Fear Mongering At The FDA

First, let's get this straight: There's no new evidence that naproxen, the active ingredient in over-the-counter Aleve and prescription Naprosyn, causes an increase in heart attacks. There is, however, strong evidence that the U.S. Food and Drug Administration did the drug industry equivalent of yelling, "Fire!" in a crowded theater. On Monday, the FDA turned a halted clinical trial into a very scary warning about Aleve. As reported here on Tuesday morning, there was no reason for a warning, and, in fact, naproxen might well be safe.

The National Institutes of Health announced Monday that it had halted a clinical trial testing whether naproxen and Celebrex, an arthritis pill made by Pfizer, might prevent Alzheimer's disease. Another NIH study testing Celebrex as a cancer preventative had found that the drug increased the risk of heart attacks, and patients were dropping out of the Alzheimer's study in droves. Because of the worries about Celebrex and the problems holding onto patients, the Alzheimer's study was halted. In the Alzheimer's study, though, there was no increase in heart risk for long-term Celebrex users. There was a slight increase in heart risk for naproxen users, but the increase was so small that it may have been a chance occurrence. It was not the kind of data on which decisions involving many thousands of patients should have been made.

The FDA apparently didn't see it that way. In its statement, it said, "Preliminary information from the study showed some evidence of increased risk of cardiovascular events, when compared to placebo, to patients taking naproxen." Then it warned patients to use Aleve only according to the directions on the label--sensible advice, but ominous given the circumstances.

None of this would have sounded so scary if it weren't for Merck's recall of Vioxx, the biggest-selling drug ever to be pulled from the market. Vioxx works by inhibiting the same enzyme as Celebrex. When results emerged showing Vioxx doubled the risk of heart attack and stroke, scientists had been presenting clinical and theoretical arguments as to why Vioxx might cause heart problems for three years. No such wellspring of criticism exists with naproxen, which is marketed by Bayer as Aleve....

Even if it had been statistically significant--that is, not due to chance--the heart risk with naproxen was only about 50%, according to the NIH. In contrast, the negative results for Vioxx and Celebrex showed a doubling or tripling of risk--about the same increase in cardiovascular risk as with obesity or smoking.

More here

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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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