J. Scott Applewhite/AP
FDA Commissioner Andrew von

FDA Says Drugs Need to Do More—Save Lives

July 01, 2008 09:46 AM
by Cara McDonough
New standards for diabetes and cholesterol drugs could mean pharmaceutical companies will be spending a lot more money and time before approving new products.

30-Second Summary

The Food and Drug Administration is researching whether moving away from measuring traditional benchmarks—like lowering blood sugar and bad cholesterol—may make drugs more effective overall.

At a special meeting that began Tuesday, FDA officials and other medical experts will discuss whether pharmaceutical companies “should require additional, more rigorous benchmarks,” for diabetes drugs, “such as proof a drug ultimately lowers risks for cardiovascular disease, the leading killer of diabetics.”

Currently, companies need to prove only that the drug regulates blood sugar levels. But two major recent studies show that even aggressively lowering patients’ blood sugar levels doesn’t prevent them from having heart attacks.

The idea may affect cholesterol drugs, as well.

A recent trial of the Merck drug Vytorin showed that it does lower bad cholesterol, as the pharmaceuticals claim, but it does not necessarily save lives.

Higher standards may be a welcome change. The recent, sudden death of “Meet the Press” host Tim Russert, who was on cholesterol drugs and was exercising regularly but had a heart attack anyway, left many people worried about their own risk factors.

But new standards, which would include longer-term trials, also have some in the health care industry worried that pharmaceutical companies will simply stop developing these types of drugs.

“If you start putting a greater emphasis on doing [testing] premarket, you greatly increase the cost of clinical trials, which may lead companies to rethink developing new drugs in this area,” said Alan Goldhammer, deputy vice president at Pharmaceutical Research and Manufacturers of America.

Headline Links: Diabetes, cholesterol drugs may face stricter rules

Related Topics: Tim Russert’s sudden heart attack; diabetes cases increasing

Reference: Cardiovascular disease; diabetes


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