The Cognitive Enhancement Research Institute

[Image]Editorial
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                                GHB Madness

                 by Ward Dean, M.D., and Steven Wm. Fowkes

Gamma-hydroxybutyric acid (GHB) is a natural substance found in many
foods,
and is both a precursor and metabolite of the amino acid GABA (see SDN
v4n7p4). One might think, given its nutrient derivation, that GHB
would be
accepted as just another cooking.net">food supplement in the over-the-counter
health
cooking.net">food market. While that may once have been the case, it certainly
isn't the
way GHB is currently perceived by the FDA.

Prior to 1994, the FDA had the power to arbitrarily classify almost
anything as a drug. The FDA's definition of a drug included 1)non-food
items "intended to affect the structure or function of the body of man
or
other animals," and 2)items intended to "treat, cure, mitigate or
prevent"
disease. The category of "food supplements" did not then exist. In the
eyes
of the FDA, cooking.net">food supplements could be classified in many different
ways: as
{*filter*}, cooking.net">food additives, or even {*filter*}erants. By their ridiculously
broad
definition, almost anything and everything could be considered a drug,
including water, exercise, sports equipment, classical music, or
sunlight--all of which can either affect the structure or function of
the
body, or treat or prevent disease.

Although these arbitrary and capricious powers of the FDA to label
nutritional supplements as cooking.net">food preservatives and {*filter*}erants were
repeatedly ruled improper and illegal in a number of court decisions,
the
agency failed to restrain its actions. Finally, attempts to rein in
this
rogue Federal agency culminated in the passage of the Dietary
Supplement
Health & Education Act of 1994 (DSH&EA), wherein those powers were
severely
restricted. With the passage of DSH&EA, the FDA was absolutely
prohibited
from classifying nutrients as cooking.net">food preservatives or {*filter*}erants.
Furthermore, they were permitted to remove cooking.net">food supplements from the
market
only if there was a threat to public health involved. Any such
removals
would require convening a set of public hearings to review the
decision, at
which public input would be accepted, all testimony would be open, and
the
proceedings would be published in the Federal Register. Never before
had
the internal decision-making process of the FDA been exposed to public
scrutiny. Significantly, the FDA has so far avoided any decisions that
would require such exposure.

In November, 1990, 4 years prior to the DSH&EA, the FDA issued a
national
press release announcing that GHB was a drug. Instead of following
formal
regulatory procedures for assigning a status to GHB, the FDA took the
unusual (and legally unsanctioned) step of announcing their decision
in a
press release! That's all--a press release! Based on this press
release,
agents of the FDA started investigating, arresting and prosecuting
many
health cooking.net">food store owners and distributors for selling an "unapproved
new
drug" (i.e., GHB). Some people were promised lenient treatment if they
would testify against others (the "big fish"). Some of these people
went to
prison, and are now branded as "convicted felons"--unable to vote, own
firearms, or enjoy many of the other rights of free citizens. We will
probably never know what process was followed in this decision.
However,
the FDA's disdain for following even their own rules and regulations
had
become routine operating procedure.

At a recent court case at which I [WD] testified as an expert witness
regarding the safety of GHB, it became evident that the government
representatives in this case (prosecutors, FDA agents and FDA expert
witnesses) either didn't know what they were talking about regarding
GHB
(which I have a hard time believing) or were deliberately lying (the
only
reasonable alternative).

In previous, similar GHB cases, the prosecution (the Justice
Department)
attempted to portray GHB as a Schedule I controlled substance (a drug
that
has no medical uses, with a strong potential for {*filter*}ion and
abuse--like
{*filter*}). Federal prosecutors withheld knowledge from the defense of
the
existence of a number of Investigational New Drug Applications (INDs)
for
GHB on the rationale thatthey "contained no relevant information."
Years
later, after a number of people had spent considerable time in prison,
higher courts ruled against the withholding of these INDs, overturned
many
of the GHB convictions, and forced the FDA to submit copies of all
INDs to
the courts for inclusion in still-pending trials, or re-trial of
overturned
cases.

The GHB INDs were telling. Instead of corroborating the FDA's views
and the
testimony of government expert witnesses, the INDs flatly contradicted
them. GHB was repeatedly described, in IND after IND, as a safe,
non-toxic,
non-{*filter*}ive substance, with an extremely wide margin of safety. With
the
INDs in evidence, the prosecution is having a hard time convincing
either
judge or jury of the dangers of GHB. With the growing realization that
GHB
was never properly classified as a drug, and that it now fits the
Federal
legal definition of a cooking.net">food supplement, the judicial system is
recognizing
that it has been "had" by the FDA. One of the FDA's expert witnesses
who
recently testified as to the dangers of GHB was forced to admit that
she
had never seen a single patient who had taken GHB.

As the FDA's GHB convictions are unraveling at the seams--with at
least one
US government attorney in jeopardy of being disbarred because of
prosecutorial misconduct in these GHB cases--the FDA has adopted
several,
new, "end-run" tactics. They have shifted emphasis in the anti-GHB
crusade
from the courts to the media. FDA, DEA and police agents are telling
reporters that GHB is a dangerous, lethal and {*filter*}ive drug; that it
is an
illegal "designer" drug; and that it is a "date{*filter*}" drug. Such
"expert"
opinions have propagated a plethora of hysterical articles in the
popular
(and even medical) press to demonize GHB. Frenzied media reports about
River Phoenix, dead {*filter*}agers, and near-death experiences of GHB-using
club-goers are sweeping the nation.

We have found, however, in the process of investigating every alleged
GHB-related death, that none can be legitimately attributed to any
purported toxic effect of GHB. Furthermore, in almost every case in
which
GHB was declared as a cause of death, I [WD] found that the medical
examiner had been influenced in his decision by a "helpful" agent from
the
FDA or DEA, who had "kindly" explained the dangerous toxicity of GHB.
In
many cases, allegations of GHB use were simply not true (e.g., River
Phoenix's death). In all others, in which GHB use was confirmed, the
cause
of death was due to other factors or other diseases. The Chief Medical
Examiner of San Francisco County-- who developed the most widely used
technique for identifying and quantifying GHB levels in body fluids
and
tissues, and whose laboratory is frequently used by the FDA and DEA to
test
samples--told me [WD] that he had never seen a death due to GHB
toxicity.
He explained what he believed to be the true cause of death in every
case.

The strategy begind the anti-GHB media campaign is tough new laws to
criminalize GHB sales and posession. Attempts are now underway in
several
state capitols to ram new anti-GHB bills through state legislatures
before
"any more kids will die from the evil GHB." Georgia, Rhode Island,
Florida,
California and Hawaii are states that have introduced or are
considering
such bills. Who knows which other states will follow suit shortly.

In California, Assembly Bill 6 (AB6) specifies that GHB will become
classified as a Schedule I drug (that "would only be lawfully
available for
research and would have no approved medical use"). No medical uses?
That's
right, no medical uses! Although GHB is currently recommended and/or
prescribed by doctors for a host of applications (lowering muscle
tension,
enhancing relaxation, relieving anxiety, inducing natural sleep,
aleviating
depression, assisting marital sex problems, etc.), no medical uses
will be
allowed.

Apparently, none of these state Legislators have been informed that
there
are 15 INDs filed with the FDA for 1)improving sleep patterns and
maintaining daytime alertness in narcolepsy, 2)reducing schizophrenic
symptoms, 3)stabilizing Parkinson's disease, 4)reducing nocturnal
myoclonus
(painful leg cramps at night), 5)improving memory problems,
6)stimulating
natural growth hormone release, 7)decreasing pain and improving sleep
in
fibromyalgia, 8) relieving symptoms in Huntington's chorea,
9)regulating
muscle tone in dystonia musculorum deformans, 10) controling tardive
dyskinesia symptoms, 11)decreasing drug withdrawal symptoms ({*filter*}
and
opiates), 12)decreasing hyperactivity and learning disabilities in
children, 13)inducing sedation and tranquilization, 14)relieving
anxiety
[in fact, it has been recommended as the anti-anxiety agent of choice
for
potentially suicidal patients], and 15)lowering cholesterol. No
medical
applications, indeed.

The incredible dichotomy between GHB as a safe miracle nutrient (with
extensive applications to a host of human maladies) and GHB as a
lethal
designer drug (used for date{*filter*} and other nefarious purposes) can
hardly
be more striking. What or who is behind this "reefer madness" of the
90s?

The lack of danger and minimal {*filter*}ive risks of GHB are graphically
illustrated by the FDA-approved protocols for dispensing GHB in
narcolepsy
studies. After preliminary laboratory-monitored sleep studies (one or
two
nights to obtain a baseline), the test subjects are given large
containers
of GHB, told what dose range to take (6-8 grams per night), and
instructed
to come back for more GHB when they need it.

The protocol also instructs the subjects go to bed immediately after
taking
the GHB, and remain in bed for 6-8 hours until morning. However,
considering the number of elderly subjects in the studies, with their
known
propensity to visit the bathroom several times each night, it is
doubtful
that these instructions are rigidly followed. Were there any adverse
effects? In one of the multi-year studies, which employed nearly 75
people,
it appeared that there was about a 20% incidence of bed-wetting--the
most
disturbing side effect. However, when the data were analyzed, it was
found
that all the bed-wetting was experienced by one 84-year-old patient,
who
said that he'd rather continue to wet the bed and get a good night's
sleep
than stop taking GHB! Other side effects that were occasionally
reported
included sleep-walking and various minor incidences of nausea and
vomiting
(which were dose-related, and usually resolved with continued use).
Included in these INDs were reports of many people taking as much as
30
grams of GHB per day for several months without ill effects.

This is hardly a picture of danger and {*filter*}ion. This is hardly
"irrelevant" to court cases in which government expert witnesses are
testifying about GHB's toxicities, dangers and {*filter*}ive properties.
And
this is hardly a situation requiring criminalization. This is a crisis
manufactured by the FDA, aided and abetted by the DEA, compounded by
local
police, inflamed by the media, and perpetuated by ignorance. We do not
need
to have "GHB madness" become a permanent part of our culture as law.
We do
not need to disenfranchise patients, impair the practice of medicine,
and
drive citizens to obtain their cooking.net">food supplements in the drug
underground.

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Bios:

Dr. Ward Dean is a graduate of the U.S. Military Academy at West
Point, a
recently retired Navy Commander, and the former flight surgeon for the
anti-terrorist Delta Force. He is currently the Medical Director of
the
Center for Bio-Gerontology in Pensacola, Florida.

Steven Fowkes is currently the Executive Director of the Cognitive
Enhancement Research Institute in Menlo Park, California. He is an
organic
chemist.

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GHB Report to the California Legislature

by Steven Wm. Fowkes
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What is GHB?

GHB (gamma-hydroxybutyric acid) is a natural metabolite of human
metabolism. It is a carbohydrate, found extensively throughout the
human
diet (all animal-flesh foods contain GHB). GHB is biologically
synthesized
from gamma-aminobutyric acid (GABA), a structurally similar amino acid
that
is also widespread in human metabolism and diet. GHB is also
biologically
converted back into GABA.

GHB was first synthesized in 1961 by Dr. H. Laborit, a French
researcher.
In the brain, the highest amounts are found in the hypothalamus and
basal
ganglia [Gallimberti, 1989]. Dr. Laborit found that GHB exhibited a
range
of effects beyond those expected from GABA (which is established as a
basic
inhibitory neurotransmitter). GHB has come to be used in Europe as a
general anesthetic, a treatment for insomnia (sleeplessness) and
narcolepsy
(a daytime sleeping disorder), an aid to childbirth (it enhances
cervical
dilation), a treatment for {*filter*}ism and {*filter*} withdrawal syndrome,
an
anti-anxiety and anti-stress agent, and for many other uses. GHB is
currently available by prescription in the US through compounding
pharmacies. It has no formal drug status with the FDA (although 15
INDs are
pending).

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What is the legal status of GHB?

Federal law (the Food, Drug & Cosmetics Act) now classifies GHB as a
cooking.net">food
and dietary supplement.

Prior to 1994, GHB could be classified as a cooking.net">food and/or a drug. The
Dietary
Supplement Health & Education Act of 1994 created a new category of
"dietary supplement," items of which, according to law, were to be
regulated as foods. This category was defined to include: 1) vitamins,
2)
minerals, 3) amino acids, 4) nutrients, and 5) herbs, and extracts,
concentrates and metabolites of all of the above. Since GHB is 1) a
nutrient and 2) a metabolite of the amino acid GABA, it meets two
separate
legal qualifications for status as a dietary supplement.

The dietary supplement status of GHB is of no influence on whether the
FDA
does or does not approve GHB as a drug. And according to the new law,
approval of GHB as a drug would not affect its status as a dietary
supplement. The only way for the FDA to revoke GHB's status as a
dietary
supplement is 1) to establish, in an open rulemaking procedure, that
it
poses an unacceptable risk to public health, or 2) to declare that it
is an
imminent risk to public health, which must be subsequently confirmed
in an
open rulemaking procedure. Why is the FDA avoiding this approach?

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Is GHB a Drug?

The category of dietary supplement specifically excludes items already
classified as {*filter*} prior to 1994. However, GHB was never classified
as a
drug by the FDA. The FDA did declare GHB to be a drug in press
releases,
media interviews, and expert-witness court testimony prior to 1994.
However, these declarations have no force of law. They do not not meet
regulatory requirements for formal action by the agency.

GHB is not the only dietary supplement to be so treated by the FDA. On
countless occasions, the FDA has attempted to declare that vitamins,
herbs,
amino acids and other nutrients were {*filter*}. The FDA has also declared
that
dietary supplements were cooking.net">food additives and {*filter*}erants. Such actions
have
been declared illegal and improper by numerous courts, and all of
these
were severely restricted or directly forbidden by law in 1994.

The loss of the FDA's power to declare nutrients to be {*filter*} may be
one of
the reasons they are trying to influence the courts, the DEA, local
coroners, media reporters and state legislatures to criminalize GHB.

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GHB's Day(s) in Court

The FDA's national press release of 8 November 1990, which declared
that
GHB was a drug, marked the beginning of a series of law-enforcement
actions
and court cases. At that time, GHB was being sold in health cooking.net">food
stores on
an over-the-counter basis. With that press release, the FDA and
federal and
local police began to threaten businesses with legal prosecution for
selling GHB. They arrested business owners and told them that they
would be
prosecuted unless they testified against their wholesale suppliers.

The FDA succeeded in driving the GHB business underground. They began
legal
proceedings against GHB distributors and manufacturers. They charged
them
with labeling and drug violations. The FDA provided expert witnesses
who
testified as to the serious dangers of GHB. During the trials, the
Federal
prosecutor and FDA blocked the court's and defense's access to GHB
INDs
which were represented to "contain no relevant information." The GHB
distributors and manufacturers were convicted and sent to prison.

When this issue was reviewed in Federal District Court on appeal, this
decision was overruled and the lower courts were instructed to admit
the
INDs. There were 15 INDs. All of them flatly contradicted the FDA's
expert
witnesses. The universal opinion of the INDs was that GHB was
non-toxic and
non-{*filter*}ive, and had an extremely wide margin of safety. This
opinion was
amply supported by the FDA-approved GHB-dispensing protocol within the
decade-long narcolepsy studies. The study subjects received a large
container of bulk GHB, told what dose to take, and instructed to come
back
for more when they needed it. There were no problems whatsoever with
this
protocol. There were no {*filter*}ion problems. There was no toxicity.

I was present in the San Francisco courtroom when the {*filter*}arguments
for
appeal were presented. Charges of prosecutorial misconduct were openly
discussed by the three-member panel of judges relating to several
actions
of the prosecutor. Falsifying the impartial analysis of the INDs was
only
one charge. There were also charges of repeated prejudicial comments
to the
jury about the defendant's failure to testify indicating his guilt,
and
several unprofessional personal attacks on the defense counsel in
front of
the jury. The judges suggested referring the matter for disbarment
proceedings.

The government's cases against the GHB defendants are unraveling at
the
seams. In hindsight, we can now see that the convictions were obtained
by
sacrificing justice in the interest of the FDA's politically motivated
policy towards GHB. They couldn't convict on the real evidence, so
they
falsified evidence through expert witnesses and withheld evidence by
blocking the INDs.

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What's in the INDs?

There are 15 INDs filed with the FDA for 1) improving sleep patterns
and
maintaining daytime alertness in narcolepsy, 2) reducing schizophrenic
symptoms, 3) stabilizing Parkinson's disease, 4) reducing nocturnal
myoclonus (painful leg cramps at night), 5) improving memory problems,
6)
stimulating natural growth hormone release, 7) decreasing pain and
improving sleep in fibromyalgia, 8) relieving symptoms in Huntington's
chorea, 9) regulating muscle tone in dystonia musculorum deformans,
10)
controlling tardive dyskinesia symptoms, 11) decreasing drug
withdrawal
symptoms ({*filter*} and opiates), 12) decreasing hyperactivity and
learning
disabilities in children, 13) inducing sedation and tranquilization,
14)
relieving anxiety, and 15) lowering cholesterol.

GHB has been recommended as the anti-anxiety agent of choice for
potentially suicidal patients.

The incredible dichotomy between GHB as a safe miracle nutrient (with
extensive applications to a host of human maladies) and GHB as a
lethal
designer drug (used for date{*filter*} and other nefarious purposes) can
hardly
be more striking. This can hardly be an accident. It must be by
design. But
who's design?

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Medical Uses

The proliferation of GHB INDs establishes clearly that the potential
medical uses of GHB are extensive. The exact medical applications to
which
GHB is presently being applied should be provided in direct testimony
from
practicing physicians using GHB. That some US physicians do not use
GHB is
fundamentally irrelevant. That GHB-ignorant physicians are willing to
testify that GHB has no medical uses is also irrelevant (and
inaccurate).
That police spokespersons are testifying that GHB has no medical uses
and
is "100% abused" (Los Angeles Police Detective Trinka Porrata
testifying
before the Assembly Committee on Public Safety, February 25th, 1997)
is
also irrelevant (not to mention medically incompetent).

GHB is being used in other countries for many medical purposes. One of
the
purposes that deserves special mention is its use in France and Italy
as an
aid to childbirth. It's ability to calm maternal anxiety, protect
against
hypoxic injury to the baby, and accelerate dilation of the cervix
(termed
"spectacular" in one report) provide a graphic contraposition to
allegations of toxicity, {*filter*}ion and lethality.

It is rare to find a substance with as many applications to such a
host of
human maladies. Few medicines have as many beneficial actions upon the
body
as GHB for the prevention and treatment of debility and disease. Even
fewer
medicines have less side effects. The scientific and medical consensus
on
GHB established by conscientious laboratory and clinical investigation
of
the applications of GHB to enhance health and decrease suffering can
only
be sensationalized to a limited degree before all pretense at accuracy
and
honesty must be abandoned. It is unfortunate, but absolutely
necessary,
that we assess the rationale for SB3, SB54, and AB6 in light of this
research.

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Media Reports

Extensive contradictory information on GHB has been presented to the
public
via the media. The experts upon which media stories are based are
associated with 1) the FDA, 2) the DEA, 3) local police agencies, 4)
coroners. 5) doctors and scientists.

Some stories on GHB, for example NBC Nightly News with Peter Jennings,
have
reported glowingly on the current and potential medical uses and
benefits
of GHB. These positive reports are based on medical and scientific
experts
who have researched and tested GHB in clinical settings.

Other reports have referred to GHB as a lethal, brain-damaging, "date
{*filter*}," designer drug. These reports rely upon police and regulatory
agencies for their expert witnesses. The scientific experts (coroners)
that
are potentially qualified to judge GHB are quoted only in a limited
context, and autopsy reports listing GHB as the cause of death have
been
suborned (in a scientific sense) by the "helpful" advice of DEA and
FDA
agents who have "generously" informed local coroners of the dangerous,
lethal and insidious nature of GHB. According to the investigation of
Ward
Dean, M.D., every instance in which GHB has been listed as a cause of
death
involved some other cause of death. Expert witnesses are available to
testify about the details of these cases.

The much-publicized case of Texas {*filter*}ager Hillory Farias is a tragic
case
where DEA and FDA objectives brutally exploited the girl's family to
promote a negative media image of GHB. Very little evidence was found
to
suggested that Miss Farias ever ingested any GHB. Having been told
that
their daughter was poisoned by GHB, the family was encouraged to speak
out
against it with the press. When the family later realized that
Hillory's
death was not due to GHB, they were devastated by the FDA's and DEA's
indifference to human feeling, horrified and shocked that the loss of
their
daughter was used to promote subversive propaganda.

The medical examiner did not report that Hillory's death was caused by
GHB
until a "helpful voice" influenced his determination some 6 weeks
after the
death occurred. This case may reveal the urgency with which certain
government officials feel compelled to frighten the public about GHB.
If
this was the plan, as it appears to have been, it was poorly planned
and
incompetently executed. Miss Farias' symptoms and etiology were
inconsistent with the effects of GHB. Crucial health history factors
were
overlooked. Instead, the medical examiner focused on "traces" of GHB
in the
body as evidence. Since GHB is a natural metabolite of the human body,
traces are always present. Traces of GHB only serve to establish that
one
is an animal and not a plant.

Given the extreme nature of the anti-GHB disinformation campaign, it
is
vital that we examine, in depth, the irreconcilable differences
between GHB
as a deadly, designer, date-rape drug and GHB as a safe and effective
miracle nutrient. This examination is necessary to ensure that public
policy does not subvert public health and welfare.

Furthermore, in any issue of public policy, the rights of individuals
to
"life, liberty and the pursuit of happiness" must not be sacrificed
without
clear cause. I think most health-conscious Americans would consider
good
nutrition to be an essential and unalienable aspect of life, liberty
and
the pursuit of happiness. These Americans made this sentiment well
known to
Congress when the FDA tried, twice, to classify nutrients as {*filter*}
(i.e.,
to restrict nutritional freedom of choice). Even during the height of
the
Gulf War, the volume of mail sent to Congress protesting FDA policy
towards
nutrients exceeded the volume of mail on all other issues combined.
There
is no way to do justice to the deep and abiding suspicion that
nutrition-savvy Americans have for the FDA. The FDA's campaign against
over-the-counter supplements has been so protracted that many
consumers
decide to take a dietary supplement because the FDA says they
shouldn't!
The adversarial nature of the FDA's relationship to non-drug interests
(unpatentable health technologies in general) is not in the public's
interest or for their welfare. First of all, Americans want access to
therapies that are the safest and most effective available, regardless
of
whether or not there are economic interests that can afford the tens
to
hundreds of millions of dollars required for drug approval.
Secondarily, if
there actually were to be a public-health emergency regarding
supplements,
the FDA's advice would be most likely to be ignored by those consumers
most
affected (just as the proverbial shepherd was ignored after crying
"wolf"
one to many times). The FDA has effectively destroyed their
credibility
within a major portion of the supplement-consuming public. This is not
a
trivial problem, nor will it be easily repaired.

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Is GHB a Designer Drug?

No.

The term "designer drug" refers to a synthetic chemical analog of some
other drug which is created in a laboratory for {*filter*} purposes (as
distinguished from chemical analogs designed in laboratory by
drug-company
chemists for testing for the drug-approval process). Since GHB is a
naturally occurring nutrient and human metabolite, it is not a
synthetic
compound. It has been "designed" by nature, or God, not by a chemist.
Furthermore, it is not {*filter*}. Until such time as a law is passed
changing
GHB's legal status, GHB is as legal as any other nutrient, food, or
dietary
supplement.

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Date{*filter*}

Centuries of experience have confirmed that {*filter*} is the date-rape
drug
of choice. Current statistics state that 70% of "acquaintance{*filter*}" or
"date{*filter*}" involve the use of {*filter*} [U.S. Justice Department].
Although
some researchers have suggested that the incidence of date{*filter*} was
not
high, people are now coming to realize the magnitude of the
under-reporting
of this form of {*filter*} {*filter*}. Criminal penalties are becoming
increasingly severe.

Although GHB has been available for years, only recently have there
been
reports of its use in date{*filter*}. There has been one well publicized
case in
Los Angeles associating GHB with date{*filter*}. From the time of that
report,
the media have labeled GHB as a "date{*filter*} drug" attributing qualities
to
GHB that are fictitious. Specifically, the media has reported that not
only
can a victim be rendered unconscious for the purposes of{*filter*}, but
that the
victim can suffer amnesia leaving no trace of memory of their attacker
or
the circumstances leading up to the attack. This is an extensive
distortion
of the facts. These reports may have been designed specifically to
further
a campaign of misinformation about GHB, sparked by the success of
sensational stories about Rohypnol's use as a date-rape drug. Every
story
associating GHB with date{*filter*} cites law enforcement agencies as the
source
of information.

I have no intent to conceal or distort facts related to the subject of
date
{*filter*}, nor to downplay the seriousness of such an {*filter*}. I think that
everybody can agree that there appears to be no shortage of
unscrupulous
individuals with a deficit of respect for the rights of others. I do
believe that it is possible that GHB could be used for purposes of
date
{*filter*}. GHB and {*filter*} have similar pharmacological properties
regarding 1)
induction of relaxation, 2) increasing feelings of physical
well-being, and
3) lowering of psychological inhibitions. Beyond that, there are major
differences. While {*filter*} frequently produces irritability, hostility
and
aggressiveness, GHB universally makes people passive, sociable and
gregarious. The passivity quality of GHB intoxication is not conducive
to
deliberate interpersonal {*filter*}. The lack of aggressiveness with GHB
results from a key difference between the way GHB is metabolized
compared
to the way that {*filter*} is metabolized. {*filter*} is metabolized into
acetaldehyde, a nerve irritant which is chemically related to
embalming
fluid and which is 30 times more toxic than {*filter*}. GHB's metabolites
are
completely non-toxic.

Despite GHB's biochemical inadequacies as a date-rape drug, there may
be
some potential risk in this regard that should be considered. The
problem
is that we have no reliable information about it. We have only
inflammatory
accusations associated with an overtly biased policy of
misinformation. I
fear that misinformation is a bad foundation on which to construct
public
policy.

What should be done about GHB now? Without any specific facts, I can
only
suggest that GHB be compared to 1) {*filter*} (which is currently
unrestricted
to {*filter*}s) and 2) Rohypnol (a drug with serious date-rape abuse
potential
which has recently been classified as schedule IV within California).
The
choice would appear to be between 1) preemptive intervention (schedule
V,
or IV at most) and 2) leaving GHB as an over-the-counter substance
until
good information is available. AB6 specifies schedule II, and SB3 and
SB54
specify schedule I.

Regardless of GHB's status, consumer education about date-rape is
needed.
It is unreasonable to assume that scheduling will eliminate GHB use by
criminally inclined individuals any more than Prohibition during the
20s
eliminated {*filter*}'s use for such purposes. It has been argued that
exactly
the opposite occurs. The largest single advantage of an open market
offers
may be the extremely low cost and high educational efficacy of product
labeling. There are companies that are willing and ready to market
high-purity GHB as a dietary supplement with full-disclosure labeling.
However, due to fears of FDA retaliation, these companies will not
bring
GHB back into the over-the-counter market without some explicit
political
or judicial support at the state or federal level.

---------------------------------------------------------------------------

Does GHB Interfere with Driving?

In high doses, yes. Like {*filter*}, GHB lowers muscle tone and slows
reaction
time. This interferes with coordination and the ability to operate
mechanical equipment. Driving under the influence of GHB should be
considered of similar risk to driving under the influence of {*filter*}.
It
should be (and I believe is) equally criminal within existing law.
Dangerous mechanical equipment should not be operated by people under
the
influence of GHB. The window of this effect is 2-4 hours.

Unlike {*filter*}, GHB does not leave lingering adverse effects on the
brain.
While {*filter*} use causes lingering nervous system impairments (of
which
hangover is just one), GHB wears off completely. The post-GHB state is
characterized by quicker mental abilities, enhanced memory function,
faster
reaction time, and a lingering feeling of wellbeing.

Low-dose GHB (approximately 100-250 mg) are unlikely to impair driving
and
may well improve coordination and reaction time. Driving ability, or
any
physical or mental challenge for that matter, involves a balance
between
mental alertness and physical relaxation. In other words, tenseness
and
nervousness can slow reaction time, impair decision making, and
decrease
performance.

Standard coordination sobriety tests would measure impaired driving
skills
resulting from GHB intoxication equally well as they measure {*filter*}
intoxication. The {*filter*} breath test will not work at all with GHB.
There
may well be a need to make existing methods of assessing GHB levels
more
accessible to law enforcement personnel who may need to establish
forensic
standards to quantify GHB intoxication in persons suspected of driving
under the influence of GHB. I would predict that a urine test would
suffice.

---------------------------------------------------------------------------

Toxicity

GHB is fundamentally non-toxic. Unlike {*filter*}, GHB has no general
toxicity
or organ toxicity. It is cleanly and quickly metabolized by the liver
to
carbon dioxide and water. Unlike {*filter*}, it does not kill brain cells
and
it does not cause cross-linking damage (an aging effect) to either
tissues
or skin (i.e., wrinkling). It does not cause cirrhosis of the liver.
In 30
years of research, no long-term adverse effect has yet been
identified.

These properties make GHB an excellent relaxation and sleep aid for
pilots,
truck drivers, factory workers and military personnel because of the
rapidity at which it is cleared from the system and the complete lack
of
any lasting pharmacological effects. This can not be said for other
sleep-aid {*filter*} which are presently widely prescribed in the US.

---------------------------------------------------------------------------

What Effects Does GHB Cause?

In low doses (less than a gram), GHB is a mild relaxant. It causes a
subtle
drop in muscle tone and a a mild relaxation of inhibitions (making
people
more sociable), very much like drinking a beer or glass of wine. This
effect lasts for 1 or 2 hours.

In moderate doses (1-2 grams), GHB causes strong relaxation (mental
and
physical). This effect happens in 5-10 minutes on an empty stomach and
15-30 minutes on a full stomach (like with {*filter*}, cooking.net">food dramatically
decreases the strength of the effect). GHB slows and deepens
respiration
(causing no net effect on {*filter*} gasses) and it slows heart rate, makes
people passive, calm and possibly sleepy). There may be noticeable
interference with articulation, motor coordination and balance. At
this
dose, the effects can last 2-3 hours.

In stronger doses (2-4 grams), interference with motor control and
speech
is more pronounced. The relaxation effect is quite strong, often
causing
sleepiness or sleep. The sleep induced by GHB is very deep, making it
more
difficult than would usually be expected to wake somebody. This state
has
been inappropriately labeled "coma" by some medical authorities with
minimal concern for the popular perception of such an inflammatory
term.
Comas are technically defined as unarrousability, but the dangerous
aspects
of coma have to do with hypometabolism (inadequate production of
biological
energy) that interferes with normal mental function. During
GHB-induced
sleep, all the normal physiological sleep functions of the brain
(stages 1,
2, 3 and 4, and REM) take place in a normal sequence. The
sleep-enhancing
properties of GHB are potentially of immense value to society. GHB
selectively deepens stage 3 and 4 sleep, which are most frequently
impaired
in the elderly. This is probably the mechanism by which GHB treats
narcolepsy. This may also be the mechanism by which GHB increases
growth
hormone output (which normally takes place during the deepest stages
of
sleep). Not all people fall asleep on GHB. At the 2-4 gram dose range,
GHB's effects last about 3-4 hours.

At high doses (4-8 grams), powerful deep sleep is usually induced
within
5-15 minutes on an empty stomach. The effect will sometimes last up to
4
hours.

At extremely high doses (10-30 grams), the deep-sleep effects last for
much
longer periods. The highest reported GHB dose (termed a "poisoning" by
the
authors) involved a man who took an estimated 15 tablespoons of GHB!
He
woke up 24 hours later feeling groggy with a mild headache. He had no
lasting effects.

---------------------------------------------------------------------------

GHB: Is it Lethal?

No. Everybody reported to have been "poisoned" with GHB has "fully
recovered," even the man who took 15 tablespoons (50-75 grams?). There
have
been no long-term consequences identified in any of these cases
despite
close observation by attending physicians.

Although it is possible that somebody could ingest the 50-150 grams
(2-5
ounces, 5 heaping tablespoons?) that might be expected to be life
threatening, it is exceedingly difficult to do so. In high doses, GHB
causes nausea and vomiting, which strongly limits the maximum amount
that a
person can consume. It is possible that a dedicated person wishing to
commit suicide might be able to take a sleep-inducing dose of GHB and
then,
just before falling asleep, gulp down a huge amount of GHB, but this
is not
something which can be done accidentally. The sodium content alone
(NaGHB
is 17% sodium by weight) is enough to make somebody gag. It is the
equivalent of trying to swallow 2 heaping tablespoons of pure table
salt.

---------------------------------------------------------------------------

Can GHB Contribute to Death by Other Causes?

We don't know. It is possible. But there is no supporting data with
which
to answer this question definitively.

Like {*filter*}, GHB is contraindicated with CNS depressants. GHB should
not
be taken with {*filter*}, tranquilizers (benzodiazepines), sedatives
(barbituates), or opiates (morphine, {*filter*}, etc.). While GHB does not
seriously suppress respiration by itself, CNS depressants do. Although
it
has not been measured, it is possible that GHB increases that
respiratory
suppression when combined with these {*filter*}.

Interestingly, GHB is being used clinically to treat drug {*filter*}ion
and
drug withdrawal symptoms for CNS depressants and opiates. It is
reported to
be outstandingly effective for this use.

---------------------------------------------------------------------------

Patent Status

GHB cannot be patented. It is a generic substance, naturally occurring
in
both plant and animal species, and is therefore ineligible for
chemical
patent. Novel uses for GHB can be patented with use patents, however,
these
are difficult to defend, they do not protect against other, competing
uses,
and they have minimal market value. Use patents are considered
fundamentally worthless by venture capitalists.

The lack of patentability means that no one owns marketing rights to
GHB.
There is no one who has a vested interest in defending the "good name"
of
GHB against prejudicial comments by budget-mongering governmental
agents or
unscrupulous media reporters. This accounts for a large part of the
significant discrepancy between the scientific facts and media
"factoids"
about GHB.

The pervasive consequences of GHB's lack of ownership is best
illustrated
by comparison to a product that is patented, trademarked or owned. If
false
or misleading information is presented to the public about Tylenol,
for
example, McNeil Pharmaceuticals must be reckoned with. Allegations of
death
from Tylenol in the cyanide-tampering incident would directly damage
the
good reputation of the McNeil name and the market value of the Tylenol
brand name. Any media or government representative would be directly
liable
for such comments. At the very least, a demand for public apology
would be
necessary. No such damage, liability or apology is at issue with a
generic
substance like GHB. There is no owner to be damaged. There is no legal
consequence to the person providing false information in a public
forum.

---------------------------------------------------------------------------

Media Misrepresentations About GHB

There was a widespread media report in the fall of 1993, which was
unsupported by the subsequent coroner's report, that GHB played a role
in
the death of actor River Phoenix. At that time, Newsweek reported that
GHB
was "an obscure and dangerous steroid substitute". In fact, GHB is not
a
steroid, it does not act like a steroid, nor can it in any way be
considered steroid like. GHB is a carbohydrate, an entirely different
category of chemical than steroids. The Newsweek report remains
uncorrected. There was no "owner" to complain to Newsweek, there were
no
liabilities to consider, and letters to the Editor went unanswered.

Thereafter, media references to GHB became increasingly laced with
sensationalism and relied less and less on fact. In the last year, the
terminology applied to GHB has become malignant. It is at best
misleading,
but more often completely erroneous. Peter Jenning's of NBC Nightly
News
ended a recent and very positive report on some of GHB's medical uses
with
the statement, "It is important to understand that GHB may cause brain
damage." There is no basis for this statement whatsoever. In more than
30
years of research, there are no reports of GHB-caused brain damage.
None.

Sadly, this incident is not an isolated occurrence. There are many
more
examples. News programs and articles have labeled GHB as: 1) a "party
drug", 2) a "new synthetic weight loss drug", 3) a "night club sex
drug",
4) a "new designer drug", 5) a "lethal drug", 6) a "dangerous
synthetic
steroid drug", 6) a "Killer aphrodisiac", and the list goes on.

The exaggeration of danger by media and governmental agencies has
become
endemic to our society. If we compare the media on GHB with that of
acetaminophen (generic Tylenol), we see severe contrasts. According to
data
from poison control centers around the country, there were 102,619
adverse
effects reported from use of acetaminophen in 1994. The September 1995
issue of American Journal of Emergency Medicine reported 309 deaths
attributed to acetaminophen from just 42 US metropolitan areas.

The reason there are no headlines about Tylenol-induced deaths is that
Tylenol is a major advertiser. Media has a direct vested interest in
seeing
that this information is maintained in proper context and is therefore
minimally reported. Whatever we might think about the need for more
widespread consumer education about the liver toxicity of
acetaminophen,
the number of deaths is quite small compared to the use. The standard
of
liability--can a reasonable person use the drug safely as labeled--is
a
sound basis for public policy. One cannot ignore the costs and focus
solely
on the benefits, just as one cannot ignore the benefits and focus only
on
the costs.

The bias towards GHB is obvious. Have there been any headlines:
"Tylenol--Unsuspected Killer" or "Pain Killer Kills More than Just
Pain."
Media hype about Tylenol is expensive in more than one way. Media hype
about GHB is free.

---------------------------------------------------------------------------

Professional Misrepresentations About GHB

Is the media the source of all this hype? No. Governmental agents are.

The reports on GHB and River Phoenix were supposedly started by a
club-goer
"friend" of River Phoenix. But the media sources were informed of this
"fact" by DEA agent(s). These agents also informed the Los Angeles
media
that GHB stood for a LA designer street drug called "Great Bodily
Harm" or
"Grievous Bodily Harm." Without confirmation, the media lapped it up
and
ran stories about River Phoenix, Great Bodily Harm, and countless
other
DEA-fabricated factoids. Apparently, the reporters did not realize
they
were being had. The acronym GHB does not match Great Bodily Harm
(GBH).

In his investigations of the reported GHB-induced deaths of {*filter*}agers
across the country, Dr. Ward Dean has discovered that "helpful" DEA
and FDA
agents have been working behind the scenes to bring local police and
coroners up to speed on the dangers and lethality of GHB. This
assistance
is the basis of the autopsy reports declaring GHB to be the cause of
death.
Review of these cases reveals that GHB was not the cause of death,
and, at
most, it might have played a contributory role to other causes which,
instead of being cited as the real primary cause of death, were not
even
mentioned as contributing causes. Instead of being impartial,
scientifically based findings, these autopsy findings have become
scientifically suborned by DEA and FDA misinformation. These coroners
have
also been had by the DEA and FDA.

GHB is known to have a high level of safety. Information is available
from
research studies, reference texts, scientists and clinicians to
establish
these facts. The fact that DEA and FDA agents are stating otherwise
does
not require that we re-examine the validity of scientific methodology.
It
demands that we examine the political motivations of the DEA and FDA.
There
are a growing number of experts who can set the record straight on
GHB.
Legislators are encouraged to review the primary literature and invite
these experts to testify.

The same DEA and FDA personnel who are so helpful to local coroners
are
also equally helpful to local police, paramedics, and health
practitioners
who may be exposed to GHB for the first time. Often, these personnel
are so
busy that they do not question the information they are given. They
act on
the the information, and perpetuate it without question.

Fortunately, in our modern age, information is becoming increasingly
more
accessible through enhancements in telecommunications and computer
technology. Many police departments have begun reaching out through
the
Internet to access alternative sources of information which are less
"provincial" than traditional "in house" channels. Not all law
enforcement
personnel have bought into the DEA/FDA story on GHB. I have been asked
to
provide information about GHB by several police departments. In my
opinion,
these departments are primarily concerned about delivering quality
community services to the young {*filter*}s of their community who are
misusing
GHB as a party drug--an admirable goal which I fully support.
Unfortunately, there does not appear to be equal concern for other
members
of the community who are behaving responsibly towards GHB. In fact,
only
two police department personnel who talked to me were even aware that
GHB
was being used by more than just {*filter*}agers, that it is being used
non-party
(medical and health) purposes, and that it has been used for years
before
there was a "GHB problem" that needed addressing.

---------------------------------------------------------------------------

Alternatives to Prohibition

If there is any lesson of which US legislators should be aware, it is
that
prohibition (criminalization) is a dysfunctional method of dealing
with
self-inflicted harm caused by the behavi{*filter*}problems of its citizens.
This
has been attempted with the prohibition of {*filter*} in the 20s and
other
recreational {*filter*} later, with less than satisfactory results. One can
argue that such prohibition experiments have weakened the
effectiveness of
law for the victims of {*filter*} crimes, and provided a powerful source
of
corruption to undermine law enforcement agencies from within. The
secondary
social costs of prohibition are far from trivial, and they should be
carefully considered.

A major social cost of prohibition is product quality. With {*filter*}
prohibition in the 20s, consumers got wood-{*filter*} contaminated
liquor.
This problem completely disappeared when prohibition of {*filter*} was
repealed.

In the case of GHB, the FDA's campaign to imprison GHB manufacturers
and
distributors has resulted in the emergence of home-brew GHB which,
depending on the starting materials and recipe, may be contaminated
with
butyrolactone, toxic solvents, heavy metals, and polyester
derivatives.
This contamination is not a natural product of the GHB marketplace, it
is
an artifact of prohibition. Nobody knows for sure to what extent these
contaminants are causing problems in GHB consumers, however, I have
received reports from people who have been using pure GHB for years
without
incident who have had serious reactions from home-brew "street" GHB.
It is
my opinion that this is a much more serious problem than anybody is
acknowledging, and that a large percentage of adverse reactions to GHB
that
have appeared in the media are reactions to contaminants, not GHB.

I am convinced that the contamination problems would immediately
disappear
if the legal status of GHB as an over-the-counter nutrient were
reaffirmed.
Despite the Dietary Supplement Health & Education Act's removal of
arbitrary FDA powers to reclassify nutrients as {*filter*} whenever they
felt
like it, the campaign to discredit and illegalize GHB has not stopped.
Far
from it. It has shifted into an alliance with the DEA and local police
to
vilify and criminalize GHB on a state-by-state and
community-by-community
basis.

---------------------------------------------------------------------------

Prohibition vs Education

One of the social costs of prohibition is ignorance. When commercial
sales
of a product are shut down by prohibition, legitimate avenues of
consumer
(citizen) education through labeling and adverti{*filter*}t are closed.
Home-brew GHB rarely comes with adequate labeling. In fact, the most
common
form of street GHB is a liquid solution, which it is often inaccurate
as to
potency. It would seem that kitchen chemists are rather more careless
about
such matters than dietary supplement manufacturers.

There is a pressing need for truthful, non-misleading, and
comprehensive
information about GHB. Unlike many nutrients, subtle variations in GHB
dosage can have a large impact on the effect obtained--depending on
the
specific GHB application. Also, GHB has known synergy with other CNS
depressants. While this information can be effectively communicated by
labeling or prescription, the combination of GHB and {*filter*} is
especially
difficult to put into practice. GHB and {*filter*} serve many similar
social
functions--to put inhibited people at ease, to lower interpersonal
barriers
to communication, to relax tension, etc. When GHB and {*filter*} are both
present, people have an added burden of having to think about what
they are
drinking, where they would normally not bother.

In the club scene, {*filter*} is the drug of choice. In fact, it is part
of
the economic structure of the club as a business. Most clubs express
this
economic relationship by imposing drink minimums for their clientele.
While
non-{*filter*}ic beverages are available, there is a certain social
stigma
against ordering a {*filter*} drink or non-{*filter*}ic beer which may be
sufficient to influence those persons with a lack of self confidence
or
assertiveness to order {*filter*} after consuming GHB. Many experienced
GHB
users can do this with little difficulty, because they know their
individual tolerance from experience. To somebody without GHB
experience
and/or {*filter*} experience, the simultaneous use of GHB and {*filter*} may
seem
much too easy and they get into trouble, especially when the
experienced
GHB user incorrectly assumes that their experience with GHB will apply
to
others, or is deliberately playing control games with the initiate.

These same problems exist for {*filter*}. {*filter*}agers taking on {*filter*} for
the
first time have to learn limits. Some {*filter*}agers blow it, seriously. If
they
are lucky, they may just spend time hunched over a toilet throwing up.
Since most {*filter*}s have been through this process, nobody gets alarmed
at
the sight of a {*filter*}age relative throwing up after drinking too much.
With
GHB, however, the situation is different. Most {*filter*}s are not familiar
with
the effects of GHB. While {*filter*}s are willing to let passed-out
{*filter*}agers
"sleep it off" where {*filter*} is concerned, they are not where GHB is
concerned. Due to unfamiliarity with the process, {*filter*}s panic when
they
come across passed-out {*filter*}agers where there are no signs of {*filter*}
having
been consumed. This often results in an quick trip to the emergency
room--a
highly expensive trip in most situations.

{*filter*}-induced sleep and GHB-induced sleep are quite different. While
one
might think that {*filter*}-intoxicated people are sleeping when passed
out,
they really are not. Unlike GHB, {*filter*} strongly interferes with the
brain
functions that take place during sleep. With GHB, the natural sleep
process
are strongly enhanced. So GHB-intoxicated people really are sleeping
when
they are passed out. However, this sleep can be so deep as to render
the
person difficult to awake. With heavy doses, even repeated sharp slaps
to
the face may not arouse them. This can be terribly unnerving to
parents who
do not know that their kids are experimenting with GHB, or to
emergency
medical personnel who are unfamiliar with GHB.

Despite the unfamiliar nature of GHB intoxication, people invariably
recover fully. Unlike with {*filter*}, with GHB there is no hangover, CNS
irritation, {*filter*}-shot eyes, burst capillaries, or sensitivity to
light or
sounds. When the GHB wears off, people generally feel quite wonderful.
This
is not too unexpected. Sleep is a remarkable restorative even when
normal.
When sleep is enhanced, it can be positively energizing. The post-GHB
state
is typically characterized as above average in alertness, energy,
motivation and mood.

Regardless of the m{*filter*}and ethical judgments we may make about the
private
behaviors of other citizens, we must recognize that prohibition has
not
been successful--rather the opposite. Even in the case of suicide,
where
one must acknowledge the irrevocable and self-destructive nature of
the
act, prohibition is at best a marginally effective preventive
strategy.

---------------------------------------------------------------------------

The Ethical Compulsion to Protect

In most people 2-4 grams is sufficient to induce a deep GHB sleep.
Narcoleptics regularly use 4-8 grams to enhance their sleep, but doses
exceeding 8-16 grams can be used on a regular basis without adverse
effects. Of the many reported cases of extremely high GHB intake, all
have
recovered fully. In one case, a man consumed an estimated 15
tablespoons of
GHB! He slept for 24 hours and woke up with a mild headache and
grogginess,
which wore off completely.

All of these documented cases of GHB "poisonings" (as some scientists
call
them) have resulted in full and complete recovery of the "victims."
How do
we then justify prohibition based on harm to the user?

We must also take into account the undocumented reports of GHB-related
deaths that are being sensationalized in the media. Are they really
due to
GHB? Dr. Ward Dean and I have attempted to critically investigate
these
cases with some degree of scientific methodology. To the extent that
we
have not been blocked, we have found that none of them can be
attributed to
any purported toxic effect of GHB.

If there is no physical damage to justify prohibition, is there any
m{*filter*}
or spiritual damage of consequence?

---------------------------------------------------------------------------

Does it Matter that GHB is not FDA Approved as a Drug?

Although the FDA has yet to approve GHB for any medical use (IND
applications are pending), this does not indicate that GHB lacks
medical
value or will not enhance public health. Every substance which is now
FDA
approved was once not approved, yet the its medical value was the same
before as after. The difference between pre-approval and post-approval
is
in the knowledge in our minds, not in the substance.

There is a strong provincial attitude in the United States to discount
the
uses that other countries and cultures put to a substance. This is not
rational or scientifically valid, but it is a common prejudice. US
authorities pander to this prejudice when they declare that, "There
are no
legitimate uses for GHB" [Keith Kamita, Narcotics Enforcement
Administrator, as quoted in West Hawaii Today, February 11, 1997].
This is
absurd. Similar statements have been made before the California
Legislature
[the Assembly Committee on Public Safety].

The situation is much worse than provincialism. It is also elitist.
The
authorities also base their groundless opinion about GHB's
illegitimacy on
ignorance of the clinical uses to which GHB is being applied by
alternative
and complementary medical doctors (who just happen to be unconnected
to the
major (i.e., federally funded) research institutions that also know
nothing
about the medical applications of GHB).

Fortunately, such provincial and elitist attitudes are changing under
the
onslaught of informed consumer demand. There is no reason that
consumers
cannot become as educated about GHB as they are about {*filter*},
vitamins,
diet or exercise.

A growing number of physicians in the US and around the world are now
prescribing GHB to patients for a number of purposes. These include
therapy
for {*filter*}ism and drug {*filter*}ion, treatment of depression and
anxiety,
stress management, sleep enhancement, growth hormone enhancement,
{*filter*}
dysfunctions, autoimmune diseases, trauma medicine, and much more.
These
are not rare conditions. They are serious issues that affect a major
portion of our population. Why would we prohibit something of such
positive
potential without a clear and present danger?

There is no clear and present danger. GHB's safety is universally
acknowledged by scientists. In a 1992 report, Ming-Yan Chin and
Richard A.
Kreutzer, MD., (both staff members of the California Department of
Health
Services) wrote, "there are no documented reports of long term
[detrimental] effects. Nor is there any evidence of physiologic
{*filter*}ion."
Despite Chin and Kreutzer's observations, physiological {*filter*}ion to
GHB is
possible. There are some unusual circumstances that put some
individuals at
risk when high doses of GHB are consumed quite frequently (8-12 times
a
day). But this is a highly unusual circumstance that involves only a
tiny
portion of the population. It is infinitely rarer than {*filter*}ion to
{*filter*}.

The long-term safety of GHB has been verified in narcolepsy studies.
Very
high doses of GHB have been used for very long periods of time in
multiple
studies, and "No investigator reported any long-term adverse effects,
{*filter*}ive or dependent qualities associated with the drug." Chin and
Kreutzer add, "Researchers working with narcoleptics consider GHB a
relatively harmless and effective drug."

When evaluating a drug for approval for medical use, the FDA is
supposed to
employ a risk/benefit ratio to determine whether a drug is safe enough
for
consumption by the general public. Most {*filter*}, even the majority of
over-the-counter (OTC) {*filter*} have significant side effects. The task
of the
FDA is to determine whether the benefits offered by a substance are
sufficient to offset the risks that may be involved with its use. For
example, it is a fairly well known fact that aspirin, ibuprofen and
Tylenol
pose some health risks for a number of people. Consider the following
statistics: According to the 1994 data collected from poison control
centers around the country the number of adverse effects per year for
Ibuprofen: 35,703, Aspirin: 19,796, Acetaminophen (Tylenol): 102,619.
Government data reports of deaths per year from 42 metropolitan areas
for
aspirin: 80 deaths, and acetaminophen (Tylenol): 309 deaths.
Nationwide
numbers are higher. As of 1990, "only 46 adverse reactions to GHB had
been
reported to the CDC--surely constituting only a infinitesimal fraction
of
actual usage--all followed by rapid and complete recovery." [Chin,
1992].
In addition, we need to note that most of these adverse reactions were
merely deep sleep, which prompted concerned relatives to admit victims
to
emergency room facilities. The deep sleep is misleadingly termed
"coma" by
scientists due to some superficial similarities between these
conditions.
Likewise, the muscle relaxation induced by GHB can cause muscle
twitching,
which is called "seizures."

The high numbers of problems and deaths from common medications sheds
light
upon the facts that are important to consider when evaluating the
value or
danger of a substance for human consumption. The benefits from
aspirin,
ibuprofen, and acetaminophen are high enough that the number of
complications and deaths from their use have been considered too
insignificant to remove them from the marketplace. When GHB is
measured up
against some very basic OTC medications in terms of a risk/benefit
ratio,
GHB is far safer and of greater benefit than many common medicines.

More than thirty years of scientific research into the effects of GHB
clearly contraindicates GHB's media image as a menacing poison. Prior
to
the cases of high dose levels taken in 1989 without proper knowledge,
GHB's
safety was largely taken for granted in scientific literature and was
available for sale to the public. A 1964 report lists "very low
toxicity"
as one of the "principle elements" of GHB's pharmacology [Laborit,
1964]. A
1969 summary of its anesthetic uses called GHB "a truly non toxic
hypnotic," repeatedly emphasized its lack of toxicity," and cited
evidence
that it demonstrates "no toxic effects on the liver and kidney"
[Vickers
1969]. In describing the way GHB is metabolized, a 1972 paper mentions
"the
absence of any need of detoxification by the organism" [Laborit,
1972].

The LD50 (lethal dose for 50% mortality) is a way of quantifying the
toxicity of a substance. The LD50 for GHB in rats has been calculated
at
1.7 grams per kilogram of body weight [Laborit, 1964]. Some have
questioned
whether the animal deaths that occur at these dosage levels are due to
the
activity of GHB or to the sodium toxicity that accompanies the use of
salt
form of GHB [Vickers, 1969]. Extrapolating from these data, the LD50
for
humans would be around 115 grams (over a quarter-pound of dry GHB).
While
there are severe inaccuracies in extrapolating from rats to humans,
one can
appreciate the magnitude of GHB's relative safety. Few vitamins can
match
this level of safety.

The benefits of GHB are significant enough that Dr. Martin Scharf,
head of
the Tri-State Sleep Disorder Center of Cincinnati, Ohio recently
reported
on NBC Nightly News that millions of people may potentially benefit
from
use of GHB. Dr. Scharf's experience with GHB is extensive. He is a
valuable
source of solid information, especially regarding GHB's treatment of
sleep
disorders.

As far as side effects from GHB's use, some research programs have
reported
"no side effects at all". This statement, however, needs to be
understood
in context. It is important to understand that if a physician
prescribes
GHB as a sleep aid, then drowsiness is not considered a side effect,
but
rather the desired effect. For clarity, we can list the "possibly
undesirable effects" of GHB as: drowsiness (common), slurred speech
(common, dose related), uncoordination (common, dose related),
dizziness
(common at high doses), nausea (at high doses, it can lead to
vomiting),
headache (somewhat uncommon), sleepwalking (uncommon), bed wetting
(uncommon), and diarrhea (uncommon). Although some of these symptoms
are
disturbing, they pose little danger or risk.

Much of the inflammatory nature of descriptions of GHB may stem from
the
relative unfamiliarity that most physicians have with its properties.
Perhaps a short information video tape provided to emergency rooms
around
the country would reduce this problem.

In 1991, the two scientists from the California Department of Health
Services, Chin and Kreutzer, wrote a report on ten "poisonings"
associated
with GHB. Of the ten "poisonings" reported, four involved "unknown
doses, "
four featured the "co-ingestion" of other {*filter*}, (usually {*filter*}),
one
involved unmedicated epilepsy, and another a history of grand mal
seizures.
Chin and Kreutzer stated that the "more severe reactions...generally
occurred when patients took an unmeasured dose, a particularly large
dose,
or several doses within a short period of time." Such problems are
easily
avoided by following proper directions for GHB's use.

In Section 3 of AB6, we read "There have been reports that
gamma-hydroxybutyrate has caused ailments ranging from nausea and
respiratory problems, to seizures and comas, and according to health
care
practitioners, the drug is very easy to overdose on and has a
potential for
causing death." The "nausea" problems are minor and dose related. The
"respiratory problems" are undocumented. GHB does decrease the rate of
respiration, but it also deepens respiration at the same time. There
is no
net effect on {*filter*} gasses as measured by scientists. "Seizures" is
another
name for myoclonus or muscle twitching. It is seriously misleading and
highly prejudicial to call these muscle twitches seizures. There is
none of
the potential brain damage that can be caused by epilepsy. "Comas"
refers
to really deep sleep. It is highly misleading to call GHB-induced
sleep a
coma. One might just as well state that narcoleptics benefit from
nightly
drug-induced comas, but that would also be misleading. The comas that
follow serious accidents and head traumas are not characterized by
normal
sleep patterns and EEGs. GHB-induced sleep is characterized by normal
(but
deeper) sleep patterns and EEGs. The use of "coma" is deliberately
inflammatory and decidedly misleading.

The statement that GHB "is very easy to overdose on" and has the
"potential
for causing death" is also inflammatory. Salt is very easy to overdose
and
has the potential to cause death. But is this of any significance to
protecting the public health and welfare? It is true that GHB has a
steeper
dose-response curve than {*filter*}. Therefore, if one is looking for a
specific effect at a specific dose, then overdosage is easy. But the
consequences of overdosage is merely deep sleep. There is no long-term
harm
done, other than the loss of a few hours of time. The pejorative
connotations of "overdosage," namely toxicity and long-term damage,
does
not easily happen with GHB. It is possible that a dedicated and
motivated
person can consume 50-75 grams of GHB in one sitting, but it is not
easy to
do. It is like trying to put down 25-50 grams of salt. It is not
possible
that somebody could do this by accident.

The death issue is also inflammatory. The stories of GHB-induced
deaths are
anecdotal, unconfirmed and problematic. Controlled attempts to produce
such
effects in animals have failed. There is no evidence to establish any
"reasonable basis" for GHB having contributed to the alleged deaths.
There
is only speculation. And speculation, in the absence of data, is worth
what
we pay for it.

The attribution to "health care professionals" must be examined. To
whom is
it referring? According to the health care professionals who use GHB,
it is
quite difficult to overdose on GHB and there is no potential for
causing
death in their patients. These health care professionals provide
detailed
instructions to their patients as to what to expect from GHB, how to
explore their individual sensitivity to GHB with a series of
escalating
doses, and which activities should be avoided and which {*filter*} should
not be
taken at the same time as GHB.

While these health-care experts are not at all concerned about GHB
toxicity
within their practices, they are concerned about 1) how the current
politicization of the GHB issue might adversely affect their practice
and
medical license, and 2) the potential health problems that their
patients
might suffer with the use of street GHB of unknown quality. It is
important
to recognize that these concerns are not inherent in GHB. These
concerns
have arisen from the politically motivated actions of Federal
regulatory
agencies towards GHB.

Companies which have a strong interest in marketing high-quality GHB
as an
over-the-counter nutrient are fearful of FDA retaliation were they to
market GHB. Despite the legality of marketing GHB, they realize that
the
FDA has a vast vested interest in keeping GHB out of the
over-the-counter
market. While some of these companies are willing to take on the
challenge
of the media misrepresentations about GHB, none are willing to put
their
businesses (and clients) at risk with the FDA. Although the FDA
repeatedly
denies that retaliation is part if their modus operandi, instances of
egregious retaliation have been exposed by Congressional
investigations.
However, most representatives of companies under FDA regulatory
jurisdiction will only discuss the matter off the record.

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Social Implications for an Aging Population

In the recent NBC Nightly News report on GHB, Eve Van Cauter, Ph.D.,
of the
Department of Medicine of the University of Chicago reported that at
the
age of 25, the average amount of deep slow wave sleep a person
receives
each night is 90 minutes. When a person reaches age 40, this time
decreases
to 30 minutes; and by the age of 60, the slow wave sleep each night
may
only be 5 minutes. It is the slow wave or deep sleep which provides
the
body with profound rest and it is during this period the body produces
many
of its hormones (i.e., growth hormone). Ms. Van Cauter stated that use
of
GHB as a sleep aid significantly increases the amount of slow wave
sleep
each night which provides the beneficial result of allowing the body
more
time to restore itself. This aspect of GHB's function implies possible
anti-aging and immune system stimulation and calls for further
research to
determine whether this is the case. Many physicians are already
calling GHB
a potent "youthifier".

On a recent Hard Copy, young men falling asleep on the sidewalk
outside a
nightclub were presented. The nodding heads and strain to keep the
eyes
open were quite typical of GHB's sleep inducing action when taken in
larger
amounts. For someone unfamiliar with GHB, these pictures might be a
source
of serious concern. But for someone familiar with GHB and the plight
of
millions of people who suffer from insomnia or other insidious sleep
disturbances, this could be a blessing. The fact that a few people are
testing their GHB limits in a public setting, however inappropriate,
should
not be used to replicate their carelessness by passing a law that will
adversely affect thousands more people than will hopefully be
protected.
Increasing numbers of physicians are coming to consider GHB as the
best aid
for sleep available. Let's not throw the baby out with the bath water.

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Anti-Hypoxia

At very high doses of GHB, some cardiac and respiratory depression can
occur. This leaves the question as to why people have not died who
were
found with such low rates of respiration that some rescue workers have
referred to the patient as "clinically dead" (although they may have
been
unqualified to make this determination). The answer may be the quick,
efficient and effective work of paramedics. However, given the
widespread
recreational use of combining {*filter*} with GHB, the answer is more
likely
because GHB may protect the brain and heart during conditions which
depress
vital functions and oxygen availability. In animal studies, GHB has
extended survival time under conditions of low oxygen supply (hypoxia)
up
to eighty-five percent [Artru, 1980], and has increased the survival
time
of the mouse heart when completely deprived of oxygen (anoxia)
[Vickers,
1969]. Unlike all other known anesthetics, GHB does not result in an
overall decrease in oxygen consumption by the body [Laborit, 1964].
GHB
also protects against various kinds of arrhythmia (irregularity of
heartbeat) that can be induced in animals [Vickers, 1969; Laborit,
1964].
It is also suspected that GHB possesses a protective function which
involves a reduced oxygen and glucose requirement for the brain cells.
[Chin and Kreutzer, 1992; Artru, 1980] This is one of the reasons GHB
is
considered quite safe and may perhaps be ideal as an anesthetic for
childbirth. GHB is considered protective not only for the birthing
mother,
but also for the newborn infant.

GHB has gained some popularity as an obstetric anesthetic in Italy and
France [Vickers, 1969]. It has been attributed with "spectacular
action on
the dilation of the cervix" [Laborit, 1964]. Other attributes of GHB
that
can be valuable in childbirth include decreased anxiety, greater
intensity
and frequency of uterine contractions, increased sensitivity to
oxytocic
{*filter*} (used to induce contractions), preservation of reflexes, a lack
of
respiratory depression in the fetus, and protection against cardiac
anoxia
(which could be especially important when the fetus's oxygen supply is
threatened by wrapping of the umbilical cord around the neck)
[Vickers,
1969; Laborit, 1964].

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{*filter*}ism and Withdrawal

GHB shows great promise in the treatment of {*filter*}ism. In Europe, one
of
its primary uses is to relieve withdrawal symptoms, cravings, and
anxiety
among {*filter*}ics. A 1989 study was conducted with {*filter*}ics according
to a
methodologically rigorous, double-blind, placebo-controlled format.
The
treatment was considered very successful. After the first
administration of
GHB, "nearly all withdrawal symptoms disappeared within two to seven
hours...." The subjects in this study were given steadily decreasing
doses
of GHB for seven days. During this period, the intensity of withdrawal
syndrome, measured on a scale of 0 to 3, remained below 2, the rating
designated for "moderate." Minimal side effects were observed. The
researchers concluded, "the results clearly indicated that GHB is
effective
for the suppression of withdrawal symptoms in {*filter*}ics"
[Gallimberti,
1989].

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Depression

Regarding the effect of increased levels of happiness, some US
psychiatrists now prescribe GHB as an anti-depressant agent used
during the
day in several small doses. The reports have been noteworthy. Several
report increased levels of happiness are sustained even when the
person no
longer has GHB in their system. Claude Rifat, a French biologist,
reported,
"GHB may be the first authentic anti-depressant. GHB suppresses
depressed
ideation with amazing rapidity..... (GHB) strongly stimulates the
desire to
be and remain alive despite unfavorable circumstances. Despair
disappears,
replaced by a feeling that life is worth living. GHB can suppress
depression within hours. No conventional so called anti-depressant
does
that. Conventional antidepressants can takes weeks or months to
alleviate
suffering. GHB treatment is also very short; less than a month of
treatment
is usually effective, as opposed to months or years with other
treatments."
Increased levels of happiness may also be the result of the extended
periods of deeper sleep and a more rested body.

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Mental Enhancement

Mental clarity, perception and judgment all appear to improve with low
dose
use. Rapid eye movement sleep and protein synthesis -- processes which
may
be linked, and both of which are facilitated by GHB--have been
correlated
with periods of intensive learning [Laborit, 1972]. GHB has also been
shown
to stimulate the release of acetylcholine, one of the brain's own
intelligence and alertness boosting chemicals [Gallimberti, 1989].
Preliminary testing suggest improved reaction times and perceptual and
cognitive reflexes with low dose use of GHB. These findings of
increased
alertness are surprising to those accustomed to expecting GHB to act
solely
as a sedative. Perhaps the answer lies in the fact that nature
designed
this molecule.

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GHB Availability

GHB is now available through any local pharmacy in the United States.
It
has been sold in the United States for decades. Some time during the
80s,
GHB entered the over-the-counter supplement market. In 1990, the FDA
issued
a press release which declared GHB to be an "unapproved new drug."
Retail
sales ended and non-prescription GHB was driven into the underground.
Medical demand was met by compounding pharmacies. Recently, it has
become
available by prescription through regular pharmacies as well. The FDA
is
aware of GHB's distribution through pharmacies and has not interfered
in
any way.

After the FDA's precipitous actions against GHB in 1990, GHB consumers
began to look for other sources of GHB. While a significant number of
people chose to import European GHB through the FDA's 1988
personal-use
importation policy, high costs have driven many consumers to buy GHB
on the
street or make their own GHB at home. The chemical process for making
GHB
is quite simple (using only butyrolactone, hydroxide and water) and
uses a
minimum of equipment (I can do it with a Pyrex bowl, pH papers, a hot
plate
and a microwave oven).

Butyrolactone is a bulk chemical used as a solvent and chemical
intermediate. Hydroxide exists in many forms: sodium hydroxide (used
in
drain cleaners), potassium hydroxide (a chemical reagent and
hydroponics pH
balancer), magnesium hydroxide (milk of magnesia) or calcium hydroxide
(slaked lime). [Actually, carbonates (laundry detergent and baking
soda)
are sufficiently alkaline to hydrolyze butyrolactone into GHB].
Needless to
say, control of these chemicals would be problematic.

While this synthesis is exceedingly simple, even by the standards of
first-year organic chemistry students, there may be problems when it
is
attempted by inexperienced consumers. If directions are ignored,
low-quality ingredients are substituted for pure starting materials,
the
reaction is not evaporated to dryness, or flammable solvents are used,
there may be problems. There could be fire risks, or there could be
various
impurities that might pose significant toxicity to consumers. Many
consumers purchase home-brew GHB from their friends or from strangers.
Much
of this GHB is sold in a liquid form that may or may not have been
evaporated to dryness before being sold. Consumers do not know how it
was
made, nor do they have any real assurances of the quality of the
product.
It is even possible that careless individuals are using
industrial-grade
engine degreasing solvents to make GHB. I fear for the spectrum of
contaminants that might be present in such material.

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Consumer Protection and Public Welfare

Detective Trinka Porrata testified before the Assembly Committee on
Public
Health that street GHB samples had been widely tested by the Los
Angeles
Police Department. Perhaps the results of these tests should be made
available to committee members to assess the public health dangers of
continued de facto prohibition of this legal nutrient by policymakers
and
agents of the FDA. I have no doubt that were there to be conspicuous
official acknowledgment of GHB's legal status as a dietary supplement,
that
reputable manufacturers would quickly enter the market and eliminate
the
demand for GHB of unknown quality--and provide much needed educational
outreach to interested consumers.

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Conclusion

Consumer protection and public health would be better served by
formally
acknowledging the legal status of GHB and encouraging it to be
manufactured
and distributed by reputable vendors who can compete on the basis of
product quality and extensive labeling. The poor quality of street GHB
and
the paucity of accurate consumer information about GHB are the biggest
long-term contributors to public health risk. The GHB "crisis" has
been
manufactured by the FDA, aided and abetted by the DEA, compounded by
local
police, inflamed by the media, and perpetuated by ignorance. We do not
need
to have this become a permanent part of our culture as law. We do not
need
to disenfranchise patients, impair the practice of medicine, and drive
citizens to obtain their cooking.net">food supplements in the drug underground. The
public welfare will be best served by treating the public as
responsible
citizens with the capacity to guide their own nutrition decisions--in
consultation with their chosen health-care professionals.

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