[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]



 
    TO DO NO HARM: STRATEGIES FOR PREVENTING PRESCRIPTION DRUG ABUSE

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

                                HEARING

                               before the

                   SUBCOMMITTEE ON CRIMINAL JUSTICE,
                    DRUG POLICY AND HUMAN RESOURCES

                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                               __________

                            FEBRUARY 9, 2004

                               __________

                           Serial No. 108-187

                               __________

       Printed for the use of the Committee on Government Reform


  Available via the World Wide Web: http://www.gpo.gov/congress/house
                      http://www.house.gov/reform
                     COMMITTEE ON GOVERNMENT REFORM

                     TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana                  HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut       TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana              CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California                 DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky                  DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia               JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania    WM. LACY CLAY, Missouri
CHRIS CANNON, Utah                   DIANE E. WATSON, California
ADAM H. PUTNAM, Florida              STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia          CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee       LINDA T. SANCHEZ, California
NATHAN DEAL, Georgia                 C.A. ``DUTCH'' RUPPERSBERGER, 
CANDICE S. MILLER, Michigan              Maryland
TIM MURPHY, Pennsylvania             ELEANOR HOLMES NORTON, District of 
MICHAEL R. TURNER, Ohio                  Columbia
JOHN R. CARTER, Texas                JIM COOPER, Tennessee
MARSHA BLACKBURN, Tennessee          ------ ------
------ ------                                    ------
------ ------                        BERNARD SANDERS, Vermont 
                                         (Independent)

                    Melissa Wojciak, Staff Director
       David Marin, Deputy Staff Director/Communications Director
                      Rob Borden, Parliamentarian
                       Teresa Austin, Chief Clerk
          Phil Barnett, Minority Chief of Staff/Chief Counsel

   Subcommittee on Criminal Justice, Drug Policy and Human Resources

                   MARK E. SOUDER, Indiana, Chairman
NATHAN DEAL, Georgia                 ELIJAH E. CUMMINGS, Maryland
JOHN M. McHUGH, New York             DANNY K. DAVIS, Illinois
JOHN L. MICA, Florida                WM. LACY CLAY, Missouri
DOUG OSE, California                 LINDA T. SANCHEZ, California
JO ANN DAVIS, Virginia               C.A. ``DUTCH'' RUPPERSBERGER, 
EDWARD L. SCHROCK, Virginia              Maryland
JOHN R. CARTER, Texas                ELEANOR HOLMES NORTON, District of 
MARSHA BLACKBURN, Tennessee              Columbia
                                     ------ ------

                               Ex Officio

TOM DAVIS, Virginia                  HENRY A. WAXMAN, California
                     J. Marc Wheat, Staff Director
          Nick Coleman, Professional Staff Member and Counsel
                         Nicole Garrett, Clerk
                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on February 9, 2004.................................     1
Statement of:
    Fernandez, William T., Director of Central Florida High 
      Intensity Drug Trafficking Area, Office of National Drug 
      Control Policy; Robert J. Meyer, M.D., Director, Office of 
      Drug Evaluation II, Center for Drug Evaluation and 
      Research, U.S. Food and Drug Administration; and Tom 
      Rafffanello, Special Agent in Charge, Miami Division, Drug 
      Enforcement Administration.................................     9
    McDonough, James R., director, Florida Office of Drug 
      Control; Dr. Stacy Berckes, M.D., board member, Lake Sumter 
      Medical Society; Jack E. Henningfield, Ph.D., Pinney 
      Associates, on behalf of Purdue Pharma; and Theresa Tolle, 
      R.Ph., president, Florida Pharmacy Association.............    88
    Pauzar, Frederick W., father; Douglas Davies, M.D., medical 
      director, Stewart-Marchman Center; Paul L. Doering, M.S., 
      distinguished service professor of pharmacy, University of 
      Florida; Karen O. Kaplan, M.P.H., SC.D., president and CEO, 
      Last Acts Partnership; and Chad D. Kollas, M.D., medical 
      director, palliative medicine, M.S. Anderson Cancer Center 
      Orlando....................................................   187
Letters, statements, etc., submitted for the record by:
    Berckes, Dr. Stacy, M.D., board member, Lake Sumter Medical 
      Society, prepared statement of.............................   106
    Davies, Douglas, M.D., medical director, Stewart-Marchman 
      Center, prepared statement of..............................   194
    Doering, Paul L., M.S., distinguished service professor of 
      pharmacy, University of Florida, prepared statement of.....   199
    Fernandez, William T., Director of Central Florida High 
      Intensity Drug Trafficking Area, Office of National Drug 
      Control Policy, prepared statement of......................    11
    Henningfield, Jack E., Ph.D., Pinney Associates, on behalf of 
      Purdue Pharma, prepared statement of.......................   110
    Kaplan, Karen O., M.P.H., SC.D., president and CEO, Last Acts 
      Partnership, prepared statement of.........................   205
    Kollas, Chad D., M.D., medical director, palliative medicine, 
      M.S. Anderson Cancer Center Orlando, prepared statement of.   212
    McDonough, James R., director, Florida Office of Drug 
      Control, prepared statement of.............................    91
    Meyer, Robert J., M.D., Director, Office of Drug Evaluation 
      II, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, prepared statement of.................    15
    Mica, Hon. John L., a Representative in Congress from the 
      State of Florida:
        Prepared statement of Jim Kragh..........................    47
        Prepared statement of Burt Saunders......................    78
    Pauzar, Frederick W., father, prepared statement of..........   190
    Rafffanello, Tom, Special Agent in Charge, Miami Division, 
      Drug Enforcement Administration, prepared statement of.....    37
    Tolle, Theresa, R.Ph., president, Florida Pharmacy 
      Association, prepared statement of.........................   163
    Weldon, Hon. Dave, a Representative in Congress from the 
      State of Florida, prepared statement of....................   231


    TO DO NO HARM: STRATEGIES FOR PREVENTING PRESCRIPTION DRUG ABUSE

                              ----------                              


                        MONDAY, FEBRUARY 9, 2004

                  House of Representatives,
 Subcommittee on Criminal Justice, Drug Policy and 
                                   Human Resources,
                            Committee on Government Reform,
                                                   Winter Park, FL.
    The subcommittee met, pursuant to notice, at 9:07 a.m., in 
the Winter Park City Hall, 401 Park Avenue South, Winter Park, 
FL, Hon. Mark Souder (chairman of the subcommittee) presiding.
    Present: Representatives Souder, Mica, Norwood and Keller.
    Staff present: Nick Coleman, professinal staff member and 
counsel; and Nicole Garrett, clerk.
    Mr. Souder. Good morning, and thank you all for coming. 
This hearing focuses on a very old and very widespread problem, 
the abuse of prescription drugs. Prescription drug abuse itself 
is nothing new, but recently a new generation of morphine-based 
pain killers has caused a wave of addiction in overdoses 
throughout the United States. The drug OxyContin has produced 
the greatest amount of publicity, but numerous similar drugs 
such as, Percocet, Percodan, and Tylox have also been abused.
    Prescription drug abuse presents special problems for the 
government, the medical community, and the pharmaceutical 
industry. On the one hand, these are powerful and dangerous 
drugs, with as great a capacity for addiction and abuse as 
heroin and cocaine. There are many ways for these drugs for to 
fall into the wrong hands. Supplies of the drugs can be stolen 
from pharmacies and manufacturers, and then sold on the black 
market. Doctors may intentionally or unintentionally over-
prescribe the drugs to patients leading to addiction and abuse. 
Or patients themselves may obtain illegal quantities of the 
drug by shopping for multiple prescriptions and filling them at 
multiple pharmacies.
    On the other hand, these drugs have legitimate medical 
uses, and may give the only possibility of relief for patients 
suffering from chronic pain. Many cancer patients for example, 
rely on OxyContin and similar drugs to combat crippling pain, 
while other individuals suffering from severe injuries may need 
similar treatment. Any regulatory plan must balance these 
completing concerns. Two Federal agencies are primarily 
responsible for the regulation of prescription drugs. The U.S. 
Food Administration and the Drug Enforcement Administration.
    The FDA has the job of testing new drugs, and specifying 
how the drug may be marketed, prescribed and used, while DEA is 
responsible for monitoring the distribution and prescription of 
these drugs to prevent their illegal use. In addition to 
investigating illegal trafficking of prescription drugs, DEA 
also, controls the licenses that every physician must have in 
order to prescribe controlled substances. FDA and DEA have been 
criticized both for being too lenient and for being too strict 
in the regulation of prescription drugs.
    Former addicts, relatives of those who have died of 
overdoses and many media commentators have argued that FDA has 
failed to safeguard the public from dangerous drugs by 
sufficiently regulating their marketing and distribution. These 
critics, some of whom it must be noted have filed lawsuits, 
have accused manufacturers of over-marketing pain killers and 
failing to warn doctors of the real risks of addiction and 
abuse.
    By contrast, some doctors, patients, and other advocates 
for pain treatment have accused DEA of carrying out a virtual 
war against physicians by aggressively prosecuting those who 
willfully over-prescribe pain killers. While the specific 
actions of FDA and DEA and the pharmaceutical companies may be 
debated, it is clear that the Federal Government needs to 
explore new approaches to these problems. Congress and the 
executive branch need to reexamine the approval and marketing 
process, and determine how best to monitor the distribution and 
state of pain killers.
    Several new proposals are already being debated. For 
example a number of States are exploring the concept of setting 
up computerized data bases that would track the sale and 
prescription of controlled substances to enable law enforcement 
officials to determine when a doctor is prescribing, a 
pharmacist is dispensing, or an individual is receiving 
suspiciously large amounts of a drug. Many States are also 
attempting to combat the illegal distribution of these drugs 
over the Internet, an issue that Government Reform Committee 
Chairman Tom Davis is working to address.
    Other proposals focus on what warnings pharmaceutical 
manufacturers are required to give doctors and patients in 
providing information on addiction and how to treat it.
    This hearing will allow the subcommittee to hear from 
governmental, medical, and other witnesses to testify about the 
cost of prescription drug abuse, the benefits afforded by those 
drugs, and how to best balance between these two.
    I first want to thank Congressman Mica for proposing this 
hearing, and for the assistance that he and his staff have 
provided in setting it up. Congressman Mica, was chairman of 
this subcommittee before myself, and both of us have been 
active on this committee since the Republicans took over 
Congress. In fact Congressman Mica, used to be, in his first 
term, a critic of this subcommittee for not focusing on drug 
abuse and when we took over Congress this committee changed 
from having I think maybe one hearing on the issue on illegal 
drug use to becoming the focal committee in Congress. Then, now 
Speaker Hastert, chaired the committee with Congressman Mica 
being a very active member, and then Congressman Mica chaired 
it, and it has been my honor to chair it since then. And he has 
been vigilant from the time he was a staffer for Senator 
Hawkins as I was for Senator Coats and we worked on these 
issues in 1989 and 1990, to coming over as we became the 
majority in the House and making sure we have both the best 
health care system in the United States, but also go after the 
illegal drugs in the United States. I appreciate his coming to 
me on the House floor saying we need to focus on this and I 
really would like you to do this in Florida, and for his 
leadership in the House on this issue.
    We also have been joined by two of my colleagues, 
Congressman Charlie Norwood who also came in with our class in 
1994 and we have been good friends for a long time, and 
Congressman Keller from Florida who is a more recent Member of 
Congress who we served on the Education Committee together, and 
have since moved over, and who has been another leader in 
Congress.
    We also welcome three witnesses who joined us to discuss 
the Federal Government's response to this problem. Mr. William 
T. Fernandez, Director of the Central Florida High Intensify 
Drug Trafficking Area or HIDTA, a program administrated by the 
White House Office of National Drug Control Policy; Dr. Robert 
J. Meyer, Director of the U.S. Food and Drug Administration's 
Office of Drug Evaluation at the Center for Drug Evaluation and 
Research; and Mr. Tom Raffanello, Special Agent in Charge of 
the Drug Enforcement Administration's Miami Office.
    We are also pleased to be joined by two representatives of 
the Florida State government who have taken a lead role in 
fighting against prescription drug abuse, Mr. James R. 
McDonough, director of the Florida Office of Drug Control; 
State Senator Bert Saunders, who has just called in and has had 
an emergency and cannot be here.
    We also welcome Dr. Stacy Berckes, Board member of the Lake 
Sumter Medical Society; Mr. Jack E, Henningfield, of Pinney 
Associates who is testifying on behalf of Purdue Pharma; Ms. 
Theresa Tolle, president of the Florida Pharmacy Association.
    We also, welcome several witnesses who can discuss the 
importance of these issues to patients and individuals. In 
particular, we welcome Mr. Frederick Pauzar, who lost a son to 
an OxyContin overdose, and who has taken a leadership role in 
addressing the problem of prescription drug abuse. We are 
especially pleased to be joined by a specialist in the 
treatment of prescription drug addiction, Dr. Douglas Davies, 
medical director of the Stewart-Marchman Center. We also, 
welcome Professor Paul L. Doering of the University of Florida 
College of Pharmacy; Ms. Karen O. Kaplan, president and CEO, of 
Last Acts Partnership, and Dr. Chad D. Kollas, medical director 
of the palliative medicine at M.D. Anderson Cancer Center of 
Orlando.
    We thank everyone for taking the time to join us this 
morning, look forward to your testimony, and now I would like 
to yield to my friend and colleague Mr. John Mica.
    Mr. Mica. Thank you, Mr. Chairman. I am pleased that the 
Subcommittee on Criminal Justice, Drug Policy and Human 
Resources has agreed to conduct this first oversight hearing on 
the problem that we face not only in our community and our 
State but also our Nation, the problem of misuse and abuse of 
certain prescription drugs, particular today we are going to 
focus on the problem of OxyContin abuse and misuse. I think 
this is a very important hearing, and I appreciate your 
responding to my request.
    I want to also thank and welcome Charlie Norwood, from 
Georgia. A gentleman from Georgia, he is a key player in this. 
Our committee is investigative and oversight. Dr. Norwood--and 
he has a medical background, a dentist--he serves on a 
committee that can actually move legislation forward and I know 
in my discussions with him last evening he is anticipating 
putting together some legislative fixes to this problem. He 
does so not just from a legislative standpoint, he is not an 
attorney, but he has been an expert in medical practice here in 
dentistry, so he knows a lot of what he is talking about, has a 
very great deal of experience that we can draw upon.
    And I am also, pleased that Rick Keller--there are four 
Members of Congress that share Winter Park. It is a great 
community to share, but I am pleased that he came out. He 
shares my concern about what is happening in our community, 
again across the State, and Nation with abuse of prescription 
medication, so this is an important area.
    I was sitting here thinking, as we convened the hearing, 
back to I think it was December 1980, Senator Paula Hawkins was 
sworn in this room in advance actually of her term. It was a 
prearranged swearing in so she could gain a little bit of 
seniority, and she really began some of the fight to address 
the problem of illegal narcotics, bring it the attention of the 
U.S. Senate, the Congress, the problems we had back in the 
1980's. At that time it was cocaine and other drugs.
    And so, it is ironic that we are back here.
    When I took over chairing this subcommittee--but before 
that when I was on the committee, Mr. Hastert--Mr. Souder 
served with and got to know the current Speaker very well in 
service. He was very dedicated to addressing the problem of 
illegal narcotics, and we conducted back in the late 1990's a 
hearing in Lake Mary on the problem of heroin addiction. I 
point that out because we continue to be challenged as a 
community, State, and Nation on the problem of illegal 
narcotics. Some of that now has shifted to abuse of 
prescription medication, and particular, again the focus of 
this hearing is OxyContin.
    For the record, Mr. Chairman, we did a little review of 
some of the statistics, back in 1999, we had in central Florida 
80 heroin deaths, and that was considered an epidemic. In 
2000--and actually we had zero according to the figures I have 
of OxyContin deaths, overdose or deaths from OxyContin. In 
2002, we had 68 deaths in central Florida. If we look at it 
statewide, in 1999, we had 198 heroin deaths, had zero that I 
have a record of for OxyContin. In 2002 we had 589 OxyContin 
deaths, as opposed to 326 statewide for heroin. So, if we had a 
serious problem or epidemic then, we certainly have a situation 
that deserves our attention as an oversight committee, today.
    Finally, I want to say that the purpose of this hearing is 
to find some positive solutions to deal not only with one 
particular drug, but any drugs, whether they are illegal or 
legal, find means and ways of keeping them out of the hands of 
people who abuse them, misuse them. In some cases we find they 
are stealing, robbing, pillaging to obtain those narcotics. It 
is our responsibility in Congress to make certain that we have 
adequate legislative and law enforcement and agency rules, 
regulations and laws, to deal with a problem of this magnitude. 
So, I am hopeful that this hearing will help us find some 
positive solutions.
    I look forward to my colleague, Mr. Norwood, Dr. Norwood's 
legislative proposal. I look forward to hearing the testimony 
today from, of course, members of the community who have been 
affected by the ravages of misuse of prescription medication. 
We look forward to hearing from some of the national experts, 
that have been assembled here in Winter Park. And I think that 
we will also, hear from our law enforcement folks who had to 
deal with some of the problems created by misuse, abuse, 
addiction to prescription medication.
    So, again I welcome Chairman Souder, I thank you, and again 
I hope we can have some positive results from this oversight 
hearing. I yield back.
    Mr. Souder. Thank you, I would now like to recognize my 
friend, Congressman Norwood. When we first ran in 1994, both of 
us, I as a small businessman, and he as a dentist, we never 
thought we were going to be Congressmen. And then we came in 
this big wave and all of a sudden over the years it has been 
developed that we are in the majority, and we not only have the 
Senate and the Presidency, and it is a whole lot different now 
actually with the responsibility of having to figure out how to 
do these things and work them out. But, it has been a great 
opportunity to work together and join our other colleagues, and 
it is great that you could be here today.
    Dr. Norwood. Thank you, Chairman Souder, for allowing me to 
join you today. As you know we have great interest in this 
subject in the Health and Environment Subcommittee out of the 
Commerce Committee, and I am grateful for the opportunity to 
listen and learn today.
    I also want to thank my host Mr. Mica, for the hospitality 
that he has shown me during this visit. I will tell you it is 
unusual for Georgians to say nice things about Floridians this 
close to football season, but I do appreciate the warm welcome 
and I have enjoyed being in your hometown.
    The use of drugs to relieve pain is a subject which I have 
had significant experience in my life. I have experienced it 
when I was in Vietnam treating wounded soldiers. I have 
experienced it as a practicing dentist for 25 years. I have 
experienced it with family and friends through difficulties 
they may have faced in life, and I have experience a little bit 
of it personally after a car wreck in 2000.
    I feel pretty strongly that we do not do a good enough job 
to alleviate pain when we can, and morally and ethically we 
should. I will say I think we are doing a much better job of 
that today, then we did in the 1970's and 1980's. I also know 
that drugs that relieve the most severe pain can be those drugs 
that are must dangerous. The value of drugs in relieving pain 
is obviously a double-edged sword. These drugs can create a 
dependency that makes it difficult for sufferers to wean 
themselves off those pain killers, and these pain-killing drugs 
can be diverted for recreational use by abusers. That is 
actually why we have the Controlled Substance Act, that is why 
we hold certain drugs to be in a higher regulatory standard, 
because we are concerned about how they might be used or 
abused.
    I come to this subject knowing that OxyContin has been 
controversial because of abuse and misuse and diversions of the 
drug, and I strongly believe we should work to eliminate the 
abuse of OxyContin and we will. But, I also believe we should 
work to eliminate the abuse of all controlled substances, it is 
not the only one that is addicting, and it is not the only one 
that is dangerous. But how we do this is critical. If we come 
up with solutions that discourage our physicians from 
prescribing appropriate pain killers, pain care in this country 
will take a serious step backward. And we all must remember 
unless you have been there, unless you have had that pain and 
can hardly live with it, you do not understand personally the 
importance of what these drugs can do for you.
    I believe there are several areas we need to address if we 
are going to attack prescription drug abuse and Lord knows we 
need to. I support the use of state-based prescription 
monitoring programs. My friend Congressman Chairman Harold 
Rogers has been funding an appropriation that allows States to 
set up these monitoring programs, and they are out there in 18 
States. With a monitoring program, a State could then catch a 
person who is running from pharmacy to pharmacy getting a 
prescription filled. The State could also raise questions about 
doctors who appear to be illegitimately writing controlled 
substance prescriptions and my view is that if they are and 
they are caught, they ought to be put under the jail. That is 
where one of the problems is.
    Today, there is little in place in this country to stop 
either of these abuses. I come from the time even in the 1980's 
where we had to keep our prescription pads under lock and key, 
because people actually would come into the office for bogus 
reasons hoping that I would walk out of the room where they 
could grab a pad. I believe we need to reign in Internet 
pharmacies. That may be the greatest danger. Right now I could 
go on the Internet and buy a controlled substance just by 
pointing and clicking two things, I need the drug and I am not 
lying. So could my 13 year old granddaughter. There are 
legitimate Internet pharmacists, but those that do not require 
prescription from a treating provider are going to have to 
change the way they do business. That loophole must be closed.
    When a drug leaves a manufacturer, where does it go? The 
more I learn, the more concerns I have that our systems have 
giant holes that allow counterfeit drugs to enter the system. 
Last year, there was a counterfeit Lipitor scare right here in 
Florida. That made it much more difficult for wholesalers in 
this State to sell drugs without knowing where they came from, 
and it should be done. Right now, you can go back and forth 
across the borders of this country with 50 doses of a 
prescription. It is called the personal use exemption. However, 
the law allows you to cross the borders as many times as you 
want to a day with 50 doses. That loophole has to be closed.
    Finally, I want to say a word about OxyContin. OxyContin 
has a legitimate use for patients in severe pain that I believe 
must be preserved. And there are other drugs out there that may 
work just as well. If we banned OxyContin tomorrow, and forbade 
every drug manufacturer from marketing to doctors, does anybody 
in this room really believe that prescription drug abuse will 
go away? It will not, it was there before OxyContin ever came 
on the market. Prescription drug abuse is bigger than any drug, 
and it is not caused necessarily by marketing practices. I have 
an hour's worth of reasoning behind that, but I will not do it, 
Mr. Chairman, right now. What we need to do is close the 
loopholes that are in our system.
    I thank the chairman and Congressman Mica for allowing me 
to be here today. I really look forward to hearing the 
testimony of the witnesses. This is a real learning effort for 
my subcommittee, and I am grateful to both of you. Thank you 
and I yield back.
    Mr. Souder. Thank you. And right now I would like to 
recognize Congressman Keller, many of us were very thrilled to 
see him win his first primary and get elected and become an 
active Member of Congress, and it is great to be here in 
central Florida.
    Mr. Keller. Well, thank you very much, Mr. Chairman. First 
and foremost, I would like to thank my colleague from Winter 
Park, Congressman Mica, for his leadership on this issue, and 
bringing this congressional field hearing right here to Winter 
Park, FL. It would not have happened without his leadership, 
and we certainly thank him.
    Also, because of our lax immigration laws here in Florida, 
a couple of out-of-state Congressman were able to slip through 
our porous borders and come here today. Chairman Norwood and 
Chairman Souder, traveled hundreds of miles to be here and that 
is just a testament to how important this issue is to them. We 
are very lucky, actually we have three subcommittee chairman up 
here so some powerful Members of Congress with the ability not 
only to listen today and learn what the challenges are but, to 
go back to Washington and do something about it. So, I am just 
thrilled that they are here in person in our community.
    As a member of the Crime Subcommittee in Congress, national 
drug control policy is something that is near and dear to my 
heart, and I have to tell you in the interest of straight talk, 
the abuse of prescription drugs like OxyContin presents some 
very special problems for Members of Congress like me. On the 
one hand, these are very powerful and dangerous drugs with as 
high a capacity for addiction as heroin and crack cocaine. On 
the other hand, these drugs have legitimate medical uses and 
may give the only possibility for relief for millions of 
patients suffering from chronic pain, especially those with 
terminal cancer, and so we have to listen today, and try to get 
it in the strike zone and do what is appropriate, and that is 
why we are here.
    And I want to thank you all so much for being here as well. 
Mr. Chairman, with that I will yield back.
    Mr. Souder. I thank each of you for your statements.
    A couple of orders of business first. I ask unanimous 
consent that all Members have 5 legislative days which is 
basically a week to submit written statements and questions for 
the hearing record and any answers to written questions 
provided by the witnesses also be included in the record. 
Without objection, so ordered.
    Second, I ask unanimous consent that all Members present be 
permitted to participate in the hearing. Without objection, so 
ordered.
    Let me explain a little bit first about how we conduct our 
hearings. This is a Federal oversight hearing, it is not a town 
meeting and it is not like a State hearing where people can 
testify. It is only invited witnesses, and that others may 
submit written testimony. So you can submit any written 
testimony either to Congressman Mica's office or Congressman 
Keller. And when I asked unanimous consent that all Members 
have 5 legislative days to submit written statements, which is 
effectively a week, that means it can go through their office. 
We do not take testimony from the floor. As has been explained 
several times this is an oversight committee.
    In 1994, when we first took over Congress this committee 
was probably the most high profile in Congress. We did every 
thing from the Waco hearings to the White House investigations 
on who hired who, the travel office, China, the FBI files and 
so on. And so, all witnesses are sworn in. It is one of the 
only--this is not an intimidation but it is a fact--it is the 
only committee in Congress where people who have testified have 
been prosecuted for perjury. Because it is an oversight 
committee, the statements are presumed to be accurate, so we 
encourage you to qualify if you are not absolutely certain, 
because this is an investigative committee.
    The name of this Subcommittee is Criminal Justice, Drug 
Policy and Human Resources. We have jurisdiction over any drug 
policy and we do authorizing on narcotics issues as well, but 
because of the nature of how Congressman Mica and Congressman 
Hastert pulled together these agencies, we also have 
jurisdiction over HHS and FDA. And we do hearings as well on 
those subjects and the Department of Justice which includes 
DEA. And so we are, for example the only committee in Congress, 
that in addition to drug policy has oversight over both of 
those different areas, and so we can blend and do followup with 
both levels of agencies unlike a health committee that can only 
deal with FDA, or a judiciary committee that can only deal with 
the Justice Department.
    We do different field hearings like this as well in 
Washington. This subject is not unrelated to others that we 
have held on illegal narcotics and the difficulty of sorting 
these things through, but is actually the first one I believe 
on OxyContin directly. And it is obviously being very closely 
watched and it is a great privilege to be here in Florida with 
this hearing. I would like to yield to Mr. Mica.
    Mr. Mica. Mr. Chairman, just a housekeeping point. I think 
Members are aware last week of the ricin scare that we had. 
They did come and collect our mail and also some of the mail 
delivery has been suspended. I have had an extraordinary number 
of request to submit testimony for the record and the chairman 
is leaving the record open for 5 days. However, I would advise 
those who want testimony submitted either to get it to 
Congressman Keller's office, hand carried to Congressman 
Keller's district office, or my district office. We will be 
glad to make certain that it gets to the subcommittee within 
the required amount of time. And I am not sure how you are 
accepting mail, whether we need an offsite location. Maybe by 
the end of the hearing, we can make certain that we have a 
location. There may be some delay in the subcommittee or 
Members of Congress receiving that testimony and that does give 
me some concerns, so we can look into that and, also I think 
the chairman is going to announce a fax number if you want to 
submit for the record.
    While everyone cannot be a witnesses in these formal 
congressional hearings, they do have an opportunity to submit 
for the record testimony.
    Mr. Souder. I thank the chairman, that was a good point 
over the mail. We do not know how much mail, it is not the 
first time and the procedures sometimes take forever to get to 
us. The best way is not to send written materials to our 
offices. Either our fax number for the committee is 202-225-
1154. The safest thing is to get it to a Member's district 
office here in Florida.
    With that, we would like the first panel to come forward. 
Mr. Terry Fernandez of the Central Florida HIDTA; Dr. Robert 
Meyer, of FDA; and Mr. Tom Raffanello, of the DEA. If you could 
come forward and remain standing. Will you raise your right 
hands.
    [Witnesses sworn.]
    Mr. Souder. Let the record show that each of the witnesses 
responded in the affirmative.
    For those who are not familiar we have a 5-minute clock, so 
we have time for questioning. It will turn yellow after 4 
minutes. We will be a little flexible with that, but to make 
sure we have time for questioning and get all our panels in, we 
ask you that all written statements will be submitted. Any 
additional material be submitted. So if you want to summarize--
however you want to do this is fine. Mr. Fernandez, you are 
recognized first.

STATEMENTS OF WILLIAM T. FERNANDEZ, DIRECTOR OF CENTRAL FLORIDA 
 HIGH INTENSITY DRUG TRAFFICKING AREA, OFFICE OF NATIONAL DRUG 
CONTROL POLICY; ROBERT J. MEYER, M.D., DIRECTOR, OFFICE OF DRUG 
 EVALUATION II, CENTER FOR DRUG EVALUATION AND RESEARCH, U.S. 
  FOOD AND DRUG ADMINISTRATION; AND TOM RAFFFANELLO, SPECIAL 
       AGENT IN CHARGE, MIAMI DIVISION, DRUG ENFORCEMENT 
                         ADMINISTRATION

    Mr. Fernandez. I would like thank the Chair and the 
committee for the ability to be here today, and I would like to 
thank you for your efforts in this effort--and in this field.
    The State of Florida has seen an alarming increase in the 
abuse of pharmaceutical drugs in recent years. Most 
specifically OxyContin, and others that contain its active 
ingredient, Oxycodone. The Controlled Substances Act has placed 
Oxycodone under Schedule II due to its highly addictive 
potential.
    OxyContin is a drug with two identities--an FDA approved 
schedule II drug developed for treatment of long term moderate 
to severe pain, and a substance that can be used by the heroin 
addict due to its similar euphoric effect. OxyContin also 
provides the heroin user with the security of a predictable 
potency in a regulated dosage unit. There are instances of the 
OxyContin abuser switching to heroin in some parts of the 
State.
    Abusing an OxyContin tablet is easily accomplished by 
chewing the tablet thereby voiding its controlled-release 
feature. The tablet can be crushed and snorted, or made soluble 
and injected. It is often mixed with other licit and illicit 
drugs which can prove very deadly.
    In 2002, there were 589 drug deaths in the State of Florida 
in which Oxycodone was found in the system. Oxycodone was found 
in lethal amounts in 256 of these. During the first 6 months of 
2003, there were 292 deaths involving Oxycodone. It was found 
in fatal amounts in 136 persons, 48 of whom were central 
Florida residents. Of the 136 Oxycodone fatalities in the first 
half of 2003, 67 percent were over the age of 35 and 16 percent 
were over the age of 50.
    Intelligence indicates doctor shopping, prescription fraud, 
and robbery, are the three most common means of obtaining 
OxyContin.
    The heroin problem in central Florida has certainly 
contributed to the abuse of OxyContin and other drugs 
containing Oxycodone. Further, the lack of availability or 
increase in price of one, motivates the abuser to seek the 
other.
    I cannot recall a substance so diversely abused, crossing 
all age groups, ethnicities and social statuses, with such a 
devastating effect. We know the source of this drug, the retail 
price, the illicit price, the distribution routes, and very 
much about the end user and his supplier.
    I refer to the November 2003 article in the South Florida 
Sun-Sentinel which lists the top 12 OxyContin prescribers for 
Medicaid during the period 2000 to 2002. These 12 doctors wrote 
prescriptions totaling $15,645,745.00. This figure represents 
1,689,605 80-milligram tablets of OxyContin or 9,540,000 10-
milligram tablets. Should our efforts to bring this abuse under 
control not start here?
    The Florida Prescription Validation Program utilizing an 
electronic data base containing prescription history and 
counterfeit-proof prescription forms will certainly assist in 
curbing doctor shopping and forged prescriptions.
    The validation program in cooperation with the Drug 
Enforcement Administration's Office of Diversion Control and 
its registry of physicians prescribing controlled substances, 
should be a natural alliance.
    Thank you.
    Mr. Souder. Thank you, and I should have repeated that Mr. 
Fernandez is the director of the Central Florida High Intensity 
Drug Trafficking Area, Office of National Drug Control Policy, 
which coordinates State, local and Federal anti-drug efforts in 
central Florida.
    Now we are going to hear from Dr. Robert Meyer, Director of 
Office of Drug Evaluation II, I should have said earlier, the 
Center for Drug Evaluation and Research, of the U.S. Food and 
Drug Administration, FDA. Thank you for coming.
    [The prepared statement of Mr. Fernandez follows:]
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    Dr. Meyer. Thank you. Good morning Mr. Chairman and members 
of the subcommittee. I oversee the review division that has 
regulatory responsibility for the high dose of opiate analgesic 
products. And I appreciate the opportunity to talk about FDA's 
drug approval process and our role in preventing prescription 
drug abuse.
    FDA is a public health agency that is strongly committed to 
promoting and protecting the public health by assuring that 
safe and effective drugs are available to the public. FDA is 
aware of and is concerned about reports of the growing problem 
with prescription drug abuse. We understand the seriousness of 
this issue and sympathize with the families and friends of 
individuals who tragically lost their lives or otherwise have 
been harmed, as a result of prescription drug abuse and misuse, 
including OxyContin.
    We also sympathize with the many pain patients who suffer 
needlessly due to under treatment or substandard treatment. In 
taking actions on these matters, FDA must strike a critical 
balance.
    Let me turn for a moment to one of the issues upon which I 
was asked to speak, the FDA drug approval process. Under the 
Food, Drug, and Cosmetic Act, FDA is responsible for ensuring 
that all new drugs are safe and effective. Before any drug is 
approved for marketing in the United States, FDA must decide 
whether the studies and other information submitted by the 
drug's sponsors have adequately demonstrated that the drug is 
safe and effective when used according to the drug's labeling. 
When the benefits of a drug are found to outweigh the risk, and 
the labeling instructions allow for safe and effective use, FDA 
approves the drug for marketing.
    There are instances where FDA may develop, in cooperation 
with the drug sponsor, a plan of intervention beyond just 
labeling to help assure the safe and effective use of a drug. 
This has recently been referred to as risk management plans 
[RMP], but the practice dates back many years. These 
interventions making up an RMP may be varied but all are aimed 
at assuring that some known or potential issue regarding the 
proper issue of the drug is addressed when the drug is used.
    During the approval process, FDA assesses a drug product's 
potential for abuse. If a potential for abuse is found to 
exist, the product's sponsor is required to provide FDA with 
all data pertinent to the abuse of the drug, a proposal for 
scheduling the drug under the Controlled Substances Act and 
data on overdoses. Under the Controlled Substances Act, FDA 
must notify DEA if a new drug application is submitted for any 
drug that is assumed to have abuse potential, and that includes 
depressants, hallucinogenics, or stimulants.
    Finally, it is important to state that FDA's job is not 
over when the drug is approved. The FDA conducts post-marketing 
surveillance that monitors drugs post-approval for their 
safety, allowing for reassessments of drug risk based on new 
data learned after marketing. When needed, we then recommend 
ways to most appropriately manage these newly identified risks. 
In part prompted by our experience with OxyContin post-
marketing, FDA has undertaken a number of actions to help 
prevent prescription drug abuse.
    First amongst these is FDA's actions and planned actions 
with the regard to drug labeling of the high dose opiates, 
particularly the extended release products. Labeling not only 
serves as an important means of informing prescribers and 
patients about the proper use of a drug, but also importantly 
defines the bounds of marketing and advertising for that drug. 
Labeling to these opiate products should emphasize that drug 
treatment for pain should be initiated at a lever appropriate 
to the pain and condition of the patient.
    Additionally, labeling should help prescribers properly 
assess potential patients for the likelihood of abuse. In 
particular, patients with a personal history of substance abuse 
or a strong family history of abuse should be considered as 
being at higher risk for drug abuse. It should be noted that 
when significant changes are made to a drug's labeling, FDA 
encourages the drug sponsors to notify health care 
professionals, and to educate them about the serious risks. And 
FDA helps in the dessimination of this information via its Med 
Watch program and its Web page, amongst other means.
    A second important means by which FDA addresses issues of 
drug abuse is through the regulation of prescription drug 
marketing.
    A third way that FDA can use to address these problems is 
through the development of risk management plans as I mentioned 
earlier.
    A fourth means that FDA uses to meet this challenge is by 
working with other involved entities, such as government 
agencies, industry and professional groups. We work with them 
to share information and insights needed to address this broad 
problem. For instance, FDA and DEA meet regularly to discuss 
ways to prevent prescription drug abuse and diversion, and we 
are working on the following areas with DEA: physician 
education, State prescription drug monitoring programs, a joint 
task force participation focused on illegal sale of controlled 
substances, and the assessment of new products with abuse 
potential.
    In conclusion, FDA recognizes the serious problem of 
prescription drug abuse. The agency has taken many steps to 
address this serious problem and will continue to act to curb 
abuse, misuse, and diversion. Since this problem is broad in 
its scope and implications, we are committed to working with 
our partners. We share the subcommittee's interest and concerns 
regarding prescription drug abuse and would be happy to answer 
any questions.
    Thank you.
    Mr. Souder. Thank you. We will now hear from Mr. Tom 
Raffanello, Special Agent in Charge, Miami Division, Drug 
Enforcement Administration. Thank you for coming today.
    [The prepared statement of Dr. Meyer follows:]
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    Mr. Raffanello. I am here before you today to discuss the 
challenge of prescription drug abuse, and the efforts of the 
DEA to combat it. My name is Tom Raffanello, I am the Special 
Agent in Charge of DEA's Miami Field Division, which is the 
entire State of Florida.
    I would like to thank this subcommittee on behalf of 
Administrator Tandy for your unwavering support of the men and 
women of the Drug Enforcement Administration and its mission.
    Opiates in pill form have historically been among the most 
abused prescription drug, especially hydrocodone, hydromorphone 
and oxycodone. Diverted from legitimate channels these drugs 
can substitute for illegal narcotics and are frequently 
trafficked on the street by individuals or structured 
organizations. As far back as the 1970's, hydromorphone based 
Dilaudid was known on the street as drugstore heroin. 
Prescription drug abuse has recently escalated to a new level 
of concern with the development of opiate-based pain killers 
designed for controlled or sustained release. These products 
pose special challenges to law enforcement. It is easy to see 
why when you consider OxyContin contains 2 to 16 times the 
dosage of oxycodone as its well known predecessor Precodan.
    OxyContin is also the most widely known example of an 
abused prescription drug, and its diversion has increased 
dramatically since its introduction into the market. OxyContin 
is a valuable and efficient pain management drug when properly 
prescribed and used. At the same time, however, its popularity 
for abuse sky-rocketed when word made its way to the street 
that manipulating this powerful drug can bring heroin-like 
effects. DEA has never witnessed such a rapid increase in the 
abuse and diversion of a pharmaceutical drug product.
    The popularity of OxyContin and other drugs of abuse have 
also inspired a wide range of diversion methods, some new and 
some old. Practitioners and pharmacists illegally or 
indiscriminately prescribe or dispense OxyContin for profit. 
Addicts and dealers steal drugs through pharmacy thefts and in-
transit highjacking. Forged or fraudulent prescriptions are 
common occurrences as are patients who claim false medical 
needs. Doctor shopping abusers travel from doctor to doctor to 
find an easy mark who will readily write prescriptions or who 
can be duped.
    Foreign diversion and smuggling of contraband drugs into 
the United States continues to be a problem. Perhaps the 
greatest concern, the Internet, has become a virtual wild west 
bazaar for spam e-mails and Web site advertisement that sell 
controlled substances with little or no oversight that the 
drugs are sold for legitimate medical reasons.
    At times, multiple methods of diversions occur 
simultaneously. In Sarasota, FL, a physician recently was 
arrested for writing prescriptions for controlled substances to 
known drug dealers and abusers including Dilaudid and 
OxyContin. The doctor saw as many as 80 patients daily, charged 
$250 for an initial office visit and $150 for followup 
appointments. During the search of the physician's office, DEA 
and local law enforcement seized approximately 25,000 dosages 
of controlled substances including large quantities of 
oxycodone, methodone, and hydrocodone.
    In response to growing concern among Federal, State, and 
local officials about the dramatic increase in the illicit 
availability and abuse of OxyContin, the DEA initiated an 
OxyContin action plan in May 2001 as a comprehensive effort to 
prevent diversion and abuse of the drug. This is the first time 
the DEA has taken such a comprehensive approach to a particular 
brand name prescription drug. The initiative is not intended to 
impact the availability of OxyContin for legitimate medical 
use.
    The plan has four main goals: First, to enhance the 
coordination of enforcement and intelligence programs with 
other Federal, State, and local agencies to target individuals 
and organizations involved in the illegal sale and abuse of 
OxyContin.
    Second, to use the full range of regulatory and 
administrative authorities to make it more difficult for 
abusers to obtain OxyContin. The DEA does this by closely 
monitoring the quota of oxycodone available to manufacturers, 
continue to work with the FDA to reduce the abuse of 
reformulated OxyContin by injection, and to continue our 
efforts to improve physician education on treatment of pain and 
recognition of addiction.
    Third, increase the cooperative efforts with the 
pharmaceutical industry.
    Fourth, advanced national outreach to educate the public, 
the health care industry, the schools, and the State, and local 
governments on the dangers related to abuse and diversion of 
OxyContin.
    DEA is also, working with States on prescription monitoring 
programs, to prevent diversion at the State level. PMPs capture 
information regarding prescriptions electronically at the point 
of sale, usually the pharmacy. The information is transmitted 
to a State agency to identify the doctor shoppers, and/or other 
evidence of diversion. Sixteen States have activated PMPs and 
another five States have partial or pending programs. The 
General Accounting Office concluded in a 2002 study that PMPs 
have aided investigators and helped to reduce doctor shopping.
    For the past 2 years, Congress has appropriated funds for 
States to initiate and expand PMPs. Florida has applied for an 
enhance grant of $350,000 to augment an initial grant beginning 
in January 2005.
    Mr. Souder. Mr. Raffanello, if you could kind of summarize.
    Mr. Raffanello. Surely.
    The DEA is committed to protecting the American public's 
health and safety from the serious consequences of abuse of 
legal pain relief for life destroying illegal purposes.
    Initiatives like the OxyContin action plan, PMPs and 
additional diversion investigators to be able to work on the 
Internet abuse that we have will help the enforcement effort 
that we feel is the key into slowing down and doing with the 
problem.
    I thank you very much, and I will answer any questions that 
you gentlemen have.
    [The prepared statement of Mr. Raffanello follows:]
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    Mr. Souder. Thank you.
    Let me start with Dr. Meyer. You said in your testimony 
that the FDA did not anticipate what was going to happen when 
you first cleared this OxyContin. Do you seek input from DEA 
and all the anti-narcotic agencies when you are clearing it?
    Dr. Meyer. We notify DEA, of the fact that we have the NDA 
in house and we work with DEA on establishing a quota for the 
drug substance that goes into the drug product.
    Mr. Souder. Do you believe that the actions, because you 
gave me a list of actions that you have done since then 
because, according to your testimony, as the abuse spread, FDA 
then changed labeling, and you have been trying to catch up. Do 
you believe had you done all those things at the beginning, we 
would not have this problem or do you believe that the things 
that you are doing are not effective in stopping the problem 
unless something else is done?
    Dr. Meyer. I think that the things that we have done will 
have an effect and I think if we had put them in place at the 
beginning, that we would have less of a problem than what we 
have now, but I think the problem goes beyond the means 
available to the FDA, or beyond this particular drug.
    Mr. Souder. Mr. Raffanello, you stated that there has not 
been another prescription drug abused at this level?
    Mr. Raffanello. That is correct.
    Mr. Souder. Anything even approximating?
    Mr. Raffanello. I believe Dilaudid for many, many years has 
been used as a heroin substitute, and very effective.
    Mr. Souder. What would you have done differently at the 
beginning, and as we look at other similar things possibly 
coming on the market, because at this point if OxyContin went 
off something else would likely come on. What would you do 
different at the very beginning in addition to some of the 
things I think we are trying to address now, because once it 
starts to explode, it is just so hard to control it?
    Mr. Raffanello. Being a career law enforcement officer, I 
would make sure that practitioners and pharmacists knew that 
there would be a penalty to pay for over-prescribing or for 
doing anything that even smites of going against the law. I 
think strong law enforcement would be a key.
    Mr. Souder. Mr. Fernandez, you stated in your testimony 
that you would first look at--which is kind of a logical 
business approach--at the top 10 people who are currently 
prescribing it. Is that not being done? It does not mean that 
they are doing it illegally, but why would that not be the 
first place you would look? I think your testimony said that 
there were the top 12 OxyContin prescribers for Medicaid, the 
12 doctors that wrote prescriptions this figure represents so 
much, should our efforts to bring this abuse under control not 
start here? Why would it not start here, what is keeping it 
from starting there?
    Mr. Fernandez. I do not know that anything is keeping it 
from being started. I think I made the statement basically to 
show you--I mean, to me it is just inconceivable that 12 
doctors wrote prescriptions totaling that much. And that is 
just Medicaid. I do not know how many more they wrote that had 
nothing to do with Medicaid.
    Mr. Souder. You coordinate the Central Florida HIDTA, Mr. 
Raffanello is the Miami DEA person, we have the representative 
from FDA. I would like to know why would it not start there, 
and why has nobody started there?
    Mr. Fernandez. I do not think it is--and I could be wrong 
here, but I do not believe anyone knows when they are writing 
it until after the fact, and then it is too late. That is why 
at the end of mine, I recommended this the Florida----
    Mr. Souder. Who has jurisdiction to start that? Would that 
be an FDA responsibility to look at that currently, and say we 
have 12 doctors who wrote this many? Here is what it seems 
like. I am a Member of Congress, and this is still what it 
seems like. I thought it would be different after I got out of 
the private sector into the public sector, that when we go 
after hospitals in the United States for Medicaid or Medicare 
or whatever, it seems like we take the ones that are easy 
pickings off the tree who are filing all the stuff and we get 
somebody who has 2 percent of the market and skip the people 
who have 90 percent of the market. It does not mean that these 
12 doctors are doing anything wrong, but why would that not be 
the first place you look to check and see what the failures of 
the system are? Have those people been looked at and who would 
be responsible for that, I do not understand here?
    Mr. Raffanello. Maybe I can help. The Drug Enforcement 
Administration has a diversion responsibility, and in that 
responsibility we monitor practitioners and doctors. I would--
unfortunately I would like to go back to the times that 
Congressman Norwood said, when they were kept under lock and 
key. It is one thing to be able to look and see a pattern, it 
is another thing to effect an arrest, and get someone to 
prosecute the case. It is very, very difficult to prosecute and 
convict a doctor or a prescriber for one of these types of 
offenses initially. But in my opinion, that is where the work 
really needs to be done. If people that prescribe this knew 
there was a severe penalty to pay, you would have less people 
doing it. And that is where we should start.
    Mr. Souder. Mr. Mica.
    Mr. Mica. Let me just continue along the line of 
questioning of Chairman Souder. It is difficult to convict--
where is the flaw, is it in the Federal law, is it in the FDA 
regulations of the narcotic? What is the problem?
    Mr. Raffanello. I think it is a fairly new phenomenon. I 
think that the States may in some cases not have the law. We 
have--in Federal statutes, we can take the doctor's license 
away. Criminal statutes are always the last resort. I would 
like to see prosecutors more energized to pursue criminal 
statutes, I would like to see the States work through their 
legislation to have severe criminal penalties for doctors, for 
pharmacists, and for people that prescribe it. I think that the 
groundwork is there, I just do not think we have them to the 
level that we need to have them to make the impact that we want 
to have.
    Mr. Mica. Is this something we need to do from a Federal 
level or State by State? I mean, it does not sound like we can 
get a handle on it if we rely on 50 legislatures to act.
    Mr. Raffanello. Speaking from the Florida situation, we are 
very fortunate here. I work with Jim McDonough, the director of 
the Florida Office for Drug Control, and they aggressively 
pursue this in the State of Florida.
    Mr. Mica. But, again, OK that is a State agency, we have 
the HIDTA which does the combination State, Federal, all 
efforts, you are DEA, Federal. Do you have enough laws and 
tools to deal with this? You also testified and we heard 
similar testimony about diversion, about Internet access. 
Chairman Norwood said that his young 13 year old could get this 
stuff in quantities. We need to know where the gaps are and if 
they are Federal gaps we need to know that, and particularly 
from you. So you are recommending tightening one, two, three, 
tell us?
    Mr. Raffanello. At first I would look--the Internet has 
been a tremendous source for drug distribution. I would go back 
and see what we have. If someone in Oklahoma, took applications 
and prescribed drugs in Florida, they should be able to be 
tried in whatever district is affected. I believe that the law 
on that is very vague right now.
    Mr. Mica. Right. Now, the other thing you have is people 
becoming addicted to a legal source of the prescription and 
then the second part is illegal availability through 
prescription fraud. You described prescription fraud. How do we 
address that from a Federal standpoint? Those two.
    Mr. Raffanello. I would go back to more inspections on 
doctors and pharmacists, and tighter reins on just what they 
are doing. I think the prescription program that we are now 
trying to work with Congressman Rogers' help would be something 
that I would like to see supported, so we can automatically see 
who is being prescribed. I think we have mechanisms that need 
to be tightened up there, and need to be applied across more 
States.
    Mr. Mica. All right. FDA.
    Dr. Meyer. Yes, sir.
    Mr. Mica. Abuse of narcotics as we have heard, I gave this 
historical sequencing, starting in this room with election of 
Senator Hawkins, the cocaine problem, the heroin problem. Of 
course, we have cited here a different prescription drug 
problem and this is now a prescription drug of choice that we 
found being diverted. Has FDA adequately changed its rules, its 
regulations regarding abuse and misuse of this substance?
    Dr. Meyer. I think that a lot of the abuse and misuse is 
occurring in circumstances where FDA does not actually have 
strict purview. I think our main----
    Mr. Mica. So does the law need to be tightened to give you 
that purview?
    Dr. Meyer. I think I would defer to DEA, since DEA has the 
jurisdiction on this, whether they would need something, but, 
FDA does not regulate the practice of medicine. Much of this is 
occurring in the setting of----
    Mr. Mica. Well, you discovered a drug where we have deaths 
off the chart here that doctors are--and we have had testimony 
here of 12 doctors on Medicaid issuing incredible volumes of 
this stuff and people are dying in an unprecedented numbers. So 
you either you change the rules or we change the laws, and if 
we need to change the law, do we have enough laws directing FDA 
to deal with this or do you already have that authority?
    Dr. Meyer. Again, I do not believe we have the authority to 
act with regard to how these drugs are used in the practice of 
medicine.
    Mr. Mica. All right, I want you to submit to me a written 
statement. You can do it through the committee of what it would 
take for you to have the authority under the law to more 
aggressively pursue this matter, can you do that?
    Dr. Meyer. We can do that, be happy to do that.
    Mr. Mica. As an agency--and I would like you to submit the 
same thing to me as far as any loopholes or changes that DEA 
sees--our enforcement agency--so we have a better handle on how 
we can change the law. You have the ability to change 
regulations already within the law, so I need to know 
specifically what we can do.
    Mr. Fernandez, you talked a little bit about electronic 
data validation, the problem with getting a handle on people 
who are prescription shopping and I was interested in that. 
Could you elaborate a little bit more how we get a handle on 
medications, not just OxyContin, but drugs that can be used, 
prescription drugs that can be used and abused, and how do we 
get a better handle on all of this?
    Mr. Fernandez. Yes, sir. I think there is a gap between the 
doctor writing the prescription and the people that give that 
doctor the ability to write that prescription. I do not think 
the Federal level gets the information as rapidly. I do not 
know if they get it at all in some cases, but I certainly do 
not think they get it in a timely manner. That was one reason I 
referred to the Florida prescription validation program. And I 
do not claim to be an expert on that. Mr. McDonough can 
certainly tell you more about that then I could. But, as I 
understand it, a prescription would be written and it would be 
computerized and State officials would know. I would assume 
then they would see a doctor writing more than he should be.
    Mr. Mica. It disturbs me when we have a Federal program and 
you cited, right, 12 Medicaid doctors?
    Mr. Fernandez. I got that from a newspaper article; yes, 
sir; 12 doctors wrote prescriptions totaling over $15 million.
    Mr. Mica. So, a Federal program they are gaming to bring on 
the market, a substance of which hundreds of our people are 
dying. Well, I would like to--Mr. Chairman, I did have an 
opportunity to meet with some folks I believe that are involved 
in this electronic data validation program under Medicaid, 
which I believe the feds and also, the State is supporting. I 
would like to ask unanimous consent to submit for the record 
testimony by Jim Kragh who is the president of Good Health 
Networking. He demonstrated to me I guess this is just a little 
type of a Palm Pilot. But the software does electronically 
validate prescriptions, gives us a better handle on what 
prescriptions and what amounts, and who the users are.
    So, I would like Mr. Kragh's testimony to be submitted as 
part of the record, describing what I understand in central 
Florida we have over 800 physicians participating in this demo 
to get a handle on where these prescriptions are written. So I 
ask unanimous consent for that submission.
    Mr. Souder. Without objection, so ordered.
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    Mr. Souder. Mr. Norwood.
    Dr. Norwood. Thank you, Mr. Chairman, I appreciate it. Let 
me, I would be remiss if I did not introduce you to our court 
reporter, Bill Warren. He is my only voter in this room, and I 
am glad Bill is here from Monroe, GA.
    Mr. Fernandez, you said in your report, intelligence 
indicates doctor shopping, prescription fraud and robbery are 
the three most common means. Just so you and I are on the same 
page, define doctor shopping?
    Mr. Fernandez. Going to one doctor and getting as much as 
you could on a script, claiming to have pain, going to a second 
doctor within probably a short period of time, getting another 
prescription written for the same.
    Dr. Norwood. I would define it the same way, I just was 
trying to see if you meant by that going to 1 of the 12 who the 
underground knows is writing bogus prescriptions. Is that 
doctor shopping, too?
    Mr. Fernandez. Yes, sir.
    Dr. Norwood. Just to make the record clear there are 
thousands and thousands of physicians in Florida that take 
Medicaid, and the fact that we are talking about 12 makes me 
wonder why we could not deal with that 12. You obviously have 
information, do you have that information, on those 12?
    Mr. Raffanello. I am unfamiliar with it.
    Dr. Norwood. Why would you know that, and he not, because 
any time 12 physicians are writing $15 million worth of 
Schedule II drugs, my dander goes up a little bit. Something 
does not smell right about that immediately, and I would think 
somebody ought to be asking those people some questions. What 
is going on with that 12? Recognizing what you said is so true, 
this is very difficult, I will get into that in a minute.
    Mr. Fernandez. I got the information from a newspaper 
article that I referred to earlier, but they named the doctors, 
there were 12 doctors.
    Dr. Norwood. So we know who perhaps--through Medicaid 
records, who these people are?
    Mr. Fernandez. Oh, without a doubt, and all of these 
doctors had prior problems, would probably be a good word. I 
think they have had some run-ins with different medical boards 
and what-have-you.
    Dr. Norwood. Just to make this point too, taking the 
license is not the solution. Frequently that drives the 
physicians underground. They do not have a way to make a 
living, it just gets worse in my opinion. There needs to be 
criminal activity, as you pointed out, involved in this and the 
penalty for this needs to be very, very steep. That does not 
mean maybe the license is not taken and they can practice in 
prison, but my view is we do not take it seriously enough. I do 
not know the percentage. I do not know the number of doctors 
that see Medicaid, but that is a low percentage. At least that 
12 ought to be visited on a pretty regular basis.
    One of you were pointing out earlier, all of this, these 
prescriptions, you do not know about it frequently, until after 
it the fact. And that is what we are looking at in our 
committee is how you could know it a little sooner. Because 
there are patterns that occur. I mean, just like this 12, you 
can know who they are pretty easily. This 12 do not just see 
Medicaid patients, incidentally.
    So you do not really know the numbers until you go in, 
until this is a criminal problem rather than just a problem 
with the ethics committee or the State board of dental 
examiners.
    I am glad to hear you talking about the Internet. I 
wonder--and we are thinking about this too--if we outlawed in 
this country the purchase of Schedule IIs over the Internet, do 
any of you know how much might be available out of this 
country, to buy over the Internet from India? And we do not 
know how to fix that. We do not know how in the world we would 
keep it from coming across the Internet if we closed down every 
Internet prescription shop in America. Any comments, any 
thoughts?
    Mr. Fernandez. I cannot answer that question, but I would 
ask the good doctor here, we do know who produces OxyContin. Is 
it just one company?
    Dr. Meyer. OxyContin is only produced by one company, but 
oxycodone has many sources and I do not, as the U.S. regulator 
of drugs, we do not have a good handle on, say who might 
produce it in India, unless it is for a U.S. manufacturer.
    Dr. Norwood. Well, this is so profitable even though I do 
not know where the company is that produces OxyContin, but it 
is so profitable, if we shut that company, or control them 
tight, it is going to pop up somewhere else.
    Which is part of my point of this hearing. The Dilaudid, 
look I remember when people were trying to come in and get 
Dilaudid. Now they want OxyContin. Though I never prescribed 
OxyContin it seems to work really well for pain relief, which 
means it also works really well for the people who would abuse 
it. That is why they want that today, that is the popular one 
today. It used to be Percocet, Percodan. You guys have been 
around long enough to remember when that was. But we have to--I 
think it ought to be a State program, Congressman Mica, maybe 
under a Federal umbrella, because we have to cross State lines. 
You have to be able to--if you are going to stop doctor 
shopping they cannot come to three doctors in Augusta, GA, 
cross the Savannah River and go to three in Aiken, SC, without 
us having some handle on that.
    Part of the difficulty is how do you do this with privacy. 
But somewhere, somebody, has to collect this information and it 
has to be electronic and automatic, they do it now anyway. They 
immediately send out electronic messages to get paid from the 
pharmacist. That same message could go to some collecting 
point, so that we do know and you could know in the State of 
Florida. You pick up abuses on that in 2 minutes. Do you need 
more--you need the penalties to be greater, do you not?
    Mr. Raffanello. Yes, absolutely. I have just two points I 
would like to make in response to your question----
    Dr. Norwood. Please.
    Mr. Raffanello [continuing]. About out-of-the country 
sources. If past be prologue, in the past when we had problems 
with Qualudes--and we did a very efficient job in the United 
States banning them--Mexican traffickers took to taking the 
precursor chemicals, took to using the pill presses, and did 
exactly that in Mexico. The Mexican and Colombian traffickers 
are very, very ingenious. They will fill a void. If there is a 
need, they will fill a void. I think that eventually they would 
probably use the Internet or use 2,200 miles of border. They 
will use whatever they perceive is a weakness to be able to do 
it. And that is something that could happen in the future and 
that is something that DEA, intelligence-wise, is looking at.
    Second, on 12 doctors with Medicaid, primarily Medicaid 
fraud is--I believe there are several other Federal agencies 
that have that initial responsibility. What happens in those 
scenarios is when they get to the point where they want to 
pursue a Title 21 offense, then they will call DEA and bring 
DEA in. But the vast majority of the time, the offense is 
initially discovered by the agency with the oversight of the 
doctor on the Medicaid program.
    So it is not--I do not have the manpower to be able to 
cover every doctor in Florida, and DEA does not have that kind 
of manpower, but the people with Medicaid oversight, if they 
see something that does not look good, they will often call us. 
And if it is another Federal agency, they may have Title 21 
authority, and they may do it themselves.
    Dr. Norwood. Have they called you about these 12 doctors?
    Mr. Raffanello. Not at this point.
    Dr. Norwood. Then they are not doing their job.
    Mr. Raffanello. If it were the Federal Bureau of 
Investigation, they have concurrent jurisdiction to Title 21. 
So they may decide to enforce that themselves, that is a 
possibility. I promise you that I will find out more about it.
    Dr. Norwood. Well, in conclusion, Mr. Chairman if I may, we 
can stop I believe immediately--not immediately but pretty 
quickly--the three problems you are talking about. Maybe 
robbery is a different subject. I know one time I caught a 
fellow trying to abuse the Percodan deal and we took care of 
that real quick. We had your folks over there immediately, and 
of course they tried to burn our office down after that, in a 
few weeks. I am just telling you how bad these people want 
these drugs, and they will do anything for it.
    But I think we can probably stop the problem of doctor 
shopping, I think we can stop prescription fraud, maybe we can 
never stop robbery. In the long term, at the end of the day, 
the real problem for us about people abusing and getting too 
many Schedule II drugs, is going to be just what we are talking 
about--it is going to be the Internet, and it is going to be 
foreign sources. And you guys are really smart and need to help 
me figure out how to do that.
    Thank you, Mr. Chairman.
    Mr. Souder. I think this Georgian is downplaying his own 
smartness. That is, I take it, a southern trait. A very smart 
man. Mr. Keller.
    Mr. Keller. Thank you, Mr. Chairman. Just to followup on 
something Congressman Norwood was hitting on. Mr. Fernandez we 
know from your testimony we have 12 physicians who have written 
over $15 million worth of Medicaid prescriptions for OxyContin, 
that is 9.5 million tablets. As of this morning anyway, the 
south Florida newspaper Sun-Sentinel, has known for 4 months 
who these people are, but as three Federal experts sit here 
today, we do not have a clue if they have even been 
interviewed, any of these doctors by the DEA or FBI.
    Mr. Raffanello, what can you tell us about the future 
prospects with respect to these 12 doctors who have now been 
identified through public records, and a newspaper; will they 
at least be interviewed by some law enforcement agency?
    Mr. Raffanello. Let me say this, I have 22 officers in the 
State of Florida, and because I do not know about it, I am 
assuming the DEA is not part of it. I very well may find out 
that we are. I have not read the article, I am not familiar 
with it, I am not familiar with that incident, but all that 
aside I take responsibility for it, and I assure you that I 
will find out who has the investigation and they will be talked 
to.
    Mr. Keller. OK, I will tell you, that reminds me, you know, 
September 11, we had 15 of the 19 highjackers came here from 
Saudi Arabia. We had one guy at the State Department that 
issued 10 of those visas. Afterwards nobody talked to him. And 
I look at this situation--I do not know if we need new laws 
right now, maybe just some enforcement of the existing ones, 
and maybe they are being enforced and we just do not know. We 
have to get to the bottom of that.
    Let me ask you a question, Dr. Meyer, are there any 
specific marketing practices by the distributors of 
pharmaceuticals that you would like to see stopped with respect 
to OxyContin?
    Dr. Meyer. The FDA has actually found that the vast 
majority of the marketing of OxyContin specifically has been 
within our legal bounds. We have in two incidences cited them 
for deviating from acceptable practices, going beyond the 
labeling or not giving sufficient warnings about the misuse and 
abuse of the drug.
    I would say that the company itself has voluntarily elected 
not to directly market to consumers, and we wholeheartily agree 
with that.
    Mr. Keller. Does that mean they have not done any TV ads 
for OxyContin.
    Dr. Meyer. They have not done any TV ads.
    Mr. Keller. OK.
    Dr. Meyer. Right.
    Dr. Norwood. Would the gentleman yield?
    Mr. Keller. Yes, I will yield, Mr. Norwood.
    Dr. Norwood. As long as they do not market to the public, 
which I would be 100 percent against, and so I understand they 
are, too. We need to remember who they are marketing to. 
Actually they are talking to people and trying to encourage 
them to, and explain their new drug, who should know the 
pharmacology inside out, who should know the ill effects and 
particularly the addictive effects, and my view on that is that 
shame on the doctor who does not explain that to their patient. 
It is not like they are being talked into using something they 
do not understand, they do understand, they understand the 
pharmacology of it.
    That is why I said earlier in my opening statement, the 
marketing to a physician is not abnormal. Most drug companies 
do want you to use their particular product over another 
product, but they are not talking to people who totally do not 
know what they are being asked to use. So, I blame it on the 
doctor who does not explain it to their patient that we need to 
be very careful here and monitor that patient.
    Dr. Meyer. I would point out, Dr. Norwood, that I think I 
agree with a lot of what you are saying, pain management has 
changed greatly in the last 10 to 15 years. When I was licensed 
in the State of Oregon, we had a mandatary training in pain 
management prior to getting our license. That was about 12 
years ago. A lot of what I was taught then is no longer 
believed to be true now, so the FDA----
    Dr. Norwood. Thank goodness.
    Dr. Meyer. Pardon.
    Dr. Norwood. Thank goodness.
    Dr. Meyer. Thank goodness. I think the FDA in conjunction 
with DEA and others is supporting better education, because I 
believe that part of this is education. There is a need for 
physicians to better understand both the good points of these 
medicines, how to effectively treat pain, how to screen for 
abuse and how to help prevent abuse as well. While I think a 
lot of physicians are very well educated in basic pharmacology, 
these are specialties or special skills that are not 
necessarily effectively taught in medical school. So it is 
really incumbent on us to continue the education efforts.
    Mr. Keller. Thank you, Dr. Meyer.
    I have one final question for Mr. Fernandez and Mr. 
Raffanello. The one common denominator from all the questioning 
from the various Congressman today seems to be that they are 
very interested in having the Federal Government crack down on 
the practice of selling OxyContin in similar drugs over the 
Internet. You seem to have a sympathetic Congress on this 
issue. Mr. Raffanello, let me start with you. Do you have any 
specific steps that you would like the Federal Government to 
take to crack down on this practice of selling OxyContin over 
the Internet?
    Mr. Raffanello. Yes, and thank you. I would like to do a 
review and find out what the existing laws are. As I explained 
before, you will run in to venue problems, prosecutorial venue 
problems.
    Second, that a condition of prescribing some controlled 
substances that a physical exam be given, you cannot give a 
physical exam over the Internet. I think we can dispense with a 
lot of that if we review what we have and let it evolve to take 
in the fact that it is being exploited by crooks on the 
Internet.
    Mr. Keller. That sounds great, especially a physical exam 
requirement there. Mr. Fernandez, do you have anything to add 
to that?
    Mr. Fernandez. No, sir, I do not. I think that covers it 
pretty well.
    Mr. Keller. OK, Mr. Chairman, I will yield back.
    Mr. Souder. Thanks.
    I want to do a couple of followup things to make sure we 
have these in the record, because we kind of plunged right in 
with certain implied things. Mr. Fernandez, it seemed from the 
chart I have heard some of the information that there are more 
OxyContin deaths than heroin deaths in Florida, at least there 
were in 2002?
    Mr. Fernandez. In central Florida, there were not, there 
were more heroin deaths. I really cannot speak well for the 
whole State. I kind of concentrate my efforts for seven 
counties.
    Mr. Souder. OK, let us talk about central Florida for a 
second. The OxyContin deaths were approximating heroin or far 
behind? What is the extent of the OxyContin problem here in 
central Florida?
    Mr. Fernandez. It is very bad and growing. And I think 
Congressman Mica mentioned it earlier, it has happened rapidly 
and I would like to think that it has peaked, but I do not 
think it has. Heroin is continuing to grow.
    Mr. Souder. Would you compare this to the other threats in 
the community here from the other narcotics? Is OxyContin, when 
you get addicted, there are more overdoses and it does not have 
as much violent crime related to it? Is there a tendency if you 
get this stolen OxyContin to peddle it, and do you have a 
dealer network? Or are the doctors in effect who are illegally 
doing this--give us the social consequence in the community and 
in hierarchy of trying to decide what your HIDTA focuses on 
where you see OxyContin?
    Mr. Fernandez. My HIDTA is not a good sounding board to be 
very honest with you. We concentrate on heroin, and we have a 
DEA led heroin task force that looks at strictly heroin. We 
have seen surprisingly little OxyContin tablets, we have not 
seized very many at all. I think it is for a couple of reasons. 
One I think it is because they come through doctors and the 
people that we put on the street, our task force do not look 
there. And I think it has moved in relatively small amounts. 
And we are constantly encouraging our people to look at 
organizations and, you know, just bigger distributors.
    So far as the addictive abilities and what have you, 
certainly it is on par with heroin.
    Mr. Souder. Let me ask you something, Mr. Raffanello, do 
you see OxyContin as a greater problem in other parts of 
Florida, other than central Florida? I am trying to get a 
handle on--let me get to my end point here. Why is there not a 
HIDTA sub-task force on OxyContin, or a DEA task force on 
OxyContin in Florida that is pursuing this?
    Mr. Raffanello. Because, OxyContin--our biggest threat in 
the State of Florida is heroin, and the heroin deaths exceed 
the OxyContin deaths. Our second biggest threat is 
methamphetamine. We have gone from 25 methamphetamine labs 
several years ago to over 250 this year. We have a different 
client that uses OxyContin and oxycodone. Unfortunately, 
sometimes a student or someone will cocktail, will take 
OxyContin with something else. Most of these oxycodone deaths 
are not based on oxycodone alone, it is part of what else is in 
their system.
    In the big scheme of things for us, it comes in third in 
this particular area. And working with the same amount of 
people we have worked with as agents over the last 10 years, we 
have to prioritize to our biggest threat. It is not our biggest 
threat.
    Mr. Souder. I cannot remember where I saw it in the 
materials I was reading for the hearing that I thought it was 
in Florida that the OxyContin deaths exceeded the heroin. You 
are saying there are poly drugs?
    Mr. Raffanello. That is correct.
    Mr. Souder. Are you saying deaths exceed it?
    Mr. Raffanello. No, it is not deaths, it is addiction, it 
is people in emergency rooms. If you just looking for the 
deaths, I believe my theory is correct, that it is still heroin 
deaths that, unfortunately, are the No. 1 here. But 
methamphetamine, because of the endangered children--we are 
trying to cover all three; oxycodone, at this point is not in 
their league.
    Mr. Souder. So you are saying basically that oxycodone is a 
danger to the user predominantly?
    Mr. Raffanello. Yes.
    Mr. Souder. Whereas the difference with meth, even though 
as many people may not be dying, it is impacting the others in 
the home more?
    Mr. Raffanello. Communities, children, we do not even know 
what some of those chemicals do to the environment.
    Mr. Souder. How many people have to die and at what level 
does OxyContin have to become a problem here in central 
Florida, and Florida, before it becomes a part of a HIDTA 
request or a DEA request?
    Mr. Raffanello. Well, that is not our criteria. If we see 
an emerging trend, and we have, I only have somewhere in the 
vicinity of 25 diversion investigators for the entire State. 
And that also includes regulatory functions and that also 
includes inspection functions. So, quite frankly I am trying to 
cover a large State with a relatively small amount of people.
    Mr. Souder. One of the things, however, it does not 
prohibit either the HIDTA or the DEA from requesting to 
headquarters, and then the headquarters can request to Congress 
and put the blame on us, if we have not funded, which is part 
of the problem. We have not necessarily funded--we rail against 
all the different problems and then do not necessarily 
adequately fund them.
    But, in trying to sort through, it has clearly been an 
emerging problem, and I am trying to figure out why there has 
not been a focus or it seems to--but I have some problems 
similar in Indiana. We just did a meth hearing on Friday, but 
we also just had a major arrest of somebody who--the biggest 
series of bank robberies in the tri-State area I cannot 
remember if it was 20 banks or 30 banks. Some violent bank 
robbers were stealing money to buy OxyContin.
    Also, some of that was not just banks--a few were banks, 
most of them were pharmacies. And they were very violent 
robberies of pharmacies related to OxyContin, which is another 
side thing that is happening if we cannot get doctors to 
prescribe it. But we need to look at this, because clearly this 
has been a big focus. And we have to have focus which I do not 
believe is the case in the law enforcement side, but let us 
just say there is not. I am going to say this as a Member of 
Congress who is perceived correctly as being friendly to the 
pharmaceutical industry, who is friendly to the medical 
industry, who believes that malpractice insurance is already 
driving doctors out of business and unwilling to cover certain 
people, and we have to figure out how to deal with medical 
malpractice.
    But, there is a general perception in the public that to 
some degree the pharmaceutical companies are keeping us from 
correctly and aggressively addressing the subject when it comes 
with a legal drug. And when we are hearing in places like 
Florida, where this is exploded, that we do not even have a 
request on the table for a task force. It is a little 
troubling. Because somewhere in the country--you said you had a 
national task force, but I do not understand it. Some Members--
there is a rumbling in Congress about the concerns about this 
too. And some internal arguing among Members.
    Mr. Raffanello. I believe that in 2004, we do have a 
significant plus something diversion investigators, and what we 
have learned and what we try and do in the field is to try and 
use State and local partners as force multipliers, and we have 
been fairly successful. And that is the reality of it, we do 
not have nor could we ask you for the amount of agents that it 
is truly going to take. So we have formed alliances with our 
police partners and with our State people, the FDLE here.
    The chief in Lake Mary sits on the narcotics and dangerous 
drugs of the International Chiefs of Police. We have been 
working with them to roll these things out. But it takes 
manpower, and it takes a little bit of money, and it takes 
time.
    Mr. Souder. Congressman Mica had the subcommittee in here, 
he mentioned and I mentioned back when we believe it was now 
Speaker Hastert, chaired this subcommittee, because there has 
been a string of heroin overdoses in the school systems in this 
area, like there was in Plano, TX. And at that time there was 
not much focus on heroin. So part of our goal through this is 
to help us focus on this, but it is kind of frustrating. I want 
two other quick things.
    One, to followup on Mr. Keller's question on advertising, 
and marketing, which many of us who are free market are very 
concerned about having restrictions placed on companies and 
their abilities to market. And it is--I am greatly relieved to 
hear about public advertising. But I am unclear a little bit on 
even marketing to doctors and pharmacies. Should there be and 
are there different standards in Schedule II, or is there any 
kind of mechanism internally in FDA that would have DEA and law 
enforcement agencies saying this drug is being abused at X 
level? And what we heard today was no drug has been abused at 
this level, and this is a primary problem. So do we have any 
kind of trigger or should we have a trigger internally that 
says when that happens that there is now a further restriction 
on internal promotion and how that promotion is done? Because 
the inherent conflict in the free market is that somebody wants 
to increase their sales, not decrease their sales.
    Now if there is medical malpractice problems and it is 
going to push up doctors' liability cost if they prescribe this 
drug, and then other patients are paying for it all over the 
place. So, you could even have a contradiction where you have a 
company pushing something that is driving up everybody's total 
health cost, because somebody is promoting something that has a 
higher level of risk. Do we have any current systems that 
restrict or put hard warnings on that are mandatory on the 
company? You mentioned a little black box on the thing, but 
frankly, a little black box on the bottle is not going to deter 
an addict.
    Dr. Meyer. Right. Let me answer that, and I think it is a 
several part answer. First of all, there is no difference in 
the FD&C Act between how we regulate the promotion of Schedule 
IIs versus any other drug, so I think that was part of your 
question there, there is currently no difference.
    Mr. Souder. And even after abuse if there is additional 
warnings, then there is no legal thing we would all be.
    Dr. Meyer. There is no legal; right. We do internally of 
course, especially with knowing what we know about these, but 
even with other Schedule II drugs, we do pay closer attention 
to those in our survey of the marketing practices, than we 
would for drugs with less potential harm if they are misused, 
for instance.
    With regard to the black box warning it is absolutely 
essential, and I made the point during my testimony, that 
labeling informs the marketing, and one of the things that is 
necessary in marketing a drug with a box warning is that box 
warning be prominently displayed in any marketing of it. So it 
is not just on the bottle, it is not just in the package insert 
that the pharmacist throws away, but it is actually a part of 
labeling. And in fact one of the enforcement actions we took 
against the manufacturer back in I believe in 2001, they ran a 
JAMA ad in the Journal of American Medical Association where we 
felt they had not properly displayed those warnings and we took 
action against them and they had to do a corrective 
advertisement to rectify that situation.
    Mr. Souder. We clearly have a new problem in society and 
that is our labeling which is correct in trying to run on TV 
ads and other things. Now you see these TV ads that basically 
say this drug will make you smile more, by the way you can get 
liver cancer or heart disease, die of lung cancer, this and 
this, but you will smile more. And people are becoming immune 
to the labeling, let alone hard addicts, and we are going to 
have to deal with something beyond the labeling because we are 
kind of now not able to distinguish the levels of risk and the 
intensity of risk. And it is a new challenge for Congress.
    Mr. Mica, did you have any additional questions?
    Mr. Mica. Yes, just a couple of quick questions.
    Mr. Souder and I participated in the development of a 
billion dollar drug education program that is now in effect, we 
have had some problems with it and we still are trying to work 
that out.
    Dr. Meyer, you testified that education is important in 
this process. I am wondering, Chairman Souder, if we have a 
disconnect between this program that we helped create and what 
is happening on the streets and in our communities. Do you 
report in any way or recommend to the Office of National Drug 
Control Policy any--do you provide any recommendations in the 
education program based on what you are seeing happening and 
problems out there, because you said education is an important 
part--do you have any working relationship with that program, 
or the director?
    Dr. Meyer. I would have to check to answer that, I 
personally do not know the answer to that. I would be happy to 
get you an answer.
    Mr. Mica. And then the other thing would be from law 
enforcement. Now, you are only within the State and Miami, but 
DEA also, do you know any mechanism they have with ONDCP on 
getting information on what is currently happening to our 
education program, and those that are developing the 
educational message that we are paying a lot of taxpayer bucks 
to get out?
    Mr. Raffanello. We do have an executive DEA agent who sits 
on Director Walters' staff, at ONDCP.
    Mr. Mica. And you feel you are getting adequate 
information, but it does not sound like you are staying up with 
the information if you are from south Florida and we have 12 
doctors on our Medicaid program that are milking the hell out 
of a Federal system, actually participating in the abuse 
problem, that gives me great concern. I have sat on this 
subcommittee longer than anybody. I think when Ed Towns was one 
of the predecessors--we have changed the title slightly--people 
went bananas when we had overbilling of patient's taxi service 
in south Florida, they were milking the billing of the taxi 
service for Medicaid patients. And here we actually have the 
program being used to produce and divert, what is it, Schedule 
II narcotics and our three panelists and it is sort of que 
paso; nobody knows what is going on.
    I am going, when we get to McDonough, our State drug czar, 
head of ONDCP, we will have some more questions, but we need to 
get a little bit better coordination between the agencies and 
also focus on sort of the bad apples in this process. And I 
look forward to the recommendation I have asked for.
    Mr. Raffanello. I am very happy to report I was just told 
by one of my people here that we are a part of the 12 doctor 
investigation. That fact that we were not mentioned in the 
paper really does not surprise me.
    Mr. Mica. Well, what surprises me is that you do not know 
and we do need a better connect. Again, if we can go after 
people who are overbilling for patient taxi service, we sure as 
heck can go after them if they are diverting illegal narcotics 
that are killing our young men and women in the State and 
across the country.
    I yield back, Mr. Chairman.
    Mr. Souder. Mr. Norwood, do you have anything more?
    Dr. Norwood. Just very briefly, Mr. Chairman. And I would 
recommend to you that you see the JAMA ad that Dr. Meyer is 
referring to. My personal opinion was they were--the FDA was 
stretching it just a little bit, but I think it would be 
valuable to you to see, so you can see exactly what they were 
considering a major mistake.
    I have just one statement and I would like to know if you 
guys agree with it. Heroin is illegal in Florida, but heroin is 
your No. 1 problem. If we were to make the manufacture of 
OxyContin illegal, it would still be a problem, it would only 
be a problem at the borders more so than in the pharmacies. It 
would be a problem still on the Internet.
    If we were some way able to stop OxyContin from ever coming 
into this country, then we would again be back to dealing with 
Dilaudid, Percocet, Percodan and things like that. And I want 
to first see if you agree with that statement. Do you believe 
what I just said would be correct? Yes, sir.
    Mr. Raffanello. If we outvote it, I believe it would come 
from outside the country or through the Internet from other 
countries, absolutely, someone would fill the void with all of 
the above. If you could not get it internally, than you see 
other drugs you could get, abused to a higher level to make up 
the difference.
    Dr. Norwood. As it use to be prior to OxyContin.
    Mr. Raffanello. This is not a new phenomenon, people have 
been abusing prescription drugs since we instituted 
prescription drugs. It is just that now there is a lot more 
information out there on it.
    Dr. Norwood. And my concern is that we be very, very 
careful and not take away this, particularly I guess for cancer 
patients in the country. And if you outlaw it totally then the 
patients who actually need it and are using it correctly no 
longer have it available; only those who are abusing it will 
have it available. So all I am saying, Mr. Chairman, is we have 
to be very careful how we handle this problem.
    And I yield back.
    Mr. Souder. I appreciate that, and as we tackle a couple of 
things, it is just like what we had on our meth hearing on 
Friday, and some of our meth hearings are emerging drugs. In 
Indiana, for example, meth has doubled each of the last 4 years 
in a row. And there are ones that are growing, there are some 
that are relatively stable. I think it is fairly safe to say we 
do not have control of the south border yet, and the Carribean 
or the south border.
    But as we think more progress, particularly on things 
coming through airports and through UPS, FEDEX searches and we 
get better control of our borders, which if we are going to 
have homeland security we have to do. Than we have to watch for 
things that we are doing internally as well, that they do not 
become a replacement. So if in fact we are successful in 
pushing Afghanistan and Colombia on the heroin question, that 
we do not have methamphetamine and then OxyContin replace those 
drugs of choice. And think ahead 3 to 5 years or 10 years. We 
also ought to at least have the social stigma on something that 
is dangerous and make sure, because part of what happened, like 
what is happening on so-called medical marijuana which is a 
substance inside marijuana that if you get something that is an 
illegal drug labeled as a good drug it becomes much harder. And 
what we have to do is separate it in the case of some of these 
things, that they are controlled, that only under managed use 
can you get them.
    And what we are debating here is something that was widely 
spread that is now becoming more tightly managed and how, as a 
society, do we rein it, when at the very beginning we did not 
understand the nature of the risk, as I understood. That still 
has a huge benefit in this case and in high risk case, and we 
are going to face this and more. But if we are successful in 
border control, we have to watch about the replacement.
    I thank each of you for your testimony. We will have some 
additional written questions. If you want to submit anything 
else for the record, feel free to do so.
    If the second panel could now come forward. The second is 
the Honorable James R. McDonough, director of the Florida 
Office of Drug Control; Dr. Stacy Berckes, Board Memeber, Lake 
Sumter Medical Society; Mr. Jack E. Henningfield, Ph.D., Pinney 
Associates, on behalf of Purdue Pharma; Ms. Theresa Tolle, 
president of Florida Pharmacy Association. Mr. Mica.
    Mr. Mica. Mr. Chairman, while the next panel of witnesses 
are being seated, unfortunately the Honorable Burt Saunders, 
the State Senator, District 37, and chairman of the Florida 
Senate Committee on Health, Aging and Long Term Care, because 
of another emergency situation is not able to be with us today. 
He has notified the subcommittee. So I ask unanimous consent 
that his entire statement be made part of the record.
    Mr. Souder. Without objection, so ordered.
    [The prepared statement of Mr. Saunders follows:]
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    Mr. Souder. If each of the witnesses will raise their right 
hands.
    [Witnesses sworn.]
    Mr. Souder. Thank you, let the record show that each of the 
panelists replied in the affirmative.
    Thank you for coming today, we really appreciate you 
helping us clarify this issue. We are going to start with Mr. 
McDonough, I keep wanting to say the regional drug czar, so I 
thank you for coming today.

 STATEMENTS OF JAMES R. MCDONOUGH, DIRECTOR, FLORIDA OFFICE OF 
   DRUG CONTROL; DR. STACY BERCKES, M.D., BOARD MEMBER, LAKE 
  SUMTER MEDICAL SOCIETY; JACK E. HENNINGFIELD, PH.D., PINNEY 
  ASSOCIATES, ON BEHALF OF PURDUE PHARMA; AND THERESA TOLLE, 
         R.PH., PRESIDENT, FLORIDA PHARMACY ASSOCIATION

    Mr. McDonough. Mr. Chairman, thank you very much for having 
me and for holding this hearing. On behalf of Jeb Bush, the 
Governor of the State of Florida, he extends his greetings and 
his appreciation for what you are doing.
    And to Mr. Mica, sir, thank you very much for your 
suggestion that the hearing be held, it is always an honor to 
appear before you.
    And sir, welcome from Georgia, very good to have you down 
here. I live only about 12 miles from your State and I love it 
because I can go up there and get my gas at about 20 cents a 
gallon cheaper.
    I have submitted a statement for the record, I would like 
to sum up that statement, in just a very few minutes if I 
might, Mr. Chairman.
    I think there has been adequate discussion of the scope of 
the problem. I would just add a couple of things that we have 
noted. In addition to the theft of prescriptions through the 
thefts of the pharmaceuticals themselves in resale, in addition 
to the Internet sales which we think is a major problem and to 
the doctor shopping, what I call pharmacy hopping, and finally 
in addition to the corruption we have a small amount but some 
in the system itself. We also have uncovered a great deal of 
recipient fraud in the State of Florida, and diversion at the 
far end, such as in nursing homes for those for whom the drugs 
are intended. They do not get them, and are often unaware of 
that and unable to report it.
    Florida does have a large problem with this, I do have 
oversight on the extent of the problem and the problem I am 
talking about specifically is prescription drugs, the abuse of 
them and that is all of them. Much has been said this morning 
on OxyContin. As we are able to track this it is oxycodone the 
chemical compound in OxyContin and other drugs that we really 
keep track on, but when we combine them with the hydrocodone 
and the methadone, we come up with an aggregate that led to a 
greater death rate than heroin and cocaine.
    So from my perspective, prescription drug abuse has become 
the greatest killer in the drug world in this State, and that 
is an enormous amount. There are, as you know, and you will 
hear later from the mothers and fathers of some of those who 
have died in this room. I hear from them and count the total 
loss as 10 a day. If we look only at the abuse of prescription 
drugs, devoid of any other illegal drug abuse, it is five 
killed per day. Unacceptable, an epidemic of first proportion. 
I might add what is really unnerving about this in addition to 
that grotesque death rate is the rate at which it is rising. So 
we only began tracking them in Florida in 2001, and every year 
we saw it go up 25 to 30 percent. I do believe we have the rise 
in the death rate stopped this year but it is still far too 
high. We are on track in 2003, to come in slightly above the 
numbers that we had in 2002.
    So the scope of the problem is vast, it is steep, and very 
complex. Governor Bush had directed a series of very aggressive 
actions that will address it. I would just like lay out the 
breadth of that briefly.
    First of all, we would appreciate, all the help we can get 
from our friends at Federal level, and I know all the people 
that testified before, admire them all, but I think we have to 
work harder on this particular problem.
    ONDCP and the National Institute on Drug Abuse points out 
that the second most abused drugs in the United States now 
after marijuana are prescription drugs. That is an enormous 
event, it tells me it is the new wave of drug abuse. In the 
history of drug abuse in the United States, there is always a 
new way: it is cocaine, it is crack cocaine, it is 
methamphetamine. Today it is prescription drug abuse, and by 
the way, methamphetamines have not gone away so we still have a 
problem with that. But it is a serious problem.
    We are looking at law enforcement as a way to get at this 
problem, and although it did not come out clearly from our 
Federal friends, who are helping us, I will tell you the State 
of Florida is getting very aggressive in going after any 
corruption in the system. So, all of the doctors and I do not 
know the names of the ones specifically referred to in that 
article, but I do know that we are looking at where we believe 
there is an element of corruption and we are going after that. 
Not just for doctors, but for the pharmacies as well.
    We also have, as I said, a major recipient fraud problem, 
which is not a light problem. A recent statewide grand jury 
investigation indicated that it could be a significant percent 
of the Medicaid system in the State and the Medicaid system in 
the State is something like $13.5 billion. But law enforcement 
I have to point out is not enough by itself, it comes in after 
the fact, after people have died. So we are looking at early 
warning systems that will allow us to detect early through 
Medicaid and other data mining sources that we have a problem.
    And we are also looking at process, the process that allows 
the administrator that oversees the system, whether it be the 
distribution of pharmaceuticals, the use of Medicaid, passes 
that off to the appropriate investigative authority when we 
believe we could have an instance of fraud and abuse and 
diversion. It is also the education of doctors. We find that 
many doctors do not have adequate identification capability of 
addiction, as well as the pharmaceuticals themselves. So, we 
are looking at requiring a greater effort to educate our 
doctors. And certainly we need to inform the public of the risk 
of prescription drug abuse.
    So, it is the entire process that we will get at early 
warning, law enforcement, training, and education, and finally 
a legislative packet within the State that will allow us to 
deter the event for the most part before it happens. I will 
tell you that the prescription drug validation system we are 
looking at all by itself will go a long way to stopping the 
grotesque death rate we are going under. It will not completely 
stop it, but it is the single most important thing we can do. 
It is that package of events in combination with what the 
Federal authorities can do that I think would help us bring 
this problem under control.
    Thank you, sir.
    Mr. Souder. Thank you, very much. Doctor, is that Berckes, 
next.
    [The prepared statement of Mr. McDonough follows:]
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    Dr. Berckes. Mr. Chairman, I would just like to clarify my 
credentials, in addition to on the witness I am identified as a 
member of the Board of Governors of the Medical Society, and 
indeed it is via that mechanism that I was invited, but, I 
think it is important before I give my testimony that it is 
understood that I am also a Board certified anesthesiologist 
and pain medicine practitioner. My practice is in Florida Pain 
Management Center, and additionally that I am the chief of 
staff at Florida Hosptial, Waterman.
    Since there was not an opportunity, and if you thought it 
was beneficial for the record I will certainly attach my CV to 
the written testimony if you thought that was useful.
    Mr. Souder. It is always helpful to have any extra 
information about the witnesses.
    Dr. Berckes. Thank you for allowing me to clarify that.
    ``First do no harm.'' Those words, from the Hippocratic 
Oath, take on special meaning when discussing the topic of drug 
use and abuse. I speak to you today with almost 20 years of 
experience practicing medicine, the majority of those years 
treating acute and chronic pain. I agreed to testify because I 
feel strongly that being on the front line of an issue offers a 
unique perspective to those interested in directing substantive 
public policy.
    These proceedings are being followed by many that have been 
touched in one way or another by this issue. To those that have 
lost loved ones, I extend condolences. As painful as it may be 
we must learn what we can from each and every failure to best 
serve those with needs in the future. Simply banning a drug 
that has demonstrated usefulness is not an option.
    To the pharmaceutical companies that may have an interest 
in these proceedings, let me say, keep your science pure. 
Continue efforts to provide true continuing education so we can 
best serve our patients. Attempts to manipulate data and words 
for the sole purpose of creating demand and increasing sales 
will ultimately fail. Do not promote the mindset that there is 
a pill for every ill.
    To the patients that suffer chronic pain, please know that 
efforts continue to increase the quality of your lives. We 
understand now more than ever before about the neurophysiology 
of pain, the pain signal, pain generators and the pain process. 
This understanding has resulted in many more treatment options 
than ever before. The use of narcotic analgesics is just one of 
the tools that may be useful.
    In my practice lifetime, I have seen the pendulum swing 
from one end of the spectrum to the other with respect to the 
use of narcotics. In the 1980's, I had to regularly defend this 
practice and now I am having to recommend against it with 
almost the same regularity. Every patient deserves to be 
evaluated and treated as an individual in a way to be 
determined by his or her physician. Many things cannot be 
cured. Pain as a symptom is handled differently from pain as 
the disease State, which often, at best, is managed. True pain 
management is a dynamic process that demands continuous 
communication between a patient and the doctor.
    To the pharmacists who fill prescriptions, I urge you to 
adhere to the highest level of your profession's ethics, and do 
not hesitate to question prescriptions that appear irregular. 
The system of checks and balances only works when active 100 
percent of the time.
    To my colleagues, you know that you are responsible for 
knowing the possible consequences, benefits, risks, and 
complications of any prescription you write. There is no 
substitute for the history and physical examination. The issue 
of diversion of legitimate prescriptions is an area in which we 
are not formally trained, but one in which we always must 
maintain a high level of suspicion when we are prescribing 
drugs with known street value. The judicious use of urine or 
serum screening to document compliance of a treatment regimen 
probably needs to be increased. Additionally, understanding the 
differences in abuse, addiction, tolerance and dependence is 
required for appropriate communications with patients, 
caregivers, as well as other colleagues and law enforcement 
individuals and officials.
    With respect to public policy, I can only say that there is 
no way to legislate judgment. This is particularly true to the 
problem at hand. There are already laws that cover 
inappropriate obtaining, use, and possession of controlled 
substances. There are already laws that cover the inappropriate 
practice of medicine and pharmacy. There are already laws that 
cover what a drug company can say or do. Additional laws in 
these areas will probably not result in any substantive change 
in the status quo. Additional funding in specific areas to 
enforce laws already on the books may help.
    The data base that has been discussed may have merit but 
the details about the design, construction, implementation, and 
ongoing costs have not been forthcoming. Anything that makes it 
more difficult for doctors to take care of patients is 
unacceptable. The availability of controlled substances via the 
Internet is one frontier which probably deserves additional 
legislation.
    Finally, the unfortunate truth is that there are, always 
have been, and always will be people with the genetic makeup 
that fosters drug abuse and the black market that feeds it. Any 
system that man creates will be circumvented by man. So let us 
be cognizant of the law of unintended consequences when we try 
to make anything better.
    Perhaps our greatest hope lies in the continued discoveries 
of the human genome project, that will let us understand the 
more complex areas of opiate receptors, and why people react in 
such varied ways to the same drug. Meanwhile, there is no 
better cure for the present situation, than a true 
understanding of the existing science, and an ongoing doctor/
patient relationship.
    Thank you.
    Mr. Souder. Thank you for your testimony. Next we go to Dr. 
Henningfield.
    [The prepared statement of Dr. Berckes follows:]
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    Mr. Henningfield. Thank you for the opportunity to testify 
on the challenges posed by prescription drug abuse. I am a 
professor at the Johns Hopkins Medical School where I direct 
the Innovators Combatting Substance Abuse Awards Program. I am 
also, vice president for research and health policy at Pinney 
Associates, which is a science and health policy consulting 
firm.
    We assist Purdue Pharma and other companies seeking help in 
identifying factors contributing to prescription drug misuse, 
abuse, diversion and addiction. We help develop strategies to 
reduce such unintended consequences while enabling appropriate 
medication use and access. I am representing Purdue Pharma to 
offer recommendations on this topic. The issue is important to 
me and it is to Purdue Pharma. The consequences of abuse and 
diversion of medications are serious for the people who abuse 
drugs, and the consequences are serious for the million of 
people living with pain. I have several observations and 
recommendations that I hope will help you. My written testimony 
provides these in much greater detail. There are no simple 
solutions, I think we have all said that, and I agree heartily.
    Prescription drug abuse is a complex historic and evolving 
public health problem. The modern history of pain reliever 
abuse in America may be traced to the Civil War when the 
syringe revolutionized the treatment of pain, but also led some 
to develop addiction to the opioid drug morphine. It was than 
called ``soldier's disease.'' Our Nation has struggled to find 
the right balance between medication access and control ever 
since. The history of substance abuse also reveals that the 
cycles are rarely anticipated and not readily controlled. For 
example, cocaine went from a small blip on our radar screen in 
the 1970's to our Nation's major drug of concern in the 1980's. 
Opioids such as heroin increased in the 1980's, in the 1990's 
prescription opioid abuse increased undoubtedly due in part to 
the perception that they were safer and less addictive than 
street drugs.
    It is clear that drug abuse and diversion go far beyond the 
chemistry of the drug. My first chart shows data from the major 
Federal survey that measured non-medical use of opioid pain 
relievers by brand names. The short bar on the left side 
represents OxyContin. I show these data to illustrate the 
diversity of drugs that are abused and the complexity of the 
challenges facing us. As you may surmise and has been stated 
several times today, drug abusers have lots of choices and 
history tells us that when they are denied one drug they 
quickly turn to another.
    Such surveys provide a general picture of the substance 
abuse landscape, but they have many shortcomings compared to 
the data that we rely upon to track outbreaks such as 
influenza, West Nile virus, and hepatitis. In fact the December 
GAO report on prescription drug abuse acknowledged these 
limitations concluding, ``Current Federal surveys do not 
provide reliable, complete or timely information that could be 
used to identify abuse and diversion of a specific drug.'' 
Accurately estimating the numbers of deaths, and correctly 
attributing their cause is also critical to developing efforts 
to prevent future such deaths.
    I would like to show a second chart from the 2003 Florida 
Medical Examiners Interim Report of drugs identified in 
deceased persons. Some of these data have been discussed today. 
This chart shows the frequency of association of various drugs 
with deceased persons. Alcohol was associated with the greatest 
number at 31.7 percent, then benzodiazepines at 16.1 percent 
and cocaine at 14.6 percent. All oxycodone medications combined 
were associated with 5.6 percent. While this chart implies 
straight forward relationships between drugs and deaths, the 
reality is not so clear, as evidenced if you look at the report 
in detail. Determining the actual cause of death for any of 
these drugs is complicated and in many cases multiple drugs 
were evident.
    Another study found that 97 percent of drug abuse deaths 
contributed to oxycodone drugs actually involved several drugs. 
In discussing these statistics I must state that any death from 
drug abuse is tragic, but as we seek solutions we must 
understand the problems well enough to develop solutions that 
will actually work to prevent such tragedies in the future.
    Another complication in understanding drug abuse trends is 
that abuse of single drugs by individuals is rare. For example 
the overwhelming majority of persons who used OxyContin non-
medically in a Federal survey had abused at least two other 
analgesics and/or illicit drugs of abuse, such as heroin, 
cocaine, and marijuana.
    Let me wrap up by mentioning six key recommendations that I 
believe could contribute to a comprehensive solution: First, 
address deficiencies in our drug abuse monitoring system that 
were describe in the GAO report. We need accurate and timely 
information. Second, provide education at all levels of society 
about the dangers of prescription drug abuse. Third, nurture 
community partnerships as advocated by President Bush in his 
State of the Union Address. Fourth, strengthen our drug abuse 
treatment system so that people who develop addictions can get 
treatment that matches their needs when they need it. Fifth, 
encourage the development of comprehensive risk management 
programs for controlled medicines as recommended in the GAO 
report as well as by FDA and DEA. Finally, we need to address 
gaps in the drug control effort opened by unregulated Internet 
sales.
    So, in conclusion, let me emphasize that prescription drug 
abuse and diversion is an important public health problem that 
warrants increased attention. There are no simple answers. As 
we move forward in search of strategies to deter abuse and 
reduce diversion we need to recognize the needs of people in 
pain as well as the health care professionals who treat them. I 
believe that these actions need to be part of a comprehensive 
solution to the problems of prescription drug abuse.
    Thank you for the opportunity to testify.
    Mr. Souder. Thank you for your testimony, and we will make 
sure your entire written testimony appears in the record, and 
if you have additional materials too.
    Ms. Theresa Tolle, is it Tolle.
    Ms. Tolle. Tolle, it is Tolle, yes.
    Mr. Souder. President of the Florida Pharmacy Association.
    [The prepared statement of Dr. Henningfield follows:]
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    Ms. Tolle. Thank you, for the opportunity to be here today. 
I am Theresa Wells Tolle, I am a pharmacist and I am co-owner 
of Bay Street Pharmacy, which is an independent pharmacy in 
Sebastian, FL. I am the president of the Florida Pharmacy 
Association, and today I am here representing the American 
Pharmacists Association. APhA represents more than 50,000 
practicing pharmacists, pharmaceutical scientists, student and 
pharmacy technicians. And we are the largest national 
association of pharmacists in the United States.
    APhA welcomes the opportunity to present the pharmacist's 
perspective on the abuse of prescription drugs, including 
controlled substances. As the medication experts on the health 
care terms, and the health professionals dedicated to 
partnering with patients to improve medication use, we 
appreciate the opportunity to discuss the importance of 
striking a balance between providing effective, legitimate, 
appropriate health care and preventing prescription drug abuse 
and diversion.
    Prescription medications are safe and effective when they 
are used appropriately, and pharmacists are the health care 
providers who work most closely with patients to make certain 
patients use their medications appropriately. Prescription drug 
abuse is one type of medication misuse, misuse that we as 
pharmacists try to prevent. Pharmacists work collaboratively 
with prescribers to prevent the diversion of prescription 
medications and to identify incidents of abuse or addiction. As 
part of this process, pharmacists assess the appropriateness of 
every prescription order they review or dispense. I watch for 
individuals who attempt to fill fraudulent prescriptions, who 
are visiting multiple prescribers, or present prescriptions for 
unusually large quantities of medication. Every day, I assess 
the validity of prescriptions, by watching for errors in the 
content or the format of the communications. However, it is not 
always easy to determine if a prescription is legitimate, and I 
cannot view every patient as a potential drug abuser without 
compromising my responsibilities as a health care provider.
    Identifying potential drug abusers is an area where 
collaborations with regulatory agencies makes sense. For 
example, the Florida Department of Health recently barred one 
of Florida's most prolific Medicaid prescribers from issuing 
any more prescriptions for controlled substances. Having either 
the Florida Board of Medicine or the Department of Health 
provide this information to the pharmacist community would help 
educate pharmacists about potentially illegitimate 
prescriptions.
    Another area of collaboration between regulatory 
authorities and pharmacists is now occurring in my own 
practice. The narcotics detective of our local Sheriff's 
Department informs pharmacists about potential drug abusers as 
well as when a local prescriber's prescription blanks have been 
stolen. They do this with a fax alert. These efforts help 
pharmacists determine whether a prescription is legitimate. In 
both of these examples, the regulatory authorities are helping 
pharmacists by providing them information. However, in both 
examples the pharmacist has the final say in whether or not the 
prescription is for legitimate purposes, a determination they 
must make for every prescription presented to them.
    APhA supports efforts to strike the balance of reducing 
prescription drug abuse and diversion, but without restricting 
patient access to drugs. In October 2001, APhA, in 
collaboration with 20 other health care organizations and the 
DEA, released a joint consensus statement on the need to 
prevent abuse of prescription medications, while ensuring that 
they remain available for patients in need.
    Focusing on the subset of medications known as opiate 
analgesics, the groups recognized that for many patients, 
opiate analgesics are the only treatment option to provide 
effective and significant pain relief. However, a narrow focus 
on the abuse potential of a drug could erroneously lead to the 
conclusion that these medications should be avoided when 
medically needed, generating a sense of fear rather than 
respect for their legitimate purpose.
    We caution against efforts to restrict the distribution of 
certain medications or arbitrarily limit health care providers' 
ability to prescribe or dispense appropriate medications. With 
every barrier erected to limit diversion, the potential for 
those barriers to diminish appropriate prescribing increases 
exponentially. Reduction in the drug distribution process can 
delay access to medication therapy, and disrupt existing 
patient-pharmacist-prescriber relationships. Additionally any 
stigma attached to the drugs will have a significant chilling 
effect on health care providers' willingness to prescribe and 
dispense appropriate medication and patients' interest in the 
medication.
    In a survey conducted by New York State's Public Health 
Council, 71 percent of physicians surveyed reported that they 
do not prescribe the most effective pain medication for cancer 
patients, if the prescriptions require a special State 
monitored prescription form for controlled substances, even 
when the medication is legal and medically indicated for a 
patient.
    Efforts to limit abuse and diversion should be developed in 
collaboration with health professionals and consumers and 
designed for maximum benefit and minimum intrusion. State level 
tracking systems when well constructed can provide this 
benefit, and well constructed programs provide prescribers and 
pharmacists with relevant timely information about dispensed 
medication. We cautiously support efforts to heighten 
regulations in this area. Federal enforcement agencies such as 
DEA should continue to be a law enforcement agency fighting the 
illegal diversion of drugs. But the DEA should not be turned 
into a medical oversight body. Drug therapy should be managed 
by health care professionals.
    The very threat of regulatory intervention and oversight 
and the fear of having their intentions misconstrued could 
dissuade physicians from using aggressive efforts that are 
often needed to use medications effectively.
    It is important that patients do not lose access to 
medications because of a failure to prevent medication misuse. 
Solutions must not have a chilling impact on the effective drug 
therapy management. The solution requires the education of 
health care professionals, law enforcement personnel, and the 
public on the use and abuse of prescription medication.
    APhA, and its members are committed to working with 
Congress, the FDA, the DEA, and other health care providers and 
patients to find the appropriate balance between appropriate 
medication use and measures to curb the abuse and diversion of 
prescription drugs.
    Thank you, for your consideration of the views of the 
Nation's pharmacists, APhA, looks forward to working with the 
committee to develop a safer and more effective system of 
providing prescription medications to all Americans.
    [The prepared statement of Ms. Tolle follows:]
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    Mr. Souder. Well, I thank you each for your testimony. And 
I want to say up front, which you heard me say in my first 
panel, I really did not come into this hearing with much of a 
preconceived notion. I have seen some of the headlines in my 
own district. We focused on a lot of other issues and so I was 
not as knowledgeable as Mr. Mica or Mr. Norwood in the 
particulars. And among other things Eli Lilly, is a major 
player in Indiana and I have been a strong supporter of Eli 
Lilly. In the interest of full disclosure I have 
anesthesiologists and all sorts of different doctors on my 
finance committee, because when we ran for office in 1995 there 
was a lot of outrage about the nationalization of health 
insurance and so I am disporportionately hooked up with them.
    Medical Protective, one of the largest malpractice insurers 
for doctors is based in my district, along with General 
Electric. But I am frustrated by your testimony. I have been 
getting the crap kicked out of me, with all do respect, for 
working too much with the medical industry. If the medical 
industry cannot understand the difference of a drug epidemic 
and wants to stand behind the shield of do not intervene, we 
are going to do some nice compromises in a drug epidemic, you 
bring a lot of the pressures on yourself.
    I do not like a lot of what we in Congress passed in HIPAA 
regulations. I am tired of all the paperwork on every little 
thing, why can we not prioritize. OxyContin, right now is a 
priority type of thing, or the underlying thing underneath it. 
It is not aimed at Purdue Pharma, it is not aimed because it 
can spread. But let us lay a couple of things out in the record 
here. The difference between a heroin dealer and a cocaine 
dealer, is you are not them. You are dealing with prescription 
drugs that are paid for mostly by other people. One difference 
is that is the Federal taxpayer as an individual taxpayer do 
not pay for cocaine and heroin. There is a ethical difference 
when you ask the Federal Government, the State government, and 
other taxpayers to subsidize somebody's habit. That is going to 
bring additional pressures on that.
    Second, that when the network is a legal distribution 
network that is approved by society, that it is going to bring 
different pressures on it. Now, it is absolutely true that the 
anesthesiologists, and people who understand pain reduction 
have to be primary players at the table, and that pharmacists 
cannot assume that everybody coming in there is a criminal. I 
appreciate that statement. On the other hand, when you have an 
epidemic in the community and when small town pharmacists are 
being held up at gunpoint in my district, and that in fact a 
fair number, which has not been established what percent, are 
in fact criminals who are doing it. It suggests that you are 
going to have to use a little more discretion. There is going 
to be some regulations with it, or what is going to happen is 
the entire pharmaceutical industry, the entire flexibility of 
the medical community is going to be taken away because the 
general public is not going to tolerate their money being 
spent. Which is different than cocaine and heroin. I am not 
arguing here that it would not move to something else, but we 
have the obligation as stewards of the taxpayers' dollars, to 
at least make sure our dollars are not being used this way. To 
make sure that those who are in legal trade are not. I am 
particularly outraged at the statement that 71 percent of the 
doctors in New York State would say that they would not 
prescribe what is best for their patient based upon on a 
paperwork decision. And quite frankly, that leads us into a 
question of should their malpractice insurance go up.
    In other words, maybe one of the ways to do this is to have 
a different criteria on the people who do not prescribe because 
they do not want legitimate paperwork. And to me, part of our 
responsibility in oversight is we have dumped so much 
illegitimate paperwork, chasing at the margins on the doctors, 
and quite frankly, by not controlling the lawsuits all the 
time. Because you can be harassed for everything, and that is 
part of the concern here. That sometime this could lead to a 
bunch of lawsuits on the drug company, on the pharmacist, or 
the doctors which is outrageous. The problem is we need to take 
responsibility how to address this, get control of the lawsuit 
question, but that should not prohibit us from trying to 
address legitimate concerns in that.
    We can make some progress as we talked about here which you 
all have supported, but the underneath is what has caused me to 
erupt here as a friend, and say, look, this is different. What 
we are looking at is an epidemic, and if we do not try to treat 
epidemics like this, that our whole support system for not 
cracking down and having national socialized medicine system is 
going to collapse.
    Because if we do not go after the bad guys aggressively and 
target those higher risk groups first and foremost. And we do 
not have a mechanism to identify those high risks. In other 
words, if you will not help us go after the highest risk areas, 
then everybody will become a suspect. And then there will be 
non health regulation by DEA in the pain relieving medicine. 
This cannot be kind of like a slap on the wrist and we are 
going to put a little warning up here and so on, because it is 
not going to work. The outrage of the community already over 
the general cost of prescription drugs, the general cost of 
health care is so large that we are walking on a very tight 
wire now. And having this kind of thing on the top of the other 
pressures on health care is going to bring consequences far 
beyond whether we tinkering around with OxyContin.
    When we have an epidemic erupt we need everybody working 
together and saying we are going to focus on this right now. I 
would like to hear some of your reactions to that. Who wants to 
start.
    Dr. Berckes. I cannot speak to the 71 percent that was 
mentioned earlier and I hear and I understand from your 
perspective as well. The majority of the physicians that I have 
spoken to with respect to this issue when it became clear that 
I was going to be the one to talk about this today is that 
doctors do not want to have tools taken away that can help. And 
indeed I can tell you that the percentage of physicians that 
are responsible is very small.
    I think we heard testimony about that, things have been 
published already. But I can also tell you the frustration from 
the point of view of a physician that cooperates with the 
Florida Board of Medicine in looking at these outrageous cases 
and what has to be done and the hoops that have to be jumped 
through to pull their license. OK, looking at records and I 
have cooperated with the board and I am glad to do that. There 
is not a lot of pain management physicians that have the 
qualifications and that are volunteering with that, and it 
takes a lot of time.
    I have seen things and it is just beyond me how a doctor 
can get away with it for so long. The only thing is and I think 
Representative Norwood, brought this up earlier, it must be 
that the pain that they are going to incur is very small to the 
possible benefit. They are not going to hurt enough and it is 
not just taking away their license to practice medicine, but it 
is throwing them in jail, and I do not think it has been done 
enough, and I have seen enough and it makes me sick. But we 
apparently have a process that protects those that are causing 
the problems. And much more, it is much more of a problem than 
probably we suspected before.
    When somebody walks into a pharmacy and presents a 
prescription for 540 OxyContin 80 milligrams month after month 
after month, there is something wrong with the whole process: 
where that originated, who is filling it, the whole thing. I 
mean it is just mind boggling. We do not want these tools taken 
away, and we know that they will be, and we are sensitive to 
the health care dollar. The health care dollar be it Medicaid, 
the future Medicare prescription benefit, we do not want this 
taken away, and we support any efforts that may enable the 
situation to get better.
    Organized medicine supports this, please do not 
misinterpret anything I have said. We just do not want to go 
back to having our hands tied behind our backs, OK. The 
evolution of the speciality of pain medicine has been a 
relatively new one. And I believe patients are being served 
better, whether it is cancer patients or other non malignant 
type of pain, non-cancer pain. And at least what I see in my 
community is that there is less use of certain of these drugs 
by primary practitioners, and they are allowing the people with 
specialized knowledge to make the calls on this. And whether 
that is something that is a statewide trend or a nationwide 
trend, we have been led to believe because of the proliferation 
of pain management specialists that is happening. But when you 
see things like these incredible numbers of OxyContin being 
prescribed by small numbers of doctors one has to believe.
    So, the one area that I am frustrated with as I have tried 
to think has to do with this Internet thing. I mean every time 
I turn on my computer and answer my e-mail I am offered all 
kind of things. I mean I do not know how that is regulated but 
that is a problem that I do not understand. Having a data base, 
a computer data base, is something I think certainly can help. 
But who pays for this. The money in the pie for health care is 
already smaller or at least relatively smaller because there 
are more people that we have to take care of with the same 
amount of money. So, who is going to pay for that system.
    And I have seen things--you know, if we include oxycodone, 
just Schedule IIs but we do not include Schedule IIIs, we have 
shot ourselves in the foot. I mean, I can tell you, using 
hydrocodone is just as risky as using oxycodone.
    I mean there is--and for the people who abuse it is the 
same thing. Why one is a II and one is a III, I am sure there 
is some interesting history about that, but if it is 
comprehensive I think we all can probably get a handle on it. 
But we have these issues of HIPAA that we are all dealing with 
HIPAA right now, and I do not know which way I am going with 
HIPAA. I know I am afraid of violating laws with HIPAA, and I 
do not know how that would equate. But we should be able to 
with the resources of the Federal Government, the United 
States, be able to coordinate with those areas that are 
mandated by each State, to get a handle on this thing really 
quickly.
    I firmly believe that and I pledge my support.
    Mr. Souder. Probably, having to list our peyd when we go to 
the doctor is a over-regulation of HIPAA. That is the way it 
seems sometimes.
    Ms. Tolle. Dr. Berckes, did a great job in covering on a 
wide topic in a short period of time. I think definitely--one 
of you mentioned earlier an umbrella organization with the 
Federal Government, and then State control of that umbrella 
organization. To me that makes the most sense. Colonel 
McDonough said that there is controlled substance monitoring 
legislation that is proposed in Florida and I know there is in 
other States, I believe 18, there may be more, that currently 
have that kind of system in place.
    I think if you can get something like that in place where 
at least you have an ability to look and see who is doing this, 
who is prescribing, the patients who are abusing the system. 
Yes, I have concerns with HIPAA and privacy violations, but I 
also, think at least there is an ability for us to know. There 
is a way for us to, a place for us to go to. We have groups 
like the Florida Department of Law Enforcement, who could be 
the coordinating group for that in the State of Florida.
    As I mentioned, were are very fortunate in my county, 
because I have a Sheriff's Department that is very proactive, 
and they work with us and that works very effectively. I had a 
doctor who was closed down Monday a week ago, their controlled 
substance ability--or his ability to write controlled substance 
prescriptions was taken away from him. I knew that within 2 
hours of that happening, because my local law enforcement 
agency let us know that. At the same time a pharmacy was robbed 
in our area, and we knew that as well, we also knew that the 
pharmacist recognized the suspect and that person was being 
questioned. Which kind of helped us breathe a sigh of relief 
that perhaps he was not coming to us next. But I think those 
types of coordinating efforts are very helpful. And I see that 
as an opportunity for us to move forward and solve this 
problem. I can tell you that there are people out there who are 
writing those 540 tablets of OxyContin, and unfortunately there 
are pharmacists who are filling them month after month, and 
there should be penalties. We need to make sure that those 
people are afraid, that they are going to be penalized.
    Mr. Souder. This is also happening in meth, where we had 
one case where one of the biker gangs that have been developing 
a network of meth labs went to pharmacy training and got 
control of a pharmacy. And we have to be able to weed out the 
at risk groups so that we can keep the harassments down on 
legitimate pharmacies. To do that there has to be cooperation 
and information. Dr. Henningfield.
    Dr. Henningfield. Congressman, I agree with everything you 
said. I think that we do have a serious problem with 
prescription drug abuse, and we do need to address it.
    I have a couple of suggestions, I would like to keep an 
image in mind, and the image is a balloon. And what we have to 
be careful is that we do not squeeze the balloon in one place 
so it pops up in another place, because that is what happened 
over decades with drug addiction.
    We have some serious problems in our infrastructure, our 
monitoring system. We would not tolerate a CDC that told us a 
year or two after the fact when there was a new virus or 
epidemic, or hepatis outbreak. We expect comprehensive rapid, 
reliable monitoring for drug abuse. We have that for other 
diseases. We have made a lot of progress, I think the 
institutes have made a lot of progress, but if Congress further 
prioritizes this I believe that SAMHSA and other Federal 
agencies could do a better job and do a better job of 
integrating local information with Federal information as the 
CDC does.
    Monitoring deaths and correctly attributing them is 
critical. The Florida Medical Examiners report, if you look at 
it in detail, you see that ascertaining actual cause of death 
is a complex business. Yet, as CDC knows with other diseases, 
you have to do that if you are going to fix the problem and 
prevent it in the future. We need a better, more systematic way 
of doing that.
    The Internet is a hemorrhage, I do not know how to fix it. 
Prescription drug monitoring is a national system and a local 
system, that allows doctors to find out, how does this 
integrate them with our Federal monitoring systems. On 
treatment, our former surgeon general Dr. C. Everett Koop, he 
said, ``it is easy to get addictive drugs, it is hard to get 
treatment; as a Nation, our challenge is to reverse this.'' 
That is a fact right now, and that means when people do get 
into trouble and they will get into trouble; no matter what we 
do, there will be some people in trouble. They have to have a 
place to go when they need it, and it has to be the right kind 
of treatment, and the one thing that has not been discussed 
directly today is also a conclusion of the GAO report and FDA, 
and DEA, and that is the concept of risk management 
programming.
    The whole idea is the Controlled Substance Abuse Act came 
about when a lot of these problems were not on the radar 
screen. It took a simplistic approach, it is basically the 
chemistry. My laboratory at NIDA studied mainly the chemistry, 
and addiction potential. Now, we know it is much more than the 
chemistry. The concept of risk management programing and plans 
is that you a, identify all the potential risk associated with 
the drug; b, you develop solutions to the best of your ability 
to minimize those risks and still maximize the beneficial 
effects of the drugs.
    Then you should have a monitoring system in place to fix it 
if it does not work. And if you do not have all that, you will 
have problems and they will recur and recur and recur. You 
could take the top 10 drugs of abuse, licit or illicit, off the 
market, ban them, and they would be replaced. You would just be 
squeezing the balloon in one place. So, I urge you to consider 
a comprehensive solution. There are things that you can do.
    Mr. Souder. Mr. McDonough, do you want to comment on this?
    Mr. McDonough. Mr. Chairman, very briefly, I could not 
agree with you more, the death rate is obscene. We do have to 
take steps and have to take strong steps immediately. We cannot 
hide behind the excuse that we have to be very careful as we go 
forward--it is an epidemic, as you said. When you are dealing 
with an epidemic you have to take immediate action.
    I would point out the validation system in the 18 States 
and the one we expect to put into place in Florida, is most 
used not by law enforcement, but by doctors. Doctors want to 
know what their patients are being prescribed, only then can 
they give good medicine. And since we have worked very closely 
with the Florida Medical Association as well as with the 
pharmacy folk, we know for sure that neither group tolerates 
murderers in their group. I will point out that Florida has 
been very aggressive in going after this from a law enforcement 
perspective and in identifying the extent of the problem.
    That means, therefore, we get a lot of press on this. I 
suspect that these problems exist throughout the country, but I 
know that is why you are looking at it. Here for the purpose of 
addressing the issue for the entire Nation, and I laud you for 
that.
    I also wanted to point out that it is very easy to play 
with data, although, it was reported that most deaths are poly 
drug deaths, I will tell you for sure in Florida, no kidding, 
that for half of the prescription drug deaths, the medical 
examiner identified a lethal presence of the prescription drug, 
the chemical compound in that. So, although there may be an 
attempt to lose that in the wash, forget it. It is the 
prescription drug in one half of those 3,200 plus deaths, that 
killed them. There may have been other drugs present, but it 
was the prescription drug that killed them.
    Mr. Souder. Could I get a verification on that?
    Mr. McDonough. Yes.
    Mr. Souder. Would the prescription drug that killed them, 
if they had used that alone, or was the prescription drug on 
top of what they had in their system.
    Mr. McDonough. Well, the doctor that does the autopsy says 
it, present in a lethal amount. Meaning that if oxycodone was 
present in the bloodstream, it was there in sufficient quantity 
to kill them.
    Mr. Souder. Alone?
    Mr. McDonough. Alone. The other drugs I guess they added 
that for the high. I might add it is very difficult to 
ascertain which was the prescribed drug that killed them. 
Because the autopsy does not go into the degree of 
investigation that a law enforcement person might. But it does 
appear to me that a predominant killer in the oxycodone deaths, 
is OxyContin. So, you are right to stress that. There was a 
series of articles published in the paper here in Orlando, that 
was able to trace a number of deaths, several hundred. And it 
gave a figure based on that review, an in-depth review, some 83 
percent of the deaths they reviewed with oxycodone in the blood 
system, was traced to OxyContin. Therefore the author of that 
concluded it was OxyContin that killed them.
    I stress this because it is so easy to talk about the 
caution we must exercise, of course we must exercise caution. 
But the fact of the matter is we are seeing 10 dead a day. So, 
if you are too cautious in preserving--that is one State, 
preserving that 10 dead a day, what you do allow to do--and not 
you, sir, of course--but the collective we, we allow those 10 
to keep dying. Unacceptable, we have to be more aggressive than 
that, I do think that we can preserve what I call the three 
P's. No. 1, pain treatment adequately done. No. 2, the privacy 
of the patient, and No. 3, the sanctity of the patient and the 
doctor and the relationship that ensues between those two.
    After 3 years of working this in Florida, I have very 
little patience for that raised as a new concern. That is why 
we had every player come to the table and every player lay out 
their association's, their group's concerns, I think we have 
addressed them all. What we have not yet adequately addressed 
is 10 dead a day. That is where we have to get and we have to 
get there in a hurry.
    Thank you.
    Mr. Souder. Mr. Mica.
    Mr. Mica. I will just continue, Director McDonough. I was 
quite stunned by the first panel, it seems there is great 
disconnect, at the Federal level, at least from enforcement. We 
had one of the chief DEA officials here who did not know about 
the extent of the problem. And then I guess the newspaper or 
media has revealed some of what is going on and it does not 
appear it is a priority to pursue that. You are our chief 
officer dealing with the problem of substance abuse in the 
State of Florida, what specifically would you recommend to fill 
the gaps, now the State has their agenda and I think we will 
have some testimony from a State Senator that we are going to 
submit to the record, as far as what the State intends to do. 
What specifically can we do to deal with again, the medical 
profession, whether it is a doctor, a pharmacist, or someone 
who is prescribing these legal narcotics in quantities that are 
killing people--what can we do from the Federal level, where do 
you see the gap? How do you see us filling that gap?
    Mr. McDonough. I would say about three major things you 
could do in short order, sir. When I worked in ONDCP I was glad 
to take counsel and guidance from you. ONDCP has made this a 
priority, I think it could be stronger. It ranks up there, but 
from my vantage point it is the most deadly drug problem we are 
seeing in the country right now.
    Mr. Mica. I do not know, Jim, if you were here when I 
talked about the disconnect, you know, you were around when we 
had the National Drug Education Program. It seems to me there 
is a disconnect there. As Dr. Meyer testified that part of this 
is education, and it is, but it does not appear that the 
Federal level we are able to shift gears to get information 
out. Do you see that problem and how do we address that?
    Mr. McDonough. I do see the problem. I think you have the 
power to do that in very effective ways. First of all, is to 
have hearings such as this and second, to give direct guidance. 
I do not necessarily think it takes another law to do that, 
but, of course, when you stress it, when the Congress of the 
United States makes it a priority concern for whatever agencies 
respond to you at that level it becomes a concern as well.
    Mr. Mica. But there is no--again, I see something missing, 
I loved your reports and all when you were with ONDCP, but by 
the time we get them the information is old and by the time we 
hold hearings on it, we are looking at--and the deaths figures 
I have are just dramatic off the charts, in the last couple of 
years, on this problem. So, we have not gotten the message in 
Washington, our Federal agencies are not responding whether it 
is law enforcement or others, and we do not have a program in 
place. So, there is something wrong there and I think we need 
to get with John Walters and others to see how we could do 
that.
    The second motive in question was dealing with the bad 
apples who are--and these things are not coming on the market 
just accidently or through the Internet. We have cases of 
physicians or pharmacists prescribing or issuing incredible 
amounts. What do we do with the bad apple, from the Federal 
level?
    Mr. McDonough. Well, I think you need to go after any 
crook, and not just at the Federal level. Certainly that needs 
to be done, but along with State and local jurisdictions as 
well.
    I would suggest, sir, if you work with the American Medical 
Association on this, they would be in the forefront of wanting 
to crack down on those among their ranks that would violate the 
laws.
    Mr. Mica. Well again, I think we heard sort of the 
evolution of narcotics substances and the treatment of pain, 
and the lack of the law to keep up with the enforcement 
problem. That is part of it and that is going to require some 
adjustments to Federal statues and laws, which I think--I do 
not know if we will get the cooperation of some of the medical 
professionals, what do you think?
    Dr. Norwood. John, I think----
    Mr. Mica. They are not under obligation.
    Dr. Norwood. I think the people who should be and I believe 
are most concerned are those that prescribe medications. We are 
talking about 12 doctors from Florida, well that helps ruin the 
reputations of thousands of doctors in Florida, and they want 
and the pharmacists too--we want these people caught, dealt 
with.
    Mr. Mica. Take their license.
    Dr. Norwood. Well, no that is not enough. Taking a 
license----
    Mr. Mica. Someone said in jail.
    Dr. Norwood. Well, what I said is they could practice in 
jail. Just simply taking their license makes the problem worst, 
it drives them underground.
    Mr. Mica. Let me just conclude with a question, and I 
talked to a couple of pharmacists about the problem, and some 
pharmacists do respond, others are concerned about liability or 
they have other concerns. They see prescription shopping, they 
see over-prescribing of medication, what can we do from the 
Federal level, or is this a State issue, to protect the 
physician--or the pharmacist, but also, allow the pharmacist 
who sees this activity to be protected?
    Ms. Tolle. One of the things that was mentioned by one of 
you earlier was this--and I think it was Chairman Souder--the 
systems that are in place for payment of pharmacists through 
third party companies like where we submit an online claim and 
we get some information back, that the claim has been 
adjudicated and we are going to be paid for that. And I know 
that is part of your outrage, is that insurance companies and 
Medicaid are paying for this illicit use. One of the nice 
things about those programs too is that they send us alert 
messages back, and that really helps pharmacists. Now I do not 
know what the Federal Government can do, per se, but what you 
need to be aware of is that there are systems in place already 
where we are transmitting a prescription claim and getting it 
adjudicated, and it seems to me that a system like we are 
talking about with this controlled substances monitoring 
would--you could do something very similar you could transmit 
and get some sort of message back about what this patient had 
received or something like that.
    I think that the bill that Representative Norwood has 
proposed to provide funding----
    Dr. Norwood. It is a draft.
    Ms. Tolle. OK, I am sorry.
    Dr. Norwood. Work in progress.
    Ms. Tolle. I have seen the language, or I have seen the 
draft. I think what is being considered right now is a great 
idea. I think you are moving in the right direction with that. 
By helping to fund the States that are willing to do that, and 
I do not know if it could be a Federal program or if it needs 
to be State by State. But I think encouraging States to do some 
sort of monitoring program to allow, to help their 
professionals to get that message, to know what is out there.
    And of course I agree with all the efforts to do 
educations, I like what was said about the genome project and 
what we are going to have in the future to identify perhaps 
before it ever happens, the people who are going to be subject 
to that, I think education is definitely a big part of it. In 
the whole mental health and the issue of depression and 
identifying patients who might be prone to it so we can stop it 
before it happens.
    Mr. Mica. Do pharmacists need some protection against 
reporting folks, because I have heard that is also a problem, 
that they are reluctant sometimes.
    Ms. Tolle. I guess there is always a possibility of a 
pharmacist being concerned about liability, but if you are 
reporting somebody who is obviously violating the law, I do not 
know why there would be a liability concern.
    Mr. Mica. OK.
    Ms. Tolle. I mean there may be pharmacists out there who 
have that concern, but it becomes pretty apparent after awhile, 
when a physician is prescribing outside the normal limit.
    Dr. Norwood. Mr. Chairman, would you yield on that subject?
    Mr. Mica. Yes, go ahead.
    Dr. Norwood. Let me just point out and I have been working 
on this bill for awhile and our biggest single concern is 
liability in HIPAA. If we cannot get the job done, it is going 
to be for that reason.
    Mr. Mica. OK, and then just--I am through Mr. Chairman, but 
while I have Ed McDonough, here, one of the most startling 
things I have learned today is that we have a Federal program, 
Medicaid in this case, we learned is being abused--actually a 
major conduit to putting lethal prescription drugs on the 
market and some years ago in fact our subcommittee or the 
predecessor of this subcommittee did a lot of work with the 
Florida Legislature in getting--Florida officials in getting a 
Medicaid task force, fraud task force. I do not know if that is 
still operating we had $1 billion between Medicaid and 
Medicare, in over-billing and fraudulent charges. Certainly if 
we have people dying as a result of distribution systems being 
set up through a Federal program for obtaining these 
prescription drugs, it should be the focus of attention.
    Is it still in place? And if you do not have that 
information now I would certainly appreciate you reviewing it.
    Mr. McDonough. No, sir, we have it, and we can do a better 
job with it, and we resolve to do a better job with it. We have 
a Medicaid fraud unit. The way the system works the Agency for 
Health Care Administration in Florida takes a look at the data. 
If you recognize something should be passed off for 
investigation, it needs to be done in a timely fashion.
    Mr. Mica. I am aware of the procedure, but are they now--
this is outside of some of their original purview and purpose 
but certainly, you know, it is against any policy that we would 
promote at the Federal level to have this going on. Are they 
pursuing----
    Mr. McDonough. They are. If Senator Saunders had been able 
to come today, he would have laid out a number of hearings he 
has held. They were very well done hearings, in which he has 
given great incentive for the system to coordinate better, and 
he will now back that with a series of laws that will further 
strengthen it. Part of his appeal to you was to ask for the 
Federal laws in the Medicaid systems that would make the 
penalties appreciable should someone try to do the very thing 
that we are talking about.
    Mr. Mica. Well, thank you. And we will take his testimony 
and recommendations back and your suggestions. Appreciate the 
panelists and I yield back.
    Mr. Souder. Thank you. Dr. Norwood.
    Dr. Norwood. Thank you, Mr. Chairman. Mr. McDonough back to 
the 12 physicians again and I do not want to belabor this but I 
am curious. Let us say they were indicted and found guilty or 
even one of them was. In Florida law what would be the penalty?
    Mr. McDonough. If there were deaths involved most likely we 
are looking at manslaughter. In fact, we had a historic case of 
manslaughter, one doctor in Pensacola, four counts. I actually 
think there were 11 dead associated with his practice. But if 
there is a deceased, it is manslaughter, and then the requisite 
penalty that comes with that, a long time in prison. Now, it is 
difficult to get a manslaughter case, as you know, and even 
harder to get a murder case. But we are looking at that as 
well.
    Dr. Norwood. Well, simply the overuse or allowing the 
overuse of Schedule IIs and IIIs where there is not a death 
incurred but, however, we see clearly from the record this 
particular person is way over-prescribing this drug, what can 
you do to stop it before a death occurs?
    Mr. McDonough. You get into the gradations of when a crime 
is committed. Was it lack of education, was it an 
administrative problem? If it is at the lower end of the 
spectrum, then the Board of Pharmacy, if it is a pharmacist can 
move, or the Board of Medicine, if it is a doctor can move. 
They can suspend that license or revoke that license. Since it 
takes a while to revoke a license, in extreme case of 
administrative error, most likely the Secretary of Department 
Health would revoke a license. If you cross the line into 
criminal activity, then you can prosecute for the violation of 
the law. You cannot be a drug dealer under any law, a drug 
pusher.
    Dr. Norwood. So, it is criminal activity to start with.
    Mr. McDonough. At that point that I just described yes, 
when you were wantonly pushing the drugs knowing you do not 
have a legitimate patient, you have done only a cursory or no 
physical examination, when it is done on such a scale that the 
rational man would say this guy is pushing pills, you have a 
case.
    Dr. Norwood. How many deaths in Florida, from OxyContin 
occurred from people taking OxyContin in a prescribed manner?
    Mr. McDonough. That is a very tough question, I do not have 
an exact figure.
    Dr. Norwood. You need to be real sure, do not guess on 
that. Now that is important. There are many drugs--penicillin 
will kill you. And it can kill you taken in a prescribed manner 
with antiphylactic shock. There are many, many drugs out there 
that were used, thank God every day, but they can kill you in 
normal usage and there are that many more that can kill you if 
you are over-taking the particular drugs. I do not know how 
many--Doc, do you have any idea how many medications are 
available out there to health givers that actually cause the 
deaths of patients if taken in an overdose?
    Dr. Berckes. Virtually everything that is a prescribed drug 
and many things that are not prescribed drugs have the 
potential to cause death.
    Dr. Norwood. I guess water can too, you know, taken in an 
overdose.
    Dr. Berckes. Right.
    Dr. Norwood. Let me ask you--this is just a simple question 
I am curious about, I know you are a particular expert in pain 
management, I also know though physicians do not get through 
medical school and all the subsequent training without having a 
fairly good idea about some pharmacology. Maybe some in New 
York, but most of them I know about have a pretty good 
education in that. Do you really think there is any physician 
in Florida that would not understand that there are dangers in 
some of these drugs in terms of being addictive. Do you think 
they are actually out there practicing medicine that do not 
know that?
    Dr. Berckes. I think that there are a lot of--there are 
many physicians that do not understand the potential, I am not 
making excuses for them.
    Dr. Norwood. I do not see how you get through med-school 
and not understand the potential at least for addiction they 
may not understand it at the level you know, but they know when 
they write that script for, you know, Ms. Jones, we have to be 
careful here.
    Dr. Berckes. There is a couple of things. First of all, 
there are a lot of studies that have shown that when narcotics 
are used to control pain, you do not get the addiction. There 
is a small percentage of people predisposed. But I think 
speaking of the larger issue and I try to avoid using brand 
names, but OxyContin is one we can not avoid. I believe because 
I was in this boat when this drug was rolled out, despite the 
education that was provided by Purdue, those of us that are 
using narcotics are very familiar with a sister drug, called MS 
Contin. MS Contin is made by the same company, and it is 
morphine sulfate. Classically one of the advantages of MS 
Contin versus immediate released morphine is that the abuse 
potential was virtually eliminated, because of the sustained 
release preparation that this company I assume patented. There 
was not the ability for it to be abused, or it markedly 
decreased.
    A lot of us believed incorrectly that using oxycodone in 
the form of OxyContin would afford us some of that same 
protection. The sustained release chemical in the way that 
oxycodone is released in the OxyContin it turns out is nothing 
like the MS Contin, so I believe there was a lot of confusion 
where there was intent to prevent the abuse, potential abusing 
oxycodone preparations by using OxyContin. We inadvertently did 
just the opposite.
    I do not believe, I am sure there is a lot of scientific 
data that they had to go through with the FDA to get there. I 
do not believe there was any deliberate misinformation put out 
there, but this was an unintended thing, just to clarify.
    But indeed there are doctors that think they are doing the 
right thing, and one of the other things especially that I have 
noted with this drug, when for whatever reasons you calculate 
the drug and you maybe are giving a little bit too much, and 
patients forget when they take medications. I forget, when I am 
prescribed by my doctor, if I do not write it down. All it 
takes is taking an extra OxyContin if you are already getting 
the higher level and you take another one you are dead in a few 
hours.
    Dr. Norwood. I have a few more questions I have to get 
answers to, and a quick answer on this. Severe pain, moderate 
pain, the FDA refers to that a lot. I have never understood how 
you actually define severe pain and moderate pain. One patient 
has a problem that can be solved by an aspirin and the other 
patient has the same thing and they need a barbiturate, how do 
explain that, can you use severe and moderate in a sensible 
way? Because what is severe for one patient may be absolutely 
moderate for another. Do we understand that yet?
    Dr. Berckes. These are subjective monitors, OK. There is no 
easy way.
    Dr. Norwood. But that is not how FDA writes it.
    Dr. Berckes. No, and I think there is too much wiggle room 
there and I do not know how to--we use classically and it is 
being incorporated as the fifth vital sign, the visual analog 
scale of pain. Where 10 is the worst pain imaginable and 0 is 
no pain. But we know that people report differently. The same 
pain is reported differently because of their different 
thresholds, because of the way they are made up. There is no 
way to use just one pain measurement OK, to say for sure what 
this is. So we use historical precedent. We know that a crush 
injury of an extremity is certainly different than the surgical 
wound caused to fix a hernia, and these are all different 
things. This is, sir, the art of medicine, trying to hook it 
together with science, and there is no way--especially in this 
whole area of pain medicine, there is no meter that I can have 
a patient put their hand on and I can tell where their pain is. 
If there was I think we would have a better way to handle it.
    So, it is the subjective complaint and following patients 
on a very close basis that you are going to do the best job.
    Dr. Norwood. Well you answered it how I wanted you to 
answer it, and I particularly wanted----
    Mr. Souder. Would the gentleman yield?
    Dr. Norwood. Of course.
    Mr. Souder. I am fascinated with this subjective question 
because to me, the greater the addiction potential and the 
greater that we see abuse of that I would think that you would 
move toward a tighter application at the medical profession. 
For example, I just had hernia surgery, I was being asked all 
the way through, at least as well as I remember and afterwards 
as far as my pain medication, what level of pain can you 
tolerate. The answer is you want to tolerate no pain.
    Dr. Norwood. Correct.
    Mr. Souder. And so, if you are given choices you will keep 
taking it. The question is that if something is highly 
addictive and been abused, should the standard ratchet up, 
other than the individual identifying, which is kind of 
underneath. If this is an art, should the art be more 
constrained the more high risk you are----
    Dr. Norwood. Part of the problem, Mr. Chairman, is, at 
least in the 1970's I think health care givers were overly 
constrained and a lot of people suffered during those years, 
because physicians and dentists alike were very hesitant to 
write some of these prescriptions for the very reasons that we 
are here about. On the other hand, there is a moral obligation 
as a health care giver to try to deal with the pain the best 
you can, and it is subjective. I just want to be careful that 
when we start legislation in Washington we remember that. The 
FDA in my view tries to make it black and white and it really 
is not that.
    Ms. Tolle.
    Ms. Tolle. Yes, sir.
    Dr. Norwood. Ms. Tolle, do you have a computer in your 
pharmacy?
    Ms. Tolle. Yes, sir.
    Dr. Norwood. Do most pharamcists today in Florida, have 
computers?
    Ms. Tolle. Yes, sir. My understanding is there is may be a 
few in south Florida, that are primarily Latino pharmacies, 
that may not be computer based, but I would say probably 95-
plus percent at least maybe greater.
    Dr. Norwood. How would you operate today without a 
computer----
    Ms. Tolle. I have no idea.
    Dr. Norwood [continuing]. Due to the large different 
variety number of payers.
    Ms. Tolle. Right.
    Dr. Norwood. We know that too. We think most of you have it 
and part of our thinking in this legislation we have here is 
that as you swipe a card through your computer and send it to 
Blue Cross and Blue Shield there is not any reason on a Class 
II or III that same information cannot go to Mr. McDonough.
    Ms. Tolle. That is correct.
    Dr. Norwood. There has to be--in our view, there has to be 
some single source in the State of Florida that is monitoring 
this if we are ever going to get a handle on it. And the 
question becomes, Mr. Chairman, who is entitled to know about 
that information? That scares us to death. I know it would be 
helpful to you, Doctor, to be able to monitor that particular 
data base and know and find out if your next patient got a 
Class II 2 days earlier. It would be helpful for you to know. 
On the other hand, if you did not then where is your liability. 
And who else gets to know in terms of HIPAA?
    That is the problem that we are running into in trying to 
build this bill. If we can put privacy in it, and if we can 
limit the liability so that if for some reason the data you 
swipe through did not go through unintentionally then the next 
thing you know you are in court. I think we can solve this 
problem except that I do not know how to solve the Internet, 
and I am open to any suggestions. I think we can solve this 
problem if we can solve privacy and liability.
    Ms. Tolle. Can I comment on Internet?
    Dr. Norwood. If you have the answer, baby, I am ready.
    Ms. Tolle. I do not necessarily have the answers but I have 
some friends from Florida Department of Law Enforcement here in 
the audience, and one of which I was speaking with last week 
when we had a drug symposium in Tallahassee, and again today. 
And he suggests to do reverse tracking on these sites. Where 
you can track the source where this medication is coming from. 
So you would need somebody who was well versed in tracking, 
much like a child pornography type of investigator, where you 
understand the computer science and you could follow those 
headers, and work backward. And maybe that would help solve 
some of the problem with these sites, I know that many of--I 
know it is multi-level, I understand that it is a really big 
process.
    But that is one point that I have not heard brought up 
today, and I felt like it was definitely worthy of being 
mentioned.
    Dr. Norwood. The problem is my 13 year old daughter goes on 
the Internet and types in a particular drug and sure enough, if 
she will just lie about her age, it is going to be filled and 
the way they do that is they have a rogue physician there that 
works at the site who signs every prescription.
    We are trying to figure out how we can make them make sure 
that you sign the prescription without intruding too much, and 
causing you too much liability.
    Ms. Tolle. We do have proposed language in Florida this 
year for Internet prescribing--for the Internet in particular 
and that language requires a prescript--an actual physical 
assessment of the patient. A pharmacy is not allowed to fill a 
prescription based on an Internet questionnaire if they are 
aware that it is an Internet only questionnaire only.
    Dr. Norwood. I know that you do have that, but that is 
going to bring down the rath of God on us. You know, what we 
are trying to do is work with all parties here, and there is 
going to be a lot of parties that are not real happy that they 
have to answer to you about a physical before they prescribe. 
That may end up being the way it is dealt with, but it is 
certainly something that is going to cause a lot of grief 
trying to get 218 votes, I can tell you that.
    Mr. Chairman, I thank you, and I yield back.
    Mr. Souder. That is valid point, it is amazing what you 
can--if you would wait just a second, I have a question for you 
as well. I wanted to note that this is not that dissimilar in 
some ways from how we work with other narcotics. In other 
words, one way you look at where the production is, who is 
making the stuff that goes into the stuff, whether it is a 
controlled area or uncontrolled area. That can be problematic 
if it is not uncontrolled, but watching for leakage and 
slippage from the controlled area where it is being made, I 
understand Tanzania and other places like that, you look and 
see where the quantity, if it is not going to you, is there 
slippage there and are there other places that are being 
supplied.
    And second would be the manufacturing of it, who is getting 
it and track those locations, and then, if indeed it winds up 
that because of restrictions here it goes outside like to India 
or other places, then the obvious delivery system becomes 
critical, because we are not going to be able to get it on the 
Internet, for the most part. We are going to have to get it in 
the delivery system, or the manufacturing or the growing.
    The question I have for you is under current HIPAA and 
where does this go since we heard that many of these people are 
probably drug users, is that a criteria and is there a 
mandatory check to see if somebody has been picked up for a 
drug conviction before? And make that group if there are more 
prone to being addictive or seeking it for the wrong reason, 
why would that not be an automatic background check required in 
the prescription?
    Dr. Norwood. Well, Mr. Chairman, I do not recall and I do 
not believe that is in HIPAA, but however----
    Mr. Souder. Would it be prohibited?
    Dr. Norwood. It is prohibited, among the other law already. 
Part of this is we have a lot of laws on the books, we do not 
enforce some of them. And the DEA--I am not as rough on them as 
John is, they will never have enough people to enforce this. 
There is no way on Earth that they could have enough people in 
the State of Florida to actually do what we need to do.
    Mr. Souder. Dr. Berckes, when you as an anesthesiologist, 
do a background check, the person is asked whether or not they 
are using substances, the question is is there a background 
check to see if they have ever been arrested?
    Dr. Berckes. No. In my practice and that is not the general 
practice, however, in cooperation with our Sheriff's Department 
and the detectives, we have had a real close working 
relationship. What I have is that every patient that walks into 
the office every time, not just the first time, they sign an 
affidavit in addition to me gathering the information that may 
have changed since the last time they were in the office, 
whether that was the day before or a month before. They sign an 
affidavit that they have not received any other controlled 
substances from any other physicians or if they have, who that 
doctor is and what it is. That has worked really well because 
then when they sign that and we do all the legal stuff correct, 
then that is data that I guess the district attorney has been 
able to use for the prosecutor.
    Dr. Norwood. Yeah they can, but you know--remember, this 
person who is in there to beat you out of this Percocet is 
going to burn your building down if you do not give it to him 
one way or the other. They are going to sign anything you say.
    Dr. Berckes. They do. What I am saying is that has helped 
on the law enforcement end. But, there is no way that I can 
physically do a background check with any tool that is 
available now to know the veracity of the information that 
patient is given me. I mean there is a lot of things as far as 
the sniff test we can tell----
    Mr. Souder. There are two types of things, that is why I 
thought we were maybe getting into HIPAA questions, because 
this is another type of way to address this, because some of 
these people may not be trying to beat the system, they may 
just have in the past used narcotics that shows in the risk 
assessment, that in fact they have a tendency to become more 
addicted, and not be able to get off. And they may not realize 
that even though--and they may not want to release that to you.
    The question is and this is one of our pop up questions. 
Because we are having to get this for border control now, we 
are looking at when you get on an airplane, are there certain 
things that are basically in the system. It is a huge civil 
rights debate, but the question here is that you are also, 
protecting--we are not just looking for legal protection for 
the doctors, which we need to look for too. Because what people 
do not understand when you get sued it is not you who 
necessarily pays, it is everybody who comes to your practice 
who has to pay higher rates because of the malpractice 
insurance.
    So, we have to do a lot of these things to protect you 
which is paperwork, and maybe--although most prosecutors 
probably do not waste their time on somebody who falsified a 
document, at least it is another level. The question is, that 
just seems like basic information, if risk assessment is that 
critical for the addiction and the danger, that you would have 
a pop up that would say that we can check and see who is an 
abuser. Now that is not necessarily an abuser of OxyContin. I 
was thinking more of the statistics that 2.8 times likely 
heroin, 1.7 cocaine, three times before have used, if we are 
picking it up in the autopsies, and if we are picking it up in 
the research, it seems like it ought to be something that ought 
to be much more restrictive at the beginning.
    Because OxyContin, the difference--what I would put here 
is, yes all these other drugs may be at risk and it may shift. 
But this is not a maybe, what we heard from the DEA is they 
have never had anything that caused this much death.
    Even though it also may be relieving more people of pain, 
if we can figure out how to manage those two questions and if 
there is a level of use; once it reaches an epidemic proportion 
and there is X number of deaths in society, all of a sudden 
civil liberties waiver on if you have been a narcotic. I was 
just wondering what we are running into, because I am not a 
doctor, and I----
    Dr. Norwood. Well, I do not think HIPAA envisioned that 
there would be a source of information on people's medical 
records that stores up the usage of narcotics. Having said 
that, I have no doubt in my mind that if we did do that, that 
somebody is going to read into HIPAA why it is against that.
    Dr. Berckes. I just wanted to say I do this everyday, and I 
have been fooled. There is no way that anybody that does this 
can say you cannot be fooled that you cannot be scammed. But I 
want to dispel what I believe is the myth that writing one 
prescription of OxyContin or any other controlled substance, 
even if somebody who is genetically predisposed to drug abuse 
or addiction, that you are going to turn them into an addict. 
That is where the close monitoring of the drug and using the 
smallest hammer that you need and then ratcheting up as 
required. That is the only way that you are going to do it.
    So, you can be fooled, but it is those tools and there is 
no substitute for that face-to-face looking at the patients 
seeing what they are doing and having them account for every 
pill. Can they scam you? Sure, but it cuts down on it 
drastically if they know they are being accounted for. And I 
can tell--it is hard to measure, but I can tell the people that 
come in that is all that they want. OK, and then they usually 
leave, yeah and the people working in my office, they are 
scared with some of these folks. And I am looking for their 
protection, but that does not keep us from the mission of what 
we are trying to do. And luckily, at least in my situation 
there is a close tie in with law enforcement.
    What I have seen too much of I believe in the press is that 
you can have good intentions, write one prescription and you 
have turned somebody into a street drug addict. Sir, that does 
not occur. It is a continual misuse of medications. OK, the 
unbridled prescription without keeping track of what is going 
on, that is what leads to the problem.
    Mr. Souder. Because many pain killers are prescribed for 
multiple use over a period of time, if you have a 
predisposition, you are more at risk than if you do not have a 
predisposition.
    Dr. Berckes. Yes.
    Mr. Souder. What I was kind of addressing is that it seems 
to me that you would get stopped for driving 62 miles an hour 
in a 55 zone. They can figure out what happens to you, why can 
we not when we are prescribing a potentially high risk 
addictive drug that can cost you your life, why can we not get 
this information that State cop has on the highway, about your 
past drug and alcohol addiction. It just seems like a 
disconnect.
    Dr. Berckes. Right. And there is never too much 
information, and asking those questions is something that the 
prudent practioner does. I mean we are required to, to practice 
good medicine.
    Mr. Souder. You are asking the questions, but you do not 
have a way to verify it.
    Dr. Berckes. But there is no way to check on the veracity 
of the answer, I mean, the whole doctor-patient relationship is 
predicated on trust and valid information. And how we can--
there is no 100 percent way, there are subtle things you look 
at with a patient--the way they come in, what they are saying, 
who they are with, how they got to your office, these are all 
the subtle things that you have to look at, but we still are 
going to be fooled.
    But I am just concerned we already have a DEA, every doctor 
that prescribes narcotics in this country has a DEA number. So, 
it seems like we already have that data base, at least on the 
prescriber end.
    So, I am interested in how are we going to--there is one 
way, there are two ways of monitoring it. It seems like we have 
the data base with the DEA, with the DEA number, Dr. Norwood. 
The DEA number you have on all the doctors in this country, we 
are all required to have DEA number.
    So, that data base is there. But what is the information 
that we should be requiring and linking up in a national system 
for the patient. And that is where the HIPAA thing comes in. 
Because I tell you what, when I go online, OK, with my Bank of 
America account, here in Florida they know exactly what is 
going on in California, immediately. OK, and because it is that 
cross, I think the technology is there but I am concerned about 
folks that come into Florida. I mean it does not take long to 
get from the State of Washington to Florida. OK, and you think 
you are doing the right thing with the drugs and I would like 
to know, because if they are trying to scam me, they are not 
going to tell me well, what at 4 p.m., the pain doctor in 
Seattle gave them. OK, and then they are showing up in my 
office. I would love to have that information.
    It just seems to be the privacy thing, but what are we 
going to use driver license number, Social Security numbers, 
you know we already have the prescribers with DEA. And what is 
the other thing, because whatever that other number is then we 
have fraud that is potential on that end. And that is where my 
biggest question is, and I think if we could address that, it 
is not a very sophisticated computer system that would need to 
figure it out. But it is who is going to look at it. I am 
asking the questions, I do not know, but it seems like we have 
it right here. And with respect to when we have a crisis, what 
do you do with a practitioner.
    Well, I am chief of staff in a hospital, and when I have 
evidence that a physician is really out of line I am obligated 
and I have the legal ability to summarily suspend practice of 
that physician in that institution, until I get together all of 
the entities I need to see what is really going on. And we have 
a hearing process, and all the rest of it. And it seems to me 
that the Board of Medicine has a similar thing, but there seems 
to be a disconnect between the what is happening out in the 
street and the Board of Medicine. And then issuing, and how 
they can issue that appeal, that is not a Federal thing, but it 
seems like there could be Federal guidelines.
    Mr. Souder. I thank you.
    Dr. Henningfield. May I just add one part of the balloon 
that has not been directly touched on? And that is that one of 
the highest risk groups is young adults. And if we take a 
really long range view of this problem, we have to be looking 
at community efforts, we have to be looking at educational 
efforts. We know from our surveys that kids who have an 
increased perception of harm, that is a technical term, are 
less likely to abuse drugs. No kid should go to a party and 
have something offered and then be reassured that this is not a 
street drug, it is a prescription drug. Or what if they are 
reassured that it is not OxyContin, do not worry, it is 
something else? Kids should be getting a clear message from 
every source that using any prescription drug without a 
prescription is potentially lethal, and that prescription pain 
killers can be as lethal and as addictive as any other drugs.
    I have looked at the textbooks, this message it is not 
there, our system has not caught up. I do not think it takes a 
law to stimulate this. But working with Federal agencies like 
NIDA, and substance abuse prevention office of SAMHSA, you can 
encourage them to work more aggressively to get out the 
messages. And package them if you will, because the message 
here is a little tricker than it is for cocaine. The message 
for cocaine is easy, ``do not use any, any time from any 
source.'' With a prescription drug it is a more complicated 
message. And there is work there that our Federal agencies that 
have good people could do with encouragement and probably some 
funding from you.
    Mr. Souder. I thank you for your testimony, we will 
probably have some additional written questions, if you want to 
submit any additional testimony. This stuff is very difficult, 
I know when this committee was actually divided into human 
service separate from the drug policy. Chris Shays was head of 
Subcommittee on Human Services and I was his vice chair, and we 
went through a number of things on the second use of drugs, 
which is the un-talked about huge thing in America, which is 
where the real kind of profit of the pharmaceutical companies 
often come from word of mouth, and hey, this works for this 
over here. And boosts the sales, and it is something that in 
our society it is very difficult to tackle the messages of what 
is safe and when.
    Furthermore, our research on the interactive properties of 
these different types of both over-the-counter, yet alone 
prescription drugs. And trying to do this is very difficult, 
but when we have an epidemic level like we have had on one, it 
is an opportunity both to educate and help the public 
understand how best to manage it.
    Well, thank you for you time, thank you for coming today.
    Third panel come forward. Now if each of the witnesses will 
stand and raise their right hands.
    [Witnesses sworn.]
    Mr. Souder. Let the record show that each of the witnesses 
responded in the affirmative.
    We thank you for your patience and as we do with all of the 
panels by tradition of the committee, the administration 
witnesses rise on the first panel, and then as the panel 
evolves we get more and more into the individuals and the 
individual practitioners and it has been a very helpful 
structure how we generally do this. I thank you for coming, Mr. 
Pauzar you are first.

  STATEMENTS OF FREDERICK W. PAUZAR, FATHER; DOUGLAS DAVIES, 
   M.D., MEDICAL DIRECTOR, STEWART-MARCHMAN CENTER; PAUL L. 
  DOERING, M.S., DISTINGUISHED SERVICE PROFESSOR OF PHARMACY, 
    UNIVERSITY OF FLORIDA; KAREN O. KAPLAN, M.P.H., SC.D., 
 PRESIDENT AND CEO, LAST ACTS PARTNERSHIP; AND CHAD D. KOLLAS, 
  M.D., MEDICAL DIRECTOR, PALLIATIVE MEDICINE, M.S. ANDERSON 
                     CANCER CENTER ORLANDO

    Mr. Pauzar. Thank you, Chairman Souder, Representative 
Mica, Congressman Norwood, for the opportunity to testify here 
today.
    My name is Fred Pauzar and I am the father of Chris Pauzar, 
a brilliant 22 year old who died from OxyContin 76 days ago, 
just 2 days before Thanksgiving. The tragedy of losing a child 
is not something one should ever be forced to imagine, I will 
simply submit to you that the pain from this loss is so great, 
it overshadows nearly everything else in my life.
    But each life that can be saved through the enactment of 
proper legislation and regulatory standards and procedures will 
be a life whose potential for greatness, whose contributions to 
mankind, may still be achieved. Each premature and needless 
death, such as that of my own son, is a heart-shattering 
occurrence that also deprives society of all the brilliance, 
all of the achievements, all of the greatness that will now 
never come to pass.
    OxyContin was originally prescribed to my son for a minor 
injury to his shoulder. His frequency of dosage increased over 
time until he was taking 200 milligrams or more per day. All 
along, he was reassured that the long-term use of this drug was 
not harming him, both by his physician and by Purdue Pharma 
literature that suggested the appropriateness of prescribing 
OxyContin for pain that would be ``expected to persist for an 
extended period of time.''
    When my son ultimately realized that he was addicted to 
this drug, experiencing flu-like symptoms and physical and 
emotional distress when he stopped using it, he needed and he 
sought regular therapy and medical support to detoxify, and to 
learn to live without Oxy in his life. Unfortunately, after 
breaking the pattern of daily use he wrongly decided to take it 
one more time, actually saying one more time would not kill me, 
the very evening that he died.
    Since my son's death, I have been stunned by facts related 
to the marketing, prescribing, use and abuse of the drug that 
killed him. And I have been astounded that a clear and 
insidious correlation exists between the market penetration 
this drug has achieved and the toll of death it has left 
behind.
    OxyContin came into existence in 1995, when according to 
U.S. District Judge Sidney Stein, Purdue Pharma deceived the 
U.S. Government by engaging in ``inequitable conduct before the 
Patent and Trademark Office'' in order to patent OxyContin. Its 
sales literally skyrocketed since, thanks in part to very 
aggressive marketing and the promulgation of performance claims 
that have not held up to scrutiny.
    In 1995 and 1996 Oxy was sold as a chronic pain medication 
for use with cancer patients--very appropriate. Then in 1997, 
Purdue Pharma began to push this drug into a new market, such 
as back pain and injury. At the same time the company was 
reaching down into the broader market of moderate pain 
treatment, it added a more potent dosage, beginning the 
manufacture of 80 milligram tablets to complement the smaller 
10, 20, and 40 milligram pills they were already producing, and 
so, by 1998, fully two-thirds of all Oxy prescriptions issued 
were for non-cancer pain.
    Cleverly, Purdue Pharma paid for hundreds of physicians to 
travel on junkets where they were educated about the benefits 
of OxyContin, a Schedule II drug without a ceiling on allowable 
dosage. Meaning it is very difficult to decide when you are 
over-prescribing. Those physicians were, in the manner of a 
pyramid, told they would be paid speaker's fees for talking to 
other doctors about the benefits of OxyContin.
    By 1999, Purdue Pharma's objectives included a reach toward 
one-half billion dollars in sales of their star drug, with 
their marking efforts targeting more consumer groups including 
seniors with direct to consumer advertising. It has been said 
that there was no DTC advertising and that is incorrect, 
because you could have walked into a number of different 
doctors' offices and seen placards in full color showing a 
grandfather with a grandson fishing in a stream, talking about 
how long term relief is at hand.
    Again, while the marketing efforts sought to aggressively 
broaden market penetration, the manufacturing side of the 
company delivered an even more potent tablet once again, a 160 
milligram pill.
    By 2001, Purdue Pharma had comfortably rocketed past the $1 
billion mark in sales from this single drug, with the company 
noting in passing that the challenges presented by mounting 
evidence of OxyContin abuse in Florida, Maine, Ohio and other 
States, ``will continue to be a threat to the continued success 
of OxyContin tablets.''
    In 2002, OxyContin sales hit the $1.2 billion level, 
representing more than 80 percent of Purdue Pharma's total 
revenue, due in part to the advantage handed Purdue Pharma by 
our own FDA. As Purdue Pharma's marketing group noted in the 
face of mounting evidence that deaths in Florida and other 
States from OXyContin were exceeding deaths from heroin, 
despite what we were told earlier by the DEA representative. I 
am quoting now, ``It is unlikely that an opioid approved by the 
FDA in the future will have as broad of an indication as 
OxyCOntin now enjoys.'' The company knew that only too well.
    And in this regard Purdue Pharma is certainly correct. With 
the unwitting actions of many fine physicians who relied on the 
marketing promises made by an aggressive Purdue Pharma sales 
force, with the calculated and illicit actions of a small 
percentage of doctors who abused the system, and with a system 
that statewide and federally has been slow to communicate and 
to recognize the danger of this drug and to respond in an 
appropriate fashion, the daily death toll continues to mount.
    In Florida alone, we can argue whether it is one person a 
day or 10 a day that die from this drug, but we know that the 
loss is truly incalculable but nonetheless devastating and 
real.
    May you have the wisdom and the courage to deal effectively 
with this threat to our children and our society overall by 
taking effective steps now to monitor and curb the improper 
marketing and use of Oxy. And may you never know the pain that 
I along with thousands of parents before me and hundreds if not 
thousands more since, now feel.
    Thank you, and I will be happy for your questions.
    Mr. Souder. Well, thank you for sharing with us the pain 
that you feel in your family, and your trying to address the 
problems.
    Dr. Douglas Davies is medical director of the Stewart-
Marchman Center, thank you for being with us.
    [The prepared statement of Mr. Pauzar follows:]
    [GRAPHIC] [TIFF OMITTED] 95555.129
    
    [GRAPHIC] [TIFF OMITTED] 95555.130
    
    Dr. Davies. Good morning. Thank you for opportunity to 
address the panel.
    The perspective I bring is one of a physician and I do have 
some pain management that I do as part of my practice. I worked 
as an anesthesiologist for many years. Currently, I am an 
addictionologist in the University of Florida Department of 
Psychiatry, Division of Addiction Medicine. I also bring to you 
the perspective of being a person in recovery from the disease 
of opiate addiction.
    As we have heard already, substantial quantities of 
prescription drugs are being illegally diverted in Florida, 
which results in a tremendous amount of death, it fuels the 
disease of addiction. Statewide the numbers I have seen 
included a 120 percent increase in treatment center admissions 
over the past 2 years for prescription opiates at our center. 
There is a summary of data available from Dr. Ernest Cantley 
the head of Stewart-Marchman showing more like a 400 percent 
increase in our admissions for treatments for opiates.
    Diversion consumes State resources through associated 
medical expenses trying to take care of these people, through 
Medicaid fraud that we heard abundantly, and through treatment 
expenses if people are fortunate enough to make it to 
treatment. Prescription diversion certainly involves many 
scenarios--prescription fraud, illegal resale of prescriptions, 
doctor shopping, pharmacy shopping, and loose prescribing by 
practitioners characterized by the five Ds. Those are doctors 
that are duped, well-meaning physicians that who are simply 
getting slickered by patients looking for the drugs.
    There are, on the other hand, dishonest practitioners. I 
know in my own community, my patients everyday tell me that so 
and so is a prescription mill, and so and so is a pill doctor. 
Physicians who are dated, who simply do not have adequate 
knowledge of how to--what are appropriate uses for these drugs. 
Physicians who for various reasons are dysfunctional, and 
simply cannot say no to patients, and physicians who are 
disabled by their own substance abuse issues.
    Prescription drugs have overshadowed street drugs in 
several categories. In 2002, benzodiazepines accounted for more 
overdose deaths than cocaine. And in 2002, oxycodone, 
hydrocodone and methadone and benzodiazepines individually were 
involved in more overdose deaths than heroin. The problem is 
getting worse and there are abundant laws to deal with the 
perpetrators of prescription diversion. However, I believe it 
remains needlessly complicated to identify who these people are 
in the State of Florida.
    When I have a patient sitting in front of me and I am being 
asked to perform an assessment to see whether or not they have 
a problem with prescription drugs, I have to spend hours on the 
telephone trying to call numerous pharmacies, assuming the 
patient is using his real name at the pharmacy and that he is 
even going to local pharmacies. Even when a patient reveals 
names of practitioners to me that are known to be pill doctors, 
it remains a daunting task as we heard earlier this morning to 
gather data on these people, and to investigate them.
    Many other States do currently, and we have heard several 
numbers this morning 15 to 18 States at least currently have 
prescription monitoring systems. And in 2002, a GAO report 
described their effectiveness in reducing the diversion, by 
reducing inappropriate prescribing by practitioners and by 
serving a deterrent for doctor shopping, and by reducing the 
resources that have to be expended on investigation.
    The current prescription validation program up for 
consideration in this State, would establish an electronic data 
base containing prescriptions of patients over the age of 16. 
For it to make any sense it certainly need to cover all 
controlled drugs not just drugs in the higher schedules, but 
all controlled substances. It would make this information 
available to physicians, to pharmacists, to medical quality 
assurance personnel, and to law enforcement. And then some very 
simple requirements for reducing prescription fraud. It would 
require simply the quantities be written out, it is much harder 
to alter a prescription where all of the number quantities are 
written out, rather than stated in their numeral form. Require 
picture ID to pick up prescriptions. There is a typo here 
saying I recommend you use of counterfeit prescription forms, 
actually I recommend the use of counterfeit-proof prescription 
forms, and that this whole system would be administered by the 
Department of Health.
    There is already a great deal of funding in place for this 
program. Purdue Pharma is said to be providing the State with 
$2 million for the development of software to get this set up 
and the Department of Justice has also established a line of 
funding for this program. Certainly with the national scope of 
what we are talking about today this does need to be a national 
program. I know in the State of Florida this has been up for 
consideration for several years and shot down for several 
years. I certainly hope this is the year that is going to pass.
    Thank you very much.
    Mr. Souder. Thank you. For the record, for my information, 
but also, for those who reads the record is Stewart-Marchman 
Center a specialist center or general hospital treatment.
    Dr. Davies. We provide all the addiction services for 
Volusia and Flagler County.
    [The prepared statement of Dr. Davies follows:]
    [GRAPHIC] [TIFF OMITTED] 95555.131
    
    [GRAPHIC] [TIFF OMITTED] 95555.132
    
    [GRAPHIC] [TIFF OMITTED] 95555.133
    
    Mr. Souder. Thank you. Next witness is Professor Paul 
Doering, a distinguished service professor of pharmacy 
practice, College of Pharmacy, University of Florida, who 
informed me that if his son had been playing for the Colts, 
they would have been in the Super Bowl rather than the 
Patriots. Unfortunately he switched teams.
    Mr. Doering. To the Stealers.
    Mr. Doering. Good afternoon, gentlemen, my name is Paul 
Doering and I am distinguished service professor of pharmacy 
practice at the College of Pharmacy, University of Florida, in 
Gainesville, FL. And it is my honor to be here this afternoon.
    You know I went to pharmacy school in the 1960's and 1970's 
and they say if you were a member in the 1960's and the 1970's 
you were not there. I remember them vividly, because that was a 
time in which I came to the stark realization that the very 
same drugs that help people ease pain and make the suffering of 
surgery a little bit easier are the same ones that just as 
easily can cause severe injury and death when used 
inappropriately. This reality really hit home when I 
volunteered my time to assist in a methadone maintenance 
program for heroin addicts, a program that was being run out of 
Shands Hospital in Gainesville.
    You know, in a strange sort of way, we as pharmacists are 
in denial: we do not like to admit that the very same 
pharmaceutical drugs that might be the answer for one person's 
problem is the problem for the next person.
    Working with heroin addicts and focusing on the drugs they 
used, is suddenly realized, kind of like a light bulb going on, 
that as a pharmacist I do know something about drug abuse after 
all. Since that time, I have been spending a substantial part 
of my career trying to help people to understand the downside 
risks that accompany the use of all drugs, but especially the 
recreational use of prescription drugs. Now, after all morphine 
is morphine is morphine, whether it is used to get high or used 
to relieve the pain of surgery. Its dangers are the same as are 
its bad effects when combined with alcohol or other drugs, and 
the risks associated with taking more medicine than prescribed.
    Today, there has been a shift away from the abuse of so-
called street drugs, more toward the pharmaceutical drugs. And 
although abuse of the OTC drugs is a growing problem, perhaps a 
point for discussion on another day, the problem of 
prescription drug diversion is what is wreaking havoc all 
across our nation. I will not repeat the statistics that you 
have heard over and over again, but we all agree that this is a 
huge problem.
    It is especially a problem for pharmacists, because we find 
ourselves smack dab in the middle of this issue, and let me 
tell you why. The Code of Ethics of the American Pharmacists 
Association states, among other things the following: A 
pharmacist promotes the good of every patient in a confidential 
and compassionate, and confidential way. Pharmacists place 
concerns for the well-being at the center of professional 
practice. In doing so, a pharmacist considers needs stated by 
the patient as well as those defined by health science. A 
pharmacist is dedicated to protecting the dignity of the 
patient. And with a caring attitude and compassionate spirit a 
pharmacist focuses on serving the patient in a private and 
confidential manner.
    Now, unfortunately, we spend an inordinate amount of time 
trying to sort out the patient presenting a narcotic script for 
some legitimate purpose from the patient who has obtained the 
prescription under false pretenses or who alters the 
prescription or outright forges the prescription for the 
purposes of abuse or resale. Unfortunately, most of us as 
pharmacists are not experts at handwriting analysis nor have we 
gone to the police academy to hone our skills at conducting an 
investigation. We are taught to trust the patients we serve and 
to be ``caring and compassionate'' as our Code of Ethics 
requires. Imagine our shock and frustration when a vial of 
pills from our pharmacy is found at the scene of a death 
investigation where a young adult has died from pills up and 
injected. Ours is a careful balancing act: while we want to 
keep drugs out of the hands of those who have no business 
having them, we must provide them with the caring attitude and 
compassionate spirit patients so rightly deserve.
    One of the most valuable tools that we, as pharmacists have 
to combat the problem of drug diversion is open and honest 
communication. This includes communication between the patient, 
the doctor, the law enforcement community, and the regulatory 
boards of other health professionals. But unfortunately, while 
we do have laws in place to guide the pharmacist, sometimes 
laws can be difficult to apply on a daily basis. For example, 
Federal law tells us that the tenets of a lawful prescribing 
dictate that, to be lawful, a prescription for a controlled 
substance must be: No. 1. Issued for a legitimate medical 
purpose. No 2. By an individual prescriber acting in the usual 
course of his professional practice. No. 3. And documented in 
the medical records.
    Now, all this may sound straight forward but, we as 
pharmacists, have difficulty determining if the medication is 
ordered for a legitimate medical purpose. Furthermore, we may 
not know what constitutes the usual course of practice for one 
physician versus another type of specialist. And we almost 
never have access to the patient's medical record.
    Looking at the problem from the patient's perspective, the 
therapeutic imperative should likely prevail. This theory 
compels the pharmacist to always dispense opioid analgesics 
when they are appropriate for a patient. On the other hand, the 
regulatory imperative commands us to never dispense opioid 
analgesics when they are inappropriate. And now matter how hard 
we try, no pharmacist can be faithful to both imperatives.
    I think it would be wonderful if we had some technology 
that would allow us, for example, that somebody would give 
their fingerprint on some type of technology or pad that would 
validate and verify through some monitoring system. And I urge 
the adoption of such kind of system but only when the 
safeguards of confidentiality and privacy are indicated.
    And I have longer comments that will appear in the record, 
and I appreciate your attention, today.
    Mr. Souder. Thank you for coming and we will make sure the 
full statement is submitted and also, any additional materials.
    Our next witness is Karen Kaplan, president and chief 
executive, Last Acts Partnership.
    [The prepared statement of Mr. Doering follows:]
    [GRAPHIC] [TIFF OMITTED] 95555.134
    
    [GRAPHIC] [TIFF OMITTED] 95555.135
    
    [GRAPHIC] [TIFF OMITTED] 95555.136
    
    [GRAPHIC] [TIFF OMITTED] 95555.137
    
    Ms. Kaplan. Thank you, Mr. Chairman and members of the 
subcommittee, I am, as you said, Karen Kaplan, president and 
chief executive officer of Last Acts Partnership. Last Acts 
Partnership is a national not-for-profit organization that is 
dedicated to improving the care and caring near end of life.
    You have heard compelling testimony today, and my message 
is one of balance. I appreciate the opportunity to testify 
concerning prescription medications, the opioid analgesics. You 
have heard they are controlled substances and they are 
controlled for good reason, but they are also indispensable 
medications for the relief of severe pain, especially pain near 
the end of life.
    My remarks focus on the critically important need for 
balance, balance in the effort to address use, abuse, and 
diversion of the drugs. We must ensure that prescription pain 
medications are available to patients who need them even as we 
do all that we can to prevent these drugs from becoming a 
source of harm or abuse.
    Under-treatment of pain is a major public health crisis. 
Medical experts agree that 90 to 95 percent of all serious pain 
can be safely and effectively treated. Yet, there is 
overwhelming evidence that under-treatment of pain is pervasive 
throughout our health care system. Inadequately managed pain 
was reported by approximately 50 percent of seriously ill and 
dying hospitalized patients. In nursing homes nearly 300,000 
patients are in pain on any given day as we are talking here 
today. More than 40 percent reported being in continuous pain 
for many months. The people who rely on these medications are 
our mothers and our fathers and they will be us.
    We have made some progress in recognizing pain as a serious 
medical problem. For example, the Joint Commission on 
Accreditation of Healthcare Organizations added pain as the 
fifth vital sign, and you have heard about that already.
    In 2000, Congress and the President declared this as the 
decade of pain control and research. So we must ask, with all 
the advances in pain medications and treatment, why is under-
treatment of pain still so prevalent in the United States?
    The answer is complex, but two major obstacles are 
particularly relevant to today's hearing. The first is a lack 
of physician education, a lack of physician education in 
palliative care. American medical schools provide little or no 
required education in palliative care according to a 2001 
Institute of Medicine study. Only 1 of 125 medical school are 
accredited by the AMA offered pain management as a separate 
course. This appalling situation must change if all physicians 
are to gain competency in pain management--and all must.
    The second major obstacle to appropriate pain treatment is 
good physicians' fear of investigations by medical boards and 
law enforcement agencies, for prescribing opioids. This 
chilling effect was demonstrated by a recent survey of 1,400 
New York State physicians, 30 to 40 percent of whom report that 
fear of regulators has influenced their prescribing practices.
    Another face of this, a study of New York City pharmacies 
found that many, especially those in non-white neighborhoods, 
had inadequate supplies of commonly prescribed opioids. The 
reason cited by 20 percent of the understocked pharmacies in 
minority communities, was fear of investigations by the DEA. 
These practices based in fear can be found in every city, they 
may reduce some drug diversion, and abuse but they also condemn 
thousands of patients with intolerable pain to needless 
suffering.
    Opioids are absolutely essential to good pain management, 
physicians must be knowledgeable about their use and should not 
hesitate to prescribe them when appropriate, for fear of 
reprimand or reprisal.
    So, I return Mr. Chairman to the need for a balanced 
approach, one that recognizes the need to reduce abuse and 
diversions of these drugs but one that also recognizes that 
people in severe pain, particularly men, women and children 
with terminal conditions, must have access to medications that 
can ease their pain and help give them and their families 
peace.
    In furtherance of this goal, Last Acts Partnership and 20 
other national pain and health organizations joined the DEA in 
October 2001 to develop a consensus statement regarding 
prescription pain medications. It reads in part: ``Both health 
care professionals and law enforcement and regulatory personnel 
share a responsibility for ensuring prescription pain 
medications are available to the patients who need them and for 
preventing these drugs from becoming a source of harm or abuse. 
We all must ensure that accurate information about both the 
legitimate use and the abuse of prescription pain medication is 
made available. The roles of both health professional and the 
law enforcement personnel in maintaining this balance is 
critical.''
    This statement is attached to my testimony, it has been 
disseminated widely, used in many different settings. There are 
now 42 organizations participating in what is known as the Pain 
Forum. Many also belong to the RX Alliance chaired by former 
Mayur Guiliani, also looking for ways to invigorate balanced 
approaches.
    We continue to seek ways to advance this dialog, and to 
provide a comprehensive answer to this. We have recently 
developed and will be publishing shortly a question and answer 
guide for non-pain specialists, physicians, pharmacists, and 
law enforcement personnel.
    I applaud your work here today, I appreciate the 
opportunity to testify, and would be happy to answer any 
questions you have.
    Mr. Souder. Thank you.
    Our clean-up hitter for today, is Dr. Kollas, who is 
medical director, Palliative Medicine--in Indiana, anything 
over five words we have to wrestle with--Head of the M.D. 
Anderson Cancer Center in Orlando, in Orlando Regional Health 
Care.
    [The prepared statement of Ms. Kaplan follows:]
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    [GRAPHIC] [TIFF OMITTED] 95555.142
    
    Dr. Kollas. Thank you. On behalf of the Cancer Center and 
Orlando Regional Healthcare I want to thank Chairman Souder, 
and the subcommittee for inviting me to testify today. I would 
also like to thank Representative Mica and his office for their 
support and thank those who contributed to the research that I 
will be presenting in part.
    My testimony will focus on the views of cancer patients 
regarding their experiences with pain medications. My goal is 
to give them a voice in this subcommittee's discussions. We 
surveyed 1,200 randomly identified patients who received care 
at the M.D. Anderson Cancer Center Orlando, between August and 
November 2003. The details of the methodology are available in 
the written testimony that I submitted earlier.
    I want to point out that 52 percent of cancer patients 
reported that they experienced pain daily; 41 percent agreed 
that pain interfered with their ability to work and be 
productive; 20 percent felt that they could not preform routine 
activities, these include getting dressed, driving the car, 
shopping for groceries due to pain; 43 percent of them 
expressed concerns about using pain medication because its 
potential for addiction. I would also note that of those 
patients who had concerns about addiction, they reported pain 
twice as often as those without concerns.
    The results confirmed that many cancer patients suffer from 
pain on a daily basis, and that it affects the ability to live 
their lives in a free and productive manner. With regard to 
OxyContin and their pain experience, about 41 percent of the 
respondents had used OxyContin to manage their pain, whereas 59 
percent reported using other opiate analgesics for their pain. 
In the first group, 82 percent reported the OxyContin relieved 
their pain, but 72 percent in the latter group responded that 
they received pain relief with other opiate medications. 
Additionally, 53 percent of those taking any opiates agreed 
that opiate analgesics were the only medications that helped 
their pain.
    These results suggest that opiate analgesics offer 
effective relief for cancer pain even when other analgesics 
failed. They also suggest that some cancer patients may have 
better control with OxyContin than with other opiates, although 
I would strongly caution the committee that this was not 
intended as a formal comparison of pain medications. And rather 
reflects the view of the patients that we surveyed.
    Additionally we asked some questions about the cancer 
patients' experience with the media and OxyContin, 43 percent 
disagreed that the media had adequately addressed the issue of 
cancer pain, but we found no relationship between concerns 
about addiction and attention to media coverage. Given this, I 
would suspect that cancer patients value their own pain 
experience more than what they read, hear, or view in the 
media. Fear of OxyContin or other opiate analgesics is a 
complex multi-factorial phenomenon, not simply the result of 
intense media coverage.
    This subcommittee has accepted the challenge of preventing 
diversion and abuse of prescription medication while preserving 
legitimate access to those medications. Our survey of cancer 
patients reaffirms that opiate analgesics, including OxyContin, 
offer relief for pain often more effectively than non-opiate 
analgesics. In spite of media attention to prescription pain 
medicines, cancer patients seem to base their opinions of 
opiate analgesics on their own experiences.
    In light of our patients' view, I would offer several 
guiding recommendations to the subcommittee regarding it 
mission. Because cancer patients need pain medication, we would 
discourage regulatory efforts that would reduce legitimate 
access to opiate analgesics, including sustained release 
oxyocodone. However, we recognize clearly that the government 
has an obligation to protect those who suffer from the 
diversion of use of analgesics.
    I would applaud this subcommittee's efforts to develop 
regulatory mechanisms that would protect these people. I would 
also remind the subcommittee that those who misuse prescription 
medications often suffer from underlying untreated psychiatric 
illnesses that influence their drug abuse. Successful solutions 
to the problem of diversion and abuse should take this 
phenomenon into account.
    Last, I would encourage the subcommittee to continue 
challenging medical professionals to help create new policy 
through frank discussions. We believe that education in pain 
management helps medical providers to recognize and avoid 
diversion or misuse of prescription drugs. I would add at this 
point that I feel medical providers should welcome the 
opportunity and the responsibility to serve in this battle to 
help prevent misuse and diversion of prescription drugs.
    I would strongly encourage the development of other 
strategies that emphasize an educational approach, and I would 
specifically cite House Resolution 1863, the National Pain Care 
Policy Act of 2003.
    I would also note that electronic monitoring which is being 
considered in Florida has shown to be effective in other 
States, including a specific example of Connecticut. The only 
concern I have with regard to electronic monitoring has to do 
with HIPAA violations, and we have talked about some of those 
issues, at least in a preliminary fashion, today.
    Although the subcommittee faces formidable challenges, I 
conclude my testimony on a positive note. When we mailed our 
surveys, we hoped that our patients would entrust their voice 
to us, and they did so. They embraced the belief that their 
views and concerns would reach your ears, and now they have. 
Although we face a difficult task, we face it openly and with 
resolve to succeed. Because of this, I have renewed hope for a 
better future for all patients in pain, and I would be very 
happy to entertain you questions.
    Thank you.
    [The prepared statement of Dr. Kollas follows:]
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    Mr. Souder. Well let me start off with just a couple of 
things to clarify for me, since I am medically challenged. My 
wife is an occupational therapist and she does the thinking in 
this area, and I kind of wander in and she is always kind of 
envious that I am at the hearings and she thinks that I am a 
ignoramus on the subject and she knows the details. But you 
gradually pick up bits and pieces, just enough to be dangerous. 
But I want to clarify a couple of things.
    My mother-in-law recently died of cancer. Her pain 
definitely was greater in the last stages than it was earlier, 
is that usually true?
    Dr. Kollas. It can be, we see that commonly. It depends on 
the cancer.
    Mr. Souder. But it is not always true?
    Dr. Kollas. It is not always true, but it is true very 
often.
    Mr. Souder. And so, would the pain killer use likely 
escalate as you go through cancer treatment, or increasingly is 
the same thing being prescribed all the way through?
    Dr. Kollas. No, the use of the medication may escalate. 
Actually you bring up a point that I wanted to make earlier. 
Physicians are sort of used to dealing in population medicine, 
it is what they teach us in medical school. They want us to 
view people in categories of diseases if you will. So we think 
of people as having hypertension, or we think of them having 
diabetes, or we think of them having cancer.
    To do good pain management you have to abandon that view 
somewhat and look at people as individuals. Every one is 
different. So the right dose of a pain medication for one 
person may not be the right dose for another patient.
    Certainly, you are going to see general trends, and it is 
not uncommon for patients with cancer at the end to have more 
difficulty with pain. And in fact in my experience, the few 
people that we have seen on dosages of pain medication of 
opiate medication that would stagger the subcommittee's members 
all occurred related to end of life care. Given that, that is 
why it is hard to answer that question, it depends upon the 
individual patient. And it also raises the importance how 
physicians need to be trained to take that into account. It is 
a very different approach than what we learned in medical 
school, where it is very disease based. We try to look at--
palliative medicine particularly is focused on relieving 
suffering in multiple dimensions, and that is a very different 
approach.
    Legislation that would encourage that type of education is 
extremely important and I would argue that physicians should be 
asking to be empowered to take a more active role in this, to 
help prevent misuse and diversion medications, because clearly 
the more you know, the better you are able to do those things. 
We might get fooled by patients once in a while, but it is a 
lot tougher to be fooled by a patient when you know more about 
what the techniques are used to divert medications.
    Mr. Souder. If a cancer patient is younger and mobile even 
if it may be likely failed, is the mere factor of their 
mobility, their ability to hold a job--well, let me first ask a 
fundamental question about OxyContin.
    Dr. Kollas. Sure.
    Mr. Souder. Does this impact your ability to do certain 
types of work if you are taking a dose?
    Dr. Kollas. It can, it is individualized. Let me give you 
an example, I have a patient who is 48 years old. She has 
metastatic breast cancer. I asked today--I did not ask today 
but I asked if I could discuss her case with you today. I saw 
her in the hospital about 2 weeks ago, she was having a 
stabilization surgery to help her spine, because she has 
metastatic disease to her spine. At any rate, she works for one 
of the technical companies that is based in the Orlando area. 
She has been able to continue working at her job, awake and 
alert despite the fact that she takes 640 milligrams of 
oxycodone every 6 hours. When she gets a refill prescription 
and she goes to the pharmacist, she tells me I am very scared 
because look at all the tablets that I take. Yet, she is awake 
and alert.
    Now, when she comes to see me, I document that in my note, 
I do a physical examination. The physical burden of her cancer 
is just tremendous, I mean the surgery that she underwent is a 
laminectomy, she had a spinal fusion involving four segments of 
her spine. Afterwards we actually had to convert her from oral 
medication to medication that she could use intravenously, 
using a portable pump. Because she is to the point where 
literally it becomes a physical problem to have to take that 
many pills. They could get stuck together and cause her to have 
a intestinal obstruction.
    So, when you ask me the question are people able to 
function cognitively when they take OxyContin, my answer is 
yes, but everybody is different. Some patients do better than 
others.
    Mr. Souder. Let me ask, are there restrictions in driving 
in Florida?
    Dr. Kollas. Yes, there are restrictions in driving in 
Florida.
    Mr. Souder. Is it not also true that alcohol has a 
different impact on different people?
    Dr. Kollas. Absolutely.
    Mr. Souder. And yet, our laws that regulate do not respect 
that difference. In other words, we do not say some people can 
handle three beers, and some people can handle two beers 
because they have to protect on the whole.
    Dr. Kollas. Sure.
    Mr. Souder. Would you not agree, and one of the things--to 
me, this debate is not predominately about people at the end of 
life or who are probably--in other words, when we dealt with 
certain waivers, for side effects on AIDS, for AIDS patients--
--
    Dr. Kollas. Right.
    Mr. Souder [continuing]. We basically said they are dying, 
if they are willing to take the side effects, because they are 
dying.
    Dr. Kollas. Sure.
    Mr. Souder. The question here is that predominately on the 
moderate pain, or other types of things other than cancer. 
While it is a concern that we do not pass laws--but quite 
frankly, one thing, Ms. Kaplan, that you can probably be 
relieved of after today is that doctors and pharmacists do not 
have to worry about being prosecuted by DEA, that if anything 
for them to use that as excuse, simply is not valid around the 
country.
    One of the things I wondered, if I can take it along--I 
wanted to put that point into the record that I do not view 
this hearing as predominately related to the cancer, or the 
highest risk, or where the pain is greatest. I view this as we 
are trying to identify in the middle and I would like to have 
one more comment. I also, wonder, Ms. Kaplan, whether there is 
a concern of the people who say that they are worried about 
prescribing, whether you have discovered they are worried about 
being sued. I would assume there is more concerns about the 
losses and the malpractice then there is about the DEA, 
because, the fact is that we are not doing that much in the 
country on law enforcement.
    Ms. Kaplan. I think that I would agree that the issue of 
the chilling effect may be largely a perception issue, and 
requires some fairly active public education on the part of the 
DEA, and they are indeed addressing that issue.
    In terms of the second part if you would restate the second 
part of----
    Mr. Souder. Do you not believe that one of the things that 
causes doctors not to prescribe is that they are concerned 
about lawsuits?
    Ms. Kaplan. I think that is not the case in this situation, 
doctors in fact are being sued successfully for under-treatment 
of pain. So that should be a push in the other direction. There 
clearly is a malpractice crisis in the country. I do not think 
this plays--fear of over-treating plays a large role anymore in 
that.
    Mr. Souder. That is kind of a different angle on it. Mr. 
Mica.
    Mr. Mica. Well, first I want to thank Fred Pauzar. I have 
known Fred for a number of years through business, I cannot 
imagine the pain and the absolute incredible loss he has 
experienced and there are other parents and loved ones out here 
that have lost people they care about.
    This hearing is not going to bring anyone back. What it 
will do and I compliment you Fred and others who pursue this, 
is to try to get government to respond to a situation of 
prescription drug abuse, and bad people who have also gamed the 
system and caused untold pain, and created an incredible 
challenge for us. Unfortunately, I have known too many parents, 
I know Fred, and I have known others who have lost their 
children in the community. I could name names of parents of 
kids, I hope I do not have to do another one of these hearings 
ever, or request a hearing like this.
    But it is sort of a challenge of our times, this is what--
we are talking about this particular narcotic that is available 
since 1995. We were talking about that earlier, how long has it 
been available, and then if you look at the statistics, they 
are off the chart. I read--I knew the problem, and I read the 
same day of Chris's death that we announced the hearing. Again, 
nothing is going to bring back your son or some of the others, 
but from this hearing and from your very admirable efforts, 
hopefully we can bring some of this situation under control.
    And this is the process that works, sorting it out, work 
with my colleague, Dr. Norwood, to have legislation pending, 
and I have learned that there are other proposals before 
Congress, and maybe we can craft something. It is also obvious 
that people do need remedies for pain. I have been through the 
same thing, Mr. Souder, with family members that have passed 
away in the last couple of years, and had to endure incredible 
pain and seeking relief. We want to achieve a balance, but we 
also want to achieve a protection so that we do not have anyone 
suffer the way some of the folks who came out today have.
    So, again, not so much as a question, but a statement to 
say thank you for your testimony.
    From the pharmaceutical standpoint, again, I think we are 
trying to achieve a balance and protection and some system. I 
do not know if you were here, when I relayed that we had 
several demonstrations projects in the Medicaid area to try to 
come up with software that will resolve this. Are you familiar 
with any of those.
    Dr. Doering. Yeah, as a matter of fact one of the things I 
did not tell you another hat that I wear, I do a lot of 
consulting work in cases that are being prosecuted. The one 
that Mr. McDonough talked about earlier in Pensacola, I 
testified twice in that case. I was involved in several cases 
close by and I remarked to one of my colleagues at the break 
that it was interesting that a current case that I am working 
on in the panhandle was brought forth by Medicaid fraud.
    Now, you do not typically think of them as, or I do not, as 
the enforcement arm in criminal activities involving narcotic 
drugs. But it is the Medicaid fraud, and apparently they have a 
system that others do not, where they can look on paper and say 
whether it is, wow, look how much we are spending or wow, look 
how much they are prescribing. But that current case has 
evolved into a well-coordinated multi-jurisdictional type of 
task force.
    Now, as you well know, prosecuting these kinds of cases is 
lengthy, it is costly, and sometimes people are falsely 
accused. I have a new respect for the legal system. I was a 
consultant in a case with DEA that just pled actually a doctor 
there in Arizona; Phoenix, AZ; Tuscon, AZ. And I do not want to 
tell these taxpayers how much of their money was spent that I 
know that on April 15 that is going to be a large part of 
expenditure. Is it worthwhile? Absolutely. If one bad doctor, 
one bad pharmacist it taken off the street, it is worth the 
effort.
    But, you know, I believe in the 80/20 rule. I believe that 
these 12 prescribers that we heard about earlier today, I mean 
if they are really accounting for that much of the diversion 
and the bad prescribing and the deadly use of these drugs, that 
is where the focus ought to be. I learned a long time ago, you 
look where the light is, and if that is where the light is, I 
mean with all due respect to my colleagues on the left here who 
made a very convincing presentation, I do not think that is 
where the light is. I think the light is with people who are 
either fully educated who are cradled with the D's that you 
mentioned, that are criminally involved. We have to take them 
off the streets and put them in jail.
    Dr. Kollas. May I just add something?
    Mr. Mica. You want to respond?
    Dr. Kollas. One of the points that I wanted to emphasize is 
just that. Realize that I am involved in treating a group of 
patients, when I say I relieve their pain it has the same sort 
of analogy that I would use for a politician kissing a baby. 
You make cancer patients' pain better, people are going to say 
that is a good thing. That is pretty close to a no-brainier. I 
think there is a problem with physician involvement in 
diversion and misuse of these medications. You guys keep 
talking about these 12 physicians in Medicaid. I live in 
Florida, so I get to read the paper and one the physicians that 
they were talking about was writing prescriptions for patients 
who were dead.
    Please hold the physicians accountable when they do this. 
That is clearly criminal, and it gives everyone else who is 
trying to do an honorable job of this, a bad name. And it is 
difficult enough, I mean, you know, looking at people in an 
individualized fashion is very labor intensive, it is 
important. I am very passionate about what I do and I view it 
as an honor and privilege to be able to do it. But, please when 
you see physicians that are clearly doing it related to 
obtaining money or obtaining some other favor for writing a 
prescription, put them in jail. We will be safer and we would 
not have to have these meetings anymore.
    Mr. Souder. Dr. Norwood.
    Dr. Norwood. Mr. Chairman, you are to be commended on this 
hearing, and especially for the witnesses that we have had 
testify this morning. I think it has become very clear to all 
of us in the room and all of us on the dias up here that this 
is a very complex, it is a very difficult problem.
    All of us are in great sympathy with you, Mr. Fred Pauzar, 
and want to do anything we can to see that kind of thing cannot 
happen again.
    On the same token, Ms. Kaplan, I associate with your 
remarks a lot, what you are saying about under-prescribing for 
pain is equally important, and it is particular important if it 
is your mother dying of cancer. It gets to be a lot bigger 
subject matter at that point. I am in great sympathy with the 
majority of physicians who get their profession black-balled 
because of some 10, 12, whatever the number is really, really, 
bad people in my view. I agree with you, Doctor, they would 
serve out the rest of their days practicing medicine in prison. 
Those that would violate the Hippocratic Oath I do not think 
very much of, is probably the best way I can say it without the 
chairman having a fit.
    But the poor physician is caught in the process of if I do 
I get sued; if I do not, I get sued, and that is not a good 
situation.
    I associate with your remarks when you are talking about 
the code that pharmacists have to live by in dealing with 
confidentiality. That is going to be one of the real difficult 
problems with us in dealing with this problem. Obviously, if we 
are going to solve it, somebody has to have a data bank. I do 
not think the Federal Government needs a data bank, but I think 
Florida does, and I think they need to be able to talk to the 
data bank in Georgia, because you can run back and forth 
between Tallahassee and Valdosta and load up.
    But who actually gets to go into that data bank. The 
liability questions of that are gigantic, and very difficult to 
solve.
    Last, Doc, what do you do, I know you know--you know who 
the pill shops are. I know in my town, or I used to when I was 
really into all this. What do you do with that information, 
when you know that?
    Dr. Davies. I do not do a whole lot with it, right now.
    Dr. Norwood. Why not?
    Dr. Davies. It would just be--I do not know if there is a 
forum to go to with it. The State rules, the laws are not real 
clear to me. And the source of my data--there is so much stigma 
around addiction and around addicts, although plenty of my 
patients are us, they are not street level addicts.
    Dr. Norwood. You do not have to do the investigation. Are 
you not morally responsible to at least let DEA know something 
is going on here that is wrong. It is their job to do the 
investigation. And it is the court's job to make the 
determination of innocence or guilt. But should you not call up 
your DEA folks, and say something is not right over here on 
Third Street.
    Dr. Davies. I would feel a lot better about that if I had 
access to real data and real numbers. And not just what they 
are going to tell me is hearsay from patients. I mean, I have a 
great concern about it and that is precisely why I brought it 
up.
    Dr. Norwood. I knew you did, and I am not trying to 
criticize you about this, I am just saying that you guys know, 
I know you know. You may not have proof but that is not your 
job. But you know what is going on out there in your community, 
you know who the bad guys are, and all I am saying is spread 
the word. Let those agencies that are responsible for dealing 
with that, deal with that. But there are so few employees at 
the DEA, if they do not get a little help from us out in the 
field, if we do not direct them a little bit, when we know bad 
guys are out there, it just takes them that much longer if they 
ever catch them and stop them. And if the people are not 
guilty, fine. That is what the whole system--that is what our 
justice system is all about.
    Mr. Chairman, I just congratulate you. There are a couple 
of bills going around, being worked on in Washington and they 
do not all necessarily take the same course, but all of them 
involve data collection, so somewhere out there we can find out 
who is prescribing what. Some people want to do it on a Federal 
level, I do not fit into that category. I really think it is 
more of a State thing.
    But I pledge to work with you and Mr. Mica to do whatever 
we can do there to solve this problem.
    Mr. Souder. I want to thank Congressman Mica for being 
persistent in raising the subject and making sure we had this 
hearing, to Mr. Norwood, for his leadership in the area, and 
both of them for their chairmanship in multiple areas in 
Congress.
    I want to make sure that in the record we note a couple of 
other things.
    First, Dr. Davies, I really like the five D's because it 
illustrates how this is not one solution. In other words, for 
the data, that is clearly an education effort in the form of 
HHS and other institutions doing more to get the information 
out. We have heard a lot about that today. But the duped, the 
dishonest, the dysfunctional, disabled all require different 
approaches. There may be some clustering and all those are part 
of this problem.
    I think a hearing like this helped us clarify where some of 
the targets should be in larger targeting. We do not know that 
all 12 of those individuals are guilty of any violation, they 
may in fact have more Medicaid patients, which may be that is 
why they were among that. They may be among the inner city 
urban area, for example. There were certain suggestions implied 
that they certainly should be the places you start. That there 
are certain things you might look at at the Federal level, but 
in that as our committee having both authorizing and direct 
oversight over the national ad campaign, over ONDCP and HIDTAs, 
we understand that DEA and our dollars are stretched very 
narrowly and that the south border right now is so porous that 
much of that has to be focused on and the Carribean. And we 
cannot go off into each new hot thing that is the focus, and 
divert large amounts or we will get none of them licked. We 
have to kind of focus in but we also have to have secondary 
efforts in emerging threat efforts inside that. And we are 
helping identify that with this hearing.
    But let me say something and end this on a less than 
comfortable note. That fact is what Mr. Pauzar raised was more 
complicated, and that was not just about massive diversions, 
not just about people who were former addicts, who use this 
which make them higher risk, not just about big abusers. But 
are there risks to individuals, because we are going down to 
moderate use, which is much more explosive than what we can 
agree on here, and we have obligations in our society to look 
at some of the traditional ways of prescribing. The secondary 
use of those drugs, the interaction of those drugs, and the 
dependencies and risks that are occurring beyond the kind of 
OK, these 12 people are terrible, because your son probably was 
not getting it from 1 of those 12 people. He probably was not a 
previous addict, and then all of a sudden he is dead, and we 
have another class here that is much more complicated, he was 
not dying of cancer, and these, this zone is really where the 
political difficulty comes. We will probably be able to address 
the more egregious things. Do you want to add something?
    Mr. Pauzar. Mr. Chairman, thank you for that. You are 
correct, my son was not a drug addict, and he was not taking 
prescriptions that he obtained from 1 of these so-called 12. 
Twelve is an arbitrary line that was drawn, simply because the 
gross magnitude of the quantity of prescriptions that were 
being written presumably illicitly by those 12 doctors was so 
egregiously horrific that it stands out. But that does not mean 
the number is 12, the number may be 100, it may be 20. There 
are a number--a small number fortunately, a minority of 
physicians who are over-prescribing and prescribing 
inappropriately.
    But your remarks that this is a very complex situation is 
very apt. The solution is not one thing. It is not going to be 
a tracking bill, that requires tracking. It is not going to be 
more dollars for DEA, or better education for people at DEA 
about what really is going on in some of the burgeoning new 
markets of drugs, illicit drugs and prescription drugs that are 
being abused. It is a very complex three dimensional puzzle and 
it requires communication between the agencies, and it requires 
action to be taken legislatively, and it requires action to be 
taken on a State level too, where the boards of medicine and 
others are regulating the physicians.
    Because it will not stop; simply to track the information 
and to know that it is there, is not an answer. We had an awful 
lot of data before we lost our last space shuttle, but that 
data just was not analyzed and it was not acted on correctly. 
So, the organizations that are vested right now with power and 
with a mandate to act, have to be informed and they have to 
communicate with one another, and there has to be stronger 
teeth in the legislative attempts that you take. And certainly 
drugs like OxyContin have to be taken away from moderate pain 
relief, because if anything has been shown here today, that has 
been talked about today by everyone is that we do not want to 
deprive terminal cancer patients of OxyContin. You do not want 
to deprive people who are severely afflicted with pain from 
those arsenals that are available to them to deal with that 
pain to make their lives manageable, but you want to take 
people who can take Tylenol instead and make sure they never 
receive a script, that they are never given a prescription for 
something that might well kill them as it did my son.
    So, it is an extraordinary complex problem, and I 
appreciate your attention on this but I also appreciate the 
fact that it is going to take a lot more than this hearing and 
a lot more than one piece of legislation to cure it. But every 
day that goes by just in this State alone, I am not sure--is it 
one person who dies Congressman Mica or is it 10, in Florida? I 
know that what we have, based upon the statistics that we see, 
even in the time we have been talking here, there had probably 
been one to two deaths in the State, in this State alone, from 
OxyContin or oxycodone. So, I am enormously distressed by the 
problem because of my own loss, but I am more distressed, and 
believe it or not I am more distressed by what I see tomorrow. 
Because every day that goes by without decisive action means 
that there are more parents like myself.
    Thank you.
    Dr. Kollas. I just wanted to add something to that, and I 
hate to add another layer of complexity on your task. Using 
OxyContin, for example, for moderate pain, on the surface it 
seems to be something that is a bad idea, we should not do that 
there are other medications available. What I would do is 
caution you when you approach it that way. There are over-the-
counter medicines that are every bit as lethal as OxyContin, 
people have not chosen to abuse them because they may not have 
the same sort of effects that opiate medications do. But if you 
take more than 8 grams of Tylenol you can die from liver 
disease. If you take too much Advil you can die from renal 
failure. Sometimes you are forced to use medication for 
moderate pain when you would rather use something else. If 
somebody has difficulty with renal insufficiency than a 
morphine-based medicine might not be the best choice for them 
when they have moderate pain, they may have an allergy. If they 
are hemophiliac they may not be able to take medicines that 
aspirin or that are nonsteroidal anti-inflammatory drugs.
    The point that I want drive home to the panelists is that 
there is a certain level of expertise that is involved in pain 
management. You know I went to medical school, I know what a 
cardiac cathererization is, I know what they do when they do 
the procedure. I am not a cardiologist, I do not do them. You 
would be nuts to let me do a cardiac cath on you, OK. What I do 
know is that I have special training that allows me to handle 
something that is medically sophisticated, that many of my 
colleagues do not have. So, I really think that part of what 
you need to consider is, who is able to prescribe these 
medicines, and what is their amount of training and if it is 
that all doctors should be prescribing pain medicine because 
pain is such a broad problem, then all doctors need more 
education in pain medication and in pain management. And if you 
want to say there is specialized cases in pain management that 
requires special expertise then it would be wise to recognize 
that. It would be wonderful if there was American Board of 
Medical Specialities acknowledgment of palliative medicine as a 
specialty. There is not yet. I would love to see that happen 
and I think that would go a long way to help with some of these 
issues.
    But understand that this is an important area of medicine 
that is more complex than--I think you have an appreciation of 
it, but it is more complex than you even realize. And please 
use the resources--clearly from today's hearing, there are many 
resources available to you and we are all committed to making 
this problem better.
    Mr. Souder. Well, I appreciate those comments and as 
somebody who is, as I have said several times, a very strong 
supporter of doctors and the medical industry as a whole, let 
me again make this statement. Everybody would like best to be 
left alone, small businesses would like to be left alone, 
everybody would like to be left alone. And I know that in 
health care this is something we hear on abortion law, it 
should be between patient and doctor, but you know what when 
society makes the decision, there are restrictions on it. Same 
with illegal narcotics, and there is a point, for example, as 
we try to work through incredibly difficult issues in Medicare, 
Medicaid payments and now the private sector mimics it. What 
kind of health insurance--Dr. Norwood, has been involved in 
this, trying to redo health care since he has gotten elected. 
And we run into lawsuit questions, where do we make 
compromises. But when the Federal Government crosses the point 
where we are carrying most of the health care cost than the 
private sector, which was not doing cross transfer and now all 
of a sudden you have HMOs and others who are necessarily 
already restricting the medical profession to make necessarily 
the kind of in depth consultive type traditional, this is my 
doctor, this is the patient, where you are trying to run lots 
of different people through where there is not heavy 
backaground checks. And then all of a sudden, we have an 
explosion of 10 deaths of a day in the State of Florida, 
related to one thing, I am sorry, it is not just doctor-patient 
anymore. It is a lot more complicated than that, and we need to 
make sure we do not overreact and overstate it.
    But there are going to be controls, because of who is 
paying for it, because of the reactions in society and then we 
have to make sure that we do not do irreparable harm to others 
who are benefiting, but we have heard testimony today that this 
has had greater than any other prescribed drug in the number of 
deaths. So to not act, suggests some irresponsibility. And one 
of those things is to look at yes, moderate pain is something 
that requires maybe certain waivers. We should not make it so 
blanket, but it is not something that--we are not living in a 
just leave us alone world at this point. And no group likes 
that, and I think we have as great a danger of over-regulation 
as under-regulation, but at a ceratin point you say this as 
reached the point, a threshold where action is going to be 
required. And I would say that clearly this coming.
    Now one other thing, we are dealing with ephedrine and 
things that go into aspirin and so on are some of the main 
components of meth labs and clearly even as Mr. Doering said, 
look there are over-the-counter problems right now too, it is 
not just prescription. We are going to deal with it more, and 
quite frankly, the more successful we are at controlling our 
borders, the more problem we are going to have with domestic 
produced drug questions, and that is why we have to get into 
prevention programs, treatment programs, of all type. But at 
the same time that means that there is going to be more 
pressure with our addiction problems in the United States, 
unless we more effectively communicate the dangers of getting, 
as we have heard multiple times, warning people about the 
interaction, unless the drug companies get more aggressive and 
unless the pharmacies rather than just say trust, trust, but 
verify and unless the doctors do trust but verify. This is not 
Marcus Welby M.D., and I know the younger people do not even 
know what I was talking about.
    Things have changed and we all need to change with it and 
helping make sure, hey look, we like over-simplifying 
government, we have to deal with laws that reach broadly, not 
an individual law for each case, so we have to balance that, 
but we are going to have to do that. I am tending to go on 
here.
    Any additional statements you want to get in, you can 
submit them for the record, we will probably have some 
additional questions.
    Once again, I thank Mr. Mica, and Mr. Norwood, thank 
everybody here for their patience as we went through this 
hearing.
    With that, the subcommittee stands adjourned.
    [Whereupon, at 1:30 p.m., the subcommittee was adjourned.]
    [The prepared statement of Hon. Dave Weldon and additional 
information submitted for the hearing record follows:]
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