<DOC>
[108th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:95555.wais]
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.
[The information referred to follows:]
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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:]
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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:]
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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:]
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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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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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<all>