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24–947 PDF 2005

OXYCONTIN AND BEYOND: EXAMINING THE ROLE

OF FDA AND DEA IN REGULATING PRESCRIPTION PAINKILLERS

HEARING

BEFORE THE

SUBCOMMITTEE ON REGULATORY AFFAIRS

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

SEPTEMBER 13, 2005

Serial No. 109–100

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

GINNY BROWN-WAITE, Florida

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

——— ———

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)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

SUBCOMMITTEE ON REGULATORY AFFAIRS

CANDICE S. MILLER, Michigan, Chairman

GINNY BROWN-WAITE, Florida

CHRIS CANNON, Utah

MICHAEL R. TURNER, Ohio

LYNN A. WESTMORELAND, Georgia

STEPHEN F. LYNCH, Massachusetts

WM. LACY CLAY, Missouri

CHRIS VAN HOLLEN, Maryland

EX OFFICIO

TOM DAVIS, Virginia HENRY A. WAXMAN, California

ED SCHROCK, Staff Director

DENA KOZANAS, Counsel

ALEX COOPER, Clerk

KRISTA BOYD, Minority Cousel

(III)

C O N T E N T S

Page

Hearing held on September 13, 2005 ..................................................................... 1

Statement of:

Meyer, Robert, Director, Office of Drug Evaluation II, Center for Drug

Evaluation and Research, U.S. Food and Drug Administration; and

Joseph Rannazzisi, Deputy Chief of Enforcement Operations and Acting Deputy Assistant Administrator, Office of Diversion Control, Drug

Enforcement Agency ..................................................................................... 21

Meyer, Robert ............................................................................................ 21

Rannazzisi, Joseph .................................................................................... 40

Tolman, Steven A., Massachusetts State Senator; Brian Wallace, Massachusetts State Representative; John McGahan, executive director,

Cushing House; and Janet L. Abrahm, co-director, Pain and Palliative

Care Programs, Dana Farber Cancer Institute and Brigham and Women’s Hospital, and associate professor of medicine and anesthesia, Harvard Medical School ...................................................................................... 59

Abrahm, Janet L. ...................................................................................... 79

McGahan, John .......................................................................................... 71

Tolman, Steven A. ..................................................................................... 59

Wallace, Brian ........................................................................................... 65

Letters, statements, etc., submitted for the record by:

Abrahm, Janet L., co-director, Pain and Palliative Care Programs, Dana

Farber Cancer Institute and Brigham and Women’s Hospital, and associate professor of medicine and anesthesia, Harvard Medical School,

prepared statement of ................................................................................... 82

Lynch, Hon. Stephen F., a Representative in Congress from the State

of Massachusetts, prepared statement of ................................................... 13

McGahan, John, executive director, Cushing House, prepared statement

of ..................................................................................................................... 75

Meyer, Robert, Director, Office of Drug Evaluation II, Center for Drug

Evaluation and Research, U.S. Food and Drug Administration, prepared statement of ........................................................................................ 25

Miller, Hon. Candice S., a Representative in Congress from the State

of Michigan, prepared statement of ............................................................. 4

Rannazzisi, Joseph, Deputy Chief of Enforcement Operations and Acting

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Agency, prepared statement of ................................................... 43

Tolman, Steven A., Massachusetts State Senator, prepared statement

of ..................................................................................................................... 63

Wallace, Brian, Massachusetts State Representative, prepared statement

of ..................................................................................................................... 68

(1)

OXYCONTIN AND BEYOND: EXAMINING THE

ROLE OF FDA AND DEA IN REGULATING

PRESCRIPTION PAINKILLERS

TUESDAY, SEPTEMBER 13, 2005

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON REGULATORY AFFAIRS,

COMMITTEE ON GOVERNMENT REFORM,

Boston, MA.

The subcommittee met, pursuant to notice, at 11 a.m., in Oliver

Wendell Holmes Courtroom #2, Supreme Judicial Court of Suffolk

County, Boston, MA, Hon. Candice Miller (chairwoman of the subcommittee) presiding.

Present: Representatives Miller, Tierney, and Lynch.

Staff present: Edward Schrock, staff director; Dena Kozanas,

counsel; Alex Cooper, clerk; and Krista Boyd, minority counsel.

Ms. MILLER. Good morning. I’d like to call the hearing to order.

I want to welcome everyone here this morning. This is a very, very

unique and historic occasion I think as well, and very appropriately

so, since we are in such a historic setting here in this courtroom.

The courtroom, apparently, was at one time used by Oliver Wendell

Holmes, as we were hearing from the court clerk this morning, and

this is really a historic jewel and treasure, certainly not only for

the people in Boston, but our entire Nation I think.

And, actually, before I got this job as a Member of Congress, my

former job was Secretary of State in Michigan, where I had an odd

appendage of those duties and responsibilities of being my State official historian. So, I’m very big on historic renovation and restoration, and it is wonderful, and hats off to the people of Boston that

they invested their capital in making sure that they preserve a

place like this for future generations. It’s very, very important for

that to happen certainly.

And, if you see anyone taking my picture during this it is because my husband is also a judge, and I have to make sure he sees

a picture of me sitting in a courtroom like this, a little bit different

than the courtroom that he has. But, we are here today on very serious business. As I say it’s a historic thing where we are really

attempting to bring Washington out of the Beltway and to where

a lot of the decisions are made on very important issues. We are

here today to examine the regulatory relationship between the U.S.

Food and Drug Administration and the Drug Enforcement Agency

in regulating Schedule II prescription painkillers, specifically

known as opioid analgesics, such as OxyContin.

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And, I certainly want to thank my colleague, Representative

Lynch, who is the ranking member of this subcommittee, for bringing such an important issue to our attention. I certainly appreciate

the devotion and the passion that he has shown to this issue, and

to so many others, and to the city of Boston by requesting actually

that our subcommittee travel here. He and I talked about the possibility of doing something like this for the last number of months,

and tried to work out all the dynamics of it, but I think it is very

important that we do bring these kinds of issues that sometimes

can get—we have so many things going on in Washington it’s difficult to focus sometimes on a particular issue. And so, I certainly

want to thank him for making sure that we do get out Boston and

talk about this, because it is such a huge problem here.

The abuse of prescription drugs is certainly not a new phenomenon. However, the problem of abuse and diversion of such drugs

has become increasingly more noticeable. Addiction and overdoses

to prescription drugs are receiving more attention, particularly in

the aftermath of OxyContin.

There is a dichotomy with prescription drugs. On one hand, these

drugs have a very legitimate medical use, and may be the only possible relief, quite frankly, for patients suffering from chronic pain,

such as cancer patients. But then, on the other hand these drugs

are very dangerous, and even deadly when they are misused or exploited.

Some people will suggest sometimes that drug companies, perhaps, have too much of an influence in Washington, DC, and that

they are protected because of that influence. And, quite frankly,

there is a choking grain of truth to that, I believe. In fact, in my

home State of Michigan we share a common border with the Nation

of Canada, so many of our residents are often going across the border to avail themselves of much cheaper drugs. Canadian citizens

pay a much cheaper price for many drugs than they do in America,

and so I have been on the opposite end of the equation as well with

drug companies on the issue of reimportation.

But, in this particular instance, I think, perhaps, there’s no one

person or group that can be blamed for this epidemic. The abuser

of painkilling drugs is, I think, a true test for us, trying to find a

sense of balance for all the different parties who are involved, the

government, the medical community, and the pharmaceutical industry as well.

The FDA and the DEA are two agencies responsible for regulating prescription painkillers. The FDA has the job of testing new

drugs and specifying how the drug may be marketed, prescribed

and used. The DEA is responsible for monitoring the distribution

and prescription of these drugs to prevent their illegal use. And,

many times the FDA and the DEA are an effective duo in fighting

the war against prescription painkiller abuse, but then there are

also times when the FDA and the DEA would benefit from a

stronger relationship.

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So, I’m looking forward to hearing the exchange of ideas today,

so that we may, hopefully, find some new approaches to the problem of prescription painkiller abuse and diversion.

At this time, I’d certainly like to recognize my distinguished colleague, Representative Lynch, for his opening statement.

[The prepared statement of Hon. Candice S. Miller follows:]

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Mr. LYNCH. Thank you, Madam Chair.

First, I’d like to begin by thanking the clerk of the SJC, Maura

Doyle, who has so graciously offered us the use of this beautiful

courtroom for the conduct of this hearing. Maura is a dear friend,

and she’s done a wonderful job here in the court, and I think that

the grace and the beauty of this courtroom is a reflection of her

hard work.

I remember not too long ago fighting for the Courthouses Bond

Bill that actually got a lot of this work done, and it really is, as

Chairman Miller has said, it’s a jewel, it’s a real treasure, and it’s

great to see the historic preservation here in this room, and I think

it lends credibility to all the acts that go on here, and, hopefully,

that will continue today.

I want to thank as well the citizens of Massachusetts, because

this is truly their building.

As well, I’d like to begin by welcoming Chairman Candice Miller

to the 9th Congressional District here in Boston. Madam Chair, I

thank you for your willingness to travel here to Boston and agreeing to hold this important field hearing.

This is an example of bipartisanship. There is much in the press

about the fighting, the squabbling, between Democrats and Republicans in Washington, DC. What you don’t hear is the work that

goes on together when we, as Members of Congress and as Americans, recognize that there’s a problem that needs to be worked on.

And, in that spirit we are here today, and we are joined as well

by my esteemed colleague, Representative John Tierney, who originally served on this Government Reform Committee. He has since

moved to the powerful Intelligence Committee, but he has left me

behind to carry on some of the priorities that he established when

he was on the committee, and he has been a mentor to me since

arriving in Congress and I appreciate his friendship and his participation here today.

The focus of this hearing is entitled, ‘‘OxyContin and Beyond: Examining the Role of the Food and Drug Administration and the

Drug Enforcement Agency in Regulating Prescription Painkillers.’’

I think it’s important at the very outset to clarify that this hearing

is not just about any particular piece of legislation. Rather, we are

here to examine the recently amended and accelerated FDA drug

approval process that has somehow allowed a series of drugs to

come onto the market, to make their way to our pharmacies, only

to be removed by either the force of litigation or government pressure after fatalities and widespread injury to consumers.

Unfortunately, we have a lot of examples of that. We have the

examples of Vioxx, the Cox II inhibitor, with 27,000 heart attacks

and sudden cardiac deaths before it was eventually pulled from the

market. But, it received FDA approval.

The example of ephedra, an appetite suppressant, with 1,000 reports of serious health complications for its use in at least 100

ephedra-related deaths, also which received FDA approval.

OxyContin, produced by Purdue Pharma, with hundreds dead

from overdose and thousands, perhaps, tens of thousands, hopelessly addicted, and that’s based on 2002 data, and most recently

Palladone, a potent narcotic painkiller twice as powerful as

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OxyContin, and also produced by Purdue Pharma, which was

pulled from the market 9 months after its initial FDA approval.

These developments, in and of themselves, would be serious, but

it’s important to note that in the case of Purdue Pharma a Federal

Appeals Court has recently ruled that their patent rights are invalid because, specifically, Purdue Pharma had lied to the U.S. Patent and Trademark Office on its original application for OxyContin.

The revocation of the exclusive patent rights ironically will now

allow other pharmaceutical companies to produce generic versions

of OxyContin, which will result in a wider availability and, therefore, greater potential for abuse.

This issue, like most for legislators, came to my attention

through our local experience with OxyContin. We are here today

because too many people in our communities and neighborhoods

are struggling with the problem of prescription painkiller abuse, as

well as the misprescription of these drugs, most notably

OxyContin.

According to a recent survey, OxyContin abuse was second only

to heroin, second only to heroin, as the drug abuse among patients

in non-methadone treatment programs in Boston. However, this

problem is not just confined to this city, and it’s not just a problem

impacting the inner cities of our Nation. Rural communities such

as Maine, West Virginia, Kentucky, as well as suburban communities from Arizona to Ohio, are all grappling with the problem of

OxyContin abuse and diversion.

In 2003, an estimated 2.8 million Americans has at some point

in their lives used OxyContin for non-medical purposes, a significant increase from the 1.9 million in 2002.

We are also very much aware that narcotic painkillers, such as

OxyContin, can be used successfully by chronic pain sufferers, including cancer patients to relieve pain. In fact, Purdue Pharma

originally presented the drug as being specifically targeted for cancer patients and severe and chronic pain sufferers.

I find it remarkable that this drug was put on the market without any study pointing to its addictive properties, which leads to

the underlying question we have for the FDA and the DEA. Knowing the power of these drugs, knowing the pervasiveness of modern

marketing techniques, and also taking into consideration the astounding profit motive for drugs that create, literally, customers for

life, the question to us is, how addictive will we allow these drugs

to become and still be legally marketed.

Also, there is a compounding difficulty here in the fact that absent the significant number of deaths related to these drugs, such

as we have had with Vioxx, ephedra, and I’d argue OxyContin, once

a drug receives approval through the FDA process it is virtually

impossible to require further research to improve its safety. That

condition, in itself, leads legislators to an inescapable conclusion

where the only option we have is to recommend the banning of that

pharmaceutical, and admittedly, that is not the ideal solution.

However, much remains unknown about those accidental addicts,

patients who are legitimately prescribed narcotic painkillers such

as OxyContin by their doctors and yet become addicted. The story

of OxyContin, its approval from the FDA, its marketing strategy,

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and its abuse and diversion, all illustrate the inability of our current regulatory framework to appropriately address the problem.

This problem is inherent in controlled substances, because their

active ingredient is OxyContin, oxycodone was a known quantity to

the FDA. Oxycodone was not given any special consideration with

regard to its potential for abuse and diversion during its approval

process.

OxyContin and Purdue Pharma understood a drug approval process that examines its safety and efficacy when used as directed,

therefore, the FDA, the DEA, physicians and patients who are

caught unaware of the addictive potential of this drug and its attraction to those who would abuse it.

I believe that there are several concrete ways in which this issue

can be addressed through the regulatory process and by legislation

if necessary. It’s my hope and expectation that through this field

hearing we can explore possible avenues on the Federal level, as

well as the State level, to address the overarching problem.

We know the significant growth in the use of OxyContin to treat

patients suffering from chronic pain has been accompanied by

widespread reports of abuse and diversion that have devastated individuals and their families, and in some cases have led to death.

However, the concern around OxyContin is about both those abusing the drug and those who are breaking the law to gain access to

the drug, but also to those individuals who are legally prescribed

the drug for pain control but became addicted.

Before the product OxyContin ever came to the commercial market, the manufacturer, Purdue Pharma, recognized its potential

blockbuster status. However, when Purdue Pharma began to expand the market for OxyContin to include patients who suffered

from non-cancerous, moderate to severe, acute and chronic pain

from broken bones, dental pain and lower back pain, we began to

see the consequences of Purdue Pharma’s irresponsible marketing.

Frankly, as this drug was prescribed more and more, we began to

see more and more addiction.

Not enough is known to date about the phenomenon of addiction

that is the result of medical care, and yet an alarming number of

patients may be becoming addicted, specifically, to prescription

pain medication after legitimately receiving a prescription for such

treatment.

According to a 2004 survey conducted by the Opiate Dependency

Treatment Center, the world renowned Weissman Institute in California, 44 percent of the respondents there dependent on

OxyContin were initially prescribed that by a physician. We simply

need a better understanding of the science of addiction to ensure

that patients and doctors have all the information necessary to

move forward with appropriate treatment plans.

Moreover, comparative studies are needed to assess the relative

addictiveness, efficacy and safety of available drugs. Although undoubtedly much good clinical science is undertaken in drug trials

done by pharmaceutical companies, it is also true that there are too

many opportunities in the current system for manipulation. As a

result, medicines may come on the market before they have been

properly vetted, or without having enough information to provide

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to patients and to doctors, specifically, about a drug’s potential for

abuse and addiction.

For instance, we have much to learn from our recent experience

with the drug Palladone, a potent narcotic painkiller which is twice

as powerful as OxyContin. On September 24, 2004, the FDA approved Palladone, a new 24-hour extended release, morphine-based

medication with a high potential for abuse. The FDA said it incorporated elements from the National Control Strategy into the approval process for Palladone.

For example, the FDA required the inclusion of a black box

warning on the drug’s label and medication guide. Additionally, the

FDA required the manufacturer to implement a Palladone risk

management plan. However, less than 9 months after its initial approval, on July 13, 2005, Palladone was abruptly withdrawn from

the market by the FDA, because of evidence that the drug’s interaction with even minor amounts of alcohol in the patient’s system

could lead to death.

It is also noteworthy that Palladone had been approved by the

FDA in September 2004, and yet the FDA stated it did not receive

adequate data from the Purdue Pharma company until later, which

ultimately led to the drug’s withdrawal from the marketplace.

Because Purdue Pharma is responsible for undertaking clinical

trials and then picks and chooses the data it presents to the FDA

for approval, problems can arise after a drug has already been approved and marketed. Many times the problem is not uncovered

until the drug is exposed to thousands of patients who report adverse reactions.

Thankfully, in the case of Palladone previous data highlighted

the problem so that there were no reported adverse reactions in the

patient population. The potential for harm illustrated by this case

is enormous. It is clear that the FDA, the DEA, and Congress, need

to do a better job in this area.

As described earlier, OxyContin addiction and abuse has severely

affected my district and the people I represent, as well as many

communities nationwide. The experiences of the FDA and the DEA

in regulating OxyContin and other Class 2 controlled substances

provides us with a powerful case study.

Although both the FDA and the DEA learned many valuable lessons from the OxyContin experience, it is clear that there is more

that can be accomplished through the regulatory process.

I look forward today to hearing from Doctor Robert J. Meyer

from the FDA, and Joseph Rannazzisi from the DEA about their

experience with OxyContin and how they are applying those lessons. Additionally, we have the distinct honor of hearing from two

outspoken leaders and energetic advocates of the people I represent

in my friend Steven Tolman who is here from Watertown, and my

dear friend and neighbor Representative Brian Wallace from south

Boston. I look forward to hearing both their perspectives as State

leaders on how they’ve addressed the issue of prescription painkiller abuse, specifically, OxyContin.

Also, Doctor Janet L. Abrahm from the Dana Farber Cancer Institute is here, representing the American Cancer Society, to explain to us how these powerful drugs benefit the patients she sees

every day. I know Doctor Abrahm will want to work with us here

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on the committee to ensure that her patients have access to the

pharmaceuticals they need, but are also protected from harm.

And finally, my good friend John McGahan is here to talk about

the work he does with the Gavin Foundation and the adolescents

and families here at the Cushing House in south Boston. These two

community institutions have been working non-stop to treat men

and women, young and old, who are addicted to drugs and alcohol.

It is my understanding that of the 16 beds that are at the Cushing

House, which is a residential rehab facility for adolescents, of those

16 beds all 16 are now occupied by adolescents who are currently

addicted to heroin, but who have been led to that addiction by a

previous addiction to OxyContin, which is a troubling statistic.

I think we’ll all find the testimony disturbing but enlightening.

Once again, I want to thank everyone for attending this hearing

today, I really do believe that together we can come up with some

potential legislative and regulatory fixes on the Federal level that

will keep our communities, and our families, and our children safe.

Thank you again, Madam Chair, for recognizing the importance

of this topic, and for attending today’s hearing. I yield back.

[The prepared statement of Hon. Stephen Lynch follows:]

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Ms. MILLER. Thank you.

At this time, I’d like to recognize our other distinguished colleague who joins us today, Representative Tierney, for his opening

statement.

Mr. TIERNEY. Thank you, Chairman Miller, and I want to thank

you for coming down from Michigan, or over from Michigan, to

share this hearing with us, and Ranking Member Stephen Lynch,

thank you both for inviting me to join you this morning. I am on

a leave of absence from this committee, and temporarily over with

the Intelligence Committee at their request, but I’m happy to be

back with my colleagues, particularly dealing with a matter of import such as this, one that’s affecting all of our districts.

And, as Congressman Lynch indicated, it’s not just OxyContin,

it’s the fact that OxyContin is so often, at least in our communities,

leading to heroin addiction, where we were discussing earlier

where district attorneys tell us that people are buying the

OxyContin at about $80 a shot, but finding they get a free bit of

heroin involved in that, so that when they run out of money for the

OxyContin they can switch over to the heroins. Dealers are certainly at no loss for ways to get new customers, and this is difficult.

So, the issue is, how do we identify and provide for the treatment

of both that’s both chronic and acute, while still preventing the

abuse of opiates that lead to a range of social problems.

One side, obviously, is the argument that the opiate analgesics

are essential to the treatment of acute pain due to trauma and surgery, and the chronic pain, whether it’s due to cancer or non-cancerous origins, and we all have great sympathy for people in that

situation, understand the number of doctors and other healthcare

providers who insist that this is an essential treatment, but there’s

a wide range of evidence and communications that also point to

some legitimate concern, a very legitimate concern of families, law

enforcement officials, and, of course, health professionals themselves, who see the problem that we have with addiction and where

that leads us and our communities.

So, there are going to be a number of questions that I hope we

can get addressed and, perhaps, even answered today during the

course of this hearing.

We know that since 1998, that approximately 450 patents have

been filed by over 19 different companies that are attempting to

create an abuse-resistant formula for painkilling drugs, so-called

antagonists. Why is it taking so long? Should the government provide assistance, or should the government even conduct the research itself?

Sponsors for Schedule II controlled drugs are asked to consider

developing strategies for safety programs, why doesn’t the FDA require the pharmaceutical companies include those proactive risk

management plans in all new applications? Does it have the authority to do so, and would it be a wise thing for them to make that

happen?

We are very concerned to the dangers that occur from off-label

prescription drugs. Is it a fact that physicians are over prescribing

opiate analgesics? Would eliminating the off-label use of OxyContin

by requiring specific instructions on distribution, such as mandating that they be prescribed only to patients with cancer or terminal

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patients, in order to limit the amount of drugs being circulated,

thereby be helpful? What other regulatory actions could the FDA

take? Do they have the ability to require these drug companies

after the fact to take action? Is there a compliance time that they

could enforce? Are their deadlines and powers that the FDA has in

order to make them effective?

There are technologies, the so-called ‘‘radio frequency identification technology,’’ that would allow us to track these drugs as they

move through the supply chain. There are reports that in some instances there might be an interference with existing technologies

in hospitals that are other ways not able to be implemented. Is this

something we should be looking at? What’s the status of RFIT technology? Does the FDA support this technology, and how are they

going to make sure that its brought to the market faster if they do?

Programs that are being run through the Department of Education’s Office of Safe and Drug Free Schools and SAMHSA have

had somewhat successful track records of reducing substance

abuse. Many of those programs are geared to gateway drugs, such

as alcohol and marijuana. There’s no Federal program that we’ve

been able to find that specifically funds prescription drugs or opiate

analgesics education, prevention and treatment for students. It’s a

unique challenge, because many times, due to the fact that they

are prescribed, leads people to believe that they are also safe.

Would having current education awareness programming expand

to this area be helpful, and would it have some impact on the

abuse of prescription drugs among students?

Are there Federal guidelines for prescribing pain managements,

and would it be effective to institute them, and how would we go

about doing that?

And last, as the DEA collects data, can it use that data in a

proactive way and more effective way, and speak to the process

that’s used to analyze data collected from these and other sources?

Is our current process adequate or can we do better, and what

should we do?

All of these questions are outstanding for today’s hearing. I’m

thankful for the witnesses taking their time to join us here this

morning, and I know that what they have to say will help us graft,

hopefully, some Federal direction as to what we can do to, both

make sure that patients who are in need of treatment and pain relief will be satisfied, as well as will our social need, to make sure

that these opiates and other medications are not abused and do not

create the social problems that are now hitting our communities

rampantly.

So again, thanks to my colleagues for inviting me to join you

today. I think this is going to be a helpful hearing, and I look forward to the testimony by witnesses.

Ms. MILLER. Thank you.

Because the Government Reform Committee is an oversight committee with subpoena authority, we do have as a practice, even

when we are outside of Washington, to swear in all of our witnesses. So, if you could please rise, raise your right hands.

[Witnesses sworn.]

Ms. MILLER. Thank you, please be seated.

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Our first witness today that the subcommittee will hear from is

Doctor Robert Meyer. In 2002, Doctor Meyer was appointed Director of the Office of Drug Evaluation, at the Center for Drug Evaluation and Research, at the FDA. Prior to serving as Director, Doctor Meyer was a medical reviewer for the Division of Oncology and

Pulmonary Drug Products. Doctor Meyer also chairs the Agency’s

Risk Assessment Guidance Working Group, and he’s on the FDA

Drug Safety Oversight Board.

Doctor Meyer, we want to appreciate you for coming from Washington to Boston, and appreciate your testimony. The floor is yours,

sir.

STATEMENTS OF ROBERT MEYER, DIRECTOR, OFFICE OF

DRUG EVALUATION II, CENTER FOR DRUG EVALUATION

AND RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION;

AND JOSEPH RANNAZZISI, DEPUTY CHIEF OF ENFORCEMENT OPERATIONS AND ACTING DEPUTY ASSISTANT ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, DRUG ENFORCEMENT AGENCY

STATEMENT OF ROBERT MEYER

Mr. MEYER. Good morning, Madam Chair, and members of the

subcommittee.

I am Doctor Robert J. Meyer, Director of the Office of Drug Evaluation II, in the Center for Drug Evaluation and Research [CDER],

at FDA. I oversee CDER’s Division of Anesthetic, Analgesic and

Rheumanologic Drug Products, which has regulatory responsibility

for the opiate analgesic products, and I appreciate the opportunity

to speak to you today about our drug approval process and the role

that we have in preventing prescription drug abuse.

FDA is a Public Health agency, with a strong commitment to

promoting and protecting the public health by assuring that safe

and effective products reach the market in a timely way, and then

by monitoring for the safety of these products when they are in

use.

FDA is aware of and concerned about reports of prescription drug

abuse, misuse, and diversion. We are aware of data showing that

abuse of prescription drugs, including narcotics, has grown rapidly,

including the abuse of OxyContin. We understand the seriousness

of this issue, and sympathize with the families and friends of individuals who have lost their lives or otherwise been harmed as a result of prescription drug abuse or misuse.

We also sympathize with the many pain patients who often suffer needlessly, due to under treatment or substandard treatment.

On these matters, FDA must strike a critical balance. While addressing the very important issues of opiate abuse and misuse,

FDA must also act in a manner that assures patients who require

narcotics for adequate pain control have full, appropriate access to

them through informed providers.

Let me speak for a moment about FDA’s drug approval process.

Under the Food, Drug and Cosmetic Act, FDA is responsible for ensuring that all new drugs are safe and effective. Before any drug

is approved for marketing in the United States, FDA must decide

whether the studies and other information submitted by the sponVerDate 11-MAY-2000 10:37 Jul 12, 2006 Jkt 000000 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 D:\DOCS\24947.TXT HGOVREF1 PsN: HGOVREF1
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sor have adequately demonstrated that the drug is, indeed, safe

and effective for use according to the drug’s labeling.

Since no drug is without risk, FDA’s approval decisions always

involve an assessment of the benefits and risks for a particular

product and its proposed use. When the benefits of a drug are

found to outweigh the risks, and the labeling instructions allow for

safe and effective use, FDA approves the drug for marketing.

At the time of approval, and sometimes after approval, FDA may

develop, in cooperation with the drug sponsors, a plan of interventions beyond labeling to help assure the safe and effective use of

the drug. This has recently been referred to as risk management,

or risk minimization plans [RMPs], but this practice dates back

many years.

These interventions making up an RMP may be varied, but all

are aimed at assuring that some known or potential issues regarding the proper use of the drug are addressed by prescribers or patients using the drug.

During the approval process, FDA assesses a drug’s potential for

abuse. If a potential for abuse is found to exist, the product sponsor

is required to provide FDA with all the data pertinent to abuse of

the drug, a proposal for scheduling under the Controlled Substances Act, and data on overdoses.

Under the Controlled Substances Act [CSA], FDA notifies the

DEA that a new drug application has been submitted for a drug

that has either a stimulant, depressant or hallucinogenic effect on

the central nervous system, including opiates, because it is then assumed the drug has abuse potential. The FDA recommends a

scheduling category and the DEA makes the final scheduling category decision.

Finally, it’s important to state that FDA’s job is not over after

a drug is approved. The goal of FDA’s post-marketing surveillance

is to continue to monitor marketed drugs for safety, and this is accomplished by reassessing drug risk based on new data learned

after the drug is marketed, and when needed by recommending

ways to manage that risk.

Let me speak specifically to the approval and regulatory history

of OxyContin. OxyContin is a narcotic drug that was approved by

FDA for treatment of moderate to severe pain on December 12,

1995. At the time of approval, the abuse potential for OxyContin

was considered by FDA to be no greater than other Schedule II

Opiate analgesics that were already marketed in the United States,

Schedule II being the highest level of control for a legally marketed

medical product.

FDA was aware that crushing the controlled-release tablet, followed by intravenous injection of the tablet’s contents, could result

in a lethal overdose. A warning against crushing the tablet was included in the approved labeling, but FDA did not fully anticipate

that crushing or otherwise subverting the controlled-release capsule, followed by oral ingestion, intravenous injection, or snorting,

would become so widespread and lead to a high level of abuse.

In response to reports of abuse and misuse of OxyContin, FDA

worked with Purdue Pharma to develop a risk management program. The program included adding stronger warnings to

OxyContin’s labeling, educating healthcare professionals and their

23

sales staff, and developing a tracking system to identify and monitor abuse.

In July 2001, the warnings and precautions section in the labeling of OxyContin were significantly strengthened. This labeling

now includes a boxed, bolded warning, sometimes called a black

box, the highest level of warning for an FDA-approved product.

OxyContin’s boxed warning informs patients and physicians

about the drug’s abuse potential, that OxyContin is only for patients with chronic pain, of sufficient severity that requires a controlled-release opiate, and warns about the potentially lethal consequences of crushing the controlled-release tablets.

The indication for use was clarified to reflect that it is approved

for the treatment of moderate to severe pain in patients who require around-the-clock narcotics for an extended period.

Let me speak briefly about FDA’s collaborative efforts with other

entities, including FDA’s efforts to address the diversion and illegal

sales of approved controlled substances. FDA has met and will continue to meet with a number of government agencies, industry and

professional groups, to share information and incites needed to address the broad problem of prescription drug abuse that goes beyond the scope of any single organization. For instance, FDA and

DEA have met repeatedly to discuss further ways to prevent prescription drug abuse and diversion. In addition to assisting one another with criminal investigations, both agencies have worked together on initiatives in the following areas: State prescription drug

monitoring programs; a joint task force participation focused on illegal sale of controlled prescription drugs; and the assessment of

new products with abuse potential.

FDA’s enforcement efforts aimed at addressing diversion and illegal sales of approved controlled substances, including opiates like

oxycodone, have grown in recent years, while the DEA is the appropriate lead Federal agency responsible for regulating controlled

substances and enforcing the Controlled Substances Act, the complexity of the cases and the solutions to the problems of misuse,

and overdose, and diversion of prescription drugs, and especially of

high concentration opiate analgesic drugs, often benefits from the

collaboration of DEA and FDA, as well as State and non-governmental entities.

The FDA’s Office of Criminal Investigation is working closely

with DEA on criminal investigations involving the illegal sale, use

and diversion of controlled substances, including illegal sales over

the Internet.

In conclusion, FDA recognizes the serious problem of prescription

drug abuse. The agency has taken many steps to address the serious problem, and will continue to act to curb abuse, misuse, and

diversion of prescription drugs.

Since this is a problem that is broad in its reach and implications, we are also committed to collaborating with our partners,

Federal, State and local officials, professional societies and the industry, to help prevent abuse and ensure that these important

drugs remain available to the appropriate patients.

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We share the subcommittee’s interest and concerns regarding

prescription drug abuse, and would be happy to answer questions.

Thank you.

[The prepared statement of Doctor Meyer follows:]

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Ms. MILLER. Thank you, Doctor Meyer.

Our next witness is Mr. Joseph Rannazzisi. He is the Deputy

Chief of Enforcement Operations and the Acting Deputy Assistant

Administrator for the Office of Diversion Control at the DEA. He

graduated from Butler University with a degree in pharmacy, and

from Detroit College of Law at Michigan State University, go

green. He has been with the DEA since 1988, first working in Detroit, MI, and then moving to Washington, DC, in 2000.

In his position, Mr. Rannazzisi directs DEA’s efforts to prevent

the misuse and abuse of controlled substances. We want to thank

you for appearing today as well. We look forward to your testimony, sir.

STATEMENT OF JOSEPH RANNAZZISI

Mr. RANNAZZISI. Good morning, Chairman Miller, Ranking Member Lynch, Representative Tierney. I appreciate your invitation to

testify today on the status and efforts of the Food and Drug Administration and Drug Enforcement Administration in regulating

Schedule II opiates. The non-medical use of prescription drugs is

an increasingly serious problem, a new generation of high-dose, extended-release opioid pain medications is producing alarming abuse

and diversion statistics, and are creating new challenges for law

enforcement. While these new drugs are proven effective in the

treatment of chronic pain, they also offer equally increasing risks

of abuse and——

Ms. MILLER. Excuse me, could you speak up a little closer to the

mic? We are having difficulty hearing you, sir.

Mr. RANNAZZISI. Yes, ma’am.

Ms. MILLER. Thank you.

Mr. RANNAZZISI. OxyContin, Duragesic, and other Schedule II

opioids are examples of the drugs most divertable. The potency, purity and quantity of their active ingredients make them more dangerous than ever, providing powerful temptation for abuse. They

also encourage new means of diversion, such as ‘‘rogue’’ Internet

pharmacies. DEA is taking aggressive action against the threat

with our OxyContin National Action Plan.

Boston has an OxyContin problem. DEA investigations show that

oxycodone products, such as Percocet, Roxicet, OxyContin, are readily available in Massachusetts. Shipments of OxyContin have been

diverted from legitimate distributors. We have seen well-organized

doctor shopping rings, individuals that forge or alter prescriptions,

and diversion from legitimate prescriptions. Demand has fueled organization distribution.

Now, regulatory control is vital to addressing this problem. Currently, DEA establishes and enforces quotas for Schedule I and II

substances, ensuring an adequate uninterrupted supply of controlled substance, both legitimate and medical, and scientific needs,

while limiting the amount available for diversion. DEA is also a

strong proponent of the State prescription drug monitoring programs, that collect prescription information electronically from

pharmacies, to assist in the identification of doctor shoppers and

over prescribers. Recently, Federal oversight of the prescription

drug monitoring plans was transferred to the Department of

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Health and Human Services. DEA looks forward to working with

HHS as they take the lead on this effort.

DEA, with DOJ, ONDCP, FDA, and other law enforcement and

community partners, have instituted comprehensive initiatives in

support of the National Drug Control Strategy. For example, DEA

supports the National Strategy through education and recently

launched a Web site, www.justthinktwice.com, to provide teens

with information on consequences of drug abuse traffic. We’ve developed public service announcements to appear during Internet

prescription drug searches. We are meeting with leading certifying

medical boards and encouraging them to develop educational programs concerning the prescribing of controlled substances.

DEA supports the National Strategy’s tactic to ensure that treatment resources go where they are needed. Our controlled substances quota is provided for adequate, uninterrupted supplies of

treatment drugs, while limiting the amount available for diversion.

We also issue registration numbers to physicians who possess waivers to provide opioid addiction treatment within their offices.

The National Strategy targets the economic basis of the drug

trade, and we have placed a strong emphasis on seizing the revenue generated by drug traffickers. DEA registrants in violation of

regulatory requirements are also subject to significant civil fines,

a proven deterrent.

The subcommittee expressed interest in the radio frequency identification security tagging. A detector alerts for bottles taken, but

pills may be removed from that bottle. Although almost all the prescription drugs we see are no longer in commercial containers, and

we rarely see counterfeited versions of controlled substances. We

will continue to monitor and evaluate the usefulness of this technology.

DEA continues to develop new enforcement strategies to address

controlled substance diversion and abuse. We are increasing the

number of our priority target investigations. We are creating tactical diversion squads throughout the country. We are developing

a comprehensive strategy for illicit online pharmaceutical sales,

and have created a specialized training seminar for assisting U.S.

attorneys on diversion prosecutions.

We are also educating the medical community and drug industry

and providing prescription drug information, resources and training to State and local government officials, groups, students, and

the general public. We have established an international toll-free,

24-hour tip line, 1–877-RXABUSE, a new Web site,

justthinktwice.com and the dea.gov Web site, public service announcements via the internet and e-commerce and e-prescribing

initiatives.

DEA is addressing opioid abuse on many fronts. We seek to work

with FDA and other agencies to reduce the diversion and abuse of

these drugs, while ensuring that a sufficient supply exists to meet

the legitimate medical needs.

DEA is vigorously executing the 2005 National Drug Control

Strategy, remaining abreast of cutting edge technologies, and actively seeking new approaches to prevent the diversion of legitimate pharmaceuticals.

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I want to thank you for your recognition of this important issue,

and the opportunity to testify here today. I’ll be happy to answer

any of your questions.

[The prepared statement of Mr. Rannazzisi follows:]

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Ms. MILLER. Thank you.

I appreciate both of your testimony.

Taking a few notes as you were speaking here, and I suppose I’d

like an answer from both witnesses on this, if I could.

Doctor Meyer, you were speaking about labeling of OxyContin,

and we actually have some written testimony here that’s been

given to the subcommittee from Purdue Pharma, in which they’ve

actually shown us a copy of the box warning that you spoke of,

about the labeling on this. I won’t read it all to the audience here,

but it is a very black box that apparently appears, OxyContin is

an opiate agonist and a Schedule II controlled substance with an

abuse liability similar to morphine, etc. It goes on about the controlled release, oral formulation, etc.

So, it would seem to any physician or whomever that the labeling

is very clear about the dangers of this particular drug. How do you

think that the marketing of OxyContin is actually circumventing

what is a very clear labeling?

And again, if I could have a response from both witnesses, I’d appreciate that.

Mr. MEYER. Let me say one other thing with regard to the labeling, because it’s important to realize that the labeling does inform

how the drug is marketed, in terms of print ads and so on. And,

in fact, the FDA has issued warning letters in the past for infractions of that, including to Purdue Pharma.

I’m personally unaware of any concerted effort to circumvent that

kind of boxed warning, but it is a concern to FDA that despite

these kind of warnings, and this goes beyond just OxyContin, the

boxed warning is as high a warning as we can give a drug, and

they are very prominent in the labeling when you look at it.

Nonetheless, it only goes so far in informing physicians, and I

think from my standpoint it’s a very important tool to inform physicians about proper use of the drug, but, unfortunately, it’s not always heeded.

Ms. MILLER. Mr. Rannazzisi.

Mr. RANNAZZISI. As far as the marketing practices, I believe you

have to look back from when the drug was released in the mid

1990’s.

Ms. MILLER. Could you get by the mic, I’m sorry, I can’t hear you

again.

Mr. RANNAZZISI. Oh, I’m sorry.

I believe you have to look back to when the drug was initially

marketed in the mid 1990’s. Physicians generally rely on what they

are told about the drugs from the salesmen that are selling those

drugs.

I don’t believe that the physicians were adequately notified of

what the drug could actually do, and what specific patient population that drug should be targeted toward. And, I think listening

to Mr. Lynch and Mr. Tierney, I believe that the doctors, since they

didn’t know what they had at the time, they maybe prescribed to

people that didn’t necessarily need the drug, and I think that was

a problem.

Ms. MILLER. Doctor Meyer, you had also mentioned about risk

management plans [RMPs] as you called them. I’m wondering, are

risk management plans always required by the FDA as part of

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your approval process, and if so under what authority would that

happen? Is it part of statute? Is it a promulgated rule from the

FDA? This being a regulatory subcommittee, we’re particularly interested in how you did the construct for that. And, as well, if it

is, if they have been under that type of a thing, as Representative

Lynch mentioned in his opening statement we are now seeing these

generic forms of these drugs. Are the generics also forced into the

same type of regulatory process under the risk management plan

as the original drug was?

Mr. MEYER. When you said does this apply to all drugs, it does

not apply to all drugs, but it is our intention, and it’s actually our

statement in guidance, including some of the recent risk management guidances that were released by the agency, that all potent

opiate products would have a risk management plan at the time of

their approval.

That is not under specific authority of the FD&C, it’s an expectation of the FDA, we work in cooperation with the sponsors to

achieve that, and it would apply, and has applied, to the generic

drugs as well.

Ms. MILLER. The final question then, is this something that Congress could help you with? Is there something that Congress could

do to assist you legislatively, to give you the tools that you need

to make sure that is part of the process? I mean, that’s really what

the purpose of this hearing is today, is so that we can understand

better what exactly we can do to give you the tools you need to

help.

Mr. MEYER. Understood. I don’t believe the administration has

taken a position on that matter, so I don’t think I could express an

opinion. But, you know, as I said, it is not part of the FD&C authority at this point.

Ms. MILLER. Thank you.

I yield to Representative Lynch.

Mr. LYNCH. Thank you, very much.

First of all, I want to thank both of you gentlemen for coming

here and offering your assistance to the committee.

Let me begin just by sort of touching on a couple of issues that

Madam Chair touched on, and I’m particularly interested in your

response, Doctor Meyer.

You mentioned that based on the wording in the label you saw

no evidence of anybody trying to undermine the warning on the

black box itself.

Mr. MEYER. I said I was unaware of any concerted effort in that

regard.

Mr. LYNCH. Any concerted effort.

Mr. MEYER. Yes.

Mr. LYNCH. But, your agency, the FDA, it actually, first of all,

they report that Purdue Pharma spent more than any other drug

in history, in marketing their drug, more than any drug in history.

Your agency found that they had two misleading advertising

campaigns. You cited them. The FDA cited them, gave them warning letters.

One, they had an ad with two guys fishing, and, you know, there

was the arthritis, they were pushing OxyContin for the treatment

of arthritis. That would seem to be an ad campaign by a company,

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in my opinion, to push a drug for people for whom it is inappropriate, and that’s what your agency said. The claim was that the

treatment of arthritis was completely unsubstantiated, those are

your words, your warning letter to the company itself.

Mr. MEYER. Yes.

Mr. LYNCH. So, to sit here today and to say—and that’s just one

of them, there’s another warning letter, there are two different ad

campaigns by the company where they inappropriately marketed

this thing.

Mr. MEYER. Right.

Mr. LYNCH. This is not a couple of rogue drug detailers who are

out there on their own, this is the company, and getting a warning

letter from your agency, the FDA, should be a serious event. And

yet, even though you warned them twice, you don’t think there was

any effort to undermine the warning on the label, which doesn’t

even speak to the issue of addiction, it talks about the potential for

abuse, which is another matter.

Mr. MEYER. Well again, when I answered the question I also

pointed to those warning letters, but aggressive marketing does not

necessarily equal illegal or inappropriate marketing, and this drug

was aggressively marketed, no doubt about it. But again, out of all

that marketing there were only two ads that the agency found to

be violative.

Mr. LYNCH. Well, all I’m saying is, your statement was that you

saw no concerted effort to undermine the warning on the label, and

all I’m saying is, pushing it to people with arthritis, and doing it

in a way that you found to be misleading on two occasions, advertising campaigns by the company to push this drug for a purpose

for which it was not approved undermines the warning on the label

that says, it’s only for this purpose, and also we approved this with

certain caution.

Mr. MEYER. Right.

Mr. LYNCH. OK. It just overrides those cautions, and that’s the

one point I want to make.

Mr. MEYER. Understood, and the agency understood that as well,

which is why it issued the warning letters.

Mr. LYNCH. No, I’m happy you did. I’m happy you did. It seemed

to be—your statement seemed to be at odds with the evidence,

that’s all.

One of the question I had in reviewing sort of the way that the

DEA and the FDA work together, and it’s something that I think

having you both here will just help me to understand. If you could

both just take a minute, for the benefit of the committee, talk

about how—I know that the DEA is responsible for enforcing the

Controlled Substance Act, and that the FDA handles the application process, and getting it approved, and making sure that certain

studies are conducted when appropriate, but in the process itself at

what point, I know there’s a a lot that is in your hands, Doctor

Meyer, from the application process much earlier than the point at

which the DEA gets involved. Can you tell me when that overlap

occurs? When does the DEA get into that process on a drug like

OxyContin?

Mr. MEYER. Well, on a new drug that has not previously been

scheduled, it will occur toward the end of the review process, and

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the reason is for that, that the FDA at that point has gone through

all the requisite data on use potential, on issues of drug dependence, abuse liability, and so on, and we’ll put that together with a

recommendation that then goes through the Department for DEA’s

consideration the scheduling process.

Under a drug that’s already been scheduled, there may not be

formal interactions prior to the approval, with the exception of discussions about how the approval might impact on the—if it’s a

Schedule II drug, on the quota.

Mr. LYNCH. OK.

Was that, the latter example, that was the one with respect to

OxyContin, because oxycodone had already been out there, right?

Mr. MEYER. Correct.

Mr. LYNCH. OK.

So, let me turn to you, Mr. Rannazzisi, to your knowledge, what

was the interaction for this particular drug by the DEA?

Mr. RANNAZZISI. That was way before my time, however, as my

colleague said, I believe that was pretty much the process.

We get the information, the medical and scientific data, you

know, just, I guess, prior to approval, we run it through our scientists, our pharmacologists run medical and scientific data

through their vetting process, and we come to an agreement on if

it should be a controlled substance, and what schedule it should be

in, and we send it back and then it’s scheduled. That’s about it.

Mr. LYNCH. OK.

Let me just ask, I know, Doctor Meyer, in your testimony you

talked about the approval process and preventing abuse or diversion, if you will, of the drug once it is approved, and that’s a very

thorny issue because in some cases it is literally beyond the agency’s reach and it is unanticipated.

But, with respect to Palladone, now here was a situation where

there had been some concern regarding combination with alcohol in

the process. OxyContin had been out there for a while, and this

was certainly twice as powerful as OxyContin, and given the prevalence of alcohol within our society it is astounding to me, it is astounding that this Palladone got approval, this passed the FDA approval process when even based on your own testimony and what

I’ve got here before me today from the FDA that even a minor

amount, a relatively minor amount of alcohol, combined with

Palladone could be fatal.

And, if there’s anything that can be said on Purdue Pharma’s behalf today, at least they pulled it off the market. But, it troubles

me greatly that it got through, in terms of the FDA as a gatekeeper

to prevent harmful substances from getting out there and getting

approved, and getting on the shelves. The system failed with

Palladone, and then, you know, we sort of caught up. I don’t know

if the FDA had all the information it needed or what the problem

was, but I see a trend here. More and more powerful drugs, more

and more addictive drugs, and how addictive are we going to allow

these drugs to become? Even when properly prescribed, they are

just so powerful.

I know in your testimony you talked about oxycodone and how

it was out there in Percocet, Percodan, whatever it is, and there

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was somewhat an assumption this is more of the same, but that’s

not what I see in my community.

I had a young woman from a very good family come into my office and tell me that she had been prescribed OxyContin for dental

pain, and she had a refill, and she had a dependency within a very

short time. She went back to her dentist on two later occasions,

and she tells me now, she’s in rehab, she tells me now she lied to

her dentist on other teeth pain, had two more healthy teeth extracted just so she could get that prescription.

So, when somebody tells me it’s more of the same, oxycodone has

been out there, and that it’s nothing new, it’s at odds with the evidence, not only the anecdotal evidence from my district, but when

I travel throughout the State I have never in my life seen at every

single pharmacy, whether it’s in the city of Boston or on Cape Cod,

or in the Berkshires, every single pharmacy in the State has a big

sign in the front window, ‘‘We don’t sell OxyContin,’’ some in the

city of Boston, ‘‘We don’t carry OxyContin onsite,’’ because of the

number of robberies, they don’t want to get robbed, and I’ve never

seen that with Percodan, or Percocet, or any other medication. It

is astounding the power of this drug.

And, I’m just concerned, how could we have stopped Palladone

from getting through? I mean, you know, I’m all for more funding

for the FDA, and approving that process, or tightening up the studies that are necessary, and how can we help you to help us and

to be a better gatekeeper in terms of this whole process, because

it’s not just about the drugs we are talking about today, you know,

I’m fearful that this next generation, as Mr. Tierney mentioned, all

these applications out there, you know, there’s a real rush, we are

at a very exciting time, you know, in drug development, I think.

There are a lot of opportunities out there. There’s a lot of investment, and people pushing the envelope. How do we set up a system

that anticipates all of that, that power, and some of these drugs

that I’m afraid will make OxyContin look like aspirin in about 10

years, and that get out there in the public? How do we help you?

Mr. MEYER. That’s a fairly broad question. Let me turn to that

in a second.

I did want to make the point as far as the—you point to these

more potent products, and I understand your very real concern and

hear the tragic story that you relay, but I also understand that

there are pain patients out there for whom drugs like Percocet and

the short-acting opiates that have less potency do not properly relieve them. So, I think the tension for the pain community, the tension for the FDA, is trying to figure out how to properly address

both sides of this equation. We always keep that in mind, so I just

wanted to say that as the background.

As far as the situation with Palladone itself goes, that was marketed with the most stringent risk minimization program that we

had to date with a potent opiate product, and I think that in many

ways that was a good thing. We, I think, went as far as we felt

we could in terms of putting that in place, understanding the concerns, very real concerns about this drug from its abuse potential,

but also understanding its promise from a therapeutic potential.

The particular situation with this was that this formulation actually looked to be, in many respects, much less abusable than

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OxyContin. If it was crushed it didn’t release the way OxyContin

did.

Quite frankly, it was a regulatory learning from our standpoint

that something that in the laboratory could release drug in exposure to high amounts of alcohol could actually do that in the patient setting, and that’s why we took the action we did with Purdue’s ascension or agreement.

I think that for us, taking that regulatory learning and properly

applying it for every case into the future is a firm commitment on

our part. And so, I don’t think there’s a particular lesson there,

where, you know, more funding, more effort, in this specific regard

would have addressed that.

On the broader issue of how the agency can be helped, I think

that’s enough of a policy question that I would defer that to others.

I think if you’d like an answer to that in writing I’d be happy to

seek that from the agency, but I’m a little bit uncomfortable, from

my position as a physician rather than a policymaker, in answering

that.

Mr. LYNCH. Fair enough.

Before I turn to Mr. Rannazzisi again, I would just like to say,

do you think at least—it’s also remarkable to me that we never did,

with all the pain and suffering—with all the addiction I see, and

all the pain and suffering I see outside of the proper people that

should be receiving this drug, there has never been, to my knowledge, a study done on the addictive properties of OxyContin, on the

addiction itself, and I can find no study, I’ve asked the FDA if they

had any study, they said no, we don’t have a study on that, I think

that information could be tremendously useful to educate doctors

and patients that they say, OK, here’s the addiction rate, not the

abuse rate, but the actual addiction rate, what is the rate of addiction for people who actually get properly prescribed this drug for,

you know, a measured period of time? Do you think that such a

study would be helpful to the FDA in measuring the, I think, appropriateness of the drug itself?

Mr. MEYER. I think in general there’s an incomplete knowledge

of the relative—what some will call like-ability of a drug, of opiate

drugs, and how that compares amongst the drugs. It’s fairly good

data about the potency, in terms of their specific receptor actions

or pain actions, but there’s been less study in terms of the comparative abuse potential or like-ability of the drug. And, I think

that sort of data, not just to the FDA, but for other agencies and

other healthcare entities, would be useful data.

Mr. LYNCH. Right. I’m just talking about, for instance, right now

Purdue Pharma has—well, early on they said that someone on a

low dosage for a long period of time of OxyContin could be off it

with very little withdrawal in a couple days. Meanwhile, I’ve got—

and that someone could be on a higher dosage for a long period of

time and it would be a matter of a couple of weeks before they were

back to normal and would have no withdrawal effects.

And, I’ve got about 500 people on a waiting list for beds for residential treatment, you know, for the drug itself. So, I’m seeing a

great disparity between what they are telling us and what we are

seeing, and I think most people who run rehab clinics, you know,

if you try to tell them that someone can get off OxyContin after a

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long period of time in a matter of a couple of days, they’d just

laugh in your face. Same way with people that have been on the

drug for an extended number of, you know, weeks at a higher dosage, I just find it astounding.

And, I think if we had some data around that we might be able

to at least get a rate at which—and how long it took people to go

through the withdrawal process after being on the drug on average,

and I think we should really put it on some of these companies before they get their drug approved, especially when we’ve got the experience staring us in the face right now.

Ms. MILLER. If I could, Representative Lynch, Mr. Tierney has to

leave a little bit early, if I could recognize him.

Mr. LYNCH. Sure.

Ms. MILLER. And then, we’ll come back to you for a second round

of questions.

I recognize Representative Tierney.

Mr. TIERNEY. Thank you very much. I’ll try to be a bit brief, if

I can.

Doctor Meyer, you are familiar with the concept of an antagonist?

Mr. MEYER. Yes.

Mr. TIERNEY. Would you just briefly describe that for others?

Mr. MEYER. It’s, basically, a drug that blocks the receptor, so

that the agonist drug, in this case if you are talking about opiates,

the opiate receptor is blocked by this so that the agonist drug can’t

have its effect. It blocks, in effect.

Mr. TIERNEY. And, wasn’t that done with some of the morphinebased drugs a while back?

Mr. MEYER. It has been done. There’s actually two agonists that

are in common use, miloxydone and miltrexone.

Mr. TIERNEY. So, tell me why there’s 450 patents out there, 19

different companies that we’ve been able to track or whatever, that

are trying to create this antagonist situation of the abuse-resistant

formula for these drugs, why is it taking so long in this instance?

Mr. MEYER. Well, if you think about giving an antagonist at the

same time as an agonist, it, basically, means that you are undermining the therapeutic effect of the drug, and a lot of these are

aimed at trying to prevent the abuse situation. So, in other words,

some of these agonists are not orally absorbed, but can be effective

when given intravenously. So, if you put them into a pill, the theory would be, if that pill is crushed up and injected intravenously,

it would block that.

Mr. TIERNEY. Right.

Mr. MEYER. Unfortunately, this has just been a very hard scientific and chemistry challenge to get through, even though the

agonists—excuse me, the antagonists are not well absorbed orally,

they can change the property of the drug, even when given orally.

So, there are—it’s been a technical challenge that I think has been

very hard to get over.

Mr. TIERNEY. Well, should the government get involved in that?

Should we do some of our own research? Would that be good policy?

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Mr. MEYER. I think that would not be under the FDA, but I

think that—well, I guess, again, I would leave that sort of to the

policy people within FDA.

Mr. TIERNEY. Well, what about the—I mean, I know at one point

in time Purdue was investing some money in one of the companies

that was trying to do it, they withdrew their funds, would it be unreasonable to expect that the sponsor of a medicine like OxyContin

would be required to continue to keep investing?

Mr. MEYER. I don’t think that kind of requirement would be consistent with the authority under the FD&C Act as I understand it.

Mr. TIERNEY. As it currently exists.

So, they get to put it on the market, they get to know that there’s

a way to attack it, but they don’t have to have any obligation to

invest in pursuing that avenue, is the way the law is currently

written.

Mr. MEYER. If the drug is safe and effective for its proposed use

and shown to be in studies, then we approve it.

Mr. TIERNEY. OK.

Mr. Lynch brought up the point of advertising, or inappropriate

advertising for this drug. You’ve cited twice Purdue for that. What

about what’s told to physicians? You know, how do we assure ourselves that if you take off those inappropriate advertisements from

TV that representatives of these companies aren’t going in to physicians directly and telling them, you know, you can use off label,

because we don’t have any particular constraints, as I can see, on

physicians from prescribing off label. So, what if the company’s representative goes in and says, you know, this isn’t such a bad thing

for arthritis either, you can just go ahead and write it off label. We

don’t have to go up on TV, we are just going to send all of our millions out there and do it that way. Do we have any control over

that situation, is there any monitoring of it?

Mr. MEYER. Well, that certainly is considered part of the drug

advertising, and it needs to be consistent with the labeling. It is

a, I believe, an easier thing for the drug advertising people within

FDA to assess the print ads which are submitted by the companies

than it is to individually assess what’s being said to doctors.

That said, if reports come into DDMAD, which is the Division of

Drug Marketing and Advertising, about such cases, where a physician or someone else reports that a detail person is saying things

inconsistent with the labeling, that is followed up on.

Mr. TIERNEY. Wouldn’t it be good policy if we knew that we had

a problem with a drug like OxyContin, and we put the black box

on there and the labelings, we know that there are some limitations that we want, wouldn’t it be a good practice to just require

that it can only be prescribed for those things, and that particular

pharmaceutical agent couldn’t be prescribed off label for any other

use until it had gone through some sort of process at the FDA to

assure that it wasn’t going to create problems?

Mr. MEYER. I would be somewhat—I would be concerned about

that, as stating that would necessarily be good policy, because the

FDA generally has not wanted to constrict the practice of medicine.

We leave that much more to the State pharmacy boards and other

entities. In the case of the Controlled Substance Act, some of that

also falls within DEA.

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But, I believe that allowing physicians latitude to use appropriate judgment for prescription drugs, and here I’m talking broadly, it is a good thing.

Mr. TIERNEY. Well, I think broadly maybe it is, but we are talking here, you know, I’m familiar with one study being done now

that says 47 percent of new users of drugs are really from clinicians using off label to their drugs and then reporting what they’ve

done. So, there’s a bit of frequency where this is being done, the

off label prescribing.

When you know you have a situation like OxyContin, where it’s

being abused, and where it’s highly addictive, why would you in

that instance, not in all instances, but say, OK, this one we know,

so this one, perhaps, you can only prescribe it for the limited uses

on that and you can’t go off label with that, unless you come

through the FDA ahead of time and tell us what you are going to

do with it and we run through some tests on that basis. I mean

I wouldn’t say you necessarily do it generally, they can never prescribe off label, but when you know you have a problem, why not

try to contain that problem?

Mr. MEYER. Again, I would just have concerns about how that

might be a slippery slope. But, if you’d like a specific answer to

that from the policy standpoint, I’d be happy to get that.

Mr. TIERNEY. I would, indeed, if you would, please.

Mr. MEYER. OK.

Mr. TIERNEY. And, let me just ask one last question on this.

Well, let me clarify one issue with you, please. The hearing up here

is not as good as it may be down there, I don’t know if the others

are hearing, but there’s a fan going overhead, when you were talking about whether or not the FDA requires pharmaceutical companies to include risk management plans in new applications, did you

say that was or was not something that was done?

Mr. MEYER. For new opiates?

Mr. TIERNEY. New opiates, right.

Mr. MEYER. It is our expectation that they will be in place, and

it has been since that expectation has been set forth in guidances.

Mr. TIERNEY. OK. So, now it’s required.

Mr. MEYER. It is our expectation and it is what has happened.

Mr. TIERNEY. So, you are asking them to do this, but you are not

requiring it, is that the deal?

Mr. MEYER. Again, I believe I said earlier, I do not believe that

there is a specific authority in the FD&C Act to require a risk management plan, but it is our expectation that they will be in place.

Mr. TIERNEY. That’s what I wanted to clarify, because I want to

note with my colleagues that’s a direction that we may want to

look at, is why aren’t they required as opposed to just requested,

and one of your expectations. We’ve got a lot of expectations that

pharmaceutical companies haven’t quite borne out.

And, I’m going to leave it at that at this point in time, because

I have time constraints and have to get back to D.C.

But, I want to thank my colleagues, again, thank the witnesses,

and apologize to the coming witnesses that I won’t be here for their

testimony, but we will read it and hear from my colleagues what

you have to say.

Thank you.

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Ms. MILLER. Thank you, Representative. We appreciate that line

of questioning as well.

I might just ask the question of Doctor Meyer, you know, it is,

apparently, OxyContin was very revolutionary for pain, and as we

are all driving sort of a focus on much of this questioning of what

we can do to stop some of the abuse that is unfortunately happening, has the FDA ever had a similar type of a situation with a painkiller in the past, and what did you do in those circumstances, if

that’s so? In other words, perhaps we can look at best practices or

successes you have had in any other similar instances in curbing

the abuse.

Mr. MEYER. I’m really unaware of any kind of similar instance

where a single entity has become so prevalent and so notorious.

Actually, much less potent drugs are also commonly abused, including things like codeine, but it hasn’t had that sort of focus on

one specific entity that has really become so widespread.

So, I don’t think there is prior learning on this. There is certainly

learning going on now, and I can assure you that when the drug

was approved in 1995, as I said in my oral, we were not aware that

it would have the kind of potential for widespread abuse and misuse, such as its shown, and I think that we certainly learned some

important lessons about risk minimization, about education, about

tracking and so on, that will certainly be applied and are being applied in the future.

Ms. MILLER. Mr. Rannazzisi, I had asked a question previously

of Doctor Meyer about what Congress may be able to do to assist

the FDA, let me ask you a similar question. What could Congress

do to assist the DEA, as you are struggling, as well as preventing

some of the abuse and diversion of these prescription painkillers?

Do you have any specific ideas or conceptual ideas that we might

explore?

Mr. RANNAZZISI. That would be an issue for our policymakers. I

just want to thank you for doing this hearing, though, I mean,

that’s important, adjusting the focus to this type of drug abuse,

prescription drug abuse, something that’s been in the shadows for

so long, it’s good that a committee is taking this and putting it out

in the public forum. I think that’s important to us, and I think it’s

important for our parents to understand what their children are

doing. Abuse is widespread.

But, if you are asking me a specific recommendation that’s a policy matter, and we could get back to you on that from the Department.

Ms. MILLER. All right, we will be submitting that question to

your policy department as well.

And, at this time, I recognize Representative Lynch for a second

round of questions.

Mr. LYNCH. Thank you, Madam Chair.

Actually, you asked the question of the DEA representative that

I was going to ask.

I wish you had come prepared to answer that question, because

a lot of blame is being laid at the feet of the DEA for not interdicting, not intervening here, and allowing this problem to go forward.

And, when a committee of Congress asks you, what do you need

for us to help you do your jobs, I think it’s remiss to come here and

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say, well, that’s a policy issue. It goes to the very heart of your mission. I have your mission statements right here, both the FDA and

for DEA, and I’ve got to tell you, I’m disappointed. I’m disappointed

that you come here, we ask you what you need, you know, this is

a problem with bureaucracy, I’ve got to tell you, you should have

come here prepared to say, we need X, Y, Z, this is what we need,

and, you know, to do our job we need to have your help. And, you

know, that’s what I would have if I was sitting in your chair, I

would have came with a laundry list. I would have told the Members of Congress exactly what I needed to get my job done, and not

we’ll get back to you. You know.

So, I guess that’s all I have.

Thank you.

Ms. MILLER. Thank you.

Well, we want to thank both the witnesses again for coming to

the hearing. You’ve been somewhat enlightening, not entirely, and

we appreciate your testimony, though, very much, and we’ll look

forward to hearing from the next panel.

At this time we’ll take a brief recess.

[Recess.]

Ms. MILLER. We’ll call the Subcommittee on Regulatory Affairs

back to order, and for our second panel, because Government Reform is an oversight committee we do have subpoena authority, it

is our practice, whether we are in Washington, DC, or in the field

here, and anywhere else in the Nation, that we swear in our panel.

So, if you could please rise and raise your right hands.

[Witnesses sworn.]

Ms. MILLER. Thank you very much.

We will now hear from State Senator Steven Tolman. In 1998,

Senator Tolman was elected to the Massachusetts State Senate,

after having served 2 years as—two terms actually, as a State representative. He chairs the Mental Health and Substance Abuse

Committee. He is also extremely active in his community, serving

on the Board of Directors for the Allston/Brighton YMCA.

Senator Tolman, we certainly appreciate your attendance at our

hearing here today, we look forward to your testimony, sir.

STATEMENTS OF STEVEN A. TOLMAN, MASSACHUSETTS STATE

SENATOR; BRIAN WALLACE, MASSACHUSETTS STATE REPRESENTATIVE; JOHN McGAHAN, EXECUTIVE DIRECTOR,

CUSHING HOUSE; AND JANET L. ABRAHM, CO-DIRECTOR,

PAIN AND PALLIATIVE CARE PROGRAMS, DANA FARBER

CANCER INSTITUTE AND BRIGHAM AND WOMEN’S HOSPITAL, AND ASSOCIATE PROFESSOR OF MEDICINE AND ANESTHESIA, HARVARD MEDICAL SCHOOL

STATEMENT OF STEVEN TOLMAN

Mr. TOLMAN. Well, thank you, Madam Chair, and Congressman

Lynch, and I was going to say the other Members, but I can tell

you that there is nothing more important that we face in Massachusetts and I applaud your efforts for being here today, knowing

how busy you are.

I’m the State Senator from the 2nd Suffolk and Middlesex District. My district includes Allston, Brighton, Watertown, Belmont,

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Cambridge, and a very big part of Boston. I’m currently, as you

said, the Senate Chair of Mental Health and Substance Abuse,

which is a new committee this year, and the new committee in

many ways comes out of the silent epidemic that I hope to speak

about.

I’d like to commend you for holding the hearing, and I’d like to

begin by providing some statistics that illustrate the problems

we’re facing in Massachusetts.

OxyContin abuse is a crisis of epidemic proportions. In 2002,

Boston had the highest emergency department rate of oxycodone,

the primary ingredient of OxyContin, in the Nation. In fact, Boston’s emergency department rate of 34 per 100,000 people was

nearly four times higher than the national average of 9 per

100,000, and it has increased 118 percent since 2000. The number

of people who have entered treatment in Boston and reported other

opiates, which would include oxycodone, as their primary drug increased, Madam Chair, nearly 250 percent from 2000 to 2004.

OxyContin addiction knows no age, no gender, no ethnic or social

economic bounds; it is everywhere. It is breaking parents’ hearts.

It is ruining good families. It is destroying our communities, and

it is killing people, and we have been hit very hard here in Massachusetts. We have seen an increasing number of pharmacy burglaries and armed robberies that have been attributed to the rise

of OxyContin abuse. During 2002, there were 166 pharmacy thefts

reported in New England, as Congressman Lynch had reported.

Madam Chair, 144 of those took place right here in Massachusetts,

and some of the people who did it were from good families, not of

their character, but suffered a very serious addiction.

In 2002–2003, we ranked third among the 50 States for illicit

drug dependence or abuse and had the highest rate in New England among ages of 26 and older. In 2003, there were 11,257

opioid-related emergency department visits and 17,600 opioid-related acute care hospital discharges among Massachusetts residents.

In fact, in 2003 we spent over $167 million on opioid-related hospitalizations across the State.

Currently today, Madam Chair, poisonings, which include drug

overdoses, are the leading cause of injury death in this State, surpassing for the first time even motor vehicle accidents. They have

gone up 128 percent from 1990 to 2003.

Here in Massachusetts, one of the most important things we can

do is educate the people on the dangers of OxyContin abuse. Locally, the Boston Public Health Commission has begun airing hardhitting public service announcements aimed at children between

the ages of 12 and 24. To date, they’ve run 109 radio commercials

and have reached an estimated 300,000 people in the target audience. The message has been uniform, OxyContin abuse is on the

rise. It is extremely addictive. It leads to heroin, and it will kill

you.

Across Massachusetts, the State’s Bureau of Substance Abuse

Services is also developing a public information campaign in order

to educate families on the dangers of OxyContin. This campaign is

expected to be rolled out, hopefully, this fall, and it’s expected that

we will spend minimum of a half a million dollars. It’s a start,

Madam Chair, but we must do more.

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Funding to help those who are addicted is also crucial to dealing

with this epidemic. However, Massachusetts has suffered from

drastic cuts, as you’ve heard, on the detox beds. We are down from

1991, there were approximately 950 detox, publicly funded detox

beds, in the Commonwealth of Massachusetts, we are at about 450

to 500 beds currently, largely the result of the cuts to Medicaid

programs that number has dropped to the 450, and that’s a cut of

nearly 50 percent during this critical period. With the new supplemental funding through the Federal Government and the State,

and funding appropriated to the Bureau of Substance Abuse, some

of the beds will be restored, but this deficiency remains a very serious problem.

We must also develop more significant after care and job training

programs to accompany our detox. They refer to it as ‘‘spin cycle,’’

when you go through the detox you start to feel normal and you

don’t think you need an additional program. And, in this battle on

OxyContin and heroin, Madam Chair, we need to have substantial

programs where the people, when they do the detox, they stay and

really get the help so that they stay off this drug.

In Massachusetts, we have filed several bills designed to raise

the debate on the OxyContin addiction and to address the problems

that we are currently facing. Several months ago we filed a bill to

ban Palladone, Representative Wallace and I, and thank God,

thank God the FDA has taken it off the market, or ordered them

to take it off the market. We could only imagine if we doubled the

magnification of this problem that we are currently facing with a

drug twice as powerful.

We’ve also filed a bill, and I’m proud to say that I filed a bill to

ban OxyContin with the good representative sitting next to me. In

Massachusetts, by changing the designation within the Controlled

Substance Act, this bill has proven controversial, but it has caught

people’s awareness, and most importantly it’s becoming more prevalent that we have a very serious epidemic on our hands. We are

going to continue to fight to get this bill out of the House Rules

Committee, to make sure it gets a public hearing, and air it before

the entire legislature.

Under the current system, this information is often reported. As

I mentioned, in 2003, there were significant opioid-related department visits, over 11,000 among Massachusetts residents, but under

the current system this information is often reported 12 to 18

months after the emergency room visits occur. In order to maximize the benefit of this information, we have filed a bill that would

require that all hospitals report an opiate overdose to the Department of Public Health within 24 hours, and then we’ll be able to

geographically identify the problem far more effectively.

It’s important to note that this is not a law enforcement tool. Information is not reported to the police, no names, or addresses, or

Social Security numbers are reported. Rather, it’s designed to gather the demographic characteristics in order to identify the problem

within our community, so we can quickly respond and effectively

treat those areas most needing help.

Finally, last year the legislature created a commission on

OxyContin. To date, the Commission has held several meetings

around the State. The next one will take place on September 22nd

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in Somerville. I’m hopeful the final report will include innovative,

aggressive proposals to deal with the problems of OxyContin and

all it has created.

In closing, I cannot tell you how many families have expressed

to me the heartache as they try to deal with loved ones who have

an OxyContin or heroin addiction problem. During a recent visit to

a treatment center, of a young man who I saw grow up and get into

serious addiction, while he was in recovery in a group session he

said to me, ‘‘Steven, the hardest part for me was telling my mom

and dad I had an addiction.’’ Madam Chair, I thought he was done,

but then he said, ‘‘The scariest part is how many of my friends

have an addiction and aren’t talking to their parents.’’ And, that’s

the problem. We have people in Massachusetts who are taking this

drug to exist, not because they are getting high, because if they

don’t take it they’ll get sick, and they can work, and they can hide

this drug, this dreaded disease, they can hide it, and that’s how

bad this what we refer to as a ‘‘silent epidemic.’’ Madam Chair,

there’s not enough we can do. If I could ban this drug, I would do

it today.

OxyContin is not a gateway to heroin. Madam Chair, it’s a rocket

ship to heroin, and that’s what we are seeing throughout our communities. We must attack the problem before it destroys us from

within.

Thank you.

[The prepared statement of Mr. Tolman follows:]

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Ms. MILLER. Thank you very much, Senator.

Now the subcommittee will hear testimony from State Representative Brian Wallace. Representative Wallace took office in 2003. He

currently serves on the House Committee on Steering, Policy and

Scheduling, also on the Joint Committee of Mental Health and

Substance Abuse, as well as the Joint Committee on Tourism, Arts

and Cultural Development.

We certainly want to thank you, Representative, for attending

our hearing today, and look forward to your testimony, sir.

STATEMENT OF BRIAN WALLACE

Mr. WALLACE. Thank you, and welcome to Boston, Madam Chairman.

I represent the 4th Suffolk District, a seat that was held by some

legends, Joe Moakley and Congressman Lynch before me, so I just

want to say that I’m honored to be here, and I’m honored to sit in

that historic seat.

In 1860, the man who was appointed by President Lincoln to

head up the Patent Office in Washington said that there really

wouldn’t be much need for a Patent Office much longer because everything that could be invented had already been invented, a real

visionary I must say.

I’m beginning my testimony today with this little vignette to

highlight the fact that people make mistakes, even people in government make mistakes, as strange as that seems. Have there

been mistakes made with OxyContin? Absolutely. Will we learn

from those mistakes? God, I hope so. Mistakes are going to happen.

It’s what we do to rectify those mistakes that’s important.

I don’t think anyone in this room would argue with the fact that

the FDA made a mistake in 1898 when they legalized a drug called

heroin, which they said was safer than morphine. For a time, some

doctors were even championing heroin as a cure for morphine addiction.

In the year 1900, 2 years after heroin was legalized, there were

an estimated 300,000 morphine addicts in the United States, including many Civil War veterans who had become addicted while

being treated for war-related injuries. The condition was so commonplace it was called, ‘‘The Soldiers Disease.’’

In 1924, some 26 years after it was legalized, the government

stepped in and banned the sale of heroin. At that time, in 1924,

it was estimated that from 4 to 24 percent of patients who were

being treated in drug addiction programs had first been exposed to

the medication while being treated by a physician for pain. Does

that sound familiar?

Those who do not learn from history are due to repeat it. I don’t

think Purdue learned anything from history, or they simply chose

to ignore it.

I wish the officials at Purdue had spent more time reading about

the history of pain medication in this country, rather than reading

about their profit margins. And, make no mistake about it, this is

all about the bottom line in profit margins.

Families have been ruined, communities in shambles, people

dead, people dying a slow death of addiction, people stealing from

their neighbors, pharmacies under constant threat, as Purdue

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Pharma continues to climb to the magic $2 billion mark with its

prized possession, OxyContin.

I think what upsets me the most is the fact that officials at Purdue knew that their drug, OxyContin, had been compromised as

early as 1998, and instead or reformulating the drug they chose to

flood the country with it.

In 1998, a detailed report on time-release narcotics appeared in

a very prestigious medical journal that foretold what lay ahead.

The study’s bottom line was that release painkillers were potentially more addictive to drug users, not less so, because their narcotic payload was stronger and purer. This was the first time the

research appeared to contradict safety concern claims made for the

time-release narcotics such as those used by the FDA when it approved OxyContin special label.

In early 1999, a California doctor named Frank Fisher, as well

as the owners of a local drugstore, were arrested and charged with

murder in connection with the deaths of three of Fisher’s patients

from drug overdoses that involved OxyContin. Purdue was more

than aware of the trial and the ensuing bad publicity that followed.

In the same 1999, Doctor Richard Norton, a doctor from Pennington Gap, VA, told Purdue in detail how people were getting

high and overdosing by crushing and chewing OxyContin tablets.

That same year 1999, a drugstore owner in Indiana named John

Craig was told by a Purdue sales rep that OxyContin couldn’t be

crushed and couldn’t be injected.

One former Purdue district sales manager, William Gergely, told

the Florida Attorney General that top company marketing and

sales executives at Purdue Pharma were telling their sales reps to

tell doctors that OxyContin was non-habit forming. In all, Purdue

sales reps were told in their training to tell doctors that less than

1 percent, less than 1 percent of their patients, were in danger of

becoming addicted to OxyContin, even as the death toll mounted

across the country. Purdue Pharma was well aware of the dangers

that its drug OxyContin was causing throughout the country well

before the millennium. The signs were there, and people were

screaming for help, and there was no shortage of Purdue salesmen

or saleswomen.

By 1998, Purdue sales force was standing at 625 people, nearly

twice the level prior to the introduction of OxyContin, and because

of its sales base bonus system, which were considered to be the

most lucrative in the pharmaceutical industry, many sales reps

were earning annual bonuses of well over $100,000.

By 2002, Purdue was selling nearly $30 million of OxyContin per

week, $30 million per week. And, with the data collected from the

Philadelphia-based IMS Health report in hand, Purdue sales reps

not only knew how much OxyContin a doctor was prescribing, but

they also knew how many prescriptions doctors were writing for

competing painkillers, allowing them to tailor their sales pitch.

Doctors were ranked by Purdue according to their prescribing

volume as decibels, with a 10 being the highest. Doctors who were

classified as decibels 8 through 10 were considered prime targets

for OxyContin sales reps. The more doctors bought in, the more

money the sales rep received, and the more people died.

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I recently filed a bill, along with Senator Tolman, in the Massachusetts House of Representatives to restrict Palladone from getting a foothold in our State. A few months ago, the FDA and Purdue Pharma pulled Palladone, which is a 24-hour time release morphine-based medication. What did Purdue Pharma do when

Palladone was pulled? They immediately said they would reformulate Palladone and have it back on the shelves in a short time. It

has always been my contention that Purdue Pharma could have reformulated OxyContin, if it had been pulled by the FDA, which it

wasn’t.

Now, they are facing over 6,500 individual lawsuits from soccer

moms, teachers, firefighters, police officers, radio talk show hosts,

and other average people, who went to their doctor to get help for

a sore shoulder or a sprained ankle and wound up addicted to

OxyContin. Many have lost their jobs, businesses and families, but

the good news is that Purdue broke the $2 million mark. Congratulations, Purdue.

Thank you.

[The prepared statement of Mr. Wallace follows:]

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Ms. MILLER. Thank you very much, Representative. We appreciate that.

Our next witness will be John McGahan. Mr. McGahan is the executive director at the Cushing House in south Boston. The Cushing House is a rehabilitation center for teens with substance abuse

problems. He graduated from south Boston Neighborhood Health in

1994, and as the current director he volunteers many hours coaching our youth as well.

We thank you for your participation today, and look forward to

hearing your remarks, sir.

STATEMENT OF JOHN McGAHAN

Mr. MCGAHAN. Chairwoman Miller, and Congressman Lynch, on

behalf of those whose lives have been impacted by the illegal use

and abuse of prescription painkillers, I want to thank you for taking your significant commitment and hard work on this issue, and

for the opportunity to testify here today.

My name is John McGahan, and I am the executive director of

the Gavin Foundation. The Foundation operates several residential

drug rehabilitation programs in the south Boston community. In

1964, the Gavin House opened its doors and over the next three

decades the concentration was placed upon treating alcoholic men,

40 to 50 years of age. Since then, the entire landscape of substance

abuse treatment has changed.

In the late 1980’s and early 1990’s, treatment became more complex, because cocaine was the rage and attracted younger clientele.

Treatment approaches were altered to allow for this deviation. Just

as we thought it couldn’t get any worse, OxyContin hit the streets.

Our response has been to expand services to accommodate an

even younger clientele, and the overall increased demand for treatment. The Foundation responded to this need in 1996, by creating

the Total Immersion Program in partnership with South Boston

District Court. This program focuses on individuals whose criminal

activity is clearly substance abuse related.

As the flow of prescription painkillers continues to infiltrate the

streets of south Boston, the Foundation has expanded services to

include Cushing House, a 12-bed adolescent recovery home for

boys, in 1999. This program was expanded to 16 in 2004, and we

are currently building an addition to accommodate 12 adolescent

females.

Unfortunately, even with our current growth pattern, we are unable to provide services to many families that are being devastated

as a result of prescription painkiller abuse.

Experiences with treatment abusers of prescription painkillers,

particularly, the drug OxyContin, has shown this opiate-based pain

reliever is a predominate precursor to heroin use. In fact, every single opiate addicted participant of our program began to abuse

OxyContin before they became addicted to heroin.

The legal price of OxyContin is significantly marked-up when

sold on the streets. At the current rate of $1 per milligram an OC,

the street name for OxyContin is sold as an OC 40 for $40 or OC

80 for $80. Clients report having habits that cost as much as $200

a day.

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Some OxyContin users so glorify the effects of the drug that

younger siblings and their friends are often coaxed into its use or

recruited as a way to get money for their own use. This permeation

results in an unbridled spread of its use. As users become addicted,

the dose needed to get high, or simply not get sick, continues to increase.

Addiction is inevitable with regular use. OxyContin becomes a

critical need, just to feel normal. Stealing to afford the continuous

use of the drug is commonplace; family, friends, neighbors, businesses, are all victimized. No one is immune to these larcenous attacks.

Inevitably, the exorbitant cost of OxyContin and the absolute

need for relief of a withdrawal pain leads an OxyContin user to the

cheaper and very effective remedy, heroin. Heroin is one tenth the

cost of OxyContin.

Heroin, now becomes the drug of choice. The stigma attached to

its use has blurred for the user, particularly when viewed as an alternative to the high priced prescription pain relievers. Many heroin addicts recall saying that they would never use heroin, but the

day came when they didn’t have enough money for OxyContin and

switched to heroin. When this happens, often the stigma attached

to the heroin by the non-user results in even family members abandoning the addict and leaving them to live on the streets.

Overdoses, once feared as the ultimate test for an addict’s commitment to drug use, are now commonplace. Emergency responses

to overdose has risen dramatically in recent years in south Boston

according to the Boston Public Health Commission statistics.

The ancillary medical consequences are severe. OxyContin and

other pain relievers are commonly purchased in pill form and

crushed. It is then snorted or liquified and injected intravenously.

These methods of use increase the chances of the contraction of

HIV/AIDS and, increasingly, Hepatitis-C. The incidence of Hepatitis-C has exploded in south Boston, affecting clients in all of our

programs.

A little history of a family here. At Cushing House we received

a referral in May 2000 from a South Boston Probation Department

for an 18 year old male who was illegally using OxyContin and

Klonipin, that was being charged with civil disobedience. We interviewed Mike that day and sent him to a medical detoxification

unit. Once Mike had medical clearance, he was placed in a Transitional Support Service program, while waiting for a treatment bed.

Mike entered our program on June 12th. Mike was fully participating in the treatment process and had reached the second phase

of treatment. Residents in this phase of treatment are reintegrated

into the community, either through an education or vocational program or employment. Mike was working during the day and participating in group therapy, individual counseling, and self-help

groups in the evening. On August 23rd, Mike was discharged from

the program, referred back to the criminal justice system. There

was no specific test for OxyContin at that time. His discharge was

recorded in the general class of opiate.

The probation department placed Mike in an Intense Outpatient

Program pending his trial. He also participated in our program’s

alumni relapse prevention group. It was at this group he reported

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that he was again abusing opiates daily and needed a referral to

detox.

The case manager, with Mike’s permission, communicated with

the probation department the situation, and he was again placed

in a detoxification unit and subsequently reentered our program on

September 11th.

Mike completed the program on March 3, 2001. While in treatment he achieved his General Equivalency Diploma and completed

a Culinary Arts Certificate program. The criminal charges were

dropped upon completion of the program and Mike has been an active participant in our alumni group ever since.

Mike has achieved many successes as a result of maintaining sobriety. This success is shared by his parents, who were extremely

supportive throughout the treatment process. During the certificate

ceremony to celebrate Mike’s graduation from the residential component of the program, his 14 year old brother had asked to speak

to me in private. I brought him into my office where he began to

cry and asked, ‘‘Can you do for me what you did for my brother?’’

I suggested that we let everyone enjoy the day and that I would

speak to his parents the next day. When the family was leaving,

Mike’s mom said to me, ‘‘Don’t take this the wrong way, but I hope

we don’t see you for a while.’’

The next day I called Mike’s father and asked him to come and

speak with me. He came right in. I had to deliver the bad news

that his youngest son Steve was using prescription painkillers,

OxyContin. Because Steve was only 14, and not yet a daily user,

I referred them to outpatient counseling.

Steve continued to use and now his addiction was interfering

with family functions and school work. It is worth noting that

Steve was enrolled in the test school, Latin Academy, one of Boston’s most prestigious public schools. Steve missed so many days of

school due to his addiction he did not pass the 7th grade.

It became obvious that Steve was in need of more intensive treatment and was referred to a detoxification unit and entered our program on June 12, 2001. Steve participated in all aspects of the program and good progress was noted. He successfully completed the

program December 7th of that year. While in treatment, Steve was

enrolled in a special education program that allowed him to condense the 7th and 8th grades together so that he could rejoin his

classmates in the 9th grade. He successfully completed the program and was prepared to rejoin his classmates in the fall.

Unfortunately, Steve began to abuse painkillers before the summer was over. His relapse to prescription painkillers, and specifically OxyContin, quickly turned to heroin use, because he could not

afford his $80 a day habit. Steve reported that he felt like he didn’t

fit anywhere, he couldn’t relate to people his own age, felt that he

was too young to get sober. He stated that he just wanted to be

a kid, but that he had been robbed of his youth.

Steve went to detox and reentered our program on August 8,

2002. He left the program against the treatment team’s advice on

October 2002, because he didn’t think he needed help and he could

do it on his own.

I want to remind you that he has a brother at home who is trying to maintain sobriety. He also has an older sister attending high

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school, and two loving parents who both work and are doing their

best to hold the family together. We can only imagine the day-today tension and stress this family had to endure, which all began

with the abuse of prescription painkillers.

Steve relapsed almost immediately upon leaving the program.

Our case manager continued to work with his parents through the

family support group and a referral was made to a short-term

treatment facility in the western part of the State.

After completing the short-term program, Steve returned to

Cushing House for 191 days. He graduated on July 7, 2003, and

now has over 2 years of continuous sobriety. He is a productive

member of society and an active member of our alumni group.

This is the story of one of the lucky families, that is if you call

having family members in and out of treatment for 3 plus years,

being involved in the courts, having your children settle for GEDs,

and countless nights wondering where your children are, and if

they are alive—lucky.

As a treatment provider and a resident of the south Boston community, I can tell you countless stories of families who have not

been so lucky and who have lost loved ones to the streets, jails and

overdoses.

Thank you.

[The prepared statement of Mr. McGahan follows:]

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Ms. MILLER. Thank you.

Our next witness is Doctor Janet Abrahm. She is a hematologist

and oncologist and a palliative care specialist. She is an associate

professor of medicine and anesthesia at Harvard Medical School.

She is also the co-director of the Pain and Palliative Care Programs

at the Dana Farber Cancer Institute, and Brigham and Women’s

Hospital. She is responsible for developing a disease management

program for end-of-life care, a computerized opioid conversion program for in-patient pain management as well.

We appreciate your attendance today, Doctor, and look forward

to your testimony.

STATEMENT OF JANET L. ABRAHM

Dr. ABRAHM. Thank you, Chairwoman Miller, Congressman

Lynch, and members of the committee.

On behalf of the American Cancer Society, I would like to thank

you for this opportunity to testify before the subcommittee today.

My name is Doctor Janet Abrahm, and I am the co-director of the

Pain and Palliative Care Program at Dana Farber Institute, and

Brigham and Women’s Hospitals here in Boston.

Twenty-five years ago, when I began to practice, all I could offer

someone with pain from widely metastatic cancer was morphine or

oxycodone that they had to take every 4 hours. It made them

drowsy, and only gave them good pain relief for maybe 2 of those

4 hours.

The availability of morphine and oxycodone in sustained-release

preparations has profoundly changed the lives of today’s cancer patients, and of their families. Now that they have continuous pain

relief, they can even forget for a while that they have cancer.

As the testimonies today have indicated, prescription drug abuse

is a serious problem facing our State and our Nation. However, as

we assess legislative and regulatory solutions to this problem, we

must ensure that we shape policies that will curb abuse without

interfering with quality patient care, and worsening under treatment of pain that is unnecessarily destroying the quality of life for

nearly half of the patients with advanced cancer today.

Misperceptions and misinformation about the risk of addiction to

certain pain medications can lead patients themselves and physicians to avoid the most effective means of pain control. Addiction

is a psychological dependence that is associated with compulsive

drug abuse and continued use despite harm.

Cancer patients who take their opioids for pain are not addicts.

They use their drugs to get back into their lives. Addicts are using

the drugs to get out of their lives.

Because drugs like ibuprofen and acetaminophen do not relieve

the pain of the majority of cancer patients, we must use Schedule

II prescription pain medications, both in immediate and sustainedrelease forms. Cancer patients lucky enough to respond to treatment stop taking the opioids. Those with advanced cancer, who use

sustained-release opioids like OxyContin use them only to relieve

their pain, to get back into their families, to get back into their

workplaces, to be able to go to church.

We have heard extremely compelling stories today about the

abuse that is plaguing south Boston and other communities

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throughout our Nation. However, we cannot let our sympathy for

these children and for their families prevent us for speaking up for

the families who have loved ones suffering from cancer and from

other chronic pain.

I have already seen the suffering that comes from physician fears

leading to inadequate opioid prescribing and from the stigma of

taking opioid medication. I once cared for Mr. R, an African American veteran in his mid 50’s, suffering from metastatic prostate

cancer. He arrived on a stretcher, accompanied by his wife and his

sister. Mr. R’s cancer had spread to all the bones of his body, and

it was no longer responding to treatment. He had been told to take

600 milligrams of ibuprofen, which is a pain reliever in medications

like Motrin, four times a day. His pain was so severe that with his

crying wife and sister listening he asked me to help him die.

Mr. R needed more than ibuprofen for his metastatic cancer pain.

He needed opioids. African Americans like Mr. R and other minority patients, and children, and the elderly, are unfortunately more

likely than Whites to have their pain under treated.

We started him on both a short-acting and a long-acting form of

morphine, but even though his pain improved he developed severe

nightmares and persistent nausea, and he couldn’t eat.

After we switched him to OxyContin the nightmares and nausea

resolved. He lived almost pain free for over 2 years after that first

day when he asked me to end his life. He was able to sleep, return

to church in his case, and even to go on trips with his wife. Control

of his pain gave them all back his life.

Mr. L was another veteran I cared for. He had developed multiple myeloma, which is a cancer that weakened his bones and

caused him severe pain in his back, and hips and legs. He could

not tolerate ibuprofen or aspirin, or any of its relatives that cause

bleeding, and the acetaminophen that he took on his own wasn’t

effective. We couldn’t use sustained-release morphine because the

morphine had made him delirious, so we chose OxyContin with

supplemental oxycodone as needed.

However, when his wife went to the pharmacy to have the

OxyContin prescription filled, the other customers treated her like

she was a drug addict. She was so ashamed she almost left without

filling the prescription, and recounted this story to me in tears.

My patients did not choose to wake up 1 day to hear the words,

‘‘You have cancer.’’ On the contrary, people who use OxyContin,

who abuse OxyContin, do have a choice. Doctors, nurses, and pharmacists must continue to be held responsible for improper prescribing. However, legislative and regulatory efforts must be focused on

the primary sources of the problem, such as pharmacy theft, forgery and diversion operation. Abuse and diversion of the prescription drugs should be addressed directly, without interfering with

patient access to essential treatments and without debilitating legitimate medical practices.

The American Cancer Society supports efforts to prevent the

abuse and misuse of opioids and stands ready to work with Federal, State and local officials to find avenues to address escalating

abuse problems, without contributing to the already gross under

treatment of cancer pain and other serious chronic pain.

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Toward that end, the American Cancer Society has submitted

written testimony for the record.

For my patients, and thousands of others who suffer from persistent pain, OxyContin and other prescription opioid medications

are often the only effective and efficient treatment options. When

used for legitimate medical purposes, these medications can dramatically improve the quality of life for cancer patients and millions of other Americans who would be forced to live their lives in

unbearable chronic pain.

Thank you again for the opportunity to give cancer patients a

voice here. I would be happy to answer any questions.

[The prepared statement of Dr. Abrahm follows:]

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Ms. MILLER. Thank you all very much. It’s been very enlightening for me. I have to tell you, coming from Michigan, and I don’t

care where you come from in the Nation, obviously, drug abuse is

everywhere, but I am stunned to be here in Boston, and I thank

Representative Lynch again for asking that we come here for this

field hearing; I’m stunned to hear the statistics of how bad this

particular abuse problem is here in Massachusetts and in Boston.

I think, Senator, you were saying it was four times the national average at one point, and this may sound like a very simplistic question, but why? Why is it so bad here, so much worse than anywhere

else in the Nation? Do you have any—could you enlighten me on

any of your own personal observations of why that may be the case

here?

Mr. TOLMAN. Whether it’s the way it’s prescribed too liberally

and made it more available for youngsters, or even, you know, construction workers with injuries, I have one example of somebody

that—a law firm that allegedly has 58,000 clients who were legitimately prescribed this drug who are now suing the company because of its level of addiction.

In many cases, maybe whether it’s all the universities in Massachusetts, sometimes as we grow up and you experiment in life you

like to live on the edge, and that you try something like we all did

growing up, whether it was a can of beer in the woods or whatever.

Unfortunately, the legitimacy of a prescription drug takes a lot of

the scare away, where somebody wouldn’t go out and try heroin,

but if they think there’s a legitimate painkiller that might get them

high, or do something, whatever, but, unfortunately, what we see

is after using this the level of addiction is so bad on the brain, my

understanding is it just dries up the endorphins in your brain, but

magnifies the receivers, and so that many people just experiment

and may try this.

It’s very bad in New Bedford, it’s not just Boston, it’s through

this entire State. We have the No. 1 for professional baseball a couple of years ago out of Peabody addicted. It’s not just in Boston, it’s

in Lawrence, it’s in Lowell, it’s in Springfield, it’s geographically all

over the State. And, the scary part about it is, we don’t have the

specific answer, Madam Chair, to your question as to why, whether

it’s the harbors, because New Bedford is riddled with it, and Fall

River, or maybe here.

But, most importantly, the piece is, is that you don’t have the

stigma of how dangerous this drug is, and that’s what we have to

get the message out.

The good doctor talked about those patients, patient R and patient L, and I can relate to that, I lost a sister to breast cancer last

summer, and I know that drug may have relieved her of some pain,

and I respect and understand that concept. And, I loved my sisterin-law, but I also weigh the damage, not just to one family, but to

communities, and it far magnifies, outweighs, you know, the legitimate prescription of this drug, because they’ve gone beyond patient

R and patient L, and now, Madam Chair, we have this in generic

forms being made in Israel and imported, I think there’s two firms

out of Pennsylvania. So, we are having more of it on the street.

And, unless we aggressively say, hey, for the good doctor’s needs

maybe, there may be a need for this drug, but it is far, far too often

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prescribed, and certainly the significance of the addiction is beyond

anything I have ever seen in my life. And, I was a union rep in

the labor movement, and I saw crack in the minority neighborhoods, and that was the most devastating thing that I have seen

in the 1980’s. This magnifies it by 10.

Ms. MILLER. Representative I might ask you, along the same

lines, what are your personal observations of why this is actually

happening here? You spoke in your testimony about the pharmaceutical industry, perhaps, with their marketing toward particular

doctors, do you think they find particularly fertile ground here for

that kind of a thing? Is that part of it? And, I do recognize both

you gentlemen have introduced legislation to actually ban

OxyContin. Do you think if that were to be successful that would—

it would obviously have an impact, but would they just then be

looking at one of these generics, or what can we look forward to?

Mr. WALLACE. To be quite honest with you, I don’t think

OxyContin is going to be banned, and for a number of reasons.

First of all, I would love to see OxyContin banned, Madam Chairman, if there was a tamper-proof OxyContin pill that was made,

and I think that is what the magic bullet is. There’s a pharmacy,

a lead pharmacy now, I think out of Philadelphia, who the FDA

has approved to clinically study the tamper-proof OxyContin tablet

they say they have. That’s the magic bullet that everyone is looking

for.

You know, in my district it’s, you know, we used to get calls for

jobs and for housing, and those calls have been replaced by calls

for detox centers and help, and these are families that have never

been in the court system, they don’t know—some of them don’t

even know where the juvenile court is, to be quite honest with you.

I’ve got to go myself with these people who have no idea where the

juvenile court was, but yet their son or daughter is in juvenile

court for stealing, for credit card fraud, for possession of OxyContin

or heroin.

Again, as Senator Tolman said, we had a hearing and I asked

one of the kids who was in Meridian House, which is in east Boston, I said, ‘‘Son,’’ I said, ‘‘Can you tell me, if you don’t want to tell

me you don’t have to, but where did you get OxyContin?’’

He said, ‘‘Representative, what I would do is, I would go to a

pharmacy and I would wait there until I saw someone get it prescribed. I would follow him home, break in the house and steal it.’’

And, this is what’s happening. This is what this drug has done

to our communities, all across the country.

Purdue Pharma, I think the problem, the way I see it, is that if

they had marketed this for cancer patients strictly, or for people

with real serious pain, I think that would have been fine, but once

they opened up Pandora’s Box, and that’s what it is, Madam Chairman, they opened up Pandora’s Box, and they prescribed it for dentists, for people with sore shoulders, for sprained ankles, once they

did that it became—it flooded the country, not only in Massachusetts, Virginia, Maine is probably the worst, Virginia is probably

next, and these people started seeing this, as I mentioned it, in

1998, 3 years after the drug was introduced, and nothing was done

about it.

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So, I mean, it’s a question now that Pandora’s Box has been

opened, now we have to deal with the generics, which are going to

create all kinds of problems, because we don’t know where they are

coming from. At least Purdue Pharma, we had some sort of idea

where they were coming from.

A doctor was arrested in Sandwich, and Sandwich is part of Cape

Cod, recently. He prescribed one out of every three OxyContin tablets in the State, but yet he was allowed to do that for 6 to 7 years.

There has to be some sort of enforcement. Someone has to know

that this doctor is doing that.

Purdue said they have the mechanism to follow that, if they followed it why don’t they tell the DEA? There’s a doctor in Sandwich

that’s prescribing one out of every three OxyContin tablets in Massachusetts. That didn’t happen, and that has to happen. The DEA,

the FDA, they have to work in conjunction so that Purdue knows

who is selling it, they have to tell the DEA, or otherwise what good

is it? What good are all these mechanisms they have for following

where their drugs go if they are not telling anyone? And, that’s one

of the problems I see, and again, thank you for—we appreciate you

being here very much today.

Ms. MILLER. Yes, I appreciate that answer.

So, let me ask Doctor Abrahm, from a doctor’s perspective, and

I know you were in the audience, you heard the testimony from the

FDA and the DEA witnesses that we had here who declined to answer both myself and Representative Lynch’s question about what

kind of things—tools the Congress could give them to assist in the

scourges. Could you give me your observations from a doctor’s perspective on what kinds of things the government could do to stop

the abuse of this very powerful drug, as you stated so eloquently

and articulated, in giving us some particulars there about a patient

that you used to prescribe it to, and how important it is for pain

management, but yet we see these problems. Could you give us any

direction from your own observation in your own clinical practice?

Dr. ABRAHM. Well, it’s hard to do it from my own clinical practice, since I prescribe the drug for people who need it for cancer

pain and for sickle cell, severe sickle cell pain even, though I don’t

take care of sickle cell patients anymore.

I would say that from the American Cancer Society’s perspective,

and from the pain community’s perspective, the importance of getting the FDA, and the DEA, and the pharmacists, and the doctors

and nurses together, to be able to figure out, along with the pharmaceutical companies, ways to regulate the production of the medication. And again, we totally agree that in an abuse-free form that

is how we would like this drug to appear.

And, if there are ways to be able to also get at the other causes,

of course, of drug addiction, which are much bigger than a question

that I could answer here, but the kind of suffering that an addict

has, the kind of suffering that the people who aren’t just experimenting once or twice, but really have suffering and are using

these drugs to treat their suffering, the more support there is for

that kind of work that you guys are doing, the more kind of understanding that there are societal causes of suffering, and the more

attention there is to supporting those needs, I think for all the addictions we have, methamphetamine addictions, OxyContin addicVerDate 11-MAY-2000 10:37 Jul 12, 2006 Jkt 000000 PO 00000 Frm 00097 Fmt 6633 Sfmt 6633 D:\DOCS\24947.TXT HGOVREF1 PsN: HGOVREF1
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tions, alcohol addictions, heroin addictions, this is one of the most

dangerous addictions, but turning our society’s spotlight on to how

do we help those kids who are suffering and their parents, and

what kind of supports do they need certainly would help solve this

problem, too, form the position of a doctor, and that’s what my

business is, is to try to treat suffering.

Ms. MILLER. Thank you.

I’d like to recognize Representative Lynch at this time.

Mr. LYNCH. Thank you, Madam Chair.

Just to sort of get a sense of the scope of this problem. John

McGahan and I have worked on this a while. John and I worked

together to establish the Cushing House, along with Representative

Wallace and Senator Tolman, and it houses 16 boys, 16 adolescent

males.

Originally, the Cushing House was established because we had

a suicide epidemic in the Boston area, and it was exclusively male,

and some of those suicides were heroin related, drug related.

More recently, it has become a focus of our response to the

OxyContin problem, and, John, you know, I know we talked last

week, and you were telling me about the number of people—the

number of boys in the Cushing House right now who had, I believe,

heroin addictions now, but had come to that through a prior addiction to OxyContin. Out of the 16 boys that are now residing there,

how many of them have been previously addicted to OxyContin?

Mr. MCGAHAN. All of them, every one of them.

Mr. LYNCH. OK, so 16 out of 16.

Mr. MCGAHAN. Right.

Mr. LYNCH. One of the things, the problem that has become so

pervasive now that we are in the process of constructing, unfortunately, a home for girls right next door, that will have, I think, 10

beds to start, and was supported by my Republican colleagues in

the Congress. This is one of those things where you see it as not

being a partisan issue, and so I want to just give credit to my Republican colleagues for supporting me on that request, and also the

President for signing it into law and to allow that money to go forward.

But, you said earlier in your testimony, John, that at that time

there was no test for OxyContin. Is there a test now for

OxyContin?

Mr. MCGAHAN. Yes, there is. We hate to discharge people, but we

have to, if they are positive we need to know exactly what they are

positive for and try to get them appropriate treatment, refer them

back to detox if that’s what’s needed. There is a test specifically for

OxyContin now.

Mr. LYNCH. OK.

But, what sort of struck me was, I know that Senator Tolman

and Representative Wallace, you’ve got a bill regarding emergency

room reports regarding, you know, drug interdiction and interventions. Is there some way that your legislation might actually require this test for OxyContin at the emergency room, when there’s

an overdose or, like I say, a medical intervention with an individual who, you know, has either overdosed on opiates? That would

sort of give us the size of the problem within Massachusetts directly and specifically related to OxyContin, and/or if it’s a chemiVerDate 11-MAY-2000 10:37 Jul 12, 2006 Jkt 000000 PO 00000 Frm 00098 Fmt 6633 Sfmt 6633 D:\DOCS\24947.TXT HGOVREF1 PsN: HGOVREF1
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cal-based test, I think what it does, it tests for that time-release

component that’s only present in OxyContin, and it might give us

a handle on how much of this stuff is going on.

Mr. MCGAHAN. Congressman, they are, the actual drug of overdose will be reported, but as we pointed out, this is not going to

be like I got you or I can report you, it’s going to protect identities.

Mr. LYNCH. No, no, it will be anonymous.

Mr. MCGAHAN. But, it will definitely, to the poison that is in the

system, it will be identified.

Mr. LYNCH. OK, that’s great.

Mr. WALLACE. Congressman, if I could just add something on

that point.

Mr. LYNCH. Sure, go ahead.

Mr. WALLACE. One of the bills that I filed, and I never in my

wildest dreams thought that I would have to file a bill like this,

but one of the things we’ve seen is that young kids, teenagers, 14,

15, 16, were overdosing, non-fatal overdoses, and they were being

brought to the emergency room by the EMTs, or the police, the fire,

and they were being treated and released, and their parents had

no knowledge of them even being in the hospital.

And, what happened is, one of my friends, his son got arrested

for drinking a beer at Dorchester Heights, and he had to go down

to the police station and bail him out and bring him to court the

next day, and he knew where he was, but these parents, there’s

one individual that OD’d twice in the same day, twice in the same

day, and his parents didn’t even know about it.

So, the bill that I filed was that if a child is under 18, is brought

to an emergency room, then his parents had to be notified. Again,

never in my wildest dreams did I think I’d have to do that, but

those are the depths that we have to go to, Congressman, at this

point, and it’s unfortunate.

Mr. LYNCH. Yes.

I know that this Weissman Institute, it may be Weissman, I

don’t know if I’m pronouncing that properly, but they are a fairly

reputable rehab hospital, and according to their data 44 percent of

their addicts, 44 percent of their addicts on OxyContin, were legally prescribed the drug. So, it’s not someone out on a street corner somewhere looking for a fix, it’s people who were legally and

properly, according to the loose construction we have right now,

they were just given the drug for a certain reason, and then its inherent addictive qualities, basically, dragged them down to the

point where they are addicted.

And, that’s the troubling part of this for me. I know that you are

both, both Senator Tolman and Representative Wallace, you are

working with a task force at the State level. Have you any, I know

you’ve had, I think, seven, six or seven hearings, and you’ve got

one coming up in Somerville that I’d love to come back, are there

any things that we could help you with in terms of at the Federal

level, just trying to get our arms around this thing.

I know that, I’ve got to be honest with you, the drug lobby is

very, very powerful in Washington, DC. They tell me that there are

635 pharmaceutical lobbyists in Washington. There’s only 535

Members of Congress, counting the Senate, and there are 635 lobbyists for the drug companies. They are extremely powerful, and

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they have influence with both parties, let’s be fair. And, you know,

I have found it difficult to bring them to task, and believe me, if

I could reasonably and cooperatively get them to reformulate this

drug I wouldn’t have a bill to ban it. If we could do it in a somehow

reasonable way, but I just find they are so powerful and there’s no

incentive, quite frankly, for them to change, because I think their

total take is $8 billion on this drug, $8 billion in profit on this

drug. And, that’s a powerful incentive for them not to change.

But again, my question, how do we help you? You’ve been doing

great work on this, and we might have to attack it on a state-bystate basis, given the power of the lobby in Washington.

Mr. TOLMAN. Congressman, the Representative and I are very

careful not to answer the way that DEA did, given that you are

asking the question.

You are doing it, frankly. When you talked about the $300,000

that you, Congressman, with the Republican colleagues was to get

for south Boston for that girls program that we just desperately

needed, you are doing it.

The leadership that you’ve demonstrated throughout the State,

most importantly, getting us to put in the extra $9 million to get

the $13 to match the Federal funds, that’s huge, but I think what

we have to do, when we take detox in general, and you have a person maybe with alcohol and a 5 or 7 day detox may work, the problem that we are really facing here is, we are not equipped to deal

with the opiate detox, because the opiate detox, as I refer to it as

a spin cycle, it has to be far more extensive. It has to have the

detox, but then it has to have the after care and the job training

and, of course, the self-esteem building. That’s not done in 3 to 5

days, and we are wasting our money to some extent when we are

detoxing and then just letting them get out, or letting them get out

because the programs that they need after that are just not available.

So, we need to continue the partnership with the Federal Government and the State funds, to make those programs that are

going to have a much higher success rate at beating the addiction.

I think that’s a key component which we are trying to focus with

the Bureau of Substance Abuse, the House, and the Senate, working together with the executive branch of Government, and, of

course, you as well.

So, you are doing it. We have to keep vigilant. This hearing is

a huge, in my opinion, positive benefit in the fight against this

drug, because we have to let the public know how dangerous this

is, do not touch it, do not go near it, and, you know, the way you’ve

tried to do that in the general Massachusetts area has been terrific, Congressman. So, you are doing it, but we have to continue

the partnership, I think.

And, Madam Chair, I can’t thank you enough for this effort, because we have to get the message out. When you were young, and

if you tried something, whether it was a can of beer or whatever

it was, you knew you’d never touch heroin. The problem with this

drug is, it’s heroin, but you don’t know you are touching it, and

that’s the difference, where you might have tried something that

would be less potent or less addictive, and that’s the key component, is that we have to let the public know, do not misuse this

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drug, because it will ruin your life and it will kill you, and ruin

everybody around you that loves you.

And so, you are doing it. We are going to continue partnership,

but thank you.

Mr. LYNCH. Thank you.

Representative.

Mr. WALLACE. Yes, Madam Chair, one of the things that I think

hasn’t been mentioned is that we are hearing the word heroin a lot,

and I mentioned that when I was doing my research I didn’t even

realize that it was legal in this country for 26 years, which kind

of shocked me. But, a lot of things have shocked me lately, so that’s

just one of them.

But, one of the problems that we have is, any time that you can

buy a bag of heroin for $4 a bag we are going to have problems

in this country, and that’s where it is right now. These kids can

get a bag of heroin cheaper and easier than getting a six pack. To

get a six pack they have to get someone to go in the liquor store

to get it for them, to buy a bag of heroin for $4, you can go down

the street and get it. So, I think that’s one of the inherent problems

that we have, is that it’s available, and we have to do something

along those lines.

Again, Congressman, thank you for what you’ve done for the

Cushing House and for all of us, as far as your lead on this issue.

It’s been huge, and we appreciate it.

Mr. LYNCH. Thank you.

Madam Chair, I yield back.

Ms. MILLER. Thank you.

Well, I certainly want to tell you how much sincerely we appreciate, first of all, the gracious hospitality of the city of Boston for

hosting this hearing, and all of our witnesses for coming here, and

I certainly want to echo, as well, that if it hadn’t been for Congressman Lynch this hearing would not have taken place. You

know, quite frankly, it’s much easier for us to have hearings in

Washington, because everybody is there, but in this case I thought

it was very, very important that he came to me and talked to the

members of our committee about this terrible problem that we’re

having in his district, it is important for us to be here. I’m certain

that there will be some legislation or certainly some changes as a

result of all of the testimony that we’ve heard here today.

Congressman.

Mr. LYNCH. Madam Chair, I just have one question that I forgot

to ask, and that was of John McGahan. I know you’ve got a 16 bed

boys facility, I know you are doing the same for the girls. I’m trying

to get a sense of the demand that’s out there. How many beds, I

know you’ve got a waiting list over there, how many beds do you

think you could fill tomorrow if we had them available at your

rehab facility?

Mr. MCGAHAN. We have 16 beds for boys, and we could fill 50.

I mean we let the list only get so long, because we don’t want parents to have to try to keep their kids safe for an extended period

of time. I mean, the list can get, you know, four, five, six deep, and

after that it’s just too long, because the calls come every day. I

mean, if we had a 50 bed facility, we could fill a 50 bed facility.

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We are experiencing the same thing with the girls that we did

with the boys. When we first opened it was going to be 10, 8 beds,

then it went to 10, and then we snuck in another room to make

it 12, and we are already up to putting in 12 at the girls side already, even though the original plan was 10, because the phone is

ringing off the hook. So, I said, cut a couple of feet off of each room

and jam in another room and make it 12 beds. So, I mean, we

could fill 50 at the drop of a hat.

Mr. LYNCH. OK, thank you. That may become important testimony when we try to go for further funding for the girls home and

for the boys as well in the future. I just wanted to get it on the

record.

And then, just for a matter of housekeeping, I also would ask

unanimous consent to enter into the record the GAO report that

was conducted regarding OxyContin, and I would ask unanimous

consent that be accepted as part of this record.

Ms. MILLER. Without objection.

[NOTE.—The GAO report entitled, ‘‘Prescription Drugs,

Oxycontin Abuse and Diversion and Efforts to Address the Problem, GAO–04–110,’’ may be found in subcommittee files.]

Mr. LYNCH. Thank you, Madam Chair, and again, thank you for

your leadership and your kindness to myself and to my district in

coming here. I really do appreciate working with you, and it’s been

a joy to serve on this committee.

Mr. MCGAHAN. Congressman, if I could just add one thing. In the

story, one of the things that I think is important that you bring

back and share with your colleagues is, it’s not only about these

teenagers when they are teenagers. These kids have no training,

like the Senator said, no job skills, no education. They are contracting diseases. We need to think ahead of where they are going to

be when they are 40 years old. They are not going to have an education. They are not going to have health insurance. They are going

to have criminal involvement, and they are going to have kids. This

isn’t going to go away, it’s going to get worse, and that’s what we

need to really share, is we need to say where are these 15 year old

kids going to be 25 years from now. They are going to be parents,

and that is scary, and that’s what we should be sharing.

Mr. LYNCH. Right, and I know that you’ve got a high incidence

of liver disease, and, you know, when you look at that in a 16 or

a 17 year old young person, and you realize that person is going

to be, you know, looking for a liver transplant in a matter of years,

and you see the damage that’s being done to these people over a

lifetime, you realize what the huge, huge human cost is to this

problem. So, it’s another reason for us to get our arms around it

and figure out a solution, if there is one.

Thank you, Madam Chair.

Ms. MILLER. Thanks very much again. We appreciate all of your

attendance today, and the hearing is adjourned.

[Whereupon, at 1:35 p.m., the subcommittee was adjourned.]

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