More drug-safety questions increase doubts about FDA

 Is anyone watching the store?

Consumers ask that question when it appears that no one is accountable for how a business is being managed. It's a question many now ask about how the Food and Drug Administration (FDA) monitors drug safety.

On Friday, the maker of Celebrex announced that the pain reliever might be linked to increased risks of heart attacks and strokes — the same issues that caused Vioxx, a drug in the same class, to be withdrawn. More than a dozen of the world's most popular medicines have been challenged this year by new studies and scientists who say the FDA is failing to protect the public.

The stakes couldn't be higher. Vioxx alone may have caused more than 30,000 deaths, David Graham, an FDA whistleblower and safety expert, told Congress last month.

To be sure, all drugs carry risks. But how much trust can Americans have in the FDA when a government survey finds that two-thirds of its scientists lack confidence that the agency adequately monitors safety, and 18% say they'd been pressured to recommend a drug over their reservations?

The FDA's job is to make sure the benefits outweigh the risks and that physicians and patients are aware of both. But the agency often operates in the dark, particularly after a drug is approved, putting the public at risk. It has seven times the number of employees working on new-drug approvals than it does on safety issues after a drug is OK'd.

Potentially lifesaving new drugs ought to get fast review, but several changes in the system are needed:

Give FDA authority to demand targeted studies to resolve safety questions and funds to perform adequate research. Adverse effects of drugs may not be known for years. Yet the FDA waits for drugmakers to volunteer data instead of demanding that they track how drugs perform.

Create an independent drug-safety board. Critics say the FDA is too cozy with drugmakers and has a conflict of interest in monitoring safety. The attitude is that "they approved the drug, so there can't possibly be anything wrong with it," Graham says.

Bring stability to FDA leadership. The agency has had a permanent chief only 17 months of the past four years. The lack of stable leadership means the agency doesn't move as quickly and efficiently as it should.

The first step in a cure is acknowledging the problem. Instead, the FDA is in denial. Some strong medicine will be needed to regain public confidence.