    [House Hearing, 114 Congress]
    [From the U.S. Government Publishing Office]

        COMBATING THE OPIOID ABUSE EPIDEMIC: PROFESSIONAL AND ACADEMIC
                                  PERSPECTIVES

    =======================================================================

                                    HEARING

                                   BEFORE THE

                  SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                        ONE HUNDRED FOURTEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                 APRIL 23, 2015

                                   __________

                               Serial No. 114-34

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

          Printed for the use of the Committee on Energy and Commerce

                            energycommerce.house.gov
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                        COMMITTEE ON ENERGY AND COMMERCE

                              FRED UPTON, Michigan
                                     Chairman

    JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
      Chairman Emeritus                    Ranking Member
    ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
    JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
    JOSEPH R. PITTS, Pennsylvania        ELIOT L. ENGEL, New York
    GREG WALDEN, Oregon                  GENE GREEN, Texas
    TIM MURPHY, Pennsylvania             DIANA DeGETTE, Colorado
    MICHAEL C. BURGESS, Texas            LOIS CAPPS, California
    MARSHA BLACKBURN, Tennessee          MICHAEL F. DOYLE, Pennsylvania
      Vice Chairman                      JANICE D. SCHAKOWSKY, Illinois
    STEVE SCALISE, Louisiana             G.K. BUTTERFIELD, North Carolina
    ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
    CATHY McMORRIS RODGERS, Washington   KATHY CASTOR, Florida
    GREGG HARPER, Mississippi            JOHN P. SARBANES, Maryland
    LEONARD LANCE, New Jersey            JERRY McNERNEY, California
    BRETT GUTHRIE, Kentucky              PETER WELCH, Vermont
    PETE OLSON, Texas                    BEN RAY LUJAN, New Mexico
    DAVID B. McKINLEY, West Virginia     PAUL TONKO, New York
    MIKE POMPEO, Kansas                  JOHN A. YARMUTH, Kentucky
    ADAM KINZINGER, Illinois             YVETTE D. CLARKE, New York
    H. MORGAN GRIFFITH, Virginia         DAVID LOEBSACK, Iowa
    GUS M. BILIRAKIS, Florida            KURT SCHRADER, Oregon
    BILL JOHNSON, Ohio                   JOSEPH P. KENNEDY, III,
    BILLY LONG, Missouri                 Massachusetts
    RENEE L. ELLMERS, North Carolina     TONY CARDENAS, California
    LARRY BUCSHON, Indiana
    BILL FLORES, Texas
    SUSAN W. BROOKS, Indiana
    MARKWAYNE MULLIN, Oklahoma
    RICHARD HUDSON, North Carolina
    CHRIS COLLINS, New York
    KEVIN CRAMER, North Dakota

                                     ____

                  Subcommittee on Oversight and Investigations

                            TIM MURPHY, Pennsylvania
                                     Chairman
    DAVID B. McKINLEY, West Virginia     DIANA DeGETTE, Colorado
      Vice Chairman                        Ranking Member
    MICHAEL C. BURGESS, Texas            JANICE D. SCHAKOWSKY, Illinois
    MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
    H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
    LARRY BUCSHON, Indiana               JOHN A. YARMUTH, Kentucky
    BILL FLORES, Texas                   YVETTE D. CLARKE, New York
    SUSAN W. BROOKS, Indiana             JOSEPH P. KENNEDY, III,
    MARKWAYNE MULLIN, Oklahoma               Massachusetts
    RICHARD HUDSON, North Carolina       GENE GREEN, Texas
    CHRIS COLLINS, New York              PETER WELCH, Vermont
    KEVIN CRAMER, North Dakota           FRANK PALLONE, Jr., New Jersey (ex
    JOE BARTON, Texas                        officio)
    FRED UPTON, Michigan (ex officio)

                                      (ii)

                                 C O N T E N T S

                                  ----------
                                                                       Page
    Hon. Tim Murphy, a Representative in Congress from the
      Commonwealth of Pennsylvania, opening statement................     1
        Prepared statement...........................................     4
    Hon. Diana DeGette, a Representative in Congress from the State
      of Colorado, opening statement.................................     6
    Hon. Marsha Blackburn, a Representative in Congress from the
      State of Tennessee, opening statement..........................     7
    Hon. Janice D. Schakowsky, a Representative in Congress from the
      State of Illinois, opening statement...........................     8
    Hon. Paul Tonko, a Representative in Congress from the State of
      New York, opening statement....................................     9

                                   Witnesses

    Robert L. DuPont, M.D., President, Institute for Behavior and
      Health, Inc....................................................    11
        Prepared statement...........................................    13
        Answers to submitted questions...............................   105
    Marvin D. Seppala, M.D., Chief Medical Officer, Hazelden Betty
      Ford Foundation................................................    22
        Prepared statement...........................................    25
        Answers to submitted questions...............................   107
    Laurence M. Westreich, M.D., President, American Academy of
      Addiction Psychiatry...........................................    38
        Prepared statement...........................................    40
    Anna Lembke, M.D., Assistant Professor, Psychiatry and Behavioral
      Sciences, Stanford University School of Medicine...............    45
        Prepared statement...........................................    48
        Answers to submitted questions...............................   111
    Adam Bisaga, M.D., Research Scientist, New York State Psychiatric
      Institute......................................................    54
        Prepared statement...........................................    56
    Patrice A. Harris, M.D., Secretary, Board of Trustees, American
      Medical Association............................................    68
        Prepared statement...........................................    70
        Answers to submitted questions...............................   115

                               Submitted Material

    Subcommittee memorandum..........................................    98

        COMBATING THE OPIOID ABUSE EPIDEMIC: PROFESSIONAL AND ACADEMIC
                                  PERSPECTIVES

                                  ----------

                            THURSDAY, APRIL 23, 2015

                      House of Representatives,
          Subcommittee on Oversight and Investigations,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 10:17 a.m., in
    room 2322 of the Rayburn House Office Building, Hon. Tim Murphy
    (chairman of the subcommittee) presiding.
        Members present: Representatives Murphy, McKinley, Burgess,
    Blackburn, Bucshon, Brooks, Mullin, Hudson, Collins, Cramer,
    DeGette, Schakowsky, Tonko, Clarke, Kennedy, and Green.
        Staff present: Leighton Brown, Press Assistant; Noelle
    Clemente, Press Secretary; Brittany Havens, Legislative Clerk;
    Graham Pittman, Staff Assistant; Chris Santini, Policy
    Coordinator, Oversight and Investigations; Alan Slobodin,
    Deputy Chief Counsel, Oversight; Sam Spector, Counsel,
    Oversight; Jean Woodrow, Director, Information Technology; Jeff
    Carroll, Democratic Staff Director; Ashley Jones, Democratic
    Director, Outreach and Member Services; Christopher Knauer,
    Democratic Oversight Staff Director; Una Lee, Democratic Chief
    Oversight Counsel; and Elizabeth Letter, Democratic
    Professional Staff Member.

       OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
             CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

        Mr. Murphy. All right, good morning. We are here at the
    Oversight and Investigations Subcommittee hearing on Combating
    the Opioid Abuse Epidemic: Professional and Academic
    Perspectives. Welcome.
        Less than 1 month ago, on March 26, we held the first in a
    series of hearings to examine the growing problems of
    prescription drugs and heroin abuse. During that brief span of
    time, according to the best estimates from the Department of
    Health and Human Services, at least 3,374 Americans will have
    died from drug overdoses, with opioids being the most common
    cause. That is 3,374 overdose deaths in less than 1 month.
    Indeed, during the time we spend in this hearing, another 10
    lives will be lost.
        The headlines out of Pittsburgh last week sent shockwaves
    throughout my district with 10 heroin overdoses in a single 24-
    hour period. Of the two who died, they were found with stamped
    bags marked either ``Chocolate'' or ``Chicken/Waffle.'' And
    this is what we are up against. This is what is killing our
    sons and daughters, brothers and sisters, mothers and fathers.
        Let me state clearly so as to leave no room for doubt: Our
    current strategy just isn't working, and I am not going to stop
    until we start moving in the direction of success, defined not
    just as getting individuals off of street drugs and onto a
    Government-approved opioid, but getting them to the point of
    drug-free living.
        About 3 weeks ago, on the very same day this committee held
    our first hearing on this issue, the Department of Health and
    Human Services released its long-awaited three-part plan to
    reverse this epidemic. Elements of the plan made sense;
    however, I am puzzled and amazed to read one particular
    priority included in their press release, and I quote,
    ``Exploring bipartisan policy changes to increase use of
    buprenorphine and developing the training to assist
    prescribing.''
        We are in desperate need of innovations to reverse the
    current trend and not merely maintain it. Why would we focus
    only a single opioid replacement program rather than the full
    range of FDA-approved treatments for opioid addiction? Why the
    fixation on one pharmaceutical product? According to testimony
    presented to this committee last year by the Director of
    SAMHSA's Center for Substance Abuse Treatment, nearly 1 million
    people were prescribed buprenorphine in 2011. We know that
    number is much higher today, probably closer to 1.5 million
    people or more. Think about that. Success by Federal Government
    standards for addiction disorders is 1.5 million people
    prescribed synthetic opioids. Yet, consider the sad fact that
    States have not seen their investment in prescription clinics
    reverse this opioid epidemic. States like Maryland, Vermont,
    Massachusetts and others that have made massive investments in
    buprenorphine maintenance have not seen reductions in overdose
    deaths. On the contrary, things have gotten much much worse.
        According to the DEA, buprenorphine is the third most
    confiscated drug in law enforcement activities in our country
    today. More than morphine, more than methadone, more than
    codeine. Patients are routinely getting buprenorphine
    prescribed as ``heroin helper'', meaning they get a month's
    supply of buprenorphine to use whenever they can't get heroin.
    It tides them over, enabling them to remain in their active
    addiction. This should more accurately be called addiction
    maintenance, not just the euphemistically called, opioid
    maintenance.
        Some addicted to methamphetamines go to local bupe mills
    and get a 30-day supply that they promptly sell to buy their
    drug of choice. In the field of addiction treatment, the
    enabler is part of the problem. Helping intentionally or
    unintentionally to keep a family member as an alcohol or drug
    addict is enabling. Here, the U.S. Government is the biggest
    enabler of them all.
        Some clinics operate cash-only businesses for writing 30-
    day supplies of buprenorphine at the highest permissible doses;
    usually 32 milligrams, knowing full well patients will sell at
    least of half of the pills in order to pay for their treatment
    or other illicit drugs.
        At our last hearing, Professor Sarah Melton at East
    Tennessee University noted that that there are methadone
    clinics operating on a cash basis, handing out methadone
    without any other treatment, or buprenorphine pill mills. It is
    not acceptable that Federal taxpayer money be used to support
    programs that hand out these drugs for cash. Worse, Professor
    Melton testified that there was a dearth of good treatment
    programs. And what happens after the patient leaves the
    treatment program? What is being done to follow-up with
    patients to prevent relapses and put them on a path of real
    recovery? I fully recognize the importance of medication-
    assisted treatment as a transition from street drugs and to
    prevent overdose from heroin, but relying on this as the one
    and only solution shouldn't be the strategy.
        As I recently heard Dr. McLellan, the former Deputy
    Director of ONDCP say, while there is an appropriate place for
    medication-assisted treatment, we should not turn a blind eye
    to the fact that there is also a tremendous amount of
    medication-assisted addiction. It is not acceptable for Federal
    taxpayer money to be used to support treatment programs that
    lack evidence of effectiveness, or that define success merely
    as an individual with an addiction disorder using heroin fewer
    times per week than before treatment.
        I am calling for a patient-centered initiative with a goal
    of matching patients with the most appropriate care, coupled
    with a focus on transition not just off street drugs, but
    eventual transition from opioids altogether. I hope to
    modernize our existing opioid addiction treatment system to
    ensure that the right patient gets the right treatment at the
    right time. It simply isn't true to present buprenorphine and
    methadone as opioid-free treatment. We do a tremendous
    disservice to those living with addiction disorders when we
    advance disingenuous double-talk and not state outright that
    buprenorphine and methadone are highly potent opioids.
        We are not going to end this opioid epidemic by increasing
    the use of opioids. We need an exit strategy that enables
    Americans to become opioid-free altogether. We can do better
    than addiction maintenance. We can and we must.
        I look forward to working with my colleagues and HHS as we
    explore new innovations for detoxification and treatment models
    to transition individuals off of all opioids and into evidence-
    based counseling with non-addictive, non-narcotic behavioral
    and medication treatments. We don't do enough to help those
    addiction disorders. I believe in recovery. I believe in lives
    being restored so that every individual may live to their full
    God-given potential and do so drug free. I consider opioid
    maintenance as a bridge to cross over in addiction recovery,
    not a final destination. At this point, the Government simply
    stopped building the bridge. We have not yet fully helped move
    those with addiction disorders beyond opioid maintenance, and I
    seek to lay out a vision for recovery that includes complete
    withdrawal from opioids as an option. Once we lay out those
    goals, we can then move forward with research and clinical
    efforts, and boldly declare that we are no longer satisfied
    with the status quo of opioid maintenance only.
        To assist us today, the subcommittee will hear from some of
    the Nation's foremost professional and academic experts in the
    field of opioid addiction. Among these questions we hope these
    experts will address are, What can be done to incentivize
    individual compliance with prescribed treatment plans and
    reduce the risk of relapse? What should be the aim of treatment
    for opioid addiction: reduce the intake of illicit drugs by
    these individuals to more moderate levels, or should the aim be
    to place patients on a path to detoxification and ultimately a
    full recovery, ending all illicit uses and removing the need
    for lifelong opioid maintenance recovery? To what extent is the
    increased prescribing of methadone for pain contributing to
    more overdose deaths? Are Medicaid and Medicare payments for
    the treatment of pain incentivizing doctors to prescribe the
    opioids like candy for the treatment of pain?
        Today we have assembled some of the leading opioid
    addiction experts. We welcome you to get your thoughts on
    dealing with this epidemic. And I thank you for your expertise
    and look forward to hearing your testimony.
        [The prepared statement of Mr. Murphy follows:]

                     Prepared statement of Hon. Tim Murphy

        Less than one month ago, on March 26, we held the first in
    a series of hearings to ``Examine the Growing Problems of
    Prescription Drug and Heroin Abuse.'' During that brief span of
    time, according to the best estimates from the Department of
    Health and Human Services, at least 3,374 Americans will have
    died from drug overdoses, with opioids being the most common
    cause. That's 3,374 overdose deaths in less than one month.
    Indeed, during the time we spend in this hearing, another 10
    lives will be lost.
        The headlines out of Pittsburgh last week sent shock waves
    throughout my district: 10 heroin overdoses in a single 24-hour
    period. On the 2 who died were found stamped bags marked either
    ``Chocolate'' or ``Chicken/Waffle.'' This is what we are up
    against. This is what is killing our sons and daughters;
    brothers and sisters, fathers and mothers.
        Let me state clearly so as to leave no room for doubt: Our
    current strategies are failing and I am not going to stop until
    we start moving in the direction of success defined not just as
    getting individuals off of street drugs and onto a Government-
    approved opioid, but getting them to the point of drug free
    living.
        About three weeks ago, on the very same day this committee
    held our first hearing on this issue, the Department of Health
    and Human Services released its long-awaited three-part plan to
    reverse this epidemic. Elements of the plan make sense;
    however, I am puzzled and amazed to read one particular
    priority included in their press release (and I quote):
         Exploring bipartisan policy changes to increase
    use of buprenorphine and develop the training to assist
    prescribing.
        We are in desperate need of innovations to reverse the
    current trend and not merely maintain it. Why would we focus
    only a single opioid replacement program rather than the full
    range of FDA-approved treatments for opioid addiction? Why the
    fixation on one pharmaceutical product?
        According to testimony presented to this committee last
    year by the Director of SAMHSA's Center for Substance Abuse
    Treatment, nearly one million people were prescribed
    buprenorphine in 2011. We know that number is much higher
    today, probably closer to 1.5 million people or more.
        Think about that. Success by Federal Government standards
    for addiction disorders is 1.5 million people prescribed
    synthetic opioids. Yet, consider the sad fact that States have
    not seen their investment in prescription clinics reverse the
    opioid epidemic. States like Maryland, Vermont, Massachusetts
    and others that have made massive investments in buprenorphine
    maintenance have not seen reductions in overdose deaths. On the
    contrary, things have only gotten much much worse:
         According to the DEA, buprenorphine is the third
    most confiscated drug in law enforcement activities in our
    country today. More than morphine, more than methadone, more
    than codeine.
         ``Patients'' are routinely getting buprenorphine
    prescribed as ``heroin helper''--meaning they get a month's
    supply of buprenorphine to use whenever they can't get heroin.
    It tides them over,enabling them to remain in their active
    addiction. This should more accurately be called `` addiction
    maintenance'' not just the euphemistic, ``opioid maintenance.''
         Some addicted to methamphetamines go to local
    ``bupe mills'' and get a 30-day supply that they promptly sell
    to buy their drug of choice.
         In the field of addiction treatment, the
    ``enabler'' is part of the problem--helping intentionally or
    unintentionally to keep a family member as an alcoholic or drug
    addict. Here, the U.S. Government is the biggest enabler of
    them all.
         Some clinics operate cash-only businesses for
    writing 30-day supplies of buprenorphine at the highest
    permissible doses (usually 32 milligrams) knowing full well
    patients will sell at least of half of the pills in order to
    pay for their ``treatment'' or other illicit drugs.
        At our last hearing, Professor Sarah Melton at East
    Tennessee University noted that that there are methadone
    clinics operating on a cash basis handing out methadone without
    any other treatment, or buprenorphine ``pill mills.'' It is not
    acceptable that Federal taxpayer money be used to support
    programs that hand out these drugs for cash. Worse, Professor
    Melton testified that there was a dearth of good treatment
    programs. And what happens after the patient leaves the
    treatment program? What is being done to follow-up with
    patients to prevent relapses and put them on a path of real
    recovery?
        I fully recognize the importance of medication assisted
    treatment as a transition from street drugs and to prevent
    overdose from heroin. But relying on this as the one and only
    solution shouldn't be the strategy. As I recently heard Dr.
    McLellan, the former Deputy Director of ONDCP say, while there
    is an appropriate place for ``medication assisted treatment''
    we should not turn a blind eye to the fact that there is also a
    tremendous amount of ``medication assisted addiction.'' It is
    not acceptable for Federal taxpayer money to be used to support
    treatment programs that lack evidence of effectiveness, or that
    define ``success'' merely as an individual with an addiction
    disorder using heroin fewer times per week than before
    treatment.
        I am calling for a patient-centered initiative with a goal
    of matching patients with the most appropriate care coupled
    with a focus on transition not just off of street drugs but
    eventual transition from opioids altogether. I hope to
    modernize our existing opioid addiction treatment system to
    ensure that the right patient gets the right treatment at the
    right time. It simply isn't true to present buprenorphine and
    methadone as opioid-free treatment. We do a tremendous
    disservice to those living with addiction disorders when we
    advance disingenuous double-talk and not state outright that
    buprenorphine and methadone are highly potent opioids.
        We are not going to end this opioid epidemic by increasing
    the use of opioids. We need an exit strategy that enables
    Americans to become opioid-free altogether. We can do better
    than addiction maintenance. We can and we must. I look forward
    to working with my colleagues and HHS as we explore new
    innovations for detoxification and treatment models to
    transition individuals off of all opioids into evidencebased
    counseling with non-addictive, non-narcotic behavioral and
    medication treatments.
        We don't do enough to help those addiction disorders. I
    believe in recovery. I believe in lives being restored so that
    every individual may live to their full God-given potential and
    do so drug free. I consider opioid maintenance as a bridge to
    cross over in addiction recovery, not a final destination. At
    this point, we've simply stopped building the bridge. We've not
    yet fully helped move those with addiction disorders beyond
    opioid maintenance. I seek to lay out a vision for recovery
    that includes complete withdrawal from opioids as an option.
    Once we lay out those goals, we can then move forward with
    research and clinical efforts, and boldly declare that we are
    no longer satisfied with the status quo of opioid maintenance
    only.
        To assist us today, the subcommittee will hear from some of
    the Nation's foremost professional and academic experts in the
    field of opioid addiction. Among the questions we hope these
    experts will address are: What can be done to incentivize
    individual compliance with prescribed treatment plans and
    reduce the risk of relapse? What should be the aim of treatment
    for opioid addiction: reduce the intake of illicit drugs by
    these individuals to more moderate levels? Or should the aim be
    to place patients on a path to detoxification and ultimately a
    full recovery, ending all illicit uses and removing the need
    for lifelong opioid maintenance recovery? To what extent is the
    increased prescribing of methadone for pain contributing to
    more overdose deaths? Are Medicaid and Medicare payments for
    the treatment of pain incentivizing doctors to prescribe
    opioids like candy for the treatment of pain?
        Today we have assembled some of the leading opioid
    addiction experts to get your thoughts about how to reverse
    this epidemic. We thank you for your expertise and look forward
    to hearing your testimony.

        Mr. Murphy. I now recognize Ms. DeGette for 5 minutes.

     OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF COLORADO

        Ms. DeGette. Thank you so much, Mr. Chairman. Before I make
    my opening statement, I want to announce today is Take Your
    Daughter to Work Day. My daughters tragically have grown up,
    but I have my daughter-for-the-day today, Paula, who is with
    us. Paula is a sixth-grader at Howard Middle School, and she is
    going to be with me today. She just told me she thought it
    would be really boring to come to the Capitol, but actually, so
    far she has found it to be fascinating. So I think she has a
    career ahead of her in politics, and we are glad to have her.
        I am also glad, Mr. Chairman, that we are having this
    hearing today. This is our second hearing in the series on this
    very important issue.
        This is a problem that touches all parts of the country and
    is growing. In 2013, 50 percent of all drug overdoses in this
    country were related to prescription pharmaceuticals. In
    Colorado, my home State, the rate of prescription overdose
    deaths has quadrupled in the last 10 years.
        I am happy to have this distinguished panel today who I
    hope can actually talk about, Mr. Chairman, what you suggest
    which is science-based treatments, and the best practices for
    treating this disease. All of our panelists have years of
    experience treating patients struggling with addiction, and I
    want to hear what all of you think is the most effective
    treatment.
        In our last hearings, we received considerable testimony
    from experts who told us that medication-assisted treatment, or
    MAT, can play a vital role in treating opioid addiction.
    Experts tell us that a combination of MAT and behavioral
    treatment, such as counseling and other supportive services, is
    the best way of treating opioid addiction. And, of course,
    there are several FDA-approved medications that have proven
    effective in treating opioid addiction.
        Now, Mr. Chairman, in your opening, you talked about
    science-based treatments, and I completely support that. You
    also talked about patient-oriented treatments, and I support
    that too. But in doing that, we need to recognize that while it
    is the goal to get everybody off of these drugs if possible, it
    is not always the case, and we need to look and see at the
    treatments that should be available for every patient. And so
    in an ideal world, we would have all the options available to
    every patient, and we should strive for that, but right now,
    MAT is not an available option for all patients. Dr. Bisaga,
    for example, will testify today that very few patients with
    opioid addiction receive treatments that have been proven the
    most effective, which includes access to MAT. What many
    Americans receive instead is a form of rapid detoxification
    from the drug, followed by an abstinence-only approach. Dr.
    Bisaga and others have called this method outdated and mostly
    ineffective, and even worse, I suppose, it could be dangerous
    because patients face a significantly elevated risk of dying by
    overdose if they relapse. So I want to ask questions about that
    today. Is it true that most Americans with opioid addictions
    don't receive the most effective treatments? Do they and their
    loved ones understand that? Is it true that many patients
    receive treatments that some experts suggest may be ineffective
    or dangerous? And finally, why is not MAT available as an
    alternative to all patients seeking treatment?
        From the perspective of the Federal Government, it is
    important to have science-based policy so that we are expending
    our resources on efforts that actually have a chance at
    success. And patients seeking treatment for opioid addiction
    should be apprised of the benefits and risks of alternative
    treatment approaches.
        Now, I understand that we need more study to predict which
    treatment alternatives will be effective for any given patient,
    and that is why I look forward to hearing from Dr. Seppala
    about the work he is doing at the Hazelden Betty Ford to
    collect data on factors. And by that way, in that vein, I want
    to recognize our former colleague, Mary Bono, who is here with
    us today, and a former member of this wonderful committee. So
    we are glad to have you here, Mary.
        I also recognize that we need more study regarding how to
    best treat opioid-addicted patients for the long-term,
    particularly people who want to taper off of the medications.
    And I certainly understand and support the desire to move
    toward medication-free recovery, but we also need to make sure
    that patients understand the risk.
        Finally, Mr. Chairman, much of what is being done to
    prevent and treat the opioid epidemic is happening on the State
    level. I am hoping in one of our future hearings that we can
    have witnesses come from the States to talk about their
    approaches. In Colorado, for example, we have the Colorado
    Consortium for Prescription Drug Abuse Prevention, which is a
    statewide coalition, and which is designing targeted programs.
    So when we have our hearing, I would like to have someone from
    Colorado.
        I think that this hearing will give us more information,
    and information and science-based decision making is really
    what we need to make effective use of our resources to
    combating this very, very serious problem of opioid abuse.
        And I yield back. Thank you.
        Mr. Murphy. Thank you.
        I now recognize the vice chairman of the full committee,
    Mrs. Blackburn, for 5 minutes.

    OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF TENNESSEE

        Mrs. Blackburn. Thank you, Mr. Chairman. And it is indeed
    Take Your Daughter to Work Day. And after I get to Nashville
    this afternoon, my daughter will go to an event with me. But
    she is an adult and, of course, has two children of her own,
    and we will not take them to that event.
        It is so good to see our former colleague, Mary Bono, here
    and I appreciate the good work that she continues to do on this
    issue.
        And, Mr. Chairman, I thank you for the hearing because this
    is a critical public health issue, and it does need our
    attention and our best efforts. And we are going to continue to
    look at this problem of prescription drug and heroin abuse
    because it has skyrocketed. And since '97, the number of
    Americans seeking treatment for addiction to painkillers has
    increased by 900 percent. That should give us all pause. Deaths
    related to heroin abuse increased 39 percent from 2012 to '13.
    That is a 2-year period of time. And while heroin use in the
    general population is still low, the number of people beginning
    to use it has steadily increased since 2007. And according to
    the National Institute on Drug Abuse, part of the explanation
    for the trend is a shift from the abuse of prescription pain
    relievers to heroin as a more potent, readily available and
    cheaper alternative to prescription opioids.
        Addiction and deaths due to overdose are just the tip of
    the iceberg in terms of medical consequences of this problem.
    One tragic consequence of the problem is neonatal abstinence
    syndrome. According to Dr. Stephen Patrick at Vanderbilt, in
    2013, Tennessee became the first State to make NAS a publicly
    reportable condition to the Department of Health. From
    information reported to our Tennessee Department of Health, we
    know the overall rate is 13 cases out of 1,000 births in the
    State of Tennessee. We can and we must do better for these
    babies. Our goal is to improve the Federal Government response
    to this crisis.
        Recently we heard from witnesses who expressed the State
    and local perspectives on this issue. Last year, we heard from
    a Federal panel of witnesses, including CDC, DEA, SAMHSA, NIH,
    and the Office of National Drug Control Policy, and today, we
    are rounding out this focus by hearing from you all who will
    give us the professional and academic perspectives. And we look
    forward to your testimony today, and we welcome you.
        And I yield back.
        Mr. Murphy. And nobody else on this side seeking final 2
    minutes, then I will turn towards Ms. Schakowsky for 5 minutes.

           OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A
         REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS

        Ms. Schakowsky. Thank you, Chairman Murphy and Ranking
    Member DeGette, for calling this very important hearing on
    prescription drug and heroin abuse in the United States. Also
    thanks to our witnesses for coming here today to shed more
    light on this issue.
        This hearing could not be timelier. Increasingly, we are
    hearing reports of the toll this crisis is taking in
    communities across the country. And like myself, I am sure that
    every member of the subcommittee has heard stories from their
    constituents about the toll of prescription drug abuse and
    heroin abuse, the toll that it has taken in their districts.
        I have mentioned previously before this committee that I
    have a constituent, Peter Jackson, who tragically lost his 18-
    year-old daughter, Emily, after she consumed a single Oxycontin
    tablet that she received from her cousin while visiting family.
    I look forward to hearing from our witnesses about the most
    effective ways to combat prescription drug abuse, to learn what
    additional steps we can take together to stop this crisis, and
    to prevent the further tragic loss of life.
        I also want to call attention to the impact that reducing
    discretionary spending will have on access to treatment and
    research on addiction. Just yesterday, House republicans
    approved budget allocations that will further cut discretionary
    spending for vital programs like SAMHSA and the National
    Institutes of Health. We have already heard--and we have
    already seen devastating cuts to these same programs. For
    example, the Substance Abuse Prevention and Treatment Block
    Grant within SAMHSA when adjusted for inflation has actually
    been cut by 25 percent in the last 10 years.
        While we are here today to discuss the most effective
    methods of treating addiction, without Federal funding for
    programs, patients will simply not have access to these
    services, and research on addiction and treatment of addiction
    will greatly suffer. That is just a fact. If we are serious
    about combating the opioid epidemic, it is incumbent that we
    provide strong Federal funding for the programs that patients
    and researchers rely on.
        And I want to yield the balance of my time to
    Representative Tonko.

       OPENING STATEMENT OF HON. PAUL TONKO, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF NEW YORK

        Mr. Tonko. I thank the gentlewoman from Illinois for
    yielding.
        Each and every year, I have spent Super Bowl Sunday in a
    soup kitchen, working alongside and serving individuals of the
    addiction recovery community. Why? Because I choose to land
    myself in the midst of real heroes. The individuals of the
    addiction recovery community, in my mind, through their
    courage, determination, and conviction are truly heroes.
    Bearing witness to the joy and rebirth that recovery has
    brought to their lives leaves me no doubt that complete
    recovery to a substance-free life is, and should be, our goal
    for every person who is struggling in the throes of addiction;
    a disease.
        While recovery remains the goal, it is nearly impossible to
    achieve without access to effective treatments. Science tells
    us that the most effective treatment available for opioid
    addiction is a combination of medication-assisted treatments,
    commonly known as MATs, and behavioral therapy. MATs might not
    be the preferred treatment for everyone, but they constitute a
    vital tool in our toolbox for treating opiate addiction.
    Unfortunately, MATs were available in only 9 percent of all
    substance use facilities nationwide in 2013, according to
    SAMHSA. While I will acknowledge the concerns that a reliance
    on MATs can raise, the immediate tragedy here isn't that some
    individuals won't be able to taper off maintenance medications,
    it is that most won't even be able to access an evidence-based
    treatment modality that has proven to be their best chance of
    easing the burdens of addiction and saving lives. Across my
    district, there are hundreds on waitlists to access this
    treatment. Every minute we delay, needed treatment costs lives.
    In just the time that we are having this hearing today, 5 more
    people will die from am opioid overdose, and 4 out of 5
    addicted to opioids will have no access whatsoever to
    treatment. This is totally unacceptable.
        No treatment option is perfect, and I strongly support
    further research that will help us create more effective
    treatments and cures that can rid us of addiction once and for
    all. For now though, our focus has got to be on curbing the
    epidemic, expanding treatment, savings lives, and giving people
    the stability they truly need to achieve recovery.
        I look forward to hearing the perspective of our witnesses
    on these pressing issues. And I yield back, Mr. Chair, the
    balance of my time.
        Mr. Murphy. Thank you. The gentleman yields back.
        And so we will go right into our witnesses and try and get
    all your testimony done before we have votes, and we will come
    back after votes too.
        We have with us today Dr. Robert DuPont, the President of
    the Institute for Behavior and Health. Additionally, Dr. DuPont
    was the first director of the National Institute on Drug Abuse.
    Welcome. Dr. Marvin Seppala, the Chief Medical Officer at
    Hazelden Betty Ford Foundation. As acknowledged, Ms. Bono is
    here with you today. Dr. Westreich is the President of the
    American Academy of Addiction Psychiatry. Dr. Anna Lembke is an
    Assistant Professor of Psychiatry and Behavioral Science at
    Stanford University Medical Center. And Dr. Adam Bisaga is an
    Associate professor of Clinical Psychiatry in the Department of
    Psychiatry at the College of Physicians and Surgeons of
    Columbia University, and and a research scientist at the New
    York State Psychiatric Institute. Finally, Dr. Patrice Harris,
    Elected Member of the American Medical Association, Board of
    Trustees. Dr. Harris has served on the Board of the American
    Psychiatric Association, and was an APA delegate to the AMA. I
    feel like I should get continuing education credits today----
        Ms. DeGette. I know.
        Mr. Murphy [continuing]. For being here.
        I will now swear in the witnesses.
        You are aware that the committee is holding an investigate
    hearing, and when doing so, has the practice of taking
    testimony under oath. Do you have any objections to taking
    testimony under oath? All the witnesses say they do not object.
    So the Chair then advises you that under the rules of the House
    and the rules of the committee, you are entitled to be advised
    by counsel. Do any of you desire to be advised by counsel
    during testimony today? All the witnesses decline. So in that
    case, will you all please rise, raise your right hand, and I
    will swear you in.
        [Witnesses sworn.]
        Mr. Murphy. Thank you. All the witnesses have answered in
    the affirmative. So you are now under oath and subject to the
    penalties set forth in Title XVIII, Section 1001 of the United
    States Code. I will call upon you each to give a 5-minute
    statement. Just pull the microphone close to you, press the
    button, and make sure the light is on. And try and keep your
    comments under 5 minutes.
        Dr. DuPont, you are recognized first.

    STATEMENTS OF ROBERT L. DUPONT, M.D., PRESIDENT, INSTITUTE FOR
       BEHAVIOR AND HEALTH, INC.; MARVIN D. SEPPALA, M.D., CHIEF
     MEDICAL OFFICER, HAZELDEN BETTY FORD FOUNDATION; LAURENCE M.
       WESTREICH, M.D., PRESIDENT, AMERICAN ACADEMY OF ADDICTION
    PSYCHIATRY; ANNA LEMBKE, M.D., ASSISTANT PROFESSOR, PSYCHIATRY
        AND BEHAVIORAL SCIENCES, STANFORD UNIVERSITY SCHOOL OF
    MEDICINE; ADAM BISAGA, M.D., RESEARCH SCIENTIST, NEW YORK STATE
    PSYCHIATRIC INSTITUTE; AND PATRICE A. HARRIS, M.D., SECRETARY,
            BOARD OF TRUSTEES, AMERICAN MEDICAL ASSOCIATION

                     STATEMENT OF ROBERT L. DUPONT

        Dr. DuPont. Thank you, Mr. Chair. It is a privilege for me
    to be with you.
        And let me pick up on some of the things that were
    presented just now. I think one of the most counterproductive
    approaches to the problem is to pick drug-free against
    medication-assisted treatment, and I think every time we do
    that we undermine dealing with the problem at all. We undermine
    public confidence, and I think it is contrary to what the
    public interest is and public health. And let me be very clear
    that I believe that full recovery is consistent with continuing
    to take medications for opiate dependence; buprenorphine,
    methadone, and naltrexone. The issue to recovery, to me, is not
    whether they are taking the medicine, it is are they using
    drugs, are they using alcohol, are they still involved in drug-
    dependent behavior. And that is not compatible with recovery.
    And I am going to talk a little bit more about that issue about
    drug use in medication-assisted treatment, which I don't think
    is recovery, but I think that concept is very important, just
    like these patients taking psychiatric medicines is fully
    compatible with recovery. So I think that, to me, is a way to
    bring this together.
        And I also point out what Dr. Marv Seppala is going to talk
    about on the Hazelden Program, which brings together medication
    and the drug-free programs as the way into the future.
        And the last point I want to make before I really get
    started is to think about the elephant in the room when we are
    talking about recovery, and that is the 12-step programs; AA
    and NA, are an enormous part of what we are talking about,
    about getting well. We did a study, the first national study of
    physicians health programs, and we have now followed up with
    that 5 years after the mandatory monitoring. And 97 percent of
    those physicians were still in recovery 5 years after
    mandatory--and we asked them what part of the program was most
    helpful to you, and they were in very high quality treatment
    and many other services, by far the biggest percentage was
    participation in 12-step programs. That was what was most
    important to them. So I want to make sure at our hearing we
    understand the importance of that in terms of recovery.
        Now, my focus is on the users, and I want to make one point
    very clear. Opiate dependence is not like the common cold; it
    does not go away, it is a lifetime problem. A person who has
    opiate dependence is going to deal with that problem one way or
    another for his or her lifetime. If you don't understand that
    then the concept of treatment is confusing because you think
    you are going to be confusing because you think you are going
    to be fixed in treatment. People are not fixed in treatment
    with opiate dependence. Treatment can help them find their path
    to recovery, but treatment is not recovery, and it is really
    important that people are not fixed in any treatment, drug-free
    or medication treatment. It is a lifetime struggle, and that is
    a very important perspective on this.
        Now, my concern is that treatment does not match up with
    the disease. The treatment is always short-term. Even
    medication-assisted treatment, which conceptually goes on for a
    lifetime, has very high drop-out rates, very rapid--patients
    drop out of the program for medication-assisted treatment. And
    the other thing is a high percentage of people in medication-
    assisted treatment continue to use opiates and other drugs
    while they are in the program. That is very important to notice
    that and pay attention to that. But even more important, and
    the thrust of my testimony, all of it is accountability for
    treatment. What are the results during treatment? What
    percentage of the patients are continuing to use drugs? How
    much retention is there? What is the retention curve of the
    program? How long do they stay in treatment? And when they
    leave, are they any better off than they were when they came
    in? Those questions need to be asked and answered in a
    systematic way.
        The other thing I pick up on the chairman's statement about
    the standard. What we want is recovery. That means no use of
    alcohol and other drugs, including opiates, not just opiates
    but all drugs. That is what recovery is. It requires that. And
    what I am proposing and encouraging the committee to do is to
    look long-term, because the nature of the disorder is long-
    term. And I use the 5-year recovery standard. Start with a
    person who enters treatment. Where is that person in 5 years?
    And you can look at any program; drug-free or maintenance--or
    medication-assisted, and ask the question how good is this
    program at getting a person into a stable recovery. That is one
    standard for all treatments, and it gets you focused on the
    long-term. And when we do that in this country, including in
    the Federal Government, the whole game changes and we have a
    mechanism to improve treatment. Treatments can all compete on a
    level playing field to achieve that goal.
        So that is my testimony. Thank you very much.
        [The prepared statement of Dr. DuPont follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you. Thank you very much.
        Dr. Seppala, you are recognized for 5 minutes.

                     STATEMENT OF MARVIN D. SEPPALA

        Dr. Seppala. Chairman Murphy and Ranking Member DeGette,
    thank you very much for inviting me to participate in this
    important hearing, and for your leadership in addressing the
    crisis of addiction to opioids in this country.
        My name is Marv Seppala, I am the Chief Medical Officer of
    the Hazelden Betty Ford Foundation. I attended Mayo Medical
    School, and have been practicing in the addiction field for 27
    years. On a personal note, I have also been in long-term
    recovery from addiction since age 19.
        The Hazelden Betty Ford Foundation is the Nation's largest
    nonprofit addiction treatment provider, and we have been around
    since 1949. We have 16 sites in 9 States. We offer prevention
    and recovery solutions nationwide for youth and adults. At our
    facilities, we have seen a pronounced increase in the number of
    patients with opioid use disorders, paralleling the grim
    stories you have probably been hearing about in your districts
    for some time now. At our residential youth facility, for
    example, opioid dependence rates increased from 15 percent of
    patients in 2011 to 42 percent in 2014. That is a dramatic
    rise, and this is an especially difficult addiction to treat.
    Individuals dependent on prescription pain medications and
    heroin often face unique challenges that can undermine their
    ability to stay in treatment and ultimately achieve long-term
    recovery. They are hypersensitive to pain and more vulnerable
    to stress. Their anxiety, depression, and intense craving for
    these drugs can continue for months, even years, after getting
    free from opioid use. They experience a strong desire to feel
    normal again, to escape what seems like a permanent state of
    dysphoria, which puts them at high risk for relapse. They are
    also at higher risk of accidental overdose during relapse
    because they no longer have the tolerance to handle the same
    doses they were taking prior to treatment. In other words, with
    opioids, unlike other drugs, relapse often means death.
        In 2012, we launched a new protocol to treat opioid
    addiction, the Comprehensive Opioid Response with 12 Steps, or
    COR-12 as we call it. Our approach is grounded in the
    traditional 12-step facilitation model and based on abstinence,
    but it now also utilizes the safest live-saving medications
    that keep patients engaged in recovery long enough to achieve
    lasting sobriety.
        We don't see a conflict in utilizing medications and
    pursuing abstinence, just as Bob described. Even when
    medications are part of our protocol, abstinence is still the
    objective. In fact, one might call it a third way because it
    strikes a reasonable commonsense balance between those who see
    medication assistance and abstinence as diametrically opposed.
        Our COR-12 Program includes changes to traditional group
    therapy, additional patient education about opioids, and the
    option now of medication assistance. We utilize extended-
    release naltrexone, Vivitrol, as well as buprenorphine/
    naloxone, or Suboxone, to help engage patients long enough to
    complete treatment, and then become established in solid 12-
    step recovery. The highest risk period for relapse is the first
    12 to 18 months after treatment, so we prefer to have our
    patients involved and on medication in outpatient care
    throughout this extended period. And our goal is to discontinue
    medication as our patients become established in long-term
    recovery.
        While our clinicians recommend which medication is
    appropriate, the final decision is up to the patient, and about
    \1/3\ of our COR-12 patients elect to use no medication.
    Indeed, medication only addresses the biologic aspect of
    addiction. Our broader measures treat the psychological,
    social, and spiritual components to improve psychosocial
    functioning, enrich relationships, and foster a healthier
    lifestyle. And those are the keys to recovery that last.
        Our COR-12 Program has resulted in more patients completing
    residential treatment, and a reduction in overdose deaths after
    treatment. While the research study of COR-12 is ongoing, and
    we do not have full results yet, we do know that COR-12
    patients stay in treatment longer. Our atypical discharge rate,
    those who leave treatment early, for our general population is
    13 \1/2\ percent, and for those with opioid dependence who
    don't enter this program, it is over 22 percent. However, in
    this program, it is only 7.5 percent.
        Now, based on our early positive results, we plan to
    continue paving the way for others to use both scientific and
    spiritual solutions to engage more people in treatment, save
    lives, and ultimately help more people get into long-term
    recovery.
        I would also like to emphasize the need to educate a wider
    culture about the dangers of opioid overprescribing. The
    troubling trends began to emerge in the late '90's after the
    FDA approved Oxycontin and allowed it to be promoted to primary
    care physicians for treatment of common aches and pains.
    Education campaigns often funded by opioid manufacturers
    minimized risks, especially the risk of addiction, and
    exaggerated benefits to using these opioids long-term for
    common problems. When prescribing on a short-term basis to
    treat moderate to severe acute pain, opioids can be helpful,
    but when these are highly addictive medications that are taken
    around the clock for weeks, months, and years, they may
    actually produce more harm than healing. An increasing body of
    research suggests that for many chronic pain patients, opioids
    are neither safe nor effective. Over time, patients often
    develop tolerance, leading them to require higher and higher
    doses, which ultimately can lead to quality of life issues and
    functional decline.
        It should be noted that doctors didn't start
    overprescribing out of malicious intent, but rather out of a
    desire to relieve pain more compassionately.
        Now, we have a culture that seeks opioid medication for
    pain relief, not just for physical pain but also to numb
    psychic pain. Some of these patients have a significant risk
    for the development of addiction in a culture that promotes
    quick fixes, instant gratification, and escapism. Medical
    professionals need further education about the proper use of
    opioid medications and their risks. The general public also
    needs such education to prove recognition of risk, and
    limitations of these powerful, dangerous medications. It is
    time now to address opioid overprescribing and overuse without
    stigmatizing pain. This crisis deserves the attention you are
    providing today, and requires a substantial response.
        Thanks again for having me here, and for your leadership. I
    look forward to answering your questions.
        [The prepared statement of Dr. Seppala follows:]

     [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you, Doctor.
        Now, Dr. Westreich, you are recognized for 5 minutes.

                   STATEMENT OF LAURENCE M. WESTREICH

        Dr. Westreich. Mr. Chairman, members of the committee,
    thank you very much for inviting me to speak to you today about
    treatment for opioid addiction. Dr. Murphy, before I start, I
    would like to say that as a psychiatrist specializing in
    addiction, I am particularly appreciative of the clinical
    awareness you have imparted to the Helping Families in Crisis
    Act, which will focus resources on helping our patients. I am
    Board certified in general psychiatry, addiction psychiatry,
    and forensic psychiatry, and I serve as president of the
    American Academy of Addiction Psychiatry, which is a
    professional organization for psychiatrists who specialize in
    the treatment of addiction and other mental illnesses.
        My primary professional focus is on the clinical treatment
    of addicted people. I trained at Bellevue, where I worked for
    many years and continue to teach, and I treat people addicted
    to opioids in my offices in Manhattan and in New Jersey, where
    I live. I know this committee understands very well the lethal
    nature of opioid addiction. You don't need us to tell you about
    that. My main goal in speaking with you today is to underline
    what you have already heard; opioid-addicted people need access
    to a broad range of treatments for opioid addiction. This must
    include access to medication-assisted therapy, and treatment
    for co-occurring psychiatric disorders. I have treated
    homeless, heroin-injecting senior citizens, college students
    who snort Oxycontin, and practicing attorneys who must take an
    opioid pill every few hours in order to continue seeing their
    clients. The death and destruction I have seen due to opioid
    addiction is profoundly disturbing, but thankfully with
    appropriate treatment, the more common return to health, the
    workplace, and family, is what keeps most of us doing the
    clinical work which helps addicted people in their search for
    recovery.
        Part of that clinical work includes full treatment for what
    is ailing the addicted person. Research demonstrates that the
    opioid-using person often has a co-occurring mental illness,
    like major depression, bipolar disorder, or PTSD. Sometimes the
    opioid user is self-medicating uncomfortable mood states or
    anxiety, or just has difficulty soothing him or herself. All
    these circumstances can increase the risk for relapse, and
    require sophisticated and individualized psychiatric evaluation
    and treatment. Research makes it clear that prescribing the
    appropriate effective medication to help the patient with
    craving, along with talk therapy and treatment for a co-
    occurring psychiatric disorder, gives the addicted person the
    best possible chance for recovery.
        That sophisticated treatment system must include access to
    well-trained clinicians who can select between the available
    psychosocial treatments like relapse prevention therapy,
    cognitive behavioral therapy, medications like buprenorphine,
    methadone, and naltrexone, and mutual support groups like
    Narcotics Anonymous. For many, mutual support groups like AA or
    NA can be extremely helpful, but they are not treatment, nor do
    they claim to be. They are support groups which can be
    lifesaving for some, and not so much for others. As you have
    heard, the available research has not provided us with a silver
    bullet that works for all opioid addiction. Rather, the data
    tell us that some treatment works for some opioid addicts some
    of the time. Others may respond to a very different approach.
    That is one reason we clinicians must have all available arrows
    in our quivers. We must have the skills and training for a
    broad array of approaches to meet the treatment needs of each
    patient. Quite often, using a treatment--team approach that
    includes psychologists, social workers, nurses and counselors,
    is critical to therapeutic success.
        The wide variety of personal choices addicted people make
    about treatment is yet another reason for supporting the full
    spectrum of treatment possibilities from medication-assisted
    treatments with buprenorphine and methadone, to opioid blockers
    like naltrexone, to relapse prevention therapy. Some patients
    demand to be treated without medications, while others clearly
    want and need medication to control their craving. And they
    also require more specific psychiatric treatment for any co-
    occurring disorders.
        Use of buprenorphine and methadone, which are both opioids
    like heroin, can be controversial. When I talk to opioid-
    addicted people and their families, I sometimes, but not
    always, recommend tapering or maintenance with buprenorphine or
    methadone. The question is not whether the medication has side
    effects; all medications do, but whether the risk is worth the
    benefit. Patients and their families need to know that
    detoxification treatment and drug-free counseling are
    associated with a very high risk of relapse. As with other
    medical conditions, the relevant question about whether a
    medication is worth the risk is the following. Compared to
    what? Is taking buprenorphine or methadone better than dying
    from an overdose, better than contracting HIV or Hepatitis,
    flunking out of school, losing a marriage, losing a job? One-
    size treatment does not fit all, and different patients may
    need different treatments. But the very good news in this
    situation is that people who are able to stop their use of
    illicit drugs, whether through psychotherapeutic interventions,
    medications, and/or help from NA, or most likely some
    combination of the above, can return to vibrant and productive
    lives. It is that return to physical and emotional health,
    which I find so gratifying; it empowers me to help my patients
    to keep trying.
        Before I stop, let me reiterate my main point, and what I
    know you have heard from many others. Opioid-addicted people
    need access to a broad range of treatments for addiction. This
    must include medication-assisted treatment, and treatment for
    co-occurring psychiatric disorders.
        Thank you very much for inviting me today.
        [The prepared statement of Dr. Westreich follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you very much.
        Dr. Lembke, you are recognized for 5 minutes.

                        STATEMENT OF ANNA LEMBKE

        Dr. Lembke. Thank you for inviting me today to these
    hearings.
        The main point I would like to make today is simple. We
    don't just have an opioid abuse epidemic or an opioid overdose
    epidemic, we have an opioid overprescribing epidemic.
        Doctors are a major pipeline of misused and diverted
    prescription opioids, and contrary to what is commonly
    believed, doctors who treat addiction are not the main source
    of the problem.
        The methadone that accounts for 40 percent of single drug
    opioid pain reliever death is almost entirely in the form of
    pills prescribed for the treatment of pain, rather than coming
    from methadone maintenance clinics that treat heroin-dependent
    patients. We, thus, need to think broadly about the problem
    with changing the behavior of all physicians and not just those
    who treat addicted patients.
        I was pleased to see the education of providers was
    identified as one of three priority areas in the report issued
    last month from the Department of Health and Human Services,
    which called prescribers ``the gatekeepers for preventing
    inappropriate access.'' But providing educational material on
    safe opioid prescribing, even if it is free and readily
    available, won't be enough. To change doctor prescribing
    behavior we need first to acknowledge the enormous incentive to
    prescribe opioids, and the disincentives to stop prescribing.
    Many doctors are afraid that a patient will sue them or
    complain about them if they don't prescribe opioids, even when
    the doctor knows the opioid is harming that patient. Also, no
    insurer questions me when I prescribe Vicodin for pain, but if
    I want to prescribe Suboxone to help an addicted patient stop
    taking Vicodin, I typically have to spend hours fighting an
    insurance company to get the prescription approved. Despite the
    Mental Health Parity and Addiction Equity Act that Congress
    passed by a huge bipartisan margin in 2008, many insurers still
    resist reimbursing for addiction treatment.
        The solution to this problem lies in giving doctors
    tangible incentives to prescribe more judiciously, such that
    neither pain nor addiction is undertreated.
        Today, I focused on three areas where I believe this
    Congress can make a positive difference. Number one, require
    revision of healthcare quality measures. Number two,
    incentivize use of prescription drugs monitoring programs. And
    number three, scrutinize accreditation organizations and
    regulatory agencies.
        First, require revision of healthcare quality measures. The
    Centers for Medicare and Medicaid Services and the Joint
    Commission exert enormous control over how doctors practice
    medicine today. Their quality measures set the standard of
    care. In the 1990s, they urged doctors to prioritize pain
    treatment, and that is what we did. Prescriptions for opioids
    skyrocketed, not always to the benefit of our patients.
        CMS and the Joint Commission need to link quality measures
    to treatment outcomes for patients with addictions. This will
    incentivize hospitals and clinics to create an infrastructure
    to screen for and treat opioid addiction.
        Quality measures should also limit excessive prescribing of
    multiple drugs to the same patient, especially of controlled
    medications. A younger person with no objective evidence of
    disease should not be on 10 different medications, yet I often
    see this, and the medications frequently include an assortment
    of stimulants, sedatives, and opioids. Also, far too many
    patients are on a prescription of benzodiazepines at the same
    time as opioids, which greatly increases their risk of
    overdose.
        Finally, CMS and Joint Commission quality measures should
    not be linked to patient satisfactions with opioid prescribing.
    Illness recovery, not patient satisfaction surveys should be
    the arbiter of quality care. Doctors are not waiters, and
    opioids are not items on a menu.
        Second, incentivize use of prescription drug monitoring
    programs. Prescription drug monitoring programs allow doctors
    to see all the controlled medications prescribed to a patient
    beyond just the ones that they prescribe. When physicians make
    use of prescription drug monitoring programs, prescription drug
    misuse decreases. Monitoring programs don't merely limit access
    to opioids when they should not be prescribed. They allow for
    patients who really need them to get them. The question is how
    to get more doctors to use these databases. By some reports,
    only 35 percent of prescribers use these databases. Here are
    some ways to incentivize doctors to use prescription drug
    monitoring programs. Make it a billable medical service.
    Mandate education on use of PDMPs when physicians apply for DEA
    licensure. Amend privacy laws such as 42 C.F.R. so that
    healthcare providers can freely communicate with each other
    around issues related to prescription drug misuse.
        Third, scrutinize accreditation organizations and
    regulatory agencies. The Joint Commission, the accreditation
    organization which sets standards for hospitals, was
    instrumental in socializing doctors to liberally prescribe
    opioids for pain. The Joint Commission's campaign on treating
    pain was funded in part by Purdue Pharma, whose main product is
    Oxycontin. I do not think Congress should allow a major
    healthcare accreditation body like the Joint Commission to take
    money from the pharmaceutical industry.
        In 2012, the Food and Drug Administration wisely
    rescheduled hydrocodone products to Schedule II, but the very
    same week, the FDA approved the use of Zohydro, a longer-acting
    opioid with high abuse potential, similar to Oxycontin. The
    FDA's own advisory panel recommended not to approve Zohydro,
    yet it was approved anyway. Why? Do we really need one more
    high-risk opioid medication on the market? It seems to me like
    trying to empty a bathtub with a thimble, while filling it with
    a firehose.
        Furthermore, the FDA should live up to its commitment to
    stop approving non-abuse deterrent formulations of opioids,
    which it did not do when it approved Zohydro. And doctors and
    patients need to understand that abuse-deterrent formulations
    make it harder to crush and snort and inject an opioid, but
    they do not prevent ingesting opioids orally at high doses,
    becoming physiologically dependent on and addicted to them, and
    overdosing on them.
        To sum up, Congress can push back against the opioid
    epidemic by requiring revision of healthcare quality measures
    to reduce overprescribing, incentivizing use of prescription
    drug monitoring programs, and scrutinizing accreditation
    organizations and regulatory agencies. All 3 approaches will
    save lives and improve the practice of medicine at the same
    time.
        Thank you again for this opportunity to testify, and for
    your leadership in addressing this public health epidemic.
        [The prepared statement of Dr. Lembke follows:]

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        Mr. Murphy. Thank you, Doctor.
        Now, Dr. Bisaga, you are recognized for 5 minutes.

                        STATEMENT OF ADAM BISAGA

        Dr. Bisaga. Thank you, Chairman Murphy, Ranking Member
    DeGette, and members of the committee, both for holding this
    hearing and for inviting me to speak to you today.
        My name is Adam Bisaga. I am a scientist, working on
    developing new medication strategies to treat opioid
    dependence. I am also educating physicians nationally with
    regards to safe and effective use of these mediations, and I
    have been practicing addiction psychiatry for the past 20
    years.
        I would like to speak on the opioid epidemic from the
    perspective of medical management. And I want to point out how
    our current drug treatment system in the United States is
    outdated; that it does not reflect the scientific progress we
    have made in the past 50 years. Our current system is built on
    the model for treating patients with alcoholism, and it is not
    capable of responding to the unfolding opioid epidemic.
        Opioid addiction is manifested by the compulsive use of
    opioid painkillers or heroin. Patients have abnormal activity
    in several brain regions, and experience powerful urges to use
    that they find very difficult to control. This abnormal brain
    activity can persist for months throughout the abstinence,
    driving high relapse rates. Medications can stabilize opioid
    receptors in the brain; reducing craving, eliminating
    withdrawal, and blunting the patient's ability to feel the
    effects of heroin. These medications work best in conjunction
    with psychosocial therapies to produce long-lasting abstinence.
    This approach has success rates similar to treatments we have
    for many other medical and psychiatric disorders. However, in
    stark contrast, the treatment for most other disorders, very
    few patients with opioid addiction receive evidence-based
    treatment.
        The traditional approach of a brief detoxification followed
    by therapy-only approaches has no evidence for treating
    effectively opioid addiction. In addition, this approach can be
    very dangerous. Patients that do not receive medications to
    block the effects of relapse face an elevated risk of dying
    when they relapse. Certainly, all of us have witnessed it on
    too many occasions.
        So we have three FDA approved medications; methadone,
    buprenorphine, and naltrexone. Methadone activates opioid
    receptors in the brain and blocks the effects of heroin or
    painkillers. Methadone-treated patients use less heroin, have
    fewer medical complications, and have improved social and work
    functioning. In other words, they are able to lead a normal
    life. Methadone is the most effective medications we have,
    however, it is a potent medication, and can cause sedation or
    even death. Therefore, dispensing of methadone is highly
    regulated.
        Buprenorphine works similarly to methadone, but only
    partially activates opioid receptors. It also protects patients
    from overdose risk. Because buprenorphine is safer than
    methadone, less monitoring is needed and it can be prescribed
    by the doctors in their offices.
        Naltrexone, the last medication, is available as either a
    daily tablet or a monthly injection. Naltrexone works
    differently from methadone and buprenorphine. It completely
    blocks opioid receptors, and it is used after detoxification to
    prevent relapse. It has no abuse potential, there is no
    withdrawal when it is stopped.
        Treatment with medication works best as a maintenance
    intervention, without a predefined length of treatment. There
    is no scientific evidence showing benefits to limiting the time
    someone is treated with medication. Opioid addiction is a
    chronic brain disease, and that responds best to chronic
    treatment.
        Methadone, buprenorphine, and naltrexone have all different
    mechanism of action. In this era of personalized medicine,
    patients respond best to medication that are tailored to their
    individual needs. All of these medications are needed to
    adequately address the opioid epidemic. Every American should
    have access to these medications, and with the help of a
    physician, help make an informed decision about their path to
    recovery. Regulations should be put in place to make
    buprenorphine and naltrexone available at every treatment
    center working with patients addicted to opioids.
        More than 100 of individuals, many of them young adults,
    die of opioid overdoses every day. Medication-assisted
    treatment is the best way to reduce the number of deaths on a
    large scale. Addiction is a treatable disorder, and a joint
    effort of health professional, community advocates, and
    policymakers is urgently needed to reverse this tragic trend.
        Thank you for the opportunity to testify.
        [The prepared statement of Dr. Bisaga follows:]

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        Mr. Murphy. Thank you. Appreciate it.
        We are going to try and get Dr. Harris' testimony in, then
    we are going to run to go vote and come back.
        So you are recognized for 5 minutes.

                     STATEMENT OF PATRICE A. HARRIS

        Dr. Harris. Thank you. Good morning, Mr. Chairman and
    Ranking Member, and esteemed members of the subcommittee. I am
    honored to testify today on behalf of the American Medical
    Association. My name is Dr. Patrice Harris. I am Secretary of
    the AMA Board of Trustees. I am also the Public Health Officer
    for Fulton County, which includes Atlanta, and I am a
    practicing psychiatrist with experience in addiction.
        We are indeed in the midst of an epidemic. Physicians are
    deeply disturbed about the rise in overdoses and fatalities
    from prescription opioids, as well as the rapid increase in
    deaths from heroin-related overdoses. The numbers are sobering
    and unacceptable.
        The AMA is working on a number of fronts with many other
    groups to develop recommendations and implement specific
    strategies to confront this public health crisis. Physicians
    are stepping up and taking responsibility to prevent and reduce
    abuse, misuse, overdose, and death from prescription opioids.
    We also need to make sure that our patients who experience pain
    receive the treatment they need. With opioids, if clinically
    appropriate, and that patients who have an opioid use disorder
    have timely access to affordable, comprehensive treatment.
        These are complex problems and there is no one solution. A
    multifaceted, public health strategy is needed. There are key
    components to this strategy. First, physicians must continue to
    amplify our efforts to train and educate ourselves to ensure
    that we are making informed prescribing decisions, considering
    all available treatment options for our patients, and making
    appropriate referrals for our patients with substance use
    disorders. As part of the prescriber clinical support system
    for opioid therapies funded by SAMHSA and administered by the
    American Academy of Addiction Psychiatry, the AMA is developing
    new training materials on responsible opioid prescribing,
    including a focused educational module on opioid risk
    management for resident physicians.
        Patients in pain deserve compassionate care, just like any
    other patient we treat. The dialogue must change to reduce the
    stigma that is associated with pain. We need to increase
    insurance coverage for evidence-based alternative,
    multidisciplinary, non-drug pain management therapies. At the
    same time, we need to support access to opioid-based therapies
    when clinically appropriate.
        Opioid use disorder is a chronic disease that can be
    effectively treated, but it does require ongoing management.
    Physicians need more resources so that evidence-based
    treatments such as medication-assistant treatment in
    conjunction with counseling and other behavioral therapies and
    interventions are more available and accessible to all of our
    patients. There are not enough programs and many are not
    affordable.
        We strongly support lifting the cap and expanding the
    number of patients that office-based physicians can treat with
    buprenorphine and Suboxone, which are major tools in treating
    opioid use disorder.
        Naloxone has saved thousands of lives across the Nation,
    and we strongly support increasing access to it. We encourage
    physicians to prescribe naloxone to their at-risk patients, but
    barriers still exist to using this effective drug to prevent
    overdose deaths.
        Now, one way to reduce one of these barriers is passage of
    Good Samaritan laws so that healthcare professionals, first
    responders, friends, family members, and bystanders who see
    someone who had overdosed can help save a life without fear of
    liability.
        Last, prescription drug monitoring programs can be a
    helpful clinical tool. However, to be most effective and used
    more often, PDMPs need to be real time, interoperable, and
    available at the point of care as part of a physician's
    workflow. In order to get to this point though, Congress needs
    to fully fund these programs so that States can modernize and
    fully fund and staff them.
        So in summary, we know that it is up to our profession to
    provide the leadership necessary to confront this epidemic, and
    we commend this committee's leadership and look forward to
    working with you and other stakeholders to promote evidence-
    based solutions. Our patients deserve no less.
        Thank you.
        [The prepared statement of Dr. Harris follows:]

     [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you, Dr. Harris. And thank you to the
    panel.
        We are in the middle of votes, so we are going to break
    here. It is going to take us about half an hour or so for
    votes. We will come back.
        I just wanted to leave one sobering statistic I have here
    about this. In North America, the number of deaths from plane
    crashes between 1975 and today was 42,495. 1975 through today.
    For the United States, the number of drug overdose deaths last
    year was 43,000. If we were here having a hearing on plane
    crashes, we would need an arena to handle the media. What a sad
    day it is with 43,000 people died in this country last year. I
    feel that we need to have people understand the severity of
    that.
        I thank this panel for your testimony. We will come back
    and ask you questions in a few minutes. Thank you.
        [Recess.]
        Mr. Murphy. All right, we are going to return to our
    hearing here, and as members come in, we will put them in the
    queue.
        So let me start off here. I want to ask a question here.
    Dr. Seppala, a Federal policy prohibits Medicaid matching funds
    being used at inpatient facilities with more than 16 beds whose
    patient roster is more than 51 percent people with severe
    mental illness, and for individuals between the ages of 22 and
    64. Does this affect inpatient substance use disorders clinics
    as well when they have those limitations?
        Dr. Seppala. It sure would, absolutely. Any population that
    is restricted in that manner is not going to get adequate
    treatment.
        Mr. Murphy. So again, making sure we have options
    available, that is a barrier that we need to eliminate.
        Dr. Seppala. Yes, increasing options for addiction
    treatment is really necessary in this country. We don't have
    adequate treatment to address this problem, but we also have a
    public health information problem because, if you look at the
    data from SAMHSA, you will see that over 95 percent of the
    people with addiction don't even know they have it. So that is
    where the initial problem lies. And then of that small group
    that seeks treatment, the biggest problem is access.
        Mr. Murphy. Now, Dr. DuPont, I want to show you a poster
    here. According to the National Institute on Drug Abuse, for
    patients treated with opioid addiction with buprenorphine,
    there is a 92 percent of relapse with an illicit opiate within
    8 weeks after stopping treatment. But look at the increases
    here--this line is buprenorphine--from 2003 to 2012, and it has
    gone up even higher now. Methadone rates have remained fairly
    flat, and heroin rates have increased slightly over this time.
    So I am wondering, given these statistics, and given the huge
    relapse rate with 92 percent, relapse with an illicit opiate
    within 8 weeks after stopping treatment, are we doing enough to
    hold treatment programs accountable to make sure that they are
    getting people the additional treatments to get them on the
    road to recovery?
        Dr. DuPont. Well, that is very important information,
    absolutely, and to me, it shows that buprenorphine or methadone
    are not magic bullets, but they are very attractive to many
    patients and they bring a lot of people into treatment, and
    that is a good thing. I think the question, to me, is what
    happens to them then? And if they just go out and leave the
    program, nothing very good is happening. I am excited about the
    possibility of having a longer-term perspective on the
    buprenorphine patients, and helping them over a longer period
    of time. But the answer is, as you show there, that most stay a
    very short time and the outcome when they leave is that they
    relapse to the opiates.
        Mr. Murphy. And I want to make sure we are all on the same
    page, because what I am pushing for is I want to make sure we
    have a standard here that has hopes of getting people off of
    substances. And I recognize, like any other field, we can't
    reach 100 percent, but our goals should never be less than 100
    percent. But there is a big overlap also with people with
    mental illness.
        Dr. Westreich, so people with mental illness and severe
    mental illness who are actually seeking some substances to numb
    the effects or self-medicate. I see a lot of these in the
    military with folks, and of course, it makes a bad situation
    worse. But then when you have someone who is now addicted, and
    we are trying to wean them off, I would like to think that this
    is not just a matter of substituting an opiate with
    buprenorphine or methadone as a replacement as a road of
    treatment, but really thinking in terms of should they be on
    another medication, a psychotropic drug, something else to
    treat the underlying mental illness. Is this an appropriate
    hypothesis? And two, are we doing this, and if not, why not?
        Dr. Westreich. First of all, I think it is absolutely an
    appropriate hypothesis, and I don't think we are doing it
    enough.
        I think the point is that people who have addictive
    disorders as well as another mental illness need to have very
    sophisticated clinicians who are trained in being able to
    recognize psychiatric symptoms and what they mean. Do they mean
    that the person is simply medicating some uncomfortable
    symptoms? Do they mean that the person has got a freestanding
    psychiatric illness, which must be treated with psychotropic
    medications, or some combination of the above? And so this
    speaks to the training of psychiatrists, psychologists, social
    workers, counselors who need to be trained to recognize mental
    illness symptoms and treat them effectively.
        Mr. Murphy. And we have heard repeatedly in this committee
    that the huge shortage of psychiatrists, psychologists,
    especially child/adolescent ones, to deal with this issue. But
    another concern we have heard is from States that there are
    limitations on--they have funds for substance abuse, and they
    have funds for mental illness, and oftentimes they can't use
    those together.
        Anybody want to comment on that of what we should be doing
    to make sure that they have maximum flexibility in the States?
    Can anybody comment on that? Dr. Bisaga?
        Dr. Bisaga. I think those very often is more of a norm than
    an exception that they go together. So keeping them separate,
    in separate pools of money, doesn't really make sense from a
    clinical perspective. I think we are much more effective when
    we are integrating treatment for mental illness and substance
    abuse by the same provider in the same setting. This is the way
    to have better outcomes.
        Mr. Murphy. Thank you. Anybody else want to comment? Yes,
    Dr. Seppala?
        Dr. Seppala. In our residential settings, in our youth
    settings, so it is about age 14 to 24, over 95 percent of our
    population enters treatment with a coexisting diagnosis of a
    mental illness. In our adult populations, again, a residential
    not outpatient setting, it is over 75 percent. So what we are
    seeing is comorbid psychiatric illness with addiction in our
    treatment settings. It is the norm. We have to treat both.
        Mr. Murphy. Thank you.
        Ms. Schakowsky, you are recognized for 5 minutes.
        Ms. Schakowsky. So I have never seen that chart before and,
    you know, you first look at the chart and you think that
    buprenorphine is a bad idea. I mean that is how it looks. So I
    wondered if anyone----
        Mr. Murphy. Yes, I am just saying we are doing more of it,
    but----
        Ms. Schakowsky. So maybe Dr. Bisaga can speak to that?
        Dr. Bisaga. Well, you know, obviously, this is a very
    complex problem. You know, we see increasing rates of
    buprenorphine prescribing because we have an epidemic and we
    are trying to expand the number of people that are treated with
    this medication. So it tells us a lot of things. It is true
    that not every buprenorphine treatment program is to the best
    standards, but that shouldn't really stop us from trying to
    expand access. We still have a shortage of providers that are
    trained to deliver this treatment. But if this chart had also a
    number of people addicted to painkillers, this line would
    probably go down, which I think speaks something about at least
    the beginning of making a----
        Ms. Schakowsky. But it does it mean that methadone is
    better, or----
        Dr. Bisaga. Well, you know, when you compare methadone with
    buprenorphine in a similar situation, methadone is a little bit
    more potent as a medication, but because it is such a, you
    know, difficult medication to use, it cannot be really widely,
    you know, as easily disseminated to the community as
    buprenorphine, and that is why we are pushing for the
    buprenorphine, again, as a first step of engaging people in
    treatment, protecting them from overdose, and then engaging
    them in the long-term psychosocial recovery-oriented treatment.
        Dr. Lembke. Yes, I would just add that this is a really--I
    just would add a really important difference between
    buprenorphine and methadone is that the methadone--the overdose
    risk with methadone is very high, whereas the unique
    pharmacology of buprenorphine makes it very unlikely for people
    to overdose on it.
        Ms. Schakowsky. Right.
        Dr. Lembke. And so for that reason, there is a huge
    advantage in using buprenorphine, especially since one of the
    primary things we are trying to stop is the number of people
    who are dying due to opioid overdose.
        Ms. Schakowsky. So also let me understand, on the panel, is
    there anybody who doesn't think that the combination of meds
    and psychosocial treatment, that one or the other itself is the
    way to go? No, oK.
        So let me ask Dr. Lembke. Unfortunately, there are a number
    of barriers then for people to get medication, assisted
    treatment, MATs, and one of the barriers is insurance coverage.
    And according to the American Society of Addiction Medicine,
    Medicaid coverage for MAT varies greatly from State to State,
    the chairman was talking about that, with some States not
    covering all FDA-approved medications, imposing prior
    authorization requirements, and fail-first criteria that
    require documentation that other therapies were ineffective. I
    wondered, Dr. Lembke, if you have experienced these issues in
    your practice, both of Medicaid and private insurers?
        Dr. Lembke. So that is very common with both Medicaid and
    private insurers that when you try to get coverage for
    addiction treatment, they give you the huge runaround, you have
    to talk with somebody on the phone for hours regarding medical
    necessity, whereas that is not true if you are prescribing a
    pharmacologically identical medication, or a very similar
    medication, for the treatment of, for example----
        Ms. Schakowsky. So what does that----
        Dr. Lembke [continuing]. Pain.
        Ms. Schakowsky [continuing]. Really mean for patients?
        Dr. Lembke. Well, what that means is that you want to get
    addiction treatment for patients who are struggling with the
    disease of addiction, and you can't get insurance companies to
    pay for it, which means that patients don't access the
    treatment. All you are left with is non--you know,
    interventions outside of the infrastructure of medical
    institutions, which is primarily just the 12-step movements. So
    it is a huge problem.
        Ms. Schakowsky. And so in your opinion, and anybody else
    can weigh-in on this too, would increased coverage of MATs help
    more individuals to remain in recovery?
        Dr. Lembke. Well, what happens now is that--what I see with
    private insurers is that they say they cover MATs, but then,
    basically, they have all kinds of loopholes whereby they can
    deny that coverage, and they just make it so incredibly
    bureaucratically cumbersome in real time, you know, in the
    trenches, that you end up throwing up your hands. And once you
    start somebody on buprenorphine, you don't want to just
    suddenly not have it available to them, but that happens
    frequently because all of a sudden, you have been denied
    coverage. It is insane.
        Ms. Schakowsky. Anybody else want to comment on that?
        Dr. Seppala. Yes, I could speak to it.
        Ms. Schakowsky. Yes, Dr. Seppala.
        Dr. Seppala. We have had to increase our own infrastructure
    just to have enough people involved to get these medications
    approved.
        Ms. Schakowsky. You are talking about people who spend time
    on the phone and----
        Dr. Seppala. Yes. Yes.
        Ms. Schakowsky. OK.
        Dr. Seppala. So trying to limit our doctors' involvement
    and have other people do that, usually nurses, but it really
    has required adding FTEs to what we do. So increasing our
    expenses just to get these medications approved by insurance
    companies.
        Ms. Schakowsky. And eventually you do get them approved
    usually?
        Dr. Seppala. I would say usually is a good description. Not
    always.
        Ms. Schakowsky. Yes. OK.
        Dr. Harris. And I also would like to add that it is
    increasing coverage for MAT, but it is also increasing coverage
    for the other interventions; the behavioral interventions, the
    therapies, cognitive behavioral therapies, the other therapies
    that we know compliment MAT and work well.
        Ms. Schakowsky. And those are hard to----
        Dr. Harris. It is very difficult to----
        Ms. Schakowsky [continuing]. Get approved?
        Dr. Harris [continuing]. Get coverage for that, yes.
        Ms. Schakowsky. Thank you. OK, I don't know, can Dr.----
        Dr. Bisaga. Can I--yes, on the other hand, another trend is
    that insurance companies know that this saves them money.
    Evidence-based treatment saves money. So we also see a trend of
    them declining to pay for the programs that do not offer
    evidence-based treatment; psychotherapy and the medication and
    on the 12-step. So that is another good trend. So hopefully we,
    you know, we can use the data to inform how we should actually
    invest in the public healthcare.
        Ms. Schakowsky. Thank you so much. Thanks, Mr. Chairman.
        Mr. Murphy. Well, I want to follow up on what she is
    saying. It is very important, especially in light of the mental
    health parity. So we want to make sure that evidence-based care
    is there. Medication-assisted treatment is there as part of a
    protocol, psychosocial therapy is part of a protocol, using the
    proper things. Just talk therapy in a general concept isn't
    going to work, it has to be very focused with someone who
    understands addiction. And part of our challenge here is, we
    had previous testimony from some places just talking about pill
    mills where doctors are just cranking out lots of medication,
    and since 90 percent of people we found weren't in any kind of
    treatment, and of those getting treatment, only 10 percent of
    that were getting the evidence-based treatment. It sounds like
    what you are saying the insurance companies are kind of
    throwing the baby out with the bathwater here, responding to
    Ms. Schakowsky's questions, making it very difficult to get
    proper treatment. And since most people aren't getting
    treatment anyway, shouldn't they be focusing on something else?
    Dr. DuPont?
        Dr. DuPont. A point about that--that the evidence of what--
    what is the evidence we are talking about, and the evidence for
    evidence-based is what happens to the person while they are
    taking the medicine. It is not what happens to them later.
    Where do they go? And what I am encouraging is to have
    evidence-based assessment of what the consequences are--what
    the long-term outcome is of all of these treatments. Which
    treatments are getting people into stable recovery, which are
    not. And that is not what we are doing now. Our evidence is
    what happens while they are there, in the face of the fact that
    you have very rapid cycling through these programs. If we are
    talking about dealing with an epidemic, we have to deal with
    those people as individuals for their lifetimes, for long
    periods of time. That is why I say 5 years. So evidence-based
    of while they are in the treatment is good, but it is not what
    we really want. Is it evidence of getting them into stable
    recovery or not----
        Mr. Murphy. Thank----
        Dr. DuPont [continuing]. That is the question that has to
    be asked.
        Mr. Murphy. Thank you.
        Ms. DeGette, 5 minutes.
        Ms. DeGette. Thank you very much.
        Dr. Lembke, I am listening with interest to this
    discussion, and others might have also input on this, but why
    is it so difficult to get insurance companies and others to pay
    for these appropriate treatments?
        Dr. Lembke. My belief is that essentially insurance
    companies do not want people on their panel who have chronic
    lifetime diseases that will need chronic lifetime care, and
    they essentially view the addicted population wrongly as folks
    who cannot get better and will always need lots of medical
    care. And it is really an untrue bias that insurance companies
    have that mirrors a bias that society has, because the truth is
    when you get addicted persons into quality addiction treatment,
    they have about 50 percent response recovery rates, which is on
    par with recovery rates for depression and many other chronic
    illnesses----
        Ms. DeGette. So----
        Dr. Lembke [continuing]. With a behavioral component.
        Ms. DeGette. So you think that they don't want to--they are
    reluctant to get--pay for a treatment plan if they think that
    it could be a chronic long-term plan?
        Dr. Lembke. Yes, that those people are going to be----
        Ms. DeGette. Yes.
        Dr. Lembke [continuing]. Costly for them. They don't----
        Ms. DeGette. Right. And----
        Dr. Lembke. They don't want to----
        Ms. DeGette. And you think one of the solutions might be
    putting more patients on those boards?
        Dr. Lembke. Patients on----
        Ms. DeGette. People who have dealt with recovery and so on,
    is that what I am hearing you saying?
        Dr. Lembke. On what boards?
        Ms. DeGette. On the insurance review boards.
        Dr. Lembke. You know, it is a weird group thing that
    happens even when you have physicians who you have to talk to
    who are representing insurance companies, their mandate is to
    withhold care. Their mandate is to pay for as little as humanly
    possible. I mean I can tell you horror stories about hour-long
    conversations I have had with physicians representing insurance
    companies who then denied care in cases where care was----
        Ms. DeGette. So----
        Dr. Lembke [continuing]. Obviously needed.
        Ms. DeGette. So, Dr. Bisaga, I want to follow up with that
    because in your testimony, you said that very few of the
    patients with opioid addiction receive treatments that have
    been proven to be effective, and you said the treatment most of
    them were receiving is outdated and mostly ineffective. What
    kind of treatment is that that people are receiving that is
    just not working?
        Dr. Bisaga. Right, so we just had a wonderful example from
    Dr. Seppala talking about kind of the best possible treatment
    that marriages very efficiently 12-step with the medications.
    This is really, really exception. This is 1 of the 1 percent.
    Majority of people, the treatment consists of going to the
    hospital, getting detoxified, and then trying to be encouraged
    to go to the 12-step meetings without being told even that
    there are evidence-based medications.
        Ms. DeGette. So what it is, it is kind of a truncated
    treatment. It is like we are----
        Ms. Bisaga. Again----
        Ms. DeGette [continuing]. We are going to give you some--
    maybe we are going to give you some medication, we are going to
    make--we are going to tell you to go to this treatment, then
    you are on your own.
        Ms. Bisaga. Right. So we only going to detox you, and we
    expect you--that you going to stay abstinent. There is no
    information about the evidence-based medications. After
    detoxification, opiate blocker could be a way to maintain----
        Ms. DeGette. OK. So there is not--there is not even
    medication involved in most of these.
        Ms. Bisaga. No. Many inpatient detoxifications do not put
    people on medication. It----
        Ms. DeGette. They just detox them----
        Ms. Bisaga. Yes.
        Ms. DeGette [continuing]. And then they----
        Ms. Bisaga. Detox them and sell them to 12-step groups.
        Ms. DeGette. OK.
        Ms. Bisaga. It is changing, but slowly.
        Ms. DeGette. And do all of the rest of you agree with that,
    that that is what is going on for the most part? Yes? OK.
        Now, Dr. Westreich, you said in your testimony, patients
    and their families need to know that detoxification treatment
    and drug-free counseling are associated with a very high risk
    of relapse. So it is sort of the same question that I was
    asking Dr. Bisaga, do you think that patients enrolling in
    programs that employ this approach are being given adequate
    information to make informed decisions about their treatment?
        Dr. Westreich. Well, I think that is exactly the question.
    At the middle and end of that treatment episode, they should be
    given information about their particular case and what their
    likelihood for relapse is, and what possible treatments are,
    including medications, including abstinence models, and be able
    to make an informed decision based on having those treatments
    available to them. And my concern is when they are not
    available, the person cannot make an informed decision.
        Ms. DeGette. Right. If you never have MAT offered as an
    alternative, you can't have a complete program.
        Ms. Westreich. Exactly.
        Ms. DeGette. And this is not just your idea or the other
    esteemed members of this panel, this is like scientifically
    proven, right?
        Dr. Westreich. Yes.
        Ms. DeGette. Yes.
        Dr. Lembke. Can I just add one thing?
        Ms. DeGette. Please.
        Dr. Lembke. You know, MAT works for some people, it doesn't
    work for everybody----
        Ms. DeGette. Right.
        Dr. Lembke [continuing]. And what some people who are in
    the acute crisis of the disease of addiction need is to be put
    into a hospital so they can detox, and hopefully then get
    routed to some kind of behavioral or residential treatment. And
    that is also very hard to get insurance companies to pay for.
        Ms. DeGette. Right, and if you can find a program to put
    them in.
        Dr. Lembke. Even to put them in the hospital----
        Ms. DeGette. Exactly.
        Dr. Lembke [continuing]. I mean, even to put them in the
    hospital for 3 or 4 days is very hard.
        Ms. DeGette. And, you know, let me just say, Mr. Chairman,
    I really appreciate this hearing because this is exactly what I
    have been trying to say is, it is not a one-size-fits-all
    solution for these patients, there are different types of
    solutions, but if you take out one of the programs that really
    works, like MAT, or the MAT plus the intensive long-term
    counseling, not only are you going to have a failure rate, but
    you are also going to have deaths. So thank you.
        Mr. Murphy. And even that is difficult for them to get.
        Dr. Burgess, recognized for 5 minutes.
        Mr. Burgess. Thank you, Mr. Chairman. And I do have a
    number of questions for Dr. Harris. Thank you for being here
    today. I may end up submitting those to you in writing and ask
    for a written response because I do want to use part of the
    time that I have available to get on my soapbox. That is what
    we do here.
        This is not quite the appropriate hearing, but this
    subcommittee does have jurisdiction over the Food and Drug
    Administration, and several times we have had the Food and Drug
    Administration in, I have asked the question why we cannot have
    the availability of naloxone or Narcan as an over-the-counter
    purchase. Why Federal law prohibits dispensing without a
    prescription, but why? No one is going to abuse Narcan. Narcan
    can be a lifesaving measure. Sure, I want first responders,
    police departments, EMTs, I want them to have it available in
    their armament when they arrive on the scene of a person who is
    unconscious. Are there--I don't think we will be inducing
    anyone to misbehave by having a rescue method at their
    disposal.
        So, Mr. Chairman, I just wanted to get that out of the way.
    I do think the Food and Drug Administration needs to work on
    this. I think this is one of the things that--I mean you
    referenced in your opening statement the tragedies that occur
    happen in my suburban area as well. The tragedies that occur
    when we lose a young person through what presumably is an
    unintentional opiate overdose.
        And then the other thing that I just feel obligated to talk
    about, I mean I was in practice for a number of years. Covered
    for other doctors, as we all do, and I know there were times
    that I was burned by a patient who was exhibiting drug-seeking
    behavior and I didn't immediately recognize it. I tried to
    guard against that. In fact, the latter years that I was in
    practice, I would not fill a prescription of a patient I did
    not know over the phone, I would go to the office and look up
    their chart. If I couldn't find their chart, yes, that might be
    on us because we didn't have electronic records, we had paper
    charts, I would offer to meet that patient in the emergency
    room and evaluate their signs and symptoms, and if appropriate,
    prescribe a medication. Suffice it to say, most of the time
    that did not occur and the patient was not willing to come in
    and spend the time required.
        But look, we have prescription drug monitoring programs.
    And I will tell you one time just sticks out in my mind how
    frustrated I was. Called in a prescription for a patient with a
    very plausible story, and the pharmacist said, you know, you
    are about the fifteenth doc that has called in medicine for
    that patient this month. And I said, what, that is crazy. Well,
    cancel the prescription. He said, you have already called it
    in, I will fill it for her when she shows up, but I just
    thought you ought to know. And I forget the number he gave me,
    but it was an astounding number of Tylenol III that this
    patient had received during the month. And forget the codeine
    part of the prescription; this was a multiple times lethal dose
    of acetaminophen that, if somebody had actually ingested it,
    their liver was long gone and someone would be paying for a
    liver transplant. We have prescription drug monitoring
    programs. We have one that was passed by this committee, called
    NASPER, and President Bush signed it into law in 2005. There is
    a competing program that was done by the appropriators. That is
    not your problem, that is our problem. But, Mr. Chairman, it
    just underscores how we need to fix that. And now, we ask the
    American people with the Stimulus Bill to fund this large
    electronic health records, and do we have the interoperability
    so a doc in practice would know what that patient is taking? We
    don't really have the availability of getting that because of
    HIPAA, there are some privacy concerns. Somehow we need to
    bridge that gap, and I really would welcome anyone's comments
    on the panel about the prescription drug monitoring aspect.
        Dr. Westreich. I would like to comment----
        Mr. Burgess. Yes, Doctor.
        Dr. Westreich [continuing]. On both. First, I agree 1,000
    percent about Narcan, having that available not only to first
    responders but to families of people who have members who use
    opioids. I agree with you, and I don't see any reason why that
    can't happen.
        Regarding the prescription monitoring programs, we have one
    in New York State where I practice, where I am obligated to
    look at it each time I prescribe an opioid medication. There is
    one in New Jersey which covers Connecticut and Delaware, but
    there is no national one. So someone can be getting an opioid
    medication in the State next door and I would have no idea from
    the pharmacy monitoring program. We need to have a fully
    national program, and it would be enormously helpful for
    treating our patients.
        Mr. Burgess. Our other problem is we have to--yes, Dr.
    Seppala? I am sorry.
        Dr. Seppala. I would like to support both of your
    recommendations, Congressman. We should have over-the-counter
    naloxone. It is a very innocuous drug, you know that, and there
    are not many side effects or problems you could cause with it.
    It does one thing; it blocks opioid receptors in a very safe
    manner.
        And as far as the prescription drug monitoring programs,
    when they are not mandatory, as was described earlier, only
    about 33 percent of the docs use it, so there is not adequate
    information on them. We need it to be mandatory and across
    State lines. So I agree with both.
        Mr. Burgess. Yes, Dr. Harris?
        Dr. Harris. Yes, PDMPs are a valuable tool. They have
    valuable information, important information for doctors who are
    prescribing, however, they have to be easy to use, available at
    the point of care. Totally agree with interoperability.
        I do want to say that we have some data, we look across the
    States, and where they are readily available at the point of
    care and have real-time information, doctors are using them,
    but where they are more burdensome and don't have real-time
    information, doctors are not using them as much. And so I think
    the AMA is actually--I chair a task force looking at this
    issue, and one of the things we might come up with is perhaps
    what should a model PDMP look like, to give guidance on that so
    that doctors increase their use of PDMPs.
        Mr. Burgess. Thank you.
        Mr. Chairman, I will yield back.
        Mr. Murphy. Yes, just as a follow-up. So what you are
    describing here is just to even know when you are prescribing--
    you know if a patient has already been prescribed opioids by
    their physician, to be able to follow that up. And then in
    addition to that--but you are also treating someone with an
    addiction disorder. That is the 42 C.F.R. Part 2 issue.
        Dr. Lembke, can you comment on that about how we need to
    make modifications to that? I am thinking that our former
    colleague, Patrick Kennedy, is always on me saying we have to
    fix this problem too, that someone has--getting addiction
    treatment, they are not even going doctor shopping, they are
    actually trying to get help, and they go see another doctor,
    the doctor doesn't know they are getting addiction treatment
    and he says, here, take this Percocet, take this. Can you
    comment on that, Dr. Lembke?
        Dr. Lembke. Yes, so the phenomenon we essentially have
    today is that on one side of the aisle in a medical institution
    you have people prescribing Vicodin, on the other side of the
    aisle you have people trying to get them off of it, and each
    other doesn't know what the other is doing because, according
    to 42 C.F.R., we cannot--it is a higher burden of privacy than
    even HIPAA, if someone is getting substance use treatment, we
    cannot communicate without their expressed consent to another
    provider that they are getting that treatment.
        This Code of Federal Regulations was implemented more than
    2 decades ago with good reason. What was happening was that
    police were going into methadone maintenance clinics and
    essentially arresting people who were trying to get treatment
    for their addiction. And so it was a higher burden on privacy
    so that people wouldn't resist going into treatment because
    they were afraid of being exposed around their addiction. But
    in this day and age of electronic medical records, and this day
    and age of prescription drug misuse, most importantly, as well
    as just the fact that we are trying to advocate for addiction
    being a disease, and we can't advocate for addiction being a
    disease if we treat it differently from other diseases. So I
    believe we have to amend 42 C.F.R. so that doctors can
    communicate openly about which patients are possibly misusing
    the drugs that they are prescribing to other providers caring
    for those patients.
        Mr. Murphy. Other people agree with that?
        OK, Mr. Tonko, you are recognized for 5 minutes.
        Mr. Tonko. Thank you, Mr. Chair.
        All of us on this dais are seeing the toll that addiction
    can have on our communities. However, with that in mind,
    insufficient data are available in the field of opioid
    addiction treatment. I would like to better understand from our
    panelists just how we should move forward with investments in
    research. How should those efforts be utilized to improve
    recovery outcomes?
        Dr. DuPont, you have been treating opioid addiction for a
    long time. How would you advise us in terms of research
    dollars--we obviously need to do more in research, I would hope
    that would be an agreement across the board here, but how
    should those dollars be invested, in what ways are they most
    beneficial?
        Dr. DuPont. Evaluations of outcomes over a longer period of
    time. But I want to bring up something that I don't think has
    been clear here, and that is no matter what happens with
    prescription drugs, there is a robust heroin market and it is
    getting bigger all the time, and I think it will be a huge
    mistake for us to think that the only problem we have is
    prescription drugs. That is contributing to it, that has kicked
    it off, but now it has taken off in an entirely different
    direction and it is huge, and I think we underestimate the
    power of heroin distribution in the country that produce high
    quality products at low cost, and that is just going to get
    worse. So I think that is something to keep in mind.
        The other thing is----
        Mr. Tonko. But that supply and demand equation is something
    we hear about all the time. I hear about it all the time in the
    district. People are very concerned.
        Dr. DuPont. Well, it is a very, very serious problem, and
    it drives me nuts that people who want to solve the drug
    problem by legalizing drugs. I say let's start with heroin. We
    are going to solve that problem by legalizing it? Give me a
    break. But it is a very serious problem for us to deal with.
        But the other point is, most people who have this problem
    do not see that they have a problem. They do not want
    treatment. When they go to treatment, they drop out of
    treatment. To get good long-term outcomes the answer is not
    just in the treatment. You can improve treatment and improve
    treatment and improve treatment, and you are still going to
    have tremendous frustrations getting people in, and keeping
    them in and keeping them clean when they leave. And that is why
    I studied the physicians health programs, because what those
    programs do is monitor the people for 5 years. And the
    physicians don't have a choice of getting out once they are
    diagnosed, and it is interesting how positive they are about
    that. I think one of the things this committee could do is look
    at the environment in which the choice is made to use and not
    to use, and think about what can be done to change that
    equation.
        One area of tremendous potential is the criminal justice
    system, where there is the kind of leverage that you have. You
    have 5 million people on probation and parole in this country,
    many of whom are opiate dependent, but I think also for
    families to understand that they have to be concerned about
    somebody who has an opiate problem, and not--and essentially
    manage that environment for that person, because that person's
    judgment is changed by the addiction and they are helpless on
    their own without somebody intervening. So I would suggest 2
    things. One is look long-term, and the other is think about the
    environment in which that is going on, and think about ways of
    using the environment to promote recovery.
        Mr. Tonko. And to our other panelists, are there ways that
    research can be connected into positive treatment outcomes?
        Dr. Seppala. Absolutely. It should be one of the focuses of
    most research to look at positive treatment outcomes, and
    actually negative treatment outcomes, to define both for the
    rest of the field so we know what we are doing, and we can
    individualize care in a much better way. Right now, there is no
    research that shows who should be on buprenorphine versus who
    should be on Vivitrol. It has not been defined. Our field is
    limited in regard to the type of research to make those
    decisions. We need a great deal more research in this field.
        Mr. Tonko. Is there anything that has been planted as a
    seed that needs to be grown to a bigger program of research, or
    is it just being avoided in general?
        Dr. Seppala. I think research dollars are so limited across
    medicine right now that it is really hard to get----
        Mr. Tonko. Well, there is a theme around here at times to
    cut research, which I oppose. I think it is the wrong path,
    but----
        Dr. Seppala. We have a huge system, we are in 16 States,
    and we don't even have the infrastructure to gain grants from
    NIH. We can't do that, we have to partner with people to get
    research dollars. The research we are doing on this program I
    described is self-funded. We can't get the money we need to do
    the research in our setting.
        Mr. Tonko. Anyone else on the panel? Yes, Doctor.
        Dr. Bisaga. Well, I mean, you know, the most of the rest of
    the medicine is moving towards personalized medicine or
    precision medicine, but we are trying to find out which
    treatments work best for which patients so we can avoid wasting
    time giving ineffective treatments. And this is very relevant
    to this hearing because we have four methods of treatment;
    three medication and maybe some people will even respond to no-
    medication treatment. And we have a lot of people affected by
    the illness. So investing in pursuing, again, research, which
    patients should be treated with which medications, which can be
    done probably, would be the very smart way to use the research
    dollars to address this, you know, huge problem.
        Mr. Tonko. I, with that, yield back.
        Mr. Murphy. Thank you. Excellent questions.
        Ms. Brooks, 5 minutes.
        Mrs. Brooks. Thank you, Mr. Chairman, and thank you so much
    for holding this critical hearing.
        Last year in Indianapolis, an area that I represent, and to
    the north, we saw massive spikes, and I heard from our public
    safety officials, and I a former United States Attorney, about
    the increased use of heroin in our communities. I met with law
    enforcement officials first before meeting with treatment
    providers to see what they were seeing, and one of the greatest
    frustrations some of the law enforcement officials in
    Indianapolis had, who have now been trained in the use of
    Narcan, it is a pilot project being used in the city, they
    would save someone, and about 2 weeks later save them again.
    Same person who they have saved their life, they are now
    getting saved once again by even the same officer. And what
    they were so frustrated about is, where are the treatment
    providers. You know, we are saving them, you know, they are
    taken to the hospital, where is the system, what are we doing.
        Then when I met with treatment providers, obviously, as we
    have learned, I mean it is very, very difficult, A, to get
    people to stay in treatment, to realize they need the
    treatment. Drug courts sometimes work, and not enough
    communities have drug courts, although I have recently heard
    that drug courts--some drug courts are not allowing medication-
    assisted treatment. I am curious what your thoughts are about
    that, because we fund drug courts. Much of their funding comes
    from Federal grants. And so I think that is something that we
    ought to realize that when these patients are going in to the
    drug courts, which can save their lives, there is no question
    about it, would like your comments on that. And then finally, I
    just would ask all of you, because physicians, whether they are
    in the ER, whether they are part of treatment providers, or
    whether they are treating them for something else, what more
    should we be doing to educate our physicians, because I have
    also prosecuted physicians who became pill mills for
    communities, this was back in the Oxycontin days, but what do
    we need to do to better educate physicians and psychiatrists
    about how to treat addictions, because we are not there, we are
    not even close to being there. And I applaud all of you for
    your work. And I guess I would start with the drug treatment
    courts that we actually may have some leverage over. I don't
    know who would like to comment about drug treatment courts.
        Dr. Bisaga. If I may. You know, I have a lot to say on the
    issue of these topics, but this is very important topic because
    a lot of people who are under criminal justice system custody
    really are there because they have a disease that affects their
    functioning and may cause them to do criminal things, and the
    way to help them get out of the custody is to treat their
    medical illness, which is an addiction. However, the drug
    courts and the judges still, I think, tend to think in the old
    days, thinking that the way to treat them is to send them to
    the medication-free treatment, not medication-assisted
    treatment. So we are working with the Bureau of Prisons, and
    hopefully you guys can help with that tool, to encourage them
    to use evidence-based treatment when they are making decisions
    about the medical treatments. It can be done in combination
    with the decision about the, you know, criminal justice with
    ability. So----
        Mrs. Brooks. Because, you are right, our prisons, which we
    also fund, obviously, as people are coming out of prison,
    probably one of the top reasons they recidivate and are back
    within a short period of time is they didn't have their
    addiction dealt with, and they are--anyone else like to
    comment----
        Dr. Westreich. Yes, as----
        Mrs. Brooks [continuing]. Or all of----
        Dr. Westreich. As to drug courts, I mean I would say on
    both of your questions, education is the key. I think drug
    courts are great. I think judges and lawmakers need to be
    educated about addiction itself and not practice medicine. In
    the same way, we clinicians need to be educated about law and
    about the necessity for a holding structure of people who are
    addicted. So I think drug courts work well when everyone is
    educated about what they are doing, about therapeutic
    jurisprudence, which is what that is.
        Secondly, as far as educating doctors, I agree 100 percent.
    I think we need to have much better efforts both through the
    auspices of groups like mine, and organized medicine in
    general, to educate not only psychiatrists but primary care
    doctors and all physicians about prescribing practices, and
    then about recognizing and treating addiction in an evidence-
    based manner. So education in both spheres, I think.
        Dr. Lembke. We give a lot of lip service to addiction being
    a chronic medical illness, but we don't actually treat it like
    one, either in the medical system or in the criminal justice
    system. I cannot imagine a judge working with someone in the
    criminal justice system saying you have to go off your diabetes
    or your hypertension meds, otherwise you can't be in this court
    system. We wouldn't accept that, and yet we accept them saying
    to these individuals you can't be on Suboxone.
        So obviously, we don't regard it as an illness. Even within
    the medical system, doctors do not treat it like a medical
    illness. So we need a huge frame shift. And I think education
    is really important, but unless, again, you incentivize doctors
    and judges, and whoever it is, to really treat it like an
    illness and create the infrastructure to treat it like an
    illness, you are not going to make any headway.
        Mrs. Brooks. And while my time is up, Mr. Chairman, I
    believe Dr. Seppala would like to address that question as
    well, if that is oK. Thank you.
        Dr. Seppala. I would. We have had a couple of leaders of
    the drug court system come and look at our program, and they
    have held a fairly conservative stance in regard to the use of
    Suboxone and other maintenance medications for opioid
    dependence over time, but I think they are shifting. So I
    believe that you could play a huge role in pushing them along
    in this direction. They need to go there.
        Mrs. Brooks. And their education.
        Dr. DuPont. Could I just make one quick comment about this?
    In the physicians health programs, about \1/3\ of the
    physicians in those programs are opiate addicts, about \1/2\
    are alcoholics, and the rest are other drugs. We looked at what
    happened to the opiate addicts' physicians, none of them were
    given Suboxone or methadone, and they did as well as the
    alcoholics in their long-term outcomes. They did very, very
    well without medication. Now, that is a specialized population,
    I don't want to generalize it, but I just want to get that
    clear.
        I would suggest in the drug courts that the committee
    encourage the drug courts to actually look at the question,
    like they are doing in Hazelden, and see for themselves, do
    they get better results when they offer that as an option. I
    think that is a researchable question. I think it could go
    either way. I don't know what would happen, but I think that
    would be the way to talk about it with them, and I think they
    would be receptive to that.
        Mrs. Brooks. I want to thank you, Mr. Chairman, for that.
    And I think with respect to educating judges and lawyers, while
    you are focused on physician addicts, there are plenty of
    judges and lawyers who also could share their knowledge and
    experience, and maybe help better educate our judges and
    lawyers.
        I yield back.
        Mr. Murphy. Thank you.
        I now recognize Mr. Kennedy for 5 minutes.
        Mr. Kennedy. Thank you, Mr. Chairman. I want to thank the
    chairman and the ranking member. I want to also thank an
    extraordinary group of panelists for your dedication to this
    issue, which is really--it is a preeminent group that we have
    here. So thank you for your testimony today. It has been a big
    help, I think, as we try to think through these issues.
        And, Chairman, I also want to thank your kind comments
    about my cousin, Patrick, as well. This has obviously been an
    issue that has been very close to his professional life's work,
    and I appreciate your recognition of those efforts.
        A number of you have talked about incentives over the
    course of the testimony today. And, Dr. DuPont, you also
    mentioned the impact of heroin and the heroin trade. I, like my
    colleague, Ms. Brooks, was a prosecutor--I was a State
    prosecutor. I ended up prosecuting an awful lot of property
    crimes; breaking and entering cases, that were more--it was
    kids, 18, 20, 22 years old, that were breaking into 15 cars in
    a night to try to feed an Oxycontin addiction. Massachusetts
    has been struggling with this for years now. I met recently
    with the DEA and, you know, rough numbers, but they describe
    the drug trade with Mexico alone to be in the order of $30
    billion a year. And a big percentage of that is heroin. So
    until we kind of wrap our minds around the fact that, as the
    street market for Oxycontin is 80--or essentially, a buck a
    milligram, so $80 a pill, but you can get heroin for $3 or $4 a
    bag, there is a very strong economic incentive to push you into
    heroin. And I think I have said this before at these hearings,
    meeting with local law enforcement, meeting with Federal law
    enforcement back home, a widespread recognition, we will not
    arrest our way out of this problem. So the question becomes, if
    it is a demand-based epidemic, because people are addicted and
    that is fueling either because of overprescription, because of
    easy access, and then a migration towards heroin, how do we
    make sure that we don't even get there in the first place?
        So, one, I wanted to get some thoughts from you, Dr. DuPont
    and Dr. Lembke, as to what we can be doing to make sure that
    your efforts here hopefully one day aren't necessary, but then
    two, we have touched on this a little bit, in my study of
    this--people will follow incentives, and the Federal Government
    has systematically underinvested in substance abuse treatment
    and in mental health now for decades. I hear from our
    hospitals, our doctors, our patient groups, everybody, our
    judges, our court system, there are not beds for people to get
    treatment. So if we start reimbursing for--if you start to put
    the economic incentives in for doctors to get compensated
    adequately for their time for there to be actually treatment
    facilities, you will see more beds, you will see more treatment
    facilities, you will see more wraparound services. So I was
    hoping to get both of you to comment on that as well, and
    what--I guess bifurcated question to start, what should we be
    doing to--hopefully to make sure we actually one day don't need
    all of these services you are talking about, and in the
    meantime, what incentives--where should we be really focused on
    these incentives to build up and flush out so that people can
    get the continuum of care that they need?
        Dr. DuPont. Well, I think one thing to focus on is the drug
    problem is not just about heroin or opiates; we have a very
    serious drug problem across a very broad spectrum to deal with.
    But I also want to just say it has been my privilege to work
    with Patrick often, and he is a genuine hero of our field and a
    hero to me. An extraordinary guy who is making a tremendous
    contribution.
        And I want to go back to those young men you were arresting
    and prosecuting. One of my preoccupations is the use of the
    criminal justice system in what was described as therapeutic
    jurisprudence. When that person is arrested, there is an
    opportunity to change his life direction in a very positive
    way. And one of the most striking programs about this is called
    Hope Probation from Hawaii, which uses the leverage of the
    criminal justice system to promote recovery. I visited out
    there, and let me tell you something, the treatment programs
    love the people that they get from Hope probation because they
    do stay, they do pay attention, they do get better, because
    they are required to be drug-tested for their probation. And so
    it makes treatment work like that. And I think that there is a
    real opportunity to use that as an engine for recovery that
    should not be overlooked when a person is out of control. But I
    don't think we are going to treat our way out of this either.
    We have to deal in an integrated way with a very complex
    problem, and the problem is the drugs really work. People do
    not understand the potential. They think somehow there is--some
    small percentage of the population is vulnerable to drug
    addiction. That is not correct. It is a human phenomenon, it is
    a mammalian phenomenon. And when there is access to these
    drugs, an awful lot of people are going to use them, and a lot
    of the people who use them are going to be stuck with that
    problem for the rest of their lives. This is a very big
    problem, of which this is a very important part.
        Mr. Kennedy. I am already over time, but if I could ask you
    to just answer as briefly as you can.
        Dr. Lembke. Just briefly. I really appreciate your emphasis
    on incentives, particularly in changing doctors' behavior and
    creating the infrastructure to treat the illness. Even if you
    don't believe addiction is a chronic illness, we need to
    pretend like it is because, from a practical perspective, if we
    don't, we will just make people sicker, we won't make them
    well.
        And then what is really driving the recent heroin increase
    is young people, so I absolutely agree that we need to put our
    resources toward youth, and not just for the short term, but
    they need to learn how to live differently in the world and
    whatever that takes, changing the structure of their lives and
    their friendship groups, giving them jobs, socializing them in
    a better way to adapt to contemporary culture is, I think, you
    know, where it is, not just short-term and long-term.
        Mr. Kennedy. Thank you.
        Thank you, Mr. Chairman.
        Mr. Murphy. And, Ms. Clarke, you are recognized for 5
    minutes.
        Ms. Clarke. Thank you, Mr. Chairman. And I want to thank
    all of our witnesses for giving this committee the benefit of
    your expertise and experience today.
        I would like to focus my questions on the prevention side
    of the equation. I know we have discussed the array of access
    points to heroin and opiates, and I would like to focus us back
    to the universe of prescribed opiates.
        According to the National Institutes on Drug Abuse, the
    number of prescriptions for opiates in the United States
    escalated from 76 million in 1991, to about 207 million in
    2013. Between 2000 and 2010, there was a fourfold increase in
    the use of prescription opiates for the treatment of pain. The
    uptake in prescriptions for opiates has been accompanied by a
    corresponding increase in the number of opiate-related overdose
    deaths.
        So let me start with Dr. Seppala. My question to you is,
    are opiates being overprescribed, and I want to get to the why
    if that is the case?
        Dr. Seppala. Yes, they are being overprescribed, and they
    are being used for purposes that they are not necessarily
    proven to be effective for, and particularly when it comes to
    chronic pain.
        Opioids are the best, most powerful painkillers on the
    planet. They are necessary for the practice of medicine and for
    relief of suffering, but primarily, in an acute pain situation.
    Chronic pain studies are not long-term and don't show over the
    long-term the effective relief of chronic pain. Opioids just
    don't work that well, and yet they are being prescribed readily
    for that, so people are taking them for months and years.
        Ms. Clarke. So is there a standard of care as to when it is
    appropriate to prescribe opiates for the management of pain?
        Dr. Seppala. Yes, there are standards of care defined for
    the prescription of opioids for pain, for acute pain and for
    chronic pain, and there has been a shift in how that is viewed,
    and the standards have shifted over the last 10 years, first to
    increase the prescribing of opioids for chronic pain, and now
    to decrease and go back to a more conservative approach. So it
    is being understood in medicine but, you know, I am reading the
    literature right out of the pain folks who understand this, and
    the primary care docs don't necessarily follow suit for years--
    --
        Ms. Clarke. Um-hum.
        Dr. Seppala [continuing]. They still have to kind of catch
    up, so we do need to educate our physician population.
        Ms. Clarke. Dr. Lembke, I would like to get your thoughts
    on that as well.
        Dr. Lembke. Well, there is a long story to why we
    overprescribe prescription opioids, which we do, and basically,
    it started in the 1980s when there was this recognition that we
    were not doing enough to treat pain. It also coincided with the
    hospice movement. And there was a big push to use opioids more
    liberally for the treatment of pain, so doctors did that. What
    happened was that the evidence that showed the use of opioids
    was indicated for people who were dying was then turned over to
    the use of opioids in those who have chronic pain conditions.
    And Purdue Pharma and others aggressively marketed to doctors
    to use opioids for chronic pain, although there is no evidence
    to show that they are effective for chronic pain. And now
    reports are coming out that the risks far exceed any benefits
    that you might have for an individual patient. So now there has
    been a big seat change in that regard. Nonetheless, it is hard
    to get doctors to catch up with that seat change.
        Ms. Clarke. So are physicians not getting the appropriate
    level of training and education in pain management, and how to
    identify patients who may be at risk for addiction? And I don't
    know what that universe looks like. It sounds to me, just in
    hearing the dialogue, that just about everyone can be a
    candidate for addiction under that construct.
        Dr. Lembke. They are now getting that education, and there
    are standards. The problem is that a doctor gets paid twice as
    much for a 5-minute medication management visit as they do for
    1 hour talking to patients, so there is, again, no
    infrastructure to incentivize doctors to not prescribe pills.
    There is a lot of incentive for them to prescribe.
        Ms. Clarke. Dr. Harris, would the AMA support mandatory CME
    or responsible opioid prescribing practices in addiction tied
    to the DEA registration of controlled substances?
        Dr. Harris. So I think the mandatory is the issue, and I
    think the AMA would like to offer an alternative approach
    because mandatory CME just feels like sort of a one-size-fits-
    all. You have many psychiatrists here on the panel, and the
    education that we may need might be different than the
    education of our primary care colleagues, and so certainly more
    education is the key. We are right now cataloging best
    practices. Each of the specialties are looking at how should
    they educate their own colleagues. And so really it is about
    the right education at the right level, for the right
    specialty. So education is key, but certainly not mandatory.
    Feels like that is a one-size-fits-all----
        Ms. Clarke. I am over time but, Dr. Lembke, do you agree,
    should we be mandating or do you think that it should be left
    to the field to make----
        Dr. Lembke. Yes, so I respectfully disagree with Dr.
    Harris. I think that when doctors get their DEA license to
    prescribe controlled and potentially addictive medications,
    they should mandatory be taught how to use a prescription drug
    monitoring system, that that just simply should be the standard
    of care, independent of their subspecialty.
        Ms. Clarke. Mr. Chairman, I thank you for your indulgence.
    I yield back.
        Mr. Murphy. Thank you. This has been quite an enlightening
    panel. I have been writing down some of your recommendations. I
    have a number of things here. Change the 42 C.F.R. program to
    bring us up to 2015 standards of integrating physical and
    behavioral medicine so that we can know who is getting
    addiction treatments, and help the practices. Improve the intra
    and interstate communication between pharmacies and physicians
    so they can distinguish between patients who truly need a
    medication, versus those who are involved with addiction
    shopping. Better define recovery. Dr. DuPont, you had said not
    in terms of just today if they are off medication, but recovery
    as a longer term. And many of you have used the word chronic.
    And we need to be paying attention to longer-term data. We need
    more education to monitor physicians, and more education of
    monitoring for physicians so they understand prescription drug
    use here, and what treatment from pain is. We also have to make
    sure we do have insurance parity to truly deal with this
    treatment, something we have been dealing with on this
    committee for 6 or 7 years now. We need more providers who are
    trained and experienced with mental illness, severe mental
    illness, and addiction. More inpatient beds for treatment for
    detox, for in-depth treatments that meets the needs of the
    patients. And understanding that medication-assisted therapy
    and psychosocial therapy are not enough; we have to make sure
    that we have this spectrum, the pallet of treatments available
    to people to meet their needs.
        I think now as we look at that sobering number of 43,000
    overdose deaths, and 1 \1/2\ million on some of these
    medications as treatments, we have our marching orders. This is
    not something that is simple, but it is something that I think
    is doable. And the good news is this is the committee that can
    do it, so we will get our work together.
        Again, I want to thank this very distinguished panel.
    Remind members that they have a few days to get to us their--
    what is it?
        Voice. Ten business days.
        Mr. Murphy. Ten business days to submit questions for the
    record. And ask all the witnesses if you would respond promptly
    to this. Again, thank you so very much. We have our work cut
    out for us.
        This committee is adjourned.
        [Whereupon, at 1:03 p.m., the subcommittee was adjourned.]
        [Material submitted for inclusion in the record follows:]

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