[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
EXAMINING LEGISLATIVE PROPOSALS TO COMBAT OUR NATION'S DRUG ABUSE
CRISIS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
__________
OCTOBER 8 & 20, 2015
__________
Serial No. 114-86
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, California7
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota
Subcommittee on Health
JOSEPH R. PITTS, Pennsylvania
Chairman
BRETT GUTHRIE, Kentucky GENE GREEN, Texas
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
H. MORGAN GRIFFITH, Virginia BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida KURT SCHRADER, Oregon
BILLY LONG, Missouri JOSEPH P. KENNEDY, III,
RENEE L. ELLMERS, North Carolina Massachusetts
LARRY BUCSHON, Indiana TONY CARDENAS, California
SUSAN W. BROOKS, Indiana FRANK PALLONE, Jr., New Jersey (ex
CHRIS COLLINS, New York officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
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OCTOBER 8, 2015
Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 2
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 3
Prepared statement........................................... 4
Hon. Susan W. Brooks, a Representative in Congress from the State
of Indiana, opening statement.................................. 6
Hon. Joseph P. Kennedy, III, a Representative in Congress from
the Commonwealth of Massachusetts, opening statement........... 7
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 72
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 72
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, prepared statement........................ 73
Witnesses
Michael P. Botticelli, Director, National Drug Control Policy,
Executive Office of the President.............................. 9
Prepared statement........................................... 11
Answers to submitted questions \1\........................... 98
Richard Frank, Ph.D., Assistant Secretary for Planning and
Evaluation, Department of Health and Human Services............ 24
Prepared statement........................................... 26
Answers to submitted questions............................... 99
Jack Riley, Acting Deputy Administrator, Drug Enforcement
Administration................................................. 35
Prepared statement........................................... 37
Answers to submitted questions \1\........................... 110
Submitted Material
H.R. 2536, the Recovery Enhancement for Addiction Treatment Act,
\2\ submitted by Mr. Pitts
H.R. 3014, the Medical Controlled Substances Transportation Act
of 2015, \2\ submitted by Mr. Pitts
H.R. 3537, the Synthetic Drug Control Act of 2015, \2\ submitted
by Mr. Pitts
H.R. 2872, the Opioid Addiction Treatment Modernization Act, \2\
submitted by Mr. Bucshon
H.R. ___, the Improving Treatment for Pregnant and Postpartum
Women Act of 2015, \2\ submitted by Mr. Lujan
H.R. ___, the Co-Prescribing to Reduce Overdoses Act of 2015, \2\
submitted by Mr. Sarbanes
H.R. 2805, the Heroin and Prescription Opioid Abuse Prevention,
Education, and Enforcement Act of 2015, \2\ submitted by Mrs.
Brooks
Statement of the American Association for the Treatment of Opioid
Dependence, October 8, 2015, submitted by Mr. Bucshon.......... 74
----------
\1\ Mr. Botticelli and Mr. Riley did not answer submitted questions for
the record by the time of printing.
\2\ Legislation referenced in the hearing has been retained in
committee files and also is available at http://docs.house.gov/
Committee/Calendar/ByEvent.aspx?EventID=104047.
Letter of October 7, 2015, from James L. Madara, Executive Vice
President and Chief Executive Officer, American Medical
Association, to Hon. Charles W. Dent, a Representative in
Congress from the Commonwealth of Pennsylvania, submitted by
Mr. Pitts...................................................... 78
Letter of October 7, 2015, from Grant Smith, Deputy Director,
National Affairs, Drug Policy Alliance, to Mr. Upton and Mr.
Pallone, submitted by Mr. Green................................ 79
Letter of October 7, 2015, from Mr. Murphy, et al., to Hon.
Sylvia Burwell, Secretary, Department of Health and Human
Services, submitted by Mr. Murphy.............................. 94
OCTOBER 20, 2015
Witnesses
Paul K. Halverson, Ph.D., Dean, Richard M. Fairbanks School of
Public Health, Indiana University.............................. 112
Prepared statement........................................... 114
Chapman Sledge, M.D., Chief Medical Officer, Cumberland Heights
Foundation..................................................... 119
Prepared statement........................................... 121
Answers to submitted questions \3\........................... 231
Robert Corey Waller, M.D., Chair, Legislative Advocacy Committee,
American Society of Addiction Medicine......................... 128
Prepared statement........................................... 131
Answers to submitted questions............................... 232
Kenneth D. Katz, M.D., Section of Medical Toxicology, Department
of Emergency Medicine, Lehigh Valley Health Network............ 155
Prepared statement........................................... 157
Answers to submitted questions............................... 237
Allen F. Anderson, M.D., President, American Orthopaedic Society
for Sports Medicine............................................ 166
Prepared statement........................................... 168
Answers to submitted questions............................... 241
Submitted Material
Statement of Sandra D. Comer, Ph.D., President, College on
Problems of Drug Dependence, submitted by Mr. Pitts............ 188
Letter of October 20, 2015, from Jon Taets, Director, Government
Affairs, National Association of Convenience Stores, to Hon.
Charles W. Dent, a Representative in Congress from the
Commonwealth of Pennsylvania, submitted by Mr. Pitts........... 195
Letter of September 24, 2015, from Daniel E. Cooper, M.D., to Mr.
Pitts and Mr. Green, submitted by Mr. Pitts.................... 196
Letter of October 14, 2015, from Chuck Canterbury, National
President, National Fraternal Order of Police, to Hon. Charles
W. Dent, a Representative in Congress from the Commonwealth of
Pennsylvania, submitted by Mr. Pitts........................... 199
Letter of October 20, 2015, from Larry Langberg, President,
Society of Former Special Agents of the FBI, to Hon. Charles W.
Dent, a Representative in Congress from the Commonwealth of
Pennsylvania, submitted by Mr. Pitts........................... 201
Statement of the American Medical Association, October 8, 2015,
submitted by Mr. Pitts......................................... 202
Letter of September 16, 2015, from Michael J. Gerardi, President,
American College of Emergency Physicians, to Hon. Charles W.
Dent, a Representative in Congress from the Commonwealth of
Pennsylvania, submitted by Mr. Pitts........................... 208
Letter of October 16, 2015, from the American Association of
Orthopaedic Surgeons, et al., to Mr. Upton, et al., submitted
by Mr. Pitts................................................... 209
Letter of October 19, 2015, from Michael C. Barnes, Executive
Director, and Karen L. Thurman, Senior Government Relations
Advisor, Center for Lawful Access and Abuse Deterrence, to Mr.
Pitts and Mr. Green, submitted by Mr. Pitts.................... 211
----------
\3\ Dr. Sledge did not answer submitted questions for the record by the
time of printing.
Statement of the American Academy of Physician Assistants,
October 20, 2015, submitted by Mr. Pitts....................... 213
Statement of the National Association of Chain Drug Stores,
October 20, 2015, submitted by Mr. Pitts....................... 216
Letter of October 20, 2015, from David E. Nichols, Ph.D.,
Department of Medicinal Chemistry and Molecular Pharmacology,
College of Pharmacy, Purdue University, to Mr. Upton and Mr.
Pallone, submitted by Mr. Sarbanes............................. 229
EXAMINING LEGISLATIVE PROPOSALS TO COMBAT OUR NATION'S DRUG ABUSE
CRISIS--DAY 1
----------
THURSDAY, OCTOBER 8, 2015
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:16 a.m., in
room 2322 Rayburn House Office Building, Hon. Joseph R. Pitts
(chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Guthrie, Shimkus,
Murphy, Lance, Bilirakis, Bucshon, Brooks, Green, Engel,
Butterfield, Sarbanes, Matsui, Lujan, and Kennedy.
Also present: Representative Tonko.
Staff present: Clay Alspach, Chief Counsel, Health; Gary
Andres, Staff Director; Karen Christian, General Counsel;
Noelle Clemente, Press Secretary; Carly McWilliams,
Professional Staff Member, Health; Katie Novaria, Professional
Staff Member, Health; Graham Pittman, Legislative Clerk; Chris
Sarley, Policy Coordinator, Environment and the Economy;
Adrianna Simonelli, Legislative Associate, Health; Sam Spector,
Counsel, Oversight and Investigations; Heidi Stirrup, Policy
Coordinator, Health; John Stone, Counsel, Health; Eric Flamm,
Democratic FDA Detailee; Waverly Gordon, Democratic
Professional Staff Member; Tiffany Guarascio, Democratic Deputy
Staff Director and Chief Health Advisor; Una Lee, Democratic
Chief Oversight Counsel; Samantha Satchell, Democratic Policy
Analyst; and Kimberlee Trzeciak, Democratic Health Policy
Advisor.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. The subcommittee will come to order. I believe
the clock is a little slow, so we will get started.
And I want to start by mentioning we have a couple of
distinguished alumni in the audience of this committee. Phil
Gingrey, who was a member of our subcommittee, welcome. A very
distinguished member, Mary Bono Mack, is here. Where is Mary?
She often raised this issue with me. So welcome. We appreciate
all of your interest and input as well.
The Chair will recognize himself for an opening statement.
Today's hearing will consider a number of proposals intended to
address various aspects of our nation's drug abuse crisis. The
Oversight and Investigations Subcommittee has held five
hearings examining this public health epidemic and current
efforts underway to combat prescription drug abuse. It is clear
that, despite these efforts, the epidemic has continued to grow
exponentially.
Today is a good opportunity to better understand what
Congress can do to help. I appreciate the administration
witnesses being here and working with us on these complicated
issues. I also look forward to the testimony of outside experts
on these various bills in the near future. Prescription drug
abuse does not discriminate: it is not limited by geography,
income, or age. According to the National Institute on Drug
Abuse, one in five Americans has used prescription drugs for
nonmedical reasons.
In 2011, the Substance Abuse and Mental Health Services
Administration published a National Survey on Drug Use and
Health and found that 1.7 million 12-to-25-year-olds abused
prescription drugs for the first time, which amounts to more
than 4,500 new initiates per day. These startling statistics
should concern all of us. Unfortunately, only about 10 percent
of people with substance abuse disorders will get any form of
medical care. There are many of our constituents and their
families that still need help, and I applaud my colleagues for
working on legislation with that goal in mind.
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
Today's hearing will consider a number of proposals
intended to address various aspects of our Nation's drug abuse
crisis. The Oversight and Investigations subcommittee has held
five hearings examining this public health epidemic and current
efforts underway to combat prescription drug abuse. It is clear
that despite these efforts, the epidemic has continued to grow
exponentially.
Today is a good opportunity to better understand what
Congress can do to help. I appreciate the administration
witnesses being here and working with us on these complicated
issues. I also look forward to the testimony of outside experts
on these various bills in the near future.
Prescription drug abuse does not discriminate; it is not
limited by geography, income, or age. According to the National
Institute on Drug Abuse, one in five Americans has used
prescription drugs for non-medical reasons.
In 2011, the Substance Abuse and Mental Health Services
Administration published a National Survey on Drug Use and
Health and found that 1.7 million 12-to-25-year-olds abused
prescription drugs for the first time--which amounts to more
than 4,500 new initiates per day.
These startling statistics should concern all of us.
Unfortunately, only about 10 percent of people with
substance abuse disorders will get any form of medical care.
There are many of our constituents and their families that
still need help and I applaud my colleagues for working on
legislation with that goal in mind.
I will now yield to the distinguished gentleman from
Indiana, Dr. Bucshon.
Mr. Pitts. I now yield to the distinguished gentleman from
Indiana, Dr. Bucshon.
Mr. Bucshon. Thank you, Mr. Chairman. Congressman Womack
and I introduced H.R. 2872 as a starting point that will
eventually result in legislation that helps reverse the heroin
and opioid epidemic. Over 100 years ago, Congress first began
legislating opioid addiction treatment policies, and since that
time, Congress has had to come together and pass such
legislation time and time again. Given the worsening epidemic,
it is time for Congress to act once more.
H.R. 2872 is not a final product. To that end, Congressman
Womack, Congressman Tonko, and I held the first Opioid
Addiction Treatment Workgroup composed of the leading opioid
addiction professional associations and other stakeholders to
discuss our legislation. Our objective is to refine this
legislation to become a bill that all the key stakeholders
support.
We can only reverse the opioid epidemic by effectively
treating the underlying cause, and part of that underlying
cause is our Federal Government's public health response to
addiction. Clearly, what we are currently doing is not working
well enough, and change is needed. We will need to treat
addiction as the medical disease that it is, and confront the
very real issues that prevent a person from receiving
individualized care specific to his or her circumstances.
We need to understand what the data is telling us, and we
shouldn't allow the status quo to prevent a legitimate
deliberation over what is the best path forward for addressing
a crisis that is touching all of our communities. These are the
challenges that we must overcome.
[H.R. 2872 has been retained in committee files and also is
available at http://docs.house.gov/meetings/IF/IF14/20151008/
104047/BILLS-1142872ih.pdf.]
Mr. Bucshon. At this point, I also ask unanimous consent to
submit for the record a statement from the American Association
for the Treatment of Opioid Dependence.
Mr. Pitts. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Bucshon. Thank you, Mr. Chairman. I yield back.
Mr. Pitts. And I would like to ask unanimous consent to
submit the following document for the record: a letter from the
American Medical Association. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pitts. The Chair now recognizes the ranking member, Mr.
Green, 5 minutes for an opening statement.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Good morning, and thank each of you for being
here today. As we know, the Centers for Disease Control and
Prevention declared our nation's prescription drug abuse crisis
an epidemic. In 2013, drug overdose was the leading cause of
injury death in the United States. This is a battle we have
waged for more than 100 years. When Congress first passed laws
to confront the problems of heroin and opioid addiction, we
once again face the challenges of controlling and combating
this menace that is ravaging communities across the country.
In the past few years, overdose deaths involving opioids
increased fourfold and the number of heroin use has almost
doubled. Cases of HIV and hepatitis C are on the rise. Despite
universal recognition of the problem, our current efforts are
not enough to meet the challenges of the crisis. The drivers of
the problem are complex and there is no single silver-bullet
solution. It is critical that we approach this challenge
through a public health lens.
Experts have documented serious impediments to widespread
access to treatment, including a shortage of substance abuse
providers, social and cultural stigmas, and lack of health
coverage for such services. Current research suggests that a
combination of medication-assisted treatment and behavioral
treatment such as counseling and support services are the most
effective way to treat opioid addiction.
In 2013, medication-assisted treatments were available in
only 9 percent of substance abuse treatment facilities. For
example, in 2012, 96 percent of States and the District of
Columbia had opioid abuse dependence rates higher than their
buprenorphine treatment capacity rates. Thirty-eight States
reported that at least 75 percent of the opioid treatment
programs, also known as methadone clinics, were operating at a
greater-than-80-percent capacity.
Today, we are here to examine seven legislative proposals
aimed at combating our nation's drug abuse epidemic. They build
upon the hearings this committee has held and represent various
approaches to improving prevention and treatment. Each is a
product of thoughtful consideration and dedication from their
sponsors, and I thank my colleagues for their efforts and the
chairman for having this hearing. It is critical that we give
law enforcement, health providers, and communities enhanced
tools to address this epidemic. We need more resources and a
coordinated effort to ensure the evidence-based treatment is
available and diversion is stymied. The statistics are
staggering. The need for action is clear. Again, thank you for
being here.
[The prepared statement of Mr. Green follows:]
Prepared statement of Hon. Gene Green
Good morning and thank you all for being here today.
As we know, the Centers for Disease Control and Prevention
declared our nation's prescription drug abuses crisis an
``epidemic.''
In 2013, drug overdose was the leading cause of injury
death in the United States.
This is a battle we have waged for more than 100 years,
when Congress first passed laws to confront the problems of
heroin and opioid addiction.
We are once again faced with the challenges of controlling
and combatting this menace that is ravaging communities across
the country.
In the past few years, overdose deaths involving opioids
increased four-fold, and the number of heroin users almost
doubled.
Cases of HIV and Hepatitis C are on the rise.
Despite universal recognition of the problem, our current
efforts are not enough to meet the challenges of this crisis.
The drivers of the problem are complex, and there is no
single silver bullet solution.
It is critical that we approach this challenge through a
public health lens.
Experts have documented serious impediments to widespread
access to treatment, including a shortage of substance abuse
providers, social and cultural stigmas, and lack of health
coverage for such services.
Current research suggests that a combination of medication
assisted treatment and behavioral treatments--such as
counseling and support services--are the most effective way to
treat opioid addiction.
Yet, in 2013, medication assisted treatments were available
in only 9 percent of substance abuse treatment facilities.
We know there is a gap in the availability these
treatments.
For example, in 2012, 96 percent of States and the District
of Columbia had opioid abuse dependence rates higher than their
buprenorphine treatment capacity rates.
Thirty-eight States reported that at least 75 percent of
the Opioid Treatment Programs, also known as methadone clinics,
were operating at greater than 80 percent capacity.
Today, we are here to examine seven legislative proposals
aimed at combatting our country's drug abuse epidemic.
They build upon the hearings this committee has held, and
represent various approaches to improving prevention and
treatment.
Each is the product of thoughtful consideration and
dedication from their sponsors, and I thank my colleagues for
their efforts and the chairman for having this hearing.
It is critical that we give law enforcement, health care
providers, and communities enhanced tools to address this
epidemic.
We need more resources and a coordinated effort to ensure
that evidence-based treatment is available, and diversion is
stymied.
The statistics are staggering. The need for action is
clear.
Again, I thank you all for being here today and look
forward to examining the legislative proposals before this
subcommittee.
I yield the remainder of my time to my colleague from
Maryland, Representative Sarbanes, the sponsor of the Co-
Prescribing to Reduce Overdoses Act.
Mr. Green. And I would like to yield 1 minute to
Congressman Lujan.
Mr. Lujan. Thank you, Mr. Chairman and Ranking Member, for
scheduling this incredibly important hearing on a crisis that
is plaguing our nation. This crisis touches everyone, from
dense urban cities to rural States like New Mexico, for getting
access to health services can often be a challenge. Most recent
data from New Mexico's health department puts the accidental
drug overdose rate at 24.3 per 100,000. That is more than
double the national average. In two of the counties in my
district, the overdose rate is more than five times the
national average.
Too many people are being forgotten and too many people are
suffering. That is why I have introduced the Improving
Treatment for Pregnant and Postpartum Women Act to strengthen
efforts to ensure that some of our most vulnerable get the care
they need. I want to thank my colleagues, Representative
Matsui, Tonko, Clark, and Cardenas, for joining me in
introducing this bill, and I look forward to today's discussion
and getting this done. Mr. Chairman, the thoughtfulness behind
all of this legislation is so important, and I just hope that
we can get this done. Thank you, Mr. Chairman. I yield back.
[The bill introduced by Mr. Lujan has been retained in
committee files and also is available at http://
docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=104047.]
Mr. Green. Mr. Chairman, I yield another minute to
Congresswoman Matsui.
Ms. Matsui. Thank you very much. Thank you, Mr. Chairman,
for holding this hearing today on such an important topic.
There is a growing prescription drug epidemic plaguing this
country that we can no longer ignore. Prescription drugs are
the second-most abused category of drugs among young people,
and sadly, these painkillers often serve as a gateway to
cheaper street drugs like heroin.
The abuse of both prescription painkillers and heroin is
devastating families and undermining public health and safety
in our communities. In order to address this epidemic, we need
to engage the full range of players, including patients,
providers, parents, and manufacturers, as they all can and
should play a critical role in curbing the abuse of
prescription drugs.
Addressing this crisis should be a priority, and I am
pleased that this committee is holding a hearing on this
important issue. I look forward to hearing from other witnesses
as we consider strategies for addressing this epidemic. Thank
you, and I yield back.
Mr. Green. Mr. Chairman, I yield the remainder of my time
to Congressman Sarbanes, if he would like to make a very brief
statement.
Mr. Sarbanes. It will be brief indeed. Thank you for
yielding. One of the bills we are going to be talking about or
I will be referring to is the Co-Prescribing to Reduce
Overdoses Act. This would allow for co-prescribing of naloxone
when physicians are prescribing opioids in cases where the
patient is at high risk for overdose, and it would allow for a
demonstration project to support certain facilities in
exploring this opportunity, training physicians on it, who in
turn can train patients on how to self-administer this
lifesaving drug. We have an epidemic across the country.
Certainly, Baltimore, Maryland, is experiencing this, and we
look forward to testimony today on topics of this kind. And I
yield back. Thank you.
[The bill introduced by Mr. Sarbanes has been retained in
committee files and also is available at http://
docs.house.gov/meetings/IF/IF14/20151008/104047/BILLS-114pih-
Co-PrescribingtoReduceOverdosesActof2015.pdf.]
Mr. Green. Mr. Chairman, I would also like ask to place
into the record a statement by the Drug Policy Alliance.
Mr. Pitts. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pitts. The gentleman yields back. And now the Chair
recognizes the gentlelady from Indiana, Mrs. Brooks, who is
filling in for the chair of the committee.
OPENING STATEMENT OF HON. SUSAN W. BROOKS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF INDIANA
Mrs. Brooks. Thank you, Mr. Chairman. I would like to thank
the committee for bringing attention once again to this
important topic. Sadly, Indiana is leading the country but not
in a way we would like. Unfortunately, according to our State
Public Health Commissioner, Dr. Adams, Indiana is one of 13
States where the prescribers write enough prescriptions that
every citizen in our State has a paying prescription.
Unsuspecting addicts get hooked on opioids, but oftentimes,
they switch to heroin, not only for the high but because now it
is less expensive, and it is actually easier to get. And heroin
on our streets is cheaper, stronger, and thanks to the
synthetic add-ins, more unpredictable in its results than in
the past. From '99 to 2009 Indiana health officials have seen a
500-percent increase in the rate of drug overdose death, and in
fact, overdose deaths now surpassed motor vehicle-related
deaths in our State.
And it is not just the overdoses, but in this past year, as
this committee has already heard, Indiana has seen a drastic
spike in hepatitis C and HIV due to opioid and heroin
infusions, with the most recent figure at 183 confirmed cases
of HIV in one small rural county alone.
Now, we have held lots of roundtable discussions with
providers and with prescribers and with law enforcement, but
tragically, it is the families of the addicts and of those who
have died who have become the real experts in this field. The
consistent thread in the debate is that 80 percent of heroin
use starts with prescription for pain meds, and many
prescribers are unaware they may be a major part of the
problem.
So there is no silver bullet to fix it, but that is why I
am very pleased that Congressman Kennedy and I have introduced
H.R. 2805, the Heroin and Prescription Opioid Abuse Prevention,
Education, and Enforcement Act of 2015. Yes, it is a
comprehensive approach to solving the problem. It incorporates
law enforcement, medical providers, educators, and first
responders.
I am thankful to my colleagues for participating in today's
hearing and I look over to working with them in the coming
weeks to advocate not only for passage of this bill, but the
many thoughtful solutions being proposed by this committee. I
yield back.
[H.R. 2805 has been retained in committee files and also is
available at http://docs.house.gov/meetings/IF/IF14/20151008/
104047/BILLS-1142805ih.pdf.]
Mr. Pitts. The Chair thanks the gentlelady. And now the
Chair recognizes the gentleman from Massachusetts, Mr. Kennedy,
filling in for the ranking member of the full committee.
OPENING STATEMENT OF HON. JOSEPH P. KENNEDY, III, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF MASSACHUSETTS
Mr. Kennedy. Thank you, Mr. Chairman. I appreciate the
opportunity. And I want to thank the witnesses for coming to
testify today, and for your extraordinary dedication to these
issues and your service to our country.
The other day, I asked some of my constituents to tell me
about their experience with opiate abuse and drug addiction,
whether it was their own personal struggle or the battle of a
loved one. Their responses were heartbreaking: a grandmother
who lost her 25-year-old grandson over the summer, a father
whose 56-year-old son battled mental illness late in life and
eventually fell victim to cocaine addiction, a young woman who
just lost her cousin to an overdose 2 weeks ago, a mother whose
son was denied entrance into a treatment program last month
because he was already in detox after overdosing. So she gave
him the money he needed to buy drugs and test positive. The
themes of each story were unique, but every constituent ended
their message the same way, by calling on Congress to act.
Many of the bills we are considering today will help us
began to answer those calls, including one I was proud to
introduce with my colleague, Congresswoman Brooks, earlier this
year. Chairman Pitts and Ranking Member Green, thank you for
your continued commitment to this issue. I look forward to
listening to the conversation today and discussing some
bipartisan solutions.
I would like to yield the balance of my time to
Representative Tonko.
Mr. Tonko. And I thank the gentleman for yielding. I am
pleased that we are holding this legislative hearing today on
bills that aim to ease the burden of our nation's growing
opioid epidemic. I am here today in support of the Recovery
Enhancement for Addiction Treatment Act, also known as the
TREAT Act, on which I joined with my fellow upstate New
Yorkers, Representatives Higgins, Katko, and Hanna, to
introduce.
This legislation would lift the current caps in place on
the number of patients that doctors can serve while prescribing
buprenorphine, a medication-assisted treatment for opioid
addiction. Under current laws, if every opioid treatment
program and DATA 2000-waivered physician treated the maximum
number of patients, that would still be roughly 1 million
opioid-addicted individuals unable to secure treatment.
The hope with this bill is that we can lessen this gap
between individuals seeking treatment and our inadequate
treatment capacity. While this legislation is not a cure-all
and we still need to examine measures to ensure the highest
quality care, I believe the TREAT Act will go far in helping to
alleviate our acute treatment capacity issues and put more
people on the path to recovery. I urge our committee to take
swift action on this bill so that we can turn the tide on this
epidemic. And with that, I thank you and yield back to
Representative Kennedy.
Mr. Kennedy. Unless there is another member of the minority
that wants time, I yield back.
Mr. Pitts. The Chair thanks the gentleman. That concludes
the opening statements. As usual, all written opening
statements of the members will be made a part of the record as
well. We have two panels for this hearing. We are going to take
one today, the second, the week of October 20 when we come back
from break. But I would like to thank our first panel here
today, and I will introduce them in the order of their
testimony.
First, we have Mr. Michael Botticelli, Director of the
National Drug Control Policy, Executive Office of the
President; secondly, Dr. Richard Frank, Assistant Secretary for
Planning and Evaluation, Health and Human Services; and
finally, Mr. Jack Riley, Deputy Administrator, Drug Enforcement
Administration.
Thank you very much for coming today. Your written
testimony will be made part of the record. You will be each
given 5 minutes to summarize. We have a series of three little
lights. Green will be on for 4 minutes, yellow a minute, and at
minute number 5 the red will come on. We ask you to wrap it up
if you could, and then we will go to questions and answers. So
thank you very much for coming. And, Mr. Botticelli, you are
recognized for 5 minutes for your summary.
STATEMENTS OF MICHAEL P. BOTTICELLI, DIRECTOR, NATIONAL DRUG
CONTROL POLICY, EXECUTIVE OFFICE OF THE PRESIDENT; RICHARD
FRANK, PH.D., ASSISTANT SECRETARY FOR PLANNING AND EVALUATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND JACK RILEY, ACTING
DEPUTY ADMINISTRATOR, DRUG ENFORCEMENT ADMINISTRATION
STATEMENT OF MICHAEL P. BOTTICELLI
Mr. Botticelli. Thank you, Chairman Pitts, Ranking Member
Green, and members of the subcommittee, for the opportunity to
appear here today to discuss the administration's response to
the epidemic of opioid abuse, particularly the rise in
nonmedical prescription opioid and heroin use, overdose deaths,
and the use of new psychoactive substances.
The Office of National Drug Control Policy produces the
National Drug Control Strategy, which is the administration's
primary blueprint for drug policy. This strategy treats our
nation's substance use problems as a public health issue, not
just a criminal justice issue.
Using ONDCP role as the coordinator of Federal drug control
agencies, in 2011 our administration released a plan to address
the sharp rise in prescription drug misuse. This plan contains
items categorized in four areas: education of prescriber and
patients, increased prescription drug monitoring programs,
proper medication disposal, and law enforcement efforts.
The administration has also convened at Congress' urgence
an interagency Heroin Task Force co-chaired by ONDCP and the
Department of Justice to more closely examine our strategies as
it relates to heroin use in the United States. The task force
will release its strategic plan later this year.
There has been a stark increase in the number of people
using heroin over recent years and the number of overdose
deaths involving heroin. As communities and law enforcement
struggle with an increasing number of overdose deaths, heroin
use, and increased heroin trafficking, it is important to note
that plentiful access to opioid drugs via medical prescribing
and easy access to diverted opioids for nonmedical use is
feeding our opioid drug use epidemic.
Even though data indicate that over 95 percent of
prescription opioid users do not initiate heroin use, four out
of five new heroin users have experience as nonmedical
prescription drug users. Given this interrelationship, the
public health response to heroin use must be part of the
response to nonmedical prescription opioid use.
A further complicating factor in addressing this epidemic
is law enforcement reporting of heroin that is laced with
fentanyl, an opioid drug that is estimated to be 100 times more
potent than heroin. This increased potency has resulted in more
overdose deaths in many parts of the country.
We have seen overdose deaths from prescription opioid level
off, but unfortunately, this is coupled with a dramatic 39
percent increase in heroin-involved overdose deaths in 1 year,
from 2012 to 2013. To address the overdose death issue, we are
working to increase access to naloxone for first responders and
individuals close to those with an opioid drug use disorder,
and to promote Good Samaritan laws so witnesses to an overdose
will take steps to help save lives.
First responders nationwide are rising to this challenge of
addressing the increase in opioid use in overdose deaths, but
the medical establishment also needs to increase access to
treatment for individuals with opioid use disorders before they
become chronic or result in other public health consequences
such as infectious diseases or neonatal abstinence syndrome.
Given that little to no time in graduate medical education
programs is devoted to the identification or treatment of
substance use disorders and given that very few physicians have
availed themselves of voluntary training options, our
administration continues to press for mandatory prescriber
education tied to controlled substance licensure.
Evidence shows that medication-assisted treatment with FDA-
approved medications, when combined with behavioral therapies
and other recovery supports, has shown to be the most effective
treatment for opioid use disorders. Our administration
continues to pursue a wide variety of ways to increase access
to these lifesaving medications. But since some of these
products are subject to diversion, it is essential that this
expansion be done in a way that promotes high-quality care and
minimizes the opportunity for diversion.
It is also important to continue our efforts to educate the
public about the risks and consequences of nonmedical
prescription opioid and heroin use and the availability of
options for treatment for opioid use disorders to help improve
and save lives. To help with all of these efforts, the
administration's fiscal year 2016 budget proposal includes $133
million in new funding to reduce opioid misuse, abuse, and
overdose deaths.
Lastly, a few comments about the use of new psychoactive
substances, or NPS. The administration's activities to reduce
the use, availability of NPS include data collection, research,
prevention, treatment, domestic and foreign law enforcement
actions, and international cooperation to reduce the
manufacture and distribution of these serious life-endangering
substances.
The health risks of NPS can be significant, including
serious injury and even death. The contents and effects of
synthetic cannabinoids and synthetic cathinones are
unpredictable due to a costly changing variety of chemical
compounds used in manufacturing processes that are devoid of
quality control and regulatory oversight. These substances also
contain toxic impurity byproducts, and the potency can vary
significantly from batch to batch.
In conclusion, this administration will continue our work
with Congress and our Federal, State, and local partners on
public health and public safety issues resulting from the
epidemic of the nonmedical prescription opioid and heroin use,
as well as new psychoactive substances.
Thank you.
[The prepared statement of Mr. Botticelli follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentleman and now
recognizes Dr. Frank, 5 minutes for your summary.
STATEMENT OF RICHARD FRANK
Dr. Frank. Thank you, Chairman Pitts, Ranking Member Green,
and members of the subcommittee. I appreciate the opportunity
to speak with you about addressing the misuse and abuse of
opioids.
We at HHS share your sense of urgency to take action to end
this epidemic. Secretary Burwell has made halting the opiate
epidemic a top priority.
The numbers on the epidemic are stark. In 2014, more than
10 million people reported nonmedical use of prescription
opioids, and nearly a million reported use of heroin. Moreover,
it is estimated that more than 2 million people have an opioid
use disorder. These disorders tear apart families, increase
crime, and kill too many of our neighbors.
When Secretary Burwell arrived at HHS a little over a year
ago, she directed our senior leadership to develop and
implement an initiative to address the opioid problem. She
insisted that it be department-wide, focused, and evidence-
based so as to produce maximum impact. That effort resulted in
the strategy that consists of three elements: first, improving
prescribing practices for opioid pain medications; second,
expanding the use of medication-assisted treatment for opioid
use disorder; and third, expanding the use and distribution of
naloxone to reverse overdoses.
In the time I have with you today, I want to focus on our
efforts to expand the use of medication-assisted treatment, or
MAT. MAT is a treatment that combines medication, behavioral
interventions, recovery support services, and careful patient
monitoring. There are three FDA-approved medications used in
MAT: methadone, buprenorphine, and naltrexone. MAT, using each
one of these, has been shown to be effective in clinical trials
and in public health interventions. It is in fact the most
effective approach to treating opioid use disorders. Yet MAT is
woefully underused. Provision of MAT faces unique barriers in
part because methadone and buprenorphine are controlled
substances.
In addition, stringent medical management techniques are
used to control utilization, and in the case of buprenorphine,
the number of opioid use disorder patients a certified
physician can treat is limited to 100 at any one time.
Our approach to expanding the use of MAT is guided by,
first of all, the recognized need to expand the use of MAT;
two, the fact that effective use of MAT means delivering the
full package of services: pharmaceuticals, counseling, recovery
supports, and monitoring for a patient's adherence; and third,
that the capacity be expanded in a way that minimizes the risk
of drug diversion. This approach is supported by the American
Society of Addiction Medicine's recent guidelines on
appropriate use of MAT.
Given these guardrails, I want to share with you the steps
we are taking to expand MAT that we believe have much in common
with proposed legislation that has already been mentioned today
such as the TREAT Act.
Following Secretary Burwell's recent announcement, we are
engaging in rulemaking related to expanding access to
buprenorphine-based MAT. Our Health Resources and Services
Administration, or HRSA, recently announced a competition for
$100 million to expand the use of MAT in community health
centers. SAMHSA recently awarded $11 million per year for 3
years to 11 States across the Nation to increase MAT, and is
proposing an additional 25.1 million for this purpose to go to
22 States for fiscal year 2016.
CMS recently issued a letter to State Medicaid Directors
describing opportunities and authorities that States can use to
provide a continuum of care to beneficiaries suffering from
substance use disorder, including opioid use disorder.
We are also exploring ways to expand education and training
for providers in the treatment of opioid use disorders. We are
committed to tracking and evaluating our efforts, that we make
the best use of public resources, and in the end, we will
measure our success by the impact we have on families, people,
and communities touched by the opioid crisis.
Thank you.
[The prepared statement of Dr. Frank follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentleman and now
recognizes Mr. Riley, 5 minutes for your opening statement.
STATEMENT OF JACK RILEY
Mr. Riley. Chairman Upton, Chairman Pitts, Ranking Member
Pallone, Ranking Member Green, and members of the subcommittee,
I want to thank you for this opportunity to testify this
morning about our nation's most pervasive drug issues: the
continuing opioid epidemic and the rise of synthetic drugs.
DEA's single mission is enforcing the Controlled Substances
Act, and we are honored to work closely with our counterparts,
including those in education, enforcement, research, recovery
field, as well as partners in the supply chain.
Sadly, today, 120 Americans will die as a result of drug
overdose. Heroin and prescription drugs cause over half of
those fatalities. Accordingly, DEA views the opioid addiction
epidemic as the number one drug threat to our country.
I spent my entire career in law enforcement. Having been an
agent with the DEA for over 30 years, I have to tell you I have
never seen it this bad. Prescription drug abuse has increased
tremendously in the last 15 years. The abuse of prescription
drugs and resulting addiction has fueled a spike in the use of
heroin. In fact, four out of five new heroin users have misused
prescription painkillers.
Increases in heroin purity, its low cost on the streets,
the expanding role of violent Mexican organized crime groups,
and the toxic business relationship with violent urban street
gangs has also played a significant role in the resurgence of
heroin. DEA is addressing this evolving threat by targeting the
highest-level traffickers and the vicious organizations they
run.
I have personally spent the bulk of my career chasing the
man I consider to be the most dangerous heroin dealer in the
world, El Chapo Guzman. He and his Sinaloa Cartel clearly
dominate the U.S. heroin market, as the map I have brought with
me today depicts.
Just as we cannot separate violence from drugs, we cannot
separate controlled prescription drug abuse from heroin. As a
result, DEA established highly effective tactical diversion
squads, 66 in total, to target the critical nexus between the
diversion of prescription drugs and heroin. DEA has also
addressed the threat posed by the drugs that are in our
medicine cabinets through our National Take-Back, the latest
one being just 2 weeks ago. We have removed over 5-1/2 million
pounds of unused and unwanted drugs. However, DEA drug disposal
is still a problem to us and we can't solve it on our own.
DEA promulgated a regulation last year to allow the drug
supply chain to become authorized collectors. At present, we
have 500 registrants. It is simply not enough. This is one
important way in which we can step up as partners in our effort
to curb prescription drug abuse.
Lastly, I want to address the growing synthetic issue that
we are facing. Some of these designer drugs are referred to as
synthetic THC and marketed with similar effects. Nothing could
be further from the truth. Last year, there was a 229-percent
spike in calls to Poison Control Centers for synthetics. The
physical reaction to even one use of a synthetic drug varies
widely, and in some cases, has resulted in death.
DEA has identified literally hundreds of synthetic drugs
that have been encountered during Federal, State, and local law
enforcement operations. Manufactured in overseas laboratories,
these drugs are unregulated, have no medical use, and are not
tested for safety. This means that those who misuse these
products--most likely teens and adolescents--are really
unwittingly allowing themselves to become guinea pigs.
Law enforcement has been encountering these substances more
and more. According to the National Forensic Laboratory
Information System, substances identified as synthetic
cannabinoids by Federal, State, and local forensic laboratories
have increased from 52 reports in 2009 to over 49,000 reports
just last year.
DEA has made several enforcement operations targeting this
problem, including Operation Log Jam, Project Synergy I and II,
which have collectively resulted in 377 arrests and over $80
million in cash seized, and literally tons of synthetic drugs
taken off our streets. These operations demonstrate the scope
of the problem, but I believe they are really just the tip of
the iceberg.
I want to thank you for your partnership. DEA and I look
forward to continuing to work with this subcommittee and
Congress on these important issues.
[The prepared statement of Mr. Riley follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentleman. That concludes
the opening statements of the witnesses. We will now begin
questioning. I will recognize myself for 5 minutes for that
purpose. Dr. Frank, and then Mr. Botticelli, in your view, what
are the most significant obstacles at the present time
preventing more individuals with opioid use disorders from
receiving the most effective treatments?
Dr. Frank. I think there are several factors. I think
supply of treatment is certainly one important factor. The
second one is stigma and the shame that comes from seeking
treatment, the attitude of friend to neighbors. And then third,
I think we are still working on our payment and coverage
arrangements as we implement our parity legislation, and as we
move towards expanding our parity regulations.
Mr. Pitts. Mr. Botticelli?
Mr. Botticelli. As you indicated, only about 20 percent of
people who have substance use disorder get care and treatment,
and the factors that are often cited in those surveys, as Dr.
Frank alluded to, is, one, insurance status. And we know that
either not having insurance, or not having insurance that
appropriately covers a spectrum of substance use disorder
services is particularly challenging.
As he also talked about, stigma plays a role. We know that
in national data, and I hear it time and time again reflected
in people's stories, that it keeps them from asking for help,
or delaying their care.
And the third aspect, particularly as it relates to opioid
use disorders, as we have been discussing here, is the really
dramatic underutilization of medication-assisted therapies not
only in our treatment programs but in our correctional
facilities. We know we have many parts of the country that
don't have a dedicated treatment program, and looking at, and I
think particularly, the Secretary's initiative, focusing on
increasing access to community health centers--becomes
particularly important. So we know that not having dedicated
treatment in a local community is really, really important.
Mr. Pitts. Would the two of you expand on that, on the role
that you think medication-assisted therapy should play?
Mr. Botticelli. I will start and----
Mr. Pitts. Yes, go ahead.
Mr. Botticelli [continuing]. Have Doctor-- again, I think
there is common agreement and that all of the studies are
really very crystal clear that, by far, people with opioid use
disorders do better on medication-assisted treatment when done
in a high-quality way that includes other behavioral therapies
and supports, bar none. So we know that not only do people do
better, they don't die, they don't get infectious disease as it
relates to it. And part of our efforts on the administration
level, both at ONDCP in conjunction with HHS, is to ensure that
people have adequate access.
In addition to grants and other activities, we have also
been strengthening our Federal contracting language to ensure
that those programs that get Federal dollars that support
treatment include the entire spectrum of FDA-approved
medications for opioid use disorders.
Mr. Pitts. Dr. Frank, do you want to add to that?
Dr. Frank. The one point I would add to that is that it is
not only important that we have people out there able to
conduct medication-assisted treatment, but they have to do it
in a way that is evidence-based, that is, having all of the
components in place, the counseling, the recovery supports, the
patient monitoring. You need the whole package for it to work.
But clearly, when you have that, it is the most effective
treatment out there.
Mr. Pitts. Thank you. Mr. Riley, I appreciate DEA's
willingness to work with the committee to ensure that
veterinarians can travel with and administer pain medication to
their animal patients. Athletic team physicians also have an
inherently mobile practice, yet as was the case with the vets,
the statute prohibits them from administering appropriate
medication to their patients outside of their physical office.
Will you commit to working with the committee and Chairman
Sessions on a responsible solution to this important issue?
Mr. Riley. Well, yes, sir, we will and we are. This is a
difficult balancing act, in terms of making sure that the
supply is there to legitimate patients given by legitimate
caregivers, but we also want to make sure that the ability of
diversion in these situations are as limited as much. So I look
forward to working with the committee, and I know we already
are.
Mr. Pitts. Thank you. I also appreciate DEA's efforts to
combat the recent influx of incredibly dangerous synthetic
drugs hitting communities across the country, yet I understand
that due to no fault of your own, the criminals are a step or
two ahead of you. Can you explain how Congressman Dent's bill
would help in this regard?
Mr. Riley. Well, first of all, I want to say thank you to
the leadership in this issue because it really is an issue for
us. As I look across the country today, what keeps me up at
night is clearly the heroin issue, the opioid addiction issue,
various organized crime groups. But second that is the growth
of synthetic drugs primarily targeting our young people. I
personally witnessed this where people have lost their lives.
So from a cop's point of view, sir, and that is what I am,
anything that could help us as a tool to make sure we can move
quicker, we would welcome. And again, we are going to work with
the committee to get it done.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the ranking member, Mr. Green, 5 minutes for
questions.
Mr. Green. Thank you, Mr. Chairman. Current research
suggests that the most effective treatment to combat opioid
addiction is a combination of medication and counseling.
Methadone, which was approved nearly 50 years ago, is a
synthetic opioid. Methadone is also a DEA Schedule II drug.
Director Botticelli, could you talk a little bit about the
evidence base regarding methadone and how it impacts patients'
retention and treatment, transmission of infectious disease,
and other health outcomes?
Mr. Botticelli. So methadone is one of the most highly
evaluated treatments for opioid use disorders. It has been
around for over 50 years. And so not only have we seen kind of
remarkable results in terms of treatment engagement and
retention, and reduction in infectious disease but also
reduction in criminal behavior, increase in full-time
employment. It is one of the highly effective medications that
we have as it relates to opioid use disorders.
I think the bright spot that we do have with the opioid use
epidemic is a growing armamentarium of highly effective
medications, and when done in a quality way, methadone
treatment programs wrap not only medication but look at
addressing other medical conditions but also ensure that people
have access to behavioral therapies and other recovery
supports.
Mr. Green. OK. Dr. Frank, what are the advantages and
disadvantages of using methadone to treat opioid addiction?
Dr. Frank. Thank you for the question. As Director
Botticelli said, first and foremost, it is extraordinarily
effective, and that is a huge advantage. It is administered in
a highly structured environment that provides testing, support,
and therefore has a very low probability of diversion. Now,
this structured setting is there because of the way methadone
is metabolized, and careful attention to dosing is necessary
early in the treatment because of the increased risk of
mortality. And a disadvantage is that methadone is particularly
prone to stigma.
Mr. Green. OK. Another drug used for opioid addiction is
buprenorphine. This drug is a synthetic opioid and a DEA
Schedule III drug. Buprenorphine can be prescribed by
physicians who receive a DATA waiver. They are only permitted
to treat a maximum of 100 patients at a given time. Dr. Frank,
can you talk about the evidence base for buprenorphine and its
impact on overdoses and other health outcomes?
Dr. Frank. Yes, thank you. There have been 16 clinical
trials on buprenorphine. It is impossible to pronounce, isn't
it?
Mr. Green. Oh, it is very, although we are learning.
Dr. Frank. Buprenorphine----
Mr. Green. People who think Members of Congress can't learn
are so off.
Dr. Frank. So there have been 16 trials of buprenorphine-
based medication-assisted treatment. They consistently show
strong effectiveness in treatment retention and reduced illicit
opioid use. They also show improved maternal and fetal outcomes
in pregnancy, relative to placebo trials, and they also have
some mortality benefits. So they also have been highly
effective.
Mr. Green. I understand that an injectable drug called
Vivitrol also has been approved by FDA to treat opioid
addiction. Vivitrol is an opioid antagonist, meaning it blocks
opioid receptors. It is neither a narcotic nor a DEA-scheduled
drug. Director Botticelli or Dr. Frank, can you comment on the
evidence base regarding the use of Vivitrol in the treatment of
opioid addiction?
Mr. Botticelli. Once again, there is significant study to
show that injectable naltrexone is highly effective in terms of
dealing with opioid addiction. I think the premise here is we
have three really highly effective medications that are
underutilized. But it is also, I think, important to understand
that, as in any disease, you want as many highly effective
medications as possible, to make sure that we are matching the
right treatment with the right person, and that if one fails,
you have another option to be able to use for people. So, you
know, again, I think our approach is to ensure that people have
access to all of the three FDA medications that we have.
Mr. Green. Is there a problem with diversion of either of
those drugs? Because I know you said earlier in the testimony
that methadone wasn't a diversion on these two drugs?
Mr. Botticelli. You know, clearly, and I think it would be
disingenuous to say that there is not a diversion issue,
particularly with buprenorphine. However, what we see when it
is done in a high-quality way, when it is done with sufficient
patient monitoring, that it is particularly effective in terms
of the work that we see.
Mr. Green. OK. Mr. Chairman, finally, buprenorphine, I
think I can get that done.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the gentleman from Indiana, Dr. Bucshon, 5 minutes
for questions.
Mr. Bucshon. Thanks, Mr. Chairman. As background, I was a
practicing cardiovascular surgeon for 15 years, and my wife is
an anesthesiologist so I have a little bit of experience
prescribing and seeing patients on these medications. And now I
kind of get my medical knowledge through my wife, and as an
anesthesiologist, when patients come to surgery these days, it
is amazing the number of people who are already on prescription
narcotics for a variety of reasons, it is just striking, as
well as others like benzodiazepines. But we are addressing the
opioids today.
The other thing is this does go across socioeconomic class;
it goes across ages. For example, the number one prescribed
medication under Medicare Part D is a prescription opioid pain
medicine. That is seniors. So this is really a problem we need
to address, and it really is something that I am really happy
that we have chosen to have this hearing, amongst many others
today and in the past and future.
But enhanced provider education is another priority for
reversing the current epidemic--as a provider, I can say that
that is true--by really reducing inappropriate prescriptions of
opioids. So what steps should be taken to strengthen prescriber
training and primary care, outpatient opioid treatment, and
methadone clinics for the use of non-opioid methods of managing
pain, and also non-opioid things like Vivitrol and other
medicines in the recovery of opioid addiction? Mr. Botticelli,
you can start that.
Mr. Botticelli. Maybe I will start, and I will let Dr.
Frank talk about HHS efforts in this domain. As the
Congresswoman from Indiana pointed out, a 2012 study by the CDC
showed that we are prescribing enough pain medication in the
United States, not just in Indiana, to give every adult
American 75 pain pills. And while we clearly want to make sure
that pain is treated in the United States, when you look back
over the past 10 years, all of the morbidity and mortality is
directly correlated to the increase in prescribing. So we know
that giving people good education is important. That is why we
continue to pursue mandatory prescriber education. And I will
yield to Dr. Frank to talk about HHS efforts in those domains.
Dr. Frank. Let me mention four things that we think are
important. First is continue bringing prescription drug
monitoring programs into the clinical world so that we can
track prescribing patterns as part of routine medical practice
and can do so across States and across settings. That is one
thing.
Second thing is we are in the process of developing
guidelines for prescribing, particularly for non-cancer pain.
And we have accelerated that effort and should be putting those
guidelines out early next year. We have just had a set of
public meetings where we have rolled out some initial ideas and
gotten public feedback on it.
Third is we are engaging with a variety of medical
societies and specialty groups to find ways and to partner with
them to up the amount of training that is done within each of
their organizations. And then finally, for the second year in a
row, we have brought together the 50 States to compare best
practices for helping to improve prescribing and monitoring of
prescriptions.
Mr. Bucshon. And I think that is really important. I can
tell you in my own medical training in medical school and
honestly 7 years of residency, I never had a specific month or
week even directed at how to manage pain, and that is a person
who is a surgeon. So we really learn how to manage pain almost
on the go, so to speak, and I think addressing that issue
probably with accrediting agencies that accredit medical school
training or residency training is another avenue.
But I can tell you, as a physician, it takes months or
maybe even years to understand how to manage pain, whether that
is nonsurgical, whether that is related to injury, and top that
off with managing people that already have significant issues
with using prescription medication and trying to manage their
pain, that we clearly need to address training, probably all
the way back to medical school moving forward, and that may
take us a generation to fix. So I yield back. Thank you.
Mr. Pitts. The Chair thanks the gentleman, and now the
Chair recognizes the gentleman from North Carolina, Judge
Butterfield, 5 minutes for questions.
Mr. Butterfield. Thank you very much, Chairman Pitts, and
thank the witnesses for your testimony today. Let's see. Where
do I start? All of you are right. All of my colleagues are
right. All of the witnesses are right. We have a crisis in this
country, and it is preventable, in my opinion. And so it is
therefore incumbent upon all of us to address the opiate
epidemic that has claimed too many, too many victims in my
district and in your districts and all across the country.
Opiate addiction doesn't discriminate. It does not
discriminate. Black, white, rich, or poor, anyone can succumb
to opiate addiction. And that presents a very difficult
challenge to finding ways to curb the epidemic. My home State
of North Carolina has seen a 300-percent death increase due to
opiate poisoning since 1999. Our emergency officials where I
live in Wilson, North Carolina, respond to overdose calls every
other day on average. In March, police in the city of
Greenville, North Carolina, responded to six heroin overdoses
in a single day.
This is real. It is a real problem which reaches each and
every community in our country from the most urban to the most
rural and across every demographic. There is much that we can
and should do in response to this significant problem.
Recently, I received a letter from our attorney general, Mr.
Roy Cooper, and 37 other State Attorneys General urging Members
to support legislation to assist with recovery from opiate
addiction. One of the provisions important to my State included
in that legislation is funding to increase access to naloxone
for first responders. This drug is a lifesaving treatment which
can counteract some of the damages of narcotic overdoses.
And so I appreciate the convening of this hearing to
consider some of the policy options to combat this dangerous
national epidemic. While some of these pieces of legislation
are steps in the right direction, we must consider increasing
access to naloxone--and I may be pronouncing that wrong--for
law enforcement.
It is also clear that we cannot do this alone. The private
sector is a key stakeholder and is stepping up to the plate.
From abuse-deterrent formulations to injectable and implantable
treatments, the future of medicine can help reduce prescription
drug abuse and diversion.
But let me underscore the urgency of doing it now. From
2001 to 2013 there was a threefold increase in deaths from
opiates, and the doctors in the room, I appreciate you helping
to put a spotlight on this problem. There has been a threefold
increase in deaths from opiates. These are our nation's mothers
and fathers and sisters and brothers. This is a crisis. To
Director Botticelli, thank you for your testimony. Are abuse-
deterrent formulations having an impact here in the United
States?
Mr. Botticelli. One of the areas that we continue to
evaluate is how abuse-deterrent formulations will diminish
people's use. I think we are continuing to work with FDA to
look at the evaluation strategies. But clearly, we know that
this is a prime strategy that we have been putting forth in our
Prescription Drug Abuse Plan to really look at the impact that
abuse-deterrent formulations will continue to play in reducing
prescription drug use issues.
I think as you discussed that abuse-deterrent formulations
are one part of a larger strategy that we have to employ in
terms of dealing with this issue. Clearly, we don't want people
just switching from one drug to another. We want to use that as
an opportunity to get people into care and treatment. So this
is obviously a prime part of our strategy, an important part of
our strategy, but it has to be linked to other things to ensure
that people get interventions and get good, high-quality care.
Mr. Butterfield. While I have your attention, let me talk
about manufacturers just for a moment. Can you describe whether
we should be doing more to encourage opiate manufacturers to
convert their medicines to abuse-deterrent formulations?
Mr. Botticelli. And I probably can't speak as eloquently as
the FDA can on this issue, but clearly, they have signaled
their strong preference for approving abuse-deterrent
formulations as part of their overall goal and work that they
are doing. And again, it has been clearly part of our overall
prescription drug abuse strategy to continue to promote abuse-
deterrent formulations.
Mr. Butterfield. Thank you. Now, I will go to my far right.
And we don't use that word, do we? All right. Go to the right.
All right. Deputy Administrator Riley, as a representative from
an area which has withstood some of the strongest storms in our
nation's history, I am concerned. I am interested in the
Medical Controlled Substances Transportation Act of 2015. I
know you recognize that. Can you describe whether this
legislation would increase access of potentially lifesaving
treatments to those in need in federally declared disaster
areas?
Mr. Riley. Well, clearly, in situations unfortunately the
Carolinas are going through now----
Mr. Butterfield. Yes.
Mr. Riley [continuing]. It is an important aspect. While I
don't know the specifics of the bill, I can tell you that we
are working with the committee on this. We recognize this is an
issue that really needs attention, and I give you my word we
are going to come to some agreement here. We can work it out.
Mr. Butterfield. Mr. Chairman, you have been very patient
with me. Thank you. I yield back.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the gentleman from Florida, Mr. Bilirakis, 5 minutes
for questions.
Mr. Bilirakis. Thank you so much. I appreciate it. Thanks
for your testimony, panel. I have a question for Mr. Riley.
Recently, as many of you discussed in your testimonies, heroin
deaths have been increasing across the country at an alarming
rate, unfortunately. Both Pinellas and Hillsborough Counties in
Florida, which I represent--I represent a portion of both of
those counties--they have seen heroin deaths rise in some cases
by more than 700 percent over the course of a year.
Unbelievable. Mr. Riley, what can we do to best address not
only how to control the supply side of prescription drug abuse,
but also address the demand issue so that this population
doesn't turn to illicit drugs?
Mr. Riley. Thank you for the question, sir. Well, I think
you hit it on the head. While I have been in law enforcement
for 30 years, I do recognize we cannot arrest our way out of
this. This is an issue that can be found in every corner of
this country in cities large and small, rural and urban. And we
have got to get everybody's help, from law enforcement to
policymakers, to educators, faith-based organizations, clearly
treatment, and the registrants that handle prescription drugs.
So it is an educational fight as much as it is I think a law
enforcement fight.
Now, on the law enforcement side, I also have to tell you
we have never seen organized crime--and I will use the Sinaloa
Cartel. We have never seen in my 30 years a criminal entity so
well financed, vicious, and willing to do anything to make a
buck. What keeps me up at night, sir, is the growing
relationship between American street gangs, urban street gangs,
and the toxic business relationship that they have formed with
Mexican organized crime. That in itself I think has fostered
the spread of heroin across the country.
Today's heroin is not what it was 5 years ago. It is
cheaper, it is more pure, it can be smoked and snorted. So it
has really attracted a completely different user base. So
everybody in this room plays a role in our success, and that is
why I applaud this committee for even bringing this up.
But I can tell you DEA around the world, working with our
partners, it is the number one priority. One of the things that
we are doing better, sir, that we haven't done before, is we
are communicating. The bad guys for years have counted on the
cops not sharing information, not sharing intelligence
information. We are doing that better now than we have ever
done it, even with our foreign counterparts.
I have spent quite a bit of time on the border and also in
Mexico. I have to tell you we have never seen the exchange of
information with the Mexican law enforcement authorities as
good as it is. Our ability to share information and for them to
share information back for domestic cases is at an all-time
high. So I am optimistic on the law enforcement front that we
are moving forward. But clearly, everybody has a piece of this.
Mr. Bilirakis. Thank you. That is good to know. Mr.
Botticelli, you mentioned a steep rise in the number of babies
born with neonatal abstinence syndrome. Counties within my
district were found to be suffering from some of the highest
number of babies born addicted to opiates in the country. What
do you see as the greatest obstacle to ensuring access to
services, and how can these challenges be addressed?
Mr. Botticelli. So, again, this is, I think, an opportunity
for us to work with Congress on additional issues, particularly
the Protecting Our Infants Act that was passed in the House,
and I think it is a really great opportunity to expand our
efforts.
So clearly we, you know, as you have indicated, have seen a
dramatic increase in the rise of pregnant women and neonatal
abstinence among babies who are born here in the United States.
You know, obviously, our overall efforts to focus on reducing
prescription drug misuse and heroin use play a big role, but
also making sure that pregnant women have good access to care
and treatment, we have effective medications, again, for the
use in this and that moms have particularly good access to a
wide variety of treatment services. So this becomes really
important for us to look at this.
We also want to ensure that we are not putting additional
stigma on pregnant women in terms of their ability to seek
care, and we hear that time and again. Dr. Frank talked about
the role that stigma plays, but that is particularly true with
pregnant women, and we don't want to do anything to further
enhance that, particularly among pregnant women in terms of
their ability to seek care.
Mr. Bilirakis. Thank you, sir. Would you be willing to come
to my district and participate in a roundtable on this
particular issue?
Mr. Botticelli. Absolutely. I----
Mr. Bilirakis. I am in the Tampa Bay area.
Mr. Botticelli. Great. I would be happy to do that. I have
had the opportunity, as I have traveled, to talk and visit many
neonatal intensive care units, had the opportunity to talk to
practitioners. I think we have further work to do, and this is
where we are looking forward to working with Congress on making
sure that we have good standardized protocols for the treatment
of pregnant women, that we have good surveillance. And so
again, I think this is another area where administration
priorities and congressional priorities are aligned.
Mr. Bilirakis. Absolutely. Thank you very much. I yield
back, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the gentleman from New Mexico, Mr. Lujan, 5 minutes
for questions.
Mr. Lujan. Thank you very much, Mr. Chairman. I appreciate
this important hearing today. And, Mr. Chairman, my questions
began with Dr. Frank. Looking specifically at the legislation
that I have introduced, Assistant Secretary Frank, to see what
we can do in, especially rural States like New Mexico, where it
is hard to get to some of these areas and families are being
separated because of the challenges of substance abuse, which
is compounded by these distances and healthcare shortages, what
are we doing to ensure that those in need of help are getting
it? How do we make sure people don't have to wait 3 months to
be able to get access to this care? And how do we make sure
that rural communities are not left behind?
Dr. Frank. Thank you for that question. As you probably
know, Secretary Burwell, being from a rural area herself in
West Virginia, where the opioid abuse and mortality rates are
very high, is extraordinarily sensitive to these issues. And
one of the things that is behind our new grant program putting
$100 million into community health centers to increase access
to buprenorphine is to actually get more services, more people
trained into the areas of high need and low availability. And
so that is a major thrust of what we are doing there.
The other is to sort of revisit our rulemaking on access to
buprenorphine and other medication-assisted treatments so that
we can increase the number of doctors, potentially increase the
physician capacity to treat opioid use disorder.
Mr. Lujan. And, Dr. Frank, can you quickly touch on the
importance of how we should consider giving States flexibility
when it comes to treatment programs? There is a program in a
little community in my district in Espanola called Inside Out
that talks about the length of time that it takes to get
treatment. And many judges in New Mexico are requiring 6-month
treatment programs. There aren't very many 6-month treatment
programs, and the only ones available are if you get
incarcerated. So we are spending money to put someone in jail
and not putting that money into treatment for these individuals
that are addicts.
Dr. Frank. Yes, thank you for that question. Actually, I
have been there, and I think that it is important. And in fact,
the reason that we are using grant mechanisms is in part to
allow us to kind of match the interventions and match the
strategies to the local needs, and in particular, making sure
that the patient is at the center of what we do, and their
circumstances kind of dictate the way we put the treatment in
place.
Mr. Lujan. Inside Out also makes the important point, as we
have talked about, naloxone or Narcan, that -- what can we do
to make sure that that is readily available? It is about the
safest substance, as we talk about these treatments, that
someone can take. Is there a push or can Congress do something
to make that available over-the-counter, as opposed to not
being a prescription mechanism? Because of some of these
addicts, you know, when there is an emergency or an issue, you
have to go try to get a prescription. They need it then and now
to save their lives. What are your thoughts, sir?
Mr. Botticelli. As you indicated, increasing access to
naloxone by anyone who is in a position to reverse an overdose
has been a particularly important priority for us. We have been
working with law enforcement across the country, have really
been heartened to do that. We have been significantly heartened
by the number of States, including New Mexico, that have passed
naloxone distribution efforts.
We are continuing to support, and will in the President's
fiscal year 2016 budget, a naloxone purchase. SAMHSA sent out a
letter to States saying that some of the existing grant
structures can be used to support naloxone purchase. So that
will continue to be a priority for us to look at how we
increase the capacity for naloxone and look at supporting grant
programs to look at increased naloxone purchase.
Mr. Lujan. And, Mr. Riley, I am trying to do the math here.
Everything that I read suggest that 90 percent of the poppies
in the world are grown in Afghanistan, or the opioids are
produced in Afghanistan. So that leaves 10 percent for the rest
of the world, and it is grown in lots of places. Ninety percent
of the heroin coming to the United States is attributed to
Colombia and Mexico, with 50 percent going to one cartel. So am
I to understand that with less than 10 percent production, or a
fraction of that production, Mexico and Colombia are growing
their own poppies that lead to 90 percent of heroin that is
coming to the United States? Or is there opium coming from
Afghanistan to Mexico and to Colombia that is making its way to
the United States? And if that is the case, how do we stop it?
Mr. Riley. Well, I can tell you that the majority of the
opium and heroin produced in the Afghanistan theater is
destined for China, Russia, and Europe. We see as little as 5
percent in the United States. But clearly, between the
Colombians' criminal organizations and the Mexican criminal
organizations, they control virtually all of the heroin
available across our country.
And what are we doing to ensure that--I go back to the
cooperation that we have, sharing intelligence information,
making sure that we work on organizations. For us to be
successful, we have to stop the street level, which leads to
violence, but at the same time, we have to ensure that we
follow those cases wherever they take us, whether it is into
Central/South America, working with our counterparts overseas,
our agents on the ground to stop it at the source, and at the
same time, to go after the reason they are in business, and
clearly that is the profit. And that is just as important a
part of what we are doing. So are we getting better? I
certainly feel we are, but as I said before, this is a
marathon, not a sprint. We are in it for the long haul, but we
need everybody's help.
Mr. Pitts. The gentleman yields back. The Chair recognizes
the gentlelady, Mrs. Brooks, from Indiana, 5 minutes for
questions.
Mrs. Brooks. Thank you, Mr. Chairman. And thank you all for
your work on this issue. Mr. Botticelli, as I mentioned in my
opening and as you also talked about, we have an issue with
respect to the prescribing practices beginning with medical
school education, or not just with med schools because it is
not just physicians who are prescribers, there are a whole
category of healthcare providers who are prescribers.
In ONDCP's 2011 report 4 years ago, it was epidemic,
responding to America's prescription drug crisis, and one of
the issues in that report was that we were going to encourage
medical and health professional schools to continue expanding
their continuing education programs to include instruction on
measuring pain and prescribing to treat it. What efforts have
been made since 2011, if not before, with our medical education
schools? Because I talked to our med school in Indiana just a
couple of months ago and still yet less than 5 hours, if even 3
hours, of education is dedicated to those who are prescribing.
What is the resistance? Why are our medical education
providers, not just for physicians, but for nurses and for
nurse practitioners and others, what is the resistance, and why
haven't we gotten that done?
Mr. Botticelli. There are two issues that you and Dr.
Bucshon have articulated, and I think one is getting to the
root cause about how do we make sure that healthcare providers,
not just physicians but nurses, have embedded in their training
programs good information on substance use disorders and safe
prescribing? We have actually been working with the American
Board of Addiction Medicine and all of the specialty medical
societies and the AMA, as well as the deans of medical schools
to look at embedding good medical education as part of----
Mrs. Brooks. OK.
Mr. Botticelli [continuing]. Their curriculum.
Mrs. Brooks. Excuse me for interrupting, but why hasn't it
been done yet, when we have known for now a number of years
this has been a problem? You all identified it at least in
2011, if not before. What is their resistance in embedding it
in their curriculum this academic year? Why isn't it there yet?
And what do we need to do with our State medical
associations, with the medical school associations, and so
forth, what do we need to do to get it embedded in education
initially? Healthcare providers don't want to be helping cause
the problem, but yet when they give a 30-day prescription for a
pain med after a minor procedure when you might need 4 to 6 or
7 days--I don't know, I'm no doctor--why do we give 30 days of
prescription? Why are the med schools resistant?
Mr. Botticelli. Having been doing this for quite a while, I
think there has been just an overall hesitancy and resistance
to think about substance use disorders as part of someone's
overall health conditions, and not seeing the impact of what we
are seeing. You know, when we look at referrals to treatment,
only 7 percent of referrals to treatment are coming from our
healthcare providers. And I think we will continue to pursue
opportunities not just to embed medical education but look at
the testing requirements of those medical educations to make
sure that we are having competencies as part of medical
examinations.
And this is why I think, you know, being into this epidemic
why we have been calling at least for mandatory education. We
have seen States--about 10 States have passed medical education
laws as it relates to pain prescribing, and we are seeing some
remarkable results.
Mrs. Brooks. Excellent. Could you please provide us with
the list of which 10 States have done that? Because that is
something that I would like to explore further.
Mr. Botticelli. Happy to do that.
Mrs. Brooks. Mr. Riley, I want to thank you for your many
decades of service with the DEA. I am a former U.S. attorney
from 2001 to 2007. Crack cocaine was the epidemic of the day in
the '80s, '90s, and early 2000s, but it has obviously shifted.
And I am curious, because the synthetic drugs that are coming
into this country, you said in your written testimony, is
primarily from China. And while we have this unprecedented--I
am curious about the unprecedented cooperation with Mexico.
Really? I would like to know a little bit more about why is it
so much better now than it was 5 years ago? And how is China
cooperating with us with respect to synthetics?
Mr. Riley. Thank you, ma'am. In terms of China, we are
beginning to make inroads there. It has been a tough road. Many
of the synthetic drugs that are seized here are very difficult
to origin, and that is by design. But we have made inroads. We
have had several high-level meetings with the Chinese on this
issue, dating back, I think, several years ago. So this is an
ongoing dialogue.
Part of our issue there, as it has been in Mexico, is to
make sure both the Mexican authorities and the Chinese
authorities understand the damage that it is doing in the
United States. In terms of our Mexican partnerships, I was the
agent in charge of El Paso in the mid-2000s when Juarez was
aflame, thousands of drug-related homicides.
We have really developed a working relationship with part
of the Mexican authorities, not all of them, unfortunately. But
we have developed a working relationship that is based off
trust, that is based off productivity, and I think they
understand the importance that they can play, in both their own
country and around the world. Our extraditions continue to be
strong. Just a couple of weeks ago we were able to pull out two
very high-level targets that, I got to tell you, 5 years ago I
don't think they would have even consider doing it.
So it is an ongoing process, ma'am. It is what keeps me up
at night. I am really 35 years old, but this is what it has
done to me. And I give you my word, around the world, our guys
24/7 are on it, because it truly is the new face of organized
crime.
Mrs. Brooks. Mr. Chairman, before I yield back, I just want
to commend the agents of the DEA who I have worked with for
quite some time, and they do remarkable work. There just aren't
enough of them, and I don't think we give them all the tools
they need. And with that, I yield back.
Mr. Pitts. The Chair thanks the gentlelady, and now
recognizes the gentleman from Massachusetts, Mr. Kennedy, 5
minutes for questions.
Mr. Kennedy. Thank you, Mr. Chairman. Mr. Riley, a couple
of questions to start with. Mrs. Brooks and Mr. Lujan touched a
little bit on the origins of the opium trade and heroin trade
internationally, and I was wondering if you could quantify, to
the best of your ability, the total dollar figure, if you will,
between the U.S. and Mexico for heroin.
Mr. Riley. Well, that is very difficult to do, but I can
tell you it is in the billions.
Mr. Kennedy. Order of magnitude? Just so -- and I don't
mean to pin you down too much, but a billion, 10 billion, 100
billion?
Mr. Riley. Definitely close to 50 billion. And I quantify
that by saying just in Chicago, where I was the agent in charge
and heroin has exploded in the last several years, it was
billions of dollars when we really drilled down on it. And I
think that is what is really important. And if you look at New
England in particular, you are seeing this spread of violent
organized crime, urban, in terms of street gangs, and their
ability to interface almost as unwitting contractors with
Mexican organized crime to put heroin on the street, to make it
available and obviously causing violence. I mean, the way these
organizations regulate themselves, sir, is with the barrel of a
gun. And I think it has caused tremendous damage across the
country.
Mr. Kennedy. And, Mr. Riley, thank you, and thank you for
your service. I want to touch on two other things. I just
commend you briefly for bringing back, first off, the take-back
days, and one day back on April 26 of 2014 Massachusetts
residents alone, in a single day, dropped off nearly 23,000
pounds of drugs. And I believe nationally the figure was 390
tons in a single day. I think they are a tremendous asset for
our country, and I appreciate you bringing them back.
I also want to thank you for your work with New England
around the HIDTA designation, the high-intensity drug
trafficking area. It has helped with critical resources for law
enforcement in the region, and I want to thank you and commend
you for that.
Mr. Frank, I wanted to touch base with you a little bit if
I can somewhat briefly, my apologies. There are three FDA-
approved medications for treatment of opioid dependence:
methadone, buprenorphine, and naltrexone. I am interested in
learning a little bit more from you about methadone, if you
will. So could you describe a little bit about how methadone is
used to treat individuals with opiate dependence?
Dr. Frank. So methadone is a very powerful drug. It is a
controlled substance. It is provided in a very controlled
setting, so-called OTP, opioid treatment programs, that are
very comprehensive. They provide the dose in person on the day.
They provide counseling, they provide drug testing, they
provide patient monitoring. And I think I said earlier that the
reason that this is done is because the dosing and the
management of methadone, particularly at the beginning of a
treatment episode, must be done very carefully or risk
mortality.
Mr. Kennedy. And there are special restrictions on the
ability to prescribe methadone?
Dr. Frank. Yes, there is.
Mr. Kennedy. And what are they, briefly, if you can?
Dr. Frank. They have to be done within those programs,
those certified programs.
Mr. Kennedy. And are those requirements applied to
treatment of individuals with opiate dependence with naltrexone
or buprenorphine, or is the regulatory schema different?
Dr. Frank. Yes, the regulatory schemes are quite different.
The naltrexone sort of operates under the rules of DATA 2000
and -- did I say naltrexone? I meant buprenorphine. And
naltrexone is not a controlled substance, and so it can be
prescribed by any physician.
Mr. Kennedy. And is there a medical rationale to separate
the way that those drugs are actually regulated?
Dr. Frank. I think there is. As I said, I think there are
unique risks, in, particularly, the early stages of methadone
treatment. Buprenorphine, as we have noted, is a drug that is a
controlled substance, and there is diversion of that drug. And
because naltrexone is not a controlled substance, it can be
more broadly prescribed. So I think there is a logic to it.
Mr. Kennedy. So if I could squeeze one last question in
here, do you think -- does that separation of that different
regulatory environment make sense, or do you think bringing it
all together and putting it under one -- basically abolishing
the stovepipe regulations there makes sense, or is there
rationale for keeping them separate?
Dr. Frank. I think that even if you brought them together,
you would see many of the same restrictions in place. I think
that what we are trying to do is to particularly focus on
buprenorphine right now, because I think that is an opportunity
we have to rethink those rules so that we can expand access to
MAT.
Mr. Kennedy. Thank you very much, sir.
Thank you, Mr. Chairman. I yield back.
Mr. Pitts. The Chair thanks the gentleman. Because Dr.
Murphy is chairing a hearing downstairs, Mr. Guthrie is
yielding him his 5 minutes. Dr. Murphy, you are recognized.
Mr. Murphy. Thank you, Mr. Chairman. I appreciate that. I
wanted to be here because, although downstairs we are having a
hearing on Volkswagen and devices put in cars that affect
emissions testing, this is a life-and-death matter, so I wanted
to be here.
The first thing I wanted to ask, Mr. Chairman, I ask
unanimous consent that this letter, signed by multiple members
of the Energy and Commerce Committee, be submitted into the
record. It was sent today to HHS and calls for a comprehensive
review and additional rules on buprenorphine providers before
HHS unilaterally lifts the DATA provider cap.
Mr. Pitts. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Murphy. Thank you.
Now, I just want to make sure none of you are physicians,
none of you are people who are involved in the treatment of
people with addiction disorders. Am I correct?
Mr. Botticelli. [Nonverbal response.]
Dr. Frank. [Nonverbal response.]
Mr. Riley. [Nonverbal response.]
Mr. Murphy. OK. But you are involved with policymaking on
these issues, correct?
Mr. Botticelli. [Nonverbal response.]
Dr. Frank. [Nonverbal response.]
Mr. Riley. [Nonverbal response.]
Mr. Murphy. OK. I am a psychologist. I have dealt with
people with addiction disorders. And I want to start off by
saying one of the problems we have in this country is that
money that is sent to States that is being used for mental
health funding for block grants and substance abuse block
grants are not allowed to be used together. The serious problem
that comes with that is many people with substance abuse
disorders also have mental health disorders,, and yet we create
a barrier there.
Now, we are talking about increasing the number of
prescriptions a physician can write. Dr. Frank, do you know how
many--so we are talking about someone going from like 30 or so
a month, a week, a day? What is it? Up to----
Dr. Frank. Thirty patients at any one time.
Mr. Murphy. Up to 100, and they can potentially go beyond
that. Do you see a maximum with that?
Dr. Frank. Right now, there is a limit to 100 after a year.
Mr. Murphy. Right, but after that, they are looking to do
more, to lift that cap, right?
Mr. Frank. We are in the process of sort of reviewing the
best way to expand access, and we are going to do it very
cautiously.
Mr. Murphy. I understand that. To what number?
Dr. Frank. We don't have a number yet.
Mr. Murphy. OK. Now, throughout this process -- and you
recognize that buprenorphine is the third-most diverted drug.
That is people get it and they sell it, and they make money and
then they will go out and buy heroin or something else. What
attention is being given to make sure that doesn't happen?
Dr. Frank. That is exactly why we are taking a careful
approach, because of that concern. But let me give you an
additional concern. So we want to expand access. We are
concerned that too often you don't get the full package of
services, the counseling, the supports, and in the testing and
monitoring, and so we want to make sure that the evidence-based
package is in place and that the risks of diversion are
minimized. And so what we are trying to do is to collect
evidence about where are the places, and under what conditions
are you most likely to be able to significantly expand capacity
while minimizing the risks of diversion, and maximizing the
probability that evidence-based treatment will be provided.
Mr. Murphy. So let me ask about some of those. How much
time do you think the average amount of time is that one of the
physicians who is prescribing will actually be face to face
with a patient?
Dr. Frank. I think that----
Mr. Murphy. Well, let me put it this way: Is that something
that will be assessed?
Dr. Frank. Yes. Well, we want to consider sort of what it
takes and what are the environments that get you combination of
treatments, so that means you have to have the counseling, you
have to have the----
Mr. Murphy. Right. Well, let me go into just a couple
things. I talked to one clinic and they said the average amount
of time physicians may spend actually discussing and
prescribing is about one and a half minutes. Now, during that
amount of time, you have to assess those very things. Is this a
diversion issue? Is the person in recovery? Are they seeing a
counselor or therapist? Are they really engaged in treatment?
And also then in many of these cases the person who is
perhaps the addictions counselor does not even communicate with
the physician, except maybe to write a note in the chart in
treatment. Or they may have someone there in some places where
it is a nurse or someone sitting in the waiting room, and while
people are there waiting for their prescription, they have a
chat and they write that down as group therapy. You are aware
that some of these things take place. Knowing you, I would
assume you would be as distressed as anyone to say that is not
tolerable, that is not treatment. And such people not only
should not have expanded prescription privileges, they should
have zero.
Dr. Frank. I completely share your concerns, but even more
importantly, Secretary Burwell shares those concerns.
Mr. Murphy. Yes, she does.
Dr. Frank. And she has emphasized sort of a careful
approach to make sure that both the evidence-based treatment
and the risk of diversion are addressed carefully.
Mr. Murphy. One more final thing in my final seconds here,
I know Secretary Burwell is dedicated to this, too, but I am
also concerned that the amount of training that these
physicians get, deal with addictions, is minimal. Very few of
them are actually addictions counselors, addiction trainers,
and many times other people there have minimal training.
In my area of southwestern Pennsylvania I have heard
proctologists, plastic surgeons, pediatricians, and others who
do not have extensive board certification in these things. I
think it is a dangerous issue for something that is growing as
a deadly issue in America. And I hope we can continue our
conversation. I want to work with you on this, but we are all
concerned that just expanding the number of prescriptions can
be written without total assurances of other things is a
dangerous issue. Thank you. And I yield back.
Dr. Frank. And we thank you for your support and agree.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the gentleman from Maryland, Mr. Sarbanes, 5 minutes
for questions.
Mr. Sarbanes. Thank you, Mr. Chairman. I want to thank all
of you for being here today. I have introduced the Co-
Prescribing to Reduce Overdoses Act, which would create a
demonstration project to encourage co-prescribing opioid
overdose reversal drugs like naloxone.
So let me talk a little bit about the need first, which you
all are very familiar with. Over 100 Americans every day are
dying from preventable drug overdose, and that kind of fatality
is now the leading cause, the leading cause of accidental death
in the country. In 2013, more than 16,000 people died due to
prescription opioids overdose, and an additional 8,000 died
from heroin overdose. In Maryland, we are having the same
experience. We had 192 heroin overdoses in the City of
Baltimore, in Anne Arundel County, which I also represent.
There were 49 fatal overdoses from opioids, and that was part
of 360 overdoses overall that occurred.
So this is an epidemic. There is no question about it. And
we have to put real resources behind it. We have to put it
behind workable and strategic solutions that we can identify. I
will mention that, today, the State of Maryland released a
$680,000 grant from the U.S. Department of Justice to help
address this epidemic in our State.
Let me talk about naloxone now. It is a drug that safely
and effectively reverses both opioid and heroin-induced
overdoses if administered in time. It has been used by
nonmedical personnel with only minimal training for over 15
years and has been proven to reduce lower overdose mortality by
almost 50 percent. More people need access to lifesaving
medication, obviously.
And while efforts to distribute naloxone to first
responders and community organizations are important, and we
have talked about that today, it is critical that we also take
a more proactive approach. One idea, one part of that proactive
approach is the idea of co-prescribing naloxone to patients who
are taking opioids and are at high risk of overdose. And this
is supported by the American Society of Addiction Medicine, the
American Medical Association, the Veterans Health
Administration.
The bill that I have introduced, the Co-Prescribing to
Reduce Overdoses Act, would create a demonstration project for
federally qualified health centers, opioid treatment centers,
and other providers to encourage co-prescribing naloxone. Funds
could be used for training to purchase opioid overdose reversal
drugs, to offset copays, and to conduct community outreach and
raise awareness to connect patients who have experienced a drug
overdose with appropriate treatment, and track individuals that
are participating in the program. And all grant recipients, of
course, would be required to evaluate the outcomes of the
program.
A second program would allow States or local health
departments to develop guidelines on co-prescribing opioid
overdose reversal drugs like naloxone. So there is no question
that opioid overdose is a public health epidemic. I believe
strongly that increased access to naloxone, particularly this
co-prescribing opportunity to patients at high risk of
overdose, is a key element of any approach to successfully
decrease prescription drug and heroin overdoses.
I would like to get the thoughts of the three members of
the panel, certainly Mr. Botticelli and Dr. Frank, on this
question of whether co-prescribing naloxone is an effective
strategy that we should try to encourage and support going
forward.
Mr. Botticelli. Thank you for your leadership on this
issue. I don't think we could agree with you more in terms of
the opportunities that we have for supporting co-prescribing in
a wide variety of settings, and particularly for people who are
at highest risk.
We share your goals. We have actually continued to take
action to support co-prescribing. We have hosted webinars with
the American College of Emergency Rooms Physicians to support
co-prescribing. We continue to work with our treatment programs
to encourage co-prescribing. So this is, I think, a
particularly important area for people who are at high risk.
Our overall policy goals are to ensure that anyone who is
at high risk for an overdose also has access to naloxone. It
has been truly remarkable in terms of its ability to save lives
and actually motivate many people to go seek care and
treatment. So we would love to continue to work on that to look
at that legislation.
Mr. Sarbanes. Dr. Frank, I have 15 seconds if you have a
comment. Yes.
Dr. Frank. Yes. I obviously am not going to say what he
said, but there are some things that you need to do to go along
with co-prescribing and other measures to really expand supply
here, and one of them is making sure that we have user-friendly
versions of naloxone so that non-medically trained people can
administer it. Two, I think we need to make sure that once
somebody gets naloxone, they get the treatment. Just recovering
and walking away isn't the right thing to do. We have to get
them to see----
Mr. Sarbanes. No, it is the first step is what you are
saying.
Dr. Frank. It is the first step, and it is an important
first step----
Mr. Sarbanes. Yes.
Dr. Frank [continuing]. But we would like to complement
that with links to treatment.
Mr. Sarbanes. Great. Thank you. I yield back.
Mr. Pitts. The Chair thanks the gentleman. The Chair
recognizes Mr. Lance, 5 minutes for questions.
Mr. Lance. Thank you, and good morning to the panel. And,
Mr. Riley, did you say you are 35 years old? Is that what you
said?
Mr. Riley. Yes.
Mr. Lance. Yes, I am 35 as well, but what keeps me up at
night is leadership elections. You discussed challenges in
carrying out a criminal prosecution pursuant to the Federal
Analogue Act. It is my understanding that there is a very high
burden of proof to establish that a compound is in fact a
controlled substance analogue. Could you please elaborate on
that standard and what changes can be made to the Analogue Act
that would make it more effective as a tool in combating the
spread of synthetic drugs?
Mr. Riley. Well, first of all, just the mere amount of
these synthetic drugs that we are encountering is mind-
boggling, and our ability to test those through our scientific
arm and get an identifier on them sometimes is very prolonged.
So what we are doing now is we are really trying to look at how
can we be effective? What is the best possible way that we can
move this process along? But I have got to be honest with you.
We are not one step behind the bad guys, we are three steps
behind the bad guys.
Mr. Lance. Thank you. Is there anyone else on the
distinguished panel who would like to comment on this?
Mr. Botticelli. I completely agree. I think it has been a
challenge from both a prevention standpoint and a scientific
standpoint to stay ahead of the chemical tweaks that
manufacturers make to do that. I think that opportunities to
lower the burden of proof around scheduling, around these
analogues are important. I think despite Congress and States'
best attempts to deal with this issue, that look at expediting
the scheduling and thinking about the criteria with which we
schedule those drugs is particularly important.
Mr. Lance. Thank you. Director Botticelli, as you mentioned
in your testimony, New Jersey, where I live, is one of a
handful of States that requires greater use by prescribers of
the State's Prescription Drug Monitoring Program. Specifically,
Governor Christie recently signed into law a requirement for
prescribers to check the program and patients returned for a
second resale on a prescription opiate. What is your office
doing to ensure that both State officials and prescribers are
able to utilize effectively their Prescription Drug Monitoring
Programs?
Mr. Botticelli. So I will start, and I know that this is an
important initiative for the Secretary, too, so there is more
action.
Mr. Lance. Certainly.
Mr. Botticelli. When this administration started, we had 20
PDMP programs, 20 States. Today, I am happy to report that we
have 49 States that have Prescription Drug Monitoring Programs.
We continue to focus opportunities on increasing the interstate
operability so that we can share information across State lines
but also increase the utility and usability of these programs.
And I will defer to Dr. Frank on that.
But one of the things that I think we are seeing promising
practice, and particularly in States that require some level of
mandatory check of their Prescription Drug Monitoring Program,
we are seeing a decrease--in Florida, we saw a significant
decrease in overdose deaths, and we have seen a significant
decrease in doctor-shopping, people going from one doctor to
another to get their medications when we have good, robust
Prescription Drug Monitoring Programs.
Mr. Lance. Thank you. Dr. Frank?
Dr. Frank. Thank you. This here, we are investing $20
million in State grants really to focus on improving
Prescription Drug Monitoring Programs in the States. We have a
proposal in for 2016 to put in 45 million in order to bring it
to all 50 States. And we are hoping to build off the progress
of some very successful pilots in addition that have integrated
Prescription Drug Monitoring Programs in clinical health
information technology.
Mr. Lance. Thank you very much. And, Mr. Chairman, I yield
back the balance of my time.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the gentleman from New York, Mr. Engel, 5 minutes
for questions.
Mr. Engel. Thank you, Mr. Chairman. You know, gentlemen,
first of all, thank you all for excellent testimony. Really,
all of you have just been terrific. And, you know, through my
perch on the Foreign Affairs Committee when I was chairman of
what we called the Western Hemisphere Committee, which dealt
with Latin America, and we did a lot of work involving the drug
trade in Mexico and some of the other places. And we fund money
for treatment programs and we fund a lot of money to go after
the bad guys, but so much of the consumption comes from us that
I have always felt that we didn't do enough in terms of
education, and in terms of that side of it rather than going
after the bad guys after they have done it.
And the one thing that is stark for me is that there are so
many people in this country that use drugs. I mean it is just
mind-boggling. And young people, because when you are young,
you think you are going to live forever and you think nothing
is going to happen to you and so you are more likely to
experiment, but this is an epidemic. I mean, this is just
beyond the pale. You know, I don't make judgments on anybody,
but I just know that we can't continue like this. I mean, we
have got to do a better job of educating people and letting
them understand that this is a life-ruining situation.
And you have really driven the point home, all three of
you, about it. I mean I have some other questions to ask, but
in general, I think, you know, if you could expand on that
because it is really just shocking, the extent of the abuse.
And so not only are we keeping these criminal enterprises
going, but we are destroying lives of American citizens.
Mr. Botticelli. I will start. Thank you, Congressman, for
your comments. I think, yes, what you have described is the
entire approach, the Obama administration's view of drug policy
that, while supply reduction and law enforcement has a big role
to play, that we need and will continue to pay more attention
to prevention, treatment, and recovery efforts for people here
in the United States. If you look at our entire drug control
budget, we are actually spending now more on those public
health strategies than we have had during the entire time of
our office, so this is particularly important.
I will say, however, that I think our heroin situation is a
good example between the nexus of supply and demand, that
because of the purity levels, because of the price, because of
the widespread availability of heroin that we have, it really
does combine both a public health and public safety approach.
And I have really been heartened, as I travel around the
country, to see law enforcement and police wanting to partner
with public health to really come up with holistic strategies,
knowing that arrest and incarceration are really ineffective in
dealing with this issue.
Mr. Engel. You know, every time I see a young person smoke
a cigarette, a regular cigarette, I think to myself, you know,
why are they doing this? Because we have evidence now that we
didn't have maybe when I was a kid that regular smoke just is
terrible for your health. And you think, well, why would a
young person do that? We are not getting through. And of course
when you take it a notch up and you are talking about heroin or
prescription drugs, it is that much worse. So we are failing as
a society, and it is just shocking.
So let me ask you, Dr. Frank. The bill proposed by
Congresswoman Brooks and Congressman Kennedy tasks an
interagency coalition with developing best prescribing
practices, and it is certainly needed. My district -- New
York's Lower Hudson Valley contains a portion of my district,
and according to the New York State Office of Alcoholism and
Substance Abuse Services, the number of New Yorkers admitted to
hospitals on account of heroin skyrocketed 136 percent between
2004 and 2013, and in 2013 alone, nearly 90,000 New Yorkers
were admitted to hospitals for heroin and prescription opioid.
This is shocking. It is absolutely, absolutely shocking.
So given how varied the populations affected by this
epidemic are, how would you, Dr. Frank, suggest that we ensure
that any best practices created as a result of this bill or
other bills will suit physicians and patients from contrasting
backgrounds? You know, I worry about a one-size-fits-all
approach. Do we need to tailor best practices to different
populations?
Dr. Frank. Thanks for that question. Our approach is very
much aimed at two things. One is matching policies to context,
locally, but also matching patients to actual treatments, and
we want to do both. And so, for example, just a couple weeks
ago we had a 50-State convening where we brought all the States
together, all 50 States and the District of Columbia together,
to talk about how to share best practices.
And what we did is we had breakout sessions where we had
regional breakouts, so in fact people who bordered one another
could talk about sort of common approaches that met their
particular circumstances. Likewise, we try to have a full
armamentarium of treatments available so that we can match
patients and their circumstances in the best possible way, and
our mechanism for doing this is largely grant support through
the States.
Mr. Engel. Thank you. Thank you all. And, Mr. Riley, thank
you for all you do.
Mr. Pitts. The Chair thanks the gentleman. The gentleman
yields back. Without objection, the Chair recognizes Mr. Tonko,
a member of the full committee, who wishes to ask questions for
5 minutes.
Mr. Tonko. Thank you, Mr. Chair. As I mentioned in my
opening statement, access to effective addiction treatment is
the biggest obstacle we face today in preventing more deaths in
this epidemic. We know that nearly 80 percent of persons with
an opioid addiction do not receive treatment. While the reasons
for these gaps are multifaceted, it is clear that capacity in
our current treatment system play some role.
A study published recently in the American Journal for
Public Health estimated a gap between treatment need and
treatment capacity between 1.3 and 1.4 million individuals in
the year 2012. This is why I joined with my colleagues in
introducing the TREAT Act, which would raise the arbitrary cap
on buprenorphine prescribing for certain providers and allow
physician assistants and nurse practitioners the ability to be
waivered providers.
As such, I was very encouraged by Secretary Burwell's
announcement to start the rulemaking process to address opioid
addiction and specifically addressed treatment hurdles such as
the DATA 2000 caps. Dr. Frank, what is the expected time line
and process for this rulemaking change?
Dr. Frank. You are not going to like this answer, but we
are going to move as fast as we can. But I can guarantee you
that this is extraordinarily high on my office's agenda and the
Secretary's agenda, and literally, we are meeting every week to
kind of get this pushed through.
Mr. Tonko. Thank you. And, Director Botticelli, we have
heard a number of concerns expressed today over the diversion
of buprenorphine. Is that the most commonly diverted opioid?
Mr. Botticelli. I will defer to my DEA partners on this in
terms of diversion. I would suspect that probably
pharmaceutical opioids are far more diverted than----
Mr. Tonko. Pharmaceutical?
Mr. Botticelli [continuing]. Buprenorphine diversion.
Mr. Tonko. OK. And what actions does the administration
recommend to address that diversion?
Mr. Botticelli. Part of, I think, what we need to look at--
and I have to be careful not to get ahead of the HHS rulemaking
authority here--but I think that looking at how we can continue
to support access to buprenorphine and other medications but
also being mindful of ensuring quality treatment and minimizing
diversion become really important. And I think you have heard a
willingness on the part of the administration to work with
Congress on how do we strike that balance as we move forward,
thinking about how many people who can prescribe, what is the
quality care setting that we can do it. I have seen models
across this country where we have been able to expand the
number of people who get access to medications through a wide
variety of, I think, really innovative State practice. And I
think we can use some of that thinking and some of that
guidance to help with the process about how we go forward.
Mr. Tonko. Let me ask you, Director Botticelli, why do you
think we make it so much harder for individuals to get the
treatments that help them recover than the drugs that get
people addicted in the first place?
Mr. Botticelli. I think there is a wide variety of -- you
know, both as a person in recovery and as someone who has been
doing this for a long time, I think stigma plays a huge role.
And I think, quite honestly, that we had viewed people with
addictive disorders and their families as less deserving of
care, and I think for a long time public policy has reflected
that. And I think now with the opioid epidemic I think we are
finally understanding some of the long-standing issues that we
have had in this country as it relates to how we have treated
people with addictive disorders. I think that is why our jails
and prisons, quite honestly, unfortunately, our de facto
treatment programs, that we viewed people with addictive
behaviors as morally flawed or bad people. And I don't think we
have seen them as deserving as a response, as people with a
disease.
Mr. Tonko. Well, I think all of you gave powerful
testimony, and it reminds us that we need to see addiction as a
disease. And until we do, we won't get the results we require.
And finally, Director, does the administration support
mandatory prescriber education on pain management and substance
use, prior to an individual being able to prescribe controlled
substances?
Mr. Botticelli. We do and we look forward to working with
Congress in terms of how we might make that happen.
Mr. Tonko. And there are things that Congress can do to
help with that effort?
Mr. Botticelli. Absolutely.
Mr. Tonko. And you will direct us?
Mr. Botticelli. And we look forward to working with you on
that.
Mr. Tonko. Absolutely. I thank you all again for your
testimony. It, I think, was very instructive. And with that,
Mr. Chair, I will yield back the balance of my time.
Mr. Pitts. The Chair thanks the gentleman. That concludes
the questioning of members present. We have had members going
in and out all morning because we have another hearing on
Energy and Commerce being conducted downstairs, so I apologize
for that.
But I want to thank the first panel of witnesses. This is a
very important issue and we look forward to working with each
of you as we proceed on the legislation. And we will have some
follow-up questions, so we will send those to you in writing.
We ask that you please respond promptly. I remind members that
they have 10 business days to submit questions for the record.
Members should submit their questions by the close of business
on Thursday, October 22. I have a U.C. request, a statement for
the record, on behalf of the Opioid Treatment Program
Consortium. Without objection, so ordered.
Mr. Pitts. The subcommittee will stand in recess until the
week of October 20, when we will convene our second panel on
this issue.
The subcommittee stands in recess.
[Whereupon, at 12:02 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Fred Upton
Today we will discuss several important bipartisan
legislative proposals aimed at addressing the drug abuse crisis
that is sadly unfolding in communities in my home State of
Michigan as well as across the country. These bills and this
hearing build upon the solid foundation laid by the Oversight
and Investigations Subcommittee, which has held several
hearings and meetings and heard from two dozen witnesses,
including from the Federal Government, our partners in the
States, and a wide range of health professionals and addiction
specialists. They spoke about the root causes as well as the
consequences of our nation's complex and growing opioid
epidemic and about potential solutions.
In addition to the O&I hearings, many of my colleagues on
both sides of the aisle have participated in numerous
discussions back home with impacted constituents and local
leaders about the devastating effects this public health crisis
is having on our communities. In August I participated in an
event in St. Joe, Michigan, with various local leaders to
discuss the devastating effects of prescription drug and heroin
abuse that was gripping our community.
There were 13 suspected overdoses in Kalamazoo in the first
quarter of 2013, up from 9 in the first quarter of 2012.
Opiate-related overdoses have recently become the number one
cause of injury related death in Michigan and nationwide. This
sad reality has hit hard at home in Kalamazoo County. In 2008,
we lost Amy Bousfield, 18 years old and a graduate of Portage
Central High School. In 2012, Marissa King died at 21 years
old. She began using heroin in 2009, despite having lost two
friends to the drug, including Amy Bousfield. This crisis does
not discriminate between large and small, rural and urban, rich
and poor. Now it is time to take what we have learned and begin
making changes to help.
We have learned that while addiction is not easy to treat,
it is treatable, and we need to rise to this challenge for the
sake of the American family. Mr. Botticelli sitting before the
committee today is an example that this disease is beatable. He
is a champion of the patient community. We thank you for your
continued efforts.
I commend those of you who have worked diligently on the
legislation being discussed today and I look forward to
continuing to learn about and work on these various bills. As
we move forward, we must harmonize our efforts with the efforts
already underway at the Federal and State levels, in order to
take constructive and effective action, and I am committed to
doing just that.
Prepared statement of Hon. Joe Barton
Mr. Chairman, I am pleased that we will be marking up H.R.
8, the North American Energy Security and Infrastructure Act of
2015, H.R. 3242, the Child Nicotine Poisoning Prevention Act
and reconciliation recommendations today.
The reconciliation recommendations include three important
parts. Section one repeals the Prevention and Public Health
Fund, often referred to as the ``Obamacare slush fund'', which
will result in a savings of $12.7 billion over 10 years.
Section two prevents Federal Medicaid dollars from going to
private entities that perform abortions, such as Planned
Parenthood, for 1 year. Section three redirects these Medicaid
dollars to Community Health Centers. We all support funding for
quality and widely accessible women's health centers, and I
believe this reconciliation recommendation will ensure women
have access to care while protecting the unborn.
I am pro-life because I believe that all life is precious
and should be respected and I back that up with my vote. As a
lawmaker, I have a constitutional and moral obligation to
protect those who do not have the power to protect themselves.
I will continue to fight in Congress for the unborn.
In addition, I am glad that we are marking up HR 8 as well.
As the chairman of the Conference on the 2005 Energy Bill, I
appreciate all the hard work it has taken to get to this point.
While I may not agree with every provision, I know that getting
into conference is the only path to the President's desk. I
hope that all my colleagues on both sides of the aisle feel
that creating sound energy policy is in the best interest of
our country and will support this process moving forward.
Prepared statement of Hon. Frank Pallone, Jr.
Thank you, Mr. Chairman, for calling today's hearing. I
want to start by sharing a story from one of my constituents
from Old Bridge, New Jersey. She has already lost one son to
the drug abuse crisis and she is fighting to save her remaining
son's life as he suffers from his own opiate dependence. Her
younger son overdosed at the age of 21 and her older son--who
was struggling with addiction when his brother died--continues
that struggle.
No mother should have to endure this tragedy--having
grieved the loss of one son and being overwhelmed with worry
that she could lose another to the opiate epidemic. I know such
stories are not unique to New Jersey or my District.
Unfortunately, most of us have heard similar stories from
constituents, family members, or friends. Each day we are
losing 44 people in the U.S. from overdose of prescription
painkillers. We must take action to combat this epidemic.
That is why I am pleased that we are holding this hearing
on several bills to combat this drug abuse crisis. I strongly
support efforts to expand access to substance abuse treatment
services, increase access to overdose reversal medication,
improve provider education, and increase public awareness of
the problems of substance abuse.
That is why I support H.R. 2536, H.R. 2805, H.R. 3680, H.R.
3691, and I would like to thank Representatives Tonko, Kennedy,
Sarbanes, and Lujan for their leadership on this issue. I
briefly want to mention that I have concerns with the remaining
substance abuse treatment bill--H.R. 2872, the Opioid Addiction
Treatment Modernization Act. While I support the goal of
expanding access to all FDA-approved medications for the
treatment of opiate dependence and I support efforts to
increase provider education and training generally--I believe
we must pursue those goals in a way that does not undermine our
efforts to expand access to substance abuse treatment services.
I don't think H.R. 2872 strikes the right balance and, as a
result, could harm access to care.
There are also another two bills we will discuss today.
H.R. 3537, which would place a number of synthetic drug
substances on Schedule I of the Controlled Substances Act. Use
of synthetic drugs has led to numerous overdoses and deaths,
primarily among young adults. More must be done to eliminate
the availability of these substances, and enable DEA to take
appropriate enforcement action as H.R. 3537 strives to do. I am
concerned, however, about whether the broad list of chemicals
in the bill might include chemicals that can have legitimate
research uses for developing important medical therapies.
The other bill, H.R. 3014, would allow registered
physicians to transport controlled substances away from their
registered practice locations to other locations, such as team
physicians traveling to a game out of State, or physicians
responding to a disaster in a neighboring State. I hope to work
with stakeholders to ensure that the proper safeguards are in
place to address this problem and maintain access to drugs for
patients only when needed.
I look forward to hearing from all of our witnesses, and
continuing the conversation about how to address the issue of
substance abuse moving forward.
[H.R. 2536, H.R. 3014, and H.R. 3537 have been retained in
committee files and also are available at http://
docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=104047.]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
EXAMINING LEGISLATIVE PROPOSALS TO COMBAT OUR NATION'S DRUG ABUSE
CRISIS--DAY 2
----------
TUESDAY, OCTOBER 20, 2015
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 4:00 p.m., in
room 2322, Rayburn House Office Building, Hon. Joseph R. Pitts
(chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Guthrie, Shimkus,
Blackburn, Bucshon, Brooks, Sarbanes, and Pallone (ex officio).
Also present: Representative Tonko.
Staff present: Clay Alspach, Chief Counsel, Health; Sean
Bonyun, Communications Director; Leighton Brown, Press
Assistant; Katie Novaria, Professional Staff Member, Health;
Graham Pittman, Legislative Clerk; Chris Sarley, Policy
Coordinator, Environment and the Economy; Adrianna Simonelli,
Legislative Associate, Health; Sam Spector, Counsel, Oversight
and Investigations; Heidi Stirrup, Policy Coordinator, Health;
John Stone, Counsel, Health; Jeff Carroll, Democratic Staff
Director; Eric Flamm, Democratic FDA Detailee; Tiffany
Guarascio, Democratic Deputy Staff Director and Chief Health
Advisor; Samantha Satchell, Democratic Policy Analyst; and
Kimberlee Trzeciak, Democratic Healthy Policy Advisor.
Mr. Pitts. Ladies and gentlemen, if you can take your
seats, the subcommittee will come order.
We are reconvening this hearing. We had the first panel a
week ago, couple weeks ago, and this will be the second panel.
So welcome back.
For those of you just joining us today, today is the second
day of our hearing to examine legislative proposals to combat
our Nation's drug abuse crisis. On the first day of the
hearing, which took place on October 8, we heard testimony from
a panel of Federal witnesses representing DEA, HHS, and the
Executive Office of the President. Today, we will hear from a
number of distinguished doctors with a wide variety of
expertise.
On our panel today we have--and I will introduce them in
the order of their presenting their testimony--first, Dr. Paul
Halverson, Dean, Indiana University's Richard M. Fairbanks
School of Public Health.
Welcome.
Secondly, Dr. Chapman Sledge, Chief Medical Officer,
Cumberland Heights.
Welcome.
Third, Dr. Robert Corey Waller, Chair of the American
Society of Addiction Medicine's Legislative Advocacy Committee.
Welcome.
Then, Dr. Kenneth Katz, Department of Emergency Medicine,
Section of Medical Toxicology, Lehigh Valley Health Network.
Welcome.
And I don't see Dr. Allen Anderson yet, President of the
American Orthopaedic Society for Sports Medicine.
So thank you for coming. Your written testimony will be
made a part of the record. You will each have 5 minutes to
summarize your testimony, and after opening statements we will
do the questioning.
So, Dr. Halverson, you are recognized for 5 minutes for
your summary.
STATEMENTS OF PAUL K. HALVERSON, PH.D., DEAN, RICHARD M.
FAIRBANKS SCHOOL OF PUBLIC HEALTH, INDIANA UNIVERSITY; CHAPMAN
SLEDGE, M.D., CHIEF MEDICAL OFFICER, CUMBERLAND HEIGHTS
FOUNDATION; ROBERT COREY WALLER, M.D., CHAIR, LEGISLATIVE
ADVOCACY COMMITTEE, AMERICAN SOCIETY OF ADDICTION MEDICINE;
KENNETH D. KATZ, M.D., SECTION OF MEDICAL TOXICOLOGY,
DEPARTMENT OF EMERGENCY MEDICINE, LEHIGH VALLEY HEALTH NETWORK;
AND ALLEN F. ANDERSON, M.D., PRESIDENT, AMERICAN ORTHOPAEDIC
SOCIETY FOR SPORTS MEDICINE
STATEMENT OF PAUL K. HALVERSON
Dr. Halverson. Thank you, Mr. Chairman.
Chairman Pitts, Ranking Member Green, Representative
Brooks, thank you for the opportunity to testify today.
I come before you today as both the founding dean of the
Indiana University Richard M. Fairbanks School of Public Health
at IUPUI as well as the former State health officer of Arkansas
to discuss a very important and far-reaching public health
issue: the heroin and prescription drug abuse epidemics and the
deleterious effects which we are experiencing across the
country and in my home State of Indiana.
We know addiction is a tragedy not for the addicted person
alone but also for families, employers, and entire communities.
Addiction is often at the root of myriad social, physical,
mental, and public health problems. It harms all in its path,
even the most innocent among us.
Newborns who have been exposed to opioids in utero are
often born with a condition called neonatal abstinence
syndrome. In the last 15 years, the number of affected babies
is five times higher, mirroring the surge in opioid abuse over
the same time period.
The financial costs of drug addiction for health care,
criminal justice, and education are staggering. In my State of
Indiana alone, the costs are estimated at over $7.3 billion
annually. Hospital charges for babies born with NAS were over
$1.5 billion nationally in 2013.
Opioid abuse is particularly pernicious because it is often
a precursor to heroin use. SAMHSA found that nearly four out of
five new heroin users took nonmedical prescription pain
medication before taking up heroin.
The end result: People are dying. CDC notes that 44 people
die each day in our country from an overdose of pain
medication. Nationally, heroin-related deaths have escalated
over 39 percent between 2012 and 2013. And although mortality
rates are up in many States in the country, Indiana is one of
only four States where the rate of overdose deaths has
quadrupled in 14 years.
Indiana made the national news this past spring with its
public health crisis related to opioid abuse. Scott County, a
population of less than 25,000 people, had an unprecedented
outbreak of HIV related to needle sharing among intravenous
drug users injecting prescription opioids. To date, the number
of new confirmed cases of HIV for 2015 exceeds 180 people. This
numberis particularly alarming since the entire southeastern
region of Indiana has never had more than five new cases
annually prior to this year.
In addition, significant cuts in already chronically
underfunded public health infrastructure nationwide make
communities even more vulnerable and frequently leaves them
without important public health services, such as education on
how to protect themselves against life-threatening diseases and
access to confidential HIV testing and treatment, among other
important services like epidemiology and outbreak investigation
capacity. Indiana's public health system is particularly
vulnerable, with our overall health ranking at 41 and our
funding of public health services at 47 out of the 50 States.
Between 2009 and 2013, this small, rural county led the
entire State in both drug overdose deaths and nonfatal
emergency department visits due to opioid overdose. It is also
important to point out that there are numerous counties in
Indiana and, frankly, throughout the country that are
strikingly similar by virtue of their social and demographic
characteristics as well as the fragile public health system
capacity that exists.
We are grateful to colleagues from the CDC for assisting
our State health department, under the leadership of Dr. Jerome
Adams, as they responded to and supported local public health
and community leaders; and to Governor Pence for recently
establishing an executive branch task force to focus State
government agencies on the system issues surrounding substance
abuse.
In addition, our attorney general's longstanding
Prescription Drug Task Force has been focused on the
coordination and oversight of Indiana's prescription drug
monitoring program, and its insight has been instrumental in
developing legislative and policy-level recommendations.
Lastly, I would like to acknowledge the support that the
Richard M. Fairbanks School of Public of Health has provided,
primarily through the leadership of Dr. Joan Duwve, who has
tirelessly led and supported these efforts in our State.
In spite of these important State efforts, though,
additional national legislative efforts are needed. We are
grateful to Representative Brooks and other members of the
committee for shedding light on the very serious problems with
opioid abuse and heroin use, which are becoming more pervasive
with each passing day. It is clear we need to effectively
attack these problems from a system perspective to prevent
further destruction of our public's health.
I applaud your efforts, and I am grateful for your
dedication in addressing this important public health issue.
Thank you, sir.
[The prepared statement of Dr. Halverson follows:]
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Mr. Pitts. The Chair thanks the gentleman and now
recognizes Dr. Sledge for 5 minutes for your summary.
STATEMENT OF CHAPMAN SLEDGE
Dr. Sledge. Thank you, Mr. Chairman. I want to thank this
committee for holding this important hearing on legislative
solutions to combat the worsening drug crisis in our country.
Like all of us, I am deeply concerned as to what I see
happening in regards to the opioid epidemic in particular, and
I am grateful to have this opportunity to share my thoughts and
experience.
I am chief medical officer of Cumberland Heights, a
private, not-for-profit addiction treatment center on the banks
of the Cumberland River in Nashville, Tennessee. I previously
served as medical director of addiction treatment services at
Pine Grove Behavioral Health in Hattiesburg, Mississippi, and
have been practicing addiction medicine for over 26 years.
I am certified by the American Board of Addiction Medicine.
I am a fellow of American Society of Addiction Medicine, and,
from 2005 to 2009, I represented Mississippi, Alabama, Florida,
Tennessee, and Kentucky on the board of directors of ASAM and
served as secretary of the organization until 2011.
Cumberland Heights has a 50-year tradition of treating
addiction. We provide treatment to adult men and women as well
as adolescents. Most of our patients are working-class and
insurance-dependent, but we treat a fair number of patients
with resources to self-pay, and we treat a fair number of
patients dependent upon scholarships to provide their
treatment.
A watershed moment in my career as an addiction medicine
specialist came around 2006 on a Saturday morning. I was making
rounds on a detox unit with 25 beds, and I realized that every
single one of those patients had a diagnosis of opioid
dependence, and that was new to me. Some of those patients had
other diagnoses, as well, but every single one of them had a
diagnosis of opioid dependence. And, in fact, every single one
of those patients was dependent upon prescription opioids.
Our most common diagnosis at Cumberland Heights of the
1,500 admissions per year has been opioid dependence,
particularly in young adults. Tennessee leads the Nation in
prescriptions for opioids per capita. And heroin addiction has
become more and more prevalent as access to prescription
opioids becomes limited through less abusable formulations,
monitoring of controlled substance prescription databases, as
well as education.
The Tennesseean, Nashville's local newspaper, ran a cover
story on the opioid epidemic last month. To quote, ``At least
1,263 Tennesseeans died last year from opioid overdose, up 97
deaths from 2003--a staggering statistic that points to growing
abuse despite an array of measures to stem addiction. More
people died in 2014 from opioid overdose in Tennessee than by
car accidents or gunshots.''
My expertise is based in direct patient care; I am an
expert in what my patients disclose to me face-to-face in my
office. Almost all of our patients admitted to Cumberland
Heights for treatment of opioid dependence have some experience
with buprenorphine, either by prescription or by buying the
medication off the street. Over the years, I have been amazed
at stories of diversion and abuse of buprenorphine among
patients presenting to Cumberland Heights for treatment.
Buprenorphine is sometimes used under the tongue, as it is
designed. It can be used intranasally or even injected.
Motivations for illicit use of buprenorphine include to get
high as well as to treat withdrawal. Of course, some patients
with buprenorphine diversion and abuse take it with the
motivation to stop using other opioids.
A typical 8-milligram dose of buprenorphine costs $20 in
middle Tennessee when obtained illicitly and, in east
Tennessee, as much as $40 per 8-milligram dose. The street
value supports my observation as to the level of diversion and
abuse of buprenorphine. In fact, buprenorphine has been
identified as the third-most-diverted medication in the U.S. by
the DEA.
At a 2008 meeting of the American Society of Addiction
Medicine's Medical Scientific Conference in Miami, I was asked
by a colleague if I use buprenorphine to treat opioid
dependence. I replied that we utilize buprenorphine to detox
from opioids. He remarked that he had never seen a patient
recover without buprenorphine, and I told him that I had
recovered from opioid dependence without buprenorphine. He
said, ``Yes, but you weren't using intravenously.'' He appeared
incredulous when I told him that I had recovered from IV opioid
addiction without buprenorphine or methadone.
I cringe when an addiction medicine treatment provider
makes a recommendation based on his or her personal experience
in treatment and recovery; that is not what I am saying. But my
experience indicates that there are multiple paths to recovery.
There is no one-size-fits-all.
At Cumberland Heights, we promote abstinence after detox,
we provide psychosocial treatment, and we use a long-acting
opioid blocker, Vivitrol, as well as incorporation of a
spiritual basis of recovery through 12-step facilitation. We
completely understand that addiction is a chronic illness, and
ongoing recovery requires ongoing treatment. No one is claiming
that detox from opioids alone will result in recovery.
And I thank you for the opportunity to speak.
[The prepared statement of Dr. Sledge follows:]
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Mr. Pitts. The Chair thanks the gentleman and now
recognizes Dr. Waller, 5 minutes for your opening statement.
STATEMENT OF ROBERT COREY WALLER
Dr. Waller. Thank you, Chairman Pitts and Ranking Member
Green. Thank you very much for inviting me to participate in
this important hearing. I am grateful to you and the other
members of the subcommittee for your leadership in addressing
the epidemic of opioid addiction currently ravaging our
country.
My name is Dr. Corey Waller, and I am the chair of the
Legislative Action Committee of the American Society of
Addiction Medicine, also known as ASAM. This testimony is
offered on behalf of ASAM, myself as a practicing addiction
specialist physician, and my patients who are unable to speak
before this committee themselves.
I am board-certified in both addiction medicine and
emergency medicine. I am the medical staff chief of pain
medicine to the Spectrum Health Hospital System as well as the
substance use disorder medical director at a regional community
mental health organization based in Grand Rapids, Michigan.
My testimony today will focus on the following three facts:
Addiction is a chronic disease of the brain that leads to
characteristic biological, psychological, and social
manifestations; addiction involving opioid use can be
successfully treated with a combination of medications and
psychosocial interventions; and we have published guidelines
that detail best practices for the use of these medications.
There are significant barriers to access to these effective
medications, resulting in a significant addiction treatment gap
in our country. This is, without question, a chronic
neurobiological disorder that starts with a genetic risk, is
informed by the environment, and is solidified by the culture
surrounding it. Not unlike diabetes or hypertension, we can
effectively manage the disease, but stopping that treatment
prematurely costs us lives.
We are here today to provide recommendations on how best to
respond to the epidemic of prescription opioid and heroin
misuse, addiction, and related overdose deaths. According to
the Centers for Disease Control, we have reached epidemic
levels in our country. We have all seen the data and heard the
shocking statistics, but what is not said or heard enough is
that the 2.3 million people who need treatment for opioid
addiction have a chronic disease of the brain. While we need to
prevent other Americans from developing addiction, these 2.3
million people need treatment now.
There are currently three medications that are FDA-approved
to treat opioid addiction: methadone, which has been used in
highly regulated opioid treatment programs since the 1960s;
buprenorphine, which has been used since 2002 by physicians who
complete a special training in their offices; and naltrexone,
which is not a controlled substance and can be administered by
any licensed prescriber.
All of these medications have proven to be clinically
effective. A 2013 review of the scientific literature found
substantial, broad, and conclusive evidence for the
effectiveness of all three medications and for methadone in
particular. Notably, the literature on efficacy of these
medications is not new. There are now eight large-scale,
rigorously conducted reviews of the literature on these
medications since the early 1980s. All FDA medications have
been shown to reduce mortality.
Finally, we have a clear and comprehensive guideline for
how to use these medications effectively in the clinical care
of persons with addiction. However, despite the strong,
evidence-based use of these medications and the clinical
guidance available, very few eligible patients are offered
medication to help treat their disease. Less than 30 percent of
treatment programs offer medications, and less than half of
eligible patients in those programs receive medications.
Indeed, a study published just last week in the Journal of the
American Medical Association found that 80 percent of Americans
with opioid addiction don't receive treatment.
This treatment gap is attributable to many factors, some
more complex than others. Research has demonstrated significant
access barriers to methadone, including waiting lists for
treatment entry, limited geographic coverage, limited insurance
coverage, and the requirement that many patients receive
methadone at an OTP daily.
DATA 2000 was intended to expand access to addiction
treatment across geographies and populations by integrating it
into the general medical setting. In recent months, my practice
has had to turn away patients due to the 100-patient limit for
buprenorphine, and this includes pregnant patients as well as
the children of my friends, and has resulted in at least 2
overdose deaths that we can track.
If I am out of town or unavailable, my physician assistants
are unable to see patients who need an urgent intake due to the
restrictions on PAs and nurse practitioners writing for
buprenorphine, which exists even if they are under the guidance
of a physician who is board-certified in addiction.
It is important to note that the entire purpose of DATA
2000 was to make opioid treatment available outside an OTP, in
traditional physician's offices, both to increase access in
areas where OTPs may be physically inaccessible and to reduce
the stigma and patient burden associated with visiting an OTP
for treatment on a daily basis.
Still, because diversion and quality of care remain
legitimate concerns, ASAM has proposed a gradual and limited
lifting of the DATA 2000 limits. By coupling a lifting of the
patient limit with increased training requirements and
accountability for those physicians treating large numbers of
patients, we feel we can expand access while also ensuring a
certain quality of care.
Still, this single strategy should be just one part of a
broader Federal effort to ensure safe prescribing of opioids
for pain, alternative pain therapy options, and early
identification and treatment of addiction.
Pain and addiction education should be required curriculum
in medical school and encouraged as continuing medical
education throughout a physician's career. Communities should
have the resources to educate their citizens about these issues
and the outreach and surveillance resourcesnecessary to better
understand the unique issues and needs.
Thank you again for the opportunity to present here today.
ASAM and myself look forward to a continued collaboration on
this and other addiction-related issues.
[The prepared statement of Dr. Waller follows:]
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Mr. Pitts. The Chair thanks the gentleman and now
recognizes Dr. Katz, 5 minutes for your summary.
STATEMENT OF KENNETH D. KATZ
Dr. Katz. The drug epidemic confronting this Nation has
exploded in recent years due to the accessibility of cheaply
made, mass-produced deadly synthetic drugs. As a physician on
the front line, I have witnessed how these dangerous compounds
have directly led to violence, hospitalizations, and deaths.
For example, in both the adult and pediatric intensive care
units in Allentown, Pennsylvania, this spring, I spent
countless hours at the bedside caring for many patients
suffering from the toxic effects of synthetic marijuana which
ripped through eastern Pennsylvania, leaving in its wake
multiple patients in emergency departments, hospitals, and,
unfortunately, morgues.
Mr. Chairman and members of the subcommittee, my name is
Dr. Kenneth Katz, and I am board-certified in emergency
medicine, medical toxicology, and internal medicine. Thank you
for allowing me to testify today on behalf of the American
College of Emergency Physicians to discuss the dangers posed by
synthetic drugs and to advocate for enactment of H.R. 3537, the
Synthetic Drug Control Act of 2015.
In every community across the Nation, my colleagues and I
are treating more and more patients who have experienced
synthetic drug toxicity or poisoning. It is important to
understand that the term ``synthetic drugs'' we are using here
today describes substances that are primarily manufactured in
clandestine Chinese laboratories and actually represents a
nimiety of chemical combinations that are designed to mimic the
effects of illegal chemicals with stimulant, depressant, or
hallucinogenic properties. They are nonorganic, chemically
synthesized, unsafe recreational drugs that produce
psychoactive or mind-altering effects.
Many of these substances are marketed as innocuous
products, such as incense, plant fertilizer, or air freshener
and then sold in convenience stores, gas stations, or online.
Because of their commercial availability, many users presume
they must be safe. However, the public should not be fooled.
Even though these products may be hiding in plain sight, they
are colorfully packaged poison.
Unlike most illicit drugs, synthetics can contain a vast
array of different chemicals with varying potencies. For
example, synthetic marijuana may contain compounds 2 to 500
times more powerful than THC. In many cases, the manufacturer's
only goal is to alter the chemical compound in such a way as to
technically create a new compound, allowing them to circumvent
legislative and regulatory bans.
This modification process poses increasing risk to users,
who are unaware of the reactions the new chemicals or
formulation may cause. It is not until these substances are
ingested or inhaled that some or all of the following symptoms
can occur: hyperthermia; elevated blood pressure and pulse;
severe, uncontrollable agitation; seizures; coma; muscle
breakdown; kidney injury; and, ultimately, death.
Unfortunately, at that point, it may be too late for either my
emergency medicine colleagues or even me, as a medical
toxicologist, to save them.
While there is an increasingly expanding array of synthetic
drugs being manufactured, of particular concern to ACEP is the
availability and high use of synthetic marijuana. Whether it is
the data from SAMHSA's Drug Abuse Warning Network, DEA's
National Forensic Laboratory Information System, or Poison
Control Centers, it is clear: Synthetic marijuana use has
increased exponentially since it first appeared in the United
States a few years ago.
For example, according to NFLIS, there were 21 reported by
2009. By 2012, that number grew to more than 29,000, an
increase of more than 1,400 percent. Through the first 6 months
of 2014, there were already close to 20,000 synthetic marijuana
drug reports. My home State of Pennsylvania has been especially
hit hard by the increasing use of synthetic marijuana, trailing
only New York, Mississippi, and Texas in the number of reported
exposures this year.
Currently, all 50 States have banned some cannabinoids and
cathinones, with the majority doing so through legislation.
Since synthetic compounds are easily manipulated to make new
drugs, many States have passed laws targeting entire classes,
substances, or used broad language to describe the prohibited
drugs.
Federal statues must also be updated to meet this
constantly evolving challenge and restrain these dangerous
products. The Synthetic Drug Control Act of 2015, sponsored by
Representatives Charlie Dent and Jim Himes, would amend the
Analogue Act so that a substance can be treated as an analogue
if it is chemically similar or produces a similar clinical
effect. In addition, the bill would add more than 200 known
synthetic drugs to Schedule I of the CSA.
This legislation is targeted to the manufacturers and
distributors of synthetic drugs, not the end users. H.R. 3537
would amend the Analogue Act so that it would only apply to the
sale, manufacture, import, and distribution of drugs, not
simple possession.
The easy access to and thoughtless use of synthetic drugs
by those who are unaware of their dangerous toxicities not only
places their health and lives at risk but can have a profound
impact upon my ability to care for all my patients. When users
of synthetic drugs need emergency medical attention, they are
utilizing precious resources such as ambulances, emergency
department beds, hospital personnel, and limited healthcare
dollars.
It is both my opinion and that of the American College of
Emergency Physicians that this critical issue must be addressed
through the enactment of H.R. 3537 and supplemented by a
national campaign to educate Americans about the dangers of
using synthetic drugs.
Thank you.
[The prepared statement of Dr. Katz follows:]
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Mr. Pitts. The Chair thanks the gentleman and now
recognizes Dr. Anderson, 5 minutes for your summary.
STATEMENT OF ALLEN F. ANDERSON
Dr. Anderson. Good afternoon. I am Dr. Allen Anderson, an
orthopedic surgeon specializing in sports medicine, and I am
also the president of the American Orthopedic Society for
Sports Medicine, or AOSSM. It is a nonprofit organization made
up of 3,400 orthopedic surgeons specializing in the care of
athletic injuries at every level of competition.
Eighty percent of AOSSM members are team physicians, and 60
percent of our members take care of high-contact collision
sports, where serious injury can occur. A team physician has
unique responsibilities and qualifications. He or she must have
fundamental knowledge of on-field emergency care and treatment
of musculoskeletal injuries and medical conditions.
Today, I will discuss the need for a team physician to be
able to carry controlled substances when traveling with the
team and the problems with current law; the fact that
workarounds are not practical; and why H.R. 3014, the Medical
Controlled Substances Transportation Act, will enable team
physicians to provide the best quality medical care to our
injured athletes.
In emergencies or disasters where there is significant
trauma, it is critical that a physician have immediate access
to controlled substances. There are times, such as during air
travel or on a bus, when the team physician is the only medical
person available. There are documented cases of players having
seizures after concussions on a flight home, and, in such
situations, controlled substances are needed to stop the
seizure and perhaps save the athlete's life. Additionally, it
is humane care to allow a player to take a pain pill if he or
she has a broken bone, dislocated shoulder, or torn ACL.
As you watch your favorite team on Saturdays, one or more
athletes is significantly injured in almost every game. These
players are your constituents from every State. The team
physician, who is probably a member of AOSSM, is there on the
sideline to render aid and take responsibility for the
athlete's wellbeing. This aid is being severely restricted by
current law.
The current law prohibits the transportation and storage of
controlled substances away from the site of storage that is
registered with the DEA. This makes it illegal for team doctors
to transport a limited quantity of critical medications that
are needed for pain control or emergency management. This is
highly problematic for athletic team physicians, who need the
ability to maintain a limited supply of controlled substances
if a player is injured at an away game. The current law also
precludes controlled substances from being transported within
the same State or across State lines.
The current workarounds are problematic. Current options
include predispensing medications to every member of the team
prior to travel. That would be 80 members on a football team.
This would create a logistical nightmare.
Delegating the dispensing of controlled substances to the
home medical staff in the State of entry. This is also a
problem. The opposing team physicians can provide medications,
but they have to independently examine the patient, and they
have limited time due to demands to treat their own team. This
would be create malpractice concerns for that physician of
prescribing medications and not following that patient.
There are also privacy concerns. The local physician is
generally caring for the competing team. This would be
unacceptable for the coaching staff to enter the training room.
H.R. 3014 would address these concerns. It allows the
physician who is traveling with a team the ability to
appropriately manage the injury in a similar fashion to when
they are in their home facilities. It does not diminish the
need or requirement for controlled substances to be monitored
at the current level.
Records of controlled substances dispensed are maintained
and subject to inspection by the DEA at any time. The team
physician will be responsible for the security of the
controlled substances throughout the entire time the team will
be traveling, and the duration of transport is limited to 72
hours.
Military flight surgeons and rural large-animal
veterinarians have an exemption to carry these medications.
Contact sports can be much more perilous than noncombat
military maneuvers. It is also hard for me to believe that
horses and, potentially, cows could get better medical
treatment than our athletes.
This legislation would also benefit patients and physicians
who donate their time in declared disaster areas in their
States or other States.
Therefore, we urge you to support H.R. 3014, the Medical
Controlled Substances Transportation Act, so that we can
provide the highest level of care for our injured athletes.
Thank you for giving me this opportunity to testify, and I
am happy to take questions.
[The prepared statement of Dr. Anderson follows:]
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Mr. Pitts. The Chair thanks the gentleman.
That concludes the opening statements of our second panel.
I have a UC request. I would like to submit the following
documents for the record: statements from the College on
Problems of Drug Dependence; the National Association of
Convenience Stores; Dr. Cooper, head team physician of the
Dallas Cowboys; the Fraternal Order of Police; the Society of
Former Special Agents of the FBI; the American Medical
Association; the American College of Emergency Physicians; the
American Association of Orthopaedic Surgeons; the Center for
Lawful Access and Abuse Deterrence; the American Academy of
Physician Assistants; and the National Association of Chain
Drug Stores.
Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
[The information appears at the conclusion of the hearing.]
Mr. Pitts. I will begin the questioning and recognize
myself 5 minutes for that purpose.
Dr. Halverson--and, Drs. Sledge and Waller, you can respond
here, too--do you all agree that patients addicted to opioids
should receive treatment based on their individual clinical
needs?
Dr. Halverson?
Dr. Halverson. Yes, sir.
Mr. Pitts. Dr. Sledge?
Dr. Sledge. Absolutely.
Mr. Pitts. Dr. Waller?
Dr. Waller. Yes.
Mr. Pitts. How would you each advise HHS to take this
principle into account when considering how to responsibly
implement Secretary Burwell's recent announcement to expand the
use of medication-assisted therapy?
Dr. Halverson?
Dr. Halverson. Since I am not a physician, I would like to
defer to my colleagues here.
Mr. Pitts. OK. All right.
Dr. Sledge?
Dr. Sledge. And I think that prescribing physicians should
be trained in all modalities of medication-assisted therapy as
well as other options, particularly psychosocial treatment,
with abstinence as an option.
Mr. Pitts. Dr. Waller?
Dr. Waller. So we have looked at this very closely in the
area that I treat. I am in charge of a seven-county area with
patients and figuring out how to treat that seven-county area.
We have been able to delineate two separate groups of patients
which we have good data for: those that started very early in
life and started earlier, in their adolescence, which have a
different brain disease than started later in life. Those
groups of patients actually separate us out a little bit, as
far as how treatment works.
So I have many patients in my clinic that are physicians,
pilots, and lawyers who I don't give any medication to because
generally it is not indicated. And we have wonderful outcomes
without any medication-assisted treatment for those groups
because of many other factors.
My groups, which are 92 percent of my patients, which are
Medicaid patients or those without insurance, I find that it is
a perilous journey to try to treat them without buprenorphine.
And the data backs that up, with a high mortality rate
associated with this group of patients specifically.
And so Dr. Sledge and I are saying the same thing. It is
absolutely the right treatment for the right patient at the
right time, and making sure that we allow for an expansion of
use of these medications that save lives in the hands of those
people who are trained best to use them.
Mr. Pitts. All right.
You have touched on this, but expand a little bit more on
how should differences in certain types of patients and
treatment settings and therapeutic options be addressed.
Dr. Waller. Well, currently, we have guidelines that
directly do address the utilization of the medications. These
are the first guidelines that look at all three of the FDA-
approved medications, and it does speak to the behavioral and
psychosocial therapies without medications within there.
Generally, the medication treatment has been done in a
cohort of patients that do not represent a physician or pilot
or a lawyer, which, in general, we have programs within States
that surround them that are different than the general
programatic treatment pathways.
And so utilizing the guidelines that we have delineated
with the appropriate education to back that up would be the way
that I would say.
Mr. Pitts. Dr. Sledge?
Dr. Sledge. An overarching principle identified by the
Institute of Medicine for successful treatment included patient
self-determination. And I think that H.R. 2872, the Opioid
Addiction Treatment Modernization Act, brings patient self-
determination back to the equation.
Mr. Pitts. And, in your opinion, what are the most
significant obstacles at the present time preventing more
individuals with opioid use disorders from receiving the most
effective treatments?
Dr. Sledge. I think that one-size-fits-all treatment is
very detrimental to addressing the opioid epidemic. I think
that an assessment of each individual patient, with
recommendation and referral based on their individual needs, is
essential for successful treatment.
Mr. Pitts. Any other significant obstacles, Dr. Waller?
Dr. Waller. I think the legal obstacles to be able to
obtain the appropriate medications for patients if we deem it
is the right medication for them, such as specifically
buprenorphine for my patients.
I treat all of the pregnant patients in that seven-county
area, and I am out of space. And so I have to turn people away
to areas that are either less than optimal for them or, you
know, try our best with what we can do, but, unfortunately,
that doesn't turn out very well.
Mr. Pitts. Can each of you comment on the role nurse
practitioners and physician assistants play in providing
office-based opioid treatment?
Dr. Sledge. I am not a provider of office-based opioid
treatment, so I will defer to Dr. Waller.
Mr. Pitts. Dr. Waller?
Dr. Waller. Without the utilization of my physician
assistants, my office doesn't run. We have the capability to
see patients in volume because we have well-trained physician
assistants and nurse practitioners that work directly with
board-certified people in their other specialties, whether this
is a neurosurgeon or an orthopedic surgeon or an addiction
specialist. And, in this case, an addiction specialty--you
know, coupling my physician assistants along with behavioral
therapists with my patients works out really well, and we have
great outcomes from this.
And this is a model that has been adopted in the medical
home model of care and is relatively standardized throughout
medicine. And so to eliminate this as a possibility for this
specific disease doesn't make sense from a monetary standpoint
nor a patient delivery standpoint.
Mr. Pitts. Thank you.
I am out of time, but, Dr. Katz, you talked about synthetic
drugs. And with the movement towards legalization of medical
marijuana, is synthetic marijuana considered medical marijuana,
or are the advocates trying to include that in medical
marijuana?
Dr. Katz. Not that I am aware of. No, I think we are
talking about two different things.
Mr. Pitts. Yes. It is completely synthetic.
Dr. Katz. Yes.
Mr. Pitts. Yes. That is what I thought.
Thank you.
And, at this time, the Chair recognizes the gentleman from
Maryland, Mr. Sarbanes, filling in for Ranking Member Green.
Mr. Sarbanes. Thank you, Mr. Chairman.
Before I ask my question, I would ask unanimous consent to
enter a letter from the Purdue University College of Pharmacy,
Dr. Nichols, which provides some additional perspective on this
issue of adding certain synthetic drugs to the Schedule I CSA
and the implications of that for scientific research.
Mr. Pitts. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Sarbanes. Thank you.
I appreciate the testimony, everybody.
The first question I wanted to ask was--and maybe, Dr.
Halverson, from your, sort of, public health perspective, and
Dr. Waller, but others, as well--the word ``epidemic'' is
getting used a lot to describe this. And I, frankly, myself,
didn't appreciate that by the CDC definition of ``epidemic'' we
have actually gotten to that point.
Can you comment on--because, you know, ``epidemic,'' that
is kind of used in the vernacular to just describe something
that is sort of out of hand and serious. But, you know, if you
are talking about ``epidemic'' where it could be, you know,
analogous to a SARS epidemic or a MERS epidemic or an Ebola
epidemic, whatever, that is of a difficult scale and degree.
And if you could speak to that, any of you.
Yes?
Dr. Halverson. ``Epidemic'' is used in large part because
of the fact that we don't see an easily controllable end, that
we experience the phenomenon, whatever it might be, an epidemic
of flu or an epidemic related to any disease where the disease
is raging beyond our ability to control it, and the disease has
the potential to have profound impact.
And so, under those definitions, we certainly have seen an
epidemic of opioid abuse, of deaths. And the reality is that we
do have an idea of how to address the epidemic, but, at our
current point in time, we haven't reached the point where we
can actually say it is controlled.
Mr. Sarbanes. Any other perspectives on that?
Dr. Waller. So the two components of an epidemic is
susceptibility to something and then to be able to come into
contact with that something and have it spread.
We have seen exactly that pattern with heroin. If it shows
up in a community, those people who have susceptibility from a
genetic predisposition and then have already been started on
opioids or, in the case, unfortunately, of many areas, young
people who this is the first drug they touch, in some cases in
early high school, and then they have access and a genetic
risk, it grows just like the disease that we look at on
outbreak, where it just covers the map.
And that is what we are seeing. It kills more people in my
State than anything else. And it is all people that are young
and healthy as compared to other diseases that affect a whole
different population of people.
Mr. Sarbanes. So let's say tomorrow you were appointed the
opioid addiction czar, in the same way that we had an Ebola
czar----
Dr. Waller. I accept.
Mr. Sarbanes. OK--and you could take whatever steps you
thought were necessary, describe what the first two or three
things would be, both ones that would require additional
resources, would be resource-dependent, as well as, it seems,
ones that maybe are not resource-dependent, like lifting some
of the caps on the number of patients that can be treated and
so forth. What would your steps be?
Dr. Waller. Well, I think the first step would be a re-
education of the population about what the disease of addiction
is, that this is a chronic neurobiological disorder that has
more data about the brain-disease aspect than any other mental
health disease in the history that we have ever looked at----
Mr. Sarbanes. So is that PSAs? I mean, what is that? How do
you get that word out?
Dr. Waller. This is a Surgeon General's report, this is
public messaging, this is rebranding of a disease that has been
maligned in the face--and we have been treating this with an
emotional context, rather than a science context, for years. So
that has to be the first place.
Mr. Sarbanes. OK.
Dr. Waller. The second piece is access to all treatments.
And the third place is to build a structure around those
treatments so that they are delivered with high fidelity and
low risk.
Mr. Sarbanes. OK. Thank you.
I am interested because I have a piece of legislation on
this topic of this idea of encouraging coprescribing of
Naloxone at the time that a physician is prescribing a certain
kind of opioid.
And, you know, there would be some demonstration projects
around this to test the potential of this and to look at the
particular circumstances under which that would be
appropriate--the kind of patient, you know, their particular
vulnerabilities, and the likelihood of a potential overdose, et
cetera.
Can you just speak to your perspective on whether that
would be a useful step?
Dr. Waller. Well, first, Congressman Sarbanes, I appreciate
that piece of legislation. It is very impactful.
I carry Naloxone in my backpack. It is sitting behind me in
a ready, injectable pen, because it is something that we can
do--it is an anti-death serum. And so, to have this available
in a coprescribing way to family members and to patients alike
and to make sure that they are trained in the utilization of
this is no different than having an automatic defibrillator on
a wall in a gym. I mean, this is something that should be
publicly available, and this is a great step toward that. We
definitely support that. I personally support this, as well as
with ASAM as well.
I think the biggest issue with this--we need to make sure
and dispel the myth that somehow adding an antidote changes
patients' behavior to use more and more often. That has been
found through research to not be true. In the areas with which
we have allowed this to be legalized and given to police
officers and community members and made it available to
patients, we have seen nothing but a decrease in mortality. We
have not seen an increase in utilization. We have not seen an
increase in amount of utilization per person per time they use.
That is just not true.
And when you reverse somebody, that is one more time that
they are not dead, and, two, we have an opportunity to get them
into treatment.
Mr. Sarbanes. So you have to bring all the other measures
to bear and view that as kind of a first step back to that
opportunity.
Dr. Waller. Absolutely.
Mr. Sarbanes. Yes.
Thank you very much. I yield back.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the vice chair of the subcommittee, Mr. Guthrie, 5
minutes for questions.
Mr. Guthrie. Thank you very much.
And, first, as a comment to Dr. Anderson, I know you got up
here early. I saw you on the airplane, I believe, coming out of
Nashville this morning.
And I appreciate--and I am also working with your--not your
organization, but people that practice in your area, not just
for opioids that they are talking about being able to carry,
but, also, a friend of mine is an emergency room physician in
Auburn, Alabama, and so he traveled to Kentucky last Thursday
night with the Auburn Tigers to watch over the team while they
were playing our beloved Wildcats. And there is a licensing
issue, too, back and forth about a physician licensed in
Alabama to come travel with the team into Kentucky. We need to
fix that, as well, and that is something that we are looking
forward to doing.
Second thing, a lot of my good friends back in the
legislature in Kentucky, former colleagues of mine, were very
aggressive on OxyContin and prescription drugs and put forth
ways to manage prescription drug abuse and seemed to be very
successful with it. And I know some of the physicians were
really having to manage it very closely. And we thought, wow,
we really are getting a big handle on the supply of the
problem--which, supply is still a problem. You have to attack
supply all the way. And, all of a sudden, heroin became a big
component in Kentucky.
And somebody told me--I had lunch yesterday with one of our
drug task force leaders, and he said it is easier to get heroin
now than prescription drugs in Kentucky--I mean, illegal
prescription drugs, use of prescription drugs. And so we have
to attack the demand for it, as well, in what you guys do.
And so one of the questions I have for those of you who
practice in this area--I know, Dr. Halverson, I have a question
for you, too, but I don't think you are--you said you are not
an M.D. But anyone who would like to answer.
I know there are caps on what practices can use for
buprenorphine. And the question is, do you think the current
caps should be lifted? And if not, why? And if so, how?
So, any of you who practice in this area, I would love for
you to answer that question.
Dr. Waller. So I can address it initially.
The short answer is: Yes, but safely.
We have identified that this medication is diverted and, in
some cases, abused. I have patients that I treat for
buprenorphine abuse. They show up, and I treat them for that.
And now that we have the abuse-deterrent versions, the
inadvertent utilization of it through snorting or injection has
significantly declined, to the point where we generally don't
use the mono drug, the buprenorphine by itself, at all in my
clinic.
Mr. Guthrie. Do the caps put limits on you that you look at
it and say, wow, I could treat more people if I didn't have
this cap?
Dr. Waller. I have a 7-month waiting list, and it is purely
waiting on slots.
Mr. Guthrie. Because of the cap.
Dr. Waller. Because of the cap. And I have no one else in
my community of 1.3 million people that has any space on their
cap that is a specialist in this area.
Mr. Guthrie. Do the other--both of you practice in this
area, I believe, as well.
Dr. Sledge, do you have the same issues with the caps?
Dr. Sledge. Well, again, I don't practice office-based----
Mr. Guthrie. OK.
Dr. Sledge [continuing]. Opioid treatment. And there
certainly is not a cap involved with extended-release
naltrexone and its incorporation as a medication-assisted
therapy.
And, again, with the issue of diversion and abuse, I do
think that there needs to be diversion protection in whatever
measures are taken to increase----
Mr. Guthrie. Let me ask you a question, Dr. Sledge. So, in
your comments earlier, you talked about psychosocial should be
added to the--that you can't just treat through, like,
buprenorphine and those kinds of things. Why is that important?
Dr. Sledge. Why is that important?
Mr. Guthrie. Uh-huh.
Dr. Sledge. You know----
Mr. Guthrie. I want you to state the obvious. I want you to
say it for the record, why that is important.
Dr. Sledge. OK. Absolutely.
And I think just prescribing the medication is not going to
effect much of a change in the course of this chronic disease.
It is a chronic brain disease that affects not only with
biological manifestations but physiatric, physiological,
spiritual, and social manifestations. And all of those areas
have to be addressed for ongoing recovery.
I think that medication is uni-dimensional. When it is used
alone, it addresses the biological manifestations of the
disease. But the disease is multifaceted, and all of those
areas must be addressed for recovery.
Mr. Guthrie. I have one more question. If anybody wants to
add to that?
If not, thanks for doing that.
And, also, I guess this is really for the record, too, Dr.
Halverson, because I think a lot of us understand this. But
aside from the chronic health impacts of addiction and death
from overdose, what other public health or social impacts are
associated, in Indiana and nationally--in your role, I know you
see this nationally--with opioid use disorders?
Dr. Halverson. Right.
So one of the things that we experienced in Indiana with
the overdose patients were related to infections that occurred
as a result of intervenous drug use.
So, again, part of the issue is people overdose on drugs
for a number of different reasons. They frequently will also be
affected by infections as well as actual other diseases that
weren't intended as part of the effect that they were trying to
get from the medication.
But, additionally, there are a number of other issues that
are related to the community's overall health. And the ability
for the community to be resilient around this kind of disease
is important to take into consideration.
In part, there is, I think, a general lack of understanding
around drug abuse in particular. I think one of the questions
that was asked earlier was related to what would you do to
address the community awareness, and part of that is helping
people to understand the scientific basis of this disease. It
is, indeed, a chronic disease, and we need to begin to treat it
in that manner and approach it from a scientific perspective.
There still are number of people, unfortunately, that believe
that people ought to just quit that, they just ought to stop
this. And they don't recognize the fact that this is a disease
that needs to be treated.
We have to also make sure that people have access to
treatment, which is--in our State as well as others, there are
some problems getting access----
Mr. Guthrie. Thank you. I am kind of over my time, but I
appreciate you answering. I know I am over my time, and the
chairman needs to move on, but I appreciate your answer.
Thank you. I yield back.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the ranking member of full committee, Mr. Pallone, 5
minutes for questions.
Mr. Pallone. Thank you, Mr. Chairman.
My questions are of Dr. Waller.
As you know, or you mentioned, there are three FDA-approved
medications for the treatment of opioid dependence. There is
methadone, buprenorphine I guess you have been talking about,
and naltrexone. And I am interested in hearing more about
methadone.
Could you briefly describe how methadone is used to treat
individuals with opiate dependence? And are there special
requirements to treat individuals with methadone in a substance
abuse context?
Dr. Waller. Yes, sir. So methadone is a full agonist
medication, which means it resembles medications like oxycodone
and hydrocodone, morphine, in that way.
So for patients who have traditionally a heroin addiction
and specifically injecting heroin, we have great data that
states that utilizing this medication in a fully inclusive
biopsychosocial environment, not just the medication itself but
then specifically adding all of these, the biopsychosocial
aspects with that, significantly decreases craving for a drug
and, by doing that, allows them to continue to show up and have
a very high retention and treatment rate.
So about 75 percent of patients will be retained in
treatment on methadone as compared to buprenorphine, where you
will retain at about 65 percent. And then for new onset with
naltrexone, it is lower than that. That number hasn't been
fully vetted. But when we look at the----
Mr. Pallone. I guess what I am trying to be find out is why
buprenorphine should not be regulated like methadone. That is
what I am trying to get you to respond to.
Dr. Waller. So the basics are that the regulations around
methadone are significant. And for a primary care physician to
onboard the regulations, it would be a minimum of about
$150,000 immediately, with the paperwork, the accreditation
through the joint commission, the accreditation through CARF.
And then, at that point, you have to actually--there are
specific issues with almost all States where you would have to
then par with a community mental health, which requires a
request for proposals, which requires a hearing. It almost
completely negates the capability for a primary care doctor to
deliver this medication at all.
Mr. Pallone. But, again--I think you were getting at it,
but I still don't understand. What are the medical reasons to
justify why methadone comes with different requirements than
the other two drugs?
Dr. Waller. Well, one, those are historic, because that is
how it was started, and it has been very regulated since it was
initially utilized in this manner since the 1960s. Two, it does
have a higher potential for abuse than buprenorphine. Three, it
has a higher overdose risk than buprenorphine.
And so all of those are much lower in buprenorphine, which
is why it is Schedule III and able to be utilized in an OTP,
opioid treatment program.
Mr. Pallone. OK.
One of the bills that we are discussing today, H.R. 2872,
proposes bringing the regulations for physicians who prescribe
buprenorphine in their offices more in line with the
regulations governing methadone.
How would this proposal affect patients' access to
buprenorphine, or how would this proposal affect our ability to
treat special populations like pregnant women who are opiate-
dependent?
Dr. Waller. It would completely negate my ability to see my
patients, and I would have 200 people without treatment
immediately in my clinic.
If you look at this from a national perspective, we would
shut down any extension or expansion of this pathway, given the
amount of money that it takes to get into the pathway and in
the amount of regulations surrounding it.
So I think that it would be a--not just me. This is pretty
well understood that if that happened it would be catastrophic,
and the mortality rate would sky rocket.
Mr. Pallone. So, basically, it would profoundly affect our
ability to respond to the current opioid crisis, in your
opinion.
Dr. Waller. Unfortunately, yes.
Mr. Pallone. All right.
Now, another major access to--well, patients already face a
number of barriers in accessing medication-assisted treatment,
or MAT. And one major barrier to access MAT appears to be
cultural, social stigma surrounding the use of these
medications. Although there is strong evidence supporting the
use of MATs, many people, even within the treatment field,
continue to believe that using MATs is merely replacing one
addiction with another.
Can you comment on this perception? Are patients on MATs
merely replacing one opioid addiction with another?
Dr. Waller. The short answer is no.
But, very specifically, if we look at what we are trying to
do, the part of the brain that has been injured is the area
that releases a specific chemical called dopamine. These
medications re-regulate that so that we can add the beneficial
psychotherapies that then stabilize that for long-term.
Unfortunately, we have found that some patients who have
used this for an extended period of time, opioids and alcohol,
and at very high doses, they injure that part of the brain
permanently and that they may require stabilization of those
chemicals for a very long time and then sometimes lifetime.
We find that we don't keep all of our patients in my clinic
on this. We are able to wean a good number of them, but it
takes time. And the data is very clear that, at minimum, it is
18 months to 2 years before the brain begins to heal in that
setting.
Mr. Pallone. All right. Thanks a lot.
Thanks, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the gentleman from Indiana, Dr. Bucshon, 5 minutes
for questioning.
Mr. Bucshon. Thank you, Mr. Chairman. I appreciate it.
Thank you to all the witnesses for being here. Very much
appreciate it. This a big problem, obviously, that all of us
want to help solve.
I was a practicing cardiovascular and thoracic surgeon
prior to coming to Congress. And we are talking today primarily
about treatment, but we all know we also have to probably
address this on the front end with training of physicians,
beginning in medical school and residency. I can tell you, the
amount of training that I had, even as a surgeon, specifically
on pain management and the use of narcotics to manage pain was
really minimal other than, essentially, on-the-job training
during residency. And I think we nee to address that moving
forward.
I had a nice conversation with Michael Botticelli about an
hour ago, as you probably know, the Director of the Office of
National Drug Control Policy. And I guess President Obama will
be commenting on this specific subject in West Virginia
tomorrow, and I will be looking forward to his comments and
what they are planning to do to help all of us address this
situation.
I also want to comment on what Mr. Sarbanes said about
Naloxone. I think that it is important that especially first
responders and law enforcement and probably family members of
people who have these issues, as well as maybe the people
themselves, have access, with the appropriate training. I have
used Naloxone myself many times, primarily in intensive-care
units when we felt patients were overnarcotized. But there are
ramifications of using it, and we just need to make sure
everyone has the training. But I really agree with what Mr.
Sarbanes said.
The other thing is I think we need to recognize this goes
across age groups. For example, in 2013, the most commonly
prescribed drug under Medicare Part D was the generic version
of Vicodin--not an antibiotic, but a narcotic.
So, with that said, you know, I really appreciate all of
your comments today. And I agree with the team doctor, Dr.
Anderson, also. We need to address that situation going
forward.
Dr. Sledge, can you expand on your experience treating this
problem with the available current medications that are out
there? I mean, you obviously use other methods other than
medication treatment, but your experience at Cumberland also,
using those options also?
Dr. Sledge. Sure. And I appreciate the question. During the
assessment process, you know, we offer options as patients come
in, very clear with the course of treatment that we would
recommend at the time of the assessment. There are a myriad of
referents in the Nashville area if they choose to utilize a
different approach.
But we use buprenorphine, typically, to detox, to get the
patient opioid-free. And with a sufficient period of time,
which is very difficult to achieve in an outpatient setting,
but in a residential setting, with a sufficient period of time
of abstinence, we can begin to use a pure opioid antagonist or
an opioid blocker, if you will, naltrexone, and administer that
in an extended-release formulation that lasts for 30 days in
conjunction with their biopsychosocial----
Mr. Bucshon. OK. And Dr. Waller, I was interested in your
comments about 2872, since I am one of the ones that is working
on it. And thank you. With that we are still working through
this, trying to make sure, actually, we expand access to
treatment for patients, and we have a process we are going
through that we need to continually work on.
The one thing, though, I do, maybe slightly disagree on is,
that we should consider history, and we should consider money,
as part of a reason why to do or not to do things as it relates
to drug treatment. I understand the practical aspects of that.
So, I mean, what might you suggest? What would your
suggestions be to expand, really access to outpatient treatment
for these problems? Because, clearly, as you know, what we have
now, we have methadone, buprenorphine, and Naloxone--well,
naltrex--I keep confusing the two. You know what I am talking
about.
Dr. Waller. I do. Yes.
Mr. Bucshon. Vivitrol. I mean, we are trying to expand
access. If you don't think that we should make sure that
everyone is able to offer all of the options for treatment
medically, what should we do?
Dr. Waller. Well, no. I think that I may have misspoke or
been misunderstood. I think all three should be available for
sure. I use all three----
Mr. Bucshon. Yes.
Dr. Waller [continuing]. On a regular basis. I have a
number of patients on long-acting naltrexone, and we use it at
the time in which it is right for the patient. For some people,
it is right at the beginning. For my population in general,
though, it is toward the end of treatment as we stabilize them
on these other medications and let the psychosocial aspects
really start to work.
So the biggest thing that I think we have to do is make
sure that those of us who have access, and knowledge, and extra
training, and board certification in this area, much like you
did in your training, you wouldn't want a general surgeon doing
cardiothoracic surgery. You know, just like we want to be able
to help our colleagues in primary care by stabilizing these
complex patients and helping them to maintain them over a
period of time, and then in that fashion.
So I think bolstering the capability for the people who are
board certified and trained and focused on this illness to be
able to deliver services to a higher number of people, with all
of the medications, is of the utmost importance.
Mr. Bucshon. OK. Thank you. I yield back.
Mr. Pitts. The Chair thanks the gentleman, now recognizes
the gentlelady from Indiana, Mrs. Brooks, 5 minutes for
questions.
Mrs. Brooks. Thank you, Mr. Chairman, for holding this
hearing. And thank you all of the witnesses for coming today.
I specifically would like to thank Dr. Halverson for being
here. Welcome to Washington. It is an honor to have you before
the panel and always nice to have a fellow Hoosier in the
Nation's Capitol. And I have to admit, your experience--State
health director, CDC, now at IU Fairbanks School of Public
Health--we are very fortunate to have in you Indiana.
And in fact, I want to thank you, because Dr. Halverson
convened a roundtable, at IUPUI with prescribers, pharmacists,
members of HHS and VA, and we discussed the challenges Indiana
was facing then. As, unfortunately, one of the States leading
the country in prescription opioid and heroin drug abuse. And
we had quite a discussion that day, and we actually also had
someone from the med school who attended, and we appreciated
his participation.
But one thing that ONDCP, they released a report in 2011
that cited their intent to encourage medical and health
professional schools, such as Fairbanks, to continue expanding
the continuing education programs for prescribers. More
instruction on measuring pain and prescribing to treat it. Now,
that was 4 years ago. I think we are still really struggling in
the country with getting our medical schools and our continuing
medical education programs, embracing this concept. And could
you please discuss not only your efforts, but I would be
curious from the panel, what are we doing wrong? Why can we not
get our med schools and our continuing medical education and
other health educators to focus on the prescribing practices?
Dr. Halverson, would you please start. Because this is not
a new issue. ONDCP said it in 2011, so what challenges,
obstacles, what do we need to do to get our prescribers onboard
with this?
Dr. Halverson. Well, thank you, Representative Brooks. We
appreciate your interest specifically in this matter. I would
also say that the need is clear. It is my understanding we are
constantly looking at curriculum, and this is an important
issue. I have had conversations with our medical school dean
about this issue, but I also know that there are a whole lot of
other issues that are also in competition for that time. But I
also don't think there is any question about the importance of
this education.
Certainly, as we look in Indiana around issues of
continuing education and the need to inform all of the
prescribers around this issue, continuing education is not in
dispute. I think, really, it has been in the implementation,
particularly as it relates to reimbursement, and just the
logistics around getting it in place. But I don't think there
is any disagreement around the importance of the education.
Mrs. Brooks. Well, I have been involved in higher education
before coming to Congress, and I understand the curriculum
committees. There is a lot of discussion and a lot of work that
goes into providing curriculum. However, when our med schools
are saying they get 3 to 5 hours, possibly, in med school on
pain, it is just simply not enough. And at this point, to come
up with one set curriculum, I think, is a problem. Let's do
more.
And I am curious, do we need to be requiring it? Does it
need to be mandatory? Should there be certain hours that all
prescribers are required to take a year?
I am a lawyer. We have continuing legal education credits
that we are required to have every year. There are some
requirements--what do the other panelists think? This is very
troublesome for me. Not just for physicians, but nurses,
dentists, others who are prescribers. What should we be doing?
Any ideas of what can we do to fix this problem? Because we
have been talking about it far too long and our educators
haven't resolved the issue.
Dr. Waller. So, two very practical possible solutions, and
one is to consolidate the efforts of adding to the curriculum
for pain and addiction based on the governing body for the
national medical schools rather than having a heterogeneous
group of medical schools come up with their own curriculum.
This curriculum has already been developed by SAMHSA as
well as CMS, and has put out there as a recommended curriculum.
It is there, access to it online for free is available in many
locations, so you don't even have to have your own specialist.
But you need to have the mandate within the medical schools
that this is a part of the curriculum. It is currently not.
Mrs. Brooks. And unlike my colleague, Dr. Bucshon, who went
to med school, I did not, so I don't know what is mandated. Are
there other parts in the medical education that are mandated,
or is it all left up to each individual med school? I am
certain there must be a lot of mandatory curriculum items. Can
you give us a couple of examples of a couple of them, and why
wouldn't this be one of them?
Dr. Waller. Well, a specific example is, every medical
student has to rotate through the core curriculum, and the core
curricula hasn't changed, in 100 years almost. I mean, when you
look at it, it is internal medicine; it is general surgery, and
then it is the connections between all of those. Pediatrics,
and then you rotate through the critical care, the inpatient
care, and the outpatient care of each of those. Adding on the
specialties has always been an option. And they have seen
addiction medicine and pain medicine as a high-end specialty
for which many don't have access to rotate.
So until you mandate it as a part of the clinical
curriculum so they actually stand next to somebody doing this,
there is no way for them to glean from a book how hard it is to
talk to some of these patients who have had a horrible early
life, and they have to see it. And if you mandate that, they
will find it, because there are people everywhere, there is a
medical school. There is someone who is board certified in pain
or addiction to do this.
And then, I am sorry, my friends are not going to like me
for this, but I think that physicians who prescribe controlled
substances should be mandated to have ongoing, you know, CME,
period. And ASAM agrees with that.
Mrs. Brooks. I would be curious--and I see that my time is
up, but, Mr. Chairman, if I could just ask the panel, I would
be curious if anyone on the panel disagrees with that notion?
Dr. Sledge. No.
Dr. Katz. No, absolutely not.
Mrs. Brooks. Sir?
Dr. Anderson. I don't disagree.
Mrs. Brooks. Thank you. With that, I yield back, Mr.
Chairman.
Mr. Pitts. The Chair thanks the gentlelady.
Now, without objection, the gentleman, Mr. Tonko, a member
of the full committee, is recognized for 5 minutes for
questions.
Mr. Tonko. Thank you, Mr. Chairman.
Thank you for the thoughtful discussion by the panelists
and to the many in the room who make it their passion to end
this epidemic.
I understand that the Drug Addiction Treatment Act of 2000,
or DATA 2000, was passed to expand access to addiction
treatment, across geographic boundaries, and populations by
integrating it into the general medical setting.
So for Dr. Waller, can you describe how DATA 2000 expanded
access to addiction treatment services in the United States?
Dr. Waller. Yes, sir. And, again, Congressman Tonko, thank
you for all your hard work in this area. It is greatly
appreciated.
Mr. Tonko. Well, we have good partners, so----
Dr. Waller. So one of the things that it has done, is it
has allowed for clinics such as mine, which I work for a
medical system. I am an employee of a hospital system, to be
able to open our doors and see patients based on a referral, in
an outpatient setting, and then deliver the highest quality of
care. So it allows for a specialist like me to work in a
standard medical setting and deliver care to patients, both for
pain and addiction, and all of the psychosocial aspects.
From a primary care aspect, it does allow them to treat in
place. And especially in our rural areas of America, which is
the largest part of America, there are no methadone clinics.
There are no inpatient treatment facilities for hundreds of
miles in many places. And in my home State, Michigan, we have
an Upper Peninsula that is devoid of treatment. They don't have
a buprenorphine prescriber in the entire Upper Peninsula now.
This is a large portion of the population that is left without.
So, being able to not make this feel like a criminal act to
write this medication for patients, not be fearful of the DEA
walking into your office while you are seeing a patient for
hypertension to write buprenorphine, and then the availability
of the medication to prescribe in a thoughtful, safe way is
key. It is expanded in many areas, but we still have a lot to
go, and it is for all of those reasons I just stated.
Mr. Tonko. Well I say this in terms of expanding it, the
law expanded access to buprenorphine in some ways, but the law
did set certain limits. And it is clear from the current opioid
crisis that we have outgrown those rules. And as you know, in
2012, 96 percent of our States and the District of Columbia had
opioid abuse or dependence rates higher than their
buprenorphine treatment capacity rates.
So I am concerned that the opioid crisis has outgrown those
rules. Could you explain how the current cap of 100 patients,
Dr. Waller, has limited our ability to respond to the current
opioid epidemic?
Dr. Waller. Yes. We have two areas that we have dug in
pretty deeply above the national level, and me at the local
level. One is the first year, you can only see 30. You take
your 8 hours of education and make sure that you finish the
test and then you get your certification to see 30 patients.
The next year you can apply for 100. For that, those of us who
were specialty trained capped out at 100 pretty quickly,
because the vast majority of the patients funnel to us. And so
we capped very early within our areas.
In primary care, we have a large percentage of doctors who
have chosen not to write for this medication, despite having an
X license. And so what it looks like is we have a large amount
of capacity. Well, we have 423 primary care doctors in my
medical group, and I have talked to over 300 of them to find
out why they won't write this medication in their practice.
And it is consistent. They don't feel like they have the
training. They don't feel like they have the support to
evaluate and initiate treatment in patients and then stabilize
them. They feel comfortable with the maintenance as long as
they know they have backup. But the reason that we don't see a
lot of primary care doctors raising that, you know, seeing up
to 100 patients, or seeing the 30, is because they don't feel
like they have the appropriate knowledge and backup. When we
have offered that, we have seen, they do a really good job with
this. I mean, once they learn about the disease, their ability
to treat it is really good.
But it needs to be stabilized in a specialty setting and
then handed off. Therefore, raising the cap for people who do
this as a specialty, and have board certifications then it
would allow us to then hand some of our patients off to primary
care over time but then allow us to not have a barrier, in my
case, a 7-month waiting list to see patients.
Mr. Tonko. And do you have an opinion on the current
prohibition of certain--other professionals that might assist
here, prohibition on nonphysician providers prescribing
buprenorphine, including nurse practitioners, physician
assistants? Does that limit patient access?
Dr. Waller. It absolutely does. I have two PA, physicals
assistants, in my office who are the backbone of my patient
evaluation. They are seeing patients as I am sitting here. But
we are limited in what they can do. So if I had an urgent
intake, they are frozen. They can't see a new patient and start
them on buprenorphine, even if they are under my supervision. I
can't pick up a phone, they don't have the legal right to write
that prescription.
So, starting this in a way in which is appropriately
supervised and so that they have somebody to go to for the
difficult patients and can onboard this knowledge and training
is very important. But the access for them to be able to write
these from a practical standpoint, it really just has to
happen. They are really moving forward the biggest part of our
healthcare system.
Mr. Tonko. Thank you. With that, I yield back. Mr. Chair,
thank you very much.
Mr. Pitts. The Chair thanks the gentleman. That concludes
the questions of the members who are present. There will be
other members who have questions and follow-ups that we will
send you in writing. We ask that you would please respond
promptly. Members should submit their questions by the close of
business on Tuesday, November the 3rd. So members have 10
business days to submit the questions for the record.
Very informative and important issues we are dealing with.
Thank you for your expert testimony. It will help us as we
proceed to move the legislation, the subject of the hearing.
And I want to thank each of you for coming and presenting the
expert testimony today.
Without objection, the subcommittee is adjourned.
[Whereupon, at 5:12 p.m., the subcommittee was adjourned.]
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