[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
DATE RAPE DRUGS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
OVERSIGHT AND INVESTIGATIONS
of the
COMMITTEE ON COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
MARCH 11, 1999
__________
Serial No. 106-7
__________
Printed for the use of the Committee on Commerce
U.S. GOVERNMENT PRINTING OFFICE
55-638CC WASHINGTON : 1999
------------------------------------------------------------------------------
For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
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 Oversight and Investigations
FRED UPTON, Michigan, Chairman
JOE BARTON, Texas RON KLINK, Pennsylvania
CHRISTOPHER COX, California HENRY A. WAXMAN, California
RICHARD BURR, North Carolina BART STUPAK, Michigan
Vice Chairman GENE GREEN, Texas
BRIAN P. BILBRAY, California KAREN McCARTHY, Missouri
ED WHITFIELD, Kentucky TED STRICKLAND, Ohio
GREG GANSKE, Iowa DIANA DeGETTE, Colorado
ROY BLUNT, Missouri JOHN D. DINGELL, Michigan,
ED BRYANT, Tennessee (Ex Officio)
TOM BLILEY, Virginia,
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Adatsi, Felix, Toxicology Unit, Michigan State Police........ 39
Bane, Paul, Drug Enforcement Command, Maryland State Police.. 38
Dyer, Jo Ellen, Assistant Clinical Professor of Pharmacy,
University of California at San Francisco Bay Area Regional
Poison Control Center...................................... 34
Engel, Patti, Orphan Medical, Inc............................ 88
Faistenhammer, G. Mark, Detective, Grosse Ile Police
Department................................................. 26
Jackson-Lee, Hon. Sheila, a Representative in Congress from
the State of Texas......................................... 13
Maher, Patricia L., Civil Division, Department of Justice.... 54
Porrata, Trinka, D., designer drug consultant................ 29
Pruett, Candace, accompanied by Lugene Pruett, Commonwealth
of Virginia................................................ 24
Reuter, Nicholas, Associate Director, Domestic and
International Drug Control Office of Health Affairs, Food
and Drug Administration.................................... 66
Snyder, Denise, DC Rape Crisis Center........................ 42
Woodworth, Terrance W., Deputy Director, Office of Diversion
Control, Drug Enforcement Administration................... 58
Zukin, Stephen, Director, Clinical and Services Research,
National Institute on Drug Abuse, National Institutes of
Health..................................................... 73
Material submitted for the record by:
Meyers, Abbey S., President, National Organization for Rare
Disorders, prepared statement of........................... 99
Plaisier, Melinda, Interim Associate Commissioner for
Legislative Affairs, Department of Health & Human Services,
letter dated April 27, 1999, enclosing response for the
record..................................................... 100
(iii)
DATE RAPE DRUGS
----------
THURSDAY, MARCH 11, 1999
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Commerce,
Washington, DC.
The subcommittee met, pursuant to notice, at 9:30 a.m. in
room 2322, Rayburn House Office Building, Hon. Fred Upton
(chairman) presiding.
Members present: Representatives Upton, Burr, Whitfield,
Bryant, Bliley (ex officio), Klink, Stupak, Green, McCarthy,
Strickland, DeGette, and Dingell (ex officio).
Staff present: Alan Slobodin, majority counsel; Chuck
Clapton, majority counsel; Jason C. Foster, legislative clerk;
and Chris Knauer, minority investigator.
Mr. Upton. Welcome, everyone. Today this subcommittee will
hear testimony and gather facts on a growing public health and
safety problem, so-called date rape drugs.
I want to particularly thank full committee Chairman Tom
Bliley for supporting this hearing. I also want to recognize
and thank our colleagues Sheila Jackson-Lee and Bart Stupak for
their early leadership that they have shown on this issue, and
our ranking member, Ron Klink, for his genuine concern that I
know he shares about this growing problem.
The reality of this problem hit me hard several weeks ago
when I heard about what happened to two young women in my home
State of Michigan. While they were at a party, their beverages
were laced with GHB, probably without their knowledge.
Tragically, 15-year-old Samantha Reid and her friend lapsed
into a coma, and Samantha died.
I am the father of an 11-year-old daughter, and I can only
imagine what Samantha's family and friends have endured, and I
want to join with Sheila Jackson-Lee and Bart Stupak for what I
hope every member of this subcommittee today will do in
committing themselves to doing whatever they can to prevent
tragedies like this from occurring in the future, for I cannot
imagine a worse nightmare for any parent.
What are date rape drugs? Date rape drugs are a popular
reference to lethal street drugs that people may use to get
high or to incapacitate women and make them utterly vulnerable
to sexual assault. These drugs can induce a deep, anesthetic-
type sleep.
We know many drugs are used to facilitate rape, but the
most commonly encountered drugs in drug-facilitated rapes are
GHB, Ketamine, and Flunitrazepam. The victim blacks out,
experiences amnesia, and by the time the victim wakes up and
gets to the hospital, it may be too late to detect even the
presence of the drug because the drug moves so rapidly through
their system.
I want to clarify that date rape drugs are in many cases a
misnomer. They may be used by near strangers or others to
incapacitate young women.
A few years ago, Rohypnol, a prescription anesthetic drug
sold in many foreign countries, was the leading date rape drug.
Thanks to restrictions on its import, Federal controls and
changes that the manufacturer made to it makes it less easy now
to abuse it as a date rape drug. Rohypnol no longer is a big
part of the problem. Now it is GHB, and to some extent
Ketamine, which are the leading date rape drugs.
What makes GHB a particularly fast-growing problem is the
availability of its ingredients: hundreds of Internet sites. In
fact, we have an example here, a demonstration. Maybe if we can
just dim the lights? Darlene, can you just--thanks.
Hundreds of Internet websites promoting GHB and others
offer ingredient kits and recipes for making it and the
difficulty in detecting this drug. Neither GHB nor Ketamine is
under Federal control.
The DEA has documented over 3,500 overdoses in law
enforcement encounters with GHB and more than 32 GHB-related
deaths since 1990. According to the Drug Abuse Warning Network,
GHB-related hospital emergency department episodes increased
from 20 in 1992 to 629 in 1996. Clearly the status quo is
entirely unacceptable.
In today's hearing, I want us to focus on what additional
steps should and could be taken at the Federal and State levels
to protect our vulnerable young people from the vile misuse of
these substances.
We have impressive witnesses to assist the subcommittee
with its fact finding. We will hear first from Sheila Jackson-
Lee, our colleague from Texas, who has introduced legislation
in response to the death of a 17-year-old girl in her district
who died as a result of unintentionally drinking GHB, which was
poured into her soft drink. I look forward to working with
Congresswoman Sheila Jackson-Lee on this issue and others.
We will then hear from a panel of witnesses offering
various perspectives on the problem. Those perspectives will be
those from victims, victim advocates, law enforcement and the
medical community. We will hear from experts representing the
Department of Justice, DEA, the Food and Drug Administration
and the National Institute on Drug Abuse.
Finally, we will hear from Orphan Medical, Inc., a company
developing a GHB derivative drug in clinical trials for the
terribly debilitating symptom of narcolepsy. They are concerned
that if GHB was scheduled as a I or II drug, it would be
impossible for them to continue their research.
I appreciate the support of my colleague, Ron Klink, for
holding this hearing, and I look forward to working with him
and everyone else on this issue, and I will, in his stead as
acting ranking member of the subcommittee, recognize Bart
Stupak for an opening statement.
[The prepared statement of Hon. Fred Upton follows:]
Prepared Statement of Hon. Fred Upton, Chairman, Subcommittee on
Oversight and Investigations
Today, the Subcommittee will hear testimony and gather facts on a
growing public health and safety problem: so-called ``date rape''
drugs. I want to thank full Committee Chairman Tom Bliley for
supporting this hearing. I want to recognize and thank our colleagues
Sheila Jackson-Lee and Bart Stupak for the early leadership they have
shown on this issue and our ranking member, Ron Klink, for the concern
I know he shares about this growing problem.
The reality of this problem hit me hard when several weeks ago I
read about what happened to two young women in my home state of
Michigan. While they were at a party, their beverages were laced with
GHB, probably without their knowledge. Fifteen-year-old Samantha Reid
and her friend lapsed into comas, and Samantha died.
I am the father of an eleven-year-old daughter, and I can only
imagine what Samantha's family and friends have endured. I want to join
with Sheila Jackson-Lee and Bart Stupak and what I hope will be every
member of this Subcommittee today in committing ourselves to doing
whatever is necessary to prevent tragedies like this from occurring in
the future.
What are ``date rape'' drugs? ``Date rape'' drugs are a popular
reference to lethal street drugs that people may use to get high or to
incapacitate women and make them utterly vulnerable to sexual assault.
These drugs can induce a deep, anesthetic-type sleep. We know many
drugs are used to facilitate rape, but the most commonly encountered
drugs in drug-facilitated rapes are GHB (gamma hydroxy butyrate),
ketamine (a veterinary drug), and flunitrazepam (trade name
``Rohypnol''). The victim blacks out, experiences amnesia. By the time
the victim wakes up and gets to the hospital, it may be too late to
detect the presence of the drug because the drug moves so quickly
through the bloodstream or urine. I want to clarify that ``date rape''
is in many cases a misnomer. They may be used by near strangers or
strangers to incapacitate young women.
A few years ago, Rohypnol, a prescription anesthetic drug sold in
many foreign countries, was the leading ``date rape'' drug. Thanks to
restrictions on its import, federal controls, and changes that the
manufacturer made to make it less easy to abuse as a date rape drug,
Rohypnol is no longer a big part of the problem. Now, GHB, and to some
extent, ketamine, are the leading ``date rape'' drugs. What makes GHB a
particularly fast-growing problem is the availability of its
ingredients, the hundreds of internet web sites promoting GHB and
offering ingredient kits and recipes for making it, and the difficulty
in detecting the drug. Neither GHB nor ketamine is under federal
controls. The Drug Enforcement Administration has documented over 3,500
overdoses and law enforcement encounters with GHB and 32 GHB-related
deaths since 1990. According to the Drug Abuse Warning Network, GHB-
related hospital emergency department episodes increased from 20 in
1992 to 629 in 1996.
Clearly, the status quo is entirely unacceptable. In today's
hearing, I want us to focus on what additional steps should and could
be taken at the federal and state levels to protect our vulnerable
young people from the vile misuse of these substances.
We have impressive witnesses to assist the Subcommittee with its
fact finding. We will hear first from Congresswoman Sheila Jackson-Lee,
who has introduced legislation in response to the death of a 17-year-
old girl in her district who died as a result of unintentionally
drinking GHB which was poured into her soft drink. I look forward to
working with Congresswoman Jackson-Lee on this issue.
We will then hear from a panel of witnesses, offering various
perspectives on this problem. Those perspectives will be those from
victims, victim advocates, law enforcement, and the medical community.
We will hear from experts representing the Department of Justice,
the Drug Enforcement Administration, the Food and Drug Administration,
and the National Institute on Drug Abuse.
Finally, we will hear from Orphan Medical, Inc., a company
developing a GHB-derived drug in clinical trials for a terribly
debilitating symptom of narcolepsy. They are concerned that should GHB
be made a schedule 1 or 2 drug, it will be impossible to continue their
promising research.
I appreciate the support of my colleague, Congressman Ron Klink,
for holding this hearing. I looking forward to working with him and
everyone else on this issue.
Mr. Stupak. Thank you, Mr. Chairman, and thank you for
holding this hearing.
I was interested when I read the subject of this hearing in
the briefing memo because it says, and I quote, ``The
subcommittee will examine the problem of date rape drugs and
considering whether the Federal Government is adequately
responding to this serious problem.''
Mr. Chairman, I agree the Federal Government is not
responding to this problem in an adequate fashion, but I
believe much of the blame falls on Congress. As my colleagues
know, I have taken a special interest in law enforcement issues
due to my background as a Michigan State police trooper. This
interest has led me to chair both the Law Enforcement Caucus
and the Democratic Crime Task Force.
On May 21, 1997, I introduced H.R. 1699, the Families First
Juvenile Offenders Control and Prevention Act of 1997. This
bill was co-sponsored by Ms. Jackson-Lee, as well as a number
of other members. The bill included a provision that would have
scheduled GHB and Ketamine as Schedule III controlled
substances.
Then again on June 8, 1997, I introduced a provision on
date rape drugs as a stand-alone bill because of the attention
that this issue needed. Ms. Jackson-Lee introduced her own bill
in May that would have also scheduled these drugs as Schedule
I.
Mr. Chairman, I know that you were not the chairman of this
subcommittee last year, and if you had, many subcommittee
priorities would have been different. But I feel compelled to
point out that I believe that the legislation would not have
languished in the committee since mid-1997, and I wish the
majority would have done things differently to hasten its
passage. In fact, I am told that the Judiciary Committee was
willing to move Ms. Jackson-Lee's bill last year, but this
committee refused to allow the bill to the floor.
Mr. Chairman, I understand that you became aware of this
issue because of the tragic death of a girl in the district of
our colleague, John Dingell of Michigan. While we cannot be
sure her tragic death could have been prevented, actions on
these bills, my bill or Ms. Jackson-Lee's bill, may have
prevented some of the tragedies that have occurred over the
last 2 years.
Yesterday I reintroduced the Date Rape Prevention Act of
1999. We have worked with industries and others to move this
bill along. This bill would require the Drug Enforcement Agency
to schedule both GHB and Ketamine as Schedule III controlled
substances.
Second, it would increase the penalties for illegal
possession and illegal import or export of these drugs to the
Schedule I level, similar to the congressional treatment of
Rohypnol.
Third, it allows the tracking for GBL, the precursor
chemical for GHB, to ensure that it is not being used to
manufacture GHB. Congress has required similar tracking with
Ephedrine, a bill that I introduced and was passed and signed
into law in 1993, and that was with the drug Methcathadone or
``Cat'' as we knew it back then. We have basically wiped that
drug out.
Finally, it would require the Attorney General to conduct a
drug awareness campaign about the dangers of date rape drugs.
Mr. Chairman, I look forward to working with you, and I
urge you and the members on your side of the aisle to work with
Representative Jackson-Lee and myself to pass our legislation
quickly.
After this hearing, I would ask that we circulate a letter
among the members of the subcommittee to urge Chairman
Bilirakis on the Health Subcommittee to mark up our legislation
as quickly as possible.
I want to thank my colleague, Ms. Jackson-Lee, and others
for all their work on this issue. I look forward to working
with her and you, Mr. Chairman, on quick action on my proposed
legislation or any other legislation that would address this
dangerous, growing problem. Let us not wait another 2 years.
Thank you, Mr. Chairman.
Mr. Upton. At this point I recognize the chairman of the
full committee, Mr. Bliley.
Chairman Bliley. I thank you, Mr. Chairman. I thank you for
holding this hearing. I will put my statement in the record,
but I would like to respond to the remarks of the gentleman
from Michigan.
Yes, we did oppose putting this on the omnibus bill because
the ranking member of the full committee, the gentleman from
Michigan, Mr. Dingell, contacted me about many proposals that
were being suggested for the omnibus bill last fall that fell
in the jurisdiction of this committee and urged me to oppose
all of them.
Therefore, I thought I was carrying out the wishes long
held by this committee in the 19 years I have been on here, 14
of them in the minority.
Mr. Stupak. Would you care to----
Chairman Bliley. I will not at this time. I will not. I
listened with great dismay to the gentleman's remarks, and he
can listen to mine. Thank you.
We have traditionally refused. I wanted to bring the
satellite bill up last week at full committee, but at the
insistence of the ranking member, who insisted on regular
order, we went through the subcommittee.
We need to know more about this bill. We had had no
hearings. Therefore, I felt that it was the right thing to do,
and I am happy to be here today, and I will do what I can to
encourage the chairman of the subcommittee to schedule hearings
and bring the bill for mark-up as soon as possible.
Thank you. I yield back the balance of my time.
[The prepared statement of Hon. Tom Bliley follows:]
Prepared Statement of Hon. Tom Bliley, Chairman, Committee on Commerce
Mr. Chairman, thank you for holding this hearing today to expose
the growing national problem of the abuse of certain drugs to
facilitate sexual assaults on unsuspecting victims. By holding this
hearing, this Committee can hopefully bring greater public attention to
this abuse, and educate potential victims of the dangers posed by
substances that can be easily slipped into an unsuspecting person's
drink which will leave that individual unconscious a short time later.
The hearing will also focus on what the response of the Federal
government has been to the emergence of these drugs as a serious public
health concern, and what else can be done.
GHB, flunitrazepam and ketamine are all powerful sedatives, which
in certain dosages can induce unconsciousness or even death. In
addition to the risk that is posed by the misuse of these drugs by
sexual predators, misuse of these drugs for recreational abuse is also
a growing danger. The numbers of emergency room admissions for
overdoses, drunk driving accidents, and other injuries which are
related to these drugs are all increasing. In addition, some of these
drugs and their precursors can be obtained readily at local hardware
stores, gyms, or over the Internet.
I am particularly troubled by the difficulties that have been
encountered in prosecuting the abuse of these drugs. Because of the
unique characteristics associated with these drugs, including memory
loss, and the rapid breakdown of the drug in the body which makes it
especially difficult to detect, prosecutors have found it particularly
difficult to obtain convictions for those who abuse these drugs. In
response, many state and local law enforcement officials have lobbied
to have these drugs listed as controlled substances under their state
drug control laws.
To date the Federal government has not scheduled either GHB or
Ketamine. I look forward to hearing from the agency administrators who
will testify about what actions have been taken to date, and when we
can expect final actions to be taken on these drugs. Anecdotal evidence
certainly indicates that this is a growing problem which is putting
more of America's youth at risk every day. We will need to review the
adequacy of the federal government's response to this problem,
including their continuing efforts to assess the scope and severity of
this particular issue. If this review indicates that the government's
response has been insufficient, we should then consider what steps
Congress should take to address this problem.
I would like to welcome all of our panels here today to testify. I
would especially like to welcome Candace Pruett, who is from Northern
Virginia. Candace was the victim of a sexual assault when she was
fifteen years old. Her attacker had given her a soda laced with
Rohypnol, which rendered her unconscious for several hours and enabled
him to assault her. She went through a very difficult trial where she
had to recount these painful memories. I commend her courage in
testifying about this troubling event before the Subcommittee today,
which we all hope will help to educate other potential unsuspecting
victims and prevent similar assaults in the future.
Mr. Upton. The Chairman yields back the balance of his
time.
The gentlelady from Colorado?
Ms. DeGette. Thank you, Mr. Chairman. I would like to thank
you for calling this hearing today also, and I would like to
thank all of my colleagues who have introduced legislation to
address this problem, specifically Congresswoman Jackson-Lee
and my colleague, Mr. Stupak, from the committee.
The problem of date rape drugs is real and must be
addressed. The alarming incidence in reports of these drugs
being slipped into the drinks of unsuspecting women in order to
render them defenseless for sexual exploitation is disturbing.
In Colorado, for example, my home State, a woman was raped
in May of last year. Testing confirmed that someone had slipped
GHB into her drink while in a bar. Two other women reported
similar assaults within 2 months of that incident, and that is
just in one State.
GHB and similar substances are odorless, tasteless,
colorless, and they induce serious impairments in functioning,
such as drowsiness, dizziness, confusion and memory loss.
Although they are not marketable in this country for
prescription purposes, the common ingredients and recipes for
making GHB are now available on the Internet, and reports
indicate that these substances are widely available because of
the Internet availability at fraternity parties, bars and other
social gatherings.
This is a complex issue that demands an intelligent
response. When Congress passed the Drug Induced Rape Prevention
and Punishment Act of 1996, Congress made a strong statement it
wanted to find such a solution. With this law, Congress amended
the Controlled Substances Act, imposing penalties for
distributing these substances with the intent to commit a
violent or sexual crime.
We also directed the DEA to study the appropriateness of
rescheduling Rohypnol as a Schedule I drug. After analysis and
consultation with the Department of Health and Human Services,
the DEA decided there was not sufficient rationale to
reclassify Rohypnol as a Schedule I drug.
Indeed, the company that produces that drug has made
changes in the product to prevent it from being used as a drug
for sexual assault. For example, the drug turns blue when it is
put into a drink, and it has a salty taste so that people can
tell it is being put into the drink.
We applaud such steps to try to address the crisis, but it
is pretty clear with the increase of these drugs being used
that more needs to be done. That is why we are here today.
There are other drugs that are misused to rape women; as I
discussed, GHB, and Ketamine. Representative Jackson-Lee
introduced a bill to reschedule these substances I believe
under the Controlled Substances Act as Schedule I substances.
The bill was referred to committee, but died, as Congressman
Stupak said.
I think it is time for this Congress to act. I think it is
time for this Congress to act swiftly because with the Internet
availability, more and more young women are becoming subject to
date rape for this reason, and we need to do something to
figure out how we can stop the illegal distribution of these
drugs and we can stop these practices.
With that, Mr. Chairman, I will yield the balance of my
time to our acting Chairman, Mr. Stupak, who would like to
follow up on his previous statement.
Mr. Stupak. Thank you, and thank the gentlelady for
yielding.
I want to make it very clear. The Jackson-Lee bill was not,
nor was it ever requested to be, part of the omnibus bill that
we were working on in late October. It was a freestanding bill.
We requested it to be a freestanding bill while we sat here
for 2 weeks twiddling our thumbs while they put together the
omnibus bill, and we had Judiciary to sign off. There was not a
request to Mr. Dingell that this bill be part of the omnibus
bill.
We wanted to do a freestanding bill while we were here. As
everyone on this side of the dais knows, we did plenty of bills
in the 2 weeks while we were waiting for the omnibus bill.
The point is there has been plenty of time to move our
legislation. We get people to sign off, and it gets
bottlenecked here. I want the bottleneck to stop, and I want to
move forward so we can move this legislation.
Ms. Jackson-Lee has worked with industry and others to get
her bill in good shape. My bill was in good shape. We
introduced it last night after we got the last of industry to
sign off. We are ready to go. Let's move these bills forward.
I would yield back to the gentlelady and thank her for the
time.
Ms. DeGette. And I will yield back the balance of my time,
Mr. Chairman.
Mr. Upton. The gentlelady's time has expired.
Vice-Chairman of the committee, Mr. Burr, from North
Carolina?
Mr. Burr. Mr. Chairman, I thank you, and my colleague, Ms.
Jackson-Lee, thank you for committing your time to come up.
Hopefully we have gotten the name blame out of the way, and now
we can all look forward to learning more about the problem,
but, more importantly, more about the solution.
I think it was in 1996 that Congress responded to an
imminent problem of date rape. I appreciate my colleague from
Colorado pointing out the fact that some companies have been
responsive. Hoffman LaRoche did everything they could to help
tighten controls over certain products.
Congress also passed legislation at that time that I am
convinced today, after reading back on it--I was here, but the
intent was to eliminate this problem, and it did not. I think
that is one of the reasons that hopefully this oversight
hearing might be just the start of some additional hearings on
what is the appropriate answer.
I think one of the things that alarms me, and I hope that
Mr. Stupak will be as vicious with his questions to the FDA, is
that they made a recommendation for scheduling to FDA in 1997
to set a scheduling change at that time for GHB. Unfortunately,
I do not think that that has taken place yet, Mr. Chairman. If
it did, it is only recently.
We have a system that we thought would be responsive.
Clearly there are areas of it that have been not effective or
have broken down. I hope that through the efforts of some of
our colleagues like Ms. Jackson-Lee and others who are
passionate about this that in fact we can ensure all Americans
that Congress has done everything within its power to make sure
that this is not a problem and that the system does work.
I thank the chairman for these hearings. I yield back.
Mr. Upton. The gentleman from Pennsylvania, the ranking
member of the subcommittee, Mr. Klink?
Mr. Klink. I thank my friend, Mr. Upton, and I apologize. I
had another meeting this morning, so I am delayed a little bit.
I thank my friend, Mr. Stupak, for filling in. I know how
important this issue is in his legislative office because he
has seen the problems up in Michigan. I know he has been
working very hard on this.
I want to thank the chairman, Mr. Upton, for realizing that
this was such an important issue and for conducting this
hearing. It has been a pleasure to work with him on this. We
think that something really should have been done earlier, but
I am glad that the chairman has really taken the bull by the
horns and moved forward on this, and we look forward to working
with him.
Can I ask you, my dear colleague, Ms. Jackson-Lee? In your
opinion, what is more dangerous, the----
Mr. Upton. Mr. Klink, we are doing opening statements.
Mr. Klink. We are doing opening statements? I am sorry. You
are going to have to really bear with me. I thought we were
actually on questions.
I was listening to the engaging way in which Mr. Burr was
responding, and I thought that we were at a question time.
Mr. Chairman, I, too, want to applaud you for having this
hearing on date rape drugs. Sadly, the manufacture and use of
GHB has recently become a problem for law enforcement
authorities in my own State of Pennsylvania where authorities
seized enough chemicals and packaging for thousands of doses of
GHB, only to discover the drug is not illegal under Federal or
Pennsylvania law.
The sooner we take action to make these date rape drugs
more difficult to obtain, the better, and I hope that this
hearing will help us do that.
There are two drugs under question for today's hearing:
Ketamine and GHB. Both have been scheduled by a number of
States, but have not been scheduled by the Federal Government.
In that regard, today's hearing is more than about date rape
drugs. It is also about what actions we in Congress should be
taking to control these drugs.
While I fully support the efforts of the Oversight and
Investigations Subcommittee to look into this important matter,
I wish that we could do it jointly with the Subcommittee on
Health and Environment so we could mark up one of these bills
that have been introduced so that we could schedule Ketamine or
GHB as quickly as possible because I think they are very
dangerous.
The fact is that this issue is not entirely new. During the
past Congress, no fewer than seven bills were submitted by
Democrats to schedule Ketamine and/or GHB. In fact, two of
those bills were referred to this committee. One, authored by
my good friend Sheila Jackson-Lee, who is with us, and the
other by my good friend Bart Stupak, was referred to the
Commerce Committee almost 2 years ago. We did not take any
action.
I am glad that we have both of these people here today, and
I look forward to working with both of them and with Chairman
Upton on this issue. I cannot really blame any inactivity on my
dear friend, Mr. Upton. He in fact is the reason that we are
here today. He realized the importance of this. He was not at
the helm of this subcommittee during the last Congress, nor
were you in charge of determining, my friend, Mr. Chairman,
what bills would be scheduled by the full committee.
If anything, I have to applaud your willingness and your
conviction to shed light on a matter in which a serious
discussion by our committee is long overdue. Hopefully, this
hearing will help us move closer to taking action on either Mr.
Stupak's bill or Ms. Jackson-Lee's bill. In fact, maybe both of
our colleagues will be able to work together to come up with a
consensus bill. I would enjoy working with them on that effort
if that is what they decide to do.
I think we already realize that these drugs have been a
problem and that there must be a Federal response. Whether they
get scheduled as I, II, III, or IV is an issue that is worthy
of debate. The important thing is that we do what we have to do
to protect people from the misuse of these substances.
For today's discussion, we must understand that the Federal
scheduling of any drug is a slow process because it is a
deliberative one. To make a recommendation to schedule a
substance, the Food and Drug Administration must go through a
multitude of investigational tests. The process is highly
procedural. It requires significant data gathering and allows
for the public input by those that might be affected by the
decision.
Mr. Chairman, we may not like how long it takes the FDA or
NIDA or HHS or the DEA to do this, but that is what the law
requires. While I look forward to hearing testimony from the
FDA, so far we have seen no evidence suggesting that the FDA or
our friends at HHS have been derelict in their effort to
evaluate either GHB or Ketamine for the scheduling purposes.
Some many wonder why many States have already scheduled
these drugs when the FDA has not. The answer is a simple one.
Like our colleagues, Mr. Stupak and Ms. Jackson-Lee, have
attempted to do, most States that have scheduled these drugs
have done so through legislative fiat. That, Mr. Chairman, is
the debate that we need to have.
I am not saying that either of these bills is perfect, but
they are an excellent place for us to start. I am hopeful we
can join together and commit ourselves to moving this debate
forward.
Mr. Chairman, I will conclude by saying that because Mr.
Stupak is a former law enforcement official and has already
been very active on this issue, I intend to turn the reins of
this subcommittee ranking leadership over to him for today's
hearing. I thank him in advance for his hard work.
I also thank Ms. Jackson-Lee. She has shown extraordinary
leadership on this matter, and we are privileged to have her
here from the Judiciary Committee today.
Finally, Mr. Chairman, again I thank you for your
willingness to have this hearing. You have made a commitment to
work with us together in this new Congress to solve serious
policy matters, and I think that today's hearing, the way you
have handled it, is a great start.
This appears to be a reasonable starting point, and I look
forward to something good coming out of today's hearing.
[The prepared statement of Hon. Ron Klink follows:]
Prepared Statement of Hon. Ron Klink, a Representative in Congress from
the State of Pennsylvania
Thank you Mr. Chairman.
Mr. Chairman, I want to applaud you for having this hearing on
date-rape drugs. Sadly, the manufacture and use of GHB has recently
become a problem for law enforcement authorities in my own State of
Pennsylvania where authorities seized enough chemicals and packaging
for thousands of doses of GHB only to discover that the drug is not
illegal under Federal or Pennsylvania law. The sooner we take action to
make these date-rape drugs more difficult to obtain the better, and I
hope this hearing helps us do that.
There are two drugs under question for today's hearing: ketamine,
and GHB. Both have been Scheduled by a number of states, but have not
yet been scheduled by the federal government. In that regard, today's
hearing is about more than date-rape drugs. It is also about what
actions Congress should take to control them.
While I fully support the efforts of the Oversight and
Investigations Subcommittee to look into this very important matter, I
wish we were doing it jointly with the Subcommittee on Health and the
Environment so that we could mark-up a bill to schedule ketamine and
GHB as quickly as possible. The fact is that this issue in not entirely
new. I would be remiss if I did not point out that during the past
Congress alone, no fewer than seven bills were submitted by Democrats
to schedule ketamine and/or GHB. In fact, two of those bills, were
referred to this Committee. One, authored by my good friend Sheila
Jackson-Lee and the other by my good friend, Bart Stupak, were referred
to the Commerce Committee almost two years ago without any action being
taken. I am glad to have them both here today and I look forward to
hearing their testimony.
Mr. Chairman, I don't blame the inactivity of the Committee on your
leadership. You were not at the helm of the Oversight Subcommittee
during the last Congress, nor were you in charge of determining what
bills would or would not be scheduled by the full Committee. Rather, if
anything, I applaud your willingness and conviction to shed light on a
matter in which a serious discussion by our Committee is long overdue.
Hopefully this hearing will help us move closer to taking action on
either Mr. Stupak's or Ms. Jackson-Lee's bill. I think we already
realize that these drugs have been a problem, and that there must be a
Federal response. Whether they get scheduled as I, II, III, or IV, is
an issue worthy of debate. The important thing it that we do what we
have to do to protect people from the misuse of these substances.
For today's discussion, we must understand that the Federal
scheduling of any drug is a slow process because it is a deliberative
one. To make a recommendation to schedule a substance, the Food and
Drug Administration must go through a multitude of investigational
tests. The process is highly procedural, it requires significant data
gathering, and allows for public input by those that might be affected
by the decision. Mr. Chairman, we may not like how long it takes the
FDA, NIDA, HHS or the DEA to do this, but that's what the law requires.
And while I look forward to hearing testimony from the FDA, so far,
we've seen no evidence suggesting that FDA or our friends at HHS have
been derelict in their efforts to evaluate either GHB or ketamine for
scheduling purposes.
Some may wonder how many states have already scheduled these drugs
when the FDA has not. The answer is simple: like our colleagues Mr.
Stupak, and Ms. Jackson-Lee have attempted to do, most of the states
that have scheduled these drugs have done so through legislative fiat.
That, Mr. Chairman, is the debate we need to have. I am not saying that
either of these bills is perfect, but they are an excellent place to
start, and I am hopeful that we can join together and commit ourselves
to moving this debate forward.
Mr. Chairman, let me conclude by saying that because Mr. Stupak is
a former law enforcement official and has already been very active on
this issue, I intend to turn the reins of ranking member over to his
leadership for today's hearing. I thank him in advance for his hard
work. I also thank Ms. Jackson-Lee. She too has shown extraordinary
leadership on this matter and we are privileged to have her here today.
Finally, Mr. Chairman, I want to again thank you for your willingness
to have this hearing. You and I have made a commitment to work together
in this new Congress to solve serious policy matters. This appears to
be a reasonable starting point and I look forward to working with you
to follow it to its conclusion.
Mr. Upton. Thank you.
Mr. Whitfield from Kentucky?
Mr. Whitfield. Mr. Chairman, thank you. I am particularly
excited that you decided to have this Oversight hearing today
on this important issue as we address the continuing problem of
date rape drugs in general and the abuse of GHB and Ketamine in
particular.
The Controlled Substances Act requires the Drug Enforcement
Agency to submit data to the Department of Health and Human
Services and to request that HHS conduct a medical and
scientific evaluation of the substance in question.
GHB has no medical use, and the FDA has issued an advisory
declaring GHB unsafe and illicit. The DEA finished its
evaluation and submitted its report to HHS in 1997, and still
HHS has not come up with its findings. HHS' findings as to
scientific and medical matters are binding on DEA, so DEA
cannot move unless HHS completes its responsibility, which it
has not done.
I hope that today's hearing will provide some answers as to
why we are not taking advantage of the one aspect of the fight
against drug use in our society that is within our control, the
ability to schedule dangerous drugs.
I would like to make one more comment. This administration,
over the last 3 or 4 years, has been in the forefront of a
well-coordinated campaign to protect children from tobacco use.
We all recognize that tobacco use is damaging to children over
the long term, but as I go around my district and my State and
I talk to educators, as I talk to law enforcement people and
others, the most direct, the most immediate threat to young
people today is the proliferation of dangerous drugs, which are
easily available and readily available around the country.
I am delighted that we are focusing on some serious drug
problems facing young people in America today, and I commend
the chairman for having this hearing.
Mr. Upton. Thank you.
I would like to announce that all members of the
subcommittee by unanimous consent will have an opportunity to
insert their opening statements as part of the record.
[Additional statement submitted for the record follows:]
Prepared Statement of Hon. Henry A. Waxman, a Representative in
Congress from the State of California
Mr. Chairman, I am pleased this hearing has been called on a very
important issue. Let me preface my remarks by welcoming Mr. Upton to
the Chair. I look forward to cooperating with him on many issues in the
future.
``Date rape'' or ``acquaintance rape'' is a new name for an old and
terrible problem. More often than not, rapists are not strangers. Two
thirds of all victims of rape and sexual assault know their
assailants--their husbands or relatives, boyfriends or acquaintances.
Most appalling, the use of drugs by rapists to incapacitate their
victims may not only expedite a violent sexual assault, but also
deprive the victim of her memory of the assault.
In seeking an answer to this terrible problem, I want to associate
myself with the remarks of my colleague from Pennsylvania. Almost two
years ago, bills were introduced by our colleagues, Congresswoman
Jackson-Lee and Congressman Stupak, to help solve this problem.
Last year, the Judiciary Committee acted on Congresswoman Jackson-
Lee's bill. I think it is deeply regrettable that the Commerce
Committee did not consider Congresswoman Jackson-Lee's bill. If the
full Committee had acted as decisively as the Judiciary Committee last
year, law enforcement would probably already have an effective Federal
law at its disposal.
Let me make a final point about the substances to be discussed
today. The Food and Drug Administration will testify today. They may be
criticized for not acting more quickly or decisively to restrict access
to two of the substances being discussed today, GHB and its chemical
precursor, GBL.
I want my colleagues to understand that GHB and GBL are or were
marketed as dietary supplements. Five years ago, this Congress placed
very significant restrictions on the FDA and its ability to act against
unsafe supplements. FDA does not approve supplements or supplement
ingredients before they are marketed. FDA bears the burden in showing a
supplement is unsafe. And FDA lacks the resources to effectively police
the supplement marketplace.
Before we throw stones at FDA, I caution my colleagues that we in
Congress may live in a glass house. If anything, the problems with GHB
and GBL suggest that the FDA needs more authority and more resources
from Congress to evaluate dietary supplements and enforce the law
against unsafe supplements. I would be happy to work with all of my
colleagues on this problem in the future.
I welcome Congresswoman Jackson-Lee and the rest of our witnesses.
I look forward to their testimony.
Mr. Upton. Ms. Jackson-Lee, before you begin I have some
subcommittee business to do. You are aware that this
subcommittee is an investigative subcommittee. As such, we have
always had the long practice of taking testimony under oath. Do
you have any objection to testifying under oath?
Ms. Jackson-Lee. No, Mr. Chairman.
Mr. Upton. We also advise you per se that you are allowed
to be advised by counsel. Do you have any desire to be advised
by counsel as well today?
Ms. Jackson-Lee. Not as we begin. Maybe as we continue.
Mr. Upton. We do not reimburse for that, by the way. In
that case, would you please rise and raise your right hand?
[Witness sworn.]
You are recognized. Your statement will be made part of the
record in its entirety, and you are recognized for 5 minutes.
TESTIMONY OF HON. SHEILA JACKSON-LEE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Ms. Jackson-Lee. Thank you very much, Mr. Chairman, and
good morning to all of my colleagues.
This morning I would say how do you spell relief? You spell
it by the Subcommittee on Oversight and Investigations, chaired
by Chairman Upton, and ranking member Klink, and with the
leadership of Bart Stupak and the many, many talented members
who are here this morning who have a great interest in this
area.
I am comforted by the expertise that you offer. I note
particularly the leadership of Congresswoman DeGette on women's
issues, and I am appreciative of both Chairman Bliley and
ranking member Dingell coming together on this very important
issue.
This is the day that we should move forward, and I hope
Chairman Bilirakis will move forward under your leadership in
collaboration, Chairman Upton, on this very important point.
Why am I here today? To save lives. To save young people
and to commit to the promise that we have given to all young
people to lead a healthy life.
Let me acknowledge LPD retired police officer Trinka
Porrata, who you will hear later on, who has dedicated her life
to fighting against this unknown killer of which so many people
have not been able to get a handle on.
I would also like to acknowledge that I chair the
Congressional Children's Caucus, and we have as a mission to
promote children as a national interest.
This morning's hearing is extremely important. I do want to
acknowledge that Bart Stupak and myself have worked together on
many issues. He has a bill to schedule GHB as Schedule III. I
look forward to working with him.
As you will note, I filed in January 1997 in the 105th
Congress and now again on January 6, 1999, a G.H. bill named
after Hillary J. Farais to schedule GHB as a Schedule I drug.
I look forward, of course, to working with Mr. Stupak on
his leadership to come together. Hopefully this is a party that
will bring us all together to ultimately allow our young people
to have parties that are safe. My bill, named after Hillary J.
Farais, is a bill that would ask the Attorney General to
schedule this at Schedule I and Ketamine at Schedule II.
Particularly let me emphasize that my drug legislation also
asks the Attorney General to establish programs throughout the
United States and to disseminate materials to provide young
people in high school and college with education about the use
of controlled substances in the furtherance of rape and sexual
assault and shall assist law enforcement personnel in the
prevention of abuse of controlled substances for such purpose.
Let me just tell you that I had my bill pulled off the
Internet. I would hope that the only thing we can pull off the
Internet would be legislation and other positive instructions
to our young people, not the instructions on how to make GHB,
which can be found, as you have so noted, on the Internet. We
note that young people will make GHB in bathtubs for these rave
parties that have been very popular around the country.
As a legislator and a mother, I believe we must work to
protect our loved ones from the insidious harm resulting from
the misuse of potentially dangerous drugs. We must schedule
this drug effectively to limit the abuse of GHB and to more
efficiently prosecute those who use it for illicit purposes.
I will move quickly, but I must tell you about Hillary J.
Farais and this drug that killed a young woman, as I know many
of you have experienced in your community. I have named it
after her, H.R. 75, the Date Rape Prevention Drug Act, and I
want to tell you about her story.
Her death occurred in my home State in 1996 when Hillary J.
Farais of La Porte, Texas, died as a result of unintentionally
drinking GHB, which was poured into her soft drink at a teenage
club on August 5, 1996. On the night she died, Hillary and two
girlfriends went to a club where she consumed only soft drinks.
Our immediate response to young people is were they on
drugs? Were they drinking? We wish to sort of group them
together. She was not a drinker. She was an athlete, a
volleyball player, well loved and living with her grandmother.
Soon afterwards, as I complete my remarks, I guess, she
complained of feeling sick and having a severe headache. She
went home to bed, and the next morning her grandmother was
unable to wake Hillary. The grandmother contacted Hillary's
uncle, Raul, and she was rushed to the hospital where she later
died.
Hillary, a 17-year-old high school senior, model student
and varsity volleyball player, had died during the night as a
result of the GHB slipped into her drink. As I said, she was
not a drinker. She did not use drugs.
This is a drug that attacks the central nervous system. It
is detrimental, Mr. Chairman. It is one that has been called by
the pharmaceutical offering with a medical use.
Let me just conclude by saying that I worked extensively
with DEA. We had the support of Chairman McCullum of the Crime
Subcommittee. We worked with FDA. We started out this morning
saying that we have relief so that I will not offer to finger
point, but I will say that it is time that the Government
agencies come up to the bar, if you will and work together.
This is a deadly drug, and I would hope that we could move
FDA expeditiously to work with those of us who have sought a
compromise, and I would hope that if there is a compromise that
we would ensure that the criminal penalties for the illicit use
and selling and possession to do harm of GHB has a 20-year
penalty. We must let America know we are serious not only about
good health care, but as well in protecting our young people.
I know the other witnesses will document for you, Mr.
Chairman, the various incidents that have occurred in the use
of this drug and rapes that may not have occurred or resulted
in death. This is a tragedy. America must do something about
it.
I thank the chairman for his kindness and his indulgence
and this committee for its leadership. Thank you very much, Mr.
Chairman.
[The prepared statement of Hon. Sheila Jackson-Lee
follows:]
Prepared Statement of Hon. Sheila Jackson-Lee, a Representative in
Congress from the State of Texas
Thank you Chairman Upton and Ranking Member Ron Klink for inviting
me to testify this morning. I would also like to say that I look
forward to working with Congressman Stupak who has a bill to schedule
GHB in Schedule III. We must work together on this national problem.
This legislation has great personal importance to me. As a legislator
and a mother, I believe we must work to protect our loved ones from the
insidious harm resulting from the misuse of potentially dangerous
drugs. We must schedule this drug to effectively limit the abuse of GHB
and to more efficiently prosecute those who use it for illicit
purposes.
H.R. 75, the Hillory J. Farias, Date Rape Prevention Drug Act
amends Section 401 of the Controlled Substances Act. (21 U.S.C. 841) to
make it a federal crime to possess, distribute or manufacture GHB, and
adds up to 20 years imprisonment when the use of this drug causes
serious bodily injury or death.
This legislation is a direct result of a tragedy which occurred in
my own home state of Texas in 1996, when Hillory J. Farias, of Laporte,
Texas, died as a result of unintentionally drinking GHB (gamma
hydroxybutryate) which was poured into her soft drink, on August 5,
1996.
On the night she died, Hillory and two girlfriends went to a club
where they consumed only soft drinks. Soon afterwards, she complained
of feeling sick and having a severe headache. She went home to bed, and
the next morning, her grandmother was unable to wake Hillory. The
grandmother contacted Hillory's uncle, Raul and she was rushed to the
hospital where she later died.
Hillory, a 17 year old high school senior, model student and
varsity volleyball player had died during the night as a result of the
GHB slipped into her drink. She was not a drinker and she did not abuse
drugs.
GHB is a central nervous system depressant that is abused for its
ability to produce euphoric states. It also acts as a growth hormone
releasing agent to stimulate muscle growth. Although GHB gained early
favor with health enthusiasts as a safe and ``natural'' food supplement
sold in health food stores in the late 1980's, the medical community
soon became aware of overdoses and related problems caused by its
abuse.
In 1990, the FDA issued an advisory declaring GHB unsafe and
illicit, except under FDA-approved, physician-supervised, study
protocols. The FDA has not approved GHB for marketing, but it is
currently under investigation for use in treating narcolepsy under the
FDA's Orphan Drug program.
Although the FDA has made it illegal to import, distribute and use
GHB, the abuse of this drug has increased. As a drug of abuse, GHB is
generally ingested orally after being mixed in a liquid. The onset of
action is rapid, and unconsciousness can occur in as little as 15
minutes. Profound coma can occur within 30 to 40 minutes after
ingestion. GHB has also been used by drug abusers for its alleged
hallucinogenic effects and by bodybuilders who abuse GHB for an
anabolic agent or as a sleep aid.
GHB is known to be responsible for as many as 19 deaths and
innumerable rapes throughout this country. In seven of these cases, GHB
was detected in the urine of the sexual assault victims.
However, GHB's involvement in rape cases often goes unreported or
unsubstantiated because little is known about how to detect the
presence of the drug in victims rushed to hospitals and police
stations. GHB has been widely used as a party drug and most
horrifyingly, by those intending to drug and then rape their victims.
In California in 1996, 2 men were eventually brought to trial and
convicted of 43 counts of rape, attempted rape and conspiracy to commit
rape. These men gave their dates drinks spiked with GHB and then
brutally raped and sodomized them.
During preparation for trial, prosecutors discovered nearly 2000
photographs in one of the accused rapist's home. One of the police
officers testified that some of the women looked obviously comatose in
the pictures.
Unfortunately, this terrible story is not an anomaly. Women who are
drugged and raped using GHB, often do not remember the rape until much
later, making the evidence scarce, and prosecution of these cases a
legal nightmare.
GHB has the greatest potential for abuse as a date-rape drug
because it is more easily obtained than other drugs and can be
manufactured by amateur ``basement chemists.'' Many of young people mix
the drug with a home kit and with chemicals available at chemical
supply and hardware stores. The recipe is readily available on the
Internet.
GHB comes in liquid form and is often slipped into drinks with eye
droppers or bottle caps. Dizziness, confusion, overwhelming drowsiness,
and unconsciousness are common. GHB is colorless and odorless, but may
be detected by its slightly salty taste.
During testimony last July, law enforcement officers, doctors and
researchers agreed on the importance of scheduling GHB under the
Controlled Substances Act. I would like to thank former Detective
Trinka Poratta, of the Los Angeles Police Department; Detectives Mike
Stevens and Toni Moreschi from Orlando, Florida; and Dr. Joy Carter
from Houston, Texas for their help and encouragement in working to
schedule GHB.
This drug is currently controlled at the state level in 17 states,
including Tennessee, Alaska and North Carolina which have scheduled it
as a level 4 drug under the state controlled substances act.
I believe we must do whatever we can to protect our young people
from GHB when used improperly. I hope my colleagues will support my
efforts in preventing date rape and lethal drug overdose. Thank you.
Mr. Upton. Thank you very much. We appreciate--all of us--
your leadership on this issue.
I know you spoke on the floor again yesterday or the day
before with regard to this issue, and I just want to commit as
chairman of this subcommittee, and as a Member of Congress
representing my good State of Michigan, that we do want to see
changes made.
The purpose of this hearing is to identify some of those
abuses, find out whether legislation is needed, whether FDA can
act on its own. Those will be some of the tough questions that
we will be asking later this morning.
We just appreciate your testimony today, and with that I
will yield for purposes of questioning to Mr. Stupak.
Mr. Stupak. Just a quick question, and I am sure the
sponsor of the legislation knows while FDA has been working
with us, I am sure you understand there are two ways we can do
this.
We can either do it through the FDA and have them pass
rules or regulations, or we can do it legislatively. Is there
any preference you prefer?
Ms. Jackson-Lee. Congressman, I would relish the
opportunity for us to work together in the Congress and to move
swiftly and to do this legislatively. I think in doing so, we
would not in any way injure or damage the relationship between
the Congress and the Executive.
I think that the Congress is asked to deal with crises, and
I think we now have a point where we can assess the GHB use and
its proliferation as a crisis. I would welcome doing this
through the legislative process.
Mr. Stupak. In our conversations we have had on this issue,
it was your hope and our belief and hope, much like I did in
1993 when we did Ephedrine to wipe out the Cat problem, that we
could introduce this legislation, move it legislatively and get
it done within 6 months, as I did in 1993. I know that was your
understanding.
When we got it cleared through Judiciary Committee, it was
your hope, was it not, that you wanted your bill to be passed
as a freestanding bill in October in the waning days of the
105th, or were you looking for it to be part of an omnibus
bill?
Ms. Jackson-Lee. I did file it as a freestanding bill, and
as I worked through the process, Mr. Stupak, and got the
support of Chairman McCullum and Chairman Hyde, I certainly
wanted to collaborate with the appropriate jurisdictional
committees, but I wanted it to be a freestanding bill.
Mr. Stupak. Do you know of any reason why or have you had
any objections from any pharmaceutical manufacturers, from
anyone who would object to either your bill, my bill or any of
these passing as a freestanding bill?
Ms. Jackson-Lee. I would think with the intent of
pharmaceuticals to do good that there would certainly seem no
reason why they would not want to see this bill passed inasmuch
as, and you are the experts, this would not preclude a
medicinal use if it could be determined.
We want to see if that is the case, but at this point I
cannot imagine why there would be opposition, and I would hope
there was not opposition.
Mr. Stupak. You have worked on this--and especially with
the tragic circumstances in your district, in your opinion,
what is more dangerous, the use of GHB and its analogs as a
tool to facilitate rape or the use of GHB as the party drug of
choice for young people?
Ms. Jackson-Lee. Well, you have me between a closed door
and a brick wall. I would simply say that we know that the GHB
in young people resulted in deaths. We know that the rape use
of it has resulted in immobilization of the victim, who then
cannot help law enforcement to even find the perpetrator.
Death obviously will take the lead, but as a woman let me
tell you that I have experienced or seen victims and heard
stories from victims as we did our research, and it is an
enormous tragedy on all counts.
Forgive me for not trying to choose, but I think it is a
tragedy. Maybe you were giving me the rhetorical question to
say it is a dangerous drug that should be made criminal.
May I just add my appreciation to my counsel, who did not
have to sit here, but my staff person, Leon Buck, for the work
that he and our staff did on this particular matter.
Mr. Stupak. Leon does a good job, and I think he would
agree with you that both are equally dangerous facets of GHB.
Ms. Jackson-Lee. Absolutely.
Mr. Stupak. Let me ask you one more. I understand that your
bill, the Hillary J. Farais Date Rape Prevention Act, as it
currently reads asks that GHB to be placed on Schedule I of the
Controlled Substances Act.
Are you open to other solutions that would provide law
enforcement with additional tools for fighting the illicit use
of this drug?
Ms. Jackson-Lee. I think there is a great opportunity, Mr.
Stupak, for us to work together, and, yes, I am.
The only point that I would like to emphasize is the
consideration of the criminal penalty of 20 years or some
compromise thereof, but as well that we have an educational and
prevention piece in it because I really want to have young
people be aware themselves of the danger of the utilization of
these kinds of drugs.
Mr. Stupak. In fact, I believe both your bill and my bill
ask the Attorney General to put forth some education process
throughout the country as to the dangers of GHB and Ketamine--
--
Ms. Jackson-Lee. Absolutely.
Mr. Stupak. [continuing] and the precursor.
If we place GHB on Schedule III, but if we put the
penalties for Schedule I, which is I think $250,000 and 20
years----
Ms. Jackson-Lee. Yes.
Mr. Stupak. [continuing] you have no objection with that?
Ms. Jackson-Lee. We can work together, yes. Thank you.
Mr. Stupak. Thank you, Mr. Chairman, and I would yield back
my time.
Mr. Upton. The gentleman from Virginia, Mr. Bliley?
Mr. Bliley. I just have one question. My mind sometimes
gets rusty. Did you not call me and ask me to allow your bill
to be put on the omnibus bill at the end of the session?
Ms. Jackson-Lee. I called and indicated that I had a
freestanding bill and whatever the procedures might be to help
get it in these last moments.
My original request was a suspension bill, and staff
instructed and staff was working on other aspects and so
whatever they may have guided us to do, if it was possible,
that may have been the case, but my bill was a freestanding
bill that I asked to get on the suspension document at that
time, Mr. Chairman.
Mr. Bliley. Thank you.
Mr. Upton. Mr. Klink, do you have questions?
Mr. Klink. Yes, I sure do. Your testimony, I am intrigued
by it, and I just have to laud you for moving forward with your
bill.
I have to tell you. As the father of an 11-year-old
daughter, and not only your testimony, but I have read the
testimony of the other witnesses we are about to hear. I am
going to tell you something. We have to do something.
Mr. Chairman, I thank you for holding this hearing. This
action must be taken as immediate as we can take it. I just
really think that the kind of protections that we have the
ability to offer are certainly deserving by the young women of
this country and by their parents that will need the peace of
mind when they start to understand that these kinds of things
are happening.
I have to ask you, though. Are the punitive aspects of this
bill, do you think, enough that will stop the misuse of GHB?
Ms. Jackson-Lee. I think that if we utilize the 20 years'
penalty that is associated with Schedule I and the fine that is
associated that we will have a sufficient deterrent, along
with, ranking member Klink, the idea of the preventative and
educational aspects.
That is extremely important, and so I want to be very sure
that we have a combination, the criminal penalties that are
strong enough and the educational aspects.
Mr. Klink. We have to realize up front, though, that Orphan
Drug is telling us there are legitimate uses for GHB; for
example, the treatment of narcolepsy. Are you sensitive to that
use, and how would you deal with that?
Ms. Jackson-Lee. I am sensitive to the representation made
by Orphan Drugs, and I am sensitive to those who suffer from
that disease.
I believe that we will be able to have provisions that
would acknowledge the medicinal use of that drug and have this
defined in illicit use, possession and selling or utilization
of, and we separate it from the legal use of it.
I mean, we have a variety of drugs that fall in that
category that have medicinal purposes, and yet their illicit
use have a penalty at that level.
Mr. Klink. I do not want to speak for Orphan Drug, but I
think it is counsel's understanding that they are willing to
support Schedule III with very tough penalties, and I think
there are some other things that we might want to be able to
work some of this, I think.
Are there any other steps that might be taken to combat the
dangers of GHB?
Ms. Jackson-Lee. Absolutely. We must wage a massive
educational campaign because, as I said earlier, GHB by
teenagers--and who wants to speak for teenagers?--is a fun
drug, if you will, made in bathtubs, made for rave parties.
I do not think the point has gotten out how devastating and
deadly--just think of the examples. I think the chairman gave
his example of the victims in his community. These youngsters
have this drug the night before, and they are gone the next
morning.
There seems to be no way, because it attacks the central
nervous system, of getting them in there and bringing them
back, if you will, or using emergency medical devices because
it has no odor, it has no telltale immediate signs, and so you
cannot rush immediately to the hospital. They go home, and
tragically the next morning or maybe hours later they have
died.
I think that is the tragedy of what we are here. It is
extremely dangerous.
Mr. Klink. Have you been contacted by others besides the
Farais family who have had to deal with tragedies like this
involving GHB?
Ms. Jackson-Lee. In working with Officer Porrata, I know
that there have been occasions in California. There have been
incidents in Florida. Chairman McCullum is aware of them.
So, yes, we are aware of incidents of death that have
occurred because of the utilization of GHB and the
immobilization of those rape victims I think as well.
Mr. Klink. Again, when you read the stories that we are
going to hear today, just reading the testimony I cannot
imagine what it is going to be like to hear from these victims
and the parents of these victims who have gone through this
unbelievable experience.
I will tell you, Congresswoman Jackson-Lee, as I said, as a
father of a daughter that is about to enter that dating age, I
am pleased to work with you, Mr. Stupak, Chairman Upton, and
anyone else. We have to act very quickly. We cannot let this
threat out there in the public another day than is necessary.
I said in my opening statement and I realize our friends at
the FDA have limits because they have to go through procedures.
Congress has the ability to act, and I think with what Chairman
Upton has scheduled here today, with your help and guidance and
that of Congressman Stupak we can move very quickly and protect
the children of this country and also give the parents some
peace of mind that they deserve.
Ms. Jackson-Lee. Thank you very much, Mr. Ranking Member.
Mr. Upton. Mr. Whitfield, do you have any questions?
Mr. Whitfield. Thank you, Mr. Chairman.
Representative Lee, are you aware of any jurisdictions in
the U.S. today where it would be illegal to possess GHB?
Ms. Jackson-Lee. Pennsylvania and California. I am sorry. I
had to be refreshed.
Mr. Whitfield. Well, I did not have any idea, so I am glad
you did.
Ms. Jackson-Lee. We had all of this piled-up information. I
wanted to be accurate.
Mr. Whitfield. So in Pennsylvania and California, those are
the only two States in which it is illegal to possess GHB?
Ms. Jackson-Lee. That is why I think the congressmen and
myself have recognized this as a national issue deserving of
legislative attention.
Mr. Whitfield. So the only other way that someone that used
GHB illegally could be prosecuted criminally today would be if
the victim died or suffered some sort of permanent injury or
would be subject to a civil action? That would be the only----
Ms. Jackson-Lee. That is correct, or in an instance in our
State, in Texas, of course, there would be State criminal laws,
of course, causing the death of another.
Mr. Whitfield. Right.
Ms. Jackson-Lee. As to how that would be determined, it
could be manslaughter, et cetera, et cetera. You would be
subject to that, but it would never end the dissemination and
the making thereof of that drug and selling it for that
purpose.
Mr. Whitfield. So in 48 States, there is just nothing out
there?
Ms. Jackson-Lee. Nothing there, Congressman.
Mr. Whitfield. You and Mr. Stupak had a conversation about
Schedule I and Schedule III. Schedule I has a more severe
criminal penalty, I guess you said up to 20 years.
Ms. Jackson-Lee. Yes.
Mr. Whitfield. Is that correct?
Ms. Jackson-Lee. And $250,000 in fines, I believe.
Mr. Whitfield. I do not want to speak for Mr. Stupak, but
he seemed to be talking about Schedule III. What is the penalty
on Schedule III?
Ms. Jackson-Lee. Mr. Stupak?
We are now working. As he gets his answer, I will say to
you that I think in that instance that minimally at best, but
we are working in collaboration with Mr. Stupak to see how we
could combine the criminal penalties. That is the key for
getting the message out that we are serious.
I know that the criminal penalties for Schedule III did
not, in my opinion, fit the level of the crime.
Mr. Whitfield. Is there any difference?
Mr. Stupak. If the gentleman would yield? While we may
schedule it as Schedule III, we want the penalties as Schedule
I.
Mr. Whitfield. Okay.
Mr. Stupak. We had done that with Hipynol, which was
another one we did earlier, so we are following that same track
because the criminal intent here is so heinous when you can put
a person unconscious so they cannot help in the rape case, or
just by the use of it, as in this case here, people die.
While it may be scheduled under III because of the chemical
make-up, we want the penalties to be criminal penalties under
Schedule I, the maximum.
Mr. Whitfield. You would prefer that it be scheduled as
III, but have the penalties as I? Is that correct?
Mr. Stupak. Correct. Correct.
Mr. Whitfield. Is that----
Mr. Stupak. Because of the legitimate uses involved in
these drugs.
Mr. Whitfield. Okay.
Mr. Stupak. There are legitimate uses. It is when it is
used illegally or concocted illegally that we have the problem.
Mr. Whitfield. Okay. So, Representative Lee, you would not
object to that in scheduling it as a III and penalty as a
Schedule I?
Ms. Jackson-Lee. No. I am very happy to work with
Congressman Stupak on that collaboration.
Mr. Whitfield. Now, are you aware of any funds that would
be available at HHS or the Department of Justice or FDA or Drug
Enforcement Agency that could be used to educate young people
today about this problem?
Ms. Jackson-Lee. When we first looked at this question, we
looked to the Department of Justice, who indicated, or at least
let me not represent their indication, but that there would be
a revenue stream within the Justice Department for educational
and preventative information disseminated that would already be
included in their existing appropriations.
Let me not conclude or at least foreclose the need for
targeted funds for this legislation on the educational aspect.
Mr. Whitfield. Are you aware which particular program the
funds are already available at Justice for this purpose?
Ms. Jackson-Lee. I think they would come, and let me not
mis-speak, maybe under the community relations aspects, which
is an outreach program which might be helpful.
Mr. Whitfield. Okay. Now, I know you have been in the
forefront on this issue.
Thank you, Mr. Chairman.
Mr. Upton. Ms. DeGette?
Ms. DeGette. Chairman, I think Ms. Jackson-Lee has made a
compelling case, and so I will let her off of at least my hot
seat.
Thank you. I have no questions.
Mr. Upton. Okay. The gentlelady from Missouri?
Ms. McCarthy. Thank you, Mr. Chairman, for calling this
hearing.
Thank you, Representative, for coming forward with
testimony. I look forward to working with you toward successful
completion of legislation.
I am anxious to hear from the law enforcement panelists who
will follow you so that I can better understand while we do
change the schedule and the penalties how out in the States we
will actually enforce this new law so that it is more than just
merely a national intention and a Federal initiative, but
within our local law enforcement agencies and within our State
government we can make sure that your intentions are carried
out.
Thank you, Mr. Chairman.
Mr. Upton. Thank you.
The gentleman from Texas?
Mr. Green. Thank you, Mr. Chairman, and I again will not
belabor it because we have a long number of panelists.
I would like to congratulate my colleague from Houston. It
is my impression in Texas the State law is possession of GHB is
a Class A misdemeanor. Is that correct?
Ms. Jackson-Lee. It has that level. It is not a felony,
which is what we are trying to do.
Mr. Green. But selling it obviously is a State jail felony
time.
I agree that we need to do something on a national basis,
and so, Mr. Chairman, with that I will yield back my time so we
can go on, but congratulations.
[The prepared statement of Hon. Gene Green follows:]
Prepared Statement of Gene Green, a Representative in Congress from the
State of Texas
Thank you, Mr. Chairman, for holding this hearing. We must never
let down our guard in the fight against drug abuse.
Mr. Chairman, we are here today to talk about drugs that are being
horribly misused, these so-called ``date rape'' drugs. While none of
these drugs should be easily available, I think that Congress needs to
act to insure that our young people do not have access to these
dangerous substances.
In my hometown of Houston alone, there have been numerous cases of
young people becoming ill or dying from the abuse of one of the most
popular of these drugs, GHB.
In late 1996, a young woman from the Houston area, Hillory Farias,
died after someone laced her drink with a lethal quantity of GHB.
GHB, which is an unapproved drug, is currently under investigation
as a treatment for narcolepsy. A number of states have already
scheduled this drug. Currently, the Federal Drug Administration (FDA)
has GHB under consideration for scheduling and the Violence Against
Women Act, which I am a cosponsor of, would make this a Schedule I
drug.
More recently, the FDA has acted to remove GBL, a chemical
``cousin'' to GHB, from the shelves of gyms and health food stores,
where it was being sold as a nutritional supplement.
GBL is an organic solvent used in, among other things, paint
thinner. However, it was easily transformed through simple chemical
reactions to GHB.
Mr. Chairman, the FDA has been reviewing scheduling these drugs. I
would like to commend them for being proactive in addressing the
dangers of these and other drugs.
This Committee, though, has questions to answer. Where the FDA is
deliberate, and rightfully so, we have the power to act quickly,
swiftly and decisively on these issues.
In our first panel, we will hear from Ms. Jackson-Lee, my colleague
and friend from Houston. In 1997 and again this year, she has
introduced legislation that would make GHB and other ``date rape''
drugs, like ketamine, schedule I or II drugs.
Previously, her legislation, for whatever reason, died after being
referred to the Commerce Committee. No action was taken on her bill.
This is after the Judiciary Committee waived a full hearing for her
bill, based on its bipartisan support.
Also, my colleague and friend on this Committee, Mr. Stupak of
Michigan, introduced similar legislation, which would have made these
drugs schedule III drugs. His legislation, after being referred to the
Commerce Committee, died without action at either the Subcommittee or
full Committee level.
Mr. Chairman, if these drugs are as dangerous as I think everyone
here knows them to be, then why should we wait? Why has our Committee
not scheduled these bills for hearings or markups? Why have we not
moved these bills to be voted on by the House?
We know that these drugs are powerful sedatives with dangerous side
effects. Let's get together and put aside our differences to protect
America's youth.
We need to make it as difficult as possible for our children to get
their hands on these drugs. Sitting around and doing nothing is
irresponsible and dangerous to our children.
Ms. Jackson-Lee. Thank you very much, Mr. Green.
Mr. Upton. The gentleman from Tennessee, Mr. Bryant?
Mr. Bryant. I thank the chairman, and I would say that it
is disappointing having to be here to hear this testimony and
the fact that this is a subject that we do need to act on and
probably should have acted some time ago.
I know all sides on this issue--it is certainly not a
partisan one--agree that this is a serious problem, and we have
attempted to address portions of this previously, but there is
I guess a continuing problem that we are going to hear more
about today. I look forward to doing that.
I simply want to close my remarks by thanking my colleague
from Texas for the outstanding work that she is doing in this,
and also I would add a compliment to her staff. Having lived
next door to them for 4 years now, going on our fifth year, we
have a great relationship.
Ms. Jackson-Lee. Thank you.
Mr. Bryant. Again, I appreciate very much your efforts, as
well as your office. Thank you.
Ms. Jackson-Lee. Thank you very much. Thank you for your
help.
Mr. Upton. The gentleman from Ohio, Mr. Strickland? Do you
have questions for----
Mr. Strickland. No opening statement. Thank you.
Mr. Upton. Do you have questions? Your opening statement,
if you want, will be----
Mr. Strickland. No questions.
Mr. Upton. Okay. Ms. Jackson-Lee, thank you for coming. We
appreciated your testimony and your answers.
Ms. Jackson-Lee. Thank you very much, Mr. Chairman.
Mr. Upton. We look forward to working with you.
Ms. Jackson-Lee. Mr. Chairman, let me thank you for this
hearing.
My legal mind wants to just conclude by simply saying that
this bill, we hope, will go forward as a freestanding bill as I
wanted in the last Congress, and any questions to suggest its
inclusion in omnibus, let me make sure that we clarify and say
that if we were advised by staff to do anything that might have
added it to that at that point that might have been the action,
but it did not occur so I want to be very clear that we did not
have it in that legislation, and we hope that we will move
forward in a freestanding bill this session. I want to clarify.
Mr. Upton. Thank you. Thank you.
Ms. Jackson-Lee. Thank you very much.
Mr. Upton. Okay. We are ready for Panel 2.
You are excused.
Ms. Jackson-Lee. Thank you.
Mr. Upton. The next panel will be Dr. Felix Adatsi from
Michigan State Police; Ms. Jo Ellen Dyer, Assistant Clinical
Professor of Pharmacy at the University of California-San
Francisco; Lieutenant Paul Bane from the Drug Enforcement
Command from the Maryland State Police; Ms. Denise Snyder from
the Rape Crisis Center here in Washington, D.C.; Ms. Trinka
Porrata from Pasadena, California; and Sergeant Mark
Faistenhammer from the Grosse Ile Police Department.
We are hoping that Mrs. Lugene Pruett and her daughter,
Candace, from Virginia will be here as well.
Male Voice. They are here.
Mr. Upton. They are here. Okay. Good. Terrific.
If all of the witnesses would take an appropriate seat at
the table? If you were here at the beginning, you heard me tell
Ms. Jackson-Lee that the common practice in this subcommittee
historically has been to take your testimony under oath. Do any
of you have an objection to that?
[No response.]
Mr. Upton. We also have the practice if you would like to
have counsel, which you need to let us know about in advance.
Anyone have a problem not having counsel?
[No response.]
Mr. Upton. Okay. If you would stand with me and raise your
right hand?
[Witnesses sworn.]
Mr. Upton. All right. Ms. Pruett, we will start with you.
By the way, for all the witnesses I had the luxury of
looking through some of your testimony last night because you
complied with our committee rules. Your testimony will be made
entirely a part of the record.
We would like you to limit your remarks to 5 minutes. I
know for some of you you will either have to read very, very
fast, or you will have to summarize it in quite a fashion.
We appreciate your testimony, but we would like to stick to
the 5 minute rule.
Ms. Pruett, thank you for coming.
TESTIMONY OF CANDACE PRUETT, ACCOMPANIED BY LUGENE PRUETT,
COMMONWEALTH OF VIRGINIA; G. MARK FAISTENHAMMER, DETECTIVE,
GROSSE ILE POLICE DEPARTMENT; TRINKA D. PORRATA, DESIGNER DRUG
CONSULTANT; JO ELLEN DYER, ASSISTANT CLINICAL PROFESSOR OF
PHARMACY, UNIVERSITY OF CALIFORNIA AT SAN FRANCISCO BAY AREA
REGIONAL POISON CONTROL CENTER; PAUL BANE, DRUG ENFORCEMENT
COMMAND, MARYLAND STATE POLICE; FELIX ADATSI, TOXICOLOGY UNIT,
MICHIGAN STATE POLICE; AND DENISE SNYDER, DC RAPE CRISIS CENTER
Ms. Pruett. Thank you, Mr. Chairman and members of the
committee.
Mr. Upton. If you would not mind, all the witnesses,
putting the mike fairly close to you? That would be terrific.
Thank you.
Ms. Pruett. Thank you for inviting me to appear before you
today. My name is Candace Pruett, and I am an 18-year- old
senior in high school.
Three years ago, I was raped after someone gave me a soft
drink laced with Rohypnol, which left me unconscious for
several hours. I am appearing here today to warn other
potential victims about the dangers of date rape drugs and how
they can be misused. I hope that by telling my story I can help
prevent other unsuspecting victims from being assaulted like I
was.
One of the most difficult things I had to cope with after I
was raped was not knowing what happened to me that night. One
of the symptoms associated with the so-called date rape drugs
is that you remember very little, if anything, after being
given the drug.
Afterwards, I did not know what happened to me. I did not
know what I had been given, that I had been given a drug or
that I had gone into a coma and could have died. I did not
remember being raped, nor did I even know who raped me. The
only things that I knew were that something was very wrong, and
I wanted to go home. I do know these questions should never
have to be faced by any 15-year-old girl.
Luckily, my parents had notified the police, who found me
the next morning. I was taken to a hospital where they were
able to perform a test which revealed that I had been given
Rohypnol.
Additional tests indicated that I had been raped by a 19-
year-old man while I was unconscious. The police were able to
apprehend this person and later bring him to trial, but it was
not until he made two separate attempts, one fleeing the State
and one fleeing the country, to avoid his prosecution.
The most frustrating part of the trial was that I could not
remember what he had done to me. I wanted to be able to tell
the Judge and jury what happened that night, but I could not
because of the drug that was given to me.
The forensic evidence, including the tests the police had
given me, showed that I had been given Rohypnol and that
someone had raped me. The drug, unfortunately, had robbed me of
my memories and what happened that night. What he did to me
also robbed me of my childhood. Going through the trial took
away my innocence and forced me to become a grown up.
I hope that by appearing today, I can let other people know
about the danger that exists because of the sick people who use
these drugs to assault unsuspecting victims. I also want to
reassure other girls who may have been drugged and assaulted to
immediately get help.
An entire network of people, including counselors, police
and prosecutors helped me during the trial. By seeking such
assistance, other victims can get the help they need and
hopefully work to put their rapists in jail.
I want to thank the chairman for giving me the chance to
tell my story today and hope that the committee can find some
way to prevent what happened to me from ever happening again.
Thank you.
[The prepared statement of Candace Pruett follows:]
Prepared Statement of Candace Pruett
Mr. Chairman and Members of the Committee, thank you for inviting
me to appear before you today. My name is Candace Pruett and I am an
eighteen year old high school senior. Three years ago, I was raped
after someone gave me a soft drink laced with Rohypnol, which left me
unconscious for several hours. I am appearing here today to warn other
potential victims about the dangers of date rape drugs and how they can
be misused. I hope that by telling my story, I can help prevent other
unsuspecting victims from being assaulted like I was.
One of the most difficult things I had to cope with after I was
raped was my not knowing what had happened to me that night. One of the
symptoms associated with the so-called date rape drugs is that you
remember very little if anything after being given the drug. I did not
know that I had been given a drug, or that I could have gone into a
coma and died. I did not remember being raped, nor did I even know who
raped me. The only things that I knew were that something was very
wrong and that I wanted to go home. I do know that these questions
should never have to be faced by any fifteen year old girl.
Luckily, my parents had notified the police, who found me the next
morning. I was then taken to a hospital where they were then able to
perform a test which revealed that I had been given Rohypnol.
Additional tests indicated that I had been raped by a nineteen year old
man while I was unconscious. The police were able to apprehend this
person, and later bring him to trial, but not until after he made two
separate attempts to flee the state to avoid prosecution, once getting
as far as London, England before being brought back to stand trial.
The most frustrating part of the trial was that I could not
remember what he had done to me. I wanted to be able to tell the judge
and jury what happened that night, but I could not because of the drug
that I had been given. The forensic evidence, including the tests that
the police gave me, showed that I had been given Rohypnol, and that
someone had raped me. One of the scariest things about date rape drugs
is that they are absorbed very quickly by your body. If a test for the
drug is not performed right away, it may only detect very small traces
of the drug or it may not even show up at all. Another problem is that
not all laboratories even know how to test for date rape drugs. Before
I went to the hospital that morning, my mother had called several labs,
but could not find any labs who were willing or knew how to test for
date rape drugs.
The drug I was given unfortunately had robbed me of my memories of
what happened that night. What my attacker did to me also robbed me of
my childhood. Going through that trial took away my innocence and
forced me to become a grown-up.
I hope that by appearing today, I can let other people know about
the danger that exists because of the sick people who use these drugs
to assault unsuspecting victims. I also want to reassure other girls
who may have been drugged and assaulted to immediately get help. An
entire network of people, including counselors, police and prosecutors
helped me during the trial. By seeking such assistance, other victims
can get the help they need and hopefully work to put their rapists in
jail.
I want to thank the chairman for giving me the chance to tell my
story today and hope that he and the Committee can find some way to
prevent what happened to me from ever happening again.
Mr. Upton. Thank you very much.
Sergeant Faistenhammer?
TESTIMONY OF G. MARK FAISTENHAMMER
Mr. Faistenhammer. Good morning. I am a Detective/Sergeant
with the Grosse Ile Police Department assigned to a Michigan
State Police managed drug unit known as DRANO.
DRANO is a consortium which is made up of 19 member
communities, and we police south of Detroit, Michigan. The unit
is administered and managed by the Michigan State Police. My
role there is an assistant crew leader and an investigator of
controlled substance distribution in the metro Detroit area.
During the past 2 years, the unit itself has noted an
increase in the illegal distribution of GHB and GBL, a
component of GHB. We often refer to it out on the street as
scoop. Unit members are aware and have assisted in several
investigations in the area 19 member departments, one of them
being Brownstown Police Department, where they have had in the
last year and a half 13 complaints of persons being scooped out
of bars; that is, given GHB without their knowledge in the bar,
someone pouring it in their drink, either by rescue runs or
complaints the following morning.
One of the people involved was a 15-year-old who was given
GHB without her knowledge in May, 1997. Sex acts were done to
her in an unconscious state, and the offender has been
successfully prosecuted in Michigan and is in jail currently.
The Riverview Police Department, another member of our
consortium, has reported three confirmed suspicious deaths from
GHB. The persons involved were body builders. Laying on the
floor next to them were bottles of clear liquid. At the time,
neither the officers involved in the case nor did the Wayne
County Prosecutor's Office know to even look at GHB as the
culprit. Although it is not the listed cause of death,
information that the DRANO unit has been able to develop makes
it more than just the suspected culprit in the cases.
Cases that officers have investigated have been hampered by
the fact that the body actually produces GHB; that in our
bodies GHB is contained in there at all times. Additionally, it
has been reported that GHB dissipates from the body within 24
hours, making it tough to find on autopsy.
At the same time, the DRANO unit has numerous cases that
are open, but one of which currently has 12 suspects that just
in our 19 member community has been mixing and distributing GHB
in the area bars.
Investigations from Woodhaven Police Department, as well as
Gibraltar and Southgate Police Department, all describe deaths,
people being scooped out of bars. Again, I refer to scoop as
the act of placing it without your knowledge.
The Michigan State Police DRANO unit, through
investigations, believes that GHB is a drug of abuse that we
need your assistance on. We have been finding it in our gyms.
Body builders utilize scoop as a fat-burning process, as well
as a method for getting high without the calories of alcohol.
We also find it inside the dancers at many area bars who
use it because they in turn can get high. They will place one
capful of this clear liquid, and they report that it equals
approximately 12 beers.
Users report that they become extremely addictive to the
drug. We have arrested people who we have had a great deal of
problems in incarceration in that they have had to be woken up
and actually needed to take GHB four or 5 hours into their
sleep. They report to being addicted to GHB 24 hours a day.
The biggest problem for us at the Michigan State Police is
that there are no test kits available. Since it is not an
illegal drug, companies are not pursuing the test kit. When we
run into it on the street, we cannot develop probable cause.
There is no immediate way to test for GHB in the containers
that we are running into.
When I say just GHB, I also mean GBL. In addition, officers
have been buying large quantities of GBL. We have learned that
GBL is manufactured by the body into GHB. GBL is a component in
making GHB, so what has been occurring with us is that we have
a group of attorneys in the metro Detroit downriver area who
have been advising their clients to not sell GHB, but to
distribute GBL and a person's body will make it for you, so the
analog statute is very important. We fell a bit short in
Michigan State law on that.
As a member of the Grosse Ile Police Department, we have
been working in conjunction with the Wayne County Prosecutor's
Office in the investigation of the death of a girl who came to
Grosse Ile in the middle of the night and with her friends was
also scooped out. This girl recently died in January of this
year.
[The prepared statement Sergeant G. Mark Faistenhammer
follows:]
Prepared Statement of G. Mark Faistenhammer, Detective Sergeant, Grosse
Ile Police Department, Michigan State Police, S.E.C.I.D. DRANO Unit
I am a D/Sgt. from the Grosse Ile Police Dept., assigned to the
Michigan State Police, Downriver Area Narcotics Organization (DRANO).
DRANO is a consortium made up of 19 member communities, which is
located south of Detroit, MI. The unit is administered and managed by
the Michigan State Police. My role at DRANO is that of Assistant Crew
Leader and an investigator of controlled substance use and distribution
in the metro Detroit area. During the past two years the DRANO unit has
noted an increase in illegal use and distribution of GHB which is
BUTYROLACTONE (GBL) plus SODIUM HYDROXIDE equals GHB, with the street
name of ``scoop''. Unit members are aware and have assisted in
investigations with several members of other departments to include the
Brownstown Twp. Police Dept. who, through investigations, have at least
13 ``scooped'' victims in the past one and a half years. ``Scooped'' is
what is referred to as the placing of GHB in someone's drink without
their knowledge. Example: If you were at a bar and someone did place
GHB in your drink, people on the street refer to you as being
``scooped''. One of Brownstown Twp. cases involved a 15 year old girl
who was given GHB without her knowledge and therefore was ``scooped''
in May 1997, and sex acts were done to her in an unconscious state. The
offender has been prosecuted and is currently in jail.
The Riverview Police Dept., an additional member of the downriver
community, reports at least 3 confirmed suspicious deaths where GHB is
the suspected culprit. The persons involved were body builders, and
lying on the floor next to them was a bottle with a clear liquid
inside. At that time, neither officers knew about GHB nor did the Wayne
County Medical Examiner. The cases were not noted GHB deaths, however
information received by DRANO officers makes GHB more than the
suspected culprit.
Cases that this officer has investigated have been hampered by the
fact that the body produces GHB, not only after death, but contains
some GHB in it at all times. Additionally, it is reported that GHB will
dissipate from the body within 24 hours, making it impossible to find
during an autopsy. At this time, in just one of the DRANO units open
cases, there are at least 12 suspects that are responsible for the
transportation, mixing and distribution of GHB into our area.
Investigators from the Woodhaven Police Dept., another downriver
community, reports five unexplained deaths. In the past year at least
two juveniles have been ``scooped'' in Woodhaven and admitted to the
hospital for an overdose. Gibraltar Police Dept. and Southgate Police
Dept. also reports incidents of ``scoop'' in their area.
The Michigan State Police DRANO Unit, through their investigations,
have learned that GHB is a drug of abuse, which has been on an increase
in the area gyms. Body builders utilize ``scoop'' to assist them in
their fat burning process, as well as a method of getting high without
adding the calories of alcohol. Body builders seem to equate one pop
bottle cap full of GHB equaling the high of approximately 12 beers.
DRANO officers have located GHB mostly in pop bottles, however numerous
water bottles and containers have been discovered. This same formula
has been utilized by dancers in adult bars. The dancers abuse GHB
because it gives them the alcohol high without the calories. This
officer has been involved in investigations where persons utilizing the
GHB have been severely addicted to the drug. Users report that they
will take GHB, go to sleep at night, and approximately four to five
hours later wake up with a severe need to utilize GHB again and remain
on the drug throughout the day and night (24 hours a day). In spite of
the fact that these abusers have been in drug rehabilitation, they
continue to come out and go right back to utilizing GHB.
One of the biggest problems for the Michigan State Police DRANO
Unit has been the fact that there are no test kits available and that
the Michigan State Police lab is having problems with the analysis of
GHB. Most any material the lab would use to break down and test the GHB
also manufacturers it. In addition, officers on the street brought in
numerous bottles and containers from inside vehicles, which have a
possible odor of being GHB; but have no method of testing the liquid on
the street. Therefore, we have established a great need to develop a
field test kit. DRANO officers have also run into a major problem in
that GHB components are legal. An example would be GBL, which is one of
the major components needed to make GHB. It has been learned that if
GBL, is consumed by itself the body will then produce GHB and the same
high will be accomplished. Officers have seized multiple gallons of GBL
and cases cannot be brought against the culprits because it is not GHB,
but in fact GBL. DRANO officers are finding abuse of GHB and GBL in
various locations such as the local bars, adult dancing bars, gyms,
high schools, therefore by persons from all walks of life. Information
from confidential sources, as well as defendants themselves, have
stated that lawyers are advising persons engaged in sales of GHB to
only deal in GBL, a GHB component. The attorneys are advising their
clients that there is no federal law prohibiting GBL and that state law
in the State of Michigan does not cover GBL only GHB. Officers in the
DRANO unit have several cases where only GBL has been acquired from the
suspects. I have been a party to an investigation assisting the Grosse
Ile Police Dept. in an incident where juvenile girls were ``scooped''
or possibly given GBL without their knowledge. The suspects in this
particular case admit that they deliberately gave the girls GBL,
knowing that their bodies would convert it into GHB and did so without
the knowledge or consent of the girls. Both of the juvenile girls given
the drug were admitted to the hospital in an unconscious state. The
outcome was one of the girls was eventually pronounced dead at the
hospital and the second recovered from a severe overdose. The Grosse
Ile Police Dept., working with the Wayne County Prosecutor's Office and
the Michigan State Police, should be acquiring warrants within a couple
of days but word from the prosecutor's office is that it will be a
death by poisoning charge as opposed to a charge involving GHB or GBL.
In the prospective of officers investigating these types of cases
at the MSP DRANO unit, the inadequate laws, as well as the nature of
GHB interacting with the body, makes them difficult if not impossible
to prove. Our crime labs are having a difficult time analyzing GHB, the
fact being if you take GBL and place it in the body, the body itself
will manufacture GHB and the person will get high anyway. The fact that
there are no test kits available for officers on the street who may
encounter GHB or GBL, and that the drug dissipates in the body, blood,
or urine samples within 24 hours whether the subject is alive or
deceased, makes the investigator's task to be more than just
cumbersome. Officers can only rely on assistance from the FDA as
opposed to being able to call the Drug Enforcement Administration, FBI,
or United States Customs and get the assistance needed from agencies
set up to deal with illicit drugs.
Mr. Upton. Thank you.
Folks here in the room know the buzzer has sounded, which
means we have a vote in progress. Mr. Burr has gone over to
vote. He will relieve me soon, but we will continue with the
testimony since the witnesses have started.
Ms. Porrata, you are recognized for 5 minutes.
TESTIMONY OF TRINKA D. PORRATA
Ms. Porrata. Thank you. I have waited a long time to be
here for this day. I normally teach an 8-hour class, so I will
try to condense it.
I brought these because I want you to see just how easy it
is to hide GHB. This is all that a rapist needs to commit a
rape with GHB; nothing more than a little eyedropper full. The
guy who just got 77 years in California for rape with GHB
started his career with just an eyedropper in his pocket.
We see it now in little Bianca bottles, food coloring and
vanilla bottles. They are nice, flat bottles. They fit in a
man's pocket nice and easy when he goes to the club. A
videotape of suspects in Hawaii were using food coloring
bottles for that purpose.
Any container that will hold a liquid. It seems like an
empty container. No. He just drank the GHB out of it. Mouth
wash bottles, water bottles. I commend the officers who found
this one. It was a woman's hair spray bottle, purse size, full
of GHB, taken into a club, and we have seen it in kids'
bubbles.
There is not any container that is not fair game. It is a
clear liquid. It can be colored to look like the mouth wash or
the Gatorade bottle that it is in. It does not matter. It is
just that easy to hide, and law enforcement is missing it.
You have absolutely no clue how big this problem is. The
rape statistics are minute compared to what really is going on.
For every rape victim out there, there are hundreds of
overdoses that were caused by voluntary ingestion. There are
dozens and dozens of kids deeply, deeply addicted to this drug.
It is much more harder to get off of than heroin.
I get e-mails from kids who say I shook heroin on my own. I
shook cocaine on my own. I shook nicotine. Why can't I get off
of GHB? It is that hard for them to get away from.
It is hard to believe that if your kid is running around,
if you have a 15-year-old son, a 25-year-old son. A 30 year
veteran of the Los Angeles Police Department, his son walked
around the house sipping from a water bottle. He thought it was
kind of odd that he sipped from it. You normally drink from a
water bottle. His son had a deep, deep, serious addiction to
GHB right in front of him, and he knew nothing about it until
he read my training bulletin.
The scope of this problem is humongous. If you really look
at it, it is far bigger than rape. Rape is a serious issue, but
we are missing the boat. This is a serious drunk driving issue.
We have had at least a couple of deaths from it. You have to
understand that for every death that occurs, there are more
that just were not caught by the coroner. For every drunk
driving case, there are hundreds more that were not caught.
In California, a young man made it two and a half times
through the criminal justice system without GHB surfacing. He
was convicted for drunk driving with actually a very low blood
alcohol, but his aggression was so intense that he did get
convicted. They thought it was alcohol only.
The second time he had a very low BA, and he got through as
a reckless driver because again a very low BA, a negative for
any other drugs in the standard drug screen, and yet the third
time when he killed somebody he got through the prelim as a
drunk driver only, alcohol only, but the word GHB came up
during the investigation, and we were able to get it tested and
determine that he was a chronic GHB user. We had testimony to
that effect. He pled guilty. He is doing 14 years in
California.
There are hundreds more cases like that out there, but the
officers did not notice the water bottle on the car seat or the
mouth wash bottle on the floor of the car. They would have no
way of knowing. The training is totally inadequate. Every
single place that I teach--every single place--within 2 weeks
they are arresting people for GHB.
I want to stress the biggest problem I have had in doing
the legislation in California and other States is the total
misunderstanding and confusion. This drug has no approved
medical use. There is no approved medical use for GHB.
Your action, if you put this in Schedule III, does not make
this drug available as a prescription drug. Orphan Medical
would like to get their foot in the door by you doing that, but
by making it Schedule III you are not approving this drug. The
FDA still has to do that.
The failure of the Federal Government to take action on
this drug has caused additional confusion in the States. The
States, too, when they look at this drug go whoa. We have this
drug company here telling us it is like a good drug, and they
have these people that want to come and take this drug.
That is not what determines what schedule you put it in. I
am personally bothered as an officer who just retired and as a
citizen that the drug scheduling concept is now being violated
based on what the drug companies want.
Rohypnol. There is no approved medical use for Rohypnol,
yet it is in Schedule IV. I plead with you to put these drugs
where they belong. These are unapproved drugs. There is no
medical use. If and when there is ever a medical approval, then
you can move them down.
[The prepared statement of Trinka D. Porrata follows:]
Prepared Statement of Trinka D. Porrata, Designer Drug Consultant
Law enforcement is literally drowning in the ``standard'' drugs of
abuse--cocaine, methamphetamine, heroin and marijuana. Law enforcement
is now only beginning to realize that we are far behind in accessing
the depth and breadth of the current drug problem. As a whole, law
enforcement has failed to notice that 13 of the top 20 drugs of abuse
are prescription medications. Very few agencies have any resources
assigned to pharmaceutical diversion issues. Meanwhile, street drug
``news'' (whether accurate or inaccurate) now travels as fast as the
click on an icon. Crime laboratory statistics re seizures of trendy
drugs like MDMA (Ecstasy), gamma hydroxy butyrate (GHB), ketamine
(Special K) and flunitrazepam (roofies or Rohypnol) are minute compared
to statistics for the old standard drugs. But, after 25 years as a
police officer, seven years as a narcotics officer and three years
fully immersed in the issues of these trendy drugs, it is my opinion
that those figures do not reflect reality. The trendy drugs have been
considered to be off in some small segment of society, such as the RAVE
crowd or the wildest and highest echelon of the Hollywood set, and thus
not a big issue.
But, while we weren't looking, those trendy drugs have become
mainstream. The truth is, the average police officer, the average
narcotics officer, knows very little about prescription drug abuse and
even less about violations by the doctors and pharmacists who knowingly
feed this market. The average police officer/narcotics officer knows
very little about ketamine, flunitrazepam, GHB and MDMA.
These now mainstream drugs circulate in subcultures and
environments where law enforcement either has limited contact or
doesn't expect to deal with drug abuse issues, such as: 1) in RAVE/Goth
gatherings, college/high school gatherings, on any beach, 2) in health
clubs/gyms and on the high school playing field and in after-game
activities of the athletes and cheerleaders, 3) now predominant in many
restaurants and clubs catering to 21-35 year olds with college degrees,
driving fancy cars, 4) in any stripper or exotic dance club, and 5) in
the hands of sexual predators.
None of these environments are the focus of narcotics enforcement
efforts. In fact, most agencies avoid RAVE gatherings like the plague
unless called in to handle the aftermath of civil disturbances or
medical emergencies.
These drugs are becoming more common in drunk driving and sexual
assault cases, though our standard drug screening does not include many
of them. Some present unique testing issues, yet we have not adequately
responded by modifying our testing and rape investigation protocols and
improving our testing capabilities.
One would expect the federal Food and Drug Administration (FDA) to
take the lead, providing prompt and accurate information regarding
existing and developing drugs and to be definitive as to current/
potential licit status of any drug and its abuse potential.
One would expect the Drug Enforcement Administration (DEA) to be
cutting edge on issues of illicit trafficking, manufacturing and abuse
as it develops. But in my experience, their roles have been quite
passive, not active. Thus, we are here today talking about drugs that
are in reality 25-30 years old and have all been abused to varying
degrees throughout that existence. GHB is perhaps the youngest in terms
of discovery by abusers, though it is now literally exploding around
the world.
Many people do not understand the difference between state and
federal laws; it is particularly confusing when it comes to drug
scheduling. Many do not understand how a drug can be scheduled in a
state, but not federally, and vice versa. There is a logical pattern
for how drugs are to be scheduled. This is defined by terms such as
``approved medical use'' and ``abuse risk.'' I don't see the term
``drug company's desires'' in the formula, though I have seen clearly
that their desires do drive much of what happens in recent drug
scheduling efforts.
In actuality, there have been several dedicated FDA and DEA agents,
chemists and doctors working on these specific drug issues. But, they
have not had full support from management and/or issues become lost in
the tangle of bureaucracy and politics.
ketamine
Ketamine clearly has legitimate medical uses and has endured in the
legitimate medical world far beyond PCP, its chemical cousin. But we
have known for decades that it has a high abuse factor, with flashbacks
worse than PCP. One year ago, while trying to upgrade mere possession
charges for ketamine in California, I was told that the volume of
legitimate medical use of ketamine had not changed significantly, but
manufacturing of ketamine was up 40 percent. If that is true, that
should be a dramatic indicator of the abuse level of ketamine in this
country at this moment. Yet ketamine is not federally scheduled. DEA
has someone ``tracking'' ketamine abuse, but it is a rather passive
role to date. I've personally seen nothing on this abuse issue actively
emanating from the FDA.
flunitrazepam
Flunitrazepam (Rohypnol, aka roofies) is already federally
scheduled (Schedule IV), and from a law enforcement viewpoint, I can
force myself to ``settle'' for that since at least something can be
done when this drug is encountered. But philosophically, it bothers me
because it violates the drug scheduling concept and is a clear case of
where big money has won, and the poor folks (victims and law
enforcement) have lost. Even the American medical community has no
interest in this drug. Flunitrazepam is a Schedule I drug by
definition. It is not approved for medical use in the United States and
has a very high abuse factor. There is really nothing this drug does
that other drugs don't do as well and with less side effects. In seems
from my exposure that much of the worldwide use of flunitrazepam is
abuse, especially by those addicted to other drugs who merely use it as
a facilitator (to extend their heroin) and/or as a transitional drug
(to cushion the crash from stimulant abuse). I'm not concerned that the
manufacturer doesn't want to give up this drug worldwide since it
generates more than $100 million per year for them. I'm not concerned
with their fears that Schedule I in the U.S. might cause a domino
effect and cause other countries to gradually drop it. So be it. The
money spent on flunitrazepam would most likely transfer to other
benzodiazepines. It is my personal opinion that flunitrazepam is
Schedule IV for purely political reasons.
gamma hydroxy butyrate (ghb)
Thirty years ago, a doctor researched GHB for a major drug company
and found that it caused virtually all lab animals to vomit and many to
convulse. Brain waves went into an epileptic seizure mode. That drug
company walked away from it, and that doctor predicted that GHB would
become a horrible drug of abuse. He is only surprised that it took so
long to happen. Ironically, he recently retired from the FDA, and yet
the FDA has not been a leader in the fight against GHB. In fact, once
DEA documents on GHB went to FDA (HHS) for review, it seemed to me that
time stood still. In the late 80's when GHB was being sold over the
counter at ``health food'' stores (a strange name for a place that
sells bizarre chemicals with little or no confirmation as to content or
actual efficacy) and overdoses became an issue, the FDA merely banned
GHB from OTC sales. It was not controlled. While the FDA criminal
investigators could make arrests for manufacturing and interstate
violations, DEA agents had no power and thus no interest in this drug.
A few federal manufacturing cases were indeed handled, albeit a very
long-term process. There are actually very few FDA criminal
investigators per area, making it difficult to engage in the full-scale
surveillance/investigation often needed on a criminal case. DEA agents
could not help them. Unless it was state controlled, most state/local
agencies might not help them either.
Overdoses continued to occur and in fact to start a significant
uphill trend in 1993, especially after highly publicized death of a
youth idol who MAY have ingested GHB, along with lethal doses of others
drugs. Still no control. Meanwhile, DEA has had drug diversion
professionals tracking GHB for years. One doctor was researching both
GHB and flunitrazepam. Sometime after June of 1996, it became
impossible for one person to track both, and a second doctor was
assigned to track GHB. Even with the all the material they amassed, DEA
formally took no aggressive action. While in California the Los Angeles
Police Department actively sought to initiate legislation, the first
federal legislation came not from initiation by DEA, but from
Congresswoman Sheila Jackson Lee, in response to the death of a 17 year
old in Texas.
In my travels, I realized that there was no reporting system in
place all this time for these drugs, especially GHB; therefore, there
are not accurate records of overdoses. There is no actual reporting
system for arrests or seizures or deaths. Statistics depend primarily
on word of mouth, by polling of agencies or other hit/miss methods. In
early 1997, DEA was saying there were six or seven GHB related deaths.
I felt strongly that this was a bizarre understatement, and the DEA
doctors agreed. Within a few months, the figure jumped to more than 20.
Many of those ``new'' deaths had already taken place; they just weren't
being ``reported'' to anyone. It became apparent that if someone simply
called every coroner in the United States, the figure would simply
continue to rise. That isn't even allowing for cases missed because the
vast majority of coroners and toxicologists had never heard of GHB.
Furthermore, that death list wasn't initially even acknowledged
publicly by the DEA. It was like an in-house secret.
Neither the FDA nor DEA has taken a formal leadership role in
developing testing skills and making them available to law enforcement,
toxicologists and coroners. Some federal employees taking an interest
in developing and sharing expertise seemed to be stifled by superiors.
Neither the DEA nor FDA speak openly to the news media, causing
more confusion and misinformation. On December 31, 1996, Los Angeles
experienced a night of horror, caused by 1,4 butanediol, an active
analog of GHB. A RAVE concert turned into a mini-riot after more than
50 people suffered medical problems after ingesting ``FX.'' Eight LAPD
vehicles suffered damage and a 17 year old had a heart attack. We were
baffled that FX contained no controlled substance and was negative for
GHB. We had no ability to test further; and the case was turned over to
the FDA. The news media wanted to help up with this, as they had been
doing with flunitrazepam the year before. The FDA simply refused to
release the test results. A private lab had also tested the product and
identified the GHB analog, 1,4 butanediol. But, the FDA continued to
refuse to assist the media. One local radio newsman, who had the
private lab's results, told me he was livid that FDA press relations
personnel (both in California and Washington) refused to even provide
him with basic information on 1,4 butanediol. He said he wasn't even
asking for them to confirm that this matched their test results.
Federal prosecution of the FX maker was very slow, resulting in minimal
publicity of the finale.
FDA agents in California who developed expertise in GHB seemed to
be discouraged from spending time on such cases. Keeping tabs on one
GHB trafficker who supplied GHB from Hollywood to the RAVE parties in
the California high desert where a 15-year-old died (January 1996) from
ingesting GHB, FDA agents were aware of ongoing purchases of jug after
jug of the precursor, gamma butyl lactone (GBL). It would be 1\1/2\
years before the blood of the dead 15 year old was tested for GHB and a
criminal investigation actually launched. Once the case actually got
underway, it has been handled aggressively and I understand is now
pending. It would be October of 1997 before other members of that
organization were arrested by the LAPD Clandestine Lab Squad in a
separate incident. By then, GHB was illegal in California, and the
Squad worked with the FDA agents to achieve a state-level case.
Approximately three gallons of GHB was seized. There have also been
nine and ten gallon seizures in California. Bear in mind, a 16 ounce
water bottle holds approximately 80 capfuls, each capful being a
``dose.''
It is imperative to note that placing GHB Schedule I will not
impact the orphan drug research underway for narcolepsy. If--and it is
a very big if--GHB is ever approved for any use, it can easily be
dropped to Schedule II at that time. I have interviewed narcolepsy
researchers and read the literature. It is my personal opinion that GHB
will never be approved for medical use. At best, it may be some distant
cousin, safer and longer acting, and it is probably years away. One
leading GHB/narcolepsy researcher apologized to me for a story aired on
national news in late 1996, calling GHB the wonder drug. He said he had
been interviewed for three hours and stressed repeatedly how dangerous
this drug is. He said he keeps only one day's supply in his clinic for
fear of diversion. He said that GHB was at least six to eight years
away from qualifying for Schedule II consideration. Then Orphan Medical
began lobbying to keep GHB from being controlled, and this doctor
suddenly changed his tune. I was contacted by a man who said he was the
president of Orphan Medical, trying to change my stance. I was amazed
that he could not answer some very basic questions about this oh-so-
safe drug he was pushing so hard to protect.
The FDA has been more outgoing in recent months in response to
problems arising from over the counter marketing of GHB's precursor and
dangerous analog, sold as Blue Nitro, Remforce, Renewtrient,
Revivarant, Re-energize and Firewater. But there is so much more to be
done on the GHB topic in terms of legislation, education of law
enforcement and public awareness.
1) Accurate and immediate federal legislation to control GHB as a
Schedule I drug needs to be finalized. This will also provide
guidelines to assist the more than 30 states still needing to complete
legislation and will hopefully result in more continuity. Currently it
is listed in Schedules from I to IV in the states who have made an
effort.
2) Accurate and prompt training information on this drug and
improved drug testing protocols need to be provided nationwide to
assure enforcement intervention in the trafficking and abuse of GHB.
This drug has numerous active analogs, making testing and standardized
knowledge throughout law enforcement critical. In California a young
man made it through the criminal justice system 2\1/2\ times as an
``alcohol only'' drunk driver, when in fact, he was an alcohol and GHB
drunk driver. Each time his bizarre behavior didn't match his low blood
alcohol (BA). Standard drug testing showed no other drugs. Fortunately
his first case resulted in a conviction, despite the low BA, setting
him up for more serious punishment later. His second case was treated
as a ``reckless'' because of a very low BA, though with bizarre
behavior. The third time, just a few weeks later, an innocent 27 year
old died instantly, his car exploding on impact by the suspect's
vehicle. He has since pled guilty and is spending 14 years in prison.
The victim's mother, who described him as ``a good kid who loved
basketball and was never a problem,'' would love to have been here
today to express her pain to you.
3) Education/publicity is crucial in counteracting the widespread
misinformation about GHB and its analogs. Approximately 95 percent of
the information on the Internet about GHB is inaccurate and misleading.
About six months ago, I would have said 99.9 percent of it was
inaccurate. The change has been made mostly by citizens and doctors
trying to make a difference, and especially by one website in
particular (www.ashesonthesea.com/ghb/), maintained by the parents of a
25-year-old casualty of GHB. GHB websites overwhelming claim that GHB
is safe, non-addictive and can cure all things, besides being a lot of
``fun.'' GHB is truly the Child of the Internet. The truth is, GHB is
dangerous, addictive and harder than heroin to shake. I have learned
this not from the FDA, but from the streets and from the referenced
website. The site is currently being overwhelmed by comments from those
who can't shake it and those who have had or seen horrid experiences
from it. The input is coming in from all over the United States and
Canada. For those of you with any doubts about how dangerous and
widespread this drug is, the commentary pages of that site will forever
erase your doubts.
GHB is the easiest drug on earth to make and the hardest drug to
recognize.
What parent would suspect that seeing their son or daughter sip
repeatedly from a common sports water bottle might foretell a deadly
addiction?
Mr. Upton. Thank you. We have a little bad news from the
House floor in that when this vote is over, we have 10 minutes
of debate, and then we will have five votes bang, bang, bang.
I think it would be best at this point to recess until
probably about 11:30 a.m. So we will give you a little hour to
visit your Member of Congress, watch what is going on on the
floor, but we will come back at as close to 11:30 a.m. as we
can.
[Whereupon, the subcommittee recessed, to reconvene at
11:30 a.m., the same day.]
Mr. Upton. Thank you all for being back here promptly. Our
votes are over now for a little while, so we will resume with
testimony by Ms. Dyer.
TESTIMONY OF JO ELLEN DYER
Ms. Dyer. Thank you. Mr. Chairman and members of the House
committee, I am appearing before you to discuss my concerns
about the potent new drug of abuse, gamma hydroxy butyrate,
known as GHB.
The California Poison Control System has been assisting in
identification and management of poisonings due to gamma
hydroxy butyrate since we first identified the syndrome and
reported cases to the State Department of Health and the FDA in
1990.
We reported the severe effects from its misuse. It is used
as a nutritional supplement for body building, a drug of abuse
for euphoria, a purported sexual enhancing drug and as an
incapacitator for assault.
In 1998, we consulted on 232 cases of poisoning in
California from GHB and its related products. I will tell you
about some of our patients' experiences.
A 26-year-old female poured GHB into a glass to drink as an
appetite suppressant for dieting. Almost immediately, she felt
nauseated and went in the bathroom to vomit. She lost
consciousness, fell on the floor, cut her head. Her sister
witnessed seizure like jerking. She was vomiting. She was
incontinent.
When the ambulance arrived, she was comatose, agitated,
vomiting. Her heart rate had slowed. Airway support was
necessary because she was vomiting while she was unconscious.
She required admission overnight to the critical care unit. The
life threatening clinical effects of GHB can cause an abrupt
loss of consciousness, profound coma, and they can compromise
breathing.
A 23-year-old female college student and body builder was
taking three to five capfuls of liquid GHB for 1 year for the
alleged anabolic effects. Over a 6-week time period, she
increased her dose and frequency to every 3 hours around the
clock to prevent the anxiety, tremors and insomnia she
experienced without it.
She was admitted to a medical detoxification center, and
GHB was discontinued. She became increasingly paranoid,
experienced vivid hallucinations, disorientation and delirium.
Her rate increased.
As this delirium syndrome progressed, she was transferred
to an intensive care unit under heavy sedation and physical
restraint to prevent injury, muscle breakdown and uncontrolled
fever. She experienced a withdrawal course over 9 days.
Frequent ingestion of GHB can lead to addiction and a severe,
life threatening withdrawal syndrome.
A 29-year-old woman went to a party with her date. Her last
memory was dancing with him. She awakened to find a man
assaulting her. He claimed that her date had passed out and
that she had consented to have sex with him. The response, when
she called 911, was that without a description of events and no
physical evidence of force, there was nothing that could be
done.
A second report from that same location established a
pattern. The victim identified the drug that was used. A search
at that location revealed greater than 2,000 photos, videos,
recipes to make GHB and margarita salt containers of GHB. Some
of the victims that were identified from those photos did not
even realize they had been raped.
This serial predator, a 38-year-old male, was convicted on
43 counts, receiving 77 years for sexual assaults and
poisoning. He had placed GHB from an eyedropper carried in his
shirt pocket into the drinks of his unsuspecting victims. GHB
is easily used to incapacitate a victim, allowing physical or
sexual assault.
A 71-year-old man, taking one teaspoon of gamma
butyrolactone nightly for sleep, mistook the bottle at his
bedside for water, and he drank some. Within 30 minutes, his
wife found him slumped in a chair unconscious. She called 911.
Paramedics found him not breathing.
In the emergency department, his depressed breathing was
supported with mechanical ventilation. His heart rate was slow
at 40 beats per minute, and he was profoundly unconscious. He
was admitted to intensive care overnight.
The label on that product instructed, ``Insure that those
around you are aware that you may be unarousable and that this
is normal. Unless drugs or alcohol have been ingested, the only
treatment necessary is to sleep it off.'' Following these
instructions could have been fatal.
GHB and its precursors, gamma butyrolactone and 1,4-
butanediol, are promoted for many unsubstantiated health
claims, while denying the dangers of their use. GHB and their
precursors have demonstrated their abuse potential, their
dependence liability, and they have been used to commit
assault.
GHB and its precursors are a health hazard, and I want to
emphasize the importance of placing GHB in a schedule that will
stop the proliferation of these analogs also.
Thank you.
[The prepared statement of Jo Ellen Dyer follows:]
Prepared Statement of Jo Ellen Dyer, Pharm.D. CSPI, Sr. Toxicology
Management Specialist, California Poison Control System, San Francisco
Division, Assistant Clinical Professor of Pharmacy, University of
California San Francisco
Mr. Chairman and members of the House Subcommittee on Oversight and
Investigation: I am appearing before you today to discuss my concerns
about a potent new drug of abuse gamma hydroxybutyrate, GHB. Individual
states have legislated GHB as a controlled substance due to the severe
health effects from its misuse as a nutritional supplement for
bodybuilding, a drug of abuse for euphoria, a purported sexual enhancer
and an incapacitator for assault.
The California Poison Control System has been assisting in the
identification and management of poisonings due to gamma
hydroxybutyrate and its related products since we first identified the
poisoning syndrome and reported the cases to the California State
Department of Health and the FDA in 1990. Since that time we have
continued to track, identify and report the new trends in abuse of this
drug. See the attached reference list of our published medical
literature on this subject.
The primary dangers of GHB
1. The life-threatening clinical effects of GHB can include an
abrupt loss of consciousness, profound coma, and compromised breathing.
2. Frequent ingestion of GHB can lead to addiction and a severe
life-threatening withdrawal syndrome.
3. GHB is easily used to incapacitate a victim allowing physical or
sexual assault.
4. GHB and its precursors, gamma butyroiactone and 1,4-butanediol,
are promoted for many unsubstantiated health claims while denying the
dangers associated with their use.
The life-threatening clinical effects of GHB can include an abrupt
loss of consciousness, profound coma, and compromised breathing. GHB is
a powerful anesthetic drug, a depressant. It was developed in France in
1960 and evaluated as an anesthetic because it reliably induced rapid
onset of coma. However, lack of pain relieving properties and unwanted
side effects such as delirium decreased enthusiasm for its use.
Although GHB was considered safe when used under direct supervision of
a physician in surgical procedures, side effects still occurred. These
side effects slowed heart rate; muscle jerking; agitation; and vomiting
were controlled with the addition of other medications. GHB was not
used as an anesthetic alone nor was it used without qualified medical
supervision.
GHB now is abused in unsupervised situations where fatalities have
occurred from the abrupt loss of consciousness resulting in injury,
suffocation when the airway is blocked, and depressed breathing. Since
1995 GHB has been implicated in the deaths of at least six young
people, ages 15-34, in California. Because blood tests for the presence
of GHB have only recently become available, many fatalities have not
been recognized as being caused by GHB, and this number may represent
only the ``tip of the iceberg''.
The clinical effects of GHB are well known:
Profound Coma--not just a deep sleep. Noise or pain cannot
awaken you
Myoclonus--involuntary muscle jerking
Bradycardia--slow heart rate
Respiratory depression--slowed or stopped breathing
Loss of airway protective reflexes that keep breathing
passages open and fluid and vomit out of the lungs
Vomiting
Incontinence--involuntary passage of urine or stool
Chemical burns from incorrect manufacture using alkaline
chemicals
GHB became a controlled substance in California in 1997. That year
the California Poison Control System was consulted about 199 cases of
poisoning from GHB and related products. Last year (1996) there were
232 reports to the California Poison Control System. The reporting of
poisonings to the California Poison Control System is not mandatory and
the number of reports undoubtedly underestimates the number of GHB
poisonings in the state. Abuse was seen across all age groups in 1998.
23% of patients were under 21 years old, 46% were 21-29 years old, 23%
were 30-39 years old and 6% greater than 40.
An evaluation of 88 cases treated in San Francisco General Hospital
over three years revealed 50% of cases ingested GHB with another
intoxicating substance. Importantly 50% of the patients ingested GHB
alone. The severity of clinical effects with GHB does not rely solely
on other drugs ingested. GHB taken alone is dangerous.
Frequent ingestion of GHB can lead to addiction and a severe life-
threatening withdrawal syndrome. The misleading claims such as improved
physique with no physical effort are persuasive enough that some
patients take GHB frequently and as a result become addicted. These
patients can experience a severe withdrawal syndrome that may last up
to 2 weeks after GHB was discontinued. The withdrawal symptoms begin
within just a few hours after the last dose of GHB. Early symptoms,
insomnia, tremor, confusion, nausea and vomiting are mild and progress
over 2-3 days. Then the more severe central nervous system symptoms of
agitation, disorientation, and vivid hallucinations occur. The
cardiovascular system reacts with a rapid heart rate. As this delirium
syndrome progresses, heavy sedation and physical restraint are required
to prevent injury, muscle breakdown, and uncontrolled fever. Intensive
care is necessary over 1-2 weeks.
GHB is easily used to incapacitate a victim allowing physical or
sexual assault. GHB produces a fast onset of profound coma that leaves
a victim defenseless to assault. These cases are very difficult to
prosecute due to amnesia for the events and the loss of consciousness
that occurs minutes after ingestion of GHB. In addition, laboratory
confirmation is difficult due to the short duration that GHB is
detectable in the system. The profound central nervous system
depression that occurs with GHB leaves victims incapable of resisting
assault.
GHB and its precursors, gamma butyrolactone and 1,4-butanediol, are
promoted for many unsubstantiated health claims while denying the
dangers associated with their use. GHB and its precursors are easily
available. They can be ordered over the Internet, purchases as kits for
home manufacture or made according to detailed recipes for kitchen
synthesis that are posted on the Internet starting with uncontrolled
chemicals. The information promoting these products often makes
outrageous claims such as: improved physique with no physical effort by
increasing muscle mass and definition while decreasing fat, relief from
depression or chronic fatigue syndrome, enhanced virility, smoother
younger skin, and reversal of male pattern baldness. GHB products are
claimed to be ``non-toxic'' and the label on one product instructs you:
``to ensure that those around you are aware that you may be unarousable
and that this is normal. Unless drugs or alcohol have been ingested the
only treatment necessary is to sleep it off.'' Unfortunately, following
these instructions may be fatal. Many of our patients wake up in a
hospital intensive care unit shocked that this ``natural'', ``non-
toxic'', substance caused their life-threatening condition.
The California Poison Control System continues to track and report
trends in GHB abuse. We also provide education to the public, health
care practitioners, and emergency medical response teams through phone
consults, lectures, and publications. We have been active in training
law enforcement, district attorneys, rape treatment counselors, FDA and
DEA personnel in recognizing this new drug of abuse.
GHB and its precursors have demonstrated their abuse potential,
their dependence liability, and they have been used to commit assault.
GHB and its precursors are a health hazard. I am concerned about the
ease of availability of GHB compounds.
Mr. Upton. Thank you.
Lieutenant Bane?
TESTIMONY OF PAUL BANE
Mr. Bane. Mr. Chairman and members of the committee, good
morning, and thank you for the invitation this morning.
During the week of February 7, 1999, five students were
admitted to the emergency room at Salisbury Peninsula Hospital.
We had an opportunity to speak with 3 of the 5 individuals, all
of whom admitted to taking GHB and knew that they were doing so
before they took it.
According to the emergency room staff after this incident,
it would have been a fatal overdose for one of the individuals
that had been admitted had she not gotten emergency room
treatment.
In the exhibits that I gave you this morning, I have quoted
a number of statistics involving death and abuse while under
the influence of GHB. I am not going to regurgitate those
statistics now. They are also the handiwork of DEA, and I am
not going to steal their thunder.
We are just reaching the tip of the iceberg of GHB
instances in the State of Maryland. After the incident occurred
in Salisbury, I took a personal approach to contacting all the
major universities in the State of Maryland to see if they
could identify the number of abuses and incidents that they
have had in the State. Much to my surprise, they indicated that
there were no reported instances of GHB abuse.
Finding this somewhat to difficult to believe, I began
questioning the police departments that were at those schools
and began asking them pointed questions with regards to sexual
assaults and things of that nature occurring at the schools
where the victim either could not remember or had very little
recollection of what had happened to them. Lo and behold, cases
began to surface.
In remarks made earlier, I heard some comments with regard
to education, and I think education is not only going to be
important for the public, but I also think education is going
to be necessary for the law enforcement community, as well as
getting some reliable form of test kit available to the law
enforcement community.
Maryland recognizes that these problems are very serious.
The State police has proposed legislation to the State Senate
with regards to scheduling Ketamine, and I also have in my
possession a position paper from the Maryland State Police
where we are recommending that it be made illegal to administer
any drug in someone else's drink for the purposes of possible
sexual advances.
Thank you.
Mr. Upton. Thank you.
Dr. Adatsi?
TESTIMONY OF FELIX ADATSI
Mr. Adatsi. Thank you, Mr. Chairman, and members of the
committee.
The discreet use of sedative drugs to overwhelm and/or----
Mr. Upton. If you would just pull the mike a little closer?
Thank you.
Mr. Adatsi. Thank you.
The discreet use of sedative drugs to overwhelm or
incapacitate the victim for purposes of perpetrating a crime is
an age-old forensic toxicology problem. When used to commit a
crime of sexual assault, sedative drugs may be classified as
date rape drugs.
Recently, attention has focused on the involvement of gamma
hydroxy butyrate or GHB, gamma butyrolactone, GBL,
Flunitrazepam, Rohypnol, and possibly Ketamine in drug-induced
sexual assault cases.
In the majority of cases, the scenario is fairly similar,
and it involves women who may be at parties in which alcoholic
beverages are consumed. My presentation will examine the
toxicological effects, the abuse potential, and the dangers
posed by the indiscriminate exposure to these four drugs.
GHB is naturally occurring, and it is a metabolite of gamma
aminobutyric acid in the human brain, and it occurs in other
organs and tissues of the body. When administered in
pharmacological doses, GHB is a potent central nervous system
depressant.
The current availability of the drug is limited to
investigational use only. GHB is manufactured in illicit labs,
and simple, home-brewed recipes are available on the Internet
and other underground publications. The starting material for
GHB manufacture is GBL, which is fairly easy to obtain.
GHB is popular with a variety of abusers in the U.S.,
including high school and college students, bodybuilders and
athletes. In this context, it has various names. It has been
referred to as Georgia home boy, liquid ecstasy, liquid X, easy
lay and scoop.
The popularity of GHB among abusers appears to be related
to its promotion as a steroid alternative, as a sleep inducing
agent and also as an agent that is capable of enhancing
athletic and sexual performance.
GHB occurs as a clear, colorless, viscous liquid, which is
heavier than water. It is tasteless and mixes very easily with
water and other beverages. It can also occur as a powder and is
found in gel caps. However, it is its property as a clear,
colorless liquid with high solubility in water that facilitates
its clandestine introduction into drinks and beverages of
unsuspecting victims.
The onset of action of GHB is fairly rapid. In fact, in
five to 30 minutes following ingestion, GHB can begin to take
its effect. It has a relatively short half life; that is to say
that 50 percent of the drug will be metabolized and broken in
the body in a relatively short time. On the average, after 30
minutes of full exposure, 50 percent of the drug will be broken
down.
The effects are varied and depend on the person who is
consuming the drug, but include drowsiness, euphoria,
dizziness, visual disturbance, nausea, unconsciousness, and
this may persist up to about 3 hours.
Serious adverse reactions may include hallucinations,
seizures, vomiting, severe respiratory depression and coma.
Now, the adverse effects may also last up to 96 hours. If death
occurs, it is normally due to a collapse of the cardiovascular
system and respiratory depression.
The effects of GHB are further enhanced by the simultaneous
administration of other CNS depressants. GHB has been
implicated in deaths in your State, in about five cases in
Michigan.
Like GHB, GBL has also been implicated in alleged sexual
assault cases and death. GBL has commercial and industrial
applications and is used as a solvent, a paint remover and as a
dietary supplement. GBL is found in products marketed under
names such as Renewtrient, Revivarant, Blue Nitro, GH
Revitalizer and Gamma G.
Both GHB and GBL are chemically very similar. The
toxicological effects of GBL include CNS depression, seizures,
unconsciousness, vomiting and coma.
The next drug, Rohypnol, belongs to the class of compounds
known as benzodiazepines. In this class of compounds there is
Valium, except that Rohypnol is only about ten times more
powerful than Valium. Rohypnol is manufactured by Hoffman
LaRoche and is used in a number of European countries as a
hypnotic and as an anesthetic inducing agent. It has also been
implicated in several sexual assault cases around the country.
The final drug I want to discuss is Ketamine, which is also
used to induce anesthesia in the U.S. and has been available
since 1972. Ketamine is reportedly capable of producing the
same hallucinogenic effect as PCP.
Our current findings suggest that GHB has a high abuse
potential and has no current medical application. GHB is
controlled as a Schedule I drug in the State of Michigan. It
has serious toxicological and clinical side effects and has
been implicated in a number of deaths across the country. It is
elusive in detection, and controversy exists as to what
constitutes an endogenous level, which will distinguish it from
an exogenous level. Because of its close structural
relationship to GHB and the fact that GBL can be converted to
GHB, GBL also poses similar toxicological concerns for the
entire population.
In light of the mounting evidence of abuse, toxicity and
use as weapons of crime against these drugs, their use should
be restricted or controlled.
Thank you.
[The prepared statement of Felix Adatsi follows:]
Prepared Statement of Felix Adatsi, Ph.D Toxicologist, Michigan State
Police, East Lansing, MI
Should Date-Rape Drugs be Controlled
The discreet use of sedative drugs to overwhelm or incapacitate a
victim for purposes of perpetrating a crime is an age old forensic
toxicology problem. When used to commit a crime of sexual assault,
sedative drugs may be classified as date-rape drugs. Recently,
attention has focused on the involvement of gamma hydroxy butyrate
(GHB), gamma butyrolactone (GBL), flunitrazepam (rohypnol) and possibly
ketamine in drug-induced sexual assaults cases. In the majority of
cases, the scenario is fairly similar, involving women who may be at
parties in which alcoholic beverages are consumed. This presentation
examines the toxicological effects, abuse potential and the dangers
posed by the indiscriminate exposure to the four drugs listed above
which may warrant their control.
GHB is a naturally occurring metabolite of gamma-aminobutryic acid
in the human brain and in most other mammalian tissues in small
amounts. When administered in pharmacological doses, GHB is a central
nervous system depressant and has been used clinically as an anesthetic
and hypnotic agent. The current availability of the drug is limited to
investigational use only. GHB is manufactured in illicit laboratories
and simple, home-brew recipes are available on the internet and in
other publications. The starting active ingredient in these recipes is
GBL. GHB is popular with a variety of abusers in the U.S., including
high school and college students, body builders and athletes. In this
context it has been referred to by several names to include Cherry
meth, Georgia home boy, Liquid ecstasy, Liquid X, Easy lay, Natures
quaalude and Scoop. The popularity of GHB among abusers appears to be
related to its promotion as a steroid alternative, sleep inducing
agent, and an agent capable of enhancing athletic and sexual
performance.
GHB occurs commonly as a clear, colorless, viscous liquid, which is
heavier than water. It is tasteless and mixes easily with water and
other beverages. GHB also occurs as a powder and has been found in gel
caps. However, it is its property as a clear, colorless and tasteless
liquid with high solubility in water that facilitates its clandestine
introduction into the drinks and beverages of unsuspecting victims.
Once consumed in this fashion several effects and symptoms are possible
and the victim is predisposed to a variety of criminal activities.
The onset of action of GHB following ingestion occurs within 5 to
30 minutes. GHB has a relatively short half-life (20-60 minutes). The
effects are varied and depend upon the individual and the dose
consumed. Effects include drowsiness, euphoria, dizziness, visual
disturbance, nausea, and unconsciousness and may persist for about 3
hours. Serious adverse reactions include hypotension, hallucinations,
seizures, vomiting, severe respiratory depression, and coma. These
effects may persist for 2 to 96 hours or longer. Death may be due to
severe respiratory arrest and collapse of the cardiovascular system.
The effects of GHB are further enhanced by the simultaneous
administration of other central nervous system depressants such as
alcohol and benzodiazepines. GHB has been implicated in about 5 deaths
in Michigan. Like GHB, GBL has also been implicated in alleged sexual
assault cases and death. GBL has commercial applications, being used as
a solvent, paint remover and dietary supplement. GBL is found in
products marketed under brand names such as Renewtrient, Revivarant,
Blue nitro, GH Revitalizer and Gamma G. GHB and GBL are chemically very
similar. Indeed it is reported that GBL is converted into GHB in the
body. The toxicological effects of GBL include central nervous system
depression, seizures, unconsciousness, vomiting and coma.
Rohypnol belongs to the class of compounds known as
benzodiazepines. In this class of compounds is valium and the effects
of Rohypnol are believed to be similar to valium but is about 10 times
more powerful. Rohypnol is manufactured by Hoffman-La Roche and used in
a number of European countries as a hypnotic and anesthetic inducing
agent. Rohypnol abuse has been reported in middle schools and high
schools, as well as by college students. It has been implicated in
several alleged sexual assault cases around the country. The effects of
Rohypnol occur within 20 to 30 minutes of ingestion and the symptoms
include decreased blood pressure, muscle relaxation, dizziness,
sleepiness, amnesia, mental confusion, and lethargy. When taken in
combination with alcohol or other central nervous system depressant
drugs, the side effects may progress to death.
Ketamine has been used as an anesthetic induction agent in the U.S.
since 1972. Its structure and pharmacological properties are similar to
phencyclidine (PCP). Ketamine is reportedly capable of producing the
same halucinogenic side effects as PCP. Ketamine is usually available
by intravenous or intramuscular injection. Recently however, Ketamine
has been implicated in alleged sexual assault cases. Indeed, in a
recent GHB related case in Michigan, Ketamine reportedly was detected
in a container which also contained GHB.
Current findings suggest that GHB has a high abuse potential and no
current medically accepted application. GHB has serious toxicological
and clinical side effects and has been implicated in a number of deaths
across the country. It is elusive in detection and controversy exists
as to what constitutes an endogenous level to distinguish it from a
deliberate exposure for prosecution. Because of its close structural
relationship to GHB, and the fact that it can be converted to GHB in
the body, GBL also poses similar toxicological concerns for the entire
populace. Rohypnol has been implicated in several sexual assault cases
across the country and has very high abuse potential. In light of the
mounting evidence of abuse, toxicity and use as weapons of crime,
against the above mentioned drugs, their use should be restricted and/
or regulated as scheduled drugs.
Mr. Upton. Thank you.
Ms. Snyder?
TESTIMONY OF DENISE SNYDER
Ms. Snyder. Thank you, Mr. Chairman, and members of the
committee.
I work at the D.C. Rape Crisis Center. We have seen upwards
of two dozen women over the last 3 years who have been sexually
assaulted in a drug-related situation, and I have started to do
a lot of trainings around the country for both State and
national training programs to talk about the issue of substance
related rapes, and I have heard a lot of stories from other
cities and States.
The primary thing that I want to get across today is that I
am concerned that as we try to address this issue we do it in a
way that is addressing the problem, which is drug related
sexual assaults. We must deal with the act and not deal with
the vehicle specifically that is being used because if we focus
on specific drugs, I am afraid that what we are going to do is
2 years down the road find ourselves in the same place that we
are in now.
I was a strong advocate of rescheduling Rohypnol, but I
feel like we spent several years focusing on that. Rohypnol is
now fading from the scene. Other drugs are taking its place. It
is important that we not be sitting here 2 years from now
talking about some other drug and trying to figure out how to
deal with it. We need to deal with the act and not the specific
vehicle.
Some of the specific concerns that come up with women who
are sexually assaulted using some kind of a substance are a lot
of mental health issues. Ms. Pruett mentioned some of them in
her first discussion. Women who are sexually assaulted under a
substance like this do not have any place to direct their
anger. They have no idea who their assailant was, so there is
no way to focus that and work through it in order to heal and
move on.
The second issue comes from the anxiety of the unknowns;
not knowing who was involved or what happened, so every time
you see an individual who looks at you funny you might be
thinking: Was he involved? Was he somebody who was there?
Especially in situations where this happens in a small
community such as a college campus, it can make it extremely
difficult to just continue to be there.
The reactions that are fairly common have already been
mentioned. I would just say that in general the dynamics of how
this happens very much parallels any kind of date rape
situation. We have had clients who were sexually assaulted in
their home, in the assailant's home, at parties. The assailants
have been platonic friends, dates, complete strangers or an
acquaintance that was just met. It has happened in gay and
lesbian relationships, as well as in straight relationships,
and the age range is from early teens up through women in their
forties.
It is also important to recognize that it is not only using
alcohol. As several folks have mentioned, we have had cases
where women were drinking tea, sodas, women who do not drink
alcohol at all. It makes it very difficult, I think, for a lot
of women to try to defend themselves.
I also want to mention that in trying to deal with this
problem, as a couple of other witnesses have already said, it
is extremely important that education be a major component.
For Congress to pass legislation that tries to deal with it
but the information about it does not get out to the general
public, to law enforcement, and also to district attorneys and
to the medical personnel who are dealing with these women, if
that information is not gotten out there in a way that is
accessible to them the value of the legislation is going to be
greatly minimized.
In closing, again I would just ask that what we do is try
to make sure we are focusing on dealing with the problem and
the act of using substances to sexually assault women and not
focus specifically on vehicles.
Thank you.
Mr. Upton. Thank you all, witnesses. I want you to know
that for many of us we serve on multiple subcommittees, and
they all seem to meet at the same time in different buildings.
I know that Mr. Dingell, the ranking member of the full
committee and a member of this subcommittee, would have liked
to have been here to introduce a witness from his district.
Knowing that he is back, I would like to recognize him first
for the first order of questions. Mr. Dingell?
Mr. Dingell. Mr. Chairman, thank you. I would like to
welcome not only my constituents here, but the entire panel.
Thank you for being here, and thank you for your very fine
assistance.
Mr. Faistenhammer, I particularly want to welcome you. Now,
I would address quickly, and I would note that you have been
giving good information about the problems associated with
these kinds of drugs nationwide. I am concerned a bit more
about how we can assist you in your efforts with regard to GHB
and Ketamine.
You are a law enforcement officer. Can you explain in
detail the problems that Michigan has had with the two drugs
just mentioned? GHB appears to be more of a problem in Michigan
than does Ketamine; would you like to comment, sir?
Mr. Faistenhammer. Yes. One of the key problems is we do
not have a method for testing on the street. As you can see
just here in front, it comes in various numbers of containers.
The uniformed officers that run into these types of
containers on the street, even if they were smart enough to
suspect GHB through training, they would not have a method of
checking on the street as to what is in the container.
So, it is really a two-pronged assault I think from the
State of Michigan for us in policing. One, we need to educate
our officers. Two, we need some method to be able to show that
there is some sort of field test available, sir.
Mr. Dingell. Would it be helpful if we federally scheduled
both GHB and Ketamine?
Mr. Faistenhammer. Yes, it would be.
Mr. Dingell. Is that the consensus at the table? Does
anyone disagree with that?
[No response.]
Mr. Dingell. Mr. Adatsi, do you wish to add anything to
that?
Mr. Adatsi. Other than the fact that with the schedule at
the Federal level I think and very stiff penalties, I think
that will help, and also to improve education nationwide for
this particular drug and how insidious the drug can be.
Mr. Dingell. Thank you.
Mr. Faistenhammer, you, I am sure, are aware that both Mr.
Stupak, one of my good friends and colleagues from Michigan, as
a matter of fact a former member of the Michigan State Police,
and also Ms. Jackson-Lee, a very fine Member, have for a long
time recognized problems associated with both GHB and Ketamine.
For some 2 years now they have submitted legislation which
scheduled both of these drugs. Am I fair in assuming that you
would support the idea that these drugs should be federally
scheduled?
Mr. Faistenhammer. Yes, they should be.
Mr. Dingell. Mr. Adatsi?
Mr. Adatsi. I believe so.
Mr. Dingell. Mr. Faistenhammer, do you believe that
scheduling would give additional tools for law enforcement? If
so, could you tell us how those tools might be used?
Mr. Faistenhammer. I do believe it would give us the tools
that we need, as least as far as I can think of immediately
right now as we would be getting Federal assistance. The Drug
Enforcement Administration, the FBI, those agencies would come
on board.
Mr. Dingell. You also would have the benefit of the seizure
laws, would you not?
Mr. Faistenhammer. That is correct.
Mr. Dingell. That would be a particularly significant
benefit, would it not?
Mr. Faistenhammer. If it would become scheduled, yes.
Mr. Dingell. So if somebody set up a manufacturing
operation in his basement, you could seize the house?
Mr. Faistenhammer. That is correct.
Mr. Dingell. That is something of a deterrent, I gather?
Mr. Faistenhammer. Yes. Yes.
Mr. Dingell. Mr. Adatsi, do you wish to add anything to
that?
Mr. Adatsi. No. We have had precedents here in other cases,
other drugs before, so by forming a particular type and process
we would have been doing something that has precedent.
Mr. Dingell. Now, Mr. Faistenhammer, you mentioned that the
State police in Michigan are in need of a field test kit. Is
there a test kit of that sort which does exist?
Mr. Faistenhammer. No, there is not.
Mr. Dingell. So you would have to have one developed? Is
that right?
Mr. Faistenhammer. That is correct.
Mr. Dingell. As I understand the chemical processes and
chemical engineering and so forth, the development of a test of
that sort with a proper exercise of resources is not awfully
hard, though. Is that not true?
Mr. Faistenhammer. It seems to be in this particular case
that it is in that many of the things that you would utilize to
break down GBL, as an example, would turn it into GHB.
Mr. Dingell. All right. Now, Mr. Adatsi, is there anything
we can do to help you in your efforts on addressing this GHB
problem in Michigan?
Mr. Adatsi. Well, my laboratory currently does not test for
GHB. We do have a lot of support from the Department already.
Other than the fact that this should be scheduled at the
Federal level and the education and training for law
enforcement personnel, I think that would be my request at this
point.
Mr. Dingell. Mr. Chairman, I think my time has expired. I
thank you for your courtesy, and I thank you for holding this
hearing.
Ladies and gentlemen of the panel, we appreciate your
assistance and courtesy. Thank you.
Mr. Upton. Thank you, Mr. Dingell.
Ms. Pruett, I know that the night that you were raped you
also I think had a friend with you that went along. What
happened to him or her? Tell us a little bit about that.
Ms. Pruett. Her trial was separate from mine.
Mr. Upton. She was raped as well?
Ms. Pruett. They could not prove her being raped, but--I do
not know much about her trial.
Mr. Upton. Did she also end up in a coma as you did?
Ms. Pruett. I am not sure.
Mr. Upton. Okay. The question Mr. Dingell asked about
trying to put GHB as a little tighter schedule, I or II. I have
a question, and one of the concerns I have is how easy it is to
manufacture GHB and one of its analogs.
My own personal belief is that we ought to have it on a
schedule high enough so that one of its analogs, whether it be
GBL or some other derivative, would not be the next in line and
would simply take its place, and we would all of a sudden get
into this game of finding out what is next.
I would be interested to know what your comments, maybe
with Ms. Porrata first, having some reference from the State of
California and others that might want to comment.
Ms. Porrata. Well, one of the problems is it does have
several active analogs, and these are only two of them, GBL and
1,4-butanediol. Most States do have an analog law, as we do,
and the Federal Government does, too, that covers Schedule I
and Schedule II.
I think if you put it in Schedule III or IV, even if you
put special wording next to it that adds the analogs again the
system is already in place. Analogs are covered in the top two
schedules.
It is really important. There is a slight problem with GBL.
It is a precursor also, so people get confused by that. It
might be important to go ahead and actually designate it as an
analog to clear up that issue so that it is also covered
because there is some chaos over that.
Mr. Upton. California was one of the two States I think
that was referenced. Ms. Sheila Jackson-Lee indicated there
were two States that on their own had designated it as Schedule
I, I believe, California and Pennsylvania.
Ms. Porrata. Actually, there are 17 States that have.
Mr. Upton. Seventeen States? Okay?
Ms. Porrata. But some of them are Schedule I. Some are
Schedule II. We are actually Schedule II. Again, it was because
of this controversy that a doctor came in and said oh, I want
to use it for narcolepsy. The legislators said well, we should
make it available by making it Schedule II.
Making it Schedule II in California did not approve it, nor
did it allow it to be prescribed. That was one of the problems.
It ended up Schedule II, but we do have an analog law so
technically it is covered.
Again, the precursor issue became very confusing. I think
we are probably going to end up clarifying that with
legislation to make it crystal clear that GBL is equal to GHB
under California law.
Mr. Upton. Dr. Adatsi, did you want to comment on that?
Mr. Adatsi. Well, that----
Mr. Upton. Again, if you could put that mike particularly
close?
Mr. Adatsi. Thank you.
Mr. Upton. That would be helpful.
Mr. Adatsi. Yes. In my presentation, I did emphasize that
because GBL is a precursor to GHB, the use or access to GBL
should also be restricted.
As Ms. Snyder did indicate, it will not be a bad idea to
have a statement that is quite encompassing for this CNS
depressant so that a year or a couple years from now we do not
revisit this same issue.
In the State of Michigan GHB is a Schedule I, and the
language is isomers or a sort of an isomer. It does not
specifically speak to GBL. I suppose an aggressive prosecutor
could find somebody to interpret that to refer to GBL as well.
However, if the Federal schedule is such that GBL could be
included, I think that will in the long run serve a very useful
purpose.
Mr. Upton. The case that really prompted me to begin the
work to have this subcommittee hearing today was the case in
Grosse Ile back in January. I guess my next question would be
if Michigan has this already labeled as Schedule I, do we know
what the drug was yet in terms of the woman that died in Grosse
Ile, the 15-year-old?
Maybe Sergeant Faistenhammer and you both would like to
just comment, and I will yield to Mr. Stupak. If we are at
Schedule I already, how did that impact the death of the young
woman in Michigan?
Mr. Faistenhammer. There may have been some GBL involved in
that case, as opposed to GHB.
Mr. Upton. And that would have been a loophole because of
the----
Mr. Faistenhammer. Because there is some argument as to
whether GBL is an analog or not.
The Wayne County Prosecutor's Office has not issued
warrants on that case and will not until Monday, so they are
sort of asking me to hold off on saying too much about it.
Mr. Upton. Okay. Did you want to just quickly comment?
Mr. Adatsi. Yes, sir, and that is because I had the
privilege of speaking with a prosecutor who was going to
prosecute his case only last week.
He did indicate that they did find GHB in the decedent's
system and also GBL. The alleged perpetrators are swearing that
it was GBL they administered to this lady. However, upon
analysis the levels of GHB found in the decedent are large
enough to suggest that there must have been some exogenous
administration to this lady.
I suppose that together with the law in Michigan, with the
proper questioning this particular case should not fall through
any cracks.
Mr. Upton. Okay. Thank you.
Mr. Stupak?
Mr. Stupak. Mr. Chairman, if you have more questions, go
ahead.
Mr. Upton. No. Go ahead, Bart. I do have another question
or two, but I will----
Mr. Stupak. I would prefer that you----
Mr. Upton. Do you want me to go? All right. Without
objection.
Mr. Stupak. No objection.
Mr. Upton. I am interested in how these drugs are coming
into the hands of some of these folks. I know recently we had a
demonstration here as I opened up my remarks in terms of its
access on the Internet, but it really is pretty easy. We did
that in our office a couple weeks ago, to show me just how easy
it was.
It was very disturbing in fact when you saw that at the end
of the scroll where you could plug in your Visa card or your
American Express and literally have it delivered to whatever
address you wanted the next day, including a how-to kit and
eyedroppers and a whole number of different items of
paraphernalia that I guess would make it easier for someone to
get this material off the Internet.
In your relationships on the panel, have you seen the
Internet being used to get this into the mainstream of our
society? Maybe I would like to start with Ms. Snyder as one who
is really on the front lines of these types of issues.
Ms. Snyder. Yes. Accessibility is not at all an issue. I
mean, it is very easy to get. One of the problems that comes
with that, however, is the potency is always varied because you
took this amount last time, and you got this desired result.
You take the same amount next time. The potency could be
completely different, and you could either end up in a coma or
perhaps death.
Mr. Upton. Our police officials, do you recognize that the
Internet has been a great tool for some of these folks?
Mr. Faistenhammer. Yes. We recently seized computers out of
several defendants' homes. All are using the Internet. All are
shipped via UPS and ordered over the Internet.
Mr. Upton. Ms. Porrata?
Ms. Porrata. This is truly the child of the Internet. I do
not think any other drug has been delivered across the board in
the way that GHB has through the Internet.
It is illegal to sell the kits to make GHB. The Department
of Justice has already handled some cases on that. The hard
part, of course, is finding these people. In one of the cases,
they----
Mr. Upton. It is pretty easy in our office.
Ms. Porrata. Well, I mean it is easy to find them and order
it. I am talking about physically find them to arrest them.
I think one of the cases they did he was arrested in
Florida. There was property actually seized, warehousing seized
in two or three other States. We took money out of his bank
account in L.A. and New York and Florida, so it is not really
easy to physically find them.
The problem is again the GBL issue. They believe that it is
more legal to ship GBL around if you are not putting it in a
kit. That is again where Federal leadership is so critical.
We need Federal laws and Federal scheduling for two things.
One, so that that issue is clear cut at the interstate level,
because that is what it involves here, and, two, you need to
set a precedent to help these poor States.
States still have to pass the laws in order to make
arrests, but they could use some guidelines and some guidance.
Right now the States that have it, it is Schedule I, Schedule
III, Schedule IV. We could use some leadership here.
Mr. Upton. Ms. Dyer, do you have anything to add to that,
or Lieutenant Bane?
Ms. Dyer. These products, the Gamma G came in with a 42-
year-old woman. She ordered it over the Internet.
This is a kit that a 30-year-old man had used and had
become dependent on it, had repeatedly ordered this kit. This
is the gamma butyrolactone. This is the sodium hydroxide
pellets. You mix them together in a pan, and you get GHB.
Mr. Upton. Lieutenant Bane?
Mr. Bane. No, sir. As I have indicated, we are kind of just
getting into this now. We have not had that many cases reported
before this time, and as such the law enforcement community
right now is pretty ignorant of this drug right now.
Mr. Upton. Thank you.
Mr. Stupak?
Mr. Stupak. Thank you, Mr. Chairman. Mr. Chairman, let me
thank you again for holding this hearing.
I think the scope of this hearing here today with our first
two panels, and I know we are going to have more, but certainly
has shown us the scope of the problem we have here, the
frustrations that law enforcement has and others.
Thank you again for your leadership and for scheduling this
hearing. Again, I look forward to working with you to move this
along.
Let me ask a few questions. On the street drug kits there,
Sergeant, any indication of any kind of a common droplets,
whatever, we are going to use out there? Nothing on GHB?
Mr. Faistenhammer. No. Really it is so varied. That is the
problem with it is recognizing it. It is a clear liquid that
comes in so many different containers.
Mr. Stupak. In order to have GHB, you have to have GBL.
Nothing to do to try to detect GBL?
Mr. Faistenhammer. No. There is nothing out there.
Mr. Stupak. Okay. Any suggestions?
Mr. Faistenhammer. No. I have a problem with it. I have
called around trying to get some method----
Mr. Stupak. Right.
Mr. Faistenhammer. [continuing] to street test it so we
would have probable cause for arrest on contact with these
people, even just for the driving offense. They are just not
available.
Mr. Stupak. Mr. Adatsi, or Doctor, did I hear you say that
in Michigan the lab does not test for GHB?
Mr. Adatsi. No. Unfortunately----
Mr. Upton. Could you use the mike?
Mr. Adatsi. Unfortunately, we are currently not able to
test for the GHB. We facilitate, however, the sample
transportation to other labs that are capable of doing so.
Mr. Stupak. What labs around the country are capable then
of doing the testing?
Mr. Adatsi. There is a lab down south in Mississippi. The
name of that lab is Elsoli Lab. The FDA lab, I understand, is
capable of doing that. There is also a lab in California, the
coroner's office in California. They are capable of doing that.
Mr. Stupak. Is the reason why, and I am not trying to put
words in your mouth, but why? Is it a complex test? The cost of
the test? Why is it that we do not have more labs doing this
type of testing if it is a law enforcement problem?
Mr. Adatsi. My opinion is because it is a new drug that is
out there, and it takes a little bit of time for the research
and development to be worked out.
Combine that with the fact that other labs probably already
have their own backlogs and cases to deal with and have not
been able to rise to this occasion as quickly as they would
have.
Mr. Stupak. Is there any talk within Michigan to put this
test within your laboratory system?
Mr. Adatsi. Yes. Actually, I am the head of that lab, and I
have directed research and development to be initiated to try
and address the point.
Mr. Stupak. Okay. Thanks.
Does anyone on the panel think that we should not schedule
GHB or Ketamine? Does anyone think we should not?
[No response.]
Mr. Stupak. Okay. Since GBL is a precursor for making GHB,
and GBL is already a readily available solvent in many
industrial applications, how do we control GBL? Any
suggestions? Ms. Porrata?
Ms. Porrata. Frankly, it only has a few industrial
considerations. It is not really like some huge thing that is
very common. It is easily accessed, but it is not like widely
used. Many of the labs only carried one bottle of it until it
became an abuse factor, and now they carry more.
I think it can be heavily restricted to where, much more
like Ephedrine, it can be put on to where it is tracked much
better. That is a start right there. Again, the issue here
becomes human consumption----
Mr. Stupak. Right.
Ms. Porrata. [continuing] as opposed to industrial use.
Mr. Stupak. On the Ephedrine, and you are right. That is
what we did on my legislation to do Ephedrine to get rid of the
Cat problem. I am sure we do not have it totally wiped out yet.
Again, in my legislation we do have the tracking for GBL,
but any other suggestions you would have along that line? I
mean, you have to have GBL to get GHB, right? That is the key
ingredient is GBL?
Ms. Porrata. That is the key ingredient. Again, I think a
big issue is education with so many of these kids. There is a
lot of confusion. The whole issue of health food supplements
and this over the counter type stuff, and these kids believe
that if you walk in a store and buy something in a bottle that
that makes it safe.
I think a lot of education on that aspect even, especially
if you are drinking something out of a bottle that is not
labeled and somebody gave you. That is a real clue. There might
be something in it that is not safe. I think education is
really critical.
Mr. Stupak. Is there any other precursor or common
ingredient in Ketamine that would make that easier to control
or track?
Ms. Porrata. No. Ketamine is all legally manufactured.
Mr. Stupak. Right.
Ms. Porrata. There is no illicit Ketamine. I think again
part of the problem with Ketamine misuse is an education thing.
It is mostly among the young kids, and it is used much like
crystal meth and stuff.
It is not a huge factor. It is not used a lot of times in
raves. I think it needs to be scheduled. It has legitimate
uses. It could be Schedule II, or Schedule III. Schedule II
means that the doctors have to track it a little more
carefully, and I think that is probably adequate for it.
Mr. Stupak. Ms. Porrata, you seem adamant that GHB should
be scheduled as a Schedule I drug. Why is that, and what effect
do you think such scheduling would have on companies like I
think it is Orphan Medical that currently has an
investigational new drug application pending with FDA?
Ms. Porrata. Well, first and foremost, it is a question of
the integrity of the drug scheduling concept. We have a system
by which drugs are supposed to be scheduled. It seems like we
are starting to piecemeal and we should avoid that. That is
part of the issue.
Second, there are no approved medical uses. I do not care
what Orphan Medical says. It has not been approved yet, has not
been substantially shown that it is safe. They are trying to
get the cart before the horse here by doing that.
I understand they are also opposed to Schedule II. Well,
even the legitimate Schedule II drugs that do have approved
medical uses, they have to struggle with the security issues.
They have to struggle with all the safety precautions. I do not
think there is any reason to say that one drug company and one
drug should be excluded from that type of security, but at this
point this is an extremely deadly drug.
I want to stress the issue is not the bathtub brew. The
issue is GHB. I do not care if it comes from a research lab.
GHB is what is dangerous and GBL by themselves, not the
potency. The potency adds an extra problem, and the addition of
the sodium hydroxide and the pH factor adds additional hazard,
but it is GHB that is dangerous. It is GHB that puts people in
comas and kills them. The other things are instrumental to
that.
We need to schedule it where it belongs. We need to then
let the proper process for research continue, and if and when
it is approved--I have talked to narcolepsy researchers who
admit that it will probably be several years before, in their
opinion, it is really a Schedule II drug. I just cannot
personally worry about drug companies, you know, and their
profits.
Mr. Stupak. In the GHB, some would say if we made it
Schedule I and II it is not the profits. It is the research
efforts because it is an orphan drug, which is a small amount
that is available for the research.
The application, as you indicated, may be limited, but do
you believe that research should continue as to see if there is
some legitimate uses of GHB?
Ms. Porrata. Oh, absolutely. I think the research should
continue, and I think it will. History has shown there are
other drugs that were in Schedule I. They were researched and
eventually changed. There is nothing that precludes that.
Obviously it makes it easier if it is not.
I think there has also been a lot of talk about well, if we
can get our foot in the door with this, you know, then it will
be easier. People can use it for more reasons if we can get it
approved. It is now opening the door.
We are trying to open Pandora's box here. Again, put it
where it belongs. Let us try to deal with it to the absolute,
most serious degree we can because this is a huge epidemic.
Then we will worry about that.
I think the research will continue. I think it is always
easy to say well, we are not going to touch it if it is
Schedule I. I do not think that is true.
Mr. Stupak. You indicate in your testimony, and let me
quote, that you were contacted by a man who said he was the
president of Orphan Medical and that you were amazed he could
not answer some very basic questions about this oh so safe drug
he was pushing so hard to protect.
What were the questions that you wanted him to answer that
he could not?
Ms. Porrata. I asked him some specific questions about some
of the effects that it has and some of the dangers, and one of
the questions was did he know what it does to brain waves,
especially on the research animals, but there is some question
whether it is in humans also. He did not even know what I was
talking about, so he did not seem to be terribly familiar with
the history of the research on this drug.
Dr. Winters, who researched this drug 30 years ago,
predicted this would be the most dangerous drug of abuse in the
world. Nobody really took him seriously at the time. It is not
really totally a central nervous system depressant. It actually
is considered also by some of the researchers as central
nervous system excitant. It puts the brain waves into epileptic
seizure mode in the research history.
Dr. McKay from UCLA also feels this way, that it is
actually a stimulant to the brain and that everything else
shuts down so we see it as a depressant, but it has some other
unique features to it that are pretty dangerous.
There is also a lot of talk about its research and use in
alcoholism. You know, all I can tell you is sure, an alcoholic
loves this because it does not have the hangover. You get drunk
without the hangover.
I think we are talking some very dangerous territory there
because it is a terribly impairing drug. These people can go
into a coma at 60 miles an hour. You can be driving down the
street at 60 and hit coma level. That is terribly, terribly
dangerous.
Mr. Stupak. In your testimony you were also concerned about
DEA's passivity, if I can say that, or being very passive when
you felt they should be on the cutting edge.
Having been in law enforcement and those of us in law
enforcement, we see these drugs come out. Unfortunately, we are
always reactive instead of proactive. Maybe Cat was the only
one we got a little ahead of the curve.
Can you tell me a little bit more about what you meant or
elaborate on DEA being passive and not quite active enough on
this?
Ms. Porrata. Well, there are a lot of agents and the
doctors who are involved in the research on this, some of the
chemists, who have been on top of it and known about this for a
long time, but we seem to get lost in the bureaucracy when it
goes to higher levels.
I think, and I have seen this at State level and some of
the medical boards and pharmacy boards where sometimes the
legislatures do not really use those people as resources to be
on the cutting edge. They do not ask them to be on the cutting
edge. In fact, their top officials sit around worrying about
well, we do not want to say too much because this guy might not
like it, and that might cause trouble.
Everyone is so worried about politics that people do not
speak out about what is right. As an agency even sometimes they
do not speak and say what needs to be said and let you then
handle that information. You need to task your agencies to be
on the cutting edge of this kind of stuff so that they can
provide leadership.
I do disagree a little bit on one issue. Yes, we need to
deal with the issues of rape and assault, but we must deal with
the specific drugs. What we need to do is find a way to
expedite these issues so that when a new drug does surface we
can control it. You cannot avoid controlling these and having
law enforcement handle it. We need to be able to expedite this
process. It should not take 5 or 6 years.
Today, because of the Internet and because of the
sophistication of these kids, kids meaning everyone up to 40 at
this point, we have to be far faster at dealing with this
stuff. They are out there systematically searching. If you go
to the Internet and go to these chat rooms, okay, if they take
GHB and GBL from us, what are we going to do next?
Mr. Stupak. Right.
Ms. Porrata. You know, we need to speed up this process to
where DEA is on top of it, they are allowed to be on top of it,
they are asked to be on top of it, and then you have a little
faster system to where we can address these things in a much
more rapid manner.
Mr. Stupak. Well, there is no doubt that we need to be more
rapid in it, in the synthetic drugs, taking legal substances to
make them illegal for an illegal use. Certainly as the Internet
and everything else expands, it is going to become more and
more of a problem.
I go back to Ephedrine being a legal substance which was
being used illegally to make the Cat, the Methcathadone that we
had. We were able to get in front of that curve.
Besides, DEA does have some emergency policies, and I am
going to ask them why they were not used, but the quickest way
that I know of to get a handle on this stuff is doing it this
way, is doing a legislative process.
That is why maybe at times I may have been a little
frustrated with it has been 2 years to get the hearing, so I
want to again close my questions by once again thanking my
friend from Michigan for providing the leadership to at least
get to the hearing stage.
I am sure after all your testimony we can move a little
faster and get this bill or combination of bills moved to the
floor.
With that, Mr. Chairman, thank you again. I will yield back
my time.
Mr. Upton. Thank you.
Witnesses, we appreciate your testimony and your indulgence
with us as we go through our normal day of votes. Your comments
are well taken. We look forward to working with the entire
community and moving something positive.
Thank you for telling your story. You are excused for
lunch.
Mr. Upton. We will have the next panel, Mr. Nicholas
Reuter, Associator Director of the Domestic and International
Drug Control of the Food and Drug Administration; Dr. Stephen
Zukin from the National Institute on Drug Abuse, National
Institutes of Health; Mr. Terrance Woodworth, Deputy Director
of the Office of Diversion Control for the Drug Enforcement
Agency; and Ms. Patricia Maher, Civil Division of the
Department of Justice.
Again, I appreciate you staying with us today obviously. As
you heard me explain to the earlier two panels, we do have a
long history of asking folks to have their testimony sworn in.
Do you have any objection to that?
[No response.]
Mr. Upton. We also allow, if you prefer, to have a counsel
with you. Do any of you prefer to have a counsel with you?
[No response.]
Mr. Upton. If not, if you would stand and raise your right
hand?
[Witnesses sworn.]
Mr. Upton. Thank you very much. You are now under oath. We
will begin with Ms. Maher. Again, if you can keep your comments
to 5 minutes, knowing that we will put your full statement into
the record, it would be appreciated.
TESTIMONY OF PATRICIA L. MAHER, CIVIL DIVISION, DEPARTMENT OF
JUSTICE; TERRANCE W. WOODWORTH, DEPUTY DIRECTOR, OFFICE OF
DIVERSION CONTROL, DRUG ENFORCEMENT ADMINISTRATION; NICHOLAS
REUTER, ASSOCIATE DIRECTOR, DOMESTIC AND INTERNATIONAL DRUG
CONTROL OFFICE OF HEALTH AFFAIRS, FOOD AND DRUG ADMINISTRATION;
AND STEPHEN ZUKIN, DIRECTOR, CLINICAL AND SERVICES RESEARCH,
NATIONAL INSTITUTE ON DRUG ABUSE, NATIONAL INSTITUTES OF HEALTH
Ms. Maher. Mr. Chairman and members of the subcommittee,
good morning. My name is Patricia Maher. I am a Deputy
Assistant Attorney General in the Civil Division of the
Department of Justice.
In that capacity I oversee the Office of Consumer
Litigation, the Civil Division's office that handles civil and
criminal cases brought under a number of Federal consumer
protection statutes, including the Federal Food, Drug and
Cosmetic Act.
At your invitation, I will speak to you about our
experience prosecuting traffickers of illegal drugs that are
used to get high and that over the last few years have been
used by perpetrators of sexual assault to incapacitate their
victims.
The substance with which the office of Consumer Litigation
has been most actively involved is gamma hydroxy butyrate or
GHB. GHB is not approved in this country for general consumer
use. Twenty-one States have made it a controlled substance, but
it is not a controlled substance under Federal law. It is
regulated as a drug under the Federal Food, Drug and Cosmetic
Act, and Federal prosecutions against distributors are brought
under that statute.
The emergence of GHB as a black market street drug can be
traced to convicted anabolic steroid dealer and amateur chemist
Mark Thierman in Tucson, Arizona. In 1989, Thierman devised a
formula for GHB, hired people to make it and began to sell GHB
throughout the country by mail order. Thierman sold hundreds of
thousands of dollars of GHB in powder form.
Although GHB was originally intended by Thierman and others
as a muscle building product, users found that the drug caused
euphoria, and it quickly developed a reputation as a widely
available way to get high.
GHB is made by combining two relatively common chemical
compounds, gamma butyrolactone or GBL, which is an industrial
solvent, and sodium hydroxide, commonly known as lye.
Shortly after GHB's discovery as a party drug, health
officials throughout the country began to receive reports of
serious adverse health effects associated with it, including
extreme vomiting, sudden and uncontrollable onset of sleep,
seizure like conditions and coma. On receipt of these reports,
in November, 1990, the FDA issued a warning to consumers
against use of the drug.
Subsequently, our Office of Consumer Litigation, in
conjunction with the U.S. Attorney's Office in Arizona,
investigated and indicted Thierman and his distributors for
felony violations of the Federal Food, Drug and Cosmetic Act.
Eleven defendants were ultimately convicted of charges,
including conspiracy, manufacturing and distributing misbranded
and adulterated drugs with the intent to defraud and mislead,
and operating an unregistered drug manufacturing facility with
the intent to defraud or mislead.
Starting in late 1992, however, GHB began to be used across
the country. Since 1992, GHB has bee responsible for numerous
deaths and numerous instances of drug facilitated sexual
assault.
A number of factors have contributed to the current
popularity of GHB. First, in 1992, Daniel Duchaine, a self
proclaimed steroid guru, published a book entitled The
Underground Steroid Handbook for Men and Woman, Update, 1992.
In it, Duchaine tells readers how to make a home brew for
liquid GHB.
Second, and even more insidiously, money hungry individuals
began to market GHB kits over the Internet. The kits provide
the purchaser with the ingredients and directions for making
the product in the home. The kits are sold to anyone, including
children, without any warnings about the extreme dangers
associated with both the manufacture and the use of the drug.
Not surprisingly, the number of deaths attributed to GHB has
increased since the recipe for this dangerous drug was made
widely available over the Internet.
Beginning in 1995, GHB was identified with perpetrators of
sexual assault. Typically the predator surreptitiously places
liquid GHB into the victim's drink. Within 20 minutes, the drug
can cause the victim to lose consciousness or to lose the
ability to control muscle function. The predator then sexually
assaults the victim.
In a few hours, the drug wears off, sometimes leaving the
victim with no memory of the event and with no trace of the
drug in his or her body, with no physical signs of forcible
assault. It is this pernicious aspect of GHB, the fleeting
nature of the evidence, that has made the identification and
prosecution of the predators who assault with GHB difficult.
The Civil Division's Office of Consumer Litigation has been
prosecuting traffickers of GHB for some time. We brought our
first GHB prosecution against Mark Thierman in 1992 and
obtained a sentence of 49 months' incarceration. We have
successfully prosecuted more than 30 individuals in 12
districts and have numerous pending cases.
In one particularly egregious case, an adult has been
charged with manufacturing and distributing GHB to underage
individuals and with the sexual assault of several young women.
We spearheaded a multi-district, multi-agency criminal
investigation of Internet GHB kit traffickers. Working with
Federal, State and local law enforcement agents, OCL
coordinated the execution of search warrants directed at the
largest kit distributors in four States. Those investigations
are ongoing. OCL attorneys have also provided substantial
assistance to local prosecutors and other law enforcement
authorities in a number of GHB related cases.
Recently we have encountered a GHB precursor product, gamma
butyrolactone or GBL, which becomes GHB in the body when it is
ingested. Although some GBL distributors have labeled their
product a dietary supplement, on January 21, 1999, the FDA
issued a public notice clarifying that GBL that was marketed
for human consumption is an illegally marketed, unapproved new
drug. A number of manufacturers have recently recalled GBL from
the market.
Attorneys from the Office of Consumer Litigation have been
active in the investigation and prosection of distributors of
these and other dangerous drugs.
The Office of Consumer Litigation, along with the Criminal
Division's Narcotics and Dangerous Drugs Section, have served
as a clearinghouse for prosecutorial information, which
includes helping local prosecutors prepare cases, distributing
information to State and Federal prosecutors and presenting
seminars on date rape drugs in forums such as the National
Association of Attorneys General, the National District
Attorneys Association and the National Association of
Prosecutor Coordinators.
Despite the steps taken by Federal and State law
enforcement and prosecuting offices, the availability of GHB,
GBL and other drugs involving them continues to grow. We remain
committed to finding and prosecuting the traffickers of these
drugs.
Thank you.
[The prepared statement of Patricia L. Maher follows:]
Prepared Statement of Patricia L. Maher, Deputy Assistant Attorney
General, Civil Division, Department of Justice
Mr. Chairman and Members of the Subcommittee: Good morning. My name
is Patricia L. Maher. I am a Deputy Assistant Attorney General in the
Civil Division of the Department of Justice. In that capacity, I
oversee the Office of Consumer Litigation (OCL)--the Civil Division's
office that handles civil and criminal cases brought under a number of
federal consumer protection statutes including the Federal Food, Drug,
and Cosmetic Act (FFDCA). This morning at your invitation, I will speak
to you about our experience prosecuting traffickers of illegal drugs
that are used to get high and that, over the last few years, have been
used by perpetrators of sexual assaults to incapacitate their victims.
At this time, I do not advocate any particular legislative action be
taken with respect to these drugs, but rather hope to inform you about
the Office of Consumer Litigation's efforts to combat this serious
problem.
The substance with which the Office of Consumer Litigation has been
most actively involved is gamma hydroxy butyrate or ``GHB,'' known on
the street as ``easy lay,'' ``liquid ecstasy,'' ``Georgia Home Boy,''
and ``scoop.'' GHB is not approved in this country for general consumer
use. Twenty States have made it a controlled substance, but it is not a
controlled substance under federal law. It is regulated as a ``drug''
under the FFDCA, and federal prosecutions against distributors are
brought under that statute. GHB was developed in the 1950's as a human
anaesthetic in Europe.
The emergence of GHB as a black-market street drug can be traced to
convicted anabolic steroid dealer and amateur chemist Mark Thierman in
Tucson, Arizona. In 1989, Thierman devised a formula for GHB, hired
people to make it, and began to sell GHB throughout the country by mail
order. Thierman sold hundreds of thousands of dollars of GHB in powder
form. Although GHB was originally intended by Thierman and others as a
muscle-building product, users found that the drug caused euphoria and
it quickly developed a reputation as a widely available way to get
high. GHB is made by combining two relatively common chemical
compounds: gamma butyrolactone (GBL), an industrial solvent, and sodium
hydroxide, commonly known as lye.
Shortly after GHB's discovery as a ``party'' drug, health officials
throughout the country began to receive reports of serious adverse
health effects associated with it, including extreme vomiting, sudden
and uncontrollable onset of sleep, seizure-like conditions, and coma.
On receipt of these reports, in November 1990, the FDA issued a warning
to consumers against use of the drug.
Subsequently, our Office of Consumer Litigation, in conjunction
with the U.S. Attorney's Office in Arizona, investigated and indicted
Thierman and his distributors for felony violations of the FFDCA.
Eleven defendants were ultimately convicted of charges including
conspiracy, manufacturing and distributing misbranded and adulterated
drugs with the intent to defraud and mislead, and operating an
unregistered drug manufacturing facility with the intent to defraud and
mislead.
Starting in late 1992, however, GHB began to be used across the
country. Since 1992 GHB has been responsible for numerous deaths and
numerous instances of drug-facilitated sexual assault. A number of
factors have contributed to the current popularity of GHB.
First, in 1992, Daniel Duchaine, a self proclaimed ``steroid
guru,'' published a book entitled the ``Underground Steroid Handbook
For Men And Women--Update: 1992.'' In it, Duchaine tells readers how to
make a ``home brew'' for liquid GHB. Second, and even more insidiously,
money hungry individuals began to market ``GHB kits'' over the
Internet. The kits provide the purchaser with the ingredients and
directions for making the product in the home. The kits are sold to
anyone, including children, without any warnings about the extreme
dangers associated with both the manufacture and use of the drug. One
illustrative case involved a GHB kit user who was admitted to an
emergency room in New York with burned lung tissue that was attributed
to aspiration of gastric contents containing GHB that had been made
with too much lye. Not surprisingly, the number of deaths attributed to
GHB has increased since the recipe for this dangerous drug was made
widely available over the Internet.
Beginning in 1995, GHB was identified with perpetrators of sexual
assault. Typically, the predator surreptitiously places liquid GHB into
the victim's drink. Within about 20 minutes, the drug can cause the
victim to lose consciousness or to lose the ability to control muscle
functions. The predator then sexually assaults the victim. In a few
hours, the drug wears off, sometimes leaving the victim with no memory
of the event, or with no trace of the drug in his or her body, or with
no physical signs of forcible assault. It is this pernicious aspect of
GHB--the fleeting nature of the evidence--that has made the
identification and prosecution of the predators who assault with GHB
difficult.
The Civil Division's Office of Consumer Litigation has been
prosecuting traffickers of GHB for some time. As noted above, we
brought our first GHB prosecution against Thierman in 1992 and obtained
a sentence of 49 months' incarceration. We have successfully prosecuted
more than thirty individuals in twelve districts and have numerous
pending cases. In one particularly egregious case, an adult has been
charged with manufacturing and distributing GHB to underage individuals
and with the sexual assault of several young women. We spearheaded a
multi-district, multi-agency criminal investigation of Internet GHB kit
traffickers. Working with federal, state and local law enforcement
agents, OCL coordinated the execution of search warrants directed at
the largest kit distributors in four states. Those investigations are
ongoing. OCL attorneys have also provided substantial assistance to
local prosecutors and other law enforcement authorities in a number of
GHB-related cases, including cases involving rape, homicide and
kidnaping.
Recently, we have encountered a GHB precursor product, gamma
butyrolactone (GBL), which becomes GHB in the body when it is ingested.
Although some GBL distributors have labeled their product a ``dietary
supplement,'' on January 21, 1999, the FDA issued a public notice
clarifying that GBL that was marketed for human consumption is an
``illegally marketed unapproved new drug.'' A number of manufacturers
have recently recalled GBL from the market.
In addition to GHB and GBL, I would also like to mention another
drug that has been used by perpetrators of sexual assault to facilitate
their crimes. It is an animal and human anaesthetic called ketamine
hydrochloride, known on the street as ``Special K,'' which has also
been used to get high and has been associated with drug-facilitated
rape. Traffickers of ketamine, a non-scheduled drug at the federal
level, could be prosecuted under the FFDCA. Ketamine has been made a
controlled substance in eighteen states.
Unlike GHB (which can be made at home), ketamine is only available
as a legitimate injectable product which is then diverted for street
use. Ketamine users typically snort the drug rather than inject it. The
recipe for converting the injectable liquid to powder is widely
available on the Internet and requires cooking and drying the liquid to
a solid and grinding the solid into a powder. Users claim that a mere
0.2 gram dose may induce a ``mellow, colorful wonder-world'' with a
feeling of being transformed into a robot, sometimes referred to as
``K-land.'' A 0.5 gram dose can produce ``out-of-body, near-death
experience,'' called a ``K-hole.'' Ketamine is extremely popular at
large music parties called ``raves'' where drug use can be abundant.
Attorneys from the Office of Consumer Litigation have been active
in the investigation and prosecution of distributors of these and other
dangerous drugs. For example, OCL recently worked with the U.S.
Attorney in Minnesota in obtaining an indictment charging a man with
raping two women after giving them zolpidem (trade name ``Ambien''), a
schedule IV controlled substance. Significantly, one of the victims was
15 at the time of the offense. This indictment was the first case in
the nation under the federal Drug Induced Rape Prevention and
Punishment Act.
The Office of Consumer Litigation along with the Criminal
Division's Narcotics and Dangerous Drugs Section have served as a
clearinghouse for prosecutorial information, which includes helping
local prosecutors prepare cases, distributing information to state and
federal prosecutors, and presenting seminars on date rape drugs in
forums such as the National Association of Attorneys General, the
National District Attorneys Association, and the National Association
of Prosecutor Coordinators.
Despite the steps taken by federal and state law enforcement and
prosecuting offices, the availability of GHB, GBL, and ketamine, and
the number of cases involving them continues to grow. We remain
committed to finding and prosecuting the traffickers in these drugs.
Thank you. I look forward to answering your questions.
Mr. Upton. Thank you very much.
Mr. Woodworth?
TESTIMONY OF TERRANCE W. WOODWORTH
Mr. Woodworth. Thank you, Mr. Chairman, for the opportunity
to appear before the subcommittee today on the subject of drugs
of abuse and their use in sexual assault cases. I will very
briefly provide you with DEA information on the three
substances that are the subject of today's hearing.
GHB is not currently a controlled substance and has no
accepted medical use in the United States. However, there is
extensive data demonstrating that it is being abused for its
psychoactive effects, and DEA believes it should be controlled
under the Controlled Substances Act.
As required by law, DEA is currently waiting for a
scientific and medical evaluation and a scheduling
recommendation from the Department of Health and Human Services
on GHB.
Among other reasons, GHB is abused for its ability to
produce euphoria, and its adverse side effects include
convulsions, severe respiratory depression and coma. GHB is
even more dangerous when used with alcohol. Medical examiners
have reported 32 fatalities since 1995 in which GHB was
detected, and in many of those deaths GHB was used in
combination with alcohol.
Drug Abuse Warning Network data indicates that estimated
emergency room episodes involving GHB increased from 54 in 1994
to 764 in 1997. On a national level, GHB related cases have
been documented by Federal, State and local law enforcement
officials in 41 States and the District of Columbia. In regard
to sexual assault cases, DEA is aware of at least 13 sexual
assault cases involving 22 victims under the influence of GHB.
The GHB encountered by law enforcement has all been
clandestinely manufactured. As you have heard, the manufacture
of GHB is a simple process requiring no special chemical
expertise. The primary precursor for GHB is gamma
butyrolactone, GBL, a readily available industrial chemical.
GBL plays a role in the GHB problem, and it will likely be
necessary to place some type of control on it after GHB is
controlled.
Flunitrazepam, commonly known as Rohypnol, belongs to the
benzodiazepine class of drugs and is abused by high school
students, college students, gang members, rave party attendees
and heroin and cocaine abusers. The drug produces profound
intoxication, boosts the high of heroin, modulates the effect
of cocaine. It is also commonly used in combination with
alcohol, which potentiates its toxic effects.
The DEA has documented approximately 4,500 Federal, State
and local law enforcement investigations involving the illegal
distribution and possession of Flunitrazepam in 38 different
States. The majority of these cases have been in Florida and
Texas.
The data from the Drug Abuse Warning Network includes 167
emergency room episodes involving Flunitrazepam from 1994
through 1997. Flunitrazepam has also been used to facilitate
sexual assault. Since 1994, DEA is aware of nine people who
have been convicted of sexual assault in which there was
evidence that Flunitrazepam was used to incapacitate the
victim.
Flunitrazepam was placed into Schedule IV of the Controlled
Substances Act back in 1984 due to international treaty
obligations. At that time, there was little abuse of
Flunitrazepam in the United States. More recently, with the
increase in trafficking and abuse, DEA began to consider the
merits of transferring Flunitrazepam into another schedule.
As the subcommittee is aware, HHS has recommended that
Flunitrazepam remain in Schedule IV. After considering the
relevant data and the HHS recommendation, DEA concluded that we
did not have sufficient grounds to justify administratively
rescheduling Flunitrazepam.
Ketamine. Ketamine is the only drug of these three
discussed that has been approved for marketing in the United
States. It is primarily used in veterinary medicine as a fast
acting, general anesthetic. The pharmacological profile is
essentially the same as Phencyclidine, PCP, which leaves the
individual anesthetized, detached or disconnected from their
pain and the environment. It has both analgesic and amnesic
effects.
As a drug of abuse, Ketamine has become common at rave
parties and is largely abused by teenagers and young adults. It
produces a dose related progression of effects from a state of
dreamy intoxication to delirium, accompanied by the inability
to move, feel pain or remember what has occurred while under
the drug's influence.
There has been no reported clandestine manufacture of
Ketamine to date, and it has been diverted primarily from
distributors and veterinarians. From 1993 to 1997, there were
145 emergency room episodes in DAWN. The DEA is aware of one
incident of rape.
The HHS has recommended on two occasions that Ketamine be
placed in Schedule III of the Controlled Substances Act based
largely on the pharmacological profile of the drug. On both
occasions, DEA determined that the incidence of actual abuse
was not sufficient to sustain the proposed scheduling action.
However, Ketamine's recent emergence as a drug of abuse
prompted DEA to request another evaluation by HHS in April
1998. They have already responded and again recommended that
Ketamine be placed in Schedule III. DEA will be publishing a
notice in the Federal Register very shortly.
In conclusion, Mr. Chairman, the DEA is on record and
continues to support rescheduling of Flunitrazepam and the
control of both GHB and Ketamine. These drugs are being abused
for their psychoactive effects and also used by rapists to
incapacitate their victims.
At least in the case of GHB, it may well be that
legislative action is the quickest way to achieve control
status. However, DEA is not opposed to congressional action in
regard to any of these substances.
I would like to thank the subcommittee for the opportunity
to offer DEA's comment.
[The prepared statement of Terence W. Woodworth follows:]
Prepared Statement of Terrance W. Woodworth, Deputy Director, Office of
Diversion Control, Drug Enforcement Administration
Mr. Chairman, distinguished members of the Committee, I want to
thank you for the opportunity to address you today on behalf of the
Drug Enforcement Administration (DEA) Administrator, Thomas A.
Constantine. I will provide you with some specific data on three drugs,
gamma-hydroxybutyrate (GHB), flunitrazepam and ketamine. Additionally,
I will discuss the GHB precursor, gamma-butyrolactone (GBL). While each
of these drugs has a unique chemical structure and specific
pharmacological properties, as drugs of abuse, they share a number of
similarities. Before I talk about each of these drugs individually, I
would like to take a few moments and comment about some of the things
they have in common.
Collectively, these three substances are referred to as ``party''
drugs because of their availability and distribution at bars, night
clubs and all-night dance parties called raves or techno parties.
Gamma-hydroxybutyrate (GHB, Goop), flunitrazepam (Roofies) and ketamine
(Special K) are new additions to a long list of substances that have
often been encountered in these settings. In the 1980s we saw the abuse
and trafficking of psychedelics like MDMA (Ecstasy) and its analogues
and the depressant, methaqualone (Ludes). Other drugs that are also
encountered in these settings include LSD (Acid), PCP (Angel Dust),
amphetamine, cocaine and marijuana. As their street names imply, these
drugs are touted to be fun. They have a wide range of pharmacological
effects and are often taken in combination with each other or with
alcohol. A disturbing factor is that these three substances are
primarily being abused by teens and young adults.
While the illicit trafficking and abuse of these substances are
DEA's primary considerations with regard to Federal control measures,
we are aware and concerned about the use of these substances to
facilitate the commission of sexual assault. As such, these three
substances are referred to as ``date rape'' drugs implying this more
sinister aspect of their illicit use. Individuals intent on sexual
assault are aware of the availability of these substances, especially
at bars and night clubs, and of their pharmacological profiles, both of
which provide some insight into why they might find these drugs so
appealing.
Each of these substances has gained popularity among drug abusers
in recent years. Since their emergence as drugs of abuse, the DEA has
been collecting data on their illicit manufacturing, distribution,
trafficking and abuse. I will provide you with a summary of that data.
Based on that data, the DEA now views these substances as having
significant abuse potential. There is evidence that individuals are
taking these substances in a manner and amounts sufficient to create a
hazard to their health or to the health and/or safety of others. There
is significant clandestine production of GHB and significant diversion
of the pharmaceutical products containing flunitrazepam and ketamine.
Large quantities of flunitrazepam have been illicitly smuggled into the
U.S. and ketamine has been diverted from legitimate veterinary supplies
within the U.S. Individuals are taking these substances on their own
initiative rather than on the advice of a medical practitioner.
Actually, only ketamine is approved for medical use in the U.S.--
neither GHB nor flunitrazepam has been approved for marketing as a
medicine by the Food and Drug Administration (FDA). In addition, these
substances share many of the same pharmacological properties of drugs
that have been identified as having serious abuse potential and are
already controlled in the Controlled Substances Act (CSA). This data
indicates that each of these drugs should be placed under control in
the CSA. At this time, however, only flunitrazepam is controlled at the
Federal level.
Although Congress has passed legislation that expedites the
scheduling of drugs and other substances under the CSA, the temporary
or emergency scheduling provision of the CSA could not be used for any
one of these three substances. Emergency scheduling action is not
possible when a substance is (1) being evaluated as part of a DHHS
approved research program as is the case with GHB; (2) already a
controlled substance as is the case with flunitrazepam; or (3) already
marketed in the United States as is the case with ketamine. As a
consequence, all three of these drugs have proven to be a challenge
with regard to more effectively controlling their abuse. Action to curb
the trafficking and diversion of these drugs has been difficult and
time consuming. Prior to changing the control status or placing any new
substance under control using administrative or traditional scheduling
process of the CSA, the DEA must gather the necessary data, forward
that information to the Department of Health and Human Services (DHHS)
and request, receive and consider a scientific and medical evaluation
from the DHHS. In addition, the CSA requires specific findings for each
of the five schedules that must be based on scientifically valid and
legally defensible data (See Attachment). Scheduling actions must be
substantiated by the available evidence. From the time the DEA
identifies a new drug of abuse to the time that substance is finally
placed under control in the CSA, if warranted, a significant amount of
time may elapse when the administrative scheduling process is utilized.
Gamma-hydroxybutyrate (GHB)
GHB is a central nervous system depressant which is abused for its
ability to produce euphoric states and its alleged role as a growth
hormone releasing agent to stimulate muscle growth. Although GHB gained
early favor with health enthusiasts as a safe and ``natural'' food
supplement sold in health food stores in the late 1980s, the medical
community soon became aware of overdoses and related problems caused by
its abuse. In 1990, the FDA issued an advisory declaring GHB unsafe and
illicit, except under FDA-approved, physician-supervised, study
protocols. GHB has not been approved by the FDA for marketing. Doctors
do not prescribe it, pharmacists do not sell it and patients do not use
it. However, it is currently under investigation for use in treating
narcolepsy under the FDA's Orphan Drug program.
Although its importation, distribution and use as a drug are not
allowed in the U.S., the abuse of GHB has increased. As a drug of
abuse, GHB is generally ingested orally after being mixed in a liquid.
The onset of action is rapid and in overdose, unconsciousness can occur
in as little as 15 minutes and profound coma can occur within 30 to 40
minutes. GHB produces dose-dependent drowsiness, dizziness, nausea,
amnesia, visual hallucinations, reduced blood pressure, decreased heart
rate, hypnotic effects resembling petit mal epilepsy, convulsions,
severe respiratory depression and coma. Overdose frequently requires
emergency room care, including intensive care for respiratory
depression and coma. Most individuals regain consciousness within two
to four hours. However, since 1995, Medical Examiners have reported 32
fatalities in which GHB was detected in the decedent. Many of these
deaths involved the use of GHB in combination with alcohol which
potentiates the depressant effect of GHB. Of these 32 cases, GHB was
found to be the sole cause of death in eight cases.
Since 1993, more than 3,500 GHB-related cases of abuse, overdose,
possession, illegal manufacturing, illicit diversion and trafficking
have been documented by Federal, state and local officials. This data
has been obtained from DEA case files, state and local law enforcement
case files, state and Federal forensic laboratory reports, the Drug
Abuse Warning Network (DAWN) data, the FDA Office of Criminal
Investigations and poison control center data bases. This data shows
that GHB is frequently taken in combination with other drugs that often
heighten its effects, and it is frequently found at bars, night clubs,
rave parties and gyms. The primary users are teenagers and young
adults. The populations abusing this drug fall into three major groups:
(1) users who take GHB as an intoxicant or euphoriant or for its
alleged hallucinogenic effects; (2) bodybuilders who abuse GHB for its
alleged utility as an anabolic agent or as a sleep aid; and (3)
individuals who use GHB to commit sexual assault. These categories are
not mutually exclusive and an abuser may use the drug illicitly to
produce several effects.
The number of cases in which GHB has been used facilitate sexual
assault is impossible to determine; many such cases may go unreported
or unsubstantiated due to the difficulty of detecting its use. GHB is
quickly eliminated from the body making detection in the body fluids
unlikely. In addition, GHB's fast onset of depressant effects and its
amnesiac effect render victims unable to recall the details of the
attack. Nonetheless, DEA is aware of 13 sexual assault cases involving
22 victims under the influence of GHB since 1996. These assaults
occurred in California, Florida, Louisiana, Maryland, Massachusetts,
Michigan, Texas, and Wisconsin.
GHB is illicitly produced in clandestine laboratories. Since 1997,
the DEA is aware of at least 100 cases involving GHB illicit
laboratories and over 200 submissions to DEA and state and local
forensic laboratories. GHB has been encountered in every region of the
United States and both small (personal use amounts) and large (intended
for distribution) clandestine laboratories have been encountered. It is
marketed as a ``legal high'' or a substitute for MDMA (Ecstasy) and is
sold in solid and liquid forms.
The clandestine synthesis involves the use of two common, non-
regulated chemicals: gamma-butyrolactone (GBL), the primary precursor
chemical, and sodium hydroxide (lye). The synthesis is a simple one-pot
method requiring no special chemical expertise. GBL is a solvent with a
wide range of industrial uses. Tens of thousands of metric tons are
produced annually and it is readily available from chemical supply
companies. In addition, kits for making GHB containing GBL and sodium
hydroxide are being sold on the Internet. GBL, once absorbed from the
gastrointestinal tract after oral administration, is readily converted
to GHB in the body and produces the same profile of physiological and
behavioral effects as GHB.
The DEA is reviewing various control measures for GBL. If GHB is
placed under Schedule I or II of the CSA, GBL could be treated as an
analogue for the purposes of criminal prosecution if it is being
distributed for human use outside of an FDA approved Investigational
New Drug (IND). As there are no regulatory controls imposed on handlers
of analogues, the licit industrial or pharmaceutical use of GBL would
be unencumbered by this method of control. Alternatively, if GHB is
controlled in any schedule of the CSA, GBL can be controlled as an
immediate precursor in the same or lower schedule as GHB. The full
range of CSA drug control measures would then apply to GBL. Another
method of controlling GBL distribution and use by clandestine
manufacturers would be to make GBL a listed chemical with a level of
control commensurate with its current industrial use. Both of these
last two measures (immediate precursor and listed chemical) could be
taken by the DEA following a notice and comment rulemaking process. In
October 1998, the DEA published a Federal Register notice seeking
information about the industrial uses and handling of GBL. The DEA is
currently evaluating this information.
The abuse of GHB is associated with significant adverse effects to
the abuser and health risk to the general public. The DAWN estimated
that there were 54 GHB emergency room mentions in 1994 compared to 764
in 1997. In 62 percent of these episodes, recreational use was cited as
the reason for taking this drug. Alcohol, which intensifies the
depressant and psychoactive effects of GHB, was reported in 86 percent
of the mentions. Poison control centers reported over 600 GHB incidents
in 1996 and over 900 GHB incidents in 1997. GHB is repeatedly detected
in driving under the influence (DUI) cases indicating the public health
and safety hazards associated with its abuse. As previously mentioned,
there have been 32 GHB-related deaths since 1995 and 22 GHB-related
sexual assaults reported to DEA since 1996.
Despite data indicating that the continued, uncontrolled
clandestine manufacture, distribution and abuse of GHB is an imminent
hazard to the public health and safety, the DEA cannot place GHB under
temporary control because it has an active IND exemption. As a
consequence, the DEA is pursuing measures to administratively schedule
GHB. In September 1997, the DEA forwarded its scheduling review to the
Department of Health and Human Services (DHHS) and requested their
scientific and medical evaluation and a scheduling recommendation. The
DEA continues to document law enforcement encounters and GHB-related
abuse cases and, as required by law, awaits a response from the DHHS
before proceeding with any proposed scheduling action. The DEA has also
conducted an informal field survey on GHB. Forty-one states and the
District of Columbia reported incidents involving GHB. Most of the
incidents reported in the survey occurred between January 1996 and
March 1998. Reports were received from hospitals, poison control
centers, coroners, police and sheriffs departments, public health
department laboratories, security departments of colleges and
universities and drug rehabilitation centers. Georgia, California and
Texas reported the highest number of incidents with 312, 237 and 223
reports, respectively.
Twenty states have already controlled GHB. Alabama, Delaware,
Georgia, Hawaii, Idaho, Illinois, Michigan, Nebraska, Nevada, Oklahoma,
Rhode Island, and Wisconsin have placed GHB in Schedule I. California,
Florida, Indiana, Louisiana and New Hampshire have placed it in
Schedule II and Alaska, North Carolina, and Tennessee have controlled
GHB in Schedule IV. In addition, New Jersey and Texas have criminalized
the sale and possession of GHB and placed it in the same penalty group
as LSD and marijuana.
Flunitrazepam
Flunitrazepam, commonly known as Rohypnol, belongs to the
benzodiazepine class of drugs. Like other benzodiazepines (such as
Valium, Librium, Xanax and Halcion), flunitrazepam's pharmacological
effects include sedation, muscle relaxation, reduction in anxiety and
prevention of convulsions. With respect to its sedative effects,
flunitrazepam is approximately 7 to 10 times more potent than diazepam
(Valium). The effects of flunitrazepam appear approximately 15 to 20
minutes after oral administration, and last approximately 4 to 6 hours.
Some residual effects can be found 12 hours or more after
administration. Although it is in Schedule IV of the CSA along with
other benzodiazepines (due to compliance with the Psychotropic
Convention), flunitrazepam has never been approved for medical use in
the United States. Doctors cannot prescribe it and pharmacists cannot
sell it. However, flunitrazepam is legally prescribed in over 50 other
countries, and is widely available in Mexico, Colombia and Europe where
it is used for the treatment of insomnia and as a preanesthetic
medication.
Flunitrazepam is abused by a wide variety of individuals including
high school students, college students, street gang members, rave party
attendees and heroin and cocaine abusers. It is abused to produce
profound intoxication, to boost the high of heroin, and to modulate the
effects of cocaine. Flunitrazepam is primarily abused orally and
frequently in combination with alcohol. To a much lesser extent, it is
also abused by crushing the tablets and snorting the powder.
Flunitrazepam causes anterograde amnesia in which individuals are
unable to remember certain events that they experienced while under the
influence of the drug. This anterograde amnesia is particularly
problematic when flunitrazepam is used to aid in the commission of
sexual assault; victims may not be able to clearly recall the assault,
the assailant, or the events surrounding the assault. Since 1994, at
least nine individuals have been convicted of sexual assault in five
state court cases in which there was evidence that they used
flunitrazepam to incapacitate the victim. The DEA is aware of 17 other
sexual assault cases from 1994 to 1998 in which there is evidence to
suggest that flunitrazepam was used to facilitate the assault.
For a variety of reasons, it is difficult to estimate just how
large a problem flunitrazepam-facilitated sexual assault is across the
country. One problem is the documentation of the use of flunitrazepam
in sexual assault cases. Very often in these cases, biological samples
are taken at a time when the effects of the drug have already passed
and only residual amounts remain in the body fluids. These residual
amounts are difficult, if not impossible, to detect using standard
screening tests available in the United States. If flunitrazepam
exposure is to be detected at all, urine samples must be collected
within 72 hours of ingestion and subjected to sensitive analytical
tests. The problem is compounded by the onset of amnesia after
ingestion, a factor on which the assailant relies to conceal the facts
surrounding the rape. This amnesiac effect may lead to critical delays
in reporting the assault, making it difficult or impossible to obtain
appropriate biological samples for toxicology testing.
The abuse of flunitrazepam, like other controlled substances, is
associated with clear risk to the abuser and to the safety of the
surrounding community. Flunitrazepam abuse causes a number of adverse
effects in the abuser, including drowsiness, dizziness, loss of motor
control, lack of coordination, slurred speech, confusion, and
gastrointestinal disturbances, which may last for 12 or more hours.
Higher doses produce respiratory depression. Chronic use of
flunitrazepam can result in physical dependence and the appearance of a
withdrawal syndrome when the drug is discontinued. Flunitrazepam
impairs cognitive and psychomotor function which affect reaction time
and driving skill. The use of flunitrazepam in combination with alcohol
is a particular concern because they both potentiate each other's toxic
effects. There were 167 flunitrazepam emergency room episodes reported
in DAWN from January 1994 through December 1997. Nearly half of the
episodes involved males under the age of 20. In nearly 50 percent of
the episodes drug dependence was reported as the motive for taking the
drug. Eighty percent of the episodes involved other drugs, including
alcohol (59%), marijuana (44%) and cocaine (35%).
The increased popularity of flunitrazepam has led to smuggling and
illegal distribution of flunitrazepam into various parts of the United
States. Flunitrazepam has most often been smuggled into the U.S. from
Mexico, primarily at border crossings located in Texas, Arizona and
California. In addition, approximately 25 other countries have been
identified from which flunitrazepam has been directly smuggled into the
U.S.
Since 1985, the DEA has documented approximately 4,500 Federal,
state and local law enforcement cases involving the illegal
distribution and/or possession of flunitrazepam in 38 states. The
largest number of cases in the past has been concentrated in Texas
(1,600) and Florida (1,500). Significant numbers of cases also occurred
in Louisiana, Oklahoma and Arizona with the majority of these cases
occurring between January 1994 and December 1996.
An examination of both DEA case files and the DEA System to
Retrieve Information from Drug Evidence reveals 212 cases involving
over 544,000 flunitrazepam tablets for the period of January 1, 1985 to
February 28, 1999. Most of these investigations were conducted in Texas
and Florida. There were 34,000 tablets of flunitrazepam seized in 1994,
227,199 tables seized in 1995, 155,000 tablets in 1996; and 35,000
seized in 1997. However, during 1998, the number of tablets seized
increased over the previous year with 56,000 tablets being seized. The
vast majority of these tablets were either the one milligram (mg)
pharmaceutical (Rohypnol) tablet or counterfeit two mg tablets which
contain flunitrazepam and are designed to look like the pharmaceutical
Rohypnol tablet.
The two mg pharmaceutical tablet, until recently, has been the most
frequently encountered form of flunitrazepam seized by law enforcement
officials. However, the manufacturer, Hoffman La Roche has discontinued
production of the two mg tablet. As a result, there was a significant
reduction in law enforcement encounters with the pharmaceutical two mg
tablets. This was followed quickly by increases in encounters with the
one mg pharmaceutical tablets and with counterfeit tablets containing
two mgs of flunitrazepam. Counterfeit tablets demonstrate that there is
an established illicit market in the U.S.
Flunitrazepam was placed into Schedule IV of the Controlled
Substances Act (CSA) in 1984 due to international treaty obligations.
At that time there was no known abuse of flunitrazepam in the United
States. However, over the last several years, DEA has been concerned
with the problem of flunitrazepam abuse and approximately four years
ago, began to consider the merits of transferring flunitrazepam to a
different schedule. While the abuse and trafficking of flunitrazepam
are considered to be an imminent hazard to the public safety, the DEA
could not take immediate steps to curb this abuse by using the
temporary scheduling provision of the CSA because this drug was already
a controlled substance. As a consequence, the DEA proceeded with the
administrative scheduling process and, as required under the CSA, the
DEA submitted its data on the abuse and trafficking of flunitrazepam to
the DHHS in April, 1996. Along with DEA's document was a request to the
DHHS for a scientific and medical evaluation and a scheduling
recommendation. In January, 1997, after the appropriate scientific and
medical review, the DHHS provided its scheduling recommendation to the
DEA which stated that flunitrazepam has no accepted medical use in the
United States (consistent with Schedule I placement) but that its abuse
potential was no different than other benzodiazepines, a finding which
is consistent with Schedule IV control. The DHHS recommended that
flunitrazepam remain in Schedule IV. After careful analysis of the
relevant data and in consideration of the DHHS recommendation, the DEA
concluded that sufficient grounds did not exist to administratively
reschedule flunitrazepam. Several states, however, have determined that
the existing controls were inadequate to address the abuse and
trafficking of flunitrazepam within their jurisdictions and have
rescheduled flunitrazepam through their state administrative process or
by state legislation. Florida, Idaho, Minnesota, New Hampshire, New
Mexico, North Dakota, Oklahoma, and Pennsylvania have rescheduled
flunitrazepam into Schedule I and some states have increased the
penalties for illegal distribution.
Even though the control status of flunitrazepam has not changed,
other actions have been taken. Congress passed The Drug-Induced Rape
Prevention and Punishment Act of 1996 which made it a crime to give any
unconsenting individual a controlled substance with the intent of
committing a violent act, including rape, against that individual. In
addition, the law established stricter Federal penalties for the
possession and distribution of flunitrazepam without changing the
schedule of the drug. In implementing these new penalty provisions, the
United States Sentencing Commission established sentencing guidelines
for flunitrazepam that were above those generally applicable to
Schedule I and II depressant drugs. These guidelines became effective
on November 1, 1997. Also, since March 5, 1996, the U.S. Customs
Service has been seizing personal use amounts of flunitrazepam
encountered at border points of entry. This action was taken in
response to the growing abuse and trafficking problem and the fact that
it is not approved for use in this country.
Ketamine
The final drug I would like to discuss is ketamine. It is the only
one of the three which has been approved for marketing in the United
States although its primary use is in veterinary medicine. It is a
rapidly acting, general anesthetic whose pharmacological profile is
essentially the same as phencyclidine (PCP). Like PCP, individuals
anesthetized with ketamine feel detached or disconnected from their
pain and environment. In addition, ketamine has both analgesic (pain
relief) and amnesic (memory loss) properties. The use of ketamine as a
general anesthetic for humans has been quite limited due to its adverse
effects including the delirium and hallucinations which some experience
after awakening from anesthesia. However, it does have some utility for
emergency surgery in humans and surgery of short duration in children
and the elderly, groups which experience delirium and hallucinations
less frequently.
As a drug of abuse, ketamine (street name ``Special K'') has become
common at dance parties or ``raves.'' It produces a dose-related
progression of effects from a state of dreamy intoxication to delirium
accompanied by the inability to move, feel pain or remember what has
occurred while under the drug's influence. The ``Special K'' trip is
similar to that of LSD or PCP but lasts only 30 to 60 minutes as
opposed to several hours. Ketamine is less potent than PCP: 25 mg of
PCP can produce a full psychedelic experience whereas it would require
at least 100 mg of ketamine (depending on body size) for a similar
effect.
``Special K'' is prepared by evaporating the liquid from the
legitimate pharmaceutical injectable product and grinding the residue
into a powder. Ketamine is difficult to synthesize and there have been
no reports of its clandestine manufacture. All of the ketamine
encountered by law enforcement to date has been diverted from licit
sources, primarily distributors and veterinarians. The ``Special K''
powder is snorted like cocaine or to a lesser extent smoked on tobacco
or marijuana. In addition, the liquid form has been added to drinks. A
typical dose would be 20 mgs snorted in each nostril, repeated at 5 to
10 minute intervals (usually 3 or 4 times) until the desired effect is
achieved. It is distributed as powder in small bottles, ziplock bags,
capsules, paper, glassine or aluminum ``folds'', or as a liquid in
small vials or bottles.
Prior to 1993, there were few documented law enforcement
encounters, emergency room mentions, or reported thefts of ketamine.
However, since 1993, the frequency of law enforcement encounters as
well as emergency room and medical examiner's reports has increased,
indicating the increased abuse of ketamine. Abuse of ketamine is
indicated in the 145 emergency room episodes reported to DAWN during
the period 1993 to 1997. Alcohol, cocaine and marijuana were the most
frequently reported substances identified in the DAWN reports as being
used in combination with ketamine. This drug can be used by individuals
intent on committing sexual assault due to its effect on victims who
become extremely compliant and later may not be able to remember what
happened. However, the DEA is aware of only one documented case in
which it was demonstrated that ketamine was used to facilitate a rape.
Of course, the same factors which could lead to the under-reporting of
the use of flunitrazepam and GHB in sexual assault apply to ketamine as
well.
The DHHS has, on two occasions, in 1981 and 1986, recommended that
ketamine be placed in Schedule III of the Controlled Substances Act
(CSA) based on a scientific and medical review. These recommendations
were based largely on the pharmacological profile of the drug. On each
occasion, the DEA determined that the incidence of actual abuse, along
with its status as a prescription drug with limited distribution, did
not provide sufficient cause to place ketamine under CSA control.
Ketamine's recent emergence as a drug of abuse has prompted the DEA to
reevaluate its placement in the CSA. The DEA requested a new scientific
and medical evaluation and scheduling recommendation from DHHS in April
1998. The DHHS conducted an expeditious review and responded to our
request in December 1998. The DHHS again recommended Schedule III
placement. The Federal control of ketamine is proceeding and a notice
of proposed scheduling should be published within 60 days.
Eighteen states have already controlled ketamine: California,
Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana,
Louisiana, New Hampshire, New Jersey, New Mexico, New York, Oklahoma,
and Wisconsin have placed it in Schedule III; Missouri and Tennessee
have placed it in Schedule IV; and Massachusetts has placed ketamine
under the same penalty category as LSD and PCP.
Conclusion
GHB, flunitrazepam and ketamine are three recent drugs of abuse.
Their continued illegal distribution and abuse pose serious risks to
the American public health and safety. In reviewing the data presented
here today, it is clear that GHB and ketamine should be placed under
control in the CSA and that the actions taken to deter flunitrazepam
smuggling and illegal distribution and abuse must be continued. The DEA
applauds the actions taken by various states authorities to quickly
address the abuse, diversion and trafficking of these substances in
their areas. Such actions are also part of the evaluation process for
Federal control of these drugs when warranted. Emergency scheduling
action to increase the regulatory controls and curb the illicit
availability and abuse of certain substances is not possible when those
substances are: (1) already controlled [flunitrazepam]; (2) already
marketed in the U.S.[ketamine]; or (3) are being evaluated as part of a
DHHS approved research program [GHB]. We are working within the
Executive Branch with DHHS to examine alternatives to current
procedures.
The continued abuse and trafficking of GHB are of grave concern to
the DEA. Congress may legislatively place any of these substances under
the CSA and the DEA would not be apposed to Congress taking this action
especially in regard to GHB. Congress has taken similar action in the
past. It directed that methaqualone be moved from Schedule II to
Schedule I in 1984 and it added anabolic steroids to Schedule III in
1990.
Mr. Chairman, in closing, I would like to thank you and the
Committee for providing me with the opportunity to offer the DEA's
position and comments on the very serious problem of abuse of GHB,
flunitrazepam and ketamine. I will be happy to answer any questions you
may have.
findings required to place a substance in schedules i-v as set out in
21 u.s.c. 812(b)
Schedule I:
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted medical
use in treatment in the United States.
(C) There is a lack of accepted safety for use of the drug or other
substance under medical supervision.
Schedule II:
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted use in
treatment in the United States or a currently accepted medical use with
severe restrictions.
(C) Abuse of the drug or other substance may lead to severe
psychological or physical dependence.
Schedule III:
(A) The drug or other substance has a potential for abuse less than
the drugs or other substances on schedules I and II.
(B) The drug or other substance has a currently accepted medical
use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to moderate or
low physical dependence or high psychological dependence.
Schedule IV:
(A) The drug or other substance has a low potential for abuse
relative to the drugs or other substances in schedule III.
(B) The drug or other substance has a currently accepted medical
use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited
physical dependence or psychological dependence relative to the drugs
or other substances in schedule III.
Schedule V:
(A) The drug or other substance has a low potential for abuse
relative to the drugs or other substances in schedule IV.
(B) The drug or other substance has a currently accepted medical
use in treatment in the United States
(C) Abuse of the drug or other substance may lead to limited
physical dependence or psychological dependence relative to the drugs
or other substances in schedule IV.
Mr. Upton. We thank you for being here as well.
Mr. is it Reuter or Reuter?
Mr. Reuter. It is Reuter----
Mr. Upton. Reuter.
Mr. Reuter. [continuing] from the news agency.
Mr. Upton. So I had it right.
Mr. Reuter. I answer to Reuter as well.
Mr. Upton. All right. Thank you. Thank you for coming.
TESTIMONY OF NICHOLAS REUTER
Mr. Reuter. Thank you. My name is Nick Reuter, and, Mr.
Chairman, members of the committee, thank you for the
opportunity to testify on the role of the Food and Drug
Administration in the scheduling of drugs under the Controlled
Substances Act. We recognize and share your interest and
concern in this matter.
Before we begin, we wish to express our sympathy with all
those affected, especially the families of the young women
involved in the tragic incidents in Michigan and Texas. These
types of incidents certainly highlight the problems with the
use of illicit substances.
You have asked us today to focus on FDA's role in the
scheduling process and to specifically discuss three drug
substances of interest to the committee. As requested, I will
restrict my oral comments to 5 minutes and ask that my full
written statement be included in the record.
The primary role of FDA under the CSA is to provide the
Secretary of Health and Human Services with our scientific and
medical evaluation of drugs. FDA's consultative role stems from
the provisions of the CSA. This role is consistent with FDA's
mission of public health protection.
Under this act, the Secretary is charged with evaluating
certain medical and scientific factors and making
recommendations to the Attorney General as to whether the
substance under review should be managed as a controlled
substance or removed from control and the appropriate level of
control.
The CSA establishes the factors and findings determinative
for control. The eight factors set forth in this law allow the
Attorney General, and by delegation the Drug Enforcement
Administration, to schedule a drug if she finds that the drug
has a potential for abuse that warrants control.
The Attorney General must also take into account whether
the drug has a currently accepted medical use within the U.S.
and the extent to which the use of the drug may lead to
physical or psychological dependence. The Attorney General also
must request from the Secretary of DHHS a scientific and
medical evaluation of the drug and make a recommendation as to
whether the drug should be controlled and, if so, under what
schedule.
After evaluating the eight factors, the Secretary must make
a scheduling recommendation. The Secretary of HHS has delegated
the responsibility for this recommendation to the Assistant
Secretary for Health, who relies on FDA and NIDA to develop the
medical and scientific evaluation and consider the appropriate
factors and scheduling criteria, which are all set forth in the
law.
These evaluations and recommendations are unique to the
drug in question and are based on the substance's relative
abuse potential, its medical usefulness and its capacity to
produce dependence. Upon completion, the medical and scientific
evaluation and scheduling recommendation of FDA and NIDA are
forwarded to the ASH, who makes the final determination on
behalf of the Secretary.
The medical and scientific evaluation and the
recommendation as to the appropriate schedule for the drug are
then forwarded to the Drug Enforcement Administration. I would
refer you to my written statement for details on the importance
of the Department's mandated scientific and medical review
under the Controlled Substances Act.
A detailed discussion of the three drugs, GHB, Ketamine and
Rohypnol, you asked FDA to address are contained in my written
statement as well. Given the time, I will not discuss those in
great detail.
I would like to discuss the effort of FDA, and particularly
FDA's Office of Criminal Investigations, to address the abuse
of GHB. It is important to stress this because FDA is not only
reviewing drugs for control under the Controlled Substances
Act, but we are also enforcing provisions of the Food, Drug and
Cosmetic Act.
Indeed, the Office of Criminal Investigations has initiated
aggressive enforcement actions against the manufacture and
interstate distribution of GHB. These initiatives are directed
at large scale interstate manufacturers and distributors,
including Internet website vendors as we saw this morning.
Working with the Office of Chief Counsel and FDA's Center
for Drug Evaluation and Research, OCI has developed
investigation and prosecution strategies that have been highly
effective in identifying and convicting violators.
Also, OCI and the Center for Drugs within FDA and the
Department of Justice have developed and maintained a list of
scientific experts available to testify in court proceedings.
OCI also uses its expertise and resources to assist State and
local police departments in conducting numerous investigations.
As part of our systematic efforts to combat the abuse of
GHB, FDA's Office of Criminal Investigations has initiated and
supported a number of Federal and State prosecutions throughout
the U.S. related to the illegal manufacture and distribution of
the drug.
To date, the Government has obtained over 33 GHB related
convictions nationwide, and it really does not stop there. Our
technical and investigative assistance is invaluable to the
approximately 20 States that have enacted legislation to make
GHB a controlled substance. We have held a number of training
seminars for Federal, State and local enforcement
administration agencies.
Let me conclude by saying that drug control evaluations and
recommendations under this CSA can be complex. They definitely
require the balancing of more than one public health interest.
FDA would agree that there is a critical need to protect
the public health from the dangers posed by drugs and
substances of abuse. At the same time, we have to recognize
that many drugs that have the potential for abuse may also be
medically beneficial, and a large segment of the population
might benefit from the optimization of drug development. These
interests sometimes create tension in this scheduling process.
In FDA's dual role as the evaluator of products that
promote public health and the evaluator of substances that
present a danger to the public, we will use the best available
scientific data to make the speediest and best decisions.
We are committed to optimizing our interactions with our
critical partners, Federal, State and local officials,
scientific, the clinical and industrial community. There is no
question that FDA needs to move quickly to assist in the
evaluation of these drugs and substances so that scheduling
under the CSA can move forward.
I want to thank the committee and the chairman for the
opportunity to testify, and I will be glad to answer questions.
[The prepared statement of Nicholas Reuter follows:]
Prepared Statement of Nicholas Reuter, MPH, Associate Director for
Domestic and International Drug Control, Office of Health Affairs, Food
and Drug Administration, Department of Health and Human Services
Mr. Chairman, thank you for the opportunity to testify on the role
of the Food and Drug Administration (FDA or Agency) in the scheduling
of drugs under the Controlled Substances Act (CSA), 21 U.S.C. Sec. 811.
We recognize and share your interest and concern in this matter and
before we begin, we wish to express our sympathy with all those
affected, especially the families of the two young women involved in
the tragic incident in Michigan. These types of incidents certainly
highlight the problems with the use of illicit substances. You have
asked us today to focus on FDA's role in the scheduling process and to
specifically discuss three drug substances of interest to the
Committee.
fda role
The primary role for FDA under the CSA is to provide the Secretary
of the Department of Health and Human Service (DHHS) with our
scientific and medical evaluation of drugs. FDA's consultative role
stems from the provisions of the Comprehensive Drug Abuse Prevention
and Control Act (Act) of 1970. Pub. L. 91-512 (October 27, 1970). Such
a role is consistent with FDA's mission of public health protection.
Under the Act, the Secretary of DHHS is charged with evaluating certain
medical and scientific factors and making recommendations to the
Attorney General as to whether the substance under review should be
managed as a controlled substance, or removed from control, and the
appropriate level of control. Title II of the Act, now fully
incorporated into the CSA, establishes the factors and findings
determinative for control. The factors set forth under 21 U.S.C.
Sec. 811 allow the Attorney General and, by delegation, the Drug
Enforcement Administration (DEA), to schedule a drug if she finds that
the drug has a potential for abuse. The Attorney General also must take
into account whether the drug has a currently accepted medical use
within the United States and the extent to which the use of the drug
may lead to physical or psychological dependence.
When evaluating a particular drug, the Attorney General must, under
21 U.S.C. Sec. 811 (c), consider the following factors:
(1) Its actual or relative potential for abuse. (2) Scientific
evidence of its pharmacological effect, if known. (3) The state
of current scientific knowledge regarding the drug or other
substance. (4) Its history or current pattern of abuse. (5) The
scope, duration, and significance of abuse. (6) What, if any,
risk there is to the public health. (7) Its psychic or
physiological dependence liability. (8) Whether the substance
is an immediate precursor of a substance already controlled
under this title.
Before proceeding to control a drug under this process, the
Attorney General also must request from the Secretary of DHHS a
scientific and medical evaluation of the drug and make a recommendation
as to whether the drug should be controlled and, if so, under what
schedule. In making such a recommendation, the Secretary of DHHS must
take into consideration factors (2), (3), (6), (7) and (8) and any
scientific and medical considerations involved in factors (1), (4) and
(5) as described above.
After evaluating the eight factors, the Secretary must make a
scheduling recommendation based on the substance's relative potential
for abuse, its accepted medical use and its capacity for producing
physical and psychological dependence. Under the CSA, substances in
Schedule I have a high potential for abuse and no accepted medical use.
Substances in Schedule II have a high potential for abuse but do have
an accepted medical use. Substances in Schedules III-V have an accepted
medical use and a relatively lower potential for abuse.
The legislative history of the CSA is replete with hearings,
discussion and statements that the scientific and medical evaluation of
DHHS is important and critical to the process. The operative provisions
of the CSA reflect that history. In particular, 21 U.S.C. Sec. 811(b)
states:
The recommendation of the Secretary to the Attorney General
shall be binding on the Attorney General as to such scientific
and medical matters, and if the Secretary recommends that a
drug or other substance not be controlled, the Attorney General
shall not control the drug or other substance.
The Secretary of DHHS has delegated responsibility for DHHS's
recommendation to the Assistant Secretary of Health (ASH). The ASH, in
turn, relies on FDA and the National Institute on Drug Abuse (NIDA) to
develop the medical and scientific evaluation and consider the
appropriate factors and scheduling criteria. Under an interagency
Memorandum of Understanding (MOU), FDA and NIDA cooperate in completing
the medical review, evaluation, and recommendation that DHHS conducts
as part of the domestic drug scheduling process.1
---------------------------------------------------------------------------
\1\ Memorandum of Understanding With the National Institute on Drug
Abuse and the FDA, March 3, 1985 (50 FR 9518)
---------------------------------------------------------------------------
Proceedings to add, delete or change the schedule of a drug or
other substance may be initiated by DHHS, DEA or by petition from any
interested person such as a drug manufacturer, medical society,
pharmacy association, public interest group or state and local
government. Typically, FDA will not begin its medical and scientific
evaluation until it receives, through the ASH, a formal request for
such an evaluation from DEA. FDA may also initiate such an evaluation.
FDA typically will do so during the investigational stages of drug
development or at such time that an application to market a new drug is
received by FDA and the Agency believes that the substance may be a
candidate for scheduling under the CSA as provided for in 21 U.S.C.
Sec. 811(f) which states:
If, at the time a new drug application is submitted to the
Secretary for any drug having a stimulant, depressant, or
hallucinogenic effect on the central nervous system, it appears
that such drug has an abuse potential, such information shall
be forwarded by the Secretary to the Attorney General.
process within fda
The scientific and medical evaluation process is a complex one
which is a part of the balancing of the interests of various agencies.
There is a critical need to protect the public from the dangers posed
by drugs and substances of abuse. At the same time, we recognize that
many drugs that have the potential for abuse also may be medically
beneficial and a large segment of the population might benefit from the
optimization of drug development. These interests can create a tension
in the scheduling process.
The FDA Office of Health Affairs (OHA) is responsible for the
coordination of the DHHS activities in preparation of the report and
recommendation on scheduling. Internally, once a scheduling request is
referred to FDA, there is a review period during which FDA's Center for
Drug Evaluation and Research (CDER), with assistance from others within
the Agency, conducts a review of the drug. The data review includes
review of the chemical properties, pharmacology studies and clinical
studies and reports related to the drug.
This evaluation involves the careful analysis of many kinds of
data: data on chemical synthesis and solubility; data on absorption and
metabolism; information gathered from studies designed to investigate
whether animals develop physical dependence and will work to self-
administer the drug; and, whether an animal can distinguish a given
drug from other controlled substances. Interaction studies with other
agents, including alcohol, also may be evaluated. Human adverse events
(relating to the drug's ability to cause physical dependence, alter
moods, cause hallucinations, etc.) are collected and reviewed from
clinical trial reports and from postmarketing experience if applicable.
In the case of a new drug under investigation, the data specific to
the issue of abuse potential may not already be developed by the
sponsor unless there has been some reason to suspect that it may indeed
have abuse potential. These kinds of specialized studies are not a
routine aspect of the drug development process. The development of this
information, therefore, may take many years as studies are initiated
and completed and as more clinical trial experience becomes available.
FDA has an Advisory Committee, composed of non-FDA employees,
available if necessary, to review the data and provide recommendations
to FDA concerning the medical and scientific evaluation, abuse
potential and the need for scheduling controls. The CDER Division will
then forward a recommendation for review by CDER's Center Director.
Once the recommendation is signed by the Center Director, it is
reviewed by the Office of Commissioner, including OHA. The
recommendation is then forwarded for formal interagency review, a
process coordinated by OHA.
During this period, there are informal consultations with NIDA.
Under the MOU, FDA transmits the scheduling request from DEA upon
receipt from DHHS to NIDA for concurrent review. An interagency group,
the Interagency Drug Scheduling Working Group (IDSWG), which includes
representatives from FDA, NIDA and the Substance Abuse and Mental
Health Services Administration (SAMHSA), convenes periodically to
assess the status of the scheduling review. Occasionally, the IDSWG
will identify the need for additional abuse liability testing, or, on
rare occasions, a public hearing under Part 15 of FDA regulations.
The MOU, noted above, describes procedures for sharing information
between the agencies, and outlines FDA's role in preparing the initial
recommendation and eight factor ``basis'' document. Upon completion,
the medical and scientific evaluation and scheduling recommendation of
FDA and NIDA are forwarded to the ASH who makes the final determination
on behalf of the Secretary. The medical and scientific evaluation and
the recommendation as to the appropriate schedule for the drug are then
forwarded to the DEA.
Since the inception of the scheduling process in 1970, there have
been dozens of substances reviewed for control under the CSA. On
average, DHHS completes its response to a scheduling request within 8-
10 months. In addition, FDA, DEA and NIDA meet monthly to discuss
issues of mutual concern in the drug abuse control area. The
Interagency Committee on Drug Control, formed in the early 1970s,
provides a forum to discuss emerging drug issues and monitor the status
of ongoing activities within the agencies.
It should be noted that there are other scheduling mechanisms that
I will not discuss in detail but I do want to mention. Many substances
were controlled under the CSA at the time the law was enacted in 1970.
Scheduling also can be accomplished by legislation. The scheduling of
Methaqualone (Qualuudes) and anabolic steroids are examples of
legislative control. In addition, there is scheduling to fulfill treaty
obligations. Finally, DEA can ``emergency'' schedule certain substances
not subject to an investigational new drug application, under certain
conditions on a temporary basis if there is an imminent hazard to the
public health. 21 U.S.C. Sec. 811(h)(1).
Ketamine, Rohypnol (Flunitrazepam) and GHB (Gamma-Hydroxybutyrate)
There are three drugs you requested that we specifically discuss in
our testimony, Ketamine, Rohypnol and GHB. These drugs have been the
subject of abuse in varying degrees for a number of years.
Ketamine--Ketamine is an anesthetic and has been approved both for
human and animal use as an anesthetic. It was approved both as a human
and veterinary drug in 1970. Ketamine has powerful analgesic and
amnesic actions in humans and is typically used in humans in pediatric
and obstetric procedures and is prominently used in veterinary
procedures. Approximately 90% of the Ketamine legally sold today is for
veterinary use. In the 1980s, Ketamine emerged as a recreational street
drug because consumption of large doses cause reactions similar to
those associated with use of PCP. Symptoms associated with recreational
use of ketamine include dream-like states and hallucinations. The Drug
Abuse Warning Network (DAWN) documented at least two Ketamine related
deaths between 1993 and 1997 in which no other drugs, including
alcohol, were used.
DHHS has evaluated Ketamine three times pursuant to requests from
DEA for a medical and scientific evaluation and has forwarded a
scheduling recommendation each time. The first time was in 1981; the
second in 1986 and recently in 1998. Each time a recommendation was
made to DEA from DHHS that Ketamine be placed in Schedule III of the
CSA. Each time a request for a recommendation was made, FDA had to
review current medical and scientific data to ensure that the Schedule
III recommendation was appropriate. To date these recommendations have
not been finalized.
Rohypnol--Rohypnol (flunitrazepam) is an unapproved drug in the
United States, although it is approved in Europe and is used in over 60
countries. The drug belongs to the class of drugs known as
benzodiazepines (such as Valium, Halcion, Xanax, and Versed ) and is
used outside the United States as a treatment for relief of insomnia,
to induce sedation and as a pre-anesthetic. The drug can cause
anterograde amnesia, thus, individuals may not remember certain events
they experienced while under the effects of the drug. This effect is
presumably what has lead to the drug's use in sexual assaults. Without
the ability to recall the sexual assault or rape, the victim is
hindered in assisting law enforcement officials in providing
information leading to the prosecution of the perpetrator. For these
reasons, one of the street names for Rohypnol is ``the forget me
pill.'' The drug is tasteless, odorless and dissolves easily in
carbonated beverages.2 The sedative and toxic effects of
Rohypnol also are aggravated by the concurrent use of alcohol. Even
without alcohol, doses as small as 1 milligram can incapacitate a
victim for 8-12 hours.
---------------------------------------------------------------------------
\2\ It should be noted that the drug manufacturer, located in
Ireland, has indicated that efforts are underway to change the
solubility of the drugs and to introduce a coloring to the drug that
will appear when dissolved.
---------------------------------------------------------------------------
Rohypnol is not approved or available for medical use in the United
States, but it is temporarily controlled in Schedule IV pursuant to a
treaty obligation under the 1971 Convention on Psychotropic Substances.
At the time flunitrazepam was placed temporarily in Schedule IV
(November 5, 1984), there was no evidence of abuse or trafficking of
the drug in the United States.
In March 1996, DEA requested that DHHS conduct a scientific and
medical evaluation and provide a permanent scheduling recommendation
for Rohypnol. DHHS provided a recommendation to DEA in January 1997
that it remain in Schedule IV. This action has not been finalized.
FDA continues to work with the United States Customs Service
(Customs) and DEA to control the illegal importation of Rohypnol into
the United States through smuggling from other countries. FDA issued an
import bulletin in December 1995 and the Agency continues to work to
help control the illegal entry of the drug.
GHB--GHB is an unapproved drug in the United States and currently
is not scheduled under the CSA. It is approved in other countries for
use as an anesthetic in humans. The drug is a central nervous system
depressant that can induce deep sleep. GHB is presently the subject of
several investigational new drug applications (IND) and is being
studied for commercial development in the United States. FDA designated
GHB as an orphan drug in 1987 for the treatment of patients with
narcolepsy and the constellation of symptoms of cataplexy, sleep
paralysis, hypnagogic hallucinations and automatic behavior. FDA also
has issued orphan product grants for the study of GHB in the treatment
of narcolepsy. Orphan Medical, Inc., has submitted an IND to FDA to
review the use of GHB in the diagnosis and /or treatment of narcolepsy.
At the same time, GHB also is being abused as an intoxicant,
depressant, euphoriant, growth hormone releasing agent and as an agent
in sexual assaults. Unlike the two drugs discussed above, GHB poses a
particularly acute law enforcement problem in that it can be easily
synthesized by individuals with a limited knowledge of chemistry. Gamma
Butyrolactone (GBL) and Sodium Hydroxide are the chemicals necessary to
make GHB. Both of these chemicals are readily purchased from numerous
chemical supply houses. Also, the recipe to manufacture the drug can be
obtained easily over the Internet.
FDA has been involved in evaluating the reports of abuse of GHB and
investigating the adverse events suffered as a result of the abuses.
Since it was established in 1992, FDA's Office of Criminal
Investigations (OCI) has tried to take aggressive enforcement actions
against the manufacture and interstate distribution of GHB. OCI's
investigative initiatives are directed at large scale interstate
manufacturers and distributors including Internet web site vendors.
Working with the Office of Chief Counsel and CDER, OCI has developed
investigative and prosecution strategies that have been highly
effective in identifying and convicting violators. From 1993 until the
present, OCI has worked closely with CDER and FDA's National Forensic
Chemistry Center to develop an expertise in the safe handling and
processing of GHB when collected as evidence. Also, OCI, CDER and the
Department of Justice have developed and maintained a list of
scientific experts available to testify in court proceedings. OCI also
utilizes its expertise and resources to assist state and local police
departments in conducting numerous investigations. As a part of our
systemic efforts to combat abuse of GHB, FDA/OCI has initiated and
supported a number of federal and state prosecutions throughout the
United States related to the illegal manufacture and distribution of
the drug. To date the government has obtained over 33 GHB-related
convictions nationwide.
Our technical and investigative assistance is invaluable to the
approximately 20 states that have enacted legislation to make GHB a
controlled substance. In March 1997, the OCI San Diego Field Office
conducted a training seminar for federal, state and local law
enforcement agencies who were responsible for controlling the rapid
growth in the use and abuse of GHB in Southern California. In July
1997, OCI continued to assist state and local law enforcement efforts
when its San Francisco Resident Office conducted a GHB training seminar
for law enforcement personnel in Northern California.
OCI also has responded to a request from DEA's Office of Drug
Diversion, Drug and Chemical Evaluation for all available information
related to the synthesis, tracking, usage and other illicit commerce
involving GHB. The recent surge in the popularity of GHB and its
precursors (GBL or 1, 4 butanediol) has made combating its illegal use
increasingly difficult. Investigations are resource intensive and the
laws used to prosecute distribution under the Federal Food Drug and
Cosmetic Act are relatively complex.
FDA has issued several alerts and warnings concerning GHB. FDA also
has worked with Customs to stop the importation of GHB and in May 1992,
FDA issued an Import Alert providing for automatic detention of the
product.
Most recently, FDA moved to alert consumers not to purchase or
consume products, some of which are labeled as dietary supplements,
that contain GBL. When taken orally, GBL is converted in the body to
GHB. FDA pressed the companies that manufacture these products to cease
the manufacture and distribution of these products and to voluntarily
recall them. As of this date, all of the manufacturers that were
contacted agreed to cease the manufacture and distribution of their
GBL-containing products. All but one has agreed to recall the products.
The Agency had received reports of serious health problems--some that
are potentially life-threatening--associated with the use of these
products. Although some of these products were labeled as dietary
supplements, the products were, and are, illegally marketed unapproved
new drugs. They are promoted with fantastic and unsubstantiated claims
to build muscles, improve physical performance, enhance sex, reduce
stress and induce sleep.
GBL related products have been associated with reports to FDA of at
least 55 adverse health events, including one death. In 19 cases, the
individuals became unconscious or comatose and several required
intubation for assisted breathing. Other reported effects included
seizures, vomiting, slow breathing and slow heart rate. There have been
reports of at least five children under 18 years of age who have been
injured or who have suffered these kinds of effects.
As a result of the increased abuse of GHB, DEA requested in
September 1997 that DHHS conduct a scientific and medical evaluation of
GHB and submit a scheduling recommendation for GHB. In response to
DEA's request, the Department has continued to gather and evaluate
scientific data on GHB's potential for abuse. These activities have
proceeded in conjunction with the OCI enforcement actions and the
ongoing clinical investigation of GHB for the treatment of narcolepsy.
In December 1998, FDA determined that the sponsor could provide GHB
under a treatment IND. Once under a treatment IND, the product may then
be legally prescribed to appropriate patients before general marketing
is allowed. Treatment INDs are a means of facilitating, even before
general marketing of the product, the availability of promising new
drugs to desperately ill patients for whom no other therapy is
available. FDA approves treatment INDs if there is preliminary or
presumptive evidence of drug efficacy and the drug is intended to treat
a serious or life-threatening disease, or if there is no comparable
alternative drug or therapy available to treat that stage of the
disease in the intended patient population. The drug also must be
considered safe for its intended use under a physician's care. Patients
who receive the drug under the treatment IND are not eligible to be in
the definitive clinical trials, which must be well underway, if not
almost finished. These ongoing investigations may allow FDA to learn
more about GHB's relative potential for abuse, to aid in the scheduling
review and to develop additional information for the product labeling.
FDA is completing its evaluation and recommendation on GHB to DHHS.
As part of the review, the Agency is determining if GHB's abuse
potential is ``high'' relative to substances controlled currently in
Schedules I and II (such as heroin, PCP, LSD, marijuana, etc.) or if
its abuse potential is closer to anabolic steroids or benzodiazepines,
currently controlled in Schedule III and IV.
conclusion
Increasingly, our citizens have had to face the increasing
availability and abuse of drugs and other substances. In FDA's dual
role as the evaluator of products that promote public health and
evaluator of substances that present a danger to the public, we will
use the best available scientific data to make the speediest and best
decisions. We are committed to optimizing our interactions with our
critical partners--federal, state and local officials, scientific,
clinical and industrial. There is no question that FDA needs to move
quickly to assist in the evaluation of these drugs and substances so
that scheduling under the CSA can move forward.
Thank you for the opportunity to testify.
Mr. Upton. Thank you very much.
Dr. Zukin?
TESTIMONY OF STEPHEN ZUKIN
Mr. Zukin. Mr. Chairman and members of the subcommittee, I
am grateful for this opportunity to testify.
I am the Director of the Division of Clinical and Services
Research at the National Institute on Drug Abuse, which is the
research institute at the National Institutes of Health
responsible for supporting research in the health aspect of
drug abuse and addiction.
I will provide you with a brief overview of what science
has shown concerning gamma hydroxy butyrate. Although GHB will
be the main focus of my attention today, I will be happy to
answer questions about Ketamine or Rohypnol or other drugs.
As you heard from earlier panels, GHB is one of a number of
drugs reportedly being used to sedate women to facilitate
sexual assault. Many of the drugs discussed today, including
GHB, are predominantly central nervous system depressants which
relax or sedate the body.
GHB is a naturally occurring compound which is found in the
brain. Research suggests that GHB itself may act as a
neurotransmitter. However, more research needs to be conducted
to determine the true psychological function of GHB.
The predominant effects of GHB are sedative, though GHB can
produce a wide range of pharmacological effects, depending upon
the dose. At lower doses, GHB can relieve anxiety and produce
relaxation. However, as the dose increases, the sedative
effects result in sleep, then seizures and eventually coma or
death.
Research also shows that GHB increases dopamine levels in
the brain. This is relevant because we have come to believe
that the ability to increase brain dopamine levels is a common
characteristic of most drugs of abuse.
GHB has also been found to stimulate the release of growth
hormone. Plasma levels of growth hormone rise quickly and
steadily after administration of GHB, which probably accounts
for the popularity of GHB among body builders.
The existing scientific data makes it difficult to
determine with precision the abuse liability of GHB. Abuse
liability is a composite term used to assess the likelihood of
a drug's abuse potential through evaluation of its
pharmacological and behavioral effects and review of its actual
abuse and consequences.
Animal studies suggest that GHB may be reinforcing. For
example, when rats are given a choice between water and a
solution containing GHB, they tend to prefer the GHB and appear
to regulate their intake to maintain a constant GHB
concentration in the body. Primate studies, however, are more
ambiguous. Some primates will self administer GHB, but not all,
and not to the same extent as other drugs such as heroin or
cocaine.
There have been very few clinical studies conducted on GHB
abuse in humans. However, there have been reports that GHB
causes both tolerance and dependence in human subjects.
Research has shown that GHB's effects are usually seen ten to
20 minutes from the time the drug is taken. The effects
typically last up to 4 hours, depending on the dosage. Low
doses can sedate an individual, whereas high doses can be
lethal. The drug's relatively short half-life makes it
difficult to detect in emergency rooms and other such
facilities.
GHB is relatively easy to make from common ingredients with
recipes available on the Internet and in underground
literature. The chief ingredient used to make GHB is gamma
butyrolactone or GBL, which is converted by the body into GHB.
GBL is used in a number of dietary supplements found in health
food stores and health clubs.
The fact that GHB is relatively easy to make may be one of
the reasons why a number of monitoring mechanisms are
suggesting that GHB use is increasing. For example, NIDA's own
Community Epidemiology Work Group is seeing increases,
particularly among young adults who attend raves or private
clubs. Poison control centers have documented numerous cases of
acute poisonings associated with GHB.
According to the Drug Abuse Warning Network or DAWN, there
has been a significant increase in the number of emergency room
mentions associated with GHB. The number has grown from one in
1991 to 629 in 1996. The DAWN medical examiner's report shows
that there has been one GHB related death in combination with
alcohol reported between 1992 and 1995. However, the Drug
Enforcement Administration has documented 32 deaths associated
with GHB, some of which were attributed to GHB alone.
In conclusion, NIDA and the Department remain concerned
about the harmful effects of GHB. Therefore, NIDA will continue
to support research that examines the behavioral and
pharmacological mechanisms of action and the relative abuse
liability of drugs such as GHB.
We will share this information, as well as information
gleaned through our surveillance systems, with the general
public and policymakers to insure that everyone has the most
current and accurate information that science has to offer.
Thank you again for the opportunity to testify.
[The prepared statement of Stephen Zukin follows:]
Prepared Statement of Stephen Zukin, Director, Division of Clinical and
Services Research, National Institute on Drug Abuse, National
Institutes of Health
Mr. Chairman and Members of the Subcommittee, I am Dr. Stephen
Zukin, Director of the Division of Clinical and Services Research at
the National Institute on Drug Abuse (NIDA), one of the research
institutes at the National Institutes of Health. I am here today with
my colleagues to present what the science has come to show about drugs
such as ketamine, rohypnol and gamma hydroxybutyrate (GHB), drugs that
are reportedly being used in sexual assault incidents.
Gamma hydroxybutyrate (GHB) is the drug that I will focus much of
my discussion on today, though I will be pleased to answer questions
about the other drugs as well. GHB is one of a number of drugs that
have been reported to be used as a ``date rape'' drug. These drugs are
predominantly central nervous system (CNS) depressants. Because these
drugs are often colorless, tasteless and odorless, they can be easily
added to beverages by individuals who want to intoxicate or sedate
their victims.
There is some evidence that GHB is a naturally occurring compound
found in the brain. Research suggests that GHB itself may be a
neurotransmitter. Brain receptor sites have been reported, as well as
brain mechanisms for synthesis, release and uptake of GHB. GHB has been
found to be related to the brain's major inhibitory neurotransmitter,
GABA. There is also some evidence that the brain has the ability to
convert GHB into GABA. However, more research needs to be conducted to
determine the true physiological function of GHB.
The predominant effects of GHB are sedative, though GHB can produce
a wide range of pharmacological effects depending on the dose. At lower
doses GHB can relieve anxiety and produce relaxation. However, as the
dose increases, the sedative effects result in sleep and eventual coma
or death.
Research also shows that GHB increases dopamine levels in the
striatum of the brain. Dopamine is a neurotransmitter that is
intimately involved in reward and pleasure. We have come to believe
that the ability to increase brain dopamine levels is a common
characteristic of most drugs of abuse.
GHB also stimulates the release of growth hormone from the anterior
pituitary gland. Plasma levels of growth hormones rise quickly and
steadily after administration of GHB, which probably accounts for the
popularity of GHB among some bodybuilders.
From the existing preclinical and clinical scientific data it is
difficult to determine with precision the ``abuse liability'' of GHB.
Abuse liability determinations, simply put, assess pharmacological and
behavioral effects of drugs relative to known drugs of abuse, as well
as their consequences. It is a way for scientists to assess the
likelihood that a drug will be abused. Factors such as the reinforcing
appetitive effects that the drug has on the individual, the possible
physical dependence that may develop from using the drug, and the
potential consequences associated with use of the drugs, are considered
in the abuse liability determination.
Animal research has confirmed that GHB is anxiety-reducing and
sedating. Other animal studies suggest that GHB may be reinforcing in
self-administration studies. For example, rats given a choice between
water and a solution containing GHB prefer the GHB and appear to
regulate their intake to maintain a constant GHB concentration in the
body. Self-administration studies of GHB in primates are more
equivocal, primarily because high dose evaluations are limited due to
solubility difficulties and sedation of the animals. However, some
primates will also self-administer GHB but not to the same extent as
other drugs such as heroin or cocaine.
There have been relatively few human or clinical studies conducted
on GHB. Investigators report that some individuals experience pleasure
after taking the drug. GHB's intoxicating effects are usually seen 10-
20 minutes from the time the drug is taken. The effects typically last
up to four hours, depending on the dosage. The behavioral and
physiological effects of GHB are dose dependent. Low doses can relax an
individual, whereas high doses can be lethal. The drug has a relatively
short half-life, making it difficult to detect in emergency rooms and
other such facilities.
Tolerance, and as I mentioned earlier physical dependence, are also
factors used to determine a drug's abuse liability. Both tolerance to
GHB's euphoric and sedative effects and physical dependence have been
reported. These properties may contribute to continued abuse. Case
studies describe the illicit purchase of GHB for abuse of its sedative,
euphorigenic, and anabolic effects and also that some users tend to
escalate doses. Physical dependence is evidenced by a withdrawal
syndrome characterized by insomnia, muscle cramps, tremor and anxiety
when GHB is discontinued. Various sources describe instances of dose
escalation, compulsive use, unsuccessful efforts by individuals to
decrease or discontinue use, drug-seeking, and continued use despite
adverse consequences.
The available data on the actual abuse of GHB and its associated
consequences is largely anecdotal. GHB is usually abused either (1) for
its intoxicating/sedative/euphoriant properties or (2) for its growth
hormone releasing effects.
GHB was widely available over the counter in health food stores
during the 1980s, purchased largely by body builders for its ability to
stimulate release of human growth hormone, which aids in fat reduction
and muscle building. GHB has not been sold over-the-counter in the
United States since 1992. However, products containing gamma
butyrolactone (GBL), a chemical that is converted by the body into GHB,
are used in a number of dietary supplements in health food stores and
gymnasiums. GHB is still being marketed in Europe as a general
anesthetic, a treatment for insomnia and narcolepsy, an aid to
childbirth, and as a treatment for alcoholism.
GHB is relatively easy to make from common ingredients with recipes
available on the Internet and in underground literature. GHB is now a
popular drug with the young adults who attend ``raves'' or private
clubs. An advance report from NIDA's Community Epidemiology Work Group
(CEWG), a network of epidemiologists and researchers from 21 major U.S.
metropolitan areas who meet semiannually to monitor community-level
trends in drug use and abuse, found that GHB was used at ``raves'' in
Miami, Minneapolis/St. Paul and Seattle. Overall, of the 21 areas
included in the CEWG Report, 10 areas reported increased incidences of
GHB use.
Poison Control Centers have documented numerous cases of acute
poisonings associated with GHB. Initial symptoms of acute GHB toxicity
include vomiting, drowsiness, dream-like state, decreased muscle tone,
and vertigo. Loss of consciousness, irregular and depressed
respiration, tremors, or myoclonus sometimes followed. Seizures,
bradycardia, hypertension, and/or respiratory arrest have also been
reported. Symptom severity and durations of action are dose dependent
and also relate to the absence or presence of other CNS depressants.
The only systematic reporting of harm associated with GHB abuse is
the data from the Drug Abuse Warning Network (DAWN), which is a
surveillance system run by our colleagues at the Substance Abuse and
Mental Health Services Administration. The number of emergency room
(ER) mentions associated with GHB has grown from one in 1991 to 629 in
1996 for a total of 892 GHB-related ER mentions. Most of the reports
involve white males. 95% of the patients are between the ages of 18-34.
Most were using GHB to receive its pleasurable effects. GHB was abused
most often in combination with other drugs, usually with alcohol, but
also with stimulants, hallucinogens, marijuana, and sedatives. Most
DAWN ER reports were from San Francisco, Dallas, Los Angeles, San
Diego, and Atlanta.
The DAWN Medical Examiners have reported one GHB-related death in
combination with alcohol between 1992-1995, occurring in 1995 in the
Midwest. However, the Drug Enforcement Agency (DEA) has documented 32
deaths associated with GHB (4-attributed to GHB alone).
Another drug that the Subcommittee asked us to address is ketamine.
Ketamine is also reportedly being used as a ``date rape'' drug.
Ketamine is a rapid-acting general anaesthetic. It has sedative-
hypnotic, analgesic, and hallucinogenic properties and is marketed in
the United States and a number of foreign countries for use as a
general anesthetic in both human and veterinary medical practice.
Ketamine is similar to phencyclidine (PCP), although ketamine is more
rapid in onset and less potent. We have quite a bit of information on
this particular drug, which we would be happy to provide if that would
be helpful to the members.
Given that the Food and Drug Administration has included
information on Rohypnol in their testimony, I will not address this
drug in my formal statement. I will be happy to provide additional
information if it would be useful.
The Role of the Department of Health and Human Services
As the government's principal agency for protecting the health of
all Americans, the Department of Health and Human Services is involved
in making recommendations on domestic scheduling of drugs of abuse.
Once the Attorney General initiates a scheduling proceeding, a request
is made to the Secretary of HHS to provide a scientific and medical
evaluation of the drug and a recommendation as to whether the drug
should be controlled domestically. The Food and Drug Administration
takes the lead role in gathering data from relevant HHS agencies.
As the world's leading research institute on drug abuse and
addiction, NIDA has a memorandum of understanding with FDA (Memorandum
of Understanding With the National Institute on Drug Abuse and the FDA,
March 3, 1985 (50 FR 9518)) to provide expertise to the FDA in
investigating and evaluating the abuse liability of drugs.
NIDA advises the FDA on the Department's ``Eight Factor Analysis.''
The factors taken into consideration in evaluations and recommendations
for each substance under consideration include: Its actual or relative
potential for abuse; Scientific evidence of its pharmacological
effects; The state of current science regarding the substance; Its
history and current pattern of abuse; The scope, duration and
significance of abuse; What, if any risk there is to the public health;
Its psychic or physiological dependence liability; Whether the
substance is an immediate precursor of a substance already controlled.
Conclusion
In conclusion, as a protector of the public's health, the
Department realizes the harmful effects that drugs like GHB can have.
That is why NIDA continues to support research on all drugs of abuse.
In particular, NIDA will continue to support research that examines the
behavioral and pharmacological mechanisms of action and relative abuse
liability of drugs like GHB and Ketamine. We will share this
information with our federal colleagues to ensure the best available
science informs important decisions, such as scheduling, which impact
the overall health of our Nation. We will also disseminate this
information to the general public and policy makers to ensure that they
also have the most current and accurate information about the effects
of these drugs. Information that we retrieve through NIDA's drug
monitoring mechanisms, particularly NIDA's Community Epidemiological
Work Group (CEWG) will also be useful in alerting us to emerging drug
problems. This information will also be shared as expeditiously as
possible.
Thank you for the opportunity to testify before this Subcommittee.
Mr. Upton. We thank all of you for testifying.
As you heard those buzzers, that means we are called again.
We have a series of votes, two votes, and I think what we will
do is reconvene at 1:30 p.m. Sorry about that. We will come
back at 1:30 p.m.
[Brief recess.]
Mr. Upton. I do not think we will be interrupted again
unless we go a long time. We have a couple hours before the
next vote.
We thank you for your testimony, and we will proceed with
the 5 minute rule for the members that come back. Again, I
apologize for the members that are not here as there are a
number of subcommittee marks and hearings all over the place,
so we will be having members come in and out.
I guess, from my perspective when I first heard about the
case in Michigan and asked myself and my staff what are we
doing to prevent drugs like these from getting out particularly
to young girls like we heard testify here. Ms. Pruett, was age
15 when she was raped, as was another 15-year-old in Michigan.
I noticed in some press clips from Michigan, I guess this
was from the Detroit News, an Ecorse High School date rape
fight goes to the schools. I talked to some of my
superintendents in my district when I was back last week about
it as well.
The bottom line for me, and I am not a lawyer. I am not a
scientist. I am not an engineer. I am not a lot of things, but
I am interested in the bottom line. Whether it is a piece of
legislation or whether it is an agency rule or regulation to
try to restrict something. It seems to me to make sense that we
ought to take it.
As I heard the testimony from the first two panels,
including Ms. Sheila Jackson-Lee, who, like me, was impacted by
a death of a young woman in her district and as I talked to
other members who have had the same type of experience in their
States and as we assembled this panel, I just want to know what
else is there that we need to know about this, to know that
this is a bad drug, that it ought to be banned somehow, some
way?
As I listen to the testimony of you four, and I have read
it at length as well, I end up with that same question. I just
wonder. Is there any more evidence that we need to submit? I
guess I am going to make a little bit of a rambling statement,
but then I would like you all to comment.
As I read, Dr. Reuter, your testimony where it says on page
6 that on average DHHS completes its response to a scheduling
request within eight to 10 months, and I read the testimony
from the DEA and others, Dr. Zukin's folks as well, that the
request had been I think originally to schedule this, you know,
somewhere along the line I, II, even III or IV, even as early
as September 1997. If you add it up, that is what, 18 or 20
months. I mean, we are twice as long as what the average
timeframe is.
Is there something else that we need? Do we need to proceed
with legislation to get the job done? Can we do this
administratively so we do not need that, though certainly I am
prepared to speak and encourage my colleagues to co-sponsor
such legislation and begin to move it through the process and
see where we are in the Senate, as well as where we are in the
House? What else do we need to do?
Maybe, Mr. Woodworth, if you want to comment on that and
Dr. Zukin? I do not know if there is any more evidence. Then,
Mr. Reuter, maybe you can respond. Has all your evidence been
submitted? Have you been asked for anything else to provide?
Mr. Woodworth. The normal process is that once we have done
our piece, we forward it to the Secretary of Health. Once it is
returned, then we will complete some further analysis because
we continue to collect data during the interim, so we are
continuing to collect data with regard to GHB.
Mr. Upton. Okay. So the ball is not in your court is what
you are saying at the moment?
Mr. Woodworth. At this time.
Mr. Upton. Okay. Dr. Zukin?
Mr. Zukin. Well, I think----
Mr. Upton. If you could use the mike?
Mr. Zukin. Yes.
Mr. Upton. I can hear okay, but I am not sure everybody
else can. It is for the stenographer here, too.
Mr. Zukin. Under our memorandum of understanding with FDA,
FDA does take the lead, as indicated in their testimony.
Perhaps Mr. Reuter could also respond.
In other words, when FDA forwards a copy of their final
recommendation to us, at that point we officially become
involved in the process in terms of whether we concur with the
FDA recommendation or not and so forth.
Of course, there has been extensive staff discussion
between NIDA and FDA through this process, but we have not yet
seen their final recommendation.
Mr. Upton. Mr. Reuter?
Mr. Reuter. Yes. You talked a little bit about the language
in the written testimony about the length of time, eight to 10
months, ten to 12 months. It might be good to understand a
little bit about why sometimes----
Mr. Upton. Sorry. You are not saved by the bell this time.
You have to finish.
Mr. Reuter. [continuing] in carrying out these scientific
and medical evaluations under the CSA, which is the law that
controls us here, how sometimes it is difficult to find the
appropriate level of control for a substance.
What is it about GHB? First of all, it is a drug that is
under development for medical use and, you know, that balancing
act they talked about a little bit this morning, the medical
need versus the need to protect the public from these
substances that pose a danger.
It is easily manufactured clandestinely with ingredients
that have extensive industrial uses, which presents a bit of a
complication. There is a specific subculture that appears to
abuse these drugs more than one other group, and there is a
sense that scheduling itself might not solve the problem.
I mean, with Rohypnol we had an interagency effort with
Customs, with DEA, with FDA. There were States involved. All
these things taken together call out for an expansive,
coordinated Federal role.
I would say that we take this problem very seriously. We
are moving to expedite the review within HHS for the scheduling
recommendation on this substance.
Mr. Upton. Just a last quick question, and then I will
yield to Mr. Stupak.
As we were over on the floor today on these last votes, one
of our first questions any member asks is what time are we
going to be done today. Are we going to be done by 7 p.m.? Are
we going to be done by 10 p.m.? Are we going to be in tomorrow
with votes? When do we get to go back?
Do you have a sense as to when a final recommendation is
going to be made? Is it going to be made in the spring? Is it
going to be made, you know, at Easter? Is there some sense in
terms of when the timing is in terms of a final decision being
made in terms of Schedule I, II, III or IV? Next year?
I am a Cubs fan. You know, we all say next year, although I
hope it will be this year.
Mr. Reuter. I am an Oriole fan, and we are looking at the
year after.
We are actively working on the recommendation, and I can
tell you that it will be soon. It will be forwarded very soon.
Mr. Upton. But you cannot be better? You know, if we ask
when are we going to out of session, soon, that is not good
enough. Do we know? Spring? Fall? Do you have any better sense
of----
Mr. Reuter. I wish I could. It is still under very active
deliberation, and it really would be premature and
inappropriate to pick a specific date or even a general date.
I guess it would surprise me if it went past next year. I
mean, at the outset that would be well beyond the pale. It is
under active investigation. We are taking it very, very
seriously.
Mr. Upton. So you would not mind then if the Congress moved
ahead with a piece of legislation then? You would not object to
us moving ahead with legislation along the lines of Ms. Sheila
Jackson-Lee or Bart Stupak, my colleague, or other folks?
Mr. Reuter. I think along with all the other panelists
here, we are looking for ways to optimize the process. DEA had
some language in their testimony about what might be an
appropriate way to expedite control.
We participated in a technical assistance endeavor last
fall. You know we are committed. We are willing. We are ready
to work with the committee to move this along.
Mr. Upton. Mr. Stupak?
Mr. Stupak. Thank you, Mr. Chairman.
Have you looked at any of the legislation, either my
legislation or the Jackson-Lee legislation, from a technical
point of view, Mr. Reuter, to suggest if it could be approved
or it should be approved?
Mr. Reuter. We have not carefully studied it. It has not
been submitted for formal review. You know, just in glancing at
it in the package this morning, you can see differences.
Mr. Stupak. Sure.
Mr. Reuter. We have recommended Ketamine for Schedule III,
but legislation appears to place it in a different schedule.
No, we do not have formal views to offer on it at this time.
Mr. Stupak. My concern is it has been a long time. If I am
reading your testimony correct, it says since it was
established in 1992, FDA's Office of Criminal Investigations
has tried to take aggressive enforcement actions against the
manufacture and interstate distribution of GHB. That is found
on page 10 of your statement.
It is now 1999. This is just going on and on and on, and I
can understand some frustration with FDA and others. Why is it
taking so long to do this?
You know, this first came to my attention in 1996, early
1997. We put some bills in to try to address it. When we did
the Families First Juvenile Justice bill we tacked it in there.
Then we did a freestanding bill because it is a very pressing
problem. I am just concerned that we continue to push back that
time line. Nothing is being done.
When can we expect some action? Fred was being polite. Soon
is not a good enough answer.
Mr. Reuter. Unfortunately, that is the best answer I can
give, Mr. Stupak.
I tried to explain a little bit about the balancing we need
to do and the weighing of factors and how GHB presents these
kind of unique situations on a case by case basis that we have
to take into consideration.
Mr. Stupak. But it seems we have been balancing since 1992.
Can we get some commitment to get technical assistance on any
type of legislation then that we would propose?
Mr. Reuter. Yes. I think I mentioned earlier that we are
ready to work with Congress to move this along as best we can.
We provided technical assistance on legislative matters in the
past, and we are willing to work with you to move it along.
Mr. Stupak. Okay. Let me go to some other questions.
In the 20 or 21 States that have GHB, how do they have it
scheduled, Schedule I, Schedule II, Schedule III or Schedule IV
or V? Do you know?
Mr. Reuter. Well----
Mr. Stupak. Does anyone know, any one of you? Mr.
Woodworth?
Mr. Woodworth. There are 20 States, I believe, as far as
DEA information, that control GHB.
Mr. Stupak. Right.
Mr. Woodworth. Twelve States control it in Schedule I,
including Michigan.
Mr. Stupak. Right.
Mr. Woodworth. If you would like the names of those, I can
give them to you.
Five States control GHB in Schedule II, no one schedules it
in III, and three States, Alaska, North Carolina and Tennessee,
have put it in Schedule IV. Three other States, Texas, New
Jersey and Massachusetts, have criminalized activity.
Mr. Stupak. Thank you. So only three States have
criminalized it?
Mr. Woodworth. Yes, sir.
Mr. Stupak. Okay. Go ahead.
Mr. Woodworth. Three States have criminalized without
putting it under schedule.
Mr. Stupak. Right.
Mr. Reuter, I want to go back to where we were a little bit
more about the time line that has been taken. Let me ask you
this question.
If these States have already scheduled Ketamine and GHB
into various schedules, do you know how the States have been
able to move so quickly on this? Why have the States been able
to move quicker, and we have not been able to make any solid
recommendations here?
Mr. Reuter. Well, in referring to my written testimony in
this case and a little bit of the oral testimony as well, I
think we explained that our Office of Criminal Investigations
has been active in assisting the States, usually through their
legislative process, in adding Ketamine to the various
schedules of control available within their State offices.
There is a sense, I do not know precisely how many, but I
think there is a sense that many of the States have gone
through a legislative procedure to effect control.
Mr. Stupak. So if the feds did it legislatively, that is
fine too then? I mean, if the States can do it, we should be
able to take a lead and put it underneath one schedule so we
all know what schedule we are dealing with at least.
Mr. Reuter. Yes. I think in some of the testimony we even
cite some cases where legislative scheduling has been
accomplished with anabolic steroids and I also believe----
Mr. Stupak. Right.
Mr. Reuter. [continuing] with Methaqualone.
Mr. Stupak. My 5 minutes are up. Thanks.
Mr. Whitfield [presiding]. Thank you.
Mr. Bryant?
Mr. Bryant. Thank you, Mr. Chairman.
Ms. Maher, let me ask you a question. You may not have the
answer to this. Someone else may, but I want to ask this, and I
have several other questions I would like to follow with, so if
you could keep your answer as concise as possible that would be
great.
I ask you this because you are from the Department of
Justice. Again, you may know this, and you may not. Do
hospitals and law enforcement personnel have the resources to
adequately test for the presence of these date rape drugs in
the blood system?
Ms. Maher. I am not sure I am the person to ask on that. My
understanding is that they do not have, you know, all the tests
that might be helpful in testing for these, but I would defer
to others in answering that question.
Mr. Bryant. Okay. I have been in and out of the committee
in other committees, so I have missed some of I guess the
middle panel, which would probably have been the better one to
ask this to, but I understood there was a concern about the
inability in the testing to pick this up after the fact. Okay.
Maybe I can submit that to the other panel.
I also am very concerned about the length of time, the
delay involved at least on the administrative side of
reclassifying this drug. Mr. Reuter, going back to Mr. Upton's
question about the average time, the FDA's role in this is
typically eight to 10 months and this is going on I think
longer, and not just the FDA, but perhaps DEA to some extent
and Human Services to some extent.
This just does not seem to be a priority in terms of the
issues that we have heard from the first two panels, the
concerns that are out there. Tell me I am wrong.
Mr. Reuter. This is a very high priority. This is a very
serious matter to the Food and Drug Administration, and we have
been actively reviewing this. We have been actively gathering
more information to aid in our assessment on GHB. While we have
been doing that, we have been pursuing enforcement actions
under the Federal Food, Drug and Cosmetic Act.
I talked a little bit about our Office of Criminal
Investigation activities. It is one of the highest priorities
within our Office of Criminal Investigation, so indeed we do
place a very high priority on this.
Mr. Bryant. This decision by the FDA, is the paperwork not
in the Office of the Commissioner right now to make a decision?
My understanding is it has been there since early January of
this year, and I am wondering why are we still here in March
waiting for a decision?
Mr. Reuter. Well, I will go back and say we are very
actively reviewing this. It is an interagency review and
recommendation process. The ultimate decision on this is by the
Assistant Secretary for Health, as delegated under the CSA.
Mr. Bryant. Well, again my understanding is that the DEA
had made a request of the FDA in September 1998 for a
scientific determination on scheduling GHB, and the Division
had made a recommendation for Schedule III, which now resides
in the Commissioner's office. This is as of January 14, 1999.
Is it still in the Commissioner's office?
Mr. Reuter. It is still in the review process within the
Department of Health and Human Services.
A recommendation is not a recommendation until it really
leaves the Department of Health and Human Services. It is
probably not beneficial to split it out where it is in the
process because sometimes it could be in the Commissioner's
office, and my experience is it can go back for more thorough
review and rewriting. So, when it leaves the Department of
Health and Human Services, my experience is that is when the
recommendation is complete.
Mr. Bryant. Mr. Woodworth?
Mr. Woodworth. You asked also with DEA if it was a
priority, and I just wanted to tell you that it was an
extremely important priority.
Of the three drugs that we are discussing today, the other
two are made by legitimate manufacturers. Even though
Flunitrazepam is not available for use in the United States, it
is made by a pharmaceutical company.
GHB is not. It is of clandestine manufacture. That is what
is found here in the United States. It is made by criminals.
They make it mixing an industrial solvent with a drain cleaner.
Mr. Bryant. Is that against the law now?
Mr. Woodworth. Not federally.
Mr. Bryant. Okay. Just real quick, Mr. Reuter, if you would
give us a report, an answer? Could you tell me at least and
perhaps the committee precisely if the Commissioner has this
recommendation, exactly where it is in the FDA?
I understand that, you know, it can mean a lot of different
things, but really what we are looking for is just where it is
in the FDA in the process. You can do that after the hearing.
You can just submit a letter or something.
Mr. Reuter. Thanks. I prefer to do that.
Mr. Bryant. Thank you.
Mr. Whitfield. Thank you, Mr. Bryant.
Since I have not asked any questions, I think I will take
the prerogative as the chairman and ask some questions myself,
giving me 5 minutes. Thank you.
Ms. Maher, I notice you are with the Civil Division at the
Department of Justice. Maybe you are not the appropriate person
to ask these questions to, but when Representative Lee was
testifying she talked about the importance of an education
program to make young people more aware of the dangers out
there related to these types of drugs.
We were talking to her about funds available for
educational purposes as it relates to drug education, and she
mentioned that in the community relations department of the
Department of Justice that there was money available. Do you
know if that is the case?
Ms. Maher. I do not know specifically what she was
referring to.
Mr. Whitfield. Are you aware of any pool of money at the
Department of Justice that can be used for educational
purposes?
Ms. Maher. I am just not aware of that.
Mr. Whitfield. Okay. Is there any money over at FDA for
something like that or any of the other agencies represented
here today?
[No response.]
Mr. Whitfield. We will talk about that later.
Mr. Reuter. I would just say that I would be glad to check
and respond to that in writing.
Mr. Whitfield. You all are not really aware of any then.
Okay.
I also asked Representative Lee about what States already
have laws on the books relating to possession of GHB, and she
said two States, California and Pennsylvania. Someone mentioned
today that there are 18 States that already have this drug
classified as a Schedule I, II or III. Is that correct?
Mr. Woodworth. Twenty. Correct.
Mr. Whitfield. Twenty. Okay. When we say classified as
Schedule I, II or IV, does that mean that it is a felony?
Schedule I, II and IV, are those felonies or misdemeanors or a
combination thereof?
Mr. Woodworth. I would imagine it is a combination. Each
State is different, and I am unable to answer that other than
to speculate that possession would be covered by the States
that have it under control.
Mr. Whitfield. Okay. So there are more States than just two
that are dealing with this presently then, this issue?
Mr. Woodworth. Yes, sir.
Mr. Whitfield. Okay. The States of Texas, New Jersey and
Massachusetts were specifically mentioned. Who mentioned those
States?
Mr. Woodworth. I did.
Mr. Whitfield. What did you say about this?
Mr. Woodworth. They had criminalized the activity involving
GHB without placing it under a specific schedule.
Mr. Whitfield. Okay. So it is not under a schedule, but it
is criminalized.
Does the Department of Justice have an official position on
whether or not GHB should be placed on schedule?
Ms. Maher. When we were asked to testify, we had understood
that the committee was seeking our testimony on the experience
of the Office of Consumer Litigation in prosecuting cases under
the Federal Food, Drug and Cosmetic Act.
Since we learned earlier this week that the committee would
like a position from the Department as a whole, we have
commenced the process to seek input from other components other
than our office that would have views on that, and we can
provide that to the committee.
Mr. Whitfield. Okay. Okay. We would look forward to
receiving that then.
I think that is all the questions that I have. Are there
any other questions for this panel?
Mr. Stupak. Yes, Mr. Chairman.
What are the views then? What have you learned?
Ms. Maher. We have only begun this 2 days ago. We have
begun the process of seeking input from other components that
are interested, and we will provide that to the committee, but
I am not prepared to do that today.
Mr. Stupak. Would it help or hurt to?
Ms. Maher. Well, from a law enforcement perspective,
scheduling a drug will always provide additional tools to
prosecutors, but we understand that there are other
considerations in scheduling a drug other than simply the law
enforcement considerations so----
Mr. Stupak. Sure.
Ms. Maher. [continuing] from a law enforcement perspective
it would certainly help.
Mr. Stupak. Before you schedule a drug, you have to be
concerned about what schedule or what class you put it in, I,
II, III, IV, V, or liability reasons if there is a drug
manufacturer out there or someone else who wants to use the
drug for legitimate purposes because if it is not properly
classified you are subject to civil litigation. Is that
correct?
Ms. Maher. I do not----
Mr. Stupak. Maybe FDA can answer that.
Mr. Reuter. Yes.
Mr. Stupak. I mean, you just cannot willy nilly put one of
these drugs in Schedule I, II, III, IV, V. There are
consequences if it is illegally classified. I do not want to
say illegally. Improperly classified, correct? It has to stand
up in Court subject to judicial review, subject to lawsuits,
correct?
Mr. Reuter. Yes.
Mr. Woodworth. I would just----
Mr. Stupak. Yes. Go ahead.
Mr. Woodworth. [continuing] respond to that. For a
controlled substance, the Drug Enforcement Administration has
the final responsibility for defending the Federal decision on
a scheduling action.
Regardless of the schedule, it is possible to conduct an
activity to develop a drug. For example, if a drug is in
Schedule I, we do have a registration category for a
researcher, so research and development of the drug can
continue while it is placed under control.
Mr. Stupak. If the Congress passes a piece of legislation
that made GHB Schedule III, that would be Congress' statement
and, therefore, you would be not subject to these liability or
legal challenges? Is that correct?
Mr. Woodworth. I have maybe a three part response to that--
--
Mr. Stupak. Sure.
Mr. Woodworth. [continuing] if I might. Absolutely.
Congress can do that without regard to the criteria under 21
USC 812.
If Congress did so, I would suggest perhaps that a couple
of other things would apply. Schedule III would not include GBL
as an analog.
Mr. Stupak. Correct.
Mr. Woodworth. It would have to be in Schedule I or II.
Schedule III, of course, has a connotation of legitimate
medical use, and GHB does not have legitimate medical use.
Schedule III has a connotation of a lower level of abuse
than I and II, which DEA does not feel applies to GHB. We feel
that abuse is very high, if not severe, so there are some other
considerations that we would make.
Mr. Stupak. Sure. Go ahead.
Mr. Whitfield. I thought of a couple more questions.
Ms. Maher, do you have any idea when the Justice Department
might complete its study?
Ms. Maher. I guess I should not say soon, right? We can get
a view to the committee promptly, within I would imagine the
next several weeks.
Mr. Whitfield. The next several weeks. Okay. Good.
One other question for Mr. Woodworth. Does DEA have a
position on whether GBL meets the definition of an analog to
GHB?
Mr. Woodworth. We do, and it is in several pieces.
Mr. Whitfield. Okay.
Mr. Woodworth. First of all, GBL could not be considered as
an analog unless GHB is controlled----
Mr. Whitfield. Okay.
Mr. Woodworth. [continuing] in Schedule I or II only. If it
is scheduled in III, IV, V, it cannot be considered as an
analog.
Mr. Whitfield. Okay.
Mr. Woodworth. If GHB is scheduled in I or II, GBL would be
considered an analog if it met the definition of an analog,
which is to have a similar chemical structure to drugs in
Schedule I and II, has a stimulant, depressant or
hallucinogenic effect similar to drugs in Schedule I or II, or
has been represented to do so and is intended for human
consumption. That is a very important piece there.
What the analog provision does is it criminalizes the
illegal activity outside of the investigational new drug
process where development can continue. The only activity that
is criminalized is that illegal activity, but it must be
intended for human consumption.
This has to be proven in Court. There is not a list of
analogs. You would testify at Court that this met the
definition for an analog and was intended for human use.
I would point out one small possible difficulty with that
is that that would address GBL as a drug, not as a chemical, so
if GBL is----
Mr. Whitfield. Correct.
Mr. Woodworth. [continuing] given and represented to be for
human consumption, then it is covered. If GBL is just sold to
someone, there is not a further representation, then it would
not be considered as an analog.
Therefore, DEA would recommend that it be considered as a
listed chemical also covered under the Controlled Substances
Act as a List I chemical, and certain measures could be taken
to accommodate the industry, which has been very cooperative.
You may be aware that we have published a notice in the
Federal Register in October soliciting comments about GBL, and
the industry has been very cooperative and told us what their
concerns and needs are. That would be a possibility.
Mr. Whitfield. Okay.
Mr. Woodworth. I hope that answers your question.
Mr. Stupak. Mr. Chairman, may I?
As a listed chemical, that means tracking then, right, who
sold that chemical? We have some track as to the means and
where it went----
Mr. Woodworth. Absolutely.
Mr. Stupak. [continuing] and the amount, basically what our
legislation addresses?
Mr. Woodworth. Yes, sir.
Mr. Whitfield. You all are a popular panel.
Mr. Bryant?
Mr. Bryant. We just do not want you to go. Mr. Woodworth,
do I understand you to say that it would be DEA's position that
GHB ought to be scheduled as a Schedule I or II, as opposed to
III or IV, were Congress to act?
Mr. Woodworth. Yes, sir.
Mr. Bryant. And that GBL, the DEA's position would be that
preferably that it be scheduled itself on the CSA as a Schedule
I?
Mr. Woodworth. No, sir.
Mr. Bryant. No. As a chemical?
Mr. Woodworth. As a chemical. As a List I chemical, not as
a drug. That would cover the chemical aspects, and then the
analog provision would apply and address its use as a drug if
it is represented for human consumption.
Mr. Whitfield. Okay. We are going to have one more question
from Mr. Stupak, and then that is it.
Mr. Stupak. Thanks, Mr. Chairman.
I would just like to ask each on this panel has industry
been cooperative in your efforts and research and trying to
track and things like this, GBL especially?
Mr. Woodworth. With regard to GBL, the industry has been
extremely cooperative, yes.
Mr. Stupak. We have mentioned about four different drugs
here or byproducts. Has industry not been cooperative on any of
them, Ketamine or GHB or any of the others? Well, GHB is an
illegal drug, but Ketamine or the----
Mr. Woodworth. No. Not from DEA's point of view, no.
Mr. Stupak. Okay. Ms. Maher?
Ms. Maher. We would not really have occasion to seek
cooperation from industry.
Mr. Stupak. Mr. Reuter or Mr. Zukin?
Mr. Reuter. They have been cooperative, as far as I know.
Mr. Stupak. Okay.
Mr. Zukin. NIDA has not dealt directly with industry on
this matter.
Mr. Whitfield. Okay. I want to thank----
Mr. Stupak. Just one follow up.
Mr. Woodworth, if you listed GBL, would it put any burden
on industry? Can they live with it?
Mr. Woodworth. We would design it with their comments in
mind----
Mr. Stupak. Sure.
Mr. Woodworth. [continuing] where there would be specific
exemptions to prevent sale to consumers, for example.
Most of the activity is very large quantities of GBL. There
are tens of thousands of tons produced in the United States.
What people need for GHB production is a very small quantity.
That is what we would focus on. We would craft our regulation
to do exactly that.
Mr. Stupak. Sure. You just would not allow it to show up at
Post Office Box 143 up in Menominee, Michigan.
Mr. Woodworth. Right. Yes, sir.
Mr. Whitfield. I want to thank this panel for your
patience. We really appreciate your testimony. We look forward
to hearing from you and working with you on this important
issue. Thank you.
Now at this time we will call Ms. Patti Engel, who has also
been very patient. We apologize that she has had to wait so
long.
Mr. Upton. Ms. Engel, welcome to the subcommittee.
Ms. Engel. Thank you.
Mr. Upton. As you have heard undoubtedly the other
panelists, do you have any objection to swearing under oath,
and do you have a counsel that you need to have?
Ms. Engel. No.
Mr. Upton. Terrific.
[Witness sworn.]
Mr. Upton. Thank you very much. I recognize you for 5
minutes. Your whole statement will be made as part of the
record.
Ms. Engel. Thank you.
Mr. Upton. We appreciate you having the indulgence to stay
with us most of the day.
TESTIMONY OF PATTI ENGEL, ORPHAN MEDICAL, INC.
Ms. Engel. Mr. Chairman and members of the committee, my
name is Patti Engel, and I work for Orphan Medical, a very
small company in Minnesota that specializes in developing
medications for people who suffer from rare diseases, life
threatening rare diseases that most people have never even
heard of.
Mr. Chairman, before I begin my comments, I want to respond
to two comments that were previously made. First, I want to
state unequivocally that Orphan Medical does not believe that
scheduling GHB as a Schedule III will magically somehow produce
an FDA approval. We know that the data in our NDA will be the
basis for approval; nothing less.
Second, I want to assure you that Orphan Medical does
indeed understand how this drug affects the human brain in
patients with narcolepsy.
I would like to say at the outset that Orphan Medical
agrees with this subcommittee and others that the use of GHB or
any other chemical to commit a crime, especially a rape, is
unconscionable, and they must be severely punished. We know,
too, that home-brewed GHB is dangerous.
We agree that the illicit use of GHB must be stopped, but
we also believe that dealing with complex issues that can at
one time save lives and other times hurt them is complex and
should be looked at from various perspectives. We appreciate
the opportunity to share this perspective with you.
Orphan Medical first learned about GHB in 1994. At that
time, the FDA did something that it does not often do. The FDA
Office of Orphan Products asked us to develop this drug to
treat the disabling symptoms of narcolepsy called cataplexy.
The FDA believed GHB was a promising medication, but had been
unable for 20 years to generate any commercial interest in this
agent. Because orphan drugs are our business, we accepted this
challenge.
While the daytime sleepiness component of narcolepsy is
treated with a number of medications, including a newly
approved medication called Modafanil, there is virtually
nothing that works for cataplexy, the condition that GHB
treats. For many years, doctors have treated cataplexy with
anti-depressants. Unfortunately, these medications do not
really treat the disease itself and thus are not truly
effective.
About 10 years ago, FDA learned that GHB could treat
cataplexy in a very different way. The drug appears to induce a
restful sleep that people with narcolepsy do not typically
experience. It promotes REM or rapid eye movement sleep,
thereby reducing cataplexy attacks.
About 5 years ago, after Orphan Medical was contacted by
FDA about developing this medication, I myself had the chance
to visit sleep centers and talk to patients who had used this
experimental agent in clinical trials. I spoke firsthand to
patients who told me that GHB had changed their lives. The use
of GHB had reduced cataplexy attacks in some patients from 50 a
day to two a month. It enabled patients to work, to go to
school, to live normal lives.
Frankly, these testimonials sounded too good to be true,
and we were skeptical and knew that we had to put this drug to
scientifically rigorous tests to validate or to disprove the
claims of the patients and the researchers with whom we talked.
In 1998, under FDA's guidance, we initiated rigorous, well-
controlled clinical trials at sleep centers in 14 States to
study the use of GHB. The FDA considered our findings of GHB
safety and efficacy for controlling the symptoms of narcolepsy
to be significant and asked us to conduct a treatment IND to
increase patient access to this promising new medication.
The data collected under the treatment IND will be added to
the years of evidence we have already collected and will be
used in our NDA. We expect to submit our NDA later this year or
early next.
During the time that we have been developing GHB as a
treatment for cataplexy, concern about its illicit use has
grown, but it is very important to note that no medical grade
GHB has ever been diverted for illicit use despite its use in
clinical trials in 14 States.
We share the concern for public safety that has been
eloquently described today, and over the past 3 years we have
worked with FDA, DEA and Members of Congress to find an
appropriate way to control this illegal use.
Our goal and message have been consistent. Severely punish
those who illegally manufacture, distribute or possess GHB and
its analogs. Severely punish sexual predators who would use
this and any chemical to commit assaults, but do so without
denying narcolepsy patients access to the only medication that
will treat their cataplexy.
We suggested to various Members of Congress that one
solution to this extremely serious problem is to amend the CSA
to list GHB as a Schedule IV controlled substance, but to
punish anyone who manufactures, distributes or possesses GHB or
its analogs with Schedule I penalties.
It is important to recognize that the chemical precursor,
GBL, needs to be considered. Today, GBL, as you have heard, is
used legally by manufacturers of paints, beer and electronics,
but there is absolutely no reason for any individual to possess
GBL.
You have heard this morning about the problems associated
with GBL, which is called scoop. GBL will not be stopped by
making GHB a Schedule I. Some have suggested that the solution
to this problem is to take action at a national level, and we
agree wholeheartedly.
We believe that the proposal to solve this terrible problem
by listing GHB as a Schedule I or controlled substance would in
fact have dire consequences for patients with narcolepsy,
whether the scheduling is done during research or after the
drug is approved by FDA, and let me explain.
The fact that Schedule I drugs can be used in research,
while technically accurate, does not respond to the real world
difficulties of working with such a product. Research studies
can only be done if a company can manufacture the drug or find
a manufacturer willing to make it and if doctors are willing to
participate in the clinical trials.
If GHB were put as a Schedule I, the company which
currently manufactures the pharmaceutical grade GHB for the
clinical trials will cease production. We have also been told
that sleep centers now participating in the clinical trials
would not participate if GHB were a Schedule I substance.
While theoretically we could find another manufacturer, we
have been unable to locate someone willing to do so to date
because of the very limited commercial potential of this agent.
Even if GHB were listed as a Schedule II agent, a 20,000-
square-foot vault made of 8-inch thick concrete walls would be
required. At an estimated $20 million, that would more than
double the cost of developing this agent, which is an agent
used for a very rare disease. We would be forced to tell FDA to
find another company willing to develop this drug, and the
patients who need this for narcolepsy would be forced to wait
many more years.
We hope that you will agree that the medical grade GHB
should be listed as a Schedule III or IV and that criminals who
use this and other chemicals to perpetrate crime should be
penalized.
Mr. Stupak's bill and, as we have heard this morning, Ms.
Jackson-Lee's proposed amendments to her bills are approaches
that strike the right balance between punishing wrongdoers and
preserving patient access to crucial medicines.
I also want to mention that statements are attached to my
testimony from the American Sleep Disorder Association, from
the National Association for Rare Diseases and the National
Sleep Foundation, and I respectfully request that these
statements be included in the hearing record along with my full
written statement.
Thank you for the opportunity to testify.
[The prepared statement of Patti Engel follows:]
Prepared Statement of Patti Engel, Vice President, Orphan Medical, Inc.
Mr. Chairman and Members of the Committee, my name is Patti Engel.
I work for Orphan Medical, a very small company in Minnesota that
specializes in developing medicines for people who suffer from rare
diseases--life-threatening rare diseases that most people have never
heard of.
One such disease is Congenital Sucrase-Isomaltase Deficiency. This
is a genetic disorder that leaves children unable to digest common
table sugar and some starches, leading to malnutrition and
developmental delays. Another orphan disease for which we have
developed a drug is Homocystinuria, which affects children by making
them unable to metabolize homocystine. This condition leads to mental
retardation, blindness, and death.
Both of these conditions affect fewer than 1,000 children in the
US. The medicines we've developed help people with these orphan
conditions and others live more normal lives.
Currently, Orphan Medical is working to complete the studies needed
for approval of a New Drug Application (NDA) for the drug
gammahydroxybutyrate (GHB) to treat the most severe form of narcolepsy.
I'd like to say at the outset that Orphan Medical agrees with this
Subcommittee and others that use of GHB or any other chemical or drug
to commit a crime--especially a rape--is unconscionable and must be
severely punished. We know too that ``home-brewed'' GHB is dangerous.
We agree that illicit use of GHB must be stopped. But we also believe
that dealing with a substance that can at once save lives and hurt them
is complex and should be looked at from various perspectives. We
appreciate the opportunity to share our perspective with you.
Orphan Medical first learned about GHB in 1994. The FDA Office of
Orphan Products asked us to develop this drug to treat the disabling
effects of narcolepsy. The FDA believed GHB was a promising therapy,
but had been unable for 20 years to generate any commercial interest in
the drug. Because orphan drugs are our business, we accepted this
challenge.
Narcolepsy is a rare, disabling sleep disorder that affects about
180,000 Americans. Many think of narcolepsy as a disease that causes
people to fall asleep at inappropriate times, but actually it is much
more serious than that. About 65% of narcolepsy patients experience a
symptom of the disease called cataplexy--sudden and total loss of
muscle control. A total cataplectic attack results in immediate,
complete body collapse. This can happen anywhere or at any time, no
matter what a person is doing--walking, driving, swimming, or holding a
baby. During these attacks the patient appears unconscious; in reality,
however, the person is quite alert and awake, but unable to talk, move,
or even remove himself or herself from a potentially dangerous
situation. Cataplexy is often triggered by stress, fatigue, or
emotional reactions such as laughter, fear, surprise, or sadness.
Because of the unpredictability and frequency of attacks, people
with cataplexy are unable to live normal lives. They often can't work
outside the home or drive a car. They can't go to a movie, mow the
lawn, or hold a baby.
While the daytime sleepiness component of narcolepsy is treated
with a number of medications, including a newly approved medication
called Modafanil, there is virtually nothing that works for cataplexy.
For many years, doctors have treated cataplexy with antidepressants in
an effort to ``flatten'' the emotional outbursts which can lead to an
attack. Unfortunately, these medicines do not really treat the disease
itself and thus are not truly effective. Furthermore, antidepressants
often have undesirable side effects, not to mention that patients are
unable to experience fully the emotions that you and I associate with
normal life.
About 10 years ago, the FDA learned that GHB could treat cataplexy
in a different way. This drug appears to induce a restful sleep that
people with narcolepsy don't ordinarily experience. It promotes REM, or
rapid eye movement sleep, thereby reducing cataplexy attacks.
Early on, FDA approached some drug companies about developing GHB
as an orphan drug, and several actually started development. However,
as they ran into challenges, each of these companies abandoned the
project, in part because the very limited commercial market potential
made this an unfavorable investment of research funds.
About 5 years ago, after Orphan Medical was contacted by FDA about
developing GHB, I had the chance to visit some sleep centers where the
drug was being used as an experimental treatment for narcolepsy
patients. I spoke first-hand to patients, who told me that GHB had
changed their lives. Use of GHB reduced cataplexy attacks in some
patients from 50 a day to 2 a month. It enabled patients to work, go to
school, live a normal life.
Frankly, these testimonials sounded too good to be true. We were
skeptical and knew we had to put this drug to a scientifically rigorous
test to validate or disprove the claims of the patients and the
researchers with whom we had talked.
In 1998, with FDA's guidance, we initiated rigorous, well
controlled clinical trials at sleep centers in 14 states to study the
use of GHB as a treatment for narcolepsy. In August 1998 we presented
the clinical findings from this study to FDA.
The FDA considered our findings of GHB safety and efficacy for
controlling the symptoms of narcolepsy to be so significant that they
asked us to conduct a ``treatment IND,'' to increase patient access to
this promising new drug. It is important to note that a treatment IND
is a mechanism to make available to patients, outside of clinical
trials, promising therapies for serious and life-threatening diseases
for which there are no satisfactory alternative treatments. In the
past, drugs for cancer, AIDS, severe Parkinson's' Disease, multiple
sclerosis, respiratory distress syndrome in infants, and diabetes have
been made available under treatment INDs. Now, narcolepsy patients also
will benefit from this.
The data collected under the treatment IND will be added to the
years of evidence we've already collected, and will be used in our NDA.
We expect to submit our NDA later this year or early next year.
During the time that we've been developing GHB for the treatment of
narcolepsy, concern about its illicit use has grown. As you already
have heard, information about how to make and use GHB is readily
available on the Internet. Its chemical precursor, gammabutyrolactone
(GBL), is readily available and can be obtained easily. Anyone with a
computer, credit card, and the inclination to surf the Net can find the
recipe, buy the ingredients, and make a batch of ``home-brewed'' GHB.
Because the material is home-brewed, the levels of toxicity vary
dramatically, a capful of one batch may be as toxic as a cup of
another.
It is very important to note that no medical grade GHB has ever
been diverted for illicit use, despite its use in clinical trials in 14
states.
The ``reputation'' of GHB and its easy manufacture have caused
tremendous problems for law enforcement. We share the concern for
public safety that has been so eloquently described this morning. Over
the past three years, we have worked with FDA, DEA, and members of
Congress to find an appropriate way to control the illegal use of GHB.
Our goal and message have been consistent: Severely punish those
who illegally manufacture, distribute, or possess GHB or its analogs.
Severely punish sexual predators who would use this chemical to commit
an assault. But do so without denying narcolepsy patients access to the
only medication which will treat their cataplexy.
We have suggested to various members of Congress that one solution
to this extremely serious problem is to amend the Controlled Substances
Act to list GHB as a Schedule IV controlled substance, but to punish
anyone who manufactures, distributes, or possesses GHB or its analogs
with Schedule I penalties. That is, on conviction of these illegal
acts, a person would be subject to imprisonment of up to 15 years and a
fine of up to $250,000.
Mr. Chairman, we maintain that such Schedule I level penalties are
at the heart of the issue. As the recent tragedy in Michigan has shown,
simply having a substance on Schedule I is not a deterrent. But knowing
that you are going to get 15 years in prison and a quarter-million-
dollar fine is.
A similar approach was taken in the 1996 Date Rape Act, supported
by both Republicans and Democrats. This Act effectively adds 10 years
to the rape conviction of anyone who used any substance to facilitate a
sexual assault.
Mr. Chairman and members of the committee, it is also important to
recognize that the chemical precursor of GHB, GBL, and chemical analogs
of GHB also need to be considered. Today, GBL is used legally and
appropriately by manufacturers of paints, beer, and electronics. One
key to stemming the illicit manufacture of GHB is to criminalize the
illegal use and possession of GBL. There is absolutely no reason for
any individual to possess GBL. If an individual, as opposed to a
legitimate manufacturer, has GBL, it is for one reason, and that is to
make GHB, or to use it as if it were GHB.
GBL is the necessary ingredient in making GHB. As I mentioned
earlier, GBL is easy to find and purchase. Nearly 100% pure GBL can be
purchased off the Internet for as little as $35. Or, if a person is
looking to run a major GBL trafficking operation, the chemical can be
obtained in bulk with little if any screening of the purchaser. As a
test, last summer we contacted four reputable chemical suppliers. We
used a false company name, a false phone number, and a credit card. Two
of these suppliers quickly offered to set up an account for us to
obtain GBL in huge quantities.
Florida authorities tell us that last year illicit manufacturers of
GHB learned they did not have to bother going to the trouble of brewing
GHB. They discovered that GBL is naturally converted in the body to
GHB. Now, they are just selling caps full of diluted GBL. They call it
``Scoop.'' A small bottle of GBL can be diluted to make 50 doses of
``Scoop.'' At about $20 per dose, that's a lot of money for the dealer.
A sexual predator could use the GBL in a small bottle to help him
commit as many as 15 sexual assaults.
In Florida, GHB abuse is dropping as GBL abuse is increasing.
Florida law enforcement officials tell us that the demographics of
abusers have changed, and that while GHB abuse was occurring among 20-
30 year olds, GBL abuse is occurring among 15-20 year olds. This is an
outrage. Making GHB a Schedule I agent will do nothing to prevent this.
Florida has responded to this problem by modifying its statutes and
including GBL as a controlled substance.
Some have suggested that the solution to this problem is to take
action at the national level. We agree wholeheartedly. However, we
believe the proposal to solve this terrible problem by listing GHB as a
Schedule I or II controlled substance would have dire consequences for
patients with rare diseases, whether that scheduling is done during the
research or after the drug is approved by FDA. Let me explain what I
mean.
The fact that Schedule I drugs can be used in research, while
technically accurate, does not respond to the real-world difficulties
of working with such a product. Research studies can only be done if a
company can manufacture the drug or find a manufacturer willing to make
it, and doctors are willing to participate in trials which use a
Schedule I drug. If GHB were listed as a Schedule I substance, the
company which currently manufactures pharmaceutical grade GHB for our
clinical trials would cease production. We also have been told that
sleep centers now participating in our clinical studies in at least
some cases would not participate if GHB were a Schedule I substance.
While theoretically we could find another manufacturer, we have
been unable to date to locate one willing to manufacture a product of
such low volume and potential profitability, even if the drug is not a
controlled substance. This difficulty would be exacerbated if we were
seeking a manufacturer to make a Schedule I substance. The reason for
this is the enormous investment a manufacturer would have to make, for
the small financial return of an orphan drug.
Even if GHB were listed as a Schedule II agent, a 20,000 square
foot vault (the size of a small airplane hangar) with 8-inch concrete
walls would be required to store the pharmaceutical-grade GHB. The cost
of construction, estimated at $20 million, would more than double the
costs of developing this drug. The economic disincentive alone would
result in a discontinuation of the clinical trials, the NDA process,
and the hopes of narcoleptic patients with cataplexy. We would be
forced to tell FDA to find another company willing to develop this
medication for this rare disease. The history of GHB tells us that
narcolepsy patients would have to wait many more years for GHB to be
available to them.
We hope you will agree that medical grade GHB should be listed as a
Schedule III or IV drug and that criminals who use this or other
chemicals to perpetrate crimes should be severely penalized.
I want to thank you for the opportunity to testify and would be
happy to answer any questions.
______
American Sleep Disorders Association
the use of ghb in treating narcolepsy
position statement & recommendations of the asda
Rationale
The following position statement was commissioned by the American
Sleep Disorders Association (ASDA) Board of Directors and provides a
review of the evidence on gamma-hydroxybutyrate (GHB) as well as
recommendations for its classification schedule. The report focuses on
proven scientific and therapeutic uses of GHB; potential for abuse; and
how GHB might best be classified if it becomes a controlled substance.
The best, published evidence from peer-reviewed, scientific journals
about GHB was considered and primary observations other than reviews,
editorials, letters, or reports in newspapers and magazines were
concentrated on.
Proven Therapeutic Use Of GHB In Narcolepsy
Several independent investigators have reported beneficial effects
in narcolepsy with GHB but only 2 double-blind studies have been
published (Scrima et al, 1989 and 1990; Lammers et al., 1993). The
first was performed by Scrima (1989 and 1990) in 20 patients using 50
mg/kg/night. A significant decrease in cataplexy was observed but no
significant effects on daytime sleep attacks were reported when
compared to placebo. The second study was performed by Lammers (1993).
Twenty-four patients received GHB, 60 mg/kg/night. Hypnagogic
hallucinations and daytime sleep attacks decreased significantly.
Cataplexy was also reduced by 50 percent, but the effect was not
significantly different from placebo due to large inter-individual
variation. In both studies, sleepiness as measured using MSLT sleep
latencies was only slightly affected (maximum difference in mean sleep
latency: 1 minute).
Based on these two reports, there is little doubt that the drug is
helpful to narcoleptic patients. Several other independent
investigators have confirmed the findings in open labeled studies
(Broughton and Mamelak, 1979; Mamelak et at., 1986). The most
consistent and least controversial effects are improved cataplexy and
improved nocturnal sleep disruption with GHB treatment (Scrima et al.,
1990; Broughton and Mamelak, 1980: Bedard et al., 1990). Further
investigations would be needed to confirm a possible beneficial effect
for daytime sleepiness.
Importantly, GHB anti-cataplectic effects are clearly mediated by a
different mode of action when compared to those produced by
antidepressant compounds. As such, patients who do not tolerate
classical antidepressant treatment because of side effects, tolerance
or contraindications would not have any other choice if GHB were not
available to them.
Therapeutic Use Of GHB In Other Medical Disorders
Besides its demonstrated efficacy in narcolepsy, GHB has proved
useful when evaluated in controlled trials for anesthesia (Kleinschmidt
et al., 1997; Kleinschmidt et al., 1998) and for treatment of
withdrawal syndromes (Gallimberti ct al., 1989; Gallimberti et al.,
1992; Gallimberti et al., 1993).
Use Of GHB In Basic Neuroscience Research
GHB is a unique tool in neuroscience research. Maitre (1997) just
reviewed the neurobiology of GHB. The compound is a natural metabolite
of GABA; it is synthesized and accumulated in neurons in the brain.
Investigators have shown that GHB behaves as a genuine CNS
neurotransmitter distinct from GABA. GHB receptors have been identified
and a pharmacological antagonist of the compound (NCS-382) has been
synthesized. The most established pharmacological effect of the
compound is to dramatically decrease the firing rate of
mesocorticolimbic dopaminergic neurons in the brain while activating
dopamine synthesis. This effect produces an acute increase in dopamine
stores. Higher doses are also believed to activate GABA-B receptors.
One of the most interesting properties of the compound is its
ability to increase both REM and Slow Wave Sleep (SWS). Almost all
other hypnotic compounds available to us suppress REM and SWS, thus GHB
produces a more ``natural'' sleep architecture. This difference in
profile has been established in several animal species including
humans. It is also clear that not only the hypnotic profile of GHB but
also its mode of action is distinct from all other commonly prescribed
hypnotic compounds. No other known compound has the paradoxical effect
on dopaminergic transmission described above. As such, it is not only
an interesting compound but research in the area may lead to the
discovery of novel hypnotics that may have clinical application far
beyond narcolepsy.
Prevalence And Severity Of GHB Abuse
GHB, also known as sodium oxybate, is a naturally-occurring fatty
acid derivative that is neuroactive and has abuse potential. GHB has
powerful depressant effects on the central nervous system and has been
used as an anaesthetic, however in lower doses it can produce a state
of euphoria which has led to popular recreational use (Li et al, 1998).
Also, GHB has been used by bodybuilders because of its anabolic
effects. Physical dependence can occur. In addition, prolonged abuse
may result in seizures and withdrawal symptoms. The withdrawal syndrome
includes insomnia, anxiety and tremor that usually resolves in 3-12
days.
GHB has been referred to as a ``date rape'' drug when combined with
flunitrazepam, because of the tendency to induce initial euphoria and
subsequent CNS depression. Excessive intake of GHB has led to serious
sequelae including respiratory arrest and death.
Typically, profound unconsciousness occurs in severe GHB toxicity,
and despite full (and often rapid) recovery, most patients require
medical intervention, including intubation and mechanical ventilation.
Interestingly, GHB has hypoxia-sparing effects that may aid the total
recovery seen in the majority of cases of severe toxicity. The adverse
effects are more serious when GHB is used with other illicit drugs and
alcohol (Ryan et al., 1997). Of the 10 deaths reported with GHB all
have been associated with the use of mixed drugs (Li J, personal
communication). However, in lower doses, the drug has been used to aid
withdrawal from opiate and alcohol addiction. GHB has led to abstinence
of alcohol in 78% of 179 alcohol dependent subjects (Addorato et al.,
1996).
Although available since 1990, the current prevalence of GHB use is
not known, however it is believed that it is relatively low compared
with cocaine and marijuana. In 1995-1996, poison control centers in New
York and Texas reported 69 acute poisonings and one death attributed to
GHB (JAMA, 1997).
Since the recent widespread publicity about GHB there have been
numerous sources of information available on how to make GHB,
particularly on the internet. GHB can be easily synthesized from
Lactone (ganuna hydroxybutyral lactone), also a potent euphoric drug
that is inexpensive and occasionally sold as GHB. Lactone is widely
used and available in industry with little prospects of regulation of
its availability. Two states have made GHB a schedule I drug, and 20
states have made it a misdemeanor or felony to distribute GHB (Li J,
personal communication). Most states have legislation pending.
Recommendations Of The ASDA
GHB has demonstrated therapeutic usefulness in narcolepsy, cardiac
anesthesia, and withdrawal syndromes. GHB abuse is a problem, but there
is no documented evidence that supplies of GHB from the medical and
scientific community have been diverted for illegal uses.
Classification of GHB as a Schedule I drug is likely to impede further
research into clinical and scientific applications of GHB. The ASDA
opposes a Schedule I classification of GHB.
References:
Addorato G, Castalli E, Stefani GF, Casella G. An open multicentric
study evaluating 4-hydroxybutyric acid sodium salt in the medium term
treatment of 179 alcohol dependent subjects. Alcohol 1996;31(4):341.
Bedard MA, Montplaisir J, Godbout R., Lapierre O. Nocturnal Gamma
Hydroxybutyrate. Clin. Neuropharmacology 1989;12(1):29-36.
Benet LZ. Principles of prescription order writing and patient
compliance instructions. In: Hardman JG, Limbird LE (Eds). Goodman and
Gilman's The Pharmacological Basis of Therapeutics (9th Edition),
McGraw Hill, New York, 1996:1703.
Broughton R, Mamelak M. The treatment of narcolepsy-cataplexy with
nocturnal Gamma-Hydroxybutyrate. J Cann Neurol Sci 1979;6:1-6.
Broughton R, Mamelak M. Effects of nocturnal Gamma-Hydroxybutyrate
on Sleep/waking patterns in nucolepsy/cataplexy. J Cann Neurol Sci
1980;7:23-31.
From the Centers for Disease Control and prevention. Gamma
Hydroxybutyrate use--New York and Texas. JAMA 1997;21:277(19):1511.
Gallimberti et al. Gamma-hydroxybutyric acid for treatment of
alcohol withdrawal syndrome. Lancet 1989;2(8666):787-9.
Gallimberti et al. gamma-Hydroxybutyric acid in the treatment of
alcohol dependence: a double-blind study. Alcohol Clin Exp Res
1992;16(4):673-6.
Gallimberti et al. Gamma-hydroxybutyric acid for treatment of
opiate withdrawal syndrome. Neuropsychopharmacology 1993;9(l):77-81.
Kleinschmidt S, et al. Total intravenous anaesthesia using
propofol, gamma-hydroxybutyrate or midazolam in combination with
sufentanil for patients undergoing coronary artery bypass surgery. Eur
J Anaesthesiol 1997;14(6):590-9.
Kleinschmidt S, et al. Total intravenous anaesthesia with gamma-
hydroxybutyrate (GHB) and sufentanil in patients undergoing coronary
artery bypass graft surgery: a comparison in patients with unimpaired
and impaired left ventricular function. Eur J Anaesthesiol
1998;15(5):559-64.
Li J, Stokes SA, Woeckener A. A tale of novel intoxication: a
review of the effects of gammahydroxybuyric acid with recommendations
for management. Ann Emerg Med 1998;31(6)729
Maitre M. The Gamma-Hydroxybutyrate signalling system in brain:
Organization and functional implications. Prog Neurobiol 1997;51:337-
361.
Mamelak M, Scharf M, Woods M. treatment of narcolepsy with
gammahydroxybutymte: a review of clinical and sleep lab findings. Sleep
1986;9:285-289.
Ryan JM, Stell I. Gamma hydroxybutyrate--a coma inducing
recreational drug. J Accid Emerg Med 1997;14(6):411.
Scrima L, Hartman PG, Johnson FG, Thomas EE, Hiller FC. Efficacy of
Gamma hydroxybutyrate versus placebo in treating narcolopsy-cataplexy:
double blind subjective measures. Biol Psychitry 1989;26:331-343.
Scrima L, Hartman PG, Johnson FG, Thomas EE, Hiller FC. The affects
of Gamma-hydroxybutyate on the sleep of narcoleptic patients: a Double
blind study. Sleep 1990;13:479-490.
Sharf MB, Brown D, Woods M, Brown L, Hirschokitz J. The effects and
effectiveness of gammahydroxybutyrate in patients with narcolepsy. J.
Clin Psychiatry 1985;46:222-225.
Mr. Upton. Without objection. We again appreciate you
waiting this long during the day to come before us.
I do not really have a question. I have a comment, and that
is I sense that we are all on the same page. I do not know the
best way to do it, but from Fred Upton speaking I want to see
this stuff stopped from getting into our kids' systems. I want
to do it in a way that it is not going to trigger or see it
trigger some precursor or some analog which is going to come
about, whether it be GBL or some further hybrid later on.
As I begin to scratch the surface on this, I do not know
whether it is better to have a Schedule I, II, III or IV with
appropriate penalties, but I think based on what I heard you
just say as part of your testimony is that from industry's
perspective, at least yours, you would like to see it at least
Schedule IV, if not Schedule III--I understand your concerns
with Schedule II--with some type of penalty along the lines
that we have seen in either Ms. Sheila Jackson-Lee's bill or my
colleague Bart Stupak's bill with the penalties so that you
cannot move to that second or third or fourth step where we
heard so much testimony particularly from the States.
Actually, one of the questions I wanted to ask Panel 2, and
I think it stemmed from Mr. Dingell's question. We do not
really have a kit to even decipher where we can find it, and it
is because it is odorless. It is tasteless. It is easily passed
off as water.
If we get the appropriate stop gates to prevent it, it
seems to me that at least your industry, and probably other
industry folks, would be happy. Is that correct?
Ms. Engel. That is correct, Mr. Chairman.
I would like to add that Orphan Medical has in fact a
validated assay for GHB and is very willing and has shared its
willingness with law enforcement and whatnot as to working
together to be able to help come to solutions to these
challenging problems.
While we are a small company and, unlike what you heard
earlier, we are, frankly, not profitable----
Mr. Upton. I know Minnetonka. I do not think there is
anything big in Minnetonka.
Ms. Engel. We are not able to do that ourselves, but we
would welcome the opportunity to work with law enforcement to
assist them with the already in hand knowledge that we have
about this compound and about its assay methodology.
Mr. Upton. Thank you.
Mr. Stupak?
Mr. Stupak. Thank you.
Ms. Engel, I take it then you could support our bill, which
would place this GHB as a Schedule III with Schedule I
penalties?
Ms. Engel. Yes, we would support that bill, especially
given the penalties as Level I for the possession, distribution
and manufacture of not only GHB, but all of its precursor
chemicals and analogs.
Mr. Stupak. So the tracking of----
Ms. Engel. Exactly.
Mr. Stupak. There is no problem then with the chemical
with----
Ms. Engel. No.
Mr. Stupak. [continuing] your use?
Ms. Engel. No. As I mentioned earlier, the GBL is widely
used in much commercial manufacture.
Mr. Stupak. Right.
Ms. Engel. Paints, beers, plastics components. These
manufacturers are quite accustomed to dealing with regulated
chemicals.
Mr. Stupak. Tell me a little bit more about your testing
that you think may be of some help to law enforcement to do a
test kit, an on the road test kit.
Ms. Engel. Currently in our clinical trials, we assay the
patient's blood for the presence of GHB. I am not a scientist
by training so I do not want to mis-speak, but I believe the
test is a GC mass methodology.
Mr. Stupak. So you would have to draw blood?
Ms. Engel. Yes.
Mr. Stupak. So then we are back to the idea of search
warrants.
Ms. Engel. What we learned from Dr. Ward Donovan just a few
days ago, who runs the Poison Control Center at Penn State-
Geisinger in Pennsylvania, is that it is not impossible by any
means to do GHB levels.
It is very common, however, that the typical emergency room
screening that is used when a patient is admitted----
Mr. Stupak. Sure.
Ms. Engel. [continuing] does not include that, so unless a
physician is aware of GHB and GBL and knows to ask for a GHB
screening, it does not happen, but those tests are available.
Mr. Stupak. But that would be more emergency room setting,
right?
Ms. Engel. That is exactly right. As----
Mr. Stupak. Does it become--I am sorry.
Ms. Engel. I am sorry. I was going to mention as I
mentioned, we would be willing to work with whatever agencies
would be willing to assist us in the development of forensic
testing, would that be possible.
Mr. Stupak. Having been in law enforcement, you try to do
it in the field. We usually have a kit, and we put a drop of
this or a drop of that and see what kind of color it turns,
which would indicate, not conclusively conclude, that a drug
may be present in this substance.
With the vials and little containers that Ms. Porrata had
earlier, that is what law enforcement is running into, and they
need some kind of field test to see if GHB or whatever is
present in those substances.
Ms. Engel. Yes.
Mr. Stupak. I have no further questions, Mr. Chairman.
Mr. Upton. Mr. Whitfield?
Mr. Whitfield. I just have one question, Mr. Chairman.
If you placed GBL into a Schedule III, which Mr. Stupak's
bill does, I believe----
Mr. Upton. GHB or GBL?
Mr. Whitfield. I think it is GHB. GHB into Schedule III,
which you recommend, it is my understanding that there are like
17 or 18 different analogs out there and that in doing that you
are not able to take care of the other analogs or cover those.
How would you respond to that?
Ms. Engel. Well, what I can tell you is that in the State
of Florida they have utilized legislative language that deals
with gamma hydroxy butyric acid. It is esters, it is ethers, it
is salts and any isomers of esters, ethers or isomers.
They believe there that no matter how you do this language,
you are going to have some very bright bathtub chemist within a
few years find a loophole, so in Florida what they have
attempted to do is make the legislative language so very broad
that any creative chemist would not find a loophole around it.
We would support that same approach.
By utilizing the scheduling process and to put GHB in a
gross schedule of a I suggesting no appropriate medical use or
a Schedule II or the easy fix, if you will, of being able to
deal with its analogs, we appreciate that that may be easy for
law enforcement, but, unfortunately, this is not an easy
problem.
There are patients out there with a condition called
cataplexy who have no other options, and we believe that a
complex situation like this will and does require some complex
thought and thus have supported very strongly Mr. Stupak's bill
and these more encompassing languages.
Mr. Whitfield. I yield to Mr. Stupak.
Mr. Stupak. My legislation does that with the ethers, the
salts and all that, but how is it working in Florida? Is it
working?
Ms. Engel. The language there was only recently passed.
From what we hear from law enforcement there is that they are
now able to go after the GBL issue, so, you know, that is what
I know today.
Mr. Stupak. Has any derivative drug developed from it?
Ms. Engel. Not that we know of.
Mr. Stupak. Thanks.
Mr. Whitfield. I yield back the balance of my time. Thank
you.
Ms. Engel. Thank you.
Mr. Upton. Again, I appreciate your testimony and all those
folks that came and were with us for the day.
I think we have outlined a very serious trouble that really
does need some action. I certainly am prepared to work with my
colleagues to address this situation so that it no longer could
remain as a nightmare for parents across the country.
Thank you very much. This hearing is adjourned.
[Whereupon, at 2:25 p.m. the subcommittee was adjourned.]
[Additional material submitted for the record follows:]
Prepared Statement of Abbey S. Meyers, President, National Organization
for Rare Disorder
Mr. Chairman and Members of the Subcommittee: as many on this
Committee already know, the National Organization for Rare Disorders
(NORD) represents patients and families of patients with rare, or
orphan, diseases and disorders. For most of these people, there is no
therapy or treatment; for many, treatments are offered that are costly
and ineffective. Orphan conditions are often life-threatening,
frequently disabling, and always physically and psychologically
debilitating.
NORD's interest in the controlled substance scheduling of the drug
product gamma-hydroxybutyrate (GHB) relates to our concerns about the
impacts on current research, on the future availability of this drug
for patients with cataplexy, the most severe and debilitating form of
narcolepsy, and on the future of orphan drug research in general.
If GHB is placed on Schedule I or II, current research almost
certainly will stop because of the prohibitive cost of meeting security
and control requirements for the manufacture and distribution of the
drug for research use.
If the clinical research is not completed, no New Drug Application
will be filed with FDA and no safe and effective drug will be available
to patients. We are thus depriving very ill people of their best chance
to live normal lives despite the presence in their lives of an
incurable illness.
Finally, a decision to place GHB on Schedule I has the very real
potential to disrupt the system that has led to progress in the
development of orphan drugs. The reason GHB is under development today
is that a small company, Orphan Medical, responded to FDA's request to
develop the product for the treatment of cataplexy. If we are to hope
for similar success in the future, we must not send a message that if
you agree to take a financial risk and begin development of an orphan
product, the government might later throw you a curve that will prevent
you from ever completing your work.
NORD's roots are with patients and families who worked together for
the enactment of the Orphan Drug Act of 1983, which provides modest
financial incentives to encourage companies to invest in the research
and development of drugs for small patient populations--drugs for which
there are small markets and small potential profitability. In the years
before the Orphan Drug Act was signed into law, fewer than ten orphan
drugs were developed. Now, there are more than 850 designated orphan
drugs; 170 have been approved by FDA. For many patients NORD
represents, this is miraculous progress. But we are not at the end of
the road. Our objective is a solution for every patient and every
family. This is a long course which only can be finished step by step.
We can reach the finish line if the hurdles along the way are
manageable--but not if they are insurmountable.
We are convinced that scheduling GHB as a Schedule I or II
controlled substance would be such an insurmountable obstacle.
it is important to keep in mind that the patient population for GHB
is extremely small. This drug is not the same as one FDA recently
approved, and it is not intended for the same narcolepsy patients. GHB
currently is being studied in a subset of narcolepsy patients, and it
is for this subset that the drug will be indicated. These are
narcolepsy patients who suffer from cataplexy, the most severe form of
narcolepsy. Patients with cataplexy literally can become unconscious
and fall to the floor as a result of an emotional reaction such as
laughter or anger, or when they become excited; during sleep, they
become paralyzed as though in a coma. This means the market for the
drug is very limited, and the ability of a company to make a return on
its research investment is extraordinarily limited. If the cost of that
research were more than doubled, as it would be if the company had to
meet the requirements for making a Schedule I controlled substance, the
possibility of a profit virtually could disappear--as would the
possibility that the drug, once marketed, could be priced so that
cataplexy patients could afford it.
In carrying out its responsibilities under the Orphan Drug Act,
FDA's Office of Orphan Product Development works hard to identify
promising drugs and companies willing to develop them. With GHB, FDA
not only recognized the promise of the drug but also provided funding,
through an Orphan Drug Research Grant, for the first U.S. clinical
trial of the drug. Then, the office took steps to find someone willing
to do the work necessary to get this drug approved. They found one and
only one company.
Early on, FDA recognized the abuse potential of this chemical, and
took steps to try to prevent its being sold through various
nontraditional channels. In doing this, FDA also knew that the only
option for patients was to get an approved prescription drug on the
market as soon as possible. Orphan Medical, a small company in
Minnesota dedicated to the development of orphan drugs, has brought the
research on GHB close to completion, and there is a strong likelihood
that an approved product will be available to patients in the fairly
near future. To take an action now that would impede this process would
be a tragic mistake not only for patients whose lives depend on this
drug, but for the signal such an action would send to other companies.
If other drug companies see that FDA can encourage them to develop an
orphan drug but the government can come along at any later point and
place the substantial research investment of the company in jeopardy,
this would spell disaster for future orphan drug development.
It has been suggested that the pharmaceutical industry is big
business and if one company won't develop a drug, another company will,
or if one drug can't be developed, another can that will serve the same
purpose. For orphan drugs, this is simply not the reality. For patients
with orphan diseases, it is a virtual wonder when a single therapy is
developed. For these patients, choice among drugs is never an option;
for them, it is only a choice of one thing or nothing. For this very
small market, and for these often extremely complicated conditions, it
simply is not the case that drug companies are competing to put
multiple products on the market. For patients with cataplexy, GHB is
their only hope. For the development of GHB, Orphan Medical is our only
hope. Making GHB a Schedule I or II controlled substance destroys that
hope.
We agree with those who say this drug should be controlled. We know
it has been abused, and that abuse cannot go unchecked or unpunished.
We are aware that GHB has been implicated in the heinous crime of rape.
Those who have committed that crime, possibly using GHB or its
precursor chemical Gamma-butyrolactone (GBL) as an agent, must receive
the strongest possible punishment. Severe penalties should also be
imposed on individuals who possess GHB for no reason other than to use
it improperly and illegally. This can be done without placing the drug
under Schedule I and thus jeopardizing cataplexy patients. Controlling
GHB under Schedule III or IV, but providing the authority to the
Department of Justice to levy the maximum penalty for abusing the
drug--the same penalty as for a Schedule I drug provides a deterrent
against criminal use and gives law enforcement officers the ability
both to punish wrongdoers severely.
But probably the most significant action that could be taken right
now would be to get control of the Internet and get the formula for GHB
off of the World Wide Web! In none of the crimes involving GHB or GBL
has the medical version of GHB been used. In every case, either GBL has
been purchased and used in a crime or amateurs have purchased the raw
ingredient and made GHB themselves. This is NOT diversion of the drug
GHB. It is diversion of the raw ingredient and illegal ``manufacture''
of GHB.
As we have done so often in the past, we are ready and willing to
work with this Subcommittee, the Health and Environment Subcommittee,
and the full Commerce Committee to try to solve this problem. We will
happily provide you with any additional information you may need
regarding orphan diseases, the Orphan Drug Act, or the importance of
GHB for patients with cataplexy. We urge you to remember that some
well-intentioned actions, which may seem to be helping some people,
have unintended consequences of harming others. Placing GHB on Schedule
I or II would be such an action. Thank you for the opportunity to
present our views.
______
Department of Health & Human Services
Food and Drug Administration
April 27, 1999
The Honorable Fred Upton
Chairman
Subcommittee on Oversight and Investigations
Committee on Commerce
House of Representatives
Washington, D.C. 20515
Dear Mr. Chairman: This letter is to provide responses of the Food
and Drug Administration (FDA or Agency) to two questions posed at the
March 11, 1999 hearing on ``date rape'' drugs. FDA's witness at the
hearing, Mr. Nicholas Reuter, Associate Director for Domestic and
International Drug Control, Office of Health Affairs, had agreed to
provide responses to these questions for the record.
The first question, posed by Representative Ed Bryant, was to
ascertain the status of Agency review of the recommendation for
scheduling gamma hydroxybutyrate (GHB) under the Controlled Substances
Act.
Jane E. Henney, M.D., Commissioner of Food and Drugs decided in
late March what FDA's proposal for a scheduling recommendation by the
Department of Health and Human Services (DHHS) will be. At this time,
the Agency is finalizing the documentation in support of the
Commissioner's decision. This proposal has been shared with the
National Institute of Drug Abuse for review and comment. We expect the
proposed recommendation to be forwarded to the Assistant Secretary for
Health, DHHS, early next month.
The second question, posed by Representative Ed Whitfield, was
whether a pool of money is available at FDA to fund efforts to educate
young people about the dangers of drugs used in sexual assaults.
FDA does not have such a fund. Nothing in our Congressional
appropriation is specified for education on drugs of abuse. FDA,
however, does undertake educational efforts on using prescription drugs
in a safe manner and we do pursue public education efforts to alert
consumers to dangerous drugs or substances that are being promoted
either as health aids or for recreational use. As an example of these
efforts, enclosed are two FDA Talk Papers, alerting the public to the
dangers of GHB and of gamma butyrolactone (GBL), a GHB analogue.
We hope this information is helpful to the Subcommittee. If we can
be of further assistance, please let us know.
Sincerely,
Melinda K. Plaisier
Interim Associate Commissioner for Legislative Affairs
2 Enclosures
cc: The Honorable Thomas J. Bliley, Jr.
Chairman, Committee on Commerce
The Honorable John D. Dingell
Ranking Minority Member
Committee on Commerce
The Honorable Ron Klink
Ranking Minority Member
Subcommittee on Oversight and Investigations
Committee on Commerce
______
FDA TALK PAPER
FDA Warns About Products Containing Gamma Butyrolactone or GBL and Asks
Companies to Issue a Recall
The Food and Drug Administration is alerting consumers not to
purchase or consume products, some of which are labeled as dietary
supplements, that contain gamma butyrolactone (abbreviated as GBL). FDA
has also asked the companies that manufacture these products to
voluntarily recall them. The agency has received reports of serious
health problems--some that are potentially life-threatening--associated
with the use of these products.
Although labeled as dietary supplements, these products are
illegally marketed unapproved new drugs. Products containing GBL are
marketed under various brand names including Renewtrient, Revivarant or
Revivarant G, Blue Nitro or Blue Nitro Vitality, GH Revitalizer, Gamma
G, and Reinforce. They are promoted with claims to build muscles,
improve physical performance, enhance sex, reduce stress and induce
sleds.
GBL is also known by the chemical names 2(3H)-furanone dihydro;
butyrolactone; gamma-butyrolactone; 4-butyrolactone; dihydro-2(3H)-
furanone; 4-butanolide-2(3H)-furanone, dihydro; tetrahydro-2-furanone;
and butyrolactone gamma.
GBL related products have been associated with reports of at least
55 adverse health effects, including one death. In 19 of those cases,
the consumers became unconscious or comatose and several required
intubation for assisted breathing. Other reported effects included
seizures, vomiting, slow breathing, and slow heart rate. There are
reports of at least 5 children under 18 years of age who have been
injured or who have suffered these kinds of effects.
When taken orally, GBL is converted in the body to gamma
hydroxybutyrate or GHB. GHB is a very potent unapproved drug. It is
currently being investigated under the supervision of doctors for the
treatment of narcolepsy. Because of its serious side effects, GHB
should not be taken unless in the context of these FDA approved
investigations. FDA and the Justice Department have ongoing criminal
enforcement actions against GHB. GBL should not be taken.
Products containing GBL are sold in liquid and powder form. They
are sold via the Internet, in some health food stores, and in some
gymnasiums and fitness centers.
Consumers are advised to dispose of any products of this type in
their possession. If they have experienced adverse health problems from
use of these products, they should promptly contact a physician. FDA
requests consumers and physicians to report adverse events to FDAs
MEDWATCH 1-800-332-1088.
The Trimfast Group, Inc. has agreed to recall the product
Revivarant, 32 ounces of liquid in a plastic bottle, and Revivarant G,
200 grams of powder in a pill bottle. Other companies manufacturing
products containing GBL are being asked by the FDA to voluntarily
recall them.
FDA is considering all potential regulatory actions at its disposal
if products containing GBL are not recalled. The agency will act
expeditiously to protect the public health.
______
FDA TALK PAPER
FDA Re-Issues Warning on GHB
In recent months there has been a resurgence of media and public
interest in the use of gamma hydroxybutyric acid (GHB) for body
building and ``recreational'' uses. Despite renewed claims that it is
legal, GHB continues to be an unapproved and potentially dangerous drug
and cannot be legally marketed in the U.S. Therefore, FDA is renewing
its warning against the use of this product. The following can be used
to answer questions:
GHB is a chemical that has been promoted as a steroid alternative
for body building and other uses for several years. Recently it has
gained favor as a recreational drug because of its intoxicating
effects. Although in the past GHB has undergone clinical testing for
several indications, it has never been approved for sale as a medical
product in this country.
Starting in 1990, FDA began an intense investigation of GHB
distribution after numerous cases of GHB-related illness were reported.
Reported symptoms have included vomiting, dizziness, tremors and
seizures. Many of those injured required hospitalization, and some
deaths have been linked to the consumption of GHB products.
By the end of 1991, FDA and the Department of Justice had taken
enforcement action against several firms and individuals involved in
manufacturing, distributing and promoting GHB. The agency also
instituted an automatic detention policy to prevent products containing
GHB from being imported. These actions--along with embargoes, public
education campaigns and other measures taken by state and federal
authorities--appeared to temporarily diminish the distribution and
abuse of GHB.
Recently, however, there appears to be a resurgence in the abuse of
GHB: virtually all of the products now encountered have been produced
in clandestine laboratories. This increase in use has been accompanied
by an increase in reports of GHB-related injuries, including deaths.
Although some promotion schemes occasionally make unlawful claims
that GHB is a legal drug, it is illegal for any person to produce or
sell GHB in the U.S. FDA's Office of Criminal Investigations is working
with United States Attorneys offices around the country to arrest,
indict and convict individuals responsible for these illegal
operations. FDA, the Centers for Disease Control and Prevention and the
Drug Enforcement Administration are continuing to monitor GHB abuse and
to develop the most effective measures to protect the public health.