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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

(II)

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

EDOLPHUS TOWNS, New York, Chairman

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

JIM COOPER, Tennessee

GERALD E. CONNOLLY, Virginia

MIKE QUIGLEY, Illinois

MARCY KAPTUR, Ohio

ELEANOR HOLMES NORTON, District of

Columbia

PATRICK J. KENNEDY, Rhode Island

DANNY K. DAVIS, Illinois

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

DARRELL E. ISSA, California

DAN BURTON, Indiana

JOHN L. MICA, Florida

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

BRIAN P. BILBRAY, California

JIM JORDAN, Ohio

JEFF FLAKE, Arizona

JEFF FORTENBERRY, Nebraska

JASON CHAFFETZ, Utah

AARON SCHOCK, Illinois

BLAINE LUETKEMEYER, Missouri

ANH ‘‘JOSEPH’’ CAO, Louisiana

BILL SHUSTER, Pennsylvania

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

JOHN F. TIERNEY, Massachusetts

DIANE E. WATSON, California

JIM COOPER, Tennessee

PATRICK J. KENNEDY, Rhode Island

PETER WELCH, Vermont

BILL FOSTER, Illinois

MARCY KAPTUR, Ohio

JIM JORDAN, Ohio

DAN BURTON, Indiana

MICHAEL R. TURNER, Ohio

JEFF FORTENBERRY, Nebraska

AARON SCHOCK, Illinois

BILL SHUSTER, Pennsylvania

JARON R. BOURKE, Staff Director

(III)

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

(1)

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, reVerDate 11-MAY-2000 14:52 Jun 09, 2011 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65132.TXT KATIE PsN: KATIE
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ducing 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

3

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

7

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

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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 parttime 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.

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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

19

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.

31

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 nearterm 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.

32

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 treat- ment 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

33

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

34

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 merrygo-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

35

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 selfmedicate 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.

36

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

37

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 21⁄2 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.

38

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.

39

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.

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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

41

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.

42

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

43

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

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cause 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?

45

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.

46

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 MitchVerDate 11-MAY-2000 14:52 Jun 09, 2011 Jkt 000000 PO 00000 Frm 00050 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65132.TXT KATIE PsN: KATIE
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ell, 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

48

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.

49

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

50

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 proVerDate 11-MAY-2000 14:52 Jun 09, 2011 Jkt 000000 PO 00000 Frm 00054 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65132.TXT KATIE PsN: KATIE
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ceeded 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

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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

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ready, 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 HIVinfected 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.

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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

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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 $21⁄2 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.

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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

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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 combinaVerDate 11-MAY-2000 14:52 Jun 09, 2011 Jkt 000000 PO 00000 Frm 00104 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65132.TXT KATIE PsN: KATIE
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tion 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

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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.

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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.

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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, fullagonist 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

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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

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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.

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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.

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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 DEAwaived 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.

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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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