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35–338 PDF 2007

PRESCRIPTION DRUG ABUSE: WHAT IS BEING

DONE TO ADDRESS THIS NEW DRUG EPIDEMIC?

HEARING

BEFORE THE

SUBCOMMITTEE ON CRIMINAL JUSTICE,

DRUG POLICY, AND HUMAN RESOURCES

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

SECOND SESSION

JULY 26, 2006

Serial No. 109–237

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

CHRISTOPHER SHAYS, Connecticut

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

CANDICE S. MILLER, Michigan

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

JEAN SCHMIDT, Ohio

BRAIN P. BILBRAY, California

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

BRIAN HIGGINS, New York

ELEANOR HOLMES NORTON, District of

Columbia

———

BERNARD SANDERS, Vermont

(Independent)

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

DAN BURTON, Indiana

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

STEVEN C. LATOURETTE, Ohio

CHRIS CANNON, Utah

CANDICE S. MILLER, Michigan

VIRGINIA FOXX, North Carolina

JEAN SCHMIDT, Ohio

ELIJAH E. CUMMINGS, Maryland

BERNARD SANDERS, Vermont

DANNY K. DAVIS, Illinois

DIANE E. WATSON, California

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

MAJOR R. OWENS, New York

ELEANOR HOLMES NORTON, District of

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

(III)

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

Page

IV

Letters, statements, etc., submitted for the record by—Continued

Volkow, Dr. Nora D., Director of the National Institute on Drug Abuse,

prepared statement of ................................................................................... 29

(1)

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

2

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.

3

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

4

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 multifaceted response, and I would like to see Congress and the adminisVerDate 11-MAY-2000 09:03 Jul 16, 2007 Jkt 000000 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 C:\DOCS\35338.TXT HGOVREF1 PsN: HGOVREF1
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tration 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.

11

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

12

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

28

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 asVerDate 11-MAY-2000 09:03 Jul 16, 2007 Jkt 000000 PO 00000 Frm 00048 Fmt 6633 Sfmt 6633 C:\DOCS\35338.TXT HGOVREF1 PsN: HGOVREF1
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sumed 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 inacVerDate 11-MAY-2000 09:03 Jul 16, 2007 Jkt 000000 PO 00000 Frm 00063 Fmt 6633 Sfmt 6633 C:\DOCS\35338.TXT HGOVREF1 PsN: HGOVREF1
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curate 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.

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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.

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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

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mulations, 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.

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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

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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

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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 walkin 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

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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

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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.

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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 drugaddicted 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

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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.

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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.

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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-YEAROLD 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.

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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 21⁄2

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

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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-thecounter 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 prepharmacy 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.

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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

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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

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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

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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

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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

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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-thecounter 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;

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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.

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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.

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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.

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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

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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 grandstanding. You shouldn’t be involved in this process; it is none of

your business.

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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

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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.]

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