| Text of
Printed Hearing The Committee on Energy and Commerce W.J. "Billy" Tauzin, Chairman "OxyContin: Its Use and Abuse." <DOC>
[107th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:75754.wais]
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
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512-1800
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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<SUP>'</SUP>. 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<SUP>'</SUP>, 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<SUP>'</SUP> 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<SUP>'</SUP> 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<SUP>'</SUP>. 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<SUP>'</SUP> to abusers. While OxyContin<SUP>'</SUP> 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<SUP>'</SUP>, including the State of
Pennsylvania.
The appeal of OxyContin<SUP>'</SUP> 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<SUP>'</SUP> 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<SUP>'</SUP>, nor to prevent practitioners acting in the usual
course of their medical practice from prescribing OxyContin<SUP>'</SUP>
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<SUP>'</SUP> 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<SUP>'</SUP>'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<SUP>'</SUP> 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<SUP>'</SUP>, as well as the feasibility of
reformulating OxyContin<SUP>'</SUP> in order to reduce its abuse
potential. On August 8, 2001, the company announced the development of
a reformulated version of OxyContin<SUP>'</SUP>. 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<SUP>'</SUP> prescriptions all
have long standing prescription monitoring programs in place. These
five states, beginning with the fewest per capita prescriptions for
OxyContin<SUP>'</SUP> 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<SUP>'</SUP> 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<SUP>'</SUP> 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<SUP>'</SUP>.
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:
<bullet> A doctor who fraudulently prescribes OxyContin to abusers for
money.
<bullet> A pharmacist who illegally fills an abuser's prescription, or
who forges prescriptions for abusers.
<bullet> Abusers who steal prescription pads, and then write their own
forged prescriptions.
<bullet> 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:
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> 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.
<bullet> 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.
<bullet> 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
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