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FLEXIBILITY ON TESTING. The perfect trial has never been achieved," says the report. Thus, qualified professionals must be allowed to exercise more discretion in the investigational use of new drugs. Neither researcher believes that drugs should be cleared without testing merely because a few desperate patients with nothing to lose demand them. But both agree that "if a respectable minority of professional opinion believes in the utility of a drug, then it ought at least to be available to those who believe in it."
ACCEPTANCE OF FOREIGN TESTS. Many U.S. officials seem to feel that unless something has been done in the U.S., it is not worth doing at all. As a result, drugs that have been approved in foreign countries must often be tested anew before they can be marketed in the U.S. Such testing may be superfluous, contend the Rochester medics, especially if the testing has been done properly in the first place. Says their report: "If a drug has been shown unequivocally to work in one country, the fact that the drug has potential efficacy should be acceptable to all countries."
POST-MARKET MONITORING. U.S. drug policy currently emphasizes premarket testing of drugs. It would do better to pay more attention to what happens after a drug is cleared, say Wardell and Lasagna. "When widespread drug toxicity has occurred, it has only been after a drug has been marketed, and never in the early phases of development."
The recommendations of the Wardell and Lasagna report should please drug manufacturers and make sense to most doctors and pharmacologists. According to John Ballin, head of the American Medical Association's Department of Drugs, "There should be a streamlining of the process so a useful drug could get on the market quicker."
But the report has found few supporters at the FDA. The agency's current commissioner, Alexander Schmidt, concedes that there is a drug lag between the U.S. and other countries. But he denies that U.S. patients have suffered as a result. "There have been no significant therapeutic breakthroughs in other countries that this country has gone without," says he.
Schmidt, in fact, insists that the FDA can move quickly when it has to and will waste no time getting something like a proven anticancer drug or a more effective new antibiotic introduced in the U.S. But until such a product comes along, he will enforce his agency's standards, designed to be safe rather than fast.