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Holes in U.S. Drug Safety Net

Consumer Reports: Drug Approval, Follow-Up 'Flawed'
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Drug Industry Reaction continued...

And Trewhitt notes that fewer than 3% of drugs are withdrawn from the market due to safety concerns -- a rate that hasn't changed since PDUFA took effect.

Laurence B. Gardner, MD, chairman of the department of medicine at the University of Miami Miller School of Medicine, agrees with most of the points made by the Consumer Reports article. But he says the FDA's preapproval process isn't the problem.

"Consumer Reports implies that people at the FDA rush approvals through and don't look at safety data," Gardner tells WebMD. "But we are still the safest country in the world when it comes to drug approval. That being said, there are a lot of issues with our health care system. And current regulations don't protect the consumer."

After Drug Approval: Patient Beware

When the FDA approves a drug, it sometimes asks the manufacturer to conduct further safety studies. Consumer Reports notes that in February 2005, companies agreed to 1,191 such studies. Yet as of September 2005, more than two-thirds of the studies were still "pending."

The most important drug-safety experiment comes in the years following drug approval. The subjects of this study: consumers who take the drug.

Preapproval studies enroll no more than a few thousand people -- usually healthier people than many of those who will take the drug after approval. And the studies usually last only a few months. Rare side effects, problems for people with multiple conditions taking multiple other drugs, and long-term side effects can only be seen in the years following approval.

And that, Lipman says, is where the U.S. system breaks down. Doctors are supposed to report any side effects that happen. But because there is no reliable system -- and, Gardner says, because these reports aren't easy to file -- only a small fraction of side effects actually get reported.

Compounding this problem, Lipman says, is direct-to-consumer advertising. Ads heavily promote new drugs. Yet there's a drug risk associated with every drug benefit. And the Consumer Reports article states the ads stress benefits but don't adequately identify risks. "It is impossible to monitor all the ads that are out there," Lipman says. "And more ludicrous, the ad goes into the media, and it takes FDA

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