Word: oraflex
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Dates: during 1982-1982
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...Procardia letter is not the only example of an FDA corrective attack on drug-advertising practices. Last June the agency ordered Eli Lilly and Co. to revise the press kit it had prepared on Oraflex, an arthritis medication. The kit contained releases implying that the drug could retard the course of arthritis, a claim based on inconclusive animal studies. Lilly had taken the bold course of promoting its product directly to the consumer, and the misleading claim was trumpeted in newspapers and on television. The result was an enormous demand: more than $6 million in sales for Oraflex...
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...
...suspension of Oraflex in Britain, where it had been sold for the past two years under the name Opren, took place years under the name Opren, took place after the Committee on Safety of Medicines, the equivalent of the FDA, reported that it had received notice of more than 3,500 adverse reactions linked to the drug, including the 61 deaths, many of them associated with liver, kidney or gastrointestinal damage. U.S. consumer groups contend that there was no way that Lilly could not have known about the 28 British deaths that occurred prior to the drug...
Lilly, despite its voluntary withdraw al of Oraflex, continues to defend the drug. Oraflex has had "demonstrable good results" on the 1.5 million patients who have taken it, Lilly maintains, and is "safe and effective when used as directed." In an earlier statement, Lilly took "vigorous exception to any implication that it has withheld data, maintained inadequate records or failed to comply with the scientific requirements...
With any powerful drug, there is always a trade-off between the primary, beneficial effect and the cost in deleterious side effects: anticancer drugs kill healthy cells as well as malignant ones, and some drugs that relieve intense pain are highly addictive. A thorough review of the findings on Oraflex may show that given its benefits, the risks are as acceptable as those for other drugs in its class, including, significantly, aspirin. On the other hand, it may find that deliberate or inadvertent failure by Lilly to provide necessary but damaging information about Oraflex, coupled with a sloppy performance...