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AMOXICILLIN DISPUTE OVER EFFICACY AGAINST OTITIS MEDIA IN NIH-FUNDED STUDY IS AIRED BY REP. WEISS AT SEPT. 29 HEARING ON SCIENTIFIC FRAUD, INDUSTRY INFLUENCE

Executive Summary

A five-year dispute between key investigators in an NIH-funded amoxicillin otitis media study was showcased by Rep. Weiss (D-NY) on Sept. 29 as part of a continuing set of hearings into alleged scientific fraud. Erdem Cantekin, a co-investigator in a 1980-1984 study on amoxicillin for persistent (secretory) otitis at the University of Pittsburgh, told a hearing before the House Government Operations Subcommittee results of a study published in the February 1987 issue of the New England Journal of Medicine was flawed by a change in the definition of the disease under study. The journal publication "concluded that amoxicillin was effective in the treatment of secretory otitis media," Cantekin stated in his prepared testimony. "The authors of that paper, however," Cantekin contended, "had changed the definition contained in the original grant application." Cantekin, a biomedical engineer who was research director at Pittsburgh's center to study childhood ear diseases for 10 years until 1986, maintained that "under the original definition" of otitis media for the NIH study, "no argument could be made that amoxicillin had any efficacy in the treatment of secretory otitis media." The university used the NIH-funded study to draw related industry sponsored antibiotic efficacy studies, Cantekin claimed. He cited studies on Lily's Ceclor and Beecham's Augmentin as well as Pfizer work on amoxicillin levels in middle ear fluid. The Weiss hearing was an oversight, investigatory hearing. The subcommittee plans a report by spring of next year. The lead staffer for the hearing was Diana Zuckerman. The allegations highlighted by Weiss are superficially rehashing a parochial academic fight at Pittsburgh. However, the underlying charges regarding the effect of industry sponsorship of academic work may point out a potentially damaging criticism of the independence of pharmaceutical research. Drug companies directly sponsored "at least $ 1.6 mil." in antibiotic effectiveness studies at Pittsburgh between 1981-1986, Cantekin asserted. He attacked an unnamed primary investigator in the NIH-study with spending "substantial time traveling at the expense of the pharmaceutical industry to advocate use of their products, collecting honoraria in the process. " Cantekin's grievances against the study and against efforts by the university to keep his dissenting opinions out of journals have been the subject of ongoing academic proceedings at the University of Pittsburgh since April 1987. Weiss harshly questioned the current Dean of the School of Medicine at the University of Pittsburgh, George Bernier, MD, about the Cantekin charges. Weiss cited the allegations of honoraria to the primary investigator. He maintained that material provided to the subcommittee by the university indicate that that researcher "received more than $ 50,000 in honoraria each year for the last three years (1985-1987) and more than $ 25,000 per year to travel" for speaking. "Is that an unusual amount of money for a faculty member at your medical school to receive from drug companies?," Weiss asked. The Pittsburgh medical dean acknowledged that those figures were "on the high side." He said that his university's policy permits an individual to "devote an equivalent of one day per week to consultation and things like that." Weiss later questioned NIH Director James Wyngaarden about the control of honoria to investigators also working under NIH funding. Pressed by Weiss about NIH's responsibility, Wyngaarden said: "I think it is an issue that needs to be publicly addressed as far as how much the federal government should be involved with a university when it comes to these questions."

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