Letters

Food und Drang Administration

As one who has objected to a number of FDA actions, I approve of much of Alexander Volokh's article ("Clinical Trials," May). I have little love for the FDA.

But I have less for drug manufacturers who, with the FDA's connivance, claim exclusive rights to products developed with our money and charge exorbitant prices for some when their own R&D has been recovered a hundredfold. In seeking to reduce regulations, I should not want us to throw the baby out with the bathwater.

I remember why federal regulation was needed in the first place. When I took high school chemistry, our professor had a glassed-in cabinet of tainted, corrupted, even poisonous canned products sold as food before federal regulation came in earnest with the passage of the Pure Food and Drug Act of 1906. (It was only in 1931 that the FDA itself was created.)

Throughout recorded history there have had to be laws regulating food (especially adulteration) and drugs; we cannot do away entirely with them now.

Ralph Mason Dreger, Ph.D.
Baton Rouge, LA

Many libertarian authors become confused between good guys and bad guys. Just because government is bad, it does not follow that industry is good. The Bureau of Health Statistics notes that 125,000 people died in 1992 from adverse reactions to prescribed drugs. Alexander Volokh's "statistical" claim of all the lives that could have been "saved" if the FDA had permitted the marketing of various drugs and devices does not ring true. I suppose what he means by a "life saved" is a few more months of suffering at the cost of hundreds of thousands of dollars to insurance customers.

I dislike the FDA as much as anyone, but please don't assume that the pharmaceutical industry (or any other industry for that matter) is an altruistic institution. Let the buyer beware.
Gordon LaBedz, M.D.
Los Angeles, CA

Alexander Volokh's article presents hard evidence that the FDA causes the deaths of thousands of Americans every year by holding up the approval of lifesaving medical drugs and devices. The article is an excellent indictment of the FDA, but it doesn't go far enough.

The book Drugs Available Abroad by Jerry L. Schlesser (Gale Research Inc., Detroit, 1991) lists more than 5,000 safe and effective drugs available in countries around the world, but not in the United States. Many of these drugs, such as the neurostimulators Centrophenoxine and Piracetam, have been used safely and successfully throughout the world for decades, but will never be approved in the United States because the companies selling them have no incentive to seek approval. The patents on such drugs have long since expired and their widespread use makes them poor candidates for the huge expenditure of money and time needed to apply for FDA approval. The Center for the Study of Drug Development at Tufts University in Boston has calculated that it costs a company an average of $230 million and 10 years to obtain FDA approval for a new drug. These kinds of costs make it impossible for all but the largest pharmaceutical companies to get FDA approval for new drugs.

The agency's discouragement of off-label uses of approved drugs (such as aspirin) also causes many deaths. Although doctors are free to use approved drugs for any use they think appropriate, companies cannot advertise these uses, and most doctors are hesitant to prescribe off-label uses because of their lack of knowledge about these uses and because of their fear of malpractice suits. And, while the FDA has a policy that Americans may import unapproved drugs from foreign countries for their personal use, the agency does everything in its power to prevent them from doing so. The FDA orders U.S. Customs to seize such products at our borders and tries to destroy companies in other countries that sell unapproved drugs to Americans.

The agency is also responsible for deaths from highly dangerous drugs approved by the FDA. Thomas J. Moore's recent book Deadly Medicine (Simon and Schuster, 1995) documents the needless deaths of hundreds of thousands of Americans from the use of a single class of anti-arrhythmic drugs. Moore shows that the FDA approved these drugs without a shred of evidence that they provide benefits for anyone and with hard evidence that they kill people. The FDA knew that these drugs were killing people by causing the very same arrhythmias they were supposed to prevent, but the agency approved them anyway on the theory that they might save more lives than they cost. This theory was obliterated by a controlled clinical trial directed by the National Heart, Lung, and Blood Institute, which found that patients taking the drugs died at least three times as frequently as patients on placebos.

Finally, the agency has caused enormous damage to the health of the American people through its policies regarding vitamins, minerals, and other nutrient supplements. Although there have been thousands of studies showing that nutrient supplements can help to prevent heart attacks, strokes, cancer, and other lethal diseases, the FDA prohibits companies selling these products from informing the public about these studies.

There is a simple solution to stop the carnage, initially proposed by Durk Pearson and Sandy Shaw: Just take away the FDA's power to stop Americans from using the products they wish to use by providing for a split label (including promotional literature). Half the label would be written by the company selling the product and half by the FDA. Anyone who wants FDA protection could stay away from unapproved products, while those who want freedom of choice could waive FDA protection whenever they wish to.

Such a change would force the FDA to compete for the consumer's ear. If the FDA gave consumers good advice based upon solid research, most health-conscious Americans would follow it; if the FDA's advice was bad and unsupported by evidence, most health-conscious Americans would ignore it.
Saul Kent
President
Life Extension Foundation
Ft. Lauderdale, FL

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