[Senate Hearing 107-287]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 107-287

                OXYCONTIN: BALANCING RISKS AND BENEFITS

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

                                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

77-770              U.S. GOVERNMENT PRINTING OFFICE
                            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

                                 ______

                                  (ii)

  




                            C O N T E N T S

                               __________

                               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

                              ----------                              


                       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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \3\ Statistics, DEA, Office of Diversion Control.
    \4\ The Medical Letter Sept. 17, 2001.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \5\ Statistics DEA Office of Diversion Control.
---------------------------------------------------------------------------
    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;
---------------------------------------------------------------------------
    \6\ The Medical Letter Sept. 17, 2001
---------------------------------------------------------------------------
    (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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \5\ FDA letter to Dr. Richard Sackler, President, Purdue--available 
for review on the FDA web site.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \9\ Statistics, DEA, Office of Diversion Control.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------
    \10\ U.S. map of OxyContin consumption by state, DEA, Office of 
Diversion Control.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.]

                                    
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