FDA Drug Approvals: Speed Kills

It was hailed as a wonder drug, CBS News Correspondent John Roberts reports. A simple oral medication, Rezulin carried the promise of controlling adult diabetes without the inconvenience and danger of using insulin. But in the approval process -- and now, in three years of post-marketing surveillance -- Rezulin has proved to have dangers of its own.

In its latest assessment of adverse effects, the Food and Drug Administration reports that since it was approved in February 1997, there have been 85 cases of liver failure in patients taking Rezulin; 58 of those patients died, and 10 required liver transplants.

Over the past eight months, scientists at the FDA have begun to question whether Rezulin should stay on the market, particularly since two other drugs have been approved in recent months that have the same effect but not the safety concerns.

In an e-mail sent to his superiors on January 24, Dr. Robert Misbin, the Medical Officer in charge of Rezulin at the FDA said, "I see no reason why any well-informed physician would continue to prescribe Rezulin. Neither do I see any reason why FDA should delay in taking steps to remove Rezulin from the market."

The FDA has been under a mandate from Congress in the past few years to speed up new drug approvals. So instead of a process that used to take up to three years, the FDA approved Rezulin in less than a year on a fast track reserved for breakthrough drugs.

CBS News Correspondent Sharyl Attkisson reports Monica George was an active, doting grandmother. Even diabetes didn't slow her down. But when her doctor prescribed Rezulin to control the disease, she suddenly got sick.

"Her abdomen became incredibly swollen; she was laying in bed moaning, vomiting," says her daugher Elaine Shaw.

When The Cure Is Fatal

Seven agonizing weeks later, George died of liver failure, but not before learning her illness was linked to Rezulin.

"It was, like, 'Oh my gosh, here I took this drug for diabetes, to make my diabetes better. And this is what it did. You know...It's killing me!'" Shaw recalls.

What George didn't know was there was already evidence that Rezulin could kill. The drug was taken off the market in Britain two years ago, and U.S. watchdog organizations have also been calling for its removal. The FDA admits there are safety concerns, but notes the drug has been of benefit to thousands of patients.

According to Dr. Janet Woodcock, director of the FDA Drug Review Center: "The idea that there are safe drugs and unsafe drugs is not right. Every drug carries risk. And the real issue is when are its benefits outweighed by its risks."

Rezulin is still used by a half million diabetics.

Dr. John Gueriguian blames its quick approval on the dozens of deaths linked to Rezulin. He was the FDA's lead medical officer on the case.

"We're talking about an incredible number of events," he says. "Unfortunately, it is exactly as I predicted in ate 1996."

Gueriguian says the drug manufacturer, Warner-Lambert, and senior FDA officials ignored his warnings of possible liver damage in a rush to get the drug to market. He was removed from the case, and his colleagues quickly approved Rezulin.

Sources tell CBS News that there is now a feeling among several scientists at the FDA that the risks outweigh the benefits. Those sources also believe that by the time FDA officials meet with the drug's manufacturer on March 1, they will have decided to ask the company to withdraw Rezulin from the market.
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