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




 
 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
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                     COMMITTEE ON GOVERNMENT REFORM

                     TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut       HENRY A. WAXMAN, California
DAN BURTON, Indiana                  TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota             CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana              ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio           DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania    DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee       DIANE E. WATSON, California
CANDICE S. MILLER, Michigan          STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio              CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California          LINDA T. SANCHEZ, California
GINNY BROWN-WAITE, Florida           C.A. DUTCH RUPPERSBERGER, Maryland
JON C. PORTER, Nevada                BRIAN HIGGINS, New York
KENNY MARCHANT, Texas                ELEANOR HOLMES NORTON, District of 
LYNN A. WESTMORELAND, Georgia            Columbia
PATRICK T. McHENRY, North Carolina               ------
CHARLES W. DENT, Pennsylvania        BERNARD SANDERS, Vermont 
VIRGINIA FOXX, North Carolina            (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           STEPHEN F. LYNCH, Massachusetts
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
MICHAEL R. TURNER, Ohio              CHRIS VAN HOLLEN, Maryland
LYNN A. WESTMORELAND, Georgia

                               Ex Officio

TOM DAVIS, Virginia                  HENRY A. WAXMAN, California
                       Ed Schrock, Staff Director
                         Dena Kozanas, Counsel
                           Alex Cooper, Clerk
                      Krista Boyd, Minority Cousel


                            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


 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.
    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.
    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:]

    [GRAPHIC] [TIFF OMITTED] T4947.001
    
    [GRAPHIC] [TIFF OMITTED] T4947.002
    
    [GRAPHIC] [TIFF OMITTED] T4947.003
    
    [GRAPHIC] [TIFF OMITTED] T4947.004
    
    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 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, 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 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 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:]

    [GRAPHIC] [TIFF OMITTED] T4947.005
    
    [GRAPHIC] [TIFF OMITTED] T4947.006
    
    [GRAPHIC] [TIFF OMITTED] T4947.007
    
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    [GRAPHIC] [TIFF OMITTED] T4947.009
    
    [GRAPHIC] [TIFF OMITTED] T4947.010
    
    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 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.
    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 sponsor 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 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.
    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 
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.
    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 
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, 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 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 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 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 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 
morphine-based 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?
    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.
    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.
    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 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, 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 
hard-hitting 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.
    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 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:]

    [GRAPHIC] [TIFF OMITTED] T4947.032
    
    [GRAPHIC] [TIFF OMITTED] T4947.033
    
    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 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.
    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.
    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 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 school, and two loving parents who both work and 
are doing their best to hold the family together. We can only 
imagine the day-to-day 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 sustained-release 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 
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.
    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 sister-in-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 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.
    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 addictions, 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 chemical-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 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-by-state 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 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.
    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.]
    [Additional information submitted for the hearing record 
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