FDA RELUCTANT TO RELEASE GHB FILES

Drug Companies Want To Keep Recipe For 'Date-Rape' Drug Secret

Variants of the illicit drug may be found to have medicinal value - and
legal profit potential.

What do you get when you mix an industrial solvent used for stripping the
wood on bowling alley floors with the active ingredient in Drano?

For federal authorities, the result is a dangerous drug in league with
heroin.

But for drug manufacturers, the concoction boasts at least three attractive
features: It's supposed to be a sleep-promoter, a muscle-builder and a
fat-burner.

The substance is GHB, gamma hydroxybutyrate, commonly known as the
"date-rape drug." On Feb. 16, four Roanoke men were charged with illegally
making GHB, some of which was eventually slipped into the drinks of two
sisters at a nightclub. The two later broke into convulsions and required
emergency medical care.

As part of building his case for trial, prosecutor Anthony Giorno requested
records from the Food and Drug Administration about GHB. But the FDA's files
include information submitted by some drug manufacturers that have been
lobbying the agency to approve new versions of GHB, which the FDA banned in
1991. These companies are concerned that in the shuffle of the trial, their
trade secrets, potentially worth a windfall if the FDA does determine their
formulations are safe and approves them, will get leaked.

Meanwhile, federal and state authorities have signaled they have no
intention of easing up on GHB.

Two days after the Roanoke indictment came down, President Clinton signed
into law the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition
Act of 2000, named for two young women who died after unwittingly ingesting
GHB. The legislation amended the Controlled Substances Act to elevate GHB,
also known as G, Liquid X, Grievous Bodily Harm and Georgia Home Boy, to
Schedule One status. This designation, determined by the Food and Drug
Administration, means the drug has a high potential for abuse, that there is
no medically accepted use for it in the United States, and that even under
medical supervision, the drug's use is considered unsafe.

Virginia has also cracked down on GHB . Effective July 1, the manufacture,
sale, distribution or possession of GHB was made a felony. Before that,
possession of GHB was legal in Virginia.

GHB's popularity has grown significantly during the past few years. In 1994,
less than 100 people were admitted to emergency rooms because of bad side
effects from consuming GHB, said James Gregorius, resident in charge of the
Roanoke office of the Drug Enforcement Administration. By 1998, the number
had skyrocketed to about 1,300 cases, Gregorius said.

Classified by the DEA as a central nervous system depressant, GHB has been
used by those craving sleep , bodybuilders and people in search of a quick
high.

The change in GHB status will not affect the case against Gary Duane Ellis
Jr., Tracy Christopher Lupton, Shawn Franklin Plogger and Joseph Blake
Bailey, said Giorno. Ellis was indicted on three counts, Lupton on two, and
Plogger and Bailey on one each of illegally making the drug. The defendants
face up to three years imprisonment and a maximum fine of $250,000 on each
count.

"At the time the offenses were committed, GHB was not Schedule One," said
Giorno of the operation he said ran from 1996 through 1999. "If I was going
to prosecute it now, it's treated the same as crack or cocaine."

GHB was legally sold in health food stores until the FDA banned it because
of reports of health problems stemming from its use . But some drug
companies are hoping to develop versions of GHB the FDA will approve for use
in the treatment of cataplexy, for example, a disease that causes total loss
of muscle control in narcoleptics. These companies are loath to see what
they consider privileged and confidential information disseminated.

"These guys are saying to the FDA: 'We can take the GHB and make it safe for
certain purposes. We're showing this to you, the FDA, to see if it's viable,
but we don't want it out there,'" said Giorno, who declined to name the
companies involved.

"The problem is, you've got these people out there cooking it on their
kitchen stove," Giorno said . Indeed, a quick search of the Internet reveals
that plenty of entrepreneurial GHB-makers are more than willing to share
their recipe with the world.

After the indictment, Giorno submitted a written request to Judge James Turk
seeking access to the files. Judge Turk stipulated the turnover of the
files, but issued a protective order this week that strictly limited the
access of the materials to the attorneys working on the case, medical and
scientific experts not employed by drug companies, legal staff and the
defendants.

Turk further ordered that to gain access to the information all
non-government employees or witnesses must sign a document agreeing to keep
the information locked up when not in use and to guard the key, to not share
the material, and to return the information when the trial is over.

The trial is scheduled to start Nov. 13.