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Report: FDA Removes Medical Officer

December 7, 1998

LOS ANGELES (AP) _ The Food and Drug Administration removed a veteran medical officer as the chief reviewer of a diabetes drug linked to liver problems after he had opposed its approval, the Los Angeles Times reported.

Dr. John L. Gueriguian, the FDA officer assigned to evaluate the drug, Rezulin, recommended rejecting the drug after documenting its possible danger to the liver, the newspaper said Sunday.

The drug, made by Warner-Lambert Co., is used by more than 1 million people to treat adult-onset diabetes. It has been linked to at least 33 deaths in the United States and Japan.

Rezulin was the first in a new class of diabetes drugs, and the FDA gave it a special ``fast-track″ review. It was approved in December 1996. By October 1997, the FDA had issued the first warning about liver toxicity.

Senior FDA officials removed Gueriguian from the review in the late fall of 1996, according to Gueriguian and an agency memo.

Gueriguian and Warner-Lambert 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.

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. 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 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, now a drug industry consultant, said he stands by his original 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.

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