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Drug 'Fast Track' Debated

Audrey Jones was taking part in a clinical trial of the new diabetes drug Rezulin when she became critically ill, reports CBS News Correspondent John Roberts.

"The doctor informed me that she was going to be put on the list for a liver transplant and she had to go into intensive care," says her husband Elmer.

Jones was one of 33 people to die from liver failure while taking Rezulin. That statistic has prompted calls to take the drug off the market.

The drug's manufacturer acknowledges there are problems. "The reality is that all medications have some risk. In this situation, we're fortunate with Rezulin to have substantial benefit as well," says Dr. Robert Zerbe of Park-Davis.

The FDA was aware that Rezulin could cause liver damage in about two percent of patients when it gave the drug "fast track" approval in January 1997.

But it was only after 35 reports of liver injury and one death that the FDA issued new recommendations for liver testing in patients on Rezulin. Just a month later, those guidelines were tightened further. This summer, the drug's manufacturer sent doctors even stricter recommendations.

Rezulin helps patients with type II diabetes, which develops in adulthood, to maintain lower levels of blood sugar. In some patients, it reduces the need for insulin.

Dr. Zachary Bloomgarden, who has received funds from the drug's maker, says that only 2 of the more than 100 patients he has treated with Rezulin had to stop using the drug.

"As long as Rezulin treatment is followed carefully by the doctor and the patient, its benefits clearly outweigh its risks," says Bloomgarden.

The controversy over Rezulin comes at a time when three new drugs have been pulled from the market and the popular impotence drug Viagra has been hit with new warning labels. That has raised questions as to whether an increase in public and industry pressure to approve new drugs has the FDA doing too much, too quickly.

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