```

[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]

                      OXYCONTIN: ITS USE AND ABUSE

=======================================================================

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                               __________

                            AUGUST 28, 2001

                               __________

                           Serial No. 107-54

                               __________

       Printed for the use of the Committee on Energy and Commerce

 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 house

                               __________

                    U.S. GOVERNMENT PRINTING OFFICE
75-754CC                    WASHINGTON : 2001

For Sale by the Superintendent of Documents, U.S. Government Printing Office
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                    COMMITTEE ON ENERGY AND COMMERCE

               W.J. ``BILLY'' TAUZIN, Louisiana, Chairman

MICHAEL BILIRAKIS, Florida           JOHN D. DINGELL, Michigan
JOE BARTON, Texas                    HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio                RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania     EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California          FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia                 SHERROD BROWN, Ohio
STEVE LARGENT, Oklahoma              BART GORDON, Tennessee
RICHARD BURR, North Carolina         PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
GREG GANSKE, Iowa                    ANNA G. ESHOO, California
CHARLIE NORWOOD, Georgia             BART STUPAK, Michigan
BARBARA CUBIN, Wyoming               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               TOM SAWYER, Ohio
HEATHER WILSON, New Mexico           ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona             GENE GREEN, Texas
CHARLES ``CHIP'' PICKERING,          KAREN McCARTHY, Missouri
Mississippi                          TED STRICKLAND, Ohio
VITO FOSSELLA, New York              DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  THOMAS M. BARRETT, Wisconsin
TOM DAVIS, Virginia                  BILL LUTHER, Minnesota
ED BRYANT, Tennessee                 LOIS CAPPS, California
ROBERT L. EHRLICH, Jr., Maryland     MICHAEL F. DOYLE, Pennsylvania
STEVE BUYER, Indiana                 CHRISTOPHER JOHN, Louisiana
GEORGE RADANOVICH, California        JANE HARMAN, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska

                  David V. Marventano, Staff Director

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

              Subcommittee on Oversight and Investigations

               JAMES C. GREENWOOD, Pennsylvania, Chairman

MICHAEL BILIRAKIS, Florida           PETER DEUTSCH, Florida
CLIFF STEARNS, Florida               BART STUPAK, Michigan
PAUL E. GILLMOR, Ohio                TED STRICKLAND, Ohio
STEVE LARGENT, Oklahoma              DIANA DeGETTE, Colorado
RICHARD BURR, North Carolina         CHRISTOPHER JOHN, Louisiana
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
  Vice Chairman                      JOHN D. DINGELL, Michigan,
CHARLES F. BASS, New Hampshire         (Ex Officio)
W.J. ``BILLY'' TAUZIN, Louisiana
  (Ex Officio)

                                  (ii)

                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Atwood, Theresa..............................................    52
    Coulter, Christine, Lieutenant, Philadelphia Police Narcotics 
      Intelligence Unit, Philadelphia, Pennsylvania..............    19
    Demarest, Andrew E., Senior Deputy Attorney General, Office 
      of Attorney General, Drug Strike Force Legal Service 
      Section, Norristown, Pennsylvania..........................    10
    Friedman, Michael, Executive Vice President, Chief Operating 
      Officer, Purdue Pharma, L.P., accompanied by Howard Udell, 
      Executive Vice President and General Counsel, and Paul D. 
      Goldenheim, Senior Physician...............................    35
    Gibbons, Diane E., Bucks County District Attorney, Office of 
      the District Attorney, Doylestown, Pennsylvania............    22
    Levy, Michael H., Vice Chairman Medical Oncology, Director of 
      Supportive Oncology, Director, Pain Management Center, Fox 
      Chase Cancer Center........................................    44
    Meehan, Patrick L., Delaware County District Attorney, Office 
      of the District Attorney, Delaware County Courthouse, 
      Media, Pennsylvania........................................    14
    Woodworth, Terrance W., Deputy Director, Office of Diversion 
      Control, Drug Enforcement Administration...................     6
Material submitted for the record by:
    Bisch, Edward J., prepared statement of......................    76
    Udell, Howard, Executive Vice President and General Counsel, 
      Purdue Pharma, L.P., letter dated September 5, 2001, 
      enclosing material for the record..........................    78

                                 (iii)

  

 
                      OXYCONTIN: ITS USE AND ABUSE

                              ----------                              

                        TUESDAY, AUGUST 28, 2001

                  House of Representatives,
                  Committee on Energy and Commerce,
              Subcommittee on Oversight and Investigations,
                                                      Bensalem, PA.
    The subcommittee met, pursuant to notice, at 12:01 p.m., in 
Bensalem Township Public Meeting Room, 2400 Byberry Road, 
Bensalem, Pennsylvania, Hon. James C. Greenwood (chairman) 
presiding.
    Members present: Representatives: Greenwood and Bass.
    Staff present: Ray Shepherd, majority counsel; Nolty 
Theriot, legislative clerk; and Chris Knauer, minority 
investigator.
    Mr. Greenwood. Good afternoon and welcome. I would like to 
thank Mayor DiGirolamo and thank the Bensalem Township for 
hosting us this afternoon and for making the municipal 
facilities available to us. It is appropriate that we be here 
today because it was in Bensalem that this issue first came to 
my attention.
    I would also like to thank the Mayor's Executive Assistant, 
Ms. Barbara Barnes, for coordinating with my staff on this 
effort and Mr. Ralph Douglas, the Chairman of The Bensalem 
Cable Advisory Board, who has arranged to tape this hearing for 
broadcast over the township's cable system. And I believe 
actually it is going out live into four different townships in 
Bucks County.
    The use and the abuse of OxyContin provides quite a dilemma 
for us in Congress and for the American public. For some, 
OxyContin is the angel of mercy; for others, it is the angel of 
death. To those who suffer severe chronic pain, it brings 
welcome relief. But for those who abuse this highly addictive 
drug, it can bring even greater suffering.
    Today, we will hear from law enforcement officials who 
argue that OxyContin is quickly becoming the abuser's drug of 
choice, surpassing heroin and cocaine in some jurisdictions.
    We will also hear from pain specialists who argue that law 
enforcement efforts and the reports of abuse in the media 
should not prevent them from obtaining this miracle drug. And I 
don't think anyone would disagree with that.
    Let me be clear. The purpose of this hearing is not to 
denounce the use of OxyContin by those who benefit from its 
palliative effects. Far from it. This medicine has clearly 
alleviated immeasurably more anguish than it has induced.
    Rather, today's hearing is the logical extension of this 
subcommittee's ongoing investigation into prescription drug 
abuse throughout the United States. My staff and I have met on 
numerous occasions with the DEA, the FDA, and Purdue Pharma in 
order to investigate the trends of OxyContin abuse and 
diversion, and well as to explore potential solutions.
    Sadly, prescription drug abuse is a growing national 
problem. According to the National Institute of Drug Abuse, as 
recently as 1999, more than 9 million Americans, aged 12 and 
older, reported that they used prescription drugs at least once 
that year for nonmedical reasons. Nor is prescription drug 
abuse a new problem.
    For example, from 1990 to 1998, the number of individuals 
initiating misuse or abuse of pain relievers increased by 181 
percent, new initiates to stimulants increased by 165 percent, 
tranquilizers by 132 percent, and the initiates into sedative 
use have increased by 90 percent. It is especially disturbing 
to note that the most dramatic increases have been found in 12 
to 17-year-olds and in 18 to 25-year-olds. There is a gentleman 
in the audience whose 18-year-old son perished after taking 
OxyContin in combination, I should say, with another drug.
    Unfortunately, Bucks County, where we now sit, is in the 
media spotlight today because of the publicity surrounding the 
arrest of Dr. Paolino, who stands accused of illegally 
dispensing prescriptions of OxyContin to anyone with $60. Bucks 
County residents purchase more OxyContin than in any other 
county in the State, with the exception of the large urban 
counties of Philadelphia and Allegheny. Nationwide, 
Pennsylvania ranks eighth in the per capita consumption of 
OxyContin.
    OxyContin is a Schedule II controlled-release form of the 
narcotic Oxycodone. It is available in 10 milligram, 20 
milligram, 40 milligram, and 80 milligram tablets. OxyContin is 
manufactured by Purdue Pharma and was introduced in January 
1996.
    Now, the 18th most prescribed drug in the United States, 
OxyContin had more than $1.2 billion in sales from May of last 
year to May of this year. OxyContin is pure Oxycodone, with no 
other active ingredients, as compared to other analgesics, such 
as Percocet, Tylox, and Percodan. The time release formulation 
allows patients 8 to 12 hours of pain relief from a single 
dose. And there is the gentleman who introduced himself to me 
today who has been taking this drug for his chronic pain and is 
delighted that it is available to him. The drug was developed 
for people with severe, chronic pain. Make no mistake though, 
in the world of pharmaceuticals, OxyContin is to prescription 
drug pain relievers what jet fuel is to unleaded gasoline.
    When administered correctly, OxyContin can be of enormous 
benefit to cancer patients and others in severe and chronic 
pain. One of the witnesses we will hear today, Pain Specialist 
Dr. Michael Levy, observes that ``OxyContin is probably one of 
the best drugs we have seen in the past 10 years and really 
helps these patients.''
    Unfortunately, the pharmacological effects of OxyContin on 
those who suffer great pain are the very features that make it 
attractive to abusers. First, it offers reliable strength in 
dosage levels, and, second, it may be covered by the abuser's 
health insurance. Abusers have discovered that the controlled 
release formula of OxyContin can be easily manipulated to 
produce a powerful, Morphine-like high.
    Law enforcement officials have criticized the drug's 
manufacturer of overly aggressive marketing practices and a 
failure to swiftly respond once the abuse of OxyContin was 
first reported in Maine in early in the year 2000.
    In fact, on August 21, 2001, Pennsylvania Attorney General 
Mike Fisher accused Purdue Pharma of continuing to use overly 
aggressive marketing practices, such as using promotional pens 
and conversion charts, urging physicians, many of whom were 
clearly not pain specialists, to prescribe OxyContin to their 
patients.
    Their campaign also included efforts to persuade doctors to 
switch patients who were receiving less addictive and less 
powerful painkillers to OxyContin.
    Recently, Purdue Pharma took some measures to prevent abuse 
of its largest revenue-garnering drug by pulling its strongest 
160-milligram OxyContin pills off the market in May.
    They also issued tamper-proof prescription pads, which 
resist copying and scanning. The pads are used by 240 doctors 
here in Pennsylvania.
    On July 25, 2001, the FDA announced that, in cooperation 
with Purdue Pharma, it was strengthening the warning and 
precautions section in the labeling of OxyContin. The changes 
include a ``black box warning,'' the strongest type of warning 
for an FDA-approved drug, and are intended to lessen the chance 
that OxyContin will be prescribed inappropriately for pain of 
lesser severity than the approved use or for other disorders or 
conditions inappropriate for a Schedule II narcotic.
    In addition, the company issued a ``Dear Health Care 
Professional'' letter which explains the changes in labeling 
and highlights the problems associated with the abuse and the 
diversion of OxyContin.
    These actions, though commendable, also appear long 
overdue. According to DEA, the number of Oxycodone-related 
deaths has increased 400 percent since 1996, the same time 
period in which the annual number of prescriptions for 
OxyContin has risen from approximately 300,000 to almost 6 
million.
    Coroners in the Philadelphia region began to see death 
rates rise last year, as OxyContin became a more popular street 
drug. Oxycodone, the drug's primary ingredient, was found in 17 
bodies in the city in 1999. The following year, the number rose 
to 41. In the first 6 months of this year, the drug was 
detected in 39 bodies and was the cause of death in 11 of those 
victims.
    In its testimony today, Purdue Pharma will argue that the 
death figures heralded by newspapers nationwide are inaccurate 
and are the prime mover of the negative hype surrounding 
OxyContin.
    The company claims that the death reports do not take into 
account the fact that in the vast majority of these cases, 
Oxycodone was detected, not OxyContin, per se. In addition, the 
company asserts that even in deaths where OxyContin was found, 
there were additional drugs present that contributed to or even 
caused the death of the individuals.
    Law enforcement officials are skeptical of the company's 
claims. The chief toxicologist in the Philadelphia Medical 
Examiner's Office of Health care states, ``Oxycodone has been 
in use for 80 years. The controlled release has not been. It is 
that elevated dose that is killing them.''
    The Delaware County coroner also argues that, ``When you 
see 2 deaths, 3 deaths, 5 deaths, and then 17 deaths, it 
doesn't take a rocket scientist to realize it is the 
OxyContin.''
    During this field hearing, the subcommittee will hear 
testimony and engage in fact-finding concerning the rise of 
OxyContin abuse from local, State, and Federal perspectives. I 
look forward to hearing how DEA is working with Purdue Pharma 
to reduce abuse and whether Federal and State law enforcement 
officials are satisfied that Purdue Pharma has done all that it 
can to reverse this dangerous and escalating cycle of abuse.
    I eagerly anticipate hearing from our local and State 
prosecutors in order to ascertain what tactics they have been 
utilizing to combat OxyContin abuse and diversion.
    And, last, I am looking forward to hearing from Dr. Levy to 
gain a better understanding of the palliative properties of 
OxyContin, and from Terry Atwood who will give us a firsthand 
account of treatment for OxyContin abuse.
    With me today, to my left, is my good friend and colleague 
from New Hampshire, Charlie Bass, who has flown down to be with 
us. He is a member of the Oversight and Investigations 
Subcommittee. And the gentleman is recognized for 5 minutes for 
an opening statement.
    Mr. Bass. And I thank the chairman for recognizing me, and 
I also want to thank you for holding this timely and important 
hearing today. Prescription drug abuse is certainly a growing 
problem in this country, and one that prescribes, if you will, 
a different solution from issues involving from the abuse of 
nonprescription drugs. I think as a subcommittee we need to 
find out what the scope of the problem is, which we will do 
today, both from the law enforcement community, as well as from 
other--from our second panel.
    And I think we need to address, and will address, perhaps 
three, perhaps more, significant issues. Firstly, what kinds of 
information do we now collect to monitor this problem, and do 
we need to have different structures and different mechanisms 
for developing this information so that we know what the scope 
of the problem is.
    Second, what responsibility should be borne by what entity 
in determining how to deal with the rise or abuse of 
nonprescription drugs? What--or abuse of nonprescription drugs. 
What responsibility to the manufacturers or distributors or 
sales agents on the other side, the doctors, the pharmacies, 
and so forth, have in making sure that these very powerful, but 
important, palliative drugs, are properly controlled and not 
abused?
    And I guess, last, I wonder what role the Federal 
Government and law enforcement community in general should 
play, if different from today, how their role should be 
changed, enhanced, in order to make--in order to resolve this 
problem, which, in my opinion, can be addressed immediately and 
proactively by this subcommittee, and potentially by the 
Congress. It is a very current issue. It is a serious issue. 
And I commend the chairman for bringing this issue to the 
attention of this subcommittee and the rest of the Congress. I 
yield back.
    Mr. Greenwood. I thank the gentleman from New Hampshire. 
For those of you in the audience who may not be familiar with 
how these processes work, I thought it might help to just put 
it in perspective. Mr. Bass and I, as well as many other 
Members of Congress, serve on the Energy and Commerce 
Committee. It has six subcommittees, one of which is the 
Oversight and Investigations Subcommittee, which I currently 
chair and on which Mr. Bass serves.
    One of our functions is to oversee those Federal agencies 
that deal with the pharmaceutical industries, such as--and drug 
issues, in general, such as the Food and Drug Administration, 
as well as the activities of DEA, as it relates to these kind 
of commercially available drugs. It is also our responsibility 
to oversee the pharmaceutical industry as a whole.
    And so that is why we are here in a fact-finding mode, to 
hear from experts from around the country and from this areas, 
as to recommendations, what their experiences have been, what 
recommendations they may have for us, so that we can take that 
information back to Washington and see if what legislative or 
administrative activities that might help to resolve this 
problem.
    We have two panels of witnesses today. The first is 
fundamentally a law enforcement panel, which is seated before 
me now. And we will hear their testimony and question them. And 
then we will bring a second panel consisting of representatives 
of Purdue Pharma, the company that makes the product, 
Representative Dr. Levy from Fox Chase Cancer Center, and we 
have an expert from the Food and Drug Administration here 
available to answer questions. And we will also work--have in 
our second panel someone who treats individuals who abuse this 
drug and other drugs.
    I will call--I will identify the witnesses who are 
presently seated at the witness table. From my right to your 
left, we have Terrance W. Woodworth, Deputy Director of the 
Office of Diversion Control, for the Drug Enforcement 
Administration, the DEA, in Washington; Andrew E. Demarest--am 
I pronouncing that right--is the Senior Deputy Attorney General 
of the Office of Attorney General, Drug Strike Force Legal 
Service Section. That is under the office of Attorney General 
Mike Fisher.
    Patrick Meehan, in the center, is the District Attorney 
from Delaware County and he is here to talk to us about his 
task force and the work he is doing in Delaware County. 
Christine Coulter is a Lieutenant with the Philadelphia Police 
Narcotics Intelligence unit; and, finally, to my left, Diane 
Gibbons, who is the Bucks County District Attorney, is with us 
today as well.
    Addressing myself to the witnesses, you are aware that the 
committee is holding an investigative hearing. And when doing 
so, we have the practice of taking testimony under oath. Do any 
of you have objectives to testifying under oath? Seeing no 
objections, the Chair then advises you that under the rules of 
the House and the rules of the committee, you are entitled to 
be advised by counsel. Do any of you desire to be advised by 
counsel during your testimony today? Seeing no responses, in 
that case, if you would rise and raise your right hand, I will 
swear you in.
    [Witnesses sworn.]
    Mr. Greenwood. So saying, you may please be seated. You are 
under oath. And I would ask you to each give a 5-minute summary 
of your testimony and we will start with Mr. Woodworth.

TESTIMONY OF TERRANCE W. WOODWORTH, DEPUTY DIRECTOR, OFFICE OF 
 DIVERSION CONTROL, DRUG ENFORCEMENT ADMINISTRATION; ANDREW E. 
 DEMAREST, SENIOR DEPUTY ATTORNEY GENERAL, OFFICE OF ATTORNEY 
 GENERAL, DRUG STRIKE FORCE LEGAL SERVICE SECTION, NORRISTOWN, 
   PENNSYLVANIA; PATRICK L. MEEHAN, DELAWARE COUNTY DISTRICT 
  ATTORNEY, OFFICE OF THE DISTRICT ATTORNEY, DELAWARE COUNTY 
COURTHOUSE, MEDIA, PENNSYLVANIA; CHRISTINE COULTER, LIEUTENANT, 
PHILADELPHIA POLICE NARCOTICS INTELLIGENCE UNIT, PHILADELPHIA, 
   PENNSYLVANIA; AND DIANE E. GIBBONS, BUCKS COUNTY DISTRICT 
    ATTORNEY, OFFICE OF THE DISTRICT ATTORNEY, DOYLESTOWN, 
                          PENNSYLVANIA

    Mr. Woodworth. Chairman Greenwood, Congressman Bass, other 
distinguished members and guests, I would like to thank you for 
the opportunity to address this subcommittee regarding 
OxyContin. Mr. Chairman, on behalf of Administrator Asa 
Hutchinson, I would like to thank the subcommittee for its 
interest and support in assisting the Drug Enforcement 
Administration with our mission of enforcing the Nation's drug 
laws.
    The Controlled Substances Act of 1970, which assigned legal 
authority for the regulation of controlled substances to the 
DEA, established five schedules into which controlled 
substances are classified according to their approved medical 
use and abuse potential. Schedule I controlled substances have 
no approved medical use in the United States and have a high 
potential for abuse, such as heroin and LSD. Schedule II 
substances, including OxyContin, are approved for medical use 
and have the highest abuse potential among controlled 
substances approved for medical use.
    OxyContin is made, as you said, by Purdue Pharma and is a 
controlled release formulation of the Schedule II narcotic, 
Oxycodone, used in treating chronic moderate to severe pain, 
when a continuous, around-the-clock analgesic is needed for an 
extended period of time. The controlled release formulation has 
an important role in the management of pain.
    From the first full year of sales in 1996, the number of 
OxyContin prescriptions has risen 18-fold, to approximately 5.8 
million prescriptions in 2000. On the other hand, another 
controlled release formulation manufactured by Purdue Pharma, 
containing Morphine, MS-Contin, saw an approximate 20-percent 
drop in prescriptions during that same period.
    During the last 2 years, DEA has noted a dramatic increase 
in the illicit availability and abuse of OxyContin. As early as 
1999, DEA assisted the State of Maine in the investigation of 
an organized ring of individuals who used forged, stolen, and 
altered prescriptions to divert thousands of dosage units of 
OxyContin to abusers. While OxyContin diversion and abuse 
appear to have begun more in rural areas, such as Appalachia, 
it now has spread to urban areas. To date, at least 14 States 
have experienced increased abuse and diversion of OxyContin, 
including the State of Pennsylvania and New Hampshire.
    The appeal of OxyContin for abusers, as you mentioned, is 
related to the larger amount of the active ingredient, 
Oxycodone, in relation to other narcotic products, and the 
ability of abusers to easily compromise the controlled release 
formulation. Simply crushing the tablet can negate the 
controlled release effect, enabling abusers to swallow or snort 
the drug for a powerful morphine-like high. The tablet can also 
be crushed, mixed with water, and injected.
    In response to the escalating diversion problem, DEA has 
embarked upon a comprehensive action plan, focused largely on 
enforcement and regulatory investigations which target key 
points of diversion, including unscrupulous or unethical 
medical professionals, forged and fraudulent prescriptions, 
pharmacy theft, and doctor-shopping.
    DEA does not intend to restrict the legitimate use of 
OxyContin, nor to prevent practitioners acting in the usual 
course of their medical practice from prescribing OxyContin for 
patients with legitimate medical needs. The Controlled 
Substance Act and DEA regulations do not attempt to define 
legitimate medical purpose, nor do they set standards as to 
what constitutes the usual course of professional practice. DEA 
relies upon the medical community to make these determinations.
    In the past, OxyContin, as you mentioned, has been marketed 
and represented as having a lower abuse potential than other 
opioid analgesics. And one component of DEA's action plan has 
been to offer FDA information on OxyContin's potential for 
abuse to assist FDA in more accurately defining the drug's 
indications for medical use.
    And, as you also mentioned, in July of 2001, FDA and Purdue 
reached an agreement regarding labeling changes and the revised 
package insert for OxyContin includes a prominent black box 
warning of the drug's abuse and diversion potential, 
highlighting the threat of serious injury or death resulting 
from its misuse. A letter calling attention to the labeling has 
been sent by Purdue to health care professionals throughout the 
country.
    Other issues discussed by DEA, FDA, and Purdue Pharma 
include providing additional information to the medical 
community on the proper use of OxyContin, as well as the 
feasibility of reformulating OxyContin in order to prevent 
its--reduce its abuse potential. On August 8, the company 
announced the development of a reformulated version and filed 
for a patent.
    DEA recognizes that the best means of preventing the 
diversion of OxyContin is to increase awareness of the proper 
use of this product, as well as its high potential for abuse. 
DEA is taking an active and measured approach to dealing with 
OxyContin abuse and diversion. At the same time, DEA is 
committed to ensuring that the valid interests of legitimate 
pain patients, and the health care community that serves them, 
are not adversely affected as a result of State, local, or 
Federal law enforcement efforts, media attention, or 
legislative or regulatory changes generated in response to the 
problems associated with OxyContin.
    Before concluding, Mr. Chairman, I would like to, on behalf 
of DEA Administrator Hutchinson, and my colleagues here in the 
DEA Philadelphia Field Division, thank our Federal, State, and 
local counterparts, both law enforcement and regulatory, 
throughout the State of Pennsylvania, as well as the U.S. 
Attorney's Offices and the District Attorney's Offices around 
the State, all of whom we have worked with very closely over 
the years in combating drug abuse, diversion, and trafficking.
    Chairman Greenwood, and, Congressman Bass, thank you very 
much for the opportunity to comment on this subject. I will be 
happy to answer questions at the appropriate time.
    [The prepared statement of Terrance W. Woodworth follows:]
Prepared Statement of Terrance W. Woodworth, Deputy Director, Office of 
           Diversion Control, Drug Enforcement Administration
    Chairman Greenwood, other distinguished members and guests, I would 
like to thank you for the opportunity to address this Subcommittee 
regarding OxyContin'. Mr. Chairman, on behalf of 
Administrator Asa Hutchinson, I would like to thank the Subcommittee 
for its interest and support in assisting the Drug Enforcement 
Administration (DEA) with our mission of enforcing the nation's drug 
laws.
    The Controlled Substances Act of 1970 (CSA) assigned legal 
authority for the regulation of controlled substances to the DEA. The 
statute charges DEA with the prevention, detection, and investigation 
of the diversion of controlled substances from legitimate channels, 
while at the same time ensuring that adequate supplies are available to 
meet legitimate domestic medical, scientific, and industrial needs.
    The CSA established five schedules into which controlled substances 
are classified according to their approved medical use and abuse 
potential. The Food and Drug Administration (FDA) is responsible for 
approving drugs for medical use and for regulating the marketing of 
drugs by industry. Schedule I controlled substances have no approved 
medical use in the United States and have a high potential for abuse. 
Schedule II substances, including OxyContin', are approved 
for medical use and have the highest abuse potential among controlled 
substances approved for medical use. Schedules III, IV and V include 
controlled substances that have a currently accepted medical use and 
have diminishing potential for abuse.
    OxyContin' was introduced by Purdue Pharma in 1995. It 
is a controlled release formulation of the Schedule II narcotic, 
oxycodone, used in treating chronic moderate to severe pain when a 
continuous, around-the-clock analgesic is needed for an extended period 
of time. The controlled release formulation has an important role in 
the management of pain where dose administration should be limited to 
twice, rather than four to six times, per day. It is currently approved 
in 10, 20, 40, 80 and 160 milligram strengths.
    From the first full year of sales in 1996, the number of 
OxyContin' prescriptions has risen 18 fold, to approximately 
5.8 million prescriptions in 2000. On the other hand, another 
controlled release formulation manufactured by Purdue Pharma containing 
morphine (MS-Contin) saw an approximate 20% drop in prescriptions 
during that same period (from approximate sales of slightly less than 1 
million prescriptions in 1996, to less than 800,000 prescriptions in 
2000). Additionally, two other new products released in the mid 1990s 
from the same manufacturer, OxyFast and OxylR, sold less than 100,000 
and 400,000 prescriptions last year, respectively.
    During the last two years, DEA has noted a dramatic increase in the 
illicit availability and abuse of OxyContin'. As early as 
1999, DEA assisted the State of Maine in the investigation of an 
organized ring of individuals who used forged, stolen, washed and 
altered prescriptions to divert thousands of dosage units of 
OxyContin' to abusers. While OxyContin' diversion 
and abuse appears to have begun in more rural areas of the United 
States, particularly Appalachia, it has now spread into urban areas. To 
date, at least fourteen States have experienced increased abuse and 
diversion of OxyContin', including the State of 
Pennsylvania.
    The appeal of OxyContin' for abusers of controlled 
substances is related to the larger amounts of active ingredient, 
oxycodone, in relation to other narcotic products, and to the ability 
of abusers to easily compromise the controlled release formulation. 
Simply crushing the tablet can negate the controlled release effect of 
the drug, enabling abusers to swallow or snort the drug for a powerful 
morphine-like high. The tablet can also be crushed, mixed with water 
and injected.
    In response to the escalating diversion problem, DEA has embarked 
upon a comprehensive action plan, focused largely on enforcement and 
regulatory investigations which target key points of diversion, 
including unscrupulous and/or unethical medical professionals, forged 
and fraudulent prescriptions, pharmacy theft, and doctor shopping. DEA 
has increased efforts to gather necessary data to better define the 
scope of the problem. Such data includes information regarding 
OxyContin' prescriptions, deaths, emergency room mentions, 
thefts, drug treatment program admissions, and forensic laboratory 
exhibits, as well as investigations, arrests and administrative 
actions. DEA has also written letters to each member of the National 
Association of Medical Examiners requesting medical examiner/autopsy, 
toxicology, and crime scene investigator reports on all deaths related 
to oxycodone in the years 2000 and 2001.
    DEA does not intend to restrict legitimate use of 
OxyContin', nor to prevent practitioners acting in the usual 
course of their medical practice from prescribing OxyContin' 
for patients with legitimate medical needs. The Controlled Substances 
Act and DEA regulations do not attempt to define ``legitimate medical 
purpose'', nor do they set standards as to what constitutes ``the usual 
course of professional practice''--the requisite elements of lawful 
prescriptions under the Controlled Substances Act and DEA regulations. 
DEA relies upon the medical community to make these determinations.
    In the past, OxyContin' has been marketed and 
represented as having a lower abuse potential than other opioid 
analgesics. One component of DEA's action plan has been to offer FDA 
information on OxyContin''s potential for abuse relative to 
other opioids, to assist FDA in more accurately defining the drug's 
indications for medical use. In July 2001, the FDA and Purdue Pharma 
reached an agreement regarding labeling changes. The revised package 
insert for OxyContin' contains a prominent ``black box'' 
warning of the drug's abuse and diversion potential, highlighting the 
threat of serious injury or death resulting from its misuse. A letter 
calling attention to the labeling change is being sent by Purdue Pharma 
to healthcare professionals throughout the country.
    Other issues discussed by DEA, FDA and Purdue Pharma include 
providing additional information to the medical community on the proper 
use of OxyContin', as well as the feasibility of 
reformulating OxyContin' in order to reduce its abuse 
potential. On August 8, 2001, the company announced the development of 
a reformulated version of OxyContin'. Purdue Pharma 
estimates that the new formulation may be marketable in three years.
    DEA has initiated meetings with the National Alliance for Model 
State Drug Laws, which has been the catalyst for the establishment of 
state prescription monitoring programs. Such programs provide a better 
mechanism to gather and evaluate prescription data, which is essential 
in responding to newly developing trends in prescription drug abuse. 
Existing data sources (IMS, Inc.) indicate that the five states with 
the lowest number of per capita OxyContin' prescriptions all 
have long standing prescription monitoring programs in place. These 
five states, beginning with the fewest per capita prescriptions for 
OxyContin' are California, Illinois, New York, Texas, and 
New Mexico. The majority of states reporting significant abuse and 
diversion issues are those without such programs. DEA has embarked on a 
number of programs to collect and monitor prescription data for 
controlled substances.
    DEA recognizes that the best means of preventing the diversion of 
OxyContin' is to increase awareness of the proper use and 
potential abuse of the product. DEA is taking an active and measured 
approach to dealing with OxyContin' abuse and diversion. At 
the same time, DEA is committed to ensuring that the valid interests of 
legitimate pain patients and the health care community that serves them 
are not adversely affected as a result of state, local or federal 
enforcement efforts, media attention or legislative or regulatory 
changes generated in response to the problems associated with 
OxyContin'.
    Before concluding, I would like to thank my colleagues at FDA for 
their cooperation in addressing this very important issue.
    Finally, Mr. Chairman, I thank you and the members of this 
Subcommittee for the opportunity to comment on this topic. I look 
forward to addressing any questions that you may have at the 
appropriate time.

    Mr. Greenwood. Thank you very much for your testimony. I 
think that the--you see these silver microphones on triangular 
stands. Those are the ones that are--need to be utilized for 
the cable television. We would now recognize--call upon Andrew 
Demarest, the Senior Deputy Attorney General, for the Office of 
Attorney General, Pennsylvania, for your testimony, sir.

                 TESTIMONY OF ANDREW E. DEMAREST

    Mr. Demarest. Thank you. Good afternoon, Chairman 
Greenwood, and, Congressman Bass, and, members. I would like to 
thank the committee for giving Attorney General Fisher's office 
an opportunity to testify today on a problem that is exploding 
in Pennsylvania right now. The abuse of the brand name 
painkiller OxyContin is rising on a tremendous scale, placing 
people who are unaware of its lethal potential in danger, and 
placing a burden on law enforcement agencies across the State 
as they try to contain the distribution. I commend the 
committee on being so quick to shed light on this new danger. 
Hopefully, by giving this matter the spotlight on this matter, 
we can stem the tide of the deaths that abuse of this drug is 
causing.
    A little background from what the State has seen on 
OxyContin--when OxyContin is prescribed, it provides effective 
pain management for cancer patients and others suffering with 
chronic pain. When properly taken, OxyContin tablet is time-
released and provides the patient with up to 12 hours of pain 
relief. The danger arises when the time-release mechanism is 
bypassed. Abusers will either chew or crush a tablet. It can be 
snorted or mixed with water, or injected, like heroin. This 
puts the drug into the system all at once to deliver an intense 
high, much like high-grade heroin.
    For example, 5 milligrams of OxyContin has the same active 
ingredient, Oxycodone, as one Percocet. So chewing or snorting 
a single 80-milligram OxyContin tablet is like taking several 
Percocet tablets all at once. Few abusers fully realize the 
enormous potency of the drug that they are taking, and, 
frankly, that is contributing to the deaths.
    When taken by a person whose body is, in any way, 
intolerant to the drug, or when taken in conjunction with other 
depressants, like alcohol, the result will be the death of the 
user. The drug slows the respiratory system. The abuser will 
lose consciousness and breathing and will eventually die. To 
date, Pennsylvania has not accumulated the total number of 
deaths linked directly to OxyContin abuse. Remember, this is 
still a relatively new phenomenon, however, the medical 
examiner of Delaware County has reported at least 17 deaths 
attributable to this drug.
    On the street, the drug sells for various prices, depending 
on the geographic location. OxyContin sells for 50 cents to $1 
per milligram. So a 40-milligram tablet, which would sell 
legitimately for $4, will bring up to10 times that amount of 
money on the street. So not only is the drug in demand by 
addicted abusers, but there is a strong profit motive in its 
illegal distribution, as we have seen.
    The distribution scheme that is illegal in the State is 
seen in the following circumstances: A doctor who fraudulently 
prescribes OxyContin to abusers for money. A pharmacist who 
illegally fills an abuser's prescription, or who forges 
prescriptions for abusers. Abusers who steal prescription pads, 
and then write their own forged prescriptions. And a phenomenon 
we call doctor-shopping. That is individuals that go from 
doctor to doctor faking illness to obtain several prescriptions 
of the same drug. Dealers or abusers also who then burglarize 
pharmacies. And we have had several armed robberies across the 
States of individuals breaking into pharmacies and seizing 
OxyContin at gun point.
    In the past 2 years, the Office of Attorney General has 
conducted nearly 100 OxyContin abuse investigations throughout 
the Commonwealth. Recently, I have just approved 10 arrest 
warrants in the last 2 weeks, and 4 of those have been for 
OxyContin. The other remaining were for other prescription 
drugs.
    Mostly notably in June, the agents of the Attorney 
General's Office arrested a Philadelphia man who illegally 
possessed over 3,000 prescription drug tablets, including a 
kilogram of OxyContin. This was nearly 900 tablets, with a 
street value of $60 per tablet. Raymond Johnson has been 
charged and is under prosecution by the Philadelphia District 
Attorney's Office.
    Additionally, there have been the other investigations that 
Congressman Greenwood has mentioned, including Dr. Paolino, and 
another one that was worked cooperatively with District 
Attorney Gibbons' office, Lewis Winokur, who is a Bucks County 
pharmacist.
    In addition to these problems, our office is addressing it 
by working cooperatively with DEA's Diversion Unit, who has 
been spectacular. As far as cooperation, they have established 
a task force in Philadelphia. We are working directly with the 
Philadelphia Police Department, the State Attorney General's 
Office, and DEA agents.
    Additionally, we are participating in regional educational 
opportunities for both law enforcement individuals and health 
care professionals. The one, which was recently held on August 
21 in King of Prussia. We can alert many of the health care 
providers to the elaborate schemes that are used for diversion 
of drugs.
    In addition, we have taken legislative opportunities with 
the State legislature. We cannot make the possession of this 
drug an offense, as was done with GHB, which became a Schedule 
I controlled substance. So we have to modulate how we attack 
the drug within the confines of legitimate scheduling of the 
drug.
    One of the main undertakings that our office has done is to 
computerize the gathering of Schedule II prescription 
information. We obtain from every pharmacy in the Commonwealth, 
on manual form right now, a prescription printout that would 
show who is obtaining OxyContin across the State. We have 
applied for and received a grant from the Pennsylvania 
Commission on Crime and Delinquency and we are now 
computerizing that data and have been in the process of doing 
that for a couple of years, due to the changing pattern of 
technology within the pharmacy environment. We now have at 
least three large chain pharmacies that are doing that with us. 
So we will be able to target the doctor-shoppers, which are a 
problem. Also, there have been legislative changes.
    And as far as working with the pharmacies and the doctors, 
we do take note that it is Pennsylvania law, according to the 
Superior Court, that every member of a health care team has a 
duty, to a limited extent, to be his brother's keeper, and we 
intend to make sure that they understand that obligation.
    Thank you, Congressman Greenwood.
    [The prepared statement of Andrew E. Demarest follows:]
   Prepared Statement of Andrew E. Demarest, Senior Deputy Attorney 
            General, Pennsylvania Office of Attorney General
    Good afternoon Chairman Greenwood, and members of the House 
Committee on Energy and Commerce. I'd like to thank the Committee for 
giving me the opportunity to testify today on a problem that is 
exploding in Pennsylvania right now. The abuse of the brand name 
painkiller OxyContin is rising on a tremendous scale--placing people 
who are unaware of its lethal potential in danger, and placing a burden 
on law enforcement agencies across the state as they try to contain its 
distribution. I commend the Committee for being so quick to shed light 
on this new danger. Hopefully, by giving the matter the spotlight this 
early, we can perhaps stem the tide of deaths that abuse of this drug 
is causing.
    Since this is such a new problem, allow me to give the Committee a 
little background on what OxyContin is and why its abuse has such 
devastating effects. OxyContin is a high potency pain killer derived 
from opium. When used as prescribed it provides effective pain 
management for cancer patients and others suffering from chronic pain. 
When properly taken, an OxyContin tablet is time-released and provides 
the patient with up to 12 hours of pain relief. The danger arises when 
that time release mechanism is bypassed. Abusers will either chew or 
crush a tablet, so that it can be snorted or mixed with water and 
injected--like heroin. This puts the drug into the system all at once 
and delivers an intense high, much like high-grade heroin. This is why 
OxyContin is sometimes referred to on the street as ``poor man's 
heroin'' or ``hillbilly heroin.''
    For example, five milligrams of OxyContin has the same active 
ingredients as one Percocet--so chewing or snorting a single 80 
milligram OxyContin tablet is like taking 16 Percocets all at once. Few 
abusers fully realize the enormous potency of the drug they are taking, 
and frankly, this is why many of them are dying. When taken by a person 
whose body is in any way intolerant to the drug, or when taken with 
other depressants--like alcohol--the result will likely be the death of 
the user. The drug slows the respiratory system. The abuser will lose 
consciousness and breathing will decrease until it eventually stops. To 
date, Pennsylvania has not accumulated the total number of deaths 
linked directly to OxyContin abuse--remember that this is still a 
relatively new phenomenon--but recently the medical examiner in 
Delaware County reported that 17 deaths last year [2000] were 
attributable to the abuse of this drug. That's a significant number, 
and I believe we can expect to see similar figures throughout the 
southeast and across the Commonwealth.
    On the street, prices for the drug vary depending on geographic 
location. But generally, OxyContin sells between 50 cents and $1 per 
milligram. So a 40 milligram tablet which sells legitimately for $4 
will bring 10 times that amount on the street. So not only is the drug 
in demand by addicted abusers, there is a strong profit motive in its 
illegal distribution. Because OxyContin is a Schedule II prescription 
drug with a very legitimate value for treating chronic pain--the 
illegal activity of getting it into the hands of abusers is centered 
around pharmaceutical diversion. The illegal distribution of the drug 
typically involves the following criminal activity:

 A doctor who fraudulently prescribes OxyContin to abusers for 
        money.
 A pharmacist who illegally fills an abuser's prescription, or 
        who forges prescriptions for abusers.
 Abusers who steal prescription pads, and then write their own 
        forged prescriptions.
 Dealers, or abusers themselves, who burglarize pharmacies.
    In the past two years, the Pennsylvania Office of Attorney General 
has conducted nearly 100 OxyContin abuse investigations throughout the 
Commonwealth. Many of these investigations have resulted in arrests, 
while others are still pending. Allow me to tell you about some of the 
recent efforts the Bureau of Narcotics Investigation has been making in 
this region of the State:

 In June, agents arrested a Philadelphia man who illegally 
        possessed over 3,000 prescription drugs, including a kilogram 
        of OxyContin. This was nearly 900 tablets, with a street value 
        of $60 per tablet. Raymond Johnson, of Elsinore St., 
        Philadelphia, was charged with illegal possession of a 
        controlled substance and possession with intent to deliver. If 
        convicted, he faces up to 15 years in prison.
 In April, we concluded an investigation into a Bucks County 
        pharmacist who was allegedly producing fraudulent prescriptions 
        in order to illegally distribute OxyContin. Lewis Winokur, who 
        practiced in a Bristol Township pharmacy, is charged with 
        filling fake prescriptions in the names of customers he 
        obtained from his pharmacy, and sold them to OxyContin abusers. 
        The names of the customer's physicians were then allegedly 
        forged by the drug addicts. Winokur was charged with 11 counts 
        of illegal delivery of a controlled substance by a 
        practitioner, and tampering with public records. He is facing a 
        maximum penalty of more than 100 years in prison and more than 
        a $1 million in fines.
 In March, our BNI agents and Bucks County law enforcement 
        officers arrested Dr. Richard Paolino, who practiced in 
        Bensalem. Our investigation alleges that Paolino's practice 
        amounted to a revolving door for OxyContin junkies. The 
        confidential informant, who worked with our agents, went to 
        Paolino's office every month to get OxyContin and Xanax without 
        ever being examined. We allege that it was standing room only 
        in Dr. Paolino's waiting room, and most of the patients were 
        gaunt, with dilated eyes. Some ``patients'' showed obvious 
        signs of withdrawal. Dr. Paolino allegedly only accepted cash 
        for office visits--$66 for the first visit, $59 thereafter. 
        Paolino was allegedly handing out so many prescriptions that 
        our office was originally alerted to the problem by a 
        Philadelphia pharmacist who was being confronted with so many 
        Paolino Oxy prescriptions that he eventually stopped filling 
        them.
    In addition to dedicating agents and resources to investigating 
specific instances of abuse, the Bureau of Narcotics Investigation will 
be operating regional educational programs for both law enforcement 
agencies and health care professionals. Since the abuse of OxyContin is 
such a new phenomenon, most local police forces lack the experience to 
properly target the problem in their communities. Health care 
professionals, such as pharmacists, also need to be educated to the 
potential this painkiller has to be diverted into a lethal street drug. 
The Office of Attorney General's experience in dealing with OxyContin 
abuse needs to be disseminated throughout the Commonwealth. For 
although the problem is particularly bad in the southeast, it will 
quickly spread.
    The first conference--which was held on August 21st in King of 
Prussia--is designed to give local law enforcement agencies training in 
dealing with this new epidemic of drug abuse. We can share our office's 
experience in attacking the problem. We can identify the abuser 
population that is likely to possess the drug. We can alert them to the 
often elaborate schemes that are used to divert this scheduled drug out 
of the hospitals and pharmacies and onto the street where it kills. For 
example, the Bucks County case I mentioned earlier involved a medical 
professional--a licensed pharmacist--manipulating the records of his 
workplace in order to duplicate legitimate prescriptions and sell them 
to drug addicts. This is not a run-of-the-mill street drug distribution 
ring with which local investigators are familiar. Medical 
professionals, as well, need to be aware of ways this dangerous drug 
can fall into the wrong hands.
    These are the actions that our office has taken and will continue 
to take in response to this new drug epidemic: targeted enforcement of 
the current drug laws and education of local law enforcement agencies. 
But you, as members of Congress, are wondering what you can do to 
assist law enforcement in fighting the problem. OxyContin presents a 
somewhat unique problem because it is a legitimate drug that--when 
properly prescribed and taken--serves as a valuable tool in treating 
chronic pain. We cannot simply make its possession an offense, as the 
Pennsylvania General Assembly did in 1999 when it made GHB a Schedule I 
controlled substance. Any attempt to deal with this problem statutorily 
must be aimed at the diversion of the drug from its intended 
pharmaceutical use to its abuse as an illicit street drug. Our office 
has offered the following legislative recommendations to the 
Pennsylvania General Assembly:

 The theft of a prescription blank or a prescription pad should 
        be a distinct offense punishable as a third degree felony. 
        Right now, the theft of a prescription blank is graded only on 
        the value of the paper--a low misdemeanor. But the potential 
        street value of the prescription drugs that can be illegally 
        obtained with just one pad of blanks can be thousands--perhaps 
        hundreds of thousands--of dollars. That is the value on which 
        the offense should be graded. Each of those little slips of 
        paper must be viewed as a significant source of revenue for the 
        OxyContin dealer, and the possible death for the addict who 
        doesn't know the danger of the drug he or she is taking.
 The outright theft of a prescription drug should be a felony 
        offense under the Controlled Substances Act. Currently, the 
        Controlled Substances Act only prohibits the obtaining of 
        prescription drugs through fraud or forgery. The simple theft 
        of these drugs is a Title 18 offense, graded on their actual, 
        legitimate commercial value--which is relatively low. The 
        penalty for stealing these drugs should reflect their potential 
        both in street value and in harm to the user.
 The practice of ``doctor shopping'' should be a distinct 
        offense under the Controlled Substances Act. Very often, 
        illicit prescriptions for drugs like OxyContin are obtained by 
        one individual who visits doctor after doctor complaining of 
        phantom symptoms. The prescriptions are then filled and the 
        dealer is in business. This practice should be recognized and 
        punished for the crime that it is.
    Again, I'd like to thank Chairman Greenwood for inviting me here 
today to testify on this new wave of drug abuse that threatens our 
communities. I believe that directing both the public's and Congress's 
attention to the abuse of OxyContin at this stage in the trend will 
help to minimize the damage it causes.
    I would be happy to answer any questions the members of the 
Committee may have.

    Mr. Greenwood. I thank you very much for your testimony. We 
now turn to Patrick Meehan, the Delaware County District 
Attorney.

                 TESTIMONY OF PATRICK L. MEEHAN

    Mr. Meehan. Good morning, Mr. Chairman, or good afternoon, 
Mr. Chairman, and good afternoon, Congressman Bass. And I want 
to thank you for giving me this opportunity to speak on behalf 
of law enforcement, but also just to speak as one who is a 
prosecutor, but a community leader. And I think that we have 
looked at this issue in Delaware County as one which is not 
just exclusively a law enforcement issue, but also one that is 
really a public health issue. And we have taken a collaborative 
approach to that problem, and I know that is something, in 
communications with your staff, that you wanted me to 
articulate more on in the 5 minutes that you have scheduled. So 
rather than be redundant with some of the information, I would 
like to focus a little bit on that.
    I have some opening observations. I think you couldn't be 
more on point with your identification of the paradox here with 
this drug. It is--and I have gotten phone calls from people who 
are using this with legitimate prescriptions who are in severe 
pain and talk about what a tremendous difference it has made to 
their lives. But we are also dealing with people who now are 
abusing it or addicted to it. We have crimes that grow out of 
that addiction.
    And, as I will demonstrate, we believe and we have seen 
verifiable proof of increased deaths in Delaware County as a 
result of it. So that paradox exists that, you know, those who 
legitimately use OxyContin fear that the recent controversy 
will mean tighter restrictions on the drugs, but abusers will 
go to great lengths, legal or illegal, to gain that powerful 
drug.
    You know, we see it come in, in a variety of different 
ways. And my greatest concern, as a prosecutor, is its movement 
into what we call the recreational use or the rave scene, so to 
speak. And there is reasons a drug like this can begin to 
ingratiate itself into that scene. I think that like Ketamine, 
GHB, and Ecstasy, what we have are some characteristics. One, 
it is a manufactured drug. And there is this perception out 
there that because it is not produced illicitly, like heroin or 
cocaine, that somehow there is some level of safety. And so 
those who are abusers are looking for the drug itself.
    But we have a significant number of kids that are 
experimenting. And they are using not just alcohol, but a whole 
bevy of drugs. And this has found its way into what we call the 
club-drug scene. And I think it is particularly dangerous 
because of our concerns of what it can do. Because it is not a 
drug that is taken intravenously, the kids don't have the same 
concern about AIDS or hepatitis contamination. I think that it 
has a salability--you know, the kids, where when it is marketed 
out there in the street, we call it the Madison Avenue side of 
the drugs--you know, there are OC's or Oxy's out there and the 
Ecstasy. These kind of manufactured drugs sound good to the 
kids and, as a result, they are not as threatening.
    And, of course, one of the things that needs to be 
understood, and I think it is accurate, it is not a drug that 
is operating solely and exclusively. While there may be some 
who are using it for the ability to be responsive to their 
addiction, what we are seeing is that the drug is often used in 
combinations with other drugs, even addicts may be using it in 
combination with alcohol or other kinds of prescription drugs.
    My biggest concern, as a prosecutor, and someone in public 
health, is the potential that it is truly a gateway drug to 
more serious abuse, and specifically heroin. And when we begin 
to deal with somebody who is addicted to heroin, we have 
significant issues, both from a public health perspective and a 
law enforcement perspective because of the associated crime 
that often is associated with the necessity, to find the money 
to pay for it.
    And what is unique about OxyContin is the fact that it sort 
of builds in something that heroin and cocaine don't. The 
market for heroin and cocaine, the illicit market, you know, 
has increasing steps, from distributors on down, and the profit 
margins are incremental.
    With Oxycodone, somebody--or, OxyContin, somebody who can 
get a $4 tablet legitimately prescribed, or get it through 
diversion or doctor-shopping, or all the things we have talked 
about, you know, gets a $40 markup out on the street. So in 
addition to feeding the addiction, there is a natural 
attraction to go after this particular drug because it helps to 
perpetuate the opportunity to feed the addiction.
    You are going to hear a lot from law enforcement about the 
issues of diversion, pharmacy robberies, other kinds of things, 
new laws that ought to be established. And I didn't want to 
necessarily go there, except to articulate one particular 
concern. And I was away in Boston just this last week, and one 
of the things that happened there is it is not just pharmacies 
up there. They had a nursing home that was raided at gun point 
late in the evening. And we have to be aware that this drug is 
not just available only in pharmacies. And I think we have got 
a particularly vulnerable population. And I have a concern that 
this is the kind of crime that could be repeated in other areas 
of the country.
    When we approached this again, we looked at it, as I said, 
I have got a responsibility to the criminal justice side, and 
we are very proactive, along with all my colleagues, looking at 
increased enforcement whenever we see a problem.
    But when we began to see a problem, we have a history over 
the last 4 years in Delaware County of identifying community-
wide problems. We have worked on the issue of school safety and 
crisis response. We went to the issue of identification of at-
risk kids. The third year, we looked at the issue of youth 
suicide in schools. And the fourth year, in consultation with 
the group that I regularly meet with once a month, which 
consists of our county medical examiner, my chief probation 
officer, the head of our Department of Public Health, the head 
of my county school system, and myself, we try to identify 
issues we think that are of community concern and 
collaboratively look at a way to approach it.
    And it was in that context that our medical examiner, Rick 
Hellman, who is a tremendously distinguished person in his own 
right and looks at his responsibility to be more than just, you 
know, dealing with death after the fact, but in a community 
health perspective--and you will see to my right what we have 
experienced in Delaware County. And I will just very briefly 
explain one small bit of it.
    What we have done over the course of time is to track a 10-
year history of Oxycodone abuse in Delaware County. And the 
medical examiner went through historically of all the records 
from the period of 1991 through the year 2001. Now, we weren't 
talking OxyContin in many of those earlier years because, of 
course, it was not a manufactured drug at that point in time. 
But we did have Percodan and Percocet, you know, the 5-
milligram tablet. And what you can see is, in our county of 
about 500,000 people, you saw an average of about 3, 4, 5 
deaths a year in which Oxycodone was one of the agents that 
attributed--that was attributed to overdose deaths.
    Mr. Greenwood. If I can interrupt you. If you take your 
seat and describe the chart, I think they will be able to hear 
you on the television, and otherwise, they won't be able to. I 
am afraid that is a technical problem we have.
    Mr. Meehan. I am sorry, Mr. Chairman. And I can do that 
from here just as easily. But as you look over the charts, 
again, what I wanted to identify for you is, as the medical 
examiner went through those statistics over a 10-year period, 
what you begin to see, almost commensurate with the 
introduction of OxyContin, and regularly into commerce, is the 
critical year of 2000, when we had 18 deaths. So the dramatic 
spike of about 4 a year to 18 deaths. And as of the first 5\1/
2\ months of the year 2001, we have had five associated with it 
at this point in time.
    We took an approach to this then that was community-wide 
and it led to each of us trying to define a way that we could 
influence the problem. We have worked with each of our health 
care providers so that we are trying to have our county medical 
society and our pharmacy association do two things. One, they 
are communicating down the lines with specific information to 
both pharmacists and to doctors in our region, giving them 
vital information about this problem. They are also trying to 
track information on how it is being used in Delaware County.
    We are working with our treatment providers to identify 
whether we are getting an increase in this kind of drug abuse. 
And I can tell you anecdotally, we have seen about a 20-percent 
increase in self-reported abuse by people who are seeking 
treatment. And we are working with our school system and others 
in a comprehensive effort to make this a critical educational 
objective this year so that throughout our school system, 
throughout our law enforcement community, what we want to try 
to do is educate people about the potential for abuse.
    And, again, the critical segment that we are trying to get 
to is that user population that might be fooled into thinking 
that there is not danger associated with recreational use of 
the drug. The abuser population is more complicated. And we are 
also talking with our folks about treatment modalities, to have 
somebody step down to--you know, once they have had that issue.
    So I wanted to show the statistics which verify the concern 
and then articulate at least what is a community-wide approach 
that we have tried to take to the problem. Thank you, Mr. 
Chairman.
    [The prepared statement of Patrick L. Meehan follows:]
   Prepared Statement of Patrick L. Meehan, Delaware County District 
                                Attorney
    Chairman Greenwood, members of the committee, ladies and gentlemen. 
Thank you for the opportunity to be here with you today to talk about a 
serious issue that effects both our public health and the fight against 
crime. That problem is the growing abuse of a legal prescription drug, 
Oxycontin.
    The drug Oxycontin has presented public officials at all levels of 
government with a unique problem. One the one hand, this drug, when 
used properly, as prescribed by a caring physician, can be a life-
enhancing solution to the severe pain suffered by people afflicted with 
debilitating injuries and diseases. On the other hand, when this 
powerful drug is abused, by being crushed or chewed and ingested, it 
can kill. This powerful drug presents such a clear paradox that a Web 
site devoted to the controversy surrounding it begs the simple 
question: Oxycontin--Savior or Killer?
    As a local prosecutor, my first and foremost concern about this 
drug is its potential to become an attractive drug of choice for 
recreational users and in particular for the young people who populate 
the ``Rave Culture.'' Prosecutors have already seen the drugs Ecstasy, 
GHB, and Ketamine become popular with recreational users because the 
abusers have deceiving themselves into thinking that they are not as 
harmful as illegal drugs such as cocaine and heroin. This deception 
occurs for a number of reasons: (1) Because these drugs are 
manufactured, not produced illicitly, abusers have a false sense of 
security in the drug's safety. (2) Because these drugs are not taken 
intravenously, abusers feels safe from AIDS or hepatitis contamination. 
(3) Prescription or chemical drugs come with what I call a ``Madison 
Avenue-type'' appeal; their scientific-sounding names raise the sense 
of excitement for the user. And lastly (4) these drugs are readily 
available. They are, after all, sold legally at the neighborhood drug 
store to anyone with a prescription.
    Oxycontin abuse by recreational users is particularly disturbing 
because the drug can become a ``Gateway'' drug to other narcotics, such 
as cocaine and heroin. Whenever a recreational user begins narcotic 
drug use, the potential for addiction is great. The recreational user 
who began narcotics with Ecstasy or Oxycontin may need to continue to 
get his high, but often finds the legal supply inadequate or 
unavailable, sometimes because of price. Oxycontin is an expensive 
drug, selling on the street for $0.50 to $1.00 per milligram. 
Prescription use calls for 2 tablets a day--each tablet, through a 
timed release, providing pain relief over a 12-hour period. Abusers 
will crush or chew the tablet to get the instant high, making the drug 
potentially lethal, but also requiring more tablets for abusers to stay 
high. Because Oxycontin may cost $40-$80 per tablet on the street, 
addicts may find it cheaper to buy cocaine or especially heroin, which 
unfortunately are easily available in Southeastern Pennsylvania.
    The abuse of prescription drugs has created issues for prosecutors 
that may require changes in the law. First, the most important function 
of law enforcement in the fight against prescription drug abuse is to 
combat the sale or ``diversion'' of the drug by a new breed of drug 
dealers. These drug dealers are not of the usual ``street--corner 
variety''. Increasingly, we are seeing doctors and pharmacists engage 
in these ``diversion'' schemes by selling sale prescription drugs to 
abusers. The Bucks County case of Dr. Richard Paolino is a perfect 
example of the professional fraud that we know exists when you have a 
product like Oxycontin, which sells on the street for $40 to $80 per 
tablet and is capable of producing such an addictive high that it is 
commonly called ``the Poor Man's Heroin.''
    As you will hear today from other speakers, Pennsylvania's Attorney 
General Michael Fischer is working with the General Assembly on 
legislative proposals to give law enforcement new tools to combat the 
diversion of prescription drugs. First, he is seeking to increase the 
criminal penalties for the theft of either prescription ``scripts'' or 
for the drugs themselves. Second, he is seeking the creation of a new 
crime to stop the practice of ``doctor shopping'' to acquire 
prescriptions. Attorney General Fischer has also been working in 
cooperation with the federal Drug Enforcement Agency (DEA) to create an 
electronic pharmacist reporting system here in Pennsylvania. These 
systems, in place in states like Kentucky, have allowed law enforcement 
to more closely monitor and catch pharmacists and doctors who 
participate in drug diversion schemes. I support their efforts and I 
hope we will see legislative action in Harrisburg on these proposals 
this fall.
    But we know that solutions to the problem of the abuse of 
prescription drugs like Oxycontin are not just matter of criminal law. 
This is a community problem, requiring collaborative efforts between 
government institutions, and in combination with civic and professional 
organizations. That is the approach we have taken in my county, 
Delaware County, which I am proud to share with you today.
    In Delaware County, the problem of Oxycontin abuse was first 
brought to our attention by the work of our Medical Examiner Dr. 
Frederick Hellman. As you can see from the accompanying charts (Chart 
1), Dr. Hellman has documented 18 deaths in our county in the year 2000 
where at the time of death the decedent had Oxycodone in their system, 
usually in combinations with other drugs that the decedent had been 
abusing. These 18 deaths represented an explosive increase in Oxycodone 
abuse in our county. We had never before had more than 5 such deaths in 
one year since the introduction of the drug Oxycontin into the 
marketplace in 1996. Yet in just the month of April of 2000 alone, 
(Chart 2) there were 6 Oxycodone related deaths in the county. We have 
attributed this increase to the growing popularity of Oxycontin as a 
drug of choice for abusers on the east coast. These numbers are proof 
that Oxycontin abuse, which first began in southern and midwestern 
states, has now moved east to the metropolitan areas of the Mid-
Atlantic States.
    When Dr. Hellman brought his findings to the attention of myself 
and members of the Delaware County Council, we decided to address the 
problem by using a collaborative interdepartmental approach. We focused 
on three goals: (1) education, (2) prevention, and (3) prosecution. For 
us in Delaware County, this was not a departure from standard practice 
but another application of our working county governmental paradigm to 
a new challenge.
    Increasingly, we in county government find ourselves challenged by 
community problems that have no easy answer. Under Pennsylvania law, it 
is the primary responsibility of county government to provide for 
systems of law enforcement and behavioral human services for our 
communities. We have found, in Delaware County, that the problems we 
deal with in law enforcement generally have a human service aspect that 
must be addressed. We have come then, over the last several years, to 
find that the most efficient and productive way to do our jobs for our 
constituents is to work together.
    We first created this collaborative paradigm in our efforts to 
combat school violence. In the spring of 1997 I brought together school 
administrator, teachers, local police, and behavioral service providers 
to work together to begin to identify issues of school safety in our 
county. In November of 1998, this working group hosted our first Safe 
Schools Summit. The result of that summit and the one that followed was 
the development of a ``Delaware County model'' of training for first 
responders to incidents of critical school violence. That model, 
developed through real school violence simulation exercises, has been 
distributed across the country in a videotape format by the National 
Tactical Officers Association (NTOA), who have endorsed this training 
model. This year we devoted our third Safe Schools Summit to the often 
overlooked issue of teen suicide and the need to identify and combat 
what is the third leading cause of death for American teenagers.
    We are now applying what we have learned by working together on 
safe schools, to the problem of Oxycontin abuse. In July, I held a 
press briefing along with Dr. Hellman to begin the educational campaign 
about Oxycontin. Our County Council later dedicated a public meeting to 
the issue and has since required all county agencies to work together 
to identify abusers who come into our offices for behavioral treatment. 
County Council also has produced a public informational flier on the 
dangers of Oxycontin. To further our goal of prevention through public 
education, we are getting that flier to our county agencies and to such 
groups as the Delaware County Medical Society.
    The next, and perhaps most vital step in our county campaign 
against Oxycontin abuse, is the educational effort we will undertake 
this fall in our schools to raise the awareness of our young people to 
of the danger of this drug's abuse. As we all know, many students 
unfortunately begin experimenting with recreational drugs at an age 
when they possess a misguided sense of invincibility about such 
dangerous things. It is for their protection that we will be devoting 
our next Safe Schools Summit to the overlooked issue of prescription 
drug abuse.
    My hope is that our Delaware County collaborative approach to 
combating oxycontin abuse will be a model for other counties to follow, 
as they face this issue important public health issue, and I thank the 
members of this committee for their time and attention today.

    Mr. Greenwood. Thank you, Mr. Meehan. Thank you for your 
testimony and for being with us. Next, we will hear from 
Christine Coulter, Lieutenant, Philadelphia Police Narcotics 
Intelligence Unit. Thank you for being with us, and the floor 
is yours.

                 TESTIMONY OF CHRISTINE COULTER

    Ms. Coulter. Good afternoon, Chairman Greenwood, Mr. Bass, 
members of the committee. I am honored to be here to speak to 
you on behalf of the Philadelphia Police Department regarding 
the abuse of OxyContin in the communities we serve. I must 
admit that prior to the fall of 2000, I knew very little about 
OxyContin. In the months to follow, there was a concerted 
effort made by my colleagues and myself to learn all that we 
could so we could better combat this emerging problem.
    I will leave the medical testimony for the medical 
professionals regarding the legitimate use of OxyContin. I am 
here today to testify solely about the drug's abuse in 
Philadelphia and our surrounding counties and the law 
enforcement efforts to combat this problem.
    The effects of this abuse has been devastating to many 
families and communities in our area. The increase in deaths in 
Philadelphia where there was a presence of Oxycodone in the 
body is quite alarming. The Office of the Medical Examiner 
reported 17 cases in 1999, 41 cases in 2000, and, in June of 
2001, there are already 39 reported cases. If this trend 
continues, it will likely result in the death toll from abuse 
doubling in 2 consecutive years.
    Although Oxycodone is present in other substances of abuse, 
and there were indications that other pills and alcohol were 
also contributing factors, we would be remiss in not reacting 
to the increase with a sense of urgency.
    The abuse of OxyContin in Philadelphia is a rather recent 
development. Beginning last year, we began to experience some 
problems that our fellow law enforcement officers in 
surrounding areas have dealt with for quite some time. The 
migration to the city and surrounding suburbs happened quickly, 
necessitating the development of a strategy that would stem the 
tide of OxyContin abuse. We had to quickly examine the areas of 
diversion so we could implement a suitable plan to combat 
abuse.
    An analysis was done and it was determined that there were 
three major diversions present in our city. The first is the 
outright theft of the product, or prescription pads, from 
legitimate patients, pharmacies, or practitioners. These thefts 
were committed by relatives, employees, and, in some instances, 
robbers and burglars.
    Second, individuals without legitimate medical necessity 
can obtain OxyContin by reporting made-up symptoms of pain to 
unwary, uneducated, or disinterested practitioners. This method 
is a low-risk alternative for pill diverters, since 
prescriptions is issued in the person's name, often at a low-
cost as well, since medical insurances normally cover most of 
the cost of the pill. This also engenders the practice of 
doctor-shopping, going from one doctor to another, giving the 
same complaint, and getting the medications repeatedly 
described. It is not uncommon to do so using multiple names and 
prescription plans and having the prescriptions filled at 
multiple pharmacies to camouflage this fraudulent practice.
    The third and often largest diversion method are pill-mill 
operations, where corrupt doctors or pharmacists conspire with 
pill traffickers to write or fill fraudulent prescriptions for 
ghost patients and then selling the drug on the street at up to 
100 percent profit. There is also the presence of insurance 
fraud in this diversion method, as health plans, both private 
and governmental, are billed by providers for falsely reported 
office treatments and prescriptions dispensed.
    High volume operations, such as pill-mills, lend themselves 
to tracking by audits of physician records and pharmacy orders 
of commonly abused controlled substances such as OxyContin Drug 
diversion agents from both the Drug Enforcement Administration 
and the Pennsylvania Attorney General's Office, Bureau of 
Narcotics Investigations and Drug Control, have the ability to 
administratively inspect and analyze such records. There is 
currently a tremendous amount of cooperation with these 
agencies, which enables us to build strong cases, while 
eliminating duplication of effort and wasted resources.
    Local law enforcement, however, does not presently have the 
authority to administratively subpoena prescription records. 
Enabling local police officers to analyze these records will 
encourage a more proactive investigation of drug diversion 
conspirators on the local level. Coupled with aggressive 
prosecution and enhanced sentencing of licensed health care 
professionals engaged in prescription drug diversion schemes, 
it may also discourage such corrupt practices. There is also a 
need for legislation to make all pharmaceutical thefts a 
felony, factoring in the street value of the drug into the 
equation.
    There was also a great need to train our officers, as well 
as educate health care providers and the public alike. Training 
bulletins were prepared for our officers and seminars were 
attended to gain insight to the problems associated with 
OxyContin abuse. In an effort to better educate the public, the 
police department incorporated OxyContin, as well as other 
prescription drugs of abuse, into its Heroin Education and 
Dangerous Substance Use Prevention, or HEADS-UP program, which 
educates middle to high-school age children, as well as parents 
and community groups, in an hour-long presentation by police, 
recovering addicts, and surviving family members of overdose 
victims. Since April of 2001, this program was presented to 
over 11,500 people.
    There are currently significant investigations being 
conducted by the Philadelphia Police Department and by joint 
task forces with local, State, and Federal agents that deal 
with OxyContin diversion. This is, however, a problem that we 
cannot arrest our way out of. It will require a balanced blend 
of prevention, treatment, and enforcement. It will also require 
legislative changes to act as strong deterrents. There have 
already been too many deaths. The attention that this committee 
will hopefully bring to this problem is just the beginning of 
the concerted effort needed to prevent future escalation. I 
thank you for your attention, and I will be available to answer 
any follow-up questions you may have.
    [The prepared statement of Christine Coulter follows:]
Prepared Statement of Christine Coulter, Philadelphia Police Department
    Good Afternoon, Mr. Chairman, honorable members of the Committee. I 
am Christine Coulter of the Philadelphia Police Department's Narcotics 
Bureau. I am assigned to the Narcotics Intelligence Squad. I am honored 
to be here today to speak to you on behalf of the Philadelphia Police 
Department regarding the abuse of Oxycontin in the communities we 
serve. I must admit that prior to the fall of 2000 I knew very little 
about Oxyconyin.
    In the months to follow there was a concerted effort made by my 
colleagues and myself to learn all that we could so we could better 
combat this emerging problem.
    I will leave the medical testimony for the medical professionals 
regarding the legitimate use of Oxycontin. I am here today to testify 
solely about the drug's abuse in Philadelphia and our surrounding 
counties, and law enforcement efforts to combat this problem. The 
effects of this abuse has been devastating to many families and 
communities in our area.
    The increase in deaths in Philadelphia where there was a presence 
of Oxycodone in the body is quite alarming. The Office of the Medical 
Examiner reported 17 cases in 1999, 41 cases in 2000, and as of June 
30th, 2001 there were already 39 reported cases. This will likely 
result in the death toll from abuse of this drug doubling in two 
consecutive years. Although Oxycodone is present in other substances of 
abuse, and there were indications that other pills and alcohol were 
also contributing factors, we would be remiss to not react to the 
increase with a sense of urgency.
    The abuse of Oxycontin in Philadelphia is a rather recent 
development. Beginning last year we began to experience some of the 
problems that our fellow law enforcement officers in the surrounding 
areas have dealt with for quite some time. The migration to the city 
and surrounding suburbs happened quickly, necessitating the development 
of a strategy that would stem the tide of Oxycontin abuse. We had to 
quickly examine the areas of diversion so we could implement a suitable 
plan to combat abuse.
    An analysis was done and it was determined that there were three 
major methods of diversion present in our city. The first is the 
outright theft of the products, or prescription pads, from legitimate 
patients, pharmacies, or practitioners, by relatives, employees, or 
others, including burglars and robbers.
    Second, individuals without legitimate medical necessity can obtain 
Oxycontin by reporting made-up symptoms of pain to an unwary, 
uneducated, or disinterested practitioner. This method is a low-risk 
alternative for the pill diverter, since the prescription is issued in 
the person's name, and often low cost as well, since medical insurance 
normally covers most of the cost of the pill. This also engenders the 
practice of ``Doctor-Shopping'', going from one doctor to another, 
giving the same complaint, and getting the medications repeatedly 
prescribed. It is not uncommon to do so using multiple names and 
prescription plans, and having prescriptions filled at multiple 
pharmacies to camouflage the fraudulent practice.
    The third and often the largest diversion method are ``pill-mill'' 
operations, whereby corrupt doctors and/or pharmacists conspire with 
pill traffickers to write or fill fraudulent prescriptions for 
``ghost'' patients, and then selling the drugs on the street at up to 
100% profit. There is also the presence of insurance fraud in this 
diversion method, as health plans both private and governmental are 
billed by providers for falsely reported office treatments and 
prescriptions dispensed.
    High volume operations such as ``pill-mills' lend themselves to 
tracking by audits of physician records and pharmacy orders of commonly 
abused controlled substances such as Oxycontin. Drug Diversion Agents 
of both the Drug Enforcement Administration and the Pennsylvania 
Attorney General's Office, Bureau of Narcotics Investigation and Drug 
Control have the ability to administratively inspect and analyze such 
records. There is currently a tremendous amount of cooperation with 
these agencies, which enable us to build strong cases, while 
eliminating duplication of efforts and wasted resources. Local law 
enforcement, however, do not presently have the authority to 
administratively subpoena prescription records. Enabling local police 
officers to analyze these records will encourage a more proactive 
investigation of drug diversion conspirators on the local level. 
Coupled with aggressive prosecution and enhanced sentencing of licensed 
health care professionals engaged in prescription drug diversion 
schemes, it may also discourage such corrupt practices. There is also a 
need for legislation to make all pharmaceutical thefts a felony, 
factoring in the street value of the drug into the equation.
    There was also a great need to train our officers as well as 
educate health care providers and the public alike. Training bulletins 
were prepared for officers and seminars were attended to gain insight 
into the problems associated with Oxycontin abuse. In an effort to 
better educate the public, the police department incorporated Oxycontin 
as well as other prescription drugs of abuse into its Heroin Education 
and Dangerous Substance Use prevention (or HEADS-UP) program, which 
educates middle to high school age children, as well as parent and 
community groups, in hour long presentations by police, recovering 
addicts, and surviving family members of overdose victims. Since April 
of 2001 this program was presented to over 11,500 people.
    There are currently several significant investigations being 
conducted by the Philadelphia Police Department and by joint task 
forces with local, state, and federal agents that deal with Oxycontin 
Diversion. This is however a problem that we cannot arrest our way out 
of. It will require a balanced blend of prevention, treatment, and 
enforcement. It will also require legislative changes to act as a 
strong deterrent. There have already been too many deaths. The 
attention that this committee hopefully will bring to the problem is 
just the beginning of the concerted efforts needed to prevent further 
escalation. I thank you for your attention. I am available for any 
follow-up questions you may have.

    Mr. Greenwood. Thank you very much for your testimony that 
you bring us today, as well. And our final witness on this 
panel is our Bucks County District Attorney, Diane Gibbons. 
Thank you for joining us.
    Ms. Gibbons. Thank you, Mr. Greenwood, and, Mr. Bass.
    Mr. Greenwood. The floor is yours.

                  TESTIMONY OF DIANE E. GIBBONS

    Ms. Gibbons. Bucks County, Pennsylvania, like so many 
communities across this State and this country, has experienced 
a virtual explosion of the abuse of the prescription pain 
reliever OxyContin. As District Attorney of Bucks County, I 
have witnessed firsthand the sudden influx of OxyContin and the 
corresponding devastating effects this drug has had--has begun 
to have on our community.
    As has already been said, OxyContin is intended to be a 
pain reliever for cancer patients and others suffering from 
long-term debilitating pain. Its potency and time-release 
design have made OxyContin more effective and desirable to 
these patients. The popularity of the drug for legitimate 
purposes is understandable and even compelling. But it is this 
same potency that has become attractive to drug abusers. This 
drug has become the drug of choice among an increasing number 
of drug addicts who are drawn to its instantaneous heroin-like 
high. Drug abusers will risk death to experience this high the 
drug produces.
    Since January of 2000, Bucks County has experienced 14 
overdose deaths involving OxyContin. The drug is extremely 
addictive and will, as with all addictive substances, create 
new drug addicts if overly or improperly prescribed. In 
addition to its popularity among drug abusers, the high mark-up 
on the streets makes OxyContin attractive to drug traffickers 
as well. The retail cost of a 100-tablet prescription bottle 
containing 40-milligram tablets of OxyContin, is $400. The 
pills in that same prescription bottle sold on the street, are 
worth $4,000.
    The abuse of OxyContin has brought with it a new kind of 
drug dealer to our neighborhoods. This drug is not manufactured 
in home laboratories like methamphetamine. It is not smuggled 
across our borders like heroin or cocaine. This drug is 
produced by a legitimate pharmaceutical company. It is 
prescribed by medical doctors. It is distributed by 
professional pharmacists. These are the professionals that we, 
as lay people, have come to trust and believe in. Recently, the 
citizens of Buck County have experienced two separate incidents 
that have left the foundation of this trust badly shaken.
    In March of this year, acting in a cooperative effort with 
the Attorney General, DEA, and other local law enforcement 
authorities, we arrested a physician operating out of Bensalem 
Township, Bucks County, on drug dealing, forgery, practicing 
without a license charges. This ``physician'' is charged with 
having written 1,200 prescriptions for OxyContin over a 5-month 
period. We recently charged the same physician with 1,392 
counts of insurance fraud for fraudulently submitting claims 
for reimbursement from Medicare and Blue Cross in the amount of 
$173,892.10.
    Despite the fact that this doctor's license to practice 
medicine had both expired and was suspended, large numbers of 
people were able to obtain OxyContin by merely asking for a 
prescription. One prescription bottle with this doctor's name 
on it was found in the possession of an overdose victim in 
Philadelphia. Following his arrest--and this--I refer to Dr. 
Paolino--the OxyContin overdoses in that area of Philadelphia 
immediately ceased. Despite the expired and suspended status of 
his license, Dr. Paolino was able to receive reimbursement from 
both Medicare and Blue Cross in the amount of $107,702.
    In April of 2001, in another joint investigation, a 
pharmacist was arrested and charged with forging prescriptions, 
the majority of which were for OxyContin. Again, hundreds of 
these illegal prescriptions were generated, thereby allowing 
this illegal and deadly drug to make its way to our streets.
    A third and very frightening incident occurred on August 9 
of 2001, in Bristol Township, Bucks County. On that date, a 
man, armed with a knife, entered a pharmacy, held a knife to 
that pharmacist and demanded that the pharmacist turn over 
three bottles of OxyContin. Fortunately, the pharmacist was 
able to flee the store without injury while the armed robber 
collected the drugs that he sought.
    Too often, as a society, we think that drug abuse and drug 
addiction is someone else's problem, not ours. Those of us here 
and those of us in law enforcement understand that nothing 
could be further from the truth. These three incidents, which 
occurred at Bucks County over the last 6 months, indicate the 
kind of criminal activity OxyContin has created, not only here, 
but on a national level as well. But they do not demonstrate 
the whole picture.
    Drug addicts, by definition, must become criminals to 
support their habit. The tremendous costs to support the 
addiction leads to a host of crimes--theft, forgery, credit 
card fraud, robbery, burglary, and murder. Drug dealers engage 
in a host of crimes beyond the sale of controlled substances in 
order to protect their drug territory.
    The people of Bucks County and across the Nation will 
suffer the impact of the abuse of this drug, not only as 
victims of crimes, but in the cost of insurance and the cost of 
retail goods and the added expense to the criminal justice 
system for arrest, investigation, prosecution, and treatment.
    The reaction of law enforcement must be swift and strong in 
identifying, arresting, prosecuting, and convicting those 
involved in the distribution and use of this dangerous drug. My 
office and every other law enforcement agency in Bucks County 
and in the Commonwealth of Pennsylvania, are committed to 
utilize every resource available to combat this killer. But the 
criminal justice system alone cannot solve this problem. It 
will require the cooperative effort of the pharmaceutical 
industry, medical practitioners, pharmacists, the insurance 
industry, and government to fully regulate and control the 
distribution of this extremely dangerous drug.
    In conclusion, I want to say this--law enforcement has 
worked very closely to stem the tide of this problem in Bucks 
County. All the officers, the law enforcement officers here 
today, worked with me on all the cases that I mentioned. What 
has not occurred is that the medical profession, the 
prescription--the pharmacists, the insurance companies have not 
worked together to share information. Dr. Paolino was able to 
engage in his criminal conduct for 5 months without detection 
because we do not share information about prescriptions, what 
doctors are writing prescriptions, and how many prescriptions 
those doctors are writing. So I think there is an answer to 
this problem. Thank you very much.
    [The prepared statement of Diane E. Gibbons follows:]
   Prepared Statement of Diane E. Gibbons, District Atttorney, Bucks 
                                 County
    Bucks County, Pennsylvania, like so many communities throughout the 
country has experienced a virtual explosion of the diversion and abuse 
of the prescription pain reliever OxyContin. As District Attorney of 
Bucks County, I have witnessed first hand the sudden influx of 
OxyContin and the corresponding devastating effects that this drug has 
begun to have our community.
    OxyContin is intended to relieve the pain of cancer patients and 
others suffering from long-term debilitating pain. Its potency and 
time-release design make OxyContin more effective and desirable to 
these patients. The popularity of the drug for legitimate purposes is 
understandable and even compelling. But it is this same potency that 
has become attractive to drug abusers. This drug has become the drug of 
choice among an increasing number of drug addicts who are drawn to the 
instantaneous ``heroine-like'' high the pill produces. Drug abusers are 
willing to risk death to experience the high the drug produces. Since 
January of 2000, Bucks County has experienced fourteen overdose deaths 
involving OxyContin in combination with other controlled substances. 
This drug is an extremely addictive drug and will, as with all 
addictive substances, create new drug addicts if overly or improperly 
prescribed. In addition to its popularity among drug-abusers, the high 
mark-up on the streets makes OxyContin attractive to drug traffickers. 
The retail cost of a 100-tablet prescription bottle of 40-milligram 
tablets of OxyContin is $400. The pills in that same prescription 
bottle, sold on the streets, are worth $4,000.
    The abuse of OxyContin has also brought with it a new kind of drug 
dealer to our neighborhoods. This drug is not manufactured in home 
laboratories like Methamphetamine or smuggled across our boarders like 
Heroine and Cocaine. This drug is produced by a legitimate 
pharmaceutical company, prescribed by medical doctors and distributed 
by professional pharmacists. These are the professionals that we, as 
lay people, have come to trust and believe in. Recently, the citizens 
of Bucks County have experienced two separate incidents that have left 
the foundations of this trust badly shaken.
    In March of this year, acting in a cooperative effort with the 
Attorney General of Pennsylvania, Mike Fisher, we arrested a physician 
operating out of Bensalem Township, Bucks County, on drug dealing, 
forgery and practicing without a license charges. This ``physician'' is 
charged with having written over 1,200 prescriptions for OxyContin over 
a five-month period. We recently charged the same ``physician'' with 
1392 counts of insurance fraud for fraudulently submitting claims for 
reimbursement from Medicare and Blue Cross in the amount of 
$173,892.10. Despite the fact that this doctor's license to practice 
medicine had both expired and been suspended, large numbers of people 
were able to obtain OxyContin by merely asking for a prescription. One 
prescription bottle with this doctor's name on it was found in the 
possession of an overdose victim in Philadelphia. Following his arrest, 
the OxyContin overdoses in that area of Philadelphia immediately 
ceased. Despite the expired and suspended status of his license, this 
doctor was able to receive reimbursement from both Medicare and Blue 
Cross in the amount of $107,702.
    In April of 2001, in another joint investigation with the Office of 
the Attorney General, a pharmacist was arrested and charged with 
forging prescriptions the majority of which were for OxyContin. Again, 
hundreds of these illegal prescriptions were generated thereby allowing 
these illegal and deadly drugs to make their way to the streets.
    A third and very frightening incident occurred on August 9, 2001 in 
Bristol Township, Bucks County. On that date, a man armed with a knife, 
entered a pharmacy, pointed the knife at the pharmacist's throat and 
demanded that he turn over three bottles of OxyContin. Fortunately, the 
pharmacist was able to flee the store without injury while the armed 
robber collected the drugs he sought.
    Too often, as a society, we think of drug abuse and addiction as 
somebody else's problem, not ours. Those of us in law enforcement know 
that nothing could be further from the truth. These three incidents, 
which occurred in Bucks County over the last six months, indicate the 
kind of criminal activity OxyContin has created not only here but also 
on a national level. But they do not demonstrate the whole picture. 
Drug addicts by definition must become criminals to support their 
habit. The tremendous cost to support the addiction leads to a host of 
crimes--theft, forgery, credit card fraud, robbery, burglary and 
murder. Drug dealers engage in a host of crime beyond the sale of 
controlled substances as they try to protect their territory. The 
people of Bucks County and across the nation will suffer the impact of 
the abuse of this drug not only as victims of crime but in the cost of 
insurance and retail goods and the added expense to the criminal 
justice system for investigation, prosecution, incarceration and 
treatment.
    The reaction of law enforcement must be swift and strong in 
identifying, arresting, prosecuting and convicting those involved in 
the distribution and use of this dangerous drug. My office and every 
law enforcement agency in Bucks County are committed to utilize 
whatever resources are available to combat this killer. But the 
criminal justice system alone cannot solve this problem. It will 
require the cooperative effort of the pharmaceutical industry, medical 
practitioners, pharmacists, the insurance industry and government to 
fully regulate and control the distribution of this extremely dangerous 
drug.

    Mr. Greenwood. And thank you very much for your testimony. 
We appreciate it. The Chair now recognizes himself for 10 
minutes for the purpose of questioning the witnesses. And let 
me start, if I might, with Mr. Woodworth. According to the DEA, 
since its introduction in 1996, OxyContin prescriptions have 
increased by 1,800 percent to 6 million in the year 2000. How 
do you account for this incredible growth of sales in only 4 
years, and do you think that Purdue Pharma's marketing 
techniques are a factor in this dramatic rise?
    Mr. Woodworth. Thank you, Mr. Chairman. The product was 
new. So I think a significant factor is the newness of the 
product. It's a very valuable, legitimate medication, used in 
the treatment of pain. And I am sure that that is a significant 
factor that contributed to the rapid increase in sales from 
about 360,000 to, as you say, just under 6 million 
prescriptions.
    I do think that the marketing played a significant role. 
And coupled with the marketing, was the message. And the 
message was that this substance was less abusable than other 
opioids. And, as defined by the Controlled Substances Act, a 
Schedule II substance, which all your stronger narcotics are in 
Schedule II, they have a high potential for abuse, severe 
physical and psychological dependence characteristics.
    Mr. Greenwood. Let me interrupt you for a second. Would you 
elaborate on the message that you said that Purdue Pharma 
communicated to the physicians that this was a less abusable 
drug? What was the argument there?
    Mr. Woodworth. In fact, in their label, which has now being 
changed, I believe the language was delayed absorption is 
believed to reduce the abuse liability, and messages like that. 
We also have indicators from--about Purdue salesman indicating 
that the substance has less abuse and should not be a Schedule 
II controlled substance. And that message is inaccurate because 
this is a Schedule II and it meets the definitions by law. I 
think that was a contributing factor.
    Mr. Greenwood. Also according to the DEA, emergency 
department reports involving Oxycodone, the generic active 
ingredient, had increased 200 percent since 1996. In addition, 
coroner reports involving Oxycodone have increased 400 percent 
since 1996. Do you know how much of this is attributable to 
OxyContin?
    Mr. Woodworth. No, sir. We don't. The time period that we 
utilized was the same time period that the product has been on 
the market, from 1996 to 1999. And I can give you some 2000 
figures for emergency room mentions. The 200 percent was 
inaccurate. It increased from 3,190 mentions in 1996 to 6,429 
in 1999. It is a doubling. The ME's was from 51 to 267, 400-
percent increase.
    The emergency department mentions, for a number of years, 
from 1988 to 1996, have run fairly stable, about 1,000 mentions 
per quarter. And in 1996, you see them shoot up. And then in 
2000, there were 10,800 emergency mentions. So this is----
    Mr. Greenwood. Re-read those numbers again. Between 1988 
and 1996--and define what you mean by a mention in an emergency 
department.
    Mr. Woodworth. Actually, an episode is the correct term. 
This is the Drug Abuse Warning Network that is managed by the 
Department of Health and Human Services, Substance Abuse and 
Mental Health Services Administration. And an emergency 
department episode is largely self-reported, where someone goes 
to the emergency room and they are asked the drug that they are 
on. The mentions from 1988 through 1996 were roughly 1,000 per 
quarter during that time period. And in 1996, as I mentioned, 
they went to 3,190. And then they increased in 1999 to 6,429. 
And in 2000, they are at 10,825, I believe.
    Mr. Greenwood. So a tenfold increase in the number of times 
that Oxycodone----
    Mr. Woodworth. The base substance, Oxycodone.
    Mr. Greenwood. [continuing] Oxycodone is referenced in a 
visit to. It comes up in a conversation with someone brought to 
the emergency room. In other words, what drugs did you take 
before you were brought here semiconscious or unconscious and 
so forth. So we have these numbers of deaths, but we are seeing 
a tenfold increase. And obviously a lot of people abuse this 
drug, overdose from this drug, and that doesn't result in their 
death. They are coming to the emergency room in various 
conditions, a tenfold increase in seeing the presence of this 
drug associated with emergency room visits. Is that right?
    Mr. Woodworth. Emergency room, emergency department 
episodes. Yes, sir. On the deaths, in the DAWN system, it was 
just 51 in 191996, and then 267 in 1999. DEA is writing to each 
medical examiner throughout the country to obtain the autopsy 
and toxicology reports and the crime scene investigation in 
order to see if we can more accurately determine whether the 
percentage of Oxycodone deaths that were attributable to 
OxyContin.
    Mr. Greenwood. You have been quoted in the press as being 
highly critical of Purdue Pharma's slow response to the abuse 
of OxyContin. In particularly, when asked if the company should 
have investigated adding antagonists to OxyContin to prevent 
abuse, you stated, ``It should have dawned on them sooner.'' 
What should the company have done sooner to prevent all this 
abuse?
    Mr. Woodworth. Well, I have been involved in this business 
for 30 years, working with the pharmaceutical industry here in 
the United States for that entire time. Purdue is an 
outstanding company and they have been in business making pain 
medications for a long time. They possess some of the best 
scientific and pharmaceutical knowledge and expertise that 
exists in the world. I just find it very difficult to believe 
that that situation wasn't addressed earlier.
    Mr. Greenwood. Can you elaborate on that? What might they 
have done? My question to you is what should they have done 
sooner? Is there any question in your mind that they knew that 
they had a problem early on, prior to the year 2000? For 
instance, that they knew that this drug was being abused in 
unprecedented levels? That this drug was causing death? That 
this drug was on the streets? Any question in your mind that 
the company should have known that, certainly, 2 years ago?
    Mr. Woodworth. There certainly was no question in my mind, 
and I believe that that would be the same case for Purdue 
Pharma.
    Mr. Greenwood. That they were aware of it. How long have 
you personally been aware of the fact that this drug was having 
an alarming rate of abuse?
    Mr. Woodworth. Well, it is difficult to define alarming. 
Now, DEA had a case in 1996, soon after it came on the market, 
in Richmond, Virginia. Another three or so cases in 1998. In 
1999, a half dozen, including some here in Pennsylvania. And 
then 37 in 2000, and now we are up to 168 cases. And that is 
just DEA at the Federal level. It doesn't include our State and 
local counterparts.
    Mr. Greenwood. Let me turn to this side of the table to 
District Attorney Gibbons. You have characterized distributors 
of OxyContin as ``a new kind of drug dealer.'' And while you 
cite the recent arrests of a doctor and a pharmacist, are these 
abuses by such professionals isolated incidences or do you have 
reason to believe that this is more common?
    Ms. Gibbons. It is not going to be isolated. I mean, this 
is a drug that is not manufactured by lay people. It is not 
made in local labs. It is not grown. It is not imported. For 
this drug to be abused, it must come from a legitimate source. 
It must come from the manufacturer or from a doctor or from a 
pharmacist. The mere fact that we have seen this amount of this 
drug on the street, means that that is, in fact, happening. And 
it is not one doctor in Bensalem, Bucks County, but the number 
of pills that are causing these numbers of deaths on--in the 
market. Of course, there is going to be prescription fraud, 
but, as we have seen, pharmacists have conspired with that. 
There will be robberies to commit these crimes. Bucks County 
has not seen so much a forcible crimes to obtain the pills, so 
much as a greedy distribution of these pills on the street for 
money.
    Mr. Greenwood. Let me yield 10 minutes to the gentleman 
from New Hampshire, Mr. Bass.
    Mr. Bass. Thank you very much, Mr. Chairman. Ms. Gibbons, I 
note that you mentioned in your testimony that this drug has 
the potential to have a devastating impact, and I agree with 
you, also tempered by the fact that it has provided, as you 
well understand, tremendous relief to perhaps hopefully many 
more people. You also mentioned that--an example that there was 
a physician that wrote 1,200 prescriptions. Now, that is not 
really the fault of the drug company necessarily directly.
    In your opinion, what action do you think should have been 
taken and should be taken, or a corrective action to be taken 
to prevent this sort of thing from happening again, and 
starting, perhaps, with the manufacturer and going down 
through, in this case, the State of Pennsylvania and into the 
Federal level?
    Ms. Gibbons. We--you are absolutely correct. We--my mother 
passed away of cancer. I would have loved to have this kind of 
pain pill to make her last days better for her. But given the 
fact that it is being abused, and we know it is being abused, 
and this company, as the chairman says, has got $1.2 billion in 
sales. There is things we can do and I think they have to 
contribute to it. And one of those things is to monitor the 
distribution of those pills.
    It is hard for me to track down a meth lab because I don't 
know where the meth lab is. Is it in the Poconos? Is it in 
Upper Bucks County? But I know where this drug is coming from. 
And given the fact that the source of this drug comes from one 
sole source, it should be easy, very easy, to track the 
distribution of that drug. And that requires sharing of 
information among the different organizations, the medical 
profession, the drug company, the pharmacies, having access to 
DEA's information, and, as Christine said, my ability to go 
into a pharmacy and do some kind of audit.
    One of the questions I could not answer when I announced 
the insurance fraud arrest of Paolino and the drug dealing 
arrest, was average citizens can see this. It is common sense. 
A guy came up to me and said, wait a minute. If the guy doesn't 
have a license to practice law--or to practice medicine, I 
mean, how come pharmacies are still filling his prescriptions? 
And how come the insurance companies are still paying his 
claims? And it is a simple matter of fact that we don't share 
information.
    Law enforcement shares information. I worked with every one 
of these law enforcement authorities to arrest both the 
pharmacist and the medical doctor. But the license status of 
this doctor was never shared with the people who were filling 
his prescriptions and the people who were paying his bills.
    And I think if we set up a system, given the fact that we 
know the source of the drug--you know, where is the drug going? 
What doctors are prescribing what amounts? Is that doctor 
properly licensed? You know, is the pharmacy properly 
accounting for its 500 pills or 5,000 pills, or whatever it has 
in its local stores? Law enforcement could have been keyed into 
this particular problem months before we actually were able to 
find out that this doctor and this pharmacy were doing this.
    Mr. Bass. Mr. Demarest, you mentioned in your testimony 
that--if I could paraphrase, that you seem to be able to get 
just about all the information you really need. On the other 
hand, there isn't a conflict, but Ms. Coulter mentioned that 
she didn't have--it wasn't as easy to get--I am not sure--and 
maybe it was Ms. Gibbons that mentioned this. And I am just 
curious to know, do you have access to the records and 
information that you need in order to adequately monitor the 
situation with respect to the abuse of this drug or any other 
prescription drug subject to abuse?
    Mr. Demarest. Congressman, the monitoring system of drugs 
depends from State to State because there is the Federal aspect 
and then there is the State aspect. The Federal aspect is 
covered by ARCOS, which is an electronic computer system that 
is run by DEA. DEA covers the sales of narcotics and other 
Schedule II drugs to pharmaceutical chains from wholesalers, or 
to doctors that are dispensing the drugs.
    In the State of Pennsylvania, we have a system where we are 
able to monitor only Schedule II drugs. That would be--one of 
them which would be Oxycodone or OxyContin. So we would have a 
manual data base with all 3,500 pharmacies in the Commonwealth 
reporting this every month, how many Schedule II prescriptions 
they have. There are over 2 million of those types of 
prescriptions issued a year. And with Pennsylvania senior 
population increasing, we are seeing an increase, too, in 
general narcotic type of prescriptions. So those prescriptions 
are now manually capped.
    Other States monitor both the Schedule IIIs and the 
Schedule IVs. Schedule III is also a problem. That is Vicodin 
or Hydrocodone. That, before OxyContin hit the front page, was 
really a major problem. So that drug in Pennsylvania is not 
monitored by law enforcement. So, to answer your question, we 
should have OxyContin prescriptions monitored. We are now 
developing a computer system that will get that data directly 
from the pharmaceutical chains. But all 3,500 pharmaceutical 
outlets have different technologies and to allow to dump that 
data to the State. But we are making substantial headway.
    Mr. Bass. Ms. Coulter, you stated that the Bureau of 
Narcotics Investigations and Drug Control has the ability to 
inspect and analyze physician records and the pharmacy orders. 
I am wondering if these inspections are routine or are they 
triggered by certain factors? And is it done in such a manner 
as to protect patient privacy?
    Ms. Coulter. Right. See, the local law enforcement does not 
have that right right now. The State does, but local cannot. 
And I just feel that with that right, it would prohibit someone 
who may get involved in corrupt activities from even getting 
involved. If they knew that--there are so many pharmacies. I 
mean, there is one on every other corner in Philadelphia. But 
if they knew that the local law enforcement agents could come 
in and check them, it may just be another check in the system 
to keep them from being involved in that.
    I realize and recognize the patient's rights, and I think 
that is very important. But from--to just look at the scope of 
what is being prescribed, if you have specific pharmacists that 
are not necessarily next to Fox Chase Cancer Center, or 
somewhere where there should be a higher increase, it would be 
nice to know that just to ensure that, you know, we are 
protecting the community that surrounds that area.
    Mr. Bass. Well, I guess, Mr. Chairman, if I could, I have 
just three more questions for Mr. Demarest. You represent the 
Attorney General in the State of Pennsylvania. And it is--is it 
your feeling that Purdue Pharma has taken appropriate action in 
response to increased reports and evidence of growing abuse of 
their product?
    Mr. Demarest. Congressman, I think there are a few things 
that they did well. And one of those was to distribute the 
tamper-proof prescription pads, which I think was well-taken. 
Some States took that measure on their own prior to that 
problem, but Purdue has made that available to other States.
    I guess the real issue comes down to the marketing of the 
actual product. And, as you are aware, there was, for example, 
pens given out comparing dosage qualities--quantities to 
certain other drugs that are a substantially lower schedule. 
One, Propoxyphene or Darvocet, a Schedule IV--the pen that 
Purdue gave out compares it to OxyContin.
    Mr. Bass. What is a pen? Do you mean the thing you----
    Mr. Demarest. Here it is. It is an actual----
    Mr. Bass. Okay.
    Mr. Demarest. Here it is. It would----
    Mr. Bass. All right. It is an advertising--it is 
advertising.
    Mr. Demarest. Can you show him?
    Mr. Bass. Okay.
    Mr. Demarest. I have never--I have only looked at kind of 
photos.
    Mr. Woodworth. It has OxyContin on blue on the side of it. 
It has a little scroll that you pull out and it says how to 
convert patients to OxyContin. And on the flip side it tells 
you the other substances that you can use to do that, including 
Darvocet, which is a Schedule IV, Tylenol with Codeine. And so 
that is the message that we are talking about.
    Mr. Demarest. And that is a concern because the drugs, 
while they are both painkillers, to use a generic term, they 
are different in how they have been ranked, as far as abuse 
potential goes.
    Mr. Bass. Well, are you suggesting that advertising for 
Schedule II drugs be regulated differently?
    Mr. Demarest. I think it----
    Mr. Bass. I mean, that is all that is, is an advertisement. 
Right?
    Mr. Demarest. That is correct. And you still have the 
corresponding duty of the physician when they write that 
prescription for the patient. But, as we know, there is a 
reason why drug companies market, because it impacts on sales.
    Mr. Bass. Sure.
    Mr. Demarest. So there is a symbiotic relationship between 
the marketing the product reaching the streets.
    Mr. Bass. I have no further questions, Mr. Chairman.
    Mr. Greenwood. Thank you. The Chair recognizes himself for 
an additional 10 minutes. I direct a question to you, Mr. 
Meehan. From your experience in Delaware County, can you give 
this committee a sense of the profile of the abusers in your 
county, both those that have died as a result of their abuse, 
and to the extent that you are aware of others who had close 
calls and ended up in the emergency rooms and so forth? I am 
trying to get a sense whether these are hardened long-time drug 
abusers who are shifting from a more expensive drug or a more 
criminalized drug or a hard-to-get drug, and have found 
OxyContin to be just the next phase in their chronic abuse of 
drugs, as opposed to young people. Again, I reference a 
gentleman I spoke with just before the hearing, whose family's 
18-year-old son got in the unfortunate practice of doing pill 
popping with friends not realizing, as the gentleman said to 
me, one drug plus one drug doesn't equal two. And, in this 
case, one plus OxyContin equals ten, in terms of the dangers. 
What can you tell us about the profile of the people you see 
abusing this drug in your county?
    Mr. Meehan. I think that there is a dichotomy and I think 
you have accurately identified it. Among the 26 deaths or the 
25 deaths that we analyzed in the most recent years, 
predominantly we saw people who had a history of drug abuse. 
And, as I indicated before, those who died often died not only 
with Oxycodone as one of the ingredients, but some other kind 
of abused drug as being part of it.
    And I have often focused on the fact that that is an abuser 
population who may have actually found this as an alternative 
to other kinds of abused drugs. And it may, at the outset, be 
something that is an alternative to heroin. For an abuser, it 
has that rush-like quality that is something that is consistent 
with heroin. And, as a result, there is a defined abuser 
population.
    My concern is the extent to which we are generally seeing 
it move beyond the abuser population and into what we call the 
recreational drug area--the rave scene, the club scene. And we 
know it. My detectives are out on the street and they see it. 
And the kids are now carrying it in the clubs. And it is not 
just GHB and Ketamine and Ecstasy. It is now, in addition, 
OxyContin. And the biggest concern we have is the generally 
addictive nature of the drug.
    Mr. Greenwood. Let me turn back to Mr. Woodworth for a 
second, from the DEA. My understanding is that there is a 
private data base, and you help me understand this, that 
records the prescriptions per physician for these Schedule II 
drugs. And that data base--I know that the company will have 
them here shortly. The company has a data base. They know every 
physician in the country that is writing prescriptions for this 
OxyContin and they can--they have a data base that they get 
from--well, I understand it is a private source that--and then 
they can arrange that data to start to show who are the 
physicians that are prescribing the most and rank them.
    To what extent does DEA have access to that kind of 
information?
    Mr. Woodworth. As you mentioned, Mr. Chairman, it is a 
private company, IMS Health. And DEA purchases prescription 
information from this company. And we do so on a fairly regular 
basis from several of their different data bases, the National 
Prescription Audit and the National Therapeutic Index, on a 
fairly regular basis to do that type----
    Mr. Greenwood. And what do you do with--I know here in 
Bucks County we had Dr. Paolino, who is as bad an actor as you 
can find. The guy has gone bankrupt. He has got sexual 
harassment cases going. He has lost his license. He is 
practicing without a license. And he essentially ends up 
selling prescriptions at whatever it was, $69 or $60 a pop to 
walk in the doors. When DEA, when your people came in, he had a 
standing room only office of zombies trying to get their hands 
on the next prescription. Now, does DEA--or should DEA have, 
from this data base, been able to see the Dr. Paolinos of the 
world who were doing 1,200 scripts in, what was it, a month, 
1,200 prescriptions in--over 5 months for this particular 
addictive substance?
    Mr. Woodworth. No, sir. The information in that data base 
is not provided by name, so we would have no idea of the 
physician.
    Mr. Greenwood. So then what does it say? What does this 
information tell you, just the total gross number of 
prescriptions?
    Mr. Woodworth. We rate them--rank them by the number of 
prescriptions per State.
    Mr. Greenwood. Per State.
    Mr. Woodworth. So that is what we would be able to do for 
Pennsylvania, provide the State and local authorities with the 
number of prescriptions.
    Mr. Greenwood. Okay. But that does not come down to the 
physician level.
    Mr. Woodworth. No, sir. Under the Controlled Substances 
Act, that responsibility was specifically relegated to the 
individual States to address the retail level, doctors, and 
pharmacies. That information would be provided not in the 
numeric detail to our State and local counterparts. It would be 
a profile of the trends.
    Mr. Greenwood. Okay. Let me ask, perhaps, a final question 
for Ms. Gibbons. In the 14 overdose cases in Bucks County since 
January of 2000. These are 14 overdose cases with OxyContin.
    Ms. Gibbons. Involving--in each case, there were other 
substances involved.
    Mr. Greenwood. And that is what I want to get a sense of. 
Can you shed a little light on what the profile is in Bucks 
County, if you will, or at least to what extent there were 
other drugs present, alcohol present in the decedent's body?
    Ms. Gibbons. Well, we--I don't know the specifics in terms 
of what the--what was determined at the autopsy. I do know in 
each case it was not just OxyContin. There were other things 
involved. It is difficult to come up with a profile in Bucks 
County. You know, I have been in the DA's office in Bucks for 
18 years. I was not even aware of OxyContin until 2000. And I 
think that the same--the medical examiner would say the same 
thing. So we don't have enough experience to know if this is--
to determine any kind of trends.
    I can say, you know, as Pat did, that we have made arrests 
of sales of OxyContin out of bars. So it will hit the general 
street population and it will hit the recreational user. There 
is no doubt about it. Percocet did. OxyContin will go the same 
way.
    Mr. Greenwood. Maybe I will ask Ms. Coulter the same kind 
of question in terms of--that I have asked Mr. Meehan and now 
Ms. Gibbons. In terms of the profile of the people that you see 
using the drug, in terms of--I think we have heard a consistent 
theme here, that the fear is that this is a drug that may be 
working its way from the hardened, chronic drug abuser who 
finds that the next cheapest, easily accessible, profitable, if 
you will, drug to use, to the kids who are experimenting and 
may find themselves taking the fatal dose, and what they expect 
is just a recreational kind of a lark.
    Mr. Coulter. That is pretty much what we are seeing in 
Philadelphia. We are seeing recreational use within the 15 to 
25-year range. We are seeing it on other levels as well. But it 
is the most disturbing because I really feel that the people 
who are experimenting really feel it is safe because it is a 
pharmaceutical.
    Like when we debrief prisoners or people who are arrested 
for either possession or selling, there isn't that sense that 
it is heroin or it is something that is dangerous, because it 
is made by people who are doctors. It is not a danger, like 
street-level drugs, that you don't know what you are getting in 
the heroin pack. That they really feel they are getting a safe 
product. And the street corner sales are absent all of the 
necessary warnings that are provided when you buy it and use it 
legitimately. And----
    Mr. Greenwood. Do these kids seem to have any concept that 
others who have come before them are dying? In other words, I 
suspect that these 15, 16, 17, and 18-year-old kids are not 
picking up the Philadelphia Inquirer every morning or watching 
the nightly news and following these events. Are they surprised 
to find out how dangerous these drugs are?
    Ms. Coulter. You know, they are not surprised how dangerous 
they are, but I think they are still at that age where they 
really feel they are invincible, that it will only happen to 
somebody else and that this isn't going to happen to me because 
I am not going to take the highest milligram or I am not going 
to mix it with two drugs; perhaps I will only mix it with one. 
But just alcohol alone, or the pill itself, you know, used 
improperly, has that same deadly affect. But it seems very hard 
to reach that age.
    And that is why we have incorporated it into our HEADS-UP 
program where we are starting at the middle school level where 
they don't have that invincible nature yet, that they still 
will learn what it is and what could happen if you did it just 
once. And that is what we are trying to communicate, that a lot 
of our fatalities weren't life-long abusers, that they are 
people who have tried it once or twice, or mixed it with 
another drug or alcohol and it had deadly results.
    Mr. Greenwood. Okay. Thank you. Mr. Bass, any other 
questions at this time?
    Mr. Bass. No, Mr. Chairman. I just wanted to advise, as you 
well know, I am going to have to leave in about an hour. I hope 
that our next Panel of witnesses, because they do represent a 
different part of this whole issue, will be able to give this 
subcommittee a good idea as to exactly what OxyContin is and 
how it compares to Schedule I drugs, which apparently--which 
have no medical use. And what we have gotten into with this 
line of questioning here is really the issue of a Schedule II 
drug which has good medical applicability getting into the 
category, one way or another, of Schedule I. And how these 
people who come about it from a different--not from the law 
enforcement side, propose that, you know, the State and Federal 
authorities deal with the problem. And I yield back.
    Mr. Greenwood. Let me just offer that the panelists, if 
there is any of you who feel that there is a point that you 
haven't made that you want to get across, something that this 
committee should know--have we asked you all the right 
questions? Are there other comments or statements you felt you 
need to--to help us put on the record?
    Ms. Gibbons. I just want--I would like to make one 
statement because this is in Bucks County, and I know it is 
going to hit my media and I am worried about this. I understand 
that most of the deaths occurred because they were in 
combination with other drugs. But I don't want the message to 
go out to other kids that, you know, the kids--hey, I can take 
it as long as I don't take it with something else. I am going 
to be safe. Because that is not the case. They could die with 
the pill alone. They could die with alcohol. And while our 
experience has been other drugs were involved, I don't want to 
send the message that if other drugs aren't involved, they are 
okay.
    Mr. Greenwood. And that is an excellent point, and I thank 
you for making it. And I thank each of the witnesses for being 
with us today and for your testimony and you are now excused. 
Thank you.
    We will now call forward our next panel of witnesses. And 
they are Michael Friedman, Executive Vice President and Chief 
Operating Officer of Purdue Pharma.
    Okay. If we can resume order here. Our next panel consists 
of Michael Friedman, Executive Vice President and Chief 
Operating Officer of Purdue Pharma. We would call him forward. 
As well as Michael Levy, Dr. Michael Levy, M.D., and Ph.D, Vice 
Chairman of Medical Oncology, Director of Supportive Oncology, 
and Director of the Pain Management Center at the Fox Chase 
Cancer Center; Terry Atwood, Registered Nurse; and Dr. John 
Jenkins, Director of the Office of Drug Evaluation, The Center 
for Drug Evaluation and Research Food and Drug Administration.
    And I would ask the audience to please take your seats 
again and desist from conversations, please, so that we can 
have the attention of our witnesses. Thank you, each of you, 
for being with us. You are aware that this committee is holding 
an investigative hearing. And when we do so, we have had the 
practice of taking testimony under oath. Do any of you have 
objections to testifying under oath? Seeing no objections, the 
Chair then advises you that under the rules of the House and 
the rules of the committee, you are entitled to be advised by 
counsel. Do you desire to be advised by counsel during your 
testimony today?
    Mr. Friedman. Yes, Mr. Chairman. I am advised by Mr. Howard 
Udell and Dr. Paul Goldenheim. It is my intention to defer to 
my colleagues when you or the Congressman Bass have questions 
relating to their areas of responsibility.
    Mr. Greenwood. In that case, when I swear the witnesses in, 
your counsel who will be advising you will be asked to take the 
oath as well.
    Mr. Friedman. Thank you, Mr. Chairman.
    Mr. Greenwood. Anyone else who wished to be advised by 
counsel? All right. In that case, if you would please rise and 
raise your right hand, I will swear you in, and that includes 
any counsel who will be advising.
    [Witnesses sworn.]
    Mr. Greenwood. Okay. In that case, you are under oath. And 
ask you to please be seated. And we will begin by calling 
Michael Friedman from Purdue Pharma for his testimony.

TESTIMONY OF MICHAEL FRIEDMAN, EXECUTIVE VICE PRESIDENT, CHIEF 
 OPERATING OFFICER, PURDUE PHARMA, L.P., ACCOMPANIED BY HOWARD 
 UDELL, EXECUTIVE VICE PRESIDENT AND GENERAL COUNSEL, AND PAUL 
D. GOLDENHEIM, SENIOR PHYSICIAN; MICHAEL H. LEVY, VICE CHAIRMAN 
 MEDICAL ONCOLOGY, DIRECTOR OF SUPPORTIVE ONCOLOGY, DIRECTOR, 
   PAIN MANAGEMENT CENTER, FOX CHASE CANCER CENTER; THERESA 
 ATWOOD; JOHN JENKINS, DIRECTOR, OFFICE OF DRUG EVALUATION II, 
    CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG 
                         ADMINISTRATION

    Mr. Friedman. Thank you, Mr. Chairman. My name is Michael 
Friedman and I am the Executive Vice President and the Chief 
Operating Officer of Purdue Pharma, the distributor of 
OxyContin tablets and other medications. My responsibilities at 
Purdue include the direct oversight and management of sales, 
marketing, human resources, licensing, and business 
development.
    With me today, and available to answer the committee's 
questions, are Mr. Howard R. Udell, our Executive Vice 
President and General Counsel, and Dr. Paul D. Goldenheim, the 
Senior Physician at Purdue. Dr. Goldenheim is responsible for 
all research, development, and both regulatory and medical 
affairs at our company. Mr. Udell has the primary 
responsibility for the company's U.S. legal affairs.
    Before I begin my brief remarks, I ask to place on the 
record my entire opening statement for the hearing record, 
along with two accompanying annexes to my remarks, which are in 
the committee's possession and available at this hearing.
    Mr. Greenwood. Without objection, those documents will be 
entered into the formal record.
    Mr. Friedman. Thank you, Mr. Chairman. On behalf of Purdue 
Pharma, L.P., the distributor of OxyContin tablets, thank you 
for taking the time to hold this hearing. We are more 
distressed than anyone at this hearing that our product, which 
is providing so much relief to so many people, is being abused. 
The availability of OxyContin is critical for millions of 
patients who are suffering from moderate to severe pain where a 
continuous around-the-clock analgesic is needed for an extended 
period of time.
    Unfortunately for those patients, concern generated by the 
abuse of OxyContin has mushroomed to the point that in some 
locations, some patients are asking their doctors to switch 
them to less effective medicines, some doctors are refusing to 
renew patients' prescriptions for OxyContin, and some 
pharmacists are no longer willing to carry OxyContin for their 
patients. Purdue receives alarming reports every day from such 
physicians and patients. For these patients in pain, this 
hearing is timely and important.
    Today's hearing should focus on a significant question of 
public health policy--how to address the problems of abuse and 
diversion which accompany the sale of controlled prescription 
drugs like OxyContin without restricting its availability to 
meet the needs of doctors and patients for the effective 
management of pain? This question is neither new nor unique to 
OxyContin. It has existed as long as opioid analgesics have 
been available. It is a critical question, and we are confident 
that Purdue has devoted more resources and efforts than any 
pharmaceutical company in attempting to answer this question. 
Purdue has provided, and continues to provide, extensive 
assistance to the law enforcement communities and medical 
communities in preventing and policing the abuse of OxyContin.
    While all of the voices in this debate are important, we 
must be especially careful to listen to the voices of patients 
who, without drugs like OxyContin, would be left suffering from 
their untreated or inadequately treated pain. Purdue frequently 
hears stories of how OxyContin has enabled people to return to 
their families and to productive lives after suffering 
disabling pain. We urge you to hear directly from some of these 
patients at future meetings. They are not addicts. They are not 
criminals. They are people who, because of cancer, sickle cell 
anemia, severe back injuries, or some other physical insult or 
disease, have had their lives taken away from them by 
unrelenting pain.
    Amidst all the publicity and controversy, a few facts do 
stand out. First, the problem of chronic pain in this country 
is enormous and it is expensive. According to organizations 
like the American Pain Foundation, an estimated 50 million 
Americans suffer from chronic pain, with a cost approximating 
$100 billion attributable to lost workdays, excessive or 
unnecessary hospitalizations, unnecessary surgical procedures, 
inappropriate medication, and patient-incurred expenses from 
self-treatment. Even more important than all of this, is that 
these are people in pain who are suffering.
    Second, chronic pain has been historically undertreated. In 
this decade, for the first time, public and medical opinion has 
swung decisively in favor of active treatment of pain, in part, 
based on the proven effectiveness of opioid therapy in treating 
pain and the startling improvement in quality of life such 
therapy can offer to patients.
    In 1994, the Department of Health and Human Services issued 
new guidelines encouraging the use of opioids in the treatment 
of cancer pain. In February 1999, the Veterans Administration 
added pain as a fifth vital sign, along with pulse, 
temperature, respiration, and blood pressure, that should be 
checked regularly as major indicators of health.
    Congress, itself, has aggressively worked to help the cause 
of recognizing pain as a vital part of modern medical 
treatment. On October 28, 2000, Public Law 106-386 was enacted 
declaring the decade commencing on January 1, 2001, to be the 
Decade of Pain Control and Research. Bills currently pending in 
both the House and Senate, The Conquering Pain Act of 2001, S. 
1024, and H.R. 2156, recognize that chronic pain is a chronic 
health problem affecting at least 50 million Americans. These 
legislative initiatives seek long-lasting changes in public 
health policy that would enable all Americans to effectively 
manage medical conditions associated with chronic pain.
    Mr. Chairman, we thank you for your co-sponsorship of both 
H.R. 149 and H.R. 2188. Both bills advanced the cause of 
effective pain management.
    Third, OxyContin is widely recognized as a highly effective 
treatment for pain. Its 12-hour controlled-release mechanism 
affords and extended dose of pain medication, allowing patients 
to sleep through the night and to avoid the sharp spikes in 
blood levels of medicine that can cause side effects. Even the 
most vocal critics of opioid therapy concede the value of 
OxyContin in the legitimate treatment of pain. And many 
patients tell their doctors and Purdue that OxyContin has given 
them back their lives. Purdue is furnishing for the record 
several documents that it has received from patients and their 
families describing the importance of OxyContin in managing 
their pain, along with a paper prepared by Pinney Associates, 
Incorporated, that describes OxyContin's importance to public 
health.
    My company shares this committee's commitment to fighting 
abuse and diversion of controlled medicines. Abuse and 
diversion harm patients with pain. They harm the abusers. They 
harm the cause of pain management. They harm our products and 
they harm us. Importantly, abuse and diversion threaten sound 
health policy, whose course should be driven by the health 
needs of millions of patients, and not the crimes of diverters.
    Mr. Chairman, thank you for the time you have set aside 
today to discuss abuse and diversion of our product. My 
colleagues and I will be happy to answer any questions.
    [The prepared statement of Michael Friedman follows:]
Prepared Statement of Michael Friedman, Executive Vice President, Chief 
                 Operating Officer, Purdue Pharma L.P.
    Mr. Chairman: On behalf of Purdue Pharma L.P., the distributor of 
OxyContin' tablets, thank you for taking the time to hold 
this hearing. We are more distressed than anyone that this drug, which 
is providing so much relief to so many people, is being abused. The 
availability of OxyContin' is critical for countless 
patients who are suffering from moderate to severe pain where a 
continuous around-the-clock analgesic is needed for an extended period 
of time. Unfortunately for those patients, concern generated by the 
abuse of OxyContin' has mushroomed to the point of hysteria 
in some locations, with the result that some patients are asking their 
doctors to switch them to less effective drugs, some doctors are 
refusing to renew patients' prescriptions for OxyContin' and 
some pharmacies are no longer willing to carry OxyContin' 
for their patients. Purdue receives alarming reports every day from 
such physicians and patients. This hearing is important and timely.
    Today's testimony bears on a significant question of health policy: 
how to address the problems of abuse and diversion which accompany the 
sale of a controlled drug like OxyContin' without 
restricting its availability to meet the needs of doctors and patients 
for the effective management of pain? This question is neither new nor 
unique to OxyContin'. It has existed as long as opioid 
analgesics have been available. It is a critical question, and we are 
confident that Purdue has devoted more resources and efforts than has 
any pharmaceutical company in attempting to answer that question. 
Purdue has provided, and continues to provide, extensive assistance to 
the medical and law enforcement communities in preventing and policing 
abuse of OxyContin'.
    While all of the voices in this debate are important, we must be 
especially careful to listen to the patients who, without drugs like 
OxyContin', would be left untreated. Purdue frequently hears 
stories of how OxyContin' has enabled people to return to 
their families and to productive lives after suffering disabling pain. 
We urge you to hear directly from some of these patients at future 
hearings. They are not addicts. They are not criminals. They are people 
who, because of cancer, sickle cell anemia, severe back injuries, or 
some other physical insult, have had their lives taken away from them 
by unrelenting pain.
    Amidst all the publicity and controversy, a few facts stand out.
     First, the problem of chronic pain in this country is 
enormous and expensive. According to organizations like the American 
Pain Foundation, an estimated 50 million Americans suffer from chronic 
pain, with a cost approximating $100 billion a year attributable to 
lost workdays, excessive or unnecessary hospitalizations, unnecessary 
surgical procedures, inappropriate medication and patient-incurred 
expenses from self-treatment.
     Second, chronic pain has been historically undertreated. 
In this past decade, for the first time, public and medical opinion has 
swung decisively in the other direction, based on the proven 
effectiveness of opioid therapy in treating pain and the startling 
improvement in quality of life such therapy can offer to patients.

--In 1994, the Department of Health and Human Services issued new 
        guidelines encouraging the use of opioids in the treatment of 
        cancer pain.
--In February of 1999, the Veterans Administration added pain as a 
        fifth vital sign (along with pulse, temperature, respiration, 
        and blood pressure) that should be checked regularly as major 
        indicators of health.
          ``VA officials said the change in routine is designed to call 
        physicians' attention to what is widely considered one of the 
        most unrecognized and untreated symptoms in American health 
        care. In a study of 10,000 dying patients published in 1995 in 
        the Journal of the American Medical Association, for instance, 
        researchers found that almost half died in severe pain; other 
        studies report that as many as three-quarters of advanced 
        cancer patients are in pain.''
                                  Washington Post, February 1, 1999
    Many other healthcare professionals and organizations have adopted 
        this practice of checking pain as a fifth vital sign.
--On October 28, 2000, Public Law 106-386 was enacted declaring the 
        decade commencing on January 1, 2001 to be the ``Decade of Pain 
        Control and Research.'' Bills currently pending in both the 
        House and Senate (The Conquering Pain Act of 2001, S. 1024 and 
        H.R. 2156) recognize that ``chronic pain is a chronic health 
        problem affecting at least 50,000,000 Americans,'' and seek 
        long-lasting changes that would enable all Americans to 
        effectively manage medical conditions associated with chronic 
        pain.
     Third, OxyContin' is widely recognized as a 
highly effective treatment for pain. Its twelve-hour controlled-release 
mechanism affords an extended dose of pain medication, allowing 
patients to sleep through the night and to avoid sharp spikes in blood 
levels of the medicine that can cause side effects. Even the most vocal 
critics of opioid therapy concede the value of OxyContin' in 
the legitimate treatment of pain. And many patients tell their doctors 
and Purdue that OxyContin' has given them back their lives. 
Purdue is furnishing for the Record several documents that it has 
received from patients and their families describing the importance of 
OxyContin' in managing their pain, along with a paper 
prepared by Pinney Associates, Inc. that describes 
OxyContin's' importance to public health.
    Purdue shares this Committee's commitment to fighting abuse and 
diversion of controlled medicines. Abuse and diversion harm patients 
with pain. They harm the abusers. They harm the cause of pain 
management, and they harm Purdue and its products. Importantly, abuse 
and diversion threaten sound health policy, whose course should be 
driven by the health needs of millions of patients, not the crimes of 
diverters.
                     1. the company: purdue pharma.
    Purdue Pharma is a privately held pharmaceutical company, founded 
by physicians. Purdue's headquarters are in Stamford, Connecticut. 
OxyContin' is manufactured at facilities in Totowa, New 
Jersey and Wilson, North Carolina.
    Family ownership of Purdue and its associated companies began with 
the purchase of The Purdue Frederick Company in 1952. In those early 
days, Purdue's main products were Betadine' antiseptics and 
Senokot' laxatives. Since the early 1980s, Purdue has 
focused its research and development efforts primarily on medications 
for pain management. One of the most significant advances introduced by 
Purdue is the use of controlled-release opioid analgesics for the 
treatment of moderate to severe pain. Controlled-release opioid 
analgesics, pain medicines which last for 12 hours or more, enable 
patients to sleep through the night and reduce the cycles of dosing 
which provide better control of pain than drugs that require dosing 
every 4 to 6 hours. Purdue introduced MS-Contin' tablets, a 
controlled-release form of morphine, in 1984, and a controlled-release 
oxycodone product, OxyContin' tablets, in January 1996.
    Since 1984, Purdue has worked diligently to inform doctors and 
other healthcare professionals about appropriate use of opioid based 
medicines. This has required a significant investment, as medical 
schools have traditionally spent little time teaching doctors how to 
assess and treat pain or how to use our best medicines for moderate to 
severe pain. For example, when Purdue started selling opioid analgesics 
in 1984, many doctors were not aware that morphine could be given 
orally as a treatment for pain. Today, administration of oral 
controlled-release morphine is considered standard practice for the 
treatment of cancer pain.
    Purdue has extensively studied the use of these drugs in the 
treatment of moderate to severe pain associated with various non-
malignant diseases. Often, this type of pain will only respond 
adequately to opioid analgesics. Without opioid therapy, many of these 
patients suffer and are disabled. Purdue's clinical research has 
provided valuable experience and data to guide physicians in properly 
using these medicines; for example, on determining the proper dose and 
dealing with side effects.
             2. the product: oxycontin' tablets.
    No legal drug in the United States is more rigorously regulated 
than OxyContin'. It is a Schedule II drug under the federal 
Controlled Substances Act. OxyContin' is monitored by state 
and federal health officials in its production, marketing, and 
distribution. Both the FDA and DEA oversee OxyContin'.
    The sole active ingredient in OxyContin' is oxycodone, a 
synthetic opioid (narcotic) first developed in 1916. Oxycodone has been 
sold in various forms in the United States for over 60 years. 
Percodan', Percocet', and Tylox' are 
examples of oxycodone products. Typically, but not always, these forms 
of oxycodone have been combined with a co-analgesic agent such as 
aspirin or acetaminophen, and they are referred to as ``combination 
analgesic products''. In large doses those non-opioid analgesics may be 
toxic to the liver, stomach and kidneys. Therefore, drugs containing 
either aspirin or acetaminophen are limited in their usefulness because 
a patient can only take up to a set amount per day to avoid aspirin or 
acetaminophen toxicity. Even if a patient needs more pain relief, the 
maximum dose of a combination analgesic cannot be exceeded. Purdue's 
contribution was to introduce oxycodone in a timed controlled-release 
form without any other active ingredients that could impose limits on 
the amount a patient could take in a day.
    Because of the efficacy of this single entity, controlled-released 
product, doctors have found OxyContin' extremely effective 
in properly managed programs of pain treatment. That effectiveness--not 
abuse and diversion--led to the commercial success of the product.
 3. purdue's promotion and marketing of oxycontin' tablets.
    Certain media reports have been critical of Purdue's promotion of 
OxyContin' tablets. The criticisms have ranged from Purdue's 
provision of pain management training to doctors to the individual 
promotion of OxyContin' by Purdue's sales representatives. 
These reports are unfair to Purdue and squarely at odds with the facts.
    Purdue's marketing efforts for OxyContin' have been 
conservative by any standard. OxyContin' tablets are not 
promoted to consumers. The few advertisements that appear are solely in 
medical journals. Purdue is scrupulous in training its field sales 
force to promote OxyContin' only for its approved 
indications. Purdue managers monitor its field force for compliance 
with these policies. Sales representatives are told that in the event 
of a violation of our marketing policies, the offender will be subject 
to discipline, up to and including termination.
    Purdue does not believe that aggressive marketing played any role 
whatsoever in the abuse and diversion of OxyContin'. The 
physicians who were victims of ``doctor-shopping'' or prescription 
fraud were hardly in this position because of our marketing. The 
physicians who have been convicted of improperly prescribing 
OxyContin' in exchange for cash or other inducements were 
hardly motivated to do so by our marketing. And robberies from patients 
with proper prescriptions were hardly encouraged by our marketing. To 
the contrary, our marketing has encouraged physicians to take actions 
that would reduce the abuse and diversion of OxyContin'. 
Purdue has asked physicians to carefully:

--Prescribe only the quantity of product that the physician deems is 
        necessary based upon a complete history and physical 
        examination and careful assessment of the patient's pain,
--Determine that the nature and severity of the patient's pain requires 
        an opioid analgesic for an extended duration,
--Prescribe a quantity of medicine based upon the dosage that the 
        patient requires, and
--Follow up carefully with each and every patient on a regular basis.
(a) Purdue's training of its sales representatives.
    Virtually all of Purdue's field force is recruited from within the 
pharmaceutical industry. New sales representatives, despite their prior 
experience, are enrolled in a 26 week training program, which includes 
three weeks of class room training at the home office. Sales 
representatives are given extensive training in the principles of 
proper promotion of pharmaceutical products. They are directed to 
promote only those uses of our products which are approved by the FDA 
and to use only those promotional materials which are approved for use 
after rigorous medical, regulatory and legal review. During this 
training, representatives are told that our standard of conduct is that 
during every sales call they should act as if they were accompanied by 
an FDA inspector. Upon returning from their home office training, new 
representatives are closely monitored by their managers who will spend 
time in the field visiting doctors with them. In addition, field 
trainers from the local area and the home office will often ride with 
new representatives.
    Moreover, in July, 2001, Purdue established a telephone ``hot 
line'' to receive comments from any physician who believes a Purdue 
sales representative has in any way promoted our products in an 
inappropriate manner. Purdue knows of no other pharmaceutical company 
that has gone to such lengths to insure that on a day-to-day basis its 
sales representatives comply with the high standards that are 
established during their training. The results have been reassuring; 
rather than being critical, the vast majority of calls to the hot line 
have complimented the professionalism of our sales representatives.
(b) Physician Education.
    There is widespread consensus that medical practitioners, in the 
course of their medical education, have received limited and often 
inadequate training in the management of chronic pain. Physician 
education has always been a principal feature of Purdue's marketing and 
medical education efforts. As early as 1984 we saw that physicians 
wanted and needed more information about how to assess pain in their 
patients, how to determine the right dose of pain medicine, how to 
treat side effects, and more recently, how to deal with the risks of 
abuse and diversion. At the outset we realized that this task called 
for a highly professional and highly trained field force supported by 
an extensive medical education effort.
    Purdue sponsors extensive training for the medical professional 
community. Specifically, Purdue sponsors local lectures at hospitals 
and other institutions as part of Purdue's lecture programs. These 
lectures are typically attended by 40 or 50 physicians or other 
healthcare professionals and deal with topics of interest to physicians 
such as pain assessment, dosing, abuse and diversion, managing pain 
caused by different diseases, and side effects. The lectures are often 
given by experts and opinion leaders in the field of pain treatment. 
They are held locally and Purdue does not pay physicians attending 
these meetings for their participation.
    Purdue also sponsors symposia and lectures at larger medical 
meetings that are hosted by others. Purdue does not pay physicians 
attending these meetings for their participation.
    Until a year ago, Purdue also sponsored programs to train 
experienced doctors and other healthcare professionals to serve as 
lecturers to instruct other health care professionals in pain 
management. These are the only trips for which Purdue provided expenses 
for the travel and accommodations of physicians. It would have been 
impractical to provide such training individually to participating 
doctors in their home cities rather than in one central location. These 
meetings were intensive working sessions that focused on issues of pain 
management, and also trained and evaluated the participants in 
effective speaking and communication skills.
                 4. what is the nature of the problem?
    OxyContin' is an opioid analgesic used to treat pain. 
Each tablet of OxyContin' delivers to the patient over a 
period of twelve hours, a controlled-release of oxycodone. Like 
morphine, OxyContin' is a Schedule II drug with recognized 
abuse potential. From inception, the package insert and all promotional 
material for OxyContin' has cautioned:
        ``TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN, 
        CHEWED OR CRUSHED. TAKING BROKEN, CHEWED OR CRUSHED OxyContin 
        TABLETS COULD LEAD TO THE RAPID RELEASE AND ABSORPTION OF A 
        POTENTIALLY TOXIC DOSE OF OXYCODONE.''
    Since early in the year 2000 there have been a number of reports of 
OxyContin' tablets being diverted and abused by drug 
abusers. The patterns of abuse involve crushing the tablets to obtain 
immediately the full dose of oxycodone and then ingesting, snorting or 
injecting the drug. In a number of cases, there have been overdoses and 
deaths. Virtually all of these reports involve people who are abusing 
the medication, not patients with legitimate medical needs under the 
treatment of a healthcare professional. Further, the vast majority of 
those deaths involve the use of multiple medications--not oxycodone 
alone.
        5. what is the source of diverted oxycontin'?
    According to law enforcement experts, OxyContin' and 
other legitimate prescription drugs find their way into illicit 
channels by means of prescription fraud, ``doctor shopping'' or other 
methods of receiving inappropriate prescriptions from a doctor, theft, 
diversion from Mexico, and Internet pharmacies. You have seen stories 
in your local newspapers describing some of these practices.
    Unfortunately, Purdue recently had an incident that we are 
aggressively addressing. Purdue manufactures OxyContin tablets in two 
locations. These factories operate under FDA guidelines for Good 
Manufacturing Practices and are routinely inspected by the Food and 
Drug Administration and the Drug Enforcement Administration. Despite a 
17 year history of manufacturing controlled substances without an 
incident of theft, last month Purdue discovered that two company 
employees had stolen OxyContin' tablets from the production 
line at its Totowa, New Jersey plant. Company officials immediately 
notified local police and the DEA and terminated the employment of 
these individuals, who were taken into custody by the police. Purdue as 
well as the local police, DEA, and FDA are conducting further 
investigations and Purdue is committed to full cooperation with these 
law enforcement agencies. All internal security procedures are being 
analyzed, and any weaknesses will be addressed. At this point in the 
investigations, we feel it would be inappropriate to comment further.
                   6. how widespread is the problem?
    Both Purdue and law enforcement are trying to understand the extent 
of this problem. Initially, the abuse of OxyContin' tablets 
was concentrated in a few parts of a few states, generally along the 
spine of Appalachia, where abuse of other prescription drugs has long 
been a problem due to many factors, including poverty and lack of 
opportunity. In those areas the problem of the abuse of 
OxyContin' is serious. The geographic scope is now broader. 
Regrettably, widespread media attention may have contributed to this 
wider geographic scope by calling to the attention of potential abusers 
in all parts of the country that OxyContin' is a desirable 
drug of abuse, along with providing detailed instructions on how to 
obtain the drug and how to abuse it.
    Nevertheless, it remains difficult to obtain hard evidence on the 
extent of OxyContin' abuse. For example, media accounts 
regularly attribute large numbers of overdose deaths to 
OxyContin', even though the only toxicological evidence is 
that the decedent has oxycodone in his/her blood. OxyContin' 
is but one of many available products that contain oxycodone. Indeed, 
OxyContin' tablets accounted for only 25% of the 
prescriptions written for oxycodone products in this country in the 
year 2000. Some toxicological screens of these decedents also detect 
the presence of acetaminophen or aspirin, a signal that some other form 
of oxycodone may have been ingested. In the vast majority of these so 
called ``OxyContin deaths'', toxicological screens reflect ingestion of 
a ``cocktail'' of legal and illegal drugs, and frequently alcohol as 
well, in the blood of the decedent. In these cases, death is usually 
attributed to the abuse of multiple drugs.
    While even one death associated with the abuse of 
OxyContin' is tragic, based on our preliminary analysis of 
the data, it appears that the media has significantly misreported the 
problem. This is most clearly shown by referring to the numbers of 
deaths the press has attributed to the abuse of OxyContin' 
Tablets. A few representative examples follow:

--The press indicated that Blair County, Pennsylvania was an area of 
        high OxyContin' abuse and that a large number of 
        people had died as a result. However, the County Coroner 
        reported to us that there were 58 deaths in the county from 
        January 1996 through December of 2000 and that none of them 
        were attributed to oxycodone alone. Of the 58 deaths, 50 
        involved multiple drugs. Oxycodone (although not necessarily 
        OxyContin') was one of the drugs found in only seven 
        cases, and was not listed as the cause of death in any case.
--The press has reported and repeated over two hundred times that in 
        Kentucky, OxyContin' caused the deaths of 59 people. 
        Our contacts with the State Medical Examiner and local coroners 
        establish that a number of deaths resulted from combinations of 
        illegal and legal drugs, which occasionally included oxycodone, 
        the active ingredient in OxyContin'. Thus far, these 
        local authorities have not asserted that a single death was 
        attributable to the abuse of OxyContin' alone.
--The press reported 35 deaths from OxyContin' use in Maine. 
        Similar information from the Office of the Chief Medical 
        Examiner showed that there were two cases where abuse of 
        OxyContin' was the sole cause of death, one of these 
        a suicide.
    These statistics are provided not to minimize the tragedy of even a 
single loss of life, but as examples of how the media coverage has made 
it difficult to obtain an understanding of what is actually occurring. 
We are gathering the facts as noted from local medical examiners and 
coroners. In addition, according to the most recently available annual 
data published by the US Government's Drug Abuse Warning Network 
(DAWN), oxycodone in all forms, including OxyContin', was 
mentioned in fewer than 1% of all prescription drug-related Emergency 
Room visits in which abuse was suspected. This compares with 8.7% for 
marijuana, 1.7% for hydrocodone (another opioid analgesic), and 3% for 
acetaminophen.
               7. could purdue have foreseen the problem?
    In some 17 years of marketing MS-Contin' Tablets, a 
controlled-release form of morphine--a powerful opioid analgesic 
related to oxycodone--Purdue was aware of no unusual experience of 
abuse or diversion. Purdue had no reason to expect otherwise with 
OxyContin.' As late as January of 2000, US Attorneys Jay 
McCloskey of Maine and Joe Famularo of Kentucky were advised by the DEA 
that abuse of OxyContin' did not appear to be a national 
problem. It was early in April of 2000 that Purdue was first alerted to 
reports of abuse and diversion of OxyContin' by accounts in 
Maine newspapers claiming that OxyContin' was the subject of 
recreational use in Maine. Purdue immediately implemented a response 
team that included some of the Company's top executives and scientists, 
including those who are here today. That team has committed Purdue to 
an unprecedented program to combat abuse and diversion.
             8. what is purdue doing about this situation?
    A long term solution to the problem of prescription drug abuse 
includes the development of medicines that are inherently resistant to 
such abuse. Purdue actually has been working to develop such opioid 
medicines since 1996, but had originally targeted oral abuse, not 
injection. In 1997, Purdue met with representatives of the DEA, NIDA, 
and FDA to discuss this subject and seek information and advice. At 
that meeting, Purdue presented a plan to develop a medicine containing 
hydrocodone and an agent to prevent abuse by injection. Purdue was 
told, however, that the principal method of abuse of hydrocodone was by 
mouth, and not injection. As a result of this advice, Purdue launched 
an effort to develop medicines that would be resistant to oral abuse. 
This was and is a formidable undertaking as there was no existing 
proven technology to achieve this goal. As a result of this effort, 
Purdue developed several technologies that should enable us to achieve 
the goal of having an opioid medicine that is resistant to abuse by the 
oral route as well as by injection. This was recently announced in the 
press.
    The majority of law enforcement officials who have commented have 
lauded Purdue's initiatives described below. The Attorney General of 
Virginia said that as soon as Purdue learned of the problem, ``it 
jumped in with both feet'' to solve it. The Attorney General of 
Maryland praised Purdue's efforts and proposals and expressed concern 
that adverse publicity might make it more difficult for patients in 
need to obtain the product. Several United States Attorneys have 
complimented Purdue for its cooperation and have requested that Purdue 
bring its anti-abuse and diversion programs to their region. In several 
cases the United States Attorney or his assistant has actually appeared 
on such programs.
    Purdue's efforts to solve the problem have included the following:

--Purdue approached and worked with FDA on labeling changes to 
        emphasize the abuse potential of OxyContin'. Those 
        changes were effected on July 18, 2001. FDA has called for 
        other drug companies to follow Purdue's lead in making such 
        changes.
--To reduce the incidence of diversion caused by physician prescribing 
        errors or ``scams'', Purdue has supported continuing medical 
        education programs of the highest quality in the areas of abuse 
        and diversion. These are non-promotional programs which teach 
        doctors how to avoid being ``scammed'' by abusers, how to 
        properly assess and treat patients with real pain and how to 
        prevent diversion.
--To encourage physicians and pharmacists to take measures to prevent 
        abuse and diversion, Purdue has communicated extensively on 
        this subject with healthcare professionals. Abuse and diversion 
        brochures, developed in cooperation with law enforcement 
        authorities, have been distributed to over 500,000 doctors and 
        pharmacists. These brochures have been praised by law 
        enforcement and welcomed by healthcare providers.
--To encourage physicians to properly assess pain and monitor the use 
        of these drugs in patients with pain, and avoid inappropriate 
        prescribing or being misled by diverters, Purdue has 
        distributed ``opioid documentation kits'' for years.
--To reduce the fraud that is generated by diverters altering or 
        copying prescriptions, in 16 states, Purdue has provided at no 
        cost to physicians, prescription pads utilizing special 
        technologies that make such alteration and copying extremely 
        difficult. 4667 physicians had ordered these pads as of August 
        17, 2001.
--To stop diversion that results from doctor shopping, Purdue has 
        supported the implementation of Prescription Monitoring 
        programs and federal government incentives to states to 
        encourage them to implement such programs to a federal standard 
        that insures accurate gathering of data, together with limited 
        access to the databases only by authorized law enforcement 
        officials and health care professional. We understand that 
        these programs, which would provide physicians and pharmacists 
        with a resource they could utilize to check up on questionable 
        patients, have been highly useful to physicians and law 
        enforcement authorities in those states where they have been 
        implemented to a high standard.
--Purdue has taken strong measures to prevent diversion of its product 
        from Mexico. We believe that these steps are unprecedented in 
        the pharmaceutical industry. Purdue has stopped shipping the 40 
        mg strength to Mexico and changed the markings on the 20 mg and 
        10 mg tablets sold in Mexico, so that law enforcement will be 
        in a position to identify tablets that are brought in from 
        Mexico. In addition, Purdue has made arrangements so that 
        OxyContin' sold in Mexico will have limited 
        distribution only through pharmacies that handle the most 
        restricted category of opioid analgesics available in Mexico.
--To better our understanding of the problem, and to participate in 
        solutions, some of the most senior executives from Purdue have 
        traveled to states where abuse and diversion have been reported 
        to hold briefing meetings with law enforcement officials, 
        including U.S. Attorneys and Attorneys General. We have also 
        met with the DEA, FDA and NIDA.
--Due to a paucity of reliable data on the nature and extent of the 
        problem of prescription drug abuse, Purdue has been working 
        with government and independently to develop hard data. Purdue 
        has assembled a team of experts to guide us in the development 
        of a system that will enable us to monitor abuse and diversion 
        and allow constructive intervention, when possible.
--As discussed above, Purdue is spending tens of millions of dollars to 
        research and develop new forms of strong pain relievers which 
        would be resistant to abuse while at the same time provide safe 
        and effective pain relief to legitimate patients. We are 
        working with the FDA to accelerate the availability of these 
        drugs.
    9. is restricting the use of oxycontin' the solution?
    Some have suggested that restricting availability of 
OxyContin' will help alleviate the problem. We are convinced 
this is not so. Those intimately involved with the problem agree. Local 
law enforcement officers have told us that in most of the reported 
cases of overdose and death, OxyContin' was neither the 
first nor the sole drug abused. Knowledgeable law enforcement officers 
have said that if OxyContin' were not available, those 
abusing and diverting drugs would not stop their practices, but would 
simply transfer to other legal and illegal drugs. We are advised by law 
enforcement that in at least one area where effective measures have 
reduced the availability of OxyContin', abusers and 
diverters have in fact returned to their prior drugs of abuse. The only 
real impact of restricting the availability of OxyContin' 
tablets would be to make it more difficult for the patients who benefit 
from this drug to obtain it.
                       10. what is the solution?
    Solving the problem of drug abuse requires the cooperation of many 
elements in our community: law enforcement, the schools, religious 
institutions, parents and family, the courts, the medical community, 
the press, federal and state legislators, government agencies, social 
services providers, and the pharmaceutical industry. Purdue is trying 
to help through our specific programs and our cooperation with the 
other elements in the community. Prescription Monitoring Programs can 
reduce doctor shopping and diversion from medical practices. Tamper 
resistant prescriptions can reduce copying or alteration. Education of 
responsible doctors can arm them with the tools they need to stop 
diversion from their practices. A better information system can allow 
us to know where abuse and diversion is cropping up and allow medical 
education and law enforcement to act earlier to ``nip these problems in 
the bud.'' Development of abuse resistant products can reduce the 
incidence of abuse. What is needed is cooperation and common purpose. 
This is a long-standing societal problem that requires a reasoned 
solution.
                            11. conclusion.
    The management of chronic pain is a critical priority of healthcare 
in this country. Chronic pain affects as many as 50 million Americans 
and costs the country $100 billion annually. OxyContin' has 
proven itself an effective weapon in the fight against pain, returning 
many patients to their families, to their work, and to their ability to 
enjoy life. That advance should not be stunted or reversed because of 
the illegal activities of those who divert and abuse the drug. The 
answer to these problems is increased education, information and 
enforcement, not restrictions that will deny patients effective 
treatment of their pain.

    Mr. Greenwood. Thank you very much for your testimony. We 
will now hear from Dr. Michael--I have been saying Levy and 
Levy. Which is it?
    Mr. Levy. Levy.
    Mr. Greenwood. Levy. Dr. Michael Levy, Vice Chairman of 
Medical Oncology, Director of Supportive Oncology, and Director 
of the Pain Management Center at the Fox Chase Cancer Center. 
Mr. Levy, the floor is yours.

                  TESTIMONY OF MICHAEL H. LEVY

    Mr. Levy. Thank you. Thank you, Chairman Greenwood, and, 
Mr. Bass, for inviting me to speak at this hearing. I also am 
the Director of the Pain Management Center at Fox Chase Cancer 
Center, which is just about 15 minutes from here. And I think, 
given the content of our discussions, I would also note that I 
am the father of an 18-year-old daughter and a 21-year-old son, 
and have sensitivities to all of the issues.
    We see over 500 new patients in pain at our pain center 
each year, and at least a third of them have pain that is not, 
in fact, due to their cancer. So we see both chronic noncancer 
and cancer pain in patients with a history of cancer.
    I have spent the last 20 years of my career as an advocate, 
both individually and in national organizations, to improve 
pain management, pain assessment, organizations, such as the 
American Society of Clinical Oncology, the American Medical 
Association, the American Pain Society, and the American 
Academy of Hospice and Palliative Medicine, of which I was 
President in 1999.
    We are in the midst of two epidemics, the epidemic of 
unrelieved chronic pain, and the epidemic of OxyContin abuse. I 
speak today on behalf of the patients with chronic pain and the 
health care providers that care for them. The cure for the 
current OxyContin abuse epidemic must not increase the 
suffering of legitimate patients with chronic pain.
    OxyContin is one of the best painkillers that we have had 
available to us in the last decade. Ready access to it is 
essential to our ability to provide safe and effective comfort 
and function to thousands of patients throughout the country.
    To summarize the more scientific content I had in my 
written testimony, the cornerstone of the management of 
moderate to severe chronic pain is pharmacologic management. 
And we do that by an individual-tailored program of analgesic, 
and what we call coanalgesic medications, to get the best 
comfort and function for each patient. Optimal medical 
management requires us to select the best analgesic, the right 
dose, the right route of administration, the right schedule at 
the right interval. We are looking as a goal of dealing with 
persistent pain, of pain prevention, with then having 
breakthrough medications available for episodic or intermittent 
pain.
    Effective pain relief requires aggressive adjustment of the 
dose of the analgesic, prevention, and anticipation and 
management of side effects, the utilization of specific 
coanalgesic drugs based on the source of pain, and 
consideration of sequential trials of opioid analgesics. Much 
like hypertension medicines, arthritis medicines, each patient 
has a different reaction to each analgesic, and having a 
variety of them to find what is the best one to give comfort 
and function, has become an increasingly important tool for us.
    We have heard about the use of the Schedule II medications, 
which are on the World Health Organization's Ladder 3. They are 
the main medicines that we need to use in our patients who have 
moderate to severe pain. These medicines include Oxycodone, 
Morphine, Hydromorphone, and Fentanyl. The non-opioid 
analgesics, like Tylenol or Motrin, or the combination of 
Tylenol or Motrin with Codeine or Hydrocodone, have some role 
in acute episodic pain, but have either dose-limiting side 
effects or their own organ damage from the Tylenol and the 
Motrin that is not found in the single entity Schedule II 
drugs.
    Morphine has been the most common Schedule II, Step 3 
opioid that we have used in this country, and the standard for 
pain prevention was set with MS-Contin, the controlled-release 
form of Morphine, unlike OxyContin, being the controlled-
release form of Oxycodone. MS-Contin became into our hands over 
17 years ago and it has been the standard for providing good 
pain prevention with twice-a-day, 12-hour dosing.
    We started using Oxycodone in combination products, as you 
have heard other testimonies, Percocet, Percodan, and Tylox. 
These agents were limited in two ways for our severe pain 
patients. We couldn't give more than three Percocet without 
risking a person to have liver or kidney damage with too much 
Tylenol or Acetaminophen or too much aspirin and, with 
Hydrocodone then, too much Ibuprofen.
    Single-entity Oxycodone became available approximately 10 
years ago. And we quickly found in our clinic, and the 
literature supported, that there were many patients who had 
less side effects, better comfort and function with Oxycodone. 
But until 5 years ago, we were limited to having patients have 
to take their medicines then every 4 hours.
    We also found, when we were using short-acting Oxycodone, 
that there was less social stigma to Oxycodone. The patients 
who had been taking their Percocet or their Tylox or their 
Percodan after their injury, their car accident, their 
fracture, weren't as afraid of it as they were of anything that 
would contain Morphine. We then were able to extend the use of 
short-acting Oxycodone with the long-acting OxyContin and found 
that it was effective on a twice-a-day dose. Studies showed 
that it was effective for the control of pain caused by cancer, 
osteoarthritis, post-herpetic neuralgia, major surgery, and 
even degenerative spine disease. Studies showed that it was 
comparable and preferable to short-acting Morphine and to 
short-acting Oxycodone.
    In combined studies, OxyContin, on a milligram-per-
milligram basis, is approximately two times as potent as MS-
Contin. I could find no data in my review of the literature, or 
our clinical experience, that there was anything to say that 
Oxycodone had any greater risk for addiction than Morphine, 
Hydromorphone, or Fentanyl.
    OxyContin has been crucial for the relief of chronic pain 
because it has what we feel the characteristics of an ideal 
opioid. It has a short half life, so it doesn't accumulate like 
Methadone can. It has a long duration. We can give it twice a 
day and get better quality of life. It has very predictable 
pharmacology. That its dose relationship, its prediction, the 
variation from one patient to another, is much less than most 
of the other medications. It also does not have clinically 
active breakdown products, which has been reported in the last 
decade as being a problem with many patients who are taking 
high doses of Morphine.
    Its formulation also allows it to work even quicker than MS 
Contin when taken appropriately, so it makes it easy to get 
someone comfortable quickly. There is no ceiling, as there is--
as there was with Codeine. Studies have shown there is less 
side effects, particularly hallucinations, dizziness, and 
itching, and, up until now, there was minimal associated 
stigma. It was much easier for us to say you have been on 
Percocet. We can get you better pain relief with less danger to 
your liver by using OxyContin, which is the long-acting form of 
the medicine in Percocet than it would be, we need to use MS-
Contin because the public had this fear of Morphine.
    The stigma has been a real issue. I think one of the 
reasons that I see for the rapid rise in the appropriate use of 
OxyContin is that patients and physicians have been comfortable 
and know how to safely and effectively use Percocet and Tylox, 
but were afraid of Morphine. So when we got a medicine that 
was, okay, I know how to use Percocet. This is now the more 
effective better quality of life.
    Not only did we have better acceptance by our patient, but 
we had better utilization by orthopedic surgeons, by 
rheumatologists, by people treating very painful diseases or 
procedures who traditionally would not have used Morphine, were 
providing good comfort and function to these other chronic pain 
patients with OxyContin.
    As we have seen it in our very ill patients, because of its 
better chemistry, particularly in the patients with a very 
narrow window, those patients have been very--have benefited a 
lot in getting less side effects, particularly nausea or 
sedation.
    The rapid escalating abuse of OxyContin is a double 
tragedy. And we have heard from the first panel that there are 
things that we don't want to happen in our society. But we also 
have things that we don't want to happen in our patients after 
we spent the last 20 years trying to teach them how to report 
their pain, advocate for appropriate pain relief.
    This first tragedy is that the disease of addiction has 
found a new substance to abuse that, as has been mentioned, has 
a legal, pharmacy-based, distribution system created for the 
needs of appropriate chronic pain patients and the research and 
patient advocacy efforts of a legitimate, FDA-approved 
pharmaceutical corporation. This abuse violates the specific 
instructions of the FDA-approved OxyContin package label that 
states that it should only be taken orally and used for 
moderate to severe pain and should not be chewed or crushed.
    OxyContin abuse has increased the street value, as we have 
heard, and led to violent crimes from abuse pushers--abusers, 
pushers, and prescription diversion, by deviant physicians and 
pharmacists. The popularity of OxyContin abuse by addicts has 
also resulted in the inadvertent deaths of inexperienced drug 
abusers who were not tolerant to other opioids and were not 
aware of the relative potency of the different formulations of 
OxyContin.
    The second tragedy of OxyContin abuse is the fact that 
legitimate patients are having increasing difficulties in 
obtaining their appropriately prescribed OxyContin. The 
extensive media coverage of OxyContin abuse has made our 
patients afraid of taking their OxyContin due to resurfacing of 
their concerns of addiction and tolerance that we had dealt 
with appropriately with our patient education and support by 
our nurses and pharmacists and doctors when they first received 
their prescription. They are afraid of becoming victims of 
violent crime. They are--the reduced stigma that Oxycodone 
possessed has basically been destroyed.
    Even when patients have their concerns about OxyContin 
resolved by their health care providers, they are being 
pressured by their friends, family, and uniformed health care 
professionals to stop using it. My nurses and I have spent an 
additional 15 to 20 minutes of patient education in the last 
few months, counseling patients to just get them to use this 
excellent medication. Finally, as part of the efforts to reduce 
OxyContin abuse, pharmacies and prescription benefit programs 
are restricting sales, making it increasingly difficult for 
honest patients to obtain ready access to their appropriately 
prescribed OxyContin.
    Mr. Bass, you asked about remedies. State and Federal 
bodies and regulatory agents much take care not to increase the 
suffering of chronic pain patients by reducing access to 
adequate supplies of legally prescribed OxyContin in their 
efforts to control illegal OxyContin abuse.
    The medical community finds itself in a very tight spot. 
Heroic efforts have been spent over the last 20 years to 
improve pain management, to dispel the myths of opioid 
addiction and tolerance, yet study after study after study have 
documented that approximately 50 percent of patients with 
chronic pain are undermedicated.
    Beyond the Veterans Administration process that Dr. 
Friedman mentioned, the Joint Commission on Accreditation of 
Healthcare Organizations found it necessary to develop new 
standards for pain control to hold heath care organizations 
accountable for the system-wide inadequacy. The National Cancer 
Policy Board of the Institute of Medicine and the National 
Research Council recently, in their June report to the 
Congress, documented the persistence of unrelieved suffering in 
patients with advanced cancer and made specific recommendations 
to break down the barriers to excellent palliative care.
    The National Comprehensive Cancer Center and the American 
Cancer Society released in April Cancer Pain Treatment 
Guidelines for Patients to empower them and their families to 
seek out and obtain state-of-the-art cancer pain management. 
These efforts have increased the public expectation of 
effective pain management, as recently demonstrated in the 
California case of a physician being successfully sued for 
failure to relieve his patient's pain.
    Just when physicians are advocating or being pressured to 
provide better pain management, one of our best tools is being 
threatened. We have made significant gains in our fight to 
relieve pain and suffering, especially where medical science 
cannot eliminate the cause of that pain. We must not let these 
gains in preserving human dignity be lost.
    In conclusion, interventions aimed at reducing the public 
problem of OxyContin abuse must not interfere with the safe and 
effective use of OxyContin for the patient problem of 
unrelieved chronic pain. We must join together to halt both of 
these terrible epidemics, unrelieved pain and opioid abuse. The 
resolution of either of these tragedies must not intensify the 
severity of the other. We must work together to heal our 
society and reduce the suffering of its citizens.
    I, again, thank you for this opportunity to speak and look 
forward to responding to your questions.
    [The prepared statement of Michael H. Levy follows:]
   Prepared Statement of Michael H. Levy, Vice-Chair, Department of 
Medical Oncology, Director, Supportive Oncology Program, Director, Pain 
               Management Center, Fox Chase Cancer Center
                pharmacologic management of chronic pain
    There are four basic approaches to pain control: modify the source 
of pain, alter central perception of pain, modulate transmission of 
pain to the central nervous system, and block transmission of pain to 
the central nervous system (Jacox et al 1994, Levy 1996, Doyle et al 
1997, American Pain Society 1999). Systemic pharmacologic management 
aimed at the first three of these approaches is the cornerstone of the 
treatment of most patients with moderate to severe pain (Jacox et al 
1994, Levy 1996). Optimal pharmacologic management of pain requires 
selection of the appropriate analgesic drug, prescription of the 
appropriate dose, administration of the analgesic by the appropriate 
route, scheduling of the appropriate dosing interval, prevention of 
persistent pain and relief of breakthrough pain, aggressive titration 
of the dose of the analgesic, prevention, anticipation, and management 
of analgesic side effects, utilization of appropriate coanalgesic 
drugs, and consideration of sequential trials of opioid analgesics 
(Table 1.) (Levy 1996).
    The World Health Organization created a Three-Step Analgesic Ladder 
in 1990 (World Health Organization 1990). Step 1, non-opioid analgesics 
such as acetaminophen and non-steroidal anti-inflammatory drugs are 
limited to the treatment of mild pain due to their low maximal efficacy 
and their potential for end-organ toxicity. Step 2 opioid drugs such as 
codeine, and hydrocodone, and oxycodone are limited to the control of 
moderate pain due to the intrinsic dose-limiting side effects of 
codeine, their dose-limiting, fixed combinations with non-opioid, Step 
1 analgesics, and their availability only as immediate-release 
formulations. Relief of moderate to severe acute and chronic pain is 
best achieved with an opioid analgesic from Step 3 of the WHO Analgesic 
Ladder: morphine, oxycodone, hydromorphone, or fentanyl (Jacox et al 
1994, Levy 1996, American Pain Society 1999). Morphine has been the 
most commonly used Step 3 opioid analgesic for past thirty years. The 
introduction of MS Contin (controlled-release morphine), twenty years 
ago, set the standard for the control of chronic pain with just twice-
a-day, analgesic dosing (Hanks 1989, Thirwell et al 1989).
                  oxycontin: an ideal opioid analgesic
    Oxycodone became extended from Step 2 to Step 3 with the 
availability of single-entity immediate-release oxycodone (IRO) tablets 
and liquids. Clinical studies and practical experience with these 
formulations showed that oxycodone had no apparent dose ceiling, less 
side effects than other opioids in individual patients, and less social 
stigma than morphine (Kalso and Vaino 1990, Glare and Walsh 1993, Levy 
1996). OxyContin has been available in the USA for five years and has 
been shown to be effective in the control of pain caused by cancer 
(Hagen and Babul 1997, Citron et al 1998), osteoarthritis (Caldwell et 
al 1999, Roth et al 2000), post-herpetic neuralgia (Watson and Babul 
1998), major surgery (Sunshine et al 1996), and degenerative spine 
disease (Hale et al 2000). OxyContin is comparable and preferable to 
IRO and is comparable to MS Contin for the control of cancer pain 
(Bruera et al 1998, Kaplan et al 1998, Mucci-LoRusso et al 1998). 
OxyContin is approximately twice as potent as MS Contin on a milligram 
per milligram basis (Bruera et al 1998, Curtis et al 1999).
    OxyContin has the characteristics of an ``ideal'' opioid analgesic 
drug: short half-life, long duration of action, predictable 
pharmacokinetics, absence of clinically active metabolites, rapid onset 
of action, easy titration, no ceiling dose, minimal adverse effects, 
and minimal associated stigma (Table 2.). Oxycodone has a serum half-
life of 3-5 hours with steady state reached in 24-36 hours (Kalso and 
Vaino 1990, Glare and Walsh 1993). Double-blind studies have shown that 
OxyContin given every 12 hours is as effective as an equivalent dose of 
IRO given every 6 hours (Kaplan et al 1998, Hale et al 2000). OxyContin 
has a biphasic absorption with a minor, initial peak at 0.6 hours and a 
secondary, major peak at 6.2 hours (Kaiko et al 1996b, Mandema et al 
1996, Benziger et al 1997). Clinical analgesia has an onset within 1 
hour and a duration of 12 hours (Mandema et al 1996, Sunshine et al 
1996). The bioavailability of oxycodone is 60-87% which increases the 
predictability of its pharmacokinetics (Kalso and Vaino 1990, Kalso et 
al 1991, Reder et al 1996). Clinically, the predictable 
pharmacokinetics of OxyContin are demonstrated by the independence of 
its dissolution on pH and the high correlation of its dose with its 
plasma level (Kaiko et al 1996b, Benziger et al 1996, Kaiko 1997, 
Mucci-LoRusso et al 1998, Mandema et al 1998). OxyContin's 
bioavailability is increased by 15% in the elderly and approximately 
50% in renal dysfunction (Kaiko et al 1996b, Kaiko 1997, Mucci-LoRusso 
et al 1998, Mandema et al 1998). OxyContin has less plasma variation 
than morphine (Colucci et al 1998) and has no clinically significant 
active metabolites (Kaiko et al 1996a, Heiskanen et al 1998). The time-
action of oxycodone's drug effect coincides with its time-
concentration. Its drug effect is not altered by inhibition of 
oxymorphone formation with quinidine (Kaiko et al 1996b, Heiskanen et 
al 1998). Because of its biphasic absorption, OxyContin has an onset of 
pain relief of 46 minutes, which is almost as rapid as the analgesic 
onset of IRO at 41 minutes (Sunshine et al 1996, Kaiko 1997). The mean 
time to peak pain relief for 40 mg of CRC is 1:29 hours compared to 
2:20 hours for MS Contin (Sunshine et al 1996, Kaiko 1997). Combined 
data from several controlled studies with OxyContin and MS Contin 
showed that OxyContin was easily titratable and had no ceiling dose 
(Kaiko et al 1996b, Heiskanen and Kalso 1997, Mucci-LoRusso et al 1998, 
Bruera et al 1998, Curtis et al 1999). The average daily dosage of 
OxyContin in these studies was 120 mg with an equianalgesic ratio of 
morphine to oxycodone of 2:1 (Mucci-LoRusso et al 1998, Bruera et al 
1998, Curtis et al 1999). Common opioid-induced adverse effects were 
minimal with OxyContin and diminished over time with the same tolerance 
observed with other opioids (Bruera et al 1998, Kaplan et al 1995). 
Fewer patients taking OxyContin experienced severe adverse effects and 
more had no adverse effects compared to patients taking MS Contin 
(Mucci-LoRusso et al 1998). Patients taking OxyContin experienced less 
hallucinations and dizziness (Mucci-LoRusso et al 1998, Reder et al 
366, Weinstein et al 1998) or scratching and itching than those taking 
MS Contin (Mucci-LoRusso et al 1998). This latter observation might be 
accounted for by the speculation that oxycodone may have less 
propensity to stimulate histamine liberation than morphine (Flacke et 
al 1987, Poyhia et al 1992). Clinical practice has shown that oxycodone 
has less associated stigma than morphine. Many healthcare providers and 
patients associate morphine, but not oxycodone, with advanced illness, 
impending death, and high risk of addiction (Fitzmartin and Reder 
1995). In the United States, combinations of oxycodone plus 
acetaminophen or aspirin have been used for years as Step 2 opioids for 
moderate chronic pain and moderate to severe acute pain resulting in 
greater familiarity and comfort with prescribing and taking oxycodone 
than morphine (Reder and Fitzmartin 1995, Levy 1996, Caldwell et al 
1999). OxyContin's freedom from acetaminophen or aspirin facilitates 
upward dose titration and its 12-hour duration provides a significant 
patient convenience over 4-hourly immediate-release opioids. OxyContin 
has been shown to decrease pain and improve function in osteoarthritis 
(Caldwell et al 1999, Roth et al 2000), post-herpetic neuralgia (Watson 
and Babul 1998), major surgery (Sunshine et al 1996), and degenerative 
spine disease (Hale et al 2000)
    In summary, OxyContin is comparable and preferable to immediate-
release oxycodone for the control of chronic cancer pain. OxyContin is 
comparable to MS Contin for the control of chronic cancer pain and is 
approximately twice as potent as MS Contin on a milligram per milligram 
basis. MS Contin is also effective for the control of osteoarthritis 
pain, post-herpetic neuralgia, acute post-operative pain, and chronic 
low back pain. OxyContin has the attributes of an ideal opioid: short 
half life, long duration of action, predictable pharmacokinetics, no 
clinically significant active metabolites, rapid onset of action, easy 
titration, no ceiling dose, minimal adverse effects, and minimal 
associated stigma (Evans 1999). Its multiple dosing forms permit its 
early use and individualized titration to optimal comfort and function 
in most patients with moderate to severe pain. The benefit of OxyContin 
can be optimized by the use of immediate-release oxycodone for 
breakthrough pain and would be greatly facilitated by wider access to 
parenteral oxycodone for patients temporarily unable to use the oral 
route. Its potential for less adverse side effects, relative to 
morphine, might be even more advantageous for sicker patients with 
narrow therapeutic windows for opioid analgesics.
                   oxycontin abuse: a double tragedy
    The rapidly escalating abuse of OxyContin in the last year is a 
double tragedy. The first tragedy is the fact that individuals with the 
disease of addiction have found a new substance to abuse that has a 
legal, pharmacy-based, distribution system created by the needs of 
appropriate chronic pain patients and the research and patient advocacy 
efforts of a legitimate, FDA-approved pharmaceutical corporation. 
OxyContin abuse by these individuals has led to violent crimes by these 
individuals and to prescription diversion by deviant physicians and 
pharmacists to profit from OxyContin's increased street value. The 
popularity of OxyContin abuse by addicts has also resulted in the in 
the inadvertent deaths of first time drug abusers who were not tolerant 
to opioids and were not aware of the relative potency of the different 
formulations of OxyContin available.
    The second tragedy of OxyContin abuse is the fact that legitimate 
pain patients are having increasing difficulty utilizing their 
appropriately prescribed OxyContin. The extensive media coverage of 
OxyContin abuse has made patients afraid of taking their OxyContin due 
to resurfacing of their concerns of addiction and tolerance that had 
been accurately addressed by their physicians and nurses when they 
received their first prescription. Patients are also afraid of being 
victims of violent crime by addicts or dealers who want their 
prescriptions or their OxyContin pills. The reduced stigma that 
oxycodone once possessed compared to morphine has decayed. Even when 
patients have their concerns about using OxyContin resolved by their 
health care providers, they are being pressured by their friends, 
family, and uninformed, health care professionals to stop using it. 
Finally, as part of their efforts to reduce OxyContin abuse, pharmacies 
and prescription benefit programs are restricting OxyContin sales, 
making it increasingly difficult for honest patients to obtain ready 
access to their appropriately prescribed, OxyContin.
remedies for oxycontin abuse must not interfere with relief of chronic 
                                  pain
    Regulatory agencies such as the FDA and DEA must take care not to 
increase the suffering of chronic pain patients by reducing access to 
adequate supplies of legally prescribed OxyContin in their efforts to 
control illegal OxyContin abuse. Despite heroic efforts over the past 
twenty years by individual and organizations to redress the balance of 
medicine and ensure appropriate assessment and treatment of chronic 
pain, surveys still show that half of the patients in this country with 
chronic pain are undertreated. Last year, the Joint Commission on 
Accreditation of Healthcare Organizations (JCAHO) found it necessary to 
develop new standards for pain control to address this system-wide 
inadequacy. The National Cancer Policy Board of the Institute of 
Medicine and the National Research Council recently underscored the 
persistence of unrelieved suffering in patients with advanced cancer 
and made specific recommendations to break down the barriers to 
excellent palliative care (Foley and Gelband, 2001). The National 
Comprehensive Cancer Network and the American Cancer Society have just 
released Cancer Pain Treatment Guidelines for Patients to empower 
patients and their families to seek out and obtain state-of-the-art 
cancer pain management. As an example of the increasing public 
expectation of effective pain management, a California physician was 
just successfully sued for failure to relieve his patient's chronic 
pain. Interventions aimed at reducing the public problem of OxyContin 
abuse must not interfere with the safe and effective use of OxyContin 
for the patient problem of unrelieved chronic pain.

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1990.

    Mr. Greenwood. Thank you, Dr. Levy, for your excellent 
testimony, and we appreciate that. And, finally, Nurse Terry 
Atwood. Thank you for being with us.
    Ms. Atwood. Thank you.
    Mr. Greenwood. And don't be intimidated by these 
microphones in your face.
    Ms. Atwood. Sure.

                   TESTIMONY OF THERESA ATWOOD

    Ms. Atwood. My name is Theresa Atwood. In the recent past, 
I have practiced nursing in Philadelphia, Bucks, and Delaware 
Counties, and I am a resident of Delaware County. I am a 
Registered Nurse, certified by the American Nurses' 
Credentialing Center in the specialty of Psychiatric and Mental 
Health Nursing. I hold a Master of Human Services Degree and am 
a member of the American Psychiatric Nurses' Association, as 
well as the American Counseling Association.
    As a mental health/addictions professions, a family member 
of people who suffer from, or are in recovery from the disease 
of addiction, and as a person who is also in recovery from this 
disease, I have continuous exposure to it, in its many forms, 
and in its various stages of progress and outcomes. I am 
grateful you have granted me the honor of speaking here today.
    In considering the escalation of the number of people 
becoming addicted to, and dying from, the misuse of OxyContin, 
it is important to realize that its respiratory depressant 
effects can be lethal with any, including the initial use, that 
is not monitored by a physician. The likelihood of death is 
increased because when used in conjunction with alcohol and 
other sedatives, as is the practice among many teenagers, the 
respiratory-depressant effects are potentiated. The rapid 
increase in the number of young people able to access and 
consequently abuse OxyContin is intensely apparent in my daily 
practice.
    Many, if not most, of the adolescents I come in contact 
with are well aware of how ``good'' the ``Oxy's'' are. When I 
ask my young patients if they realize that OxyContin is just 
as, if not more, deadly than heroin, they respond with great 
skepticism and apathy because they view OxyContin as a 
medicine, not a street drug, making it more attractive to a 
wider variety of teens. These young people consider OxyContin 
to be a cleaner, prettier, more powerful form of heroin.
    Although they are vastly informed of the positive euphoric 
potency of OxyContin, they have little, if any, information 
about its often fatal respiratory depressant and other side 
effects, and the eventual withdrawal syndrome. This lack of 
knowledge and lack of concern for their own existence is 
evident as the freely admit to, and even brag about, 
supplementing OxyContin use with alcohol and other opioids, a 
practice that has proven to have detrimental consequences.
    Upon entering treatment, often as a result of legal or 
familial force, adolescents are resistant to intervention or 
education. This opposition is not only a result of their 
inherent developmental ideology of independence, omnipotence, 
and immortality, but also because OxyContin provides the 
ultimate in escapism. I have watched young people walk out of 
treatment centers, risking imprisonment, homelessness, the loss 
of families, including the loss of their own small children, 
and even the loss of their own lives, rather than face the 
prospect of life without OxyContin and other drugs.
    The horrible dilemma of OxyContin misuse recently hit home 
for me. My relative had been in a car accident, suffered spinal 
trauma, and was being treated with Percocet for a number of 
years. As his tolerance to the Percocet increased, his 
physician began to utilize OxyContin to manage his back pain. 
Once he was introduced to OxyContin, he required more and more 
of it. He was initially prescribed 10 milligrams, then 20, then 
40, 80, and finally 160 milligrams. At the conclusion of his 
active use, he was taking up to four 160-milligram OxyContins, 
with Percocet, Soma, and Fioricet, a day, an amount which, by 
all accounts, could have easily been fatal.
    He states that once addicted, he began chewing the 
OxyContins, despite the accompanying nausea and gagging. He 
tells me that as he would be picking up a prescription, his 
mind would be racing to figure out a way to get the next one. 
He offered many excuses to physicians, such as his son spilled 
the pills down the sink, or his car was robbed. He admits to 
loss of libido, lack of motivation, outside of obtaining the 
pills, and wide mood swings. He says, I didn't want sex. I had 
no feelings. All that I thought about was getting the next 
script.
    After many months, his wife began threatening to leave him 
and his performance and relationships at work began to suffer. 
This didn't happen when I practiced. He knew he needed to stop 
using the medications, and he states he really wanted to, but 
despite all thoughts, desires, and actions to the contrary, he 
continued and increased his use. He tells me, as I sat there 
watching everything I had ever wanted, my wife and family, 
packing up and walking out the door, I literally couldn't even 
move to stop it. I was so screwed up.
    Currently, my family member has 96 days cleans and he just 
got a promotion at work, but he adds, my wife is still gone. 
After long-term treatment experience, he was able to obtain 
recovery thus far. Maintaining his recovery is difficult and 
requires much outside support. He now uses a non-narcotic 
prescription medication to manage his back pain, which he 
assures me works well, however, his insurance won't pay for it. 
Ironically, they paid over $100,000 for the OxyContin he took. 
Obviously, there is a blaring need for quality treatment for 
those who become addicted to this medication.
    To summarize, those patients for whom it is truly 
indicated, OxyContin is absolutely beneficial and necessary, 
however, for those who recreationally use it, or become 
addicted, it is just as powerfully destructive. Thank you all 
for your time and attention, and I implore you to ask me any 
questions you may have.
    [The prepared statement of Theresa Atwood follows:]
        Prepared Statement of Theresa Attwood, Registered Nurse
    My name is Theresa Attwood. I am a registered nurse, certified by 
the American Nurses' Credentialing Center in the specialty of 
Psychiatric and Mental Health Nursing. I hold a Master of Human 
Services Degree and am a member of the American Psychiatric Nurses 
Association as well as the American Counseling Association. As a mental 
health/ addictions professional, a family member of people who suffer 
from, or are in recovery from the disease of addiction and as a person 
who is also in recovery from this disease, I have continuous exposure 
to it in it's many forms and in its various stages of progress and 
outcomes. I am grateful you have granted me the honor of testifying 
here today.
    In considering the escalation of the number of people becoming 
addicted to, and dying from, the misuse of OxyContin, it is important 
to realize that its respiratory-depressant effects can be lethal with 
any, including the initial use, that is not monitored by a physician. 
The likelihood of death is increased because when used in conjunction 
with alcohol and other sedatives, as is the practice among many 
teenagers, the respiratory-depressant effects are potentiated. The 
rapid increase in the number of young people able to access and 
consequently abuse OxyContin is intensely apparent in my daily 
practice.
    Many, if not most, of the adolescents I come in contact with are 
well aware of how ``good'' ``Oxys'' are. When I ask my young patients 
if they realize that OxyContin is just as, if not more, deadly than 
heroin, they respond with great skepticism and apathy because they view 
OxyContin as a medicine--not a street drug, making it more attractive 
to a wider variety of teens. These young people consider OxyContin to 
be a cleaner, prettier, more powerful form of heroin. Although they are 
vastly informed of the positive euphoric potency of OxyContin, they 
have little, if any, information about it's often fatal respiratory 
depressant effects and the eventual withdrawal syndrome. This lack of 
knowledge, and lack of concern for their own existence, is evident as 
they freely admit to, even brag about, supplementing OxyContin use with 
alcohol and other opioids--a practice that has proven to have 
detrimental consequences. Upon entering treatment, often as a result of 
legal or familial force, adolescents are resistant to intervention or 
education. This opposition is not only a result of their inherent 
developmental ideology of independence, omnipotence, and immortality, 
but also because OxyContin provides the ultimate in escapism. I have 
watched young people walk out of treatment centers, risking 
imprisonment, homelessness, the loss of families--including the loss of 
their own small children, and even the loss of their own lives, rather 
than face the prospect of life without OxyContin and other drugs.
    The horrible dilemma of OxyContin misuse recently hit home for me. 
My relative had been in a car accident, suffered spinal trauma, and was 
being treated with percocet for a number of years. As his tolerance to 
the percocet increased, his physician began to utilize OxyContin to 
manage his back pain. Once he was introduced to the OxyContin, he 
required more and more of it. He was initially prescribed 10 mg, then 
20, then 40, 80, and finally 160 mg. At the conclusion of his active 
use, he was taking up to four 160mg OxyContins, with percocet, soma and 
fiorecet, a day--an amount which, by all accounts, could have easily 
been fatal. He states that once addicted, he began chewing the 
OxyContins, despite the accompanying nausea and gagging. He tells me 
that as he'd be picking up a prescription, his mind would be racing to 
figure out a way to get the next one. He offered many excuses to 
physicians, such as: his son spilled the pills down the sink or his car 
was robbed. He admits to loss of libido, lack of motivation (outside of 
obtaining pills) and wide mood swings. He says, ``I didn't want sex, I 
had no feelings, all that I thought about was getting the next 
script.'' After many months, his wife began threatening to leave him 
and his performance and relationships at work began to suffer. He knew 
he needed to stop using the medications, and he states he really wanted 
to, but despite all thoughts, desires and actions to the contrary, he 
continued and increased his use. He tells me, ``As I sat there watching 
everything I had ever wanted, my wife and family, packing up and 
walking out the door, I literally couldn't even move to stop it--I was 
so screwed up.'' Currently, my family member has 96 days clean and he 
just got a promotion at work, but he adds, ``my wife's still gone''. He 
now uses a non-narcotic prescription medication to manage his back 
pain, which he assures me works well, however, his insurance won't pay 
for it--ironically, they had paid over $100,000 for the OxyContin.
    To summarize, to those patients for whom it is truly indicated, 
OxyContin is absolutely beneficial and necessary, however, for those 
who recreationally use it, or become addicted, it is just as powerfully 
destructive.
    Thank you for your time and attention.

    Mr. Greenwood. Thank you very much for your testimony. It 
never happens when you practice it. It gets real here. Thank 
you very much. Dr. Friedman, let me begin with you. Is it Dr. 
Friedman?
    Mr. Friedman. It is Mr. Friedman. Thank you.
    Mr. Greenwood. Look, we stipulate, I stipulate, yours is a 
good company with a long and exemplary record in, as I said, in 
my opening statement, relieving pain. And I believe that your 
product and your company has done, by orders of magnitude, more 
to relieve pain in this country than to cause it. There is no 
question about that. It is also clear that, as the last witness 
indicated, it has caused a lot of pain, as well.
    When you have a--it seems to me that when you have a 
product that is this powerful, and that is what this drug is, 
this is a powerful drug--there are a couple of things that you 
want to do. You want to make sure, as hard as you can, that it 
gets into the hands of people who are suffering. And you try--
and you do that very aggressively. It seems to me, equally as 
obvious, that you have to do all that you can in making an 
equal effort to make sure that this drug is not abused to the 
extent that you can. And it doesn't cause anguish, because the 
anguish of the families sitting here to our right will go on 
forever over the loss of their young son.
    It is clear that your company did an extraordinary job in 
the first case. Marketing was aggressive, even aggressive by 
today's market expandance. Make sure that you research the 
markets. You had an aggressive sales force. You have got 
seminars that you put on and so forth.
    The question is--and you are not on trial here. The 
question is, has the company done enough to prevent the 
misdirection--you knew going into it--you had to know going 
into it that this is a product that is likely to be diverted to 
the street, it is likely to become addictive, it is likely to 
be stolen, it is likely to become lethal when used not 
according to directions.
    So I guess the questions that I have for you are, what have 
you done along those lines and have your efforts been--you have 
$1.25 billion in sales a year, if my numbers are correct, 83 
percent of your revenue as a result of your very aggressive 
marketing. How aggressive have you been in the other half of 
your responsibility, and that is, to protect the public from 
the negative consequences of this product? And how might we be 
of assistance to you with regard to this product and other 
products in creating tools for law enforcement, tools for the 
monitoring of these products, education efforts? Tell us how we 
can be not just accusers here, but how we can be part of the 
solution?
    Mr. Friedman. Mr. Chairman, thank you. Purdue would like to 
take a lead role in helping to solve this problem. And we have 
worked diligently, as long as we have been marketing narcotic 
analgesics, to market them responsibly. When we launched MS-
Contin in 1984, that product required a great deal of 
education, because up until that time, many physicians, 
including oncologists, did not see the importance of the need 
to control pain. When we made visits to oncologists back then, 
we were told, at times, our job is to cure the cancer. Pain is 
not the focus of our practice.
    But since 1984, we have seen a see change in medical 
thinking. But all through that time, that see change took place 
as a result of a great deal of education. We knew that in order 
to use these products properly and responsibly, physicians 
would need education. They would need information and they 
would need tools. And we have sought, through that entire 
period, to provide those tools.
    As we marketed MS-Contin, up to the launch of OxyContin in 
1995, the end of 1995, we saw very little evidence of abuse and 
diversion of MS-Contin. When we launched OxyContin, we saw very 
little evidence of abuse and diversion until some time around 
2000, which, based on the testimony I have heard from other 
panelists, is the time that, in general, that type of abuse and 
diversion was noticed.
    But we are doing much more than our medical education and 
other programs. We have been working very hard to develop 
products that would be resistant to abuse and diversion, as 
well, which we think is an important long-term solution.
    Mr. Greenwood. I addressed some questions to the 
representative of the Drug Enforcement Agency about data that 
is available. In informal conversations with representatives of 
your company, I have been led to understand that there is a 
private entity that creates a data base that I thought provided 
the data in terms of prescriptions per physician, and that your 
company, in fact, acquires that data on an ongoing basis and 
has that data. Can you summarize that for us? What does your 
company know about how many prescriptions each physician writes 
for your OxyContin?
    Mr. Friedman. We do acquire data very much along the lines 
that you describe, Mr. Chairman. We acquire it from IMS Health. 
IMS Health captures this data through the computers at 
pharmacies. Of course, certain patient information is excluded 
to protect the patient's right to privacy.
    Mr. Greenwood. Like, for instance, if Dr. Paolino here in 
Buckingham--Bensalem, wrote 1,200 prescriptions in the 5-month 
period, that is data that you would have had. Correct?
    Mr. Friedman. Correct.
    Mr. Greenwood. Okay. Now, when you have that data, I would 
guess that one of the things that you would do with that data 
is arrange it so that you can take a look at--you can rank 
these physicians. You have some indication as to who is writing 
the most, who is writing the least, and in between, and who the 
outliers are. Do you have--do you look at that information in 
that way?
    Mr. Friedman. Yes. The only comment that I would add is 
that we get the data somewhat after the actual event of the 
prescription. There is a 6 to 8-week lag.
    Mr. Greenwood. Okay. But assuming that Dr. Paolino was a 
great outlier, very abusive individual, who wrote this without 
any regard whatsoever for the medical condition of the 
patients, wrote these prescriptions as fast as he could purely 
for profit-making purposes. What does your--I would think that 
Dr. Paolino--I would hope that he would have stuck out like a 
sore thumb and that there must be other Dr. Paolinos in this 
country who do the same--take the same kind of approach, and 
that that information would be aware--that your company would 
be aware of that kind of information. The question then is, how 
do you respond to that, when you see a doctor who is not 
associated with Fox Chase Cancer Center, and is just a little 
osteopath here in Bensalem, doing this vast number? What do you 
do with that information?
    Mr. Friedman. Well, we have learned over the years that the 
absolute number of prescriptions that a physician is 
prescribing is, in and of itself, not an indicator of the 
doctor doing something wrong. We don't measure or assess how 
well a physician practices medicine. We are not in the office 
with a physician and a patient observing the examination or 
involved in that process. We know, for example----
    Mr. Greenwood. Well, why do you want that information then?
    Mr. Friedman. Well, we use that information to understand 
what is happening in terms of the development of use of our 
product in any area.
    Mr. Greenwood. And so the use of it--and I assume that part 
of it--a large part of it you want is to see how successful 
your marketing techniques are so that you can expend money in a 
particular region or among a particular group of physicians--
you look to see if your marketing practices are increased in 
sales. And, if not, you go back to the drawing board with your 
marketers and say, how come we spent ``X'' number of dollars, 
according to these physicians, and sales haven't responded. You 
do that kind of thing. Right?
    Mr. Friedman. Sure.
    Mr. Greenwood. Okay. So it would seem to me that you would 
also have a responsibility--see, this is what I am getting out 
of my first question. You took all that data and you looked at 
it for the first part, to see how you were doing in the first 
part of your responsibility--get the product out, increase 
sales, increase revenues. Okay. Did you look at the data with 
a--in response to your last question, you said we don't look to 
see how physicians are practicing medicine. Well, that is the 
other side of your responsibility. Why wouldn't you have been 
using this data to make sure that the Dr. Paolinos of the world 
weren't wrecking the reputation of your product?
    Mr. Friedman. I think Mr. Udell might be able to respond to 
that more further.
    Mr. Udell. One of the----
    Mr. Greenwood. Well, perhaps he can pull up a chair and 
speak into the microphone, Mr. Udell. Maybe I can stand here. 
There isn't a chair. Mr. Chairman, one of the things----
    Mr. Greenwood. Well, you need to talk into this microphone 
here.
    Mr. Udell. Thank you, Mr. Chairman. One of the things that 
we learned when we visited with law enforcement around the 
country when this problem first arose, was what Mr. Friedman 
said, that drug enforcement people tell us that you can't look 
at prescriptions alone. You have to look at what the doctor is 
actually doing in the office. And apparently that happened 
here. But that is not something----
    Mr. Greenwood. Well, you didn't do it.
    Mr. Udell. That happened here in terms of law enforcement.
    Mr. Greenwood. Well, and local pharmacists saw----
    Mr. Udell. Correct.
    Mr. Greenwood. He had rough data----
    Mr. Udell. Right.
    Mr. Greenwood. [continuing] that you had. And he saw, from 
his perspective--he looked at this data and he said, Holy God, 
there is some guy in Bensalem----
    Mr. Udell. That is right.
    Mr. Greenwood. [continuing] called Paolino and he is 
writing prescriptions out the wazoo.
    Mr. Udell. Yes.
    Mr. Greenwood. Now, he had that data and he blew the 
whistle.
    Mr. Udell. Correct.
    Mr. Greenwood. And you had that data. What did you do?
    Mr. Udell. Well, we didn't have the data that he had. We 
didn't know that you had a physician a distance away writing 
prescriptions that were filled in a particular pharmacy. I 
think that that is what alerted that pharmacy, at least as I 
understand the reports in the paper.
    What I am trying to say is that our sales representatives 
have a couple of minutes with a doctor. They talk to the doctor 
about the product and they leave. Law enforcement tells us that 
high numbers, high numbers of prescriptions, may or may not be 
a signal. They may not be, even if he is not at Fox Chase, even 
if he is a rural physician. It is not necessarily a signal. 
What they have to do is, they have to get in there and try to 
find out. It is a very difficult task. They have explained to 
me again and again, that trained investigators--and you heard 
from Mr. Demarest earlier, and he is one of those kinds of 
investigators--trained investigators can go in there and try to 
assess these things.
    Mr. Greenwood. Let me interrupt you.
    Mr. Udell. Our people just don't have the----
    Mr. Greenwood. Let me interrupt you for a second. And I 
don't want to be too harsh here. But, look, the law enforcement 
people have a million things to do.
    Mr. Udell. Yes.
    Mr. Greenwood. And they are not getting $1.25 billion a 
year to do it. They are all stretched, in terms of time, 
manpower, and budget. Okay.
    Mr. Udell. Yes.
    Mr. Greenwood. It seems to me that your company has a 
responsibility to be looking at this data and not relying on 
what law enforcement tells you, but saying what does Purdue 
Pharma have as a responsibility to do with the data that we 
have that tells how many doctors are selling--which doctors are 
writing how many prescriptions----
    Mr. Udell. Yes.
    Mr. Greenwood. [continuing] and how do we make sure that 
those are all good prescriptions, and weed out the bad actors? 
It is in your interest to do that.
    Mr. Udell. Yes.
    Mr. Greenwood. And I don't understand why that hasn't been 
something that you have been aggressively doing.
    Mr. Udell. It is absolutely in our interest to do so. And I 
think that we have all learned a lot from the case of Dr. 
Paolino. If we are to--the story, the picture that is painted 
in the newspaper is of a horrible, bad actor, someone who has 
preyed on this community, who has caused untold suffering. And 
he fooled us all. He fooled law enforcement. He fooled the DEA. 
He fooled local law enforcement. He fooled us. None of us, 
until a certain point in time, had an understanding that 
something wrong was going on there. And I think that we all 
have to learn from that. I think you are absolutely correct. We 
have to learn from this experience and we have to examine 
ourselves, is there more that we can do? Is there more that DEA 
can do? Is there more that local law enforcement can do? Is 
there more that we can do?
    Now, we are examining that. We have spoken to the sales 
representative who called on this doctor. And there came a 
point in time when she was alerted--she was alerted by a----
    Mr. Greenwood. But if I can interrupt you, we have had this 
conversation before. And it seems to me part of the problem is 
that your sales force gets paid on a commission basis, and the 
more they sell, the better they do.
    Mr. Udell. Yes.
    Mr. Greenwood. So it is awfully hard to imagine that they 
would be the people in your organization who would go out and 
tell the doctors you are making me too much money. You are 
writing----
    Mr. Udell. We would----
    Mr. Greenwood. You are writing too many prescriptions.
    Mr. Udell. Mr. Chairman, I don't know how clearly I can put 
this. Our sales force understands that the survival of the 
company, the product, and their livelihood, depends on them 
doing the right thing and making sure that the doctors who 
write these prescriptions write them properly. They understand 
that that is job No. 1.
    In areas where we have seen abuse and diversion, and as I 
spoke with staff and discussed with staff earlier, in areas 
where we anticipated that there might be abuse and diversion, 
we have tried to get out in front of the problem. And Mr. 
Friedman has talked to his sales people and he has said to 
them, your job is not to sell OxyContin. Your job is to go in 
there and try to be a part of the solution and to say to these 
doctors, you must write these prescriptions correctly. You must 
keep appropriate records. You must comply with State Medical 
Board regulations and DEA regulations. We have tools. We have 
devices. We have techniques to help you do so. And if you are 
not prepared to do so, do not write our product. Please, do not 
write our product.
    So while it is correct that there is a--there may be an 
incentive to extol the virtues of the product, there is clearly 
a greater incentive to make sure that the product is not 
written inappropriately. Dr. Paolino has done more to harm the 
company and the product than perhaps anyone in the country. 
There is no reason why we would want to do anything to support 
those kinds of activities or encourage them or countenance 
them, if we are capable of stopping it.
    Mr. Greenwood. I am going to yield now--if there is another 
Dr. Paolino in the country or 10 of them, there is--my guess is 
that there are--some of them are going to emerge, and I hope 
that you would take the step to prevent that. The Chair yields 
to the gentleman from New Hampshire to inquire.
    Mr. Bass. Thank you very much, Mr. Chairman. Sir, I think 
you might as well remain up there. What is your name again? I 
am sorry.
    Mr. Udell. Howard Udell.
    Mr. Bass. Mr.--Attorney Udell, what exactly are you doing 
today, tomorrow, or next week, to prevent incidents like the 
one just discussed----
    Mr. Udell. Yes.
    Mr. Bass. [continuing] from ever happening again?
    Mr. Udell. Yes. Well, perhaps Michael--perhaps, you would 
want to talk about the program.
    Mr. Bass. Without--but, be specific, please.
    Mr. Udell. Yes. Sure.
    Mr. Bass. You have the data. You know that 1,200 
prescriptions in 5 months is not the norm. Perhaps, you may not 
have noticed it because you weren't expecting it. What are you 
doing now to assure that your product is not abused in any--in 
this manner ever again?
    Mr. Friedman. Well, if I could comment briefly? When this 
problem first cropped up, it was a surprise to many. And when 
we heard about the problem, we first had to go learn more about 
it. And personally, I have traveled to visit the Attorneys 
General in 10 States where the problem seemed to be most 
prevalent. I have met with--when the problem was first 
identified with U.S. Attorney McCloskey in Maine and U.S. 
Attorney Crouch in Virginia, at those meetings, they helped us 
to understand the problem and helped us define things we could 
do that were beyond the things we were doing at that time.
    We also learned the nature of the problem. Because the 
first question that I asked was, where is this coming from? 
What is the source of this diverted drug? And what we were 
told, at the time, and what seems to be the prevalent thinking 
today, is that the first source is some kind of prescription 
fraud, copied prescriptions, altered prescriptions, stolen 
prescriptions. A second type of problem is some kind of 
fraudulent prescribing or error in prescribing. And we tried to 
set up programs working with law enforcement that would address 
those specific things. So, for example, we developed a program 
and a campaign to provide physicians with tamper-resistant 
prescriptions.
    But one of the other things we recognized that we needed, 
and others needed, was information. In order to identify a Dr. 
Paolino, or some other person abusing--you know, writing drugs 
that was creating a pattern of abuse, we needed a system for 
figuring that out. We didn't know how to identify abuse.
    And so what we did was, we, first of all, looked at the 
available data sources. But since that time, what we have done 
is we have convened a panel of experts to help us design a 
data-gathering system, an information system, and a warning 
network for ourselves. Because absent such a system existing, 
we need some way of reaching out and understanding where is 
abuse going on. Because we have learned that the number of 
prescriptions is not indicative, in and of itself, of abuse. We 
need to know more. And these experts are helping us develop 
such a system so that we can identify the places where abuse 
and diversion is going on and design some kinds of 
interventions.
    Mr. Bass. Okay. Tell me, Mr. Friedman, that you consider 
this issue to be a crisis for your company. You have got $1.27 
billion apparently in revenues. You have the resources to be 
very aggressive, and you have the interest to do it, as well. 
And understanding the nature of the problem, developing 
information, and establishing a panel to study it, and to try 
to understand it. The mysteries of it are certainly 
commendable. But those things ought to be done in a matter of 
weeks, not months or years. You ought to have--and it is none 
of my business--but you ought to have an office within your 
organization that is responsible for internal investigations 
and develop relationships with law enforcement community, 
because it isn't in your best interest to have these people 
writing all these prescriptions like this.
    And, frankly, I am not impressed with panels and study 
problems, and calling people on the telephone to try to figure 
it out. You have access to the data already. Now, I mean, that 
seems to be obvious to me. But there are other things that you 
could do. And I wanted to know if I could ask--first of all, I 
would love it if you would tell me that you are going to be 
more aggressive in establishing panels and trying to understand 
the issue better--that you are really going to do something to 
solve it, that is substantive, quick, and effective.
    Second, let me ask you, are there other things that the 
company might consider doing, for example, restricting the 
distribution of this drug to certain physicians and certain 
pharmacies that are really qualified to dispense this 
prescription?
    Third, adding substances to the drug that would make it 
impossible or reduce its toxicity if it were crushed or taken 
in other--in an adverse manner?
    Mr. Friedman. Well, first of all, I would like to say that 
I can tell you that we will be more aggressive and we will do 
as much as we can to solve the problem.
    Mr. Bass. Can you keep the subcommittee informed as to that 
progress?
    Mr. Friedman. Yes, sir.
    Mr. Bass. Thank you.
    Mr. Friedman. And insofar as the question of what we can do 
about a new--adding substances or making abuse-resistant 
formulations, I might ask Dr. Goldenheim to provide some 
comments.
    Mr. Bass. Before he does, can you address the third issue, 
which is the restriction of sales to people who are really 
outside a general practice or to any--that issue?
    Mr. Friedman. Yes.
    Mr. Bass. I can't think of any other ways to deal with the 
issue.
    Mr. Udell. Restricting sales has been described to us in 
two ways. One is restricting the types of doctors who would use 
these drugs, and the second is restricting certain--
distribution to certain pharmacies. I think, Mr. Bass, you 
alluded to both of those.
    Mr. Bass. Yes.
    Mr. Udell. With respect to the first, it is a terribly 
difficult problem. We understand that there are about 4,000 
pain specialists in the United States. There are vast numbers 
of patients who need drugs, such as OxyContin, who don't have 
access to those doctors. Now, what happens, even in the case of 
cancer patients, who are at the prestigious institutions, 
cancer centers, when they go back home into the community, 
their pain is managed by their family physician. So it is very 
difficult to say you are going to restrict access only to 
specialists, because to do so would be to deprive the vast 
majority of people who need it, of these drugs.
    On the other hand, DEA has said, and we totally agree with 
DEA on this, is that physicians should not use drugs like this 
unless they know how to use them. Whether they are pain 
specialists, or whether they are family physicians, they should 
know how to use them. And the other is a role for us, and it is 
a role that we undertake willingly and happily, and that is, to 
try to help these doctors understand how to use these drugs.
    And the programs that Mr. Greenwood spoke about, programs 
that we have put on, to teach doctors how to use these drugs 
responsibly and appropriately, have been invaluable. And they 
have been directly applicable to solving the problem.
    For example, in the State of Kentucky, when the United 
States Attorney, Mr. Famularo--I saw him on television and he 
had made an arrest of 200-plus people involved in drug trade--
prescription drug trade. I called him in the morning, the very 
next morning, and I said to him, we distribute OxyContin. 
OxyContin played a major role in the large drug bust that I 
read about yesterday. We want to help be a part of the problem. 
How can we help you? And we start--we embarked on a 
conversation of what we can do to help that problem in 
Kentucky. And what was very important to him is this very 
subject--education. He said we have a lot of doctors who don't 
understand how to use these drugs. They need education. Can you 
help us with that? And we did.
    We established a group, together with the United States 
Attorney's Office. He designated an Assistant United States 
Attorney to work with us, and together, we put on programs in 
the community where there was the greatest abuse, to try to 
deal with the problem. And Mr. Famularo, himself, attended 
those programs.
    Even earlier, when we first heard of this problem, the very 
earliest time--it was very interesting that Mr. Woodworth said 
that he knew about it earlier than this and he assumed that we 
did. And that was a surprise to me because Mr. McCloskey, who 
was the United States Attorney in Maine at the time, told me 
that when he started to see that problem, at the very earliest, 
at the beginning of 2000, he reached out to the DEA for 
information and the DEA people with whom he spoke said, they 
don't know of an OxyContin problem. They are unaware of an 
OxyContin problem.
    And that brings us right to the point that was made by the 
District Attorney of Bucks County. I think that she made a 
wonderful point. Cooperation and sharing of information is 
essential. And if some element in the DEA knew there was a 
problem, Mr. McCloskey should have known about it. He is the 
United States Attorney. He should have gotten an affirmative 
response. We should have known about it. And we didn't know 
about it. And we didn't know about it. We knew about it after 
it pulsed up in Maine and the press reported it. And, again, 
the first thing we did was we said, we want to go up and see 
you. We want to meet with you, and we did. And we met with Mr. 
McCloskey.
    And, again, Mr. Bass, in answer to your specific question, 
we acted very quickly. At that meeting, we said to Mr. 
McCloskey, we want to work together with you to solve the 
problem in Washington County, Maine. How can we do it? And what 
we--and what came out of that meeting was, we said to him, we 
call on all the doctors in this community, the doctors who 
write these prescriptions. We can deliver a message to these 
doctors. And, frankly, the message that we want to deliver is 
the same message that you want to deliver. And that is, these 
drugs can be prescribed and dispensed responsibly or not, and 
we want them to be dispensed and prescribed responsibly.
    We can deliver the message. And we said to Mr. McCloskey, 
let us work together to develop a message, to develop a program 
for these doctors. And we did. We developed a brochure, 
together with Mr. McCloskey. Immediately, at that meeting, we 
said, let us start to work our people and your people and 
develop a method of communicating with doctors in this 
community, which is ravaged by abuse of our product, to try to 
solve it. And that meeting, and those discussions, resulted in 
very effective tools, which have been praised by law 
enforcement throughout the country.
    Now, Mr. McCloskey told us that, at that meeting, he 
realized that there were certain resources that law enforcement 
has and there are certain resources that law enforcement does 
not have. And he realized, then and there, something that you 
have heard throughout this hearing--and I think it is a very 
significant thing--and that is, we have to all work together. 
We are willing. We are eager. We want to do our part.
    Mr. McCloskey said that he realized, at the meeting with 
us, that Purdue had resources and skills that law enforcement 
didn't have. And the objective is to pull these together and 
fight the problem. We are here. We have traveled all over the 
country. Mr. Friedman and I have personally visited--these are 
not phone calls--we have personally visited with law 
enforcement people across the country where this is a problem, 
and we have asked one question. Describe your problem to me and 
tell us how we can help to solve the problem. We are very 
sincere on this, Mr. Bass.
    Mr. Bass. Is Dr. Haddox here or is he----
    Mr. Udell. No. He is not.
    Mr. Bass. He is quoted as saying--and this is the other 
issue--that Purdue has been working to reformulate OxyContin.
    Mr. Udell. Yes. I think that----
    Mr. Bass. And then we have another indication that in the 
past, prior to that, the company had stated that reformulation 
was not an option. What has changed? Is this an----
    Mr. Udell. I think that Dr. Goldenheim is really the best 
one to explain that to you.
    Mr. Bass. Fine. Can we have Dr. Goldenheim?
    Mr. Udell. Thank you, sir.
    Dr. Goldenheim. Thank you. Could I just say, by way of a 
preface, that I--as a physician, I am personally very 
distressed by the abuse of our product. It is clearly causing 
devastation. It is clearly also helping an enormous number of 
people. Mr. Chairman, you have made that clear. Other people on 
the panel have made that clear. As a physician, it is very 
distressing that our product, when improperly used, is causing 
such devastation. And, in addition to the methods and actions 
that Mr. Friedman and Mr. Udell describe, we are aggressively 
pursuing reformulation.
    And, if I might very briefly, in 1996, we became aware that 
Hydrocodone--you have heard about that drug earlier today, the 
active narcotic ingredient in Vicodin--was, I think, at the 
time, the most commonly abused narcotic in the United States. 
And we embarked on a program to reformulate that drug because, 
at the time, we were not aware of abuse of OxyContin.
    We started to formulate that drug with an antagonist, with 
a blocker, called Naloxone. Because it was a complicated 
problem, we wanted to get advice from FDA. And we set up a 
meeting with FDA, DEA, and the National Institute of Drug 
Abuse, and that meeting took place in 1997. At that meeting, we 
were informed that the abuse of Vicodin was via the oral route, 
and you have heard a great deal about that today, how, in the 
recent cases with OxyContin, much of the abuse is to crushing 
the tablet and ingesting it.
    We were told that Vicodin was abused orally. As a result, 
we were told and advised not to use Naloxone. The reason very 
simply is that Naloxone will not prevent abuse of a narcotic 
orally. It will prevent the abuse when it is crushed and 
injected. So, as a result of that, we switched to a different 
drug called Naltrexone. The advantage of Naltrexone is that it 
is absorbed orally. But now we have a very difficult problem. 
Because at one in the same time we have to make sure that 
enough is absorbed so that it blocks the high, if you will, so 
that it blocks the abuse potential, yet, at the same time, 
doesn't interfere with the pain relief. So we have got a 
balancing act.
    And this was a much more difficult task, a much more 
difficult hurdle, that was--that we set out for ourselves. And 
we have been working on that very diligently ever since. 
Because if we could succeed in doing this, we could have the 
formulation that would be resistant to oral abuse and 
intravenous abuse and probably also snorting as well.
    In 1998, we had some additional questions, wrote to the 
DEA. And as recently as 1999, DEA wrote to us and again 
reminded us that this was principally a problem of oral abuse. 
It was not until last year, when OxyContin press became so 
prevalent, when we began investigating, when we had this 
meetings that were just described to you, that we learned that 
in addition to the oral abuse, that OxyContin was also, on 
occasion, being crushed and used intravenously. As a result of 
that, we have started on a very intensive program, around the 
first of this year, to formulate it with Naloxone. Again, the 
Naloxone then will help prevent the intravenous abuse, but 
won't do anything to prevent the oral abuse.
    We have worked very closely with FDA on developing a plan 
to meet today's standards for what would be required for such a 
formulation, and we hope, working closely with FDA, to be able 
to make a submission on a product with Naloxone some time next 
year. So we are working on it very, very intensively. The 
Naltrexone, the sort of broader solution, if you will, is more 
complex and will take several years.
    Mr. Bass. Thank you very much, doctor. Thank you, Mr. 
Chairman.
    Mr. Greenwood. Before Mr. Bass leaves, I would ask 
unanimous consent to leave the record open for 10 business days 
for additional opening statements and supplemental materials. 
Without objection, it is so ordered. Mr. Bass does have to 
catch a 4 o'clock train--or plane to Philadelphia. So we are 
going to excuse him and thank you----
    Mr. Bass. Thank you, Mr. Chairman. And thank you all for 
appearing today. You have been very helpful.
    Mr. Greenwood. The Chair recognizes himself for inquiry. 
And let me turn to you, Dr. Levy, if I might. You heard the 
testimony of Ms. Atwood, sitting next to you, about her--about 
a member of her family who had the back pain resulting from an 
automobile accident, was prescribed OxyContin, and then you 
heard her testify about the way in which he rapidly escalated 
the dosage until the issue was no longer alleviating his back 
pain. I don't think he was raising the dosage because the 20 
milligrams wasn't working to relieve his pain anymore. He was 
doing this because of his addiction to the substance, and I 
assume, because of his desire for the rush, if you will, as 
opposed to just trying to get the same amount of relief of his 
pain.
    So could you talk to us about that? Tell us what--how does 
this drug work in that regard? I am somewhat familiar with the 
fact that addictive drugs, like heroin, stop the production of 
normal dopamines, I think the term may be, in the brain and, 
therefore, the addict starts to increase the dosage just to 
maintain a level, an even keel. What is the addictive--what are 
the addictive properties of this drug and how would you account 
for her--Ms. Atwood's family member's experience?
    Mr. Levy. I guess I would say that first we need to have a 
common definition of addiction, which is the compulsive use of 
a substance despite self-harm. We have many patients who have 
full function on long-term doses of OxyContin, no euphoria, no 
addiction, but their body can't be fixed from whatever happened 
to them, whether it is the cancer, the cancer therapy, or an 
incidental thing that occurred to them prior to or after that.
    Mr. Greenwood. Well, let me interrupt you there. Does it--
when you are in a pain maintenance regime, does it tend to be, 
generally speaking, that you can use, keep a relatively 
constant dosage and maintain the palliative effect, but then, 
perhaps, as the pain increases from a worsening cancerous 
condition, you increase the dosage? Is that--you don't need a 
continuously increasing dosage to get the same palliative 
effect?
    Mr. Levy. That is correct. When we are treating patients 
who have opioid-responsive pain--and I think that is the key to 
this--so that we keep them on the same doses for months and 
years. And we have to be careful not to call them addicts any 
more than we call our diabetes addicted to their Insulin.
    What we are seeming to understand about tolerance, that is, 
the need for more and more dose, that whereas that more and 
more dose in our cancer patients is usually because there is 
more and more cancer. There is another receptor, sort of key 
and lock in the spinal cord, that has been studied called the 
NMDA receptor. And that in many chronic pains, either from 
chronic use of opioids, or from the pain emanating from nerve 
damage, these receptors start to increase in their population 
and those pains don't respond well to just opioids.
    And if you keep increasing the opioids, you get to the 
point that you are no longer treating the physical pain. You 
are starting to treat the psychologic and emotional pain, that 
many patients will then--the pain doesn't get any better, but 
they just can take a nap. And there is the patient who starts 
to get in trouble. Because when you are going to those higher 
levels, that is when you are going to need more and more 
Oxycodone.
    What we need is better pain assessment and use of those 
coanalgesics that I mentioned, a variety of medicines that were 
first discovered to help people with depression or seizures or 
heart rhythm problems or the installation of pumps and tubes 
into the spinal cord, that can really help those kinds of pains 
that all the Morphine or Oxycodone in the world won't help.
    So I think the real answer to that is people need to know 
when they need to refer a patient to a comprehensive center 
that can look at all of the modalities, physical, invasive, 
noninvasive, nonopioid, psychological, behavioral. That is the 
best way to prevent the dose of any opioid from going up and 
then causing the psychologic imbalance that then gets people in 
trouble.
    Mr. Greenwood. Well, then help me out here. I can envision 
the regime where your patients with cancer come into your 
center. You monitor their progress. You see them regularly. 
And, as you indicated in your opening statement, not all of 
your patients have cancer. You have other kinds of patients 
suffering from other kinds of pains. And you are monitoring 
that. You are watching that. And I can understand that. And it 
seems like it is less likely you have an abusive situation 
there.
    Another situation that I envision, and I think it comes 
from some of the reading I have done, is somewhere in West 
Virginia somebody was a coal miner and he hurt his back 5 years 
ago, 10 years ago. He always had pain and he has tried various 
things. And his doctor meets a marketing rep from Purdue Pharma 
who says you ought to try OxyContin for some of these people 
who have chronic pain. He prescribes the OxyContin. And there 
maybe--there doesn't necessarily--isn't this constant 
interaction between physician and patient. There is a renewing 
of the prescription, maybe an escalation in the dosage, and the 
next thing you know, you have someone who is in the shape that 
Ms. Atwood's relative was.
    What should the public policy be or what should the medical 
policy be? And what should--what is the drug company's 
responsibility there to try to make sure that lots of the first 
case happens and less of the second case? Let me throw another 
question in there. And that is the question that Mr. Bass asked 
the company--should this product be marketed to pain 
specialists and oncologists and people who are doing what you 
do exclusively, or should it, in fact, be marketed to a small-
town physician who doesn't know much about this kind of regime 
and just writes the prescriptions as they are demanded by the 
patient?
    Mr. Levy. When I was a medical student, I participated in 
putting some patients on a study of a potentially toxic 
medicine for end-stage heart failure. That was in 1976, and 
that medicine was Capoten, which that group of ace inhibitors 
is now the standard for every physician to write for the common 
starting drug of hypertension. So I think there is an evolution 
of practice that the specialist in any field develop a new 
drug, but we clearly can't have every person with high blood 
pressure have to go to a hypertensive specialist or a 
cardiologist to get that kind of medicine.
    So I think we need to have eyes open and all be 
responsible. I think that we spent the last 20 years teaching 
physicians and nurses and pharmacists to listen to their 
patients, ask them about pain, teaching the patients how to 
report their pain, and much of that was funded by many of the 
pharmaceutical companies that are making those Class II 
medicines.
    I think there is another opportunity for the next level of 
education. And some of the brochures that I have seen from 
Purdue Pharma are now alerting these doctors to the signs of 
the side effects, the signs of abuse, the signs of 
inappropriate use. Much like when Tagamet came out, it was the 
best thing since sliced bread, then caused a lot of side 
effects, and then there was appropriate new information. These 
cycles in medicines can be up to 3 to 10 years.
    I think what we need to do is to increase the education of 
all clinicians on appropriate pain assessment. There are--a lot 
of them--clinical education, as sort of looking as pain as a 
disease. Our whole medical model was that pain was a symptom of 
other diseases and that you just simply treat them and the pain 
will go away. And our experience over the decades is we can't 
always do that.
    I think there also is the Federal--there are Federal 
guidelines for State Medical Examiner Boards that talk about--
that I am sure would say that, just what you mentioned, 
casually seeing--you know, giving a new script for the patient, 
but not re-evaluating them every couple of months, would be bad 
medicine. I mean, because we are looking for comfort and 
function. And when I see a patient who needs a rapid increase 
in their medicine, I am thinking, what did I miss? And we need 
all clinicians to think, what is the mechanism of this pain? 
What can we do specifically to deal with the pain, its 
transmission, and to minimize the dose of a non-specific 
opioids to try to optimize comfort and function? And that is an 
education event that could use more and more Federal funding, 
as well as drug company funding.
    Mr. Greenwood. Let me turn to Dr. Jenkins, who has been 
sitting patiently for all of these hours, from the Food and 
Drug Administration. And while the Food and Drug Administration 
has not offered to make an opening statement or offer 
testimony, Dr. Jenkins is kind to come to answer any questions.
    What policy implications might we draw here? I know that 
there has been some discussion about whether or not these--this 
drug can be reformulated to thwart its vulnerability to abuse. 
This is a science that has been around prior to the launch of 
OxyContin. And the question that occurs to me, as a legislator, 
as a policymaker, is should a Class II drug like this, or 
similar drugs that have this potential for abuse and for 
addiction, should this whole question of inhibitors be part of 
the approval process from day one, as opposed to launching a 
very powerful drug like this and then coming back and trying to 
close the barn doors after the horses have left?
    Mr. Jenkins. Thank you, Mr. Chairman. First of all, we do 
not require that the antagonist be added to opioids, at this 
time, for approval. When OxyContin was approved by the FDA in 
1995, it was done with the history of knowing that there were 
other sustained-release narcotics already approved. We have 
heard about MS-Contin. There was another compound called 
Duramorph. These were Morphine products that were sustained-
released products. We had not seen evidence that those were 
subject to widespread abuse and diversion. So at the time that 
OxyContin was approved, it had been shown to be safe and 
effective in clinical trials for treatment of moderate to 
severe pain, and there was no reason, at that time, to suspect 
the type of abuse that we have seen subsequently, and there was 
no reason to consider requiring the addition of an antagonist.
    There are issues that have to be addressed when you think 
about adding an antagonist to a formulation. There are 
sometimes very complicated chemical issues, formulation issues. 
There are complex pharmacology issues. There is also the 
fundamental question that you have to address, that most of the 
patients who are receiving the combination product, don't need 
the antagonist. So they are receiving a drug and being exposed 
to a drug that may have its own side effects that they don't 
need.
    So as a policy, we have not required that opiates contain 
antagonists at the time of approval. That is currently our 
policy. We have been willing to work with companies in 
situations where widespread abuse and diversion have become an 
issue, to address whether adding an antagonist will help to 
address the problem.
    I think it is important, though, that adding Naloxone to 
OxyContin is not going to totally solve this problem. There 
will be potential ways that addicts will find to get around 
that addition. And there are also question that have to be 
addressed to make sure that legitimate patients still get the 
pain relief that they need from the drug and that they are not 
blocked by the antagonist. So it is a very complicated issue.
    Mr. Greenwood. Well, you made reference, Dr. Jenkins, to 
the statutory requirement that the Food and Drug Administration 
must determine that a drug is both safe and effective before it 
approves it for market. And the question that is occurring to 
me--and I was involved in rewriting the Food and Drug 
Administration Act several years ago--is whether for drugs of 
this nature, that have such a potential to be abused, as well 
as, as we must all continue to reiterate, the magnificent 
potential is has to relieve pain, whether there ought to be an 
additional standard that apply--and that is, that these drugs 
be safe when used according to prescription. That they be 
effective when used according to prescription and that all 
practical steps are taken to reduce the likelihood of their 
abuse.
    And it seems to me that a product of this power, a powerful 
drug like this, should, in the future, that perhaps the 
Congress ought to take into consideration adding an additional 
standard. And that is to make sure that the manufacturer and 
the agency think through, in advance, what are the things that 
need to be done in terms of marketing restrictions, if 
necessary, in terms of antagonists, that may or may not be 
appropriate, in terms of education, in terms of thinking 
through who should the prescribers be, and who might the 
prescribers not be. Maybe we need to add that step to this 
process, because I don't think it exists. And, correct me if I 
am wrong, I don't think it really--there is such a rigorous 
process in the ordinary FDA approval process.
    Mr. Jenkins. Actually, Mr. Chairman, there is. We have a 
controlled substances staff in the Center for Drug Evaluation 
and Research, and their responsibility is to evaluate products 
that are going to be scheduled and evaluated abuse liability 
and communicate with the reviewing divisions about steps that 
can----
    Mr. Greenwood. And that happened in the case of OxyContin?
    Mr. Jenkins. I am sure it did. Remembering that Oxycodone, 
the base substance in OxyContin, was already a Schedule II 
narcotic in 1995, when OxyContin was approved. So it was 
already going to be a Schedule II product. Now, we have learned 
from the recent events and we will certainly be applying those 
learnings of what we have seen with the abuse liability for 
sustained-release products like this one to OxyContin and our 
dealings with the company now and also to future products.
    So--but abuse liability is part of what the FDA does when 
we are assessing products as they are being developed. We often 
see products and we have great concerns about the ability of 
those products to be abused and we recommend the changes in the 
formulation or packaging, or, even in vary rare cases, the 
distribution and prescribing patterns for the drug, to try to 
limit that abuse.
    Mr. Greenwood. Ms. Atwood, let me turn to you. You 
described poignantly your family member's experience, having 
been injured in a car accident, taking the drug, and then 
quickly accelerated the dosage and becoming essentially captive 
to its power. You also treat other people who have used and 
abused OxyContin. Can you talk a little bit about the profile 
of those folks? For instance, do you see--have you seen in your 
practice other instances of individuals who began this process 
with a legitimate prescription and followed a course similar to 
the one you described, as well--and to what extent to you see 
that versus people who aren't experiencing pain, don't have a 
legal prescription, but have become addicted to the drug by 
acquiring it on the street?
    Ms. Atwood. Let me start--I kind of want to jump back to 
what you asked Dr. Levy. I think that a lot of times the 
increase in dopamine that you were talking about, in addition 
to the increase in intercellular or extracellular dopamine, 
there is also an increase of indigenous opioids that happen. So 
this is a really powerful thing. And I think that it is very 
sad that to this point you haven't heard about the physiology 
of the addiction. We know how it happens in pain, but we are 
not--it wasn't discussed how it happens in addiction. And I 
think that that is very sad.
    Mr. Greenwood. I am all ears, if you want to get at it.
    Ms. Atwood. Well, I just--I think that the same concern 
that a doctor would take if a patient came in with COPD. And 
knowing the side effect of the respiratory side--the 
respiratory depressant side effect of that, a doctor seeing a 
patient that had COPD would be very cautious----
    Mr. Greenwood. What is COPD? COPD is----
    Ms. Atwood. Chronic obstructive pulmonary disease.
    Mr. Greenwood. Okay.
    Ms. Atwood. A doctor would be very cautious in prescribing 
an opiate because the opiate receptor has three parts to it, 
the euphoria, the analgesic, and the respiratory depressant. So 
if you know you have all three, you would be very cautious in 
prescribing a respiratory depressant to somebody that already 
has a respiratory depressant problem.
    And what occurred to me when you talking to these gentleman 
about the Naltrexone and the--those two antagonists----
    Mr. Greenwood. Antagonists.
    Ms. Atwood. [continuing] that maybe if doctors had the 
time--I know sometimes doctors purposely don't do that, but I 
don't often think that is the case, and I think that an entire 
examination of the health care system as it stands today also 
would be necessary in this discussion. But in any case, I think 
that if we knew that this person was walking in there with a 
history of the disease of addiction that then maybe there could 
be a form of the drug just for them so that we weren't 
medicating people that weren't addicts with the antagonists and 
we were giving addicts that had pain and needed this drug with 
the antagonist.
    Mr. Greenwood. And are you seeing--to the question of the 
street utilization, you are seeing people who have not had any 
prescription whatsoever, not had any history of pain, and who 
acquired this drug on the street as a so-called recreational 
drug and became addicted or just be--what have you seen in that 
regard?
    Ms. Atwood. I would say that most times they have already 
had a chemical dependency predisposition. I have seen--in 
addition to my relative, I have seen 2 or 3 other kids that 
came in and were on it for car-related car accident trauma that 
became addicted. Otherwise, yes, it started out with 
recreational use. And I think that speaks to our society and 
culture.
    Mr. Greenwood. I am going to ask this panel, as I did the 
last panel, if there are any comments or statements or lines of 
dialog that you would like to entertain that you think that we 
haven't elicited with questions yet.
    Mr. Udell. If I may, Mr. Chairman?
    Mr. Greenwood. Yes, certainly.
    Mr. Udell. At the very beginning of the hearing, Mr. 
Chairman, I think you quite correctly pointed out that we are 
facing the problem of prescription drug abuse in the United 
States, that it is a serious problem. And I think that thread 
that should run through this hearing is that we shouldn't focus 
entirely on OxyContin, but we have to focus on the entire 
problem of prescription drug abuse. It is quite understandable 
that much of the time today has focused on OxyContin because 
today, here, that seems to be the principal problem.
    However, what we have seen, even in the experience of 
OxyContin, we have seen this cycle in and cycle out. And the 
example that I will give you of that--that explains that, sir, 
is that at the very beginning of the problem, just after 
Washington County, Maine, where we first observed this problem, 
ground zero was Lee County, Virginia. Bucks County may be 
ground zero today, but, at that time, it was Lee County, 
Virginia. And Michael Friedman and I traveled to Bucks County--
--
    Mr. Friedman. To Lee----
    Mr. Udell. [continuing] to Lee County, Virginia, and we met 
with the sheriff and the Commonwealth attorney. And I said to 
Sheriff Parsons, after I heard the devastation that he 
described--I said to him, sheriff, if OxyContin disappeared 
from Lee County, Virginia, tomorrow, what would things be like? 
And he said to me, Mr. Udell, the people who are abusing 
OxyContin today would go back to abusing the drugs that they 
abused before OxyContin. And what he said has proven to be the 
case, because I spoke with him again just last week and I said 
to him, sheriff, how are things on the streets in Lee County 
today?
    And he said to me, we no longer have an OxyContin problem 
in Lee County. He said, we have arrested the principal doctor 
who was responsible for illegal distribution of it, as has been 
the case in Bucks County. And he said the efforts of law 
enforcement, the cooperation of Purdue Pharma, which provided 
him with placebo tablets, so that he was able to do reverse 
buy-and-bust sting operations--the combined efforts of law 
enforcement, the company, the medical education programs that 
we have done--that we have conducted in that area, has 
eliminated the problem. There is no OxyContin problem on the 
streets in Lee County he told me last week.
    And I said to him, and what is the condition of drug abuse 
in Lee County? And he said, I am very sorry to say that the 
people who were abusing OxyContin are now abusing the other 
drugs--Vicodin, Percocet, Lortab, and so on. And so I think 
is----
    Mr. Greenwood. With equally fatal results?
    Mr. Udell. You know, I have not seen recent autopsy data. 
But I can say, sir, that the entire problem of prescription 
drug abuse is accelerating. And if you look at the chart, which 
is no longer there--if you look at the chart, what we did see 
was that when OxyContin was introduced, up until just last 
year, up until the year 2000, the deaths from Oxycodone-
containing products were the same as they were before. The last 
year before OxyContin was introduced, I saw five deaths in that 
county--five deaths. And up until the year 2000, the number was 
five deaths. So I would submit, sir, that even before there was 
an OxyContin, people were abusing prescription drugs and dying 
from it.
    And that brings me to the second point I would like to 
make. Again and again we heard about education. We have got to 
teach these kids that abusing a prescription drug is as 
significant and as serious as abusing heroin. And we believe 
that, as a company that makes a prescription drug, we have an 
obligation to be a part of that process. And we have done so, 
on our own. We have instituted public service announcements 
directed at teenagers in areas where there is abuse, telling 
them just that.
    Mr. Greenwood. What is your budget for that?
    Mr. Udell. I don't know what we have spent. But I can tell 
you something else we have done, sir. We commissioned an 
organization that specializes in marketing products to 
teenagers and to preteens. And we said to them, assume that the 
product that you want to sell is don't use prescription drugs. 
Come up with a program directed at these teenagers and preteens 
telling them that it is as dangerous to use a prescription drug 
as it is to use heroin. We did that. We developed a program. We 
have carried that program to people who are specialists, to 
people who are experts in communicating things like this to 
young people, and they have applauded it and celebrated it. 
This is something where we stepped up to the plate and we did 
it.
    And we would like very much to make those materials 
available here in Bucks County because we think that materials 
like this can help in Bucks County. We have developed them and 
we would like to make them available here. And I would very 
much like, sir, if someone could tell us who the contacts 
should be here in Bucks County so that we can start to use this 
program to educate kids in this county on the dangers of 
prescription drug abuse.
    The third point, sir, is one that you and I have discussed 
before, and that is prescription monitoring programs. I don't 
think that that has been discussed here, but it really is the 
answer to a lot of the questions that have been asked. When we 
met the last time, you said to me, what is the one thing that 
the Federal Government can do to help this problem? What do you 
think we can do? And my response then is the same response it 
is now, and I know that you agree with this. And that is 
prescription monitoring programs.
    Prescription monitoring programs have proven again and 
again to be highly effective in dealing with the problem of 
diversion of products like this. But there is a role that is 
unique to the Federal Government. And that is, the Federal 
Government can solve the problem that now exists with respect 
to existing prescription monitoring programs. And that is, they 
are a patchwork. They are inconsistent. There are some that are 
horrible. There are some that are pretty good. And we believe, 
and we have supported from inception, from the moment we 
learned about this problem--and I believe we are the only 
pharmaceutical company in the country that supports this--the 
institution of effective prescription monitoring programs.
    And we believe that the Federal Government, that the 
Congress of the United States, can define standards, can set 
standards for prescription monitoring programs, encourage the 
States to implement them. Make them real time so that you don't 
have to wait weeks or months to get the data. Make them real 
time just like when you put your credit card in a restaurant, 
they instantly know whether or not that credit card is good. We 
have that technology and we should use it to solve this 
problem. And we are encouraging States to do that and we fully 
support you, sir, in your efforts to have the Federal 
Government do that as well.
    It is also important that a doctor in State ``A'' can query 
the data base in State ``B'' to find out whether or not his 
patient is going across the State line and buying prescription 
drugs and getting prescriptions in another State. Now, right 
now, the citizens of Pennsylvania--I am sorry--the doctors of 
Pennsylvania would be unable to query a data base in New Jersey 
because--if both States had prescription monitoring programs--
because the State of New Jersey doesn't recognize the authority 
of a doctor in the State of Pennsylvania to do so.
    And similarly, a law enforcement officer. Mr. Demarest, if 
he wanted to find out what was happening across the line in New 
Jersey, and New Jersey had a prescription monitoring program, 
they wouldn't recognize that either. And that goes back again 
to this question of cooperation and sharing of information. And 
I believe there is a very important role for the Federal 
Government in this area, which we fully support, in trying to 
pull all of this together, establish standards and say to the 
States, if you do this, it will help and we will incentivize 
you to do it.
    Mr. Greenwood. And, as a matter--I appreciate that. And, as 
a matter of fact, it is my intention to hold a hearing in the 
relatively near future on that very issue on how we can find an 
appropriate Federal role in prescription monitoring programs 
for the States and how we can add to that.
    Let me ask you three quick questions. Is there any thought 
on the part of your company of moving from the process of 
paying your sales force on a commission basis on--based on the 
volume of sales for this product?
    Mr. Udell. The question of our compensation programs has 
been raised. It was raised early on in the process and we have 
considered it, we have studied it, and we have made some 
changes, in part, in response to suggestions by people in 
government. And we are continuing to look at this.
    As we look at it today--I recently looked at a survey--I 
guess it was last week--our program is consistent with that of 
every other company selling drugs which are more abused than 
OxyContin. And I think that this is something that has to be 
studied by the industry. Now, you know, we can't combine to do 
this because of antitrust considerations. But, on the other 
hand, if we developed a system that was far different from that 
utilized by other companies, it might be a problem in terms of 
attracting qualified people to our company. And I think you are 
correct that these are issues that should be studied by all 
companies in the industry and we are doing so.
    Mr. Greenwood. Have you considered or have you, in fact, 
dedicated some percentage of your profits to rehabilitation of 
your--those who have become addicted to your product?
    Mr. Udell. The question of rehabilitation is an interesting 
one because as we have visited with law enforcement and 
government people, what occurs--what appears to us is that we 
have got to work at the root causes of these problems. The 
people who end up in treatment centers, they need the help. 
They must get the help. But they are the people who have failed 
this--where the system has failed them earlier on. And we think 
that we have got to focus on that.
    We have got to focus on developing abuse-resistant 
formulations so that we don't create--so that people don't 
become addicted to our product. We have got to do the education 
of young people to make sure that they don't abuse this product 
because they think it is just another drug and not as serious 
as heroin. We have got to focus on educating doctors, the way 
we described earlier, to make sure that they understand how to 
produce these--how to use these products properly.
    Those attack the root causes of the problem. And we are 
committed to spending substantial sums of money in that area. 
Research alone is costing us--on abuse-resistant formulations, 
is costing us tens of millions of dollars each year. That is 
just research alone. The development of the other programs I 
have spoken about are also significant.
    The fact that Michael Friedman and Howard Udell and Paul 
Goldenheim are traveling all over the country trying to go to 
areas where there is a problem and say how can we help? We 
care. We are serious. We want to help. That has a cost too 
because we are not available back home to run the business. And 
we are on the road. Michael Friedman and I have been on the 
road constantly since last September when we visited with Mr. 
McCloskey. And that is a cost, as well, sir.
    Mr. Greenwood. Okay. Mr. Levy, did you have a comment you 
wanted to make?
    Mr. Levy. Yes. I think, in summary, I would like to urge a 
note of caution that, you know, simple problems to complex--
simple solutions to complex problems rarely work. And that we 
need to be careful not to demonize Oxycodone or glorify 
Naloxone. Now, you have spoken many times of the sheer potency 
of Oxycodone and it, perhaps, is twice as strong as Morphine, 
but Hydromorphone is four times as strong and Fentanyl is 50 
times as strong.
    So it isn't just the potency. It is the process of how 
these medicines are used and how they then get abused. Studies 
in cancer patients have documented in tens of thousands of 
patients that we do not create addicts by medical prescribing. 
And the several studies have been done in this country and in 
Europe when we look at addicts in chronic noncancer pain 
patients, like the patient, you know, with the car accident. 
The same percent of the normal population that has substance 
abuse, 6 to 10 percent, is that number in those who are in pain 
clinics.
    So we have to do this professionally. We have to, you know, 
fix the problem, not the blame. We need to recognize that it 
isn't that simple scientifically. There is not just three types 
of things. There are, at least, 10 opioid receptors. And so it 
is not that easy to jump and find a magic bullet as much as we 
would like it. Attempts at mixed drugs, like Talwin, which 
were--and Nubain, which were part agonist, part antagonist, 
showed that they had a ceiling, they didn't relieve severe 
pain, and they caused different side effects that made them 
worse than pure opioids so that the Agency for Healthcare 
Policy and Research says do not use them.
    So we need to have a note of caution. We need, I agree, as 
everyone else has said, to work together. We need to not allow 
inference to creep in, such as the comment of having conversion 
guidelines from Darvocet or Codeine to Oxycodone. That is 
because those drugs don't work. And if we didn't tell the 
physicians how to get the patient on the right dose of Morphine 
or Oxycodone, we had a patient staying in pain.
    So I think we need to go down to the consensus that we all 
have, that we want to help patients, help our society. We 
unfortunately live in a society that condones abuse. Our 
society abuses alcohol, tobacco, food, and fast cars. They all 
are killers. We need to have a rational public policy approach 
that helps get the right medicine to the right people and the 
right education to the right people. I don't think that 
OxyContin is any more lethal than any other medicine. I think 
because of things that have been discussed, it is 
accessibility, that kids don't know that what color is what 
milligrams. And that is why, I think, we have seen more deaths 
from OxyContin than we have seen--you know, recently than we 
have seen from Hydromorphone or Fentanyl.
    So I think we need to keep it in perspective. We need to 
look at our whole culture. And I hope we all have an 
opportunity to work on a process together, with education and 
monitoring, with appropriate resources so that we can really 
get both of these epidemics under control.
    Mr. Greenwood. Thank you. Ms. Atwood, any final comments?
    Ms. Atwood. I would like to, first of all, thank you very 
much for inviting me to be here. I think that any discussion 
that has to do with addiction and drugs of abuse and so forth, 
I think that the underutilization of the recovery community as 
a resource and as an assistance in educating and preventing and 
policing and treatment, that we are very highly effective, as 
well as cost effective, resource for all of you to use. And I 
wish that you would let us be available to you.
    Mr. Greenwood. Thank you. Mr. Jenkins?
    Mr. Jenkins. I would just like to thank you for allowing us 
to be here today. We do take this problem very seriously and we 
are going to do all we can, from our perspective, to try to 
address this problem.
    Mr. Greenwood. Well, thank you, all. This committee has a 
responsibility to put issues like this under the microscope to 
ask the tough questions. And we also have the responsibility 
though, as legislators, to be part of the solution. And, as I 
said, we will be looking into the issue of how we can do the 
monitoring and how we can find Federal policy issues so that we 
can, in fact, work with the manufacturers, work with the abuse 
treatment community, work with evaluative community, and the 
FDA to make sure that in this product and similar products 
society gets to reap the benefit and minimize the anguish.
    Thank you all again. I want to thank, again, Mayor Joe 
DiGirolamo for generously allowing the Congress to use the 
public meeting room. I also want to again thank his Executive 
Assistant, Ms. Barbara Barnes, for coordinating with my staff 
on this. And, finally, Mr. Ralph Douglas, the Chairman of the 
Bensalem Cable Advisory Board who has volunteered to spend all 
of his time here covering this broadcast and taping it for the 
township. And thank you all once again. Thank you, audience, 
for participating. And this hearing is adjourned.
    [Whereupon, at 3:12 p.m., the subcommittee was adjourned.]
    [Additional materiial submitted for the record follows:]
                 Prepared Statement of Edward J. Bisch
    I would like to thank the members of the committee for allowing my 
voice to be heard. My name is Edward Bisch from Philadelphia PA., On 
Presidents day of this year. February 19, 2001 I received a call that 
all parents DREAD and pray they NEVER receive. Christi my 15 year old 
daughter could not wake her brother ``Eddie'' up. That was the first 
day I ever heard the word OXYCONTIN. I was shocked when a police 
officer came in the house and said Oxycontin, ``kids are dying left and 
right from this''? I could NOT believe what I was hearing and angrily 
yelled? WHY DID I NEVER HEAR OR WAS WARNED ABOUT THIS DRUG?
    From that moment on I started to educate myself on Oxycontin and 
started warning as many people as I could about the devastation of 
abusing it. My family and I quickly decided to publicly AIR our dirty 
laundry about Eddie's death to get the word out to as many people as 
possible about OXYCONTIN ABUSE. We notified the MEDIA and were more 
appalled when the Philadelphia Daily News reported OXYCONTIN was also 
involved in 20 Philadelphia deaths within a three month period, but no 
warning was given about this rising epidemic?
    We called a community meeting and my sister called all the media 
outlets in the City, to help us get the word to the Philadelphia region 
about the DEADLY abuse of this drug. The media responded that night and 
all the TV, Newspaper and News radio stations reported on the 
Previously unpublicized killer.
    I myself personally started a CHAIN email to also help warn people 
here and throughout the country. The email then evolved into a website 
(oxyABUSEkills.com) and now the website has evolved into a Nonprofit 
organization called the PDAAP (Prescription Drug Abuse Awareness & 
Prevention). All this is in loving Memory of my son Eddie Bisch.
    Needless to say this has devastated my family and particularly 
Eddie's Mom who has had several breakdowns trying to deal with this 
terrible and shocking tragedy.
    I commend this board for helping US bring awareness to this still 
rising problem.
    Since Eddie's death most of my free time has been spent either 
researching or working to spread the word about OXY abuse. I have also 
talked to hundreds of people all over the country through my website 
from Government Agents, politicians, doctors, abusers, reporters, 
informers, grieving relatives of other victims, drug companies, cancer 
patients. and Chronic pain patients. Oxyabusekills.com has had over 
30,000 visitors. I also volunteer and talk at schools and community 
groups about OXY abuse. If there is such a thing, I would consider 
myself an UNWILLING expert on OXY ABUSE.
    I have learned that this is a complicated and history making 
situation due to the fact that people in Severe Chronic Pain really do 
need this drug and I am totally against BANNING it but I personally 
feel it should ONLY be used for SEVERE PAIN because it is a very 
powerful pain killer and it is too easy to FAKE moderate pain which 
contributes to the diversion problem. Now that this ABUSE EPIDEMIC is 
being acknowledged the question is how do we slow or stop this ABUSE 
epidemic?
    Winning this battle is not going to be easy, it will take the 
combined efforts of the public, government, doctors, patients and 
Manufacturer (PurduePharma) which has already started some education 
programs.
    I'd like to publicly suggest the following:

1) We need to identify and Prosecute doctor shoppers and publicize this 
        to let others know the FREE RIDE is over. For too long Police 
        have looked the other way or have not allocated enough 
        resources to stop this crime. Computerized monitoring is the 
        best way to do this BUT we need to get this speedily 
        implemented and all 50 states need it.
2) It should NOT take 9 months to Arrest Crooked Doctors or Pharmacists 
        who have been identified. Dr. Paolino of Bensalem PA. was able 
        to put around 300,000 pills on the street while under 
        investigation? This delay should be investigated and If this is 
        the NORMAL system then something needs to be changed to speed 
        it up.
3) Training should be readily available and REQUIRED for any doctor who 
        writes prescriptions for oxycontin. There are not enough Pain 
        Management Specialist to limit the prescribing to them but a 
        shorter course should be REQUIRED for any doctor who writes a 
        prescription for this powerful pain killer.
4) Doctors should be legally required to explain tolerance/dependence 
        to people. I have received MANY emails from legitimate patients 
        who were not explained anything except take twice daily, Many 
        of these legitimate patients eventually became abusers.
5) Legitimate patients who resell part of their prescription need to be 
        made aware that this is DRUG DEALING, people are DYING and this 
        NO LONGER will be overlooked. This is another crime law 
        enforcement has overlooked for too long.
6) Treatment needs to be readily available so a person who wants help 
        can have it immediately. the deaths are getting the headlines 
        but there are MANY more already addicted. If treatment is not 
        available then when the OXY supply does start to dry up, MANY 
        OXY abusers will turn to heroin.
7) Finally, Continue to educate everyone, especially teens on the 
        dangers of Abusing Prescription Drugs.
    As you have heard in previous testimony that Most OXY related 
deaths also involved other drugs including alcohol and Eddie was part 
of this majority as early the day before he died, he had abused another 
prescription drug XANAX.
    I realize it was Prescription Drug Abuse that killed Eddie, but OXY 
is the straw that is breaking the camel's back in most of these 
death's, not to mention how many more are now addicted to it. 
Government agencies have documented that PILL POPPING is rapidly rising 
among teenagers. This is why we have founded the PDAAP, to develop 
programs to educate the teens on how DANGEROUS/ADDICTIVE it is to Abuse 
pills. I somehow would like to be a partner/volunteer to this committee 
to help educate the children, to at least give them a fighting chance. 
To properly warn them of the consequences when they choose to abuse 
pills. This is the 21st century with 21st century drugs and we NEED 
21st century drug education programs.
    Thank you and I will help in anyway I can and ANYONE at anytime can 
contact me through my website oxyABUSEkills.com. WARN ABOUT OXY ABUSE 
to ENSURE ACCESS FOR PROPER USE.
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