A duel of two press releases hit the science-writing media Monday.The first announcement, from Johns Hopkins Medical Institutions,reported: "Diet drug causes long-term damage in animal brains," and isembargoed until this evening, Tuesday, at 6 p.m. E.S.T. This coincideswith publication of the research Wednesday, May 11, in the Journal ofPharmacology and Experimental Therapeutics.The counter-statement, from Interneuron Pharmaceuticals Inc. (IPI) ofLexington, Mass., announces: "Interneuron criticizes dexfenfluraminepress release."Dexfenfluramine is an anti-obesity drug that stimulates release ofserotonin, a neurotransmitter that curbs appetite centers in the brain.(See BioWorld Today, May 25, 1993, p.1.) It is marketed byprescription in Europe, and awaits FDA approval in the U.S.IPI's press communiqu quotes the Johns Hopkins notice as reportingthat "very high doses of dexfenfluramine cause long-term nerve effectsin brains of squirrel monkeys." BioWorld will report the entire study intomorrow's issue, once the embargo is lifted.IPI's president and CEO, Glenn Cooper, stated, "The FDA is reviewinga New Drug Application (NDA) for dexfenfluramine, and is aware ofthese observations [in the Hopkins announcement]. That NDA contains18 double-blind, placebo-controlled studies involving more than 4,000patients in the U.S. and Europe, 600 in the U.S. alone."IPI's director of corporate communications, William Boni, toldBioWorld that his company considers the disclosure of this negativestudy "regrettable" while an FDA application is pending. He "wouldwelcome the examination of these findings," but said "that the bestsetting for such a review would be in an FDA advisory committee." Nosuch committee meeting, he added, is now scheduled.Boni declined to disclose the source from which he had obtained theembargoed press release.Over two years ago, Johns Hopkins researchers reported in The Lancet(Dec. 14, 1991) that dexfenfluramine damages certain nerve cells in thebrains of monkeys given the drug. At that time, Interneuron executivestold BioWorld (See Dec. 31, 1991, p. 1) that the findings had not beenaccepted by other scientists.
-- David N. Leff Science Editor
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