[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
TREATING ADDICTION AS A DISEASE: THE PROMISE OF MEDICATION-ASSISTED
RECOVERY
=======================================================================
HEARING
before the
SUBCOMMITTEE ON DOMESTIC POLICY
of the
COMMITTEE ON OVERSIGHT
AND GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
JUNE 23, 2010
__________
Serial No. 111-140
__________
Printed for the use of the Committee on Oversight and Government Reform
Available via the World Wide Web: http://www.fdsys.gov
http://www.oversight.house.gov
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COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM
EDOLPHUS TOWNS, New York, Chairman
PAUL E. KANJORSKI, Pennsylvania DARRELL E. ISSA, California
CAROLYN B. MALONEY, New York DAN BURTON, Indiana
ELIJAH E. CUMMINGS, Maryland JOHN L. MICA, Florida
DENNIS J. KUCINICH, Ohio JOHN J. DUNCAN, Jr., Tennessee
JOHN F. TIERNEY, Massachusetts MICHAEL R. TURNER, Ohio
WM. LACY CLAY, Missouri LYNN A. WESTMORELAND, Georgia
DIANE E. WATSON, California PATRICK T. McHENRY, North Carolina
STEPHEN F. LYNCH, Massachusetts BRIAN P. BILBRAY, California
JIM COOPER, Tennessee JIM JORDAN, Ohio
GERALD E. CONNOLLY, Virginia JEFF FLAKE, Arizona
MIKE QUIGLEY, Illinois JEFF FORTENBERRY, Nebraska
MARCY KAPTUR, Ohio JASON CHAFFETZ, Utah
ELEANOR HOLMES NORTON, District of AARON SCHOCK, Illinois
Columbia BLAINE LUETKEMEYER, Missouri
PATRICK J. KENNEDY, Rhode Island ANH ``JOSEPH'' CAO, Louisiana
DANNY K. DAVIS, Illinois BILL SHUSTER, Pennsylvania
CHRIS VAN HOLLEN, Maryland
HENRY CUELLAR, Texas
PAUL W. HODES, New Hampshire
CHRISTOPHER S. MURPHY, Connecticut
PETER WELCH, Vermont
BILL FOSTER, Illinois
JACKIE SPEIER, California
STEVE DRIEHAUS, Ohio
JUDY CHU, California
Ron Stroman, Staff Director
Michael McCarthy, Deputy Staff Director
Carla Hultberg, Chief Clerk
Larry Brady, Minority Staff Director
Subcommittee on Domestic Policy
DENNIS J. KUCINICH, Ohio, Chairman
ELIJAH E. CUMMINGS, Maryland JIM JORDAN, Ohio
JOHN F. TIERNEY, Massachusetts DAN BURTON, Indiana
DIANE E. WATSON, California MICHAEL R. TURNER, Ohio
JIM COOPER, Tennessee JEFF FORTENBERRY, Nebraska
PATRICK J. KENNEDY, Rhode Island AARON SCHOCK, Illinois
PETER WELCH, Vermont BILL SHUSTER, Pennsylvania
BILL FOSTER, Illinois
MARCY KAPTUR, Ohio
Jaron R. Bourke, Staff Director
C O N T E N T S
----------
Page
Hearing held on June 23, 2010.................................... 1
Statement of:
Mavromatis, Mike, member, Addictionsurvivors.org; Jeffrey
Samet, M.D., MA, MPH, professor of medicine, Boston
University School of Medicine; Gregory C. Warren, MA, MBA,
president and CEO, Baltimore Substance Abuse Systems, Inc.;
Orman Hall, executive director, Fairfield County Ohio
Alcohol Drug Abuse Mental Health Board; Charles O'Keeffe,
professor, Departments of Pharmacology & Toxicology/
Epidemiology & Community Health, Institute for Drug and
Alcohol Studies, VCU School of Medicine; and Richard F.
Pops, chairman, president, and chief executive officer,
Alkermes, Inc.............................................. 50
Hall, Orman.............................................. 75
Mavromatis, Mike......................................... 50
O'Keeffe, Charles........................................ 83
Pops, Richard F.......................................... 100
Samet, Jeffrey........................................... 60
Warren, Gregory C........................................ 67
McLellan, A. Thomas, Ph.D., Deputy Director, Office of
National Drug Control Policy; and Nora D. Volkow, M.D.,
Director, National Institute on Drug Abuse................. 7
McLellan, A. Thomas...................................... 7
Volkow, Nora D........................................... 18
Letters, statements, etc., submitted for the record by:
Hall, Orman, executive director, Fairfield County Ohio
Alcohol Drug Abuse Mental Health Board, prepared statement
of......................................................... 77
Kucinich, Hon. Dennis J., a Representative in Congress from
the State of Ohio, prepared statement of................... 4
Mavromatis, Mike, member, Addictionsurvivors.org, prepared
statement of............................................... 53
McLellan, A. Thomas, Ph.D., Deputy Director, Office of
National Drug Control Policy, prepared statement of........ 10
O'Keeffe, Charles, professor, Departments of Pharmacology &
Toxicology/Epidemiology & Community Health, Institute for
Drug and Alcohol Studies, VCU School of Medicine, prepared
statement of............................................... 85
Pops, Richard F., chairman, president, and chief executive
officer, Alkermes, Inc., prepared statement of............. 102
Samet, Jeffrey, M.D., MA, MPH, professor of medicine, Boston
University School of Medicine, prepared statement of....... 62
Volkow, Nora D., M.D., Director, National Institute on Drug
Abuse, prepared statement of............................... 20
Warren, Gregory C., MA, MBA, president and CEO, Baltimore
Substance Abuse Systems, Inc., prepared statement of....... 70
Watson, Hon. Diane E., a Representative in Congress from the
State of California........................................ 120
TREATING ADDICTION AS A DISEASE: THE PROMISE OF MEDICATION-ASSISTED
RECOVERY
----------
WEDNESDAY, JUNE 23, 2010
House of Representatives,
Subcommittee on Domestic Policy,
Committee on Oversight and Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2154, Rayburn House Office Building, Hon. Dennis J.
Kucinich (chairman of the subcommittee) presiding.
Present: Representatives Kucinich, Cummings, Watson,
Kennedy, and Jordan.
Staff present: Jaron R. Bourke, staff director; Claire
Coleman and Charles Honig, counsels; Charisma Williams, staff
assistant; Leneal Scott, IT specialist, full committee; John
Cuaderes, minority deputy staff director; Jennifer Safavian,
minority chief counsel for oversight and investigations; Adam
Fromm, minority chief clerk and Member liaison; Kurt Bardella,
minority press secretary; Seamus Kraft, minority director of
new media and press secretary; Justin LoFranco, minority press
assistant and clerk; Howard Denis, minority senior counsel;
Ashley Callen and Sery Kim, minority counsels; and John Ohly
and James Robertson, minority professional staff members.
Mr. Kucinich. The committee will come to order. The
Domestic Policy Subcommittee of the Committee on Oversight and
Government Reform will come to order.
This hearing today will examine the scientific evidence
supporting treating drug addiction as a brain disease and the
development and use of medications to treat addiction and
assist in recovery.
I am hopeful there will be other Members in attendance
today. We are not only competing with General McChrystal today,
but, even more significantly, we are competing with the World
Cup.
So, without objection, the chair and ranking minority
member will have 5 minutes to make opening statements, followed
by openings statements, not to exceed 3 minutes, by any other
Member who seeks recognition.
And, without objection, Members and witnesses may have 5
legislative days to submit a written statement or extraneous
materials for the record.
In its 2006 legislation authorizing the Office of National
Drug Control Policy, Congress specified two main policy goals:
one, reducing illicit drug consumption; and, two, reducing the
consequences of illicit drug use in the United States.
But a neutral observer would have to conclude that this
country's efforts to reduce drug consumption have largely
failed. Rates of overall drug use have held steady, and so have
the numbers of persons dependent on drugs and alcohol, a total
of about 22 million people. It is estimated that 20 million
people needed treatment for addiction in 2008 and did not
receive it.
U.S. demand for drugs fuels an international illicit drug
industry. It is estimated that 70 to 80 percent of the demand
for certain highly addictive drugs is created by just 20 to 30
percent of users.
While we have spent billions of dollars a year trying to
eradicate and intercept such drugs from coming to meet U.S.
demands, the same cannot by said about our national efforts to
curb demand where it begins, with the biological basis for
addiction. Instead, untreated drug and alcohol addiction
overburdens our health care system, and clogs our criminal
justice system with people who should be in treatment, not
behind bars.
As Dr. Nora Volkow of the National Institute on Drug Abuse
will explain today, scientific research definitively shows that
addiction is a treatable medical condition. Like people with
any other medical condition, drug-addicted individuals need to
have access to medications to treat the disease. By relieving
withdrawal systems and reducing cravings, medicines have proven
effective in helping individuals start and remain in behavioral
therapy and achieve long-term recovery.
We will hear from several witnesses today on how
medications help addicts to disengage from drug-seeking and
related criminal behavior and become more productive members of
society. Developing and using effective medications to treat
addiction could make as big a difference in the individual
lives of addicts as their widespread use could make in national
drug control policy.
The Obama administration and the Office of National Drug
Control Policy, under Director Kerlikowske and Deputy Director
Tom McLellan's leadership, have taken a big step forward in
U.S. drug policy by advocating for treating drug abuse as a
public health issue. The 2010 National Drug Control Strategy
supports the development of medications to treat addiction and
recognizes that the effectiveness of addiction treatment has
been hampered by the limited range of available medications
relative to other chronic medical disorders.
Indeed, while the work of the NIDA has brought important
advances in medication development this decade, including
medications to treat opiate addiction and alcoholism, much work
remains to develop and bring more addiction medications to
market. The number of medications available for treating
addiction is far fewer than other chronic illnesses. Currently,
there are no approved medications to treat cocaine or
methamphetamine addiction, despite promising new discoveries in
clinical trial data.
While the scientific knowledge exists, it has not been
translated in new medications. NIDA's budget, just over $1
billion and a small fraction of the national drug control
budget, is simply too small to do this work alone. NIDA needs
more support from the Federal Government and the partnership of
private industry to make progress.
But developing medications for addiction treatment is
currently of little interest to the pharmaceutical industry. We
will hear today from one former and one current pharmaceutical
executive whose companies successfully partnered with NIDA to
develop drugs to treat opiate addiction and alcoholism. They
will address some of the market barriers private industry
perceives to developing these medications and how the
government can incentivize private industry to develop
medications for drug abuse and addiction.
I hope today's hearing will shed some light on the
importance of treating addiction as a medical illness worthy of
medications and how we can support NIDA and private industry in
order to make possible the research and development of
medications which could transform the way we treat addiction.
Thank you very much.
And now I recognize the ranking member of the subcommittee,
Mr. Jordan of Ohio.
Thank you for being here, sir.
[The prepared statement of Hon. Dennis J. Kucinich
follows:]
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Mr. Jordan. Thank you, Mr. Chairman. Thank you for this
hearing.
From stronger enforcement of drug laws to treating those
addicted to drugs, this country's commitment to fight the war
on drugs is important and has taken on multiple forms. I
applaud all the work and the efforts being made by those who
are engaged in this struggle, particularly the individuals and
families who struggle to combat addiction. It is the plight of
these individuals which brings us here today to raise awareness
of a new approach to fighting the war on drugs.
Historically, this country has treated drug addiction
through behavior modifications--for instance, through
counseling. Gradually, through research grants issued by the
NIH, scientists have found drug addiction may be a result of
brain disease and not solely a result of behavior--a condition
which can be treated through medication.
As science changes our understanding about why people use
drugs, the Federal Government needs to be careful not to
endorse just one form of treatment over another but, instead,
support individual choices in the type of treatment that is
most beneficial, because, just as we learned this week,
sometimes the drugs used to treat the addicted become another
form of addiction.
On Monday, the CDC issued a report which found prescription
drugs have overtaken illicit drug use as the number-one reason
for overdose. Troublingly, the top three prescription drugs
being abused--methadone is one of the most popular drugs used
to treat drug addiction.
However we treat addiction, we must have a strong
partnership with the private sector.
Mr. Chairman, I want to thank you for, again, holding this
hearing. And I yield back the balance of my time.
Mr. Kucinich. And I thank the gentleman for the points you
just raised.
I want to start by introducing our first panel.
A. Thomas McLellan, Ph.D., is currently deputy director of
the White House Office of National Drug Control Policy. As
deputy director, Dr. McLellan serves as the primary advisor to
the director on a broad range of drug control issues and
assists in the formulation and implementation of the
President's National Drug Control Strategy.
Dr. McLellan brings 35 years of addiction treatment
research to the position, most recently at the Treatment
Research Institute, a nonprofit organization that he cofounded
in 1992 to transform the way science is used to understand
substance abuse.
Dr. McLellan's contributions to the advancement of
substance abuse research and the application of these findings
to treatment systems and public policy have changed the
landscape of addiction science and improved the lives of
countless Americans and their families.
Dr. Nora Volkow, MD, is the Director of the National
Institute on Drug Abuse [NIDA] at the National Institutes of
Health, a position she has held since May 2003.
As a research psychiatrist and scientist, Dr. Volkow
pioneered the use of brain imaging to investigate the toxic
effects of drugs and their addictive properties. Her work has
been instrumental in demonstrating that drug addiction is a
disease of the human brain.
Dr. Volkow has published more than 445 peer-reviewed
articles and more than 60 book chapters. During her
professional career, she was named recipient of multiple awards
and was recently named one of Time magazine's ``Top 100 People
Who Shape Our World.''
Dr. McLellan, Dr. Volkow, thank you for appearing before
the subcommittee.
It is the policy of the Committee on Oversight and
Government Reform to swear in all witnesses before they
testify. I would ask that you rise and raise your right hands.
[Witnesses sworn.]
Mr. Kucinich. Thank you.
Let the record reflect that both of the witnesses answered
in the affirmative.
I would ask Dr. McLellan to begin and give a brief summary
of your testimony.
Doctor, I would ask that you keep the testimony to under 5
minutes, 5 minutes at most, in length. Your entire statement is
going to be included in the record, and it is much appreciated.
I would like to you begin right now, and then we will go to
Dr. Volkow. Thank you, sir.
STATEMENTS OF A. THOMAS McLELLAN, PH.D., DEPUTY DIRECTOR,
OFFICE OF NATIONAL DRUG CONTROL POLICY; AND NORA D. VOLKOW,
M.D., DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE
STATEMENT OF THOMAS McLELLAN
Mr. McLellan. Chairman Kucinich, Ranking Member Jordan,
distinguished members of the subcommittee, thank you for this
opportunity to appear before you today, and I commend you for
your attention to these critical public health issues that have
been ignored for far too long.
I will begin with some definitions and facts about
substance use derived from well-established science. This
science will introduce what we think is a smarter way to
address the Nation's drug problems, including expanded use of
approved medications through our 2010 National Drug Control
Strategy.
Now, in this hearing, I will use the term ``substance'' to
mean alcohol; street drugs, such as heroin, cocaine, marijuana,
and inhalants; but also pharmaceutical drugs, such as opiates,
sedatives, or stimulants that have not been used as prescribed.
Now, approximately 23 million Americans suffer from either
substance abuse or dependence which threatens their health,
productivity, and relationships, ultimately eroding inhibitory
control, turning drug-seeking into a compulsion, and erasing
motivation for normally pleasurable human relationships.
Thanks to NIDA research, we now know that this is a
biological process, characterized by progressive and long-
lasting perturbations in the reward, motivation, attention, and
inhibitory structures of the brain. In turn, we know the
genetic heritability is a significant factor in determining who
among those who use go on to ultimately become addicted.
So, while we do not have a cure for addictions, we can
manage these illnesses with the same favorable results obtained
in chronic asthma, hypertension, or diabetes. And I think
that's important. Specifically, we now have several FDA-
approved medications for the treatment of alcohol and opiate
addiction. In addition, we have very promising early results
from clinical trials of other medications and of cocaine
vaccines that could markedly reduce relapse.
But it is also a sad fact that the current addiction
treatment system can barely incorporate even the already-
approved medications. The reasons for this are both conceptual
and historical. When the original addiction treatment system
was developed about 40 years ago, addiction was not considered
a medical illness, and, thus, addiction treatment was purposely
segregated from the rest of medical care into then newly
designed specialty treatment system, the so-called rehab
programs.
In 2007, there were about 13,600 addiction treatment
programs, treating over 2 million individuals at a budget of
about $21 billion, the great majority of which were public
funds. Recent data indicate that less than 1 percent of these
funds go toward medication-assisted therapies.
Today, very few medical, nursing, or pharmacy schools
provide even basic training in addiction treatment. Thus, only
about half of contemporary addiction treatment programs employ
even a part-time physician and less than 15 percent employ a
nurse. Very few programs have a formulary, a proper electronic
health record, or even an affiliation with a medical center.
These are the minimum requirements one needs for effective
medical management with pharmaceuticals.
Functionally, this means that physicians rarely make
referrals or play a proper role in continuing care of
recovering patients, as is so often the case with other
illnesses. This is different from the rest of health care, and
it is wrong.
Thus, the National Drug Control Strategy will not just
upgrade the existing specialty care system, though that is very
important; it calls for unprecedented expansion of training for
health care professionals, as well as integration of early
intervention and medication-assisted treatments in the
approximately 7,000 HRSA-funded, federally qualified health
centers and in Indian Health Service clinics. These two Federal
systems treat about 22 million patients already and will
provide an opportunity to properly implement medication-
assisted treatments.
I hope these introductory remarks provide a context for how
we plan to expand medication-assisted treatment within the
President's 2010 Drug Control Strategy.
I have to say at a personal level that, for the first time
in my 35-year career, we finally have effective interventions
to prevent addiction before it starts, to arrest emerging cases
of substance use, and to treat even serious cases of chronic
addiction. We believe our strategy gives us a chance to use
these interventions properly.
Thank you again for the opportunity to testify. I also ask
that you include my full written statement into the hearing
record. And I am happy to answer any of your questions.
[The prepared statement of Mr. McLellan follows:]
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Mr. Kucinich. Thank you very much, Dr. McLellan.
Dr. Volkow, you may proceed.
STATEMENT OF NORA D. VOLKOW
Dr. Volkow. Good morning, Mr. Chairman and members of the
subcommittee. I am very appreciative, as director of the
National Institute on Drug Abuse, to have----
Mr. Kucinich. Dr. Volkow, could you pull that mic a little
bit----
Dr. Volkow. Yes, certainly. I apologize.
Mr. Kucinich. No, no, don't apologize.
I am going to ask staff that, at the beginning, before we
start these hearings, just familiarize the witnesses with the
mics. Thank you very much.
You may proceed.
Dr. Volkow. I apologize, because she did.
Mr. Kucinich. No, please.
Dr. Volkow. My mistake.
Mr. Kucinich. Go ahead.
Dr. Volkow. I do want to thank you for the opportunity to
bring to you the opportunities and roadblocks that have come
across in the development of medications for the treatment of
drug addiction.
Drug addiction, as you all recognize, has a massive impact
in our country. Just from nicotine addiction itself, we can
account for 400,000 deaths every year. The economic costs are
gigantic, half a trillion dollars, and that does not count the
individual losses, as well as family and society of those
involved with drugs.
Science has told us that drug addiction is a disease of the
brain, that it is genetically determined, that the changes in
the brain remain sometimes years after drug discontinuation,
that it affects fundamental areas of the brain that enable us,
for example, to exert control over our desires and emotion,
which explains why a person that is addicted will compulsively
take the drug despite catastrophic consequences to that person
and their family.
However, from this knowledge, we have also learned that
there are specific targets that we can now manipulate through
compounds that, if properly translated into medications, could
transform the way we treat drug addiction and have the
potential also of transforming the way we prevent it.
I am going to just cite three examples to give you a
perspective of how exciting the field is.
No. 1, addiction vaccines. There is data now currently that
vaccines that are targeted toward specific drugs can be
developed to generate antibodies that will neutralize the drug
while it is in the blood, preventing its entrance in the brain.
An example is a vaccine, currently in phase three,
developed for nicotine addiction, which has been shown to
dramatically reduce nicotine consumption, either to complete
abstinence or to reduce the amount of cigarettes utilized.
Similar efforts are being done with cocaine vaccine and for a
heroin vaccine.
Second one relates to a transformation in the way that
medications are being delivered. An example is a medication,
Naltrexone, which actually completely interferes with the
effects of opiate drugs, like heroin or pain medications, to
get into the receptors in the brain. It has not been shown to
be effective in heroin addiction because the patients just stop
taking it. Now new methodologies have enabled to provide it in
a doubled formulation that lasts 4 weeks. And preliminary
results have shown that it dramatically reduces heroin
consumption, 90 percent; that it dramatically increases
retention in treatment, 75 percent; and it decreases craving by
50 percent.
The third example has to do with combinations of
medications that may have been developed for other purposes.
This strategy has been shown to be very effective in the
treatment of many medical diseases, including cancer and HIV.
And preliminary studies have proven its efficacy in the
treatment of cocaine addiction and marijuana addiction, for
which there are no FDA-approved medications.
However, as exciting as these discoveries and strategies
may be, there are serious obstacles that threaten to put the
brakes on their development. One of them is the exorbitant cost
to bring a medication into the clinic. It's estimated to be
approximately $2 billion for bringing one medication into the
clinic.
Now, most of those costs are borne by the pharmaceutical
industry for most of the medical illnesses in combination and
in partnerships with the NIH. And this has been very
successful. Just let's look at HIV. Since 1983, there have been
30 approved medications for the treatment of HIV that were
possible because of the massive investment by pharmaceutical
industry. Now let's contrast that with the number of
medications that we currently have approved for nicotine, which
is a drug for which pharma has made the biggest investments.
Three approved drugs: nicotine replacement therapies,
bupropion, varenicline.
So, why is it that we have not had investment of the
pharmaceutical industry in substance abuse disorders? There are
many factors that have been cited. Among them is stigma, but,
very importantly, major economic disincentives. It is perceived
that the market for addiction is small, when, in fact, it may
not be. It is also clear that many of the substance abusers,
because of the devastating effects of drugs, have lost their
income, their work, and many of them are not properly insured.
So how do we then revert this situation? Which is actually,
by the way, made even worse by the current decision of some of
the major pharma in the world to actually decrease their
investments on medication development for mental illness.
Now, why would that even impact us in the drug abuse field?
Mr. Kucinich. Doctor, I am going to ask you to conclude
your testimony, and then we are definitely going to get to you
with questions that I think will help bring out the rest of it.
Dr. Volkow. Yes.
So, what we have seen is a massive amount of development
and incredible opportunities to bring medication into fruition
in the way that we treat and prevent drug addiction. For us to
succeed we need to create partnerships with the pharmaceutical
industry.
And, with that, I want to thank you for the opportunity.
And I will answer any questions that you may have.
[The prepared statement of Dr. Volkow follows:]
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Mr. Kucinich. Thank you, Dr. Volkow.
We've been joined by Mr. Cummings of Maryland and Mr.
Kennedy of Rhode Island. They will be participating in the
questions of the witnesses.
And I am going to begin with the first round.
Dr. McLellan, if we did treat drug addiction with evidence-
based treatment, including effective medicines, and did so on a
widespread basis, what effect do you think that would have on
the wide-scale problem of illicit drug use, drug trafficking
and drug-related violence?
Mr. McLellan. Well, one of the best examples, Congressman,
is what's happening in AIDS. We find that aggressive treatment
of AIDS not only is reducing the prevalence of AIDS, it is
reducing the incidence of AIDS. That is, by reducing the number
of people affected, you're reducing the number of people----
Mr. Kucinich. Well, let me help focus this. Would it
significantly cut our demand in the United States for illicit
drugs if we had this evidence-based treatment?
Mr. McLellan. Sorry, my hearing is not that good.
Mr. Kucinich. Would it significantly cut demand in the
United States for illicit drugs, for example?
Mr. McLellan. Yes, I think it would cut demand.
Mr. Kucinich. And would it reduce the desirability of the
U.S. market for drug cartels and gangs?
Mr. McLellan. I think that's a plausible conclusion, yes.
Mr. Kucinich. So, based on your years of research, would
you say that evidence-based treatment would make a demonstrable
impact on society?
Mr. McLellan. Yes, definitely.
Mr. Kucinich. So, with so much drug addiction and related
societal costs and with so many actual medical treatments
available and promising compounds for new medications, it
strikes me as being unfortunate that we are not fully invested
in medication development and delivery on a broad scale.
Why is that? Why has that happened?
Mr. McLellan. Yeah, that's--it seems like a simple issue.
There are medications, let's go buy them, let's put them into
play; it is a nice, simple solution. Unfortunately, this is a
complicated issue. And, really, there are four issues that
complicate it.
And the first is insurance. For too long, most of the
people affected were not insured. Second, as Dr. Volkow said
and as I said in my opening testimony, another part is the work
force. We haven't had educated doctors, nurses, pharmacists. So
that's been an important part. Third is stigma, the stigma of
this illness. And combined, they do one thing and they do it
profoundly: They affect the marketplace for pharmaceutical
industries to get into this.
If you don't have coverage to pay for the medications that
would be developed, if you don't have a work force that could
prescribe it, and there's perceived stigma and problems, it is
just not the kind of place that most pharmaceutical companies
have ventured in.
Mr. Kucinich. Well----
Mr. McLellan. We think we can change that, and we have
plans to.
Mr. Kucinich. Dr. Volkow, it has been estimated that 70 to
80 percent U.S. demand for illicit drugs is exercised by 20 to
30 percent of users. Those are addicts and chronic users.
Are there currently medicines available to effectively
treat those addicts and stop a significant proportion of them
from using illicit drugs? And what scientific advances show
promise for the near-term development of new, effective
medications and vaccines that could be used to treat the drug-
addicted population?
Dr. Volkow. Yes, there are very effective medications to
treat heroin addiction. There are very effective medications to
treat alcoholism. There are very effective medications to treat
nicotine addiction. There are no medications approved for
cocaine, marijuana, methamphetamine, inhalants.
What are the promising? In my view, one of the most
promising findings has been the recognition that vaccines can
work. There had been concerns that these vaccines could lead to
increased use to overcome the effects of the antibodies. That
did not materialize. And, currently, we will have results from
the nicotine vaccine trial in the next 2 years.
Mr. Kucinich. Do you have any concerns that this particular
approach could be over-reliant on a behaviorist model?
Dr. Volkow. My perspective is that behavioral interventions
are extraordinarily important, and we don't need to choose a
vaccine versus a behavioral; you use both. Drug addiction is a
very serious condition, substance abuse, and you have to deal
with it aggressively. So, like with cancer, you do behavioral
interventions and you do treatment, medical interventions.
Mr. Kucinich. Thank you very much.
The chair recognizes Mr. Jordan.
Mr. Jordan. I thank the chairman. And that was my question,
or where I wanted to focus.
And let me start with you, Dr. McLellan. And pass along our
best to Mr. Kerlikowske. He's been in front of the committee
many times, and we appreciate his work and your work.
We have had this debate a little bit----
Mr. McLellan. Sir, I am very sorry. Would you mind turning
your mic? I can't hear. I am sorry.
Mr. Jordan. It's usually the other way around that we have
this problem.
Mr. McLellan. Yeah.
Mr. Jordan. This is the first time we've had it this way.
There has been this discussion in your agency about
treatment versus law enforcement and that debate. And now we
have, kind of, maybe even a step further, I guess you could
say, in the question that the chairman just raised.
Do you think, in any way, this focus on using drugs to
treat drug addiction, in any way, is diminishing the affected
person taking personal responsibility, you know, the idea of
individual choice, and some of the underlying concerns that may
have prompted or--maybe ``caused'' is too strong a word--or
contributed to the addiction in the first place?
I mean, I think that's a legitimate concern that I know I
have and raised it in my opening statement and the chairman
just referred to it.
Mr. McLellan. Yes, I noticed that in your statement.
If you imagine that drug addiction is simply bad behavior,
then you'd really be--you want to be very careful that you
don't do anything that would reenforce that bad behavior or,
for God's sake, get other people to initiate it.
But we know very clearly from a lot of research that this
country has already paid for, much of it done by my colleague
Dr. Volkow: Addiction is not just bad behavior.
Drug use is preventable behavior, and our strategy is very
clear on wanting to prevent it because we can. But we don't
know how but we know that, as use continues, a separate disease
process takes over. It erodes the ability to control that use.
So we think the smart thing to do is prevent, is work very
hard to reduce supply, work very hard to prevent drug use
before it starts, get physicians to learn how to recognize and
intervene early on the behaviors and on the consequences of
early drug use. But, once addiction starts, you need
medications, and it is important to add that.
Mr. Jordan. A couple questions. How much money is our
Government currently spending to deal with drug problems, in
all the various agencies?
And then kind of a second question: How do your agency and
NIDA, how do you--the two agencies in front of us here, in
front of the committee, how do you interact and collaborate and
work together?
Mr. McLellan. I am happy to have her give her perspective.
I don't want to give you an exact figure on the amount
that's spent. I can tell you that it is about $22 billion
that's been----
Mr. Jordan. Spread out over HHS and with your--I mean,
where is it at? Give me the general----
Mr. McLellan. I am most comfortable talking about the
treatment of addiction. And it is, in round numbers, $22
billion, about 80 percent of that coming from the Federal
Government, really.
In terms of how we interact, we are interacting in a really
very collegial and collaborative manner. We are working with
all of HHS to train new doctors, nurses, pharmacists. We are
working, as part of the health care reform package, with HHS to
get, for the first time, a benefit into health care reform that
will enable doctors to get paid to recognize, intervene, and
treat addiction before it gets to the point that it is out of
control. And we are working very closely with NIDA to support
new research which is necessary to develop even more tools.
Mr. Jordan. Dr. Volkow, do you want to comment?
Dr. Volkow. Well, one of my perspectives as director of
NIDA is that science that is not useful to improve the quality
of life of individuals is not worth doing. So the partnership
with the other agencies is crucial. And we have had,
traditionally, a very close relationship with ONDCP, since
ONDCP has the ability to integrate the actions of multiple
agencies.
So when there is a priority area--for example, as cited in
the plan for the ONDCP, the increases in psychotherapeutic
abuse in this country--they come to us and say, ``This is one
of our priorities. What is it that you can do from the science
perspective to help reverse it?'' So, at the very basis of how
we make decisions of where we are going to fund research, we
get information and the needs of ONDCP into account.
Our budget, since you were speaking about budgets, just for
research is a billion dollars. And that relates to all of the
drugs. As well, within that amount of money, $300 million set
up for investment on HIV, since drug abuse contributes to it.
There is another institute at the NIH that is involved with
another addiction, alcoholism. And the budget of that agency is
close to half a billion dollars.
Mr. Jordan. Thank you, Mr. Chairman.
Mr. Kucinich. I thank the gentleman.
The chair recognizes Mr. Cummings for 5 minutes.
Mr. Cummings. Thank you very much, Mr. Chairman. I want to
thank you for holding this hearing.
Both of you, it is good to see you all.
Dr. Volkow, you say in your testimony that many
pharmaceutical companies have traditionally shied away from
medications development for illicit drug disorders because of a
relatively small patient population who also tend to be in
lower-income brackets, lack health insurance, or rely on the
State for their care.
With the recent passage of the Patient Protection and
Affordable Care Act, it is going to improve coverage and access
to services for substance abuse disorders in the same primary
care settings as now services all other illnesses.
What are we doing to incentivize pharmaceutical companies
to experiment and produce new drugs?
Dr. Volkow. Thanks for that question. Actually, it is a
very relevant one, and it is a question that we have posed
ourselves in the health system 15 years ago, and the Institute
of Medicine actually called in a committee to try to answer
that question. How is sitting in the line of the urgency of
developing medications, the opportunities and the lack of
investment from pharmaceutical, that we can reverse that trend.
The Institute of Medicine came up with very specific
recommendations that would have unfortunately not been
implemented.
What are some of those recommendations? Having to give, for
example, a protected market for a given medication. So those
recommendations still apply. I think that in the meantime,
though, there are much greater opportunities that you just
cited.
Many individuals who did not have a way of paying will now
be able do so. And that's why, at this present moment, we have
a unique opportunity to try to engage pharmaceutical companies
into partnering in ways that will be beneficial for them and
beneficial for the country.
Mr. McLellan. If I may, I would like to add to that another
part, and that is training for physicians.
Physicians and nurses don't get the training they need in
this illness and, thus, are not comfortable prescribing any
medication. So another opportunity, in addition to the ones Dr.
Volkow talks about, is the work now going on to try to get
physicians, and particularly primary care physicians, to become
facile with these new medications and have a basic
understanding of these diseases.
Mr. Cummings. You know, there was just a recent article
about how difficult it is, how many students, medical students,
don't want to go into primary care. And, of course, we have
some things in that bill to try to incentivize.
But, you know, we've been dealing with these kinds of
issues for a long time. And other than the things that you've
just said, how do we guarantee ourselves the--rather than, say,
going on a merry-go-round, where we seem to make little
progress, how do we maximize the probability of actually being
effective and efficient with regard to the things you're
talking about?
Either one of you, or both.
Dr. Volkow. Well, there are two questions, one of them that
relates to the need to build infrastructure in the health care
system. So when patients that now have insurance come for
health, for the treatment of drug addiction, there will be
specialties that can actually take care of them. That's a
crucial component.
The second one, which has been more complex, is involvement
of the pharmaceutical industry. And, again, pharmaceutical,
like any private industry, will be incentivized if there is
success with a given medication.
So right now, with a new perspective with respect to
vaccines development, that I predict we will be successful with
nicotine vaccine--I predict that will incentivize other
pharmaceuticals to go for treatments that are illicit
substances.
For the illicit substances, we still have a very limited
market that integrates the involvement of private companies.
Currently, as we speak, the Institute of Medicine is holding a
conference to try to figure out ways in which we can, sort of,
contain or reverse the disengagement of pharmaceutical--not on
substance abuse, because they have not been very much involved,
but on development of medications for depression, for
schizophrenia, for anxiety.
For mental illnesses, we've seen a decrease in the
investments, and these will be catastrophic. And it is
catastrophic for us because we take advantage of those
medications that may be used for depression, in some instances
are useful for addiction.
It is going to end, at the end of the day, by coming up
with compromises on the way that we do things. The IOM already
came about it. We need to incentivize the pharmaceutical
industry if we want to have this medications development, just
like we incentivize for other needs. If the country needs tanks
to go to war, we need to incentivize the companies that do
them. Otherwise, spontaneously, it is not going to happen.
This is urgent. Hundreds of thousands of people's lives are
ruined because of drug addiction. It need not be like that. We
have the science. We know how to develop it. We just don't have
the resources to get it to the next level.
Mr. Cummings. I see my time is up. Thank you, Mr. Chairman.
Mr. Kucinich. The chair recognizes Mr. Kennedy.
Mr. Kennedy. Welcome.
If you could address the point that I want to make, and
that is that we don't have an addiction treatment system
whatsoever in our country.
Personally, I've made a very close personal analysis of
treatment centers. I've gone to the best in the country,
myself: Mayo, Ashley, Sierra Tucson, others. It's all based
upon treating based upon your weaknesses instead of treating
based upon your strengths. And it is outside where you live, so
it doesn't help you in the course of your life.
And our reimbursement system doesn't--forget the
specialties. All you really need if you're trying to stay on
the wagon is to have someone in your life on a consistent basis
help you.
And I am wondering, to what extent have you allowed in the
regulations that are now being done to implement parity, to
allow those with neurological disorders--and this is a
neurological disorder because it is a chemical imbalance that
people try to self-medicate to address; hence, the reason we
are talking about pharmaceuticals to help address.
Are we doing something to allow insurance policies to pay
for nonmedical services, like having someone stay on top of you
and making sure that you don't have this, ``90 and 90, there
you go, you're off on your own,'' as opposed to someone has to
have only acute episodic care because that's the only thing
that we have reimbursable under our current insurance system.
And it is so costly, and yet it is so ineffective. And why
are we paying for it in this country? And it's the best that we
have out there, it's the gold standard, and, yet, it's awful.
Mr. McLellan. Something that is painfully obvious to you is
not clear to the rest of America, and that is that addiction is
a disease and it is a chronic disease. Unfortunately, for a
very long time, we've been thinking about this as bad behavior
that needs an acute, rapid lesson in life. Well, if we treated
diabetes or hypertension or asthma that way, we'd have terrible
results.
So, two answers to your question. I think the very
recognition that we've been thinking about this in the wrong
way and segregating a treatment system away from the rest of
medicine has not served us well. So we are off of that, and we
are on to, I think, the right thinking and the right model.
Mr. Kennedy. Now, tell me, what are we going to do to
certify treatment providers so people don't end up continuing
to waste all their money on everything out there that's so bad
and not getting any results?
Mr. McLellan. I want to say--and I am sorry Representative
Cummings isn't here. I do not feel the kind of skepticism and
worry that is apparent so much in the questioning. This is a
very good time. I think we've got it right and we are making
real progress now.
And to that question, we have the attention of all the
primary care medical societies. They have recognition that they
need the kind of training that's necessary to properly certify
them. We are working with the National Board of Medical
Examiners to, at a fundamental level, test kids coming out of
medical schools and other schools on these issues. We are
including benefits that will----
Mr. Kennedy. I love what you're doing on that. I just have
to get all this stuff on the record.
Mr. McLellan. Yeah.
Mr. Kennedy. Why don't we have an NCQA, an agency for
health care research, certifying these mental health providers
and not certifying them because they are not doing what they
are supposed to do? Or shutting them down.
Mr. McLellan. That is a very good idea.
Mr. Kennedy [continuing]. So they are not wasting people's
money anymore and pretending like they are giving people
treatment when they are not.
And having people, instead, when they are spending their
30-grand a month, spending it over the course of a year to have
someone in their lives that helps them in their own community.
Why aren't we telling the insurers, ``This is the model?'' And
why aren't we doing it in the VA, so that's what they look for
as the model?
Mr. McLellan. I think we are on the right track,
Congressman. And I think you're going to see progress very
shortly in just that area.
Mr. Kennedy. Well, we have an opportunity in the
implementation of these regs on parity to actually reimburse
for this model of care that's nonmedical, which is actually
most productive for dealing with chronic illnesses of a
neurological nature. And this helps people with autism,
Alzheimer's, Parkinson's, you know, everybody. So our fight is
the fight for everybody.
And I would make that point with respect to the IOM report
on drugs. We don't need to incentivize pharmaceuticals. All we
need to do is get everyone to double down on research of the
brain, and we will find out that there are great answers for
pharmaceuticals to go into treatment for depression and
addiction too. But it will come when everyone else is fighting
for just basic research in neuroscience.
You know, forget the silo of trying to get them to
incentivize for drug addiction, because you don't have popular
will to do that. I mean, I know Nora knows stigma well enough
to know that's not being to happen.
Mr. Kucinich. I thank the gentleman.
I just want to say that we in the Congress are proud of
Representative Kennedy's courage and his advocacy, and it is
important for the Nation.
Thank you, Mr. Kennedy.
The chair recognizes the distinguished Congresswoman from
California, Ms. Watson.
Ms. Watson. Thank you so much, Mr. Chairman.
I can't think of a subject any more needed for attention
than the one that we are addressing today. Because I think of
some decades in the past--and I represent Los Angeles, and our
bus drivers were driving buses and the buses were turning over
on the freeway without accidents. My nephew was a bus driver,
so I said to him, ``What's going on out there?'' He said,
``Most of the bus drivers are using crack cocaine.''
So I went to the supervisor, and I said to him, ``You know
what you need to do? You need to test. Because the lives of all
of your employees and the lives of our citizens are at stake.
And the people who are driving these buses are buying homes,
have children in school, and we just cannot throw them away.''
So they started to do random testing, but I put a bill in,
so that we could have neighborhood--and I am addressing this to
my colleague, Mr. Kennedy, for some of the remarks he made--so
we could have neighborhood treatment centers where people could
walk in and get treatment. It got all the way up to the
Governor, and he said that it was too expensive and vetoed the
bill.
Ever since then, we have the largest prison population in
the country. And 50 percent of those incarcerated were addicted
to drugs, and they get very little treatment or not the right
kind of treatment in these institutions.
It has been a concern of mine forever. I chaired the Health
and Human Services Committee in the Senate in California for 17
years. Every year we would put a bill in, and we couldn't get
it funded. Now the State is broke, so I doubt if we will ever
have a program.
So, what is the Office of National Drug Control's strategy
for providing those who are incarcerated with the treatment
they need to reduce reincarceration, relapse, and overdose
rates? And what role should drug addiction medications play in
this treatment?
And this is to the two of you.
Mr. McLellan. I can think of no more important question.
It's one of the key parts of our Drug Control Strategy, partly
because of the volume of the problem, the numbers of people
affected and the importance.
It also is a question that illustrates something that I
think I would like to make as a general comment. I'd be very
careful about thinking of pitting one strategy, medication,
versus supply reduction versus behavioral treatment. We don't
want to do that. We want it all.
Ms. Watson. Comprehensive?
Mr. McLellan. Comprehensive, and particularly for those
populations where there is a combination of risk to the
community as well as a public health risk.
The good news is, we can. There are effective things that
can be done, have been shown. And we've put money in the 2011
budget to incentivize just those things through the National
Institute of Justice. Like what? Well, drug courts are an
excellent example. The principals of drug courts--swift,
certain sanctions, but modest--combined with evidence-based
treatment and prevention strategies give you the very best
opportunity to fight with both hands, to use all the tools that
you have.
We want to apply those principles in reentry. We want to
apply those principles particularly in community-oriented
corrections, because there are so many--there are
approximately--we use the same data you do, and we think about
2\1/2\ million people are in the community under corrections
with a substance abuse problem. If it is not addressed, it's
going to lead to re-addiction, re-offense, reincarceration, and
a huge expense.
Again, the good news is there are models out there that
have been shown to work that reduce all of those things: keep
communities safe, reduce the drug use, save a lot of money.
Dr. Volkow. And just to make a point about medications in
the criminal justice system, that's in an area where the
evidence is so strong, that, in fact, we don't need more
evidence. Treating with medications while in the criminal
justice system and maintaining that treatment once the prisoner
is released is not just significantly beneficial for the
person, vis-a-vis their drug use, but it dramatically reduces
their rate of reincarceration.
So it is a win-win with respect to the drug use behavior
and with respect to the criminal behavior. So it is not just
cost-effective, it is actually cost-saving.
Ms. Watson. If I may, just 1 second more, Mr. Chairman.
I represent an area in Los Angeles called Hollywood, and
there's not a time when you read the newspapers, turn on your
TV or your radio to see some young celebrity involved with
drugs. It is rampant in that community.
And the reason why I said, Dr. McLellan, that we needed to
look at a comprehensive approach, because these people are
dealing with psychological, emotional problems leading to their
drug use--too much too soon too fast, too much fame and so on.
And so we have to have the right combination.
And as my colleague Mr. Kennedy said, it needs to be close
to home, where we can deal with all the factors that impact on
people in a community like this, let alone the poor, poverty-
stricken communities and their use just to get away from their
real lives. So we have to have that comprehensive approach that
treats the whole person and the entire community at the same
time.
Thank you so very much.
Thank you for the time, Mr. Chairman.
Mr. Kucinich. I thank the gentlelady.
We are going to begin a second round of questioning of the
witnesses. We are going to begin with Mr. Kennedy for 5
minutes.
You may proceed.
Mr. Kennedy. Thank you.
I can't emphasize enough the feeling of outrage I have
about this treatment. Because you can think about this stuff
until you're blue in the face, you can learn about it until the
end of the world, you can get all the emotional and
psychological treatment until the end of the earth, and it is
not going to change your behavior.
And we don't have any behavioral changes going on in these
treatment facilities, no behavioral modification. If you don't
change your behavior, your thinking won't change. It's the key.
So you fill everybody up with a head full of AA and program
and treatment, and it's not going to do them a bit of good
because you send them out, they are thinking a different thing
but they are still acting the way they were when they went in.
It is so basic, and yet we are doing it everywhere. And the
problem with all of this is that we have this stigma, and it is
just being perpetuated right now, because all we are doing is
talking about, understandably, the symptoms and people
incarcerated and people on crack driving buses and blah, blah,
blah.
The bottom line is, the biggest challenge going forward is
narcotic analgesics are the biggest-prescribed drugs in this
country. And our veterans are being prescribed this at record
rates to deal with the symptoms of the signature wound on this
war: TBI and PTSD.
We shouldn't at all in this hearing be talking about
criminal justice, you know, all of these stigmatized drugs. We
should be talking about people self-medicating. And we should
be focusing on the people that everybody understands are self-
medicating because of their service to our country. Because
that destigmatizes it and people get it.
And it is a huge problem; it is going to get bigger. And
our fight should by the fight for our veterans. And if we can't
even get it right in the VA, which is clearly--they don't even
have metrics for this--I am wondering, what are we doing? I
mean, even VISN to VISN has different approaches. They are just
writing. It's just--where are we?
And if we can't get it right with these regs that we are
trying to put in place now for this health bill, 72 percent of
all vets are never going to see a VA. They are going to get
their health care through this private insurance plan. That
health care bill was a veterans bill. Of the remaining 28
percent, 67 percent of them are also going to get supplemental
private health insurance coverage.
What are we doing to make sure those private health plans
are sensitive to veterans' needs and dealing with wrap-around
services for their brain trauma so they are not self-medicating
because of the trauma and the brain damage?
If we address that, if we do research on neuroscience for
the veteran, believe me, pharma is going to come to the table
on all of the other things, because we are going to get all the
extra money we need to deal with brain issues. And, in the
process, we are going to find out about treating depression,
treating addiction, treating everything else.
If we go out at this way that we are talking about now,
trying to deal with the return, the recidivism for convictions,
all of that, yeah, it makes sense for us on a budget, it makes
sense for us on a human level, but it just doesn't make sense
politically. And we are fooling ourselves if we are going to
spend any time talking about it and thinking we are going to go
anywhere, especially in this environment of austere budgets.
So what I want to know is, why aren't we getting our act
together with the VA? And why aren't we getting our act
together with implementing regs that actually do supportive
living, supportive employment, and supportive education, so
people can live with the chronic illness over life as opposed
to paying hundreds and hundreds of millions, billions of
dollars in these no-win treatment settings that are gold-plated
losers in terms of helping people perpetuate their thinking
they are getting treatment when they are not?
I mean, we are sitting here--I mean, no offense. We are
talking--you just said--that's a very good question, but it
doesn't address the big picture. This is the big picture. We
are not getting it right, the implementation of the regs, and
we are not doing it at the VA, which is where all of the
insurers take their lesson from.
How are we going get anywhere if we don't do it right in
those two places?
Dr. Volkow. Well, one of the things that I was thinking is
that we are going to be faced with the veterans returning from
this war with problems that, in medicine, we have not really
addressed in the past. The level of trauma that they are
surviving will very undoubtedly lead to many more cases of
severe chronic pain, No. 1. No. 2, you mentioned TBI, which is
also something that, in many ways, this war has exposed us to.
So we don't even have sufficient knowledge on how to treat
these conditions. For chronic pain, we use opiate analgesics,
and we treat it as if it were acute pain times so many months.
Dr. Volkow. We have thought in the past that will prevent
these individuals from getting addicted to their pain
medication. We're finding otherwise.
So one of the areas that we are investing in at the
Institute is to develop medications and knowledge regarding the
treatment and management of chronic pain to minimize the
likelihood that those individuals become addicted to their
medication and that they can control their pain. But we do not
at this point have sufficient knowledge.
Mr. Kennedy. Well, Dr. Steinberg at Stanford University,
head of neuroscience, says he does. He says he can interrupt
the neuropathways to block pain. I said, why aren't you
introducing it? He said, I'm about to at the VA system at
Stanford, and hopefully they can take it nationwide.
The neuroscience that is going on in this country is
breakthrough. The notion that we can't start to cut the
pathways to pain and treat it without doing these narcotic
analgesics and hook a whole generation of vets is shameful on
us as a country, that we're about to addict all these people
and then send them off to do other illicit drugs, like heroin
and the rest, when they're not getting enough narcotics from
their docs. I mean, to me, we're missing the big picture again.
Dr. Volkow. I agree, and it is a priority area for our
Institute.
Mr. Kennedy. If you want to talk about addiction, let's
talk about what we're doing to addict a whole generation of
American heroes. We're leaving them prisoners in our country,
stranded behind the enemy lines of their signature wound on the
war. They are being held hostage right now by this disease,
because we're not treating it right.
This has nothing to do with crack addicts in California
driving buses or prisoners in prison. This is about our
American heroes. Let's keep it that way. Because, if we do, we
can move forward on this. If we start talking about everything
else, we're losing it.
Our fight is neuroscience. It's those with Alzheimer's,
autism, epilepsy, Parkinson's. Because it's all the same brain.
Once we do research on that, we're going to get pharma to come
to the table. We need to do neuroscience research, and they'll
all see the great discoveries, and they're going to want to be
at the table. Because they're going to realize there are going
to be answers to all of these other neurological disorders.
And if we do the implementation for treatment right for
addiction, guess what? Then it's right for those with
Alzheimer's, right for those with Parkinson's, right for those
with autism. Why aren't we getting this in the regs now and
just segmenting it for neurological disorders in this parity
reg?
Dr. Volkow. Patrick, I'm going to answer you. Because this
is exactly--and I really admire your passion.
While I'm sitting down and listening that Pfizer Wyatt got
rid of 1,000 neuroscientists, and Glaxo basically closed their
psychotherapeutic development program. I'm seeing that Merck is
also downsizing. I'm also hearing that Lilly is also
downsizing, despite all of the advances in neuroscience; and it
is because they have not been very successful of bringing
medications into the clinic.
Many factors account for it. One of them is cost. What it
is, they have not been very successful at all. There are other
areas where medications--they have been able to get investments
back, like cardiovascular disease. But psychotherapeutics has
been an area that many of the pharma are starting to cut. And
that's why I brought it up, because I think that we, as a
country, are going to lose enormously if that continues to
happen if we don't contain it.
Mr. Kennedy. My point would be you get Office of Management
and Budget and they look at this bill, they see we're on the
hook for everybody with neurological disorders. The cost for
Alzheimer's is going to skyrocket. We're all paying for it.
Autism, skyrocket. Parkinson's, epilepsy, and now the veterans
population with TBI and PTSD. We're on the hook as Uncle Sam
big time. We had better invest or else we're going to be paying
through the back end.
So it's going to pay for us as a government to step up and
do the down payment on research, on neuroscience or else we're
going to be paying though the back end. And this is where we
need the IOM to say to the Federal Government, here's a way
out. If we're going to have cost-effective, comparative
effectiveness in this bill, here's where it counts. Comparative
effectiveness analysis shows if we research this stuff here,
we're going to get interventions that are going to make a huge
difference in just putting off the onset of Alzheimer's,
mitigating the impact of autism, you know, mitigating the
impact of schizophrenia, allowing these vets, which we're all
ready to do, to repair spinal cords so they can get out of
their wheelchairs and get into society.
And I mean for us to think--for us not to think big and
think that the addiction field is there with Alzheimer's,
autism, and all of the rest, think as one mind with the brain
and not think big pharma is going to come if we get one picture
on this in the vision. I think so.
I mean, I think if you define it that a neuroscientist gave
me one more year with my dad. Neuroscience is going to give a
family with Alzheimer's, bring the memory back for their loved
one. A neuroscientist is going to help a family with a kid with
autism or Parkinson's or schizophrenia to not have to worry as
much while that child grows up about being marginalized.
They're our first responders in this war on the biggest
burden of illness which is neurological disorders. They're
going to set us free. These neuroscientists are going to go in
there and they're going to set us free, first and foremost our
veterans. If we can't get that message across, we don't deserve
to be in our business. I mean, this is it. This is going to
save people's lives in huge ways. We're in the weeds here.
We're in the weeds right now.
Dr. Volkow. I agree, and that's one of the reasons why I'm
very grateful to be here and being able to present the
obstacles that we are facing.
And I will definitively--since the meeting isn't going
right now at the IOM--highlight your point and your request
that the IOM come up with very specific points and that can be
used to guide how to revert these changes that we're seeing in
the pharmaceutical companies.
And I will also for the record be willing to provide the
committee with the information regarding this investment, the
decreasing investments from pharmaceutical industry for
psychotherapeutics. I think we need to be aware of this.
Mr. Kennedy. I would like to get that answer on functional
reimbursement for neurological disorders in this parity bill.
You all at ONDCP, at NIH, the experts in the field, have to
weigh in with HHS. This comment period is still open.
If we don't reimburse for continued support for chronic
illnesses--addiction is one of them, but all of the other ones
that I just mentioned are also--we're missing the change from
sick care to health care. We're missing a big opportunity.
Mr. McLellan. I would just add that, historically, you've
got a terrific precedent on your side, as I was around when the
first addiction treatment system was developed. And it was
developed to treat the then opiate problems of returning
veterans from a foreign war. If that hadn't happened, there
would have been no political will to create that system. Well,
we need to advance beyond that, as you have said.
The science is there. I agree with you. Absolutely,
veterans need to have the same kind of care for their
neurological behavioral problems that they have for their
cardiovascular problems. Now they don't. If we follow our
strategy, if we vigorously defend parity and vigorously
implement the health care reform, they'll have that chance.
Mr. Kucinich. I think one of the things that the
gentleman's question brings up is where are we with respect to
nonnarcotic, nonaddictive pain relief.
I thank the gentleman for his questions.
I'm going to recognize Ms. Watson, if she would like to.
Ms. Watson. I yield back.
Mr. Kucinich. I'll take my 5 minutes right now. Dr.
McLellan, we heard from Dr. Volkow that it's cost effective to
treat prisoners with medications while in prison and before
release to prevent relapse and recidivism. Does the
administration have plans to expand access to medications in
the criminal justice system?
Mr. McLellan. Yes. We have plans to expand that access in
prisons but also in communities for individuals who jointly
have criminal justice problems that are associated with their
addiction as well as the addiction itself.
So we don't just want to do it in jails or prisons. We want
to do it for people who are under parole and probation. We want
to do it for people who are reentering. And, yes, there are
provisions through the National Institute of Justice and
building upon the evidence-based behavioral interventions but
also the medications that Dr. Valkow spoke of.
Mr. Kucinich. Thank you.
Dr. Volkow, in terms of neuroresearch, once pathways are
developed through addiction and a person kicks their habit, do
those pathways still exist in a way that can inform other types
of repetitive behaviors that are not necessarily--that are, in
effect, a side effect, notwithstanding their kicking their drug
habit?
Dr. Volkow. That's actually a very important question. Many
investigators have tried to address the consequence how long do
the brain changes last after you stop taking the drug; and if
they do not revert back to normal, what are the consequences on
behavior, which is one of I think your very specific question.
What research shows is that there is significant
variability in terms of the ability of the human brain to
recover. In some cases, you see almost complete biochemical
recovery of the abnormalities and in others you don't. And when
you don't see the recovery, what you do see is derangement and
increased reactivity to stress on people that have been
addicted to drug addiction, even after years they stopped
taking them. And this, of course, puts them at much greater
risk to relapse. Because if they encounter an adverse situation
like losing their job or losing someone they love, that is a
period of great risk for relapse because of that enhanced
sensitivity to stress that was developed from the chronic use
of drugs.
Mr. Kucinich. In the case of alcohol abuse, someone who's a
long term alcoholic can develop what's known as an
encephalopathy that is really an organic change in the brain.
What does the research show about parallel organic brain
syndromes with respect to drug addiction and the ability of the
human brain to recover?
Dr. Volkow. Well, there are--I mean, there are differences
among the drugs. Some of the drugs are more toxic than others.
Among the most toxic drugs, we have methamphetamine.
Methamphetamine, with repeated use, can produce damage of cells
like the dopamine cells that are very important in your ability
to perceive pleasure and excitement. So the repeated use of
these drugs can lead individuals, even years after they've
stopped taking the drug, with a lot of excitement, with what we
call in psychiatry, anatonia, the ability to perceive pleasure
with a lack of motivation.
Mr. Kucinich. What about cocaine addiction? What's the
physiology in terms of cocaine addiction and what damage is
done?
Dr. Volkow. The damage from cocaine comes from an effect of
cocaine on blood vessels. It is a vasoconstrictor, and that
means it decreases the flow to your heart. It decreases the
flow to the brain. And that's why we started to see myocardial
infarction in young people when they were taking cocaine. But
that also happens in your brain.
Mr. Kucinich. Long-term effect?
Dr. Volkow. When you have damage from lack of blood into
your brain, that can be long-lasting; and if the cells are
dead, there is no way that you can actually bring them back.
What you can do--
Mr. Kucinich. What about behavioral effects long term?
Dr. Volkow. With cocaine, if you have a stroke within the
motor areas of the brain, that will leave you paralyzed and you
will not necessarily recover your full motion. If you have it
in the back of your head where you see vision, that could leave
you blind. If you have it in an area that's involved in more
silent types of behavior like thinking, that will lead to
destruction in thinking.
So it is a matter almost like a roulette. Where do you have
the stroke in your brain that's produced from the effect of
cocaine. That will lead to the symptoms.
There is recovery, though. We know that the adult brain can
recover even from strokes, and what happens is the rest of the
brain can take over. The younger you are, the better your
prognosis, because your brain is more plastic. But the addict's
brain can still recover by engaging other areas of the brain to
take that activity.
So even with strokes from drug use, we expect recovery in
those patients if they receive proper treatment.
Mr. McLellan. I would like to add something that's less
perceived but as insidious. People wonder why after long
periods of time, let's say an incarceration, a person would use
a drug. Haven't they learned their lesson? Don't they realize
that drugs are bad? Don't tell me it's brain changes that do
that. And the answer is, yes, it is brain changes.
We know that cues that have been associated with drug use--
people, places, things--have the ability not to just to remind
somebody about drug use, they have the ability to elicit the
same changes as the drugs themselves in the brain. They light
up--Dr. Volkow's work has shown they light up the same
structures of the brain. They produce powerful craving even
when they haven't used.
Mr. Kucinich. What do you mean ``they?''
Mr. McLellan. ``They'' is any stimulus that has been
associated with drug use.
I've come out of jail. I haven't used cocaine for a long
time. I run into Joey and Billy, the guys I used to use cocaine
with. Not only do I know, because my mother told me so, these
are not the guys to hang around with, that elicits powerful
craving that you can show in an MRI. And that is part of the
reason relapse rates are as high as they are. There are
behavioral changes brought about through learned associations.
Mr. Kucinich. We've heard of research where women who are
pregnant who are drug addicted that has an effect on the fetus,
the child; is that correct?
Dr. Volkow. That is correct.
Mr. Kucinich. So would then pharmaceutical-related
treatments block those receptors in the fetus or newborn as
well?
Dr. Volkow. Incredibly important question.
Drugs of abuse enter the fetus brain, and
psychotherapeutics will also enter the fetus brain. What we do
not know sufficiently is the extent to which some of these
psychotherapeutics could also be potentially harmful for the
fetus.
Take an example. Nicotine replacement therapy for smoking
cessation on a woman that is pregnant, nicotine is in utero
damage. It produces damage to the brain of the infant. If you
give a nicotine replacement therapy, the nicotine will go into
the fetus and affect it.
So the handling of the substance abuser that's pregnant
with medication is an area that requires specific research on
any one given medication to ensure that we will not do damage.
Mr. Kucinich. Let me conclude this panel with one question.
It's kind of an obvious question. It may not get asked because
it is so obvious, but I would like to hear an answer from both
of you. Why do we have this tremendous number of people who are
on drugs? What's happened in our society? Why? I mean, you must
ask yourself even as you're trying to deal with the mechanics
of treatment, why? What do you think--why do we have this kind
of wide-spread drug abuse?
Mr. McLellan. You are talking to the wrong guy. I've
devoted my whole life to this, and my family is riddled with
it, and I'm worried every moment of every day about my
grandsons.
Here is my answer. I'll tell you what I know, and I'll tell
you what I think.
What I know is drug use is different than drug addiction.
Drug use is a function of availability, access, ease of
availability, like any other attractive commodity. You make
more candy bars available, more people use candy bars. That is
a fact. Second, another thing I know is that abuse and
addiction is partially a function of genetics. We don't know
how much, but we know that it contributes about the same amount
of expression of illness as genetics contribute to the
expression of diabetes, hypertension, and asthma. So when you
have an extremely wealthy country that has an abundance of
access to drugs of different types of different varieties, you
have more opportunities to use and more people who are using.
Once that happens, the disease process--you know, the disease
of addiction as well as the side effects of drunk driving and
accidents and all of the other sequelae of just simple use take
effect.
That's why as a guy who does treatment research my whole
life I don't want to just see treatment be the only answer to
the drug problem. We need supply reduction as well as many more
medications and much better prevention.
That's everything that I know. That's what I tell my
grandkids right there.
Mr. Kucinich. Dr. Volkow.
Dr. Volkow. I think that there are many reasons why we have
people end up taking drugs and becoming addicted. The issue of
availability is a crucial factor. The more a substance is
available, the more probability that the kids will start using
it; and the younger they start using drugs, they raise the risk
to become addicted. That's No. 1.
No. 2, we also, of course, recognize the issue of genetics.
So if you come from a family where there is a history of
addiction--which I also have in my family--they are more
vulnerable to being addicted.
Three, there is another factor that we know that
contributes, and that is almost any type of mental disorder
will increase your vulnerability to taking drugs; and that can
be depression, anxiety, schizophrenia, attention deficit
disorder. Why? Because you may then use the medication not just
to get high but to feel better.
And in fact in this country, for example, those that remain
as smokers, there is a great overrepresentation of individuals
with mental illness. So a mental disorder will put you at
greater risk.
So those are three factors that are biological that will
increase your vulnerability. Now, why is it if it is genetic--
and this is a more basic question. Why is it that those genes
remain if they are adverse and have these negative
consequences? And, of course, that is a very fascinating
question with respect to why is it that some people become
compulsive users and cannot stop it. That plays to basic
understanding about how the brain creates memories, how some
people can learn faster than others. Well, that may come to a
certain price.
So this plasticity of the brain is one of the factors that
contributes to that vulnerability of the addiction, but that
plasticity is also extraordinary important in allowing us to
learn.
Mr. Kucinich. You know, this has been a very important
discussion, and I saw Mr. Cummings came back, and Ms. Watson
has not asked questions this round. Before we dismiss this
panel, do you, Madam, have any questions?
Ms. Watson. If you will yield for just a moment.
Mr. Kucinich. I will, and also Mr. Cummings. Because I
guess there are questions that are very deep here, and I just
want to make sure that the Members of Congress who are present
have a chance. We're about to dismiss this panel, but, before
we do, do you have a final question?
Ms. Watson. Coincidentally, I have an appointment at 2:30
today with Erika Christensen. She is an actress, and she's in
my district in Hollywood now, and her mission on the Hill today
is to promote the importance of substance abuse education and
to talk about it as a crime preventative tool and the
importance of treatment in front in diversion as a way to
reduce the recidivism rates of offenders who are already in the
criminal justice system.
I just asked my staff to see if we could locate her in the
building now. She will be here today and tomorrow and see if
she can come at the end of the second panel.
Mr. Kucinich. Without objection, that would be fine. Mr.
Cummings, do you have any questions?
Mr. Cummings. Yes, I do. I want to pick up where you left
off. I live in the inner city of Baltimore, inner city. I have
been there all my life, and I see a lot of young people who I
have known since they were toddlers. Some of them sadly have
grown up to be drug addicted. Others have gone on to college
and done well. And I'm always curious as to how they got into
it.
And when I talk and, Dr. Volkow, when I was listening to
what you were just saying a moment ago, you talked about the
mental illness part. I know there is something called clinical
depression; and I assume there are other kinds of depression,
too.
I notice that a lot of these young people don't have a
sense of hope. I'm just telling you. They don't--it's hard for
them to see a future. A lot of young women tell me that they
got involved in drug addiction because of some young man,
trying to impress somebody, some guy. He talks them into it.
Oh, just only take one time. You'll be fine. And the next thing
you know, she's in pretty bad shape. There are--and the thing
that I guess that really gets me is how drug addiction can
change a person drastically from a person who may have been
honest to someone who lies all the time; from someone who has
never stolen anything to someone who will steal; from someone
who never thought about harming another person to someone who
will kill someone.
I tell people quite often, while I love my neighborhood,
quite often most of the time I sleep better outside of my
neighborhood than in my neighborhood. Because I realize a lot
of the very young people that I watched grow up with that will
say, Mr. Cummings, how are you doing, show a lot of respect.
Having been a criminal lawyer, I can tell you I know that in
certain circumstances they could harm me. As a matter of fact,
my predecessor, Parren Mitchell, who was well respected, was
robbed at least three or four times. And we lived literally in
the same neighborhood. And, by the way, by the same young
people that had a phenomenal amount of respect for him.
I guess my question goes to is there--I mean, you know, you
talk about mental illness. We see people who spend thousands
upon thousands of dollars every year to address mental illness.
So we've got--but yet and still it seems like not a lot with
regard to mental illness is addressed when we give somebody
medication or whatever. Are we balancing that or has our
society come to even accept the fact that drug addiction is
usually accompanied by some type of mental problem?
And the reason why I started off the way I started off this
question is because a lot of times people may have a problem,
but it may not be classified as mental illness. Because I
believe you can be--I believe you can be so depressed over your
circumstances that you don't even know you may have a mental
problem. So I'm just wondering. I just want your reaction to
that, and then I'm finished.
Dr. Volkow. Yes, and I think that is absolutely correct.
And I think one of the recommendations that we need as an
agency is to start with, for example, young people that end up
in the criminal justice system with a problem with drugs that
they be evaluated for the possibility that they may have a
psychiatric disorder that has not been recognized. And, indeed,
on the recognition of mental illness in adolescents, where it
is not full-blown, as you see it in adults, it is not an easy
thing to do. So many kids go around feeling depressed, with a
learning disorder and taking drugs without realizing why they
are doing it. So that is something that we can address. Then
your second question, because that is a problem that we have in
the country that should be taken care of, which is we basically
separated, divorced, the treatment of drug abuse from the
treatment of mental illness. I'm a psychiatrist. I was trained
at New York University. I was not trained to deal with the
substance abuse problems of mentally ill patients, even though
85 percent of them suffers from some type of addiction
behavior. So we've separated that care of substance abuse from
that of mental illness, rather than integrating. Because--guess
what--it comes together in both directions. So if you take
drugs, that may increase your vulnerability for a mental
illness. If you have another mental illness like depression,
that increases your vulnerability for substance abuse disorder.
This is something that we need to change the way that we are
providing for the education of psychiatry and the treatment of
individuals with mental illness and/or substance use and/or
other conditions.
Mr. McLellan. If I could just contribute. I want to answer
as a scientist, and I want to answer as another guy who's in
the middle of a city, Philadelphia, and I don't want to leave
the hearing with this kind of bleak idea that there is nothing
that we can do. Just the opposite.
But I'll tell you. If you're really asking, as I ask myself
so often, how come I can't tell who's going to get this? How
come I couldn't stop it? How come I couldn't help one of these
young people that you're talking about? And I think science
tells us something there. You have a role as a neighbor. You
have a role as a parent. You have a role as a schoolteacher.
You have a role as a policeman, a health care provider. None of
those parts can do it by themselves, and that's what we've been
trying to do for too long. One of the things we've seen in
science and one of the ways we're trying to correct it is we
want to stop quite literally buying prevention and treatment
things that are just pieces of the real piece, of the real
effective element. We want to bring prevention-prepared
communities together, Baltimore, Philadelphia, everywhere,
where all of the parts are working together, all of the parts
are able to see these kids, not just when they start to use but
as other problems start to emerge. And we can do that, and it's
time that we do it. The last thing I want to leave you with is
another thing that is more hopeful and something we haven't
talked about. Yes, these illnesses are devastating. They're
terribly costly. They ruin lives. They ruin communities. But
there's hope. There are 20 million people now that label
themselves as being in stable recovery. So it is possible; and,
in fact, we think it's expectable. Treatment ought to lead to
recovery, and it can.
One of the reasons we're talking about medications and
brain science and bringing those things together is that, with
those new tools, we will make that number 40 million and
ultimately 60 million.
So I don't want to leave the hearing with kind of, oh, my
God, there is nothing we can do. We can do things, and this is
the time to do them.
Mr. Kennedy. I want to thank both of you for the great work
you do. My enthusiasm in questioning you is to get my point
across. And I can't thank you enough, Dr. McLellan, in trying
to get these State boards changed so we get more people in the
health care field knowledgeable so they can diagnose and treat
these illnesses.
And, Dr. Volkow, your, you know, great work over the years
in research has been so instrumental in moving it forward. I
look forward to continuing to work with you.
Thank you so much for your work, both of you.
Mr. Kucinich. Thank you very much, Mr. Kennedy and members
of the panel, for participating in this discussion and hearing
from our expert witnesses. This hearing is necessarily focused
on what kinds of medication might be available based on years
on research in neuroscience which would help to--that would
help people deal with their addictions. But I'm fully aware
that there are other ways and other therapies that could be
adjunctive and complementary. We have not really spent much
time discussing them today, although our witnesses have
acknowledged that they're looking at a broad spectrum approach
toward addiction and not advocating just one approach. Because
just one approach, if we're talking about drug therapy, would
immediately be a behaviorist approach which would be
mechanistic. If we're talking only about genetics, it tends to
be mechanistic. We get into stimulus response psychology. We
get into more of a behavior of psychology then opposed to
humanistic psychology. We get into a neuropsychiatric model as
opposed to something that maybe Menninger would have done years
ago looking at the bridge between science and religion, between
physics and metaphysics, into looking at the potential of the
human spirit for transformation.
Because there's another element here that we really haven't
probed at all and that gets out of the psychology of
victimization. That goes to what happens when someone does take
responsibility and maybe connects with spiritual principles in
their own life that helps them to transcend their dilemma. We
didn't get into that today, but, given this discussion, I think
at some point I think this subcommittee will.
I want to thank the witnesses, and we'll now move to the
next panel. I'm going to make the introductions right now. Mr.
Mike Mavromatis is a 48-year-old American who lives in
Columbus, OH. He owns a family restaurant in Columbus. He is a
husband, father of three, grandfather to two. He's an addiction
survivor, having recovered from an addiction to Vicodin, a
prescription pain medication. He serves on the board of
trustees at Central Ohio's oldest and largest sober club, which
hosts 20 12-step peer support meetings per week. He's also a
member of the National Alliance of Advocates for Buprenorphine
Treatment.
Welcome, and we appreciate your presence here.
Dr. Jeffrey Samet is a professor of medicine and public
health at Boston University School of Medicine and Public
Health. He's also vice chair for public health there.
Additionally, he's chief of the section of general internal
medicine at the Boston School of Medicine and Boston Medical
Center and medical director of the Substance Abuse Prevention
and Treatment Services for Boston Public Health Commission.
He's the director and president-elect of the American Board of
Addiction Medicine. His research addresses substance abuse in
HIV infection from health services behavior and epidemiological
perspectives.
Mr. Greg Warren is the President and CEO of Baltimore
Substance Abuse Systems. His organization directs the
prevention, treatment, and strategic planning for drug and
alcohol treatment of Baltimore City. The organization has
received awards and has been recognized nationally for its
innovative work in changing the way substance abuse is
delivered and financed in Baltimore City. Previous to BSA, he
was the director of Substance Abuse Treatment Services for the
Department of Public Safety and Correction Services for the
State of Maryland. In this role, he expanded substance abuse
treatment for incarcerated offenders.
Mr. Orman Hall, MA, has been the director of the Alcohol,
Drug Addiction, and Mental Health Services Board since 1989.
This board is responsible for planning, funding, and monitoring
all public behavior health services in Fairfield County.
Previously, Mr. Hall was a research and evaluation director for
the Tri-County Medical Health Board in Ohio and President of
the Ohio Association of Alcohol, Drug Addiction, and Mental
Health Services Boards.
Mr. Charles O'Keeffe is a professor in the Institute on
Drug and Alcohol Studies and the Departments of Preventive
Medicine and Community Health, and Pharmacology and Toxicology
at Virginia Commonwealth University. Previously, he was
President and CEO of Reckitt Benckiser Pharmaceuticals Inc.,
served in the White House for three Presidents as adviser,
special assistant for international health, and deputy director
for International Affairs in the Office of Drug Abuse Policy.
He served on U.S. delegations to the World Health Assembly and
U.S. Health Commission on Narcotic Drugs, was instrumental in
helping Congress reach consensus on the Drug Addiction
Treatment Act of 2000. Finally, Mr. Richard Pops, Chairman,
President, Chief Executive Officer of Alkermes; and he's
previously served as its Chief Executive Officer from 1991
through 2007. Under his leadership, Alkermes has grown from a
privately held company with 25 employees to a publicly traded
pharmaceutical company with more than 500 employees and two
commercial products. Mr. Pops currently serves on several
boards of directors, including Biotechnology Industry
Organization, the Pharmaceutical Research and Manufacturers of
America, and the Harvard Medical School Board of Fellows. This
is also a very distinguished panel and much appreciated to have
all of you be here for your testimony.
It's the policy of our Committee on Oversight and
Government Reform to swear in all witnesses before they
testify. I would ask that you rise, raise your right hands.
[Witnesses sworn.]
Mr. Kucinich. Let the record reflect that each of the
witnesses answered in the affirmative. As with panel one, I
would ask that each witness give an oral summary of your
testimony. Please keep the summary under 5 minutes in duration,
up to 5 minutes. Your complete testimony will be included in
the record of the hearing, and what you don't get a chance to
recite in your testimony, I assume that during the question and
answer period you'll be able to cover some of the points you
want to make.
So I would ask that we start with Mr. Mavromatis. You may
proceed.
STATEMENTS OF MIKE MAVROMATIS, MEMBER, ADDICTIONSURVIVORS.ORG;
JEFFREY SAMET, MD, MA, MPH, PROFESSOR OF MEDICINE, BOSTON
UNIVERSITY SCHOOL OF MEDICINE; GREGORY C. WARREN, MA, MBA,
PRESIDENT AND CEO, BALTIMORE SUBSTANCE ABUSE SYSTEMS, INC.;
ORMAN HALL, EXECUTIVE DIRECTOR, FAIRFIELD COUNTY OHIO ALCOHOL
DRUG ABUSE MENTAL HEALTH BOARD; CHARLES O'KEEFFE, PROFESSOR,
DEPARTMENTS OF PHARMACOLOGY & TOXICOLOGY/EPIDEMIOLOGY &
COMMUNITY HEALTH, INSTITUTE FOR DRUG AND ALCOHOL STUDIES, VCU
SCHOOL OF MEDICINE; AND RICHARD F. POPS, CHAIRMAN, PRESIDENT,
AND CHIEF EXECUTIVE OFFICER, ALKERMES, INC.
STATEMENT OF MIKE MAVROMATIS
Mr. Mavromatis. Chairman Kucinich and committee members,
thank you for inviting me to give testimony at this hearing.
It's obviously something that's very near and dear to my heart
and my family's.
I'm a father, a husband, a grandfather, small business
owner from Columbus, OH. Over the years, prior to 1999, I
served on many community boards, business associations, coached
sports, and so on. In 1999, while remodeling our family
restaurant, I sustained an injury. Didn't think much of it.
Couple months later, it didn't get much better. Visited the
family doctor. The family doctor proceeded to treat me with
Vicodin, starting with two tablets a day, one in the morning,
one in the afternoon. Over a 4-year period, that treatment
increased to basically 120 tablets every 12 days.
During my time with my doctor, I was always honest. I never
asked for more medication and relayed to him how I felt
honestly and earnestly.
How that changed my life. I became very withdrawn from my
family, business, life in general. My social life is gone. I
was no longer an active husband or parent, and I was caught in
a downward spiral. So, as with anybody, I tried to find out
what was wrong, what changed in my life. Obviously, it wasn't
old age only that was setting in or anything else. My weight
was increasing. So I went through the process of elimination,
and what it came down to was my chronic pain issues and how I
was being treated for it.
So I decided to stop the Vicodin, stop taking the Vicodin 1
day. And when I did that, within 5, 6 hours, I was in severe
withdrawal and the reality of my situation became very clear.
That transpired into a situation where I was trapped in a deep,
dark place by fear, guilt, and shame. I no longer had the
ability to freely choose.
Instead of being able to do the logical thing and seek
help, I tried to self-medicate. I went to 12-step groups. I
tried to detox myself from Vicodin. I tried to wean myself from
Vicodin. Each time I tried, I failed. My daily use increased
with each failure. And by the time I entered treatment in
February 2006, my use had increased from 120 Vicodin every 12
days to 100 or more every day; and I was spending up to
$130,000 a year to support that daily use. In 2006, when I
started treatment, my weight had increased from 1999 to 2006 to
305 pounds. I was passing blood in my urine; and, worst of all,
I was no longer a husband or a father. I was just a shell of
the person I used to be. To try and find solutions, because I
finally reached a point where this disease had brought me to my
knees, and I had to either find real solutions or just give up
and die, I started online, and online I found information about
Suboxone on a site, NAABT.org. Not only did I find the vital
medical facts I needed and overall educational material about
the disease of addiction, to which I was actually naive to
prior to this, they offered a doctor-patient matching system;
and through that system I was able to get in contact and begin
treatment with a local addiction specialist. This offered me
the opportunity to be treated with dignity and to continue my
life without needing to go away for 60, 90 days or whatever it
would take.
When I started the Suboxone, the induction process was
interesting, because after about 90 minutes, I felt as though I
had never had Vicodin before in my life. I felt no high or
euphoria sensations from Suboxone and honestly felt normal for
the first time in years. From there, through good instruction
and education and incorporating Suboxone into an overall
recovery program, a very encompassing recovery program----
[Bells sound.]
Mr. Kucinich. For those of you who are new to this Hill,
that means the House is about to enter into votes. So what I
will do is I'll hear testimony from Mr. Mavromatis and Dr.
Samet, and then we will take a break of about 30 minutes for
votes, and we'll come back and pick up where we left off. So as
soon as those buzzers stop ringing, you can proceed.
Mr. Mavromatis. Through taking Suboxone and implementing it
with a full and encompassing recovery program based on
education, understanding, and peer support, I was able to put
my life back together.
Now it has been 4 years and 4 months later, and I've had no
relapse, no desire. I'm back to being an active father,
husband, grandfather, and small business person in my
community. There are some that choose to debate whether the
addiction is truly a disease or simply a choice of action. I
ask them to look at the facts of what I have experienced. My
brain has been biologically altered. It may or may not totally
return to a pre-contraction state. Though I'm healed from this
disease in terms of putting it into remission, I will always be
susceptible to it. I will always have to live my life
differently with certain limitations and a more attentive
health regime. I will have to do this just as a person who
suffers from heart disease would, just as a person who suffers
from cancer or diabetes would. Over the past 4 years, I've had
the opportunity to work with other people like myself who have
experienced the same on a daily basis. Many of them are
veterans through our local VA and many online and in person. Of
those who have taken Suboxone and worked at the program
earnestly--and when I say that I mean within the confines of a
full and encompassing recovery program--the success has been
really, really well.
[The prepared statement of Mr. Mavromatis follows:]
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Mr. Kucinich. Thank you, sir; and thank you for your
courage in coming before a congressional subcommittee to
testify.
Mr. Mavromatis. I'm a little bit out of my water.
Mr. Kucinich. Your presence here is quite meaningful, and
your family and your community should be very proud of you
being here at this moment. So I thank you, sir. Dr. Samet, you
may proceed.
STATEMENT OF JEFFREY SAMET
Dr. Samet. Mr. Chairman and members of the committee, on
behalf of the American Society of Addiction Medicine [ASAM], I
welcome the opportunity to testify on pharmacotherapies for
substance use disorders.
ASAM is a national medical specialty society of more than
3,000 physicians. ASAM's mission is to increase access to and
improve the quality of addiction medicine and treatment. I am a
general internist with expertise in addiction medicine and a
professor at Boston University School of Medicine. I have
followed patients in primary care at Boston Medical Center
since the 1980's. In our urban primary care clinic, 400
patients with opioid dependence receive buprenorphine. In my
other role as medical director of the Boston Public Health
Commission's Substance Abuse Services, I oversee physicians who
work in the opioid treatment program and provide care to
approximately 400 patients who receive the medication
methadone. These medications enable patients to change their
lives for the better. These two medications are among a limited
number of pharmacotherapies available for the treatment of
addiction.
As physicians who care for patients with addictions, my
colleagues and I understand how critical effective treatments,
including medications, are for individuals with substance use
dependence. Addiction is a treatable chronic illness, as you've
heard; and treatment yields benefits, as you've also heard, for
individuals, families, and society.
Like other chronic diseases that I treat in primary care
such as diabetes and hypertension, medical management of
addiction may include medicines that are taken for prolonged
periods. These treatments we know improve patients' overall
survival, decrease drug use, decrease transmission of HIV,
decrease criminal activity, increase social functioning,
including employment and housing.
I provide direct patient care for approximately 50 patients
with opioid dependence. I have found biuprenorphine to be a
highly effective medication. Most patients, as you've also
heard, have found it to be transformative and transformative in
a good direction. We also manage the State hotline for those
looking for buprenorphine treatment and get calls, about 8 to
10 a day, from individuals across the State. Readily accessible
treatment for this condition is critical, as we are losing
about two people a day to opioid overdose in Massachusetts.
Buprenorphine and methadone are opioid agonists. Because of
their pharmacology, neither of these medications cause euphoria
in patients who are opioid dependent.
I realize that stories can sometimes convey the value of
our actions. One brief one, in 2003, a 20-year-old woman was
referred to one of my colleagues by her mom. Mom described the
daughter who had a heroin addiction, had experienced multiple
overdoses already, and had undergone multiple detoxifications.
The daughter was evaluated and begun on buprenorphine. She
started using with the assistance of the medication, attended
self-help meetings, and 7 years later has remained clean and
sober. In treatment, on treatment, graduated college with
honors and works full time in New York City now.
In September 2003, we started a collaborative care program
to provide buprenorphine treatment with our primary care clinic
to accommodate the large demand. Our model resulted in feasible
initiation and maintenance of buprenorphine for the majority of
our patients.
With this model and the support of the State to expand
treatment, buprenorphine is now provided in 14 community health
centers; and another 1,500 patients receive this truly life-
saving medication.
One challenge I have encountered with pharmacotherapy is
insurance discrimination. Some insurers simply refuse to pay
for addiction medications. We hope that once the Wellstone-
Domenici parity law is fully in effect this inequity will be
remedied. We also ask that Congress use its oversight authority
to see this law is enforced and individuals can access their
benefits promised to them under the law.
Unfortunately, there are fewer pharmacotherapies to treat
addiction today than there are for other chronic illnesses. For
my HIV-infected patients, compared to 1990 when we had one
medication, there are now more than 20. In 1990, there were
three medications to treat addictive disorders. Today, there
are five. That is an improvement but nowhere comparable to the
need. If we had more medications for addictive disorders, we
would be able to put them to good use.
In closing, thank you again for the opportunity to testify
today. Millions of Americans are living productive lives in
recovery, and you heard that before. We see it in our clinic.
ASAM remains committed to working with policymakers to ensure
that all Americans who need treatment are able to access it,
high-quality treatment services. Access to new
pharmacotherapies would be of great value in enabling us to do
just that.
[The prepared statement of Dr. Samet follows:]
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Mr. Kucinich. I thank the gentleman for his testimony.
We are going to recess here until approximately 12:30, at
which time we will resume with testimony from the rest of the
witnesses, and then we'll go to questions.
We will be in recess until 12:30.
[Recess.]
Mr. Kucinich. The committee will come to order.
Thank you for your patience while we conducted a series of
votes on the floor of the House of Representatives.
We're going to pick up where we left off and hear testimony
from Mr. Warren. You may proceed. Thank you.
STATEMENT OF GREGORY C. WARREN
Mr. Warren. Thank you, Mr. Chairman and members of the
committee, on behalf of Baltimore Substance Abuse Systems,
which is the funding, strategic planning entity that funds over
60 drug treatment programs in Baltimore City, treats 21,000
people, I appreciate sharing the story of what we've been able
to accomplish with medicated-assisted treatment, which is one
aspect of my talk.
The second is describe some of the experiences I had as
director of substance abuse treatment services for the State
prison system and how we can use medication-assisted treatment
to better link people into care upon release.
I was struck very much by the quality of the debate that
happened prior to the break, and there are some several key
philosophical approaches that I use in my work that I've
learned over the years of counseling people suffering from
addiction. And that is it is very, very important to take
advantage of that what I call motivational moment that an
individual has that says I have a problem and substance abuse
may be one of the root causes of it. That's the first piece.
The second is that recovery takes a long time. That phrase
``it takes a village'' is very, very true. What we've decided
to do in Baltimore is begin to change the way we even describe
treatment. We prefer a language that says continuity of care.
When someone comes into an emergency room because they have
liver pain, they then get into one type of substance abuse
care, transition to another type of substance abuse care, and
then transition to another type of substance abuse care. The
end result may be recovery coaches that aren't sponsors, aren't
counselors but really help that person better integrate into
society.
We think medication-assisted treatment is a significant
lever to helping improve the outcomes of the patients that we
see.
So just to back up for a minute, let me describe briefly
what is going on in Baltimore.
Baltimore is a population just up the street, 650,000
people, of which 12 percent suffer from substance abuse. We
have the unfortunate luxury of having heroin dominate the
admissions into treatment. So 67 percent of all admissions,
heroin is cited as the primary drug of choice. That has given
us the ability to develop unique intervention targeted to one
drug, one illicit drug, rather than being concerned about
evidence-based practices across a wider range of drugs.
In 2006--I was with the State prison system at the time,
but Dr. Josh Sharfstein, who is currently the Deputy Director
of the FDA, really thought of buprenorphine as a potential to
really make a difference in Baltimore City. So what was decided
to have create--and during my tenure we have expanded a great
deal--was to set up a public health response to an individual
disease.
So let me tell what you that means. It means that whether
you go into an outpatient program, into an ER, or into a
detention center, that you should have the option of
medication. The benefit of buprenorphine for us, which is
different than methadone, which we're a big supporter of, is
that we fund the substance abuse treatment for that individual
for the first 35 days. We stabilize that person in treatment on
average of 155 days.
At that point, the person has health entitlement benefits
and their urines are free--drug free--and they have begun to
really achieve some substantial milestones in terms of their
recovery. They then are transitioned to a continuing care
doctor.
So because of the comprehensive system of helping people
get insurance, stabilizing them in care, and then moving to
continuing care doctors, we're freeing up our financing and
we're also freeing up space within our treatment programs.
To illustrate this, when I took over the BSAS, we had 112
buprenorphine slots--spaces. We currently have 506. Now through
those slots we have transitioned over 3,000 people to
continuing care doctors who are getting their medications, you
know, and being treated for their other medical issues and
mental health issues in federally qualified health center and
primary care physician offices.
The best news of all is that 94 percent of those people,
those stable people that we've transitioned to continuing care
doctors, still remain in care after 6 months. So they now have
health insurance, they're stable, they are in active recovery,
and they continue to be in what we call a medical home, that
primary care physician that's going to help look after all of
their needs.
Some of the stories, particularly from the panelists to my
right, there are a great number of medical complications that
frequently are related to addiction; and to be able to get
someone placed in a place where all of those things can be
taken care of comprehensively is just such a significant
advantage.
We believe that the way we're incentivizing care today has
to fundamentally change. We currently fund episodic acute care.
What we're interested in doing is creating new funding
mechanisms that reward the referral, in other words, the
emergency room, the detention center, or the drug treatment
program to refer somebody to another type of substance abuse
care; and they should be financially incentivized as well. So
instead of just funding one place with four walls and a roof,
we want to fund the entire system and have the funding follow
the patient. That is our buprenorphine initiative in a
nutshell.
Let me switch very quickly to my work in corrections.
Prior to my starting at public safety in 2005, people
regularly died in our detention center and prison of overdose.
The single biggest period of overdose deaths is after someone
leaves an institution and they go back and try to use the same
dose of heroin that they did prior to their incarceration or
when they leave hospital stays. This is a significant challenge
in filling--sorry, significant challenge in causing stress with
correctional officers, institutions; and it is a public safety
issue within detention centers and prisons, which is illicit
drug use.
So, for us, what happened was in our detention center we
processed within Baltimore City about 85,000 people. We now
assess every single one of those people. Over 70 percent
readily self-report that they have an addiction problem. We
believe it is higher than that, but just that they would self-
report it is--that's a substantial benefit.
We now induce people on methadone and detox them with
methadone inside the detention center, and in the calendar year
before I left we detoxed 5,400 people using methadone and other
drugs. People who get arrested on methadone were historically
thrown off of their dose. We now maintain those individuals on
methadone while they're incarcerated so that if they do get
probation, if they are released on their own recognizance or
can make bail, they can return to the program without having to
go through withdrawal. This has saved lives in Baltimore City.
What we now plan to do in our next phase, which is one of
the reasons why we have to come on board in charge of Baltimore
City, is I need to increase the infrastructure to absorb heroin
addicts who come in because of a drug-related offense. We want
to induce them, start them on buprenorphine or methadone, and
have them leave the institution the same day, get medicated
upon release, which then takes the significant pressure of
withdrawal and the need to commit new criminal acts away from
them. We think in doing this we'll make a substantial impact on
the murder rate, crime, spread of HIV, and other things.
By the end of this fall----
Mr. Kucinich. Could you wrap up your testimony?
Mr. Warren. This fall, we'll have some research coming out
that will help us determine if we've saved money with health
care expenses deferred, recidivism rates, and otherwise.
Because we think we potentially have a story to tell. We just
need outside researchers to come in and help us tell our story,
rather than us trying to tell our own story.
Thank you for the opportunity to share.
[The prepared statement of Mr. Warren follows:]
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Mr. Kucinich. Thank you, Mr. Warren.
Mr. Hall.
STATEMENT OF ORMAN HALL
Mr. Hall. Thank you, Chairman Kucinich.
I am basically Mr. Warren's equivalent in Fairfield County,
OH, which is a mixed rural suburban community that is adjacent
to Columbus. To be completely honest, I'm rather amazed at how
common all of the themes are in terms of what people are
talking about here.
What I would like to discuss briefly is the scope of what I
believe may be the most profound public health problem that's
ever confronted our State and what I think are some potential
solutions to that problem.
First of all, in terms of the scope of the problem, in
2002, approximately 4 percent of those persons in treatment for
addiction disorders in Fairfield County were there for opiate
and heroin addiction problems. By 2008, we experienced a pretty
significant uptick. We were at 31 percent. Thirty-one percent
of those persons in treatment for addiction disorders in our
county were there because they had heroin or opiate addiction
problems. Last month--as of last month, almost 70 percent of
those persons in treatment for addiction disorders in Fairfield
County in rural suburban Fairfield County were there because
they were opiate or heroin addicted. In terms of criminal
justice statistics, 85 percent of our drug participants are
either addicted to heroin or opiates.
Last year, in 2009, we completed a jail utilization study
in conjunction with the sheriff's office that covered 2 years,
2003, which was at the beginning of the heroin and opiate
epidemic in our community, and 2008, which was toward the end.
In 2003, we estimated that the Fairfield County commissioner
spent about $350,000 incarcerating opiate addicts. By 2008, 52
percent of all jail days were accounted for by opiate addicts;
and the total cost was $2\1/2\ million. We also found that more
than 90 percent of those persons who were incarcerated for
opiate addiction problems were repeat offenders who had been in
jail on an average of 5 previous times.
Now how could this have happened in Fairfield County, OH?
Obviously, we have illicit pills coming up from Florida and
Kentucky, which is a serious problem. We also have heroin
coming down from Columbus. But one staggering statistic that
I've just recently been able to come up with I think
potentially explains most of our problem.
The Ohio Pharmacy Board reports that for the four-county
area of Fairfield, Athens, Hocking, and Perry Counties, a
region of 269,000 people, there were 13.9 million doses of
oxycodone and hydrocodone dispensed legally across all of those
residents. If every one of those 269,000 people received an
average dose, that would be 52 OxyContins, Percocets, and
Vicodins for every man, woman, and child that lives in
Fairfield, Athens, Hawking, and Vinton Counties.
If you include propoxyphene and tramadol among those drugs,
the numbers raise to 20.1 million, or 75 doses for every person
that lives in our area. Unbelievable.
What works. For those people who have crossed the line and
are now involved in our criminal justice system, we have found
that four things work: a combination of drug court, intensive
treatment, frequent random urine screens, and medication-
assisted therapy using Suboxone. Suboxone is incredibly
important from my perspective. It relieves craving without
euphoria, and it displaces other opiates from the receptors.
Now what has been our experience? In the first 2 years of
our drug court program that included all four of those elements
we were able to suspend 14,000 jail days at a savings of
$910,000 to our County. And, again, a combination of all of
those four things.
In closing, we are being overwhelmed in central and
southern Ohio. The number of opiate and heroin addicts is
staggering. We need more drug court capacity, we need more
treatment, and we need more Suboxone.
Thank you, sir.
[The prepared statement of Mr. Hall follows:]
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Mr. Kucinich. Thank you, Mr. Hall.
Mr. O'Keeffe.
STATEMENT OF CHARLES O'KEEFFE
Mr. O'Keeffe. Thank you, Mr. Chairman.
I will summarize my testimony here and request that my full
testimony be inserted in the record.
I had the privilege of working with the National Institute
on Drug Abuse in the Cooperative Research and Development
Agreement which resulted in the ultimate FDA approval of
buprenorphine or Suboxone for opiate dependence. This
successful industry-government collaboration has resulted in
the treatment of over 2 million people who might never have
been treated for opiate dependence without the successful
confluence of several factors.
In the late 1990's, under the leadership of then-Senator
Biden, Senators Levin and Hatch, then-Chairmen Bliley and Hyde
and Mr. Dingell, the Drug Addiction Treatment Act of 2000 was
enacted. This act, for the first time in nearly a century,
allowed effective agonist-based treatment for opiate dependence
in patients in the privacy of the offices and clinics of
qualified physicians.
These congressional leaders recognized the significant
inadequacies of the highly regulated closed-system addiction
treatment programs which had grown out of temporary
regulations, temporary fixes begun during the Nixon
administration and regularly expanded, often at the behest and
to the delight of many of the closed-system treatment providers
since that time.
These congressional leaders understood the stigma
associated with addiction. They recognized that, unlike cancer,
AIDS, diabetes, hypertension, there were no patient advocacy
groups to encourage better treatment. They recognized that,
despite the fact that nearly every one of us knows or is aware
of a family member or friend devastated by this disease, seldom
will we talk about it, much less advocate for better research
on its causes and treatments.
These congressional leaders recognized that the
pharmaceutical industry had little interest in spending scarce
research budgets for products for disease whose patients were
often unemployed or underemployed, often had no insurance and
no other medical coverage or ability to purchase these
products.
These leaders recognized that many rejected or failed to
fully comprehend the increasingly validated findings of the
scientific community related to this disease. They understood
that many believed that an addiction was simply irresponsible
behavior which should be punished. They recognized that some of
these same attitudes also permeated into the structures of
medicine, academia, and government. Yet, despite these
barriers, the leadership provided by the Biden, Levin, Hatch,
Bliley, Hyde, Dingell consortium insisted on better treatment.
Despite the reluctance, sometimes intransigence, of the
Food and Drug Administration, despite the expressed concerns of
the DEA, and despite the objections of entrenched commercial
interests, despite the clear lack of enthusiasm of ONDCP, the
106th Congress passed the Drug Addiction Treatment Act
unanimously in the Senate and 412 to 1 in the House. Thus began
a paradigm shift in the treatment of opiate dependence in the
United States, and we all relaxed, and that was a mistake.
The barriers to development of products to treat addiction
are still in place. Medications for addiction treatment are of
little interest to the pharmaceutical industry because there is
no incentive to commit scarce R&D funds to development of
products unlikely to provide a significant return on that
investment. The insufficiency of contract funds available to
the National Institute on Drug Abuse limits their ability to
engage in development activities suitable for FDA submissions.
The failure of FDA to take a position on what constitutes
efficacy in clinical trials for addiction is a major deterrent
to investment and research on these products. The stigma of
addiction and the fear of DEA leaves many physicians to avoid
treating this disease, despite the fact that many of their
patients suffer from it. Medical schools are providing
inadequate training and treatment for this disease. Stigma
prevents patients who suffer from it from seeking treatment.
Additional, and perhaps safer, medications for the
treatment of opiate dependence could probably be put in the
hands of qualified providers within a year, except for the
expressed lack of interest of the Food and Drug Administration
and the less-than-helpful interpretations of the Controlled
Substances Act by the DEA.
For the benefit of millions of patients who need addiction
treatment, I suggest that now is an appropriate time for the
Congress to consider options which might encourage the
commercial pharmaceutical industry to invest in research for
safe and effective treatment of an addictive disease. Among
those options which seem to me worthy of consideration by the
Congress are the following:
Some modification of the Orphan Drug Act to provide
exclusivity for products approved by FDA for this indication
without regard to patient numbers.
Perhaps a modification of section 524 of the Food, Drug and
Cosmetic Act, which was created last year by the FDA amendments
2 years ago of 2007, by authorizing the FDA to issue a priority
review voucher for addictive diseases or an exclusivity voucher
similar to one proposed by then-Senator Biden allowing a
sponsor of an approved addiction treatment product to transfer
a period of exclusivity to another marketed product.
And, finally, perhaps a modification of section 48D of the
Internal Revenue Code which would allow qualifying companies to
claim a tax credit or receive a grant for qualifying
therapeutic addiction treatment discovery projects.
Thank you, Mr. Chairman.
[The prepared statement of Mr. O'Keeffe follows:]
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Mr. Kucinich. Thank you.
Mr. Pops, you may proceed.
STATEMENT OF RICHARD F. POPS
Mr. Pops. Thank you, Mr. Chairman, distinguished Members.
Thanks for inviting me here today.
I am the CEO of a biotech company called Alkermes, with
about 600 employees, 300 of which are the Boston area and 300
of which are in Ohio. We as a biotech company are engaged in
the act of typically focusing on treatment of diseases that the
large pharmaceutical companies shy away from. In our case, this
includes the treatment of addiction. So it is really our real-
world experience as one of the few companies working to develop
medications in this area that brings me here today.
With original seed funding from NIDA, our scientists
created a drug called Vivitrol. Vivitrol is a once-a-month
medication. It is a nonaddictive medicine, administered by
injection once a month, which relieves the patient of the need
to take one or more pills one or more times a day. And, as you
may know, taking daily medication for patients with addictive
disorders is extremely difficult.
Vivitrol was approved by the FDA for the treatment of
alcohol dependence in 2006, and with that approval in hand then
we set out on a research program to demonstrate Vivitrol's
potential of utility and treatment of opiate dependence as
well. That was very successful from a clinical standpoint, and
we're hoping for FDA approval in this indication later this
year.
We began our work at the molecular level by trying to
understand the neuroscience behind addiction. With our
successes in the lab and in the clinic, we end up here in
Washington with you with a deep interest in advancing the
public policy so that our innovations actually get to patients.
You're aware of the statistics. I won't repeat many of
them, but they are staggering. Millions of Americans with
addiction are unserved or untreated and don't have access to
important treatment options.
If you compare the use of medicine for the treatment of
depression to that of alcohol dependence, it is instructive.
The rate of medication prescribed per covered life for
depression is almost 1 in 10 for antidepressants, and that
compares to alcoholism to less than 1 in 5,000.
The system in the U.S. bearing the largest economic and
public safety brunt of alcohol addiction is criminal justice,
where 40 percent of all violent crimes involve alcohol; and,
despite this prevalence, over 80 percent of addicted offenders
fail to receive treatment for their disease.
So in addition to this being bad medicine, it is bad
economics. These untreated patients are costing the system
billions of dollars, as you know. That might have been
understandable 30 years ago when the scientific understanding
of the addicted brain was at its infancy. But today, knowing
what we know about the neuroscience of addiction, failure to
use medicines is inexcusable.
With the FDA now having approved medications based on
rigorous demonstration of their safety and their efficacy and
with the NIH and the Institute of Medicine calling for their
use in combination with counseling, it is now time for society
to begin to treat substance abuse as the disease that it is.
This work at Alkermes has become very real to us. We
receive letters and stories from patients who have benefited
from the use of Vivitrol as part of their treatment program.
They are incredibly moving, and they are a driving motivation
within our organization. But we are definitely the minority.
The treatment of addiction is not a mainstream pharmaceutical
market, as you've heard. None of the largest pharmaceutical
companies sell products for the treatment of addiction, but I
believe this can and will change.
Government can help. In fact, I believe the government
policy changes are likely necessary to solidify the development
of new medications for alcohol and drug addiction.
We have specific recommendations that we summarize in the
written testimony, but, in a brief nutshell, there are simple
and powerful things that can be done:
First, simply implementing established treatment standards
like those of the National Quality Forum and making them a
condition to participating in public and private programs would
be a huge step forward. These standards exist.
No. 2, providing grants and incentives for States to assist
them with establishing addiction pharmacology programs.
Third, simply using performance-based metrics like you hear
about in Baltimore and Ohio to fund programs that work and
accredit providers who use those that work.
And then, finally, an even more aggressive idea similar to
what you did with vaccines is to jump-start the market with
guaranteed minimum purchase orders for a limited period of
time.
These kinds of initiatives represent ways that government
leadership can help patients gain access to effective
medications, create incentives for companies to invest in R&D,
and avoid the huge costs of nontreatment of these patients.
So I'll finish there. We really do believe that State and
Federal Government can play a role here and begin to bring the
promise of the modern pharmaceutical research that we do in our
company and other companies, bring that to the treatment of
addiction.
Thank you again.
[The prepared statement of Mr. Pops follows:]
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Mr. Kucinich. Thank you.
We're going to move on now to questions of second panel. I
would like to begin with Dr. Samet.
Some in the substance abuse treatment field reject the use
of addiction medications as substituting one drug for another.
What is your medical opinion about this?
Dr. Samet. Medications for addiction can be of the type
that are agonists to the receptors, where the term of
substituting the drug or not, often antagonists, the evidence
is that both types of medications are effective. But that's the
data. To say otherwise I would say is the entering of stigma
into the evidence for treatment.
Mr. Kucinich. And so how do we destigmatize addiction and
bring it into mainstream medicine? How can we do this in a way
that gets the benefit of medications in the way other chronic
diseases are able to do that?
Dr. Samet. I think we can do it by pushing the concept of
evidence-based medicine. I think that's happening. I think when
I began on faculty of the medical school 20 years ago, it
seemed like a distant goal. I think it's happening right now.
So what you're saying needs to happen is happening. It just has
to be accelerated. It's very possible. We have seen it.
Mr. Kucinich. Now, Mr. Warren, you testified that the total
annual cost to operate the Baltimore Buprenorphine Initiative
for 2009, including funding for medications, outpatient
counseling, physician, nursing, treatment advocate staff, that
total was $2.8 million. It seems like a lot of money. You
testified that with the use of buprenorphine you have reduced
the period of stabilizing patients and transferring them to
outpatient programs from 281 days to 155 days, enabling you to
treat more patients. So is this program cost effective?
Mr. Warren. We have found it to be hugely, hugely cost
effective. For us to maintain that particular person on their
medication and in treatment forever and ever and ever would be
mind-numbing financially. What we're able to do, though, is
realize what is out there now in the health care system,
utilize a block grant to fund people who are truly uninsured,
help them get insurance. And then once they get medical
assistance they then move to that pool of funding, which the
State of Maryland then brings in $0.61 for every $1. So, for
us, we're able to treat three to four times as many people than
historically we would simply because we're trying to optimize
the public health system to the fullest.
Mr. Kucinich. Now, Mr. Hall, has Fairfield County, OH,
found it cost effective to pay for these medications as part of
a drug court program? And have you been able to reduce the
incarceration costs that skyrocketed in your county as a result
of the opiate addiction epidemic?
Mr. Hall. Chairman Kucinich, we've been hit by a tidal wave
of opiate addiction in central and southern Ohio.
The initial----
Mr. Kucinich. Let me just stop you there. Why? I mean,
besides from the obvious, why?
Mr. Hall. I can speculate. I think it really goes back to
three things. We have a tremendous number of opiates coming up
from Florida and Kentucky and Portsmouth, OH. We have heroin
from Mexico coming in from Columbus. But, from my perspective,
the big problem is an unsuspecting health care community that
is just inundating our part of the State with unnecessary and
inappropriate levels of prescription painkillers. Again, 13.9
million doses of oxycodone and hydrocodone products across a
population of 269,000 people. That's 52 doses for every man,
woman, and child that lives in those four counties. It is
staggering. I think it is the tip of the sword.
Mr. Kucinich. And who's consuming these.
Mr. Hall. I'm sorry.
Mr. Kucinich. Who's consuming these?
Mr. Hall. I think we probably have--I think we could have--
--
Mr. Kucinich. It is not every man, woman, and child. So
who's consuming them?
Mr. Hall. I think we have probably several thousand people
in our area in Fairfield County maybe that are opiate addicted
that still aren't known to our system.
Mr. Kucinich. So somebody who is opiate addicted, how many
of those might one addict take in a day?
Mr. Hall. Well, you know, that's a good question; and
probably clinical experts could answer that better than me. But
what I do know from discussions with a good friend of mine, Dr.
Philip Pryor, an addictionologist, said that as human beings we
have an almost unlimited ability or capacity to tolerate
opiates.
If you look at the tolerance levels for alcohol, the ratio
is about four to one. An early stage alcoholic can drink about
a six-pack a day and get what they need. A late stage alcoholic
may drink a case.
But if you look at opiate addiction, an early stage opiate
addict may use 60 milligrams a day, but a late stage opiate
heroin addict may be using the equivalent of 1 to 2,000
milligrams of heroin. That's a 70-to-1 ratio.
Mr. Kucinich. Mr. Mavromatis, can your personal experience
shed some light on this in terms of volume of a particular
drug?
Mr. Mavromatis. If you look at the shorter-acting opiates
that are pharmaceutical like Vicodin, Percodan, Percocet,
things like that, the range is pretty broad. But it can be
anywhere from 20, 25 tablets per day to what I was consuming,
you know, up to 100 or more.
Mr. Kucinich. Twenty-five tablets of what dose?
Mr. Mavromatis. Five milligram to ten milligram.
Mr. Kucinich. When you were moving into this addiction,
were you aware that you were doing that?
Mr. Mavromatis. No. Nope. You know, it was a slow and
unsuspecting process. I went to the doctor. I did everything
the doctor asked me to do. I was always honest with the doctor.
And my decline in life, I guess my personal life, my emotional
life was slow, too. I would slowly become--I was slowly
becoming detached from my business, from my family, from my
community, from things that I always did, things that I loved
to do.
And what I didn't realize at the time is my body's building
a tolerance. So when the doctor asked me, Mike, how do you
feel? Well, Doc, I feel pretty good, but the sciatic nerve is
starting to act up again. And there went the process, until I
realized I had a problem.
Mr. Kucinich. During that period, you said you put on
weight. So you ate more. It increased your appetite. Is that
right? Or did you just put----
Mr. Mavromatis. I don't think it was so much Mike likes to
eat, and being in the restaurant and being Greek, obviously.
But I don't think it was that. I think it was being detached,
you know. Slowing down. Instead of spending 14 hours in the
business 6 days a week, you know--what I mean it was a slow
decline. Instead of coaching three junior high school sports,
all of a sudden you're coaching one.
Mr. Kucinich. So it was withdrawal from work.
Mr. Mavromatis. Exactly. A withdrawal--a withdrawal from
normalcy I guess is a good way to describe it. And by the
winter of 2003, 2004, when I decided, you know, you have a
problem and you need to start figuring out what it is, so I
started the process of elimination, what has changed, you know,
my weight increased up to somewhere between 255, 265, something
like that. And that's when I decided, you know, it has to be
the medications you're taking, so stop taking them. And that's
when reality hit me in the face.
Mr. Kucinich. Back to Mr. Hall, tell me more about the
extraordinary level of consumption of these opiates that is
going on. Talk to me more about that.
Mr. Hall. To be completely honest, Mr. Chairman, the data
that we have is still unfolding. I don't know that we can
estimate within any clear sense how many people there are in
our county that are affected, given the tolerance ratios. We
fear there could be several thousand people in Fairfield County
alone. We know that there are many counties to the south of us
that have even worse problems than we----
Mr. Kucinich. Are you laying the groundwork for
epidemiological studies or for longitudinal studies that would
try to see any other markers or indices that would reflect upon
on this staggering amount of drug use?
Mr. Hall. Yes, sir. We desperately need that kind of work.
We conducted some opinion surveys in our county that are also
quite disturbing. A survey of 350 Fairfield County adults
indicated that around 78 percent of the people that responded
were aware of someone in their immediate family or among their
friends that had received an opiate prescription within the
past year. Twenty-two percent were aware of someone that was
using an opiate painkiller without a prescription. So it
appears to me that the problem is fairly widespread in our
area, and those counties immediately to the south of us appear
to have a bigger problem than we do.
Mr. Kucinich. And these are prescriptions, as opposed to
black market?
Mr. Hall. I think it is a mix. It's hard to discern the
degree to which they are prescription prescribed as opposed to
coming in illicitly.
What we do know, there is an anesthesiologist in our
community that's beginning to do some research about diversion;
and he believes that among those patients in his practice that
are receiving opiate prescription that maybe as much as 20
percent of those prescriptions are being diverted for illicit
use.
Mr. Kucinich. Let me ask Mr. Mavromatis again. As you were
sliding into this addiction, what kind of feeling did you get?
What did these opiates do for you?
Mr. Mavromatis. That's what was deceiving. I was taking--
prescribed Vicodin for pain, and I took it. And other than
helping me with the pain, I didn't have any other sensation. I
didn't have a high sensation.
You know, when I was young, fresh out of high school and
you'd go out and have a few drinks and have a good time or
whatever you might partake in, I knew what feeling high was.
Mr. Kucinich. So for you this wasn't about getting high. It
was about what? Pain relief?
Mr. Mavromatis. Oh, absolutely. I had injured myself
remodeling our restaurant, and I had done damage to the L5 disk
in my back, and that's been a slow progression.
Mr. Kucinich. So if you took the drug, you didn't have
pain. But you kept taking it, and you got addicted.
Mr. Mavromatis. Right. And as I would--time would go on.
Evidently, the tolerance to the medication would build, so the
pain would start to creep back in. The doctor says, Mike, how
are you feeling? I'd tell him honestly either I was great or,
Doc, the pain--the sciatic nerve is starting to act up again,
or I'm having trouble with getting up with muscle spasms or
aches in the middle of the night or whatever. So up the dose.
Mr. Kucinich. This discussion--in a previous panel, we got
into this, too, with Mr. Kennedy. So getting into the area of
effective pain management, nonnarcotic approaches, if they can
be effective, nonnarcotic, nonaddictive approaches. Pain
management is a whole area of medicine that I suppose needs to
be mindful of the kind of discussion we're having today.
Someone had his hand up. Mr. Warren, do you want to enter
into this discussion?
Mr. Warren. This issue of what's driving the drug trade.
Prescription drugs was sort of the interchange that I wanted to
respond to. We have a very large market--it's well-known--
Lexington Market in Baltimore City, and it is an area of our
city that numerous high-profile individuals want to redevelop.
And so the theory was that, well, there are methadone clients,
buprenorphine clients that are going there and selling their
drugs and that's why you have an open air drug market around
that market.
Well, what we did was, for 6 months, we monitored who was
arrested at that market and at the same time looked at who
showed up at the detention center. And so what we found was
that a minuscule 2, 3 percent of people being arrested were in
drug treatment. They were not there selling their methadone or
selling their buprenorphine.
What were there was people were selling prescription, full-
agonist drugs, the Percocet, Percodan, Vicodin. And where they
got those prescriptions is up to conjecture. My hunch is they
were taking from the grandmother, their parents, their
relatives' medicine cabinets and going down and selling some of
that prescription drugs that people take for legitimate pain
medication.
And there needs to be a significant position awareness
campaign that they need to improve their monitoring of the
prescriptions that they are giving to individuals, because that
is what was driving the drug trade in this particular area of
Baltimore City.
Mr. Kucinich. Mr. O'Keefe and Mr. Pops, how critical was
the NIH funding in support to both your companies' development
of Suboxone and Vivitrol? Is there a strong case for continued
Federal funding and research on medications' development to
create progress in this area? Mr. O'Keefe.
Mr. O'Keeffe. It was absolutely critical for Suboxone. It
would not have happened without research from NIDA. A series of
things had to happen. There had to be some exclusivity, there
had to be approval by the FDA, and there had to be funding from
NIDA.
Mr. Kucinich. Before we go to Mr. Pops, I just want to ask
you as a followup, you stated that the failure of the FDA to
take a position on what constitutes efficacy in clinical trials
for addiction is a major deterrent to investment and research
on these products.
Mr. O'Keeffe. It is a major deterrent. FDA has not decided
yet how they want to measure the efficacy of drugs.
For example, if a pharmaceutical company had a new product
for the treatment of opiate dependence--well, opiate dependence
may be a different story. Let's look at something for which
there is no treatment, like methamphetamine.
The FDA cannot yet decide whether a reduction in use of
methamphetamine is a measure of efficacy or whether total
abstention from methamphetamine is the mark that they would put
on the chart for efficacy. And until that happens no
pharmaceutical company is going to spend a great deal of money
if they don't know what the end is for them to research.
So that's one of the major problems of deterrence to
development to interest the pharmaceutical companies.
Mr. Kucinich. Mr. Pops.
Mr. Pops. So, similarly, the NIDA funding was important.
NIDA had been calling for literally 30 years for the
development of a long-acting injectable from of an opiate
receptor antagonist. And it really took until our technology
became available for us to make that happen.
So the seed funding was important, but it is important to
recognize the bigger question. We probably had to come up with
another couple hundred million dollars on top of that to
develop the drug. And I would say that, today, NIDA's voice
amplifying and underscoring the importance of the data that
resulted from clinical trials is extremely important at this
moment. So it wasn't just at the beginning. It was throughout
the entire process based on the quality of the data being
researched.
Mr. Kucinich. Thank you.
Dr. Samet, our subcommittee has found and Mr. O'Keefe
testified that one of the reasons doctors are hesitant to treat
patients who are addicted to drugs with medications is because
of the scrutiny it brings from the Drug Enforcement Agency,
which regulates opiate-based medications. Have you found this
to be true in your work, in your involvement with the American
Society of Addiction Medicine?
Dr. Samet. Actually, I'm probably one of the few docs who
had the DEA come by and say, we want to check what you're
doing. I think it's likely more perception than reality. Docs
are concerned because DEA can make your life difficult. But
docs who are using Suboxone and fairly established, agreed-upon
approaches with patients, in truth don't have a lot to worry
about, would be the way I'd put it.
I can speak from my one situation where what they asked for
we gave them. They said good work. But there's that perception.
Mr. Kucinich. Is there any--I just want to go down the line
here, starting with Mr. Mavromatis. Is there anything that
you'd like to say to the subcommittee for the record with
respect to the direction that you think we should be taking and
looking at for the purposes of having a more effective national
drug policy, Mr. Mavromatis?
And then we'll go right down the line. It will just take a
minute.
Mr. Mavromatis. Thank you.
I view Suboxone as the example, because that's what I know.
With Suboxone, unlike the older recovery medications, you
actual have a medication that is proactive and productive and
fosters and lends itself to recovery. Yet it has restrictions
on it that are counterproductive.
So when I go to help people or my peers, so to speak, find
doctors and find help, it's not there. You know, a doctor
prescribing Suboxone can only prescribe to 100 patients. And
then when I look at it in what people are paying--in our area,
in Columbus, we're blessed to have a lot of doctors
prescribing. In other parts of Ohio, for instance, where there
aren't any, the expense is night and day. Competition brings
the price down. I think there is like, overall, maybe 1 percent
doctors willing to prescribe.
So I think my feeling, from my point of view, is if--
whatever you do, use the gains we now have, and we're going to
have more, with medical science to be more productive and more
proactive and take that education and group it, blend it with
the education of old, the peer support, the spiritual, and all
that, so we're moving forward. Instead of doing little things
that with each step we take forward we're backing up a step or
half step, so----
Mr. Kucinich. Thank you.
Dr. Samet.
Dr. Samet. Thank you for the opportunity to reflect on
that. I think that, with more medications available to treat
addictions, more patients will be treated. A few medications
can treat a sizable number. The more you have, the more options
to include those patients who don't succeed the first time
around.
But that will also require training physicians and nurses
to know how to treat patients for these problems, to understand
these problems. It hasn't been traditionally part of the
curriculum, but it is becoming, and that needs to be
encouraged.
Finally, because, as you heard from Dr. McLellan, the
substance use treatment system began independent of the medical
system, more coordinating care between that system and the
medical system is critical, both communication at every level--
and, really, the time has come to make the treatment of
addiction a mainstream medical issue, in part so that we help
people with those problems and in part so that we can treat
everything else that's going on. Because if we don't, that's
not possible.
Mr. Kucinich. Thank you.
Mr. Warren.
Mr. Warren. Thank you for the opportunity to share in this
important point.
I would say three things. First, buprenorphine has enabled
us to establish relationships with other parts of the health
care system that heretofore we've had no contact with, FQHCs,
hospitals, primary care physicians. It creates, I believe, the
foundation of learning that we'll need when national health
care reform hits in 2014 and beyond.
The second thing that I think really needs to be stressed
about Suboxone is Suboxone doesn't cure anybody. It simply
provides the opportunity to help. It provides us the leverage
to make amends for bankrupt educational systems, social support
networks, and so forth that need to be created for these
individuals that have never had this support before; and it
gives us the time to develop it. That's the important thing.
The second piece is if we want to make a difference in
crime in this country, we have to realize that drug addiction
drives crime. If we can offer an intervention that allows--in
the conversation I had with our police commissioner the other
day, he said, the two biggest things you could give a police
officer would be here is a card you can give somebody to get a
job and here is a card to give somebody to get help for their
drug treatment. The people who cause us the most angst in the
communities in which we live are the people suffering from
addiction. Creative uses of drug court, detention centers in
the prison system to help people I think would make a big
difference.
I started a therapeutic community in one institution. I
went to graduation. This gentleman came up to me and said, hey,
the last 6 months have been great. I've learned so much. But,
listen, I know I'm about to be released in about a week. I need
medication-assisted treatment or else I will go right back.
They need that support to reinvigorate their lives. So
medication isn't just a treatment. It is a good opportunity for
a whole variety of reasons.
Mr. Kucinich. Thank you.
Mr. Hall.
Mr. Hall. Yes, Mr. Chairman. I believe what is going on in
central and southern Ohio is a signal for a national emergency.
I think that opiates are probably the most addictive substance
known to man and that without a multilayered approach we're
going to have hundreds of thousands of people in prison
unnecessarily and dying way too early.
Again, I think we need to take a multilayered approach to
this problem that includes things like drug court, intensive
outpatient therapy, and medication-assisted therapy. I'm
personally familiar with Suboxone. I think it has made a
profound difference in our community. We need more of those
things to combat this problem.
Mr. Kucinich. Mr. O'Keefe.
Mr. O'Keeffe. Mr. Chairman, we've heard a great deal about
the success and the advantages of Suboxone in treatment for
patients. I mentioned in my testimony the concerns about the
Drug Enforcement Administration and the fear of the Drug
Enforcement Administration.
As an example, back in July of last year, the Drug
Enforcement Administration sent a letter to all physicians who
were qualified to use buprenorphine for the treatment of opiate
dependence. Now they simply said, to accurately plan for and
properly allocate resources effectively and efficiently, we are
attempting to discern whether or not the data-waived physician
portion of your medical practice will need to be inspected. The
letter was viewed to be fairly threatening by many physicians,
and physicians objected to it.
It in fact also included a request for information and a
form which was never approved by OMB. And after objections by
physicians, the DEA--and the ONDCP--the DEA agreed that they
would send out a letter clarifying.
That clarifying letter said, speaking of the earlier
letter, that letter was not intended to discourage or limit
treatment services or imply that inspections were somehow the
result of targeting for individual activity. If a practitioner
chooses to return their DEA-waived registration to DEA due to
inactivity, DEA would simply remove that practitioner from our
regulatory inspection program. Such action would prevent
unnecessary onsite visits and enable DEA to employ its
resources more efficiently.
Most physicians took that is an invitation to turn in their
right to prescribe Suboxone. As a result of that, of the 18,000
physicians in the United States who were at that time able to
prescribe buprenorphine, 676 of them voluntarily returned their
registrations to the Drug Enforcement Administration, resulting
in 67,000 patients who were denied treatment. Because each of
those could prescribe for 100 patients.
These are exactly the kind of physicians that we're trying
to recruit into the program. We want the physician who is
treating only one or two patients to be able to treat that
patient. But so long as they are threatened by the DEA they
have no intention of opening themselves to an inspection by a
gun-toting DEA agent for the treatment of one or two patients.
So I think it is a real deterrent. The DEA is a deterrent,
significant deterrent.
Mr. Kucinich. Thank you.
Mr. Pops, proceed.
Mr. Pops. First of all, hearings like this one today are
very important. So thank you very much for your leadership on
this.
I was moved personally by Congressman Kennedy's remarks.
This idea that we tolerate suboptimal outcomes in the treatment
of this disease while patients go to treatment facilities,
quote, unquote, and receive suboptimal care is a travesty.
So, as I said in my earlier comments, simply collecting
data on the outcomes that one gets with Suboxone or Vivitrol
and publishing that data and disseminating it and holding
people to these standards would be a really important role the
government can play.
And then I also would amplify the comment about returning
servicemen and women and veterans. Biotechnology drugs in
general are often not on the VA formulary; and so the benefit
of all of this modern research, which we really are the leaders
in the world here in the United States, is often is not
translated into the people who protect us, and I think it is a
mistake.
Mr. Kucinich. I want to thank each and every one of the
panelists.
This has been a hearing that will lead us into the next
series of hearings that we're going to have on national drug
policy. This subcommittee is charged with responsibility for
oversight over national drug policy and for making
recommendations. So I want to thank you for the role that
you're playing in helping the veterans form, the members of
this committee, the subcommittee, and the Members of Congress
as to the directions that we might take that would be more
effective for the individual who is struggling with an
addiction and for the society at large.
I'm Dennis Kucinich, chairman of the Domestic Policy
Subcommittee of the Oversight and Government Reform Committee.
The title and topic of today's hearing has been Treating
Addiction As a Disease: The Promise of Medication Assisted
Recovery. This subcommittee will continue to work in this area
and look at a variety of treatments and to support those that
are working to try to meet the challenge and discourage
addictions.
Thank you, gentlemen. There being no further business
before this subcommittee, stand adjourned.
[Whereupon, at 1:41 p.m., the subcommittee was adjourned.]
[The prepared statement of Hon. Diane E. Watson and
additional information submitted for the hearing record
follow:]
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