Panel urges FDA to allow ibogaine tests on addicts

August 26, 1993|By Los Angeles Times

WASHINGTON -- A federal advisory panel recommended yesterday that the Food and Drug Administration allow limited human testing of a potent hallucinogenic drug, ibogaine, that is believed to help some heroin and cocaine addicts overcome their addictions.

After strenuous debate, the committee voted to allow University of Miami researchers to begin testing the drug on as many as 12 human volunteers, according to a member of the research team that submitted the formal proposal to the FDA.

The panel -- the Drug Abuse Advisory Committee -- asked that the experimenters reduce the dosage from the levels originally proposed and requested that further experiments of the effects of ibogaine on monkeys be conducted simultaneously, said Dr. Deborah Mash of the University of Miami, who testified before the panel. The final decision on the human tests will be made by the FDA, which generally follows the recommendations of its advisory committees.

In making their case for the trials, Dr. Mash and other proponents of the drug cited recent reports from the Netherlands indicating that some addicts lose their craving for narcotics after a single treatment with ibogaine.

But the evidence is anecdotal, and the treatment controversial: Ibogaine, derived from the root of a West African plant, is said to produce an intense, trip-like experience, with vivid hallucinations and unsettling insights. Some researchers believe it may curb addiction by damaging brain cells in the cerebellum, a region of the brain they now suspect may control addictive behavior.

In testimony before the panel, Dr. Mark Molliver of Johns Hopkins University in Baltimore said tests on laboratory rats showed that ibogaine destroyed 10 percent to 15 percent of Purkinje brain cells -- large cells in the cerebellum, the region of the brain that controls balance and movement.

Dr. Molliver said researchers had not determined whether the destruction of the cells was a toxic side effect or was responsible for breaking the addiction.

The potential for brain damage in humans has discouraged pharmaceutical companies from developing the drug and was the primary reason some of the panelists and FDA consultants were reluctant to endorse human testing.

"It scares me that we're thinking about saying to a patient, 'We're going to be damaging 10 percent to 15 percent of the cells of the cerebellum,' " said Dr. Theodore Cicero of Washington University in St. Louis, a non-voting consultant to the FDA. "I don't think I could, in good conscience, participate in any study with humans."

But other panelists and consultants argued that addicts who may be helped by ibogaine already were engaging in dangerous behavior.

"These people, many of them are going to be dead if we study and study and study," said Cheri S. Groesbeck, a member of the FDA panel.

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