FDA Advisers OK Human Testing Of Ibogaine

Copyright 1993 The Times Mirror Company
Los Angeles Times

August 26, 1993, Thursday, Home Edition
Correction Appended

LANGUAGE: ENGLISH

LOAD-DATE-MDC: August 27, 1993

SECTION: Part A; Page 15; Column 1; National Desk

LENGTH: 637 words

HEADLINE: FDA ADVISERS OK HUMAN TESTING OF HALLUCINOGEN;
HEALTH: SUPPORTERS SAY IBOGAINE MAY HELP SOME DRUG USERS OVERCOME THEIR
ADDICTIONS. OTHERS WORRY ABOUT POTENTIAL BRAIN DAMAGE.

BYLINE: By GREG MILLER, TIMES STAFF WRITER

DATELINE: WASHINGTON

BODY: A federal advisory panel recommended Wednesday that the Food and Drug Administration allow limited human testing of ibogaine, a potent hallucinogenic drug that is believed to help some heroin and cocaine users 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 proposal to the FDA.

The panel — the Drug Abuse Advisory Committee — asked that the researchers reduce the dosage from the levels originally proposed and requested that further experiments on 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 tests will be made by the FDA, which generally follows the recommendations of its advisory committees.

In making their case for the trials, 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.

Some researchers say they believe that the drug may curb addiction by damaging cells in the cerebellum, a region of the brain that controls balance and movement and may be linked to addictive behavior.

In testimony before the panel, Dr. Mark Molliver of Johns Hopkins University in Baltimore said that tests on laboratory rats showed that ibogaine destroyed 10% to 15% of Purkinje brain cells, which are large cells in the cerebellum.

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

The potential for brain damage in humans has discouraged pharmaceutical companies from developing the drug. It was also the primary reason some 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% to 15% 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 drug addicts who may be helped by ibogaine are already engaging in dangerous behavior and that the opportunity to break their addictions may be worth the accompanying risks.

“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 panel.

AIDS activist groups have argued that ibogaine, by combatting addiction, presents an opportunity to reduce the number of HIV infections caused by sharing dirty drug needles.

Attending Wednesday’s meeting of the advisory panel was Howard Lotsof, a New York businessman who said he discovered the drug’s addiction-breaking effects during the early 1960s while he was a heroin addict. He said he tried ibogaine and found, after a harrowing hallucination that lasted more than a day, that his craving for heroin had disappeared.

During a debate in which some committee members expressed their reservations about the drug, Lotsof, stepping outside the hotel ballroom where the meeting was conducted, said the panelists “just don’t understand” the desperation of cocaine and heroin addicts.

Lotsof, who said he hopes to market the drug, claims that he knows 30 subjects who tried the drug in the Netherlands and that most of them broke their addictions, at least temporarily, after just one dose.

CORRECTION-DATE: August 28, 1993, Saturday, Home Edition

CORRECTION: FOR THE RECORD

Test of Hallucinogen — A story on the drug ibogaine that appeared in Thursday’s editions referred to a study of its effects on mice and reported that treatments with ibogaine led to damage of 10% to 15% of the Purkinje brain cells in the mice. It should have been added that this estimate of cell damage reflected dosage levels four to 10 times higher than the anticipated human dose. Damage is less at lower dosages.

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