IT’S MY LIFE

Ninety-five percent of anything is crap.


STURGEON’S LAW

You cannot buy certified raw milk in Illinois. Raw milk is milk that has not been pasteurized; certified raw milk is raw milk produced under such scrupulously sanitary conditions that its bacteria count is lower than that of pasteurized milk. Heating milk to pasteurize it denatures the protein and destroys some vitamins and enzymes; some nutritionists argue that pasteurization drastically lowers milk’s nutritional value and that raw milk, provided it is sanitary, is much superior to pasteurized milk. It is also, in Illinois, illegal.

There are a number of chemicals that some nutritionists believe are necessary to nutrition in much the same way that recognized vitamins are necessary. Choline and inositol, for instance, are thought to be involved in metabolizing cholesterol and thus protecting against hardening of the arteries and heart attacks.

According to the label on my bottle of choline, “the need for choline in human nutrition has not been established.” According to the label on my bottle of inositol, “the need for inositol in human nutrition has not been established.” I doubt that the manufacturer regards this as good advertising, especially since the labels contain no balancing statement about the evidence that choline and inositol may be useful to human nutrition. Uniform labeling is a federal requirement. It is apparently illegal for the producers to tell me why they think their product is worth buying.

Both federal regulation of labeling and state laws against raw milk are government interventions in an ongoing controversy between two groups of experts, nutritionists and doctors. The nutritionists argue that many apparently medical problems are at least partly caused by inadequate nutrition; the doctors argue that, with a few well-understood exceptions, a proper diet without any special health foods or vitamin supplements provides adequate nutrition. The argument is long and involved; to those who wish to examine the nutritionists’ side, I recommend Food Facts and Fallacies by Carlton Fredericks and Herbert Bailey. My own opinion, based on a very limited examination of the literature, is that the nutritionists have a case. The accepted lists of minimum daily requirements are overly conservative in both number of nutrients listed and amounts suggested. Some of the additional nutrients may turn out, in the long run, to be worthless, but taking them is worth the gamble.

Why do many doctors and their official representative, the AMA, take the opposite position? Partly, perhaps, from economic self-interest; the nutritionists, after all, are competing with them in the business of making people well. But more, I suspect, because the doctors, having been trained in one way of making people healthy, are suspicious of any others and regard the nutritionists as incompetent practitioners of medicine, quacks.

Some of them are. Any health food store with a bookrack will yield a colorful collection of tracts on how to live to one hundred on yogurt and bulgur wheat. The health food business is not exempt from Sturgeon’s law. Neither is the doctor business nor the regulation business. No bureaucrat is eager to offend a powerful and respected interest group. Regulation is naturally biased in favor of the ins against the outs, the orthodox against the radical—in this case, the doctors and the AMA against the nutritionists. The orthodox side is able to give its position the force of law, to forbid manufacturers from stating arguments that the government and the AMA do not accept or to forbid individual consumers from buying a product that in their judgment isn’t good for them.

This is a bias not for doctors and against manufacturers or for experts and against the uninformed but simply for old against new. The Food and Drug Administration (FDA) does not keep the food industry from labeling its breads and flours as ‘enriched’, even if, as many argue, more has been taken out than put back. The food industry is an established, respectable interest. It is only people with new and unpopular ideas who are likely to be labeled quacks or crackpots and treated accordingly.

The same problem occurs in government regulation of pharmaceuticals. Here the FDA does not limit itself to censoring labels; it has the power to give or withhold permission to market medical drugs. Almost everyone approves of this power. The danger of an irresponsible producer releasing a new product prematurely only to discover tragic side effects is obvious. What is more natural than to have the government prevent such lethal gambles by keeping new drugs off the market until they are proven harmless? Why not play safe?

But there is no way to play safe. If a useful new drug is kept off the market, people who might be saved if the drug were available will die. Caution kills. Whom it kills may not be obvious; often the new drug is only an improvement on an old one, an improvement which might raise a cure rate from 80 percent to 85 percent. Which men and women and children make up the 5 percent killed by caution no one can ever know; their deaths are statistics, not headlines. A statistical corpse is just as real as a thalidomide baby on the front page; it is just less visible.

Visibility is an important element in politics and the FDA is a political institution. Given a choice between one tragedy on the front page and ten in the medical statistics, it inevitably prefers the latter. It thus has a strong bias in favor of overregulating, of stifling medical progress in the name of caution.

Drug companies have some of the same bias. Corpses on the front page are bad advertising. Damage suits can be expensive. But drug companies are also in the business of selling drugs to people who very much want to live; a new and improved product is a new source of income. The drug companies are, to some degree, in a position to balance the risk of tragedy against the value of a better chance at life to people who want to live it.

My own conclusion, that drug companies should be free to sell, and their customers to buy, anything, subject to liability for damages caused by misrepresentation, must seem monstrous to many people. Certainly it means accepting the near certainty of a few people a year dying from unexpected side effects of new drugs.

I believe the cost of our present policy, although less visible, is even higher. How high I cannot tell. I know that at least one doctor associated with the development of cortisone believes it would not now be available if the FDA had at that time enforced as stringent safety standards as it does now. The same has been said—upon how much evidence I do not know—of penicillin. There will doubtless be people who gamble their lives on the use of new and unsafe drugs and lose. Against that we must set the lives of the millions who would be dead today if we had played safe 50 years ago.

[The argument of this chapter received striking support in 1981 when the FDA published a press release confessing to mass murder. That was not, of course, the way in which it was worded; it was simply an announcement that the FDA had approved the use of timolol, a beta blocker, to prevent recurrences of heart attacks. At the time timolol was approved for that use, beta blockers had been widely used outside the U.S. for over ten years.

The FDA estimated that the use of timolol would save from seven thousand to ten thousand lives a year in the U.S. If so, its failure to approve the use of beta blockers before l981 was responsible for something close to a hundred thousand unnecessary deaths.]

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