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FDA, Botox and Making Faces

05/08/02 12:00AM By Cheryl Hanna
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When the pharmaceutical company Allergan announced that the Food and Drug Administration approved Botox for cosmetic purposes, I had a hard time keeping a straight face. And this, I'm told, is a problem.

Unless you were on that commercial shuttle to outer space the last few weeks, you've probably already heard about Botox. It's a form of botulism, which in high doses is so toxic that the Office of Homeland Security is worried that it could be used in a terrorist attack. But when injected in a diluted form, the toxin merely paralyzes your facial muscles so you can t crinkle your forehead or furrow your brow.

Now, a poker face can come in very handy if you're a professional poker player, or a politician. But Botox is most popular among youth-obsessed baby boomers. Because a face that can't frown, can't wrinkle. Although at $500 a hit every six months, I don't know why, if you could afford Botox, you'd have reason to frown in the first place.

But I'm not nearly as troubled by this latest escalation in the arms race for beauty as I am at how misleading news reports and drug companies can be about what FDA approval really means. The FDA never does its own studies, but relies on the pharmaceutical company to prove that its drug is safe and effective. Given that drugs like Botox are big money makers, many question whether industry science is really value-free.

It's true that the FDA approval process can be long and expensive, especially for those drugs used to treat life-threatening illnesses such as AIDS. But the FDA has also been known to quickly, and some say, irresponsibly, approve drugs and medical devices, especially those used to enhance beauty. Remember the scare over silicone breast implants? The FDA couldn't answer what would happen if the implants leaked because it never asked; in spite of the fact that it went ahead and approved them. Millions of women panicked and underwent removal surgery, which, it turns out, was probably unnecessary.

Then there was Redux, the FDA approved weigh loss drug. Many people suffered heart damage and died when doctors prescribed it in a super diet cocktail combination known as fen-phen, even though using Redux in combination with other drugs was never approved. That was possible because the FDA does not regulate the practice of medicine. Doctors can prescribe drugs for non-approved or "off-label use" without fear of FDA sanctions. And because Botox was approved in 1989 to treat eye spasms, more than a million people have already had injections - to erase wrinkles.

The bottom line is this: The FDA is only empowered to regulate the marketing of drugs. All its approval really means is that Allergan can now spend $50 million dollars to convince us to stop making faces. So, if someone ever implies that FDA approval means a drug is 100% safe and effective, and they so do with a straight face, ask them: what drug have you been injecting?

This is Cheryl Hanna, and I am making faces while I still can.

Cheryl Hanna is a professor at Vermont Law School in South Royalton, Vermont.
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