[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

                              ----------                              

                    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

                              ----------                              


                         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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