Just as Good?

"Aspirin is just plain aspirin and nothing else," says Wisconsin's Senator Gaylord Nelson. It is just that, he claims, regardless of how much it costs and whether it carries a famous brand name. Nelson goes further: he believes that prescription drugs for serious illnesses should be dispensed, not under a manufacturer's trademark name, but under the "generic" (common chemical) name, which usually carries a lower price tag. Whether generic and brand-name drugs are really medically equivalent has been debated before Nelson's Senate Monopoly Subcommittee for almost two months now. So far, no witness or Senator has been able to provide a flat answer--because none is possible. The example of two drugs, one prescription and one nonprescription, makes the point.

In the case of over-the-counter aspirin, even so crude a test device as the irritable stomach of a man with a hangover will sometimes show a distinction: two five-grain tablets of one brand, especially from a half-empty bottle that has been in the medicine chest for a cou ple of months, will promptly give him heartburn, whereas the same dose of another brand may have no such effect.

No Trace of Water. The first aspirin was made by Germany's Bayer company, and its U.S. descendant (a division of Sterling Drug Inc.) today charges six to ten times as much as no-name brands. To justify the difference, Bayer contrasts U.S.P.*minimum standards with its own. Before tableting, says U.S.P., the basic chemical must be in tabular or needlelike crystals or crystalline powder; to produce a dependable dissolving rate, Bayer requires a special flake shape and needle shape (slender, tapered at both ends). U.S.P. permits .5% moisture and weight loss on drying; Bayer will tolerate none. U.S.P. allows up to .1% free salicylic acid; Bayer holds to one-third of that, and halves three other U.S.P. permissible deviations from absolute purity. In the finished tablets, U.S.P. accepts 5% underweight for the active ingredient; Bayer none. U.S.P. permits .15% free salicylic acid; Bayer still holds to its own requirement of not more than .035%. Disintegration in water, says U.S.P., must be complete in five minutes; Bayer says begin in 2 seconds and be complete within 30 seconds.

To turn salicylic acid into acetylsalicylic acid (aspirin), a compound related to acetic acid is used. If the raw aspirin is then cleared of impurities by washing with water, any remaining water will react to create a minute quantity of acetic acid--vinegar. This accounts for the vinegary odor and some of the irritating effect of much fresh aspirin and of most old aspirin. So Bayer uses a more costly, water-free process.

406 Hours of Tests. Penicillin G, one of the most widely used forms of the supreme antibiotic, differs from aspirin in being a prescription item, but resembles it in being free of patent, royalty and basic-research costs. Yet here again there is a huge price spread: E. R. Squibb & Sons charges the druggist $6.62 for 100 tablets of 200,000 units, while Pennex Products Co. of Verona, Pa., sells the same number, same strength, for 920. And Pennex must meet not only U.S.P. standards, but the running check on all antibiotic batches maintained by two different Government agencies.

Squibb explains: U.S.P. standards call for 98 tests, consuming 125 hours, at eleven steps in the manufacture, while Squibb's quality control requires 374 tests, taking 406 hours, at 35 stages. Squibb runs a three-hour test on one of the alcohols used in manufacturing, another of 16 hours on corn-steep liquor, and one of 22 hours on city water. The U.S.P. requires none of these. Moreover, Squibb offers its penicillin G in twelve different strengths, dosages and combinations, some of which make no money, while most manufacturers of generic penicillin G make only the one or two most widely prescribed formulations, which are the moneymakers.

Some Do. There is no reason why producers of generic-name drugs cannot make them to the highest brand-name standards if they choose to invest the necessary time and money. Some, but not all of them, do so. Though several of the subcommittee's witnesses so far have tended to support the contention that generic-name drugs are potent and acceptable, they have also admitted that they cannot really sort out what is equal to what in the pullulating pill market. No one, it appears, has run a comprehensive test on an entire family of drugs, such as the cortisone-type hormones, which show fantastic price spreads, to see how they really compare in medical effectiveness. Not until laboratory experts agree on how to do that--and then do it--will it be possible to say which cheap drugs are as good as their expensive counterparts.

*The initials are for United States Pharmacopoeia, a 1,200-page volume, revised every five years, that is produced by a private, nonprofit association of physicians, pharmacists, chemists and biologists. Congress has repeatedly specified that U.S.P. standards, which now cover 900 pharmaceutical products, shall be accepted as minimum qualifications by Government agencies such as the Food and Drug Administration.

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