[Senate Hearing 107-287]
[From the U.S. Government Publishing Office]
S. Hrg. 107-287
OXYCONTIN: BALANCING RISKS AND BENEFITS
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
ON
EXAMINING THE EFFECTS OF THE PAINKILLER OXYCONTIN, FOCUSING ON FEDERAL,
STATE AND LOCAL EFFORTS TO DECREASE ABUSE AND MISUSE OF THIS PRODUCT
WHILE ASSURING AVAILABILITY FOR PATIENTS WHO SUFFER DAILY FROM CHRONIC
MODERATE TO SEVERE PAIN
__________
FEBRUARY 12, 2002
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
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WASHINGTON : 2002
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut JUDD GREGG, New Hampshire
TOM HARKIN, Iowa BILL FRIST, Tennessee
BARBARA A. MIKULSKI, Maryland MICHAEL B. ENZI, Wyoming
JAMES M. JEFFORDS (I), Vermont TIM HUTCHINSON, Arkansas
JEFF BINGAMAN, New Mexico JOHN W. WARNER, Virginia
PAUL D. WELLSTONE, Minnesota CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington PAT ROBERTS, Kansas
JACK REED, Rhode Island SUSAN M. COLLINS, Maine
JOHN EDWARDS, North Carolina JEFF SESSIONS, Alabama
HILLARY RODHAM CLINTON, New York MIKE DeWINE, Ohio
J. Michael Myers, Staff Director and Chief Counsel
Townsend Lange McNitt, Minority Staff Director
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(ii)
C O N T E N T S
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STATEMENTS
TUESDAY, FEBRUARY 12, 2002
Page
Reed, Hon. Jack, a U.S. Senator from the State of Rhode Island,
opening statement.............................................. 1
Warner, Hon. John W., a U.S. Senator from the State of Virginia,
opening statement.............................................. 4
Clinton, Hon. Hillary Rodham, a U.S. Senator from the State of
New York, opening statement.................................... 6
Collins, Hon. Susan M., a U.S. Senator from the State of Maine,
opening statement.............................................. 8
Dodd, Hon. Christopher J., a U.S. Senator from the State of
Connecticut, opening statement................................. 10
Jenkins, Dr. John K., Director, Office of New Drugs, Center for
Drug Evaluation and Research, Food and Drug Administration,
Rockville, MD; Dr. H. Westley Clark, M.P.H, J.D., Director,
Center for Substance Abuse Treatment, Substance Abuse and
Mental Health Services Administration, Rockville, MD........... 13
Prepared statements of:......................................
Dr. Jenkins.............................................. 14
Dr. Clark................................................ 24
Payne, Dr. Richard, Chief, Pain and Palliative Care Service,
Department of Neurology, Memorial Sloan-Kettering Cancer
Center, New York, NY; Dr. Art Van Zee, Lee Coalition for
Health, St. Charles, VA; Nancy Green, C.N.M., President,
Neighbors Against Drug Abuse, Calais, ME; Lieutenant William R.
Bess, J.D., Drug Enforcement Division, Virginia State Police,
Wytheville, VA; and Dr. Paul D. Goldenheim, Vice President for
Research, Purdue Pharma, L.P., Stamford, CT.................... 40
Prepared statements of:......................................
Dr. Payne................................................ 42
Dr. Van Zee.............................................. 46
Ms. Green................................................ 61
Lt. Bess................................................. 66
Dr. Goldenheim........................................... 70
ADDITIONAL MATERIAL
Articles, publications, letters, etc.:
Response from the Department of Health & Human Services to
questions asked of Dr. John Jenkins by Senator Reed........ 18
Response from the Department of Health & Human Services to a
question asked of Dr. John Jenkins by Senator Collins...... 19
Response from Dr. Goldenheim to a question asked by Senator
Reed....................................................... 81
American Pharmaceutical Association (APhA)................... 96
Charlene Cowley (ASPMN)...................................... 97
National Association of Chain Drug Stores (NACDS)............ 98
National Institute on Drug Abuse (NIDA)...................... 100
Carlos Ortiz on Behalf of CVS Pharmacy....................... 101
American Academy of Family Physicians (AAFP)................. 103
Russell K. Portenoy, M.D..................................... 105
(iii)
OXYCONTIN: BALANCING RISKS AND BENEFITS
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TUESDAY, FEBRUARY 12, 2002
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 2:34 p.m., in
room SD-430, Dirksen Senate Office Building, Hon. Jack Reed,
presiding.
Present: Senators Reed, Dodd, Clinton, Warner and Collins.
Opening Statement of Senator Reed
Senator Reed. Good afternoon. Let me call this hearing to
order and make an opening statement and recognize my colleagues
prior to calling the first panel.
I am very pleased this afternoon to chair this full
committee hearing of the Senate Health, Education, Labor, and
Pensions Committee on OxyContin. OxyContin is a synthetic,
time-release pain medication containing oxycodone, which is an
opiod similar to morphine. OxyContin is manufactured by Purdue
Pharma and was approved by the Food and Drug Administration in
December 1995 to aid cancer patients and people with moderate
to severe pain who require around-the-clock opiods for an
extended time. While this medication has revolutionized pain
management for thousands of Americans, OxyContin, like other
Schedule II narcotics, has a high potential for abuse and
sadly, that potential for abuse has become a reality in too
many cases.
OxyContin abusers have discovered that if the tablets are
broken, the time release mechanism of the drug is broken,
enabling the abuser to achieve a euphoric, heroin-like high. In
this form, and if taken with alcohol or other drugs, OxyContin
is extremely dangerous. No one predicted the level of diversion
and abuse that would become the legacy of this drug.
I would like to thank all of our witnesses who will be
appearing this afternoon. This afternoon we will hear from Dr.
John K. Jenkins, director, Office of New Drugs at the Food and
Drug Administration, and Dr. H. Westley Clark, Director of the
Center for Substance Abuse Treatment at SAMHSA.
On our second panel we will have Dr. Richard Payne, Chief
of Pain and Palliative Care Services at Memorial Sloan-
Kettering Cancer Center in New York; Dr. Art Van Zee of the Lee
Coalition for Health in St. Charles, VA; Ms. Nancy Green, a
Certified Nurse-Midwife and President of Neighbors Against Drug
Abuse in Calais, ME; Lieutenant William R. Bess of the Drug
Enforcement Division of the Virginia State Police; and Dr. Paul
D. Goldenheim, Vice President for Research, Purdue Pharma,
L.P., the manufacturer of OxyContin.
Last October, a Drug Enforcement Agency report on autopsy
data revealed that there was evidence to suggest that OxyContin
played a role in the overdose deaths of 282 people over a 19-
month period. Most of those deaths also involved other drugs
and alcohol.
In addition, OxyContin has been associated with an
increasing wave of pharmacy robberies and other violent crimes,
particularly in rural areas. OxyContin diversion and abuse has
become rampant in rural parts of Maine, Tennessee, Kentucky,
Virginia and Massachusetts. While the trend in OxyContin abuse
originated in more rural areas, it is now beginning to make its
way to urban centers along the Eastern seaboard. Indeed, there
have even been armed robberies of pharmacies in my home State
of Rhode Island.
While these trends are certainly cause for alarm, we must
also consider the importance of OxyContin for those who suffer
moderate to severe chronic pain. For many Americans OxyContin
has meant the difference between total incapacitation from pain
and being able to return to a semblance of normal life.
Numerous studies show that pain management in this country is
far from ideal. Many physicians, in fact, tend to undertreat
pain for many reasons. A 2000 end-of-life study by Brown
University Associate Professor, Dr. Joan Teno, based on
interviews with bereaved families of nursing home residents
reported that half of those patients experienced pain at end-
of-life while two-thirds of those families rated the pain as
severe more than half the time. Indeed, we have a lot of work
to do with respect to the management of pain and we have to
recognize that OxyContin is an important part of that
management regime in some cases.
During today's hearing I hope we can gain a better
understanding of the promotion and marketing practices of
OxyContin and whether or not these activities have contributed
to the extensive abuse of this drug and whether or not Federal
agencies responsible for approving narcotics require additional
authority in light of these new challenges. We will gain an
insight into the devastation that illegal use of this drug has
caused in many rural parts of America and how those areas are
working to fight back. I also hope we will learn why OxyContin
is considered to be a significant advancement in the treatment
of pain, as well.
I look forward to the testimony of all our witnesses and
thank you again for attending this afternoon's hearing.
Prior to recognizing my colleagues, let me also submit for
the record a statement from Senator Bunning, who could not be
here but would like his statement included.
[The prepared statement of Senator Bunning follows:]
Prepared Statement of Senator Bunning
Good afternoon, Mr. Chairman and Members of the Committee.
I appreciate the Committee's willingness to hold a hearing on
this very important issue before us today.
OxyContin was approved by the Food and Drug Administration
in 1995 and has been celebrated as a ``miracle drug'' for
people who suffer from chronic pain and patients with terminal
cancer. OxyContin, is a controlled substance, like morphine and
other intense pain relievers, and has been found to have a high
potential for abuse. It is supplied in a controlled-release
dosage form and is intended to provide up to 12 hours of relief
from severe pain. The tablet must be taken whole and orally.
However, when crushed in can be snorted or diluted to be
injected where then the drug produces an intense high which
many users say is equal to, or even better than, heroin.
Therefore, it is as well, highly addictive.
The illegal use and sale of OxyContin has risen
dramatically throughout the nation, but nowhere as prominently
as in the rural areas of the eastern United States. While the
problem has been most heavily documented in Appalachia,
criminal cases are popping up at alarming rates all across the
United States.
In Eastern Kentucky, the illegal use of the drug has risen
to epidemic proportions. After nearly an eight-month
investigation, details started to emerge in early February 2001
of an elaborate multi-state ``pipeline'' that ran from Greater
Cincinnati to the mountain communities in Eastern Kentucky.
During a raid in Eastern Kentucky, Federal agents and local
police arrested over 200 people ranging in age from 20 to 65
for the abuse of OxyContin. This drug has torn families apart,
ruined lives, and stretched the resources of law enforcement
and social service agencies to its limit.
Using pharmacists and doctors in several states, suppliers
are evading a computerized watchdog system in Kentucky known as
KASPER (Kentucky All-Schedule Prescription Electronic Reporting
system) and successfully slipping thousands of the pills into
Eastern Kentucky where many residents are wrestling with
OxyContin addictions. Data from the Kentucky Cabinet for Health
Services shows there were 82,880 prescriptions filled for the
drug in 1999. In 2000, the total prescriptions filled almost
doubled and jumped to 156,660. This is not only amazing, but is
frightening.
It has been alleged that Purdue Pharma, the producer of
OxyContin, has marketed the drug excessively without stressing
its addictive nature. In testimony before the House
Appropriations Committee's Commerce, Justice, State and
Judiciary Subcommittee, the Drug Enforcement Administration
said that Purdue Pharma had contributed to its
``disproportionate abuse'' by aggressively marketing it as less
prone to abuse than similar drugs.
My Kentucky colleague in the House of Representatives,
Congressmen Hal Rogers recently requested that the General
Accounting Office (GAO) investigate the marketing of the
prescription drug OxyContin. I am anxiously awaiting GAO's
study with the hopes that its findings will present Congress
with some alternatives and justifications to help stem the
abuse of this ``miracle drug.'' While I certainly do not want
to see this ``miracle drug'' prohibited from being
manufactured, marketed and prescribed. I do, do however, want
to ensure that if there are abusive marketing, distribution and
prescription practices, that they be ended to make our families
stronger and communities safer.
The abuse of this drug is literally ripping apart families
and communities in Eastern Kentucky. The OxyContin addiction is
so strong in some areas that some are beginning to prostitute
themselves to pay for their addiction to the drug. Burglaries
and robberies are up in Appalachian Kentucky, and law
enforcement point the finger at OxyContin addiction. These
problems are not just relative to Kentucky, but all across the
nation the abuse of this addictive drug has turned good people
into drug dealers and addicts, and some communities have been
turned into places where neighbors and acquaintances are feared
because of OxyContin.
I appreciate this Committee taking the time to take a look
at this problem. It is not a problem that is going to go away
quickly, but I hope from this and other hearings we can find
some solutions to stem the abuse and addiction of OxyContin.
Thank you, Mr. Chairman.
Senator Reed. At this time, I would like to call upon
Senator Warner for his opening comments.
Senator Warner. I thank you, Mr. Chairman. Might I yield to
my colleague?
Senator Collins. Go right ahead. Thank you.
Opening Statement of Senator Warner
Senator Warner. Well, thank you, Mr. Chairman.
Mr. Chairman, may I commend you on a very thorough and
carefully prepared opening statement. A great deal of the
material that you have covered I had intended to use in my
statement so I think I will just file my statement for the
record.
[The prepared statement of Senator Warner follows:]
Prepared Statement of Senator Warner
Mr. Chairman and Senator Gregg, thank you for scheduling
this important hearing today on the risks and benefits of
OxyContin.
As you may recall, in July of last year, I wrote and spoke
to you both about the emerging problem of OxyContin abuse, and
I was the first United States Senator to ask for a Senate
hearing on this matter.
Senator Kennedy and Senator Gregg--you both have been
responsive in scheduling this hearing at my request, along with
Senator Collins' request. Today's hearing had been previously
scheduled a number of times but was repeatedly postponed due to
the events of September 11th and the days that followed. I
thank you both for your diligence in scheduling this hearing
today.
I also would like to welcome two Virginians who are with us
today to testify before the Committee.
First, I am pleased that we are joined today by Dr. Art Van
Zee of Lee County, Virginia. Last year, I had the pleasure of
meeting with Dr. Van Zee to hear his views about OxyContin
during one of my visits to the St. Charles Community Health
Center in St. Charles, Virginia. I look forward to hearing his
testimony today.
In addition, I would like to welcome Lieutenant William
Bess of the Virginia State Police. While I have not had the
pleasure of meeting with Lieutenant Bess before today, I have
had a number of discussions about OxyContin abuse with the
Virginia State Police, and I look forward to receiving an
update on law enforcement's experience with OxyContin in
Virginia.
Given that southwest Virginia has been effected
disproportionately by illegal use and abuse of OxyContin, I am
particularly grateful that two Virginians who are so familiar
with this issue are here to share their expertise with the
Committee. I thank you both in advance for your testimony
today.
The importance of the issues before this Committee today
cannot be overstated.
In OxyContin, we have a prescription drug that was hailed
as a miracle pain reliever for chronic pain when it first
became available to patients in the mid 1990s. Indeed,
OxyContin serves an important function for many Americans who
are suffering from chronic pain.
On the other hand, the very fact that OxyContin is so
effective at relieving pain also makes it a target for abuse.
In Virginia alone, it is estimated that there have been over 55
deaths linked to OxyContin.
While OxyContin is a relatively new drug and OxyContin
abuse is a newer phenomena, the issues surrounding OxyContin
have been well documented in the media.
The New York Times Magazine did a feature article on its
cover called, ``The OxyContin Underground: How a Prescription
Painkiller is Turning into a Pernicious Street Drug.
Newsweek's cover in April of 2001 contained a featured
article highlighted on its cover called, ``Painkillers: Vicodin
and OxyContin: Hot Drugs That Offer Relief--And Danger.''
And, the front page of the USA Today on August 9, 2001 ,
contained a cover story on opiods, including OxyContin.
These are just a few of the many articles that I have read
about OxyContin.
In addition, I have taken the initiative to meet with
experts all across Virginia to examine the benefits and risks
of OxyContin.
The facts are simple, and I am sure we will hear them
today. This drug has a lot of benefits when prescribed by a
doctor and taken in accordance with the prescription. However,
this miracle drug is also being abused, has led to increased
crime, and has been linked to deaths not just in Virginia, but
across the United States, particularly in rural Appalachia.
Accordingly, I look forward to the testimony today,
particularly testimony about how this Committee can be helpful
in curbing OxyContin abuse.
1 thank my Chairman once again for calling this hearing.
After today's hearing, I imagine that some of us on this
Committee will sit down and determine how the Federal
Government can be more helpful in efforts to stem OxyContin
abuse. I look forward to working on this issue with my
colleagues.
Senator Warner. Mr. Chairman, I am the son of a doctor. If
I had had half the brains of my father, a distinguished serving
gynecologist, I would have been in the medical profession but I
came up a little short and here I am. But I have taken a
particular interest throughout my now 24 years in the U.S.
Senate regarding those issues which are related to medicine and
also law enforcement. I spent my early years in life as an
assistant U.S. Attorney and this, to me, is one of the most
complex that I have ever seen.
We are privileged to have a number of people here from
Virginia who will testify. There are others, like my good
friend the Church family back here who have labored tirelessly
with the United Mine Workers for many years and this problem is
very prevalent in Southwest Virginia on up through the Roanoke
Valley. But, as the chairman mentioned in his own State, here
it is in Northern Virginia, four robberies here in the last few
weeks.
Now I wish to say, speaking for myself, that we are not
going to leap to legislation. What we have to do is to
encourage the responsible partners--the medical profession
where, as you say, this drug is essential to relieving pain. My
father devoted much of his life to cancer and that is one of
the primary uses of this product. Indeed, the law enforcement
have got a major role, to explain what it is about this
particular drug that has induced so many to perform crimes and
then oftentimes become addicts themselves. The treatment of
those who either legally or illegally get possession of this
drug and use it without the careful guidance of the physician.
So there are many parties, in my judgment, that have to
work with us before the Congress can move on the question of
legislation.
So I thank the chair and my colleagues on this committee
for joining with me today and I thank you. Yes, I was among the
first to ask for this hearing. After traveling my State and
holding a number of town meetings on this subject I felt it was
urgent for the U.S. Senate to devote its attention and I thank
the chair.
Senator Reed. Thank you, Senator Warner.
Senator Clinton, do you have an opening statement?
Opening Statement of Senator Clinton
Senator Clinton. Thank you very much, Senator Reed. I join
my colleague, Senator Warner, in thanking you for holding this
important hearing. And I think it is important not only because
of the particular issues that have already been addressed and
the particular drug that brings us here but also because we
generally face a significant drug abuse problem and
particularly a prescription drug abuse problem that does not
quite get the attention that it deserves because of the human
cost it entails.
I believe that you have put together an excellent series of
witnesses. I am going to have to excuse myself. I am not going
to be able to hear all the panels but I particularly wanted to
thank Dr. Richard Payne, chief of Pain and Palliative Care
Services at Memorial Sloan-Kettering Cancer Center in New York
for being here because one of the purposes of this hearing is
to educate the public about prescription drug abuse, to work
with the medical professions represented to determine how best
they can have more control over the prescription drugs that are
so central to the legitimate purposes in medicine. For example,
we should be looking at prescription monitoring programs, which
constitute an information tool that doctors can use to protect
themselves from drug-seekers and doctor-shoppers.
But I also think we have to take a hard look at what
particular specific problems are arising out of OxyContin in
and of itself. I agree completely with Senator Warner that we
have to go at this in a very careful and thoughtful way because
on the other side of the ledger I worry about the people who do
suffer from cancer and other very painful diseases and
conditions for whom this drug is literally a life-saver because
of the way that it can relieve their pain.
You know, the Institute of Medicine issued a June 2001
report concluding that people with cancer, including children,
suffer great pain and much of that pain, even at the end of
life, is often ignored or treated less than successfully and
many, many people who are themselves patients feel concern
about what they should or should not accept from their
physicians in terms of relieving pain.
So this whole question of pain relief is one that I hope we
will also get into more directly through this hearing and other
hearings. I am concerned, for example, that one out of every 10
women undergoing radical mastectomies reported chronic pain but
often that was just chalked up to psychological anguish. And
finally, a study in the 1980s showed that the surgical
technique for radical mastectomy was often severing a major
thoracic nerve in women and the technique was reversed, but the
fact that women had complained about this and the intense pain,
even though it was in the context of an amputation, was not
really understood for quite some time.
So I think we have to deal with the scourge of prescription
drug abuse with the kind of break-ins and robberies that are
unfortunately all too common, particularly in the rural areas
of our State. At the same time we have to look for ways to
provide the kind of palliative care that prescription drug
developments certainly can do.
When New York developed a tracking system for
tranquilizers, emergency rooms in New York and Buffalo reported
47 percent fewer tranquilizer overdose admissions. So there are
some techniques that have been found to work and I would like
to look at ways to minimize the adverse health consequences for
legitimate patients.
Even in New York, though, where we saw a dramatic success,
there were also reports that physicians, fearful of legal
reprisals, substituted tranquilizers that were not tracked,
often which had difficult and more complicated potential side
effects, than the monitored drugs. So we clearly have a problem
here and it goes beyond this particular drug.
I am also concerned about inappropriate prescription drug
marketing and promotion. The other night watching the Olympics
with my husband, a drug advertisement came on and it has
beautiful pictures and the text referred to some side effects
and then in little, little tiny print it had some additional
information about some potential adverse effects. I do not
think that that is appropriate. Advertising should provide
accurate information, not misleading impressions. And I hope
that we can also begin to address this issue.
And finally, Mr. Chairman, we need in general in our
country more education about pain. It is a problem that leads
to both underprescribing and overprescribing. And I think, in
part, we have not paid enough attention. We have not done
enough research. We have not educated ourselves adequately to
really understand pain. We have a lot of people who are caught
up in this OxyContin abuse who started out as legitimate users
and then fell into the abyss of being dependent and addicted
and maybe if we understood pain better in the first place we
could also avoid some of those questions.
So these are among the many issues that this excellent
hearing raises for us, Mr. Chairman, and I thank you for
convening us.
Senator Reed. Thank you very much, Senator Clinton.
Senator Collins?
Opening Statement of Senator Collins
Senator Collins. Thank you, Mr. Chairman.
I want to begin by thanking Senator Reed for agreeing to
chair this hearing, which Senator Warner and I jointly
requested a few months ago in response to extremely troubling
developments in drug abuse in our States.
We are here today to examine the benefits and the risks of
a legal but regulated narcotic pill marketed under the name of
OxyContin. We will hear compelling testimony today that this
drug, when used properly, has benefited thousands of
individuals by relieving their suffering and improving the
quality of their lives. There are many people who have a
legitimate medical need for OxyContin and we cannot forget that
in some cases this drug has made a real difference in the
quality of their lives.
On the other hand, we will also learn today that OxyContin,
diverted from its legitimate purpose to control pain, has
instead created untold pain and suffering in communities like
those in Washington County, Maine. I am very sad to say that
the State of Maine was among the first places in the Nation to
experience an epidemic of OxyContin abuse. It was not long
after the first press report about OxyContin abuse in the
Bangor Daily News in April of 2000 that other State and
national media began documenting the effects of OxyContin on
several other rural communities across the country.
One of the features that makes OxyContin so attractive to
elicit users is that the time release mechanism can be defeated
by simply crushing or dissolving the tablets, creating an
effect similar to heroin. The drug can then be snorted or
injected, with a number of tragic consequences, including
addiction, criminal activity to support the addiction,
involvement in other dangerous drugs such as heroin, hepatitis
C and HIV infection, and, of course, overdose and even death.
It is important to acknowledge that the abuse of
prescription drugs has long been a significant national
problem. It is estimated that 4 million Americans abuse
prescription drugs. The use and abuse of prescription
medications have more than a $100 billion impact on our
Nation's health care costs.
It would be disingenuous, however, to dismiss the current
epidemic of OxyContin abuse as simply the latest drug of
choice, no different from last year's or perhaps next year's
popular drug. The testimony this afternoon will highlight how
OxyContin has insinuated itself into communities and, as one
Maine law enforcement officer has described it, spread like
wildfire. Indeed, yesterday afternoon I was talking with our
witness from Maine and we talked about the number of addicts
living in Washington County, which is a rural, beautiful but
very economically disadvantaged part of my State.
Washington County has a population of only about 35,000
citizens. It is estimated by law enforcement officials that
1,000 of those citizens are addicted. That is just a startling
statistic.
The first step toward any solution, of course, is to
understand the problem and that is why I am so pleased that an
outstanding community leader, Nancy Green, is here with us
today to help us understand the problem in Washington County,
Maine and, by extension, the problem that faces communities
across the Nation. She serves on the front lines in her
practice as a certified nurse-midwife helping pregnant women
who are also OxyContin addicts. In another part of my
conversation with her yesterday afternoon she described the
addicted babies that she has been delivering.
In her testimony she will describe how the affliction of
OxyContin abuse has affected her own community of Calais, ME.
This affliction has been termed Maine's latest and newest
epidemic. A brief recitation of some of the more appalling
statistics about the situation in my State certainly supports
that conclusion. For example, during the last 5 years
Washington County has experienced an 800 percent increase in
arrests related to the sale or possession of narcotics. The
county sheriff attributes fully 50 percent of the increase in
personal and property crimes to the abuse of OxyContin and
other prescription drugs.
Admissions to substance abuse treatments for opiates,
including OxyContin, have increased by 500 percent in the State
of Maine since 1995, the year that OxyContin was first
introduced. Admissions in Washington County alone have
increased by 1,600 percent and I would tell you that it is not
as if there are a lot of treatment facilities available to help
people struggling with addiction.
A recent report issued last month by the Maine Substance
Abuse Services Commission reported that opium addicts have gone
from constituting 2 percent of the treatment population in 1995
to making up 12 percent of the treatment population in 2001.
This is an unprecedented change.
Mr. Chairman, I would ask that a copy of this full report
be included in the hearing record.
Senator Reed. Without objection.
[The report follows:]
(The report was not available at press time, however, a
copy is maintained in the Committee files.)
Senator Collins. These statistics, however shocking, do not
fully convey the destruction of human lives caused by the abuse
of OxyContin. When talking to people on the front lines in
Maine I have heard stories of lost jobs, broken families, and
young people who naively thought that a legal drug available at
a local pharmacy could not possibly do them any real harm but
who are now in a desperate fight to reclaim their lives.
The devastation spawned by OxyContin abuse in rural Maine,
Virginia and other States has persuaded some people, including
at least one of our witnesses, to call for the removal of the
drug from the market. I respect their views but I have yet to
be persuaded that the solution is that simple for removing
OxyContin from the market would deprive some people of access
to a drug that does indeed provide relief from severe pain. But
in talking with people from Maine I have been convinced that we
need a comprehensive approach that includes prevention,
education, training for physicians, substance abuse treatment
programs, and assistance to law enforcement and I look forward
to exploring all of those issues with our witnesses.
One final point that I want to explore includes the
circumstances surrounding the marketing of OxyContin by its
manufacturer and its rise to becoming the 18th best selling
prescription drug in the country and the number one opiate
painkiller. Serious questions have been raised about Purdue
Pharma's marketing of OxyContin and its education of physicians
and thus the ability of some physicians to properly prescribe
the drug. This issue prompts still further questions about
whether additional Federal and State regulation and monitoring
is needed.
The answers to these questions cannot erase the damage
already done by OxyContin abuse to far too many people in my
State and throughout the country but let us not forget that
other powerful drugs, some of them in development now, may
become the OxyContin of the future if we do not learn from the
lessons of the past couple of years and act on them today.
Again I look forward to hearing our witnesses and thank you
again, Senator Reed, for chairing this important hearing.
Senator Reed. Thank you, Senator Collins.
Senator Dodd, do you have an opening statement?
Opening Statement of Senator Dodd
Senator Dodd. Thank you, Mr. Chairman. I apologize for
arriving a few minutes late for the hearing but I want to thank
you, as well, for holding it and I am looking forward to
hearing the testimony today. The drug OxyContin, by so many
accounts, has become vital to people suffering from chronic and
debilitating pain and stories of addiction and devastation
obviously in States like Maine and other places are obviously
very real and deserve our attention.
As the director of Helen and Harry Gray Cancer Center at
Hartford Hospital in Connecticut has pointed out, drugs like
OxyContin have allowed patients, and I quote, ``patients
suffering from chronic pain to have their lives back.'' So this
is both a drug that causes problems but also has been the
source of some real relief for people.
We are here today because of the growing number of
individuals suffering from the addiction to powerful
painkillers like OxyContin and the rising number of those
preying upon this tragedy by diverting and selling prescription
medications for illegal use. We are here today because of the
millions of Americans suffering from debilitating pain who
deserve the right, in my view, to have access to the most
effective treatment. The abuse and diversion of OxyContin has
tragically led to fatalities among abusers and it has also
deterred patients who could truly benefit from the drug from
taking it because of a fear that is not unfounded.
All of us agree that the alarming stories of abuse of
OxyContin and the resulting addiction and destruction demand an
immediate and aggressive response and, Mr. Chairman, you are
holding this hearing in response to that. Because the response
must be a coordinated effort between targeted law enforcement
and comprehensive substance abuse treatment, I am glad that we
will hear from both Dr. Clark from the Substance Abuse and
Mental Health Services Administration and Lieutenant Bess of
the Drug Enforcement Division of the Virginia State Police, and
our colleague from Virginia I am sure has already made
reference to that.
Addiction destroys lives. We all know that. It destroys
families, destroys neighborhoods. There is no doubt that the
tragedy of drug addiction is exacerbated in communities across
our country by poverty and a lack of opportunity and, as many
have pointed out, our work to stem the tide of addiction must
be accompanied by economic revitalization in these communities.
I am glad that we will also have a chance to hear from
Purdue Pharma, the manufacturer of OxyContin, which is based in
my home State of Connecticut. The company has taken some
important steps since reports of abuse problems from OxyContin
first began to surface to battle the misuse and diversion of
their product. They are educating doctors and pharmacists in
abuse and diversion prevention in coordination with the DEA,
providing placebos and law enforcement sting operations,
working with the FDA to craft stronger warnings on the drug's
label, and pursuing development of a new abuse-resistant dosage
form.
Purdue is clearly willing to participate in an effort to
curtail the diversion and misuse of their product and I urge
them to continue to do so. I hope that today's hearing and
subsequent discussions will generate even more strategies, Mr.
Chairman, for all the interested parties here to implement.
Some have suggested that the abuse of OxyContin is related
to the aggressive marketing and promotion by the company. Last
December Representative Frank Wolf, who chaired a hearing on
this topic before a House Appropriations subcommittee requested
a General Accounting Office study of Purdue's marketing
techniques. Because the Federal Government has an important
responsibility to monitor drug advertising and promotion in the
interest of public health, we should carefully consider the
quality and effect of Purdue's marketing.
In addition, we should look at the relationships between
marketing and the abuse or misuse of a drug. While the
prescribed and legal use of OxyContin has increased
significantly since its introduction in the marketplace in 1996
as a result of manufacturer promotion and the effectiveness of
the medicine, questions remain about the link between marketing
and illicit use or diversion of the drug. In fact, in January
of 2002 a Federal judge in Kentucky wrote that the plaintiffs
in a motion to impose restrictions on the access to OxyContin
had ``failed to produce any evidence showing that the
defendant's marketing, promotional or distributional practices
have ever caused even one tablet of OxyContin to be
inappropriately prescribed or diverted.''
Because this issue is so critical to developing strategies
for preventing abuse of a highly addictive prescription
medication, I intend to ask the General Accounting Office to
broaden their study to look at the entire class of medicines
subject to abuse and diversion and to report on whether there
is evidence of a link between marketing practices of a
manufacturer and increased misuse and diversion. I think that
information, Mr. Chairman, could be of value to this committee,
so we are not just looking at one product but a variety of
them, as well.
So I appreciate the participation of all the witnesses and
am anxious to hear what they have to say and raise some
questions at the appropriate time. I thank you for holding the
hearing.
Senator Reed. Thank you, Senator Dodd.
I would now like to call Dr. John Jenkins and Dr. H.
Westley Clark to please come forward.
Senator Warner. Mr. Chairman, if I could----
Senator Reed. Senator Warner?
Senator Warner. I think we have had very good opening
statements and what strikes me is the localization of this
problem in just certain areas within my State, within your
State, yet how serious they are in those localities. And if we
do not get a responsible response to this issue that could
spread like wildfire across the United States and become a
national catastrophe. So I think it is important that we have
this landmark hearing here in the Senate.
Senator Reed. Thank you very much, Senator Warner. I want
to also thank you and Senator Collins for your efforts. Without
your insistence, this hearing would not be taking place and we
appreciate that effort and commitment.
Let me introduce our first panel. Dr. John Jenkins is
currently the director of the Office of New Drugs, Center for
Drug Evaluation and Research at the Food and Drug
Administration. Dr. Jenkins began his distinguished medical
career in 1983, training in internal medicine, pulmonary and
critical care at Virginia Commonwealth University and the
Medical College of Virginia, where he subsequently served as an
assistant professor of pulmonary and critical care medicine. He
later served as medical director of the lung transplant program
at the McGuire VA Medical Center and medical officer of the
Division of Oncology and Pulmonary Drug Products at FDA. He has
also served as a pulmonary medical group leader and director of
pulmonary drug products and director of the Office of Drug
Evaluation II before being appointed to his current position.
Thank you very much, Dr. Jenkins, for joining us today.
Dr. H. Westley Clark, welcome. Dr. Clark is someone who has
enjoyed a long and esteemed career in the field of substance
abuse. He currently serves as the director of the Center for
Substance Abuse Treatment at the Substance Abuse and Mental
Health Services Administration under the United States
Department of Health and Human Services.
In addition to obtaining his medical degree, he has a
masters in public health, as well as his juris doctorate. Dr.
Clark completed a two-year substance abuse fellowship at the
Department of Veterans Affairs Medical Center in San Francisco,
where he later served as the chief of Associated Substance
Abuse Programs.
He was a senior program consultant to the Robert Wood
Johnson Substance Abuse Policy Program, as well as co-
investigator on a number of National Institute on Drug Abuse-
funded research grants and has served as associate clinical
professor of psychiatry at the University of California at San
Francisco. Dr. Clark, welcome.
Dr. Jenkins and Dr. Clark, your full statements will be
made part of the record so feel free to summarize your
comments, as you consider appropriate. We want to go ahead and
make sure that all the witnesses have ample time to present
their testimony this afternoon.
Dr. Jenkins, if you would begin, please.
STATEMENTS OF JOHN K. JENKINS, M.D., DIRECTOR, OFFICE OF NEW
DRUGS, CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG
ADMINISTRATION, ROCKVILLE, MD; AND WESTLEY H. CLARK, M.D.,
M.P.H, J.D., DIRECTOR, CENTER FOR SUBSTANCE ABUSE TREATMENT,
SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION,
ROCKVILLE, MD
Dr. Jenkins. Thank you, Mr. Chairman. And I will try to be
brief, since many of the things I had planned to say have
already been said by members of the panel.
Senator Reed. Now you know how we feel.
Dr. Jenkins. I appreciate the opportunity to meet with you
today to talk about the drug OxyContin and to explain FDA's
actions in response to the recent reports of abuse, misuse and
illegal diversion of this drug. I can assure you, Mr. Chairman,
that FDA has taken these reports very seriously and we have
responded to these reports with aggressive actions.
Over the past year FDA has worked closely with Purdue
Pharma to strengthen the warnings and precautions sections of
the product labeling regarding the serious and potentially
fatal risk of abuse and misuse of this product. The labeling
has also been changed to emphasize that OxyContin is only
approved by FDA for treatment of moderate to severe pain in
patients who require around-the-clock narcotics for an extended
period of time. Finally, FDA has been working closely in
partnership with the Drug Enforcement Administration, SAMHSA
and other Federal agencies to address this problem of abuse,
misuse and illegal diversion.
In the next few minutes I would like to give you a brief
overview of OxyContin and summarize FDA's activities in
response to the reports of abuse of this drug. I would also
like to briefly touch on FDA's activities related to regulation
of the promotion and marketing of OxyContin.
As has been noted already, OxyContin is a narcotic drug
that was approved by FDA in 1995 for treatment of moderate to
severe pain. It contains oxycodone, which is a narcotic that
has an abuse and addiction potential similar to that of
morphine. OxyContin is formulated in a sustained release
mechanism that allows release of oxycodone in a slow and steady
manner following oral ingestion to provide up to 12 hours of
relief from pain. If the tablet is crushed, however, as has
been noted already, the controlled release mechanism is
defeated, resulting in the immediate release of the entire
OxyContin dose. Ingestion, snorting or intravenous injection of
the resulting powder can result in a fatal overdose in some
situations.
At the time of approval, FDA determined that the benefits
of OxyContin outweighed its risk when used to treat moderate to
severe pain. At the time of approval, FDA also considered the
abuse potential of OxyContin and determined that its abuse
potential was similar to that of other Schedule II narcotics
and we did not foresee the widespread abuse and misuse of
OxyContin that has been reported in the past few years. Despite
these troubling reports, however, FDA continues to believe that
the benefits of OxyContin outweigh its risks when the drug is
used according to the approved labeling.
In July of last year Purdue Pharma, working in cooperation
with FDA, significantly strengthened the warnings and
precautions in the labeling for OxyContin. The labeling for
OxyContin now includes a black box warning, which is the
strongest warning for an FDA-approved product. This boxed
warning alerts patients and physicians to the potentially
lethal consequences of crushing the controlled release tablets.
Purdue Pharma sent a ``Dear Health Care Professional'' letter
to thousands of physicians and other health care professionals
to alert them to these important new warnings.
Furthermore, the labeling for OxyContin now makes clear
that it is only approved by FDA for treatment of moderate to
severe pain in patients who require around-the-clock narcotics
for an extended period of time. And finally, a patient
instruction sheet which provides information to assist patients
in the proper use of OxyContin was recently added to the
labeling.
Now let me briefly discuss issues related to the
advertising and promotion of OxyContin, an issue that several
of you have raised in your opening statements.
First, FDA is not aware of any direct-to-the-consumer
marketing or advertising of OxyContin. As far as FDA is aware,
all advertising and marketing for OxyContin has been directed
only to health care professionals and has generally been in
compliance with FDA regulations.
In May of 2000, however, FDA did send a letter to Purdue
Pharma regarding a medical journal advertisement that promoted
OxyContin in a manner that FDA considered to be inappropriate.
Purdue Pharma agreed to cease dissemination of that
advertisement and the matter was considered to be resolved.
In conclusion, Mr. Chairman, FDA believes that OxyContin is
a valuable product for the treatment of moderate to severe pain
when it is used according to the approved labeling. FDA is
continuing to work closely with Purdue Pharma to take
appropriate actions to curb the abuse and misuse of OxyContin
and we are committed to continuing to work with SAMHSA and our
other Federal agency partners in an effort to address this
serious public health issue. Thank you and I would be happy to
take any questions.
Senator Reed. Thank you very much, Dr. Jenkins.
[The prepared statement of Dr. Jenkins follows:]
Prepared Statement of John K. Jenkins, M.D.
Introduction
Mr. Chairman and Members of the Committee, I am John K. Jenkins,
M.D., Director, Office of New Drugs, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration (FDA or the Agency). I
appreciate the opportunity to talk about the drug OxyContin and the
steps that FDA has taken in an effort to decrease abuse and misuse of
this product while assuring that this drug is used properly and remains
available for patients who suffer daily from chronic moderate to severe
pain.
Let me assure you that the Agency has taken reports of abuse and
misuse of OxyContin very seriously and we have implemented aggressive
steps in response to these reports. FDA has worked closely with the
manufacturer of OxyContin, Purdue Pharma L.P., to strengthen the
warnings and precautions sections of the approved labeling for
OxyContin in order to educate physicians, other healthcare
professionals, and patients regarding the serious, and potentially
fatal, risks of abuse and misuse of this product. FDA has also worked
with Purdue Pharma to modify the approved labeling for OxyContin to
emphasize that it is approved for the treatment of moderate to severe
pain in patients who require around-the-clock narcotics for an extended
period of time. FDA also has worked closely with the Drug Enforcement
Administration (DEA) to address their concerns regarding abuse, misuse,
and illegal diversion of OxyContin.
In order to help you to better understand FDA's actions, I would
like to give you a brief overview of the process FDA followed in
approving OxyContin and FDA's activities related to regulation of the
promotion and marketing of OxyContin.
Background
OxyContin is a narcotic drug that was approved by FDA for the
treatment of moderate to severe pain on December 12, 1995. OxyContin
contains oxycodone HCI, an opioid agonist with an addiction potential
similar to that of morphine. Opioid agonists are substances that act by
attaching to specific proteins called opioid receptors, which are found
in the brain, spinal cord, and gastrointestinal tract. When these drugs
attach to certain opioid receptors in the brain and spinal cord they
can effectively block the transmission of pain messages to the brain.
OxyContin is formulated to release oxycodone HCI in a slow and steady
manner following oral ingestion. OxyContin is the only currently
marketed FDA approved controlled-release formulation of oxycodone. The
drug substance oxycodone, however, has been marketed in the U.S. for
many decades and is available in a wide variety of immediate release
and combination dosage forms.
Oxycodone, like morphine and other opioid agonists, has a high
potential for abuse. OxyContin was specifically developed as a
controlled release formulation by Purdue Pharma to allow for up to 12
hours of relief from moderate to severe pain. This dosage form allows
patients with chronic moderate to severe pain to have their pain
controlled for long periods of time without the need for another dose
of medication and significantly reduces the number of tablets the
patient must take each day.
When used properly, the OxyContin tablet must be taken whole and
only by mouth. If the tablet is crushed, the controlled-release
mechanism is defeated and the oxycodone contained in the tablet is all
released at once. If the contents of an OxyContin tablet are injected
intravenously or snorted into the nostrils a potentially lethal dose of
oxycodone is released immediately. The risk of death due to abuse of
OxyContin in this manner is particularly high in individuals who are
not tolerant to opioids.
Oxycodone, the active ingredient in OxyContin, is a controlled
substance in Schedule II of the Controlled Substances Act (CSA), 21
U.S.C. Sec. 801 et seq., which is administered by the DEA. Schedule II
provides the maximum amount of control possible under the CSA for
approved drug products. Schedule I drugs are considered to have no
recognized medical purpose and are illegal in the U.S. outside of FDA
approved research.
FDA Drug Approval Process
Before any drug is approved for marketing in the U.S., FDA must
decide--as quickly as a thorough evaluation allows--whether the studies
submitted by the drug's sponsor (usually the manufacturer) have
adequately demonstrated that the drug is safe and effective under the
conditions of use in the drug's labeling. It is important to realize;
however, that no drug is absolutely safe. There is always some risk of
adverse reactions with drugs. FDA's approval decisions, therefore,
always involve an assessment of the benefits and the risks for a
particular product. When the benefits of a drug are thought to outweigh
the risks, and if the labeling instructions allow for safe and
effective use, FDA considers a drug safe for approval and marketing.
OxyContin was reviewed by FDA and was approved for treatment of
moderate to severe pain based on two clinical trials that demonstrated
that it was safe and effective for this use. Prior to approval, FDA
evaluated the benefits and risks of use of OxyContin for treatment of
moderate to severe pain and determined that the drug was appropriate
for use in this population when used according to the approved
labeling.
During the approval process of OxyContin, as with all drugs that
are active in the brain, FDA assessed its potential for abuse and
misuse. Abuse liability assessments are based on a composite profile of
the drug's chemistry, pharmacology, clinical manifestations, similarity
to other drugs in a class, and the potential for public health risks
following introduction of the drug to the general population. At the
time of approval, the abuse potential for OxyContin was considered by
FDA to be no greater than for other Schedule II opioid analgesics that
were already marketed in the U.S. Based on. the information available
to FDA at the time of its approval, including the record of other
modified release Schedule II opioids, the widespread abuse and misuse
of OxyContin that has been reported over the past few years was not
predicted. In fact, at the time of its approval, FDA believed that the
controlled-release characteristics of the OxyContin formulation would
result in less abuse potential since, when taken properly, the drug
would be absorbed slowly and there would not be an immediate ``rush''
or high that would promote abuse. In part, FDA based its judgment of
the abuse potential for OxyContin on the prior marketing history of MS-
Contin, a controlled-release formulation of morphine that had been
marketed in the U.S. by Purdue Pharma without significant reports of
abuse and misuse for many years. At the time of OxyContin's approval,
FDA was aware that crushing the controlled-release tablet followed by
intravenous injection of the tablet's contents could result in a lethal
overdose. A warning against such practice was included in the approved
labeling. FDA did not anticipate, however, nor did anyone suggest, that
crushing the controlled-release capsule followed by intravenous
injection or snorting would become widespread and lead to a high level
of abuse.
FDA Actions
Labeling Changes
In July 2001, Purdue Pharma, working in cooperation with FDA,
significantly strengthened the warnings and precautions sections in the
labeling for OxyContin. The labeling for Oxycontin now includes a
``black box'' warning, the strongest warning for an FDA approved
product, which warns patients and physicians of the potentially lethal
consequences of crushing the controlled release tablets and injecting
or snorting the contents. The indication for use was clarified to
reflect that it is approved for the treatment of moderate to severe
pain in patients who require around the clock narcotics for an extended
period of time.
To help in the effort to curb abuse and misuse of OxyContin, FDA
has worked with Purdue Pharma to implement other specific changes in
the OxyContin labeling. The new labeling is intended to highlight to
physicians, other health care professionals, and patients that
OxyContin should be used for the treatment of moderate to severe pain
in patients who require around the clock narcotics for an extended
period of time. As part of the labeling changes, a patient instruction
sheet was added, which contains information to assist patients in the
proper use of OxyContin. These labeling changes are an effort to
educate pharmacists, other health professionals, and the general public
regarding just how important it is to use this drug properly. The new
warnings 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.
FDA has developed a patient-information page on its website
www.fda.gov/cder/drug/infopage/oxycontin/default.htm). This site
provides important information to patients regarding how to safely use
OxyContin, urges patients to keep their supply of OxyContin in a secure
location, and instructs patients to destroy unneeded tablets.
As part of a longer-term strategy to address the current reports of
abuse and misuse of OxyContin, Purdue Pharma has informed FDA that the
company is working to reformulate OxyContin. The reformulation would
add an opioid antagonist that would counteract the effects of
oxycodone, the active ingredient in OxyContin, if the OxyContin tablet
were crushed into a powder and injected or snorted. FDA is working
actively with Purdue Pharma to evaluate the safety and effectiveness of
such a reformulated product. It must be noted that such a reformulation
is not a simple task and it could be several years before any new
combination product is developed, tested in clinical trials, and
approved by FDA. It also must be noted that the addition of the opioid
antagonist to OxyContin to deter abuse means that legitimate patients
would be exposed to a drug substance that they do not need. This could
result in adverse reactions in such legitimate patients. These
potential safety issues, and assurance that the combination tablet
retains its effectiveness in treating moderate to severe pain, must be
a part of FDA's review of a reformulated OxyContin product.
Letters to Health Care Professionals
There have been numerous reports of OxyContin diversion and abuse
in several states. Some of these reported cases have been associated
with serious consequences including death. In an effort to educate
health care providers about these risks, Purdue Pharma has issued a
warning in the form of a ``Dear Healthcare Professional'' letter. The
``Dear Healthcare Professional'' letter was distributed widely to
physicians, pharmacists, and other health professionals. The letter
explains the changes to the labeling, including proper prescribing
information and highlights the problems associated with the abuse and
diversion of OxyContin.
FDA approved indication for OxyContin is for the treatment of
patients with moderate to severe pain who require around-the-clock
opioids for an extended time. An important factor that must be
considered in prescribing OxyContin is the severity-of the pain that is
being treated, not simply the disease causing the painful symptoms.
FDA continues to recommend that appropriate pain control be
provided to patients who are living with moderate to severe pain.
Although abuse, misuse, and diversion are potential problems for all
opioids, including OxyContin, they are a very important part of the
medical armamentarium for the management of pain when used
appropriately under the careful supervision of a physician.
Meeting With Other Government Agencies and Industry
FDA has met with DEA, the Substance Abuse and Mental Health
Services Administration, the National Institute on Drug Abuse, the
Office of National Drug Control Policy, the Centers for Disease Control
and Prevention and Purdue Pharma, and continue to work collaboratively
sharing information and insights needed to address the problem of
OxyContin abuse and diversion.
Millions of Americans suffer from some form of chronic pain. The
pain can be debilitating and often prevents those afflicted from
working or even leaving their home. Many medications, including
opioids, play an important role in the treatment of chronic pain.
Opioids, however, often have their use limited by concerns regarding
misuse, addiction, and possible diversion for non-medical uses. The use
of opioid therapy in some patients has shown extraordinary promise,
enabling some to return to work and to lead a normal life again. FDA is
committed to continuing to work with other government agencies and
sponsors to insure that options are available to patients with chronic
moderate to severe pain, so that in consultation with their personal
physician they can achieve as normal a life as possible.
Advisory Committee Meetings
An FDA advisory committee, a group of non-Agency experts, held a
meeting on January 30-31, 2002, to discuss the medical use of opioid
analgesics, appropriate drug development plans to support approval of
opioid analgesics, and strategies to communicate and manage the risks
associated with opioid analgesics, particularly the risks of abuse of
these drugs. Committee members agreed that opioids are essential for
relieving pain and that a great deal of progress has been made within
the last few years to remove the stigma associated with opioid
treatment. Members suggested that a balanced approach should be taken
to relieve pain for patients and to prevent diversion. They noted that
imposing restrictions on use of opioids could have substantial
likelihood of hurting legitimate patients and reversing the tremendous
progress that has been achieved in the appropriate treatment of pain.
FDA will continue to monitor reports of abuse, misuse, and
diversion of OxyContin and other opioids and will work with other
Federal agencies and drug manufacturers to help ensure that these
important drugs remain available to appropriate patients.
Drug Advertising
FDA has regulated the advertising of prescription drugs since 1962,
under the Food, Drug, and Cosmetic (FD&C) Act and its implementing
regulations. The Division of Drug Marketing, Advertising, and
Communications (DDMAC), in CDER, is responsible for regulating
prescription drug advertising and promotion. DDMAC's mission is to
protect the public health by insuring that prescription drug
information is truthful, balanced, and accurately communicated. This is
accomplished through a comprehensive surveillance, enforcement, and
education program, and by fostering optimal communication of labeling
and promotional information to both health care professionals and
consumers.
FDA regulates prescription drug advertisements and other
promotional materials (called ``promotional labeling'') disseminated by
or on behalf of the advertised product's manufacturer, packer or
distributor to health care professionals and consumers.
Title 21 of the Code of Federal Regulations (21 CFR
Sec. 314.81(b)(3)(i)) requires that advertisements and promotional
labeling be submitted to FDA at the time of initial dissemination
(labeling) and initial publication (advertisements); a post-marketing
submission requirement. The FD&C Act generally prohibits FDA from
requiring that advertisements be approved prior to their use (see
Sec. 502(n)). In other words, FDA's review of promotional materials is
generally intended to occur post hoc--once the materials have already
appeared in public. Accordingly, any FDA enforcement action that FDA
takes is post hoc as well. Most of FDA's enforcement actions request
that sponsors stop using the violative materials. In some cases, FDA
also asks sponsors to run corrective advertisements or issue corrective
letters to remedy inaccurate product impressions created by false or
misleading materials.
FDA is not aware of any direct-to-consumer advertising for
OxyContin. There is nothing in the FD&C Act to prohibit such
advertising. The advertising and marketing for OxyContin has been
directed only to health care professionals. It should be noted that the
current approved product labeling for OxyContin contains a ``black
box'' warning. Boxed warnings are used in labeling to convey serious
risks associated with the use of the drug product. The promotional
materials of drug products with boxed warnings must present these
serious risks in a prominent manner. DDMAC sent a letter to Purdue
Pharma dated May 11, 2000, regarding a journal advertisement that
appeared in the New England Journal of Medicine that promoted OxyContin
in a manner that was false or misleading. Specifically, the
advertisement implied OxyContin had been studied in all types of
arthritis and can be used as first-line therapy for the treatment of
osteoarthritis, failed to include important limitations to claims
presented from an osteoarthritis study; and promoted OxyContin in a
selected class of patients without presenting risk information
especially applicable to that selected class of patients. Purdue Pharma
agreed to cease dissemination of this advertisement and this matter was
resolved with the cooperation of the sponsor.
Conclusion
The Agency recognizes OxyContin as a valuable product when used
properly. We need to do all we can to ensure that the prescriptions get
to the appropriate patients and that labeling and promotion are
appropriate for the product. FDA is working closely with the
manufacturer to take appropriate action to curb the misuse and abuse of
OxyContin. In addition, FDA is involved in the strong interagency
effort to address this issue and we are aware we cannot solve this
problem by ourselves.
We share the Committee's interest and concerns regarding this drug
and would be happy to answer any questions.
response from the department of health and human services to questions
asked of dr. john jenkins by senator reed
Department of Health and Human Services,
Rockville, MD 20857,
March 7, 2002.
Hon. Edward M. Kennedy,
U.S. Senate,
Washington, D.C. 20510-6300.
Dear Mr. Chairman: This letter is in follow-up to the Committee's
February 12, 2002, hearing on balancing the risks and benefits of the
drug OxyContin. Senator Jack Reed posed two questions to Dr. John
Jenkins, Director, Office of New Drugs, Center for Drug Evaluation and
Research, Food and Drug Administration (FDA or the Agency) for the
public record. We have restated the questions and provided answers
below.
Question 1. Would the abuse potential of a drug that is the subject
of an investigational drug application ever be a reason for FDA's
deciding that the drug is not safe and effective? That is, would the
abuse potential of a drug, and the level of harm that the drug can do
when it is abused, ever outweigh the benefits provided by proper use of
the drug?
Answer 1. The decision to approve or not approve a drug is based on
the demonstration of efficacy and safety of the drug in the population
intended for use of the drug. In the situation where an investigational
drug has been shown to be safe and effective for the intended use but
is considered to have a significant potential for misuse, FDA would
consider implementing a strategy, in cooperation with the sponsor, to
effectively manage this risk. Such a risk management strategy could be
put into place in the form of a voluntary agreement with the sponsor
regarding the distribution and/or marketing of the product, or may be
required by FDA as a condition of approval. The Agency has used this
approach to manage the risk of misuse of opiates and would consider
utilizing similar strategies in the future for other drugs that are
subject to misuse.
Question 2. It seemed that all of the panelists agreed that
patients who use OxyContin appropriately rarely become addicted to the
drug. How many times would someone need to use or how much OxyContin
would someone have to use to start on the way to becoming addicted?
Answer 2. There is an important distinction to be made between
physical dependence and addiction to an opioid drug. In the case of
physical dependence, with regular dosing over the course of several
weeks, evidence of physical dependence can be seen. This is a natural
phenomenon, which in general leads to no untoward consequences. In
fact, once these individuals no longer require treatment with the
opioid, they suffer no residual physical effects and do not crave the
effects of the drug. Along with physical dependence, comes tolerance to
the effects of the drug, so that the patient may require higher doses
over time to achieve the same level of pain control. These natural
effects, however, also occur in the addicted patient.
Addiction, as distinguished from physical dependence, is not a
normal condition, but rather one with a complex set of contributing
etiologies that leads to abnormal craving for the drug to the extent
that the addict is willing to commit crimes and engage in self-
destructive behaviors in order to obtain the drug. The contribution of
physical dependence and tolerance add to the exaggerated drug craving
from which the addict is unable to break free. In the case of an
addict, it may take only one or two doses to launch back into the cycle
of addictive behavior. Whereas in the case of a patient who does not
have this addictive propensity, addiction will not occur even after
years of treatment.
Thank you again for your interest in this matter. If you have
further questions, please let us know.
Sincerely,
Melinda K. Plaisier,
Associate Commissioner for Legislation.
______
response from the department of health and human services to a question
asked of dr. john jenkins by senator collins
Department of Health & Human Services,
Rockville, MD 20857,
March 12, 2002.
Hon. Edward M. Kennedy,
U.S. Senate,
Washington, D.C. 20510-6300.
Dear Mr. Chairman: Thank you for the opportunity that was provided
to Dr. John Jenkins, Director, Office of New Drugs, Center for Drug
Evaluation and Research, Food and Drug Administration (FDA or the
Agency), to testify before your committee on February 12, 2002,
regarding balancing the risks and benefits of the drug OxyContin.
During the hearing, Senator Susan M. Collins asked if FDA had ever
sent a warning letter to Purdue Pharma, the manufacturer of OxyContin,
for the drug MS Contin. Dr. Jenkins offered to provide that information
for the record.
FDA's Division of Drug Marketing, Advertising, and Communications
did issue a warning letter to Purdue Pharma on its promotion of MS
Contin on November 20, 1996, for making unsubstantiated comparative
claims for MS Contin over other opioid products for cancer pain.
Although it was a warning letter, the violations did not raise serious
health concerns. A copy of the warning letter is enclosed.
Thank you for making this a part of the public record. If you have
further questions, please let us know.
Sincerely,
Melinda K. Plaisier,
Associate Commissioner for Legislation.
______
Attachment
Department of Health & Human Services,
Rockville, MD 20857,
November 20, 1996.
Raymond R. Sackler, M.D.,
President, The Purdue Frederick Company,
100 Connecticut Avenue,
Norwalk, CT 06850-3590.
RE: NDA# 19-516,
MS Contin (morphine sulfate controlled release) Tablets,
MACMIS ID #4247
Warning Letter
Dear Dr. Sackler: This Warning Letter concerns The Purdue Frederick
Company's (Purdue) promotional materials for the marketing of MS Contin
(morphine sulfate controlled release) Tablets. The Division of Drug
Marketing, Advertising, and Communications (DDMAC) has reviewed these
materials as part of its monitoring and surveillance program. We have
concluded that Purdue is disseminating promotional materials for MS
Contin that contain statements, suggestions, of implications that are
false or misleading in violation of the Federal Food, Drug, and
Cosmetic Act (Act), 21 U.S.C. Sec. Sec. 352(a) and 331(a) and
applicable regulations. This violation is occurring despite repeated
notification to Purdue by DDMAC that claims of product superiority were
unsupported and were false and/or misleading and in violation of the
Act.
The promotional materials disseminated by Purdue that are the
subject of this letter are represented to be ``reprints'' of an article
by Michael H. Levy entitled Pharmacologic Management of Cancer Pain
that appeared in Seminars in Oncology (Vol. 21, No. 6, pages 718-739),
December 1994. \1\ These materials were submitted to FDA by Purdue
pursuant to the post-marketing reporting requirements for promotional
labeling and advertising, 21 CFR 314.81(b)(3).
---------------------------------------------------------------------------
\1\ The materials Purdue represents to be reprints of the Levy
article are identified as
# OORM64 and # B4715. The OORM64 document appears to be a reprint of
the original article that was published in Seminars in Oncology.
Although portions of the article were deleted, these deletions are not
relevant to the issues in this letter. The promotional material
identified as B4715 is a booklet entitled Pharmacologic Management of
Cancer Pain by Michael H. Levy states that it was ``reprinted with
permission'' citing to the original Levy article and was disseminated
by Purdue. However, the content of the booklet is substantially
different than the Levy article.
---------------------------------------------------------------------------
This Warning Letter does not concern Dr. Levy's published article.
It does concern the use of reprints and promotional materials derived
from the article that were disseminated by Purdue in its promotion of
MS Contin.
Violations
These promotional materials contain false and/or misleading
statements and suggestions that MS Contin is superior to other
analgesics, either in effectiveness, safety, or other parameters, in
the management of cancer pain. Specifically, the article states or
suggests that controlled-release morphine (MS Contin) is superior to
other opioid analgesics for chronic cancer pain. According to the
modified reprint of the Levy article, \2\
---------------------------------------------------------------------------
\2\ The page numbers cited above refer to the modified reprint of
the Seminars in Oncology article identified as # OORM64. The booklet, #
B4715, does not have the identical content, but also contains
suggestions that MS Contin is superior to other analgesics.
---------------------------------------------------------------------------
``Controlled-release morphine (MS Contin) is the best
opioid analgesic for pain prevention in patients with chronic cancer
pain.'' (See page 724).
``MS Contin is recommended over Oramorph based on the
smaller size and the color-coding of its tablets and the availability
of its 15-mg and 200-mg dosage forms.'' (See page 724).
``Because of its 12-hour dosing interval, MS Contin is the
preferred opioid analgesic for these patients along with PRN
supplements of MSIR for breakthrough pain.'' (See page 727).
As you know, there are a variety of analgesic products, including
other opioid products, other morphine products and other analgesic
products for chronic cancer pain. Purdue has not demonstrated that MS
Contin is superior in safety or effectiveness to either other morphine
products, other opioid products, or other products used for pain
control in cancer patients.
Repetitive Conduct
The dissemination of these materials represents a repetitive course
of violative conduct by Purdue in the promotion of MS Contin. Purdue
has repeatedly disseminated materials that contain unsupported claims
that MS Contin is superior to other analgesics including Oramorph. Such
unsupported superiority claims have also appeared in brochures that
targeted patients with cancer pain. DDMAC determined that these claims
were false and/or misleading on several occasions and communicated this
to Purdue in letters dated October 15, 1993, March 25, 1994, June 7,
1994, July 7, 1994, and October 3, 1994, and at a meeting between FDA
and Purdue on March 24, 1994. Each of these instances involved Purdue's
dissemination of promotional materials containing unsupported claims
that MS Contin is, in some way, superior to its competitors' products.
Conclusion and Requested Actions
The materials and promotional messages Purdue disseminated contain
false and/or misleading information about the safety and effectiveness
of MS Contin. Accordingly, Purdue should propose a corrective action
plan, including the mailing and publication of a ``Dear Healthcare
Professional'' letter to disseminate corrective messages about the
issues discussed in this letter to all healthcare providers,
administrators at institutions, and organizations who received the
violative messages.
This corrective action plan should also include:
A. Immediately ceasing the dissemination of all materials that
contain false, misleading, or unbalanced claims that state, suggest, or
imply that MS Contin is better than other opioid analgesics, including
other controlled release morphine products, for the control and
management of cancer pain.
B. A complete listing of all advertising and promotional materials
that will remain in use and those that will be discontinued. Also,
provide two copies of all promotional materials for MS Contin that
Purdue intends to continue to distribute.
C. Within 15 days of the date of this letter, disseminating a
message to all Purdue sales representatives and marketing personnel
involved in the marketing and sales of MS Contin, instructing them to
immediately cease dissemination of all promotional materials and
messages discussed in this letter and providing each person a copy of
this letter.
The Dear Healthcare Professional letter and Purdue's corrective
action plan should be submitted to DDMAC for approval. After such
approval, the letter should be disseminated by both direct mail and
through a paid advertisement in all journals that contained
advertisements for MS Contin during the 12 months prior to the date of
this letter.
The violations discussed in this letter do not necessarily
constitute an exhaustive list. We are continuing to evaluate other
aspects of Purdue's campaign for MS Contin and we may determine that
additional remedial measures will be necessary to fully correct the
false and/or misleading messages resulting from Purdue's violative
conduct.
Purdue should respond to this letter no later than December 6,
1996. If Purdue has any questions or comments, please contact Thomas
Abrams or Norman A. Drezin, Esq. by facsimile at (301) 827-2831, or at
the Food and Drug Administration, Division of Drug Marketing,
Advertising and Communications, HFD40, Rm 17B-20, 5600 Fishers Lane,
Rockville, MD 20857. DDMAC reminds Purdue that only written
communications are considered official.
Failure to respond to this letter may result in regulatory action,
including seizure and/or injunction, without further notice.
In all future correspondence regarding this particular matter,
please refer to MACMIS ID #4247 in addition to the NDA number.
Sincerely,
Minnie Baylor-Henry, R.Ph., J.D.,
Director, Division of Drug Marketing,
Advertising and Communications.
______
Senator Reed. Dr. Clark?
Dr. Clark. Thank you, Mr. Chairman. I am grateful for the
opportunity to address this committee on the issue of
treatment, substance abuse treatment and prevention associated
with OxyContin abuse and addiction.
To begin with, I would like to agree with the members of
this committee on the scope of the issue, the current problem
of OxyContin. This is merely the newest part of a prescription
opiod diversion and abuse problem that has been rising since
the mid-1980s. If you will look at this chart here, it shows
from SAMHSA's national household survey on drug abuse data that
the incidence of new prescription opiod abuse and the number of
new prescription opiod abusers has been rising steadily since
well before the introduction of OxyContin.
The emergency room data from SAMHSA's Drug Abuse Warning
Network in the next figure shows that the total number of
OxyContin mentions is about half that of hydrocodone mentions.
OxyContin, of course, is only one of the marketed forms of
oxycodone, which also includes other well known brands such as
Percodan and Percoset.
So it is clear, as was stated by others, that we are
dealing with a larger global issue of prescription drug abuse
and it is important that we keep this in mind as we develop
strategies of prevention, treatment, law enforcement strategies
to deal with the issue of prescription drug abuse.
Of course, rural States have been seeing abuse and
addiction with prescription opiods for some time. For instance,
Alaska has reported that there are about 15,000 prescription
opiod abusers in the State and that most methadone patients are
not heroin-addicted but addicted to those prescription opiods.
Even back when Arkansas was opening its first methadone clinic
in December of 1993, the vast majority of its patients were not
admitted for heroin addiction but for addiction to prescription
opiods. When seeking treatment previously, these patients had
to travel to other States because methadone treatment was not
available at that time in Arkansas.
This continues to be the case today, for example, in the
State of Mississippi. Our colleagues at the American
Association for the Treatment of Opiod Dependence report that
they have documented at least 500 Mississippi residents needing
opiod agonist treatment that must travel to one of the adjacent
States that do not allow for this life-saving medical therapy.
For patients who do not run into addictive problems with
their medications or persons who do not start with a pain
problem at all but who obtain diverted prescription opiods to
further an existing drug abuse or addiction, we have several
treatment strategies and we have been working with ONDCP, the
FDA, NIDA, NIAAA, DEA and other Federal agencies so that we can
have a rational strategy.
I would like to note that the president's new budget
addresses the important general problem associated with the
treatment gap. The president proposes in fiscal year' 03 a $127
million increase as the next installment of a five-year drug
treatment initiative to reduce the difference between the
number of Americans who need treatment for addictive disorders
and the number that receive treatment. The president's proposal
is, I think, a positive step. This will give us for our new
fiscal year $60 million for the substance abuse block grant to
the States and an additional $67 million for competitive drug
treatment grants, which can be specifically targeted to urgent
local needs, such as the one that we are talking about.
The treatment gap for opiod addiction is extremely
important because it is estimated that there are over 1 million
Americans addicted to illicit or licit opiods and only about
200,000 officially enrolled in medication-assisted treatment
programs and this is an important thing because it is most
difficult to find treatment for opiod addiction, especially in
rural areas of our country, but that is exactly the location of
the most urgent new reports of abuse and addiction with opiod
drugs.
Substance abuse treatment providers, of course, as you have
already mentioned, tell us that OxyContin addiction is so
strong that people will go to great lengths to get the drug,
including robbing pharmacies and writing false prescriptions. A
recently opened methadone treatment facility in Southwest
Virginia began receiving telephone calls from people seeking
treatment for OxyContin addiction even before it opened. Eighty
percent of the patients entering this now-functioning out-
patient treatment program name OxyContin as their primary drug
of abuse. The new continuing reports of rural OxyContin
tragedies have brought the rural opiod treatment gap into
sharper contrast.
In September 2000 we at CSAT initiated a small project with
Dr. Steven Savage of the Dartmouth Medical School and the New
Hampshire Medical Society. The New Hampshire Regional Medical
Opiod Treatment and Education Project is designed to be a
ground-breaking planning strategy to reach out to primary care
docs and other docs within the State so that opiod treatment
will be more readily available.
Following that effort we have at SAMHSA allocated as a
result of appropriations $500,000 for a CSAT community action
grant targeted for planning for local communities, rural
communities, and that effort is to involve State and local
communities in developing opiod treatment services to meet the
unique needs of rural communities and to address new and
emerging treatment needs related to increased availability of
prescription opiod medications and heroin so that we can begin
to address this problem.
We have worked with the State of Connecticut since 1997 to
fund demonstrations of office space opiod treatment and we
believe that this may serve as one appropriate model for
treatment that could help rural physicians. And we have had
similar projects working with the National Institute of Drug
Abuse funded in New York and we have worked closely with NIDA
and the Food and Drug Administration and the New York State
Office of Alcoholism and Substance Abuse Services to help
develop models of opiod treatment based on community pharmacies
so that we can expand opiod assisted treatment to people in
need, particularly in rural communities.
We anticipate, with the work of others in the field,
including NIDA, the release of a new product called
Buprenorphine sometime this year which will assist us in
allowing primary care docs in communities to use another
medication in addition to methadone.
SAMHSA has been working with State medical boards and their
Federation of State Medical Boards, as well as the American
Society of Addiction Medicine, the American Osteopathic Academy
of Addiction Medicine, the American Academy of Addiction
Psychiatry and the American Psychiatric Association and other
medical organizations to create a standardized medical
curriculum, a treatment improvement protocol with guidelines,
best practices, and a number of continuing education courses.
We had, in fact, a course in March of 2000; we sponsored a
Buprenorphine training course in Newport, RI so that we could
get physicians trained. We have trained about 1,500 physicians.
We have also consulted with States. In July of 2000 we were
in Bangor, ME at the invitation of the mayor, city council and
the citizens and we were talking about medication-assisted
therapies, specifically methadone, as a result of their
OxyContin and heroin problem.
So we realize that this is going to be an on-going process.
We will continue to work with local communities, States, the
FDA, the Department of Justice, Drug Enforcement
Administration, and others so that we can make sure that the
issue of treatment and prevention and the mental health
component because I would like to point out that many people
who become dependent on opiods also have concomitant
psychiatric problems that need to be addressed, so we are
working aggressively with the community and continue to take
instructions from members of this committee and the Congress on
this issue.
We would like to point out that most people who have pain
and take OxyContin for the pain do not become addicts and that
is an important thing. In fact, the data seem to suggest that
the people who have problems with OxyContin have problems with
addiction and not with pain. Now that does not mean that there
is no overlap but I think it is an important thing to keep in
mind because members of this committee have raised that issue
and we would like to echo that.
And pain patients, pain does not necessarily protect the
patient who may otherwise be at risk for addictive disorders.
Pain patients with addictive histories require additional
safeguards when opiods are required for management of the pain.
Withholding opiod analgesics from these patients, however, is
not necessarily the safest course of treatment. They often know
all too well where they can obtain what they need for pain
relief but from a much more dangerous source. Patients with
both chronic pain and opiod addiction require careful
management but they can be and should be managed for both
disorders concurrently.
Medical experience in this area is growing. We are
participating with--we have contributions from people on your
panels and from people who are interested in the appropriate
management of pain patients and we will continue to work with
them.
Mr. Chairman, thank you again for the opportunity to appear
before this committee.
Senator Reed. Thank you very much, Dr. Clark.
[The prepared statement of Dr. Clark follows:]
Prepared Statement of H. Westley Clark, M.D., M.P.H., J.D.
Mr. Chairman, I am grateful for the opportunity to address this
Committee regarding the treatment of OxyContin(A) addiction and the
prevention of further drug abuse through effective medical
interventions for addiction to OxyContin and other prescription and
nonprescription opioids. Before delivering my remarks on this very
important and timely topic, I would like to thank the Committee for its
attention to this issue, and for your recognition of the importance of
addiction treatment in the drug abuse equation, that you demonstrate by
today's invitation to the Substance Abuse and Mental Health Services
Administration (SAMHSA). As the Director of SAMHSA's Center for
Substance Abuse Treatment (CSAT), I am responsible for leading SAMHSA's
substance abuse treatment effort.
As you know, SAMHSA is the lead Federal agency for improving the
quality and availability of substance abuse prevention, addiction
treatment and mental health services in the United States. SAMHSA has
both funding authority and certain key regulatory responsibilities that
will play a central role in the national response to abuse of and
addiction with OxyContin and the many other prescription analgesics
which can be abused by Americans in the grip of opioid addiction. It
must be recognized that the abuse of OxyContin is not primarily by
those who are pain patients but by those who are opioid addicts. In
diverting and abusing prescription opioids, these addicted Americans
hurt not only themselves, their families and those around them, but
they also hurt the pain patients, who have ongoing needs for these
medications, and for whom these medications sustain life and improve
function, rather than endangering life and destroying function, as they
do in the untreated disease of opioid addiction. I have worked as a
physician for many years in this area of practice, and have published
on the use of opioids in the treatment of chronic pain and on the
assessment of addiction in that setting.
Most people who take OxyContin and other prescription opioids, as
prescribed, do not become addicted. With prolonged use of opioids,
however, pain patients often do become tolerant, that is, require
larger doses, although this does typically reach a plateau, which can
vary markedly between different patients and different pain conditions.
Chronic pain patients can also become physically dependent on their
medications. However, most patients who receive opioids for pain, even
those undergoing long-term therapy, do not become addicted to these
drugs.
Addiction in the course of opioid treatment for pain should ideally
be assessed after the pain has been brought under adequate control,
though this is not always initially possible. Addiction is recognized
by one or more of its characteristic features: impaired control,
craving and compulsive use, and continued use despite negative
physical, mental, and/or social consequences. Sometimes patient
behaviors that might suggest addiction are simply a reflection of
unrelieved pain. This has been called pseudo-addiction, and is an
important misdiagnosis to be avoided in pain patients. Therefore,
medical judgment must be used in determining whether a concerning
pattern of behaviors in a pain patient signals the presence of
addiction or whether it reflects a different medical problem.
In short, most individuals who take their prescribed OxyContin, or
any other opioid such as 2 hydrocodone or morphine, under medical
treatment for pain, will not become addicted, although some may become
physically dependent on the drug and may need to be carefully withdrawn
after their pain problem is otherwise resolved. Patients who are taking
these drugs as prescribed should continue to do so, as long as they and
their physician agree that taking the drug is a medically appropriate
way for them to manage pain.
For patients who do run into addictive problems with their
medication, or for persons who didn't start with a pain problem at all,
but who obtained diverted prescription opioids to further an existing
syndrome of drug, abuse and addiction, we have a range of very
effective treatments, to be described in more detail below. However,
the system that provides these treatments has historically been
fragmented and underfunded. The Presidents' new budget addresses this
important general problem by proposing an increase of $127 million for
the next year of a five-year drug treatment initiative to help reduce
this treatment gap in the United States, to reduce the difference
between the number of Americans who need treatment for addictive
disorders and the number that receive the treatment and services to
manage their illness and rebuild their lives. The President's current
proposal is for the second year of this five-year initiative. Secretary
Thompson has confirmed that ``There continues to be a great need to
expand our nation's capacity to treat people who are addicted.'' and
that ``This administration is committed to supporting local programs
that combat the personal despair and community disintegration brought
by drug addiction.'' Our new fiscal year 2003 budget requests an
increase of $60 million for the Substance Abuse Block Grants to the
States and an additional $67 million for competitive drug treatment
grants, which can be specifically targeted to urgent local needs such
as those we are discussing today.
There is a particularly large treatment gap when it comes to
treatment for opioid addiction, with estimates of over one million
Americans addicted to licit or illicit opioids, and only about 200,000
patients enrolled in effective medical treatment programs. It is most
difficult to find treatment for opioid addiction especially in the
rural areas of our country. But that is exactly the location of the
most urgent new reports of abuse and addiction with prescription
opioids. 3 Many reports of abuse and addiction are occurring in rural
areas that have labor-intensive industries, such as logging or coal
mining. These industries are often located in economically depressed
areas, as well. Therefore, people for whom the drug may have been
legitimately prescribed may be tempted to sell their prescriptions for
economic reasons. Substance abuse treatment providers tell us that
OxyContin addiction is so strong that people will go to great lengths
to get the drug, including robbing pharmacies and writing false
prescriptions. A recently opened methadone treatment facility in
southwest Virginia began receiving telephone calls from people seeking
treatment for OxyContin addiction before it was even open. Eighty
percent of patients entering this now fully- functional outpatient
treatment program name OxyContin as their primary chug of abuse. The
new millennium's continuing news reports of a rural OxyContin tragedy
have brought this rural opioid treatment gap into even sharper contrast
for those of us already familiar with the treatment gap as a whole.
Even before this tragic news began to break, SAMHSA was already
planning to pilot new ways of working with the medical community to
provide exemplary models of medical treatment for opioid addiction in
rural areas. In September of 2000, we at CSAT initiated a small project
with Dr. Seddon Savage, of the Dartmouth Medical School and the New
Hampshire Medical Society. The New Hampshire Regional Medical Opioid
Treatment and Education Project, (NH ReMOTE), was a groundbreaking
treatment planning project. It's chief objectives were to assess
addiction treatment needs and resources in various communities in New
Hampshire, and to plan development of primary care office based
management of addictive disease, including medical therapy of opioid
addiction, at several sites around the State. NH ReMOTE was the first
project in the United States to target development of a statewide
office-based treatment system for opioid addiction.
Primary care physicians, interested in expanding their care of
individuals with addictions, are being drawn from 8-10 sites
geographically distributed through the state. Physicians will be linked
with addiction counselors and social and vocational services in their
region to form integrated care teams for patients with addictive
disorders. Hospital or other established local pharmacies will dispense
opioid medications to patients requiring opioid addiction treatment
under direction of the treating physician. The NH ReMOTE Project will
develop regulatory and documentation systems to support effective
medical treatment practices.
A central resource group of professionals experienced in therapy of
opioid addiction, will be available to provide consultation as needed
to the regional care providers. This group will likely be drawn from
existing free-standing specialty addiction treatment clinics. Patients
requiring opioid therapy who cannot successfully be managed by the
regional teams will receive care managed by this central group of
experts.
All personnel involved in the regional care teams will receive
training requisite to fulfilling their role on the care team. Physician
training will include education in general addiction medicine and
specific training in opioid therapies, including the use of methadone,
LAAM, naltrexone and buprenorphine. I will return later to describe
these specific medication assisted therapies for opioid addiction.
The initial response of the medical community to New Hampshire
ReMOTE was very promising. So, while we were publishing our first CSAT
Advisory on OxyContin: Prescription Drug Abuse, in April of 2001 (which
I have brought for the Committee), we were already working on an
additional $500,000 to be allocated to the CSAT Action Grant Program
for similar purposes. The purpose of that special announcement, for
which applications were received in September, 2001, was to provide
leadership in developing consensus among key stakeholders in additional
State and local communities toward the goal of developing opioid
treatment services to meet the unique needs of rural communities, and
to address new and emerging treatment needs related to the increased
availability of heroin or prescription opioid medications, such as
oxycodone or hydrocodone, and to support exemplary practice models for
rural communities experiencing problems with opioid addiction. Proposed
projects were intended to help treatment providers, including
physicians, hospitals, community health centers and community mental
health centers adopt exemplary practice models for opioid 5 treatment
into their communities. These exemplary practices will be targeted at
delivering medication assisted therapy to rural populations where
previous access to opioid treatment services has been limited or
nonexistent. We anticipate that grants will be awarded this Spring
under this special funding opportunity. While I cannot comment on
specific grant proposals currently under review, I will say that some
excellent and important projects are anticipated to start this fiscal
year.
We have also worked with the State of Connecticut, since 1997, to
find pilot demonstrations of office-based opioid treatment (OBOT),
which we believe may serve as one appropriate model of treatment that
could be provided in the offices of rural physicians. Similar projects
have been funded in New York by the National Institute on Drug Abuse
(NIDA), and we have worked closely with NIDA, the Food and Drug
Administration (FDA) and the New York State Office of Alcoholism and
Substance Abuse Services to develop models of opioid treatment based on
community pharmacies, such as may also be found in rural communities.
Now that I have spoken specifically to what we are doing about
rural opioid addiction treatment, I would like to speak more generally
about the medical therapy of opioid addiction, and CSAT's programs to
increase the quantity and availability, as well as the quality and
effectiveness, of treatment for this potentially devastating illness.
Abuse of prescription pain medications is not new. However, two
primary factors, set apart OxyContin abuse from other prescription drug
abuse:
First, OxyContin contains a much larger amount of the
active opioid ingredient (oxycodone) than most other prescription pain
medications. By crushing the tablet and either swallowing or snorting
it, or by injecting the dissolved tablet, abusers feel the effects of
the opioid in a short time, rather than over a 12-hour span. It is this
high rate at which drug gets to the brain, as well as the overall dose
taken, that makes for a greater effect on the brain's reward centers
and 6 the consequent chemical highjacking of those centers that we call
addiction.
Second, great profits can be made from the illegal sale of
OxyContin. A 40-milligram pill costs approximately $4 by prescription,
yet it may sell for $20 to $40 on the street, depending on the area of
the country. OxyContin is comparatively inexpensive when purchased
legitimately, especially if its cost is covered by insurance. However,
because heroin is usually less expensive than OxyContin purchased
illegally, the National Drug Intelligence Center reports that OxyContin
abusers may often turn to heroin, if their insurance will no longer pay
or they otherwise lose access to their OxyContin prescriptions.
Two types of treatment have been documented as effective for opioid
addiction. One is a long-term, residential, therapeutic community type
of treatment and the other is long-term, medication-assisted outpatient
treatment. Medication-assisted opioid treatment can utilize medications
that are agonists, antagonists, or partial agonists. An agonist
medication is one that has the same basic effect at the brain cell
membrane as the drug of abuse. However, there may be crucial
differences in how fast it creates this effect and how long the effect
lasts. An antagonist drug simply blocks the effect of agonist drugs,
including the drug of abuse. A partial agonist drug has less effect at
the brain cell membrane as the ``Full'' agonist, but it also serves to
block the full agonist, so the partial agonist medication, such as
buprenorphine, may combine certain treatment advantages of both other
kinds of medication.
Some opioid-addicted patients with very good social supports may
occasionally be able to benefit from antagonist maintenance with
naltrexone. This treatment works best if the patient is highly
motivated to participate in treatment, has strong social support, and
has been adequately detoxified from the opioid of abuse. Most opioid-
addicted patients in outpatient therapy, however, will do best with
medication that is either an agonist or a partial agonist. Methadone
and levo alpha acetyl-methadol (LAAM) are the two agonist medications
currently approved for addiction treatment in this country. Prior to
May of 2001, providers of this treatment were regulated by the Food and
Drug Administration (FDA). In May, 2001, SAMHSA took over the
regulation of opioid agonist treatment (OAT) providers under the new
part 8 of 42CFR. We now have major initiatives underway to modernize,
improve, mainstream and expand this 7 treatment modality. These include
our use of an accreditation based system, similar to that used in most
other kinds of medical facilities and along the lines that have
previously been recommended by the 1995 Institute of Medicine (10M)
Report on Federal Regulation of Methadone Treatment (available at:
http://www.nap.edu/books/0309052408/html/) and the 1997 NIH Consensus
Conference Report on Effective Medical Treatment of Opiate Addiction,
(available at: http://odp.od.nih.gov/consensus/cons/108/108-intro.htm).
The guidelines for treating OxyContin addiction are basically no
different than the medical guidelines for treating addiction to ANY
opioid. There is one important thing to remember, however: because
OxyContin contains higher dose levels of opioid than are typically
found in other oxycodone-containing pain medications, higher dosages of
methadone or other medications may be needed to adequately treat
patients who are addicted to OxyContin.
Methadone or LAAM may be used for OxyContin addiction treatment or,
for that matter, treatment for addiction to any other opioid, including
the other prescription opioids. This is not a new treatment approach.
Rural States have been seeing abuse and addiction with prescription
opioids for some time. For instance, Alaska has reported there are
about 15,000 prescription opioid abusers in the State and that most
methadone patients are not heroin-addicted, but addicted to those
prescription opioids. Even back when Arkansas opened its first
methadone maintenance clinic in December of 1993, the vast majority of
its new patients were not admitted for heroin addiction, but for
addiction to prescription opioids. When seeking treatment previously,
these patients had to travel to other States because methadone
treatment had not been available in Arkansas. This continues to be the
case, for example, in the State of Mississippi. Our colleagues at the
American Association for the Treatment of Opioid Dependence (AATOD)
report that they have documented at least 500 Mississippi residents
needing opioid agonist treatment that must travel to one of the
adjacent States who do allow for this life-saving medical therapy.
Some persons in the few States that still don't allow the fall
spectrum of medical therapies for opioid addiction may believe their
remaining problems will be solved by the advent of buprenorphine, the
new partial agonist opioid treatment. This kind of medication shares
certain properties with the antagonist medication naltrexone as well as
the opioid agonists, and is safer than, although not as therapeutically
powerful as, Methadone or LAAM.
Partial agonist opioid medication will be an important new tool in
the medical arsenal against addiction, but it certainly won't be able
to replace the current medications. Presently there is no partial
agonist approved by the Food and Drug Administration (FDA) for use in
addiction treatment, although a form of Buprenorphine, researched by
the National Institute on Drug Abuse (NIDA) and its partners in
academia and industry, holds great promise and we are told that this
medication is likely to be approved by the FDA in the next 3-6 months
for the treatment of opioid addiction. This medication, in conjunction
with new authority provided to DHHS and redelegated to SAMHSA under the
Drug Addiction Treatment Act of 2000 (P.L. 106-310 (21 U.S.C.
823(g)(2)), is expected to make significant gains possible in expanding
access to opioid addiction treatment in rural and other under-served
areas of the country.
The Drug Addiction Treatment Act (DATA) amended the Controlled
Substances Act to permit physicians to seek and obtain waivers to
prescribe approved narcotic treatment drugs for the treatment of opiate
addiction. The waivers will permit qualified physicians to prescribe
Schedule III, IV, or V opioid medications, when approved by FDA for the
treatment of opioid addiction. These physicians would be required to
refer the patients for appropriate counseling and limit his or her
practice of this treatment to 30 patients. However they would otherwise
be exempted from the requirements of the Narcotic Addict Treatment Act
(NATA) which otherwise governs the use of scheduled opioids for
addiction treatment under 42CFR8, which as I mentioned before, is now
also administered by SAMHSA. The NATA remains in place for Schedule II
opioids approved for addiction treatment (Methadone and LAAM). Once
there is a form of Buprenorphine approved by the FDA, and the new
product is scheduled by the Drug Enforcement Administration (DEA) in
Schedule III, IV, or V, then most of the provisions of the DATA will go
into effect and SAMHSA will be accepting applications for waivers from
qualified physicians.
The DATA contained a limited Federal preemption, to allow for rapid
implementation of this new office-based treatment approach across all
of the States. However, States can still opt out by passing new
legislation. In states that do not opt out legislatively, use of
Buprenorphine under the DATA will immediately become part of the
medical practice of the physicians who obtain the waiver from SAMHSA
and a corresponding number from DEA, related to their existing
controlled drug registration number. SAMHSA staff have been working
with the State Medical Boards and their Federation of State Medical
Boards (FSMB) to develop guidelines to help the Boards fulfill their
responsibilities for oversight of this new and unfamiliar area of
medical practice.
SAMHSA has also been working with the American Society of Addiction
Medicine (ASAM) the American Osteopathic Academy of Addiction Medicine
(AOAAM), the American Academy of Addiction Psychiatry (AAAP), the
American Psychiatric Association (APA) and other medical organizations
to create a standardized medical curriculum, a Treatment Improvement
Protocol (TIP) with guidelines for best medical practices, and a number
of continuing medical education (CME) courses which have trained 1500
physicians from across the country, including many rural physicians who
have been especially eager to prepare for this new opportunity to
provide effective medical treatment for opioid addicted patients in
their communities.
I This 1500 physicians SAMHSA and our partners have trained is in
addition to those who may be already qualified by Virtue of having been
previously certified as addiction treatment specialists by one or more
of the organizations specified in the DATA. Although many physicians
qualified by previous certification in addiction have also sought the
additional eight hours mandated under the DATA for physicians who do
not already have such recognized certification.
In addition to our partners in the States and in the medical
organizations, we continue to work on these issues with our Federal
partners, in a variety of ways. For instance, the Interagency Narcotics
Treatment Policy Review Board (INTPRB), which I currently chair, has
created a special working group on the problem of OxyContin and other
prescription drug diversion. The organizations participating in the
INTPRB and our work group are as follows:
1. Department of Justice (DOJ)
1.1 Drug Enforcement Administration (DEA)
1.2 National Drug Intelligence Center (NDIC)
1.3 National Institute of Justice (NIJ)
2. Food and Drug Administration (FDA)
2.1 Center for Drug Evaluation and Research (CDER)
3. Substance Abuse and Mental Health Services Administration (SAMHSA)
3.1 Center for substance Abuse Treatment (CSAT)
3.2 Office of Applied Studies (OAS)
4. National Institute on Drug Abuse (NIDA)
5. Office of National Drug Control Policy (ONDCP)
6. DHHS Office of the Secretary, Office of Public health and Science
(OPHS)
7. Centers for Disease Control and Prevention (CDC)
8. Health Resources and Services Administration (HRSA)
9. Centers for Medicare & Medicaid Services (CMS), and
10. Veterans Health Administration (VHA).
I want to conclude by pointing out to the committee, that although
physical dependence in a pain patient on opioids is differentiable from
opioid addiction, pain does not necessarily protect the patient who may
be otherwise at risk for addictive disorders. Pain patients with
addictive histories may well require additional safeguards when opioids
are required for management of their pain. Withholding opioid
analgesics from these patients is not necessarily a safe course at all,
as they may know all too well where they can obtain what they need for
pain relief, but from a much more dangerous source that would
significantly increase their risk of relapse. Patients with both
chronic pain and opioid addiction may require very careful management,
but they can and should be managed for both disorders concurrently.
Medical experience in this area grows slowly and is not yet well
defined. However, a notable case series reported in the Journal of Pain
and Symptom Management (1996) by Dunbar and Katz, described 20 patients
with both chronic pain and substance abuse problems, on chronic opioid
therapy for intractable pain. Nine out of 20 did have at least some
abuse of their medications, but the MAJORITY DID NOT. Of the eleven who
did NOT abuse their medications, ALL were active in drug abuse recovery
programs with good family support. This small but important study
illustrates not only that some pain patients with histories of drug
problems can benefit from, may require and can handle opioid pain
management, but it also demonstrates the central importance of an
active recovery program and good family support in the long-term
management of opioid addiction, and for that matter, in the successful
management of most addictions.
Mr. Chairman, I thank you again for this opportunity to appear
before the Committee today. I would be happy to answer any questions
that you or any other members of the Committee may have at the
appropriate time.
Senator Reed. Dr. Jenkins, you indicated in your testimony
that the FDA was surprised that this very useful drug was being
abused. Did that cause you and your agency to go back and look
at the system of approval and retrospectively make any judgment
about what you might have done differently?
Dr. Jenkins. Mr. Chairman, we did not predict when
OxyContin was approved in 1995 that we would see this level of
abuse and misuse of the product. Part of our thinking at that
time was based on the fact that there is a similar product
called MSContin that contains morphine that had been approved
for approximately 8 years by the time OxyContin was approved in
1995 and we had not seen a significant problem of abuse and
misuse of that product as we have with OxyContin. Of course,
all opiates are subject to abuse and misuse.
In answer to your question, we have evaluated our structure
and our procedures for approving sustained release as well as
other opiates and we certainly will take into account the
potential risk of serious abuse and misuse in any future
approvals, particularly for sustained release products like
OxyContin.
Senator Reed. Doctor, your answer raises another question--
what is the difference between OxyContin and MSContin? I mean
both time release drugs.
Dr. Jenkins. They are both time release.
Senator Reed. Both have an opiate base, I presume.
Dr. Jenkins. MSContin contains morphine. OxyContin contains
oxycodone. They are both Schedule II narcotics with very
similar abuse potential.
Senator Reed. But is there any theory at this point from
your perspective at the FDA why one was reasonably well
tolerated by the public and the other one became so abused?
Dr. Jenkins. We really do not know the reason for the
widespread abuse of OxyContin and the lack of such abuse of
MSContin. The only suggestion of an explanation I have heard
that I think has some credence is that most people in the
community recognize the word morphine as being a narcotic and
might be adverse to receiving a product that contains morphine,
whereas OxyContin does not carry that same recognition and/or
stigma in the community, so maybe patients and/or physicians
were more comfortable prescribing something that was not called
morphine.
Senator Reed. Let me ask another question related to the
approval process. Was OxyContin a priority, new drug
application?
Dr. Jenkins. I do not believe it was, sir. I could check to
be sure but I do not believe it was.
Senator Reed. Before I turn to Dr. Clark, there are several
elements within the chain of distribution of controlled
substances--doctors and pharmacists, etc. Can you just briefly
comment on the role in this OxyContin situation of physicians
and pharmacists? Have you noticed any overprescriptions, any
lack of education on the part of either the physician or the
pharmacist?
Dr. Jenkins. As you know, Mr. Chairman, this is a Schedule
II narcotic so there are restrictions in place under the
Controlled Substances Act about recordkeeping and prescribing
narcotics of this type.
Prescribing and dispensing a prescription is primarily a
State-based activity, so we do not have specific data that we
have collected on that, although we have heard reports in the
media about physicians misprescribing or overprescribing and,
of course, as has been mentioned here, we have heard of the
reports of thefts from pharmacies, as well as from patients.
Senator Reed. But that would go to a board of licensure in
each State to follow through and investigate?
Dr. Jenkins. Right. The licensing of physicians and
pharmacists is a State-based responsibility.
Senator Reed. One final point, Doctor. You mentioned that
you have been working with the manufacturer and you are not
aware of any direct promotion of OxyContin to the larger
public; that is being handled through just physicians.
I would note that I am not suggesting this is the
manufacturer but we went on the Web and discovered that you can
find access to OxyContin at the click of your mouse and I would
hope that as you go back to the FDA and law enforcement
authorities would look also into this situation. I do not know
and I do not suspect that this is the company in any way doing
it but somebody is out there marketing directly to the general
public.
Dr. Jenkins. Mr. Chairman, we have no knowledge that Purdue
Pharma has anything to do with these types of Internet sales.
Senator Reed. I am not suggesting they are.
Dr. Jenkins. We are aware of these Internet sites. As you
can imagine, it is very difficult in many cases to regulate
what appears on the Internet because a lot of these tend to be
foreign sites. We generally have deferred in this area to the
Drug Enforcement Administration to take legal action in these
cases but we are concerned about the types of sites that you
are displaying.
Senator Reed. Thank you very much, Doctor.
Dr. Clark, let me ask a question of you. From your
perspective, are these cases of OxyContin abuse concentrated in
rural areas? Is it spreading into other areas? What can you
tell us about the distribution of the abuse, if you will?
Dr. Clark. Well, as Senator Collins pointed out, it came to
our attention about OxyContin when we went to Bangor, ME and,
as she pointed out very correctly, it was completely absent in
the mass media. And when I, as part of my job, I would go to
places across the country and I would ask about OxyContin based
on my experience in Maine and California had not heard of it in
terms of treatment programs, etc.
But with the ensuing focus and attention, addicts are very
sophisticated. They read the newspaper; they are on line and
there has been a lot of information. I think unfortunately we
have a case of the dog chasing his tail in terms of more
information and with more information, people start trying it.
The newspapers in Bangor, that is where I found out about
crushing the pill and scraping it away; there was a whole
description of that.
So I think addicts pay close attention to the media and as
a result of that, we have got, for economic reasons perhaps in
rural America, the exchange of OxyContin, and I have heard that
argument put forth a lot. But now we are seeing in other
jurisdictions, as Senator Clinton pointed out, the OxyContin
abuse surfacing, so it is no longer restricted to rural
America. It is seen as an effective way of getting high. So it
is diffusing into the rest of America, if you will.
Senator Reed. Thank you very much.
Senator Collins?
Senator Collins. Thank you very much, Mr. Chairman.
Dr. Clark, I first want to start by acknowledging and
thanking you for the attention and assistance that you have
given my State as it is attempting to deal with this unexpected
epidemic.
You mentioned in your statement the treatment gap that
makes it very difficult for people living in more isolated
areas and rural areas to access substance abuse services and
that is certainly a problem in Washington County and other
rural areas of my State. So therefore I would be remiss if I
did not let you know that the State of Maine has at least two
grant proposals pending in your office that would deal with
this treatment shortage and I certainly hope that you will take
a close look at those because in all seriousness, this is a
real problem, just getting these addicted individuals the
services and the help that they need.
Dr. Jenkins, I want to follow up on the issue of the
marketing of OxyContin. Asa Hutchinson, who is the
administrator of the Drug Enforcement Administration, recently
testified over on the House side on issues relating to the
abuse of OxyContin and in his testimony he first noted, ``a
dramatic increase in the elicit availability and abuse of
OxyContin'' and went on to conclude that there has been ``a
disproportionate abuse of the drug due in part to the
aggressive marketing and promotion of OxyContin by Purdue
Pharma, who represented the product as having a lower abuse
potential than other opiate pain relievers. Purdue Pharma
accentuated the problem by suggesting that physicians prescribe
OxyContin as a substitute for a variety of less addictive
existing medications.''
As the agency responsible for oversight of drug marketing,
I would like to ask your assessment of the DEA administrator's
testimony, whether you agree with that, whether you think FDA
needs to take further actions on the marketing of this drug.
Dr. Jenkins. Thank you, Senator. FDA does regulate the
promotion and marketing of drugs approved by our agency and we
have reviewed the materials that have been submitted by Purdue
Pharma as part of their promotion and marketing campaign and
with the single exception I cited in my testimony, all those
have been found to be within the FDA regulations for being not
false and misleading, to be fair and balanced, and to
accurately represent the product as it was labeled at the time
the advertisements were being disseminated.
We do not regulate the extent to which a company may choose
to promote or market their product. By that I mean the number
of advertisements or the frequency of advertisements.
So overall, we are not aware of promotional or marketing
activities that have been in violation of our act or our
regulations, except for that one case where we had an objection
and the company very quickly withdrew that advertisement.
Senator Collins. So you would not agree with Administrator
Hutchinson's analysis of the marketing of this drug?
Dr. Jenkins. Well, I would not say that I am agreeing or
disagreeing with Administrator Hutchinson. I will let him draw
his own conclusions about whether there is a link between the
marketing and the current problem. From our perspective we have
not seen anything that has been in violation of our
regulations.
Senator Collins. Was there not an FDA warning letter issued
to Purdue Pharma with regard to the marketing of MSContin? Are
you familiar with that?
Dr. Jenkins. Senator, off the top of my head I do not know
the details of that particular warning letter. I would be happy
to get back to you, if there was such a letter, with the
details.
Senator Collins. I believe there was and I would ask you to
get back to us on that.
Dr. Clark, do you have any insights on the question that
has been raised about the marketing of this drug and whether or
not it has been appropriate and whether physicians,
particularly family practitioners who may not have as much
expertise in pain treatment as a pain specialist, are receiving
adequate information?
Dr. Clark. Actually, Senator Collins, I do not. I recognize
that physicians--as a physician, much of our education comes
from formal courses but also from detailing from the
pharmaceutical industry and I always found that, as a busy
practitioner in the field, to be very helpful.
So as long as it is clear that the marketing is directed to
physicians, the fact of the matter is we have had a problem, an
epidemic of undertreatment of pain and I have been very much
interested in that for years. I have a paper from 1993 that is
on the table over there that addressed this question and this
preceded OxyContin, that physicians were reluctant to
adequately treat pain.
So I think what people in the field were trying to do is to
educate practitioners about this, so I do not think it is a
simple matter of marketing. I think what we have is a complex
social phenomenon and we need, as you have pointed out,
multiple solutions for it that include law enforcement,
education, prevention, treatment, and putting our heads
together and figuring out how to keep a good drug on the
market, pain patients, with medications that they need.
Senator Collins. I certainly agree with your premise that
we too often have undertreated pain in this country and I have
been working with Senator Jay Rockefeller for some time now on
end-of-life care and having greater access to pain medications
and to hospice care but I think we need to strike the right
balance in our educating physicians both ways on this issue,
and that is something we look forward to working with you on.
Just one quick question because I know my time is running
out. That is it has been suggested, and I would like both of
you to comment briefly on this, that reformulating OxyContin
might be the answer to the dilemma of making sure that this
valuable drug is available for those suffering from chronic
pain and yet could not be so easily abused, as it is now, by
being crushed and dissolved or snorted. Dr. Jenkins, are you
optimistic about that?
Dr. Jenkins. Senator, we are aware that the company is
undertaking efforts to try to reformulate the product to add an
opiate blocker, another ingredient that would block the effect
of the oxycodone if the product were crushed and injected
intravenously and possibly also block the effects of oxycodone
if the product were crushed and then snorted. So we are hopeful
that that will come to fruition.
One important point that we all need to be aware of, or
actually two important points, one is much of the abuse of this
product has been by the oral route, so the addition of the
blocking agents that are currently available will not be
effective by that route, since those agents are not absorbed
from the stomach. So it will help potentially in some of the
abuse by the intravenous and the internasal route but it may
not help with the oral abuse of the product.
The second thing that we always have to remember when we
start adding a second active ingredient to a product is that
the legitimate patients who are taking the product do not need
that second active ingredient, so you have to be careful that
that second active ingredient is not compromising the
effectiveness of the oxycodone and also is not exposing them to
an undue risk of adverse reaction.
So we are eagerly working with Purdue Pharma on those
efforts at reformation. I think they can be useful but they
will not solve the entire problem.
Senator Collins. Thank you.
Dr. Clark, in 30 seconds?
Dr. Clark. Well, reformulation will help educate physicians
about the importance of addiction as a possible risk associated
with the use of the drug and I think that is the most important
point. If people want to defeat the reformulation, they will be
able to figure out ways to defeat it. That is something that
you need to be aware of. As they say in the 12-step programs,
addiction is cunning, baffling and powerful, so you are dealing
with people who figure these things out because they do not
have to go through the NIH human subjects committees to
experiment with ways of dealing with these issues. Nor do they
have to get their techniques approved by the FDA.
Senator Collins. Thank you very much.
Senator Reed. Senator Dodd?
Senator Dodd. Thank you very much, Mr. Chairman, and thank
you both for the excellent testimony, I think this is helpful
to us here.
As I said at the outset in my prepared statement, I
represent Purdue Pharma, they are constituents of mine, and I
know them well and the people who work there. I have been down
there on numerous occasions during my service in the Senate. I
have a very, very high regard for them and their employees who
work very, very hard producing quality products.
I think you have identified here that the problem goes far
beyond a company. It is easier to identify a company when you
are trying to address this but I think the problem is far more
pernicious than the product produced by a single company. I
think that is what your testimony sort of indicates and I want
to just run through a couple of steps, if I can.
One, Dr. Jenkins, Purdue Pharma chose not to engage in
direct-to-consumer advertising of OxyContin. Is that not
correct?
Dr. Jenkins. To our knowledge, they have not done any
direct-to-consumer advertising.
Senator Dodd. So these web sites, these are not Purdue
Pharma web sites.
Dr. Jenkins. Not to my knowledge.
Senator Dodd. But there are currently no prohibitions
against it. With the Schedule II drugs, Purdue Pharma would
have been completely within its rights on a Schedule II product
to market that product directly to consumers. Is that not
correct?
Dr. Jenkins. That is correct.
Senator Dodd. So they made that decision not to do that.
Now the question arises do you believe that there should be
some restriction on Schedule II drugs in terms of should they
all be following the Purdue Pharma example of just marketing to
physicians and health-related agencies or the like?
Dr. Jenkins. Senator, I think we can commend Purdue Pharma
for the decision that they have made not to engage in that
activity. Whether there is need for change in the act would
require legislation and I do not think it is appropriate for me
to comment without the administration having a chance to take a
position on any proposed legislation.
Senator Dodd. I know, but you are not just talking to the
two of us. If I cannot get it from you, who am I going to get
it from? You are the FDA. Who am I supposed to call? Dick
Cheney?
We are going to have testimony on the next panel. Dr. Van
Zee on panel two is suggesting in his testimony that OxyContin
does not offer any major advantages over similar medications
and I wonder from a regulatory perspective can you comment on
this and why we need a number of similar opiod medications to
treat pain? That is not an illegitimate question and what is
the answer to it?
Dr. Jenkins. Senator, in our regulations in order for a
company to have a superiority claim, for example, in their
labeling saying we are superior to another product they have to
have substantial data from adequate, well controlled trials.
OxyContin currently does not have those types of claims in its
labeling.
I think the reason OxyContin was developed in the first
place as a controlled release mechanism was to allow patients
who have chronic pain to have a regimen that does not force
them to be constantly redosing every few hours because they are
having break-through pain because those products only last a
short period of time.
So the sustained release nature of the product I think is a
very valuable addition to the armamentarium. There are other
sustained release opiates that are approved and marketed in the
United States. We mentioned MSContin earlier. There are other
sustained release morphine products and there is actually a
sustained release transdermal patch of a narcotic called
Fentanyl and I think they are very valuable additions but there
is not evidence to my knowledge to suggest that a controlled
release product is more effective in treating pain than an
immediate release product.
Senator Dodd. Is there also something in the notion of
physiology? There are letters and other people who have
testified. This one woman here, I am quoting here now: ``I take
OxyContin every day for my pain. I am finding it more and more
difficult to get the medicine because of media coverage and I
panic every day I go to get my medicine, praying I will be able
to on that day get it filled,'' and so forth.
Are there people who would react more positively to, say,
OxyContin than another similar type of product so that the idea
of saying well, let us just take this one off the shelf and
leave similar products out there, are there people like Donna
Isaacs, who sent this--I presume I can use her name--that she
would not respond as well to a similar product?
Dr. Jenkins. Senator, in medicine it is often true that
drugs in the same class you will find a patient will respond to
one better than they will to another or alternatively, a
patient may have adverse reactions to one member of a class and
may have fewer or no adverse reactions to a similar member of
the class. We also have the issue of allergies.
So we generally believe that it is beneficial to have
choices for patients and physicians to go to when they are
trying to find the right treatment for the individual patient.
Senator Dodd. So the fact that there are serious addiction
problems here with this product obviously in places like my
friend from Virginia and my colleague from Maine and other
places around the country, it would not be your recommendation
that this product ought to be taken off the shelf.
Dr. Jenkins. We have not initiated any actions that would
result in OxyContin being removed from the market. As I said in
my testimony, we consider it to be a safe and effective product
when used according to its labeling to treat moderate to severe
pain.
Senator Dodd. You had some problem with the company. This
has been raised before. There was a letter that the FDA sent to
the company in May of 2000 regarding an advertisement they
sponsored that the agency felt was being promoted in a false
and misleading manner.
How often does the agency, FDA, send out these letters?
Dr. Jenkins. My understanding is that the agency sends
approximately 100 of those types of letters per year to
sponsors of marketed products.
Senator Dodd. And you told us here earlier the response was
a positive one from the company. Whatever the problem was, they
changed it immediately?
Dr. Jenkins. The company responded by withdrawing that
advertisement and we considered the issue to be closed.
Senator Dodd. Is that normally what happens with letters
like this?
Dr. Jenkins. The type of letter that was sent to the
company usually asks the company to withdraw the advertisement
and does not ask for any further action and that is what
happened in this case.
Senator Dodd. Is that normally what happens when letters go
out like that?
Dr. Jenkins. It often is what happens. Sometimes companies
will disagree with the FDA's judgment and will try to make
their case that the advertisement is not false or misleading
and will try to continue using that advertisement.
Senator Dodd. Last, Dr. Clark, I did not mean to avoid you
in all of this but I was trying to pull out the numbers on the
budgets because it really comes down to obviously this is a
serious issue to look at this particular product but I am
struck by the percentages. There are 1 million addicts of
opiods; is that correct?
Dr. Clark. That is the estimated number, yes, sir.
Senator Dodd. And we are treating about 20 percent of them;
is that not correct?
Dr. Clark. Yes, sir. Opiod-dependent addicts.
Senator Dodd. What is that?
Dr. Clark. Opiod-dependent.
Senator Dodd. That is what I said, opiod-dependent. About
20 percent of those.
Two questions. One, how large a role does the stigma
surrounding opiate addiction play in this particular low
percentile of people getting any kind of treatment? And second,
what sort of budget numbers are we talking about? I know that
there has been--and the president, to his credit, has talked
about trying to close the gap and so forth in this area but I
think our budget, $127 million for next year of a five-year
drug treatment initiative to replace the gap--is that the
number?
Dr. Clark. Yes, sir.
Senator Dodd. Overall, is that number adequate for
treatment of the addiction problems we face in this country,
particularly in this area?
Dr. Clark. Obviously the addiction problem is a
multifaceted and complex phenomenon. We are trying to--that
$127 million focuses on principally SAMHSA's budget but there
are other resources to address the issue of addiction within
the budgets of other agencies and one of the themes that
Secretary Tommy Thompson and Mr. Curry, who is the
administrator of the Substance Abuse Administration, wants to
make clear is that we partner with other agencies in the
department so that we can leverage the resources that we have.
Senator Dodd. My point is we spend billions of dollars in
going after interdiction and so forth, a lot of money is spent.
How much of that budget do we spend on treatment and is it
adequate in your view?
Dr. Clark. Well, clearly the whole budget process is a very
complex process.
Senator Dodd. I think I got my answer here.
Thank you, Mr. Chairman.
Senator Reed. Senator Warner?
Senator Warner. Thank you very much for participating in
this hearing. Your responses have been very well informed and I
commend you both for your service to mankind in your respective
positions.
Let us return to this reformulation issue raised by my
colleagues. Purdue Pharma, as my colleague Senator Dodd said,
is of good reputation and they certainly do not want to be
associated with the criminal element of this thing and I am
confident they are conscientiously doing everything they can in
this area of reformulation.
So my question to you, Dr. Jenkins, is it within the State
of the art to--you repeatedly used the word hope. Do you think
it is achievable?
Dr. Jenkins. Senator, there are other products on the
market that have the blocking agent added to try to avert the
abuse of the product. A classic example is a drug called Talwin
that was widely abused many years ago and the blocking agent
was added and the abuse of that product fell off remarkably.
The abuse of that product was primarily by intravenous
injection where the addition of the blocking agent could be
very effective.
The technology almost certainly exists to reformulate a
sustained release product to add the blocking agent and
maintain the effectiveness of the product in legitimate
patients. The concern I expressed is that it will not address
all of the problem.
Senator Warner. I understand but do you think that there is
a hope?
Dr. Jenkins. Yes.
Senator Warner. Is there any other prescription drug that
is being sold or has been sold in the past that was so heavily
abused soon after FDA approval?
Dr. Jenkins. Senator, first of all, the abuse of OxyContin
really started almost 5 years after the approval of the
product. It was approved in 1995 and the first reports started
coming in in about the year 2000 and the reports that we have
been receiving at the FDA really started increasing in the year
2001. So it took several years after that product was approved
before we started seeing widespread reports.
Whether we have seen more rapid abuse for other products, I
really cannot say at this time but it did take some time for
OxyContin to be widely abused.
Senator Warner. Last, Dr. Clark talked about the rural
identification with this problem and my colleague Senator
Collins and I both have these beautiful, pristine rural areas
of our State which are so heavily concentrated with this
problem, problems which we normally associate, I guess, with
the inner city and poverty and all the other unfortunate things
related to inner cities and here they are out in two of the
most beautiful parts of our respective States. Yet I can go a
bare 100 miles in one direction from this particular rural area
where we have a problem, which has been devastating
economically because of frankly the textile industry just being
driven out of our State and out of the United States, offshore,
yet there is not that problem.
Can anybody throw any light on why this happens? Can you
add anything? Then I will go back to Dr. Clark.
Dr. Jenkins. I really do not have an explanation for that
phenomenon, Senator. I think Dr. Clark may be more learned in
this area than I am on substance abuse.
Senator Warner. Dr. Clark, we will let you wrap up for this
panel.
Dr. Clark. Well, we are also dealing with a phenomenon
associated with pain. Initial access to OxyContin comes through
what we call the four P's--the pharmaceutical company, the
physician, the patients, as well as the pharmacies. All of them
play a role. Unlike drugs that you can make in your bathtub or
drugs you can grow in the field, this is a drug that comes from
very tightly controlled channels. What we clearly need is not
only the actions of the pharmaceutical company, which we have
heard about, physician education, but patient education, both
those who are addicts and those who are not addicts but have
shared their prescriptions for economic reasons, and that is
one of the things that we have heard, that there are people who
are forced for economic reasons that you described in terms of
the economic changes in the community, to share their
prescriptions with others and, in fact, receive compensation
for sharing those prescriptions, and then making sure that we
have adequate pharmacy safeguards.
Those are the things that will help those of us in
addiction treatment, help law enforcement to address those four
P's so that we can address this issue.
Senator Warner. Thank you very much.
Thank you, Mr. Chairman.
Senator Reed. Thank you.
Senator Dodd?
Senator Dodd. John, in response, there was a first-rate
story in yesterday's New York Times, the front page, that I am
sure many of you may have seen--``As drug use drops in big
cities, small towns confront upsurge.'' Just to quote in here,
it is a very good story, I thought, and it cites different
places. ``In Dawson County in Western Nebraska the problem is
methamphetamines. The percentage of meth-related crimes is
going through the roof. You are either stealing or dealing and
if you are not using, you are a cop.'' That is the quote of the
sheriff in that area.
``In the State as a whole, officials discovered 38
methamphetamine laboratories in 1999. Last year they discovered
179.''
John, they say one reason for the growth in rural drug
problems, Federal officials say, is that ``Aggressive
prosecution in cities has led dealers to seek safety in the
farms, forests of rural counties, which have far fewer law
enforcement officers. We have seen drugs and crime migrate to
rural areas in the past several years to get away from law
enforcement,'' and it goes on.
I do not know if that is the only reason but statistically
in rural areas we are seeing a significant increase and
actually a decline in some urban areas, but I thought maybe
having this article, Mr. Chairman, as part of the record might
be----
Senator Reed. Without objection, we will include that.
[The article follows:]
(The article was not available at press time, however, a
copy is maintained in the Committee files.)
Senator Reed. Thank you, gentlemen, very much. I would like
to call the next panel forward.
I welcome and thank this second panel. First, Dr. Richard
Payne. Dr. Payne heads the Sloan-Kettering Pain and Palliative
Care Service. He is a graduate of Yale University and the
Harvard Medical School. He has served on the faculty of the
University of Cincinnati Medical School. He has been Chief of
the Pain and Symptom Management Section and professor of
neurology at the University of Texas. He is currently the
President-elect of the American Pain Society, as well as an
editorial board member of the Journal of Pain. Thank you very
much, Dr. Payne, for joining us today.
Dr. Art Van Zee is a 1973 graduate of Case Western Reserve
University School of Medicine and is a board-certified internal
medicine physician with a specialization in geriatrics. In 1976
he served as the first full-time physician to the St. Charles
Clinic, a community-initiated clinic which has grown into a
federally funded health clinic serving five counties in
Southwest Virginia. He is a co-founder of the Lee Coalition for
Health and is an adjunct faculty member at East Tennessee State
University. Welcome, Dr. Van Zee.
I would now like to yield to my colleague, Senator Collins,
to introduce Ms. Nancy Green.
Senator Collins. Thank you, Mr. Chairman.
It is indeed a pleasure for me to introduce Nancy Green, a
certified nurse-midwife in private practice in Calais, ME. Ms.
Green is not only a health care provider; she is the president
of Neighbors Against Drug Abuse, a community organization
created in response to the OxyContin epidemic in Washington
County, Maine. She is also a registered alcohol and drug
counselor so she brings a number of valuable perspectives to
this debate and it is a great pleasure to welcome her to the
committee today.
Senator Reed. Thank you, Senator Collins.
Our next panelist is Lieutenant William R. Bess. Lieutenant
Bess has served in the Virginia Department of State Police
since October 1987. He is currently special agent in charge at
the Wytheville Field Office Drug Enforcement Division and prior
to that served in the Pharmaceutical Diversion Unit for 10
years. Lieutenant Bess has practiced law in Roanoke, VA for 10
years, served in the Chesterfield County Police Department and
is a veteran of the United States Marine Corps. Thank you very
much, Lieutenant, for joining us.
Dr. Paul Goldenheim joins us from Purdue Pharma, where he
currently serves as Executive Vice President of Worldwide
Research and Development and is currently responsible for the
research and development centers of Purdue Pharma and all its
associated companies in the United States, Canada, the United
Kingdom and Germany. Dr. Goldenheim received both his bachelors
and medical degrees from Harvard University and has served as
Clinical Director of the Pulmonary Unit at Massachusetts
General Hospital. Thank you for joining us today, Dr.
Goldenheim.
Again all of your statements will be fully included in the
record. You are urged to summarize. We have five panelists and
we have an eager and attentive group of senators who would like
to ask questions.
Dr. Payne?
STATEMENTS OF RICHARD PAYNE, M.D., CHIEF, PAIN AND PALLIATIVE
CARE SERVICE, DEPARTMENT OF NEUROLOGY, MEMORIAL SLOAN-KETTERING
CANCER CENTER, NEW YORK, NY; ART VAN ZEE, M.D., LEE COALITION
FOR HEALTH, ST. CHARLES, VA; NANCY GREEN, C.N.M., PRESIDENT,
NEIGHBORS AGAINST DRUG ABUSE, CALAIS, ME; LIEUTENANT WILLIAM R.
BESS, J.D., DRUG ENFORCEMENT DIVISION, VIRGINIA STATE POLICE,
WYTHEVILLE, VA; AND PAUL D. GOLDENHEIM, M.D., VICE PRESIDENT
FOR RESEARCH, PURDUE PHARMA, L.P., STAMFORD, CT
Dr. Payne. Thank you, Senator Reed. With that I would
actually like to go right into my statement.
I wish to emphasize in the strongest possible terms the
need to maintain balance in our drug regulatory policy so as to
improve the availability of essential opiod medications for the
treatment of pain while meeting our responsibility to control
drug diversion and elicit drug use. This point was emphasized
in a recent press conference back in October at which time a
position statement ``Promoting Pain Relief and Preventing Abuse
of Pain Medications: A Critical Balancing Act,'' was released
from 21 health care organizations and the Drug Enforcement
Administration. Mr. Hutchinson, the administrator of the DEA,
spoke at that press conference and acknowledged that the
achievement of a balanced approach to drug regulations was an
important objective of DEA policy. I have the statement here
and would like to introduce----
Senator Reed. Without objection, we will include it in the
record, Dr. Payne.
[The statement follows:]
(The statement was not available at press time, however, a
copy is maintained in the Committee files.)
Dr. Payne. I appeal for balance in drug policy because I am
keenly aware of the negative consequences for the care of
patients suffering from pain if the consequences of controlled
substance regulation further restricts access to essential pain
medications. I take this position for several reasons, which
are based on my own research work and experiences from 25 years
in clinical practice.
I wish to make several brief points. One, for many patients
opiod analgesics--morphine, oxycodone, Fentanyl patches, even
methadone, which can be administered for pain--are the most
effective way to treat pain of moderate to severe intensity and
often the only treatment that provides significant relief. My
clinical experience is quite consistent with the evidence-based
clinical practice guidelines widely published for the
management of pain, which emphasize the need for the
availability of multiple pain medications for clinicians so as
to enhance our ability to select the right drug for the right
patients, to speak to Senator Dodd's question earlier.
It is now very clear that with respect to the use of opiods
to manage pain, one drug does not fit all. In my cancer center,
for example, up to 15 to 20 percent of our patients require an
opiod drug other than morphine to provide the best pain relief
with the minimum number and intensity of side effects. In fact,
a study from our center reported that 80 percent of our
patients required at least one switch of opiod medications, 44
percent required two or more switches, and 20 percent required
three or more switches of opiod medications to get to the right
medication to manage their pain in the most optimal manner.
Even though opiods derived from the same general chemical
family, there are important clinical differences in the ways in
which patients respond to specific drugs. Patient A may not
tolerate morphine but will tolerate oxycodone while Patient B
may be just the opposite. Therefore, it is essential to have
many opiod medications available to clinicians.
Point two, OxyContin, a controlled release formulation of
oxycodone, is as effective as any other opiod for the treatment
of pain and has a similar profile of adverse effects, including
abuse liability. The well publicized cases of OxyContin abuse
are, in my opinion, related to the fact that it is so much more
widely prescribed and therefore more available to those with
criminal intent than other opiods. There is little data that
oxycodone per se has any inherently increased abuse liability
compared to morphine or other opiods.
The reason that OxyContin is so widely prescribed relates
in part to the fact that it is an effective alternative
medicine for patients who do not tolerate oral morphine and for
whom the other long-acting alternatives--Fentanyl patches or
methadone--are not good choices because of particular clinical
circumstances. Generally it's much easier to adjust the dose of
OxyContin to respond to the clinical needs of the patient in
comparison to the other available long-acting pain medications.
In my clinical practice these factors--the advantages, the
clinical advantages of high oral bioavailability, short half-
life, long duration of effect, predictable pharmacokinetics--
all of these factors have as much to do with the relative
popularity of OxyContin for the treatment of pain and much more
so than any marketing details by the pharmaceutical industry.
The third and final point, undertreatment of pain is a
serious problem for all Americans. Like other aspects of
medical care, patients from minority and poor communities
suffer from disparities in health care outcomes and are at
greater risk for undertreatment of pain than the general
population, at least 10 recent studies of documented
disparities in pain management for patients in minority
communities. For example, as reported in the New England
Journal of Medicine several years ago, 46 percent of patients
suffering from cancer were undertreated. Members of minority
groups had at least a threefold increased risk of
undertreatment within this group.
Similar racial and ethnically-based disparities in pain
treatment have been observed in emergency room treatments for
pain and in postsurgical pain management. Poor pain assessment
skills and, contrary actually to current opinions noted in the
media, an exaggerated fear of addiction by health care
providers are important reasons documented to drive this
undertreatment by physicians, particularly as it relates to
poor and minority patients.
A recent study published in the New England Journal of
Medicine reported that 72 percent of pharmacies in affluent and
nonminority areas of New York City stocked opiod drugs whereas
only 25 percent of pharmacies in poor and nonwhite communities
stock these drugs in New York City. So a major disparity in
terms of the pharmacies even carrying the drugs.
We have documented that this relative unavailability of
opiods in poor neighborhoods produces serious hardships and
increased suffering, especially for patients, families and
doctors managing terminal illnesses outside of the hospital.
Any drug regulations that further limit access to opiods,
OxyContin included, will particularly impact on these very
vulnerable patients.
So in summary, I wish to restate that we must pursue
policies that make pain management services and essential pain
medications equally available to all Americans. I join many of
my colleagues in pledging to work on strategies that ensure the
availability of essential opiod medications for pain while
incorporating ways to prevent their illicit diversion and
abuse. I thank the committee for hearing me.
Senator Reed. Thank you, Dr. Payne.
[The prepared statement of Dr. Payne follows:]
Prepared Statement of Richard Payne, M.D.
I thank you for the opportunity to speak with the Committee. My
name is Richard Payne. I am a physician with expertise in pain
management and palliative care, practicing at Memorial Sloan-Kettering
Cancer Center in New York City. In my capacity as Chief, Pain and
Palliative Care Service I see patients, teach medical students and
post-graduate physicians-in-training, and direct a program of pain and
palliative care research. I have also had the privilege to serve on The
Agency for Health Care Policy and Research (AHCPR) committees charged
with writing clinical practice guidelines for acute pain and I co-
chaired the cancer pain management panel. I have been a consultant to
the Institute of Medicine and the National Cancer Policy Board to
advise these agencies on the deficiencies of care provided to Americans
at the end of life, particularly on the disparities in pain management
and palliative care at the end of life care experienced by minority
patients. Although I am president-elect of the American Pain Society,
my appearance here today reflects my own personal views and not
necessarily the views of the American Pain Society.
I wish to emphasize, in the strongest possible terms, the need to
maintain balance in our drug regulatory policy so as to improve the
availability of essential opioid medications for the treatment of pain
while meeting our responsibility to control drug diversion and illicit
use of opioids. This point was emphasized in a recent press conference
(October 23, 2001) at which time, a position statement, ``Promoting
Pain Relief and Preventing Abuse of Pain Medications: A Critical
Balancing Act'' was released from 21 health care organizations and the
Drug Enforcement Administration. Mr. Asa Hutchinson, Administrator,
Drug Enforcement Administration (DEA) spoke at the press conference and
acknowledged that the achievement in of a balanced approach to drug
regulations was an important objective of DEA policy.
I appeal for balance in drug policy because I am keenly aware of
the negative consequences for the care of patients suffering from pain
if the consequences of controlled substance regulation further
restricts access to essential pain medications. I take this position
for several reasons, which are based on my own research work and
experiences from 25 years in clinical practice. I wish to make several
points:
Undertreatment of pain is a serious problem for all
Americans, and, like other aspects of medical care, patients from
minority and poor communities suffer from disparities in health care
outcomes and are at greater risk for undertreatment than the general
population. At least ten recent studies have documented disparities in
pain management for minority patients. For example, although as
reported in the New England Journal of Medicine several years ago,
although 46% of patients suffering with cancer-related pain were
undertreated, members of minority groups have at least a three fold
increased risk of undertreatment. Similar racial and ethnically-based
disparities in pain treatment have been observed in emergency room
treatments for trauma and in post-surgical pain management.
Poor pain assessment skills and--contrary to the current opinions
noted in the media--an exaggerated fear of addiction by health care
providers, are important reasons documented to drive this
undertreatment, particularly in minority patients. Another important
factor driving racial and ethnically-based disparities in pain
management is caused by a substantial problem with lack of availability
of essential opioid medications in poor and minority neighborhoods. For
example, a recent study published in the New England Journal of
Medicine (April 6, 2000) reported that 72% of pharmacies in white
neighborhoods of New York City stocked opioid drugs, whereas only 25%
of pharmacies in poor and non-white neighborhoods stocked opioids for
the treatment of pain. We have documented that this relative
unavailability of opioids in poor and minority neighborhoods produces
serious hardships and increased suffering, especially for patients,
families and doctors managing terminal illnesses outside of the
hospital. Drug regulations that further limit access to opioids will
particularly impact on these very vulnerable patients.
For many patients, opioid analgesics (e.g., morphine,
oxycodone, fentanyl patches, methadone) are the most effective way to
treat pain, and often the only treatment option that provides
significant pain relief.
My clinical experience is quite consistent with the evidence-based
clinical practice guidelines for the management of pain, which
emphasize the need for the availability multiple pain medications to
clinicians so as to enhance our ability to select the right drug for
the right patients. It is now very clear that with respect to the use
of opioids to manage pain, one drug does not fit all. In my cancer
center, up to 15-20% of our patients require a opioid drug other than
morphine to provide the best pain relief with the minimum number and
intensity of side effects. A study from Sloan-Kettering reported that
80% of patients required one switch of opioid medications; 44% of
patients required two or more switches and 20% of patients required
three or more switches of medication to manage their pain in the most
optimal manner. Even though opioids derive for the same general
chemical family, there are important clinical differences in the ways
in which patients respond to specific drugs--patient A may not tolerate
morphine, but will tolerate oxycodone, while patient B may be just the
opposite. Therefore, it is essential to have many opioid medications
available for clinicians--morphine, oxycodone, fentanyi, and
methadone--to provide the appropriate clinical flexibility that allows
optimization of therapy and individualization of the treatment of
patients.
OxyContin, a controlled-release formulation of
oxycodone, is as effective as any other opioid for the treatment of
pain, and has a similar profile of adverse effects, including abuse
liability, as other opioids. The well publicized cases of
OxyContin abuse are, in my opinion, related to the fact that
it is so much more widely prescribed-and therefore more available to
those with criminal intent--than other opioids. There is little data
that oxycodone per se has any inherently increased abuse liability
compared to morphine or other opioids. The reason that
OxyContin is so widely prescribed relates, in part, to the
fact that it is an effective alternative medication for patients that
do not tolerate oral morphine, and for whom fentanyl patches or
methadone are not good choices because of particular clinical
circumstances. Generally, it is much easier to adjust the dose of
OxyContin to respond to the clinical needs of the patient, in
comparison to the other available long-acting pain medications, such as
methadone or transdermal fentanyl (patches). In my clinical practice,
these clinical factors have as much to do with the relative popularity
of OxyContin@ for the treatment of pain, as did any marketing details
by the pharmaceutical industry. In summary, I wish to restate that we
must pursue policies that make pain management services and essential
pain medications equally available to all Americans. I join many of my
colleagues in pledging to work on strategies that ensure the
availability of essential opioid medications for pain while
incorporating ways to prevent their illicit diversion and abuse. I
thank the committee for hearing my statement.
Senator Reed. Dr. Van Zee?
Dr. Van Zee. Thank you very much for the opportunity to be
here today and present our viewpoint. I come to you as a
representative of a group called the Lee Coalition for Health,
a nonprofit group of professionals and community persons who
have for the last 10 years worked in Lee County, Virginia to
promote health and wellness issues. The last 2 years of our
efforts have been consumed by trying to help deal with the
OxyContin problems in our region.
In the 25 years I have practiced as a general internist in
St. Charles, which is a small Appalachian coal mining town,
there has never been anything to compare to the epidemic of
drug abuse and addiction that we have seen the last 3 years
with OxyContin. Contrary to what is sometimes portrayed in the
media as long-term addicts switching to the drug du jour, what
we have seen for the most part is numerous young people
recreationally using OxyContin and then becoming very rapidly
addicted. Many of these kids are good kids, good families with
bright, promising futures that are being destroyed in every way
by their opiod addiction.
Opiods, as derivatives of opium, are the most powerful pain
medication, with morphine being most familiar to you. OxyContin
addiction is opiod addiction, the same as morphine or heroin
addiction, and wrecks the same havoc on individuals, families
and communities. It is hard to find a family in Lee County that
has not been touched directly or indirectly by the problem of
OxyContin abuse. This is a sadly repetitive story for the
numerous areas of the country now affected by this, from
Washington County, Maine to Southern Florida.
My own personal view of the complicated OxyContin abuse
problem is that there are at least three major elements
involved. First, there has been an obvious problem with
physician misprescribing and overprescribing of this drug.
Second, this epidemic has been a vicious indicator of the
alarming degree of prescription drug abuse in our society.
Third and perhaps the one closest to this committee and the FDA
is that the promotion and marketing of OxyContin by Purdue
Pharma has played a major role in this problem.
Purdue Pharma, in the most extensive opiod promotion in the
history of the industry, has used sophisticated marketing data
to determine which physicians in the country prescribe opiods
most liberally and, in some cases, least discriminately and
coupled that data with lucrative financial incentives to their
sales representatives. One sales rep in Florida made $50,000 in
1999, $100,000 in 2000 over and above her $50,000 salary
because of the high OxyContin sales in her territory.
Purdue has used thousands of company-sponsored talks and
seminars, which are well shown in the medical literature to
influence and increase physician prescribing of a particular
product. Purdue heavily lobbied primary care physicians for the
use of OxyContin and primary care physicians traditionally have
had meager training in pain management and addiction issues.
The company used promotional free OxyContin pills for
patients and beach hats and music CDs for physicians. In
addition, Purdue engaged in an extensive and sophisticated
nonbranded promotion of opiods in general in which the benefits
of opiods for chronic, nonmalignant pain were much overstated
and the risk trivialized.
A testimony to the success of the promotional marketing
campaign is reflected in the fact that from 1996 to 2000 the
use of other commonly used opiods grew 23 percent while
OxyContin prescription dispensed during the same period
increased by over 1,800 percent. The fact that OxyContin does
not offer any major advantages over appropriate doses of other
opiods again is testimony to the success of Purdue's campaign.
The current regulations governing the way the
pharmaceutical industry can market and promote opiods or any
controlled drug has not served well the public health in this
situation. Not to drastically change these types of regulations
at this point would give sanction and safe harbor to the drug
companies for the continuation of such business practices,
which do not serve any of us well.
The Lee Coalition for Health nearly a year ago now
initiated a national petition to recall OxyContin until it can
be reformulated to a less abusable drug. The rationale for this
is as follows. We do have equally effective opiods for
treatment of severe pain. All Purdue-funded studies to date
have shown this; that is, that OxyContin is a good drug but not
a superior drug to what we have available. The medical letter
in September 2001 made similar conclusions and for nonmedical
people, the medial letter is kind of a gold standard for
prescribing physicians around the country in terms of assessing
drugs, their proper use, indications, benefits, and so on.
Some of the alternatives for OxyContin are much more cost
effective and some have less abuse potential than OxyContin.
Particularly in the light that we have equally effective opiods
to treat severe pain, it is clear that the pain and suffering
brought by the abuse of the drug far surpasses its benefits.
With the fastest growing epidemic of prescription drug abuse in
the United States in the last 25 years, all other measures
taken to stem the diversion and abuse will fall far short of
what is needed.
The recall of OxyContin is not a recall of opiods.
OxyContin is unique and its abuse unprecedented. The economics
of OxyContin diversion and abuse will now perpetuate this
disaster, regardless of the full array of measures taken to
stem the tide.
It is time Purdue Pharma did what Sterling Laboratories did
in 1983 when its narcotic was the source of increasing abuse,
addiction, medical complications and overdose deaths in the
country. It voluntarily recalled Talwin until it could be
reformulated to a preparation with much less abuse potential.
This is the end of my prepared comments. If there is any
time at the end, I would like to respond to why it has appeared
in some parts of the country and also about is this an isolated
problem or is this a national problem.
Senator Reed. Thank you, Doctor. You will have such an
opportunity.
[The prepared statement of Dr. Van Zee follows:]
Prepared Statement of Art Van Zee, M.D.
I come to you as a representative of a group called the Lee
Coalition for Health, a non-profit group of professionals and community
persons who have for the last ten years worked in Lee County, Virginia
to promote health and wellness issues. The last two years of our
efforts have been consumed by trying to help deal with the OxyContin
problem in our region.
In the 25 years I have practiced as a general internist in St.
Charles, a small Appalachian coal mining town, there has never been
anything to compare to the epidemic of drug abuse and addiction that we
have seen the last 3 years with OxyContin. Contrary to what is
sometimes portrayed in the media as long term drug addicts switching to
the drug du jour, what we have seen for the most part is numerous young
people recreationally using OxyContin and then becoming very rapidly
addicted. Many of these kids are good kids, good families, with bright,
promising futures that are being destroyed in every way by their opioid
addiction. Opioids--as derivatives of opium--are the most powerful pain
medication--with morphine being most familiar to you. OxyContin
addiction is opioid addiction, the same as morphine or heroin addiction
and wreaks the same havoc on individuals, families, and communities. It
is hard to find a family in Lee County that has not been touched
directly or indirectly by this problem of OxyContin abuse. This is a
sadly repetitive story for the numerous areas of the country now
affected by this from Washington County, Maine to southern Florida.
My own personal view of the complicated OxyContin abuse problem is
that there are at least three major elements involved. First, there has
been an obvious problem with physician mis-prescribing and over-
prescribing of this drug. Secondly, this epidemic has been a vicious
indicator of the alarming degree of prescription drug abuse in this
society. Thirdly, and perhaps the one closest to this committee and the
FDA, is that the promotion and marketing of OxyContin by Purdue Pharma
has played a major role in this problem.
Purdue Pharma, in the most extensive opioid promotion in the
history of the industry, has used sophisticated marketing data to
determine which physicians in the country prescribe opioids most
liberally (and, in some cases, least discriminately) and coupled that
data with lucrative financial incentives to their sales
representatives. One sales rep in Florida made $50,000 in 1999 and
$100,000 in 2000 in bonus incentives--over and above her $50,000 salary
because of the high OxyContin sales in her territory. Purdue used
thousands of company sponsored talks and seminars--well shown in the
medical literature to influence and increase physician prescribing of a
particular product. Purdue heavily lobbied primary care physicians for
the use of OxyContin--and primary care physicians traditionally have
had meager training in pain management and addiction issues. The
company used promotional free OxyContin pills for patients and beach
hats and music CDs for physicians. In addition, Purdue engaged in an
extensive and sophisticated non-branded promotion of opioids in
general--in which the benefits of opioids for chronic non-malignant
pain were much over-stated and the risks trivialized. A testimony to
the success of the promotional and marketing campaign is reflected in
the fact that from 1996 to 2000, the use of other commonly used opioids
grew 23% while OxyContin prescriptions dispensed during the same period
increased by over 1800%. The fact that OxyContin does not offer any
major advantages over appropriate doses of other opioids again is
testimony to the success of Purdue's campaign.
The current regulations governing the way the pharmaceutical
industry can market and promote opioids, or any controlled drug--has
not served well the public health in this situation. Not to drastically
change those types of regulations at this point would give sanction and
safe harbor to the drug companies for the continuation of such business
practices which do not serve any of us well.
The Lee Coalition for Health nearly a year ago now, initiated a
national petition to recall OxyContin until it can be re-formulated to
a less abusable drug. The rationale for this is as follows:
(1) we have available equally effective opioids for treatment of
severe pain. All Purdue funded studies to date have shown this--that
is, OxyContin is a good drug but not a superior drug to what we have
available. The Medical Letter (9/17/01) made similar conclusions. Some
of our alternatives are much more cost effective, and some have less
abuse potential than OxyContin;
(2) particularly in the light that we have equally effective
opioids to treat severe pain, it is clear that the pain and suffering
brought by the abuse of the drug far surpasses its benefits;
(3) that with this fastest growing epidemic of prescription drug
abuse in the U.S. in the last 25 years, all other measures taken to
stem the diversion and abuse will fall far short of what is needed;
(4) the recall of OxyContin is NOT a recall of opioids. OxyContin
is unique and its abuse unprecedented. The economics of OxyContin
diversion and abuse will now perpetuate this disaster regardless of the
full array of measures taken to stem the tide. It's time Purdue Pharma
did what Sterling-Winthrop Laboratories did in 1983 when its narcotic
was the source of increasing abuse, medical complications, and over-
dose deaths in the country. It voluntarily recalled Talwin until it
could be re-formulated to a preparation with much less abuse potential.
Thank you for the opportunity to speak to you today, and thank you
for your attention.
ATTACHMENT A
After the tragic national events of a few weeks ago, I know that
other problems facing the nation seem less consequential than they did
on September 10th. But I know that we do need to continue on in facing
that and other challenges for this country, and I do want to thank the
committee for the opportunity to present our views today on the
OxyContin abuse problem. I come to you as a representative of a group
called the Lee Coalition for Health, a non-profit group of
professionals and community persons who have for the last 10 years
worked in Lee County, Virginia to promote health and wellness issues.
The last two years of our efforts have been consumed by trying to help
deal with the OxyContin problem in our region.
For the last 25 years, I have practiced as a primary care general
internist in St. Charles, Virginia, a small coal mining town in
southwest Virginia. There has always been a certain back-ground level
of prescription drug abuse in the region, and a very limited amount of
opioid dependence. Opioids, as derivatives of opium--like morphine--are
our strongest pain medication available for patients with severe pain.
Unfortunately, opioids can for some people be the most addictive drug,
with heroin and morphine being the most well known in this context.
About two years ago we began to see rapidly increasing abuse and
addiction to OxyContin in southwest Virginia. OxyContin was being
snorted or injected IV, males and females, mid-teens to early forties.
We were seeing frequent overdoses, infections, occasional cases of
heart valve infections, and escalating Hepatitis C--a serious and
sometimes fatal liver infection transmitted by IV drug use. It is
anticipated that more HIV cases will follow. Many of these kids were
ones that I had held in my arms when they were babies, and had taken
care of their parents and their grandparents. Many of these
recreationally used OxyContin and had become rapidly addicted. The
addiction to OxyContin--as with any opioid--is similar to the more
familiar heroin addiction. Numerous young people were stealing from
their families and neighbors, and losing their jobs, vehicles, houses,
and sometimes their own children to this addiction. County sheriffs
throughout the region have estimated that 70-90% of all serious crimes
in the last two years have been drug related crimes, and most of that
OxyContin related. The number of children placed in foster care in Lee
County has increased 300% in the last three years, primarily related to
OxyContin abuse. In a school survey in May, 2000--in the Lee County
school system--9% of our 7th graders and 20% of our 12th graders had
used OxyContin. At our closest detox facility in Lebanon, Virginia,
they reported a 330% increase in the number of admissions that were
opioid dependent from 1996 to early this year. The Life Center of
Galax--about 3 hours drive from us--opened an out-patient methadone
maintenance treatment program in March, 2000--expecting about 12
patients in a year's time based on the prevalence of heroin addiction
in the region. They had 30 patients within 2 weeks of opening, and 254
patients within 8 months, and roughly 90% of these patients were
OxyContin dependent. A simple medical-social-legal picture has
unfortunately been seen in multiple areas throughout the country
related to OxyContin abuse. Methadone maintenance clinics in multiple
states have been filling up with OxyContin dependent patients.
The long term history of opioid addiction--whether it's heroin or
OxyContin addiction--is quite grim with long term statistics showing
high rates of illness, associated criminal activity, family
dissolutions, death rates and even with the best of treatments, a
significant life long relapse rate.
My own personal view of the complicated OxyContin abuse problem is
that there are at least three major elements involved: (1) the
increasing prevalence of prescription drug abuse in this country, both
by patients and by recreational users; (2) the mis-prescribing and
over-prescribing by a segment of the physician community; (3) and
lastly, and I think a major factor, the promotion and marketing
practices of Purdue Pharma, in regards to OxyContin and the use of
opioids in the treatment of chronic nonmalignant pain. I have included
in the attachments a detailed look at Purdue's promotion and marketing
as I see it. To focus in more clearly on the use of opioids in the
treatment of pain, I would submit that there is nothing at all
controversial in the medical community-at-large about the role or use
of opioids in acute severe pain (trauma, post-operative pain, kidney
stones, etc.) nor in the use of opioids--our strongest pain
medication--in the treatment of patients with cancer pain or other
terminal conditions. In those situations, the dose of opioids is
whatever it takes to provide comfort and compassionate care. The
particular issue of contention in the medical community-at-large
revolves around the precise role of opioids in the treatment of chronic
nonmalignant pain (not cancer related) and more specifically, the
surrounding issues of the therapeutic efficacy of opioids in this
situation, the adverse problem including side effects of opioids in
this situation, and probably most importantly, the risk of opioid
addiction and abuse. In the last decade, based on a few studies showing
some effectiveness for opioids in chronic non-malignant pain, there has
been a new willingness to review previous aversion to the use of
opioids in chronic non-malignant pain. There has been a wide spectrum
of opinion in the medical community up to the present about these
issues. One of the foremost leaders in this field, Dr. Russell Portenoy
at Memorial Sloan-Kettering Cancer Center in New York, concluded in his
1996 review of the topic--
``The available data do not support doctrinaire pronouncements
about the role of opioid therapy for nonmalignant pain. If
misconceptions about tolerance physical dependence, side
effects, and addiction can be eliminated, the clinician will
still be left with the challenging process of judging the
appropriateness of the approach in individual cases without the
benefit of a scientific foundation derived controlled clinical
trials. Controlled clinical trials of long-term opioid therapy
are needed, but lack of these trials should not exclude
empirical treatment when medical judgment supports it and
therapy is undertaken with appropriate monitoring.'' \1\
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\1\ Portenoy RK Opioid Therapy for Chronic Non-malignant Pain: A
Review of the Critical Issues J Pain Symptom Management 1996 Apr;
11(4):203-217.
In another comprehensive look at the issues, Dr. Dennis Turk
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concluded in 1996--
``At this particular point in time, decisions about the chronic
use of opioids appear to rely more on opinion appear to rely
more on opinion and clinical experience. The available data has
numerous flaws and is easily subject to interpretation both for
and against the use of opioids . . .'' in chronic nonmalignant
pain. \2\
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\2\ Turk DC Clinicians' Attitudes about Prolonged Use of Opioids. J
Pain Symptom Management 1996 Apr; 11(4):218-230.
What Purdue Pharma has done in their promotion and marketing of
OxyContin--and the use of opioids for chronic non-malignant pain in
general--is to enthusiastically over-state the benefits of opioids and
to trivialize the risks. A testimony to the success of the promotional
campaign is reflected in the fact that from 1996 to 2000, the use of
other commonly used opioids (codeine, hydrocodone, morphine, and
hydromorphone) grew 23% while OxyContin prescriptions dispensed during
the same period increased by over 1800%.\3\ The fact that OxyContin
does not offer any major advantages over appropriate doses of other
opioids \4\ again is testimony to the success of Purdue's campaign.
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\3\ Statistics, DEA, Office of Diversion Control.
\4\ The Medical Letter Sept. 17, 2001.
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Conventional wisdom in medicine is that if a drug is abusable, it
will be abused. By extension, if an abusable drug is widely available,
it will be widely abused. That has certainly been the experience with
OxyContin. The attached DEA map of OxyContin consumption in the United
States does show as expected that, by and large, those states with the
largest amount of OxyContin prescription purchases are the states
reporting the most extensive abuse. The map of Virginia clearly
reflects one of the major reasons why southwest Virginia has been so
hard hit with this problem. (The maps are maintained in the Committee
files) In some of our counties in the southwest, the OxyContin
consumption has been 500-700% higher than the national average! \5\
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\5\ Statistics DEA Office of Diversion Control.
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The Lee Coalition for Health in March of this year initiated a
national petition to recall OxyContin until it can be re-formulated to
a less abusable drug. The rationale for this has been as follows:
(1) that the pain and suffering brought to countless individuals
and communities by the abuse of this drug far exceeds the benefits of
the drug;
(2) that physicians can continue responsible treatment of acute and
chronic pain without the presence of OxyContin on the market. There are
no studies that show that this is a clearly superior drug. There are
equally effective opioids \6\ that can be used to treat patients for
their severe pain needs if OxyContin was recalled; and some of these
have less abuse potential than OxyContin;
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\6\ The Medical Letter Sept. 17, 2001
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(3) that with this fastest growing epidemic of prescription drug
abuse in the U.S. in the last 25 years, all other measures taken to
stem the diversion and abuse will fall far short of what is needed.
A large overlying issue in this whole thing, and one that falls
particularly under the realm of this committee, is that of the kind of
regulations that govern the pharmaceutical industry's marketing and
promotional practices. From my perspective, just as there is a very
real difference between non-controlled drugs and controlled drugs,
there needs to be much more stringent regulations about how the
industry can promote controlled drugs. I would submit that the use of
promotional items (e.g. beach hats and CDs); company sponsored meetings
and symposia; aggressive detailing by pharmaceutical reps; the use of
elaborate marketing data to influence physician prescribing of opioids;
web sites that promote opioid use--misrepresenting the benefits and
trivializing the risks--and the general non-branded promotion of
opioids in a variety of different ways--have not served well the public
health.
I would also propose to this committee to consider the possibility
of funding well designed, well controlled scientific studies--
independent of financial ties or obligations to the pharmaceutical
industry--that could bring much more light than heat to the controversy
about the real benefits and attendant risks in using opioids for
chronic nonmalignant pain.
I want to thank all of the committee for your attention and
interest in these matters of increasing national importance.
ATTACHMENT B
The OxyContin Abuse Problem: Spotlight on Purdue Pharma's Marketing
There appear to be at least three major factors which have played a
major role in the epidemic of OxyContin abuse which has affected so
many regions of the country. First, there has been an obvious problem
with physician mis-prescribing and over-prescribing of this drug.
Secondly, this epidemic has been a vicious indicator of the alarming
degree of prescription drug abuse in this society. Thirdly, the
promotion and marketing of OxyContin by Purdue Pharma has played a
major role in this problem. Below is a more detailed look at some of
these promotion and marketing practices.
1. Beach Hats and CDs
Long past the time last year when Purdue Pharma was aware of
rapidly increasing abuse, addiction, over-doses, and accelerating drug
related crime in certain regions of the country--the company was giving
out to physicians beach hats sporting the ``OXYCONTIN'' logo in bold
letters, CDs of swing music (``Swing in the Right Direction'') and
pedometers--OxyContin--``A step in the right direction''. While Purdue
has since stopped this kind of promotion amidst a barrage of criticism,
it is reflective of their attitude, marketing, and promotion.
2. Pain Management Talks and Seminars
In recent years, Purdue brought in 2,000 to 3,000 doctors to three
day retreats in Arizona, California, and Florida for company sponsored
work-shops on pain management. Some of these physicians were then
recruited by Purdue to serve as paid speakers at Purdue sponsored
medical meetings.\1\ It is well documented that this type of
pharmaceutical company sponsored symposia very significantly influence
physician prescribing even though the physicians who attend such
symposia believe that such enticements do not alter their prescribing
patterns.\2\
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\1\ New York Times, March 5, 2001 ``Use of Painkiller Grows
Quickly, Along with Widespread Abuse''.
\2\ Orlowski JP The Effects of Pharmaceutical Firm Enticements on
Physician Prescribing Patterns. Chest 1992; 102(1l):270--3.
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Additionally, Purdue sponsored an estimated 7,000 ``pain
management'' seminars around the country--stressing the importance of
aggressive treatment of pain with an enthusiastic emphasis on opioids
for chronic non-malignant pain.
3. Other Targeted Marketing and Promotion to Physicians
It is well documented that drug companies compile ``prescriber
profiles'' on individual physicians--detailing the prescribing patterns
of physicians nation-wide--in an effort to influence or sway doctors'
prescribing habits. Through the profiles, a particular drug company can
identify the highest and lowest prescribers of a particular medicine in
a single zip code, county, state or the entire country.\3\ Purdue
acquired from I.M.S. Health, a leading pharmaceutical market research
company, the information of which physicians prescribed the largest
numbers of opioids.\4\ This information would apparently prove quite
useful in the company's attempt to influence physicians' prescribing
habits nation-wide.
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\3\ New York Times Nov 16, 2000 ``High-Tech Stealth Being Used to
Sway Doctor Prescriptions''.
\4\ Personal meeting--Lee Coalition for Health with Purdue Pharma,
March 26, 2001 information by Michael Friedman, Exec VP, Purdue.
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4. Purdue and the Marketplace--Creating the Demand
Over the last 15 years, there has been a substantial change in the
medical community in regards to many issues concerning pain and pain
management. There was increasing attention paid to improving the
treatment of pain not only with acute pain and cancer related pain, but
with chronic non-malignant pain. There was increased attention by pain
management specialists on the role of opioids in all three of these
clinical situations. There were small and limited studies that
suggested that there might be a rate for opioids, in chronic non-
malignant pain in selective patients. Purdue Pharma not only recognized
the changing clinical land-scape, but saw this as a business
opportunity. Purdue, which had introduced a sustained-release
morpbine--MS Contin--in 1985 for the treatment of cancer pain, began to
promote MS Contin for noncancer pain as well.
Purdue's promotion and marketing of MS Contin did result in a
strong ``Warning Letter'' from the FDA in 1996--''. . . we have
concluded that Purdue is disseminating promotional materials for MS
Contin that contain statements, suggestions, or implications that are
false or misleading in violation of the Federal Food, Drug, and
Cosmetic Act. . . . This violation is occurring despite repeated
notification to Purdue by DDMAC that claims of product superiority were
unsupported and were false and/or misleading and in violation of the
Act.'' \5\
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\5\ FDA letter to Dr. Richard Sackler, President, Purdue--available
for review on the FDA web site.
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Purdue actively promoted to patients and doctors that unmet pain
needs were of epidemic proportion; that it was much more treatable than
had been previously thought; and that in many cases, it could, and
should, be treated with opioids. Purdue contributed generously to
patient-advocacy organizations, including the American Pain Foundation,
the National Foundation for the Treatment of Pain and the American
Chronic Pain Association.\6\ In Canada, Purdue has co-sponsored the
``Patient Pain Manifesto''--recently announced by the Canadian Pain
Society--which calls for a ``Bill of Rights'' for patients and their
families regarding pain treatment.\7\ Through its web-site ``Partners
Against Pain'' Purdue consistently over-stated the benefits of opioids,
in chronic non-malignant pain while trivializing the risks,
particularly the risks of addiction. (see attached documentation--
``Partners Against Pain'' by this author)--All of the above mentioned
direct and indirect marketing and promotion for the liberalization of
the use of opioids in chronic non-malignant pain raises a multitude of
serious questions for the medical community in general, the pain
management community in particular, for the FDA which is charged in
part with regulation of the pharmaceutical industry for the protection
of the public health, and for the DEA which is left with having to deal
with so much of the difficulties of a catastrophe like this--whether it
is the amphetamine disaster of a few decades ago, or the tragic
OxyContin disaster now.
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\6\ New York Times Magazine July 29, 2001 ``The Alchemy of
OxyContin: From Pain Relief to Drug Addiction''.
\7\ Greg Woods reports, Wednesday, June 6, 2001.
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While no experienced practitioner of medicine or any student of the
issues involved would suggest that there is never a place for opioids
in chronic non-malignant pain, the issues in contention revolve around
how selective one needs to be in initiating treatment with opioids for
chronic non-malignant pain, and what the risks are of addiction. Dr.
Russell Portenoy, an expert of international eminence in these issues
and an advocate for opioid therapy in very selected patients with
chronic non-malignant pain, wrote in his review of the subject in
1996--``The limited number of controlled trials, combined with
disparities and inherent biases of the survey literature, preclude
definitive conclusions about the risks and benefits of long-term opioid
therapy. Nonetheless, it is reasonable to infer from these conflicting
results that there is a spectrum of patient responses. On one end of
this spectrum is a ``successful'' subpopulation that achieves sustained
partial analgesia, without the development of treatment-limiting
toxicity, functional deterioration, or aberrant drug-related behaviors.
Some of these patients achieve functional gains as pain declines. On
the other end is a subpopulation that deteriorates during opioid
therapy. This deterioration can be characterized by worsening pain and
disability, the development of aberrant drug-related behaviors, or
both.''
``Most pain specialists, endorse this view of opioid therapy and,
consequently, no longer debate the role of opioid therapy in absolute
terms. For pain specialists, the issue is not whether opioid drugs
should ever be used in the treatment of chronic pain, but when and how.
Although this shift in consensus may not be shared by all specialists,
and has certainly not disseminated widely to other professional
disciplines, it is noteworthy, and suggests that the use of opioid
therapy for chronic non-malignant pain must now be evaluated as a
potentially salutary therapeutic option for carefully selected
patients. From this vantage, all those who might become involved in
this therapy--clinicians, pharmacists, regulators, and patients--could
benefit from a clear understanding of the evidence that defines its
risks and benefits.'' \8\
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\8\ Portenoy RK ``Opioid Therapy for Chronic Nonmalignant Pain:
Clinicians' Perspective'' J Law Med Ethics 1996 Winter; 24(4):296-309.
---------------------------------------------------------------------------
Unfortunately, since Dr. Portenoy's published article in 1996--
citing the scientific literature's inability to make definitive
conclusions about the risks and benefits of long-term opioid therapy,
and advocating opioid therapy for carefully selected patients--there is
not any further articles in the literature which would provide for the
medical community more recent data that would define more clearly what
the risks and benefits are of long-term opioid therapy in this
population. That lack of good data has not hindered the enthusiasm of
Purdue's marketing and promotion. Never has long term opioid therapy
received such promotion--direct and indirect-by the pharmaceutical
industry, as mentioned above. And never have the primary care
physicians--whose back-ground in pain and addiction issues have
admittedly been sub-optimal--been so targeted in the promotion of an
opioid as they have by Purdue Pharma and OxyContin. The success of the
promotional campaign was reflected in the fact that from 1996 to 2000,
the use of other commonly used opioids (codeine, hydrocodone, morphine,
and hydromorphone) grew 23% while OxyContin prescriptions dispensed
during the same period increased by over 1800%.\9\ The fact that there
are no studies in the medical literature demonstrating clear-cut
superiority over older preparations such as sustained release morphine
makes the promotion and marketing an even greater commercial success
for Purdue Pharma.
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\9\ Statistics, DEA, Office of Diversion Control.
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Personal Conclusions
1. I would re-iterate that I feel there are at least three major
factors involved in the OxyContin abuse epidemic--physician mis-
prescribing and over-prescribing; the alarming prevalence of
prescription drug abuse in this country; and the promotion and
marketing practices of the maker of the drug, Purdue Pharma.
2. Clearly most of the regions of the country that are most
affected by the OxyContin abuse epidemic have been the areas of the
country where it was simply most available, i.e., where it was
prescribed in unusually large amounts.\10\ This re-inforces the old
observation that if a drug can be abused, it will be abused. And
simply, by extension, if an abusable drug is widely available, it will
be widely abused.
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\10\ U.S. map of OxyContin consumption by state, DEA, Office of
Diversion Control.
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3. I would hope that several concrete changes can come out of what
has been learned from the OxyContin abuse epidemic.
(A) It would be my hope that there is a change in the regulations
that govern the pharmaceutical industry's marketing and promotional
practices. Just as there is a very real difference between non-
controlled drugs and controlled drugs, there needs to be a very real
difference in regulations for how pharmaceutical companies can promote
and market controlled drugs versus non-controlled drugs. The existing
regulations have not served the public health well.
(B) Hopefully, with available technology, it would be a standard in
the pharmaceutical industry that any marketed opioid would need to be
formulated so as to minimize the abuse potential--as in the Talwin/NX
story or with Purdue's current efforts to re-formulate sustained
release oxycodone with naltrexone. It can be done with available
technology, it will be done, and hopefully this will become an
expectation and standard for the marketing of any opioid in the future.
``partners against pain''
On the ``Partners Against Pain'' web-site sponsored by Purdue
Pharma, there is frequent mis-representation of facts that--when taken
as a whole--tend to falsely over-sell the benefits and trivialize the
risks in the use of opioids for chronic non-malignant pain. Examples
follow.
From--``Patient/Caregiver'' menu
``There are 75 million Americans living with pain, although pain
management experts say they don't have to. And the statistics on the
cost of pain in America are alarming.'' . . . 3 paragraphs later . . .
``With the treatments available today, experts say we do not have to
live in pain. An array of effective therapies, ranging from relaxation
and physical therapies, to prescription pain medications, such as
opioid analgesics, can help meet the needs of patients who suffer from
various degrees of pain.''
Reality: Opioids are the strongest pain medication available and can
alleviate severe pain effectively for many patients. Opioids do not
eliminate pain. For medication treatment of pain, it would be
customary of good medical practice to use a step approach,
beginning with non-controlled drugs and, in quite select
circumstances, advance to opioids if needed for severe pain.
``In addition, education programs such as Partners Against Pain,
play a central role in offering the latest information on pain
treatment at the grassroots level.
``Neil Irick, M.D., a noted pain expert in Indianapolis, added--
``Educational efforts such as Partners Against Pain, which
inform patients and physicians about the latest developments in
pain management, coupled with the new JCAHO standards, form the
cornerstone of providing all patients with the very best pain
care available, regardless of where they are being treated.''
Reality: The above gives false reassurance to the patient and caregiver
that this is a reliable, non-biased, non-commercial educational
site. Dr. Irick has been a paid speaker for Purdue including being
featured in promotional videos for Purdue.
Under `Pain Killers'
``Recently, however, pain has begun to emerge as a treatable entity
in its own right with doctors who specialize in pain management. There
are also several methods for enhanced medication delivery including the
now ubiquitous patient controlled analgesia (PCA), transdermal opioid
patches, and time-release opioids that can be taken as few as two times
a day. Another avenue pain specialists pursue is to try `adjuvant'
medications which are approved for uses other than pain but are
effective in treating pain (e.g., epilepsy drugs, clonidine). Despite
these advances, pain is often left untreated or undertreated for long
periods of time before patients find an appropriate doctor and adequate
treatment. Unfortunately, pain that is chronically untreated or
undertreated may lead to further complications such as poor healing,
depression, and immunosuppression. . . .''
Reality: A stepped approach for pain medication has been the standard
in medicine, beginning with drugs with the least potential side
effects and progressing if needed in certain patients to controlled
drugs, opioids. The patient or caregiver reading the above would
not get an accurate view of the customary approach to medication
treatment of chronic pain.
From the ``Professional Education'' Menu
``Opioids for Chronic Nonmalignant Pain''
``Recent studies (mostly case studies) have shown that chronic pain
patients can take opioids on a long-term basis with favorable results.
These studies show that pain reduction was better in patients who used
morphine while their functional and cognitive status remained the same.
Additionally, with acceptable compliance, patients showed an
improvement in pain control which led to an increased amount of
activity without excessive tolerance to the selected opioid. It is
important for the health care practitioner to keep in mind that some
patients may not experience complete relief. It is imperative that
physicians inform their patients about their responsibilities when they
are prescribed opioids for pain management. The author suggests the use
of an agreement form which makes the patient's responsibilities
unambiguous.'' (Belgrade MJ. Postgraduate Medicine 1999:; 106(6): 115-
124)
Reality: Going directly to the original article, on finds that Belgrade
indicates that it is a ``new myth'' that `Addiction almost never
occurs when opioids are used for pain control.' He goes on to say
that ``Although opioids themselves may not cause addiction, the
high prevalence of addiction in the general population and the even
higher comorbidity of addictive disorders with psychiatric illness
mean that a substantial minority of patients with chronic pain
treated with opioids display problem behavior that make opioid
management arduous, if not impossible. The proportion of problem
cases appears to be 10-15% of patients with chronic pain selected
for opioid maintenance analgesia.''
From ``Opioid Analgesia'' an Essential Tool in Chronic Pain''
``Opioid therapy in chronic malignant and non-malignant pain is
beneficial and safe for most people. This article suggests that by
following a few basic guidelines, physicians can help patients in pain
realize that pain is avoidable.''
Reality: These statements over-state the benefits and falsely under-
estimate the risks of opioids for chronic non-malignant pain.
From ``Opioids and Back Pain: The Last Taboo''
``When will we recognize the role of opioids in chronic back pain?
That's a question that more and more medical professionals are asking,
as the media focuses new attention on the sad fact that back pain
remains poorly controlled.''
``Responsibly used, opioids can improve care for selected patients
with back pain. But many people still have the out-dated attitude that
opioids are taboo in back pain because they `create' addicts. While
opioids can be abused and may be habit forming, clinical experience
shows that `addiction' to opioids legitimately used in the management
of pain is very rare . . . in trials in almost 25,000 patients with no
history of drug dependence, there were only 7 cases of iatrogenic drug
dependence, there were only 7 cases of iatrogenic drug addiction.''
Reality: Tracing back to original literature, the above figure comes
from 3 separate studies summarized below.
(1) not a study, but a letter to the editor NEJM by J. Porter
and H. Jick, 1980, Jan 10; 302(2): 123--reported that of 11,882
patients who received at least one narcotic preparation while
hospitalized, there were only four cases of reasonably well
documented addiction.
(2) Perry S. ``Management of Pain during Debridement: a Survey
of U.S. Burn Units'' Pain 13 (1982) 267-280.
--a questionnaire survey of 151 U.S. burn units, regarding
analgesic practices for debridement.
--10,000 patients--``not one case of actual iatrogenic
addiction could be documented. The 22 patients reported to
abuse drugs after discharge all had a prior history of drug
abuse''.
(3) Medina J. ``Drug Dependency in Patients with Chronic
Headaches'' Headache, March, 1977, 12-14.
--review of 2,369 patients seen in their clinic with headaches
1975-1976--only 62 patients were actually included in the
study; of these only 23 were taking narcotics (propoxyphene or
codeine) and of the 23, three were felt to be abusers of their
medication.
Reality: These studies are quoted on the web site, in literature given
to physicians (e.g. ``Dispelling the Myths about Opioids''), and in
literature given to patients who take OxyContin. The reality is
that these citations are all in patients who have been exposed to
opioids in the acute care pain situation, most hospitalized. They
do not give a meaningfull assessment of the risks of addiction for
patients taking opioids for chronic non-malignant pain.
Dr. Russell Portenoy, an expert of international eminence and an
advocate for opioid therapy in very selected patients with chronic non-
malignant pain, in reviewing these studies stated ``It must be
emphasized, however, that neither this observation nor any of the data
described previously directly assesses the risk of addiction among
chronic nonmalignant pain patients administered opioids for prolonged
periods.'' Portenoy RK ``Chronic opioid therapy in nonmalignant pain''
J Pain Symptom Manage 1990 Feb; 5(1 suppl): S46-62.
Personal Conclusions
The above review of Purdue Pharma's ``Partners Against Pain''
website does not purport to be a comprehensive review. However, what is
reviewed, I would conclude, does reflect that Purdue through this
website has for physicians and patients over-sold the benefits of
opioid therapy for chronic non-malignant pain, while providing false
reassurance about what the real risks are of addiction for patients
taking opioids for chronic non-malignant pain.
ATTACHMENT C--OXYCONTIN CONSUMPTION PER 100,000 POPULATION--JANUARY-
DECEMBER, 2000--USA & VIRGINIA
DEPARTMENT OF JUSTICE--DRUG ENFORCEMENT ADMINISTRATION--ARCOS 2--REPORT
4--CUMULATIVE CONSUMPTION IN GRAMS PER 100,000 POPULATION
Reporting Period: 01/01/2000 to 12/31/2000
------------------------------------------------------------------------
Drug name: OxyContin
-------------------------------------------------------------------------
Grams/100K
Rank State Population Grams to date Pop. to date
------------------------------------------------------------------------
1..... ALASKA.......... 637,786 52,956.66 8,303.20
2..... WEST VIRGINIA... 1,834,977 149,287.45 8,135.66
3..... FLORIDA......... 15,123,712 1,135,140.96 7,505.70
4..... MAINE........... 1,254,228 87,938.59 7,011.37
5..... MISSOURI........ 5,519,767 378,785.99 6,862.35
6..... CONNECTICUT..... 3,284,638 219,394.44 6,679.41
7..... NEW HAMPSHIRE... 1,215,820 80,748.41 6,641.48
8..... PENNSYLVANIA.... 12,196,657 741,776.32 6,081.80
9..... DELAWARE........ 762,928 45,679.15 5,987.35
10.... KENTUCKY........ 3,983,524 227,718.40 5,716.51
11.... SOUTH CAROLINA.. 3,842,027 212,139.37 5,521.55
12.... MARYLAND........ 5,256,181 289,561.06 5,508.96
13.... OHIO............ 11,308,118 610,639.43 5,400.01
14.... ALABAMA......... 4,434,285 235,440.62 5,309.55
15.... RHODE ISLAND.... 997,867 52,238.45 5,235.01
16.... MASSACHUSETTS... 6,191,180 319,220.82 5,156.06
17.... NEVADA.......... 1,837,560 92,588.43 5,038.66
18.... ARIZONA......... 4,732,567 235,103.17 4,967.77
19.... WASHINGTON...... 5,817,823 257,019.97 4,417.80
20.... OREGON.......... 3,369,788 148,379.53 4,403.23
21.... NORTH CAROLINA.. 7,723,277 339,758.19 4,399.15
22.... VERMONT......... 613,933 25,920.94 4,222.11
23.... VIRGINIA........ 6,960,521 292,844.70 4,207.22
24.... MICHIGAN........ 9,670,334 375,023.55 3,878.08
25.... GEORGIA......... 7,811,632 302,894.25 3,877.48
26.... NEW JERSEY...... 8,158,375 312,519.06 3,830.65
27.... INDIANA......... 6,023,368 225,414.48 3,742.33
28.... LOUISIANA....... 4,419,367 161,829.82 3,661.83
29.... MISSISSIPPI..... 2,806,081 102,563.29 3,655.04
30.... TENNESSEE....... 5,598,896 197,738.81 3,531.75
31.... WISCONSIN....... 5,309,409 185,332.92 3,490.65
32.... MONTANA......... 942,485 31,910.26 3,385.76
33.... UTAH............ 2,172,245 72,257.59 3,326.40
34.... DISTRICT OF 527,376 16,640.36 3,155.31
COLUMBIA.
35.... HAWAII.......... 1,250,999 38,878.69 3,107.81
36.... ARKANSAS........ 2,618,315 76,300.57 2,914.11
37.... OKLAHOMA........ 3,365,270 96,736.33 2,874.55
38.... IDAHO........... 1,325,236 34,888.00 2,632.59
39.... COLORADO........ 4,126,972 106,250.36 2,574.54
40.... NEW MEXICO...... 1,839,278 41,398.41 2,250.80
41.... KANSAS.......... 2,659,522 58,835.21 2,212.25
42.... MINNESOTA....... 4,806,626 102,590.70 2,134.36
43.... NEBRASKA........ 1,698,165 35,247.47 2,075.62
44.... TEXAS........... 19,989,625 413,683.05 2,069.49
45.... CALIFORNIA...... 32,432,678 637,119.27 1,964.44
46.... NORTH DAKOTA.... 659,786 12,725.82 1,928.78
47.... SOUTH DAKOTA.... 772,409 14,177.88 1,835.54
48.... WYOMING......... 520,976 8,982.15 1,724.10
49.... IOWA............ 2,895,100 47,791.65 1,650.78
50.... NEW YORK........ 18,154,793 282,320.23 1,555.07
51.... ILLINOIS........ 12,030,766 156,076.10 1,297.31
52.... PUERTO RICO..... 3,915,798 9,653.60 246.53
53.... VIRGIN ISLANDS.. 119,827 155.22 129.54
54.... TRUST 228,400 8.95 3.92
TERRITORIES.
-----------------------------------------------
U.S. TOTAL.......... 277,749,273 10,388,225.10 3,740.14
------------------------------------------------------------------------
THE RELEASE OF INFORMATION SUBJECT TO DEA APPROVAL.
STATE OF VIRGINIA BY COUNTY
2000 OxyContin Consumption Per 100K Population
----------------------------------------------------------------------------------------------------------------
Sorted by: Grams Per 1OOK
-----------------------------------------------------------------------------------------------------------------
County Population Total Grams Grams Per 100K
----------------------------------------------------------------------------------------------------------------
Dickenson.................................................... 16,061 4,143.85 25,800.70
Lee.......................................................... 21,931 5,131.10 23,396.56
Buchanan..................................................... 29,262 5,599.82 19,136.83
Scott........................................................ 22,761 4,170.85 18,324.55
Roanoke City................................................. 80,893 14,344.04 17,732.12
Tazewell..................................................... 45,273 7,757.23 17,134.34
Winchester City.............................................. 23,458 3,575.65 15,242.77
Manassas City................................................ 40,081 5,905.64 14,734.26
Fauquier..................................................... 57,972 8,344.94 14,394.78
Wythe........................................................ 26,770 3,810.82 14,235.41
Wise......................................................... 45,938 6,265.65 13,639.36
Roanoke...................................................... 110,067 14,830.34 13,473.92
Pulaski...................................................... 50,924 6,094.35 11,967.54
Russell...................................................... 29,423 3,471.04 11,797.03
Falls Church City............................................ 15,115 1,619.46 10,714.26
Giles........................................................ 16,883 1,706.81 10,109.64
Fredericksburg City.......................................... 22,284 2,103.65 9,440.18
Bland........................................................ 7,032 519.63 7,389.51
Orange....................................................... 21,617 1,574.83 7,285.15
Richmond City................................................ 128,156 9,043.45 7,056.60
Loudoun...................................................... 162,766 10,127.12 6,221.89
Washington................................................... 50,142 3,074.81 6,132.20
Montgomery................................................... 76,323 4,654.45 6,098.36
Smyth........................................................ 31,875 1,904.88 5,976.09
Botetourt.................................................... 22,188 1,151.96 5,191.82
Portsmouth City.............................................. 98,311 4,971.43 5,056.84
Prince William............................................... 274,516 12,965.87 4,723.17
Bristol City................................................. 16,066 751.25 4,676.02
Fairfax...................................................... 969,354 45,285.94 4,671.76
Isle of Wight................................................ 28,778 1,228.86 4,270.14
Gloucester................................................... 35,057 1,448.94 4,133.10
Poquoson City................................................ 11,590 462.08 3,986.89
Bedford...................................................... 96,262 3,825.81 3,974.37
Warren....................................................... 27,268 1,077.91 3,953.02
Franklin..................................................... 44,303 1,732.96 3,911.61
Lancaster.................................................... 11,502 433.79 3,771.43
Page......................................................... 22,838 846.28 3,705.58
Alleghany.................................................... 22,670 801.38 3,534.98
Louisa....................................................... 29,877 1,010.48 3,382.13
Augusta...................................................... 107,884 3,637.04 3,371.25
James City................................................... 66,773 2,190.57 3,280.62
Newport News City............................................ 184,149 5,888.73 3,197.81
Henry........................................................ 69,158 2,175.01 3,144.99
Henrico...................................................... 307,243 9,620.00 3,131.07
Hanover...................................................... 84,301 2,617.52 3,104.97
Patrick...................................................... 16,719 480.38 2,873.26
Williamsburg City............................................ 1,162 32.82 2,824.44
Hampton City................................................. 142,549 3,861.27 2,708.73
Grayson...................................................... 30,508 821.58 2,693.00
Southampton.................................................. 27,392 722.17 2,636.43
Spotsylvania................................................. 88,917 2,308.38 2,596.11
Chesterfield................................................. 315,728 8,148.37 2,580.82
King William................................................. 16,957 433.47 2,556.29
Richmond..................................................... 9,028 230.14 2,549.18
Lynchburg City............................................... 58,240 1,467.29 2,519.39
Rockbridge................................................... 33,263 820.39 2,466.37
York......................................................... 44,035 1,025.41 2,328.62
Pittsylvania................................................. 108,653 2,527.73 2,326.42
Accomack..................................................... 32,471 728.30 2,242.92
Alexandria City.............................................. 120,636 2,634.43 2,183.78
Suffolk City................................................. 65,617 1,428.21 2,176.59
Nottoway..................................................... 16,149 349.26 2,162.73
Amherst...................................................... 29,579 597.22 2,019.07
Mecklenburg.................................................. 31,390 632.65 2,015.45
Cumberland................................................... 18,025 357.27 1,982.08
Arlington.................................................... 180,826 3,523.79 1,948.72
Chesapeake City.............................................. 211,847 4,019.92 1,897.56
Stafford..................................................... 94,093 1,774.74 1,886.16
Prince George................................................ 65,072 1,197.89 1,840.87
Culpeper..................................................... 36,983 676.60 1,829.49
Appomattox................................................... 10,714 194.32 1,813.70
Rockingham................................................... 93,552 1,676.05 1,791.57
Greensville.................................................. 16,826 289.25 1,719.07
Essex........................................................ 9,533 162.92 1,709.01
Westmoreland................................................. 16,457 274.90 1,670.41
Shenandoah................................................... 35,438 578.37 1,632.06
Albemarle.................................................... 115,999 1,849.51 1,594.42
Carroll...................................................... 23,503 374.20 1,592.14
Mathews...................................................... 9,852 150.45 1,527.10
Clarke....................................................... 13,648 202.40 1,483.00
Frederick.................................................... 57,113 826.67 1,447.43
Norfolk City................................................. 209,101 2,939.91 1,405.98
Middlesex.................................................... 10,539 138.61 1,315.21
Virginia Beach City.......................................... 441,859 5,795.74 1,311.67
Buckingham................................................... 19,318 253.22 1,310.80
Lunenburg.................................................... 12,489 153.93 1,232.52
Sussex....................................................... 13,281 157.55 1,186.28
Halifax...................................................... 36,475 395.66 1,084.74
Floyd........................................................ 12,120 121.63 1,003.55
Bath......................................................... 5,467 54.60 998.72
Caroline..................................................... 22,379 203.29 908.40
Radford City................................................. 1,437 11.35 789.84
Rappahannock................................................. 8,069 63.58 787.95
Goochland.................................................... 15,387 119.98 779.75
Madison...................................................... 10,552 76.06 720.81
Northampton.................................................. 12,733 87.67 688.53
New Kent..................................................... 15,871 103.79 653.96
Northumberland............................................... 11,771 76.04 645.99
Powhatan..................................................... 22,289 140.48 630.27
King George.................................................. 18,275 111.86 612.09
Charlotte.................................................... 10,203 58.13 569.73
Amelia....................................................... 10,035 51.02 508.42
Fluvanna..................................................... 18,224 89.45 490.84
Dinwiddie.................................................... 17,189 70.73 411.48
Campbell..................................................... 44,705 181.67 406.38
Brunswick.................................................... 16,983 55.46 326.56
Nelson....................................................... 17,300 47.39 273.93
Greene....................................................... 15,249 8.96 58.76
Charles City................................................. 6,709 0.00 0.00
Craig........................................................ 6,180 0.00 0.00
Fairfax City................................................. 859 0.00 0.00
Harrisonburg City............................................ 3,369 0.00 0.00
Highland..................................................... 2,487 0.00 0.00
King and Queen............................................... 6,407 0.00 0.00
Manassas Park City........................................... 1,730 0.00 0.00
Martinsville City............................................ 2,653 0.00 0.00
Petersburg City.............................................. 1,460 0.00 0.00
Prince Edward................................................ 11,872 0.00 0.00
Surry........................................................ 5,926 0.00 0.00
--------------------------------------------------
VA Total................................................. 6,960,521 292,844.70 4,207.22
--------------------------------------------------
VA Average - 25%......................................... 3,155
-----------------
VA Average............................................... 4,207
-----------------
VA Average + 25%......................................... 5,259
----------------------------------------------------------------------------------------------------------------
Attachment D
ALTERNATIVES TO OXYCONTIN
There are several strong pain medications (opioids) which are just
as effective as treating severe pain as is OxyContin. There are no
studies in the medical literature which demonstrate OxyContin has clear
cut superiority over immediate release oxycodone, controlled release
morphine, transdermal fentanyl patches, or methadone when used in the
treatment of severe pain. Some of these have less abuse potential, and
some of these offer significant cost savings over OxyContin. In
reviewing oxycodone and OxyContin in the September 17, 2001 issue, The
Medical Letter concluded:
``OxyContin is a q12hour controlled-release formulation of
oxycodone that can be used effectively in the treatment of pain due to
cancer and, occasionally, other types of chronic pain. There is no
evidence that oxycodone offers any advantage over appropriate doses of
other opioids, and it appears to have the same potential for addiction
as morphine.''
Some of the studies are summarized briefly below--
Comparison: Immediate Release Oxycodone Versus OxyContin
Hale ME, et al. Efficacy and Safety of Controlled-Release Versus
Immediate-Release; Oxycodone: Randomized, Double-Blind Evaluation
in Patients with Chronic Back Pain; Clin J Pain 1999 Sep:15(3):
179-83 **
Conclusions: 47 patients randomized--``controlled-release
oxycodone given every 12 hours was comparable with immediate-
release oxycodone given four times daily in efficacy and safety
. . .
Kaplan R, et al.; Comparison of Controlled-Release and Immediate-
Release Oxycodone Tablets in Cancer Pain; J Clin Oncol 1998
Oct;16(10):320-7 **
Conclusions: 160 patients, double blind study--``CR and IR
oxycodone were equally effective in the management of cancer-
related pain''; --''. . . the adverse event profiles of CR and
IR oxycodone were similar. Overall, however, significantly
fewer adverse events were reported for CR oxycodone compared
with IR oxycodone . . .'' (somewhat less)
Stambaugh JE, et al.; Double-Blind, Randomized Comparison of the
Analgesic and Pharmacokinetic Profiles of Controlled- and
Immediate-Release Oral Oxycodone in Cancer Pain Patients; J Clin
Pharmacol 2001 May; 41(5):500-6 **
Conclusions: 32 patients--``CR provides equivalent analgesia as
IR oxycodone with the same patient acceptance profile''; ``. .
. similar incidences and numbers of reports of individual
adverse events considered related to the IR and CR drug''
Comparison: Controlled-Release Morphine Versus Controlled-Release
Oxycodone (OxyContin)
Heiskanen T and Kalso E.; Controlled-release oxycodone and morphine in
cancer related pain. Pain 1997 Oct; 73(1):37-45 **
Conclusions: 45 patients in a double-blind, randomized, cross-
over; ``the two opioids provided comparable analgesia''; ``the
total incidence of adverse experiences reported by the patients
was similar, but significantly more; vomiting occurred with
morphine, whereas constipation was more common with
oxycodone.''
Mucci-LoRusso P, et al.; Controlled-release oxycodone compared with
controlled-release morphine in the treatment of cancer pain: a
randomized, double-blind, parallel-group study. European Journal of
Pain (1998) 2:239-249 **
Conclusions: 100 patients--``controlled-release oxycodone was
as effective as controlled-release morphine in relieving
chronic cancer-related pain. . .''; ``the side-effect profiles
of CR oxycodone and CR morphine were similar overall in this
trial.''
Bruera E, et al.; Randomized, Double-blind, cross-over trial comparing
safety and efficacy of oral controlled-release oxycodone with
controlled-release morphine in patients with cancer pain. J. Clin
Oncol. 1998 Oct; 16(10):3222-9
Conclusions: 23 patients--``There were no significant
differences detected between the two treatments in . . .
adverse events, or clinical effectiveness . . .''; There are no
studies that we are aware of comparing controlled-release
oxycodone (OxyContin) with transdermal fentanyl or oral
methadone for treatment of severe chronic pain. There are a few
studies comparing transdermal fentanyl with oral morphine.
Transdermal Fentanyl Versus Oral Morphine
Payne RJ; Quality of life and cancer pain: satisfaction and side
effects with transdermal fentanyl versus oral morphine. Clin Oncol
1998 April 16(4):1588-93
Conclusions: 504 patients--``these data suggest that patients
are more satisfied with transdermal fentanyl compared with
sustained-release morphine''.
Ahmedzai S.J.; Transdermal fentanyl versus sustained-release oral
morphine in cancer pain: preference, efficacy, and quality of life.
J. Pain Symptom Management 1997 May: 13(5):254-61
Conclusions: both were equally effective in terms of pain
control; there was less constipation and sedation with
fentanyl.
**Purdue Pharma funded studies
attachment e--the medical letter--vol. 43 (issue 1113)--september 17,
2001
The Medical Letter has for decades been a gold standard of
thoughtful integrity for the evaluation of pharmaceutical drugs. For
the practicing physician, it has served as the most respected reference
for the evaluation of the proven safety and efficacy of medications, as
well as the appropriate role of a particular medication in the
pharmaceutical armamentarium.
The September 17, 2001 issue of the Medical Letter reviewed
oxycodone and OxyContin. Enclosed is the review.
Oxycodone and OxyContin
Recent reports of inappropriate use and diversion of OxyContin
tablets have prompted Purdue Pharma to include a ``Black Box Warning''
in the product labeling to call attention to the potential for abuse
and to reinforce the FDA-approved indication ``. . . for the management
of moderate to severe pain when a continuous, around-the-clock
analgesic is needed for an extended period of time . . .''
HISTORY--Oxycodone is a semisynthetic opioid analgesic structurally
related to morphine and codeine. It has been used in Europe by
injection and orally since 1917. Oral oxycodone 5-mg has been available
in the U.S. since the 1950's in combination with aspirin (Percodan) and
acetaminophen (Percocet, Tylox, Roxicet, and others). Subsequently
single-entity oxycodone became available in the U.S. as 5-mg immediate-
release tablets (Roxicodone, Percolone) and in liquid formulations.
Since 1996, Purdue Pharma has marketed controlled release oxycodone
(OxyContin) 10-, 20-, 40-, and 80-mg tablets intended for use every 12
hours. A 160-mg tablet was approved in March 2000 and withdrawn from
the market earlier this year. In street abuse, OxyContin tablets are
being crushed to make the entire dose immediately available, and then
snorted or dissolved in water and injected intravenously (IV). When
taken in this way by people with no tolerance to the drug, a single 80-
mg dose of OxyContin can be fatal.
ANALGESIC EFFICACY--In controlled clinical trials, the relative
analgesic potency of parenteral oxycodone to morphine has ranged from
0.7 to 1.5. Parenteral oxycodone is 10 to 12 times as potent as
codeine. Oral oxycodone is about 7 to 9.5 times as potent as oral
codeine. For treatment of cancer pain, OxyContin q12h has been equal in
analgesic effect to the same total daily dose of immediate-release
oxycodone q6h, 1.5 to 2 times as potent as controlled-release morphine
(MS Contin) q12h, and about 25% as potent as controlled-release
hydromorphone q12h (Hydromorph Contin--available in Canada) (P Mussi-
LoRusso et al., Eur J Pain 1998; 2:239; JE Stambaugh et. al., J Clin
Pharmacol 2001; 41:500; NA Hagen and N Babul, Cancer 1997; 79:1428). No
studies are available comparing oxycodone with other opioids used for
treatment of chronic cancer pain such as methadone or fentanyl (Drugs
of Choice from the Medical Letter 2001, page 138). In general, some
patients who do not respond to or cannot tolerate one opioid may
respond to or tolerate another.
OxyContin has also been used for treatment of moderate to severe
chronic non-malignant pain including back pain, osteoarthritis-related
pain, and during rehabilitation following total knee arthroplasty. No
studies are available comparing OxyContin with other opioids or any
other analgesics, such as nonsteroidal anti-inflammatory drugs, for
treatment of chronic non-malignant pain.
ADVERSE EFFECTS--The adverse effects of oxycodone are dose-related
and the same as those of other opioids. Common effects include
confusion, somnolence, dizziness, nausea, vomiting, constipation,
pruritus, dry mouth and sweating. Overdose may result in hypotension,
respiratory depression, cardiac arrest and death.
DRUG DEPENDENCE AND ABUSE--Oxycodone is a Schedule II controlled
substance with a dependence or addiction liability comparable to that
of morphine. Psychological dependence, physical dependence and
tolerance can develop with repeated administration. Withdrawal of the
drug in a physically dependent person results in an abstinence syndrome
like that of morphine and other strong opioids.
CONCLUSION--OxyContin is a q12h controlled-release formulation of
oxycodone that can be used effectively in the treatment of pain due to
cancer and, occasionally, other types of chronic pain. There is no
evidence that oxycodone offers any advantage over appropriate . . . to
have the same potential for addiction as morphine.
Senator Reed. Ms. Green?
Ms. Green. Thank you. First of all, I am very privileged to
be here.
I am representing Neighbors Against Drug Abuse. We are not
a professional group. We are four women in Down East, Maine--a
nurse-midwife, a nurse practitioner, a prevention health
specialist who works in the school system, and the secretary of
the medical staff at Calais Hospital. I am bringing their
voice, I am bringing the voice of my pregnant patients, their
unborn babies, and I am bringing you the voice of all the
addicts in Washington County. So I really am privileged to be
sitting so close to all these wonderful people and I have a lot
of messages for you.
OxyContin, a prescription pain medication introduced in
1995 by Purdue Pharma, has become a major drug of abuse in
Maine over the past 5 years. We realize this problem is not
unique to our State. Over the past 2 years Maine and, in
particular, Washington County's growing problem with OxyContin
has received international attention. The ready availability of
prescription narcotics, as well as the enormous profits to be
made by its illegal sale are too great to ignore.
Recreational use of the drug grew rapidly after its
introduction on the market and Maine became one of the first
States to report widespread abuse of OxyContin. Treatment for
narcotic abuse has increased by 500 percent since 1995. The
number of people admitted to treatment due to drugs such as
OxyContin rose from 232 in 1995 to 1,299 as of July 2001.
I am a certified nurse-midwife by profession but the
circumstances in our community have obliged me to become a drug
and alcohol counselor and also to spend many, many, many hours
with Neighbors Against Drug Abuse, which is our volunteer work.
I have had the opportunity through this to really get an inside
look at the lives of some of our addicts and their families and
I will give you some examples.
A young man describes how during the height of his
addiction, while snorting an Oxy, he had a massive nose bleed.
He tried to catch the blood with his hands and put it back in
his nose. He could see that he was losing some of his crushed
pills in his blood and was therefore losing his maximum high.
He was more concerned with getting his Oxy back into him than
catching his blood.
An elderly woman diagnosed with cancer came into my office
questioning whether the pharmacy had made a mistake in the
number of pills they had given her. Yesterday her bottle
contained 30 OxyContin pills but today she only counted 10. One
of her grandchildren, unknown to her, had been stealing her
medication for his own use and for sale to fund his addiction.
One of my clients during a counseling session even asked me
for money for drugs, she was so desperate.
Parents in my town call the police in order to have their
addicted children arrested. At least then they know that they
are temporarily safe and off the streets. I am a parent. I
would never want to make that choice.
A mother of four was given OxyContin for legitimate pain
relief but after some time was told by a friend that if she
snorted it it would be more effective. She became an addict,
lost her home, lost her children, and recently completed a two-
and-a-half-year prison sentence.
Local high school addicts now in recovery tell me that
eight out of 10 kids in their class are abusing some form of
substance and of this 80 percent, OxyContin was their substance
of choice.
A teenage client that knows I am here today has asked me to
give you the following message. ``Take OxyContin off the
market,'' and I am quoting her directly. ``But if you cannot or
you will not, then please make a rule where there is much more
supervision, regulation and control over it and change it so
that it is not so addictive and do not make it so easy for us
to get.''
Ten of my 40 mothers delivered just last year were opiate
abusers. They chose a prescription drug because they thought it
was safe. How could something legally available from doctors
possibly harm them or their babies? Needless to say, no newborn
baby should have to endure narcotic withdrawal as its
introduction into the world.
This drug problem is contributing to the break-up of our
families. An estimated 50 percent of child protective and
custody cases in the court systems in our State involve family
abuse of prescription drugs.
Opiates used to be the end of the line for drug addicts.
Now it appears that prescription opiates may be one of the
first drugs abused. In correlation with this finding, the
incidence of hepatitis C and HIV have escalated into major
public health risks.
I could keep you here for hours and hours and hours telling
you story after story after story and the desperation in our
town. Believe me when I tell you that since the legal
introduction and illegal diversion of OxyContin, a dark cloud
hangs over Down East, Maine and I do not see it clearing for a
long time.
Even if OxyContin, Dilaudid, heroin and others by some form
of miracle or magic disappeared, we would still be left with a
community that is scarred forever. The consequences of these
addictions are life-long.
Unlike other affected communities, we have an addicted
population which is isolated geographically with no access to
treatment facilities. We have nothing. We have no
transportation. We have minimal counseling and we need more
support and education.
In order to address the dramatic problem of the abuse of
OxyContin and other prescription drugs, we are making the
following recommendations. Increase access and funding for
treatment. We are in desperate need of local detox and rehab.
Increase funding for public education and prevention. Increase
funding for law enforcement to address diversion of legal drugs
to illegal use, targeting areas with the greatest need and
fewest resources.
Develop State-wide Federal and international electronic
prescription monitoring programs so that there is dialogue
between the physician, the pharmacy, and a central databank. We
are encouraging the FDA--and thank you for being here--we
really would like Buprenorphine. We have been waiting for
almost 2 years.
And finally, Purdue Pharma, please stop sending OxyContin
in the mail to clients on their patient assistant program.
These shipments are easily intercepted. It would be
irresponsible for you to continue.
We also know that you are very, very busy helping everyone
else in our country. I am only asking you to please do not
forget us. Thank you.
Senator Reed. Thank you, Ms. Green.
[The prepared statement of Ms. Green follows:]
Prepared Statement of Nancy Green, C.N.M.
``Never doubt that a small group of thoughtful, committed citizens
can change the world. Indeed, it is the only thing that ever has.''--
Margaret Mead.
Mr. Chairman, and Members of the Committee, I am Nancy Green, a
certified nurse midwife in Calais, Maine. I have a Bachelor of Science
in Nursing from Duquesne University and a Master of Science in Nursing
from Case Western Reserve University, and I am certified as a nurse
midwife from Frontier School of Midwifery and Family Nursing. I am
board certified through the American College of Nurse Midwives. I am
also one of the founders and now president of Neighbors Against Drug
Abuse (N.A.D.A.), a ``grass roots'' group of citizens who have come
together because of our concern with our current and still evolving
substance abuse epidemic and crisis in Washington County, Maine.
The Problem
Washington County, population 35,352, is entirely rural, with a
natural resource and service based economy. Its 47 towns, ranging in
population from 10 to 4000, are widely dispersed in a heavily wooded
region encompassing 2569 square miles, which corresponds to 14 persons
per square mile in an area roughly twice the size of Rhode Island.
Severe winters, poor road conditions and lack of public transportation
contribute to the geographic isolation of the county.
The extreme poverty, poor economic environment, and low education
achievement in the rural and isolated Washington County contribute to a
social climate characterized by high stress, broken families, and poor
preventative health care. These conditions contribute as risk factors
to high rates of substance abuse starting with school age children and
eventually leading to the high rates of prescription opiate abuse,
which are poorly addressed by the limited resources for treatment and
preventative interventions.
The geographic isolation, combined with a lack of transportation,
contribute to a substantial barrier for substance abuse patients to
access medical and mental health care or social services. In addition
to difficulties for patients to travel, these factors pose a major
challenge for health programs to deliver services and coordinate
patient care in a timely and cost effective manner. Moreover, the
stigma of drug abuse and the lack of anonymity in small towns are well
known barriers for clients seeking services in a rural area.
Emergence of the Current Epidemic
In 1999, the Office of the U.S. Attorney for the District of Maine
noticed that law enforcement seizures and arrests for illegal
possession of OxyContin and other abused synthetic narcotic
prescription drugs had jumped nine fold. Arrests for illegal possession
have quadrupled in four years. In Washington County, adult arrests for
possession of synthetic narcotics were 2.5 times that for the state.
The rate of possession of opiates or cocaine was twice the state
average, and reports of arrests for breaking and entering were elevated
67 percent over the state (source: Maine Department of Public Safety).
In October 1999, U.S. Attorney Jay McCloskey traveled to Washington
County to meet with concerned citizens. ``The prescription pain
medication abuse is the most serious criminal problem facing Maine and
may be the most pressing social problem,'' he said at the meeting. I
attended the meeting because a phone call from Carrie MacDonald, a
friend and patient of mine, who works for the Calais school system as
the prevention coordinator under the Safe Schools and Healthy Students
Initiative. She felt that this would be an important meeting for me, as
a health care provider, in particular caring for women and newborns, to
attend. And, she was right.
I still remember how I felt that October day last year. What a
coincidence that this same day, I was approached by one of my patients,
a 19 year old expecting her second baby, who was in her second
trimester of pregnancy, asking for help. ``Please get help for me,''
she said, ``I was arrested for selling opiates outside the Calais
Junior High School. I have been addicted to opiates for four-five
years. I need to get `clean'.''
I made several phone calls to the emergency room at the Calais
hospital and to Calais mental health counselors. They told me that
there was NO help for her in this part of the state. I made phone calls
to Mercy Hospital in Portland, Maine, a four hour drive away. They
accepted her as a patient, but only because of her advanced stage of
pregnancy. Otherwise, waiting lists for patients to get into ``detox''
were and still are four to six months long.
One week later, I received a phone call from this patient from
Portland, in tears, asking me to take her back as a patient. ``I miss
home. I know you and trust you. I want you to deliver my baby.'' I
explained to her that she could NOT come home, since there was nothing
for her here in the way of substance abuse treatment, support or
counseling. Also, she could not come back to the same environment she
left from, same ``circle of friends,'' ``same life.'' I told her,
``it's not safe for you to come home.'' What a coincidence that this
took place about one hour before our meeting with U.S. Attorney
McCloskey. I was able to share my very recent encounter with him and
the group in attendance.
By January 2001, I was caring for six pregnant women, at all stages
of pregnancy, with addiction to ``legal'' prescription medications. By
now, I was becoming an ``expert in addiction.'' One of my patients who
had transferred her care from another provider in January, delivered
her baby four weeks prematurely. I could not understand why she was
having such an unusual labor pattern, and why so early. She finally
admitted to me in the birthing room, while laboring, that she was an
opiate addict. Things became very clear to me--she had ``snorted'' four
days before, but not since then. What I was seeing was actual
withdrawal, not just hers but that of her soon to be born baby. She
told me she ``snorted oxys.'' I told her she was now going to have an
addicted baby, and she said to me:
``My friends told me it was safer for me to snort OxyContin
because it was a legal prescription, written by doctors, and
that nothing would happen to the baby.''
She ended up having the baby who went through withdrawal in the
nursery (e.g., high pitched crying, difficult to console, exaggerated
movements, tremors). Our pediatricians provided excellent care to this
baby. The baby's grandmother adopted the baby in order to avoid the
Department of Human Services ``placing the baby with a stranger.'' My
patient, I'm glad to say, has done extremely well with detox and rehab,
through my support and the support of the few substance abuse
counselors we have in the community.
``The drug problem is contributing to the break-up of families,''
according to Circuit Court Judge John Romei, who estimates that half of
the child custody cases he handles involve family abuse of prescription
drugs. ``If there is a bigger problem in regard to the criminal justice
system in this county, I don't know what it is . . .. I've taken
children away from numerous young moms because of prescriptive narcotic
abuse.''
An attorney in the area stated that she has served as court
appointed attorney for approximately 40 young women in child protective
cases involving prescription drugs. ``I had my first child protective
case involving opiates three or four years ago. Now it's just
routine,'' she said.
Two more of my patients delivered this past week. With again,
support from me, the one substance abuse counselor in town, education
and determination, these women have been drug free for the past four to
five months. Their babies were born weighing approximately five pounds
at term. Luckily, and so far, this was the only consequence of their
mothers' addiction earlier in their pregnancies. Several of my other
addicted patients have suffered pregnancy losses, again at differing
stages of their pregnancies.
A very dangerous consequence of substance abuse, and a serious
public health issue, is the recent rise of Hepatitis C. According to
Maine Center for Disease Control reports, a 47 percent elevation over
state levels of Hepatitis C was identified within the county in 2000.
This correlates with the epicenter of the recent epidemic of synthetic
narcotics. Only 10 percent of opiate addicts have been tested for
Hepatitis C and, of those tested at least 30 to 40 percent have tested
positive. That percentage may actually be higher since there is at
least a six month time lag from exposure to Hepatitis C and any
resulting infection to testing positive. If we assume a similar rate of
infection among untested addicts. It means that 90 percent of Hepatitis
C cases among the addict population have yet to be identified.
When speaking to our addicted patients who are still in recovery,
they explain to us how they ``crush the tablets'' and then snort them
with straws or use the bottom parts of pens, and/or they dissolve the
tablets with water and inject them. Crushing or dissolving the tablet
disarms the timed-release action of the medication causing a quick,
powerful high similar to that of heroin. Hepatitis C is transmitted
through blood to blood contact. When snorting, the mucous membranes in
the nose become weakened and bleed. Addicts share their ``snorting
utensils'' and, therefore, share Hepatitis C. HIV takes much longer to
``show-up'' in a person. Hepatitis C sbows up within a short period of
time.
Listening to people affected with addiction is the most heart
wrenching experience. One young man described how he moved along the
progression of addiction from marijuana and alcohol to Percocets and
Dilaudid (i.e. other forms of opiates). But when introduced to
OxyContin, ``bam what an experience!'' ``Nothing else compares to it.''
``An immediate sense of euphoria and that can't be described.'' The
feeling with OxyContin is so magnificent that all other drugs of abuse
pale by comparison. ``I didn't want anything else.'' ``I knew I was
`hooked' within two days of trying `oxys'.'' ``I needed and wanted
more.'' ``I couldn't wait to get up in the morning to snort another
one.'' ``It is cheaper for me to buy oxys in Canada because it is much
cheaper than in Maine. I can buy a 40 (40 mg. Tablet) for $20.00 U.S.
instead of $40.00 here at home.''
Parents and grandparents describe how their families have been
afflicted by this crisis. One family had their bible, which had been in
the family for over 100 years, stolen by their child in order to get
money to sustain her habit. Her own family called the police and had
her arrested ``because we just couldn't deal anymore with this
problem.''
Some quotes from the extensive press coverage of the OxyContin
epidemic in Washington County highlight the large impact. For example,
from a March 23, 2001, Boston Globe article, ``Painkiller Tears Through
Maine'':
``OxyContin, a remarkably effective painkiller, is shredding
the social fabric of parts of Maine, creating a Wild West-like
anarchy in many communities. Pharmacies are being held up, the
gunmen demanding only pills. Neighbors are robbing, even
assaulting, one another. One couple tried to smuggle the drug
from Canada, where it is cheaper, in the underpants of their
handicapped child.''
Why rural Maine has been subject to this rapid growth in
prescription narcotic abuse appears attributable to several factors,
including the following:
The ready availability of the drug from the diversion of
prescriptions or fraudulent prescriptions allowed abuse to develop
among a larger population of users than typically have ready access to
heroin.
A Maine legislative rule in 1999 contributed to the
problem by requesting doctors to treat pain more aggressively.
The great profits to be made by its illegal sale are an
additional reason why OxyContin abuse has grown so quickly. A 40
milligram pill costs approximately four dollars by prescription, yet it
may sell for $35 to $40 on the street. Thus, a 100 tablet bottle
purchased for $400 or subsidized through Medicaid, can sell for as much
as $4,000 on the black market. In areas already beset by high
unemployment and poverty rates, such high profits can tempt even
``average'' citizens to sell some or all of their family member's
legitimate prescription. From this level of diversion, progressively
more criminal steps predictably follow for addicts who need to sustain
their habit and/or dealers seeking profits. These include ``doctor
shopping'' with fake back injuries, forging or altering prescriptions,
theft from incapacitated relatives with chronic disease, robberies of
homes and pharmacies and, ultimately, armed robberies with assaults on
those with legitimate prescriptions.
Neighbors Against Drug Abuse (N.A.D.A.)
N.A.D.A. was formed after hearing reports from the Maine U.S.
Attorney and the Maine Office of Substance Abuse, and professional
contact with substance abuse in our practices. It has five members: a
prevention specialist with the Calais school system, a nurse
practitioner, parents of an addicted son, and a certified nurse
midwife.
N.A.D.A. is a group of citizens who have come together because of
our concern over the very high and increasing problem of substance
abuse in Washington County, in particular the abuse of opiates. We act
as a fact finding and steering committee. Our group is further
subdivided, focusing on prevention/education, treatment, law
enforcement and funding (i.e., local, state, federal, private). We
organized in December 2000. We work out of our kitchens, cars, anywhere
we find space, and we have functioned without a budget! However, we
have been able to bring awareness to the community, having launched an
enormous public campaign through public meetings and media interviews.
We applied for a $100,000.00 per year for five years grant from the
federal Office of Juvenile Justice and Delinquency Prevention (OJJDP)
to fund prevention efforts in northeastern Washington County. We have
had no response. As a result of a workshop we organized in March 2001,
the Washington County Planning Commission on Opiate Addiction Treatment
was formed.
The Plan
I. The Planning Commission has determined there are a number of
treatment services that are considered critical to effectively treat
opiate addicts in the county. These are:
a) Intensive outpatient program
b) Replacement therapies
c) Outpatient counseling
d) Medical care
e) Nutrition counseling
f) Support services (intensive supports for recovering person
including case management, help to reconstitute the family,
employment, housing, financial assistance, recreation,
transportation, drug testing and others)
g) Family counseling
h) Education
Unlike other affected communities, we have an addicted population
that is isolated geographically, with no access to treatment
facilities, transportation, counseling, support or education.
II. A federal Substance Abuse and Mental Health Administration
Center for Substance Abuse Treatment (SAMHSA/CSAT) Grant for treatment
services of $500,000 per year for three years was submitted on
September 7, 2001. If awarded, this grant would not become available
until the summer of 2002.
III. A smaller proposal for support to continue the work of the
Commission over the next year, on detailed implementation and planning
for the treatment services, has been submitted.
IV. $100,000.00 per year for five years to fund prevention efforts
(Office of Juvenile Justice and Delinquency Prevention) for N.A.D.A.
V. Continued support from the Main Office of Substance Abuse (OSA).
We hope to obtain direct funding next year from OSA for partial
support.
VI. Help from the county delegation to build support in the state
legislature for replacing this $500,000.00 per year federal grant
within three years, assuming we get the grant.
VII. The Washington County Sheriff's Office has reported that there
are now over 1000 known opiate addicts in the county. The plan is to be
able to offer intensive outpatient services to 30 percent of this
population within the second year of operation.
Recommendations
1. Make awards of grants now. Money is needed now, not in July
2002. This crisis is present and worsening. Addiction experts have
calculated that for every one dollar spent on rehabilitation of addicts
approximately seven dollars are saved in the criminal justice system.
2. Nine months to ``read and decide'' over a grant application is
too long. Particularly since it takes time to recruit professionals and
set up licensed treatment facilities.
3. $500,000 per year is a beginning but barely scratches the
surface of what we need in order to provide comprehensive care. One
cannot deal with a problem of this magnitude with $500,000 per year.
4. We recommended that awards of S500,000 per year be given to help
addicted adults and an additional $500,000 per year to help addicted
adolescents initially over a period of three years. Ongoing assistance
will definitely be needed.
5. We are asking that Purdue-Pharma establish foundations and make
donations to help affected communities deal with opiate addiction. We
feel that this is the moral thing to do especially because the fabric
of our community is being destroyed mainly by addiction to OxyContin, a
Purdue-Pharma product that the company heavily promoted.
Concluding Thoughts
While we don't know where the story of opiate addiction begins for
the addicts of Washington County, we can predict that their current
prospects, and the prospects of the towns in which they live, are bleak
unless access to a comprehensive treatment program becomes available
immediately. The energy behind this planning effort comes from the
stark realization that the future of this isolated rural county is
hanging in the balance.
Senator Reed. Lieutenant Bess?
Lt. Bess. Mr. Chairman and Members of the Committee, I
would like to mention that I have with me today senior special
agency Al Cameron from our Fairfax field office and senior
special agent Tim Price from our Wytheville field office.
Although diverse areas, both have seen OxyContin problems.
The Virginia State Police Pharmaceutical Diversion
Investigative Unit, now the Drug Diversion Unit or DDU, was
implemented in the fall of 1987. The mission of the unit since
its inception has been the statewide investigation of criminal
diversion of illegal drugs to the illegal market, the
establishment of a database to assist in the identification of
the scope of the diversion activities in the Commonwealth, and
the education of health care professionals, law enforcement and
general public concerning the problems of diverted drugs.
The demand for OxyContin as a street drug is quite high in
certain areas of Virginia. In southwestern portions of the
State, local law enforcement agencies indicate that the demand
for OxyContin is exceeding the demand for illicit drugs such as
heroin. Also, in some areas of Northern Virginia such as
Fairfax and Prince William Counties, the demand for OxyContin
is increasing. The number of diversion complaints reported to
DDU involving OxyContin has increased from 13 in 1997 to over
300 in 2000, the last year we have the statistics for.
OxyContin is being diverted primarily through doctor-
shopping and to some extent illegal prescribing by a relatively
few physicians and when individuals obtain more than is
medically necessary, the drug is often sold on the street. DDU
is investigating cases in which patients travel from West
Virginia and Kentucky into Northern Virginia and Tidewater to
obtain OxyContin. We recently had a case in which a lady drove
from North Carolina into Southwest Virginia to sell OxyContin.
The Department of State Police have several recommendations
to help reduce the diversion and abuse of these, as well as
other prescription drugs. First, we strongly support the
creation of a prescription monitoring program in our State or
nationwide. This system would essentially capture data on the
type and amount of substances dispensed, the prescribing
physician, the dispensing pharmacist and the patient receiving
the medication. The data is submitted electronically by the
dispensing pharmacy on a periodic basis. The program allows for
medical privacy and gives no one access to pharmacy records
that does not currently have access to those records.
The second recommendation to be made to the Virginia
General Assembly is to increase the penalty for the
distribution of Schedule III and IV controlled substances from
a misdemeanor to a felony. I believe Virginia and Maine are a
few of the last States that have misdemeanor distribution of
those schedules.
A third recommendation is to require a customer to produce
photographic identification when obtaining a Schedule II drug.
The Department of State Police also feel that any
legislation enacted should not hinder access to medication by
persons who have a true, legitimate medical need for the drug.
Those people in pain should have pain relief.
That concludes my statement.
Senator Reed. Thank you very much, Lieutenant.
[The prepared statement of Lt. Bess follows:]
Prepared Statement of Lieutenant William R. Bess
Mr. Chairman, and Members of the Committee: I am pleased to be here
today to discuss with you what we feel is a very important public
safety issue, the abuse of OxyContin.
The Virginia State Police Pharmaceutical Diversion Investigative
Unit, now the Drug Diversion Unit (DDU), was implemented in the fall of
1987 with the receipt of federal and state grants. The mission of the
unit, since its inception, has been the statewide investigation of
criminal diversion of legal drugs to the illegal market; the
establishment of a data base to assist in the identification of the
scope of the diversion activities in the Commonwealth, and the
education of health care professionals, law enforcement and the general
public concerning the problem of diverted drugs. Currently, the Unit is
funded solely by the Department of State Police.
The Virginia Department of Health Professions deal with excessive
prescribing, a regulatory matter. The Virginia State Police deal with
illegal prescribing, a criminal matter. In investigating the diversion
of prescription drugs since it's creation, DDU has seen the drug of
choice and the popularity of different drugs change. Until recently it
was felt that RITALIN was in line to become one of the most popularly
diverted drugs. Ritalin has now been surpassed by OXYCONTIN as one of
the leading diverted drugs. Hydrocodone has and continues to be a
leader in diverted drugs as well. Hydrocodone is one of the most
popular drugs diverted for personal use by health care professionals.
Many other drugs of all Schedules II-VI are often diverted.
The diversion and abuse of Ritalin (Methylphenidate) and OxyContin
(Oxycodone) continues to be a problem in Virginia. The demand for
OxyContin far exceeds the demand for Ritalin. Across the Commonwealth,
State Police Drug Diversion Agents report that investigations involving
the diversion of Ritalin are relatively small in comparison with the
diversion of Hydrocodone and Oxycodone products.
The Drug Enforcement Administration reports that the number of
prescriptions for Ritalin has increased 600% over the last five years,
nationwide. The State Police Drug Diversion Unit received 3 complaints
of Ritalin diversion in 1998, 9 in 1999 and 7 in 2000. To date this
year, the Unit has received 8 complaints of Ritalin diversion.
The demand for OxyContin as a street drug is quite high in certain
areas of Virginia. In southwestern portions of the state, local law
enforcement agencies indicate that the demand for OxyContin is
exceeding the demand for illicit drugs such as heroin. Also in some
areas of northern Virginia, such as Fairfax and Prince William
Counties, the demand for OxyContin is increasing. The number of
diversion complaints involving OxyContin has increased from 13 in 1997
to over 300 in 2000. The increase can in part be attributed to the fact
that OxyContin is a new drug, marketed since 1996. The demand on the
street has steadily increased since the drug became available.
Improperly used OxyContin has the same effect as heroin.
OxyContin is being diverted primarily through ``Doctor Shopping''
and to some extent illegal prescribing by a relatively few physicians.
When individuals obtain more than is medically necessary, the drug is
often sold on the street. In addition, it is reported that some
OxyContin, and other drugs, are being imported from Mexico and Canada
by individuals who travel to those countries to obtain drugs, also we
hear antidotal reports of individuals using the internet to obtain
controlled substances. There are some instances in which prescriptions
are forged or altered in an attempt to obtain the drug. OxyContin is
abused by crushing the tablet and then snorting the powder or mixing it
with water and injecting the solution. Oxycodone is the single active
ingredient in OxyContin and is similar to Morphine in dependence
liability.
In some areas of the Commonwealth, ``patients'' are travelling to
North Carolina in an attempt to obtain prescriptions for OxyContin.
North Carolina State Bureau of Investigation Agents relate that North
Carolina is the largest source of OxyContin in the country. A portion
of that will appear on the street in Virginia. OxyContin sells for
about one dollar per milligram on the streets in Virginia (about 10
times its retail price). DDU is investigating cases in which
``patients'' travel from West Virginia and Kentucky to Northern
Virginia and Tidewater for OxyContin.
The use of Ritalin and OxyContin for non-medical purposes is a
problem among school-aged children and college students in the
Commonwealth. However, the number of instances these drugs are abused
by this age group is relatively small in comparison with those that are
not students. Local law enforcement agencies have made arrests of
students involved in the unlawful possession and/or distribution of
these drugs. Other drugs, such as Ecstasy, Ketamine and GHB appear to
be the choice for younger people.
Campus police agencies at Virginia Commonwealth University,
Virginia Tech and Radford University report no arrests involving
Ritalin or OxyContin on campus. Arrest statistics compiled by the
Virginia State Police reveal that the largest age group of persons
arrested for all prescription drug violations is between 31 and 40
years old.
In an effort to assist other agencies in diversion investigation,
the Department of State Police conducted its first Drug Diversion
School, September 17-21, 2001. This training was provided free of
charge to law enforcement officers from across Virginia and across the
nation. Over 70 State, Federal, and local police officers involved in
drug diversion investigations signed up to attend this training. In
addition to basic drug investigations, the school covered such topics
as the legitimate use of narcotic analgesics by the medical community,
club drugs, steroids, insurance fraud and other matters.
The Department of State Police has several recommendations to help
reduce the diversion and abuse of these, as well as other, prescription
drugs. First, we strongly support the creation of a Virginia
Prescription Monitoring Program. This program, already in place in 17
states, allows a state agency to monitor the dispensing of controlled
substances. It essentially captures data on the type and amount of
substance dispensed, the prescribing physician, the dispensing
pharmacist and the patient receiving the medication. The data is
submitted electronically by the dispensing pharmacy on a periodic basis
to the agency managing the program. The program allows for medical
privacy and gives no one access to pharmacy records that does not
currently have access to those records. It simply makes the access
readily available to doctors, pharmacists and selected law enforcement
officers.
Currently, if a physician has reason to believe that a patient may
be ``doctor shopping'' in an effort to obtain controlled substance, the
physician has no mechanism to determine that, short of calling all
other physicians in the state. Under the proposed Virginia monitoring
program, the physician can fax in a request to the program manager and
request that data. A pharmacists who suspects a patient is abusing
drugs could also request data to determine if the medications being
dispensed could react badly to other drugs being received by a patient,
The ability of Virginia health care professionals to receive this
critical information is not the norm for existing prescription
monitoring programs. In addition, State Police Special Agents who are
designated by the Superintendent to conduct drug diversion
investigations (currently only 14 agents and two supervisors) could
access the data on a specific criminal investigation. Those agents
currently have the authority to obtain pharmacy records, but they must
travel to each pharmacy and interrupt the pharmacist to get the
information.
A prescription-monitoring program allows health care professionals
with specific patient concerns and law enforcement officers
investigating a specific diversion case access to data with the least
intrusion on pharmacists, physicians and patients. This program will
help prevent drug abuse by those persons seeking narcotics for non-
medical purposes and help ensure that those patients who do need
medication have access to it.
A second recommendation, to be made to the Virginia General
Assembly is to increase the penalty for the distribution of a Schedule
III and IV controlled substance from a misdemeanor to a felony. The
illegal distribution of drugs such as hydrocodone products (Vicodin,
Lortab, Anexsia and others), Ketamine, Valium, Xanax, Talwin and others
are far more common than other drugs. Current law makes it a felony to
obtain these drugs by fraud, but only misdemeanor if they are sold on
the streets. Savvy drug users know that increased amounts of Schedule
III drugs will give the same effect as smaller amounts of Schedule II
drugs. The reduced scrutiny and penalties for violations involving
Schedule III drugs often result in drug seekers obtaining those drugs
instead of Schedule II drugs.
A third recommendation is to require a customer to produce photo
identification when obtaining any Schedule II drug. The name on the
identification would have to match the name used on the ``sign out
log'' maintained by the pharmacy. This procedure would allow accurate
identification and create a record of who is picking up a Schedule II
drug and eliminate most situations involving identity fraud. By state
law, pharmacists may currently ask for identification, but are not
required to do so.
Agents assigned to this unit have a higher caseload than in any
other area of the Bureau of Criminal Investigation. Because there is a
need to increase resources available to the State Police Drug Diversion
Unit additional agents are being requested across the state. In
addition to conducting investigations, these agents are heavily
involved in training police officers and health care professionals in
the investigation and prevention of this type of crime.
The Department of State Police also feel that any legislation
enacted should not hinder access to medication by persons who have a
true legitimate medical need for the drug. In addition, the Department
feels that any legislation should not be ``product specific'' but
rather relate to a drug Schedule or class of drug. Simply changing the
name of the drug could easily circumvent any legislation directed
toward a brand name.
Senator Reed. Dr. Goldenheim?
Dr. Goldenheim. Thank you very much. Mr. Chairman, on
behalf of Purdue Pharma, the distributor of OxyContin tablets,
thank you for taking the time to hold this hearing, which bears
on a significant question of health policy--how to address the
problems of abuse and diversion which accompany the sale of a
controlled drug like OxyContin without, as we have heard,
restricting its availability to meet the needs of patients for
the effective management of pain. I would like to take a few
moments this afternoon to describe some of our efforts and idea
for addressing the abuse and diversion of prescription drugs.
Once Purdue became aware of the problems of abuse and
diversion of OxyContin, addressing this issue became a
corporate priority. Purdue's number one research priority is to
develop medicines that would reduce drug abuse while, at the
same time, function as intended for patients in pain.
Contrary to what some seem to think and as noted by Dr.
Jenkins, this is a formidable undertaking as there is no
existing proven technology to achieve this goal. Purdue will
have spent more than $100 million by the end of this year to
research and develop new forms of abuse-resistant pain
relievers.
Perhaps the single most important tool to prevent abuse is
education. According to a survey released in December by the
National Association of State Control Substance Authorities,
its members believe that diversion education and pain
management education for prescribers are more effective than
any other means of combating drug abuse.
Purdue's objective in communicating with doctors through
our trained sales representatives, literature and educational
programs, is to inform them about the proper use of OxyContin.
Increasingly this role has focussed on avoiding abuse and
diversion. Responsible physicians will only prescribe OxyContin
if it is the right product for their patients with pain.
Let me please call your attention to examples of some of
the materials our field force uses when it calls on physicians.
Dr. Jenkins referred to the ``Dear Health Care Professional''
letter that Purdue distributed to help educate health care
professionals about the risk. We have also distributed hundreds
of thousands of these documents from the American Pain Society
and the American Academy of Pain Medicine since 1997 entitled
``The use of opiods for the treatment of chronic pain.''
Additionally, we have furnished for the record the
following material. Purdue has worked from the FDA to develop
the special patient information leaflet, and Dr. Jenkins
referred to it, intended to be given by the physician or
pharmacist to every patient receiving a prescription for
OxyContin. Purdue has also developed and distributed these
brochures on prevention of abuse and diversion to virtually all
the physicians who prescribe and pharmacists who dispense opiod
analgesics in the United States. Our representatives have
distributed these opiod therapy documentation kits, again since
about 1997, and over 250,000 copies of the model guidelines for
the use of controlled substances for the treatment of pain.
These materials supplement Purdue's extensive training and
educational efforts that are described in my written testimony,
including our sponsorship of significant programs for doctors
that are geared specifically toward preventing abuse and
diversion.
Educating teenagers about the risks and dangers of
prescription drug abuse is critical and we have initiated an
important program that we are calling Painfully Obvious. Please
take a look at this packet of information about the program
that we have furnished for the record. All of this material is
designed to help capture the attention of teenagers and convey
the message that abusing drugs is not cool. This program will
be rolled out by midyear in Florida, Pennsylvania, Ohio, West
Virginia, Kentucky, South Carolina, Maine, Massachusetts and
Virginia.
Other Purdue initiatives described in my written statement
including supplying tamper-resistant prescription pads to
physicians, supplying placebo OxyContin tablets to law
enforcement for reverse buy-and-bust sting operations, and
developing a better system for gathering more reliable and
timely information about abuse and diversion. To assist law
enforcement in determining the country of origin in drug
seizures Purdue changed the tablet markings on OxyContin
exported to Mexico and Canada.
Purdue feels strongly that prescription monitoring
programs, PMPs, would help. Purdue supports the adoption by all
States of prescription monitoring programs meeting appropriate
standards and we have submitted for the record our policy on
PMPs. We encourage this committee to develop legislation to
provide States with incentives to provide such prescription
monitoring programs. They can reduce doctor-shopping and
diversion from good medical practices by giving physicians a
way to identify patients who are receiving controlled
substances from other doctors.
According to official positions taken by the American
Medical Association, the Food and Drug Administration, the Drug
Enforcement Administration, the Department of Veterans Affairs
and even the Congress of the United States, which has declared
this the decade of pain control and research, the management of
pain is a critical priority of health care in this country.
OxyContin has proven itself an effective weapon in the fight
against pain, returning many patients to their lives, to their
families, to their work and to their enjoyment of life.
We cannot turn back to an era when physicians did not treat
significant chronic pain. The answers to the problems of abuse
and diversion require the cooperation of many elements in our
community in providing increased education, information, and
enforcement, not restrictions that will deny patients effective
treatment of their pain. Purdue is taking a leadership role in
these efforts. Thank you very much.
Senator Reed. Thank you very much, Dr. Goldenheim, and
thank you all very much for your testimony this afternoon.
[The prepared statement of Dr. Goldenheim follows:]
Prepared Statement of Paul D. Goldenheim, M.D.
Mr. Chairman: On behalf of Purdue Pharma L.P., the distributor of
OxyContin tablets, thank you for taking the time to hold this hearing
which bears on a significant question of health policy: how to address
the problems of abuse and diversion which accompany the sale of a
controlled drug like OxyContin without restricting its
availability to meet the needs of doctors and patients for the
effective management of pain. This question is neither new nor unique
to OxyContin. It has existed as long as opioid analgesics
have been available. It is a critical question, and we are confident
that Purdue has devoted more resources and efforts than has any
pharmaceutical company in seeking the answers. Purdue has taken a
leadership role and has provided, and continues to provide, extensive
assistance to the medical and law enforcement communities in working to
prevent the abuse of OxyContin.
1. WHAT IS THE NATURE OF THE PROBLEM?
OxyContin is an opioid analgesic used to treat pain. Each
tablet of OxyContin delivers controlled-release oxycodone to
the patient over a period of twelve hours. Like morphine,
OxyContin is a Schedule II drug with recognized abuse
potential. Purdue and the Food and Drug Administration assessed and
acknowledged the potential for abuse at the time of its initial
approval. From inception, the package insert and promotional material
for OxyContin has cautioned:
``TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN,
CHEWED OR CRUSHED. TAKING BROKEN, CHEWED OR CRUSHED
OxyContin TABLETS COULD LEAD TO THE RAPID RELEASE AND
ABSORPTION OF A POTENTIALLY TOXIC DOSE OF OXYCODONE.''
Additionally, the following language has always appeared on the
package insert:
``Patients should be advised that OxyContin
is a potential drug of abuse. They should protect it from
theft, and it should never be given to anyone other than the
individual for whom it was prescribed.''
``Oxycodone may be expected to have additive effects
when used in conjunction with alcohol, other opioids or illicit
drugs which cause central nervous system depression.''
``As with all such drugs, care should be taken to
prevent diversion or abuse by proper handling.''
Since early in the year 2000, there have been a significant number
of reports of OxyContin tablets being diverted and abused by
drug abusers, and we at Purdue deeply regret the tragic consequences
that have resulted from the misuse of this medicine. The patterns of
abuse involve crushing the tablets to obtain immediately the full dose
of oxycodone and then ingesting, snorting or injecting the drug. In a
number of cases, there have been deaths associated with overdose. We
believe that virtually all of these reports involve people who are
abusing the medication, not patients with legitimate medical needs
under the treatment of a healthcare professional. Further, the vast
majority of those deaths involve the abuse of multiple medications
including other opioids (illicit and legal) and frequently alcohol and
sedatives such as benzodiazepines--not oxycodone alone.
2. WHAT IS PURDUE DOING TO REDUCE THE ABUSE AND DIVERSION OF
OXYCONTIN?
Purdue was deeply distressed when it became aware of the
occurrences of abuse and diversion of OxyContin and
immediately formed a response team of top Company executives and
physicians who immersed themselves in the problems of abuse and
diversion and made its solution a corporate priority. To help
understand and address the problems, Purdue's Chief Operating Officer,
General Counsel, and senior medical officers have attended numerous
meetings with State Attorneys General and U.S. Attorneys, and many
additional meetings have been held with FDA, Drug Enforcement
Administration, medical opinion leaders and others. Virtually all of
these meetings were initiated by Purdue, including the very first such
meeting in September of 2000 with then United States Attorney for
Maine, Jay McCloskey. Mr. McCloskey, who is now serving as a consultant
to Purdue, is here today and available to answer questions you may have
about the abuse of OxyContin and other drugs in Maine. We
believe that his 23 years of experience as a Federal prosecutor,
dealing with the very issues which are the subject of this hearing, can
provide invaluable insight to this Committee.
Additionally, Purdue has established an internal Health Policy
Group devoted to guiding the company in its policies and programs to
address the issues of abuse and diversion, including the education of
law enforcement. The Health Policy Group includes three full time
physicians who are well known experts in the fields of addiction and
pain management and a former career law enforcement officer who managed
the largest pharmaceutical diversion unit in the nation.
Purdue's efforts to address the problem include the following
specific actions:
A long-term solution to the problem of prescription drug
abuse includes the development of medicines that are inherently
resistant to such abuse. This was and is a formidable undertaking as,
contrary to comments that have been made by some who have not studied
the matter, there was no existing proven technology to achieve this
goal. By the end of 2002, Purdue will have spent over $100 million to
research and develop new forms of strong pain relievers that would be
resistant to abuse while at the same time provide safe and effective
pain relief to legitimate patients. In December 2001, we announced the
beginning of clinical studies of a new pharmaceutical product combining
the opioid analgesic oxycodone in a controlled-release formulation with
an opioid antagonist, naloxone. We expect that this product will be
resistant to abuse by injection and perhaps, also by intranasal
snorting. We are working with the FDA to accelerate the availability of
this drug and are planning to begin filing a New Drug Application this
year. As our research continues we expect to submit for approval to FDA
drugs utilizing other technologies which will make them resistant to
oral abuse as well.
Purdue is especially concerned that school children do not
understand the potentially tragic consequences of abusing prescription
drugs. Purdue has consulted with experts in problems of drug abuse in
teenagers, and hired an agency that specializes in communication to
teenagers to develop a specific program targeted towards educating them
about the dangers of prescription drug abuse and diversion. These
materials have been reviewed with police officials and educators in
various states, and several thousand demonstration kits have been
distributed to those involved in teen drug awareness education. We call
the program ``Painfully Obvious'' and have established a website at
painfullyobvious.com. These materials have been piloted in test markets
in Florida, Pennsylvania, Ohio, and West Virginia. We are now
incorporating feedback and will start roll-out plans expanding the
program in those four states later this month, and in five new states,
including Maine, Massachusetts, and Virginia, by midyear. We want kids
to know that prescription drugs when abused can be every bit as
dangerous as street drugs. Materials from the Painfully Obvious program
are being furnished for the Record.
Purdue has worked with the FDA to strengthen warnings on
the OxyContin package insert and to communicate those
warnings to physicians throughout the country. Upon hearing of the
abuse and diversion of OxyContin, Purdue asked for a meeting
with the FDA to discuss the problem. The result of a series of meetings
with the FDA, involving Purdue's Chief Medical and Scientific Officer,
Chief Operating Officer, and General Counsel, in collaboration with the
FDA, was the development of a new package insert that could become the
standard for opioid analgesics. FDA has called upon other makers of
such drugs to reexamine their own package inserts and make similar
changes where appropriate. So far, we are aware of no company other
than Purdue that has made these changes. Purdue mailed a letter and new
prescribing information to 550,000 medical professionals throughout the
country. Our field force also reviewed the new labeling during their
calls on physicians. Dr. John Jenkins, who is also a witness at this
hearing, led FDA in a cooperative effort to work with us to develop
better labeling for drugs like OxyContin. We commend Dr.
Jenkins for this effort and call upon other pharmaceutical companies to
follow our lead and make similar changes to their product labeling.
In addition to the revised package insert, Purdue has
worked with the FDA to develop a special information leaflet intended
to be given by the physician or pharmacist to every patient receiving a
prescription for OxyContin. This leaflet has recently been
approved by the FDA and will alert patients to the risks of misuse and
abuse, and to the diversion issues. A copy of the text of that Patient
Information leaflet is being furnished for the Record. We are aware of
no other company that has produced such an informed and informative
patient information leaflet for a controlled substance.
Upon learning of the abuse and diversion problems in 2000,
Purdue immediately began efforts to understand the pattern of abuse.
Purdue developed a mathematical model that attempted to identify areas
where abuse potential was expected to be highest. Purdue used this
model as the basis for its ``100 County'' program. As part of the
program, company sales representatives were brought to Purdue's home
office specifically for the purpose of training them to actively
participate in stopping the abuse and diversion of OxyContin.
These training sessions were conducted with the assistance of the Drug
Enforcement Administration. The sales representatives attending the
training were told that, in the 100 counties where abuse potential was
highest, their goal was not to sell OxyContin. The sales
representatives were instructed to give the physicians additional
training regarding abuse and diversion and to provide additional tools
for proper pain assessment. If physicians were not willing to use these
tools, the sales representatives were instructed to ask them to stop
prescribing OxyContin for their patients.
During visits with several U.S. Attorneys and State
Attorneys General, Purdue learned that a significant source of
diversion was ``doctor shopping''--abusers and criminal diverters
fraudulently misleading doctors. Law enforcement officials believe that
those physicians require education and information to enable them to
avoid being misled. To deal with the problem, Purdue is sponsoring
significant educational programs specifically geared towards preventing
abuse and diversion, and is sponsoring abuse and diversion training
programs for thousands of additional doctors.
As part of its ongoing educational effort, Purdue has developed and
distributed brochures on prevention of abuse and diversion to virtually
all the physicians who prescribe, and pharmacists who dispense, opioid
analgesics in the United States. These brochures have been distributed
to over 500,000 doctors and 50,000 pharmacists, and copies are being
furnished for the Record.
Even before the current experience with
OxyContin abuse, Purdue had been providing physicians with
important information about the proper prescribing of opioid
analgesics. Our representatives have distributed opioid therapy
documentation kits since 1997 and over 250,000 copies of ``Model
Guidelines for the Use of Controlled Substances for the Treatment of
Pain'' (the ``Model Guidelines'') since early 1999. These materials
emphasize the need to properly evaluate patients and help teach
physicians about proper documentation and alert them to the
possibilities of abuse and diversion at the same time that proper pain
management is emphasized. The Model Guidelines were approved by the
Federation of State Medical Boards of the United States in May of 1998
after development by a blue ribbon panel and with the support of the
American Academy of Pain Medicine, the American Pain Society, the
American Society of Law, Medicine and Ethics, and the University of
Wisconsin Pain and Policy Studies Group. Copies of these important
documents are being furnished for the Record As the Model Guidelines
state: ``The Federation believes adoption [by State Medical Licensing
Boards] of guidelines based on this model will protect legitimate
medical uses of controlled substances while preventing drug diversion
and eliminating inappropriate prescribing practices.''
Purdue has developed a program to provide tamper resistant
prescription pads to physicians in 16 states that were deemed to have
the highest potential for abuse and diversion of OxyContin.
To date, we have funded over 7,500 orders from doctors requesting these
pads. Purdue is expanding this program to additional states. In
addition, to encourage use of these pads on a broad scale, Purdue is
conducting multiple mailings in selected states to encourage physicians
to order these pads.
Purdue has taken significant and escalating steps to
thwart diversion of its product from Mexico and Canada to the United
States. As initial steps, Purdue stopped shipping 40-milligram tablets
to Mexico, and changed the tablet markings on OxyContin
exported to Mexico and Canada to assist law enforcement in determining
country of origin in drug seizures. Following the theft of a
significant number of OxyContin tablets in Mexico City in
December 2001, Purdue halted all shipments of OxyContin to
Mexico.
Purdue has supported the efforts of law enforcement by
supplying placebo OxyContin tablets for ``reverse buy and
bust sting operations.'' In several areas, law enforcement has praised
these efforts as critical in their efforts to stop diversion. In one
hard hit area, the County Sheriff noted that our efforts were
instrumental in helping to reverse the course of OxyContin
abuse.
Purdue has initiated the development of a system to
monitor abuse and diversion of prescription drugs throughout the United
States. Currently, there is no monitoring system that adequately
measures abuse and diversion, especially in rural areas of the country,
where the abuse of prescription drugs is prevalent. Purdue has already
had several meetings of an advisory board comprised of distinguished
experts from law enforcement, addiction treatment, pain treatment, and
health policy fields. Several studies have been initiated as part of
this program to gain further information about abuse and diversion. In
addition, Purdue has met with NIDA and hopes to involve NIDA in the
development and operation of this system.
3. WHAT IS THE SOLUTION?
Perhaps the single most important tool to prevent abuse is
education. A survey released in December 2001 by the National
Association of State Controlled Substances Authorities (NASCA) reveals
that NASCA members believe that diversion education and pain management
education for prescribers are more effective than any other means of
combating prescription drug abuse. To that we would add--as our own
commitment to educational initiatives demonstrates--education of
youngsters, community leaders, non-prescriber health care professionals
and law enforcement personnel.
Education of healthcare professionals about the issues of
prescription drug abuse is critical. Education of responsible doctors
and pharmacists can arm them with the tools they need to stop diversion
from their practices. Purdue has assumed a leadership role. Educating
teenagers about the risks and dangers of prescription drug abuse is
critical, and we have taken an important step with our Painfully
Obvious program.
Better information is critical, and we have initiated efforts to
develop more reliable and timely information. A better information
system can allow us to know where abuse and diversion is cropping up
and allow timely medical education and law enforcement to act earlier
to nip these problems in the bud. It is critical that we all evaluate
the problem of OxyContin abuse in the context of the broader
problem of abuse of prescription drugs. The level of frustration over
the absence of good information defining the problem was notable at the
meeting of the Food and Drug Administration Anesthetic and Life Support
Drugs Advisory Committee held on January 30 and 31 to consider the
medical use of opioid analgesics (the ``FDA Advisory Committee
meeting''). The transcript of that hearing is not yet available, but it
is of such direct relevance to the subject of today's hearing that we
request the opportunity to submit it along with some additional
comments from Purdue for the Record when it becomes available.
Prescription Monitoring Programs (``PMPs'') would help. The PMPs in
Kentucky and Nevada can serve as useful models. PMPs can reduce doctor
shopping and diversion from good medical practices by giving physicians
a way to identify patients who are receiving controlled substances from
other doctors. Purdue supports the adoption by all states of
Prescription Monitoring Programs meeting appropriate standards. Purdue
encourages Congress to develop legislation to provide states with
incentives to adopt such PMPs. Purdue is eager to work with Congress to
develop and support such legislation. In addition, Purdue is prepared
to utilize its resources to explain the benefits of such a system to
physicians and to gain support for such legislation from the medical
community. We are submitting for the Record a copy of Purdue's policy
paper on PMPs that sets forth what we believe to be the attributes of a
successful program. Purdue is willing to devote promotional resources
to introduce such programs to physicians.
Tamper resistant prescriptions can reduce copying or alteration.
Development of abuse resistant products can reduce the incidence of
abuse.
Ultimately, solving the problem of prescription drug abuse requires
the cooperation of many elements in our community: law enforcement, the
schools, religious institutions, parents and family, the courts, the
medical community, the press, federal and state legislators, government
agencies, social services providers, and the pharmaceutical industry.
This is a long-standing societal problem that requires a reasoned
solution. Purdue is trying to help through our specific programs and
our cooperation with the other elements in the community, but we can't
emphasize enough that what is needed is cooperation and common purpose.
We would welcome the opportunity to work more directly toward a
solution with this Committee and with all others who are involved,
especially the DEA.
4. THE BENEFITS OF OXYCONTIN
The availability of OxyContin is critical for countless
patients who are suffering from moderate to severe pain where a
continuous around-the-clock analgesic is needed for an extended period
of time. Unfortunately for those patients, concern generated by the
abuse of OxyContin has mushroomed to the point of hysteria in
some locations, with the result that some patients are asking their
doctors to switch them to less effective drugs, some doctors are
refusing to renew patients' prescriptions for OxyContin and
some pharmacies are no longer willing to carry OxyContin for
their patients. This situation was described over and over by witnesses
appearing at the FDA Advisory Committee meeting.
While all of the voices in this debate are important, we must be
especially careful to listen to the patients who, without medicines
like OxyContin, would be left in pain. Purdue frequently
hears stories of how OxyContin has enabled people to return
to their families and to productive lives after suffering disabling
pain. We urge you to talk directly to some of those patients. They are
not addicts. They are not criminals. They are people who, because of
cancer, sickle cell anemia, severe back injuries, or some other
physical insult or disease have had their lives taken away from them by
unrelenting pain. There were many powerful examples presented at the
FDA Advisory Committee meeting that we will reference for the Committee
when the transcript becomes available.
Amidst all the publicity and controversy, a few facts stand out.
First, the problem of chronic pain in this country is
enormous and expensive. According to organizations like the American
Pain Foundation, an estimated 50 million Americans suffer from chronic
pain, with a cost approximating $100 billion a year attributable to
lost workdays, excessive or unnecessary hospitalizations, unnecessary
surgical procedures, inappropriate medication and patient-incurred
expenses from self-treatment. But even those staggering numbers fall
far short of capturing the essence of chronic pain in America. Pain
cannot be expressed in numbers. It is individual and it is personal. It
is intense. It is debilitating. It destroys the capacity to perform
life's simplest functions and can even destroy the will to live. Anyone
who has cared for a loved one in pain knows more about the impact of
pain than I can ever describe. For those fortunate enough not to have
experienced pain themselves or to have cared for a sufferer, let me ask
you to imagine a life in which you can't go to work, take a walk, pick
up your child, hug your spouse or even kneel in prayer. That can be the
life of a chronic pain sufferer.
Second, chronic pain has been historically under treated.
Only in this past decade has public and medical opinion swung
decisively in the other direction, based on the proven effectiveness of
individualized therapy, including opioids, in treating pain, and the
startling improvement in quality of life such therapy offers to
patients.
--In 1994, the Department of Health and Human Services issued new
guidelines encouraging the use of opioids in the treatment of cancer
pain.
--In February of 1999, the Veterans Administration added pain as a
fifth vital sign (along with pulse, temperature, respiration, and blood
pressure) that should be checked regularly as a major indicator of
health.
``VA officials said the change in routine is designed to call
physicians' attention to what is widely considered one of the
most unrecognized and untreated symptoms in American health
care. In a study of 10,000 dying patients published in 1995 in
the Journal of the American Medical Association, for instance,
researchers found that almost half died in severe pain; other
studies report that as many as three-quarters of advanced
cancer patients are in pain.'' Washington Post, February 1,
1999.
Many other healthcare professionals and organizations have adopted
this practice of checking pain as a fifth vital sign.
--On October 28, 2000, Public Law 106-386 was enacted declaring the
decade commencing on January 1, 2001 to be the ``Decade of Pain Control
and Research.'' Bills currently pending in both the House and Senate
(The Conquering Pain Act of 2001, S. 1024 and H.R. 2156) recognize that
``chronic pain is a public health problem affecting at least 50,000,000
Americans,'' and seek long-lasting changes that would enable all
Americans to effectively manage medical conditions associated with
chronic pain.
Third, OxyContin is widely recognized as a
highly effective treatment for pain. When properly used under the
supervision of a physician, it is also an extremely safe medication.
Its twelve-hour controlled-release mechanism affords an extended dose
of pain medication, allowing patients to sleep through the night and to
avoid sharp spikes in blood levels of medicines that can cause side
effects. Many patients have told their doctors and Purdue that
OxyContin has given them back their lives. Purdue is
furnishing for the Record representative communications that it has
received from patients and their families describing the importance of
OxyContin in managing their pain, along with a paper prepared
by Pinney Associates, Inc. that describes OxyContin's
importance to public health.
5. WHAT IS OXYCONTIN?
No legal drug in the United States is more rigorously regulated
than OxyContin. It is a Schedule II drug under the Federal
Controlled Substances Act. OxyContin is monitored by state
and federal health and law enforcement officials in its production,
marketing, distribution, and prescription. Both the FDA and DEA oversee
OxyContin.
The sole active ingredient in OxyContin is oxycodone, a
semi-synthetic opioid first developed in 1916. Oxycodone has been sold
in various forms in the United States for over 60 years. Percodan,
Percocet, and Tylox are examples of oxycodone products. Typically, but
not always, these forms of oxycodone have been combined with a co-
analgesic agent such as aspirin or acetaminophen (Tylenol), in which
case they are referred to as ``combination analgesic products''. In
large doses those non-opioid analgesics may be toxic to the liver,
stomach and kidneys. Therefore, drugs containing either aspirin or
acetaminophen are limited in their usefulness because a patient can
only take up to a set amount per day to avoid aspirin or acetaminophen
toxicity. Even if a patient needs more pain relief, the non-opioid
component limits the maximum dose of the combination analgesic. The
medical profession made it clear to us that it wanted oxycodone in a
controlled-release form without any other active ingredients that could
impose limits on the dose a patient could take in a day. Purdue
responded by introducing OxyContin tablets in December 1995.
Because of the efficacy of this single entity, controlled-release
product, doctors have found OxyContin extremely effective in
properly managed programs of pain treatment.
6. WHO IS PURDUE PHARMA?
Purdue Pharma is a privately held pharmaceutical company founded by
physicians. Purdue's headquarters are in Stamford, Connecticut.
OxyContin is manufactured at facilities in Totowa, New Jersey
and Wilson, North Carolina.
Family ownership of Purdue and its associated companies began with
the purchase of The Purdue Frederick Company in 1952. In those early
days, Purdue's main products were Betadine antiseptics and Senokot
laxatives. Since the early 1980s, Purdue has focused its research and
development efforts primarily on medications for pain management. One
of the most significant advances introduced by Purdue is the use of
controlled-release opioid analgesics for the treatment of moderate to
severe pain. Controlled-release opioid analgesics, pain medicines which
last for 12 hours or more, enable patients to sleep through the night
and provide better control of pain than drugs that require dosing every
4 to 6 hours. Purdue introduced MS-Contin tablets, a controlled-release
form of morphine, in 1984, and a controlled-release oxycodone product,
OxyContin tablets, in December 1995.
Since 1984, Purdue has worked diligently to inform doctors and
other healthcare professionals about appropriate use of opioid-based
medicines. This has required a significant investment, as medical
schools have traditionally spent little time teaching doctors how to
assess and treat pain or how to use our best medicines for moderate to
severe pain. For example, when Purdue started selling opioid analgesics
in 1984, many doctors were not aware that morphine could be given
orally as a treatment for pain. Today, administration of oral
controlled-release morphine is considered standard practice for the
treatment of cancer pain.
Purdue has extensively studied the use of these medicines in the
treatment of moderate to severe pain associated with both malignant and
various non-malignant diseases. Such pain requires a careful assessment
of the patient and an individualized treatment plan. There are many
important therapeutic modalities including opioid analgesics. Without
opioid therapy, many patients suffer and are disabled. Purdue's
clinical research has provided valuable experience and data to guide
physicians in properly using these medicines; for example, on
determining the proper dose and dealing with side effects.
7. PURDUE'S PROMOTION AND MARKETING OF OXYCONTIN TABLETS
Purdue's marketing of OxyContin tablets has been
criticized for being overly aggressive thereby possibly contributing to
excessive abuse. The criticisms have ranged from charges that Purdue
gave doctors ballpoint pens containing conversion charts to allegations
that Purdue marketed OxyContin as a more effective
replacement for less addictive drugs. Conversion charts with
information similar to that contained in the pen are distributed by
most pharmaceutical companies and many prestigious medical
institutions. The pen/conversion chart is an essential informational
tool to be used only after the physician has determined that
OxyContin is appropriate therapy for the patient.
The notion that these conversion charts are an attempt to encourage
physicians to switch patients to OxyContin from less abusable
drugs is unfounded. These charts are intended, and understood by
physicians, to be used when those lower scheduled drugs are not
working. Physicians understand that with all classes of medicines, if
patients are doing well on their current regimen, then that regimen is
not to be changed. If, however, the patient still has significant pain
despite the use of other medicines and the physician has made a
determination that OxyContin is worth trying for that
patient, then this chart merely helps the physician choose the proper
dose.
Purdue is scrupulous in training its field sales force to promote
OxyContin only for its approved indications. Under any
circumstance, recognize for a moment that even if marketing prompts a
legitimate but misinformed doctor to inappropriately prescribe
OxyContin to a legitimate patient (which should never
happen), that surely is an insignificant part of the problem of
OxyContin abuse. Reports of patients becoming addicted to
OxyContin are rare. That would not excuse aggressive
marketing, but blaming the drug abuse problem on aggressive marketing
is unjustified. Purdue's marketing practices have not played a role in
the criminal activities of doctors who illegally prescribe
OxyContin in exchange for cash, and have not encouraged
robberies from pharmacies or from patients.
OxyContin tablets are not promoted to consumers. The few
advertisements that appear are solely in medical journals. Rather than
promoting aggressive marketing, Purdue's marketing practices focus on
teaching doctors to only prescribe OxyContin in appropriate
circumstances. Purdue managers monitor its field force for compliance
with that policy. Sales representatives are told that in the event of a
violation of our marketing policies, the offender will be subject to
discipline, up to and including termination.
(a) Marketing for appropriate use.
Purdue's sales and marketing practices focus exclusively on the
management of pain and the proper use of OxyContin in
patients for whom such a pain medication is appropriate. Our marketing
program amounts to an extensive educational effort that teaches
physicians how to make the best decisions for their patients with pain.
Responsible physicians will only prescribe OxyContin if it is
the right product for their patients with pain. From time to time,
after a physician has decided that OxyContin is the right
prescription for his or her patient, we have underwritten the cost of
the patient's prescription for the first week of therapy. In this way,
the physician and patient could decide if OxyContin was
working for that particular patient. We have never provided samples to
patients or physicians.
In fact, Purdue's marketing has encouraged physicians to take
actions that would reduce the abuse and diversion of
OxyContin. Purdue has asked physicians to carefully:
--Prescribe only the quantity of product that the physician deems
necessary based upon a complete history and physical examination and
careful assessment of the patient's pain;
--Determine that the nature and severity of the patient's pain
requires an opioid analgesic for an extended duration;
--Prescribe a quantity of medicine based upon the dosage that the
patient requires; and
--Follow up carefully with each and every patient on a regular
basis.
An example of Purdue's efforts to promote only appropriate use of
the drug in appropriate patients is the use of various medical
guidelines that were incorporated in the original package insert and
distributed by our field force, including those from the World Health
Organization, the Agency for Healthcare Policy and Research, and the
American Pain Society. As these guidelines evolved, Purdue distributed
revised versions to keep physicians up to date. The original package
insert is quite clear regarding the appropriate use of
OxyContin, and we were quite clear in promoting the use of
OxyContin in a manner consistent with this package insert. In
the Precautions section it states:
Selection of patients for OxyContin should be
governed by the same principles that apply to the use of
similar controlled-release opioid analgesics . . . Physicians
should individualize treatment in every case, using non-opioid
analgesics, prn [on an as needed basis] opioids and/or
combination products, and chronic opioid therapy with drugs
such as OxyContin in a progressive plan of pain
management such as outlined by the World Health Organization,
the Agency for Healthcare Policy and Research, and the American
Pain Society.
As noted in Section 2, other examples of Purdue's efforts to
promote only appropriate use of the drug in appropriate patients and to
caution physicians against indiscriminate use include Purdue's
distribution to physicians of opioid therapy documentation kits,
brochures on prevention of abuse and diversion, and the Model
Guidelines. A reading of the Model Guidelines makes clear that rather
than encouraging indiscriminate use of OxyContin, Purdue's
educational efforts were directed at teaching physicians how to use
these drugs responsibly and appropriately for appropriate patients. For
example, the Model Guidelines provide:
``All physicians should become knowledgeable about
effective methods of pain treatment as well as statutory
requirements for prescribing controlled substances.''
``The Board recognizes that inappropriate prescribing
of controlled substances, including opioid analgesics, may lead
to drug diversion and abuse by individuals who seek them for
other than legitimate medical use. Physicians should be
diligent in preventing the diversion of drugs for illegitimate
purposes.''
``All such prescribing [of controlled substances] must
be based on clear documentation of unrelieved pain and in
compliance with applicable state or federal law.''
``The physician should discuss the risks and benefits
of the use of controlled substances with the patient. The
patient should receive prescriptions from one physician and one
pharmacy where possible. If the patient is determined to be at
high risk for medication abuse or have a history of substance
abuse, the physician may employ the use of a written agreement
outlining patient responsibilities.''
``Special attention should be given to those patients
who are at risk for misusing their medications and those whose
living arrangements pose a risk for medication abuse or
diversion. The management of pain in patients with a history of
substance abuse or with a comorbid psychiatric disorder may
require extra care, monitoring, documentation, and consultation
with or referral to an expert in the management of such
patients.''
In distributing the Model Guidelines, Purdue was fulfilling an
important responsibility to educate physicians in the appropriate use
of OxyContin and other opioid analgesics. Such guidelines
were just being developed by the medical community as the pain movement
grew and the need to treat patients in pain was recognized. As these
and other guidelines were developed we added them to our educational
efforts. While some may characterize these activities as ``aggressive
marketing,'' we believe that our efforts to alert the medical community
to the vast under treatment of pain in the United States and to the
fact that opioid analgesics such as OxyContin had a role to
play in appropriate patients, was in fact in the interest of the public
health.
(b) Healthcare professional education.
Purdue sponsors extensive training for the medical community. There
is widespread consensus that medical practitioners, in the course of
their medical education, receive limited and often inadequate training
in the management of pain. Physician education has always been a
principal feature of Purdue's marketing and medical education efforts.
As early as 1984 we saw that physicians wanted and needed more
information about how to assess pain in their patients, how to
determine the right dose of pain medicine, how to treat side effects,
and more recently, how to deal with the risks of abuse and diversion.
At the outset we realized that this task required us to create a highly
professional and highly trained field force supported by an extensive
medical education effort.
(c) Purdue's training of its sales representatives.
Virtually all of Purdue's field force is recruited from within the
pharmaceutical industry. New sales representatives, despite their prior
experience, are enrolled in a 26-week training program, which includes
three weeks of classroom training at the home office. Sales
representatives are given extensive training in the principles of
proper promotion of pharmaceutical products. They are directed to
promote only those uses of our products which are approved by the FDA
and to use only those promotional materials which are approved for use
after rigorous medical, regulatory and legal review. During this
training, representatives are told that our standard of conduct is that
during every sales call they should act as if they were accompanied by
an FDA inspector. Upon returning from their home office training, new
representatives are closely monitored by their managers who will spend
time in the field, visiting doctors with them. In addition, field
trainers from the local area and the home office will often accompany
new representatives.
Moreover, in July 2001, Purdue established a telephone ``hot line''
to receive comments from any physician who believes a Purdue sales
representative has in any way promoted our products in an inappropriate
manner. Purdue knows of no other pharmaceutical company that has gone
to such lengths to insure that on a day-to-day basis its sales
representatives comply with the high standards that are established
during their training. The results have been reassuring; rather than
being critical, the vast majority of calls to the hot line have
complimented the professionalism of our sales representatives.
(d) Limit on sales commissions.
In response to requests from law enforcement officials, Purdue has
changed its variable compensation plan. When Purdue visited with U.S.
Attorney Crouch of Virginia, a concern was expressed that Purdue's
incentive plan for its sales personnel enabled a representative to earn
large commissions as a result of the prescribing practices of any
single doctor. Purdue was asked to consider changing this aspect of its
variable compensation plan. Purdue investigated how this could be done
while dealing with the technical complexity of carrying out such
computations for thousands of doctors and keeping faith with its
relationship with its sales employees. These problems were resolved and
such a cap on commissions from prescriptions of any one physician is
now in place.
8. WHAT IS THE SOURCE OF DIVERTED OXYCONTIN?
According to law enforcement experts, OxyContin and other
legitimate prescription drugs find their way into illicit channels by
means of prescription fraud, ``doctor shopping'', physicians criminally
selling prescriptions, theft from patients or pharmacies, diversion
from Mexico, Canada, and Internet pharmacies. Unfortunately, several
months ago Purdue had an incident that we are aggressively addressing.
OxyContin tablets are manufactured in two locations. Despite
a 17 year history of manufacturing controlled substances without an
incident of theft, earlier this year Purdue discovered that two company
employees had stolen OxyContin tablets from the production
line at the Totowa, New Jersey plant. Manufacturing officials
immediately notified local police and the DEA and terminated the
employment of these individuals, who were taken into custody by the
police. The company as well as the local police, DEA, and FDA are
conducting further investigations and Purdue is fully cooperating with
these law enforcement agencies. All internal security procedures have
been analyzed and any weaknesses are being addressed.
9. COULD PURDUE HAVE FORESEEN THE PROBLEM?
In the past two decades, a variety of opioid analgesics containing
sufficient amounts of morphine-like drugs to be subject to abuse and
addiction have been marketed as Schedule II controlled substances and
have been associated with a limited amount of abuse and diversion.
Examples of such drugs include Demerol (meperidine hydrochloride),
Duragesic (transdermal fentanyl), Dilaudid (hydromorphone) immediate
release morphine preparations, and immediate release oxycodone
preparations. In addition, for some 17 years Purdue has marketed MS-
Contin (morphine sulfate controlled-release), a drug with abuse
potential similar to OxyContin that is available in a single
tablet at doses as high as 200mg. It is significant that there have
been no unusual signals throughout the marketing of MS-Contin that
would suggest that this controlled-release dosage form would be
particularly attractive to abusers. Purdue had no reason to expect
otherwise with OxyContin. Neither Purdue, nor the FDA, nor
the DEA, nor the medical community anticipated the extent of this
problem, which surfaced in February 2000 with reports of abuse or
diversion in rural parts of Maine.
10. HOW WIDESPREAD IS THE PROBLEM OF OXYCONTIN ABUSE?
Both Purdue and law enforcement are trying to understand the extent
of this problem. Initially, the abuse of OxyContin tablets
was concentrated in a few parts of a few states, generally along the
spine of Appalachia, where abuse of other prescription drugs has long
been a problem due to many factors, including poverty and lack of
opportunity. In those areas the problem of the abuse of
OxyContin is serious. Today, the geographic scope is broader.
Regrettably, widespread media attention may have contributed to this
wider geographic scope by calling to the attention of potential abusers
in all parts of the country that OxyContin is a desirable
drug of abuse.
The real issue here is prescription drug abuse. To emphasize that
point, DEA Administrator Hutchinson was quoted in the February 6, 2002
New York Times as making the following statement about methamphetamine:
``I would call it the No.1 drug problem in rural America.''
OxyContin is a part of this larger problem. The table which
follows is the most recently available annual data published by the
U.S. Government's Drug Abuse Warning Network (DAWN) for several of the
drugs mentioned most frequently in all drug-related Emergency Room
visits in which abuse was suspected in 2000.
------------------------------------------------------------------------
Number of Percent of
Drug Mentions Total Episodes
------------------------------------------------------------------------
Cocaine................................. 174,896 29.06
Marijuana/Hashish....................... 96,446 16.03
Acetaminophen........................... 33,613 5.59
Hydrocodone............................. 19,221 3.19
Diazepam................................ 12,090 2.01
Oxycodone............................... 10,825 1.80
------------------------------------------------------------------------
Furthermore, not only were hydrocodone incidents considerably
higher than oxycodone in 2000, earlier DAWN data shows virtually
parallel rising trend lines since the introduction of
OxyContin through 2000 in the growth of both hydrocodone and
oxycodone.
Additional data were collected in 2000 for various drug categories
by the National Household Survey of Drug Abuse (NHSDA) that helps to
provide some indication of the scope of the problem. Among the pain
relievers, there were specific data included for a number of drugs,
including OxyContin. The NHSDA concluded that the non-medical
use of OxyContin was rare in 2000, but acknowledged that the
data showed evidence of an emerging problem. The relative numbers of
non-medical use of common pain relievers acknowledged to have been used
by persons 12 years of age and older during their lifetimes were
striking. Hydrocodone non-medical use was more than four times greater
than OxyContin; Demerol was more than five times
greater; non-medical use of Vicodin, Lortab or
Lorcet was more than 16 times greater than
OxyContin; Percocet, Percodan, or
Tylox was 16 times greater; and non-medical use of
Darvocet, Darvon, or Tylenol with codeine
was 34 times greater than OxyContin.
It remains difficult to obtain hard evidence on the extent of
OxyContin abuse. As a result of a recent survey of Medical
Examiners, the DEA categorized a tragic number of deaths associated
with oxycodone in 2000 and 2001 as either ``OxyContin
verified,'' 117, or ``OxyContin likely,'' 179.
OxyContin is the drug of the hour, and the DEA acknowledged
that the media has attributed hundreds of deaths to OxyContin
that cannot be verified. Even in those deaths that were
``OxyContin verified,'' the DEA acknowledged that in the
majority of them toxicological screens reflected polydrug use, in other
words, an ingestion of a ``cocktail'' of legal and illegal drugs, and
frequently alcohol as well, in the blood of the decedent. In these
cases, death is usually attributed to the abuse of multiple drugs.
Unquestionably OxyContin is being abused, and Purdue
accepts its responsibility to help address the problem. But just
because OxyContin may be the drug of the hour, focusing on
OxyContin without attempting to address the broader problem
of prescription drug abuse would be unfortunate. Statistics should not
be used to minimize the tragedy of even a single loss of life, but they
help demonstrate the complexity of this problem. In recent months we
have seen several reports suggesting that the problem of
OxyContin abuse may have crested in some areas and that it
continues to be regional and is not spreading. We do not offer this
information as definitive, but it provides encouragement that the
concerted efforts of law enforcement, the medical community and Purdue
might be bearing fruit. We would welcome the opportunity to share this
data with the Committee.
11. IS RESTRICTING THE USE OF OXYCONTIN THE SOLUTION?
Some have suggested that restricting availability of
OxyContin will help alleviate the problem. We are convinced
this is not so. Those intimately involved with the problem agree. Local
law enforcement officers have told us that in most of the reported
cases of overdose and death, OxyContin was neither the first
nor the sole drug abused. Knowledgeable law enforcement officers have
said that if OxyContin were not available, those abusing and
diverting drugs would not stop their behavior, but would simply
transfer to other legal and illegal drugs. We have been advised by law
enforcement officials that when effective measures have reduced the
availability of OxyContin to abusers and diverters, they
return to their prior drugs of abuse. For this reason, the only real
impact of restricting the availability of OxyContin tablets
would be to make it more difficult for the legitimate patients who
benefit from this drug to obtain it.
At the FDA Advisory Committee meeting, the point was made
repeatedly that if the prescribing of drugs like OxyContin
was limited to pain specialists, countless patients in pain, and
certainly a high percentage of the rural, under-served, and low
economic status population, would have no adequate treatment available
to them. We will reference that information for the Committee when the
transcript of the FDA Advisory Committee meeting is available. Perhaps
the overriding message to emerge from the FDA Advisory Committee
meeting was that there is no easy solution, no ``silver bullet'' that
will solve the problem being addressed by this hearing today, balancing
the risks and benefits of OxyContin.
12. CONCLUSION
Purdue is committed to fighting abuse and diversion of controlled
medicines. Abuse and diversion harm the abusers. They harm patients
with pain. They harm the cause of pain management, and they harm Purdue
and its products. Importantly, abuse and diversion threaten sound
health policy, whose course should be driven by the health needs of
millions of patients, not the actions of diverters.
The dilemma of addressing the problems of abuse and diversion
without restricting the sale of a controlled drug like
OxyContin to meet the needs of doctors and patients for the
effective management of pain was the subject of an important event in
Washington, D.C. this past fall. On October 23, 2001, the DEA joined
with 21 health organizations and issued a joint statement, a copy of
which is being furnished for the Record, addressing the complex issue
of combating prescription drug abuse while protecting the medical needs
of patients. The Joint Statement expressly recognized:
Undertreatment of pain is a serious problem in the United
States, including pain among patients with chronic conditions
and those who are critically ill or near death. Effective pain
management is an integral and important aspect of quality
medical care, and pain should be treated aggressively.
and also acknowledged what we at Purdue know all too well:
Drug abuse is a serious problem. Those who legally manufacture,
distribute, prescribe and dispense controlled substances must
be mindful of and have respect for their inherent abuse
potential. Focusing only on the abuse potential of a drug,
however, could erroneously lead to the conclusion that these
medications should be avoided when medically indicated
generating a sense of fear rather than respect for their
legitimate properties.
Today's hearing is an important step to paraphrase the Joint
Statement in the direction of preventing drug abuse while not hindering
patients' ability to receive the care they need and deserve.
The management of pain is a critical priority of healthcare in this
country. Chronic pain affects as many as 50 million Americans and costs
the country $100 billion annually. OxyContin has proven
itself an effective weapon in the fight against pain, returning many
patients to their families, to their work, and to their enjoyment of
life. That advance should not be stunted or reversed because of the
illegal activities of those who divert and abuse the drug. We cannot
turn back the clock. The answer to these problems is increased
education, information and enforcement, not restrictions that will deny
patients effective treatment of their pain.
response from dr. goldenheim to a question asked by senator reed
Purdue Pharma L.P.,
Stamford, CT 06901-3431,
February 26, 2002.
Hon. Edward M. Kennedy,
U.S. Senate,
Washington, D.C. 20510.
Dear Chairman Kennedy: At the February 12, 2002 hearing of your
Committee on the subject of OxyContin, Senator Reed asked me
about Purdue Pharma's marketing of MS-Contin. I was not able
to fully answer his question at the time, but agreed to furnish that
information for the Record.
Purdue continues to sell MS-Contin, but our patent
protection has expired and as is customary in the pharmaceutical
industry for drugs facing generic competition, we are no longer
actively promoting it. While we were still actively promoting MS-
Contin, our marketing activities were similar to that for
OxyContin. Except for the initial launch period for
OxyContin and the fact that MS-Contin has never
been subject to a cap on commissions available to sales
representatives, the compensation plan for our sales representatives
has been virtually the same for the two medicines. The literature,
mailings, and advertising for MS-Contin were comparable to
those for OxyContin, but since the overall sales of
OxyContin are larger, we spend more on the promotion of
OxyContin when measured in absolute dollars and less as a
percentage of sales.
If you have any additional questions, please let me know.
Sincerely,
Paul D. Goldenheim, M.D.,
Executive Vice President,
Worldwide Research & Development.
______
Senator Reed. I would like to first turn to the
practitioners, Dr. Payne and Dr. Van Zee and Ms. Green. It
seems to me that one of the critical elements in this situation
is the physician knowing their patient and prescribing
appropriately what is a very serious narcotic. This is not
something I would assume you would prescribe lightly. As a
physician, you would have to believe that the person was in a
great deal of pain, that other treatments would not work, etc.
However, it strikes me from listening to the dialogue here
and especially some of the points Lieutenant Bess made about
people targeting physicians who prescribe liberally that the
solution might be better controls on physicians and greater
responsibility by physicians prescribing OxyContin, Dr. Payne
and Dr. Van Zee and Ms. Green?
Dr. Payne. I think you are absolutely correct that the
issue is physicians making adequate and appropriate assessments
of pain and then crafting an appropriate treatment plan. And
the issue here with drugs being abused is not so much with the
drug per se but with the people prescribing it and the people
using it because, as I said, there is very little evidence
actually that any one opiod is more inherently abusable than
any other opiod.
So all of the clinical practice guidelines, and in my
written testimony I have stated that there have been Federal
panels now which have looked at evidence and created clinical
practice guidelines for physicians, all emphasize this fact,
that appropriate pain assessment should precede appropriate
treatment and a critical aspect of pain assessment is knowing
the patient and in crafting a plan that not only helps relieve
pain but improves the patient's ability to function. So yes, it
is critical to know the patient.
Senator Reed. And Dr. Van Zee, I have to assume you know
every physician in Lee County. Is that a fair assumption?
Dr. Van Zee. There is a small number, yes, sir.
Senator Reed. So, where are all these young kids who--I
agree with you, whose lives are being ruined, getting access to
this OxyContin if your colleagues are as attentive as you are?
Dr. Van Zee. Well, that is a complicated problem and one
does not know the answer. Now the black market and diversion
market is so sophisticated now that it can hire nine commanders
to stage a major robbery in Mexico City, which happened in the
last 2 months in which there was a huge amount of OxyContin
taken that way.
I certainly share some of Dr. Payne's feeling about the
extreme importance of physicians being most careful about
knowing their patients very well and then being most careful
about their assessment, diagnosis and treatment. I think in
addition to a prescription drug monitoring program, which most
people are advocates of, I think as part of that component you
need to have some kind of physician profiling, as well.
Prescription drug monitoring will tell you if patients are
visiting multiple doctors. Most of those may not have a way to
recognize if one physician is extraordinarily overprescribing
this drug.
I would foresee that as some kind of computerized database
going into the State board of medicine, not law enforcement,
and there would be some kind of template that could be used to
look at on-going data so if we find physicians like has been in
this kind of tragedy, enormously overprescribing,
misprescribing this drug, that we do not find out about it two
and 3 years later after ultimate problems have developed.
Obviously if somebody is way off the curve in terms of
their opiod prescribing, that does not in any way necessarily
mean that they are misprescribing. It may mean that they are a
pain management specialist that has taken on multiple difficult
patients which many other physicians do not want to do. But it
means that if you are a far-out blip on the curve and that is
the scope of your practice, you are going to accept the fact
that you are going to be reviewed and that you would be
reviewed by the State board of medicine.
And a good practitioner has absolutely nothing to hide. I
mean there is a very important role for opiods in chronic
nonmalignant, which has been testified today. What is just not
known about is what subpopulation of people needs to get it,
what are the risks of receiving opiods, what are the benefits,
and those kinds of things we have very little data about.
Senator Reed. Thank you, Dr. Van Zee.
Ms. Green, do you have a comment from your perspective as a
nurse-midwife?
Ms. Green. As a nurse-midwife I do not prescribe OxyContin.
Senator Reed. No, but you have patients who apparently have
access to it.
Ms. Green. My patients have access to it through illegal
diversion. It is not prescribed to them. As far as I know, no
one in our county has prescribed OxyContin to a pregnant woman.
Senator Reed. So they would buy from someone else.
Ms. Green. They obtain it illegally through the diversion.
But I concur with comments being made as far as physicians in
rural communities, in particular. You know, we have to drive
two hours to a tertiary care center through very difficult road
conditions for a specialty. So we have family physicians and
internal medicine providers in our community that I think are
very vigilant now of their prescription habits in particular
with OxyContin. Several years ago we did have a physician who
is no longer practicing in Washington County that was writing
prescriptions for OxyContin, as they say, like candy.
The other issue that I think really needs to be looked at
is family physicians know their patients in the office--no
question about that. But family physicians cover the emergency
room; they do not know these patients. So I think having the
monitoring system in an emergency room so that a physician can
gather that information, of has this patient been going to Drs.
A, B, and C and likewise the emergency rooms and obtaining the
same prescription would be very, very valuable.
Senator Reed. Thank you.
Lieutenant Bess, as a police officer in rural Virginia, you
are investigating this abuse constantly. Your perception about
how most people are getting hold of their OxyContin, is it from
a physician, a misprescription, or are they obtaining it
through other means?
Lt. Bess. It is a combination of both the doctor-shopping,
which puts a significant amount out, and those few doctors who
do overprescribe, in effect, become pill mills and put a large
quantity of drugs on the market.
Mr. Price is working with the State and Federal task force
in Southwest Virginia called Operation Octagon. He has been
investigating continuous doctors since 1997 and as they close
out a case on one or two doctors, others have already been
added into that.
Special Agent Cameron is working in Northern Virginia with
a Federal task force called Operation Cotton Mouth, which is
finding the same thing. They are about to form a State and
local task force to work in the Northern Virginia area.
With regard to the database being in the board of medicine,
we feel that it would be better served to be in a law
enforcement agency because it is going to reveal criminal
activity, not regulatory misconduct. And while they could have
access to it, the main thing we would be looking at is the
criminal conduct that it would reveal by those doctors who are
outside the curve, as Dr. Van Zee speaks of.
The thing that doctors and health care professionals need
to be aware of is that the volume that they prescribe is never
the basis of why a physician is targeted by our group. That is
the last thing we look at. We look at what type of practice
they are involved in and what types of drugs they are
prescribing. For instance, we know that some people require
valium before they will go to a dentist's office and sit in
that chair and two valium every 6 months is not going to be a
problem. When we start seeing 300 every 2 weeks, that is a
serious dental problem and we might take a look.
We understand that veterinarians prescribe human medicine
to dogs. We know that oxycodone is not an appropriate thing; it
is not taught by the veterinarian schools. So when we see Rex
or Tabby getting prescriptions for Percoset or OxyContin, we
are probably going to take a look at that individual.
Poor judgment on behalf of the physician by overpresribing
is not going to draw our attention. It may get him lunch with
his board but it will not get him investigated by us.
Senator Reed. Thank you.
Let me change the subject just a bit and direct a question
to Dr. Goldenheim before I yield to my colleague, Senator
Collins.
There has been a suggestion, Doctor, that your marketing
techniques have been very aggressive with respect to OxyContin,
that you have identified and targeted physicians that heavily
prescribe opiods. The suggestion is that there is a connection
between selling OxyContin and compensation of your sales force.
I want to give you an opportunity to respond to those specific
issues, or anything else you think is appropriate in terms of
your marketing techniques.
Dr. Goldenheim. Thank you, Senator. I assume by aggressive
you mean improper marketing and----
Senator Reed. No, I just think it is that your company
believes you have a great product and you want to get it out
and are spending a lot of money to get it out. It might be
proper or improper.
Dr. Goldenheim. We have focussed on patients who already
have significant experience prescribing narcotic analgesics and
the reason for that is, as has been mentioned here, some
physicians are comfortable treating pain patients and have
experience and knowledge and others do not.
Our promotion has consisted of providing information for
physicians and pharmacists--that has been the case since 1984
when we launched MSContin, which was talked a little bit about
earlier today--because we recognize that the health care
profession needed more information about proper pain
management. That is why we focussed, for example, on handing
out guidelines that have been produced by prestigious medical
societies. That is why we have underwritten so many seminars
and symposia at which many preeminent pain experts have spoken,
including people like Dr. Payne and Dr. Portenoy, who have
submitted written testimony.
So our focus has been on teaching people about how to
properly use these medicines and increasingly, of course, we
have focussed on teaching physicians and pharmacists how to
avoid abuse and diversion.
Just to clarify one thing that came up earlier, no, we have
never done any direct-to-consumer advertising. And every time
we have seen anything pop up on the Internet, a site that is
offering free OxyContin or whatever, we have immediately phoned
the DEA to let them know.
The last thing I would just point out, and I think it has
been made clear today, is that this is part of a larger
problem. It is part of a prescription drug abuse problem. And
if you look at all of the diversion in Virginia, for example,
that has been collected by the DDU, the Drug Diversion Unit, as
we have heard, oxycodone preparations are, in fact, not number
one on that list for the last year.
In certain parts of Virginia obviously it has had
devastating consequences and in Maine, even in Washington
County, which has clearly been devastated by this problem and
we have heard these very poignant stories. It is my
understanding that hydromorphone or Dilaudid was and remains
one of the most important drugs of abuse and I think we heard
that from SAMHSA. This is a very big, very broad, very deep-
rooted problem.
Senator Reed. Well, no one can disagree with the fact that
it is a broad problem that goes beyond your product. It is
about abusing prescription drugs.
I am going to ask one more question, if I may, and turn it
over to my colleagues and then if we need a second round, we
will do a second round.
Are you still marketing MSContin?
Dr. Goldenheim. Yes, sir.
Senator Reed. Are you marketing it with the same kind of
campaign you are using for OxyContin--the same compensation
scales, the same literature, the same sort of advertising?
Dr. Goldenheim. I am not sure I can fully answer those
questions today. I believe that it is fairly similar but I
would have to get more specific information for you.
Senator Reed. Thank you, Doctor.
Senator Collins?
Senator Collins. Thank you, Mr. Chairman.
Ms. Green, I suspect that many of your addicted patients
would never have considered trying heroin, for example. Is that
correct?
Ms. Green. That is correct.
Senator Collins. So what is it about OxyContin that made it
so attractive? You are treating a high-risk, vulnerable
population because pregnant women obviously are a large part of
your practice.
Ms. Green. Through all these months of work that I have
done with addicts and mothers that are addicted, I have
certainly learned a lot about addiction, although I am not an
expert like everyone else. However, I think it is the purity
and the dose of OxyContin. It is the safety. It is prescribed
by the physician. It is legal, unlike heroin, when they do not
know what purity levels they are getting.
What I am told from the community is that there is a food
chain among addicts. At the top of the food chain is the person
that snorts OxyContin. They are the top. They are the elite.
The next level down is those that use IV OxyContin. The next
level down is the women that use sexual favors in exchange for
OxyContin and last it is the heroin addicts. There is a stigma
with heroin and cocaine but there is not with an opiate.
Senator Collins. And that lack of stigma also translates
into a lack of an alertness to the danger, does it not?
Ms. Green. Over and over and over again I am told by these
women in particular and not just women that I care for but
young men, as well, it was written by a doctor, it is legal, I
know what is in it, so I'm going to use it and it is okay to
use.
They did not realize--I had a woman in labor who had
snorted 2 days before she went into labor and said to me she
had no idea that OxyContin was addictive and that it was going
to harm her baby.
Senator Collins. Are your patients generally first-time
addicts or are they individuals who had problems with
addictions who have now switched to OxyContin?
Ms. Green. It depends on the age group. I have, for
example, just now she is 34 weeks pregnant and she is expecting
her ninth baby. She is 30 and she has gone through the gamut of
moving up from Tylox to Percoset, eventually ending up with
OxyContin. OxyContin is the best thing that ever happened to
her, as far as she is concerned.
Then I have younger women, 17, 18, 19, 20-year-olds, that
know OxyContin is the first choice and best choice, so they are
not even fooling around with anything else. They are going
straight for OxyContin.
Senator Collins. Now Washington County borders Canada. In
fact, I think your husband is a Canadian physician or at least
practices in St. Steven, right across the border from Calais.
Ms. Green. Right.
Senator Collins. Is that a factor in the availability of
OxyContin?
Ms. Green. I am so glad you brought that up. Unlike all the
other rural communities in the United States, unlike the rest
of the country, we are 50 yards away from Canada where
prescriptions, all prescriptions, not just opiate
prescriptions, are 50 percent cheaper than in the United
States. So our addicts are going to St. Steven to buy OxyContin
and Dilaudid and that is where your Dilaudid figures are coming
in.
If they cannot get OxyContin in Washington County they are
going to St. Steven and there is no question it is cheaper.
They have to pay $40 in Maine for a 40 milligram tablet. They
pay $20 Canadian, which is equivalent to $16 U.S. for the same
tablet.
Senator Collins. So that suggests, when we are looking for
solutions to this problem, that is one reason you mentioned in
your testimony we need an international approach.
Ms. Green. Yes, yes.
Senator Collins. Because just solving the problem through,
for example, if this were part of the solution, a prescription
monitoring program in Maine, that is not going to stem that
flow.
Ms. Green. It is not going to, absolutely not. And we are
having a dialogue with New Brunswick now. In fact, we met with
the governor of Maine just last week and we brought a
representative from New Brunswick who is the administrator of
the Charlotte County Hospital in New Brunswick who is trying to
start a group just like we have and, in fact, they are going to
join Neighbors Against Drug Abuse because New Brunswick at this
point is still about a year and a half behind us in denial.
``We do not have a problem. That is the one in the States. We
do not have a problem.'' So it is widely available.
Senator Collins. Thank you.
Dr. Goldenheim, how much does Purdue Pharma spend in
marketing and educational efforts on OxyContin since it was
first introduced in 1995?
Dr. Goldenheim. Senator, I do not have a total figure for
you. I can tell you that last year about 19 percent of sales
was spent on selling and promotional activities, which is a
fairly typical figure for our industry.
Senator Collins. Could you translate that into dollars for
me?
Dr. Goldenheim. Sales last year were a little over $1
billion, so it is probably a little over $200 million. That
would include the cost of the field force and other
representatives and the various materials that they distribute.
Senator Collins. You showed us a number of excellent
materials and I have been through them in your submitted packet
to the committee that are designed to alert people to the
dangers of abusing prescription drugs. They are excellent
materials. I am curious whether they were provided to
physicians by your field reps when you first began marketing
OxyContin or whether these were only developed later, when it
became evident that there was a serious problem with abuse of
your product.
Dr. Goldenheim. The answer is a little bit of both. Some of
the materials, for example the opiod therapy documentation kit
which talks about some of the issues that Dr. Payne raised
about assessment and proper documentation and evaluating the
patient and forming an individualized treatment plan, that and
some of the guidelines were distributed as soon as they were
available in 1997, some 3 years or so before I think any of us
were aware that there was a problem.
I should say that previously we had distributed other
guidelines from the AHCPR and the World Health Organization,
which were actually incorporated into our original package
insert. So we have disseminated these guidelines as they were
developed by the medical community.
Some of the other materials, to fully respond to your
question, for example the brochures on how to avoid abuse and
diversion, tamper-resistant prescription pads, those were
developed after we were alerted to the problem, typically in
cooperation with law enforcement. We spent a great deal of
time, the senior executives of Purdue, traveling up and down
the Northeast corridor, starting in Maine, trying to learn what
the problem was, what the sources were, and they have been
described very nicely and we developed those materials in
response to that.
Senator Collins. Doctor, I want to go back to the $200
million figure that you gave me earlier for the cost of your
marketing efforts last year for this drug, and you said it was
typical. Is it typical to spend that much for marketing on a
drug where there is no direct-to-consumer advertising?
Dr. Goldenheim. Yes, I think that is a fairly common figure
in our industry because it is an all-in figure and, as I said,
includes all the salaries of the field force, the
representatives. There are 800 of them. It includes all the
materials. It includes all the kinds of things that we are
talking about here today.
Senator Collins. Dr. Van Zee, did any of Purdue Pharma's
representatives market OxyContin to you?
Dr. Van Zee. It was late in the whole epidemic of things
before I was seen by Purdue reps. I am not sure that was the
case. It may have been our location, out of the way.
Senator Collins. Do you recall the nature of those
marketing activities? Was there a caution given to you? Since
you are an internist, you are not a pain specialist, I am
assuming; is that correct?
Dr. Van Zee. That is correct. I treat general internal
medicine patients. I treat cancer patients. I treat patients
with chronic intractable pain.
Senator Collins. And perhaps you do not recall but when
Purdue Pharma's representatives came to you did they come
bringing the pamphlets that we have seen today warning about
the potential for abuse of this product?
Dr. Van Zee. I honestly--it has been a long time and I
cannot recall. I know I was reminded that there were doctors in
California being sued for not treating patients appropriately
with opiods but I was not struck personally by the
inappropriateness of my individual Purdue sales rep, as I was
by the way that the company has marketed and promoted this in
general.
Senator Collins. I know my time has expired so let me just
finish with one question to you. What led you then to conclude
that the marketing of OxyContin was not appropriate?
Dr. Van Zee. Well, it is in the body of my statement but I
was surprised to find out, when we found this out a year or so
ago, that a pharmaceutical company would market a drug in such
a way, particularly a highly abusable drug, where they develop
physician profiles as to which physicians prescribe opiods most
liberally. But, as I say, to me, that is very transparent in
that it also tells you who prescribes least discriminately.
If you couple that with very lucrative financial--you give
that kind of data to your sales reps with a very lucrative
financial plan for them to increase their OxyContin sales in
their territories, to me, that is a recipe for commercial
success and public health problems.
Senator Collins. Thank you.
Thank you, Mr. Chairman.
Senator Reed. Thank you, Senator Collins.
Senator Dodd?
Senator Dodd. Thank you, Mr. Chairman.
It has been a great panel and I want to thank all of you. I
have great admiration, Dr. Van Zee, for someone who has
dedicated a good part of your career to work in an impoverished
area of the country. I admire that immensely and Mrs. Green, as
well, your work in--Washington County? I even like how you
pronounce Calais. You know, we have a place in Connecticut
called Versailles. We know how to pronounce those names in New
England, do we not?
I am sorry I missed your testimony, Mr. Bess. I read it--
Dr. Goldenheim, as well.
First of all, just as a matter of record, Mr. Chairman, it
may have already been stated here and again let me state it for
the record, one of my constituents is Purdue Pharma. I would
not necessarily, because you are a constituent, be saying
things in your favor for the sake of it. I know the company
very well and know the employees there well and I think you
have done a very good job testifying here about this and the
steps you have taken.
I will ask unanimous consent that this be a part of the
record but I want to just quote it. From day one, as I
understand, as part of the insert with OxyContin going out,
1995 on--you correct me if I am wrong--has said the following,
and I quote: ``Patients should be advised that OxyContin is a
potential drug of abuse. They should protect it from theft. It
should never be given to anyone other than the individual to
whom it is prescribed. OxyContin may be expected to have
addictive effects when used in conjunction with alcohol, other
opiods or elicit drugs which cause central nervous system
depression. As with all such drugs, care should be taken to
prevent diversion or abuse by proper handling.''
Has that been on the package? Am I correct that that has
been part of the insert from the very beginning?
Dr. Goldenheim. Yes, that is correct. In fact, when we
launched the product the original package insert had at the
time what I think was some of the most informed information
wording, explanations about abuse and diversion and addiction.
I think it is also important to remember, and I think Dr.
Jenkins alluded to this, that this has been sold as a Schedule
II narcotic since the day it went on the market. There is no
higher classification for a drug that can be legally
prescribed.
So, for example, just the obvious signal that that sends to
a physician is he or she knows that they cannot call a pharmacy
the way I could call a pharmacy for any other medicine, as long
as it is not a Schedule II. But for Schedule II I have to make
a conscious decision to write out the prescription. So that is
a very strong signal and, of course, that has always been
known.
Senator Dodd. Now let me ask you this. To what extent did
you consider at the company about going directly to consumer
marketing? I presume that was somewhat of a debate within the
company, whether or not to go that route, which would have been
legal, or to take the route that you took? And to what extent
were the abusive drug addictive elements of this thing a part
of that decision-making process, if any?
Dr. Goldenheim. To be honest, it was not a debate. It has
come up from time to time. Someone has said, gee, a lot of
pharmaceutical companies are doing direct-to-consumer
advertising; should we be doing it? And we have all immediately
said no, we do not think that that is the right thing to do.
So it has not been a debate. These are complicated drugs to
use. They do have abuse liability, which we have called out.
And for that reason, among others, I do not think these
medicines should be advertised directly to consumers.
Senator Dodd. Senator Collins raised the issue of the
different materials that you have sent out and you answered
that there were some that went out initially and then some in
response to the--what was it, approximately four or five years
after the product was available that the awareness of the
problems Ms. Green has seen with her patients and people she
works with and Dr. Van Zee has seen.
How quickly did you, to close the loop on Senator Collins's
question, you became aware of this as a problem with OxyContin
when?
Dr. Goldenheim. As Senator Collins has alluded to, around
March of 2000. I think even before the report in the Bangor
paper, which I think you said was April of 2000, we had a copy
of a letter that the then-U.S. Attorney Jay McCloskey, who is
now a consultant for Purdue--he is no longer the U.S. Attorney,
and he is here today if you have any more detailed questions
about our activities in Maine--he wrote a letter to physicians
because he became alerted to this problem, was concerned about
this problem. I think the letter is dated February of 2000. I
think we got it in March of 2000 and as soon as we got it we
had one of our senior physicians call him and engage in a
dialogue.
I think it took him a few months before he was comfortable
talking to us. He was a little uncomfortable with talking to
the manufacturer of the product that appeared to be associated
with some problems. He actually sent some of his agents and a
DEA agent to a medical education event that we were sponsoring
and his people came back and were quite impressed with the
detailed information about prescribing that was given and that
it was generic, it was not branded, and that led to a meeting.
That was around September of 2000 and at that point we
began to hear more and more reports and we traveled everywhere.
We initiated meetings with Attorneys General, with U.S.
Attorneys, FDA, DEA, to try to learn as much as we could about
this and many, if not most of the ideas for these programs came
as a result of that interaction with law enforcement, local
community leaders, and health care professionals.
As one person said, one law enforcement official said, when
we learned of the problem we jumped in with both feet.
Senator Dodd. How quickly were these materials then
produced?
Dr. Goldenheim. Some within months of knowing about the
problem. Another thing we did which goes back to March of last
year was we developed a model based on the communities where we
were hearing reports. We developed a model to try to predict
where we might get other reports because we wanted to try to
get ahead of the problem and the model, I think, was good and
helpful and predicted about 100 counties. It included the
counties, at that point six where we had heard of significant
problems.
We called our field force in. I think it was about 180
representatives that cover those counties, gave them additional
3 days of intensive training. DEA participated in that training
and we told them to go back out and call on physicians and
emphasize only proper prescribing and how to avoid abuse and
diversion and made it clear to those physicians that if they
were not going to prescribe according to the proper guidelines
of documentation and assessment and all of the important tools
to avoid in abuse and diversion that we did not want them to
write for our product.
Senator Dodd. Let me just ask one more question if I can,
Mr. Chairman. That is to Dr. Van Zee.
We had written testimony submitted to us by a Dr. Russell
Portenoy. You are all familiar with him, I presume. Apparently
he is a foremost expert, I am told, on pain management from
Beth Israel Medical Center and he argues, and I am quoting now
from his testimony, he says that ``Any extreme response to
OxyContin abuse, such as eliminating prescribing by
nonspecialists or removing the drug from retail pharmacies,
would do more than directly damage the large number of patients
now benefiting from OxyContin,'' and we have heard testimony
about that from the different responses.
He goes on to say, ``It would have a chilling effect on
prescribing overall. The overall result would be more
undertreatment.''
How do you respond to that? I mean you have heard this
before and I hear what you are saying and what Ms. Green is
saying, as well. Are you arguing, Ms. Green, by the way, that
OxyContin ought to be taken off the market? Do you agree with
Dr. Van Zee or you are somewhere less than that or take it off
the shelves?
Ms. Green. If OxyContin remains the way it is now it should
go off the market. If OxyContin is going to change its formula,
add naltrexone to it, definitely it needs to stay. If they
lower the dose, it needs to stay. If they lower the production
of it, it should definitely stay. It definitely has a place in
pain management and it should be available for hospice
absolutely, oncology centers, cancer patients, and those that
know how to treat chronic pain.
Senator Dodd. Dr. Van Zee, how do you respond to Dr.
Portenoy's point here? We all know about this. Everyone can
cite a family member. I remember calling in the middle of the
night with my closest boyhood friend all through school who
died a few years ago of cancer and literally calling, sitting
with him in the middle of the night calling his physician,
waking him up because he was just in so much pain before he
died. And just the battle I had to go through to get those--now
he was dying. The only thing to do was to try to manage his
pain so that his remaining hours would not be in agony and what
a battle it was. And I am not alone. I have heard legions of
these stories.
So I am not unmindful of the other side of the equation but
boy, it is a serious, serious problem and this reluctance on
the part of the medical community, this exaggerated fear of
addiction. Is that a problem here?
Dr. Van Zee. If I could be a little circuitous in getting
back to that, I would just say in response to some of these
things, I think if we all left out of the room today we would
be left with the impression that this is a problem in central
Appalachia and in Maine and my contention is that it has become
a national problem. I do not think the full picture has been
mentioned today.
The president's Office of National Drug Control Policy in
November 2000 pulled out their Pulse Check Report and they
mentioned that OxyContin abuse has emerged as a significant
problem in Baltimore, Boston, Denver, Detroit, New Orleans,
Philadelphia, St. Louis, Washington, DC., Billings, Montana,
Honolulu now.
So what we could see as a problem 15 months ago as Maine
and Southwest Virginia is extended way beyond that in
Pennsylvania, two methadone treatment centers in Southwest
Virginia, 90 percent of all their admissions were involved.
Louisiana, Arizona, South Carolina, Alabama all report high
incidence of people entering methadone programs as being
dependent on this.
Getting back to Dr. Portenoy, there are a couple of issues
that need to be separated out. What is the role of opiods for
people who have cancer and terminal diseases, like your friend
that you lost? I think it is very clear that pain for those
people has been poorly treated through the years and I think
there has been a good and significant change about increasing
awareness about how much better we have to be about that.
I think there is no issue about using opiods in cancer pain
or any severe terminal illness. I mean you use whatever dose of
opiods one can use in whatever combination to make things as
comfortable and merciful as it can. The real issue in the whole
thing is what is the role of opiods in chronic, noncancer pain,
chronic, nonmalignant pain? And the truth of that is that there
are many things that we do not know about that.
I talked to Dr. Portenoy in a personal conversation a
couple of weeks ago at the FDA meeting on opiods and he--as
with any therapy, you have to evaluate what the risks are, what
the benefits are of a certain type of therapy, what the risks
are, and always carry with you the admonition that we, as
physicians, should do no harm. So you need to have good
information. What are the true benefits? What are the risks in
treating this population of chronic nonmalignant pain?
Dr. Portenoy in his lecture said to the whole FDA meeting,
we really do not know what the risks are of addiction
developing from treating people with chronic nonmalignant pain
and that is a fair summary of the state of our knowledge about
that. We do not know.
Now if the rate of addiction disorders in general in the
population can be 5 to 12 percent, a lot of people say 7, 8, 9
percent, you know, if the risk of opiod addiction in treating
your patients and they take it exactly as you prescribe it is
much less than 1 percent, that is one issue. If it is 5 percent
and you have a million people on OxyContin, that means you have
iatrogenically addicted 50,000 people and not only destroyed
their lives but much of their family.
Now nobody knows what those figures are but to me, what I
have seen as a tremendous push in the pain management community
to use opiods very liberally in chronic nonmalignant pain has
also been fueled by the industry with a lot of commercial
enthusiasm and I think over the next decade we will find out
that there has been a lot of unfortunate errors made about how
much we have done with how little knowledge we have had to do
it.
Senator Dodd. Dr. Payne, do you want to comment on this?
Dr. Payne. I just want to say that chronic pain is a public
health problem. It is a crisis. I mean the Congress declared
this the decade of pain research. The American Pain Society,
the American Pain Foundation have all declared this as a public
health crisis.
I think just for the reasons that you mentioned, Senator
Dodd, we have to strike a balance. I think the balance comes in
prescription monitoring programs, in better education, and I
personally react adversely to profiling issues, so I do not
know if we want to go there but clearly there should be areas
where the medical societies can review physician prescribing
practices, as opposed to at least initial review being law
enforcement. I think therein we can strike a balance to protect
society on the one hand but to provide people with treatment
that they need. Chronic pain is a public health crisis.
Senator Dodd. Can I ask one more question?
Senator Reed. Yes, Senator, you may.
Senator Dodd. Dr. Van Zee, you raise the issue. I would
like to know where is the evidence? I am not suggesting that
there is not some but it just strikes me that the link between
a manufacturer's marketing techniques and illicit use or
inappropriate prescribing, you mentioned in your testimony and
I quote here, ``Conventional wisdom says that if a drug is
widely available, it will be widely abused.'' Is there more to
this than that?
Dr. Van Zee. I think that is an old adage.
Senator Dodd. Another one of those Appalachian things?
Dr. Van Zee. No, it goes way beyond. It is a national
adage.
Senator Dodd. I am only kidding.
Dr. Van Zee. That if you have a drug that can be abused, it
will be abused. Then I would say by extension if you have an
abusable drug that is widely available, it will be widely
abused.
In Southwest Virginia the DEA has very nice figures
compiled on OxyContin consumption in the United States and if
by and large you look at that map of OxyContin consumption in
the United States, the states that have the most consumption--
--
Senator Dodd. But we are talking about illicit use here.
How do you address illicit use by going after targeting and
promotion of a product that is supposed to be used legally? I
do not understand the connection between illegal use and
marketing and promotion. I do not see the connection.
Dr. Van Zee. The connection is that in Southwest Virginia
in the 14 counties affected by it, OxyContin was prescribed 600
to 800 percent higher than Virginia and the rest of the country
in general. If you have that kind of availability of a drug,
you do have a lot of recreational drug use. You have, like we
had, 9 percent of our seventh graders having used OxyContin; 25
percent of our 11th graders having used OxyContin.
Senator Dodd. That is a serious issue but we are kind of
missing each other. We are passing in the night here. I am not
sure we are talking to each other.
Dr. Van Zee. Let me try to make the connection. If you know
that the area of your country that is having the problems with
OxyContin abuse----
Senator Dodd. They have a problem with drug addiction. You
have a problem of kids who are--it is an OxyContin problem in
the sense that they are using that product but there is
something far more profound going on here than just the
availability through legal channels of a painkiller.
Dr. Van Zee. Obviously we do not have all the information
here but if you have an area of the country, and perhaps that
is our area, that are high prescribers of controlled
prescription drugs or opiods and you have a pharmaceutical
company that finds out which physicians are most liberal
prescribers of opiods and if you couple that with the sales
representative force that has lucrative incentives to increase
the OxyContin sales or whatever other drug is involved in their
territory, I think it is a recipe for commercial success and
public health problems.
Senator Dodd. I thank you. You have been very patient. I
apologize to both my colleagues.
Senator Reed. Thank you, Senator Dodd.
Let me recognize Senator Collins for some brief comments
and then I will close the hearing.
Senator Collins. Thank you very much, Mr. Chairman.
I first want to start by thanking you for calling this
hearing and presiding over it. I think it was extremely
informative and that all of our witnesses helped us gain a
better understanding of this problem.
To Dr. Payne, since I did not get a chance to question you,
I want to thank you for the work that you are doing every day
in helping people with chronic pain.
And to Mr. Bess, whom I also did not get a chance to
question, thank you for your service on the law enforcement
side of this problem.
But in particular I want to thank my constituent Nancy
Green for coming down and sharing her first-hand perspective.
She came all the way from Calais, ME and for those of you who
do not know where that is, that is in far eastern Maine on the
Canadian border. She had to drive two hours to even get to the
airport in Bangor and you will probably not be surprised to
hear that you cannot take a direct flight from Bangor to
Washington.
Senator Dodd. It is shocking to hear that.
Senator Collins. So it was a long journey but one well
worthwhile because we learned----
Ms. Green. Just thank my mothers they did not go into labor
while I am here.
Senator Collins. We very much benefited from your testimony
and I think that you have given us a lot to think about and I
very much admire your community activism, as well as your
providing of health care to the people of a very rural part of
Maine. So thank you very much and thank you, Mr. Chairman.
Senator Reed. Thank you, Senator Collins.
I want to also thank the witnesses for their testimony. We
have illuminated a very complex issue here, which involves
medical practice, the sale of pharmaceuticals, the issues of
pain, the issues of law enforcement, a whole host of
complicated and interrelated issues that I suspect we will
continue to think about and worry about going forward.
We have a situation where we have to ensure that there is
access to palliatives because, as Dr. Payne pointed out, there
is a public health crisis in the recognition and treatment of
pain. However, we certainly have to stop and wonder what we can
do if 9 percent of the seventh graders, as Dr. Van Zee pointed
out, and 25 percent of high school students are experimenting
with OxyContin. We really have a mutual responsibility, not
just the Senate, not just the medical profession, not just the
manufacturer and not just law enforcement, but all of us. We
have to do better and I hope this hearing will allow us in some
way to think harder and do better.
I would like to again thank the witnesses. The committee
record will be open for 14 days to allow others who wish to
submit written statements to do so and also allow colleagues on
the committee to follow up with written questions to our
witnesses. Senator Dodd made several requests to include
documents. Those requests will be agreed to by unanimous
consent.
[The prepared statement of Senator Jeffords follows:]
Prepared Statement of Senator Jeffords
I am pleased that the full Committee is having this hearing
today to discuss the issues surrounding the pain relief drug,
Oxycontin. Reviewing news reports and the testimony to be
offered today, Oxycontin appears to either hold great promise
for relief of those in pain, or great risk from its misuse. It
is essential that Congress be aware of the issues surrounding
this drug and this hearing is an important step in that
process.
Oxycontin is a synthetic form of morphine used to treat
severe pain--primarily in cancer patients. But a growing number
of people in Vermont and the entire United States are abusing
this prescription drug. For example, in my home state of
Vermont heroin addicts have been grinding up Oxycontin and
either snorting or injecting it to produce a high similar to
that produced by heroin.
People have been obtaining Oxycontin through a variety of
means, theft, false prescriptions, and even in some cases
buying it from people that legitimately need the drug. Many
users are willing to pay about a dollar a milligram which adds
up to 80 dollars a pill.
The risks associated with this drug have lead some
pharmacies in my state to refuse to carry Oxycontin or install
expensive security systems to try and prevent its theft. In
addition, concerns over the dangers of Oxycontin has led
Governor Howard Dean to decide that Vermont's general
assistance program will no longer cover the costs for these
prescriptions.
While there are clearly risks associated with Oxycontin,
its ability to provide relief to people suffering from severe
pain is unquestioned. In a hearing on pain management I held in
this committee in 1999, it became clear that far too many
patients suffer needlessly and that more must be done to ensure
that adequate pain relief is readily available to the tens-of-
thousands of patients for whom severe and intractable pain is
part of their daily lives.
This hearing will provide us with some important
information on whether Oxycontin will fulfill its great promise
for relief of those in pain, or continue to be known for its
great risk of misuse. I look forward to the testimony of these
witnesses, and once again thank the Chairman for holding this
important informational hearing.
Senator Reed. I now will thank you all and this hearing is
adjourned.
[Additional material follows.]
ADDITIONAL MATERIALS
Statement of the American Pharmaceutical Association
Mr. Chairman and Members of the Committee, the American
Pharmaceutical Association (APhA) welcomes the opportunity to present
the pharmacist's perspective on the use of OxyContin. APhA
and its members are committed to working with Congress, the Food and
Drug Administration (FDA), the Drug Enforcement Administration (DEA),
health care providers, and patients to find the appropriate balance
between effective pain management and measures to curb the abuse and
diversion of prescription drugs.
APhA, the national professional society of pharmacists, is the
first established and largest professional association of pharmacists
in the United States. APhA's more than 50,000 members include
practicing pharmacists, pharmaceutical scientists, pharmacy students,
pharmacy technicians, and others interested in advancing the
profession. The Association is a leader in providing professional
information and education for pharmacists and an advocate for improved
health through the provision of comprehensive pharmaceutical care.
THE PHARMACIST'S ROLE IN PAIN MANAGEMENT
Opiate analgesics like OxyContin are a valuable tool in
the management of pain. Opiate analgesics have significant therapeutic
value for the millions of patients who suffer from chronic pain due to
disease, injury, or surgery--pain that other medications will not
alleviate. However, pharmacists also recognize the potential for abuse
with opiate analgesics, or any controlled substance, and are very
concerned with the inappropriate use of any prescription drug product.
Prescription medications are safe and effective when used
appropriately, but they can be deadly when used incorrectly.
Pharmacists are the health care providers who work most closely with
patients to make the best use of medications. Prescription drug abuse
is one type of medication misuse. Pharmacists work collaboratively with
prescribers and other health care providers to prevent the diversion of
prescription medications and to identify incidents of abuse or
addiction. As part of this process, pharmacists assess the
appropriateness of every prescription order they review or dispense.
Pharmacists watch for individuals who attempt to fill fraudulent
prescriptions, visit multiple prescribers, or present prescriptions for
unusually large quantities of medication. However, it is not always
easy to determine if a prescription is legitimate--no simple algorithm
determines appropriate use. And importantly, pharmacists cannot view
every patient as a potential drug abuser without compromising their
responsibilities as a health care provider.
EDUCATION--NOT RESTRICTED DISTRIBUTION--IS THE ANSWER
APhA strongly supports the FDA's and the DEA's efforts to ensure
that legitimate users of opiate analgesics like OxyContin
maintain the ability to continue using these products, while reducing
their diversion and abuse. Although APhA agrees that some action is
necessary to address the diversion and abuse of opiate analgesics, we
caution, however, against efforts to restrict the distribution of
opiate analgesics or arbitrarily limit health care providers' ability
to prescribe or dispense appropriate pain relief medications. With
every barrier erected to limit diversion, the potential for those
barriers to diminish appropriate prescribing increases exponentially.
Restrictions in the drug distribution process can disrupt patient care
by delaying access to medication therapy, disrupt existing patient-
pharmacist-prescriber relationships, and potentially create an increase
in the cost of medications. Also, any additional stigma attached to the
drugs will have a significant chilling effect on health care providers'
willingness to prescribe and dispense the appropriate pain medication
and patients' interest in using the medications. Decreasing the number
of patients using a medication may be seen as a ``success'' in managing
risk. But this ``success'' is tempered by the accompanying ``failure''
of patients with legitimate need to access the same medication.
APhA believes that measures to curb abuse and addiction should be
considered but discourages using any administrative barriers like
triplicate prescriptions as a risk management solution.
In 1982, the state of Texas implemented a triplicate prescription
law for controlled substances. A subsequent study of a 1200-bed
teaching hospital found a 60% decrease in prescriptions for Schedule II
controlled substances from 1981 to 1982.\1\ This shows that simply
increasing recordkeeping requirements will discourage use of these
medications. It is highly unlikely that 60% of these prescriptions were
unnecessary. And in a survey conducted by New York State's Public
Health Council, 71% of physicians surveyed reported that they do not
prescribe the most effective pain medication for cancer patients if the
prescriptions require a special state-monitored prescription form for
controlled substances--even when the medication is legal and medically
indicated for a patient.\2\
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\1\ Sigler K, Guernsey B, et al. Effect of a Triplicate
Prescription Law on Prescribing of Schedule II Drugs. American Journal
of Hospital Pharmacy 41 (1984), 108-111.
\2\ New York State Public Health Council, Report to the
Commissioner of Health, Breaking Down the Barriers to Effective Pain
Management: Recommendations to Improve the Assessment and Treatment of
Pain in New York State, January 1984.
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We do not believe that measures to curb abuse and addiction should
be avoided, however, measures that simply increase providers' paperwork
or restrict access to one troublesome product will not solve the
problem. Those suffering from chemical dependency will find another way
to obtain the product or find another product to achieve the same
effect. These individuals need help to treat their substance abuse and
addiction.
During a December 2001 U.S. House of Representatives
Appropriations' Commerce, Justice, State, and Judiciary Subcommittee
hearing on OxyContin, both DEA Administrator Asa Hutchinson
and Subcommittee Chairman Frank Wolf stated that they do not want or
intend to restrict legitimate use of the drug. According to Hutchinson,
the ``DEA recognizes that the best means of preventing the diversion of
controlled substances, including OxyContin and all other
drugs, is to increase awareness of the proper use and potential dangers
of the products.'' The Association agrees, and notes that pharmacists
can be an excellent communicator of that information.
APhA fully supports efforts to examine possible strategies to
reduce the abuse and diversion of opiate analgesics without restricting
access to drugs for patients with legitimate medical need. Last
October, APhA in collaboration with 20 other health care organizations
and the DEA, released a joint consensus statement on the need to
prevent abuse of prescription medications while ensuring that they
remain available for patients in need. The groups recognized that for
many patients, opiate analgesics are the only treatment option to
provide effective and significant pain relief. However, a narrow focus
on the abuse potential of a drug could erroneously lead to the
conclusion that these medications should be avoided when medically
indicated--generating a sense of fear rather than respect for their
legitimate purpose.\3\
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\3\ A Joint Statement From 21 Health Organizations and the Drug
Enforcement Administration. ``Promoting Pain Relief and Preventing
Abuse of Pain Medications: A Critical Balancing Act.'' Oct. 2001.
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APhA understands that one strategy to reduce the abuse and
diversion of OxyContin has already been initiated by the
drug's manufacturer--Purdue Pharma. In August 2001, Purdue Pharma
announced plans to reformulate OxyContin to reduce the
potential for abuse. The addition of naloxone to OxyContin
would prevent abusers who crush and inject the drug from obtaining the
desired ``high.'' APhA supports Purdue Pharma's efforts to reduce the
potential for abuse of its product and we encourage Congress and the
FDA to work with the manufacturer to accelerate the development and
approval of the reformulated version. A reformulated version will
continue to provide patients with effective pain management, while
removing the stimulus for illegal abuse, and importantly for
pharmacists, lessening the potential for pharmacy robberies related to
OxyContin abuse.
It is important that patients do not lose access to a valuable and
effective pain medication because of a failure to prevent medication
misuse. Restricted distribution is not the answer. The solution
requires the education of health care professionals, law enforcement
personnel, and the public on the use and abuse of pain medications.
Thank you for your consideration of the views of the nation's
pharmacists.
Prepared Statement of Charlene Cowley
Mr. Chairman and Members of the Committee: The American Society of
Pain Management Nurses (ASPMN) is an organization of professional
nurses dedicated to promoting and providing optimal care of patients
with pain, including the management of its sequelae. The organization
feels strongly about advocating for appropriate care and against the
many barriers that may affect care to patients with pain.
Currently, pain is ``untreated, under treated or ineffectively
treated for over 75 million Americans each year'' (American Pain
Foundation, 2000). A silent epidemic of pain and suffering is occurring
in our nation. As nurses, we witness this tragedy every day and we are
ethically bound to advocate for our patients. Opioids, including
OxyContin are one of many options that may be necessary for
appropriate pain relief. Though there is a concern about misuse and
diversion of these medications as a significant public health problem,
there is another and even greater public health issue--the
undertreatment of pain.
ASPMN would like to address the issue concerning the use of and
access to opioids for patients who suffer with pain whether related to
chronic conditions or life-threatening illness. Opioids are appropriate
for chronic pain conditions and ``an essential part of the pain
management plan,'' as cited by the consensus statement from the
American Academy of Pain Medicine and the American Pain Society (1997)
as well as supported by the AHCPR Pain Guidelines (1992; 1994).
As one of the over 20 healthcare organizations, ASPMN supported the
joint statement released in collaboration with the Drug Enforcement
Administration in October 2001 (see attached). Overall, we support the
call for balance and agree with the DEA Administrator Asa Hutchinson
that there is no further need for legislative remedies to curb the
illegal diversion of controlled substances. Yet there is a need to
protect and improve access to all the treatment options to manage pain
effectively.
ASPMN believes that people diagnosed with the disease of addiction
should receive appropriate medical care. However, legitimate patients
with pain should not be denied treatment because of the destructive
behaviors surrounding addiction or, even worse, the activities of
criminals. ASPMN would strongly oppose legislation that would increase
barriers to legitimate patients obtaining needed appropriate
medications. In 2000, Congress proclaimed this the Decade of Pain
Control and Research. ASPMN supports legislation that:
Provides for a National Report on the Problem of Pain
Improves Pain Management Education for Healthcare
Professional, Caregivers and the Public
Reduces regulatory barriers that inhibit effective Pain
Management
Increases Federal Support for Pain Research
Expands reimbursement for Pain Management Services
Requires Pain Assessment and Treatment of Unrelieved Pain
in all healthcare settings
Thank you for your thoughtful consideration of these issues. ASPMN
offers its support and willingness to be available for collaboration to
facilitate a balanced approach regarding OxyContin.
Statement of the National Association of Chain Drug Stores
reducing the incidence of armed robberies involving oxycontin in
community pharmacies
Mr. Chairman and Members of the Committee, NACDS appreciates the
opportunity to submit this statement for the record regarding the abuse
of OxyContin and measures to curb diversion and reduce the number of
armed robberies in community pharmacies.
NACDS represents nearly 190 chain pharmacy companies that operate
about 34,000 retail pharmacies all across the United States. Chain
pharmacy is the single largest segment of pharmacy practice. We filled
about 70 percent of the 3 billion prescriptions provided across the
nation last year.
OXYCONTIN ROBBERIES ON THE RISE
Our members' pharmacies have been targeted by OxyContin abusers for
armed robberies. We are concerned for the safety of our pharmacists,
technicians, clerks, cashiers, and our customers. Some pharmacies have
even contemplated not carrying the product. We support an all-out
effort on the part of the manufacturer to reformulate the product to
produce one that is equally effective for legitimate patients with
chronic pain but, at the same time, resistant to potential diversion
and abuse of the drug. Any pressure that can be exerted on the
manufacturer, the Food and Drug Administration (FDA) and the Drug
Enforcement Administration (DEA) to expedite the development of such a
product will be instrumental in eliminating this public health crisis.
OXYCONTIN IS A SAFE AND EFFECTIVE DRUG WHEN USED AS PRESCRIBED
OxyContin is an opioid analgesic used to treat pain. Each tablet of
OxyContin delivers to the patient, over a period of twelve hours, a
controlled release dose of oxycodone. OxyContin is a Schedule II drug
with recognized abuse potential. Introduced by Purdue Pharma in 1995,
OxyContin is used to treat chronic moderate to severe pain when a
continuous, around-the-clock analgesic is needed for an extended period
of time. The benefit to patients who suffer with chronic pain is that
medication is limited to two doses per day rather than four to six
times per day.
OxyContin prescriptions have increased twenty fold since 1996 to
approximately 6 million prescriptions in 2000. There is no doubt that
OxyContin is safe when taken as prescribed and effective for treating
chronic pain.
DIVERSION AND ABUSE OF OXYCONTIN
However, diversion and abuse of OxyContin is also on the rise.
Diversion of OxyContin began in rural areas of Maine, Kentucky, and
West Virginia and is now spreading into urban areas. To date, at least
fourteen states have experienced increases in abuse and diversion of
OxyContin. The controlled release formulation is easily compromised.
Abusers crush the tablet and then swallow, snort or inject a solution
to experience large amounts of oxycodone that give them a ``high''.
DEA's Office of Diversion Control reported 700 OxyContin thefts in
the U.S. between January 2000 and June 2001. Florida reported 82 thefts
compared to 90 in Pennsylvania, 69 in Kentucky, 74 in Ohio and 34 in
California. Massachusetts has had over 60 robberies since January
alone. Pharmacists are increasingly fearful of becoming the next target
for an OxyContin robbery.
Deaths and overdoses have also been reported. Usually, these
reports are the result of the abuse of opiates or a combination of
drugs and alcohol. (Twenty U.S. metropolitan areas reported that
oxycodone related deaths have increased 400% and emergency room visits
have increased 100%.) Drug treatment programs in the most affected
states (WV, PA, KY, and VA) report that 50-90% of newly admitted
patients identified OxyContin as their primary drug of abuse.
DEA ACTION PLAN
DEA has implemented an action plan that NACDS fully supports. The
plan includes investigation of unscrupulous and/or unethical medical
professionals, forged and fraudulent prescriptions, pharmacy theft, and
doctor shopping. DEA also has focused on gathering data to better
define the scope of the problem. Information on prescriptions, deaths,
emergency room visits, thefts, and drug treatment program admissions is
targeted as well as investigations, arrests, and administrative
actions.
POTENTIAL SOLUTIONS TO OXYCONTIN DIVERSION
NACDS has explored numerous potential solutions to OxyContin abuse
and, in particular, as it impacts the increasing incidence of armed
robberies in community pharmacies. We have commissioned a study to be
conducted on the best practices for pharmacies. Recommendations will be
given on practices that will reduce safety risks to employees and
customers. Benchmarking current efforts by pharmacies, other retailers
and banks as well as advice from law enforcement agencies will be used
as the basis for the recommendations. The study will be presented at
the NACDS Fall Conference scheduled for October 28-31, 2001 in San
Antonio, Texas.
Reformulation of the product, in our estimation, is the number-one
priority for stemming this serious public health problem. On August 8,
2001, the company announced the development of a reformulated version
of OxyContin. The addition of naloxone, a narcotic antagonist, would
deter intravenous abusers. (Naloxone was added to Talwin for the same
reason several years ago and the product, Talwin NX, is no longer a
commonly abused product.) Purdue Pharma has also mentioned the
potential of developing a ``smart pill'' that would destroy oxycodone
when crushed.
TIME IS OF ESSENCE
However, Purdue Pharma estimates this new formulation could take as
many as three years to market. This timeframe is unacceptable. We urge
the FDA and the manufacturer to expedite the approval, production and
marketing of a reformulated version of OxyContin to make the new
product available to the public as soon as possible. At the same time,
all of the existing OxyContin should be phased out and recalled if
necessary.
This reformulation would achieve the balance that we are all hoping
to accomplish--keeping the product on the market for legitimate
patients suffering with chronic pain and reducing the potential for
abuse and diversion. Armed robberies that threaten our pharmacists, our
customers and our stores would also decrease as a direct result. We
thank you for the opportunity to comment on this serious public health
issue.
Statement of the National Institute on Drug Abuse
Mr. Chairman and Members of the Committee, I am pleased to submit
the following statement for the record discussing what we have come to
learn about psychoactive prescription drugs, their potential for abuse,
and how we can both prevent and treat individuals who may abuse or
become addicted to them. Because the specific topic of today's hearing
is OxyContin, I will provide some information about this opiate and
then broaden the discussion to give you an idea of how research on a
specific drug like this fits into the National Institute on Drug
Abuse's (NIDA's) overall research portfolio.
OxyContin as a prescribed medication is a very effective and
efficient analgesic. When used for legitimate medical purposes, this
controlled substance can improve the quality of life for millions of
Americans with debilitating diseases and conditions. It is often
prescribed for cancer patients or those with chronic, long-lasting
pain. It is when a medication such as this is intentionally misused
that it begins to pose a serious public health threat. This is what
appears to be happening with this particular drug.
OxyContin is the brand name for an opioid analgesic that is
prescribed by doctors for chronic moderate to severe pain. It was
approved by the Food and Drug Administration in late 1995. Because it
has the ability to slowly release its active ingredient oxycodone over
about a twelve-hour period, it is an effective and efficient medication
for the millions of people who suffer from chronic pain each year.
OxyContin tablets are produced and manufactured by Purdue Pharma in
various strengths ranging from 10mg to 160mg and are specifically
developed to be taken orally. It is classified as a Schedule II drug,
meaning it has a high potential for abuse and is only available by
prescription by a licensed physician.
This Committee has recognized what we also perceive as an important
emerging public health problem and why we launched last year a major
initiative on prescription drug abuse and misuse. NIDA is encouraging
more research in this area, particularly to understand the factors
contributing to prescription drug abuse, and to develop more effective
prevention and service delivery approaches as well as more behavioral
and pharmacological treatments.
A variety of sources, including NIDA's own Community Epidemiology
Work Group, a network of epidemiologists and researchers from 21 major
U.S. metropolitan areas who monitor and report on community-level
trends in drug abuse, are finding that people are ``short circuiting''
the time-release form of this medication by chewing, crushing, or
dissolving the pills. Chewing or crushing the prescription drug
corrupts or foils its time-release protection, enabling the users to
experience a rapid and intense euphoria that does not occur when taken
as designed and prescribed. Once having crushed the pills, the
individuals are injecting, inhaling, or taking them orally, often with
other pills, marijuana, or alcohol.
It is the active ingredient oxycodone, a synthetic opiate similar
to morphine, that appears to be particularly attractive to the user and
what is being used increasingly in urban, suburban, and rural areas.
For example, according to the Substance Abuse and Mental Health
Services Administration's (SAMHSA) Drug Abuse Warning Network,
emergency room mentions of prescription drugs containing oxycodone
(which may include drugs such as Percodan, Percocet, and OxyContin)
increased 89 percent from 1993 to 1999 (from 3,395 to 6,429). Recently
we have seen it increase by 68%, with 10,825 emergency room mentions in
2000.
It is this euphoric effect and the fact that many people perceive
prescription pain killers as ``safe'' that are likely the reasons why
this drug is being abused in such alarming numbers. The users want to
receive the pleasurable effects, in the same way that people abuse and
become addicted to drugs such as heroin or cocaine. In fact, there are
some indicators suggesting that this drug may be used by some as a
substitute for heroin.
Alternatively, some people may begin to use them appropriately as
prescribed but over time may deviate from the prescribed regimen and
may become addicted without intentionally setting out to abuse the drug
in the first place. Reports of people becoming addicted to OxyContin,
if used as prescribed, are rare.
Opioid drugs, such as oxycodone, work primarily through their
interaction with the mu opioid receptors, especially in the brain and
spinal cord. When activated, these receptors mediate the drugs'
analgesic effects. However, they also mediate the ability to produce
the euphoric state. Moreover, opioids like oxycodone have similarities
to virtually every other drug of abuse, including nicotine, alcohol,
marijuana, cocaine, heroin, and methamphetamine, in that they elevate
levels of the neurotransmitter dopamine in the brain pathways that
control the experience of pleasure.
Prolonged use of these drugs eventually changes the brain in
fundamental and long-lasting ways, explaining why people cannot just
quit on their own, and why treatment is essential. In effect, drugs of
abuse take over the brain's normal pleasure and motivational systems,
moving drug use to the highest priority in the individual's
motivational hierarchy, thereby overriding all other motivations and
drives. These brain changes, then, are responsible for the compulsion
to seek and use drugs that we have come to define as addiction. This is
likely the state people are in when they are reportedly ``doctor
shopping,'' feigning illnesses, and stealing from pharmacies to obtain
the drug.
Fortunately, we have a number of effective options to treat
addiction to prescription opioids and to help manage the sometime
severe withdrawal syndrome that accompanies sudden cessation of drug
use. These options are drawn from experience and clinical research
regarding the treatment of heroin addiction. They include medications,
such as methadone and LAAM (levo-alpha-acetyl-methadol), and behavioral
counseling approaches.
Typically, the patient is medically detoxified before any treatment
approach is begun. Although detoxification in itself is not a treatment
for opioid addiction, it can help relieve withdrawal symptoms while the
patient adjusts to being drug free. Once the patient completes
detoxification, the treatment provider must then work with the patient
to determine which course of treatment would best suit the needs of the
patient.
Medications that were developed through NIDA-supported research,
such as methadone and LAAM, can be used as effective treatments for
addiction to opiates, if available to the patient. Methadone is a
synthetic opioid that alters the effects of heroin and other opioids,
eliminates withdrawal symptoms, and relieves drug craving. Treatment
with methadone requires daily dosing. It has been used successfully for
more than 30 years and has allowed many addicts to lead productive
lives.
LAAM can alter the effects of opiates for up to three days.
Research has demonstrated that, when methadone or LAAM are given
appropriately, they have the ability to counter the euphoria caused by
the opiate, if the individual does in fact try to take the drug.
Researchers have also developed naltrexone, an opioid blocker that is
often employed for highly motivated individuals in treatment programs
that promote complete abstinence. Another medication, Naloxone
counteracts the effects of opioids and is used mostly to treat
overdoses.
As good as these treatments may be, there is no silver bullet for
treating addiction to opiates. Research has shown, however that
combining pharmacological approaches with behavioral therapies is the
most successful approach to treating drug addiction. Behavioral
therapies such as contingency management and cognitive-behavioral
interventions, for example, have both been found to complement anti-
addiction medications, such as methadone, successfully.
Unfortunately, many of the OxyContin abusers we are talking about
today may be in locations where methadone clinics that can dispense
medications are not easily accessible. This is one of the reasons we
are trying to bring new, safe, and effective medications to the offices
of physicians. NIDA is working with the Food and Drug Administration
and the pharmaceutical industry on a new medication called
buprenorphine. This medication has the potential for administration in
less traditional drug-treatment environments, thus expanding treatment
to populations who either do not have access to methadone programs or
are unsuited to them, such as adolescents.
The point I would like to conclude with is that although the
relatively sudden increase in drugs such as OxyContin and 3,4-
methylenedioxymethamphetamine (MDMA) may be among our greatest concerns
at this moment, they are just two of the many drugs out there that can
harm the citizens of our Nation. The overall picture of drug abuse in
the United States is constantly changing. As soon as we get a clear
understanding of drug use patterns and gain some control over existing
drug problems, new dangerous substances seem to emerge. Similar to the
way a virus mutates, both regional and national drug abuse patterns are
constantly reshaping and rarely remain static. By having our finger on
the pulse of these constantly changing drug trends and by having a
comprehensive research portfolio that covers all substances of abuse,
NIDA is poised to use the power of scientific research and its
application to avert emerging drug problems before they become national
epidemics.
Prepared Statement of Carlos Ortiz On Behalf of CVS Pharmacy
The following is an offer of information for the Committee's
consideration regarding Oxycontin on behalf of our pharmacists and
pharmacy staff at CVS/pharmacy:
OXYCONTIN
Oxycontin, a controlled release oxycodone, entered the prescription
drug market in 1995 as an opioid agonist and a Schedule II controlled
substance indicated for the management of moderate-to-severe pain when
a continuous around the clock analgesic is needed for an extended
period of time. It was not intended for use on what the medical and
pharmacy community would term a ``prn'' basis. PRN is an abbreviation
of a Latin term (pro re nata) that means as needed.
Oxycontin is an extremely effective drug when prescribed for its
intended use. The drug has a legitimate use of providing long-term pain
relief especially to those who experience chronic pain and terminal
cancer patients. These patients can maintain a better quality of life
by ingesting fewer tablets and experiencing longer periods of time
without pain.
ABUSE OF OXYCONTIN
Unfortunately, Oxycontin, like other opiates, has a high potential
for abuse, whether legal or illicit. The media made the public aware
that chewing, crushing, dissolving and injecting, snorting, or smoking
the drug would provide a quick heroin-like euphoria.
Inappropriate prescribing, prescription fraud, prescription rings
engaging in ``Doctor Shopping'', employee thefts, increased number of
evening break-ins, and armed robberies, have been the direct result of
the abuse of Oxycontin.
According to Jay P. McCloskey, a former U.S. Attorney in Maine from
April 1993 to May 2001, Oxycontin was the prescription opiate most
widely abused in Maine, with the exception of one county. He also noted
that the speed with which prescription opiates and heroin became
established among a growing population of high school age youth and
kids in their late teens and early twenties was alarming and that these
drugs were being used on a recreational basis.
ARMED ROBBERIES SPECIFICALLY FOR OXYCONTIN
Oxycontin losses in the form of employee pilferage and armed
robberies were minimal until 2001.
For example, robbery loses in Massachusetts:
7 (1 armed robbery)
27 (5 armed robberies)
25 (2 armed robberies)
105 (87 armed robberies)
From Jan to Feb 7, 2002 13 (13 armed robberies)
These figures were obtained from the Massachusetts Board of
Pharmacy.
As you can see, Oxycontin targeted armed robberies are rising at an
alarming rate. In addition to Massachusetts, Oxycontin armed robberies
have occurred in Maine, Virginia, West Virginia, Kentucky, Alabama, New
Hampshire, Vermont, Florida, Indiana and Rhode Island.
This is extremely frightening for all pharmacists, pharmacy staff,
and their families. Some pharmacists have been robbed more than once.
Some of the robberies have been violent. The incidences of armed
robberies were rare prior to the onset of Oxycontin abuse.
We are very concerned about the safety of our colleagues as long as
this drug is on the market in its current formulation.
ACTIONS REQUESTED FROM THE HELP COMMITTEE
Increase penalties for individuals who commit armed
robberies of healthcare providers.
Encourage Purdue Pharma, L.P., manufacturer of Oxycontin,
to reformulate the product to reduce the potential for abuse. It is our
understanding that Purdue Pharma is working on this process. Please
urge them to accelerate their activities.
Encourage the FDA to ``Fast Track'' any reformulated
product application.
We believe that these actions would significantly reduce the abuse
of Oxycontin without significantly reducing its effectiveness as a pain
relief medication or its availability. These actions would also help to
protect health care workers, especially community pharmacists. At a
time when pharmacists are in short supply and great demand, many
community pharmacists are rethinking their decision to practice in the
community. This, in many cases, is the direct result of the threat of
violence attributable to the armed robberies associated with Oxycontin
abuse.
Thank you for your consideration in this matter.
Statement of the American Academy of Family Physicians
This statement is submitted to the Senate Health, Education, Labor,
and Pensions Committee on behalf of the 93,100 members of the American
Academy of Family Physicians (AAFP). The subcommittee will hear
testimony today concerning OxyContin diversion and abuse.
OxyContin is a slow-release form of oxycodone
hyrdochloride intended to treat moderate to severe chronic pain for up
to 12 hours. When used appropriately, it is a safe, effective long-
lasting opioid that has improved pain management and given new hope to
thousands suffering from moderate to severe pain.
In recent months, news reports have noted the growing illicit use
of OxyContin, occasionally with deadly consequences. The
medicine is a powerful narcotic with chemical compounds similar to
morphine. The user experiences the full narcotic effect by tampering
with the time-release coating and taking the drug intravenously or
nasally. The pharmaceutical, when abused, is highly addictive. The
resulting cases of addiction have led to a serious diversion problem in
several states. Reports of OxyContin diversion and abuse are
disturbing both because of the speed with which this illicit use has
occurred in rural, economically depressed communities and because of
the deaths reportedly linked with the drug.
THE ROLE OF THE FAMILY PHYSICIAN IN TREATING PAIN
To address the growing problem of OxyContin abuse without
harming legitimate medical patients, it is essential to understand the
role of the family physician in pain management. Family physicians see
patients as the first point of contact for undiagnosed symptoms, the
coordination of ongoing care plans and the management of multiple
chronic medical conditions. We treat patients of all ages, often seeing
patients through the end of their lives. Appropriate pain management
is, therefore, an integral aspect of family medicine.
Family physicians take seriously the important responsibility of
treating the entire person. According to ``Facts About Family
Practice'' published by the AAFP based on data from the Department of
Health and Human Services, family doctors receive one out of every four
office visits made to all physicians. Family doctors are a vitally
important source of medical care, including the managing of pain, for
millions of Americans.
THE ROLE OF THE PAIN SPECIALIST
Family physicians often work in conjunction with pain specialists.
Typically, family physicians either refer patients or request a
consultation with a pain specialist in cases where the family physician
is seeking an advisory opinion. Patients remain under the care of the
family physician, who retains responsibility for coordinating their
overall medical care, including the management of their pain. Given all
that we do for patients in pain, even in consultation with pain
specialists, it is not surprising that the American Academy of Hospice
and Palliative Medicine reports 22 percent of its members serving as
medical directors are family physicians.
FEDERAL RESPONSE TO PROBLEMS WITH OXYCONTIN
The problems of diversion and abuse that have arisen with
OxyContin have demanded a response from federal law
enforcement and regulatory agencies. Unfortunately, in several public
statements and in testimony before Congress, several state and federal
law enforcement officials have suggested that the right to prescribe
OxyContin should be limited to pain management specialists.
Such proposals are troubling since they would create an immediate
medical crisis for patients in legitimate need of pain management,
especially in rural and underserved communities where family physicians
are more likely to be practicing. The American Board of Pain Medicine
lists only 1,179 certified pain specialists nationally who focus their
medical practice on pain relief and treatment. Additionally, limiting
the prescribing rights of certain physicians would create a dangerous
new precedent of federal intervention into the practice of medicine.
The American Academy of Family Physicians views such proposals as
detrimental to the health of our patients and urges Congress to oppose
such recommendations.
The AAFP recognizes the legitimate law enforcement authority of the
federal Drug Enforcement Administration (DEA) and local law enforcement
officials to prosecute physicians who are illegally prescribing
OxyContin. Physicians who abuse their prescribing privileges
should not be allowed to hide behind their medical license to avoid
strong and appropriate law enforcement penalties.
However, responses other than restricting prescription rights are
more effective. For example, the Food and Drug Administration (FDA)
recently suggested changes to the labeling of OxyContin. This
new labeling includes a black box warning alerting physicians to the
potential for abuse and addiction although OxyContin
continues to be approved for use in patients with moderate to severe
pain who require continuous opioids for an extended period of time to
adequately control their pain. The Academy commends the FDA for
ordering these labeling changes and believes that the new labeling
appropriately indicates the importance of careful physician
supervision, as well as the potential for diversion that this drug
poses.
The AAFP also recognizes that a federal response to diversion and
abuse of OxyContin is not enough. Physicians have a
corresponding responsibility to provide thorough patient assessments
and continued monitoring of patients for whom they have prescribed
OxyContin.
THE AAFP RESPONSE TO PROBLEMS WITH OXYCONTIN
The Academy is responding to concerns about OxyContin by
educating physician members about the medicine's potential for
diversion and abuse. In the August 2001 FP Report, the Academy
published an article entitled, ``Two Faces of OxyContin in an
effort to highlight concern over its abuse and the need to effectively
screen patients for potential addiction. The article directed family
physicians to the Center for Substance Abuse Treatment (CSAT) within
the Substance Abuse and Mental Health Services Administration to obtain
``Treatment Improvement Protocols'' published by CSAT.
The article also highlighted a variety of methods for protecting
the authenticity of physician prescriptions, as well as characteristics
to beware of in strange or new patients who may be ``doctor shopping.''
These included recommendations to protect prescriptions by keeping pads
in secure locations and never signing an incomplete prescription.
Family physicians were advised to write the quantity and strength of
drugs on prescriptions in letters and numbers and to use tamper-proof
prescription pads that could not be photocopied. The article also
stated that prescriptions should include the name of the pharmacy that
the patient intended to use or that they should be faxed directly to
the pharmacy for authentication. Family physicians were advised in the
article to never write their medical license on an empty prescription
pad, but to include it as the prescription was written out.
Since ``doctor shopping'' is one of the methods that has been used
to divert OxyContin, the article goes on to advise family
physicians to be wary of any stranger who:
wants an appointment at the end of office hours or arrives
after regular hours;
demands immediate action;
refuses a physical exam, permission to obtain medical
records or undergo any diagnostic tests;
is unable to give name of regular physician (may claim no
health insurance);
cannot recall hospital/clinic where past records are
located or says it went out of business;
has lost prescription, has forgotten to pack prescription,
or says it was stolen;
exaggerates or feigns medical symptoms;
recites textbook symptoms with a vague medical history;
has no interest in diagnosis or referral--wants a
prescription now;
shows unusual knowledge of controlled substances;
requests a specific controlled substance and is unwilling
to try another medication;
states that specific nonopioid analgesics do not work or
claims allergy to them.
In addition, the state chapters of the Academy have undertaken a
variety of activities addressing long-term opioid prescribing. Such
activities include continuing medical education seminars on appropriate
pain management and screening abuse in Ohio, Texas, Mississippi,
Alabama, and Tennessee. In addition, our chapters in Kentucky,
Tennessee, Alabama, and Ohio have published articles outlining the
importance of appropriate patient selection, screening for addictions,
coordinating with pharmacists and other specialists to develop a care
plan that also prevents diversion and assures long-term monitoring of
the patient. All of these activities have stressed the importance of
appropriate pain management including an assessment of the patient's
pain, addressing nonopioid analgesics as a first resort, and
appropriately monitoring patients who have been prescribed
OxyContin to preclude the possibility of diversion.
The Academy has addressed pain management in its publication,
American Family Physician. Two recent articles were published in
American Family Physician, ``Twelve Pitfalls of Adequate Pain Control''
(September 1997) and ``Physician Attitudes a Barrier to Pain
Management'' (November 2000).
In addition, the Academy also has sent a letter to all state
Attorneys General, expressing the Academy's interest in working
collaboratively to prevent the diversion and abuse of
OxyContin and objecting to suggestions that the right to
prescribe this effective pain management medicine be restricted to pain
management specialists. The letter asks each Attorney General to
contact the appropriate state chapter of the Academy to find out which
education efforts have been undertaken at the state and local level.
Further, the Academy is educating physicians on strategies for
identifying all forms of addiction and substance abuse. Earlier this
spring, the Academy partnered with the National Institute on Drug Abuse
(NIDA) and six other organizations to launch the National Initiative on
Prescription Drug Misuse and Abuse. In AAFP publications sent to the
entire membership, the Academy highlighted the NIDA online publication,
Research Report Series: Prescription Drug Abuse and Addiction.
Finally, the Academy sponsors continuing medical education
conferences that address addiction screening. At the AAFP's 23rd Annual
Conference on Patient Education, which will be held in Seattle from
November 15-18, 2001, the Academy will sponsor a lecture on recognizing
the signs and symptoms of prescription medication addiction in specific
populations. The Academy is currently exploring the possibility of
producing continuing medical education materials, in both traditional
and online formats, on appropriate pain management.
CONCLUSION
In closing, the AAFP is concerned that effective medicines, such as
OxyContin, remain accessible to primary care physicians and
their patients who are in chronic pain. Likewise, the Academy is
concerned about the illicit use of OxyContin and has
addressed the potential for its abuse in several ways. Through
continuing medical education at the state and national level, the
Academy has focused on drug abuse and OxyContin in
particular. Recent changes in the labeling of OxyContin are
important steps towards ensuring its appropriate use under the ongoing
care of a physician.
The AAFP supports the response of the FDA in seeking
OxyContin labeling changes and of the DEA in prosecuting the
illegal activity of physicians wherever it may occur. The Academy is
committed to working with federal law enforcement officials and
regulators to help family physicians care appropriately for their
patients who are in pain.
The Academy appreciates the opportunity to submit this statement
for the record to the Senate Health, Education, Labor, and Pensions
Committee. We look forward to working with you to end the illicit use
of OxyContin without neglecting those patients who
legitimately need relief from chronic or severe pain.
Prepared Statement of Russell K. Portenoy, M.D.
I am grateful for this opportunity to contribute these comments to
the Committee. I have extensive background in the area of pain
management and opioid pharmacology. I am Chairman of the Department of
Pain Medicine and Palliative Care at the Beth Israel Medical Center in
New York City and Professor of Neurology at the Albert Einstein College
of Medicine. I am a Past President of the American Pain Society,
current Secretary of the International Association for the Study of
Pain, a Director of the American Pain Foundation and the National
Hospice Foundation, and Vice-Chairman of the American Board of Hospice
and Palliative Medicine. For almost two decades, I have specialized in
the treatment of patients with chronic pain and have been an educator
and clinical investigator in the areas of pain and opioid pharmacology.
I have had a particular interest in exploring the relationship between
pain management and chemical dependency, and have helped organize four
international conferences devoted to this topic.
My testimony is focused on the medical use and abuse of Oxycontin
and is based on my experience as a clinician and my knowledge of pain
medicine and opioid therapy. As disclosure, I will state that I have
accepted honoraria for participating in educational symposia sponsored
by several corporations that manufacture opioid drugs, including Purdue
Pharma, and that my department has received grants from these companies
for projects involving professional education and research.
Before September 11, media attention on Oxycontin abuse was
intensifying. Frightening statistics concerning abuse, and the poignant
stories of people whose lives have been damaged by addiction to
Oxycontin, have justifiably raised concerns about the dangers
associated with this drug. Some are now questioning the wisdom of
continuing business as usual in providing access to Oxycontin, and
perhaps to other potentially abusable drugs with legitimate medical
purposes.
At the same time, however, the stories of abuse and addiction, and
the potential for increased regulation of opioid drugs, have raised
intense worries among pain specialists and patient advocates, who fear
that over-regulation, ill-conceived enforcement policies, and worsening
social stigma will lead to more undertreatment of pain, and hence more
suffering for the millions of people with painful disorders.
The latter fear--that the unintended effects of regulation could
hurt patients--was forcefully illustrated to me by two recent personal
experiences. First I learned that a family member who requires long-
term opioid therapy for a serious pain problem was told by her
pharmacist that he would not dispense her medication any longer because
he did not want to have patients who received such drugs on a regular
basis. Soon thereafter, three of five patients I was seeing during one
treatment session spontaneously expressed great fear that the
government would ``take away'' their Oxycontin, causing them to return
to states of unrelieved pain and severe disability. The government's
response to Oxycontin abuse affects patients, and their interests must
be considered.
STATUS OF OPIOID THERAPY IN THE UNITED STATES
To frame this issue, it is informative to review the history of
opioid therapy during the past two decades. Since the 1980's, there has
been a worldwide clinical consensus that opioid drugs should be the
first-line treatment approach for severe acute pain and moderate to
severe chronic cancer pain. Despite this consensus, numerous studies of
cancer pain have demonstrated that opioid use often does not conform to
published guidelines. The problem of undertreatment is complex, but it
is certainly due, at least in part, to physician limitations, including
inadequate knowledge of prescribing principles, an unrealistic fear of
addiction and side effects, and concerns about regulatory scrutiny.
This last issue--fear of the government's reaction to the medical
use of opioids--is very real and should be emphasized in this context.
A 1998 survey of more than 1300 New York State physicians, for example,
revealed that more than half were moderately to very concerned about
regulatory oversight and that one-quarter to one-half admitted to
changing their prescribing practices solely because of such concerns.
Despite persistent undertreatment, cancer patients did begin to
benefit from pain treatment advances and clinician education in the
1980's. The release on the U.S. market of long-acting opioid drugs, the
first of which was a morphine formulation developed by Purdue Pharma
called MS Contin, was a significant advance in treatment. Purdue Pharma
followed the launch of this drug with an extensive educational program,
which was focused on the problem of cancer pain and sought to improve
acceptance of opioid therapy by providing information and dispelling
deeply held myths and misconceptions about these drugs. The later
release on the market of other long-acting opioids was accompanied by
similar marketing and educational strategies.
As opioid use for cancer pain was being encouraged, pain
specialists began a major shift in thinking about the role of these
drugs for noncancer pain. After more than a decade of debate, a 1997
consensus statement jointly issued by the American Pain Society and the
American Academy of Pain Medicine rejected the traditional negative
view of this therapy and acknowledged that long-term opioid
administration was clearly beneficial for selected patients with
chronic pain. A similar consensus statement followed from the American
Society of Addiction Medicine. In response to this changing
perspective, and the ongoing problem of undertreatment, the regulatory
community and many state legislatures have tried to reassure clinicians
that the legitimate use of opioids will not place them at risk of
investigation or sanction.
Most pain specialists now recognize that opioids are no panacea for
chronic noncancer pain, but are nonetheless probably greatly underused
in the management of painful disease. Given the extraordinary
prevalence of chronic pain, which is estimated to affect at least 50
million people in the U.S. alone, pain specialists generally also
believe that primary care physicians must become skilled in the
administration of opioids, and comfortable with the approach, if there
is to be any hope that the benefits associated with these drugs can be
brought to those who are appropriate to receive them.
Pain specialists and other physicians also recognize that the
opioids are potentially abusable drugs. They may be diverted to illicit
use, and patients who are predisposed to addiction may get into trouble
when administered one of these drugs for a legitimate medical purpose.
In this context, it is important to recognize that the word
``addiction'' refers to a disease characterized by loss of control over
the drug, compulsive use, and use despite harm. This disease, which has
a strong genetic predisposition, can be activated by many types of
medicine, including opioids. When prescribing any potentially abusable
drug, the physician has an obligation to select patients carefully,
monitor drug-related behaviors, and control the therapy. This is
particularly important in patients with a history of chemical
dependency, and in those who may be predisposed to develop addiction.
PERSPECTIVES ON OXYCONTIN ABUSE AND ADDICTION
The active ingredient in Oxycontin, the opioid oxycodone, has been
commercially available for decades. Oxycontin provides a convenient
long-acting delivery system for a drug that is commonly administered in
many short-acting proprietary and generic formulations. There is no
scientific evidence that oxycodone causes abuse or true addiction at
any greater rate than any other opioid in its class. From the medical
perspective, however, there is good evidence that individual patients
vary greatly in their responses to different opioids, and that some
patients have a much better outcome when given oxycodone than other
opioid drugs. Experience with Oxycontin among pain specialists has
confirmed that it is a convenient formulation that provides
extraordinary benefit for some patients, and is less preferred by
others.
When Purdue Pharma was developing Oxycontin, it opted to study the
drug in populations with chronic noncancer pain, including those with
arthritis pain and low back pain. The studies were positive. After the
drug's launch, the company chose to market it to nonspecialists, and
were permitted to do so based on the data from these studies. Their
marketing, and the educational program they pursued in the primary care
community, was very similar in style to the strategy that they and
other companies pursued in trying to improve the management of cancer
pain. It focused on benefits of pain control and the problem of
undertreatment, taught the principles of opioid therapy, and tried to
dispel the myths and misconceptions that stigmatize opioids and are
barriers to appropriate opioid prescribing. This educational program
did not strongly address the potential liabilities of abuse and
addiction.
Presumably, the combination of marketing and education in the
primary care community, combined with an enormous unmet need among
patients, led to a rapid increase in Oxycontin prescribing. As sales
increased, pockets of serious abuse began to occur, particularly in
populations with known histories of abuse or addiction.
The reports indicate that most abuse and addiction occurred among
those with known histories of chemical dependency. Undoubtedly,
however, some abuse and addiction occurred among those who had not
experimented much with opioid drugs before, but were predisposed to
develop problems and were given Oxycontin for pain by a well-
intentioned physician. For these individuals, Oxycontin was a
``gateway'' drug to serious abuse.
There is no evidence that the amount of abuse by known abusers, or
the amount of ``gateway'' use, has been more than would be expected
with any opioid that had a similarly rapid increase in medical use over
a short time. It is also impossible to know whether the media attention
on the drug is partly responsible for spread of abuse.
Having said this, however, it also is a reasonable presumption that
the Oxycontin problem is greater than would have occurred if the
marketing to clinicians had focused more on the potential liabilities
of therapy, including the potential for abuse and addiction. The
problem is presumably greater than would have occurred if the makers of
Oxycontin, the makers of other opioids, and professional medical
societies had been providing educational programs for physicians that
had included more about the management of addictive disease.
A BALANCED APPROACH TO SOLUTIONS
The approach to opioid drugs with legitimate medical purposes must
derive from three perspectives. First, we should all recognize that
access to opioid therapy is essential for millions of patients with
acute and chronic pain. In this regard, we should all acknowledge that
the epidemic of undertreated pain is a huge public health problem, that
opioid drugs can be safe and effective but are medically underused, and
that the underuse of opioid drugs is partly determined by stigma
associated with addiction and by physician fear of regulatory
oversight.
Second, we should all agree that decisions concerning the
regulation of opioid drugs should be based on the available scientific
information and be informed by accumulated clinical experience. Policy
should not be driven by anecdote or fear.
Third, we should all acknowledge that the potential for abuse and
addiction is a liability associated with these drugs and that both
clinicians and those in government have a common interest in minimizing
these negative outcomes while ensuring appropriate medical use. In this
regard, the problem of Oxycontin abuse has been something of a ``wake-
up call'' for those of us who believe that opioid therapy should be
expanded and that the primary care community must take on this therapy
to meet the needs of patients. It is now clear that physicians who wish
to help patients by providing long-term opioid therapy must have the
knowledge and skills to both optimize benefit and minimize risk.
These perspectives must be considered in discussing the
government's response to the problem of Oxycontin abuse. What would a
reasonable response be? We must first avoid extreme reactions that
could have unintended negative consequences. Of course, actions that
would limit access to Oxycontin also would probably lessen its abuse.
The great concern, however, is that regulatory or law enforcement
initiatives intended to reduce diversion and abuse may have the
unintended effect of reducing the availability for patients who are
truly in need. The clinical community already undertreats, in part,
because of fear of the regulators. Any extreme response to Oxycontin
abuse, such as eliminating prescribing by nonspecialists or removing
the drug from retail pharmacies, would do more than directly damage the
large number of patients now benefiting from Oxycontin. It would have a
``chilling effect'' on prescribing overall and increase the fear of
these drugs among prospective patients and the public. The overall
result would be more undertreatment.
The government must not interpret less prescribing as equal to less
abuse. For example, eliminating Oxycontin from state medical programs
for the indigent might lessen prescribing, but where is the evidence
that this directly addresses the problem of abuse or addiction? This
type of action is not justified without such evidence.
At the same time, we do need to be circumspect about the marketing
of opioid drugs to the primary care community. Marketing must be done
in tandem with education and support. We are not yet ready for direct
marketing of opioids to the public.
We need to encourage an ongoing dialogue between clinicians and
those in the regulatory and law enforcement communities. To their
credit, the DEA and the FDA are already reaching out to the clinical
community. The DEA should be particularly commended for joining with a
large number of professional medical societies, including the American
Medical Association and the American Pain Society, in signing on to a
consensus statement supporting the concept of a balanced approach to
opioid drugs. This type of collaboration should be duplicated by law
enforcement and regulators in every state, particularly those affected
by a high level of Oxycontin abuse. It will help ensure that no action
is taken without a careful review of the potential impact on the
problem of undertreated pain.
We need the government to encourage improved education for
prescribers and pharmacists. Education should be pursued through
partnerships among professional societies, industry, and government
agencies.
We also need the government to support research related to many
aspects of pain and chemical dependency. This is the Decade of Pain
Control and Research, but research in pain is still woefully
underfunded. We need studies to define the risk of abuse and addiction,
determine the relative impact of many factors that could be
contributing to these outcomes, and investigate various interventions
to reduce abuse without adverse effects on pain management. If new laws
or regulations are pursued, they should be accompanied by ongoing study
of their effects on pain patients.
Finally, the treatment available for patients with addictive
disease is inadequate. The current drug abuse treatment community needs
support to develop models and novel therapies that can address the
problem of opioid abuse in patients with acute and chronic pain.
[Whereupon, at 5:12 p.m., the committee was adjourned.]