Protecting us from the good things?

Posted: Jun 01, 2005 12:00 AM

It's natural to fear freedom. Tell most Americans that we'd be better off if we clear-cut the regulatory jungle and simply let the market decide what products are sold, and you're likely to be told how dangerous the world would be. Most people think government keeps us safe. It's why the Food and Drug Administration (FDA) is regarded as absolutely necessary. It protects us from snake-oil sellers. Who could argue with that?

 I will, because years of consumer reporting have taught me that the regulators, by protecting us from bad things, protect us from good things, too. When we let the government use force to limit our choices, we deprive ourselves of innovation that makes life better. Even genuinely compassionate officials can literally regulate us to death.

 In 1962, the FDA didn't let American women take the tranquilizer Thalidomide, while in Europe, women who took it sometimes gave birth to children with no arms or legs. The Thalidomide tragedy is cited as an example of how useful the FDA is, and we're all glad American babies were protected.

 But after the Thalidomide success, the FDA grew like a malignant tumor. Getting a new drug approved now takes 12 to 15 years. It takes that long because the FDA wants to be extra sure every drug is safe and effective. That seems reasonable. But this vigilant pursuit of safety also kills people.

 Some years ago, the FDA held a news conference and proudly announced, "This new heart drug we're approving will save 14,000 American lives a year!" No one stood up at the press conference to ask, "Doesn't this mean you killed 14,000 people last year -- and the year before -- by keeping it off the market?" Reporters don't think that way, but the FDA's announcement did mean that. Thousands will die this year while other therapies wait for approval.

 You may want to wait. Many of us want to be absolutely sure a drug is safe before we take it. It's natural to want the "experts" to protect us. But why isn't the choice left to us? Why does the FDA get to force us to wait and, in some cases, die, when there are experimental drugs, however risky, that might save our lives?

 I interviewed Janet Cheadle, a young girl suffering from a form of cancer that, left untreated, would kill her before she grew up. Her parents wanted to take her to a doctor who claimed he had a treatment that might help her. But the FDA ruled that Janet was not allowed to pursue his treatment because the FDA hadn't sanctioned it. Maybe the wiser move was not to try the treatment. But shouldn't that have been Janet's choice?  She was dying. It was her body and her life. Shouldn't she have been allowed to experiment if that was what she and her parents wanted? Ultimately, she was allowed -- but only after her father testified before Congress.

 Thousands of Americans die prematurely because they are too fat. Drug companies have invented fat substitutes -- ingredients that taste as good as fat but are not absorbed by your body. This would help the obese, but they are not permitted to try them, because the ingredients are still squeezing through the FDA's 12-to-15-year pipeline. After all, there's a tiny chance that something in these innovative products might hurt us.

 But what about the thousands of lives that would be saved? Don't those lives count?


 The bureaucrats and reporters focus on the victims of innovation. The fen-phen deaths were on the front pages of most every newspaper. We put Thalidomide babies on magazine covers. But what is not seen often matters more. The fat substitute or the new heart drug might save thousands. But whom would I photograph? We don't know which of us might be saved.

 Am I suggesting we just junk the FDA and let the market take over? That sounds chaotic and threatening, and it's not about to happen. But there is a better way. That's next week's column.