FDA SHOULD STICK TO MONITORING SAFETY

They might get it right if they did

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to increased risks of heart attacks and strokes - the same issues that caused Vioxx, a drug in the same class, to be withdrawn.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.


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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation.

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