Philadelphia Inquirer
April 8, 1999
[Erowid Note: GHB became illegal to possess or sell in the United States in March 2000]
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."
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."