Prom night incident leads to GHB prosecutions - gamma hydroxybutyrate

FDA Consumer, June, 1991 by Dixie Farley

In Duluth, Ga., May 11, 1990, it was prom night. Before getting ready for the dance, a teenager drank a potion of water and two teaspoonful of Somatomax PM, a powdery substance his friend had bought at a health food store. He had heared it would give him a "high."

The substance was gamma hydroxybutyrate (GHB), a dangerous and illegal drug sold under numerous names and touted to build muscle, reduce fat, and induce sleep. Within 20 minutes, the young man was beyond "high" and beyond sleep. He was in a coma.

Luckily, that young man's parents soon found him, and with emergency treatment he recovered. The parents reported the incident to FDA, noting that hospital physicians said if their son had been found a half hour later he might have died.

FDA launched an intense investigation that by November, with the cooperation of several government and private agencies, had uncovered 57 cases of GHB-related illness. Four months later, on March 13, 1991, FDA and the U.S. Department of Justice announced two indictments citing a firm and five individuals on criminal charges of making, distributing and promoting GHB.

A grand jury in Tucson, Ariz., indicted Amino Discounters Ltd.; Mark Thierman, the firm's president; Sherry Cano, secretary-treasurer; and Robert Hilton, an employee who also participated in manufacturing and distributing the drug, sold under the brand name Somatomax PM. In addition, in FDA's first civil fraud case under the Injunctions Against Fraud Provision of the U.S. Code, the court froze the assets of Amino Discounters, Thierman, and Cano, based on the government's showing that the defendants were engaged in mail and wire fraud.

In a separate indictment in San Francisco, a grand jury named Edward Byrd and Jerald Bloch, operators of the California Body Club in San Leandro and Carmel, with illegal distribution of GHB.

The Arizona defendants had been making the GHB in a facility that wasn't registered with FDA as a drug manufacturing site. Donald Leggett, a compliance officer with FDA's Center for Drug Evaluation and Research, explains, "Thierman and the others were using an 'underground' laboratory, purposely disguising receipts and storage facilities for the raw and finished product. The health dangers of the illegal drug were magnified by this manufacturing process because it was clandestine, and therefore uninspected, and was carried out under uncontrolled conditions by untrained personnel."

Widespread Problem

The results of such drug production without appropriate safeguards soon became clear. About the same time investigators from FDA's Atlanta district office were following up the Duluth incident, other reports of similar injuries surfaced. On July 23, FDA's San Francisco district office received a report of a person who became unconscious after taking the product. On Aug. 7, the San Francisco Bay area regional poison control center notified FDA in San Francisco and the California Department of Health Services that GHB poisonings had caused symptoms such as stomach and intestinal cramps, breathing difficulty, and uncontrolled seizure-like movements. On Oct. 3, FDA's Atlanta office learned of six more cases of GHB poisoning from a state epidemiologist and the regional poison control center there.

FDA's investigationlk widened from Atlanta and San Francisco to areas under the jurisdiction of FDA offices in Boston, Cincinnati, Dallas, Denver, Los Angeles, Minneapolis, New Orleans, New York, and Orlando, Fla.

Evidence showed the poisonings were nationwide. Through health food stores, mail order outlets, body building gyms, and fitness centers, victims were buying GHB as granules, capsules and powder under various generic names, including gamma hydroxybutyric acid, sodium oxybate, and gamma hydroxybutyrate sodium.

FDA and California authorities in early November embargoed 716 bottles of GHB at a firm in Sunnyvale and seized about 1,000 bottles at a location in San Francisco, thus removing some $100,000 worth of the product from the market.

In a press release dated Nov. 8, 1990, FDA warned:

* Anyone taking GHB outside of physician-supervised studies should stop immediately.

* Anyone taking GHB who has headaches, nausea, vomiting, diarrhea, seizures, uncontrolled shaking, or central nervous system disorders such as unexplained drowsiness should immediately seek medical attention.

* Physicians treating patients with these symptoms should report the cases to the local poison control center.

A poll of poison control centers by the U.S. Centers for Disease Control, reported in the Nov. 30, 1990, Morbidity and Mortality Weekly Report, revealed GHB-related illnesses in California (25), Georgia (15), Florida (7), South Carolina (3), Arizona and Minnesota (2 each), and Ohio, Texas and Virginia (1 each). Patients reported that within 15 to 50 minutes of taking one half to three teaspoons of GHB, they developed symptoms such as vomiting, drowsiness, dizziness, tremors, seizure-like movements, unconsciousness, slowed heartbeat, lowered blood pressure, and breathing difficulty. Spontaneous recovery occurred in 2 to 96 hours. Severity and duration appeared to depend on dose, concurrent use of other depressants (usually alcohol), or both. No deaths were reported, but most patients required emergency room care.