FDA panel says no to over-the-counter statin drugs; will the recommendation stand?

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Merck and Johnson & Johnson are working hard to make statin drugs available without a prescription. The thought is downright horrifying to those who know the true dangers of statin drugs -- muscle wasting, brain fog, even the risk of birth defects -- but it's just "business as usual" at Big Pharma. The pharmaceutical industry has been selling so many dangerous drugs to so many people for so long, that adding another over-the-counter medication to the mix didn't seem like such a big deal, apparently.

After all, NSAIDs (pain killers) are sold as over-the-counter drugs, and new research has shown that NSAIDs cause intestinal damage in as many as 70% of all users, outright killing an estimated 16,500 Americans each year from gastrointestinal bleeding. What's another few thousand deaths from statin drugs, after all? We're talking PROFITS here! Gotta keep those shareholders happy!

Fortunately, a moment of sanity has mysteriously emerged at the Food and Drug Administration, whose advisory panel has voted against allowing statin drugs to be sold without a prescription. Where did this sanity come from? Probably from all the recent drug scandals in which the FDA has been caught with its pants around its ankles... the Vioxx scandal, namely. Plus, there's the FOIA document that surfaced, showing that two-thirds of the FDA's own scientists don't think the agency can protect the safety of Americans, and nearly 1/5th of FDA scientists say they have been pressured to approve a drug they thought was unsafe.

In light of the recent drug safety scrutiny, the FDA is treading lightly. But don't worry, as soon as all this scrutiny blows over, they'll get right back to rubber-stamping dangerous drugs and padding the profits of Big Pharma. That is, if serious FDA reform doesn't dismantle the agency first.

Keep in mind that Merck and J&J can just reapply again next year. And the year after. And technically, the FDA doesn't have to listen to the advisory panel in the first place. They can just stamp "Approved!" on the drug, regardless of what the panel recommendations are.

But for today, consumers are just a little bit safer with statin drugs not being allowed as over-the-counter medications. Whether we actually have the FDA to thank for this is difficult to tell. Frankly, Dr. David Graham deserves most of the thanks here: without his warnings, the FDA wouldn't be under such scrutiny in the first place, and the OTC application for these statin drugs probably would have sailed through without a peep.

After all, NSAIDs are still legal, and they kill five times as many people each year as all the terrorist-related deaths ever recorded on American soil. If NSAIDs were, say, a Chinese herb, they would have been banned long ago, and armed FDA agents would have raided all the stores carrying inventory in order to "protect Americans." But NSAIDs remain legal for one reason only: they're profitable.

As I've said before, if all the people who died from over-the-counter drugs in America were to rise from their graves and march on Washington, the demand for change would be unstoppable. But dead people don't march, and they can't tell you, "Oh by the way, I was actually killed by over-the-counter drugs."

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