Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



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."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts