[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
OXYCONTIN: ITS USE AND ABUSE
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
OVERSIGHT AND INVESTIGATIONS
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
AUGUST 28, 2001
__________
Serial No. 107-54
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
__________
U.S. GOVERNMENT PRINTING OFFICE
75-754CC WASHINGTON : 2001
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512-1800
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COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas HENRY A. WAXMAN, California
FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia SHERROD BROWN, Ohio
STEVE LARGENT, Oklahoma BART GORDON, Tennessee
RICHARD BURR, North Carolina PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
GREG GANSKE, Iowa ANNA G. ESHOO, California
CHARLIE NORWOOD, Georgia BART STUPAK, Michigan
BARBARA CUBIN, Wyoming ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois TOM SAWYER, Ohio
HEATHER WILSON, New Mexico ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona GENE GREEN, Texas
CHARLES ``CHIP'' PICKERING, KAREN McCARTHY, Missouri
Mississippi TED STRICKLAND, Ohio
VITO FOSSELLA, New York DIANA DeGETTE, Colorado
ROY BLUNT, Missouri THOMAS M. BARRETT, Wisconsin
TOM DAVIS, Virginia BILL LUTHER, Minnesota
ED BRYANT, Tennessee LOIS CAPPS, California
ROBERT L. EHRLICH, Jr., Maryland MICHAEL F. DOYLE, Pennsylvania
STEVE BUYER, Indiana CHRISTOPHER JOHN, Louisiana
GEORGE RADANOVICH, California JANE HARMAN, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska
David V. Marventano, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Oversight and Investigations
JAMES C. GREENWOOD, Pennsylvania, Chairman
MICHAEL BILIRAKIS, Florida PETER DEUTSCH, Florida
CLIFF STEARNS, Florida BART STUPAK, Michigan
PAUL E. GILLMOR, Ohio TED STRICKLAND, Ohio
STEVE LARGENT, Oklahoma DIANA DeGETTE, Colorado
RICHARD BURR, North Carolina CHRISTOPHER JOHN, Louisiana
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
Vice Chairman JOHN D. DINGELL, Michigan,
CHARLES F. BASS, New Hampshire (Ex Officio)
W.J. ``BILLY'' TAUZIN, Louisiana
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Atwood, Theresa.............................................. 52
Coulter, Christine, Lieutenant, Philadelphia Police Narcotics
Intelligence Unit, Philadelphia, Pennsylvania.............. 19
Demarest, Andrew E., Senior Deputy Attorney General, Office
of Attorney General, Drug Strike Force Legal Service
Section, Norristown, Pennsylvania.......................... 10
Friedman, Michael, Executive Vice President, Chief Operating
Officer, Purdue Pharma, L.P., accompanied by Howard Udell,
Executive Vice President and General Counsel, and Paul D.
Goldenheim, Senior Physician............................... 35
Gibbons, Diane E., Bucks County District Attorney, Office of
the District Attorney, Doylestown, Pennsylvania............ 22
Levy, Michael H., Vice Chairman Medical Oncology, Director of
Supportive Oncology, Director, Pain Management Center, Fox
Chase Cancer Center........................................ 44
Meehan, Patrick L., Delaware County District Attorney, Office
of the District Attorney, Delaware County Courthouse,
Media, Pennsylvania........................................ 14
Woodworth, Terrance W., Deputy Director, Office of Diversion
Control, Drug Enforcement Administration................... 6
Material submitted for the record by:
Bisch, Edward J., prepared statement of...................... 76
Udell, Howard, Executive Vice President and General Counsel,
Purdue Pharma, L.P., letter dated September 5, 2001,
enclosing material for the record.......................... 78
(iii)
OXYCONTIN: ITS USE AND ABUSE
----------
TUESDAY, AUGUST 28, 2001
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Oversight and Investigations,
Bensalem, PA.
The subcommittee met, pursuant to notice, at 12:01 p.m., in
Bensalem Township Public Meeting Room, 2400 Byberry Road,
Bensalem, Pennsylvania, Hon. James C. Greenwood (chairman)
presiding.
Members present: Representatives: Greenwood and Bass.
Staff present: Ray Shepherd, majority counsel; Nolty
Theriot, legislative clerk; and Chris Knauer, minority
investigator.
Mr. Greenwood. Good afternoon and welcome. I would like to
thank Mayor DiGirolamo and thank the Bensalem Township for
hosting us this afternoon and for making the municipal
facilities available to us. It is appropriate that we be here
today because it was in Bensalem that this issue first came to
my attention.
I would also like to thank the Mayor's Executive Assistant,
Ms. Barbara Barnes, for coordinating with my staff on this
effort and Mr. Ralph Douglas, the Chairman of The Bensalem
Cable Advisory Board, who has arranged to tape this hearing for
broadcast over the township's cable system. And I believe
actually it is going out live into four different townships in
Bucks County.
The use and the abuse of OxyContin provides quite a dilemma
for us in Congress and for the American public. For some,
OxyContin is the angel of mercy; for others, it is the angel of
death. To those who suffer severe chronic pain, it brings
welcome relief. But for those who abuse this highly addictive
drug, it can bring even greater suffering.
Today, we will hear from law enforcement officials who
argue that OxyContin is quickly becoming the abuser's drug of
choice, surpassing heroin and cocaine in some jurisdictions.
We will also hear from pain specialists who argue that law
enforcement efforts and the reports of abuse in the media
should not prevent them from obtaining this miracle drug. And I
don't think anyone would disagree with that.
Let me be clear. The purpose of this hearing is not to
denounce the use of OxyContin by those who benefit from its
palliative effects. Far from it. This medicine has clearly
alleviated immeasurably more anguish than it has induced.
Rather, today's hearing is the logical extension of this
subcommittee's ongoing investigation into prescription drug
abuse throughout the United States. My staff and I have met on
numerous occasions with the DEA, the FDA, and Purdue Pharma in
order to investigate the trends of OxyContin abuse and
diversion, and well as to explore potential solutions.
Sadly, prescription drug abuse is a growing national
problem. According to the National Institute of Drug Abuse, as
recently as 1999, more than 9 million Americans, aged 12 and
older, reported that they used prescription drugs at least once
that year for nonmedical reasons. Nor is prescription drug
abuse a new problem.
For example, from 1990 to 1998, the number of individuals
initiating misuse or abuse of pain relievers increased by 181
percent, new initiates to stimulants increased by 165 percent,
tranquilizers by 132 percent, and the initiates into sedative
use have increased by 90 percent. It is especially disturbing
to note that the most dramatic increases have been found in 12
to 17-year-olds and in 18 to 25-year-olds. There is a gentleman
in the audience whose 18-year-old son perished after taking
OxyContin in combination, I should say, with another drug.
Unfortunately, Bucks County, where we now sit, is in the
media spotlight today because of the publicity surrounding the
arrest of Dr. Paolino, who stands accused of illegally
dispensing prescriptions of OxyContin to anyone with $60. Bucks
County residents purchase more OxyContin than in any other
county in the State, with the exception of the large urban
counties of Philadelphia and Allegheny. Nationwide,
Pennsylvania ranks eighth in the per capita consumption of
OxyContin.
OxyContin is a Schedule II controlled-release form of the
narcotic Oxycodone. It is available in 10 milligram, 20
milligram, 40 milligram, and 80 milligram tablets. OxyContin is
manufactured by Purdue Pharma and was introduced in January
1996.
Now, the 18th most prescribed drug in the United States,
OxyContin had more than $1.2 billion in sales from May of last
year to May of this year. OxyContin is pure Oxycodone, with no
other active ingredients, as compared to other analgesics, such
as Percocet, Tylox, and Percodan. The time release formulation
allows patients 8 to 12 hours of pain relief from a single
dose. And there is the gentleman who introduced himself to me
today who has been taking this drug for his chronic pain and is
delighted that it is available to him. The drug was developed
for people with severe, chronic pain. Make no mistake though,
in the world of pharmaceuticals, OxyContin is to prescription
drug pain relievers what jet fuel is to unleaded gasoline.
When administered correctly, OxyContin can be of enormous
benefit to cancer patients and others in severe and chronic
pain. One of the witnesses we will hear today, Pain Specialist
Dr. Michael Levy, observes that ``OxyContin is probably one of
the best drugs we have seen in the past 10 years and really
helps these patients.''
Unfortunately, the pharmacological effects of OxyContin on
those who suffer great pain are the very features that make it
attractive to abusers. First, it offers reliable strength in
dosage levels, and, second, it may be covered by the abuser's
health insurance. Abusers have discovered that the controlled
release formula of OxyContin can be easily manipulated to
produce a powerful, Morphine-like high.
Law enforcement officials have criticized the drug's
manufacturer of overly aggressive marketing practices and a
failure to swiftly respond once the abuse of OxyContin was
first reported in Maine in early in the year 2000.
In fact, on August 21, 2001, Pennsylvania Attorney General
Mike Fisher accused Purdue Pharma of continuing to use overly
aggressive marketing practices, such as using promotional pens
and conversion charts, urging physicians, many of whom were
clearly not pain specialists, to prescribe OxyContin to their
patients.
Their campaign also included efforts to persuade doctors to
switch patients who were receiving less addictive and less
powerful painkillers to OxyContin.
Recently, Purdue Pharma took some measures to prevent abuse
of its largest revenue-garnering drug by pulling its strongest
160-milligram OxyContin pills off the market in May.
They also issued tamper-proof prescription pads, which
resist copying and scanning. The pads are used by 240 doctors
here in Pennsylvania.
On July 25, 2001, the FDA announced that, in cooperation
with Purdue Pharma, it was strengthening the warning and
precautions section in the labeling of OxyContin. The changes
include a ``black box warning,'' the strongest type of warning
for an FDA-approved drug, and are intended to lessen the chance
that OxyContin will be prescribed inappropriately for pain of
lesser severity than the approved use or for other disorders or
conditions inappropriate for a Schedule II narcotic.
In addition, the company issued a ``Dear Health Care
Professional'' letter which explains the changes in labeling
and highlights the problems associated with the abuse and the
diversion of OxyContin.
These actions, though commendable, also appear long
overdue. According to DEA, the number of Oxycodone-related
deaths has increased 400 percent since 1996, the same time
period in which the annual number of prescriptions for
OxyContin has risen from approximately 300,000 to almost 6
million.
Coroners in the Philadelphia region began to see death
rates rise last year, as OxyContin became a more popular street
drug. Oxycodone, the drug's primary ingredient, was found in 17
bodies in the city in 1999. The following year, the number rose
to 41. In the first 6 months of this year, the drug was
detected in 39 bodies and was the cause of death in 11 of those
victims.
In its testimony today, Purdue Pharma will argue that the
death figures heralded by newspapers nationwide are inaccurate
and are the prime mover of the negative hype surrounding
OxyContin.
The company claims that the death reports do not take into
account the fact that in the vast majority of these cases,
Oxycodone was detected, not OxyContin, per se. In addition, the
company asserts that even in deaths where OxyContin was found,
there were additional drugs present that contributed to or even
caused the death of the individuals.
Law enforcement officials are skeptical of the company's
claims. The chief toxicologist in the Philadelphia Medical
Examiner's Office of Health care states, ``Oxycodone has been
in use for 80 years. The controlled release has not been. It is
that elevated dose that is killing them.''
The Delaware County coroner also argues that, ``When you
see 2 deaths, 3 deaths, 5 deaths, and then 17 deaths, it
doesn't take a rocket scientist to realize it is the
OxyContin.''
During this field hearing, the subcommittee will hear
testimony and engage in fact-finding concerning the rise of
OxyContin abuse from local, State, and Federal perspectives. I
look forward to hearing how DEA is working with Purdue Pharma
to reduce abuse and whether Federal and State law enforcement
officials are satisfied that Purdue Pharma has done all that it
can to reverse this dangerous and escalating cycle of abuse.
I eagerly anticipate hearing from our local and State
prosecutors in order to ascertain what tactics they have been
utilizing to combat OxyContin abuse and diversion.
And, last, I am looking forward to hearing from Dr. Levy to
gain a better understanding of the palliative properties of
OxyContin, and from Terry Atwood who will give us a firsthand
account of treatment for OxyContin abuse.
With me today, to my left, is my good friend and colleague
from New Hampshire, Charlie Bass, who has flown down to be with
us. He is a member of the Oversight and Investigations
Subcommittee. And the gentleman is recognized for 5 minutes for
an opening statement.
Mr. Bass. And I thank the chairman for recognizing me, and
I also want to thank you for holding this timely and important
hearing today. Prescription drug abuse is certainly a growing
problem in this country, and one that prescribes, if you will,
a different solution from issues involving from the abuse of
nonprescription drugs. I think as a subcommittee we need to
find out what the scope of the problem is, which we will do
today, both from the law enforcement community, as well as from
other--from our second panel.
And I think we need to address, and will address, perhaps
three, perhaps more, significant issues. Firstly, what kinds of
information do we now collect to monitor this problem, and do
we need to have different structures and different mechanisms
for developing this information so that we know what the scope
of the problem is.
Second, what responsibility should be borne by what entity
in determining how to deal with the rise or abuse of
nonprescription drugs? What--or abuse of nonprescription drugs.
What responsibility to the manufacturers or distributors or
sales agents on the other side, the doctors, the pharmacies,
and so forth, have in making sure that these very powerful, but
important, palliative drugs, are properly controlled and not
abused?
And I guess, last, I wonder what role the Federal
Government and law enforcement community in general should
play, if different from today, how their role should be
changed, enhanced, in order to make--in order to resolve this
problem, which, in my opinion, can be addressed immediately and
proactively by this subcommittee, and potentially by the
Congress. It is a very current issue. It is a serious issue.
And I commend the chairman for bringing this issue to the
attention of this subcommittee and the rest of the Congress. I
yield back.
Mr. Greenwood. I thank the gentleman from New Hampshire.
For those of you in the audience who may not be familiar with
how these processes work, I thought it might help to just put
it in perspective. Mr. Bass and I, as well as many other
Members of Congress, serve on the Energy and Commerce
Committee. It has six subcommittees, one of which is the
Oversight and Investigations Subcommittee, which I currently
chair and on which Mr. Bass serves.
One of our functions is to oversee those Federal agencies
that deal with the pharmaceutical industries, such as--and drug
issues, in general, such as the Food and Drug Administration,
as well as the activities of DEA, as it relates to these kind
of commercially available drugs. It is also our responsibility
to oversee the pharmaceutical industry as a whole.
And so that is why we are here in a fact-finding mode, to
hear from experts from around the country and from this areas,
as to recommendations, what their experiences have been, what
recommendations they may have for us, so that we can take that
information back to Washington and see if what legislative or
administrative activities that might help to resolve this
problem.
We have two panels of witnesses today. The first is
fundamentally a law enforcement panel, which is seated before
me now. And we will hear their testimony and question them. And
then we will bring a second panel consisting of representatives
of Purdue Pharma, the company that makes the product,
Representative Dr. Levy from Fox Chase Cancer Center, and we
have an expert from the Food and Drug Administration here
available to answer questions. And we will also work--have in
our second panel someone who treats individuals who abuse this
drug and other drugs.
I will call--I will identify the witnesses who are
presently seated at the witness table. From my right to your
left, we have Terrance W. Woodworth, Deputy Director of the
Office of Diversion Control, for the Drug Enforcement
Administration, the DEA, in Washington; Andrew E. Demarest--am
I pronouncing that right--is the Senior Deputy Attorney General
of the Office of Attorney General, Drug Strike Force Legal
Service Section. That is under the office of Attorney General
Mike Fisher.
Patrick Meehan, in the center, is the District Attorney
from Delaware County and he is here to talk to us about his
task force and the work he is doing in Delaware County.
Christine Coulter is a Lieutenant with the Philadelphia Police
Narcotics Intelligence unit; and, finally, to my left, Diane
Gibbons, who is the Bucks County District Attorney, is with us
today as well.
Addressing myself to the witnesses, you are aware that the
committee is holding an investigative hearing. And when doing
so, we have the practice of taking testimony under oath. Do any
of you have objectives to testifying under oath? Seeing no
objections, the Chair then advises you that under the rules of
the House and the rules of the committee, you are entitled to
be advised by counsel. Do any of you desire to be advised by
counsel during your testimony today? Seeing no responses, in
that case, if you would rise and raise your right hand, I will
swear you in.
[Witnesses sworn.]
Mr. Greenwood. So saying, you may please be seated. You are
under oath. And I would ask you to each give a 5-minute summary
of your testimony and we will start with Mr. Woodworth.
TESTIMONY OF TERRANCE W. WOODWORTH, DEPUTY DIRECTOR, OFFICE OF
DIVERSION CONTROL, DRUG ENFORCEMENT ADMINISTRATION; ANDREW E.
DEMAREST, SENIOR DEPUTY ATTORNEY GENERAL, OFFICE OF ATTORNEY
GENERAL, DRUG STRIKE FORCE LEGAL SERVICE SECTION, NORRISTOWN,
PENNSYLVANIA; PATRICK L. MEEHAN, DELAWARE COUNTY DISTRICT
ATTORNEY, OFFICE OF THE DISTRICT ATTORNEY, DELAWARE COUNTY
COURTHOUSE, MEDIA, PENNSYLVANIA; CHRISTINE COULTER, LIEUTENANT,
PHILADELPHIA POLICE NARCOTICS INTELLIGENCE UNIT, PHILADELPHIA,
PENNSYLVANIA; AND DIANE E. GIBBONS, BUCKS COUNTY DISTRICT
ATTORNEY, OFFICE OF THE DISTRICT ATTORNEY, DOYLESTOWN,
PENNSYLVANIA
Mr. Woodworth. Chairman Greenwood, Congressman Bass, other
distinguished members and guests, I would like to thank you for
the opportunity to address this subcommittee regarding
OxyContin. Mr. Chairman, on behalf of Administrator Asa
Hutchinson, I would like to thank the subcommittee for its
interest and support in assisting the Drug Enforcement
Administration with our mission of enforcing the Nation's drug
laws.
The Controlled Substances Act of 1970, which assigned legal
authority for the regulation of controlled substances to the
DEA, established five schedules into which controlled
substances are classified according to their approved medical
use and abuse potential. Schedule I controlled substances have
no approved medical use in the United States and have a high
potential for abuse, such as heroin and LSD. Schedule II
substances, including OxyContin, are approved for medical use
and have the highest abuse potential among controlled
substances approved for medical use.
OxyContin is made, as you said, by Purdue Pharma and is a
controlled release formulation of the Schedule II narcotic,
Oxycodone, used in treating chronic moderate to severe pain,
when a continuous, around-the-clock analgesic is needed for an
extended period of time. The controlled release formulation has
an important role in the management of pain.
From the first full year of sales in 1996, the number of
OxyContin prescriptions has risen 18-fold, to approximately 5.8
million prescriptions in 2000. On the other hand, another
controlled release formulation manufactured by Purdue Pharma,
containing Morphine, MS-Contin, saw an approximate 20-percent
drop in prescriptions during that same period.
During the last 2 years, DEA has noted a dramatic increase
in the illicit availability and abuse of OxyContin. As early as
1999, DEA assisted the State of Maine in the investigation of
an organized ring of individuals who used forged, stolen, and
altered prescriptions to divert thousands of dosage units of
OxyContin to abusers. While OxyContin diversion and abuse
appear to have begun more in rural areas, such as Appalachia,
it now has spread to urban areas. To date, at least 14 States
have experienced increased abuse and diversion of OxyContin,
including the State of Pennsylvania and New Hampshire.
The appeal of OxyContin for abusers, as you mentioned, is
related to the larger amount of the active ingredient,
Oxycodone, in relation to other narcotic products, and the
ability of abusers to easily compromise the controlled release
formulation. Simply crushing the tablet can negate the
controlled release effect, enabling abusers to swallow or snort
the drug for a powerful morphine-like high. The tablet can also
be crushed, mixed with water, and injected.
In response to the escalating diversion problem, DEA has
embarked upon a comprehensive action plan, focused largely on
enforcement and regulatory investigations which target key
points of diversion, including unscrupulous or unethical
medical professionals, forged and fraudulent prescriptions,
pharmacy theft, and doctor-shopping.
DEA does not intend to restrict the legitimate use of
OxyContin, nor to prevent practitioners acting in the usual
course of their medical practice from prescribing OxyContin for
patients with legitimate medical needs. The Controlled
Substance Act and DEA regulations do not attempt to define
legitimate medical purpose, nor do they set standards as to
what constitutes the usual course of professional practice. DEA
relies upon the medical community to make these determinations.
In the past, OxyContin, as you mentioned, has been marketed
and represented as having a lower abuse potential than other
opioid analgesics. And one component of DEA's action plan has
been to offer FDA information on OxyContin's potential for
abuse to assist FDA in more accurately defining the drug's
indications for medical use.
And, as you also mentioned, in July of 2001, FDA and Purdue
reached an agreement regarding labeling changes and the revised
package insert for OxyContin includes a prominent black box
warning of the drug's abuse and diversion potential,
highlighting the threat of serious injury or death resulting
from its misuse. A letter calling attention to the labeling has
been sent by Purdue to health care professionals throughout the
country.
Other issues discussed by DEA, FDA, and Purdue Pharma
include providing additional information to the medical
community on the proper use of OxyContin, as well as the
feasibility of reformulating OxyContin in order to prevent
its--reduce its abuse potential. On August 8, the company
announced the development of a reformulated version and filed
for a patent.
DEA recognizes that the best means of preventing the
diversion of OxyContin is to increase awareness of the proper
use of this product, as well as its high potential for abuse.
DEA is taking an active and measured approach to dealing with
OxyContin abuse and diversion. At the same time, DEA is
committed to ensuring that the valid interests of legitimate
pain patients, and the health care community that serves them,
are not adversely affected as a result of State, local, or
Federal law enforcement efforts, media attention, or
legislative or regulatory changes generated in response to the
problems associated with OxyContin.
Before concluding, Mr. Chairman, I would like to, on behalf
of DEA Administrator Hutchinson, and my colleagues here in the
DEA Philadelphia Field Division, thank our Federal, State, and
local counterparts, both law enforcement and regulatory,
throughout the State of Pennsylvania, as well as the U.S.
Attorney's Offices and the District Attorney's Offices around
the State, all of whom we have worked with very closely over
the years in combating drug abuse, diversion, and trafficking.
Chairman Greenwood, and, Congressman Bass, thank you very
much for the opportunity to comment on this subject. I will be
happy to answer questions at the appropriate time.
[The prepared statement of Terrance W. Woodworth follows:]
Prepared Statement of Terrance W. Woodworth, Deputy Director, Office of
Diversion Control, Drug Enforcement Administration
Chairman Greenwood, other distinguished members and guests, I would
like to thank you for the opportunity to address this Subcommittee
regarding OxyContin'. Mr. Chairman, on behalf of
Administrator Asa Hutchinson, I would like to thank the Subcommittee
for its interest and support in assisting the Drug Enforcement
Administration (DEA) with our mission of enforcing the nation's drug
laws.
The Controlled Substances Act of 1970 (CSA) assigned legal
authority for the regulation of controlled substances to the DEA. The
statute charges DEA with the prevention, detection, and investigation
of the diversion of controlled substances from legitimate channels,
while at the same time ensuring that adequate supplies are available to
meet legitimate domestic medical, scientific, and industrial needs.
The CSA established five schedules into which controlled substances
are classified according to their approved medical use and abuse
potential. The Food and Drug Administration (FDA) is responsible for
approving drugs for medical use and for regulating the marketing of
drugs by industry. Schedule I controlled substances have no approved
medical use in the United States and have a high potential for abuse.
Schedule II substances, including OxyContin', are approved
for medical use and have the highest abuse potential among controlled
substances approved for medical use. Schedules III, IV and V include
controlled substances that have a currently accepted medical use and
have diminishing potential for abuse.
OxyContin' was introduced by Purdue Pharma in 1995. It
is a controlled release formulation of the Schedule II narcotic,
oxycodone, used in treating chronic moderate to severe pain when a
continuous, around-the-clock analgesic is needed for an extended period
of time. The controlled release formulation has an important role in
the management of pain where dose administration should be limited to
twice, rather than four to six times, per day. It is currently approved
in 10, 20, 40, 80 and 160 milligram strengths.
From the first full year of sales in 1996, the number of
OxyContin' prescriptions has risen 18 fold, to approximately
5.8 million prescriptions in 2000. On the other hand, another
controlled release formulation manufactured by Purdue Pharma containing
morphine (MS-Contin) saw an approximate 20% drop in prescriptions
during that same period (from approximate sales of slightly less than 1
million prescriptions in 1996, to less than 800,000 prescriptions in
2000). Additionally, two other new products released in the mid 1990s
from the same manufacturer, OxyFast and OxylR, sold less than 100,000
and 400,000 prescriptions last year, respectively.
During the last two years, DEA has noted a dramatic increase in the
illicit availability and abuse of OxyContin'. As early as
1999, DEA assisted the State of Maine in the investigation of an
organized ring of individuals who used forged, stolen, washed and
altered prescriptions to divert thousands of dosage units of
OxyContin' to abusers. While OxyContin' diversion
and abuse appears to have begun in more rural areas of the United
States, particularly Appalachia, it has now spread into urban areas. To
date, at least fourteen States have experienced increased abuse and
diversion of OxyContin', including the State of
Pennsylvania.
The appeal of OxyContin' for abusers of controlled
substances is related to the larger amounts of active ingredient,
oxycodone, in relation to other narcotic products, and to the ability
of abusers to easily compromise the controlled release formulation.
Simply crushing the tablet can negate the controlled release effect of
the drug, enabling abusers to swallow or snort the drug for a powerful
morphine-like high. The tablet can also be crushed, mixed with water
and injected.
In response to the escalating diversion problem, DEA has embarked
upon a comprehensive action plan, focused largely on enforcement and
regulatory investigations which target key points of diversion,
including unscrupulous and/or unethical medical professionals, forged
and fraudulent prescriptions, pharmacy theft, and doctor shopping. DEA
has increased efforts to gather necessary data to better define the
scope of the problem. Such data includes information regarding
OxyContin' prescriptions, deaths, emergency room mentions,
thefts, drug treatment program admissions, and forensic laboratory
exhibits, as well as investigations, arrests and administrative
actions. DEA has also written letters to each member of the National
Association of Medical Examiners requesting medical examiner/autopsy,
toxicology, and crime scene investigator reports on all deaths related
to oxycodone in the years 2000 and 2001.
DEA does not intend to restrict legitimate use of
OxyContin', nor to prevent practitioners acting in the usual
course of their medical practice from prescribing OxyContin'
for patients with legitimate medical needs. The Controlled Substances
Act and DEA regulations do not attempt to define ``legitimate medical
purpose'', nor do they set standards as to what constitutes ``the usual
course of professional practice''--the requisite elements of lawful
prescriptions under the Controlled Substances Act and DEA regulations.
DEA relies upon the medical community to make these determinations.
In the past, OxyContin' has been marketed and
represented as having a lower abuse potential than other opioid
analgesics. One component of DEA's action plan has been to offer FDA
information on OxyContin''s potential for abuse relative to
other opioids, to assist FDA in more accurately defining the drug's
indications for medical use. In July 2001, the FDA and Purdue Pharma
reached an agreement regarding labeling changes. The revised package
insert for OxyContin' contains a prominent ``black box''
warning of the drug's abuse and diversion potential, highlighting the
threat of serious injury or death resulting from its misuse. A letter
calling attention to the labeling change is being sent by Purdue Pharma
to healthcare professionals throughout the country.
Other issues discussed by DEA, FDA and Purdue Pharma include
providing additional information to the medical community on the proper
use of OxyContin', as well as the feasibility of
reformulating OxyContin' in order to reduce its abuse
potential. On August 8, 2001, the company announced the development of
a reformulated version of OxyContin'. Purdue Pharma
estimates that the new formulation may be marketable in three years.
DEA has initiated meetings with the National Alliance for Model
State Drug Laws, which has been the catalyst for the establishment of
state prescription monitoring programs. Such programs provide a better
mechanism to gather and evaluate prescription data, which is essential
in responding to newly developing trends in prescription drug abuse.
Existing data sources (IMS, Inc.) indicate that the five states with
the lowest number of per capita OxyContin' prescriptions all
have long standing prescription monitoring programs in place. These
five states, beginning with the fewest per capita prescriptions for
OxyContin' are California, Illinois, New York, Texas, and
New Mexico. The majority of states reporting significant abuse and
diversion issues are those without such programs. DEA has embarked on a
number of programs to collect and monitor prescription data for
controlled substances.
DEA recognizes that the best means of preventing the diversion of
OxyContin' is to increase awareness of the proper use and
potential abuse of the product. DEA is taking an active and measured
approach to dealing with OxyContin' abuse and diversion. At
the same time, DEA is committed to ensuring that the valid interests of
legitimate pain patients and the health care community that serves them
are not adversely affected as a result of state, local or federal
enforcement efforts, media attention or legislative or regulatory
changes generated in response to the problems associated with
OxyContin'.
Before concluding, I would like to thank my colleagues at FDA for
their cooperation in addressing this very important issue.
Finally, Mr. Chairman, I thank you and the members of this
Subcommittee for the opportunity to comment on this topic. I look
forward to addressing any questions that you may have at the
appropriate time.
Mr. Greenwood. Thank you very much for your testimony. I
think that the--you see these silver microphones on triangular
stands. Those are the ones that are--need to be utilized for
the cable television. We would now recognize--call upon Andrew
Demarest, the Senior Deputy Attorney General, for the Office of
Attorney General, Pennsylvania, for your testimony, sir.
TESTIMONY OF ANDREW E. DEMAREST
Mr. Demarest. Thank you. Good afternoon, Chairman
Greenwood, and, Congressman Bass, and, members. I would like to
thank the committee for giving Attorney General Fisher's office
an opportunity to testify today on a problem that is exploding
in Pennsylvania right now. The abuse of the brand name
painkiller OxyContin is rising on a tremendous scale, placing
people who are unaware of its lethal potential in danger, and
placing a burden on law enforcement agencies across the State
as they try to contain the distribution. I commend the
committee on being so quick to shed light on this new danger.
Hopefully, by giving this matter the spotlight on this matter,
we can stem the tide of the deaths that abuse of this drug is
causing.
A little background from what the State has seen on
OxyContin--when OxyContin is prescribed, it provides effective
pain management for cancer patients and others suffering with
chronic pain. When properly taken, OxyContin tablet is time-
released and provides the patient with up to 12 hours of pain
relief. The danger arises when the time-release mechanism is
bypassed. Abusers will either chew or crush a tablet. It can be
snorted or mixed with water, or injected, like heroin. This
puts the drug into the system all at once to deliver an intense
high, much like high-grade heroin.
For example, 5 milligrams of OxyContin has the same active
ingredient, Oxycodone, as one Percocet. So chewing or snorting
a single 80-milligram OxyContin tablet is like taking several
Percocet tablets all at once. Few abusers fully realize the
enormous potency of the drug that they are taking, and,
frankly, that is contributing to the deaths.
When taken by a person whose body is, in any way,
intolerant to the drug, or when taken in conjunction with other
depressants, like alcohol, the result will be the death of the
user. The drug slows the respiratory system. The abuser will
lose consciousness and breathing and will eventually die. To
date, Pennsylvania has not accumulated the total number of
deaths linked directly to OxyContin abuse. Remember, this is
still a relatively new phenomenon, however, the medical
examiner of Delaware County has reported at least 17 deaths
attributable to this drug.
On the street, the drug sells for various prices, depending
on the geographic location. OxyContin sells for 50 cents to $1
per milligram. So a 40-milligram tablet, which would sell
legitimately for $4, will bring up to10 times that amount of
money on the street. So not only is the drug in demand by
addicted abusers, but there is a strong profit motive in its
illegal distribution, as we have seen.
The distribution scheme that is illegal in the State is
seen in the following circumstances: A doctor who fraudulently
prescribes OxyContin to abusers for money. A pharmacist who
illegally fills an abuser's prescription, or who forges
prescriptions for abusers. Abusers who steal prescription pads,
and then write their own forged prescriptions. And a phenomenon
we call doctor-shopping. That is individuals that go from
doctor to doctor faking illness to obtain several prescriptions
of the same drug. Dealers or abusers also who then burglarize
pharmacies. And we have had several armed robberies across the
States of individuals breaking into pharmacies and seizing
OxyContin at gun point.
In the past 2 years, the Office of Attorney General has
conducted nearly 100 OxyContin abuse investigations throughout
the Commonwealth. Recently, I have just approved 10 arrest
warrants in the last 2 weeks, and 4 of those have been for
OxyContin. The other remaining were for other prescription
drugs.
Mostly notably in June, the agents of the Attorney
General's Office arrested a Philadelphia man who illegally
possessed over 3,000 prescription drug tablets, including a
kilogram of OxyContin. This was nearly 900 tablets, with a
street value of $60 per tablet. Raymond Johnson has been
charged and is under prosecution by the Philadelphia District
Attorney's Office.
Additionally, there have been the other investigations that
Congressman Greenwood has mentioned, including Dr. Paolino, and
another one that was worked cooperatively with District
Attorney Gibbons' office, Lewis Winokur, who is a Bucks County
pharmacist.
In addition to these problems, our office is addressing it
by working cooperatively with DEA's Diversion Unit, who has
been spectacular. As far as cooperation, they have established
a task force in Philadelphia. We are working directly with the
Philadelphia Police Department, the State Attorney General's
Office, and DEA agents.
Additionally, we are participating in regional educational
opportunities for both law enforcement individuals and health
care professionals. The one, which was recently held on August
21 in King of Prussia. We can alert many of the health care
providers to the elaborate schemes that are used for diversion
of drugs.
In addition, we have taken legislative opportunities with
the State legislature. We cannot make the possession of this
drug an offense, as was done with GHB, which became a Schedule
I controlled substance. So we have to modulate how we attack
the drug within the confines of legitimate scheduling of the
drug.
One of the main undertakings that our office has done is to
computerize the gathering of Schedule II prescription
information. We obtain from every pharmacy in the Commonwealth,
on manual form right now, a prescription printout that would
show who is obtaining OxyContin across the State. We have
applied for and received a grant from the Pennsylvania
Commission on Crime and Delinquency and we are now
computerizing that data and have been in the process of doing
that for a couple of years, due to the changing pattern of
technology within the pharmacy environment. We now have at
least three large chain pharmacies that are doing that with us.
So we will be able to target the doctor-shoppers, which are a
problem. Also, there have been legislative changes.
And as far as working with the pharmacies and the doctors,
we do take note that it is Pennsylvania law, according to the
Superior Court, that every member of a health care team has a
duty, to a limited extent, to be his brother's keeper, and we
intend to make sure that they understand that obligation.
Thank you, Congressman Greenwood.
[The prepared statement of Andrew E. Demarest follows:]
Prepared Statement of Andrew E. Demarest, Senior Deputy Attorney
General, Pennsylvania Office of Attorney General
Good afternoon Chairman Greenwood, and members of the House
Committee on Energy and Commerce. I'd like to thank the Committee for
giving me the opportunity to testify today on a problem that is
exploding in Pennsylvania right now. The abuse of the brand name
painkiller OxyContin is rising on a tremendous scale--placing people
who are unaware of its lethal potential in danger, and placing a burden
on law enforcement agencies across the state as they try to contain its
distribution. I commend the Committee for being so quick to shed light
on this new danger. Hopefully, by giving the matter the spotlight this
early, we can perhaps stem the tide of deaths that abuse of this drug
is causing.
Since this is such a new problem, allow me to give the Committee a
little background on what OxyContin is and why its abuse has such
devastating effects. OxyContin is a high potency pain killer derived
from opium. When used as prescribed it provides effective pain
management for cancer patients and others suffering from chronic pain.
When properly taken, an OxyContin tablet is time-released and provides
the patient with up to 12 hours of pain relief. The danger arises when
that time release mechanism is bypassed. Abusers will either chew or
crush a tablet, so that it can be snorted or mixed with water and
injected--like heroin. This puts the drug into the system all at once
and delivers an intense high, much like high-grade heroin. This is why
OxyContin is sometimes referred to on the street as ``poor man's
heroin'' or ``hillbilly heroin.''
For example, five milligrams of OxyContin has the same active
ingredients as one Percocet--so chewing or snorting a single 80
milligram OxyContin tablet is like taking 16 Percocets all at once. Few
abusers fully realize the enormous potency of the drug they are taking,
and frankly, this is why many of them are dying. When taken by a person
whose body is in any way intolerant to the drug, or when taken with
other depressants--like alcohol--the result will likely be the death of
the user. The drug slows the respiratory system. The abuser will lose
consciousness and breathing will decrease until it eventually stops. To
date, Pennsylvania has not accumulated the total number of deaths
linked directly to OxyContin abuse--remember that this is still a
relatively new phenomenon--but recently the medical examiner in
Delaware County reported that 17 deaths last year [2000] were
attributable to the abuse of this drug. That's a significant number,
and I believe we can expect to see similar figures throughout the
southeast and across the Commonwealth.
On the street, prices for the drug vary depending on geographic
location. But generally, OxyContin sells between 50 cents and $1 per
milligram. So a 40 milligram tablet which sells legitimately for $4
will bring 10 times that amount on the street. So not only is the drug
in demand by addicted abusers, there is a strong profit motive in its
illegal distribution. Because OxyContin is a Schedule II prescription
drug with a very legitimate value for treating chronic pain--the
illegal activity of getting it into the hands of abusers is centered
around pharmaceutical diversion. The illegal distribution of the drug
typically involves the following criminal activity:
A doctor who fraudulently prescribes OxyContin to abusers for
money.
A pharmacist who illegally fills an abuser's prescription, or
who forges prescriptions for abusers.
Abusers who steal prescription pads, and then write their own
forged prescriptions.
Dealers, or abusers themselves, who burglarize pharmacies.
In the past two years, the Pennsylvania Office of Attorney General
has conducted nearly 100 OxyContin abuse investigations throughout the
Commonwealth. Many of these investigations have resulted in arrests,
while others are still pending. Allow me to tell you about some of the
recent efforts the Bureau of Narcotics Investigation has been making in
this region of the State:
In June, agents arrested a Philadelphia man who illegally
possessed over 3,000 prescription drugs, including a kilogram
of OxyContin. This was nearly 900 tablets, with a street value
of $60 per tablet. Raymond Johnson, of Elsinore St.,
Philadelphia, was charged with illegal possession of a
controlled substance and possession with intent to deliver. If
convicted, he faces up to 15 years in prison.
In April, we concluded an investigation into a Bucks County
pharmacist who was allegedly producing fraudulent prescriptions
in order to illegally distribute OxyContin. Lewis Winokur, who
practiced in a Bristol Township pharmacy, is charged with
filling fake prescriptions in the names of customers he
obtained from his pharmacy, and sold them to OxyContin abusers.
The names of the customer's physicians were then allegedly
forged by the drug addicts. Winokur was charged with 11 counts
of illegal delivery of a controlled substance by a
practitioner, and tampering with public records. He is facing a
maximum penalty of more than 100 years in prison and more than
a $1 million in fines.
In March, our BNI agents and Bucks County law enforcement
officers arrested Dr. Richard Paolino, who practiced in
Bensalem. Our investigation alleges that Paolino's practice
amounted to a revolving door for OxyContin junkies. The
confidential informant, who worked with our agents, went to
Paolino's office every month to get OxyContin and Xanax without
ever being examined. We allege that it was standing room only
in Dr. Paolino's waiting room, and most of the patients were
gaunt, with dilated eyes. Some ``patients'' showed obvious
signs of withdrawal. Dr. Paolino allegedly only accepted cash
for office visits--$66 for the first visit, $59 thereafter.
Paolino was allegedly handing out so many prescriptions that
our office was originally alerted to the problem by a
Philadelphia pharmacist who was being confronted with so many
Paolino Oxy prescriptions that he eventually stopped filling
them.
In addition to dedicating agents and resources to investigating
specific instances of abuse, the Bureau of Narcotics Investigation will
be operating regional educational programs for both law enforcement
agencies and health care professionals. Since the abuse of OxyContin is
such a new phenomenon, most local police forces lack the experience to
properly target the problem in their communities. Health care
professionals, such as pharmacists, also need to be educated to the
potential this painkiller has to be diverted into a lethal street drug.
The Office of Attorney General's experience in dealing with OxyContin
abuse needs to be disseminated throughout the Commonwealth. For
although the problem is particularly bad in the southeast, it will
quickly spread.
The first conference--which was held on August 21st in King of
Prussia--is designed to give local law enforcement agencies training in
dealing with this new epidemic of drug abuse. We can share our office's
experience in attacking the problem. We can identify the abuser
population that is likely to possess the drug. We can alert them to the
often elaborate schemes that are used to divert this scheduled drug out
of the hospitals and pharmacies and onto the street where it kills. For
example, the Bucks County case I mentioned earlier involved a medical
professional--a licensed pharmacist--manipulating the records of his
workplace in order to duplicate legitimate prescriptions and sell them
to drug addicts. This is not a run-of-the-mill street drug distribution
ring with which local investigators are familiar. Medical
professionals, as well, need to be aware of ways this dangerous drug
can fall into the wrong hands.
These are the actions that our office has taken and will continue
to take in response to this new drug epidemic: targeted enforcement of
the current drug laws and education of local law enforcement agencies.
But you, as members of Congress, are wondering what you can do to
assist law enforcement in fighting the problem. OxyContin presents a
somewhat unique problem because it is a legitimate drug that--when
properly prescribed and taken--serves as a valuable tool in treating
chronic pain. We cannot simply make its possession an offense, as the
Pennsylvania General Assembly did in 1999 when it made GHB a Schedule I
controlled substance. Any attempt to deal with this problem statutorily
must be aimed at the diversion of the drug from its intended
pharmaceutical use to its abuse as an illicit street drug. Our office
has offered the following legislative recommendations to the
Pennsylvania General Assembly:
The theft of a prescription blank or a prescription pad should
be a distinct offense punishable as a third degree felony.
Right now, the theft of a prescription blank is graded only on
the value of the paper--a low misdemeanor. But the potential
street value of the prescription drugs that can be illegally
obtained with just one pad of blanks can be thousands--perhaps
hundreds of thousands--of dollars. That is the value on which
the offense should be graded. Each of those little slips of
paper must be viewed as a significant source of revenue for the
OxyContin dealer, and the possible death for the addict who
doesn't know the danger of the drug he or she is taking.
The outright theft of a prescription drug should be a felony
offense under the Controlled Substances Act. Currently, the
Controlled Substances Act only prohibits the obtaining of
prescription drugs through fraud or forgery. The simple theft
of these drugs is a Title 18 offense, graded on their actual,
legitimate commercial value--which is relatively low. The
penalty for stealing these drugs should reflect their potential
both in street value and in harm to the user.
The practice of ``doctor shopping'' should be a distinct
offense under the Controlled Substances Act. Very often,
illicit prescriptions for drugs like OxyContin are obtained by
one individual who visits doctor after doctor complaining of
phantom symptoms. The prescriptions are then filled and the
dealer is in business. This practice should be recognized and
punished for the crime that it is.
Again, I'd like to thank Chairman Greenwood for inviting me here
today to testify on this new wave of drug abuse that threatens our
communities. I believe that directing both the public's and Congress's
attention to the abuse of OxyContin at this stage in the trend will
help to minimize the damage it causes.
I would be happy to answer any questions the members of the
Committee may have.
Mr. Greenwood. I thank you very much for your testimony. We
now turn to Patrick Meehan, the Delaware County District
Attorney.
TESTIMONY OF PATRICK L. MEEHAN
Mr. Meehan. Good morning, Mr. Chairman, or good afternoon,
Mr. Chairman, and good afternoon, Congressman Bass. And I want
to thank you for giving me this opportunity to speak on behalf
of law enforcement, but also just to speak as one who is a
prosecutor, but a community leader. And I think that we have
looked at this issue in Delaware County as one which is not
just exclusively a law enforcement issue, but also one that is
really a public health issue. And we have taken a collaborative
approach to that problem, and I know that is something, in
communications with your staff, that you wanted me to
articulate more on in the 5 minutes that you have scheduled. So
rather than be redundant with some of the information, I would
like to focus a little bit on that.
I have some opening observations. I think you couldn't be
more on point with your identification of the paradox here with
this drug. It is--and I have gotten phone calls from people who
are using this with legitimate prescriptions who are in severe
pain and talk about what a tremendous difference it has made to
their lives. But we are also dealing with people who now are
abusing it or addicted to it. We have crimes that grow out of
that addiction.
And, as I will demonstrate, we believe and we have seen
verifiable proof of increased deaths in Delaware County as a
result of it. So that paradox exists that, you know, those who
legitimately use OxyContin fear that the recent controversy
will mean tighter restrictions on the drugs, but abusers will
go to great lengths, legal or illegal, to gain that powerful
drug.
You know, we see it come in, in a variety of different
ways. And my greatest concern, as a prosecutor, is its movement
into what we call the recreational use or the rave scene, so to
speak. And there is reasons a drug like this can begin to
ingratiate itself into that scene. I think that like Ketamine,
GHB, and Ecstasy, what we have are some characteristics. One,
it is a manufactured drug. And there is this perception out
there that because it is not produced illicitly, like heroin or
cocaine, that somehow there is some level of safety. And so
those who are abusers are looking for the drug itself.
But we have a significant number of kids that are
experimenting. And they are using not just alcohol, but a whole
bevy of drugs. And this has found its way into what we call the
club-drug scene. And I think it is particularly dangerous
because of our concerns of what it can do. Because it is not a
drug that is taken intravenously, the kids don't have the same
concern about AIDS or hepatitis contamination. I think that it
has a salability--you know, the kids, where when it is marketed
out there in the street, we call it the Madison Avenue side of
the drugs--you know, there are OC's or Oxy's out there and the
Ecstasy. These kind of manufactured drugs sound good to the
kids and, as a result, they are not as threatening.
And, of course, one of the things that needs to be
understood, and I think it is accurate, it is not a drug that
is operating solely and exclusively. While there may be some
who are using it for the ability to be responsive to their
addiction, what we are seeing is that the drug is often used in
combinations with other drugs, even addicts may be using it in
combination with alcohol or other kinds of prescription drugs.
My biggest concern, as a prosecutor, and someone in public
health, is the potential that it is truly a gateway drug to
more serious abuse, and specifically heroin. And when we begin
to deal with somebody who is addicted to heroin, we have
significant issues, both from a public health perspective and a
law enforcement perspective because of the associated crime
that often is associated with the necessity, to find the money
to pay for it.
And what is unique about OxyContin is the fact that it sort
of builds in something that heroin and cocaine don't. The
market for heroin and cocaine, the illicit market, you know,
has increasing steps, from distributors on down, and the profit
margins are incremental.
With Oxycodone, somebody--or, OxyContin, somebody who can
get a $4 tablet legitimately prescribed, or get it through
diversion or doctor-shopping, or all the things we have talked
about, you know, gets a $40 markup out on the street. So in
addition to feeding the addiction, there is a natural
attraction to go after this particular drug because it helps to
perpetuate the opportunity to feed the addiction.
You are going to hear a lot from law enforcement about the
issues of diversion, pharmacy robberies, other kinds of things,
new laws that ought to be established. And I didn't want to
necessarily go there, except to articulate one particular
concern. And I was away in Boston just this last week, and one
of the things that happened there is it is not just pharmacies
up there. They had a nursing home that was raided at gun point
late in the evening. And we have to be aware that this drug is
not just available only in pharmacies. And I think we have got
a particularly vulnerable population. And I have a concern that
this is the kind of crime that could be repeated in other areas
of the country.
When we approached this again, we looked at it, as I said,
I have got a responsibility to the criminal justice side, and
we are very proactive, along with all my colleagues, looking at
increased enforcement whenever we see a problem.
But when we began to see a problem, we have a history over
the last 4 years in Delaware County of identifying community-
wide problems. We have worked on the issue of school safety and
crisis response. We went to the issue of identification of at-
risk kids. The third year, we looked at the issue of youth
suicide in schools. And the fourth year, in consultation with
the group that I regularly meet with once a month, which
consists of our county medical examiner, my chief probation
officer, the head of our Department of Public Health, the head
of my county school system, and myself, we try to identify
issues we think that are of community concern and
collaboratively look at a way to approach it.
And it was in that context that our medical examiner, Rick
Hellman, who is a tremendously distinguished person in his own
right and looks at his responsibility to be more than just, you
know, dealing with death after the fact, but in a community
health perspective--and you will see to my right what we have
experienced in Delaware County. And I will just very briefly
explain one small bit of it.
What we have done over the course of time is to track a 10-
year history of Oxycodone abuse in Delaware County. And the
medical examiner went through historically of all the records
from the period of 1991 through the year 2001. Now, we weren't
talking OxyContin in many of those earlier years because, of
course, it was not a manufactured drug at that point in time.
But we did have Percodan and Percocet, you know, the 5-
milligram tablet. And what you can see is, in our county of
about 500,000 people, you saw an average of about 3, 4, 5
deaths a year in which Oxycodone was one of the agents that
attributed--that was attributed to overdose deaths.
Mr. Greenwood. If I can interrupt you. If you take your
seat and describe the chart, I think they will be able to hear
you on the television, and otherwise, they won't be able to. I
am afraid that is a technical problem we have.
Mr. Meehan. I am sorry, Mr. Chairman. And I can do that
from here just as easily. But as you look over the charts,
again, what I wanted to identify for you is, as the medical
examiner went through those statistics over a 10-year period,
what you begin to see, almost commensurate with the
introduction of OxyContin, and regularly into commerce, is the
critical year of 2000, when we had 18 deaths. So the dramatic
spike of about 4 a year to 18 deaths. And as of the first 5\1/
2\ months of the year 2001, we have had five associated with it
at this point in time.
We took an approach to this then that was community-wide
and it led to each of us trying to define a way that we could
influence the problem. We have worked with each of our health
care providers so that we are trying to have our county medical
society and our pharmacy association do two things. One, they
are communicating down the lines with specific information to
both pharmacists and to doctors in our region, giving them
vital information about this problem. They are also trying to
track information on how it is being used in Delaware County.
We are working with our treatment providers to identify
whether we are getting an increase in this kind of drug abuse.
And I can tell you anecdotally, we have seen about a 20-percent
increase in self-reported abuse by people who are seeking
treatment. And we are working with our school system and others
in a comprehensive effort to make this a critical educational
objective this year so that throughout our school system,
throughout our law enforcement community, what we want to try
to do is educate people about the potential for abuse.
And, again, the critical segment that we are trying to get
to is that user population that might be fooled into thinking
that there is not danger associated with recreational use of
the drug. The abuser population is more complicated. And we are
also talking with our folks about treatment modalities, to have
somebody step down to--you know, once they have had that issue.
So I wanted to show the statistics which verify the concern
and then articulate at least what is a community-wide approach
that we have tried to take to the problem. Thank you, Mr.
Chairman.
[The prepared statement of Patrick L. Meehan follows:]
Prepared Statement of Patrick L. Meehan, Delaware County District
Attorney
Chairman Greenwood, members of the committee, ladies and gentlemen.
Thank you for the opportunity to be here with you today to talk about a
serious issue that effects both our public health and the fight against
crime. That problem is the growing abuse of a legal prescription drug,
Oxycontin.
The drug Oxycontin has presented public officials at all levels of
government with a unique problem. One the one hand, this drug, when
used properly, as prescribed by a caring physician, can be a life-
enhancing solution to the severe pain suffered by people afflicted with
debilitating injuries and diseases. On the other hand, when this
powerful drug is abused, by being crushed or chewed and ingested, it
can kill. This powerful drug presents such a clear paradox that a Web
site devoted to the controversy surrounding it begs the simple
question: Oxycontin--Savior or Killer?
As a local prosecutor, my first and foremost concern about this
drug is its potential to become an attractive drug of choice for
recreational users and in particular for the young people who populate
the ``Rave Culture.'' Prosecutors have already seen the drugs Ecstasy,
GHB, and Ketamine become popular with recreational users because the
abusers have deceiving themselves into thinking that they are not as
harmful as illegal drugs such as cocaine and heroin. This deception
occurs for a number of reasons: (1) Because these drugs are
manufactured, not produced illicitly, abusers have a false sense of
security in the drug's safety. (2) Because these drugs are not taken
intravenously, abusers feels safe from AIDS or hepatitis contamination.
(3) Prescription or chemical drugs come with what I call a ``Madison
Avenue-type'' appeal; their scientific-sounding names raise the sense
of excitement for the user. And lastly (4) these drugs are readily
available. They are, after all, sold legally at the neighborhood drug
store to anyone with a prescription.
Oxycontin abuse by recreational users is particularly disturbing
because the drug can become a ``Gateway'' drug to other narcotics, such
as cocaine and heroin. Whenever a recreational user begins narcotic
drug use, the potential for addiction is great. The recreational user
who began narcotics with Ecstasy or Oxycontin may need to continue to
get his high, but often finds the legal supply inadequate or
unavailable, sometimes because of price. Oxycontin is an expensive
drug, selling on the street for $0.50 to $1.00 per milligram.
Prescription use calls for 2 tablets a day--each tablet, through a
timed release, providing pain relief over a 12-hour period. Abusers
will crush or chew the tablet to get the instant high, making the drug
potentially lethal, but also requiring more tablets for abusers to stay
high. Because Oxycontin may cost $40-$80 per tablet on the street,
addicts may find it cheaper to buy cocaine or especially heroin, which
unfortunately are easily available in Southeastern Pennsylvania.
The abuse of prescription drugs has created issues for prosecutors
that may require changes in the law. First, the most important function
of law enforcement in the fight against prescription drug abuse is to
combat the sale or ``diversion'' of the drug by a new breed of drug
dealers. These drug dealers are not of the usual ``street--corner
variety''. Increasingly, we are seeing doctors and pharmacists engage
in these ``diversion'' schemes by selling sale prescription drugs to
abusers. The Bucks County case of Dr. Richard Paolino is a perfect
example of the professional fraud that we know exists when you have a
product like Oxycontin, which sells on the street for $40 to $80 per
tablet and is capable of producing such an addictive high that it is
commonly called ``the Poor Man's Heroin.''
As you will hear today from other speakers, Pennsylvania's Attorney
General Michael Fischer is working with the General Assembly on
legislative proposals to give law enforcement new tools to combat the
diversion of prescription drugs. First, he is seeking to increase the
criminal penalties for the theft of either prescription ``scripts'' or
for the drugs themselves. Second, he is seeking the creation of a new
crime to stop the practice of ``doctor shopping'' to acquire
prescriptions. Attorney General Fischer has also been working in
cooperation with the federal Drug Enforcement Agency (DEA) to create an
electronic pharmacist reporting system here in Pennsylvania. These
systems, in place in states like Kentucky, have allowed law enforcement
to more closely monitor and catch pharmacists and doctors who
participate in drug diversion schemes. I support their efforts and I
hope we will see legislative action in Harrisburg on these proposals
this fall.
But we know that solutions to the problem of the abuse of
prescription drugs like Oxycontin are not just matter of criminal law.
This is a community problem, requiring collaborative efforts between
government institutions, and in combination with civic and professional
organizations. That is the approach we have taken in my county,
Delaware County, which I am proud to share with you today.
In Delaware County, the problem of Oxycontin abuse was first
brought to our attention by the work of our Medical Examiner Dr.
Frederick Hellman. As you can see from the accompanying charts (Chart
1), Dr. Hellman has documented 18 deaths in our county in the year 2000
where at the time of death the decedent had Oxycodone in their system,
usually in combinations with other drugs that the decedent had been
abusing. These 18 deaths represented an explosive increase in Oxycodone
abuse in our county. We had never before had more than 5 such deaths in
one year since the introduction of the drug Oxycontin into the
marketplace in 1996. Yet in just the month of April of 2000 alone,
(Chart 2) there were 6 Oxycodone related deaths in the county. We have
attributed this increase to the growing popularity of Oxycontin as a
drug of choice for abusers on the east coast. These numbers are proof
that Oxycontin abuse, which first began in southern and midwestern
states, has now moved east to the metropolitan areas of the Mid-
Atlantic States.
When Dr. Hellman brought his findings to the attention of myself
and members of the Delaware County Council, we decided to address the
problem by using a collaborative interdepartmental approach. We focused
on three goals: (1) education, (2) prevention, and (3) prosecution. For
us in Delaware County, this was not a departure from standard practice
but another application of our working county governmental paradigm to
a new challenge.
Increasingly, we in county government find ourselves challenged by
community problems that have no easy answer. Under Pennsylvania law, it
is the primary responsibility of county government to provide for
systems of law enforcement and behavioral human services for our
communities. We have found, in Delaware County, that the problems we
deal with in law enforcement generally have a human service aspect that
must be addressed. We have come then, over the last several years, to
find that the most efficient and productive way to do our jobs for our
constituents is to work together.
We first created this collaborative paradigm in our efforts to
combat school violence. In the spring of 1997 I brought together school
administrator, teachers, local police, and behavioral service providers
to work together to begin to identify issues of school safety in our
county. In November of 1998, this working group hosted our first Safe
Schools Summit. The result of that summit and the one that followed was
the development of a ``Delaware County model'' of training for first
responders to incidents of critical school violence. That model,
developed through real school violence simulation exercises, has been
distributed across the country in a videotape format by the National
Tactical Officers Association (NTOA), who have endorsed this training
model. This year we devoted our third Safe Schools Summit to the often
overlooked issue of teen suicide and the need to identify and combat
what is the third leading cause of death for American teenagers.
We are now applying what we have learned by working together on
safe schools, to the problem of Oxycontin abuse. In July, I held a
press briefing along with Dr. Hellman to begin the educational campaign
about Oxycontin. Our County Council later dedicated a public meeting to
the issue and has since required all county agencies to work together
to identify abusers who come into our offices for behavioral treatment.
County Council also has produced a public informational flier on the
dangers of Oxycontin. To further our goal of prevention through public
education, we are getting that flier to our county agencies and to such
groups as the Delaware County Medical Society.
The next, and perhaps most vital step in our county campaign
against Oxycontin abuse, is the educational effort we will undertake
this fall in our schools to raise the awareness of our young people to
of the danger of this drug's abuse. As we all know, many students
unfortunately begin experimenting with recreational drugs at an age
when they possess a misguided sense of invincibility about such
dangerous things. It is for their protection that we will be devoting
our next Safe Schools Summit to the overlooked issue of prescription
drug abuse.
My hope is that our Delaware County collaborative approach to
combating oxycontin abuse will be a model for other counties to follow,
as they face this issue important public health issue, and I thank the
members of this committee for their time and attention today.
Mr. Greenwood. Thank you, Mr. Meehan. Thank you for your
testimony and for being with us. Next, we will hear from
Christine Coulter, Lieutenant, Philadelphia Police Narcotics
Intelligence Unit. Thank you for being with us, and the floor
is yours.
TESTIMONY OF CHRISTINE COULTER
Ms. Coulter. Good afternoon, Chairman Greenwood, Mr. Bass,
members of the committee. I am honored to be here to speak to
you on behalf of the Philadelphia Police Department regarding
the abuse of OxyContin in the communities we serve. I must
admit that prior to the fall of 2000, I knew very little about
OxyContin. In the months to follow, there was a concerted
effort made by my colleagues and myself to learn all that we
could so we could better combat this emerging problem.
I will leave the medical testimony for the medical
professionals regarding the legitimate use of OxyContin. I am
here today to testify solely about the drug's abuse in
Philadelphia and our surrounding counties and the law
enforcement efforts to combat this problem.
The effects of this abuse has been devastating to many
families and communities in our area. The increase in deaths in
Philadelphia where there was a presence of Oxycodone in the
body is quite alarming. The Office of the Medical Examiner
reported 17 cases in 1999, 41 cases in 2000, and, in June of
2001, there are already 39 reported cases. If this trend
continues, it will likely result in the death toll from abuse
doubling in 2 consecutive years.
Although Oxycodone is present in other substances of abuse,
and there were indications that other pills and alcohol were
also contributing factors, we would be remiss in not reacting
to the increase with a sense of urgency.
The abuse of OxyContin in Philadelphia is a rather recent
development. Beginning last year, we began to experience some
problems that our fellow law enforcement officers in
surrounding areas have dealt with for quite some time. The
migration to the city and surrounding suburbs happened quickly,
necessitating the development of a strategy that would stem the
tide of OxyContin abuse. We had to quickly examine the areas of
diversion so we could implement a suitable plan to combat
abuse.
An analysis was done and it was determined that there were
three major diversions present in our city. The first is the
outright theft of the product, or prescription pads, from
legitimate patients, pharmacies, or practitioners. These thefts
were committed by relatives, employees, and, in some instances,
robbers and burglars.
Second, individuals without legitimate medical necessity
can obtain OxyContin by reporting made-up symptoms of pain to
unwary, uneducated, or disinterested practitioners. This method
is a low-risk alternative for pill diverters, since
prescriptions is issued in the person's name, often at a low-
cost as well, since medical insurances normally cover most of
the cost of the pill. This also engenders the practice of
doctor-shopping, going from one doctor to another, giving the
same complaint, and getting the medications repeatedly
described. It is not uncommon to do so using multiple names and
prescription plans and having the prescriptions filled at
multiple pharmacies to camouflage this fraudulent practice.
The third and often largest diversion method are pill-mill
operations, where corrupt doctors or pharmacists conspire with
pill traffickers to write or fill fraudulent prescriptions for
ghost patients and then selling the drug on the street at up to
100 percent profit. There is also the presence of insurance
fraud in this diversion method, as health plans, both private
and governmental, are billed by providers for falsely reported
office treatments and prescriptions dispensed.
High volume operations, such as pill-mills, lend themselves
to tracking by audits of physician records and pharmacy orders
of commonly abused controlled substances such as OxyContin Drug
diversion agents from both the Drug Enforcement Administration
and the Pennsylvania Attorney General's Office, Bureau of
Narcotics Investigations and Drug Control, have the ability to
administratively inspect and analyze such records. There is
currently a tremendous amount of cooperation with these
agencies, which enables us to build strong cases, while
eliminating duplication of effort and wasted resources.
Local law enforcement, however, does not presently have the
authority to administratively subpoena prescription records.
Enabling local police officers to analyze these records will
encourage a more proactive investigation of drug diversion
conspirators on the local level. Coupled with aggressive
prosecution and enhanced sentencing of licensed health care
professionals engaged in prescription drug diversion schemes,
it may also discourage such corrupt practices. There is also a
need for legislation to make all pharmaceutical thefts a
felony, factoring in the street value of the drug into the
equation.
There was also a great need to train our officers, as well
as educate health care providers and the public alike. Training
bulletins were prepared for our officers and seminars were
attended to gain insight to the problems associated with
OxyContin abuse. In an effort to better educate the public, the
police department incorporated OxyContin, as well as other
prescription drugs of abuse, into its Heroin Education and
Dangerous Substance Use Prevention, or HEADS-UP program, which
educates middle to high-school age children, as well as parents
and community groups, in an hour-long presentation by police,
recovering addicts, and surviving family members of overdose
victims. Since April of 2001, this program was presented to
over 11,500 people.
There are currently significant investigations being
conducted by the Philadelphia Police Department and by joint
task forces with local, State, and Federal agents that deal
with OxyContin diversion. This is, however, a problem that we
cannot arrest our way out of. It will require a balanced blend
of prevention, treatment, and enforcement. It will also require
legislative changes to act as strong deterrents. There have
already been too many deaths. The attention that this committee
will hopefully bring to this problem is just the beginning of
the concerted effort needed to prevent future escalation. I
thank you for your attention, and I will be available to answer
any follow-up questions you may have.
[The prepared statement of Christine Coulter follows:]
Prepared Statement of Christine Coulter, Philadelphia Police Department
Good Afternoon, Mr. Chairman, honorable members of the Committee. I
am Christine Coulter of the Philadelphia Police Department's Narcotics
Bureau. I am assigned to the Narcotics Intelligence Squad. I am honored
to be here today to speak to you on behalf of the Philadelphia Police
Department regarding the abuse of Oxycontin in the communities we
serve. I must admit that prior to the fall of 2000 I knew very little
about Oxyconyin.
In the months to follow there was a concerted effort made by my
colleagues and myself to learn all that we could so we could better
combat this emerging problem.
I will leave the medical testimony for the medical professionals
regarding the legitimate use of Oxycontin. I am here today to testify
solely about the drug's abuse in Philadelphia and our surrounding
counties, and law enforcement efforts to combat this problem. The
effects of this abuse has been devastating to many families and
communities in our area.
The increase in deaths in Philadelphia where there was a presence
of Oxycodone in the body is quite alarming. The Office of the Medical
Examiner reported 17 cases in 1999, 41 cases in 2000, and as of June
30th, 2001 there were already 39 reported cases. This will likely
result in the death toll from abuse of this drug doubling in two
consecutive years. Although Oxycodone is present in other substances of
abuse, and there were indications that other pills and alcohol were
also contributing factors, we would be remiss to not react to the
increase with a sense of urgency.
The abuse of Oxycontin in Philadelphia is a rather recent
development. Beginning last year we began to experience some of the
problems that our fellow law enforcement officers in the surrounding
areas have dealt with for quite some time. The migration to the city
and surrounding suburbs happened quickly, necessitating the development
of a strategy that would stem the tide of Oxycontin abuse. We had to
quickly examine the areas of diversion so we could implement a suitable
plan to combat abuse.
An analysis was done and it was determined that there were three
major methods of diversion present in our city. The first is the
outright theft of the products, or prescription pads, from legitimate
patients, pharmacies, or practitioners, by relatives, employees, or
others, including burglars and robbers.
Second, individuals without legitimate medical necessity can obtain
Oxycontin by reporting made-up symptoms of pain to an unwary,
uneducated, or disinterested practitioner. This method is a low-risk
alternative for the pill diverter, since the prescription is issued in
the person's name, and often low cost as well, since medical insurance
normally covers most of the cost of the pill. This also engenders the
practice of ``Doctor-Shopping'', going from one doctor to another,
giving the same complaint, and getting the medications repeatedly
prescribed. It is not uncommon to do so using multiple names and
prescription plans, and having prescriptions filled at multiple
pharmacies to camouflage the fraudulent practice.
The third and often the largest diversion method are ``pill-mill''
operations, whereby corrupt doctors and/or pharmacists conspire with
pill traffickers to write or fill fraudulent prescriptions for
``ghost'' patients, and then selling the drugs on the street at up to
100% profit. There is also the presence of insurance fraud in this
diversion method, as health plans both private and governmental are
billed by providers for falsely reported office treatments and
prescriptions dispensed.
High volume operations such as ``pill-mills' lend themselves to
tracking by audits of physician records and pharmacy orders of commonly
abused controlled substances such as Oxycontin. Drug Diversion Agents
of both the Drug Enforcement Administration and the Pennsylvania
Attorney General's Office, Bureau of Narcotics Investigation and Drug
Control have the ability to administratively inspect and analyze such
records. There is currently a tremendous amount of cooperation with
these agencies, which enable us to build strong cases, while
eliminating duplication of efforts and wasted resources. Local law
enforcement, however, do not presently have the authority to
administratively subpoena prescription records. Enabling local police
officers to analyze these records will encourage a more proactive
investigation of drug diversion conspirators on the local level.
Coupled with aggressive prosecution and enhanced sentencing of licensed
health care professionals engaged in prescription drug diversion
schemes, it may also discourage such corrupt practices. There is also a
need for legislation to make all pharmaceutical thefts a felony,
factoring in the street value of the drug into the equation.
There was also a great need to train our officers as well as
educate health care providers and the public alike. Training bulletins
were prepared for officers and seminars were attended to gain insight
into the problems associated with Oxycontin abuse. In an effort to
better educate the public, the police department incorporated Oxycontin
as well as other prescription drugs of abuse into its Heroin Education
and Dangerous Substance Use prevention (or HEADS-UP) program, which
educates middle to high school age children, as well as parent and
community groups, in hour long presentations by police, recovering
addicts, and surviving family members of overdose victims. Since April
of 2001 this program was presented to over 11,500 people.
There are currently several significant investigations being
conducted by the Philadelphia Police Department and by joint task
forces with local, state, and federal agents that deal with Oxycontin
Diversion. This is however a problem that we cannot arrest our way out
of. It will require a balanced blend of prevention, treatment, and
enforcement. It will also require legislative changes to act as a
strong deterrent. There have already been too many deaths. The
attention that this committee hopefully will bring to the problem is
just the beginning of the concerted efforts needed to prevent further
escalation. I thank you for your attention. I am available for any
follow-up questions you may have.
Mr. Greenwood. Thank you very much for your testimony that
you bring us today, as well. And our final witness on this
panel is our Bucks County District Attorney, Diane Gibbons.
Thank you for joining us.
Ms. Gibbons. Thank you, Mr. Greenwood, and, Mr. Bass.
Mr. Greenwood. The floor is yours.
TESTIMONY OF DIANE E. GIBBONS
Ms. Gibbons. Bucks County, Pennsylvania, like so many
communities across this State and this country, has experienced
a virtual explosion of the abuse of the prescription pain
reliever OxyContin. As District Attorney of Bucks County, I
have witnessed firsthand the sudden influx of OxyContin and the
corresponding devastating effects this drug has had--has begun
to have on our community.
As has already been said, OxyContin is intended to be a
pain reliever for cancer patients and others suffering from
long-term debilitating pain. Its potency and time-release
design have made OxyContin more effective and desirable to
these patients. The popularity of the drug for legitimate
purposes is understandable and even compelling. But it is this
same potency that has become attractive to drug abusers. This
drug has become the drug of choice among an increasing number
of drug addicts who are drawn to its instantaneous heroin-like
high. Drug abusers will risk death to experience this high the
drug produces.
Since January of 2000, Bucks County has experienced 14
overdose deaths involving OxyContin. The drug is extremely
addictive and will, as with all addictive substances, create
new drug addicts if overly or improperly prescribed. In
addition to its popularity among drug abusers, the high mark-up
on the streets makes OxyContin attractive to drug traffickers
as well. The retail cost of a 100-tablet prescription bottle
containing 40-milligram tablets of OxyContin, is $400. The
pills in that same prescription bottle sold on the street, are
worth $4,000.
The abuse of OxyContin has brought with it a new kind of
drug dealer to our neighborhoods. This drug is not manufactured
in home laboratories like methamphetamine. It is not smuggled
across our borders like heroin or cocaine. This drug is
produced by a legitimate pharmaceutical company. It is
prescribed by medical doctors. It is distributed by
professional pharmacists. These are the professionals that we,
as lay people, have come to trust and believe in. Recently, the
citizens of Buck County have experienced two separate incidents
that have left the foundation of this trust badly shaken.
In March of this year, acting in a cooperative effort with
the Attorney General, DEA, and other local law enforcement
authorities, we arrested a physician operating out of Bensalem
Township, Bucks County, on drug dealing, forgery, practicing
without a license charges. This ``physician'' is charged with
having written 1,200 prescriptions for OxyContin over a 5-month
period. We recently charged the same physician with 1,392
counts of insurance fraud for fraudulently submitting claims
for reimbursement from Medicare and Blue Cross in the amount of
$173,892.10.
Despite the fact that this doctor's license to practice
medicine had both expired and was suspended, large numbers of
people were able to obtain OxyContin by merely asking for a
prescription. One prescription bottle with this doctor's name
on it was found in the possession of an overdose victim in
Philadelphia. Following his arrest--and this--I refer to Dr.
Paolino--the OxyContin overdoses in that area of Philadelphia
immediately ceased. Despite the expired and suspended status of
his license, Dr. Paolino was able to receive reimbursement from
both Medicare and Blue Cross in the amount of $107,702.
In April of 2001, in another joint investigation, a
pharmacist was arrested and charged with forging prescriptions,
the majority of which were for OxyContin. Again, hundreds of
these illegal prescriptions were generated, thereby allowing
this illegal and deadly drug to make its way to our streets.
A third and very frightening incident occurred on August 9
of 2001, in Bristol Township, Bucks County. On that date, a
man, armed with a knife, entered a pharmacy, held a knife to
that pharmacist and demanded that the pharmacist turn over
three bottles of OxyContin. Fortunately, the pharmacist was
able to flee the store without injury while the armed robber
collected the drugs that he sought.
Too often, as a society, we think that drug abuse and drug
addiction is someone else's problem, not ours. Those of us here
and those of us in law enforcement understand that nothing
could be further from the truth. These three incidents, which
occurred at Bucks County over the last 6 months, indicate the
kind of criminal activity OxyContin has created, not only here,
but on a national level as well. But they do not demonstrate
the whole picture.
Drug addicts, by definition, must become criminals to
support their habit. The tremendous costs to support the
addiction leads to a host of crimes--theft, forgery, credit
card fraud, robbery, burglary, and murder. Drug dealers engage
in a host of crimes beyond the sale of controlled substances in
order to protect their drug territory.
The people of Bucks County and across the Nation will
suffer the impact of the abuse of this drug, not only as
victims of crimes, but in the cost of insurance and the cost of
retail goods and the added expense to the criminal justice
system for arrest, investigation, prosecution, and treatment.
The reaction of law enforcement must be swift and strong in
identifying, arresting, prosecuting, and convicting those
involved in the distribution and use of this dangerous drug. My
office and every other law enforcement agency in Bucks County
and in the Commonwealth of Pennsylvania, are committed to
utilize every resource available to combat this killer. But the
criminal justice system alone cannot solve this problem. It
will require the cooperative effort of the pharmaceutical
industry, medical practitioners, pharmacists, the insurance
industry, and government to fully regulate and control the
distribution of this extremely dangerous drug.
In conclusion, I want to say this--law enforcement has
worked very closely to stem the tide of this problem in Bucks
County. All the officers, the law enforcement officers here
today, worked with me on all the cases that I mentioned. What
has not occurred is that the medical profession, the
prescription--the pharmacists, the insurance companies have not
worked together to share information. Dr. Paolino was able to
engage in his criminal conduct for 5 months without detection
because we do not share information about prescriptions, what
doctors are writing prescriptions, and how many prescriptions
those doctors are writing. So I think there is an answer to
this problem. Thank you very much.
[The prepared statement of Diane E. Gibbons follows:]
Prepared Statement of Diane E. Gibbons, District Atttorney, Bucks
County
Bucks County, Pennsylvania, like so many communities throughout the
country has experienced a virtual explosion of the diversion and abuse
of the prescription pain reliever OxyContin. As District Attorney of
Bucks County, I have witnessed first hand the sudden influx of
OxyContin and the corresponding devastating effects that this drug has
begun to have our community.
OxyContin is intended to relieve the pain of cancer patients and
others suffering from long-term debilitating pain. Its potency and
time-release design make OxyContin more effective and desirable to
these patients. The popularity of the drug for legitimate purposes is
understandable and even compelling. But it is this same potency that
has become attractive to drug abusers. This drug has become the drug of
choice among an increasing number of drug addicts who are drawn to the
instantaneous ``heroine-like'' high the pill produces. Drug abusers are
willing to risk death to experience the high the drug produces. Since
January of 2000, Bucks County has experienced fourteen overdose deaths
involving OxyContin in combination with other controlled substances.
This drug is an extremely addictive drug and will, as with all
addictive substances, create new drug addicts if overly or improperly
prescribed. In addition to its popularity among drug-abusers, the high
mark-up on the streets makes OxyContin attractive to drug traffickers.
The retail cost of a 100-tablet prescription bottle of 40-milligram
tablets of OxyContin is $400. The pills in that same prescription
bottle, sold on the streets, are worth $4,000.
The abuse of OxyContin has also brought with it a new kind of drug
dealer to our neighborhoods. This drug is not manufactured in home
laboratories like Methamphetamine or smuggled across our boarders like
Heroine and Cocaine. This drug is produced by a legitimate
pharmaceutical company, prescribed by medical doctors and distributed
by professional pharmacists. These are the professionals that we, as
lay people, have come to trust and believe in. Recently, the citizens
of Bucks County have experienced two separate incidents that have left
the foundations of this trust badly shaken.
In March of this year, acting in a cooperative effort with the
Attorney General of Pennsylvania, Mike Fisher, we arrested a physician
operating out of Bensalem Township, Bucks County, on drug dealing,
forgery and practicing without a license charges. This ``physician'' is
charged with having written over 1,200 prescriptions for OxyContin over
a five-month period. We recently charged the same ``physician'' with
1392 counts of insurance fraud for fraudulently submitting claims for
reimbursement from Medicare and Blue Cross in the amount of
$173,892.10. Despite the fact that this doctor's license to practice
medicine had both expired and been suspended, large numbers of people
were able to obtain OxyContin by merely asking for a prescription. One
prescription bottle with this doctor's name on it was found in the
possession of an overdose victim in Philadelphia. Following his arrest,
the OxyContin overdoses in that area of Philadelphia immediately
ceased. Despite the expired and suspended status of his license, this
doctor was able to receive reimbursement from both Medicare and Blue
Cross in the amount of $107,702.
In April of 2001, in another joint investigation with the Office of
the Attorney General, a pharmacist was arrested and charged with
forging prescriptions the majority of which were for OxyContin. Again,
hundreds of these illegal prescriptions were generated thereby allowing
these illegal and deadly drugs to make their way to the streets.
A third and very frightening incident occurred on August 9, 2001 in
Bristol Township, Bucks County. On that date, a man armed with a knife,
entered a pharmacy, pointed the knife at the pharmacist's throat and
demanded that he turn over three bottles of OxyContin. Fortunately, the
pharmacist was able to flee the store without injury while the armed
robber collected the drugs he sought.
Too often, as a society, we think of drug abuse and addiction as
somebody else's problem, not ours. Those of us in law enforcement know
that nothing could be further from the truth. These three incidents,
which occurred in Bucks County over the last six months, indicate the
kind of criminal activity OxyContin has created not only here but also
on a national level. But they do not demonstrate the whole picture.
Drug addicts by definition must become criminals to support their
habit. The tremendous cost to support the addiction leads to a host of
crimes--theft, forgery, credit card fraud, robbery, burglary and
murder. Drug dealers engage in a host of crime beyond the sale of
controlled substances as they try to protect their territory. The
people of Bucks County and across the nation will suffer the impact of
the abuse of this drug not only as victims of crime but in the cost of
insurance and retail goods and the added expense to the criminal
justice system for investigation, prosecution, incarceration and
treatment.
The reaction of law enforcement must be swift and strong in
identifying, arresting, prosecuting and convicting those involved in
the distribution and use of this dangerous drug. My office and every
law enforcement agency in Bucks County are committed to utilize
whatever resources are available to combat this killer. But the
criminal justice system alone cannot solve this problem. It will
require the cooperative effort of the pharmaceutical industry, medical
practitioners, pharmacists, the insurance industry and government to
fully regulate and control the distribution of this extremely dangerous
drug.
Mr. Greenwood. And thank you very much for your testimony.
We appreciate it. The Chair now recognizes himself for 10
minutes for the purpose of questioning the witnesses. And let
me start, if I might, with Mr. Woodworth. According to the DEA,
since its introduction in 1996, OxyContin prescriptions have
increased by 1,800 percent to 6 million in the year 2000. How
do you account for this incredible growth of sales in only 4
years, and do you think that Purdue Pharma's marketing
techniques are a factor in this dramatic rise?
Mr. Woodworth. Thank you, Mr. Chairman. The product was
new. So I think a significant factor is the newness of the
product. It's a very valuable, legitimate medication, used in
the treatment of pain. And I am sure that that is a significant
factor that contributed to the rapid increase in sales from
about 360,000 to, as you say, just under 6 million
prescriptions.
I do think that the marketing played a significant role.
And coupled with the marketing, was the message. And the
message was that this substance was less abusable than other
opioids. And, as defined by the Controlled Substances Act, a
Schedule II substance, which all your stronger narcotics are in
Schedule II, they have a high potential for abuse, severe
physical and psychological dependence characteristics.
Mr. Greenwood. Let me interrupt you for a second. Would you
elaborate on the message that you said that Purdue Pharma
communicated to the physicians that this was a less abusable
drug? What was the argument there?
Mr. Woodworth. In fact, in their label, which has now being
changed, I believe the language was delayed absorption is
believed to reduce the abuse liability, and messages like that.
We also have indicators from--about Purdue salesman indicating
that the substance has less abuse and should not be a Schedule
II controlled substance. And that message is inaccurate because
this is a Schedule II and it meets the definitions by law. I
think that was a contributing factor.
Mr. Greenwood. Also according to the DEA, emergency
department reports involving Oxycodone, the generic active
ingredient, had increased 200 percent since 1996. In addition,
coroner reports involving Oxycodone have increased 400 percent
since 1996. Do you know how much of this is attributable to
OxyContin?
Mr. Woodworth. No, sir. We don't. The time period that we
utilized was the same time period that the product has been on
the market, from 1996 to 1999. And I can give you some 2000
figures for emergency room mentions. The 200 percent was
inaccurate. It increased from 3,190 mentions in 1996 to 6,429
in 1999. It is a doubling. The ME's was from 51 to 267, 400-
percent increase.
The emergency department mentions, for a number of years,
from 1988 to 1996, have run fairly stable, about 1,000 mentions
per quarter. And in 1996, you see them shoot up. And then in
2000, there were 10,800 emergency mentions. So this is----
Mr. Greenwood. Re-read those numbers again. Between 1988
and 1996--and define what you mean by a mention in an emergency
department.
Mr. Woodworth. Actually, an episode is the correct term.
This is the Drug Abuse Warning Network that is managed by the
Department of Health and Human Services, Substance Abuse and
Mental Health Services Administration. And an emergency
department episode is largely self-reported, where someone goes
to the emergency room and they are asked the drug that they are
on. The mentions from 1988 through 1996 were roughly 1,000 per
quarter during that time period. And in 1996, as I mentioned,
they went to 3,190. And then they increased in 1999 to 6,429.
And in 2000, they are at 10,825, I believe.
Mr. Greenwood. So a tenfold increase in the number of times
that Oxycodone----
Mr. Woodworth. The base substance, Oxycodone.
Mr. Greenwood. [continuing] Oxycodone is referenced in a
visit to. It comes up in a conversation with someone brought to
the emergency room. In other words, what drugs did you take
before you were brought here semiconscious or unconscious and
so forth. So we have these numbers of deaths, but we are seeing
a tenfold increase. And obviously a lot of people abuse this
drug, overdose from this drug, and that doesn't result in their
death. They are coming to the emergency room in various
conditions, a tenfold increase in seeing the presence of this
drug associated with emergency room visits. Is that right?
Mr. Woodworth. Emergency room, emergency department
episodes. Yes, sir. On the deaths, in the DAWN system, it was
just 51 in 191996, and then 267 in 1999. DEA is writing to each
medical examiner throughout the country to obtain the autopsy
and toxicology reports and the crime scene investigation in
order to see if we can more accurately determine whether the
percentage of Oxycodone deaths that were attributable to
OxyContin.
Mr. Greenwood. You have been quoted in the press as being
highly critical of Purdue Pharma's slow response to the abuse
of OxyContin. In particularly, when asked if the company should
have investigated adding antagonists to OxyContin to prevent
abuse, you stated, ``It should have dawned on them sooner.''
What should the company have done sooner to prevent all this
abuse?
Mr. Woodworth. Well, I have been involved in this business
for 30 years, working with the pharmaceutical industry here in
the United States for that entire time. Purdue is an
outstanding company and they have been in business making pain
medications for a long time. They possess some of the best
scientific and pharmaceutical knowledge and expertise that
exists in the world. I just find it very difficult to believe
that that situation wasn't addressed earlier.
Mr. Greenwood. Can you elaborate on that? What might they
have done? My question to you is what should they have done
sooner? Is there any question in your mind that they knew that
they had a problem early on, prior to the year 2000? For
instance, that they knew that this drug was being abused in
unprecedented levels? That this drug was causing death? That
this drug was on the streets? Any question in your mind that
the company should have known that, certainly, 2 years ago?
Mr. Woodworth. There certainly was no question in my mind,
and I believe that that would be the same case for Purdue
Pharma.
Mr. Greenwood. That they were aware of it. How long have
you personally been aware of the fact that this drug was having
an alarming rate of abuse?
Mr. Woodworth. Well, it is difficult to define alarming.
Now, DEA had a case in 1996, soon after it came on the market,
in Richmond, Virginia. Another three or so cases in 1998. In
1999, a half dozen, including some here in Pennsylvania. And
then 37 in 2000, and now we are up to 168 cases. And that is
just DEA at the Federal level. It doesn't include our State and
local counterparts.
Mr. Greenwood. Let me turn to this side of the table to
District Attorney Gibbons. You have characterized distributors
of OxyContin as ``a new kind of drug dealer.'' And while you
cite the recent arrests of a doctor and a pharmacist, are these
abuses by such professionals isolated incidences or do you have
reason to believe that this is more common?
Ms. Gibbons. It is not going to be isolated. I mean, this
is a drug that is not manufactured by lay people. It is not
made in local labs. It is not grown. It is not imported. For
this drug to be abused, it must come from a legitimate source.
It must come from the manufacturer or from a doctor or from a
pharmacist. The mere fact that we have seen this amount of this
drug on the street, means that that is, in fact, happening. And
it is not one doctor in Bensalem, Bucks County, but the number
of pills that are causing these numbers of deaths on--in the
market. Of course, there is going to be prescription fraud,
but, as we have seen, pharmacists have conspired with that.
There will be robberies to commit these crimes. Bucks County
has not seen so much a forcible crimes to obtain the pills, so
much as a greedy distribution of these pills on the street for
money.
Mr. Greenwood. Let me yield 10 minutes to the gentleman
from New Hampshire, Mr. Bass.
Mr. Bass. Thank you very much, Mr. Chairman. Ms. Gibbons, I
note that you mentioned in your testimony that this drug has
the potential to have a devastating impact, and I agree with
you, also tempered by the fact that it has provided, as you
well understand, tremendous relief to perhaps hopefully many
more people. You also mentioned that--an example that there was
a physician that wrote 1,200 prescriptions. Now, that is not
really the fault of the drug company necessarily directly.
In your opinion, what action do you think should have been
taken and should be taken, or a corrective action to be taken
to prevent this sort of thing from happening again, and
starting, perhaps, with the manufacturer and going down
through, in this case, the State of Pennsylvania and into the
Federal level?
Ms. Gibbons. We--you are absolutely correct. We--my mother
passed away of cancer. I would have loved to have this kind of
pain pill to make her last days better for her. But given the
fact that it is being abused, and we know it is being abused,
and this company, as the chairman says, has got $1.2 billion in
sales. There is things we can do and I think they have to
contribute to it. And one of those things is to monitor the
distribution of those pills.
It is hard for me to track down a meth lab because I don't
know where the meth lab is. Is it in the Poconos? Is it in
Upper Bucks County? But I know where this drug is coming from.
And given the fact that the source of this drug comes from one
sole source, it should be easy, very easy, to track the
distribution of that drug. And that requires sharing of
information among the different organizations, the medical
profession, the drug company, the pharmacies, having access to
DEA's information, and, as Christine said, my ability to go
into a pharmacy and do some kind of audit.
One of the questions I could not answer when I announced
the insurance fraud arrest of Paolino and the drug dealing
arrest, was average citizens can see this. It is common sense.
A guy came up to me and said, wait a minute. If the guy doesn't
have a license to practice law--or to practice medicine, I
mean, how come pharmacies are still filling his prescriptions?
And how come the insurance companies are still paying his
claims? And it is a simple matter of fact that we don't share
information.
Law enforcement shares information. I worked with every one
of these law enforcement authorities to arrest both the
pharmacist and the medical doctor. But the license status of
this doctor was never shared with the people who were filling
his prescriptions and the people who were paying his bills.
And I think if we set up a system, given the fact that we
know the source of the drug--you know, where is the drug going?
What doctors are prescribing what amounts? Is that doctor
properly licensed? You know, is the pharmacy properly
accounting for its 500 pills or 5,000 pills, or whatever it has
in its local stores? Law enforcement could have been keyed into
this particular problem months before we actually were able to
find out that this doctor and this pharmacy were doing this.
Mr. Bass. Mr. Demarest, you mentioned in your testimony
that--if I could paraphrase, that you seem to be able to get
just about all the information you really need. On the other
hand, there isn't a conflict, but Ms. Coulter mentioned that
she didn't have--it wasn't as easy to get--I am not sure--and
maybe it was Ms. Gibbons that mentioned this. And I am just
curious to know, do you have access to the records and
information that you need in order to adequately monitor the
situation with respect to the abuse of this drug or any other
prescription drug subject to abuse?
Mr. Demarest. Congressman, the monitoring system of drugs
depends from State to State because there is the Federal aspect
and then there is the State aspect. The Federal aspect is
covered by ARCOS, which is an electronic computer system that
is run by DEA. DEA covers the sales of narcotics and other
Schedule II drugs to pharmaceutical chains from wholesalers, or
to doctors that are dispensing the drugs.
In the State of Pennsylvania, we have a system where we are
able to monitor only Schedule II drugs. That would be--one of
them which would be Oxycodone or OxyContin. So we would have a
manual data base with all 3,500 pharmacies in the Commonwealth
reporting this every month, how many Schedule II prescriptions
they have. There are over 2 million of those types of
prescriptions issued a year. And with Pennsylvania senior
population increasing, we are seeing an increase, too, in
general narcotic type of prescriptions. So those prescriptions
are now manually capped.
Other States monitor both the Schedule IIIs and the
Schedule IVs. Schedule III is also a problem. That is Vicodin
or Hydrocodone. That, before OxyContin hit the front page, was
really a major problem. So that drug in Pennsylvania is not
monitored by law enforcement. So, to answer your question, we
should have OxyContin prescriptions monitored. We are now
developing a computer system that will get that data directly
from the pharmaceutical chains. But all 3,500 pharmaceutical
outlets have different technologies and to allow to dump that
data to the State. But we are making substantial headway.
Mr. Bass. Ms. Coulter, you stated that the Bureau of
Narcotics Investigations and Drug Control has the ability to
inspect and analyze physician records and the pharmacy orders.
I am wondering if these inspections are routine or are they
triggered by certain factors? And is it done in such a manner
as to protect patient privacy?
Ms. Coulter. Right. See, the local law enforcement does not
have that right right now. The State does, but local cannot.
And I just feel that with that right, it would prohibit someone
who may get involved in corrupt activities from even getting
involved. If they knew that--there are so many pharmacies. I
mean, there is one on every other corner in Philadelphia. But
if they knew that the local law enforcement agents could come
in and check them, it may just be another check in the system
to keep them from being involved in that.
I realize and recognize the patient's rights, and I think
that is very important. But from--to just look at the scope of
what is being prescribed, if you have specific pharmacists that
are not necessarily next to Fox Chase Cancer Center, or
somewhere where there should be a higher increase, it would be
nice to know that just to ensure that, you know, we are
protecting the community that surrounds that area.
Mr. Bass. Well, I guess, Mr. Chairman, if I could, I have
just three more questions for Mr. Demarest. You represent the
Attorney General in the State of Pennsylvania. And it is--is it
your feeling that Purdue Pharma has taken appropriate action in
response to increased reports and evidence of growing abuse of
their product?
Mr. Demarest. Congressman, I think there are a few things
that they did well. And one of those was to distribute the
tamper-proof prescription pads, which I think was well-taken.
Some States took that measure on their own prior to that
problem, but Purdue has made that available to other States.
I guess the real issue comes down to the marketing of the
actual product. And, as you are aware, there was, for example,
pens given out comparing dosage qualities--quantities to
certain other drugs that are a substantially lower schedule.
One, Propoxyphene or Darvocet, a Schedule IV--the pen that
Purdue gave out compares it to OxyContin.
Mr. Bass. What is a pen? Do you mean the thing you----
Mr. Demarest. Here it is. It is an actual----
Mr. Bass. Okay.
Mr. Demarest. Here it is. It would----
Mr. Bass. All right. It is an advertising--it is
advertising.
Mr. Demarest. Can you show him?
Mr. Bass. Okay.
Mr. Demarest. I have never--I have only looked at kind of
photos.
Mr. Woodworth. It has OxyContin on blue on the side of it.
It has a little scroll that you pull out and it says how to
convert patients to OxyContin. And on the flip side it tells
you the other substances that you can use to do that, including
Darvocet, which is a Schedule IV, Tylenol with Codeine. And so
that is the message that we are talking about.
Mr. Demarest. And that is a concern because the drugs,
while they are both painkillers, to use a generic term, they
are different in how they have been ranked, as far as abuse
potential goes.
Mr. Bass. Well, are you suggesting that advertising for
Schedule II drugs be regulated differently?
Mr. Demarest. I think it----
Mr. Bass. I mean, that is all that is, is an advertisement.
Right?
Mr. Demarest. That is correct. And you still have the
corresponding duty of the physician when they write that
prescription for the patient. But, as we know, there is a
reason why drug companies market, because it impacts on sales.
Mr. Bass. Sure.
Mr. Demarest. So there is a symbiotic relationship between
the marketing the product reaching the streets.
Mr. Bass. I have no further questions, Mr. Chairman.
Mr. Greenwood. Thank you. The Chair recognizes himself for
an additional 10 minutes. I direct a question to you, Mr.
Meehan. From your experience in Delaware County, can you give
this committee a sense of the profile of the abusers in your
county, both those that have died as a result of their abuse,
and to the extent that you are aware of others who had close
calls and ended up in the emergency rooms and so forth? I am
trying to get a sense whether these are hardened long-time drug
abusers who are shifting from a more expensive drug or a more
criminalized drug or a hard-to-get drug, and have found
OxyContin to be just the next phase in their chronic abuse of
drugs, as opposed to young people. Again, I reference a
gentleman I spoke with just before the hearing, whose family's
18-year-old son got in the unfortunate practice of doing pill
popping with friends not realizing, as the gentleman said to
me, one drug plus one drug doesn't equal two. And, in this
case, one plus OxyContin equals ten, in terms of the dangers.
What can you tell us about the profile of the people you see
abusing this drug in your county?
Mr. Meehan. I think that there is a dichotomy and I think
you have accurately identified it. Among the 26 deaths or the
25 deaths that we analyzed in the most recent years,
predominantly we saw people who had a history of drug abuse.
And, as I indicated before, those who died often died not only
with Oxycodone as one of the ingredients, but some other kind
of abused drug as being part of it.
And I have often focused on the fact that that is an abuser
population who may have actually found this as an alternative
to other kinds of abused drugs. And it may, at the outset, be
something that is an alternative to heroin. For an abuser, it
has that rush-like quality that is something that is consistent
with heroin. And, as a result, there is a defined abuser
population.
My concern is the extent to which we are generally seeing
it move beyond the abuser population and into what we call the
recreational drug area--the rave scene, the club scene. And we
know it. My detectives are out on the street and they see it.
And the kids are now carrying it in the clubs. And it is not
just GHB and Ketamine and Ecstasy. It is now, in addition,
OxyContin. And the biggest concern we have is the generally
addictive nature of the drug.
Mr. Greenwood. Let me turn back to Mr. Woodworth for a
second, from the DEA. My understanding is that there is a
private data base, and you help me understand this, that
records the prescriptions per physician for these Schedule II
drugs. And that data base--I know that the company will have
them here shortly. The company has a data base. They know every
physician in the country that is writing prescriptions for this
OxyContin and they can--they have a data base that they get
from--well, I understand it is a private source that--and then
they can arrange that data to start to show who are the
physicians that are prescribing the most and rank them.
To what extent does DEA have access to that kind of
information?
Mr. Woodworth. As you mentioned, Mr. Chairman, it is a
private company, IMS Health. And DEA purchases prescription
information from this company. And we do so on a fairly regular
basis from several of their different data bases, the National
Prescription Audit and the National Therapeutic Index, on a
fairly regular basis to do that type----
Mr. Greenwood. And what do you do with--I know here in
Bucks County we had Dr. Paolino, who is as bad an actor as you
can find. The guy has gone bankrupt. He has got sexual
harassment cases going. He has lost his license. He is
practicing without a license. And he essentially ends up
selling prescriptions at whatever it was, $69 or $60 a pop to
walk in the doors. When DEA, when your people came in, he had a
standing room only office of zombies trying to get their hands
on the next prescription. Now, does DEA--or should DEA have,
from this data base, been able to see the Dr. Paolinos of the
world who were doing 1,200 scripts in, what was it, a month,
1,200 prescriptions in--over 5 months for this particular
addictive substance?
Mr. Woodworth. No, sir. The information in that data base
is not provided by name, so we would have no idea of the
physician.
Mr. Greenwood. So then what does it say? What does this
information tell you, just the total gross number of
prescriptions?
Mr. Woodworth. We rate them--rank them by the number of
prescriptions per State.
Mr. Greenwood. Per State.
Mr. Woodworth. So that is what we would be able to do for
Pennsylvania, provide the State and local authorities with the
number of prescriptions.
Mr. Greenwood. Okay. But that does not come down to the
physician level.
Mr. Woodworth. No, sir. Under the Controlled Substances
Act, that responsibility was specifically relegated to the
individual States to address the retail level, doctors, and
pharmacies. That information would be provided not in the
numeric detail to our State and local counterparts. It would be
a profile of the trends.
Mr. Greenwood. Okay. Let me ask, perhaps, a final question
for Ms. Gibbons. In the 14 overdose cases in Bucks County since
January of 2000. These are 14 overdose cases with OxyContin.
Ms. Gibbons. Involving--in each case, there were other
substances involved.
Mr. Greenwood. And that is what I want to get a sense of.
Can you shed a little light on what the profile is in Bucks
County, if you will, or at least to what extent there were
other drugs present, alcohol present in the decedent's body?
Ms. Gibbons. Well, we--I don't know the specifics in terms
of what the--what was determined at the autopsy. I do know in
each case it was not just OxyContin. There were other things
involved. It is difficult to come up with a profile in Bucks
County. You know, I have been in the DA's office in Bucks for
18 years. I was not even aware of OxyContin until 2000. And I
think that the same--the medical examiner would say the same
thing. So we don't have enough experience to know if this is--
to determine any kind of trends.
I can say, you know, as Pat did, that we have made arrests
of sales of OxyContin out of bars. So it will hit the general
street population and it will hit the recreational user. There
is no doubt about it. Percocet did. OxyContin will go the same
way.
Mr. Greenwood. Maybe I will ask Ms. Coulter the same kind
of question in terms of--that I have asked Mr. Meehan and now
Ms. Gibbons. In terms of the profile of the people that you see
using the drug, in terms of--I think we have heard a consistent
theme here, that the fear is that this is a drug that may be
working its way from the hardened, chronic drug abuser who
finds that the next cheapest, easily accessible, profitable, if
you will, drug to use, to the kids who are experimenting and
may find themselves taking the fatal dose, and what they expect
is just a recreational kind of a lark.
Mr. Coulter. That is pretty much what we are seeing in
Philadelphia. We are seeing recreational use within the 15 to
25-year range. We are seeing it on other levels as well. But it
is the most disturbing because I really feel that the people
who are experimenting really feel it is safe because it is a
pharmaceutical.
Like when we debrief prisoners or people who are arrested
for either possession or selling, there isn't that sense that
it is heroin or it is something that is dangerous, because it
is made by people who are doctors. It is not a danger, like
street-level drugs, that you don't know what you are getting in
the heroin pack. That they really feel they are getting a safe
product. And the street corner sales are absent all of the
necessary warnings that are provided when you buy it and use it
legitimately. And----
Mr. Greenwood. Do these kids seem to have any concept that
others who have come before them are dying? In other words, I
suspect that these 15, 16, 17, and 18-year-old kids are not
picking up the Philadelphia Inquirer every morning or watching
the nightly news and following these events. Are they surprised
to find out how dangerous these drugs are?
Ms. Coulter. You know, they are not surprised how dangerous
they are, but I think they are still at that age where they
really feel they are invincible, that it will only happen to
somebody else and that this isn't going to happen to me because
I am not going to take the highest milligram or I am not going
to mix it with two drugs; perhaps I will only mix it with one.
But just alcohol alone, or the pill itself, you know, used
improperly, has that same deadly affect. But it seems very hard
to reach that age.
And that is why we have incorporated it into our HEADS-UP
program where we are starting at the middle school level where
they don't have that invincible nature yet, that they still
will learn what it is and what could happen if you did it just
once. And that is what we are trying to communicate, that a lot
of our fatalities weren't life-long abusers, that they are
people who have tried it once or twice, or mixed it with
another drug or alcohol and it had deadly results.
Mr. Greenwood. Okay. Thank you. Mr. Bass, any other
questions at this time?
Mr. Bass. No, Mr. Chairman. I just wanted to advise, as you
well know, I am going to have to leave in about an hour. I hope
that our next Panel of witnesses, because they do represent a
different part of this whole issue, will be able to give this
subcommittee a good idea as to exactly what OxyContin is and
how it compares to Schedule I drugs, which apparently--which
have no medical use. And what we have gotten into with this
line of questioning here is really the issue of a Schedule II
drug which has good medical applicability getting into the
category, one way or another, of Schedule I. And how these
people who come about it from a different--not from the law
enforcement side, propose that, you know, the State and Federal
authorities deal with the problem. And I yield back.
Mr. Greenwood. Let me just offer that the panelists, if
there is any of you who feel that there is a point that you
haven't made that you want to get across, something that this
committee should know--have we asked you all the right
questions? Are there other comments or statements you felt you
need to--to help us put on the record?
Ms. Gibbons. I just want--I would like to make one
statement because this is in Bucks County, and I know it is
going to hit my media and I am worried about this. I understand
that most of the deaths occurred because they were in
combination with other drugs. But I don't want the message to
go out to other kids that, you know, the kids--hey, I can take
it as long as I don't take it with something else. I am going
to be safe. Because that is not the case. They could die with
the pill alone. They could die with alcohol. And while our
experience has been other drugs were involved, I don't want to
send the message that if other drugs aren't involved, they are
okay.
Mr. Greenwood. And that is an excellent point, and I thank
you for making it. And I thank each of the witnesses for being
with us today and for your testimony and you are now excused.
Thank you.
We will now call forward our next panel of witnesses. And
they are Michael Friedman, Executive Vice President and Chief
Operating Officer of Purdue Pharma.
Okay. If we can resume order here. Our next panel consists
of Michael Friedman, Executive Vice President and Chief
Operating Officer of Purdue Pharma. We would call him forward.
As well as Michael Levy, Dr. Michael Levy, M.D., and Ph.D, Vice
Chairman of Medical Oncology, Director of Supportive Oncology,
and Director of the Pain Management Center at the Fox Chase
Cancer Center; Terry Atwood, Registered Nurse; and Dr. John
Jenkins, Director of the Office of Drug Evaluation, The Center
for Drug Evaluation and Research Food and Drug Administration.
And I would ask the audience to please take your seats
again and desist from conversations, please, so that we can
have the attention of our witnesses. Thank you, each of you,
for being with us. You are aware that this committee is holding
an investigative hearing. And when we do so, we have had the
practice of taking testimony under oath. Do any of you have
objections to testifying under oath? Seeing no objections, the
Chair then advises you that under the rules of the House and
the rules of the committee, you are entitled to be advised by
counsel. Do you desire to be advised by counsel during your
testimony today?
Mr. Friedman. Yes, Mr. Chairman. I am advised by Mr. Howard
Udell and Dr. Paul Goldenheim. It is my intention to defer to
my colleagues when you or the Congressman Bass have questions
relating to their areas of responsibility.
Mr. Greenwood. In that case, when I swear the witnesses in,
your counsel who will be advising you will be asked to take the
oath as well.
Mr. Friedman. Thank you, Mr. Chairman.
Mr. Greenwood. Anyone else who wished to be advised by
counsel? All right. In that case, if you would please rise and
raise your right hand, I will swear you in, and that includes
any counsel who will be advising.
[Witnesses sworn.]
Mr. Greenwood. Okay. In that case, you are under oath. And
ask you to please be seated. And we will begin by calling
Michael Friedman from Purdue Pharma for his testimony.
TESTIMONY OF MICHAEL FRIEDMAN, EXECUTIVE VICE PRESIDENT, CHIEF
OPERATING OFFICER, PURDUE PHARMA, L.P., ACCOMPANIED BY HOWARD
UDELL, EXECUTIVE VICE PRESIDENT AND GENERAL COUNSEL, AND PAUL
D. GOLDENHEIM, SENIOR PHYSICIAN; MICHAEL H. LEVY, VICE CHAIRMAN
MEDICAL ONCOLOGY, DIRECTOR OF SUPPORTIVE ONCOLOGY, DIRECTOR,
PAIN MANAGEMENT CENTER, FOX CHASE CANCER CENTER; THERESA
ATWOOD; JOHN JENKINS, DIRECTOR, OFFICE OF DRUG EVALUATION II,
CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG
ADMINISTRATION
Mr. Friedman. Thank you, Mr. Chairman. My name is Michael
Friedman and I am the Executive Vice President and the Chief
Operating Officer of Purdue Pharma, the distributor of
OxyContin tablets and other medications. My responsibilities at
Purdue include the direct oversight and management of sales,
marketing, human resources, licensing, and business
development.
With me today, and available to answer the committee's
questions, are Mr. Howard R. Udell, our Executive Vice
President and General Counsel, and Dr. Paul D. Goldenheim, the
Senior Physician at Purdue. Dr. Goldenheim is responsible for
all research, development, and both regulatory and medical
affairs at our company. Mr. Udell has the primary
responsibility for the company's U.S. legal affairs.
Before I begin my brief remarks, I ask to place on the
record my entire opening statement for the hearing record,
along with two accompanying annexes to my remarks, which are in
the committee's possession and available at this hearing.
Mr. Greenwood. Without objection, those documents will be
entered into the formal record.
Mr. Friedman. Thank you, Mr. Chairman. On behalf of Purdue
Pharma, L.P., the distributor of OxyContin tablets, thank you
for taking the time to hold this hearing. We are more
distressed than anyone at this hearing that our product, which
is providing so much relief to so many people, is being abused.
The availability of OxyContin is critical for millions of
patients who are suffering from moderate to severe pain where a
continuous around-the-clock analgesic is needed for an extended
period of time.
Unfortunately for those patients, concern generated by the
abuse of OxyContin has mushroomed to the point that in some
locations, some patients are asking their doctors to switch
them to less effective medicines, some doctors are refusing to
renew patients' prescriptions for OxyContin, and some
pharmacists are no longer willing to carry OxyContin for their
patients. Purdue receives alarming reports every day from such
physicians and patients. For these patients in pain, this
hearing is timely and important.
Today's hearing should focus on a significant question of
public health policy--how to address the problems of abuse and
diversion which accompany the sale of controlled prescription
drugs like OxyContin without restricting its availability to
meet the needs of doctors and patients for the effective
management of pain? This question is neither new nor unique to
OxyContin. It has existed as long as opioid analgesics have
been available. It is a critical question, and we are confident
that Purdue has devoted more resources and efforts than any
pharmaceutical company in attempting to answer this question.
Purdue has provided, and continues to provide, extensive
assistance to the law enforcement communities and medical
communities in preventing and policing the abuse of OxyContin.
While all of the voices in this debate are important, we
must be especially careful to listen to the voices of patients
who, without drugs like OxyContin, would be left suffering from
their untreated or inadequately treated pain. Purdue frequently
hears stories of how OxyContin has enabled people to return to
their families and to productive lives after suffering
disabling pain. We urge you to hear directly from some of these
patients at future meetings. They are not addicts. They are not
criminals. They are people who, because of cancer, sickle cell
anemia, severe back injuries, or some other physical insult or
disease, have had their lives taken away from them by
unrelenting pain.
Amidst all the publicity and controversy, a few facts do
stand out. First, the problem of chronic pain in this country
is enormous and it is expensive. According to organizations
like the American Pain Foundation, an estimated 50 million
Americans suffer from chronic pain, with a cost approximating
$100 billion attributable to lost workdays, excessive or
unnecessary hospitalizations, unnecessary surgical procedures,
inappropriate medication, and patient-incurred expenses from
self-treatment. Even more important than all of this, is that
these are people in pain who are suffering.
Second, chronic pain has been historically undertreated. In
this decade, for the first time, public and medical opinion has
swung decisively in favor of active treatment of pain, in part,
based on the proven effectiveness of opioid therapy in treating
pain and the startling improvement in quality of life such
therapy can offer to patients.
In 1994, the Department of Health and Human Services issued
new guidelines encouraging the use of opioids in the treatment
of cancer pain. In February 1999, the Veterans Administration
added pain as a fifth vital sign, along with pulse,
temperature, respiration, and blood pressure, that should be
checked regularly as major indicators of health.
Congress, itself, has aggressively worked to help the cause
of recognizing pain as a vital part of modern medical
treatment. On October 28, 2000, Public Law 106-386 was enacted
declaring the decade commencing on January 1, 2001, to be the
Decade of Pain Control and Research. Bills currently pending in
both the House and Senate, The Conquering Pain Act of 2001, S.
1024, and H.R. 2156, recognize that chronic pain is a chronic
health problem affecting at least 50 million Americans. These
legislative initiatives seek long-lasting changes in public
health policy that would enable all Americans to effectively
manage medical conditions associated with chronic pain.
Mr. Chairman, we thank you for your co-sponsorship of both
H.R. 149 and H.R. 2188. Both bills advanced the cause of
effective pain management.
Third, OxyContin is widely recognized as a highly effective
treatment for pain. Its 12-hour controlled-release mechanism
affords and extended dose of pain medication, allowing patients
to sleep through the night and to avoid the sharp spikes in
blood levels of medicine that can cause side effects. Even the
most vocal critics of opioid therapy concede the value of
OxyContin in the legitimate treatment of pain. And many
patients tell their doctors and Purdue that OxyContin has given
them back their lives. Purdue is furnishing for the record
several documents that it has received from patients and their
families describing the importance of OxyContin in managing
their pain, along with a paper prepared by Pinney Associates,
Incorporated, that describes OxyContin's importance to public
health.
My company shares this committee's commitment to fighting
abuse and diversion of controlled medicines. Abuse and
diversion harm patients with pain. They harm the abusers. They
harm the cause of pain management. They harm our products and
they harm us. Importantly, abuse and diversion threaten sound
health policy, whose course should be driven by the health
needs of millions of patients, and not the crimes of diverters.
Mr. Chairman, thank you for the time you have set aside
today to discuss abuse and diversion of our product. My
colleagues and I will be happy to answer any questions.
[The prepared statement of Michael Friedman follows:]
Prepared Statement of Michael Friedman, Executive Vice President, Chief
Operating Officer, Purdue Pharma L.P.
Mr. Chairman: On behalf of Purdue Pharma L.P., the distributor of
OxyContin' tablets, thank you for taking the time to hold
this hearing. We are more distressed than anyone that this drug, which
is providing so much relief to so many people, is being abused. The
availability of OxyContin' is critical for countless
patients who are suffering from moderate to severe pain where a
continuous around-the-clock analgesic is needed for an extended period
of time. Unfortunately for those patients, concern generated by the
abuse of OxyContin' has mushroomed to the point of hysteria
in some locations, with the result that some patients are asking their
doctors to switch them to less effective drugs, some doctors are
refusing to renew patients' prescriptions for OxyContin' and
some pharmacies are no longer willing to carry OxyContin'
for their patients. Purdue receives alarming reports every day from
such physicians and patients. This hearing is important and timely.
Today's testimony bears on a significant question of health policy:
how to address the problems of abuse and diversion which accompany the
sale of a controlled drug like OxyContin' without
restricting its availability to meet the needs of doctors and patients
for the effective management of pain? This question is neither new nor
unique to OxyContin'. It has existed as long as opioid
analgesics have been available. It is a critical question, and we are
confident that Purdue has devoted more resources and efforts than has
any pharmaceutical company in attempting to answer that question.
Purdue has provided, and continues to provide, extensive assistance to
the medical and law enforcement communities in preventing and policing
abuse of OxyContin'.
While all of the voices in this debate are important, we must be
especially careful to listen to the patients who, without drugs like
OxyContin', would be left untreated. Purdue frequently hears
stories of how OxyContin' has enabled people to return to
their families and to productive lives after suffering disabling pain.
We urge you to hear directly from some of these patients at future
hearings. They are not addicts. They are not criminals. They are people
who, because of cancer, sickle cell anemia, severe back injuries, or
some other physical insult, have had their lives taken away from them
by unrelenting pain.
Amidst all the publicity and controversy, a few facts stand out.
First, the problem of chronic pain in this country is
enormous and expensive. According to organizations like the American
Pain Foundation, an estimated 50 million Americans suffer from chronic
pain, with a cost approximating $100 billion a year attributable to
lost workdays, excessive or unnecessary hospitalizations, unnecessary
surgical procedures, inappropriate medication and patient-incurred
expenses from self-treatment.
Second, chronic pain has been historically undertreated.
In this past decade, for the first time, public and medical opinion has
swung decisively in the other direction, based on the proven
effectiveness of opioid therapy in treating pain and the startling
improvement in quality of life such therapy can offer to patients.
--In 1994, the Department of Health and Human Services issued new
guidelines encouraging the use of opioids in the treatment of
cancer pain.
--In February of 1999, the Veterans Administration added pain as a
fifth vital sign (along with pulse, temperature, respiration,
and blood pressure) that should be checked regularly as major
indicators of health.
``VA officials said the change in routine is designed to call
physicians' attention to what is widely considered one of the
most unrecognized and untreated symptoms in American health
care. In a study of 10,000 dying patients published in 1995 in
the Journal of the American Medical Association, for instance,
researchers found that almost half died in severe pain; other
studies report that as many as three-quarters of advanced
cancer patients are in pain.''
Washington Post, February 1, 1999
Many other healthcare professionals and organizations have adopted
this practice of checking pain as a fifth vital sign.
--On October 28, 2000, Public Law 106-386 was enacted declaring the
decade commencing on January 1, 2001 to be the ``Decade of Pain
Control and Research.'' Bills currently pending in both the
House and Senate (The Conquering Pain Act of 2001, S. 1024 and
H.R. 2156) recognize that ``chronic pain is a chronic health
problem affecting at least 50,000,000 Americans,'' and seek
long-lasting changes that would enable all Americans to
effectively manage medical conditions associated with chronic
pain.
Third, OxyContin' is widely recognized as a
highly effective treatment for pain. Its twelve-hour controlled-release
mechanism affords an extended dose of pain medication, allowing
patients to sleep through the night and to avoid sharp spikes in blood
levels of the medicine that can cause side effects. Even the most vocal
critics of opioid therapy concede the value of OxyContin' in
the legitimate treatment of pain. And many patients tell their doctors
and Purdue that OxyContin' has given them back their lives.
Purdue is furnishing for the Record several documents that it has
received from patients and their families describing the importance of
OxyContin' in managing their pain, along with a paper
prepared by Pinney Associates, Inc. that describes
OxyContin's' importance to public health.
Purdue shares this Committee's commitment to fighting abuse and
diversion of controlled medicines. Abuse and diversion harm patients
with pain. They harm the abusers. They harm the cause of pain
management, and they harm Purdue and its products. Importantly, abuse
and diversion threaten sound health policy, whose course should be
driven by the health needs of millions of patients, not the crimes of
diverters.
1. the company: purdue pharma.
Purdue Pharma is a privately held pharmaceutical company, founded
by physicians. Purdue's headquarters are in Stamford, Connecticut.
OxyContin' is manufactured at facilities in Totowa, New
Jersey and Wilson, North Carolina.
Family ownership of Purdue and its associated companies began with
the purchase of The Purdue Frederick Company in 1952. In those early
days, Purdue's main products were Betadine' antiseptics and
Senokot' laxatives. Since the early 1980s, Purdue has
focused its research and development efforts primarily on medications
for pain management. One of the most significant advances introduced by
Purdue is the use of controlled-release opioid analgesics for the
treatment of moderate to severe pain. Controlled-release opioid
analgesics, pain medicines which last for 12 hours or more, enable
patients to sleep through the night and reduce the cycles of dosing
which provide better control of pain than drugs that require dosing
every 4 to 6 hours. Purdue introduced MS-Contin' tablets, a
controlled-release form of morphine, in 1984, and a controlled-release
oxycodone product, OxyContin' tablets, in January 1996.
Since 1984, Purdue has worked diligently to inform doctors and
other healthcare professionals about appropriate use of opioid based
medicines. This has required a significant investment, as medical
schools have traditionally spent little time teaching doctors how to
assess and treat pain or how to use our best medicines for moderate to
severe pain. For example, when Purdue started selling opioid analgesics
in 1984, many doctors were not aware that morphine could be given
orally as a treatment for pain. Today, administration of oral
controlled-release morphine is considered standard practice for the
treatment of cancer pain.
Purdue has extensively studied the use of these drugs in the
treatment of moderate to severe pain associated with various non-
malignant diseases. Often, this type of pain will only respond
adequately to opioid analgesics. Without opioid therapy, many of these
patients suffer and are disabled. Purdue's clinical research has
provided valuable experience and data to guide physicians in properly
using these medicines; for example, on determining the proper dose and
dealing with side effects.
2. the product: oxycontin' tablets.
No legal drug in the United States is more rigorously regulated
than OxyContin'. It is a Schedule II drug under the federal
Controlled Substances Act. OxyContin' is monitored by state
and federal health officials in its production, marketing, and
distribution. Both the FDA and DEA oversee OxyContin'.
The sole active ingredient in OxyContin' is oxycodone, a
synthetic opioid (narcotic) first developed in 1916. Oxycodone has been
sold in various forms in the United States for over 60 years.
Percodan', Percocet', and Tylox' are
examples of oxycodone products. Typically, but not always, these forms
of oxycodone have been combined with a co-analgesic agent such as
aspirin or acetaminophen, and they are referred to as ``combination
analgesic products''. In large doses those non-opioid analgesics may be
toxic to the liver, stomach and kidneys. Therefore, drugs containing
either aspirin or acetaminophen are limited in their usefulness because
a patient can only take up to a set amount per day to avoid aspirin or
acetaminophen toxicity. Even if a patient needs more pain relief, the
maximum dose of a combination analgesic cannot be exceeded. Purdue's
contribution was to introduce oxycodone in a timed controlled-release
form without any other active ingredients that could impose limits on
the amount a patient could take in a day.
Because of the efficacy of this single entity, controlled-released
product, doctors have found OxyContin' extremely effective
in properly managed programs of pain treatment. That effectiveness--not
abuse and diversion--led to the commercial success of the product.
3. purdue's promotion and marketing of oxycontin' tablets.
Certain media reports have been critical of Purdue's promotion of
OxyContin' tablets. The criticisms have ranged from Purdue's
provision of pain management training to doctors to the individual
promotion of OxyContin' by Purdue's sales representatives.
These reports are unfair to Purdue and squarely at odds with the facts.
Purdue's marketing efforts for OxyContin' have been
conservative by any standard. OxyContin' tablets are not
promoted to consumers. The few advertisements that appear are solely in
medical journals. Purdue is scrupulous in training its field sales
force to promote OxyContin' only for its approved
indications. Purdue managers monitor its field force for compliance
with these policies. Sales representatives are told that in the event
of a violation of our marketing policies, the offender will be subject
to discipline, up to and including termination.
Purdue does not believe that aggressive marketing played any role
whatsoever in the abuse and diversion of OxyContin'. The
physicians who were victims of ``doctor-shopping'' or prescription
fraud were hardly in this position because of our marketing. The
physicians who have been convicted of improperly prescribing
OxyContin' in exchange for cash or other inducements were
hardly motivated to do so by our marketing. And robberies from patients
with proper prescriptions were hardly encouraged by our marketing. To
the contrary, our marketing has encouraged physicians to take actions
that would reduce the abuse and diversion of OxyContin'.
Purdue has asked physicians to carefully:
--Prescribe only the quantity of product that the physician deems is
necessary based upon a complete history and physical
examination and careful assessment of the patient's pain,
--Determine that the nature and severity of the patient's pain requires
an opioid analgesic for an extended duration,
--Prescribe a quantity of medicine based upon the dosage that the
patient requires, and
--Follow up carefully with each and every patient on a regular basis.
(a) Purdue's training of its sales representatives.
Virtually all of Purdue's field force is recruited from within the
pharmaceutical industry. New sales representatives, despite their prior
experience, are enrolled in a 26 week training program, which includes
three weeks of class room training at the home office. Sales
representatives are given extensive training in the principles of
proper promotion of pharmaceutical products. They are directed to
promote only those uses of our products which are approved by the FDA
and to use only those promotional materials which are approved for use
after rigorous medical, regulatory and legal review. During this
training, representatives are told that our standard of conduct is that
during every sales call they should act as if they were accompanied by
an FDA inspector. Upon returning from their home office training, new
representatives are closely monitored by their managers who will spend
time in the field visiting doctors with them. In addition, field
trainers from the local area and the home office will often ride with
new representatives.
Moreover, in July, 2001, Purdue established a telephone ``hot
line'' to receive comments from any physician who believes a Purdue
sales representative has in any way promoted our products in an
inappropriate manner. Purdue knows of no other pharmaceutical company
that has gone to such lengths to insure that on a day-to-day basis its
sales representatives comply with the high standards that are
established during their training. The results have been reassuring;
rather than being critical, the vast majority of calls to the hot line
have complimented the professionalism of our sales representatives.
(b) Physician Education.
There is widespread consensus that medical practitioners, in the
course of their medical education, have received limited and often
inadequate training in the management of chronic pain. Physician
education has always been a principal feature of Purdue's marketing and
medical education efforts. As early as 1984 we saw that physicians
wanted and needed more information about how to assess pain in their
patients, how to determine the right dose of pain medicine, how to
treat side effects, and more recently, how to deal with the risks of
abuse and diversion. At the outset we realized that this task called
for a highly professional and highly trained field force supported by
an extensive medical education effort.
Purdue sponsors extensive training for the medical professional
community. Specifically, Purdue sponsors local lectures at hospitals
and other institutions as part of Purdue's lecture programs. These
lectures are typically attended by 40 or 50 physicians or other
healthcare professionals and deal with topics of interest to physicians
such as pain assessment, dosing, abuse and diversion, managing pain
caused by different diseases, and side effects. The lectures are often
given by experts and opinion leaders in the field of pain treatment.
They are held locally and Purdue does not pay physicians attending
these meetings for their participation.
Purdue also sponsors symposia and lectures at larger medical
meetings that are hosted by others. Purdue does not pay physicians
attending these meetings for their participation.
Until a year ago, Purdue also sponsored programs to train
experienced doctors and other healthcare professionals to serve as
lecturers to instruct other health care professionals in pain
management. These are the only trips for which Purdue provided expenses
for the travel and accommodations of physicians. It would have been
impractical to provide such training individually to participating
doctors in their home cities rather than in one central location. These
meetings were intensive working sessions that focused on issues of pain
management, and also trained and evaluated the participants in
effective speaking and communication skills.
4. what is the nature of the problem?
OxyContin' is an opioid analgesic used to treat pain.
Each tablet of OxyContin' delivers to the patient over a
period of twelve hours, a controlled-release of oxycodone. Like
morphine, OxyContin' is a Schedule II drug with recognized
abuse potential. From inception, the package insert and all promotional
material for OxyContin' has cautioned:
``TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN,
CHEWED OR CRUSHED. TAKING BROKEN, CHEWED OR CRUSHED OxyContin
TABLETS COULD LEAD TO THE RAPID RELEASE AND ABSORPTION OF A
POTENTIALLY TOXIC DOSE OF OXYCODONE.''
Since early in the year 2000 there have been a number of reports of
OxyContin' tablets being diverted and abused by drug
abusers. The patterns of abuse involve crushing the tablets to obtain
immediately the full dose of oxycodone and then ingesting, snorting or
injecting the drug. In a number of cases, there have been overdoses and
deaths. Virtually all of these reports involve people who are abusing
the medication, not patients with legitimate medical needs under the
treatment of a healthcare professional. Further, the vast majority of
those deaths involve the use of multiple medications--not oxycodone
alone.
5. what is the source of diverted oxycontin'?
According to law enforcement experts, OxyContin' and
other legitimate prescription drugs find their way into illicit
channels by means of prescription fraud, ``doctor shopping'' or other
methods of receiving inappropriate prescriptions from a doctor, theft,
diversion from Mexico, and Internet pharmacies. You have seen stories
in your local newspapers describing some of these practices.
Unfortunately, Purdue recently had an incident that we are
aggressively addressing. Purdue manufactures OxyContin tablets in two
locations. These factories operate under FDA guidelines for Good
Manufacturing Practices and are routinely inspected by the Food and
Drug Administration and the Drug Enforcement Administration. Despite a
17 year history of manufacturing controlled substances without an
incident of theft, last month Purdue discovered that two company
employees had stolen OxyContin' tablets from the production
line at its Totowa, New Jersey plant. Company officials immediately
notified local police and the DEA and terminated the employment of
these individuals, who were taken into custody by the police. Purdue as
well as the local police, DEA, and FDA are conducting further
investigations and Purdue is committed to full cooperation with these
law enforcement agencies. All internal security procedures are being
analyzed, and any weaknesses will be addressed. At this point in the
investigations, we feel it would be inappropriate to comment further.
6. how widespread is the problem?
Both Purdue and law enforcement are trying to understand the extent
of this problem. Initially, the abuse of OxyContin' tablets
was concentrated in a few parts of a few states, generally along the
spine of Appalachia, where abuse of other prescription drugs has long
been a problem due to many factors, including poverty and lack of
opportunity. In those areas the problem of the abuse of
OxyContin' is serious. The geographic scope is now broader.
Regrettably, widespread media attention may have contributed to this
wider geographic scope by calling to the attention of potential abusers
in all parts of the country that OxyContin' is a desirable
drug of abuse, along with providing detailed instructions on how to
obtain the drug and how to abuse it.
Nevertheless, it remains difficult to obtain hard evidence on the
extent of OxyContin' abuse. For example, media accounts
regularly attribute large numbers of overdose deaths to
OxyContin', even though the only toxicological evidence is
that the decedent has oxycodone in his/her blood. OxyContin'
is but one of many available products that contain oxycodone. Indeed,
OxyContin' tablets accounted for only 25% of the
prescriptions written for oxycodone products in this country in the
year 2000. Some toxicological screens of these decedents also detect
the presence of acetaminophen or aspirin, a signal that some other form
of oxycodone may have been ingested. In the vast majority of these so
called ``OxyContin deaths'', toxicological screens reflect ingestion of
a ``cocktail'' of legal and illegal drugs, and frequently alcohol as
well, in the blood of the decedent. In these cases, death is usually
attributed to the abuse of multiple drugs.
While even one death associated with the abuse of
OxyContin' is tragic, based on our preliminary analysis of
the data, it appears that the media has significantly misreported the
problem. This is most clearly shown by referring to the numbers of
deaths the press has attributed to the abuse of OxyContin'
Tablets. A few representative examples follow:
--The press indicated that Blair County, Pennsylvania was an area of
high OxyContin' abuse and that a large number of
people had died as a result. However, the County Coroner
reported to us that there were 58 deaths in the county from
January 1996 through December of 2000 and that none of them
were attributed to oxycodone alone. Of the 58 deaths, 50
involved multiple drugs. Oxycodone (although not necessarily
OxyContin') was one of the drugs found in only seven
cases, and was not listed as the cause of death in any case.
--The press has reported and repeated over two hundred times that in
Kentucky, OxyContin' caused the deaths of 59 people.
Our contacts with the State Medical Examiner and local coroners
establish that a number of deaths resulted from combinations of
illegal and legal drugs, which occasionally included oxycodone,
the active ingredient in OxyContin'. Thus far, these
local authorities have not asserted that a single death was
attributable to the abuse of OxyContin' alone.
--The press reported 35 deaths from OxyContin' use in Maine.
Similar information from the Office of the Chief Medical
Examiner showed that there were two cases where abuse of
OxyContin' was the sole cause of death, one of these
a suicide.
These statistics are provided not to minimize the tragedy of even a
single loss of life, but as examples of how the media coverage has made
it difficult to obtain an understanding of what is actually occurring.
We are gathering the facts as noted from local medical examiners and
coroners. In addition, according to the most recently available annual
data published by the US Government's Drug Abuse Warning Network
(DAWN), oxycodone in all forms, including OxyContin', was
mentioned in fewer than 1% of all prescription drug-related Emergency
Room visits in which abuse was suspected. This compares with 8.7% for
marijuana, 1.7% for hydrocodone (another opioid analgesic), and 3% for
acetaminophen.
7. could purdue have foreseen the problem?
In some 17 years of marketing MS-Contin' Tablets, a
controlled-release form of morphine--a powerful opioid analgesic
related to oxycodone--Purdue was aware of no unusual experience of
abuse or diversion. Purdue had no reason to expect otherwise with
OxyContin.' As late as January of 2000, US Attorneys Jay
McCloskey of Maine and Joe Famularo of Kentucky were advised by the DEA
that abuse of OxyContin' did not appear to be a national
problem. It was early in April of 2000 that Purdue was first alerted to
reports of abuse and diversion of OxyContin' by accounts in
Maine newspapers claiming that OxyContin' was the subject of
recreational use in Maine. Purdue immediately implemented a response
team that included some of the Company's top executives and scientists,
including those who are here today. That team has committed Purdue to
an unprecedented program to combat abuse and diversion.
8. what is purdue doing about this situation?
A long term solution to the problem of prescription drug abuse
includes the development of medicines that are inherently resistant to
such abuse. Purdue actually has been working to develop such opioid
medicines since 1996, but had originally targeted oral abuse, not
injection. In 1997, Purdue met with representatives of the DEA, NIDA,
and FDA to discuss this subject and seek information and advice. At
that meeting, Purdue presented a plan to develop a medicine containing
hydrocodone and an agent to prevent abuse by injection. Purdue was
told, however, that the principal method of abuse of hydrocodone was by
mouth, and not injection. As a result of this advice, Purdue launched
an effort to develop medicines that would be resistant to oral abuse.
This was and is a formidable undertaking as there was no existing
proven technology to achieve this goal. As a result of this effort,
Purdue developed several technologies that should enable us to achieve
the goal of having an opioid medicine that is resistant to abuse by the
oral route as well as by injection. This was recently announced in the
press.
The majority of law enforcement officials who have commented have
lauded Purdue's initiatives described below. The Attorney General of
Virginia said that as soon as Purdue learned of the problem, ``it
jumped in with both feet'' to solve it. The Attorney General of
Maryland praised Purdue's efforts and proposals and expressed concern
that adverse publicity might make it more difficult for patients in
need to obtain the product. Several United States Attorneys have
complimented Purdue for its cooperation and have requested that Purdue
bring its anti-abuse and diversion programs to their region. In several
cases the United States Attorney or his assistant has actually appeared
on such programs.
Purdue's efforts to solve the problem have included the following:
--Purdue approached and worked with FDA on labeling changes to
emphasize the abuse potential of OxyContin'. Those
changes were effected on July 18, 2001. FDA has called for
other drug companies to follow Purdue's lead in making such
changes.
--To reduce the incidence of diversion caused by physician prescribing
errors or ``scams'', Purdue has supported continuing medical
education programs of the highest quality in the areas of abuse
and diversion. These are non-promotional programs which teach
doctors how to avoid being ``scammed'' by abusers, how to
properly assess and treat patients with real pain and how to
prevent diversion.
--To encourage physicians and pharmacists to take measures to prevent
abuse and diversion, Purdue has communicated extensively on
this subject with healthcare professionals. Abuse and diversion
brochures, developed in cooperation with law enforcement
authorities, have been distributed to over 500,000 doctors and
pharmacists. These brochures have been praised by law
enforcement and welcomed by healthcare providers.
--To encourage physicians to properly assess pain and monitor the use
of these drugs in patients with pain, and avoid inappropriate
prescribing or being misled by diverters, Purdue has
distributed ``opioid documentation kits'' for years.
--To reduce the fraud that is generated by diverters altering or
copying prescriptions, in 16 states, Purdue has provided at no
cost to physicians, prescription pads utilizing special
technologies that make such alteration and copying extremely
difficult. 4667 physicians had ordered these pads as of August
17, 2001.
--To stop diversion that results from doctor shopping, Purdue has
supported the implementation of Prescription Monitoring
programs and federal government incentives to states to
encourage them to implement such programs to a federal standard
that insures accurate gathering of data, together with limited
access to the databases only by authorized law enforcement
officials and health care professional. We understand that
these programs, which would provide physicians and pharmacists
with a resource they could utilize to check up on questionable
patients, have been highly useful to physicians and law
enforcement authorities in those states where they have been
implemented to a high standard.
--Purdue has taken strong measures to prevent diversion of its product
from Mexico. We believe that these steps are unprecedented in
the pharmaceutical industry. Purdue has stopped shipping the 40
mg strength to Mexico and changed the markings on the 20 mg and
10 mg tablets sold in Mexico, so that law enforcement will be
in a position to identify tablets that are brought in from
Mexico. In addition, Purdue has made arrangements so that
OxyContin' sold in Mexico will have limited
distribution only through pharmacies that handle the most
restricted category of opioid analgesics available in Mexico.
--To better our understanding of the problem, and to participate in
solutions, some of the most senior executives from Purdue have
traveled to states where abuse and diversion have been reported
to hold briefing meetings with law enforcement officials,
including U.S. Attorneys and Attorneys General. We have also
met with the DEA, FDA and NIDA.
--Due to a paucity of reliable data on the nature and extent of the
problem of prescription drug abuse, Purdue has been working
with government and independently to develop hard data. Purdue
has assembled a team of experts to guide us in the development
of a system that will enable us to monitor abuse and diversion
and allow constructive intervention, when possible.
--As discussed above, Purdue is spending tens of millions of dollars to
research and develop new forms of strong pain relievers which
would be resistant to abuse while at the same time provide safe
and effective pain relief to legitimate patients. We are
working with the FDA to accelerate the availability of these
drugs.
9. is restricting the use of oxycontin' the solution?
Some have suggested that restricting availability of
OxyContin' will help alleviate the problem. We are convinced
this is not so. Those intimately involved with the problem agree. Local
law enforcement officers have told us that in most of the reported
cases of overdose and death, OxyContin' was neither the
first nor the sole drug abused. Knowledgeable law enforcement officers
have said that if OxyContin' were not available, those
abusing and diverting drugs would not stop their practices, but would
simply transfer to other legal and illegal drugs. We are advised by law
enforcement that in at least one area where effective measures have
reduced the availability of OxyContin', abusers and
diverters have in fact returned to their prior drugs of abuse. The only
real impact of restricting the availability of OxyContin'
tablets would be to make it more difficult for the patients who benefit
from this drug to obtain it.
10. what is the solution?
Solving the problem of drug abuse requires the cooperation of many
elements in our community: law enforcement, the schools, religious
institutions, parents and family, the courts, the medical community,
the press, federal and state legislators, government agencies, social
services providers, and the pharmaceutical industry. Purdue is trying
to help through our specific programs and our cooperation with the
other elements in the community. Prescription Monitoring Programs can
reduce doctor shopping and diversion from medical practices. Tamper
resistant prescriptions can reduce copying or alteration. Education of
responsible doctors can arm them with the tools they need to stop
diversion from their practices. A better information system can allow
us to know where abuse and diversion is cropping up and allow medical
education and law enforcement to act earlier to ``nip these problems in
the bud.'' Development of abuse resistant products can reduce the
incidence of abuse. What is needed is cooperation and common purpose.
This is a long-standing societal problem that requires a reasoned
solution.
11. conclusion.
The management of chronic pain is a critical priority of healthcare
in this country. Chronic pain affects as many as 50 million Americans
and costs the country $100 billion annually. OxyContin' has
proven itself an effective weapon in the fight against pain, returning
many patients to their families, to their work, and to their ability to
enjoy life. That advance should not be stunted or reversed because of
the illegal activities of those who divert and abuse the drug. The
answer to these problems is increased education, information and
enforcement, not restrictions that will deny patients effective
treatment of their pain.
Mr. Greenwood. Thank you very much for your testimony. We
will now hear from Dr. Michael--I have been saying Levy and
Levy. Which is it?
Mr. Levy. Levy.
Mr. Greenwood. Levy. Dr. Michael Levy, Vice Chairman of
Medical Oncology, Director of Supportive Oncology, and Director
of the Pain Management Center at the Fox Chase Cancer Center.
Mr. Levy, the floor is yours.
TESTIMONY OF MICHAEL H. LEVY
Mr. Levy. Thank you. Thank you, Chairman Greenwood, and,
Mr. Bass, for inviting me to speak at this hearing. I also am
the Director of the Pain Management Center at Fox Chase Cancer
Center, which is just about 15 minutes from here. And I think,
given the content of our discussions, I would also note that I
am the father of an 18-year-old daughter and a 21-year-old son,
and have sensitivities to all of the issues.
We see over 500 new patients in pain at our pain center
each year, and at least a third of them have pain that is not,
in fact, due to their cancer. So we see both chronic noncancer
and cancer pain in patients with a history of cancer.
I have spent the last 20 years of my career as an advocate,
both individually and in national organizations, to improve
pain management, pain assessment, organizations, such as the
American Society of Clinical Oncology, the American Medical
Association, the American Pain Society, and the American
Academy of Hospice and Palliative Medicine, of which I was
President in 1999.
We are in the midst of two epidemics, the epidemic of
unrelieved chronic pain, and the epidemic of OxyContin abuse. I
speak today on behalf of the patients with chronic pain and the
health care providers that care for them. The cure for the
current OxyContin abuse epidemic must not increase the
suffering of legitimate patients with chronic pain.
OxyContin is one of the best painkillers that we have had
available to us in the last decade. Ready access to it is
essential to our ability to provide safe and effective comfort
and function to thousands of patients throughout the country.
To summarize the more scientific content I had in my
written testimony, the cornerstone of the management of
moderate to severe chronic pain is pharmacologic management.
And we do that by an individual-tailored program of analgesic,
and what we call coanalgesic medications, to get the best
comfort and function for each patient. Optimal medical
management requires us to select the best analgesic, the right
dose, the right route of administration, the right schedule at
the right interval. We are looking as a goal of dealing with
persistent pain, of pain prevention, with then having
breakthrough medications available for episodic or intermittent
pain.
Effective pain relief requires aggressive adjustment of the
dose of the analgesic, prevention, and anticipation and
management of side effects, the utilization of specific
coanalgesic drugs based on the source of pain, and
consideration of sequential trials of opioid analgesics. Much
like hypertension medicines, arthritis medicines, each patient
has a different reaction to each analgesic, and having a
variety of them to find what is the best one to give comfort
and function, has become an increasingly important tool for us.
We have heard about the use of the Schedule II medications,
which are on the World Health Organization's Ladder 3. They are
the main medicines that we need to use in our patients who have
moderate to severe pain. These medicines include Oxycodone,
Morphine, Hydromorphone, and Fentanyl. The non-opioid
analgesics, like Tylenol or Motrin, or the combination of
Tylenol or Motrin with Codeine or Hydrocodone, have some role
in acute episodic pain, but have either dose-limiting side
effects or their own organ damage from the Tylenol and the
Motrin that is not found in the single entity Schedule II
drugs.
Morphine has been the most common Schedule II, Step 3
opioid that we have used in this country, and the standard for
pain prevention was set with MS-Contin, the controlled-release
form of Morphine, unlike OxyContin, being the controlled-
release form of Oxycodone. MS-Contin became into our hands over
17 years ago and it has been the standard for providing good
pain prevention with twice-a-day, 12-hour dosing.
We started using Oxycodone in combination products, as you
have heard other testimonies, Percocet, Percodan, and Tylox.
These agents were limited in two ways for our severe pain
patients. We couldn't give more than three Percocet without
risking a person to have liver or kidney damage with too much
Tylenol or Acetaminophen or too much aspirin and, with
Hydrocodone then, too much Ibuprofen.
Single-entity Oxycodone became available approximately 10
years ago. And we quickly found in our clinic, and the
literature supported, that there were many patients who had
less side effects, better comfort and function with Oxycodone.
But until 5 years ago, we were limited to having patients have
to take their medicines then every 4 hours.
We also found, when we were using short-acting Oxycodone,
that there was less social stigma to Oxycodone. The patients
who had been taking their Percocet or their Tylox or their
Percodan after their injury, their car accident, their
fracture, weren't as afraid of it as they were of anything that
would contain Morphine. We then were able to extend the use of
short-acting Oxycodone with the long-acting OxyContin and found
that it was effective on a twice-a-day dose. Studies showed
that it was effective for the control of pain caused by cancer,
osteoarthritis, post-herpetic neuralgia, major surgery, and
even degenerative spine disease. Studies showed that it was
comparable and preferable to short-acting Morphine and to
short-acting Oxycodone.
In combined studies, OxyContin, on a milligram-per-
milligram basis, is approximately two times as potent as MS-
Contin. I could find no data in my review of the literature, or
our clinical experience, that there was anything to say that
Oxycodone had any greater risk for addiction than Morphine,
Hydromorphone, or Fentanyl.
OxyContin has been crucial for the relief of chronic pain
because it has what we feel the characteristics of an ideal
opioid. It has a short half life, so it doesn't accumulate like
Methadone can. It has a long duration. We can give it twice a
day and get better quality of life. It has very predictable
pharmacology. That its dose relationship, its prediction, the
variation from one patient to another, is much less than most
of the other medications. It also does not have clinically
active breakdown products, which has been reported in the last
decade as being a problem with many patients who are taking
high doses of Morphine.
Its formulation also allows it to work even quicker than MS
Contin when taken appropriately, so it makes it easy to get
someone comfortable quickly. There is no ceiling, as there is--
as there was with Codeine. Studies have shown there is less
side effects, particularly hallucinations, dizziness, and
itching, and, up until now, there was minimal associated
stigma. It was much easier for us to say you have been on
Percocet. We can get you better pain relief with less danger to
your liver by using OxyContin, which is the long-acting form of
the medicine in Percocet than it would be, we need to use MS-
Contin because the public had this fear of Morphine.
The stigma has been a real issue. I think one of the
reasons that I see for the rapid rise in the appropriate use of
OxyContin is that patients and physicians have been comfortable
and know how to safely and effectively use Percocet and Tylox,
but were afraid of Morphine. So when we got a medicine that
was, okay, I know how to use Percocet. This is now the more
effective better quality of life.
Not only did we have better acceptance by our patient, but
we had better utilization by orthopedic surgeons, by
rheumatologists, by people treating very painful diseases or
procedures who traditionally would not have used Morphine, were
providing good comfort and function to these other chronic pain
patients with OxyContin.
As we have seen it in our very ill patients, because of its
better chemistry, particularly in the patients with a very
narrow window, those patients have been very--have benefited a
lot in getting less side effects, particularly nausea or
sedation.
The rapid escalating abuse of OxyContin is a double
tragedy. And we have heard from the first panel that there are
things that we don't want to happen in our society. But we also
have things that we don't want to happen in our patients after
we spent the last 20 years trying to teach them how to report
their pain, advocate for appropriate pain relief.
This first tragedy is that the disease of addiction has
found a new substance to abuse that, as has been mentioned, has
a legal, pharmacy-based, distribution system created for the
needs of appropriate chronic pain patients and the research and
patient advocacy efforts of a legitimate, FDA-approved
pharmaceutical corporation. This abuse violates the specific
instructions of the FDA-approved OxyContin package label that
states that it should only be taken orally and used for
moderate to severe pain and should not be chewed or crushed.
OxyContin abuse has increased the street value, as we have
heard, and led to violent crimes from abuse pushers--abusers,
pushers, and prescription diversion, by deviant physicians and
pharmacists. The popularity of OxyContin abuse by addicts has
also resulted in the inadvertent deaths of inexperienced drug
abusers who were not tolerant to other opioids and were not
aware of the relative potency of the different formulations of
OxyContin.
The second tragedy of OxyContin abuse is the fact that
legitimate patients are having increasing difficulties in
obtaining their appropriately prescribed OxyContin. The
extensive media coverage of OxyContin abuse has made our
patients afraid of taking their OxyContin due to resurfacing of
their concerns of addiction and tolerance that we had dealt
with appropriately with our patient education and support by
our nurses and pharmacists and doctors when they first received
their prescription. They are afraid of becoming victims of
violent crime. They are--the reduced stigma that Oxycodone
possessed has basically been destroyed.
Even when patients have their concerns about OxyContin
resolved by their health care providers, they are being
pressured by their friends, family, and uniformed health care
professionals to stop using it. My nurses and I have spent an
additional 15 to 20 minutes of patient education in the last
few months, counseling patients to just get them to use this
excellent medication. Finally, as part of the efforts to reduce
OxyContin abuse, pharmacies and prescription benefit programs
are restricting sales, making it increasingly difficult for
honest patients to obtain ready access to their appropriately
prescribed OxyContin.
Mr. Bass, you asked about remedies. State and Federal
bodies and regulatory agents much take care not to increase the
suffering of chronic pain patients by reducing access to
adequate supplies of legally prescribed OxyContin in their
efforts to control illegal OxyContin abuse.
The medical community finds itself in a very tight spot.
Heroic efforts have been spent over the last 20 years to
improve pain management, to dispel the myths of opioid
addiction and tolerance, yet study after study after study have
documented that approximately 50 percent of patients with
chronic pain are undermedicated.
Beyond the Veterans Administration process that Dr.
Friedman mentioned, the Joint Commission on Accreditation of
Healthcare Organizations found it necessary to develop new
standards for pain control to hold heath care organizations
accountable for the system-wide inadequacy. The National Cancer
Policy Board of the Institute of Medicine and the National
Research Council recently, in their June report to the
Congress, documented the persistence of unrelieved suffering in
patients with advanced cancer and made specific recommendations
to break down the barriers to excellent palliative care.
The National Comprehensive Cancer Center and the American
Cancer Society released in April Cancer Pain Treatment
Guidelines for Patients to empower them and their families to
seek out and obtain state-of-the-art cancer pain management.
These efforts have increased the public expectation of
effective pain management, as recently demonstrated in the
California case of a physician being successfully sued for
failure to relieve his patient's pain.
Just when physicians are advocating or being pressured to
provide better pain management, one of our best tools is being
threatened. We have made significant gains in our fight to
relieve pain and suffering, especially where medical science
cannot eliminate the cause of that pain. We must not let these
gains in preserving human dignity be lost.
In conclusion, interventions aimed at reducing the public
problem of OxyContin abuse must not interfere with the safe and
effective use of OxyContin for the patient problem of
unrelieved chronic pain. We must join together to halt both of
these terrible epidemics, unrelieved pain and opioid abuse. The
resolution of either of these tragedies must not intensify the
severity of the other. We must work together to heal our
society and reduce the suffering of its citizens.
I, again, thank you for this opportunity to speak and look
forward to responding to your questions.
[The prepared statement of Michael H. Levy follows:]
Prepared Statement of Michael H. Levy, Vice-Chair, Department of
Medical Oncology, Director, Supportive Oncology Program, Director, Pain
Management Center, Fox Chase Cancer Center
pharmacologic management of chronic pain
There are four basic approaches to pain control: modify the source
of pain, alter central perception of pain, modulate transmission of
pain to the central nervous system, and block transmission of pain to
the central nervous system (Jacox et al 1994, Levy 1996, Doyle et al
1997, American Pain Society 1999). Systemic pharmacologic management
aimed at the first three of these approaches is the cornerstone of the
treatment of most patients with moderate to severe pain (Jacox et al
1994, Levy 1996). Optimal pharmacologic management of pain requires
selection of the appropriate analgesic drug, prescription of the
appropriate dose, administration of the analgesic by the appropriate
route, scheduling of the appropriate dosing interval, prevention of
persistent pain and relief of breakthrough pain, aggressive titration
of the dose of the analgesic, prevention, anticipation, and management
of analgesic side effects, utilization of appropriate coanalgesic
drugs, and consideration of sequential trials of opioid analgesics
(Table 1.) (Levy 1996).
The World Health Organization created a Three-Step Analgesic Ladder
in 1990 (World Health Organization 1990). Step 1, non-opioid analgesics
such as acetaminophen and non-steroidal anti-inflammatory drugs are
limited to the treatment of mild pain due to their low maximal efficacy
and their potential for end-organ toxicity. Step 2 opioid drugs such as
codeine, and hydrocodone, and oxycodone are limited to the control of
moderate pain due to the intrinsic dose-limiting side effects of
codeine, their dose-limiting, fixed combinations with non-opioid, Step
1 analgesics, and their availability only as immediate-release
formulations. Relief of moderate to severe acute and chronic pain is
best achieved with an opioid analgesic from Step 3 of the WHO Analgesic
Ladder: morphine, oxycodone, hydromorphone, or fentanyl (Jacox et al
1994, Levy 1996, American Pain Society 1999). Morphine has been the
most commonly used Step 3 opioid analgesic for past thirty years. The
introduction of MS Contin (controlled-release morphine), twenty years
ago, set the standard for the control of chronic pain with just twice-
a-day, analgesic dosing (Hanks 1989, Thirwell et al 1989).
oxycontin: an ideal opioid analgesic
Oxycodone became extended from Step 2 to Step 3 with the
availability of single-entity immediate-release oxycodone (IRO) tablets
and liquids. Clinical studies and practical experience with these
formulations showed that oxycodone had no apparent dose ceiling, less
side effects than other opioids in individual patients, and less social
stigma than morphine (Kalso and Vaino 1990, Glare and Walsh 1993, Levy
1996). OxyContin has been available in the USA for five years and has
been shown to be effective in the control of pain caused by cancer
(Hagen and Babul 1997, Citron et al 1998), osteoarthritis (Caldwell et
al 1999, Roth et al 2000), post-herpetic neuralgia (Watson and Babul
1998), major surgery (Sunshine et al 1996), and degenerative spine
disease (Hale et al 2000). OxyContin is comparable and preferable to
IRO and is comparable to MS Contin for the control of cancer pain
(Bruera et al 1998, Kaplan et al 1998, Mucci-LoRusso et al 1998).
OxyContin is approximately twice as potent as MS Contin on a milligram
per milligram basis (Bruera et al 1998, Curtis et al 1999).
OxyContin has the characteristics of an ``ideal'' opioid analgesic
drug: short half-life, long duration of action, predictable
pharmacokinetics, absence of clinically active metabolites, rapid onset
of action, easy titration, no ceiling dose, minimal adverse effects,
and minimal associated stigma (Table 2.). Oxycodone has a serum half-
life of 3-5 hours with steady state reached in 24-36 hours (Kalso and
Vaino 1990, Glare and Walsh 1993). Double-blind studies have shown that
OxyContin given every 12 hours is as effective as an equivalent dose of
IRO given every 6 hours (Kaplan et al 1998, Hale et al 2000). OxyContin
has a biphasic absorption with a minor, initial peak at 0.6 hours and a
secondary, major peak at 6.2 hours (Kaiko et al 1996b, Mandema et al
1996, Benziger et al 1997). Clinical analgesia has an onset within 1
hour and a duration of 12 hours (Mandema et al 1996, Sunshine et al
1996). The bioavailability of oxycodone is 60-87% which increases the
predictability of its pharmacokinetics (Kalso and Vaino 1990, Kalso et
al 1991, Reder et al 1996). Clinically, the predictable
pharmacokinetics of OxyContin are demonstrated by the independence of
its dissolution on pH and the high correlation of its dose with its
plasma level (Kaiko et al 1996b, Benziger et al 1996, Kaiko 1997,
Mucci-LoRusso et al 1998, Mandema et al 1998). OxyContin's
bioavailability is increased by 15% in the elderly and approximately
50% in renal dysfunction (Kaiko et al 1996b, Kaiko 1997, Mucci-LoRusso
et al 1998, Mandema et al 1998). OxyContin has less plasma variation
than morphine (Colucci et al 1998) and has no clinically significant
active metabolites (Kaiko et al 1996a, Heiskanen et al 1998). The time-
action of oxycodone's drug effect coincides with its time-
concentration. Its drug effect is not altered by inhibition of
oxymorphone formation with quinidine (Kaiko et al 1996b, Heiskanen et
al 1998). Because of its biphasic absorption, OxyContin has an onset of
pain relief of 46 minutes, which is almost as rapid as the analgesic
onset of IRO at 41 minutes (Sunshine et al 1996, Kaiko 1997). The mean
time to peak pain relief for 40 mg of CRC is 1:29 hours compared to
2:20 hours for MS Contin (Sunshine et al 1996, Kaiko 1997). Combined
data from several controlled studies with OxyContin and MS Contin
showed that OxyContin was easily titratable and had no ceiling dose
(Kaiko et al 1996b, Heiskanen and Kalso 1997, Mucci-LoRusso et al 1998,
Bruera et al 1998, Curtis et al 1999). The average daily dosage of
OxyContin in these studies was 120 mg with an equianalgesic ratio of
morphine to oxycodone of 2:1 (Mucci-LoRusso et al 1998, Bruera et al
1998, Curtis et al 1999). Common opioid-induced adverse effects were
minimal with OxyContin and diminished over time with the same tolerance
observed with other opioids (Bruera et al 1998, Kaplan et al 1995).
Fewer patients taking OxyContin experienced severe adverse effects and
more had no adverse effects compared to patients taking MS Contin
(Mucci-LoRusso et al 1998). Patients taking OxyContin experienced less
hallucinations and dizziness (Mucci-LoRusso et al 1998, Reder et al
366, Weinstein et al 1998) or scratching and itching than those taking
MS Contin (Mucci-LoRusso et al 1998). This latter observation might be
accounted for by the speculation that oxycodone may have less
propensity to stimulate histamine liberation than morphine (Flacke et
al 1987, Poyhia et al 1992). Clinical practice has shown that oxycodone
has less associated stigma than morphine. Many healthcare providers and
patients associate morphine, but not oxycodone, with advanced illness,
impending death, and high risk of addiction (Fitzmartin and Reder
1995). In the United States, combinations of oxycodone plus
acetaminophen or aspirin have been used for years as Step 2 opioids for
moderate chronic pain and moderate to severe acute pain resulting in
greater familiarity and comfort with prescribing and taking oxycodone
than morphine (Reder and Fitzmartin 1995, Levy 1996, Caldwell et al
1999). OxyContin's freedom from acetaminophen or aspirin facilitates
upward dose titration and its 12-hour duration provides a significant
patient convenience over 4-hourly immediate-release opioids. OxyContin
has been shown to decrease pain and improve function in osteoarthritis
(Caldwell et al 1999, Roth et al 2000), post-herpetic neuralgia (Watson
and Babul 1998), major surgery (Sunshine et al 1996), and degenerative
spine disease (Hale et al 2000)
In summary, OxyContin is comparable and preferable to immediate-
release oxycodone for the control of chronic cancer pain. OxyContin is
comparable to MS Contin for the control of chronic cancer pain and is
approximately twice as potent as MS Contin on a milligram per milligram
basis. MS Contin is also effective for the control of osteoarthritis
pain, post-herpetic neuralgia, acute post-operative pain, and chronic
low back pain. OxyContin has the attributes of an ideal opioid: short
half life, long duration of action, predictable pharmacokinetics, no
clinically significant active metabolites, rapid onset of action, easy
titration, no ceiling dose, minimal adverse effects, and minimal
associated stigma (Evans 1999). Its multiple dosing forms permit its
early use and individualized titration to optimal comfort and function
in most patients with moderate to severe pain. The benefit of OxyContin
can be optimized by the use of immediate-release oxycodone for
breakthrough pain and would be greatly facilitated by wider access to
parenteral oxycodone for patients temporarily unable to use the oral
route. Its potential for less adverse side effects, relative to
morphine, might be even more advantageous for sicker patients with
narrow therapeutic windows for opioid analgesics.
oxycontin abuse: a double tragedy
The rapidly escalating abuse of OxyContin in the last year is a
double tragedy. The first tragedy is the fact that individuals with the
disease of addiction have found a new substance to abuse that has a
legal, pharmacy-based, distribution system created by the needs of
appropriate chronic pain patients and the research and patient advocacy
efforts of a legitimate, FDA-approved pharmaceutical corporation.
OxyContin abuse by these individuals has led to violent crimes by these
individuals and to prescription diversion by deviant physicians and
pharmacists to profit from OxyContin's increased street value. The
popularity of OxyContin abuse by addicts has also resulted in the in
the inadvertent deaths of first time drug abusers who were not tolerant
to opioids and were not aware of the relative potency of the different
formulations of OxyContin available.
The second tragedy of OxyContin abuse is the fact that legitimate
pain patients are having increasing difficulty utilizing their
appropriately prescribed OxyContin. The extensive media coverage of
OxyContin abuse has made patients afraid of taking their OxyContin due
to resurfacing of their concerns of addiction and tolerance that had
been accurately addressed by their physicians and nurses when they
received their first prescription. Patients are also afraid of being
victims of violent crime by addicts or dealers who want their
prescriptions or their OxyContin pills. The reduced stigma that
oxycodone once possessed compared to morphine has decayed. Even when
patients have their concerns about using OxyContin resolved by their
health care providers, they are being pressured by their friends,
family, and uninformed, health care professionals to stop using it.
Finally, as part of their efforts to reduce OxyContin abuse, pharmacies
and prescription benefit programs are restricting OxyContin sales,
making it increasingly difficult for honest patients to obtain ready
access to their appropriately prescribed, OxyContin.
remedies for oxycontin abuse must not interfere with relief of chronic
pain
Regulatory agencies such as the FDA and DEA must take care not to
increase the suffering of chronic pain patients by reducing access to
adequate supplies of legally prescribed OxyContin in their efforts to
control illegal OxyContin abuse. Despite heroic efforts over the past
twenty years by individual and organizations to redress the balance of
medicine and ensure appropriate assessment and treatment of chronic
pain, surveys still show that half of the patients in this country with
chronic pain are undertreated. Last year, the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO) found it necessary to
develop new standards for pain control to address this system-wide
inadequacy. The National Cancer Policy Board of the Institute of
Medicine and the National Research Council recently underscored the
persistence of unrelieved suffering in patients with advanced cancer
and made specific recommendations to break down the barriers to
excellent palliative care (Foley and Gelband, 2001). The National
Comprehensive Cancer Network and the American Cancer Society have just
released Cancer Pain Treatment Guidelines for Patients to empower
patients and their families to seek out and obtain state-of-the-art
cancer pain management. As an example of the increasing public
expectation of effective pain management, a California physician was
just successfully sued for failure to relieve his patient's chronic
pain. Interventions aimed at reducing the public problem of OxyContin
abuse must not interfere with the safe and effective use of OxyContin
for the patient problem of unrelieved chronic pain.
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Mr. Greenwood. Thank you, Dr. Levy, for your excellent
testimony, and we appreciate that. And, finally, Nurse Terry
Atwood. Thank you for being with us.
Ms. Atwood. Thank you.
Mr. Greenwood. And don't be intimidated by these
microphones in your face.
Ms. Atwood. Sure.
TESTIMONY OF THERESA ATWOOD
Ms. Atwood. My name is Theresa Atwood. In the recent past,
I have practiced nursing in Philadelphia, Bucks, and Delaware
Counties, and I am a resident of Delaware County. I am a
Registered Nurse, certified by the American Nurses'
Credentialing Center in the specialty of Psychiatric and Mental
Health Nursing. I hold a Master of Human Services Degree and am
a member of the American Psychiatric Nurses' Association, as
well as the American Counseling Association.
As a mental health/addictions professions, a family member
of people who suffer from, or are in recovery from the disease
of addiction, and as a person who is also in recovery from this
disease, I have continuous exposure to it, in its many forms,
and in its various stages of progress and outcomes. I am
grateful you have granted me the honor of speaking here today.
In considering the escalation of the number of people
becoming addicted to, and dying from, the misuse of OxyContin,
it is important to realize that its respiratory depressant
effects can be lethal with any, including the initial use, that
is not monitored by a physician. The likelihood of death is
increased because when used in conjunction with alcohol and
other sedatives, as is the practice among many teenagers, the
respiratory-depressant effects are potentiated. The rapid
increase in the number of young people able to access and
consequently abuse OxyContin is intensely apparent in my daily
practice.
Many, if not most, of the adolescents I come in contact
with are well aware of how ``good'' the ``Oxy's'' are. When I
ask my young patients if they realize that OxyContin is just
as, if not more, deadly than heroin, they respond with great
skepticism and apathy because they view OxyContin as a
medicine, not a street drug, making it more attractive to a
wider variety of teens. These young people consider OxyContin
to be a cleaner, prettier, more powerful form of heroin.
Although they are vastly informed of the positive euphoric
potency of OxyContin, they have little, if any, information
about its often fatal respiratory depressant and other side
effects, and the eventual withdrawal syndrome. This lack of
knowledge and lack of concern for their own existence is
evident as the freely admit to, and even brag about,
supplementing OxyContin use with alcohol and other opioids, a
practice that has proven to have detrimental consequences.
Upon entering treatment, often as a result of legal or
familial force, adolescents are resistant to intervention or
education. This opposition is not only a result of their
inherent developmental ideology of independence, omnipotence,
and immortality, but also because OxyContin provides the
ultimate in escapism. I have watched young people walk out of
treatment centers, risking imprisonment, homelessness, the loss
of families, including the loss of their own small children,
and even the loss of their own lives, rather than face the
prospect of life without OxyContin and other drugs.
The horrible dilemma of OxyContin misuse recently hit home
for me. My relative had been in a car accident, suffered spinal
trauma, and was being treated with Percocet for a number of
years. As his tolerance to the Percocet increased, his
physician began to utilize OxyContin to manage his back pain.
Once he was introduced to OxyContin, he required more and more
of it. He was initially prescribed 10 milligrams, then 20, then
40, 80, and finally 160 milligrams. At the conclusion of his
active use, he was taking up to four 160-milligram OxyContins,
with Percocet, Soma, and Fioricet, a day, an amount which, by
all accounts, could have easily been fatal.
He states that once addicted, he began chewing the
OxyContins, despite the accompanying nausea and gagging. He
tells me that as he would be picking up a prescription, his
mind would be racing to figure out a way to get the next one.
He offered many excuses to physicians, such as his son spilled
the pills down the sink, or his car was robbed. He admits to
loss of libido, lack of motivation, outside of obtaining the
pills, and wide mood swings. He says, I didn't want sex. I had
no feelings. All that I thought about was getting the next
script.
After many months, his wife began threatening to leave him
and his performance and relationships at work began to suffer.
This didn't happen when I practiced. He knew he needed to stop
using the medications, and he states he really wanted to, but
despite all thoughts, desires, and actions to the contrary, he
continued and increased his use. He tells me, as I sat there
watching everything I had ever wanted, my wife and family,
packing up and walking out the door, I literally couldn't even
move to stop it. I was so screwed up.
Currently, my family member has 96 days cleans and he just
got a promotion at work, but he adds, my wife is still gone.
After long-term treatment experience, he was able to obtain
recovery thus far. Maintaining his recovery is difficult and
requires much outside support. He now uses a non-narcotic
prescription medication to manage his back pain, which he
assures me works well, however, his insurance won't pay for it.
Ironically, they paid over $100,000 for the OxyContin he took.
Obviously, there is a blaring need for quality treatment for
those who become addicted to this medication.
To summarize, those patients for whom it is truly
indicated, OxyContin is absolutely beneficial and necessary,
however, for those who recreationally use it, or become
addicted, it is just as powerfully destructive. Thank you all
for your time and attention, and I implore you to ask me any
questions you may have.
[The prepared statement of Theresa Atwood follows:]
Prepared Statement of Theresa Attwood, Registered Nurse
My name is Theresa Attwood. I am a registered nurse, certified by
the American Nurses' Credentialing Center in the specialty of
Psychiatric and Mental Health Nursing. I hold a Master of Human
Services Degree and am a member of the American Psychiatric Nurses
Association as well as the American Counseling Association. As a mental
health/ addictions professional, a family member of people who suffer
from, or are in recovery from the disease of addiction and as a person
who is also in recovery from this disease, I have continuous exposure
to it in it's many forms and in its various stages of progress and
outcomes. I am grateful you have granted me the honor of testifying
here today.
In considering the escalation of the number of people becoming
addicted to, and dying from, the misuse of OxyContin, it is important
to realize that its respiratory-depressant effects can be lethal with
any, including the initial use, that is not monitored by a physician.
The likelihood of death is increased because when used in conjunction
with alcohol and other sedatives, as is the practice among many
teenagers, the respiratory-depressant effects are potentiated. The
rapid increase in the number of young people able to access and
consequently abuse OxyContin is intensely apparent in my daily
practice.
Many, if not most, of the adolescents I come in contact with are
well aware of how ``good'' ``Oxys'' are. When I ask my young patients
if they realize that OxyContin is just as, if not more, deadly than
heroin, they respond with great skepticism and apathy because they view
OxyContin as a medicine--not a street drug, making it more attractive
to a wider variety of teens. These young people consider OxyContin to
be a cleaner, prettier, more powerful form of heroin. Although they are
vastly informed of the positive euphoric potency of OxyContin, they
have little, if any, information about it's often fatal respiratory
depressant effects and the eventual withdrawal syndrome. This lack of
knowledge, and lack of concern for their own existence, is evident as
they freely admit to, even brag about, supplementing OxyContin use with
alcohol and other opioids--a practice that has proven to have
detrimental consequences. Upon entering treatment, often as a result of
legal or familial force, adolescents are resistant to intervention or
education. This opposition is not only a result of their inherent
developmental ideology of independence, omnipotence, and immortality,
but also because OxyContin provides the ultimate in escapism. I have
watched young people walk out of treatment centers, risking
imprisonment, homelessness, the loss of families--including the loss of
their own small children, and even the loss of their own lives, rather
than face the prospect of life without OxyContin and other drugs.
The horrible dilemma of OxyContin misuse recently hit home for me.
My relative had been in a car accident, suffered spinal trauma, and was
being treated with percocet for a number of years. As his tolerance to
the percocet increased, his physician began to utilize OxyContin to
manage his back pain. Once he was introduced to the OxyContin, he
required more and more of it. He was initially prescribed 10 mg, then
20, then 40, 80, and finally 160 mg. At the conclusion of his active
use, he was taking up to four 160mg OxyContins, with percocet, soma and
fiorecet, a day--an amount which, by all accounts, could have easily
been fatal. He states that once addicted, he began chewing the
OxyContins, despite the accompanying nausea and gagging. He tells me
that as he'd be picking up a prescription, his mind would be racing to
figure out a way to get the next one. He offered many excuses to
physicians, such as: his son spilled the pills down the sink or his car
was robbed. He admits to loss of libido, lack of motivation (outside of
obtaining pills) and wide mood swings. He says, ``I didn't want sex, I
had no feelings, all that I thought about was getting the next
script.'' After many months, his wife began threatening to leave him
and his performance and relationships at work began to suffer. He knew
he needed to stop using the medications, and he states he really wanted
to, but despite all thoughts, desires and actions to the contrary, he
continued and increased his use. He tells me, ``As I sat there watching
everything I had ever wanted, my wife and family, packing up and
walking out the door, I literally couldn't even move to stop it--I was
so screwed up.'' Currently, my family member has 96 days clean and he
just got a promotion at work, but he adds, ``my wife's still gone''. He
now uses a non-narcotic prescription medication to manage his back
pain, which he assures me works well, however, his insurance won't pay
for it--ironically, they had paid over $100,000 for the OxyContin.
To summarize, to those patients for whom it is truly indicated,
OxyContin is absolutely beneficial and necessary, however, for those
who recreationally use it, or become addicted, it is just as powerfully
destructive.
Thank you for your time and attention.
Mr. Greenwood. Thank you very much for your testimony. It
never happens when you practice it. It gets real here. Thank
you very much. Dr. Friedman, let me begin with you. Is it Dr.
Friedman?
Mr. Friedman. It is Mr. Friedman. Thank you.
Mr. Greenwood. Look, we stipulate, I stipulate, yours is a
good company with a long and exemplary record in, as I said, in
my opening statement, relieving pain. And I believe that your
product and your company has done, by orders of magnitude, more
to relieve pain in this country than to cause it. There is no
question about that. It is also clear that, as the last witness
indicated, it has caused a lot of pain, as well.
When you have a--it seems to me that when you have a
product that is this powerful, and that is what this drug is,
this is a powerful drug--there are a couple of things that you
want to do. You want to make sure, as hard as you can, that it
gets into the hands of people who are suffering. And you try--
and you do that very aggressively. It seems to me, equally as
obvious, that you have to do all that you can in making an
equal effort to make sure that this drug is not abused to the
extent that you can. And it doesn't cause anguish, because the
anguish of the families sitting here to our right will go on
forever over the loss of their young son.
It is clear that your company did an extraordinary job in
the first case. Marketing was aggressive, even aggressive by
today's market expandance. Make sure that you research the
markets. You had an aggressive sales force. You have got
seminars that you put on and so forth.
The question is--and you are not on trial here. The
question is, has the company done enough to prevent the
misdirection--you knew going into it--you had to know going
into it that this is a product that is likely to be diverted to
the street, it is likely to become addictive, it is likely to
be stolen, it is likely to become lethal when used not
according to directions.
So I guess the questions that I have for you are, what have
you done along those lines and have your efforts been--you have
$1.25 billion in sales a year, if my numbers are correct, 83
percent of your revenue as a result of your very aggressive
marketing. How aggressive have you been in the other half of
your responsibility, and that is, to protect the public from
the negative consequences of this product? And how might we be
of assistance to you with regard to this product and other
products in creating tools for law enforcement, tools for the
monitoring of these products, education efforts? Tell us how we
can be not just accusers here, but how we can be part of the
solution?
Mr. Friedman. Mr. Chairman, thank you. Purdue would like to
take a lead role in helping to solve this problem. And we have
worked diligently, as long as we have been marketing narcotic
analgesics, to market them responsibly. When we launched MS-
Contin in 1984, that product required a great deal of
education, because up until that time, many physicians,
including oncologists, did not see the importance of the need
to control pain. When we made visits to oncologists back then,
we were told, at times, our job is to cure the cancer. Pain is
not the focus of our practice.
But since 1984, we have seen a see change in medical
thinking. But all through that time, that see change took place
as a result of a great deal of education. We knew that in order
to use these products properly and responsibly, physicians
would need education. They would need information and they
would need tools. And we have sought, through that entire
period, to provide those tools.
As we marketed MS-Contin, up to the launch of OxyContin in
1995, the end of 1995, we saw very little evidence of abuse and
diversion of MS-Contin. When we launched OxyContin, we saw very
little evidence of abuse and diversion until some time around
2000, which, based on the testimony I have heard from other
panelists, is the time that, in general, that type of abuse and
diversion was noticed.
But we are doing much more than our medical education and
other programs. We have been working very hard to develop
products that would be resistant to abuse and diversion, as
well, which we think is an important long-term solution.
Mr. Greenwood. I addressed some questions to the
representative of the Drug Enforcement Agency about data that
is available. In informal conversations with representatives of
your company, I have been led to understand that there is a
private entity that creates a data base that I thought provided
the data in terms of prescriptions per physician, and that your
company, in fact, acquires that data on an ongoing basis and
has that data. Can you summarize that for us? What does your
company know about how many prescriptions each physician writes
for your OxyContin?
Mr. Friedman. We do acquire data very much along the lines
that you describe, Mr. Chairman. We acquire it from IMS Health.
IMS Health captures this data through the computers at
pharmacies. Of course, certain patient information is excluded
to protect the patient's right to privacy.
Mr. Greenwood. Like, for instance, if Dr. Paolino here in
Buckingham--Bensalem, wrote 1,200 prescriptions in the 5-month
period, that is data that you would have had. Correct?
Mr. Friedman. Correct.
Mr. Greenwood. Okay. Now, when you have that data, I would
guess that one of the things that you would do with that data
is arrange it so that you can take a look at--you can rank
these physicians. You have some indication as to who is writing
the most, who is writing the least, and in between, and who the
outliers are. Do you have--do you look at that information in
that way?
Mr. Friedman. Yes. The only comment that I would add is
that we get the data somewhat after the actual event of the
prescription. There is a 6 to 8-week lag.
Mr. Greenwood. Okay. But assuming that Dr. Paolino was a
great outlier, very abusive individual, who wrote this without
any regard whatsoever for the medical condition of the
patients, wrote these prescriptions as fast as he could purely
for profit-making purposes. What does your--I would think that
Dr. Paolino--I would hope that he would have stuck out like a
sore thumb and that there must be other Dr. Paolinos in this
country who do the same--take the same kind of approach, and
that that information would be aware--that your company would
be aware of that kind of information. The question then is, how
do you respond to that, when you see a doctor who is not
associated with Fox Chase Cancer Center, and is just a little
osteopath here in Bensalem, doing this vast number? What do you
do with that information?
Mr. Friedman. Well, we have learned over the years that the
absolute number of prescriptions that a physician is
prescribing is, in and of itself, not an indicator of the
doctor doing something wrong. We don't measure or assess how
well a physician practices medicine. We are not in the office
with a physician and a patient observing the examination or
involved in that process. We know, for example----
Mr. Greenwood. Well, why do you want that information then?
Mr. Friedman. Well, we use that information to understand
what is happening in terms of the development of use of our
product in any area.
Mr. Greenwood. And so the use of it--and I assume that part
of it--a large part of it you want is to see how successful
your marketing techniques are so that you can expend money in a
particular region or among a particular group of physicians--
you look to see if your marketing practices are increased in
sales. And, if not, you go back to the drawing board with your
marketers and say, how come we spent ``X'' number of dollars,
according to these physicians, and sales haven't responded. You
do that kind of thing. Right?
Mr. Friedman. Sure.
Mr. Greenwood. Okay. So it would seem to me that you would
also have a responsibility--see, this is what I am getting out
of my first question. You took all that data and you looked at
it for the first part, to see how you were doing in the first
part of your responsibility--get the product out, increase
sales, increase revenues. Okay. Did you look at the data with
a--in response to your last question, you said we don't look to
see how physicians are practicing medicine. Well, that is the
other side of your responsibility. Why wouldn't you have been
using this data to make sure that the Dr. Paolinos of the world
weren't wrecking the reputation of your product?
Mr. Friedman. I think Mr. Udell might be able to respond to
that more further.
Mr. Udell. One of the----
Mr. Greenwood. Well, perhaps he can pull up a chair and
speak into the microphone, Mr. Udell. Maybe I can stand here.
There isn't a chair. Mr. Chairman, one of the things----
Mr. Greenwood. Well, you need to talk into this microphone
here.
Mr. Udell. Thank you, Mr. Chairman. One of the things that
we learned when we visited with law enforcement around the
country when this problem first arose, was what Mr. Friedman
said, that drug enforcement people tell us that you can't look
at prescriptions alone. You have to look at what the doctor is
actually doing in the office. And apparently that happened
here. But that is not something----
Mr. Greenwood. Well, you didn't do it.
Mr. Udell. That happened here in terms of law enforcement.
Mr. Greenwood. Well, and local pharmacists saw----
Mr. Udell. Correct.
Mr. Greenwood. He had rough data----
Mr. Udell. Right.
Mr. Greenwood. [continuing] that you had. And he saw, from
his perspective--he looked at this data and he said, Holy God,
there is some guy in Bensalem----
Mr. Udell. That is right.
Mr. Greenwood. [continuing] called Paolino and he is
writing prescriptions out the wazoo.
Mr. Udell. Yes.
Mr. Greenwood. Now, he had that data and he blew the
whistle.
Mr. Udell. Correct.
Mr. Greenwood. And you had that data. What did you do?
Mr. Udell. Well, we didn't have the data that he had. We
didn't know that you had a physician a distance away writing
prescriptions that were filled in a particular pharmacy. I
think that that is what alerted that pharmacy, at least as I
understand the reports in the paper.
What I am trying to say is that our sales representatives
have a couple of minutes with a doctor. They talk to the doctor
about the product and they leave. Law enforcement tells us that
high numbers, high numbers of prescriptions, may or may not be
a signal. They may not be, even if he is not at Fox Chase, even
if he is a rural physician. It is not necessarily a signal.
What they have to do is, they have to get in there and try to
find out. It is a very difficult task. They have explained to
me again and again, that trained investigators--and you heard
from Mr. Demarest earlier, and he is one of those kinds of
investigators--trained investigators can go in there and try to
assess these things.
Mr. Greenwood. Let me interrupt you.
Mr. Udell. Our people just don't have the----
Mr. Greenwood. Let me interrupt you for a second. And I
don't want to be too harsh here. But, look, the law enforcement
people have a million things to do.
Mr. Udell. Yes.
Mr. Greenwood. And they are not getting $1.25 billion a
year to do it. They are all stretched, in terms of time,
manpower, and budget. Okay.
Mr. Udell. Yes.
Mr. Greenwood. It seems to me that your company has a
responsibility to be looking at this data and not relying on
what law enforcement tells you, but saying what does Purdue
Pharma have as a responsibility to do with the data that we
have that tells how many doctors are selling--which doctors are
writing how many prescriptions----
Mr. Udell. Yes.
Mr. Greenwood. [continuing] and how do we make sure that
those are all good prescriptions, and weed out the bad actors?
It is in your interest to do that.
Mr. Udell. Yes.
Mr. Greenwood. And I don't understand why that hasn't been
something that you have been aggressively doing.
Mr. Udell. It is absolutely in our interest to do so. And I
think that we have all learned a lot from the case of Dr.
Paolino. If we are to--the story, the picture that is painted
in the newspaper is of a horrible, bad actor, someone who has
preyed on this community, who has caused untold suffering. And
he fooled us all. He fooled law enforcement. He fooled the DEA.
He fooled local law enforcement. He fooled us. None of us,
until a certain point in time, had an understanding that
something wrong was going on there. And I think that we all
have to learn from that. I think you are absolutely correct. We
have to learn from this experience and we have to examine
ourselves, is there more that we can do? Is there more that DEA
can do? Is there more that local law enforcement can do? Is
there more that we can do?
Now, we are examining that. We have spoken to the sales
representative who called on this doctor. And there came a
point in time when she was alerted--she was alerted by a----
Mr. Greenwood. But if I can interrupt you, we have had this
conversation before. And it seems to me part of the problem is
that your sales force gets paid on a commission basis, and the
more they sell, the better they do.
Mr. Udell. Yes.
Mr. Greenwood. So it is awfully hard to imagine that they
would be the people in your organization who would go out and
tell the doctors you are making me too much money. You are
writing----
Mr. Udell. We would----
Mr. Greenwood. You are writing too many prescriptions.
Mr. Udell. Mr. Chairman, I don't know how clearly I can put
this. Our sales force understands that the survival of the
company, the product, and their livelihood, depends on them
doing the right thing and making sure that the doctors who
write these prescriptions write them properly. They understand
that that is job No. 1.
In areas where we have seen abuse and diversion, and as I
spoke with staff and discussed with staff earlier, in areas
where we anticipated that there might be abuse and diversion,
we have tried to get out in front of the problem. And Mr.
Friedman has talked to his sales people and he has said to
them, your job is not to sell OxyContin. Your job is to go in
there and try to be a part of the solution and to say to these
doctors, you must write these prescriptions correctly. You must
keep appropriate records. You must comply with State Medical
Board regulations and DEA regulations. We have tools. We have
devices. We have techniques to help you do so. And if you are
not prepared to do so, do not write our product. Please, do not
write our product.
So while it is correct that there is a--there may be an
incentive to extol the virtues of the product, there is clearly
a greater incentive to make sure that the product is not
written inappropriately. Dr. Paolino has done more to harm the
company and the product than perhaps anyone in the country.
There is no reason why we would want to do anything to support
those kinds of activities or encourage them or countenance
them, if we are capable of stopping it.
Mr. Greenwood. I am going to yield now--if there is another
Dr. Paolino in the country or 10 of them, there is--my guess is
that there are--some of them are going to emerge, and I hope
that you would take the step to prevent that. The Chair yields
to the gentleman from New Hampshire to inquire.
Mr. Bass. Thank you very much, Mr. Chairman. Sir, I think
you might as well remain up there. What is your name again? I
am sorry.
Mr. Udell. Howard Udell.
Mr. Bass. Mr.--Attorney Udell, what exactly are you doing
today, tomorrow, or next week, to prevent incidents like the
one just discussed----
Mr. Udell. Yes.
Mr. Bass. [continuing] from ever happening again?
Mr. Udell. Yes. Well, perhaps Michael--perhaps, you would
want to talk about the program.
Mr. Bass. Without--but, be specific, please.
Mr. Udell. Yes. Sure.
Mr. Bass. You have the data. You know that 1,200
prescriptions in 5 months is not the norm. Perhaps, you may not
have noticed it because you weren't expecting it. What are you
doing now to assure that your product is not abused in any--in
this manner ever again?
Mr. Friedman. Well, if I could comment briefly? When this
problem first cropped up, it was a surprise to many. And when
we heard about the problem, we first had to go learn more about
it. And personally, I have traveled to visit the Attorneys
General in 10 States where the problem seemed to be most
prevalent. I have met with--when the problem was first
identified with U.S. Attorney McCloskey in Maine and U.S.
Attorney Crouch in Virginia, at those meetings, they helped us
to understand the problem and helped us define things we could
do that were beyond the things we were doing at that time.
We also learned the nature of the problem. Because the
first question that I asked was, where is this coming from?
What is the source of this diverted drug? And what we were
told, at the time, and what seems to be the prevalent thinking
today, is that the first source is some kind of prescription
fraud, copied prescriptions, altered prescriptions, stolen
prescriptions. A second type of problem is some kind of
fraudulent prescribing or error in prescribing. And we tried to
set up programs working with law enforcement that would address
those specific things. So, for example, we developed a program
and a campaign to provide physicians with tamper-resistant
prescriptions.
But one of the other things we recognized that we needed,
and others needed, was information. In order to identify a Dr.
Paolino, or some other person abusing--you know, writing drugs
that was creating a pattern of abuse, we needed a system for
figuring that out. We didn't know how to identify abuse.
And so what we did was, we, first of all, looked at the
available data sources. But since that time, what we have done
is we have convened a panel of experts to help us design a
data-gathering system, an information system, and a warning
network for ourselves. Because absent such a system existing,
we need some way of reaching out and understanding where is
abuse going on. Because we have learned that the number of
prescriptions is not indicative, in and of itself, of abuse. We
need to know more. And these experts are helping us develop
such a system so that we can identify the places where abuse
and diversion is going on and design some kinds of
interventions.
Mr. Bass. Okay. Tell me, Mr. Friedman, that you consider
this issue to be a crisis for your company. You have got $1.27
billion apparently in revenues. You have the resources to be
very aggressive, and you have the interest to do it, as well.
And understanding the nature of the problem, developing
information, and establishing a panel to study it, and to try
to understand it. The mysteries of it are certainly
commendable. But those things ought to be done in a matter of
weeks, not months or years. You ought to have--and it is none
of my business--but you ought to have an office within your
organization that is responsible for internal investigations
and develop relationships with law enforcement community,
because it isn't in your best interest to have these people
writing all these prescriptions like this.
And, frankly, I am not impressed with panels and study
problems, and calling people on the telephone to try to figure
it out. You have access to the data already. Now, I mean, that
seems to be obvious to me. But there are other things that you
could do. And I wanted to know if I could ask--first of all, I
would love it if you would tell me that you are going to be
more aggressive in establishing panels and trying to understand
the issue better--that you are really going to do something to
solve it, that is substantive, quick, and effective.
Second, let me ask you, are there other things that the
company might consider doing, for example, restricting the
distribution of this drug to certain physicians and certain
pharmacies that are really qualified to dispense this
prescription?
Third, adding substances to the drug that would make it
impossible or reduce its toxicity if it were crushed or taken
in other--in an adverse manner?
Mr. Friedman. Well, first of all, I would like to say that
I can tell you that we will be more aggressive and we will do
as much as we can to solve the problem.
Mr. Bass. Can you keep the subcommittee informed as to that
progress?
Mr. Friedman. Yes, sir.
Mr. Bass. Thank you.
Mr. Friedman. And insofar as the question of what we can do
about a new--adding substances or making abuse-resistant
formulations, I might ask Dr. Goldenheim to provide some
comments.
Mr. Bass. Before he does, can you address the third issue,
which is the restriction of sales to people who are really
outside a general practice or to any--that issue?
Mr. Friedman. Yes.
Mr. Bass. I can't think of any other ways to deal with the
issue.
Mr. Udell. Restricting sales has been described to us in
two ways. One is restricting the types of doctors who would use
these drugs, and the second is restricting certain--
distribution to certain pharmacies. I think, Mr. Bass, you
alluded to both of those.
Mr. Bass. Yes.
Mr. Udell. With respect to the first, it is a terribly
difficult problem. We understand that there are about 4,000
pain specialists in the United States. There are vast numbers
of patients who need drugs, such as OxyContin, who don't have
access to those doctors. Now, what happens, even in the case of
cancer patients, who are at the prestigious institutions,
cancer centers, when they go back home into the community,
their pain is managed by their family physician. So it is very
difficult to say you are going to restrict access only to
specialists, because to do so would be to deprive the vast
majority of people who need it, of these drugs.
On the other hand, DEA has said, and we totally agree with
DEA on this, is that physicians should not use drugs like this
unless they know how to use them. Whether they are pain
specialists, or whether they are family physicians, they should
know how to use them. And the other is a role for us, and it is
a role that we undertake willingly and happily, and that is, to
try to help these doctors understand how to use these drugs.
And the programs that Mr. Greenwood spoke about, programs
that we have put on, to teach doctors how to use these drugs
responsibly and appropriately, have been invaluable. And they
have been directly applicable to solving the problem.
For example, in the State of Kentucky, when the United
States Attorney, Mr. Famularo--I saw him on television and he
had made an arrest of 200-plus people involved in drug trade--
prescription drug trade. I called him in the morning, the very
next morning, and I said to him, we distribute OxyContin.
OxyContin played a major role in the large drug bust that I
read about yesterday. We want to help be a part of the problem.
How can we help you? And we start--we embarked on a
conversation of what we can do to help that problem in
Kentucky. And what was very important to him is this very
subject--education. He said we have a lot of doctors who don't
understand how to use these drugs. They need education. Can you
help us with that? And we did.
We established a group, together with the United States
Attorney's Office. He designated an Assistant United States
Attorney to work with us, and together, we put on programs in
the community where there was the greatest abuse, to try to
deal with the problem. And Mr. Famularo, himself, attended
those programs.
Even earlier, when we first heard of this problem, the very
earliest time--it was very interesting that Mr. Woodworth said
that he knew about it earlier than this and he assumed that we
did. And that was a surprise to me because Mr. McCloskey, who
was the United States Attorney in Maine at the time, told me
that when he started to see that problem, at the very earliest,
at the beginning of 2000, he reached out to the DEA for
information and the DEA people with whom he spoke said, they
don't know of an OxyContin problem. They are unaware of an
OxyContin problem.
And that brings us right to the point that was made by the
District Attorney of Bucks County. I think that she made a
wonderful point. Cooperation and sharing of information is
essential. And if some element in the DEA knew there was a
problem, Mr. McCloskey should have known about it. He is the
United States Attorney. He should have gotten an affirmative
response. We should have known about it. And we didn't know
about it. And we didn't know about it. We knew about it after
it pulsed up in Maine and the press reported it. And, again,
the first thing we did was we said, we want to go up and see
you. We want to meet with you, and we did. And we met with Mr.
McCloskey.
And, again, Mr. Bass, in answer to your specific question,
we acted very quickly. At that meeting, we said to Mr.
McCloskey, we want to work together with you to solve the
problem in Washington County, Maine. How can we do it? And what
we--and what came out of that meeting was, we said to him, we
call on all the doctors in this community, the doctors who
write these prescriptions. We can deliver a message to these
doctors. And, frankly, the message that we want to deliver is
the same message that you want to deliver. And that is, these
drugs can be prescribed and dispensed responsibly or not, and
we want them to be dispensed and prescribed responsibly.
We can deliver the message. And we said to Mr. McCloskey,
let us work together to develop a message, to develop a program
for these doctors. And we did. We developed a brochure,
together with Mr. McCloskey. Immediately, at that meeting, we
said, let us start to work our people and your people and
develop a method of communicating with doctors in this
community, which is ravaged by abuse of our product, to try to
solve it. And that meeting, and those discussions, resulted in
very effective tools, which have been praised by law
enforcement throughout the country.
Now, Mr. McCloskey told us that, at that meeting, he
realized that there were certain resources that law enforcement
has and there are certain resources that law enforcement does
not have. And he realized, then and there, something that you
have heard throughout this hearing--and I think it is a very
significant thing--and that is, we have to all work together.
We are willing. We are eager. We want to do our part.
Mr. McCloskey said that he realized, at the meeting with
us, that Purdue had resources and skills that law enforcement
didn't have. And the objective is to pull these together and
fight the problem. We are here. We have traveled all over the
country. Mr. Friedman and I have personally visited--these are
not phone calls--we have personally visited with law
enforcement people across the country where this is a problem,
and we have asked one question. Describe your problem to me and
tell us how we can help to solve the problem. We are very
sincere on this, Mr. Bass.
Mr. Bass. Is Dr. Haddox here or is he----
Mr. Udell. No. He is not.
Mr. Bass. He is quoted as saying--and this is the other
issue--that Purdue has been working to reformulate OxyContin.
Mr. Udell. Yes. I think that----
Mr. Bass. And then we have another indication that in the
past, prior to that, the company had stated that reformulation
was not an option. What has changed? Is this an----
Mr. Udell. I think that Dr. Goldenheim is really the best
one to explain that to you.
Mr. Bass. Fine. Can we have Dr. Goldenheim?
Mr. Udell. Thank you, sir.
Dr. Goldenheim. Thank you. Could I just say, by way of a
preface, that I--as a physician, I am personally very
distressed by the abuse of our product. It is clearly causing
devastation. It is clearly also helping an enormous number of
people. Mr. Chairman, you have made that clear. Other people on
the panel have made that clear. As a physician, it is very
distressing that our product, when improperly used, is causing
such devastation. And, in addition to the methods and actions
that Mr. Friedman and Mr. Udell describe, we are aggressively
pursuing reformulation.
And, if I might very briefly, in 1996, we became aware that
Hydrocodone--you have heard about that drug earlier today, the
active narcotic ingredient in Vicodin--was, I think, at the
time, the most commonly abused narcotic in the United States.
And we embarked on a program to reformulate that drug because,
at the time, we were not aware of abuse of OxyContin.
We started to formulate that drug with an antagonist, with
a blocker, called Naloxone. Because it was a complicated
problem, we wanted to get advice from FDA. And we set up a
meeting with FDA, DEA, and the National Institute of Drug
Abuse, and that meeting took place in 1997. At that meeting, we
were informed that the abuse of Vicodin was via the oral route,
and you have heard a great deal about that today, how, in the
recent cases with OxyContin, much of the abuse is to crushing
the tablet and ingesting it.
We were told that Vicodin was abused orally. As a result,
we were told and advised not to use Naloxone. The reason very
simply is that Naloxone will not prevent abuse of a narcotic
orally. It will prevent the abuse when it is crushed and
injected. So, as a result of that, we switched to a different
drug called Naltrexone. The advantage of Naltrexone is that it
is absorbed orally. But now we have a very difficult problem.
Because at one in the same time we have to make sure that
enough is absorbed so that it blocks the high, if you will, so
that it blocks the abuse potential, yet, at the same time,
doesn't interfere with the pain relief. So we have got a
balancing act.
And this was a much more difficult task, a much more
difficult hurdle, that was--that we set out for ourselves. And
we have been working on that very diligently ever since.
Because if we could succeed in doing this, we could have the
formulation that would be resistant to oral abuse and
intravenous abuse and probably also snorting as well.
In 1998, we had some additional questions, wrote to the
DEA. And as recently as 1999, DEA wrote to us and again
reminded us that this was principally a problem of oral abuse.
It was not until last year, when OxyContin press became so
prevalent, when we began investigating, when we had this
meetings that were just described to you, that we learned that
in addition to the oral abuse, that OxyContin was also, on
occasion, being crushed and used intravenously. As a result of
that, we have started on a very intensive program, around the
first of this year, to formulate it with Naloxone. Again, the
Naloxone then will help prevent the intravenous abuse, but
won't do anything to prevent the oral abuse.
We have worked very closely with FDA on developing a plan
to meet today's standards for what would be required for such a
formulation, and we hope, working closely with FDA, to be able
to make a submission on a product with Naloxone some time next
year. So we are working on it very, very intensively. The
Naltrexone, the sort of broader solution, if you will, is more
complex and will take several years.
Mr. Bass. Thank you very much, doctor. Thank you, Mr.
Chairman.
Mr. Greenwood. Before Mr. Bass leaves, I would ask
unanimous consent to leave the record open for 10 business days
for additional opening statements and supplemental materials.
Without objection, it is so ordered. Mr. Bass does have to
catch a 4 o'clock train--or plane to Philadelphia. So we are
going to excuse him and thank you----
Mr. Bass. Thank you, Mr. Chairman. And thank you all for
appearing today. You have been very helpful.
Mr. Greenwood. The Chair recognizes himself for inquiry.
And let me turn to you, Dr. Levy, if I might. You heard the
testimony of Ms. Atwood, sitting next to you, about her--about
a member of her family who had the back pain resulting from an
automobile accident, was prescribed OxyContin, and then you
heard her testify about the way in which he rapidly escalated
the dosage until the issue was no longer alleviating his back
pain. I don't think he was raising the dosage because the 20
milligrams wasn't working to relieve his pain anymore. He was
doing this because of his addiction to the substance, and I
assume, because of his desire for the rush, if you will, as
opposed to just trying to get the same amount of relief of his
pain.
So could you talk to us about that? Tell us what--how does
this drug work in that regard? I am somewhat familiar with the
fact that addictive drugs, like heroin, stop the production of
normal dopamines, I think the term may be, in the brain and,
therefore, the addict starts to increase the dosage just to
maintain a level, an even keel. What is the addictive--what are
the addictive properties of this drug and how would you account
for her--Ms. Atwood's family member's experience?
Mr. Levy. I guess I would say that first we need to have a
common definition of addiction, which is the compulsive use of
a substance despite self-harm. We have many patients who have
full function on long-term doses of OxyContin, no euphoria, no
addiction, but their body can't be fixed from whatever happened
to them, whether it is the cancer, the cancer therapy, or an
incidental thing that occurred to them prior to or after that.
Mr. Greenwood. Well, let me interrupt you there. Does it--
when you are in a pain maintenance regime, does it tend to be,
generally speaking, that you can use, keep a relatively
constant dosage and maintain the palliative effect, but then,
perhaps, as the pain increases from a worsening cancerous
condition, you increase the dosage? Is that--you don't need a
continuously increasing dosage to get the same palliative
effect?
Mr. Levy. That is correct. When we are treating patients
who have opioid-responsive pain--and I think that is the key to
this--so that we keep them on the same doses for months and
years. And we have to be careful not to call them addicts any
more than we call our diabetes addicted to their Insulin.
What we are seeming to understand about tolerance, that is,
the need for more and more dose, that whereas that more and
more dose in our cancer patients is usually because there is
more and more cancer. There is another receptor, sort of key
and lock in the spinal cord, that has been studied called the
NMDA receptor. And that in many chronic pains, either from
chronic use of opioids, or from the pain emanating from nerve
damage, these receptors start to increase in their population
and those pains don't respond well to just opioids.
And if you keep increasing the opioids, you get to the
point that you are no longer treating the physical pain. You
are starting to treat the psychologic and emotional pain, that
many patients will then--the pain doesn't get any better, but
they just can take a nap. And there is the patient who starts
to get in trouble. Because when you are going to those higher
levels, that is when you are going to need more and more
Oxycodone.
What we need is better pain assessment and use of those
coanalgesics that I mentioned, a variety of medicines that were
first discovered to help people with depression or seizures or
heart rhythm problems or the installation of pumps and tubes
into the spinal cord, that can really help those kinds of pains
that all the Morphine or Oxycodone in the world won't help.
So I think the real answer to that is people need to know
when they need to refer a patient to a comprehensive center
that can look at all of the modalities, physical, invasive,
noninvasive, nonopioid, psychological, behavioral. That is the
best way to prevent the dose of any opioid from going up and
then causing the psychologic imbalance that then gets people in
trouble.
Mr. Greenwood. Well, then help me out here. I can envision
the regime where your patients with cancer come into your
center. You monitor their progress. You see them regularly.
And, as you indicated in your opening statement, not all of
your patients have cancer. You have other kinds of patients
suffering from other kinds of pains. And you are monitoring
that. You are watching that. And I can understand that. And it
seems like it is less likely you have an abusive situation
there.
Another situation that I envision, and I think it comes
from some of the reading I have done, is somewhere in West
Virginia somebody was a coal miner and he hurt his back 5 years
ago, 10 years ago. He always had pain and he has tried various
things. And his doctor meets a marketing rep from Purdue Pharma
who says you ought to try OxyContin for some of these people
who have chronic pain. He prescribes the OxyContin. And there
maybe--there doesn't necessarily--isn't this constant
interaction between physician and patient. There is a renewing
of the prescription, maybe an escalation in the dosage, and the
next thing you know, you have someone who is in the shape that
Ms. Atwood's relative was.
What should the public policy be or what should the medical
policy be? And what should--what is the drug company's
responsibility there to try to make sure that lots of the first
case happens and less of the second case? Let me throw another
question in there. And that is the question that Mr. Bass asked
the company--should this product be marketed to pain
specialists and oncologists and people who are doing what you
do exclusively, or should it, in fact, be marketed to a small-
town physician who doesn't know much about this kind of regime
and just writes the prescriptions as they are demanded by the
patient?
Mr. Levy. When I was a medical student, I participated in
putting some patients on a study of a potentially toxic
medicine for end-stage heart failure. That was in 1976, and
that medicine was Capoten, which that group of ace inhibitors
is now the standard for every physician to write for the common
starting drug of hypertension. So I think there is an evolution
of practice that the specialist in any field develop a new
drug, but we clearly can't have every person with high blood
pressure have to go to a hypertensive specialist or a
cardiologist to get that kind of medicine.
So I think we need to have eyes open and all be
responsible. I think that we spent the last 20 years teaching
physicians and nurses and pharmacists to listen to their
patients, ask them about pain, teaching the patients how to
report their pain, and much of that was funded by many of the
pharmaceutical companies that are making those Class II
medicines.
I think there is another opportunity for the next level of
education. And some of the brochures that I have seen from
Purdue Pharma are now alerting these doctors to the signs of
the side effects, the signs of abuse, the signs of
inappropriate use. Much like when Tagamet came out, it was the
best thing since sliced bread, then caused a lot of side
effects, and then there was appropriate new information. These
cycles in medicines can be up to 3 to 10 years.
I think what we need to do is to increase the education of
all clinicians on appropriate pain assessment. There are--a lot
of them--clinical education, as sort of looking as pain as a
disease. Our whole medical model was that pain was a symptom of
other diseases and that you just simply treat them and the pain
will go away. And our experience over the decades is we can't
always do that.
I think there also is the Federal--there are Federal
guidelines for State Medical Examiner Boards that talk about--
that I am sure would say that, just what you mentioned,
casually seeing--you know, giving a new script for the patient,
but not re-evaluating them every couple of months, would be bad
medicine. I mean, because we are looking for comfort and
function. And when I see a patient who needs a rapid increase
in their medicine, I am thinking, what did I miss? And we need
all clinicians to think, what is the mechanism of this pain?
What can we do specifically to deal with the pain, its
transmission, and to minimize the dose of a non-specific
opioids to try to optimize comfort and function? And that is an
education event that could use more and more Federal funding,
as well as drug company funding.
Mr. Greenwood. Let me turn to Dr. Jenkins, who has been
sitting patiently for all of these hours, from the Food and
Drug Administration. And while the Food and Drug Administration
has not offered to make an opening statement or offer
testimony, Dr. Jenkins is kind to come to answer any questions.
What policy implications might we draw here? I know that
there has been some discussion about whether or not these--this
drug can be reformulated to thwart its vulnerability to abuse.
This is a science that has been around prior to the launch of
OxyContin. And the question that occurs to me, as a legislator,
as a policymaker, is should a Class II drug like this, or
similar drugs that have this potential for abuse and for
addiction, should this whole question of inhibitors be part of
the approval process from day one, as opposed to launching a
very powerful drug like this and then coming back and trying to
close the barn doors after the horses have left?
Mr. Jenkins. Thank you, Mr. Chairman. First of all, we do
not require that the antagonist be added to opioids, at this
time, for approval. When OxyContin was approved by the FDA in
1995, it was done with the history of knowing that there were
other sustained-release narcotics already approved. We have
heard about MS-Contin. There was another compound called
Duramorph. These were Morphine products that were sustained-
released products. We had not seen evidence that those were
subject to widespread abuse and diversion. So at the time that
OxyContin was approved, it had been shown to be safe and
effective in clinical trials for treatment of moderate to
severe pain, and there was no reason, at that time, to suspect
the type of abuse that we have seen subsequently, and there was
no reason to consider requiring the addition of an antagonist.
There are issues that have to be addressed when you think
about adding an antagonist to a formulation. There are
sometimes very complicated chemical issues, formulation issues.
There are complex pharmacology issues. There is also the
fundamental question that you have to address, that most of the
patients who are receiving the combination product, don't need
the antagonist. So they are receiving a drug and being exposed
to a drug that may have its own side effects that they don't
need.
So as a policy, we have not required that opiates contain
antagonists at the time of approval. That is currently our
policy. We have been willing to work with companies in
situations where widespread abuse and diversion have become an
issue, to address whether adding an antagonist will help to
address the problem.
I think it is important, though, that adding Naloxone to
OxyContin is not going to totally solve this problem. There
will be potential ways that addicts will find to get around
that addition. And there are also question that have to be
addressed to make sure that legitimate patients still get the
pain relief that they need from the drug and that they are not
blocked by the antagonist. So it is a very complicated issue.
Mr. Greenwood. Well, you made reference, Dr. Jenkins, to
the statutory requirement that the Food and Drug Administration
must determine that a drug is both safe and effective before it
approves it for market. And the question that is occurring to
me--and I was involved in rewriting the Food and Drug
Administration Act several years ago--is whether for drugs of
this nature, that have such a potential to be abused, as well
as, as we must all continue to reiterate, the magnificent
potential is has to relieve pain, whether there ought to be an
additional standard that apply--and that is, that these drugs
be safe when used according to prescription. That they be
effective when used according to prescription and that all
practical steps are taken to reduce the likelihood of their
abuse.
And it seems to me that a product of this power, a powerful
drug like this, should, in the future, that perhaps the
Congress ought to take into consideration adding an additional
standard. And that is to make sure that the manufacturer and
the agency think through, in advance, what are the things that
need to be done in terms of marketing restrictions, if
necessary, in terms of antagonists, that may or may not be
appropriate, in terms of education, in terms of thinking
through who should the prescribers be, and who might the
prescribers not be. Maybe we need to add that step to this
process, because I don't think it exists. And, correct me if I
am wrong, I don't think it really--there is such a rigorous
process in the ordinary FDA approval process.
Mr. Jenkins. Actually, Mr. Chairman, there is. We have a
controlled substances staff in the Center for Drug Evaluation
and Research, and their responsibility is to evaluate products
that are going to be scheduled and evaluated abuse liability
and communicate with the reviewing divisions about steps that
can----
Mr. Greenwood. And that happened in the case of OxyContin?
Mr. Jenkins. I am sure it did. Remembering that Oxycodone,
the base substance in OxyContin, was already a Schedule II
narcotic in 1995, when OxyContin was approved. So it was
already going to be a Schedule II product. Now, we have learned
from the recent events and we will certainly be applying those
learnings of what we have seen with the abuse liability for
sustained-release products like this one to OxyContin and our
dealings with the company now and also to future products.
So--but abuse liability is part of what the FDA does when
we are assessing products as they are being developed. We often
see products and we have great concerns about the ability of
those products to be abused and we recommend the changes in the
formulation or packaging, or, even in vary rare cases, the
distribution and prescribing patterns for the drug, to try to
limit that abuse.
Mr. Greenwood. Ms. Atwood, let me turn to you. You
described poignantly your family member's experience, having
been injured in a car accident, taking the drug, and then
quickly accelerated the dosage and becoming essentially captive
to its power. You also treat other people who have used and
abused OxyContin. Can you talk a little bit about the profile
of those folks? For instance, do you see--have you seen in your
practice other instances of individuals who began this process
with a legitimate prescription and followed a course similar to
the one you described, as well--and to what extent to you see
that versus people who aren't experiencing pain, don't have a
legal prescription, but have become addicted to the drug by
acquiring it on the street?
Ms. Atwood. Let me start--I kind of want to jump back to
what you asked Dr. Levy. I think that a lot of times the
increase in dopamine that you were talking about, in addition
to the increase in intercellular or extracellular dopamine,
there is also an increase of indigenous opioids that happen. So
this is a really powerful thing. And I think that it is very
sad that to this point you haven't heard about the physiology
of the addiction. We know how it happens in pain, but we are
not--it wasn't discussed how it happens in addiction. And I
think that that is very sad.
Mr. Greenwood. I am all ears, if you want to get at it.
Ms. Atwood. Well, I just--I think that the same concern
that a doctor would take if a patient came in with COPD. And
knowing the side effect of the respiratory side--the
respiratory depressant side effect of that, a doctor seeing a
patient that had COPD would be very cautious----
Mr. Greenwood. What is COPD? COPD is----
Ms. Atwood. Chronic obstructive pulmonary disease.
Mr. Greenwood. Okay.
Ms. Atwood. A doctor would be very cautious in prescribing
an opiate because the opiate receptor has three parts to it,
the euphoria, the analgesic, and the respiratory depressant. So
if you know you have all three, you would be very cautious in
prescribing a respiratory depressant to somebody that already
has a respiratory depressant problem.
And what occurred to me when you talking to these gentleman
about the Naltrexone and the--those two antagonists----
Mr. Greenwood. Antagonists.
Ms. Atwood. [continuing] that maybe if doctors had the
time--I know sometimes doctors purposely don't do that, but I
don't often think that is the case, and I think that an entire
examination of the health care system as it stands today also
would be necessary in this discussion. But in any case, I think
that if we knew that this person was walking in there with a
history of the disease of addiction that then maybe there could
be a form of the drug just for them so that we weren't
medicating people that weren't addicts with the antagonists and
we were giving addicts that had pain and needed this drug with
the antagonist.
Mr. Greenwood. And are you seeing--to the question of the
street utilization, you are seeing people who have not had any
prescription whatsoever, not had any history of pain, and who
acquired this drug on the street as a so-called recreational
drug and became addicted or just be--what have you seen in that
regard?
Ms. Atwood. I would say that most times they have already
had a chemical dependency predisposition. I have seen--in
addition to my relative, I have seen 2 or 3 other kids that
came in and were on it for car-related car accident trauma that
became addicted. Otherwise, yes, it started out with
recreational use. And I think that speaks to our society and
culture.
Mr. Greenwood. I am going to ask this panel, as I did the
last panel, if there are any comments or statements or lines of
dialog that you would like to entertain that you think that we
haven't elicited with questions yet.
Mr. Udell. If I may, Mr. Chairman?
Mr. Greenwood. Yes, certainly.
Mr. Udell. At the very beginning of the hearing, Mr.
Chairman, I think you quite correctly pointed out that we are
facing the problem of prescription drug abuse in the United
States, that it is a serious problem. And I think that thread
that should run through this hearing is that we shouldn't focus
entirely on OxyContin, but we have to focus on the entire
problem of prescription drug abuse. It is quite understandable
that much of the time today has focused on OxyContin because
today, here, that seems to be the principal problem.
However, what we have seen, even in the experience of
OxyContin, we have seen this cycle in and cycle out. And the
example that I will give you of that--that explains that, sir,
is that at the very beginning of the problem, just after
Washington County, Maine, where we first observed this problem,
ground zero was Lee County, Virginia. Bucks County may be
ground zero today, but, at that time, it was Lee County,
Virginia. And Michael Friedman and I traveled to Bucks County--
--
Mr. Friedman. To Lee----
Mr. Udell. [continuing] to Lee County, Virginia, and we met
with the sheriff and the Commonwealth attorney. And I said to
Sheriff Parsons, after I heard the devastation that he
described--I said to him, sheriff, if OxyContin disappeared
from Lee County, Virginia, tomorrow, what would things be like?
And he said to me, Mr. Udell, the people who are abusing
OxyContin today would go back to abusing the drugs that they
abused before OxyContin. And what he said has proven to be the
case, because I spoke with him again just last week and I said
to him, sheriff, how are things on the streets in Lee County
today?
And he said to me, we no longer have an OxyContin problem
in Lee County. He said, we have arrested the principal doctor
who was responsible for illegal distribution of it, as has been
the case in Bucks County. And he said the efforts of law
enforcement, the cooperation of Purdue Pharma, which provided
him with placebo tablets, so that he was able to do reverse
buy-and-bust sting operations--the combined efforts of law
enforcement, the company, the medical education programs that
we have done--that we have conducted in that area, has
eliminated the problem. There is no OxyContin problem on the
streets in Lee County he told me last week.
And I said to him, and what is the condition of drug abuse
in Lee County? And he said, I am very sorry to say that the
people who were abusing OxyContin are now abusing the other
drugs--Vicodin, Percocet, Lortab, and so on. And so I think
is----
Mr. Greenwood. With equally fatal results?
Mr. Udell. You know, I have not seen recent autopsy data.
But I can say, sir, that the entire problem of prescription
drug abuse is accelerating. And if you look at the chart, which
is no longer there--if you look at the chart, what we did see
was that when OxyContin was introduced, up until just last
year, up until the year 2000, the deaths from Oxycodone-
containing products were the same as they were before. The last
year before OxyContin was introduced, I saw five deaths in that
county--five deaths. And up until the year 2000, the number was
five deaths. So I would submit, sir, that even before there was
an OxyContin, people were abusing prescription drugs and dying
from it.
And that brings me to the second point I would like to
make. Again and again we heard about education. We have got to
teach these kids that abusing a prescription drug is as
significant and as serious as abusing heroin. And we believe
that, as a company that makes a prescription drug, we have an
obligation to be a part of that process. And we have done so,
on our own. We have instituted public service announcements
directed at teenagers in areas where there is abuse, telling
them just that.
Mr. Greenwood. What is your budget for that?
Mr. Udell. I don't know what we have spent. But I can tell
you something else we have done, sir. We commissioned an
organization that specializes in marketing products to
teenagers and to preteens. And we said to them, assume that the
product that you want to sell is don't use prescription drugs.
Come up with a program directed at these teenagers and preteens
telling them that it is as dangerous to use a prescription drug
as it is to use heroin. We did that. We developed a program. We
have carried that program to people who are specialists, to
people who are experts in communicating things like this to
young people, and they have applauded it and celebrated it.
This is something where we stepped up to the plate and we did
it.
And we would like very much to make those materials
available here in Bucks County because we think that materials
like this can help in Bucks County. We have developed them and
we would like to make them available here. And I would very
much like, sir, if someone could tell us who the contacts
should be here in Bucks County so that we can start to use this
program to educate kids in this county on the dangers of
prescription drug abuse.
The third point, sir, is one that you and I have discussed
before, and that is prescription monitoring programs. I don't
think that that has been discussed here, but it really is the
answer to a lot of the questions that have been asked. When we
met the last time, you said to me, what is the one thing that
the Federal Government can do to help this problem? What do you
think we can do? And my response then is the same response it
is now, and I know that you agree with this. And that is
prescription monitoring programs.
Prescription monitoring programs have proven again and
again to be highly effective in dealing with the problem of
diversion of products like this. But there is a role that is
unique to the Federal Government. And that is, the Federal
Government can solve the problem that now exists with respect
to existing prescription monitoring programs. And that is, they
are a patchwork. They are inconsistent. There are some that are
horrible. There are some that are pretty good. And we believe,
and we have supported from inception, from the moment we
learned about this problem--and I believe we are the only
pharmaceutical company in the country that supports this--the
institution of effective prescription monitoring programs.
And we believe that the Federal Government, that the
Congress of the United States, can define standards, can set
standards for prescription monitoring programs, encourage the
States to implement them. Make them real time so that you don't
have to wait weeks or months to get the data. Make them real
time just like when you put your credit card in a restaurant,
they instantly know whether or not that credit card is good. We
have that technology and we should use it to solve this
problem. And we are encouraging States to do that and we fully
support you, sir, in your efforts to have the Federal
Government do that as well.
It is also important that a doctor in State ``A'' can query
the data base in State ``B'' to find out whether or not his
patient is going across the State line and buying prescription
drugs and getting prescriptions in another State. Now, right
now, the citizens of Pennsylvania--I am sorry--the doctors of
Pennsylvania would be unable to query a data base in New Jersey
because--if both States had prescription monitoring programs--
because the State of New Jersey doesn't recognize the authority
of a doctor in the State of Pennsylvania to do so.
And similarly, a law enforcement officer. Mr. Demarest, if
he wanted to find out what was happening across the line in New
Jersey, and New Jersey had a prescription monitoring program,
they wouldn't recognize that either. And that goes back again
to this question of cooperation and sharing of information. And
I believe there is a very important role for the Federal
Government in this area, which we fully support, in trying to
pull all of this together, establish standards and say to the
States, if you do this, it will help and we will incentivize
you to do it.
Mr. Greenwood. And, as a matter--I appreciate that. And, as
a matter of fact, it is my intention to hold a hearing in the
relatively near future on that very issue on how we can find an
appropriate Federal role in prescription monitoring programs
for the States and how we can add to that.
Let me ask you three quick questions. Is there any thought
on the part of your company of moving from the process of
paying your sales force on a commission basis on--based on the
volume of sales for this product?
Mr. Udell. The question of our compensation programs has
been raised. It was raised early on in the process and we have
considered it, we have studied it, and we have made some
changes, in part, in response to suggestions by people in
government. And we are continuing to look at this.
As we look at it today--I recently looked at a survey--I
guess it was last week--our program is consistent with that of
every other company selling drugs which are more abused than
OxyContin. And I think that this is something that has to be
studied by the industry. Now, you know, we can't combine to do
this because of antitrust considerations. But, on the other
hand, if we developed a system that was far different from that
utilized by other companies, it might be a problem in terms of
attracting qualified people to our company. And I think you are
correct that these are issues that should be studied by all
companies in the industry and we are doing so.
Mr. Greenwood. Have you considered or have you, in fact,
dedicated some percentage of your profits to rehabilitation of
your--those who have become addicted to your product?
Mr. Udell. The question of rehabilitation is an interesting
one because as we have visited with law enforcement and
government people, what occurs--what appears to us is that we
have got to work at the root causes of these problems. The
people who end up in treatment centers, they need the help.
They must get the help. But they are the people who have failed
this--where the system has failed them earlier on. And we think
that we have got to focus on that.
We have got to focus on developing abuse-resistant
formulations so that we don't create--so that people don't
become addicted to our product. We have got to do the education
of young people to make sure that they don't abuse this product
because they think it is just another drug and not as serious
as heroin. We have got to focus on educating doctors, the way
we described earlier, to make sure that they understand how to
produce these--how to use these products properly.
Those attack the root causes of the problem. And we are
committed to spending substantial sums of money in that area.
Research alone is costing us--on abuse-resistant formulations,
is costing us tens of millions of dollars each year. That is
just research alone. The development of the other programs I
have spoken about are also significant.
The fact that Michael Friedman and Howard Udell and Paul
Goldenheim are traveling all over the country trying to go to
areas where there is a problem and say how can we help? We
care. We are serious. We want to help. That has a cost too
because we are not available back home to run the business. And
we are on the road. Michael Friedman and I have been on the
road constantly since last September when we visited with Mr.
McCloskey. And that is a cost, as well, sir.
Mr. Greenwood. Okay. Mr. Levy, did you have a comment you
wanted to make?
Mr. Levy. Yes. I think, in summary, I would like to urge a
note of caution that, you know, simple problems to complex--
simple solutions to complex problems rarely work. And that we
need to be careful not to demonize Oxycodone or glorify
Naloxone. Now, you have spoken many times of the sheer potency
of Oxycodone and it, perhaps, is twice as strong as Morphine,
but Hydromorphone is four times as strong and Fentanyl is 50
times as strong.
So it isn't just the potency. It is the process of how
these medicines are used and how they then get abused. Studies
in cancer patients have documented in tens of thousands of
patients that we do not create addicts by medical prescribing.
And the several studies have been done in this country and in
Europe when we look at addicts in chronic noncancer pain
patients, like the patient, you know, with the car accident.
The same percent of the normal population that has substance
abuse, 6 to 10 percent, is that number in those who are in pain
clinics.
So we have to do this professionally. We have to, you know,
fix the problem, not the blame. We need to recognize that it
isn't that simple scientifically. There is not just three types
of things. There are, at least, 10 opioid receptors. And so it
is not that easy to jump and find a magic bullet as much as we
would like it. Attempts at mixed drugs, like Talwin, which
were--and Nubain, which were part agonist, part antagonist,
showed that they had a ceiling, they didn't relieve severe
pain, and they caused different side effects that made them
worse than pure opioids so that the Agency for Healthcare
Policy and Research says do not use them.
So we need to have a note of caution. We need, I agree, as
everyone else has said, to work together. We need to not allow
inference to creep in, such as the comment of having conversion
guidelines from Darvocet or Codeine to Oxycodone. That is
because those drugs don't work. And if we didn't tell the
physicians how to get the patient on the right dose of Morphine
or Oxycodone, we had a patient staying in pain.
So I think we need to go down to the consensus that we all
have, that we want to help patients, help our society. We
unfortunately live in a society that condones abuse. Our
society abuses alcohol, tobacco, food, and fast cars. They all
are killers. We need to have a rational public policy approach
that helps get the right medicine to the right people and the
right education to the right people. I don't think that
OxyContin is any more lethal than any other medicine. I think
because of things that have been discussed, it is
accessibility, that kids don't know that what color is what
milligrams. And that is why, I think, we have seen more deaths
from OxyContin than we have seen--you know, recently than we
have seen from Hydromorphone or Fentanyl.
So I think we need to keep it in perspective. We need to
look at our whole culture. And I hope we all have an
opportunity to work on a process together, with education and
monitoring, with appropriate resources so that we can really
get both of these epidemics under control.
Mr. Greenwood. Thank you. Ms. Atwood, any final comments?
Ms. Atwood. I would like to, first of all, thank you very
much for inviting me to be here. I think that any discussion
that has to do with addiction and drugs of abuse and so forth,
I think that the underutilization of the recovery community as
a resource and as an assistance in educating and preventing and
policing and treatment, that we are very highly effective, as
well as cost effective, resource for all of you to use. And I
wish that you would let us be available to you.
Mr. Greenwood. Thank you. Mr. Jenkins?
Mr. Jenkins. I would just like to thank you for allowing us
to be here today. We do take this problem very seriously and we
are going to do all we can, from our perspective, to try to
address this problem.
Mr. Greenwood. Well, thank you, all. This committee has a
responsibility to put issues like this under the microscope to
ask the tough questions. And we also have the responsibility
though, as legislators, to be part of the solution. And, as I
said, we will be looking into the issue of how we can do the
monitoring and how we can find Federal policy issues so that we
can, in fact, work with the manufacturers, work with the abuse
treatment community, work with evaluative community, and the
FDA to make sure that in this product and similar products
society gets to reap the benefit and minimize the anguish.
Thank you all again. I want to thank, again, Mayor Joe
DiGirolamo for generously allowing the Congress to use the
public meeting room. I also want to again thank his Executive
Assistant, Ms. Barbara Barnes, for coordinating with my staff
on this. And, finally, Mr. Ralph Douglas, the Chairman of the
Bensalem Cable Advisory Board who has volunteered to spend all
of his time here covering this broadcast and taping it for the
township. And thank you all once again. Thank you, audience,
for participating. And this hearing is adjourned.
[Whereupon, at 3:12 p.m., the subcommittee was adjourned.]
[Additional materiial submitted for the record follows:]
Prepared Statement of Edward J. Bisch
I would like to thank the members of the committee for allowing my
voice to be heard. My name is Edward Bisch from Philadelphia PA., On
Presidents day of this year. February 19, 2001 I received a call that
all parents DREAD and pray they NEVER receive. Christi my 15 year old
daughter could not wake her brother ``Eddie'' up. That was the first
day I ever heard the word OXYCONTIN. I was shocked when a police
officer came in the house and said Oxycontin, ``kids are dying left and
right from this''? I could NOT believe what I was hearing and angrily
yelled? WHY DID I NEVER HEAR OR WAS WARNED ABOUT THIS DRUG?
From that moment on I started to educate myself on Oxycontin and
started warning as many people as I could about the devastation of
abusing it. My family and I quickly decided to publicly AIR our dirty
laundry about Eddie's death to get the word out to as many people as
possible about OXYCONTIN ABUSE. We notified the MEDIA and were more
appalled when the Philadelphia Daily News reported OXYCONTIN was also
involved in 20 Philadelphia deaths within a three month period, but no
warning was given about this rising epidemic?
We called a community meeting and my sister called all the media
outlets in the City, to help us get the word to the Philadelphia region
about the DEADLY abuse of this drug. The media responded that night and
all the TV, Newspaper and News radio stations reported on the
Previously unpublicized killer.
I myself personally started a CHAIN email to also help warn people
here and throughout the country. The email then evolved into a website
(oxyABUSEkills.com) and now the website has evolved into a Nonprofit
organization called the PDAAP (Prescription Drug Abuse Awareness &
Prevention). All this is in loving Memory of my son Eddie Bisch.
Needless to say this has devastated my family and particularly
Eddie's Mom who has had several breakdowns trying to deal with this
terrible and shocking tragedy.
I commend this board for helping US bring awareness to this still
rising problem.
Since Eddie's death most of my free time has been spent either
researching or working to spread the word about OXY abuse. I have also
talked to hundreds of people all over the country through my website
from Government Agents, politicians, doctors, abusers, reporters,
informers, grieving relatives of other victims, drug companies, cancer
patients. and Chronic pain patients. Oxyabusekills.com has had over
30,000 visitors. I also volunteer and talk at schools and community
groups about OXY abuse. If there is such a thing, I would consider
myself an UNWILLING expert on OXY ABUSE.
I have learned that this is a complicated and history making
situation due to the fact that people in Severe Chronic Pain really do
need this drug and I am totally against BANNING it but I personally
feel it should ONLY be used for SEVERE PAIN because it is a very
powerful pain killer and it is too easy to FAKE moderate pain which
contributes to the diversion problem. Now that this ABUSE EPIDEMIC is
being acknowledged the question is how do we slow or stop this ABUSE
epidemic?
Winning this battle is not going to be easy, it will take the
combined efforts of the public, government, doctors, patients and
Manufacturer (PurduePharma) which has already started some education
programs.
I'd like to publicly suggest the following:
1) We need to identify and Prosecute doctor shoppers and publicize this
to let others know the FREE RIDE is over. For too long Police
have looked the other way or have not allocated enough
resources to stop this crime. Computerized monitoring is the
best way to do this BUT we need to get this speedily
implemented and all 50 states need it.
2) It should NOT take 9 months to Arrest Crooked Doctors or Pharmacists
who have been identified. Dr. Paolino of Bensalem PA. was able
to put around 300,000 pills on the street while under
investigation? This delay should be investigated and If this is
the NORMAL system then something needs to be changed to speed
it up.
3) Training should be readily available and REQUIRED for any doctor who
writes prescriptions for oxycontin. There are not enough Pain
Management Specialist to limit the prescribing to them but a
shorter course should be REQUIRED for any doctor who writes a
prescription for this powerful pain killer.
4) Doctors should be legally required to explain tolerance/dependence
to people. I have received MANY emails from legitimate patients
who were not explained anything except take twice daily, Many
of these legitimate patients eventually became abusers.
5) Legitimate patients who resell part of their prescription need to be
made aware that this is DRUG DEALING, people are DYING and this
NO LONGER will be overlooked. This is another crime law
enforcement has overlooked for too long.
6) Treatment needs to be readily available so a person who wants help
can have it immediately. the deaths are getting the headlines
but there are MANY more already addicted. If treatment is not
available then when the OXY supply does start to dry up, MANY
OXY abusers will turn to heroin.
7) Finally, Continue to educate everyone, especially teens on the
dangers of Abusing Prescription Drugs.
As you have heard in previous testimony that Most OXY related
deaths also involved other drugs including alcohol and Eddie was part
of this majority as early the day before he died, he had abused another
prescription drug XANAX.
I realize it was Prescription Drug Abuse that killed Eddie, but OXY
is the straw that is breaking the camel's back in most of these
death's, not to mention how many more are now addicted to it.
Government agencies have documented that PILL POPPING is rapidly rising
among teenagers. This is why we have founded the PDAAP, to develop
programs to educate the teens on how DANGEROUS/ADDICTIVE it is to Abuse
pills. I somehow would like to be a partner/volunteer to this committee
to help educate the children, to at least give them a fighting chance.
To properly warn them of the consequences when they choose to abuse
pills. This is the 21st century with 21st century drugs and we NEED
21st century drug education programs.
Thank you and I will help in anyway I can and ANYONE at anytime can
contact me through my website oxyABUSEkills.com. WARN ABOUT OXY ABUSE
to ENSURE ACCESS FOR PROPER USE.
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