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FDA BAN ON MENTIONING NEW USES FOR APPROVED DRUGS IS HARMFUL . . .

DOCTORS, RESEARCHERS AND pharmaceutical manufacturers have developed numerous pathways to disseminate information about novel uses of drugs.

Unfortunately, since 1991 the Food and Drug Administration has cracked down significantly on how drug companies can disseminate information on these uses.Manufacturers must get formal FDA approval, through a very long and costly process, for each specific approved use of a drug.

For example, it takes an average of nine years and $200 million for a phar-maceutical company to receive formal FDA approval for a drug to be used to treat a specific type of cancer. As often happens, doctors, hospitals and researchers later discover that the drug also is effective at treating other types of cancers. They then write up such uses in medical journals and other publications.

In the past, pharmaceutical companies routinely publicized the results of further research on their drugs after approval, thereby alerting physicians of other possible ways to save lives.

But in 1991 FDA Commissioner David Kessler prohibited pharmaceutical companies from informing doctors of new uses for approved drugs.

The FDA issued proposed regulations and - although the agency never finalized them - warned companies that they would face the agency's wrath if they violated the draft proposals.

The FDA claims that once a drug company does anything to distribute information on non-FDA approved uses of a drug, the drug becomes "misbranded."

It is still legal for doctors to prescribe drugs for off-label uses. However, it is far more difficult for them to learn of optimum dosages and treatment plans for those uses. The FDA's information ban is thus harmful to patients.

The FDA's restrictive new approach to promotions of drugs is especially hazardous to cancer patients. More than 1 million Americans are diagnosed with cancer each year, and the FDA's restrictive policies almost certainly result in more Americans dying from cancer.

The FDA's censorial policies also have resulted in more Americans having heart attacks and in more heart attack victims dying.

A 1988 study showed that the risk of heart attacks for males over 50 is cut in half by taking an aspirin each day. According to an article in the British Medical Journal, wider publicity of the "aspirin a day" preventive medicine practice could save 10,000 American lives each year. Yet the FDA has prohibited such notices.

Among the items being suppressed by the FDA's new policy are medical textbooks.

The FDA's enforcement efforts are intimidating textbook publishers, who now fear that including the latest information on drug use may result in the FDA's restricting sales of their books.

Another example of the impact of Kessler's new rules concerns the distribution of medical journal article reprints. Under the current FDA interpretation, it is a federal crime for a drug company salesman to give doctors reprints of medical journal articles that discuss off-label uses of one of the company's drugs.

The FDA prohibition of mentioning new uses for approved drugs effectively turns back the clock on the advancement of medical science.

The ultimate question is whether a policy of "better living through censorship" is good for the American people.