[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]


 
                 EXAMINING THE GROWING PROBLEMS OF 
                 PRESCRIPTION DRUG AND HEROIN ABUSE

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             APRIL 29, 2014

                               __________

                           Serial No. 113-140
                           
                           
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


      Printed for the use of the Committee on Energy and Commerce

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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman
RALPH M. HALL, Texas                 HENRY A. WAXMAN, California
JOE BARTON, Texas                      Ranking Member
  Chairman Emeritus                  JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky                 Chairman Emeritus
JOHN SHIMKUS, Illinois               FRANK PALLONE, Jr., New Jersey
JOSEPH R. PITTS, Pennsylvania        BOBBY L. RUSH, Illinois
GREG WALDEN, Oregon                  ANNA G. ESHOO, California
LEE TERRY, Nebraska                  ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan                GENE GREEN, Texas
TIM MURPHY, Pennsylvania             DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas            LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee          MICHAEL F. DOYLE, Pennsylvania
  Vice Chairman                      JANICE D. SCHAKOWSKY, Illinois
PHIL GINGREY, Georgia                JIM MATHESON, Utah
STEVE SCALISE, Louisiana             G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio                JOHN BARROW, Georgia
CATHY McMORRIS RODGERS, Washington   DORIS O. MATSUI, California
GREGG HARPER, Mississippi            DONNA M. CHRISTENSEN, Virgin 
LEONARD LANCE, New Jersey                Islands
BILL CASSIDY, Louisiana              KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky              JOHN P. SARBANES, Maryland
PETE OLSON, Texas                    JERRY McNERNEY, California
DAVID B. McKINLEY, West Virginia     BRUCE L. BRALEY, Iowa
CORY GARDNER, Colorado               PETER WELCH, Vermont
MIKE POMPEO, Kansas                  BEN RAY LUJAN, New Mexico
ADAM KINZINGER, Illinois             PAUL TONKO, New York
H. MORGAN GRIFFITH, Virginia         JOHN A. YARMUTH, Kentucky
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina

              Subcommittee on Oversight and Investigations

                        TIM MURPHY, Pennsylvania
                                 Chairman
MICHAEL C. BURGESS, Texas            DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
MARSHA BLACKBURN, Tennessee          BRUCE L. BRALEY, Iowa
PHIL GINGREY, Georgia                BEN RAY LUJAN, New Mexico
STEVE SCALISE, Louisiana             JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi            G.K. BUTTERFIELD, North Carolina
PETE OLSON, Texas                    KATHY CASTOR, Florida
CORY GARDNER, Colorado               PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
BILL JOHNSON, Ohio                   JOHN A. YARMUTH, Kentucky
BILLY LONG, Missouri                 GENE GREEN, Texas
RENEE L. ELLMERS, North Carolina     HENRY A. WAXMAN, California (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     1
    Prepared statement...........................................     3
Hon. Diana DeGette, a Representative in Congress from the state 
  of Colorado, opening statement.................................     4
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................     6
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     7
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, prepared statement...............   101

                               Witnesses

Michael Botticelli, Acting Director, Office of National Drug 
  Control Policy, Executive Office of the President..............     9
    Prepared statement...........................................    12
    Answers to submitted questions...............................   106
Daniel M. Sosin, Acting Director, National Center for Injury 
  Prevention and Control, Centers for Disease Control and 
  Prevention.....................................................    26
    Prepared statement...........................................    28
    Answers to submitted questions...............................   126
Nora D. Volkow, Director, National Institute on Drug Abuse, 
  National Institutes of Health..................................    35
    Prepared statement...........................................    37
    Answers to submitted questions...............................   137
H. Westley Clark, Director, Center for Substance Abuse Treatment, 
  Substance Abuse and Mental Health Services Administration......    53
    Prepared statement...........................................    55
    Answers to submitted questions...............................   150
Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of 
  Diversion Control, Drug Enforcement Agency, U.S. Department of 
  Justice........................................................    65
    Prepared statement...........................................    67
    Answers to submitted questions...............................   161

                           Submitted Material

Op-ed entitled, ``Senate must pass bills to fight tragedy of drug 
  addiction,'' The Courier-Journal, April 1, 2014, submitted by 
  Mr. Yarmuth....................................................   103


  EXAMINING THE GROWING PROBLEMS OF PRESCRIPTION DRUG AND HEROIN ABUSE

                              ----------                              


                        TUESDAY, APRIL 29, 2014

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:00 a.m., in 
room 2322 of the Rayburn House Office Building, Hon. Michael 
Burgess (vice chairman of the subcommittee) presiding.
    Members present: Representatives Burgess, Blackburn, 
Gingrey, Scalise, Harper, Gardner, Griffith, Johnson, Long, 
Ellmers, DeGette, Braley, Lujan, Schakowsky, Castor, Welch, 
Yarmuth, Green and Waxman (ex officio).
    Staff present: Carl Anderson, Counsel, Oversight; Karen 
Christian, Chief Counsel, Oversight; Brittany Havens, 
Legislative Clerk; Sean Hayes, Deputy Chief Counsel, Oversight 
and Investigations; Tom Wilbur, Digital Media Advisor; Phil 
Barnett, Democratic Staff Director; Brian Cohen, Democratic 
Staff Director, Oversight and Investigations, Senior Policy 
Advisor; Kiren Gopal, Democratic Counsel; Hannah Green, 
Democratic Staff Assistant; Anne Morris Reid, Democratic Senior 
Professional Staff Member; and Stephen Salsbury, Democratic 
Investigator.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. Good morning. I now convene the hearing of the 
Subcommittee on Oversight and Investigations, entitled 
Examining the Growing Problems of Prescription Drug and Heroin 
Abuse.
    Just a brief housekeeping detail for those of you who were 
expecting to see Dr. Murphy here in the chair, he was called 
away back to his district for a family issue, so you are stuck 
with me, as the saying goes, but we will get through this 
together.
    On the issue of prescription drug and heroin abuse, these 
are separate and distinct problems, but unfortunately, they do 
share a common endpoint; addiction, abuse, overdose, and death. 
As we know, the abuse of prescription drugs, and illegal drugs 
such as heroin, have plagued our nation for decades, however, 
over the last several months, there have been increasing 
reports that prescription drug and heroin abuse in communities 
around the country continues to grow. Sadly, those reports 
indicate that overdose deaths as a result of prescription drug 
and heroin abuse are also on the rise. Families have lost sons 
and daughters, mothers and fathers to this addiction.
    Data from the federal agencies charged with addressing drug 
abuse paint a startling picture of the severity of the public 
health crisis. Prescription drug abuse kills more than 16,000 
people a year. From 2007 to 2012, heroin use rose by almost 80 
percent in this country, and 3,000 people die each year from 
heroin overdoses. The United States Attorney General, Eric 
Holder, declared recently that heroin abuse constitutes ``an 
urgent and growing public health crisis.''
    Certainly, there is a law enforcement aspect to solving 
this problem, and stopping the bad actors who illegally 
distribute prescription drugs or traffic heroin, but the other 
part of the equation is treating the addiction, the addiction 
to prescription drugs and heroin, and preventing deaths. The 
answer to a burgeoning heroin epidemic, as the Administration 
has called it, is not to wage war on all opiates. To address a 
complex issue, the solution cannot be simple.
    The purpose of today's hearing is to examine the federal 
response, including the public health response, to prescription 
drug and heroin abuse. Our oversight has revealed that this is 
a complex problem. Those who abuse drugs also have, often, an 
underlying mental illness. Treating their addiction means that 
the underlying mental illness must be successfully diagnosed 
and treated. As the testimony of Mr. Botticelli states, the 
substance abuse is a progressive disease. Those who suffer from 
addiction often start at a young age with alcohol, maybe 
marijuana, move on to other drugs like opiates. In examining 
opiate abuse, we must also consider the factors that lead 
people to abuse, and what we are doing to address those 
factors.
    Many Americans also suffer from chronic and debilitating 
pain. It is important to remember that the millions of 
individuals who safely use opiate narcotics under the guidance 
of their physicians, pain that we hope a loved one would never 
have to suffer is involved. As Dr. Volkow of NIH recognizes in 
her testimony, we need to recognize the special character of 
prescription drug abuse. On the one hand, we have a growing 
prescription drug and opiate addiction. On the other, we have a 
very real need for these drugs to treat chronic pain, treat 
acute pain, and alleviate suffering where it exists, especially 
in patients with chronic conditions who are suffering from 
illnesses like cancer. These drugs are safe when used as 
directed. It is their improper use that leads to abuse, 
overdose, and death.
    Over recent years, we have heard a great deal about doctor 
shopping, about pill mills, and about the efforts of the 
prescription drug monitoring plans to address these problems. 
We need to ensure that doctors and pharmacists have the tools 
at their disposal to adequately fill their role with ensuring 
appropriate prescribing, but addicts also get these drugs 
through illegal channels, such as rogue Internet pharmacies, 
off the street, and obtaining them through family members who 
may have an outdated prescription. Although some question 
whether federal efforts to crackdown and prevent prescription 
drug abuse have contributed to the recent rise in heroin abuse, 
and whether this should have been anticipated, there is no 
question that both are on the rise, and as a consequence, we 
have a responsibility to recognize and solve that problem. 
While most prescription drug abusers do not go on to abuse 
heroin, there is data from the White House Office of National 
Drug Control Policy, and the Substance Abuse and Mental Health 
Services Administration, that indicates over 80 percent of 
people who started using heroin in 2008 to 2010 had previously 
abused prescription drugs.
    The Federal Government is devoting resources to drug 
control programs. Some would say significant resources; over 
$25 billion annually, of which about $10 billion goes towards 
drug abuse prevention and treatment programs across 19 
different federal agencies. We will ask today's witnesses to 
identify the specific policies, the programs, the initiatives 
that have been the most effective in combatting prescription 
drug and heroin abuse, and which have not. With 19 agencies 
having a hand in over 70 drug control programs, we need to know 
what is working and what is not. What can we do better?
    Is oversight by the federal agencies also an important 
issue as significant funding is block granted to the states for 
their treatment programs?
    Testifying before us today are representatives of five of 
the agencies with lead roles in addressing opiate abuse. Mr. 
Michael Botticelli, the Acting Director of the White House 
Office of National Drug Control Policy; Mr. Daniel Sosin of the 
Centers for Disease Control and Prevention; Dr. Nora Volkow of 
the National Institute on Drug Abuse; Dr. Westley Clark of the 
Substance Abuse and Mental Health Services Administration; and 
Mr. Joseph Rannazzisi of the Drug Enforcement Agency.
    This is a prestigious panel, and we are very grateful for 
your presence here today. We certainly look forward to your 
testimony.
    [The prepared statement of Mr. Burgess follows:]

             Prepared statement of Hon. Michael C. Burgess

    Good morning. I now convene this hearing of the 
Subcommittee on Oversight and Investigations entitled 
``Examining the Growing Problems of Prescription Drug and 
Heroin Abuse.''
    These are separate and distinct problems with a common end 
point; abuse, overdose, and death.
    As we know, the abuse of prescription drugs and illegal 
drugs such as heroin have plagued our nation for decades. 
However, over the last several months, there have been 
increasing reports that prescription drug and heroin abuse in 
communities around the country continue to grow. Sadly, those 
reports indicate that overdose deaths as a result of 
prescription drug and heroin abuse are also on the rise. 
Families have lost sons and daughters and fathers and mothers 
to this addiction.
    Data from the federal agencies charged with addressing drug 
abuse paint a startling picture of the severity of this public 
health crisis. Prescription drug abuse kills more than 16,000 
people a year. From 2007 to 2012, heroin use rose by 79 percent 
in this country and 3,000 people die each year from heroin 
overdoses.
    U.S. Attorney General Eric H. Holder declared recently that 
heroin abuse constitutes ``an urgent and growing public health 
crisis.'' Certainly, there is a law enforcement aspect to 
solving this problem and stopping the bad actors who illegally 
distribute prescription drugs or traffic heroin. But the other 
part of the equation is treating addiction to prescription 
drugs and heroin--and preventing deaths. The answer to a 
burgeoning heroin epidemic, as the administration has called 
it, is not to wage a war on all opioids. To address a complex 
issue, the solution will not be simple.
    The purpose of today's hearing is to examine the federal 
response, including the public health response, to prescription 
drug and heroin abuse. Our oversight has revealed that this is 
a complex problem. Those who abuse drugs often have an 
underlying mental illness. Treating their addiction means that 
the underlying mental illness must be successfully diagnosed 
and treated.
    As the testimony of Mr. Botticelli, states, substance abuse 
is a ``progressive disease.'' Those who suffer from addiction 
often start at a young age, with alcohol and marijuana, and 
then move to other drugs like opioids. In examining opioid 
abuse, we must also consider the factors that lead people to 
abuse--and what we are doing to address them.
    Many Americans also suffer from chronic and debilitating 
pain. It is important to remember the millions of individuals 
who safely use opioids under the guidance of their physicians, 
pain that we all hope us or a loved one would never suffer.
    As Dr. Volkow of NIH recognizes in her testimony, we need 
to recognize the ``special character'' of prescription drug 
abuse. On one hand, we have growing prescription drug and 
opiate addiction; on the other, we have the very real need for 
these drugs to treat chronic pain and alleviate suffering, 
especially in patients with conditions like cancer. These drugs 
are safe when used as directed--it is their improper use that 
leads to abuse and overdose.
    Over recent years, we have heard a great deal about doctor 
shopping, pill mills, and the efforts of Prescription Drug 
Monitoring Plans to address these problems. We need to ensure 
that doctors and pharmacists have the tools at their disposal 
to adequately fill their role in ensuring appropriate 
prescribing. But addicts also get these drugs through illegal 
channels, such as rogue Internet pharmacies, off the street, 
and obtaining them through family and friends. Although some 
question whether federal efforts to crackdown or prevent 
prescription drug abuse have contributed to the recent rise in 
heroin abuse, and whether this should have been anticipated, 
there is no question that both are on the rise and we have a 
responsibility to examine this issue fully.
    While most prescription drug abusers do not go on to abuse 
heroin, there is data from the White House Office of National 
Drug Control Policy (ONDCP) and the Substance Abuse and Mental 
Health Services Administration (SAMHSA) that indicates 81 
percent of people who started using heroin in 2008 to 2010 had 
previously abused prescription drugs.
    The federal government is devoting significant resources to 
drug control programs -over $25 billion annually, of which 
about $10 billion goes toward drug abuse prevention and 
treatment programs across 19 federal agencies. We will ask 
today's witnesses to identify the specific policies, programs, 
and initiatives have been most effective in combatting 
prescription drug and heroin abuse--and which have not. With 19 
agencies having a hand in over 70 drug control programs--is 
this working? What can we do better? Oversight by the federal 
agencies is also an important issue, as significant funding is 
block granted to states for treatment programs
    Testifying before us today are representatives of the five 
agencies with lead roles in addressing opiate abuse: Mr. 
Michael Botticelli, Acting Director of the White House Office 
of National Drug Control Policy; Dr. Daniel Sosin of the 
Centers for Disease Control and Prevention; Dr. Nora Volkow of 
the National Institute on Drug Abuse; Dr. H. Westley Clark of 
the Substance Abuse and Mental Health Services Administration 
(SAMHSA); and Mr. Joseph Rannazzisi of the Drug Enforcement 
Agency. This is a prestigious panel, and I thank you for being 
here today. We look forward to your testimony.

    Mr. Burgess. I would now like to recognize for 5 minutes 
for the purposes of an opening statement the ranking member, 
Ms. DeGette from Colorado.

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

    Ms. DeGette. Thank you so much, Mr. Burgess, and we are 
glad to have you presiding today.
    Prescription drug and heroin abuse is a public health 
crisis and it is growing every day. In many communities across 
the country, we are seeing an epidemic of opioid overdose 
deaths. I am interested in learning from the panel about what 
more we can do to prevent the abuse of these drugs, and also to 
save lives.
    The non-medical use of opioids has escalated in recent 
years. In 2011, hospitals tallied nearly \1/2\ million 
emergency room visits related to these medications. The number 
of these visits nearly tripled over a 7-year period. The link 
between prescription opioid use and heroin abuse is also deeply 
troubling, and as the Chairman noted, only a small percentage 
of people who use pain relievers go on to abuse heroin, but the 
opposite is not true. The vast majority of those who abuse 
heroin previously abused prescription drugs.
    While far more people continue to abuse prescription drugs, 
the number of individuals who reported heroin nearly doubled 
between 2007 and 2012. There is also evidence to suggest that 
people who abuse prescription drugs move on to heroin as pain 
relievers become less available or too costly. A 2012 study in 
the New England Journal of Medicine found heroin use rose 
dramatically after the introduction of an abuse deterrent form 
of Oxycontin.
    The use of drugs that ultimately lead to addiction and 
abuse often begins innocently. The majority of people who 
illegally use a prescription drug get that drug from a friend 
or a family member often, and sometimes the drug has been 
stolen, but at other times, a parent may even give the drug to 
a child, unaware of the risks. We must educate patients on the 
dangers of abuse of these drugs, as well as the need to 
properly store and dispose of them. If we can reduce 
inappropriate access to drugs, we can also reduce the incidence 
of their abuse. We must change the public perception of the 
prescription opioids. We face the inaccurate perception that 
just because a drug is legal, it is somehow less harmless, less 
addictive and less risky. Providers should also be better 
educated on the use and potential abuse of these drugs, so they 
can be more effective in recognizing problems of abuse, and, in 
turn, more effective in educating and treating the patients. 
Studies show that even brief interventions by healthcare 
providers can be successful in reducing or eliminating 
substance abuse by patients who began abusing prescription 
opioids but have not yet become addicted to them.
    When prescribed appropriately, these medicines provide 
much-needed relief, and many patients have had their suffering 
reduced by opioid pain killers. However, a patient with an 
acute short-term pain may be able to find relief from a less 
addictive pain killer. Prescription drug abuse is a public 
health problem, and it is not just a law enforcement problem. 
Reducing this abuse will require a multifaceted approach, and 
partnership among federal, state and local agencies. Every 
state should effectively use prescription drug monitoring 
programs. These databases help states identify and address drug 
diversion, so they should be as robust and effective as 
possible. States should be able to share information with due 
regard for privacy expectations. Information should be added to 
the databases regularly, including by encouraging prescribers 
and pharmacists to use the databases. When used, they can help 
doctors and public health authorities prevent and respond to 
the potential devastating effects of prescription drug abuse.
    I am interested in learning from our witnesses today about 
the effects of this medication assisted treatment that we are 
hearing about, and also whether we have the resources to meet 
the demand for these treatment programs. I am also interested 
in learning about the state of research into new medications 
with lower abuse potential, and how we can expand access to 
overdose interventions like naloxone.
    Prescription opioid and heroin abuse, as you said, Mr. 
Chairman, is a serious public health threat. I look forward to 
hearing from all of the witnesses, and to working with all of 
my colleagues on both sides of the aisle to ensure that 
Congress plays a vital role in protecting families from the 
growing danger of these drugs.
    And I yield back the balance of my time.
    Mr. Burgess. The gentlelady yields back.
    The Chair now recognizes the gentlelady from Tennessee 5 
minutes for purposes of an opening statement please.

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

    Mrs. Blackburn. Thank you, Mr. Chairman. And I know we are 
all cheering for Congressman Murphy and his daughter, as they 
are about to welcome that new baby into their family. What an 
exciting, exciting time. I can only tell you the joys of being 
a grandparent are marvelous. It is a big part of my day.
    Well, I thank you for the attention that we are putting on 
this issue. Prescription drug and heroin abuse are epidemic in 
our country, and I think you can tell by what is being said in 
this room this morning; it is an issue that our committee is 
concerned about, and I applaud the efforts of the committee to 
take a very thoughtful approach and process as how we move 
forward. It is clear that we need to understand the factors 
that have contributed to the rise in prescription drug and 
heroin abuse. We need to understand which prevention, 
treatment, and law enforcement efforts are the most effective 
in reducing the abuse of prescription drugs and heroin.
    On the other side of this issue are the millions of 
Americans who have legitimate need for prescription medication 
for the control of pain, reduction of anxiety, and the overall 
improvement of their lives. These medications must be available 
to them. H.R.4069, the Ensuring Patient Access and Effective 
Drug Enforcement Act of 2013, that is a Bill by Representative 
Marino and I, it will establish a combatting prescription drug 
abuse working group. This group will include members from the 
DEA, FDA, ONDCP, State Attorney Generals, patient groups, 
pharmacists, industry, healthcare providers and others. Within 
one year of enactment, the working group shall provide, they 
must do this, provide recommendations to Congress on 
initiatives to reduce prescription drug diversion and abuse. We 
think this is the right approach.
    We welcome each of our witnesses. We look forward to 
hearing your testimony and to the discussion.
    And with that, Mr. Chairman, I yield back my time, or to 
anyone who is seeking time.
    Mr. Burgess. Seeing no one seeking time, the gentlelady 
yields back.
    The Chair now recognizes the ranking member of the full 
committee, Mr. Waxman, 5 minutes for an opening statement 
please.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you, Mr. Chairman, for holding this 
important hearing today.
    We are here to discuss the epidemic of opioid abuse. The 
numbers are stark. Each year, approximately 17,000 people die 
from prescription opioid overdoses, and 3,000 die from heroin 
overdoses.
    For far too long, prescription opiate pain relievers were 
prescribed too easily, without enough attention paid to the 
potential risks, and a large number of people became addicted. 
Some of those who became addicted to prescription opiates 
eventually moved on to heroin because that is a cheaper 
alternative, offering the same high.
    Fortunately, there are steps that we can take to fight this 
problem. I appreciate our witnesses being here today to discuss 
their efforts to educate the public and providers about the 
dangers of abusing these drugs. We will also hear how we can 
change prescribing practices, monitor the use of opiates, 
effectively treat those who are addicted, and investigate and 
prosecute those involved in diverting and trafficking these 
drugs.
    Our five witnesses, Mr. Rannazzisi from the DEA; Mr. 
Botticelli from ONDCP; Dr. Sosin from CDC; Dr. Volkow from NIH; 
and Dr. Clark from SAMHSA, represent an all-star panel of 
experts, and we are delighted that you are here.
    There are many reasons to be thankful for the launch of the 
Affordable Care Act. Let me repeat that. There are many reasons 
to be thankful for the launch of the Affordable Care Act. One 
that is often overlooked is the help the law offers to 
individuals addicted to prescription opiates and heroin. The 
lack of insurance and the high cost of treatment could present 
an insurmountable barrier to receiving the help they need. The 
Affordable Care Act addresses this problem by expanding 
insurance coverage, and requiring all policies to cover the 
costs of substance abuse services. This will mean that millions 
of individuals with addiction disorders will have access to the 
tools they need to help break their addictions. We need to 
build upon this hopeful step, and increase our efforts to 
combat this epidemic.
    Mr. Chairman, at this point, I wish to yield the balance of 
my time to Mr. Welch from Vermont.
    Mr. Welch. I thank the member from California for yielding, 
and I thank the committee for having this hearing, but I want 
to give some credit to Governor Peter Shumlin of Vermont. He 
did something extremely unusual. He dedicated his entire State 
of the State Address to this single problem, and that was a 
bold decision for two reasons. One, most of the time, the State 
of the State is a laundry list of objectives and hopes. This 
got very specific about one topic. But second, in taking this 
on, he made public what people knew was real, but didn't want 
to acknowledge. And what we have seen in Vermont as a result of 
that was that we are facing what is a terrible problem that 
creates enormous anxiety for the folks that are in the grip of 
this addiction, but their families. And before we began talking 
about this, it was restricted to our law enforcement folks and 
our mental health folks who were dealing with these isolated 
individuals as though they were the only ones in the world that 
faced this incredible challenge. And what Governor Shumlin did 
is he brought it out in the open, and that was in large part 
because in his travels around, and governors do get around, he 
was talking to our law enforcement people, like Chief Taylor in 
Saint Albans, like Chief Baker in Rutland, and they were 
dealing on the street with kids that they knew and with adults 
that they knew who had jobs, but had this horrible addiction, 
and they had to deal with it. And what our police kept saying, 
who have frontline responsibilities, you cannot arrest your way 
out of this. And there is a distinction that they make between 
the dealers who came from out of state and started inflicting 
our kids and others with this opiate addiction, throw the book 
at them, forget about them, but a lot of the kids who are in 
the grip, they are our kids, they have a future, they have a 
challenge. And what has happened in our communities with the 
leadership of our police and our mental health people and our 
mayors, like Liz Gamache in Saint Albans, and like Chris Louras 
in Rutland, is that by bringing this out into the open, it has 
helped us talk about this in concrete ways so that there is not 
only the treatment program, the Hub and Spoke Program, which I 
hope you might talk about, but it also is allowing parents and 
the community to see this as something where we all have to be 
engaged to provide some basis of support for these kids and 
adults who want not to be in the grip of this horrible opiate 
addiction.
    So I thank you, the committee, for having this hearing, and 
making it a collective effort to try to bring our resources 
together to help people get whole. Thank you.
    Mr. Burgess. The gentleman yields back.
    I would now like to introduce the witnesses on the panel 
for today's hearing. Mr. Michael Botticelli is the Acting 
Director of the Office of National Drug Control Policy in the 
Executive Office of the President; Dr. Daniel Sosin, who is the 
Acting Director of the National Center for Injury Prevention 
and Control at the Centers for Disease Prevention; Dr. Nora 
Volkow is the Director of the National Institute on Drug Abuse 
at the National Institute of Health; Dr. Westley Clark is the 
Director of the Center for Substance Abuse Treatment within the 
Substance Abuse and Mental Health Services Administration; and 
Mr. Joseph Rannazzisi is the Deputy Assistant Administrator in 
the Office of Diversion Control within the Drug Enforcement 
Agency at the United States Department of Justice.
    I will now swear in the witnesses. As you are aware, this 
committee is holding an investigative hearing, and when doing 
so, has had the practice of taking testimony under oath. Do any 
of you have any objections to testifying under oath this 
morning? Seeing a negative response from the witnesses, the 
Chair then advises that under the rules of the House and the 
rules of the committee, you are entitled to be advised by 
counsel. Do any of our witnesses desire to be advised by 
counsel during testimony today? And negative response was 
received from the panel of witnesses. In that case, if you 
would please rise and raise your right hand, I will swear you 
in.
    [Witnesses sworn.]
    Mr. Burgess. Let it be noted that the witnesses answered 
affirmatively. You are now under oath and subject to the 
penalties set forth in Title XVIII, Section 1001 of the United 
States Code.
    We would now welcome a 5-minute summary of your written 
statements. We will start with Mr. Botticelli and move down the 
table.

 STATEMENTS OF MICHAEL BOTTICELLI, ACTING DIRECTOR, OFFICE OF 
     NATIONAL DRUG CONTROL POLICY, EXECUTIVE OFFICE OF THE 
 PRESIDENT; DANIEL M. SOSIN, ACTING DIRECTOR, NATIONAL CENTER 
FOR INJURY PREVENTION AND CONTROL, CENTERS FOR DISEASE CONTROL 
AND PREVENTION; NORA D. VOLKOW, DIRECTOR, NATIONAL INSTITUTE ON 
 DRUG ABUSE, NATIONAL INSTITUTES OF HEALTH; H. WESTLEY CLARK, 
DIRECTOR, CENTER FOR SUBSTANCE ABUSE TREATMENT, SUBSTANCE ABUSE 
   AND MENTAL HEALTH SERVICES ADMINISTRATION; AND JOSEPH T. 
RANNAZZISI, DEPUTY ASSISTANT ADMINISTRATOR, OFFICE OF DIVERSION 
  CONTROL, DRUG ENFORCEMENT AGENCY, U.S. DEPARTMENT OF JUSTICE

                STATEMENT OF MICHAEL BOTTICELLI

    Mr. Botticelli. Chairman Burgess, Ranking Member DeGette, 
and members of the subcommittee, I want to thank you for the 
opportunity to appear today to discuss the tremendous public 
health and safety issues surrounding the diversion and abuse of 
opioid drugs, including many prescription pain killers and 
heroin, in the United States.
    I know that, given recent media attention to overdose 
deaths, there is a heightened public interest in the threat of 
opioid drug use, but this is something many communities have 
been dealing with for a very long time, and it is a matter of 
great concern for this Administration.
    According to the Centers for Disease Control and 
Prevention, drug overdose deaths, primarily driven by 
prescription opioids, now surpass homicides and traffic crashes 
in the number of injury deaths in America. In 2010, the latest 
year for which nationwide data are available, approximately 100 
Americans died on average from overdose every day. Prescription 
analgesics were involved in almost 17,000 of those deaths that 
year, and heroin was involved in about 3,000, and more recent 
data posted by several states indicates that deaths from heroin 
continued to increase.
    While heroin use remains relatively low in the United 
States as compared to other drugs, there has been a troubling 
increase in the number of people using heroin in recent years, 
from 373,000 past-year users in 2007 to 669,000 in 2012.
    It is clear that we cannot arrest our way out of the drug 
problem. Science has shown us that drug addiction is a disease 
of the brain, a disease that can be prevented, treated, and 
from which one can recover. We know that substance use 
disorders, including those driven by opioids, are a progressive 
disease. Many people who develop a substance use disorder begin 
using at a young age, and often start with alcohol, tobacco 
and/or marijuana. We know that as an individual's abuse of 
prescription opioids becomes more frequent or chronic, that 
person is more inclined to purchase the drugs from dealers or 
obtain prescriptions from multiple doctors, rather than simply 
getting it from a friend or relative for free or without 
asking. This progression of an opioid use disorder may lead an 
individual to pursue a lower cost alternative such as heroin.
    With these circumstances in mind, we released the Obama 
Administration's inaugural National Drug Control Strategy in 
2010, in which we set out a wide array of actions to expand 
public health interventions and criminal justice reforms to 
reduce drug use and its consequences in the United States. That 
strategy noted opioid overdoses as a growing national crisis, 
and set specific goals for reducing drug use, including heroin.
    Three years ago, the Administration released the first 
comprehensive action plan to combat the prescription drug abuse 
epidemic. The Prescription Drug Abuse Prevention Plan strikes a 
balance between the need to prevent diversion and abuse, and 
the need to ensure legitimate access to prescription pain 
medications. The Plan expands on the National Drug Control 
Strategy, and brings together a variety of Federal, state, 
local, and tribal partners to support: 1) the expansion of 
state-based prescription drug monitoring programs; 2) more 
convenient and environmentally responsible disposal methods for 
removing expired or unneeded medication from the home; 3) 
education for patients and training of healthcare providers in 
the proper prescribing practices and treatment of substance use 
disorders; and 4) reducing the prevalence of pill mills and 
doctor shopping through enforcement efforts. This work has been 
paralleled by efforts to address heroin trafficking and use.
    The Administration is also focusing on several keys areas 
to reduce and prevent opioid overdoses, including educating the 
public about overdose risks and interventions, increasing 
access to naloxone, an emergency overdose reversal medication, 
and working with states to promote Good Samaritan laws and 
other measures that can help save lives. Because police are 
often the first on scene of an overdose, the Administration 
strongly encourages local law enforcement agencies to train and 
equip their personnel with this lifesaving drug.
    It is not enough, however, to save a life from an overdose. 
A smart public health approach requires us to catch the signs 
and symptoms of substance use early, before it develops into a 
chronic disorder. We have been encouraging the use of screening 
and brief intervention to catch risky substance use before it 
becomes an addiction, and since only 11 percent of those who 
needed substance use disorder treatment in 2012 actually 
received it, the Administration is dramatically expanding 
access to treatment. The Affordable Care Act and Federal parity 
law are extending access to substance use disorders and mental 
health benefits for an estimated 62 million Americans, helping 
to close the treatment gap and integrate substance use 
treatment into mainstream healthcare. This represents the 
largest expansion of treatment access in a generation and can 
help guide millions into successful recovery.
    The standard of care for treating substance use disorders 
driven by heroin or prescription opioids involves the use of 
medication-assisted treatment, an approach to treating opioid 
addiction that utilizes behavioral therapy along with FDA-
approved medications, either methadone, buprenorphine, or 
naltrexone. Mediation-assisted treatment has already helped 
thousands of people in long-term recovery, and I applaud the 
recent commentary by my HHS colleagues in the New England 
Journal of Medicine to expand the use of medications to treat 
opioid addiction and reduce overdose deaths.
    There are some signs that our national efforts are working. 
The number of Americans 12 and older initiating the non-medical 
use of prescription opioids in the past year has decreased 
significantly since 2009. Additionally, according to the latest 
Monitoring the Future survey, the rate of past year use of 
Oxycontin or Vicodin among high school seniors in 2013 is at 
its lowest since 2002. And recent studies have shown that 
implementation of robust naloxone distribution programs and the 
expansion of medication-assisted treatment can reduce mortality 
and also be cost-effective.
    However, continuing challenges with prescription opioids 
and the re-emergence of heroin use underscore the need for 
leadership at all levels of government. We will therefore 
continue to work with our Federal, state, tribal and community 
partners to continue to reduce and prevent the health and 
safety consequences of prescription opioids and heroin. Thank 
you for the opportunity to address the committee today.
    [The prepared statement of Mr. Botticelli follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Mr. Burgess. The gentleman yields back.
    The Chair recognizes Dr. Sosin for the purposes of the 5-
minute opening statement please.

                  STATEMENT OF DANIEL M. SOSIN

    Dr. Sosin. Good morning, Chairman Burgess, and members of 
the subcommittee. Thank you for the opportunity to testify 
about the public health issues related to prescription drug 
overdoses, and the Centers for Disease Control and Prevention's 
role in preventing them.
    It is an honor to be with you today to talk about CDC's 
approach to prescription drug overdoses and the prevention of 
them.
    Drug overdose death rates are higher than they have ever 
been, with prescription opioids being a key driver of this 
trend. More than 125,000 Americans have died from prescription 
opioid overdoses in the last decade. CDC has played an 
important role in raising the visibility of the health impact 
of prescription opioid overdoses, and helping to identify the 
role of increased inappropriate opioid prescribing in fueling 
this epidemic. Research also suggests that the growth in heroin 
use may be due in part to the increased addiction caused by the 
rise in prescribing of opioid pain relievers.
    The doubling in heroin use in the past 6 years is a 
worrisome trend, and undoubtedly has a relationship to 
prescription opioids. Reducing inappropriate opioid prescribing 
is one of the approaches needed to keep people from becoming 
addicted to opioids, and prevent them from later transitioning 
to heroin.
    Because of the complexity of these issues, the response 
demands engagement from a diverse group of federal, state and 
local partners. The partners at this table are all critical in 
the overall goal to reduce abuse and overdose of opioids while 
ensuring that patients with pain are safely and effectively 
treated.
    As the nation's health protection agency, CDC is focused on 
upstream drivers of this epidemic, in this instance, the 
prescribing behaviors that created and continue to fuel this 
crisis. Our approach fits into three pillars that leverage 
CDC's unique expertise: One, improving data quality and use to 
monitor the trends and causes of the epidemic. Timely, drug-
specific information on prescribing, and the health effects of 
prescription drugs is critical. We generate, use, and improve 
data to identify threats, assess local trends, and evaluate the 
impact of prevention measures. Two, strengthening state 
prevention efforts. States maintain prescription drug 
monitoring programs, or PDMPs. States regulate healthcare 
professionals and institutions, they monitor the problem 
through their health departments, and they run large public 
insurance programs, including Medicaid. CDC provides resources 
and technical assistance to states to implement interventions 
and evaluate and adapt their approach to have the most impact. 
And three, improving patient safety by supporting healthcare 
providers and systems with tools and data needed to respond 
effectively. For example, CDC is working to promote responsible 
opioid prescribing through guidelines and decision support 
tools.
    While CDC has ongoing work in each of these areas, we are 
focusing this year on accelerating state prevention efforts. We 
will be funding four to five state health departments for up to 
a total of $2 million per year to implement and evaluate the 
strategies I just outlined.
    The 2015 President's Budget includes a request for $15.6 
million in new funds to expand CDC's Core Violence and Injury 
Prevention Program, which is a state-based program addressing 
injury and violence prevention. This will allow us to include 
additional states with the high burden of prescription drug 
overdose, to prevent injuries and violence, and expand the 
investment of these programs on reducing prescription drug 
overdose.
    In conclusion, prescription drug abuse and overdose is a 
serious public health problem in the United States. The burden 
of prescription drug abuse and overdose affects people of all 
walks of life, and many sectors of our economy. Addressing this 
complex problem requires a multifaceted approach and 
collaboration. CDC is committed to tracking and understanding 
the epidemic, supporting states working on the frontlines of 
this crisis, and rigorously evaluating what works to improve 
patient safety, prevent overdoses and save lives.
    Thank you again for the opportunity to be here today.
    [The prepared statement of Dr. Sosin follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
        
    Mr. Burgess. Thank you. The gentleman yields back.
    The Chair recognizes Dr. Volkow for 5 minutes for an 
opening statement. Thank you.

                  STATEMENT OF NORA D. VOLKOW

    Dr. Volkow [continuing]. Is a component of the NIH to speak 
about the value of science in helping address the problem from 
the diversion and abuse of prescription opioid pain killers, 
and the related rising abuse of heroin. Opioids medications are 
the most effective intervention we currently have for 
management of severe pain. Unfortunately, these drugs not only 
inhibit pain censors in the brain, but they also potently 
activate brain reward regions, which is why they are abused and 
they can cause addiction.
    So we face the unique challenge of preventing their abuse, 
while safeguarding their value for managing severe pain, which, 
if untreated, is terribly debilitating.
    It is estimated that 2.1 million Americans are addicted to 
opioid pain killers, which reflects, in part, the widespread 
availability of these drugs. Indeed, the number of yearly 
prescriptions for opioids has more than doubled over the past 
20 years, from 76 million to 207 million prescriptions per 
year, during a period that in parallel saw a fourfold increase 
in death overdoses from prescription opioids.
    Pain killers, like Oxycontin and Vicodin, affect the brain 
similarly to heroin. They interact with exactly the same opioid 
receptors. Their difference depends on the potency, that is, 
how strongly they activate those receptors, and how rapidly 
they do so. So as for heroin, they can produce euphoria, which 
some abusers of prescription medications intensify by taking 
higher doses, crushing the pills so that they can snort them or 
inject them, or taking them in combination with other drugs 
like alcohol and Benzodiazepines. These practices make opioids 
far more dangerous, not only because they are more addictive, 
but also because they increase the risk for respiratory 
depression, which is the main cause of death from overdoses.
    Recent trends, as the other witnesses have mentioned, also 
indicate a rise in heroin abuse which currently affects more 
than \1/2\ million Americans, and this rise is possibly driven 
in part by people switching from prescription opioids to heroin 
because it is cheaper and, in some instances, more available.
    Heroin is dangerous not just because of its high 
addictiveness and the overdose risk that it poses, but also 
because it is frequently injected which increases the risk of 
diseases like HIV and Hepatitis C, predominantly from the use 
of contaminated injection material.
    So what is NIDA doing about the problem? We are funding 
research in two major areas. One, research that will allow us 
to manage pain more effectively, research that will allow us to 
prevent deaths from overdoses from opioids, and that research 
will allow us to treat substance use disorders more 
effectively, including prescription medications.
    As it relates to the safe management of pain, we still 
don't know enough about the risk for addiction among chronic 
pain patients, or about how pain mechanisms in the brain 
interact with prescription opioids to influence their addictive 
potential, but ongoing research will help us clarify some of 
these issues.
    So with respect to treatment, we are funding research to 
develop non-opioid-based analgesics that are non-addictive, 
opioid medications that have less risk for diversion and abuse, 
as given by different formulations, or different ways of 
administering them, and finally, non-medication strategies such 
as transcranium magnetic stimulation, or electrical brain 
stimulation for the management of pain.
    Research related to preventing overdoses, making the 
effective opioid overdose antidote, naloxone, which is also 
very safe, more available, will help prevent many deaths. The 
FDA recently approved a handheld auto injector of naloxone that 
patients and others can use easily. NIDA is supporting the 
development of user-friendly naloxones in the form of nasal 
spray to be used by non-medical personnel or the overdose 
victim. Also, since many overdoses occur when no one is around 
or during sleep, NIDA is supporting the development of self-
activated systems that initiate an emergency response when 
wireless sensors signal that an overdose is occurring.
    As it relates to opioid addiction, methadone, buprenorphine 
and naltrexone have been shown to be effective in treating 
opioid addiction, and in preventing overdoses, but these 
medications are not being used widely. NIDA is working to 
overcome the barriers that interfere with their adoption. In 
parallel, research of new interventions such as vaccines for 
heroin will allow us to treat this problem in a different way 
and to prevent it. Additionally, we work with our partners, 
CDC, SAMHSA, ONDCP and ONC in implementing and evaluating 
evidence-based interventions.
    Again, I want to thank you for recognizing the urgency of 
the problem posed by the abuse of prescription opioids, and for 
inviting NIDA to discuss how science can help address this 
problem.
    [The prepared statement of Dr. Volkow follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]        
    
    Mr. Burgess. The Chair thanks the doctor. The gentlelady 
yields back.
    Chair recognizes Dr. Clark 5 minutes for the purposes of 
summary of your opening statement please. Your microphone, sir.

                 STATEMENT OF H. WESTLEY CLARK

    Dr. Clark. Thank you for inviting the Substance Abuse and 
Mental Health Services Administration to participate in this 
panel.
    I echo the testimony of my colleagues regarding the 
importance of the topics of this hearing. I will focus on 
SAMHSA's programs and activities, but I want to point out that 
we work with our federal partners: with states, tribes and 
local communities. According to the National Survey on Drug Use 
and Health, which SAMHSA conducts, 4.9 million people reported 
non-medical use of pain relievers during the past month in 
2012, 335,000 reported past month use of heroin, a figure that 
has more than doubled in 6 years. In 2012, more than 1.89 
million people reported initiating non-medical use of pain 
relievers, and 156,000 reported initiating use of heroin. One 
challenge in combating the misuse of pain relievers is 
educating the public on dangers of sharing medications.
    According to our national survey, 54 percent of those who 
obtained pain relievers for non-medical use in the past year 
received them from a friend or relative for free. Another 14.9 
percent either bought them or took them from a friend or 
relative. Thus, we have both the public health problem 
intertwined with a cultural problem.
    SAMHSA has several programs focused on educating the 
public, including the ``Not Worth the Risk Even If It's Legal'' 
campaign, which encourages parents to talk to their teens about 
preventing prescription drug abuse, our ``Prevention of 
Prescription Abuse in the Workplace'' effort supports programs 
for employers, employees, and their families. Our Partnership 
for Success grant includes prescription drug abuse prevention, 
as one of the capacity building activities in communities of 
high need. Our Screening, Brief Intervention and Referral to 
Treatment Program includes screening for illicit drugs, 
including heroin and other opioids. We have developed programs 
to help physicians maintain a balance between providing 
appropriate pain management, and minimizing the risk of pain 
medication misuse. Our expert medical residency program 
includes a module for prescription opioids for pain management 
and opioid misuse. Over 6,000 medical residents and over 13,700 
non-residents have been trained nationally. Our physician 
clinical support system for Medication Assisted Treatment 
training is available via live in-person, live Online, and 
recorded modules, accessible at any time. SAMHSA funds a 
Prescribers' Clinical Support System for Opioid Therapies, a 
collaborative project led by the American Academy of Addiction 
Psychiatry, with six other leading medical societies. We will 
be funding a Providers' Clinical Support System on the 
Appropriate Use of Opioids in the Treatment of Pain and Opioid-
related Addiction this fiscal year.
    Last week's article in the New England Journal of Medicine, 
authored by HHS leadership, including Dr. Volkow and SAMHSA's 
administrator, describes the underutilization of vital 
medications and addiction treatment services, and discusses 
ongoing efforts by major public health agencies to encourage 
their use.
    Medication-assisted treatment includes three strategies: 
agonist therapy, which includes Methadone maintenance; partial 
agonist therapy, which includes buprenorphine; and antagonist 
therapy, which uses an extended release injectable naltrexone, 
or Vivitrol.
    SAMHSA is responsible for overseeing the regulatory 
compliance of certified Opioid Treatment Programs which use 
methadone and/or buprenorphine for treatment of opioid 
addiction. We estimate that there are approximately 300,000 
people receiving methadone maintenance. There are currently 
26,000 physicians with a waiver to prescribe buprenorphine; of 
these, 7,700 are authorized to prescribe up to 100 patients. We 
estimate that there are 1.2 million people receiving 
buprenorphine.
    SAMHSA also issued an advisory encouraging drug courts to 
utilize Vivitrol in their treatment programs. In August of 
2013, we published the Opioid Overdose Tool Kit to educate 
families, first responders, individuals, prescribing providers, 
and community members about steps to take to prevent and treat 
opioid overdose, including the use of naloxone. When 
administered quickly and effectively, naloxone restores 
breathing to a victim in the throes of an opioid overdose. This 
can be used as a teachable moment to assess treatment need and 
refer the person to the appropriate resources. We inform states 
and jurisdictions that the Substance Abuse Prevention and 
Treatment Block Grant primary prevention set-aside funds may be 
utilized to support overdose prevention education and training. 
In addition, we notified jurisdictions that block grants, other 
than the primary prevention set-aside funds, may be used to 
purchase naloxone and the necessary materials to assemble 
overdose kits to cover the costs associated with the 
dissemination of such kits.
    SAMHSA continues to focus on our mission of reducing the 
impact of substance abuse and mental illness on America's 
communities, and we thank the subcommittee chairman and members 
for convening this important hearing, and providing SAMHSA with 
the opportunity to address this very critical issue.
    [The prepared statement of Dr. Clark follows:]
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    Mr. Burgess. The gentleman yields back.
    The Chair now recognizes Mr. Rannazzisi 5 minutes for the 
purposes of summarizing your testimony please, sir.

               STATEMENT OF JOSEPH T. RANNAZZISI

    Mr. Rannazzisi. Thank you, Chairman Burgess, and 
distinguished members of the subcommittee. On behalf of 
DEAAdministrator, Michele Leonhart, and the men and women of 
the Drug Enforcement Administration, I want to thank you for 
the opportunity to discuss today the relationship between 
prescription opioids and heroin, and how DEA is addressing the 
public health problem.
    First, let me say that the present state of affairs is not 
a surprise. DEA has been concerned about the connection between 
the rising prescription opioid diversion and abuse problem, and 
rising heroin trafficking use for several years. The DEA 
believes that increased heroin use is driven by many factors, 
including the increase and the misuse and abuse of prescription 
opioids. The signs have been there for some time now.
    Law enforcement agencies across the country have been 
reporting an increase in heroin use by teens and young adults 
who began their cycle of abuse with prescription opioids. 
Treatment providers report that opioid addicted individuals 
switch between prescription opioids and heroin, depending on 
price and availability. Non-medical prescription opioid use, 
particularly by teens and young adults, can easily lead to 
heroin use. Heroin traffickers know all this, and are 
relocating to areas where prescription drug abuse is on the 
rise.
    To give you an example, we know that many teens and young 
adults first get their prescription opioids for free, from 
medicine cabinets or friends. Let us assume that a teenager 
gets hydrocodone, a Schedule III prescription opioid, and also 
the most prescribed drug in the United States, from a family 
medicine cabinet or friend. Once that free source runs out, it 
could cost as little as between $5 and $7 a tablet on the 
street, but then the teen will eventually need more opioid to 
get the same effect that he is trying to achieve. Black market 
sales for prescription drugs are typically 5 to 10 times their 
retail value. On the street, a Schedule II prescription opioid 
can cost anywhere from $40 to $80 per tablet, depending on the 
relative strength of the drug. These increasing costs make it 
difficult to continue purchasing, especially for teens and 
young adults who don't have steady sources of income. Given the 
high cost to maintain this high, the teenager turns to heroin 
at a street cost of generally $10 a bag. The teenager gets a 
high similar to the one he got when he abused prescription 
drugs. It is just that easy.
    Any long-term solution to reduce opioid abuse must include 
actions to address prescription drug diversion and misuse, 
while also educating the public about the dangers of non-
medical use of pharmaceuticals, educating prescribers and 
pharmacists and treating those individuals who have moved from 
misuse and abuse to addiction.
    The DEA currently operates 66 tactical diversion squads in 
41 states, the District of Columbia and the Caribbean. These 
groups capitalize on combined law enforcement authorities of 
task force officers and DEA agents to conduct criminal 
investigations in the diversion of pharmaceutical drugs. The 
DEA regulates more than 1.5 million registrants. DEA diversion 
groups concentrate on the regulatory aspects of enforcing the 
Controlled Substances Act, utilizing increased compliance 
inspections. This oversight enables DEA to proactively educate 
registrants, and ensure that DEA registrants understand and 
comply with the law.
    The tactical diversion squads and the diversion groups have 
brought their skills to bear on what was previously known as 
ground zero for prescription drug use, Florida-based Internet 
pharmacies and pain clinics. As the current pill mill threat is 
driven out of Florida and moves north and northwest, DEA will 
continue to target the threat with the tactical diversion 
groups' proven law enforcement skills, the diversion groups' 
regulatory expertise, and by educating registrants.
    DEA and our law enforcement partners have aggressively 
targeted both prescription drug diversion and heroin 
trafficking. From 2001 to 2012, there has been a staggering 
increase in drug analysis of opioid pain medications, 275 
percent for oxycodone, 197 percent for hydrocodone, and 334 
percent for morphine. There has also been a significant 
increase in heroin cases. From 2008 to 2012, there was a 35 
percent increase. If the data for the first half of 2013 
remains constant, the increase from 2008 to 2013 would be 
approximately 51 percent.
    The increase in heroin abuse and trafficking is a symptom 
of our country's appetite for prescription opioids that will 
eventually lead to abuse and addiction. It is a natural 
progression from the abuse of prescription opioids.
    There is a dangerous misperception that abusing 
prescription drugs is safer than abusing heroin. Both abuse of 
prescription opioids and heroin can lead to addiction and 
death. Preventing the availability of pharmaceutical controlled 
substances to non-medical users, and educating practitioners, 
pharmacists, and the public about pharmaceutical diversion, 
trafficking and abuse are priorities at DEA. As such, DEA will 
continue to work in a cooperative effort with other federal, 
state, and local officials, law enforcement, professional 
organizations, and community groups to address this epidemic.
    Thank you for your invitation to appear today, and I look 
forward to answering any questions that you may have. Thank 
you.
    [The prepared statement of Mr. Rannazzisi follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
            
    Mr. Burgess. The gentleman yields back. I thank the 
gentleman for his testimony.
    We will now hear from the members for questions, 5 minutes 
for each member.
    I will begin.
    Well, Mr. Rannazzisi, you just gave some rather startling 
statistics. Mr. Botticelli, you said in your testimony we can't 
arrest our way out of this problem. So let me just ask you, 
from a federal perspective, we have put a lot of money and a 
lot of effort on behalf of taxpayers into this, what is it 
about this that is not working?
    Mr. Botticelli, we will start with you, and maybe we can 
just go down the line and just answer the question, how has 
this become the problem that it is?
    Mr. Botticelli. Sure. I think a number of my Federal 
panelists have articulated some of the problems, and I think, 
first and foremost, a lot of this issue is driven by the vast 
overprescribing of prescription pain medication. A recent 
report by the GAO showed that the vast majority of physicians 
get little to no training in substance use disorders and little 
to no training in safe opioid prescribing. And a part of our--
--
    Mr. Burgess. Let me stop you there because this is not a 
new problem. I mean this was a problem 40 years ago when I was 
in medical school, and I would disagree with the statement that 
we got no training, but OK, the training may not be adequate to 
the scope of the problem, but honestly, can we say that this is 
something that just happened to us, and we were completely 
unaware that this was an issue? I mean how could you possibly 
make a statement like that?
    Mr. Botticelli. I think part of what the balance has been, 
and I think it has been out of kilter, is that physicians, 
quite honestly, were pushed in terms of making sure that we 
adequately treated pain in the United States. And we absolutely 
need to make sure that we do that. I think we need to have a 
balanced strategy that understands the tremendous addiction 
potential of these drugs, the risky patients that we have 
before us in terms of who should be prescribed prescription 
medication, as well as monitoring those who are developing a 
problem.
    So I do think that this is a balanced approach in terms of 
both making sure that we are adequately treating pain, but we 
are also not inadvertently creating a problem by 
overprescribing these medications to people who are developing 
a problem, or who are at risk.
    Mr. Burgess. I don't want to put words in his mouth, but 
Mr. Rannazzisi seemed to imply that we are overprescribing. Is 
that a fair assessment of your testimony?
    Mr. Rannazzisi. I think that if you are talking about 99.5 
percent of the prescribers, no, they are not overprescribing, 
but our focus is in rogue pain clinics and rogue doctors who 
are overprescribing. Actually, they are prescribing illegally, 
they are not overprescribing, they are illegally prescribing.
    So, yes, if you are considering that overprescribing, yes.
    Mr. Burgess. Well, that is your job. You are law 
enforcement, so you get to close them down, right?
    Mr. Rannazzisi. And we are trying. They are overwhelming us 
with numbers.
    Mr. Burgess. All right, I do want everyone's response to 
that because in the interests of time and wanting to keep to 
the 5-minute interval, I am going to submit that in writing to 
each of you.
    I want to bring up something because each--or several of 
you have brought it up, and that is the issue of making 
naloxone much more available. Maybe we should also be talking 
about making Ambu bags available for people who are going to 
overdose. I mean it is hard to know who is going to overdose, 
but, Mr. Botticelli, you brought it up, and I think, Dr. Sosin, 
you brought it up as well, but what is the issue here with 
making this available?
    Mr. Botticelli. I think that we have been tremendously 
heartened, both at the Federal level, as Dr. Volkow talked 
about, in terms of the approval of new delivery devices for 
doing that. One of the main areas that ONDCP has been working 
with our state partners is the passage of state legislation to 
look at naloxone distribution. And so I think we have now 17 
states that have enacted naloxone distribution legislation, 
which I think has really been helpful here.
    We have also been, quite honestly, working with many law 
enforcement agencies across the state----
    Mr. Burgess. Pardon me for a moment. It is a federally 
controlled substance, is it not? Naloxone?
    Mr. Botticelli. It is not a controlled substance, if I 
remember correctly.
    Mr. Burgess. OK. Is there a cost issue?
    Mr. Botticelli. There is a cost issue, and one of the 
things, Chairman, that you asked is what are the opportunities 
that we have in terms of looking at this, and again, I think it 
was really helpful that SAMHSA looked at how we might use 
existing Federal funds, but I think if there is an area that we 
can continue to explore together it is how we might enhance 
resources for many overdose prevention efforts.
    One of the things that I have heard as I have traveled 
around the country is that having state legislation and having 
these devices is a great start, but many states and local areas 
are under-resourced in terms of implementing it.
    Mr. Burgess. Yes, and again, I may submit that in--for 
answer in writing as well, but, Dr. Volkow, let me just ask 
you. You mentioned in your testimony to address this problem, 
we have to recognize the special character of this phenomenon, 
and part of which is that opiates play a key role in relieving 
suffering. So as providers and policymakers, are we doing a 
good job of walking this line?
    Dr. Volkow. Based on the numbers, I don't think we can say 
we are, and the reality is that in this country, we have both 
an under-treatment of pain and over-prescription of 
medications. These are not exclusive. And one of the issues 
that we have been faced with, and Mr. Botticelli had been 
discussing is, in 2000, when the Joint Committee for 
Accreditation of Hospital demanded that you treat pain, you see 
a steep increase in the number of prescriptions. So what you 
are doing in parallel, there has not been an increase in 
education in medical schools. So each 7 hours average in the 
United States there is a diversity of opiate medications that 
are currently available, and there are many indications where 
actually patients are being given the opioids when it is not 
severe pain, and this, for example, is the case in many cases 
for young people with dentists that are prescribing the opiate 
medication, so there is a room for improvement on that 
education of providers.
    The other issue too that we have not understood very much 
when we were--I mean certainly, when I was in medical school, 
they will tell you if you prescribe an opioid medication with 
someone that is suffering from pain, they are not going to 
become addicted. Now, we can come to recognize that it is not 
the case, that there are patients that are taking the 
medication as prescribed, and they can become addicted. So the 
issue is who are they, how do we recognize them so we can 
prevent that transition. And----
    Mr. Burgess. Well, and my time has expired. I will just 
offer the observation, 40 years ago, I was given the admonition 
by a professor in anesthesiology, this stuff is so good, don't 
even try it once. So clearly, it was known 40 years ago.
    I recognize Mr. Welch for 5 minutes for questions please.
    Mr. Welch. OK, I want to thank the panel and the Chairman 
as well.
    You know, in Vermont, as I mentioned in my opening 
statement, we are just trying to face this directly, which is, 
I think, a much better approach than denial, and it has engaged 
the community in some very effective ways. And it has 
developed--I think it has helped our providers develop what 
they call a Hub and Spoke System where there is an emphasis on 
medication, which really does seem to be helping some folks who 
are willing to be helped, and then some wraparound treatment 
services for people who can benefit by that. And a lot of our 
ability to do that is because we are getting some federal help. 
We get about $6 million out of the Substance Abuse Prevention 
and Treatment Block Grant. That has been level funded. And my 
question really to Mr. Clark, can you explain the decision, I 
guess this is the Administration decision not to propose an 
increase in that program, given the intensity of the crisis. 
And I think with this discussion occurring all around the 
country, obviously, you are going to have many more states that 
are willing to roll up their sleeves and try to get engaged, 
which would suggest the resource need is there in order to help 
make this successful.
    Dr. Clark?
    Dr. Clark. Mr. Welch, we are working very closely with 
state authorities, with organizations like NASADAD and NASMHPD 
to address these issues, but we also, as Mr. Botticelli pointed 
out, are approaching this from a comprehensive approach rather 
than simply using a single funding mechanism to address the 
issue. We need to keep in mind that we need multiple strategies 
to address this problem, and with those multiple strategies, we 
believe that we can make an impact. So relying, indeed, on the 
Affordable Care Act and other strategies, we can leverage the 
Block Grant Funding to target this.
    We are also allowing jurisdictions to prioritize using our 
prevention efforts, as well as our treatment efforts. The 
problems that they are experiencing----
    Mr. Welch. All right.
    Dr. Clark [continuing]. In their respective jurisdictions--
--
    Mr. Welch. OK, thank you. No--but no more money. Money is 
tight, I get it.
    And, Mr. Botticelli, your predecessor came up and had a 
great visit with us in Vermont. It was tremendous to have him 
there. And we have expanded the use of naloxone--how do you say 
that?
    Mr. Botticelli. Naloxone.
    Mr. Welch. Naloxone. Yes, and we have had some success with 
that. We have had a number of instances of it being used 
successfully just recently about 15 times.
    But do you think that the FDA should consider making that 
an over-the-counter medication?
    Mr. Botticelli. Yes. So, first of all, like you, I really 
want to applaud you and Governor Shumlin in terms of calling 
significant attention to this issue. I spent the better part of 
my career in Massachusetts, and am very familiar with----
    Mr. Welch. Right.
    Mr. Botticelli [continuing]. The heroin issue that we have 
had in New England for a long, long time.
    Our office, as part of our prescription drug abuse plan and 
overdose, has been looking for continued ways to expand the use 
of naloxone. Again, I think we are heartened by this delivery 
device. Our partners at NIDA are looking at and researching the 
expansion of and use of other ways. So we are having 
conversations with both Federal partners and, quite honestly, 
some external stakeholders who are really, really interested in 
terms of looking at how do we increase the--not only the 
availability of naloxone, but continue to promote easier to use 
and, quite honestly----
    Mr. Welch. OK.
    Mr. Botticelli [continuing]. Perhaps some cheaper versions 
of----
    Mr. Welch. Right.
    Mr. Botticelli [continuing]. Naloxone.
    Mr. Welch. I have time for one more question.
    Dr. Volkow, I want to ask you about this issue with doctors 
and with patients. I have known close friends who have had 
serious medical issues and have been in a lot of pain, and once 
that line is crossed where they are getting the prescription 
medication, it almost seems like there is an undertow where the 
answer to the pain question always is essentially to get more 
medication and more powerful medication. And a patient in that 
moment is pretty vulnerable. And the doctor gets really 
persistent advocacy by the patient and sometimes the patient's 
family. You have got to do something. So how do we help the 
doctors deal with what, Dr. Burgess, of course, we have another 
doctor here, but how do they, there are a lot of doctors around 
here, but how do we--the doctors really have to be on the 
frontline, and it is very tough because they have a patient who 
is in pain, they have a family who is saying will you do 
something, but the something that is getting done in many cases 
is resulting in long-term problems.
    Dr. Volkow. Yes, and you are touching on one of the hardest 
issues to deal with clinically: how do you manage severe 
chronic pain. What many people don't know is that the risk of 
suicide for patients with chronic pain is double that of the 
general population, so it is extraordinarily debilitating. And 
the strongest medication we have are opioids. The problem with 
opioids, apart from addictiveness, is that you become tolerant 
very rapidly, and so that requires that you increase the dose. 
So chronically, and then you have to shift to something more 
potent, and that is exactly where the whole problem lies 
around. They are not ideal, but it is what we have, and it can 
relieve the patients in the moment that they need them.
    The strategy is what other alternatives we can use other 
than just relying as--in opioids as the only alternative, and 
that is where research is ongoing to see--that is what I was 
mentioning in the whole area of brain neuroscience, the 
feasibility of devices that can actually be used potentially to 
handle and manage pain will be a breakthrough. You will rely 
less on medications. And I also think the aspect of we as a 
society have created the expectation that anything that is 
wrong with you should be treated with a medication. So zero 
tolerance for pain. And I think that as a culture, we need to 
revision that also.
    Mr. Welch. Thank you.
    I yield back. Thank you very much.
    Mr. Gingrey [presiding]. Thank you. Thank you, Mr. Welch.
    And I am sitting in, obviously, for Dr. Burgess. Let me 
just make a brief statement, and then I will ask my question.
    As a physician of many years, I don't think that even back 
in the day we were given the proper training in regard to pain 
medication. Also I will say this, there has been a lot of 
emphasis over the past 10 years or so about advanced directives 
and the necessity for that, and, of course, the hospice 
programs that have developed and that sort of thing, but I 
don't hear hardly any discussion about patients given their 
wishes in regard to how they want their pain controlled in a 
terminal situation where there is no chance for recovery. I 
don't know that people really understand, and in many instances 
pain medication is started because the family members don't 
want their loved one to suffer. That is quite natural and 
appropriate, but before you know it, the patient has gone 
beyond the stage where they can say, look, I don't want to be 
totally zonked out at the time of my demise. So that is just, I 
guess, food for thought in a way.
    I am going to ask my specific question, Mr. Rannazzisi. You 
said earlier in your testimony that the DEA is just getting 
overwhelmed by all these rogue pain clinics that are popping up 
everywhere. How is that happening? How do these places just pop 
up, as you put it, and why is it happening, why are you getting 
overwhelmed?
    Mr. Rannazzisi. Well, that is a great question, sir. It is 
not just DEA that is overwhelmed. Our state and local 
counterparts are overwhelmed. Think about this. Prior to the 
Ryan Haight Act, the Internet drug bill that was passed, there 
were, say, seven clinics--pain clinics in Broward County, in 
2010 there were 142 clinics in Broward County. Now, if you 
look, when we moved our enforcement groups down there, and we 
moved 10 tactical diversion squads to work with our state and 
local counterparts, and we started knocking off these rogue 
pain clinics, they moved up into Georgia. If you looked at the 
75 corridor, there were over 100 pain clinics going up that 75 
corridor. Some of them were right off of the interstate. You 
just get off and get back on. Then they moved into Tennessee. 
Tennessee now has approximately 300 clinics.
    Now, if you think that--state and local law enforcement and 
DEA doesn't have the capacity to go after every one of these 
clinics quickly, because these are legal drugs that they are 
peddling, and we have to establish that that doctor is 
prescribing outside the usual course of professional practice, 
and not for legitimate medical purposes. It takes time. These 
cases take time. So what they are doing is they are just 
counting on the fact that they are going to run the clinic that 
is not being hit by DEA. So we are all overwhelmed, everyone in 
law enforcement.
    Mr. Gingrey. Yes, but what percentage would you say of 
these clinics are fraudulent?
    Mr. Rannazzisi. In Florida, the vast majority of them. In 
Georgia, I believe that the vast majority of those clinics that 
popped up were. There are good pain clinics, don't get me 
wrong. Every pain clinic is not bad.
    Mr. Gingrey. Yes.
    Mr. Rannazzisi. But the pain clinics that we are looking at 
are absolutely atrocious. There is no medical care.
    Mr. Gingrey. Yes.
    Mr. Rannazzisi. It is the modern-day crack house.
    Mr. Gingrey. Thank you for that answer.
    And any of you could answer this. Last year, GAO, the 
Government Accountability Office, found an overlap in 59 of the 
76 programs it identified in the drug abuse and prevention 
area. What steps are any of your agencies taking to minimize 
overlap and more efficiently spend out taxpayer dollars? I mean 
you would think that we could get some efficiency here. 
Anybody?
    Mr. Botticelli. Sure, Chairman. Our office has looked at 
that report and has been working with our Federal partners to 
look at the breadth of our prevention programs, and to make 
sure that we are not, quite honestly, duplicating programs.
    I do think that, however, if you talk to many, many people 
at the local level, they will tell you, however, that we don't 
have enough prevention, and I think you heard from many, many 
folks up here that while we may have programs that are 
addressing the same issue, they are reaching not the entirety 
of the population. So we really want to make sure that, one, 
that we are not kind of duplicating the programs that we have 
already----
    Mr. Gingrey. Well, very important, I would think that you 
guys are talking to each other, of course. Others? I have a 
little time left, 2 seconds, 1 second. Wait a minute, I am the 
chair now, aren't I? I have 5 minutes left. Mr. Clark?
    Dr. Clark. Well, as----
    Mr. Gingrey. Dr. Clark, excuse me.
    Dr. Clark. One of the things we are concerned about in the 
Administration is the issue of fragmentation, overlap, and 
duplication, and that we do work very closely with our federal 
partners to make sure that we minimize fragmentation, overlap, 
and duplication. And working under the assistance of ONDCP, we 
are able to address that.
    As was pointed out, communities need multiple resources, 
and you find that sometimes you cannot completely eliminate 
some overlap because, indeed, the unique issues of individual 
communities require that there be some overlap, but we are very 
sensitive to both the GAO concerns and OMB's concerns about 
fragmentation, overlap, and duplication, and assiduously try to 
avoid that.
    Mr. Gingrey. Thank you all. I thank the panel. My time has 
expired, and I yield 5 minutes now to Mr. Lujan.
    Mr. Lujan. Mr. Chairman, Doctor, thank you so very much for 
the time today, and I am glad to see that we are having this 
hearing. This is important. By the chairman and the committee 
staff acknowledging that this hearing needed to take place, I 
think we are acknowledging there is a problem across the 
country.
    The question after this hearing today though is, are we 
going to sweep this under the rug again, or are we going to do 
something significant with recommendations that are going to 
come from experts?
    This is a problem plaguing America. The case in New York 
brought more attention to what was happening with heroin abuse 
and overdoses, but we have been losing lives across the country 
for years. And what are we going to do? There are 
recommendations that have been put on the table by many 
experts. It has been studied over and over and over. There is a 
program from 2011 on the prescription drug side to reduce abuse 
significantly over 5 years, I will be asking the question where 
are we with that, but every life that is lost as a result of 
this is one life too many.
    There are only so many parts of the world that are growing 
poppies. Do we not know, as the United States of America, where 
poppies are being grown and how they are migrating into the 
United States in the form of heroin and illegal substances? 
Seems to me we should. And what are we doing to stop that flow? 
That is very troubling.
    Now, going back to the prescription drug side, there have 
been presentations that we have seen in New Mexico that have 
been put together by some people that I respect very much, that 
show a correlation with drug overdoses with increased 
prescriptions that are coming out, not just pain medication 
facilities that are popping up. And so one of the questions 
that I have is, is there data that is reported to any of you 
that you do analysis on, where there is a court--at least with 
the data that I have seen, there is--it is shown that there is 
a correlation between overdoses and increased prescriptions 
that are being administered, and what do we do with that data? 
Are we able to go in or is that an area where we don't have 
enough support now between the federal and the state partners? 
And I would ask anyone that would like to tackle that.
    Dr. Sosin. Thank you, Congressman Lujan.
    You mentioned a New Mexico report. Dr. Paulozzi from CDC 
worked with scientists in New Mexico and health department 
staff there to analyze and demonstrate those relationships, and 
absolutely, there is a very tight relationship between the 
volume of opioid prescribing and opioid overdose deaths. That 
information does get used at a national level, and thinking 
about the areas to intervene, but also at the state and local 
level where it has to be, to better understand how the problems 
in each individual jurisdiction, and the factors that are 
influencing the prescribing practices are being addressed 
there.
    One of the ways that CDC in particular works is by trying 
to liberate data by working with state and local health 
departments to understand the context of prescribing, of health 
system data, and of mortality data, to put a better picture and 
understand the context within which overdose deaths are 
occurring and abuse is occurring, and then be able to target 
programs like through their PDMP's, like restriction programs, 
et cetera, that address those problems.
    Dr. Volkow. If I may, first of all, I want to thank you for 
bringing up that issue because the way that I view it, this is 
an urgent issue and we cannot put it under the rug, under no 
conditions. And I feel passionate because I do get the parents 
coming to me and say when we went to wake up our child, it was 
dead, and we didn't even know that they were abusing opioids.
    The other issue is that we do have the tools to actually 
address the problem of opioid prescription abuse and opioid 
deaths. We need to implement them. We have treatments that work 
for drug addiction that can decrease the number of overdoses, 
but also we need to address the problem that we have with 
chronic pain in this country. How many people suffer chronic 
pain in this country? Estimated IOM, 100 million. 100 million. 
There is the notion on that 100--that there is an increase in 
chronic pain, and that needs to be addressed. So from the 
healthcare perspective, we need to address it.
    Mr. Lujan. And, Dr. Volkow, as my time expires, there are 
some questions that I will be submitting in to the record, but 
I would welcome your response as well.
    And, Mr. Chairman, I just wanted to share with you that 
there is a program in New Mexico that appears to be working 
with the distribution of Narcon, where there has been a 
reversal of more than 250 overdoses last year, where they are 
getting it into the hands of first responders and nurses. So it 
is not necessarily on the street, but it is with those that are 
responding to these accidents. And there may be a way for us to 
work on that with some ideas down the road.
    Mr. Chairman, again, I share, before you return to the 
hearing, how much we appreciate that you are doing this and you 
have brought this hearing, but I certainly hope that there is 
more that will be done, and that this hearing won't be the last 
of hearings and conversations, and an approach that we can take 
as a Congress to work with our state partners to do something. 
This is a bad problem across the country, but it is also 
plaguing New Mexico. And I thank you for your attention to 
this, Mr. Chairman.
    Mr. Burgess. The Chair thanks the gentleman, and does also 
observe that further hearings are likely to be necessary, and 
as Mr. Welch pointed out, to hear from governors, and I would 
like to hear from some of our mayors because they are on the 
first lines of this battle.
    The Chair now recognizes the gentlelady from North 
Carolina, Mrs. Ellmers, 5 minutes for questions please.
    Mrs. Ellmers. Thank you, Mr. Chairman, and thank you to our 
panel for being here today, addressing this very important 
issue.
    I would like to start by asking a question of Mr. 
Botticelli and Dr. Volkow.
    Understanding the path of addiction, there is, and I think 
you have both identified a genetic basis for that, one of the 
things I would like to know is, again, the progression. Is this 
something that starts with tobacco use, smoking, use of 
alcohol, drinking, and then how does it progress and how do you 
feel? And I will just start with you, Mr. Botticelli, and then 
have Dr. Volkow comment.
    Mr. Botticelli. I do have to acknowledge that just about 
everything that this field knows about this has come from the 
work of Dr. Volkow.
    Clearly, we know that there is a genetic predisposition for 
many people in terms of family history of substance abuse, but 
we also know that there is, like many diseases, there are 
environmental factors that go into that issue.
    We know that substance use disorders are a disease of early 
onset, so that many people who do develop, left untreated, left 
undiagnosed, develop a substance use disorder, largely because 
of starting alcohol, tobacco and/or marijuana use----
    Mrs. Ellmers. Yes.
    Mr. Botticelli. At a very young age. Clearly, there are 
some particular issues as it relates to the addiction potential 
of prescription drug medication----
    Mrs. Ellmers. Yes. Yes.
    Mr. Botticelli [continuing]. But the vast majority of 
people that, at least, I have talked to, and the data show that 
those folks who do have a significant opioid use disorder have 
started from a very young age. And if you saw the Philip 
Seymour Hoffman story, he actually started with alcohol abuse 
at a very young age. So we know that there are prevention and 
intervention opportunities that we can have along the way to 
really make sure that we are identifying people early in their 
disease progression, and then we are intervening in this issue.
    Mrs. Ellmers. Yes.
    Mr. Botticelli. The other piece that you talked about, and 
again, I think it still warrants further work, is what about 
the progression from prescription drug use to heroin addiction.
    Mrs. Ellmers. Yes.
    Mr. Botticelli. Clearly, we know that it is a progressive 
disease, and people, left untreated, will often progress to 
more significantly harmful use patterns, but we also know that 
price plays a role, as the DEA mentioned, in terms of the 
progression. So we know that there are multiple factors that 
really affect peoples' progression, not only in terms of 
overall development of a substance use disorder, but from 
prescription medication to heroin.
    Mrs. Ellmers. Yes. Yes. Dr. Volkow?
    Dr. Volkow. Yes, and the questions you ask intrigue many 
scientists, and it is called--has led to the term of gateway--
--
    Mrs. Ellmers. Right.
    Dr. Volkow [continuing]. Hypothesis because all of the 
epidemiological studies have repeated corroborated that most 
individuals that become addicted to illicit substances started 
with nicotine or alcohol, then transition into marijuana and 
then the other drugs. So the question is that just because it 
is more accessible that you start with nicotine or alcohol----
    Mrs. Ellmers. Yes.
    Dr. Volkow [continuing]. Or could it be that these drugs, 
including nicotine, alcohol, and marijuana, are changing your 
brain in such a way that it makes it more receptive to the 
addictiveness of drugs.
    Mrs. Ellmers. Yes.
    Dr. Volkow. And there is data now from genetic studies and 
from studies in animals that suggest, at least for the case of 
nicotine and alcohol, and also marijuana, that it is changing 
the sensitivity of the brain reward sequence in a way that 
primes you----
    Mrs. Ellmers. Yes.
    Dr. Volkow [continuing]. To the addictiveness of these 
other drugs. And in the case of prescription opioids, that is 
also what they are observing, that most of the individuals that 
end up addicted to prescription opioids had a history of 
nicotine addiction earlier, or had started abusing alcohol.
    Mrs. Ellmers. Yes. Thank you.
    My last question is for Mr. Rannazzisi. Obviously, your 
agency is working with many other agencies on this issue, and I 
am going to ask you a question that really falls under the FDA, 
but from your opinion, in the work that you are doing, do you 
believe that some of the prescription drugs, the deterrent 
formulas such as, you know, for Oxycontin, some of the 
deterrent formulas, will that make a difference and is it 
feasible that if we take this approach, that that is going to 
help on the wide and broad scope that you have outlined if we 
are using these deterrent forms?
    Mr. Rannazzisi. Absolutely. The abuse deterrent 
formulations will make a difference. But those drugs will still 
be abused----
    Mrs. Ellmers. Yes.
    Mr. Rannazzisi [continuing]. Orally with a potentiator, 
like a muscle relaxer, or a Benzo, but in the end, it is going 
to stop them from crushing and snorting, or crushing and 
injecting.
    Mrs. Ellmers. Yes.
    Mr. Rannazzisi. And we know that when you crush and inject, 
or crush and snort, you are raising the risk----
    Mrs. Ellmers. Yes.
    Mr. Rannazzisi [continuing]. Of overdose and death----
    Mrs. Ellmers. Yes. Yes.
    Mr. Rannazzisi [continuing]. Just in that method of 
delivery. So, yes, do I think it is important? Absolutely, it 
is important. Look at what happened with the Oxycontin product, 
when it went from the OC to OP, you could bang that tablet with 
a hammer and it is not going to break.
    Mrs. Ellmers. Yes.
    Mr. Rannazzisi. It balls up in your nose when you try to 
snort it. It is crazy----
    Mrs. Ellmers. Yes.
    Mr. Rannazzisi [continuing]. That, if you try to abuse that 
drug, but what do we see everybody doing? Immediately, they 
started moving to the Oxymorphone product----
    Mrs. Ellmers. Yes.
    Mr. Rannazzisi [continuing]. Or the immediate release Oxy 
30s. OK, so they are adapting.
    Mrs. Ellmers. Yes.
    Mr. Rannazzisi. If we could figure a way to get an abuse 
deterrent formulation across the board, then we are going to 
see some significant results----
    Mrs. Ellmers. Thank you.
    Mr. Rannazzisi [continuing]. Absolutely.
    Mrs. Ellmers. Thank you so much for your answers, and your 
insight on this issue.
    And, Mr. Chairman, I yield back the remainder of my time.
    Mr. Burgess. Gentlelady yields back.
    The gentleman from Kentucky, Mr. Yarmuth, recognized 5 
minutes for your questions please.
    Mr. Yarmuth. Thank you very much, Mr. Chairman. And I thank 
the panel as well for the testimony, and for what is obviously 
a very committed effort across the spectrum of government to 
deal with this problem. I am glad to know that, I shouldn't say 
glad, but it is somewhat reassuring to know that this is not 
just a Kentucky problem. Certainly, in my travels in my 
district and around the state, and talking with law enforcement 
and with mental health professionals, and everyone who is 
involved in this area, we have a huge problem in Kentucky. 
During the first 3 quarters of 2013 there were at least 170 
Kentuckians who died from heroin overdoses, and that was 41 
more people who had died the entire previous year, and is 
actually a 200-plus percent increase since 2011. So we have a 
problem that is there and growing.
    And one of the young people who died was the nephew of a 
Kentucky state representative, Joni Jenkins, a good friend of 
mine and a great representative. Her nephew, Wes, they 
suspected, began with prescription drugs and then moved to 
heroin because of expense. He died in May of 2013. And she told 
her story in the Louisville Courier-Journal, and I would like 
to read one of the things she said because it prompts a 
question. She said, for an entire year, our family kept the 
addiction private. They were well aware of it, he had been in 
and out of treatment and they were working with him, but they 
kept it private so Wes would not suffer the social stigma of 
being a drug addict. I now know that there is a terrible shame 
attached to this illness, but we have to break through the 
silence to find a cure. And she said, I also know that I will 
search for answers the rest of my life for that.
    Is this a problem that you have seen? You are nodding your 
head, Mr. Botticelli, so respond to that, that much of the the 
access to treatment or the willingness to treatment is deterred 
because of a social stigma?
    Mr. Botticelli. I have--and many of us have heard that 
story countless times from parents. Many of us were just in 
Atlanta with a conference sponsored by Chairman Rogers. And we 
hear that story repeatedly, and I think our collective efforts 
have really been to raise the visibility of ensuring that 
people know that addiction is a disease, and this is not about 
shame, this is not about guilt. We know that one of the reasons 
why people don't seek treatment, and why parents don't ask for 
help, is because of the shame and embarrassment that is related 
to that. And so part of what I think all of our Federal 
partners are doing is how do we raise the understanding and 
visibility, and, quite honestly, the compassionate treatment of 
people with addiction--of addictive disorders into this work. 
And I think that we are seeing, quite honestly, a movement in 
terms of--like we did with other disorders that were shameful 
and stigmatized----
    Mr. Yarmuth. Yes.
    Mr. Botticelli [continuing]. That we have to elevate the 
voice of parents and people in recovery so that we do know that 
hope is possible, and that it would be easier for them to come 
forward and ask for help, but unfortunately, we have heard that 
story way too many times from----
    Mr. Yarmuth. Yes.
    Mr. Botticelli [continuing]. From parents and people who 
are affected.
    Mr. Yarmuth. Have you come up with any great answers? I 
mean what can we do to help that just as individual members? We 
do span the country anyway.
    Mr. Botticelli. Yes. I think there are a couple of things 
that we are doing. A lot of our work at the Office of National 
Drug Control Policy, we actually established an Office of 
Recovery to really promote the fact--we are looking at the 
development of recovery support services, so that people in the 
community can see that recovery is possible. I think we have 
been promoting--those of us who are in recovery, talking very 
publicly about the fact that we are in recovery, because it 
shows to other people that this is not just about death and 
destruction, that there really is hope on the other side of 
this. So I think all of us play a role in terms of 
destigmatizing that.
    Just having these hearings really shows the fact that we 
have leadership in this country who are concerned about this, 
and it is not a shame. This is not a moral choice, this is not 
a moral failing, this is about a disease, and we have to deal 
with it from a public health perspective.
    Mr. Yarmuth. Yes.
    Mr. Botticelli. So I really appreciate your acknowledgement 
of that--those challenges.
    Mr. Yarmuth. Well, it seems to me that much of this problem 
involves education. I assume that when these young people, or 
whether it is young or not, but predominantly young people 
begin on prescription drugs, they have no idea that this is the 
course that they could likely be on. And I don't know whether 
that is a school issue, a PTA issue, what it is, but it seems 
to me like information is one of the greatest avenues for 
combatting this problem.
    Well, anyway, Mr. Chairman, I would request unanimous 
consent that this OpEd that I mentioned from Joni Jenkins be 
made a part of the record.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Yarmuth. Thank you, and I yield back.
    Mr. Burgess. The gentleman yields back his time.
    The Chair now recognizes the gentleman from Ohio, Mr. 
Johnson, 5 minutes for your questions please.
    Mr. Johnson. Thank you, Mr. Chairman, and I really 
appreciate the opportunity to hear from the panel today on this 
very, very important issue.
    You know, prescription drug and heroin abuse are very 
serious--is a very serious epidemic in Ohio, and parts of my 
district in eastern and southeastern Ohio are some of the worst 
hit.
    In 2012, 5 Ohioans died every day from unintentional drug 
overdose with opioids, both prescription and heroin, as the 
driving factor. Attorney General Mike DeWine identified heroin 
as contributing to as many as 11 fatal overdoses a week. It is 
a major public health crisis. However, prescription opioids 
continue to be the lead contributor to fatal overdoses in the 
state. In 2012, for example, an average of 67 doses of opioids 
were dispensed for every Ohio resident.
    Law makers, nonprofit organizations, medical, industry 
leaders, communities and parents across the state have been 
working to coordinate their response to this epidemic, but in a 
corner of Ohio that shares borders with 3 other states, 
communities are struggling to get drug abuse under control. 
Individuals identified as abusing in one state may cross state 
lines to escape detection and abuse in another. A nonintegrated 
system also makes it harder to identify prescribing providers 
and pill mills.
    So for all of you on the panel, anyone that wants to try 
and respond to this, I realize that states are largely in 
charge of implementing their own prescription drug monitoring 
programs, but in multistate areas like I serve, the importance 
of working together to curb abuse cannot be emphasized enough. 
So what is being done at the federal level to encourage states 
to share information compiled by their respective PDMPs?
    Mr. Botticelli. Thank you, Congressman, and as you have 
articulated, both the establishment of vibrant prescription 
drug monitoring programs, and, quite honestly, the interstate 
interoperability of those programs, has been key for much of 
the work that we have been doing on the Federal level. So, we 
are happy that in 2006 we only had about 20 operable 
prescription drug monitoring programs in the United States, and 
now we have 48 that are operable, one in the process and 
unfortunately, one state that doesn't have a prescription drug 
monitoring program. And as part of this strategy, we have been 
working with the Bureau of Justice Assistance and the Boards of 
Pharmacy to really look at interstate operability so that those 
states that share a border can make sure that they are sharing 
data. So now we have 20 states that are able to share 
information across borders, and clearly, we have a goal of 
making sure that all of these programs share data among 
particularly neighboring states.
    Mr. Johnson. Yes, I will share with you that, as a 30-year 
IT professional myself, I can tell you that architecture and 
data standardization, interface standards, those are very, very 
critical components. If you don't know where you are going, any 
road will get you there. And it is one thing to have a 
monitoring system, it is quite something else to have a 
monitoring system that adheres to standards so that it can be 
effectively used.
    How do we make the nationwide PDMP system more effective, 
and what still needs to be done to fully achieve a fully-
integrated network?
    Dr. Sosin. Congressman Johnson, thank you for your 
question. Clearly, the PDMP and the ability to achieve 
successful, effective PDMPs is critical to the law enforcement 
side, the public health side as well, the clinical side as 
well. And as Mr. Botticelli commented, we are making progress, 
meaning that we are better understanding the components of 
these PDMPs, and what it is that needs to be shared and how to 
share them. The work that you all are doing in raising 
visibility, that governors and mayors are doing, saying that 
this is an issue that they are going to address, also allows 
this opportunity to set the standards for what we need to share 
and how we will share that information across borders.
    The CDC, working with the FDA and the Bureau of Justice 
Assistance, has been funding at Brandeis, the prescription 
behavioral surveillance system, which takes from 20 states the 
PDMP data they have, to better understand what these factors 
are that increase the success of PDMP's.
    Mr. Johnson. Let me get to one more quick question. I have 
to move quickly.
    How can we shift drug abuse prevention efforts from the 
collection of silo data like we are talking about, to a system 
in which this information isn't lost every time an individual 
realizes that they are being tracked, and takes evasive 
measures like leaving a health plan, for example, because not 
only do you have working across state lines, but an abuser that 
goes from one health plan to another can also hide. So how do 
we solve that problem?
    Mr. Botticelli. And some of my colleagues can add on to 
this, but part of what we have been really trying to focus on 
is make sure that we are treating and integrating substance use 
issues as part of mainstream healthcare, of really looking at 
things like making sure that people are getting screened and 
intervened as part of their overall health plan so that, you 
know, for a very, very long time, we have had two systems of 
care in the United States. We have had medical care over here 
and behavioral healthcare over here, and that we haven't 
necessarily really looked at how we make sure that we are 
treating substance use disorders as a medical condition.
    So part of our goal is more thorough integration of mental 
health and substance use services within our primary care 
settings----
    Mr. Johnson. Sure.
    Mr. Botticelli [continuing]. Because it is really important 
that we not see these as two separate issues.
    Mr. Johnson. Yes.
    Mr. Chairman, I have many, many more questions. Obviously, 
this is a complex and sensitive issue for many Americans, but I 
have run out of time so I yield back. Thank you.
    Mr. Burgess. The Chair thanks the gentleman. The gentleman 
yields back his time.
    The Chair recognizes the gentlelady from Florida, Ms. 
Castor, 5 minutes for your questions please.
    Ms. Castor. Thank you, Mr. Chairman, and thank you to the 
panel very much.
    This hearing is really hitting home for me today because 
yesterday I learned that the death of a friend last month was 
tied to her long-term opioid addiction. Her sister sent me an 
email, I got it just yesterday, and she committed suicide, and 
her sister said because of her long-term addiction. So she left 
a daughter and a husband and an entire family, and the sister 
is asking please do more. So I hope we can all come together to 
tackle this. It is causing so much pain for so many families.
    And the State of Florida has really been at the heart of 
the problem. And still in Florida, they say that every 7 to 8--
every--I can't believe it, 7 to 8 minutes, someone overdoses in 
the State of Florida. I am also hearing from my local 
hospitals. They have had to add rooms in the NICU units of 
hospitals because of babies being born addicted, and these 
babies typically will cost $1 million to take care of, and they 
are in the hospital for a month. So we had better invest in 
prevention or else we are going to be spending a lot on the 
outside.
    So, Mr. Rannazzisi, Florida--the general talking points 
are, well, Florida has improved. There was a huge law 
enforcement crackdown. We have adopted a prescription drug 
tracking system, the PDMP. The problem is that doctors are not 
using it. The last statistics I saw, only 3.5 percent of all 
prescriptions being written are being checked on that database.
    What is your view right now in Florida? Have we made 
progress? What is left to do?
    Mr. Rannazzisi. I think under the leadership of Attorney 
General Bondi and law enforcement leaders down in Florida, yes, 
we have made progress, absolutely. The problem is, again, we 
are overwhelmed by the numbers. There are so many people down 
there in Florida. We actually have cases where Florida rogue 
pain clinic operators were funding clinics in northern states, 
so when when the heat is on them, they are going to move into 
another state.
    I think that we are making progress, but again, it is going 
to take time. Now, the PDMP issue, I would love to see mandated 
PDMP use. The National Association of Boards of Pharmacy have 
gone out of their way to ensure that there is interoperability 
and interconnectivity between the PDMP's. I think they have 25 
states that are already connected, and they have done a 
phenomenal job, but if no one is looking at that PDMP, or very 
few are looking at that PDMP, it is not going to help.
    Ms. Castor. So do you agree that the local law enforcement 
efforts--what I see on the ground in my community, in the Tampa 
Bay area, we used to have these long lines with cars from out 
of state, people waiting outside in the alley for these pill 
mills to open up. You don't really see that anymore, but with 
these statistics on the rate of deaths from overdose, something 
else is happening. We are not really making a dent there. Has 
it shifted to the internet, are they going out of state, is it 
both? What is going on?
    Mr. Rannazzisi. I think they are moving to more rural areas 
where there is less law enforcement presence. I think the 
operators understand--I have a great video I would have loved 
to have shown you of a clinic, and what happens as soon as the 
clinic opens. I think that they are adapting. The clinic owners 
are adapting very well, and they are one step ahead of us right 
now, but in the end, local law enforcement is doing a 
phenomenal job, and they are moving people out of the Tampa Bay 
area and out of the 3-county area, but it is still there----
    Ms. Castor. Yes.
    Mr. Rannazzisi [continuing]. It is just moving to more 
rural areas where they can't address the problem as quickly.
    Ms. Castor. So in this very sad e-mail from my friend that 
I got yesterday, she said she has read now about the FDA 
approval of Zohydro, pure Hydrocodone, non-tamper resistant, 10 
times stronger than Vicodin, the Vicodin prescription opiate. I 
know that the Advisory Committee to FDA had some very serious 
concerns with this, yet it has been approved.
    Dr. Volkow, could you give me your opinion on whether this 
drug should be readily available?
    Dr. Volkow. Well, we clearly have a very large number of 
opioid medications, and we are overprescribing them. I wouldn't 
point my finger at one or the other. I do think that the 
feasibility of getting formulations that cannot be diverted is 
something that is very powerful, and the FDA should be 
commended because it came up--pharmaceuticals can come up with 
an indication for a medication that is deterrent proof, and 
that is incentivizing to the development of these types of 
medications.
    Zohydro is Hydrocodone, it is slow delivery over 12 hours, 
and it actually does not have Acetaminophen, and because the 
way that you have--correctly which is Vicodin, the way that you 
have it is combined with Acetaminophen which produces liver 
toxicity, which led the FDA to consider if someone needs 
Hydrocodone, do you need to give them Acetaminophen, and it was 
in that context that they approved it----
    Ms. Castor. And----
    Dr. Volkow [continuing]. But----
    Ms. Castor [continuing]. Could I ask, since my time is 
short, Mr. Botticelli, do you agree with the FDA's approval, or 
do you have concerns?
    Mr. Botticelli. I think the important point, and again, I 
don't think the FDA has their own process in terms of how they 
approve medications. I would agree that how we continue to make 
sure that we have abuse-deterrent formulations is really 
important. I also think that this really underscores the 
importance of prescribing, and training on prescribing, because 
I think the point is that we have many medications that are 
open for a potential to abuse, and we want to make sure that 
physicians and other prescribers really understand the risks 
associated with these drugs.
    Ms. Castor. And, Mr. Rannazzisi, local law enforcement has 
expressed concern about this new drug on the street because it 
is so potent, and because it is likely, if a child takes it, it 
could death. What is your view?
    Mr. Rannazzisi. Yes, local law enforcement and DEA and our 
federal partners have all expressed. We all lived through the 
Oxycontin problem back in the '90's into the 2000's, and we 
just don't want history to repeat itself. Too many people 
passed from the abuse, circumventing that delivery system.
    Mr. Burgess. The gentlelady's----
    Ms. Castor. And my----
    Mr. Burgess [continuing]. Time has expired.
    The Chair recognizes the gentleman from Virginia, Mr. 
Griffith, 5 minutes for your questions please.
    Mr. Griffith. Well, let me pick up there. You are concerned 
about this newer drug, and so my question is what do you all 
do, and I would ask it of all of you but I start with you, Mr. 
Rannazzisi.
    Mr. Rannazzisi. Rannazzisi.
    Mr. Griffith. Rannazzisi, thank you. And that would be, how 
do we do a better job of predicting where we are going to see 
spikes and abuse on drugs as they come forward, because some 
people say that we should have probably seen the increase in 
the prescription drug abuse of opioids and heroin?
    Mr. Rannazzisi. Well, we monitor the amount of drug going 
into a particular state through our ARCOS system, but in the 
end, what we generally see is the drug being abused in the 
Appalachian area of the country, and then it spreads out from 
there. So when we were looking at Oxycontin, for instance, the 
Oxycontin abuse epidemic started in that area, Kentucky, 
Tennessee, southern Ohio----
    Mr. Griffith. Southwest Virginia.
    Mr. Rannazzisi. Yes, southwest Virginia--well, yes, 
absolutely. And then spread out. And we believe that pattern is 
going to happen again with this new product. It is just a 
matter of time. We know that product is now in the pharmacies 
and being dispensed, so----
    Mr. Griffith. And, now, for the people that we--that you 
have identified, I think that one of the other speakers said 
abuse-deterrent formulations. Once we know somebody is abusing, 
I have always liked the lock-in, where you lock into a pharmacy 
and you lock into a doctor, because one of the problems in 
southwest Virginia that you mentioned a minute ago is, is that 
you can be in West Virginia, Tennessee, Kentucky and North 
Carolina all within--no matter where you are in southwest 
Virginia, within an hour or 2 hours, you can be in any one of 
those states because of the way the geography is, and you can 
go from one rural area to another.
    So what are we doing on that? Are we looking at that as a 
possible means? Dr. Clark, if you want to answer, that is fine. 
I am just trying to find answers.
    Dr. Clark. Clearly, there is no simple answer, and your 
question is a very important one, and this committee is trying 
to address it. We are working with the Association of State and 
Territorial Health Offices, and the Federation of State Medical 
Boards, and the Boards of Pharmacy. We do collect surveillance 
data from our household survey and working with our colleagues 
in the CDC, so part of the issue is monitoring the movement of 
individuals, getting practitioners, whether they are 
pharmacists, nurse practitioners or physicians, to monitor what 
it is that they are doing. Getting people to access and 
actually use the PDMPs, and having interoperability, as was 
pointed out. So--and then involving community coalitions, 
because, as was pointed out from the representative from 
Florida, people know where the places are. And what we need to 
do is----
    Mr. Griffith. Sure.
    Dr. Clark [continuing]. To get community coalitions----
    Mr. Griffith. Well, that is why----
    Dr. Clark [continuing]. To carry that information.
    Mr. Griffith. That is kind of why I like the lock-in 
because then, you lock them into a doctor, into a pharmacy, if 
you know, now, I don't want to do that to folks who haven't 
been identified as having a problem, but once you know they 
have a problem, then that gives you a better handle on what 
they are doing if you lock them in and that is the only place 
they can go. Wouldn't you agree, and I need to hurry because I 
have other things I want to ask?
    Dr. Clark. That is one strategy that can be employed. So 
you want to make sure that if you do that, that they have 
access to the resources necessary to be in that----
    Mr. Griffith. Sure. And here is the dilemma that we have, 
because one of the things that the DEA is--has done, and we 
talked about this the last time you were here, is that they are 
asking the distributors to, you know, say, OK, don't sell so 
much to a pharmacy if that pharmacy looks like they are above 
the average, or if you see some sign that they may be abusing. 
And I told the story about what happened when I went to my 
local pharmacy, and there were two people in there who were 
both being told you have to come back next month, which was not 
a few--but a few days away, because we used up our allotment. 
And I intuited that maybe they only had 1 supplier, and then 
that supplier said, he's above average for other people who 
have more than 1 supplier. I went back and checked and that is 
exactly what is going on. He didn't know that was the problem, 
but I said, you only have one supplier, don't you? He said, 
yes, I use one distributor. And I think that is the problem.
    So we have on the one hand, we want to lock out people who 
are abusing it. On the other hand, we want to make sure people 
who need it, get it. So I guess what I am saying in the second 
matter is, for the rural areas, it may be a problem because 
that is less law enforcement, and we recognize that, and why a 
lot of my region is in different HIDA designations. At the same 
time, you want to make sure people are getting the drugs they 
need, and if you are in a rural area, you are a small pharmacy, 
you may only be using one distributor. While the DEA doesn't 
have a quota, the distributor then is putting a quota on 
because, based on other pharmacies, that particular pharmacist 
or drugstore is ordering more drugs, but it is because they are 
only using the one supplier as opposed to using two or three.
    How do we solve that problem? And I think Dr. Volkow wants 
in on this.
    Dr. Volkow. Yes, I was smiling because the notion is we 
have situations where a patient cannot get their medication, 
and yet at the same time, the DEA has to collect this massive 
amount of pills that people are not using, which tells you we 
are overprescribing the number of pills that are necessary.
    So coming back to the point that we have been discussing, 
we really need to educate the healthcare system on the optimal 
way of prescribing them, not just when they need them, but the 
number of tablets that you are given. I mean all of us have the 
idea, go to the dentist, 2 weeks of opioid prescriptions. I 
mean you need one day. So it is the whole notion of educating 
the healthcare system, and educating the lay public, and making 
the responsibility too of--why do we need to provide so many 
pills. And the insurers can get involved into these type of 
solutions.
    Dr. Clark. And the lock-in approach works as part of a 
treatment plan----
    Mr. Griffith. That is right.
    Dr. Clark [continuing]. With someone who suffers from 
chronic pain, the practitioner develops a treatment plan, the 
patient agrees, and that actually benefits everyone.
    Mr. Griffith. Very good.
    Mr. Burgess. The----
    Mr. Griffith. I know my time----
    Mr. Burgess. The gentleman's time has expired. We will give 
an opportunity perhaps for a second round, but I wanted to go 
to Mr. Griffith because he has been waiting so long.
    Mr, Griffith. Absolutely.
    Mr. Scalise. Thank you for that, Mr. Chairman, and for our 
panelists for this important discussion. I know in my home 
parish of Jefferson, Louisiana, we have seen spikes in increase 
of drug-related deaths over the last few years, and each year 
it just seems to be going up higher. When I talk to my coroner 
in Jefferson, Gerry Cvitanovich, who works very closely in 
trying to, of course, they see the end result of it, but they 
also try to work on the front end in doing some of the 
education that Dr. Clark has talked about and others. They have 
seen that heroin is the one that seems to be popping up the 
most. I think last year, heroin deaths accounted for a majority 
of all the drug-related deaths, over 100 of those. And in my 
home parish of Jefferson, like I said, we are seeing this 
across the board.
    One of the things they do work on is just trying to educate 
people in the community. And I know, Dr. Clark, you have talked 
about this in your testimony, and alluding to work with not 
just pharmacists but others.
    What are the different things that you have been doing, and 
if you have had success on the education front, especially not 
just within the medical community, but within the targeted 
populations of those folks that might have the highest 
likelihood of being exposed to heroin?
    Dr. Clark. Again, one of the things, a comprehensive 
strategy becomes critical, and I talked with prevention, 
working with community coalitions, so that we have that 
message. We have already heard about the issue of chronic pain 
management, and people moving from the use of a prescription 
opioid to drugs like heroin.
    So having good strategies for pain treatment, working with 
state health and territorial health officers, federation and 
state medical boards, nursing organizations, dental 
organizations and even veterinarians, because they, too, have 
access to prescription----
    Mr. Scalise. Right.
    Dr. Clark [continuing]. Opioids, we can address that end of 
the agenda, then----
    Mr. Scalise. Yes, I want Mr. Rannazzisi----
    Dr. Clark [continuing]. Probably----
    Mr. Scalise [continuing]. To answer this too because I know 
you talked about this in your testimony as well, so if you can 
touch on your experiences there.
    Mr. Rannazzisi. We never turn down the opportunity to go 
out and speak to professional organizations. We have a very 
good relationship, or a fine relationship with the National 
Association of Boards of Pharmacy, the individual pharmacist 
associations, and the medical associations. When they ask us, 
we will come out. The Pharmacist Diversion Awareness 
Conference, we go out and we have been to 14 states, and 
trained over 6,000 pharmacists in their corresponding 
responsibility, the trends and trafficking for pharmaceuticals, 
to make them aware of what is going on so they know how to deal 
with this when a bad prescription comes in and what they are 
supposed to do.
    We have industry conferences. We bring industry in. October 
of last year, we brought the distributors in to talk about what 
we are seeing trendwise, and what they need to do as far as 
their legal obligations under the Act. We bring the 
manufacturers and importers in. In April or May of last year, 
we brought them in. And we do this on a regular basis to show 
the trends and trafficking. We are out there educating as much 
as possible because it is one of the pillars in the 
pharmaceutical initiative that the White House is pushing for.
    Mr. Scalise. One of the things when you talk to the people 
on the ground, our local, whether it is coroners, law 
enforcement, there are a lot of different federal programs out 
there, and I do want to touch on that GAO report because there 
are some concerning issues that they raised that have been 
touched on a little bit, but I want to get into a little bit 
more, but on that front, when you look at all the grants that 
are out there, I know in Louisiana, I think grants come in from 
five different departments through thirty different programs 
for some of these treatment programs. So there is a lot of 
overlap and duplication, but is there a better way maybe to 
block grant these, to put them together in a way that would be 
more flexible? And maybe, Dr. Clark, you can answer, are we 
giving states enough flexibility today and with the duplication 
can we do a better job and maybe consolidating those grants in 
a way that allow the states to do what they do best, without 
having to go through so many different processes, through so 
many different agencies, where you have this duplication?
    Dr. Clark. Well, clearly, we have to work with states and 
their discretion in how to prioritize what it is that they view 
as important epidemiologically in their jurisdiction. And so we 
have supported the use of block grant funds to the discretion 
of the states, and worked with both the individual state 
authorities and the national organizations associated with 
that.
    We are also working with recovery-oriented organizations so 
that we have peers, people who are recovering from substance 
use disorders to help speak up and carry out the message, 
working with community coalitions and others because, indeed, 
they can tell a better story than professionals or regulators, 
et cetera. So----
    Mr. Scalise. OK, and----
    Dr. Clark [continuing]. The----
    Mr. Scalise [continuing]. And let me apologize, my time is 
about to go, I do want to at least ask for the record, if I can 
get this information on the GAO report, because it did 
identify, you have, what, 15 different federal agencies, 76 
different federal programs that all have abuse prevention or 
treatment programs, and they also identified overlap of 59 of 
the 76 programs. And so I think Dr. Gingrey had earlier asked 
Mr. Botticelli and Dr. Clark to talk about what your agencies 
are doing to address that overlap, those problems that were 
identified in the GAO report.
    If, Dr. Sosin, I am sorry, Dr. Volkow and Mr. Rannazzisi 
can also get me their information to--just to show what you all 
are doing to try to address the overlap problems that were 
raised in that GAO report.
    And with that, I will----
    Mr. Burgess. Well, the gentleman's time has expired. I 
think that information will be generally interesting to the 
committee, so if the committee staff will provide that 
information to the committee.
    Mr. Scalise. Would you all be OK with getting that to the 
committee? Thank you.
    Mr. Burgess. And the Chair would recognize the gentleman 
from Texas, Mr. Green, 5 minutes for your questions please.
    Mr. Green. Thank you, Mr. Chairman. And I thank the O&I 
Committee for having this hearing.
    Prescription drug abuse is a real growing and public health 
threat that must be addressed. The consequences of abuse and 
addiction to opioids such as prescription pain relievers and 
heroin has a devastating effect on our communities. We need a 
comprehensive solution that protects public health, preserves 
patient access to the needed therapies, and improved access to 
treatment.
    Last week, an article was published in the New England 
Journal of Medicine discussing the Department of Health and 
Human Services' efforts to address the prescription opioid 
overdose epidemic, including improving access to the addiction 
treatment services.
    Dr. Volkow, you were one of the authors of this article, 
and, Dr. Clark and Dr. Sosin, the heads of your respective 
agencies also authored this article. The article makes clear 
that the treatment of addiction to prescription drugs and other 
opioids with proven approaches like Methadone and other 
medication assisted therapy is of crucial importance. It 
describes the importance of the Affordable Care Act in 
increasing access to care for many Americans, including those 
who are struggling with addiction disorders.
    Dr. Volkow, can you elaborate on how the ACA builds on the 
Mental Health Parity and Addiction Equity Act, and improve on 
insurance coverage for people who are addicted to prescription 
drugs, heroin or other substances?
    Dr. Volkow. Yes, the problem is that, as I mentioned in my 
testimony, is that less than \1/3\ of patients that require, 
that could benefit from opioid medications, are getting them 
for the treatment of their addiction. And these reflect, among 
other things, the fact that many of the people that are 
addicted to drugs do not have an insurance, and rely on the 
state funding to get their treatment. And as a result of that, 
we have removed the healthcare system for a position there--
where they could not just act in preventing substance use 
disorders, but on treating them. The healthcare act, by 
providing insurance to those that currently don't have it, will 
give them the opportunity to be treated in the healthcare 
system for substance use disorders, as well as, in those 
instances where the addiction has not occurred, for the 
healthcare system to intervene in prevention. So that is why it 
is so important.
    Mr. Green. Dr. Clark, do you agree with that?
    Dr. Clark. Indeed. When people who present for treatment 
can't get treatment, are asked why they couldn't get treatment, 
the largest reason is cost and access to treatment.
    Mr. Green. OK, thank you. I understand the ACA provision 
creates an optional Medicaid state plan, benefit for states to 
establish health homes for the coordination of beneficiaries 
with chronic conditions, has also supported some states in 
their effort to address the drug abuse.
    Dr. Clark, can you elaborate on how the Health Home Program 
is beneficial in tackling the problem of abuse?
    Dr. Clark. Well, we have actually, with regard to opioids, 
we have got several jurisdictions that are looking at health 
homes as a way of dealing with opioids. So in Vermont, one 
jurisdiction, I think, Rhode Island, I will have to clarify 
that, is also taking that approach. Comprehensive services 
being offered where a person's care is adequately monitored 
offers us an opportunity to reduce some of the complexities 
associated with opioid misuse.
    Mr. Green. Thank you. It is clear from the comments the 
Affordable Care Act makes it possible for many people with 
substance use disorders, whether it is addiction to 
prescription drugs, heroin, or other substances, to access the 
treatment they so desperately need.
    Mr. Chairman, I know we have had our differences over the 
Affordable Care Act, but I would hope we all share the goal of 
providing more robust treatment to those who are working to 
overcome this addiction.
    And I yield back my time.
    Mr. Burgess [presiding]. The gentleman yields back. Our 
discussion with the Affordable Care Act will continue at a 
later date.
    Mr. Green. I am sure it will.
    Mr. Burgess. We have now I think heard from all members who 
wanted to ask a question. I would ask unanimous consent that a 
follow-up question be allowed for those of us who remain.
    Mr. Green. I don't have any problem with that. I can't 
stay, but----
    Mr. Burgess. Very well, but I wanted to get that unanimous 
consent agreed to before you left, so it is not just on my 
shoulders.
    Mr. Green. I trust the Chairman.
    Mr. Burgess. Mr. Griffith, I interrupted you before. Would 
you like to follow up on your line of questioning?
    Mr. Griffith. Well, I would just like to give an 
opportunity, Mr.----
    Mr. Rannazzisi. Rannazzisi.
    Mr. Griffith [continuing]. Rannazzisi.
    Mr. Rannazzisi. Yes.
    Mr. Griffith. Thank you. I am sorry I have such a hard time 
with that this morning. But Mr. Rannazzisi was about to comment 
on the dilemma that we have with the small rural pharmacists, 
or pharmacy, that has one distributor.
    Mr. Rannazzisi. Yes, and I want to thank you for clarifying 
that DEA has not set a quota downstream for the distributors.
    The distributors are working through their issues regarding 
due diligence to determine if there is a problem pharmacy or if 
it is not a problem pharmacy. I think that the rural pharmacies 
present a specific problem because they do need to get 
medication to their patients, and they need that downstream 
supply. We are hoping that the distributors are on site, 
looking at their operations before they completely cut off the 
distributor, or limit the pharmacy, but again, that is a 
business practice and, unfortunately, I have no control over 
their business practices.
    Mr. Griffith. Well, and I would just say it is because of 
the concerns and I am sure some memos have been put out by the 
DEA, we are all trying to do the right thing, that has caused 
the distributor to be concerned, and maybe if there could be 
some acknowledgement from the DEA to the distributors, hey, 
keep an eye out if it is rogue, but if it is just you are 
looking at, you know, this pharmacy is more than another 
pharmacy, find out if they have just one distributor because 
that makes a huge difference in whether or not they are truly 
distributing more of the opioids than somebody else. And if you 
all could do that, that would be greatly appreciated.
    Mr. Burgess. The gentleman yields back. I thank the 
gentleman for his follow-up.
    Dr. Volkow, you made a statement that was really fairly 
provocative a few moments ago, and I just wanted to follow up 
on it a little bit with you when you were discussing the effect 
of nicotine, alcohol on developing--I guess you were talking 
about developing brains and then you added the--with the 
addition of marijuana, and I ask you not to say anything about 
the rightness or wrongness of the public policy, but as you 
know, this nation is right now engaged in a significant 
experiment where some states have legalized marijuana. Are you 
all studying that and the effect of this decriminalization in 
some states? Are we prepared for what might happen next?
    Dr. Volkow. Yes, definitely. I know, unfortunately, it is 
one of those experimental situations that is happening, whether 
we like it or not. So what we have done is provided, identified 
the grantees, the researchers, in those communities where there 
has been legalization for recreational or medical purposes to 
actually give them supplemental money so that they can look at 
the consequences of these changes in policy, in the education 
of systems, in accidents, in emergency room admissions, in 
productivity in the workforce. We need to have evidence that 
can then--hopefully can guide policy, as opposed to doing 
policy in darkness on the beliefs of people, and what--since 
you brought up the issue, to one of the things that is also a 
concern as discussing the prescription, people are using 
prescriptions because they feel that are prescribed by 
physicians, they cannot be so harmful.
    The notion that marijuana has so-called medical purposes is 
also changing the perception of this drug cannot be so harmful 
if it has medicinal properties. And the whole perception of 
risk is changing, which, again, has opened the willingness of 
young people to take marijuana and to consume it regularly.
    Mr. Burgess. Well, I do hope that you are monitoring the 
situation, since society has provided you the experimental 
situation. I also hope that you are preparing to deal with what 
the downstream effects are from this rather bold social 
experiment that some of the states are undertaking right now. 
And I hope that is more than just sending more money to those 
states. I hope that it is something that you are--that 
oversight is happening at your level, that there will be a 
national monitoring of this.
    Dr. Volkow. The way that we oversee research protocol is 
very, very rigorous. If the scientist is not producing or the 
methodology is not adequate, we do not fund them.
    Mr. Burgess. Just speaking of downstream effects, there is 
also the issue, and it has been brought up several times this 
morning, and any of you feel free to comment on this, the issue 
of, of course, the device by which the drug is administered, 
and then the possibility for exposure to Hepatitis B or C, or 
HIV. From a public health perspective, are we preparing 
ourselves for any differences in the incidence of these 
illnesses as a consequence of the delivery device?
    Mr. Botticelli. I will start on that. One of the main 
concerns of HHS has been, obviously, the increase in viral 
hepatitis and hepatitis C among the very young cohort of 
injection drug users. So we have been working in concert with 
the Health and Human Services who has put forth actually an 
action plan to diminish viral hepatitis, and clearly, there is 
a lot of overlap in terms of the issues that we are talking 
about here. So this is obviously a significant public health 
concern, so we want to make sure that we are dealing with this 
in a concerted way.
    Mr. Burgess. Yes, and, of course, the good news right now 
is Hepatitis C is one of those things that looks very well like 
there may be a cure that is not just on the horizon but is 
here. The only problem is it is very expensive. And my 
differences with Mr. Green over the Affordable Care Act aside, 
ultimately though, someone has to pay for that, so I hope we 
are doing the necessary--I hope we are monitoring and doing the 
necessary preventive things to keep that in check, and to 
prevent the disease, rather than just simply now being able to 
cure it with a very expensive therapy that, thankfully, is 
available.
    Mr. Botticelli, did you have some additional observations 
on the issue of the states that are legalizing marijuana?
    Mr. Botticelli. I do, and what I wanted you to know is that 
in addition to the additional NIDA grants that are out there, 
our office has actually convened a group of Federal partners to 
look at the eight criteria that the Department of Justice has 
laid out for Colorado and Washington, and are really committed 
to gathering data on the Federal, state and local level, 
looking at what is the impact in terms of legalization in 
Colorado and Washington have on both the public health and 
public safety consequences that we have. So in addition to some 
of the public health-related work that Dr. Volkow has funded, 
we are also looking at what are the public safety consequences, 
things like increase in drugged driving, interstate 
transportation of marijuana from Colorado to other states. So 
our office has really been committed in terms of ensuring that 
we have good public health and public safety data to monitor 
what is happening in Colorado and Washington.
    Mr. Burgess. And, Mr. Rannazzisi, I would assume that your 
agency is participating in that as well?
    Mr. Rannazzisi. It still is a Schedule I controlled 
substance. We are still doing investigations concerning 
marijuana downstream.
    Mr. Burgess. And are you monitoring the downstream effects 
in neighboring states, in the incidences--as Mr. Botticelli 
talked about, the incidence of driving while impaired, the 
incidence of even just crime, are you compiling those 
statistics so they will be available to policymakers in 
subsequent hearings?
    Mr. Rannazzisi. We are talking to our state and local 
counterparts in all of the surrounding states, and we are 
gathering information. I don't know how all-inclusive that 
information is because, quite frankly--some of the state and 
locals are not keeping that type of information, but we are 
keeping tabs with our state and locals on what is going on 
within their states.
    Mr. Burgess. Very well.
    Mr. Griffith. Mr. Chairman.
    Mr. Burgess. Yes, the Chair recognizes the gentleman from 
Virginia.
    Mr. Griffith. I would be remiss, since we have taken on 
marijuana, not to mention that I have just introduced a Bill to 
legalize the use of marijuana in medicinal circumstances, akin 
to the Virginia plan that was passed in 1979, that requires a 
doctor's prescription, thus, changing the scheduling. The Bill 
actually calls for the changing of the scheduling. The DEA is 
in a tough spot. Some of these states are doing it, but it is 
still a Schedule I, which means that the DEA has a hard time 
collecting the data that you just asked for without stumbling 
across felons that they are not prosecuting. So they are in a 
catch 22. I think it is much better to have doctors and 
pharmacists, and the regular system working, because then you 
get real data for your scientists to look at and see if it is 
effective, as they designed it to be.
    So the Bill doesn't go as far as Colorado or Washington 
might want it, or the Crazy California Plan as I often call it, 
but it allows real doctors with real pharmacists and real 
distributors, controlled by and under the laws of the United 
States, to use true marijuana if it can be used in a real way 
medicinally.
    Mr. Burgess. Very good. The gentleman yields back.
    I am all for giving doctors more power.
    That actually concludes all of the questions that we have 
from members. I neglected to mention at the start of the 
hearing, ask unanimous consent that members' written opening 
statements be introduced into the record. Without objection, 
the documents will be entered into the record.
    In conclusion, I would like to thank all of our witnesses. 
I will thank the member that have participated in today's 
hearing. I will remind members they have 10 business days to 
submit questions for the record, and I will ask the witnesses 
to all agree to respond promptly to the questions submitted in 
writing.
    With that, the subcommittee is adjourned. Thank you for 
your attendance today.
    [Whereupon, at 12:06 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                 Prepared statement of Hon. Tim Murphy

    Three months ago, the country was shocked and saddened by 
the death of actor Philip Seymour Hoffman. Like many who battle 
addiction, Mr. Hoffman struggled to stay clean as he alternated 
between pain pills and heroin. His story is far too common. 
Opiate addiction surrounds us--from cities, rural towns, and 
affluent suburbs--and it breaks our heart to see so many 
families torn apart by abuse of drugs that are both legal and 
illegal.
    My own district has suffered terribly from opiate 
overdoses. Last year, more than 90 people in Westmoreland 
County lost their lives to prescription drug and heroin abuse. 
That was four times the number of overdose deaths in the county 
compared to a decade ago. Allegheny County saw more than 20 
deaths linked to fentanyl-laced heroin this past January.
    Heroin-related deaths have increased 400 percent in 
Cleveland. Vermont Governor Peter Shumlin dedicated his entire 
annual ``State of the State'' address to what he called the 
``fullblown heroin crisis'' facing his state. Kentucky, West 
Virginia, New Mexico, and other states are also experiencing 
rising rates of prescription drug overdoses and heroin abuse.
    Here's the awful truth about this public health crisis: 
prescription painkillers are involved in more overdose deaths 
than cocaine and heroin combined. Prescription drug abuse kills 
more than 16,000 people a year.
    While most prescription drug abusers do not go on to abuse 
heroin, data from the White House Office of National Drug 
Control Policy (ONDCP) and the Substance Abuse and Mental 
Health Services Administration (SAMHSA) indicates that 81 
percent of people who started using heroin in 2008 to 2010 had 
previously abused prescription drugs.
    As authorities have cracked down on access to legal pain 
killers in the last five years, heroin use has risen by an 
astonishing 79 percent.
    Certainly, there is a law enforcement aspect to solving 
this problem and stopping the bad actors who illegally 
distribute prescription drugs or traffic heroin. But the other 
part of the equation is treating addiction to prescription 
drugs and heroin--and preventing deaths.
    The purpose of today's hearing is to examine the federal 
public health response to prescription drug and heroin abuse. 
Our oversight has revealed that this is a complex problem. For 
example, 40 percent of those who abuse drugs have an underlying 
mental illness. Treating their addiction successfully 
necessarily means that the underlying mental illness must be 
successfully diagnosed and treated.
    But just as when someone has a mental illness, those who 
are battling addiction are unlikely to get effective treatment, 
too. More than 90 percent of persons with a substance abuse 
disorder won't get medical care. And of those who are enough to 
access care, 90 percent of them will not get evidence-based 
treatment.
    There are effective treatments available, but too often the 
substance abuse debate is divided between those who adhere to 
the abstinence or 12-step model, and those who promote medical 
assistance therapies. These groups must come together and find 
a solution because thousands of lives are at stake.
    As the testimony of Mr. Botticelli, the Acting Director of 
the Office of National Drug Control Policy, states, substance 
abuse is a ``progressive disease.'' Those who suffer from 
addiction often start at a young age, with alcohol and 
marijuana, and then move to other drugs like opioids. In 
examining opioid abuse, we must also consider the factors that 
lead people to abuse--and how federal programs are addressing 
them.
    Prescribing practices are an issue. Roughly 20% of 
prescribers prescribe 80% of all prescription painkillers. 
Those suffering from chronic and debilitating pain need access 
to opiates, but we also need to make sure those individuals who 
develop an addiction are referred to treatment. Right now, too 
many states lack a robust prescription drug monitoring program 
that would help physicians and emergency rooms keep tabs on 
patients receiving powerful opiates.
    Educating doctors and pharmacies about appropriate 
prescribing will address one part of the problem--but addicts 
also get these drugs through illegal channels, such as rogue 
Internet pharmacies, off the street, and even from the medicine 
cabinets of family members and friends.
    The federal government is devoting significant resources to 
drug control programs--over $25 billion annually, of which 
about $10 billion goes toward drug abuse prevention and 
treatment programs across 19 federal agencies. With 19 agencies 
having a hand in over 70 drug control programs, we have to ask, 
`is our current approach working and what can we do better?' 
Oversight by the federal agencies is also an important issue, 
as significant funding is block granted to states for treatment 
programs. How are you confident that we are funding treatments 
with the best chances of success in preventing and treating 
opiate abuse?
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