[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]

WARNING: THE GROWING DANGER OF PRESCRIPTION DRUG DIVERSION

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

HEARING

BEFORE THE

SUBCOMMITTEE ON COMMERCE, MANUFACTURING, AND TRADE

OF THE

COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES

ONE HUNDRED TWELFTH CONGRESS

FIRST SESSION

__________

APRIL 14, 2011

__________

Serial No. 112-39

Printed for the use of the Committee on Energy and Commerce

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COMMITTEE ON ENERGY AND COMMERCE

FRED UPTON, Michigan
Chairman

JOE BARTON, Texas HENRY A. WAXMAN, California
Chairman Emeritus Ranking Member
CLIFF STEARNS, Florida JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania EDOLPHUS TOWNS, New York
MARY BONO MACK, California FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska MICHAEL F. DOYLE, Pennsylvania
MIKE ROGERS, Michigan ANNA G. ESHOO, California
SUE WILKINS MYRICK, North Carolina ELIOT L. ENGEL, New York
Vice Chair GENE GREEN, Texas
JOHN SULLIVAN, Oklahoma DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania LOIS CAPPS, California
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas
BRIAN P. BILBRAY, California JAY INSLEE, Washington
CHARLES F. BASS, New Hampshire TAMMY BALDWIN, Wisconsin
PHIL GINGREY, Georgia MIKE ROSS, Arkansas
STEVE SCALISE, Louisiana ANTHONY D. WEINER, New York
ROBERT E. LATTA, Ohio JIM MATHESON, Utah
CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
GREGG HARPER, Mississippi JOHN BARROW, Georgia
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin
BRETT GUTHRIE, Kentucky Islands
PETE OLSON, Texas
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia

7_____

Subcommittee on Commerce, Manufacturing and Trade

MARY BONO MACK, California
Chairman
MARSHA BLACKBURN, Tennessee G.K. BUTTERFIELD, North Carolina
Vice Chairman Ranking Member
CLIFF STEARNS, Florida CHARLES A. GONZALEZ, Texas
CHARLES F. BASS, New Hampshire JIM MATHESON, Utah
GREGG HARPER, Mississippi JOHN D. DINGELL, Michigan
LEONARD LANCE, New Jersey EDOLPHUS TOWNS, New York
BILL CASSIDY, Louisiana BOBBY L. RUSH, Illinois
BRETT GUTHRIE, Kentucky JANICE D. SCHAKOWSKY, Illinois
PETE OLSON, Texas MIKE ROSS, Arkansas
DAVID B. McKINLEY, West Virginia HENRY A. WAXMAN, California (ex
MIKE POMPEO, Kansas officio)
ADAM KINZINGER, Illinois
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)

(ii)

C O N T E N T S

----------
Page
Hon. Mary Bono Mack, a Representative in Congress from the State
of California, opening statement............................... 1
Prepared statement........................................... 3
Hon. Charles A. Gonzalez, a Representative in Congress from the
State of Texas, opening statement.............................. 4
Hon. Mike Pompeo, a Representative in Congress from the State of
Kansas, prepared statement..................................... 5
Hon. Brett Guthrie, a Representative in Congress from the
Commonwealth of Kentucky, prepared statement................... 6
Hon. Pete Olson, a Representative in Congress from the State of
Texas, prepared statement...................................... 6
Hon. Gregg Harper, a Representative in Congress from the State of
Mississippi, prepared statement................................ 6
Hon. David B. McKinley, a Representative in Congress from the
State of West Virginia, prepared statement..................... 7
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, prepared statement......................... 7
Hon. Edolphus Towns, a Representative in Congress from the State
of New York, opening statement................................. 7
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 296
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 297
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, prepared statement................................ 299

Witnesses

R. Gil Kerlikowske, Director, Office of National Drug Control
Policy......................................................... 9
Prepared statement........................................... 11
Answers to submitted questions............................... 301
Michele M. Leonhart, Administrator, Drug Enforcement
Administration................................................. 17
Prepared statement........................................... 19
Answers to submitted questions............................... 305
Rick Scott, Governor, State of Florida........................... 41
Prepared statement........................................... 44
Steve Beshear, Governor, Commonwealth of Kentucky................ 51
Prepared statement........................................... 53
Phil Bauer, father of Mark Bauer and Parents Advisory Board
member, Partnership at Drugfree.org............................ 82
Prepared statement........................................... 85
Kathy Creedon, mother of Ryan Creedon and founder, Mothers
Against Prescription Drug Abuse, accompanied by Courtney
Creedon, sister of Ryan Creedon................................ 91
Prepared statement........................................... 93
April Rovero, mother of Joey Rovero, and founder, National
Coalition Against Prescription Drug Abuse, and Parent
Ambassador, Partnership at Drugfree.org........................ 102
Prepared statement........................................... 104
Dan Harrison, Drug Court graduate................................ 111
Prepared statement........................................... 113
Carol J. Boyd, Director, Institute for Research on Women and
Gender, and Professor of Nursing, University of Michigan, Ann
Arbor.......................................................... 119
Prepared statement........................................... 121
Answers to submitted questions............................... 321
Amelia M. Arria, Director, Center on Young Adult Health and
Development, University of Maryland............................ 158
Prepared statement........................................... 160
Answers to submitted questions............................... 330
Sean Clarkin, Executive Vice President and Director of Strategy,
Partnership at Drugfree.org.................................... 175
Prepared statement........................................... 178
Arthur T. Dean, Chairman and Chief Executive Officer, Community
Anti-Drug Coalitions of America................................ 186
Prepared statement........................................... 188
John M. Coster, Senior Vice President, Government Affairs,
Generic Pharmaceutical Association............................. 211
Prepared statement........................................... 213
Answers to submitted questions............................... 340
Kendra Martello, Assistant General Counsel, Pharmaceutical
Research and Manufacturers of America.......................... 221
Prepared statement........................................... 223
Answers to submitted questions............................... 345
Michael S. Mayer, President, MedReturn, LLC...................... 236
Prepared statement........................................... 238
Patrick Coyne, Clinical Director, Thomas Palliative Care Unit,
Virginia Commonwealth University Medical Center, on behalf of
the Oncology Nursing Society................................... 250
Prepared statement........................................... 252
Answers to submitted questions............................... 356

Submitted Material

Article, ``UW a force in pain drug growth,'' by John Fauber of
the Journal Sentinel, dated April 2, 2011, submitted by Mrs.
Bono Mack...................................................... 71
Letter, dated April 11, 2011, from George Doyle, President and
CEO, Boehringer Ingelheim Roxane, Inc., to Hon. Michele
Leonhart, Administrator, Drug Enforcement Administration,
Department of Justice, submitted by Mrs. Bono Mack............. 265
Report, ``The Importance of On-Dose Technologies in the Fight
Against Misuse, Abuse and Illegal Diversion of Opioids,'' by
John Glover, undated, submitted by Mrs. Bono Mack.............. 267
Statement, dated April 2011, of the National Association of Chain
Drug Stores, submitted by Mrs. Bono Mack....................... 278
Statement, dated April 14, 2011, of the National Community
Pharmacists Association, submitted by Mrs. Bono Mack........... 284
Letter, dated April 13, 2011, from American Academy of Pain
Management et al., to Mrs. Bono Mack and subcommittee members,
submitted by Mrs. Bono Mack.................................... 289
Statement, dated April 14, 2011, of Hon. Harold Rogers, a
Representative in Congress from the Commonwealth of Kentucky,
submitted by Mrs. Bono Mack.................................... 292

WARNING: THE GROWING DANGER OF PRESCRIPTION DRUG DIVERSION

----------

THURSDAY, APRIL 14, 2011

House of Representatives,
Subcommittee on Commerce, Manufacturing, and Trade,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 8:05 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Bono Mack
(chairman of the subcommittee) presiding.
Members present: Representatives Bono Mack, Blackburn,
Stearns, Harper, Lance, Cassidy, Guthrie, Olson, McKinley,
Pompeo, Kinzinger, Butterfield, Gonzalez, Towns and Inslee.
Staff present: Paul Cancienne, Policy Coordinator,
Commerce, Manufacturing, and Trade; Brian McCullough, Senior
Professional Staff Member, Commerce, Manufacturing, and Trade;
Gib Mullan, Chief Counsel, Commerce, Manufacturing, and Trade;
Anita Bradley, Senior Policy Advisor, Chairman Emeritus;
Shannon Weinberg, Counsel, Commerce, Manufacturing, and Trade;
Alex Yergin, Legislative Clerk; Michelle Ash, Democratic Chief
Counsel; and William Wallace, Democratic Policy Analyst.
Mrs. Bono Mack. Good morning. The subcommittee can now
please come to order.
Someone once said, I would like mornings better if they
started later, and amen to that, especially as a Californian.
But I truly appreciate the effort that everyone has made to be
here for a somewhat unprecedented 8:00 in the morning hearing,
although as I said, as a Californian, my clock still says it is
5:00 in the morning.
But seriously, when it comes to the topic at hand, there is
no better time than right now to discuss it. Today,
prescription drug abuse is a deadly serious and rapidly
escalating problem all across America. We have an obligation to
tackle it head on. The chair now recognizes herself for an
opening statement.

OPENING STATEMENT OF HON. MARY BONO BACK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA

Since 2003, more than 5,000 U.S. service men and women have
died in Iraq and Afghanistan. As Americans, we celebrate their
lives and we mourn their deaths. They will always be remembered
by a grateful nation.
Yet today, there is a mostly forgotten war also being
fought right here at home in both small towns and large cities
all across the United States. This costly and rapidly
escalating struggle against prescription drug abuse and
addiction is expected to claim the lives of some 30,000
Americans this year alone.
For the most part, this battle is being waged in remote
outposts of the human mind, where scientists now tell us that
childhood trauma, genetics, mental disorders, stress, thrill
seeking, social pressures, severe pain from injuries and
illnesses, and, yes, the horrors of combat, all contribute to
devastating addictions, which in turn, all too often lead to
tragic and avoidable deaths. But what is even more insidious is
the way these powerfully addictive drugs quickly turn people
without any real emotional or physical problems into desperate
people suddenly facing life-or-death problems. Few things are
more destructive.
According to the Centers for Disease Control, drug overdose
is the second leading cause of accidental death in the United
States, in large part due to prescription drug abuse, and the
problem is growing every single day. According to a recent
national survey, some 7 million people age 12 or older
regularly abuse prescription drugs, and there are approximately
7,000 new abusers every single day, many of them teenagers and
young adults. That alarming trend is taking a huge toll on
society.
Today, the abuse of prescription drugs, especially
painkillers, stimulants and depressants, is the fastest-growing
drug problem in America. As someone who has been deeply and
personally affected by this issue, I hope today's hearing will
lead to a better understanding of the enormous scope of this
problem, the staggering costs, both emotionally and
financially, that it imposes on families and communities, and
the need for a greater sense of urgency as a Nation in
addressing it.
I believe one critically important first step is to do a
better job of monitoring and limiting access to prescription
drugs containing controlled-released oxycodone hydrochloride,
including the popular painkiller OxyContin. Originally,
OxyContin was intended to be prescribed only for severe pain as
a way to help patients dealing with late-stage cancer and other
severe illnesses. Today, however, more and more people across
America are being prescribed OxyContin, as well as other
generic oxycodone drugs, for less severe reasons, clinically
known as moderate pain, greatly expanding the availability and
potential for abuse of these powerfully addictive narcotics.
For people all across America, prescription drug abuse is a
day-to-day struggle. Over time, it destroys families and wreaks
havoc on communities all across the Nation. Someone with a
toothache or a sore back should not be prescribed a potentially
addictive painkiller. I agree that expanded public education
plays a role in addressing the problem, but we are not going to
make any real progress until we limit access to these powerful
narcotic drugs and ensure that only patients in severe pain can
obtain them.
The pervasiveness of prescription drug abuse made national
headlines recently when Federal, State, and local law
enforcement agencies, led by the Drug Enforcement Agency,
cracked down on so-called ``pill mills'' in Florida, resulting
in dozens of arrests, including five doctors.
Congress needs to make it much more difficult for these
rogue pain clinics to operate, and we should treat offenders
like any other street drug dealer. By better coordinating the
efforts of local, State and national agencies and by reducing
the supply of highly addictive opioid painkillers, I am
convinced that we can eventually save thousands of lives and
spare millions of families from the headache and heartache of
addiction.
A recent Denver Post article highlighted why these powerful
drugs are so attractive to thieves, drug dealers and
unscrupulous doctors. According to the Post, OxyContin costs $1
per milligram on the street and comes in doses ranging from 15
to 80 milligrams. So a dealer selling 1,000 tablets can make up
to $80,000.
What does that mean in human terms? Well, a recent report
by the National Institute on Drug Abuse has found that nearly
one in 20 high school seniors have reported abuse of OxyContin.
And yet another disturbing report by the Substance Abuse and
Mental Health Services Administration shows a staggering 400
percent increase in admissions of people aged 12 years and
older for treatment of prescription drug abuse between 1998 and
2008. Clearly, we have a daunting challenge in front of us.
I would like to thank all of our distinguished panelists,
especially DEA Administrator Leonhart, ONDCP Director
Kerlikowske, Governor Scott and Governor Beshear for their
personal commitment to this important issue. If we are going to
win the war against prescription drug abuse, we must all serve
as soldiers.
[The prepared statement of Mrs. Bono Mack follows:]

Prepared Statement of Hon. Mary Bono Mack

Since 2003, more than 5,000 U.S. service men and women have
died in Iraq and Afghanistan. As Americans, we celebrated their
lives and mourned their deaths. They will always be remembered
by a grateful nation.
Yet today, there is a mostly forgotten war also being
fought--right here at home--in both small towns and large
cities all across the United States. This costly and rapidly
escalating struggle against prescription drug abuse and
addiction is expected to claim the lives of some 30,000
Americans this year alone.
For the most part, this battle is being waged in remote
outposts of the human mind, where scientists now tell us that
childhood trauma, genetics, mental disorders, stress, thrill
seeking, social pressures, severe pain from injuries and
illnesses, and, yes, the horrors of combat--all contribute to
devastating addictions, which in turn all too often lead to
tragic and avoidable deaths.
But what's even more insidious is the way these powerfully
addictive drugs quickly turn people without any real emotional
or physical problems into desperate people suddenly facing
life-or-death problems. Few things are more destructive.
According to the Centers for Disease Control, drug overdose
is the second leading cause of accidental death in the United
States--in large part due to prescription drug abuse. And the
problem is growing every single day.
According to a recent national survey, some 7 million
people age 12 or older regularly abuse prescription drugs, and
there are approximately 7,000 new abusers every day--many of
them teenagers and young adults. That alarming trend is taking
a huge toll on society.
Today, the abuse of prescription drugs--especially
painkillers, stimulants, and depressants--is the fastest-
growing drug problem in America. As someone who has been deeply
and personally effected by this issue, I hope today's hearing
will lead to a better understanding of the enormous scope of
this problem, the staggering costs--both emotionally and
financially--that it imposes on families and communities, and
the need for a greater ``sense of urgency'' as a nation in
addressing it.
I believe one critically important first step is to do a
better job of monitoring and limiting access to prescription
drugs containing controlled-release oxycodone hydrochloride,
including the popular pain killer OxyContin.
Originally, OxyContin was intended to be prescribed only
for severe pain as a way to help patients dealing with late-
stage cancer and other severe illnesses. Today, however, more
and more people across America are being prescribed OxyContin,
as well as other generic oxycodone drugs, for less severe
reasons--clinically known as moderate pain--greatly expanding
the availability and potential for abuse of these powerfully
addictive narcotics.
For people all across America, prescription drug abuse is a
day-to-day struggle. Over time, it destroys families and wreaks
havoc on communities all across the nation. Someone with a
toothache or a sore back should not be prescribed a potentially
addictive painkiller. I agree that expanded public education
plays a role in addressing the problem, but we're not going to
make any real progress until we limit access to these powerful
narcotic drugs and ensure that only patients in severe pain can
obtain them.
The pervasiveness of prescription drug abuse made national
headlines recently when Federal, state, and local law
enforcement agencies, led by the Drug Enforcement Agency,
cracked down on so-called ``pill mills'' in Florida, resulting
in dozens of arrests--including five doctors.
Congress needs to make it much more difficult for these
rogue pain clinics to operate, and we should treat offenders
like any other street drug dealer. By better coordinating the
efforts of local, state and national agencies--and by reducing
the supply of highly addictive opioid painkillers--I am
convinced that we can eventually save thousands of lives and
spare millions of families from the heartache of addiction.
A recent Denver Post article highlighted why these powerful
drugs are so attractive to thieves, drug dealers and
unscrupulous doctors. According to the Post, Oxycontin costs $1
per milligram on the street and comes in doses ranging from 15
to 80 milligrams. So a dealer selling 1,000 tablets can make up
to $80,000.
What does this mean in human terms? Well, a recent report
by the National Institute on Drug Abuse has found that nearly 1
in 20 high school seniors have reported abuse of OxyContin.
And yet another disturbing report by the Substance Abuse
and Mental Health Services Administration shows a staggering
400 percent increase in admissions of people aged 12 years and
older for treatment of prescription drug abuse between 1998 and
2008.
Clearly, we have a daunting challenge in front of us. I
would like to thank all of our distinguished panelists--
especially DEA Administrator Leonhart, ONDCP Director
Kerlikowske, Governor Scott, and Governor Beshear--for your
personal commitments to this important issue.
If we are going to win the war against prescription drug
abuse, we must all serve as soldiers.

Mrs. Bono Mack. The gentleman from Texas is now recognized
for 5 minutes for an opening statement.

OPENING STATEMENT OF HON. CHARLES A. GONZALEZ, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS

Mr. Gonzalez. Madam Chair, thank you very much, and thank
you for calling this most important hearing and for inviting so
many experts that will create our four distinguished panels of
witnesses.
I need to apologize because I will be absent for part of
the hearing and hopefully will be returning, but at around 8:30
I will have to go to another presentation and hopefully come
back, but we should have some members on our side of the aisle.
I also wish to extend the apologies of ranking members
Butterfield and Waxman, who are disappointed that they cannot
be here at this time, obviously due to a conflict in
commitments.
According to the 2010 National Drug Control Strategy, the
fastest growing form of substance abuse in the United States is
the non-medical use of prescription drugs including opiates,
pain relievers, tranquilizers, sedatives and stimulants. Under
the careful supervision of a doctor, these medications can
alleviate severe pain or help those suffering from mental
disorders like psychosis, depression, anxiety, insomnia or
attention deficit hyperactivity disorder.
Teens and young adults are increasingly susceptible to
prescription drug abuse. Seven out of the top 10 substances
most abused by young people are prescription medications. Like
their older counterparts, teens most frequently obtain non-
medical pain relievers, tranquilizers and stimulants from a
friend or a family member. Despite popular misconceptions to
the contrary, research indicates that even teens and young
adults misuse prescription drugs not just to get high but for a
variety of reasons. The Partnership for a Drug-Free America
answers that teens do so to party, to get high in some cases
but also to manage or regulate their lives. They are abusing
some prescription stimulants to give them additional energy and
ability to focus when they are studying or taking tests. They
are abusing prescription pain relievers and tranquilizers to
cope with academic, social or emotional stress.
Many teenagers draw key distinctions between these drugs
and illicit street drugs, characterizing their use of
prescription drugs as responsible, controlled or even safe.
Researchers have concluded that the growing popularity of
prescription drugs also reflects the perception that these
drugs are safer than street drugs. There are several programs
at the Federal, State, and local level that seek to curb
prescription drug abuse and diversion.
I look forward to the testimony of our witnesses so that we
may determine what is working and what more can be done to stop
the growing problems. And Madam Chair, unlike many of the
hearings we have, and we have such contentious differences of
opinion, I don't think we are going to have that today. I think
we are just going to try to identify what works and that we
move forward and lend the assistance at the Federal level to
everyone out there in attempting to curb a very serious
problem, and I yield back at this time.
Mrs. Bono Mack. I thank the gentleman for his words and for
the spirit with which he said them, and now the chair
recognizes Mr. Pompeo for 1 minute.

OPENING STATEMENT OF HON. MIKE POMPEO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF KANSAS

Mr. Pompeo. Thank you, Madam Chair.
I just briefly want to say thank you for holding this
hearing. Thanks for bringing attention to this incredibly
important issue. I am the father of a 20-year-old son. I know
the kinds of things he is seeing at Kansas University. I know
the kinds of challenges that young people have, and I look
forward to your testimony this morning so that we can get the
facts, learn a little bit about what works so that we can
develop good Federal policy that will minimize the risk from
this very real concern that I think lots of parents have all
across the country.
So thank you all for coming this morning. Thank you, Madam
Chairwoman. I yield back the balance of my time.
Mrs. Bono Mack. I thank the gentleman, and the chair
recognizes Mr. Guthrie for 1-1/2 minutes.

OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

Mr. Guthrie. Thank you, Madam Chairman. I won't take too
much time because I will speak a little later when our governor
is here in the next panel. But I just want to thank you for
bringing attention to this issue. It is important. It is
important in my State, like all States, but we particularly
have a problem and we are looking forward to the next panel,
but I just wanted to say thank you so much for having this
hearing today.
Mrs. Bono Mack. I thank the gentleman, and recognize the
gentleman from Texas, Mr. Olson, for 1-1/2 minutes.

OPENING STATEMENT OF HON. PETE OLSON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS

Mr. Olson. I am pleased to be here early this morning, and
I thank the chair for her leadership in holding this hearing to
shed light on a problem of prescription drug diversion and
abuse. I know this issue is greatly important to the chair, and
I commend her on assembling an impressive group of witnesses.
Prescription drug abuse in America is not an issue we
should take lightly. As a parent of two children, it is very
concerning to me to see statistics showing that on a daily
basis 2,500 American teenagers are trying prescription drugs
for the first time, 2,500 per day. The vast majority of these
teens are getting drugs from their own house, taking them from
their parents' medicine cabinet and using them or giving them
to friends. Given this, it is so important that parents are
educated about the risks of prescription drug abuse in addition
to knowing about and utilizing drug disposal and take-back
programs.
I thank the chair for her commitment to America's youth and
I look forward to hearing from our witnesses. I yield back.
Mrs. Bono Mack. I thank the gentleman, and the chair
recognizes Mr. Harper for 30 seconds.

OPENING STATEMENT OF HON. GREGG HARPER, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MISSISSIPPI

Mr. Harper. Thank you, Madam Chair, and I certainly welcome
the witnesses. It is quite an impressive lineup. We look
forward to hearing what each has to say today.
This is an important issue, and it has devastated families
that I know back home. Spending years as a prosecutor, you see
what it does to many unintended victims in this, and I just
look forward to looking for solutions and ways that we can
solve this and help these families, and I want to thank you,
Madam Chair, for holding this very important hearing.
Mrs. Bono Mack. I thank the gentleman. Everybody is so
happy this morning. The chair recognizes Mr. McKinley for 30
seconds.

OPENING STATEMENT OF HON. DAVID B. MCKINLEY, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF WEST VIRGINIA

Mr. McKinley. Thank you, Madam Chairman, and I join that. I
thank you for holding this hearing this morning on this topic.
As a father of four and a grandfather of six, I see what they
are going to be facing. I saw what happened in our society back
in the 1960s. It wasn't pretty, and what these kids are facing
today is shocking.
My wife is a critical care nurse and works in the emergency
room of a hospital, and she tells me time and time again of the
horrors, so many people come in that have abused the drugs and
what it is doing to our Nation.
So I welcome you and thank you very much for holding this
hearing so we can learn more how we can address this and save
our next generation. Thank you very much.
Mrs. Bono Mack. I thank the gentleman, and the chair is
pleased to recognize the vice chair of the committee, Ms.
Blackburn, for 30 seconds.

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

Mrs. Blackburn. And thank you, Madam Chairman.
Welcome to our witnesses, and thank you all for being here
with us today.
There are three points that I think that as we work through
what is an emotional debate that we need to be thinking about.
First, to what extent should duly licensed prescription drug
manufacturers be required to spend time, money and resources on
trying to envision every new way that their product might be
abused? Secondly, if we begin to restrict the approval of new
prescription drugs, what impact will it have on patients who
desperately rely on them to cope with debilitating pain and are
just trying to make it through another day? And perhaps the
most important question is, How do we deal with personal and
parental responsibility? And I yield back.
Mrs. Bono Mack. I thank the gentlelady, and the chair
recognizes the gentleman from New York, Mr. Towns, for 5
minutes.

OPENING STATEMENT OF HON. EDOLPHUS TOWNS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW YORK

Mr. Towns. Thank you very much, Madam Chair. Let me thank
you and Congressman Butterfield for having this hearing and
also I want to thank Congressman Gonzalez for filling in on his
behalf.
This is a very serious issue, and I am very pleased,
however, that a number of provisions in the recently enacted
Patient Protection and Affordable Care Act could yield some
very positive results in our efforts to curb this growing
problem.
We must educate families about the dangers of loose
prescription drugs in their households. We must also utilize
other relevant Federal laws and procedures in order to
safeguard against prescription drug diversion. Some of these
safeguards include a recently proposed risk evaluation and
mitigation strategy. If implemented by the FDA, this strategy
could train prescribers, catalog patient information and
administer periodic effectiveness assessment tests. Other
safeguards would involve improving the communication abilities
of our law enforcement officials, doctors, pharmaceutical
dispensers so that frequent abusers can be brought to justice.
Tackling the growing danger of prescription drug abuse will
require bipartisan support, and that is the reason I was happy
to hear the comment made by Congressman Gonzalez, that we are
all on the same team when it comes to these kinds of things and
when it comes to protecting our young people, and I am really
happy about that.
This public health issue requires the input and resources
of all relevant stakeholders to ensure this problem is fully
addressed. This is not one that we should get involved in the
blame game. I think there is enough blame here for everybody to
share. I think it is time to come together to see in terms of
what we can do on both sides of the aisle, of course, every
stakeholder that is involved in this issue, because this is an
issue that if blame would solve it, then it would not even be
here because of all the years we have been complaining about
it.
But I think the time now has come when we must roll up our
sleeves and together work to see what we can do to be able to
curtail the fact that especially with our young people who the
numbers seem to keep going up and up.
I look forward to hearing from our witnesses today and
working with my colleagues to ensure Congress plays a vital
role in protecting families from the growing danger of
prescription drugs. And let me say to the chairperson that I
really, really appreciate her involvement here and hope that we
will continue to work together to see in terms of what we might
be able to do to protect the lives of many of our young people
who have gotten involved in this and of course I think that we
can do a lot better.
Thank you very much. I yield back.
Mrs. Bono Mack. I thank the gentleman, and now to move to
the panel. We have the first panel, one of four that will be
before us today. Each of the witnesses has prepared an opening
statement that will be placed in the record. Each of you will
have 5 minutes to summarize that statement in your remarks.
On our first panel, I am honored that we would have these
two distinguished witnesses, the Hon. Gil Kerlikowske. When I
first met him, I couldn't say the name and so I have come a
long way. Hon. Gil Kerlikowske, Director of the Office of
National Drug Control Policy, and the Hon. Michele Leonhart,
Administrator of the Drug Enforcement Agency.
Good morning to both of you, and thank you for your hard
work, and you will each be recognized for 5 minutes. You
probably know the drill. There are lights over there, and as
they are green, you are well on your way. When you see the
yellow lights, you are down to the wrap-up time, and when you
hit red on the light, if you could then sum up your comments
and we will then move on to the next witness.
So Director Kerlikowske, you may begin with your first 5
minutes. Thank you.

STATEMENTS OF R. GIL KERLIKOWSKE, DIRECTOR, OFFICE OF NATIONAL
DRUG CONTROL POLICY; AND MICHELE M. LEONHART, ADMINISTRATOR,
DRUG ENFORCEMENT ADMINISTRATION

STATEMENT OF GIL KERLIKOWSKE

Mr. Kerlikowske. Well, thank you, Ms. Chairman Bono Mack,
and thank you, Ranking Member Gonzalez and the distinguished
members of the committee for the opportunity to address
prescription drug issues.
I really applaud the committee's focus on this topic.
Prescription drug abuse has been a major focus since my
confirmation, and I have directed that the national drug
control program agencies address this epidemic in our country.
Let me pause for a minute. As a long-time police chief in
Seattle for 9 years, I paid attention to what caused harm in my
community. Quite frankly, the abuse of prescription drugs
wasn't on my radar screen, and quite frankly, I believe that
around the country this has not received the attention that it
needs.
As the President's chief advisor on drug policy, this
position demands that I raise public awareness and take action
on drug issues affecting the Nation. The efforts in the
President's drug control strategy are balanced. They
incorporate new research, evidence-based approaches to address
drug use and its consequences.
In 2008, over 23 million Americans ages 12 or older needed
treatment for an illicit drug or alcohol use problem. However,
only 11 percent received that necessary treatment for that
substance use disorder.
Well, today I am here to talk about prescription drug
abuse. Prescription drug abuse, as was mentioned, is the
fastest growing drug problem in the United States and it is
categorized as a public health epidemic by the Centers for
Disease Control and Prevention, and in recent years the number
of individuals who for the first time consumed prescription
drugs for non-medical purposes was similar to the number of
first-time marijuana users. The 2010 Monitoring the Future, a
national survey on youth drug use, found that six of the top 10
substances used by 12th graders were pharmaceuticals. We have
also seen a fourfold increase in addiction treatment admissions
for individuals, primarily abusing prescription painkillers.
That was from 1997 to 2007. And even more alarming is the fact
that over the last 5 years, emergency visits linked to misuse
or abuse of pharmaceuticals has nearly doubled, and at the same
time emergency room visits for illegal drugs like heroin and
cocaine remained relatively flat.
Furthermore, deaths from prescription drugs are increasing
at a staggering rate, and State data show that seven people in
Florida, four people in Ohio, three people in Kentucky die
every day from an unintentional overdose. The latest national
data found that more than 27,000 Americans died from
unintentional drug overdoses in 2007. Prescription drugs,
particularly the opioid painkillers that were mentioned, are
considered major contributors to the total number of drug
deaths. And in 17 States and the District of Columbia, drug-
induced deaths are now the leading cause of injury death.
And there are two unique reasons for the growth of the
prescription drug abuse: easy accessibility to these drugs and
the perception of risk. For instance, persons age 12 or older
who use pain relievers non-medically in the past year between
2008 and 2009, nearly 70 percent obtained the drug they abused
from a friend or a relative. And research shows that because
prescription drugs are manufactured by reputable pharmaceutical
companies, they are prescribed by licensed clinicians, they are
dispensed by pharmacists, they are perceived as safer to abuse
than illegal drugs, and we know that is not true and we know
that young people aren't buying them in a piece of tinfoil from
behind a gas station.
In addition, recent studies found perceived prescription
drug abuse as safer, less addictive and less risky than using
illegal drugs, and the drugs obtained from the medicine cabinet
or the pharmacy were in their perception not as dangerous as
those drugs that were obtained in other ways.
A comprehensive approach is required to address the
epidemic because prescription drug abuse problems pose unique
challenges. It is important to balance prevention, education
and something close to my heart, enforcement, with the need for
legitimate access to the controlled substances was mentioned.
Therefore, the Administration has created an inclusive plan
which brings together a variety of Federal, State, local, and
tribal groups to reduce prescription drug diversion and abuse,
and while we have outlined our approach to this issue in the
2010 Drug Control Strategy, the Administration developed a
separate plan focused specifically on prescription drugs and
next week Director Leonhart and I along with our Federal
partners will release the Administration's plan. Our
prescription drug abuse prevention plan has four parts:
education, prescription drug monitoring programs, proper
medication disposal and enforcement, and the first part of our
response plan is education. Mandatory prescriber education as
well as patient and parental education is essential.
Second, each State should have a prescription drug
monitoring program. These known as PDMPs are statewide
databases that contain information on dispensed and controlled
substances prescribed by health care providers. PDMPs should be
interoperable and have the ability to share prescriber
information.
The third part of our plan calls for proper medication
disposal. Seventy percent of the people, as I said, reported
getting their painkillers from a friend or relative, and we
need to ensure that proper medication disposal programs are
available, and in September, DEA held their National Take Back
Day and collected over 120 tons.
Let me just close and say that I thank you for your
attention, and I really appreciate the witnesses that will be
coming after me, and my heart as a police chief goes out to
those that have suffered.
[The prepared statement of Mr. Kerlikowske follows:]

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Mrs. Bono Mack. Thank you.
Administrator Leonhart, 5 minutes.

STATEMENT OF MICHELE LEONHART

Ms. Leonhart. Chairman Bono Mack and Ranking Member
Gonzalez, distinguished members of the subcommittee, thank you
for the opportunity to discuss the growing epidemic of
prescription drug abuse and the critical role of the Drug
Enforcement Administration in the enforcement of our Nation's
drugs laws and regulations.
The diversion and abuse of pharmaceutical controlled
substances is a significant and growing problem in the United
States. Every leading indicator shows increases over relatively
short periods of time in the use and abuse of these drugs. Pain
clinics have emerged as a major source of controlled substances
for non-legitimate medical purposes. DEA and other Federal,
State, and local law enforcement agencies have developed great
working relationships and continuously coordinate efforts to
combat this emerging threat. Federal administrative and
criminal actions against a physician with controlled substance
privileges are rare. However, such actions are warranted when a
physician is issuing controlled substance prescriptions for an
illegitimate purpose and operating outside the usual course of
professional practice, and as Administrator, I have made
prescription drug abuse a top priority for the DEA.
I am especially alarmed that another contributing factor to
the increase of prescription drug abuse is the availability of
these drugs in the household. In many cases, prescription drugs
remain in household medicine cabinets well after medication
therapy has been completed, thus providing easy access for non-
medical users for abuse, accidental ingestion or illegal
distribution for profit. The 2010 Partnership Attitude Tracking
Study, PATS, as we call it, noted that 51 percent of those
surveyed believe that most teens get prescription drugs from
their own family's medicine cabinets. DEA manages a robust
regulatory program aimed at preventing and curbing diversion
all the way from manufacturing levels to the dispensing of
these medications to patients, and in working with Congress,
DEA also obtained new authority last year to regulate the
disposal of unused medications by ultimate users, thereby
getting unused medications out of household medicine cabinets
in a lawful and safe manner.
DEA is working diligently to promulgate disposal
regulations, and in the interim, DEA launched a nationwide
take-back initiative in September of last year, resulting in
the collection of 121 tons of unwanted or expired medications,
and I am pleased to announce that DEA is planning a second
nationwide take-back initiative on April 30th, and we will
continue to hold periodic take-back events until regulations
are in place.
DEA's obligation under the law and to the public is to
ensure that pharmaceutical controlled substances are prescribed
and dispensed only for legitimate medical purposes in
accordance with the Controlled Substances Act. By carrying out
this obligation, DEA strives to minimize the diversion of
pharmaceutical controlled substances for abuse while ensuring
that such medications are fully available to patients in
accordance with the sound medical judgments of their
physicians. In this manner, DEA is committed to balancing the
need for diversion control and enforcement with the need for
legitimate access to these drugs.
DEA closely monitors the closed system through
recordkeeping requirements and mandatory reporting at all
levels through the supply chain, and due to enhancements to our
regulatory resources, controlled substance manufacturers,
distributors, importers, exporters and narcotic treatment
programs are receiving more inspections and audits than ever
before.
A key component to our enhanced investigative resources are
tactical diversion squads. These are unique groups that combine
the skills of special agents, diversion investigators,
intelligence analysts and taskforce operators. TDS groups are
dedicated solely towards investigating, disrupting and
dismantling those individuals or organizations involved in
diversion schemes, and as of today, DEA has 37 operational TDS
groups across the country, and we plan to add an additional 26
more over the next few years.
One example of the effectiveness of these tactical
diversion squads is Operation Pill Nation, which targeted rogue
pain clinics in south Florida since February of last year and
culminated in a series of major takedowns in February of this
year. This led to 32 arrests including 12 doctors and five pain
clinic owners. DEA also immediately suspended 63 DEA
registrations and issued orders to show cause on six more,
which resulted in the surrender of 29 DEA registration numbers,
and this caused a ripple effect throughout south Florida and
resulted in 50 more DEA registrations being surrendered, and in
total, we closed down 38 clinics.
DEA recognizes that it can't solve this problem alone. DEA
is working closely with our Federal, state, and local and
private-sector partners as a part of the Administration's
comprehensive approach to combating prescription drug abuse.
Many States have also adopted prescription drug monitoring
programs which are deemed to be a valuable tool in curbing
diversion.
In closing, I want to commend the courage of those who are
testifying later this morning for putting names and faces of
loved ones to this problem, and I want to express my heartfelt
sympathy on behalf of the men and women of DEA for their loss.
I am keenly aware that many others possibly here even today
have struggled with drug abuse by friends and family, and DEA
joins in this fight.
So thank you for the opportunity to appear here today.
[The prepared statement of Ms. Leonhart follows:]

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Mrs. Bono Mack. I thank both of the panelists, and I will
recognize myself for the first 5 minutes of questions, and I
will begin by asking both of you to turn your attention to the
charts on your right. Although the data is old--2007, 2006--
would you both just, yes or no, is it fair to assume that the
trend continues to grow at an alarming rate, that the numbers
today are far worse than they were in 2006 and 2007?
Mr. Kerlikowske. Yes.
Ms. Leonhart. Yes.
Mrs. Bono Mack. Thank you. Administrator Leonhart, you were
specifically talking about Florida. Can you tell me how many
doctors have been convicted or have had their DEA registration
denied or revoked for over-prescribing schedule II prescription
drugs? When Governor Scott points out that 98 of the 100 top
prescribing doctors who prescribe these painkillers that are in
Florida, doesn't that send up a huge warning flag?
Ms. Leonhart. Absolutely, Chairman. The actual numbers of
doctors across the country that have been convicted or
prosecuted, I can get you those numbers, but I can tell you
that you are absolutely correct in that 90 of the top 100 are
in Florida, and Operation Pill Nation identified those top
doctors.
Mrs. Bono Mack. Can you tell me what took so long?
Ms. Leonhart. Well, I can tell you that the trends have
changed. The pill situation, the pill mill situation in Florida
is a really new phenomenon. We first targeted the Internet,
which if you go back 4 and 5 years ago, drugs that we were
finding on the street and we were asking where they came from,
they were coming from the Internet, and it was unregulated,
uncontrolled, and our first efforts were there. It is because
of the Ryan Haight Act that Congress gave us and our actions
going after those organizations and individuals dealing on the
Internet that we were able to basically shut those rogue
Internet sites down, and then we saw the shift over the last
couple of years in Florida. We spent the last year identifying
the pill mills and with a huge operation involving 12 of these
tactical diversion squads over a period of a year were able to
do those undercover buys that resulted in the takedown of Pill
Nation, and we believe that that one consolidated takedown and
actions over the past year will have a chilling effect on
anyone attempting to open up a clinic or to continue in the
same manner that they have continued over the past couple of
years.
Mrs. Bono Mack. I see you have a chart on page 10 of your
testimony that sort of reflects how effective the raids were,
but I have a couple of questions for you just on basic math and
perhaps to both of you. Some people will say that last year we
took back 272 tons of unwanted prescription drugs. Does that
mean we are over-prescribing 272 tons of these prescription
drugs? And if that is the case, can you explain the quota
system to me? It seems to me that there is simple math that you
all are overlooking in a quota system. You both have the
ability to determine how much of these painkillers are
manufactured and pumped out into our society but the quota is
just simply based upon demand? I will turn to both of you.
More specifically, if you look, Florida dispensed more than
41 million oxycodone pills. The second highest prescribing
State dispensed 1 million pills. Large States like California
have dispensed fewer than 400,000. What a disparity. Doesn't
that clearly indicate that there are probably 40 million extra
pills in the supply chain if you look at that mathematical
equation?
Mr. Kerlikowske. Let me mention, I think, two things, and
you bring up an excellent point on the quotas. So one thing is
that the most recent data for all of 2010 for the first time in
8 years shows that the aggregate production of opioid
painkillers actually flattened, so instead of seeing that
incredibly steep increase in abuse and the increase in
manufacturing, we also saw a flattening. I think as we brought
more attention to this, it is going to be coming down.
The other concern would be trying to restrict particular
quotas for particular drugs. We will just turn to a different
drug with a different problem, and it could lead to subsequent
abuse. So I think quotas is one answer and I think that it
needs to be more robustly looked at, and I think those
questions along with our FDA partners are important ones, but I
also think that we are beginning to turn the corner on not only
the aggregate amount of these painkillers that are produced but
also on the registrants who will have to have the mandatory
education, the number of scripts they write.
Ms. Leonhart. And I agree with Director Kerlikowske. A
hundred and twenty-one tons of pills were collected at the
take-back in September. There are a number of reasons, a number
of things we need to look at. Over-prescribing, you brought up
as an issue. I believe that is correct. I believe that it
requires more education for the practitioners who are
prescribing, more education for parents, more education for
young adults and teens who are turning in amazing numbers to
prescription drugs as their drug of choice, and DEA is looking
at the entire spectrum, and we are striking at every level of
the distribution chain, and our problem is that with quotas,
you know, we have a job to make sure that there is enough
medication produced and available for patients in need and we
need to balance that with making sure that people that are not
patients that have a medical reason for these drugs don't get
it. So it is that balancing act, and the problem with quotas is
also that no matter what we do there, there will still be a
legitimate group of people that need that medication and so we
try to get that target number.
Mrs. Bono Mack. Excuse me. My time is expired. I just wish
I would hear you focus more on the people who are dying from
these narcotics and painkillers than worrying about getting
more out there. To me, the problem is 30,000 people a year are
dying.
And with that, I need to yield to Mr. Gonzalez for 5
minutes.
Mr. Gonzalez. Thank you very much, Madam Chair, and again,
thanks to the witnesses. And I understand that once a drug is
manufactured, there are only certain ways it gets out there to
the consumer, and that is going to be--it is on the shelves of
the hospitals or the pharmacist and then there is the
prescription written by the doctor. So I want to talk about
databases.
The first thing that occurs to me is that the most
effective databases, and you have to have the assistance of all
these individuals I just indicated. Those are the points of
origin. So like you are going to deal with any problem, you
have to figure out if you go there first and try to control it
the best you can, then we can deal with the other things that
take the responsibilities of parents and such to make sure that
there is not the availability of those drugs in the medicine
cabinet and so on. And then there are some other issues but I
will discuss it with another panel, and it is going to go to
what the chairwoman was talking about, the amount of
prescription drugs out there and what we can do.
But until we really have, in my opinion, a truly robust and
very effective, widespread adoption of electronic medical
records, health information technology, which is something that
we have been attempting to do since I got here some years ago,
I don't see how effective it is really going to be. Do you have
any concerns about the abilities of all these different
providers or points of origin to be able to access and to
supply information in a manner that is timely and is going to
be available and of course electronically based?
Mr. Kerlikowske. You are absolutely right. I think it is a
shame that when we have to have a chart that goes to the most
recent data of 2006 or 2007. The President's Drug Control
Strategy devoted an entire chapter to the fact that timely,
robust, critical information, whether it is the Drug Abuse
Warning Network, which is number of people brought into the
emergency rooms, whether it is the number of people we test in
only 10 jails in the country for the drug problems of people
coming in to the jail regardless of what they were arrested
for. All of that information is so helpful, and frankly, it is
not timely and it is not as relevant as it should be and
therefore it makes it difficult, I am sure for you in the
policymaking area and it certainly makes it very difficult for
us in that area. So we have devoted this entire chapter to
strengthening these kinds of systems, and I agree with you,
electronic health records will be an important step forward.
Mr. Gonzalez. Administrator Leonhart?
Ms. Leonhart. I agree as well, and last June we started the
e-prescribing. I had signed for that, and it went into effect
in June and we are hoping that e-prescribing helps. I agree
with you completely. And also, we do have 34 States that
currently are using prescription drug monitoring program system
and we see the value in doing that, how having a doctor or a
pharmacist have the ability to look into a system and find out
that someone has been doctor shopping or going from pharmacy to
pharmacy has definitely assisted the States that have enacted
those systems in preventing diversion.
Mr. Gonzalez. And I know that we are always going to have
this conflict. First of all, you have to respect
confidentiality, the relationship of the patient with the
doctor or the pharmacist, the professional and so on. How do we
balance all that? I mean, my fear is that people--one of the
greatest impediments is people don't like the fact that this
kind of information is going to be shared or is going to be
made available. Now, I just believe that if it is made
available to the health care professional and in fact they act
professionally, they are an incredible player or actor in this
whole chain of how these drugs get out there. How do we balance
the confidentiality aspects of it with, as we have said, a
timely and robust database?
Mr. Kerlikowske. The PDMPs, I think the value in them is
that they are designed by the States. So when the States enact
them, they can put in the patient privacy and the
confidentiality rules that they feel are best. They can also
design them as to who has access to them. Some allow at certain
points access by law enforcement agencies. But frankly, the
practice of medicine is governed by the States, the boards of
pharmacy and the medical boards in each of those States having
access to those including routine reports that are generated
from the PDMPs actually put the information in the hands of the
people that have the power to regulate medicine within each
particular State.
Ms. Leonhart. On your next panel, you have Governor Beshear
here, and I know Kentucky is a State that implemented PDMPs,
was very concerned about privacy issues and their systems have
been up and running and have not had problems in that area, and
as we look at the other 33 States that have PDMPs up and
running, they have addressed those privacy issues and that has
not been a deterrent that has worked and that is why nine
additional States have moved and have pending legislation in
their States and are moving towards PDMPs. They have worked
those issues out.
Mr. Gonzalez. Thank you very much. I yield back.
Mrs. Bono Mack. I thank the gentleman. The chair recognizes
Mr. Guthrie for 5 minutes.
Mr. Guthrie. Thank you, Madam Chairman. In the interest of
time, I just want to ask one question and throw it out to both
of you.
I understand that prescription drugs are more accessible to
people in the family. They get them from family members. You
know, a parent may have OxyContin in the house where they
wouldn't hopefully have one that you would typically get on the
street without prescription drugs. But however, what level is
the prescription drug trade also in organized crime, the drug
cartels? You know, is it just doctors over-prescribing or is
there a whole network like you have in other type of drug
issues?
Ms. Leonhart. I can tell you from our enforcement cases,
and we were surprised a few years back, we thought that they
would act, there would be different organizations, they would
act differently because they for the most part are from the
medical profession, they are pharmacists, and actually they are
organized. We learned from Florida, these pill mill
organizations, they are organized just like other organized
crime and other crime groups selling coke and heroin.
Mr. Guthrie. Are they the same groups? Are the cartels
organizing the pill mills or is a different structure, I guess
is my question?
Ms. Leonhart. I will say that they are for the most part
different groups. We don't have a problem with prescription
drugs coming from the Mexican drug cartels, for instance. This
is one of those cases where the sources of supply are not in
Columbia, are not in Mexico. The sources of supply are right
here domestically.
Mr. Kerlikowske. I held a law enforcement roundtable last
month in Buffalo, and one of the enforcement agents talked
about a drug dealer in a particular section of the city in
which heroin was being dealt and then they had a subcomponent
with a dealer dealing prescription drugs across the street.
Mr. Guthrie. Thank you, Madam Chairwoman. I will yield back
in the interest of time.
Mrs. Bono Mack. Will the gentleman just yield for one quick
question?
Mr. Guthrie. Yes, I will yield to the chairwoman.
Mrs. Bono Mack. Just briefly, can you explain how many
people are dying from the illicit drugs any longer as compared
to prescription drugs?
Mr. Kerlikowske. The prescription drug overdose death, that
is driving the numbers that have spiked so significantly. They
cause more deaths than both heroin and cocaine combined.
Mrs. Bono Mack. Thank you, and the gentleman yields back so
the chair recognizes Mr. Towns for 5 minutes.
Mr. Towns. Thank you very much.
Let me begin by--you mentioned the fact that there were 34
States using the monitoring system. Have you been able to
detect that those States that are using the monitoring system,
that the problem is not as severe in those States?
Mr. Kerlikowske. There are two things that I think will be
helpful, and one is that there is a recent evaluation done by
the CDC through a contract, I believe, on prescription drug
monitoring programs. They are relatively new. Some are used
more and some are more robust than others. The other issue will
be, how can they exchange information across State lines. All
of the physicians that I have talked to and all the people that
I have been privileged to be engaged with that have had these
programs find them not only to be helpful in identifying
doctors who may be over-prescribing but patients who may be
doctor shopping, and the doctors themselves talk about it as a
patient safety tool.
Ms. Leonhart. I will say that we are looking at the trends.
Florida is ground zero for prescription drug abuse, and there
is----
Mr. Towns. Do they monitor?
Ms. Leonhart. There is no current PDMP in place in Florida.
As we took action over the last year in Operation Pill Nation,
we are seeing these pill mills actually move and they are
starting to show up in Georgia. Georgia is a State without a
prescription drug monitoring program. So we are concerned. We
believe that States that do enact prescription drug monitoring
programs, that is one of the first things they can do to combat
diversion in their States.
Mr. Towns. Is there any program in place to work with
families that might be taking a certain type of medication that
might be very susceptible to illegal use in terms of a drug, if
it in a cabinet that is locked? Is there any kind of training
program in place?
Mr. Kerlikowske. And I think when you hear later on from
General Dean and the CADCA group, and we fund through our
partner SAMHSA 740 drug-free communities, part of those
coalitions will be, part of their mission is to educate people
about the dangers of the prescription drugs. There are now
locking medicine cabinets that have been made available. There
are pill containers that have locks. But we also think the
important part is bringing this to the attention of people
about what is inside. As the chairman mentioned, when you
collect 121 tons of pills across the country in one 4-hour
period, thanks to the leadership of DEA, that should be in my
old job a clue that we have a problem.
Ms. Leonhart. We have been able to use the take-back
initiative and will on April 30th do the same thing to make it
not only be a way to safely dispose of your expired and unused
medication but also to educate, and I attended one of the sites
on September 25th for the take-back, talked to a number of
people who showed up turning in their prescription drugs, and
to a T they all said they didn't realize they had the
medications stacking up in their medicine cabinet because they
didn't want to flush it, they didn't want to throw it in the
trash in case could someone else could get it, they didn't know
what to do with it. So the beauty of the take-back has been a
way to educate, educate families about how to secure the
medications, and overall having people realize that they don't
need to hold on to that medication and that they have elderly
in the home that could be confused and take the wrong
medication and they have young adults in the home, and that is
the number one source of supply for them.
Mr. Towns. Thank you very much, Madam Chair. I yield back.
Mrs. Bono Mack. I thank the gentleman. The chair recognizes
Mr. McKinley for 5 minutes.
Mr. McKinley. Thank you, Madam Chairman.
I am just curious. In the Appalachian area of this country
that has such a high prevalence of misuse, why is that
occurring? Is that because the medical community is abusing
their prescription authority? I am just trying to get a sense
of why is one area so highly using painkilling medicine?
Mr. Kerlikowske. We just spent 4 days, 3 days in eastern
Kentucky and 1 day in West Virginia, and spent a lot of time
asking people and looking at that including interviewing 14
women who were in the jail system as a result, 13 of them for--
--
Mr. McKinley. Can you speak up just a little bit, please?
Mr. Kerlikowske. Thirteen of them as a result of
prescription drugs, and what we found, particularly in
Appalachia, was that, one, people all know each other and they
sometimes share those drugs that are in their medicine cabinet,
somebody has a back pain and somebody else shares and says here
is something that I found helpful. The other problem came about
as a result of people who had been prescribed a painkiller as a
result of an injury, it could have been even a mining injury,
and then ended up in a problem with that. It is a huge and
significant problem and we couldn't have made the inroads in
understanding it better without the support of Congressional
staff that spent the 4 days with us there just less than 2
months ago.
Ms. Leonhart. And I would like to add that from our
investigations and what we see, just as Kentucky, Ohio,
Tennessee, we saw people that went down to Florida and would go
to these pill mills. We saw that that is a major source of
supply for the pills that are on the streets in West Virginia,
junkets, people that, you know, busloads of people that would
go down to Florida, go to all these pill mills, get as many
pills as they can, return to your area and not only were some
of them addicted themselves but they had multiple----
Mr. McKinley. I am just struggling to understand why
Appalachia. Why not Georgia? Why not Alabama? Why is it the
Appalachia area is singled out for such high drug use, high
painkiller use. I just wonder if the prescribing physicians
are--if it is the prescribing physician. Maybe it is a pill
mill. But what can we do? Because I struggle with it is just a
region. I think it is a national issue.
Mr. Kerlikowske. It is.
Mr. McKinley. Because I think neighbors in New York City
know their neighbors just as well as we do in West Virginia.
Mr. Kerlikowske. And you are absolutely right. As my
travels across the country have clearly shown, the prescription
drug problem affects everyone regardless of race, ethnicity,
gender or economic station in life. In particular, I think it
gets more attention in Appalachia because of the abuse, and we
heard a number of different reasons. I also think that it
doesn't get quite the attention perhaps in some places because
everyone that we met, they are community minded, they know each
other, and there were no secrets. So if you had a friend or a
relative that was suffering as a result of prescription drug
abuse, other folks knew about it. But I think that bringing
attention to it, I think the work that the Congressional staff
has done in both places, West Virginia and Kentucky, will make
a big difference.
Mr. McKinley. Thank you. I yield back my time.
Mrs. Bono Mack. I thank the gentleman. The chair recognizes
Mr. Harper for 5 minutes.
Mr. Harper. Thank you, Madam Chair.
Director Kerlikowske, as you look at this issue, are PDMPs
the only option out there for States to implement the sharing
of this type of information?
Mr. Kerlikowske. Right now for looking at doctors who may
be over-prescribing or patients who may be doctor shopping, the
only systems available are those state-run, statewide PDMPs.
Mr. Harper. Well, are there any State PDMPs that stand out
to you as a role model for other States to follow that you
really are impressed with?
Mr. Kerlikowske. As the Administrator also mentioned, I
think we are both very impressed with what has happened in
Kentucky.
Mr. Harper. With that, I yield back, Madam Chair.
Mrs. Bono Mack. I thank the gentleman, and the chair now
recognizes Ms. Blackburn for 5 minutes.
Mrs. Blackburn. Thank you so much, and I want to thank you
all for being here. Very quickly, just a couple of things.
Listening to you, reading your opening statements,
accessibility is the big problem, it seems, and you are trying
to get into that, part of that, as I mentioned in my questions
to you, looking at both the education components with
individuals' physicians and I think also personal
responsibility and parental participation in this.
Let me talk just a minute with you. Ms. Leonhart, you
mentioned State monitoring systems, the problems in Florida,
the pain clinics as being a problem. In Tennessee, I mean, we
have been talking about over-prescribing by physicians since
the days of Elvis, and, you know, how are you all working with
that? If you are doing State monitoring systems, is there a
method that you are using to incentivize or grant to the
States? What is your position on that and how are you helping
with the local and the State component of that, and if you want
to submit this in writing, because I know we are tight on time,
that is fine. But listening to you, it seems if you going to
say let us get to the crux of this, that getting to that
linkage between your local and State agencies is part of the
crux and dealing with that over-prescribing is another
component.
Ms. Leonhart. We would be glad to submit to you after the
hearing information on specifically what we are doing in
Tennessee and know that the law enforcement officials in
Tennessee have worked with us, are partnered with us to do what
we can to help Tennessee and in many ways they were kind of
ahead of everyone, Tennessee and Kentucky, when it came to use
of the Internet. We learned from Kentucky and Tennessee, for
instance, that there were all these deliveries being made to
people who were ordering substances over the Internet. Working
with them, they helped us develop an Internet strategy. They
are up on the problem. They have worked with us on the problem.
But I will provide additional information.
Mrs. Blackburn. That will be great, and articulate what you
are doing with the grants and the incentive end.
Thank you. Yield back.
Mrs. Bono Mack. I thank the gentlelady. The chair
recognizes Dr. Cassidy for 5 minutes.
Mr. Cassidy. I will also submit a few extra questions for
the record, but in the interest of time, I will limit myself.
Ms. Leonhart, in your testimony you refer to civil
penalties levied against McKesson, CVS, Cardinal. So what is
the role of these intermediaries and what is the role of the
manufacturer in terms of controlling this problem?
Ms. Leonhart. Well, manufacturers and distributors have a
part to play. They have responsibilities, and what we do at DEA
is we make sure that we make them aware of methods of diversion
and ways that their companies, their organizations can do more
to prevent diversion. In these cases, our investigations showed
over and over again that these companies were not doing enough
to prevent diversion. So we used our administrative authorities
working with U.S. Attorney's offices around the country. We
have brought more civil----
Mr. Cassidy. Well, let me ask you, I am sure there is
supply chain control. Are they required to report to you that
Smith's Pharmacy in Dade County is ordering 500 percent more
prescription drugs than you would think normally such a
pharmacy would?
Ms. Leonhart. Yes, they have a responsibility to report
diversion. They have a responsibility to report any suspicious
order.
Mr. Cassidy. Define ``diversion.''
Ms. Leonhart. I am sorry.
Mr. Cassidy. Define ``diversion.''
Ms. Leonhart. Diversion is where the controlled system for
pharmaceuticals is not used, where pills and substances find
their way outside of this closed distribution system. For
instance, thefts, they are to report thefts and losses but they
are also to report pharmacies or rogue pharmacies that are
ordering from them and ordering amounts that changed or
anything that raises a red flag that they are outside of their
normal practices. We have investigated many cases that have
actually started from tips from the companies who have reported
these suspicious orders.
Mr. Cassidy. OK. Thank you very much.
Ms. Leonhart. And those that are not doing it, then we hold
them responsible.
Mr. Cassidy. I yield back.
Mrs. Bono Mack. I thank the gentleman, and the chair
recognizes the gentleman from Washington, Mr. Inslee, for 5
minutes.
Mr. Inslee. Thank you, Madam Chair. Thanks for letting me
join you today.
Chief, thanks for your leadership here. I just wonder if
you can give us an update on the implementation of our drug
take-back legislation, and it is very timely. I just left Lisa
Jackson, the EPA Administrator, and we were talking about
endocrine disruptors in the water system that are changing the
basic physiology of fish and frogs in rather disturbing ways.
So we would like to know how we are doing on this.
Mr. Kerlikowske. Earlier, the remarks were made about truly
what a bipartisan issue this is, and to see the legislation
passed in both Houses and the President sign it and then DEA to
be so involved and having public hearings already to look at
how to restructure the way that pills can be safely disposed of
and not causing environmental damage has been really
heartening. We have had great cooperation from EPA. DEA is
certainly the lead and I am sure the Administrator can mention
that. But we are making good progress, and I think the other
part is the interim steps that DEA has been taking through the
drug take-backs. The next one will be April 30th for your
calendar.
Mr. Inslee. Thank you.
Ms. Leonhart. And I will add that we did hold a hearing a
few months ago. Over 150 witnesses appeared. We took their
information, their comments. We are working that, and we
believe that we will actually have a proposed rule by the end
of the summer. We will publish that proposed rule. That will go
out for a comment period and we will then review all those
comments and move forward with a final rule. But it is on track
and comments have come in. We are reviewing them, and we want
to especially thank you for participating in that.
Mr. Inslee. So what would you describe as your biggest
challenges to make this actually work? You know, law
enforcement is stressed. We have had reductions in the COPS
program, and everybody has budgetary issues. If you were going
to describe challenges that perhaps we could help you with in
any way, what would you say they are?
Ms. Leonhart. Well, making sure that law enforcement has
the tools to combat this at every level of the distribution
chain, but it is also doing what we can. One of your panels has
a number of the community coalitions and the community groups,
the prevention groups. It is making sure that they are getting
the message out and they are getting the support to be able to
do that. It is working with doctors and prescribers and the
medical community. It is what Director Kerlikowske and I will
be announcing next week with this new prescription plan.
Mr. Kerlikowske. Reauthorizing NASPER, removing the barrier
that restricts the Veterans Administration from sharing
prescription drug information, these are all things that
Congress can actually do, requiring mandatory prescriber
education, those things.
Mr. Inslee. Thank you very much.
Mrs. Bono Mack. I thank the gentleman. The chair recognizes
Mr. Kinzinger for 5 minutes.
Mr. Kinzinger. Thank you, Madam Chairwoman.
In the interest of time, I am going to keep this pretty
short. For Ms. Leonhart, I have learned that certain companies
are beginning to do a lot of reformulating of opiates drugs to
make it more difficult for abusers to use and abuse the
product. Do you believe reformulating has been effective in
preventing the abuse of these drugs?
Ms. Leonhart. I appreciate the efforts in trying to
reformulate so that they are not easily abused. However, I am
concerned because we have seen with OxyContin that as soon as
that was put out, we heard that even on the Internet they were
announcing ways that you could go around that. So we are very
concerned but we don't want to discourage industry from
continuing to develop these drugs that can't be easily abused.
Mr. Kinzinger. So have there been for either of you any
discussions about encouraging drug companies and generics to
follow suit or is this something that you personally feel is
ineffective and not really worth pursuing?
Ms. Leonhart. I believe it is worth pursuing.
Mr. Kinzinger. That is pretty much all I have unless you
have something, sir. All right. I will yield back.
Mrs. Bono Mack. I thank the gentleman very much, and I
believe that concludes this panel. I want to thank our
witnesses very, very much for your hard work on this issue,
certainly the boots on the ground who are working this day in
and day out and risking their lives to keep our society safe.
We thank them all very much. Again, appreciate your being here.
The subcommittee will take about a 5-minute recess while we
switch panels.
[Recess.]
Mrs. Bono Mack. The hearing will come back to order,
please. On our second panel today, we have two very
distinguished witnesses who are both deeply involved in the
issues of prescription drug abuse and prescription drug
diversion, which obviously go hand and hand. We are honored to
have Florida Government Rick Scott and Kentucky Governor Steve
Beshear with us today for a perspective on how this battle is
faring in their States.
Without objection, I would like to yield 1 minute each to
Mr. Stearns and to Mr. Guthrie for welcoming remarks. Mr.
Stearns, you are recognized for 1 minute.
Mr. Stearns. Good morning, and thank you, Madam Chair.
I am delighted to introduce my distinguished governor, Rick
Scott, to testify today on prescription drug abuse. He is a
U.S. naval veteran and a lawyer from Southern Methodist where
he received his law degree. He started a business himself and
met a payroll. He actually started Columbia Hospital
Corporation and later became HCA. He has had experience with
small business that he and his wife and family and mother
started to eventually become a large business. He was elected
the governor in November 2010. He is the 45th governor in our
State. He lives in Naples, Florida, with his wife, Ann, of 38
years and they have two lovely daughters, and I am certainly
very proud to introduce Governor Rick Scott.
Thank you, Madam Chair.
Mrs. Bono Mack. And thank you. Mr. Guthrie, you are
recognized for 1 minute to introduce your witness.
Mr. Guthrie. Thank you, Madam Chairman, and my voice is
kind of raspy because Kentucky is in full splendor. Its bloom
is there and it is a beautiful place to be, and I invite people
to come. And in a month, we will have the world watching us,
which we are excited about, with the Kentucky Derby.
But I am pleased to have Governor Beshear here, and I can
speak for the whole delegation on our side that we worked
together on this issue and we will work with our governor on
this issue and make sure we move forward in Kentucky because it
is a big issue. We have a great State, a beautiful State, but
this is a problem that we are exposing here today and we are
working to address.
And Governor Beshear has been involved in Kentucky politics
since being elected president of his UK class, University of
Kentucky, so just a few years ago he got started in politics.
But he has been in the General Assembly, attorney general,
lieutenant governor, and very active in civic life as an
attorney in Lexington, and actually from West Kentucky, but
practiced in the Lexington area. We are really pleased to have
you here. Unfortunately, he got elected in 2007, I got elected
here in 2008, so we only had a year that we worked together in
Frankfort but enjoyed working with you and I am pleased to have
you here today. Thank you.
Mrs. Bono Mack. I thank my colleagues, and also join them
along with the entire subcommittee in welcoming the two of you
today. You will each be recognized for 5 minutes. There are
timers on either side of your table that will reflect green. As
they turn yellow, that means you are, surprise, surprise,
getting close to needing to wrap it up, and when it hits red,
if you could come to a conclusion of your remarks as quickly as
you can, we would appreciate it very much.
So Governor Scott, you are recognized for 5 minutes.

STATEMENTS OF RICK SCOTT, GOVERNOR, STATE OF FLORIDA; AND STEVE
BESHEAR, GOVERNOR, COMMONWEALTH OF KENTUCKY

STATEMENT OF RICK SCOTT

Mr. Scott. Chairman Bono Mack and members of the
subcommittee, thank you for convening this important hearing on
the perils of the illegal distribution of prescription drugs. I
ask that my full testimony be submitted for the record.
During my campaign and since becoming Florida's governor on
January 4th, I have heard firsthand the heart-wrenching stories
from family members and friends of those who have lost their
livelihoods and tragically their loved ones to prescription
drug addiction. So I have been working on solutions to this
problem since being elected. And Chairman Bono Mack, I know you
have been personally touched by this epidemic.
Florida, like much of the Nation, has a long history in the
fight against criminal drug distribution. The names of the
drugs have changed but the problem has remained. Today, one of
the most common names in the fight is oxycodone. Consider some
of the statistics from my State and the scope of the problem
becomes clear. Ninety-eight of the top 100 doctors dispensing
oxycodone nationally are in Florida concentrated around Miami,
Tampa and Orlando. A hundred and twenty-six million pills of
oxycodone are dispensed through Florida pharmacies. By far,
more oxycodone is dispensed in the State of Florida than in the
rest of the Nation combined.
The targets for law enforcement have often been the street
dealers and addicts, essentially the bottom level of the
distribution chain. One tool that focuses on end users is a
database focused on the patient level. This month in Florida,
my Department of Health began implementation of such a
database. While the database moves forward, I am working on
satisfying the privacy concerns of law-abiding concerns. In
2009, the Associated Press reported a massive privacy breach
when hackers broke into Virginia's prescription drug database.
They obtained more than 8.2 million patient records and a total
of nearly 36 million prescriptions. In Florida, I continue
working with my legislative partners to find solution that
protect patient privacy.
More important than computer databases, though, is focus on
the resources of my administration on a law enforcement
solution that starts at the top of the distribution chain
instead of the bottom. Every day, we see that pharmaceutical
manufacturers and wholesalers turned a blind eye when massive
amounts of narcotics stream into the same regions of Florida.
Meanwhile, unscrupulous doctors work with storefront pill mills
masquerading as legitimate health clinics. At each level, there
is an opportunity for law enforcement to intervene and stop the
illegal flow of drugs into our communities.
In these first few months of my administration, I committed
to provide a law enforcement solution, a statewide drug strike
forces. It ensures open channels of communication and multi-
agency cooperation. The goal is clear: target the sources of
these drugs before they hit the streets. It gives our local
sheriffs and police chiefs a statewide coordinated effort that
provides intelligence, analytical and investigative support. As
I speak to you today, local law enforcement strike teams are
working to identify, investigate and apprehend those in the
medical and pharmaceutical distribution chains. I also directed
all the state agencies in Florida to identify investigative
resources, licensing and registration information and
analytical research that can be used by law enforcement.
Florida Attorney General Pam Bondi is working with prosecutors
across our State to ensure these criminals are prosecuted to
the fullest extent of the law. I am grateful to all of these
professionals for their commitment to this important work.
Not only are these efforts focused on Florida, we are also
coordinating with other States to shut down a national
prescription drug pipeline that some have called the Oxy
Express. We are aggressively working to shut down the illegal
supply of prescription drugs from our State both inside and
outside of Florida. Since the beginning of my administration,
there have been more than 50 arrests around the State including
a statewide sweep by law enforcement that raided 15 pill mills
in three south Florida counties.
Just the other day, I was disappointed to learn that a
deputy sheriff in south Florida was the first drug trafficking
arrest made since the initiation of the strike force. It is too
early to go into the details on this and other cases but I can
tell you more investigations are underway and arrests will
continue.
With my partners in the Florida Legislature, we will pass
legislation in the next 3 weeks to prevent doctors from
dispensing narcotics and require doctors to divest of their
pharmacies. Doctors who have forsaken their commitment to
people's health in exchange for the quick buck of unethical and
criminal dispensing must be put to an end. We will also closely
review the activities of wholesalers in Florida and we will put
in place tough penalties for these manufacturers and
distributors who fail to help us turn off the illegal supply
chain.
Let me conclude by telling you that this strategy centered
on a law enforcement solution and targeting the top of the
distribution chain rather than the bottom will make a
difference. I applaud this committee for taking a serious look
at the issue and I want to ask you to also focus your energy at
the sources of this problem. Together, if we hold the
manufacturers, wholesalers, doctors and pharmacies accountable,
we can win this fight. Thank you very much.
[The prepared statement of Mr. Scott follows:]

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Mrs. Bono Mack. Thank you, Governor Scott.
Governor Beshear, you are recognized for 5 minutes.

STATEMENT OF STEVE BESHEAR

Mr. Beshear. Thank you, Madam Chairwoman, members of the
committee. Thank you for allowing us to come here and discuss a
national crisis that has been particularly destructive in
Kentucky and in Appalachia in general, and that is the crisis
of prescription drug abuse.
Let me be frank. Our people in Kentucky are dying. An
average of 82 Kentuckians each month fall victim to drug
overdoses, the majority related to prescription drugs. That is
more than two people a day. To put that in perspective, more
people in Kentucky die from overdoses than from car wrecks.
Greater still is the number of families decimated by the
financial and social toll of this illicit drug use. In the
words of our law enforcement officials, medical professionals
and coroners, what has long been a problem has become an
epidemic.
Our response in Kentucky has been aggressive. We have
ramped up enforcement. We have expanded the availability of
treatment and we have implemented high-tech monitoring and
recordkeeping while working to share that information with
other States. Our prescription drug monitoring program called
KASPER was created more than a decade ago as a tool for both
the medical and law enforcement communities and is now
available electronically. Singled out by the White House in
2006 as a national model, KASPER is inclusive and easily
accessible. Furthermore, in 2005 Kentucky became one of the
first States to require a doctor's examination for the writing
of scripts for powerful painkillers and to require Internet
pharmacies to be licensed in the State. Three years later,
Congress passed the Ryan Haight Act.
But these innovative efforts have not been enough because
as Kentucky has tightened its net, illicit drug users have
found ready supplies of prescription drugs in other States with
looser regulations, and we are not equipped to stop that. What
is needed clear is an aggressive nationwide response, one that
recognizes that this country's prescription drug strategy is
only as strong as the weakest link in the chain.
I am here to push three thoughts. One, I urge Congress to
continue providing resources to the Harold Rogers Prescription
Drug Monitoring Grant Program so that the work toward data
sharing among States can continue. We have come too far with
that program to stop now. Forty-five States have authorized
prescription drug monitoring programs and 34 are currently
operating.
At this point I want to stop and salute the efforts of
Congressman Harold Rogers of Kentucky. He has been a warrior on
this issue of prescription drug abuse.
Secondly, training must be mandated for those who prescribe
controlled substance, especially schedule II narcotics. These
drugs and the risk of addiction and fatal overdoses must be
more clearly understood by both doctors and patients. We can't
leave this education simply to the pharmaceutical sales reps.
And three, the Department of Justice must focus more
attention and resources on Florida, especially south Florida,
to stop the flow of prescription drugs. As Governor Scott and I
have talked, it is a tremendous issue in his State and we both
acknowledge that. Some 60 percent of the prescription drugs
sold and consumed illegally in Kentucky come from the loosely
regulated pain clinics in Florida with each trafficker bringing
back on average more than $10,000 worth of drugs. In 2009,
Kentucky State Police arrested more than 500 people from
eastern Kentucky in its largest drug roundup ever, and every
single suspect had ties to Florida. These pill traffickers are
not amateurs. They are sophisticated. They are well-organized
operations. And the fight against them must be well organized
as well.
I appreciate the very aggressive efforts that Governor
Scott is implementing in Florida to attack this problem. I
appreciate the fact that I believe now they are going ahead to
implement the monitoring system that they passed a year or so
ago.
And that, my friends, is good but it is a start. As we both
know, it is just a start. It is one piece of a much larger
strategy that we have to apply. This is a national problem that
demands national solutions, and the sooner we come together to
recognize that, the greater our success will be. Thank you.
[The prepared statement of Mr. Beshear follows:]

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Mrs. Bono Mack. I thank both our governors and recognize
myself for the first 5 minutes.
I want to thank you both very much. I have encouragement
that the two of you are sitting together, for those in the
audience to recognize this is a bipartisan panel, and if you
were to have only read your written testimony, you would have
thought there would have been some sparks flying, but it seems
that there is definitely a meeting of the minds here and a
recognition first and foremost that the problem exists.
Governor Scott, congratulations on your recent election,
but to you, I am encouraged to hear you are going to move
forward now but I am also hoping you are going to continue to
reject the $1 million that Purdue Pharma offered you. Are you
going to accept or reject that $1 million Purdue Pharma offered
you to fund a database?
Mr. Scott. We are not accepting it.
Mrs. Bono Mack. I thank you for that very much. Can you
speak a little more as a businessman? You saw first and
foremost that the law was being broken and you wanted to come
at it from law enforcement. Can you speak a little bit more
about this approach? Because I would love to see people go to
jail. I would love to see some of these bad actors in handcuffs
being taken off. Can you speak to your efforts a little bit
more thoroughly from the law enforcement side?
Mr. Scott. Well, here is what we can do. We are in
legislative session right now and so we have a very aggressive
bill that is going forward that will help law enforcement, but
in the meantime, we have a strike force. Our Florida Department
of Law Enforcement, we took monies out of that budget right now
and we took a lot of investigators from there, from the
Department of Health and other agencies and provided help to
each of our sheriffs and each of our police chiefs because they
are just overwhelmed with this issue right now. At the State,
we have got a lot more analytical and investigative research
that we can do, so we are helping them deal with that. On top
of that, we have a very aggressive attorney general. Attorney
General Bondi is very aggressive on this issue and so we have
done a good job with arrests so far. Eighty-seven percent of
the oxycodone that comes out of the country comes out of
Florida right now. So the strike force is going to have a big
impact. But I think a bigger impact is going to be the fact
that the doctors will not be able to both prescribe and
dispense, so that will stop that. They are not going to be able
to own the pharmacies. We are going to limit the number of
prescriptions they can do a day. That will have a big impact.
So it is just piece after piece after piece. And then of
course, as we know, they will figure out something and then we
will have to continue to change. But I think all those things
put together with all the data that we are helping our local
law enforcement will have a big impact.
Mrs. Bono Mack. Governor, do you need any help changing
laws up here in Washington that you have found? Are you
changing state law?
Mr. Scott. You know, I think that probably the biggest
thing we need to look at is regulating these manufacturers and
what should these drugs be allowed to be used for. So I think,
you know, the usage of it--I mean, the fact that you can
prescribe for these things, you know, as Governor Beshear said,
some of the things requiring the doctors to have to do a
medical exam and all that, you know, that is already being done
and it is never enough. There is always something else we are
going to have to keep doing. But the first thing is, why are
they even able to sell these things and for what purpose and
should there be a much more limited purpose that these drugs
can be used for.
Mrs. Bono Mack. Well, I look forward to working with you on
these answers and moving forward, and I applaud that you are in
the fight. I also would like to mention Governor Kasich as a
third governor who has become very involved.
Governor Beshear, just a little bit of information. My
parents met and fell in love before World War II at a little
teeny tiny college called Berea, if you know Berea College in
Kentucky. So it is a near and dear place to my heart.
But you also came in here sort of loaded for bear, ready to
set your sights only on Florida, but can you speak a little bit
about what you are hearing the governor say? You are encouraged
about this willingness to cooperate?
Mr. Beshear. Listen, this is not a partisan issue. This is
a life-and-death issue as we all know, and it requires us to
work together. I don't know that there is ever going to be
total solution to this problem. It is always going to be with
us, but we can sure make a significant impact if we work
together and bring all the tools that we have got and cooperate
together. You mentioned Governor Kasich in Ohio. You know, we
are working right now with Ohio trying to figure out how to
share the information between our monitoring systems so that we
can do an even better job than what we are doing.
Mrs. Bono Mack. For the sake of time, one of the biggest
concerns of course is a privacy breach, and we are all very
sensitive to that, and I think nowhere more so than in health
care. Can you speak specifically how you are protecting that
data and consumers can feel confident that they have privacy
that they need?
Mr. Beshear. You know, we have had the system now for 10
years and we have got very strict privacy guidelines. It has a
successful track record. It has never been breached. It is a
felony for folks to breach that system. And it has worked. The
integrity of the system has held together. I don't know of any
system, whether it is with the CIA or the State Department or
the Defense Department or our monitoring system that you can
guarantee will never be breached, that will never find a way
for somebody to hack into it. We obviously will continue to
strengthen with the latest technology those security systems.
But is really a matter of weighing the issues here. You
know, there is a slight risk always whether it is e-health
records or whatever that some breach can occur, but when you
are looking at 82 Kentuckians a month dying, when you are
looking at about seven Floridians a day dying because of drug
overdoses of legal prescription drugs, that is a pretty easy
answer for me.
Mrs. Bono Mack. I thank you very much, and my time is
expired. I recognize Ms. Blackburn for 5 minutes.
Mrs. Blackburn. I want to stay right there with the privacy
and the online database issue because we are the committee of
jurisdiction with telecommunications and the Internet. That is
one of our subcommittees. And the privacy issue is one that we
will do some work on this year. And Governor Beshear, you have
had KASPER for 10 years, and I think it would be helpful to us
as a committee as we consider both the larger privacy debate
and as we look specifically at the prescription drug program to
have some guidance from you all, some suggestions of what you
think we could focus on.
And Governor Scott, let me just continue with the
chairman's question to you. With these databases, what
suggestions do you have and where are you seeing the problems?
Have you all come up with a way to guard against the breaches
and have you had any breaches?
Mr. Scott. Well, we just started to implement ours. When I
came to office, there was a lawsuit that prevented us from
implementing it. So we are just now getting started. And so
what we are doing is, we are looking at what all the different
States are doing with regard to privacy to come up with the
best answer on dealing with that, because it is a big issue and
we have people worried about it.
Mrs. Blackburn. All right. And Governor Beshear, did you
say that you had or had not had a breach on your system?
Mr. Beshear. No, we have never had a breach.
Mrs. Blackburn. You have never had a breach in the 10
years?
Mr. Beshear. Right.
Mrs. Blackburn. So you feel like your firewalls--and do you
do an opt-in or opt-out on information and data share? Get back
to me on that. I know time is----
Mr. Beshear. I will. I am not sure on that.
Mrs. Blackburn. OK. Let us talk about education just a
second because this is something with the prior panel as we had
the DEA before us that we looked on just a little bit, and I
think that it is important for us to continue to move forward
with education. I would like for you each to give me just a 1-
minute response on what you are doing with public education,
with personal responsibility education, with parental
education. I know in Florida the pain clinics are a problem
that was recently discussed, and then you have a little bit of
history, Governor Beshear, so if you all would talk about the
education component, that would be helpful. Governor Scott
first.
Mr. Scott. Sure. Well, what we are doing is, first off is
making sure the public knows just through articles and things
like that, make sure the public knows how big the problem is. I
have done press conferences and things like that. I have
brought it up through--we have had testimony in the legislature
to talk about the issue. We spent a lot of time this
legislative session going through what the problems are. So
that is the biggest thing we are doing right now.
Mr. Beshear. Certainly the public education part of it in
terms of talking about it publicly, and it is talked about a
lot publicly in Kentucky right now, and I am glad of it because
at least it is exposing all of our citizens to this dreaded
problem. Also in our pharmacy schools, in our medical schools,
we are pushing to make sure that our doctors really understand,
the ones that are coming out, and the pharmacists understand
what they are really doing and that they don't get their
information just from the drug reps, that they have the kind of
information they need to handle these kinds of drugs very
carefully and very effectively.
Mrs. Blackburn. Do you think most Kentuckians realize you
have the KASPER system in place?
Mr. Beshear. I think there is probably a general knowledge
we do, although it is probably not understood in terms of what
it really does. But we are looking at strengthening that
system. Right now, you know, doctors can voluntarily be in it
or not be in it. I am thinking of beginning discussions about
making that a little stronger.
Mrs. Blackburn. Having it be mandatory?
Mr. Beshear. Making that a little stronger. You know, I
think doctors ought to be in that program.
Mrs. Blackburn. Thank you both, and I yield back in the
interest of time.
Mrs. Bono Mack. I thank the gentlelady. The chair
recognizes Mr. Stearns for 5 minutes.
Mr. Stearns. Thank you, Madam Chair.
Governor Beshear, when you mentioned that more people are
dying from overdose than automobile accidents, that is
appalling. That is just a frightening statistic.
Governor Scott, earlier we had a Florida delegation, Madam
Chair, so I heard some of the testimony from the governor, and
I guess the question that came up when we had the delegation
meeting, can pain clinics be subject to additional scrutiny
before they are licensed to practice? Is that a place where we
could start?
Mr. Scott. We are doing that now. We are doing it through--
we already have where they have to be licensed so we are doing
that. But it is not perfect. It is not easy to get around, but
you can get around it. So that is actually one of the things
that is in our bill. But the big thing is, think about this. We
know the manufacturer, we know the distributor, we know the
doctors that are distributing it. We ought to be able to stop
this if we just keep tracking it. Now, people will change and
there will be a new drug or something like that but this is a
legal distribution system that is doing it the wrong way so we
ought to be able to--if we track it all the way and have
criminal penalties and civil penalties for everybody that is
doing the wrong thing, I think we will have a dramatic impact
in Florida for a period of time and then something will change.
Mr. Stearns. Governor Beshear, anything you want to add to
that?
Mr. Beshear. No. I think we need to be as aggressive as
possible in all of these areas. We need to be aggressive in
regulation of all of these folks and regulation of what the
pharmaceutical companies can do in terms of who gets these
drugs and how they are dispensed. We need to be very aggressive
in the law enforcement area. And I think what Governor Scott is
doing in Florida is showing that kind of commitment very
quickly, and we have been doing that in Kentucky for some time
also.
Mr. Stearns. Intuitively, the relationship between the
doctors and the pharmacies, is that anything that you as a
governor, either one of you can do in terms of educating or
threatening or somehow trying to influence the relationship
between the pharmacy and the doctor, or is that sort of
sacrosanct, that there is nothing you can do?
Mr. Scott. We are doing it in our bill. The doctor that
prescribes will not be able to own a pharmacy.
Mr. Stearns. Oh, that is good.
Mr. Scott. So we are going to completely separate it, and
then we will have the data. We will be able to track all the
way through. But I think stopping the ownership will have a
significant impact.
Mr. Stearns. Is there any State that has in place some of
the things you have already talked about, Governor?
Mr. Scott. I haven't seen anybody that restricted the
ownership of pharmacies.
Mr. Stearns. Yes?
Mr. Beshear. One of the other things, and I am not sure how
his laws are set up, but I appoint the doctors to the board of
medical licensure and the pharmacists to the pharmacy
regulatory board, and I have made it a very clear point before
I appoint anybody, I have them come in and we talk about these
kinds of issues, and I get a commitment from these folks to
really bore in and try to address these kinds of issues as much
as possible, and I think that is just another tool that we have
to attack this problem.
Mr. Stearns. Now, is there anything that the Federal
Government, either one of you think we as legislators on the
Federal side or perhaps direct the Federal agencies in some way
that could make your job easier so we can stop these drugs from
coming down the pipeline? So any suggestions you have would be
very helpful. Governor Scott?
Mr. Scott. Sure. I think the biggest thing is, why--I mean,
there ought to be restrictions on how these drugs can be used
and what they can be prescribed for.
Mr. Stearns. From the Federal level?
Mr. Scott. Yes.
Mr. Stearns. From the FDA?
Mr. Scott. Right.
Mr. Stearns. OK.
Mr. Beshear. Another area that I hope you all will pay
particular attention to are continued funding for the Hal
Rogers Act that is on the books now. That will help the States
to share information and develop the systems to share
information, and that will be effective in this battle, the
HIDA, the Erns Jag awards and grants that are made that help us
fight this specific problem. I know that just as Governor Scott
and I are fighting budget battles every day, you all are too,
but some things are more important than others and that is the
way we all have to look at the way we balance our budget. That
is what I do. That is what he does. And I just ask you in that
priority, put this priority up there.
Mr. Stearns. Well, I want to thank you. My time is expired.
But I think the fact that both of you governors took the time
to come up here to talk about this serious problem, I think is
a commendation to you and also for us having this hearing,
Madam Chairman, because this shows that even though we are
trying to reduce spending up here, this is a priority, I think,
that is very serious in this country, and we have ways to stop
it. So thank you for your testimony.
Mrs. Bono Mack. Thank you, Mr. Stearns. Mr. Guthrie, you
are recognized for 5 minutes.
Mr. Guthrie. Thank you very much, Madam Chairwoman. And
also your roots are from Muhlenberg County, or several
generations back, I believe.
Mrs. Bono Mack. That is right.
Mr. Guthrie. Which is near where the governor is from, a
couple counties over from where the governor is from. So thanks
so much. And I did mention the first lady, she is from my area,
so I should have mentioned that in the introduction. So I
appreciate what she is doing as well for our State.
When we did KASPER, I remember it coming forth, and I will
tell you, there is not a legislative session that doesn't go
on, particularly the legislators from Appalachia, have always
pushed what can we do to improve monitoring, interdiction. So
the Kentucky leadership is focused on this and trying to help
solve this problem.
If I remember some of the participation in the Medicaid,
because it seems that the prescription drug problem is in areas
that are heavily Medicaid as well, and I don't know if you know
the correlation between that or if you have seen as well,
Governor.
Mr. Beshear. Certainly, you know, prescription drugs are
allowed under the Medicaid program obviously and every State is
involved in that program, and you are going to have some abuse
within that program, and we are very aggressive in the Medicaid
area of trying to weed that out and at the same time educate
people. You know, we are pushing in the Medicaid program the
ability of our local health departments and those regional
medical centers to educate our folks about the dangers of these
narcotics. You know, so many of these people that end up being
addicts start out as legitimate drug users, you know, that they
need something for their pain or this or that, and they start
out in a very legitimate way and then they end up being
addicted and then they get into this cycle of buying the drugs
illegally, and that just grows the problem.
Mr. Guthrie. And I know you weren't governor at the time,
but when we passed KASPER, I don't remember Florida being such
a big issue for us 10 years ago, but KASPER, did it just move--
because I-75, wonderful highway, we love I-75 and people go to
Florida and enjoy it and love it, but it also seems to be a
pathway for the prescription drugs to come to Kentucky. Is that
because we had KASPER because it helped curtail some of the
problems we had so it just has moved?
Mr. Beshear. Sure. You know, before we had KASPER, they
would just stay in Kentucky and get these drugs illegally, and
we haven't cut all of that out. I don't want to even imply
that. But we made a significant impact in it by having this
monitoring system among several tools that we have, and the
fact is, no State is an island, you know. Folks, if we stop
them doing something in Kentucky but they can do it across the
State line, they will go do it across the State line. And that
is why it is so important for all of us all across this country
to find ways to address this. It doesn't have to be uniform
everywhere but it has to be everywhere for this to really work.
Mr. Guthrie. Well, thanks. And I think I saw you on the
news a couple of weeks ago. I know Florida is in session, and I
guess a bill had seemed to have failed in Florida that might
have addressed this, but it sounds like Florida does have a
bill moving forward in the legislature now. I don't know if it
stalled or whatever. I am glad to see you all together working
on this because it is a problem for all of us. But what is
going on in the Florida legislature to address the tracking or
the similar KASPER deal?
Mr. Scott. Well, first off, the monitoring bill was passed
last year, and there was a lawsuit that just got finished last
Friday.
Mr. Guthrie. Maybe that is what you were referring to.
Mr. Scott. So that has finished. But we have a very good
bill that looks like it is going to get out of both the house
and the senate, which everybody has signed off on including the
attorney general, who is very focused on this, and if you
prescribe the drug, you can't dispense it out of your office.
You can't own part of a pharmacy. There is a restriction on the
number of prescriptions you can do a day. We have got tamper-
resistant pads to write the prescriptions. We have got
licensing of the pill mills and we have got criminal penalties,
civil penalties going all the way up to the manufacturer. We
are going to try to do everything we can to stop it. It is a
big issue when 98 of the top 100 doctors in the country
prescribing oxycodone are in Florida.
Mr. Guthrie. So are Florida's laws different? Because I-75,
you have to go through Tennessee and Georgia to get to Florida.
Are you all just so different? I know you are working on that?
But is it so different now, the current status than Georgia or
Tennessee? I mean, Kentuckians aren't going to Tennessee, they
are going to Florida, so what is the difference, I guess?
Mr. Scott. Every State has been different.
Mr. Beshear. And what has happened is that some of this is
starting to move to Georgia because Georgia doesn't have a
monitoring system. Tennessee does. And that is, I think,
initially what pushed it south, and you know, Georgia may be
the next place that we really have to push hard to get them to
address this situation.
Mr. Guthrie. Thanks, Governors. Thanks for making the trip
to Washington today. I appreciate it. I have to yield back now.
I am out of time.
Mrs. Bono Mack. I thank the gentleman. Mr. Harper, you are
recognized for 5 minutes.
Mr. Harper. Thank you, Madam Chair, and welcome to each of
you, and it is an honor to have you here. This is a very
important issue. We all have friends who have had their
families devastated, primarily by young people who get those
prescription drugs from their medicine cabinet at home. That
seems to be a major problem.
So how do we solve the underlying problem here is that no
matter what regulations we put on, which will be very helpful,
how do we convince these young people not to use the drugs, not
to take them? Are you doing anything in conjunction with, say,
success in drug courts or any faith-based programs? Governor
Beshear, I will ask you that first.
Mr. Beshear. Yes, we have drug courts, we have faith-based
initiatives that all work in this area. Obviously a part of it
is education, and we are pushing that both in the public school
system as well as through faith-based initiatives. The other
end of it is treatment and rehabilitation, and we took a
significant step recently in Kentucky by revising a major part
of our corrections system and our approach to corrections to
put a lot of time and effort into treatment and rehabilitation
so that we can stop recidivism and stop that revolving door to
where folks just get out, you don't give them any help, you
just turn them loose again, and, you know, within 30 days, they
are out trying to buy the drugs again and they are back in. And
we brought the Pew Foundation into Kentucky and had a
bipartisan effort of Republicans and Democrats, our house, our
senate, our supreme court, the court system as well as the
governor all got together, and we have made some major changes
that I think on that end of the spectrum will address the
recidivism rate.
Mr. Harper. And Governor Scott, your State dealing with
drug courts or faith-based initiatives to help in this effort,
what is the story there?
Mr. Scott. Well, the big thing we are doing since I have
been in office is educate the public to make sure everybody
gets on board, first off, making sure we get this legislation
passed so that was very important to get that done. The strike
force is very important. On top of that, just continuing to
educate the public. The schools are educating the public. Also,
the individual I put in charge of Department of Corrections is
very focused on this and the same thing as Kentucky, very
focused on the number of people that get out of prison and go
right back and have the same problem. So he is somebody that is
very focused on that issue.
Mr. Harper. Well, obviously our goal is to make sure they
never get into the court system in the first place and how do
we encourage folks this is not the route to go?
Mr. Scott. Well, one thing we have done is, our juvenile
justice is run by an individual from Miami. She came up to work
with me, and she is focused on a program that she has worked
for 20 years in Miami that has had a dramatic impact in
stopping sort of the--the first time you get stopped for
something, you don't end up in prison just because it ends up
being a cycle. So all the things she has done starting with
civil citations and starting with, if you get stopped for the
first time, it is not just that issue. You might have an issue
over food, shelter, family issues, things like that, and having
a holistic approach to it to stop them from ultimately ending
up in prison. So we are taking all the things that she is doing
and spreading them across the State. On top of that, we have
legislation that would allow us to do a civil citation program
rather than immediately moving into a criminal program.
Mr. Harper. And how you secure the prescriptions at
someone's home so that no one other than the intended patient
gets it is a really tough thing to do.
Mr. Scott. That is the hardest.
Mr. Harper. I am interested in what you said about your
task force that you have in place. How are you going to measure
the success of the mission of that task force? What are you
anticipating or hoping for out of that?
Mr. Scott. Well, the numbers have to get better. We can't
have 98 of the top 100 doctors, 126 million pills. It is
basically, how do we stop basically all this happening in our
State. But it is going to be arrests, it is going to be the
number of prescriptions that are done. In the end, it is
prescriptions and deaths.
Mr. Harper. What about working in conjunction with your
State medical association? What input have they given either of
you?
Mr. Scott. Well, in our case, they are very focused. I am
doing something similar because I have the opportunity to
appoint the members of the board of medicine, so as I am going
through that process and talking to individuals about those
positions, I have talked to them about how important this issue
is and the fact that they have got to be engaged and the board
of medicine has to be engaged.
Mr. Harper. Governor Beshear?
Mr. Beshear. Same thing here. You know, we are engaging the
medical profession, the pharmacy profession as well as their
regulatory boards, and you know, as I am sure Governor Scott
would point out, those boards, their first duty is to protect
the public and not just protect themselves, and we see a little
bit of that in every regulatory environment whether that is
lawyers, doctors, pharmacists, and I am a lawyer so I can say
that about myself. But, you know, we have got to emphasize that
their first duty is to the public and to protect the public,
and it just comes down to appointing the right people.
Mr. Harper. Thank you each for being here, and Madam Chair,
I yield back.
Mrs. Bono Mack. I thank the gentleman. The chair recognizes
Dr. Cassidy for 5 minutes.
Mr. Cassidy. Thank you for being here, gentlemen. My pain
doctors really like the PDMPs because they feel like the pill
mills give everybody else a bad name. Now, that said, I gather
from testimony that some of these PDMPs are robust and some of
them are limited in ability.
Now, Governor Scott, clearly you have legitimate concerns
regarding the privacy, but as much as you can say, and I gather
Kentucky has a rather robust program, where do you imagine
yours will be on the spectrum? And I just mention that because
at the previous meeting, Florida was described as ground zero
for the promulgation, if you will, or the source, if you will,
for these drugs across the Nation.
Mr. Scott. Well, it is clearly ground zero, so it is a
significant issue and things that are--Florida's problem is a
problem for the whole country because we haven't stopped the
abuse. So our database will be--what we are doing is, being one
of the later States to do it, we will be able to take all the
benefits, take all the knowledge from the other States, which
is what we are doing, both to make sure we have the right
information and also have the right privacy concerns that we
can address, so we will be doing both of those. But on top of
that, we are going to make sure we are tracking from the
manufacturer to the wholesaler to the doctor, not just at the
pharmacy after the fact, because after the fact is going to be
part of what we do but I think the biggest part is going to be,
we are going to stop the distribution of it.
Mr. Cassidy. I see that. OK. Now, let me ask you, my pain
doctors also tell me part of the problem is that someone may
live on the Pearl River borders between Louisiana and
Mississippi, and I think there is a Pearl, Mississippi, and a
Pearl, Louisiana, and they say live in one State and go to the
other and they will get as much they can below the threshold
here and then they will go back here, and they will do as well
on the other side. Now, clearly, that just may require a
Federal overlay, but as two fellows who obviously will be
jealous and respective of States' prerogatives, how do we keep
folks from popping across State borders to maximize--do you see
where I am going with that, Governor Beshear?
Mr. Beshear. Well, first of all, both States need the
monitoring program, and do both of them have that?
Mr. Cassidy. They both do, but each is self-contained.
Mr. Beshear. Right, and they need to be doing what we are
doing with Ohio right now. We are sitting down and trying to
work out how to share information, and we are going to do that.
Governor Kasich and I will end up--we will find a way to do
that. And we are being helped by this Hal Rogers grant program.
That is the money that has been provided to help States work to
share information in these monitoring systems, and we need to
continue that. We need that funding to continue doing this so
that every State ultimately will be sharing across State lines.
That is the only ultimate way that these programs will be as
effective as possible.
Mr. Cassidy. And so although you start off with Ohio, you
share a border, you actually envision that eventually you may
partner with Governor Scott, for example?
Mr. Beshear. Yes.
Mr. Cassidy. And wherever there is a potential
distribution, to be able to go there?
Mr. Beshear. Yes. We all need to partner eventually so that
there is no place in this Nation that people can go and be able
to do what they are doing now as freely as they do it.
Mr. Cassidy. Now, Governor Scott, I have to admit, I am a
gastroenterologist, which I tell people prepared me very well
for Washington, D.C. So if what I am about to ask you seems
very simplistic, it may be, but it seems like if you know who
those 98 docs are, all you need to do is have an undercover
person walk in. I am told these pill mills, you may $250 or
something for a visit. Five minutes later, you walk out with a
handful of prescriptions. It seems like you could go to each of
these and put them out of business for inappropriate
prescribing. Why not?
Mr. Scott. The difficulty is that the smart ones, what they
are doing is, it will appear legitimate. They will do the MRI,
they will do the history, they will do all these things, and so
it is not as easy as just walking in and saying that you are
doing something wrong. You have to have--that is why we spent a
lot of time on this legislation with the attorney general and
with the sheriffs and the police chiefs to make sure that what
we are passing is something they are going to be to convict
with because they will do all the--everything I have been told,
they will do all the basic things to make sure it is very
difficult to stop them.
Mr. Stearns. Will the gentleman yield just for one second?
Mr. Cassidy. I will.
Mr. Stearns. I would think if you just let out the word
that you are going to do sting operations, I mean, I would
think that would create a pale over those physicians that might
retard them from doing this. So I know, Governor Scott, it
sounds difficult but I think what the gentleman is saying is,
the fact that these stings might or might not come would create
some caution.
Mr. Scott. I think the difficulty is, there is a lot of
money in this. There is a lot of money being made.
Mrs. Bono Mack. I thank the gentleman. We are fortunate to
have the governors, I understand, until 10:15, so we would like
to do a second round of questions until that point if my
colleagues are so inclined, and I will recognize myself for the
first 5 minutes and just point out a few things that I think
are essential for this discussion.
First and foremost, it was my understanding that OxyContin
was originally approved for severe cancer, late stages of
cancer for severe pain yet the number-one prescriber today of
OxyContin to children 12 and over is dentists, and I think that
should be pointed out.
I would also like to talk a little bit about the parental
education, words that keep coming up, and point out that we
have two panels yet to speak who will show that parents of all
walks of life are affected by this and that it is impossible to
detect this problem until it is too late.
Governors, in your travels and your meetings with addicts
and loved ones of addicts, first of all, would you be--I
contend that OxyContin is heroin. Would you take big umbrage
with that? Would you say that is about right, what you are
seeing?
Mr. Scott. You know, you never know the definition, but I
can tell you, we ought to really restrict what it can be
prescribed for.
Mrs. Bono Mack. I have a bill that does just that, and I
will be looking forward to working with you on that. You keep
speaking also, Governor, about limiting all of these leftover
pills in the medicine chest, and I keep wondering why we are
prescribing, you know, hundreds of tons of pills a year that go
unused. If patients don't want them, why are they getting out
there? That is another question that I look forward to
exploring with you.
And Governor Scott, I want to applaud you on your decision
to reject the $1 million from Purdue Pharma for your database.
Just recently there was an article here that points out that
the CDC authored a study where they linked these powerful
painkillers to deaths and the University of Wisconsin School of
Medicine released a study that disputed that and talked about
liberalizing opioids, and lo and behold, financed by Purdue
Pharma, and I would like to submit this article for the record.
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Mrs. Bono Mack. And I think people need to start looking at
the connection between these studies and these policies and the
big money that you were just speaking about, Governor Scott.
Governor Beshear, clarification again if I might. You did
say the number of fatalities in Kentucky from drug overdoses
has now surpassed automobile accidents. Is that legal or
illegal drugs, again?
Mr. Beshear. It is a combination but the majority of it is
legal drugs, abuse of legal drugs.
Mrs. Bono Mack. Thank you. And then Governor Scott, as a
businessman, when you look at the chart for the dramatic
increase of opioid abuse, it is ironic that the trend line
started screaming upward shortly after OxyContin was approved.
As a businessman, does that look kind of fishy to you like it
does to me?
Mr. Scott. Yes.
Mrs. Bono Mack. Thank you.
Mr. Scott. If you look at my testimony, you see how many--I
mean, 87 percent of it coming out of Florida too and just the
dramatic increase.
Mrs. Bono Mack. Thank you. And another point, as somebody
who has spoken publicly about my family's problem with this or
being involved with this disease of addiction--and it is a
disease and I am happy that Congressman Harper brought up that
side, that they shouldn't be necessarily in the courts but we
should treat it as a disease first and foremost. But as
governors, when you meet the families that are suffering,
aren't these just normal families, regular families? I can show
you stacks and stacks, I know you have pictures too, of kids
who are in their senior year of high school, one family whose
son died just a week before his graduation from high school,
and he was an all-star athlete, on the dean's list. Everything
is right about these kids. Do you believe like I do that when
these kids get access to these powerful painkillers they don't
stand a prayer in the ability to stay off of them?
Mr. Beshear. This cuts across income brackets, it cuts
across every bracket. This is a problem that everybody is
having, and I don't know that there is anyone in my State or
any other State anymore that doesn't know somebody, whether it
is in their own family or a friend or another family that has
been affected by this.
Mr. Scott. Yes. A good friend of mine's 18-year-old just
died 2 weeks ago of an overdose, and he found her. It would be
horrible. But it impacts everybody.
Mrs. Bono Mack. Was your friend aware that his daughter was
using?
Mr. Scott. He had found out, sent her to a program. What
happens to a lot of people is that, you know, the kids turn 18,
they don't have to be in a problem.
Mrs. Bono Mack. There is a mother who will speak to that on
the next panel, to that very thing.
Have either one of you ever met somebody who wanted to be
addicted?
Mr. Scott. No. I have a family member that has been
addicted his whole life, never beat it. He started at a young
age and never beat.
Mrs. Bono Mack. And it is a lifelong struggle. Again, I
thank you two very much. I look forward to our continued
working relationship. Again, I appreciate your courage in being
here today.
I will now yield to Ms. Blackburn for 5 minutes.
Mrs. Blackburn. Just a follow-on. Governor Beshear, you
mentioned you were thinking about putting your program as a
mandate, and as I have sat here listening to you all respond to
the questions, I am thinking, you know, it must be very
difficult, and you may have some guidance for having a program
that is an opt-in for your pharmacists and your physicians, and
it seems as if those who are illegally prescribing or
illegitimately prescribing, over-prescribing, would choose not
to use the system. So I wonder what--if you would just explain
a little bit about what has led you to that, and as Governor
Scott is setting his program up, what would you advise him?
Would you advise him for it to be a mandate from the get-go?
Mr. Beshear. Well, I am going to be sitting down with our
medical licensure board and our medical association and the
dentists and the pharmacists and talk about this, but so far it
has proven effective the way it is set up in that the doctors
that are using it can actually detect other doctors even if
they are not using it that are over-prescribing and are abusing
the system as well as being able to detect those who----
Mrs. Blackburn. So you are using it as an accountability
tool even for those that are outside of the system?
Mr. Beshear. Yes.
Mrs. Blackburn. OK. That is great. Now, how do you pay for
your system and what is the cost of it each year?
Mr. Beshear. It is paid for by State funds.
Mrs. Blackburn. Taxpayer dollars?
Mr. Beshear. Taxpayer dollars, and I am not sure, I can't
tell you offhand what it costs.
Mrs. Blackburn. If you would submit that?
Mr. Beshear. It costs a fraction of what it costs to handle
the problem the other way.
Mrs. Blackburn. All right. And Governor Scott, you said you
are not taking a grant that was offered to you so how do you
all intend to pay for your system?
Mr. Scott. We have funding from other individuals and
companies that are putting the money up.
Mrs. Blackburn. Are they pharmaceutical companies or----
Mr. Scott. No. We have got 2 years of funding right now. We
are just starting to implement ours.
Mrs. Blackburn. Correct.
Mr. Scott. But no, it is not pharmaceutical companies.
Mrs. Blackburn. So it is private funding?
Mr. Scott. Right.
Mrs. Blackburn. So there is no taxpayer dollar involved?
Mr. Scott. No.
Mrs. Blackburn. OK. Thank you. I yield back.
Mrs. Bono Mack. The chair recognizes Mr. Guthrie for 5
minutes.
Mr. Guthrie. Thank you, Madam Chairwoman.
Again, I think that if I remember the problem, we were
trying to define it in the legislature, it seemed to be
Medicaid, you know, where if you have private insurance and
they limit how many prescriptions you can get over and over,
and we had to address that with the Medicaid but it just seemed
that is where a lot of the prescriptions were coming, not
everyone. It cuts across all swaths of people. But the
concentration of it was. And you weren't here, Governor
Beshear, earlier but Mr. McKinley asked the question to the
panel before, to the DEA, about why does Appalachia seem to be
in a bigger--you know, because it is not only Appalachia using
drugs in Kentucky, I can tell you that. In my area, though, it
is methamphetamine. So every time we would show up in Frankfort
for our legislative sessions, groups of us were trying to fight
meth and other groups were fighting this. But it does seem the
prescription drug part of it is concentrated in Appalachia
where in my area it is the illegal manufacture of meth. I don't
know the answer to that, and I thought it was a good question.
I don't know if you all have looked at that way, why Appalachia
seems to be more on the prescription side. Maybe it is I-75
access to Florida versus our area is not that way. I don't
know.
Mr. Beshear. Well, it is obviously a nationwide problem.
There are, I think, concentrations of prescription drug abuse
in some places. There are concentrations of things like meth--
--
Mr. Guthrie. In my area.
Mr. Beshear [continuing]. And illegal drugs in other
places, but obviously it blankets the United States and it is
getting worse, not better.
Mr. Guthrie. You know, when we come to Washington and talk
about problems in our State, we have to do that, but obviously
we have--and you are the governor of my favorite State and
obviously a beautiful place, but we have to talk about these
problems and we have to get together and try to solve them. So
thank you very much for being here today.
Mr. Beshear. Well, the first step is to recognize that we
have got the problem.
Mr. Guthrie. I think Governor Scott wants to comment.
Mr. Scott. Somebody just told me that there are no State
taxpayer dollars but we are going to get some dollars from the
Hal Rogers Federal grant, but there is no State taxpayer
dollars.
Mrs. Bono Mack. Thank you for the clarification.
Mr. Guthrie. If you want my time, Madam Chairwoman, I will
yield you my time back.
Mrs. Bono Mack. Oh, thank you. I was taking it anyway.
Mr. Guthrie. OK. Go ahead.
Mrs. Bono Mack. I think an important issue is whether or
not there was other pharmaceutical money involved, which is a
question we debate here on many things, but in this specific
instance, I thought the Purdue Pharma, your decision on that
was a good one, and I applaud both of you to wrap it up and to
thank you for your time today and your spirit and the
willingness to truly address this problem. We are not going to
end it. We are not going to solve it entirely. But I do believe
good, innocent people are suffering, and crime, it is a very
basic situation for me. The FDA approves and regulates and the
DEA is supposed to control, and with statistics like that, it
shows that we are failing, and it is time to stop. Too many
people are dying and too many of our constituents, and more and
more of my colleagues would have participated today. I know
Congressman Vern Buchanan is very interested now, Congressmen
from Massachusetts are very interested. This is not only
Kentucky and Florida, it is nationwide, and as the panels go
on, we will focus on California and what is happening. So
Florida, don't feel that it is all you because it is throughout
the country.
But thank you, gentlemen, very much. I look forward to
working with you.
At this point the subcommittee will take a very brief
recess to seat the third panel.
[Recess.]
Mrs. Bono Mack. The subcommittee will come back to order,
please. I thank the staff for being so quick in switching the
panels over.
On our third panel, as you can see, we have seven witnesses
as I introduce them all at once. First is Phil Bauer, surviving
father of Mark Bauer. Phil serves on the Parent Advisory Board
for the Partnership for a Drug-Free America. Our next witnesses
are Kathy and Courtney Creedon, surviving mother and sister of
Ryan Creedon. Kathy is also Founder of Mothers against
Prescription Drug Abuse, and I am blessed and lucky enough to
call them my own constituents. Also testifying will be April
Rovero, surviving mother of Joey Rovero and Founder of the
National Coalition against Prescription Drug Abuse. Our next
panelist is Dan Harris, who overcame a prescription drug
addiction to gain custody of his children. He is a drug court
graduate and also a constituent of mine. And finally, we are
pleased to have Dr. Carol Boyd and Dr. Amelia Arria, who are
widely respected nationally for their insight into addiction.
On a personal note, staff told me to say what I already said
about how proud I am to have some constituents on this panel.
So welcome to each and every one of you. I really
appreciate your being here. If you can see the timer boxes down
there, it is just like a traffic light, green, yellow and red.
You know what they mean. The total time you are allotted will
be 5 minutes each, so we are now going to recognize Phil Bauer
for 5 minutes.

STATEMENTS OF PHIL BAUER, FATHER OF MARK BAUER AND PARENTS
ADVISORY BOARD MEMBER, PARTNERSHIP AT DRUGFREE.ORG; KATHY
CREEDON, MOTHER OF RYAN CREEDON AND FOUNDER, MOTHERS AGAINST
PRESCRIPTION DRUG ABUSE, ACCOMPANIED BY COURTNEY CREEDON,
SISTER OF RYAN CREEDON; APRIL ROVERO, MOTHER OF JOEY ROVERO AND
FOUNDER, NATIONAL COALITION AGAINST PRESCRIPTION DRUG ABUSE,
AND PARENT AMBASSADOR, PARTNERSHIP AT DRUGFREE.ORG; DAN
HARRISON, DRUG COURT GRADUATE; CAROL J. BOYD, PH.D., R.N.,
F.A.A.N, DIRECTOR, INSTITUTE FOR RESEARCH ON WOMEN AND GENDER,
PROFESSOR OF NURSING, UNIVERSITY OF MICHIGAN, ANN ARBOR; AND
AMELIA M. ARRIA, PH.D., DIRECTOR, CENTER ON YOUNG ADULT HEALTH
AND DEVELOPMENT, UNIVERSITY OF MARYLAND

STATEMENT OF PHIL BAUER

Mr. Bauer. Good morning, Chairman Bono Mack, Ranking Member
Butterfield and members of the subcommittee. My name is Phil
and I am from York, Pennsylvania, and I am here today speaking
as a dad.
If you were to ask any parent what their biggest fear in
life is, their worst nightmare, most would tell it would be
losing a child. We are living that nightmare and it is worse
than we ever could have imagined.
Our youngest son, Mark, died from prescription drugs. His
death was preventable and avoidable, and I believe the
underlying cause was ignorance: my ignorance. Of all the things
I worried about as a dad, abuse of medicine wasn't among them.
Unfortunately, there are many people who continue to
underestimate the dangers of abusing prescription drugs and, as
I know all too well, ignorance can be fatal.
On June 4, 2004, my wife Cookie and I, along with our
oldest son Brian, attended the high school graduation of our
youngest son Mark. As you know, there are many emotions that
come with graduation, and it is a significant milestone and
accomplishment in a young person's life, and the emotions are
not just for the graduate but for their families as well--
pride, happiness, relief, fear, sadness. It is a transition in
life, and some refer to it as the beginning.
The words I would use to describe our emotions at Mark's
graduation are devastation, emptiness and confusion. It marked
the end of our son's life. I can remember so well sitting there
and staring at an empty chair where Mark should have been
sitting with his cap and gown draped over the back of the
chair, and his diploma and yearbook laying on the seat, but
Mark wasn't there.
On May 28, 2004, on what would have been his last day of
high school, just one week before graduation, Mark died. That
morning, I responded to my wife's screams and went to see what
was wrong, and she said that she couldn't wake Mark up. I
started CPR and Cookie called 911. When the emergency personnel
arrived, we followed the ambulance to the hospital, were
escorted to the little room, and then heard the words that our
son was dead. We went back to see him to try to say our
goodbyes, and we cried on his lifeless body. For Cookie and I,
life as we knew it ended that day.
In his room that morning, we found a clear plastic bag of
loose pills. They weren't his, nor did they belong to anyone
else in our family. There were seven different types of pills
in the bag, and 119 pills in all. When the toxicology report
came back 3 months later, it was consistent with what we found
in the bag in his room. Mark died from a lethal mix of
oxycodone, acetaminophen, morphine and stimulants.
Just to give you a little background of our family, when
our sons were born, they became the focal point of our lives.
Their mom quit work and became a stay-at-home mom, and she has
been a terrific mom. To me, being their dad has been the most
rewarding and important part of my life. I was a diaper-
changing, bath giving, story-reading, full-service dad. I took
them everywhere I went, diaper bag and all, and we were
together constantly. Throughout the school years, our sons
never came home to an empty house.
Mark was quiet and an introvert. He didn't let many people
into his life; you had to bring him into yours. When people
took the time to get to know him they found a wonderful, caring
person. Never much for words, he had a terrific sense of humor
and could make you laugh just by his expressions and
mannerisms. He loved sports, especially basketball, and was an
avid weightlifter from the time he was 11. In the later stages
of his life, Mark was 5-foot-9, 175 pounds. He could dunk a
basketball and bench-press 400 lbs. Besides sports, he loved
his family, friends, the Outer Banks of North Carolina,
puppies, Star Wars, playing video games, any Leslie Nielson
movie, shopping with his mom, and making fun of his dad.
One thing we will never know is why Mark chose to take
these pills. We don't know if he was abusing prescription drugs
to get high or self-medicate or to self-regulate. We also don't
know if he had an addiction problem that went undetected, or if
this was just an opportunity that presented itself. I know now
that abuse of medicine can lead to the same dependence and
addiction as that of illicit drugs. They can also be lethal on
the first use, especially if mixed with other substances.
Unfortunately, there are still many people who
underestimate the dangers of abusing prescription drugs. They
believe that abusing these medicines is safer than using
illicit drugs yet it is causing more deaths in our country than
heroin and cocaine combined, and filling up our treatment
centers. Based on the numbers from the CDC, on an average day
in the United States, 31 people will die from prescription
painkillers alone.
From the motivation and inspiration that I draw from Mark's
life and death, I have dedicated myself to do anything possible
to raise awareness about prescription drug abuse. I have
learned so much about this issue over the past several years
and have had many mentors. My journey has included forging
partnerships with organizations and agencies which share my
passion and commitment to combat this issue. I am pleased and
grateful to have the opportunity to now serve on the Parent
Advisory Board of The Partnership at DrugFree.org and to help
promote and support their wonderful tools for parents.
I have also had many opportunities to speak on this topic
at national conferences, to law enforcement, to health care
professionals, to community groups and parent groups throughout
Pennsylvania, and to high school students. I plan to continue
these efforts as long as I am able. Abuse and misuse of
prescription drugs is devastating too many families, causing
crime and other social issues, filling our treatment centers,
and killing too many of our children.
There is no way to tell someone what it is like to lose a
child. You either know what it is like or you don't, and I
truly hope you don't. I am committed to do anything I can to
help others avoid the devastation that Cookie and I live with
every day. Today, I would like to offer my assistance to this
subcommittee, if there is anything at all that I can do to
support or promote your efforts to combat this public health
crisis. Thank you.
[The prepared statement of Mr. Bauer follows:]

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Mrs. Bono Mack. Thank you very much.
Ms. Creedon, you are recognized for 5 minutes.

STATEMENT OF KATHY CREEDON

Ms. Kathy Creedon. Thank you. Good morning, everyone. Thank
you, Chairman Bono Mack. I am so grateful to be here today, and
I hope that my testimony provides valuable information that
will help bring awareness about the epidemic of prescription
drug abuse and diversion we currently face in our Nation.
My story is about the most severe consequences of abusing
prescription drugs. I lost my son Ryan on September 4, 2009, to
an overdose of OxyContin. He was just 21 years old, and I
agreed to come here today because I know there are thousands of
families who are struggling with the pain of this situation
just like I am. I sit here before you today on behalf of all of
us and hope for some victory. My daughter Courtney is here with
me today available to answer any questions after my testimony.
So I just wanted to say that I fought relentlessly to save
Ryan's life, but when addiction is present, it is like spinning
your wheels to try to keep up with their compulsive behavior. I
believe the science that says addiction is a disease and it is
not a moral failure.
As my written testimony details, my son was easily able to
obtain these medications from doctors. He didn't get his pills
from my medicine cabinet. Once I realized he was getting
medication through prescriptions and not on the streets, I
thought I could stop it. He was an adult by this time, and
HIPAA privacy laws made it difficult for me to communicate my
concerns about him abusing pills to his doctors but that did
not stop me. I was able to get my foot in the door more than
once. However, my concerns were mostly ignored and Ryan still
continued to receive OxyContin many times for something as
simple as a backache. In some cases, even when doctors stopped
prescribing OxyContin, they still prescribed other narcotics
that a person with a history of drug addiction should never
have had.
In the last 13 months of Ryan's life, I documented seven
pages of medical records for visits to doctors, urgent care and
emergency rooms. There were six near-death overdoses that
always resulted in a 911 call and hospitalizations, once for 8
days in a lockdown facility. It was a life-or-death struggle
for Ryan many times, and we lived in fear.
I saw my son's addiction progress rapidly once he became
addicted to OxyContin. I believe that was the result of the
aggressive off-label marketing practices of Purdue Pharma. He
was never a candidate to receive such a powerful, addictive
narcotic, and I feel he might be alive today if he had not
discovered OxyContin. He made several attempts to get off the
powerful opiate OxyContin but did not make it longer than 30 to
90 days at a time.
After my son's death, I had the opportunity to discuss all
the careless mistakes made by the HMO that provided his care. I
was told in that meeting that they were not aware of the
dangers of OxyContin at the time my son was receiving it. They
were told it was safer than other pain medications including
methadone, morphine and fentanyl. That confirmed everything I
had read regarding lawsuits and Purdue Pharma, and now my
family was a victim of their misleading practices.
In general, Kaiser Permanente, which was the HMO in our
county, claims it was not aware of the abuse of prescription
drugs taking place among our youth. I was quite surprised
hearing that because I thought that if I knew, surely they
should have known. I then realized how important it was to
figure out a way to bring awareness of the situation to the
medical community as well. I believe that this lack of
understanding contributed to my son's death.
In addition to the fact that they continued prescribing him
narcotics after they knew he was an addict, I feel that
prescription education is so important. Ryan's addiction to
OxyContin resulted in a felony conviction for altering a
prescription at a pharmacy. He was obtaining prescriptions from
many sources at the time that could have been averted if a
prescription monitoring program was in place. Some of those
drugs ended up on the streets. Ryan basically became a drug
dealer to support his addiction to OxyContin. It was unbearable
to see what was happening to my son, at what lengths addiction
will take a person to.
So in closing, I would like to say I will not stop fighting
for my son in his memory. As a result, I have joined with some
mothers to create an organization to fight this epidemic. Our
goal is to make a difference and to try to save lives by
bringing awareness to as many people as possible. So I appeal
to those of you in this room today from the bottom of my heart
to help me make a difference.
I thank you all so much for being here, and I would like to
request that each of you reach out to other Members of
Congress, your colleagues, friends and family to spread the
word about this epidemic, and please be open-minded and learn
all you can. Together we can make a difference. Thank you.
[The prepared statement of Kathy Creedon follows:]

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Mrs. Bono Mack. Thank you, and Courtney. I appreciate your
being here to take questions at the end if we have them, but we
will go to Ms. Rovero for your 5 minutes of questioning.

STATEMENT OF APRIL ROVERO

Ms. Rovero. Chairman Bono Mack and Ranking Member
Butterfield and members of the subcommittee, thank you so much
for having me here today.
On December 18, 2009, just a week before Christmas, my
husband and I received the devastating and inconceivable news
from a Tempe Police Department detective that our youngest son,
Joey Rovero, had had been found dead by friends in his
apartment off campus near Arizona State University, where he
attended college. Over the next few days, as we worked to get
his body returned home to California, where we live, and
funeral arrangements made so we could bury him the day after
Christmas, a story began to unfold that we were completely
stunned by.
We learned that Joey had been invited by a couple of
students from ASU that he knew to travel with them on a 6-hour
journey from Arizona to Rowland Heights, California, on
December 9th, which was just 9 days earlier than his death, to
visit a doctor who was well known for freely prescribing
narcotic medications. All three students walked into this
doctor's office together after the 6-hour drive and all they
all walked out a short time later with prescriptions in hand.
Joey's prescriptions, the first time she had ever seen him and
after just a $75 payment to her, cash, and an X-ray that showed
no problems in hand for him, was prescribed 90 30-milligram
tablets of Roxicodone, 90 350-milligram tablets of Soma and 30
2-milligram tablets of Xanax. He and his friends were directed
to a pharmacy that was at least 35 miles away from this
doctor's office. They drove there together and all of them had
their prescriptions filled with absolutely no questions asked.
We have since learned that both the doctor and the pharmacy had
been under investigation for at least 2-1/2 years before Joey
died. The DEA has since revoked her registration. The medical
board has moved to revoke her license, and that is in process,
and criminal prosecution is expected for Joey's death, among
several others for this doctor.
Joey had never been previously treated for any of the
conditions that were cited in his medical record by the doctor
as the basis for the prescriptions that he received that day,
and there was absolutely no indication that she counseled him
on how dangerous these medications could be if they are misused
or abused, especially with alcohol. So again, just 9 days after
he saw her, he was dead, and that was after partying with
friends in a college, a typical college setting, wee into the
morning. Joey went to sleep and he simply didn't wake up.
The coroner's report indicated that he died from low levels
of Xanax and moderate levels of Roxicodone mixed with alcohol.
His level of alcohol was .013. So he didn't have huge amounts
in his system. The medical examiner indicated that none of the
individual ingredients were lethal but all of them in
combination were. So it was the polymix that was the problem.
Joey was due home for winter break the day after he died,
and the Christmas we expected to share with him never happened.
Instead, we somehow managed to get through the most awful week
of our lives. Stunned, shocked and grieving, we picked out a
gravesite, coffin and clothes for Joey to be buried in. I had
to write an obituary for a young man who had not had time to
develop the lifetime achievements that he should have been able
to cite.
Through it all we struggled to understand how this could
have happened to him, how our perfectly normal family could
have been dealt such a blow. There are really no words that can
adequately describe what my husband, Joey's brother and all of
the other members of our family have experienced with his
death. He was my husband's only biological child, and his
brother is now left with no sibling. As his mother, I truly
feel as though a part of me is gone and just ripped away from
me forever. Our lives were irrevocably changed the night that
he died.
Joey wasn't a troubled young man. I want you to know that.
He was a senior at ASU just 5 months away from graduating. He
was a gifted athlete and a good student, even making the dean's
list at ASU in the fall of 2008. He worked every summer. He
made money. He spent it wisely. He had a loving and caring
relationship with all of his family members. He had tons of
friends all over the country, and over 200 of them appeared at
his funeral to support us and to honor Joey. His life has
affected them also dramatically.
Unfortunately, tragedy struck once again 9 months to the
day after my son's death when one of his two college roommates
shot and killed himself in front of his girlfriend after a
heavy night of drinking and prescription drug abuse. This
problem has just continued to manifest itself in that college
environment. There have been six young men that have died over
the course of the last year at that university alone.
In addition to that, as we have heard today, in Florida we
lost seven people a day, and over 32,000 people a year die from
adverse reactions to medications, so something simply has to be
done with this epidemic.
It is extremely important to me that I do whatever I can to
make a difference. We formed our National Coalition Against
Prescription Drug Abuse, and I speak everywhere I possibly can
to parents, students, educators and community leaders about
this problem.
One thing that I wanted to point out that hasn't been
mentioned today. I have a whole list of recommendations, many
of them have been talked about today. I think the one that I
really want to make sure is mentioned is that the
pharmaceutical industry has been allowed over time to expand
its influence over virtually every facet of American life using
its near-unlimited financial resources to influence the FDA and
other governmental agencies, our educational research
facilities, our legislators, unfortunately, and most
alarmingly, our physicians and other medical providers. They
are influencing medical research, drug trials and are
compensating doctors to prescribe medications they want to
become their next blockbuster drug. The spider web of influence
needs to be dismantled.
Thank you very much for having me here today.
[The prepared statement of Ms. Rovero follows:]

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Mrs. Bono Mack. Thank you, Ms. Rovero.
Mr. Harrison, you are recognized for the 5 minutes, and
please do try to keep an eye on that red light for me.

STATEMENT OF DAN HARRISON

Mr. Harrison. Thank you, Chairwoman Bono Mack, Ranking
Member Butterfield and distinguished members of Commerce,
Manufacturing and Trade Subcommittee for giving me this
opportunity to speak before you today. I am very honored to be
here.
My name is Dan Harrison. I am a tribal member of the
Muskogee Creek Nation of Oklahoma. I currently reside in Palm
Springs, California, for the past 20 years. I worked as a
structural ironworker and achieved apprenticeship status. In
September of 1995, I took a fall on a construction site. My
fall not only resulted in a severe back injury but led to a
life of addiction.
After injuring my back, I went on disability for a couple
of months, then finally went to an orthopedic surgeon, and I
was told that I would need to have surgery which could result
in never achieving 100 percent mobility. I chose not to have
the surgery and developed my own solution of physical therapy
and pain medication. After 90 days, I stopped going to physical
therapy and started drinking to intensify the effects of the
pain medication.
As the days went on, my drinking and opiate use increased
and my life started spiraling out of control. During this time,
my wife and I separated, and I shared custody of our two
daughters. In 1999, I remarried and soon after my third child
was born. This all occurred while I had severe dependence on
opiates and alcohol. The drugs are what got me through the day.
I never had to go back to the doctor's office after my initial
injury. I developed such a strong relationship with the doctor
that I needed only to call and they would refill my
prescription with no questions asked. I would go into local
emergency rooms where the doctor would see me and wave me back
for regular pain injections. I rarely had to resort to the
streets for my medications. Depending on what type of narcotic
I wanted and the method of administering it resulted in which
doctor I would call.
In October of 2008, I decided I wanted to fight for full
custody of my daughters. I felt that the mother was not caring
for them the way I felt they should be cared for. I decided to
call Child Protective Services. After the investigation, they
were removed from the mother's care. When the caseworker showed
up unannounced at my home, I had several cabinets full of
prescription medication. When I was confronted, I admitted to
the recent use of OxyContin, Vicodin, morphine, Lortab,
Demerol, Dilaudid and marijuana.
After hearing myself admit to the amount of drugs in my
system and seeing the caseworker's response, I knew it was time
to make a change. The only way I would ever get custody of my
daughters was to get help. I entered the Family Preservation
Court, otherwise known as Family Dependency Treatment Court.
The Family Preservation Court applies the drug court model to
child welfare cases that involve an allegation of child abuse
or neglect related to substance abuse. The Family Preservation
Court seeks to do what is in the best interest of the family by
providing a safe and secure environment for the child while
intensively intervening in the treatment of the parents'
substance abuse and other comorbidity issues. This approach
also results in better collaboration between agencies and
better compliance with treatment and other family court orders
necessary to improve child protective case outcomes.
Since graduating from the program, I have learned that
there are 2,500 drug courts including over 300 family
dependency treatment courts in the United States. I am humbled
to know that now over 120,000 addicted people a year have the
opportunity for treatment and restoration in these courts, and
I hope that somebody they are available to everyone who needs
them. These courts have been proven to cut up to 40 percent of
the crime rate and produce up to $27 for every dollar invested.
When I first entered the Family Preservation Court, I had
not accepted my problem. I was a little uneasy with myself or
calling the CPS since the investigation turned on me. However,
after my intake and sharing my history with the family
preservation counselor, I realized how bad things had gotten.
Through the Family Preservation Court, upon counseling and
obtained guidance in educating my daughters about the
addiction, I participated in parenting courses that taught me
to effectively communicate with my children, how to create
healthy boundaries. I was given support by my counselors and
peers throughout my struggles with the reunification process.
In 2010, I graduated from the Family Preservation Court.
Today I am thankful that I called the CPS. Without their
intervention, I would not be here today. Family Preservation
Court has helped me realize I needed to get help for myself as
well as my family. As a result of completing the program and
completing other parenting courses, I have vowed to work
diligently with the program and CPS side by side to work to do
some outreach work for the ones that are still suffering from
prescription drug use in the local community as well as the
tribal community in southern California.
I thank you for allowing me to come here and share just a
little bit of my story. I realize today that I am a miracle
that sits here because of my addiction and going through the
process of my recovery, I realized how serious this epidemic is
today.
So thank you for inviting me here today to share my story.
I am very humbled by that. Thank you very much.
[The prepared statement of Mr. Harrison follows:]

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Mrs. Bono Mack. Thank you, Mr. Harrison.
Dr. Boyd, you are recognized.

STATEMENT OF CAROL BOYD

Ms. Boyd. Thank you. Thank you for inviting me today. My
comments draw on my research that is primarily funded by the
NIH, among other sources. I have been studying this for the
past 10 years.
You have heard today that over the past 15 years,
prescriptions for controlled medications have nearly doubled
for adolescents and young adults, and these come from office
visits, from ER visits and, significantly in this age group,
from oral surgeons. And once the youth have the pills in their
hand, they are at risk for diverting them. Approximately 10
percent of adolescents in a given year have diverted their pain
medicine. Fifteen percent have diverted their stimulant
medications. And like other researchers, we find that girls are
more likely to divert by loaning and giving and boys are more
likely to divert by selling. There are also socioeconomic
differences among these adolescents.
Approximately 10 percent of all youth will divert their
pills to their parents. Overall, one in six adolescents with
legal prescriptions will be approached in a given year to
divert their medicines, and in some cases, they will be asked
to rent them. It is usually stimulants in this age group that
are being diverted but not exclusively. We have found that the
more elite the school and the more elite the university, the
more likely diversion is to occur, and again, it is often
stimulants. This is not to say that opiates are not the problem
either, though.
Motives to divert as well as to use diverted medications
are wide ranging, and it should not be assumed that the motives
always involve getting high. Indeed, motives are one of the
reasons that this problem is so difficult to prevent. So I
would like to share with three cases from our own studies, and
they highlight what we found in our research.
The first one is a 16-year-old teen. She is an honor
student. She was going to homecoming. She had a new boyfriend.
Four hours before the event, she got a migraine headache, and
she went to her mother and her mother gave her one of her own
hydrocodone tablets that she had leftover from her
hysterectomy. The teen took it, went to the event. When I
interviewed her, she had had a great time and she did not use
hydrocodone again.
The second case, a 15-year-old boy attends an elite high
school and he is having trouble getting his work done. His best
friend has a prescription for Adderall and keeps it on the
dresser in the house. And when his friend leaves the house, his
friend takes the Adderall. When I talked to this young man, he
said well, you know, everyone in my school is using it,
everyone uses it to study.
And then in the third case, this is a high school girl. She
did have a history of alcohol abuse. She was given an oxycodone
tablet from her girlfriend, who had also gotten it for oral
surgery. She wanted to experiment to see what it does. Now,
this is a girl that also was abusing alcohol. She crushed and
snorted the pill and she found herself continuing to use what
she called Oxy when she wanted to party with her friend.
Now, these cases represent what we have found in our
research. First, diversion in this age group usually occurs
among family and friends. Two, there are gender differences.
Three, it usually involves one primary prescription and it is
often from oral surgeons and dentists. Four, the diverted
medicine is often started for the purpose of self-treatment so
that you see youth thinking that they are going to use it for a
headache or that they are going to study harder but then once
they start using it, they have it available to them. And
finally, the controlled medications are readily available. They
are advertised on television. We do advertise controlled
medications on television with direct-to-consumer marketing.
And they are not stored properly nor are they disposed of, and
I hear this time and again from youth.
The adolescent girl that was in my case three is the one
that is at the absolute highest risk. She is a poly-drug user
and she is using for recreational purposes. It is these
sensation-seeking youth that our data find have the biggest
problems and are at the greatest risk for drug addiction and
death.
Most social scientists end their talk by saying we need
more data, and I am going to tell you that as well. It is
difficult to understand why a country such as ours has data
from 2006. We need regional data. We need national data that
has more nuance, that tells us the complexity of the problem.
But policymakers can also do something. The FDA has
recently stipulated that medicine bottles need to carry the
schedule on them. I called my son, who has a prescription for
Adderall, before I came here today and I said did you pick up
your prescription bottle, and he said yes, and I said, well,
what about the labeling, did it look different. No, he said, it
doesn't look any different. I said come on, Joseph, look, see
if it looks different; oh, yes, maybe. This isn't enough. I
have a prescription that tells me on the back not to use it
with grapefruit juice. These prescription bottles need to be
clearly labeled that it is unlawful to share the medication,
that they need to be stored correctly, and how they need to be
disposed of.
The solution to this problem lies in the recognition that
it is far more complex than actually street drug use, and it is
going to require cooperation with pharmaceutical companies,
health care providers, families, young people and policymakers.
Thank you.
[The prepared statement of Ms. Boyd follows:]

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Mrs. Bono Mack. Thank you.
Dr. Arria.

STATEMENT OF AMELIA ARRIA

Ms. Arria. Chairman Bono Mack, Ranking Member Butterfield,
members of the subcommittee, thank you for this opportunity to
testify on the problem as it manifest among our Nation's youth.
I come at this issue as a researcher at the University of
Maryland and the Treatment Research Institute in Philadelphia,
but I am a mom too.
Since 2003, with my dedicated staff, I have led the College
Life Study, a NIDA-funded study of more than 1,200 college
students. Consider our findings regarding non-medical use. By
the fourth year of college, 13 percent used a tranquilizer, 23
percent an analgesic and 30 percent a stimulant without a
prescription. We found that more than one-third with
prescriptions shared or sold their medications, usually to a
friend. Most commonly diverted are stimulants such as Adderall
with a 62 percent diversion rate. And individuals who divert
prescription drugs are typically non-medical users themselves.
Let me sharpen the focus on this particular aspect of the
problems, stimulants. They are widely available and attractive
to students with high task demands, especially those
experiencing academic difficulties. There is a popular
assumption that taking stimulants non-medically confers an
academic edge and is therefore beneficial. Headlines
referencing smart drugs perpetuate the notion that non-medical
prescription stimulant use increases academic performance.
Scientific evidence tells us quite the opposite. It is not the
academically successful students who use them but the
unsuccessful ones. We know that non-medical users compared to
non-users are more likely to be dependent on alcohol and/or
marijuana, skip class more frequently and spend less time
studying, and digging even deeper, we see that these academic
problems are related to heavy drinking and marijuana use. What
the research shows is that non-medical prescription stimulant
use is an unsuccessful shortcut, an attempt to compensate for
declining academic performance and is a red flag for an
underlying alcohol or drug problem.
What can policymakers do about prescription drug abuse? The
single best thing is to tighten the chain of custody that
ultimately governs supply. For example, put in place better
prescription monitoring programs, reform physician dosing
practices and create timely surveillance databases. National
data are often old and State-level data are not even available
to researchers.
The prescription drug problem has complicated the landscape
of existing drug threats. It does not occur in isolation.
Individuals who use prescription drugs non-medically are very
likely to be heavy drinkers and/or illicit drug users.
Therefore, in addition to deal with this devastating symptom,
we must redouble our efforts to develop innovative solutions to
the root issue, that is, the larger public health problem of
drug use and addiction in the United States.
What specific strategies should be proposed? Today is
recommend two things regarding prevention and intervention.
One, modernize the Nation's infrastructure for early detection.
We can identify those who are at highest risk for drug
problems, just like knowing who is at risk for other chronic
health conditions, with an approach that involves standardized
assessments, early intervention and promotes teamwork between
parents, physicians and educators. We can put these young
people back on track to fulfill their potential. To this end,
NIH research has yielded valuable information about risk and
resiliency, the interplay between genetics and the environment
and the natural history and course of addiction. Effective
solutions to this enormous public health threat will require
continued funding for NIH research.
Number two: connect the dots between drug use and academic
problems. This link cannot be ignored any longer. Making this
connection loud and clear will get the attention of parents who
want more than anything else to see their child succeed. Tacit
approval by parents and students of underage drinking as
normative and college as a 5-year party, especially when there
are stimulants drugs as a last resort, is completely misguided
by regrettably an all too common notion. Similarly, we must
engage the leaders of our education system who are concerned
about the high school dropout crisis and less than optimal
college graduation rates. They must recognize the very real and
contributory role of drug use to poor academic achievement.
Sustaining our economy and navigating future challenges will
require a clear mind and a sharp focus, which is inconsistent
with underage drinking, excessive drinking, illicit and non-
medical prescription drug use.
Again, thank you for shedding light on this continuing
public health problem and allowing me to contribute to the
discussion on solutions.
[The prepared statement of Ms. Arria follows:]

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Mrs. Bono Mack. Thank you. I thank you all the panelists
very much. Certainly the parents who are hurting, I thank you
for your advocacy and your passion turned towards helping
others.
Dr. Boyd, the statistics I am looking at completely dispute
what you are saying. As I look at the Drug Abuse Warning
Network statistics as published by SAMHSA, you said that
stimulants are the problem and you also say that opiate
addiction has doubled. Did I not hear that correctly?
Ms. Boyd. No, that prescriptions for controlled medications
for young adults and adolescents--I think this is what you are
referring to--has nearly doubled since 2007.
Mrs. Bono Mack. Now, this is not specific to adolescents,
but when I look at these numbers for the increase of emergency
department visits, now, old data, but from 2004 to 2009
stimulants all together, again not specific to adolescents but
I would think the trend would be similar, 20,490 admitted to
ERs in the year 2004. That increased to 25,889 by 2009, a
5,000-person increase over those years, while oxycodone and
combinations thereof, 41,701 in 2004. One would think that the
crisis is similar, that that would double, but in fact it
actually increased to 148,449. So you spent the bulk of your
time talking about stimulants but I am not aware particularly,
and I am sorry I don't have the data here, but would you say
that the trend line for stimulants and fatalities for
stimulants is similar to opiates and OxyContin?
Ms. Boyd. No, I wouldn't, and actually I did not intend to
give the impression that I was mostly talking about stimulants
actually. When I was speaking of the controlled medications, I
was speaking of the four schedules and that for instance, 10
percent in our sample had diverted their pain medication where
15 percent had diverted stimulants.
Mrs. Bono Mack. Let me jump to Ms. Creedon here and even to
Mr. Harrison, and thank God that you are here as a recovering
addict. I am so proud of your courage. Thank you for being
here. And to Kathy Creedon, this is the scientific community
and you guys have lived it in the real world. Is this just
diversion from the simple places they see? Ms. Creedon, in your
testimony, I wish you had gone on a little bit more. You talk a
great deal, and you mentioned you have seven pages of
documentation that show the runaround and what they call the
smurfing, the great lengths your son went to that had nothing
to do with your medicine cabinet. Would you be willing to
submit your seven pages and 72 entries of medical history?
Would you be able to submit those things for the Congressional
record so we can take a look at all of that? But are you
hearing on the real street side of what is really happening out
there in California and the homes? Is it paralleling what the
scientists are saying here?
Ms. Kathy Creedon. That the drugs are coming from parents'
medicine cabinets? Is that the question?
Mrs. Bono Mack. Perhaps I just--I am a little on edge. It
almost seems that you act as if the 16-year-old honor student
was given hydrocodone, Dr. Boyd, and the teen went to the
event, she had a great time but she never used hydrocodone
again. So it seems to downplay, and you are acting as if the
diversion is, well, Mom gave it to a 16-year-old, she had a
great time at a party, and I just take issue with that because
this is a mother who never, ever dreamt of doing such a thing.
Ms. Boyd. Absolutely, but speaking as a social scientist,
this is also happening so that when we look at the data on
diversion, we see all kinds of diversion and we see that also
parents are role modeling, share medications that are
controlled. The mother shouldn't have had extra hydrocodone.
Mrs. Bono Mack. OK, but Ms. Creedon, you had no
hydrocodone, you had no oxycodone. Can you speak a little bit
about the great lengths your son went to that had nothing to do
with this? You are like Ms. Rovero and Mr. Bauer, a loving
parent doing your best to raise a teenager, or young Ms.
Creedon.
Ms. Courtney Creedon. If I can speak to this, I mean, I
think the reputation certainly is out there, and we have heard
a lot of that today that I guess there were some statistics
floating around that most people get these drugs from their
parents' medicine cabinets, but in our case, that did not
happen. We never had any of these drugs in our house. My mother
never condoned using drugs. I mean, when we do submit these
records, I mean, Ryan went out of his way to visit every doctor
imaginable and finagle every aspect of the system to make this
work, and surprisingly, it wasn't that difficult. So it is kind
of hard for us to sit here and hear people talk about I guess
parent responsibility when really I think the bigger issue is
responsibility or rather irresponsibility of the medical
community in that none of these drugs came from our home. All
of these drugs that Ryan used and the drugs he died from were
obtained legally from licensed physicians.
Mrs. Bono Mack. Thank you. I have to yield now to the
ranking member, Mr. Butterfield, but we will have a second and
third round of questioning. So Mr. Butterfield is recognized.
Mr. Butterfield. Let me thank the chairman for convening
this very important hearing today. Those of us on this side of
the aisle are also acutely aware of the pervasive problem that
we have with prescription drug abuse, and so the hearing today
is very timely and I want to thank the witnesses for their
testimony.
In my prior life, I was a trial judge in North Carolina. I
did that for 15 years, and so I have seen and heard heart-
wrenching stories for many years over my career, and I want to
extend my personal condolences and concern to those families
who have been directly affected.
I want to just ask one or two questions. I won't belabor
this unnecessarily but let me start this way. Prescription drug
abusers do so for a variety of reasons, and I think we
recognize that today. There are many reasons that contribute to
this problem. Some people use them recreationally, some seeking
their euphoric, relaxing or energizing effects. Other people
with or without a prescription use them inappropriately seeking
to alleviate minor pain and treat a perceived illness or even
to manage stress. Still other people use prescription drugs for
their intended purpose but obtain them without a prescription.
To Dr. Arria and Dr. Boyd, do we have data in percentage
terms which demonstrate either for the population as a whole or
for high school- or college-age individuals why prescription
drugs are being used? In other words, for what reasons by
percentage do young people decide to take prescription drugs
without a prescription?
Ms. Arria. The percentages vary by class of prescription
drugs, so for stimulants, I would say about three-quarters of
people who use stimulants take them to increase concentration,
to study and the scenario sort of plays itself out that I
explained where they are having academic difficulties. Only a
small percentage of them will crush stimulants to get high. On
the analgesic side, many, many more, a higher percentage,
probably about 80 percent, will use them to get high and a very
small minority will use them because of curiosity reasons or
for other reasons. And for the tranquilizers, we see a lot of
self-medication going on where there might be an underlying
mental health issue. So it varies by class, and that is for the
college age-population, young adult populations. We do not have
that level of data at the national level. The national survey
on drug use and health does not collect that level of
information for us.
Ms. Boyd. And I studied 12- to 17-year-olds so it is a
younger group, and they are less likely to use any drugs, the
12-year-olds and 13-year-olds, so you see some differences. We
also see differences by drug class, and they mimic much of what
Dr. Aria said with the exception being the opioids where
disproportionately the younger the child with the opioid, the
more likely they say they are treating pain. Once they get
older so that now they are into 11th and 12th grade, now when
they are using diverted opioid medications, they are using it
to experiment, to get high, to help them sleep, but that may be
because they are using stimulants or they are drinking or
partying, but so it would be for sensation-seeking or
recreational reasons.
Mr. Butterfield. Can we quantify what percentage of users
snort as opposed to crushing the medication? What percentage
are snorting it? Do we know?
Ms. Boyd. Of 12- to 17-year-olds?
Mr. Butterfield. Well, your age group, yes.
Ms. Boyd. Relatively few are snorting it, and it depends by
grade. Twelve-year-olds and 13-year-olds are not snorting it.
We see about 5 to 10 percent snorting it by the time they get
into high school.
Mr. Butterfield. What about combining it with alcohol?
Ms. Boyd. They all combine it with alcohol.
Mr. Butterfield. That is a common----
Ms. Boyd. Absolutely. Our data show that any youth that is
using the opioid products to get high or to sensation seek or
for recreational purposes are using other drugs as well, and
they are also using other prescription medications.
Mr. Butterfield. Would that be the same in the older age
groups as well, Dr. Arria?
Ms. Arria. What we find is that there is always a history
of excessive drinking or a history of marijuana involvement,
and in some cases they are using it at the same time
concurrently during the same session. For instance, in our
data, 88 percent of the non-medical prescription drug users had
a history of marijuana use in the past year.
Mr. Butterfield. So there are similarities between the 12
to 17 and the 18 and above?
Ms. Boyd. There are, and particularly when you get to 16-,
17- and 18-year-olds. The younger ones, which I am also
studying, who are in middle school, they do look different.
Mr. Butterfield. Well, let me thank you and thank all of
you for your testimony. I yield back.
Mrs. Bono Mack. Thank you, and I do ask unanimous consent
that the information that I requested from Ms. Creedon be
allowed to be included in the record. No objection? OK. So
ordered.
Mrs. Bono Mack. Dr. Arria, you keep mentioning the history,
the history, the history of use. It is my belief as a mother
who just got through high school that the powerful nature of
these painkillers that our kids do not have a chance. Can you
speak to the adolescent brain, specifically what does happen
when they get that tablet of OxyContin? Can you speak also to a
pharm party and explain what that is?
Ms. Arria. Sure. I think it is very true that the addictive
potential of opioid analgesics trump what we are talking about
when we see marijuana, other drugs. So what really appears to
be the issue is that because it is more typical for alcohol and
marijuana to be used at younger ages, there are some people who
are more predisposed to using substances. We know that. And the
adolescent brain is more set up to take risks naturally, and so
that combination of being an adolescent and having a propensity
for addiction sets up a course where you get involved with
alcohol and marijuana and then it exposes you to drug-using
peers. Like I said, you begin to lose interest in other things,
you get involved in prescription drugs and then you get a very,
very highly addictive substance and that is what you are
talking about when they don't stand a chance. So if they have a
propensity for addiction plus they are in this age of
adolescence----
Mrs. Bono Mack. I have no Ph.D., but I beg to differ that
if they have a predisposition to addiction, because I believe
that every human being----
Ms. Arria. I stand corrected.
Mrs. Bono Mack [continuing]. Has the potential to be
addicted.
Ms. Arria. One hundred percent of people have some
propensity for addiction.
Mrs. Bono Mack. I am sorry. Can you repeat that?
Ms. Arria. One hundred percent of people are at risk for
addiction if they are exposed to addictive substances.
Mrs. Bono Mack. And then an adolescent then?
Ms. Arria. An adolescent would be even more so because of
their risk-taking behaviors.
Mrs. Bono Mack. But risk-taking, a white pill to them is a
lot less risky than meth?
Ms. Arria. Well, what we find is that in terms of, we have
done studies on perceived risk and the risk of medications
falls in between marijuana and cocaine, so they don't see it as
less risky than marijuana. They see taking prescription drugs
medically or non-medically as more risky than marijuana but
less risky than cocaine, so that is where it falls.
Mrs. Bono Mack. Briefly, let me just lead you to the answer
that I want to hear on another question, pharm parties. It is
my understanding, is it not true, that kids now go to parties,
throw bunches of pills into a bowl and grab whatever they can
and swallow it to be risky?
Ms. Arria. We have heard of that happening. We are not sure
how often it happens. What we do know is that the variety of
drugs used is much--there is much more variety of different
drugs used on the same occasion than there were years ago. That
is what we know now.
Mrs. Bono Mack. Thank you.
Mr. Harrison, how helpful now is the medical community? If
you walk into a pharmacy, do you have the ability to tell your
pharmacist I am a recovering addict, please don't prescribe my
drug of choice to me or help me if I do? Do you have that
ability? Are they helpful to you now?
Mr. Harrison. I went through a process of a second back
surgery with a 12-month sobriety, and it was difficult for me
to have them administer more intravenous drugs to me because I
was going through recovery, but I haven't yet attempted to gain
any access since my recovery, so I haven't attempted to talk to
any doctors that I have dealt with in the past. Them knowing
the severity of my injury, in the past, like I said, I had
built a relationship with them and I see them from time to time
in the community, and so access was real easy. But since my
recovery, 30 months in recovery, and I haven't yet attempted to
go back.
Mrs. Bono Mack. Well, congratulations on your 30 months.
Mr. Bauer, are you finding a good avenue for your advocacy
and making a difference out there?
Mr. Bauer. Yes.
Mrs. Bono Mack. Good answer. Nice, short and sweet. OK. I
will yield to Mr. Butterfield for the next 5 minutes.
Mr. Butterfield. Thank you very much, Madam Chairman.
During one of the earlier panels--and I apologize for not
being here. I forewarned the chairman that I had another
commitment this morning and I could not resolve. But during one
of the panels this morning, a lot of time was devoted to
discussing monitoring programs. I believe databases are an
important tool that should be in our toolbox, but we need to
treat the non-medical use of prescription drugs with many
different tools, with multiple tools and treat it as a public
health issue, not just a law enforcement issue. For example, we
need better education of patients and parents and friends and
doctors and dentists and every person in society.
Dr. Boyd, in your testimony you mentioned better labeling
as one of those tools. Can you describe what you would envision
to be on a label and would this be on all prescription drugs or
just those that are the most risky if diverted?
Ms. Boyd. Well, I am also a nurse and I would like to see
better labeling on all medications, but let me direct my
attention to the controlled medications that are more likely to
be diverted and abused. I would recommend that we label them
that it is unlawful to distribute them. Many, many of the kids
that I interview do not know, and parents do not know, that
mother of the girl going to homecoming, she didn't know she was
doing something illegal. They should know it. It should be
labeled on the bottom. There should also be directions on how
to dispose of extra medicine that is left in the bottle so it
is not sitting in the medicine cabinet. And finally, not only
should they know where to dispose of it and that it is unlawful
to distribute it but they should also know that it has
addictive potential and abuse potential. Many medications I
have gotten have been labeled more fully than the medications
that are controlled.
Mr. Butterfield. All right. Let me come to the other end of
the table. Ms. Creedon, aside from labeling--and I like Dr.
Boyd's assessment of this--but aside from labeling, what can we
do to increase public awareness of prescription drug abuse? We
have got to become more proactive so other families do not have
the tragedy that you have experienced. What can we do?
Ms. Kathy Creedon. You know, that is a really good
question. I don't know the answer yet but I intend to hopefully
be able to make a difference by this organization that I have
started and our goal is to reach out, first of all, to students
in high schools, middle school, college age, the parents, and I
really would like to reach out to the medical community as well
because that was a specific problem in my son's, well, that led
up to his death. In these seven pages, I document it, if I
could just take a minute, in the beginning where my daughter
and I had a face-to-face meeting with the director of the
medical facility where we said to him, Ryan has an addiction
problem, and like I said, because of privacy laws, we were not
able to speak about certain things, you know, because of
breaking laws. But he did tell me that he would go and speak to
the physician that Ryan had an appointment with 2 days later.
That conversation apparently never took place, and I just feel
that if he would have taken our conversation seriously coming
from a family member of Ryan's history of drug abuse, that
could have stopped the other six pages of his hospitalizations
and everything else that went on. So for me particularly, I
feel that the medical community doesn't take addiction
seriously because maybe they are just not aware, you know, of
what a few pills can do to somebody. In my son's case, it led
to his death.
Mr. Butterfield. What about public service announcements on
TV channels that are watched by young people?
Ms. Kathy Creedon. That is one of the things that we hope
to be able to do.
Mr. Butterfield. MTV and BET and some of the other
channels.
Ms. Kathy Creedon. Absolutely. There are some things
already being done directly to young people on the Web sites
and things that they listen to about the dangers of
prescription drug abuse.
Mr. Butterfield. We need to do it and we need to do it
repetitively.
Ms. Kathy Creedon. Exactly.
Mr. Butterfield. One thing we have learned in Congress, if
you say something over and over and over again, people will
listen and sometimes believe it.
Ms. Kathy Creedon. And that is what I read in all the
educator material that I have been researching lately is that
it does have to be repetitive and so it would almost mean being
present on a high school property on a weekly basis just over
and over telling them the dangers of the drugs before they go
to a party on Friday night.
Mr. Butterfield. Thank you. Thank you again. I yield back.
Mrs. Bono Mack. All right. Thank you. We will do 5 more
minutes and then we will conclude the panel and move on to the
next, unless you would like another five, I am certainly fine
with it.
Mr. Butterfield. We are going to have votes in about an
hour.
Mrs. Bono Mack. Dr. Boyd, back to you. Labeling--my
understanding through the years of my research on OxyContin
that actually the label is what turned kids on to the ability
for the misuse. I think that labeling is not going to be the
answer. I don't know how old your son is, but I believe that it
goes back to me to the DEA and the FDA and the supply chain and
figuring out how this stuff is getting out there and why we are
taking back hundreds of pounds of this stuff, whatever the
astronomical number is. It has got to be beyond labeling.
Let me just jump to Ms. Creedon again. Again, your
testimony is terrific, but you spoke about the medical
community, your frustrations with them, but since Ryan's death
you have worked with the medical community and the doctors
overseeing the HMO, and it is my understanding that they did
learn a lot from you and that they have agreed to change their
prescribing practice for such powerful painkillers. Is that
true, and have you followed up on that, that you are able to
actually educate in your community, your HMO, and get a change?
Ms. Kathy Creedon. Yes, that is true, and I was very happy
that they were receptive to hearing the information. I printed
out a lot of information from the Internet and shared it with
them, and in fact, the medical director told me that he took
the information that I gave him and presented it in front of a
staff meeting that they had, and they in fact after my meeting
made a policy within their organization that covers
approximately 3,000 physicians and over 300,000 members that
those physicians could no longer prescribe OxyContin for the
patients unless they had fourth-stage cancer and they had tried
everything else. So I feel that was a huge victory that the
education that I gave them made that change, and I haven't been
able to follow up with the outcome. I intend to do that, but I
don't know right now if that is still happening.
Mrs. Bono Mack. I congratulate you on that, and it goes to
Ms. Rovero, in your testimony you say the same thing. You say
that your son had never been treated for any of the conditions
listed on the doctor's record as the basis for her prescription
for the powerful painkillers. Were you surprised by how easy it
was for him to get access to those medications?
Ms. Rovero. Not only surprised, I was shocked. I had never
heard the term ``pill mill.'' I had not heard about dirty
doctors. This last year has been a complete education for me.
Shocked, absolutely shocked, and I have learned that that is
the case throughout the country. I talk now to parents all over
the place, California to Florida, and it is happening. There
are so many unscrupulous doctors out there that are giving it
out, they are in a pill mill kind of environment, but it is not
just those doctors, it is also those that are really well
meaning but they are not really well educated about pain
management treatment. I have been told, I don't know if it is
true for sure, but I have been told that doctors get less pain
management training than veterinarians do, and that is
horrifying to think about, but if it is true, my gosh.
Mrs. Bono Mack. Would you agree with that statement, Dr.
Boyd, Dr. Arria? Do you know about the level of training that
physicians do get before they can prescribe these things?
Ms. Arria. I know it has gotten better but I know that I
can speak to the addiction medicine side. They really are not
given proper training at the graduate medical education level
on addictive disease.
Mrs. Bono Mack. Dr. Boyd?
Ms. Boyd. I agree with that. It is just inadequate.
Mrs. Bono Mack. Thank you. And I will just use my last
minute. I think we agree with Ms. Creedon, Ms. Rovero, on
trying to limit the scope on when it is prescribed. I think
that is something we can push for in Washington. But I really
just want to thank you all very much for your commitment, your
advocacy to this, and I don't know where it is going to go. I
am frustrated last night in my research to see that there was a
Senate hearing in 2002 that is very much like the one we are
holding today. I think that is frustrating, and I think we are
failing. It is a tough time for budget cuts and we all have
questions on how we spend our money, but we can do a better job
and I think the American people want an effective government,
and in this case, it is not being effective.
So I look forward to working with each and every one of
you, and if you had another five, I am willing to yield to the
gentleman. If not, we will take a quick recess and seat the
next panel. Thank you very much.
[Recess.]
Mrs. Bono Mack. First up will be Sean Clarkin, Executive
Vice President of Partnership for a Drug-Free America. Also
joining us is General Arthur Dean, Chairman and CEO of the
Community Anti-Drug Coalitions of America. Then we will have
Dr. Coster, Senior Vice President of the Generic Pharmaceutical
Association. Our fourth panelist is Kendra Martello, Assistant
General Counsel, Pharmaceutical Research and Manufacturers of
America. Also testifying, Michael Mayer, President of Frank
Mayer and Associates. And our sixth witness is Patrick Coyne,
Registered Nurse, testifying on behalf of the Oncology Nursing
Society.
Welcome, everyone. Thank you much for being here today. I
think you know the drill, 5 minutes, green, yellow, red. In
America, we generally know what that means. So just please make
sure you press the microphone to turn it on, and Mr. Clarkin,
you are recognized for 5 minutes.

STATEMENTS OF SEAN CLARKIN, EXECUTIVE VICE PRESIDENT AND
DIRECTOR OF STRATEGY, THE PARTNERSHIP AT DRUGFREE.ORG; ARTHUR
T. DEAN, CHAIRMAN AND CEO, COMMUNITY ANTI-DRUG COALITIONS OF
AMERICA; JOHN M. COSTER, PH.D., R.PH., SENIOR VICE PRESIDENT,
GOVERNMENT AFFAIRS, GENERIC PHARMACEUTICAL ASSOCIATION; KENDRA
MARTELLO, ASSISTANT GENERAL COUNSEL, PHARMACEUTICAL RESEARCH
AND MANUFACTURERS OF AMERICA; MICHAEL MAYER, PRESIDENT,
MEDRETURN, LLC; AND PATRICK COYNE, R.N., M.S.N., CLINICAL
DIRECTOR, THOMAS PALLIATIVE CARE UNIT, VIRGINIA COMMONWEALTH
UNIVERSITY MEDICAL CENTER, ON BEHALF OF THE ONCOLOGY NURSING
SOCIETY

STATEMENT OF SEAN CLARKIN

Mr. Clarkin. Good morning, Chairman Bono Mack, Ranking
Member Butterfield, members of the subcommittee, thank you for
inviting me to testify about the problem of prescription drug
abuse and the diversion of prescription medicine.
The abuse of prescription medications, legal substances of
tremendous benefit if used appropriately, is the single most
troubling phenomenon on today's drug landscape. According to
the 2010 Partnership Attitude Tracking Study, the PATS study,
one in four, 25 percent of teens, report taking a prescription
drug not prescribed for them by a doctor at least once in their
lives and more than one in five teens, 23 percent, has used a
prescription pain reliever not prescribed for them by a doctor.
Why have we as a Nation not been able to reduce this highly
risky behavior? There are several reasons, many of which we
have already heard today. The first is ready access. These
substances are readily available to teens in their own medicine
cabinets and the medicine cabinets of friends and family, and
very often they are available for free. Nearly half, 47
percent, of teens in our PATS survey say that it is easy to get
these drugs from parents' medicine cabinets, and more than a
third say it is available everywhere.
Another reason is low perception of risk, the low
perception of risk that is associated with abusing prescription
drugs. Partnership research shows that less half of teens see
great risk in trying prescription pain relievers such as
Vicodin or OxyContin that a doctor did not prescribe for them.
Low perception of risk coupled with easy availability is a
recipe for an ongoing problem.
The third reason that we have heard a lot about, especially
from Dr. Boyd, is the motivation to abuse. We have
traditionally thought of teens abusing illegal drugs and
alcohol either to party or to self-medication for some serious
problem or disorder, adolescent depression, for example. But
our research, like Dr. Boyd's, shows that teens appear to be
abusing these drugs in a utilitarian way, using stimulants to
help them cram for a test or to lose weight, pain relievers to
escape some of the pressure they feel to perform academically,
tranquilizers to wind down at the end of a stressful day. Once
these substances have become integrated into teens' lived and
abused as study or relaxation aids, it may become increasingly
difficult to persuade teens that these are drugs are
unnecessary or unsafe when taken without a prescription.
The fourth reason, and this is a particular focus of the
partnerships, is the lack of parental activism in prevention of
this behavior. Parents who are usually our most valuable ally
in preventing teen drug use find it hard to understand the
scale and purposefulness with which many of today's teens are
abusing medications, and it is not immediately clear to these
parents that the prime source of supply for abusable
prescription drugs may well be their own medicine cabinet. Many
parents themselves, moreover, are misusing or perhaps abusing
prescription drugs without a prescription. In research that we
did in 2007, 28 percent of parents said that they themselves
had used a prescription drug without having a prescription for
it, and 8 percent of those parents said that they had given
their teenaged child a prescription drug that was not
prescribed for them.
Finally, the reason we have not been able to reduce teen
abuse of prescription medications is that our efforts as a
Nation have been inadequate, at least to date. There simply has
not been sufficient public attention or resources dedicated to
this threat. The backdrop to all of this is that the national
drug prevention infrastructure has been eroding for the past
years as the budget for the National Youth Anti-Drug Media
Campaign has shrunk significantly, the Safe and Drug-Free
Schools and Communities State Grant has been eliminated, and
changes have been proposed to the state prevention and
treatment block grant that could put prevention funding in
jeopardy. With dwindling resources, it is impossible for
government to be able to mount the kind of effort that is
necessary.
We know that if there is, when there is a well-funded
effort to educate parents about the dangers of prescription
drug abuse, we can increase awareness and we can make a
difference. In the first half of 2008, the Office of National
Drug Policy's National Youth Anti-Drug Media Campaign devoted
$14 million with which the media match was a $28 million effort
to a parent-targeted campaign aimed at raising awareness about
the risks of medicine abuse and motivating parents to take
action. The campaign actually in terms of parents' perceptions
of the problem and intent to take action was demonstrably
successful. This shows that a major public education campaign
can help to turn the tide on this entrenched behavior. The
media campaign's funding is in jeopardy and may even be
eliminated in the coming year, so we can't assume that that
campaign will be around to deliver this message. The private
sector will need to help finance a campaign of the magnitude
necessary to change the attitudes that underlie this behavior.
While the partnership is grateful for the unrestricted
support we have received from a number of pharmaceutical
companies, if our Nation is going to reduce teen abuse of
prescription medication, we need to step up efforts
dramatically. We need a sustained, multi-year effort funded by
the pharmaceutical industry, the generic drug manufacturers and
other key stakeholders to first support a major independent
paid media campaign alerting consumers to the risks of abusing
medicine and the importance of safeguarding and safely
disposing of medicine. This effort might including tagging the
pharmaceutical industry's large inventory of direct-to-consumer
advertising and pointing viewers towards an objective and
comprehensive online prevention resource. Second, we need to
educate and enlist prescribers, pharmacists and other health
care professionals. Third, we need to educate policymakers so
that we can promote policies that will help reduce both the
supply of and the demand for prescription drugs of abuse. And
finally, implement an evaluation tool that would measure and
hold this program accountable.
In conclusion, at the partnership we believe that the abuse
of prescription medications, legal substances of great benefit
when used properly, is the single most troubling phenomenon on
today's drug abuse landscape. We appreciate the time and the
attention that the subcommittee is giving to raising awareness
and looking for ways to reduce the abuse of prescription drugs
in our country. The Partnership at Drugfree.org stands ready to
work with the subcommittee on this and other substance abuse
matters. Thank you very much.
[The prepared statement of Mr. Clarkin follows:]

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Mrs. Bono Mack. Thank you, Mr. Clarkin.
General Dean, you are recognized for your 5 minutes.

STATEMENT OF ARTHUR T. DEAN

Mr. Dean. Chairman Bono Mack, Ranking Member Butterfield
and other distinguished members of the subcommittee, thank you
for the opportunity to testify today on behalf of Community
Anti-Drug Coalitions of America, CADCA, and our more than 5,000
community coalitions nationwide. I am pleased to provide you
with CADCA's perspective on the complex problem of prescription
drug abuse.
CADCA has been on the front lines addressing prescription
drug abuse for nearly 10 years. We have hosted town hall
meetings, developed publications and toolkits for coalitions,
and produced television programs on this subject. In 2009, we
were fortunate enough to conduct a rally with over 1,000
community leaders on Capitol Hill to raise the awareness of
over-the-counter as well as Rx abuse. CADCA recognizes that the
misuse and abuse of prescription drugs is a multidimensional
problem that demands comprehensive, coordinated solutions at
all levels, local, State and national. Population-level changes
in substance abuse including prescription drug abuse can be
achieved by a comprehensive, data-driven approach. This
approach mobilizes key community sectors that work together to
educate, reduce access and availability, and change perceptions
as well as social norms. Where this infrastructure is in place,
communities have successfully prevented and pushed back against
a variety of drug problems such as marijuana, methamphetamines,
K2 and the misuse and abuse of prescription drugs.
The Drug-Free Community, DFC program is the best example of
a comprehensive community-wide approach being taken to scale
nationwide. Since 1998, the DFC program has been a central
bipartisan component of our Nation's drug reduction strategy. A
recent evaluation of the program found that youth drug, alcohol
and tobacco use are significantly lower in DFC-funded
communities than in communities without a DFC coalition.
CADCA trains DFC grantees and other community anti-drug
coalitions to execute seven evidence-based strategies to effect
community change for drug use. Coalitions across the country
are implementing these strategies, and these strategies range
from raising awareness to changing policies, and they are
achieving measurable results and reducing local prescription
drug abuse rates.
In the interest of time, I would like to share just one
example from Caribou, Maine. The Aroostook coalition used a
multisector approach to identify prescription drug problems and
to craft a strategic action plan to address them. The coalition
did the following: one, they implemented a comprehensive social
marketing campaign; two, they provided training to health care
providers about proper prescribing; three, promoted and funded
a prescription drug take-back program; and four, created a
monthly mailer for health care providers that lists individuals
charged with prescription drug-related crimes in their
communities. As a result of this data-driven multisector
approach, the coalition achieved significant outcomes. Through
the coalition's effort, the county has Maine's lowest rate of
past 30-day prescription drug use among high school students.
Similar coalition examples are highlighted in my testimony, and
I would invite those to your attention.
CADCA's primary message today to this committee is that
community coalitions are evidence-based and effective and
should be utilized as a major component of any prescription
drug prevention strategy. We recommend that the coalition model
be implemented in concert with a number of other key
approaches. For example, CADCA supports the expansion of
effective prescription drug monitoring programs to ensure
adequate coverage in every State. The data from these programs
can also help identify hot spots and appropriately direct the
attention to other resources. We need enhanced education
opportunities for training for medical and dental professions.
We also need increased awareness and education about the
danger, proper storage and disposal of drugs. We support
enhanced opportunities to make prescription take-back programs
routinely available. We strongly support increased law
enforcement to remedy such things as pill mills. Our nation
needs to embrace and enhance all these strategies. We need to
expand the number of DFC-funded communities. And finally, we
need to increase training at the local level so that more
communities can effectively address this major public health
and safety threat.
I thank you for the opportunity to testify before you today
and applaud you for your great work. Thank you.
[The prepared statement of Mr. Dean follows:]

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Mrs. Bono Mack. Thank you, General, and we are honored that
you are here, and I thank you for your service and that you
came under the wire, because there is one person I couldn't
gavel down, and that would be you, sir.
Mr. Dean. And thank you for your great support and on a
continuing basis. We appreciate it very much.
Mrs. Bono Mack. Thank you. I look forward to our continued
work together.
Dr. Coster, you are recognized for 5 minutes.

STATEMENT OF JOHN COSTER

Mr. Coster. Thank you. Good morning, Chairwoman Bono Mack,
Ranking Member Butterfield, Congressman Lance, members of the
subcommittee. I am John Coster, Senior Vice President of
Government Affairs at the Generic Pharmaceutical Association
and a licensed pharmacist. On behalf of GPhA and our member
companies, thank you for calling this hearing and for the
opportunity to testify.
Let me begin by giving some background on the role of the
generic drug industry in the United States. About 75 percent of
all prescriptions are filled with generic medications, although
that percentage does vary by therapeutic class. We are proud
that our industry helps make high-quality, safe, effective
prescription medications more affordable for millions of
Americans while saving the health care system billions of
dollars each year.
GPhA's member companies manufacture FDA-approved generic
versions of brand-name drugs in all therapeutic categories
including prescription painkillers. We are as concerned as the
members of this committee when medications that are made to
improve lives or alleviate pain are abused. We believe that
address this issue, as you have heard from the previous
witnesses, will require a continued coordination among Federal
and State agencies, State, local and Federal law enforcement,
health professionals, drug manufacturers, pharmacists, patients
and their families. Because it is a multifaceted problem, it
requires a multifaceted solution.
As we work together to shape public policy to end the
misuse of pain medications, we must recognize that the
overwhelming majority of individuals including millions of
seniors and cancer patients do rely on these important drugs
for their proper pain treatment. We are absolutely committed to
the safe and reliable manufacturing and delivery of generic
drugs.
As an industry, we have invested millions of dollars into
technologies and delivery systems to help assure that our
products reach their destinations safely and securely. For
example, with respect to opioid medications, the DEA has a
closed system of distribution to prevent diversion. Our
industry works with the DEA to assure that these products do
not fall into the hands of abusers. For example, the DEA
administers drug allotment and accountability systems to assure
against the loss of diversion of controlled substances.
Recent studies suggest that the problem of prescription
drug abuse stems not from drugs that have escaped legitimate
supply chain or been obtained illegally through the black
market but instead from those that were legally prescribed and
available in the home. Why are these medicines sitting in
medicine cabinets? Shouldn't patients have already taken them?
It is not uncommon to find many medicine cabinets in America
are stocked with unused prescription drugs. Some of these may
be for mild conditions such as allergy while others may be
unused medications that were prescribed to treat the discomfort
of a surgery. Many Americans have no recourse to return these
unused medications, especially controlled substances, because
Federal law prohibits the transfer of controlled substances
from an ultimate user to anyone other than law enforcement.
This will soon change as DEA implements the Safe and Secure
Drug Disposal Act, which will permit ultimate users such as
patients with excess controlled substances in their medicine
cabinets to return them to DEA registrants such as willing
pharmacists so they can be destroyed.
What has our industry been doing to help address this
problem? In general, we have tried to support efforts that are
dedicated to raising awareness to the dangers of prescription
drug abuse as well as the need to properly dispose of unneeded
or unwanted prescription medications. We think education is a
key component to this. For example, we support efforts such as
the American Medicine Chest Challenge, which is a community-
based public health initiative with law enforcement partnership
to raise awareness about the dangers of drug abuse. We are
pleased to let you know that we will be partnering with PhRMA
to produce a public service announcement that will promote the
upcoming DEA Take Back Day on April 30th, which we hope will be
as successful as the one from last fall.
We are also a board member of NCPIE, the National Council
on Prescription Information and Education, a broad-based
coalition on addressing raising awareness about prescription
drug abuse. For example, NCPIE most recently developed a
college resource kit to help educate students about the dangers
of prescription drug misuse.
In addition, over the last few years our industry companies
have focused efforts in this area by joining with the brand-
name industry, patient groups and the FDA on working on a REMS
program for long-acting and extended-release opioid
medications. REMS are special programs that are used by FDA to
help prevent adverse outcomes in patients. At this point, I
don't believe the FDA has implemented that program yet.
Madam Chairwoman, we applaud you for the countless hours
you have devoted to raising awareness about this issue and the
great work you have done. With the cooperation of physicians,
law enforcement and others, we can expand education efforts,
keep our supply chain safe and secure, and help to ensure that
patients and family members are not alone in this fight. We
thank you for holding this hearing, and I would be happy to
answer any questions you may have.
[The prepared statement of Mr. Coster follows:]

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Mrs. Bono Mack. Thank you, Dr. Coster.
Ms. Martello.

STATEMENT OF KENDRA MARTELLO

Ms. Martello. Good morning. Thank you, Madam Chairman and
distinguished members of the subcommittee, Ranking Member
Butterfield and Congressman Lance. My name is Kendra Martello
and I am pleased to offer this testimony today on behalf of the
Pharmaceutical Research and Manufacturers of America, or PhRMA.
PhRMA's members represent America's leading pharmaceutical
research and biotechnology companies. Last year, our members
alone invested over $49 billion in discovering and developing
new medicines. Industry wide, research and investment reached
more than $67 billion last year, a record.
The prescription medicines our members research and develop
are life-saving and life-enhancing medicines that allow
patients to live longer, healthier and more productive lives
when used appropriately and as intended. It is important as we
consider the non-medical use of prescription medicines that we
also balance the need to maintain patient access to these
medicines for legitimate medical use.
We believe addressing the public health problem of
prescription drug abuse is a shared responsibility. It requires
a comprehensive, consistent and sustained approach and
commitment from a wide range of stakeholders including
prescribers and pharmacists. No one manufacturer, brand or
generic, recognizing that approximately 75 percent of the
prescriptions are for generic medicines, no one trade
association and no one stakeholder group is solely responsible
for implementing a solution that will truly be effective. We
all must work together to achieve a common goal, and PhRMA and
our member companies are committed to being part of the
solution.
An important part of our educational message surrounds the
appropriate use of medicines, which can reduce health care
costs overall. Data also show that the majority who misuse or
abuse prescription medicines do obtain them from a friend or a
family member. We believe that education can have a significant
impact in helping to inform the public and reducing the overall
rates of prescription drug abuse. We have developed four simple
messages as part of our education effort on this important
issue.
First, take your medication exactly as prescribed. Second,
store all medicines in a safe manner out of the sight and reach
of children and adolescents in particular. Third, don't share
your medicines with anyone including friends or relatives. And
fourth, promptly dispose of any unused medicine in a safe
manner, either through the household trash or an appropriate
take-back program such as the one administered by the DEA. In
fact, to help further this last message, PhRMA partnered with
the U.S. Fish and Wildlife Service and the American Pharmacists
Association in 2007 to create the Smart Disposal Program, which
educates consumers about how they may safely dispose of most
medicines through the household trash.
PhRMA and our member companies have also undertaken
significant educational efforts regarding prescription drug
abuse. For example, we have recently worked with the Washington
Health Foundation and the State Attorney General to develop
education for college students and with Dare America to help
educate students in grades 5 through 12. We also believe
specific educational efforts must be targeted towards
prescribers and pharmacists and could help them to detect and
refer for treatment those who may be abusing prescription
drugs.
Other ideas that could have a significant impact on
reducing the rate of non-medical use of prescription drugs:
first, increase the use of and improvements to State
prescription drug monitoring programs which can be an important
tool in preventing and detecting abusers and referring them for
treatment. Second, reauthorize NASPER, which provides grants
for these State monitoring tools and which is legislation that
PhRMA has supported. Third, increase penalties for and
enforcement against pill mills, medicine diverters and those
who go outside the legitimate medical supply chain including
rogue Internet drug sellers. Fourth, work with FDA and others
to facilitate the development of medicines to treat addiction
and mechanisms to make medicines less susceptible to abuse. And
finally, work with the DEA as it develops regulations to allow
ultimate users and long-term care facilities to return
controlled substance for disposal.
In conclusion, prescription medicines when used as
prescribed are critical to improving and extending patient
health. However, when they are misused or abused, they can be
dangerous and even deadly. No one solution to this public
health problem exists. Education is of critical importance and
it is a key first step but we must not stop there, and all
stakeholders have a role to play in helping to develop
solutions. We are committed to working with the subcommittee,
members of Congress and other stakeholders on this important
public health issue. Thank you.
[The prepared statement of Ms. Martello follows:]

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Mrs. Bono Mack. Thank you.
Mr. Mayer.

STATEMENT OF MICHAEL S. MAYER

Mr. Mayer. Madam Chair, Ranking Member Butterfield and Mr.
Lance, I appreciate the opportunity to appear before you today.
I am here today representing MedReturn. MedReturn is a
subsidiary of Frank Mayer and Associates, an 80-year-old
family-owned company in Grafton, Wisconsin. Our core business
is designing and manufacturing in-store displayers,
merchandisers and interactive kiosks for Fortune 500 companies.
Our involvement in the issue of prescription drug abuse
stems from the commitment to provide a safe, secure,
sustainable and environmentally friendly way to help law
enforcement agencies and communities collect unwanted or
expired prescription medication and over-the-counter drugs.
The genesis of MedReturn began over 3 years ago when I
challenged the associates in my company to research and develop
new ideas. The challenge was called WITT, Wish I'd Thought of
That. As we began investigating the prescription drug disposal
issue, we quickly became aware of the management of
prescription medication and drugs that sit unused or expired in
our medicine cabinets. We began researching and looking for
existing take-back programs and realized there was no
consistent method or program available. Over a 2-1/2-year
period, we developed, prototyped, presented, tested, improved
and produced the MedReturn drug collection unit. Noting the
importance of education, we incorporated a sizable graphic
panel that States and communities can customize.
We launched MedReturn at the International Association of
Chiefs of Police conference in October 2010. To date, our drug
collection has been placed in 50 police and sheriffs
departments across 11 States. We helped implement only the
second county-wide ongoing drug collection program in the
United States.
Attached statements from law enforcement agencies confirm
the positive response of their communities to sustained drug
collection. Lieutenant Tim Doney of the Medford, Oregon, Police
Department notes usage of their program is so heavy, they are
emptying the collection unit at least 4 days a week. Other e-
mail feedback we have received illustrates the demand for
permanent medicine return programs. Sheriff David Peterson of
Waushara County, Wisconsin, reports collecting 200 to 250
pounds of medication in 3 months, and Lieutenant Wayne Strong
believes the Madison, Wisconsin, Police Department has
collected 230 pounds in that same time frame.
What started as an effort to supplement our core business
has quickly evolved in a passionate desire to be a smart part
of the solution to the prescription drug abuse problem. We have
devoted and continue to devote significant amounts of time and
money to let State and local law enforcement agencies and
community groups know we are available to answer inquiries. We
know the DEA is working toward finalizing regulations that
implement the Secure and Responsible Drug Disposal Act of 2010.
We have talked with hundreds of law enforcement officers. Many
of them are asking us how to implement their programs. Others
believe the collection and disposal process is too complicated.
Others insist on recording and inventorying all collected
medications and others don't realize the scope of the problem.
We believe a lack of understanding may be a deterrent to
establishing a permanent take-back program. We also find a
varied interpretation of what constitutes safe disposal. Some
departments accept pills in a bottle while others want pills
placed in plastic bags. Others will hold the collected contents
until the annual Take Back Day. One officer admitted he
collected the drugs but then flushed them down the toilet.
Ideally, we would like to refer potential users of MedReturn to
a central resource that outlines Federal and State requirements
and best practices.
At MedReturn, our vision is a sustainable, nationwide
program as widely available as plastic, glass and paper
recycling are today. By our calculation, there are some 30,000
communities that could benefit from a take-back program. We are
in the process of seeking corporate or foundation partners that
might speed this process.
We appreciate the amount of attention prescription drug
abuse is receiving from Members of Congress and the
Administration. We hope you will continue to consider the
challenges of those who want to establish a sustainable drug
collection program at the grassroots level. We stand ready to
serve as a resource in any way that is appropriate. Thank you.
[The prepared statement of Mr. Mayer follows:]

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Mrs. Bono Mack. Thank you, Mr. Mayer.
Mr. Coyne.

STATEMENT OF PATRICK COYNE

Mr. Coyne. Good morning, Madam Chair and distinguished
members of the subcommittee. It is a great honor that I testify
today regarding pain management and the potential implications
for patients in need of pain relief from diagnosis to
survivorship.
My name is Patrick Coyne. I have been a clinical nurse
specialist for over 25 years, focusing on pain management and
symptom control, typically in cancer patients. I am the
Clinical Director of the Thomas Palliative Care Services within
the Massey Cancer Center at Virginia Commonwealth University in
Richmond. In my role, I care for individuals on a daily basis
who are dealing with life-limiting diseases and significant
issues with pain. The patients I care for are from all walks of
life, living in both urban and rural areas throughout the
Commonwealth. I also teach in the schools of nursing and
schools of medicine in our university and beyond. Today I
represent the Oncology Nurses Society, ONS, the largest
professional oncology group in the United States composed of
more than 35,000 nurses and other health care providers.
I would be naive not to recognize that the problem of
opiate diversion is a very severe one and can destroy both
patients, families and communities. More must be done to treat
the significant issue. However, what about those patients who
live daily with intractable, unrelenting pain? Daily, I
encounter patients who will not see their next birthday and
often travel hours to see someone within our institution for
appropriate analgesia because their local health care provider
is uncomfortable with prescribing the medications the patients
need or fearful that their license may be revoked for using too
much opiate pain medication.
This population of patients is frail, dealing with
countless issues, which I hope I never have to, and often has
no voice. I hope to be their voice and ensure their comfort. I
also wish to support their privacy so that nobody needs to know
about their illness unless they choose to release this
information.
The challenges within pain management are many. Individuals
respond differently to different medications including
oxycodone. Many clinicians receive far inadequate training in
prescribing analgesics, assessing pain and other treatment
options and have false concerns regarding the role of
analgesics. Certain areas in this country have limited
resources for managing pain well. We know adequate pain
management as demonstrated in several studies can increase both
survival and quality of life for patients with life-limiting
diseases. Caregivers often suffer from depression and financial
impact when pain is poorly controlled. Pain is a serious and
costly public health issue. Unmanaged pain is a tragedy. What
really seems to be the tragedy is this patient population may
suffer because of those conducting illegal activities.
Pain management is challenging in any population. Cancer
patients fear pain as do their families, but what of cancer
survivors who suffer daily in pain but are disease-free?
Consider those individuals with pain from poor cardiac output,
sickle cell disease or burn injuries as examples of just a few
populations of patients who may be at risk without the
availability of certain opiates. Addiction and misuse of
analgesics is exceedingly rare in patients in pain yet they may
carry the burden and suffer the decisions made by others.
All discussion about the issue of opiate pain medications
needs a balanced exploration of the risks but also the benefits
of the medications when used appropriately. Limiting a pain
medication, any medication, might take a very safe option away
from countless patients living with moderate or severe pain.
Education of prescribers is clearly needed to better assess
pain and implement appropriate treatment options but limiting
options may ruin many individuals' lives.
I have treated many patients with oxycodone, OxyContin and
other analgesics, mostly cancer patients who have not tolerated
other medications or did not get adequate relief from other
opiate or non-opiate pain medications. Patients and their
families need better education and support regarding the safe
and appropriate use of, storage and disposal of medications.
The needs of countless patients suffering in pain need to be
part of this and any discussion.
I want to thank you for your time and commitment regarding
this exceedingly important subject. I have devoted my life to
pain management and I fear that many patients I care for may
suffer if poor decisions are made regarding pain management,
and I welcome your time and questions. Thank you very much.
[The prepared statement of Mr. Coyne follows:]

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Mrs. Bono Mack. Thank you to all of the panelists for your
expert testimony.
Mr. Coyle, first of all, I applaud you in your efforts and
think that we share the same goals. My father was suffering
from the last stages of cancer just a couple of years ago, and
I watched him go through it, so I appreciate what you see in a
clinical setting. But at the same time, I have seen people
suffering from opiate withdrawal, so I too care about those
people and the pain that they suffer and the life of living
with that addiction. Once you are an addict, as you know, you
are an addict for the rest of your life. So hopefully we can
continue to work to make sure that the people who you need to
treat are treated to the best of your ability and we can also
keep the drugs out of the hands of the bad guys.
And it goes to Ms. Martello. I keep hearing this
reoccurring thing that it is coming from friends and family and
medicine chests, and I can't believe that you all are serious
when you think that is the big problem. You know, just this
week there is an article about another prescription drug sting
with 15 arrested in San Diego, California. Now, I will grant
that they were arrested because they had prescription pills
that they didn't have prescriptions for but they also had
cocaine, methamphetamine and other street drugs, but can we
take our head of the sand and quit acting like it is all
grandma's medicine chest and admit the fact--and let me just go
to Dr. Coster.
You are a licensed pharmacist. In 2008, the Partnership for
a Drug-Free America or Drugfree.org's president, Steve Pasierb,
he said in a Reuters interview, and I quote, ``OxyContin is
pharmaceutical heroin. There is really no difference between
the two.'' Do you care to explain the difference
pharmacologically between OxyContin and heroin, how far off it
is?
Mr. Coster. To be honest, Madam Chairman, it has been so
long that I have been in pharmacy school, I would probably get
it wrong if I did it, so if you like, we can provide you an
explanation after, but at this point I probably wouldn't be
able to do it.
Mrs. Bono Mack. Well, it is my understanding, it is one
molecule off. I mean, that would be a fair characterization,
and certainly you can submit that to me in writing later, but
would you say that OxyContin and heroin the way they are
consumed by the human body, the only difference is the delivery
mechanism?
Mr. Coster. You know, again, I wouldn't be able to comment
on that, you know, from a pharmacological perspective. I
wouldn't want to give you any incorrect information or
inaccurate information, so again, if you like, I would be happy
to provide whatever I can in writing after the hearing.
Mrs. Bono Mack. Well, it is my belief and my contention
that they are pretty darn near the same, but to both you and
Ms. Martello, you keep using ``underadherence'' and
``medication noncompliance'' and those terms in your testimony.
When you talk about the problem with underadherence and
noncompliance, are you lumping in therapeutics, antibiotics,
other drugs into that category? Can you really say that there
is a problem that people are not taking all 30 days of
OxyContin when they are prescribed it?
Ms. Martello. I think appropriate use of medicines can go a
long way to helping patients improve their health conditions,
and as I said in my testimony----
Mrs. Bono Mack. Including 30 days of OxyContin?
Ms. Martello [continuing]. This is a shared responsibility.
This is something that I think as we have heard throughout the
testimony this morning, there are a variety of stakeholders
that have a role to play.
Mrs. Bono Mack. Now, let me get back to this simple
question. Are you saying that it is for the patient's benefit
that they take 30 days' worth of painkillers like OxyContin?
Ms. Martello. I think health care professionals are on the
front line of this every day, and I think part of the
educational effort that we can engage in----
Mrs. Bono Mack. No, this is a yes or no. And to Dr. Coster
too, this is a yes or no.
Mr. Coster. I mean, I can give you a personal experience if
this helps. I had surgery a couple years ago, and when I left
the physician said here is a prescription for, I can't remember
if it was 30 or 50, for OxyContin, and I went to get it filled,
and he said if you need them, take them. So I guess he thought
that in my case I might need two or I might need, you know, a
week's worth. So I think, and again, not to justify how these
drugs are used, but some people, I guess some physicians feel
like I will give you this quantity, and if you need them, take
them, if you don't, they don't really tell them what to do with
them. So I don't know if it is a yes or no answer but in terms
of a personal----
Mrs. Bono Mack. No, the question is, is extending the life,
extending the quality of life--you are lumping this in, it
seems to me, with therapeutic drugs or antibiotic or something
when you talk about underadherence of drugs.
Mr. Coster. Again, in terms of like if you are taking a
blood pressure medication where you absolutely have to take it
every day or a cholesterol medication----
Mrs. Bono Mack. But we are not focused on those drugs
today.
Mr. Coster. No, I know that.
Mrs. Bono Mack. But we keep saying underadherence,
underadherence.
Mr. Coster. Again, I am not a prescriber, but in the case
of pain, oftentimes you get prescribed a quantity of medication
because a physician doesn't know, for example, how you are
going to tolerate a certain procedure. He might say you might
need for 5 days, you might need these for 10 days. Again, I am
not justifying this. I am just saying as a pharmacist who has
seen a lot of patients come in and fill prescriptions for pain
where the patient says I may not need all these or why the
doctor did give me all these, you are trained to tell the
patient that the physician probably gave these to you because
he is not sure how many you are going to actually need.
Mrs. Bono Mack. My time has expired, but we will come back
to that, and I am sure Mr. Mayer is very appreciative of the
over-prescriptions.
Mr. Butterfield, you are recognized for 5 minutes.
Mr. Butterfield. Thank you, Madam Chairman.
As we have heard, 70 percent of non-medical prescription
drug users get those drugs from family or friends. It can be
given to them, it can be sold. They can actually unfortunately
steal it from others. We also know that the family medicine
cabinet is bulging with unused and no longer needed medicines.
Disposing of these medicines properly must be a priority and we
must work to reduce their negative impact on the environment.
When people do not have a safe place outside of the home where
they can dispose of their unused drugs, they typically flush
them, causing them to ultimately end up in our waterways.
Question: I understand that a number of communities have
created take-back days in which medicines are safely collected
by law enforcement. Also, the Secure and Responsible Drug
Disposal Act sponsored in the House by Mr. Inslee of Washington
will allow more people and places to collect these unused
medicines. This question is for Mr. Clarkin. Does the
partnership that you represent have any examples of times when
a take-back operation works particularly well?
Mr. Clarkin. Not specific instances in specific
communities, but we first of all support the whole take-back
program that the DEA has spearheaded in the most recent take-
back initiative, I think it was pointed out earlier was
terrifically successful in terms of the quantities of drugs
that were actually brought back and safely disposed of, and we
look forward to supporting the DEA at the April 30th take back.
Mr. Butterfield. Thank you.
Next to General Dean. Thank you for your service to our
country. What branch were you a part of?
Mr. Dean. The U.S. Army.
Mr. Butterfield. Ever stationed at Fort Bragg?
Mr. Dean. [Inaudible.]
Mr. Butterfield. All right. And thank you for that.
According to reporting by the North County California Times--I
almost said North Carolina--the North County California Times a
couple years ago, military doctors wrote service members nearly
3.8 million prescriptions for painkillers up from less than
900,000 10 years ago. The Defense Department estimates that
abuse of prescription drugs in the military is double that of
the general population. First of all, do you agree or disagree
with that, that military drug abuse is more and probably twice
as much?
Mrs. Bono Mack. Excuse me. General, would you please turn
your microphone on?
Mr. Dean. I agree that the military has a significant
problem with this issue. I don't have the exact statistics on
it.
Mr. Butterfield. But you have no reason to disagree with
that statistic?
Mr. Dean. I have every reason to agree with that.
Mr. Butterfield. And it appears that one study in 2009 even
found that 20 percent of Marines had abused prescription drugs,
mostly painkillers, at some point in the previous year. Our
active service members face significant anxiety overseas and
many live through pain every day when they are on duty, but if
they develop a physical dependence or addiction to prescription
drugs, it can follow them back home to their civilian life, and
I have seen it all of my life.
General, what should the Administration do with regard to
training veterans hospitals to be on high alert for this type
of abuse?
Mr. Dean. I think it is a multifaceted approach that needs
to be taken in order to assist our military members and their
families and the communities that they reside in. I have had
some discussions, my organization has, with the Army. I have
another meeting scheduled with them in the very near future to
address just this issue of helping them be more holistic in
their approach of dealing with this issue that is not only
soldier focused but also for the family members as well as the
other civilians as well.
Mr. Butterfield. Are there other programs geared to
prescription drug abuse by veterans? For example, veterans may
receive health insurance from the Federal Government. Are the
insurers instructed to be on the lookout for abuse and not
simply for the sake of law enforcement but really to help the
veteran?
Mr. Dean. The answer is yes. I have a board member who runs
the VA substance abuse center, the big VA center in Atlanta,
Dr. Karen Drexler, and the VA has programs but the resources
and the number of people that they have in my opinion--I am not
speaking for the VA--needs to be expanded and there needs to be
greater information provided and there need to be greater
educational programs, but do they have the programs, yes, but
my understanding would be that there needs to be a substantial
enhancement in those programs.
Mr. Butterfield. Thank you. Thank you, one and all. I yield
back.
Mrs. Bono Mack. Thank you, Mr. Butterfield. The chair
recognizes Mr. Lance for 5 minutes.
Mr. Lance. Thank you very much, Madam Chair, and good
afternoon to you all. I find this testimony very interesting. I
don't have the honor of representing Fort Bragg but I do
represent the district in the United States that has more
medical and pharmaceutical employment than any other district
in this country, and certainly this is an issue in the district
as well as across the country.
To Dr. Coster or to Ms. Martello or to both of you
regarding the risk evaluation and mitigation strategy at the
FDA, based upon your expertise, do you feel that it has
contributed to the mitigation of prescription drug diversion
and has there been any unforeseen consequence such as access
issues for patients?
Ms. Martello. When we look at policies in this area,
certainly balancing the need between legitimate patient access
and ensuring that the product's benefits continue to outweigh
its risks is an important public health consideration and I
think those are the issues that are currently being grappled
with. The FDA has a variety of tools in its arsenal to make
sure that the product's benefits continue to outweigh the risks
of any product.
Mr. Lance. Dr. Coster?
Mr. Coster. Yes, sure. It is an excellent question,
Congressman. There is so much focus and attention that has been
placed on this program, and even though it has not yet been
fully implemented by the FDA, I think just by the attention it
has received, it has caused physicians to maybe look more
closely on how they prescribe and patients on what they do in
terms of taking these medications, but I agree with Ms.
Martello that any program put in place like this should assure
that it doesn't interfere with the appropriate prescribing of
these medications, the appropriate dispensing of them and that
patients in pain are able to get them, and I think the agency
itself is struggling with what that right balance is right now
for these extended-release and long-acting opioid products.
Mr. Lance. Thank you.
And to Ms. Martello, you state, and I agree with you, that
you do not want to see barriers to patient access for needed
prescription medicines. You highlight one potential barrier
could be unnecessarily restrictive drug control regulations and
practices. Could you give us in a little greater detail what
you mean by that?
Ms. Martello. I think health care providers play a pivotal
role in helping to ensure that patients have access to the
medicines that they need and so we would want to have health
care providers and pharmacists frankly to be part of this
conversation to help ensure that they can work with patients
and counsel them on medication management and using medicines
appropriately as prescribed.
Mr. Lance. Thank you.
And to General Dean, thank you, sir, for your service to
our Nation. Have you seen greater abuse given the fact that we
now have military operations in the field in both Iraq and
Afghanistan and has there been a tracking of this in
relationship to other times when we have had our military
personnel in combat situations?
Mr. Dean. Well, as you know, I have been retired for a few
years so I am giving you information from my perspective and
not from within the Department of Defense, but clearly the
protracted wars that we have been in and the extensive number
of severely wounded soldiers and other member of the armed
forces have contributed to an increased number of them needing
and benefiting over a long period of time from these medicines,
and as a result of that, it is clear, and my friends have told
me, that there is an increasing number of them who
unfortunately are now abusing them and they are trying to find
ways to combat that. Just recently, we had an officer as senior
as a three-star general admit that he was addicted to pain
medicine. So it is an issue. I am not actively involved in it
now. I am looking to work with the military services to help
them build some procedures that would get at training and
education around military bases that would help combat this,
but it is a significant issue.
Mr. Lance. Thank you very much. And Madam Chair, I yield
back my remaining 4 seconds.
Mrs. Bono Mack. Thank you for your generosity. I recognize
myself for 5 minutes again and say that it is so unfortunate,
General, that we are hearing that this is truly carrying over
into our troops, and it really makes a huge punctuation point
on how important it is that we are doing this here today, so I
thank you for your testimony and for being here.
Quickly, just to point out, thought, that the FDA does not
currently have a REMS program for long-acting and extended-
release opioids, so it is not currently in place, and I am
wondering how long it will take for them to do it and how many
deaths will it take for them to do it, and I am curious, you
know, fen-phen was taken off the market really quickly. If
either one of the two pharmaceutical reps can explain to me why
fen-phen would have been removed from the market or some of
these drugs that are so quickly and what the difference is
between that and these opioids that are now up to tens of
thousands of deaths a year.
Ms. Martello. It would be inappropriate for me to
substitute my judgment for that of the independent scientific
expert agency, the FDA, which evaluates the safety and efficacy
of all marketed medicines, and so from my perspective, I think
it would be inappropriate for me to comment on that.
Mrs. Bono Mack. OK, fine. Then let me use my time with
somebody who can actually comment, if that is all right.
Mr. Clarkin, any of you, can you explain to me why the
abusive opioid drugs because a problem so quickly, the trend
lines screaming up there, anybody who is out there in the field
in the real world?
Mr. Clarkin. I think there is probably a combination of
factors, and clearly supply has been a factor. I think the
environment of marketing, direct-to-consumer marketing in the
pharmaceutical industry, has expanded the abuse of prescription
drugs not just prescription opioids.
Mrs. Bono Mack. In fairness, I have never seen an
advertisement ever for OxyContin.
Mr. Clarkin. That is correct, but my point is, that the
direct-to-consumer advertising, and I think there is fairly
robust literature on this, is creating a sense of a reliance on
medicine to address a variety of different ills and so we see
in our research, which I mentioned, and Dr. Boyd sees the same
thing, an increasing reliance on the part of teens, at least,
to be addressing not just to self-medicate or recreate with
these substances but to address life management issues, and I
think that is linked in some measure, not entirely but in some
measure, to aggressive marketing.
Mrs. Bono Mack. Thank you. Does the partnership have any
explanation just from an observing standpoint why rogue
pharmacies specialize in hydrocodone versus oxycodone or other
controlled substances yet the pill mills specialize in
oxycodone instead? Has anybody figured out that discrepancy?
Mr. Clarkin. I don't have an answer for you on that.
Mrs. Bono Mack. Anybody? No? OK. Mr. Mayer, the take-back
program, what do you see as the key features of a successful,
always available program?
Mr. Mayer. Local community support. Education is going to
be the biggest key. Letting the communities, the public know
that there is a sustainable take-back program within their
community. The program that we put together, the county-wide
program which is in our county actually was a combination of
news media and support from local newspapers but it was also
putting flyers in the pharmacies, letting individuals know when
they pick up their prescriptions that they can dispose of
unused, expired at the local law enforcement agencies.
Mrs. Bono Mack. Terrific. Thank you.
Mr. Mayer. Education is the key.
Mrs. Bono Mack. OK. Dr. Coster, when you see the statistics
and graphs that Governor Scott presented earlier showing the
disproportionate share of drugs dispensed from Florida and
national statistics on drug diversion, do you think that the
DEA and FDA quota system needs to be reevaluated in light of
the high percentage of diversion, particularly in Florida?
Mr. Coster. Well, I know the way the quota system works
now. It is based on a combination of factors both in terms of
what the data show in terms of demand, FDA data and other data
that feed into DEA and then DEA then determines how much our
individuals manufacturers can make. You know, in terms of the
situation in Florida, it sounded like part of the issue down
there was that they didn't have a prescription monitoring
program which hopefully that will deter some of the abuse. But
we are happy to talk with the committee and the DEA about
whether the system needs to be recalibrated.
Mrs. Bono Mack. Let me just back that up. I am sorry. I am
down to my last 15 seconds. You just said the quota is based
upon the demand? Isn't that the problem here? If anybody wants
it, then they are allowed to make it. That is the simple--that
is it. That is the way you just explained it.
Mr. Coster. Well, again, I am not intricately familiar with
how the FDA determines its actual quotas so I just gave you a
broad overview, so as I said, maybe it is time that that whole
system is looked at again in terms of how those quotas are
determined based upon what is happening in the State.
Mrs. Bono Mack. Thank you, Doctor.
Mr. Butterfield, you are recognized.
Mr. Butterfield. Thank you.
Let me drill down on prevention for just a moment if I can.
If we can prevent abuse, we know we can save millions of
dollars and, more importantly, we can save many, many precious
lives. As prepared by the Office of National Drug Control
Policy, the 2010 National Drug Control Strategy called for
Federal, State, and local entities as well as non-governmental
partners to seek earlier intervention opportunities in health
care. One of the opportunities that the strategy highlights is
working with physicians to achieve consensus standards on
opiate painkiller prescribing.
Mr. Clarkin, I am going to go back to you. What do you
believe are the best ways to seize this opportunity? How
specifically should stakeholders unite around consensus
standards? For example, should task forces or working groups
that include doctors, nurses, pharmacists and others be
created? What role can the partnership play in such a process?
Mr. Clarkin. I think we have heard a lot today pointing to
the need for prescriber education, first of all, on appropriate
prescription of opioids and other medications. One of the
measures that the partnership supports is the explicit linkage
of education of prescribers to their DEA registration renewal
every 3 years, so I believe that is an important piece and one
that Director Kerlikowske also cited when he spoke here
earlier. I think the dialog too between health care
professionals, whether they are prescribers or pharmacists, the
dialog between those health care professionals and consumers,
particularly parents, needs to be much more mindful of the
risks of abuse, the risks of addiction, and I know one of the
pieces that is under discussion as part of the long-term opioid
REMS and one that the partnership supports is the adoption of
effective prescriber-patient agreements at the point of
prescription so that the patient very clearly understands the
risks. First of all, there is a screener so that the doctor is
aware if the patient indeed is particularly susceptible to
addiction but the patient is also aware of the risks of abuse,
the risks of addiction and the need to effectively safeguard
meds and dispose of them appropriately.
Mr. Butterfield. Perfect timing. We have just been called
to the floor. You heard the buzzer. I am going to have to yield
back. Thank you.
Mrs. Bono Mack. I thank the gentleman. And does the
gentleman from----
Mr. Lance. I do not, Madam Chair, have any more questions.
I yield to you.
Mrs. Bono Mack. I thank the gentleman for yielding back,
and I believe that we should wrap this thing up.
Before I do, I would like to ask unanimous consent that
these four items that we have previously discussed with the
minority be included in the record.
Mr. Butterfield. No objection.
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Mrs. Bono Mack. I thank the gentleman. And we also have
statements from members who are not on the subcommittee that
will be submitted for the record without objection.
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Mrs. Bono Mack. I just wanted to say that as we wrap things
up today, I want to thank all of our panelists as well as my
colleagues and their staffs for their time and their commitment
to this critically important issue.
If 30,000 Americans died every year from food poisoning,
Congress would take action. If 30,000 Americans died from
pesticide exposure, Congress would take action. And if 30,000
Americans died in airplane crashes every year, trust me,
Congress would take action in a huge way. So why are the
victims of prescription drug abuse treated differently? I don't
have an answer, but I encourage everyone here to help us find
one.
I remind members that they have 10 business days to submit
questions for the record, and I ask the witnesses to please
respond promptly to any questions they receive. Again, I thank
you all and I look forward to our work together in the future.
The subcommittee hearing is now adjourned.
[Whereupon, at 12:35 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]

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