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Executive Summary

SUPROL (SUPROFEN) FLANK PAIN ADVERSE REACTIONS TOTAL 270 cases, FDA reports in response to a Health Research Group request for withdrawal of the McNeil nonsteroidal anti-inflammatory. "The Suprol reaction," FDA said in a Sept. 25 statement, "has occurred in about 270 cases that FDA is aware of, but the reactions have been temporary and reversible in all cases studied to date." That figure indicates a growing number of reactions; McNeil reported 100 cases of back pain and associated decreased kidney function in a July mailing to MDs. The mailing itself, however, could be increasing the reports of side effects. When McNeil first made information about the side effect public in May, the incidence rate appeared to be about .005% (one case in every 18,750 patients). In July, the rate was .02% (one in every 5,000 patients). The company says that it "can't estimate a revised incidence rate at this time." According to one use estimate, however, FDA's 270 cases translate into a side effect incidence of approximately .03% (one in every 3,110 uses). Health Research Group Director Sidney Wolfe petitioned for the removal of Suprol from the U.S. market on Sept. 25 via a letter to FDA Commissioner Frank Young. Citing data from FDA, Wolfe maintains that as of July the mean age for about three-quarters of the adverse reactions was in the mid-thirties. Wolfe contends that product ads continue to target that age category. HRG is asking for the product to be withdrawn; however, the consumer group is not seeking an "imminent hazard" removal of the product as in the case of the Feldene petition earlier this year, which was denied. J&J objected to HRG's claim that Suprol has caused "more than 100 cases of kidney damage." The firm noted that "there has been no kidney damage." J&J said: "Where there has been a change in kidney function, that has been reversible simply by halting use of the drug." The company maintained that "we know of no reason why removal of the drug from the market is appropriate as long as physicians have proper prescribing information." FDA reported that J&J is revising the Suprol labeling "to reflect the problem and suggest use of alternative drugs, when effective." The agency said it would ask for "further action" if it is determined that Suprol causes "irreversible kidney failure." To support the claim of kidney damage, HRG is attempting to link Suprol with SK&F's withdrawn heart drug Selacryn (ticrynafen). HRG said that a computerized chemical search for suprofen turned up six drugs, one of which was ticrynafen. J&J pointed out that suprofen is also chemically related to the widely-used Rx/OTC chemical ibuprofen. HRG charges that J&J submitted falsified data to FDA on the suprofen NDA. The company had to withdraw its NDA for the product in 1979 due to the discovery of data problems in trials monitored by a clinical trial firm, BioBasics. The information about the trial discrepanics was the subject of a Capitol Hill hearing before Sen. Kennedy's Health Subcommittee on Oct. 11, 1979 ("The Pink Sheet" Oct. 15, 1979, p. 8). J&J said that the studies which were disqualified were repeated "using other investigators." A June 25, 1985 memo by FDA reviewer John Harter questioning the "workmanship" of the J&J Suprol submission is also cited by HRG in its allegation of data falsification. Harter noted that FDA reviewers had "communicated [a] lack of confidence" about the J&J NDA to the company's top management "but as far as we can tell it has had little effect on tying up the loose ends in this application." Harter's Suprol memo was written within one week after a difficult meeting between J&J Chairman James Burke and FDA staff on how to improve company-agency relations. At that June 19, 1985 meeting, Harter strongly expressed his personal feelings of distrust of J&J regulatory relations ("The Pink Sheet" July 15, 1985, T&G-3). The Suprol petition comes within two weeks of HRG's promise to continue to question Pfizer's NSAID, Feldene ("The Pink Sheet" Sept. 15, p. 5). FDA Freedom of Information records indicate that HRG is continuing to search for information about Feldene. On Sept. 9, HRG requested information on a Pfizer compound which is no longer being studied, sudoxicam, and a manuscript on piroxicam submitted to the Journal of the American Medical Association by FDAers.

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