[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
NASPER: WHY HAS THE NATIONAL ALL
SCHEDULES PRESCRIPTION ELECTRONIC
REPORTING ACT NOT BEEN IMPLEMENTED?
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
OCTOBER 24, 2007
__________
Serial No. 110-73
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan, Chairman
HENRY A. WAXMAN, California JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts Ranking Member
RICK BOUCHER, Virginia RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York J. DENNIS HASTERT, Illinois
FRANK PALLONE, Jr., New Jersey FRED UPTON, Michigan
BART GORDON, Tennessee CLIFF STEARNS, Florida
BOBBY L. RUSH, Illinois NATHAN DEAL, Georgia
ANNA G. ESHOO, California ED WHITFIELD, Kentucky
BART STUPAK, Michigan BARBARA CUBIN, Wyoming
ELIOT L. ENGEL, New York JOHN SHIMKUS, Illinois
ALBERT R. WYNN, Maryland HEATHER WILSON, New Mexico
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado CHARLES W. ``CHIP'' PICKERING,
Vice Chairman Mississippi
LOIS CAPPS, California VITO FOSSELLA, New York
MICHAEL F. DOYLE, Pennsylvania STEVE BUYER, Indiana
JANE HARMAN, California GEORGE RADANOVICH, California
TOM ALLEN, Maine JOSEPH R. PITTS, Pennsylvania
JAN SCHAKOWSKY, Illinois MARY BONO, California
HILDA L. SOLIS, California GREG WALDEN, Oregon
CHARLES A. GONZALEZ, Texas LEE TERRY, Nebraska
JAY INSLEE, Washington MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin MIKE ROGERS, Michigan
MIKE ROSS, Arkansas SUE WILKINS MYRICK, North Carolina
DARLENE HOOLEY, Oregon JOHN SULLIVAN, Oklahoma
ANTHONY D. WEINER, New York TIM MURPHY, Pennsylvania
JIM MATHESON, Utah MICHAEL C. BURGESS, Texas
G.K. BUTTERFIELD, North Carolina MARSHA BLACKBURN, Tennessee
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
______
Professional Staff
Dennis B. Fitzgibbons, Chief of Staff
Gregg A. Rothschild, Chief Counsel
Sharon E. Davis, Chief Clerk
David L. Cavicke, Minority Staff Director
(ii)
Subcommittee on Oversight and Investigations
BART STUPAK, Michigan, Chairman
DIANA DeGETTE, Colorado ED WHITFIELD, Kentucky
CHARLIE MELANCON, Louisiana Ranking Member
Vice Chairman GREG WALDEN, Oregon
HENRY A. WAXMAN, California MIKE FERGUSON, New Jersey
GENE GREEN, Texas TIM MURPHY, Pennsylvania
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee
JAY INSLEE, Washington JOE BARTON, Texas (ex officio)
JOHN D. DINGELL, Michigan (ex
officio)
C O N T E N T S
----------
Page
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 1
Hon. Ed Whitfield, a Representative in Congress from the State of
Kentucky, opening statement.................................... 3
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, prepared statement................................ 4
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 5
Hon. Frank Pallone Jr., a Representative in Congress from the
State of New Jersey, prepared statement........................ 6
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 7
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 8
Hon. Jan Schakowsky, a Representative in Congress from the State
of Illinois, opening statement................................. 10
Hon. Tim Murphy, a Representative in Congress from the State of
Pennsylvania, opening statement................................ 11
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 12
Prepared statement........................................... 13
Witnesses
Len Paulozzi, M.D., medical epidemiologist, Division of
Unintentional Injury Prevention, National Center for Injury
Prevention and Control, Centers for Disease Control and
Prevention, U.S. Department of Health and Human Services....... 14
Prepared statement........................................... 16
H. Westley Clark, M.D., Director, Center for Substance Abuse
Treatment, Substance Abuse and Mental Health Services
Administration, U.S. Department of Health and Human Services... 36
Prepared statement........................................... 38
Andrea M. Trescot, M.D., president, American Society of
Interventional Pain Physicians; director, Pain Fellowship...... 60
Prepared statement........................................... 62
Submitted Material
``What is a Pill Mill?'' CBS News, June 1, 2007.................. 97
Letter of October 23, 2007 from Charles M. Grudem, M.D., to
Andrea Trescot, M.D............................................ 98
Letter of Gayle B. Harrell, State representative, Florida House
of Representatives............................................. 101
Subcommitte exhibit binder....................................... 102
NASPER: WHY HAS THE NATIONAL ALL SCHEDULES PRESCRIPTION ELECTRONIC
REPORTING ACT NOT BEEN IMPLEMENTED?
----------
WEDNESDAY, OCTOBER 24, 2007
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:05 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Bart
Stupak (chairman) presiding.
Members present: Representatives DeGette, Green,
Schakowsky, Pallone, Whitfield, Murphy, and Burgess.
Staff present: Kristine Blackwood, Joanne Royce, Scott
Schloegel, Kyle Chapman, Alan Slobodin, and Karen Christian.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. The subcommittee will come to order. Today we
have a hearing on ``NASPER: Why Has the National All Schedules
Prescription Electronic Reporting Act Not Been Implemented?''
Each Member will be recognized for a 5-minute opening
statement. I will begin.
More than 2 years ago, with wide-spread support in both the
House and Senate, Congress passed the National All Schedules
Electronic Reporting Act, otherwise known as NASPER. NASPER
established a grant program at the Department of Health and
Human Services to foster the development of prescription drug
monitoring programs in every State. These drug monitoring
programs will provide a safe, comprehensive, and balanced
approach to stop the growing epidemic of prescription drug
abuse by detecting and preventing doctor shopping for addictive
drugs.
I was pleased to join with my good friends, Ed Whitfield,
ranking member of this subcommittee, full committee Chairman
John Dingell, Ranking Member Mr. Barton, as well as Congressman
Pallone, chairman of our Health Subcommittee, to work and have
Congress pass this comprehensive program to provide the tools
necessary to the physicians, pharmacists, and law enforcement
for fighting prescription drug abuse. In passing NASPER,
Congress recognized that prescription drug abuse cannot be
fought only by law enforcement. It is not enough to simply
prosecute pill mills and drug addicts to solve this complex
problem. Identifying the pill mills and prosecuting dealers
occurs after the pill pushers have been in business for months
or years, spreading the devastation to the addicts, their
families and communities.
Congress passed NASPER because we understand that, in
addition to putting drug dealers behind bars, we must ensure
that physicians, pharmacists, and public health officials have
the resources they need to identify and stop drug addiction
before it begins. NASPER would enhance that so physicians have
immediate access to patients' prescription drug history. NASPER
would give pharmacists the ability to thwart doctor shopping by
patients and drug dealers. NASPER would ensure that patients
are not being over-prescribed pain medicine or taking dangerous
combinations of prescription drugs. NASPER would ensure that
public health officials could review prescribing patterns,
educate, and warn physicians about medication risk. At the same
time, NASPER ensures that law enforcement will have access to
prescription drug data to support their investigations and
prosecutions.
In short, NASPER recognizes that prescription drug
addiction is both a law enforcement, medical, and a public
health problem. Congress granted HHS oversight of the NASPER
Program because we believe that the program fits best within
HHS's public health mission. NASPER calls upon the Secretary of
HHS to issue regulations with public input to ensure uniformity
among the States' prescription drug monitoring programs. If
drug monitoring programs receive real-time and uniform
electronic data, States can share critical drug data abuses
while effectively protecting patient privacy. The NASPER
Program will benefit from HHS expertise and experience in
addition to prevention, treatment, and medical privacy law,
health information, and e-prescribing technology. Moreover,
NASPER can be integrated with the prescription drug benefit
programs run by Medicaid and Medicare programs and help the
Food and Drug Administration to monitor the post-market effect
of prescription drugs.
This administration has failed to provide any funding to
implement the NASPER Program. Instead, the administration has
promoted and funded a drug addiction program at the Department
of Justice that was never authorized by Congress, a program
that emphasizes the law enforcement aspect of prescription drug
epidemic at the expense of public health concerns.
The purpose of today's hearing is to determine why the will
of Congress has been ignored. We will hear from three
distinguished witnesses this morning. First we will hear from
Dr. Leonard Paulozzi. Am I saying that correct, sir?
Dr. Paulozzi. It is Paulozzi.
Mr. Stupak. Paulozzi, from the Centers of Disease Control
and Prevention in Atlanta, and he is a nationally recognized
expert on prescription drug abuse trends. Dr. Paulozzi's
testimony will provide troubling evidence that the epidemic of
prescription drug abuse is getting worse, not better. Next, we
will hear from Dr. Westley Clark, the Director of the Center
for Substance Abuse Treatment at the Substance Abuse and Mental
Health Services Administration of HHS. Dr. Clark is an expert
in addiction treatment and prevention and leads the Agency's
effort to provide effective and accessible treatment to
Americans with addictive disorders. Our third witness will be
Dr. Andrea Trescot, the president of the American Society for
Interventional Pain Physicians, or ASIPP. In addition to her
leadership role with ASIPP, Dr. Trescot is a Director of Pain
Fellowship Program at the University of Florida. Dr. Trescot
will provide the physician's perspective on the importance of
implementing NASPER.
Let me advise members that we are setting up a meeting with
the Office of Management and Budget. This subcommittee
requested that OMB testify before us to gain a better
understanding of the administration funding goals.
Unfortunately, Director Nussle could not make it, but he will
be meeting with us at 3:30 p.m. Thursday. Let me be clear. This
subcommittee and this committee are committed to carrying out
the NASPER Program, and we hope the administration will join
us. I thank the witnesses for appearing today, and I look
forward to their testimony.
Next, let me yield to my friend and one of the advocates
of the NASPER Program, Mr. Whitfield from Kentucky, for an
opening statement, please.
OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF KENTUCKY
Mr. Whitfield. Chairman Stupak, thank you very much. I want
to thank you for convening this important hearing.
Back in 2005, many members of the Energy and Commerce
Committee co-sponsored legislation, the NASPER legislation,
which was passed by the House of Representatives under the
suspension calendar, and about 3 days later passed the U.S.
Senate, and then President Bush signed NASPER into law on
August 11, 2005. NASPER was the product of strong bipartisan
support. It was passed by the committee by voice vote after
hearing testimony about the epidemic of prescription drug abuse
in this country. The members of this committee and the House
and Senate felt compelled to create a Federal prescription drug
monitoring program to reinforce the State programs and to
ensure that these programs were interoperable, that information
could be shared, that the NASPER law also provided a basic
guideline and had mandates in it so that every program had to
meet certain specifications. It allows physicians to obtain
information about their patient so that they can identify and
treat a possible addiction. It also allows law enforcement to
access prescribing information so that they can build
investigations against doctors and patients who abuse the
healthcare system by improperly prescribing or obtaining
prescription drugs.
Yet almost 2 years after NASPER was signed into law by the
President, not a single dollar has been requested by the
administration, by OMB, and I am not sure, Dr. Clark, that even
HHS has asked for any dollars for this program when you
compiled your budget requests and sent them to OMB. As Chairman
Stupak said, we have talked to OMB, we invited OMB to come and
testify, and they said they would like to meet with us
privately on this issue. But I would like to stress what
Chairman Stupak said. The only program in existence today is a
non-authorized program that the Appropriations Committee
decided that they would fund without any hearings, without any
checks and balance on the system. They simply provided the
money, and the first year after NASPER was signed, we all sat
in a room, appropriators and Energy and Commerce people, and
Chairman Barton was very emphatic in that meeting that NASPER
was going to be funded. We agreed to fund NASPER to the tune of
$5 million, and the Department of Justice system was funded for
$5 million, but due to the continuing resolution, funding for
NASPER was never appropriated. And we asked Chairman Dingell to
get involved in this issue because it does go to the
jurisdiction of this committee. We have jurisdiction over this
issue, but more important than that, more important than
jurisdiction, is which program is the best program?
The DOJ program is focused on law enforcement. NASPER is
focused on providing information for physicians so that they
can best treat their patients, who may be suffering from drug
addiction, and we know that drug addiction is a serious problem
around the country. And I know that Dr. Paulozzi will talk
about that in his testimony. And I also noted that, Dr. Clark,
we are glad you are here today, but I noticed in your testimony
you don't mention anything about NASPER. You are talking about
the DOJ program, but the DOJ program was not authorized by
anyone, and appropriators don't have jurisdiction over the
program. We have jurisdiction.
And so I look forward to the testimony today, because this
is a program passed by Congress, signed by the President, and
someone has the responsibility and obligation to fund this
program, not because this committee passed it, but because it
is the best program, the one most likely to succeed. So, with
that, Mr. Chairman, I will yield back the balance of my time.
Mr. Stupak. I thank the gentleman. I ask for unanimous
consent to enter Chairman Dingell's statement in the record,
and that statement of all members will be entered in the
record, whether they appear or if they just provide a
statement.
[The prepared statements of Messrs. Dingell, Barton, and
Pallone follow:]
Prepared Statement of Hon. John D. Dingell, a Representative in
Congress from the State of Michigan
Mr. Chairman, thank you for holding this hearing on
implementation of the National All Schedules Prescription
Electronic Reporting Act (NASPER).
The NASPER legislation was passed by the 109th Congress
and signed into law by the President in 2005. Although the
NASPER Program was enacted 2 years ago, this administration has
done virtually nothing to implement it and has failed to
include any money for the program in its annual budgets. It is
vitally important to our system of government that when
Congress establishes national policy by passing laws, those
laws are not simply ignored by the executive branch. Today, I
hope we learn more about the benefits of this program as well
as the reason for the administration's failure to seek funding
for it.
In order to solve the problem of prescription drug abuse,
we need a multi-pronged approach. We cannot solve the complex
problems associated with abuse and addiction with criminal
enforcement alone. We need to enlist physicians, pharmacists,
and other healthcare professionals in the fight. A robust,
nationwide system of prescription drug monitoring programs will
help medical professionals prescribe responsibly. Strong
monitoring systems can allow physicians to promptly identify
patients at risk for addiction and get them into treatment, and
avoid patients who are ``doctor shopping'' to feed their own
addiction or to sell their drugs to other addicts.
NASPER would provide a strong monitoring tool to help not
only law enforcement but also the medical community stop the
``pill-pushing'' and ``doctor shopping'' that has devastated so
many of our communities over the last decade. Especially in
rural areas, where isolated physicians and pharmacies can
easily be manipulated by addicts who travel from community to
community to get their fix for illegal pharmaceuticals, NASPER
would ensure that these healthcare providers know what drugs
their patients have recently obtained or have tried to obtain
in other communities including those across State lines.
As you know, Mr. Chairman, our State of Michigan has a
strong prescription drug-monitoring program. Ninety-five
percent of the requests Michigan's program receives are from
doctors and pharmacists seeking to ensure that patients are
getting the medicine they need for genuine medical purposes,
not medicine that will be used for illicit purposes. I am
interested in hearing from our witnesses how Michigan's program
compares with others around the Nation and how NASPER could
enhance these programs.
I commend Ranking Member Whitfield for his leadership on
this issue, and I thank our witnesses for their testimony
today.
----------
Prepared Statement of Hon. Joe Barton, a Representative in Congress
from the State of Texas
Thank you, Chairman Stupak and Ranking Member Whitfield,
for holding this hearing on the status of the National All
Schedules Prescription Electronic Reporting Act.
NASPER is the result of broad, bipartisan and bicameral
cooperation of the kind that we don't see much anymore. It
passed this committee over 2 years ago by voice vote. The House
passed it as a suspension bill, and the Senate passed it by
unanimous consent. The President signed NASPER into law on
August 11, 2005.
NASPER was so successful as legislation because its
purpose was so transparent and simple. The law created grants
to help fund state prescription drug monitoring programs. The
idea, as I noted 2 years ago when we passed NASPER, is that
States be able to work with each other to stop the abuse of
prescription drugs. NASPER starts the States on the road to
cooperation by making certain that they each collect the same
information. So instead of 50 separate monitoring programs with
50 different data sets that don't jibe, States collect the same
data and then share it. Real interoperability means we can
detect illicit prescription-drug operations when the drug
dealers shift across state lines. Without NASPER,
unfortunately, drug abusers and their dealers can still
prescription-shop in some States because some information isn't
being shared. That's a problem, and we're here today to start
fixing it.
The Energy and Commerce Committee was also concerned about
protecting the privacy of Americans whose information is held
in the prescription drug databases. NASPER establishes strict
criteria governing the use and disclosure of the information
that states must meet in order to receive funding. Without
NASPER, there are no minimum standards to protect the personal
information held in prescription drug monitoring program
databases.
Despite these positive features, NASPER has not yet been
funded. Although the President signed the bill, funding for
this important program was not included in the President's
budget. On January 10, 2006, several of us on the committee--
including Chairman Dingell, Mr. Whitfield, Mr. Stupak, Mr.
Deal, and Mr. Pallone--wrote to then-director of the Office of
Management and Budget Joshua Bolton, requesting the inclusion
of $15 million in the administration's fiscal year 2007 budget
for NASPER. To get NASPER launched, there has to be a budget
request. At the February 6, 2007 full committee hearing on the
HHS fiscal year 2008 budget, HHS Secretary Michael Leavitt
testified that HHS supported the program, but that OMB decided
not to include a budget request for it. I understand that we
have not even received a reply to the January 10, 2006 letter.
We had hoped to have a witness from the Office of
Management and Budget here today to explain OMB's reluctance.
Instead, I understand that OMB Director Jim Nussle has agreed
to meet with Mr. Whitfield and other members of this
subcommittee in the near future to discuss the status of
NASPER's funding. I hope that Director Nussle can finally
answer the question we put to two of his predecessors: Why
hasn't the administration included a request to fund NASPER in
its budgets? The problem of prescription drug abuse doesn't
seem to be curing itself, and it isn't as if the issue is
either partisan or even mildly controversial. We are here today
to find out why nothing has happened.
I am committed to ensuring that NASPER is funded. Last
year, I raised a point of order to the appropriations bill for
the Commerce, Justice, and State Departments because funding
was included in that bill for an unauthorized prescription drug
monitoring program at the Justice Department while no
appropriations were provided for NASPER. I trust now that they
are in the majority, Committee Chairman Dingell and
Subcommittee Chairman Stupak will continue to make this
committee's concerns about the lack of funding for NASPER known
to our colleagues here in the House and to the Administration.
I suspect I can count on it, in fact.
Thank you, again, Chairman Stupak and Ranking Member
Whitfield. I yield back the balance of my time.
---------- I1
1/
Prepared Statement of Hon. Frank Pallone, Jr., a Representative in
Congress from the State of New Jersey
Thank you, Mr. Chairman, for holding this hearing and
allowing me to participate. I am pleased to be here today to
discuss the importance of prescription drug monitoring. The
bipartisan legislation we are reviewing today was signed into
law by President Bush in 2005, But today, more than 2 years
later, it has still not been funded. As the only program
authorized in statute to assist states in combating
prescription drug abuse, it is crucial that we work to ensure
the Act receives the funding needed for implementation.
At the time this legislation was passed, members on both
sides of the aisle agreed that rampant prescription drug misuse
and abuse was a growing problem. And now, 2 years later, it is
still a growing problem. In fact, the diversion of prescription
drugs is one of the fastest growing areas of drug abuse in our
Nation today. It is a problem that is blind to geographic
regions, blind to age, and blind to income-levels. And
according to the data, it affects 9 million Americans.
In my home State of New Jersey alone, 4.1 percent of our
residents have abused prescription drugs in the past year. The
per capita retail distribution of the pain medication oxycodone
increased 181 percent between 2000 and 2005. For hydrocodone,
another pain medication, it increased 66 percent during that
same timeframe.
Some States have already begun developing the means to stop
this escalating trend, and Congress agreed back in 2005 that
the NASPER Act was the best way to aid States in their efforts
to ensure that prescription drugs are only being used for
medical purposes, in the correct way, and that they are not
getting into the hands of people who would abuse them.
The solution presented through NASPER is to create a better
monitoring and tracking system for prescription drugs. And
studies have shown these types of programs to be very
effective. The five States with the lowest number of oxycodone,
specifically OxyContin prescriptions per capita, have long-
standing prescription monitoring programs and report no
significant prescription drug diversion problems. While at the
same time, the five states with the highest number of OxyContin
prescriptions per capita do not have prescription monitoring
programs and have reported severe abuse problems.
This data strengthens the argument that health care
practitioners and pharmacists desperately need electronic
monitoring systems to ensure that they are prescribing and
dispensing Schedule II, III, and IV Controlled Substances that
are medically necessary. And NASPER assists them in this area.
As passed in 2005, NASPER would provide grants to help
States develop or expand a prescription drug-monitoring program
that has the ability to communicate with monitoring programs in
other States. Any Controlled Substance II, III, or IV that is
prescribed would be electronically reported by the physician or
pharmacist to the State's primary monitoring authority. Upon
certified request, physicians and law enforcement can access
the information in these databases, in an effort to prevent
prescription drug addiction and to crack down on bad actors who
are contributing to the problem.
Without these interconnected databanks, practitioners and
pharmacists have no way of knowing with any certainty whether a
particular patient has received the same drug or another
incompatible controlled substance already from another
practitioner.
This is particularly troubling in light of the fact that
physicians are increasingly more hesitant to prescribe these
medications out of fear that they will be the ones to take the
fall if a patient is in fact ``doctor shopping'' and abusing
these substances. More and more patients have to suffer from
intense pain because doctors are overly cautious in prescribing
the medications they need. A program like the one we are
discussing today would protect the innocent provide them with
the information they need to make the correct decisions for
their patients.
The NASPER bill passed Congress and was signed into law in
August 2005. Thanks to its passage, I firmly believe that we
will move one step closer in providing a strong and effective
approach to addressing prescription drug abuse and crime. But
our fight is not over, just because the bill has passed. Now we
need to get the program funded so we can provide the necessary
money to States.
Because of the strict timetable set forth in NASPER, it is
vital that funding be included in fiscal year 2008 to ensure
that HHS is able to promulgate regulations and seek public
input, thereby allowing grants to be awarded this year.
My colleague from Kentucky, Ed Whitfield, and I are busy
working towards achieving that goal. We have sent a letter to
appropriators requesting $15 million in funding for NASPER in
fiscal year 2008. I have the letter here, Mr. Chairman, and
would like to submit it for the record. We have also been
speaking with members of the appropriations committee urging
them to fulfill our request.
And I would like to thank you again, Mr. Chairman, for
having this very important hearing today. I am hopeful that we
will be able to get this program funded this year. I would also
like to thank all the witnesses for joining us and I look
forward to your testimony.
----------
Mr. Stupak.With that, next I would move to Mr. Green for
opening statement, please.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman, for ordering this
hearing on prescription drug monitoring programs and the NASPER
Program, which Congress enacted in 2005. High-ranking member
Mr. Whitfield was the author of the National All Schedules
Prescription Electronic Reporting Act, and I was proud to be a
co-sponsor and support it when it went through both our
committee and both the 108 and 109th Congress. The need for
NASPER is clear to us, being on both the law enforcement level
and a drug safety level. With State prescription drug
monitoring programs sporadic and not interoperable, it was
relatively easy for individuals who abuse prescription drugs to
doctor shop for controlled substances or obtain the
prescription drugs illegally with little detection from
physicians or law enforcement.
The Texas prescription drug monitoring program, called the
Texas Prescription Program, was established more than 25 years
ago, in 1981. Each year the Texas Prescription Program collects
3.3 million prescriptions and monitors Schedule II prescription
drugs. During the first year of the Texas Prescription Drug
enactment, the number of Schedule II prescriptions filled in
the State fell by 52 percent. The program helped the State
crack down on pill mills and forged prescriptions, but it is
clearly a law enforcement program and housed at the Texas
Department of Public Safety. Without question, prescription
drug monitoring programs offer significant benefits for law
enforcement. They should go hand in hand with the drug safety
and public health benefits. It is disturbing that the
administration doesn't recognize these dual needs and implement
the NASPER Program.
Mr. Whitfield, this committee purposely housed NASPER with
the Department of HHS to strike the appropriate balance between
law enforcement activities and public health safeguards. In
fact, the criteria for grant awards ensured a certain level of
interoperability, timely reporting by pharmacies, and
assurances for patients of privacy. By giving physicians access
to the data compiled by prescription drug monitoring programs,
NASPER would also help physicians coordinate care and reduce
the number of contraindicated drugs prescribed to patients. The
administration's refusal to implement this program suggests it
is only interested in law enforcement aspects of prescription
drug monitoring programs.
Secretary Leavitt supported this conclusion when he
appeared before this committee earlier this year and cited
OMB's decision to review these programs as law enforcement
tools, while the administration's synthetic drug control
strategy and drug monitoring program is at the Department of
Justice. The problem is, neither the administration's synthetic
drug control strategy nor the DOJ grant program ever has been
authorized by Congress. My State received the welcomed grant
funding through the DOJ programs, but the DOJ programs only
provide half a loaf. Within the DOJ program, there is no real
strategy for interoperability, which is critical if we want to
stop folks from hopping across State lines to obtain
prescription drugs illegally and escape detections from their
home State monitoring programs. The DOJ programs also have none
of the safeguards for patient privacy and pay little to no
attention to public health ramifications.
Like my colleagues, I wish OMB Director Nussle would have
appeared before us today and explained the administration's
rationale for failing to implement NASPER. However, I am
pleased that he has agreed to meet with our Chair and ranking
member to discuss the important issue. I hope that Mr. Nussle,
as a former member of this chamber, will be able to understand
the frustrations we feel when the administrations ignore
Congressional intent. And I would like to thank the Chair and
the ranking member for holding this hearing and needed
oversight over the administration's inaction on this issue and
shed light on the administration's missed opportunity to
address the problem of prescription drug abuse in an effective
manner. And again, I am glad our witnesses are here.
Mr. Chairman, I yield back my time.
Mr. Stupak. Thank you, Mr. Green. Mr. Burgess, for an
opening statement, please.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thank you, Mr. Chairman, and I appreciate very
much you holding this hearing today. Back in my home State of
Texas, in the city of Dallas, the Dallas Morning News ran a
series of several articles, 2003, 2004, 2005, on a physician
who ran a pill mill. And it seems that everyone knew about the
pill mill. He didn't make appointments, but he saw a lot of
patients, and the patients were seen, I guess you would call it
kind of a modified wave method of making appointments. The
patients would sleep in the parking lot so they would be the
first in line to get in the door the next day, and in fact
sometimes the clinic had to hire off-duty police officers to
kind of keep order in the parking lot before the clinic opened.
The doctor would see 200 patients a day. They were mostly
Medicaid and Medicare beneficiaries. In fact, this office was
the source for the largest single source of Diazepam
prescriptions for Medicaid prescriptions in the State of Texas.
Now, at least 11 of his patients died, and they died of drug
overdoses or drug complications, and after a very long
investigation, culminating just a few weeks ago, this doctor
received probation. I think, had this program, had NASPER been
up and running and functioning, I think he certainly could have
been contained much earlier, and I think some patients and
their families could have foregone some needless suffering, and
perhaps we could have even avoided loss of life.
Now, when NASPER was signed into law, August 11, 2005, it
was the only congressionally authorized program to assist State
prescription drug monitoring programs. The previous program
established by the Department of Justice was created with a
lack of adequate Congressional oversight and appropriate
administration by the Justice Department. Both parties agreed
that such a program should have strict guidelines and that
Health and Human Services is better suited to administer such a
program than the Department of Justice. So NASPER must be
funded, especially to guard against scenarios such as this that
has been well documented in my papers back home.
Well, Chairman Stupak, I thank you and ranking member
Whitfield for holding the appropriators accountable, and I join
in asking them to make the Appropriations Committee aware and
to fund this program.
And NASPER could allow doctors to find out what medications
a patient is currently taking and what he or she has taken in
the past. Without a database in place for doctors to track
patient history, doctors have no way of knowing who is really
in pain and who is looking to abuse the system, and I speak of
this with some authority because I was a practicing physician
back in Texas for 25 years, and I certainly know. I got caught
in similar situations. I do have some questions. I have some
questions about how this is affected by our current HIPAA laws,
and then, going further, how is the law that we recently
passed, the Genetic Information Non-Discrimination Act, how is
that going to affect the sharing of information, because that
bill was fairly broadly constructed and I think may have more
of an effect on this that will curtail the sharing of data. Now
a database is extremely powerful, extremely powerful in helping
to manage a patient's care and helping to provide information
to caregivers about a patient's status.
We had a situation in Dallas right after Hurricane Katrina
landed in New Orleans 2 years ago. A lot of folks were taken
from the Superdome in Louisiana and delivered to the parking
lot outside Reunion Arena in Dallas. Many of these people were
patients who were on multiple medications. Many of them had
been without their medications for several days, and some were
just a few steps away from getting into serious trouble with
their underlying illness. One of the chain pharmacies set up a
mobile unit right outside Reunion Arena, and doctors were able
to quickly access the database, get information about the
patients. Obviously Charity Hospital didn't have electronic
medical records up online, but this data was available to the
doctors who were receiving those patients and triaging those
patients in the parking lot of Reunion Arena, and within a very
short period of time were able to accommodate those patients'
needs. And I think out of the many, many thousands of people
who were transferred from New Orleans to Dallas, only a few
required hospitalization, because they got timely treatment and
timely recognition on the night of their arrival. So it just
underscores how powerful a database can be if used
appropriately.
Mr. Whitfield alluded to how important it is to have
interoperability of databases, and I certainly think that is
key if we are going to have two side-by-side systems. Clearly
they need to be able to communicate with each other in
efficient fashion. But realistically if we could have a single
system that worked and was funded, I think that is the
preferable route to go.
With that, Mr. Chairman, I will yield back the balance of
my time.
Mr. Stupak. Thank you. Next opening statement, Ms.
Schakowsky, please.
OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Ms. Schakowsky. Thank you, Mr. Chairman. This is an
important hearing for a couple of reasons. First, we all know
that prescription drug abuse is rising and that accidental
deaths from overdose have increased dramatically. But in
addition, we know that over 2 years ago this Congress passed,
and the President signed into law, aimed at fighting this
growing problem. And yet to date, as people have said, but I
think it bears repeating, no funds have been included in the
President's budget for the implementation of this bipartisan
bill, the NASPER.
Without a doubt, there is a need for a tool to reduce
prescription drug abuse. For many of our communities, this is
an ever-growing problem that has resulted in the death of too
many friends and neighbors and family members. According to
this committee's records, when HHS Secretary Michael Leavitt
testified before this committee on the President's 2008 budget,
he stated that the Department supported the program and that it
was a program that he would gladly administer. Yet, when
pressed further, he deferred to the OMB, stating that it was up
to them to make a final decision. And meanwhile, over the past
several years, the Department of Justice has made annual grants
to a number of States for the purpose of establishing or
strengthening a prescription drug monitoring program. These
grants have been supported both through Congressional earmarks
and the President's budget requests, so the question I look
forward to answering today is why NASPER has yet to be
implemented or funded despite administration support for the
prescription drug monitoring. Additionally, I look forward to
hearing from our witnesses regarding what appears to be this
administration's preference to house the prescription drug
tracking program at a law enforcement agency, as opposed to the
Department of Health and Human Services. I have concerns about
what this means for patient privacy and preserving the
relationship between patients and their physicians.
It is also important that we examine the disadvantages of
relying on the DOJ grant program, a competitive grant program
which has yet to reach all States. Furthermore, State PDMPs
have remained largely incompatible. If our best interests lay
in exposing bad actors within the prescription drug arena, our
system must be interoperable and attainable for all States. So
I look forward to getting some answers from our witnesses, and
I thank them all for being here today, and I yield back.
Mr. Stupak. I thank the gentle lady. Mr. Pallone was here,
and he had to step out, but unfortunately Mr. Pallone is not a
member of the subcommittee, so he may not be allowed to make an
opening statement but may be back to ask questions. But it
should be noted, as I noted in my opening statement, it was Mr.
Pallone, as ranking member of the Health Subcommittee, who
helped push this legislation through and critical in getting it
passed and signed into law. We appreciate his continued
interest, and hopefully he will be able to make it back in time
for questions. With that, Mr. Murphy, for an opening statement,
member of the subcommittee.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF PENNSYLVANIA
Mr. Murphy. Thank you, Mr. Chairman, and thank you for
holding this important hearing. In particular because we are
all very concerned about the abuse of prescription drugs, it
should be noted that high school students in the United States
and college students are declining in their abuse of illicit
drugs for consecutive years, but there is an increasing level
of the abuse of prescription drugs among youth and adults. And
it is cause for concern, and it is an area that we need to
closely monitor. And what we are considering today is a
mechanism by which we can do this.
I would like to quote briefly from an article that appeared
in the Pittsburgh Post Gazette earlier this year, in March,
where in reference to an interview with a Dr. Neil Capretto of
the Gateway Rehabilitation Center in Pittsburgh, he said,
``There has been a growing non-medical addictive use of
prescription drugs, particularly opioid drugs like Oxycontin,
codeine, morphine, Percocet, Vicodin, and Dilaudid. Opiates
possess more properties characteristic of opioid narcotics like
heroin and morphine but are not derived from opium poppy.'' He
went on to say, ``The good news is, we are treating pain better
than we did 10 years ago. The bad news is, there are more
people abusing and misusing prescription drugs. Unfortunately,
from our end, I am really afraid it is going to get worse
before it gets better.''
As of 2003, 6.3 million Americans used prescription drugs
for non-medical purposes. In 2002 almost 30 million people had
used prescription pain relievers for non-medical purposes.
Prescription medications are now involved in close to 30
percent of drug-related emergency room visits. The most recent
monitoring, the Future Report from University of Michigan,
found that 5.5 percent of all high school seniors abuse
Oxycontin. Oxycontin abuse has increased 26 percent since 2002
among 8th- and 9th- and 12th-graders. The abuse of prescription
drugs cuts across gender, race, and virtually all groups.
As we look at programs like NASPER, it is disappointing
that it has not been funded, and that is why we are here today.
The Appropriations Committee continues to fund a program out of
DOJ that focuses solely on enforcement. Although we are pleased
that DOJ has this program, and I don't necessarily have a
problem with the DOJ program, but we have rules in place for a
reason. Why should we fund an unauthorized program when we have
an authorized program that accomplishes the same mission? With
that said, we do agree on the mission, to prevent prescription
drug abuse. In my many years of practice as a psychologist, I
saw the wretched examples of drug abuse first-hand. And as we
look at this, my questions will be, how can we make these
programs work together? How can we make them be effective and
efficient, not redundant or exclusive? How can we gather and
share data and databases so we can work with law enforcement
officials, we can work with drug treatment programs, and we
will work with effective funding here in Congress?
I don't believe there is anybody here who does not consider
it a high mission of this Congress to make sure we do all we
can to reduce prescription drug abuse and all drug abuse, for
that matter. Because people understand how they can doctor
shop, because databases are not clear, it stands as a barrier
to enforcement. It stands as a barrier to treatment, and
unfortunately it is the system that the drug abuser has figured
out how to get around for now. We have to close those doors if
we are going to help people. And again, reflecting on the
statistics I read earlier, about 8th- and 9th- and 12th-
graders, it would be a real tragedy if we did not work to make
this program work, to make this program and the Department of
Justice program find a way of working together so that our goal
of Justice and our goals in Congress of reducing and
eliminating prescription drug abuse are met.
I look forward to hearing the testimony of this hearing of
how we can reach those goals, and I yield back my time, Mr.
Chairman.
Mr. Stupak. Thank you. Ms. DeGette, for an opening
statement, please.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you, Mr. Chairman. Mr. Chairman, I will
submit my full statement for the record, but I just want to say
that a couple of months ago I read one of those articles that
really opens your eyes in the New York Times Magazine--about
patients who truly have chronic pain that affects their whole
ability to conduct their lives. And these patients are really
stuck in a whipsaw, because on the one hand they are trying to
get medications that will help solve their pain, and there are
many legitimate doctors now who say that patients like these
really do need very high doses of pain medication. But these
patients are caught because they are identified as abusers of
these medications. And, at the same time then, you have people
who really are abusers of these medications, and they are
illegally obtaining these drugs. I think that NASPER would
really help to bring some sense to this situation and allow the
legitimate patients to get the drugs that they need, so that
they can get pain relief while at the same time giving law
enforcement the tools to track and identify both the abusers of
these drugs and the physicians who are participating in some of
the abuses. So I think it is a real shame on behalf of the
patient and on behalf of law enforcement that we haven't funded
NASPER, and I know that talks are continuing. I would hope that
the administration would really put some funding behind this
very important program.
With that, Mr. Chairman, I will yield back.
[The prepared statement of Ms. DeGette follows:]
Prepared Statement of Hon. Diana DeGette, a Representative in Congress
from the State of Colorado
Mr. Chairman, let me begin by thanking you for holding this
hearing on the National All Schedules Prescription Electronic
Reporting Act, a vital tool for ensuring public health and
safety.
Sadly, drug abuse has become an all-too-familiar issue,
whether it be illicit drugs or drugs prescribed for pain
relief. Chronic pain, for example, is a legitimate concern with
legitimate treatment options, yet prescription pain killers are
often abused. We need a way to allow patients access to such
drugs when they are appropriate, while at the same time
adequately controlling access and identifying patients who are
at risk of addiction or are so-called ``doctor shoppers.'' We
passed NASPER and signed it into law in 2005 for exactly these
reasons, yet nothing has come of the program to date.
NASPER would give law enforcement personnel access to drug
monitoring data that relates to illegal prescribing,
dispensing, or procurement of controlled substances, while also
providing reliable data to doctors in the form of
``prescription histories'' for their patients. Prescription
histories not only help to identify doctor shoppers, but also
help doctors identify patients who might at risk of addiction
and would therefore be better-suited to an alternative, less
addictive drug. Just as importantly, it would enable doctors
and patients to avoid potentially deadly drug interactions that
occur when patients see multiple doctors for different
conditions but neglect to inform the doctor of other
prescriptions they may be taking.
NASPER does all this while providing privacy safeguards for
patient protection and without placing pressure on doctors to
avoid prescribing medicine that is legitimately needed.
NASPER has the potential to be of immense value, yet
because the Administration has failed to provide funding for
it, it has not been able to help a soul.
In fact, the administration has instead funded a different,
unauthorized prescription drug monitoring program through the
Department of Justice. This does not make much sense to me,
especially given that the DOJ program lacks some of NASPER's
key components.
For example, the DOJ program lacks interoperability
requirements that would allow States to share data--a key
problem that we are seeing repeatedly with current Health
Information Technology initiatives. NASPER, on the other hand,
includes such interoperability provisions.
Mr. Chairman, I would like to know why the administration
is yet again dismissing Congress' authority--by not only
failing to fund NASPER, but by instead funding an unauthorized
program.
I yield back the balance of my time.
----------
Mr. Stupak. Thank you. That concludes the opening
statements by members of the subcommittee.
We have our first panel before us. On our first panel we
have Dr. Westley Clark, Director of the Center of Substance
Abuse Treatment within the Department of Health and Human
Services, Substance Abuse and Mental Health Services
Administration, SAMHSA, as we call it, and Dr. Len Paulozzi, a
medical epidemiologist at the Centers for Disease Control and
Prevention. It is the policy of this subcommittee to take all
testimony under oath. Please be advised that witnesses, under
the rules of the House, have the right to be advised by counsel
during testimony. Do either of you gentlemen wish to be advised
by counsel during your testimony?
Dr. Paulozzi. No.
Dr. Clark. No.
Mr. Stupak. Both indicate they do not. Therefore I will
ask, since it is tradition to take testimony under oath, please
rise, and raise your right hand to take the oath.
[Witnesses sworn]
Mr. Stupak. Let the record reflect both witnesses replied
in the affirmative. You are now under oath. We will begin with
your opening statements. Dr. Paulozzi, would you like to go
first for 5 minutes for an opening statement, please, and thank
you again for appearing.
TESTIMONY OF LEN PAULOZZI, M.D., MEDICAL EPIDEMIOLOGIST,
DIVISION OF UNINTENTIONAL INJURY PREVENTION, NATIONAL CENTER
FOR INJURY PREVENTION AND CONTROL, CENTERS FOR DISEASE CONTROL
AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Paulozzi. Good morning, Chairman Stupak, Ranking Member
Whitfield, and distinguished members of the subcommittee. My
name is Dr. Leonard Paulozzi, and I am a medical epidemiologist
at the Centers for Disease Control and Prevention. I am here on
behalf of the CDC Director, Dr. Julie Gerberding. My remarks
will focus on drug poisoning involving prescription drugs in
the United States as a public health problem. Can I have the
second slide?
[Slide]
By way of background, this figure shows the leading causes
of unintentional or, if you will, accidental injury death in
the United States in 2004. The green bar is motor vehicle
deaths. The yellow bar in the center is poisoning, which ranks
as the second-leading cause of unintentional injury death, with
approximately 20,000 deaths from this cause in the year 2004,
of which 95 percent of these poisoning deaths are drug
overdoses. Next slide.
[Slide]
The problem here is this upward trending line. This is drug
poisoning death rates in the United States from 1970 through
2004. You can appreciate the trend line and the dramatic
increase in the 1990's and the first years of this decade. We
can explain some of the earlier blips with black-tar heroin or
crack cocaine, but the problem was explaining what happened in
the later years of the 1990's. Next slide.
[Slide]
We did a study which looked at the death certificates to
identify the drugs that were listed there as causing these
deaths. We broke it down into three types, heroin in white,
cocaine in yellow, and the red line at the top, pointed by my
marker, is the opioid analgesic category. You can see it is
going up dramatically. It outnumbers either heroin or cocaine
by the year 2004. And this opioid analgesic category, of
course, is the narcotic painkillers like Oxycontin and Vicodin
that you have heard so much about. Next slide, please.
[Slide]
Again, this is the drug mortality death rate line that you
saw before. I have paired it with opioid sales, shown here in
green. These are sales per capita, shown from 1997 on. From
1997 to 2004, the opioid sales increased six-fold, and the line
closely tracks the death rate in drug poisoning. The other
thing to note is that, 2005 and 2006 sales continued to go up,
so we expect further increases in the drug poisoning death rate
in 2005 and 2006. Indeed, preliminary information from 2005
suggests that the death rate did rise in 2005. Next slide,
please.
[Slide]
This shows the drug poisoning death rates in the United
States. The dark States are those with the top third of death
rates. I would like to point out that we have traditionally
high rates in the Southwest. Louisiana, Maine, are also high,
but we have a band of States, Appalachian States, from
Tennessee to Pennsylvania, with some of the highest rates in
the country. And as late as 1990, these same Appalachian States
had some of the lowest rates in the country. So this has really
affected rural States more than urban States in this particular
prescription drug problem. Next slide.
[Slide]
Well, death certificates don't tell you circumstances of
the death. So how do you know whether these are accidents of
people taking too many pills, or are these abuse? We think that
these are primarily related to misuse and abuse of prescription
drugs, for three reasons. People dying of the prescription
drugs are largely middle-aged males: the same groups who died
of heroin and cocaine in earlier years. Surveys from SAMHSA
have annually shown steady increases in prescription drug
misuse, non-medical use rates in the United States. And lastly,
studies done by medical examiners have found that the
decendents from prescription drug deaths typically or commonly
will have a history of substance abuse. Next slide.
[Slide]
How can the problem be addressed? Obviously this is a
multi-factorial, complicated problem, and solving it depends
upon input from multiple Federal and State agencies. CDC will
continue to respond to this problem, as it has, through
surveillance activities, epidemiological work, and through
evaluation of potential interventions. In the next year, CDC
will focus on a study of prescription drug deaths and poisoning
victims. We will also start an evaluation of prescription drug
monitoring programs, and we are working with the Association of
State and Territorial Health Officials to look at State-
specific policy responses to this problem.
Thank you for the opportunity to appear here today to make
you aware of the serious health consequences of this growing
misuse of prescription drugs in the United States, and I will
be happy to answer any questions you may have.
[The prepared statement of Dr. Paulozzi follows:]
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Mr. Stupak. Thank you, Dr. Paulozzi. Dr. Clark, your
opening statement, please, sir.
TESTIMONY OF H. WESTLEY CLARK, M.D., DIRECTOR, CENTER FOR
SUBSTANCE ABUSE TREATMENT, SUBSTANCE ABUSE AND MENTAL HEALTH
SERVICES ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. Clark. Mr. Chairman, members of the subcommittee, my
name is Dr. H. Westley Clark, and I am the Director of the
Centers for Substance Abuse Treatment, within the Substance
Abuse and Mental Health Services Administration, an agency of
the U.S. Department of Health and Human Services. I am
testifying on behalf of our Administrator, Terry Cline, Ph.D.,
who was not able to be here. I am a board certified
psychiatrist with added qualification in addiction and
psychiatry.
According to SAMHSA's National Survey on Drug Use and
Health, combined data from the reports from 2002 to 2006
indicate that an average of 4.7 percent of persons age 12 and
older, an estimated 12.6 million people, used prescription pain
relievers non-medically in the 12 months prior to the survey.
2006, 2.1 percent of persons age 12 and older used a
prescription pain reliever non-medically in the month prior to
the survey. Among persons 12 and older, 2.2 million initiated
non-medical use of prescription pain relievers within the past
year, and that is about the same as the estimated number of
initiates for marijuana.
Where do people obtain their drugs? The 2006 National
Survey on Drug Use and Health also revealed where the people
were obtaining their prescription drugs. Nearly 56 percent of
the patients who had non-medical use of prescription pain
relievers obtained the drugs free of charge from a friend or a
relative, 19.1 percent from a single doctor; 14.8 percent
bought or took them from a relative or a friend; 3.9 percent
bought from a drug dealer or other stranger; 1.6 percent got
them from more than one doctor; less than 1 percent reported
getting them from the Internet; and 4.9 percent got them from
other sources, including a fake prescription, or stole them
from a doctor's office, clinic, or hospital pharmacy. As a
result, it is clear that what we need is a coordinated
response.
The emerging challenge of prescription drug abuse and
misuse is a complex issue that requires epidemiologic
surveillance, distribution chain integrity, intervention, more
research by both the private and the public sectors. We also
need to be concerned about the issue of the appropriate use of
prescription drugs. We know that there are some 75 million
people who are suffering from severe pain. Some 50 million
people suffer from chronic pain, and some 25 million people
suffer from acute pain. So the Federal Government needs to work
with medical partners, public health administrators, State
legislatures, international organizations, are all needed to
collaborate and cooperate through educational outreach and
other strategies targeted to a wide swath of distinct
populations, including physicians, pharmacists, patients, both
intended and inadvertent, educators, parents, high school and
college students, high-risk adults, the elderly, and many
others. Outreach to physicians and their patients and
pharmacists needs to be complemented by education, screening,
intervention, and treatment for those misusing or abusing
prescription drugs.
Beginning fiscal year of 2002, Congress appropriated
funding to the Department of Justice to support prescription
drug monitoring programs. Since the inception of the Department
of Justice program, called the Harold Rogers Prescription Drug
Monitoring Program, this funding opportunity has resulted in 21
States receiving new program grants and 13 States netting
planning grants. There are now 25 States operating prescription
drug monitoring programs and eight States with legislation in
place to establish a program.
In addition to the prescription monitoring programs of the
DOJ, the Federal Government has a number of other activities
involving prescription drugs. We are promulgating guidelines
for the appropriate disposal of prescription drugs. These
guidelines urge Americans to take unused, unneeded, or expired
prescription drugs out of their original containers and dispose
of them appropriately by mixing the prescription drugs with
undesirable substances like coffee grounds or kitty litter to
throw them away in the trash. We also are addressing the issue
of prevention and treatment. We have drug-free communities, and
on behalf of ONDCP we administer grants to communities across
the country to form local anti-drug coalitions. We have spent
$1.76 million for our substance abuse prevention and treatment
block grant, $504 million in prevention and treatment
discretionary grant, including our Access to Recovery, our ATR
grant. We also have a screening and brief intervention grant.
Furthermore, the National Institute of Drug Abuse has initiated
a research program looking at the use of Buprenorphine for the
treatment of prescription opioid abuse.
As I stated earlier, the emerging challenge of prescription
drug abuse and misuse is a complex issue that requires
epidemiologic surveillance, distribution chain integrity,
intervention, and more research by private and public sectors.
It requires a concerted effort by many, and electronic
monitoring systems are a key part of the response, along with
treatment and prevention programs that include outreach and
education. SAMHSA is committed to allowing programs to give
States and the local authorities the flexibility they need to
deal with the issue and meet the challenge. Our strategy of
prevention and treatment is essential to that.
Thank you for the opportunity to present this information
to you.
[The prepared statement of Dr. Clark follows:]
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Mr. Stupak. Thank you, and thank you for your testimony. We
will begin questions. We will go 5 minutes. If need be, we can
go back and forth. Dr. Clark, in your testimony you never
mentioned the NASPER Program. Why is that?
Dr. Clark. At this particular point in time, the NASPER
Program has not been funded, but the components of NASPER are--
we are actively engaged in addressing some of those components
and working----
Mr. Stupak. Well, if it hasn't been funded, how can you be
actively engaged in addressing the components?
Dr. Clark. We are involved in the issue of collecting data
on prescription drug abuse.
Mr. Stupak. Why didn't you fund NASPER or the program that
you have then to help inform doctors of the problems of the
prescription drug abuse?
Dr. Clark. Well, we understand that the funding process is
complex. It is my understanding that, through the
appropriations process, Congress has chosen to fund these
activities within DOJ and not HHS.
Mr. Stupak. Well, as Mr. Whitfield said, there was $5
million for the NASPER Program brought on approximately 2 years
ago. What ever happened to that $5 million for the NASPER
Program then?
Dr. Clark. To my knowledge, we never got $5 million.
Mr. Stupak. Has SAMHSA ever asked for money for the NASPER
Program?
Dr. Clark. I am not in a position to discuss the internal
deliberations that occur in----
Mr. Stupak. I am not asking for internal discussions. I am
asking if you ever made a request of the appropriators for the
NASPER Program. That is nothing internal. Did the Department
ever ask for funding for the NASPER Program? That is a public
statement. Did you ever do that?
Dr. Clark. Asking for funds for specific programs is an
internal process that we use, and we follow the internal
processes to achieve that.
Mr. Stupak. Why is the budget then published every year, if
it is an internal process? It is a public process. The
President sends his budget to Capitol Hill, and then we discuss
whether or not to do it, whether or not to fund certain
programs. Has the Department ever made a request to fund
NASPER?
Dr. Clark. To my knowledge, no.
Mr. Stupak. From a public health perspective, what do you
believe are the most important features of NASPER as
distinguished from the unauthorized grant program at the
Department of Justice?
Dr. Clark. I think one of the most important things is that
we want to be able to educate and inform practitioners, and we
get that from the Department of Justice program. We want to
make sure that there is this balance between the appropriate
use of pain medications and the inappropriate use of pain
medications. As I mentioned, there is some 75 million people
who suffer from severe pain in the United States. So the
concerted strategy that we are working with in the Federal
Government, we believe, will assist us in addressing these
issues in a cost-conscious environment.
Mr. Stupak. Well, those two that you pointed out, to inform
and educate the doctors who prescribe prescriptions, and also
the use of pain medication, that is not found in the Rogers
program in the Department of Justice, is it?
Dr. Clark. I am not the best person to comment about the
elaborate components of the Department of Justice programs.
Mr. Stupak. Well, you testified on the Department of
Justice program, so why can't you comment on the Department of
Justice programs?
Dr. Clark. I think the Department of Justice programs, in
order to speak with the extreme authority, I think it would be
best for the Department of Justice to comment. We do know that
the Department of Justice is very much interested in advancing
the public health component of theirs and not simply to aid in
investigation and law enforcement. We know that they are----
Mr. Stupak. Well, let me ask you this one, then. Let me ask
you this. Last night at 8 o'clock, your Agency gave our
investigators, 8 o'clock last night, a study required by the
NASPER legislation. The study was supposed to be presented to
Congress. That was supposed to be done 6 months after the bill
was signed into law, which would have been August 2005, so
early 2006 we should have received that report. We never saw
the report until last night at 8 p.m. So why was this study a
year and a half late? And when was this study completed?
Dr. Clark. The study was released yesterday. It required
extensive deliberation. We have discovered----
Mr. Stupak. When was the study completed? I know you
released it last night at 8 o'clock. When was it completed?
Dr. Clark. The study was completed after it was approved,
and I think part of the----
Mr. Stupak. When was it completed, after it was approved?
Dr. Clark. It was approved yesterday, sir.
Mr. Stupak. So it took you 18 months to approve this study?
Dr. Clark. Yes, sir.
Mr. Stupak. How long did it sit in the Department, trying
to get its final approval?
Dr. Clark. I think the Department acted upon the report
with dispatch and due deliberation, so it is not possible for
me to comment on where it was after it left, because we have
been exchanging comments and deliberations on it. So we have
been actively involved in addressing the specifics of the
report.
Mr. Stupak. So you are telling me under oath here today
that you have been actively and specifically going over this
report for the last 18 months?
Dr. Clark. Well----
Mr. Stupak. Isn't the real answer was, you knew you were
called up before this committee, so therefore you released your
report last night? You haven't been actively engaged in this
report. I can tell that just by looking at the report we saw
last night, and I am reminding you, you are under oath. I am
not trying to give you a bad time, but when we ask for things
and you come here and you say you have been actively engaged in
this thing for the last 18 months, studying it, and that is why
it just got released last night, that is a bunch of bull. There
is no other way to put it.
Ms. DeGette. Mr. Chairman, if I may. I always say there is
a good reason to have a hearing. You get so much information
the minute you schedule the hearing, so this is just yet
another example of it.
Mr. Stupak. So, do you want to revise your answer on that
last one? Or are you going to stick with actively engaged for
the last 18 months?
Dr. Clark. Oh, we were pursuing the report as expeditiously
as we could, and the final deliberations of the report were
completed when the report was released.
Mr. Stupak. Mr. Whitfield for questions, please.
Mr. Whitfield. Thank you, Chairman Stupak. Dr. Clark, you
mentioned in responding to Mr. Stupak that HHS did not request
any funding for NASPER. Is that correct?
Dr. Clark. Yes, sir.
Mr. Whitfield. And how was that decision made?
Dr. Clark. Again, I am not at liberty to discuss the
internal deliberations that occur every year during the
preparation of our annual budget.
Mr. Whitfield. Well, Secretary Thompson came and testified
before this committee and said they supported NASPER, that it
would be helpful to them in dealing with this problem.
Secretary Leavitt came to this committee, testified to this
committee, that NASPER would be helpful to them to solve this
problem. And you are testifying this morning that you all did
not request any money from OMB in your budget request. Is that
correct?
Dr. Clark. I am testifying that I am not at liberty to
discuss the internal deliberations that occur----
Mr. Whitfield. No, but I thought you said you did not
request any funds for this program.
Dr. Clark. In the public, published budget.
Mr. Whitfield. All right. Now, Secretary Leavitt also said
that it was OMB's decision not to fund this program. Can you
make a comment on that?
Dr. Clark. I will defer to Secretary Leavitt's comments.
Mr. Whitfield. Well, the point that I would make is that it
is quite obvious from the charts that Dr. Paulozzi has
mentioned here and has shown us that the unintentional drug
poisoning death rate continues to increase. And which would
indicate that this program at DOJ maybe is not being as
effective as it could be. Now, the reason that we were excited
about NASPER was that the first prescription drug monitoring
program in America was established in 1939 in California. And
today there are 25 States that actually have operational
programs. So, from 1939 until 2007, only 25 States have
operating programs. NASPER mandated that States do certain
things to get these programs up and operational, and as we
stated earlier we had a lot of hearings on this issue. We
didn't just run an appropriation bill, and put it in an earmark
to establish a program. We had extensive hearings, a lot of
testimony, and the thought was that this program is much more
comprehensive, has guidelines and so forth, and would be much
more effective. Now, let me ask you, has HHS or SAMHSA taken
any steps to prepare for administering NASPER in the event that
funding is provided?
Dr. Clark. We have had internal discussions. We have worked
with the medical groups. We have sent staff to the various
meetings on prescription monitoring programs, and in fact we
also have an internal working group on electronic health
records, which we believe would be a component of this. We
understand that electronic prescribing is a concept that is
being promoted, and we believe that, should this issue mature,
we would need to be able to address that. So, yes, we have been
addressing some of the collateral issues that we think are
essential to prescription monitoring.
Mr. Whitfield. I might also say that we feel like in NASPER
there are standards in there protecting patient privacy, which
we think are superior to the DOJ program. I would also say that
NASPER requires that dispensers like pharmacies report each
dispensing of a controlled substance no later than one week
after the date the drug was dispensed, and I don't think that
is required on the DOJ program. And as far as interoperability
of these programs, I mean, it is quite obvious that under the
DOJ program not all these States are able to share information
with each other. And I would just ask Dr. Paulozzi, how often
do you all work with HHS? You are at the Centers for Disease
Control. Do you all have a continuing dialogue with HHS on
specific programs to address this unintentional drug death
issue?
Dr. Paulozzi. Well, Congressman Whitfield, we have had
ongoing discussions with various staff at HHS. We worked with
them very closely on the Fentanyl-heroin contamination issue of
a year or two ago, and subsequently I have been keeping in
touch with Dr. Hoffman at SAMHSA on various issues. But our
conversations have not focused on the prescription drug
monitoring program.
Mr. Whitfield. Thank you. My time has expired.
Mr. Stupak. Ms. Schakowsky, for questions, please.
Ms. Schakowsky. I noticed that you said that you are
testifying on behalf of your Administrator, Terry Cline, who
was not able to be here. What I am also noticing as a
consequence, you are not really able to talk about the funding
issues, and I am disappointed in that because that is really at
the center of what this hearing is about. We are trying to
really get at why it is that NASPER has not been implemented
within HHS. Do you think you are the best person, and, believe
me, I am not challenging your role as a psychiatrist and your
role at SAMHSA, but do you think you are really the best person
that can explain what this committee is trying to get at?
Dr. Clark. I think the committee is going to be meeting
with the director of OMB, and you have already met with the
Secretary on this topic, so I think those are the best people
who can comment on this issue.
Ms. Schakowsky. Well, we are going to do our best. The
study that was presented to our staff last night, HHS states
that there is no evidence of negative impact on patients'
access to pain treatment, particularly access by children to
medicines they need. That is under the current system, which is
the DOJ grant program system. I wonder if you could elaborate
on that and if there is a chilling effect on physicians because
of the current system?
Dr. Clark. One of the things that the report does
acknowledge is that there is a paucity of general information.
However, based on the modeling that was done, it does appear
that the prescription modeling programs do have a chilling
effect on practitioner behavior. One of the reasons a
comprehensive strategy would be helpful, we are able to provide
feedback to practitioners real time so that, in fact, you don't
have children and adolescents denied care when that care is
legitimate. Massachusetts----
Ms. Schakowsky. But, can I just interrupt for 1 second? Do
you think the fact that it would be this program, to the extent
that it is implemented, with the prescription drug monitoring
programs in selected States, but the fact that it is housed in
a law enforcement agency, do you think that would add any
additional negative impact?
Dr. Clark. Our hope is that it would not.
Ms. Schakowsky. What do you mean?
Dr. Clark. Well, if in fact we are able to establish the
linkages between the DOJ program, the HHS programs, and
clinical practice, then we would not have a chilling effect.
Ms. Schakowsky. Does the DOJ program provide for this
coordination of agencies?
Dr. Clark. I think the DOJ is attempting to achieve that.
Ms. Schakowsky. So, so far there has not been any
coordination. Do they coordinate with your agency?
Dr. Clark. Not on a routine basis.
Ms. Schakowsky. It appears that most States with these
PDMPs, would the PDMP legislation choose to have their program
in health agencies rather than in their law enforcement
agencies? I wonder if you could comment on that.
Dr. Clark. From the public health point of view, it appears
that in a number of jurisdictions most of the people requesting
information are actually prescribers. For instance, Kentucky's
program, the group requesting reports tends to be, 92 percent
were prescribers, three percent pharmacists, three percent law
enforcement, 1 percent licensing board. So the issue is, how do
we help physicians make proper decisions in the care of their
patients? And we have got a system that allows for real-time
exchange of information. We are able to facilitate that.
Ms. Schakowsky. Thank you. I yield back.
Mr. Stupak. Mr. Murphy, for questions, please.
Mr. Murphy. Yes, Mr. Chairman, just a couple quick ones.
This Department of Justice program, how long has it been going
on, Dr. Paulozzi? My understanding is, about five years or so?
Dr. Paulozzi. Are you referring to the Harold Rogers
Program, Congressman?
Mr. Murphy. Yes.
Dr. Paulozzi. I am sorry. I don't really know when that
program began.
Mr. Murphy. My understanding, it was first funded around
2002. When I think of the slides you were showing us, it
appears that during that time we have seen some pretty dramatic
increases in drug poisoning and death rates.
Dr. Paulozzi. That is correct, Congressman.
Mr. Murphy. And on your slide you were also indicating
that--I am not sure if it is saying it is a correlation, or it
is cause and effect that, with regard to the increase in the
use of these opioids and other analgesics?
Dr. Paulozzi. The trend lines parallel, which is consistent
with a causal relationship. It certainly doesn't prove one.
Mr. Murphy. And in the breakdowns in the testimony today,
there is several factors that relatives may give the drugs
away, some sell it, a small percentage are stolen from doctors'
offices and prescriptions, but generally we trace it with these
drugs. My question is this, is the Department of Justice
program working?
Dr. Paulozzi. Congressman Murphy, it is difficult to tell,
without a formal evaluation of that process. It is hard to know
what the rates would have been without interventions in
prescription drug monitoring programs in selected States.
Mr. Murphy. Sure. A good point. I appreciate that. What I
am wondering here is, when I look back on some testimony that
Secretary Leavitt had here, and it was actually in response to
some questioning from my colleague, Mr. Whitfield, in reference
to the NASPER Program he says, ``It is a program we support. It
is a program we would gladly administer.'' He went on to say
that it was OMB that recommended it be in the law enforcement
program. My question is, to each of you, is there a value in
doing the NASPER Program, even from the point of an armchair
analyst, since it is not that it has been tried and found
wanting, it has been unfunded and left untried, it seems to me.
Am I correct in that assessment, that without the funding we
don't know if it works, but we clearly know that the DOJ
program is, during the time that that is in place, we are
seeing an increase in these deaths? I would like both of you to
answer that, too, if you could respond, please. You can point
at each other. That is fine.
Dr. Paulozzi. As I say, it is difficult to determine what
the impact is of Harold Rogers or without a formal evaluation
or rigorously-done evaluation to determine what the impact of
NASPER could be. As I say, I think it is difficult to infer
evidence of effectiveness or lack of effectiveness from the
information we have here.
Mr. Murphy. Will CDC be doing that kind of evaluation, to
find out if it is working or has a value?
Dr. Paulozzi. We actually do plan a study to look at the
impact of the initiation of prescription drug monitoring
programs of all kinds on the drug fatality rates in the States
that implement them.
Mr. Murphy. Dr. Clark?
Dr. Clark. Should it be decided that NASPER should be
funded, I think Secretary Leavitt's comments would answer your
concerns. So I will defer to Secretary Leavitt's comments on
this matter. Clearly, the Department is pursuing a number of
initiatives which would envelope the NASPER issues and would
allow an aggressive participation and monitoring of what is
going on without sacrificing patient care.
Mr. Murphy. Well, and I would hope we are all on the same
page with this, so all I am trying to find is the most
effective, most efficient way, and it seems to me when we team
up with people who are involved with law enforcement and those
who are involved with healthcare delivery monitoring, we could
have some value here. I mean, when we are looking at even such
things as electronic medical records, with which one can track
who is doing the doctor shopping and getting duplicate drugs,
it is a question that the physician can actually bring up with
the patient in the confidential realm of the doctor's office,
not necessarily waiting for the law enforcement officials, but
to say, Mr. Jones, I think you have gone to several doctors
here, and you are taking an awful lot of Oxycontin here. I am
very concerned. And I don't know if the DOJ program allows that
to happen. Is it? I mean, by design, does the DOJ program allow
that? Do the physicians have access to that kind of information
when they are seeing a patient?
Dr. Paulozzi. My understanding is that there is nothing
blocking their access to that information, but I would defer to
people who know more about it than I do.
Mr. Murphy. I am referencing, and there was an article that
appeared a couple weeks ago in a newspaper in Pennsylvania, in
Kittanning, Pennsylvania, Armstrong County, which is not in my
district, but I was reading here a quote from a law the
Armstrong County district attorney, Scott Andreassi. He said,
``What is not happening now is monitoring things like doctor
shopping. We need to take this program a step further and
involve the pharmacies and virtually everyone involved with
prescriptions every step of the way. We are going to discuss it
in the future as to how we are going to talk to one another,
exchange information on prescription drugs and so on.'' And it
makes me wonder, unless there is a misunderstanding of these
programs, I am wondering if we are getting the right
information to the right people who can really do the right
thing for patient care? And I would think that those are under
the jurisdiction of HHS and CDC, that we are concerned about
people abusing drugs, doctor shopping, illicit prescriptions,
et cetera, and looking at these together. I would hope that
from the comments that both of you made you are going to help
this committee get that information and can bring it to the
committee's attention in the future. I yield back.
Mr. Stupak. Thank you. Ms. DeGette, do you have questions?
Ms. DeGette. Thank you, Mr. Chairman. Dr. Clark, in your
prepared testimony, you say, ``Our strategies in prevention and
treatment of prescription drug abuse are both targeted
specifically to the prescription drugs themselves and to
programs that enable prevention, intervention, and treatment of
addictions, which can have a significant long-term impact on
prescription drug abuse and misuse.'' That is your conclusion.
So my question is to you, if those are your strategies, don't
you think it would be really helpful to have NASPER to help you
achieve those strategies?
Dr. Clark. Clearly, having access to the electronic matrix
where information is shared real-time between pharmacists and
physicians and patients, through their physicians or healthcare
provider, we would be in a much better position to assess the
appropriateness of a particular prescription. As a physician, I
used to work for the VA, and we had electronic records. And so
when a patient would come in, I could pull up those records,
and I could see what medication the patient was on, and I could
deal with the issues of synergism, multiple prescriptions, and
appropriate----
Ms. DeGette. And that is part of what NASPER does, correct?
Dr. Clark. That is part of what NASPER does, yes.
Ms. DeGette. So I guess your answer would be, yes, that
would assist you in these important goals of your agency.
Dr. Clark. Yes.
Ms. DeGette. Dr. Paulozzi, I just have a question. I was
interested to look at your slide that shows that these
incidences of deaths from overuse of these drugs, both in my
area of the country, the southwestern United States, and also
in Appalachia, are greater, and I was wondering if you have any
indication of why that might be. Is it a systems breakdown? Is
it for cultural reasons? What might the reasons be?
Dr. Paulozzi. Well, thank you for that question,
Congresswoman DeGette. New Mexico used to have the highest drug
poisoning mortality rates in the country for many years. And it
was thought to be related to the black-tar heroin, some of it
coming in from Mexico, also related to maybe the cultural
practices of use of heroin in that community. Some of the
neighboring States to New Mexico's rates have gone up, though,
in the last 10 or 15 years as well, so it is not clear to what
extent that is prescription drugs and to what extent it is
illicit drugs. But that has really historically been the focal
point for drug poisoning, in the Southwest.
Ms. DeGette. And we don't really know why exactly?
Dr. Paulozzi. No, I would have to say that there are
speculations about illicit drugs and type of heroin use in
cultural practices.
Ms. DeGette. In your testimony you mentioned a variety of
surveillance and examination activities that the CDC will
undertake this year, such as looking at prescription histories.
This is one of the things NASPER does. It gives doctors and
officials access to patient histories. So wouldn't it make
sense to use the NASPER Program for this, and especially since
it has already been authorized?
Dr. Paulozzi. Yes, absolutely, Congresswoman. The
information collected by prescription drug monitoring programs
could be very useful to people like myself or State health
departments, public health researchers at all levels, to look
at the prescription histories of people suffering overdoses, to
look at the trends in distributions, in county-by-county
distributions across the State. I think it is an invaluable
tool.
Ms. DeGette. And you have reported unintentional deaths
from prescription drug abuse is now the second cause of
accidental deaths in this country, second only to traffic
accidents. If NASPER is implemented by HHS, how would the data
from PDMP programs help medical researchers engaged in public
health research, like you?
Dr. Paulozzi. Well, the data would be very helpful,
Congresswoman, in terms of telling us what is happening with
distributions of drugs and trends in sales of drugs. We
currently don't have a good source of information about that.
Proprietary information is available, but working in the public
sector, we can't afford to buy it. In addition, the people
doing studies, and medical examiners, just looking at the
deaths of individuals, could benefit from being able to see
what their prescription history has been in terms of helping to
determine what led to their death. So there are multiple
applications.
Ms. DeGette. And one thing I was just sitting here thinking
about, like with my question to you about why are the deaths
higher in certain regions of the country, if you had that data
you could actually see, is the use or abuse of these
prescription drugs greater in these areas, or is it really
illicit drugs, a fact that you can only speculate on right now?
Correct?
Dr. Paulozzi. Yes, that would be an additional tool. There
are some survey data, though, that are broken down by State,
collected by SAMHSA, about substance abuse that may be useful
in that regard.
Ms. DeGette. And, Dr. Clark, you were shaking your head.
You think this could be helpful as well, I assume?
Dr. Clark. Yes.
Ms. DeGette. Thank you. Thank you, Mr. Chairman.
Mr. Stupak. Thank you. Dr. Paulozzi, if I may, Ms. DeGette
asked you about, you mentioned New Mexico and Colorado and the
Appalachian States, and in a map of the States you have the
highest drug poisoning rates in the country. And again, in your
opinion, if the prescription drug monitoring programs in those
States had interoperable capabilities, like they would under
NASPER, do you believe that would help decrease the drug
poisoning in those States?
Dr. Paulozzi. Well, Mr. Chairman, I believe that the
prescription drug monitoring programs are promising tools for
that purpose. They would provide a lot more information in a
timely way, both to regulators, people in public health, and
also to physicians in trying to manage care for patients. So
there are a lot of reasons to believe that they would be
effective in preventing overdoses, managing care of people with
chronic pain better.
Mr. Stupak. Your data that you used in your study came from
coroners and medical examiners as to the cause of death. How do
coroners and medical examiners determine what types of
prescription drugs were involved in these accidental deaths?
Dr. Paulozzi. Yes, Mr. Chairman. The coroners and medical
examiners do complete the death certificates, which are filed,
and then those become the source of the studies that we have
done. They determine the cause of death by a variety of means.
They look at the death scene investigations to see what
prescription vials are there and whether there are syringes
that were used to inject drugs. They also, of course, do
toxicologic testing to look for the drugs found in the
decedents' bodies after death. They will ask questions about
the person's history, and they may even get the record from the
prescription drug monitoring program, if there is one in their
State, about the person's prescription history, to look for
signs of abuse of drugs.
Mr. Stupak. If we had NASPER, that would provide that
information readily available to those coroners and others,
would it not?
Dr. Paulozzi. Yes.
Mr. Stupak. About the prescription drugs?
Dr. Paulozzi. Yes, Mr. Chairman, it would.
Mr. Stupak. Thanks. In your testimony you mentioned that
there is a significant correlation between State drug poisoning
rates and State sales of prescription drugs. If you were in
charge of creating a drug monitoring program such as NASPER,
would you choose to house it in a health agency which has
jurisdiction over prescription drugs or a law enforcement
agency like DOJ, and why?
Dr. Paulozzi. Well, that is a complicated question, and I
am not sure I really understand fully the ramifications of
those two different choices. I can say on the one hand that
there is a lot of use made of prescription drug monitoring
program data by law enforcement. On the other hand, there
should be use of NASPER-type data by physicians. I would hope
for a system that would be accessible to everyone who needed
access to it, with the appropriate protections of patient
privacy, and not have the use be dictated by the location of
the program.
Mr. Stupak. Thank you. Dr. Clark, in the study you gave to
our staff last night, and SAMHSA spent 18 months massaging it,
let me ask you this. In there, it states that there is evidence
of a negative impact on the patient's access to pain treatment.
Are you saying that the Harold Rogers program is negatively
impacting patients' ability to seek proper treatment on
legitimate pain diseases?
Dr. Clark. No, what we are saying is, looking at controlled
substance monitoring programs generally so that comment is not
targeted toward the Harold Rogers Program. It is saying that
when jurisdictions implement controlled substance monitoring
programs, there is an unintended consequence of practitioners
altering their clinical decision-making because of the
existence of such programs.
Mr. Stupak. The Rogers prescription drug monitoring program
has been around since 2002. Congress has spent $43.5 million.
Has anyone ever assessed the success of that program, if it has
been successful in reducing unintentional deaths in drugs, Mr.
Clark?
Dr. Clark. I don't think so.
Mr. Stupak. All right. In your testimony you say that no
organization or agency can address the program or the problem
alone. A coordinated response is required. Does the Rogers
program provide this coordination of agencies?
Dr. Clark. I think under the one-government paradigm we
should be operating with that level of coordination. It hasn't
happened.
Mr. Stupak. So the Rogers program doesn't support
coordination amongst agencies, then?
Dr. Clark. I can't articulate the explanation for the
Rogers program's activity in that area.
Mr. Stupak. Well, let me ask you this. Does HHS support the
NASPER Program?
Dr. Clark. You have heard from Secretary Leavitt. I will
defer to his position on this matter.
Mr. Stupak. Has Secretary Leavitt seen this report that you
handed to us last night?
Dr. Clark. That report has been cleared by HHS. I can't say
whether Secretary Leavitt himself has seen the report.
Mr. Stupak. Mr. Whitfield, for questions.
Mr. Whitfield. Just a couple more. Obviously on an issue as
serious as this issue, it is important that the programs, that
they be effective and that there be a way to measure their
effectiveness and that there be adequate oversight. And I would
make the argument that, when you do an earmark on an
appropriation bill, generally there is no follow-up report to
examine its effectiveness at all. In NASPER, there is a
requirement that after three years of operation that HHS
conduct a study and determine how effective the program is. So
I think that is one big difference in these programs. The
second difference is that, under the existing DOJ program, it
relies on the States to determine who has access to the
information. And, for example, Indiana and Pennsylvania will
not allow physicians access to the information. The NASPER
Program allows physicians access to the information, allows law
enforcement access to the information, and sets guidelines for
privacy protection concerns. So when you look at these
programs, I think the more balanced program overall certainly
is NASPER and I must say that it is frustrating that the
President signs this bill, and still there is no funding for
this program. And it is more important than just jurisdiction.
It is about addressing a serious problem in the country, and
that is really what this hearing is all about. Now, Dr. Clark,
let me ask you one question. When you all work with OMB on your
budgetary needs, who, what is the name of the individual at OMB
that you work with? I mean, I know that Leavitt can call Jim
Nussle on the phone, or he can call Rob Portman on the phone,
but at the staff level, who works with who? Between HHS and
their budget requests and OMB?
Dr. Clark. As I recall, the staff person is an individual
named Patricia Smith.
Mr. Whitfield. Patricia Smith? And then, at the White
House, who is the White House liaison with HHS?
Dr. Clark. I don't have that information.
Mr. Whitfield. Thank you very much.
Mr. Stupak. Seeing no members with further questions, I
would like to thank this panel for their testimony today. Dr.
Paulozzi and Dr. Clark, thank you for being here.
Dr. Clark. Thank you.
Dr. Paulozzi. Thank you.
Mr. Stupak. We will call up our second panel. We have one
witness on our second panel, and that is Dr. Andrea Trescot,
president of the American Society of Interventional Pain
Physicians, and she is also the director of Pain Fellowship at
the University of Florida. We will give you just a minute, Dr.
Trescot, and then we are ready to go. It is the policy of this
subcommittee to take all testimony under oath. Please be
advised that the witness has the right, under the rules of the
House, to be advised by counsel during their testimony. Do you
wish to be represented by counsel, doctor?
Dr. Trescot. No, sir, I do not.
Mr. Stupak. The witness testifies that she does not, then
raise your right hand and take the oath.
[Witness sworn]
Mr. Stupak. Thank you. Let the record reflect the witness
has answered in the affirmative. She is now under oath. Dr.
Trescot, if you would, please, just give an opening statement,
and then you may submit a longer statement for inclusion in the
record, and we look forward to questions and answers. Doctor?
TESTIMONY OF ANDREA M. TRESCOT, M.D., PRESIDENT, AMERICAN
SOCIETY OF INTERVENTIONAL PAIN PHYSICIANS; DIRECTOR, PAIN
FELLOWSHIP
Dr. Trescot. Thank you. Distinguished Chairman, ranking
member, Members of Congress, and staff, my name is Dr. Andrea
Trescot. I am very grateful for this invitation to speak before
you regarding a critical issue, prescription drug abuse. I am
an interventional pain physician with nearly 20 years of
private practice experience, and earlier this year I left
private practice to join the University of Florida and the
Gainesville VA as Director of the Pain Fellowship Program. I am
currently the president, as you said, of the American Society
of Interventional Pain Physicians, ASIPP, a professional
society with over 4000 providers. But it is in my role as a
physician, treating patients in agonizing pain, that I come to
you today requesting your help.
Opioid or narcotic use and misuse is a huge and growing
problem in the United States. As you have heard, Americans make
up only 4 percent of the world's population, but they consume
nearly 80 percent of the global supply of pain medicines, 99
percent of the global supply of hydrocodone, one of our very
easily obtained opioids, and two-thirds of the world's illegal
drugs. Despite billions of dollars thrown at this problem we
have not been able to reduce the Nation's substance abuse and
addiction.
The number of Americans abusing controlled substance drugs
has jumped from 6.2 to 15.2 million in the last 10 years. Among
chronic pain sufferers who receive opioids, one in five abuse
those medications. The number of teen users, who somehow view
prescription medicines as being safer, has more than doubled,
but the highest use of pain relievers, non-medically, has been
in the 18- to 25-year group. An undercover surveillance video I
viewed last week of a pill mill showed nearly 100 people
standing in a doctor's waiting room, waiting to pick up their
narcotics. I was stunned by how much it looked like a bar scene
and then realized it was because virtually person in the
waiting room was under the age of 30. Unfortunately, the
elderly are also at risk because of their multiple medications
and potential drug interactions and their multiple degenerative
joint changes. Though this population may have significant and
legitimate opioid needs, they are at risk for diversion of
their medications, sold for income supplementation or stolen by
caregivers and family members.
Approximately 75 to 90 percent of drug abusers have
obtained their medications legally, and most through a
prescription. We feel, therefore, that the most effective way
of controlling this epidemic is to control the end of the pen,
or in other words, how the medicines are prescribed. The White
House Office of National Drug Control Policy, focusing on
stopping use before it starts, healing drug users, and
disrupting the market, has spent over $10 million a year since
its enactment in 1988, with no demonstrable curb in drug abuse
or addiction. And yet, almost a quarter of a trillion dollars
of the Nation's yearly healthcare bill is attributed to
substance abuse and addiction.
We feel strongly that NASPER is a major weapon against
prescription drug abuse. Unfortunately, the ONDCP's budget of
$13 million doesn't include funding for NASPER, which is
arguably the most effective program. To fight drug abuse before
the drug is prescribed would require about $10 million, which
is less than 1 percent of the current budget and could provide
as much as 30 percent reduction in prescription drug abuse. Now
NASPER was based, as you have heard, on a successful program in
Kentucky, KASPER, which has been effective but limited because
Kentucky has seven border States, allowing patients to take the
prescriptions across State lines to avoid monitoring. One of
the most important features of NASPER was the information
sharing across State lines, but that requires each State to
have a monitoring program in place. In this day of unfunded
mandates, the States have been slow to enact legislation, most
of which was inadequately funded and not designed to share
information.
I live in north Florida, an hour away from the Georgia
border. Although Florida passed a bill that was named FLASPER,
suggesting that it was part of the NASPER Program, the eventual
legislation was castrated into a voluntary program of
electronic prescribing. We are convinced that, had the funding
for NASPER been in place, the law in Florida would have
conformed to the national recommendations, which would have
prevented Florida patients from obtaining narcotics from
multiple doctors, whether they were day laborers or syndicated
radio columnists. By identifying those patients who are doctor
shopping, physicians will be able to intervene early with
patients who are misusing and abusing their medications,
legitimate pain patients will receive access to care they truly
need, and we can shut down the most obvious avenue for
obtaining fraudulent prescriptions.
It is clear the prescription monitoring programs are
effective specifically when they are proactive, and we feel
NASPER is just such a program. We at ASIPP also feel that,
since less than 40 percent of physicians receive any kind of
training regarding pain evaluation in medical school, the White
House should facilitate the dissemination of pain and addiction
information to the general medical community. I have provided
the committee with a copy of such an education tool, published
last year by the Florida Medical Association.
In closing, the White House has declared a total global war
on terrorism, with a budget of $145 billion. We are asking for
only a tiny fraction of that to battle an insidious and just as
deadly internal threat to the welfare of this great Nation.
Please help us in that battle by providing funding for NASPER
as one of the major tools we have in this critical battle.
Thank you very much, and I look forward to answering any
questions you might have today and in the future and perhaps
providing additional insight to some of the questions asked
today.
[The prepared statement of Dr. Trescot follows:]
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Mr. Stupak. Thank you, and I will note you had presented
longer testimony, and some of it was a paper done by Dr.
Laxmaiah Manchikanti.
Dr. Trescot. Manchikanti, yes, sir. And that is available
in your packets. That has been published and available on the
Web as well.
Mr. Stupak. Right, and then that will be included in the
record. But I know with the great frustration that our
witnesses on the previous panel from CDC and SAMHSA, officials
did not stay to listen to your testimony. I wish they would
have, and I would like to send them a copy of your testimony
and a copy of the pill mill tape that you did, you shot last
week, you said.
Dr. Trescot. Yes, sir.
Mr. Stupak. And so, could you send the committee a copy of
that tape? We would really like to see it.
Dr. Trescot. I can actually provide--CBS Evening News did
one actually of Texas, which I was asked to comment on, on air.
The surveillance that I described is on a case that is
currently ongoing, and certainly as soon as that case has
adjudicated I am sure that we would be glad to provide that.
Unfortunately, because that case is----
Mr. Stupak. Ongoing.
Dr. Trescot. That organization is actually currently being
investigated. I am not at liberty to release that information.
Mr. Stupak. When it is, and when you can, if you would,
please provide the committee.
Dr. Trescot. I will do the best of my ability.
Mr. Stupak. It is a great learning tool. Now, one of the
things that, and having practiced medicine I am sure you are
well aware of it, we have seen, and it seems like I always hear
stories every week, that all they did for a senior citizen was
change their medication when they went to the hospital, or the
medication being received from their family physician and what
they received in the hospital was counteractive to the illness
or the disease they are trying to prevent. Would NASPER help
change that or get better outcomes here? It seems like we are
prescribing, multiple doctors prescribe multiple medications,
which does not really help out the patient at times.
Dr. Trescot. That is absolutely a huge problem. Many
patients now are treated at the hospital by a hospitalist and
now their family doctor, and there is often a delay in getting
the information from the hospital back to the primary care
physician, and unfortunately patients in general don't often
recognize that the name of one medicine might be the same kind
of medicine as another. And a good example of that would be the
difference between Vicodin and Lortab----
Mr. Stupak. Sure.
Dr. Trescot. Both of which are hydrocodones, both of which
have very different names, and I in my own practice have had
patients who have been on both medicines and had no clue they
were exactly the same. That obviously raises the risk of
overdose because they are taking two doses of the same
medicine. NASPER would allow us to be able to access that
information from all their locations, from all the prescribers,
and to be able to sit down with the patient and, medicine by
medicine by medicine, be able to look at the potential drug
interactions.
Mr. Stupak. Well, let me ask this question. The NASPER
Program, there are requirements for receiving grant funds that
a State has agreements with bordering States to share
information in order to stop the doctor shopping between the
States, and you mentioned Florida being an hour away from
Georgia. Do you see the effects of Georgia dumping there, or
patients going over to Florida from Georgia and vice versa?
Dr. Trescot. There is actually a pill mill in my own
community, and you can drive by that office and see the huge
number of Georgia license plates in the parking lot.
Mr. Stupak. I think Mr. Burgess might have mentioned it.
You have mentioned it. It seems like we are aware of where
these pill mills are, but who would have the responsibility for
controlling or shutting them down?
Dr. Trescot. That is why I volunteered to be the expert
witness in this ongoing case, but this particular pill mill has
been in existence since April. They have a physician who had
never written--sorry--controlled substances before who in
September, from April until September, had written at least
8,800 different prescriptions for opioid narcotics, out of this
one location.
Mr. Stupak. So in order to write prescriptions you have to
be licensed, so you have a State licensing agency, you have a
law enforcement issue, and you have a public health issue,
which NASPER takes those components in consideration, but, with
all due respect to the Rogers Program, that is more oriented
towards law enforcement. Has that been your experience?
Dr. Trescot. Absolutely, and the problem comes in, is that
there is no way for me as a provider, you come into my office
complaining of low back pain. I have no test for pain, I have
no ways of telling by looking at you whether you are really
hurting or not. So I have two options. One is to consider you a
potential drug abuser and refuse you the pain medicines you
might need. The other is to be an enabler, to allow you to be
able to scam me, just as you have scammed other doctors in the
community, by writing a medicine because I believe you. So it
immediately sets up an adversarial relationship. We feel that
NASPER, because it was written to be HIPAA compliant, requires
a written consent from you to allow me to access that data
bank. Now obviously if you don't give that consent, I don't
write the pain medicine.
Mr. Stupak. Correct.
Dr. Trescot. So it is a quid pro quo. But in any case it
allows me to access the data bank to be able to see that you
have not gotten medicines from any other prescribers, to be
able to identify if you are potentially in trouble, and
intervene before your life is destroyed, and to then be able to
establish a caring, open relationship with you, to be able to
give you the treatment that you deserve.
Mr. Stupak. Two quick questions, if I may. Do you believe
HHS is the appropriate agency to run NASPER?
Dr. Trescot. I absolutely do. HHS is by definition involved
with healthcare. It allows a physician intervention at an early
point, and since the physician, as I said, is the end of the
pen, the physician is writing the prescription that is
therefore getting abused. So it allows it to be done at a
physician level. DOJ focuses on criminal activity, and I will
be honest, for instance, in the Panhandle of Florida there have
been some very egregious DOJ activities against physicians, to
the point that I have physicians telling me that they feel that
there are being attacked by, and the quote is ``jack-booted
thugs''. That has created an amazing chilling effect, so that
patients come to me from the panhandle telling me that they do
not have the ability to get prescription medications in the
panhandle, and they have to come to Gainesville.
Mr. Stupak. Quickly, any other States have a program real
similar to NASPER? We have heard all kinds of figures----
Dr. Trescot. Yes. There are four.
Mr. Stupak. Four?
Dr. Trescot. We have got Kentucky, Utah, Idaho, and Nevada.
Those are the only that allow physicians to have access to that
information. Every other one denies physicians that ability.
Mr. Stupak. Thank you. I am well over my time, but I want
to give you and Mr. Whitfield-- questions please? Thank you
again.
Mr. Whitfield. Dr. Trescot, we appreciate your being here
very much and thank you for the great job you are doing with
the Association, and thank you for providing us with this
magazine. And now that we understand opiate pharmacology we can
have a better conversation with Dr. Burgess over there. But I
am not going to ask you any questions, and here is why. Your
testimony is the kind of testimony that we really needed when
we were passing this legislation, and we had great testimony,
and your testimony reaffirms the necessity for this program.
But unfortunately our problem right now is getting the
appropriations for it. So thank you very much for being here
and for your continued effort in this regard.
Mr. Stupak. Thanks, Mr. Whitfield. I know you have been a
champion on this legislation, along with myself and others, and
we appreciate it, and we are going to get some money to get
this thing going. Mr. Burgess.
Mr. Burgess. Thank you, Mr. Chairman. Thank you, Dr.
Trescot, for being here and sharing this information with us.
You referenced the Texas physician. Was that the same series of
articles that I referenced in my opening statement?
Dr. Trescot. It is actually a different one.
Mr. Burgess. Wow.
Dr. Trescot. This was on the CBS Evening News, was a
physician's assistant, actually, who would see the patients
with no--they had sent in undercover reporters with video, and
it is all videotaped and was presented, where he would come in,
what medicines do you want? There was no attempt at a physical
exam, no attempt at trying to obtain a history. The reporters
were asked at the window if they had records. They said, no.
They said, fine. That will be $150 or $200 or $80, whichever
one it was at that particular time. They came into the room.
They had a blood pressure or weight taken, and then the
physician's assistant, describing himself as a doctor, came in
and said, what do you need? They asked for the medicines they
wanted. The prescription was faxed over to the pharmacy, and
actually they got medicines that they didn't even ask for, and
with four reporters that went in, they got over 700 tablets in
four days of addictive substances.
Mr. Burgess. Are you familiar with the case that I
referenced, Dr. Maynard in south Dallas?
Dr. Trescot. Yes, sir, and it is very similar to the ones
that we are looking at in Florida and disgustingly similar
unfortunately.
Mr. Burgess. And even with all of the documentary evidence
that they brought up, this individual was given probation, and
I guess he lost his license. I don't really know about that,
but it seems like it was pretty difficult to build the case and
get--realistically, he was charged with, I think, 11 counts of
murder and gets probation. That is kind of phenomenal.
Dr. Trescot. And yet in the panhandle a doctor who was a
Board-Certified pain management physician, fellowship trained,
seeing 10 patients a day, not 100, had, I believe, two patients
who died. He was convicted and given 20 years in prison.
Mr. Burgess. And that is actually what I was going to ask
you about, because that occurred, I think, before I took office
here. As a physician you worry about how to strike that right
balance. You obviously don't want to bring the wrath of the DOJ
down on your neck, but at the same time you are in the
treatment room with a patient who is suffering, and your charge
is to serve the suffering, so it sets up a conflict that almost
cannot be resolved.
Dr. Trescot. Except through NASPER, and that is what we
think is, with NASPER it allows us to be able to understand
immediately whether or not that patient is drug seeking,
whether or not that patient is at risk for getting into
trouble, and whether or not it is a patient who is actually
legitimate.
Mr. Burgess. Now who would have access to the data in
NASPER?
Dr. Trescot. NASPER was written so that physicians who are
treating the patient, the pharmacists who are dispensing the
medications, and law enforcement, only with the equivalent of a
search warrant, would have access to that information. And so
it is protected information, only released to those people who
have a reason to need it.
Mr. Burgess. What occurs in the instance where the
prescribing physician is the non-treating physician but
covering for someone? I mean, that is the situation where a
drug-seeking behavior--I mean, that would happen almost every
weekend I was on call. Someone randomly picks your name out of
the phone book, say, I am your partner's patient, would you
refill whatever? Either you get tricked or you don't, but how
do you get permission from that patient to access their
database?
Dr. Trescot. And that is a very good question because that
is actually, in my practice we had the policy that, for no
reason, under any circumstances, were medications called in
over the weekend without the ability to review the chart, even
though it might have been one of my partners' prescriptions.
And when the patients came in, they actually signed a sheet
saying that they realized that, and if they had a problem and
needed more medicines they were required to go to the emergency
room, putting an additional burden on our already overburdened
emergency rooms. What we visualize is that you could do the
blanket consent that, so those physicians who have a reason to
have access, whether--it is an agreement. If you have somebody
who is covering you on call, you have an agreement with them
for the exchange of that information, and that consent would
theoretically pass over.
Mr. Burgess. Now, are you familiar with the Genetic
Information Non-Discrimination Act that we just passed?
Dr. Trescot. No, I am not. I was very intrigued when you
said that, and I wasn't familiar with it.
Mr. Burgess. I guess arguably someone could say that the
vulnerability to addictive behavior is an inherited trait, ergo
it is a genetic condition, and we did put some pretty
significant parameters around the sharing of data. I do wonder
if we have encroached upon the turf of NAFTA with--oh, NAFTA--
NASPER with this. On the border State issue, Texas is a border
State with another country. What do we do in that situation?
The trans-border migration in Texas is, of course, the stuff of
legend on Lou Dobbs every evening. It seems to me that this
trafficking is probably just as rampant as it is across the
Georgia-Florida border, if not more.
Dr. Trescot. We can't control the flow of bodies much less
small pieces of paper that are prescriptions or bottles of
medication. Ideally, you would end up with, I would think, a
situation where you could have an agreement with Mexico, but
that is outside my purview.
Mr. Burgess. But many of these substances are not
controlled substances in Mexico, so Texas and California, New
Mexico, and Arizona would have a unique problem in that there
may be the flow of contraband essentially across their borders.
Well, like Mr. Whitfield, I appreciate so much the compilation
of data. I think it is going to be helpful going forward. I
actually wish we had had this when we had the GINA discussion,
but that is an issue for another day. Mr. Chairman, I do hope
we take on the Oxycontin issue, because I think that is
something that this committee should look into, and I know
there have been a lot of requests in that, and I think it is
something we should take up. And I will yield back.
Mr. Stupak. Thank the gentleman. Doctor, thanks.
Unfortunately we have to run to votes right now, but thanks for
being here. Thanks for sitting through the last panel, too. You
did do that, and we appreciate that.
Dr. Trescot. It was my pleasure, and thank you very much
for the invitation.
Mr. Stupak. Thank you, and we will keep on this. We do have
our meeting tomorrow at 3:30 with Mr. Nussle, the Director of
the Office of Management and Budget, and maybe we can get this
funded in the President's request next year.
Dr. Trescot. Well, the help of both of you has been greatly
appreciated.
Mr. Stupak. Thanks. That concludes our questioning. I want
to thank our witnesses for coming today and for their
testimony. I ask for unanimous consent that the hearing record
will remain open for 30 days for additional questions for the
record. Without objection, the record will remain open. I ask
unanimous consent that the contents of our document binder be
entered in the record. Without objection, the documents will be
entered in the record. That concludes our hearing. With no
objection, this meeting of the subcommittee is adjourned. Thank
you again.
[Whereupon, at 11:45 a.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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