[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
THE DRUG ADDICTION TREATMENT ACT OF 1999
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
HEALTH AND ENVIRONMENT
of the
COMMITTEE ON COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
JULY 30, 1999
__________
Serial No. 106-45
__________
Printed for the use of the Committee on Commerce
------------------------------
U.S. GOVERNMENT PRINTING OFFICE
58-503 CC WASHINGTON : 1999
COMMITTEE ON COMMERCE
TOM BLILEY, Virginia, Chairman
W.J. ``BILLY'' TAUZIN, Louisiana JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas RALPH M. HALL, Texas
FRED UPTON, Michigan RICK BOUCHER, Virginia
CLIFF STEARNS, Florida EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio FRANK PALLONE, Jr., New Jersey
Vice Chairman SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania BART GORDON, Tennessee
CHRISTOPHER COX, California PETER DEUTSCH, Florida
NATHAN DEAL, Georgia BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma ANNA G. ESHOO, California
RICHARD BURR, North Carolina RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California BART STUPAK, Michigan
ED WHITFIELD, Kentucky ELIOT L. ENGEL, New York
GREG GANSKE, Iowa THOMAS C. SAWYER, Ohio
CHARLIE NORWOOD, Georgia ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma GENE GREEN, Texas
RICK LAZIO, New York KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming TED STRICKLAND, Ohio
JAMES E. ROGAN, California DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING,
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland
James E. Derderian, Chief of Staff
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Health and Environment
MICHAEL BILIRAKIS, Florida, Chairman
FRED UPTON, Michigan SHERROD BROWN, Ohio
CLIFF STEARNS, Florida HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia PETER DEUTSCH, Florida
RICHARD BURR, North Carolina BART STUPAK, Michigan
BRIAN P. BILBRAY, California GENE GREEN, Texas
ED WHITFIELD, Kentucky TED STRICKLAND, Ohio
GREG GANSKE, Iowa DIANA DeGETTE, Colorado
CHARLIE NORWOOD, Georgia THOMAS M. BARRETT, Wisconsin
TOM A. COBURN, Oklahoma LOIS CAPPS, California
Vice Chairman RALPH M. HALL, Texas
RICK LAZIO, New York EDOLPHUS TOWNS, New York
BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
JOHN B. SHADEGG, Arizona JOHN D. DINGELL, Michigan,
CHARLES W. ``CHIP'' PICKERING, (Ex Officio)
Mississippi
ED BRYANT, Tennessee
TOM BLILEY, Virginia,
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Alexander, Larry L., Baylor Medical Center at Irving......... 50
Anderson, Robert E., Director, Research and Program
Applications, National Association of State Alcohol and
Drug Abuse Directors....................................... 54
Clark, H. Westley, Director, Center for Substance Abuse
Treatment.................................................. 33
Collier-McColl, Jenny, Director of National Policy, Legal
Action Center.............................................. 62
Hatch, Hon. Orrin, a United States Senator from the State of
Utah....................................................... 1
Kosten, Thomas, President, American Academy of Addiction
Psychiatry................................................. 58
Leshner, Alan I., Director, National Institute on Drug Abuse,
accompanied by Frank J. Vocci, Director, Medications
Development Division, National Institute on Drug Abuse..... 27
Levin, Hon. Carl, a United States Senator from the State of
Michigan................................................... 5
Rivers, Odis, Citizen, State of Michigan..................... 48
Schuster, Charles, Director, Clinical Research Division on
Substance Abuse, Wayne State University.................... 44
Material submitted for the record by:
Salvation Army, The, prepared statement of................... 76
(iii)
THE DRUG ADDICTION TREATMENT ACT OF 1999
----------
FRIDAY, JULY 30, 1999
House of Representatives,
Committee on Commerce,
Subcommittee on Health and Environment,
Washington, DC.
The subcommittee met, pursuant to notice, at 9:05 a.m., in
room 2322, Rayburn House Office Building, Hon. Michael
Bilirakis (chairman) presiding.
Members present: Representatives Bilirakis, Greenwood,
Deal, Whitfield, Bryant, Bliley (ex officio), Brown, Waxman,
Stupak, Green, Barrett, Capps and Dingell (ex officio).
Staff present: Marc Wheat, majority counsel; and John Ford,
minority counsel.
Mr. Bilirakis. This hearing will come to order. The Chair
apologizes to the Senators and to the audience for the late
start, but I have been waiting for someone from the other side
to get here. I am not really sure what is happening on the
House floor, but I understand that the Senate has a vote taking
place right now. So we are going to defer even my opening
statement and ask you gentlemen to a testify. I apologize for
not having an audience up here, but hopefully we will get to
read it all. And Patty will advise us anyhow.
Mr. Bilirakis. Senator Levin, please proceed.
Senator Levin. Senator Hatch and I have introduced a bill
which Senator Hatch would describe, I hope, and then he will
leave and protect our turf back in the Senate. Let them know
that I will be a little later than you, but I will be there.
STATEMENT OF HON. ORRIN HATCH, A UNITED STATES SENATOR FROM THE
STATE OF UTAH
Senator Hatch. Yes, I will take good care of you. I
promise.
Mr. Chairman, I want to thank you for allowing both of us
to testify before your subcommittee today. And I always, always
appreciate the opportunity to work with you and other Members
of the House. I am sorry that we have only a brief moment, but
we are, like you say, starting a series of stack votes over
there on the tax bill. So I ask your permission to insert the
entire text of my prepared remarks in the record.
Mr. Bilirakis. Without objection that is the case for both
of you.
Senator Hatch. Earlier this year Senators Levin, Moynihan
and I introduced S. 324, the Drug Addiction Treatment Act of
1999. This is called the DATA Act. Last week Senator Biden
joined us as cosponsor. Now, the goal of this bill is simple,
but it is important. S. 324 attempts to make drug treatment
more available and more effective to those who need it. One of
the most troublesome problems that our Nation faces today is,
of course, drug abuse.
The spectrum of deleterious by-products of drug abuse
include rampant and often violent crime, breakdown in family
life and other fundamental structures, and inability of
addicted individuals to reach their full potential as
contributing members of their communities. Our legislation
focuses on increasing the availability and effectiveness of
drug treatment.
The purpose of the Drug Addiction Treatment Act of 1999 is
to allow qualified physicians as determined by the Department
of Health and Human Services to prescribe schedules IV and V
antiaddiction medications in their offices without an
additional drug enforcement registration if certain conditions
are met. This program will continue after 3 years only if the
Secretary and Attorney General determine that this new type of
decentralized treatment should not continue.
This bill would also allow the Secretary and Attorney
General to discontinue the program earlier than 3 years if,
upon consideration of the specified factors, they determine
that early termination is advisable.
In drafting the waiver provisions of the bill, the Drug
Enforcement Agency, the Food and Drug Administration, and the
National Institute on Drug Abuse were all consulted. In 1995,
the Institute of Medicine of the National Academy of Sciences
issued a report: ``Development of Medications for Opiate and
Cocaine Addictions: Issues for the Government and Private
Sector.'' This study called for, ``developing flexible
alternative means of controlling the dispensing of
antiaddiction narcotic medications that would avoid the
methadone model of individually approved treatment centers.''
The Drug Addiction Treatment Act, DATA, is exactly the kind
of policy initiative that experts have called for in America's
multifaceted response to the drug abuse epidemic.Now, I
recognize that the DATA legislation is just one mechanism to
attack this problem, and I plan to work with my colleagues in
the Congress to devise additional strategies to reduce both the
supply and the demand for drugs.
And, Mr. Chairman, once again I appreciate the opportunity
to testify before your subcommittee today. This legislation
promotes a policy that dramatically improves these lives
because it helps those who abuse drugs to change their lives
and become productive members of society.
In addition, if you would permit me to make one quick and
somewhat sensitive remark about some of the perceived
atmospherics surrounding S. 324, and the SAMHSA reauthorization
bill. In short, I favor moving both bills this session. I would
ask Chairman Bilirakis if he would let my two good friends
Chairman Bliley and Ranking Member Dingell, two of the finest
men serving in the House, in my view--it is my understanding
that it may be the case of my friend from Michigan is upset at
attempts at the end of the last Congress to include S. 324-like
language into the omnibus bill. Let me state in public that I
favored such an endeavor and wrote to the appropriators of my
wishes at that time. Now, this has been a bipartisan effort in
the Senate from day 1. Senators Levin and Moynihan have been
with me every step of the way, and we are pleased to have
recently been joined in this legislation by Senator Biden. And
we have had extensive discussions.
I would ask that the balance of my remarks be placed in the
record at this particular point.
Mr. Bilirakis. Without objection, sir.
[The prepared statement of Hon. Orrin Hatch follows:]
Prepared Statement of Hon. Orrin G. Hatch, a U.S. Senator from the
State of Utah
Mr. Chairman, I want to thank you for the opportunity to testify
before your Subcommittee today.
Earlier this year, Senators Levin, Moynihan, and I introduced S.
324, the ``Drug Addiction Treatment Act of 1999''--the DATA bill. Last
week, Senator Biden joined us in cosponsorship.
The goal of this bill is simple, but it is important: S. 324
attempts to make drug treatment more available and more effective to
those who need it.
One of the most troublesome problems that our nation faces today is
drug abuse.
The spectrum of deleterious by-products of drug abuse include
rampant and often violent crime, breakdown in family life and other
fundamental social structures, and the inability of addicted
individuals to reach their full potential as contributing members of
their communities.
Unfortunately, no state or city in our great Nation is immune from
the dangers of illicit drugs.
I want children across the country to grow up drug free so that
they may realize their enormous potential.
And I want to help people across the country who are addicted to
break the grip of this deadly dependence. Our legislation focuses on
increasing the availability and effectiveness of drug treatment. The
purpose of the Drug Addiction Treatment Act of 1999 is to allow
qualifiedphysicians, as determined by the Department of Health and
Human Services, to prescribe schedule IV and V anti-addiction
medications in physicians' offices without an additional Drug
Enforcement Administration (DEA) registration if certain conditions are
met.
These conditions include certification by participating physicians
that 1) they are licensed under state law and have the training and
experience to treat persons addicted to opiates; 2) they have the
capacity to refer patients to counseling and other ancillary services;
and, 3) they will not treat more than 20 in an office setting unless
the Secretary of Health and Human Services adjusts this number.
The DATA bill provisions allow the Secretary, as appropriate, to
add to these conditions and allow the Attorney General to terminate a
physician's DEA registration if these conditions are violated. This
program will continue after three years only if the Secretary and
Attorney General determine that this new type of decentralized
treatment should not continue.
This bill would also allow the Secretary and Attorney General to
discontinue the program earlier than three years if, upon consideration
of the specified factors, they determine that early termination is
advisable.
Nothing in the waiver policy undertaken in my bill is intended to
change the rules pertaining to methadone clinics or other facilities or
practitioners that conduct drug treatment services under the dual
registration system imposed by current law.
In drafting the waiver provisions of the bill, the Drug Enforcement
Agency, the Food and Drug Administration, and the National Institute on
Drug Abuse were all consulted. As well, this initiative is consistent
with the announcement of the Director of the Office of National Drug
Control Policy, General Barry McCaffrey, of the Administration's intent
to work to decentralize methadone treatment.
In 1995, the Institute of Medicine of the National Academy of
Sciences issued a report, ``Development of Medications for Opiate and
Cocaine Addictions: Issues for the Government and Private Sector.'' The
study called for ``(d)eveloping flexible, alternative means of
controlling the dispensing of anti-addiction narcotic medications that
would avoid the `methadone model' of individually approved treatment
centers.''
The Drug Addiction Treatment Act--DATA--is exactly the kind of
policy initiative that experts have called for in America's
multifaceted response to the drug abuse epidemic. I recognize that the
DATA legislation is just one mechanism to attack his problem, and I
plan to work with my colleagues in the Congress to devise strategies to
reduce both the supply and demand for drugs.
Mr. Chairman, once again, I appreciate the opportunity to testify
before your Subcommittee today.
All of us either know, or have heard about, someone who is
struggling with drug addiction.
And drug addiction not only impacts the lives of those who are
abusing drugs, it also impacts the lives of the drug users' families
and friends.
Our legislation promotes a policy that dramatically improve these
lives because it helps those who abuse drugs to change their lives and
become productive member of society.
Let me conclude these remarks by making one quick comment relating
to the somewhat sensitive relationship of the SAMHSA and the Drug
Addiction Treatment Act, S.324. In short, I strongly favor moving both
bills this session. I would ask my good friend from Florida, Chairman
Bilirakis and my long time colleagues and partners, Chairman Bliley and
Ranking Member Dingell--two of the finest men serving in this House--
for a chance to amplify my views on this topic.
It is my understanding that it may be the case that my friend from
Michigan is upset at attempts at the end of the last Congress to
include S.324-like language into the omnibus bill.
Let my state in public that I favored such an endeavor and wrote to
the appropriators of my wishes at that time.
The DATA Bill, as Senator Levin will vouch for in a moment, has
been a bi-partisan effort in the Senate from day one. Senators Levin
and Moynihan have been with me every step of the way and we are pleased
to have been recently joined in this legislation by Senator Biden.
Our staffs' had extensive discussions with DEA and HHS, including
FDA and NIDA, last fall and were on the verge of arriving at language
that would have been acceptable to the Administration. This bill goes
exactly in the direction that General McCaffrey should be heading.
We worked closely with Mr. Bliley's office last fall as well.
To the extent that our efforts contributed to something of wholly
unintended ruckus over here in the House, I apologize.
And having said that, let me go one step further--at the risk of
infringing on the turf of my former and still beloved Labor Committee.
On Wednesday the Labor Committee reported out the SAMHSA
reauthorization bill by a 17 to 1 vote. While I have not had the
opportunity to study the reported bill in all its details, I can tell
you that as both the former Chairman of the Labor Committee and the
current Chairman of the Judiciary Committee, I have a strong interest
in the SAMHSA bill. We should all work together to pass a SAMHSA bill
this year.
I know that this is a priority of Senators Jeffords, Frist,
Kennedy, Wellstone and many other Senators, including this Senator. It
is a priority of the Administration and, I understand, the Ranking
Member of the full Committee as well.
I can only ask my friends from Florida and Virginia to give the
SAMHSA reauthorization bill the timely consideration that it deserves.
I could be wrong but my sense is that if the SAMHSA bill picked up
some steam the chances are that it might improve the climate for other
measures like S.324.
If we all work together I believe that both of these bills can pass
this year.
With regard to S.324, I think that Secretary Shalala's July 14th
letter to Representative Dingell is very instructive in many respects.
As Secretary Shalala's response states:
``In our view, to consign new treatment medications, with enhanced
safety and less diversion potential solely into the existing methadone
clinic system would be a serious public health mistake. S. 324 would
permit incremental treatment expansion to proceed in a manner which is
not overburdened by Federal, state, and local requirements as is the
case with methadone clinic regulation. This treatment expansion cannot
occur if new anti-addiction drug products are only permitted to be
dispensed through the existing methadone clinic system, because it is a
limited and closed capacity system.''
If we all work together I believe that both of these bills can pass
this year. I hope that you did not find these comments presumptions and
that you take them they way they were intended--in a spirit of mutual
cooperation and respect.
With that, Chairman Bilirakis, I leave these matters in your trusty
hands.
I look forward to working with you on moving this bill through the
legislative process.
Senator Hatch. And note that with regard with SAMHSA, it is
a priority of Senators Jeffords, Frist, Kennedy and many other
Senators, including this Senator; it is as priority in the
administration and I understand the ranking member of the full
committee as well. So I can only ask my friend from Florida, my
friend from Virginia to give the SAMHSA reauthorization bill
the consideration that it deserves.
I could be wrong, but my sense is that if the SAMHSA bill
picked up some steam, chances are it might include the climate
for other measures such as S. 324. And if we work together, I
believe that both of these bills can pass and do a lot of good.
Mr. Chairman, I want to let you know my personal esteem for
you and the leadership you provide here in the House. A lot of
good things could not happen but for your leadership and the
things that you have done in the past and are doing now. So I
just want to express my friendship and regard for you.
Mr. Bilirakis. Thank you so much, sir. You are going to
leave now, are you?
Senator Hatch. Yes.
Mr. Bilirakis. You are supportive then of the companion
measure here in the House, which is essentially similar, as I
understand?
Senator Hatch. I am.
Mr. Bilirakis. We have deferred opening statements until
after the Senators testify, Mr. Chairman. I wonder if you have
anything quick you want to ask. They have a vote taking place
over in the Senate now.
Senator Hatch. Good to see you.
Chairman Bliley. Good you to see you.
Mr. Bilirakis. Mr. Green, anything real quickly here?
Mr. Green. No, Mr. Chairman.
Mr. Bilirakis. Thank you, Senator.
Thank you very much for being here.
Mr. Bilirakis. Senator Levin.
STATEMENT OF HON. CARL LEVIN, A UNITED STATES SENATOR FROM THE
STATE OF MICHIGAN
Senator Levin. Thank you, Mr. Chairman, members of the
subcommittee. First let me tell you that we are delighted that
you are holding this hearing. We are grateful that you allow us
to go on first and quickly, even ahead of your own opening
statements. You know the kind of problem we face; you face it
every day here as well. And we are very much appreciative of
the collegiality.
Our bill and your bill will accomplish something that is
very important for this Nation. We have struggled for a long
time to find ways that we can block the craving for drugs in a
manner which will make it possible for more people to have
access to those drug blockers, as I call them, the substances
which will block the craving, the antiaddiction substances.
We spend a lot of money in our country, and properly so, on
intervention, on treatment. We have spent a lot of money trying
to see if we can't educate our young children not to ever
become open to the possibility of taking drugs. We have
recently spent some of our resources at NIH and NIDA and other
places to try to come up with substances which will block the
craving, the antiaddiction substances, and there are now a
number of those substances on the market.
One of them now is buprenorphine, and that substance is a
schedule V drug, which means it is the least subject to abuse.
It is the least addictive. And the question that we must face
and you must face is whether or not we will permit that
substance to be prescribed under very careful circumstances in
private physicians' offices, or will we follow the model that
we currently use with methadone, which requires that it be
dispensed only in a clinical setting, in a very closed-tight
clinical setting where everybody has to go to the same clinic
in order to get the prescription. Methadone is a schedule II
drug. It is highly addictive. Buprenorphine is schedule V, the
least addictive. And it is being recommended by I think just
about all of our experts that I can find that we permit this to
happen.
And so our bill, like your bill, prescribes very careful
conditions, very careful circumstances under which private
physicians in their office would be able to prescribe
buprenorphine or other schedule IV or V drugs for treatment of
drug addiction. This could be a major breakthrough. I can't
tell you how important this is from my perspective living in
two big cities, both Detroit and Washington, where we have seen
too much of the scourge of drugs. Seeing the statistics on our
young people where there is a three- or fourfold increase in
heroin addiction among our young people.
We have an opportunity here, if we do to carefully and do
it right, to strike a blow against heroin addiction. Frankly, I
can't think of anything much more important that we can do. We
are all involved in trying to get our economy both even better
than it is and keep it that way, and we debate these things
endlessly, and obviously they are worthy of debate. We are
involved in securing the Nation against any kind of peril. I am
on the Armed Services Committee in the Senate, and you folks
here in the House do the same thing. But I can't think of
anything much more important than trying to find a way to block
the craving for heroin, not just for the personal good it will
do, but for the societal and communal good it will do.The price
we pay for crime--and crime is so often drug-related--is simply
horrendous. We have an opportunity here to strike a blow
against heroin addiction.
I would simply now submit for the record a letter which
Secretary Shalala wrote to Congressman Dingell about our bill.
And I want to read just very quickly three lines from that
letter. It is a long letter, and I obviously won't read it all,
but after describing the goal that to try to reduce illicit
drug use by 50 percent by the year 2007 and to close the
treatment gap, Secretary Shalala says that one of the ways to
help address this goal is by developing new drug therapies for
the treatment of heroin addiction and she says, ``I am
especially encouraged by the results in published clinical
studies of buprenorphine.''.
She also says on page 14 of her letter that the NIDA study,
which is the pivotal efficacy and safety trial for the
buprenorphine, was performed in a nonmethadone clinic setting,
i.e., without patients, and she said the efficacy of
buprenorphine was demonstrated in this study. So the efficacy
has been demonstrated in NIDA studies.
And finally on the last page, and this to me are her most
important words, that to ``consign new treatment medications
with enhanced safety and less diversion potential solely into
the existing methadone clinic system would be a serious public
health mistake.'' S. 324, which is our numbered bill, would
permit incremental treatment expansion to proceed in a manner
which is not overburdened by Federal, State and local
requirements as is the case with methadone clinic regulation.
This treatment expansion cannot occur if new antiaddiction drug
products are only permitted to be dispensed through the
existing methadone clinic system because it is a limited and
closed-capacity system.
Mr. Chairman, I would ask that in addition to her letter,
that a letter from Professor Woods of the Department of
Pharmacology at the University of Michigan Medical School and
that a letter from the Michigan Public Health Association
supporting our bill be inserted in the record at this time.
Mr. Bilirakis. Without objection.
Senator Levin. And again, I want to thank you and your
colleagues for your courtesy, for your bill. I believe that we
can make a real difference in an area which has been very much
in need of this kind of an effort, and you have got experts in
front of you this morning that can go into the detail of why
this is a safe, efficacious and very smart, common-sense thing
to do. And again, my thanks to you.
[The prepared statement of Hon. Carl Levin, with
attachments, follows:]
Prepared Statement of Hon. Carl Levin, a U.S. Senator from the State of
Michigan
To the distinguished Chairman, Representative Bilirakis, my special
friend from Michigan, Representative John Dingell, Ranking Member of
the Commerce Committee, Representative Sherrod Brown, Ranking Member of
the Subcommittee, and other distinguished members of the Subcommittee,
I welcome this opportunity to present my views on an issue that has
been a long-term crusade of mine, speeding the development and delivery
of anti-addiction medications that block the craving illicit addictive
substances.
Mr. Chairman, I am very pleased to note the presence of witnesses
who have played, and continue to play, a very active and pivotal role
in promising new discoveries that suppress the craving for illicit
drugs. Our focus today is on a new anti-addiction medication,
Buprenorphine and Buprenorphine combined with naloxone, and how to make
this soon-to-be FDA approved medication more widely available and more
effective in treating drug abuse.
The National Institute on Drug Abuse (NIDA), in collaboration with
a private pharmaceutical company developed Buprenorphine for the
treatment of heroin addiction. I know that the experts that you have
assembled here this morning, including Dr. Charles Schuster, Director
of Wayne State's Research Division on Substance Abuse, NIDA Director
Dr. Alan Leshner, and Dr. Westley Clark, Director of the Center for
Substance Abuse will address the potential of Buprenorphine as a tool
in closing the treatment gap.
Mr. Chairman, I have joined Senator Hatch, Chairman of the
Judiciary Committee, Senator Moynihan, Ranking Member of the Finance
Committee and Senator Biden, Ranking Member of the Foreign Relations
Committee and the Judiciary Subcommittee on Youth Violence, in
sponsoring legislation [S. 324, The Drug Addiction Treatment Act] to
enable qualified physicians to prescribe schedule IV and V anti-
addiction medications in their offices, under certain strict
conditions. The goal of this legislation is to allow for Buprenorphine,
a schedule V substance under the Controlled Substances Act, to be used
in the treatment of heroin addiction in physician offices. It is my
understanding that a similar, bipartisan, bill has now been introduced
in House and I applaud this effort.
Mr. Chairman, let me take a moment to quote from a letter I
recently received from HHS Secretary Donna Shalala, and I quote: ``I am
especially encouraged by the results of published clinical studies of
Buprenorphine. Buprenorphine is a partial mu opiate receptor agonist,
in Schedule V of the Controlled Substances Act, with unique properties
which differentiate it from full agonists such as methadone or LAAM.
The pharmacology of the combination tablet consisting of Buprenorphine
and naloxone results in . . . low value and low desirability for
diversion on the street. Published clinical studies suggest that it has
very limited euphorigenic affects, and has the ability to percipitate
withdrawal in individuals who are highly dependent upon other opioids.
Thus, Buprenorphine and Buprenorphine/naloxone products are expected to
have low diversion potential. Buprenorphine and Bullrenorphine naloxone
products are expected to reach new groups of opiate addicts--for
example, those who do not have access to methadone programs, those who
are reluctant to enter methadone treatment programs, and those who are
unsuited to them (this would include for example, those in their first
year of opiates addiction or those addicted to lower doses of opiates).
Buprenorphine and Buprenorphine/naloxone products should increase the
amount of treatment capacity available and expand the range of
treatment options that can be used by physicians. Secretary Shalala
went on to say, ``Buprenorphine and Buprenorphine/Naloxone would not
replace methadone. Methadone and LAAM clinics would remain an important
part of the treatment continuum.''
Mr. Chairman, because of the reluctance of the pharmaceutical
industry to become involved in developing anti-addiction medications,
NIDA has played an active supporting research at every step of the drug
development process. NIDA's Medications Development Division has been
working to accelerate the identification, evaluation, development, and
approval of new medications to treat drug addiction, what I call anti-
addiction drugs/medications. Through this process, NIDA has been able
to bring a number of effective medications into drug treatment. In the
case of Buprenorphine products, NIDA has supported research for many
years which indicates that the medication is a useful in blocking the
craving of heroin addiction.
Dr. James H. Wood, Professor of Pharmacology at the University of
Michigan Medical School recently wrote: ``One of the most important
aspects of your bill is the use of Buprenorphine by well-trained
physicians to treat narcotic addiction from their offices, which has
the potential to attract and treat effectively, sizable populations of
currently untreated addicts . . . a major byproduct of this increased
treatment, of course, will be reduction in the demand for illicit
narcotics in the U.S. ''
Mr. Chairman, while Buprenorphine and other developments are
exciting and offer much promise for treatment, the crisis of illegal
drug use continues to cost society both in human toll and in the loss
of billions of dollars each year. Consider the startling and compelling
findings of the January 1995 Institute of Medicine Report, which
estimated the cost to society for drug abuse and dependence treatment
at $66.9 billion in 1990 alone, and estimated the cost of drug-related
crime at $46 billion that same year. A 1995 report of the Office of
National Drug Control Policy tells us that users of illegal drugs spent
$48.7 billion on the purchase of illicit substances to feed their
addiction.
Recent findings of the Monitoring the Future Program, headed by Dr.
Lloyd Johnson of the University of Michigan, indicates that heroin use
among American teens doubled between 1991 and 1998, and represents a
clear and present danger for a significant number of American young
people. Dr. Johnson attributes this ``sharp increase in use to the
administering of non-injectable modes of heroin--smoking and snorting,
in particular. Dr. Johnson goes on to say that, the very high purity of
heroin on the street has made these new developments possible and that
unfortunately, a number of those users will become dependent on heroin
and will switch over to injection, which is a more efficient way to
derive the equivalent high''
The President of the Michigan Public Health Association, Dr.
Stephanie Meyers Schim, has spoken out eloquently about the ``great
problems'' of substance abuse. In her recent letter in support of S.
324, she says: Substance abuse affects health care costs, mortality,
workers' compensation claims, reduced productivity, crime, suicide,
domestic violence, child abuse, and increases costs associated with
extra law enforcement, motor vehicle crashes, crime, and lost
productivity. Dr. Schim goes on to say, ``Buprenorphine will allow drug
addicted individuals to maximize everyday life activities, and
participate more fully in work day and family activities while seeking
the needed treatment and counseling to become drug free''.
There are yet many other compelling reasons why we must expedite
the delivery of anti-addiction medications, not the least of which are
the youth of America and the innocent victims of drug-related crime. Of
the juveniles who land behind bars in state institutions, more than 60
percent of them reported using drugs once a week or more, and over 40
percent reported being under the influence of drugs while committing
crimes, according to a report from the Bureau of Justice Statistics.
Drug-related incarcerations are up and we are building more jails
and prisons to accommodate them--more than 1000 have been built over
the past 20 years. According to the July 14, 1999 Office of National
Drug Control Policy Update, and I quote: ``Drug-related arrests are up
from 1.1 million arrests in 1988 to 1.6 million arrests in 1997--steady
increases every year since 1991.''
These sentiments were also expressed during a May 9, 1997 Drug
Forum on Anti-addiction Research, which I convened along with Senator
Moynihan, Senator Bob Kerrey and other members of the Senate. Forum
participants, including distinguished experts such as Dr. Herbert
Kleber and Dr. Donald Landry of Columbia University, Dr. Charles
Schuster of Wayne State University (who is with us today) and Dr. James
Woods of the University of Michigan, made it crystal clear that time is
of the essence--we must act expeditiously on new treatment discoveries.
The Drug Addiction Treatment Act of 1999, S. 324, focuses on
increasing the availability and effectiveness of drug treatment. The
purpose of the legislation is to allow qualified physicians to
prescribe schedule IV and V anti-addiction medications in physicians'
offices if certain strict conditions are met. These conditions include:
Certification by participating physicians that they are licensed under
state law and have the training and experience to treat heroin users;
that they have the capacity to refer patients to counseling and other
appropriate ancillary services, and that they will not treat more than
20 patients in an office-setting unless the (HHS) Secretary adjusts
this number. S. 324 also permits the Secretary, as appropriate, to add
to these conditions and allows the Attorney General to terminate a
physician's registration if the conditions are violated. The program
may be discontinued at anytime that the Secretary and the Attorney
General determine that this new type of decentralized treatment should
not continue based on a number of determinations, including: Whether
the availability of drug treatment has significantly increased without
adverse consequences to the public health and the extent to which
covered drugs may have been diverted or dispensed in violation of the
law such as exceeding the initial 20 patient per doctor limitation.
Also, states may opt out of the provision by passing legislation.
Nothing in the waiver policy undertaken in the new bill is intended
to change the rules pertaining to methadone clinics or other facilities
or practitioners that conduct drug treatment services under the dual
registration system imposed by current law. In crafting the waiver
provisions of this legislation, we consulted with the U.S. Department
of Health and Human Services, including the Federal Drug
Administration, and the Drug Enforcement Administration.
Mr. Chairman, there are a number of reasons why this legislation is
necessary. The Narcotic Addict Treatment Act of 1974, requires separate
DEA registrations for physicians who want to use approved narcotics in
drug abuse treatment and separate approvals of registrants by U.S.
Department of Health and Human Services (HHS) and by state agencies.
The result has been a treatment system consisting primarily of large
clinics, and preventing physicians from treating patients in an office
setting or in rural areas or small towns, thereby delaying treatment to
thousands in need of it. Additionally, experts say that many heroin
addicts who want treatment are often deterred because of the stigma
that is associated with such clinics.
The intent of our legislation is to make possible for medications
like Buprenorphine, where no likelihood of diversion or abuse or
addiction or abuse of such drug to be used effectively to block the
craving for heroin. To do this, you must need to make it available in a
physician office, and to make sure that such availability is not
abused. These protections include the following: Physicians may not
treat more than 20 patients in an office setting unless the HHS
Secretary adjusts this number; the HHS Secretary, as appropriate, may
add to these conditions and allow the Attorney General to terminate a
physician's DEA registration if these conditions are violated; and the
program will continue after three years only if the HHS Secretary and
Attorney General determine that this new type of decentralized
treatment should continue based on a number of determinations. And
again, States can opt out of the provision.
In closing, the American Society of Addiction Medicine (ASAM) and
the College on Problems of Drug Dependence, tie nation's longest
standing organization of scientists addressing drug dependence and drug
abuse, states that the availability of Buprenorphine in physicians'
offices adds a needed expansion of current treatment for heroin
addiction. ASAM also cautioned that Buprenorphine will have limited
utility if it is tied to the regulatory structure for current
treatments of heroin addiction.
Mr. Chairman, thank you for inviting me here today.
______
Department of Health and Human Services
July 14, 1999
The Honorable John D. Dingell
Ranking Member
Committee on Commerce
House of Representatives
Washington D. C. 20515
Dear Mr. Dingell: Thank you for your recent letter requesting
information about increasing the availability and effectiveness of drug
addiction treatment. We are particularly pleased with your interest in
the development of buprenorphine and buprenorphine combined with
naloxone (buprenorphine/nx) products as treatments for heroin (and
other opiate) addiction.
Increasing access to treatment and reducing the morbidity,
mortality, and cost to society associated with addiction is part of the
Administration's overall demand reduction strategy articulated in the
National Drug Control Strategy 1999. The Department of Health and Human
Services has a major role to play in the strategy's plan to reduce
illicit drug use by 50 percent by the year 2007 and to close the
``treatment gap.'' One of the ways to help address this goal is by
developing new drug therapies for the treatment of heroin addiction. I
am especially encouraged by the results of published clinical studies
of buprenorphine.
I would note that as of the date of this response, neither
buprenorphine nor the combination drug has been approved by the FDA.
Also, while Senator Hatch has introduced S. 324, the bill referenced in
this letter, no comparable bill has been introduced in the House.
I would like to provide a quick overview of buprenorphine and
buprenorphine/nx to frame the answers to the questions you have posed.
Buprenorphine is a partial mu opiate receptor agonist
(currently in Schedule V of the Controlled Substances Act) with
unique properties which differentiate it from full agonists
such as methadone or levomethadyl acetate (LAAM).
The pharmacology of the combination tablet consisting of
buprenorphine and naloxone results in subjective effects which
are believed to provide low value and low desirability for
diversion on the street. Published clinical studies suggest
that it has very limited euphorigenic effects, and has the
ability to precipitate withdrawal in individuals who are highly
dependent upon other opioids. Thus, buprenorphine and
buprenorphine/nx products are expected to have low diversion
potential.
Buprenorphine and buprenorphine/nx products are expected to
reach new groups of opiate addicts--for example, those who do
not have access to methadone programs, those who are reluctant
to enter methadone treatment programs, and those who are
unsuited to them (this would include for example, those in
their first year of opiate addiction or those addicted to lower
doses of opiates).
Buprenorphine and buprenorphine/nx products should increase
the amount of treatment capacity available and expand the range
of treatment options that can be used by physicians.
Buprenorphine and buprenorphine/nx would not replace
methadone. Methadone and LAAM clinics would remain an important
part of the treatment continuum. In fact, clinics are likely to
receive referrals for patients who do not do well on
buprenorphine and buprenorphine/nx or who need specialized
services provided in clinics, and clinics may wish to move some
of their patients to buprenorphine and buprenorphine/nx, either
for maintenance or detoxification. This could mean that
methadone clinics could admit additional patients, currently on
waiting lists, for whom methadone or LAAM is the most
appropriate treatment choice.
I am pleased to provide you with the enclosure that answers your
specific questions. Thank you again for your interest in broadening
access to treatment.
Sincerely,
Donna E. Shalala
Secretary
1. Would the implementation and administration of S. 324 require
the expenditure of resources by any agency of the federal government?
If so, which ones? Can you estimate the amount of resources needed to
implement S. 324 and whether the bill provides adequate authorization
of appropriations for these purposes? What existing programs and
activities would be affected if this legislation was enacted without a
specific provision of resources for its implementation?
To implement S. 324, additional resources would be required by the
Substance Abuse and Mental Health Services Administration (SAMHSA),
Center for Substance Abuse Treatment (CSAT). Resources would be
required to process provider applications and assess provider
qualifications, make a determination of adverse use, provide
information to the Attorney General, make determinations regarding
waivers, and collect data and evaluate the impact of the program.
It is difficult to estimate the resources necessary to carry out
the program. We make the assumption that as many as 6,000 physicians
(about one percent of the physicians in the U.S. ) may seek a waiver
under this provision. The bill currently specifies that practitioners
must be physicians. If other practitioners such as nurse practitioners,
who are licensed in many states and have made great contributions to
drug abuse treatment, were to be included, then additional costs would
have to be taken into account. In addition, the costs of administering
the program will increase as new drugs are approved by FDA for the
treatment of opioid addiction and would be subject to the provisions of
this bill.
At this time we estimate that CSAT would require approximately $4
million in the program management costs to implement the program in the
first year. As written, S. 324 does not provide the appropriations
authority for these requirements.
If resources were not made available to SAMHSA to establish and
provide oversight of this new office-based practice system, the agency
would have to shift programmatic funds from other intended uses. It
would not be possible at this time to identify specific programs or
activities that would be adversely affected.
2. Please describe the problem of heroin addiction in terms of
factors considered by you to be relevant to the development of public
health policy for its treatment. We know that many heroin addicts do
not receive treatment for a variety of reasons. Please comment on the
extent to which S. 324 is responsive to addressing the needs of those
heroin addicts who do not currently receive treatment. More detailed
questions follow on issues affecting the utility of this bill to heroin
addicts in terms of economic status, severity of addiction, use of
other substances, and age. Please do not limit your response to these
areas. I would like to know of all limitations on access to
buprenorphine in non-clinical settings that may exist and that are not
addressed in this legislation. Does the bill, for example, provide
financial resources for those who cannot afford access to addiction
treatment services in non-clinical settings described in the
legislation?
The Problem
The heroin abusing population has grown larger and younger during
the 1990's. Data from the 1997 National Household Survey on Drug Abuse
(NHSDA) indicates that heroin abuse in the household population age 12
and older, rose dramatically from 71,000 in 1991 to 325,000 in 1996.
These estimates may be conservative in that the NHSDA relies on self-
reported drug use. The NHSDA also showed an increase in heroin use
among youth ages 12 to 17 and 18 to 25.
Many individuals who want effective treatment for their addiction
do not have access to it. National estimates of the number of patients
in methadone or LAAM treatment increased from over 81,000 in 1987 to
95,000 in 1991, and with a current estimate of 180,000 in 1998.
However, the Office of National Drug Control Policy (ONDCP) estimates
that there are about 810,000 heroin addicts in the United States. Eight
states do not have any methadone maintenance treatment services. In
many other states access to this treatment is severely limited by
restrictive community zoning practices, inadequate public funding,
inadequate commercial health plan benefits and coverage, and other
restrictive policies and practices. Current federal and state
regulations prevent ease of entry into methadone/LAMM maintenance
treatment during the first year of heroin/opiate use. Although short
term detoxification treatment using methadone is available under
federal regulations (without a one year history of dependence), it is
during this first year that new injectors are most likely to be exposed
to infectious diseases such as HIV, hepatitis and sexually transmitted
diseases. Thus, by the time most younger addicts would have access to
maintenance treatment, they already may have contracted infectious
diseases which might have been prevented. The use of oral medications
(such as methadone) has been shown to reduce the incidence of
infectious diseases among opiate addicts.
Existing Anti-addiction Medications Are Stigmatized
S. 324 would increase access to treatment by making available
office-based treatment to heroin addicts who are appropriate candidates
for new pharmacotherapy treatment. Many heroin addicts who do have
access to methadone or LAAM treatment continue to avoid treatment
because of either the stigma of being in methadone treatment or their
concerns about the medical effects of these medications. The stigma and
prejudice against patients in methadone treatment comes not only from
the fear that they may be denied access to certain jobs, child custody
or even medical care, but also from the prejudice within the greater
community, where they are likely to be labeled as weak and as ``trading
one addiction for another.''
Withdrawal
Newer treatment drugs that have less protracted withdrawal
characteristics may address with an important physical disincentive
that keeps patients away from methadone treatment. Patients have a fear
of severe and/or protracted symptoms during withdrawal from methadone.
While withdrawal from methadone generally causes milder symptomatology
than heroin withdrawal, the syndrome does last a considerably longer
period. Withdrawal from medications currently under study, e.g.
buprenorphine and buprenorphine/nx, are both milder than from heroin
and shorter than from methadone. In research situations it has been
shown to be significantly easier, both for the patient and for the
health professional, to manage withdrawal.
Increasing Treatment Access
S. 324 promotes the office-based use of Schedule IV and V
medications to treat opioid addiction. National estimates suggest only
22 percent of opioid addicts are now receiving effective
pharmacotherapy (methadone or LAAM) for their addiction. There are only
a handful of physicians currently approved by the FDA to use methadone
or LAAM to treat heroin addicted patients in their private practice.
One expected result of S. 324 is that the number of physicians in
private practice who are likely to treat this population with new anti-
addiction medications, e.g. buprenorphine/nx, if approved by the FDA,
is likely to increase considerably. The bill does not provide
appropriations authorization to pay for treatment for those who are
uninsured and cannot afford the cost of the treatment. These economic
access issues are not addressed.
3. Have buprenorphine or buprenorphine/naloxone been approved by
the FDA for any purpose other than the treatment of heroin addiction?
Have these products been approved by FDA for the treatment of heroin
addiction? Please comment on whether it is prudent or precedented for
HHS to support legislation such as S. 324 in the absence of FDA
approval for these products. Who is the product sponsor? Would S. 324
apply to any products other than buprenorphine or buprenorphine/nx?
Neither buprenorphine nor buprenorphine/naloxone is an approved
drug in the U.S. for treating heroin addiction. An injectable
formulation of buprenorphine hydrochloride is approved by the FDA for
use as an analgesic. The new drug application holder is Reckitt and
Colman. The trade name for the Reckitt and Colman product is Buprenex.
There also is a generic version of the injectable product made by
Abbott. The injectable formulation is not approved for use in addiction
treatment, and thus is not covered under the bill. Naloxone is marketed
by DuPont Pharma and various generic companies.
S. 324 would not apply at this time to any approved product. It
would apply to buprenorphine and buprenorphine/nx, if approved, and to
any other narcotic drugs or combination of drugs in schedule IV or V
which are approved for use in maintenance or detoxification treatment,
if certain other conditions are met.
4. According to information provided to my staff by SAMHSA, a
majority of heroin addicts use or abuse as many as eight other drugs.
Does buprenorphine, for example, interact with other substances
commonly used by heroin addicts? Please comment on the extent to which
these factors may limit the utility of buprenorphine for treating
heroin addiction. Are these issues addressed in any clinical trials
that have been or will be conducted for buprenorphine? Can these
questions be properly answered other than in the context of final FDA
approval of these products for heroin addiction treatment? The National
Institute on Drug Abuse opined in writing last year that buprenorphine
was safe and effective for the treatment of heroin addiction. Please
comment. What is the basis for NIDA giving such an opinion? What
effect, if any will NIDA's opinion on safety and efficacy have on FDA's
process for evaluating the safety and efficacy of buprenorphine and
buprenorphine/nx for heroin addiction?
It is true that many addicts may abuse more than one substance at a
time. Treatment personnel must try to identify the substances being
abused and work with the patient to recommend the treatment modalities
that best meet the needs of that individual. Because addiction to
several substances is so common in this population, the interaction of
buprenorphine with other substances commonly used by heroin addicts has
been studied both in clinical trials (where research subjects provide
urine samples which are analyzed for metabolites of drugs of abuse and
where clinical staff observe and take case histories) and by
preclinical interaction studies undertaken in animals. It is a well-
known pharmacological fact that all opiate drugs, including
buprenorphine, may have serious reactions (respiratory depression) if
co-injected with benzodiazepines, so all research subjects are warned
of this fact, and it will be included in the product labeling. This
interaction has been known for years and is in the Buprenex
(injectable) product labeling. No other serious adverse reactions have
been noted by investigators to date in the clinical studies with other
drugs of abuse or concurrent medications taken by individuals. This
information will be reviewed by FDA in approving/disapproving
buprenorphine for its intended indication. As with any medication
reviewed by the FDA, the FDA must approve specific labeling and package
insert material which will adequately describe for physicians potential
drug interactions, precautions, and dosing recommendations.
The National Institute on Drug Abuse has relied on published data
from multiple studies evaluating buprenorphine given as a sublingual
solution or tablets, in the treatment of heroin addiction to conclude
that buprenorphine was safe and effective. In addition, FDA had issued
an ``approvable'' letter (NDA 20-732, June 30, 1998) concerning the
noncombination version of buprenorphine tablets based on the data
submitted and evaluated to date. Specific issues related to the
proposed formulation need to be resolved before the product can be
approved for marketing.
Additionally, in a clinical study (NIDAIVA #1008, a Multi-center
Efficacy/Safety Trial of Buprenorphine/Naloxone for the Treatment of
Opiate Dependence), the Data Safety Monitoring Board performed an
interim data analysis and found that buprenorphine/nx was so clearly
superior to placebo that it recommended that the placebo arm of the
study be terminated and that buprenorphine be made available to all
research subjects in the trial. NIDA provided this information to
Senator Carl Levin, at his specific request, and recognizes that it
does not affect the FDA's final deliberations or jurisdiction in this
matter. Rather, it was meant to provide Congress, states, and the
treatment community advance knowledge about the existence of a new
potential treatment which could significantly expand the numbers of
persons in treatment.
The possibility of expanding treatment for this population is
critically important. Currently, eight states do not have any programs
or clinics providing methadone, and many of the approximately 630,000
persons in need of treatment (the Office of National Drug Control
Policy currently estimates the number of weekly heroin users at
810,000) would benefit from expansion beyond the current methadone
clinic system, which currently serves only about 180,000 clients. As a
public health matter, each person who continues to inject heroin is at
high risk of contracting and spreading infectious diseases such as HIV,
hepatitis, and tuberculosis. We believe, as does the Institute of
Medicine (see Federal Regulation of Methadone Treatment; National
Academy Press, Washington, D.C. 1995, which is provided under a
separate cover) that the multiple layers of Federal, state, and local
regulation of the current methadone clinic system have hampered
treatment expansion. Because buprenorphine and buprenorphine/nx have
unique pharmacologic qualities, we are hopeful that these will offer
states an opportunity to expand treatment in a manner currently not
available under the methadone clinic system.
FDA's process for evaluating the safety and efficacy of
buprenorphine and buprenorphine/nx for heroin addiction is based on a
careful analysis of the results of controlled clinical trials which is
independent of NIDA's opinion on this issue. Any information or data
provided by NIDA, on this or any other application, will be evaluated
with the same scientific review accorded data from any other source and
contained within the submissions to the FDA.
5. Methadone is the predominant drug used in programs for treatment
of heroin addiction and requires daily dosing combined with counseling
and other treatment services. Recently Barry McCaffrey, the White House
Office of Drug Policy Director, indicated that methadone should be
considered for non-clinical settings. Should methadone be administered
in non-clinical settings? If not, what is the basis for distinguishing
methadone and buprenorphine in this manner?
HHS's position is that methadone can be administered in non-clinic
settings as a long-term maintenance therapy to patients who have been
medically and clinically determined to be in stable recovery. This
treatment has been provided successfully on a small experimental basis
for some years and is also being implemented in a community in
Connecticut with CSAT support and technical assistance. CSAT is now
developing practice guidelines to help physicians, patients, and
treatment programs better understand how to deliver this service to
this select group of patients.
Because some of the pharmacologic characteristics of methadone,
buprenorphine and buprenorphine/nx are different, the treatment
standards for their use will likely reflect those differences. For
example, buprenorphine and buprenorphine/nx appear to be considerably
easier to withdraw from than methadone and appears to engender a much
lower level of physical dependence. Therefore, induction onto
buprenorphine products will not necessarily be seen as having the long-
term implications associated with methadone. SAMHSA is currently
working with the FDA to revise the treatment standards for methadone
and to propose treatment standards for buprenorphine and buprenorphine/
nx, if approved by FDA for this purpose.
6. Is buprenorphine expected to be effective for all heroin
addicts? Can you estimate the number of persons for whom buprenorphine
is not expected to be effective due to the nature and severity of their
addiction?
Buprenorphine and buprenorphine/nx, if approved, may not be
effective for all heroin addicts. No medication for any brain disorder
claims a 100% response rate. As with any medication, some persons will
respond better than others. Clinical experience to date indicates that
those persons with the highest tolerance levels for opiates may find
that a full opiate agonist medication (such as methadone or LAAM) may
be preferable. NIDA estimates that approximately 20-25% of the
approximately 630,000 heroin addicts in need of treatment may be
treated with buprenorphine and buprenorphine/nx. This is due to many
factors, among which are the nature and severity of their addiction.
Additionally, there may be no reason for those patients whose opiate
dependence is well managed by taking methadone or LAAM to be switched
to any other medication. This is an individual physician/patient
decision. As in all forms of medicine, it is critically important to
allow physicians and patients to have access to as many forms of
treatment as may be available, and to choose the best match for each
individual.
7. FDA predominantly requires double blind placebo trials to test
new drugs. Have clinical trials been conducted that directly compare
the safety and efficacy of buprenorphine and methadone?
FDA requires adequate and well-controlled trials, but placebo is
not the only acceptable type of control. Active controls and dose
controls are frequently used. Several published studies of a different
formulation of buprenorphine used methadone as an active control.
However, these were not designed to compare the efficacy of the two
therapies. We know of no studies that would support a comparative
efficacy claim for buprenorphine sublingual tablet or buprenorphine/nx
sublingual tablet versus methadone. Of note, FDA does not necessarily
require that a new therapy demonstrate superiority to existing
therapies in order to gain approval for marketing.
8. Heroin use has doubled among teenagers in the 1990's. Under many
methadone treatment programs, a heroin addict under the age of 18 years
must have parental consent in order to receive treatment. Will access
to buprenorphine be limited to persons in the same manner as methadone?
If access to buprenorphine will not be limited on the basis of age,
what is the rationale for an age limitation for access to methadone in
a clinical setting, but not for buprenorphine in a non-clinical
setting? Could you also address the issue of youth heroin addiction in
terms of income and severity of addiction as these affect teen access
to buprenorphine in non-clinical settings?
You have correctly identified a major public health problem. The
fact that heroin use has increased dramatically (almost five-fold)
among teenagers in the 1990's is of grave concern to the Department. We
plan to address this problem at many levels, including increasing our
prevention efforts, as well as increasing the range of treatment
options available to adolescents. We speculate that the anticipated
availability of partial agonist medications such as buprenorphine and
buprenorphine/nx could significantly help toward this end. The general
scientific assessment, based on clinical pharmacology studies, is that
the partial agonist quality of buprenorphine and buprenorphine/nx is
associated with two important pharmacological properties: a ceiling
effect on respiration imparting a lessened risk of fatal overdoses, and
milder withdrawal than full agonist medications. Thus, buprenorphine
and buprenorphine/nx may be appropriate for short-term treatment in
adolescents, utilizing the anticipated effect of milder withdrawal to
ease individuals off these products with what NIDA believes will be
relative ease.
In fact, NIDA is about to commence a study of buprenorphine/nx in
``office-based'' settings. One of the stated objectives of this study
is to evaluate buprenorphine/nx in the treatment of the adolescent
opiate dependent population aged 15 or older. The protocol provides for
assessments for both short-term and longer-term (up to one year) use of
buprenorphine/nx in the treatment of opiate addiction. Data from this
study could be used to inform the development of practice guidelines
for the use of buprenorphine/nx in adolescent addicts, or to augment
regulations promulgated by the Department.
Access to methadone treatment by adolescents is currently
restricted by FDA regulations. These regulations (21 CFR part
291.505(d)(1)(iv)) specify that adolescents under 18 must have had two
documented attempts at short-term detoxification or drug-free treatment
to be eligible for maintenance treatment. We cannot comment at this
time whether similar restrictions would be placed on buprenorphine and
buprenorphine/nx treatment. However, it is unlikely that the treatment
setting would matter if an age limitation were imposed on buprenorphine
products for the treatment of narcotic addiction.
Access by teenagers to buprenorphine and buprenorphine/nx treatment
in ``office-based'' practices will most likely depend on the patient's
ability to pay for treatment services, either through coverage under a
parent's private health insurance, through Medicaid, or out of pocket.
Across all states, only about 35 percent of persons below age 19 are
covered as dependents under any type of employer coverage. Medicaid
coverage across all states for youth below age 19 is about 38 percent.
This means over a quarter of all youths who may need substance abuse
treatment have no ability to get it. In addition, many commercial
insurance plans and State Medicaid plans specifically exclude or limit
benefits for substance abuse treatment under managed care arrangements.
Most often, benefits for substance abuse treatment are restricted to
detoxification and very limited outpatient counseling services.
9. Please provide an estimate of the expected per dose costs of
buprenorphine and methadone. Please include a comparison of the costs
of methadone and buprenorphine in terms of the number of doses and
duration of treatment in similar cases. Will federal health care or
substance abuse treatment funds be available to heroin addicts who want
to receive buprenorphine in non-clinical settings? If so, please
identify their source and state whether these resources are expected to
be adequate in view of the number of and economic status of persons who
may wish to have access to buprenorphine in non-clinical settings.
The drug sponsor has not provided the agency with data on cost per
dose and we have no way of estimating them or making comparisons with
the cost of methadone at this time. The cost per dose of methadone is
approximately $1.50 per day and $10 per day for treatment. Methadone is
one of the cheapest of all pharmaceutical products for opiate addiction
due to its ease of synthesis and its availability since the 1960s. The
Department has not requested funds targeted to pay for administration
of buprenorphine and buprenorphine/nx in non-clinic settings in the FY
2000 budget.
Substance abuse and prevention and treatment block grant funding
are limited to public and nonprofit private entities. The states
generally allocate these funds to community-based treatment providers,
not to individual health care practitioners.
Other Federal health care or substance abuse funds, e.g., the
Department of Veterans Affairs or the Medicaid program, may be
available for this population based on eligibility criteria and other
factors. Currently, under Medicaid, substance abuse treatment is a
state option, not a required service. About half of all states do not
include benefits for methadone treatment in their Medicaid program.
Based on this we can anticipate that coverage for buprenorphine and
buprenorphine/nx would be minimal. There are also few benefits for
substance abuse treatment under the State Children's Health Insurance
Programs (CHIPS). Additionally, treatment funds may be available to
treat heroin addicts with buprenorphine and buprenorphine/nx through
other HHS agencies, e.g., Indian Health Service and the Health
Resources and Services Administration's Bureau of Primary Health Care.
10. Buprenorphine has been given orphan drug status. Because the
number of heroin addicts is estimated to exceed 200,000 persons, was
the determination of orphan status dependent upon the product sponsor's
cost of developing this product? Can you please provide us with the
factual basis upon which the decision to grant orphan status was made?
What are the total expected number of years of patent and market
exclusivity the product sponsor can expect for buprenorphine and
buprenorphine/nx? Does this status preclude competition from
bioequivalent products during that time?
The determination and grant of orphan drug status for buprenorphine
and buprenorphine/nx was based upon economic data projected by the
sponsor on the costs of research and development for the designated
indication. Information from NIDA on its CRADA (Cooperative Research
and Development Agreement) with the sponsor, and other public
information on the systems and facilities for treatment of narcotic
addiction, as well as projections of the market potential for the
product were considered in the determination. All data were calculated
as of the date of the orphan designation application.
The factual basis on which this decision was made was information
provided by the sponsor. The information in the designation application
is not disclosed prior to market approval. After market approval,
disclosure excludes financial information and other confidential
information submitted. The sponsor has not made the information public
and has indicated to FDA that it wishes such information to be kept
confidential as commercial confidential information.
Until a product is approved, it is not possible to determine the
remaining patent exclusivity on a particular product. If the product is
approved, orphan product designation will provide market exclusivity of
seven years.
With respect to market exclusivity and preclusion of competition
from bioequivalent products, the provisions of 21 U.S. C. Sec. 360cc
provide as follows:
``(a) Except as provided in subsection (b), if the Secretary--
(1) approves an application filed pursuant to section 505(b),
(2) issues a license under section 351 of the Public Health
Service Act for a drug designated under section 526 for a rare
disease or condition, the Secretary may not approve another
application under section 505 or issue another license under
section 351 of the Public Health Service Act for such drug for
such disease or condition for a person who is not the holder of
such approved application, of such certification, or of such
license until the expiration seven years from the date of the
approval of the approved application, the issuance of the
certification or the issuance of the license. Section 505(c)(2)
does not apply to the refusal to approve an application under
the preceding sentence.
(b) If an application filed pursuant to section 505(b) is approved
for a drug designated under section 526 for a rare disease or
condition, if a certification is issued under section 507 for such
a drug or if a license is issued under section 351 of the Public
Health Service Act for such a drug, the Secretary may, during the
seven-year period beginning on the date of the application
approval, of the issuance of the certification under section 507,
or of the issuance of the license, approve another application
under section 505(b), issue another certification under section
507, or, issue a license under section 351 of the Public Health
Service Act, for such drug for such disease or condition for a
person who is not the holder of such approved application, of such
certification, or of such license if--
(1) the Secretary finds, after providing the holder notice and
opportunity for the submission of views, that in such period
the holder of the approved application, of the certification,
or of the license cannot assure the availability of sufficient
quantities of the drug to meet the needs of persons with the
disease or condition for which the drug was designated; or
(2) such holder provides the Secretary in writing the consent of
such holder for the approval of other applications, issuance of
other certifications, or the issuance of other licenses before
the expiration of such seven-year period.''
(Note: The phrases ``of such certification'' and ``the issuance of the
certification'' are probably meant to be deleted as section 125 of Pub.
L. 105-115 repealed sections 506 and 507.)
11. Buprenorphine was developed under a Cooperative Research and
Development Agreement with NIDA. Can you provide a narrative
description of this agreement, specifically including the terms and
conditions agreed to by the product sponsor and the NIDA? How much
money has NIDA spent under the terms of this agreement? In what manner,
if any, was the federal share of the costs of development included by
the product sponsor in the grant of orphan status? Were the sponsor's
costs of developing buprenorphine for any other purpose than heroin
addiction included in any way in the determination of development
costs?
Buprenorphine and buprenorphine combined with naloxone are being
developed under a Cooperative Research and Development Agreement
(CRADA) between NIDA and Reckitt & Colman Pharmaceuticals, Inc. The
terms and conditions of the CRADA specified that Reckitt & Colman would
collaborate in the development of buprenorphine and buprenorphine
combined with naloxone. Reckitt & Colman was required to produce all
dosage forms, collaborate on the design of clinical trials and
participate in joint analysis of clinical trial data, permit
investigators to publish the results of their studies, produce New Drug
Application (NDA) reports as required by the FDA, and file NDAs as
warranted by the study results.
NIDA's role was to provide access to a clinical trials network
suitable for undertaking trials acceptable to the FDA under its Good
Clinical Practices Guidelines, monitoring the trials and reporting
adverse events to the FDA, to participate in meetings with
investigators and the FDA, and to participate as appropriate in
publications resulting from the studies. Under the terms of a CRADA, no
federal funds are provided to the outside collaborator.
NIDA estimates that it provided in kind services (clinical
pharmacology, analytical resources, and clinical trial support) related
to the development of the buprenorphine products of approximately $26
million over a five year period, or about $5 million per year. It is
important to note that the pharmaceutical industry estimates the cost
of bringing a new medication to market at approximately $500 million
(source: Pharmaceutical Research and Manufacturers Association).
Therefore, the expenditure of these funds, in pursuit of an orphan
medication, and in view of the fact that two new dosage forms were
developed and tested to potential NDA status is very reasonable. It is
also important to note that without the support of Reckitt & Colman,
the cost to the Federal Government would have been substantially
higher.
NIDA was pleased to have Reckitt & Colman as the sponsor in the
development and marketing of these products, especially given the
reluctance of pharmaceutical companies to invest in the development of
pharmacotherapies for drug abuse and addiction. This is mainly due to
the lack of market incentives and the societal stigma that companies
perceive can be created if one of their products is approved for use in
the treatment of drug abuse and addiction. This reluctance by the
private sector to develop anti-addiction medications is the main reason
why NIDA's medications development program was created by Congress in
1988 (P.L. 100-690 and P.L. 102-321). (For a full analysis of factors
discouraging industry, see The Development of Medications for the
Treatment of Opiate and Cocaine Addictions: Issues for the Government
and Private Sector; National Academy Press, Washington, D.C., 1995. A
copy is being forwarded under separate cover.)
12. Buprenorphine is intended to treat heroin addiction. Can you
provide an analysis of all addictions that lead to an increase in
morbidity and mortality in the United States? Please include
information available to you regarding trends, socioeconomic status,
race and ethnic factors, and other measures used by public health
officials to assess and evaluate public health issues and public policy
responses to them. Vice President Gore recently was the keynote speaker
at a NIDA sponsored National Research Forum. He is quoted in ``NIDA
Notes'' as saying that ``nicotine is a drug--a dangerous, highly
addictive drug, and we should treat it as a drug . . . nicotine is a
highly addictive drug--as addictive as heroin or cocaine.'' Your
analysis should specifically include nicotine. Does S. 324 address any
of these other addictions?
Extensive information on various addictions in the U.S. population
is provided as an attachment to this letter.
FDA has provided a comprehensive discussion of nicotine addiction
in its Nicotine Regulation Documents. These include references to the
available literature and FDA's concerns with nicotine addiction,
particularly in children. These documents are too voluminous to be
replicated in this letter, however, they are readily available on FDA's
Web site. The web site address is www.fda.gov. Once that site is
accessed simply click on the icon ``Children & Tobacco: Regulations &
Information.'' The available documents include ``Tobacco Regulations
and Related Federal Register Documents'' which contain the information
referred to above.
The language provided in S. 324 is that the provisions would apply
to any narcotic drugs or combination of drugs in schedule IV or V which
are approved for use in maintenance or detoxification treatment, if
certain other conditions are met. The terms ``maintenance treatment''
and ``detoxification treatment'' are defined in the Controlled
Substances Act. Sections 102 (29) and (30) (21 U.S. C. Sec. 802) define
these terms. Since S. 324 would amend the Controlled Substances Act,
these definitions would be applicable.
13. Does the Administration have an effort under way to study and
demonstrate the use of anti-addictive medicines, particularly
buprenorphine, in non-clinical settings? Please describe this activity
and indicate what impact, if any, S. 324 would have on the substance
and timing of this effort. Please describe in terms of efficacy,
diversion, and other relevant health and safety considerations the
differences between the administrative program already under way and
the program contemplated by S. 324. In view of your existing
administrative efforts, is legislation needed?
The NIDA-VA study 1008, the pivotal efficacy and safety trial for
the buprenorphine and buprenorphine/nx tablets, was performed in a non-
methadone clinic setting (i.e., outpatients in VA medical centers). The
efficacy of buprenorphine and buprenorphine/nx was demonstrated in this
study. Additionally, O'Connor et al (attached) evaluated buprenorphine
in a primary care medical setting versus a traditional methadone
clinic.
Expanding on this, NIDA intends to undertake a study of
buprenorphine/nx in a variety of non-clinic settings to gather
information on the use of this medication in special populations, such
as adolescents. Although the proposed study is not required for the
basic NDA and is riot relevant to the safety and efficacy data required
for approval of the product, it may provide additional information to
FDA that may be helpful in development of recommended labeling for the
product. It will also provide Public Health Service agencies the
opportunity to evaluate physician-training materials. Not only will
this study provide valuable information, but it will be in compliance
with a Congressional mandate that all National Institutes of Health
research studies include children and adolescents when relevant and
feasible. Additionally, the study report could be presented as part of
the data package from the Office of the Secretary, HHS in determining
whether buprenorphine treatments have been effective forms of
maintenance and detoxification as called for in S. 324.
The enactment of S. 324 would have no impact on this study. S. 324
would permit the introduction of buprenorphine and buprenorphine/nx, if
approved by the FDA, in a limited and controlled manner, to settings
other than traditional methadone clinics. It is widely recognized (see
Federal Regulation of Methadone Treatment; National Academy Press,
Washington, D.C. 1995) that meaningful further expansion of the present
methadone clinic system is not probable under the current weight of
Federal, state, and local regulations. The experience with the
introduction of LAAM, an orphan product approved in 1993, into this
clinic system is highly instructive. It took the majority of States
three years beyond Federal approval to approve the use of LAAM in their
clinic systems. Moreover, each clinic needed to be registered on an
individual basis. Only one fourth of the extant narcotic treatment
programs have ordered LAAM. Because all treatment with methadone and
LAAM must be provided through these clinics, virtually no expansion of
treatment has occurred. In other words, the same 180,000 clients per
year are receiving either methadone or LAAM (of which approximately
5,000 are LAAM patients). As a public health matter, the limited number
of methadone clinics in this country is the rate limiting factor in
providing additional pharmacological treatment for heroin addiction.
This is occurring at a time when, as you note, heroin use is rising,
and the burden of infectious diseases such as HIV, hepatitis, and
tuberculosis is rising concurrently.
Because buprenorphine combined with naloxone will be the product
utilized in outpatient treatment, its diversion potential is expected
to be much lower than that of either methadone or LAAM. The Drug
Enforcement Administration has recognized as much. A copy of the letter
of July 14, 1998, from Thomas A. Constantine, Administrator, Drug
Enforcement Administration, to the Honorable Bill McCollum concerning
its views on this matter is forwarded with these comments.
In our view, to consign new treatment medications, with enhanced
safety and less diversion potential solely into the existing methadone
clinic system would be a serious public health mistake. S. 324 would
permit incremental treatment expansion to proceed in a manner which is
not overburdened by Federal, state, and local requirements as is the
case with methadone clinic regulation. This treatment expansion cannot
occur if new anti-addiction drug products are only permitted to be
dispensed through the existing methadone clinic system, because it is a
limited and closed capacity system.
It is important to point out that buprenorphine or buprenorphine/nx
is not expected to replace methadone. In fact, methadone and LAAM
clinics would remain an important part of the treatment system. Clinics
are likely to receive referrals for patients who do not do well on
buprenorphine and buprenorphine/nx or who need specialized services
provided in clinics; and clinics may wish to move some of their
patients to buprenorphine and buprenorphine/nx, either for maintenance
or detoxification. This could mean that methadone clinics could admit
additional patients, currently on waiting lists, for whom methadone or
LAAM is the most appropriate treatment choice.
Question 12:
Buprenorphine is intended to treat heroin addiction. Can you
provide an analysis of all addictions that lead to an increase in
morbidity and mortality in the United States? Please include
information available to you regarding trends, socioeconomic status,
race and ethnic factors, and other measures used by public health
officials to assess and evaluate public health issues and public policy
responses to them. Vice President Gore recently was the keynote speaker
at a NIDA sponsored National Research Forum. He is quoted in ``Nida
Notes'' as saying that ``nicotine is a drug--a dangerous, highly
addictive drug, and we should treat as a drug . . . nicotine is a
highly addictive drug--as addictive as heroin or cocaine.'' Your
analysis should specifically include nicotine. Does S. 324 address any
of these other addictions?
Answer:
According to a special study of causes of death in 1990, tobacco
accounted for 38 percent, the greatest proportion of preventable deaths
in the United States. (McGinnis & Foege. ``Actual Causes of Death in
the United States.'' Journal of the American Medical Association
270(18):2207-2212. The others are listed below:
Actual Causes of Preventable Deaths in the United States
------------------------------------------------------------------------
Estimated Percentage
Cause Number of Total
------------------------------------------------------------------------
Total......................................... 1,060,000 100
Tobacco....................................... 400,000 37.7
Diet/Activity Patterns........................ 300,000 28.3
Alcohol....................................... 100,000 9.4
Toxic agents.................................. 90,000 8.5
Mcrobial agents............................... 60,000 5.7
Firearms...................................... 35,000 3.3
Sexual Behavior............................... 309000 2.8
Motor Vehicles................................ 25,000 2.4
Illicit use of drugs.......................... 20,000 1.9
------------------------------------------------------------------------
With regard to the use of alcohol, cigarettes and other drugs for
the U.S. population age 12 and older:
Prevalence of Past-Month Alcohol, Cigarette, and Other Drug Use U.S.
Population, Age 12 and Older, 1997*
------------------------------------------------------------------------
Number
Substance Using Percent
(1,000s) Using
------------------------------------------------------------------------
Alcohol....................................... 111,071 51.4
Cigarettes.................................... 64,056 29.6
Any illicit drug.............................. 13,904 6.4
Marijuana..................................... 11,109 5.1
Non-medical use of psychotherapeutics......... 2,665 1.2
Cocaine....................................... 1,505 0.7
Hallucinogens................................. 1,632 0.8
Inhalants..................................... 883 0.4
Heroin........................................ 325 0.2
------------------------------------------------------------------------
*From Preliminary Results from the 1997 National Household Survey on
Drug Abuse.
Of important note here is that the prevalence of past-month use of
heroin in the US Population, age 12 and older, has been steadily
increasing since 1993 when the number of estimated past month users was
at 68,000.
If we look at the age break out of those who have used alcohol,
cigarettes or other drug during the past month we get the following
picture:
Age Intervals
Past Month Use 1997*
[In percent]
------------------------------------------------------------------------
35 and
Substance 12-17 18-25 26-34 older
------------------------------------------------------------------------
Alcohol Use (Any)............... 20.5 58.4 60.2 52.8
Alcohol Use (Heavy)............. 3.1 11.1 7.5 4.0
Cigarettes...................... 19.9 40.6 33.7 27.9
Any illicit drug................ 11.4 14.7 7.4 3.6
Marijuana....................... 9.4 12.8 6.0 2.6
Cocaine......................... 1.0 1.2 0.9 0.5
Heroin.......................... 0.4 0.6 0.2 0.1
------------------------------------------------------------------------
*From Preliminary Results from the 1997 National Household Survey on
Drug Abuse.
You also asked for information on use by race and ethnic groups.
Attached are several tables which indicate demographic characteristics
of the populations using any illicit drug, marijuana, cocaine, alcohol,
and cigarettes which you will find informative. Also attached are
tables summarizing trends since 1979 with regard to any illicit drug,
marijuana, cocaine, alcohol and cigarettes.
With regard to heroin, we are transmitting with these responses a
paper prepared by the Office of Applied Studies in SAMHSA entitled
``Heroin Abuse in the United States.''
The final question asked here is whether S. 324 address any of
these other addictions? S. 324 focuses on schedule IV and V drugs used
for the treatment of opiate addiction. Thus it does not apply to any
medications that would address cocaine, marijuana, inhalant,
hallucinogenics, or any other drug, nor does it focus on alcohol abuse
or cigarettes addiction.
______
Department of Pharmacology
The University of Michigan Medical School
3 June 1999
The Honorable John Dingell
United States House of Representatives
Room 2328
Rayburn House Office Building
Washington, DC 20515-2216
Dear Representative Dingell
It is my understanding that the Commerce Subcommittee on Health and
the Environment of the House of Representatives will soon take up
consideration of S. 324, the Drug Addiction Treatment Act of 1999,
sponsored by Senators Hatch, Levin, and Moynihan. I strongly endorse
this bill. I believe it will have a highly salutary effect on narcotic
addiction through the appropriate use of medication. One of the
important aspects of the bill is the use of buprenorphine by well-
trained physicians to treat narcotic addiction from their offices.
Thus, S. 324 has the potential to attract and treat effectively sizable
populations of currently untreated addicts. A major byproduct of this
increased treatment, of course, will be a reduction in the demand for
illicit narcotics in the United States.
In my career in experimental medicine at the University of
Michigan, I have worked a great deal with buprenorphine in preclinical
research in primates. I have published over a dozen scientific articles
on buprenorphine and its potential as a phamacotherapy for narcotic
addiction. It is remarkably nontoxic and long-lasting relative to other
drugs (e.g., methadone) and should be very attractive to illicit opioid
users who are wary of the stigmatization associated with current
approaches to phamacotherapy of narcotic addiction. S. 324 is both an
important step toward appropriate use of a new medication and new,
physician-based approach to dealing with addiction. I am very hopeful
that you will urge that S. 324 be given careful and urgent
consideration by the Commerce Committee.
I have been very pleased to help Senator Levin and his staff in his
efforts in dealing with drug abuse issues (Congressional Record, 28
January 1999, S. 1091). I was very proud to have been given the
opportunity to show Senator Levin our laboratories at the University of
Michigan and to talk about our efforts toward developing a new
pharmacotherapy for cocaine addiction. This approach utilized a cocaine
catalytic antibody, a way of immunizing an individual against the
effects of cocaine. This work continues to be very promising, and we
are beginning the long process of convincing the scientific community
of its worth.
Incidentally, I have also had the good fortune on a number of
occasions of working with your brother, Jim, when he was at the
National Institute on Drug Abuse. I enjoyed the interaction.
Thank you for your attention to S. 324, and I hope you, too, will
become enthusiastic about its worth.
Yours sincerely,
James H. Woods, Ph.D.
Professor
______
MPHA
July 29, 1999
The Honorable Carl Levin
United States Senate
459 Russell Senate Office Building
Washington, D.C.
Dear Senator Levin: I am pleased to advise you of the support of
the Michigan Public Health Association with your S. 324, the Drug
Addiction Treatment Act of 1999. The Michigan Public Health Association
is an advocate of a variety of substance abuse treatment programs that
meet the particular needs of individuals, including methadone and
buprenorphine treatment in the treatment of opiate addiction through
physician offices. Substance abuse creates psychological, social, and
familial problems.
Estimates from the Institute of Medicine (Institute of Medicine,
1990), a Robert Wood Johnson Foundation report, calculates that there
are about five million users of illicit drugs, but a fourth of them
receive treatment (Institute for Health Policy, 1993). The costs of
substance abuse use problems are great. Substance abuse affects health
care, costs, mortality, workers' compensation claims, reduced
productivity, crime, suicide, domestic violence, and child abuse.
Additionally, there are costs of unnecessary health care, extra law
enforcement, motor vehicle crashes, crime, and lost productivity due to
substance use. Substance abuse interventions that provide an avenue to
regaining a healthy life are critical.
``The Michigan Public Health Association believes the use of the
new medication buprenophine in the treatment of opiate addiction
through physician offices will provide access to treatment for heroin
addicted users. Buprenorphine will allow drug addicted individuals to
maximize everyday life activities, and participate more fully in work
day and family activities while seeking the needed counseling to become
drug free. Individuals who are substance-abuse free have less physical
and sexual abuse, less criminal activity, fewer days lost from work/
school that adds up to tremendous cost savings for society. The overall
goal is to reduce drug use and the risk of the spread of HIV/AIDS,
hepatitis B and C. Access to drug addiction treatment will increase the
potential of physical and mental health for many people in the
community.''
Please let me know if the Michigan Public Health Association can be
of further assistance to you with the passage of this important
legislation. My telephone number is (313) 874-3084.
Sincerely,
Stephanie Meyers Schim, PhD, RN,
President of the Michigan Public Health Association
cc: Mohammad N. Akhter, MD, MPH
Executive Director
American Public Health Association
Mr. Bilirakis. Thank you very much, Senator. Your remarks
were well said certainly.
Do you agree that the legislation that was submitted in the
House, actually was prepared and introduced by Chairman Bliley,
is essentially a companion of yours and essentially the same?
So you certainly endorse it.
Senator Levin. Absolutely.
Mr. Bilirakis. Over in the Senate you haven't had any
opposition?
Senator Levin. None. In fact, we have a great deal of
bipartisan support, and I have also statements of Senators
Moynihan and Biden which I would submit for the record in
support of the bill.
[The prepared statements of Hon. Daniel P. Moynihan and
Hon. Joseph R. Biden, Jr. follow:]
Prepared Statement of Hon. Daniel P. Moynihan, a U.S. Senator from the
State of New York
Mr. Chairman, thank you for the opportunity to participate in this
hearing to address the issue of the availability of new medications,
such as buprenorphine, to block the craving of addictive substances,
such as heroin.
Determining how to deal with the problem of addictive substances is
not a new topic. Just over a decade ago when we passed the Anti-Drug
Abuse Act of 1988, I was assigned by our then-Leader Robert Byrd, with
Sam Nunn, to cochair a working group to develop a proposal for drug
control legislation. We worked together with a similar Republican task
force. We agreed, at least for a while, to divide funding under our
bill between demand reduction activities (60 percent) and supply
reduction activities (40 percent). And we created the Director of
National Drug Control Policy (section 1002); next, ``There shall be in
the Office of National Drug Control Policy a Deputy Director for Demand
Reduction and a Deputy Director for Supply Reduction.''
We put demand first. I made the case, if you have any illusion that
you can ever interdict the supply of drugs, well, don't let the
National Institute of Mental Health find that out because they might
well take a closer examination. There's no possibility.
I have been intimately involved with trying to eradicate the supply
of drugs into this country. It fell upon me, as a member of the Nixon
Cabinet, to negotiate shutting down the heroin traffic that went from
central Turkey to Marseilles to New York--``the French Connection''--
but we knew the minute that happened, another route would spring up.
That was a given. The success was short-lived. What we needed was
demand reduction, a focus on the user. And we still do.
Demand reduction requires science and it requires doctors. I see
the science is becoming available, and the bill we are here to discuss
offers us an important step in allowing doctors to make use of it.
Congress and the public continue to fixate on supply interdiction
and harsher sentences (without treatment) as the ``solution'' to our
drug problems, and adamantly refuse to acknowledge what various experts
now know and are telling us: that addiction is a chronic, relapsing
disease; that is, the brain undergoes molecular, cellular, and
physiological changes which may not be reversible.
What we are talking about is not simply a law enforcement problem,
to cut the supply; it is a public health problem, and we need to treat
it as such. We need to stop filling our jails under the misguided
notion that such actions will stop the problem of drug addiction.
______
Prepared Statement of Hon. Joseph R. Biden, Jr., a U.S. Senator from
the State of Delaware
Nearly ten years ago, in December 1989, I released a Senate
Judiciary Committee Report entitled ``Pharmacotherapy: A Strategy for
the 1990s.'' In this report I argued that there was scientific promise
for medicines that might lessen an addict's craving for cocaine and
heroin, as well as to reduce their enjoyment of those drugs.
This report asked the question: ``If drug abuse is an epidemic, are
we doing enough to find a medical `cure'?''
At the time, despite the efforts of myself and other members of
Congress, the answer to that question was as clear as it was
distressing: the nation was doing far too little to find medicines that
treat the disease of drug addiction.
To address this shortfall, I authored, along with Senator Kennedy,
the Pharmacotherapy Development Act--which passed into law in 1992. The
cornerstone of this Act was its call for a ten year, $1 billion effort
to research and develop anti-addiction medications.
I cannot think of a more worthwhile investment. There is no other
disease that effects so many, directly and indirectly. We have 14
million drug users in this country, four million of whom are hardcore
addicts. We all have a family member, neighbor, colleague or friend who
has become addicted. We are all impacted by the undeniable correlation
between drugs and crime--an overwhelming 80 percent of the 1.8 million
men and women behind bars today have a history of drug and alcohol
abuse or addiction or were arrested for a drug-related crime. It only
makes sense to unleash the full powers of medical science to find a
``cure'' for this social and human ill.
Ten years ago, the question was: ``Are we doing enough to find a
`cure'?'' Unfortunately that question is still with us. But today we
also have another question: ``Are we doing enough to get the ``cures''
we have to those who need them?'' We have an enormous ``treatment gap''
in this country. Only two million of the estimated 4.4 to 5.3 million
people who need drug treatment are receiving it. Licensing qualified
doctors to prescribe Schedule IV and V medications from their offices
is a significant step toward bridging the treatment gap.
Right now we have some highly effective pharmacotherapies to treat
heroin addiction and we are still working on developing similar
medications for cocaine addiction. Access to currently available
medications such as methadone and LAAM (Levo-Alpha Acetylmethadol) has
been strangled by layers of bureaucracy and regulation. As a result,
only 22 percent of opiate addicts are now receiving pharmacotherapy
treatment. General McCaffrey is leading the charge to fix that problem
and I applaud his efforts.
The difficulties of distributing treatment medications to addicts
not only hurts those who are not getting the treatment they need, but
it also stifles private research. I have often bemoaned the fact that
private industry has not aggressively developed pharmacotherapies. As
we increase access to these drugs, we increase incentives for private
investment in this valuable research.
I am proud to be a cosponsor of ``The Drug Addiction Treatment Act
of 1999'' because it ensures that the product gets to market. By
allowing certain doctors to dispense Schedule IV and V drugs from their
offices, the bill expands treatment flexibility and access and
encourages others to develop similar medications.
Mr. Chairman, I am encouraged that you have convened this hearing
today to discuss the House version of this bill. I look forward to
working with you on this most important matter.
Senator Levin. And I very much support the companion bill
here, which I understand is similar or the same to ours.
One final important point, States can opt out of this. If a
State does not want to permit this, it has 3 years to opt out.
It is a very important provision because there is an argument
that a State may want to opt out of this provision, and we give
that opportunity to the States.
Mr. Bilirakis. Thank you very much, sir. I know the Senator
has a vote taking place in the Senate. He seems to be patient
enough if we have any sort of quick question we may want to ask
him?
Chairman Bliley. No, Mr. Chairman. I just want to thank the
Senator for coming over and thank him for what he is doing in
the Senate. And I have no questions.
Mr. Bilirakis. Thank you.
Mr. Brown, anything at all?
Mr. Brown. Thank you, Senator Levin, for joining us.
Mr. Bilirakis. Thank you Senator. Working together I think
we are going to move right ahead with this.
All right. We will go into opening statements, and I am
going to ask for brevity, hopefully. We know what the topic of
today's hearing is. The hearing is being held in response to
the growing trend of heroin addiction among America's youth. In
the past decade heroin addiction has grown fivefold, as I
believe one of the Senators said, among teenagers. And
according to the Office of National Drug Control Policy, part
of this increase in such use is due to the increasing purity of
heroin sold on the street. This level of purity leads those
users to sniff or smoke it, and traditionally this has been an
injected drug. Unfortunately, there is a mistaken belief among
youth that it is not as addictive if it is not injected.
The Drug Addiction Treatment Act would ease regulatory
requirements for qualified physicians. If necessary conditions
are met, doctors would be able to prescribe new and safer
antiaddiction medication in their offices without additional
Drug Enforcement Administration registration. The new drug that
is likely to meet the requirements of this act is
buprenorphine. Health and Human Services Secretary Shalala has
said that this new drug, and I quote--this is also in the
letter that was just put in the record--is ``expected to reach
new groups of opiate addicts.'' Buprenorphine has been cited as
a viable alternative for those who do not have access to
methadone programs, those who are reluctant to enter methadone
treatment programs, and those who are unsuited to methadone
programs. Secretary Shalala has stated that people in their
first year of opiate addiction or those addicted to lower doses
of opiates are not suited for methadone treatment programs. As
the Secretary said, this treatment, and again I quote, should
increase the amount of treatment capacity available and expand
the range of treatment options can be used by physicians, end
quote.
I look forward to the testimony of all of our witnesses,
and I hope that they can help us better understand the problems
of drug dependence and help us craft legislation to help
Americans struggling with heroin addiction.
I now yield to Mr. Brown.
Mr. Brown. Thank you, Mr. Chairman, for arranging today's
hearing. I especially appreciate Mr. Bliley's interest and
efforts in the area of drug addiction. Last week over 600,000
Americans used heroin. Last year nearly 80,000 people were
admitted to hospital emergency rooms because of heroin use.
There is wide agreement among researchers that heroin is the
most underreported of all controlled substances in terms of
usage. Take this fact into account when we note that some
researchers believe that 2 to 3 million Americans are currently
recreational heroin abusers.
The face of heroin use is changing. In 1980, a street bag
of heroin was only 4 percent pure. Today the average street bag
ranges from 40 to 70 percent purity. Because the drug is
stronger, it can be introduced into the body in more ways and
still produce a high. Teenagers who would normally shy away
from injecting heroin perceive snorting and inhaling as a safe
method of using heroin. They don't think it can kill them, they
don't even think it can make an addict of them, but these
misconceptions are beginning to show up in statistics.
The Office of National Drug Control Policy tracks heroin
use. Apparently substance abuse counselors are reporting it has
been years since they have seen so many cases of heroin
addiction among teenagers and young adults. Heroin addiction is
a pervasive and destructive agent, and it is killing children.
Clearly it is incumbent upon policymakers to find ways of
combating heroin use and addiction. Before we initiate a
dramatic expansion in access to heroin treatment that are in
themselves controlled substances, we should have some idea of
the consequences. This bill would enable drug treatment for
heroin outside of a clinic setting before pilot testing the
concept. When we initiate a dramatic expansion in the number of
professionals treating drug addicts, we should be sure that the
mode of treatment will actually cure addiction.
This legislation proposes office space drug treatment
without any provision for the behavioral and psychological
aspects of drug addiction. Doctors would be able to prescribe
buprenorphine for heroin addicts and send them home. Common
sense and plenty of research tell us that medication is not
enough; counseling and monitoring are essential.
Finally, the Federal Government should not act unilaterally
on this issue. Drug treatment is administered at the State and
local levels. Their elected representatives and officials
should have a say in drug treatment policy. The Drug Addiction
Treatment Act would preempt for 3 years any State law relating
to substance abuse treatment. Even though States may ultimately
fund most of the methadone, LAAM and buprenorphine prescribed,
as a result of this bill States would have no say in the policy
driving those expenses. I believe all States should cover all
methadone treatment for heroin addicts, but the fact is half
the States don't, including my home State of Ohio. State and
local governments have a voice in drug addiction policy. We
should consult them, not coerce them.
Despite my concerns about the Drug Addiction Treatment Act,
I am glad Chairman Bliley has chosen to focus on substance
abuse treatment. I think today's hearing can be a valuable
beginning to a broader discussion of the issue. And in that
context I hope the chairman will engage in efforts to
reauthorize SAMHSA this year. As the Federal agency responsible
for promoting and facilitating substance abuse treatment,
SAMHSA plays an integral role in our health care systems and in
our communities. That agency also plays an integral role in
regulating substance abuse treatment. We should not circumvent
their expertise or authority to establish an untested policy.
Thank you, Mr. Chairman.
Mr. Bilirakis. Mr. Deal for an opening statement.
Mr. Deal. Don't have one.
Mr. Bilirakis. Mr. Green?
Mr. Green. Thank you, Mr. Chairman. And I will be very
brief. I will just ask for my full statement to be placed into
the record.
Mr. Bilirakis. Without objection the opening statement of
all members of the subcommittee will be made part of the
record.
Mr. Green. Mr. Chairman the Drug Addiction Treatment Act is
an important first step in reversing the trend of drug abuse in
our country. I am proud to be a cosponsor for this potential to
open new doors and safer and better treatment for heroin
addicts, but it is a first step, and Congress needs to speak
loud and clear that substance abuse must be aggressively
addressed on much broader scale than this particular bill.
There is a large need to develop new treatments to combat
substance abuse, but also take actions that would improve
access to the existing treatments. When 25 States do not cover
methadone treatment, which costs less than a dollar a day, it
is one of the only 2 approved treatments for heroin addiction
under our Medicaid programs, how can we can expect them to pay
more for the far more expensive newer treatments? The fact is
as long as Congress continues to neglect the issues of access
of proven treatments, we will be continuing to neglect the
fundamental public health issues facing substance abuse in our
Nation.
I am glad, Mr. Chairman, this is the first step. I am glad
to be a part of it and hope it will continue. I yield back.
Mr. Bilirakis. I thank the gentleman.
Mr. Greenwood.
Mr. Greenwood. No.
Mr. Bilirakis. Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman.
I think it is commendable that we are discussing substance
abuse treatment. I hope that this hearing will lead to
reauthorization of the Substance Abuse and Mental Health
Services Administration. As my colleagues know, on Wednesday
the Senate committee reported out a bipartisan SAMHSA
reauthorization bill. We should not miss the opportunity to
join them in enacting similarly comprehensive legislation.
I suspect my colleagues are already familiar with the
principal barriers to substance abuse treatment. Treatment
waiting lists are months long and getting longer. Substance
abuse block grants are underfunded. There is no parity for
substance abuse coverage.
As promising as buprenorphine may be, this subcommittee's
commitment to substance abuse treatment simply should not begin
and end with this unapproved drug.
The bottom line is that access to a drug in a physician's
office is irrelevant if the patient can't afford treatment.
This is not an oversimplification--just ask the pharmaceutical
industry. According to the Institute of Medicine, ``lack of
insurance and insufficient patient resources to pay for
treatment are frequently cited by the pharmaceutical industry
as deterrents to pharmaceutical investment.''
I applaud the good intentions of the sponsors of this bill,
but I am hopeful that we can reach a consensus on SAMHSA
reauthorization that breaks down all of the barriers to
treatment, not just one.
I thank the Chair and look forward to hearing from our
witnesses.
Mr. Bilirakis. I thank the gentleman.
[Additional statement received for the record follows:]
Prepared Statement of Hon. Cliff Stearns, a Representative in Congress
from the State of Florida
Thank you, Chairman Bilirakis, for holding this important hearing
today. The focus of today's hearing is to examine the detrimental
effects of alcohol and drug abuse on society with a particular focus on
the increase in the use of heroin. In reviewing the testimony of
today's witnesses, I found it very alarming that according to a 1996
study the use of heroin has increased by 46.5%.
Our witnesses will also discuss the need to increase funding for
drug abuse treatment since only 50% of those who need such treatment
can receive it. Interdiction coupled with treatment are the most
effective tools at our disposal for ending this cycle of dependency.
However, some individuals are forced to wait as long as six months
before they can get into treatment programs.
Today more than 600,000 people in the United States will use
heroin. While this drug is traditionally injected, it is now also being
snorted and smoked. That's because there is a general misconception by
our youth that snorting or smoking heroin will not lead to addiction.
This is one of the reasons an increasing number of high school students
are using this as the drug of choice coupled with the fact that it has
increased purity and therefore it is more addictive.
Dr. Thomas Kosten, President of the American Academy of Addiction
Psychiatry will tell us why he believes that buprenorphine should be
made available for the treatment of heroin addiction. He will also
provide us with background on research that is being conducted to
create a cocaine vaccine.
I look forward to hearing from our witnesses about the best means
available in combating drug and alcohol abuse.
Mr. Bilirakis. We will call forward the first panel at this
point in time. Dr. Allen Leshner, Director of the National
Institute on Drug Abuse, is accompanied by Dr. Frank J. Vocci,
Director of the Medications Development Division of the
National Institute on Drug Abuse; and Dr. H. Westley Clark, who
is the Director of the Center for Substance Abuse Treatment,
SAMHSA, here in Rockville, Maryland.
Gentlemen, there is a vote on the floor. I am not sure
whether Mr. Bliley or someone might return in time to keep us
going here, but we will try it for another 5 minutes, but we
may have to break.
Your written statement is a part of the record. I would
hope that you would complement and supplement that statement
orally. I am not even going to set a clock here, but I would
hope that somewhere between 5 to 10 minutes would cover your
testimony.
Mr. Bilirakis. Dr. Leshner.
STATEMENTS OF ALAN I. LESHNER, DIRECTOR, NATIONAL INSTITUTE ON
DRUG ABUSE, ACCOMPANIED BY FRANK J. VOCCI, DIRECTOR,
MEDICATIONS DEVELOPMENT DIVISION, NATIONAL INSTITUTE ON DRUG
ABUSE; AND H. WESTLEY CLARK, DIRECTOR, CENTER FOR SUBSTANCE
ABUSE TREATMENT
Mr. Leshner. Thank you, Mr. Chairman.
Mr. Chairman, members of the subcommittee, I am very
pleased to be here to discuss how science is providing us with
unprecedented opportunities to develop and bring new and
effective treatments to those suffering from the devastating
effects of addiction, many of which we have already spoken
about this morning.
I am accompanied on my right by Dr. Frank Vocci, who is the
Director of NIDA's Division of Medications Development.
The encouraging news is that we have in the clinical tool
box a variety of effective treatments that can be used to
combat addiction. The bad news is that we don't have enough of
them. It is particularly important that we have more and better
medications to add to the clinician's tool box.
This particular point has been made ever more clear as we
have learned more and more about the centrality of biological
factors, particularly brain changes, in the addiction process
itself. And let me provide just one example of what we are
learning. I would ask my colleague to lift this poster on my
right. This demonstrates the long-lasting effects that a
particular drug, in this case methamphetamine, can have on the
human brain. These scans are measuring the ability of the brain
to bind the neurotransmitter dopamine to a particular control
mechanism, the dopamine reuptake transporter. The bright colors
reflect more binding and dull colors less transporter binding,
and I won't go into the detail of what that all means. However,
the scan on the left is of a nondrug user, but the next one is
of a methamphetamine addict who was drug-free for about 3 years
when this image was taken. That is a persistent long-lasting
effect that lasts 3 years after the individual has stopped
taking that drug. This is followed by a scan of a methcathinone
abuser who is also drug-free for 3 years, and the last image is
of a Parkinson's disease patient.
Now, when compared with the control on the left, the former
methamphetamine user has significantly lost the ability to
transport dopamine back into brain cells. And this brain change
can have a wide range of long-lasting behavioral consequences,
in particular on emotion and on cognitive functioning. These
kinds of differences between the addicted brain and the
nonaddicted brain illustrate why we consider addiction to be a
brain disease that requires biological as well as behavioral
interventions.
It is also important that a significant amount of both
scientific evidence and clinical observation support the fact
that medications such as methadone and LAAM, which are already
available for heroin addiction, can stabilize many patients and
facilitate their return to productive functioning in society.
These medications have been shown to be highly effective in
reducing drug use, HIV infection rates and criminal activity,
and in enhancing societal productivity. But as good as these
medications are, there need to be more treatment options
available to clinicians. Just as for any other illness, no
single medication is appropriate for all patients, and we have
far too few medication options for addiction, including heroin
addiction.
Getting new medications developed, however, has been a
formidable challenge. For one thing, despite the clinical
success of medications like methadone, there has been a
tremendous reluctance on the part of the pharmaceutical
industry to develop antiaddiction medications. They perceive an
inadequate market; are fearful of being stigmatized for working
on medication's for addiction; and they see regulatory
complexities that impede getting an approved medication like
this to market. All of these factors, in addition to the fact
that to bring any medication to market typically costs between
350 and $600 million, makes it easy to see why the Congress
chose to authorize the medication discovery and development
program within my institute, the National Institute on Drug
Abuse.
Our Medication Development Program funds research at every
step of the complex medication development process from the
chemical synthesis of compounds to conducting clinical trials
that evaluate the safety and efficacy of potential new
medications. This program builds in an integrated way on many
of the basic scientific discoveries that are coming so rapidly
in our field.
Let me just give you one quick and brief illustration of
the close tie that exists between basic science findings about
the mechanisms of drug action in the brain and the development
of new medications.
Mr. Bilirakis. Doctor, forgive me. I can't speak for the
others, but I can't really pay as much attention as I would
like to because I am concerned about the vote. So maybe what we
should do is break at this point.
Now, if Mr. Bliley gets back and wants to keep it rolling
at that point in time with your permission, then----
Mr. Waxman. It is okay, but it is harder to concentrate
when you are not even in the room.
Mr. Leshner. I will wait.
Mr. Bilirakis. So we will recess for at least a few minutes
so that we can get over there and cast a vote and get back.
[Brief recess.]
Chairman Bliley. In order to keep things moving along, the
chairman of the subcommittee asked me to reopen the hearing.
Where were we, Marc?
Mr. Leshner. I am about in the middle, sir.
Chairman Bliley. Go right ahead.
Mr. Leshner. Thank you. I promise not to start again. But I
was speaking about the difficulty in getting new medications
developed and the difficulty in getting new medications
produced by pharmaceutical companies in part because of the
perceived lack of a market for these medications and the stigma
that attaches to them. That set of issues is why the Congress
chose to establish within the National Institute on Drug Abuse
the Medications Development Program, which is run by my
colleague here Dr. Frank Vocci. What our program does is to
build in an integrated way on many of the basic scientific
discoveries that are coming so rapidly in our field, and I
would like to use just one quick example to help illustrate the
close tie between basic findings about the mechanisms of drug
action in the brain and the development of potential new
medications.
We know that cocaine, like methamphetamine, works primarily
through modifying the activity of the neurotransmitter chemical
dopamine. And that suggests that if we can appropriately modify
cocaine's effects on dopamine, we might be able to reduce its
hold on addicts. Well, a study reported just last week in the
journal, Nature, suggests exactly that. The researchers
synthesized a new compound called BP 897 that expressly
modifies cocaine's effects on dopamine's principle receptor in
the brain, the D3 receptor. And this compound reduced the
ability of drug-related cues to cause relapses in drug-
abstinent animal subjects. This, of course, then suggests that
this compound BP 897 might well be a potential anticocaine and
antiaddiction medication, and therefore we are pursuing it
vigorously.
The point is there is a tie between basic science findings
and our medication development targets. The medications we
develop must not only be safe and effective, but they also must
be readily used and accepted by the populations that we are
treating. The studies we have completed on the medications
buprenorphine and buprenorphine combined with naloxone have
shown this to be the case. These medications are safe and
effective, and they are readily accepted by patients.
Buprenorphine is a partial mu opiate receptor agonist with
unique properties which differentiate it from full agonists
such as heroin or other kinds of agonist compounds like
methadone or LAAM. Importantly, by adding naloxone to
buprenorphine, we were able to minimize substantially the
likelihood that it might be abused.
These products are well-tolerated by addicts, and they have
low value and desirability on the street. These traits make
this medication a prime candidate to be administered in less
traditional environments such as office-based settings.
Consistent with the recent Institute of Medicine Report and
the recent National Institutes of Health Consensus Development
Conference on the Effective Medical Treatment of Heroin
Addiction, we believe that administering these medications in
less regulated environments will significantly expand access
and, therefore, the number of patients in treatment. It is very
important in this context to emphasize that we believe that
buprenorphine and buprenorphine naloxone would not be
replacements for methadone or LAAM, but yet additional
treatment options for both physicians and patients.
As in all areas of medicine, it is critically important to
give physicians and patients ready access to as many different
forms of treatment as may be available and then to choose the
best match for each individual patient.
Mr. Chairman, we look forward to continuing success in our
quest to develop more effective treatments, help reduce the
burden of addiction for the addict, the family, and the
communities. We thank you and your colleagues for the
bipartisan support which has made our work so successful. After
Dr. Clark's testimony, I understand, my colleague and I will be
delighted to answer any questions you might have.
[The prepared statement of Alan I. Leshner follows:]
Prepared Statement of Alan I. Leshner, Director, National Institute on
Drug Abuse, Department of Health and Human Services
Mr. Chairman and Members of the Subcommittee, I am pleased to be
here today to discuss how science is providing us with unprecedented
opportunities to develop more and improved treatments for those
suffering from the disease of addiction. The science I present this
morning will be particularly relevant to the Drug Addiction Treatment
legislation that is the topic of this hearing.
Given that drug abuse and addiction affects every American either
directly or indirectly with the economic burden alone for drug abuse
estimated to exceed $109 billion in the latest estimate, it is
imperative that we utilize science to develop new and improved
approaches to alleviate the devastating effects of this disease.
Scientific advancs, particularly over the past decade, have
catapulted both our understanding and our approaches to addiction.
Research has in fact come to define addiction as a chronic, and for
many people reoccurring disease characterized by compulsive drug
seeking and use that results from the prolonged effects of drugs on the
brain. A variety of studies in both humans and animals have
demonstrated that chronic drug use does in fact change the brain in
fundamental ways that persist long after the individual has stopped
taking drugs. By using advanced brain imaging technologies we can see
what we believe to be the biological core of addiction. What you are
seeing in this image (Figure 1) is dopamine transporter binding in four
different adults. Brighter colors reflect greater dopamine binding
capacity. The scan on the left is that of a non-drug user, the next is
of a chronic methamphetamine user who was drug free for about three
years when this image was taken, followed by a chronic methcathinone
abuser who was also drug free for about three years. The last image is
of the brain of an individual newly diagnosed with Parkinson's Disease.
When compared with the control on the left, one can see the significant
loss in the brain's ability to transport dopamine back into brain
cells. Dopamine function is critical to emotional regulation, is
involved in the normal experience of pleasure and is involved in
controlling an individual's motor function. The data now suggest that
every drug of abuse--be it nicotine, heroin, cocaine, marijuana or
amphetamine--appears to increase the levels of the neurotransmitter
dopamine in the brain pathways that control pleasure. It is this change
in dopamine that we have come to believe is one fundamental
characteristic of all addictions and is at the biological core of
addiction.
This kind of fundamental knowledge which is generated by NIDA-
supported researchers is used by our Medications Development Program
staff to develop new targets and approaches for medications. For
example, as reported just last week in the Journal Nature, NIDA-
supported scientists in collaboration with researchers from the
Institut National De La Sante Et De La Recherche Medicale in France
applied basic research findings about dopamine and cocaine addiction to
develop and test a potential new compound for cocaine addiction. The
researchers have developed a compound, BP 897, that appears to reduce
cocaine ``craving'' in animals. The selective partial agonist BP 897
works on the D3 receptor, one of the known dopamine receptors found on
the surface of brain cells, that is thought to be involved in the
reinforcing effects of cocaine. The compound was found to reduce
cocaine-seeking behavior in rats trained to associate cocaine taking
with a light. The light represents an environmental cue or stimulus,
which the rat learns to associate with cocaine administration, the same
way that the mere sight of drug paraphernalia can trigger craving in
human cocaine addicts who have been abstinent for years. The compound
was found to block the cued response, thus bringing us one step closer
to having a medication for cocaine addiction.
Given that the development of new and effective medications for the
treatment of addiction is both a national need and a NIDA priority, it
is imperative that we capitalize on recent research advances like this
to rapidly bring new medications to the clinical toolboxes of front
line clinicians who are treating addiction. Just as medications have
been developed for other chronic diseases, such as hypertension,
diabetes, and cancer, drug addiction is a disease that also merits
medication for its treatment.
We have already made great progress in bringing quite an array of
useful tools to drug abuse professionals to treat addicted individuals,
such as the readily available nicotine addiction therapies; the most
effective medications to date for heroin addiction, methadone and LAAM,
levo-alpha-acetyl-methadol (trademark ORLAAM), which I will discuss in
more detail shortly; as well as a number of notable standardized
behavioral interventions, such as cognitive behavioral therapies and
contingency management, that are effective in treating both adults and
adolescents.
Although we are optimistic that science can help bring more
effective treatments to the Nation's forefront, there is a tremendous
national need to bring these medications to fruition at a quicker pace
and to increase access to treatment. When one takes into account that
there are approximately 810,000 persons in need of treatment for heroin
addiction and only space in the existing methadone clinic system for
180,000 patients, the need for expanding treatment for this population
takes on new light.
The need to bridge the treatment gap by developing new treatments
that are accessible to those in need is a point articulated strongly by
the Institute of Medicine, as well as the National Institutes of
Health's November 1997 Consensus Development Conference on the
Effective Medical Treatment of Heroin Addiction, among others.
Methadone, the medication that has been shown to have the most
favorable impact on mortality, morbidity and the interruption of drug-
seeking behaviors is still inaccessible to many. An abundance of
studies have also consistently shown that methadone is highly effective
in retaining in treatment a large proportion of patients, reducing
their intravenous drug use and criminal activity and enhancing their
social productivity. Despite the clinical success of medications such
as methadone, pharmacotherapy for the treatment of drug addiction has
received far too little attention, particularly from the pharmaceutical
industry.
In an effort to stimulate the availability of medications to treat
drug addiction, Congress authorized (P.L. 99-570) a drug discovery and
development program within NIDA. To work with industry to perform the
research and development necessary to secure FDA marketing approval for
new medications to treat drug addiction, NIDA established its own
Medications Development Division (MDD) in 1990, which is headed by my
colleague, Dr. Frank Vocci.
By funding research at every step of the complex medications
development process; from the chemical syntheses, and the biochemical,
behavioral, pharmacological, and toxicological testing, to the clinical
trials that evaluate the safety and efficacy of potential medications,
NIDA offers pharmaceutical firms and academia the resources and the
technical assistance to perform the necessary next steps to bring a
medication to market. MDD also aggressively pursues ways to facilitate
and accelerate the medications development process. An additional
economic incentive for anti-addiction medication development can come
from the Food and Drug Administration under the Orphan Drug Act
It was NIDA's MDD that shepherded through the final development of
the Nation's most recent tool to combat heroin addiction, LAAM. LAAM,
like the better known medication methadone, stabilizes the brains of
heroin addicts by ameliorating craving for heroin and preventing
withdrawal symptoms. Treatment with methadone requires daily dosing,
whereas LAAM is effective for up to three days.
LAAM was approved by the Food and Drug Administration (FDA) in 1993
after an extensive research cycle that began with the 1968 discovery
that the analgesic LAAM might be a potential treatment for heroin
addiction. Clinical research on LAAM continued intermittently
throughout the 1970s, and 1980s. As LAAM was ``off patent'' for more
than 20 years, no private sector entity attempted to develop LAAM when
it was determined that additional clinical trials would be required.
NIDA advertised and awarded a contract to a small U.S. company,
Biometrics Research Institute, to develop and submit a New Drug
Application for LAAM. This contract eventually resulted in the approval
of LAAM by the FDA. Once the drug was approved in July 1993, there were
still many barriers to overcome. For example, LAAM can only be
distributed to clinics and hospitals that operate licensed narcotic
treatment programs. Clinics had to receive approval to dispense LAAM
from Federal, State and some local authorities. Also, to permit LAAM to
be distributed to treatment programs, states first had to schedule or
reschedule the medication into a Schedule II status, allowing use in
existing treatment settings. States also had to develop treatment
regulations that in some cases took over four years to receive the
necessary approvals. Given these factors, it is not difficult to
understand why, as of May 21, 1999 according to the FDA, of the 934
outpatient Narcotic Treatment Programs in the nation approved for
maintenance and detoxification treatment only 376 are approved to
dispense LAAM. We estimate that 5000 to 6000 patients are currently
receiving LAAM.
This short case scenario of the financial and time consuming
challenges that were overcome to bring LAAM to the market exemplifies
why pharmaceutical companies do not want to invest in anti-addiction
medications. There are virtually no market incentives for
pharmaceutical companies to develop medications for drug addiction. In
fact the congressionally mandated 1995 Institute of Medicine Report,
``The Development of Medications for the Treatment of Opiate and
Cocaine Addictions,'' states that the disincentives for the
pharmaceutical industry to become involved in anti-addiction
medications far outweigh the incentives. The cost of bringing any new
drug to market is enormous, according to the Pharmaceutical Research
and Manufacturers Association. It costs anywhere from $350 to $600
million, and generally requires 10 or more years of a company's
investment, with only one in ten candidate medications eventually being
brought to market. Not only are pharmaceutical companies hesitant to
develop medications for market and financial reasons, but they are
fearful of the stigma that society will attach to them or their drugs
if they were to develop a compound for drug addiction, especially if
the compound has other medical uses. For example, methadone was first
developed as an analgesic. When it was approved for treatment of opiate
addiction it became subject to additional layers of regulation and
became stigmatized. As a result, sales dramatically plummeted. The
industry is well aware of the problems encountered by medications such
as methadone and LAAM. They want an adequate return on their investment
before deciding to enter a new area of drug development. Unfortunately
the majority of the factors they look at, including the size of the
market, the nature of third party reimbursement for drug abuse, the
regulatory requirements for development and approval, the clinical
trials that need to be conducted, and the regulatory barriers
concerning how the product may be administered among others, are seen
as problematic to the company. The bottom line is, if we want
pharmaceutical companies to invest in anti-addiction medications,
incentives must be provided to them to stimulate their interest.
For our part, NIDA will continue supporting basic research, as well
as researching and developing the most effective treatments for the
populations we are treating. We have learned a lot about treating
opiate addicts from the methadone and LAAM experience. We have learned,
for example that medications that are full agonists such as methadone
and LAAM are very effective in treating heroin addiction. They are also
effective in helping to reduce the spread of infectious diseases, such
as HIV, and hepatitis through reduction of injection practices.
Research has also taught us that we need to develop medications that
will be readily used and accepted by the populations we are treating.
These are some of the reasons that we are working to bring other
medications to the Nation's forefront--buprenorphine and buprenorphine
combined with naloxone.
Buprenorphine is a partial mu opiate receptor agonist with unique
properties which differentiate it from full agonists such as methadone
or LAAM. Partial agonists exhibit ceiling effects, meaning increasing
the dose only has effects to a certain level, so it will be well
tolerated by addicts and have low value and desirability for sale on
the street. Naloxone has been added to buprenorphine to minimize its
abuse potential, particularly with respect to parenteral (intravenous)
abuse. These factors make this medication a prime candidate to be
administered in less traditional environments, thus potentially
expanding treatment to populations who either do not have access to
methadone programs or are unsuited to them, such as adolescents. Just
next month we will be enrolling patients in a buprenorphine/naloxone
office based treatment trial that will help us better refine and
establish best practices for administering this medication.
Buprenorphine and buprenorphine/naloxone (bup/nx) would not be a
replacement for methadone or LAAM, but yet another treatment option for
both physicians and patients. Both methadone and LAAM would continue to
remain an important part of the treatment continuum. Buprenorphine and
bup/nx, however, could help reach new groups of opiate addicts, such as
those in the seven states that do not currently have methadone
programs; those who may be reluctant to enter a methadone program; and
adolescents and new heroin addicts who are unsuited to methadone. As in
all forms of medicine, it is critically important to allow physicians
and patients to have access to as many forms of treatment as may be
available, and to chose the best match for each individual.
It is also important that physicians are knowledgeable about
addiction and the comprehensive approach required for treatment to be
effective. As noted in the November 1997 National Institutes of Health
Consensus Development Statement, non-pharmacological supportive
services are pivotal to successful treatment. Ongoing substance abuse
counseling and other psychosocial therapies, vocational rehabilitation,
and other needed medical and social services are essential for program
retention and positive outcome.
NIDA will continue to work with health care professionals and to
conduct trials of buprenorphine products in varied environments, such
as primary care and mental health clinics, to expand treatment
availability and to ensure the effectiveness of these medications in
real world settings. It should be noted, however, that neither of these
products have yet been approved by the FDA to treat narcotic addiction.
As with all medical conditions, science will continue to provide us
with the best hope. It is science that will help us develop even more
novel approaches to treat addiction. Our only other hope is that when
these new treatments are developed and tested, they will rapidly be
provided to those who need them most.
Thank you for the opportunity to testify before this Subcommittee.
My colleague and I will be happy to respond to any questions.
Chairman Bliley. Dr. Clark.
STATEMENT OF H. WESTLEY CLARK
Mr. Clark. Good morning, sir. I want to thank you and the
other subcommittee members for having this hearing. This
opportunity is very important.
Mr. Bilirakis. Please proceed, Doctor.
Mr. Clark. Although I won't get into the specifics of the
proposed legislation, I believe in general SAMHSA shares the
subcommittee's concerns about making treatment medications
available in an expeditious and prudent way. Further I would
like to commend the subcommittee and the Senate for their
attention to this important detail and commend Senator Hatch
and Senator Levin for appearing before you.
In addition, I would like to express the hope that the
subcommittee will consider the reauthorization of SAMHSA's
programs this year. As the statements of others before me have
indicated, the development and introduction of new treatment
medications is an important part of our Nation's overall effort
to reduce substance abuse and addiction, but addressing the
SAMHSA programs will give us broad authorities to improve our
ability to expand and approve treatment and to address some of
the issues that were raised by other members, by members of the
subcommittee, in terms of their concern.
SAMHSA under the authority of the Narcotics Addict
Treatment Act has also started to address the need for
treatment standards for new treatment medications when such
medications like buprenorphine/naloxone may be approved. As
part of this effort, we have initiated a wide range of
discussion with treatment providers, researchers, State
officials and staff from NIDA, FDA, DEA and ONDCP on how a new
system might work most effectively and safely to give the
public the maximum benefit that may be available through new
pharmacotherapeutic adjuncts to treatment. SAMHSA is beginning
to identify issues and concerns from these discussions that
relate to provisions in the draft legislation.
First and foremost there is a need to consider a transition
period following the approval and market availability of new
medications. This transition period would allow for the
generation and analysis of treatment experience data and would
help to ensure that public health risks associated with
diversion and other factors are minimized. Moreover, this
transition period will permit SAMHSA to continue to work with
the medical community and other groups to develop physician
training programs tailored for new medication. The transition
period would also allow SAMHSA to work with its partners to
determine what services, including psychosocial services, will
optimize the effectiveness of new medications and how such
services will be provided to patients in different settings.
When we shift from the previous setting of clinics, we need to
make sure that the psychosocial needs of patients are
addressed.
In carrying out its new responsibilities under NATA, SAMHSA
will strive to fulfill the intent of NATA. We share the
subcommittee's goal to balance the need to ensure that narcotic
addiction treatment is provided in accordance with standards
and that medication diversion concerns are fully addressed.
We recognize that historical and other factors have led to
a unique system for the treatment of opiate addiction with
opiate agonists such as methadone. The unintended result is
methadone treatment is almost completely separated from the
rest of medical practice. As a physician and researcher, I can
tell you personally that this is particularly burdensome.
SAMHSA is working to enhance the effectiveness of treatment
provided in the traditional narcotic treatment program. In
addition, the agency is working with various partners to
investigate and evaluate alternatives to this system for future
medications like buprenorphine NX, which have pharmacologic
properties much different from methadone and LAAM.
As a Nation we need to find solutions to get more patients
into effective treatment. Epidemiologic reports indicate that
heroin abuse continues to rise in many regions including parts
of Florida and California. Surveillance also indicates
increases for women and youth. Public health agencies are
struggling to address the problems of adolescent heroin
addiction, HIV/AIDS, as well as hepatitis, tuberculosis and
other infectious diseases associated with drug abuse. Part of
our public health response has to be the availability of
effective treatment earlier in the course of addiction than has
previously been the practice and in channels where it has not
been available before, such as primary care settings. If
effective intervention begins earlier in the course of
addiction, before too many of the psychosocial and
developmental complications have occurred, it may be possible
in some patients to preempt the usually protracted and chronic
course of heroin addiction. The availability of effective
medications and the patients' need for these will give the
physicians a reason to stay involved while the newly diagnosed
patient negotiates the unfamiliar world of counseling,
treatment, contracts, and self-help groups.
I want to emphasize that based on my personal experience as
a treating clinician and researcher, it is essential but
sometimes complicated to treat drug addicts effectively. Most
heroin addicts require a combination of medical as well as
psychosocial intervention. Treatment medications may themselves
be somewhat abusable, in which case systems must be created to
minimize their abuse and diversion. Since the group of patients
to be treated with new medications are the same patients at
highest risk for abuse and diversion of all medications, the
system to minimize and monitor for diversion must be especially
robust.
We believe that we not only can, but must, strive to
maximize the medical and public health benefits of new
medications as well as the existing medications, including
methadone, LAAM and others. It is imperative as we proceed,
however, that we take care to minimize any risk these
treatments may present to the public. I want to make it
particularly clear as having some awareness of the process that
if indeed we are not cautious as we proceed, we will actually
structure disincentives for the pharmaceutical industry to be
involved.
We believe that with the transition period about which we
are talking and that we are developing from a regulatory
perspective, we can ensure in a reasonable period of time the
pharmaceutical industry will not be embarrassed by a hasty
introduction of new therapies without a common psychosocial
adjunct, because at the end of this process, if we have a
fiasco, not only do we lose the interest of the pharmaceutical
industry, we also lose an effective medication or an effective
treatment option.
This is really critical. We are working on and developing,
we believe, a regulatory approach which would not be burdensome
on the pharmaceutical industry, which would foster the intent
of the legislation being proposed. We are perfectly happy,
however, to work with the subcommittee on addressing some of
these issues.
[The prepared statement of H. Westley Clark follows:]
Prepared Statement of H. Westley Clark, Director, Center for Substance
Abuse Treatment, Substance Abuse and Mental Health Services
Administration, Department of Health and Human Services
Good morning Mr. Chairman and Subcommittee members. I would like to
thank the Subcommittee for the opportunity to testify on the proposed
Drug Addiction Treatment Act of 1999 and how that proposal relates to
the role of the Center for Substance Abuse Treatment, which is part of
the Substance Abuse and Mental Health Services Administration. Although
I will not address the specifics of the proposed legislation, I believe
that, in general, CSAT shares the Subcommittee's concerns about making
treatment medications available in an expeditious and prudent way.
Further, I would like to commend the Subcommittee and the Senate for
their attention to this important public health issue.
CSAT shares the Subcommittee's views on the importance of
medications to treat substance abuse and drug addiction. Indeed, some
of the most successful and cost-effective therapies available in the
substance abuse treatment field today are those that use medication
adjuncts. These therapies build on the large investment the public has
already made in both the basic and clinical research on addiction
funded by the Department.
CSAT's Role. CSAT serves a critically important role in the
substance abuse treatment area as the primary Federal agency
responsible for substance abuse treatment issues. The Center's mission
is to improve the lives of individuals and families affected by alcohol
and drug abuse by ensuring access to clinically sound, cost-effective
addiction treatment that addresses the health and social costs of
addiction to our communities and the nation. Our role includes the
development and dissemination of substance abuse treatment guidelines,
many of which address the use of treatment medications that are of
particular interest to this Subcommittee and clearly related to this
hearing. Indeed, the Center has prepared and issued 33 Treatment
Improvement Protocols and 23 Technical Assistance Publications,
including treatment guidelines on the use of naltrexone, methadone and
LAAM, medications used in the treatment of addiction. It is likely that
future medications will also be the subject of treatment guidelines.
But CSAT's role is not limited to developing and disseminating
treatment guidelines. While treatment guidelines provide up-to-date,
scientific information on the treatment parameters, CSAT will have an
increasing role in determining appropriate treatment standards for
medications that require such standards under Federal law. These new,
direct oversight activities complement the Center's longstanding
commitment to provide technical assistance to the drug abuse treatment
field. CSAT's treatment mission focuses on reducing treatment waiting
time, reducing the ``treatment gap'' and improving patient treatment
outcomes.
Existing Federal Law. The Narcotic Addict Treatment Act (NATA) has
established a special system for Federal oversight in this area.
Briefly, this legislation, enacted in 1974, requires a separate DEA
registration under the Controlled Substances Act (CSA) for
practitioners who use scheduled narcotic drugs in the maintenance or
detoxification treatment of narcotic addiction. The special
registration is based on a determination by the Secretary that the
practitioner is qualified, under standards established by the
Secretary, to provide this type of treatment. These standards are
reflected in regulations developed and enforced currently by the Food
and Drug Administration (FDA). This regulatory system has provided a
framework for practitioners to use narcotic drugs to treat narcotic
addiction and has discouraged the inappropriate dispensing of narcotic
treatment drugs. FDA has approved and DEA has registered over 900
treatment programs under this regulatory system. Both agencies monitor
these programs under separate regulations. The Department's regulations
under the NATA authority establish the conditions for using approved
narcotic drugs in the treatment of addiction. Methadone and LAAM are
the only two medications addressed in the current regulations. Finally,
most States, and some counties and cities have narcotic treatment
regulations in place.
Treatment Standards for New Medications. CSAT, under the authority
of the NATA, has also started to address the need for treatment
standards for new treatment medications, when such medications, like
buprenorphine/naloxone (nx) may be approved. As part of this effort, we
have initiated wide-ranging discussions with treatment providers,
researchers, state officials and staff from NIDA, FDA, and ONDCP on how
this new system might work most effectively and safely, to give the
public the maximum benefit that may be available through new
pharmacotherapeutic adjuncts to treatment. CSAT is beginning to
identify issues and concerns from these discussions that relate to
provisions in the draft legislation. I will briefly mention a few
general concerns for the Subcommittee to consider as it deliberates in
the future.
First and foremost is the need to consider a transition period
following the approval and market availability of new medications. This
transition period would allow for the generation and analysis of
treatment experience data and would help to ensure that public health
risks associated with diversion and other factors are minimized.
Moreover, this transition period would permit CSAT to continue to work
with the medical community and other groups to develop physician
training programs tailored for new medications. A transition period
would also allow CSAT to work with its partners to determine what
services, including psychosocial services, will optimize the
effectiveness of new medications and how such services should be
provided to patients in different settings.
In carrying out its relatively new responsibilities under the NATA,
CSAT will strive to fulfill the intent of the NATA. We share the
Subcommittee's goal to balance the need to assure that narcotic
addiction treatment is provided in accordance with standards and that
medication diversion concerns are fully addressed.
Other Factors--Effective medical adjuncts already available for
drug abuse treatment are underutilized, and new medications, to augment
methadone and LAAM, have not been developed. A 1996 Institute of
Medicine report identified Federal and State narcotic treatment
regulations as important factors that adversely affect the development
of new medications for addiction treatment. That same report discussed
the need to increase the number of health professionals with addiction
treatment training. In addition, many of the people who need and could
benefit from pharmacotherapy are not likely to be insured, even for
general medical coverage. It is clear that an effective strategy in
this area is one which can address as many of these concerns as
possible.
Changes in Regulatory Oversight. The current regulatory oversight
system is in a period of transition. Last week, SAMHSA and FDA issued a
proposed rule to substantially revise the longstanding Federal
methadone regulation system. FDA, SAMHSA, DEA and the White House
Office of National Drug Control Policy (ONDCP) developed this proposal
to modernize and streamline the current regulatory system and to
replace FDA's direct regulatory inspections with an accreditation-based
approach, built on the same kind of peer-review that is standard in
hospitals and other health care settings. The Department believes the
proposed changes will enhance the quality of opioid treatment by
allowing increased clinical judgement in treatment and through the
accreditation process itself, with its emphasis on continuous quality
assessment. CSAT will assume oversight responsibility upon finalization
of these new rules.
Alternative Treatment Models. Historical and other factors have led
to a unique system for the treatment of opiate addiction with opioid
agonists such as methadone. The unintended result is that methadone
treatment is almost completely separated from the rest of medical
practice. CSAT is working to enhance the effectiveness of the treatment
provided in the traditional narcotic treatment programs (or ``methadone
clinics''). In addition, the Center is working with various partners to
investigate and evaluate alternatives to this system for future
medications, like buprenorphine/nx, which have pharmacologic properties
much different from methadone and LAAM.
As a nation we need to find solutions to get more patients into
effective treatment. Epidemiologic reports indicate that heroin abuse
continues to rise in many regions, including parts of Florida and
California. Surveillance also indicates increases for women and youth.
Public health agencies are struggling to address the problems of
adolescent heroin addiction and HIV/AIDS, as well as hepatitis,
tuberculosis and other infectious diseases associated with drug abuse.
Part of our public health response has to be the availability of
effective treatment earlier in the course of addiction than has
previously been the practice and in channels where it has not been
available before, such as the primary care setting. If effective
intervention begins earlier in the course of an addiction, before too
many of the psychosocial and developmental complications have occurred,
it may even be possible in some patients to pre-empt the usual
protracted and chronic course of heroin addiction. The availability of
effective medications and the patients' need for these will give the
physicians a reason to stay involved, while the newly diagnosed patient
negotiates the unfamiliar world of counseling, treatment contracts and
self-help groups.
In closing, I would like to emphasize that based on my personal
experience as a treating clinician and researcher, it is essential, but
sometimes complicated, to treat drug addicts effectively. Most heroin
addicts require a combination of medical as well as psychosocial
interventions. Treatment medications may themselves be somewhat
abusable, in which case systems must be created to minimize their abuse
and diversion. Since the group of patients to be treated with new
medications are the same patients at highest risk for abuse and
diversion of all medications, the system to minimize and monitor for
diversion must be especially robust.
We believe that we not only can, but must, strive to maximize the
medical and public health benefits of new medications as well as
existing medications, including methadone, LAAM, naltrexone and others.
It is imperative as we proceed, however, that we take care to minimize
any risks these treatment medication may present to the public.
Mr. Bilirakis. Thank you, Dr. Clark. You didn't have to say
that. I know we would have expected we could all work together
because this is a very important issue.
The Chair yields to Chairman Bliley for any inquiries.
Chairman Bliley. Thank you very much, Mr. Chairman.
Dr. Leshner, the drug czar's office estimates that there
are 810,000 addicts in the United States. Do you agree with
that?
Mr. Leshner. Yes, sir.
Chairman Bliley. How serious then is the problem of heroin
abuse?
Mr. Leshner. Heroin addiction, because it has the tendency
to capture an entire individual's life, is tremendously
important not only for that individual, but for that
individual's family and for the community at large. The total
cost of drug addiction in this country exceeds $110 billion a
year. Most of that comes from addiction itself. So the problem
is tremendously serious.
Chairman Bliley. What is the most promising breakthrough in
the treatment of heroin addiction?
Mr. Leshner. I believe that methadone and LAAM are
tremendously effective medications and need to be continued. I
believe that buprenorphine and buprenorphine combined with
naloxone in particular will be among the most important
treatment innovations that will have occurred in the last few
decades.
Chairman Bliley. Dr. Clark, heroin is a schedule I.
Methadone is schedule II. Tylenol with codeine is schedule III.
But buprenorphine is a schedule V. What is the difference
between schedule II and a schedule V drug?
Mr. Clark. Sir, the schedule II drug has been determined to
be very abusable. Schedule V drugs have also been determined
not to be particularly abusable and have good health effects.
So schedule II drugs may have good health effects, but are
abusable.
Alternatively in the scheduling process, what you have is
that a schedule V drug may not have as much street experience,
and therefore does not--the abuse potential is not quite clear
because of the lack of street experience. And buprenorphine
being a sublingual medication heretofore has actually not been
too popular here in the street, at least in this country.
Chairman Bliley. Dr. Leshner, according to a July 14 of
this year letter from Secretary Shalala to Ranking Member John
Dingell, she claims that buprenorphine can reach new groups of
opiate addicts while expanding the range of treatment options
that can be used by physicians. Do you agree with that?
Mr. Leshner. Yes, sir, I do.
Chairman Bliley. Thank you, Mr. Chairman. I do not have any
further questions.
Mr. Bilirakis. Thank you, Mr. Chairman.
Mr. Brown.
Mr. Brown. Dr. Leshner, good to see you, and Dr. Clark. Dr.
Clark, your testimony emphasized the testimony of the ancillary
services such as counseling. Comment on the bill's adequacy in
this regard.
Mr. Clark. We believe that there needs to be a psychosocial
support system. We believe that that can be put together with a
new system of care. But it is critical that these issues be
addressed. I don't believe that primary care physicians are in
the position to provide psychosocial adjuncts; however, with
proper training, with emphasis on encouraging primary care
physicians to use referral systems or to help develop or to
participate in the development of referral system, which SAMHSA
would be able to do, that these psychosocial adjuncts could be
created fairly easily. And so you would have the primary care
physician providing the medication, able to refer a patient to
psychosocial support systems.
One of the things that it is critical to recognize, that
medication without psychosocial support, without vocational
rehabilitation actually may not work as well as people believe.
And so we are encouraged by this legislation because it does
conceptualize a new delivery system, but that new delivery
system also needs to have some components fleshed out, and we
are perfectly happy to be working with the Congress to be able
to do that.
Mr. Brown. Thank you.
Dr. Leshner, what will States' reaction be to this
legislation, both State and local officials and elected
officials that work on drug policy and work on treatment
operations and all?
Mr. Leshner. I think that will depend on the individuals
within the State and which parts of the health system and the
drug addiction system they may be involved in. Positive, I
think if all of this is done well. As Dr. Clark suggests, it is
something that will have to be done with the States, not to the
States. So I think we will be working together in order to
develop the most effective techniques to use these medications.
Mr. Brown. Do we need changes in the legislation to
encourage that cooperation between or among local, State,
Federal?
Mr. Leshner. I really don't feel like I can comment on the
legislation or that part of it since that really is outside of
my purview. It is actually within Dr. Clark's purview. I do
believe that these are effective medications that can be used
in a very wide variety of settings.
Mr. Brown. Dr. Clark, would you respond to that in terms of
local, State, Federal cooperation if this legislation needs
some changes for that?
Mr. Clark. Yes, sir. And thank you, Alan.
Mr. Leshner. You are welcome.
Mr. Clark. As a practicing addiction psychiatrist and also
as the director of a center, it is important that we have good
care available to all citizens in America. So we need to work
with the States. There are some provisions. There is a
preemption provision in the legislation which contemplates a
transition period that will allow us to get good data, good
information, so that when States subsequently make their
decisions, they will make their decisions based on good science
and hopefully good information which we would be working with
the States to acquire.
So that is an important element. We want to make sure that
we do have this transition period, but we do have the
opportunity to bring good results so we can work with the
States so that they can see that this is indeed a medication
with good results and low diversion potential, because we are
also working with the DEA, and this will be something that we
hope they will adopt.
Mr. Brown. Thank you.
Mr. Chairman, thank you.
Mr. Bilirakis. I thank the gentleman.
I am gathering from your testimony and some of your
responses here that you are both supportive of the concepts of
the legislation; is that correct?
Mr. Clark. Yes, sir.
Mr. Bilirakis. I am not going to ask you if you are
supportive of me. As I understand it, there is no
administration position on the legislation?
Mr. Clark. That is correct.
Mr. Leshner. That is correct.
Mr. Bilirakis. I won't ask you if you personally support it
because it would be putting you in a spot. But everybody seems
to agree that it is significant that we take this in some way.
Mr. Brown and others have raised the point of the States, and
that certainly has been addressed, maybe not satisfactorily,
but State laws would be preempted. In other words, the States
could opt out. That was mentioned by one of the Senators, too.
Is that adequate? I'm not sure.
But, Dr. Clark, the letter, the famous letter of July 14
from Dr. Shalala, which is now a part of the record, did you
agree with that letter?
Mr. Clark. The letter came from----
Mr. Bilirakis. It is a very lengthy letter.
Mr. Clark. Very lengthy letter, very well written, and
since it came from Secretary Shalala, I, of course, support Dr.
Shalala completely.
Mr. Leshner. I agree with the letter.
Mr. Bilirakis. You do agree with it.
Mr. Leshner. I do.
Mr. Bilirakis. Dr. Clark is a psychiatrist. We have to take
that in consideration.
Doctor, please don't think I am trying to pin you down
here. The letter is a partial response to a series of questions
that Dr. Shalala set out in the letter and then respondes to.
In the partial response to number 13, she says, ``in our view,
to consign new treatment medications with enhanced safety and
less diversion potential solely into the existing methadone
clinic system would be a serious public health mistake.'' Do
you agree with that?
Mr. Clark. I agree with that.
Mr. Bilirakis. You do.
Dr. Leshner, you agree with that?
Mr. Leshner. Yes.
Mr. Bilirakis. Well, all right. I am not going to go into
any more here. I mean, we all agree that this is important.
Yes, reauthorizing SAMHSA is also very important. That is
something that this committee has done in the past, and there
is no reason to expect the committee would not do so again.
This piece of legislation can either move on its own, or it can
be made a part of SAMHSA when it is reauthorized. But in any
case, the legislation itself is significant as needed changes
might take place.
So I would hope that we can continue to work with both of
your groups in order to proceed further here. We have some work
to do with the minority, too, in that regard. Sounds like we
do.
Mrs. Capps.
Mrs. Capps. Thank you. I was unable to give a verbal
opening statement. I will submit mine for the record.
So I want to take this opportunity to thank our Chair for
holding an important hearing on a very serious issue, substance
issue. And thank you for being here as our witness to our
panel. And I am convinced that the use of buprenorphine is
going to be an important step for detoxification and
maintenance for those who abuse heroin, certainly a step in the
right direction. And it is also, I think, important to note
that detoxification and treatment are different things, and I
am convinced along with and heartened by the comments that our
Chairman just made that we have a job to do to reauthorize the
Substance Abuse and Mental Health Services Administration along
with this, and that might be a good pattern to follow.
It is my belief that there is evidence to substantiate that
substance abuse should be addressed in a comprehensive fashion
as part of an overall mental health policy. And I wish that it
were possible to treat substance abuse problems with a single
pill or dose. Unfortunately it is not that simple. Drug
addiction is often an intergenerational family, maybe even
community, issue, with future use by children of addicts a very
common occurrence and a pattern that I saw as a school nurse
over the course of a generation. In addition, inadequate
funding for treatment services is often a barrier to treatment
and prevention services.
And I want to focus your attention, if I could, on
demonstrations that some models that are available throughout
the country have proven to be effective. I know because one of
them is in my district. It is a fairly substantial, Robert Wood
Johnson Treatment, comprehensive program called Fighting Back,
completed 5 years and has been extended for 2 more, and it is
the model that I have in mind because it enabled the community
to come together with both private and public agencies in a
collaborative effort. Their symbol was an umbrella that had
counseling as one of the spokes, but it had a lot of other
spokes as well.
And my question to you is if we can use the chairman's
pattern of perhaps including this legislation in a
comprehensive reauthorization package for SAMHSA, is there--can
we point to evidence throughout the country of models that have
been and are comprehensive, but have established a track record
in this area?
Mr. Leshner. I am not a part of SAMHSA, we are a part of
NIH, but let me just say that we do have a range of models
throughout the country that have been demonstrated to be
effective. There is no question that substance abuse is a
manageable problem. The problem is that our strategy for
dealing with it comprehensively has to be as complex as the
problem itself. And I think, sadly, as you suggested, there
never will be a magic bullet. But we do have to have bullets in
that sense.
Mrs. Capps. So looking at this legislation as one piece of
a larger picture, shall we say, is that where you would like--
where we would perhaps effectively move?
Yes, sir.
Mr. Clark. We need to have more flowers in the garden.
Bullets I don't like. And with more flowers in the garden, I
think we can address the issue. And indeed SAMHSA is committed
to that. Our reauthorization does not need to be hooked up to
this particular piece of legislation, but this particular piece
of legislation needs to contemplate the existence of a service
delivery system that can help the primary care doc. No primary
care doc who is prescribing a medication is going to feel
comfortable if he or she does not believe that there is an
extra help out there, because--and I spent many years
delivering service to opiate-dependent individuals. I have
worked in free clinics, I have worked in methadone programs,
and I have prescribed buprenorphine in research protocols. And
I can tell you that it is a complex set of problems. And if we
are going to have a multifaceted strategy, we've got to have as
many flowers in the garden as possible. But we need a garden,
you just can't have a single flower waving in the wind.
Mrs. Capps. That is a good image. But tell me, before we
would get into the business of really getting behind something
like this which is complex and perhaps takes money up front to
get it going, how long we are sure that this is going to work?
Are there examples? Excuse me for running over my time.
Mr. Bilirakis. Please respond.
Mr. Clark. There are data that would suggest that this
would work. We are in the process of working with NIDA to get
more information. We think that this will work, especially if
it is a part of a larger comprehensive system.
Mrs. Capps. If I could just say in conclusion that every
piece of documentation we could have about success rates in a
comprehensive package I believe would really be useful.
Mr. Bilirakis. Doctor, you know that the legislation
requires onsite counseling and also sets up a referral process,
right? And that is what you are referring to. So that is
covered; maybe not adequately, but it is certainly contemplated
in the legislation, you would agree there?
Mr. Clark. Yes.
Mr. Mr. Bilirakis. Mr. Greenwood.
Mr. Greenwood. Thank you, Mr. Chairman.
This is a hearing about a very specific new potential
modality, and there has been a lot of discussion this morning
about effectiveness. I would like to ask a very broad question,
and that is, I don't know what the number is, but you can help
me with that in terms of the total dollars that the Federal
Government spends on treatment for substance abuse or drug
abuse? And that is done for a variety of substances in a
variety of modalities and variety of settings, variety of
components and so forth.
What I would appreciate hearing from you is, what is the
state-of-the-art of our measurement of the outcomes in these
various programs? A measurement of the outcomes. In other
words, how do in all of these myriad settings and modalities
and specific programs and so forth--a lot of money gets spent
on this very critical treatment purpose. I always have some
questions about how we measure what is working, what is not
working so we know how to constantly over time refine where the
funds go so that they are most effective. Could you respond to
that?
Mr. Leshner. Sure. There have been a number of outcome
measures that have been developed over the course of decades
actually that can help us evaluate the effectiveness of
individual programs, but also of the overall treatment system.
And there is a large body of research that demonstrates, first
of all, that the treatment of addiction is as effective as the
treatment of virtually any other chronic--relapsing chronic
recurring condition. Those treatment effectiveness rates range
in the 50 to 70 percent range, which is substantial.
Having said that, when we look at the effectiveness of drug
treatment, it is very important not just to look at drug use
per se. The goal of drug treatment is, of course, to reduce
drug use, but also to return the individual to productive
membership in society and the family and the community. And we
also have outcome measures that can be applied to that. And
again, I would say using those kinds of metrics, you see that
drug addiction treatment is quite effective treatment. It
doesn't mean it can't be better.
Mr. Greenwood. I appreciate it. What I heard you say is
that there are and there have been developed over decades
effectiveness measurement systems, and that they can be used to
measure a specific program's outcomes and they can be used to
measure the universe of all treatment efforts. But my question
really is, do we have in place any system--if there are 10,000
different programs that receive Federal funds in the country--
do we have any accountability system? Do we have any
requirement--for instance, it has been suggested to me that 1
percent of all treatment dollars, 1 percent of that total,
should be used by each program to collect data to apply it,
some kind of an outcomes measurement, and that data should be
resubmitted to the Federal Government so that we can over time
say, you are not doing a very good job, maybe you shouldn't be
refunded; you are doing an excellent job on a program-by-
program basis; or this modality seems to be working better than
that modality, so we want to fund that.
I am trying to get a sense from you as to the across-the-
board, with all of these billions of dollars that we are
spending, whether we have in place across the board feedback
loops that enable us to refine the system.
Mr. Leshner. That is sort of out of our domain. I will let
Dr. Clark answer that.
Mr. Clark. We don't have such a comprehensive system in
place. We have included some provisions for that in our
reauthorization. We believe that the changes proposed in our
reauthorization would create more flexibility for the States in
the block grant programs while creating a performance-based
accountability system for States in line with what you are
asking for us to be able to do. And we very much agree with you
with the need for such a performance-based accountability
system. We would very much like to be able to do that.
Currently we don't have that.
Mr. Greenwood. So you support the notion that we should
figure out a way--and I don't pretend that it would be simple--
to make sure that program by program, modality by modality,
setting by setting, we are constantly in the business of
measuring effectiveness so that we can do more of what is
working and less of what is not working?
Mr. Clark. As a physician, that is critical. As a
physician, it makes for not only an economically effective
system, but ethically effective system, enhances patients
rights. It also gives us the assurance that above all we are
not causing any harm.
Mr. Greenwood. If you have X number of dollars, and it
costs Y to do that, are you prepared to actually spend X minus
Y on treatment? Because the money that it would cost to create
the feedback loop doesn't come out of thin air. My sense is if
you spent a percentage point, you would end up over time using
that other 99 percent much more effectively than if you didn't.
Mr. Clark. I agree with you. We certainly believe that it
is within the province of the Congress to determine what that
percentage point should be. But it is critical that we have
resources available to answer the kinds of questions that
continue to pop up. So I agree with you.
Mr. Greenwood. Thank the panel and the chairman.
Mr. Bilirakis. I thank the gentleman.
Mr. Brown.
Mr. Brown. I have one more question for Mr. Clark about the
3-year preemption, because I think we need to think about that,
clearly about that. Are States locked into the 3-year
preemption? Can they opt out during the 3 years is your
understanding?
Mr. Clark. I actually have not seen the House version of
the DATA legislation, so I am not in the position to comment.
Mr. Brown. Should they be able to opt out?
Mr. Clark. I think we would want to work with the States so
that we could have an opportunity to see if this new system
that we are trying to facilitate can work. I would believe that
we do need an opportunity to see that this could work in
multiple jurisdictions. We need that opportunity.
Mr. Brown. But you say we should work with the States. And
I understand work with whomever, but it should--you think that
option should be there?
Mr. Clark. For the States to opt out?
Mr. Brown. Yes.
Mr. Clark. I think ultimately the decision is within the
province of the Congress. But I would like to see a system in
place, though, that we can determine whether this new system of
care works in as many jurisdictions as possible.
Mr. Brown. All right.
Mr. Bilirakis. I thank the gentleman.
If there aren't any further questions, we will release the
panel of doctors, including Dr. Vocci. Thank you very much not
only for being here, but for the great work you are doing for
all of our people.
Panel 3: Dr. Charles Schuster, Director of the Clinical
Research Division on Substance Abuse, Wayne State University,
accompanied by Mr. Otis Rivers of the State of Michigan,
citizen of the State of Michigan; Dr. Larry Alexander, Baylor
Medical Center at Irving; Mr. Robert E. Anderson, Director of
the Research and Program Applications, National Association of
State Alcohol and Drug Abuse Directors; Dr. Thomas Kosten,
Resident of the American Academy of Addiction Psychiatry, West
Haven, Connecticut; and Ms. Jenny Collier-McColl, Director of
National Policy, Legal Action Center here in Washington, DC.
Ms. McColl and gentleman, welcome. Thank you for being
here. Your written statement you have provided the committee is
already a part of the record. I will set the clock at 5 minutes
and hope that you can stay within that period of time, or at
least as close to it as you can.
We have a recess now. There is a memorial taking place at
11 for recently departed Representative Brown. I don't know
whether we can finish up by then or not, but we will do the
best we can.
Dr. Schuster, please proceed.
STATEMENTS OF CHARLES SCHUSTER, DIRECTOR, CLINICAL RESEARCH
DIVISION ON SUBSTANCE ABUSE, WAYNE STATE UNIVERSITY; ODIS
RIVERS, CITIZEN, STATE OF MICHIGAN; LARRY L. ALEXANDER, BAYLOR
MEDICAL CENTER AT IRVING; ROBERT E. ANDERSON, DIRECTOR,
RESEARCH AND PROGRAM APPLICATIONS, NATIONAL ASSOCIATION OF
STATE ALCOHOL AND DRUG ABUSE DIRECTORS; THOMAS KOSTEN,
PRESIDENT, AMERICAN ACADEMY OF ADDICTION PSYCHIATRY; AND JENNY
COLLIER-McCOLL, DIRECTOR OF NATIONAL POLICY, LEGAL ACTION
CENTER
Mr. Schuster. Thank you very much. I am representing today
not only myself, but the College on Problems of Drug
Dependence, which is the oldest and largest professional
organization devoted to the study of drug abuse. And I happen
to be privileged to have been elected the president of that
organization, and they have asked me to express their opinion
as well as my own today.
I appreciate the opportunity to appear before this
subcommittee to discuss the Drug Addiction Treatment Act in an
open forum, because I think it important legislation that must
be considered in a very thoughtful manner.
I am not going to burden you again with the statistics on
heroin abuse in this country. You have heard them over and over
again, over 800,000 people addicted to heroin and less than
200,000 in treatment in 1998. What concerns me the most,
however, from the Federal statistics is the age of initiation
of heroin use has fallen from 27 years of age in 1988 to 18 in
1996. I can attest to that on a local basis in the Detroit area
where we have our treatment programs and we see that as well.
So I think that it is very important that the committee is here
today to consider the Drug Abuse Treatment Act, to address this
very important problem of heroin addiction particularly as it
is affecting our youth.
Now, as has been stated, one of the major advances that has
been made in the last several years is the development of
buprenorphine in the treatment of heroin addiction. The
National Institute on Drug Abuse, which was I was privileged to
serve as the director of it from 1986 to 1992, has established
in many, many clinical trials its safety and its efficacy. I am
currently using it in a large treatment research project and
have been very impressed not only with its effectiveness, but
as well with its acceptance by patients who might have been
reluctant to enter a methadone treatment program.
Now, I also direct an opiate maintenance treatment program
which uses both methadone and LAAM. Tragically, at least in
part because of the special regulations requiring attendance in
the methadone maintenance clinic 6 days per week, you have to
come every single day to get your methadone at least for the
first months. Many people who are working find this cumbersome,
particularly if they live a long distance away from treatment
programs. Because of the ``not in my backyard'' phenomena,
these programs are very widely dispersed. Many also have
expressed the fear that being seen entering a methadone
maintenance treatment program may jeopardize their employment
or their standing in the community.
Clearly, many of the witnesses have said that we must
address the issue of the stigmatization of methadone-maintained
individuals in the programs that dispense this medication. It
is absurd that this effective medication is a stigmatized as it
is. This stigmatization, I think, is in large part the reason
why we have so very, very few methadone maintenance treatment
programs in the United States. Nowhere does the NIMBY phenomena
operate more insidiously than in the reluctance of communities
and even whole States to accept the establishment of new
treatment programs employing methadone and LAAM.
Now, alternatives to methadone which are not subject to the
draconian regulations that are in place for methadone and LAAM
and the stigmatization, other medications which may escape
this, I believe, is of great importance in our efforts to bring
in large numbers of heroin addicts who are either unable to
enter treatment because the clinics are filled, or they are
reluctant to enter treatment as it is currently offered. I
believe the buprenorphine will reach opiate addicts who are
currently unable or resistant to enrollment in opiate
maintenance treatment programs that use LAAM and methadone.
Now, as you are aware, I think there are a number of
important safeguards in the legislation that has been proposed.
First of all, the Drug Abuse Treatment Act would allow
physicians to prescribe narcotic drugs which are controlled
under schedule IV or V of the Controlled Substances Act. I will
repeat what has been said previously, and that is the
Controlled Substances Act ranks medications in terms of their
abuse potential. Schedule V means that it is very low abuse
potential. The issues of diversion, particularly when naloxone
is added to buprenorphine, I do not believe constitute a major
issue.
This legislation would make it possible for qualified
physicians to prescribe buprenorphine to opiate-dependent
patients. I want to emphasize something else. That is that I
think that there are several organizations, the American
Society for Addiction Medicine and as well the addiction
psychiatry group that Dr. Kosten represents, that can assure us
that physicians who would be prescribing buprenorphine would be
well aware of the fact that many of these individuals do need
psychosocial treatment and would have systems in place for
proper referral with this.
Now I will skip to the bottom line here because of time,
and the other points that I wanted to cover are already in my
written testimony. But I want to make it clear that I think
that we need bold and innovative new treatment programs and
plans for the country. We have got to break out of the mold
that currently impedes the use of buprenorphine and LAAM. We
are not allowed to make good clinical decisions because of the
regulations that govern these treatment agents. I think it is
this act may very well be the first step in breaking out of
that mold and applying bold and innovative new treatment
approaches to problems of addiction.
Now, I can talk all day.
Mr. Bilirakis. Please summarize Doctor.
Mr. Schuster. I can talk all day about this because we have
been working on the problems of development of buprenorphine
for the treatment of heroin addiction for over 20 years. So we
have a lot of information about this. But I think that I would
like to ask the Chair to allow someone who is perhaps even
better qualified than I am to speak about this. I would like to
introduce a patient who is a participant in the NIDA treatment
program that I direct at Wayne, and I think his experience is
an ideal example of the effectiveness of buprenorphine as a
treatment medication for heroin addiction. I would like for him
to describe to you the experience which he has had with
buprenorphine which has prompted him to appear before us today.
[The prepared statement of Charles Schuster follows:]
Prepared Statement of Charles R. Schuster, Director, Clinical Research
Division on Substance Abuse, Wayne State University
My name is Charles R. Schuster. I am a Professor of Psychiatry and
Behavioral Neurosciences at the Wayne State University School of
Medicine and the Director of the Research Division on Substance Abuse.
From 1986 to 1992, I served as the Director of the National Institute
on Drug Abuse/NIH. Prior to that I directed the Drug Abuse Research
Center of the University of Chicago from 1972 to 1986. I am as well the
President-Elect of the College on Problems of Drug Dependence (CPDD)
which is the oldest and largest professional organization of drug abuse
researchers in the world. I am appearing here today as an expert
witness on the pharmacology of medications for the treatment of
addictive disorders and as well representing CPDD and the myriad of
drug dependent individuals who are sorely in need of safe, effective,
affordable treatment. I appreciate the opportunity to appear before the
Subcommittee to discuss the Drug Addiction Treatment Act in an open
forum because I believe that such important legislation must be
considered in an open and thoughtful manner.
A major impediment to our ability to treat the problems of
addiction is that we have only a limited number of pharmacotherapies
for heroin addiction and none that are generally useful for the
treatment of cocaine addiction. According to the 1999 National Drug
Control Strategy publication, there are approximately 810,000 chronic
heroin abusers in the United States. Unfortunately, a survey conducted
by the American Methadone Treatment Association during the last quarter
of 1998 revealed that only 180,000 people are enrolled in licensed
methadone maintenance programs throughout the country. Among youth, the
1997 National Household Survey on Drug Abuse found that the mean age of
heroin use initiation declined from 27.3 years in 1988 to 18.1 in 1996.
Given the magnitude of heroin addiction in this country, we need
innovative and bold approaches for the management of this disease. I am
pleased to have been invited to testify before this Subcommittee on
Health and the Environment of the House Committee on Commerce to
present my views on why we believe that the passage of the Drug
Addiction Treatment Act of 1999 is important to address this problem.
One of the major advances that has been made in the past several
years is the development of buprenorphine for the treatment of heroin
addiction. The National Institute on Drug Abuse (NIDA) has sponsored a
number of clinical trials, which have established buprenorphine as a
safe and effective medication for the treatment of heroin addiction. I
am privileged to have had a minor role in the development of this safe,
effective treatment. I am currently using it in a large treatment
research project and have been very impressed not only with its
effectiveness, but as well with its acceptance by patients who would
have been reluctant to enter a methadone treatment program.
Tragically, at least in part because of the special regulations
requiring attendance at a methadone maintenance clinic six days per
week, many individuals who are working are loathe to come in for
treatment. Further, many have expressed a fear that being seen entering
methadone maintenance treatment programs may jeopardize their
employment and standing in the community. Clearly we must address the
stigmatization of methadone maintained individuals and the programs
which use this treatment modality. It is absurd that this extremely
effective medication has been so badly stigmatized. In large part this
stigmatization has been responsible for the fact that we have seen very
little growth in the number of treatment programs providing methadone
over the past decade despite the obvious need. Nowhere does the ``Not
In My Backyard'' phenomenon operate more insidiously then in the
reluctance of communities and even states to accept the establishment
of new treatment programs employing methadone and levoacetyl methadol
(treatment medication for opiate dependence also known by the tradename
ORLAAM) as maintenance medications.
Alternatives to methadone which are not subject to such draconian
regulation and stigmatization is of great importance in our efforts to
bring in the large numbers of heroin addicts who are either unable to
enter a treatment program because the clinics are often filled or they
are reluctant to enter treatment as it is currently offered. Thus,
buprenorphine may reach opiate addicts who currently are unable or
resistant to enrollment in opiate maintenance programs that use ORLAAM
and methadone. I have many letters in my desk from patients whose lives
have been turned around by the buprenorphine treatment we have provided
them. I am accompanied by a patient who will shortly describe how
buprenorphine has helped him to gain control over his heroin addiction
problem.
As you are aware the Drug Addiction Treatment Act of 1999 would
allow physicians to prescribe narcotic drugs which are controlled under
Schedule IV or V of the Controlled Substances Act for the maintenance
of opiate dependent persons. Because of the relative safety and lower
abuse potential of buprenorphine it has been placed in Schedule V of
the Controlled Substances Act. Thus, this legislation would make it
possible for qualified physicians to prescribe buprenorphine to opiate
dependent patients. I want to emphasize that under the bill, only
physicians who by virtue of their training and experience are
determined to be qualified by the Department of Health and Human
Services would be allowed to dispense Schedule IV or V narcotics for
this purpose. In part this expertise is being able to determine who
needs specialized rehabilitative and psychotherapeutic services in
addition to treatment with a medication. Obviously, those who are in
need of additional rehabilitative services must be referred to existing
substance abuse treatment programs or other specialists capable of
providing such services.
I cannot express how important this legislation will be for those
of us who are attempting to bring the very best in treatment to
individuals who have been ensnared by heroin addiction. I see young
people everyday who are in need of medications to ease their need for
heroin so that they can become invested in rehabilitation activities
that can return their life trajectory to a normal, productive and
fulfilling course. Currently the available medications, methadone and
ORLAAM are extremely useful but ensnared in regulations that grossly
limit their potential effectiveness. Having a safe, effective narcotic
preparation that could be used by qualified physicians for the
treatment of opiate addiction that is unfettered by the methadone
regulations would be a major advance in our ability to provide badly
needed services in a cost effective manner. It should be noted that
this bill has a number of provisions that preclude physicians from
becoming ``script docs.'' No physician could have more than 40-
buprenorphine-maintenance patients.
Furthermore, the bill explicitly states that this program of office
based narcotic maintenance treatment would be evaluated over a three
year period to determine whether it expanded effective treatment
capacity without adverse consequences to the public. If the program did
not meet these goals then it would be discontinued. Finally, the bill
provides for earlier termination of this program if it is found that
the narcotic drugs dispensed by physicians are being diverted into the
illicit drug trade. It is my understanding that this bill provides that
states can write more restrictive legislation precluding physicians
from using Schedule IV and V medications for opiate maintenance therapy
if states deem it necessary.
I must also stress that although buprenorphine is a major
advancement for the treatment of opiate addiction, there are new
medications on the horizon that may even be safer and more effective.
My group at Wayne State University is part of a major NIDA sponsored
research program for such medication development. Unfortunately, the
cumbersome methadone federal regulations as well as the state and in
some instances city regulations of methadone maintenance programs have
acted as a great disincentive for pharmaceutical companies to invest in
this area. Academic researchers cannot bring a new medication to market
without the help of pharmaceutical companies. The problems associated
with the introduction of ORLAAM in 1993 for the treatment of opiate
addiction is a textbook case of how the state and federal regulations
make it impossible for a pharmaceutical company to realize a profit on
their investment for medications for this indication. It took for
example; three years after the FDA approved ORLAAM before the necessary
regulations were written in states such as California to allow its use
for the treatment of heroin addiction. Many states have still not
written the enabling legislation.
These barriers were addressed in a meeting convened by Senators
Levin, Moynihan and Kerry in May of 1997. At that meeting, in which I
participated, pharmaceutical companies specifically mentioned the
federal and state regulations governing opiate maintenance therapy as a
major disincentive for their developing medications to be used for this
indication. The Drug Addiction Treatment Act of 1999 might serve to
remove this disincentive for pharmaceutical companies to develop safe,
less addictive, effective medications for the treatment of opiate
addiction. I believe that in the long term this would be one of the
most important effects this legislation would have.
The need for innovative approaches to the problems of addiction
demands that we take bold actions. Daily, I see the victims of
addiction, the patients, their families and the Michigan communities
that are ravaged because of crime associated with drug abuse. Research
has shown that treatment is the most cost-effective way to decrease
this problem. The Drug Addiction Treatment Act of 1999 can
significantly expand treatment access. On behalf of the College on
Problems of Drug Dependence, we strongly urge you to support this
legislation.
I would now like to introduce a patient who is a participant in a
NIDA sponsored heroin addiction research treatment program that I
direct at the Wayne State University School of Medicine. His experience
is an ideal example of the effectiveness of buprenorphine as a
treatment medication for heroin addiction. I would like for him to
describe to you the experience which he has had with buprenorphine
which has prompted him to appear before you here today.
Mr. Bilirakis. Without objection the Chair will yield a
couple minutes to Mr. Rivers.
STATEMENT OF ODIS RIVERS
Mr. Rivers. I am Odis Rivers. I am a recovering heroin
addict.
Mr. Bilirakis. I know this has got to be tough for you sir.
Just do the best you can. Maybe we can get some water for Mr.
Rivers.
Mr. Rivers. I am a recovering heroin addict enrolled in a
treatment research project at Wayne State University School of
Medicine. I have been addicted to heroin since 1970. I am a 3-
year veteran of the U.S. Army. I served overseas in South
Korea. I became an addict when I returned from the Army in
1970, the same year I was diagnosed with diabetes. I had made
many attempts to overcome my heroin addiction, but have always
relapsed. Today I am proud to say that I have been drug-free
for over 6 months and feel increasingly confident that I can
stay that way.
The medication, buprenorphine, that I have been received at
the Jefferson Avenue Treatment Research Program has been one of
the important parts of my recovery. Six months ago when I came
to the research clinic, I had been separated from my wife, and
over the 29 years that I have been on heroin addiction, I had
most--I had lost the respect of my family. Today I am back with
my wife, and I am looking forward to making up all the time
lost with her when I was addicted. I am very lucky to have a
family who has seen that I am making an attempt to turn my life
around. I am looking to have their respect, and I can be a big
brother again to my sister.
Mr. Schuster. Mr. Rivers is the most articulate person I
know, and I should point out one thing; that is that because of
his diabetic condition, he sometimes has problems. But
interestingly enough, everything that is submitted here in the
written record was dictated to me by Mr. Rivers. And I think
one of the things that--he said this to me last night at
dinner--is that he has gotten back together with his wife and
is looking forward to the kind of things that he hasn't been
able to do with her during the years that he was addicted to
heroin, and that he can be a big brother to his sister. And I
can't even say that without getting a little weepy.
Mr. Rivers. Okay. You know, I feel I just got to start all
over again, you understand that with my diabetes, and this
morning and stuff I--with the scheduling and everything and my
medication----
Mr. Bilirakis. Leave it to the Congress.
Mr. Rivers. [continuing] with the medication that I have
been taking in the program and everything has made a dramatic
big change in me, and a lot of things have happened, and, I am
here to just to, you know, say, well, hey, thanks.
Mr. Bilirakis. Thank you, Mr. Rivers. And we may have a
question or two for you, if you don't mind, when we get to that
point. But in the meantime we will move on to Dr. Alexander.
Mr. Rivers. Okay.
[The prepared statement of Odis Rivers follows:]
Prepared Statement of Patient at the Jefferson Avenue Treatment
Research Program, Department of Psychiatry and Behavioral Neuroscience,
Wayne State University School of Medicine
I am a recovering heroin addict enrolled in a treatment research
project at the Wayne State University School of Medicine. I have been
addicted to heroin since 1970. I am a three year veteran of the U.S.
Army where I served overseas in South Korea. I became addicted to
heroin when I returned from the army in 1970 the same year that I was
diagnosed with diabetes. I have made many attempts to overcome my
heroin addiction but have always relapsed. Today I am proud to say that
I have been drug free for over 6 months and feel increasingly confident
that I can stay that way.
The medication, buprenorphine, that I have received at the
Jefferson Avenue Treatment Research Program has been one of the most
important parts of my recovery. Six months ago when I came to the
Research Clinic I was separated from my wife and over the 29 years that
I was a heroin addict I had lost the respect of my family. Today I am
back with my wife and am looking forward to making up for all of the
time I lost with her when I was addicted. I am also very lucky to have
a family who has seen that I am attempting to turn my life around. It
feels good to have their respect and I can be a big brother again to my
sister. That means a lot to me and I know having this respect will help
me in my recovery.
I want to emphasize that I know that I am not out of the woods.
Heroin addiction is a disease just like my diabetes. Yes, I know that I
brought on my heroin addiction, but I didn't think I would ever get
addicted when I first tried heroin. It just sneaks up on you and
suddenly you realize that it has taken over your life. Since I entered
treatment and began taking the medication buprenorphine I have not
suffered from withdrawal symptoms or craving for heroin. I also do not
feel ``drugged'' by this medication. It just makes me feel OK and able
to think about other things besides getting high on heroin.
I feel about buprenorphine like I do about the insulin I take
twice a day for my diabetes. It has saved my life. Now I want to make
it clear that the counseling and groups I attend at the treatment
program are also important to me. It's the entire package that has
helped me, but the buprenorphine has made it all possible. Without it I
would still be scared of withdrawal sickness and the craving for heroin
that gives you. With it I know that even if I take heroin I won't get
much of an effect because my doctors tell me it is a heroin blocker. So
I feel straight, do not crave heroin and am able to work, be with my
wife and once again get back with all of my family. I only hope that
this medication can be made available to many more people like myself
who foolishly thought that they could play with heroin and ended up
having it take over their lives. That is why I have come here today to
say please make this drug available to other heroin addicts who may
benefit from it as much as I have. Thank you.
STATEMENT OF LARRY L. ALEXANDER
Mr. Alexander. Mr. Chairman and subcommittee, thank you
very much for giving me the opportunity to come speak with you
today. My written testimony has already been inserted into the
record, and it gives some illustrations about the new faces of
heroin. I would like to tell you a couple of other stories,
because as an emergency physician I see all types of people. I
see all types of problems. I see people at their best, and most
often at their worst. And being in the emergency department, we
catch people who fall through the cracks for all types of
reasons.
I have been a physician now for 10 years. Throughout my
training and medical school and residency, I learned about the
addiction process through seeing it through the emergency
department. We are not really taught that much about it in
medical school. But I had such an experience with it during
that training period that I didn't want to deal with it
anymore, so I chose to go back home to Dallas, and I picked a
suburb thinking I am not going to have to deal with this
anymore. The suburbs are safe. And it was for a couple of
years, but then things changed.
We think about people who use heroin. We also think about
an adult, someone who has matured in their life, someone who is
making decisions, albeit the wrong ones. We don't tend to think
about it being our teenagers, but that is what I see. I am a
member of the American College of Emergency Physicians, it
consists of 20,000 physicians across the country who practice
in emergency rooms, and my colleagues all across the country
have these same types of stories.
We have seen an increase in the number of younger people
using heroin, and not only using, but dying. As I illustrated
in my written testimony, the youngest person I have seen was 12
years old. He came in after school by ambulance not breathing.
His mom got there just about a minute after the ambulance did,
as we were resuscitating him. And it is always a very tough
call as to whether or not to allow a parent into the emergency
department when you are resuscitating a child. And in middle of
all this, I turned around, and she was tapping on my shoulder,
and she said, I want my other children to see this. She asked,
do you have a problem with it? It is really frightening as a
physician to be taking care of a dying child in the first
place, but when you know you have the parents watching over
your shoulder, you just freeze inside. I said, ma'am, I don't
know that they need to see. Then she says, if I lose him, they
need to know why.
So she brought her 9-year-old and her 11-year-old son in to
watch us try to resuscitate her 12-year-old son, and in this
instance we got him back. Later in the afternoon I went up to
the ICU. He was awake. I finally got the story out of him. He
was walking home--and this story I don't truly believe--but he
was walking home, and he found a capsule on the street. In
Texas, our heroin comes most often in the form of ``chiva,''
which is a brown powder most often packaged into a capsule.
They open the capsule, you sprinkle the powder on something,
you either smoke it directly, melting it, or you mix it with a
joint, you mix it with some cocaine, and you smoke or snort it.
He informed me that he found this brown capsule and he smoked
it.
A 12-year-old is not going to automatically pick something
up and smoke it. This child had seen that maybe even done it
before.
I have also myself been personally physically abused by
parents when I confront them with a child who is using. There
is such a denial process in this country, especially in the
suburban areas, that my child cannot do this, my child would
not do this. These children get into the wrong crowds. They
hear about something in a party that sounds really exciting,
sounds fun, sounds like it makes me feel really good, and they
will try something.
This new, improved form of heroin is so much stronger than
what we have had the past and so much easier to use and doesn't
have the stigma of heroin in the past because the needles are
not usually involved initially, so that people begin to use
many time, not even knowing that chiva or Columbian white is
heroin. And all it takes is one single use to kill. If it
doesn't, more often than not you are addicted for the rest of
your life. These kids lose their lives before they even have a
chance to live their lives.
In closing, I would just like to say when I graduated from
medical school, I had this burning ambition to change the
world. I think we as an American public want to change the
world, especially when it comes to this issue. We want there to
be one answer for this problem. But as many people who are
involved in this problem, there are as many answers.
All I can do as a physician now that I have matured and
grown up some is I can change the world by saving one life at a
time, and I think that that is what this legislation will allow
us to do, get the opportunity to make a difference one life at
a time based on an individually structured program that
networks everything, all of our resources, together. Thank you.
[The prepared statement of Larry L. Alexander follows:]
Prepared Statement of Larry L. Alexander, baylor Medical Center at
Irving
My name is Larry Alexander. I am an emergency physician and I work
in three different emergency departments in the Dallas area, one inner
city trauma center and two different suburban hospitals. I have seen
and continue to see first hand, sometimes almost on a daily basis, what
drug use and abuse are doing to young people in this country. I want to
share some of my experiences with you.
As an emergency physician, I am trained to evaluate and treat any
and all patients who present to the emergency department with all kinds
of health problems and situations. Even with my training, I was not
totally prepared for what has become an epidemic of drug use and abuse
by the young people in my area as well as in other parts of the
country.
I saw many people using and dying of drug use during my medical
school and residency training years. In fact, these experiences helped
me to choose to work in the suburban area of Dallas in an attempt to
get away from this type of problem. And for almost four years, I didn't
see much except the things we all seem to accept as a part of American
culture now--namely alcohol abuse and the occasional marijuana and
cocaine use. That changed in late 1996.
At my hospital in Plano, a northern suburb of Dallas, we had our
first heroin overdose. This was a young woman in her twenties who said
that she was a heroin user of many years. She didn't die, but she came
close. Over the next several months, we began to see an occasional
overdose of heroin. By March 1997, we were seeing heroin overdoses with
what I would call alarming regularity.
My first heroin death was in March 1997. By June we had
approximately 30 overdoses and 4 deaths. On July 7, 1997, I had an
experience that forced me to become personally as well as
professionally involved in this epidemic. I was working the night shift
when two teenaged boys ran up to the ambulance doors screaming for
help. ``Help us! He's not breathing!'' I rushed out to find a young man
lying in a black Suburban not breathing. I started CPR and we carried
him into the emergency department. The two young men left without even
telling us the name of the patient.
He died after thirty minutes of resuscitation. I notified the
police and they drove the streets of Plano until they found the
Suburban at a party where drugs were being used. They brought the boys
back to the emergency department and I got them to tell me the young
man's name. I then had to call his parents at 3:18 a.m. and ask them to
come to the emergency department. ``Mrs. Scott? This is Dr. Alexander.
I'm calling from the ER. Do you have a 17-year-old son by the name of
Wesley?'' There is always a pause and then in pure panic, ``Is he all
right? Is he O.K.? Is he alive?'' This is probably the hardest part of
my job--telling parents that their child has died. I can't do it over
the phone. I feel that they deserve to hear it from me in person. ``Can
you come to the ER right away? Wesley is here and is in critical
condition. I need you here now and so does he.''
My anger at this situation led me to begin to talk to all young
people coming to the emergency department for drug related situations.
Over the next several weeks I took care of 10-15 patients between 12-19
years old who had overdosed on heroin. One patient in particular stands
out. Jason was an 18-year-old who came in as an overdose of a mixture
of heroin and cocaine. He was not breathing when his father discovered
him. By the time he arrived at the hospital, the paramedics had gotten
his heart going and he was barely breathing after getting the drug
Narcan en route to the emergency department. We admitted him to the ICU
in a coma.
Two days later Jason woke up. Shortly afterwards, he began to
seize. His temperature was 108 degrees. He had developed pneumonia in
both lungs from vomiting while unconscious. Between the coma and the
seizure, Jason suffered severe brain damage. On October 2, 1998 Jason
turned 20 years old. He lives in a nursing home. He can't talk. He has
a hole in his throat where he is hooked up to a ventilator at night in
case he forgets to breathe. He has a hole in his stomach as a feeding
tube because he can't eat. He wears diapers because he can't control
his bowels or bladder. He is confined to a wheelchair because his arms
and legs are wasted and contracted like a person with cerebral palsy.
He may live to be 70 years old. He will be like this every day that he
lives.
By September, we had another rash of heroin overdoses resulting in
3 deaths in 2 weeks. I was approached by the school district in
October, at the request of students, to come to the schools to talk to
the students about the realities of drug use. My emergency department
talks had evidently gotten to somebody. I started giving very graphic
talks-- telling stories about the realities of what happens when you
use drugs. I even dressed the dress and talked the talk--no dry,
unemotional medical terms, so that I knew the young people would
understand me. My description was so graphic that students would
sometimes faint and many left the assemblies to vomit.
In November I took care of a 19-year-old young man who overdosed on
heroin for the third time. He came in once with friends and twice by
ambulance not breathing. I took care of him all three times. Each time
he wouldn't believe me when I told him he was basically dead because he
didn't remember it. He laughed it off saying, ``What do I care if I
die? I'm doing it to myself, right?''
Now I know that you all understand that all life is precious and
that no one life is more important than any other, but it has been a
shock to my suburb as well as others around the country to find that
young people who have all the necessities and many of life's extras
would wind up using heroin--some of them even dying from it. The drug
heroin itself has changed in the past 25 years. No longer is it
necessary to inject it with a needle. Heroin now is new and improved.
It comes in a powder form that can be smoked or snorted. It is much
more potent and much much more addictive and deadly than ever. It even
has a new name--chiva in the South and West and China or Colombian
white on either coast.
I travel all over the country now talking with young people and
their parents about drugs and drug abuse. I hear the frustration from
both users and their families about the options for treatment and
rehabilitation currently available. This drug is so addictive that many
individuals can't and won't quit. I have a colleague whose son started
using heroin at 18. He was a national caliber debater with many awards.
He overdosed twice and survived. He ran away from home by stealing his
mother's car. He was put into a methadone program and got up to 90mg a
day, a very high dose, and was still overshooting--using methadone in
the morning and heroin in the evening. She had him arrested not once,
but twice, to get him off the streets. He went to a prison rehab
program for 10 months. When he got out, he was clean for 4 months then
relapsed. She got him into a treatment program but he checked himself
out, legally, because he was over 16. He is now in a treatment facility
in California, as far away from his friends and home situation as she
could afford to send him. She often tells me she quit counting up the
dollars she spent on him before and after insurance ran out at
$100,000.
Recently we lost Mark Tuinei, a former Dallas Cowboys football
player to heroin. Mr. Tuinei was 6 foot 6 inches tall and weighed 324
lbs. He was in great physical condition. He died in a matter of minutes
from shooting up with heroin. His friends saw him do it and saw him
quit breathing. They did mouth to mouth resucitation for a few minutes
and got him breathing again. He was still groggy so a friend drove him
home and left him in his car to sleep it off. He died in his sleep by
drowning in his own vomit. Mark was a community leader and role model
for young people but even the drug seduced him and he paid for it with
his life. He was 39 years old and had had a life. Many of the young
people who become addicted or die never even have a chance at a life.
I would like to share with you something that I always share with
the young people I talk with--the experience of what it feels like to
die from a heroin overdose.
You're at a party and somebody offers you something new. ``Come on.
Try it. It's great stuff!'' ``What is it?'' ``Oh, it's some chiva. Come
on take a hit off this joint. It's some pot and chiva mixed.'' So you
take a hit. Nothing happens. You take another. Then you feel it. You
begin to feel this warm rush all over. You get a little light headed.
You start to float off. For a few minutes maybe an hour, you feel
great--relaxed, mellow. Then things began to change. You don't feel
right anymore. You start to walk towards a chair but you don't make it.
Your arms and legs feel like they weigh a ton. You try to speak to get
some one's attention but you can't talk because your tongue feels heavy
and thick. The lights seem too bright, the music too loud, the smells
too strong. Heroin makes your senses more acute for a period of time.
You sit down on the floor, your back against the wall. Your head droops
forward. You begin to get nauseated. Heroin is a very powerful narcotic
and as such causes severe nausea. Normally when you get nauseated, you
vomit and feel better. But with heroin that doesn't happen. Heroin
blocks your gag reflex so that when you start to vomit, your epiglottis
doesn't fall down to protect your airway. Instead, your stomach
contracts and empties your stomach contents into your throat where it
all slides down into your lungs. In a few minutes, your lungs fill up
and you drown in your own vomit, right in front of everybody. Nobody
knows you died because they didn't see anything happen. Or, you might
get lucky and die within the first few seconds of using because the
heroin was so strong it shut down the breathing control center in your
brain.
This is what heroin does to anyone who uses it. It has become a
very commonly abused drug by our young people. It is very addictive and
very deadly. We need to fight back using every means possible. We need
to educate our young people and hope that they will choose not to use.
Once an individual uses, we need the best possible means to prevent
continued use, to provide the best rehabilitation available. We have to
make a difference. Drug abuse destroys lives, families, friendships,
opportunities, and our very future. We have to fight back because our
young people, our children ARE our future. Thank you.
Mr. Bilirakis. Thank you so very much, Dr. Alexander.
Mr. Anderson.
STATEMENT OF ROBERT E. ANDERSON
Mr. Anderson. Good morning, Mr. Chairman, members of
committee. I am Bob Anderson. I am the Director of Research for
the National Association of State Alcohol and Drug Abuse
Directors, or NASADAD. NASADAD is the association that
represents the agencies in each State that are responsible for
putting in the alcohol and other drug treatment and prevention
systems. The States provide on their own about two-thirds of
all the funding for the drug and alcohol programs out there, so
they are financially very deeply involved.
Our members are also the agencies that are responsible for
assuring that the services provided are of high quality.
In 1997, our members reported over 1.8 million admissions
into the treatment system that they manage, including an over
230,000 opiate addicts. And we are pleased to be at this
hearing today with our Federal partners and other stakeholders
to actively support the introduction of and use of new
medications in the treatment of addictions.
We are committed to expanding treatment options and
availability of treatment. NASADAD and its members have
participated in a series of NIDA forums designed to share
information and facilitate discussion on the research and
properties of buprenorphine. And in June of this year, Drs.
Leshner and Vocci of NIDA came to our annual meeting and sought
input from us and facilitated discussions on the induction and
effective use of buprenorphine. We have also consulted with Dr.
Clark from the Center for Substance Abuse Treatment and Dr.
Vereen of ONDCP on this matter.
NASADAD strongly agrees with those Federal officials that
the gap between treatment need and treatment availability is
unacceptably large, the treatment wait time must be reduced,
and the treatment outcomes must be improved.
I have some statistics that we will skip over because they
are in my written testimony.
I want to spend just a minute talking about our experience
with opiate-dependent clients. Individuals with an addictive
disease when the agent is heroin, in our experience, need a
comprehensive treatment approach because the disease itself has
biological, psychosocial and purely social aspects. And while
medications are essential to many individuals that are opiate-
dependent, successful recovery is often tied to counseling and
other supportive services designed to motivate clients, help
them make difficult life-style changes, because heroin
addiction does completely subsume the entire individual. And
those services are on a relatively long-term basis if we are
going to maintain recovery.
Case management services are also very, very important to
help an individual access other forms of health care, find
housing, and secure and maintain employment.
One of the issues always of importance to the States is
cost. In the drug and alcohol treatment field, the States bear
the major portion of costs. Methadone costs between 30 and 60
cents a day. The longer-lasting LAAM costs about $4 a dose, but
you don't need it every day. It is estimated that buprenorphine
for a 36-hour period will cost about 8 to $10. About 70 percent
of the cost of methadone treatment is now borne by the States,
and we think that will be the case with buprenorphine as well.
So our concern is, number 1, how is that medication going to be
paid for; and No. 2, the preemption of State regulations and
laws around this subject for a 3-year period is very, very
difficult to accommodate since the States have the
responsibility for the licensure and authority around that
issue.
Thank you for your attention to this very, very important
matter. We are supportive of increasing treatment options. In
any way that we can, we would like to.
[The prepared statement of Robert E. Anderson follows:]
Prepared Statement of Robert Anderson, Director, Research and Program
Applications, National Association of State Alcohol and Drug Abuse
Directors
introduction
My name is Robert Anderson and I am the Director of Research and
Program Applications for the National Association of State Alcohol and
Drug Abuse Directors (NASADAD). NASADAD represents State Alcohol and
Drug Abuse Agencies that have vast authority and responsibility for the
prevention and treatment of alcohol and other drug abuse.
Responsibilities of Single State Alcohol and Drug Authorities
NASADAD's members have considerable experience in public health
issues related to the treatment of opiate dependent persons. In
addition, State Alcohol and Drug Abuse Agencies are responsible for all
aspects of administering a $4 billion public alcohol and drug abuse
prevention and treatment system including certifying professionals,
accrediting treatment programs, contracting with community based
providers, analyzing data, and monitoring performance. In FY'97, State
Alcohol and Drug Abuse Agencies reported treatment admissions of over
1.8 million including 232,755 individuals with opiate addiction. Here
are breakdowns of that number by several States: California: 63,847;
New York: 26,049; New Jersey: 17,581; Michigan: 8,305; and Virginia:
4,432.
NASADAD's members have front line responsibility for assuring the
quality and effectiveness of prevention and treatment services. States
also play an important role in financing services. Of the $4 billion
public alcohol and other drug treatment system administered by State
Alcohol and Drug Abuse Agencies, Federal resources account for only one
third of the dollars, with States contributing or leveraging the
balance. In addition, States are also responsible for paying for the
bulk of medications used to treat opiate dependent persons.
overview of issues
Federal-State Partnerships
NASADAD and its members work closely with the Office of National
Drug Control Policy (ONDCP) and various agencies of the Department of
Health and Human Services (DHHS) including National Institute on Drug
Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism
(NIAAA), the Substance Abuse and Mental Health Services Administration
(SAMHSA), and the Food and Drug Administration (FDA). We are pleased to
be at this hearing today with our Federal partners and other
stakeholders and to pro-actively support the introduction and use of
new medications in the treatment of addictions.
In particular, we would like to acknowledge and commend the
important role that both NIDA and SAMHSA have played respectively in
the research and policy discussions related to buprenorphine and its
potential introduction to the field.
NASADAD and its members have participated in a series of NIDA
forums designed to share information and facilitate discussion on the
research and properties of buprenorphine. Most recently, Dr. Alan
Leshner and Dr. Frank Vocci, of NIDA, came to NASADAD's annual meeting
to seek State input on how to facilitate the introduction and effective
use of buprenorphine. NASADAD has also consulted with Dr. Westley Clark
of the Center for Substance Abuse Treatment at SAMHSA and with Dr.
Donald Vereen, of ONDCP, on this matter.
Treatment Gap
States strongly agree with Federal Officials that the treatment gap
for persons with alcohol and other drug problems is unacceptable, that
treatment waiting time must be reduced, and that patient treatment
outcomes must be improved. ONDCP notes estimates that only about 50% of
those who need treatment for substance abuse problems receive it.
Priority populations for treatment include youth, pregnant and
parenting women, parents who receive welfare payments to support their
children, parents of children who are in the child welfare system, and
individuals who have HIV/AIDS, Hepatitis B and C, tuberculosis, or
serious mental health problems.
ONDCP estimates that there are 800,000 opiate dependent persons in
this country, of which 600,000 do not have access to treatment. The
availability of cheap heroin in a form pure enough to be smoked or
inhaled is facilitating the entry of a newer, younger cohort of opiate
dependent persons.
A comprehensive treatment approach is needed to treat populations
who have a combination of biological, health, and psychosocial
problems. The untreated population of opiate dependent persons
continues to be a key factor in the spread of HIV, Hepatitis B and C,
and TB. Most have lost their livelihood, their health insurance, and
their support systems. To support their addiction, some have engaged in
criminal activity.
While medications are essential to their treatment, successful
recovery is often tied to counseling services designed to motivate the
entry and continued participation of patients in treatment, to make
difficult lifestyle changes, and to maintain recovery.
Also critical to successful outcomes are the case management
services that help an individual to access health care, find housing,
as well as secure and maintain employment.
Cost of Medication for Opiate Dependent Persons
One issue of great importance to the use of medications for
addiction is what is the cost and who will pay? The cost of a daily
dose of methadone is estimated to be between 28 and 60 cents; while the
cost for the longer acting LAAM is between $2.80 and $3.96 per dose. It
is estimated that a 36-hour dose of buprenorphine will cost between $8
and $10 per day.
Few patients have the resources to pay for their own medications.
Of those working, many do not have health insurance. Of those that have
health insurance, most private plans do not cover medications for
addiction. Changes in Federal and State law related to disability and
welfare reform mean that many patients are no longer eligible for
Medicaid. Finally, substance abuse services and medications are
optional under Medicaid and provide only limited coverage to those
individuals who do qualify.
For the majority of opiate dependent persons, the State will
ultimately be responsible for paying for medications either through the
use of funds from the Substance Abuse Prevention and Treatment (SAPT)
Block Grant, or through State general revenue, or through the Medicaid
funding partially financed by States. Unless additional dollars are
made available, difficult choices will have to be made regarding the
expanded use of medications versus cuts in treatment services.
comments
It is our understanding that the House is considering offering
legislation similar to S.324, the Drug Addiction Treatment Act, with
respect to registration requirements for practitioners who dispense
narcotic drugs in Schedule IV or V for maintenance or detoxification
treatment. The Act would allow qualified physicians, as determined by
the Department of Health and Human Services (DHHS), to prescribe
Schedule IV and V medications in physician's offices without an
additional Drug Enforcement Administration (DEA) registration if
certain conditions are met.
Our primary concern with regard to S.324 is the preemption of the
rights and responsibilities of the States with regard to this new
proposal. Preemption of State's rights is not acceptable given the
significant role that States play in administering and funding the
alcohol and other drug prevention and treatment system. Additionally,
preemption is not logical given that States are the most likely source
of funds to pay for medications such as buprenorphine.
Congress may wish to consider whether or not legislation of this
type is needed given that both the Federal government and States are
already moving forward in planning for the adoption of buprenorphine.
The Food and Drug Administration (FDA) is in the process of completing
its review and approval of buprenorphine and the National Institute on
Drug Abuse (NIDA) has completed important clinical trials and is in the
final stages of its research process.
In anticipation of final FDA approval, the Substance Abuse and
Mental Health Services Administration (SAMHSA) has initiated the
process of developing regulations on buprenorphine.
The regulation of buprenorphine is expected to follow along the
same lines as proposed for methadone/LAAM in the Federal Register of
July 22nd. The new regulations for methadone/LAAM will dramatically
shift the focus from an overly regulated ``process oriented'' system to
one that emphasizes greater administrative flexibility, responsiveness
to changes in the narcotic population, the need for fewer constraints
on clinical judgement, and recognition of the importance of more
intense and focused treatment for the patient at earlier stages. In
addition, revisions will also allow for the collection and analysis of
data, appropriate safeguards for the patient, and an assessment of
treatment success.
These are some questions that should be considered with regard to a
shift from the comprehensive community based treatment system utilized
by States to assist opiate dependent persons to a system in which
individual physicians may prescribe Schedule IV and V drugs from an
office based practice:
Counseling: How will counseling, essential to motivation and
lifestyle changes, be provided to a patient who receives
medication from an individual physician? Who will provide these
services, how often will they be provided, and how will they be
paid for?
Case Management: How will case management services be provided
to help opiate dependent patients find housing, employment, or
to access other services that they may require to achieve and
sustain recovery?
Multiple Addictions: How will individual physicians assist the
large number of patients who are not only dependent on opiates
but also on cocaine and alcohol? States currently contract with
treatment programs that have experience in helping patients to
overcome multiple addictions.
Hard-To-Serve Patients: Will private practice physicians or
managed care health programs be willing and able to accept
hard-to-serve -opiate dependent persons into their practices?
How will outreach and follow up be handled? Alcohol and drug
treatment providers have significant experience with patients
who are low income, often poorly motivated, and sometimes in
denial or uncooperative.
Who Will Pay: Will opiate dependent persons be able to afford
between $2,920 and $3,650 per year to pay for buprenorphine or
utilize their health insurance to cover this medication? Or
will States be expected to assume the financial burden?
Health Services: Will opiate dependent persons also be able to
access other health care services such as treatment for HIV
AIDS or Hepatitis B and C from the same physician who
prescribes buprenorphine? States currently use a combination of
Federal, State, and local funds to assure comprehensive health
care for opiate dependent patients.
Multiple Enrollments: What controls will be in place to ensure
that multiple enrollments do not occur? States currently
utilize a variety of systems to identify patients who may
attempt to scam the system by registering with more than one
program.
Specialized Training: What kind of specialized training will
be required for physicians who dispense buprenorphine from an
office based setting? NASADAD supports the certification
program offered by the American Society for Addiction Medicine
(ASAM).
NASADAD is committed to working with its Federal partners and key
stakeholders to develop answers to these questions and work to close
the treatment gap.
an action plan for new medications
At our 1999 annual meeting, NASADAD and its members began a
discussion with NIDA, SAMHSA, and ONDCP officials about how to best
prepare States, community providers, practitioners, and other key
stakeholders for the introduction of new medications. One idea that
received a great deal of support was to convene a cross section of
experts to develop a framework and action plan for the adoption of new
medications to treat addictions.
Participants of this small expert work group would include
representatives of NASADAD, the American Society for Addiction
Medicine, the American Methadone Treatment Association, other key
stakeholders, and Federal officials from NIDA, NIAAA, SAMHSA, and
ONDCP.
The primary task of this expert work group would be to facilitate
the use of buprenorphine and other new medications across all 50 States
and in a variety of treatment settings. In addition, the work group
would be expected to develop consensus on appropriate policies and
protocols needed as well as to address funding concerns. We look
forward to working with others to make this concept a reality in the
next year.
Thank you for the opportunity to testify before you.
Mr. Bilirakis. Thank you, Mr. Anderson. We certainly do
need your viewpoint, the viewpoint of the States. Obviously we
appreciate you being here.
Dr. Kosten.
STATEMENT OF THOMAS KOSTEN
Mr. Kosten. Thank you very much. I am president of the
American Academy of Addiction Psychiatry, which represents over
1,000 psychiatrists who treat addictions, and also represent
the American Psychiatric Association, which represents 42,000
psychiatrists, many of whom do treat addictions. I am also a
provider myself, being chief of psychiatry for VA Connecticut,
with 35,000 veterans in primary health care and another 7,500
veterans with speciality substance abuse care.
In the interest of time, certainly I will try to be quite
brief and not go through the statement that I have here. I
would like to say, though, my organizations are somewhat
troubled by the opposition voiced by some Members of Congress
to effective medication therapy for addictive disorders, and we
hope that is something that these type of hearings can start to
address with buprenorphine, LAAM, and, of course, methadone.
These are very effective treatments, and I would like to
emphasize that one of the people who was going to come with me
today, Jerri Bryant, is somebody who helped set up the
methadone maintenance programs in New Haven, while she was
indeed on methadone maintenance. She has since left methadone
maintenance and is one of the leaders in AIDS prevention and
treatment initiatives in southern Connecticut, and she is just
one of the hundreds of success stories that we have. So I want
to emphasize that this is the type of treatment that can be
highly successful and has many success stories.
There are less than 15 percent of opiate addicts who can
get effective treatment in the VA. The number is only about 20
percent when you don't have the NIMBY effect; that is, you can
locate these programs on campuses, veterans hospitals. But the
issue is there are constraints, there is a denial here to
target withdrawal of resources from patients with substance
abuse. It is quite exclusive in the VA system, and it is
occurring throughout the country.
I would like to say that there is bureaucratic regulation
that is getting in the way of the central effective life-saving
treatments such as buprenorphine. Office-based buprenorphine
treatment has been highly successful in Connecticut. We are one
of the only States that have, in fact, tested this out. We
compared office-based treatment to buprenorphine given in the
methadone setting. When you give it in office-based setting,
they stayed in treatment longer, they have better patient
satisfaction, and they had less illicit heroin use than the
ones who, in fact, got in a methadone setting. Everything
suggests this would be a very effective way to deliver this
medication, and I think at this point it is really bureaucratic
regulations that are standing in the way.
I would like to also emphasize that in the United States
there are physicians who are quite ready to make this reality
from both my organization and the American Society of Addiction
Medicine, as well as the American Psychiatric Association.
Another issue I would like to briefly just state, with
buprenorphine--I apologize, I tried to get copies of this
figure to everyone, I am not sure they got it--if you look at
this, what this simply illustrates is severity of withdrawal
symptoms versus amount of time or amount of dollars that it
costs to provide detoxification. If you do it the standard way
that is shown in green, what that can cost in the usual
settings are thousands of dollars, typically 5- to $6,000. The
red, which is shown at the end here, is using buprenorphine to
facilitate detoxification. You can, in fact, get it down it a
procedure that costs about $500. There is cost-effectiveness
that is here and quite explicit and quite clear.
I think other issues that I would like to emphasize is that
we have had major pharmacotherapy challenges with cocaine. I
have given you a little toy up here. It is, in fact, a human
brain. This is what it looks like. The red things on it are
blood vessels. Those blood vessels on the human brain are, in
fact, blocked by cocaine. What happens is there are platelets,
which are blood cells that stick together, and it is
vasoconstriction in these blood vessels in the brain. You get
that combination, together it gives you a stroke. When you are
60 years old and you get a stroke, you get paralysis and other
kinds of symptoms. When you are 25 years old and you get these
mild strokes, all that happens is you can't think and can't
concentrate anymore, which means you don't pay attention to any
of the reasons to stop using cocaine.
This is a major problem that we have, and research from
NIDA has, in fact, discovered these problems, been able to
identify them, and we are now beginning to develop effective
treatments. One of the most effective ones I would like to just
briefly mention is a vaccine that we have developed. We have
done the initial studies in animals. In the animals they stop
self-administering cocaine when given this vaccine. The first
human study was just completed 2 months ago. It was given to 34
cocaine abusers. It was perfectly safe for them. They had
virtually no side effects from it. They also produced
substantial quantities of antibodies. A large-scale study of
this is planned for the fall. I think this is an extremely
effective and promising intervention that will lead to
vaccination given over a period of about a month, leading to
treatment that potentially would be effective for a year or so
after that. There is a couple of articles that I have enclosed
from Discover Magazine and the London Sunday Times. This has
gotten worldwide recognition as an extremely important
innovation.
There has been substantial success on many fronts in our
battle with this disease. The pharmaceutical companies are
beginning to join us. As a small example, both buprenorphine
and the cocaine vaccine are being developed by industry
collaborations. I hope that this congressional sentiment for
changes in needless bureaucratic regulations can further this
collaboration and have it spread to the pharmaceutical giants
in this country. We must get them to join us in this successful
and historic battle to conquer these diseases.
Thank you very much for this opportunity to appear before
you. I would be happy to answer any questions you may have,
particularly questions about the success we are having in
office-based opioid treatment in Connecticut. Thank you.
[The prepared statement of Thomas Kosten follows:]
Prepared Statement of Thomas Kosten, President, American Academy of
Addiction Psychiatry
Mr. Chairman, I am Dr. Thomas Kosten, President of the American
Academy of Addiction Psychiatry representing 1000 psychiatrists
treating substance-abusing patients in office based and other community
settings. I am also the former Vice-chairman of the Council on
Addictions of the American Psychiatric Association representing 42,000
psychiatrists, most of whom treat addicted patients in some portion of
their practice. I am also a provider myself as Chief of VA Psychiatry
for the state of Connecticut caring for over 35,000 veterans in primary
medical care and over 7500 veterans in specialty substance abuse
programs. Formerly, I was medical director of the APT Foundation,
treating over 2000 heroin and cocaine abusers in New Haven Connecticut.
I thank you for the opportunity to present my personal experiences
in addiction treatment and my organization's recommendations for
improving the treatment of hard core drug dependent patients. I ask
that my written comments, the two magazine articles, and the graphics
that I have today be considered for inclusion in the record. I also ask
that you open the box in front of you and take out the human brain
inside it during these introductory remarks.
Before beginning my comments I would like to thank the committee
members and your colleagues in the House for your commitment to
providing the highest quality medical care to our nation's substance
abusers. I particularly commend your commitment to our veterans, who
have in the past been threatened with denial of medical care because
their disease was considered ``willful misconduct.'' Addiction is truly
a brain disease, and our science supports its implication of effective
pharmacotherapy to re-normalize drug induced brain dysfunction. To
illustrate this brain dysfunction I will later ask you to refer to the
brain that I have given you.
Having applauded your commitment, I must also state that the AAAP
and APA are troubled by the opposition voiced by some members to
Congress to effective medication therapies for addictive disorders.
Under Dr. Schuster and now Dr. Leshner's leadership buprenorphine and
LAAM, a long acting form of methadone, have already been shown to be
most effective community treatments for heroin, and prejudice and poor
judgement are undermining their widespread use. Rather than
constriction, we at AAAP fully support the extension of these effective
therapies more broadly into the community of office based medical
practitioners. Methadone has been life-saving for many patients who
have become community leaders in Connecticut. For example, Jerri Bryant
founded the New Haven methadone programs with Dr. Herbert Kleber, while
herself being on methadone maintenance in the early 1970s. She then
successfully graduated from methadone maintenance and became a key
community leader for AIDS prevention and treatment in all of southern
Connecticut. While she is one example of a success for methadone, there
are hundreds more in New Haven alone.
Less than 15% of all opioid dependent patients can get effective
pharmacotherapy. Even among veterans, where ``community'' opposition to
treatment programs is minimal, only about 20% of them are getting the
help they need. This denial of care is due to targeted withdrawal of
resources from substance abuse treatment by the VA and constraints on
office and community based care by federal regulations. While about 10
years ago I testified before the Congress and opposed the simple
dispensing of methadone without psychosocial support, office based
opioid treatment, like quality methadone clinics, includes weekly
counseling. This counseling offers the patient the opportunity to
change lifestyles and is critical to the success of any program of
treatment.
The current unnecessary bureaucratic regulation of essential,
effective and life-saving treatments comes at a time of unprecedented
success in developing new pharmacotherapies for the addictive
disorders. Office based buprenorphine treatment has been highly
successful in our Connecticut medical practice. We recently compared
buprenorphine offered in an office-based primary care setting to a
standard methadone treatment program setting. Both programs included
counseling. The patients getting the office based care stayed in
treatment longer, had better patient satisfaction and had less illicit
heroin use than those treated in the methadone type setting with all
its constraints and controls. On every outcome measure including cost
efficacy, office based practice was superior. Only bureaucratic
regulations stand in the way of more broadly implementing this
successful experiment in Connecticut, and throughout the United States
our 1000 members in AAAP are ready to make this promise a reality.
Other successes for pharmacotherapy include new opioid
detoxification programs using buprenorphine, clonidine and naltrexone,
which were pioneered by Dr. Kleber and amplified by some of my work
with him. As shown in the handout figure, the severity of opioid
withdrawal symptoms (on the vertical axis) are made both less severe
and can be reduced from two weeks to 8 hours using the most modern
techniques. These techniques save not only suffering, but are also
highly cost effective, saving thousands of dollars per patient compared
to our past techniques using tapering doses of other medications. These
techniques were developed under the leadership of Dr. Schuster, while
he was Director of the National Institute on Drug Abuse, and have been
continued under the outstanding leadership of Dr. Leshner and Dr.
Vocci, the Director of Medications Development at NIDA. Under their
leadership NIDA has developed other effective medications such as
naltrexone for opioids and is establishing industry collaborations for
this potential market of over $3 billion.
The major pharmacotherapy challenge remains cocaine and
amphetamines. While we do not yet have an effective pharmacotherapy, we
now understand many brain derangements caused by these drugs. This
understanding has led directly to innovative new approaches for re-
normalizing this deranged brain chemistry. Using brain imaging we have
found abnormalities in the living brain of these tragically effected
fellow citizens, and these abnormalities can be directly targeted by
medications. For example, the brain you have in your hands has red
lines on it representing the blood vessels supplying it with life. If
these vessels are blocked for even a few minutes, brain cells die and
thinking, feeling, moving and life itself can cease. Cocaine blocks
these blood vessels by constricting them and filling them with abnormal
clotting cells called platelets. A large blockage like this leads to
strokes in some cocaine abusers, and in most abusers the blockages are
smaller, but occur in multiple places in the brain. These multiple
blockages leaves the cocaine abuser's brain shrunken, discolored and
often poorly functioning, like this model I have in my other hand.
While these 25-year-old cocaine abusers have problems in memory and
concentration, in contrast to the 60-year-old with such a stroke, they
rarely have paralysis or other obvious major symptoms. Because of this
lack of obvious dysfunction and their inability to think clearly, these
young adults do not see the obvious dangers to themselves. Because of
research funded by NIDA, however, this picture of brain damaged young
adults may be changing. Using medications to treat stoke victims, we
have found much better therapeutic responses than typically can be
expected with strokes. Brain blood flow has shown marked improvement
after only a month taking these medications, which produce only quite
modest improvement in older stroke victims. Cocaine abusers treated
with these medications also improve their thinking and concentration.
We indeed have great hope for this approach to re-normalization and
rehabilitation.
Another example of a success is the development of a vaccine to
reduce the effects of cocaine and its abuse. In animals this vaccine
causes them to stop self-administering cocaine, a sign that this may
also work in human cocaine abusers. We have just completed the first
human study of this vaccine in 34 cocaine abusers, and it has been
highly successful in producing antibodies that last for months and in
having no significant side effects. Later this year we hope to begin
larger scale studies of this vaccine with continued NIDA support. I
have included two articles from Discover magazine and the London Sunday
Times providing more details about this vaccine.
Thus, we have had substantial success on many fronts in our battle
with these diseases, and the pharmaceutical companies are beginning to
join us. As a small example, both buprenorphine and the cocaine vaccine
are being developed by industry collaborations. I hope that
Congressional sentiment and changes in needless bureaucratic
regulations can further encourage this collaboration and have it spread
to the pharmaceutical giants in our country. We must get them to join
in this very successful and historic battle to conquer these diseases.
Thank you again for this opportunity to appear before you. I would
be happy to answer questions you may have, particularly questions about
the success that we are having with office based opioid treatment in
Connecticut. I also hope that you will find a way to convey to the
American public and its industry leaders the personal message that you
hear from my Connecticut treatment staff.
From the APT program I am privileged to bring three of our staff
members: Jeri Bryant, John Proto, and Donald Tagg. Jeri Bryant is a
former methadone patient herself and a founder with Dr. Herbert Kleber
of the APT methadone programs. John Proto is a former cocaine abuser
and current counselor in the APT programs. Donald Tagg is a teacher in
the APT residential program for substance abusing adolescents. Each of
them has a personal story to tell about substance abuse in their lives
and the promise of treatments such as methadone or buprenorphine. I
hope that we can get these stories out to our fellow citizens.
Mr. Bilirakis. Thank you, Doctor.
Ms. McColl.
STATEMENT OF JENNY COLLIER-McCOLL
Ms. Collier-McColl. Thank you, Mr. Chairman. Good morning,
Congressman Brown and members of the subcommittee. My name is
Jenny Collier-McColl, and I am the Director of National Policy
for the Legal Action Center, which is a nonprofit law and
policy firm, and we represent individuals who are struggling
with or in recovery from alcohol and drug problems and AIDS, as
well as their treatment providers across the Nation. Thank you
for the opportunity today to testify on the Drug Addiction
Treatment Act of 1999 and access to alcohol and drug treatment
services.
Expanding access to these services is an essential step to
meeting Congress' goals of reducing drug use, successfully
reforming the welfare system, and decreasing crime. Last year
drug use among youth remained at the highest level in 10 years.
Access to alcohol and drug treatment services does not meet the
current need. Only 50 percent of individuals who need treatment
receive it. Waiting lists for alcohol and drug treatment
services are 6 months long in some regions. For adolescents the
problem is much worse. Only 20 percent of adolescents with
severe alcohol and drug programs receive treatment.
More treatment and prevention services are needed now,
especially since the need for them is growing daily. While
developing appropriate new research-based addictions
medications and protocols such as buprenorphine is an essential
part of improving treatment effectiveness, these activities
alone do not significantly expand access to alcohol and drug
treatment. Inadequate public and private funding for alcohol
and drug treatment services is the most significant barrier to
recovery. Congress must address this problem so that we can
develop a comprehensive system of care for this Nation.
Lack of funding for treatment also reduces incentives for
treatment expansion by both providers and medications
development by pharmaceutical companies. Even if we succeed in
developing the best, most effective care and medication for
individuals with alcohol and drug problems, treatment
providers, both public and private, as well as pharmaceutical
companies will be unable to invest without sufficient resources
to support these innovations. Publicly funded community-based
programs will be unable to expand access to new and effective
treatments without additional funding because of the intense
competition for scarce resources that presently exists.
Supporting new medications and protocols will be unaffordable
for most pharmaceutical companies and for-profit providers
unless additional resources, such as increased insurance
coverage for treatment through parity, is achieved.
Private treatment and medication can be very expensive, as
you heard just a few minutes ago, and few individuals can
afford to pay for care on their own. Therefore, in addition to
supporting development and access to new treatment medications
and protocols, as Congressman Bliley's Drug Addiction Treatment
Act attempts to do, Congress must increase its financial
commitment to alcohol and drug treatment in order to
significantly increase access to these services.
Increased investment and treatment can be achieved in
several ways. One way would be to increase funding for the
substance abuse prevention and treatment block grant to $1.885
billion, for an overall increase of $300 million over fiscal
year 1999 funding; also to allocate $100 million each for the
Center for Substance Abuse Treatment and Prevention's targeted
capacity expansion programs that provide targeted services
tailored to address the specific and emerging drug epidemics
such as heroin in underserved populations by enhancing Medicaid
coverage of alcohol and drug treatment services, and this can
be done in two ways. The first would be to make alcohol and
drug treatment a required service under the Medicaid program.
Currently only 25 States choose to cover alcohol and drug
treatment services, and even in this State not all alcohol and
drug treatment services are actually covered.
Another way to enhance Medicaid would be to lift the
institution for mental diseases exclusion, which reduces access
to residential treatment services. Then the final way would be
to institute substance abuse treatment parity for private
insurance to increase the amount of private funding that is
invested into these services as they are invested into other
treatment services for other chronic relapsing diseases.
I also urge the committee to take up SAMHSA reauthorization
as soon as possible. This legislation plays a critical role in
designating funding and programs that support alcohol and drug
treatment and prevention services. Reauthorizing these programs
provides necessary oversight and sends the important message
that alcohol and drug treatment and prevention services are
priority public health issues. Prevention, treatment and
continued research are our best hope for reducing alcohol and
drug use and their associated crime, health, welfare, and
social costs. Continued investment in these areas will save
lives and resources nationwide.
Thank you very much for inviting me to testify today. I
would be glad to answer any questions.
[The prepared statement of Jenny Collier-McColl follows:]
Prepared Statement of Jenny Collier-McColl, Director of National
Policy, Legal Action Center
introduction
Good morning, Mr. Chairman, Congressman Brown, and members of the
Subcommittee. My name is Jenny Collier-McColl and I am the Director of
National Policy for the Legal Action Center, a non-profit law and
policy firm that represents individuals in recovery from and struggling
with alcohol and drug problems and AIDS and their treatment providers.
Thank you for this opportunity to testify on ``The Drug Addiction
Treatment Act of 1999,'' and access to alcohol and drug treatment
services.
Expanding alcohol and drug treatment and prevention services is an
essential step to meeting the Congress' goals of reducing youth drug
use, successfully reforming the welfare system, and decreasing crime.
Last year, drug use among youth remained at the highest level in ten
years. Access to alcohol and drug treatment does not meet the current
need for services--only 50% of the individuals who need treatment
receive it. Waiting lists for alcohol and drug treatment are six months
long in some regions. For adolescents the problem is much worse--only
20% of adolescents with severe alcohol and drug problems receive
treatment. More treatment and prevention services are needed now,
especially since the need for them is growing daily.
While developing appropriate new, research-based addictions
medications and protocols, such as Buprenorphine, is an essential part
of improving treatment effectiveness, these activities alone do not
significantly expand access to alcohol and drug treatment. Inadequate
private and public funding for alcohol and drug treatment services is
the most significant barrier to treatment and prevention services.
Congress must address this problem so that we can develop a
comprehensive system of care for this nation.
Lack of funding for treatment also reduces incentives for treatment
expansion by providers and medications development by pharmaceutical
companies. Even if we succeed in developing the best, most effective
care and medication for individuals with alcohol and drug problems,
treatment providers, both public and private, as well as pharmaceutical
companies will be unable to invest in them without sufficient funding
to support these innovations. Therefore, in addition to supporting
development and access to new treatment medications and protocols, as
Congressman Bliley's ``Drug Addiction Treatment Act'' attempts to do,
Congress must increase its financial commitment to alcohol and drug
treatment in order to significantly increase access to these services.
A final barrier to treatment is stigma around the diseases of
alcoholism and drug dependence. Stigma shows its ugly face in several
ways, from legislatures trying to defund certain types of treatment to
communities resisting the placement of alcohol and drug treatment
facilities or sober housing in their neighborhoods. Increased financial
investment coupled with action to destigmatize these diseases are
solutions to overcoming the barriers to treatment.
alcohol and drug treatment and prevention are highly effective
Providing alcohol and drug treatment and prevention services
reduces drug use as well as the associated health, welfare, social,
child welfare and criminal justice costs. The 1996 National Treatment
Improvement Evaluation Study (NTIES), which evaluated 78 treatment
programs funded by the Center for Substance Abuse Treatment (CSAT),
found sustained reductions in drug use, welfare dependence, and crime
and increased employment among 5,700 individuals one year after they
completed treatment.
Specifically, NTIES found that:
Crack use decreased by 50.7% and heroin use by 46.5%.
Employment increased by 18.7% and welfare dependence decreased
by 10.7%.
Homelessness decreased by over 40%.
Drug sales decreased by 78.2%, physical beatings by 77.6%, and
shoplifting by 81.6%.
Research-based prevention programs are extremely effective in
preventing alcohol and drug use among youth. The National Structured
Evaluation, an evaluation of services provided in prevention programs
across the nation between 1980 and 1993, found that a variety of
approaches including counseling, peer leadership, stress management,
skills development and other techniques effectively prevent alcohol and
drug use.
pressures on the public treatment and prevention system
Treatment and prevention systems have faced increased pressure from
entitlement reforms, specifically welfare and SSI program reforms, that
decrease system capacity while increasing the need for public treatment
and prevention services.
Welfare reform has reduced treatment availability by making
individuals convicted of drug felonies after August 22, 1996 ineligible
for cash assistance or food stamps in many states. Residential
treatment programs, particularly programs serving low-income women and
children, have relied on the these funds to help support room and board
costs of care. Without these funds, treatment availability will
decrease.
Welfare reform also requires states to move individuals from
welfare to work within a given time period, or a state's federal
welfare funding will be decreased. Several national studies have
concluded that 16-20% of welfare recipients have alcohol and drug
problems. This could translate into an additional 400,000--1,000,000
adult welfare recipients needing treatment to move into recovery, off
welfare, and into jobs.
This increase in the need for women's treatment, particularly women
with children, comes at a time when this system faces great financial
pressure. Funding from the Center for Substance Abuse Treatment, which
has supported residential programs for women with children and programs
for pregnant and postpartum women and infants, has ended or will be
ending this fiscal year for the majority of grantees. Without
additional funding, many programs for women with children will have to
reduce or discontinue the services they offer, thus widening the
treatment gap for these families.
Loss of Supplemental Security Income (SSI) support for individuals
with alcohol and drug problems also has increased the need for public
treatment services. On January 1, 1997, an estimated 200,000
individuals with alcohol and drug disabilities lost their SSI and
Medicaid coverage. Less than 60,000 of these individuals have
requalified for SSI and Medicaid under another disability. Methadone
maintenance, residential, and outpatient programs have relied on
Medicaid to provide treatment. These programs now face budget gaps
which reduce treatment availability.
Successful criminal justice programs involving (and often
mandating) treatment, including drug courts, have proliferated and are
steadily increasing the demand for treatment. The success of these
programs hinges on adequate and immediate treatment availability.
increased public funding will expand access to treatment
The primary source of federal funding for alcohol and drug
treatment is sent directly to states through the Substance Abuse
Prevention and Treatment (SAPT) Block Grant. The Substance Abuse Block
Grant accounts for over 40% of public funding for these services
nationwide.
To help meet the pressing need for alcohol and drug treatment and
prevention services, we urge Congress to increase funding for the SAPT
Block Grant to $1.885 billion for an overall increase of $300 million
over FY 99 funding.
In addition to adequate funding for the Substance Abuse Block
Grant, increased funding should be invested in Targeted Capacity
Expansion programs under the Centers for Substance Abuse Treatment and
Prevention to help meet the evolving needs of communities. These
programs are targeted, gap filling services tailored to address
specific and emerging drug epidemics and/or underserved populations.
increasing medicaid coverage will expand access to alcohol and drug
treatment
Many low-income individuals, including all women on welfare and
those in families involved in the child welfare system, are eligible
for Medicaid, the main source of health care funding for low-income
individuals without private health insurance. However, Medicaid
coverage for alcohol and drug treatment services for these individuals
and families is unnecessarily limited.
The national goal of reducing alcohol and drug use and their
devastating consequences on individuals, families, and society requires
better Medicaid coverage for treatment. Medicaid coverage for alcohol
and drug treatment could be enhanced by:
Making alcohol and drug treatment required services under the
Medicaid program.
Medicaid finances some drug and alcohol treatment, subject to state
limits on amount, duration, and scope, but alcohol and drug treatment
is not a required service under the program. States providing treatment
to Medicaid clients can receive reimbursement if the treatment is
provided under a Medicaid service category that qualifies for Federal
matching funds.
For example, if alcohol or drug detoxification is provided as part
of general inpatient hospital treatment, it is reimbursable under
Medicaid in most states. Other aspects of treatment, such as
prescription of methadone, may also be covered. At State option, clinic
treatment services can also be covered.
The advantage of this policy change is that it would help establish
a more stable source of funding for treatment that is not discretionary
and subject to the annual appropriations process. Such stability will
increase access to treatment for low-income individuals and families
who presently rely on limited Substance Abuse Prevention and Treatment
Block Grant and scarce discretionary funds to support treatment
services.
Lifting the ``IMD exclusion.''
One of the most serious roadblocks preventing low-income
individuals from obtaining residential alcohol and drug treatment has
been the ``Institution for Mental Diseases (IMD) exclusion.'' The IMD
exclusion is a statutory provision that prohibits Medicaid from paying
for institutional treatment for individuals between 22 and 64 who are
diagnosed with mental diseases and receiving treatment in programs with
more than 16 treatment beds. In addition, individuals who enter IMDs
lose their Medicaid eligibility for all Medicaid reimbursable services,
including prenatal and HIV care.
While Congress never explicitly defined mental diseases to include
alcoholism and drug dependence, the Health Care Financing
Administration (HCFA) has interpreted mental diseases to include
addiction. Numerous organizations and advocates have spent years trying
to change the IMD exclusion as it applies to alcohol and drug
treatment, both through the courts and the legislative process.
The simplest way to change the IMD exclusion would be to amend the
regulations by removing ``substance abuse'' from the definition of
``mental diseases.''
However, legislative options are also available. During the 105th
Congress, Senator Daschle introduced legislation, S. 147,1
which would lift the IMD exclusion for pregnant and postpartum
women.2 The Congressional Budget Office scored a previous
version of this legislation as costing only $145 million over five
years.3
---------------------------------------------------------------------------
\1\ The ``Medicaid Substance Abuse Treatment Act of 1997'' is also
co-sponsored by Senators Chafee, Kennedy, Johnson, and Reid.
\2\ The bill would prohibit reimbursement for facilities with more
than 60 beds (unless waived by the state alcohol and drug agency) or
licensed as a hospital. It would also set a ceiling on the number of
beds covered at 1,080 in 1998 up to 6,000 in 2002. After 2002, the
Secretary would determine the number of beds covered.
\3\ The provision had been included in the Senate version of the
1993 budget reconciliation act but was dropped in conference committee.
---------------------------------------------------------------------------
substance abuse parity will expand access to treatment
Government has overlooked an important partner in the solution to
the alcohol and drug problems--the private sector. More than 70 % of
drug users in 1996 were employed, including 6.2 million full-time
workers and 1.9 million part-time workers. Unfortunately, some workers
have unnecessarily limited health insurance benefits for alcohol and
drug treatment, and others have none at all.
According to a 1993 study, most private health insurance plans that
cover alcohol and drug treatment set annual and lifetime financial and
visit limits on the benefits. These limits, combined with the fact that
drug abuse is a chronic, recurrent condition, mean that covered
individuals quickly exhaust their benefits.
When privately insured individuals exhaust their benefits, they
turn to the public sector for treatment, which increases costs to
federal, state, and local governments. A 1994 study estimated that 20 %
of public reimbursements are for clients who have private health
insurance. Privately insured individuals seeking treatment in the
public sector crowd out individuals traditionally served by the public
sector and increase waiting lists for publicly-funded treatment.
Better and more comprehensive private health insurance coverage is
affordable. A 1997 actuarial study estimated that full parity would
increase insurance premiums by just one-half (.5) of 1 %, only pennies
per day per person covered.4 A 1998 study by Mathematica
Policy Research estimated that full parity for alcohol and drug
treatment services would cost even less--increasing composite health
insurance premiums by one-fifth (.2) of 1%.5
---------------------------------------------------------------------------
\4\ Milliman & Robertson, ``Premium Estimates for Substance Abuse
Parity Provisions for Commercial Health Insurance Products,'' September
2, 1997.
\5\ Substance Abuse and Mental Health Services Administration,
``The Costs and Effects of Parity for Mental Health and Substance Abuse
Insurance Benefits,'' prepared by Mathematica Policy Research)
---------------------------------------------------------------------------
Providing drug and alcohol treatment services on par with services
for other physical illnesses will decrease health care and other costs
for employers. Health care costs will decrease because treated
employees and members of their families use fewer health services.
Untreated alcoholics incur general health care costs that are at least
100 % higher than non-alcoholics. Sickness claims, hospitalizations,
and days lost to illness drop by 50% after treatment.6
Health care utilization by the family drops 50%.7 Other
costs incurred by employers from absenteeism, disability days, and
disciplinary actions all decrease by more than 50% after
treatment.8
---------------------------------------------------------------------------
\6\ President's Commission on Model State Drug Laws,
``Socioeconomic Evaluations of Addictions Treatment,'' 1993.
\7\ Ibid.
\8\ bid.
---------------------------------------------------------------------------
stigma produces an additional barrier to treatment
Alcoholism and drug dependence are treatable diseases that should
be dealt with by the public health system. However, many individuals
view these problems as moral failings as opposed to medical conditions.
This mentality perpetuates the stigma that closets these diseases and
prevents investment in and development of a comprehensive treatment
system. Educating individuals, communities and policy makers about the
treatable nature of addiction and the potential for real recovery will
reduce stigma and its negative consequences. Congress plays an
important role in this educational process, and I thank the members of
this Subcommittee for holding this hearing about alcoholism and drug
dependence and the success of treatment.
conclusion
Prevention, treatment and continued research are our best hope for
reducing alcohol and drug use and their associated crime, health,
welfare and social costs. Continued investment in these areas will save
lives and resources nationwide. Thank you for inviting me to speak on
this important issue today. I will be glad to answer any questions.
Mr. Bilirakis. Thank you, Ms. Collier-McColl.
Perfect timing. Dr. Alexander shared with us the story of
the 12-year-old and the mother wanting her other children to
come in to see him fighting for his life, for a reason, of
course. In his written testimony he also shared with us another
story, and I will just go ahead and read it here.
``One patient in particular stands out. Jason was an 18-
year-old who came in as an overdose of a mixture of heroin and
cocaine. He was not breathing when his father discovered him.
By the time he arrived at the hospital, the paramedics had
gotten his heart going, and he was barely breathing after
getting the drug Narcan en route to the emergency department.
We admitted him to the ICU in a coma.
``Two days later Jason woke up. Shortly afterwards he began
to seize. His temperature was 108 degrees. He had developed
pneumonia in both lungs from vomiting while unconscious.
Between the coma and the seizure, Jason suffered severe brain
damage.
``On October 2, 1998, Jason turned 20 years old. He lives
in a nursing home. He can't talk. He has a hole in his throat
where he is hooked up to a ventilator at night in case he
forgets to breathe. He has a hole in his stomach for a feeding
tube because he can't eat. He wears diapers because he can't
control his bowel or bladder. He is confined to a wheelchair
because his arms and legs are wasted and contracted like a
person with cerebral palsy. He may live to be 70 years old. He
will be like this every day that he lives.''
This really grabs me, and maybe this is commonplace to most
of you because you live with these problems every day. But 2
days ago we had a hearing. I think it was in this room, and the
hearing was on toilet flushing, and we had all sorts of media
here. I didn't chair that hearing. Today we have a hearing
which is--I am not trying to belittle that, but next to this I
think it is easy enough to belittle, and there is no media.
The communication, getting the word out that the mother had
had that particular purpose for her other children to see what
drugs had done to their brother is important. Why Dr.
Alexander, why Dr. Kosten, why do young people know that this
sort of thing might happen to them and just ignore it, because
they think they are immortal or do they think it is just not
going to happen to them? We talk Ms. McColl, and, we are
holding this hearing, and we have already addressed SAMHSA, and
we will reauthorize it, and it takes two to tango, and the
SAMHSA agency has to be a little more helpful in that regard,
et cetera, et cetera. And, you know, we can do something with
the buprenorphine treatment and, but why, why do we have these
problems the way we do? Can we talk about that? I mean, Dr.
Kosten, maybe being a psychiatrist or psychologist----
Mr. Kosten. Psychiatrist.
I will be happy to start at least. I think the issue around
why adolescents think they are invulnerable and why it is going
to happen to their friends and not to them is the story of
adolescents; that is just the way they are. I think the broader
issue around this of why doesn't it get attention is who votes,
to be blunt. Just look at the way the health care system is
treating children right now, or not treating children, to be
more exact. There are major problems with that. And we are
talking about children. We are talking about people who develop
this disease before they are 18 years old and frequently die
from this disease before they are 18 years old. I think that is
a sad commentary on where things are.
But I think one of the things that is very exciting to me
is that the Congress appears to have recognized that on several
levels in terms of research now in children is mandated in
terms of telling the pharmaceutical companies that they have to
study ways to make children better in helping physicians do
this.
And I think the issue of health care parity for substance
abuse is very important. There is, in fact, another issue
there. What about health care parity for children? How is that
insured? How does that happen?
So I think that there is a lot of worrying about what
happens in the health care. I have from quarter to quarter, as
opposed to what is going to happen 5 years down the line, what
is going to happen when have you these complications. What are
you going to do with these children who are now sitting in
nursing homes for the rest of their life until they finally die
of aspiration pneumonia?
Mr. Bilirakis. I guess what I am saying is where are we
failing so this child will not even reach the point of being in
this nursing home to age 70?
Ms. Collier-McColl. I think that is an excellent question.
I think there are a couple of different reasons. One of the
most important reasons is that children are not learning about
the collateral consequences of drug abuse and alcohol abuse.
Prevention is not widespread enough. There are not enough funds
for prevention services, and not every schoolchild in this
Nation has access to those services.
I was a child of the Baltimore school system. I never had 1
minute of drug prevention. My friends now have children in that
system. They still do not get complete access to drug
prevention information.
In addition to that, there also is a lack of early
intervention services. A lot of school-based programs have
services where they can do some initial counseling with a child
when they are identified as having some risk or possibly
starting to use and then refer that child to further treatment
if necessary. Those services aren't available in every school
in this Nation or in every neighborhood or through every
community-based child center. So that is something that we
really have to deal with. That is an access issue to
prevention.
I think this is an excellent question because these
problems go hand in hand. That is something the Congress has
the power to do something about.
Mr. Bilirakis. Dr. Alexander, very briefly I would want
you, of course, to respond.
Mr. Alexander. I just want to echo what Ms. McColl is
saying. Education is the biggest area where we lack with young
people. I travel all over the country talking to school-age
children and to their parents. I find not only do the kids not
know about this stuff, the parents don't either. What they get
through the media sometimes is misleading. What the children
learn about on the street is definitely misleading. These
children then make choices based on wrong information.
Unfortunately they don't understand like we do that it is a
disease process. The first time may be a choice, but once that
choice is made, it may disclose an underlying addiction
problem. These kids don't know how to deal with it.
Mr. Bilirakis. If this story were really out there, I mean,
you know, ``just say no to drugs''----
Mr. Alexander. That never worked. I appreciate the effort.
Mr. Bilirakis. But this would work.
Mr. Alexander. I don't use scare tactics, but I try to tell
the kids the realities of what this means to them. I have kids
faint. I have had kids get up and puke. I had a documentary
crew, the producer fainted dead away. I had to stop and work on
her. When you get something that reaches a gut-wrenching
response, then you know it is going to register into these
kids' brains.
These type of stories about the friends, I pick the stories
about kids who died in their school so they know these people
personally, and that makes an impact to a point. They still
have these other psychosocial factors that fall into place.
They have parents who use at home. They have grown up watching
their parents drink and smoke and do drugs. You have got to
overcome a lot of these things.
Mr. Bilirakis. Mr. Brown.
Mr. Brown. Mr. Rivers wants to say something.
Mr. Rivers. I want to say I am a diabetic. I take insulin
twice a day to control my diabetes. And then when it comes to
addiction and stuff, there was a time I didn't realize that it
was a disease, just like my diabetes when I take my medication
and stuff, it works both ways.
Mr. Bilirakis. Well, now, were you addicted in Korea when
you were in the military, or were you addicted after you----
Mr. Rivers. After I came back.
Mr. Bilirakis. You were well in your twenties at that time.
Mr. Rivers. Right.
Mr. Bilirakis. You didn't know that the drugs would be
conceivably pretty bad for you.
Mr. Rivers. No, I didn't.
Mr. Bilirakis. You did not know that.
Mr. Brown.
Mr. Brown. Thank you, Mr. Chairman.
Ms. McColl, thank you for your eloquent testimony,
especially about Congress' and the States' failure to fully
fund treatment programs. Your mention of 50 percent of people
don't get treatment, and I guess that number is significantly
higher among the poor and young and among heroin addicts over
alcohol or drug abuse. Six-month waiting lists you mentioned.
Tell us what alcohol and drug treatment services should be
covered under the Medicaid program. How should that be
expanded? What should we and the States do?
Ms. Collier-McColl. Well, I think the first thing that
needs to be done is that you could actually require that
alcohol and drug treatment services actually be a required
service under the Medicaid program. You have other required
services, other kinds of doctor visits, and that would be
treated as a matter of course if you have Medicaid coverage.
That is not necessarily true if you are a recipient of Medicaid
and have an alcohol and drug problem and need treatment. So
that would be the first way to repair that, actually make it a
part of the comprehensive set of services that are covered by
Medicaid.
Then I think the second question you asked is what types of
services would you want covered if you had that benefit in
place. And those services would be the complete spectrum of
treatment services from initial detoxification through either
residential outpatient, or intensive day treatment, through any
after-care services that are required. You want to have that
complete spectrum, because when you completely treat people,
and they are able to go into recovery, they become well, they
start to work, they start to make money, they start to pay
taxes, they raise their children responsibly. And their health
care costs drop by at least 50 percent or higher. And so you
are saving money, and you are generating income when people go
into recovery.
So certainly providing that opportunity for low-income
individuals who are covered by Medicaid, and many of those
individuals are women with children on welfare, that would make
a lot of sense because it would help the overall health of that
family and that individual as well as generate income savings
later through helping people recover and go back to work.
Mr. Brown. Where does society generally do better on drug
and drug treatment--if 50 percent of people get treatment, but
it is significantly lower among the young, and significantly
lower among heroin users, and significantly lower among the
poor, where does society do generally pretty well, or is that
too strong a statement with drug and alcohol abuse?
Ms. Collier-McColl. Well, clearly men are getting more
treatment than women because the original treatment system was
designed for men actually. So if you are a man, you are more
likely to get treatment. There are more programs for you.
Because if you are a woman, frequently you have kids, and there
are not many programs that can serve you without you
relinquishing custody of your children. So you are doing well
depending on your gender possibly.
As you pointed out, your age, adolescents clearly are not
getting enough access to treatment services. Average is 50
percent lack of access. But if you are a woman, 60 percent of
women don't get access, and you are an adolescent, 80 percent
don't get access. So clearly that continuum needs to be
repaired.
But then I think there are great models out there for every
type of treatment, and clearly methadone and buprenorphine
look--methadone has a track record of 20 years; buprenorphine
looks like it could really be an incredible addition to the
medications tool box. But again, we don't have a lot of
reimbursement for those types of services. We don't have a lot
of reimbursement for residential treatment services. That is
something that both increased public funding and increased or
achieved parity in alcohol and drug treatment coverage in
private insurance could really repair.
So clearly the gaps are all over the place, but
particularly heightened for certain clients. And you have
identified, you know, heroin addicts as one of those types of
clients who don't get ready access to services. Only at most a
quarter of those with heroin addiction are really getting
treatment.
Mr. Brown. Dr. Kosten, you have--my understanding is you
have done pretty extensive research on developing a vaccine for
nicotine addiction. Tell us in a couple of minutes briefly
about that.
Mr. Kosten. The vaccine we have studied so far is for
cocaine primarily. There is a nicotine vaccine under
development. It has not made it past animal study so far. So
the nicotine vaccine, the hope is, will be within a year into
some human studies. It may well be tested initially in Great
Britain rather than the United States though, because that is
where the company has moved to.
Mr. Greenwood [presiding]. I would like to follow up on the
chairman's line of questioning and also address my comments and
questions to Dr. Alexander. For starters he read some of your
very poignant testimony, and I want to read another brief
section where you wrote, ``heroin blocks your gag reflex so
that when you start to vomit, your epiglottis doesn't fall down
to protect your airway. Instead your stomach contracts and
empties your stomach contents into your throat where it all
slides down into your lungs. In a few minutes your lungs fill
up, and you drown in your own vomit right in front of
everybody.'' That is pretty poignant.
Dr. Kosten made reference to the fact that adolescents and
young people think they are immortal. We all know that that is
actually not true. It is more subtle than that. Adolescents
don't recognize the risks, or they think they can beat the
risks. They don't think of consequences. But they don't step in
front of freight trains. They don't jump off of the roofs. They
don't really think they are immortal, and they don't really for
the most part want to die. They just make dumb decisions for a
lot of reasons having to do with immaturity, but also having to
do with lack of good information. And I share the chairman's
frustration that somehow the greatest power on Earth can't
figure out how to let our kids know this basic health
information.
And a couple of questions. One of them is we have recently
stepped up funding for public service announcements, and we
have the famous one of the young lady with the frying pan in
the kitchen, which I happen to think is no good, because I
don't--when I watch that, I don't think of that young lady as
looking terribly--I mean, she is making a mess, but she doesn't
look terribly to me like she is like this.
So one of the questions I have for anybody who would want
to respond to it is what do you think of the PSEAs that we are
spending whatever we are, $190 million a year on so far. In
terms of their effectiveness, do you think that PSEAs that are
more graphic like this stuff would be more useful?
And a related question. We have a safe and drug free school
program. We spend millions of dollars. We send money to the
schools all over the country for their programs. We are just
about to reauthorize that, and I have some serious questions
about its effectiveness. And I would be inclined to say if Dr.
Alexander has made a documentary and can put it on--I would
like the Federal Government to buy your documentary and tell
every school in America, if you want a dollar for a safe and
drug free school, you got to show this, so we have some
confidence that we are getting the right message, if that is
the right message, to kids.
So it is a broad couple of questions, but if anyone would
like to respond.
Mr. Schuster. Well, I am going to respond in the following
way, and that is that I don't think, and with all due respect
to Dr. Alexander, that we should have any intervention that is
not fully tested, rigorously tested, for its ability to, in
fact, have the effect that we want it to. Many, many years
ago----
Mr. Greenwood. Of course, these PSAs have not been
rigorously tested?
Mr. Schuster. Right. In many instances they have simply
been put before focus groups, and that type of testing has been
done.
Many years ago we would have to look back at this data very
carefully. Drug information, the truth about drugs, the facts
about drugs was portrayed to students across the United States.
That was found to be counterproductive. In other words, simply
information per se about the fact that heroin will produce
vomiting, at least many times initially in novice users, the
fact that it has effects on the brain, et cetera, that
information alone was not found to be effective. We need more
than that.
What I would like to say to you is that there is no single
pathway to addiction. There is no single reason why an
adolescent gets involved with heroin. There are a variety of
reasons. We know that there are a variety of different risk
factors. The National Institute on Drug Abuse has done studies.
We know that there are certain types of comorbidities in
children, such as attention deficit hyperactivity disorder in
conjunction with conduct disorder gives you about a 3.5fold
increase in risk that this child is going to start using these
drugs. If we don't deal with those problems, then obviously we
have children at risk.
Second, and I think this is very important, research
studies at Johns Hopkins University have shown that failure to
learn to read in the first grade sets up a situation in which
children find school to be adversive, to be unrewarding, to be
simply a place that they want to escape from, and the
trajectory of their life gradually becomes deviated that they
go off more and off into antisocial behaviors, start
associating with older children who are using drugs, dropping
out and so forth.
So I think that we have got to broaden our perspective
about prevention to look at both comorbid psychiatric
conditions as well as some of the things that turn children off
to becoming involved in activities which will compete with
their thinking about drugs. The research in that area is very
clear that you have got to have alternatives that engage kids
so when they get up in the morning, they have something
interesting to think about to do that day and be involved in
that. That is the best prevention model.
Mr. Alexander. I agree 100 percent. We try to hit a medium
in which the young people today are receptive. I think the
information that he was referring to done several years ago was
at a time when the young people in this country were less tied
into the media, being music and entertainment.
What I do when I talk with young people, the stories that I
wrote down for you, I tell. I get into it. I go dressed like
the kids. I go in shorts, sandals and my baseball cap
backwards. When it is hot, I go in my ratty T-shirt, and I talk
with them. I give them an opportunity to ask me questions, and
I present the information in street slang, which I know that
they understand what I am saying. When I talk with many of
these kids, they are the ones that bring up these PSAs. They
laugh at some of them.
I really applaud the effort in trying to get the message
across, because I think many times the message does get across
to adults. But you can't tell me that a 15-year-old boy sits
there and watches this 4-year-old girl coloring and gets the
underlying message about what did your mom tell you about
drugs. Kids don't tie into that. Kids have a whole different
agenda for their own education. We have to meet them at their
level. We don't talk down to them. We have to meet them and
talk with them, not at them, and that is very hard to do in any
kind of regimented study protocol. It is much more effective
one on one, which delves back to being good parents and good
communities, setting the examples to begin with, working on all
of the psychosocial impact that affects the child as they are
growing up. I don't think that there is any one right answer; I
think there are multiple right answers. I think we have to find
the right formula to make it work.
Ms. Collier-McColl. I would like to echo Dr. Schuster's
comment, when you give children life skills, they tend to do
better in terms of resisting drug use.
There is actually a program called the life skills program
in effect for over 16 years and has incredible outcomes because
it gives kids the skills to resist peer pressure. It gives them
confidence and leadership, and they are able to develop the
interests in life and the skills in life to really go forward
and not be sidetracked into addiction. Focusing dollars on
those types of programs and supporting programs which do those
types of things is a very good place to start when we invest in
prevention.
I am troubled by the scare tactics I have seen used
sometimes, and I am not just commenting about ONDCP's program,
but when we just use scare tactics, people tend to shy away. It
is very stigmatizing to this disease that that is the first
place we go when we think of people who are addicted. We need
to reduce that stigma and focus on positive messages and giving
kids positive alternatives to just using drugs or feeling that
is the only thing they can do, to sell drugs to get ahead in
life.
Mr. Greenwood. Mr. Barrett for questions.
Mr. Barrett. Thank you.
Not to turn this hearing into a hearing on the ONDCP ad
campaign, but there is $190 million in it. I met with some
teenagers in my district, and I watched some of the commercials
to get their reactions, and some of them they reacted favorably
to. Actually I think they liked the one with the girl with the
frying pan, but some of the playground ones that they thought
were immature, juvenile. When I talk to the people from ONDCP,
they said that is because those are geared to 10- and 11-year-
olds. Their argument, of course, is that part of the problem is
that adults don't take the time to talk to their kids about it.
They don't think that it is a problem. They may be embarrassed
by what they did 25 years ago, or they may simply think that
their kids are nice suburban kids who would never get involved,
so why talk about it.
Are we wasting our money with that program?
Mr. Kosten. I have a way of sticking my head in the noose,
which I seem to enjoy. First off, let me thank you for the
correction for the hyperbole that, yes, adolescents won't jump
off buildings or in front of freight trains, I agree.
The other issue, if you will forgive me moving back to
around what I thought the hearing was about----
Mr. Barrett. First on the ad campaign, is it a waste of
money?
Mr. Kosten. I think $190 million spent on that type of ad
campaign doesn't target the group with the problem. If you want
to think about heroin as the problem, there are 12-year-olds
using heroin. If you tell a 12-year-old we would like you to
get a methadone maintenance program, that has got to be the
worst thing that you can possibly do. First, they increase
their connections to adults who have much better access to
heroin. Second, many of the people there have substantial
criminal justice records, and so you will teach the 12-year-old
how to do crime.
Mr. Barrett. Do any commercials do that?
Mr. Kosten. What the commercials are addressing is keeping
kids away from soft drugs, presumably.
Mr. Barrett. Not the girl with the frying pan?
Mr. Kosten. What drug are they going to compare that to?
Probably marijuana. And when they smoke marijuana, they are not
convinced that it fries their brain or anything else.
I think that is one of the complaints with the ads from 100
years ago or 50 years ago of overdramatizing the effects,
particularly if you take something like marijuana. And I think
there is something that the way that the drug is being used or
acted as if they are homogeneous, and that is the problem with
the campaigns.
Mr. Anderson. I can tell you from the experience of the
state AOD directors, referral calls and calls seeking
information on where treatment is available have gone up
substantially. So it is creating interest from that
perspective.
Mr. Barrett. Any other thoughts?
Dr. Alexander.
Mr. Alexander. I had a chance to talk with Mr. McCaffrey
about this, and he was using his criteria whether this was
successful or not was the number of phone calls that they have
gotten. For me it is hard to equate that type of success with
actually getting to the children that are using.
I don't know of a better way to do this. I think it has to
be a multifaceted approach as far as adult ads, for children,
younger children. But when the kids laugh at these ads, or it
goes over their heads to the importance of what they are trying
to say, sometimes I am not sure that $190 million might not be
better invested in some type of program that works directly
with the children who have a problem.
Mr. Schuster. I can tell you at the University of Kentucky
there is a specific group that comes from the journalism
department who are experts in what is called persuasive
communication. They have developed a series of drug prevention
ads for both radio and tested them in a novel way because
Kentucky has mountains, and you can put a radio station on one
side of the mountain as your intervention group, and on the
other side the radio waves don't get over there, and you can
study the kids on the other side of the mountain and see
whether or not drug use changes. So it is a nice control that
they have introduced in that way.
They have targeted these messages, as was suggested, to
specific groups of kids who are at risk, children who have very
high sensation-seeking scale scores that we use for testing
that are more prone to initiate drug use than those who are low
on sensation seeking. So they have specifically tested these
ads and developed them to get at appealing to kids who are high
in sensation seeking and found them to be much more effective
because they are targeted to them as opposed to targeting them
to just the average kid out there.
I think there is a developing science to this, and I would
hope that whatever national ad campaigns that are being used,
that they look at that science base in order to improve their
efficacy.
Mr. Barrett. To get to your concern about this actual
hearing, and implicit in what you were starting to say is that
this bill might be responsive because people don't go to a
methadone clinic where they might be exposed to other people
who are not successful, but in a physician's office, if they
can receive this treatment there, it removes some of the
stigma, and it is done very privately.
I think the frustration some of us may have is a concern
that this would be it, that we would do this bill and that
would be the end of it. We would say we are great politicians,
we solved the drug problem, and we would run these commercials
and say that we supported the Drug Treatment Act of 1999, drug
addiction will end, and we would be lying. I think that is why
the reauthorization of SAMHSA is important as well.
I think many of us look at this legislation and say, yes,
this is well-meaning. This has some good attributes. There
might be some problems with preemption of State law. Viewed in
the context of a larger reauthorization bill of SAMHSA, yes,
this could be a component. But we don't want to be sold fool's
gold, and I am not saying that this is fool's gold, this bill
does have good things in it, but I don't think that we would be
doing a service if we said that the 106th Congress addressed
the drug problem by passing this bill, because I don't think
many of us who in our communities might have this problem in a
more severe way would say, well, this is good. This is good for
someone who has insurance, who can go to a private physician
and can have this handled discreetly, the suburban person, and
that person should get the treatment, but the women that you
talk about that don't get the treatment, the inner-city women,
the young people, I want them to have access, and I don't know
that this bill does much for that.
I will vote for this bill most likely when it comes up, but
I don't want you to leave here and think, well, that took care
of the problem.
Mr. Greenwood. The gentleman's time has expired.
We thank the panel for testifying. I think clearly drugs
are a multifaceted problem requiring multifaceted solutions,
and we hope that this is useful.
Mr. Rivers, we thank you for your courage and honesty for
coming here, and we wish you the best for your continued
rehabilitation.
This hearing is adjourned.
[Whereupon, at 11:30 a.m., the subcommittee was adjourned.]
Prepared Statement of the Salvation Army, Adult Rehabilitation Center
Services
Mr. Chairman, Distinguished Members of the Committee, Ladies and
Gentlemen: The Salvation Army is dedicated to caring for the poor,
feeding the hungry, clothing the naked, loving the unlovable and
befriending those who have no friends. The dedication has produced an
international network of helpful ministries.
The most widely known of all Salvation Army services are the Adult
Rehabilitation Centers. They comprise the largest residential
rehabilitation program in the United States. Men and women with
identifiable and treatable handicaps, resulting from alcohol and
chemical dependency, come to these centers for help when they are no
longer able to cope with their problems. They receive adequate housing,
nourishing meals, medical and recovery education and engage in work
therapy. They have the benefits of group therapy, spiritual guidance
and skilled counseling in clean and wholesome surroundings. Residents
may be referred or remanded by the courts.
The most important component of the Salvation Army's Adult
Rehabilitation Services is work therapy. It has been well established
that successful recovery will include removal of the individual from
the drug culture and integration into a supportive, drug-free culture.
Work therapy provides many of the support needs that the person who is
rehabilitating from addiction or other problems requires to start on a
path to lifelong recovery.
Work Therapy is the central component to the rehabilitation
program, but the programs also have other essential elements. The
staffs are well trained, the service usually includes long term
residential service, and beneficiaries (clients) are encouraged to take
a holistic approach and to address their medical and psychological
needs. The Centers provide individual and group counseling, 12 Step
groups, family counseling, chemical dependency education, re-entry
counseling and guidance, social skills development, vocational training
and counseling, transitional living opportunities, recreational and
leisure time activities, and, HIV education and testing and special
issues groups.
Some Salvation Army Corps Centers also offer recovery services,
although substance abuse recovery is not always the primary, or a
universal, service of the system. These recovery services include
Salvation Army Social Model Detoxification Units. Some Salvation Army
Programs are the recipients of numerous drug treatment and prevention
grants for research into the effectiveness of various strategies for
rehabilitation or addiction. We are also on the forefront of
advancements in the field, anxious to provide our residents and clients
with, as many safe, effective options for addiction recovery as are
available.
Not every person with a history of substance abuse will be
successfully lead onto the pathway to recovery. Not all clients are
helped by a Twelve Step approach, just as not all are helped by
pharmacological interventions. Simply put, one-sized does not fit all.
Furthermore, most treatment professionals agree that a variety of all
approaches should be available. The challenge lies in developing and
implementing new approaches and doing our best to stay abreast of
advancements in addiction medicine and ensure that our clients are
receiving the latest standard of care.
While success does not happen overnight, most that come to the
centers do succeed with God's help. In the follow-up period (six months
after graduation from a center), results show:
57 percent drink less.
50 percent have good jobs (with almost double their previous
earnings).
25 percent show total sobriety.
Good social adjustment and steady employment.
Today the Commerce Committee is considering amending a law that
restricts treatment options. The Narcotic Addiction Treatment Act
limits the providing of treatment for narcotic addiction, such as
heroin, to a clinic setting. However, we believe that treatment should
not be restricted to a single environment, such as the methadone
maintenance clinic setting.
If new, safe and effective treatments for addiction disorder were
made available to the treatment community, it is our belief that those
treatments should not be restricted to being dispensed through a system
of clinics similar to the methadone clinic system that currently
exists.
The Salvation Army has always been on the forefront of alcohol and
drug rehabilitation. Advancements in science and medicine will very
likely result in treatments for addiction disorders that the Salvation
Army would see as being consistent with our overall philosophy and
Christian values. We hope that when these medical advancements are made
available that we will be able to choose to provide these medications
where appropriate. We thank the Committee for considering this
important issue and for examining barriers to the provision of adequate
treatment and rehabilitation services to those who seek them.