Rushing Drugs To Market
The pharmaceutical industry is continually discovering and developing new drugs that hold the promise of enhancing - even saving - many lives.
With that promise comes great pressure on the government to approve the drugs, even before all potential side-effects are known. CBS News' Sharyl Attkisson reports.
Monica George was an active, doting grandmother. Even diabetes didn't slow her down. But when her doctor prescribed the new drug 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.
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.
| When The Cure Is Fatal Review in more detail Monica George's case. |
What George didn't know was there was already evidence that Rezulin could kill. It had just been pulled off the market in Great Britain, and it was about to ignite a controversy in the United States over whether it reached the market too quickly.
In recent years, the Food and Drug Administration has been under a mandate from Congress 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. Rezulin is still used by a half million diabetics.
"No shots, no shots at all; I'm very happy, very pleased about that," declares Angeline Sathyasheelappa.
But Rezulin has also been linked to dozens of deaths, and Dr. John Gueriguian blames its quick approval. 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 late 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.
The FDA would not be interviewed for this report and won't readily reveal how many patients have been hurt by Rezulin. A year ago the FDA's chief epidemiologist said the number of liver failures likely numbered 400.
Dozens of those liver failures ended in death. Now labeling changes require much stricter monitoring of patients' liver function. But for some, the changes were too late.
"Here was a drug that there was a lot of doubt about safety issues, and it was marketed. I'm just incredibly angry,"Shaw says.
George's family knows Rezulin killed her and wonders how the FDA balances benefit and risk.