Word: oraflex
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When Eli Lilly & Co. introduced Oraflex last May, the new anti-inflammatory drug was hailed as a breakthrough for the 30 million Americans who suffer from arthritis. Oraflex (chemical name: benoxaprofen) seemed to be less irritating to the stomach than aspirin, the staple treatment for arthritis victims. The drug produced side effects, notably an increased sensitivity of the skin and nails to the sun, but these seemed minor compared with the benefits...
Within three months, however, the promise turned to peril. Several consumer organizations, including Ralph Nader's Health Research Group, went to court seeking a ban on the drug as an "imminent danger." Last week, spurred by reports that 72 Oraflex takers had died and hundreds had been injured in Britain and the U.S., Lilly said that it was recalling all supplies of the drug. Earlier that day Britain's Health Ministry suspended the supply and promotion of the drug for 90 days "on grounds of safety." Meanwhile U.S. officials were considering whether to prosecute the giant international drug...
Lilly's action followed hearings before a House subcommittee, during which FDA Commissioner Arthur Hayes Jr. said reports of 61 Oraflex-linked deaths in Britain and eleven in the U.S. were under investigation. An internal FDA memo given to the committee charged that in its application for approval of Oraflex in 1980, Lilly had seriously underreported the incidence of some negative side effects, such as failing to acknowledge 65 out of 173 cases of nonfatal adverse reactions. (It did report them later.) The memo said that some of the firm's reports to the FDA were "untrue...
...prove that Oraflex does retard this destructive process, Lilly has embarked upon a three year, 1,600-patient study. A number of researchers doubt, however, that Oraflex is unique in its action on macrophages. Pfizer Medical Director Dr. John Jefferis maintains, "Feldene does everything benoxaprofen does." Says Dr. Frederic McDuffie of the Arthritis Foundation: "I would predict that whatever effect you could get with benoxaprofen you also could get with aspirin, if you gave enough...
...some patients, the new drugs have already succeeded where aspirin failed or proved too irritating to tolerate. Jo Ann Schwartz, 50, of Topsfield, Mass., was taking 18 Bufferins daily and still finding it too painful to walk upstairs. She became a subject in an Oraflex study, and "within 30 days, I could start doing things again," she says. She is now back on her bicycle and kicking up her heels in the pool. But Schwartz was one of the lucky ones. About 20% of arthritis sufferers are not helped by the new drugs. For them, the search continues...