Triparanol Side Effects

Even after the most exhaustive tests, unexpected and harmful side effects of a new drug are sometimes discovered only after the drug has been put on the market. What bothered the Food and Drug Administration about the synthetic hormone substitute, triparanol, was that some of its harmful effects had been clearly indicated in advance.

Sold by Cincinnati's William S. Merrell Co. under the trade name MER/29, triparanol was supposed to lower the level of cholesterol in the blood and, presumably, reduce the risk of heart attacks. But too many people who took the drug later went bald, became impotent, or went blind from an unusual form of cataract. In applying for approval of MER/29, said FDA, Merrell improperly withheld information already in its files that triparanol had caused cataracts in animals.

Last week the Merrell Co. was on trial with three of its former executives and parent Richardson-Merrell Inc. on twelve counts of supplying FDA with "false, fictious and fraudulent" data. After first pleading not guilty, the companies and the executives switched their pleas to nolo contendere (no contest) on eight counts. After Federal Judge Matthew M. McGuire made sure that each defendant understood that the new plea was "tantamount to a plea of guilty," the Justice Department dropped the four remaining counts. It is now up to Judge McGuire to fix the sentences. For the companies, fines could total up to $80,000; the individuals face both fines and prison.

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