The Drug Lag

At the turn of the century, hucksters sold worm syrup and other nostrums to cure everything from rheumatism to cirrhosis. Back in 1908, the government succeeded in banning a headache remedy containing a toxic acid and bearing the beguiling name of Cuforhedake-Brane-Fude. The Food and Drug Administration, which was formally established in 1931, has stamped out such gross quackery. But now many concerned scientists are beginning to wonder whether the FDA has become so cautious in its repression of quack cures and unsafe medicines that it is in some danger of stamping out or at least slowing the development of new drugs. The latest report is by two pharmacologists from the University of Rochester School of Medicine and Dentistry. The current laws, argue Drs. William Wardell and Louis Lasagna in a new study titled Regulation and Drug Development, are so strict that they actually inhibit the development of new drugs. As a result, American patients are not only being deprived of drugs already in use in other countries, they are also paying more for those they can obtain at home.

A major part of the FDA's problem, say the Rochester researchers, is a set of 1962 amendments to the Food, Drug and Cosmetic Act--passed in response to the thalidomide disaster that produced thousands of deformed babies throughout Europe. These amendments, which aimed at assuring that drugs were effective, and earlier amendments setting standards for safety, were designed to prevent the introduction of any drugs that might be toxic or cause birth defects or cancer. But they have had other, less desirable effects as well.

The new regulations mean that drug manufacturers must conduct extensive --and expensive--studies in animals in order to obtain the "investigational new drug" permits, known as IND, that will allow them to administer their medications to humans in clinical tests. One result of these requirements is that the cost of introducing a new drug has climbed considerably, jumping from an average of $1.3 million in 1968 to $10.5 million today.

A more important result of these regulations has been to put the U.S., whose medical technology is the world's best, behind other countries, particularly Britain, in the development of new drugs. The Wardell-Lasagna study shows that of 180 new drugs introduced in the two countries in the decade beginning in 1962, a mere 21 were first made available only in the U.S. In fact, at the beginning of the decade, 77 drugs, including many that U.S. physicians now consider not only safe but effective (see box), were not authorized by the FDA for use in the U.S.

To combat this drug lag, Wardell and Lasagna urge several changes. Among them:

REALISTIC STANDARDS. The drug that is 100% safe at all dose levels has yet to be developed and probably never will be, say Wardell and Lasagna. Therefore, it is unreasonable to expect drug developers to prove that their product is totally without risk. Every drug represents a compromise between risks and potential benefits. Only when the risks clearly outweigh the benefits should a drug be forbidden.

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.

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