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...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...
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...
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...
...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...