[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
EXAMINING THE GROWING PROBLEMS OF
PRESCRIPTION DRUG AND HEROIN ABUSE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
APRIL 29, 2014
__________
Serial No. 113-140
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois FRANK PALLONE, Jr., New Jersey
JOSEPH R. PITTS, Pennsylvania BOBBY L. RUSH, Illinois
GREG WALDEN, Oregon ANNA G. ESHOO, California
LEE TERRY, Nebraska ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
PHIL GINGREY, Georgia JIM MATHESON, Utah
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio JOHN BARROW, Georgia
CATHY McMORRIS RODGERS, Washington DORIS O. MATSUI, California
GREGG HARPER, Mississippi DONNA M. CHRISTENSEN, Virgin
LEONARD LANCE, New Jersey Islands
BILL CASSIDY, Louisiana KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky JOHN P. SARBANES, Maryland
PETE OLSON, Texas JERRY McNERNEY, California
DAVID B. McKINLEY, West Virginia BRUCE L. BRALEY, Iowa
CORY GARDNER, Colorado PETER WELCH, Vermont
MIKE POMPEO, Kansas BEN RAY LUJAN, New Mexico
ADAM KINZINGER, Illinois PAUL TONKO, New York
H. MORGAN GRIFFITH, Virginia JOHN A. YARMUTH, Kentucky
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
MARSHA BLACKBURN, Tennessee BRUCE L. BRALEY, Iowa
PHIL GINGREY, Georgia BEN RAY LUJAN, New Mexico
STEVE SCALISE, Louisiana JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi G.K. BUTTERFIELD, North Carolina
PETE OLSON, Texas KATHY CASTOR, Florida
CORY GARDNER, Colorado PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
BILL JOHNSON, Ohio JOHN A. YARMUTH, Kentucky
BILLY LONG, Missouri GENE GREEN, Texas
RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
C O N T E N T S
----------
Page
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the state
of Colorado, opening statement................................. 4
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 6
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 7
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, prepared statement............... 101
Witnesses
Michael Botticelli, Acting Director, Office of National Drug
Control Policy, Executive Office of the President.............. 9
Prepared statement........................................... 12
Answers to submitted questions............................... 106
Daniel M. Sosin, Acting Director, National Center for Injury
Prevention and Control, Centers for Disease Control and
Prevention..................................................... 26
Prepared statement........................................... 28
Answers to submitted questions............................... 126
Nora D. Volkow, Director, National Institute on Drug Abuse,
National Institutes of Health.................................. 35
Prepared statement........................................... 37
Answers to submitted questions............................... 137
H. Westley Clark, Director, Center for Substance Abuse Treatment,
Substance Abuse and Mental Health Services Administration...... 53
Prepared statement........................................... 55
Answers to submitted questions............................... 150
Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Agency, U.S. Department of
Justice........................................................ 65
Prepared statement........................................... 67
Answers to submitted questions............................... 161
Submitted Material
Op-ed entitled, ``Senate must pass bills to fight tragedy of drug
addiction,'' The Courier-Journal, April 1, 2014, submitted by
Mr. Yarmuth.................................................... 103
EXAMINING THE GROWING PROBLEMS OF PRESCRIPTION DRUG AND HEROIN ABUSE
----------
TUESDAY, APRIL 29, 2014
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:00 a.m., in
room 2322 of the Rayburn House Office Building, Hon. Michael
Burgess (vice chairman of the subcommittee) presiding.
Members present: Representatives Burgess, Blackburn,
Gingrey, Scalise, Harper, Gardner, Griffith, Johnson, Long,
Ellmers, DeGette, Braley, Lujan, Schakowsky, Castor, Welch,
Yarmuth, Green and Waxman (ex officio).
Staff present: Carl Anderson, Counsel, Oversight; Karen
Christian, Chief Counsel, Oversight; Brittany Havens,
Legislative Clerk; Sean Hayes, Deputy Chief Counsel, Oversight
and Investigations; Tom Wilbur, Digital Media Advisor; Phil
Barnett, Democratic Staff Director; Brian Cohen, Democratic
Staff Director, Oversight and Investigations, Senior Policy
Advisor; Kiren Gopal, Democratic Counsel; Hannah Green,
Democratic Staff Assistant; Anne Morris Reid, Democratic Senior
Professional Staff Member; and Stephen Salsbury, Democratic
Investigator.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Good morning. I now convene the hearing of the
Subcommittee on Oversight and Investigations, entitled
Examining the Growing Problems of Prescription Drug and Heroin
Abuse.
Just a brief housekeeping detail for those of you who were
expecting to see Dr. Murphy here in the chair, he was called
away back to his district for a family issue, so you are stuck
with me, as the saying goes, but we will get through this
together.
On the issue of prescription drug and heroin abuse, these
are separate and distinct problems, but unfortunately, they do
share a common endpoint; addiction, abuse, overdose, and death.
As we know, the abuse of prescription drugs, and illegal drugs
such as heroin, have plagued our nation for decades, however,
over the last several months, there have been increasing
reports that prescription drug and heroin abuse in communities
around the country continues to grow. Sadly, those reports
indicate that overdose deaths as a result of prescription drug
and heroin abuse are also on the rise. Families have lost sons
and daughters, mothers and fathers to this addiction.
Data from the federal agencies charged with addressing drug
abuse paint a startling picture of the severity of the public
health crisis. Prescription drug abuse kills more than 16,000
people a year. From 2007 to 2012, heroin use rose by almost 80
percent in this country, and 3,000 people die each year from
heroin overdoses. The United States Attorney General, Eric
Holder, declared recently that heroin abuse constitutes ``an
urgent and growing public health crisis.''
Certainly, there is a law enforcement aspect to solving
this problem, and stopping the bad actors who illegally
distribute prescription drugs or traffic heroin, but the other
part of the equation is treating the addiction, the addiction
to prescription drugs and heroin, and preventing deaths. The
answer to a burgeoning heroin epidemic, as the Administration
has called it, is not to wage war on all opiates. To address a
complex issue, the solution cannot be simple.
The purpose of today's hearing is to examine the federal
response, including the public health response, to prescription
drug and heroin abuse. Our oversight has revealed that this is
a complex problem. Those who abuse drugs also have, often, an
underlying mental illness. Treating their addiction means that
the underlying mental illness must be successfully diagnosed
and treated. As the testimony of Mr. Botticelli states, the
substance abuse is a progressive disease. Those who suffer from
addiction often start at a young age with alcohol, maybe
marijuana, move on to other drugs like opiates. In examining
opiate abuse, we must also consider the factors that lead
people to abuse, and what we are doing to address those
factors.
Many Americans also suffer from chronic and debilitating
pain. It is important to remember that the millions of
individuals who safely use opiate narcotics under the guidance
of their physicians, pain that we hope a loved one would never
have to suffer is involved. As Dr. Volkow of NIH recognizes in
her testimony, we need to recognize the special character of
prescription drug abuse. On the one hand, we have a growing
prescription drug and opiate addiction. On the other, we have a
very real need for these drugs to treat chronic pain, treat
acute pain, and alleviate suffering where it exists, especially
in patients with chronic conditions who are suffering from
illnesses like cancer. These drugs are safe when used as
directed. It is their improper use that leads to abuse,
overdose, and death.
Over recent years, we have heard a great deal about doctor
shopping, about pill mills, and about the efforts of the
prescription drug monitoring plans to address these problems.
We need to ensure that doctors and pharmacists have the tools
at their disposal to adequately fill their role with ensuring
appropriate prescribing, but addicts also get these drugs
through illegal channels, such as rogue Internet pharmacies,
off the street, and obtaining them through family members who
may have an outdated prescription. Although some question
whether federal efforts to crackdown and prevent prescription
drug abuse have contributed to the recent rise in heroin abuse,
and whether this should have been anticipated, there is no
question that both are on the rise, and as a consequence, we
have a responsibility to recognize and solve that problem.
While most prescription drug abusers do not go on to abuse
heroin, there is data from the White House Office of National
Drug Control Policy, and the Substance Abuse and Mental Health
Services Administration, that indicates over 80 percent of
people who started using heroin in 2008 to 2010 had previously
abused prescription drugs.
The Federal Government is devoting resources to drug
control programs. Some would say significant resources; over
$25 billion annually, of which about $10 billion goes towards
drug abuse prevention and treatment programs across 19
different federal agencies. We will ask today's witnesses to
identify the specific policies, the programs, the initiatives
that have been the most effective in combatting prescription
drug and heroin abuse, and which have not. With 19 agencies
having a hand in over 70 drug control programs, we need to know
what is working and what is not. What can we do better?
Is oversight by the federal agencies also an important
issue as significant funding is block granted to the states for
their treatment programs?
Testifying before us today are representatives of five of
the agencies with lead roles in addressing opiate abuse. Mr.
Michael Botticelli, the Acting Director of the White House
Office of National Drug Control Policy; Mr. Daniel Sosin of the
Centers for Disease Control and Prevention; Dr. Nora Volkow of
the National Institute on Drug Abuse; Dr. Westley Clark of the
Substance Abuse and Mental Health Services Administration; and
Mr. Joseph Rannazzisi of the Drug Enforcement Agency.
This is a prestigious panel, and we are very grateful for
your presence here today. We certainly look forward to your
testimony.
[The prepared statement of Mr. Burgess follows:]
Prepared statement of Hon. Michael C. Burgess
Good morning. I now convene this hearing of the
Subcommittee on Oversight and Investigations entitled
``Examining the Growing Problems of Prescription Drug and
Heroin Abuse.''
These are separate and distinct problems with a common end
point; abuse, overdose, and death.
As we know, the abuse of prescription drugs and illegal
drugs such as heroin have plagued our nation for decades.
However, over the last several months, there have been
increasing reports that prescription drug and heroin abuse in
communities around the country continue to grow. Sadly, those
reports indicate that overdose deaths as a result of
prescription drug and heroin abuse are also on the rise.
Families have lost sons and daughters and fathers and mothers
to this addiction.
Data from the federal agencies charged with addressing drug
abuse paint a startling picture of the severity of this public
health crisis. Prescription drug abuse kills more than 16,000
people a year. From 2007 to 2012, heroin use rose by 79 percent
in this country and 3,000 people die each year from heroin
overdoses.
U.S. Attorney General Eric H. Holder declared recently that
heroin abuse constitutes ``an urgent and growing public health
crisis.'' Certainly, there is a law enforcement aspect to
solving this problem and stopping the bad actors who illegally
distribute prescription drugs or traffic heroin. But the other
part of the equation is treating addiction to prescription
drugs and heroin--and preventing deaths. The answer to a
burgeoning heroin epidemic, as the administration has called
it, is not to wage a war on all opioids. To address a complex
issue, the solution will not be simple.
The purpose of today's hearing is to examine the federal
response, including the public health response, to prescription
drug and heroin abuse. Our oversight has revealed that this is
a complex problem. Those who abuse drugs often have an
underlying mental illness. Treating their addiction means that
the underlying mental illness must be successfully diagnosed
and treated.
As the testimony of Mr. Botticelli, states, substance abuse
is a ``progressive disease.'' Those who suffer from addiction
often start at a young age, with alcohol and marijuana, and
then move to other drugs like opioids. In examining opioid
abuse, we must also consider the factors that lead people to
abuse--and what we are doing to address them.
Many Americans also suffer from chronic and debilitating
pain. It is important to remember the millions of individuals
who safely use opioids under the guidance of their physicians,
pain that we all hope us or a loved one would never suffer.
As Dr. Volkow of NIH recognizes in her testimony, we need
to recognize the ``special character'' of prescription drug
abuse. On one hand, we have growing prescription drug and
opiate addiction; on the other, we have the very real need for
these drugs to treat chronic pain and alleviate suffering,
especially in patients with conditions like cancer. These drugs
are safe when used as directed--it is their improper use that
leads to abuse and overdose.
Over recent years, we have heard a great deal about doctor
shopping, pill mills, and the efforts of Prescription Drug
Monitoring Plans to address these problems. We need to ensure
that doctors and pharmacists have the tools at their disposal
to adequately fill their role in ensuring appropriate
prescribing. But addicts also get these drugs through illegal
channels, such as rogue Internet pharmacies, off the street,
and obtaining them through family and friends. Although some
question whether federal efforts to crackdown or prevent
prescription drug abuse have contributed to the recent rise in
heroin abuse, and whether this should have been anticipated,
there is no question that both are on the rise and we have a
responsibility to examine this issue fully.
While most prescription drug abusers do not go on to abuse
heroin, there is data from the White House Office of National
Drug Control Policy (ONDCP) and the Substance Abuse and Mental
Health Services Administration (SAMHSA) that indicates 81
percent of people who started using heroin in 2008 to 2010 had
previously abused prescription drugs.
The federal government is devoting significant resources to
drug control programs -over $25 billion annually, of which
about $10 billion goes toward drug abuse prevention and
treatment programs across 19 federal agencies. We will ask
today's witnesses to identify the specific policies, programs,
and initiatives have been most effective in combatting
prescription drug and heroin abuse--and which have not. With 19
agencies having a hand in over 70 drug control programs--is
this working? What can we do better? Oversight by the federal
agencies is also an important issue, as significant funding is
block granted to states for treatment programs
Testifying before us today are representatives of the five
agencies with lead roles in addressing opiate abuse: Mr.
Michael Botticelli, Acting Director of the White House Office
of National Drug Control Policy; Dr. Daniel Sosin of the
Centers for Disease Control and Prevention; Dr. Nora Volkow of
the National Institute on Drug Abuse; Dr. H. Westley Clark of
the Substance Abuse and Mental Health Services Administration
(SAMHSA); and Mr. Joseph Rannazzisi of the Drug Enforcement
Agency. This is a prestigious panel, and I thank you for being
here today. We look forward to your testimony.
Mr. Burgess. I would now like to recognize for 5 minutes
for the purposes of an opening statement the ranking member,
Ms. DeGette from Colorado.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you so much, Mr. Burgess, and we are
glad to have you presiding today.
Prescription drug and heroin abuse is a public health
crisis and it is growing every day. In many communities across
the country, we are seeing an epidemic of opioid overdose
deaths. I am interested in learning from the panel about what
more we can do to prevent the abuse of these drugs, and also to
save lives.
The non-medical use of opioids has escalated in recent
years. In 2011, hospitals tallied nearly \1/2\ million
emergency room visits related to these medications. The number
of these visits nearly tripled over a 7-year period. The link
between prescription opioid use and heroin abuse is also deeply
troubling, and as the Chairman noted, only a small percentage
of people who use pain relievers go on to abuse heroin, but the
opposite is not true. The vast majority of those who abuse
heroin previously abused prescription drugs.
While far more people continue to abuse prescription drugs,
the number of individuals who reported heroin nearly doubled
between 2007 and 2012. There is also evidence to suggest that
people who abuse prescription drugs move on to heroin as pain
relievers become less available or too costly. A 2012 study in
the New England Journal of Medicine found heroin use rose
dramatically after the introduction of an abuse deterrent form
of Oxycontin.
The use of drugs that ultimately lead to addiction and
abuse often begins innocently. The majority of people who
illegally use a prescription drug get that drug from a friend
or a family member often, and sometimes the drug has been
stolen, but at other times, a parent may even give the drug to
a child, unaware of the risks. We must educate patients on the
dangers of abuse of these drugs, as well as the need to
properly store and dispose of them. If we can reduce
inappropriate access to drugs, we can also reduce the incidence
of their abuse. We must change the public perception of the
prescription opioids. We face the inaccurate perception that
just because a drug is legal, it is somehow less harmless, less
addictive and less risky. Providers should also be better
educated on the use and potential abuse of these drugs, so they
can be more effective in recognizing problems of abuse, and, in
turn, more effective in educating and treating the patients.
Studies show that even brief interventions by healthcare
providers can be successful in reducing or eliminating
substance abuse by patients who began abusing prescription
opioids but have not yet become addicted to them.
When prescribed appropriately, these medicines provide
much-needed relief, and many patients have had their suffering
reduced by opioid pain killers. However, a patient with an
acute short-term pain may be able to find relief from a less
addictive pain killer. Prescription drug abuse is a public
health problem, and it is not just a law enforcement problem.
Reducing this abuse will require a multifaceted approach, and
partnership among federal, state and local agencies. Every
state should effectively use prescription drug monitoring
programs. These databases help states identify and address drug
diversion, so they should be as robust and effective as
possible. States should be able to share information with due
regard for privacy expectations. Information should be added to
the databases regularly, including by encouraging prescribers
and pharmacists to use the databases. When used, they can help
doctors and public health authorities prevent and respond to
the potential devastating effects of prescription drug abuse.
I am interested in learning from our witnesses today about
the effects of this medication assisted treatment that we are
hearing about, and also whether we have the resources to meet
the demand for these treatment programs. I am also interested
in learning about the state of research into new medications
with lower abuse potential, and how we can expand access to
overdose interventions like naloxone.
Prescription opioid and heroin abuse, as you said, Mr.
Chairman, is a serious public health threat. I look forward to
hearing from all of the witnesses, and to working with all of
my colleagues on both sides of the aisle to ensure that
Congress plays a vital role in protecting families from the
growing danger of these drugs.
And I yield back the balance of my time.
Mr. Burgess. The gentlelady yields back.
The Chair now recognizes the gentlelady from Tennessee 5
minutes for purposes of an opening statement please.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman. And I know we are
all cheering for Congressman Murphy and his daughter, as they
are about to welcome that new baby into their family. What an
exciting, exciting time. I can only tell you the joys of being
a grandparent are marvelous. It is a big part of my day.
Well, I thank you for the attention that we are putting on
this issue. Prescription drug and heroin abuse are epidemic in
our country, and I think you can tell by what is being said in
this room this morning; it is an issue that our committee is
concerned about, and I applaud the efforts of the committee to
take a very thoughtful approach and process as how we move
forward. It is clear that we need to understand the factors
that have contributed to the rise in prescription drug and
heroin abuse. We need to understand which prevention,
treatment, and law enforcement efforts are the most effective
in reducing the abuse of prescription drugs and heroin.
On the other side of this issue are the millions of
Americans who have legitimate need for prescription medication
for the control of pain, reduction of anxiety, and the overall
improvement of their lives. These medications must be available
to them. H.R.4069, the Ensuring Patient Access and Effective
Drug Enforcement Act of 2013, that is a Bill by Representative
Marino and I, it will establish a combatting prescription drug
abuse working group. This group will include members from the
DEA, FDA, ONDCP, State Attorney Generals, patient groups,
pharmacists, industry, healthcare providers and others. Within
one year of enactment, the working group shall provide, they
must do this, provide recommendations to Congress on
initiatives to reduce prescription drug diversion and abuse. We
think this is the right approach.
We welcome each of our witnesses. We look forward to
hearing your testimony and to the discussion.
And with that, Mr. Chairman, I yield back my time, or to
anyone who is seeking time.
Mr. Burgess. Seeing no one seeking time, the gentlelady
yields back.
The Chair now recognizes the ranking member of the full
committee, Mr. Waxman, 5 minutes for an opening statement
please.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you, Mr. Chairman, for holding this
important hearing today.
We are here to discuss the epidemic of opioid abuse. The
numbers are stark. Each year, approximately 17,000 people die
from prescription opioid overdoses, and 3,000 die from heroin
overdoses.
For far too long, prescription opiate pain relievers were
prescribed too easily, without enough attention paid to the
potential risks, and a large number of people became addicted.
Some of those who became addicted to prescription opiates
eventually moved on to heroin because that is a cheaper
alternative, offering the same high.
Fortunately, there are steps that we can take to fight this
problem. I appreciate our witnesses being here today to discuss
their efforts to educate the public and providers about the
dangers of abusing these drugs. We will also hear how we can
change prescribing practices, monitor the use of opiates,
effectively treat those who are addicted, and investigate and
prosecute those involved in diverting and trafficking these
drugs.
Our five witnesses, Mr. Rannazzisi from the DEA; Mr.
Botticelli from ONDCP; Dr. Sosin from CDC; Dr. Volkow from NIH;
and Dr. Clark from SAMHSA, represent an all-star panel of
experts, and we are delighted that you are here.
There are many reasons to be thankful for the launch of the
Affordable Care Act. Let me repeat that. There are many reasons
to be thankful for the launch of the Affordable Care Act. One
that is often overlooked is the help the law offers to
individuals addicted to prescription opiates and heroin. The
lack of insurance and the high cost of treatment could present
an insurmountable barrier to receiving the help they need. The
Affordable Care Act addresses this problem by expanding
insurance coverage, and requiring all policies to cover the
costs of substance abuse services. This will mean that millions
of individuals with addiction disorders will have access to the
tools they need to help break their addictions. We need to
build upon this hopeful step, and increase our efforts to
combat this epidemic.
Mr. Chairman, at this point, I wish to yield the balance of
my time to Mr. Welch from Vermont.
Mr. Welch. I thank the member from California for yielding,
and I thank the committee for having this hearing, but I want
to give some credit to Governor Peter Shumlin of Vermont. He
did something extremely unusual. He dedicated his entire State
of the State Address to this single problem, and that was a
bold decision for two reasons. One, most of the time, the State
of the State is a laundry list of objectives and hopes. This
got very specific about one topic. But second, in taking this
on, he made public what people knew was real, but didn't want
to acknowledge. And what we have seen in Vermont as a result of
that was that we are facing what is a terrible problem that
creates enormous anxiety for the folks that are in the grip of
this addiction, but their families. And before we began talking
about this, it was restricted to our law enforcement folks and
our mental health folks who were dealing with these isolated
individuals as though they were the only ones in the world that
faced this incredible challenge. And what Governor Shumlin did
is he brought it out in the open, and that was in large part
because in his travels around, and governors do get around, he
was talking to our law enforcement people, like Chief Taylor in
Saint Albans, like Chief Baker in Rutland, and they were
dealing on the street with kids that they knew and with adults
that they knew who had jobs, but had this horrible addiction,
and they had to deal with it. And what our police kept saying,
who have frontline responsibilities, you cannot arrest your way
out of this. And there is a distinction that they make between
the dealers who came from out of state and started inflicting
our kids and others with this opiate addiction, throw the book
at them, forget about them, but a lot of the kids who are in
the grip, they are our kids, they have a future, they have a
challenge. And what has happened in our communities with the
leadership of our police and our mental health people and our
mayors, like Liz Gamache in Saint Albans, and like Chris Louras
in Rutland, is that by bringing this out into the open, it has
helped us talk about this in concrete ways so that there is not
only the treatment program, the Hub and Spoke Program, which I
hope you might talk about, but it also is allowing parents and
the community to see this as something where we all have to be
engaged to provide some basis of support for these kids and
adults who want not to be in the grip of this horrible opiate
addiction.
So I thank you, the committee, for having this hearing, and
making it a collective effort to try to bring our resources
together to help people get whole. Thank you.
Mr. Burgess. The gentleman yields back.
I would now like to introduce the witnesses on the panel
for today's hearing. Mr. Michael Botticelli is the Acting
Director of the Office of National Drug Control Policy in the
Executive Office of the President; Dr. Daniel Sosin, who is the
Acting Director of the National Center for Injury Prevention
and Control at the Centers for Disease Prevention; Dr. Nora
Volkow is the Director of the National Institute on Drug Abuse
at the National Institute of Health; Dr. Westley Clark is the
Director of the Center for Substance Abuse Treatment within the
Substance Abuse and Mental Health Services Administration; and
Mr. Joseph Rannazzisi is the Deputy Assistant Administrator in
the Office of Diversion Control within the Drug Enforcement
Agency at the United States Department of Justice.
I will now swear in the witnesses. As you are aware, this
committee is holding an investigative hearing, and when doing
so, has had the practice of taking testimony under oath. Do any
of you have any objections to testifying under oath this
morning? Seeing a negative response from the witnesses, the
Chair then advises that under the rules of the House and the
rules of the committee, you are entitled to be advised by
counsel. Do any of our witnesses desire to be advised by
counsel during testimony today? And negative response was
received from the panel of witnesses. In that case, if you
would please rise and raise your right hand, I will swear you
in.
[Witnesses sworn.]
Mr. Burgess. Let it be noted that the witnesses answered
affirmatively. You are now under oath and subject to the
penalties set forth in Title XVIII, Section 1001 of the United
States Code.
We would now welcome a 5-minute summary of your written
statements. We will start with Mr. Botticelli and move down the
table.
STATEMENTS OF MICHAEL BOTTICELLI, ACTING DIRECTOR, OFFICE OF
NATIONAL DRUG CONTROL POLICY, EXECUTIVE OFFICE OF THE
PRESIDENT; DANIEL M. SOSIN, ACTING DIRECTOR, NATIONAL CENTER
FOR INJURY PREVENTION AND CONTROL, CENTERS FOR DISEASE CONTROL
AND PREVENTION; NORA D. VOLKOW, DIRECTOR, NATIONAL INSTITUTE ON
DRUG ABUSE, NATIONAL INSTITUTES OF HEALTH; H. WESTLEY CLARK,
DIRECTOR, CENTER FOR SUBSTANCE ABUSE TREATMENT, SUBSTANCE ABUSE
AND MENTAL HEALTH SERVICES ADMINISTRATION; AND JOSEPH T.
RANNAZZISI, DEPUTY ASSISTANT ADMINISTRATOR, OFFICE OF DIVERSION
CONTROL, DRUG ENFORCEMENT AGENCY, U.S. DEPARTMENT OF JUSTICE
STATEMENT OF MICHAEL BOTTICELLI
Mr. Botticelli. Chairman Burgess, Ranking Member DeGette,
and members of the subcommittee, I want to thank you for the
opportunity to appear today to discuss the tremendous public
health and safety issues surrounding the diversion and abuse of
opioid drugs, including many prescription pain killers and
heroin, in the United States.
I know that, given recent media attention to overdose
deaths, there is a heightened public interest in the threat of
opioid drug use, but this is something many communities have
been dealing with for a very long time, and it is a matter of
great concern for this Administration.
According to the Centers for Disease Control and
Prevention, drug overdose deaths, primarily driven by
prescription opioids, now surpass homicides and traffic crashes
in the number of injury deaths in America. In 2010, the latest
year for which nationwide data are available, approximately 100
Americans died on average from overdose every day. Prescription
analgesics were involved in almost 17,000 of those deaths that
year, and heroin was involved in about 3,000, and more recent
data posted by several states indicates that deaths from heroin
continued to increase.
While heroin use remains relatively low in the United
States as compared to other drugs, there has been a troubling
increase in the number of people using heroin in recent years,
from 373,000 past-year users in 2007 to 669,000 in 2012.
It is clear that we cannot arrest our way out of the drug
problem. Science has shown us that drug addiction is a disease
of the brain, a disease that can be prevented, treated, and
from which one can recover. We know that substance use
disorders, including those driven by opioids, are a progressive
disease. Many people who develop a substance use disorder begin
using at a young age, and often start with alcohol, tobacco
and/or marijuana. We know that as an individual's abuse of
prescription opioids becomes more frequent or chronic, that
person is more inclined to purchase the drugs from dealers or
obtain prescriptions from multiple doctors, rather than simply
getting it from a friend or relative for free or without
asking. This progression of an opioid use disorder may lead an
individual to pursue a lower cost alternative such as heroin.
With these circumstances in mind, we released the Obama
Administration's inaugural National Drug Control Strategy in
2010, in which we set out a wide array of actions to expand
public health interventions and criminal justice reforms to
reduce drug use and its consequences in the United States. That
strategy noted opioid overdoses as a growing national crisis,
and set specific goals for reducing drug use, including heroin.
Three years ago, the Administration released the first
comprehensive action plan to combat the prescription drug abuse
epidemic. The Prescription Drug Abuse Prevention Plan strikes a
balance between the need to prevent diversion and abuse, and
the need to ensure legitimate access to prescription pain
medications. The Plan expands on the National Drug Control
Strategy, and brings together a variety of Federal, state,
local, and tribal partners to support: 1) the expansion of
state-based prescription drug monitoring programs; 2) more
convenient and environmentally responsible disposal methods for
removing expired or unneeded medication from the home; 3)
education for patients and training of healthcare providers in
the proper prescribing practices and treatment of substance use
disorders; and 4) reducing the prevalence of pill mills and
doctor shopping through enforcement efforts. This work has been
paralleled by efforts to address heroin trafficking and use.
The Administration is also focusing on several keys areas
to reduce and prevent opioid overdoses, including educating the
public about overdose risks and interventions, increasing
access to naloxone, an emergency overdose reversal medication,
and working with states to promote Good Samaritan laws and
other measures that can help save lives. Because police are
often the first on scene of an overdose, the Administration
strongly encourages local law enforcement agencies to train and
equip their personnel with this lifesaving drug.
It is not enough, however, to save a life from an overdose.
A smart public health approach requires us to catch the signs
and symptoms of substance use early, before it develops into a
chronic disorder. We have been encouraging the use of screening
and brief intervention to catch risky substance use before it
becomes an addiction, and since only 11 percent of those who
needed substance use disorder treatment in 2012 actually
received it, the Administration is dramatically expanding
access to treatment. The Affordable Care Act and Federal parity
law are extending access to substance use disorders and mental
health benefits for an estimated 62 million Americans, helping
to close the treatment gap and integrate substance use
treatment into mainstream healthcare. This represents the
largest expansion of treatment access in a generation and can
help guide millions into successful recovery.
The standard of care for treating substance use disorders
driven by heroin or prescription opioids involves the use of
medication-assisted treatment, an approach to treating opioid
addiction that utilizes behavioral therapy along with FDA-
approved medications, either methadone, buprenorphine, or
naltrexone. Mediation-assisted treatment has already helped
thousands of people in long-term recovery, and I applaud the
recent commentary by my HHS colleagues in the New England
Journal of Medicine to expand the use of medications to treat
opioid addiction and reduce overdose deaths.
There are some signs that our national efforts are working.
The number of Americans 12 and older initiating the non-medical
use of prescription opioids in the past year has decreased
significantly since 2009. Additionally, according to the latest
Monitoring the Future survey, the rate of past year use of
Oxycontin or Vicodin among high school seniors in 2013 is at
its lowest since 2002. And recent studies have shown that
implementation of robust naloxone distribution programs and the
expansion of medication-assisted treatment can reduce mortality
and also be cost-effective.
However, continuing challenges with prescription opioids
and the re-emergence of heroin use underscore the need for
leadership at all levels of government. We will therefore
continue to work with our Federal, state, tribal and community
partners to continue to reduce and prevent the health and
safety consequences of prescription opioids and heroin. Thank
you for the opportunity to address the committee today.
[The prepared statement of Mr. Botticelli follows:]
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Mr. Burgess. The gentleman yields back.
The Chair recognizes Dr. Sosin for the purposes of the 5-
minute opening statement please.
STATEMENT OF DANIEL M. SOSIN
Dr. Sosin. Good morning, Chairman Burgess, and members of
the subcommittee. Thank you for the opportunity to testify
about the public health issues related to prescription drug
overdoses, and the Centers for Disease Control and Prevention's
role in preventing them.
It is an honor to be with you today to talk about CDC's
approach to prescription drug overdoses and the prevention of
them.
Drug overdose death rates are higher than they have ever
been, with prescription opioids being a key driver of this
trend. More than 125,000 Americans have died from prescription
opioid overdoses in the last decade. CDC has played an
important role in raising the visibility of the health impact
of prescription opioid overdoses, and helping to identify the
role of increased inappropriate opioid prescribing in fueling
this epidemic. Research also suggests that the growth in heroin
use may be due in part to the increased addiction caused by the
rise in prescribing of opioid pain relievers.
The doubling in heroin use in the past 6 years is a
worrisome trend, and undoubtedly has a relationship to
prescription opioids. Reducing inappropriate opioid prescribing
is one of the approaches needed to keep people from becoming
addicted to opioids, and prevent them from later transitioning
to heroin.
Because of the complexity of these issues, the response
demands engagement from a diverse group of federal, state and
local partners. The partners at this table are all critical in
the overall goal to reduce abuse and overdose of opioids while
ensuring that patients with pain are safely and effectively
treated.
As the nation's health protection agency, CDC is focused on
upstream drivers of this epidemic, in this instance, the
prescribing behaviors that created and continue to fuel this
crisis. Our approach fits into three pillars that leverage
CDC's unique expertise: One, improving data quality and use to
monitor the trends and causes of the epidemic. Timely, drug-
specific information on prescribing, and the health effects of
prescription drugs is critical. We generate, use, and improve
data to identify threats, assess local trends, and evaluate the
impact of prevention measures. Two, strengthening state
prevention efforts. States maintain prescription drug
monitoring programs, or PDMPs. States regulate healthcare
professionals and institutions, they monitor the problem
through their health departments, and they run large public
insurance programs, including Medicaid. CDC provides resources
and technical assistance to states to implement interventions
and evaluate and adapt their approach to have the most impact.
And three, improving patient safety by supporting healthcare
providers and systems with tools and data needed to respond
effectively. For example, CDC is working to promote responsible
opioid prescribing through guidelines and decision support
tools.
While CDC has ongoing work in each of these areas, we are
focusing this year on accelerating state prevention efforts. We
will be funding four to five state health departments for up to
a total of $2 million per year to implement and evaluate the
strategies I just outlined.
The 2015 President's Budget includes a request for $15.6
million in new funds to expand CDC's Core Violence and Injury
Prevention Program, which is a state-based program addressing
injury and violence prevention. This will allow us to include
additional states with the high burden of prescription drug
overdose, to prevent injuries and violence, and expand the
investment of these programs on reducing prescription drug
overdose.
In conclusion, prescription drug abuse and overdose is a
serious public health problem in the United States. The burden
of prescription drug abuse and overdose affects people of all
walks of life, and many sectors of our economy. Addressing this
complex problem requires a multifaceted approach and
collaboration. CDC is committed to tracking and understanding
the epidemic, supporting states working on the frontlines of
this crisis, and rigorously evaluating what works to improve
patient safety, prevent overdoses and save lives.
Thank you again for the opportunity to be here today.
[The prepared statement of Dr. Sosin follows:]
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Mr. Burgess. Thank you. The gentleman yields back.
The Chair recognizes Dr. Volkow for 5 minutes for an
opening statement. Thank you.
STATEMENT OF NORA D. VOLKOW
Dr. Volkow [continuing]. Is a component of the NIH to speak
about the value of science in helping address the problem from
the diversion and abuse of prescription opioid pain killers,
and the related rising abuse of heroin. Opioids medications are
the most effective intervention we currently have for
management of severe pain. Unfortunately, these drugs not only
inhibit pain censors in the brain, but they also potently
activate brain reward regions, which is why they are abused and
they can cause addiction.
So we face the unique challenge of preventing their abuse,
while safeguarding their value for managing severe pain, which,
if untreated, is terribly debilitating.
It is estimated that 2.1 million Americans are addicted to
opioid pain killers, which reflects, in part, the widespread
availability of these drugs. Indeed, the number of yearly
prescriptions for opioids has more than doubled over the past
20 years, from 76 million to 207 million prescriptions per
year, during a period that in parallel saw a fourfold increase
in death overdoses from prescription opioids.
Pain killers, like Oxycontin and Vicodin, affect the brain
similarly to heroin. They interact with exactly the same opioid
receptors. Their difference depends on the potency, that is,
how strongly they activate those receptors, and how rapidly
they do so. So as for heroin, they can produce euphoria, which
some abusers of prescription medications intensify by taking
higher doses, crushing the pills so that they can snort them or
inject them, or taking them in combination with other drugs
like alcohol and Benzodiazepines. These practices make opioids
far more dangerous, not only because they are more addictive,
but also because they increase the risk for respiratory
depression, which is the main cause of death from overdoses.
Recent trends, as the other witnesses have mentioned, also
indicate a rise in heroin abuse which currently affects more
than \1/2\ million Americans, and this rise is possibly driven
in part by people switching from prescription opioids to heroin
because it is cheaper and, in some instances, more available.
Heroin is dangerous not just because of its high
addictiveness and the overdose risk that it poses, but also
because it is frequently injected which increases the risk of
diseases like HIV and Hepatitis C, predominantly from the use
of contaminated injection material.
So what is NIDA doing about the problem? We are funding
research in two major areas. One, research that will allow us
to manage pain more effectively, research that will allow us to
prevent deaths from overdoses from opioids, and that research
will allow us to treat substance use disorders more
effectively, including prescription medications.
As it relates to the safe management of pain, we still
don't know enough about the risk for addiction among chronic
pain patients, or about how pain mechanisms in the brain
interact with prescription opioids to influence their addictive
potential, but ongoing research will help us clarify some of
these issues.
So with respect to treatment, we are funding research to
develop non-opioid-based analgesics that are non-addictive,
opioid medications that have less risk for diversion and abuse,
as given by different formulations, or different ways of
administering them, and finally, non-medication strategies such
as transcranium magnetic stimulation, or electrical brain
stimulation for the management of pain.
Research related to preventing overdoses, making the
effective opioid overdose antidote, naloxone, which is also
very safe, more available, will help prevent many deaths. The
FDA recently approved a handheld auto injector of naloxone that
patients and others can use easily. NIDA is supporting the
development of user-friendly naloxones in the form of nasal
spray to be used by non-medical personnel or the overdose
victim. Also, since many overdoses occur when no one is around
or during sleep, NIDA is supporting the development of self-
activated systems that initiate an emergency response when
wireless sensors signal that an overdose is occurring.
As it relates to opioid addiction, methadone, buprenorphine
and naltrexone have been shown to be effective in treating
opioid addiction, and in preventing overdoses, but these
medications are not being used widely. NIDA is working to
overcome the barriers that interfere with their adoption. In
parallel, research of new interventions such as vaccines for
heroin will allow us to treat this problem in a different way
and to prevent it. Additionally, we work with our partners,
CDC, SAMHSA, ONDCP and ONC in implementing and evaluating
evidence-based interventions.
Again, I want to thank you for recognizing the urgency of
the problem posed by the abuse of prescription opioids, and for
inviting NIDA to discuss how science can help address this
problem.
[The prepared statement of Dr. Volkow follows:]
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Mr. Burgess. The Chair thanks the doctor. The gentlelady
yields back.
Chair recognizes Dr. Clark 5 minutes for the purposes of
summary of your opening statement please. Your microphone, sir.
STATEMENT OF H. WESTLEY CLARK
Dr. Clark. Thank you for inviting the Substance Abuse and
Mental Health Services Administration to participate in this
panel.
I echo the testimony of my colleagues regarding the
importance of the topics of this hearing. I will focus on
SAMHSA's programs and activities, but I want to point out that
we work with our federal partners: with states, tribes and
local communities. According to the National Survey on Drug Use
and Health, which SAMHSA conducts, 4.9 million people reported
non-medical use of pain relievers during the past month in
2012, 335,000 reported past month use of heroin, a figure that
has more than doubled in 6 years. In 2012, more than 1.89
million people reported initiating non-medical use of pain
relievers, and 156,000 reported initiating use of heroin. One
challenge in combating the misuse of pain relievers is
educating the public on dangers of sharing medications.
According to our national survey, 54 percent of those who
obtained pain relievers for non-medical use in the past year
received them from a friend or relative for free. Another 14.9
percent either bought them or took them from a friend or
relative. Thus, we have both the public health problem
intertwined with a cultural problem.
SAMHSA has several programs focused on educating the
public, including the ``Not Worth the Risk Even If It's Legal''
campaign, which encourages parents to talk to their teens about
preventing prescription drug abuse, our ``Prevention of
Prescription Abuse in the Workplace'' effort supports programs
for employers, employees, and their families. Our Partnership
for Success grant includes prescription drug abuse prevention,
as one of the capacity building activities in communities of
high need. Our Screening, Brief Intervention and Referral to
Treatment Program includes screening for illicit drugs,
including heroin and other opioids. We have developed programs
to help physicians maintain a balance between providing
appropriate pain management, and minimizing the risk of pain
medication misuse. Our expert medical residency program
includes a module for prescription opioids for pain management
and opioid misuse. Over 6,000 medical residents and over 13,700
non-residents have been trained nationally. Our physician
clinical support system for Medication Assisted Treatment
training is available via live in-person, live Online, and
recorded modules, accessible at any time. SAMHSA funds a
Prescribers' Clinical Support System for Opioid Therapies, a
collaborative project led by the American Academy of Addiction
Psychiatry, with six other leading medical societies. We will
be funding a Providers' Clinical Support System on the
Appropriate Use of Opioids in the Treatment of Pain and Opioid-
related Addiction this fiscal year.
Last week's article in the New England Journal of Medicine,
authored by HHS leadership, including Dr. Volkow and SAMHSA's
administrator, describes the underutilization of vital
medications and addiction treatment services, and discusses
ongoing efforts by major public health agencies to encourage
their use.
Medication-assisted treatment includes three strategies:
agonist therapy, which includes Methadone maintenance; partial
agonist therapy, which includes buprenorphine; and antagonist
therapy, which uses an extended release injectable naltrexone,
or Vivitrol.
SAMHSA is responsible for overseeing the regulatory
compliance of certified Opioid Treatment Programs which use
methadone and/or buprenorphine for treatment of opioid
addiction. We estimate that there are approximately 300,000
people receiving methadone maintenance. There are currently
26,000 physicians with a waiver to prescribe buprenorphine; of
these, 7,700 are authorized to prescribe up to 100 patients. We
estimate that there are 1.2 million people receiving
buprenorphine.
SAMHSA also issued an advisory encouraging drug courts to
utilize Vivitrol in their treatment programs. In August of
2013, we published the Opioid Overdose Tool Kit to educate
families, first responders, individuals, prescribing providers,
and community members about steps to take to prevent and treat
opioid overdose, including the use of naloxone. When
administered quickly and effectively, naloxone restores
breathing to a victim in the throes of an opioid overdose. This
can be used as a teachable moment to assess treatment need and
refer the person to the appropriate resources. We inform states
and jurisdictions that the Substance Abuse Prevention and
Treatment Block Grant primary prevention set-aside funds may be
utilized to support overdose prevention education and training.
In addition, we notified jurisdictions that block grants, other
than the primary prevention set-aside funds, may be used to
purchase naloxone and the necessary materials to assemble
overdose kits to cover the costs associated with the
dissemination of such kits.
SAMHSA continues to focus on our mission of reducing the
impact of substance abuse and mental illness on America's
communities, and we thank the subcommittee chairman and members
for convening this important hearing, and providing SAMHSA with
the opportunity to address this very critical issue.
[The prepared statement of Dr. Clark follows:]
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Mr. Burgess. The gentleman yields back.
The Chair now recognizes Mr. Rannazzisi 5 minutes for the
purposes of summarizing your testimony please, sir.
STATEMENT OF JOSEPH T. RANNAZZISI
Mr. Rannazzisi. Thank you, Chairman Burgess, and
distinguished members of the subcommittee. On behalf of
DEAAdministrator, Michele Leonhart, and the men and women of
the Drug Enforcement Administration, I want to thank you for
the opportunity to discuss today the relationship between
prescription opioids and heroin, and how DEA is addressing the
public health problem.
First, let me say that the present state of affairs is not
a surprise. DEA has been concerned about the connection between
the rising prescription opioid diversion and abuse problem, and
rising heroin trafficking use for several years. The DEA
believes that increased heroin use is driven by many factors,
including the increase and the misuse and abuse of prescription
opioids. The signs have been there for some time now.
Law enforcement agencies across the country have been
reporting an increase in heroin use by teens and young adults
who began their cycle of abuse with prescription opioids.
Treatment providers report that opioid addicted individuals
switch between prescription opioids and heroin, depending on
price and availability. Non-medical prescription opioid use,
particularly by teens and young adults, can easily lead to
heroin use. Heroin traffickers know all this, and are
relocating to areas where prescription drug abuse is on the
rise.
To give you an example, we know that many teens and young
adults first get their prescription opioids for free, from
medicine cabinets or friends. Let us assume that a teenager
gets hydrocodone, a Schedule III prescription opioid, and also
the most prescribed drug in the United States, from a family
medicine cabinet or friend. Once that free source runs out, it
could cost as little as between $5 and $7 a tablet on the
street, but then the teen will eventually need more opioid to
get the same effect that he is trying to achieve. Black market
sales for prescription drugs are typically 5 to 10 times their
retail value. On the street, a Schedule II prescription opioid
can cost anywhere from $40 to $80 per tablet, depending on the
relative strength of the drug. These increasing costs make it
difficult to continue purchasing, especially for teens and
young adults who don't have steady sources of income. Given the
high cost to maintain this high, the teenager turns to heroin
at a street cost of generally $10 a bag. The teenager gets a
high similar to the one he got when he abused prescription
drugs. It is just that easy.
Any long-term solution to reduce opioid abuse must include
actions to address prescription drug diversion and misuse,
while also educating the public about the dangers of non-
medical use of pharmaceuticals, educating prescribers and
pharmacists and treating those individuals who have moved from
misuse and abuse to addiction.
The DEA currently operates 66 tactical diversion squads in
41 states, the District of Columbia and the Caribbean. These
groups capitalize on combined law enforcement authorities of
task force officers and DEA agents to conduct criminal
investigations in the diversion of pharmaceutical drugs. The
DEA regulates more than 1.5 million registrants. DEA diversion
groups concentrate on the regulatory aspects of enforcing the
Controlled Substances Act, utilizing increased compliance
inspections. This oversight enables DEA to proactively educate
registrants, and ensure that DEA registrants understand and
comply with the law.
The tactical diversion squads and the diversion groups have
brought their skills to bear on what was previously known as
ground zero for prescription drug use, Florida-based Internet
pharmacies and pain clinics. As the current pill mill threat is
driven out of Florida and moves north and northwest, DEA will
continue to target the threat with the tactical diversion
groups' proven law enforcement skills, the diversion groups'
regulatory expertise, and by educating registrants.
DEA and our law enforcement partners have aggressively
targeted both prescription drug diversion and heroin
trafficking. From 2001 to 2012, there has been a staggering
increase in drug analysis of opioid pain medications, 275
percent for oxycodone, 197 percent for hydrocodone, and 334
percent for morphine. There has also been a significant
increase in heroin cases. From 2008 to 2012, there was a 35
percent increase. If the data for the first half of 2013
remains constant, the increase from 2008 to 2013 would be
approximately 51 percent.
The increase in heroin abuse and trafficking is a symptom
of our country's appetite for prescription opioids that will
eventually lead to abuse and addiction. It is a natural
progression from the abuse of prescription opioids.
There is a dangerous misperception that abusing
prescription drugs is safer than abusing heroin. Both abuse of
prescription opioids and heroin can lead to addiction and
death. Preventing the availability of pharmaceutical controlled
substances to non-medical users, and educating practitioners,
pharmacists, and the public about pharmaceutical diversion,
trafficking and abuse are priorities at DEA. As such, DEA will
continue to work in a cooperative effort with other federal,
state, and local officials, law enforcement, professional
organizations, and community groups to address this epidemic.
Thank you for your invitation to appear today, and I look
forward to answering any questions that you may have. Thank
you.
[The prepared statement of Mr. Rannazzisi follows:]
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Mr. Burgess. The gentleman yields back. I thank the
gentleman for his testimony.
We will now hear from the members for questions, 5 minutes
for each member.
I will begin.
Well, Mr. Rannazzisi, you just gave some rather startling
statistics. Mr. Botticelli, you said in your testimony we can't
arrest our way out of this problem. So let me just ask you,
from a federal perspective, we have put a lot of money and a
lot of effort on behalf of taxpayers into this, what is it
about this that is not working?
Mr. Botticelli, we will start with you, and maybe we can
just go down the line and just answer the question, how has
this become the problem that it is?
Mr. Botticelli. Sure. I think a number of my Federal
panelists have articulated some of the problems, and I think,
first and foremost, a lot of this issue is driven by the vast
overprescribing of prescription pain medication. A recent
report by the GAO showed that the vast majority of physicians
get little to no training in substance use disorders and little
to no training in safe opioid prescribing. And a part of our--
--
Mr. Burgess. Let me stop you there because this is not a
new problem. I mean this was a problem 40 years ago when I was
in medical school, and I would disagree with the statement that
we got no training, but OK, the training may not be adequate to
the scope of the problem, but honestly, can we say that this is
something that just happened to us, and we were completely
unaware that this was an issue? I mean how could you possibly
make a statement like that?
Mr. Botticelli. I think part of what the balance has been,
and I think it has been out of kilter, is that physicians,
quite honestly, were pushed in terms of making sure that we
adequately treated pain in the United States. And we absolutely
need to make sure that we do that. I think we need to have a
balanced strategy that understands the tremendous addiction
potential of these drugs, the risky patients that we have
before us in terms of who should be prescribed prescription
medication, as well as monitoring those who are developing a
problem.
So I do think that this is a balanced approach in terms of
both making sure that we are adequately treating pain, but we
are also not inadvertently creating a problem by
overprescribing these medications to people who are developing
a problem, or who are at risk.
Mr. Burgess. I don't want to put words in his mouth, but
Mr. Rannazzisi seemed to imply that we are overprescribing. Is
that a fair assessment of your testimony?
Mr. Rannazzisi. I think that if you are talking about 99.5
percent of the prescribers, no, they are not overprescribing,
but our focus is in rogue pain clinics and rogue doctors who
are overprescribing. Actually, they are prescribing illegally,
they are not overprescribing, they are illegally prescribing.
So, yes, if you are considering that overprescribing, yes.
Mr. Burgess. Well, that is your job. You are law
enforcement, so you get to close them down, right?
Mr. Rannazzisi. And we are trying. They are overwhelming us
with numbers.
Mr. Burgess. All right, I do want everyone's response to
that because in the interests of time and wanting to keep to
the 5-minute interval, I am going to submit that in writing to
each of you.
I want to bring up something because each--or several of
you have brought it up, and that is the issue of making
naloxone much more available. Maybe we should also be talking
about making Ambu bags available for people who are going to
overdose. I mean it is hard to know who is going to overdose,
but, Mr. Botticelli, you brought it up, and I think, Dr. Sosin,
you brought it up as well, but what is the issue here with
making this available?
Mr. Botticelli. I think that we have been tremendously
heartened, both at the Federal level, as Dr. Volkow talked
about, in terms of the approval of new delivery devices for
doing that. One of the main areas that ONDCP has been working
with our state partners is the passage of state legislation to
look at naloxone distribution. And so I think we have now 17
states that have enacted naloxone distribution legislation,
which I think has really been helpful here.
We have also been, quite honestly, working with many law
enforcement agencies across the state----
Mr. Burgess. Pardon me for a moment. It is a federally
controlled substance, is it not? Naloxone?
Mr. Botticelli. It is not a controlled substance, if I
remember correctly.
Mr. Burgess. OK. Is there a cost issue?
Mr. Botticelli. There is a cost issue, and one of the
things, Chairman, that you asked is what are the opportunities
that we have in terms of looking at this, and again, I think it
was really helpful that SAMHSA looked at how we might use
existing Federal funds, but I think if there is an area that we
can continue to explore together it is how we might enhance
resources for many overdose prevention efforts.
One of the things that I have heard as I have traveled
around the country is that having state legislation and having
these devices is a great start, but many states and local areas
are under-resourced in terms of implementing it.
Mr. Burgess. Yes, and again, I may submit that in--for
answer in writing as well, but, Dr. Volkow, let me just ask
you. You mentioned in your testimony to address this problem,
we have to recognize the special character of this phenomenon,
and part of which is that opiates play a key role in relieving
suffering. So as providers and policymakers, are we doing a
good job of walking this line?
Dr. Volkow. Based on the numbers, I don't think we can say
we are, and the reality is that in this country, we have both
an under-treatment of pain and over-prescription of
medications. These are not exclusive. And one of the issues
that we have been faced with, and Mr. Botticelli had been
discussing is, in 2000, when the Joint Committee for
Accreditation of Hospital demanded that you treat pain, you see
a steep increase in the number of prescriptions. So what you
are doing in parallel, there has not been an increase in
education in medical schools. So each 7 hours average in the
United States there is a diversity of opiate medications that
are currently available, and there are many indications where
actually patients are being given the opioids when it is not
severe pain, and this, for example, is the case in many cases
for young people with dentists that are prescribing the opiate
medication, so there is a room for improvement on that
education of providers.
The other issue too that we have not understood very much
when we were--I mean certainly, when I was in medical school,
they will tell you if you prescribe an opioid medication with
someone that is suffering from pain, they are not going to
become addicted. Now, we can come to recognize that it is not
the case, that there are patients that are taking the
medication as prescribed, and they can become addicted. So the
issue is who are they, how do we recognize them so we can
prevent that transition. And----
Mr. Burgess. Well, and my time has expired. I will just
offer the observation, 40 years ago, I was given the admonition
by a professor in anesthesiology, this stuff is so good, don't
even try it once. So clearly, it was known 40 years ago.
I recognize Mr. Welch for 5 minutes for questions please.
Mr. Welch. OK, I want to thank the panel and the Chairman
as well.
You know, in Vermont, as I mentioned in my opening
statement, we are just trying to face this directly, which is,
I think, a much better approach than denial, and it has engaged
the community in some very effective ways. And it has
developed--I think it has helped our providers develop what
they call a Hub and Spoke System where there is an emphasis on
medication, which really does seem to be helping some folks who
are willing to be helped, and then some wraparound treatment
services for people who can benefit by that. And a lot of our
ability to do that is because we are getting some federal help.
We get about $6 million out of the Substance Abuse Prevention
and Treatment Block Grant. That has been level funded. And my
question really to Mr. Clark, can you explain the decision, I
guess this is the Administration decision not to propose an
increase in that program, given the intensity of the crisis.
And I think with this discussion occurring all around the
country, obviously, you are going to have many more states that
are willing to roll up their sleeves and try to get engaged,
which would suggest the resource need is there in order to help
make this successful.
Dr. Clark?
Dr. Clark. Mr. Welch, we are working very closely with
state authorities, with organizations like NASADAD and NASMHPD
to address these issues, but we also, as Mr. Botticelli pointed
out, are approaching this from a comprehensive approach rather
than simply using a single funding mechanism to address the
issue. We need to keep in mind that we need multiple strategies
to address this problem, and with those multiple strategies, we
believe that we can make an impact. So relying, indeed, on the
Affordable Care Act and other strategies, we can leverage the
Block Grant Funding to target this.
We are also allowing jurisdictions to prioritize using our
prevention efforts, as well as our treatment efforts. The
problems that they are experiencing----
Mr. Welch. All right.
Dr. Clark [continuing]. In their respective jurisdictions--
--
Mr. Welch. OK, thank you. No--but no more money. Money is
tight, I get it.
And, Mr. Botticelli, your predecessor came up and had a
great visit with us in Vermont. It was tremendous to have him
there. And we have expanded the use of naloxone--how do you say
that?
Mr. Botticelli. Naloxone.
Mr. Welch. Naloxone. Yes, and we have had some success with
that. We have had a number of instances of it being used
successfully just recently about 15 times.
But do you think that the FDA should consider making that
an over-the-counter medication?
Mr. Botticelli. Yes. So, first of all, like you, I really
want to applaud you and Governor Shumlin in terms of calling
significant attention to this issue. I spent the better part of
my career in Massachusetts, and am very familiar with----
Mr. Welch. Right.
Mr. Botticelli [continuing]. The heroin issue that we have
had in New England for a long, long time.
Our office, as part of our prescription drug abuse plan and
overdose, has been looking for continued ways to expand the use
of naloxone. Again, I think we are heartened by this delivery
device. Our partners at NIDA are looking at and researching the
expansion of and use of other ways. So we are having
conversations with both Federal partners and, quite honestly,
some external stakeholders who are really, really interested in
terms of looking at how do we increase the--not only the
availability of naloxone, but continue to promote easier to use
and, quite honestly----
Mr. Welch. OK.
Mr. Botticelli [continuing]. Perhaps some cheaper versions
of----
Mr. Welch. Right.
Mr. Botticelli [continuing]. Naloxone.
Mr. Welch. I have time for one more question.
Dr. Volkow, I want to ask you about this issue with doctors
and with patients. I have known close friends who have had
serious medical issues and have been in a lot of pain, and once
that line is crossed where they are getting the prescription
medication, it almost seems like there is an undertow where the
answer to the pain question always is essentially to get more
medication and more powerful medication. And a patient in that
moment is pretty vulnerable. And the doctor gets really
persistent advocacy by the patient and sometimes the patient's
family. You have got to do something. So how do we help the
doctors deal with what, Dr. Burgess, of course, we have another
doctor here, but how do they, there are a lot of doctors around
here, but how do we--the doctors really have to be on the
frontline, and it is very tough because they have a patient who
is in pain, they have a family who is saying will you do
something, but the something that is getting done in many cases
is resulting in long-term problems.
Dr. Volkow. Yes, and you are touching on one of the hardest
issues to deal with clinically: how do you manage severe
chronic pain. What many people don't know is that the risk of
suicide for patients with chronic pain is double that of the
general population, so it is extraordinarily debilitating. And
the strongest medication we have are opioids. The problem with
opioids, apart from addictiveness, is that you become tolerant
very rapidly, and so that requires that you increase the dose.
So chronically, and then you have to shift to something more
potent, and that is exactly where the whole problem lies
around. They are not ideal, but it is what we have, and it can
relieve the patients in the moment that they need them.
The strategy is what other alternatives we can use other
than just relying as--in opioids as the only alternative, and
that is where research is ongoing to see--that is what I was
mentioning in the whole area of brain neuroscience, the
feasibility of devices that can actually be used potentially to
handle and manage pain will be a breakthrough. You will rely
less on medications. And I also think the aspect of we as a
society have created the expectation that anything that is
wrong with you should be treated with a medication. So zero
tolerance for pain. And I think that as a culture, we need to
revision that also.
Mr. Welch. Thank you.
I yield back. Thank you very much.
Mr. Gingrey [presiding]. Thank you. Thank you, Mr. Welch.
And I am sitting in, obviously, for Dr. Burgess. Let me
just make a brief statement, and then I will ask my question.
As a physician of many years, I don't think that even back
in the day we were given the proper training in regard to pain
medication. Also I will say this, there has been a lot of
emphasis over the past 10 years or so about advanced directives
and the necessity for that, and, of course, the hospice
programs that have developed and that sort of thing, but I
don't hear hardly any discussion about patients given their
wishes in regard to how they want their pain controlled in a
terminal situation where there is no chance for recovery. I
don't know that people really understand, and in many instances
pain medication is started because the family members don't
want their loved one to suffer. That is quite natural and
appropriate, but before you know it, the patient has gone
beyond the stage where they can say, look, I don't want to be
totally zonked out at the time of my demise. So that is just, I
guess, food for thought in a way.
I am going to ask my specific question, Mr. Rannazzisi. You
said earlier in your testimony that the DEA is just getting
overwhelmed by all these rogue pain clinics that are popping up
everywhere. How is that happening? How do these places just pop
up, as you put it, and why is it happening, why are you getting
overwhelmed?
Mr. Rannazzisi. Well, that is a great question, sir. It is
not just DEA that is overwhelmed. Our state and local
counterparts are overwhelmed. Think about this. Prior to the
Ryan Haight Act, the Internet drug bill that was passed, there
were, say, seven clinics--pain clinics in Broward County, in
2010 there were 142 clinics in Broward County. Now, if you
look, when we moved our enforcement groups down there, and we
moved 10 tactical diversion squads to work with our state and
local counterparts, and we started knocking off these rogue
pain clinics, they moved up into Georgia. If you looked at the
75 corridor, there were over 100 pain clinics going up that 75
corridor. Some of them were right off of the interstate. You
just get off and get back on. Then they moved into Tennessee.
Tennessee now has approximately 300 clinics.
Now, if you think that--state and local law enforcement and
DEA doesn't have the capacity to go after every one of these
clinics quickly, because these are legal drugs that they are
peddling, and we have to establish that that doctor is
prescribing outside the usual course of professional practice,
and not for legitimate medical purposes. It takes time. These
cases take time. So what they are doing is they are just
counting on the fact that they are going to run the clinic that
is not being hit by DEA. So we are all overwhelmed, everyone in
law enforcement.
Mr. Gingrey. Yes, but what percentage would you say of
these clinics are fraudulent?
Mr. Rannazzisi. In Florida, the vast majority of them. In
Georgia, I believe that the vast majority of those clinics that
popped up were. There are good pain clinics, don't get me
wrong. Every pain clinic is not bad.
Mr. Gingrey. Yes.
Mr. Rannazzisi. But the pain clinics that we are looking at
are absolutely atrocious. There is no medical care.
Mr. Gingrey. Yes.
Mr. Rannazzisi. It is the modern-day crack house.
Mr. Gingrey. Thank you for that answer.
And any of you could answer this. Last year, GAO, the
Government Accountability Office, found an overlap in 59 of the
76 programs it identified in the drug abuse and prevention
area. What steps are any of your agencies taking to minimize
overlap and more efficiently spend out taxpayer dollars? I mean
you would think that we could get some efficiency here.
Anybody?
Mr. Botticelli. Sure, Chairman. Our office has looked at
that report and has been working with our Federal partners to
look at the breadth of our prevention programs, and to make
sure that we are not, quite honestly, duplicating programs.
I do think that, however, if you talk to many, many people
at the local level, they will tell you, however, that we don't
have enough prevention, and I think you heard from many, many
folks up here that while we may have programs that are
addressing the same issue, they are reaching not the entirety
of the population. So we really want to make sure that, one,
that we are not kind of duplicating the programs that we have
already----
Mr. Gingrey. Well, very important, I would think that you
guys are talking to each other, of course. Others? I have a
little time left, 2 seconds, 1 second. Wait a minute, I am the
chair now, aren't I? I have 5 minutes left. Mr. Clark?
Dr. Clark. Well, as----
Mr. Gingrey. Dr. Clark, excuse me.
Dr. Clark. One of the things we are concerned about in the
Administration is the issue of fragmentation, overlap, and
duplication, and that we do work very closely with our federal
partners to make sure that we minimize fragmentation, overlap,
and duplication. And working under the assistance of ONDCP, we
are able to address that.
As was pointed out, communities need multiple resources,
and you find that sometimes you cannot completely eliminate
some overlap because, indeed, the unique issues of individual
communities require that there be some overlap, but we are very
sensitive to both the GAO concerns and OMB's concerns about
fragmentation, overlap, and duplication, and assiduously try to
avoid that.
Mr. Gingrey. Thank you all. I thank the panel. My time has
expired, and I yield 5 minutes now to Mr. Lujan.
Mr. Lujan. Mr. Chairman, Doctor, thank you so very much for
the time today, and I am glad to see that we are having this
hearing. This is important. By the chairman and the committee
staff acknowledging that this hearing needed to take place, I
think we are acknowledging there is a problem across the
country.
The question after this hearing today though is, are we
going to sweep this under the rug again, or are we going to do
something significant with recommendations that are going to
come from experts?
This is a problem plaguing America. The case in New York
brought more attention to what was happening with heroin abuse
and overdoses, but we have been losing lives across the country
for years. And what are we going to do? There are
recommendations that have been put on the table by many
experts. It has been studied over and over and over. There is a
program from 2011 on the prescription drug side to reduce abuse
significantly over 5 years, I will be asking the question where
are we with that, but every life that is lost as a result of
this is one life too many.
There are only so many parts of the world that are growing
poppies. Do we not know, as the United States of America, where
poppies are being grown and how they are migrating into the
United States in the form of heroin and illegal substances?
Seems to me we should. And what are we doing to stop that flow?
That is very troubling.
Now, going back to the prescription drug side, there have
been presentations that we have seen in New Mexico that have
been put together by some people that I respect very much, that
show a correlation with drug overdoses with increased
prescriptions that are coming out, not just pain medication
facilities that are popping up. And so one of the questions
that I have is, is there data that is reported to any of you
that you do analysis on, where there is a court--at least with
the data that I have seen, there is--it is shown that there is
a correlation between overdoses and increased prescriptions
that are being administered, and what do we do with that data?
Are we able to go in or is that an area where we don't have
enough support now between the federal and the state partners?
And I would ask anyone that would like to tackle that.
Dr. Sosin. Thank you, Congressman Lujan.
You mentioned a New Mexico report. Dr. Paulozzi from CDC
worked with scientists in New Mexico and health department
staff there to analyze and demonstrate those relationships, and
absolutely, there is a very tight relationship between the
volume of opioid prescribing and opioid overdose deaths. That
information does get used at a national level, and thinking
about the areas to intervene, but also at the state and local
level where it has to be, to better understand how the problems
in each individual jurisdiction, and the factors that are
influencing the prescribing practices are being addressed
there.
One of the ways that CDC in particular works is by trying
to liberate data by working with state and local health
departments to understand the context of prescribing, of health
system data, and of mortality data, to put a better picture and
understand the context within which overdose deaths are
occurring and abuse is occurring, and then be able to target
programs like through their PDMP's, like restriction programs,
et cetera, that address those problems.
Dr. Volkow. If I may, first of all, I want to thank you for
bringing up that issue because the way that I view it, this is
an urgent issue and we cannot put it under the rug, under no
conditions. And I feel passionate because I do get the parents
coming to me and say when we went to wake up our child, it was
dead, and we didn't even know that they were abusing opioids.
The other issue is that we do have the tools to actually
address the problem of opioid prescription abuse and opioid
deaths. We need to implement them. We have treatments that work
for drug addiction that can decrease the number of overdoses,
but also we need to address the problem that we have with
chronic pain in this country. How many people suffer chronic
pain in this country? Estimated IOM, 100 million. 100 million.
There is the notion on that 100--that there is an increase in
chronic pain, and that needs to be addressed. So from the
healthcare perspective, we need to address it.
Mr. Lujan. And, Dr. Volkow, as my time expires, there are
some questions that I will be submitting in to the record, but
I would welcome your response as well.
And, Mr. Chairman, I just wanted to share with you that
there is a program in New Mexico that appears to be working
with the distribution of Narcon, where there has been a
reversal of more than 250 overdoses last year, where they are
getting it into the hands of first responders and nurses. So it
is not necessarily on the street, but it is with those that are
responding to these accidents. And there may be a way for us to
work on that with some ideas down the road.
Mr. Chairman, again, I share, before you return to the
hearing, how much we appreciate that you are doing this and you
have brought this hearing, but I certainly hope that there is
more that will be done, and that this hearing won't be the last
of hearings and conversations, and an approach that we can take
as a Congress to work with our state partners to do something.
This is a bad problem across the country, but it is also
plaguing New Mexico. And I thank you for your attention to
this, Mr. Chairman.
Mr. Burgess. The Chair thanks the gentleman, and does also
observe that further hearings are likely to be necessary, and
as Mr. Welch pointed out, to hear from governors, and I would
like to hear from some of our mayors because they are on the
first lines of this battle.
The Chair now recognizes the gentlelady from North
Carolina, Mrs. Ellmers, 5 minutes for questions please.
Mrs. Ellmers. Thank you, Mr. Chairman, and thank you to our
panel for being here today, addressing this very important
issue.
I would like to start by asking a question of Mr.
Botticelli and Dr. Volkow.
Understanding the path of addiction, there is, and I think
you have both identified a genetic basis for that, one of the
things I would like to know is, again, the progression. Is this
something that starts with tobacco use, smoking, use of
alcohol, drinking, and then how does it progress and how do you
feel? And I will just start with you, Mr. Botticelli, and then
have Dr. Volkow comment.
Mr. Botticelli. I do have to acknowledge that just about
everything that this field knows about this has come from the
work of Dr. Volkow.
Clearly, we know that there is a genetic predisposition for
many people in terms of family history of substance abuse, but
we also know that there is, like many diseases, there are
environmental factors that go into that issue.
We know that substance use disorders are a disease of early
onset, so that many people who do develop, left untreated, left
undiagnosed, develop a substance use disorder, largely because
of starting alcohol, tobacco and/or marijuana use----
Mrs. Ellmers. Yes.
Mr. Botticelli. At a very young age. Clearly, there are
some particular issues as it relates to the addiction potential
of prescription drug medication----
Mrs. Ellmers. Yes. Yes.
Mr. Botticelli [continuing]. But the vast majority of
people that, at least, I have talked to, and the data show that
those folks who do have a significant opioid use disorder have
started from a very young age. And if you saw the Philip
Seymour Hoffman story, he actually started with alcohol abuse
at a very young age. So we know that there are prevention and
intervention opportunities that we can have along the way to
really make sure that we are identifying people early in their
disease progression, and then we are intervening in this issue.
Mrs. Ellmers. Yes.
Mr. Botticelli. The other piece that you talked about, and
again, I think it still warrants further work, is what about
the progression from prescription drug use to heroin addiction.
Mrs. Ellmers. Yes.
Mr. Botticelli. Clearly, we know that it is a progressive
disease, and people, left untreated, will often progress to
more significantly harmful use patterns, but we also know that
price plays a role, as the DEA mentioned, in terms of the
progression. So we know that there are multiple factors that
really affect peoples' progression, not only in terms of
overall development of a substance use disorder, but from
prescription medication to heroin.
Mrs. Ellmers. Yes. Yes. Dr. Volkow?
Dr. Volkow. Yes, and the questions you ask intrigue many
scientists, and it is called--has led to the term of gateway--
--
Mrs. Ellmers. Right.
Dr. Volkow [continuing]. Hypothesis because all of the
epidemiological studies have repeated corroborated that most
individuals that become addicted to illicit substances started
with nicotine or alcohol, then transition into marijuana and
then the other drugs. So the question is that just because it
is more accessible that you start with nicotine or alcohol----
Mrs. Ellmers. Yes.
Dr. Volkow [continuing]. Or could it be that these drugs,
including nicotine, alcohol, and marijuana, are changing your
brain in such a way that it makes it more receptive to the
addictiveness of drugs.
Mrs. Ellmers. Yes.
Dr. Volkow. And there is data now from genetic studies and
from studies in animals that suggest, at least for the case of
nicotine and alcohol, and also marijuana, that it is changing
the sensitivity of the brain reward sequence in a way that
primes you----
Mrs. Ellmers. Yes.
Dr. Volkow [continuing]. To the addictiveness of these
other drugs. And in the case of prescription opioids, that is
also what they are observing, that most of the individuals that
end up addicted to prescription opioids had a history of
nicotine addiction earlier, or had started abusing alcohol.
Mrs. Ellmers. Yes. Thank you.
My last question is for Mr. Rannazzisi. Obviously, your
agency is working with many other agencies on this issue, and I
am going to ask you a question that really falls under the FDA,
but from your opinion, in the work that you are doing, do you
believe that some of the prescription drugs, the deterrent
formulas such as, you know, for Oxycontin, some of the
deterrent formulas, will that make a difference and is it
feasible that if we take this approach, that that is going to
help on the wide and broad scope that you have outlined if we
are using these deterrent forms?
Mr. Rannazzisi. Absolutely. The abuse deterrent
formulations will make a difference. But those drugs will still
be abused----
Mrs. Ellmers. Yes.
Mr. Rannazzisi [continuing]. Orally with a potentiator,
like a muscle relaxer, or a Benzo, but in the end, it is going
to stop them from crushing and snorting, or crushing and
injecting.
Mrs. Ellmers. Yes.
Mr. Rannazzisi. And we know that when you crush and inject,
or crush and snort, you are raising the risk----
Mrs. Ellmers. Yes.
Mr. Rannazzisi [continuing]. Of overdose and death----
Mrs. Ellmers. Yes. Yes.
Mr. Rannazzisi [continuing]. Just in that method of
delivery. So, yes, do I think it is important? Absolutely, it
is important. Look at what happened with the Oxycontin product,
when it went from the OC to OP, you could bang that tablet with
a hammer and it is not going to break.
Mrs. Ellmers. Yes.
Mr. Rannazzisi. It balls up in your nose when you try to
snort it. It is crazy----
Mrs. Ellmers. Yes.
Mr. Rannazzisi [continuing]. That, if you try to abuse that
drug, but what do we see everybody doing? Immediately, they
started moving to the Oxymorphone product----
Mrs. Ellmers. Yes.
Mr. Rannazzisi [continuing]. Or the immediate release Oxy
30s. OK, so they are adapting.
Mrs. Ellmers. Yes.
Mr. Rannazzisi. If we could figure a way to get an abuse
deterrent formulation across the board, then we are going to
see some significant results----
Mrs. Ellmers. Thank you.
Mr. Rannazzisi [continuing]. Absolutely.
Mrs. Ellmers. Thank you so much for your answers, and your
insight on this issue.
And, Mr. Chairman, I yield back the remainder of my time.
Mr. Burgess. Gentlelady yields back.
The gentleman from Kentucky, Mr. Yarmuth, recognized 5
minutes for your questions please.
Mr. Yarmuth. Thank you very much, Mr. Chairman. And I thank
the panel as well for the testimony, and for what is obviously
a very committed effort across the spectrum of government to
deal with this problem. I am glad to know that, I shouldn't say
glad, but it is somewhat reassuring to know that this is not
just a Kentucky problem. Certainly, in my travels in my
district and around the state, and talking with law enforcement
and with mental health professionals, and everyone who is
involved in this area, we have a huge problem in Kentucky.
During the first 3 quarters of 2013 there were at least 170
Kentuckians who died from heroin overdoses, and that was 41
more people who had died the entire previous year, and is
actually a 200-plus percent increase since 2011. So we have a
problem that is there and growing.
And one of the young people who died was the nephew of a
Kentucky state representative, Joni Jenkins, a good friend of
mine and a great representative. Her nephew, Wes, they
suspected, began with prescription drugs and then moved to
heroin because of expense. He died in May of 2013. And she told
her story in the Louisville Courier-Journal, and I would like
to read one of the things she said because it prompts a
question. She said, for an entire year, our family kept the
addiction private. They were well aware of it, he had been in
and out of treatment and they were working with him, but they
kept it private so Wes would not suffer the social stigma of
being a drug addict. I now know that there is a terrible shame
attached to this illness, but we have to break through the
silence to find a cure. And she said, I also know that I will
search for answers the rest of my life for that.
Is this a problem that you have seen? You are nodding your
head, Mr. Botticelli, so respond to that, that much of the the
access to treatment or the willingness to treatment is deterred
because of a social stigma?
Mr. Botticelli. I have--and many of us have heard that
story countless times from parents. Many of us were just in
Atlanta with a conference sponsored by Chairman Rogers. And we
hear that story repeatedly, and I think our collective efforts
have really been to raise the visibility of ensuring that
people know that addiction is a disease, and this is not about
shame, this is not about guilt. We know that one of the reasons
why people don't seek treatment, and why parents don't ask for
help, is because of the shame and embarrassment that is related
to that. And so part of what I think all of our Federal
partners are doing is how do we raise the understanding and
visibility, and, quite honestly, the compassionate treatment of
people with addiction--of addictive disorders into this work.
And I think that we are seeing, quite honestly, a movement in
terms of--like we did with other disorders that were shameful
and stigmatized----
Mr. Yarmuth. Yes.
Mr. Botticelli [continuing]. That we have to elevate the
voice of parents and people in recovery so that we do know that
hope is possible, and that it would be easier for them to come
forward and ask for help, but unfortunately, we have heard that
story way too many times from----
Mr. Yarmuth. Yes.
Mr. Botticelli [continuing]. From parents and people who
are affected.
Mr. Yarmuth. Have you come up with any great answers? I
mean what can we do to help that just as individual members? We
do span the country anyway.
Mr. Botticelli. Yes. I think there are a couple of things
that we are doing. A lot of our work at the Office of National
Drug Control Policy, we actually established an Office of
Recovery to really promote the fact--we are looking at the
development of recovery support services, so that people in the
community can see that recovery is possible. I think we have
been promoting--those of us who are in recovery, talking very
publicly about the fact that we are in recovery, because it
shows to other people that this is not just about death and
destruction, that there really is hope on the other side of
this. So I think all of us play a role in terms of
destigmatizing that.
Just having these hearings really shows the fact that we
have leadership in this country who are concerned about this,
and it is not a shame. This is not a moral choice, this is not
a moral failing, this is about a disease, and we have to deal
with it from a public health perspective.
Mr. Yarmuth. Yes.
Mr. Botticelli. So I really appreciate your acknowledgement
of that--those challenges.
Mr. Yarmuth. Well, it seems to me that much of this problem
involves education. I assume that when these young people, or
whether it is young or not, but predominantly young people
begin on prescription drugs, they have no idea that this is the
course that they could likely be on. And I don't know whether
that is a school issue, a PTA issue, what it is, but it seems
to me like information is one of the greatest avenues for
combatting this problem.
Well, anyway, Mr. Chairman, I would request unanimous
consent that this OpEd that I mentioned from Joni Jenkins be
made a part of the record.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Yarmuth. Thank you, and I yield back.
Mr. Burgess. The gentleman yields back his time.
The Chair now recognizes the gentleman from Ohio, Mr.
Johnson, 5 minutes for your questions please.
Mr. Johnson. Thank you, Mr. Chairman, and I really
appreciate the opportunity to hear from the panel today on this
very, very important issue.
You know, prescription drug and heroin abuse are very
serious--is a very serious epidemic in Ohio, and parts of my
district in eastern and southeastern Ohio are some of the worst
hit.
In 2012, 5 Ohioans died every day from unintentional drug
overdose with opioids, both prescription and heroin, as the
driving factor. Attorney General Mike DeWine identified heroin
as contributing to as many as 11 fatal overdoses a week. It is
a major public health crisis. However, prescription opioids
continue to be the lead contributor to fatal overdoses in the
state. In 2012, for example, an average of 67 doses of opioids
were dispensed for every Ohio resident.
Law makers, nonprofit organizations, medical, industry
leaders, communities and parents across the state have been
working to coordinate their response to this epidemic, but in a
corner of Ohio that shares borders with 3 other states,
communities are struggling to get drug abuse under control.
Individuals identified as abusing in one state may cross state
lines to escape detection and abuse in another. A nonintegrated
system also makes it harder to identify prescribing providers
and pill mills.
So for all of you on the panel, anyone that wants to try
and respond to this, I realize that states are largely in
charge of implementing their own prescription drug monitoring
programs, but in multistate areas like I serve, the importance
of working together to curb abuse cannot be emphasized enough.
So what is being done at the federal level to encourage states
to share information compiled by their respective PDMPs?
Mr. Botticelli. Thank you, Congressman, and as you have
articulated, both the establishment of vibrant prescription
drug monitoring programs, and, quite honestly, the interstate
interoperability of those programs, has been key for much of
the work that we have been doing on the Federal level. So, we
are happy that in 2006 we only had about 20 operable
prescription drug monitoring programs in the United States, and
now we have 48 that are operable, one in the process and
unfortunately, one state that doesn't have a prescription drug
monitoring program. And as part of this strategy, we have been
working with the Bureau of Justice Assistance and the Boards of
Pharmacy to really look at interstate operability so that those
states that share a border can make sure that they are sharing
data. So now we have 20 states that are able to share
information across borders, and clearly, we have a goal of
making sure that all of these programs share data among
particularly neighboring states.
Mr. Johnson. Yes, I will share with you that, as a 30-year
IT professional myself, I can tell you that architecture and
data standardization, interface standards, those are very, very
critical components. If you don't know where you are going, any
road will get you there. And it is one thing to have a
monitoring system, it is quite something else to have a
monitoring system that adheres to standards so that it can be
effectively used.
How do we make the nationwide PDMP system more effective,
and what still needs to be done to fully achieve a fully-
integrated network?
Dr. Sosin. Congressman Johnson, thank you for your
question. Clearly, the PDMP and the ability to achieve
successful, effective PDMPs is critical to the law enforcement
side, the public health side as well, the clinical side as
well. And as Mr. Botticelli commented, we are making progress,
meaning that we are better understanding the components of
these PDMPs, and what it is that needs to be shared and how to
share them. The work that you all are doing in raising
visibility, that governors and mayors are doing, saying that
this is an issue that they are going to address, also allows
this opportunity to set the standards for what we need to share
and how we will share that information across borders.
The CDC, working with the FDA and the Bureau of Justice
Assistance, has been funding at Brandeis, the prescription
behavioral surveillance system, which takes from 20 states the
PDMP data they have, to better understand what these factors
are that increase the success of PDMP's.
Mr. Johnson. Let me get to one more quick question. I have
to move quickly.
How can we shift drug abuse prevention efforts from the
collection of silo data like we are talking about, to a system
in which this information isn't lost every time an individual
realizes that they are being tracked, and takes evasive
measures like leaving a health plan, for example, because not
only do you have working across state lines, but an abuser that
goes from one health plan to another can also hide. So how do
we solve that problem?
Mr. Botticelli. And some of my colleagues can add on to
this, but part of what we have been really trying to focus on
is make sure that we are treating and integrating substance use
issues as part of mainstream healthcare, of really looking at
things like making sure that people are getting screened and
intervened as part of their overall health plan so that, you
know, for a very, very long time, we have had two systems of
care in the United States. We have had medical care over here
and behavioral healthcare over here, and that we haven't
necessarily really looked at how we make sure that we are
treating substance use disorders as a medical condition.
So part of our goal is more thorough integration of mental
health and substance use services within our primary care
settings----
Mr. Johnson. Sure.
Mr. Botticelli [continuing]. Because it is really important
that we not see these as two separate issues.
Mr. Johnson. Yes.
Mr. Chairman, I have many, many more questions. Obviously,
this is a complex and sensitive issue for many Americans, but I
have run out of time so I yield back. Thank you.
Mr. Burgess. The Chair thanks the gentleman. The gentleman
yields back his time.
The Chair recognizes the gentlelady from Florida, Ms.
Castor, 5 minutes for your questions please.
Ms. Castor. Thank you, Mr. Chairman, and thank you to the
panel very much.
This hearing is really hitting home for me today because
yesterday I learned that the death of a friend last month was
tied to her long-term opioid addiction. Her sister sent me an
email, I got it just yesterday, and she committed suicide, and
her sister said because of her long-term addiction. So she left
a daughter and a husband and an entire family, and the sister
is asking please do more. So I hope we can all come together to
tackle this. It is causing so much pain for so many families.
And the State of Florida has really been at the heart of
the problem. And still in Florida, they say that every 7 to 8--
every--I can't believe it, 7 to 8 minutes, someone overdoses in
the State of Florida. I am also hearing from my local
hospitals. They have had to add rooms in the NICU units of
hospitals because of babies being born addicted, and these
babies typically will cost $1 million to take care of, and they
are in the hospital for a month. So we had better invest in
prevention or else we are going to be spending a lot on the
outside.
So, Mr. Rannazzisi, Florida--the general talking points
are, well, Florida has improved. There was a huge law
enforcement crackdown. We have adopted a prescription drug
tracking system, the PDMP. The problem is that doctors are not
using it. The last statistics I saw, only 3.5 percent of all
prescriptions being written are being checked on that database.
What is your view right now in Florida? Have we made
progress? What is left to do?
Mr. Rannazzisi. I think under the leadership of Attorney
General Bondi and law enforcement leaders down in Florida, yes,
we have made progress, absolutely. The problem is, again, we
are overwhelmed by the numbers. There are so many people down
there in Florida. We actually have cases where Florida rogue
pain clinic operators were funding clinics in northern states,
so when when the heat is on them, they are going to move into
another state.
I think that we are making progress, but again, it is going
to take time. Now, the PDMP issue, I would love to see mandated
PDMP use. The National Association of Boards of Pharmacy have
gone out of their way to ensure that there is interoperability
and interconnectivity between the PDMP's. I think they have 25
states that are already connected, and they have done a
phenomenal job, but if no one is looking at that PDMP, or very
few are looking at that PDMP, it is not going to help.
Ms. Castor. So do you agree that the local law enforcement
efforts--what I see on the ground in my community, in the Tampa
Bay area, we used to have these long lines with cars from out
of state, people waiting outside in the alley for these pill
mills to open up. You don't really see that anymore, but with
these statistics on the rate of deaths from overdose, something
else is happening. We are not really making a dent there. Has
it shifted to the internet, are they going out of state, is it
both? What is going on?
Mr. Rannazzisi. I think they are moving to more rural areas
where there is less law enforcement presence. I think the
operators understand--I have a great video I would have loved
to have shown you of a clinic, and what happens as soon as the
clinic opens. I think that they are adapting. The clinic owners
are adapting very well, and they are one step ahead of us right
now, but in the end, local law enforcement is doing a
phenomenal job, and they are moving people out of the Tampa Bay
area and out of the 3-county area, but it is still there----
Ms. Castor. Yes.
Mr. Rannazzisi [continuing]. It is just moving to more
rural areas where they can't address the problem as quickly.
Ms. Castor. So in this very sad e-mail from my friend that
I got yesterday, she said she has read now about the FDA
approval of Zohydro, pure Hydrocodone, non-tamper resistant, 10
times stronger than Vicodin, the Vicodin prescription opiate. I
know that the Advisory Committee to FDA had some very serious
concerns with this, yet it has been approved.
Dr. Volkow, could you give me your opinion on whether this
drug should be readily available?
Dr. Volkow. Well, we clearly have a very large number of
opioid medications, and we are overprescribing them. I wouldn't
point my finger at one or the other. I do think that the
feasibility of getting formulations that cannot be diverted is
something that is very powerful, and the FDA should be
commended because it came up--pharmaceuticals can come up with
an indication for a medication that is deterrent proof, and
that is incentivizing to the development of these types of
medications.
Zohydro is Hydrocodone, it is slow delivery over 12 hours,
and it actually does not have Acetaminophen, and because the
way that you have--correctly which is Vicodin, the way that you
have it is combined with Acetaminophen which produces liver
toxicity, which led the FDA to consider if someone needs
Hydrocodone, do you need to give them Acetaminophen, and it was
in that context that they approved it----
Ms. Castor. And----
Dr. Volkow [continuing]. But----
Ms. Castor [continuing]. Could I ask, since my time is
short, Mr. Botticelli, do you agree with the FDA's approval, or
do you have concerns?
Mr. Botticelli. I think the important point, and again, I
don't think the FDA has their own process in terms of how they
approve medications. I would agree that how we continue to make
sure that we have abuse-deterrent formulations is really
important. I also think that this really underscores the
importance of prescribing, and training on prescribing, because
I think the point is that we have many medications that are
open for a potential to abuse, and we want to make sure that
physicians and other prescribers really understand the risks
associated with these drugs.
Ms. Castor. And, Mr. Rannazzisi, local law enforcement has
expressed concern about this new drug on the street because it
is so potent, and because it is likely, if a child takes it, it
could death. What is your view?
Mr. Rannazzisi. Yes, local law enforcement and DEA and our
federal partners have all expressed. We all lived through the
Oxycontin problem back in the '90's into the 2000's, and we
just don't want history to repeat itself. Too many people
passed from the abuse, circumventing that delivery system.
Mr. Burgess. The gentlelady's----
Ms. Castor. And my----
Mr. Burgess [continuing]. Time has expired.
The Chair recognizes the gentleman from Virginia, Mr.
Griffith, 5 minutes for your questions please.
Mr. Griffith. Well, let me pick up there. You are concerned
about this newer drug, and so my question is what do you all
do, and I would ask it of all of you but I start with you, Mr.
Rannazzisi.
Mr. Rannazzisi. Rannazzisi.
Mr. Griffith. Rannazzisi, thank you. And that would be, how
do we do a better job of predicting where we are going to see
spikes and abuse on drugs as they come forward, because some
people say that we should have probably seen the increase in
the prescription drug abuse of opioids and heroin?
Mr. Rannazzisi. Well, we monitor the amount of drug going
into a particular state through our ARCOS system, but in the
end, what we generally see is the drug being abused in the
Appalachian area of the country, and then it spreads out from
there. So when we were looking at Oxycontin, for instance, the
Oxycontin abuse epidemic started in that area, Kentucky,
Tennessee, southern Ohio----
Mr. Griffith. Southwest Virginia.
Mr. Rannazzisi. Yes, southwest Virginia--well, yes,
absolutely. And then spread out. And we believe that pattern is
going to happen again with this new product. It is just a
matter of time. We know that product is now in the pharmacies
and being dispensed, so----
Mr. Griffith. And, now, for the people that we--that you
have identified, I think that one of the other speakers said
abuse-deterrent formulations. Once we know somebody is abusing,
I have always liked the lock-in, where you lock into a pharmacy
and you lock into a doctor, because one of the problems in
southwest Virginia that you mentioned a minute ago is, is that
you can be in West Virginia, Tennessee, Kentucky and North
Carolina all within--no matter where you are in southwest
Virginia, within an hour or 2 hours, you can be in any one of
those states because of the way the geography is, and you can
go from one rural area to another.
So what are we doing on that? Are we looking at that as a
possible means? Dr. Clark, if you want to answer, that is fine.
I am just trying to find answers.
Dr. Clark. Clearly, there is no simple answer, and your
question is a very important one, and this committee is trying
to address it. We are working with the Association of State and
Territorial Health Offices, and the Federation of State Medical
Boards, and the Boards of Pharmacy. We do collect surveillance
data from our household survey and working with our colleagues
in the CDC, so part of the issue is monitoring the movement of
individuals, getting practitioners, whether they are
pharmacists, nurse practitioners or physicians, to monitor what
it is that they are doing. Getting people to access and
actually use the PDMPs, and having interoperability, as was
pointed out. So--and then involving community coalitions,
because, as was pointed out from the representative from
Florida, people know where the places are. And what we need to
do is----
Mr. Griffith. Sure.
Dr. Clark [continuing]. To get community coalitions----
Mr. Griffith. Well, that is why----
Dr. Clark [continuing]. To carry that information.
Mr. Griffith. That is kind of why I like the lock-in
because then, you lock them into a doctor, into a pharmacy, if
you know, now, I don't want to do that to folks who haven't
been identified as having a problem, but once you know they
have a problem, then that gives you a better handle on what
they are doing if you lock them in and that is the only place
they can go. Wouldn't you agree, and I need to hurry because I
have other things I want to ask?
Dr. Clark. That is one strategy that can be employed. So
you want to make sure that if you do that, that they have
access to the resources necessary to be in that----
Mr. Griffith. Sure. And here is the dilemma that we have,
because one of the things that the DEA is--has done, and we
talked about this the last time you were here, is that they are
asking the distributors to, you know, say, OK, don't sell so
much to a pharmacy if that pharmacy looks like they are above
the average, or if you see some sign that they may be abusing.
And I told the story about what happened when I went to my
local pharmacy, and there were two people in there who were
both being told you have to come back next month, which was not
a few--but a few days away, because we used up our allotment.
And I intuited that maybe they only had 1 supplier, and then
that supplier said, he's above average for other people who
have more than 1 supplier. I went back and checked and that is
exactly what is going on. He didn't know that was the problem,
but I said, you only have one supplier, don't you? He said,
yes, I use one distributor. And I think that is the problem.
So we have on the one hand, we want to lock out people who
are abusing it. On the other hand, we want to make sure people
who need it, get it. So I guess what I am saying in the second
matter is, for the rural areas, it may be a problem because
that is less law enforcement, and we recognize that, and why a
lot of my region is in different HIDA designations. At the same
time, you want to make sure people are getting the drugs they
need, and if you are in a rural area, you are a small pharmacy,
you may only be using one distributor. While the DEA doesn't
have a quota, the distributor then is putting a quota on
because, based on other pharmacies, that particular pharmacist
or drugstore is ordering more drugs, but it is because they are
only using the one supplier as opposed to using two or three.
How do we solve that problem? And I think Dr. Volkow wants
in on this.
Dr. Volkow. Yes, I was smiling because the notion is we
have situations where a patient cannot get their medication,
and yet at the same time, the DEA has to collect this massive
amount of pills that people are not using, which tells you we
are overprescribing the number of pills that are necessary.
So coming back to the point that we have been discussing,
we really need to educate the healthcare system on the optimal
way of prescribing them, not just when they need them, but the
number of tablets that you are given. I mean all of us have the
idea, go to the dentist, 2 weeks of opioid prescriptions. I
mean you need one day. So it is the whole notion of educating
the healthcare system, and educating the lay public, and making
the responsibility too of--why do we need to provide so many
pills. And the insurers can get involved into these type of
solutions.
Dr. Clark. And the lock-in approach works as part of a
treatment plan----
Mr. Griffith. That is right.
Dr. Clark [continuing]. With someone who suffers from
chronic pain, the practitioner develops a treatment plan, the
patient agrees, and that actually benefits everyone.
Mr. Griffith. Very good.
Mr. Burgess. The----
Mr. Griffith. I know my time----
Mr. Burgess. The gentleman's time has expired. We will give
an opportunity perhaps for a second round, but I wanted to go
to Mr. Griffith because he has been waiting so long.
Mr, Griffith. Absolutely.
Mr. Scalise. Thank you for that, Mr. Chairman, and for our
panelists for this important discussion. I know in my home
parish of Jefferson, Louisiana, we have seen spikes in increase
of drug-related deaths over the last few years, and each year
it just seems to be going up higher. When I talk to my coroner
in Jefferson, Gerry Cvitanovich, who works very closely in
trying to, of course, they see the end result of it, but they
also try to work on the front end in doing some of the
education that Dr. Clark has talked about and others. They have
seen that heroin is the one that seems to be popping up the
most. I think last year, heroin deaths accounted for a majority
of all the drug-related deaths, over 100 of those. And in my
home parish of Jefferson, like I said, we are seeing this
across the board.
One of the things they do work on is just trying to educate
people in the community. And I know, Dr. Clark, you have talked
about this in your testimony, and alluding to work with not
just pharmacists but others.
What are the different things that you have been doing, and
if you have had success on the education front, especially not
just within the medical community, but within the targeted
populations of those folks that might have the highest
likelihood of being exposed to heroin?
Dr. Clark. Again, one of the things, a comprehensive
strategy becomes critical, and I talked with prevention,
working with community coalitions, so that we have that
message. We have already heard about the issue of chronic pain
management, and people moving from the use of a prescription
opioid to drugs like heroin.
So having good strategies for pain treatment, working with
state health and territorial health officers, federation and
state medical boards, nursing organizations, dental
organizations and even veterinarians, because they, too, have
access to prescription----
Mr. Scalise. Right.
Dr. Clark [continuing]. Opioids, we can address that end of
the agenda, then----
Mr. Scalise. Yes, I want Mr. Rannazzisi----
Dr. Clark [continuing]. Probably----
Mr. Scalise [continuing]. To answer this too because I know
you talked about this in your testimony as well, so if you can
touch on your experiences there.
Mr. Rannazzisi. We never turn down the opportunity to go
out and speak to professional organizations. We have a very
good relationship, or a fine relationship with the National
Association of Boards of Pharmacy, the individual pharmacist
associations, and the medical associations. When they ask us,
we will come out. The Pharmacist Diversion Awareness
Conference, we go out and we have been to 14 states, and
trained over 6,000 pharmacists in their corresponding
responsibility, the trends and trafficking for pharmaceuticals,
to make them aware of what is going on so they know how to deal
with this when a bad prescription comes in and what they are
supposed to do.
We have industry conferences. We bring industry in. October
of last year, we brought the distributors in to talk about what
we are seeing trendwise, and what they need to do as far as
their legal obligations under the Act. We bring the
manufacturers and importers in. In April or May of last year,
we brought them in. And we do this on a regular basis to show
the trends and trafficking. We are out there educating as much
as possible because it is one of the pillars in the
pharmaceutical initiative that the White House is pushing for.
Mr. Scalise. One of the things when you talk to the people
on the ground, our local, whether it is coroners, law
enforcement, there are a lot of different federal programs out
there, and I do want to touch on that GAO report because there
are some concerning issues that they raised that have been
touched on a little bit, but I want to get into a little bit
more, but on that front, when you look at all the grants that
are out there, I know in Louisiana, I think grants come in from
five different departments through thirty different programs
for some of these treatment programs. So there is a lot of
overlap and duplication, but is there a better way maybe to
block grant these, to put them together in a way that would be
more flexible? And maybe, Dr. Clark, you can answer, are we
giving states enough flexibility today and with the duplication
can we do a better job and maybe consolidating those grants in
a way that allow the states to do what they do best, without
having to go through so many different processes, through so
many different agencies, where you have this duplication?
Dr. Clark. Well, clearly, we have to work with states and
their discretion in how to prioritize what it is that they view
as important epidemiologically in their jurisdiction. And so we
have supported the use of block grant funds to the discretion
of the states, and worked with both the individual state
authorities and the national organizations associated with
that.
We are also working with recovery-oriented organizations so
that we have peers, people who are recovering from substance
use disorders to help speak up and carry out the message,
working with community coalitions and others because, indeed,
they can tell a better story than professionals or regulators,
et cetera. So----
Mr. Scalise. OK, and----
Dr. Clark [continuing]. The----
Mr. Scalise [continuing]. And let me apologize, my time is
about to go, I do want to at least ask for the record, if I can
get this information on the GAO report, because it did
identify, you have, what, 15 different federal agencies, 76
different federal programs that all have abuse prevention or
treatment programs, and they also identified overlap of 59 of
the 76 programs. And so I think Dr. Gingrey had earlier asked
Mr. Botticelli and Dr. Clark to talk about what your agencies
are doing to address that overlap, those problems that were
identified in the GAO report.
If, Dr. Sosin, I am sorry, Dr. Volkow and Mr. Rannazzisi
can also get me their information to--just to show what you all
are doing to try to address the overlap problems that were
raised in that GAO report.
And with that, I will----
Mr. Burgess. Well, the gentleman's time has expired. I
think that information will be generally interesting to the
committee, so if the committee staff will provide that
information to the committee.
Mr. Scalise. Would you all be OK with getting that to the
committee? Thank you.
Mr. Burgess. And the Chair would recognize the gentleman
from Texas, Mr. Green, 5 minutes for your questions please.
Mr. Green. Thank you, Mr. Chairman. And I thank the O&I
Committee for having this hearing.
Prescription drug abuse is a real growing and public health
threat that must be addressed. The consequences of abuse and
addiction to opioids such as prescription pain relievers and
heroin has a devastating effect on our communities. We need a
comprehensive solution that protects public health, preserves
patient access to the needed therapies, and improved access to
treatment.
Last week, an article was published in the New England
Journal of Medicine discussing the Department of Health and
Human Services' efforts to address the prescription opioid
overdose epidemic, including improving access to the addiction
treatment services.
Dr. Volkow, you were one of the authors of this article,
and, Dr. Clark and Dr. Sosin, the heads of your respective
agencies also authored this article. The article makes clear
that the treatment of addiction to prescription drugs and other
opioids with proven approaches like Methadone and other
medication assisted therapy is of crucial importance. It
describes the importance of the Affordable Care Act in
increasing access to care for many Americans, including those
who are struggling with addiction disorders.
Dr. Volkow, can you elaborate on how the ACA builds on the
Mental Health Parity and Addiction Equity Act, and improve on
insurance coverage for people who are addicted to prescription
drugs, heroin or other substances?
Dr. Volkow. Yes, the problem is that, as I mentioned in my
testimony, is that less than \1/3\ of patients that require,
that could benefit from opioid medications, are getting them
for the treatment of their addiction. And these reflect, among
other things, the fact that many of the people that are
addicted to drugs do not have an insurance, and rely on the
state funding to get their treatment. And as a result of that,
we have removed the healthcare system for a position there--
where they could not just act in preventing substance use
disorders, but on treating them. The healthcare act, by
providing insurance to those that currently don't have it, will
give them the opportunity to be treated in the healthcare
system for substance use disorders, as well as, in those
instances where the addiction has not occurred, for the
healthcare system to intervene in prevention. So that is why it
is so important.
Mr. Green. Dr. Clark, do you agree with that?
Dr. Clark. Indeed. When people who present for treatment
can't get treatment, are asked why they couldn't get treatment,
the largest reason is cost and access to treatment.
Mr. Green. OK, thank you. I understand the ACA provision
creates an optional Medicaid state plan, benefit for states to
establish health homes for the coordination of beneficiaries
with chronic conditions, has also supported some states in
their effort to address the drug abuse.
Dr. Clark, can you elaborate on how the Health Home Program
is beneficial in tackling the problem of abuse?
Dr. Clark. Well, we have actually, with regard to opioids,
we have got several jurisdictions that are looking at health
homes as a way of dealing with opioids. So in Vermont, one
jurisdiction, I think, Rhode Island, I will have to clarify
that, is also taking that approach. Comprehensive services
being offered where a person's care is adequately monitored
offers us an opportunity to reduce some of the complexities
associated with opioid misuse.
Mr. Green. Thank you. It is clear from the comments the
Affordable Care Act makes it possible for many people with
substance use disorders, whether it is addiction to
prescription drugs, heroin, or other substances, to access the
treatment they so desperately need.
Mr. Chairman, I know we have had our differences over the
Affordable Care Act, but I would hope we all share the goal of
providing more robust treatment to those who are working to
overcome this addiction.
And I yield back my time.
Mr. Burgess [presiding]. The gentleman yields back. Our
discussion with the Affordable Care Act will continue at a
later date.
Mr. Green. I am sure it will.
Mr. Burgess. We have now I think heard from all members who
wanted to ask a question. I would ask unanimous consent that a
follow-up question be allowed for those of us who remain.
Mr. Green. I don't have any problem with that. I can't
stay, but----
Mr. Burgess. Very well, but I wanted to get that unanimous
consent agreed to before you left, so it is not just on my
shoulders.
Mr. Green. I trust the Chairman.
Mr. Burgess. Mr. Griffith, I interrupted you before. Would
you like to follow up on your line of questioning?
Mr. Griffith. Well, I would just like to give an
opportunity, Mr.----
Mr. Rannazzisi. Rannazzisi.
Mr. Griffith [continuing]. Rannazzisi.
Mr. Rannazzisi. Yes.
Mr. Griffith. Thank you. I am sorry I have such a hard time
with that this morning. But Mr. Rannazzisi was about to comment
on the dilemma that we have with the small rural pharmacists,
or pharmacy, that has one distributor.
Mr. Rannazzisi. Yes, and I want to thank you for clarifying
that DEA has not set a quota downstream for the distributors.
The distributors are working through their issues regarding
due diligence to determine if there is a problem pharmacy or if
it is not a problem pharmacy. I think that the rural pharmacies
present a specific problem because they do need to get
medication to their patients, and they need that downstream
supply. We are hoping that the distributors are on site,
looking at their operations before they completely cut off the
distributor, or limit the pharmacy, but again, that is a
business practice and, unfortunately, I have no control over
their business practices.
Mr. Griffith. Well, and I would just say it is because of
the concerns and I am sure some memos have been put out by the
DEA, we are all trying to do the right thing, that has caused
the distributor to be concerned, and maybe if there could be
some acknowledgement from the DEA to the distributors, hey,
keep an eye out if it is rogue, but if it is just you are
looking at, you know, this pharmacy is more than another
pharmacy, find out if they have just one distributor because
that makes a huge difference in whether or not they are truly
distributing more of the opioids than somebody else. And if you
all could do that, that would be greatly appreciated.
Mr. Burgess. The gentleman yields back. I thank the
gentleman for his follow-up.
Dr. Volkow, you made a statement that was really fairly
provocative a few moments ago, and I just wanted to follow up
on it a little bit with you when you were discussing the effect
of nicotine, alcohol on developing--I guess you were talking
about developing brains and then you added the--with the
addition of marijuana, and I ask you not to say anything about
the rightness or wrongness of the public policy, but as you
know, this nation is right now engaged in a significant
experiment where some states have legalized marijuana. Are you
all studying that and the effect of this decriminalization in
some states? Are we prepared for what might happen next?
Dr. Volkow. Yes, definitely. I know, unfortunately, it is
one of those experimental situations that is happening, whether
we like it or not. So what we have done is provided, identified
the grantees, the researchers, in those communities where there
has been legalization for recreational or medical purposes to
actually give them supplemental money so that they can look at
the consequences of these changes in policy, in the education
of systems, in accidents, in emergency room admissions, in
productivity in the workforce. We need to have evidence that
can then--hopefully can guide policy, as opposed to doing
policy in darkness on the beliefs of people, and what--since
you brought up the issue, to one of the things that is also a
concern as discussing the prescription, people are using
prescriptions because they feel that are prescribed by
physicians, they cannot be so harmful.
The notion that marijuana has so-called medical purposes is
also changing the perception of this drug cannot be so harmful
if it has medicinal properties. And the whole perception of
risk is changing, which, again, has opened the willingness of
young people to take marijuana and to consume it regularly.
Mr. Burgess. Well, I do hope that you are monitoring the
situation, since society has provided you the experimental
situation. I also hope that you are preparing to deal with what
the downstream effects are from this rather bold social
experiment that some of the states are undertaking right now.
And I hope that is more than just sending more money to those
states. I hope that it is something that you are--that
oversight is happening at your level, that there will be a
national monitoring of this.
Dr. Volkow. The way that we oversee research protocol is
very, very rigorous. If the scientist is not producing or the
methodology is not adequate, we do not fund them.
Mr. Burgess. Just speaking of downstream effects, there is
also the issue, and it has been brought up several times this
morning, and any of you feel free to comment on this, the issue
of, of course, the device by which the drug is administered,
and then the possibility for exposure to Hepatitis B or C, or
HIV. From a public health perspective, are we preparing
ourselves for any differences in the incidence of these
illnesses as a consequence of the delivery device?
Mr. Botticelli. I will start on that. One of the main
concerns of HHS has been, obviously, the increase in viral
hepatitis and hepatitis C among the very young cohort of
injection drug users. So we have been working in concert with
the Health and Human Services who has put forth actually an
action plan to diminish viral hepatitis, and clearly, there is
a lot of overlap in terms of the issues that we are talking
about here. So this is obviously a significant public health
concern, so we want to make sure that we are dealing with this
in a concerted way.
Mr. Burgess. Yes, and, of course, the good news right now
is Hepatitis C is one of those things that looks very well like
there may be a cure that is not just on the horizon but is
here. The only problem is it is very expensive. And my
differences with Mr. Green over the Affordable Care Act aside,
ultimately though, someone has to pay for that, so I hope we
are doing the necessary--I hope we are monitoring and doing the
necessary preventive things to keep that in check, and to
prevent the disease, rather than just simply now being able to
cure it with a very expensive therapy that, thankfully, is
available.
Mr. Botticelli, did you have some additional observations
on the issue of the states that are legalizing marijuana?
Mr. Botticelli. I do, and what I wanted you to know is that
in addition to the additional NIDA grants that are out there,
our office has actually convened a group of Federal partners to
look at the eight criteria that the Department of Justice has
laid out for Colorado and Washington, and are really committed
to gathering data on the Federal, state and local level,
looking at what is the impact in terms of legalization in
Colorado and Washington have on both the public health and
public safety consequences that we have. So in addition to some
of the public health-related work that Dr. Volkow has funded,
we are also looking at what are the public safety consequences,
things like increase in drugged driving, interstate
transportation of marijuana from Colorado to other states. So
our office has really been committed in terms of ensuring that
we have good public health and public safety data to monitor
what is happening in Colorado and Washington.
Mr. Burgess. And, Mr. Rannazzisi, I would assume that your
agency is participating in that as well?
Mr. Rannazzisi. It still is a Schedule I controlled
substance. We are still doing investigations concerning
marijuana downstream.
Mr. Burgess. And are you monitoring the downstream effects
in neighboring states, in the incidences--as Mr. Botticelli
talked about, the incidence of driving while impaired, the
incidence of even just crime, are you compiling those
statistics so they will be available to policymakers in
subsequent hearings?
Mr. Rannazzisi. We are talking to our state and local
counterparts in all of the surrounding states, and we are
gathering information. I don't know how all-inclusive that
information is because, quite frankly--some of the state and
locals are not keeping that type of information, but we are
keeping tabs with our state and locals on what is going on
within their states.
Mr. Burgess. Very well.
Mr. Griffith. Mr. Chairman.
Mr. Burgess. Yes, the Chair recognizes the gentleman from
Virginia.
Mr. Griffith. I would be remiss, since we have taken on
marijuana, not to mention that I have just introduced a Bill to
legalize the use of marijuana in medicinal circumstances, akin
to the Virginia plan that was passed in 1979, that requires a
doctor's prescription, thus, changing the scheduling. The Bill
actually calls for the changing of the scheduling. The DEA is
in a tough spot. Some of these states are doing it, but it is
still a Schedule I, which means that the DEA has a hard time
collecting the data that you just asked for without stumbling
across felons that they are not prosecuting. So they are in a
catch 22. I think it is much better to have doctors and
pharmacists, and the regular system working, because then you
get real data for your scientists to look at and see if it is
effective, as they designed it to be.
So the Bill doesn't go as far as Colorado or Washington
might want it, or the Crazy California Plan as I often call it,
but it allows real doctors with real pharmacists and real
distributors, controlled by and under the laws of the United
States, to use true marijuana if it can be used in a real way
medicinally.
Mr. Burgess. Very good. The gentleman yields back.
I am all for giving doctors more power.
That actually concludes all of the questions that we have
from members. I neglected to mention at the start of the
hearing, ask unanimous consent that members' written opening
statements be introduced into the record. Without objection,
the documents will be entered into the record.
In conclusion, I would like to thank all of our witnesses.
I will thank the member that have participated in today's
hearing. I will remind members they have 10 business days to
submit questions for the record, and I will ask the witnesses
to all agree to respond promptly to the questions submitted in
writing.
With that, the subcommittee is adjourned. Thank you for
your attendance today.
[Whereupon, at 12:06 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Tim Murphy
Three months ago, the country was shocked and saddened by
the death of actor Philip Seymour Hoffman. Like many who battle
addiction, Mr. Hoffman struggled to stay clean as he alternated
between pain pills and heroin. His story is far too common.
Opiate addiction surrounds us--from cities, rural towns, and
affluent suburbs--and it breaks our heart to see so many
families torn apart by abuse of drugs that are both legal and
illegal.
My own district has suffered terribly from opiate
overdoses. Last year, more than 90 people in Westmoreland
County lost their lives to prescription drug and heroin abuse.
That was four times the number of overdose deaths in the county
compared to a decade ago. Allegheny County saw more than 20
deaths linked to fentanyl-laced heroin this past January.
Heroin-related deaths have increased 400 percent in
Cleveland. Vermont Governor Peter Shumlin dedicated his entire
annual ``State of the State'' address to what he called the
``fullblown heroin crisis'' facing his state. Kentucky, West
Virginia, New Mexico, and other states are also experiencing
rising rates of prescription drug overdoses and heroin abuse.
Here's the awful truth about this public health crisis:
prescription painkillers are involved in more overdose deaths
than cocaine and heroin combined. Prescription drug abuse kills
more than 16,000 people a year.
While most prescription drug abusers do not go on to abuse
heroin, data from the White House Office of National Drug
Control Policy (ONDCP) and the Substance Abuse and Mental
Health Services Administration (SAMHSA) indicates that 81
percent of people who started using heroin in 2008 to 2010 had
previously abused prescription drugs.
As authorities have cracked down on access to legal pain
killers in the last five years, heroin use has risen by an
astonishing 79 percent.
Certainly, there is a law enforcement aspect to solving
this problem and stopping the bad actors who illegally
distribute prescription drugs or traffic heroin. But the other
part of the equation is treating addiction to prescription
drugs and heroin--and preventing deaths.
The purpose of today's hearing is to examine the federal
public health response to prescription drug and heroin abuse.
Our oversight has revealed that this is a complex problem. For
example, 40 percent of those who abuse drugs have an underlying
mental illness. Treating their addiction successfully
necessarily means that the underlying mental illness must be
successfully diagnosed and treated.
But just as when someone has a mental illness, those who
are battling addiction are unlikely to get effective treatment,
too. More than 90 percent of persons with a substance abuse
disorder won't get medical care. And of those who are enough to
access care, 90 percent of them will not get evidence-based
treatment.
There are effective treatments available, but too often the
substance abuse debate is divided between those who adhere to
the abstinence or 12-step model, and those who promote medical
assistance therapies. These groups must come together and find
a solution because thousands of lives are at stake.
As the testimony of Mr. Botticelli, the Acting Director of
the Office of National Drug Control Policy, states, substance
abuse is a ``progressive disease.'' Those who suffer from
addiction often start at a young age, with alcohol and
marijuana, and then move to other drugs like opioids. In
examining opioid abuse, we must also consider the factors that
lead people to abuse--and how federal programs are addressing
them.
Prescribing practices are an issue. Roughly 20% of
prescribers prescribe 80% of all prescription painkillers.
Those suffering from chronic and debilitating pain need access
to opiates, but we also need to make sure those individuals who
develop an addiction are referred to treatment. Right now, too
many states lack a robust prescription drug monitoring program
that would help physicians and emergency rooms keep tabs on
patients receiving powerful opiates.
Educating doctors and pharmacies about appropriate
prescribing will address one part of the problem--but addicts
also get these drugs through illegal channels, such as rogue
Internet pharmacies, off the street, and even from the medicine
cabinets of family members and friends.
The federal government is devoting significant resources to
drug control programs--over $25 billion annually, of which
about $10 billion goes toward drug abuse prevention and
treatment programs across 19 federal agencies. With 19 agencies
having a hand in over 70 drug control programs, we have to ask,
`is our current approach working and what can we do better?'
Oversight by the federal agencies is also an important issue,
as significant funding is block granted to states for treatment
programs. How are you confident that we are funding treatments
with the best chances of success in preventing and treating
opiate abuse?
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