THE SAFETY OF SYMMETREL

Ever since the Food and Drug Administration's careful checking procedures saved the U.S. from the 1961 thalidomide disaster, the agency's critics have accused it of becoming overcautious and of needlessly delaying the marketing of valuable new drugs. This week the FDA stands accused of just the opposite--of having too hastily approved a drug that may not be safe enough for widespread use.

The drug, Du Font's amantadine hydrochloride, is virtually the only medicine effective in preventing viral infections. Trade-named Symmetrel, it has been tested on more than 3,000 human subjects, and has shown remarkable effectiveness in protecting against Asian-A influenza. For an adult the effective dose of amantadine is 200 mg. a day, a tiny fraction of an ounce.

The trouble is that a tiny fraction more is dangerous; even a young adult in good condition suffers severe side effects with a dose of only 300-400 mg. The reactions observed among medical students, reports the University of Illinois' Dr. George Gee Jackson, "were predominantly alterations of the emotional state and of cerebration. These students complained of inability to concentrate and depression. Several described sensations of depersonalization and altered body image. There was a remarkable degree of associated anxiety." At doses of 400 mg., nearly every volunteer suffered such effects. Fortunately, the effects subside in a few hours if no more amantadine is taken.

After hearing Dr. Jackson's report, the University of Cincinnati's Dr. Albert B. Sabin, developer of oral polio vaccine, declared: "There is great concern about the large-scale use of this drug because its margin of safety is very, very narrow."

FDA Commissioner James Lee Goddard refused to back down. "The risks involved in using the drug were weighed against the possible benefits," he said in an interview in Medical Tribune. Information sent to physicians, he added, warns them against possible adverse reactions. And he promised continued cautious monitoring in the hope of finding ways to avoid them.

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