FDA Ain't Doing Their Job!!!!!!!!!!!!!!

[Guest guest]

SOURCE:

http://www.sundaytimes.news.com.au/common/story_page/0,7034,4726942%255E401,

00.html

 

Patients to take date-rape drug

From correspondents in Washington

18jul02

 

THE notorious date-rape drug GHB has won US government approval to treat a

rare but dangerous complication of the sleep disorder narcolepsy.

 

The drug will be sold under some of the most severe restrictions ever

imposed on a medicine.

Today's Food and Drug Administration (FDA) approval carves out one medical

use for an otherwise illegal chemical.

 

Throughout the 1990s, the government cracked down on illegal GHB use as a

party drug and sex and athletic enhancer.

 

Because it can knock people out it was also used as a date-rape drug.

 

Several dozen deaths have been blamed on the chemical, but GHB has proved

hard to stop because it is easy for people to mix it up with some common

chemicals.

 

Now the maker of the only FDA-approved version, Orphan Medical Inc, will

have to balance how to get GHB to the relatively few patients it could help,

while keeping it from falling into the wrong hands.

 

" No system, I believe, is foolproof. But there will be very close tabs " kept

on every GHB shipment, said Dr Russell Katz, FDA's neurologic drugs chief.

 

Narcolepsy is marked by recurring episodes in which patients suddenly fall

asleep, from a few seconds to an hour.

 

GHB doesn't treat that symptom, but could help anywhere from 20,000 to

50,000 narcolepsy patients who also suffer from cataplexy, a muscle-weakness

complication that can cause people to collapse without warning.

 

Orphan Medical's version of GHB, to be sold under the brand name Xyrem,

marks the first FDA-approved treatment for cataplexy.

 

Studies suggest Xyrem could reduce cataplexy attacks by up to 70 per cent.

 

Originally developed as a surgical anesthetic, GHB was pulled off the market

because of side effects. It depresses breathing and can cause coma, and even

kill.

 

In 1990, some companies began selling it as a dietary supplement, and use as

a recreational drug - under such names as Georgia homeboy, cherry meth and

liquid ecstasy - took off.

 

Colourless and odourless, it made headlines when people slipped it into

drinks, knocking out victims who often had no memory of what happened.

 

Orphan Medical said it would begin sales by year's end, but did not release

a price.