A GHB BAN COULD HURT SOME

The "Date Rape" Drug Has Shown Promise In Treating Cataplexy, A Rare
Neurological Disorder.

A push in Pennsylvania to criminalize a drug used in date rapes is worrying
patients who need the drug to treat a rare sleep disorder.

GHB, or gamma hydroxybutyrate, is a clear, flavorless, liquid sedative that
can have intoxicating effects. Slipped into a drink, it can bring on
unconsciousness and amnesia. GHB is easily obtained over the Internet, and
has been involved in more than 20 sexual assaults and 3,500 cases of
recreational abuse, including 600 overdoses and 32 deaths, according to the
U.S. Drug Enforcement Administration.

While GHB is not included in the federal controlled-substance law, 12
states -- including New Jersey -- have enacted statutes to ban it. At least
eight other states have regulated it as a controlled substance, but allow
it for medical use.

In Pennsylvania, Attorney General Mike Fisher is leading the effort to
outlaw GHB. Last year, he petitioned the state Health Department to list
GHB as a controlled substance with maximum restrictions and penalties. That
would put GHB into a category with heroin -- a high potential for abuse; no
medical use; and illegal to use, possess, make or sell. Fisher also asked
that makers of a related drug called GBL be required to register with the
state.

When his petition did not succeed, Fisher turned to the legislature.

"Because GHB is not illegal under Pennsylvania law, narcotics agents are
not allowed to stop this deadly drug from getting into the wrong hands,"
Fisher testified last month at a hearing before the Pennsylvania House
Judiciary Committee.

But GHB isn't all bad. In clinical tests, it has shown promise in treating
cataplexy -- the sudden, temporary muscle paralysis that is sometimes part
of narcolepsy, a neurological disorder that causes chronic daytime
sleepiness. Of the nation's 250,000 narcoleptics, an estimated 100,000 also
suffer varying degrees of cataplexy, according to Narcolepsy Network Inc.
of Fairfield, N.J.

"If development of GHB were to be denied, for patients like me, it would be
a crime," said Bob Cloud, 55, a Cincinnati lawyer who heads the network. "I
take it every night and have never had side effects. . . . Before I started
using it, I was at the point where I couldn't function. I was falling down
- -- collapsing -- several times a day."

Orphan Medical Inc. of Minnetonka, Minn., began clinical testing of GHB for
cataplexy five years ago at the request of the Food and Drug
Administration. The company hopes to gain final FDA approval within about a
year.

The company endorses efforts to make GHB a controlled substance -- but in a
less-restrictive category that would allow manufacturing and use for
medical purposes.

Orphan Medical's GHB is manufactured at a plant in Conshohocken.

"We'd like to applaud the attorney general for being out front on this
illicit-use issue," said Orphan Medical vice president Patty Engel. "But if
we wholesale-ban GHB without recognizing that it has a high medical value
for people with this rare disease, it's going to force them to get it
illegally. . . . It would put severe limitations on us in terms of
manufacturing as well."

Marlene Haffner, director of the FDA's office of orphan product
development, said, "If the drug is[banned], the company will have trouble
getting it to patients. And these patients with cataplexy have no other
drug" to treat loss of muscle control.

GHB abuse first became a problem more than a decade ago, when it was sold
as a dietary supplement in health food stores and some fitness clubs that
touted its supposed body-building potential. By 1991, the FDA and the U.S.
Department of Justice had taken action against numerous companies involved
in marketing products containing GHB or the related GBL (gamma butyrolactone).

But while the FDA can outlaw the marketing of unapproved drugs, it cannot
stop people from possessing or consuming them. Do-it-yourself kits and
recipes for GHB and GBL are available on the Internet.

As law-enforcement officials try to fight the recent resurgence of GHB
abuse, there is disagreement over whether the drug has any medical value.
In Michigan, for example, lawmakers added GHB to the most restrictive
category of controlled substances, declaring it had no medical use. But
Rep. Bart Stupak (D., Mich.) recently introduced a federal bill that would
permit prescription use of GHB, while punishing illicit possession as
severely as heroin possession.

Fisher's petition to Pennsylvania health officials prompted a state Health
Department advisory board to hold a hearing on GHB. Rejecting Fisher's
advice to classify the drug like heroin, the board recommended that GHB be
added to a less-restrictive category that would allow prescription use. The
secretary of health has not yet acted on the recommendation.

In the legislature, Rep. Kerry Benninghoff of Centre County introduced a
bill that would allow prescription use of GHB -- then amended the bill last
week to tighten conditions under which the drug would be dispensed.

"I live in a college town, and we've had two[recent]GHB overdoses. This
isn't something we want to play around with," said Benninghoff, whose
district includes State College. "But we don't want to be hindering use for
cataplexy, either."

Fisher said Monday that he still believes GHB should be outlawed -- at
least until the FDA approves it for medical use. His position is supported
by, among others, the Harrisburg-based Pennsylvania Coalition Against Rape.

"It's hard for me to say to a parent whose child has been raped while under
the influence of GHB that we don't have adequate penalties on the books,"
Fisher said. "If we can come to a resolution that would help law
enforcement but not impede the clinical trials, I'd be willing to look at
that. We do have conflicting forces."