Cleaning Out the Medicine Chest

In 1962, Congress gave the U.S. Food and Drug Administration a franchise to rule on the efficacy as well as the safety of all new drugs offered for licensing. The lawmakers also invited the FDA to tackle a forbidding and involved cleanup job. From 1938 to 1962, some 7,000 new drugs had been marketed and during that period the FDA had final say on their safety but not their efficacy. The assignment from Capitol Hill was to recheck all of the drugs to determine whether they worked as advertised.

On the Shelves. Lacking the staff for that mammoth task, FDA called on the National Academy of Sciences-National Research Council for help. Through its Division of Medical Sciences, the NAS-NRC enlisted no fewer than 180 of the nation's top research physicians and divided them into 30 panels of six members each. It took five panels to sift the anti-infection agents alone. Dermatological drugs required another three panels, and drugs for the treatment of heart diseases two.

Although many drugs had disappeared from the market over the years through competitive attrition, the researchers found that they had to evaluate 4,000 dosage forms of 2,824 preparations containing 300 basic chemicals. Only 15% of the products were over-the-counter items; the rest were prescription drugs.

This month FDA released the panels' findings. The most striking conclusion was that about 7% of the products studied, or almost 300 drugs, are not effective for any of the uses suggested by the manufacturers in their advertising. Others are effective only for certain suggested uses. Since efficacy must be established beyond reasonable doubt under the 1962 law, the result of these findings will be to sweep scores of familiar products from druggists' shelves. Hundreds of others will have to be relabeled, with fewer, less provocative and appealing claims.

Pleasant Flavor. First to go from the drugstores, and already decertified by the FDA, are many of the "combination drugs," so called because they contain two antibiotics, or an antibiotic and one of the sulfa drugs. In all, 48 combinations, made by 19 different manufacturers (including eight of the biggest in the U.S.), were decertified. These 48 happen to be minor items in the prescription trade, so their makers are not likely to put up much of a fight for them. Some contain streptomycin, which may cause deafness, especially in children, and so should never be used unless it is the only drug that will kill the particular microbes involved. Others contain penicillin, which can cause a sensitivity shock reaction. The sulfa components are less risky, but can also cause dangerous reactions when not administered properly.

Explaining the agency's objection to any combination of antibacterial drugs, Commissioner Herbert L. Ley Ir. says: "The use of two or more active ingredients in treating any patient who can be cured by one is irrational. It exposes the patient to an unnecessary risk. Antibiotics should be used like a rifle, not like a shotgun."

Also under severe criticism from the experts, though not yet the targets for FDA regulatory action, are medicated mouthwashes. The panel on drugs used in dentistry found that mouthwashes are generally about as effective as a solution of common salt or even plain water. It suggested that the makers be required to drop claims that their products control breath odor, relieve throat pain or reduce the number of bacteria in the mouth. The washes should be allowed on the market, the panel said, only if they are advertised as "pleasantly flavored solutions."

Sales v. Safety. Panel after panel found that both manufacturers' claims for drugs and the doses prescribed by doctors are based largely on unquestioned assumptions. This is true not only of relatively new products, such as the cortisone group of hormones, but even of digitalis, the oldest and most effective medicine for the most common forms of heart disease. In most cases, the FDA will proceed slowly and cautiously, figuring that it may be wiser to leave a product on the market until its efficacy is definitely disproved by the panel.

In two cases in which FDA has taken decisive action, it has run into strong opposition. The agency is trying to remove from the market 1) a combination of two antibiotics, tetracycline and novobiocin, marketed by the Upjohn Co. as Panalba, and 2) a combination of tetracycline with an antifungal agent, sold as Mysteclin-F (E. R. Squibb & Sons), Declostatin (Lederle Laboratories) and Tetrastatin (J. B. Roerig division of Chas. Pfizer & Co. Inc.). Upjohn has already taken its case to the courts, and the other firms may do so as well. Both drugs are widely prescribed items, ringing up tens of millions in annual sales. Panalba and related formulations earned $23 million last year, almost one-sixth of Upjohn's total sales. With that much money at stake, the FDA will have to battle for what it believes to be patients' interests. Ley, who succeeded James L. ("Go-Go") Goddard as commissioner a year ago, has made it clear that he will not shrink from the fight.

In a recent speech, Ley warned the drugmakers: "I feel very strongly that you are in grave danger of losing public confidence. Unless there is a major change in the drug industry's emphasis on sales over safety, the industry as we know it today may well be buried in the next several years in a grave that it has helped to dig, inch by inch, overpromotion by overpromotion, bad drug by bad drug."

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