Some Drugs Approved Too Soon

Irish actor Cillian Murphy poses for a photograph following an interview on his new film "The Wind That Shakes the Barley," outside a hotel at the 59th International film festival in Cannes, southern France, on Thursday, May 18, 2006. (AP Photo/Jeff Christensen)
AP Photo/Jeff Christensen
They hit the market faster but they also can make patients sicker.

Correspondent Sharyl Attkisson reports in part two of the CBS News investigation into new drugs hitting the market through a speeded-up approval process.

When David Storey's doctor gave him a new drug, Duract, to relieve his chronic back pain, he ended up with a much more serious problem: liver failure.

After Duract was blamed for at least eight liver transplants and four deaths, it was pulled from the market.

"I don't know about the FDA, I don't know how they work, but if they're there to prevent the drug companies from doing this, then somebody's not doing their job somewhere," says Storey.

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Duract was one of four medications withdrawn in a single year that were approved over the objections of the FDA's own medical reviewers, according to Dr. Sidney Wolfe, a longtime FDA critic with the consumer group Public Citizen. The other three were Pondimin, Redux and Posicor.

"In every instance, people with the Food and Drug Administration knew that it was wrong, who said the drugs shouldn't be approved, but were overruled," says Wolfe.

For decades, patient groups and the drug industry complained the FDA was far too plodding in approving new drugs. In the 1990s, Congress pushed to speed things up. The changes give the pharmaceutical companies more influence in the approval process. They even help pay the salaries of FDA drug reviewers.

Now, more drugs are hitting the market faster. The time it takes for a new drug to be approved has dropped from three years to one. And where the FDA once averaged 23 new drugs each year, that number more than doubled in 1996 and is still well above average.

It is a bonanza for the pharmaceutical industry, which says the FDA is finally operating the way it should.

"The only thing that has really changed is that the FDA is more efficient than it was before," says Alan Holmer, president of the Pharmaceutical Research and Manufacturers Association.

But current and former drug reviewers complain the pressure to approve new drugs can outweigh all other concerns.

"People are guinea pigs when a drug is first approved," says Elizabeth Barbehenn, former FDA pharmacologist.

"Management was so determined to increase the speed and number of new drugs being approved that they would not pay attention to what reviewers were saying," she added.

"I did notice the change, and in typical American manner, it was a pendulum shift from one extreme to the other," says Dr. John Gueriguian, former FDA medical reviewer.

The FDA would not be interviewed on camera, and refuses to readily release data on the numbers opeople hurt by various drugs. But the agency and the industry insist the system is the safest it's ever been.

"We think that when a drug is taken off the market, what that shows is the system is working," says Holmer.

Whether it's working or broken, there's no such thing as a risk-free pill. And Storey who now awaits a lifesaving liver transplant may be proof that the demand for new drugs and the critical need for safety can be a difficult balance to strike.