Drug Makers Make a Difference

Abstract

All drugs, the law says, must be safe and effective. Food and Drug Administration knows whether drugs are safe. It does not always know whether they are effective. But mounting pressure on Capitol Hill for low-cost generic rather than brand name prescribing may make it imperative that FDA know. Behind the consumer's desire to buy low-cost generics instead more expensive brand name drugs is the assumption that the drugs are equLal. This assumption is false. A pill is more than just an amount an active drug. All kinds ingredients are mixed with usually small quantities a chemical to make a tablet or capsule, and these ingredients can be as important to the way it works as the drug itself. There are 32 factors that can significantly alter drug behavior in the body, according to Dr. Max S. Sadove, noted University Illinois anesthesiologist. Among them are solubility, purity, particle size and even tablet size. Careful control these variables is the domain the manufacturer whose skill as a drugmaker is directly related to the uniformity his product. It is a tricky business. In one case, the manufacturer an anticoagulant called Dicumarol found that a number doctors were prescribing half-doses the drug. To make things easier for the patient, the company increased the size tablet so it could be broken in two, but did not increase the active ingredient. Patients who switched from smaller to larger pills suddenly had to take larger doses in order to get the same therapeutic effect. Studies showed the drug dissolved more slowly from the larger tablets. FDA's Dr. Frances Kelsey suggests a patient on long-term drug therapy learn the manufacturer, size and form his medicine and get the same thing each time his prescription is filled. It's not necessarily a question brands being better or worse than generics, she says. It's a question getting the same thing every time to maintain a consistent level effectiveness. Many doctors. having successful experience with a trademarked drug and no facilities to determine equivalency themselves, will continue to prescribe by brand name even though a similar or chemically identical compound may be available at less cost under its generic name. Promotional campaigns by the drug houses also play an undoubted part in brand name prescribing. Two major bills now before the Senate call for generic naming-and thus lower pricing-of drugs paid for by the Federal Government under its health programs. Senator Joseph M. Montoya (D-N. Mex.) has introduced legislation to include drugs in Medicare benefits. Senator Russell Long (D-La.) is sponsoring a bill to assure economical drug-buying in all Social Security programs. Both bills would set up an independent Formulary Committee to evaluate brand name and generic drugs to guarantee high quality in those dispensed in Government programs. FDA Commissioner James L. Goddard, who will become chairman the Formulary Committee if either bill passes, points out that very few generics would be on the approved list at first. For one thing, he says, of the 200 most frequently prescribed drugs, only about 34 have generic counterparts. But the list would surely grow as clinical tests efficacy are made. Added fuel for the controversy is expected next month with the publication The Handbook Prescription Drugs by Richard Burack, M.D., which will list trademarked drugs and their generic counterparts, with manufacturers and prices. publisher, Pantheon, offers it as a buying guide designed to help people get prescription drugs cheaper. Quite apart from the generic vs. trademark struggle, and from the subtle differences that creep in between apparently identical products, the quality drugs across the board leaves quite a bit to be desired. Consider the Department Defense, with its $125 million drug bill each year. It finds itself turning down more than half the drugs offered it; they Smith Kline and French