<DOC>
[109th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:35338.wais]
PRESCRIPTION DRUG ABUSE: WHAT IS BEING DONE TO ADDRESS THIS NEW DRUG
EPIDEMIC?
=======================================================================
HEARING
before the
SUBCOMMITTEE ON CRIMINAL JUSTICE,
DRUG POLICY, AND HUMAN RESOURCES
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
JULY 26, 2006
__________
Serial No. 109-237
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
http://www.house.gov/reform
______
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California
DAN BURTON, Indiana TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee DIANE E. WATSON, California
CANDICE S. MILLER, Michigan STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California LINDA T. SANCHEZ, California
JON C. PORTER, Nevada C.A. DUTCH RUPPERSBERGER, Maryland
KENNY MARCHANT, Texas BRIAN HIGGINS, New York
LYNN A. WESTMORELAND, Georgia ELEANOR HOLMES NORTON, District of
PATRICK T. McHENRY, North Carolina Columbia
CHARLES W. DENT, Pennsylvania ------
VIRGINIA FOXX, North Carolina BERNARD SANDERS, Vermont
JEAN SCHMIDT, Ohio (Independent)
BRAIN P. BILBRAY, California
David Marin, Staff Director
Lawrence Halloran, Deputy Staff Director
Teresa Austin, Chief Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
MARK E. SOUDER, Indiana, Chairman
PATRICK T. McHenry, North Carolina ELIJAH E. CUMMINGS, Maryland
DAN BURTON, Indiana BERNARD SANDERS, Vermont
JOHN L. MICA, Florida DANNY K. DAVIS, Illinois
GIL GUTKNECHT, Minnesota DIANE E. WATSON, California
STEVEN C. LaTOURETTE, Ohio LINDA T. SANCHEZ, California
CHRIS CANNON, Utah C.A. DUTCH RUPPERSBERGER, Maryland
CANDICE S. MILLER, Michigan MAJOR R. OWENS, New York
VIRGINIA FOXX, North Carolina ELEANOR HOLMES NORTON, District of
JEAN SCHMIDT, Ohio Columbia
Ex Officio
TOM DAVIS, Virginia HENRY A. WAXMAN, California
Marc Wheat, Staff Director
Michell Gress, Counsel
William Collum, Acting Clerk
Tony Haywood, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on July 26, 2006.................................... 1
Statement of:
Fetko, Misty, registered nurse, who lost her 18-year-old son
Carl to DXM and Fetanyl abuse; Linda Surks, who lost her
19-year-old son Jason to a prescription drug overdose-
related death; Barbara van Rooyan, who lost her 24-year-old
son Patrick to oxycontin use; Mathea Falco, J.D.,
president, Drug Strategies; Stephen E. Johnson, executive
director, commercial planning, Pain Therapeutics, Inc.;
Laxmaiah Manchikanti, M.D., chief executive officer,
American Society for Interventional Pain Physicians; and
Steve Pasierb, president and CEO, the Partnership for a
Drug-Free America.......................................... 82
Falco, Mathea............................................ 101
Fetko, Misty............................................. 82
Johnson, Stephen E....................................... 127
Manchikanti, Laxmaiah.................................... 140
Pasierb, Steve........................................... 168
Surks, Linda............................................. 88
Van Rooyan, Barbara...................................... 93
Madras, Dr. Bertha K., Deputy Director for Demand Reduction
at the White House Office of National Drug Control Policy;
Dr. Sandra Kweder, Deputy Director in the Office of New
Drugs, Center for Drug Evaluation and Review at the Food
and Drug Administration; Joe Rannazzisi, Deputy Assistant
Administrator for the Office of DIversion Control in the
Drug Enforcement Administration; and Dr. Nora D. Volkow,
Director of the National Institute on Drug Abuse........... 11
Kweder, Sandra........................................... 44
Madras, Dr. Bertha K..................................... 11
Rannazzisi, Joe.......................................... 59
Volkow, Nora D........................................... 27
Letters, statements, etc., submitted for the record by:
Falco, Mathea, J.D., president, Drug Strategies, prepared
statement of............................................... 103
Fetko, Misty, registered nurse, who lost her 18-year-old son
Carl to DXM and Fetanyl abuse, prepared statement of....... 85
Johnson, Stephen E., executive director, commercial planning,
Pain Therapeutics, Inc., prepared statement of............. 130
Kweder, Dr. Sandra, Deputy Director in the Office of New
Drugs, Center for Drug Evaluation and Review at the Food
and Drug Administration, prepared statement of............. 46
Madras, Dr. Bertha K., Deputy Director for Demand Reduction
at the White House Office of National Drug Control Policy,
prepared statement of...................................... 13
Manchikanti, Laxmaiah, M.D., chief executive officer,
American Society for Interventional Pain Physicians,
prepared statement of...................................... 142
Pasierb, Steve, president and CEO, the Partnership for a
Drug-Free America, prepared statement of................... 171
Rannazzisi, Joe, Deputy Assistant Administrator for the
Office of DIversion Control in the Drug Enforcement
Administration, prepared statement of...................... 61
Souder, Hon. Mark E., a Representative in Congress from the
State of Indiana, prepared statement of.................... 5
Surks, Linda, who lost her 19-year-old son Jason to a
prescription drug overdose-related death, prepared
statement of............................................... 90
Van Rooyan, Barbara, who lost her 24-year-old son Patrick to
oxycontin use, prepared statement of....................... 95
Volkow, Dr. Nora D., Director of the National Institute on
Drug Abuse, prepared statement of.......................... 29
PRESCRIPTION DRUG ABUSE: WHAT IS BEING DONE TO ADDRESS THIS NEW DRUG
EPIDEMIC?
----------
WEDNESDAY, JULY 26, 2006
House of Representatives,
Subcommittee on Criminal Justice, Drug Policy, and
Human Resources,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 9:30 a.m., in
room 2154, Rayburn House Office Building, Hon. Mark E. Souder
(chairman of the subcommittee) presiding.
Present: Representatives Souder, McHenry, Foxx, Cummings,
Watson, and Norton.
Staff present: Marc Wheat, staff director and chief
counsel; Michelle Gress, Dennis Kilcoyne, and Jim Kaiser,
counsels; Scott Springer and Mark Fedor, congressional fellows;
William Collum, acting clerk; Tony Haywood, minority counsel;
and Cecelia Morton, minority office manager.
Mr. Souder. The subcommittee will come to order. Good
morning and thank you for being here today.
This hearing addresses a very important aspect of drug
abuse in our country and one that I do not believe is getting
enough attention, and that is a nonmedical use of prescription
drugs, a form of drug abuse. This somewhat quiet form of drug
abuse today is so common it is exceeded in prevalence only by
marijuana use. Moreover, nonmedical use of prescription drugs
now supercedes marijuana as a pathway for initiates into this
underworld of drug abuse. It is a problem facilitated by ease
of access to the drugs and a perception that prescription drugs
are safe because these are FDA approved.
Nonetheless, the statistics about prescription drug abuse
are incredibly alarming. To start with, according to the most
recent household survey approximately 6 million people were
currently users of prescription drugs for nonmedical purposes.
Of the 6 millon people abusing prescription drugs, most of
them were abusing pain relievers such as OxyContin, 4.4
million.
The Drug Abuse Warning Network reported that 495,000
emergency room visits in 2004 related to the nonmedical use of
prescription drugs.
The most recent Monitoring the Future Survey, measuring
drug use amongst our Nation's adolescents, found high rates of
nonmedical use of prescription pain relievers in each of the
8th, 10th and 12-grade groups surveyed. The prevalence of
OxyContin use in particular has increased 40 percent since
2002.
The National Center on Addiction and Substance Abuse at
Columbia University, CASA, found that between 1992 and 2003 the
number of people abusing controlled prescription drugs
increased 94 percent, twice the percentage increase of people
using marijuana, five times the number of people abusing
cocaine, and 60 times the number of people abusing heroin.
CASA also found that teens who abuse controlled
prescription drugs are twice as likely to use alcohol, five
times more likely to use marijuana, 12 times more likely to use
heroin, 15 times more likely to use Ecstasy, and 21 times more
likely to use cocaine than teens who do not abuse prescription
drugs.
The most recent Attitude Tracking Study by the Partnership
for a Drug Fee America found that teen abuse of prescription
drugs stems from the ease of availability, the lack of stigma
associated with street drugs and the false belief that they are
safe to use.
I don't believe anyone can consider these very sobering
statistics and survey results without concluding that the abuse
of prescription drugs is a problem of epidemic proportions that
demand focused attention and aggressive action by both the
government and the private sectors.
One of the congressional initiatives for addressing the
problem targets the issue of obtaining controlled drugs over
the Internet without a prescription. H.R. 840, introduced by
Chairman Davis and Ranking Member Waxman, amends the Food, Drug
and Cosmetic Act to establish disclosure standards for Internet
pharmacies, prohibits Internet sites from selling or dispensing
prescription drugs solely on the basis of online
questionnaires, and provides additional authority for States to
take action against illegal Internet pharmacies.
I am interested in hearing from our administration
officials here today about the administration's work on the
prescription drug abuse problem, and I am interested in
concrete actions, not more general statements about, ``working
closely with other agencies encouraging solutions to the
problem or,'' ``developing action plans,'' to address this
issue. I am tired of the empty rhetoric and long delays on
important matters like this and let me give you an example.
As part of a hearing on November 18, 2004, I asked the DEA
a number of questions regarding methamphetamine abuse. I just
received the responses to these questions last month on June
27, 2006. It took DEA 20 months to respond. That is an
unreasonable delay in providing crucial information to Congress
about methamphetamine abuse.
Moreover, it took the administration almost 2 years after
releasing its synthetic drug action plan in October 2004 to
come up with what it calls a synthetic drug strategy despite
repeated calls from Congress and only after Congress had passed
a bill on the subject, the Combat Meth Act.
Despite being 20 months in the making, this strategy is
full of platitudes that don't seem to be truly backed up with
any assigned responsibility or interim goals prior to the end
of this administration.
I don't want to hear platitudes today. I hope the
administration witnesses are listening closely to me right now.
I want the ONDCP to tell us what it means in terms of concrete
steps when it says it is going to call together representatives
from the medical and pharmaceutical communities to, ``discuss
the problem and to encourage them to educate patients.'' What
does ONDCP mean in terms of concrete steps with its
recommendations to ``continue to support the efforts of firms
that manufacture frequently diverted pharmaceutical products to
reformulate their products so as to reduce diversion and
abuse.''
I want to know if the FDA has responded to Congress' year
old request for a report on how the agency might handle
priority review of abuse resistant formulations of prescription
controlled drugs. This report was requested with the FDA
appropriations bill last year. Where is it? Why hasn't the FDA
provided guidance on this important matter? I am asking FDA to
provide this report to Congress and to provide specific
legislative recommendations for the reauthorization of this
Prescription Drug User Fee Act that will provide incentives for
developing and allow for accelerated approval of abuse
resistant forms of highly abused drugs. Since the Prescription
Drug User Fee Act is important to the FDA's bottom line, I will
expect the FDA to provide this information promptly.
I want to know what the DEA really means when it says it
is, ``working closely with the FDA to urge the rapid
reformulation of OxyContin.'' My staff has asked DEA officials
about this on at least two occasions over the last 12 months
and DEA could not provide the staff with anything concrete
about its statement. I want to know the bar. I want to know
what bar the DEA would set for categorizing controlled drug
reformulation as abuse resistant.
I know the National Institute on Drug Abuse has devoted
significant resources to studying this problem. I want to know
what the institute's research is showing about prescription
drug abuse and treatment and how we can apply this research to
overcoming this tremendous problem.
Despite what has become a standard practice here, I
challenge the administration witnesses today to stay for the
second panel and listen to the testimony that will be
presented. I know that means you have to stay for the entire
hearing so you can hear the testimony of witnesses other than
the government officials, but I think it would be helpful. I
think it would do some good for you to hear from the people who
have experienced the devastation of losing someone to
prescription drug abuse, to hear from one of the companies
actually working to develop drug abuse resistant forms of
pharmaceuticals, to hear from the organizations that are on the
front lines working to educate doctors, patients and kids or
partnering with the private industry to reduce prescription
drug abuse. The second panel gives a face to the problem and
presents solutions.
Our first panel today consists of Dr. Bertha Madras, Deputy
Director for Demand Reduction at the White House Office of
National Drug Control Policy; Dr. Sandra Kweder, Deputy
Director of the Office of New Drugs, Center for Drug Evaluation
and Review at the Food and Drug Administration; Mr. Joe
Rannazzisi, Deputy Assistant Administrator for the Office of
Diversion Control in the Drug Enforcement Administration; and
Dr. Nora Volkow, Director of the National Institute on Drug
Abuse.
Our second panel consists of Ms. Misty Fetko, a registered
nurse who lost her 18-year-old son Carl to Robitussin and
Fentanyl abuse; Ms. Linda Surks, who lost her 19-year-old son
to a prescription drug overdose related death; Ms. Barbara van
Rooyan, who lost her 24-year old son Patrick to OxyContin use;
Ms. Mathea Falco, president of Drug Strategies; Mr. Stephen
Johnson, executive director of Commercial Planning with Pain
Therapeutics, Inc.; Dr. Laxmaiah Manchikanti, chief executive
officer of the American Society of Interventional Pain
Physicians; and Mr. Steve Pasierb, president and CEO of the
Partnership for a Drug Free America.
I welcome each of you, and I look forward to your
testimony. I yield to the ranking member, Mr. Cummings.
[The prepared statement of Hon. Mark E. Souder follows:]
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Mr. Cummings. Thank you very much, Mr. Chairman, and I do
thank you for holding this hearing today. And as you were
speaking, I could not help but be reminded of so many years ago
when I was a high school student working in a pharmacy in south
Baltimore when people would come in to the neighborhood and buy
high volumes of Robitussin. And even back then it was a problem
and I shall never forget at 17 trying to figure out why would
anybody want to come and buy 10 or 15 bottles of Robitussin in
the middle of July.
So this problem is not a new one. The abuse and illegal
diversion of prescription drugs is not new, but due to a number
of factors it has been increasingly prevalent.
A number of factors have been cited by the National
Institute on Drug Abuse and others as contributing to the
expansion of nonmedical use of pharmaceuticals. These factors
include the growing number of drugs being marketed to treat a
seemingly ever expanding list of treatable illnesses and
conditions; increasingly easy access to pharmaceuticals by way
of use of the Internet, including from on-line pharmacies that
do not require a prescription and do not verify the identity of
the buyers; the relatively low stigma associated with
nonmedical use of prescription drugs versus the use of elicit
substances; and the common misperception that pharmaceutical
drugs are not dangerous.
As I have said many times, the person who improperly uses
prescription drugs and abuses them is just as bad and puts
themselves in just as much danger as a person who was sitting
in a corner snorting cocaine.
The fact is that any drug can be dangerous when used in the
absence of appropriate medical evaluation, guidance and
supervision.
This is why the recent estimate that some 43 million
Americans have used prescription drugs for nonmedical purposes
is so very, very disturbing.
Moreover, 2004 National Household Survey of Drugs and
Alcohol indicated that 6.3 million Americans, 12 years of age
or older, reported nonmedical use of prescription drugs in
2003.
Data suggested that the elderly, young adults between the
ages of 18 and 25, and young women between the ages of 12 and
17 may be particularly at risk.
Perhaps recent trends of the abuse of DXM, an ingredient
found in over-the-counter cough suppressant medicines and
Fentanyl, another opiate, have also caused great concern.
Reports indicate that the latter drug is used sometimes
unknowingly in conjunction with heroin and it has been linked
to numerous overdose death in cities across the country.
Sadly, we will hear testimony from three mothers of sons
whose lives were lost as a result of prescription drug abuse.
They represent a tiny fraction of the universe of people
who have lost loved ones to prescription drugs, and their
compelling testimony will help us understand how this problem
plays out in individual cases.
Hopefully, it will also serve as a stark warning to the
public that abuse of prescription drugs is, in fact, dangerous.
I think it is clear, Mr. Chairman, the problem warrants a
multi-faceted response, and I would like to see Congress and
the administration pursue the following actions. And before I
go into that list, I agree with you, Chairman Souder, so often
we have a motion come and no results.
And then we come later on, 10 years from now, we are
dealing with the same problems. More people have suffered, more
have died and more have abused these prescription drugs.
So in the light of trying to get something done and push
this ball down the field, I would suggest that we enact
legislation to require that every on-line purchase of a
prescription drug involves a valid prescription and
verification of the purchaser's identity, that we provide
Federal funding to support prescription monitoring programs in
the States, that we support and promote efforts to educate the
public, the medical community and pharmacists about the risk of
prescription drug abuse and diversion, we encourage efforts to
develop drug invasions that are non-resistant and addictive to
abuse, and we encourage all parties involved in the drug supply
chain and the consumer purchase transactions to take steps to
prevent illegal diversion of pharmaceutical products.
Granted, some of these measures may be more complex than
they may sound at first blush. The devil always lies in the
details. But I am confident that we can summon the will to
overcome whatever obstacles there may be to moving forward on
all these fronts.
Certainly today's hearing offers a valuable opportunity to
hear recommendations from a variety of different viewpoints
concerning how the Federal Government should approach these
tasks.
As I close, Mr. Chairman, I cannot help but think about the
many people that came into that south Baltimore drugstore. Many
of them a little older than I was back then but many of them
are dead. With that said, Mr. Chairman, I want to close by
extending my deepest sympathies to our witnesses who have lost
a child to prescription drug abuse and by applauding all of our
witnesses for their work. They are going to address this issue.
I think we can all agree that more must be done. The question
is whether we will have the will and whether we will do it.
With that, Mr. Chairman, I yield back and thank you.
Mr. Souder. Thank you. I ask unanimous consent that all
Members have 5 legislative days to submit questions and answers
for the hearing record. Any answers to written questions
provided by the witnesses also will be included in the record.
Without objection, so ordered.
I also ask consent that all exhibits, documents and other
materials referred to by witnesses may be included in the
hearing record, that all Members be admitted to revise their
statements. Without objection, so ordered.
Under the House rules, we will have to adjourn for Iraq's
Prime Minister. Our intention is to get through the first panel
and then we may have to suspend if we do not get into the
second panel before we need to suspend. I intend to reconvene
the hearing at 12 promptly, which should give us time to have
completed the Prime Minister's address.
With that, I thank each of the witnesses for coming and
first I need to swear everybody in. If you would just raise
your right hands. We will do it sitting. It is our standard
practice to swear in our witnesses.
Let the record show that each of the witnesses responded in
the affirmative, and we will start with Dr. Madras. Thank you
for coming here.
[Witnesses sworn.]
STATEMENTS OF DR. BERTHA K. MADRAS, DEPUTY DIRECTOR FOR DEMAND
REDUCTION AT THE WHITE HOUSE OFFICE OF NATIONAL DRUG CONTROL
POLICY; DR. SANDRA KWEDER, DEPUTY DIRECTOR IN THE OFFICE OF NEW
DRUGS, CENTER FOR DRUG EVALUATION AND REVIEW AT THE FOOD AND
DRUG ADMINISTRATION; JOE RANNAZZISI, DEPUTY ASSISTANT
ADMINISTRATOR FOR THE OFFICE OF DIVERSION CONTROL IN THE DRUG
ENFORCEMENT ADMINISTRATION; AND DR. NORA D. VOLKOW, DIRECTOR OF
THE NATIONAL INSTITUTE ON DRUG ABUSE
STATEMENT OF BERTHA K. MADRAS
Ms. Madras. Chairman Souder, Ranking Member Cummings, and
members of the subcommittee. Thank you for the invitation to
testify before you today regarding the abuse of prescription
drugs. The abuse, sometimes called nonmedical use of
prescription drugs, is a significant national problem. In sheer
number of users it is now America's No. 2 drug problem, second
only to marijuana.
Last year the National Survey on Drug Use and Health
indicated more new initiates of nonmedical prescription drug
use than of marijuana.
Opiates, pain killers like OxyContin, stimulants like
Ritalin, and sedative sleeping aids such as Ambien are examples
of prescription drugs which are legal and beneficial when
lawfully used as indicated. They nevertheless have potential
for abuse and for addiction.
The administration's response to this problem strives to
balance two important policy concerns: First, that prescription
drugs have strong medical benefits when used lawfully and in
accordance with medical direction; second, these same drugs can
be harmful, even deadly, when abused. And the rate of abuse is
growing rapidly.
The administration has set an objective of reducing
prescription drug abuse by 15 percent over the next 3 years.
The Synthetic Drug Control Strategy released last month
describes the administration's plan to accomplish this
ambitious goal. To reduce those illicit supply of prescription
drugs, traditional law enforcement and interdiction activities,
including at our border, are important and an additional
element for this class of drugs is regulatory. For example, the
administration strongly supports State run prescription drug
monitoring programs which seek to reduce doctor shopping,
prescription fraud, and ultimately diversion opportunities
through State level regulation designed to improve the sharing
of prescription information between prescribers and dispenser.
At the beginning of the President's term, there were
approximately 15 of these programs. Now there are 33 States
where programs exist or have been authorized and the
administration hopes to see a prescription drug monitoring
program in every State by the end of the President's second
term.
The administration is also focused on reducing other
avenues for diversion. Federal law enforcement targets both
rogue Internet pharmacies and the very small percentage of
physicians who circumvent law and sound medical practice to
violate certain medical provisions for nonmedical reasons.
Preventions for treatment are strong for our strategy. Public
health messages, the identification of prescription drug
abusers and treatment capacity are major components of the
synthetic strategy.
The administration is concerned about the sharing of
prescription drugs among family and friends. Our strategy
involves a partnership with the pharmaceutical and medical
communities to educate Americans as to the importance of
monitoring, disposing of unneeded, unused medications.
We are holding a medical education conference in December
in which we are inviting the deans of major medical schools as
well as State medical boards in order to educate them on this
issue. The theme of this medical conference is in fact
prescription drugs.
We are also holding a conference this Friday on physician
control in which we bring together a multidisciplinary task
force of researchers, policemen, medical examiners and
treatment providers to educate them in the problem of potential
associated death. In Philadelphia, which is a State that has
had a very high rate of often continual associated deaths, the
National Youth Anti-Drug Media Campaign launched an open letter
in People Magazine last Friday encouraging parents to be aware
of the number of people abusing prescriptions and other drugs.
This letter to parents will run in numerous other publications
in the near future and a copy of it is on exhibit to the right
in this room.
Drug Free Communities is working on prescription drugs and
other educational and teaching materials in over 365 of these
communities.
Programs and initiatives which are not drug specific are
also important tools in reducing this public health problem.
Random student drug testing can help screen young people for
prescription drug abuse and offer positive appropriate
counseling. The screening brief intervention referral to
treatment programs is a key component of expanding our capacity
to identify, counsel and refer to treatment persons with
substance abuse disorders. It identifies a cohort of
prescription drug abusers who enter hospitals or clinical
environments seeking treatment for reasons other than
prescription drugs. federally supported treatment programs such
as the Access to Recovery and Drug Courts can help heal those
addicted to prescription drugs.
To achieve a 15 percent reduction in prescription drug
abuse we need to increase public awareness and collaboration
with the medical community, the pharmaceutical community, all
of the risks associated with nonmedical use of prescription
drugs. And we have concrete plans to further this goal.
Toward this end, I thank Congress for its support of both
the President's National Drug Control Strategy and Synthetic
Drug Control Strategy.
[The prepared statement of Ms. Madras follows:]
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Mr. Souder. Thank you.
Dr. Volkow.
STATEMENT OF NORA D. VOLKOW, M.D.
Dr. Volkow. Good morning, Mr. Chairman, Mr. Souder and Mr.
Cummings and other members of the committee. It is a privilege
for me to be here to discuss the science behind the abuse of
prescription medication.
We heard the problem is quite large; 6.3 million Americans
have used prescription medication. We have also heard that it
has surpassed prescription medication, surpassed in terms of
2004 the number of new initiates over that. This is the first
time this has happened. If you look at Monitor the Future,
which surveys 8th, 10th, 12th graders, prescription medication
is No. 2 just preceded by marijuana, but No, 3, No. 4, No. 6 in
terms of prevalent are also prescription drug medications. So
prescription medication abuse is widespread.
What are the prescription drugs that are abused? They are
three classes: Pain medications, that's opiates or OxyContin
and Vicodin, which are typically used to treat severe or
moderate pain; stimulant medication such as amphetamine and
Ritalin, which are typically used to treat attention deficit
disorders; and sedative hypnotics, such as benzodiazepines and
barbituates like Lithium and Valium which are typically used to
treat sleeping disorders, anxiety, and muscle spasms.
Why are they abused? They are abused because like illicit
drugs, like meth or cocaine, they increase the concentration of
the chemical dopamine in required areas of the brain. And they
use the same targets that some of these drugs use. For example,
Ritalin and amphetamine stimulant use the same targets as
cocaine and meth respectively. For the opiates, OxyContin,
Vicodin, Hydrocodone use the same targets as morphine, and
benzodiazepines use similar targets as alcohol.
So the question is what is the difference between these
drugs being therapeutically effective and the potential of
abuse? And what we have learned is that there are several
factors, but there are two key factors. One of them is dose.
When these drugs are abused, they are used at much larger doses
and the doses are taken much more frequently than when
prescribed therapeutically.
Another important factor is the route of administration.
When you take drugs that are for their therapeutic reasons,
they are given orally. When they are abused, they are snorted
or injected. And why is that so? Because what we have learned
is for this type of drug to be rewarded, they have to get into
the brain very rapidly and the route of administration affects
the rate at which these drugs enter. When they are injected or
snorted, they go into the brain much more rapidly than they
when they are taken orally.
Who is at risk? Well, this is nondiscriminatory. It affects
all ages or genders or socioeconomic classes. It has phases,
for example, for the first time with the abuse of opiate
individuals. Now lessons which--usually in terms of opiates
abuse, heroin abusers are in their 20's or 30's or 40's. This
is particularly problematic because the brain is still
maturing. So at this stage the abuse of these medications can
affect the proper development of the brain making these
individuals more vulnerable to the addictive effects of other
drugs into the future.
What do we know about why is this happening now? Some of
these factors have been mentioned. There has been a dramatic
increase in the number of prescriptions for these medications.
Stimulant, the rate of prescriptions have basically doubled
every 5 years over the past 15 years. The rate of production
has escalated. There has been increased advertisement of these
drugs in the media. We have easy access to the Internet. We
have generated a culture that not only gives medications for
the treatment of disease, but has started to give medications
to improve performance. And those that believe that it may be
safe to take this prescription drug because, as was mentioned
before, they are approved by the FDA; unfortunately, the recent
reminder of the deaths from the use of the Fentanyl is a
reminder that these drugs are very dangerous.
So what is NIDA doing? NIDA has taken a multi-pronged
approach to invest research into the basic neuroscience of what
are these drugs doing to the brain. What are the genes that
make a person more vulnerable? What is the etiology?
Environmental? We are also developing medications that are
potent analgesics without having the resultant properties. We
are delivering new ways so they can minimize the abuse. At the
same time, we are developing treatments to actually deal with a
problem of the person that is addicted to prescription
medication and to target those individuals that need the
medication but become addicted.
Finally, we realize the importance of education and with
partners with SAMSHA and with all medical professional
communities to educate both the clinicians as well as the
public about, yes, the therapeutic volume of the medication but
also the importance of proper surveillance.
I thank the committee. This is a problem that has not been
given the attention that it deserves. It is urgent. And it is a
privilege for me to be able to share with you how science can
help with it.
[The prepared statement of Dr. Volkow follows:]
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Mr. Souder. Thank you.
Dr. Kweder.
STATEMENT OF SANDRA L. KWEDER, M.D.
Dr. Kweder. Good morning, Mr. Chairman. My name is Sandra
Kweder. I am the Deputy Director of the Office of New Drugs and
the Center for Drug Evaluation and Research. I appreciate the
opportunity to talk about our drug approval process and it's
interface with our role in preventing prescription drug abuse.
FDA is a public health agency that is strongly committed to
promoting and protecting the public health by assuring that
safe and effective products reach the market in a timely way
and that the products are marketed for continued safety once
out there.
The FDA is aware of and is concerned about reports of and
the reality of prescription drug abuse, misuse and diversion.
We are aware of data showing that abuse of prescription drugs,
including narcotics, is growing.
This is a serious issue and we sympathize with the families
and friends of individuals who have lost their lives or
otherwise have been harmed as a result of prescription drug
abuse and misuse. We have them, too.
While addressing the important issues of drug abuse and
misuse, FDA must assure that patients who require these
medicines maintain appropriate access to them through informed
providers and safeguards.
Under the Food, Drug and Cosmetic Act, FDA is responsible
for ensuring that new drugs are safe and effective. Before any
drug is approved for marketing in the United States, FDA must
decide whether the studies and information submitted by the
drug sponsor have demonstrated that the drug is safe and
effective when used according to the drug's labeling.
When the drug's benefits outweigh the risks and the
labeling instructions and some certain other measures allow for
safe and effective use by patients, FDA approves the drugs for
marketing. Let me say a little bit more about what I mean by
other measures.
At the time of approval and sometimes after approval, FDA
may develop in cooperation with the drug sponsor a plan of
interventions beyond labeling to help assure the safe and
effective use of the drug. This has been referred to as risk
management plans or risk maps, but the practice dates back many
years.
Interventions that might make up a risk management plan
vary, but all are aimed at assuring that known or potential
issues regarding proper use of the drug are addressed by
prescribers and patients. The agencies' expectation for
developing risk maps, including aspects that might include
post-marketing surveillance and other strategies, are detailed
in a set of guidances that we published in March 2005 as a
response to reauthorization of the Prescription Drug User Fee
Act.
The provisions of the Controlled Substances Act are a means
of actually managing risk of drugs, although they predate this
term of risk management plan or risk map. Under the CSA, we at
FDA notify the DEA if a new drug application is submitted for
any drug having a stimulant, depressant or hallucinogenic
effect on the central nervous system. That would include
opiates because it is assumed that the drug may have abuse
potential. For such drugs, the products' developer or sponsor
must provide FDA with all data pertinent to abuse of the drug,
a proposal for scheduling under the CSA, and data on overdoses.
We then represent a scheduling category, but DEA makes the
final scheduling category decision.
In addition to scheduling, it is common though for products
with abuse potential to have risk maps that establish
interventions to actually prevent misuse, abuse and overdose.
Specifically, FDA expects sponsors of applications for any new
drug with abuse potential to submit a risk map to address three
important areas: Preventing accidental overdose, ensuring
proper patient selection for prescription, and preventing
misuse and abuse. And we review those proposals very carefully.
While individual programs will vary based on product
specific considerations, every risk map for drugs with abuse
potential should address those three elements and contain
monitoring plans above and beyond the usual for side effects.
Specifically to identify misuse, overdose, abuse or potential
for diversion. Examples might include specialized training for
providers, call centers, or Web sites for reporting problems or
obtaining advice, single source distribution, kits for patients
to ensure safe storage and disposal, limited marketing roll out
plans, targeted surveillance activities to detect excessive
prescribing or prescription diversion and additional studies to
address development of novel formulations.
Our job is not over after approval. We work diligently to
assure that these programs are adhered to and changed if
necessary. We monitor our own adverse reactions reporting
system for signals of side effects that might suggest abuse or
misuse, and we also utilize the DAWN system that SAMSHA
operates to continually reasses drug use in the area of abuse.
We work deliberately with the DEA and other agencies. We
meet regularly to work on projects to prevent diversion,
develop programs for physician education, collaborate with
State prescription drug monitoring programs and other task
forces. We recognize the serious problem of prescription drug
abuse and we are taking steps to address this serious problem.
In conclusion, we share the subcommittee's interest and
concerns regarding prescription drug abuse, and I'll be happy
to answer further questions.
[The prepared statement of Dr. Kweder follows:]
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Mr. Souder. Thank you.
Mr. Rannazzisi.
STATEMENT OF JOSEPH T. RANNAZZISI
Mr. Rannazzisi. Chairman Souder, Ranking Member Cummings.
On behalf of Administrator Tandy and the Drug Enforcement
Administration, I appreciate your invitation to testify today
regarding DEA's effort to address the efforts of prescription
drug abuse.
Addressing the growing problem of diversion and abuse of
controlled programs continues to be one of the top priorities
of the Drug Enforcement Administration. DEA has not remained
idle in response to this growing threat. DEA has significantly
increased the amount of resources and manpower dedicated to
investigating the diversion of controlled substances of
particular pharmaceuticals. We continue to focus our drug
enforcement efforts on the most significant diverter in the
drug supply chain. The illustration of the administration's
focus on this problem occurred on June 1, 2006, when the
Department of Justice along with DOE, DHS and HHS released the
Synthetic Drug Control Strategy, which among other threats
specifically targets prescription drug abuse.
The DEA is constantly aware of this problem and, as
outlined in that strategy, we have committed an ambitious goal
of reducing the abuse of controlled pharmaceuticals by 15
percent over the next 30 years. In developing the strategy to
attack this problem, it's important to understand that there
are distinct differences between drugs such as heroin,
marijuana, and controlled pharmaceuticals.
Typical drug control strategies used to attack
organizations that focus on distribution of clandestine drugs
do not necessarily lend themselves to attacking those
organizations that illegally traffic in illegal
pharmaceuticals. Distribution channels that are otherwise legal
are often manipulated to acquire controlled substance
prescription drugs for illegal purposes. Compounding this
matter is the perception, particularly among teenagers and
young adults, that controlled pharmaceuticals are safe even
when used recreationally.
The most common methods of diversion witnessed are through
doctor shopping, prescription fraud, improper prescribing and
sharing among family and friends. Perhaps the largest growth
method for controlled substances diversion is the Internet.
Looking at perhaps the most potentially dangerous and
increasingly used method for controlled substances, the
Internet, we have discovered that many of these on-line
pharmacies do not operate in the same manner as brick and
mortar pharmacies. This includes advertising controlled
substances for sale without a prescription and not requiring an
in-person medical examination by a licensed physician.
There are strong societal benefits to allow individuals
with a valid prescription to get their prescriptions over the
Internet as long as the pharmacy that fills the prescription is
legitimate and there exists a legitimate doctor-patient
relationship. There are legitimate pharmacies that provide
services over the Net and that operate well within the bounds
on both law and sound medical practice. However, what is
particularly troubling is the idea that a minor can easily log
on to an illicit Web site, provide an inaccurate age and have a
controlled substance delivered directly to their door.
No special DEA registration is currently required to market
controlled substances on-line, but the tangible aspects of
manufacturing, distributing, prescribing and dispensing
pharmaceuticals and controlled substances remain squarely under
the jurisdiction of the Controlled Substances Act. Any
legitimate transaction over the Internet must comply with these
laws.
Additional clarification by roles of responsibilities for
professionals seeking to use the Internet to meet the needs of
clients would not only allow us to more readily identify
legitimate on-line pharmacies and persons using them but would
also assist in gathering and pointing to abuse patterns.
In addition, there exists no statutory designation of a
doctor-patient relationship.
Finally, the potential of those associated with an illegal
sale of Schedule III through V substances, which are those most
often sold over the Internet, are not as significant as may be
warranted.
Finally, it is important to consider DEA's obligation under
the law and to the public, which is to ensure that controlled
substances are prescribed and dispensed only for legitimate
medical purpose and in accordance with the CSA. Understanding
the differences and the similarities between prescription drugs
and controlled substances is an important aspect of evaluating
the causes and policy solutions regarding the rise in
prescription drug abuse.
In conclusion, the diversion program of controlled
substance continues to be a significant challenge. Nevertheless
the DEA is committed to use the necessary tools at its disposal
to fight this problem on all fronts while simultaneously
ensuring an uninterrupted supply of pharmaceutical controlled
substances for legitimate demands.
Chairman Souder, Ranking Member Cummings, thank you again
for the opportunity to testify today. I'll be happy to answer
any of your questions. Thank you.
[The prepared statement of Mr. Rannazzisi follows:]
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Mr. Souder. Let me ask a basic question first. Maybe if Dr.
Volkow and maybe Mr. Rannazzisi will know the answer to this
question. In the overdose-misuse categories in particular, do
we know how many of these people have a legitimate prescription
and then move on to abusing it as opposed to just starting with
abuse?
Dr. Volkow. No. That information, to my knowledge, is not
accessible. One of the problems that happens in emergency rooms
where you are recording these numbers is that in general, I
mean the individual that comes in with an overdose, may not
necessarily state this was for diversion purposes and many
times they won't want to admit it. So the physicians don't even
have the information about what may be wrong with the
particular individual. So the numbers are not clear in terms of
what percentage constitutes the diversion versus proper
medication. It is likely that in most cases it will come from
diversion because if you are properly prescribing the
medications they have guidelines about how to instruct the
patients to ensure that they will take it safely. However,
there is a subgroup where that is a higher risk and that is
elderly individuals which may forget that they've taken their
medication or, on the other hand, may be taking multiple
medications and then combine them in an inappropriate way. So
that is the subgroup that is at risk for developing medical
complications even when properly prescribed.
But otherwise, I would predict the numbers are not there
just on the standard practices of medicine that when used
properly, these medications are quite safe.
Mr. Souder. Because that defines our problem substantially
different when you make certain assumptions. I mean if you have
small percentage who might decide to self-medicate, that the
treatment wasn't enough. You have seniors that you mentioned,
may be that case. But it leads to a whole different type of a
strategy depending on that data, and I would think gathering
that data becomes fairly critical here, if nothing else kind of
doing a post-analysis of people out of the emergency rooms
trying to figure out whether they in fact had legal
prescriptions and where they got it because that would seem
such a basic piece of information. Any background is business,
that is how you would approach it. You'd say what is my target
group and try to figure out where it came from.
Another related question to that is my understanding the
moral conflict. You said was that one of the big reasons people
do this is the way they need to inhale it to get it into the
brain faster. That suggested to me that if you are doing that,
that probably you weren't using it for--you didn't start with
that as a legitimate pain medication because that sounded more
like a recreational use question or perceived recreational use
question, and that means that the market and the strategy,
whether it's a treatment question, a prevention question, youth
education question, law enforcement question is substantially
different because we have people who really don't want to know
how to use it.
Therefore, my guess is, for example, ONDCP announcing a
conference, they are going to pull all of the manufacturers
together, may be in fact irrelevant because they already know
the dangers of the problem. The question is how do you in this
at risk market reach them? And let me ask a fundamental
question of Dr. Kweder.
Dr. Volkow. Can I answer you? Just one point. I want you to
be aware of this. This is something that struck me when I first
heard about it, which is I wanted exactly the same numbers.
What are the numbers on the emergency rooms that are accounting
for overdoses? I wanted those numbers badly. We couldn't get
them. Part of the problem is that many States, most of the
States, and in the emergency room, if someone comes in with an
illegal substance that they have taken for illegal purposes,
the insurance will not reimburse. So in the United States you
have a physician that wants to treat that particular
individual, you may not necessarily want to ask the question
because you are a physician who needs to take care of that
individual. So the rules themselves that we currently have in
emergency rooms do not necessarily help to be able to get an
idea of the problem.
Mr. Souder. Dr. Kweder, one of the requirements I mentioned
in my opening statement is from the Appropriations Committee is
you look at the abuse of recently formulated prescription
drugs. Do you believe you have the authority to grant priority
review for these products, and has it considered requests to do
so and, if so, have you granted priority review for any of the
types of products that in fact would make it more abuse
resistant?
Dr. Kweder. Mr. Chairman, the abuse--a product that came in
with a formulation that appeared to have any potential to
mitigate abuse potential would be something that we would
consider appropriate for a priority review. I don't know off
the top of my head which products we have granted such review
for, but I can provide that information.
Mr. Souder. But you believe you have granted some?
Dr. Kweder. I believe we have.
Mr. Souder. We would appreciate that soon for the record.
Mr. Rannazzisi, in this, the DEA has said in your
publication that you are working closely with FDA for rapid
reformulation of OxyContin. We have asked DEA about the
statements in the past and DEA hasn't provided us with any
response. I'll ask you again. Specifically, have you worked
closely with the FDA to urge this and what do you have to show
for your efforts of reformulation of OxyContin?
Mr. Rannazzisi. I can't specifically comment on OxyContin.
I can tell you that we work very closely with FDA on all
different issues regarding scheduling and new drugs. Our
scientists are continually in contact with them on all
different matters concerning the scheduling or new drug
approval process. The fact is that we have a special testing
lab in Virginia that would be able to take these formulations
and look at them and see if we could leach or remove the final
product from the tablets and we have offered that to
pharmaceutical companies in the past.
You know, abuse resistance, we could make a determination
in our labs if the product could be removed easily or with
difficulty and that information would be passed on to FDA. And,
again, that was offered to the companies. We do work closely
with FDA when it comes to that. We have to because that is how
we come up with what schedule the drug is going to be put into
and how it is going to be scheduled.
Mr. Souder. Here's what my frustration is. As mentioned in
the opening statement, of the 6 million people abusing
prescription drugs, 4.4 million were pain relievers such as
OxyContin. OxyContin in particular among youth is showing up 40
percent in the action plan to prevent the diversion and abuse
of OxyContin. It says DEA continues to work closely with the
Food and Drug Administration in strongly urging rapid
reformulation of OxyContin to the extent it is technically
possible in order to reduce abuse of this product, particularly
by injection. And the question is since this has been testimony
under oath and what your action plan is, what are you doing--I
mean, OxyContin is the major pressure point. Is anything
happening?
Mr. Rannazzisi. The key statement is to the extent it is
technically possible. The Drug Enforcement Administration does
not dictate how a company is going to formulate or reformulate.
Mr. Souder. I asked a more particular question. It says,
you said the agency, DEA, continues to work closely with the
FDA in strongly urging the rapid reformulation of OxyContin.
What I asked, my original question was what action points have
you had with FDA in the context to work with OxyContin? Not did
they find it. Did you ask them to find it? Do you have memos
you showed to ask them to find it? Has there been a task force
working to do it? Have they pulled it in? Have they tried to
reformulate two or three times and it didn't work? Is anybody
doing anything?
Mr. Rannazzisi. I'll have to get back to you on that, sir.
Mr. Souder. In your testimony you already said you were
doing it, in the testimony before. And your action plans. That
is--this is the major hearing. It's not like you got 10
hearings on this subject. It's not like this is a huge shock
that this question might come up. That is the frustration.
As you know, I've been a major supporter of DEA. I have
remained a major supporter of DEA. This type of thing is
frustrating. You can't make assertions and action plans that
you are doing something, then when you have your big hearing
that usually what happens is everybody scrambles after a 2-year
request to get it, and when the hearing finally comes we get an
answer and usually I am complaining that the answer came 1 hour
before the hearing. In this case, it still isn't here, and that
is what is frustrating. It's not like OxyContin--Fentanyl is
kind of a new one popping up on this, and we are trying to get
on Fentanyl, but on OxyContin it's not like we haven't had a
warning. Pharmacies are being robbed in my district. They have
been for a long time and all over the country, and we're saying
well, we will check out and see if we have done anything. That
is basically what my question was.
Ms. Madras. I wonder if I can march in here for a moment.
There is a manuscript that was published just a few weeks ago
by a Dr. Cohen on trying to define one of the problems of
formulations, and what he quotes is the number of Internet
sites that teach, instruct people how to circumvent effective
formulations. And for OxyContin, there are two or three
mechanisms that the Internet tells potential users how to get
around these. I do accept your view that this is a very
significant problem, but I think the program companies, which
take years and years to develop new formulations, are trying to
catch up to some of these strategies, and I think we have to--
--
Mr. Souder. You are telling me that multi-billion dollar
program companies, some of which happen to be in my home State,
and I am very proud of them with all of their buildings of
researchers, that kids and people can come up with multi-
reformulations and so they should just kind of say well, tough
luck. Kids are dying. That is kind of what you said that they
get--that I haven't had, and quite frankly the idea that the
Federal Government's big response here is that they read an
article about the difficulty of reformulations doesn't explain
are they trying. Have you asked them? What have they done? Are
you pushing them? Have they tried some reformulations and then
showed on the Internet they can get around those
reformulations?
That is what my question is. What actions have you done?
Not did you read an article, not did you wring your hands. I
understand it is difficult. When we try to stop trafficking of
the Internet, people are going to come up with a solution. That
is the business of crime, is to try to figure out how to get
around it. The question is do we say oh, well, I guess they are
going to get around anything we do so let's keep doing it the
way we are doing?
Ms. Madras. That is not.
Mr. Souder. So what are we doing?
Ms. Madras. Well, our goal is to develop a----
Mr. Souder. To have a conference.
Ms. Madras. No. A conference from my vantage requires an
action plan. And from our vantage what we are going to do is
have a consortium of program industries come together. SAMSHA
organized this a week ago and ONDCP has an intention to do this
as well. But without simply talking and devising strategies in
order to circumvent some of these obvious problems----
Mr. Souder. Mr. Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman. Dr.
Volkow, tell me something. Do you think we have an epidemic
here?
Dr. Volkow. I think we have an epidemic. I mean people get
caught up with the term ``epidemic,'' but I would just
determine this one and I think, as you mentioned, it is not a
new one. What is new, it was dramatic increases that are seen
in the opiate analgesics.
Mr. Cummings. You said something that struck me when you
were testifying. You were talking about the parts of the brain
that are affected by I guess overdosage of these prescription
drugs and, you know, I couldn't help and as I listen to
Chairman Souder I could not help but wonder about how powerful
these combinations are, this overdosage is. And the reason why
that is so significant to me is because thousands, literally
thousands upon thousands of inner city folks in my district are
sitting in jail for having possession of or distributing things
that I guess would be just as powerful as some of these
combinations. And it is interesting because you know, Mr.
Souder, Chairman Souder, said, I said it, I think all of us
said it, there is no stigma attached to this. The housewife
picks up the kids after school from the private school, then
dashes off to the ball in the evening.
When it's found that she is taking these dosages of
OxyContin, for example, there is no real--I mean a stigma.
Compared to the person who's shooting up dope in the alley in
Baltimore, he goes to jail; people just say ``poor little
Amy.''
And I guess what I'm trying to get to is, is there--the
combinations of drugs, the things that we're talking about, are
they just as powerful or can they be just as powerful as the
drugs like crack cocaine, heroin, methamphetamines, you know,
as far as damage to the body and mind?
Dr. Volkow. Well, very challenging question. And when used
properly, these drugs--with the prescribed doses and for the
purpose intended--these drugs are safe and very beneficial.
They can save people's lives. When they are abused, however,
they are utilized in very different circumstances. Some of
these drugs can be as damaging in terms of their addiction
potential as legal substances.
We've all heard about OxyContin. We've all heard about
fetanyl. Fentanyl is a potent opiate, it can produce addiction.
No difference of that in heroin in terms of the consequences of
overdose. It is as dangerous because you have a potent drug.
So these drugs, pharmacologically, when they are injected
pharmacologically, you cannot say this is worse than the other
one. In some instances, yes, there are some drugs that are as
potent, but some of these drugs can be as potent as the others,
and that is why that question comes around.
One of the important issues, though, which is very
challenging, we have people that even when properly prescribed
some of these medications for pain--and the numbers exactly we
don't know, precisely but it's between 5 and 7 percent of those
people with properly prescribed pain medications will become
addictive, following their physician. We are trying to
understand why. That chronic use of these drugs produces
changes in the brain that leads to the process of addiction, I
don't know yet.
Mr. Cummings. But you're talking 7 percent; is that what
you said?
Dr. Volkow. Five to 7 percent. We do not know exactly. I'm
very conservative, 5 to 7 percent.
Mr. Cummings. And that's one group, but that leaves 93
percent of others; is that right? If I'm doing my math right.
You said there is a group that may take these drugs
properly and may become addicted. There are others who go out
and make a choice; they make a choice to use these drugs the
way they are not supposed to be used. And I can understand
Chairman Souder's frustration, because basically what we have
is a group of people who make a choice to do this, and they
can, in many instances--just let me finish--skirt the law,
while that other person who goes and shoots up crack cocaine or
heroin can go to prison, but yet still they're--one is just as
dangerous as the other.
Dr. Volkow. You are absolutely right. As I said, there is
no justification of choosing to take that drug for a diversion
in some instances from other drugs. However, I do not believe
in stigmatizing the drug, whether it is a heroin addict or
whether it is an OxyContin addict. I think that what I believe
is important is to recognize this is a disease where that
individual, because of the effects of drugs, has lead to
changes that affect their behavior. And so I do not see
justification for stigmatizing the person that is addicted to
heroin as I don't see stigmatizing the person that is addicted
to OxyContin.
Mr. Cummings. But the fact is that in this country, if a
dope addict came in here right now on heroin, nodding, saliva
dripping from his face, as I've seen in my district, that
person is stigmatized as a bad person. I'm just telling you,
whether we like it or not.
So now the question becomes is, I do believe that education
is so significant in this because I think maybe a lot of times
people don't even realize what we just talked about, how--I
mean, they think I'll do a little here, a little something
here, and I'll add it and I'll get this buzz; and a lot of
times may not even realize the full impact of what is happening
to them. I mean, what do you see as the most practical
solutions?
Now, considering what I said in my testimony, that I was
dealing--I was looking at this problem as a 17-year-old, I'm 55
now, and being realistic of what this government will or will
not do, and we in the Congress, it is our job, as you well
know, to try and make policy to help protect the citizens of
this country. I mean, what would you have us do that you think
is practical and that you know can happen before we go to dance
with the angels?
Dr. Volkow. Well, to start with, I was delighted that you
organized this hearing. It's not that I need more work, but
I've been actually very proactive to try to make people aware
of the importance of this problem that, in my view, is not
recognized to the extent of the impact. So I spoke with the
FDA. I personally spoke with a doctor at NIH to alert him about
it.
So the notion of educating the different agencies is
extraordinarily important, like we're doing by this hearing;
it's a very important beginning.
In the process, also being coordinated. This is something
that we're not--again, it's not one agency by themselves; it
really needs that concerted effort of the multiple agencies.
And it does need the concerted effort of partnership with the
private industry because it's in their ultimate interest. They
don't want their OxyContin labeled as something that is
negative; it's bad for the reputation. So, taking advantage of
that to bring them into the process.
And it is really going to take, again, a systematic,
multiprong approach where, as we develop science, as we develop
programs which are in the FDA and for regulating, you have to
take that leadership position that bring this to the floor and
say we cannot ignore it, we need to address it, and we need do
address it and we need achievables, we need certain timeframes.
Mr. Cummings. In light of the time, Mr. Chairman, I yield
back.
Mr. Souder. Is this--is abuse of prescription drugs
disproportionate compared to others like heroin, cocaine?
Dr. Volkow. Yes. And I was mentioning that in terms of
monitoring the future, because when I saw the numbers, it's
very telling. You have, No. 1, 33 percent of kids, marijuana.
No. 2, it's Vicodin, 9.5 percent. No. 3 is amphetamine, 8.5
percent. No. 4 is--I think it's another opiate or a benzoate.
No. 5 is OxyContin at 4.5 percent. And then you have inhalants
and cocaine and prescription medications. So they are
overwhelming. And again, the notion of exposure to these drugs
which are very potent--and in this case most are taking them
not because they medically need it, but because of a diversion
situation is particularly vulnerable, because it can interfere
with the normal development; and what we know, it does make
early exposure to drugs, it makes the risk for addiction much
greater. So it's a very venerable period. So yes, those are the
numbers.
Mr. Souder. Ms. Watson.
Ms. Watson. I want to thank the chairman for his
responsible behavior because I see this as oversight, and we
don't do enough of this kind of oversight in Congress. And I
want to thank all of the witnesses here.
Dr. Volkow, since you seem to be the person that we're
targeting to give us some answers, you know as I've been
listening to your testimony, I'm thinking we are always dealing
after the fact and I don't hear enough in the front end about
prevention.
As I was reading the brochure on Jason Surks, he went on
the Internet and he was researching all these different new
medications and he thought he could use them without risk. Now
there is a memorial search center named after him.
The question is, What can we do to prevent young people
from looking outside of themselves to get a buzz on? Should we
do it through our schools or should we get our courts--you
know, we throw people into jail who we figure they're drug
users, drug sellers, and we're not doing a thing to
rehabilitate; in fact, lockups don't rehabilitate. But should
we, maybe throughout our county and your departments that are
represented here, maybe have walk-in drug abuse centers, both
prescription drugs and over-the-counter drugs? Should we
require across the educational spectrums--which is the only
mandatory program in this country--that we do a lot--starting
with K and going up the scale--to talk about the effect of
using these drugs on body functions and brain development?
And I'm really concerned about--I have a degree in school
psychology in my other life, and I saw the effects of drugs on
children. I tested them, and the result is poor performance in
school and, pretty soon, drop-out. So where do we go from here?
And any of you that have information, insight or vision, please
respond.
Dr. Volkow. Again, I am a strong believer of the importance
of prevention to tackle the problem of substance abuse and
addiction; in fact, it's our No. 1 priority, and we've been
doing research and prevention for many years.
What we've learned is yes, indeed, the educational system
is extraordinary to teach children and adolescents at different
stages of their life about the knowledge of what drugs can do,
but also teach them the skills that will enable them to
behaviorally be able to say no when they're in a peer-pressure
situation. And these programs have been shown to work.
At the same time, we've come to recognize that the aspect
of prevention--again, we need a multiprong approach, and we
should not just rely on the educational system, even though it
is very effective; we also need to involve the parents, we also
need to involve the medical community. As bizarre as it may
sound to you--because it sounded very bizarre to me when I
first heard about it--pediatricians don't necessarily evaluate
kids for abuse of substances. So the medical community, which
could play a very important role in the early detection of
abuse and substance abuse is not doing it. So this issue of
preventing drug abuse is a responsibility at multiple levels.
Now, definitely, we should take advantage of the education
system, but we also should alert--should involve the families
and the medical community into it.
Ms. Madras. I'd like to add to that.
As Dr. Volkow said, there are multiple means in which we
can educate young people through schools. Student drug testing
is an effective way, and we're been advocating and promoting
this program because it can provide children with an excuse for
not using drugs. Second, it can identify children who are using
drugs and steer them into counseling and into treatment if
necessary.
The second issue, as Dr. Volkow said, is parents. And our
media campaign is targeting parents, particularly in and
specifically with regard to prescription drugs, because we are
aware that parents have the No. 1 influence on children's drug
behavior.
The third issue which we are dealing with now with regard
to our medical conference that I would like to just add some
more detail is that we are profoundly concerned that the
majority of medical schools in this country, the majority of
residency training programs in this country, do not teach
physicians how to screen for drugs, how to screen for
adolescent drug abuse, and what to do once they screen for it.
So we have a two-pronged approach to trying to solve this
very significant void in medical education. No. 1 is to try to
enlist medical schools to develop these programs. And one of
the ways in which we can enlist medical schools to develop
these programs is to work toward reimbursing physicians for the
screening.
The second issue is, we are supporting programs throughout
the country in 14 States to conduct brief screening and
interventions in trauma centers and emergency rooms as well as
colleges, and we think that this program is an effective
mechanism for catching people who are using drugs and will be
identified by the medical community.
What is striking about the data that has emerged from
SAMSHA is that the number of people who are addicted, who do
not feel they have a problem, is a vast majority. It's
estimated between 70 and 90 percent of people addicted do not
come forward because they don't feel they have a problem. And
by screening people within the medical community--and most
Americans, more than 80 percent, see a physician at least once
every 2 years. By screening people in the medical community, we
will be able to identify and intervene and provide treatment
for them. I think this is one of the great voids that we can
fill that the administration and my office is working very,
very significantly toward.
Ms. Watson. Thank you.
This question goes to Dr. Kweder; is that the correct
pronunciation? You are the Deputy Director of the Office of New
Drugs Center for Drug Evaluation and Review at the Food and
Drug Administration. How about having an engagement from the
pharmaceutical manufacturers that when they put out a new drug
that has the potential of becoming an addictive kind or has
ingredients that the person using would become addicted to--and
there appears to be something in the American psyche that leads
them to using drugs; you know, you can't turn on your
television or your radio that they're not plugging something:
If you want to go to sleep, if you want to wake up, if you want
to stay awake, if you want to feel good, take this. So it goes
into our psyche. But how about talking to our pharmaceutical
companies about having a fund that the more profit they make
the more they add to that fund? Because I hear that after 9/11
the profits were astronomical for the pharmaceutical
manufacturers.
This fund, then, would support these walk-in counseling
centers. It wouldn't cost the consumer anything. But I would
think that the courts could direct people to those rather than
to lockups. And would you see the pharmaceutical manufacturers
engaging in that kind of thing? It's not a tax.
Dr. Kweder. The kinds of things that--we have not
specifically explored that as an option. What we have done is
we have looked at--when we evaluate drugs that have the
potential for abuse, we look at each one uniquely, to try and
ensure that the company is involved in activities that will do
everything possible to prevent diversion, to prevent overdose,
to prevent abuse. And we might use all kinds of measures. Those
might include limited marketing rollouts, for example, to
prevent that. They might include specific kinds of safety
measures or distribution systems that might prevent diversion.
For example, the only way for a hospital to obtain a
prescription drug would be directly from the company, without a
middle wholesaler or distributor. We have not specifically
explored with them a collaboration across companies to have
some sort of a fund.
I think another area that we might explore is how companies
can collaborate to look at tamper-resistant formulations.
Although we have participated in meetings and conferences
sponsored by the industry and by academia to do those things,
we have an example of a recent approval that was well out in
the press, where several companies got together to be able to
produce a formulation that would allow once-a-day
administration of three drugs to treat HIV. These are three
drugs that have been on the market by different companies for
over 10 years. Putting those together in one pill once a day
was a monumental effort, and it required all of the resources
of three very large pharmaceutical companies. But they did it
because they saw that there was an interest, and it's a huge
public health benefit. Those are the kinds of things, some of
the collaborations that we've been involved in with ONDCP, NIDA
and SAMSHA.
Ms. Watson. And this is my last comment, if I have----
Mr. Souder. We have to adjourn in 10 minutes.
Ms. Watson. Let me close it out.
I just to want say that if you could approach the
pharmaceutical manufacturers--and I notice now when they're
talking about a particular over-the-counter, a new prescription
drug, they do give the side effects, but it's always at the
last, at the end, and very quickly and very softly do they tell
you the side effects. Maybe if we played out the effect of this
medication on one's system, it might really garner that kind of
attention.
And thank you for the time, Mr. Chairman, and then I think
Dr. Kweder has a response.
Dr. Kweder. Thank you for saying that. We're actually doing
that. We have just implemented a new regulation that completely
changes the format of how information is presented both to
patients and providers so that the risk information, the key
information is right up front.
In recent approvals that we've had of drugs that have the
potential for abuse, we have also included in labels the kinds
of information about how to screen patients for evidence that
the drug may be being abused and how to address that once it is
detected, something that is really a departure from tradition
and I think is a real step forward.
Mr. Souder. Which is all nice, except that our testimony
said that the people we're talking about here are mostly
abusers of prescriptions, where people are getting the drug
illegally. Educating the doctors when they give us a
prescription, we have a whole different problem here--I'm not
saying it's not nice; this is not the major problem we're
addressing.
Ms. Foxx.
Ms. Foxx. Well, thank you, Mr. Chairman. You have led very
nicely into the comment that I wanted to make and the question
I wanted to ask.
I am very troubled by Dr. Volkow's comments that you do not
want to stigmatize anyone who is a drug abuser, and yet you're
saying that 70 to 90 percent of the people who are addicted to
drugs don't feel like they have a problem, and we want to spend
a lot of time educating young people about the problems of drug
abuse. It seems to me that you will never, ever get people to
believe that there is a drug problem if you don't stigmatize
drug abuse. And I cannot understand how you can say that it is
wrong to stigmatize people who abuse drugs. What is that saying
to the people who are trying to stop people from becoming drug
abusers? And I'd like to have a reaction to that.
And then I'd also like to know, do we have some sort of
composite study that's been done? I understand that there has
been--that compares programs that focus on personal
responsibility, such as the AA 12-step process and all these
other programs that just say to people, it's OK if you're a
drug abuser. So tell me what the results are in terms of
getting people off of--stop getting--getting people to stop
being drug abusers with those two programs, one that promotes
personal responsibility and the other that says it's perfectly
all right for you to be a drug abuser.
Dr. Volkow. Let me give you an explanation about why I do
not believe in stigmatization of the person who is addicted to
drugs. For the past 25 years of my life, never have I
encountered a drug-addicted person that wanted to be addicted.
The consequences of addiction to the person are devastating,
including suicide, loss of children, incarceration. I ask why
are you taking the drugs, and they say Doc, I don't even know;
it's no longer pleasurable, I just cannot control it.
Drug addiction is the result of changes in the brain of the
person that erode their ability to exert control. As a result
of that, even though they know that they shouldn't take the
drug, they don't want to take it, 24 hours later after being
released from prison--5 years, no drugs--they're taking it. It
is no longer a choice the way that we see it.
What is the problem of stigmatizing? What we're saying is
that it's a disease and it needs to be treated, and you need to
take responsibility over this disease. So by labeling it as a
medical disorder, we're not saying to the person it's OK, we're
not removing the responsibility; we're changing the framework,
we're highlighting the importance of treatment, both that
person needs help, and that the person needs to take
responsibility of that treatment.
As for your question, how effective are treatments? Drug
addiction can be treated, and some of the problems that you
mentioned that use 12-step bases like the Alcoholics Anonymous
are very beneficial for many drug-addicted people. They're not
a panacea, not everybody responds to it.
The other thing about drug addiction is it is a chronic
disease, which means that treatment would need to be
continuous, that you cannot just discontinue and expect a cure.
On the other hand, stigmatizing, what is the problem of
stigmatizing? The problem of stigmatizing is that the person
who is addicted to drugs is much more likely to recognize and
admit and stand up and say I need help because no one likes to
be stigmatized. So we have 85, 90 percent of people that are
addicted that are not seeking treatment. Part of the problem is
that the stigmatization can be difficult to overcome if you're
an addicted person that requires treatment. So we are not
helping anyone by stigmatizing.
This prevention, what we need is to educate children and
adolescents and the general population about the dangers of
drugs, the devastating consequences that drugs can have. That,
in my view, is what will make the change.
We did it with smoking in this country, we brought down
smoking by 50 percent. The moment we recognize and we mount a
multiprong approach to say we cannot afford this, this is just
too harmful to the person, too harmful to the society--we have
been successful with nicotine, not completely, we still have
significant numbers, but we have been successful, we need to do
the same thing for other drugs including prescription drug
abuse.
Ms. Foxx. Just a followup. You can call it a semantics
difference if you want to, but I think one of the reasons that
we brought down smoking is we've stigmatized smoking. You know,
there is just no other way around it, we have said it is bad
for you. If you call drug addiction a disease and people have
no control over it, I think you have just exactly the opposite
problem, and I think the statistics show that. It just is
incomprehensible to me that you cannot see the connection
between those two. And I know the chairman----
Mr. Souder. I need to go to Ms. Norton--are you done?
Ms. Foxx. Yes.
Mr. Souder. Ms. Norton.
Ms. Norton. Well, I just to want say that, unfortunately,
smoking worked because it shows that you die from cancer from
it. You didn't stigmatize people, you scared them into it, and
a new generation stopped smoking.
What you had to say was very instructive and I think very
well said about stigma; break through their disease and taking
responsibility for it. Your Alcoholics Anonymous is the best
example. The first thing you do is to get up and say, I am an
alcoholic and take responsibility for it, you admit it, and you
have been reached. And the real question is how to reach these
many Americans who--some of them are elderly and
unintentionally, apparently, becoming addicted--where the
addiction isn't even defined as such because they are taking
medicine; and thus when they begin to take more and more of it,
it may be very difficult to recognize that you have become
addicted to something the doctor prescribed. How can I be
addicted if the doctor prescribed this?
I'm not sure that the ordinary ways of going at addiction
are so very different when we're dealing with drugs and alcohol
that would work here. Is there a different way of reaching
people who are addicted to medicines that someone has said is
good for you and they just keep taking it without recognizing
that this has become an addiction? Is there a way to reach them
that has anything in common with the way we reach addicts, or
is this a different kind of addiction requiring a different
approach?
Dr. Volkow. Well, it has similarities and differences. And
I think you put the finger on one of the most complex issues,
how do we--and it is one of the ones that we're talking about
clinical trials--how do you treat the person that requires a
medication that becomes addicted to it? And more important, how
do you even recognize that person is addicted to it? And that's
one of the points that Dr. Madras brought out, the importance
of educating medical students as well as residents in their
specialty in recognizing the problem of substance abuse and
addiction, so that when they are prescribing these medications,
they can tell their patients there is a risk potential for
addiction with them, and these are the symptoms that you need
to watch, so that the individual themselves can recognize when
this is happening to them and alert the physician.
We don't have a standard yet, nor are we educating,
unfortunately, our medical students of the problem of drug
addiction, but bringing it to the medical community is of
extraordinary importance.
Ms. Norton. Shouldn't there be something on the label of
medicine that warns that addiction could result if this
medicine is taken beyond when it is prescribed?
Dr. Volkow. You, as a physician, when you're prescribing
this medication----
Ms. Norton. But I'm talking about the physician prescribes
it--you're speaking about the physicians who are rushed. If
there is something on the label cautioning people about trying
to get this prescription beyond when it is prescribed, and
saying that it could become addictive--people read those little
things that come with our prescriptions these days that are
very informative. Why not put that on it rather than trusting
some individual physicians--physicians may be very rushed and
in the process not always give the warning----
Mr. Souder. I'm sorry. The answer is going to be have to be
written. We have to suspend. The Prime Minister is in the
Chamber.
I think it is important to establish that earlier in the
hearing they testified that prescribed drugs going through a
doctor are not really a major problem here, it's more an
outside. But I don't think anybody disagrees that having some
kind of a label would be helpful for those cases, seniors and a
few others.
We are adjourned. We will reconvene at 12 o'clock promptly.
[Recess.]
Mr. Souder. The subcommittee will come to order. We thank
you for your patience.
First, I need to swear in the witnesses first. Our
witnesses on this panel are Misty Fetco, who is a registered
nurse who lost her 18-year-old son Carl to DXM and fentanyl
abuse; Linda Surks, who lost her 19-year-old son Jason to a
prescription drug overdose-related death; Barbara van Rooyan,
who lost her 24-year-old son Patrick to Oxycontin use; Mathea
Falco, who is president of Drug Strategies; Stephen Johnson,
executive director of commercial planning for Pain
Therapeutics, Inc.; Dr. Manchikanti, who is chief executive
officer of the American Society for Interventional Pain
Physicians; and Steve Pasierb, the president and CEO for the
Partnership for a Drug-Free America.
If you would each raise your right hands.
[Witnesses sworn.]
Mr. Souder. Let the record show that the witnesses
responded in the affirmative.
As an oversight committee, we always swear in our
witnesses. Ms. Fetco, you are sitting where Mark McGuire sat
and couldn't remember the past. I am hoping that you can today
and are willing to talk about it, because I think it is very
important that we learn from those experiences. Thank you for
being here today. And our sympathy goes out to all your
families. I know this is difficult, but we appreciate your
being willing to talk to the American people and to Congress
about the challenges you faced.
Ms. Fetko, if you want to go ahead.
STATEMENTS OF MISTY FETKO, REGISTERED NURSE, WHO LOST HER 18-
YEAR-OLD SON CARL TO DXM AND FETANYL ABUSE; LINDA SURKS, WHO
LOST HER 19-YEAR-OLD SON JASON TO A PRESCRIPTION DRUG OVERDOSE-
RELATED DEATH; BARBARA VAN ROOYAN, WHO LOST HER 24-YEAR-OLD SON
PATRICK TO OXYCONTIN USE; MATHEA FALCO, J.D., PRESIDENT, DRUG
STRATEGIES; STEPHEN E. JOHNSON, EXECUTIVE DIRECTOR, COMMERCIAL
PLANNING, PAIN THERAPEUTICS, INC.; LAXMAIAH MANCHIKANTI, M.D.,
CHIEF EXECUTIVE OFFICER, AMERICAN SOCIETY FOR INTERVENTIONAL
PAIN PHYSICIANS; AND STEVE PASIERB, PRESIDENT AND CEO, THE
PARTNERSHIP FOR A DRUG-FREE AMERICA
STATEMENT OF MISTY FETCO
Ms. Fetko. Good afternoon, Chairman Souder, Congressman
Cummings, and members of the committee. My name is Misty Fetko,
and I'm a registered nurse who works in a very busy emergency
room in central Ohio. But more importantly, I am a mother of
two wonderful boys.
I am here today to tell you the story of my oldest son
Carl. Carl was my beautiful boy, eyes like large dark
chocolates, an infectious smile and an insatiable curiosity. I
spent years protecting him from harm, but 3 years ago harm
found a way to sneak in and steal the life of this gifted young
man.
It was the morning of July 16, 2003. Carl had just
graduated from high school and was getting ready to leave for
Memphis College of Art in 2 days. The college had courted him
after he won an award for artwork he created in his junior year
in high school. The night before, Carl and I had sat in his
room and talked with each other about his day at work and the
pending trip to Memphis. He smiled and hugged me and said,
``Good night, Mom, I love you.''
The next morning I decided to walk the dog before waking
Carl. While walking next to his car I noticed an empty bottle
of Robitussin in Carl's back seat. Instantly I knew something
was wrong. I had been vigilant for signs of drug abuse in the
past and hadn't seen many. I rushed to his bedroom door, only
to find it locked. After finding my way in, I discovered Carl
lying peacefully in bed, motionless, with legs crossed, but he
wasn't responding to my screams and he wasn't breathing.
I quickly transformed from mother to nurse and began CPR,
desperately trying to breathe life back into my son. I could
not believe my worst fear was happening, my son was dead, but I
still did not know what had caused this nightmare.
We are a very close family and I am a very involved mother.
Carl always assured me that he wasn't using alcohol or drugs.
And I, the ever-watchful mother, believed him, as there really
wasn't any evidence to prove differently.
During Carl's junior year of high school, I found the first
evidence of marijuana in his room. After all the talks and
reassurances between us, what had changed? I intervened and
didn't see anything else suspicious until the summer after his
junior year, when I found two empty bottles of Robitussin in
our basement after a sleepover with friends. I was determined
to keep drugs out of our house; but cough medicine?
I went to search for answers on the Internet but found
nothing and confronted my son instead. Carl had explained that
he and his friends had experimented, but nothing had happened,
and I was reassured once again that he wasn't using hard drugs.
Finding no further evidence, I believed him.
During his senior year I knew Carl had developed an
interest for marijuana, but thought we had addressed it. So why
on that dreadful July morning did I discover that my son had
passed away during the night?
The next several months after Carl's death I frantically
searched for answers. During my search I found two more empty
bottles of cough syrup, but it wasn't until after talking with
friends and finding journal entries on his computer did I
discover that Carl had been abusing cough medicines
intermittently over the past 2\1/2\ years.
Through the Internet and his friends, Carl had researched
and educated himself on how to use these products to get high.
He read about and enjoyed the hallucinations achieved by
abusing cough and cold products. But I wouldn't find out until
the morning of Carl's death what he and many others knew about
his abuse of cough medicine. The danger that I so desperately
tried to keep out of our house had found a way to sneak in
secretly, but there were no needles, no powders, no smells,
none of the typical signs associated with drug abuse.
Carl's autopsy report revealed that he had died from a
lethal mix of drugs. Fentanyl, a strong prescription available
in a patch, cannaboids, found in marijuana, and DXM, the active
ingredient in cough medicines, were found in his system. To
this day, I don't know where Carl obtained the narcotic
fentanyl. There are no journal entries that talk about his use
of pain killers. Was this his first time? We will never know
why he made the choice to abuse prescription and over-the-
counter drugs; we only know parts of his story by the words he
left behind in his journal. His words are now silent.
I've spent many hours trying to find a reason for this
unexplainable tragedy. If loving my son were enough, Carl would
have lived forever. But I know now that the abuse of over-the-
counter and prescription drugs is rapidly emerging. Access to
information about this type of drug abuse is prevalent on the
Internet. Availability to obtain these drugs--which can be
lethal and abusive--is even more prevalent, but what is even
scarier is that these teens have a false sense of security;
they have the mindset that these drugs provide a safe high.
We as parents need to be aware of these lurking dangers,
and we need to make other parents and teens aware of them, too.
It is with a heavy heart and eternal love for my son that I
share his story today to hopefully prevent other families from
having to suffer the same heartache.
Thank you for calling this hearing today to examine the
problem of prescription drug abuse in our country. I appreciate
you listening, and I'll be happy to answer any questions.
Mr. Souder. I thank you for your willingness to testify. I
can see it's very difficult.
[The prepared statement of Ms. Fetko follows:]
[GRAPHIC] [TIFF OMITTED] T5338.056
[GRAPHIC] [TIFF OMITTED] T5338.057
[GRAPHIC] [TIFF OMITTED] T5338.058
Mr. Souder. Ms. Linda Surks, thank you for coming also.
STATEMENT OF LINDA SURKS
Ms. Surks. Thank you.
Good afternoon, Chairman Souder, Congressman Cummings, and
members of the committee. Thank you for holding this hearing
today to examine the problem of prescription drug abuse, a
subject which is very close to my heart.
My name is Linda Surks, and I'd like to tell you about my
son, Jason.
Jason was the kind of person that people were drawn to. He
made friends easily and had a great sense of humor. He was a
caring person and a loving son. He was active in his youth
group and participated in several community service projects.
He even volunteered at NCADD where I work, a community-based
organization in Middlesex County, New Jersey, that works to
prevent substance abuse.
When Jason was a little boy, he would lie about little
things; like the time he was 7 years old and he swore he had
taken a shower, even though I showed him that the tub was
completely dry. He was caught in lies like that all the time.
As he grew into a young man, we talked about it, and he said he
realized how silly it was. I was convinced he had outgrown it.
In December 2003 I discovered that he had not. At the time,
Jason was halfway through his second year at college as a pre-
pharmacy major. Since his dorm was only 45 minutes away, he
came home frequently on weekends often, to work at the pharmacy
where he had a job since high school. On one Sunday night I
remember saying goodbye to him at our front door. As I often
did, I put my hand on his cheek. I loved the scruffy feel of
his stubble, it reminded me that my little boy was growing up.
I caressed Jason's cheek that night and told him I love him.
Three days later, on the morning of December 17, 2003, my
husband called me at work to tell me that the hospital had
called to say Jason was brought to the emergency room and we
should come as soon as we can. We met nearby and drove to the
hospital together, in silence. We couldn't imagine what had
happened. My husband had spoken to Jason the day before and he
said he sounded fine.
When we arrived at the hospital, the first thing I remember
was being referred to as ``the parents'' and being ushered into
a private office. I used to work in hospital administration,
and I knew what that usually meant, but this had to mean
something different. We asked to see Jason and were told we had
to wait to speak to the doctor; again, a sign I knew but I
could not accept.
I have relived that day in my mind so many times, but I
really can't tell you exactly what the doctor said. The message
was clear: My beautiful son was gone. Apparently Jason had been
abusing prescription drugs and had overdosed. He was 19 years
old.
This couldn't be possible. I work in prevention. He knew
the dangers, we talked about it often. I was so convinced that
he was not using drugs, it became a sort of joke between us. As
he would leave home at the end of a weekend I would say, Jason,
don't do drugs. And he would say, I know, Mom; I won't. But he
did.
While speaking with dozens of Jason's friends after his
death, we learned that his abuse of prescription drugs may have
started after he began college, and apparently started to
escalate the summer before he died.
I know he believed he was being safe. He used the Internet
to research the safety of certain drugs and how they react to
others. As a pre-pharmacy major, he probably thought he knew
more about the drugs than he actually did. We also learned that
he had visited several on-line pharmacies to order drugs from a
Mexican pharmacy on the Internet that automatically renewed his
order each month.
I think back to the last several months of my son's life,
trying to identify any signs I might have missed. During his
first year of college I discovered an unlabeled bottle of pills
in Jason's room. After some research, I identified them as a
generic form of Ritalin. When I confronted Jason, he told me he
had gotten them from a friend who had been prescribed the
medication; he wanted to see if they would help him with his
problem focusing in school. I took that opportunity to talk to
him about the dangers of abusing prescription drugs. I told him
that if he really thought he had ADD, we should pursue it with
a clinician. He promised he would stop using the drug, and even
called the counseling office at school to make an appointment
for evaluation.
The only other sign I can remember was that 1 weekend when
Jason was home, I passed him in the kitchen and noticed that
his eyes looked strange. I confronted him right then and there
and asked him if he was on something. He said, No, what's
wrong? And he went over to a mirror to look and see what I was
talking about. He said he didn't know what was wrong, maybe it
was because he was tired. I was suspicious but his behavior was
perfectly normal, so I let it go. There were no other signs
until we got that horrible call on December 17, 2003 that
changed our lives forever.
There are things being done to address this new drug
epidemic, but we need to keep moving forward. With the support
of my office, we have developed a number of initiatives in our
community to raise awareness about the dangers of prescription
drug abuse. Something as simple as a mouse pad in a high school
has already made a difference in someone's life. Something as
profound as supporting the Ryan Haight Internet Pharmacy
Consumer Protection Act can save so many lives.
Jason touched so many lives in such a short time. He had
many friends who cared deeply for him but just didn't know how
to help. I believe education is key to preventing this tragedy
from repeating. By sharing Jason's story, I hope we can help
other families avoid the kind of heartache that my family his
suffered.
Thank you for listening. I'm happy to answer any questions
you might have.
Mr. Souder. Thank you.
[The prepared statement of Ms. Surks follows:]
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Mr. Souder. Next is Barbara van Rooyan.
STATEMENT OF BARBARA VAN ROOYAN
Ms. Van Rooyan. Chairman Souder and other members of the
subcommittee, my name is Barbara van Rooyan. I'm a California
college faculty member and a mother of two sons.
My son, Patrick Stuart, died in 2004 after ingesting just
one OxyContin. He had no other drugs in his system, and only a
small amount of alcohol.
He was a college graduate, a graphic designer, and a
certified personal trainer. He made the tragic mistake of
believing someone at a Fourth of July celebration when he was
told that OxyContin was prescription and FDA approved, and
therefore safe. As happens with someone who is intolerant to
opioids, he stopped breathing in his sleep. After 5 days in a
coma, Patrick was reported to have no brain activity. We
arranged for organ donation as we said our last goodbyes. Only
his lungs could not be shared; the OxyContin had destroyed
them.
In my grief, I learned very quickly about OxyContin and
prescription drug abuse. And what I learned I felt compelled to
share with others. So during a partial sabbatical leave from
the college, focusing on prescription drug education, I told
Patrick's story to hundreds of college and high school
students, faculty, staff, and administration. I learned from
them as they learned from me. I learned that young people
believe prescription FDA-approved drugs are safe, and that
taking them is not doing drugs.
Contrary to the testimony of the first panel at this
subcommittee hearing this morning, young people are getting
prescriptions from their doctors and they are getting them from
the medicine cabinets of other family members who are getting
prescriptions from their doctors. Overprescribing is a huge
problem with OxyContin.
I also found that most teachers, counselors,
administrators, and parents are in the dark about prescription
drug abuse.
Soon after Patrick's death, I requested that the Anesthetic
and Life Support Drugs Advisory Committee of the FDA meet to
discuss OxyContin, as they had new membership. Repeated
contacts with FDA officials, including a letter from Senator
Feinstein, yielded no results. So in February 2005, my husband
and I submitted a Citizen Petition to the FDA requesting that
OxyContin and Palladone be reformulated as ``abuse resistant''
and be relabeled ``for use with severe pain only.'' The
relabeling alone would powerfully reduce the number of deaths
and addictions to OxyContin without compromise to terminally
ill or dying patients' access to the drug. I received only one
communication from the FDA regarding the Citizen Petition. That
was a letter stating that they needed more time for review.
Subsequently, Palladone has been targeted for
reformulation. However, last month the FDA approved Opana, a
sustained-release opioid, without first resolving OxyContin
problems.
It has now been over 10 years since OxyContin first came on
the market. The deaths and addiction continue, unabated.
The 2005 Castle Report states about half of all doctors do
not receive medical school training in prescribing controlled
substances, addiction or diversion of drugs. Yet in 2002,
OxyContin was one of the most widely prescribed opioid
medications, with an increase of 380 percent in a 10-year
period. Purdue Pharma's greed and FDA approval of OxyContin for
moderate pain are primarily responsible for this increase.
I'd also like to mention that, again, contrary to the
testimony of the first panel this morning, the 2005 Waismann
Opiate Dependency Survey indicates that 71 percent of their
patients who are addicted to opioids were originally prescribed
an opioid by their doctor.
In 2001, the Attorney General of Connecticut pleaded with
Purdue Pharma and the FDA to take steps to stem the tide of
death and addiction to OxyContin. In 2004, Fred Pauzar, another
parent who lost a son to OxyContin, came before this very
subcommittee and asked the same.
Today, more than a decade after OxyContin was first
unleashed, I am asking the same once again. There must be, at
the very least, more assertive and comprehensive actions by the
FDA to protect citizens, increase mandatory physician education
regarding selective opioid prescribing and a balanced approach
to pain management, youth and family prescription drug
education.
I come before this committee today because my son is dead.
I will forever mourn. I also come before this committee today
because my son stands at my right shoulder and each day he
tells me, ``Mother, it is better to light one candle than to
curse the darkness.'' I will light as many candles as
necessary, and I hope that you will too.
Mr. Souder. Thank you for the testimony. And if you could
get us some more information on the survey, we'll make sure we
get that in the record.
[The prepared statement of Ms. Rooyan follows:]
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Mr Souder. Next is Ms. Falco.
STATEMENT OF MATHEA FALCO
Ms. Falco. Thank you, Mr. Chairman, and thank you all for
your leadership on this very, very important issue. The
testimony that we just heard I think overwhelmingly makes the
case that action is needed.
I am the president of Drug Strategies, a nonprofit research
institute, and we have put together in the last year and a half
a collaboration, including the Weill Medical Center in New York
City, the Treatment Research Institute at the University of
Pennsylvania, and Harvard Law School to develop a private/
public partnership to try to look at ways in which we can
curtail the sale over the Internet of these highly addictive,
lethal narcotic drugs, without prescription. If you type in the
term ``OxyContin without prescription'' in any search engine,
you will immediately get hundred of ads willing to sell you--
without even pretending to go through a prescription process--
these drugs. So we are very concerned about this. We believe in
our collaboration that the government has a vital role to play,
the Federal agencies do. But we thought perhaps progress could
be made immediately, even in small ways, by engaging the key
points along the chain of Internet commerce that basically got
the drugs off the Internet, through the Internet into the homes
of what are essentially adolescents. Nora Volkow testified this
morning that this is an epidemic among teens; that, I think,
has been proved beyond question.
Our partnership looked at the key targets, really. How are
these drugs purchased over the Internet? Well, with credit
cards for the most part. So we've been working with MasterCard,
Visa, American Express to look at steps they can take, without
any formal governmental action, to try to track down who these
illicit sellers really are. The Internet service providers are
also very concerned that, in effect, they have become a river
which connects this illicit traffic which increasingly, I must
point out, comes from Web sites hosted overseas. So this is
rapidly becoming an international, not just a domestic problem.
The ISPs have been extremely responsive in trying to think
of technological ways in which they can help filter out some of
this solicitation. We are also working with, as I said,
government agencies; with the State Department. I talked to the
Department of Justice about things that might be done, but I
think that the profound point here is that this is such a huge
problem, we're at the beginning of what everyone agrees is an
epidemic, we need to look for as many targets as we can. And I
think everyone today has very specific suggestions about what
might be done. Clearly education and prevention, the
Partnership For a Drug-Free America, all of these things are
very important.
We convened a conference 2 weeks ago at Harvard Law School
of this collaboration, and very high-level representatives of
many of these companies were in the process of refining
recommendations. We hope very much at the end of the year to
come up with some very specific recommendations which the
private companies have already bought into, so to speak, so
that we can come forward with a combined voice, because we do
believe very much in the business response to these things.
And we would like very much to continue to work closely
with your staff. The staff has been extremely helpful along the
way. And we think that even down the road we might need to come
back and ask for specific legislation; we aren't quite there
yet. And we've called our initiative, Keep Internet
Neighborhoods Safe. And with the same notion that we try to
protect our children from the terrible dangers of society
today, even getting run over by cars when they're little
children, we need to try to make the Internet safe for our
children. And that's essentially what this private/public
collaboration is doing.
I thank you very much, and I hope we'll come back to you
very soon.
Mr. Souder. Thank you very much for your actions and your
testimony.
[The prepared statement of Ms. Falco follows:]
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Mr. Souder. Next, Mr. Stephen Johnson.
STATEMENT OF STEPHEN E. JOHNSON
Mr. Johnson. Chairman Souder, Ranking Member Cummings, and
members of the committee, I'm Steve Johnson, executive director
of commercial planning at Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company
specializing in the research and development of safer drugs for
use in pain management. We commend the subcommittee for holding
this hearing, and I'm grateful for this opportunity to discuss
what is becoming an enormous health problem.
As the subcommittee knows all too well, prescription drug
abuse continues to have a widespread and devastating effect on
American families, businesses, and our society as a whole. For
abusers, the appeal of a prescription drug typically depends on
its dose strength and the ease with which it can be abused.
Illustrative is OxyContin, a strong oral opioid drug, typically
prescribed to treat moderate to severe pain. That is also
reported to be one of the most commonly abused prescription
products.
Drug abusers, however, can quickly and simply disable
OxyContin's controlled release mechanism, usually by crushing,
breaking or chewing a tablet. The extracted active ingredient,
oxycodone, is then ingested, snorted or injected, immediately
releasing into the body a dose that was intended to be
delivered over a 12-hour period.
Despite the tireless efforts of thousands of Federal, State
and local officials, the incidents of prescription drug abuse
has continued to rise even as the rate at which other
categories of illicit drug use have decreased or remained
stable.
The criminal and civil liability and theft associated with
products such as OxyContin are discouraging some doctors from
prescribing the pain treatments their patients need and
dissuading some pharmacists from stopping them. This is a
tragedy, for pain is already too often undertreated. Clearly,
additional methods of combating prescription drug abuse are
necessary.
At Pain Therapeutics, we believe pharmaceutical technology
is a potential critical tool in the battle against prescription
drug abuse. For example, our investigational drug product,
Remoxy, is a novel form of oxydodone contained in a highly
viscous fluid formulated to resist tampering or accidental
misuse. While Remoxy is not intended to be abuse-proof, it is
formulated to resist breaking, chewing or crushing. We believe
this investigational drug will also reduce the potential for
accidental overdose among patients who may innocently crush or
chew a tablet.
Moreover, we expect Remoxy's advanced technology to be
useful in reformulating other commonly abused opioid drugs, as
well as other drugs, rendering them similarly abuse-resistant.
We are taking a very different approach to reducing
prescription drug abuse in developing Oxytrex, an
investigational drug product that combines oxycodone, an opioid
agonist, with an ultra-low dose of opioid antagonist. Research
has shown that the addition of an ultra-low dose opioid
antagonist blocks activation of the body's excited opioid
receptors, while allowing the agonist to block the transmission
of pain signals. We are working to demonstrate that Oxytrex can
significantly inhibit pain while simultaneously reducing the
risk of physical dependence.
In addition to potential law enforcement benefits, the
development of such products represents a new and efficient
means of addressing current concerns regarding prescription
drug safety without further restricting or discouraging access
for patients who need such care.
Pain Therapeutics is not alone in recognizing the potential
benefits of formulating prescription drugs to reduce abuse. In
recent years, Congress and various governmental entities and
private organizations have recognized the need to develop
abuse-resistant prescription drugs. Most recently, the Office
of National Drug Control Policy recommended continuing to
support the efforts of firms that manufacture frequently
diverted prescription drugs to reformulate their products so as
to reduce diversion and abuse.
Additionally, NIDA Director Dr. Nora Volkow recently co-
authored a paper on opioid analgesic abuse, calling for
development of less abusable but still potent forms of opioid
agents, as well as combinations of medications that can be
given to treat pain, but to minimize the chances of addiction.
In 2005, the comprehensive report by the National Center on
Addiction and Substance Abuse at Columbia University went even
further, asserting the FDA should require pharmaceutical
companies manufacturing controlled drugs to formulate or
reformulate the drugs where possible to minimize the risk of
abuse. ``pharmaceutical companies should be required to
demonstrate in their application materials for FDA approval of
new drugs that they have made every effort to formulate the
drug in such a way that avoids or least minimizes the drug's
potential for abuse.''
Now we must turn these statements into real public health
and law enforcement achievements. Currently, there are no
Schedule II prescription drugs on the market specifically
formulated to resist or reduce abuse. Moreover, no statute,
regulation or guidance specifically addresses issues that are
critical to determining whether it will continue to be
worthwhile to invest in the research and development to bring
such products to market.
This subcommittee can play a unique role in ensuring that
agencies across the government coordinate their efforts to
maximize the benefits of pharmaceutical technology and
addressing drug abuse and misuse.
To conclude, we have four recommendations:
No. 1, applications to market prescription drugs that are
especially formulated to deter abuse or misuse should be
eligible for priority review.
No. 2, FDA should permit labeling that accurately conveys
the specific means of abuse or misuse to which a product has
been shown to be resistant; and the agency should not require
companies to demonstrate resistance to all potential methods of
abuse and misuse such as those that are relatively uncommon.
We welcome FDA's recent announcement that it intends to
develop this year guidance for industry in this area. We are
hopeful that prompt issuance of these documents will eliminate
some of the current ambiguity by framing reasonable standards
for approval and accurate labeling that clearly differentiates
products incorporating such technologies for products providing
no abuse.
No. 3, risk management plans for potentially abusable drug
products should take into account these innovative safeguards
and encourage physicians to prescribe those products that deter
abuse and misuse, while also discouraging use of prescription
drugs known to be readily abusable.
And No. 4, given the cost to our health care system, we
must ensure that both private and governmental payers and
Medicare and Medicaid recognize the benefits of these products
and favor their use and formularies.
Mr. Chairman, we are especially grateful to you and the
other members of the subcommittee for calling attention to this
issue today. We look forward to working with Congress and other
governmental agencies to continue to develop the innovative
approaches to more effectively approach the epidemic of
prescription drug abuse. Thank you.
Mr. Souder. It would be nice if they took a normal
definition of prompt.
[The prepared statement of Mr. Johnson follows:]
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Mr. Souder. Dr. Manchikanti.
STATEMENT OF LAXMAIAH MANCHIKANTI, M.D.
Dr. Manchikanti. Mr. Chairman, I would like to thank you,
the committee members, and staff for giving us this opportunity
to speak.
My name is Laxmaiah Manchikanti. I am a practicing
physician from Paducah, KY. I am also the president and CEO of
the American Society of Interventional Pain Physicians. The
issues are very close to me as a physician and as the CEO of a
group representing approximately 3,700 members. I have
published multiple articles on this subject as part of the
education and certification programs and controlled substance
management published guidelines that were instrumental in the
design and passage of the National All Schedules Prescription
and Electronic Reporting Act [NASPER].
Our members are involved in prescribing controlled
substances. However, our primary modality of treatment is
intervention techniques. I have provided the committee with
information. During the next few minutes I would like to
discuss specific issues related to chronic pain and
prescription drugs.
Today, chronic pain is estimated in approximately 10 to 30
percent of the population in the United States. As we heard
from the earlier witnesses, psychotherapeutic drugs, which
include pain deliveries, tranquilizers, stimulants, and
sedatives are the second leading category of illicit drug use.
Between 1992 to--sorry--2003 the U.S. population increased 14
percent, but the number of people abusing prescription
controlled substances increased 94 percent. Mr. Chairman, as
you have stated in your opening statement, the increase of
prescription controlled substances was double the increase of
marijuana, five times that of cocaine and 60 times the increase
of heroin.
In recent years there have been sharp increases in the
therapeutic use of controlled substances coupled with misuse
and abuse. Today, 90 percent of the patients presenting in pain
management centers are on opioids; opioid prescriptions sales
are increasing rapidly.
Drug abuse in chronic pain management is common. Today,
with all the available tools, with prescription monitoring
programs, random drug testing and vehicle license, it has been
reported that 9 to 20 percent of the patients still abuse their
drugs. In addition, illicit drug use is common in as many as 32
percent of the patients.
Drug diversion is an epidemic in the United States. The
majority of physicians perceive doctor shopping as the major
mechanism of diversion. Patients and physicians alike are
facing a multitude of problems. Physicians feel that patients
deceive and manipulate the doctors and authorities around their
tale. We have patients that feel undertreated for their pain
and it is their fundamental right to be pain free by whatever
means.
Many programs are in place to deal with this. The Drug
Enforcement Agency is in the forefront of it. NASPER was signed
in to law on August 11, 2005, but it is moving extremely slow
with no funding coming yet.
At the present time, there are approximately 32 or 33 State
programs under DEA that had programs. Many of these programs
are reactive rather than proactive, and they are limited to a
single State. With this--to combat this epidemic and improve
patient care, we must include mandated care and continuing
education care for physicians, pharmacists and the public.
The public must be educated on non-opioid techniques of
pain management and the effects of opioid treatments. In
addition, the program is ideal and necessary. Enactment of
NASPER in all States is the major solution for the existing
problems. This will benefit physicians, patients and the DEA
with honest patients receiving a proper treatment and
physicians providing proper treatment without hassles.
Other strategies may include increased strategy of
methadone treatment, increased eligibility of outpatient
detoxification and rehabilitation--improvement of
rehabilitation, and finally, elimination of Internet
pharmacies.
Thank you.
Mr. Souder. Thank you.
[The prepared statement of Dr. Manchikanti follows:]
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Mr. Souder. Mr. Pasierb.
STATEMENT OF STEPHEN J. PASIERB
Mr. Pansierb. Thank you. Thanks to Ranking Member Cummings
for inviting the Partnership here to testify today. I have also
got to take the opportunity to thank the subcommittee for using
its leadership in your steadfast dedication over the last 2
years in the drug issue, helping the American family navigate
through the issues that we have been faced with. So, on behalf
of all of us, I did want to get that one bit of thanks out
before I got into my testimony.
We are encouraged, as you have heard in the testimony
today, that drug use among teens has decreased 19 percent since
2001. However, when you examine individual drugs of abuse,
there are very troubling trends, including the abuse of
methamphetamine regionally, resurgence in inhalants and in
prescription and over-the-counter medications.
The Partnership is particularly concerned about this new
tier of teen abuse, that we have dubbed Generation Rx, which is
really a cohort of young people for whom ``pharming'' with a
``ph'' or the behavior of partying or abusing a host of
medicines to get high has become normative. This is not an
issue of individual products, as we have heard, but rather it
is a broad and negative behavior that has become far too common
and acceptable in today's teen culture. These are medications
that when used as directed improve health and even save lives.
But there is a world of difference between good medicine and
bad behavior.
The Partnership and our partners have been focused on this,
doing research over the last year and a half. We're targeting
this behavior now, and our dedication is to change this
dangerous conduct.
Our 18th annual Partnership Attitude Tracking Study
examines both teen drug use and attitudes, and that study
confirmed alarming number of today's teenagers more likely to
have abused medicines than a variety of illegal drugs like
Ecstasy, cocaine, crack and methamphetamine. Nearly 1 in 5, or
4.5 million, teens has tried a prescription medication to get
high, and 1 in 10, or 2.4 million, teens report abusing cough
medicine to get high.
There is also a false sense of security about abusing
medications because they are FDA-approved, legitimate and
otherwise beneficial products in the medicine cabinet. The
study shows that there is much work to be done to educate teens
about the dangers of intentional abuse.
Two of five teens, or 9.4 million, mistakenly agree that
prescription medicines even when not prescribed by a doctor are
much safer to use than illicit drugs. Nearly one-third of
teens, or 7.3 million, believe that there is nothing wrong with
using prescription drugs once in a while without a
prescription. More than half of teens, 13 million, don't
strongly agree that using cough medicines to get high is risky.
Teens are also telling us in our studies that it's very
easy for them to gain access to these medicines. Many teens say
that they are easily available in the medicine cabinet at home
or at a friend's house. They are easy to get through other
people's prescriptions; and teens say these medications are
available everywhere, including the Internet.
Easy access combined with very little understanding of the
consequences can be a lethal combination and has all of us
quite concerned. What is more, today's parents are the most
drug experienced in history, but they do not understand this
new form of abuse among teenagers. As a result, they think that
if they have talked about street drugs, they have done their
job.
Parents need to be aware of the drugs teens abuse today,
including medicines, are not the same drugs as in decades past.
Only through education and parental involvement can we be
successful. Once parents are educated about the intentional
abuse of these products, then they can get through to kids
about the dangers. We know kids who learn a lot about drug use
at home are up to half as likely to use. But while 9 out of 10
parents say they've talked about the dangers, fewer than one-
third of teens say they learn a lot at home about the risks of
drugs.
And we know from the additional studies, only one-third of
parents say they've talked to their kids specifically about the
risks of abusing medicines to get high.
Focus groups show parents generally don't think their teens
could be vulnerable to over-the-counter drug abuse. They don't
understand the idea of this behavior. And like too many teens,
they somehow think that abusing medicines is somehow safer than
illicit street drugs and that has to change. That is why The
Partnership and our partners, including the Consumer Health
Care Product Association and its members, launched a new
education campaign on May 1st that I can sum up in 3 words:
educate, communicate and safeguard.
As a parent, educate yourself about the medicines kids are
abusing; second, communicate with your kids on this subject and
dispel the notion for yourself and your kids that these
medicines can be safely abused; and finally, safeguard your
medications, limiting access to them and keeping track of the
quantities you have in your home and making sure your family
and friends do the same. Parents are going to see that message
on television, in newspapers, in magazine ads and on the radio.
The Internet also plays a role with resources for parents
at Drugfree.org and specifically for teenagers who visit
dxmstories.com. We would like to show examples of the campaign.
[Video presentation.]
[Note.--The DVD is on file with the subcommittee.]
Mr. Pasierb. So our bottom line is, we are going to be
evaluating this effort over the next 3 to 5 years, and we know,
through the research that has already been done, that received
communications can change behaviors. This is a public health
problem and we, The Partnership, are convinced that if this
issue gets the attention it needs and industry is motivated in
joining us to find solutions, and when this campaign gets the
visibility it needs, we are going to be successful in rooting
out this behavior and changing attitudes, changing behaviors.
I want to thank the committee. And please know that our
dedication is to working with you to find solutions on this
problem. Thanks.
[The prepared statement of Mr. Pasierb follows:]
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Mr. McHenry [presiding]. Thank you so much for your
testimony and for showing the ads as well.
I have a few questions. Mr. Cummings, of course, will have,
as I understand, a few questions as well.
But if we could start with Mr. Johnson. My understanding
is, the makers of OxyContin said it would be more than a
decade--it would take more than a decade to reformulate
OxyContin to be abuse-resistant in that form. I am not asking
you to divulge industry secrets or anything of that nature,
but--you know, describing the specifics on how the product
works, but there are some--what is the difference here?
It is a large company that produces OxyContin. What is the
problem? Why--you know, why are they claiming this can't be
done any time soon?
Mr. Johnson. I can't comment on or guess as to reasons why
another company can't move forward in this area, but it's--our
efforts are all about reformulating the drug to protect against
the common methods of abuse which have been deliberated on the
panel and by the DEA.
If you reformulate, using materials that are resistant or
deterrent to abuse, then you essentially lock in drugs for
patients who are trying to abuse or mechanically get drugs out
of the system. If you take the drug as directed, then it
delivers the dose to the patient over time.
Mr. McHenry. Can you describe how your product works
differently?
Mr. Johnson. It is a gel-based delivery system. This is an
example of the main ingredient. It's called sucrose acetate
isobutyrate. I am not a scientist, but it is called SAIB. At
any rate, it is a very viscous--it is called a creeping fluid.
I turned it on its side about 15 minutes ago and it hasn't
completely gone that way. That is the main ingredient.
Then we add another additional ingredient, I should say, to
combat specific types of abuse.
So, again, if you take the drug as prescribed, it delivers
the dose nicely over a 12-hour period and the patient gets pain
relief. If, on the other hand, someone tries to abuse it,
someone tries to crush it and snort it, you can't freeze it to
a temperature that makes it brittle enough to actually defrag
the delivery system and turn it into just a drug, as you can
with some of the commonly available drugs. You can't.
We are doing studies to look at injecting the drug, and we
have gotten down as far as an 18-gauge needle, which is very
large, and even if you get the drug into a syringe, it still
pops the needle off the end of the syringe.
When you challenge the drug with alcohol, which is a common
method of abuse of some of the others, we have an excipient
that locks in the drug. So some gets out, but a very small
percentage; somewhere around 20 percent of the drug gets out.
So if someone is playing with it, you know, hopefully they'll
learn from a mistake and wake up the next morning.
Those are some of the differences.
Mr. McHenry. Do you think it is the absence of laws that
are on the books about abuse-resistant prescription drugs that
is contributing to very few of them being on the market?
Mr. Johnson. I think it creates a situation of ambivalence,
or ambiguity rather; and this is where there is ambiguity,
there is uncertainty.
From a business perspective, you don't want to invest your
money in something that is highly risky unless you have money
to throw away, which most companies don't, I think. You want to
derisk it as much as possible.
There is no clinical path for approval of these drugs.
There is no guide to tell industry what you need to do and what
hurdles you need to cross to get these drugs approved, so I
think the lack of guidance is a significant issue.
Mr. McHenry. Since this is sort of the general perception
and understanding from industry, there is this perception that
prescription drugs--as the ads outline, that they are somehow
safe to abuse--as astronomically idiotic as that seems in this
committee room, it is a reality outside, in America.
Do you think it is the idea that FDA approves drugs or that
somehow they are safe, that they're approved, and this creates
the perception among youth that it is OK?
I mean, if we could just have the whole panel to touch on
that, give your comments on that.
Ms. Van Rooyan. In the hundreds and hundreds of college and
high school students that I have spoken with over the past
year, I would say unequivocally that is an issue. In addition
to what I hear from young people is that they have grown up in
a culture of taking some kind of medication for almost every
ache and pain that comes along. And so, to them, you know,
taking a prescription pill is almost in some instances like
taking a vitamin or taking an aspirin if you have a headache;
or gosh, if you have a stomachache, you know, take a little of
this or take a little of that.
So many of the young people I speak to, taking a medication
is nothing to them; they've grown up in that culture.
Mr. Pasierb. I think one of the things we saw was teens and
parents shared the same view. I think parents were a little
further beyond teens, thinking this was safer and there was
less stigma attached to this. Many parents got that their own
homes were a source of it, but they weren't doing anything to
safeguard it, and I think it is the ubiquity of medicines in
our lives. These are things that we all use to feel better and
improve our lives, that safety veil which is so important, that
is something in the American society that is now working
against us in this case; and our kids are thinking this is a
safer alternative.
And it is a tragically wrong conclusion, as you have heard
this morning, from folks here.
Ms. Fetko. I just want to add, speaking with Carl's friends
after he passed away, they just could not believe that
something like this could have resulted from abusing these
drugs. They were absolutely incredulous. They had no idea. And
these were intelligent young men.
Ms. Surks. I had the same experience. I spoke with a number
of Jason's friends, and they just--they were amazed and shocked
that this could have happened to him.
Ms. Falco. I just wanted to add, the ready availability of
these drugs beyond the family medicine cabinet. The Internet is
going to emerge increasingly as the route for obtaining these
drugs. Every kid in America is on line at least 3 or 4 hours a
day. It is very easy to get these drugs without prescription,
without the pretense of a prescription.
And as, in fact, we increase our ability to control the
U.S. supplies and the U.S. requirements for prescriptions, this
business will move offshore. It already has started to do so.
And that will make control, at least from the supply end, even
more difficult. That is why it is so important to engage the
private sector players in this--the carriers who deliver the
drugs, the credit card companies through which these drugs are
purchased, the banks which approve the credit cards.
And, of course, there is this very important part of
education, which by the way the search engines and the Internet
service providers can also do through their huge networks and
huge customer bases. That is what we are talking about right
now coming back to you with recommendations along those lines.
Mr. McHenry. It is interesting you mention selling
prescription drugs over the Internet. I had a pharmacy that was
relieved of its license to issue drugs in the State of North
Carolina because they were sending drugs across the country,
which was strictly prohibited under North Carolina law. So it
was interesting to see the pharmacy board in North Carolina
really take on a challenge that may be largely, you know, a
Midwest, a West Coast issue because this pharmacy was accepting
orders for drugs across the country and how they were actually
protecting people. So that is very helpful.
My time has expired, and we'll go to the ranking member,
Mr. Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman. Let me
just ask a few questions here.
Ms. Falco.
Ms. Falco. Yes, sir.
Mr. Cummings. How soon do you plan to come with those
recommendations? And as I said a little bit earlier, this has
been going on for a long time, and I am trying to figure out--I
guess the older I get, the more I get frustrated. We study
stuff and then we put it on a shelf, then we dust it off, warm
it up, bring it back out; and a lot of times nothing happens.
And so and I am not--believe me, I am glad you are trying
to do something. We are up here and we have just as much
responsibility. But one of the things that I have concluded is
that whenever something is driven by money and profit, it is
hard. It is hard to stop it because basically it takes on a
culture and a life of its own.
And so how soon do you think you'll see these
recommendations, and what is the process of getting them to us?
Ms. Falco. Fortunately, we have had the benefit of being
able to work with committee staff. We are on a very fast track
because we share your frustration. We hope that before the end
of the year we will have developed very clear, specific
recommendations that touch a wide range of private sector
players in the Internet drug commerce, e-commerce. And I think
that there will be some very--hopefully, some very specific
recommendations that Congress might undertake.
I think the interest of this committee and your persistence
in staying with this issue, in spite of the terrible
frustration of studies that don't result in anything, have
already begun to have an impact on the willingness of private
companies to step up to the plate. They are not going to make--
I am not speaking on behalf of any specific company, but let me
just say that the credit card companies are not making most of
their money off of this kind of commerce. They don't want to be
associated with bringing these terrible drugs into the homes of
our children.
I think there is a lot of common ground out there in the
public sector and the private sector that we can really work
on; and if we can continue to work with your staff, we will be
back to you very soon.
Mr. Cummings. Well, to Ms. Fetko, Ms. Surks and Ms. van
Rooyan, I want to, first of all, express my sympathy to all of
you. And I want to thank you for being a part of this and what
you are doing.
I have often said that out of some of the most tragic
things that happen can come some good things. Sadly, so often
we have to suffer so that others might live and so that others
might have a better life, and I thank you all for not taking
your grief and going off into a corner, but coming out and
saying, look, you know, I want to make sure that this doesn't
happen to anyone else.
So I thank you not only on behalf of our committee, but on
behalf of so many people that will be affected by what you do,
that you will never meet and you will never know because they
won't--and they may not know you. But because of what you do
today, you may very well--I am sure you will save many, many
people and save a lot of mothers from going through the pain
that you have gone through.
Is there something that when you go back and you reflect on
what you've seen and what you have experienced, is there
anything, other than in the gist, that you would have loved to
have seen government do?
Here we are in the business of trying to create laws, and
one of the things that we did see is that when we took on the
steroid issue, it was largely because of children. We were
tired of seeing children emulating the great baseball,
basketball, football players. And a lot of children did not
understand that when they tried to emulate these big-time
players, they could literally destroy their bodies.
And so we heard testimony from parents who came in here and
said, We lost our son because he was trying to be like somebody
he had seen on television. I'll never forget when we did that,
when we held those hearings, a lot of people said, Oh, you are
just grand-standing. You shouldn't be involved in this process;
it is none of your business.
But I do believe that it has had a tremendous impact. And
so what we are trying to figure out constantly is, what is it
that we can do to try to--as legislators, try to help with the
problem and understand with the steroid issue it wasn't just
what we would do legislatively, but it would go back to what
Ms. Falco is saying.
A lot of times when the voices come from the
representatives of the people, industry and a whole lot of
other folks begin to do things a little different than they
would normally do them because they don't want laws to come
down--you know, for us to create laws that affect them in a way
that, you know, they may very well not feel comfortable with.
So are there any things that you can think of that you
haven't already touched on that you would have loved to see the
government do?
Ms. Van Rooyan. Yes. This is in my written testimony but
not in my summation.
National prescription monitoring systems have to be in
place, and there needs to be Federal appropriation of funds for
that. Right now, in California, we most recently, as of January
2006, implemented and expanded a prescription drug monitoring
program known as CURES. This is just the first leg of a
monitoring system that, with the second leg, would involve
having online access for all physicians and pharmacists to
information on any patient's controlled substances.
The really unfortunate piece of this is that this expansion
of the program in California only came about because Bob and
Carmen Pack of Danville, California, lost their 7-year-old and
10-year-old children when a woman who was addicted to Vicodin
and was under the influence of Vicodin ran into them with her
car. And they found out during the trial that she had had six
prior--prior to the crash, she had had six prior prescriptions
filled from six different physicians all within the same HMO,
none of whom corroborated any of the claims of injuries that
she had.
So, obviously, our prescription monitoring system in our
States are failing. And the Packs are at a point right now
where this--there is only enough State funding for the first
leg of it. They are looking to the pharmaceutical companies and
the Federal Government for the funding in this prescription
monitoring, CURES, in California.
So that is one way I see that the government can help.
Mr. Cummings. Thank you.
Ms. Surks.
Ms. Fetko.
Ms. Fetko. A couple of things that, as I evaluated my
experience: I wish that Carl was not able to walk into a
pharmacy and purchase the cough syrups. Also, in regards to the
Fentanyl, my suspicion is that it came from a home where a
patient was being cared for at home. And finding ways to
increase the accountability for the prescription drugs that are
available to those patients in the home, as far as dispensing
accountability for how many--how much drug is there and
disposing of it after its use.
Mr. Cummings. OK.
Ms. Surks. It has already been mentioned. I think it is
critical that we find a way to control the easy accessibility
of these drugs over the Internet. The recommendations that the
drug strategy is working sounds like it will approach that
protection of our children.
I also think that education and prevention need to be
supported. I know I work in prevention, and we do a lot to
educate young people, parents; and that needs to be across the
board, across the country. Everyone needs to have access to all
of the information.
And so I think there needs to be support of the prevention
efforts.
Mr. Cummings. Are you--have you worked with these ladies,
Ms. Falco?
Ms. Falco. We are going to.
Mr. Cummings. I was going to suggest that you do that.
Again, I want to thank all of you for your testimony. I
don't know what is going to happen, but I can tell you that we
are going to stick with the issue because it is so important.
And thank all of you very much.
Mr. McHenry. We certainly appreciate your taking your time
to come to Capitol Hill and tell your stories, and we certainly
appreciate your input and guidance. For those that were not
able to attend the committee hearing, they will read the
testimony, as I did because of a prior engagement.
So thank you for your written testimony. Thank you for
answering questions and thank you for your time. Thank you and
have a wonderful afternoon.
This committee meeting is adjourned.
[Whereupon, at 1:10 p.m., the subcommittee was adjourned.]
[Additional information submitted for the hearing record
follows:]
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