Many research scandals involve deception. And some scandals, such as the one at the Jewish Chronic Disease Hospital, include the administration of dangerous substances. Still others involve outright racism, such as the Tuskegee syphilis study. But it is a rare scandal that involves all three. In the early 1990s, the University of Minnesota’s Department of Psychiatry hit the trifecta.
In 1993, when the University of Minnesota was under fire for covering up research fraud by Dr. Barry Garfinkel, the university found itself with yet another psychiatric scandal. Dr. James Halikas, a tenured professor in the Department of Psychiatry, had gotten permission from the FDA to test a drug called gamma hydroxybutyrate, or GHB, for opiate addiction. He began by recruiting uneducated Hmong refugees who did not speak English. The Hmong patients had become addicted to opium in Laos, where the drug is often used as a painkiller. Although they had come to the university to get methadone maintenance treatment, the patients had discovered that the methadone clinic was closed to them. Why? Because Halikas had decided that Southeast Asians were taking up too many spots at the clinic. He was only admitting non-Asians.
Instead, according to the FDA, Halikas enrolled ten of those Hmong patients in his GHB study. Although they complained bitterly that GHB didn’t work and repeatedly asked for methadone, it was not until a formal complaint was lodged by another faculty member, Dr. Sheila Specker, that an investigation was triggered. It soon became clear that Halikas had never actually obtained informed consent from his subjects. In fact, it is not even clear that the subjects even knew they were in a research study. (This was not because Halikas didn’t know better; he was a member of the university’s Institutional Review Board.) According to a later investigation by the FDA, several of the subjects were severely depressed and at risk of suicide, and should have never been enrolled in the study, even if they had given their consent. Although Halikas told the Star Tribune that GHB is “so mild that it has been used in Europe as a children's sedative,” it is in fact a central nervous system depressant that is sometimes used as a date rape drug. At the time of the study it had been linked to seizures and coma. The FDA found that Halikas had dispensed it in dangerously high doses.
According to the Star Tribune, although the university investigated the complaint about Halikas, it did not inform state licensing officials who have jurisdiction over the drug program. Nor did it bar Halikas from conducting research. That did not happen until 2000, when the FDA formally “disqualified” him as a clinical researcher.