it. I am supportive of this Act. I believe a majority
will be. Thank you.
If anyone has any questions, they may submit them for the
record, and we thank you all.
We are adjourned.
[Whereupon, at 11:20 a.m., the committee was adjourned.]
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Additional Submissions for the Record
----------
Hyman, Phelps & McNamara, P.C.,
Washington, DC, October 18, 1999.
James A. Guest,
Executive Director, American Pain Foundation,
Baltimore, MD.
Dear Mr. Guest: You have asked my opinion on the potential impact
of S. 1272, the ``Pain Relief Promotion Act of 1999'' (the ``PRPA''),
introduced by Senator Nickles and its companion bill H.R. 2260,
introduced by Representative Hyde, on the use of controlled substances
for palliative care. I have limited my opinion to an analysis of Title
I which amends section 303 of the Controlled Substances Act (CSA).
Also, this opinion is based on a review of the current law, DEA's
policy in regard to practitioner registrations and my experience as a
former attorney in the Drug Enforcement Administration's (DEA's) Office
of Chief Counsel.
The PRPA provides that a practitioner's dispensing, distributing or
administering of controlled substances to assist in suicide would be
against the public interest without regard to state law or medical
standards. The bill acknowledges that providing controlled substances
for palliative care, even if it hastens death, is legitimate medical
care. It defines such care, however, within the context of physician-
assisted suicide and judgments about a physician's intent.
Consequently, the bill inappropriately expands DEA authority to
evaluate the practice of medicine as it pertains to pain management.
DEA will be required to interpret a physician should be registered
under the Controlled Substances Act (CSA). The Department of Justice
and DEA have recently rejected such subjective decision making on the
part of the agency in issues related to pain management. The PRPA does
not improve the standards for palliative care and may make physicians
hesitant to prescribe controlled substances in treatment of severe pain
for fear of the potential criminal, civil and administrative penalties.
1. Current law and DEA regulations and policy already acknowledge that
prescribing controlled substances is appropriate in the
treatment of pain.
The relevant law and the courts recognize the legitimacy of
prescribing controlled substances for palliative care. The CSA and DEA
regulations provide that physicians have on obligation to treat those
suffering from intractable pain. The CSA states that many controlled
substances have a ``useful and legitimate medical purpose and are
necessary to maintain the health and general welfare of the American
people.'' 21 U.S.C. Sec. 801(1). In DEA's Physician's Manual, (March
1990) the agency asserts that:
[c]ontrolled substances and, in particular, narcotic
analgesics, may be used in the treatment of pain experienced by
a patient with a terminal illness or chronic disorder. These
drugs have a legitimate clinical use and the physician should
not hesitate to prescribe, dispense or administer them when
they are indicated for a legitimate medical purpose. It is the
position of the Drug Enforcement Administration that these
controlled substances should be prescribed, dispensed or
administered when there is a legitimate medical need.
DEA Physician's Manual at 21.
Even where the CSA requires a special registration for prescribing
of controlled substances for addiction treatment, DEA regulations state
that there is no intent to limit a physician's prescribing for
intractable pain. 21 C.F.F. Sec. 1306.07. The U.S. Supreme Court has
also recognized that patients suffering from a terminal illness have a
right to palliative care even if it hastens death. Glucksberg v.
Washington, 117 S.Ct 2258 (1997); Quill v. Vacco, 117 S.Ct 2293 (1997).
Therefore, there is no ambiguity in the law or DEA policy as to
whether prescribing controlled substances for pain management is
appropriate medical care, even in large doses where necessary. However,
the problem lies in the implementation.
2. The PRPA would contradict DOJ and DEA's findings that the agency
should defer to the medical community on the appropriate
standards for prescribing for palliative care.
There is no argument about the fact that DEA has the authority to
deny or revoke a practitioner's registration where the physician has
unlawfully prescribed controlled substances. DEA regulations require
that physicians only issue prescriptions for a legitimate medical
purpose and in the usual course of professional practice. 21 C.F.R.
Sec. 1306.05. In addition, DEA can deny or revoke a registration where
a physician fails to follow either federal or state regulations on
either substantive or procedural (i.e., recordkeeping) requirements for
prescribing of controlled substances. (See e.g., Robert L. Dougherty,
Jr., M.D., 60 Fed. Reg. 55047 (1995); Harland J. Borcherding, D.O., 60
Fed. Reg. 28796 (1995)) DEA registrants can also be criminally
prosecuted where ``their activities fall outside the course of
professional practice.'' United States v. Moore, 423 U.S. 122 (1975).
In fulfilling these responsibilities, DEA has determined in several
recent cases that the agency should not make subjective decisions on
appropriate prescribing for pain management.
In 1995, DEA issued two final orders (Skinner & Roth) involving the
investigations of two physicians for inappropriately prescribing
opioids to the same patient for intractable pain. 60 Fed. Reg. 62262
(Dec. 5, 1995); 60 Fed. Reg. 62887 (Dec. 7, 1995). DEA investigators
alleged that the physicians inappropriately prescribed excessive
quantities of controlled substances for no legitimate medical purpose.
It was further alleged that the physicians inappropriately prescribed
them to a narcotic dependent person to maintain or detoxify the
patient. The patient, who had several legitimate medical conditions
that caused acute and chronic pain, ultimately was admitted to the
Betty Ford Clinic with a diagnosis of dependency on opiates, alcohol,
sedatives and amphetamines.
A hearing was conducted on the revocation of these physicians' DEA
registrations.
The physicians presented expert testimony demonstrating that they
had followed state guidelines on prescribing for chronic pain and that
the prescribing was appropriate. The administrative Law Judge (AlJ) who
heard the cases recommended against revocation of their registrations.
The DEA Deputy Administrator ultimately agreed with the ALJ and did not
revoke the registrations. Significantly, the Deputy Administrator
concluded that:
The conflicting expert opinion evidence presented leads to the
conclusion that the medical community has not reached a
consensus as to the appropriate level of prescribing of
controlled substances in the treatment of chronic pain
patients. Given this dispute, the Deputy Administrator is
reluctant to conclude that the Respondent's prescribing of
controlled substances to Patient A lacked a legitimate medical
purpose or was outside the usual course of professional
practice. It remains the role of the treating physician to make
medical treatment decisions consistent with a medical standard
of care and the dictates of Federal and State law.
60 Fed. Reg. at 62267, 62891.
More recently, the agency reiterated that it would be inappropriate
for DEA officials to impose their subjective definition for legitimate
medical care in the context of pain management. At issue in the case of
Paul W. Saxton, M.D. 64 Fed. Reg. 25, 073 (May 10, 1999).), were 38
medical records for patients treated for chronic pain. A pharmacist
complained to the State Board because the physician had prescribed six
different controlled substances to one individual. DEA and state
investigators seized 38 patient records as a result of a review of the
physician's prescription profiles from several local pharmacies.
Both the government and the physician provided expert testimony at
the hearing. In ruling for the physician, the DEA Deputy Administrator
found that the prescriptions were justified based on several factors,
including a review of the patient charts, testimony from the physician,
patients and experts, and reports from specialists. The DEA also found
that the experts had all testified that there is no upper limit on the
use of narcotics in the treatment of chronic pain. The Deputy
Administrator rejected the government's argument that the physician
should have reduced the dosage levels. Both the ALJ and DEA Deputy
Administrator concluded that:
It is apparent that there is a disagreement within the medical
community regarding the use of controlled substances in the
treatment of chronic pain. . . . DEA is in a difficult
position, for it is asked to determine the appropriate
prescribing practices in the treatment area in which the
medical profession is not in accord: the treatment of chronic
pain patients. . . . [It] is not DEA's role to resolve this
disagreement. It remains the role of the treating physician to
make medical treatment decisions consistent with a medical
standard of care and the dictates of the Federal and State law.
Saxton at 25,079 (emphasis added).
The PRPA contradicts DEA's policy that the agency should defer to
the medical community on the appropriate standards for prescribing for
pain. By attempting to define ``legitimate medical purpose,'' the PRPA
would expand the DEA's authority to question a physician's decision in
prescribing controlled substances, even when it is within state medical
guidelines. This would logically include closer scrutiny by federal
investigators of decisions by physicians to prescribe and administer
pain medication, particularly when these decisions increase the risk of
death. Yet DEA has repeatedly asserted that it is not qualified to make
such decisions. The fact that the PRPA would authorize federal
authorities to promulgate rules for palliative care would attempt to
establish a federal medical standard. This would create further
conflicts especially because many states have already adopted
legislative standards for intractable pain. Given that establishing
medical standards has been left to the states and is regulated by the
states, DEA should not now begin to impose a separate medical standard.
3. The PRPA will increase DEA scrutiny of physician's palliative care.
The PRPA would establish a federal criteria for ``legitimate
medical purpose'' under the CSA, that is, the use of controlled
substances for alleviating pain or discomfort even if it increases the
risk of death. This is a departure from current law that would defer to
state medical standards and could create a conflict with state medical
guidelines as to the appropriate standard of medical care. The PRPA
attempts to determine what is and what is not a legitimate medical
purpose in the context of prescribing controlled substances for pain
but leaves to DEA the decision to determine the intent of a physician's
action. This would establish a dangerous precedent for the DEA to
dictate whether certain medical care is a ``legitimate medical
purpose'' where state authorities have determined otherwise.
Writing this standard into the CSA creates an obligation for DEA to
investigate and question the intent of physicians in prescribing
controlled substances for pain management. The result will necessarily
be an increase in DEA scrutiny of physicians treating patients for
severe pain where death has occurred. Physicians will be concerned that
DEA investigators will see criminal intent where there is none.
4. Practitioners will incur the costs and burden of justifying their
medical care to federal authorities.
The increased scrutiny by DEA as a result of the PRPA will require
physicians to incur costs to justify their prescribing of controlled
substances. These costs can be significant in the context of a criminal
or civil investigation or even in the context of a DEA administrative
proceeding on the denial of a DEA registration. Such costs include
hiring counsel and experts to defend a potential licensing proceeding
on prescribing of controlled substances. The record reflects that in
the Saxton case, the physician hired at least two experts and that the
administrative hearing lasted for 12 days.
5. Congress should not link palliative care with physician assisted
suicide in the context of the CSA public interest standard.
In juxtaposing the issue of palliative care which may result in
death with physician-assisted suicide, the PRPA makes it more likely
that physicians will come under increased scrutiny as to their intent
on prescribing large doses of narcotic drugs for palliative care.
Moreover, focusing this debate within the context of whether a
practitioner's DEA registration is in the public interest increases the
change that physicians will be hesitant to treat patients aggressively
for severe pain. Physicians will fear a potential flood of complaints
directed to federal authorities as to whether they have met an
appropriate standard of care. Physician-assisted suicide involves broad
policy issues beyond the determination of whether a physician is
qualified to prescribe controlled substances.
In conclusion, the PRPA will in fact not create new protections for
the treatment of pain nor does the CSA need to be changed to protect
practitioners. What is needed is appropriate implementation of existing
policies. The PRPA does not accomplish this. On the contrary it may
raise new barriers by expanding DEA authority to investigate and
question the intent of physicians and the practice of medicine as it
applies to palliative care, a result clearly not intended by the CSA or
established DEA policy. Under the PRPA physicians would be hesitant to
prescribe large doses of pain medication, particularly where death may
result in the short or long term, because of the potential for
criminal, civil or even administrative sanctions. This will contribute
to the continued problem of undertreatment of pain.
If it is Congress's intent to prohibit physician-assisted suicide,
it should do so with legislation directed at providing criminal
penalties for this activity rather than to limit the public interest
criteria under the CSA and thereby negatively affect the prescribing of
controlled substances for the legitimate treatment of pain. The
sections in Title I of the bill dealing with palliative care should be
removed in order to avoid the unintended effect of limiting patient
care. The issue of palliative care would be better dealt with in
comprehensive legislation such as the ``The Conquering Pain Act,'' (S.
941 and H.R. 2188) or other legislation that truly promotes treatment
of pain.
Sincerely,
John A. Gilbert, Jr.
__________
Harvard Law School,
Cambridge, MA, April 10, 2000.
Re H.R. 2260, the Pain Relief Promotion Act of 1999.
Hon. Edward Kennedy,
315 Russell Senate Office Building, Washington, DC.
Dear Senator Kennedy: We are writing to you to urge your continued
opposition to H.R. 2260, the Pain Relief Promotion Act of 1999. We are,
respectively, a professor of criminal law and former Dean at Harvard
Law School, a professor of health law and constitutional law at Boston
College Law School, and a Boston attorney who formerly represented the
Massachusetts Board of Registration in Medicine as an Assistant
Attorney General. After having had an opportunity to review Senator
Hatch's substitute bill, we have concluded that the substitution
represents, if anything, a greater threat than the original to the
effort to improve delivery of palliative care to patients who presently
suffer unrelieved pain.
Senator Hatch's substitute bill doubles the size of the original
H.R. 2260 by adding to it some hastily put together jurisdictional and
procedural provisions that exacerbate the bill's potential for
frightening physicians into undertreating pain. The most egregious of
these provisions is the section dealing with ``Burden of Proof.''
Whereas the previous bill spoke in terms of disciplining physicians who
dispense controlled substances with ``the purpose of causing death or
assisting another person in causing death,'' the new bill states that
the Attorney General need only prove that a physician's intent was to
dispense such a substance with ``a purpose of causing, or assisting in
causing'' death. Thus, while purporting to place a heavier burden of
proof on the Attorney General (``clear and convincing evidence'' rather
than ``a preponderance of the evidence''), the substitute bill actually
lowers the burden of proof. The Attorney General need no longer claim
that causing death was the predominant motive in prescribing a
controlled substance. She may initiate an investigation and prosecute a
physician if she merely suspects that it was among the motives. Perhaps
Senator Hatch did not intend to lower the burden of proof in this
fashion. But, if so, the fact that the change was made without
foreseeing its impact is at the very least evidence of the careless
haste with which amendments have been made to this bill in a last-
minute effort to save it.
Morever, raising the standard of proof from ``preponderance of the
evidence'' to ``clear and convincing evidence'' will not mitigate the
deleterious impact of this proposed legislation. Under H.R. 2260,
determining whether an act is one of high professional competence, on
the one hand, or murder, on the other, hinges upon whether a prosecutor
can prove after the fact that the secret intentions of a physician were
not merely to suppress pain but also to cause death. This is not the
typical case where an accused's intention is made an element of a
crime. In the typical situation, it is clear on the basis of objective
fact that a harm has been done and the only question is the degree of
responsibility of the actor who has caused the harm. Even in such
cases, there is a trend evident in civilized legal systems to move away
from dependence upon proof of subjective mental elements. As Judge
Posner points out: ``[W]e cannot peer into people's minds, as least not
with the clumsy tools of legal procedure, and if we could we are not at
all sure that we would find the intentions, malice, premeditation, or
other entities that the mentalist language of law invites us to
expect.'' \1\ In 1996, when the Supreme Court of the United States was
urged to weigh evidence as to the subjective intentions of policy
officers in determining whether search and seizure rights of suspects
had been violated, that approach was unanimously rejected by the Court.
``Subjective intent alone,'' said Justice Scalia for the Court, ``does
not make otherwise lawful conduct illegal or unconstitutional.'' \2\
---------------------------------------------------------------------------
\1\ Richard A. Posner, The Problems of Jurisprudence (1977) at 177.
\2\ Whren v. United States, 517 U.S. 806, 813 (1996), quoting from
Scott v. United States, 436 U.S. 128, 138 (1978).
---------------------------------------------------------------------------
In Addington v. Texas the Supreme Court said of the ``clear and
convincing evidence'' standard: ``[T]he ultimate truth as to how the
standards of proof affect decisionmaking may well be unknowable, given
that factfinding is a process shared by countless thousands of
individuals throughout the country. We probably can assume no more than
that the difference between a preponderance of the evidence and proof
beyond a reasonable doubt probably is better understood than either of
them in relation to the intermediate standard of clear and convincing
evidence.'' \3\ Whatever difference the higher level of proof might
make in other circumstances, it is likely to make very little
difference in this context. When we are speaking of physicians'
intentions, we are dealing with an internal mental event that will not,
in the ordinary case, be amenable to any sort of objective proof.
Although, in the end, the Attorney may have no easier time proving what
went on in a physician's mind than a physician would have disproving
it, the fact that H.R. 2260 makes every physician vulnerable to
investigation and prosecution whenever he prescribes controlled
substances to a dying patient will undoubtedly have a chilling effect
on his willingness to effectively treat pain.
---------------------------------------------------------------------------
\3\ 441 U.S. 418, 424-425 (1979).
---------------------------------------------------------------------------
Compounding the potential negative impact of this bill is the
influence it is likely to have on the behavior of actors other than the
Attorney General. Although Senator Hatch's substitute bill provides
that ``[n]othing in this subsection shall be construed to alter the
roles of the Federal and State governments in regulating the practice
of medicine,'' this language cannot prevent state actors and private
actors from adopting the standards promulgated by the bill for use in
other contexts. Once they are employed on a national level as a basis
upon which to withdraw DEA licensure, they are likely to be adopted by
state boards of registration as standards for disciplining physicians,
by district attorneys as standards for determining when to bring
prosecutions, and by plaintiffs' counsel as a basis for making claims
for medical malpractice.
Please let us know if we can provide you with any further
information.
Respectfully yours,
James Vorenberg,
Roscoe Pound Professor of
Law, Harvard Law School.
Charles H. Baron,
Professor of Law, Boston
College Law School.
Garrick F. Cole, Esq.,
Smith & Duggan, LLP.
__________
Johns Hopkins Medicine,
Department of Neurosurgery,
Baltimore, MD, February 21, 2000.
Dear Senator: We are opposed to the Pain Relief Promotion Act of
1999 (S. 1272/H.R. 2260) because it will be harmful to patients who
suffer from pain. We ask that you oppose the bill and work for
legislation that will, indeed, effectively promote pain relief.
As physicians who treat patients regularly for serious pain and
other debilitating symptoms, we support urgently needed improvements in
pain and symptom management. Based on our experience working with
patients and knowing the barriers to effective pain relief, we oppose
the Pain Relief Promotion Act as well-intended but against the
interests of the millions of Americans who suffer from pain. We urge
that you instead support legislation that addresses the real problems
in our health care system that block access to high quality pain and
symptom management and palliative care.
Our current system already chills effective use of pain
medications. Physicians' fear of investigation, their misunderstandings
about opioids because of lack of training, and the tangle of federal
and state regulations far too often delay or prevent pain relief that
is medically available. The Pain Relief Promotion Act fails to address
these issues in a way that will result in positive change.
Amending the Controlled Substances Act to say it is appropriate to
use drugs for pain relief even if that use may increase the risk of
death is unnecessary. This is already well-established policy at the
Drug Enforcement Administration. The bill's threat of DEA investigators
second-guessing a physician's ``intent'' in medical decisions, however,
will deter many practitioners from aggressive treatment of pain and
cause needless suffering by patients.
We urge that you avoid the slippery slope of trying to write
standards of medical care into federal statute--especially in the areas
of pain and symptom management and palliative care affecting so many
older Americans who in most cases are already undertreated for pain.
What is really needed is for Congress to address the tangle of federal
and state requirements and barriers concerning the use of controlled
substances that confuse and hamper pain management.
We recommend that Congress hold hearings and develop legislation
that would truly address the problems of undertreatment and
mistreatment of pain, including initiatives to cover not just pain care
at the end-of-life but the very serious public health problem of
chronic pain whenever it occurs.
If Congress is serious about promoting good pain management and
palliative care, we urge that you oppose the Pain Relief Promotion Act
and instead enact provisions that implement a comprehensive approach to
pain management and palliative care along the lines, for example, of
the Institute of Medicine's report in 1997 on Improving Care at the End
of Life.
It would be the utmost of cynicism to turn patients with pain into
political pawns by wrapping their medical care into the debate on
physician-assisted suicide. For the sake of patients, Congress should
not tamper with the Controlled Substances Act. Don't turn the War on
Drugs into a War on Patients.
Again, we implore you to reject the Pain Relief Promotion Act and
develop a comprehensive approach to pain and symptom management and
palliative care that provides real solutions rather than another layer
of fear.
Sincerely,
James N. Campbell, MD,
Professor of Neurosurgery
and Director of
Blaustein Pain Treatment
Center, Johns Hopkins
Medical Center,
Baltimore, MD.
Kathleen Foley, MD,
Attending Neurologist,
Memorial Sloan-Kettering
Cancer Center, New York,
NY.
Nelson Hendler, MD, MS,
Founder and Clinical
Director, Mensana
Clinic, Stevenson, MD.
Martin Grabois, MD,
Professor and Chairman,
Department of Physical
Medicine and
Rehabilitation, Baylor
College of Medicine,
Houston, TX.
Pamela Sutton, MD,
Director of Palliative Care
Services, Broward
General Cancer Center,
Ft. Lauderdale, FL.
__________
Brown University School of Medicine,
Dept. of Molecular Pharmacology, Physiology &
Biotechnology,
Providence, RI, April 21, 2000.
Senator Orrin Hatch,
Chairman of the Senate Judiciary Committee, U.S. Senate, Washington,
DC.
Dear Senator Hatch: I am writing in the strongest possible terms to
endorse your revised version of H.R. 2260, the Pain Relief Promotion
Act, scheduled for a committee vote on April 27. Please accept this
letter as a written submission for your April 25 hearing on the
legislation.
As a medical educator for the past thirty five years, a founding
member of the Rhode Island Cancer Pain Initiative, and a founding
member of Americans for Integrity in Palliative Care, I respectfully
request your support of the revised version of H.R. 2260 entitled the
Pain Relief Promotion Act. This enlightened piece of legislation is
supported by the American Medical Association, the National Hospice
Association, the American Academy of Pain Management, Americans for
Integrity in Palliative Care, and Physicians for Compassionate Care.
The passage of the Pain Relief Promotion Act will have an enormous
impact on the palliative treatment for the terminally ill. In the last
decade, medical care for persons at the end of life and for those who
experience severe, chronic pain has evolved dramatically. However,
despite the advances of modern day medicine in our country, there is a
lack of support and proper treatment of people with terminal illnesses.
Even physicians are unaware of and incredulous of the high success rate
of recent advances in the appropriate use of pain-relieving drug
regimens for the control of chronic, severe pain in terminal patients.
This legislation would provide the necessary resources and
educational efforts within both the public and private sectors to
intensify the availability of palliative treatment that addresses the
physical, psychological, and social distress that accompany terminal
illness and intractable pain. The Pain Relief Promotion Act would
provide the incentive to correct the following deficits: (1) that most
practicing physicians have not been trained in modern day chronic pain
management regimens, (2) that most practicing physicians have limited
experience in palliative care, and (3) that medical schools do not
include formal instruction in palliative care theory and application.
Your support of the Pain Relief Promotion Act will guarantee that
patients will receive proper treatment they need in order to face the
final stage of their life in dignity and comfort. In the states which
have passed laws similar to the Pain Relief Promotion Act, there has
been a definite and steady upward trend in the per capital use of
morphine for pain relief in palliative care.
I urge you to support and move the Pain Relief Promotion Act--H.R.
2260--as revised to the floor of the Senate for a vote.
Respectfully,
Ralph P. Miech, M.D., Ph.D.,
Associate Professor (Emeritus).
__________
Hunt Valley, MD, April 20, 2000.
To: The Senate Judiciary Committee.
From: Robert M. Sparks.
Subject: Comments on Senate Bill 1272.
As a resident of a retirement community for the past fourteen
years, I applaud the major objectives of S. 1272. They include:
education and training programs for providers in the use of controlled
substances in palliative care; development of programs for research and
palliative care policy; and provisions for the evaluation of these
programs. These are all worthy goals and I believe the 97 per cent of
the bill concentrating on them should be passed and funded.
Unfortunately the remainder of the bill, consisting of seven lines
(paragraph (2) at the bottom of page 2 of the bill and paragraph (3) at
the top of page 3) contribute nothing toward the attainment of the
bill's major goals. They merely deny the people of one state the right
to make a democratically determined decision, a right which the Supreme
Court has ruled, belongs to the states. At least one other state is
also considering similar action to afford individuals the right to the
kind of life exit they desire. This will would also lay the groundwork
for reversing the laws of many states which allow the elderly to make
decisions involving the withholding of certain types of treatment to
ensure death with dignity.
Although I am currently neutral on the issue of assisted suicide, I
urge you to accept the guidance of the Supreme Court on that issue. To
do otherwise would open the door to a future possibility that the
advance directives I have submitted to the administrators of Broadmead
Retirement Community, where I live, could be annulled. These directives
are designed to hasten death when I deem it imminent, a condition close
to that addressed by the paragraphs cited here, a right provided by the
laws of Maryland.
Robert M. Sparks.
__________
Statement of the American Nurses Association
The American Nurses Association is pleased to have the opportunity
to address H.R. 2260, the Pain Relief Promotion Act, which is under
consideration by the Committee on the Judiciary. The American Nurses
Association is the only full-service professional organization
representing the nation's registered nurses through its 53 constituent
associations.
ANA has been actively involved in efforts to prohibit assisted
suicide and continues to hold a strong commitment to the principle that
the role of medical and nursing professionals must be to heal and
relieve those in pain but not to act to end a life or to make the means
of death available to a person who seeks to end his or her own life.
However, ANA is concerned that provisions of H.R. 2260, even if
amended by the proposed substitute to be offered by Senator Hatch,
would have a chilling effect on pain management and result in needless
suffering, a result that is totally at odds with the professional
commitment of the nursing profession. Investigations by the Drug
Enforcement Administration, using the ambiguous standard of the
intentions of the health care professionals involved in the
prescription of medication, would be intimidating and
counterproductive. H.R. 2260, in making effective pain and symptom
relief more difficult to obtain, is likely to increase, rather than
decrease demands for assisted suicide. Furthermore, it would do nothing
to address assisted suicide by means other than controlled substances.
Nurses have long been in the forefront as leaders and advocates for
the delivery of dignified and humane end-of-life care and obligated to
provide relief of suffering and comfort to a dying person.
Participation in assisted suicide is not acceptable under the ethical
mandates of the profession, but neither should the legal system erect
barriers to appropriate palliative care, which is also an ethical
mandate for the profession.
ANA believes the Pain Relief Promotion Act would erect a tragic
barrier to appropriate palliative care and is ethically bound to oppose
it. ANA appreciates the Committee's consideration of these comments on
this issue and urges member of the Committee to oppose this
legislation.
Question may be addressed to Stephanie Reed, Associate Director of
ANA Government Affairs, 202-651-7088.
__________
Prepared Statement of James A. Guest, Executive Director, American Pain
Foundation
We commend the Judiciary Committee for holding hearings on the Pain
Relief Promotion Act (H.R. 2260) and the Hatch Substitute Amendment,
and we appreciate Chairman Hatch's attempt to take a bill that we feel
will be harmful to effective pain management and make it less harmful.
The changes in the Hatch Substitute are in most instances a step in the
right direction. But in our opinion both versions of the Pain Relief
Promotion Act are seriously flawed, and we oppose H.R. 2260, including
the Hatch Substitute, because the legislation is likely to have a
chilling impact on effective pain management and does not adequately
promote pain relief.
The American Pain Foundation is an independent, nonprofit
information, education and advocacy organization serving people with
pain. Our mission is to improve the quality of life for people with
pain by raising public awareness, providing practical information,
promoting research, and advocating to remove barriers and increase
access to effective pain management.
The Pain Relief Promotion Act and the Hatch Substitute are, in our
view, well-intended but misguided legislation that threatens to hinder
rather than help the treatment and care of people who suffer from
serious pain, especially near the end of life. The threat of DEA
investigators second-guessing their ``intent'' in medical decisions
will most likely deter many physicians and other practitioners from
aggressive treatment of pain and cause needless suffering by patients.
Ironically, because of the deterrent effect on using opioids, the bill
will almost surely increase rather than decrease the incidence of
suicide, assisted and otherwise, by those who can no longer tolerate
the agony of pain.
We are deeply concerned that if the bill passes physicians will be
even more reluctant than they already are to use aggressive medication
to treat patients suffering severe pain--even if they judge it to be
medically appropriate--and that therefore many more Americans will live
and die in pain. We believe the Drug Enforcement Administration should
continue to be a law enforcement agency fighting the illegal diversion
of drugs. It should not be turned into a medical oversight body--a task
for which it is inappropriate and unsuited. Yet this legislation has
the potential for just that result.
Pain--A Major Public Health Crisis
The proposed legislation comes at a time when pain is already
greatly undertreated because, in part, conscientious physicians and
other healthcare professionals fear investigation and sanctions by
regulatory bodies for aggressively managing their patients' pain.
Unrelieved pain--cancer pain, non-malignant chronic pain, and acute
pain--is a major public health problem in the United States.
Over 50 million Americans suffer from chronic pain, and each
year nearly 25 million people have acute pain as a result of injury
or surgery. Yet only 1 in 4 Americans receives proper treatment for
their pain.
Pain costs an estimated $100 billion each year including
medical expenses, lost income, and forced absence from work. Lost
workdays resulting from pain add up to over 50 million a year.
For most types of pain, there are safe, effective treatments
available that can alleviate or relieve the pain. According to the
federal Agency of Healthcare Research and Quality, for example, 90%
of cancer pain can be relieved through relatively simple means. Yet
fewer than half of cancer patients receive adequate treatment for
their pain.
In a large survey of oncologists, 86% of respondents felt the
majority of patients with pain were undermedicated. Another major
national study found that in the their last days of life, more than
half of hospitalized patients had unrelieved pain.
Finally, unrelieved pain is devastating to individuals and
families. When serious pain persists it permeates the patient's
entire life, making it difficult to concentrate and perform even
routine tasks. One of the most common reasons people cite for
supporting Dr. Jack Kevorkian's controversial views on physician-
assisted suicide is fear of intractable pain. Pain is a major
reason patients ask their doctors to help them die.
There is an overwhelming need for Congress to effectively address
the public health problem of unrelieved pain. But the Pain Relief
Promotion Act, including the Hatch Substitute, does not. It is a bill
aimed primarily at physician-assisted suicide, and it does so by using
the vehicle of the Controlled Substances Act (CSA) and adding in some
modest provisions relating to pain relief. The CSA amendments run the
risk of a detremental effect on the aggressive and medically
appropriate use of opioids for pain management while the provisions
pertaining directly to pain relief are minimal and inadequate.
A Real Agenda for Pain Relief Promotion
We agree with the broader scope of coverage in the Hatch Substitute
so that Title I covers not just ``palliative care,'' which is only one
aspect of pain relief, but ``pain management'' as well. The problem is
that the initiatives proposed in H.R. 2260 and the Hatch Substitute are
insufficient to make any significant progress in promoting palliative
care and pain management.
For example, the bill authorizes only $5 million for education and
training of physicians and other healthcare providers in pain medicine
and palliative care--an amount equal to less than 10 cents a person for
the over 50 million Americans who suffer from chronic pain--when this
need has been consistently cited as badly needed and long overdue. The
bill provides no additional funding for research.
Regarding protocols and evidence-based practices, the greater need
is not distribution of protocols and practices, although that will be
important later on, but support for the medical community to develop
more protocols on pain management and palliative care in the first
place. The proposed ``Decade of Pain Control and Research'' is a good
idea, and we applaud Senator Hatch for proposing it. But there are no
substantive programs attached to this one-sentence declaration of the
``Decade of Pain Control and Research,'' and it needs to be filled in.
We recommend that a true Pain Relief Promotion Act include a number
of important initiatives such as the following:
Education and Training. Require that all medical, osteopathic,
chiropractic, nursing, physical and rehabilitative medicine, and
other professional schools for direct care providers that receive
federal funding provide comprehensive education and training in
pain management.
Fifth Vital Sign. Require that in all federal healthcare
programs (in addition to the Veterans Administration, which has
already started doing it) and in programs receiving federal monies,
pain must be assessed in all patients as the ``fifth vital sign''
and be documented in a prominent place in the patient record.
Medicare and Medicaid Coverage. Require that Medicare and
Medicaid provide access to and pay for coverage of pain prevention
and treatment services and medications used in the management of
pain--including removing the Medicare restriction that denies
coverage for self-administered pain medication.
Patient Self Determination Act. Amend the Patient Self
Determination Act to require that all patients admitted to
federally funded health care facilities be informed of their right
to adequate pain control.
Underserved Populations. Require that in order for a
healthcare organization or provider to receive federal funding or
reimbursement of any kind, pain must be adequately assessed and
managed in all underserved populations including but not limited to
minorities, the young, the elderly and women.
Pain Relief Hotlines. Establish two national toll-free ``Pain
Relief Hotlines'' to answer questions and provide information about
pain management--one for medical professionals and one for people
with pain and their caregivers.
White House Commission. Establish a White House Commission on
Pain Control and Research to increase awareness, understanding and
aggressive action to remove barriers and increase access to
effective pain management.
Center or Advisory Panel at NIH. Establish a Center for Pain
Research at the Institutes of Health (NIH)--or, at a minimum,
establish an External Advisory Board on Pain Medicine at NIH,
analogous to the External Advisory Board on Cancer.
Policy Board at National Institute of Medicine. Establish a
National Pain Management and Palliative Care Policy Board at the
National Academies of Science's Institute of Medicine, analogous to
the IOM's National Cancer Policy Board.
Basic and Clinical Research and Outcomes-based Guidelines.
Increase federal funding for basic and clinical research on pain,
and appropriate funds for outcome-based research and development of
guidelines for treating different kinds of chronic and acute pain
and delivery of pain management services.
Surgeon General Report. Require the Surgeon General to prepare
and submit a report concerning the state of pain management in the
United States to the appropriate committees of Congress and the
public.
Flaws in Amending the Controlled Substances Act as a Way To Ban
Assisted Suicide and Euthanasia
If Congress wants to pass federal legislation prohibiting
physician-assisted suicide, it should pass a separate criminal statute
to ban it. We see a number of problems, however, with addressing
physician-assisted suicide by tampering with the Controlled Substances
Act.
Both the original Pain Relief Promotion and the Hatch
Substitute will likely cause harm to patients who need pain care by
threatening physicians and other healthcare professionals who
provide it. The legislation would give DEA agents the explicit
authority--with the urgency of being written into federal statute--
to question the intent of any physician or medical practitioner who
provided a controlled substance to a patient who died shortly
thereafter. A physician could lose the right to practice medicine
and be imprisoned for at least 20 years (the same punishment a drug
dealer would receive). This would make doctors more hesitant than
they already are to prescribe pain-relieving drugs and many more
patients would suffer, especially at the end of life.
Pain relief therapy should be managed by healthcare
professionals--physicians, nurses, and pharmacists--not by federal
law enforcement officers. The Pain Relief Promotion Act and the
Hatch Substitute explicitly put the DEA in the middle of critical
medical decision-making. They do so by flagging any deaths that
follow the prescription of controlled substances. In those cases,
the agency may then review the use of pain medications and decide
whether a physician's intentions were to manage pain or hasten
death. The very threat of regulatory intervention and oversight--
and the fear of having their intentions misconstrued--could
dissuade physicians from using aggressive efforts that are often
needed to relieve pain effectively.
The Pain Relief Promotion Act and its enforcers will not be
able to clearly distinguish between legitimate medical use of
controlled substances and intentionally causing death. Drawing the
line is not easy for healthcare professionals with years of
experience. It certainly will not be easy for law enforcement
officers with no medical training. Many patients can tolerate and
indeed required extremely high doses of controlled substances to
relieve their pain and other symptoms, while the same dose in
another patient could be lethal. The line between increasing the
risk of death while treating pain (an allowable medical practice)
and intentionally causing death (a crime with severe penalties) is
a very fine one. Many physicians say they do not trust the DEA to
make this distinction and do not feel secure that the DEA will
protect them if they aggressively manage pain with opiods.
The ``double effect'' is already protected. Since at least
1990, the DEA has accepted the ``double effect'' aspect of pain
care--the recognition that aggressive pain relief may have the
secondary effect of hastening a patient's death--although many in
the medical community do not realize they are already protected at
the federal level. It is not necessary to formalize this policy in
statute, and doing so is certainly not worth the price of expanding
the DEA's role into medical oversight and investigation of
physicians' intent. What is needed is not a new law, but better
implementation by the DEA of existing policy on ``double effect''
and better education of physicians and other providers in the use
of opiods.
By adding even more changes to the Controlled Substances Act
than the original bill, the Hatch Substitute may create additional
ambiguity. Rising the burden of proof on the DEA to ``clear and
convincing evidence'' as provided in the Hatch Substitute is an
attempt to reassure practitioners, but making a physician's
internal mental intent in prescribing medication subject to
external second-guessing by any standard of proof will cause
apprehension. Further, while the Hatch Substitute says the bill
should not be construed to alter the role of the federal and state
governments in regulating the practice of medicine, it is unclear
what those roles currently are so physicians are unlikely to feel
reassured. Another section limits certain federal actions but then
undoes the limit by adding ``except that the Attorney General may
take such other actions as may be necessary to enforce this Act.''
As more provisions are added to the Controlled Substances Act under
the substitute amendment there is more new language requiring
interpretation which means there is more potential ambiguity
affecting all parties involved.
The funding provision in the Hatch Amendment suggests a new
enforcement function for the DEA despite statements by the bill's
supporters that no new authority or medical oversight is intended
in the 49 states other than Oregon. The provision refers to a new
section (relating to a practitioner's ``intent'' and ``purpose,''
and Oregon-type laws) as being ``added by this Act'' and earmarks
funds for ``carrying out'' the section. This appears to indicate
that a new function or standard would be applied to DEA activities
under the Diversion Control Program--a function or standard needing
funding--and that certainly would have a chilling effect on pain
management. As with other provisions, it is unclear how the DEA in
the future may interpret and implement the proposed section.
The Controlled Substances Act is an inappropriate and
ineffective vehicle for addressing the issue of assisted suicide.
For one thing, prohibiting just healthcare providers registered
under the CSA but not others from assisting in suicide--and
prohibiting only those assisted suicides in which controlled
substances are used--is a very narrow and ineffective way to ban
the practice. This proposed law would not stop the Dr. Kevorkians
of the world because they are not registered and do not use
controlled substances. Moreover, by threatening good pain
management the new law could have the intended impact of driving
even more people to seek suicide, assisted or otherwise, because
they cannot get relief from their excruciating pain.
Separate Issues Calling for Separate Legislation
There are two big, highly complex issues involved in H.R. 2260: (1)
physician-assisted suicide, and (2) the need for better pain
management. Each issues raises important unanswered questions and
deserves full and poverty consideration in its own right. Assisted
suicide goes far beyond the use of controlled substances. And relieving
pain goes far beyond the DEA.
Assisted suicide should be dealt with in a separate law, not linked
to the medical practice of pain management. We urge that you address
each of these two issues separately--not linking them together--and
that you act on each issue on its own merits. Potentially serious and
far-reaching changes in the treatment of pain should not occur simply
as the by-product of a bill on assisted suicide.
We urge the Members of the Judiciary Committee not to risk causing
more pain for people who have already suffered enough by passing the
Pain Relief Promotion Act when there are better ways to ban assisted
suicide and better ways to promote pain relief. Don't turn patients
with pain into political pawns by wrapping their medical care into the
debate on physician-assisted suicide. Don't risk turning the ``War on
Drugs'' into a ``War on Patients.'' Don't pass the misnamed and
misguided Pain Relief Promotion Act.
__________
Prepared Statement of Joseph J. Fins, M.D., F.A.C.P.
Mr. Chairman, Senator Kennedy and distinguished members of the
Committee. Thank you for this invitation to testify regarding the Pain
Relief Promotion Act of 1999. I appreciate this opportunity to comment
on the important legislation and initiative to improve end-of-life care
and pain management.
By the way of background, I am a member of the faculty at Weill
Medical College of Cornell, Director of Medical Ethics at the Cornell
Campus of New York Presbyterian Hospital in New York City, Associate
for Medicine at the Hastings Center and a Project on Death in America
Faculty Scholar of the Open Society Institute.\1\ My academic, research
and clinical work is in medical ethics, the care of the dying, and
educational efforts to improve training in palliative care for medical
students and resident physicians.\2\ \3\ \4\ \5\ \6\ I was privileged
to serve on the New York State Attorney General's Commission on Quality
Care at the End-of-life convened by former Attorney General Dennis C.
Vacco after he represented New State before the Supreme Court in the
physician-assisted suicide case, Quill v. Vacco.\7\
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Footnotes at end.
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As a practicing internist who has cared for dying patients as well
as a medical ethicist who consults regularly on end of life care issues
in a major academic medical center, I am deeply concerned about the
quality of care that is provided to dying patients and their families.
I know first hand that care is often lacking because clinicians are
inadequately trained in pain and symptom management or because of an
often pervasive avoidance of issues surrounding death, dying and
mortality.\8\
For these reasons I am especially gratified that this bill is being
debated and these hearings have been convened. I believe that we as a
nation can and must do a better job of making life's final passage more
humane and compassionate.
Having said this, I am not convinced that Senate Bill 1272 will
have its desired effect of improving the care of dying patients and
easing the burden imposed by inadequate pain and symptom management. I
am deeply concerned that the proposed provision to ensure the
legitimate use of controlled substances by ``enforcement actions by law
enforcement personnel'' to ``accommodate such use'' will have a
chilling effect on pain management in the clinical setting. This
provision will complicate an already tenuous situation with respect to
pain management, which this legislation is trying to ameliorate.
As the Committee certainly appreciates, the academic literature in
medicine and medical ethics amply demonstrates that pain is under
recognized and under treated at the end of life.\9\ Upwards of 50% of
Americans die in moderate to severe pain.\10\ This is especially tragic
because the technology and pharmacology exists to ensure that dying
patients die comfortably.\11\ \12\
The reasons for the under-use of pain medications are multi-
factorial. They include scientifically unfounded concerns about
addiction, restrictive drug laws, cultural and attitudinal barriers and
regulatory impediments that impede access to controlled substances.\13\
\14\ \15\ These factors lead to a burden of treatable distress for
patients that are ethically unacceptable.
Furthermore, at the end of life, some clinicians are reluctant to
use sufficient dosages of opiods to relive pain because they fear that
this may hasten death and that the clinically appropriate use of pain
medications could be confused with physician-assisted suicide. Widely
endorsed ethical norms in medical practice from a range of clinical
societies and a recent decision of the U.S. Supreme Court unequivocally
affirm the physician's obligation to relieve pain even if doing so may
hasten an inevitable death.\16\ Ethicists often invoke the doctrine of
double effect to distinguish interventions to relieve suffering that
may hasten death from physician-assisted suicide or euthanasia when
death is intended.\17\
Organized medicine, especially the American Board of Internal
Medicine and the American Medical Association has made great progress
in getting the message out that the use of opiods in pursuit of pain--
even if their use hastens an expected death--does not constitute
physician-assisted suicide.\18\ \19\
In this evolving environment, the enforcement provision could erode
this progress. Because the ethical doctrine of double effect hinges on
the sometimes ambiguous question of the intent of the physician when
prescribing the medication, many physicians will opt to avoid this gray
zone and not prescribe needed medication to dying patients.
One could well envision a physician's concern when prescribing
opioids for a dying patient with cancer who had been treated with pain
medications for months before death. Given the pharmacology of opioids
and the development of tolerance the patient requires higher dosages of
medication over time for an adequate analgesic effect. When the patient
dies she will be on a large but clinically appropriate dose of
medication. Will physicians be comfortable escalating does of opioids
to adequately treat their patients when they also are worrying about
whether a law enforcement agent will appreciate that such drug
escalation in a function of pharmacology and disease progression? Who
will assure the concerned practitioner that an over zealous prosecutor
will not mistake appropriate clinical conduct as physician-assisted
suicide? Such investigations have already occurred to the detriment of
appropriate end of life care and pain management.\20\ \21\ \22\
Given these concerns, the enforcement provision could have the
unintended effect of leading physicians to be even more hesitant to
prescribe opioids out of fear that their use will trigger an
investigation. Although the intention of the bill is otherwise, this
provision would have the dire de facto effect of criminalizing the use
of opiods at the end of life. This would be a tragedy for dying
patients and their families who would have to watch them suffer.
As a physician, it seems inappropriate to me that medical practice
should be dictated by the fear of a regulatory agency and not by
professional and scientific norms. The enforcement provision seems
intrusive and a breach of the therapeutic relationship that must exist
between patient and physician. In an era when legislators from both
parties bemoan the intrusion of managed care bureaucrats in the doctor-
patient relationship,\23\ the insertion of drug enforcement personnel
at the bedside of dying patients seems especially egregious.
From a policy standpoint, these developments would be an
unfortunate reversal of progress that has been made in medical
education altering physician perceptions about the use of opioids. It
will reverse the progress that has been made over the past ten years to
educate physicians about the proper use of these medications. This
legislation could further exacerbate the under-use of opioids and
dramatically undermine the care of the dying.
As I understand this legislation, one of its intended goals is to
promote pain management and palliative care without sanctioning or
permitting physician-assisted suicide or euthanasia. I have written
about the ethics of physician-assisted suicide.\24\ \25\ \26\ Beyond
this theoretical examination of this issue, I have expressed my belief
that the legalization of physician-assisted suicide would be bad public
policy and not meet the needs of dying patients and their families. I
have advanced this argument during the judicial proceedings leading up
to the Supreme Court's decision as well as in the context of the debate
surrounding Oregon's Proposition 16 which ultimately legalized
physician-assisted suicide in the state. \27\ \28\
It is important to appreciate that I am against the enforcement
provision and remain opposed to physician-assisted suicide. I do not
oppose this legislation because I am in favor of physician-assisted
suicide. Although I respect the democratic process that lead to the
passage of their law, I oppose the developments in Oregon. My
opposition to this Act stems from my belief that its passage would
undermine end of life care and leave a terrible legacy of pain and
distress in its wake.
Finally, it is ironic that the enforcement provision would be
advanced in light of the work of the 1997 report of the Institute of
Medicine examining the care of the dying. This distinguished panel made
wide ranging recommendations for improvement of the status quo by
addressing professional competence, pain and symptom management, health
care financing of palliative care, reform of restrictive drug
prescription laws, medical education, research in end-of-life care and
encouraging a public dialogue about our societal obligations to the
dying and their families.\29\ It is important to note that among their
recommendations was the easing of restrictive prescription laws, not
increased regulatory review as would follow from the passage of the
Pain Relief Promotion Act of 1999.
For these reasons, I think the better course of action would be to
adopt the provisions advanced by Senator Wyden in Senate Bill 941. This
legislation is consistent with the scholarly and thoughtful
recommendations of the Institute of Medicine Report and leaves the care
of dying patients to their doctors, not law enforcement agents. That is
how each of you will want it if you or a loved one was dying and in
pain.
Mr. Chairman, thank you for this opportunity to testify before your
Committee and to comment on this important issue.
footnotes
\1\ The views and opinions expressed in this testimony are my own
and not necessarily those of any of the organizations with which I am
affiliated.
\2\ Miller FG and Fins JJ. A Proposal to Restructure Hospital Care
for Dying Patients. New England Journal of Medicine 1996;334:1740-1742.
\3\ Fins JJ, Miller FG, Acres CA, Bacchetta MD, Huzzard LL, and
Rapkin BD. End-of-Life Decision-Making in the Hospital: Current
Practices and Future Prospects Journal of Pain and Symptom Management
1999;17(1):6-15.
\4\ Fins JJ. Case Study Commentary: Resuscitation in Hospice. The
Hastings Center Report 1998;28(6):21-22.
\5\ Fins JJ, Professionalism and Pain Management. Journal of Pain
and Symptom Management. In Press.
\6\ Fins JJ. Acts of Omission and Commission in Pain Management:
The Ethics of Naloxone Use. Journal of Pain and Symptom Management
1999;17(2):120-124.
\7\ Attorney General Dennis C. Vacco's Commission on Quality Care
at the End of Life. Final Report. New York. July 1998.
\8\ Fins JJ Death and Dying in the 1990's: Intimations of Reality
and Immortality. Generations: Journal of the American Society on Aging
1999;23(1):81-86.
\9\ Cleeland CS, Gonin R, Hatfield AK, et al: Pain and its
Treatment in Outpatients with Metastatic Cancer. N Engl J Med
1994;330:592-596.
\10\ SUPPORT Principal Investigators. A controlled trial to improve
care for seriously ill hospitalized patients: The Study to Understand
Prognoses and Preferences for Outcomes and Risks and Treatments
(SUPPORT). JAMA 1995;274:1591-1598.
\11\ World Health Organization. Cancer Pain Relief and Palliative
Care. Geneva: WHO, 1996.
\12\ Hanks G and Cherny N. Opioid analgesic therapy. In, Oxford
Textbook of Palliative Medicine, 2nd Edition. Doyle D, Hanks GWC, and
MacDonald N, editors. New York: Oxford University Press, 1998 pp. 331-
355.
\13\ Hill CS Jr. The Barriers to Adequate Pain Management with
Opioid Analgesics Semin Oncol 1993; 20(suppl 1): 1-5.
\14\ Reidenberg MM. Barriers to Controlling Pain in Patients with
Cancer Lancet 1996;347(9011):1278.
\15\ Fins JJ. Public Attitudes about Pain and Analgesics: Clinical
Implications Journal of Pain and Symptom Management 1997;13(3):169-171.
\16\ Burt RA. The Supreme Court Speaks--Not Assisted Suicide but a
Constitutional Right to Palliative Care N Engl J Med 1997;337:1234-6.
\17\ Beauchamp TL, Childress, JF. Principles of Biomedical Ethics,
4th ed. New York: Oxford University Press, 1994. pp. 206-211.
\18\ American Board of Internal Medicine. Caring for the Dying:
Identification and Promotion of Physician Competency. Philadelphia.
ABIM. 1996.
\19\ American Medical Association. EPEC Project-Education for
Physicians on End-of-Life Care. Chicago. American Medical Association.
1998
\20\ Stern Hyman C. State Medical Boards and Pain Management
Journal of Pain and Symptom Management 1998;15:379-81.
\21\ Virginia Board of Medicine against William E. Hurwitz.
\22\ Hoover v. Agency for Health CAre Administration. 676 So. 2d
1380 (Fla. Dist. Ct. App. 1996).
\23\ Fins JJ. Challenges to the Doctor-Patient Relationship in
Managed Care: A Tale of Two Prescriptions. Seminars in Medical Practice
1998;1(1):22-26.
\24\ Fins JJ and Bacchetta MD. Physician Assisted Suicide and
Euthanasia Debate: An Annotated Bibliography of Representative
Articles. The Journal of Clinical Ethics 1994;5(4):329-340.
\25\ Fins JJ and Bacchetta MD. Framing the Physician-Assisted
Suicide and Voluntary Active Euthanasia Debate: The Role of Deontology,
Consequentialism, and Clinical Pragmatism Journal of the American
Geriatrics Society 1995;43(5):563-568.
\26\ Fins JJ and Viederman M. Case Study Commentary: But is it
Assisted Suicide? The Hastings Center Report 1995;25(3):272-25.
\27\ Fins JJ. Physician Assisted Suicide and the Right to Care.
Cancer Control: Journal of the Moffitt Cancer Center 1996;3(3):272-278
\28\ Fins JJ. What Medicine and the Law should do for the
Physician-Assisted Suicide Debate. CCAR Journal Spring 1997;46-53.
\29\ Committee on Care at the End of Life, Field MJ and Cassel CK,
editors Approaching Death: Improving Care at the End of Life.
Washington, D.C. Institute of Medicine-National Academy Press. 1997.
__________
Prepared Statement of Scott M. Fishman, M.D.
My name is Scott Fishman and I am Chief of the Division of Pain
Medicine and Associate Professor of Anesthesiology at The University of
California, Davis School of Medicine. I specialize in Pain Medicine,
have board certification in Pain Medicine, Internal Medicine, and
Psychiatry, and my life work has been the treatment of suffering and
improvement of quality of life. I oversee a large office and hospital-
based program for pain management in adults and children with acute or
chronic pain or pain related to terminal illness. I have recently
authored a book title The War on Pain for the general consumer audience
and I have published professional works in the medical literature on
topics related to pain management.
I have reviewed the ``Hatch substitute'' to H.R. 2260 and am
opposed to it. But I am also firmly opposed to physician-assisted
suicide. Advancements in Pain Medicine have made the notion of
hasteining death for patients who are in too much pain unnecessary.
It is because aggressive pain management can be so effective for
patients in serious pain, especially near the end of life, that I
oppose the current ``Hatch substitute'' bill as well as the earlier
version of the Pain Relief Promotion Act. Either version of the bill
will limit our ability as physicians to effectively treat pain.
progressing in treating pain and suffering has come, in large part,
through decreasing the barriers for appropriate use of our strongest
pain relievers, the opioid narcotics. The threat of potential
punishment for aggressive pain management misconstrued as physician-
assisted suicide will increase a prominent barrier to pain relief. The
``Hatch substitute'' will send a chilling message to those who use
narcotic medications in the treatment of pain. The possibility of
having one's actions misinterpreted with extremely harsh consequences
will almost certainly make most physicians think twice before ordering
a strong narcotic pain reliever, and many will unfortunately opt to
ignore the patients' pain. While this may seem like a rash conclusion,
it is what we have seen throughout our own medical history as well as
in our present state of healthcare. At present, although pain is
treatable in the vast majority of cases, it is treated effectively in
only the minority of cases. Even children with terminal illnesses are
still under-treated for their suffering. Subtle barriers to prescribing
narcotics still impede good pain management and the subtle, yet clear
message of greater scrutiny over narcotic prescribing will only further
increase reluctance to treat pain.
No matter how many strong appeals are made for good pain
management, how many resources are offered to advance knowledge, or how
high the bar is set on proving intent in physician-assisted suicide,
physicians are human, and I believe that human nature will respond to
the looming threat of serious punishment. In my opinion, those few,
well intentioned but ill-advised physicians who see physician-assisted
suicide as a viable option will not be readily identified while the
rest of us, who are able to make physician-assisted suicide unnecessary
with good pain medicine, will be undermined. It is ironic that the
``Hatch substitute'', which seeks to prevent physician-assisted
suicide, will ultimately impair one of the truly effective counters to
physician-assisted suicide, which is swift and effective pain medicine.
Thus, the ``Hatch substitute'' will neither bring about what it seeks
to accomplish, nor prevent what it seeks to block.
________
Prepared Statement of David E. Joranson
My name is David E. Joranson. I am a Senior Scientist and Director
of the Pain & Policy Studies Group, University of Wisconsin
Comprehensive Cancer Center, Madison. I thank the Committee on Health,
Education, Labor and Pensions for the opportunity to address the
Committee.
I applaud the Committee for taking an interest in what you can do
to improve pain management and end of life care in the United States;
this is of course the ultimate matter of quality of life for us all. I
encourage the Committee to take time to develop a full perspective on
the human, medical, social and policy aspects, to become familiar with
the unique barriers, assess what is already being done, and then
consider the options. I can contribute to one part of your picture; my
area of knowledge is controlled substances policy and the regulation of
medical practice in relation to pain management.\1\
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\1\ My knowledge and experience with controlled substances law goes
back about thirty years, to the vigorous debate and final adoption in
1970 of the CSA. In addition I have had the following relevant
experiences: administrative officer for the State of Wisconsin's
Controlled Substances Board; worked with Congressional subcommittees to
successfully adopt amendments to the CSA in 1984 to strengthen DEA's
program against diversion of controlled substances; co-founded the
National Association of State Controlled Substances Authorities and the
first State Cancer Pain Initiative, which became a World Health
Organization Demonstration Project; conducted research on Federal and
state controlled substances laws and state professional practice laws
and regulations; served for several years on the drafting committee of
the National Conference of Commissioners on Uniform State Laws to
revise the Uniform Controlled Substances Act for the States; assisted
in the development of state medical board guidelines for the use of
controlled substances in the treatment of pain; worked with the
National Conference of State Legislatures to develop informational
materials for state legislatures.
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The Committee has before it two pieces of legislation to improve
pain management: One is S. 941, to amend the Public Health Service Act,
the other is S. 1272, to amend the Controlled Substances Act (CSA). My
comments will focus on the risks that should be considered before
amending the CSA as has been proposed.
It is important to realize that the CSA has a dual purpose relating
to both drug abuse prevention and also to recognizing and preserving
the important medical uses of many controlled substances. Indeed,
achieving a `balanced' drug control policy is an obligation of
governments which is established by the United Nations Single
Convention on Narcotic Drugs, 1961, i.e., to prevent the misuse of
drugs without interfering with their medical use, in particular for the
relief of pain and suffering. The CSA was structured by the Congress to
achieve a balance between these two purposes. When controlled
substances policy loses its balance the chances increase for there to
be conflict between law enforcement and medicine, with resulting harm
to pain management and patient care.
The CSA is a law enforcement statute aimed at preventing abuse of
controlled substances, and for these purposes it is administered by the
Attorney General (AG). The CSA also recognizes that many controlled
substances (such as opioid analgesics) are necessary to maintain public
health, and that they must be available to meet legitimate medical and
scientific needs.
In order to achieve this balance, the Congress spelled out several
fundamental principles which recognize that certain functions are to be
carried out under jurisdictions other than federal drug law enforcement
in the Department of Justice. These three areas are: (1) the medical
and scientific decisions necessary to administer the CSA, (2) the
recognition of the medical uses of drugs, and (3) the recognition of
the role of State laws, especially those regulating medical practice.
(1) Medical and scientific decisions. The Congress decided in 1970
that medical and scientific decisions, such as the evaluation of the
potential for abuse of drugs being placed in the five schedules of the
CSA, are the responsibility of the Secretary of the Department of
Health and Human Services (DHHS), not the AG (See Section 811.(b) of
the CSA). The principle of ``balance,'' was established in the course
of vigorous and extended debate over a Department of Justice bill that,
as proposed, would have given the AG exclusive power to make decisions
of a medical and scientific nature.\2\ Congress appropriately rejected
this approach and assigned this authority to the DHHS. Medical and
scientific organizations were actively involved to ensure that the CSA
was balanced in this respect, and this policy has endured to this day,
including amendments to the CSA which were adopted in 1984 to increase
DEA's capability to revoke practitioner registrations in the public
interest.
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\2\ ``Controlled Dangerous Substances, Narcotic and Drug Control
Laws'' Hearings before the U.S. House of Representatives Committee on
Ways and Means. Washington, DC: U.S. Government Printing Office, 1970.
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(2) Relation of the CSA to the Federal Food, Drug and Cosmetic Act.
The Congress determined a second fundamental principle, that the CSA is
not to ``be construed as in any way affecting . . . the provisions of
the Federal Food, Drug and Cosmetic Act'' (see Section 902). It is
extremely important to recognize that it is under authority of the
FFDCA, not the CSA, that drugs are approved as safe and effective for
medical use, so that they can be marketed lawfully in interstate
commerce. In addition, federal administrative law and court decisions
have made it clear that although the Food and Drug Administration (FDA)
approves drugs for marketing, it does not regulate medical practice,
which is left to the States. Many opioid analgesics have been approved
for treatment of pain, and also for diarrhea, and cough. The fact that
opioids (and many other drugs approved for human use under the FFDCA)
are also controlled substances under the CSA is not intended to affect
their status as drugs which are safe and effective and may be
prescribed by physicians. Indeed, the difference between legal and
illegal drugs in the schedules of the CSA is defined by whether a drug
is approved under the FFDCA as having an accepted medical use.
(3) Relation of the CSA to State laws. The third principle reflects
the fundamental relation between the federal government and the States.
The CSA is not intended to occupy areas of State laws which are within
the authority of the States:
No provision of this subchapter shall be construed as
indicating an intent on the part of the Congress to occupy the
field in which that provision operates, including criminal
penalties, to the exclusion of any State law on the same
subject matter which would otherwise be within the authority of
the State, unless there is a positive conflict between that
provision of this subchapter and that State law so that the two
cannot consistently stand together. (CSA, Section 903)
It would be extraordinary to invoke the federal CSA to contravene
the policy of a single state, or to use the CSA to establish medical
and scientific policy with respect to drugs.
Mr. Chairman, against the context of the foregoing fundamental
principles which limit the scope of the CSA, I offer a few concluding
observations:
(1) Opioid analgesics are already legal. This is determined under
the FFDCA. To define or comment on the medical uses in a federal drug
law enforcement statute ignores one of the fundamental principles of
balance.
(2) The DEA has already said that they understand that opioid
analgesics are needed for chronic pain. A 1974 DEA regulation made it
perfectly clear that nothing in the CSA precludes practitioners from
providing opioids for intractable pain.\3\ DEA reemphasized this point
again in its 1990 Physicians Manual, encouraging physicians to
prescribe opioids when they are needed: \4\
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\3\ Code of Federal Regulations Part 21, Section 1306.07(c)
\4\ Drug Enforcement Administration. Physician's Manual: An
Informational Outline of the Controlled Substances Act of 1970. U.S.
Department of Justice: DEA; March, 1990.
Controlled substances and, in particular, narcotic analgesics,
may be used in the treatment of pain experienced by a patient
with a terminal illness or chronic disorder. These drugs have a
legitimate clinical use and the physician should not hesitate
to prescribe, dispense or administer them when they are
indicated for a legitimate medical purpose. It is the position
of the Drug Enforcement Administration that these controlled
substances should be prescribed, dispensed or administered when
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there is a legitimate medical need. (DEA, 1990, p. 21).
Indeed, DEA representatives are to be commended for their
willingness to clarify federal policy in relation to medical practice;
they have spoken at numerous pain conferences around the U.S. The DEA,
and major medical organizations, have endorsed a new Model Guideline
\5\ on the use of controlled substances for pain.
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\5\ Federation of State Medical Boards of the United States, Inc.
Model Guidelines for the Use of Controlled Substances for the Treatment
of Pain. Euless, TX; May 1998.
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(3) New DEA regulations? S. 1272 contemplates that the AG/DEA may
promulgate ``regulations to implement this Act.'' Is it appropriate to
give DEA rule-making authority in this sensitive area? How will the
agency distinguish between pain management and assisted suicide? Apart
from the inherent difficulty in determining a physician's intention, a
recent review supported the notion that opioids hasten death is more
myth than fact.\6\ Given that H.R. 2260 allows for DEA regulations in
connection with new language about pain, hastening death and assisted
suicide, it seems likely that the Attorney General and the DEA would be
faced with decisions which involve medicine and science, conflicting
with the first fundamental principle.
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\6\ Fohr SA. The double effect of pain medication: Separating myth
from reality. Journal of Palliative Medicine. 1998; 1(4):315-328.
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(4) The potential for a chilling effect. I will close with the
following point. I assume that this Committee fully accepts that pain
is not adequately managed in this country, and that this is due, in
part, to the under-use of opioid analgesics, especially, but not only,
for people at the end of life. One of the reasons is that while many
physicians still do not have sufficient knowledge about pain
management, they also fear being investigated if they prescribe `too
much.' the origin of these fears goes back many years, and are in part
an unintended effect of the war on drugs. The solution to this problem
requires that we give greater attention to achieving a balanced
controlled substances policy which clearly recognizes that controlled
substances have important medical uses, and that we communicate it so
that it is understood by regulators and practitioners. The amendments
to the CSA which have been proposed threaten to upset the balance that
the Congress has established, and which many of us have been working to
achieve.
__________
Prepared Statement of National Association of Pro-Life Nurses
The National Association of Pro-life Nurses strongly supports the
Pain Relief Promotion Act (HR 2260) and we urge you to vote for its
passage to help insure adequate pain relief for our patients.
The National Association of Pro-life Nurses is a non-profit
organization with several hundred members engaged in our profession.
Our members live and work in some 46 states of the United States of
America. We are united by a shared dedication to the ideals of our
caring and ministering profession; the promotion of health, the
alleviation of suffering, and the respect for and preservation of human
life.
Double Effect
This bill provides an important tool to be used in administering
adequate pain relief while it prohibits the use of controlled
substances for the purpose of causing death. With HR 2260, a doctor
cannot be held responsible for the death of a patient receiving large
doses of these potentially lethal substances if the intention is to
relieve the pain of the suffering patient, not to end his or her life.
Our members have no problem with administering dosages of medication
for pain relief beyond what would normally be considered ``safe'' doses
when the patient is suffering excruciating pain. But we do object to
the use of any substance which may have this double effect when the
intent is to cause the death of the patient. We are morally opposed to
any measures taken to hasten or cause the death of any person and what
this practice to remain outside the acceptable practice of medicine.
Promotion of Better Pain Relief
This bill removes a barrier that has impeded good pain control in
the past, namely the fear of doctors that they will be accused of
euthanasia for aggressively treating the excessive pain experienced by
some patients. We are assured that they will be able to administer
whatever dosage it takes to achieve adequate pain relief. We note the
absence of empowerment to seek out physicians who use more than average
doses of medication than their fellow practitioners, and the
prohibition of non-medical persons from being the arbitors in what
constitutes good pain management. This is especially reassuring to
those in fields such a oncology where patients often need much larger
doses of medication for satisfactory pain control. We are pleased to
find that the concerns of many medical groups, initially hesitant to
support the bill, have had these concerns satisfactorily addressed, and
most are now in support of the bill.
Research/Education
The provisions in the bill for more research in palliative care and
better education of health care professionals in pain relief is, from
our nursing perspective, most welcome and something long overdue.
Treatment of pain comprises a good portion of what many of us in the
medical profession are called to do, yet the time spent in training in
this area does not reflect the time consumed in the actual practice of
medicine. Research in this area has never been as extensive as that of
seeking other medical advances, even though many of the new
technologies developed are an even greater source of pain and
discomfort. This provision is warmly welcomed by our members.
Many of us in the nursing profession can cite examples of patients
in extreme and seemingly intractable pain for whom greatly increased
doses of medication are ordered. These doses are often determined to be
lethal for a non-suffering person, yet the suffering patient
experiences little suppression of his or her vital signs as a result.
It requires a person trained and skilled in the detection and treatment
of such pain to be effective in relieving it.
``Chilling Effect''
Returning to the promotion of better pain relief in this bill, I
would refer you to the studies to which you have access in great detail
in other testimony. They are studies done in several states in which
assisted suicide is banned by law. The studies indicate a far greater
use of the classic pain control drug, morphine sulfate, which is a
Class A controlled narcotic, in those states after this law has been
passed. When assisted suicide is prohibited by law, greater steps are
taken to relieve the pain of suffering patients so that they are not
driven to request such a drastic measure as taking their life. And
certainly any remaining fear of the ``chilling effect'', as claimed by
some of the opponents of the bill, would be further removed by the
research and education provisions.
Patient Advocates
Although the provisions of this bill are directed at the physician
as the prescriber of the medication, our contact with the patient is
often closer and more personal than that of the physician. Therefore,
the concerns of this bill have perhaps a greater impact on our day to
day experiences than that of the physician. We are the ones caring for
the patient after the physician departs, left to deal with the torment
of excruciating pain suffered by one in our charge. Knowing that the
physician cannot be held responsible for the death of the patient gives
us more incentive to help the physician to be more aggressive in the
treatment of pain.
Conscientious Objection
The last consideration is for us as nurses. We are charged with
carrying out the orders of the physician who has the ultimate care of
the patient. Our existence as an organization is based on a need to
affirm to nurses that they have rights, too, and one of those rights is
the right to refuse to participate in practices which offend our
conscience. All of our members are committed to respect for life from
conception to natural death. That does not include death by medication.
This is not only a problem for us as individuals who are charged with
the execution of the doctors orders, but for the medical profession
which must then deal with how to address this concern when those
charged with carrying out the orders are unable to comply. As more and
more situations arise where we are being asked to compromise our moral
beliefs, it becomes very difficult for nurses to perform their duties.
Consequently, it is difficult for administration to deal with this
problem. Nursing has always been and, because of its service nature,
will always be, comprised primarily of individuals of altruistic
motivation who will rise to the defense of the vulnerable and
defenseless. Not asking us to perform these tasks in the first place,
as this bill would do, goes a long way toward keeping some of the most
compassionate and caring members of the nursing profession at the
bedside of the suffering.
--Respectfully submitted by Marianne Linane, Executive Director,
National Association of Pro-life Nurses.
__________
Prepared Statement of the National Conference of Catholic Bishops
The Catholic bishops of the United States strongly support the Pain
Relief Promotion Act of 1999 (H.R. 2260), as well as the substitute
bill proposed by chairman Orrin Hatch which incorporates revisions
requested by medical organization (henceforth ``Chairman's
Substitute''). We believe that swift enactment of this legislation is
needed for two purposes: (1) to correct a seriously flawed 1998 ruling
by U.S. Attorney General Janet Reno, which authorizes the use of
federally regulated drugs to assist vulnerable patients' suicides
wherever the practice is permitted by state law; and (2) to promote the
legitimate use of these drugs to relieve pain and other distressing
symptoms, especially for patients who are terminally ill.
In our view, these two goals are both important, and are closely
related. Terminally ill patients deserve better pain control precisely
because they have the same innate worth and dignity as all other human
beings and are in special need of our love and support. When a society
singles out these patients as candidates for physician-assisted
suicide, it denies the value of their very lives, and thereby
undermines respect for their dignity and their legitimate needs--
including their need for the best possible palliative care.
When we accept assisted suicide as a ``good enough'' solution for
these patients, we preach a counsel of despair to all terminally ill
patients. We tell them that we find it easier to kill them than to find
ways to kill their pain. By rejecting the ``quick fix'' of assisted
suicide, however, we reaffirm to ourselves and to the medical
profession that these patients have lives worth living, and that they
deserve real solutions for the pain, depression and isolation that they
may experience.
In our view, then, the two titles of this bill--one providing
federal support for training in palliative care, the other clarifying
federal law on the use of controlled substances--serve the same goal of
promoting genuine supportive care for some of our most vulnerable
citizens. Because medical professionals can speak with greater
expertise on the palliative care provisions in Title I of the
Chairman's Substitute, we would like to focus on the urgent need to
enact Title II, clarifying the Controlled Substances Act.
The Need to clarify the Controlled Substances Act
On June 5, 1998, contradicting an earlier determination by her own
Drug Enforcement Administration, U.S. Attorney General Janet Reno ruled
that the State of Oregon, by rescinding its own penalties for assisting
the suicides of certain patients, had effectively succeed in
unilaterally amending federal drug laws as well. According to the
Attorney General, Oregon's law had established assisted suicide as a
``legitimate medical practice'' within Oregon's borders--and the
federal government lacked any basis for disagreeing with this judgment.
Under this ruling, however, federal intervention by the Drug
Enforcement Administration (DEA) ``may well be warranted'' in other
states--and is warranted even in Oregon, when a physician ``fails to
comply with state procedures'' regarding how and when to assist
suicides. Federal law will protect the lives only of those still deemed
by the state to deserve suicide prevention, instead of suicide
assistance.
Thus Attorney General Reno's ruling requires the federal government
to ratify Oregon's assisted suicide policy--and to help implement it,
by licensing physicians to prescribe and distribute federally regulated
drugs for the required lethal overdoses. This is not only morally
wrong--it directly contradicts everything that Congress and federal
agencies have ever said about terminally ill patients and assisted
suicide:
--Current federal policy demands an increased penalty when the
victim of a federal crime is seriously ill or otherwise ``unusually
vulnerable.'')\1\ Yet in Oregon, it is now the U.S. Justice
Department's policy that the serious illness of the victim transforms a
crime into a ``legitimate'' medical procedure, so that it is no crime
or offense at all. Oregon's discriminatory policy, which stigmatizes an
entire class of patients and denies them the equal protection of the
law, has effectively been ratified by federal administrative fiat.\2\
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\1\ United States Sentencing Commission, Guidelines Manual, p. 227,
Sec. 3A1.1.
\2\ The Oregon law has been found to violate constitutional
guarantees of equal protection by the only federal court to review that
law on the merits. See Lee v. Oregon, 891 F. Supp. 1429 (D. Or. 1995),
vacated on other grounds, 107 F.3d 1382 (9th Cir. 1997), cert. denied,
522 U.S. 927 (1997). In its 1997 rulings on assisted suicide, the U.S.
Supreme Court noted that it has yet to review the validity of this
argument: ``Lee, of course, is not before us . . . and we offer no
opinion as to the validity of the Lee courts' reasoning. In Vacco v.
Quill . . ., however, decided today, we hold that New York's assisted
suicide ban does not violate the Equal Protection Clause.'' Washington
v. Glucksberg, 521 U.S. 702, 709 n. 7 (1997) (emphasis added). To this
day no appellate court has ruled on the constitutionality of law like
Oregon's.
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--As the U.S. Supreme Court noted in its 1997 rulings on assisted
suicide, it is a longstanding policy under the federal drug laws ``to
protect the terminally ill, no less than other patients,'' from
potentially lethal drugs.\3\ Yet in Oregon this policy is now turned on
its head, so that federal prescribing licenses are used precisely for
the purpose of facilitating lethal overdoes for the terminally ill.
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\3\ Washington v. Glucksberg, 521 U.S. 702, 729 (1997), quoting
United States v. Rutherford, 442 U.S. 544, 558 (1979).
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--In 1997, Congress almost unanimously approved the Assisted
Suicide Funding Restriction Act (42 U.S.C. Sec. 14401 et seq.) to
ensure that federal funds, health facilities and health programs are
not used for assisted suicide or euthanasia. The Senate approved this
legislation 99-to-0. Signing it into law, President Clinton said it
``will allow the Federal Government to speak with a clear voice in
opposing these practices''; and he warned that ``to endorse assisted
suicide would set us on a disturbing and perhaps dangerous path.'' Yet
an important federal statutory scheme, designed to ensure that
potentially dangerous drugs are used only to promote patients' health,
is now being used to condone and facilitate assisted suicide.
The Attorney General's ruling is especially indefensible as an
interpretation of the Controlled Substances Act (CSA). Nothing in that
Act indicates that an individual state, by dropping its own state
penalities for a form of manslaughter, can convert such killing into a
``legitimate medical purpose'' for the use of federally controlled
drugs within the meaning of the federal Act. Indeed, any ``states'
rights'' argument on this issue is contradicted by the plain language
and intent of the CSA. Provisions to ensure that narcotics and other
dangerous drugs are used solely for a ``legitimate medical purpose''
(21 C.F.R. Sec. 1306.04), and are never used to endanger ``public
health and safety'' (21 U.S.C. Sec. 823(b)(5)), have been included in
this Act and its implementing regulation precisely to establish a
uniform federal standard that would not rely on the vagaries of
individual state laws.\4\
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\4\ In particular, 1984 amendments to the CSA were designed ``to
make it easier for the [DEA] to suspend or revoke the authority of
physicians . . . who write or dispense prescriptions in a way that is
threatening to the public health or safety,'' even in cases where they
may not have been charged or convicted under state criminal statutes.
Remarks of Rep. Gilman, 130 Cong. Rec. H9681 (daily ed. Sept. 18,
1984), quoted in Trawick V. Drug Enforcement Administration, 861 F.2d
72, 75 n. * (4th Cir. 1988).
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A clear and explicit purpose of such provisions was to prevent the
use of federally regulated drugs for lethal overdoses, not only their
use for addiction. Obviously, using drugs to cause people's deaths is
an even greater threat to health and safety than using them to feed an
addiction.
Current enforcement of the CSA reflects this understanding. In the
past, physicians have had their DEA registrations revoked for giving
dangerous drugs to patients who then used them to commit suicide (see,
e.g., the case of Dr. Hugh Schade, reported at 60 Fed. Reg. 56354 [Nov.
8, 1995]). Practitioners can lose their registrations in such cases
even for negligently giving these drugs to patients who they should
have known might use them for suicide.\5\
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\5\ Thus H.R. 2260's affirmation that the relevant section of the
CSA does not authorize intentionally prescribing and dispensing
federally regulated drugs for the purpose of causing death is
restrained, and carefully focused on the legal anomaly created by the
Attorney General's ruling.
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Such enforcement has often relied on the separate federal policy of
protecting patients' health and safety, quite aside from whether a
practitioner has violated state criminal laws or even state medical
licensing standards. Especially since the CSA was clarified and
strengthened in 1984, ``state licensure is a necessary but not
sufficient condition for DEA registration'' (63 Fed. Reg. 8479 [Feb.
19, 1998]). By the same token, revoking a DEA registration does not
imply that a physician will lose his or her state medical license or
has violated state law.\6\ The Chairman's Substitute for H.R. 2260
makes explicit the States' sole authority to govern state medical
licensing and state prescribing privileges.
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\6\ ``Registration of a physician under the Controlled Substances
Act is a matter entirely separate from a physician's State license to
practice medicine. Therefore, revocation of registration only precludes
a physician from dispensing substances controlled under the Controlled
Substances Act and does not preclude his dispensing other prescription
drugs or his continued practice of medicine.'' S. Rep. No. 225, 98th
Congress, 2d Sess., reprinted in 1984 U.S. Code Cong. & Admin. News
3182, 3449 n. 40.
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To reaffirm this longstanding and consistent federal policy that
all citizens, including the terminally ill, deserve protection from the
lethal misuse of potentially dangerous drugs, new legislation is needed
and long overdue.
Choosing the Means: New Features of H.R. 2260
In 1998 legislation was introduced to correct the Attorney
General's legal error. The Lethal Drug Abuse Prevention Act (H.R. 4006,
S. 2151) was approved by House and Senate Judiciary Committees, but was
opposed by many medical groups who claimed it would have an adverse
effect on physicians' ability or willingness to prescribe controlled
substances for pain relief. This year's Pain Relief Promotion Act
addresses these concerns in the following ways:
1. In order to correct the anomaly the Attorney General has created
in the way federal law is enforced in Oregon, last year's legislation
established a new substantive policy against the use of controlled
substances for assisted suicide throughout the 50 states. Critics
feared that this explicit new authority might be taken as giving the
DEA a new mandate to question and scrutinize physicians' medical
decisions in order to detect assisted suicides.\7\ H.R. 2260 is based
on a recognition that no new authority of this kind is needed. The
Attorney General herself has acknowledged that the DEA already has
authority to prevent the misuse of controlled substances for assisted
suicide in every state except Oregon (and even has that authority in
Oregon, when an assisted suicide does not comply with all the state's
guidelines). The only new explicit statement on this issue in H.R. 2260
is that a state, by enacting a law permitting assisted suicide, does
not succeed in changing the separate federal standard that already
applies to all other states--in other words, a law like Oregon's has no
``force and effect'' in determining whether a practitioner has violated
separate federal standards for protecting patients' health and safety.
This simply reaffirms what is already true under the federal Supremacy
Clause: Where state and federal law conflict, federal law governs. The
Chairman's Substitute also adds explicit statements that this bill
cannot be construed to alter the respective roles of state and federal
governments in regulating medical practice or to authorize new national
standards for clinical practice regarding pain management.
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\7\ Indeed, the bill's creation of a new medical advisory board to
review particular cases was taken by critics as evidence that massive
new enforcement actions were contemplated--though sponsors intended
this board as an independent panel of experts to be convened only at
the practitioner's request, to provide an additional shield against
medically uninformed enforcement actions.
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2. The 1998 bill gave priority to stating a new policy against
assisted suicide, then explained that this policy does not forbid the
legitimate use of controlled substances to control pain. In H.R. 2260
the emphasis is reversed: It contains a forthright and explicit
declaration on the legitimacy of using controlled substances to control
pain, then adds that this and other policy statements in the relevant
section of the CSA do not authorize the use of controlled substances
for assisted suicide. In several ways the Chairman's Substitute further
emphasizes the bill's strong commitment to promoting pain management
and palliative care: It adds a ``findings and purpose'' section on this
subject, reverses the order of the bill's titles to give greater
prominence to the palliative care provisions, and adds a provision
calling for a new decade of commitment to pain management.
3. H.R. 2260 contains a new mandate that the DEA's continuing
education programs for federal, state and local law enforcement
personnel include education in how their enforcement procedures can
better accommodate the legitimate medical use of controlled substances
for pain relief. Combined with the provisions supporting education and
training in palliative care for health professionals, this provision
underscores the federal policy that pain control is an important and
legitimate purpose for the use of federally regulated drugs--a policy
that has never before been so explicitly stated in federal statutes.
The Chairman's Substitute amends the provision on continuing education
for law enforcement personnel to make it unambiguously clear that these
personnel are to be trained in giving greater deference to physicians'
decisions in the field of pain medicine--not in making medical
determinations themselves.
The Pain Relief Promotion Act is carefully tailored to clarify
federal law on assisted suicide only to the minimum degree needed to
correct the Attorney General's ruling, so that the federal government
will no longer actively facilitate assisted suicide in any state that
has legalized the practice. It does not give new enforcement authority
to the DEA, and does not change the law at all in the vast majority of
states--except to give new emphasis to the legitimate use of federally
regulated drugs to control pain, and to provide a clearer ``safe
harbor'' from legal liability for health professionals committed to
such use.
Killing Pain vs. Killing Patients
Because the relationship between optimal pain management and
physician-assisted suicide is central to this legislative debate, the
difference--we would say, the contradiction--between the two practices
is worth further comment.
The medical profession has long recognized that efforts to control
pain using powerful drugs may sometimes have side-effects. Very rarely,
controlling pain in dying patients may require the use of such large
doses of drugs that the patient's breathing reflex may be suppressed
and the dying process hastened. The physician's intent in these cases,
however, is to use the minimum dosage needed to control the pain; any
risk of hastening death is not intended, but is foreseen as the
unavoidable side-effect of a legitimate medical action.\8\
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\8\ Such effects are far rarer than was once thought. ``No more
than 1 per cent of patients who receive narcotics for pain develop
serious respiratory depression.'' M. Angell, ``The Quality of Mercy,''
in 306 New England Journal of Medicine 99 (January 14, 1982). ``There
is close to universal ethical approval of the bold use of pain-control
measures even if their use risks decreasing the period of survival. Yet
palliative-care experience shows this situation to be extremely rare.
The drugs for pain relief are very safe. Palliative-medicine
specialists do not agree that good pain relief shortens life. Pain
relief without sedation is a central and achievable goal of palliative
care.'' J. Scott, ``Fear and False Promises: The Challenge of Pain in
the Terminally Ill,'' in I. Gentles (ed.), Euthanasia and Assisted
Suicide: The Current Debate (Stoddart: Toronto 1995) at 100.
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This principle of double effect is not especially obscure. The
difference between consequences which are intended, and those which are
only foreseen, is part of everyday life. As one federal appellate judge
has observed, when General Eisenhower gave the order for D-Day he knew
many American soldiers would die as a result--but that does not mean he
murdered them.\9\ Conversely, when King David ordered Uriah the Hittite
to the front line of battle, then called back his other men so Uriah
would be killed, he murdered him as surely as if he had wielded the
weapon himself (2 Sam 11:15-17).
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\9\ See Compassion in Dying v. Washington, 79 F.3d 790, 856 (9th
Cir. 1996)(Kleinfeld, J., dissenting), rev'd, 521 U.S. 702 (1997).
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The important factor here is the agent's intent--what am I trying
to achieve by this action? The goal of pain control is a patient who is
relieved of pain. The goal of assisted suicide is a world that is
relieved of one more patient. And this difference of purpose is
reflected in the different ways drugs are used in the two practices.
Pain control requires carefully titrating drugs to the point where pain
is relieved with a minimum of side-effects; assisted suicide generally
requires one sudden and massive dose of drugs, to make sure that the
patient does not have time to build up any resistance to the drugs'
lethal effects.
The euthanasia movement has tried to obscure this difference for
its own narrow purposes. Jack Kevorkian claimed in his assisted suicide
and murder trials that he was only trying to end ``suffering,'' though
the means he used had no analgesic properties. Assisted suicide
supporters filed many briefs with the U.S. Supreme Court two years ago,
claiming that pain control and assisted suicide were practically
indistinguishable. They lost this debate. As the Supreme Court has
said:
[A] physician who withdraws, or honors a patient's refusal to
begin, life-sustaining medical treatment purposefully intends,
or may so intend, only to respect his patient's wishes and ``to
cease doing useless and futile or degrading things to the
patient when [the patient] no longer stands to benefit from
them.'' Assisted Suicide in the United States, Hearing before
the Subcommittee on the Constitution of the House Committee on
the Judiciary, 104th Cong., 2d Sess., 368 (1996) (testimony of
Dr. Leon R. Kass). The same is true when a doctor provides
aggressive palliative care; in some cases, painkilling drugs
may hasten a patient's death, but the physician's purpose and
intent is, or may be, only to ease his patient's pain. A doctor
who assists a suicide, however, ``must, necessarily and
indubitably, intend primarily that the patient be made dead.''
Id., at 367. Similarly, a patient who commits suicide with a
doctor's aid necessarily has the specific intent to end his or
her own life, while a patient who refuses or discontinues
treatment might not . . . .
Logic and contemporary practice support New York's judgment that the
two acts are different, and New York may therefore, consistent with the
Constitution, treat them differently.\10\
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\10\ Vacco v. Quill, 521 U.S. 793, 801-02, 808 (1997).
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Since November 1994, when Oregon first approved its law allowing
physician-assisted suicide, all other states discussing the issue have
reaffirmed this distinction. No state has followed Oregon's lead;
several have passed new laws against assisted suicide, including
provisions to emphasize the distinction between assisted suicide and
pain control.\11\
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\11\ Since 1994 new statutes against assisted suicide have been
enacted in: Louisiana (1995); Rhode Island and Iowa (1996); Virginia,
Michigan and South Carolina (1998); and Maryland (1999). Between 1997
and 1998, three states (Kansas, Oklahoma and South Dakota) added to
their existing criminal prohibitions by providing civil penalties as
well. The Michigan law did not include an explicit disclaimer on the
legitimacy of pain control, but such legislation was later enacted
separately; Jack Kevorkian's flagrant but effective misuse of the
``principle of double effect'' in his trials made Michigan legislators
hesitant to include such language in their ban.
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What has happened to pain control in states enacting new bans, and
in states that have rejected proposals to legalize assisted suicide?
Time after time, actions to ban assisted suicide or to reaffirm
existing bans have been followed by advances and improvements in pain
control:
--When Rhode Island considered a new ban on assisted suicide in
1996, the state medical society objected that such a ban would have an
adverse effect on physicians' willingness to use drugs like morphine
for aggressive pain control.\12\ But in fact, the opposite happened. In
the year following enactment of the ban, according to official figures
from the DEA, Rhode Island more than doubled its per capita use of
morphine for pain control, rising from 46th among the states to 19th in
morphine use. To this day Rhode Island's use of morphine is twice what
it was before its ban was enacted. A similar, though less startling,
improvement was seen in Iowa after its ban was enacted the same year.
In fact, none of the states passing new bans on assisted suicide since
1994 have seen declines in morphine use, and several have seen dramatic
improvements.
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\12\ Assisted suicide to be R.I. felony,'' American Medical News,
Aug. 12, 1996 at 31.
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--The year after President Clinton signed the Assisted Suicide
Funding Restriction Act, banning assisted suicide in all federal health
facilities, advocates for palliative care reported that the Veterans
Administration health care system had ``made improving the quality of
its end-of-life care a top priority'' and implemented many positive
changes in this field.\13\
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\13\ S. Beckwith, ``VA Makes Better End-of-Life Care a Top
Priority,'' Last Acts Newsletter, Summer 1998 at 6.
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--After a legalization measure was defeated by popular referendum
in 1991, the Washington State Medical Association issued its first
handbook ever for rank-and-file physicians on palliative care for dying
patients. California's 1992 debate on a legalization measure, also
defeated by popular vote, was the catalyst for a 1994 ``Summit on
Effective Pain Management'' convened by the governor's office, which
led to new policy changes to facilitate the prescribing of controlled
substances for pain control (e.g., a new 1998 law ending the practice
of triplicate prescription forms). Similarly, after Michigan enacted
its ban on assisted suicide in 1998 it proceeded to enact several new
laws to encourage physicians to practice effective pain control.
There is ample evidence for the observation, made by the American
Medical Association and dozens of other medical groups in their 1997
Supreme Court brief in Quill, that ``the prohibition on physician-
assisted suicide provides health care professionals with a tremendous
incentive to improve and expand the availability of palliative care.''
\14\
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\14\ Brief for Amicus American Medical Association, et al., at 22,
Vacco v. Quill, 521 U.S. 793 (1997) (No. 95-1858).
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By the same token, as the National Hospice Organization noted in
its brief in the same case, ``the acceptance of assisted suicide as a
way to deal with terminal illness would undercut further efforts to
increase the public's awareness of hospice as a life-affirming
option.'' \15\ As Supreme Court Justice Breyer noted during oral
argument in these cases, we have certainly seen this in the
Netherlands, where hospice care is woefully underdeveloped: that
country, which permits assisted suicide, had only three palliative care
centers, compared with 185 in England which prohibits assisted
suicide.\16\
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\15\ Brief for Amicus National Hospice Organization at 18, Vacco v.
Quill, 521 U.S. 793 (1997) (No. 95-1858) and Washington v. Glucksberg,
521 U.S. 702 (1997) (No. 96-110).
\16\ Oral Arguments in Vacco v. Quill, reprinted in 12 Issues in
Law & Medicine 417, 437 (Spring 1997).
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Some may claim that Oregon is an exception to this rule, that
legalization has actually led to great improvements in hospice and
palliative care. But those claims are misleading and exaggerated, for
the following reasons:
--Oregon was a leader in palliative care long before legalization,
and almost all the alleged improvements took place before the new law
took effect in the fall of 1997. Many of these improvements were made
by Catholic and other organizations seeking to ensure that patients
would not be railroaded into assisted suicide once the objectionable
law took effect.
--Many similar improvements have occurred in states which have
passed new bans on the practice, or simply debated and then defeated
legalization measures. It is the debate itself that often focuses
lawmakers' and physicians' attention on the need to improve palliative
care.
--Whatever brief incentive this debate may have created for
improving care of the dying in Oregon now seems to be giving way to a
more ominous trend. The state of Oregon has begun to provide public
funding for assisted suicide, while cutting back on access to some pain
control drugs and other treatments for terminally ill patients; the
same trend has been observed among private health insurers in the
state.\17\
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\17\ D. Gianelli, ``Suicide opponents rip Oregon Medicaid's pain
control policy,'' American Medical News, Sept. 28, 1998 at 7; S. Rojas-
Burke, ``Health Plan cuts threaten status of safety-net clinics,'' The
Oregonian, Feb. 16, 1999; J. Hamby, ``The Enemy Within,'' The
Oregonian, Jan 21, 1998.
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--The DEA's figures on per capita use of morphine may be
instructive in this regard. Oregon has always ranked among the top
states in such use, coming in 3rd in 1992 (two years before its
legalization proposals was first approved). It rose to 2nd place in
1996, when the measure was still enjoined and assisted suicide was
still illegal. But in both 1997 and 1998, Oregon was in 6th place--
outpaced in morphine use by five states that have not legalized
assisted suicide.\18\ In 1999 Oregon was again in second place--with
first place going to New Hampshire, a state that explicitly bans
assisted suicide and has recently once again defeated a legalization
measure. These data do not provide any clear support for the claim that
legalizing assisted suicide encourages the use of drugs for pain
control; they certainly disprove the claim that prohibiting assisted
suicide discourages pain control.
---------------------------------------------------------------------------
\18\ These states prohibits assisted suicide by statute (Missouri,
New Hampshire, Arizona) or by common law (Vermont). The sole exception
is Nevada, which has no clear law on the matter. In 1998 the DEA
rankings on morphine use for the other states without a clear law were
40th (Wyoming), 48th (Utah), and 50th (Hawaii).
---------------------------------------------------------------------------
Conclusion
H.R. 2260 supports and promotes palliative care as an integral part
of good health care. It also helps prevent federal support for a
practice that is ultimately the enemy of good palliative care--the
deliberate use of medications to pervert the goals of medicine and
intentionally help cause patients' deaths. For both these reasons it
deserves support and swift enactment.
Fact sheets submitted as attachments to testimony:
1. Oregon's Ranking Among States in Per Capita Morphine Use
2. Legislative History of Federal Drug Law Supports Authority to
Act Against Physician-Assisted Suicide
3. Past Cases Show DEA Authority to Act Against Assisted Suicide
Oregon's Ranking Among States in Per Capita Morphine Use
The facts do not support a claim that legalization of physician-
assisted suicide has made Oregon a leader in use of pain medication.
Its ranking among states in per capita use of morphine was higher in
1992, two years before legalization, than in some years following
legalization.
1992--3rd highest use in the nation
1993--10th
1994--11th (year of the campaign to pass assisted suicide
measure)
1995--3rd (measure approved but enjoined by court)
1996--2nd
1997--6th (law takes actual effect in November 1997)
1998--6th
1999--2nd
These figures do not show that the morphine is used for--that is,
whether all of it is used in Oregon for pain control or some for
deliberate assisted suicides. Despite this fact, in 1997 and 1998
Oregon was outpaced in per capita morphine use by five states that have
not legalized assisted suicide. Three of these ban it by statute (New
Hampshire, Missouri and Arizona). One state (Vermont) bans assisted
suicide by common law, and one (Nevada) has no clear law on assisted
suicide.
For 1999 the ranking of the states with no clear law on assisted
suicide is: Nevada--4th; Wyoming--38th; Utah--44th; Hawaii--51st.
New Hampshire, which ranks first among states in morphine use for
1999, has repeatedly debated and rejected legalization measures in
recent years, most recently by Senate vote in February 2000.
In 1996, Iowa and Rhode Island passed new bans on assisted suicide.
Both states experienced significant increases in morphine use in the
months following enactment. Rhode Island more than doubled its rate of
morphine use in one year; such use remains about twice what it was the
year before the ban was enacted.
--Sources: Drug Enforcement Administration (for morphine data);
Americans United for Life (for survey of state law)
______
Legislative History of Federal Drug Law Supports Authority To Act
Against Physician-Assisted Suicide.
The Controlled Substances Act of 1970 was amended in 1984 to
strengthen the Drug Enforcement Administration's ability to prevent
diversion of federally regulated prescription drugs for illicit
purposes. The amendments were approved by the U.S. Senate 91-to-1 on
February 2, 1984 as part of a Comprehensive Crime Control Act (S.
1762). Almost identical language was approved by the House 392-to-1 as
a free-standing ``Dangerous Drug Diversion Control Act of 1984'' (H.R.
5656) on September 18, 1984. The House and Senate versions were
reconciled and ultimately approved as part of H.J. Res. 648, a
continuing resolution which became law on October 12, 1984 (P.L. 98-
473).
This legislative background helps answer some questions raised
about the federal government's authority to apply this federal law
against physicians who prescribe controlled substances to assist
suicides:
Was the federal law directed primarily against street drugs like heroin
and cocaine?
No, the 1984 amendments were directed specifically against the
misuse or ``diversion'' of federally regulated prescription drugs which
have a legitimate medical use. The prime House sponsor said this had
become a more serious problem in some ways than street drugs but had
``failed to get the societal or the enforcement attention that it
deserves'' (Rep. Hughes, Cong. Record, 9/18/84, H9679).
Was the law directed against physicians?
Yes, though not exclusively. ``The bill gives to DEA greater
latitude to suspend or revoke the registration of a practitioner who
dispenses drugs in a manner that threatens the public health and
safety'' (Id.). As the chairman of the House Commerce Subcommittee on
Health and the Environment said at the subcommittee hearing on this
bill: ``Today's pusher is not always a back alley salesman. He or she
may well be a highly educated health professional'' (Rep. Waxman,
Hearing of July 31, 1984, Hearing Record No. 98-168, p. 365). There
were also provisions directed at manufacturers and pharmacists.
Was the law directed against addiction, or against the use of drugs to
cause death?
The chief concern cited was their potential to cause physical harm
and death. Sponsors cited a government study indicating that
``prescription drugs are responsible for close to 70 percent of the
deaths and injuries due to drug abuse'' (Rep. Hughes, Cong. Record, 9/
18/84, H9679). The chairman of the Health subcommittee in the House
agreed: ``Drugs legally manufactured for use in medicine are
responsible for a substantial majority of drug-related deaths and
injuries'' (Rep. Waxman, Hearing Record No. 98-168, op. cit., p. 365).
One sponsor used the example of an opiate widely used as a pain-killer,
saying: ``Because these pills have an even greater potential for
physical injury and damage, they involve more than half of the hospital
entries for illegal use and overdose of drugs'' (Rep. Sawyer, Cong.
Record, 9/18/84, H9680).
Was the law designed to defer to states' judgments on the proper
medical use of drugs?
On the contrary: It was designed to give the DEA more independent
authority to revoke a physician's registration in cases where a state
refused to intervene. The 1984 amendments authorized the DEA to revoke
a physician's registration if it deems that registration to be
``inconsistent with the public interest'' (in cases where, for example,
revoking registration will serve ``public health and safety''). As Rep.
Charles Rangel said in support of the amendments: ``Under current law,
the DEA must register physicians, pharmacies, or other practitioners if
they are authorized to dispense drugs by the law of the State in which
they practice. . . . The public interest standard added by H.R. 5656
will provide greater flexibility to deny or revoke registrations in the
most egregious cases'' (Cong. Record, 9/18/84, H9682). (When a law is
enacted to prevent prescription drugs from being used for lethal
overdoses, there is nothing more egregious than a physician who
intentionally dispenses drugs for such overdoses.) Prime Senate sponsor
Strom Thurmond spoke similarly, saying that this provision ``expands
the standards for practitioner registration beyond the current
exclusive reliance upon authorization by the practitioner's own
jurisdiction'' (Cong. Record, 2/2/84, S758). Sponsors said giving such
flexibility to the federal government was necessary because states
often did not respond adequately to these abuses: ``State policing of
these activities, as well as peer review within the profession, have
not been adequate control measures. State laws regarding the dispensing
of controlled substances are also inadequate'' (Rep. Fish, Cong.
Record, 9/18/84, H9680). At a hearing before the House Subcommittee on
Health and the Environment, the DEA called the expanded federal
authority to revoke practitioner registration ``one of the most
important sections of the bill,'' not only because states were often
ill-equipped to enforce their own drug laws but also because ``many
controlled drug violations involving prescription drugs are not
felonies under state law and therefore cannot be used in a DEA
revocation action'' under then-existing law (Testimony of Gene R.
Haislip, Deputy Assistant Administrator, Drug Enforcement
Administration, Hearing Record No. 98-168, p. 404). Congress's view was
that while the states are the first line of defense against misuse of
prescription drugs, the federal government must enforce its own
objective standard as to what constitutes such misuse--and it must have
the authority to enforce that standard when a state cannot or will not
do so.
In light of this history, it cannot be maintained that the
Controlled Substances Act as it exists today was directed only against
professional drug traffickers rather than physicians, or only against
addition rather than lethal drug overdoses, or only against physicians
who violate state laws. Independent federal authority to enforce
federal drug standards was intended to apply to ``Schedule II''
prescription drugs like barbiturates or morphine as much as to
``Schedule I'' drugs like marijuana or cocaine--most especially when
such drugs are being used to cause death.
______
Past Cases Show DEA Authority To Act Against Assisted Suicide
Currently, practitioners run afoul of the federal Controlled
Substances Act if their actions cause or contribute to the use of
federally regulated drugs for fatal or near-fatal overdoses. In one
recent case, a doctor was denied a DEA registration because he gave
potentially lethal drugs to a depressed patient who he should have
known might well use them for suicide. The following list of cases from
the Federal Register is far from exhaustive:
1. 60 FR 56354 (Nov. 8, 1995): Case of Dr. Hugh Schade: The doctor
was neglignt because he gave potentially lethal amounts of Darvocet to
a depressed patient who used them to commit suicide. Giving these drugs
to a patient in this mental state, said one expert witness, was ``like
handing him a loaded gun.'' While Dr. Schade was also convicted of
negligent homicide under state law because of this case, his DEA
application was denied not on the basis that he had violated a state
law [21 USC Sec. 823(f)(3)], but on the separate basis that his conduct
objectively threatened ``public health and safety'' [21 USC
Sec. 823(f)(5)].
2. 62 FR 16189 (April 4, 1997): Case of Dr. Jose R. Castro: Here a
patient died of a drug overdose using controlled substances which the
doctor prescribed ``for no legitimate medical reason.'' The doctor had
lost his state license to prescribe controlled substances on this
basis, so it was automatic that he lost his federal registration as
well; there was no need to apply the ``public health and safety''
standard independently.
3. 49 FR 6577 (February 22, 1984): Case of Dr. Samuel Fertig: A
physician was denied a DEA registration because he had prescribed
massive quantities of controlled substances to several young people who
used them in lethal overdoses. Acknowledging that the physician had
been restored to full medical licensure in his state, the DEA
Administrator nonetheless ruled that the physician ``was responsible,
directly or indirectly, for the deaths of several young people'' (49 FR
at 6579) and hence that the application must be denied to protect
``public health and safety.''
4. 63 FR 8477 (February 19, 1998): Case of Townwood Pharmacy: A
woman reported to the DEA that her daughter, who had a drug problem,
had overdosed several times using drugs from this pharmacy. From the
notice it is clear that if this was proved, it would have counted
against the pharmacy under the ``public health and safety'' standard;
but there was no clear evidence that the woman obtained the drugs from
this pharmacy. The pharmacy's registration was revoked on other
grounds.
5. 55 FR 5306 (Feb. 14, 1990): Case of Dr. Murray J. Walker, Jr.:
This physician prescribed Percodan for non-medical purposes to several
people; one woman died of a drug overdose. Her boyfriend then
cooperated with investigators because he believed the physician ``was
responsible for the woman's death'' (55 FR at 5306). In revoking the
physician's registration the DEA noted: ``Substances are controlled
because they are potentially dangerous and therefore should be handled
with extreme care. Respondent has failed to exercise such care and, as
a result, has ignored his duties as a health care professional to
protect the public health and safety from the illicit use of these
drugs'' (Id. at 5307).
6. 55 FR 4250 (February 7, 1990): Case of Dr. Rodrigo I. Ramirez:
While conducting an unauthorized treatment program for drug addicts,
this physician issued a prescription for large quantities of Dolophine
and Xanax to a patient who died the next day from an overdose. The
Oklahoma Medical Board suspended his state registration to prescribe
certain controlled substances, but later reinstated him under
supervision. The DEA concluded that he had ``prescribed controlled
substances without medical need and in excess of the amount considered
good medical practice'' (55 FR at 4252). Despite the physician's
argument that he had been sufficiently punished under state law, the
DEA revoked his federal registration, saying: ``The Administrator
cannot and will not in all cases rely on state authorities to monitor
and regulate a registrant holding a DEA controlled substances
registration where there is evidence that the registrant has violated
Federal law and has demonstrated conduct which may further threaten the
public health and safety'' (Id. at 4252).
7. 45 FR 61047 (September 15, 1980): Case of Dr. Joyce E. Millette:
This physician supplied controlled substances to many drug addicts,
including one man who used the drugs in a lethal overdose and a young
man who was rendered unconscious by an overdose. The second young man's
father, a dentist, testified that the physician ``had prescribed drugs
without adequate knowledge of the condition or medical background of
the patient, in strengths and amounts which could have brought about
dependency and possible death'' (45 FR at 61048). At least two other
potentially fatal drug overdoses were attributable to drugs the
physician had prescribed. The DEA noted: ``A DEA registration carries
with it enormous potential for harm. Controlled substances, properly
administered or prescribed, may be very useful in the course of medical
treatment. Improperly used, they have the potential for dependency,
addiction and even death'' (Id. at 61048). Revoking the physician's
registration, the DEA noted that ``several overdose incidents and at
least one death were attributable to the controlled substances she
prescribed. The Administrator finds it hard to conceive of a more
compelling case for revoking a registration or denying an application''
(Id. at 61049). The Administrator also expressed regret that the law at
that time did not allow for effective DEA action prior to a physician's
``prosecution and conviction'' under state law, noting: ``In a case
such as this, such a procedure might conceivably have saved lives''
(Id. at 61049). [Four years later the DEA received such authority from
Congress to revoke registrations independently of whether state law had
been violated.]
8. 51 FR 5422 (February 13, 1986): Case of Dr. Rex A. Pittenger:
This physician ``prescribed numerous controlled substances for no
apparent legitimate medical reason.'' After one patient died of a drug
overdose, he was convicted of involuntary manslaughter and other
felonies in one state and lost his medical license in another; on these
grounds both his DEA registrations were revoked.
9. 48 FR 49937 (October 28, 1983); 54 FR 53382 (December 28, 1989):
59 FR 6297 (February 10, 1994): Case of Dr. David W. Bradway: This
physician's registration was revoked after he was convicted under state
law on various counts, most notably ``one count of manslaughter by
unlawfully distributing controlled substances in such a grossly
negligent [and] reckless manner as to cause the death of an
individual'' (48 FR at 49937). Years later, after allegedly
rehabilitating and resuming medical practice, the physician applied for
a new DEA registration; citing the fact that ``a death was directly
attributable to Respondent's misuse of his DEA Certificate of
Registration,'' the DEA denied the application, stating: ``it is the
position of the DEA that a Certificate of Registration to handle
controlled substances is a privilege, not a right, and it should only
be granted to doctors who have demonstrated high standards of ethical
conduct and who are completely trustworthy in handling dangerous
controlled substances which, as can be seen in this case, can have a
devastating impact on individuals who abuse them'' (54 FR at 53384). In
1992, again applying for a DEA registration, the physician ``testified
with great sincerity and obvious pain concerning the remorse and regret
that he felt about the events leading to the individual's death'' and
submitted a psychiatric report and further evidence of rehabilitation
(59 FR at 6298). However, due to ``the egregious nature of Respondent's
past conduct,'' the DEA ruled in 1994 (15 years after the patient's
death) that ``the registration of the Respondent is still not in the
public interest'' (Id. at 6299).
10. 55 FR 37579 (September 12, 1990): Case of Dr. Pompeyo Q. Braga
Bonado: The DEA found that granting a registration to this physician
would be ``clearly contrary to the public interest.'' 55 FR at 37580.
The physician had prescribed controlled substances to several
individuals ``for no legitimate medical purpose,'' including one man
addicted to Percocet who was hospitalized after a suicide attempt. ``As
a health care professional and DEA registrant,'' the DEA noted,
``Respondent bears a heavy responsibility to ensure that the controlled
substances he prescribes are not abused.'' Id. at 37580.
11. 59 FR 46063 (September 6, 1994): Case of Dr. John W. Copeland:
This pyhsician's registration was revoked because he had prescribed
Ritalin and other drugs to many addicted persons without a legitimate
medical need. One patient obtained anabolic steroids from the physician
after revealing that he had taken them in the past, was depressed and
had attempted suicide ten months earlier, a medical expert testified
that it is ``medically dangerous'' to give anabolic steroids to a
patient with prior depression. The DEA found that the physician's
continued registration was contrary to the public interest, in part
because his actions endangered public health and safety.
Several of these cases illustrate two points. First, in judging
whether continuing a registration will serve the ``public interest,''
the DEA may assess whether the registrant's practice threatens ``public
health or safety'' independently of whether he or she can be shown to
have violated state law. Second, while the absence of a state license
automatically means that the federal government will issue no license,
the converse is not true--that is, ``state licensure is a necessary but
not sufficient condition for DEA registration'' (63 FR at 8479 [Feb.
19, 1998]). Under current law, DEA registration requirements do not
depend solely upon the policies of individual states.
--R. Doerflinger, 4/20/00.
Prepared Statement of the National Right to Life Committee
The National Right to Life Committee strongly supports passage of
the Pain Relief Promotion Act, a bill to ban the use of federally
controlled drugs to kill patients.
This bill would most appropriately show that the federal government
favors helping vulnerable people, not having them kill themselves. The
National Right to Life Committee believes that you do not solve
problems by getting rid of the people to whom the problems belong.
The pro-suicide movement talks about autonomy. Years of experience
in the Netherlands and now the writing from the US euthanasia movement
show that assisted suicide and euthanasia are about anything but
autonomy. Assisted suicide is about getting rid of people who are
inconvenient or costly. Even when no outside pressure is put on people
who are very sick or disabled, the legalization of assisted suicide
carries with it an implicit burden, creating a feeling of guilt on
those who feel they are imposing on their loved ones. Assisted suicide
is the ultimate abandonment.
People who are ill need our compassion and care. Laws against
assisted suicide provide a safety net for people who are potential
victims of greedy insurance companies, weary families or simply their
own depression that prevents them from seeing the value of their lives.
Depression can be treated, pain can be controlled, and many
organizations and support groups are ready to help patients and their
families through difficult times. It is tragic that the people in
Oregon who were killed with the assistance of their doctors, with the
permission of their state, and with federal drugs, will never have the
benefit of those life-affirming alternatives.
The Attorney General, Janet Reno, was wrong in overriding federal
drug law in order to provide access to narcotics and dangerous drugs to
doctors who want to help kill their patients. We are so grateful that
the House of Representatives has acted to reverse that ruling and now
the Senate stands poised to do the same. We applaud the Members of both
Houses who view assisted suicide as desertion and who are working to
provide even better access and education in the area of pain control.
The compassionate answer to people who are ill is to expand the
safety net of care and protection and to extend more emotional and
psychological support. The answer of Derek Humpry and other suicide
proponents is to discard those who don't meet some arbitrary standard
of worth or who are deemed ``too burdensome.''
__________
Prepared Statement by the Oncology Nursing Society
The Oncology Nursing Society (ONS) is the largest oncology group in
the United States composed of over 29,000 nurses dedicated to improving
the care of oncology patients and oncology health services. ONS has
serious concerns and reservations about The Pain Relief Promotion Act
in that it could inadvertently harm patients with cancer who have
severe pain and require supportive care.
Many patients with cancer require extremely large doses of pain
medications to assure that they are comfortable and can maintain a good
quality of life and interaction with their family. These seemingly
large doses are not prescribed to assist in a suicide but to assure
good pain control and quality cancer care. ONS does not endorse the
practice of physician assisted suicide.
ONS has following concerns regarding The Pain Relief Promotion Act:
The legislation would give Drug Enforcement Administration
(DEA) agents the explicit authority to question the intent of any
physician or medical practitioner who provided a controlled
substance to a patient who died shortly thereafter.The line between
increasing the risk of death while treating pain (an allowable
medical practice) and intentionally causing death (a crime with
severe penalties) is a very fine one. To have the DEA make this
distinction may harm pain management.
Since at least 1990, the DEA has accepted the ``double
effect'' aspect of pain care--the recognition that aggressive pain
relief may have the secondary effect of hastening a patient's
death. Therefore, it is not necessary to formalize this policy in
statute, and doing so is certainly not worth the price of expanding
the DEA's role. What is needed is not a new law, but better
implementation by the DEA of existing policy on ``double effect''
and better education of physicians and other providers in the use
of opioids.
Raising the burden of proof on the DEA to ``clear and
convincing evidence'' as provided in the Hatch Substitute is an
attempt to reassure practitioners, but making a physician's
internal mental intent in prescribing medication subject to
external second-guessing by any standard of proof could be
chilling.
As more provisions are added to the Controlled Substances Act
under the substitute amendment, there is more potential for
ambiguity affecting all parties involved.
More training for physicians and other healthcare providers is
needed. The bill authorizes only $5 million for this--less than $0.10 a
person for the over 50 million Americans who suffer from chronic pain--
and even that insignificant amount may never be appropriated by
Congress.
Legislation that attempts to assure adequate pain control and
supportive care for patients who have severe pain and are terminally
ill requires the assurance of quality pain care and support programs.
ONS continues to have serious concerns regarding the final effect this
legislation could have for our patients if passed into law.
__________
Prepared Statement of Pain Care Coalition
The Pain Care Coalition is pleased to present this statement in
connection with the Committee's consideration of H.R. 2260, The ``Pain
Relief Promotion Act of 199.'' The Pain Care Coalition is a national
coalition that advocates for responsible pain care policies at the
federal level. The Coalition was formed in 1998 by concerned
organizations representing the interest of pain care professionals and
their patients. Constituent members of the Coalition represent a broad
spectrum of physicians and other health care professionals involved in
the diagnosis and treatment of patients suffering from acute and
chronic pain. Members also include those professionals who conduct
biomedical and related research into the causes of pain and the
effectiveness of diagnostic and therapeutic approaches to freeing
patients from pain or lessening the pain of those who must live with
it.
The Coalition appreciates the Committee's interest in the issue of
pain care. Pain is a major public health problem in this country. It
effects people of all ages and at every stage of life. It is generally
recognized that throughout the nation, and regardless of age, setting,
or health status, severe pain is often under-treated or mistreated, if
not overlooked entirely. Nine out of ten Americans experience some sort
of pain on a regular basis--monthly or more often. Fifty million
Americans are partially or totally disabled by pain, and 46 percent of
all Americans seek care for persistent pain at some point in their
lives. Pain imposes a tremendous burden on these individuals and their
families.
Pain also imposes a tremendous burden on the economy, and upon the
heath care system. 27 percent of American workers have missed work in
the past year due to pain. For example, migraine alone affects 24
million people, the majority of them women in their 30's and 40's. This
one painful disease alone leads to 157 million lost workdays each year
at a cost to economic productivity estimated at over $17 billion. Costs
attributable to low back pain are even higher, and the total cost of
pain to the economy is now estimated at over $100 billion.
Pain accompanies a wide range of other clinical conditions such as
cancer, heart disease and arthritis, among many others. This form of
pain, referred to as ``secondary'' pain, requires treatment, as does
the condition from which it arises. This pain is called ``secondary''
pain, because it is a symptom of the other condition or disease.
``Primary'' pain is when the brain or spinal cord themselves generates
the pain, and no other condition is responsible for it. Pain, whether
primary or secondary, requires aggressive and state of the art
treatment. However, evidence abounds that neither primary nor secondary
pain is adequately treated in this country. Recent studies of end-of-
life care in hospitals, of the elderly in nursing homes, and of the
general public in Michigan all reach the same conclusion: many, many
people endure unnecessary suffering due to inadequate pain care.
Several bills addressing pain care issues in some manner have been
introduced in this Congress. The Pain Care Coalition welcomes these
initiatives as an important reflection of the growing awareness of and
concern for pain as a public health priority in this country, and among
policy-makers at the federal level. One of those proposals, the Pain
Relief Promotion act, has been particularly controversial since its
original introduction in 1998. The Pain Care Coalition was among many
groups to express reservations about the bill then, and more recently
about the revised version of the legislation which passed the House
last fall.
These reservations have focused on concerns that the bill might
have a ``chilling effect'' on the willingness of physicians to
prescribe controlled substances for legitimate pain control purposes,
particularly to patients at or near the end of life. These concerns
have been based in part on confusion over whether the bill actually
grants new authority to the Drug Enforcement Administration to police
physician prescribing practices, and in part on fears that enactment of
the legislation might influence the DEA's use of its existing authority
under the Controlled Substances Act.
Given these reservations about the House-passed bill, the
Coalition, working with other interested organizations, has advocated
for certain modifications to the bill to ensure that appropriate--and
indeed sometimes aggressive--pain care would not be compromised by the
fear of overzealous DEA scrutiny.
The Coalition is pleased to advise the Committee that these
concerns have been heard, and that the Chairman's proposed substitute
for the House-passed bill incorporates important changes that the
Coalition strongly supports. On the basis of those changes, the
Coalition urges all members of the Committee to support the Chairman's
substitute.
First, by raising the standard of proof in certain DEA
administrative proceedings to that of ``clear and convincing''
evidence, the substitute would ensure that whatever new law is made by
this bill, if any, could be used against physicians only in the most
clear cut cases, and not simply because ``20/20 hindsight'' raises
suspicion about a physician's intentions in prescribing controlled
substances to terminally ill patients.
Second, and of equal or greater importance in the long run, are
beneficial changes in the bill's new initiatives to further education
and training in appropriate pain care, including the legitimate use of
controlled substances. By broadening these new authorities to include
pain care generally, and not just palliative care at the end of life,
the substitute ensures that the use of controlled substances will be
viewed in context with the other diagnostic and therapeutic options
available in this rapidly maturing field of medicine. To equate pain
care only with the needs of the dying, or to promote the use of
controlled substances while ignoring other more appropriate modalities
would have been a disservice to millions of Americans who suffer daily
from pain that is not related to terminal illness, and for which
controlled substances are neither the most appropriate nor the most
effective treatment.
Finally, the Coalition applauds that provision of the Chairman's
substitute which declares the next ten years to be the ``Decade of Pain
Control and Research.'' Despite its prevalence as a leading health
problem, pain has often been a largely invisible condition. It lacks a
significant constituency at the Federal level, and this has contributed
to serious under-investment in research and treatment in the pain
field. A congressionally declared ``Decade'' will bring a much needed
focus on pain in both the public and private sectors. It can be an
important first step in stimulating further progress in research,
training, and clinical care.
For all of these reasons, the Coalition is pleased to endorse the
Chairman's substitute to H.R. 2260. While some well-intentioned critics
may still fear the ``chilling effect'' of any legislation to be
implemented, even in part, by the Drug Enforcement Association, the
Pain Care Coalition is persuaded that the substitute will not impede
the legitimate use of controlled substances by the vast majority of
pain care practitioners who will remain committed to providing
appropriate pain and palliative care to terminal and other painful
patients who, without such care, might be driven to consider the taking
of their own lives.
The Pain Care Coalition applauds the Committee for its commitment
to protecting patients in pain, and for focusing badly needed attention
on issues affecting pain care policy at the Federal level. The
Coalition welcomes the opportunity to work with interested members of
Congress to advance legislative proposals that promote appropriate pain
care--care that is increasingly available to reduce needless suffering
throughout the population.
__________
Prepared Statement of Physicians for Compassionate Care
summary statement
Physicians for Compassionate Care, an organization providing
education about pain relief and palliative care, urges passage of the
Pain Relief Promotion Act. This testimony to the U.S. House Judiciary
Subcommittee on the Constitution, June 24, 1999. This new information
falls into two categories. First, since hearings last June, the
American Medical Association held intensive and comprehensive
discussions before its entire House of Delegates, including
representatives from the whole field of medicine. These meetings and
subsequent negotiations thoroughly addressed all concerns raised by
detractors of the Pain Relief Promotion Act. Second, new examples of
the misuse of federally controlled substances for assisted suicide and
euthanasia in Oregon have surfaced. These cases reveal failure to
protect the mentally infirm and those under pressure from their
families, involvement of health maintenance organizations in assisted
suicide, failed assisted suicide attempts, and involuntary euthanasia
in the hospice setting. These abuses make it increasingly clear that
allowing the use of federally controlled substances for assisted
suicides constitutes a public danger.
any legitimate medical concerns about the pain relief promotion act
have been addressed
Widespread agreement exists, even among those not initially
favoring the Pain Relief Promotion Act (PRPA), that funding for
improved education and research about pain treatment and palliative
care is much needed. Yet, while admitting that assisted suicide is not
a medical procedure, that it constitutes a public danger, and that it
should not be allowed, some detractors of the Pain Relief Promotion Act
still claimed last fall that this bill might create new authority for
the Drug Enforcement Agency (DEA) and might create new penalties for
physicians, thereby having hypothetical ``chilling effect'' on the
provision of pain treatment and palliative care. A second concern
raised by some critics of the PRPA was that it might somehow alter the
balance of federal and state authorities in the regulation of
controlled substances and the practice of medicine. Aggressive
promotion of such fears by those favoring assisted suicide led to
further consideration by the American Medical Association (AMA) of its
position supporting the PRPA. This time, the discussion took place in a
full debate of the entire House of Delegates--the highest decision
making body of the organization--resulting in clear reaffirmation of
support for the Pain Relief Promotion Act. Physicians for Compassionate
Care played a prominent role in these discussions. Reaffirmed support
was followed by the negotiation of and agreement upon proposed new
wording to reassure those few remaining critics that the Pain Relief
Promotion Act creates no new authority of the DEA and does nothing to
alter the role of the federal and state governments in the regulation
of controlled substances.
The House of Delegates of the AMA, in that it has representatives
from virtually all specialty societies and numerous other medical
groups, both large and small, as well as from the state medical
societies, represents 95% of practicing physicians in America. Even
physicians who are not delegates to the AMA can have their voices heard
at this meeting. Among all those who testified, there were no concerns
about the Pain Relief Promotion Act raised other than these two--fear
of a theoretical ``chilling effect'' and speculation about role of
federal and state government in the regulation of the practice of
medicine.
Data presented at those meetings and among physicians across the
country made it abundantly clear that those few states that have
enacted laws similar to the Pain Relief Promotion Act showed no
``chilling effect.'' On the contrary, per capita use of morphine,
increased. In Rhode Island, for instance, the per capita morphine use
more than doubled after a similar law was passed. While per capita
morphine use figures do not accurately reflect the adequacy of pain
treatment, they do reflect levels of physician comfort in prescribing
controlled substances. Close examination of the PRPA also showed that
fears of new penalties were entirely unfounded, because the Pain Relief
Act creates no new penalties. In fact, it provides new protection for
physicians against existing penalties by making it perfectly clear, for
the first time, what has always been true in medicine--that aggressive
pain management can be appropriate medical care even if in rare
instances it might inadvertently increase the risk of death. It was
also pointed out that wording had already been read into the record of
the United States Congress by the authors of the Act last fall,
clarifying that the PRPA is not intended to create any new authority
for the DEA. This careful examination of available data and of the Act
itself showed that the fears of any possible ``chilling effect'' were
entirely unfounded.
While it became very clear that the Pain Relief Promotion Act
provided new protections for both physicians and patients, a few
continued to harbor doubts concerning the roles of the federal and
state governments. These concerns were addressed through lengthy
discussions and the proposal of additional wording that clarifies that
the Pain Relief Promotion act shall not be interpreted to alter the
balance of the state and federal governments in the practice of
medicine and the regulation of controlled substances. Now, the
remaining few critics of the bill have been reduced to somewhat
inconsistently arguing both that the Pain Relief Promotion Act may not
give doctors enough protection and that it may give them too much
protection. Careful consideration by the deliberative bodies of the
field of medicine, however, have determined that a proper balance,
which optimally protects both doctors and patients, has been achieved.
Virtually all the issues and fears raised now have been thoroughly
studied and discussed and addressed with due deliberation to the
satisfaction of the vast majority of physicians, even among those who
initially may have harbored any concerns. The important details have
been carefully addressed and settled. Yet, in the meantime, innocent
patients in Oregon have continued to die untimely deaths through the
administration of lethal doses of federally controlled substances using
federal DEA licenses, instead of for appropriate pain treatment and
palliative care. How many more American citizens will be given deadly
doses of federally controlled substances using federal DEA licenses,
before this enlightened piece of legislation is enacted, clarifying
that federally controlled substances are to be used for pain treatment
and palliative care, not for lethal overdoses?
new cases confirm the public danger of assisted suicide
No Protection for the Mentally Infirm
Previous testimony (June 24, 1999) by Physicians for Compassionate
Care demonstrated how allowing the use of controlled substances for
assisted suicide led to the first publicly reported case of legalized
assisted suicide in Oregon being given a lethal overdose instead of
treatment for her depression, despite the well documented fact that she
had been diagnosed as depressed. Since that time, another case, this
time a woman with dementia under pressure from her family was given
assisted suicide by her health maintenance organization (HMO) doctor
using federally controlled substances.
Mrs. Kate Cheney was an elderly, Oregon woman with growing dementia
and the diagnosis of a potentially terminal cancer (Barnett, 1999;
Smith, 1999; Hamilton, 2000). When her daughter accompanied her to her
doctor's appointment to formally request assisted suicide, the doctor
did not agree with that course of action. It was the daughter (Barnett,
1999), not the patient, who then insisted the mother have a new doctor
within her HMO, Kaiser Permanente. The doctor change for the mother was
granted to the daughter.
This second doctor was willing to give Mrs. Cheney assisted suicide
and arranged for psychiatric for evaluation, because it was standard at
this HMO in its assisted suicide procedure. The psychiatrist, who
released a written report to the newspaper, found that Mrs. Cheney had
short-term memory deficits and dementia. The assisted suicide request
appeared to be the daughter's ``agenda'' (Barnett, 1999). The daughter
who also accompanied Mrs. Cheney to this appointment, ``coached her''
in her answers, even when the psychiatrist asked her not to do so.
Concerning the patient, the psychiatrist observed, ``she does not seem
to be explicitly pushing for this'' (Barnett, 1999). She was deemed
lacking sufficient capacity to weigh options about assisted suicide;
thus, she was not eligible for doctor-assisted suicide.
The patient accepted this assessment. Her daughter, however,
``became angry'' (Barnett, 1999). It was the daughter, not the patient,
who then ``decided on a second competency evaluation'' (Barnett, 1999).
Kaiser HMO apparently authorized this second off-panel mental health
evaluation. This new psychologist admitted the patient could not even
remember when she was diagnosed with terminal cancer, although it had
only been within the last three months. She also wrote that the
patient's ``choices may be influenced by her family's wishes and her
daughter, Erika, may be somewhat coercive'' (Barnett, 1999).
Nevertheless, she approved the assisted suicide.
With two conflicting mental health opinions, the final decision
came down to yet another Kaiser HMO doctor-administrator, Robert
Richardson, who approved giving a lethal overdose to this elderly woman
under pressure from her family. Kaiser Permanente is a fully capitated
HMO with a profit sharing plan for its doctors. Dr. Richardson may or
may not have directly thought of the economic advantages to his
organization and his own profit sharing plan in making his decision
about Mrs. Cheney. Nevertheless, the existence of an economic incentive
program put in place purposefully to induce doctors to reduce medical
costs, an incentive system that in this case favored doctor-assisted
suicide over expensive medical care, did exist and should be noted.
The problems with this well documented case in Oregon (Barnett,
1999; Smith, 1999; Hamilton, 2000) were not reported in the Oregon
Health Division (OHD) report (Sullivan et al., 2000). And psychiatric
evaluation served no protective function for her, since an opinion
protecting her against assisted suicide, merely prompted her daughter,
not the patient, to search for another opinion.
Outside pressure or influence for assisted suicide is not at all
uncommon, once assisted suicide becomes legalized. In fact, in the
Netherlands, over half the doctors feel it is fine to actually suggest
to a patient who has not requested it that assisted suicide may be
appropriate for them (Hendin et al., 1997). Numerous cases of patients
under family pressure to commit assisted suicide have been recorded in
the Netherlands (Canady, 1996). As the Cheney case illustrates, these
kinds of pressures are already in Oregon. For those and other reasons,
use of federally controlled substances for assisted suicide presents a
public danger.
Assisted Suicide Inevitably Expands to Include Involuntary Euthanasia
Five seriously ill patients in Sheridan, Oregon, hospice were given
excessive doses of a federal controlled substance, morphine, by Michael
J. Coons, between November 1977 and January 1998, just after the Oregon
assisted suicide law was implemented, according to criminal
investigators (Tims, 2000a). The overdoses resulted in the deaths of
four of the five patients. Some patients were determined by
investigators to have refused pain medication and were given it
nonetheless. Another was given repeated narcotic doses when he was
unconscious or unresponsive (Tsao, 2000). The one woman who survived
had been placed on hospice, which meant that she had been determined to
be ``terminally ill'' and to have less than six months to live, by the
nurse who eventually gave her a life threatening overdose. She turns
out not to have met criteria for ``terminal illness'' after all,
because two years later, she is still alive. Her experience with the
attempts to kill her with a lethal overdose of federally controlled
substances, however, have undermined her trust in the medical care
system and at night she now makes sure the door to her room is always
locked (Tims, 2000b). The other four patients did not live to struggle
with their fears.
In Oregon, where the lives of the seriously ill have been devalued
by the acceptance of giving some patients deadly overdoses of federal
controlled substances, there was an inordinate delay in the
investigation of these cases. Complaints were dismissed by agency after
agency, until the persistence of the daughter of one of the victims,
finally succeeded, one-and-a-half years later, in demanding an inquiry
(Tims, 2000b). The daughter of the single survivor said she did not
know about the overdose of her mother until it was published in the
newspaper, two years later. She was outraged (Tims, 2000a).
Erosion of the conditions of trust in the doctor-patient
relationship has already begun in the state of Oregon, as has already
happened in the Netherlands. While some supporters of legalized
assisted suicide using federally controlled substances might wish to
argue that the overdosing of these five hospice patients was an
aberration resulting from a single deranged individual's action, there
is considerable statistical evidence to the contrary. Once assisted
suicide using controlled substances is allowed in some circumstances,
individual medical personnel increasingly interpret that acceptance as
approval of other kinds of killing in the medical setting.
In the Netherlands, where doctor-assisted suicide has been allowed
longer than in Oregon, it has been clearly demonstrated that killing in
the medical setting moves from doctor-assisted suicide to active
euthanasia, form the terminally ill to the chronically-ill, from
voluntary to non-voluntary (Canady, 1996). For each voluntary assisted
suicide in the Netherlands, there are more than twice as many cases of
involuntary euthanasia. As the U.S. Supreme Court observed,``The Dutch
government's own study revealed that in 1990, there were 2,300 cases of
voluntary euthanasia (defined as 1the deliberate termination of
another's life at his request'), 400 cases of assisted suicide, and
more than 1,000 cases of euthanasia without an explicit request. In
addition to these latter 1,000 cases, the study found an additional
4,941 cases where physicians administered lethal morphine overdoes
without the patient's explicit consent'' (U.S. Supreme Court, 1997). It
is not surprising, then, that such expansion of assisted suicide using
federally controlled substances to the area of involuntary euthanasia
is already becoming apparent in Oregon.
State Monitoring is Ineffective
The Oregon Health Division (OHD) review of 1998 reported cases of
assisted suicide, all of whom received lethal overdoses of federally
controlled substances, was particularly criticized because of ``its
failure to address the limits of the information it has available,
overreaching its data to draw unwarranted conclusions'' (Foley and
Hendin, 1999). The report's declaration of a lack of problems was
clearly unwarranted. The first publicly reported case of assisted
suicide was noted to have been diagnosed with depression, yet the
report failed to reveal this fact. Neither did the report mention that
same woman mentioned that concerns about finances were one motivating
factor in her decision for assisted suicide. The OHD apparently
overlooked those problems and other problems, because it only
interviewed the doctors who prescribed the lethal drugs and who
therefore had a vested interest in justifying their recent behavior.
Since that time, OHD has issued a second report (Sullivan et al.,
2000) with similar unwarranted reassurances based upon similar
methodological shortcomings (Hamilton, 2000). This year, the OHD also
interviewed some family members, but those family members were chosen
by the assisted suicide doctors themselves and were also motivated to
justify their recent behavior. The patients themselves were never
interviewed by OHD prior to their being given overdoses of controlled
substances; nether were the medical records systematically examined,
with due consideration for patient confidentiality, by outside
researchers.
There is solid evidence that not all the cases were reported. At
least one assisted suicide attempt resulted in such disturbing symptoms
that the family called 911 (Hamilton, 2000). The patient was taken to
the hospital and resuscitated. This case apparently was never reported.
This instance when a known failed assisted suicide case was not
reported suggests that there is skewed reporting with complications
being hidden. Assisted suicide and euthanasia advocate, Dr. Sherwin
Nuland (2000) cast doubt on the credibility of the Oregon report when
he observed that a Dutch report in the New England Journal of Medicine
indicated 18% of assisted suicide attempts needed to be ended with
lethal injection, usually due to complications (Groenewoud et al.,
2000), yet the OHD insisted it has yet to find a complication.
The OHD also failed to mention documented dementia in the Kate
Cheney case, similar to its failure to mention the diagnosis of
depression in the first publicly reported case that should have been
discussed in the first report. It did not mention known multiple or
conflicting mental health opinions. It only mentioned that 10 of 27
cases were referred for such evaluations, but said nothing about the
results.
Neither did the OHD report that there were any instances of family
pressure or coercion, despite the fact that two mental health
professions were known to have found such factors present in the Kate
Cheny case. It is not known in how many other cases such pressures may
have played a part.
Concerning the issue of economic pressures, OHD only asserted that
all the assisted suicide cases were insured. It provided no information
about what the financial arrangements of the insurance companies might
be. It did not mention the capitated and profit sharing plan of Kaiser
HMO where Mrs. Cheney died. It did not mention the rationing of health
care and the barriers to mental health care in the Oregon Health Plan
(described in previous testimony, June 24, 1999) and upon which four
cases had to rely. And, it said nothing about how many patients
belonged to HMOs which put limits on payments for in-home palliative
care at very low amounts, yet fully fund assisted suicide, as Qual Med
HOMO is reported to do. Instead of gathering useful information, the
OHD once again overreached its data and provided unsubstantiated
reassurances.
The inability to monitor and control assisted suicide using
federally controlled substances with federal DEA registrations, once it
is legalized, further demonstrates the public danger of allowing use of
federally controlled substances for giving lethal overdoes to American
citizens
Assisted Suicide Expands to Include Legalized Lethal Injection
In previous testimony, the case of Patrick Matheny's failed
assisted suicide attempt was described. Mr. Matheny was a man with
amyotrophic lateral sclerosis (ALS), who received through the mail a
huge quantity of barbiturates prescribed by an assisted-suicide doctor
(Barnett 1999). After two attempts at swallowing the contents of the
large number of capsules failed, because of his medical condition, his
brother-in-law said he ``helped'' him die and complained that Oregon's
suicide law discriminates against those who cannot swallow. The body
was cremated within a day; consequently, no autopsy could ascertain the
cause of death. Doctors and other citizens demanded that the prosecutor
investigate the death, because illegal suffocation of the patient has
been the most frequent method of ``helping'' patients die when assisted
suicide attempts fail.
In response to inquiry, Oregon's Deputy Attorney general issued an
opinion indicating that lethal injection may need to be accepted once
assisted suicide is accepted, because Oregon's assisted suicide law
does not provide ``equal access'' to its provisions by disabled people
who cannot swallow and may violate the Americans with Disabilities Act.
The important legal implication of such failed assisted suicide cases
is that they are bound to bring in lethal injection. That is what has
happened in the Netherlands (Canady, 1996; Hendin et al., 1997). That
is the dilemma prominent euthanasia proponent, Dr. Sherwin Nuland
(2000), raised in the New England Journal of Medicine--if doctors are
going to start carrying out assisted suicides, they will need lethal
injection to finish the job--and lethal injection clearly gives power
and control to doctors, nurses, and health care systems, not to the
patient. And that is what is being brought up already by Deputy
Attorney General David Schuman in Oregon.
The United States Supreme Court, as discussed in its 1997 decision,
Washington et al. v. Glucksberg, stated ``. . . it turns out that what
is couched as a limited right to `physician assisted suicide' is
likely, in effect, a much broader license, which could prove extremely
difficult to police and contain.'' The inevitable progression to lethal
injection, which occurred in the Netherlands, is already occurring in
Oregon.
conclusion
The need for improved education and research to promote pain and
palliative care is overwhelming. The Pain Relief Promotion Act makes
provision for improving such education and research about pain
treatment and palliative care. It clarifies to physicians, nurses, and
state medical boards, as well as to law enforcement personnel, that
provision of pain medicine is a legitimate medical practice, even if in
rare instances there may be an added risk to a patient's life. Since
previous testimony presented by Physicians for Compassionate Care, June
24, 1999, any legitimate concerns about a hypothetical ``chilling
effect'' or change in the balance of federal and state jurisdictions in
dealing with controlled substances have been alleviate.
During the same time interval, patients in Oregon have continued to
die untimely deaths, being given lethal overdoses of federally
controlled substances instead of pain treatment and palliative care
they deserve. There has been the revelation of yet another case of a
mentally infirm woman not being protected against assisted suicide in
an HMO and under pressure from her family. There have been reports of
assisted suicide expanding to the practice of involuntary euthanasia in
the case of hospice patients. And there have been failed assisted
suicide attempts, resulting in a call for introduction of more sure
methods of ending the lives of vulnerable patients, that is, lethal
injection. These cases and the failure to report any of these
documented tragic cases in official reports make it clear that allowing
the use of controlled substances for assisted suicide creates a public
danger.
There already have been too many deaths of American citizens caused
by overdosing vulnerable patients with dangerous federally controlled
substances. It is time to stop the killing of American citizens using
federal DEA registrations to prescribe federally controlled substances
for lethal overdoses instead of for needed pain treatment and
palliative care. Physicians for Compassionate Care urges you
immediately to pass the Pain Relief Promotion Act.
--Respectfully submitted, N. Gregory Hamilton, M.D.
references
Barnett, E.H. (1999a). ``Is Mom Capable of Choosing to Die?''
Oregonian, October 17, 1999, G1&2.
Barnett, E.H. (1999b). ``Man with ALS Makes up his Mind to Die.''
Oregonian, March 11, 1999, D1.
Canady, C.T. Physician Assisted Suicide and Euthanasia in the
Netherlands: A Report of Chairman Charles T. Canady to the Subcommittee
on the Constitution of the House Committee on the Judiciary, 104th
Cong., 2d, 10-11 (Comm. Print 1996).
Foley, K. and Hendin, H. (1999). ``The Oregon Report: Don't Ask,
Don't Tell.'' Hastings Center Report 29:37-42.
Groenewoud, J.H. et al. (2000). ``Clinical Problems with the
Performance of Euthanasia and Physician-Assisted Suicide in the
Netherlands.'' New England Journal of Medicine 342:551-556.
Hamilton, C. (2000). ``The Oregon Report: What's Hiding Behind the
Numbers.'' Brainstorm, March, 2000, pp. 36-38.
Hendin, H. et al. (1997). ``Physician-Assisted Suicide and
Euthanasia in the Netherlands: Lessons from the Dutch.'' Journal of the
American Medical Association 277:1720-1722.
Nuland, S.B. (2000). ``Physical-Assisted Suicide and Euthanasia in
Practice, New England journal of Medicine 342:583.
Sullivan, A.D. et al. (2000). ``Legalized Physician-Assisted
Suicide in Oregon--The Second Year,'' New England Journal of Medicine
342:598-604.
Smith, W.J. (1999). ``Suicide Unlimited in Oregon.'' Weekly
Standard, November 8, 1999, pp. 11-14.
Tims, D. (2000). ``Sheridan patient Recalls Ordeal,'' Oregonian,
March 26, 2000, A1.
Tims, D. et al. (2000). ``Hospice Faces Inquiry after Four Deaths''
Oregonian, March 16, 2000, A1.
Tsao, E. (2000). ``Some Patients Who Died Refused Morphine, Records
Show.'' Oregonian, March 26, 2000, A10.
United States Supreme Court, Washington v. Glucksberg, 1997.
__________
Prepared Statement of Harvey L. Rose, M.D.
My name is Dr. Harvey L. Rose. I have been a board certified family
practitioner in the Sacramento area for the past 38 years. As a
physician on the ``front lines'' of delivering medical care, I have
both witnessed and experienced with my own patients the detrimental
impact of governmental regulatory controls on the decisions of medical
practitioners in treating their patients with acute and chronic pain. I
have devoted the past twenty years of my practice to protecting the
rights of patients who suffer from debilitating chronic pain in their
efforts to obtain adequate pain relief, educating physicians about
treating chronic pain and protecting their rights to adequately and
effectively do so; developing policy and legislation concerning the
treatment of chronic pain; and, finally, educating and reforming the
regulatory agencies themselves with regards to the use of opiod
analgesics for the treatment of chronic pain.
When other reasonable and affordable methods have failed to control
patients' chronic pain, the use of opiods has proven to be an effective
treatment, with little to no risk of addiction when used for legitimate
pain. These medications provide comfort, improved function, and
improved quality of life, with essentially no detrimental effects
except, perhaps, for constipation. Despite the safety of these
medications, for years, they have been underutilized because the
physicians' fears of getting into trouble with various regulatory
agencies, particularly narcotic enforcement at the state level and the
DEA at the federal level. The misguided efforts of these agencies often
focused on the quantity of medication begin prescribed, rather than the
individual medical requirements of each patient's condition and the
improved quality of life achieved by taking these medications. During
the dark days of the 80s and into the early 90s, frequent news reports
featured doctors being arrested, handcuffed, and charged with treating
so-called drug addicts. In reality, these were chronic pain patients,
both cancerous and non-cancerous, who had been through the medical
mill; nothing else adequately relieved their pain except for controlled
substances, particularly the opioid narcotic analgesics. Even cancer
specialists were not immune to regulatory interference: Dr. Ron Blum,
oncologist at New York University, was arrested in his office for
prescribing more narcotics than this colleagues--no small surprise, as
he was NYU's chief of oncology! And Dr. Roman DeSanctis, Dr. Henry
Kissenger's personal cardiologist, was charged by the medical board of
Massachusetts for improper use of narcotic medications for pain
management--a charge that was later overturned. With high profile
physicians like these being arrested and charged with overprescribing
narcotics, regulatory agencies created a climate of fear and
intimidation among all physicians, resulting in a widespread reluctance
to prescribe controlled substances for pain relief for the needless
suffering of thousands with pain.
In order to restrain these regulatory agencies, physicians and
patients lobbied their state legislatures. Their efforts resulted in
two Intractable Pain Treatment Acts, first in Texas in 1989, then in
California in 1990. Other states followed suit with similar intractable
pain treatment acts and pain patients' bill of rights. The state of
California has since lead the way in such efforts, with guidelines in
the use of controlled substances in the treatment of pain issued by the
state medical board and educational programs by the California Medical
Association instructing doctors on the appropriate use opioid
analgesics. I have personally been involved in the California
initiatives along with my state senator Leroy Greene in getting
organized medicine, the legislature and state enforcement agencies to
change archaic attitudes in the use of these substances to relieve pain
and suffering. I was also involved in supporting the passing of
Oregon's Intractable Pain Treatment Act, sponsored by State Senator
Kennemer. Personal experience wit this issue made the senator aware of
the need of this legislation. A few years prior, Senator Kennemer's
wife was terminally ill with cancer when she was refused more pain
medicine on the erroneous basis of its being addictive. (In my opinion,
it was the scarlet letter ``Arrest'' rather than ``Addiction'' that
kept her doctors from adequately treating her pain, in spite of the
fact that she was terminal.) My own wife of 35 years had terminal
metastatic breast cancer. After surgery for major pathological
fractures, she was given by the hospital physician only 1 to 2 narcotic
pain medicines every four hours prn--meaning she had to ask for it.
Prior to surgery, she was taking the equivalent of 8 every three hours
to control her pain. When she requested more pain medicine from the
nurses, she was told ``it wasn't time yet''. My wife died three months
later.
Nonetheless, we have continued to see gradual progress in this
area. In recent years, the Joint Commission on Hospital Accreditation
issued guidelines notifying hospitals and other outpatient facilities
that they would be monitoring them to insure that pain is adequately
treated, assessed, and managed.
* * * * * * *
We hope we have reached a point when this will no longer happen.
Yet, I feel that the provisions in the Pain Relief Protection Act, even
though they purport to give doctors more freedom in relieving pain and
suffering, will halt our hard-won progress. The fear of the DEA
becoming involved in doctors' decisions in pain management, where
intent will be questioned, is of particular concern. When doctors fear
they are going to be second-guessed by some regulatory agency and will
have to defend their decisions when it comes to treating pain and
suffering, they are going to prescribe less medicine and thereby create
more pain and suffering, which will potentially result in patients
turning to other avenues of pain relief--be they street drugs, alcohol,
or even suicide. I have the preliminary draft of a book called Painful
Exits which chronicles the terrible decisions people have had to make
for themselves and family members when severe pain goes inadequately
treated. People have committed suicide and double suicides; doctors
have been killed by patients because of inadequate pain treatment.
Physicians have also killed family members because of their receiving
inadequate relief from their pain. I have chronicled such events, but
thankfully have found fewer of them occurring in the last few years due
to a better climate of pain control and pain management in this
country.
This bill, however, will crate a tremendous chilling effect for all
physicians dealing with pain, both malignant, and non-malignant.
Physicians will tend to undertreat and underutilize these very valuable
pain relieving medications and return us to the dark ages of past
decades where people suffered needlessly because doctors were afraid to
do what they were trained to do. This bill is not necessary. At the
state level across the country, there are laws and guidelines for
physicians and the regulatory community to follow. We have the
Federation of State Medical Board Guidelines. We have the Joint
Commission on Hospital Accreditation. This bill is not needed, not only
because we have all these other avenues now, but it will negate our
progress and create a negative climate where people will again be told
that they will ``just have to learn to live with'' their pain. The
doctor's discomfort level in treating their patients' pain with these
scrutinized medications will then be far greater than their patient's
own discomfort level and pain--and we know whose discomfort level will
ultimately take precedence. I urge you to reject this bill. Let the
states and the medical community continue to do what they have begun,
maintain it, improve upon it, and keep the federal government out of
it. Thank you.