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Will Cholesterol Drugs Go Over the Counter Soon?

Are statin drugs safe enough to be over the counter? If you believe the medical experts nearly everyone should consume them. The Food and Drug Administration will soon be facing that question. A joint venture between Merck & Co. and Johnson & Johnson is planning to ask the FDA for permission to sell Mevacor, the oldest statin drug, over the counter. Bristol-Myers Squibb Co. may eventually do the same with its competing statin Pravachol, though it declines to talk about its plans beyond saying company officials are "continuing to evaluate our options." The FDA gave a verdict on over-the-counter statins in 2000: No. But now there are signs the agency is ready to reconsider the issue.

As I wrote in Saturday's issue, with at least 12 million Americans taking cholesterol-lowering drugs, mostly statins, and experts? recommendations that another 23 million should be taking them, it?s no wonder that the drug companies are scrambling to get their piece of the pie by releasing new and ?improved? statin drugs, and they now are working to bypass the doctor out of the equation and convince the consumer through direct advertising to sell their solutions. The real tragedy is that the real solution to high cholesterol involves normalizing insulin levels, not taking drugs.

Wall Street Journal November 11, 2003 (no link)

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