[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
WHAT IS THE FEDERAL GOVERNMENT DOING TO COMBAT THE OPIOID ABUSE
EPIDEMIC?
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
__________
MAY 1, 2015
__________
Serial No. 114-38
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
_____________
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Chairman Emeritus Ranking Member
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania ELIOT L. ENGEL, New York
GREG WALDEN, Oregon GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington KATHY CASTOR, Florida
GREGG HARPER, Mississippi JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky PETER WELCH, Vermont
PETE OLSON, Texas BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia PAUL TONKO, New York
MIKE POMPEO, Kansas JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida KURT SCHRADER, Oregon
BILL JOHNSON, Ohio JOSEPH P. KENNEDY, III,
BILLY LONG, Missouri Massachusetts
RENEE L. ELLMERS, North Carolina TONY CARDENAS, California
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota
7_____
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
DAVID B. McKINLEY, West Virginia DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
LARRY BUCSHON, Indiana JOHN A. YARMUTH, Kentucky
BILL FLORES, Texas YVETTE D. CLARKE, New York
SUSAN W. BROOKS, Indiana JOSEPH P. KENNEDY, III,
MARKWAYNE MULLIN, Oklahoma Massachusetts
RICHARD HUDSON, North Carolina GENE GREEN, Texas
CHRIS COLLINS, New York PETER WELCH, Vermont
KEVIN CRAMER, North Dakota FRANK PALLONE, Jr., New Jersey (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
----------
Page
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 5
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 7
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, prepared statement........................ 8
Witnesses
Michael P. Botticelli, Director, Office of National Drug Control
Policy......................................................... 10
Prepared statement........................................... 13
Answers to submitted questions............................... 138
Richard G. Frank, Ph.D., Assistant Secretary for Planning and
Evaluation, Department of Health and Human Services............ 29
Prepared statement........................................... 31
Answers to submitted questions............................... 144
Nora D. Volkow, M.D., Director, National Institute on Drug Abuse,
National Institutes of Health.................................. 41
Prepared statement........................................... 43
Answers to submitted questions............................... 150
Douglas C. Throckmorton, M.D., Deputy Director, Center for Drug
Evaluation and Research, Food and Drug Administration.......... 56
Prepared statement........................................... 58
Answers to submitted questions............................... 159
Debra Houry, M.D., M.P.H., Director, National Center for Injury
Prevention and Control, Centers for Disease Control and
Prevention..................................................... 71
Prepared statement........................................... 73
Answers to submitted questions............................... 164
Pamela S. Hyde, J.D., Administrator, Substance Abuse and Mental
Health Services Administration................................. 81
Prepared statement........................................... 83
Answers to submitted questions............................... 170
Patrick Conway, M.D., M.S., Deputy Administrator for Innovation
and Quality, and Chief Medical Officer, Centers for Medicare
and Medicaid Services.......................................... 92
Prepared statement........................................... 94
Answers to submitted questions............................... 178
Submitted Material
Subcommittee memorandum.......................................... 125
Article of April 30, 2015, ``Physician-Issued Opioids Associated
With Higher ED Use,'' by Alicia Ault, MedScape, submitted by
Mr. Murphy..................................................... 136
WHAT IS THE FEDERAL GOVERNMENT DOING TO COMBAT THE OPIOID ABUSE
EPIDEMIC?
----------
FRIDAY, MAY 1, 2015
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 9:00 a.m., in
room 2322, Rayburn House Office Building, Hon. Tim Murphy
(chairman of the subcommittee) presiding.
Members present: Representatives Murphy, McKinley, Burgess,
Griffith, Bucshon, Flores, Brooks, Mullin, Collins, Upton (ex
officio), DeGette, Schakowsky, Tonko, Clarke, Kennedy, Green,
and Pallone (ex officio).
Staff present: Noelle Clemente, Press Secretary; Jessica
Donlon, Counsel, Oversight and Investigations; Brittany Havens,
Oversight Associate, Oversight and Investigations; Charles
Ingebretson, Chief Counsel, Oversight and Investigations; Alan
Slobodin, Deputy Chief Counsel, Oversight; Sam Spector,
Counsel, Oversight; Christopher Knauer, Democratic Oversight
Staff Director; and Una Lee, Democratic Chief Oversight
Counsel.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Well, good morning. Welcome here to the
Oversight and Investigations Subcommittee hearing.
I just want to say it's Mental Health Month, so it's
fitting that we are here today on this issue. This is the third
in a series of hearings examining the growing problem of
prescription drugs and heroin addiction that is ravaging our
country. This is our Nation's single biggest public health
concern.
Over the past 5 weeks, this subcommittee has heard from
addiction experts working with local communities and our
leading academic and research centers. Dr. Robert DuPont, the
former White House Chief of Drug Control Policy and the first
director of the National Institute on Drug Abuse, testified
that Federal programs lack direction and standards on treating
addiction as a chronic condition, and noted what is being done
to follow up with patients to prevent relapses and put them on
a path of real recovery? He challenged us to even ask the most
fundamental question, ``What is recovery?''
Dr. Anna Lembke of Stanford Medical School provided
critical testimony on how we must revise our healthcare quality
measures to reduce overprescribing, reform medical privacy
regulations, and incentivize the use of prescription drug
monitoring programs.
We know that those with opiate addiction disorders need a
broad range of treatment options and that many with substance
abuse disorders have co-occurring psychiatric disorders, but we
need to tear down Federal policy and funding barriers that keep
us from treating both simultaneously.
About 3 weeks ago, one of today's witnesses, Mr. Michael
Botticelli, the Director of the Office of National Drug Control
Policy, presented a slide--I'm going to show it here--at the
National Rx Summit on major causes of death from injury from
1999 to 2013. Quite a revealing slide. While the trends of
other major causes of death, such as auto accidents went down,
drug poisoning continued to go up 21 percent from 2008 till
2013. In many States, these numbers are soaring at high double-
digit rate increases. As Mr. Botticelli has indicated to me
privately and at the Rx Summit, we must do better, and we have
much work to do.
Today, we will hear from Federal agencies charged with
providing guidance, direction, and leadership in our Nation's
public health response to the opiate epidemic. No Federal
agency is more central in this ongoing epidemic than the
Department of Health and Human Services or HHS. HHS and its
Substance Abuse and Mental Health Services Administration, also
known as SAMHSA, are responsible for leading our Nation's
public health response to the opiate heroin abuse and addiction
crisis.
SAMHSA regulates our country's 1,300 opiate treatment
programs, and SAMHSA is responsible for certifying the 26,000
physicians who prescribe the most commonlyused opiate
maintenance medication, buprenorphine. According to testimony
provided by SAMHSA before this subcommittee in April of last
year, there were nearly 1.5 million people treated with these
opiate maintenance medications in 2012, which is a fivefold
increase in the last 10 years.
Has SAMHSA defined the goal of recovery for what these
federally subsidized treatment programs are supposed to
accomplish? Is SAMHSA collecting and evaluating meaningful data
at an individualized level that would hold grant recipients
individually accountable for effective results? So far,
preliminary examination indicates the answers are no. And when
you don't define where you're going, every road you take still
leaves you lost. So we're hoping we can get some direction
today.
The numbers indicate we are failing as a Nation, and we
darn well better come to terms with that. The 43,000 lives lost
last year, the thousands of babies born addicted to opiates
tell us the terrible toll this epidemic has taken. You've heard
my thoughts about the Government-sponsored promotion of what
I've characterized as addiction maintenance, and I refer to
buprenorphine as heroin helper, not because the medication is
altogether lacking, because it is helpful, but rather, because
infrastructure the Federal Government has created for the use
of this highly potent and important medication is not fully
working and, worse yet, in many cases, contributing to the
growing problem. This has to be fixed, and I hope we'll find
some solutions, and that is what we need to discuss today
openly, honestly, and humbly.
If we do not reverse the current trend, where is this going
to end? How many millions of citizens do we want to have on
opiate maintenance? How many more must die? And how many more
lives and dreams must be shattered before we recognize the
depth of this national scourge?
Now, I don't believe in better living through dependency.
And, again, please do not misconstrue this critique as a
general indictment of opiate maintenance. It is not. For some
people, opiate maintenance is the most appropriate bridge
treatment, and there should be no shame or stigma associated
with it. But opiate maintenance therapy should not be the only
treatment offered to the opiate-dependent individuals, and it
is not the only goal.
What patients on opiate maintenance can be successfully
transition off of these medications? What protocols are best
for affecting this transition? What are the best practice for
prevention of relapse for those patients who end opiate
maintenance treatment? There are nonaddictive medications
approved for this use, but are these medications widely
available and how well do they work?
The diversion of buprenorphine for illicit nonmedical use
is a related problem, because this is how the opiate epidemic
can be spread. According to the DEA, buprenorphine is the third
most often seized prescription opiate by law enforcement today.
Where is a call to modernize our existing opiate addiction
treatment system to ensure that the right patient gets the
right treatment at the right time? Why aren't we hearing about
expanding access to nonaddictive narcotic treatments that have
zero potential for abuse or diversion, such as Naltrexone and
evidence-based counseling? These are all incredibly important
tools, and we want to make sure HHS talks more about these.
Last week, Dr. Westley Clark, the former Director of SAMHSA
Center for Substance Abuse treatment and the man who oversaw
the growth of buprenorphine over the past decade declared
before the American Society of Addiction Medicine that many
buprenorphine practices have become pill mills where doctors
and dealers were increasingly indistinguishable and physician
negligence and alleged laboratory fraud prevailed. The problem
is not with buprenorphine, however. The problem lies with
current practices, and this is what we need to discuss.
I consider opiate maintenance as a bridge for those with
addiction disorders to cross over in the recovery process. And
as I said, it is not a final destination. We seek to lay out a
vision for recovery that includes complete withdrawal from
opiates as an option. For cancer, for diabetes, for AIDS, we
want people to be free of the diseases, not just learn to live
with it. We need to commit the same sorts of things through our
research and clinical efforts that boldly declare what we must
change here.
I thank our witnesses for being here today.
[The prepared statement of Mr. Murphy follows:]
Prepared statement of Hon. Tim Murphy
Today we convene the third in a series of hearings
examining the growing problem of prescription drugs and heroin
addiction that is ravaging our country. This is our Nation's
single biggest public health concern.
Over the past five weeks, this subcommittee has heard from
addiction experts working within local communities and our
leading academic and research centers.
Dr. Robert DuPont, the former White House Chief on drug
control policy and the first director of the National Institute
on Drug Abuse, testified that Federal programs lack directions
and standards on treating addiction as a chronic condition and
noted: What is being done to follow-up with patients to prevent
relapses and put them on a path of real recovery? He challenged
us to even ask the most fundamental question: what is recovery?
Dr. Anna Lembke of Stanford Medical School provided critical
testimony on how we must revise our healthcare quality measures
to reduce over-prescribing, reform medical privacy regulations,
and incentivize use of Prescription Drug Monitoring Programs.
We know that those with opioid-addiction disorders need a broad
range of treatment options, and that many with substance abuse
disorders have a co-occurring psychiatric disorder--but we need
to tear down Federal policy and funding barriers that keep us
from treating both simultaneously.
About three weeks ago, one of today's witnesses--Mr.
Michael Botticelli, the Director of the Office of National Drug
Control Policy--presented the following slide at the National
Rx Summit on major causes of death from injury 1999-2013. While
the trends of other major causes of death such as auto
accidents went down, drug poisoning continued to go up 21
percent from 2008 to 2013. In many States these numbers are
soaring at high double digit rates of increase. As Mr.
Botticelli has indicated to me privately and at the Rx Summit,
we must do better and we have much work to do.
Today, hear from the Federal agencies charged with
providing guidance, direction, and leadership in our Nation's
public health response to the opioid epidemic.
No Federal agency has a more central role in this ongoing
epidemic than the Department of Health and Human Services
(HHS). HHS and its Substance Abuse and Mental Health Services
Administration (SAMHSA) are responsible for leading our
Nation's public health response to the opioid, heroin abuse and
addiction crisis. SAMHSA regulates our country's 1,300 opioid
treatment programs, and SAMHSA is responsible for certifying
the 26,000 physicians who prescribe the most commonly used
opioid maintenance medication: buprenorphine. According to
testimony provided by SAMHSA before this subcommittee in April
of last year, there were nearly 1.5 million people treated with
these opioid maintenance medications in 2012--which is a 5-fold
increase in the last 10 years. Has SAMHSA defined the goal of
recovery for what these federally subsidized treatment programs
are supposed to accomplish? Is SAMHSA collecting and evaluating
meaningful data at an individualized level that would hold
grant recipients individually accountable for effective
results? So far, our preliminary examination indicates the
answers are no. And when you don't define where you are going,
every road you take still leaves you lost.
The numbers indicate we are failing as a nation, and we
darn well better come to terms with that. The43,000 lives lost
last year, the thousands of babies born addicted to opioids
tell us the terrible toll thisepidemic has taken.You have heard
my thoughts about the Government-sponsored promotion of what I
have characterized as''addiction maintenance.''
I have referred to buprenorphine as a ``heroin helper'' not
because the medication is altogether lacking,but rather,
because the infrastructure the Federal Government has created
for the use of this highly potentand important medication is
not working and worse yet, contributing to the growing problem.
It has to befixed, and that is what we need to discuss--
honestly, openly, humbly.
If we do not reverse the current trend, where will it end?
How many millions of citizens do we want tohave on opioid
maintenance? How many more must die? How many more lives and
dreams must beshattered before we recognize the depth of this
scourge?
I do not agree in ``better living through dependency.''
Again, please do not misconstrue this critique as a general
indictment of opioid maintenance. It isnot. For some people,
opioid maintenance is the most appropriate bridge treatment and
there should be no shame or stigma associated with it. But
opioid maintenance therapy should not be the only treatment
offered to opioid dependent individuals, nor the only goal.
What patients on opioid maintenance can be successfully
transitioned off of these medications? What protocols are best
for effecting this transition?
What are the best practices for the prevention of relapse
for those patients who end opioid maintenance treatment? There
are non-addictive medications approved for this use, but are
these medications widely available?
The diversion of buprenorphine for illicit, non-medical use
is a related problem because this is how the opioid epidemic
can be spread. According to the DEA, buprenorphine is the third
most often seized prescription opioid by law enforcement today.
Where is the call to modernize our existing opioid
addiction treatment system to ensure that the right patient
gets the right treatment at the right time? Why aren't we
hearing about expanding access to nonaddictive, non-narcotic
treatments that have zero potential for abuse or diversion,
such as naltrexone and evidence-based counseling? These are
incredibly important tools that are barely mentioned in the HHS
plan.
Last week, Dr. Westley Clark, the former Director of
SAMHSA's Center for Substance Abuse Treatment, and the man who
oversaw the growth of buprenorphine over the past decade,
declared before the American Society of Addiction Medicine that
many buprenorphine practices had become pill mills where
``Doctors and Dealers'' were increasingly indistinguishable and
``Physician Negligence'' and ``Alleged Laboratory Fraud''
prevailed. The problem is not with buprenorphine, however. The
problem lies with current practice and this is what we need to
discuss.
I consider opioid maintenance as a bridge for those with
addiction disorders to cross over in the recovery process. It
is not a final destination. I seek to lay out a vision for
recovery that includes complete withdrawal from opioids as an
option. For cancer, diabetes, AIDS, we want people to be free
of the disease, not learn to just live with it. We need to
commit to research and clinical efforts that boldly declare
that we must change.
Mr. Murphy. And I now recognize the ranking member of the
subcommittee, Ms. DeGette from Colorado, for 5 minutes.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you so much, Mr. Chairman.
I think it's really important to hear from our witnesses
today about the work the Federal Government is doing to address
this serious public health issue, and I know all of the
agencies represented before us do critical work to prevent and
treat this epidemic.
In March, Secretary Burwell announced an initiative to
combat the opioid crisis. I applaud the Department's actions,
and I'm gratified to hear that this is one of the Secretary's
top priorities. I want to hear more about this initiative today
and how all the agencies before us are working together to
accomplish its goals. But at the same time, I have some hard
questions about our approach to caring for those who have
substance abuse disorders.
Last week, we heard from a panel of medical experts who
have vast experience in treating opioid addiction.
Unfortunately, as the chairman said, they gave us a fairly
bleak view of the opioid treatment landscape in this country.
For example, one witness, Dr. Adam Bisaga, a psychiatrist at
Columbia University and a research scientist at the New York
State Psychiatric Institute, told the committee that the
majority of patients being treated for opioid addiction
received treatment that is both, ``outdated'' and ``mostly
ineffective.'' He described this approach of rapid
detoxification, followed by an abstinence-only method without
the use of important treatment medications. Dr. Bisaga added
that this is potentially dangerous because it raises the risk
of an overdose if a patient relapses.
As troubling as this testimony from our last hearing was,
today we have Dr. Volkow on our panel, who is one of the
world's top experts on addiction research. And she notes--I'm
sure you'll talk more about this, Doctor--in her written
testimony that, ``Existing evidence-based prevention and
treatment strategies are highly underutilized across the United
States.''
Why is that, Mr. Chairman? Why do we have experts week
after week telling us that the bulk of the treatment Americans
are receiving for this devastating disease are ineffective,
outdated, and not evidence based.
We need to be asking ourselves some tough questions. For
example, Dr. Westreich, the president of the American Academy
of Addiction Psychiatry, told us last week, ``Patients and
their families need to know that detoxification treatment and
drug-free counseling are associated with a very high risk of
relapse.'' Are patients enrolling in treatment getting
sufficient data so they can make medically informed choices?
Are families and loved ones being told what approaches have
high failure rates before choosing an approach to treatment?
Frankly, this is not a decision that should be taken lightly.
Getting ineffective treatment may not only be financially
costly, but it may result in a fatal relapse.
Finally, Mr. Chairman, recent testimony, including some I
saw in the written statements for today, raises important
questions about whether taxpayer dollars should fund certain
approaches for combating this opioid epidemic over others. This
is an issue I've been talking about week after week. We all
agree that we need the most effective treatment, and our
experts agree that this treatment needs to be a broad menu of
options that is different from patient to patient.
So we might not have a silver bullet to cure opioid
addiction at this point, but we do know what treatments work
better than others. Evidence tells us--and all the medical
experts we heard from last week agree--that for most patients a
combination of medication-assisted treatment and behavioral
treatment, such as counseling and other supportive services, is
the most effective way to treat opioid addiction. If that's the
case, we should pursue more policies that encourage this
approach as a clear option and steer away from any efforts that
are not evidence based. It's costly, and it's dangerous to the
patient.
So I hope we can all work together to fight this epidemic,
and I do look forward to hearing from all of our witnesses. I'm
glad Secretary Burwell and the department are devoting serious
attention to addressing both the prevention and treatment sides
of this problem.
And, Mr. Chairman, this has been a really great series. I'm
happy to have a whole investigation like this in this
committee. There's one group that we haven't heard from yet,
I'm hoping----
Mr. Murphy. States.
Ms. DeGette. Good. The States. We haven't heard from the
States yet. It's critical we hear from them because that's
where the rubber is hitting the road. We need to hear what the
States are doing to address this problem and understand the
reasoning behind some of the choices being made. Some States
are picking effective treatment methods, and others are not.
So I think we need a multifaceted approach that this is
what our research has showed, and I know we can work together
to continue this important investigation.
I just want to add one more note. The witnesses and the
audience may see members jumping in and running out. We have
another hearing in Energy and Commerce Committee going on down
on the first floor, so people will be coming and going. But I
know certainly, from my side of the aisle, people recognize
this is a very serious issue. Thank you.
Mr. Murphy. Thank you. And I know that they'll be calling
votes at 9:30 for first vote series.
Ms. DeGette. I thought it was at 11:00
Mr. Murphy. Something has changed. First and only vote
series of the day. I'm here for the duration, so we want to
hear from you and hopefully the members.
And now we recognize Mr. Upton.
Mr. Upton. We really are going to have votes at 9:30?
Mr. Murphy. That's what it says now.
Mr. Upton. Well, I'm going to submit my statement for the
record then.
Mr. Murphy. OK. All right.
[The prepared statement of Mr. Upton follows:]
Prepared statement of Hon. Fred Upton
Today we continue our important review of the opioid abuse
epidemic. In recent weeks we have heard valuable testimony from
academics and State and local leaders, including folks on the
frontlines in Southwest Michigan, and today we will hear what
the Federal Government is doing to combat this pressing issue.
The abuse of painkilling opioids and heroin is a complex
and growing public health crisis that has sadly been outpacing
the Nation's efforts to reverse this epidemic. A lot of people
are dying, and a lot of families are suffering. In Kalamazoo
County, where the reality of heroin overdoses has hit hard, we
remember two young women who were friends. In 2008, we lost Amy
Bousfield at 18 years old. In 2012, her friend Marissa King
died at 21 years old. Marissa began using heroin in 2009,
despite having lost two friends to the drug. Marissa was
diagnosed with bipolar disorder, had struggled with depression,
and had abused prescription drugs before turning to heroin
after graduating from high school.
Every community has been hit by heartbreak. According to
the Michigan Department of Community Health, ``Unintentional
poisoning deaths in Michigan involving opioids comprise 20
percent of unintentional poisoning deals in 2012, compared to
11 percent in 1999. Unintentional poisoning deaths involving
opioids increased more rapidly than those from any other
drug.'' This subcommittee's diligent review of every
perspective of this issue is important.
Last week, we took an important step. The House approved
bipartisan legislation coauthored by the full committee Vice
Chairman Marsha Blackburn, and Representatives Tom Marino,
Peter Welch, and Judy Chu to clarify language in the Controlled
Substances Act and promote collaboration between agencies and
stakeholders to ensure patients have access to medications.
But this subcommittee's hearings have shined a light on how
much more needs to be done. Our review has introduced us to
many health professionals, scientists, community leaders, and
public servants who are working their hearts out to make a
difference and to help reduce this problem. There are a number
of worthy ideas on how to strengthen the Federal response.
To take on the enormous challenge posed by the opioid abuse
epidemic, we need to be unified and find common ground. These
hearings provide a foundation for this committee to proceed in
a bipartisan fashion to take constructive and effective
actions. I am ready to work with my colleagues on the committee
on both sides of the aisle, the president, Secretary Burwell,
and the rest of the administration to produce positive results
in fighting this epidemic for the American people.
We want to help. I welcome our distinguished Federal
Government witnesses and look forward to their testimony.
Mr. Upton. Yield back.
Mr. Murphy. All right.
Mr. Pallone, 5 minutes.
Mr. Pallone. I'll do the same, Mr. Chairman, because we
both have to go to the other hearing.
Mr. Murphy. OK.
Mr. Upton. It's his bill. It's his bill we're talking
about.
Mr. Murphy. See how much we get along?
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Mr. Chairman, thank you for holding this hearing today--the
third in a series on the opioid abuse epidemic. This problem
has affected every one of our districts, and I am glad this
subcommittee is taking a serious look at this issue.
Today's hearing gives us the opportunity to hear from
Federal Government agencies about what they are doing to tackle
the opioid addiction crisis. I am pleased to see that Secretary
Burwell and the Department are taking important steps on both
the prevention and the treatment of opioid abuse and I look
forward to working with them on addressing this burgeoning
crisis. To that end, it is critical also that we approach this
problem on both sides of this issue--upstream, where
overprescribing is occurring, and downstream, where better
treatment across this country is desperately needed.
The opioid addiction and abuse epidemic is inextricably
tied to the overprescribing of these drugs for the treatment
and management of chronic pain. I want to hear from you about
how we can reduce the overprescribing of opioids and assist
medical professionals in making informed prescribing decisions.
On the treatment side, we need to focus our attention on
what works. There is consensus in the medical community that
medication-assisted treatment--or MAT--is an essential
component of effective treatment. However, it is still not
available in large parts of the country and as others have
already told this committee, many Americans are receiving
outdated and ineffective treatment. We need to understand why
that is the case and how we can increase access to the most
effective treatment protocols currently available.
I also want to use today's hearing as an opportunity to
hear from these Federal agencies about the implementation of
the Affordable Care Act. When we passed the law, we took
significant steps to expand access to health care for all
Americans, including those with substance use disorders.
For many, the lack of insurance or the cost of treatment
presents an insurmountable barrier to receiving the treatment
help they need. The Affordable Care Act addresses some of these
problems by expanding insurance coverage and requiring that
insurance cover the cost of substance abuse services. This will
mean that millions of people will have access to the tools they
need to break their addictions.
Additionally, the Affordable Care Act provides us with a
historic opportunity to transform a fragmented, underfunded
system for treatinu substance abuse disorders into one that
promotes coordinated, patient-centered care. I look forward to
hearing from Dr. Frank and others about how the Affordable Care
Act is transforming the landscape for behavioral health
services, and what more needs to be done to truly inteurate
behavioral health services into our broader healthcare system.
Thank you again for holding this important hearing and to
all our witnesses. I look forward to continuing our work on
this issue.
I yield my remaining time to Rep. Kennedy.
Mr. Murphy. Is there anybody else on either side that needs
recognition? Go right into this.
OK. Let me find my----
Ms. DeGette. No. Wait, wait. Mr. Kennedy.
Mr. Pallone. Oh, he wanted a minute. Mr. Chairman, can I
yield just 1 minute to Mr. Kennedy?
Mr. Murphy. Yes. You can yield your minutes to Mr. Kennedy
of Massachusetts.
Mr. Kennedy. Thank you very much for the consideration. I
yield back.
Mr. Murphy. OK. All right. Let me now introduce the
witnesses on the panel for today's hearing. We have the
Honorable Michael Botticelli, the Director of the Office of
National Drug Control Policy, which is part of the Executive
Office of the President. Welcome here. Dr. Richard Frank, the
Assistant Secretary For Planning and Evaluation at the U.S.
Department of Health and Human Services; Dr. Nora Volkow, who
is the Director of the National Institute on Drug Abuse with
the National Institutes of Health; Dr. Douglas Throckmorton,
who is the Deputy Director of the Center for Drug Evaluation
and Research of the Food and Drug Administration; Dr. Debra
Houry, the Director of the National Center for Injury
Prevention and Control of the Centers for Disease Control and
Prevention; the Honorable Pamela Hyde, the Administrator for
the Substance Abuse and Mental Health Services Administration;
and Dr. Patrick Conway, the Deputy Administrator for Innovation
and Quality and the CMS Chief Medical Officer at the Centers
for Medicare and Medicaid Services. Welcome.
You are aware that--now swearing in the witnesses--the
committee is holding an investigative hearing and, when doing
so, has a practice of taking testimony under oath. Do you have
any objection to testifying under oath?
None of the witnesses have objection. So the Chair then
advise you that under the rules of the House and the rules of
the committee, you are entitled to be advised by counsel. Do
any of you desire to be advised by counsel today? And none of
the witnesses say so.
So, in that case, please rise. Raise your right hand. I'll
swear you in.
Do you swear that the testimony you're about to give is the
truth, the whole truth, and nothing but the truth?
Thank you. All the witnesses answered in the affirmative,
so you are now under oath and subject to the penalties set
forth in title 18, section 1001 of the United States Code.
You may now each give a 5-minute opening statement. Please
stick to the 5 minutes. If you don't have to fill it, that's
OK, too. We'd like to get through.
Mr. Botticelli.
STATEMENTS OF MICHAEL P. BOTTICELLI, DIRECTOR, OFFICE OF
NATIONAL DRUG CONTROL POLICY; RICHARD G. FRANK, PH.D.,
ASSISTANT SECRETARY FOR PLANNING AND EVALUATION, DEPARTMENT OF
HEALTH AND HUMAN SERVICES; NORA D. VOLKOW, M.D., DIRECTOR,
NATIONAL INSTITUTE ON DRUG ABUSE, NATIONAL INSTITUTES OF
HEALTH; DOUGLAS C. THROCKMORTON, M.D., DEPUTY DIRECTOR, CENTER
FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION;
DEBRA HOURY, M.D., M.P.H., DIRECTOR, NATIONAL CENTER FOR INJURY
PREVENTION AND CONTROL, CENTERS FOR DISEASE CONTROL AND
PREVENTION; PAMELA S. HYDE, J.D., ADMINISTRATOR, SUBSTANCE
ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION; AND PATRICK
CONWAY, M.D., M.SC., DEPUTY ADMINISTRATOR FOR INNOVATION AND
QUALITY, AND CHIEF MEDICAL OFFICER, CENTERS FOR MEDICARE AND
MEDICAID SERVICES
STATEMENT OF MICHAEL P. BOTTICELLI
Mr. Botticelli. Thank you, Chairman Murphy, Ranking Member
DeGette, and members of the subcommittee for the opportunity to
provide testimony to you today about the administration's
efforts to address the opioid epidemic in the United States.
Mr. Chairman, as you recognized, in 2013 almost 44,000
Americans died of a drug overdose. That's one drug overdose
death every 12 minutes. Using ONDCP's role as the coordinator
of the Federal Drug Control agencies, in 2011, we published the
administration's Prescription Drug Abuse Prevention Plan to
address the sharp rise in prescription opioid drug abuse in
this country since 1999. As you know, the plan consists of
action items categorized under four pillars: Education of
patients and prescribers; increased prescription drug
monitoring; proper medication disposal; and informed law
enforcement.
With the work of our HHS partners here today, and other
Federal partners as part of the Interagency Prescription Drug
Work Group convened by ONDCP, we have made some strides in each
of these areas, but there is much more to be done.
Since time in graduate medical education programs devoted
to the identification of treatment of substance abuse disorders
is rare, we have worked with our Federal partners to develop
continuing education programs about substance abuse, managing
pain appropriately, and treating patients using opioids more
safely. Many prescribers in Federal agencies, including HHS,
are receiving this important training. Despite this, a large
percentage of prescribers have not availed themselves of this
training. Therefore, the administration continues to press for
mandatory prescriber education tied to controlled substance
licensure. I am pleased that Secretary Burwell has expressed
her support for working with Congress to set requirements for
specific training for opioid prescribers.
Today, all States but one, Missouri, have prescription drug
monitoring programs that allow prescribers to check on drug
interactions as well as alert them to the signs of dependence
on opioids. Missouri is also working to authorize a PDMP
program. With almost all States implementing PDMPs, we are
focusing on improving State-to-State data sharing, and
improving access to PDMP data within the health record systems
providers use every day.
In October, the Drug Enforcement Administration's final
regulation on controlled substances disposal became effective.
ONDCP and our Federal partners and stakeholders have begun to
inform the public about these regulations and look to ways to
stimulate more local disposal programs in partnerships with
pharmacies, local government, community groups, and local law
enforcement.
And the work of our law enforcement partners at the
Federal, State, and local levels is ongoing. Those engaged in
fraud across the drug control supply chain are being
investigated and prosecuted.
Recent data shows we are seeing an overdose from
prescription opioids leveling off in this country, but a
dramatic 39 percent increase in heroin overdoses from 2012 to
2013. This is creating an additional need for treatment in a
system where a well-known gap between treatment capacity and
demand already exists. Therefore, we must redouble our efforts
to address people who are misusing prescription opioids, since
we know this is a major risk factor for subsequent heroin use.
Earlier this week, the administration held the inaugural
meeting of the congressionally mandated interagency Heroin Task
Force. Mary Lou Leary, our Deputy Director for State, Local,
and Tribal Affairs, is one the cochairs for this committee. In
addition, the President's FY '16 budget request includes $99
million in additional funding for treatment and overdose
prevention efforts.
We have also been working to increase access to the
emergency opioid overdose reversal drug, naloxone, and to
promote Good Samaritan laws so that witnesses can take steps to
help save lives. Many police and fire departments have already
trained and equipped their personnel with this life-saving
drug, and loved ones of people with opioid drug use disorders
are equipping themselves as well.
And while law enforcement and other first responders have
an important role to play, the medical establishment also must
become more engaged to identify and treat heroin and
prescription opioid use disorders. Every day, these people
appear in our emergency departments and other medical settings,
and more models and interventions are needed to get these
individuals engaged in care.
We also need to expand availability of evidence-based
opioid use disorder treatments. Medication-assisted treatment,
which uses FDA-approved medications, combined with behavioral
and other recovery supports, has been shown to be the most
effective treatment for opioid use disorders. Decisions about
the most appropriate treatment options and their duration need
to be agreed upon by both the patient and the treatment
provider.
We must also provide community supports, such as access to
housing, employment, and education, to give patients the
functional tools they need to lead healthier lives and fully
integrate into the community as part of their recovery process.
While we support multiple pathways to recovery, the
literature shows that short-term treatment, such as
detoxification alone, is not effective and carries risk of
relapse and overdose death. Because of the lack of availability
of evidence-based maintenance treatments and the strong
connection between injection of opioid drugs and infectious
disease transmission, we also promote the use of public health
strategies that will help prevent the further spread of
infectious disease. The HIV and hepatitis C outbreak in Scott
County, Indiana, is a stark reminder of how opioid use can
spread other diseases, how comprehensive public health
strategies, such as syringe exchange programs, need to be part
of the response to the opioid use epidemic, and how rural
communities that have limited treatment capacity may experience
additional public health crises.
Finally, we are continuing our efforts to address neonatal
abstinence syndrome. Research published just yesterday shows
that the incidence of NAS has grown nearly fivefold between
2000 and 2012 and that 81 percent of the 2012 hospital charges
for NAS were attributed to Medicaid. We must consider that the
best interest of babies with NAS is often served by best
addressing the interests of the mother. Therefore, we need to
provide safe harbor for pregnant and parenting women seeking
prenatal care and treatment.
In conclusion, we look forward to working with Congress and
our Federal partners on the next stage of action to address
this epidemic. Thank you.
[The prepared statement of Mr. Botticelli follows:]
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Mr. Murphy. Thank you.
Dr. Frank, we're going to try and get your testimony and
then we're going to run off and vote, and we'll be back. Go
ahead.
STATEMENT OF RICHARD G. FRANK
Dr. Frank. OK. Chairman Murphy, Ranking Member DeGette, and
members of the subcommittee, thank you for the opportunity to
discuss how the Department of Health and Human Services is
addressing the opioid abuse epidemic.
Containing the abuse and misuse of prescription opioids and
heroin is a high priority for the HHS leadership team, and
we're pleased to be here with you today. I would like to use my
time today to give you an overview of how we view the challenge
and describe how we are working to develop a multifaceted
solution to this problem. It's going to take a lot of
collaboration, and we are pleased to work with you and other
stakeholders on this issue.
Addiction to and abuse of opioids, including both
prescription painkillers and heroin and the terrible outcomes
associated with them, are growing at an alarming pace. Just
over a third of drug overdose deaths in 2012 and 2013 were from
prescription opioids, while heroin-related deaths have spiked
dramatically, almost tripling since 2010.
The sharp increase in the misuse and abuse of opioids
places a great burden on the health system. There were 259
million prescriptions filled for opioids in the U.S. in 2012, a
large increase over just a few years prior. The Medicare
program under part D spent $2.7 billion on opioids overall in
2011, 1.9 billion of that total, or 69 percent was accounted
for by the top 5 percent of opioid users. Those spending
patterns on these drugs reflect some of our concerns.
The cost of abuse and misuse of opioids shows up in
preventable use of very expensive health care. Heroin presents
an equally troubling, but different abuse and overdose pattern.
We saw increases between 2002 and 2009 in a number of people
using heroin, but that number has held fairly steady since
2009.
The striking new trend is that there's an increasing share
of the users that are dying from heroin overdoses. So what I'm
telling you is that we have a opioid prescribing problem,
sitting alongside a drug abuse and misuse problem.
Secretary Burwell is committed to aggressively addressing
the epidemic. She's driving us towards two main goals: One,
reducing opioid overdoses and overdose-related mortality; and
two, decreasing the prevalence of opioid use disorder. She
directed us to use the best science and to focus on the most
promising levers that can make a difference for the people who
struggle with opioid addiction and their families.
HHS agencies have been collaborating on this problem for
some time, and we hope you will agree after today that the
whole is greater than the sum of the parts.
Our actions informed by the evidence and discussions with
States and other stakeholders fall into three general
categories: One, addressing opioid prescribing practices; two,
expending the use of naloxone; and three, promoting medication-
assisted treatment.
Let me outline the plan in a bit more detail. First, PDMPs.
We're increasing investments in prescription drug monitoring
programs, which are among the most promising clinical tools to
curb prescription opioid abuse. We're investing it through
State grants and technical assistance and supporting best
practices to maximize the impacts of PDMPs.
Second, naloxone, which is the life-saving drug that can
reverse overdose from both prescription opioids and heroin.
We're supporting the development of user-friendly formulations
and delivery mechanisms and are working with State and local
governments to support training and other measures that get
naloxone into the hands of those that are in a position to
reverse overdoses.
Finally, we have plans to support the appropriate use of
medication-assisted treatment, or MAT. The enactment of the
Mental Health Parity and Addiction Act opens up new
opportunities to expand access to these evidence-based
treatments.
We are also working on identifying best practices in
primary care settings, increasing access to MAT through SAMHSA
grant support and potentially increasing the supply of MAT
providers by reviewing the policy and regulations that limit
the types of individuals certified to prescribe. Our commitment
to halting this complex public health epidemic is set out in
the President's 2016 budget that includes a $99 million
increase for parts of our initiative.
Finally, evaluation will help us identify the most
effective activities, allow us to continuously learn, and
inform future policy making in order to address this public
health concern.
So, in closing, this is critical for HHS and for the
Nation, and we can't do it alone. We need help. Thank you for
encouraging an open discussion of this today, and we are
committed to turning the tide on this scourge that has become
the opioid epidemic.
[The prepared statement of Mr. Frank follows:]
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Mr. Murphy. Thank you, Doctor.
Now, for the members--so votes are in progress. And even
though time is running out, just to let you know, I think only
about 20 people voted so far. So, apparently, this is throwing
everybody off in their schedules.
I apologize. This is what happens on Capitol Hill. But
we're committed to hear from you. We know how important this is
and we value your testimony. So we're probably going to be back
in a little under an hour. So we look forward to hearing from
you then and getting the rest of this testimony. Thank you.
[Recess.]
Mr. Murphy. All right. Thank you for being patient.
All right. Dr. Volkow, you're recognized for 5 minutes.
STATEMENT OF NORA D. VOLKOW
Dr. Volkow. Good morning, Chairman Murphy, Ranking Member
DeGette, and other members of the subcommittee. I want to thank
you for organizing and inviting me to participate in this
important hearing.
The nonmedical use of prescription pain relievers is a
particular public health challenge, for it demands solutions,
on the one hand, to prevent their diversion and misuse, while
at the same time, it demands so many solutions that will not
jeopardize access to these medications for those that need
them.
Opiate medications are probably among the most effective
painkillers that we have for the management of acute severe
pain, and the proper use can actually save lives. They act by
activating opioid receptors that are located in the areas of
the brain that perceive pain, but there are very high
concentration of opioid receptors in brain reward regions, and
hence, the problem. Activation of these receptors is what is
associated with their addiction potential.
There are also high levels of receptors in areas of the
brain that regulate breathing, which is why their use is
associated also with a high risk of death from overdose.
We have heard the devastating consequences from the
escalation of the abuse of prescription medications in our
country, the overdose deaths and transition to injection of
heroin and associated infections with HIV and hepatitis C, and
increasing numbers that we are seeing for the neonatal
abstinence syndrome.
NIDA's role in helping solve this epidemic is to support
the research that will help develop solutions to prevent and
treat abuse of prescription medications that could be
implemented now, while, at the same time, funding research that
in the future will provide transformative solutions.
There are already evidence-based practices that have been
shown to be effective in the prevention of overdose death that
include the use of medications for opioid addiction and the use
of naloxone to reverse opioid overdoses.
There are three medications currently available to treat
opioid addiction: methadone, buprenorphine, and naltrexone,
which, when used as part of a comprehensive addiction treatment
plan, have been shown to facilitate abstinence and reduce
overdoses and HIV infections. Also, when coupled to prenatal
care in pregnant women addicted to opioids, these medications
reduce the risk of obstetrical fetal and neonatal
complications. Yet, despite the strong evidence, less than 40
percent of those receiving treatment for opioid addiction get
treated with these medications. Toward this end, NIDA is
funding research on implementation strategies that facilitate
the use of medications for opioid addiction in the healthcare
system.
Another key component to decrease the overdose deaths is to
expand the use of naloxone, so NIDA has partnered with
pharmaceutical companies to develop user-friendly, effective
delivery systems for naloxone that will facilitate their use by
those that have absolutely no medical training.
In addition, NIDA supports research on the treatment of
pain and on the treatment of opioid addiction that will offer
new solutions for the treatment of these two disorders.
Examples for the management of pain include the development of
drug combinations or new formulations with less addiction
potential, the development of analgesics that do not rely on
the opioid system, and the development of nonmedication
interventions, such as the use of transcranial magnetic or
electrical brain stimulation for pain management.
Examples of research on the treatment of opioid addiction
include the development of slow-release formulations that need
only once-a-month or once-every-6-months dosing--which will
facilitate compliance and use--and the development of vaccines
against heroin, which will prevent the delivery of the drug
into the brain, hence, interfering with its rewarding effects
and adverse consequences.
Because the epidemic of prescription drug abuse resulted
from a lack of knowledge by healthcare providers, the
importance of developing curriculum to train both in pain and
in substance abuse disorders is another priority which NIDA has
developed in partnership with the other institutes and NIH
Centers of Excellence.
There were over 24,000 deaths from opioid overdoses in
2013. Twenty-four thousand. This highlights the urgency to
address this epidemic. Solutions are already available. The
challenge is the implementation. This requires strong
integration of efforts, and NIDA will continue to work closely
with other Federal agencies, community organizations, and
private industries to address this complex challenge.
[The prepared statement of Dr. Volkow follows:]
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Mr. Murphy. Thank you.
Dr. Throckmorton, 5 minutes.
STATEMENT OF DOUGLAS C. THROCKMORTON
Dr. Throckmorton. Mr. Chairman, Ranking Member DeGette,
and members of the subcommittee, I am Dr. Douglas Throckmorton,
Deputy Director for Regulatory Programs within FDA's Center for
Drug Evaluation and Research. Thank you for the opportunity to
be here today to discuss FDA's role in combating opioid abuse
and encouraging the safe use of these important drugs.
Our goal is to find the balance between needing to treat
patients with pain, including the use of opioids where
appropriate, and needing to reduce opioid drug abuse. This work
is being done together with other parts of the Federal
Government, and we know that a successful and sustainable
response must include Federal and State Government, public
health officials, opioid prescribers, addiction experts,
researchers, manufacturers, and patient organizations.
For our part, FDA plays a central role in the regulation
and use of drugs from their discovery and throughout their
marketing. For example, when FDA reviews a drug for possible
marketing, we also approve drug labeling, which includes
information about approved uses about the medicine, as well as
information about potential safety risks. FDA also carefully
follows drugs after they are marketed, including opioid drugs.
Where necessary, this enables us to take a variety of actions
to improve their safe use, such as changes to approved
labeling.
The first area of FDA activity I'd like to highlight is our
work to support the development of abuse-deterrent formulations
that make opioids harder or less rewarding to abuse. While this
is not a silver bullet that will prevent all abuse, FDA
believes abuse-deterrent opioids can help reduce opioid abuse.
To incentivize their development, FDA recently issued final
guidance on abuse-deterrent formulations, guidance we are using
now to meet with sponsors interested in developing them.
To date, FDA has received some 30 investigational new drug
applications from manufacturers. In addition, we have approved
four opioid drugs with abuse-deterrent claims in their
labeling.
Overall, then, while we are in the early stages of
development, I am encouraged by this level of work. FDA
envisions a day not far in the future when the majority of
opioids in the marketplace are in effective, abuse-deterrent
forms.
Next, with regards to prescribing opioids, we know that
they are powerful medicines, and FDA believes that it is
critically important to ensure that prescribers have high
quality education about how to use them in pain management.
Over the past several years, FDA has done several things to
improve educational materials on opioids. For example, we
recently finalized required changes to the approved labels of
extended-release, long-acting opioids, changing their
indication to inform prescribers that these drugs should only
be used for pain severe enough to require daily around-the-
clock treatment when alternative treatments would not work.
At the same time, FDA strengthened significantly the safety
warnings on these opioids. We want prescribers to use them with
care, and today, the labels for extended-release, long-acting
opioids are among the most restrictive of any drugs that we
have in the center, and have clear language that calls
attention to their potentially life-threatening risks.
FDA's also working to improve the information available for
prescribers in other ways. Under certain circumstances, FDA can
require manufacturers, as a part of a risk evaluation and
mitigation strategy, to address safety concerns such as opioid
abuse. In 2012, FDA required manufacturers to fund the
development of unbiased continuing education programs on opioid
prescribing practices for prescribers. In the first year since
that program has been in place, approximately 6 percent of the
320,000 prescribers, around 20,000 prescribers of extended-
release and long-acting opioids, have completed one of those
courses. We believe this training for prescribers is important.
We also support mandatory education for prescribers of opioids,
as called for by the administration in the 2011 Prescription
Drug Abuse Prevention Plan, and reemphasized in the 2014
National Drug Control Strategy.
Finally, FDA has been working with many other stakeholders,
including the agencies here today, to explore the best ways to
prevent overdose deaths by the expanded use of naloxone. As
others have said, it can and does save lives. FDA is working to
facilitate the development of naloxone formulations that could
be easier to use by anyone responding to an overdose. First,
FDA meets with manufacturers whenever needed and is using
whatever tools we can to expedite product development. We
recently approved the first auto-injector formulation of
naloxone, which is intended to be administered by people
witnessing an overdose, such as family members and caregivers.
We completed that review and approved this product in 15 weeks.
Going forward, we continue to work on how best to use
naloxone. As a part of this work, FDA, and many of the others
agencies at this table, are planning a public meeting in July
to bring together key stakeholders to deal with questions of
access, coprescribing of naloxone, and State and local best
practices.
In conclusion, as a society, we face an ongoing challenge
and a dual responsibility. We must balance efforts to address
opioid drug misuse, abuse, and addiction against the need for
access to appropriate pain management. These are not simple
issues and there are no easy answers. FDA is taking important
actions we hope will achieve this balance. We welcome the
opportunity to work with Congress, our Federal partners, the
medical community, advocacy organizations, and the multitude of
interested communities and families to turn the tide on this
devastating epidemic.
Thank you for this opportunity to testify. I look forward
to answering any questions that I can.
[The prepared statement of Dr. Throckmorton follows:]
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Mr. Murphy. Thank you, Doctor.
Dr. Houry.
STATEMENT OF DEBRA HOURY
Dr. Houry. Chairman Murphy, Ranking Member DeGette, I would
like to thank you for inviting me here today to discuss this
very important issue. I would also like to thank the committee
for your continued interest in prescription opioid abuse and
overdose. My name is Dr. Debra Houry, and I am the director of
the National Center for Injury Prevention and Control at the
CDC.
As a trained emergency room physician, I have seen
firsthand the devastating impact of opioid addiction on
individuals and their families, as well as the importance of
prevention. Together, we have witnessed a deadly epidemic
unfolding in States and communities across the country. The
overdose epidemic is driven, in large part, by fundamental
changes in the way healthcare providers prescribe opioid pain
relievers. Enough prescriptions were filled in 2012 for every
American adult to have their own bottle of pills. As the amount
of opioids prescribed increased, so has the number of deaths.
In alignment with the Department's initiative, I want to
highlight CDC's work in developing evidence-informed opioid
prescribing guidelines for chronic pain and providing direct
support to States to implement multi-sector prevention
programs.
CDC is currently developing guidelines for the prescribing
of opioids for chronic noncancer pain. This undertaking is
responsive to a critical need in the field. These new
guidelines will redefine best practices around opioid
prescribing for chronic pain and make important advances in
protecting patients. The audience for these guidelines are
primary care practitioners, who account for the greatest number
of prescriptions for opioids compared to other specialties. The
guidelines process is underway, and our goal is to share a
draft for public comment by the end of this year. We have plans
in place to encourage uptake and usage of the guidelines among
providers, which is key for improving prescribing practices.
The second activity I would like to highlight is our major
investment in State-level prevention. States are at the front
lines of this public health issue, and CDC is committed to
equipping them with the expertise they need to reverse the
epidemic and protect their communities. Utilizing the newly
appropriated $20 million, we recently published a new funding
opportunity called Prescription Drug Overdose: Prevention for
States. It builds upon existing CDC-funded State programs and
targets States that have a high drug overdose burden and those
that demonstrate readiness needed to combat the epidemic. It
requires collaboration across sectors for a truly comprehensive
response.
The goals for this program are to make prescription drug
monitoring programs more timely, easier to use, and able to
communicate with other State PDMPs, to implement Medicaid or
Workers' Compensation interventions to protect patients at
risk, and to bring data-driven prevention to the communities
struggling with the highest rates of drug abuse and overdose.
States also will be given the flexibility to use the program to
respond to emerging crises and develop innovative interventions
so they know what works to reduce overdose and save lives in
their community.
The development of opioid prescribing guidelines and our
State prevention program are two key ways that CDC's broad work
on the epidemic contributes to the Department's initiative.
We are also examining the increase in heroin use and
overdose. Heroin overdose deaths have more than doubled since
2010, and prescription opioid abuse, a key risk factor for
heroin use, has contributed significantly to this rise in
heroin use and overdose. We will leverage our scientific
expertise to improve public health surveillance of heroin and
evaluate effective strategies to prevent future heroin
overdoses.
Addressing this complex problem requires a multifaceted
approach and collaboration among a variety of stakeholders, but
it can be accomplished, particularly with the ongoing efforts
of all of the organizations represented here on this panel.
CDC is committed to tracking and understanding the
epidemic, supporting States working on the front lines of this
crisis, and providing healthcare providers with the data,
tools, and guidance they need to ensure safe patient care.
Thank you again for the opportunity to be here with you
today and for your continued work and support of us protecting
the public's health. I look forward to your questions.
[The prepared statement of Dr. Houry follows:]
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Mr. Murphy. Thank you, Doctor.
Pamela Hyde, welcome back.
STATEMENT OF PAMELA S. HYDE
Ms. Hyde. Good morning, Chairman Murphy, Ranking Member
DeGette, and members of the subcommittee. Thank you for
inviting SAMHSA to be part of this hearing, and thank you for
your interest in this important public health issue.
According to SAMHSA's National Survey on Drug Use and
Health, the prevalence rate of nonmedical use of prescription
opioids is high, approximately 4.5 million individuals in 2013.
Heroin use is much lower, About 289,000 individuals reporting
past month use, but that's doubled in 5 years.
Fortunately, the nonmedical use of pain relievers has
actually decreased some from 2009 to 2013, especially among
young people 12 to 17. However, as you know, overdoses and
overdose-related deaths from both prescription drugs and heroin
have risen dramatically among all ages. And as you've heard,
few who need treatment are receiving the comprehensive
community-based services they need to live lives in recovery,
free of addiction.
SAMHSA believes prevention is the priority and recovery is
the goal. SAMHSA's programs, data, practice improvement, public
education, and regulatory efforts are all designed to prevent
addiction and overdoses, help provide the treatment and
services needed for people with substance abuse disorders to
achieve recovery, support their families, and foster supportive
communities.
SAMHSA funds the American Academy of Addiction Psychiatry,
together with six other medical societies, to train prescribers
in the best approaches to pain management. SAMHSA also educates
physicians on medication-assisted treatment for opioid
addiction. SAMHSA's Addiction Technology Transfer Centers
provide training and materials on opioid use disorders, and are
cofunded with NIDA to distribute research-based best practices
to the field of addiction treatment.
To help prevent opioid-overdose-related deaths, SAMHSA
alerted States last year that substance abuse treatment block
grant funds may be used to purchase and distribute naloxone and
increase education and training on its use. Also in 2014,
SAMHSA updated its opioid overdose prevention toolkit to
educate individuals, families, first responders, and others
about steps to prevent and reverse the effects of opioid
overdoses, including the use of naloxone. This toolkit's one of
the most downloaded resources on SAMHSA's Web site.
The President's 2016 budget includes $12 million in
discretionary grants for States to purchase and distribute
naloxone, equip first responders in high risk communities, and
support education on the use of naloxone and other overdose
prevention strategies.
SAMHSA also supports medication-assisted treatment as part
of a recovery-oriented, person-centered care model. Medication-
assisted treatment is not meant as a standalone approach, but
rather is designed to include medication, counseling,
behavioral therapies, and recovery supports.
In March 2015, SAMHSA issued revised Federal guidelines for
opioid treatment programs which highlight this recovery-
oriented care model, and encouraged the use of any of the three
FDA-approved medications for the treatment of opioid use
disorder based on an assessment of each individual's unique
needs.
SAMHSA's also taking an integrated clinical care approach
as part of a new 2015 grant program to expand and enhance the
availability of medication-assisted treatment and other
clinically appropriate services in States with the highest
rates of opioid admissions. The President's 2016 budget
proposes to double this program.
In collaboration with DOJ and ONDCP, SAMHSA added language
to its 2015 treatment drug court grant requirements to ensure
that drug court clients will not be compelled to stop or be
prevented from using medication if it is prescribed or
dispensed consistent with a licensed prescriber's
recommendation, a valid prescription, or as part of a regulated
opioid treatment program.
SAMHSA regulates opioid treatment programs, which are
expected to provide a full range of services for their
patients. In collaboration with the Drug Enforcement
Administration, SAMHSA provides waivers to physicians wishing
to treat opioid use disorders with buprenorphine in a practice
setting other than an opioid treatment program.
SAMHSA also funds efforts to help prevent prescription
opioid misuse and heroin use. For example, in 2014, SAMHSA's
Strategic Prevention Framework--Partnerships for Success
program, made preventing and reducing heroin use one of its
focus areas, along with prescription drug misuse and abuse, and
underage drinking. For 2016, the President has proposed $10
million for the Strategic Prevention Framework Rx, or SPF Rx,
to help States use data, including PDMP data, to identify and
assist communities at high risk for the nonmedical use of
prescription drugs.
We want to thank you, again, for taking on this issue and
for allowing SAMHSA an opportunity to share some of its efforts
with you. We look forward to answering your questions.
[The prepared statement of Ms. Hyde follows:]
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Mr. Murphy. Thank you, Ms. Hyde.
Dr. Conway, you're recognized for 5 minutes.
STATEMENT OF PATRICK CONWAY
Dr. Conway. Chairman Murphy, Ranking Member DeGette, and
members of the subcommittee, thank you for inviting me to
discuss the CMS's work to ensure that all Medicare and Medicaid
beneficiaries are receiving the medicines they need, while also
reducing and preventing prescription drug abuse.
As we have heard from other witnesses, opioid analgesics
have increasingly been implicated in drug overdose deaths over
the last decade. As a practicing physician, I understand the
importance of this issue.
CMS recognizes our responsibility to protect the health of
Medicare and Medicaid beneficiaries by ensuring that
appropriate safeguards are in place to help prevent overuse and
abuse of opioids, while ensuring that beneficiaries can access
needed medications and appropriate treatments for substance
abuse disorder.
Since its inception in 2006, the Medicare part D
prescription drug benefit has made medicines more available and
affordable, leading to improvements in access to prescription
drugs and better health outcomes.
Despite these successes, part D is not immune from the
nationwide epidemic of opioid abuse. CMS has broadened its
initial focus of strengthening beneficiary access to prescribed
drugs to also address potential fraud and drug abuse by making
sure part D sponsors implement effective safeguards and provide
coverage for drug therapies that meet safety and efficacy
standards.
We believe that broader reforms that result in better
coordinated care will help protect beneficiaries from the
damaging effects associated with prescription drug abuse and to
prevent and detect overutilization related to prescription
drugs.
A centerpiece of our strategy is to strengthen CMS's
monitoring of part D plan sponsors' drug utilization management
programs, to prevent overutilization of these medications. To
accomplish this goal, the Medicare part D overutilization
monitoring system, or OMS, was implemented in 2013. Through
this system, CMS provides reports to sponsors on beneficiaries
with potential opioid overutilization identified through
analysis of prescription drug event data and through
beneficiaries referred by the CMS Center for Program Integrity.
Sponsors are expected to utilize various drug utilization
monitoring tools to prevent continued overutilization of
opioids. Recent data has shown that from 2011 to 2014, the OMS
has reduced the number of potential opioid over-utilizers by
appropriately 26 percent.
CMS also utilizes the Drug Integrity Contract, or MEDIC,
which is charged with identifying and investigating potential
fraud and abuse, and developing cases for referral to law
enforcement agencies. In 2013, CMS directed the MEDIC to
increase its focus on proactive data analysis in part D. CMS
has also used our rule-making authority to create new tools to
take action against problematic prescribers and pharmacies. We
recently finalized a provision that requires prescribers of
part D drugs to enroll or have a valid opt-out affidavit on
file, and establishes a new revocation authority for abusing
prescribing patterns.
State Medicaid agencies have also taken action to tackle
the opioid abuse epidemic. Efforts include expanding the
Medicaid benefit to include behavioral health services for
those with addiction to prescription drugs and pharmacy
management review programs. Although CMS does not determine
what services are provided in each Medicaid program to prevent
and treat opioid abuse, we are encouraged by the increasing
efforts by States to develop effective strategies for designing
benefits for this population.
We recently launched the Medicaid Innovation Accelerator
Program, or IAP, to provide States with technical assistance
and other types of support to address this important issue.
CMS, in coordination with CDC, SAMHSA, and NIH, issued an
informational bulletin on medication-assisted treatment for
Substance Abuse Disorder in the Medicaid program. This guidance
outlines that a combination of medication and behavioral
therapies is the most effective combination of treatment. We
issued a similar bulletin focused on these services in the
pediatric and youth population.
CMS is dedicated to providing the best possible care to
beneficiaries with opioid addiction, and is working with part D
sponsors and State Medicaid programs to implement effective
safeguards to prevent opioid abuse and treat patients
effectively with substance abuse disorders.
CMS has made progress, but there is more work to be done.
CMS is undertaking multiple policy initiatives and
interventions to reduce the rate of opioid addiction and
overdoses in both Medicare and Medicaid.
In previous testimonies, I've never had family here or the
time to thank them, so I do want to thank my mother, Diane
Conway, is here and my son, Jack, who's out of school, as well
as my wonderful wife, Heather, and daughters Alexa and
Savannah. And without their love and support, I would not be
able to work on issues like this that are critically important
to our Nation. So thank you.
[The prepared statement of Dr. Conway follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Doctor. And thank you for
recognizing Take Your Family to Testifying Day. Apparently
everybody else did not get the memo.
I just want to start out by saying if talent and dedication
alone could solve this crisis, we'd be there with the testimony
of today and other days, but obviously, we still have problems.
So let me start off with asking a few questions.
First, for Director Botticelli, for the Office of National
Drug Control Policy, or ONDCP, uses the term ``recovery,'' does
it mean to include patients with opioid addiction in a
buprenorphine or methadone treatment program and still using
heroin or other illicit drugs, or would you say that's not
recovery?
Mr. Botticelli. So I think, you know, from our perspective,
and also as a person in recovery, clearly we want to make sure
that people are continuing to progress in their recovery, and
that kind of freedom from substances is the ultimate goal of
recovery programs, and I think everyone would agree on that,
but we also know that substance use, and particularly opioid
use disorders, are a significant chronic disorder, and that
oftentimes, and even my own experience show me, that people
often will experience relapse and will often, I think, need
multiple attempts at treatment to get to that final goal of
long-term recovery and long-term abstinence.
And so we really want to make sure that we're continuing to
engage with patients, that we're moving them toward better
health, better recovery, and being free from substance abuse as
part of long-term recovery.
Mr. Murphy. Well, let me ask in context of this, because we
also heard from testifiers last week they felt there was not a
uniform definition of recovery, but, I mean, this is the talent
pool here, you're the ones that do these. Do you all meet on a
regular basis to talk about these issues? And when was the last
time you all got together to talk about policy issues? Was it
within the last--can someone answer that? Pam? Pam Hyde?
Mr. Botticelli. So let me start.
Mr. Murphy. Oh, you will start? OK.
Mr. Botticelli. Let me start with that, because it's
actually part of our statutory authority----
Mr. Murphy. OK.
Mr. Botticelli (continuing). That we set in conjunction
with, not just our HHS partners, but with all of the Federal
agencies that have a role in substance use, and particularly in
opioid use disorders. We have been engaged with the DOD and the
VA and the Bureau of Prisons.
Mr. Murphy. So you all meet regularly?
Mr. Botticelli. We actually do meet regularly. So we have
quarterly meetings to focus on where we are.
Mr. Murphy. Well, let me move on that too, because that's
going to be important.
Ms. Hyde, let me ask you a question here in your response
to our bipartisan letter of March 18 concerning the National
Registry of Evidence-Based programs, you noted that, quote,
``new submission and review procedures will improve the rigor
of the registry and bring NREPP into closer alignment with
other registries of evidence-based programs in the Federal
Government.''
Now, prior to entering into this July 2014 contract, did
SAMHSA feel that the scientific basis of the rigor of NREPP
needed to strengthened, yes or no? I mean, do you feel it
needed to be strengthened?
Ms. Hyde. Thank you for the question. We thought the
process that we used for determining what practices were
reviewed needed to be strengthened, and in the process, we have
also increased the rigor with which we look at them.
Mr. Murphy. Can you get us a list, not today, but can you
get us a list of what you consider to be some of the models
within the Federal registry that we can review as part of that,
as evidence-based programs?
Ms. Hyde. Certainly.
Mr. Murphy. OK. Thank you.
Your response also indicates an outside contractor will
assume the role of gatekeeper for NREPP, determining which
studies and outcomes are reviewed in the screening and review
of an intervention, with the aim of preventing bias in favor of
the intervention developers.
Was SAMHSA's prior system for vetting and selecting
interventions to be included in the NREPP prone to any kind
developer bias or conflict of interest? Was that a concern?
Ms. Hyde. Yes, Mr. Murphy, it was a concern. It was pretty
much developer driven. So a developer had to want their
practice to be reviewed, and then they had some control over
what research we looked at. We have changed that with the new
contract, which began last year, and we will help decide
priorities together with the public input, but the contractor
will help us look more objectively at evidence.
Mr. Murphy. Thank you. I just pulled up here--I just got a
note, actually an article that, was this one of your
constituents, Dr. Frank, from eastern Colorado? I don't want to
take all your Colorado thunder, but it was fascinating article,
because it made reference to the increased use of emergency
departments associated with opiates. And it's interesting, they
said that the reasons for this is--first of all, they said
there's 10-1/2 million estimated people with this, it's
probably an underestimate, that people go to the emergency
rooms for treatment for withdrawal, but also many trying to get
more opiates; and that when you have users with opiate
prescriptions from more than one physician, they're more likely
to be involved in riskier practices.
I wonder if any of you could comment on if that's an area
that we're trying to address. I think, Dr. Volkow, you were
also talking about issues with regard to prescribing practices,
and Dr. Frank. Can some of you comment on those issues?
Dr. Volkow. Yes. And I think that that article, I think,
that you're referring to the New England Journal of Medicine
article that shows that there's been a very significant,
quadruple number of cases of neonatal abstinence syndrome in
the intensive care units, and this does reflect the fact that
many women are actually being prescribed opioid medications
during the pregnancy itself. And, actually, based on another
study, it was estimated that 21 percent of women that are
pregnant are going to receive an opioid medication, which,
again, highlights the need to enforce better that the
guidelines on the management of pain need to be enforced in
better ways. And this is also recognized by studies that have
actually evaluated the extent to which physicians are following
guidelines by the main medical organizations as it relates to
the management of pain. So that is an area where there needs to
be an aggressive increase in the education and enforcement of
guidelines.
Mr. Murphy. Thank you. I'm out of time. I'd just ask
unanimous consent that I can submit this research article for
the record.
[The information appears at the conclusion of the hearing.]
Mr. Murphy. Ms. DeGette, you're recognized for 5 minutes.
Ms. DeGette. Thank you, Mr. Chairman.
Dr. Volkow, as I mentioned in my opening statement, you're
one of the world's top experts on the issue of treating
addiction. Briefly, what does the body of scientific evidence
show regarding the effectiveness of methadone and buprenorphine
in this treatment of opioid abuse disorders?
Dr. Volkow. What the research has shown--and it has shown
it not just for methadone and buprenorphine, but a more recent
medication, naltrexone--is that these medications when used as
part of a comprehensive program for the treatment of opioid
addiction are quite effective, and they significantly improve
the outcomes of individuals being able to stay, on the one
hand, abstinent from the drug or to decrease the likelihood of
relapsing, but it also protects them against the adverse
outcomes, such as overdoses.
Ms. DeGette. So in light of those studies, you also said in
your testimony that existing evidence-based prevention and
treatment strategies are highly underutilized across the United
States. And last week we had an expert tell our panel that very
few patients with opioid addiction today receive treatments
that have been proven most effective. He was talking about this
rapid detox followed by abstinence-based treatment.
I'm wondering, Dr. Volkow, if you can help understand this.
Why do we have a situation where people are not getting
evidence-based treatment?
Dr. Volkow. Well, one of the problems has been--and it's a
complex problem and there are many reasons why they're not
getting the correct treatment, including the fact of adequate
education as it relates to the proper screening and management
of substance abuse disorder, including the healthcare system.
Then you have a whole infrastructure that has developed because
addiction is stigmatized, so, therefore, the likelihood of
people accessing that medical care is much lower. And then, of
course, there is a difference between States in the way that
they implement the treatment. So all of these factors account
for the current situation.
Ms. DeGette. Dr. Frank, do you have anything to add to
that?
Dr. Frank. Yes, I do. I think that one thing that's very
important to remember is that overall, we treat 10 percent of
the people with these disorders, so it's not surprising that
people aren't getting evidence-based treatment, because they're
not getting treatment, period.
Second part is why aren't they getting evidence-based
treatment among those who do? And I think that there are
insurance dynamics that hopefully we're fixing, there are, as
Dr. Volkow said, access to trained professionals who are
trained in the best things, and then there's, in a sense,
trying to kind of get the systems and the infrastructures
aligned so that they support the best practices.
Ms. DeGette. And, Dr. Houry, several of our witnesses,
including you, mentioned the role of the States in this. Can
you talk about that for a minute?
Dr. Houry. Absolutely. I think States have different
populations, different issues, different prescription drug
monitoring programs, and so tailoring these programs for States
so they can best identify, whether it's their State Medicaid
program, other high-risk programs or patients and how to best
target them, and that's why the program at the CDC is really
helpful, because we have the higher level view to work across
the States for this.
Ms. DeGette. And do you think the States have work to do in
terms of implementing these programs that are science-based and
that work?
Dr. Houry. You know, I think we're starting to do that.
Like, our program itself has only been in existence for 6
months, but we're seeing great progress. And if you look at
some of the policies that States are implementing, we're seeing
reductions in what we call doctor shopping and patients going
to different doctors, because of utilizing prescription drug
monitoring programs. So although it's early in the stage, I'm
very optimistic that we are making progress in the States.
Ms. DeGette. OK. Dr. Volkow, I want to come back to you.
One of our other experts last week said patients and their
families need to know that detoxification treatment and drug-
free counseling are associated with a very high risk of
relapse.
I'm wondering if you can tell us what the science shows. Is
this type of treatment generally effective or less effective?
What does the research show?
Dr. Volkow. The research has shown that in general, fast
detoxification of patients is associated with increased
mortality, like what you just mentioned. And this reflects the
fact that addiction is a chronic disease and the changes that
occur in the brain persist months, years after you've stopped
taking the drug.
So what they do in this fast detoxification is just remove
the physical dependence and assume that the addiction is cured,
and these are two independent processes, and as a result of
that, the patient feels that they are safe and then they
relapse because they are still addicted----
Ms. DeGette. Thank you.
Dr. Volkow (continuing). And many times they overdose.
Ms. DeGette. Thank you.
Thank you very much, Mr. Chairman.
Mr. Murphy. I now recognize Mr. Collins for 5 minutes.
Mr. Collins. Thank you, Mr. Chairman. This is truly a
fascinating topic we're discussing, and it's obvious there's no
very easy solution. I mean, we've heard it's a chronic disease,
10 percent are seeking treatment. I guess my question maybe for
Ms. Hyde at SAMHSA is, you know, certainly with pregnant women
that may have young kids at home, and inpatient treatment might
be the preferred, and we just can't let perfect be the enemy of
good, what other options are you looking at for people who
can't get in, I mean, they're just not going to enter
inpatient, so they may be part of the 90 percent not getting
treatment at all? Some treatment better than no treatment, as
frustrating as that might be? What are your comments to the
young mother that's got kids at home and she's pregnant and
she's dependent and she just can't go into an inpatient center?
What do we do for that patient?
Ms. Hyde. Thank you for the question. The issue of pregnant
and parenting women is a big one in our field. We do have a
small program to address that issue, but you're right, it's a
residentiallybased program.
We have increasingly been looking at ways to take what we
learn in that program about the best ways to treat pregnant and
parenting women and take it into other settings, so whether
it's our opioid treatment programs or the training that we do
for physicians who are using medication-assisted treatment to
deal with pregnant and parenting women. So we're trying in
every way that we can to make those services available to those
women.
Mr. Collins. So, again, with pregnant women, and we're
looking at other treatments, I guess, whether that's
buprenorphine or methadone, are there studies that show whether
that has an impact on the fetus and the baby?
Ms. Hyde. You're right to be concerned about the child.
What we see is that this prevents death, it prevents addiction
of the baby, it prevents a lot of other issues that may come
with allowing the young woman to continue with the illicit drug
use or the prescription opioid misuse. So definitely providing
treatment helps both the woman and the child.
Mr. Collins. Now, as you've counseled these women, what
kind of reaction are you getting? Are they recognizing--and you
would think the genuine concern they have for the baby. I mean,
there's very much a complicated balancing act going on here.
What kind of reactions are you getting from the women
acknowledging the problem and wanting to treat it?
Ms. Hyde. You know, most pregnant and parenting women
really want to do the best thing for their babies, and they
want to do the best thing for themselves, but as you've heard,
addiction is a chronic disease and it's very difficult; changes
the brain, changes the ability to make decisions.
The women who are in the programs that we provide support
for find it a very helpful program with the kind of supports,
because we provide a range of programs, and we've recently
introduced medication-assisted treatment into those programs as
well.
Mr. Collins. So are these women finding you on their own,
or are their physicians guiding them to you?
Ms. Hyde. The women who come to our programs come from a
variety of places; some from the correctional system, some from
physicians, some from family, some from self-referral. So they
come from a number of places, and we don't make a distinction
between where they come from in terms of providing the care.
Mr. Collins. Well, it's something this committee's very
concerned with. And, again, Mr. Chairman, thank you for holding
this hearing and for all of your testimony. I wish there was an
easy solution. There just doesn't appear to be one. So this is
going to have to be addressed on a lot of fronts. And with
that, I yield back.
Mr. Murphy. Mr. Tonko, you're recognized for 5 minutes.
Mr. Tonko. Thank you, Mr. Chairman. And let me join in
welcoming the Conway family to the hearing, and let me
compliment the Honorable Michael Botticelli for having the
roots, origins in the 20th Congressional District of New York.
So welcome all.
One of the biggest concerns I hear from individuals and
families struggling with addiction is the difficulty they have
accessing treatment. As you know, with the Mental Health Parity
and Addiction Equity Act, as well as with our Affordable Care
Act, millions more people have gained access to mental health
and substance use services. However, recent reports have laid
bare the fact that these new treatments as options sometimes
exist on paper only.
So my question first to Assistant Secretary Frank, Dr.
Frank, what is HHS planning to do to increase the public
disclosure of the Medicaid management practices insurers use
both on the commercial side and on Medicaid and CHIP so that
consumers can truly evaluate their health plans to make sure
they are in compliance with parity?
Dr. Frank. Thank you for the question. We, too, view the
Mental Health Parity Act as an incredibly important opportunity
to increase the use of evidence-based practice and access to
treatment.
We are doing a number of things. We work with both the
Department of Labor on the ERISA side of the commercial health
insurance side. We've trained the ERISA investigators in how to
detect deviations from parity arrangements within insurance,
and so they are out there fully trained now working on these
issues. We have a group within HHS who regularly provides
technical assistance to State insurance commissioners and works
with them to resolve complaints as they arise. And we've
continued a series of forums and technical assistance around
the country. And we're working with stakeholders, some of whom
are in this room today, to improve our ability to ask for
disclosure and to offer up consumers the opportunity to really
make that evaluation that you referred to.
Mr. Tonko. Thank you, Assistant Secretary.
And Director Botticelli, I would like to talk about another
barrier to treatment for some patients. And press accounts have
suggested that some States are denying patients access to drug
courts if they are receiving medication-assisted treatments, or
MATs. I understand this has been a problem in Kentucky, at
least according to some press accounts. So, Director, can you
explain what is going on here? Given the importance of MATs,
why are some judges attempting to cut patients off of medicines
that can actually help them recover?
Mr. Botticelli. Thank you, Congressman. And as many of my
colleagues have talked about today, increasing access to
medication-assisted treatment along with other behavioral
therapies is the best course of treatment for people with an
opiate use disorder. Unfortunately, one of the access issues
that we find in addition to issues around payment has been
particularly lack of access within the criminal justice system,
and we know that many people with opioid use disorders are
ending up in our system.
Drug courts, some drug courts have not adapted policies
that the National Association of Drug Court Professionals
endorse in terms of ensuring that people who do have an opioid
use disorder get access to those medications, as well as not
predicating their participation that they get off these
medications.
Part of what we've been doing on the Federal level is using
our Federal contracting standards to ensure that people with
opioid use disorders, whether it's in a drug court or a
treatment program or in other venues, are offered access to
medication-assisted treatment and are not denied participation
based on the fact that they are on physician-prescribed
medication.
Mr. Tonko. Dr. Volkow, on that same issue, do you agree
with the assessment?
Dr. Volkow. Yes, I agree very much. And at the same time,
we are developing alternatives that may be more amenable for
the criminal justice system, like prison or jail, like the
naltrexone antagonist, so there is no reason why they should
not get access to medication.
Mr. Tonko. OK. And another barrier that patients face is
the lack of available treatment providers who can prescribe
MATs. Director Botticelli, can you comment on this dearth of
providers who can prescribe buprenophrine, for example, what
are some of the reasons for the shortage and what can we do to
address it?
Mr. Botticelli. One of the other opportunities that we have
is ensuring that all of our treatment programs either offer
medication-assisted treatment or to refer to programs that have
medication-assisted treatment. An analysis of our treatment
programs show that a very low percentage of them have
incorporated medication-assisted therapies into their programs.
Some of this, Congressman, quite honestly, has been by myth and
misunderstanding and this divide between abstinence-based care
and medication-assisted treatment, which I think is really
unfortunate that we have here, so we really want to make sure
that if a client is entering a treatment program that has
particularly Federal funding needs to offer, by way of its own
offering or through referral, medication-assisted treatment.
Mr. Tonko. All right. Thank you very much. And thank you to
the entire panel for guiding us in this crisis situation.
Mr. Murphy. I just want to ask as a clarification for the
question you were asking about the drug courts and the use of a
medication-assisted treatment. So you're recommending
medication-assisted treatment as part of an option package,
although you say obviously we want to get people free from
drugs all together, does it require a recommended practice from
your agencies to get drug courts to do that? Does it require
regulatory changes from one of your agencies to do that? Or
does it require a legislative solution from us to do that?
Mr. Botticelli. And other panelists could add--this is--
we've actually been doing that as a condition of their
Federal----
Mr. Murphy. OK.
Mr. Botticelli (continuing). Drug court language.
Mr. Murphy. OK.
Mr. Botticelli. You know, again, we want this to be decided
by an expert in addiction services in consultation with the----
Mr. Murphy. OK.
Mr. Botticelli (continuing). But we just didn't want to
have categorical denial.
Mr. Murphy. Ms. Hyde, are you adding to that question?
Ms. Hyde. I did mention in consultation with ONDCP and also
with the Department of Justice, we have changed the language in
our request for applications for drug courts so that they can't
require that someone either get off of or not be on medication-
assisted treatment if it is prescribed appropriately by a
physician or a certified program.
Ms. DeGette. So I just wanted to add, though, what you can
do, you can make the Federal funding contingent on full
programs, but we can't force the States or whatever regulatory
agency is setting up the drug courts to offer this. They just
can't get Federal money if they don't offer it.
Mr. Botticelli. And this is where I'm glad the committee is
actually going to be talking at State level, because as a
former State administrator, States do play a crucial role.
There are many, many programs out there that actually don't
receive Federal funding, or drug courts that don't receive
Federal founding. We hope that our policies and procedures are
adopted by those nonfederally funded programs, but States play
a key role in licensing treatment programs.
Mr. Murphy. Thank you.
Mr. Botticelli. And they, I think, can look at the
opportunities of increasing or ensuring that State licensing
treatment programs also the have same kind of language.
Mr. Murphy. Thank you. Speaking of States, go to the
gentleman from West Virginia, Mr. McKinley, for 5 minutes.
Mr. McKinley. Thank you very much, Mr. Chairman, and thank
you again for these hearings that we've been having on this
topic.
As an engineer, I need to see things in perspective, and so
I guess we've been following this over the last 4 years in
Congress, and especially on this committee, been trying to look
at this issue, and I think at one of the last meetings we just
had, I tried to put it in perspective by saying from--
Botticelli, you said there were 44,000 overdose deaths. I want
people to understand, that's more than died in Vietnam in
combat. I don't know that the American public understands that.
And every day on the news, NBC or whatever, they had body
counts and they had that, and people were outraged over that.
I'm not getting the sense of outrage over every year we
lose as many people to drug overdose as we did in a 10-year war
in Vietnam. I'm concerned when I had affirmed that in West
Virginia, one in five babies born in West Virginia, and I'm
sure it may be one in four in other States or so, but one in
five babies, they've been affected with drugs. I keep thinking
this in perspective by saying in Europe, the overdose rate is
approximately 21 per million; in America, it's seven to 10
times that amount.
Now, I get a little on the verge of outrage. You know, I'm
the father of four and grandfather of six, and I see these are
what we're giving our kids, this is what the future is. And I
hear this testimony from this panel of seven and the seven
before that and the seven before that, and quite frankly, I get
confused, because I don't known what the priority is.
From the business community and you all here in Washington,
everyone loves to plan, but they don't carry out. Now, that may
be insulting, and I don't mean it in an insulting fashion, but
we still have 44,000 people who will die between now and next
year because we don't have a prior--I'd like to think that we
could come up with one plan, one way, if you had at least one,
prioritize it, what's the one thing, and then let's put
everything we have into it, that Manhattan-type project, go
after that one solution and see if that doesn't start the ball
rolling in the right way, and then we can do two, three and
four with it, but a focus; but I don't see a focus. I didn't
see a focus from you. I heard seven, eight different ways that
we might be able to approach this problem, because the
planning--everyone loves to plan, but the implementation falls
short.
So, since you're meeting on a regular basis, couldn't you
come up with one--one idea to where we ought to begin to where
we can really--the metrics, we get the optics and everything,
we can really dig into that, and then we can have plan B, C and
D, but let's achieve one instead of continuing to melt down as
we do at this. I don't want to see another statistic of 44,000
more people die of overdose.
So I hesitate to ask, can you come up with an idea today in
the time frame, is there one, just one idea that we should
focus on? What's the best way? Is that in the drug use, is that
in real-time on purchasing the prescription drugs that it's a
national database, is that the number one thing we should do? I
mean, my God, the Federal Government just changed the
sentencing guidelines for heroin and they said if you're caught
with 50 hits of heroin, you get probation. What are we doing?
Are we fighting heroin or not? I'm really frustrated with this,
so I really--give me some more guidance on plan one.
Mr. Botticelli. So, Congressman, I appreciate your
attention to this. And, you know, myself and many of our
colleagues have been doing this work for a long time and, I
think, are filled with a sense of tragedy in terms of where we
are, and know that we can do better and know that we can work
with Congress.
You asked for one. I think there are three areas, and some
of these are articulated in the Secretary's plan, that we've
got to do. We've got to change prescribing patterns in this. We
are prescribing way too much medication, and that's starting
the trajectory. We need to increase our capacity to treat the
disease so that people who go down that path have adequate
access. And the third is that we really need to focus on
reducing overdose deaths.
Those are three areas that I think we can work with
Congress on to really look at how do we increase our efforts.
Dr. Frank. Let me add on to that on behalf--it seems that
people from West Virginia all sort of think alike that way. And
our Secretary, who shares the same experience you do has pushed
us to focus and to take action in those three areas. And, you
know, with it--this year we more than quadrupled our funding in
those areas, and we're going to triple that again if our plan
goes through, and these are in those three focused areas,
because that's where the evidence says we should be doubling
down, and that's sort of what is guiding us.
Mr. Murphy. Thank you. Is the Secretary asking for
legislation on this, then, to facilitate the answer to that
question?
Dr. Frank. There are some legislative proposals, and some
of it is just increasing some of the use of our discretionary
funds, and we got some additional appropriations this year, and
then in the President's budget, we have sort of some
legislative proposals for----
Mr. Murphy. Could you please let this committee know if
there's enabling language we have, and that would help address
Mr. McKinley's question?
Dr. Frank. Yep.
Mr. Murphy. Thank you.
Ms. Clarke of New York, you're recognized for 5 minutes.
Ms. Clarke. I thank you very much, Mr. Chairman, and our
ranking member, and thank you to all of our witnesses for
giving the committee the benefit of your expertise and
experience today.
I'd like to focus my questions on the prevention side of
the equation, how do we prevent opioid addiction in the first
place. So, Dr. Volkow, picking up actually on a point that Mr.
Botticelli made just a moment ago about way too many
prescriptions, this is to you: Why are so many prescriptions
being written for opioids? Are physicians not getting the
appropriate level of training and education in pain management
for responsible opiate prescribing practices? What would you
say?
Dr. Volkow. There are both. Actually, what had happened is
we have to recognize that there's another epidemic, of chronic
pain in our country, estimated at 100 million people, according
to the Institute of Medicine. As a result of the pressure of
needing to address this problem, the joint accreditation
require that hospitals and physicians in hospitals ask
questions about pain and treat them. This was in 2000. And the
problem was that that was not associated with the education
required in order to be able to properly screen pain, but also
to manage it, and to manage it and use opioid medications
adequately. So there was a big gap between the need to
implement better treatment for pain, but an inadequate
education of that system, so that is a major problem.
I think that in terms of prevention, we have to recognize
two aspects of this epidemic that are different from the
others. One of them, we do have individuals that start
diverting and they get the medications because they want to get
high, but then there's the other element that is as important,
of individuals that are properly prescribed the medication
because they have pain. And in the past, it was believed that
if you got an opioid and you had pain, you would never become
addicted. Now the data shows us that that's not correct. We
don't exactly know what percentage of individuals that will be
treated for their pain will become addicted. The range goes
enormously from none to something like 40/60, so we have no
real idea. And that's why I highlighted the notion of, we need
to be very aggressive in the education of healthcare providers
on the screening and management of pain, but also be very
aggressive on the education of healthcare providers for the
recognition of substance abuse disorder so that they can
determine who's vulnerable, and when a person that's properly
being treated is transitioning, and how to intervene.
Ms. Clarke. Very well. Thank you very much.
Director Botticelli, does ONDCP believe that the Federal
Government should mandate continuing medical education on
responsible opioid prescribing practices as a precondition of
DEA registration to prescribe controlled substances? And can
you elaborate on how that would work if that's the case?
Mr. Botticelli. Sure. We do support mandatory prescriber
education. I think for all of the evidence that you've heard
today, it's very clear that if we really want to prevent both
prescription drug misuse and heroin use and overdoses, we need
to stop prescribing these medications so liberally.
There was a recent GAO report that showed that physicians
get little to no pain prescribing, and actually veterinarians
get more pain prescribing than physicians in the United States.
So we don't think that it's overly burdensome to require
physicians in this epidemic to have education.
I think, as you talked about it, we'd have to work with the
legislature to look at changes to the Controlled Substances Act
to ensure that a certified continuing medical education program
would be linked to the DEA licensure or relicensure process,
and that we would oversee those courses that we believe have
the core competencies that we think are important and monitor
who takes those.
Ms. Clarke. Very well. Thank you very much.
Dr. Throckmorton, manufacturers of opioid pain relievers
are currently required to offer free voluntary education to
physicians or responsible opioid prescribing practices.
However, as I understand it, physician participation rates for
these voluntary educational courses are fairly low. Is that
correct?
Dr. Throckmorton. We do have those programs in place. They
were put into place about 18 months ago, and so the initial
year was spent putting into place a process to allow the
education to be available, prescribers to make use of it.
During that time, we saw about 20,000 prescribers that are
using extended-release, long-acting opioids sign up for one
course. That's true, 20,000 out of 320,000 prescribers that
prescribe these medicines is not a large fraction. It is
progress. What we hope is in the second year, which will end in
July of this year, we'll see a larger increase in terms of
uptake and use of this education. We have been working with the
continuing education community to make better use of it, make
it more available. We're optimistic. We hope that we'll see
more use.
It's one of two pillars of education, from our perspective.
Combined with the mandatory education that Mr. Botticelli just
spoke about, we believe both of these things provide important
opportunities to educate prescribers.
Ms. Clarke. Very well. I yield back. Thank you very much.
Mr. Murphy. Thank you.
Mrs. Brooks of Indiana, 5 minutes.
Mrs. Brooks. Thank you, Mr. Chairman, for continuing the
focus on this critical subject for our country.
I want to start with you, Dr. Volkow. We talked about how
the opioid addiction facing the country is, in large part, due
to chronic pain. And you mentioned that 100 million people
suffer from chronic pain. I've heard up to one in three
Americans actually possibly suffer from chronic pain.
And one of the goals of this hearing is to try to focus on
evidence-based treatment and new treatments in trying to find
out what it is that is working. And, obviously, one treatment
doesn't work for everyone, as we've heard.
But I learned about, in the course of examining this, that
there are some technologies that are new, not completely new,
but one being--I was told about spinal cord stimulation, which
targets nerves with electrical impulses rather than drugs, and
that clinical studies have shown it to be safe: 4,000 patients
have received this stimulator. And so it obviously is a device,
a technology that can actually stop that stimulation and can
help hopefully end that addiction, but yet NIH hasn't included
that in its draft pain strategy. It didn't mention technologies
like SCS.
Can you talk at all about why it wouldn't be promoting this
FDA-approved type of technology? And are there other
technologies we ought to be talking about other than medication
for chronic pain?
Dr. Volkow. Yes. Thanks for the question.
And this is an area that is rapidly evolving. And if it's
not mentioned, it's because many of the findings are way too
recent. And the one that you're commenting on in terms of
stimulation is one of the strategies in which we're also
promoting research. And the same strategy can be utilized to be
able to actually inhibit the emotional centers of the brain
that react to pain.
So researchers are utilizing a wide variety of tools and
technologies that have evolved as part of our initiative to
understand the brain. That, again, highlights--but it brings up
something that, I think, is facing us in this epidemic: the
need that we have to develop better strategies for the
management of chronic pain, because the physicians are forced--
patients in great suffering, they don't know what to do, and
they give an opioid even though the evidence does not really
show us they are very effective for the management of chronic
pain. But there are not many out there.
So recognizing that this is an area where we are required
to invest resources for having alternatives for patients
suffering from chronic pain is an extremely important part of
an initiative of addressing the opioid epidemic.
Mrs. Brooks. How would you recommend we increase, then,
patient access and educate more physicians about this type of
technology?
Dr. Volkow. Well, this is a new technology, some of them.
Actually, the evidence is just emerging. It will have to be
submitted to the FDA for approval. And then physicians, as part
of their training, should be exposed to them. And I would say--
I am just highlighting in the notion because Michael Botticelli
very clearly delineated, I also think it's important that
medical students, as part of their basic training, have an
understanding of these technologies because pain is part of
every medical condition, almost of every medical condition.
Mrs. Brooks. Thank you very much.
I'd like to ask you, Mr. Botticelli, my State, State of
Indiana, recently passed a law allowing physicians to prescribe
the naloxone to parents and to others and friends, giving them
greater access to the reversal heroin drug.
Would you speak as to what's known about the impact of the
naloxone programs and whether you have concerns about whether
the naloxone might encourage actually more risk-taking? Because
I met with law enforcement who said they had given naloxone,
had saved their lives and, a couple weeks later, saved their
life again with the naloxone. And so I am somewhat concerned--
and I absolutely want to save lives, and we must. And we know
there aren't enough treatments. This is obviously a huge
problem.
But might that encourage an addict, if they knew their mom,
dad, or friend had the save right there? Can you talk to us
about these naloxone programs?
Mr. Botticelli. Sure. So, to your first question,
obviously, naloxone distribution by as many people who have the
potential to witness an overdose is particularly important. And
law enforcement, particularly in rural counties, also play a
key role in that effort.
I will tell you, by way of--when I was in Massachusetts, we
significantly increased access to naloxone and actually did a
peer-reviewed study that showed when you introduced naloxone
into a community, overdose rates go down. And the more naloxone
you introduce, the better the scale effect.
You know, one of the pieces that we are concerned about--
but there is absolutely no evidence to show that naloxone
distribution actually increases drug use. Some of the issues
that you mentioned become critically important, that overdoses
are often seen as a significant motivator for people to seek
care. But having treatment on demand is a particular issue.
Treatment on demand, particularly in some of our rural
communities, is particularly an issue.
Interventions that are emergency departments to get people
into care become critically important. So while we know that
addiction is a chronic disease, and some people do continue to
use, when you have these adverse events, but we also need to
know we have to have a comprehensive response, not just saving
someone's life.
Mrs. Brooks. Thank you. I completely agree, and I certainly
hope the results in Indiana prove out to be the same as in your
State.
And I yield back. Thank you.
Mr. Murphy. Gentlelady yields back.
Mr. Mullin from Oklahoma, you're recognized for 5 minutes.
Mr. Mullin. Thank you, Mr. Chairman.
Before I get to some questions, I have got a followup
question for Ms. Hyde. The last time that you were in front of
this committee, which I really appreciate you coming back, we
had discussed your Web sites and if they were an effective use
of taxpayer dollars. At that time, you stated that you were all
in the process of evaluating that. Have you finished that
process yet?
Ms. Hyde. That process continues. Thank you for asking the
followup question. The process continues. I think the Web site
that you indicated most concerns about was one of the Web sites
that we were in the process of reviewing. It was originally
developed based on data and knowledge from NIDA.
Mr. Mullin. Right. And which----
Ms. Hyde. And we have----
Mr. Mullin. Well, that was for the 3- to 6-year-old for
suicide prevention. Have you finished that one yet?
Ms. Hyde. Yes. Building blocks----
Mr. Mullin. Right.
Ms. Hyde (continuing). I think is the one you were
concerned about. We have worked with our colleagues at NIDA and
determined that the Web site hadn't been updated in a while, so
it needed to be updated. So we have taken it down and are in
the process of updating it.
Mr. Mullin. Could you give me some process reports on that,
just so I can kind of know where you guys are at? We just want
to make sure that taxpayer dollars are being used in an
effective way.
Ms. Hyde. Certainly.
Mr. Mullin. To get to the questions, Dr. Throckmorton, just
a simple yes or no. Does the FDA recommend that methadone be
used as a first line of therapy for chronic pain?
Dr. Throckmorton. Methadone is approved for use for pain,
yes.
Mr. Mullin. But I am specifically speaking to the first
line, for a first line of defense, basically.
Dr. Throckmorton. It's one of the medications that we have
approved for pain. I will say, however, that if you look at
methadone, if you look at the labeling that we have for
methadone, it calls it out as far as a product that has
particular characteristics that make it challenging to use for
pain.
Mr. Mullin. So that would be a no for the first line.
What is your recommendation for first line?
Dr. Throckmorton. Our recommendation is prescribers think
very carefully before using methadone. There are things that
make it a challenging product to use. It is approved for use in
that setting, but I hope doctors think very carefully before
they do it.
Mr. Mullin. Well, the FDA put out a warning about the drug
safety and basically said that you guys--that insurers should
not--should not be referred as a preferred therapy, unless
special instructions and education was put onto it. So I would
take that as the FDA would, by this statement, that it'd be a
no, that you wouldn't recommend it unless there's a lot of
consideration taken.
Dr. Throckmorton. Personally, what I just said is where I
would be.
Mr. Mullin. OK.
Dr. Throckmorton. I need to look at the statement and get
back with you about the specifics of it.
Mr. Mullin. OK.
Dr. Throckmorton. But it is a drug that has a very long
half life that is variable patient to patient. It has unique
cardiac toxicities. There are other drugs that are useful for
pain that don't have those characteristics and I----
Mr. Mullin. Sure. All I'm really looking for is a yes or no
because I'm really trying to get further on down the line for
questions. I do appreciate you being here. And I like the last
name; that's my sister's last name. And I got some beautiful--
--
Dr. Throckmorton. A very good last name.
Mr. Mullin. I know. I've got three beautiful nieces. But
the spelling usually gets messed up.
Dr. Houry, what about the CDC? Do you guys consider this
methadone as being a first line of defense for pain?
Dr. Houry. At CDC, we just focus really on the primary
prevention and not as much of the care, so I would defer to the
sister agencies on that.
Mr. Mullin. Which would be?
Dr. Houry. The panelists here. FDA.
Mr. Mullin. Well, Dr. Throckmorton kind of gave his
personal opinion. But the statement of FDA you heard about. So
would you follow the statement, I'm assuming?
Dr. Houry. I would follow his statement. I don't have a
personal opinion on methadone for pain. It's not something I
did in my prior practice.
Mr. Mullin. OK. Dr. Conway--by the way, I'm always jealous
when people have their family with them. I have got five
wonderful kids. And if you ever want to see me cry, that's
about the only thing that will make me cry. I miss them.
Mr. Murphy. How are your kids doing?
Mr. Mullin. Thanks. I appreciate that. I will take a deep
breath and wipe the tear away.
Are you aware that methadone accounts for 30 percent of
overdose deaths while only accounting for about 2 percent of
the prescriptions that are prescribed for chronic pain?
Dr. Conway. I am aware that it's a higher percentage of
deaths compared to prescriptions because of the long half-life
and risks described.
Mr. Mullin. Would you personally recommend it as a first
line of defense for pain?
Dr. Conway. So I'm a practicing physician. I do not, as a
practicing physician, typically use methadone as a first
defense. However, I think it depends on the individual patient
characteristics and would defer to the physician's judgment
with that individual patient.
Mr. Mullin. Well, according to the Pew research, they put
out a deal that said methadone is available in low-cost generic
form and is considered a preferred drug in many States by the
Medicaid programs, despite FDA warnings about the drug safety
and the statements by the American Academy of Pain Medicine
that insurers should not be preferred this therapy unless it's
especially educated and provided to the individual.
I just kind of wonder if--overall, I would think, we're
considering it not being there. Why is this still listed as a
first line with Medicaid, I mean, when we're seeing so many
deaths? It almost makes you think, is the cost of a life not
more valuable than the cost of a low drug?
Dr. Conway. So I'd make a few points. Statutorily, the
Medicaid programs have the ability to set their preferred drug
list. However, we have taken a couple of actions that I think
to try to address this issue. One, working with SAMHSA, NIH,
and others on this panel, we have put out an informational
bulletin to the Medicaid programs talking about this issue and
a complete array of pain, both on the medication side, the
risks of methadone, and the other options and, also,
importantly as others have said, the importance of both
behavioral treatment and medication treatment.
I'd also call out, in our Medicaid Innovation Accelerator
Program, the first area we're working on is substance abuse
disorders. We have over 30 States involved, and they're taking
a comprehensive approach to the Medicaid program to appropriate
substance abuse treatment, including appropriate use of
medications and also other therapies.
Mr. Mullin. Dr. Conway, appreciate it.
Mr. Chairman, I yield back.
Mr. Murphy. Mr. McKinley has a followup question. Then I
have a followup question, too.
Mr. McKinley. Thank you for the opportunity just to follow
up because one of the questions or statistics I was giving you
in talking about prospector is the model or the situation that
they're facing in Europe. What do we have there in Europe? The
average is 21 per million. And I was just looking at--that's
the average.
Italy is below that. Latvia, Netherlands, Belgium, Greece,
France, Poland, Portugal, Bulgaria, the Czech Republic,
Slovakia, Hungary, Turkey, Romania, all have less than that,
significantly less. What are they doing right? What are they
doing differently in Europe than we are in America? Are we
learning anything from them?
Dr. Volkow. There is something that we're doing very
differently. And, actually, you picked up exactly on the point.
If you look at the United States, for some of the medications
we may be consuming 95 percent of the total production in the
world.
So the question is, Are we a Nation that is so much in pain
that we require these massive amounts of opiate medications? Or
is there something that we are doing in terms of their access
to them that is inadequate?
And I want, again, to reiterate the notion that, yes, we
are overprescribing opiate medications, on the one hand. But,
at the same time, which is not exclusionary, sometimes we are
undertreating patients with pain. So we are in a situation that
we have it bad in both ways. Overprescribing, making these
drugs available, which then can be easily diverted, and
prescribing them to those that don't need them can also result
in adverse consequences. You don't see that level of
prescriptions in any of the European countries.
Mr. McKinley. So what's the--why not? What are they doing?
Are their doctors more sensitive to this issue than our doctors
in America? Are they concerned about the trial lawyers? What's
the difference between it?
If there are 10 to 15 times more people dying in America
than there are in Europe, something is wrong. They're doing
something differently, and I'd like to know what it is.
Dr. Volkow. And that's exactly the way that I say we have
to aggressively institute the education of the healthcare
providers on the proper screening and management of pain--
that's a crucial component--while also educating them about the
adverse effects as it relates to substance abuse disorders.
And we need to face the fact that we need to also provide
alternative treatments for the management of chronic pain that
are effective.
Mr. McKinley. OK.
Yield back.
Thank you very much for that.
Mr. Murphy. Ms. Brooks, you have a quick question?
Mrs. Brooks. Thank you. Actually, I realize Mr. Botticelli
mentioned it in his opening, and I wanted to have an unrelated
follow-up if I might, Mr. Chairman.
Mr. Murphy. Yes, you may.
Mrs. Brooks. You mentioned--and we are having a crisis in
Indiana in Scott County, a community of 4,300 people, an
outbreak of HIV due to needle exchange. And I would simply
like--and I hope that many of you have been following what has
been happening and the number of citizens in Indiana who now
have contracted HIV because of their, in all likelihood, heroin
addiction, right.
Mr. Botticelli. Prescription drug.
Mrs. Brooks. Or prescription drug addiction and possibly
heroin addiction as well.
I am very curious, since I have this incredible panel of
experts here, what you might say to our State and to the health
professionals, our public health professionals who are dealing
with this crisis, to our State and local government officials,
what advice and thoughts do you have for our State? And I
truly, if we could, this is a crisis in our State that I think
could be in any State in the country.
Mr. Botticelli.
Mr. Botticelli. Sure.
Mrs. Brooks. And then anyone else who might comment,
please.
Mr. Botticelli. So, first of all, just about the staff from
all of the agencies on this table coordinate on a daily basis
in tight coordination with the Indiana Health Department to
make sure that we are giving Scott County the resources they
need to do that.
Mrs. Brooks. Thank you. And I'm sure Dr. Adams appreciates
that.
Mr. Botticelli. You're absolutely right that while we're
seeing huge--I think we're over 145 cases of HIV now--one of
the consequences we've seen nationally is increases in viral
hepatitis as it relates to sharing needles. And I think it also
points to some issues that we need to include about access to
treatment services.
So I think what's happening in Indiana in Scott County is
emblematic of the potential that we could see in other parts of
the country but points to some of the issues that we've been
talking about today in terms of making sure that people have
access to good care, both infectious disease care and substance
abuse care; they have adequate access to clean syringes so that
they are not increasing infection in this most poignant case of
what we need; and that they're having timely access to
treatment services, I think, are all areas to do that.
We'll continue to engage with folks in Scott County to make
sure that whatever we can do on the Federal side can help
alleviate the situation.
Dr. Houry. And I'd just like to add to that I'm really
proud of all of the efforts CDC is doing on the ground in
Indiana and in conjunction with agencies here, I agree
completely with Director Botticelli about the access to
medication-assisted treatment as well as the HIV therapy.
The other thing I would add is Indiana is number nine in
the Nation for prescribing, and so there's a lot that can be
done when you're looking at, again, trying to stop the epidemic
before it even happens. So looking at, again, using the
Prescription Drug Monitoring Programs, having better
prescribing guidelines, so that people don't get addicted to
opioids, then inject them. So that's the third component, I
think, we really need to add.
Mrs. Brooks. Dr. Volkow----
Dr. Volkow. Yes.
Mrs. Brooks. Or, I'm sorry, and Administrator Hyde. Maybe
Dr. Volkow and then Administrator Hyde.
Dr. Volkow. I mean, we got caught by surprise with the
Indiana epidemic of HIV, and I heard Tom Frieden say this is
the fastest growing incidence of HIV cases that we've had since
HIV entered the United States.
But there's been an extraordinary advance on HIV that has
emerged really over the past 2 or 3 years, which is that if you
initiate someone on antiretroviral therapy, not only are you
going to be improving their outcome, but you are actually going
to dramatically decrease their infectivity.
So, in looking forward--one of the things I would have
suggested to do is once you start to see a case, you
immediately treat them with antiretroviral therapy. They'll do
better, and their infectivity will dramatically decrease. So
this is another aspect, which actually relates to the issue of
giving good infectious disease care to these individuals
jointly with the interventions for substance abuse treatment.
Mrs. Brooks. Thank you.
Ms. Hyde. So I just wanted to add that we are working
collectively on this issue and that we understand there may be
some legal barriers that we've been talking to Indiana about in
terms of developing opioid treatment programs, and there's not
a lot of waivered physicians able to provide buprenorphine. I
think the closest opioid treatment program is about 40 miles
away. There may be some transportation barriers and some cost
barriers and other things. So we're collectively working with
the State to try to help develop alternatives.
Mrs. Brooks. Thank you, Mr. Chairman, for allowing me to
give that voice.
Mr. Murphy. Thank you.
I have two quick followup questions. First, Ms. Hyde, last
week, the subcommittee heard testimony from Dr. Anna Lembke,
the program director of the Stanford University Addiction
Medicine Program that the 42 CFR part 2 is an artifact of the
past. She told us the law's consent requirements are so
stringent that two doctors seeking to treat the same patient
for opioid addiction can't communicate with each other about
the patient's medical condition. In fact, she cited that the
subcommittee--and we received subcommittee reports. The rule
was based upon a 1972 law, and it's causing havoc in the age of
electronic records. I guess sometimes the police would actually
raid a methadone clinic and arrest people there.
So she has strongly recommend that we change that so we are
not overprescribing people and a physician can know who is in
treatment.
Now my understanding is that SAMHSA is contemplating new 42
CFR part 2 rules. And I just want to know if you're committed
that these rules will reflect the concerns that have been
repeatedly voiced by so many in the medical community who treat
patients with substance abuse who want nothing more than to
make sure patients aren't given double doses, so they can
really communicate. Is that what SAMHSA is going to be working
on?
Ms. Hyde. I really appreciate that question. It is a
complex issue. And you're right; these laws and regs are
decades old, before we had electronic health records, before we
had collaborative care models and other things that we are now
considering part of the practice.
We, a couple of years ago, put together some subregulatory
guidance to try to help this issue, but that wasn't sufficient.
So, last year, we held a listening session for stakeholders and
have taken those pieces of input and are trying to balance the
privacy concerns with the need for access to data. We hope that
we will have something available for public input yet this year
to try to address some of these issues.
Mr. Murphy. And please let the committee know. Thank you.
And, Mr. Botticelli, I wanted to follow up on this Kentucky
drug court issue. Could the drug courts' decisions relate to
the issue of diversion? I mean, at a previous hearing, we heard
testimony from witnesses that Suboxone mills are popping up in
Kentucky and West Virginia and these are high problematic
States. And, when entering the drug court system, it's nearly
impossible to determine if the Suboxone is from an illicit
source or prescribed by a doctor.
Could this be part of the issue and that the drug courts
could really work and perhaps have some flexibility to deal
with this on a case-by-case basis?
Mr. Botticelli. So I think there are a number of issues.
The National Association of Drug Court Professionals actually
did a survey of drug courts in the United States. And for those
drug courts that were not referring, it was actually more about
judicial bias than it was about fear of diversion that kept
people from doing that.
I think the second piece that any treatment, whether it's
medication-assisted treatment or residential treatment,
requires a level of collaboration and relationship between the
court and the provider to ensure that courts who are referring
to treatment are referring to high-quality treatment.
You know, we do need to pay attention to diversion. And
drug courts, I think in combination with treatment programs,
can ensure that these are appropriately prescribed and
appropriately monitored medications. And they need to make sure
that they're partnering with physicians who are implementing
and dispensing medications in a high-quality way.
Mr. Murphy. Now, part of this--I just got an article that
was--I'm not sure what newspaper it is. But it was talking
about in some of these courts, they're using Vivitrol and for
people in and out of incarceration trying to keep them off by
maintaining Vivitrol.
So I just want to make sure I understand. They want to keep
these people, after they're released from prison, drug-free.
And so could you please clarify: Are you saying that unless
they have some synthetic opiates, they're going to have Federal
funding cut, or they can still maintain Federal funding and
then Vivitrol would be acceptable as another part of the
program?
Mr. Botticelli. So we don't dictate to drug courts what
medications. That actually should be a decision between the
treatment provider and the patient.
I think our work here was just to make sure that there
weren't categorical prohibitions for drug courts either to not
offer medication-assisted therapies and, if someone was on a
recommended course of treatment, that they not have to get off
the medications to do that.
We actually don't dictate what medications courts use to be
able to do that. I think, like any treatment, you want to have
an arsenal of medications.
Mr. Murphy. Dr. Frank, could you also respond to the
Vivitrol question, too? Did you hear that? I'm just wondering
as that as an option for States as a diversion to be using
Vivitrol, that that could be part of what we could be----
Dr. Frank. Well, I think that we are trying to have the
full armamentarium available to the treating providers who are
trying not to get between the provider and the patient as long
as there is the opportunity to offer the richest menu of
evidence-based treatments that are available.
Mr. Murphy. Mr. DeGette, do you have a followup?
Ms. DeGette. Mr. Chairman, Mr. McKinley asked the witnesses
what one thing would you recommend that we could do to try to
start reversing this epidemic and this problem. He got as far
as Dr. Frank when he ran out of time. So I just ask unanimous
consent, if we can ask each one of the other witnesses----
Mr. Murphy. Yes, please.
Ms. DeGette (continuing). To supplement their testimony.
They don't have to say it right now.
Mr. Murphy. Get back to us. Thank you.
Ms. DeGette. But if you can get back to us with that
recommendation. We recognize there is a problem, and we are
really struggling with the issue of what we do as a Congress to
remedy it. Thank you.
Mr. Murphy. And I think what you're also talking about, a
partnership with the States--says we should be looking at
Kentucky and some others--Indiana----
Mrs. Brooks. Indiana.
Mr. Murphy (continuing). Colorado, of course, and see what
else is going on.
I want to thank this panel. We will follow up with the
questions because we heard a number of recommendations from
you, so we will ask for more clarifications of this.
Look, I want to thank you. As I said last time, too, you
know, if this was about a single airplane crash, this room
would be filled with media. But we have had more people die in
the last year from drug overdose deaths than the combination of
every airplane crash in North America from 1975 to the present.
And we have to make sure we keep this on the front page. This
is a serious crisis and one, whether it's education of
physicians, mandatory education, whether it's options out
there, we want to make sure the evidence-based care and that
Federal funding is going in the right direction.
So I'd like to thank all the witnesses and members that
participated in today's hearing.
I remind members they have 10 business days to submit
questions for the record, and I ask that all the witnesses
agree to respond promptly to the questions.
With that, this committee is adjourned. Thank you.
[Whereupon, at 12:20 p.m., the subcommittee was adjourned.]
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