SPEAKERS CONTENTS INSERTS
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62–309
2000
CONTROLLED
AND UNCONTROLLED SUBSTANCES USED TO COMMIT DATE
RAPE
HEARING
BEFORE THE
SUBCOMMITTEE ON CRIME
OF
THE
COMMITTEE ON THE JUDICIARY
HOUSE OF REPRESENTATIVES
ONE HUNDRED
FIFTH CONGRESS
SECOND SESSION
ON
H.R. 1530
JULY 30,
1998
Serial No. 151
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Printed
for the use of the Committee on the Judiciary
For sale by the U.S.
Government Printing Office
Superintendent of Documents, Congressional Sales
Office, Washington, DC 20402
COMMITTEE ON THE JUDICIARY
HENRY J. HYDE,
Illinois, Chairman
F. JAMES SENSENBRENNER, Jr., Wisconsin
BILL
McCOLLUM, Florida
GEORGE W. GEKAS, Pennsylvania
HOWARD COBLE, North
Carolina
LAMAR SMITH, Texas
ELTON GALLEGLY, California
CHARLES T.
CANADY, Florida
BOB INGLIS, South Carolina
BOB GOODLATTE,
Virginia
STEPHEN E. BUYER, Indiana
ED BRYANT, Tennessee
STEVE CHABOT,
Ohio
BOB BARR, Georgia
WILLIAM L. JENKINS, Tennessee
ASA HUTCHINSON,
Arkansas
EDWARD A. PEASE, Indiana
CHRIS CANNON, Utah
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JAMES
E. ROGAN, California
LINDSEY O. GRAHAM, South Carolina
MARY BONO,
California
JOHN CONYERS, Jr., Michigan
BARNEY FRANK,
Massachusetts
CHARLES E. SCHUMER, New York
HOWARD L. BERMAN,
California
RICK BOUCHER, Virginia
JERROLD NADLER, New York
ROBERT C.
SCOTT, Virginia
MELVIN L. WATT, North Carolina
ZOE LOFGREN,
California
SHEILA JACKSON LEE, Texas
MAXINE WATERS, California
MARTIN
T. MEEHAN, Massachusetts
WILLIAM D. DELAHUNT, Massachusetts
ROBERT WEXLER,
Florida
STEVEN R. ROTHMAN, New Jersey
THOMAS E. MOONEY,
Chief of Staff-General Counsel
JULIAN EPSTEIN,
Minority Staff Director
Subcommittee on Crime
BILL
McCOLLUM, Florida, Chairman
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STEPHEN
E. BUYER, Indiana
STEVE CHABOT, Ohio
BOB BARR, Georgia
ASA HUTCHINSON,
Arkansas
GEORGE W. GEKAS, Pennsylvania
HOWARD COBLE, North
Carolina
JAMES E. ROGAN, California
LINDSEY O. GRAHAM, South
Carolina
CHARLES E. SCHUMER, New York
SHEILA JACKSON LEE,
Texas
MARTIN T. MEEHAN, Massachusetts
ROBERT WEXLER, Florida
STEVEN R.
ROTHMAN, New Jersey
PAUL J. MCNULTY, Chief
Counsel
GLENN R. SCHMITT, Counsel
DANIEL
J. BRYANT, Counsel
NICOLE R. NASON,
Counsel
MELANIE SLOAN, Minority
Counsel
C O N T E N T S
HEARING
DATE
July 30, 1998
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TEXT
OF BILL
H.R. 1530
OPENING
STATEMENT
McCollon, Bill, a Representative in
Congress from the State of Flordia, chairman Subcommittee on
Crime
WITNESSES
Carter, Joye M., M.D.,
Chief Medical Examiner, Joseph A. Jachimczyk Forensic Center, Houston, TX
Doering, Paul, Professor, Department of Pharmacy
Practice, University of Florida
Farias, Raul,
LaPorte, TX
King, John H., III, Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement Administration,
U.S. Department of Justice
Stevens, Michael,
Detective, Undercover Drug Investigations, Orlando Police Department, Orlando,
FL
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LETTERS,
STATEMENTS, ETC., SUBMITTED FOR THE
HEARING
Carter, Joye M., M.D., Chief Medical
Examiner, Joseph A. Jachimczyk Forensic Center, Houston, TX: Prepared statement
King, John H., III, Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement Administration,
U.S. Department of Justice: Prepared statement
Porrata, Trinka: Article entitled ''Gamma
Hydroxy Butyrate, Old Drug—New Tricks''
Ronald,
Ken, Chief, Congressional Affairs, Drug Enforcement Administration, U.S. Dept.
of Justice: Letter to Dan Bryant, Counsel, Subcommittee on Crime, House
Judiciary Committee, dated August 31, 1998
Stevens, Michael, Detective, Undercover Drug
Investigations, Orlando Police Department, Orlando, FL: Prepared statement
APPENDIX
Material submitted for the record
CONTROLLED AND UNCONTROLLED SUBSTANCES USED TO COMMIT DATE
RAPE
THURSDAY, JULY 30, 1998
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House
of Representatives,
Subcommittee on Crime,
Committee on the
Judiciary,
Washington, DC.
The subcommittee
met, pursuant to call, at 2:08 p.m., in Room 2237, Rayburn House Office
Building, Hon. Bill McCollum [chairman of the subcommittee]
presiding.
Present: Representatives Bill
McCollum, Steve Chabot, Bob Barr, Asa Hutchinson, Howard Coble, and Sheila
Jackson Lee.
Staff Present: Paul J. McNulty,
Chief Counsel; Daniel J. Bryant, Counsel; Nicole R. Nason, Counsel; Veronica
Eligan, Clerk; and Melanie Sloan, Minority Counsel.
OPENING STATEMENT OF
CHAIRMAN McCOLLUM
Mr. MCCOLLUM. The
Subcommittee on Crime will come to order.
In the
104th Congress we addressed the devastating and cowardly crime of drug-induced
rape when we passed the Drug-Induced Rape Prevention and Punishment Act. By
increasing the penalties for the abuse and use of flunitrazepam, I hoped we had
given some measure of protection to young women, particularly college students,
who were unaware of the dangers of drug-induced rape. Despite our best efforts,
however, new drugs which have similar properties as the old flunitrazepam
formula are popping up at nightclubs and college campuses nationwide.
Unfortunately, they are beginning to gain real popularity.
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The
Associated Press reported yesterday that two Penn State students were rushed to
a local hospital after intentionally ingesting gamma hydroxybutyrate, popularly
known as GHB. The director of the University's Office of Student Health Services
was particularly upset, since Penn State's students are warned about potential
date rape drugs at orientation. GHB is one of the drugs discussed at that
orientation, and yet the message clearly did not get
through.
In its liquid form, GHB is sold by the
capful for about $10. It can also be ingested in powder form. Either way, it
dissolves quickly in alcohol and can take effect within 15 minutes. GHB can
cause vomiting, dizziness, tremors and seizures, and victims frequently lapse
into unconsciousness and require hospitalization. Although it was banned in the
United States by the FDA in 1990, the Drug Enforcement Administration has
received reports of GHB being used to incapacitate victims before the commission
of a sexual assault.
How then are young students
getting their hands on a drug which is banned in the United States? The answer
is the Internet. Once again, the Internet is being manipulated by those who
would take advantage of its wide accessibility and protections of
anonymity.
The instructions for concocting GHB
abound on the web, which is extremely dangerous since the drug can be
manufactured at home with a few simple products available from hardware stores
and specialty foods stores. Some sites even offer the visitors an opportunity to
purchase any items which they may not be able to obtain locally. Unfortunately,
this information is usually inaccurate and misleading. One particularly sinister
web site even noted that GHB was very effective as a precursor for sex since it
lowered a woman's inhibitions. To me this sounds like a direct invitation for
date rape.
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Like
flunitrazepam, I am certain that GHB does have some valuable medical uses. I am
aware that the FDA allows certain physician-supervised GHB studies to continue
in the United States, and we certainly do not want to overreact to the
issue.
The same is true of other drugs which we
may be discussing here today, such as the drug ketamine hydrochloride, known on
the street as ''Special K''. The abuse of ketamine is clearly on the rise. It
has been coupled in the media with the crime of drug-induced date rape, but
little evidence exists thus far to associates it with that hideous act. There
may be persons who could benefit greatly from the use of GHB or ketamine, and,
as I always hope, this hearing will provide us with some opportunity to learn
more about these drugs.
We all know rape is a
crime of power in which the aggressor tries to exert control over the victim
through the sexual assault. It is one of the worst crimes which can be
committed, and yet, astonishingly, the criminal element in our society has found
a way to make it even worse. Rape becomes even more cowardly when the victim is
incapacitated through the surreptitious use of
drugs.
Today we will hear some tragic stories
about the misuse of GHB and ketamine. We will also discuss the abuse of
flunitrazepam in the United States since the passage of our legislation in the
last Congress. I certainly hope that the DEA has some good news to offer
regarding what effects the passage of that act had on the incidents of
drug-induced rape.
I want to particularly thank
the gentlewoman from Texas, Ms. Jackson Lee, for her unyielding commitment to
this important issue. She is a dedicated member of this subcommittee, and I know
this hearing is very significant for her.
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I
also appreciate all of the witnesses being here today, to help us think through
what response would be the most effective and appropriate for Congress to take
to resolve this continued and apparently very aggressive
problem.
Miss Jackson Lee, would you like to make
opening remarks?
Ms. JACKSON LEE. I
thank you very much, Mr. Chairman. And first of all, let me thank you for
working so evenhandedly and so closely with me on this particular legislation,
and particularly the dedication of your staff, Paul McNulty, and the willingness
that you expressed in holding this hearing
today.
The legislation we are introducing here
today has a great personal importance to me. We are here to discuss legislation
which focuses on the use of controlled and uncontrolled substances to commit
date rape. Violence against women is a social evil that we must
address.
Drug facilitated date rape is just one
manifestation of this complex issue. As legislators, parents, brothers, sisters,
and aunts and uncles, mothers and fathers, we must work to protect our loved
ones from the insidious harm resulting from the use of these misused
drugs.
Like you, Mr. Chairman, I recognize that
there are those who will argue for the medical prowess, if you will, of both the
drugs we are concerned with today. But I hope this hearing will help explore
those questions, and that we will have a full understanding and we will come
down on the side of protecting the innocents.
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This
issue, and this legislation, is a result of a tragedy which has been carried out
in many States and cities in our country. The bill I have introduced, H.R. 1530,
is named for a young woman, Hillory Janine Farias, from LaPorte, Texas, who died
on August 5th, 1996 at age 17 from an overdose of GHB. I think it was this
picture of her on the television screen, showing her as a lovely young teenage
girl, that got my attention that evening.
On the
night she died, Hillory and two girlfriends went to a dance club. Witnesses said
that Hillory consumed only soft drinks while at the club. Not long afterwards,
she complained of feeling sick and having a severe headache. A friend took her
home and she went to bed. The next morning Hillory's grandmother discovered her
lying in bed unconscious and not breathing. She rushed her to the hospital, but
Hillory never regained consciousness.
Hillory
Farias was going to be a senior at LaPorte High School. According to those who
knew her, Hillory was neither a drinker nor drug user. In fact, she was a
clean-cut girl, a model student, a varsity volleyball player, and I remembered
that most, and a talented overall
athlete.
Unfortunately, this story is the not so
unusual. The Los Angeles County Sheriff's Department recently successfully
prosecuted a man and two accomplices for drugging and raping 10 women and
poisoning six others. Numerous photographs depicting sex between the men and
unconscious women were found in the defendant's van. On New Year's of 1996, 30
to 50 people collapsed from ingesting a GHB analog. Luckily, all of them
received medical attention and survived, including a 17-year-old who suffered a
heart attack.
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The
DEA has been working on placing this drug on Schedule I of the Controlled
Substances Act at the Federal level. Many of our districts have already assigned
GHB to Schedule I or II, including Georgia, Rhode Island, Illinois, Alaska,
Louisiana, Tennessee, Hawaii, and Nevada.
After
the death of Hillory, in my own State, I decided something must be done at the
Federal level to combat the use of these dangerous drugs as a tool of date rape.
H.R. 1530, the Hillory J. Farias Date Rape Prevention Drug Act, directs the
Attorney General to schedule GHB as a Schedule I drug and ketamine as a Schedule
II drug.
It also directs the Attorney General to
establish programs throughout the country and 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 as well
in using it at all.
Both GHB and ketamine have
been used as date rape drugs, rendering the victim helpless to defend herself
against the attack and even obliterating memory of the attack. It is responsible
for as many as 60 admissions in the past 6 months to emergency rooms in Houston
alone. To date, there have been 16 deaths officially attributed to GHB use.
However, many more deaths have undoubtedly gone without notice, since GHB is not
part of a standard toxicology screen.
Although
GHB is not produced legally in the United States, much of it is either smuggled
across United States borders—and by the way, Mr. Chairman, there are 16 sites in
Mexico that are now making these drugs—or else is illegally created in home labs
and bathtubs by those who can easily access this date rape drug recipe through
the Internet.
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Scheduling
a drug on the Federal Controlled Substances Act allows prosecutors to all punish
anyone who uses scheduled drugs in any sexual assault crime to suffer penalties
under the Drug-Induced Rape Prevention and Punishment Act of 1996. If we fail to
schedule GHB as a level I or level II drug covered by the Controlled Substances
Abuse Act, drug analogs of GHB, which are those chemical substances which have
almost exactly the same chemical makeup as the drug itself, will take its place
on the market, leaving law enforcement without legal
recourse.
Finally, my legislation, unlike that of
my colleague, Representative Stupak, will ensure that those who illegally
possess and/or produce GHB, or any closely-related compound with the same
effects, can be and will be prosecuted to the full extent of the
law.
When we balance the pros and cons of this
legislation, and I know as a lawmaker and a parent of two children that there is
always more than one way to look at an issue, we can only conclude that we do
whatever is necessary to stop both the illegal production and illegal use of
this dangerous drug.
My legislation also
schedules ketamine in Schedule II of the Controlled Substances Act. And as you
said, ketamine is used as an anesthetic, primarily for veterinary use. It will
be able, under Schedule II, to be used properly. Ketamine is only available to
physicians and not commonly sold as an illicit drug, but is only scheduled in
several States. And like GHB, ketamine also is used as a tool of sexual assault
against unsuspecting girls and women. And like GHB, it is equally as important
to schedule that drug federally so that we can limit the abuse of this drug.
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I
believe we must do whatever we can to stop the abuse of these harmful drugs. I
hope my colleagues will support this legislation and our efforts to protect
girls and women from the violent crime of sexual assault through these date rape
drugs. I would really prefer to have Hillory alive today, but I hope we can do
something in tribute to her life and that of her family, and young girls and
young boys across the Nation.
Mr. Chairman, I
thank you very much for the holding of this
hearing.
[The bill, H.R. 1530,
follows:]
105TH CONGRESS
1ST SESSION
H. R.
1530
To schedule Gamma y-hydroxybutyrate in schedule I of the Controlled
Substances Act and to schedule Ketamine in schedule II of such Act and for other
purposes.
IN THE HOUSE OF
REPRESENTATIVES
MAY 5, 1997
Ms. JACKSON-LEE of Texas
(for herself, Ms. MCKINNEY, Mrs. MEEK of Florida, Mrs.
TAUSCHER, Ms. KILPATRICK, Mrs. LOWEY, Mrs.
MORELLA, Ms. VELÁZQUEZ, Ms. MILLENDER-MCDONALD,
Mr. BISHOP, Mr. PALLONE, Mr. WEXLER, Ms.
STABENOW, Ms. MCCARTHY of Missouri, Ms.
ROYBAL-ALLARD, Mr. BENTSEN, Ms. DELAURO, Mr.
HINOJOSA, Mr. RODRIGUEZ, Mr. REYES, and Mr.
SERRANO) introduced the following bill; which was referred to the
Committee on Commerce, and in addition to the Committee on the Judiciary, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
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A
BILL
To schedule Gamma y-hydroxybutyrate in schedule I of the Controlled
Substances Act and to schedule Ketamine in schedule II of such Act and for other
purposes.
Be it enacted by the Senate and
House of Representatives of the United States of America in Congress
assembled,
SECTION 1. SHORT
TITLE.
This Act may be cited as the ''Hillory J.
Farias Date Rape Prevention Drug Act''.
SEC. 2. DRUG
SCHEDULING.
The Attorney General shall schedule Gamma
y-hydroxybutyrate in schedule I of the Controlled Substances Act (21 U.S.C. 812)
and shall schedule Ketamine in schedule II of such Act.
SEC. 3. EDUCATION AND
DRUG ABUSE PREVENTION.
The Attorney General shall
establish programs throughout the United States and 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.
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Mr.
MCCOLLUM. Thank you, Ms. Jackson
Lee.
Does anyone on this side wish to make an
opening statement?
Mr.
Hutchinson.
Mr. HUTCHINSON. Thank you,
Mr. Chairman. I will try to be brief, but I do commend you for holding this
hearing, and there have been a couple of recent Arkansas cases that dramatize
the serious nature of the crimes in question and the difficulty of
prosecution.
In both cases that I am thinking of,
memory was a very serious problem for the prosecutors in handling the case. In
one case six women testified that they had been drugged and raped by the same
man. Samples taken during subsequent physical exam proved crucial to the case,
which was otherwise hindered by the victims' lack of memory as a consequence of
the drug.
The many legal and emotional problems
faced by victims and the difficulties associated with prosecution point up the
need for serious penalties for mere possession. The use of drugs such as
Rohypnol, which was used in the Arkansas cases, make these cases even more
difficult because of the memory loss. Like the women from Arkansas, victims lose
control of their faculties and cannot remember the events leading up to the
rape.
Another Arkansas case was successfully
prosecuted because the rapist videotaped his encounters, and the tapes were
obtained and used by prosecutors to demonstrate the effects of the drug and the
subsequent sexual assault. Few victims are able to present such convincing
evidence, and that is why, Mr. Chairman, it is so important that the mere
possession of such drugs carries severe penalties. In the case that I just
mentioned, the victim would not even have been identified without the discovery
of the videotape.
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But
it is equally important that we extend our discussion of date rape drugs to
others that the chairman has mentioned, not just Rohypnol but GHB and ketamine
as well. Neither of these drugs is currently controlled or scheduled in the
United States, and this I hope will be discussed during this
hearing.
So I look forward to the testimony
today. I thank you for this hearing, and I think we also ought to look at
greater education and preventive efforts on our college campuses because of the
dangerous nature of these drugs. Thank you, Mr.
Chairman.
Mr. MCCOLLUM. Mr.
Coble.
Mr. COBLE. Briefly, Mr.
Chairman, I thank you for having this hearing. Schedule I may or may not be the
appropriate course to pursue. Hopefully we will know more about this after this
hearing. If in fact the drug at issue does have some value for medicinal
purposes, and I have been told that studies are underway to either confirm or
refute that, I think we need to be careful in charting this course toward
Schedule I, given the possibility of that.
I
thank the chairman.
Mr. MCCOLLUM.
Thank you, Mr. Coble.
Mr. Chabot.
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Mr.
CHABOT. Thank you, Mr. Chairman. I also will be brief. I want to
thank you for holding this important hearing. I share your concern about the
dangers of these drugs, and I share your concern for the safety of women who
have been victimized by these dangerous
drugs.
These date rape drugs present a real
danger to women across the country. In fact, there is currently a case in my
hometown of Cincinnati where a man allegedly used date rape drugs to attack at
least eight women. It is vital that we take strong steps to protect them and
women like them from these deranged acts.
Mr.
Chairman, as you know, Federal, State and local law enforcement agencies, drug
abuse prevention organizations, independent studies and media reports have
raised serious concerns about the trafficking of controlled substances,
including, in particular, date rape drugs from Mexico. While Rohypnol has been
banned in the U.S., many other dangerous controlled substances have taken its
place.
For example, Texas law enforcement
officials, in undercover videotape, have discovered that since Rohypnol was
banned, Mexican pharmacies have been offering other drugs, such as Rivotril
substitutes. While this problem is most notable in communities along the
U.S.-Mexican border, it impacts communities well outside the Southwest. A study
in Laredo found that residents of 39 States crossed the border and returned to
the U.S. with a variety of drug products.
Mr.
Chairman, Congress has and is continuing to fight the war on drugs to protect
our children, our communities and our families. It is important that we
highlight the danger of these drugs and take significant steps to stop them. I
know that you share this concern, and I appreciate your leadership and
commitment in stopping these dangerous drugs.
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Mr.
MCCOLLUM. Thank you.
Mr. Barr, do you
have any opening comments?
Mr. BARR.
Just to the chairman for convening these hearings. I would like to also thank my
colleague from Texas, Ms. Sheila Jackson Lee, for introducing the legislation
and providing a great deal of support for moving these hearings
forward.
As all of us here know, we began looking
at this matter a couple of years ago, and while there has been some progress
made with regard to some changes in the drug Rohypnol, it still remains a
serious problem.
I am looking forward to the
testimony today and to continuing to remain in contact both with our colleagues
that support legislation to address this, and I count myself among that group,
but also to continue to hear from our colleagues at DEA, which has spent a great
deal of time over the past year in conducting a very extensive study of this
matter; and also maintaining contact with those in the industry itself, which I
think are, in large part, taking a very responsible attitude toward trying to
address these problems and, where possible, to make changes to the composition
of and the properties of some of these drugs so that it makes their unknowing
ingestion by other people much less likely.
And
while all of these things are important, the problem remains for us that there
are innocent people being harmed and, in some instances, killed in this country
through these sorts of drugs such as GHB. So I think through these hearings and
the additional work that we will be doing, I have every confidence that we will
be able to craft a piece of legislation that follows on the legislation that we
passed in the last Congress that continues to fine-tune the concerns that we
have to provide for whatever level of criminal penalties are appropriate based
on sound scientific and medical analysis.
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This
hearing today, particularly focusing on the legislation by Ms. Jackson Lee, I
think is very appropriate and will be very, very beneficial, and I commend the
chairman for holding these hearings.
Mr.
MCCOLLUM. Thank you, Mr. Barr.
We are
now ready for our witnesses, and the subcommittee's first witness is Mr. Raul
Farias, I believe is the correct pronunciation. He may come forward and take a
seat.
Mr. Farias is from LaPorte, Texas. He is
the uncle of Hillory Farias, who, as you heard from Ms. Jackson Lee, was
tragically killed by the date rape drug known as GHB. Mr. Farias and his wife,
Maria, are the proud parents of four children. They have been active in speaking
out against the drug GHB since Hillory's death and have established a
scholarship in memory of Hillory. Commendably, they have turned their personal
tragedy into a commitment to educate communities on the dangers associated with
GHB.
Our second witness is Dr. Joye Carter. Dr.
Carter is the chief medical examiner of Harris County. She served as the chief
medical examiner for the District of Columbia for 4 years, while also serving as
assistant clinical professor in the Department of Pathology at Howard University
and as associate professor in the Department of Forensic Science at George
Washington University.
Dr. Carter is currently
assistant clinical professor in the Department of Pathology at Baylor College of
Medicine and assistant clinical professor in the Department of Pathology at the
University of Texas. She has been published in many medical journals over the
years and is a recognized expert in pathology. Dr. Carter received her doctorate
in medicine from Howard University.
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Our
next witness on this panel is Detective Michael Stevens from the Orlando Police
Department's Drug Enforcement Division. Detective Stevens has been extensively
involved in undercover investigations of the Rave drug scene and has conducted
training courses regarding the Rave trend and designer drugs for the Orange
County, Florida Corrections Department and the Florida Department of Probation
and Parole.
He has testified before the Tampa,
Florida City Council regarding Rave activities, designer and club drugs, as well
as groups selling and distributing them. He has received an Orlando Police
Department Award of Commendation for his work associated with having ketamine
classified as a controlled substance in the State of
Florida.
Detective Stevens is a graduate of the
Brevard County Law Enforcement Academy and served for more than 5 years in the
United States Marine Corps as a military police officer. I have to especially
say I am proud of the fact he is from my home,
Orlando.
Our fourth witness is Mr. Paul Doering,
distinguished service professor in the Department of Pharmacy Practice at the
University of Florida College of Pharmacy. Professor Doering is also co-director
of the statewide Drug Information and Pharmacy Resource Center. He is a frequent
speaker to on-campus groups, helping to educate college students about the risk
of using drugs for recreational
purposes.
Professor Doering has been recognized
four times as Teacher of the Year for the College of Pharmacy, and in 1995 was
named to his present position, making him the first distinguished service
professor in the College of Pharmacy's history to be awarded this high
honor.
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Professor
Doering received his B.S. Degree in pharmacy from the University of Florida and
his M.S. in clinical pharmacy. It is a distinct pleasure to welcome a fellow
Gator.
You have one constituent and I only have
one constituent, but I did go to the University of Florida so I claim two of
panel. You can claim Dr. Carter and we will be even. How about
that?
Ms. JACKSON LEE. Yes, and Mr.
Farias.
Mr. MCCOLLUM. Let me say I
first of all want to welcome each of you here. Your complete statements will
appear in the record, without objection, and I would request that you summarize
for us, hopefully as briefly as 5 minutes or so, as we have limited time this
afternoon.
Secondly, I want to say before you
commence that I am grateful, as all the committee members are, for your
understanding today. We moved this hearing, if anyone here in the room didn't
know, from this morning to this afternoon because of the funeral services for
one of the police officers slain here in the Capitol, Detective Gibson, and we
really appreciate your indulgence in that
regard.
I will go in the order in which I
introduced you, so we will start Mr. Farias. Did I get that
right?
Mr. FARIAS. Farias.
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Mr.
MCCOLLUM. So I actually had that right. So, Mr. Farias, please
proceed.
STATEMENT OF RAUL FARIAS, LaPORTE,
TX
Mr. FARIAS. First, I want to thank
the chairman, Bill McCollum, and Ranking Member Charles Schumer for holding this
hearing on this use of controlled substances used to commit date rape. I would
especially like to thank Congresswoman Sheila Jackson Lee of Houston, Texas, for
sponsoring H.R. 1530, in which, with the permission of my family, she most
appropriately named the bill the Hillory J. Farias Date Rape Prevention Drug
Act. I would like to thank her and her entire staff for their tireless efforts,
for bringing this legislation forward. We appreciate that very
much.
Again, my name is Raul Farias, uncle of
Hillory Farias, who was murdered August 5th, 1996, by a date rape drug called
GHB which was slipped into her Sprite.
The week
before Hillory's death she had attended a volleyball camp held at Southwest
Texas State University at San Marcus, Texas, sponsored by the University of
Texas. This was the first time Hillory had ever gone away by herself. It was a
week-long camp, and Hillory got homesick pretty quickly. She started calling two
or three times a day, and then we called her also, so it was a very difficult
time for all of us.
Saturday, my brother, my
mother and my father went to go see her perform, and I remember my brother Rubin
telling me that as soon as Hillory saw them she broke into tears. It was pretty
evident that she missed everyone.
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When
Hillory returned on August 4th, my family went to my mother's house to go see
how she was doing. My son, 5 years of age, and my daughter, 3 years of age at
the time, really had missed her. Hillory loved my children in a very special
way. She always made time to spend time with them almost every
day.
And our visit that Sunday was about 2 hours.
We played, we talked, then it was time for us to go back home. We all gave
Hillory a kiss good-bye. I was the last to leave. I leaned over and I told her
that I loved her and I would see her the following
day.
I was real happy for her. She came back with
a great outlook for her senior year. She had won a lot of awards at camp. She
was very proud. I had never seen her so happy and confident, and she told me
that she was ready for the upcoming volleyball season and was praying for a
scholarship, hopefully from the University of Texas. She was looking forward to
the homecoming, the prom, graduation, and her first date. She was full of
life.
The next day, August 5th, I was at work
when my mother, Hillory's grandma, called. She could not wake up Hillory. My
mother sounded rather shaky. Then mom told me she was cold, and I told her to
call 911. Then she hung up the phone. And at that moment I knew Hillory was in
trouble. I had a gut feeling that Hillory had just
died.
I drove from work to the hospital. It was a
30-mile trip, and all the way up there I prayed to God to spare her life and
take mine. When I arrived, my brother met me outside and he told me that Hillory
didn't make it. I couldn't believe it. The previous day I had just told Hillory
I would come by and see her. Now, I am seeing her lying peacefully and
breathless. She looked like she was just sleeping, and I told the nurses to come
and revive her because she looked fine, and the nurses just told me that she was
gone. She's gone.
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The
baby that came into our lives 17 years ago, the one that used to cry for me when
she was in trouble, I wasn't there to protect her. I wasn't there to protect her
from the evil that took her life away.
This all
happened the night she came back from volleyball camp. Hillory and a friend went
to a night spot, it was a teen night, to see all her friends from high school.
It was like a school gathering before school started. Hillory came home around
midnight. Grandma was waiting for her, as usual, and she told Hillory to go
brush her teeth and go to bed for the following day, and Hillory complained of a
headache. She took some aspirins, went to sleep and never woke up. Someone had
slipped GHB into her Sprite. She was
murdered.
Hillory never drank alcohol, never
smoked, and was drug free. The investigation has proved all of this, and what is
so honorable about the investigation, the one thing that stood out in the
investigation is that Hillory's character was recognized by all that were
interviewed. We already knew Hillory was special, but to hear from hundreds of
other people, it was just something very special and something very meaningful
to the family.
Hillory will never get the
scholarship she dreamed of. She will never go to the prom. She will never
experience her first date. She will never graduate. My children, every night
they pray to God so God can play volleyball with her so she won't be alone. I am
just telling you how I am feeling. I can't even start telling you how Hillory's
grandparents are feeling. They are the ones that raised
her.
Yes, our family has been through a very
difficult time, but what happened to Hillory also has touched the community, the
Nation and the world. Hillory's death tells the story of what is wrong with this
world today. The alleged killer to have done this to Hillory is one of her best
friends.
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We
teach our children to be aware of strangers. Well, we have gotten to the point
to where we cannot trust anyone, including friends or even family.
Accountability has gone away from our society. Children are being raised with no
morals. Our Nation has followed the same path. It is one thing to be a willing
participant of drug use, but it is another when you are participating
unwillingly or unknowingly.
Please put this bill
into action. We need to protect our youth; need to protect our daughters, sons,
nieces and nephews, and hold people accountable for their actions, especially
when it comes to defenseless rape and
murder.
Before I close, I know there are some
people that want this drug to be a Schedule III, and the problem with that is
the damage has been done. You can get the information, the recipe on how to make
GHB, on the Internet. Therefore, if it becomes Schedule III, then no one will
ever be held accountable for any type of murder or defenseless
rape.
And I do want to thank you very much for
having me here, and I leave this up to God's hands. Thank
you.
Mr. MCCOLLUM. Thank you very
much, Mr. Farias, for telling us a very touching and very emotional story
through your own testimony.
Dr. Carter, you are
recognized.
STATEMENT OF JOYE M. CARTER, M.D., CHIEF MEDICAL EXAMINER,
JOSEPH A. JACHIMCZYK FORENSIC CENTER, HOUSTON, TX
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Ms.
CARTER. Good afternoon, Mr. Chairman and members of the Subcommittee
on Crime. As a physician and forensic pathologist, my responsibilities include
investigating deaths due to natural and unnatural causes, as well as promoting
social change and improved health care through information gained by close
examinations of the dead body. And I consider it an honor to speak on behalf of
the dead, who can no longer tell their
story.
Substance abuse is a very broad category
encompassing addiction to alcohol, prescription drugs, illicit drugs, and
naturally occurring chemicals such as sugar, caffeine and fats. It is the
leading cause of death when we investigate accidents, suicides, homicides, and
even natural cases.
In the Harris County
experience, 25 percent of all accidental deaths are due to drug ingestion. The
most common drug, of course, is ethyl alcohol. Other drugs detected with
frequency in the dead body include cocaine, marijuana, codeine, morphine,
methadone, PCP, also things such as aspirin and Tylenol. Other drugs are
detected with less frequency. Those include ketamine, inhalants, which can
encompass many household chemicals, LSD, and date rape drugs. I would like to
focus my comments on this latter category of abused
substances.
Date rape drugs is a very complex
entity which has been highlighted by the media in recent years. The two most
notable drugs, gamma hydroxybutyrate, known as GHB, and Rohypnol are the most
frequently discussed. Rohypnol is in the category of benzodiazepines. Other
drugs also in that category come under Valium, Atavan, Xanax, Halcion or
Librium. Other preparations which should be considered are Benadryl, even things
such as Nytol, which can be purchased over the counter. The ''date rape'' phrase
suggests these drugs are unknowingly consumed and a sexual encounter takes place
after the victim has been intoxicated.
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GHB
is in the category of a CNS, or central nervous system depressant. Its first
phase is to reduce inhibitions, just like alcohol. The common denominator of the
different drugs I previously mentioned is they interfere with memory, some even
cause amnesia, thereby making sexual assault all the more difficult to
document.
The Harris County Medical Examiner's
Office set a precedent in 1996 when a case was ruled homicide due to gamma
hydroxybutyrate toxicity. You have already heard about the life of Hillory
Farias, certainly well-known in southeast Texas. She had gone to a dance club.
She complained of a severe headache and, indeed, she never woke
up.
The medical examiner was notified of a sudden
death in a teenager, and Ms. Farias' family had made a conscious decision to
give the gift of life. The diagnosis working at that point had been a sudden
death due to an accidental hemorrhage in the brain. At autopsy no abnormalities
were found. Repeated drug testing finally revealed the presence of GHB in her
blood and in the fluid from the eye. It took us 2 months to detect this
chemical.
The investigation, indeed, did not
suggest any experimentation previously with drugs. The blood level was low, by
our forensic standards, but we must take into consideration the half-life of GHB
is as little as 1 hour. It may disappear from the body fluids in 12 hours. Our
tests were performed on urine.
GHB can be
naturally occurring but also is easily manufactured by simple chemicals which
are available at your local hardware store. You don't need a degree in chemistry
to manufacture this drug. It is, indeed, sold on the black market. The
instructions are, of course, listed on the Internet. It was originally marketed
to health food stores for body builders and as a diet and sleeping aid.
Page 29 PREV PAGE TOP OF DOC
Its
central nervous system activity, that of a depressant, and numerous complaints
that ranged from nausea to seizure activity and coma were recognized, and in
1990 the FDA removed it from public consumption. It is important to recognize
that there is no known antidote for GHB
toxicity.
Besides the nomenclature of date rape,
these drugs should also be considered as something that is now being abused by
young people, particularly high school and college age. These drugs in the
category of date rape can produce hallucinogens and certainly depress the
central nervous system, more severe when used with alcohol. The effects are dose
and time related.
There are very few written
procedures to document GHB in a person's blood. When used for recreational
purposes, the person can expect perhaps to have a high, to feel good, euphoria,
increased libido, especially dangerous with date rape, weight control or steroid
supplement.
Problems exist in documenting the
presence of date rape drugs in the body. First of all, these drugs are not
included in the routine drug screening panel. The scene of death or injury must
be thoroughly investigated because GHB can be found mixed with other substances,
such as water, soft drinks, ice tea, even mouthwash. Laboratory analysis is
critical in documenting the presence of GHB. What is more important is that with
the potential for amnesia or memory distortion, date rape may be difficult to
prosecute due to the passage of time and the need to document the presence of
the drug in the victim's system.
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Congresswoman
Sheila Jackson Lee introduced the Hillory Farias Date Rape Prevention Drug Act
in May 1997 for purposes of including GHB in Schedule I of the Controlled
Substances Act, and I do support this. This is important for those that
investigate cases of substance abuse in death, due to the complex nature of
detecting the chemical in the body fluids. It would certainly remove a
misdemeanor offense charge and place it in the same category for possession of
narcotic substances. It is important to have a means available for those persons
who suspect they have fallen victim to date rape, and allow for more timely and
selective drug detection methods.
I want to
emphasize date rape drugs do cover a broad category, and I have focused on only
one in the interest of time.
Since GHB and other
drugs may produce an altered state of consciousness and memory loss, that victim
of sexual assault becomes an unwilling participant in this criminal activity.
There is no doubt there is some limited activity under the medical value for
GHB, but there is also limited activity for cocaine and morphine, yet these are
Schedule I.
I conclude my remarks at this time
and I thank you for your interest in this
topic.
[The prepared statement of Dr. Carter
follows:]
PREPARED STATEMENT OF JOYE M. CARTER, M.D., CHIEF MEDICAL
EXAMINER, JOSEPH A. JACHIMCZYK FORENSIC CENTER, HOUSTON, TX
Page 31 PREV PAGE TOP OF DOC
SUMMARY:
The
category of Date Rape drugs is very broad. The media frequently discusses
Gamma-hydroxybutyrate and Rohypnol, but other drugs must be considered such as:
alcohol, Benadryl and over-the counter medications that contain
diphenhydramine.
A common feature of ''Date
Rape'' drugs is their ability to be ingested without knowledge and the
inducement of an altered state of consciousness or memory loss. These drugs are
not easily detected nor considered regularly as the causative agent in a death
or sexual assault. Further, these drugs are not all categorized as level one or
two under the current Controlled Substance
Act.
In addition to being utilized in sexual
assaults many of these ''Date Rape'' drugs are being abused with alarming
frequency among young people.
| Office of the Medical Examiner of Harris County, |
| Joseph A. Jachimczyk Forensic Center, |
| Houston, TX, July 27, 1998. |
Hon.
HENRY J. HYDE, Chairman,
Committee on the
Judiciary,
House of Representatives, Washington,
DC.
CHAIRMAN AND MEMBERS OF THE
SUBCOMMITTEE ON CRIME: Thank you for the opportunity to address our national
legislators on such an important issue as substance abuse.
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My
name is Dr. Joye M. Carter, and I am a forensic pathologist and the Chief
Medical Examiner for Harris County, Houston, Texas. I am a private citizen and
do not represent any federal programs or subcontractors
awardees.
As a physician and forensic pathologist
my responsibilities include investigating deaths due to natural and unnatural
causes, as well as promoting social change and improved health care through
information gained by close examinations of the dead body. I consider it my
honor to speak on behalf of the dead, who can no longer tell their
story.
Substance abuse is a broad category;
incorporating addictions to alcohol, prescription drugs, illicit drugs and
natural occurring chemicals. Substance abuse is a leading cause underlying motor
vehicular accidents, suicide, homicides and yes, natural
deaths.
In the Harris County, Texas experience
approximately 25% of all accidental deaths investigated by the medical
examiner's department are due to overdosing on alcohol and other drugs. The most
frequently detected drug is ethyl alcohol. Alcohol has been recognized world
wide as the most common drug involved in violent deaths as well as naturally
occurring deaths such as cardiovascular disease, liver failure, various types of
cancer, infectious process and malnutrition. Other drugs detected in the dead
with frequency are Cocaine, Marijuana, Codeine, Morphine (Heroin), Methadone,
Salicylates, Acetaminophen, PCP, Benzodiazepines, anti-depressants. Other drugs
are detected with less frequency in the dead bodies, as well as those
individuals arrested on suspicion of driving while intoxicated. These drugs
include Ketamine, inhalants, LSD and Date Rape Drugs. I would like to focus my
comments on this latter category of abused substances. Date Rape Drugs is a
complex entity which has been highlighted by the media in recent years. This
category includes Gamma hydroxybutyrate (GHB) and Rohypnol as the most
frequently discussed, but also the other benzodiazepines, which may be
recognized by brand names of Valium, Ativan, Xanax, Halcion or Librium. Other
preparations, such as Benadryl or even Nytol, may be considered in the ''Date
Rape'' category. Please be mindful that alcohol may be consumed without
knowledge. The Date Rape phrase suggests that these drugs are unknowingly
consumed and a sexual encounter takes place after the victims have become
intoxicated. The common denominator of the different drugs previously listed is
that they interfere with memory, some even cause amnesia, thereby, making a
sexual assault all the more difficult to document.
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The
Harris County Medical Examiner Office set precedent in 1996 when a case was
ruled homicide due to Gamma-hydroxybutyrate (GHB)
toxicity.
The death of Hillory Janean Farias is
well known in Southeast Texas. Ms. Farias was by all accounts a healthy and
well-adjusted seventeen years old girl about to enter her senior year of high
school. She had gone to a teen dance club where she may have consumed a soft
drink. Upon returning home she complained of a severe headache and went to bed.
She never woke up. The Medical Examiner's Office was notified of a sudden death
in a teenager and the family had made a conscious decision to donate her organs.
The working diagnosis had been cerebral hemorrhage secondary to aneurysm. At
autopsy, no abnormalities were found. Repeated drug testing finally revealed the
presence of GHB in her blood and ocular fluid. The investigation into Ms. Farias
death did not demonstrate any willing experimentation with drugs. The detected
blood level was low, by forensic standards, however, the metabolism and
half-life of this drug should be taken into
consideration.
GHB (gamma hydroxybutyrate) is a
naturally occurring substance found within our bodies and also is easily
manufactured by simple chemicals, which are available at the local hardware
store. No degree in chemistry is needed to produce ''black market'' GHB; in fact
the instructions are available over the Internet. GHB was originally marketed in
health food stores to body builders and as a diet and sleeping aid. Its central
nervous system activity, that of a depressant and numerous complaints of
symptoms ranging from nausea to coma were recognized. In 1990, the Food and Drug
Administration removed it from public consumption. The death of Hillary Farias
is now one of many examples of the dangerous properties of GHB.
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Besides
the nomenclature of ''Date Rape'' these same drugs should be considered as
abused substances from the standpoint that they can act as central nervous
system depressants and mild hallucinogens in individuals. The effects are dose
and time related. Gamma hydroxybutyrate and other drugs in this category have
been detected in persons admitted to area hospitals for unusual behavior or coma
induced states. Numerous cases are cited in the recent literature of abuse by
purposeful ingestion of the compound either in liquid form, mixed or consumed as
a powder. If used as an abused substance, the findings might include getting a
''high'', increasing libido, weight control by suppressing the appetite and
steroid supplement for bodybuilding.
Problems
exist in documenting the presence of date rape drugs in the body. First of all
these drugs are not included in the routine drug screen panel. The scene of
injury or death must be investigated thoroughly because GHB in particular has
been found in spring water bottles, ice tea and even mouthwash. Both GHB and
Rohypnol used to be white powder or tablet form. Now manufactures of Rohypnol
include a blue dye, at least in this country. Laboratory analysis is critical in
documenting the presence of GHB since we know that it also occurs naturally.
What is more important is that with the potential for amnesia or memory
distortion, date rape may be difficult to prosecute due to passage of time and
the need to document the presence of the actual drug in the victims
system.
Congresswoman Shellie Jackson Lee
introduced the Hillory J. Farias Date Rape Prevention Drug Act in May of 1997
for purposes of including Gamma-hydroxybutyrate in Schedule I of the Controlled
Substance Act. This is important for those that investigate cases of substance
abuse and deaths due to the complex nature of detecting those chemicals in body
fluids. It would remove the misdemeanor offense charge and place it with the
same category of possession of narcotic substances, which is important for those
who minimize the serious complications that occur and I make reference to the
internet recipe. Lastly, it would make a means available to those person who
suspect that they may have fallen victim to date rape drugs and allow for more
sensitive and selective drug detection methods.
Page 35 PREV PAGE TOP OF DOC
I
want to emphasize that Date Rape Drugs cover a broad category and I have focused
on only one of these drugs in the interest of time. Other drugs to be considered
include alcohol, chloral hydrate (Mickey Finn), other Benzodiazepines, Ketamine,
Marijuana, D-Lysergic Acid (LSD), and phencyclidine. Along with GHB these drugs
may produce an altered state of consciousness and memory loss, making the victim
of a sexual assault that ensues an unwilling or unknowing
participant.
I will conclude my remarks at this
time, thank you for your time and interest in this
topic.
Mr. MCCOLLUM. Thank you very
much, Dr. Carter, for that enlightening
testimony.
Mr. Stevens, you are
recognized.
STATEMENT OF MICHAEL STEVENS, DETECTIVE, UNDERCOVER DRUG
INVESTIGATIONS, ORLANDO POLICE DEPARTMENT, ORLANDO,
FL
Mr. STEVENS. Good afternoon. I
would like to thank the chairman and the committee for having me here today. I
would like to start my remarks by stating simply that I am not an administrator,
I am a street detective. Therefore, some of my remarks will be very
straightforward.
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Two
days ago I was buying GHB in a club in Orlando. Three days ago I was buying 100
Rohypnol pills. And, a week ago I was buying two bags of
ketamine.
In 1995, the Orlando Police Department
started having trouble with what we call the Rave subculture. Officers were
finding drugs they had no experience with: MDMA, methylene,
dioxymethamphetamine. Pills were popping up—that none of the officers who had
been trained to fight crack cocaine, powder cocaine and marijuana had any idea
what it was.
In early 1996 we started
establishing a unit that worked primarily the new Club/Rave scene that was
coming up. We started getting officers trained for undercover work in it and
started putting people inside these clubs and inside these Raves. We began
finding a smorgasbord of drugs, everything from prescription drugs to drugs that
we didn't even have a way of identifying. We ended up calling pharmacies at our
hospitals, trying to ask them what kind of drug is this, what pill is this. The
drugs ran the gamut, everything from depressants to stimulants to hallucinogens.
You name it, they had it.
Through 1997 we
continued to target dealers. The trend became worse. What started out as small
amounts of drugs were becoming bigger and bigger. Two drugs in particular began
to get a very nefarious reputation with them. One was flunitrazepam, under the
trade name Rohypnol. In 1996 we were buying Rohypnol any time we wanted it; 30,
40, 50 pills at a time. These were the 2 milligram pills. Fairly cheap, easy to
get, most of it being sold by females.
Again,
this is the central Florida area, is what I am speaking for, and that is all I
can.
Page 37 PREV PAGE TOP OF DOC
Rohypnol
at that time was very popular as what is called a landing gear, something that
brought people down from their MDMA high. It is actually a stimulant. They were
using Rohypnol to bring them down so they could go home at night without their
hearts racing a mile a minute.
Unfortunately,
when they were taking Rohypnol, they didn't know the dosages they could take.
They didn't know how much they could take, and we were having a lot of
overdoses, a lot of people just passing out, a lot of people going into
respiratory arrest. All the overdoses in my department go pass my desk, and we
were seeing an average of 15 to 20 in downtown Orlando a night out of
nowhere.
Most of the Rohypnol we were seeing was
coming from Mexico up through Miami and South Beach
area.
Sometime during early 1997 the State of
Florida passed a trafficking law for Rohypnol, flunitrazepam, making it 4.0
grams and over would be trafficking. Within about 3 months the dealers in
flunitrazepam knew about that, knew the trafficking, knew the minimum
mandatories through the Internet. The information was passed on from dealer to
dealer to dealer through the Internet and E-mails. Rohypnol sales dropped
markedly. It cost us a lot of money to buy ''ruffies'' at that point in time,
which is the street name for them.
But a new
drug, just when we thought we had that drug worked out, a new drug popped up and
that was GHB. GHB right now in Orlando is battling Ecstasy, or MDMA, for the
number one Rave/Club drug, without a doubt. Two days ago I was watching kids as
young as 17 shrugging down capfuls of GHB in a club and out in the parking lot,
money changing hands left and right.
Page 38 PREV PAGE TOP OF DOC
GHB
right now is taking over the date rape drug moniker that ruffies did. A lot of
these people here have more degrees than I do to tell you about the pharmacology
and they will explain why it is, but I can tell you honestly from a drug cop's
point of view it is out there and it is everywhere, and we are talking kids as
young as 14 and above.
There is no control. There
is a complete lack of knowledge on the kids' part. Most of these kids are 18,
19, 20. They cannot afford to drink, so they take GHB because they think it
mimics the effects of alcohol without the hangover. They have no understanding
of what it does or what it is. All they know is their friend took it and they
lived, so I will take it and it is okay.
One of
the things we started seeing with Rohypnol was the organized groups that were
conducting sexual assaults with it. That has been documented by informants that
work for me. Groups would go in with what is called the distractor, a guy who
would meet a woman inside a club, keep her busy while another drugged her
drink.
GHB has become the same way, and it is a
lot easier to do with GHB. GHB can be carried in a Visine bottle, whereas
ruffies had to be carried at least as pills. If a cop searched you at the door
and he found pills, he knew what he had. We don't know what we have. We have a
kid with a Visine bottle. We don't know if it's GHB or not. It can't be field
tested. It has to be sent to a lab. It is very easy to be put in a drink. It is
clear. It is odorless. It takes no time for it to dissolve in a drink. The only
thing you might get is a salty tasting liquid. If you mix that with a Coke or
something, you will not notice it.
Page 39 PREV PAGE TOP OF DOC
The
other thing we are getting with GHB is they are making it in people's bathrooms.
They are getting it off the Internet. They are paying $80 for a kit. Comes in
the mail from whatever State allows it. It comes across the mail, boom, it is in
the guy's house and he is making pounds of GHB, and we cannot control it. We
can't find it. All we know is it is getting into the clubs, usually in a liquid
form in Orlando. It is probably now the most popular drug in Orlando right now
on the club scene.
As I said before, I can't tell
you what is happening in the other States, but I guarantee you it is going to be
darn similar to Orlando. In 1997 we had the dubious distinction of being voted
by Rolling Stone as the number one techno music city, so we have a pretty good
edge on the Rave culture and what goes on. These drugs are out there, your kids
are in them, they are using them, and I think it would benefit law enforcement,
and this whole country if the Federal Government would put some backing behind
it, give us something to work with to where we can do something with these
drugs, and I thank the committee.
[The prepared
statement of Mr. Stevens follows:]
PREPARED STATEMENT OF MICHAEL STEVENS,
DETECTIVE, UNDERCOVER DRUG INVESTIGATIONS, ORLANDO POLICE DEPARTMENT, ORLANDO,
FL
62309a.eps
62309b.eps
62309c.eps
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62309d.eps
62309e.eps
62309f.eps
62309g.eps
62309h.eps
62309i.eps
62309j.eps
62309k.eps
Mr.
MCCOLLUM. Thank you very much, Detective
Stevens.
Professor Doering.
STATEMENT OF
PAUL DOERING, PROFESSOR, DEPARTMENT OF PHARMACY PRACTICE, UNIVERSITY OF
FLORIDA
Mr. DOERING. Good afternoon,
Mr. Chairman and members of this committee. It is a privilege and honor to
address this group on the subject of GHB, the dreadful drug of abuse that is
wreaking havoc in communities all over our country. I come here today to express
the concerns that I share with my colleague, Dr. Michael Okun, a neurologist at
Shands Hospital at the University of Florida.
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Exactly
what is GHB? Well, as you have heard, GHB is shorthand for a chemical called
gamma hydroxybutyrate, known on the street by a variety of slang names,
including Liquid Ecstacy, Nature's Quaalude, Zonked, and the particularly
offensive name Easy Lay.
GHB is a simple molecule
related to one of the chemical messengers in the brain. GHB depresses the
central nervous system, and when combined with alcohol or other tranquilizing or
sedating drugs there is a resulting chemical overload in the brain that may lead
to cessation of breathing. In addition, heart rate can slow, blood pressure can
drop, coma can set in and deaths have
occurred.
The problem of GHB is nationwide, from
St. Petersburg to Sacramento, Dallas to Detroit, from Orlando to Omaha, reports
of deaths, near deaths, sexual assaults and other problems pouring in. New
reports of toxicity are appearing with increased frequency in the medical
literature as well.
In June 1998 an article
appeared in the Annals of Emergency Medicine reporting a series of 88 patients
seen in a San Francisco emergency room. We have seen 10 cases in our hospital
alone, and this does not account for the numerous problems that never come to
the attention of medical personnel. We have had to place five patients on
breathing machines, one of whom developed a complication and remained
hospitalized for 9 days. Luckily, we have had no GHB-related deaths at our
hospital, but without some swift action it is just a matter of time until we
do.
Prior to 1990 GHB was available as an
over-the-counter pill or powder sold mostly in health food stores, but the FDA
pulled it from the shelves because of deaths and serious illnesses related to
its use. Today the major source of GHB sold on the streets is homemade from
cheap kits obtained over the Internet. It is mixed largely by nonchemists from
recipes that are often flawed or incomplete, and this leads to finished products
of questionable purity and, more importantly, unknown potency. Because there is
no way to tell the strength of homemade GHB, what might be a safe dose today,
for example, one capful, could produce a toxic dose tomorrow.
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The
misinformation surrounding GHB is most troubling. Proponents of GHB often appeal
to the anti-government, anti-establishment mentality of potential users. One
seller calls GHB, ''Not only very safe, but also extremely beneficial,'' and
brazenly offers, ''a $10,000 reward for any scientifically documented permanent
harm'' from the drug. He finishes his message by stating, ''It appears that the
only true danger associated with GHB use is the loss of billions of dollars of
revenue to the alcohol, tobacco, legal and illegal drug pushers and the AMA
malpractitioners of the world when GHB gains widespread acceptance and
use.''
Our impression, after interviewing many of
GHB's victims, is that they are truly Internet educated and honestly believe
this drug is a safe over-the-counter vitamin. Dr. Okun and I decided to fight
back with an information campaign of our own, using the same tools to spread the
truth as others used to spread lies. We set up a web site with the title
''University of Florida declares WAR on MISINFORMATION on
GHB.''
GHB has been and is being studied for a
number of legitimate medical uses, including its use as an anesthetic, for the
treatment of narcolepsy and the treatment of drug addiction. One must remember
this research is done using precise doses of carefully manufactured products
under close medical supervision. Ultimately this drug may prove to have some
therapeutic usefulness, but it should not be available for use as a party
drug.
GHB has gained a reputation as a date rape
drug. To me, nothing is more despicable than using a chemical to disable a
person so that she can be raped. We often visualize the perpetrator slipping the
drug into the victim's drink. Let us not forget the person who willingly takes
the drug for purposes of partying, only to have the drug incapacitate them. This
makes them an unsuspecting target for the rapist who might seize the opportunity
to take advantage of the drugged partier when she is unable to resist.
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Unscrupulous
sellers of the dangerous chemicals used to make illegal drugs are very creative,
and will use whatever loophole they can find to peddle their deadly wares. One
site claims they sell their kits only for purposes of demonstrating a type of
heat-producing chemical reaction called an exothermic reaction. Here is part of
their disclaimer:
''This experiment is for lawful
use in research and study only. Purchase of this kit does not give permission to
the buyer to perform this experiment. It is meant to provide an educational
experience in an exothermic reaction as well as showing properties of molecules
when reacted.''
With the new school year rapidly
approaching, we hope to intensify our war on misinformation. Needless to say, we
have received some interesting electronic mail messages in response to our web
site. Some are open and honest exchanges of perspective, while others are
attacking. Some will break your heart. I would like to close by reading you an
excerpt from one message received by Dr. Okun from a grieving sister of a young
whom who died from GHB.
''I just want everyone to
read and understand how dangerous GHB is. My sister who was only 22 died. My
sister is gone now, and we can never see her beautiful smile nor hear her
wonderful laugh, but through the words of people like yourself, maybe 1 day
people will stop, listen and learn.''
Thank you
for your kind attention to these comments.
Mr.
MCCOLLUM. Thank you very much, Professor Doering.
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We
will now proceed to a period of questioning by the Members of Congress who are
here today under the 5 minute rule, and I will recognize myself for 5
minutes.
Detective Stevens, in your experience
out on the street, is GHB known just as that; do kids call it that? Is that what
they call it, ''GHB''?
Mr. STEVENS. We
have heard it called ''G'', Liquid X, Grievous Bodily Harm, and what they are
calling it now is ''water'' because that seems to be the common way they are
carrying it. They are carrying it in some kind of water bottle, Evian, Zephyr
Hills.
To understand GHB and how it fits into the
club scene, you have to understand exactly what the Raves are. The primary drug
in the Rave is MDMA, the stimulant. When they rave and they dance, they get hot
and dehydrated; they drink a lot of water to rehydrate themselves. They also
drink the water with the GHB in it to bring them back down from their
stimulant.
Mr. MCCOLLUM. The stimulant
is to get them to be able to dance a lot?
Mr.
STEVENS. From like 9 o'clock at night to 7 in the morning. I tried it
sober. It is not a pleasant experience. You just can't do it. That is why they
take the Ecstasy, to give them the continual energy. But at 7 in the morning or
so, when they need to come down, Ecstacy doesn't just shut off, and that is why
they use this ''landing gear'' to bring them down from their flight so that they
can go ahead and come back to normal, usually ''ruffies'', flunitrazepam, or GHB
or some other prescription drug like Valium.
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But
that is what they are doing. They are combining it with water and drinking it.
Unfortunately, they don't know the purity levels or how
much.
Mr. MCCOLLUM. Is that combined
with the water before they get there? Is it like a Zephyr Hills water bottle
they have already mixed up, or is it something they mix there at the
club?
Mr. STEVENS. The dealer, I
watched doing it, had a large—probably a liter water bottle that he had already
premixed. He was serving capfuls. One capful cost probably $25. And they were
either dropping it into the water when they approached him or they were taking
it right there at the car.
That is what makes it
difficult for us to buy GHB at that level, at a street level. They want you to
take the GHB right there at the car. Obviously we are not going to use the drug,
so we are left with either to arrest the person right there and destroy whatever
undercover operation we are using, or to go ahead and simply watch him and try
to follow him. Most of them, like with LSD, they make you take it right there at
the scene.
Mr. MCCOLLUM. And it is out
on the street literally, not in the club itself but on the street usually, where
this is happening: Somebody walks out the door and goes to the parking
lot.
Mr. STEVENS. Right. Most of the
clubs in Orlando have very vigilant security, especially with all the pressure
that has been applied to them. A lot of the stuff that we are seeing now is
occurring in parking lots where there are not enough police officers, and
security to cover it. They are in and out of the club all night long. If they
get customers, they take them out to the car, serve them, and go back to the
club.
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Mr.
MCCOLLUM. Mr. Farias, is this the type of setting you think your
niece was involved with the night she encountered
GHB?
Mr. FARIAS. Well, yes, sir. It is
a club. And I believe, supposedly someone slipped it into her drink at the club.
But at that time no one was aware of GHB except for the
youth.
Mr. MCCOLLUM. Was it a dancing
type of club like the Rave scene Mr. Stevens is talking
about?
Mr. FARIAS. No, it is a regular
night spot. A country western.
Mr.
MCCOLLUM. So the way she got it may be a little different than the
way he is describing a lot of it being used in the Rave
scene?
Mr. FARIAS. That is
correct.
Mr. MCCOLLUM. Professor
Doering, what was the purpose and what was the use of GHB back before it was
banned? What was it being used for?
Mr.
DOERING. Well it was sold in health food stores as a powder or as a
pill and principally used by body builders to improve their muscle gain. It
seems that while the patient is under the effects of GHB their levels of growth
hormone increase, and if that is combined with a vigorous workout program it can
result in increased muscle mass and weight gain and so forth.
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Mr.
MCCOLLUM. Is there any downside to that, like you see with some other
drugs used among ball players and so forth?
Mr.
DOERING. Certainly it has it own downside risk. People were passing
out, they were combining it with alcohol, they were nearly dying from the drug,
and the FDA decided, whoa, wait a minute, this isn't something we want to have
sold over the counter. I think that is half the reason why the myth about it
being an over-the-counter vitamin has sort of stayed with it, because it was
once used in that regard.
Mr.
MCCOLLUM. Today you have told us there is research ongoing about
possibly constructive uses of GHB. If we reschedule this drug as Schedule I,
would that in any way affect the research that is going on or the possible use
of it for these more constructive purposes?
Mr.
DOERING. In my opinion, it would not. If it did become a recognized
drug under the guidelines of the Food and Drug Administration, then it would be
scheduled differently. But unless and until it is recognized as a medicinal drug
in this country, Schedule I, in my opinion, is the appropriate place for it to
be.
Mr. MCCOLLUM. Dr. Carter, you have
expressed concern over how difficult it is to detect this drug in autopsies and
so forth, and the way Mr. Stevens is describing it, Detective Stevens, it is
very hard to even catch up with who is doing
it.
What is the specific test, can you tell us?
Is it a chemical test? How do you find it? And in the case of Mr. Farias' niece,
how much time had passed? You said a lot of this goes away and you cannot figure
it out, and yet I think you said you found it around the eye or some specific
locations. How did that happen?
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Ms.
CARTER. It can be difficult to detect. It is not on the usual
schedule with cocaine, morphine, phencyclidine. It can be detected by chemical
means and advanced technology. We call it a mass spectrometer, which is an
advanced way of screening fluids. Usually GHB will disappear from the body, from
the urine, within 12 hours.
Because the Farias
family had made the donation, a gift of life, we had that first specimen of
blood and urine retained, and we were able to test that. But we went through
numerous drug screens, and it took us 2 months to finally decide that this was a
drug that was involved in this young girl's
death.
Mr. MCCOLLUM. Wow. Well, thank
you very much, all of you. I will recognize Ms. Jackson Lee for 5 minutes of
questioning.
Ms. JACKSON LEE. Thank
you very much, Mr. Chairman. And let me thank my colleagues as well for their
comments.
Congressman Hutchinson from Arkansas
mentioned the problem of amnesia, which is a real problem. Even if Hillory had
lived, there might have been some impact, I would imagine, on her memory; is
that correct, Dr. Carter?
Ms. CARTER.
That is correct.
Ms. JACKSON LEE. And
as well, my colleague from Georgia mentioned the issue of education, and I would
like to note that the legislation does have a provision to help educate young
people and everyone about the detriments of GHB, I think that is extremely
important, and other forms of drugs.
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Let
me just briefly thank Dr. Carter for her persistence, Mr. Chairman. It was the
persistence of her County Medical Examiner's Office, that felt the passion of
Hillory's family that kept pressing the issue that our teenager, our Hillory,
was not someone who willingly or did take drugs. And it came to my attention
because the normal response when teenager dies suddenly, the images in the press
were a drug overdose. But this family was extremely persistent, and for that I
do thank them.
Mr. Stevens, I would like to ask
you a question. You captured my thought processes with the definition of this
drug as battling, or as being number one, as one of the more popular
drugs.
Mr. STEVENS. Yes,
ma'am.
Ms. JACKSON LEE. Your
representation, and I thank you very much, was that it may be only in Florida,
but just listen to this out of Los Angeles:
''The
widely publicized June 26, 1996, incident in the 400 block of Fairfax Avenue in
Los Angeles, when four males between the ages of 16 and 20 were found
unconscious on a public street after consuming GHB, is powerful testimony to the
need for control of this substance.''
Mr.
Chairman, this is from an article on GHB, ''Old Drug-New Tricks'', from
Detective Trinka Porrata, Los Angeles Police Department, dated May 11, 1998, and
I would ask permission of the chairman to submit this into the record.
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Mr.
MCCOLLUM. Without objection, so
ordered.
[The information referred to
follows:]
GAMMA HYDROXY BUTYRATE
OLD DRUG—NEW TRICKS
BY
TRINKA PORRATA
Gamma hydroxy butyrate (GHB, also
called G, Liquid X, Liquid Ecstasy, Grievous Bodily Harm, Georgia Home Boy,
Scoop, Great Hormones at Bedtime, Salty Water, Water, Everclear, Aminos, GH
Buddy, Blue Monster) has become a growing problem for law enforcement. On
September 28, 1997, GHB became a Schedule II drug in California (the original
legislative proposal, initiated by the LAPD, requested Schedule I placement). At
least 20 other states have scheduled GHB, three more states have criminalized it
with stiff penalties, and federal legislation to control GHB (Schedule I) is now
pending in both the House and the Senate.
More
than fifty-eight deaths (plus about 30–40 more pending), including twelve in
California (plus seven or more California cases pending review), are listed as
GHB-related deaths and more are being researched by the Drug Enforcement
Administration. Many more deaths have undoubtedly gone without notice since GHB
is not part of a standard toxicology screen. Many of those deaths are
individuals under the age of 30. Far too many of the deaths, especially those
within the past few months, have involved individuals between 15 and 20 (See
attached document re GHB related deaths). More than 5,500 overdoses have been
documented (with more occurring during the last few months). In Toms River, New
Jersey, more than 24 people were treated for GHB overdoses Memorial Day weekend.
An additional 13 overdoses were reported Fourth of July weekend in Toms River,
plus one death on June 1, 1999. Nationwide, multiple overdoses are swamping the
emergency rooms. Recent incidents include five teens overdoses in a Michigan
community and three 13-year-olds frothing blood through their noses (evidence of
pulmonary edema) at a party in Louisiana.
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The
widely publicized June 26, 1996, incident in the 400 block of Fairfax Avenue in
Los Angeles, when four males between the ages of 16 and 20 were found
unconscious on a public street after consuming GHB, is powerful testimony to the
need for control of this substance. The young men, who reside in Woodland Hills,
Westlake Village, Berkeley and Agoura, were in various stages of respiratory
arrest and at least two had to be resuscitated. In truth, far more than four
were seriously impacted by this drug that night. One of the first officers to
arrive described it as one of the most eerie scenes he had ever witnessed. With
ghostly fog as a backdrop, they were confronted by dozens of people in various
stages of overdose and/or under the influence, running (but in slow motion) or
staggering or lying around. They asked for paramedics, and more paramedics and
finally requested, ''Clear the station, we need some people out here.'' Most of
them, however, had disappeared before assistance
arrived.
The 16-year-old later stated that he had
consumed 12 beers, several Dexatrim (diet pills) and then took two ''swigs'' of
GHB, which was offered to the large group in a gallon water jug, and literally
dropped dead. Paramedics brought him back. He stated that the substance tasted
like ''cow manure'' and that he recalls nothing from that moment until he awoke
in a hospital bed, grateful to be alive. He said that his friends advised him
that after drinking GHB he was grinning ear to ear with his eyes rolling in
opposite directions, and he became ''flirtatious'' with the females in the
crowd. And then he collapsed and literally died until medical assistance saved
him. He has been in drug rehabilitation and doing
well.
A 19-year-old participant, the only one of
the foursome who did not lapse into a coma, stated he had used GHB before. He
noted that, depending on how much is consumed and what other drugs are consumed,
you feel good for a period of time, up to about two hours, and then you sleep.
He added, ''It's easy to get. There's no punishment if you get caught, so it's
cool.'' It was never really cool, and now it is illegal.
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Incidents
of GHB overdose occurred repeatedly throughout 1996, including multiple
incidents in the Hollywood area, plus Orange County (at the Rhino Room), and in
Australia (ten collapsed, five on life support). It is important to understand
that in each of these incidents, one third to one half of those who collapsed
actually ''died'' and were revived by drastic measures by paramedics and/or
sustained on life support until the danger passed. These are witnessed
overdoses. If they had occurred inside a van in the parking lot, for example, or
at home alone, there would have been no one to summon paramedics and reverse
their date with death.
A behavioral depressant
and a hypnotic, GHB is being used in conjunction with alcohol or other drugs,
with detrimental effects in an increasing number of cases. It is difficult to
isolate the impact of GHB ingestion since it is so typically taken with an
ever-changing array of other drugs and especially alcohol, which potentiates its
impact. Furthermore, no one tests for this drug unless the patient history
indicates GHB or the circumstances dictate a search beyond routine drug testing.
GHB is an anesthetic (sleep inducer) without analgesic (pain relieving)
properties that has been found naturally occurring in minute quantities in brain
and other tissues in the human body.
NOTE: The
fact that GHB occurs naturally in the human body does NOT make it safe; it
appears naturally in tiny quantities. Ask any rattlesnake if it would like to
have its own venom injected into its body! After all, poison ivy is ''naturally
occurring.''
GHB has no nutritional value. Side
effects from ingested doses include high levels of intoxication, nausea, coma
(sometimes abrupt and profound), uncontrollable seizures and respiratory
depression.
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While
the objective symptoms reflect a CNS depressant (from a law enforcement
perspective), according to Dr. Wallace Winters, who researched GHB 30 years ago
and in 1997 retired as a Medical Officer with the Food and Drug Administration,
the brain wave pattern of GHB users reflects various stages of epileptic seizure
(dose related). This is at least true of research cats, though some aren't so
sure that it transfers over to humans. If so, it may in reality be a CNS
excitant, but external symptoms shut down and appear depressed, especially with
higher dosages. In fact, 30 years ago, Dr. Winters predicted that this would
become a horrible drug of abuse; his only surprise is that it took so long to
happen.
Frankly, law enforcement was first seeing
only the attention-drawing, collapse-level overdose cases and did not initially
get much experience with less than overdose levels until more recently. During
my early research on GHB, I found some documents saying yes, GHB produces
nystagmus and others which said no, it doesn't produce nystagmus. Based on
recent research by Dr. Alex Stalcup of the New Leaf Treatment Center in the Bay
Area, it appears that nystagmus may not be seen in very low dose usage, but will
likely appear at higher doses and overdose
levels.
Because GHB takes the same path as
alcohol, processed via alcohol dehydrogenase, its symptoms at lower levels of
intake and as impact builds are comparable to alcohol ingestion/intoxication.
The ''happy'' alcohol drunk will more likely be a ''happy'' GHB drunk; the
''mean'' alcohol drunk will likely be a ''mean'' GHB drunk. Thus, aggression and
violence can be expected in some individuals. Because GHB reduces inhibitions
and seems to stimulate sex-oriented behavior, you may encounter someone on GHB
running through a crowd grabbing the breasts of females as they pass, for
example (as the 16-year-old described).
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During
June of 1997, one male at a Hollywood Club ran around grabbing females in the
crotch area and was booked for battery on a security guard who tried to
intervene. People in the crowd later stated he had been seen taking GHB. His
belligerent and sexual behavior both are indicative of GHB. Since he neither
vomited nor went comatose, it can be assumed that the dose taken was relatively
moderate. Two hours later a second individual became aggressive in the Club,
fighting police officers, who were at the scene for another incident, and being
pepper-sprayed by them. His girlfriend stated he had taken GHB 30 minutes prior
and advised me where he had the container in his pocket. His prescription pill
bottle (no pills—contained a small quantity of liquid) was booked and tested.
The contents were positive for GHB and no other drugs were present (GHB is on
occasion laced with MDMA, crystal meth, or other
uppers).
Users claim it to be an aphrodisiac.
Many say, ''It makes you want to have sex.'' It clearly releases inhibitions. It
also makes most people vomit. Undercover film, shot by news crews with hidden
cameras, show users getting wildly giddy and then vomiting as casually as one
might spit tobacco in a spittoon!
While that
aspect seems less than ''sexy'' conduct, it must be understood that the user, at
that time, may not feel ANY sensation of being ill. Users commonly describe a
feeling of security and sleepiness and no recall of being nauseated, though they
may wake up to indications of having vomited repeatedly. One overdose victim
stated, ''I just felt so safe and secure. I just wanted to go to sleep. I
thought I was just nodding off. I couldn't understand why the 50 people around
me were screaming and hysterical. It was like I was outside, watching myself and
them. I could hear them, but couldn't understand their reaction. I couldn't seem
to communicate my feelings of security to them. Finally, I did become a little
anxious, realizing that they must know something I didn't know.'' What he
thought was ''nodding off'' were seizures.
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He
said he realizes now that if he had been alone or with people used to the
experience who did not get excited at his condition, he would not have had any
idea of how dangerously impaired he was. Without that reality check, abusers
wake up with a false sense of security and use again and
again.
GHB users on the Internet are now
stressing use of very low doses of GHB to intensify the spiritual, euphoric,
out-of-body experience that they crave; trying to avoid the dangers of overdose
seems to be of secondary concern. This will likely translate into law
enforcement seeing more and more GHB driving under the influence cases. Both New
Jersey and California (Los Angeles County) have DUI traffic deaths where other
parties were killed by a driver under the influence of GHB. The Los Angeles
Sheriff's Department case recently resolved with the suspect pleading to
vehicular manslaughter (11 years plus three years enhancements and will do 85
percent of that time, plus he waived time served, 14 months). He admitted in
court to alcohol, GHB, driving and killing
someone.
Unfortunately, during Spring Break of
1998, GHB users in Florida discovered the secret we had hoped no one would
learn. We had known for some time that drinking GBL, the primary precursor of
GHB, by itself is the same, or worse, than drinking GHB. Panama City was one of
the cities absolutely rocked by GBL overdoses. Users suffered severe body
tremors and psychotic episodes, according to news accounts. Medical and law
enforcement personnel swear the effects and recovery from GBL is far worse than
GHB. GBL is an analog of GHB and should be treated as such, at least in states
with analog laws, such as California. Florida, unfortunately, did not have their
statute re GHB written to cover analogs, and GHB has several. GBL, a floor
stripper or degreaser, was brought into the area in 55 gallon drums.
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GHB
is available in Europe as an anesthetic; in actuality, it is used primarily only
in France and requires giving the patient other medications to block pain and
stop the nausea which so often occurs. While this drug has been around for many
decades, it is not widely respected and used in any medical community. GHB is
currently legitimately available in the United States SOLELY on a restricted
basis as an ''Orphan Drug'' for experimental treatment of narcolepsy. GHB
encountered in California is illicitly produced and is primarily distributed as
a liquid.
NOTE: Placing GHB in Schedule I, in any
state or federally, would NOT alter its availability to those now using it in
LEGITIMATE research and treatment. On the other hand, placing it in Schedule II,
for example, will technically NOT make it legitimately available to anyone not
already authorized by the FDA.
GHB is a
behavioral CNS depressant that was originally abused by bodybuilders who
believed it stimulated the body's production of growth hormone. It is still
being heavily used by body builders and their associates, though it appears its
use by them now is as much for deliberate abuse as it is for any dreamed-of body
gains. It has now become the drug of choice on the Los Angeles party scene,
primarily in Hollywood area, the West San Fernando Valley, and in the
Newport/Laguna Beach area. It is widely used from San Francisco to Santa Ana and
San Diego. It is common in some gay communities. GHB was allegedly involved in
the drug abuse cycles of both Billy Idol (who overdosed in a Hollywood Club) and
River Phoenix (who died), both reportedly experiencing
seizures.
More than fifty eight deaths, including
about twelve in California, (plus 30–40 more pending review) are now listed as
GHB related deaths. On August 4, 1996, a role-model teenager in La Porte, Texas,
died mysteriously after GHB was slipped into her soft drink. On September 11,
1996, that death was ruled to have been a homicide, caused by GHB. This was an
unwitnessed overdose—she went home and went to sleep and died. Many more deaths
have undoubtedly gone without notice since GHB is not part of a standard
toxicology screen. When the first of three bills to criminalize GHB hit the
California Legislature on February 25, 1997, a father came forward on behalf of
the bill because his son had died from GHB ingestion; he held the coroner's
autopsy report stating GHB as the cause in his hand. This was yet another death
previously uncounted and another unwitnessed overdose—he was drunk, took GHB and
passed out and was left to sleep it off, but died during the night.
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Fortunately,
drug analogs (drugs which are primary precursors or are designed for use in lieu
of the drug) are covered in both Schedule I and II. GHB has several analogs of
grave concern, including 1,4 Butanediol which surfaced in Los Angeles on New
Year's Eve (December 31, 1996) in a vial called FX and labeled as kava kava.
Within an hour, 30–50 individuals collapsed from ingesting the substance,
including a 17-year-old who had a heart attack but survived. There was no kava
in the product, just an incredible blast of caffeine and the 1,4 Butanediol,
which is converted into GHB by the body adding an oxygen molecule. This analog
of GHB has now surfaced in Northern California as a Russian herbal product, in
the state of Washington and possibly in Canada. The manufacturer of FX has now
plead guilty in federal court to charges of mislabeling and misrepresenting a
product.
The Los Angeles County Sheriff's
Department recently successfully prosecuted a Lawndale party disc jockey and two
accomplices for drugging and raping ten women and poisoning six others (knocking
out their dates, in some cases). The primary suspect was found guilty on 44
counts; the second suspect was guilty on seven of 15 counts; and the third
worked a deal. The primary suspect was then sentenced to 77 years. Photographs
depicting sex between the men and unconscious women were found in the disc
jockey's van. The victims in this case were enticed into drinking unusual mixed
drinks (such as the ''Oatmeal Cookie'' drink) as a method of covering up the
unpleasant, salty taste associated with GHB. Some victims noted nothing unusual
about the taste of the drinks; some reported it tasted bad or salty; and one
stated that it burned (probably indicating a very high PH level in that batch).
GHB was identified in margarita salt. It should be noted that there were no
positive toxicology tests in this case partly because sexual assault kits at
that time did not include urine (they do now for all of Los Angeles County) and
partly because of the time factor (victims reporting beyond the possible time
limit of 12 hours for getting a GHB positive)
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''Goldschlager,''
a cinnamon flavored liquor, (or comparable product) has come up in GHB
investigations several times, used to mask the salty taste. Long island ice teas
or margaritas are also sometimes used.
Unlike the
use of Rohypnol, where the victims are more likely to be totally unsuspecting
and unable to taste the drug slipped into their drink, victims of GHB sexual
assaults or overdoses are typically convinced to try GHB as an ''energy drink''
or are talked into trying an unusual concoction. The salty taste is still
noticeable, but the victim may simply not sense the
danger.
NOTE: This problem was much LIKE the
Rohypnol (flunitrazepam) issue in that it was NOT under the California
Controlled Substances Act (Rohypnol became controlled as of January 1, 1997),
and it is in fact also used in a number of rapes since it does induce sleep. Law
enforcement has, until now, been unable to deal effectively with issues of
possession, transportation or sales of GHB.
It is
UNLIKE the Rohypnol issue in that Rohypnol is almost exclusively manufactured in
quality controlled labs, albeit outside the United States, and is smuggled into
this country, while GHB is primarily manufactured in ''bath tubs'' with little
regard for proportions and cleanliness. This results in increased danger from
contamination and excessive PH level (''drain cleaner'') and more unpredictable
reactions. GHB powder from Switzerland and liquid in bottles marked ''For
research only'' and presumed to have come into the U.S. via Mexico (as per
statements by suspects) have been encountered.
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While
Rohypnol is known for its paralyzing effect and anterograde amnesia, obvious
benefits to an attacker, GHB (which also causes amnesia) is perhaps best known
for its intense intoxication and enhancement of sexual interest. Thus, GHB
provides a different set of advantages to an attacker and a different level of
nightmare for both the victim of sexual assault and for the law enforcement
agency seeking to prosecute.
Sexual assault
investigators are reporting an increasing number of cases involving the use of
drugs such as GHB, Rohypnol, Flunitrazepam, Ketamine (behavioral analog of PCP
and an animal tranquilizer), Halcion (controversial sleeping pill from which
Rohypnol was derived), Xanax (another benzodiazepine), or Ambien,
etc.
NOTE: Ketamine (Special K), MDMA (Ecstasy)
and GHB are not ''street drugs'' at this time, but flow most freely in the RAVE
crowd. They are the drugs of preference because they are what I call ''soft
hallucinogens.'' Granted, that's my own descriptive term. The real stuff (LSD,
PCP) take one beyond reality, hearing colors, feeling sounds. These three drugs
are credited by their proponents with intensifying reality, letting one see
one's inner self, giving a spiritual, out of body experience,
etc.
All officers should be aware of all above
mentioned drugs and their potential use in sexual assaults or other crimes such
as robberies. These drugs also present officer safety issues, especially for
those working in undercover assignments. Most of these drugs must be identified
through urinalysis by current technology and within a relatively short time
span, while blood has been the common item associated with evidence testing for
sexual assault cases in the past. GHB presents special problems re testing. This
has created a need for law enforcement to re-think and re-write protocols for
handling sexual assault cases, at least where drug use is a possible factor.
Newly formulated sexual assault evidence collection kits (now countywide in Los
Angeles) include urine samples. Officers should be alert at the crime scene for
any loose pills, vials, empty blister pack fragments, drink glasses, milk jugs
or sports-type bottles, for example, that might harbor important evidence of
drug use.
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We
have recently been getting an increasing number of sexual assaults in which
multiple drugs are found in the victim's urine, or stimulants are found, but
perhaps no ''rape drugs.'' When pretext phone calls are utilized, the suspect
may comment about her use of various drugs. Listen closely, he may be telling
you what drugs he employed, and is just trying to put them off on her as
voluntary. First and foremost, get to know your victim; the credibility of your
victim is important. If you believe her, dig deep. Do not write it off just
because stimulants are present. Consider now the timing and testing issues. Was
the urine sample taken AFTER GHB and/or other drugs would have been eliminated?
Did the symptoms she experienced and described match with a drug that could have
already been eliminated?
Here is where the expert
witness testimony becomes critical. She may have been enticed to ingest the
other drugs while highly intoxicated by alcohol and GHB, for example; OR she may
have involuntarily ingested the additional drugs. The suspect may have blown
meth or cocaine or ketamine (Special K—stimulant but with paralyzing effects for
at least a brief period) or MDMA (Ecstasy) literally up her nose (or in some
other manner). Remember, you have to REQUEST testing for unusual drugs. And, can
you trust your testing source? Do NOT base your handling of the case based on a
preliminary screen for drugs. The benezodiazepine screen does NOT pick up on
Rohypnol and many other benzos (such as lorazepam). NOTE: There are about 15–20
benzo's approved for use in the U.S. and numerous other foreign benzo's such as
Rohypnol.
Every possible piece of evidence from
witnesses is important as to her normal condition, normal drink tolerance,
normal or abnormal behavior prior to or at the time of the incident, etc. Do a
thorough interview as to timing involved (between drinks and incident, etc.),
what she does and doesn't recall, and feelings she experienced. Does she
articulate an out of body phase when she watched it happen to herself as if on
TV, but couldn't control the action? This symptom could be induced by a variety
of drugs. Don't ''lead'' your victim with questions like, ''And then did you
feel this way...........?''. Let the drugs talk to you and then see what drug(s)
fits the pattern that develops.
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There
have also been a couple of recent rapes involving ''booting.'' This is a sexual
practice, heterosexual or homosexual, involving putting cocaine or
methamphetamine on the penis or in the vagina or rectum. Both parties get some
drug effect from this practice, though not the ''rush'' associated with other
forms of drug use. I've heard of some apparently unrelated cases which have also
involved the practice of shaving the victim's pubic
area.
Several crime labs in the State may be able
to determine if a substance is GHB, but may not be prepared to perform analysis
on bodily fluids for the presence of GHB. Blood is the primary sample for
analysis, ONLY if there is reason to believe the victim ingested the GHB within
the past four hours, as it remains in the blood for only four to five hours. If
the victim dies, it will remain in the blood. Fortunately, the Los Angeles
County Coroner's Office is now among those capable of testing for GHB, joining
the Orange County and San Francisco Coroners and
others.
GHB is rapidly absorbed, with peak plasma
concentrations occurring 20–60 minutes after oral administration. At a dose of
12.5 mg/kg, half life is 20 minutes. GHB is almost completely oxidized to carbon
dioxide. Only around five percent is eliminated in urine. Quality of testing and
availability of testing for GHB in both body fluids (blood and urine) are
progressing rapidly in response to this health danger being recognized
throughout the country. Work on a field test for law enforcement is
underway.
Since 1990 it has been a federal
felony, under the Food and Drug Administration (FDA) rules, to manufacture GHB
and transport it across state lines for purposes of sales. You may wish to
contact the FDA in some manufacturing cases where you have indications of
crossing state lines with the precursors or the final product. The FDA will
prosecute manufacturing and transportation cases involving appropriate
quantities and circumstances. At this point, no GBL (the primary precursor) is
made in California, indicating that interstate commerce has indeed already
occurred. Even prior to GHB becoming controlled here, California laws relating
to food and cosmetics (consumer fraud type sections) could be employed to deal
with suspects selling GHB, providing the local prosecutor was willing to deal
with the unusual case.
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It
is important to stress that though it has been placed in Schedule II, normally
reserved for triplicate prescription drugs, GHB is NOT available for
prescription is California since it is a federally banned
drug.
GHB is being manufactured throughout the
State. It is easily made and involves just two basic ingredients, available at
any chemical supply house: Gamma butyl lactone (a solvent used for degreasing
engines or cement or stripping floors, for example) and sodium hydroxide (lye).
Muriatic acid or vinegar may also be present; these may be used to ''back down''
the PH level after initial processing, just as you control your pool's PH level.
A clear liquid, only slightly thicker than water and with only a mild odor and
usually transported in rather common or subtle containers, GHB is going to be
difficult to verify ''on scene.'' The PH level would be one indicator, but not
definitive. In many cases the PH level will be 11–14, but not necessarily and
not if it is a properly manufactured
version.
Kits to make GHB are sold over the
Internet. A GHB liquid lab is the easiest lab operation you will ever encounter.
Some recipes involve using acetone in the process (if trying to powder it), and
some labs have exploded. The U.S. Attorney General's Office is now pursuing some
cases against Internet dealers.
It has been
reported that some meth operations may run a cook of GHB between meth runs.
Agencies experiencing problems with GHB abuse should establish contact with
local chemical supply houses to determine who is making regular, quantity
purchases of these items.
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The
LAPD Clandestine Lab Squad in late October arrested eight at a crash pad
maintained solely for the purpose of producing GHB. Charges were filed on two.
Most of the people present had ties to Hollywood promoters, recording companies,
etc., including the two members of the RAVE band called ''The Crystal Method.''
The band members have been bragging about their experience, but failed to
mention in their press release or on MTV that they were the two guys found
hiding on the rooftop (in the vicinity of some brew that was cooling). This
proves the point that much of the GHB is coming into the clubs via the back
door. The Hollywood Athletic Club began searching incoming patrons, but the
flood of GHB continued. They now need to look at their bands and promoters. Labs
have also been encountered, since the law took effect, in San Francisco and Mono
County.
The actual number of deaths from GHB will
never be known since no one was testing for it until recently and usually only
when GHB is given in the patient history. Additionally, there is no formal
reporting system in place, leaving it to word of mouth (DEA officials counted
only those they ''heard'' about that they could verify with an autopsy report).
While early in 1997 only six or seven deaths were officially counted by DEA,
that figure is now rapidly climbing as the coroner's reports are starting to
filter in and as more and more agencies come on line to test for this drug. If
Jeffery Fraga (Contra Costa County—California), for example, had gotten into a
car and driven away prior to lapsing into a coma, his death would have been
written off as a DUI fatal accident. A blood alcohol level of .17 (I originally
had been told .12, but .17 is correct in the Fraga case) would justify such an
assumption. But a healthy 25-year-old dying while asleep isn't explained by a
.17 blood alcohol level, resulting in further investigation and the diagnosis of
GHB.
Om 1998 I learned of the death of a
15-year-old in the cold night air of the high desert near Landers during January
1996. This young man attended an all-night RAVE party with 40–50 others. Despite
a variety of drugs available, he chose to go with GHB. While everyone sipped
GHB, he foolishly took a big drink. Frothing blood and obviously in need of
medical help (with the nearest phone many miles away), he was placed near the
campfire. They continued their worshiping of drugs and realized he was dead
hours later. No other drugs were found in his body. GHB was found at the scene
and statements supported GHB ingestion. Hypothermia finished him off.
Unfortunately, tests for GHB in the blood weren't as readily available then, and
its presence was not ascertained. Arrangements were made for the LA Coroner to
test his remaining blood samples. The results were positive, a high level of
GHB. That case is now being handled as a murder case with a federal conviction
(for manufacturing and for supplying a misbranded drug) obtained against the man
who supplied GHB to that party. State charges against him relating to the murder
are pending. Sadly, the victim had struggled with a drug problem and was doing
better. His mother had gotten a job in Arizona and they were moving. This was to
be his last night in California. Instead, it was his last night on this
earth.
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His
situation mimics that of a young woman in Georgia, featured on a CNN
documentary. While everyone else sipped GHB, she boldly took a big gulp and
immediately frothed blood. The supplier commented that she might as well lay
down and die, that she had just killed herself by drinking so much. Another
person complained that she was getting blood on the carpet. Her roommate and her
sister took her to a hospital where she has remained brain dead and comatose
since October 1996. Georgia officials have stated they intend to file murder
charges. The frothing of blood through the nose and mouth are indicative of
pulmonary edema, left heart valve failure.
On
April 30, 1998, a 27-year-old San Diego man, who regularly used GHB,
accidentally grabbed a water bottle containing GHB when he meant to retrieve a
bottle of real water. He poured a glassful and took a big drink, realizing too
late what he had done. He called his girlfriend to say he loved her, had taken
too much GHB and was going to pass out. His ''friend'' took the phone and said
not to worry, he would sleep it off. When a roommate arrived and suggested
calling 911, the ''friend,'' aka drug dealer who had made the stuff, said not to
worry, just check on him now and then. Four people left the apartment, leaving
the roommate to check on him occasionally. Three hours later he was not
breathing and medical assistance was too late. There is NO antidote for this
drug, people need to be put on life support until the effects pass. Calling 911
would likely have saved him. His family was stunned and turned to the Internet
to find out what this drug was all about. They were horrified to find that all
over the Internet it says this drug is totally safe, news reports aside. The
chat rooms say NOT to call 911, it's a waste of a trip to the emergency room,
and you'll just sleep it off. His stepmother created a web page,
ashesonthesea.com/ghb/, devoted to getting valid information out there to those
surfing the Internet and hopefully to make a difference for future victims.
There is also now a death in Santa Barbara. His girlfriend witnessed him
drinking an orange concoction of GHB (it also contained methaqualone and
methadone) after a night of partying on stimulants. He suddenly vomited and lost
control of his bodily functions, collapsing on the bed in a coma. She dressed
and left for work, later calling a friend to ''check'' on him. He was breathing
but also ''snoring'' (classic of GHB overdoses). While his friend was reading in
the other room, he died. In April 1999, a California Lutheran University student
died in his sleep; he had taken GHB as a sleep aid after reading on the Internet
that it was very safe.
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Despite
what the Internet gurus say, GHB is addictive and it is now known that
withdrawal from GHB for those addicted is life endangering. The bodybuilder
types are most susceptible to becoming addicted, since they take it regularly
from the beginning. There are documented cases of people dying from the actual
withdrawal. Furthermore, we have seen cases where these young men try to detox
on their own, suffered months of tortured existence and then end up overdosing
and dying from the painkillers and tranquilizers they self-prescribe in an
effort to avoid taking GHB. Hospitals often mistake their withdrawal symptoms
for overdoses. Addiction treatment centers have no idea how to treat this drug,
resulting in 3-5 day detox efforts that fail to help them. Long-term addiction
counseling is needed.
CONCLUSION
GHB poses
a serious challenge for law enforcement. Every officer should make an effort to
become familiar with this drug. It is an officer safety hazard, especially to
those working undercover, and should be of concern to every officer in terms of
family and friends. It is simply the hardest drug to recognize and identify
because it simply looks like water and is transported in water bottles or
colored to look like other liquids. This is now complicated even further by the
appearance of ILLEGAL analogs of GHB being sold over the counter as ''herbal''
or ''legal'' GHB, under names such as Blue Nitro, Firewater, Renewtrient,
Revivarant, Serenity, Enliven, Revitalize Plus and Remforce. In any state where
GHB is a controlled substance and where GHB is in a schedule that is covered by
an analog law, these products are simply illegal. Ingredients will be listed as
2,3H furanone dihydroxy or 1,4 butanediol or tetramethylene glycol.
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While
drugs such as cocaine, heroin and methamphetamine certainly represent the
massive side of our drug problem, GHB especially presents a unique high-risk
personal danger. Many people successfully smoke rock cocaine often and for
prolonged periods without dying. The addiction level and devastation to a
functional lifestyle of those primary drugs are certainly well known. With GHB,
one-time use of a small quantity, especially when mixed with alcohol or other
drugs, represents a stunning risk of death. Much of the information on GHB on
the Internet (more than 3,000 sites talk about GHB, according to the French
police) is dangerous and invalid. We are now learning that this drug is much
more addictive than previously known and, in fact, the withdrawals from this
drug are worse than those of heroin. Standard addiction programs do not work
safely for those addicted to GHB; withdrawal requires constant medical
supervision by someone familiar with GHB.
Does
the issue of these two drugs seem remote to your personal life? If so, consider
the fact that the 16-year-old who literally died and was revived by paramedics
from the June 1966 GHB overdose in Hollywood is the son of a retired police
officer, who didn't even know his son had tried alcohol, much less a variety of
drugs.
For more information about GHB, see
www.ashesonthesea.com/ghb. The ''viewers comments'' section is particularly
enlightening.
Ms. JACKSON LEE. Would
you describe for us the kind of impact that would happen to those of you who
fight this battle, if this was made a Schedule I, from the law enforcement
perspective?
Mr. STEVENS. For us, from
the law enforcement perspective, ma'am, the reality is that the average drug
dealer, he fears the Federal Government. He might fear the State, but the
reality is that the Federal Government, when you bring up names like DEA into
any type of work with an informant or someone, we get their attention. The
Federal Government commands their respect. A lot of our State governments and
our State laws they know are lax. They know our systems are overcrowded. They
know they are not going to serve a whole lot of time in jail, whether they are
ordered to or not.
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This
drug has been referred to as ''kiddie dope'' by many of my peers in the
business. I don't believe it is kiddie dope. It is drugs to me. People are dying
from it. I make no difference between this and crack cocaine. Different
substance. People are still dying.
But it is
interesting to note our first contact with GHB was much like the information you
just provided. We were having officers stopping, finding vehicles stopped at
intersections where all four occupants of the vehicle were passed out, with
glass vials, which is originally what GHB was coming in, laying over the
steering wheel. Initially, we thought they were intoxications, DUIs, DWIs. Later
we began to realize, after about the fourth or fifth one we were encountering,
that this was not a drinking or an alcohol problem. This was a drug problem that
we had not yet learned about.
Schedule I would
make life for us at our street level, I think, very easy. I do not know what it
would do for the DEA as far as extra work, but for us it would make it better.
The more power, the more teeth we have, the better it is. And it will take them
probably a month to realize over the Internet that it would be
scheduled.
Ms. JACKSON LEE. Thank you,
Mr. Stevens.
Professor Doering, I thank you for
your work. It has been brought to my attention that there are pharmaceutical
companies that are manufacturing GHB, in fact, overseas. And they make the
argument that someday we are going to make this a useful drug. Would you give me
a response to that, please?
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Mr.
DOERING. I am glad you offered me the opportunity to comment on that.
On the Internet that mantra is repeated over and over again: It is a legitimate
pharmaceutical drug in Europe; it is one of the most popular sedative and
sedating drugs.
To check that, I E-mailed, using
electronic means, my counterpart in Frankfurt, Germany. There is a German
product called Somniset, which is a commercially prepared and pure quantitated
dosage form. And I asked my colleague, in fact, is it true, is this drug used in
popular medical practice, or is it more of a pharmacologic curiosity? He said as
an anesthetic it is not used much any more because it has too many side effects,
so that if this drug disappeared tomorrow, I don't think it would really put a
big dent on our pharmaceutical industry or the way people are
treated.
Mr. MCCOLLUM. We will come
back if you need more questions, Ms. Jackson Lee, but we have more members we
need to go to.
Mr. Coble, you are recognized for
5 minutes.
Mr. COBLE. Thank you, Mr.
Chairman, and I want to thank the panelists for their time and their
contribution to this.
Let me think aloud for a
minute. It is my belief that for a drug to be placed in Schedule I it must pass
muster, if you will, of a three-part test: A, it must have a high potential for
abuse, that is, addiction. B, it must have no currently accepted medical use in
treatment in the United States. And, C, there must be a lack of accepted safety
for use of the substance under medical supervision.
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Now,
having said that, that is why I made my opening statement that I think we should
probably proceed very cautiously toward Schedule
I.
Now, I don't want to take any sort of action
that would make it possible for Hillory's assailant, Mr. Farias, to walk away.
But it is my belief, Mr. Chairman, and if I am wrong I will stand corrected,
that a person who is found guilty of unlawfully manufacturing or dispensing,
say, a Schedule III or Schedule IV drug, could he or she not be penalized just
as severely as if he or she had been found guilty of dispensing or manufacturing
a Schedule I drug?
Anybody want to weigh in on
that?
Mr. DOERING. Let me give it from
the pharmaceutical point of view. The big difference between III, IV and V are
essentially the penalties. As you go up the scale from III, IV and V, the
penalties get greater.
Schedule II drugs are
those that are recognized with some medical purpose but have the highest degree
of controls. The prescriptions cannot be phoned in, it has to have a new
prescription each time; there are greater degrees of
supervision.
Schedule I are those, as you
correctly said, which pass that three-part test. However, the penalties of a
Schedule I are much more severe than a Schedule II, and I think that is why the
detective was asking, give us some muscle to do something if people are
apprehended.
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Mr.
COBLE. Well, Mr. Chairman, it was my belief that there was a
provision in the law whereby that could be inserted, and I will stand corrected
if I am wrong about that, Professor. And I will back off if I am
wrong.
But Schedule I drugs simply—well, strike
that. For a drug to be in Schedule I, any clinical development is prohibited. Am
I correct about that?
Mr. DOERING. I
don't believe so. Heroin, for example, is a Schedule I controlled substance,
whereas in England it is recognized as an analgesic
agent.
Mr. COBLE. This may be subject
to interpretation, Mr. Chairman. But I think I'm right, Professor. We will talk
about this over a cold drink one time, perhaps. And maybe the DEA rep can add to
that, too.
But, Mr. Chairman, I thank you for
your time, and I thank you all for your
contribution.
Mr. MCCOLLUM. Thank you
very much, Mr. Coble.
Mr. Barr, you are
recognized for 5 minutes.
Mr. BARR.
Thank you, Mr. Chairman.
Mr. Stevens, I know you
mentioned that you felt that the experience that you had seen in the Orlando
area would be replicated in other communities all across the country. And I ask
not just yourself but other members of the panel, are there any studies that
indicate differences in demographic usage of GHB or the other drugs that we are
talking about here, that indicate particular availability or predisposition to
use it in certain parts of the country, in certain metropolitan areas?
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Mr.
STEVENS. The information I provided, I believe to the chairman's
counsel today, was some information we had received at the Orlando Police
Department. It was from the Great Lakes intelligence network, some information
they had on GHB usage. Their compilation of stuff from Los Angeles, from
California, from Texas, all pretty much shows the same
thing.
Rave scenes are held differently in the
West than they are in the East, which is much more urbanized. They have Raves
out in the middle of the desert that draw 3,000 to 4,000 people. And please,
don't misunderstand me, GHB is not simply a Rave drug. It is in the mainstream
clubs, Top 40, country, it is everywhere.
Mr.
BARR. Take just a moment and very succinctly describe exactly what a
Rave is.
Mr. STEVENS. Our definition
of the Rave, which actually began in Europe and several large cities in the
United States in the mid-'80's, the Rave scene is basically a dance party, if
you will. Very loud music, mostly techno, lot of synthesizers, a lot of bass,
colored lights, flashing lights, strobe
lights.
They originally started out as
spontaneous parties. They were passed out by hand flyers, word of mouth,
Internet, and they would spring up overnight in a field. Kids would dance from 5
o'clock to 8 in the morning. A smorgasbord of drugs if you wanted
them.
As they became more commercialized, in
Orlando we saw clubs, mainstream clubs that used to not cater to that, they
usually danced Top 40, suddenly start getting into the Rave look; colored
lights, mushrooms up on the wall, things going back and forth, strobe lights,
more techno music. As they became mainstream, more and more of the drugs started
flowing into Orlando. A lot of the DJ production companies that make these type
records and music started springing up in the central Florida area.
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Right
now the Rave is very commercialized. You will not see the spontaneous Raves like
you see out in the West, where if we had people from California they could
attest to people appearing on public land, and overnight there is a production
stage up and they are going to 7 in the morning with park rangers out there. We
don't see that, but we do see clubs now opening up catering to this going to 7
in the morning dance-till-you-drop attitude.
So
that is basically what the Raves are right now. They were all-night dance
parties, which, as far as we are concerned at the Orlando Police Department,
exist to get the drugs out. The drugs exist because of the Rave; the Rave does
not exist because of the drugs.
Mr.
BARR. Dr. Carter, if I could ask you, please, in addition to any
experience or studies that you have seen with the distribution of these drugs
varying in different parts of the country, Rohypnol, there have been some
adjustments made to the physical characteristics of Rohypnol, the insertion of
dye into the pill so that it is more apparent when it has been put in a drink.
The dissolution time has been extended. I am not sure how that is done but I
think the manufacturers have done that.
Is that
possible to do this with GHB, or feasible? And does the fact that there have
been changes made to the physical properties of Rohypnol, in your opinion,
diminish the attention that it deserves when we are looking at this
problem?
Ms. CARTER. Well, with GHB,
it is a totally different drug form. And since you can make GHB in your home,
you really can't add that dye. They are adding a blue dye to Rohypnol pills. Of
course, it is not really used in this country. But you can, with very simple
chemicals, manufacture GHB at home, so that would really not make any
change.
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We
are seeing increasing frequency in the forensic literature finding GHB. But,
again, there is a lot of education that needs to be done to detect it, to
educate the investigators and those that perform the
tests.
Mr. BARR. How about the first
question I asked, in terms of do you have any knowledge of any studies that have
been done—and this may be a better question to ask DEA in the next panel—but are
you aware of any studies that have been done that indicate a larger percentage
of usage or appearance of these particular drugs in different parts of the
country?
Ms. CARTER. Yes, there have
been increasing reports in not only major cities but small areas where they are
detecting GHB. There have been increased reports of fatalities, as well as
performing tests for hospitals and local law enforcement. It is increasing, no
doubt.
Mr. BARR. May I ask one more
quick question, Mr. Chairman?
Mr.
MCCOLLUM. Yes, Mr. Barr.
Mr.
BARR. Are we seeing any of these, and which ever one of you might be
in the best position to answer this, are we seeing the appearance of these drugs
at high schools as opposed to just Rave scenes or whatnot? Are the drugs
appearing in schools in America?
Ms.
CARTER. I believe they are. And, again, it is difficult to
detect.
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Mr.
STEVENS. One of my purchases of 173 grams of GHB was from a
17-year-old high school student. So I would
assume——
Mr. BARR. At
school?
Mr. STEVENS. Yes, he was still
in school. So I would assume, if he is selling it out there, he has probably got
a very large customer base in schools.
Mr.
BARR. Thank you.
Thank you, Mr.
Chairman.
Mr. MCCOLLUM. Thank you, Mr.
Barr.
Mr.
Hutchinson.
Mr. HUTCHINSON. Is there
great profit motivation in the selling of GHB, or is it mainly just party and
social?
Mr. STEVENS. I just got done
with the City of Tampa discussing this, sir. A lot of people in the club scene
state that it is about transcendence and experiencing a new—it is about money.
It is dope.
These guys are selling capfuls of
what is a little bit of GHB, maybe 20 percent GHB, 80 percent water, at $25 a
pop. It takes them $80 to make 7 or 8 pounds of it. I am not sure exactly how
much. You can figure if he is serving, if he goes to a Rave with a thousand
people, he might be selling 700 capfuls at $25. His overhead is nothing.
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Mr.
HUTCHINSON. That is not Internet sales or motivated, it is simply a
drug dealer out there?
Mr. STEVENS. It
is a drug dealer that has realized, hey, I have a drug that the cops really
don't know a heck of a lot about. It is easy to hide. It is easy to get rid of.
When a cop walks up, I pour it on the
concrete.
Mr. HUTCHINSON. Rohypnol or
flunitrazepam you indicated went down in its usage and its desirability because
of enhanced penalties; did I understand that
correctly?
Mr. STEVENS. Yes, sir, we
went from being flooded with ruffies, shays, that is their street name,
Rohypnol, to where we couldn't get any, unless you paid a very high price. Now,
as I say that, a week ago I bought 100 of the new pills. I have been told they
are the new dye pills.
I can attest to my
experience in nightclubs that a blue dye, in my opinion, as a police officer
working these, is not going to have any effect in a night club. It is not well
lit in a night club. Nobody is checking their Jack Daniels and Coke for blue
dye.
Mr. HUTCHINSON. Let me work
through this a little bit. They went to GHB because of the enhanced penalties
and the fear?
Mr. STEVENS. Right,
because we make 4 grams or above on Rohypnol trafficking.
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Mr.
HUTCHINSON. Which is a Florida
law?
Mr. STEVENS.
Right.
Mr. HUTCHINSON. So the State
legislature addressed that in Florida and that had a significant
impact.
Mr. STEVENS. Yes,
sir.
Mr. HUTCHINSON. But they have not
done anything yet with GHB?
Mr.
STEVENS. GHB is Schedule II for the State of Florida,
sir.
Mr. HUTCHINSON. And it did not
have the deterrent effect as the trafficking law that they passed in Florida on
Rohypnol?
Mr. STEVENS. Correct. We
have not seen a downward spiral yet. In fact, we have continued to see it up. We
are hoping to get something passed in a trafficking venue, which has a strict
minimum mandatory penalty if you are caught with a certain
amount.
Mr. HUTCHINSON. Then despite
what Florida has done, you see the need, even as a street officer, of a Federal
response to this problem?
Mr. STEVENS.
Yes, sir, I do.
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Mr.
HUTCHINSON. Now, if we hammer GHB, and they move away from that, are
the odds going to be that there is going to be another date rape drug that is
going to come along that will have the same properties that will be a substitute
for GHB or ruffies?
Mr. STEVENS. I
would like to say no, sir, but in my professional opinion, yes, they will find a
way around it. That is what they did with
GHB.
Mr. HUTCHINSON. I yield back, Mr.
Chairman. Thank you.
Mr. MCCOLLUM.
Thank you very much.
Ms. Jackson Lee, do you want
to have a follow-up question with this panel? We don't want to take another full
round, because we need to get to the other panel, but you may, if you wish. You
are the only one on your side and the author.
Ms.
JACKSON LEE. I thank you for your kindness, Mr. Chairman. Let me try
to hurry on, but I did have a couple of follow-up
questions.
First, I wanted to again thank
Hillory's family, and I wanted to ask Raul a question, because I know, in his
generosity, he provided life for others. But I would like you to tell us what
made you angry about Hillory's death or the way she died or this finding of this
GHB?
Mr. FARIAS. It was administered
to my niece for no reason. The only thing that can be done when you do this to
someone is rape or death. That is what upset the whole family in the first
place. There was no sense in it. And that is the answer to that question. But I
would like to comment on another thing that this gentleman said over here, if
you don't mind.
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Ms.
JACKSON LEE. Go ahead.
Mr.
FARIAS. There will be another date rape drug after GHB, but that does
not mean that we cannot make this a Schedule I. And that is what we are here
for. Because no matter what, there is going to be drugs out there for the rest
of our lives, and it is our job to go out there and make people accountable. And
that is what upset our family, is that there is no law that is holding anybody
accountable.
Ms. JACKSON LEE. Thank
you.
And Dr. Carter, I appreciate your overview
of the detriment of many drugs, and you noted alcohol and others. I think people
in hearing your testimony, who would want to oppose the legislation that we are
presenting today would raise that question, frankly; that alcohol abused may
result in the same reactions.
Would you help
distinguish, by assessing the potency of GHB in its certain amounts, whether or
not GHB in a small amount can be potent, or used as it is presently used and
abused raises a higher level of concern.
Ms.
CARTER. Well, certainly GHB is dose-related. When you are given GHB,
you don't know what the concentration is, like other illicit drugs that have
been mapped out somewhat for alcohol. Certainly GHB is more easily concealed in
a soft drink or other liquid. Usually, alcohol certainly has a taste to it. And
the whole idea is the concealment.
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But
from the legal standpoint, GHB will disappear more rapidly from the body than
alcohol does. You are literally looking at 12 hours in order to document—there
is an unknown chemical in the person's blood or in the person's urine and,
therefore, making it very difficult to preserve the chain of custody and to
record evidence that a crime has been
committed.
Ms. JACKSON LEE. So it
helps if we have, and I know you are not a lawyer, to have it as a Schedule I to
immediately give police and others the evidentiary tools they may need in order
to begin looking for it?
Ms. CARTER.
Yes, certainly for the educational environment, and also for those who have to
detect the drug, to have the proper equipment available it will demand, because
there is so much out there. We are seeing the tip of the iceberg. It is almost a
tandem analysis in performing for the known illicit
drugs.
This will not be found from doing an
illicit drug screen that would detect cocaine and morphine. It has to be done in
a different method. And we do feel, as forensic pathologists, we are missing a
majority of cases.
Ms. JACKSON LEE.
Dr. Doering, you made an important point. You said that the FDA, and you correct
me if I have misinterpreted your words, took it off the market. It was on the
market; took it off the market. Could you just, for the record, restate that for
me, please?
Mr. DOERING. Yes, it was
on the market not as a drug but as a nutritional supplement. Now, that is
another story, because there are a lot of dangerous drugs, in my opinion,
masquerading as nutritional supplements. But even this one before the Dietary
Supplement Health Education Act of 1994, before that it was sold as a
nutritional supplement. And FDA was very, very concerned, and has reissued its
warning that this is not a drug, has never been approved as a drug in this
country, but is readily available.
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And
if you don't believe me, try this web site: WWW.GHBKIT.COM, and you will get all
you want of the ingredients to manufacture this
drug.
Ms. JACKSON LEE. Do you consider
it potent, GHB?
Mr. DOERING. Oh,
absolutely, very potent medication.
Ms.
JACKSON LEE. Do your attackers attack you for being way off the mark
and providing misinformation?
Mr.
DOERING. Oh, no question about that. We are public enemy number one
for the purveyors of misinformation. But the problem with street level samples
of this drug, you don't have any idea what the potency is. It would be a lot
like going to the pharmacy and getting a prescription for penicillin and them
handing you a scoop and saying scoop out what you think is the right dose. That
is the difference between medical GHB and street level
GHB.
Ms. JACKSON LEE. Thank you very
much, Mr. Chairman, and I thank all the witnesses very
much.
Mr. MCCOLLUM. We are not going
to go to a second round, as I said. I recognized Ms. Jackson Lee because of the
two reasons I mentioned.
But we want to thank
this panel for being here today. You have all contributed a great deal, and
several of you have come quite a distance, so thank you again for coming.
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I
will now introduce our second panel, which really consists of only one witness,
but a very important witness, Mr. John King who is the Deputy Assistant
Administrator in the offices of Diversion Control of the U.S. Drug Enforcement
Administration.
Prior to his appointment as the
Deputy Assistant Administrator, he was the Assistant Special Agent in charge for
DEA's St. Louis field division. During his time in Washington, D.C., he served
as the Associate Deputy Assistant Administrator in the Office of Information
Systems, as an inspector with the Office of Inspections, and as the senior
narcotic enforcement advisor to the Assistant Secretary of State on
International Matters. Mr. King also served overseas as the country attache in
New Delhi, India. Mr. King received his Bachelor of Arts degree from Randolph
Macon College in Virginia.
I want to thank you,
Mr. King, for being with us today. Your entire testimony will be submitted into
the record. Without objection, it is so ordered. And if you would please
summarize your statement for us and give us your thoughts, if you can, in 5
minutes or so. We might be a little flexible if you need more time. I know I
have read your statement, and perhaps others have too, so it would be helpful to
us for you to be relatively brief.
So, please
proceed as you see fit.
STATEMENT OF JOHN H. KING, III, DEPUTY ASSISTANT
ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, DRUG ENFORCEMENT ADMINISTRATION,
U.S. DEPARTMENT OF JUSTICE
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Mr.
KING. Thank you, Mr. Chairman. Thank you members of the subcommittee.
I appreciate the opportunity to appear before the subcommittee today on the
subject of use of drugs in sexual assault
cases.
I have already submitted my prepared
statement. I will try to summarize that prepared statement with just a few quick
pages here.
There are three unique substances the
DEA is reviewing for possible control for their emergence in trafficking and
abuse patterns. These drugs, flunitrazepam, ketamine, and gamma hydroxybutyrate,
or GHB, have also been associated with reports of sexual assault. It is
important to note that all three of these substances also have been abused for
their psychoactive effects.
Flunitrazepam belongs
to the benzodiazepine class of drugs. Its pharmacological effects include
sedation, muscle relaxation, and a reduction in anxiety. Flunitrazepam has never
been approved for medical use in the United States. However, it is legally
prescribed in over 50 countries outside of the United
States.
It was placed in Schedule IV of the
Controlled Substances Act in 1984 due to international treaty obligations. At
that time there was little abuse of flunitrazepam in the U.S. More recently,
with the increase in trafficking and abuse, DEA began to consider the merits of
transferring flunitrazepam into a more restrictive
schedule.
As part of the administrative
scheduling process, the DEA submitted data on the abuse and trafficking of
flunitrazepam to the Department of Health and Human Services in April 1996. In
January, 1997, HHS provided DEA with a scheduling recommendation which stated
that although flunitrazepam had no accepted medical use in the United States,
that its abuse potential was the same as other benzodiazepines, consistent with
Schedule IV control.
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Flunitrazepam
is abused by high school and college students, gang members, Rave party
attendees, heroin and cocaine abusers. The drug produces profound intoxication,
boosts the high of heroin and modulates the effects of cocaine. It is also
commonly used in combination with alcohol, which potentiates its toxic
effects.
Flunitrazepam abuse may cause
drowsiness, dizziness, loss of motor control, lack of coordination, slurred
speech and confusion. It also causes anterograde amnesia, and is particularly
problematic when flunitrazepam is used to aid in the commission of sexual
assault. Chronic use of flunitrazepam can result in physical dependence and
withdrawal symptoms when the drug is
discontinued.
Although it is difficult to
estimate the magnitude of the problem, the DEA has identified 20 flunitrazepam
facilitated rapes between 1994 and 1997. If flunitrazepam exposure is to be
detected, the screening must take place within 72 hours of ingestion. This
problem is compounded by the onset of the amnesia after ingestion, which causes
the victim to be uncertain about the facts surrounding the
rape.
The DEA has documented approximately 4,500
Federal, State, and local law enforcement investigations involving the
distribution or possession of flunitrazepam in 38 different States. The majority
of these cases are in Florida and Texas. Data from the Drug Abuse Warning
Network shows that there were 88 emergency room episodes involving flunitrazepam
from 1994 to 1996. Our report to Congress on the abuse and trafficking of
flunitrazepam expressed our concern over problems associated with the drug and
its use in sexual assault encounters.
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DHHS,
Department of Health and Human Services, as part of their administrative
process, recommended that flunitrazepam remain on Schedule IV. After a careful
analysis of the relevant data, as well as the DHHS recommendation, the DEA
concluded that we did not have sufficient grounds administratively to reschedule
flunitrazepam as a Schedule I substance. Legislative rescheduling, however,
remains an option.
A number of other actions have
been taken to address this problem. The Drug-Induced Rape Prevention and
Punishment Act of 1996 made it a crime to give an unconsenting individual a
controlled substance with the intent of committing a violent act, including
rape, against that individual. It also established Schedule I penalties for
possession and distribution of flunitrazepam.
In
addition, the United States Customs Service has been seizing all flunitrazepam
at border points of entry in response to the growing abuse and trafficking
problem. Several States have rescheduled flunitrazepam on Schedule I.
Hoffman-LaRoche, the manufacturer of the trade name of Rohypnol, has also
cooperated with law enforcement in several areas to target the use of this drug
in rape cases. The trafficking and abuse of flunitrazepam continues and is a
serious concern.
The current uncontrolled
substance associated with drug-induced rape is GHB. It is also being abused for
its psychoactive effects, and we believe it should be controlled under the CSA.
We are currently waiting for scientific and medical evaluations from HHS on the
scheduling recommendation of GHB, as required by
law.
GHB is abused for its ability to produce
euphoric states and alleged role as a growth hormone. In 1990, the Food and Drug
Administration became aware of the overdoses and related problems with its use
and issued a advisory declaring GHB unsafe and illicit. It currently has not
been approved for marketing but is under investigation for the treatment of
narcolepsy.
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Ingestion
of GHB produces dose-dependent drowsiness, dizziness, nausea, amnesia, visual
hallucinations, hypnotic effects, convulsions, severe respiratory depression and
coma. Medical examiners have reported 26 fatalities in which GHB was detected,
and in many of these deaths GHB was used in combination with
alcohol.
Over 1,000 GHB-related cases have been
documented by Federal, State, and local law enforcement officials. GHB abuse
often occurs in bars, nightclubs, Rave parties and gyms by teenagers and young
adults who frequent these locations. During 1995 and 1996, there were 411
emergency room episodes involving GHB. The DEA is aware of at least 9 sexual
assault cases with 19 victims involving GHB.
GHB
does leave the body very quickly and it makes detection of this very, very
difficult in the sexual assault cases. Almost all of the GHB encountered by law
enforcement has been clandestinely manufactured. Although GHB is not controlled
at the Federal level, 17 States have controlled GHB in either Schedule I, II or
IV.
Ketamine is the only drug of the three
discussed that has been approved for marketing in the U.S. Though not
controlled, it is primarily used in the field of veterinary medicine as a
fast-acting general anesthetic. The pharmacological profile is essentially the
same as phyncyclidine, or PCP, which leaves the individual anesthetized,
detached or disconnected from their pain and environment. It has both analgesic
and amnesic properties.
As a drug of abuse,
ketamine has become common at Rave parties. 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.
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There
has been no reported clandestine manufacturing of ketamine, and to date it has
been diverted primarily from distributors and veterinarians. From 1993 to 1996,
82 emergency room episodes have been reported with a detection of ketamine. The
DEA is aware of one incident in which ketamine was used to facilitate rape. This
drug, like flunitrazepam and GHB, may be be used by individuals intent upon
committing sexual assault due to its effect on
victims.
HHS has recommended, on two occasions,
that ketamine be placed in Schedule III of the CSA, based largely on the
pharmacological profile of the drug. On both occasions the DEA determined that
the incidence of actual abuse was not sufficient to sustain the proposed
scheduling. Ketamine's recent emergence as a drug of abuse has prompted the DEA
to reevaluate our position.
I would like to
conclude with some general observations.
Due to
the nature of the crime of rape, for a variety of reasons a significant
percentage of rapes go unreported. These problems are compounded in drug-induced
rape.
The DEA supports the rescheduling of
flunitrazepam in the control of both GHB and ketamine. These drugs are being
abused for their psychoactive effects and used by rapists to incapacitate their
victims. This abhorrent activity makes Federal control action
critical.
I would like to thank the subcommittee
for the opportunity.
[The prepared statement of
Mr. King follows:]
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PREPARED
STATEMENT OF JOHN H. KING, III, DEPUTY ASSISTANT ADMINISTRATOR, OFFICE OF
DIVERSION CONTROL, DRUG ENFORCEMENT ADMINISTRATION, U.S. DEPARTMENT OF
JUSTICE
Mr. Chairman and Members of the
Subcommittee: I appreciate the opportunity to appear before you today on the
subject of controlled substances used to commit date rape. One controlled
substance that has been associated with sexual assaults, including date rape, is
flunitrazepam. Flunitrazepam, commonly known as Rohypnol, is currently a
Schedule IV controlled substance, which is manufactured by Hoffman-La Roche. I
will also provide comments on two other drugs, gamma hydroxybutyrate (GHB) and
ketamine, that DEA is reviewing for possible control. It is also important to
note that all three of these substances are abused for their psychoactive
effects. However, the abuse of these drugs is not comparable to the abuse of
cocaine, heroin and
methamphetamine.
Flunitrazepam 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 administration, and last approximately 4 to
6 hours. Some residual effects can be found 12 hours or more after
administration.
Flunitrazepam has never been
approved for medical use in the United States, therefore, 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.
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Flunitrazeparn
was placed into Schedule IV of the Controlled Substances Act (CSA) in 1984 due
to international treaty obligations. At that time there was little abuse of
flunitrazepam in the U.S. However, over the last several years, DEA has been
concerned with the problem of flunitrazepam abuse and approximately three years
ago, began to consider the merits of transferring flunitrazepam to a more
restrictive schedule which would result in increased penalties. Currently,
flunitrazepam remains in Schedule IV of the Federal CSA, which also contains
such drugs as Valium, Librium, Xanax and Halcion. As part of the administrative
scheduling process required under the CSA, the DEA submitted its data on the
abuse and trafficking of flunitrazepam to the Department of Health and Human
Services (DHHS) in April, 1996. Along with DEA's document was a request to DHHS
for a scientific and medical evaluation and a scheduling recommendation. In
January, 1997, after the appropriate scientific and medical review, DHHS
provided its scheduling recommendation to 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
recommendation of DHHS was that flunitrazepam remain in Schedule
IV.
Several different populations that abuse
flunitrazepam have been identified in the United States. Flunitrazepam is abused
by 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. To a lesser extent, it is
also abused by crushing, the tablets and snorting the powder. It is commonly
abused in combination with alcohol.
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 the withdrawal syndrome
when the drug is discontinued. Flunitrazepam impairs cognitive and psychomotor
function which affects 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.
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Data
from the Drug Abuse Warning Network (DAWN) shows that there were 88 emergency
room episodes involving flunitrazepam during the period January 1994 through
December 1996. All but eighteen of these episodes occurred in the Miami area.
Most of the episodes also involved other drugs, including
alcohol.
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 eight individuals
have been convicted of sexual assault in five state court cases in which there
was evidence that flunitrazepam was used to incapacitate the victim. There are
at least an additional 14 other sexual assault cases. from 1994 to 1997 in which
there is evidence to suggest that flunitrazepam was used in committing sexual
assault. These cases have not gone to trial.
For
a variety of reasons, it is difficult to estimate just how large a problem
flunitrazepam-facilitated rapes are 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 assays available in the United States. If flunitrazepam exposure is to
be detected at all, urine samples need to be collected within 72 hours and
subjected to sensitive analytical tests. The problem is compounded by the onset
of amnesia after ingestion which causes the victim to be uncertain about the
facts surrounding the rape. This uncertainty may lead to critical delays or even
reluctance to report the rape and to provide appropriate biological samples for
toxicology testing.
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In
recent years, the increased popularity of flunitrazepam has led to an escalation
in the 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.
DEA has documented approximately 4,500
Federal, state and local law enforcement cases involving the distribution and/or
possession of flunitrazepam in 38 states. The largest number of cases is
concentrated (1,600) in Texas 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 170 cases
involving over 530,000 flunitrazepam tablets for the period of January 1, 1993
to April 30, 1998. 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. The
decline in seizures in 1996 and 1997 was primarily the result of increased
Customs enforcement action at the points of entry from Mexico. While the number
of tablets seized declined during 1996 and 1997, during the first quarter of
1998, 52,000 tablets were seized. This is more than were seized in all of
1997.
The two milligram (mg) pharmaceutical
tablet had, until recently, 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 has been a significant reduction in encounters with the pharmaceutical two
mg tablets but increases in encounters with the one mg pharmaceutical tablets
and with counterfeit tablets containing two mgs of flunitrazepam. The appearance
of the counterfeit tablets demonstrates that there is an established illicit
market in the U.S. for the two mg tablet.
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A
special review of the appropriate schedule for the control of flunitrazepam was
initiated as required by the Drug-Induced Rape Prevention and Punishment Act of
1996. DEA prepared a report to Congress on the abuse and trafficking of
flunitrazepam and the appropriateness and desirability of rescheduling it into
Schedule I of the CSA. The report expressed concern over the problems associated
with flunitrazepam, particularly its use in sexual assault incidents. It also
noted that the DHHS provided a scientific and medical evaluation of the
available data on flunitrazepam and, based on this evaluation, recommended that
it remain in Schedule IV. After careful analysis of the relevant data, as well
as the DHHS recommendation, the DEA concluded that we did not have sufficient
grounds to reschedule flunitrazepam as a Schedule I substance administratively.
Legislative rescheduling at the Federal and state levels, however, remains an
option. Some individual states, such as Florida, have decided that current
controls are inadequate to address the abuse and trafficking of flunitrazepam
within their jurisdictions and have rescheduled it into Schedule I either
through an administrative process or by legislation. Schedule I at the state
level is comparable to Schedule I at the Federal level. In our report to
Congress on flunitrazepam, we confirmed our support for such legislative action
at both the state and Federal level.
Even though
DEA has been unable to reschedule flunitrazepam, there have been a number of
other actions taken to deal with this problem. 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 all flunitrazepam encountered at border points of entry
in response to the growing abuse and trafficking problem and the fact that it is
not approved for use in this country.
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At
the state level, 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.
The manufacturer of Rohypnol,
Hoffman-La Roche, has cooperated with law enforcement in several areas to target
the use of this drug in rape. The firm has changed their production from two mg
tablets to one mg tablets and has developed a new formulation which contains a
dye that will make it easier to detect that the drug has been placed in a
victim's drink. However, the dye will be much less effective if the drink is
served in an opaque container or if the drink itself is dark in color. In
addition, this new formulation has only been approved in a few countries and the
company is still seeking approval in other countries, including Mexico.
Hoffman-La Roche has also launched a public information campaign concerning the
potential use of its product in the commission of criminal acts and has made
available a drug testing service for law enforcement agencies in the U. S. to
assist authorities in investigating cases in which flunitrazepam is suspected of
being used in a criminal act.
Since our report to
Congress on this issue in November, 1997, the trafficking and abuse of
flunitrazepam have continued. There is no doubt that the abuse of this drug is a
serious concern. However, in light of the DHHS recommendation, we believe that
there is still insufficient relevant data to support rescheduling flunitrazepam
into Schedule I administratively.
Flunitrazepam
is not the only substance which has been associated with drug-induced rape. A
currently noncontrolled drug, GHB, has been used for this purpose. GHB is also
being abused for its psychoactive effects and, in our opinion, should be
controlled under the CSA. DEA has conducted the analysis required under the CSA
for control, and we are waiting for completion of the scientific and medical
evaluation and scheduling recommendation from the DHHS. However, the
administrative process to control new drugs of abuse is lengthy, and it is not
known when GHB will be controlled.
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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 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. GHB has not been approved by the FDA for
marketing, but 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 by the FDA, 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 ' unconsciousness can occur in as little as 15
minutes and profound coma can occur within 30 to 40 minutes after-oral
ingestion. Emergency room patients often regain consciousness within 2 to 4
hours. 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. In addition, Medical
Examiners have reported 26 fatalities in which GHB was detected in the decedent.
Many of these deaths involved the use of GHB in combination with
alcohol.
In recent years GHB has emerged as a
significant drug of abuse throughout the United States and a number of foreign
countries. Since 1993, more than 1,000 GHB-related cases of abuse, overdose,
possession, manufacturing, diversion and trafficking have been documented by
Federal, state and local officials. GHB is frequently taken with alcohol or
other drugs that heighten its effects, and it is often found at bars, night
clubs, rave parties and gyms. The primary users are teenagers and young adults
who frequent these establishments. 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. Abuse of
GHB has led to an increasing number of emergency room episodes reported to DAWN.
From 1992 through 1996, there have been 411 GHB-related DAWN emergency room
mentions, with 257 of them occurring in 1996. Alcohol and GHB mutually enhance
each other's toxic effects and most of the mentions involved the use of GHB in
combination with alcohol.
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The
DEA is aware of at least nine sexual assault cases involving 19 victims under
the influence of GHB in Florida, Texas, Louisiana, Wisconsin, California,
Michigan and Maryland. In seven of these nine cases, GHB was detected in the
urine of the sexual assault victims. However, like flunitrazepam, GHB's
involvement in rape cases may go unreported or unsubstantiated. GHB is quickly
eliminated from the body making detection in body fluids unlikely, and its fast
onset of depressant effects may render the victim helpless to recall details of
the attack.
Almost all of the GHB encountered by
law enforcement has been produced in clandestine laboratories. GHB synthesis
requires no special knowledge of chemistry, the precursor chemicals
(gamma-butyrolactone and lye) are inexpensive and readily available, and the
process can be accomplished without special equipment by a simple ''one-pot''
stove top method. In fact, GHB ''kits'' containing the precursor chemicals are
available for sale on the Internet. DEA is aware of at least 43 illicit
laboratories seized since January 1997 in which GHB was being synthesized. 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. Indicators
suggest that GHB abuse and trafficking is escalating and poses a serious health
and safety risk.
Although it is not yet
controlled at the Federal level, seventeen states have already controlled GHB:
Rhode Island, Georgia, Hawaii, Illinois, Louisiana, Nevada, Wisconsin, Michigan,
Delaware, Idaho in Schedule I; Florida, California and Indiana, New Hampshire in
Schedule II; and Tennessee, Alaska and North Carolina in Schedule IV. In
addition, Texas and New Jersey have criminalized the sale and possession of GHB
and placed in the same penalty group as LSD and marijuana.
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The
final drug I want to discuss, ketamine, also is not controlled. It is the only
one of the three which has been approved for marketing in the U.S. and it is
primarily used 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 and
amnesic properties. The use of ketamine as a general anesthetic for humans has
been limited due to its adverse effects including the delirium and
hallucinations which some experience when 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 touted as better than that of LSD or PCP because it lasts only 30–60
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 the same
effect.
''Special K'' is prepared by evaporating
the liquid from the legitimate pharmaceutical injectable product and grinding
the residue into a powder. There has been no reported clandestine manufacture of
ketamine. 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 in
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.
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Since
1993, the frequency of law enforcement encounters as well as emergency room and
medical examiner's reports has increased, indicating that the abuse of ketamine
is growing. Abuse of ketamine is reflected in the 82 emergency room episodes
reported to DAWN during the period 1993–1996. 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, we are 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
lead to under-reporting the use of flunitrazepam and GHB in rape apply to
ketamine as well.
The Department of Health and
Human Services 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 was not sufficient to sustain the proposed
scheduling. Ketamine's recent emergence as a drug of abuse has prompted the DEA
to reevaluate its placement in the CSA, and we have requested a new scientific
and medical evaluation and scheduling recommendation from DHHS. At least 14
states have already controlled ketamine; California, Connecticut, Delaware,
Florida,, Hawaii,, Illinois,, Louisiana, New Hampshire, New Jersey, New Mexico,
New York, Oklahoma, and Wisconsin have placed it in Schedule III and Missouri
has placed it in Schedule IV.
I would like to
conclude with some general observations. The Subcommittee's concern with the use
of these drugs in rape cases is important and certainly timely as their abuse
and trafficking trends continue to be on the rise. DEA shares this concern. Some
individuals are using these drugs to take advantage of helpless victims. This
use is abhorrent and cannot be tolerated by society. Unfortunately, DEA's task
of evaluating and determining the level and extent to which these drugs are used
to facilitate rape is almost impossible. Due to the nature of the crime of rape,
it is frequently stated that, for a variety of reasons, a significant percentage
of all rapes go unreported. This problem is exacerbated in the instance of
drug-induced rape. The very qualities which make these drugs attractive to the
rapist, for example: amnesia, loss of inhibitions, inability to control what is
happening, make it less likely that this type of rape will be reported and
documented. A more fundamental problem is the lack of data base information on
drug-induced sexual assaults and the need to protect the privacy of victims.
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This
presents us with a situation in which we do know that these drugs are clearly
capable of facilitating rape. For example, in the recently publicized Spitzer
case, there was evidence that one of the rapes was facilitated by using
flunitrazepam.
We support the rescheduling of
flunitrazepam and the control of both GHB and ketamine. These drugs are being
abused for their psychoactive effects and both flunitrazepam and GHB are being
used by rapists to incapacitate their victims. Certainly ketamine can also be
used for this same purpose. This makes the need for Federal control action
critical. Unfortunately, in light of the DHHS recommendation regarding
flunitrazepam, we believe that we do not have the data to support rescheduling
the drug through the administrative process. In the case of GHB and ketamine,,
we have collected the data and are waiting for the recommendations of DHHS.
However, it may well be several years before these drugs are brought under
control. Until that happens, there'' will be no sanctions under the CSA for the
abuse and trafficking of GHB and ketamine and they will continue to be readily
available for use by rapists.
Mr. Chairman, in
closing, I would like to thank you and the Subcommittee for your continued
support for the DEA. I also thank you for providing me with the opportunity to
offer the DEA's position and comments on the very serious problem of
drug-induced rape. I will be happy to answer any questions you may
have.
Mr. MCCOLLUM. Thank you very
much for coming and being with us today, Mr. King. I will yield myself 5 minutes
in the question period.
Back in 1996, we
basically passed a bill that gave the same penalties for trafficking in
flunitrazepam as would be the case had it been a Schedule I drug. And I would
suggest that we could do the same thing with GHB, even if it were not
rescheduled, if it were important to the continued research that Dr. Doering
said is being done on narcolepsy and other aspects of that possible use for a
constructive purpose.
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Yet
you have testified today that you think even flunitrazepam ought to be moved on
up to Schedule I, even with those tough penalties that are present for it. Under
the law, it now reads Schedule I and II drugs and specifically the names
flunitrazepam get these increased penalties.
What
would be the significance? Why does DEA feel that even though flunitrazepam
already has the tougher penalties, it needs to be rescheduled as Schedule I?
And, number two, what would be the distinction here with respect to scheduling
GHB, or rescheduling it somewhere with respect to how that would affect the
research that Dr. Doering was discussing? And could we solve the potential
problem of not being able to do that narcolepsy research by simply increasing
the penalties as we did with flunitrazepam?
Mr.
KING. There are many drugs that are investigative, that are new drug
registrations, like marijuana, like LAAM, initially. Now, they start at Schedule
I, and as they are approved for use by the FDA—we will talk about Marinol and
LAAM right now—they move down the schedule. They suggest a schedule, we agree
upon it, and then it is done that way. LAAM was once a Schedule I; now it is a
Schedule II. Used in methadone clinics. Marinol, once a Schedule I, now it is a
Schedule II, used for people that have a problem
with——
Mr. MCCOLLUM. Whatever. That's
all right.
Mr. KING. But I do not
think that would affect—the research could go on with no problem whatsoever. All
you would have to do is upgrade security and the reporting requirements, that is
all. But the research could continue. And if it was approved by the FDA for
narcolepsy, they could move it down to the appropriate schedule.
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Mr.
MCCOLLUM. Let's ask it the reverse way, then. If there is no harm to
research in scheduling a Schedule I, what harm is there in law enforcement if,
instead of rescheduling it to Schedule I, we just zap the same penalties on that
particular drug and leave it where it is? What is the significance of getting it
scheduled higher or to a I level, if you will, except for
penalties?
Mr. KING. Well, there is
penalties and there is perceptions. And the perceptions are that the higher the
drug is, or the lower the drug is on the schedule, the more harmful the drug is,
which is absolutely true.
In addition to that,
most States mirror the Federal system, and it is very easy for them to move a
drug into a Schedule I, like Florida. They can move a drug, any drug, or GHB,
into Schedule I very easily if the Federal Government schedules it as Schedule
I.
Mr. MCCOLLUM. As you know,
Rohypnol, the flunitrazepam drug that is most commonly discussed, Mexico has
just decided to make it available chemically only in an altered state, which
causes it, if it is put in a drink, to turn blue, as I understand it. First,
what is your reaction to that? Might that be done in other countries? Would it
be helpful?
I heard Detective Stevens say
something to the effect that he didn't think that would make any difference at
all, as far as the date rape Rave scene is concerned, because people couldn't
see that it was blue. Is this a significant thing Mexico has done? Is it
something you would encourage other countries to do? Is it significant at
all?
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Mr.
KING. Actually, sir, it is a company, Hoffman-LaRoche, that did this.
We have been in negotiations with them for some time to do certain things, and
they have been extremely helpful to law enforcement. This was one of the things
that they came up with.
It is not going to work
every time. Obviously, if you put it in a dark drink, you can't see it. You
cannot put it in white wine in a lighted bar that I might go to. It is just one
of the things that they tried to do to not convey that their drug is a date rape
drug.
Mr. MCCOLLUM. So you would say
it is a positive thing, but it is not a fully effective mechanism for alerting
people to the fact that this is in their
drink?
Mr. KING. Yes,
sir.
Mr. MCCOLLUM. So the fact that
Mexico has made it available only in the altered state, you would hope that
others might follow suit, I assume, other countries where Rohypnol is legal? Is
that something you would encourage?
Mr.
KING. I don't think it has been approved for use in that altered
state in Mexico yet, sir.
Mr.
MCCOLLUM. Oh, it hasn't been yet?
Mr.
KING. No, sir, I think it is only in certain other countries.
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Mr.
MCCOLLUM. My staff was saying last week it was, but I don't know. We
will find out sooner or later. It matters not at this point, I suppose, for the
purpose of this hearing.
Ms. Jackson Lee, you are
recognized for 5 minutes.
Ms. JACKSON
LEE. Thank you very much.
Thank you, Mr.
King, for your testimony. It seems, in your testimony, that there is some
collaboration between the DEA and the FDA. You are not at odds. You can work
together.
And I think there are two themes
running through this hearing and typically running through any hearing that
deals with rescheduling of drugs. You want to be fair and balanced. You want to
have all the facts. You want to ensure that if there is something meritorious
that someone should see and look for that you take that into consideration and
weigh the pros and cons.
In listening to the
testimony, I wish to pose this question. One is, simply, do you all work
together? And can you state again the kind of actions that might occur if in the
long run FDA, in its research, determined some meritorious use for GHB? What
then would be the process if this drug had been rescheduled or scheduled as
Schedule I?
Mr. KING. Well, we do work
together. And even though we work together on mutual problems, when it comes to
scheduling, we are supposed to do it independent from each other.
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Ms.
JACKSON LEE. I understand that.
Mr.
KING. On a substance like GHB, when it has this tremendous abuse
potential, if it was moved to Schedule I and then FDA approved it for use, I
think a Schedule II would be appropriate.
Ms.
JACKSON LEE. But what I glean from that is this is not a forever,
forever bar. If out of this hearing and the ultimate wisdom of this committee
and this body that it was moved to a Schedule I, we know that there are measures
upon which it could be considered something else if there was some meritorious
argument to be made by the FDA. You have seen this
occur?
Mr. KING. Oh,
absolutely.
Ms. JACKSON LEE. Do you
think the scheduling of GHB to Schedule I would save
lives?
Mr. KING.
Absolutely.
Ms. JACKSON LEE. There was
a point that Mr. Stevens made that I found very interesting. I think he has
done, in his area, a very good job. But he said something that caught my
attention. ''When you hear the Feds are involved, people get pretty
serious.''
You are in DEA. You are all over the
country. You are in my southern district of Texas. What is your impression, in
working with local law enforcement, when a drug is Schedule I, and dealing with
it as it relates to the impressions by those who use it and sell it or traffick
it? How does the Schedule I help in law enforcement?
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Mr.
KING. Most of the time the Federal sentencing guidelines are much
heavier than the State and local guidelines. In most of my experience in DEA for
the last 29 years, it has been working with State and local law enforcement
officials. DEA does not have enough agents just to continue to do investigations
by themselves, so in just about all the divisions we have multiple task forces.
They enjoy having those kind of powers; they enjoy getting somebody with an
ounce of crack cocaine and watching them really squirm when they walk into a
Federal Courthouse rather than a State courthouse. It makes a big
difference.
Ms. JACKSON LEE. Does it
help make the case, as well?
Mr. KING.
Oh, absolutely.
Ms. JACKSON LEE. One
of the points of my legislation, and I think noting the age of some of the
participants or the users of this drug, it seems it may be prevalent among
teenagers, I think part of our responsibility is prevention, educating people
not to use it. Does the idea get on the
street?
Because a lot of people argue against
that. Nobody cares whether or not cocaine is at its level, or crack. But in the
kind of population that is using GHB, do you think it could get on the street,
hey, this is a Federal crime? Do you think it would bring down the usage of it
or frighten people away from it?
Mr.
KING. Well, we in DEA think that demand reduction is very important.
But education, getting the word on the street, like the detective said, it would
be on the street immediately that DEA, or like when Florida raised their
scheduling to Schedule I with Rohypnol, it was difficult to find Rohypnol. Price
went way up. We saw that in 1996. That is when Florida did their thing, and
Customs started stopping all the Rohypnol on the border. It was very, very
effective. In 1997 we saw very little Rohypnol, and now we are starting to see
it creep back up again.
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The
idea of educating the criminals is one side, but the idea of educating the
children is much more important, and we have a lot of those programs going on.
My staff, we deal with rape crisis centers. We are helping DOJ right now do a
videotape concerning concerning sexual
assaults.
Ms. JACKSON LEE. Let me read
one question into the record and I think you can answer this yes or
no.
If GHB is not scheduled as I or II, then drug
analogs will remain prevalent. Drug analogs of GHB are just as potent and
dangerous as GHB itself. Do you believe this drug and its analogs are dangerous
enough so that they should be removed from the illegal market in every way
possible?
Mr. KING. The drug analogs
of GHB?
Ms. JACKSON LEE.
Yes.
Mr. KING. I do not have an answer
for that question.
Ms. JACKSON LEE.
Would you research that question for us,
please?
Mr. KING. Yes, I will, and I
will get back to you.
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Ms.
JACKSON LEE. Thank you.
Mr.
MCCOLLUM. Thank you, Ms. Jackson
Lee.
Mr. Barr, you are recognized for 5
minutes.
Mr. BARR. Thank
you.
Mr. King, is either GHB or Rohypnol approved
by the FDA for use in this country?
Mr.
KING. Rohypnol has never been brought forth to the FDA to be
manufactured or distributed in the United States by Hoffman-LaRoche. GHB, no. It
is only in a research grant right now.
Mr.
BARR. We talked a little bit about some changes that have been made
to Rohypnol, its physical properties, the way it dissolves, the coloring, and so
forth. How would that change the scheduling of a drug? Would that relate to its
potential for abuse? Why is that relevant, or is it
relevant?
Mr. KING. I think back in
1997 we were having discussions with Hoffman-LaRoche, not only here in
Washington but also in Switzerland, over the concern of their product. They were
trying to find ways to get rid of that title as a date rape drug. They were
going out of their way to do education courses, drug samplings, urine testing
free for police officers and, in addition, they wanted to try this new compound
so that you couldn't put it in a glass of water like this and you could detect
it very easily. So I think what they were trying to do was responsible.
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As
I told the chairman, it is not 100 percent effective but it is
responsible.
Mr. BARR. What is the
relevancy of that, if any, to where a drug ought to be
scheduled?
Mr. KING. None,
sir.
Mr. BARR. Do either GHB or
Rohypnol, or its chemical name, flunitrazepam, have any currently accepted
medical use for treatment in the United
States?
Mr. KING. No,
sir.
Mr. BARR. That being the case, is
there any reason why these drugs should not be properly scheduled under the
controlled substances schedule?
Mr.
KING. In which way, sir? I'm sorry. They should both be Schedule
I?
Mr. BARR. I am not saying any
particular schedule, that is my next question, but is there any reason that both
of these drugs should not be considered controlled substances under 21 U.S.C.
A(12) 1, the Schedule of Controlled Substances? Is there any reason why they
both should not be there somewhere?
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Mr.
KING. Well, flunitrazepam is scheduled,
sir.
Mr. BARR. I understand that. GBH
is not.
Mr. KING. That is
correct.
Mr. BARR. I am saying in your
opinion is there any reason why both of them should not be scheduled there?
Should both of them be somewhere in the schedules of controlled
substances?
Mr. KING. Yes,
sir.
Mr. BARR. That being the case, in
your best opinion, and you might have covered this in various ways with other
questions and in your testimony, but just as sort of a final question here,
given the various characteristics that place a controlled substance in one of
five schedules, where would the best place to place GHB and flunitrazepam be, in
which schedule?
Mr. KING. Schedule
I.
Mr. BARR. Both of
them?
Mr. KING. Yes,
sir.
Mr. BARR. And that is based on
your concerted expert opinion and your knowledge of the different factors, the
potential for abuse, the lack of medical use in this country, and the effects of
the drugs?
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Mr.
KING. Administratively, we could not put flunitrazepam into Schedule
I. It would have to be done legislatively. We could not meet all the criteria.
But if I had my druthers, I would put them both in Schedule
I.
Mr. BARR. Okay. Thank you, Mr.
Chairman.
Mr. MCCOLLUM. Thank you, Mr.
Barr.
Just one point of clarification, before we
end, Mr. King. The pharmaceutical companies, in their memoranda to us,—and this
is probably a little unfair because we did not have them here on the panel,
maybe we will have to have them here—have indicated that, whereas technically
there could be some research done on a Schedule I drug, as a practical matter,
it is rare that it is done.
It is difficult
getting grants for it. Money doesn't flow into this. People are scared away from
it, and therefore it diminishes the chance that the research will actually be
accomplished. And they are, therefore, very much opposed to any scheduling of a
drug as Schedule I that might have medical potential, particularly GHB, because
of the potentially good results it may have on
narcolepsy.
Do you have any comment on that? Is
there a gradation here we are missing? I just want to be as honest and open as I
can about the subject and thought I ought to at least lay that on you.
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Mr.
KING. I could research that question and get back to the
committee.
Mr. MCCOLLUM. It would be
very helpful if you would. Because while we are the tough law and order
committee, we have to be fair about. If it really interferes with—I mean
narcolepsy is a pretty serious matter, and if, indeed, GHB is potentially very
useful for that, as I think Dr. Doering indicated and some of the pharmaceutical
concerns have indicated, whatever we do, we don't want to mess up the option
there and miss out on something potentially
beneficial.
Thank you very
much.
[The information referred to
follows:]
| Drug Enforcement Administration, |
| U.S. Department of Justice, |
| Washington, DC, August 31,
1998. |
Mr. DAN BRYANT,
Counsel,
Subcommittee on Crime,
Committee on the
Judiciary,
House of Representatives, Washington,
DC.
DEAR MR. BRYANT: Enclosed are the
responses to the questions on GHB from the July 30 hearing on Controlled
Substances Used to Commit Rape. If you have any questions, please contact me at
the number above.
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Sincerely,
| Ken Ronald, Chief, Congressional
Affairs. |
On
July 30, 1998, the Subcommittee on Crime of the House Judiciary Committee held a
hearing on Controlled Substances Used to Commit Date Rape. During the Question
and Answer session following the testimony of John King, Deputy Assistant
Administrator, Drug Enforcement Administration (DEA), there were two questions
for which Mr. King stated he would provide a detailed response in writing. Both
of these questions concerned gamma hydroxybutyrate
(GHB).
As a preface to our responses, we wish to
state that the Drug Enforcement Administration supports placing GHB in Schedule
I of the Controlled Substances Act (CSA). This action would establish the high
abuse potential of GHB and the public health risks associated with its abuse to
the law enforcement community, the judicial system and the general public. In
addition, such an action would increase the priority given by law enforcement
and the judicial system in combating the trafficking of GHB in the United
States.
1. SHOULD ANALOGUES OF GHB BE COVERED AS SCHEDULE I OR II
SUBSTANCES UNDER H.R. 1530? (QUESTION BY REP. SHEILA JACKSON
LEE)
Yes. However, specific language in the
legislation is not necessary to accomplish this if GHB is controlled as a
Schedule I or II substance under the CSA. In this case, GHB analogues which meet
the definition of a controlled substance analogue (see definition at end of this
response) would be treated as Schedule I controlled substances for purposes of
criminal prosecution. Gamma butyrolactone (GBL), a precursor in the illicit
synthesis of GHB, and 1,4- butanediol, could be considered analogues under the
current CSA definition. However, GBL is our greater concern at the present time.
It should be emphasized that control of GHB in another schedule (i.e., III, IV
or V) would not automatically cover analogues for purposes of criminal
prosecution.
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Gamma
Butyrolactone Problem
The clandestine manufacture
of GHB involves the use of two non-regulated chemicals: (GBL), the primary
precursor as well as an analogue, and sodium hydroxide (lye). GBL is a solvent
with many industrial uses. As an unregulated chemical, GBL is sold in chemical
supply companies and is available for sale over the Internet as a component of a
GHB ''kit''. Several DEA field offices are receiving information on suspicious
GBL orders from chemical supply companies for use as a precursor for
GHB.
In addition, there are reports of the abuse
of and dependence on GBL. These are self-reports from abusers, with no
toxicological evidence, that GBL is being used as a substitute for GHB. Most of
these reports have come from states that have controlled GHB under state laws.
GBL, once absorbed orally, is rapidly converted into GHB in the body and
produces the same profile of behavioral effects as
GHB.
In view of the above, it is clear
that any control action involving GHB must include or be followed by GBL
control. If GHB is placed under the CSA, there are several options for the
control of GBL. If GHB is placed in Schedule I or II, as discussed above, GBL
can be treated as an analogue for purposes of criminal prosecution, if it is
intended for human consumption (i.e., abused for its psychoactive effects). If
GHB is controlled in any schedule, GBL could also be controlled as an immediate
precursor in that same schedule. GBL could also be made a listed chemical. While
GHB remains uncontrolled, we cannot initiate any control action regarding GBL
unless the Department of Health and Human Services (DHHS) provides a scheduling
recommendation specifically for GBL. The level of control of GBL must be weighed
against its current industrial use.
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There
have been a few reports of 1,4-butanediol being abused as a GHB substitute. Its
chemical structure and pharmacology are such that it could be treated as an
analogue and production and distribution for human consumption would be covered
under the analogue provision of the CSA.
Definition of controlled
substance analogue 21 U.S.C. 802(32)
A controlled
substance analogue is defined as a substance which:
(1) has a
chemical structural substantially similar to that of a controlled substance in
Schedules I to II;
(2) has a stimulant, depressant or
hallucinogenic effect on the central nervous system that is substantially
similar to or greater than that of a controlled substance in Schedules I or II;
or
(3) a particular person represents or intends to have a
stimulant, depressant, or hallucinogenic effect substantially similar to or
greater than that of a controlled substance in Schedules I or
II.
The term ''controlled substance analogue''
does not include controlled substances; drugs or substances with approved new
drug applications; substances which have an exemption for investigational use
under the FDA's Federal Food Drug and Cosmetic Act; or substances not intended
for human consumption.
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2.
WHAT IS YOUR COMMENT ON THE PHARMACEUTICAL INDUSTRY'S CLAIM THAT SCHEDULE I
CONTROL OF A SUBSTANCE HINDERS ITS DEVELOPMENT AS A LEGITIMATE PHARMACEUTICAL?
(QUESTION BY CHAIRMAN MCCOLLUM)
Some members of
the pharmaceutical industry have alleged that control of a substance in Schedule
I impedes legitimate research and the development of medications. Certainly,
placing GHB in Schedule I would impose additional regulatory requirements on
those who handle it. These requirements, however, are minimal, particularly for
the researcher, and were determined to be necessary to establish a closed system
of distribution to prevent the diversion of abusable substances, while providing
for the legitimate research and development needs of the pharmaceutical
industry.
The GHB manufacturer would be required
to obtain a Schedule I registration (21 U.S.C. 823(a)), establish adequate
security, obtain quotas if material is manufactured in bulk (21 U.S.C. 826),
maintain records and provide reports (21 U.S.C.
827).
Researchers, including practitioners,
conducting the studies would be required to obtain a Schedule I researcher
registration from DEA (21 U.S.C. 823(f)), keep records of the material obtained
and used, and store the Schedule I substance in a securely locked, substantially
constructed cabinet. In general these requirements are similar to FDA
regulations for research conducted under an Investigational New Drug
Exemption(IND). Individuals applying to conduct research with Schedule I
controlled substances must have their qualifications and competency as well as
their research protocol reviewed for scientific merit by DHHS. The DEA must
determine whether there are effective procedures to safeguard against diversion
of controlled substances from legitimate medical or scientific use. The record
keeping and security requirements for a Schedule I researcher are no different
than those for a researcher with any other controlled substance. Currently,
there are 478 Schedule I researchers registered with DEA and authorized to
conduct research with Schedule I substances.
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Schedule
I controls should not prevent or preclude the development of GHB as a new
pharmaceutical product. There are, for example, other drugs, including
alfentanil, sufentanil, etorphine hydrochloride, difenoxin, LAAM, and dronabinol
(D9-THC) that were in Schedule I while they were undergoing research for
development and eventual marketing in the United States. If a company decides to
submit a New Drug Application (NDA) to the FDA to market a Schedule I controlled
substance, sufficient and appropriate data will be generated to support placing
it in a schedule other than Schedule I. In regard to the substances listed
above, once each was approved for marketing, the DEA expeditiously moved it to a
lower schedule, generally Schedule II. The same process would apply to GHB.
Schedule I control should not prevent any patient population in the United
States from receiving adequate medical treatment. It is important to note that
currently there are 11 states which have controlled GHB in Schedule I of their
Controlled Substances Acts. Schedule I controls at the state level are analogous
to Schedule I controls at the federal level and DEA is not aware of any
impediments to research and development efforts for GHB in these
states.
Ms. JACKSON LEE. Would the
gentleman yield for a moment?
Mr.
MCCOLLUM. Be happy to to yield.
Ms.
JACKSON LEE. Let me first of all thank you very much, and I think
that certainly I made the remark that we must balance the pros and cons. I would
hope that Mr. King, in his answer, and maybe as we proceed for additional
information with hearings that we will have a DEA representative when the
pharmaceuticals are here, but the point being that it is not foreclosed.
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If,
for example, the drug was a Schedule I, it would not be foreclosed from either
further research and/or determined ultimately that it has some valuable use in
being rescheduled. And I think you made that point. I don't want to put words in
your mouth, but I think that is an important point, Mr.
Chairman.
Mr. MCCOLLUM. That was the
point he had made, Ms. Jackson Lee. I wasn't trying to diminish it. I was just
trying to make a point that there is some gradation of gray, apparently, if the
pharmaceutical companies are right, and I was just asking if he knew about
it.
Ms. JACKSON LEE. And I welcomed
his input on that.
Mr. MCCOLLUM. At
any rate, thank you, Mr. King, for being here today. We are going to adjourn
this hearing; we have a vote on. I think everybody has asked their questions.
Thank you so much for being here.
The
subcommittee hearing is adjourned.
[Whereupon, at
3:55 p.m., the subcommittee was adjourned.]
A P P E N D I
X
Material Submitted for the Hearing Record
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Orphan
Medical
Minnetonka, MN
Mr. Chairman and Members of the
Subcommittee:
Thank you for the opportunity to
provide testimony for the record of the Crime Subcommittee's July 30, 1998
hearing on date rape drugs.
Orphan Medical
supports the intent of the hearing. Sexual predators who use GHB to facilitate
their crimes should suffer severe federal
penalties.
Orphan Medical, however, opposes HR
1530's proposal to list GHB as a Schedule I controlled substance. A Schedule I
or Schedule II designation for GHB would have the unintended consequence of
shutting down the promising development of GHB for the treatment of a rare
disease called narcolepsy which incapacitates as many as 180,000
Americans.
GHB is not a narcotic, nor is it
similar to any of the other controlled substances currently designated as a
Schedule I or Schedule II. GHB's appropriate medical use and current evidence of
psychological and physical dependence is comparable to controlled substances
already listed in Schedule IV.
Orphan Medical
proposes that GHB be designated as a Schedule IV substance. This would both
permit the continued development of this drug to treat narcolepsy and provide
harsh federal penalties as defined by the ''Drug-Induced Rape Prevention and
Punishment Act of 1996.'' That act, which was approved by overwhelming
bipartisan support in the House and Senate, provides for up to 20 years
imprisonment for anyone convicted of using a controlled substance to facilitate
a sexual assault—any controlled substance, no matter what schedule it falls
under.
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Additionally,
Orphan Medical proposes that the subcommittee use the ''Drug-Induced Rape
Prevention and Punishment Act of 1996'' as a model to impose Schedule I and II
penalties on anyone convicted of possessing, distributing and manufacturing any
amount of GHB or its analogues.
Many
pharmaceutical companies choose medicines to develop because they are interested
in a certain therapeutic area or see a large market opportunity. Orphan Medical
chooses new medicines to develop in a very different way. As a company dedicated
to patients with uncommon diseases, Orphan Medical develops medicine for
patients whose conditions are so rare there is no other therapeutic
alternative available.
One such condition is
narcolepsy. Narcolepsy patients experience profound sleepiness in the daytime—so
severe that they often find it difficult to drive, hold a job or perform other
seemingly ''normal'' tasks. In addition to excessive daytime sleepiness, some
narcoleptic patients also experience cataplexy, which is a sudden loss of muscle
control which may cause the patient to collapse. Some patients find themselves
virtually unable to function as they may collapse from 25–50 times in one
day.
One promising drug therapy for narcoleptic
patients is gamma hydroxybutyrate (GHB). After the passage of the Orphan Drug
Act of 1983, an Orphan Drug Research Grant was awarded to a scientist who
uncovered scientific evidence that GHB may be an effective and safe medicine for
patients with narcolepsy. Based on this work other scientists became interested,
and along with the National Organization for Rare Disorders (NORD), many
pharmaceutical companies were approached about development of GHB as a treatment
for narcolepsy. Due to the rare nature of this condition and the low revenue
potential all but one company declined. In 1989, NORD and FDA were successful in
convincing Biocraft to commence development of GHB for narcolepsy. However, in
1994 the GHB; development program was abandoned when Biocraft was acquired by a
large pharmaceutical company.
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In
that same year, Orphan Medical was formed as a company dedicated solely to the
development and commercialization of medicines for rare diseases. At the urging
of the FDA's Office of Orphan Products, NORD, and the scientific community,
Orphan Medical commenced development of GHB for narcolepsy with full knowledge
that GHB would be listed as a controlled
substance.
Orphan Medical recommends scheduling
GHB; immediately as a Schedule IV for the following
reasons:
Schedule I and Schedule II are
inappropriate.
Schedule I is reserved for those drugs that have no
current accepted medical use and a high abuse potential; two examples are heroin
and LSD. Schedule II is reserved for drugs that have a high abuse potential, a
serious psychological dependency and a serious physical dependence liability;
two examples are morphine and secobarbital. GHB has a well documented current
medical use and clinical data do not suggest a profile similar to agents in
Schedule I or II.
Schedule I or II would halt the development of
QHB as a narcolmsy treatment.
If GHB; were classified as Schedule I for
the remainder of development, Orphan and its suppliers, would be ''shut down.''
This is evidenced by the fact that only last week, our manufacturer in Illinois
was contacted by the Illinois Department of Professional Regulation and enjoined
from producing further product. This happened, despite the fact that the
Controlled Substance Act (CSA), specifically allows for medical
research. As it stands today, many patients in clinical trials are at risk
of not being able to obtain their much needed medication, due to the actions of
the state.
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A
Schedule II listing would require the additional expenditure of millions of
dollars. That's small change for a big pharmaceutical company; it's commercially
devastating for a tiny company like Orphan
Medical.
Contrary to its intended purpose, the
scheduling of GHB as a II would actually increase the potential points of
diversion. Far more product would have to be manufactured in order to fill a
50,000 pharmacy ''pipeline'' versus what is needed by a small number of
patients. It would be shipped through numerous levels of distribution providing
hundreds, if not thousands, of potential sites for diversion. Schedule IV would
allow for manufacture of the exact amount of drug needed for the patient
population and minimize potential sites of diversion. Direct shipment to the
patient would also permit Orphan Medical to track the use of GHB
patient-by-patient, prescription-by-prescription and to quickly and easily
identify if a patient was attempting to divert the drug. Records would be
available to quickly identify in a proactive manner, patients attempting to
divert drug.
Orphan Medical understands and
agrees with the basic principle that the Scheduling of GHB would be in the
public's best interest and would aid law enforcement's ability to prosecute GHB
abetted crimes to the fullest extent. Orphan Medical believes that legislation
should be amended to accomplish these objectives and we believe it can be done
without jeopardizing this important
medication.
In conclusion, we recommend
consideration of the following actions:
Amend the Controlled Substances
Act to make GHB and its analogues schedule IV.
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Amend
the '96 Date Rape Act to provide stiffer penalties for general possession of any
amount of GHB (precedent has been set with
Rohypnol).
Mr. Chairman and Members of the
Subcommittee, we urge you to consider the recommendations as put
forth.
Sincerely Yours,
| Patti A. Engel, Vice President, |
| Orphan Medical, Inc. |
SCHEDULING
GHB WITHOUT HURTING THE TREATMENT OF AMERICANS WITH NARCOLEPSY
The
key to punishing GHB-aided date rapists under the ''Drug-Induced Rape Prevention
and Punishment Act of 1996'' and imposing the maximurn penalty of 20 years
imprisonment is to list GHB as a controlled substance.
Illegally
manufactured GHB has been implicated in some heinous sexual assaults. The
perpetrators should be put behind bars. However, it is not necessary to list GHB
as a Schedule I substance to ensure appropriate punishment for illegal
use.
Listing GHB as a Schedule III or IV drug would provide
prosecutors with the tools to seek the harshest punishment of the law—up to 20
years unprisonment—under the ''Drug-Induced Rape Prevention and Punishment Act
of 1996.''
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The
Controlled Substances Act may be further amended by imposing the general
penalties of Schedule I and H substances on anyone who illegally possesses,
distributes or manufactures any amount of GHB and its analogues, and by
directing the US Sentencing Commission to appropriately amend the sentencing
guidelines.
Scheduling GHB as a Schedule I or II substance would
have the unintended consequence of halting the clinical development of GHB as a
prescription drug used for the treatment of narcolepsy, a disabling sleep
disorder affecting 180,000 Americans.
GHB used to facilitate sexual
assaults has been cooked up on a stove using legally-obtained materials. It is
not pharmaceutical-grade GHB.
In 1995, FDA and the National
Organization of Rare Disorders patient advocacy group asked Orphan Medical to
undertake the development of GHB as an orphan drug. Orphan Medical is a small
Minneapolis-based developer of drugs used to treat rare
diseases.
Results of FDA-sanctioned clinical trials at 16 sleep
centers were recently submitted to FDA. Narcolepsy patients from California,
Colorado, Florida, Georgia, Kentucky, Maryland, Michigan, Missouri, New York,
Obdo, Oklahoma, South Carolina, Tennessee and Washington
parlacipated.
The clinical trials prove that pharmaceutical-grade
GHB safely and effectively restores natural sleep for people with narcolepsy and
prevents sudden episodes of cataplexy.
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No
other drug therapy provides the therapeutic benefits that GHB has demonstrated
in people with narcolepsy. GHB restores natural sleep, allowing patients to live
a normal life. Absent GHB therapy, they suffer daily episodes of cataplexy? the
sudden and total loss of muscle control.
A New Drug Application for
GHB and its use in the treatment of narcolepsy is expected to be submitted to
FDA as soon as possible.
| Department of Health & Human Services, |
| Office of Orphan Products Development, |
| Food and Drug Administration, |
| Rockville, MD, March 6,
1998. |
BERT SPILKER, Ph.D.,
M.D.,
President, Orphan Medical,
Minnetonka,
MN.
DEAR BERT: In response to your
letter of February 15, 1995, I will be happy to meet with you in my office on
March 23, 1995 at 1:45 PM to discuss general orphan drug development issues. I
understand Dayton T. Reardon, Ph.D., Orphan Medical Regulatory Affairs
Coordinator, will accompany you.
You may feel
free to report that Betaine, Gamma hydroxy butyrate and several other orphan
products are being developed by your firm at the suggestion of FDA's Office of
Orphan Products Development (OPD). You may publicize this information in annual
reports, regulatory documents or at public meetings. I hope this clarification
answers your question.
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I
am looking forward to seeing you and Dr. Reardon on March
23.
Sincerely,
| Marlene E. Haffner, M.D., M.P.H.
Director, |
| Office of Orphan Products
Development. |
| Department of Health & Human Services, |
| Office of Orphan Products Development, |
| Food and Drug Administration, |
| Rockville, MD, March 6,
1998. |
Senator DONALD C. SULLIVAN,
M.D.,
Chairman, Senate Ways and Means Committee,
Florida
Senate Office Building, Tallahassee,
FL.
DEAR SENATOR SULLIVAN: My office
understands that you are interested in some affirmative indication that FDA
continues to support the clinical investigation and development of gainmahydroxy
butyrate (GHB) as a potential treatment for narcolepsy. I can assure you that we
strongly support clinical investigation of GHB for narcolepsy and anticipate
that this drug may have additional legitimate medical uses in other rare
diseases. GHB is designated as an orphan product for narcolepsy under the Orphan
Drug Law which my office administers.
Over nearly
two decades, the Office of Orphan Products Development. along with many patient
groups and their families, has made consistent and persistent efforts to enlist
a sponsor to develop the clinical data on GHB for narcolepsy and obtain FDA
approval for this drug. We are delighted that we now have a committed sponsor;
we continue to give full clinical evaluation to this therapy as very high
priority.
Page 124 PREV PAGE TOP OF DOC
FDA
supported some early GHB research with its grant funds. As physicians, we know
narcolepsy is a serious condition for tens of thousands of patients who have no
adequate treatment today. And as physicians, we know that substances like GHB
may have potential for abuse and harm. FDA has and continues to support strong
penalties for those who abuse GHB for non-medical
uses.
Please call upon me if I can be of any
further assistance.
Sincerely,
| Marlene E. Haffner, M.D., M.P.H. |
| Rear Admiral, United States Public Health
Service, |
| Director, Office of Orphan Products
Development. |
Members
of the Subcommittee:
I appreciate the opportunity
to provide testimony for the Subcommittee's July 30th hearing on H.R. 1530, the
Hillory J. Farias Date Rape Prevention Drug Act, which is designed to ban drug
substances that have been used for ''date rape'' purposes. The Subcommittee is
addressing the issue of designating GHB and other substances Schedule One;
effectively banning the drug for any purpose. The banning of GHB would be
a HUGE mistake.
I have a chronic disease
called Narcolepsy. Although it is uncommon, approximately 150,000 people in the
U.S. suffer from this disorder. Along with the more commonly known symptom of
overwhelming fatigue, another symptom of Narcolepsy is Cataplexy. Cataplexy is
the sudden and complete loss of muscle control usually triggered by emotion. The
cataplexy leaves one unable to move or talk for as little as a few seconds up to
30 minutes or more with each episode. A person may go days between attacks or
may have many (30–50+) episodes in a day. I have the more serious degree of
symptoms. Currently, the only available treatments for cataplexy consist of
effectively removing all emotions. I have been on various anti-depressants for
over ten years. The anti-depressants have enabled me to function, have a job,
and care for my daughter.
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For
the last fifteen months I have been fortunate to be involved in a medical study
by Orphan Medical investigating new treatments for Cataplexy. The new substance
that I have been taking through the medical study is WONDERFUL! Not only have my
cataplexy attacks been greatly controlled, but I am much less tired. All this
AND I have my feelings back. I can feel joy as I listen to my daughter excitedly
tell me a story about her life. I can feel touched by a sad story. I can simply
feel again. The substance that I have been taking that has really
improved the qualify of my life is GHB.
We've
all heard the cliché ''get a life''. I feel like I have gotten a chance to have
a life. One where I don't need to be afraid that I will fall and hurt myself or
simply make someone else uncomfortable or afraid. Although compared to a
''normal'' person I am still very, very tired, relatively I feel better than I
have felt for over ten years. I'm almost afraid to say it . . . I feel
good.
The hearing on Thursday, July 30th
addressed making GHB a Schedule One substance. This would effectively ban the
drug for any purpose. The drug trial I have been involved in would be stopped
and, sadly, the first help for Narcolepsy patients would be shelved. PLEASE DO
NOT DO THIS! GHB has made a tremendous improvement in my life. Narcolepsy is so
misunderstood. The other Narcolepsy patients I have met through the years have
had sad, lonely lives. Please help! I couldn't bear to go back to the treatment
regime I had been sentenced to before.
If GHB is
made a Schedule One substance, no patient could ever get this life-saving drug.
While this might seem to be the only answer to prevent the terrible use of GHB
in date rape, it is not the only answer. GHB could be scheduled as a Schedule
Four drug. Its distribution would be highly controlled, but it would still be
available to the very sick patients who need it. If the Subcommittee believes
something is needed, please do not ''help'' some people while terribly hurting
others.
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As
a female and single mother of a young teen daughter, I know that banning GHB
will not stop victimization of women. People will find other substances, or ways
of making current substances whether banned or not. Nice boys don't decide to
rape girls with the aid of drugs because there is a prescription use for those
drugs. I would guess that a ban of GHB will not prevent a single rape. BUT THE
BAN OF GHB WILL AFFECT THE LIVES OF MANY NARCOLEPSY PATIENTS WHO CAN FINALLY
HAVE A BETTER TREATMENT FOR A QUIET, DISABLING
DISEASE.
Thank you for your time and
attention.
| Mali A. Einen,
einen@msn.com |
| National Organization for Rare Disorders, Inc., |
| New Fairfield, CT. |
Mr. Chairman
and Members of the Subcommittee:
My name is Abbey
Meyers. I am President of the National Organization for Rare Disorders (NORD),
an organization formed fifteen years ago to represent patients and families of
patients with rare disorders often called ''orphan'' diseases. Today, NORD
represents over 5,000 rare diseases affecting an estimated twenty million
Americans. For the vast majority of these people, there is no effective therapy
or treatment for their conditions. Many of these conditions are life-threatening
and disabling; all of them are life-altering and accompanied by terrible costs
in physical and emotional suffering as well as frequently frustrating and
ineffective health care.
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NORD
appreciates the opportunity to provide testimony for the subcommittee's hearing
on potential legislation that would result in scheduling, as a Schedule I
controlled substance, the drug product gamma-hydroxy butyrate (GHB), which is
currently being developed as a treatment for the most debilitating symptom of
narcolepsy. We are interested in this issue because of our belief that such
legislation, if enacted, would halt the development of this critically important
drug, prevent its marketing as an FDA-approved safe and effective therapy, and
deprive thousands of desperately ill people of the best chance they have of
living normal lives while afflicted with the mysterious and as yet incurable
illness, narcolepsy.
NORD began its work to help
people with orphan diseases by uniting patient organizations, medical
professionals, patients and families together in an effort to encourage Congress
to pass, and President Reagan to sign into law, the Orphan Drug Act of
1983. That Act provides financial incentives to entice pharmaceutical
companies into conducting research and development needed to produce safe and
effective medicines for small populations of patients. Because of the small
potential markets for these drugs, there was little potential for profit and
therefore pharmaceutical companies did not want to manufacture
them.
There were fewer than ten orphan drugs
developed during the decade before 1983. Now there are more than 850 designated
orphan drugs and 170 of them have been approved by the FDA for marketing in the
United States. But we still have a long way to go. It is a huge challenge for us
to reach the ultimate goal of providing hope for patients and families facing
the tragedy of a little known incurable disease; an anguish made worse because
the disease is rare and thus is much less likely to draw the interest and
attention of researchers and companies who might develop a therapy. That
challenge is only manageable if we believe we can reach our goal one drug and
one disease at a time; we cannot ever hope to meet the challenge if truly
insurmountable obstacles fall into the path of drug developers.
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We
have been advocating for commercial development of GHB for more than fifteen
years. Indeed, the federal government recognized the significance of GHB during
the 1980's when it awarded an Orphan Drug Research Grant to a narcolepsy
scientist who launched a clinical trial showing it is a safe and effective
therapy. Based on the success of that trial, we begged pharmaceutical companies
to develop the drug, particularly because the only current therapies for
narcolepsy are amphetamines, which are habit-forming controlled substances.
Becauseihe government rations the annual manufacturing of amphetamines, there
are often shortages of these drugs during which narcolepsy patients are left
with no treatmentatall. One can only imagine how difficult it must be to hold a
job or drive a car when you cannot stop yourself from falling asleep. It is as
serious as suffering from epileptic seizures.
We
truly believe that scheduling GHB as a Schedule I or II controlled substance
would be an insurmountable obstacle for a small drug manufacturer and a
nightmare for patients and doctors. The is that the security, registration,
reporting, and other requirements a company would have to meet to manufacture
the drug, or even to continue ongoing research on it, would be so costly as to
make the investment prohibitive. Keep in mind that the patient population for
this drug is extremely small—it will be prescribed primarily for a subset of
narcolepsy—those who suffer from cataplexy. (They can literally become
unconscious and fall to the floor triggered by an emotional reaction such as
laughter, excitement, or anger, and they become paralyzed during sleep, as if in
a coma.) This means the market for the drug is very limited, and the ability of
a company even to earn a return on its research investment is extraordinarily
limited. Moreover, such restrictions would make the cost of the drug
unaffordable to many narcolepsy patients, and it would encourage doctors not to
prescribe it.
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There
are only a few companies willing to commit to manufacturing a product with such
a small possibility of profit. FDA's Office of Orphan Products Development
expends enormous effort to find and work with companies that might do this kind
of work, when that office believes there is a real possibility for helping
patients with an orphan disease. That was the case for
GHB.
FDA recognized that GHB offered a real
medical advancement for narcolepsy patient with severely disabling cataplexy
symptoms. It funded the first American clinical trial of the drug through an
Orphan Drug Research Grant. They also recognized the abuse potential of this
chemical and took steps to prevent its being sold over-the-counter in health
food stores. But this left only one option for patients: get an approved
prescription version of GHB on the market as soon as possible. FDA sought out
and found one company willing to do the studies necessary for FDA approval:
Orphan Medical in Minnesota is a small company dedicated solely devoted to
development of orphan drugs. If action were taken now that would stop or impede
this progress, the consequences would be disastrous for people with narcolepsy.
First and most tragic, if this company does not complete its development of the
drug, or does not accomplish the costly and difficult manufacturing
requirements, narcolepsy patients will never have access to this
treatment.
There is also another consequence that
is equally troubling. That is other companies will watch this disaster and learn
that even if FDA ''recruits'' them to develop an orphan drug, and even if they
are well along in the development process, their investment or resources may be
at risk. If one arm of the government encourages you to develop the product,
while another discourages you without regard to the valid medical need for the
product, this could be disastrous for the future of all orphan drug
development.
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Some
might ask: ''Why is this a problem? If a company can develop one product to
treat a disease, it can develop another. There are so many possibilities for new
drugs. It just isn't possible that there is only one compound that works.'' I
want to assure the members of this Subcommittee that, for orphan diseases,
nothing could be further from the truth. The reality for patients with orphan
diseases is that if there is one possible therapy, it is almost
miraculous. To think they have a choice, or that companies are out there
competing to put a variety of products on the market for narcolepsy, is simply
unrealistic. In short, for patients with sever and debilitating narcolepsy, GHB
is their only hope for a non-habit forming treatment. Making GHB a Schedule I
controlled substance destroys that hope.
But that
does not mean that we believe this drug should be on the market without control
of any kind. We know, as you do, that this chemical has been used illegally and
is being abused, and this should be prevented. We agree that the strongest
possible penalty should be in place for those who commit crime utilizing this
drug, or for those who possess this drug with no other reason than to use it
improperly and illegally. However, just as Congress has not made guns illegal
simply because some people commit crimes with guns, neither should the
government prevent very ill people from having access to a drug that has a valid
medical use only because some criminals might abuse
it.
We urge the Subcommittee and the Congress to
work with the DEA to ensure that proper controls are placed on the distribution
of GHB and that those who abuse the drug receive the strongest penalties. But
this can be done without placing the drug under Schedule I. Placing
GHB under Schedule III or IV, but providing the authority to the Department of
Justice to levy the maximum penalty for abusing the drug, strikes the right
balance. It gives law enforcement officers the ability both to deter and to
punish wrongdoers, but it does so without penalizing patient who need access to
a proven safe and effective medication they desperately need.
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The
first and most important step that Congress can take is to regulate the Internet
and get the formula for GHB off of the World Wide Web! None of the crimes
involving GHB have been caused by the medical version of the drug. They have all
been caused by criminal amateurs who make the compound themselves. To make GHB a
Schedule I drug would be tantamount to scheduling Aspirin as Schedule I simply
because some people (7,000 per year) die from
Aspirin.
We stand ready to provide the
Subcommittee with any additional information you may need regarding orphan
diseases, the Orphan Drug Act, or the importance of GHB for patients with
narcolepsy. We urge you not to take an action which, while it may seem to help
some people, will certainly harm others. Thank you for the opportunity to
present our views.
| National Sleep Foundation, |
| Washington, DC, August 10,
1998. |
Hon. BILL MCCOLLUM,
Chairman,
Subcommittee on Crime,
Committee on the
Judiciary,
House of Representatives, Washington,
DC.
DEAR CHAIRMAN MCCOLLUM: I am
writing on behalf of the National Sleep Foundation (NSF) regarding H.R. 1530,
the ''Hillory J. Farias Date Rape Prevention Drug Act'' which was recently
discussed at hearings before the Subcommittee on Crime. This legislation is of
great concern to the National Sleep Foundation because it would place Gamma
hydroxybutyrate (GHB) in Schedule I of the Controlled Substances Act and greatly
hinder research and clinical trials currently being conducted by a small drug
company and sleep disorders clinics for the treatment of narcolepsy.
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The
National Sleep Foundation is a nonprofit organization, founded in 1990,
dedicated to promoting public understanding of sleep and sleep disorders through
education, research and advocacy initiatives in order to improve pubic health,
safety and productivity. Our board of directors consists of some the nation's
top sleep experts who have years of research and clinical experience in the
treatment of sleep disorders including
narcolepsy.
Narcolepsy is a chronic neurological
disorder that affects the central nervous system and causes excessive daytime
sleepiness, cataplexy, sleep paralysis, and hypnagogic hallucinations. This rare
genetic disorder affects approximately 250,000 people in the United States, most
of whom are undiagnosed due to the lack of awareness of primary care physicians.
It is estimated that about 30,000 people with narcolepsy suffer some form of
cataplexy (the sudden loss of muscle control ranging from slight weakness to
total collapse). The usual age of onset is during the late teens or early
twenties when young people are attending high school, college or beginning
employment that will shape the rest of their lives. People with narcolepsy
suffer from irresistible sleep attacks throughout the day, during business
meetings, social events, during conversations, and while driving. The disorder
causes enormous disruptions in patient's lives that can become debilitating if
not carefully managed and treated.
Because little
is known about narcolepsy by the general public and most primary care
physicians, the average person with narcolepsy sees at least five doctors and
suffers for some 15 years before they are properly diagnosed. At this time,
there is no cure for narcolepsy and treatment options are limited. Medications
are the only treatments available to minimize the affects of this disorder.
Excessive daytime sleepiness related to narcolepsy is treated with stimulants
while cataplexy is treated with antidepressant medications. Unfortunately,
medications only reduce symptoms of narcolepsy, they do not alleviate them all
together. All drugs currently available for narcoleptics were developed for
other disorders.
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While
Narcolepsy is just one of eighty sleep disorders, the NSF has recognized the
severe effects the disorder has on people, especially young adults, and has
taken actions to promote research and treatment regiments. In September of 1996,
the NSF founded the National Narcolepsy Registry (NNR) which is housed at the
Montefiore Medical Center in the Bronx, New York. The NNR was developed to
provide a major resource for researchers who wish to study the cause of
narcolepsy. The Registry has been overwhelmingly supported by patients and
patient support groups such as the Narcolepsy Network. The NNR is the primary
source of genetic material for a new fouryear study being funded by the National
Institutes of Health that will help identify the genes responsible for the
disorder. The NSF is committed to finding effective and safe treatments for
narcolepsy, its related symptoms and eventually a
cure.
Due to the effect H.R. 1530 would have on
the development of GHB, the NSF cannot support moving this promising treatment
to Schedule I status. As you may know, several organizations, including the Food
and Drug Administration's (FDA) Office of Orphan Products Development and the
National Organization for Rare Disorders, Inc., underwent a lengthy search to
find a company to further investigate GHB for the treatment of narcolepsy. It
appears that no drug companies other than Orphan Medical showed any interest in
GHB because narcolepsy remains a relatively rare disorder. Orphan Medical
specializes in developing drugs that other companies will not manufacture due to
the low profit potential. The development of GHB for narcolepsy has been
enthusiastically supported by the FDA over the
years.
Because Orphan Medical remains a
relatively small company, the NSF is concerned that listing GHB as a Schedule I
substance would place an undue burden on the company and possibly hinder further
development. Additionally, we are told that the labs currently taking part in
clinical trials would be faced with increased administrative and security
concerns that would be extremely time consuming and costly; placing their
research in jeopardy. The NSF is encouraged by the primary data and anecdotal
evidence provided by patients and physicians associated with clinical trials
using GHB.
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One
point that was made very clear by the Drug Enforcement Administration and
representatives from the Orlando police department during testimony before your
Subcommittee was that the GHB being sold at clubs and over the Internet is not
coming from drug companies or medical labs, but almost entirely from
''clandestine laboratories.'' Therefore, it seems that enforcement measures
should be aimed at the sources which allow people to illegally manufacture GHB
at home rather than drug companies that are manufacturing it for legitimate
medical research and clinical trials. If the dealers are as young as law
enforcement officers say, will they really be paying attention to whether GHB is
a scheduled drug or not? If so, will it really make a difference to these
criminals whether GHB is a Schedule I drug rather than a Schedule
IV?
The National Sleep Foundation believes that
there are strong measures (some of which were already mentioned by members of
the Subcommittee) that can be taken to see that police officers have the
necessary tools to get GHB off the streets without affecting people who suffer
from narcolepsy. The NSF supports the
following:
1. Placing GHB in Schedule III or IV
of the Controlled Substances Act. This would properly place GHB under the
jurisdiction of the Drug Enforcement Administration without adding unnecessary
burdens on Orphan Medical, drug manufacturers who contract with Orphan, and the
16 clinical labs currently conducting trials. While placing GHB in Schedule I
would not legally prohibit Orphan from continuing its research and development
of this compound, it would, in effect, create large financial and administrative
barriers that would put further research in real
jeopardy.
2. Amend the ''Date-Induced Rape
Prevention and Prevention Act of 1996'' to add criminal sanctions for the
illegal possession or distribution of GHB similar to those currently in place
for Rohypnol. As you suggested during the hearing, this would place the most
severe criminal sanctions on those people caught manufacturing, possessing or
distributing GHB—treating GHB as a Schedule I drug while actually listing it as
a Schedule III or IV. The NSF believes that this measure would give law
enforcement officials what they need to stop the flow of homemade GHB while not
affecting the promising research that is currently taking place for the
treatment of narcolepsy.
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3.
Add GBL, a major component needed to make GHB, as a ''listed drug.'' As we
understand it, this would place significant hardship on the operations which
currently sell GBL to people who make GHB themselves or sell ''GHB Kits'' over
the Internet. This would make it more difficult for people to import GBL from
Mexico which accounts for much of the GHB production. It would also put stricter
sanctions on the people directly responsible for the abuse of illegal GHB
production rather than medical professionals seeking legitimate
treatments.
Additionally, the NSF asks that Crime
Subcommittee hold additional hearings to hear from narcolepsy patients, sleep
experts conducting the trials, representatives of Orphan Medical, and the Food
and Drug Administration's Office of Orphan, Product Development before it moves
forward with any legislation affecting legitimate GHB production. The National
Sleep Foundation strongly believes that the measures proposed in H.R. 1530 will
do little to stop the illicit manufacture, sale and abuse of GHB while hindering
further development of it for legitimate medical
purposes.
Unfortunately, people and organizations
in the health community are constantly faced with the realties of the market
economy when looking to conduct research or develop new drugs or treatments. An
overwhelming factor in seeking new drugs for relatively obscure disorders or
diseases is whether a drug company will be able to allocate sufficient resources
to properly develop and test a drug that will provide an economic return. Simply
put, the bottom line is if a company cannot reasonably profit from the enormous
effort they put in to the development of a new drug, they will not manufacture
it leaving a potentially life-saving alternative out of the reach of those who
desperately need it. We hope that you and the Crime Subcommittee will help us
find alternative solutions to those put forth in H.R. 1530 and see that
criminals are dealt with severely and that people suffering from narcolepsy are
provided the best treatment available as quickly as possible.
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Thank
you for your time and consideration.
Sincerely,
| William Dement, M.D., Ph.D., Director, |
| Stanford University Sleep Disorders Clinic |
| Government Affairs Committee Chair, |
| National Sleep
Foundation |