Diabetes Drug Rezulin Pulled Off the Market

The Times reported that the FDA ignored explicit signs of danger while examining Rezulin in January 1997, after a six-month review, the fastest approval granted a diabetes pill.

Complaints About Intemperate Language

The FDA approved Rezulin despite a recommendation to reject the drug by a veteran agency medical officer, Dr. John L. Gueriguian, who cited its potential danger to the liver and the heart. Woodcock's deputy, Dr. Murray Lumpkin, stripped Gueriguian of his role in reviewing Rezulin in the fall of 1996, following complaints from Warner-Lambert about his use of intemperate language.

Reached Tuesday night at his home in Rockville, Md., Gueriguian said he was pleased to hear of Rezulin's withdrawal.

"It is the right thing to do. But it is too late. Too many people have already died and suffered."

Gueriguian stood alone when he opposed Rezulin in 1996. No fewer than four other FDA physicians who examined the drug endorsed its approval. They were persuaded, they said in hindsight, by Warner-Lambert's claims of safety and the pill's supposed breakthrough effectiveness.

Indeed, as recently as Feb. 24, Woodcock told reporters in a prepared statement that Rezulin "provides an effective treatment to control blood glucose and in many patients it has proven to be very effective despite the failure of other therapies."

At least three federal investigations related to Rezulin have been initiated: an inspector general's inquiry into a senior National Institutes of Health physician's acceptance of consulting fees from Warner-Lambert, an FDA inquiry into allegations that the company omitted findings of liver toxicity from a 1994 clinical trial and an FDA internal-affairs investigation into how certain agency e-mails came into the possession of The Times.

Company's Troubles Are Not Over

Having failed to hold support for Rezulin at the FDA, Warner-Lambert on Tuesday night issued this statement:

"The company has always believed that it is essential for patients and physicians to receive accurate and objective information regarding the benefits and risks of Rezulin. . . . However, repeated media reports sensationalizing the risks associated with Rezulin therapy have created an environment in which patients and physicians are simply unable to make well-informed decisions regarding the safety and efficacy of Rezulin."

The withdrawal, however, will not end the company's troubles. Over the last year, product-liability cases have been filed in state and federal courts on behalf of patients or their survivors.

One of them, Ismael "Milo" Valenzuela, whose wife, Rosa Delia Valenzuela, died in Los Angeles on Dec. 18, 1998, of liver failure after taking Rezulin, welcomed news of the withdrawal.

"That's the main thing I wanted to see, to get those pills off the market," said Valenzuela, a retired jockey who twice won the Kentucky Derby. "They killed my wife--that's the way I feel about it."

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Times researcher Janet Lundblad in Los Angeles contributed to this story.

A series of investigative reports on Rezulin is on The Times' Web site:

http://www.latimes.com/rezulin