AP - Report: FDA Reviewer Removed
Sunday December 6 5:33 PM ET
LOS ANGELES (AP) - A veteran medical officer who opposed approval of a popular diabetes drug was removed as its chief reviewer by the Food and Drug Administration, the Los Angeles Times reported Sunday.
Two other FDA officials who recommended approving the drug, Rezulin, conceded the agency initially overlooked compelling evidence of its danger to the liver, the newspaper said.
Rezulin is used to treat adult-onset diabetes and is used by more than 1 million people. The drug has been linked to at least 26 deaths worldwide.
The FDA approved Rezulin in December 1996 to become the most quickly endorsed diabetes pill in the agency's 60-year history. Because Rezulin was the first in a new class of diabetes drugs, the FDA gave it a special ''fast-track'' review, taking six months to make the decision - less than half the normal approval time.
In October 1997, it issued the first warning about liver toxicity.
Britain withdrew the drug following the first reported deaths. The FDA said Rezulin remains on the U.S. market because it is the only diabetes drug that resensitizes the body to insulin - a hormone that
converts blood sugar into energy. Rezulin helps lower blood sugar enough that many patients report needing fewer daily injections of insulin.
The FDA recommends that Rezulin patients have regular blood testing in hopes of detecting early liver damage before it becomes life-threatening.
''We have been evaluating this drug very carefully since we became aware that liver disease was a significant problem,'' said Dr. James M. Bilstad, the senior FDA official who gave final approval to
Rezulin. ''We have in the past and continue up to this time to conclude that we still believe the benefits outweigh the risks.''
Dr. John L. Gueriguian, a veteran FDA medical officer assigned to evaluate Rezulin, recommended rejecting the drug after documenting its possible danger to the liver. Senior FDA officials removed him from the review in the late fall of 1996, according to Gueriguian and an agency memo.
Gueriguian, now a drug industry consultant, said he stands by his review. ''If (Rezulin) hadn't have been approved, at least 21 people would be alive now. In all probability, many more than that,'' he
said.
Two other doctors, Robert I. Misbin and G. Alexander Fleming, warned the FDA about possible serious side effects. Fleming said he suggested restricting the recommended use of Rezulin but relented following resistance from Warner-Lambert Co. (NYSE:WLA - news), the drug's
manufacturer.
''I said to myself, 'At this very moment as I am writing this, there are 2,000 patients that are going to die of this drug, unless we do something,''' Misbin told the Times.
''We believe this drug brings a unique and significant benefit for patients,'' said Dr. Randall W. Whitcomb, Warner Lambert's vice president for diabetes research. ''And while it has a risk, (this) is true of all medications.''
Gueriguian and the company said they had one meeting in which the doctor voiced doubts about Rezulin in intemperate language. After the company complained, the FDA removed Gueriguian from reviews of Rezulin and any other Warner-Lambert drug, the Times said. Warner-Lambert said it objected to Gueriguian's inappropriate comments, not his concerns about Rezulin. |
