One Drug, Two Faces

By Jill J. Barshay

Minneapolis, MN - August 6, 2000

This article originally appeared in the Business section of the Minneapolis STAR TRIBUNE Sunday Metro Edition on August 6, 2000. A correction was printed on Sunday August 13, 2000. Copyright 2000 by Minneapolis STAR TRIBUNE. Reprinted by permission of Minneapolis STAR TRIBUNE via the Copyright Clearance Center.

GHB gained national notoriety as a date-rape drug. But the bill outlawing it contained one exception: for Minnetonka-based Orphan Medical, which thinks the compound will help narcoleptics -- and transform the company.

In March 1998, a little-known pharmaceutical company in the Twin Cities received the first results of a two-year clinical study of its new treatment for narcolepsy. Such moments are full of anticipation and dread for any drug maker, but all the more so for Orphan Medical Inc., which had yet to produce a meaningful product or a dollar of profit in its four years of existence.

The results of the study promised both. Not only did the company's drug, Xyrem, reduce the classic sudden sleep attacks among trial patients, it also left many feeling less sleepy throughout the day. But those same hopeful results set Orphan on a collision course with the nation's drug laws. Xyrem is the company's name for gamma hydroxybutyric acid, or GHB, infamous as a date-rape drug and widely abused at so-called rave parties.

The compound has been linked to more than 60 deaths and 1,600 emergency room episodes nationwide, its victims ranging from small-town schoolgirls to former Minnesota Timberwolves player Tom Gugliotta, who suffered a seizure and nearly died last December after unwittingly taking a supplement containing a related compound that metabolizes into GHB.

GHB is considered so dangerous that in February the U.S. government banned its sale, use or possession, putting it in the same class of drugs as heroin and LSD. The law contained only one exemption -- for Orphan Medical. Through the kind of intense lobbying effort that would seem beyond its resources, the Minnetonka-based drug maker won the right to keep developing the drug. But most states, which have the power to enact stricter standards than the federal government, still classify GHB as a banned substance with no legitimate medical use, meaning that for now Orphan wouldn't be able to sell even FDA-approved GHB there. (Editor's correction: there are 14 states with stricter standards)

Even if it can obtain FDA approval, expected this year or early next, and win at the state level, Orphan faces a task that has proved difficult even for giant competitors - controlling access to a drug with clear abuse potential in the age of the Internet pharmacy.

Promise and Threat

The promise of legal GHB seems as great as the threat.

For Bob Cloud, it made a normal life possible. The 56-year-old Cincinnati attorney is a cataplectic who used to lose muscle control and collapse suddenly, temporarily paralyzed, whenever he became excited or angry. It could happen up to 25 times a day. Once an attack came over him on a department store escalator. He tumbled to the bottom where, unable to move, his head was struck repeatedly by the moving steps until help arrived.

"Within a week or two, [GHB] eliminated 90 to 95 percent of my cataplexy," said Cloud who found other drugs ineffective and has participated in clinical trials of Xyrem. "Otherwise, I clearly would have been disabled. I was on the brink of leaving work."

But GHB is the chemical that was slipped into the Mountain Dew of 15-year-old Samantha Reid at a Grosse Ile, Mich., party on a January evening in 1999. By the next day, she was dead. Her friend, also drugged, was left in a coma.

Between these two stark extremes are the thousands of young adults who use GHB recreationally. Known by myriad names -- from Liquid X to simply "G" -- GHB has become a mainstay of the rave scene over the past five years, along with Ecstasy and Rohypnol -- the latter also known for its use in date rapes. Toted in water bottles and readily available through the black market, GHB is sold on the reputation of providing a quick, sexually charged high on the dance floor.

GHB slows down the central nervous system. As with other depressants, like alcohol, a moderate dose can produce a feeling of relaxation. But large doses of GHB, especially when mixed with alcohol, can bring on coma and death.