Before writing a prescription, a physician always needs to ask: Is the treatment worse than the disease? To answer the question, the doctor needs to understand what the treatment entails and its worst potential side effects.

There is always the risk that the doctor will come up with the wrong answer. But is government intervention the solution or is the prescription in itself riskier than allowing physicians to follow their own best judgment, fallible though it may be?I agree that unproved treatment can cause harm, both directly and indirectly. But so can approved therapy. And so can the lack of treatment due to bureaucratic logjams.

If we are concerned about indirect effects, we need to look at the record of the U.S. Food and Drug Administration and other government bureaucracies.

In 1962, Congress mandated that new drugs had to meet government criteria for efficacy as well as safety before they could be marketed. The result: In 1965, it took approximately two years to gain FDA approval for a new drug, and the cost was about $4 million.

At the present time, it takes more than 10 years and costs about $231 million.

It is possible that the delay in the approval of propranolol, a drug that can prolong life in patients with heart disease, allowed 30,000 preventable deaths.

Other costs cannot be calculated. How many new discoveries will not be made because research money is diverted to meet bureaucratic requirements? How many promising treatments will never get to market because the potential profits will never be great enough to justify the cost of obtaining approval?

Vitamins, nutritional therapies and old, non-patentable drugs for new problems will likely all fall into this category.

Can one stop the inherent tendency of governments to expand their power? The FDA was instituted to protect the public against adulterated and harmful products. Then its role was expanded to define efficacy. Now it is attempting to redefine the term "drug" to include dietary treatments. It also micromanages what manufacturers are allowed to say even about approved substances.

For example, one company was forbidden to suggest that its product could be administered through a drinking straw, even though the FDA had approved of its use through a feeding tube.

Bureaucracies do not punish officials for erring on the side of caution, only for making mistakes in the opposite direction. Bureaucracies are designed to obstruct, not to expedite and certainly not to innovate.

Desperate people are willing to try desperate remedies. Preyed upon by unscrupulous entrepreneurs, patients who are seriously ill might make foolish choices. They might waste their money, forego more beneficial treatments and even do themselves harm.

Is there any way of reducing the risk of ill-informed patient decisions, aside from massive and often ill-informed regulatory intrusion?

There are numerous possibilities:

- Lawsuits filed by plaintiff's lawyers,

- Laws against the use of force or fraud,

- Educational efforts by groups like the American Council on Science and Health,

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- Required courses in public school on basic statistics and the assessment of propaganda,

- Free competition. Did anybody ever buy Laetrile or Krebiozen in preference to penicillin for the treatment of strep throat? The free market already has driven out most quack remedies for conditions that have a good accepted treatment.

Will the methods of freedom work perfectly in every case? No. Should we, therefore, call in the regulators to enmesh every product with a potential medical use in the regulatory morass?

I say that this prescription is far worse than the disease.

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