After months of internal debate, the Food and Drug Administration decided to pull the controversial diabetes drug Rezulin from pharmacy shelves after it received the latest data on two newer diabetes drugs, Avandia and Actos. CBS Correspondent Sharyl Attkisson reports.
Since our first report a month ago, the number of liver deaths linked to Rezulin has risen from 58 to 63. The FDA decided to pull Rezulin after it got the latest data on two newer diabetes drugs: Avandia and Actos.
"The data show that the potential for causing serious liver damage is greater with Rezulin than with the other two," says Dr. Murray Lumpkin, FDA Center for Drug Evaluation and Research.
With safer drugs available, the FDA said there's no longer any reason for patients to take Rezulin. Even though the drug's maker, Warner-Lambert, agreed to take it off the market, the company still insists Rezulin's benefits outweigh the risks. In a statement, the company said "repeated media reports sensationalizing the risks have created an environment in which patients and physicians are unable to make well-informed decisions."
But Rezulin's withdrawal comes months later than it should have, according to FDA scientist Dr. Robert Misbin and several of his colleagues who told CBS News. The FDA addressed the allegations from its own scientists.
"They feel that supervisors, you, the management were keeping it on the market and bowing to pressure from Warner-Lmabert Parke-Davis," says Lumpkin.
Asked about complaints by FDA scientists, Lumpkin said the allegations of a cover up were "just totally untrue."
"It is not uncommon at all here for us to have differences of opinion, have honest differences of scientific opinion," says Lumpkin.
Former FDA medical reviewer Dr. John Gueriguian was the first to clash with FDA management over Rezulin. It was approved over his objections. A symptom, he says, of a larger problem within the agency.
"There is something wrong in my humble opinion, about professional after professional medical officers at the FDA giving a recommendation and their recommendationa being overturned by people above them who are not really experts in this drug," says Gueriguian.
Up to now, the new drugs Avandia and Actors appear far safer, but the FDA says they haven't been out long enough for scientists to know for sure whether there will be serious problems in the long term.
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