[Senate Hearing 110-479]
[From the U.S. Government Publishing Office]
S. Hrg. 110-479
EVALUATING THE PROPRIETY AND ADEQUACY OF THE OXYCONTIN CRIMINAL
SETTLEMENT
=======================================================================
HEARING
before the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
JULY 31, 2007
__________
Serial No. J-110-50
__________
Printed for the use of the Committee on the Judiciary
----------
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COMMITTEE ON THE JUDICIARY
PATRICK J. LEAHY, Vermont, Chairman
EDWARD M. KENNEDY, Massachusetts ARLEN SPECTER, Pennsylvania
JOSEPH R. BIDEN, Jr., Delaware ORRIN G. HATCH, Utah
HERB KOHL, Wisconsin CHARLES E. GRASSLEY, Iowa
DIANNE FEINSTEIN, California JON KYL, Arizona
RUSSELL D. FEINGOLD, Wisconsin JEFF SESSIONS, Alabama
CHARLES E. SCHUMER, New York LINDSEY O. GRAHAM, South Carolina
RICHARD J. DURBIN, Illinois JOHN CORNYN, Texas
BENJAMIN L. CARDIN, Maryland SAM BROWNBACK, Kansas
SHELDON WHITEHOUSE, Rhode Island TOM COBURN, Oklahoma
Bruce A. Cohen, Chief Counsel and Staff Director
Michael O'Neill, Republican Chief Counsel and Staff Director
C O N T E N T S
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STATEMENTS OF COMMITTEE MEMBERS
Page
Coburn, Hon. Tom, a U.S. Senator from the State of Oklahoma...... 4
Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont. 1
prepared statement........................................... 126
Specter, Hon. Arlen, a U.S. Senator from the State of
Pennsylvania................................................... 2
WITNESSES
Brownlee, John L., U.S. Attorney, Western District of Virginia,
Roanoke, Virginia.............................................. 6
Campbell, James N., M.D., Professor of Neurosurgery, School of
Medicine, Johns Hopkins University, Baltimore, Maryland........ 28
Khanna, Vikramaditya, Professor of Law, University of Michigan
Law School, Ann Arbor, Michigan................................ 20
McCloskey, Jay P., former United States Attorney, District of
Maine, McCloskey, Mina, Cunniff & Dilworth, LLC, Portland,
Maine.......................................................... 27
Pagano, Virginia, Police Officer, Philadelphia Police Department,
Narcotics Bureau, Philadelphia, Pennsylvania................... 25
Skolek, Marianne, LPN, Myrtle Beach, South Carolina.............. 18
Wolfe, Sidney M., M.D., Director, Health Research Group of Public
Citizen, Washington, D.C....................................... 22
QUESTIONS AND ANSWERS
Responses of John L. Brownlee to questions submitted by Senators
Leahy and Specter.............................................. 33
Responses of James N. Campbell to questions submitted by Senator
Specter........................................................ 46
Responses of Vikramaditya Khanna to questions submitted by
Senator Specter................................................ 51
Responses of Jay P. McCloskey to questions submitted by Senators
Coburn and Specter............................................. 56
Responses of Virginia Pagano to questions submitted by Senator
Specter........................................................ 67
Responses of Marianne Skolek to questions submitted by Senator
Specter........................................................ 71
Responses of Sidney M. Wolfe to questions submitted by Senator
Specter........................................................ 74
SUBMISSIONS FOR THE RECORD
Blumenthal, Richard, Attorney General, State of Connecticut,
Hartford, Connecticut, statement and attachment................ 77
Brownlee, John L., U.S. Attorney, Western District of Virginia,
Roanoke, Virginia, statement and attachment.................... 82
Campbell, James N., M.D., Professor of Neurosurgery, School of
Medicine, Johns Hopkins University, Baltimore, Maryland,
statement...................................................... 110
Hutt, Peter Barton, Covington & Burling LLP, former Chief Counsel
of the Food and Drug Administration, Washington, D.C., letter.. 117
Khanna, Vikramaditya, Professor of Law, University of Michigan
Law School, Ann Arbor, Michigan, statement..................... 120
Levy, Michael H., M.D., Vice-Chair, Department of Medical
Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania,
letter......................................................... 128
McCloskey, Jay P., former United States Attorney, District of
Maine, McCloskey, Mina, Cunniff & Dilworth, LLC, Portland,
Maine, statement............................................... 132
National Survey on Drug Use and Health, 2005, charts............. 142
Pagano, Virginia, Police Officer, Philadelphia Police Department,
Narcotics Bureau, Philadelphia, Pennsylvania, statement........ 143
Reynolds, Siobhan, Founder and President, Pain Relief Network,
statement...................................................... 148
Shapiro, Howard M., Partner, Wilmer Cutler Pickering Hale and
Dorr LLP, Washington, D.C., statement and attachment........... 153
Skolek, Marianne, LPN, Myrtle Beach, South Carolina, statement... 162
Wolfe, Sidney M., M.D., Director, Health Research Group of Public
Citizen, Washington, D.C., statement........................... 167
EVALUATING THE PROPRIETY AND ADEQUACY OF THE OXYCONTIN CRIMINAL
SETTLEMENT
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TUESDAY, JULY 31, 2007
U.S. Senate,
Committee on the Judiciary,
Washington, DC.
The Committee met, pursuant to notice, at 2:36 p.m., in
room SD-226, Dirksen Senate Office Building, Hon. Patrick J.
Leahy, Chairman of the Committee, presiding.
Present: Senators Leahy, Cardin, Specter, Sessions, and
Coburn.
OPENING STATEMENT OF HON. PATRICK J. LEAHY, A U.S. SENATOR FROM
THE STATE OF VERMONT
Chairman Leahy. Good afternoon, Dr. Coburn. We are just a
minute or two late because we were all at our various caucuses,
but I had scheduled this hearing at the request of the
distinguished senior Senator from Pennsylvania. Senator Specter
has long expressed an interest in criminal liability for the
introduction of dangerous or defective products into the
marketplace. I agree with him that this is a very important
issue and one where further congressional action may be
warranted.
The hearing will examine the recent plea agreement between
the makers of OxyContin and the Federal Government. Last month,
this Committee held a hearing addressing the role of rogue
online pharmacies in our Nation's growing prescription drug
abuse problem. Among young people, prescription drugs have
become the second most abused illegal drug, behind marijuana.
In fact, if you exclude marijuana, more adults and teens report
abusing prescription drugs than all other illicit drugs
combined. I noted then that Purdue's admitted
misrepresentations about the addictiveness and abuse potential
of their product was very troubling.
The criminal conduct involved in the marketing of OxyContin
has been one of the most tragic examples in recent memory of a
company favoring the bottom line over the health of our
Nation's citizens. The tragic irony is that the dangerous
product they were talking about purported to help people manage
pain. And I know that for many it has been effective. But for
many others, this drug, and its diversion due to widespread
distribution, has caused terrible harm--from addiction to in
many instances death. Purdue made billions of dollars marketing
OxyContin as a less addictive alternative to painkillers.
Today, we will hear about what punishment the Justice
Department found appropriate for this criminal conduct.
I look forward to discussing today with the witnesses how
best to prevent this type of dangerous corporate decisionmaking
from ever occurring again. Americans should not have their
lives reduced to a mere factor in an actuarial table. While the
makers of OxyContin have been prosecuted, have pled guilty, and
are paying a multi-million dollar fine, no one from the company
is going to jail. Frankly, I felt in my days as a prosecutor
and I am sure others, like Senator Specter, who had the
privilege of serving as prosecutors know that nothing focuses
the mind as much as thinking you are going to be behind bars.
Fines can sometimes become simply a cost of doing business.
When you sit behind bars, you think far more about whether you
did the right thing.
I believe it is fair to ask, in light of Purdue's profits
of approximately $2.8 billion between 1996 and 2001, whether
the $680 million in penalties they received in this plea
agreement will serve as a deterrent to similar future conduct
or just simply become part of the cost of doing business.
We will hear testimony today about the way Purdue's conduct
has affected the lives of those who have lost loved ones as a
result of taking OxyContin. Many are asking why the three
executives who pled guilty were not given jail time. As I said
before, nothing makes corporate executives think twice about
malfeasance more than the prospect of the iron bars slamming
shut.
The judge who presided over the plea agreement stated at
the sentencing hearing: ``I do not doubt that many of our
fellow citizens...will deem it inappropriate that no jail time
is imposed. It bothers me, too.'' I would say to the judge it
certainly bothers me.
The United States Attorney who prosecuted the case will
testify today about why he did not insist that the responsible
corporate officials pay a similar price as the individuals who
sell OxyContin on the street. I look forward to hearing from
these witnesses.
[The prepared statement of Senator Leahy appears as a
submission for the record.]
Senator Specter?
STATEMENT OF HON. ARLEN SPECTER, A U.S. SENATOR FROM THE STATE
OF PENNSYLVANIA
Senator Specter. Thank you, Mr. Chairman, for scheduling
this hearing.
The criminal charge involves a matter where there was a
plea to a felony offense, including an intent to mislead.
According to the DEA, in just 2000 and 2001, there were 146
deaths in which OxyContin was determined to be the direct
``cause of'' or ``a contributing factor to'' the deaths and an
additional 318 deaths that were ``most likely'' caused by
OxyContin. In seeing the reports on this matter, with very
substantial profits involved and a fine, albeit substantial, it
has a very ominous overtone of insufficient prosecution
efforts. Where someone places a dangerous instrumentality in
commerce with reason to believe that a death may occur and a
death does occur, that constitutes malice and supports
prosecution for murder in the second degree.
I have long expressed my concern about such products in the
marketplace, and that is why I suggested to Chairman Leahy that
a hearing would be useful.
I believe that as a generalization--and I base this on
substantial experience on this Committee--that there is
insufficient oversight by the Committee on what happens in the
Department of Justice and what happens in the criminal
prosecutions.
I have since been contacted by attorneys representing the
defendant company who contend that there is a gross
misstatement of what the underlying facts are. Well, I am
prepared to listen. This Committee is prepared to listen. But
Senator Leahy puts his finger on the issue, that is, if there
is reason to believe that it is a dangerous instrumentality and
that deaths will occur and deaths do occur, that supports a
homicide prosecution. And it is not deterred by a fine.
I see fines with some frequency and think that they are
expensive licenses for criminal misconduct. I do not know
whether that applies in this case, but a jail sentence is a
deterrent and a fine is not--not a corporate fine in the
context of the kind of profits which are involved here.
Since this hearing was scheduled, we have a very heavy
commitment this afternoon to the Director of National
Intelligence. We have been called upon to revise the FISA law,
so at least speaking for myself, I am going to have to conclude
my participation by 4 o'clock. I do not control the gavel, but
the Chairman--
Chairman Leahy. If you would yield on that, you will
control the gavel, because I am going to be leaving before
that.
Senator Specter. If I control the gavel, the hearing will
be over by 4 o'clock.
Chairman Leahy. And I am going to turn the gavel over to
you.
Senator Specter. Well, we have the time limits of 5
minutes, and if I have the gavel, I would request--in fact,
even if I did not have the gavel, I would request the witnesses
stay within the time limits to give the maximum time for
dialog. But we have enough time to give this a thorough
hearing.
I had a call from Senator Coburn, who is concerned about
the adequacy of the witness list, and I immediately said the
witnesses he wanted to add I thought were fine. And we have an
expert here--we have a couple of experts: one in the medical
field and one in the legal field. So we will see how it goes.
Thank you, Mr. Chairman.
Chairman Leahy. Thank you.
Mr. Brownlee, would you please stand and raise your right
hand? Do you solemnly swear that the testimony you will give in
this matter will be the truth, the whole truth, and nothing but
the truth, so help you God?
Mr. Brownlee. Yes, sir.
Chairman Leahy. Thank you.
Senator Coburn. Mr. Chairman, might I have the privilege of
having an opening statement?
Chairman Leahy. Certainly.
STATEMENT OF HON. TOM COBURN, A U.S. SENATOR FROM THE STATE OF
OKLAHOMA
Senator Coburn. First of all, what has happened with
OxyContin in terms of how it has been abused represents some of
the greatest problems we have in this country with poly drug
abuse. As a practicing physician, as a cancer survivor, as
somebody who has prescribed this medicine, I am somewhat
concerned with the direction we are taking, and the question I
would ask of the Chairman and the Ranking Member is: Where is
our study on Lortab and the drug and poly drug abuse with
Lortab? Where is our study and our hearing on Coumadin and the
people that die every year from Coumadin? The facts are that 98
percent of the people who died using this drug are poly drug
abusers.
Now, whether there was intent to distribute outside of
there--but I think it is really important that everybody
recognizes what a Class II drug is. It is a highly addictive
drug. And where is the question and the culpability on the
medical community in this country who wrote the prescriptions
for this drug? They read the PDR. They read the approved
statement, which fully outlines the dangerousness of this drug
when used in an inappropriate manner.
The thing that concerns me, never was it alleged that this
drug was designed to be ground up and used in an illegal
fashion and that there was a motivation to do that. And yet we
are coming after a drug manufacturer who may or may not--
according to the plea, has pled guilty to something, but we are
turning a blind eye to all the other areas.
The problem in this country is poly drug abuse. Ninety-
eight percent of the people who have died with this on autopsy
are found to have multiple other drugs.
Look at the other side of it. Look at somebody who has bone
pain from metastatic bone cancer and say, Do we not want them
to have this wonderful drug that makes life bearable instead of
unbearable? We are not considering this in a balanced fashion,
and I believe as a physician, No. 1, I ought to challenge my
own profession. They created this problem by not following
their own ethical standards and by writing prescriptions for
drugs that they never should have written. And the same thing
is going on with Lortab right now.
Final point. We need to be careful that we do not act as
the FDA. This was an approved drug under Schedule II that
everybody in the medical community understands the addictive
potential and the danger of. And to hold no culpability for the
physician community I think would be seriously in error.
And I thank the Chairman for allowing me an opening
statement.
Chairman Leahy. Thank you.
Mr. Brownlee, I expect that you are aware that your name
appeared on at least one termination list of U.S. Attorneys.
The Washington Post reported this list was prepared November
2006 by Mike Elston, who was the chief of staff of then
outgoing Deputy Attorney General McNulty. Why do you think Mr.
Elston put you on that list?
Mr. Brownlee. Well, Mr. Chairman, first of all, thank you
for allowing me to be here today and to testify.
Chairman Leahy. I am glad you are here, because as I told
you before we started, as a prosecutor you have probably the
best job in America. Go ahead.
Mr. Brownlee. Thank you, sir. I do not have specific
knowledge of exactly why Mr. Elston placed me on that list. No
one has come forward and told me. However, when I learned that
I had been placed on the list--Mr. Elston is the one who
informed me on March 14th of this year--I became concerned
enough that I reported that event to the Justice Department
that very evening. And so although I do not have any conclusive
information as to why I was targeted for termination, I
certainly had concerns about it and reported that.
Chairman Leahy. Did you discuss it with Deputy Attorney
General McNulty?
Mr. Brownlee. I spoke to Mr. McNulty the following day, on
March 15th. I told him that my name had appeared on this list
by Mr. Elston in an e-mail dated November 1, 2006, that I was
concerned about it. And I outlined him the facts that I knew
concerning that. He assured me that Mr. Elston was a good man.
I had my own views of that.
Chairman Leahy. Had you ever been given any negative
evaluations by Mr. Elston or by anybody at the Department?
Mr. Brownlee. No, sir.
Chairman Leahy. I find this interesting because you have
such an interesting background that I was surprised you were on
there. I realize I overlooked giving you time for an opening
statement, which I will. I was just going to ask you two other
questions, and I will stop with that.
In your written testimony, you say you began your
investigation of Purdue's activities surrounding OxyContin in
the fall of 2001.
Mr. Brownlee. That is correct.
Chairman Leahy. You then spoke with officials at Main
Justice, including Mr. Comey, about the charges you were
considering. Were you given any direction or criticism or
pressure from anyone in the Justice Department with regard to
your investigation or your plea negotiations?
Mr. Brownlee. If I may split that into two answers, I spoke
to Mr. Comey in 2005 concerning an issue regarding our
application of the Thompson memo, which was in effect at the
time that we were investigating this case. Mr. Comey had
received information from defense counsel that the Western
District was not applying that pursuant to DOJ policy. So Mr.
Comey inquired. I felt the inquiry was serious enough that I
actually grabbed one of my--not grabbed, but one of my
prosecutors and I drove up to Washington from Roanoke and sat
down with Mr. Comey and laid out for him exactly what we had
done pursuant to Thompson, our methods for trying to acquire
the necessary records to do this investigation.
Once Mr. Comey heard my explanation, he said, ``Brownlee,
you are fine. Go back to Virginia and do your case.'' And we
did, and I never spoke to him about the matter--
Chairman Leahy. Did you ever get any pressure from anybody
else even after Mr. Comey left?
Mr. Brownlee. The only thing that ever occurred was from
Mr. Elston himself. On October 24, I believe, 2006, that is the
day that this plea was to expire. We had provided counsel for
the company on October 19th, I believe, the final Government
offer to settle this case or they would face other things. And
so that evening--we had received earlier that day authority
from the Justice Department to go ahead and either accept the
plea or charge the company. Mr. Elston, who I had only met on
one prior occasion, on August 3rd--so I had only known him less
than 90 days--contacted me and was inquiring about the case. He
told me he had received a phone call from one of the defense
lawyers about the case and that that counsel had once again
said that we were moving too quickly, that they needed more
time, those kinds of things. And through his questioning of me,
I sensed that he was inquiring almost on their behalf.
I asked him if he was calling on behalf of the Deputy
Attorney General, and I was at home at this time. He told me he
was not. Once I learned that he was not speaking on behalf of
Mr. McNulty, based on the fact he had never attended any
substantive briefings and he was one that I did not feel
understood the case, I simply just kind of dismissed him and
told him that I had authority from Mrs. Fisher to proceed
forward and we were going to do just that and he needed to back
out of the way of the case. Ultimately, he complied with that,
and the company accepted the plea that evening.
Chairman Leahy. Thank you. And please feel free to go ahead
and give your opening statement. I apologize. Sometimes I
forget the procedure here, being new in this job.
Go ahead and give your opening statement, Mr. Brownlee.
STATEMENT OF JOHN L. BROWNLEE, UNITED STATES ATTORNEY, WESTERN
DISTRICT OF VIRGINIA, ROANOKE, VIRGINIA
Mr. Brownlee. Chairman Leahy, Senator Specter, and members
of the Committee, thank you for holding this hearing and
allowing me the opportunity to testify.
During the past 5 years, I led a team of career prosecutors
from my office and the Department of Justice, as well as State
and Federal investigators that conducted a sweeping
investigation of the manufacturer and distributor of the
painkiller OxyContin. Bringing this company and its executives
to justice was a difficult and important challenge, and I am
grateful for the hard work of the law enforcement professionals
upon whom these convictions rest. They represent the very best
of our Nation's law enforcement, and I am honored to serve with
them.
According to the evidence, Purdue began using focus groups
of primary care physicians in 1995 to determine whether such
physicians would be willing to prescribe OxyContin for patients
with non-cancer pain. These focus groups showed that what
doctors wanted was a long-lasting pain reliever that was less
addictive and less subject to abuse and diversion. Purdue
understood that the company that marketed and sold that drug
would dominate the pain management market. And that is exactly
what Purdue set out to do.
Despite knowing that OxyContin had an abuse potential
similar to that of morphine and was at least as addictive as
other pain medications on the market, in January 1996, Purdue
began marketing OxyContin as less addictive, less subject to
abuse and diversion, and less likely to cause tolerance and
withdrawal than other pain medications.
Due in part to Purdue's aggressive and misleading marketing
campaign, prescriptions for OxyContin skyrocketed, increasing
from approximately 300,000 in 1996 to nearly 6 million in 2001.
As OxyContin became more available, its abuse and diversion
increased, and this increase had a devastating effect on many
communities throughout Virginia and America.
On May 10, 2007, Purdue pleaded guilty to a felony charge
of illegally misbranding OxyContin in an effort to mislead and
defraud physicians and agreed to pay $600 million, an amount
that represented approximately 90 percent of the profits for
the sale of OxyContin during the time period of the offense.
Purdue also was required to subject itself to independent
monitoring.
In addition, Purdue's President Michael Friedman General
Counsel Howard Udell, and former Chief Medical Officer Paul
Goldenheim pled guilty to a misdemeanor charge of misbranding
OxyContin. These defendants were placed on supervised probation
for 3 years, ordered to perform 400 hours of community service,
and collectively pay $34.5 million in criminal fines.
Like other high-profile prosecutions, this case has not
been free of controversy. It has been suggested that my office
attempted to demonize OxyContin and that our decision to charge
the executives was ``a regrettable choice of prosecutorial
discretion.'' On the other hand, our decision not to seek
active incarceration also has been questioned.
After studying this case and the evidence carefully, I am
confident that the facts and law compelled our decision to
prosecute and sentence this company and its executives in
precisely the manner in which we did. The three executives pled
guilty to a strict liability misdemeanor offense based on the
fact that they were the responsible corporate officers of this
pharmaceutical company. This misdemeanor charge required no
proof of intent or actual knowledge of the violations to
establish their guilt.
The intent of the statute is to impose the highest standard
of care on certain corporate officials. The three defendants
had no prior criminal records, and the Sentencing Guideline
range for each defendant was 0 to 6 months. Under these
circumstances, I decided, and the court has agreed, that prison
sentences were not necessary to adequately punish these
defendants.
Convictions of the corporate officials will have
significant consequences. Each defendant will bear the stigma
of being a convicted criminal. These convictions also will send
a strong warning to executives of other pharmaceutical
companies that they, too, will be expected to exercise the
highest standard of care.
During the last several years, I have spoken to many people
who have been harmed or who have had a loved one harmed by
OxyContin--people like Marianne Skolek, whose daughter Jill
died from OxyContin and whose grandson, Brian, will now grow up
without his Mom. My belief is that these convictions have
advanced the cause of justice and I hope offer some measure of
closure for those who have suffered. These convictions have
confirmed what many believed for a long time: that Purdue's
marketing of OxyContin was deceptive and criminal.
It is important to note that most of the people never
claimed that Purdue was solely responsible for their loved
one's death. They just wanted Purdue to tell the truth about
the drug. The investigators and prosecutors who built this case
have brought that truth to light.
On April 1, 1940, Attorney General Robert Jackson spoke to
a group of United States Attorneys who had assembled in the
Great Hall at Main Justice. The future Supreme Court Justice
reminded those Federal prosecutors of their ethical and legal
duties in pursuing justice, and I quote: ``What every
prosecutor is practically required to do is to select the cases
for prosecution and to select those in which the offense is the
most flagrant, the public harm the greatest, and the proof the
most certain.''
I am confident that our prosecution of Purdue and its
executives and the sanctions imposed are consistent with
Department policies and Robert Jackson's mandate for justice.
I thank the Committee for allowing me to appear before you
today, and I would be pleased to answer your questions. Thank
you, sir.
[The prepared statement of Mr. Brownlee appears as a
submission for the record.]
Chairman Leahy. Well, thank you very much, Mr. Brownlee,
and I must state that I am very pleased to have you here, as I
said to you not only publicly but privately before.
I also should note I appreciate your duties in the Judge
Advocates Corps in the Army Reserve.
Mr. Brownlee. Thank you, sir.
Chairman Leahy. it is probably a little bit different than
your days as a paratrooper.
Mr. Brownlee. Yes, sir.
Chairman Leahy. And some days that may look like it is more
enjoyable.
Mr. Brownlee. Some days jumping out of the plane looks
pretty good, Senator. Thank you.
Chairman Leahy. I have done it once with the Golden
Knights, and I would do it again in a second. And I hope my
wife did not hear me say that because there would be probably a
vote on that.
I turn the gavel over to Senator Specter.
Senator Specter. [Presiding.] Thank you very much, Mr.
Chairman.
Mr. Brownlee, the company pled to a felony offense,
including an intent to mislead.
Mr. Brownlee. That is correct.
Senator Specter. Chief Judge Jones said, ``In the absence
of legal proof by the Government that the individual defendants
had knowledge of the wrongdoing charged or participated in it,
I do not think prison appropriate.''
Didn't the Government establish the underlying facts of the
guilty plea that there was intent to mislead known to the
individual defendants?
Mr. Brownlee. The answer is no, sir. The way we built this
case was through--in December of 2002, we served an
administrative health care subpoena on the company, a multi-
page document requesting records concerning the marketing of
OxyContin. Once we got those records, conducted hundreds of
interviews--these were millions of documents. We put them in a
data base, and the investigators and prosecutors, through word
search programs, went through those records and built a case
against the company.
It was almost putting together a puzzle. It was a piece
from a training manual. It was a piece from a call note.
Senator Specter. You ended up with an indictment that the
corporation and the individual defendants--a corporation does
not act by itself. A corporation acts through individuals, who
become individual defendants--that they had an intent to
mislead.
Mr. Brownlee. That is correct.
Senator Specter. And that resulted in, caused a great many
deaths.
Mr. Brownlee. Yes, sir.
Senator Specter. Well, that being so, wasn't there legal
proof that the individual defendants knew, since they intended
to mislead, knew what they were doing?
Mr. Brownlee. Well, the evidence that we submitted to the
court under the Agreed Statement of Facts did not include that,
and I want to be very careful, Senator Specter, on how I speak
concerning facts. All of these--much of these facts are
protected under Rule 6(e). This was a grand jury--
Senator Specter. It was not presented to the court. Does
that mean you did not have the facts? You did make a charge of
intent to mislead?
Mr. Brownlee. We did as to the corporate entity. This was a
corporate culture put together by many people.
Senator Specter. Well, I understand that. But the
corporation does not act by itself. It is inanimate. It acts
through people. So are you saying you could not identify the
people?
Mr. Brownlee. I think it is fair to say that when we looked
at the proof as to the corporate entity and we looked at the
proof as to particular individuals, that proof tested out
differently. As you well know, a corporation can be held
criminally responsible for the acts of its agents. For
instance, if a sales representative in another--
Senator Specter. I understand that. It could only be held
liable for the acts of its agents. That is the way it is
liable. And it can only be held liable for intent to mislead if
its agents intended to mislead.
Mr. Brownlee. Yes, sir.
Senator Specter. But once you have agents who intend to
mislead, you have the requisite proof to charge them with
wrongdoing.
Mr. Brownlee. Right.
Senator Specter. Which the judge said he did not have.
There is a total disconnect. Either you have a basis for saying
that there is an intent to mislead or you do not. And if you
have a basis for saying there is an intent to mislead, it is
because individuals acted in a way which led you to that
conclusion. And that being so, I do not see how you can have a
conclusion that the individuals were not wrongdoers who
deserved jail.
Mr. Brownlee. Well, Senator Specter, I think that the way
it boils down is that--I mean, the premise, I believe, is
correct, but when prosecutors and investigators look at
particular evidence as to a particular individual, the outcome
may very well be different.
For instance, in the example, let's say that that sales rep
did go to a physician and provide misleading information about
the product. There may be a sense, well, maybe you can
prosecute that particular individual based on that statement.
But then you look behind it and the defense would be, well,
wait a minute, I was trained that way and look at the training
manual. It has a graph in there that tells me this. And then
you--
Senator Specter. If they were trained that way, they did
not intend to mislead. Unless they knew that they were
misleading, they did not intend to mislead.
Mr. Brownlee. Exactly.
Senator Specter. Once you have them intending to mislead,
you have them engaged in conduct which merits jail.
Mr. Brownlee. Well, I think that the Senator is correct in
the sense that under that scenario, that individual would not--
we could not prove that that individual had the intent to
mislead. But as a corporate entity--
Senator Specter. Well, could you prove that any individual
had the intent to mislead?
Mr. Brownlee. We did not charge any individuals with the
intent to mislead.
Senator Specter. I understand you did not charge them. That
was not my question.
Mr. Brownlee. Yes, sir.
Senator Specter. My question was: Couldn't you prove that
some individual had an intent to mislead?
Mr. Brownlee. The evidence in this case was reviewed by
career prosecutors and investigators, and it was their
judgment--and I agree with them--that under the evidence in
this case, that the charging decisions, the felony for the
company and the strict liability misdemeanors for the
executives, were the appropriate charging decisions.
I must tell you, this case, no one wanted to bring these
defendants to justice more than the Western District of
Virginia. We initiated this in 2001. We spent 4 years going
through millions of records, conducting hundreds of interviews.
And this is the evidence of the case. And the career
prosecutors who have gone through this have asked themselves--
we asked ourselves the very questions you are asking me
practically every day for years about this case. We are bound
by the policies of the Department. The Ashcroft memo says you
must charge the most serious, readily provable charge that the
prosecutor has a good-faith belief that he or she can prevail
at court, which means a lawyer would have to stand up and prove
beyond a reasonable doubt to a unanimous verdict that a
particular individual had the specific intent to mislead. And
after reviewing this evidence, the charges that we came up with
were the appropriate charges under this evidence, with this
evidence.
Senator Specter. Well, the red light went on in our last
exchange, and I believe in observing the time limits
meticulously because I am asking everybody else to. But I do
not agree with you. The memo, the famous Thompson memo, Deputy
Attorney General Larry Thompson, ``Prosecution of a corporation
is not a substitute for the prosecution of criminally culpable
individuals within or without the corporation.'' And where you
have a basis for saying that there was an intent to mislead by
an individual, that is enough.
I respect your professionalism and I respect your judgment,
but speaking from an oversight capacity, I disagree.
Mr. Brownlee. Yes, sir.
Senator Specter. Senator Cardin?
Senator Cardin. Thank you very much, Mr. Chairman.
Mr. Brownlee, welcome to the Committee.
Mr. Brownlee. Thank you, Senator.
Senator Cardin. You are in a difficult position. It does
not look like you can win on either side on this issue. But I
first want to compliment you for bringing this case, for
challenging the corporate structure and doing a professional
investigation, which was extremely difficult to establish a
case of criminal conduct and then presenting it in a way that
you could succeed in court. It is challenging, and there are a
lot easier cases that you could have worked on, but you chose
an extremely difficult case. And I think it will have a major
impact on corporate conduct in our country.
Mr. Brownlee. Yes, sir.
Senator Cardin. Now, having said that, I think the point
that Senator Specter is raising is a legitimate point. When we
saw corporate greed hurt shareholders and employees, the
Congress changed its laws. Sarbanes-Oxley was passed. And we
changed the attitude that it is all right for corporations and
businesses to do whatever they wanted to do, that Congress
would take a more aggressive role.
I am just wondering whether we have a similar problem here.
I think the point that Senator Specter raised about a company
that is guilty of intentional conduct, misrepresenting
information that leads to consumers being put at risk and
losing their lives, that type of criminal conduct is actionable
by more than just fines. And, yes, it is extremely difficult to
be able to prove the actions of the agents, but somebody in
this company is responsible for intentionally taking action to
put the public at risk and cost people their lives.
So I am just wondering whether there is a need for change
of law or other types of tools that can be made available,
because I do think there are dual standards in America in our
criminal justice system, that if you happen to be guilty of
traditional type crimes, we would not think twice about letting
you ought of jail. You are going to go to jail. But if you have
a sophisticated network in which people are killed, you can
avoid jail time. To me, that is something that is unacceptable
in our system, and we need to look for how we change policy.
I want to thank Senator Coburn for his point because I
think there is responsibility beyond just the pharmaceutical
company here. People in the medical community who perhaps look
for easy ways to deal with a problem and do not supervise
properly or find out the medical history of an individual in
prescribing certain medications are also at least negligent, if
not further than negligent.
So I think this case brings up the need for further review
by perhaps Congress and by prosecutors as to whether we cannot
have a more effective way to get the message out that our
system of justice is going to be equally applied, and people
who intentionally bring harm to other people are going to pay
the consequences and not just the fine.
Mr. Brownlee. Thank you, Senator.
Senator Cardin. That is more of a statement, I guess, than
a question, but I really do want to come back to the point that
this was not an easy case, and I admire your willingness to
take this on. And I hope that the questioning you hear today is
not interpreted as challenging the manner in which you
proceeded, but we need to learn from this experience to make
sure that those that are responsible for criminal conduct are
held accountable in our system.
Thank you, Mr. Chairman.
Senator Specter. Thank you, Senator Cardin.
Senator Coburn?
Senator Coburn. Thank you.
Mr. Brownlee, I too want to compliment you for your
service, one. It is extremely frustrating to be a physician in
this country today and see all the problems we have in terms of
access to care, lack of availability of drugs, drugs being used
inappropriately. So looking at the problem that you had, I do
not find any fault with what you did. But I have some questions
that I would just like to have answered for me.
As you looked at all this documentation, did you see a
systematic marketing plan in all areas of the country that was
designed to oversell this product and underrepresent it, its
risks?
Mr. Brownlee. I believe the evidence that was submitted to
the court established the fact that the company as a corporate
entity made a judgment that they were going to market this drug
in a way that--and told doctors essentially that the basic
premise is addicts would not like it. There was a graph that
they used.
Senator Coburn. But that was throughout the country? You
did not see different areas throughout--different areas of the
country where you saw more penetration and less penetration
where you saw somebody doing this to a greater extent than
other areas? And the question I asked you was: Was there a
marketing plan that you actually saw that said that this was an
intent to do this?
Mr. Brownlee. Again, I think the evidence that was
submitted certainly indicated that the company intentionally
marketed the drug that it would be less addictive, less subject
to abuse and diversion, and that was the evidence that has been
submitted to the court.
As far as all parts of the country, I mean, it was a
company that certainly marketed the drug in all areas of the
country, and so, yes, that marketing was for everyone.
Now, some sales reps push harder than others. Some sales
reps said different things. But you had a training manual that
had these graphs in it, and I believe that--and some of other
pieces of marketing that was company-wide. And so--
Senator Coburn. Well, if that is the case and these
executives were responsible for that marketing plan, why are
they not culpable along the lines that Senator Specter asked
you?
Mr. Brownlee. Well, I would say, first of all, that they
have been held accountable.
Senator Coburn. But in light of his question, in other
words, you did not feel like you had the proof to convince a
jury 100 percent that that was the case.
Mr. Brownlee. That is correct. We looked at this evidence
very carefully for a long period of time. It was our judgment
that the charges that we brought--the felony for the corporate
entity, the strict liability misdemeanor for the executives--
was sufficient--well, was appropriate under the evidence that
we had.
Senator Coburn. So let me ask you another question. Why
were the guys that were out doing this and violating what they
knew this said, which is the label, why weren't they
prosecuted?
Mr. Brownlee. I would answer that in two ways. First of
all, the proof as to a particular individual, as we reviewed
it, was difficult to establish beyond a reasonable doubt. As I
gave the example to Senator Specter, there were some good
defenses that because the corporation had training manuals,
they had marketing materials, they had videos in which they
were trained this way--
Senator Coburn. But, Mr. Brownlee, these are professional
sales representatives. The one thing they are taught everywhere
in the country is the label is what counts and you cannot go
beyond the label. They all know that. So whether they were
trained to do it or not, they are also trained you cannot go
beyond the label. So the question comes, if you do not have
proof that the individual sales reps were actually doing it and
you do not have proof that will convince a jury that the
executives were, how do you know they were?
Mr. Brownlee. Well, I think--
Senator Coburn. And I am not disputing your case. I have
said that. But how do you know they were?
Mr. Brownlee. Well, in this case they pled guilty so they
told us they were. So in that sense, they have admitted it. But
it is a valid question. How could we have established at trial
that this company committed a felony? It is my judgment if you
look at all the pieces of that puzzle and you put it together,
I would feel comfortable as a litigator standing in front of a
jury and making the point this was a corporate culture, this
was a company, look at the training manual, look at these call
notes, look at these statements here, and you put it together.
It may not equal individual culpability as to a particular
person, but as a whole, I felt comfortable arguing before a
jury that we had sufficient evidence to convict the corporate
entity.
This was a case where there was not that smoking gun, there
was not that ``Aha'' moment where we found the e-mail that had
the grand admission. It just was not that kind of case. It was
kind of a deliberate process. It is one of the reasons why it
took so long to build that kind of case.
Senator Coburn. You have become pretty familiar with this
drug, right?
Mr. Brownlee. I have never taken it, but I--
Senator Coburn. No, no. I am not accusing you of that.
[Laughter.]
Senator Coburn. Hopefully you will not ever have to take
it.
Mr. Brownlee. Yes, sir.
Senator Coburn. When taken properly, it is a very good
drug. The question I have for you is: If you had significant
pain problems today and your doctor offered you OxyContin
because that is the best way to treat it, would you be afraid
to take this drug?
Mr. Brownlee. Senator, it is hard to say what I would
personally do.
Senator Coburn. Well, let me rephrase it a different way
then. If I offered you three Lortab instead of an OxyContin 10,
would you take that?
Mr. Brownlee. Again, Senator, I have been very blessed, and
I am not sure what a Lortab does either.
Senator Coburn. It is oxycodone except it is not slow
release. So here is the point I am trying to make, is we are
talking about a drug that I personally have experience with as
a physician and hundreds of thousands of other physicians do,
too, that shows that it does a very good job. The problem is
the abuse potential of it.
One point I want to make clear in here is there is a great
value to this medicine for me as a practitioner and thousands
and thousands of other doctors.
Senator Specter. Senator Coburn, how much more time will
you need?
Senator Coburn. I will stop with that if we are coming back
again. Are we coming back again? I guess the point I want to
make is this is not about the drug. This is about the actions.
And I want to make sure we keep it separate because if we do to
all the other abuse potential drugs, all the other Class II
drugs, if, in fact, there is anything out there in terms of the
marketing what we have done here, I may be without the kind of
drugs that I need for patients in the future. So we need to
separate the issue.
Mr. Brownlee. Yes, sir.
Senator Coburn. This has value in terms of this drug does
have great value. It is also a very dangerous drug, and all
narcotics are highly susceptible to abuse.
Mr. Brownlee. If I may respond just on one issue, you are
absolutely correct, and we were very careful to build this
criminal case about the specific facts of the
misrepresentation, the misbranding, and that is what is in the
Agreed Statement of Facts, and that is what provides the
factual basis for the plea.
But I also believe, as I talked about in my press release
and press statement, and the court talked about in his order,
that there was significant harm caused by the misbranding of
the drug. So much of it got out there that it gave addicts and
those dependent and others the opportunity to abuse it.
And so you are absolutely right, sir, that when we are in
the courtroom conducting a Rule 11 colloquy, it is the facts
that support the plea. But as Chief Judge Jones noted in his
order, there was harm caused by this, and a lot of folks
suffered. And it is one of the reasons why we pursued it as we
did because of that harm.
Senator Coburn. Well, my only concern is we should have
been pursuing every physician who was writing a scrip for it
when it was not needed, and that is the defect on the side of
the Justice Department and the DEA. Doctors make millions of
dollars writing this drug when they should not be doing it, and
we are not putting them in jail, and they need to be in jail
for that because they are just as guilty as anybody in that
company who might have marketed it wrong.
Mr. Brownlee. I will say that my office--and I cannot speak
for the entire Department, but--and we have 23 Federal
prosecutors, so we are a pretty small shop. But we have taken
an aggressive stance against physicians as well. We have
prosecuted physicians. We recently convicted a physician out in
Nevada who was--I think he was an OB/GYN--who was prescribing
OxyContin to folks from southwest Virginia. They were actually
driving to Nevada and getting the scrips and coming back and
then selling them and taking them. So we reached out to Nevada
and convicted him.
Senator Specter. Thank you, Senator Coburn.
Senator Sessions?
Senator Sessions. Thank you. I don't know why I thought
about a case I prosecuted. It was a Fortune 500 case, a
defendant from a Fortune 500 company, and it was so
complicated. I had one of the best prosecutors in America
involved in it and had one of the best defense lawyers, several
great defense lawyers. And so we finally got a misdemeanor
charge on one of the guys, and he was a professional lawyer. He
said, well, we will tell you what you really want to know.
Large amounts of money going through a foreign consulate and
all kinds of things. It was of great interest to us. And he
pled and testified, and we convicted the top guys for perjury
and that sort of thing.
And we got to court, and the judge chewed me out. He
thought we had given too sweet a deal to the guy who pled
guilty to get the other guys. And we never would have had a
case. I mean, you have to work cases in difficult ways. It was
an intense effort.
But, first of all, with 24 assistants, you have a number of
those on civil matters, a number of those on training matters,
a number of those--so you do not have that many line
prosecutors, do you? It is a fairly small office compared to
the several hundred some of the big offices have.
Mr. Brownlee. We are fairly small. Of those 23, four are
civil, 19 handle criminal work over three staffed offices, and
then the U.S. Attorney.
Senator Sessions. You have three different offices.
Mr. Brownlee. Yes, Senator.
Senator Sessions. Well, were you personally involved in
this case? Did you work it?
Mr. Brownlee. From the very beginning to the end.
Senator Sessions. Well, that is unusual. A lot of the
prosecutors just sit upstairs and let the assistants do all the
work. So I congratulate you on that.
Are you aware of any U.S. Attorney in recent years that has
got a $600 million fine against a company?
Mr. Brownlee. Gosh, Senator, I am sure someone out there
has done better than me, but, again, I am not aware of that
this year.
Senator Sessions. That is one of the biggest fines I have
observed, and I think first I just want to say that to you.
Mr. Brownlee. Thank you, Senator.
Senator Sessions. First of all, you personally led this
case. It could have been prosecuted in any district in America,
I suppose. You stepped up, you led the fight, you really
crushed their defense ultimately, and I am sure with this much
at stake, they had some of the best lawyers in America involved
in defending the case. And you got pleas on two of the top CEOs
and a $600 million fine on the corporation. And 90 percent of
the profit off this drug--Senator Coburn makes a valid point.
It dawned on me a lot of this drug was legitimately sold. It is
not in and of itself inherently an evil drug. So you got 90
percent of the profit. That means you got far more than the
abused sales that occurred. I want to make that point.
Second, we created, Congress did at some point in its
history, a strict liability statute, and that means--I will
summarize it and see if it is correct--that you simply proved
that they ran the red light, that they violated the standards,
and you do not have to show any criminal intent. You are just
guilty. Is that correct?
Mr. Brownlee. That is correct. We just have to establish
that they were the responsible corporate officers of a
particular company that delivers products under the Food, Drug,
and Cosmetic Act.
Senator Sessions. But to convict them of a felony, you have
to have a specific criminal intent, and you had to prove it as
to each one of the persons you would individually charge. Is
that correct?
Mr. Brownlee. That is correct, Senator.
Senator Sessions. Now, with regard to prosecuting a
corporation, you can aggregate knowledge, can you not? In other
words, you can prove this officer knew this, this one knew
that, this one knew this, and as a whole the corporation was
acting unlawfully, and you can sue the corporation. It is not
an entity. It does not have the same constitutional rights that
individuals have.
Mr. Brownlee. That is correct. It would obviously have a
trial, if it went there, and have all its rights in many ways,
although I am not so sure they actually have grand jury
protection. I think that is still a debatable issue. But you do
aggregate or you do look at the actions of all the players, all
its agents, when assessing corporate liability. And that is
what we have done.
Senator Sessions. And whereas it may not be enough to prove
personal criminal intent, felony knowledge on an individual,
that information can be aggregated as proof that the
corporation as a whole had knowledge and the corporation can be
held liable.
Mr. Brownlee. That is correct.
Senator Sessions. And that is what you did on the
corporation.
Mr. Brownlee. That is what we have done on the corporation.
Senator Sessions. Now, to convict the officers of a
felony--and we have got civil libertarians on this Committee
that think you cannot prosecute terrorists, you know. They want
to give them every right in the world. But anybody that is a--I
should not say that. Let me withdraw that.
[Laughter.]
Senator Sessions. That is not a fair statement. We do have
a great deal of interest in seeing that even terrorists have a
fair shake and the law is properly applied.
But I guess what I am saying with regard now to those
individuals defendants, you have to prove to charge them with a
felony that they had specific knowledge of the standards that
were expected of them and that these standards were not being
adhered to and that they authorized them in some fashion. Is
that correct?
Mr. Brownlee. The Government would have had to establish
beyond a reasonable doubt that whichever particular individual
you charged had the intent, showed the intent to defraud or
mislead.
Senator Specter. Senator Sessions, how much more time will
you require?
Senator Sessions. I am about through.
So you felt you did not have that knowledge, that proof?
Mr. Brownlee. This prosecution team reviewed, as I stated,
millions of records, conducted hundreds of interviews, and the
charges that we brought were the charges we felt we could
establish and were the proper charges under DOJ policy.
Senator Sessions. Now, the judge in sentencing--
Senator Specter. Senator Sessions, how much more time do
you--
Senator Sessions. One minute. The judge in sentencing did
give more probation than you asked for, but he could have given
custody. All you could do was make a recommendation. If the
judge had felt a custody sentence was appropriate, he had every
right to impose the full 6 months in jail, did he not?
Mr. Brownlee. This was conducted under Rule 11 (c)(1)(C),
and the Government agreed not to seek active incarceration. The
judge could have rejected the plea agreement if he felt that
these sentences and the plea itself was inappropriate.
Senator Sessions. But he found that he did not think, based
on the facts there, that prison was appropriate.
Mr. Chairman, I do not dismiss your concerns, and maybe we
need to review the law also to see if it needs to be tightened
up. But I just feel like this fine young United States Attorney
committed several years of his life to this case and did
something nobody else had done: put an end to this OxyContin
abuse, which is an absolute national problem.
I thank you for having the hearing.
Senator Coburn. Mr. Chairman, I would just ask unanimous
consent--he is our Chairman today--that the full opinion of
Judge Jones and the court order be placed in the record.
Senator Specter. Without objection, it will be included.
Senator Coburn. And I would also note that there was no
pleading of guilty to knowing by the executives of this company
misbranding with intent to mislead.
Senator Specter. Mr. Brownlee, thank you very much for your
service.
Mr. Brownlee. Thank you.
Senator Specter. It is a tough job, but it is a very
rewarding job, and we appreciate what you are doing.
Mr. Brownlee. It is a honor. Thank you, Senator.
Senator Specter. I call the second panel now. Will you step
forward? Will you, ladies and gentlemen, stand please and raise
your right hands? Do you solemnly swear that the testimony you
will give before the Senate Judiciary Committee will be the
truth, the whole truth, and nothing but the truth, so help you
God?
Ms. Skolek. I do.
Mr. Khanna. I do.
Dr. Wolfe. I do.
Ms. Pagano. I do.
Mr. McCloskey. I do.
Dr. Campbell. I do.
Senator Specter. You may be seated.
We have a very limited amount of time, so I am going to ask
all of you to stay right within the time limits, and we begin
with Ms. Marianne Skolek, who began looking into Purdue Pharma
after the death of her daughter, who took OxyContin. Thank you
for joining us, Ms. Skolek, and the floor is yours.
STATEMENT OF MARIANNE SKOLEK, LPN, MYRTLE BEACH, SOUTH CAROLINA
Ms. Skolek. Thank you, Senator Specter. My name is Marianne
Skolek. I had a beautiful 29-year-old daughter named Jill. She
had the misfortune of being prescribed OxyContin in January
2002 and was killed on April 29, 2002. Jill left behind her
son, Brian, who was 6 years old at the time of his mom's death.
Brian is with me in the Senate today.
Why did a $9 billion privately held pharmaceutical
corporation take the life of my precious daughter? My work
against Purdue Pharma for the past 5 years initially focused on
J. David Haddox, dentist turned psychiatrist and senior medical
director of Purdue Pharma. I also focused on Robin Hogen,
former public relations spokesman for Purdue Pharma.
In 1996, the American Academy of Pain Medicine and the
American Pain Society issued a set of guidelines for the use of
opiates in the treatment of chronic pain. These guidelines are
referred to as a ``consensus statement.'' The statement leaning
toward a more liberal use of opiates was adopted just as the
marketing push for OxyContin began. This consensus statement
was produced by a task force, which was headed by J. David
Haddox, former president of the American Academy of Pain
Medicine, who was senior medical advisor for Purdue Pharma, the
maker of OxyContin. Haddox was quoted as saying that ``the
point was to gather consensus. If you are going to do this,
this is how it should be done.'' There was question as to
whether it was ethical for Haddox to be associated with a
pharmaceutical manufacturer to guide the formation of a
document that would play a key role in promoting the use of
products made by the company Purdue Pharma.
When OxyContin was introduced on the market, it was
intended for the treatment of cancer patients, and they were
losing the patent on MS Contin. At one point, in the greed and
sheer evil of Purdue Pharma, they intended to market OxyContin
to OB/GYN patients. I flooded the country with e-mails and
faxes to Attorney Generals and the media reporting that we had
had enough devastation in the country without addicting infants
to OxyContin. This marketing ploy was terminated by Purdue
Pharma.
Pain patients from various pain societies will speak of the
merits of OxyContin and their quality of life being restored
because of the drug. These pain societies throughout the
country are funded by Purdue Pharma. Let the pain patients not
a part of any funded pain society of Purdue Pharma speak about
the quality of life they have after becoming addicted to
OxyContin--and when their physicians refuse to renew
prescriptions for the drug and they go on the street to buy the
drug because they can't kick the habit of this less addictive
drug. Ask the FDA and the DEA why OxyContin is in such
plentiful supply on the streets all over the country.
Jill and thousands of victims of an out-of-control, greedy
pharmaceutical company headed by three convicted criminals
marketed OxyContin as less likely to be addictive and abused.
There are assertions that the only victims in the criminal
activities of Purdue Pharma were the physicians who were misled
by Purdue Pharma's sales representatives. The physicians, who
were used as pawns by Purdue Pharma, were not ingesting a
powerful narcotic that was being marketed as less likely to be
addictive or abused. The patients were ingesting OxyContin and
were becoming addicted and dying. If patients aren't victims of
Purdue Pharma's criminal activities, tell me what they should
be called.
The addiction and loss of lives because of OxyContin
continue to impact every State in the country every single day.
The far-reaching consequences of the criminal activity of
Purdue Pharma did not end in 2001 or 2002 as they would like it
to be believed. No one can turn the clock back. This has been
allowed to become a national crisis because there was no
conscience in the marketing of OxyContin; there was only greed.
We all hear on the news every day about individuals who
work for Government agencies or private industry who embezzle
funds. Purdue Pharma has been found criminally responsible for
marketing OxyContin which resulted in death and addiction. Is
it justice to have these convicted criminals--these monsters--
fined an amount of money that is very well afforded by them? Or
will the Senate send a message that because of the magnitude of
the crime committed, they deserve to be further investigated by
the Senate?
Anything that is imposed against these convicted criminals
will not give us back Jill, but I will guarantee that Purdue
Pharma will never forget the name Jill Skolek. When I began my
work at exposing these three convicted criminals and Haddox and
Hogen, I told Hogen that you messed with the wrong mother. And
they did because my work is not over.
I want to know why the FDA allowed OxyContin to cause such
destruction to the lives of scores of innocent victims. I want
to know why 12 warning letters were sent by the FDA to Purdue
Pharma about their marketing of OxyContin and to this day they
are not required to put ``highly addictive'' or ``addictive''
on the label of the drug. I want to know why the FDA deleted so
many of my e-mails about the marketing of OxyContin until this
last month. I want to know why Curtis Wright while employed by
the FDA played an intricate part--
Senator Specter. How much more time will you need?
Ms. Skolek. One more minute. In the approval of OxyContin
and then was hired by Purdue Pharma. I want to know why
Attorney General Blumenthal of Connecticut's Citizen Petition
which requests strengthened warnings for OxyContin is still
sitting at the FDA--without any action--since January 2004. I
want to know how Rudy Giuliani could be the ``big star'' hired
by Purdue Pharma to play down the abuse and diversion of
OxyContin and then get paid by the DEA for work performed for
them. I want to know why the Sackler family has not been held
accountable for their involvement.
Eventually Purdue Pharma will introduce another blockbuster
drug similar to OxyContin, as they did with Palladone.
Palladone was removed from the market after a couple of months.
My advice to Purdue Pharma is when you are ready to introduce
another drug such as OxyContin or Palladone, look behind you,
because I will be right there.
I will be working at having Howard Udell disbarred for his
criminal activities and Paul Goldenheim's medical license
revoked for what amounts to white-collar drug trafficking. I
will accomplish this--hopefully with the help of Attorney
General Blumenthal. Do not doubt me at not being successful at
achieving this.
Her name was Jill Carol Skolek. She did not deserve to be
prescribed OxyContin and die because of the criminal activities
of individuals of Purdue Pharma. Please give my family justice
and investigate the criminal activity of Purdue Pharma.
Thank you, Senators, for giving me the opportunity to speak
for thousands of victims of an out-of-control pharmaceutical
corporation.
[The prepared statement of Ms. Skolek appears as a
submission for the record.]
Senator Specter. Thank you very much for your testimony,
Ms. Skolek. I am very sorry about your daughter.
Ms. Skolek. Thank you very much.
Senator Specter. This Committee and the Senate has no
authority, no power, once the case is concluded. It is what we
call res judicata, double jeopardy. But there are important
principles, which is the reason we are proceeding with this
hearing. Thank you.
Ms. Skolek. Thank you.
Senator Specter. We now turn to Professor Khanna, S.J.D.,
from Harvard Law School, Professor of Law at the University of
Michigan.
Thank you for joining us, Professor Khanna, and the next 5
minutes are yours.
STATEMENT OF VIKRAMADITYA KHANNA, PROFESSOR OF LAW, UNIVERSITY
OF MICHIGAN LAW SCHOOL, ANN ARBOR, MICHIGAN
Mr. Khanna. Thank you, Chairman Specter, and thank you very
much for inviting me to testify today. I will focus my comments
today on basically two questions.
The first is: Are criminal sanctions on executives
something we should consider when executives knowingly
introduce defective and dangerous products into the market? And
my short response to that question is yes, with the
qualification that we should try to exhaust the deterrent
effect of civil penalties first.
The second question I will address briefly is: If we do
decide to go forward with criminal sanctions on executives,
then what safeguards should we begin to think about putting in
place to help reduce the cost of criminal--
Senator Specter. Professor Khanna, pull the microphone a
little closer to you.
Mr. Khanna. Sorry. What sort of safeguards should we bring
into place to help reduce the cost of criminal liability on
executives? And my response here is that a well-defined and -
implemented mental state requirement, such as a knowledge
requirement, would be ideal with good examples of what
satisfies this particular mental state requirement. Also, I
would suggest some adjustments to the liability that
corporations bear that I will hopefully be able to discuss in
the next few moments.
Turning to the first point, whether a case can be made for
imposing criminal liability on executives, I would say that
yes, there can be a case made for that, but before doing so,
one should try to exhaust the deterrent effect of civil
penalties. The reason I sort of mention this is that in this
area we frequently rely more on corporate civil liability
rather than direct liability on executives. The reason for this
usually is that executives do not have the assets to pay for
the large amounts of harm that might be caused through the
corporate products they are selling. If they do not have the
assets to pay for it, their incentives to sort of take
appropriate care are somewhat less.
The corporation, of course, has more assets, and it can
also monitor its employees, so in some respects we deputize the
corporation to monitor what its employees are doing to prevent
them from engaging in harmful activity.
Of course, there are some kinds of harms that are so large,
such as drugs that induce death or serious injury, that
sanctions on the corporation will not be sufficient. They may
not also have the assets to pay for all the harm caused. In
those cases, we may go one step further and decide to impose
liability on executives, for example, criminal sanctions.
Senator Specter. Were the sanctions sufficient in this
case?
Mr. Khanna. Well, clearly, when the harm caused is death
and serious injury, it is quite likely that most corporate
assets will not be sufficient to pay for the harm caused,
especially given the numbers that are suggested here. I am not
familiar with all the people who have been injured and died
from using OxyContin, but if the numbers are as suggested in
the news reports, then we are in that range.
Moving sort of quickly on to talking a little bit about
safeguards, if we decide to go forward with criminal liability,
my primary concerns with imposing criminal liability are
largely the effects they are likely to have on who decide to
become executives at firms that produce these sort of high-risk
products. I can imagine a lot of good people, good,
conscientious, careful people, who might become a little
reluctant to take on the position of an executive at a firm
that is producing high-risk products because of the fear of
criminal liability. The primary concern that comes to me from
that is that if the good, conscientious, and careful people
refuse to be executives of these firms, then who do become the
executives of these firms? Perhaps people not so careful, not
so conscientious may be a little bit more tolerant of risk.
That might lead to more dangerous products being marketed and
in commerce in the U.S.
One way to address that particular concern, of course, is
to have a high mental state requirement; that is, to only
target liability to those people who were knowingly involved in
marketing dangerous products or defective products to the U.S.
public.
Of course, if you have a nice high mental state requirement
like knowledge, one additional concern is raised, which is, if
it is very hard to prove or difficult to prove that executives
knew about a particular product's defectiveness or
dangerousness, then many executives might find it in their
interest not to learn much about what are the safety risks of
their products. It may prove to them, at least in their mind,
to be a safer course to follow to not know much; that is, to
have their head in the sand, essentially.
Senator Specter. A corporate executive deliberately decides
not to know much, does that expose him to some liability for
failing to do his duty?
Mr. Khanna. It does under the willful blindness standard.
The only difficulty is that that is a rather difficult standard
to prove.
Senator Specter. They are all hard to prove.
Mr. Khanna. They are all hard to prove. That is true. But
it raises the same similar concern that if you have a mental
state requirement that is uncertain and difficult to prove,
then the careful people will probably be a little bit reluctant
to take on a position that exposes them to that kind of
uncertainty, especially when the consequences are spending time
in jail.
But there are ways to address the--
Senator Specter. How much more time will you need?
Mr. Khanna. Probably about 1 minute, if that is OK.
Very briefly, there is a way to address the concern that
executives may stick their heads in the sand, which is to
impose liability directly on the corporation in addition to
liability on the executive. And that may induce a corporation
to put in place measures to gather information about product
risk. Once the corporation has measures in place, it is very
difficult for executives to claim that they did not know what
was going on when reports are passing by their table on a
regular basis about product risk.
With that, I will conclude my testimony, and I thank the
Committee for allowing me to testify here today. Thank you.
[The prepared statement of Mr. Khanna appears as a
submission for the record.]
Senator Specter. Thank you very much, Professor Khanna.
We now turn to Dr. Sidney Wolf, Director of Public
Citizen's Health Research, adjunct professor of medicine at
Case Western Reserve University. Thank you very much for
joining us today, Dr. Wolfe, and we look forward to your
testimony.
STATEMENT OF SIDNEY M. WOLFE, M.D., DIRECTOR, HEALTH RESEARCH
GROUP OF PUBLIC CITIZEN, WASHINGTON, D.C.
Dr. Wolfe. Thank you, Senator Specter. I will discuss three
issues that have arisen from the highly touted prosecution by
the Justice Department of the Purdue Frederick Corporation for
``misbranding Oxycontin with the intent to defraud and mislead
the public.'' The issues highlight the double standard in this
country for prosecuting corporations and individual corporate
officials whose intentional activities result in hundreds of
deaths, versus the much more stringent penalties imposed on
non-corporate individuals who serve long jail sentences for
activities resulting in a tiny fraction of the damage done by
such corporate criminal activity.
The first issue is the prosecution of Purdue and subsequent
financial penalties that were inexplicably and unacceptably
limited to a time period--1996 to 2001--ending well before the
company ceased engaging in illegally misbranding Oxycontin. The
evidence for this is that on January 17, 2003, the FDA sent
Purdue a warning letter concerning clearly illegal promotion of
OxyContin during late 2002, almost a year after the curtain
dropped on the period for which they were prosecuted. And the
nature of the violations then--again, after December 31, 2001--
was almost exactly the same as those in the earlier periods of
time.
The beginning of the letter, which was, interestingly, to
one of the three company officials who were convicted of
misdemeanors--Michael Friedman--is reproduced here, and I will
just read a couple sentences from it.
First, it states that this is clearly a violation of the
Food, Drug, and Cosmetic Act. ``Your advertisements thus
grossly overstate the safety profile of OxyContin by not
referring in the body of the advertisement to serious,
potentially fatal risks associated with OxyContin, thereby
potentially leading to prescribing of the product based on
inadequate consideration of the risk. In addition, your journal
advertisements fail to present in the body of the advertisement
critical information regarding limitations on indicated use,
thereby promoting OxyContin for a much broader range of
patients,'' and so on.
In addition to this, under the first point about the
limited period of time of the prosecutions, the ending period
of prosecution, there was a nonprosecution agreement signed by
the three individual corporate criminals and the company itself
and agreed to by the Justice Department that prevents any
further prosecution of the company or the three guilty
officials for any activities before May 10, 2007--and,
implicitly, after December 31, 2001, including the one illegal
activity I just cited. This nonprosecution agreement includes
the promise not to seek additional criminal penalties or
forfeiture actions during this period of time. And I include in
the testimony from their own statements the nature of this
nonprosecution agreement.
The second point is the criminal penalties paid by the
company, said to be 90 percent of their profits on Oxycontin,
were apparently limited to the 1996 to 2001 interval even
though much of the subsequent 2002 to 2006 sales and profits
were unequivocally derivative of the earlier--and subsequent--
illegal promotional activities.
I include a chart in here of the sales. The Justice
Department has stated the financial penalties of $634 million
that they were assessed was 90 percent of the profits, which
would mean that the profits during the interval ending in 2001
December were about $700 million. Aside from the obvious,
continuing impact of the illegal pre-December 2001 promotional
activities, as evidenced by the massive continued prescribing,
the peak years of sales were 2002, 2003, and 2004, after the
end of this period. The further illegal activity that the FDA
caught them at adds to the need for their having gone farther.
In an affidavit in this case signed by the IRS, they
themselves said that going up through September 2004, there
were $2.67 billion in profits, and there are more since then.
The standard for the Government forcing a company to disgorge
profits is that the money was obtained through illegal means.
The illegal promotional activities of Purdue in 2002 were
clearly successful in continuing the earlier illegal
activities, as evidenced by the peak year of sales being 2003.
The subsequent sharp decrease in sales, with 2006 sales being
only 37 percent of the peak sales year in 2003, confirms that
once, belatedly, illegal promotion was finally stopped, the
ill-gotten sales and profits dropped significantly.
And the final point, no company official is going to jail--
and this is what you have focused on, Senator Specter--because
there was no felony conviction of any company person, just of
the corporation itself, which cannot go to jail. U.S. Attorney
Brownlee has said that the many prosecutors ``spent years
culling through millions of documents, looking for the
evidence. And what they did is they were able to piece together
a corporate culture that allowed this product to be misbranded
with the intent to defraud and mislead.''
Senator Specter. Dr. Wolfe, how much more time will you
need?
Dr. Wolfe. A minute, at the most. Why was it that there
were no individual humans who carried out the deadly missions
of the ``corporate culture'' such as the admitted activities--
and I quote from their own statement: ``Purdue supervisors and
employees sponsored training that used graphs that exaggerated
the differences...'' and so on. They had caught people doing
illegal kinds of things, and yet these people were never
criminally prosecuted and put in jail. This is from their own
press statement.
Why is it that no individual who had engaged in
``misbranding OxyContin with the intent to defraud and mislead
the public'' could be found and sent to jail? In 2002, a
physician who recklessly dispensed prescriptions for OxyContin
was convicted and subsequent sentenced for his crime. James
Graves, M.D., former naval flight surgeon, was sentenced to 63
years in jail for manslaughter for patients overdosed on
OxyContin. He was imprisoned in Santa Rosa County Jail in
Milton, Florida, pending appeal. Other non-physicians who
illegally sold OxyContin have also received jail sentences.
Employees of Purdue orchestrated an illegal scheme to
promote the same drug--OxyContin--as being safer, more
effective, and less subject to abuse than it actually was, and
pushed--
Senator Specter. Dr. Wolfe, we are going to have to move on
now. Very limited time.
Dr. Wolfe. Just 10 more seconds, really. Two more sentences
to go. And pushed hundreds of millions of prescriptions for the
drug based on the false pretenses of their promotional
campaigns.
Why are there no manslaughter charges, no jail sentences,
and such relatively low amounts of financial penalties? Is it
perhaps because Purdue has the money to hire Rudy Giuliani and
the best white-collar criminal defense lawyers to minimize the
damage to itself and its executives? If this does not represent
a double standard of justice, what does?
Thank you.
[The prepared statement of Dr. Wolfe appears as a
submission for the record.]
Senator Specter. Thank you very much, Dr. Wolfe.
Our next witness is Police Officer Virginia Pagano from the
26th Police District in Philadelphia, DEA certificate for
outstanding contribution in the field of drug law enforcement.
Thank you for joining us, Officer Pagano, and we look
forward to your testimony.
STATEMENT OF VIRGINIA PAGANO, POLICE OFFICER, PHILADELPHIA
POLICE DEPARTMENT, NARCOTICS BUREAU, PHILADELPHIA, PENNSYLVANIA
Ms. Pagano. Thank you, Senator. Good afternoon to the
Senate Committee. I am honored to be here today to speak to you
on behalf of the Philadelphia Police Department. I will speak
to you today on the devastation caused by OxyContin on family,
friends, and the communities that we serve.
I have been a police officer in the city of Philadelphia
for 20 years, and my current assignment is with the
Philadelphia Police Department, Narcotics Bureau's Drug
Education Program entitled ``H.E.A.D.S.-U.P.'' The Heads-up
Program has joined together law enforcement, family members,
unfortunately, who have lost loved ones, and the recovery
community. The response to this program has been overwhelming.
Since its inception, the Heads-up Program has been viewed
by approximately 449,000 people at 3,032 different locations.
We have been across the State of Pennsylvania, New Jersey,
Delaware, Massachusetts, and Connecticut. The program for the
past 6 years has exposed me to a completely different aspect of
law enforcement: the education side. It is of the utmost
importance to educate not only the law enforcement officers
that I work with, but the general public so that they can
better understand the devastation that is caused by drug
addiction.
The abuse of OxyContin is a problem that we cannot arrest
our way out of. It will primarily require education, along with
treatment and enforcement. We must educate every child before
they pick up that first drug because after that, we are just
simply playing catch-up.
I am inspired every day to continue the Heads-up Program,
and I often listen to story after story of how addictive
OxyContin is. The story seems to stay the same, but the faces
continue to change. Whether black, white, Hispanic, or Asian,
no matter what religion or political party, OxyContin has
crossed all boundaries.
It seems to me that among our young people, ``prescription
drugs''--namely, OxyContin, which is one of the most commonly
abused by our teens--just sounds safe, and yet the progression
from Oxy to heroin is a very common one.
One young lady's story always comes to mind, and I tell
these stories day in and day out. She stated to me that she
started using Percocet at the age of 13. She couldn't get
Percocet one night, and someone suggested Oxy. Then one night
she didn't have enough money to get OxyContin, so she tried
heroin, and as she says, that is when her life changed forever.
At 18 years old, this young lady is now in treatment because of
one little pill. But so many more are not as fortunate.
The abuse numbers are chilling. OxyContin addiction has
increased dramatically over the past 10 years, by 300 percent
in the United States alone.
In 2006, this past year's abuse of OxyContin among eight
graders drastically doubled--increasing 100 percent over the
last 4 years. Fifty-six percent of our teens agreed that
prescription drugs are now easier to get than any illegal drug
on the street.
I could spend the next 5 hours talking about statistics--
300 percent, 100 percent, 56 percent. But today I would like to
concentrate on the number ``one.'' Over the past 6\1/2\ years I
have met countless families who have lost a son, a daughter, a
husband, or a mother, and what I know is 300 percent, 100
percent, 56 percent means nothing. The only thing that matters
is that ``one''--the ``one'' who is and will always be missing
from that family from OxyContin addiction or overdose.
Because of these addictions, we continue to meet family
after family who live every day thinking about what it would be
like if their loved ones were still here, always asking
themselves, ``Who would they be today? ''
The ``cost'' I believe you will never be able to measure.
The son who died from Oxy might have held the cure for cancer;
the daughter will never be able to walk down the aisle with her
father. A father who was selling OxyContin is sitting in
prison, and the mother who was originally prescribed the drug
because of her pain from a car accident is now addicted and can
no longer care for her children.
Too many people realize too late that OxyContin abuse could
lead to incredible losses--lost families, lost friends, lost
jobs, lost opportunities, and lost lives either to the lifelong
addictions or overdose.
The $634.5 million in fines and three executives who pled
guilty for ``misbranding'' the drug as a ``low-risk''
painkiller will never equal the ``one'' who has been lost to
these addictions or overdoses. For that ``one'' who has been
lost will affect a whole family, a whole community, a whole
generation.
There are many, many faces that have been entrusted to us
with the Heads-up Program, and my only hope is that somehow
``one'' story, ``one'' face will somehow save another--
Senator Specter. Officer Pagano, how much more time will
you need?
Ms. Pagano. Ten seconds.--from the pain and never-ending
heartache that comes with addiction, because dead is dead
whether it comes at the hands of illegal drugs or prescription
drugs like OxyContin.
When I hit the street tomorrow, I will tell you honestly,
the abuse is not over from Oxy, as the Senator said.
Thank you.
[The prepared statement of Ms. Pagano appears as a
submission for the record.]
Senator Specter. Thank you very much, Officer Pagano.
We now turn to Attorney Jay McCloskey, a very distinguished
record in the U.S. Attorney's Office in Maine, held the
position as Assistant for 13 years and then was the U.S.
Attorney for 8 years.
Thank you for coming in from Portland, where you now
practice law, to join us here. The floor is yours.
STATEMENT OF JAY P. MCCLOSKEY, FORMER UNITED STATES ATTORNEY,
DISTRICT OF MAINE, MCCLOSKEY, MINA, CUNNIFF & DILWORTH, LLC,
PORTLAND, MAINE
Mr. McCloskey. Thank you very much, Senator, and thank you
for allowing me to testify today. I served as the United States
Attorney, as you said, for the District of Maine from 1993 to
2001 and, prior to that, as an Assistant United States Attorney
in that office from 1980 to 1993. I was an active drug
prosecutor and prosecuted literally dozens upon dozens of cases
and individuals as an Assistant United States Attorney.
In late 1999 and early 2000, I became aware of a growing
problem in Maine of prescription drug abuse that included, but
was not limited to, OxyContin. That prompted me in February
2000 to send a letter to all Maine practicing physicians
warning them about the abuse. Shortly thereafter, in March
2000, I received a call from Purdue's medical director, asking
me to meet and discuss the problem, but I deferred his request.
At the time, law enforcement officials were just
discovering the extent of the opiate abuse problem, and I
didn't see what the manufacturer could provide in the way of
helping law enforcement.
However, as I got into the problem, I came to realize that
traditional law enforcement was not going to solve this problem
and really was not going to even make a dent. I also came to
realize that Purdue Pharma could actually help law enforcement
reach health care providers to whom law enforcement generally
did not have access.
In September of 2000 I organized a meeting attended by
Federal, State and local enforcement, and Purdue executives.
Rather than sending lower-level executives, Michael Friedman,
the company's CEO; Howard Udell, the chief legal officer; and
the Purdue medical director attended this meeting and pledged
to do whatever they could to help. Howard Udell specifically
said to me--and I remember this very distinctly--``We want to
do what is right.'' That is what he said to me directly as a
United States Attorney, and I remember those words. But I did
not give them much moment at that point. But as I watched what
Purdue did and what they tried to do, I recalled those words
later on.
I worked with Purdue Pharma as the United States Attorney
because I saw that the company wanted to stop the abuse and
diversion of drugs, and it was able to help law enforcement do
that. They allowed me and others in my office to make
unrestricted presentations to doctors about the dangers of
overprescribing. That was sort of the chief problem at the
time. It was doctors overprescribing, not realizing that there
were drug seekers in the office, and the only way to reach
large numbers was at these medical seminars.
Purdue offered to provide, at no cost, tamper-resistant
prescription pads. This was very helpful, and they helped
develop those, and they helped distribute those. They developed
brochures to send out to all Maine doctors, and I think across
the Nation, about the dangers of drug abuse. And they showed me
those brochures as United States Attorney and gave me an
opportunity to change some of the information in there as I saw
fit in terms of making doctors and pharmacists aware of the
problems. These were the sort of steps that Purdue took while I
was United States Attorney.
In April 2001, I told Purdue executives that drug agents in
Maine had discovered that OxyContin 160's were being sold on
the street. I told them that if OxyContin 160 was abused, it
could result in death almost immediately.
A couple of weeks later, one of the executives called me
and, without any prompting from me, said, ``We are going to
take that product off the market.'' I can tell you, Senator, at
the time--this was the early stages of the OxyContin problem--
that was very impressive, that a company offered to take a
legitimate product off the market. And there were people who
did not want that to happen, especially in the cancer
community.
After I left the Government in 2001, I continued to work
with Purdue as a consultant, and I counseled them and worked
with them to implement continuing programs to try to prevent
the abuse and diversion of OxyContin. In each and every
occasion, they took my recommendations. The executives saw that
it was carried out. And I was persuaded many, many times that
these executives wanted to do the right thing, as the chief
legal officer said. They wanted to stop the abuse and diversion
of OxyContin, and everything they did established that to my
satisfaction. They marked the drugs for law enforcement so they
could tell where they were coming from. They stopped the
distribution in Mexico when there was a problem with diversion
in Mexico. Everything you could ask a company to do in terms of
trying to stop illegal diversion, they did.
Now, I do not condone any of the misstatements by the sales
representatives of any of the marketing problems. But it
clearly did not reach to the higher levels of the organization.
I was involved for a couple of years in very much detail and
heard nothing about the marketing--
Senator Specter. Mr. McCloskey, how much more time will
you--
Mr. McCloskey. Another minute, Senator. The marketing
problems that have resulted in the criminal plea.
So I believe that this company did what any law enforcement
officer would hope that a company would do whose product was
being abused and diverted.
Thank you.
[The prepared statement of Mr. McCloskey appears as a
submission for the record.]
Senator Specter. Thank you very much, Mr. McCloskey.
Our final witness is Dr. James Campbell, Professor of
Neurosurgery at Johns Hopkins.
Thank you very much for coming down today, Dr. Campbell,
and we look forward to your testimony.
STATEMENT OF JAMES N. CAMPBELL, M.D., PROFESSOR OF
NEUROSURGERY, SCHOOL OF MEDICINE, JOHNS HOPKINS UNIVERSITY,
BALTIMORE, MARYLAND
Dr. Campbell. Thank you, Senator Specter. I am Professor of
Neurosurgery at the School of Medicine at the Johns Hopkins
University. I have dedicated my career, spanning 30 years, to
the mission of decreasing the suffering associated with pain.
My perspective also arises from my work with the American
Pain Foundation. The APF is the Nation's leading nonprofit
organization devoted exclusively to serving the needs of people
with pain. Purdue has contributed generously during the 10
years that the APF has been in existence.
Let me begin by just indicating once again that chronic
pain is a serious health problem that afflicts more than 50
million Americans. Untreated pain has serious consequences.
This is not a benign condition. It interferes with sleep, work,
family relations, and induces depression and anxiety. Patients
with chronic pain become demoralized, and some even commit
suicide.
OxyContin is an opioid, and it is important to know that
opioids continue to be the most effective class of medications
there is for treatment of serious pain.
OxyContin is a form of oxycodone, prepared in such a way
that release into the bloodstream occurs in a steady manner
over a 12-hour period of time. The FDA was correct when they
originally, in 1996, approved the statement in the OxyContin
package insert--that is, the label--which said, and I quote
from the package inset approved by the FDA: ``Delayed
absorption as provided by OxyContin tablets is believed to
reduce the abuse liability of the drug.''
The popularity of OxyContin among addicts stems from one
simple fact: When the addict crushes an OxyContin pill, more
oxycodone is available than when the addict crushes a typical
immediate-release oxycodone pill. That this simple difference
could be associated with a problem of enhanced abuse was not
anticipated when the drug came out. No one in industry, no one
in academia, and no one at the FDA anticipated the problems
with OxyContin.
OxyContin, as Senator Coburn pointed out in his comments,
was always designated as a Schedule II medication. This is the
strictest label for prescribed drugs. The Schedule II
designation means that the drug has significant addiction and
abuse risk. Every doctor knows this. I find it very unlikely
that any competent doctor would not understand this simple
fact. Whatever a sales representative might or might not say to
a doctor, the doctor is obligated to know what he is
prescribing.
The numbers of prescriptions of OxyContin, unlike what Dr.
Wolfe indicated, continue to climb, regardless of the adverse
publicity associated with this drug and regardless of what
clearly now are responsible marketing efforts. If criminal
misconduct and reckless promotion were the sole drivers of
OxyContin use, why would sales continue to increase after these
alleged practices stopped? The answer is that OxyContin is a
good pain drug. The drug sells itself because pain is in large
part an unmet medical problem in America, and Americans are
desperate to get relief of their pain.
My heart, Senator Specter, goes out to those who have had
family members that have suffered complications of OxyContin
therapy or, for that matter, any drug therapy. I would like to
point out that last year over 10,000 Americans lost their lives
because of problems with NSAIDs, that is, drugs like aspirin
and ibuprofen. I wish we had perfect drugs, and I hope for the
day when we can offer relief of pain with greater safety and
efficacy. It is important to note, however, that the risk of
OxyContin arises in large part from a deliberate and
intentional misuse of the drug. When taken as directed by the
physician, the risk of OxyContin is no greater than with any
other opioid.
I think you should know also that when the abuse problems
with OxyContin became clearly apparent, Purdue undertook many
programs to combat addiction. I identify in my written
statement six programs initiated by Purdue. I know of no other
company that sells opioids that has instituted as aggressive a
program to fight abuse and addiction.
In conclusion, we here should all acknowledge that many
thousands, if not millions, of patients have benefited and
continue to benefit from use of OxyContin. The majority of
patients and doctors use this medication responsibly. Abuse is
a major problem as well. Making the executives at Purdue out to
be criminals does not engage us in a proactive fight against
abuse; rather, casting Purdue and its leadership as criminals
sends a chilling message to industry: ``Develop drugs at your
own peril. If problems develop with the drugs you develop, you
may end up in jail.''
I think we can do better, Senator Specter. I think we can
send a proactive message, and that is that both pain treatment
and drug abuse are major problems in our society, and we need
academia, industry, and Government to work together to address
these critical problems.
Thank you.
[The prepared statement of Dr. Campbell appears as a
submission for the record.]
Senator Specter. Thank you very much, Dr. Campbell.
Well, I think there is a fair amount to be learned from the
hearing which we have had today. I cannot quite agree with you,
Dr. Campbell, about the lack of complicity of the
manufacturers. There at least appears to be substantial
evidence of misleading conduct on their part. They certainly
have defended the case. I understand the risks of litigation,
but there are serious, serious problems.
Senator Coburn may well be right when he talks about
doctors' culpability, and I would not let anybody off the hook,
and this need not be the last hearing on this subject with
respect to doctors who have not prescribed the proper recourse.
But there have been a lot of deaths, and to the extent that you
have misuse of the drugs, the manufacturer cannot prevent that.
There is no doubt about that. But there has to be an evenhanded
approach by the Department of Justice, and the U.S. Attorney
who appeared here is obviously an able man who approached this
in very good faith and in a very professional way. So I believe
that this kind of oversight is very important, and we have the
benefit of Dr. Coburn's medical expertise to provide an extra
dimension, which he does on quite a number of subjects.
Again, our regrets to you, Ms. Skolek.
As I said, I am past due on excusing myself, and Senator
Coburn is left in charge to keep the last questioning Senator
in tow.
Senator Coburn. I will. Thank you, Mr. Chairman.
First of all, I would like unanimous consent to put some
things in the record from the National Survey on Drug Use and
Health, which directly contradicts some of the testimony we
have heard today. OxyContin accounts for less than 7 percent in
2005 and less than 4 percent in 2006 of the opioid abuse.
Senator Specter. Senator Coburn, you are going to have to
persuade the substitute Chairman to give you consent on that
because I am leaving.
Senator Coburn. Well, I am the substitute Chairman so I
will grant such a thing.
I will also ask unanimous consent that the breakdown of
drugs of abuse from the National Survey on Drug Use and Health
be placed in the record.
Senator Specter. Senator Coburn, thank you for taking over
the balance of the hearing.
Senator Coburn. [Presiding.] I will be happy to. It will be
the first it has happened from the far right.
[Laughter.]
Senator Specter. I refer to you most often as the ``far
correct.''
Senator Coburn. ``Far correct,'' well, thank you. That is a
nice compliment.
I want to thank each of you for your testimony. You know,
what we have in front of us is we are struggling with problems
in our society. Lortab is a far greater problem out there than
OxyContin, and I think you would probably agree. You see it a
whole lot more. It is abused more. The problem is you cannot
kill yourself as easy with it. That is the problem.
We are struggling in our Nation and we are looking for
things, and oftentimes I have the feeling that maybe somebody
might have done something wrong, but maybe they did not. What
if there was no intent on this case? You know, we had testimony
there was not an organized marketing plan that was intended to
violate the standard. There was nothing from the FDA that ever
said they--there is no change in the label. The question is:
Are we going to, regardless of what happened, continue to have
medicines available for people that solve tons of problems? As
noted by Dr. Campbell, we did have over 40,000 people die last
year just from Motrin and Advil and aspirin and Aleve,
complications of it.
Every death is a tragedy, but we should not confuse good
medicines that are abused and ruin what can be great success
for individuals with serious pain. And my hope is with all the
people that are suffering grief from the consequences of this,
for all the doctors who have written a prescription when they
should not, for those of us who assume that chronic pain is not
as big a problem as it is--which we do every day. We fail to
listen properly to those people who are having that. To our law
enforcement who are struggling to try to control this thing, to
the real absence of the problem--and here is the real problem.
We do not have great drug treatment in this country, and
instead, we incarcerate people rather than put them into a drug
treatment center where we know two-thirds to three-quarters of
them will come out of that and never use drugs again, but yet
we incarcerate them.
We need to change the channel on how we do that. We need to
offer a helping hand to life back on people who are drug
addicted. And we know it will work if we will invest in it.
So to all of you that testified, I want to thank you for
making an effort to put forth your views. I would affirm that I
think this is a valuable drug in our armamentarium to help
people in this country, and until you can get us something
better, we ought to continue to use it.
I also agree with Senator Specter that we ought to look at
the responsibility of physicians in this country on Class II
drugs and do we need to change that. Do we need to restrict--as
a physician, I hate that word, ``restricting'' my ability to
practice medicine. But if my peers are not going to be
responsible in distributing and writing prescriptions for these
medicines, maybe we need to make them more responsible.
The drugs that are on the street, somebody wrote a
prescription for. They did not just get out there. They did get
them out of the warehouse. Somebody wrote a prescription.
I also am going to enter into the record a statement of
Howard Shapiro evaluating the propriety and adequacy of the
OxyContin criminal statement. That is at the request of an
absent Senator, and I thank each of you for being here, and the
hearing is adjourned.
[Whereupon, at 4:16 p.m., the Committee was adjourned.]
[Questions and answers and submissions for the record
follow.]
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