[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]




 
 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
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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:]

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    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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