Much has been written about financial conflict of interest involving an individual faculty member who receives remuneration in one form or another from a commercial entity like a pharmaceutical company. Little notice has been given, however, to the conflicted positions in which universities and hospitals may possibly find themselves. Institutional conflict of interest is a relatively new but growing subject of concern, one worthy of further study.
A couple of months ago, I had a conversation with the president of a major research university, which had licensed a new drug to Pfizer. The drug was about to receive FDA approval, and the expected royalties from the drug might run into the hundreds of millions of dollars per year. Not long after that, I read about a report detailing a couple of cases in which a rare form of blindness occurred in patients who were taking either Viagra or a similar drug. These two unrelated occurrences got me to thinking.
Consider the following hypothetical case: Suppose you were the chair of the board of trustees of DuPont University (with apologies to Tom Wolfe and the main character of his latest book, Charlotte Simmons). Suppose also that DuPont U. is receiving $200 million a year in royalties from Big Drug Inc. for a particular drug and that one of the young DuPont faculty members has just written an article indicating that taking this drug in some very small number of cases can cause blindness. One day, in your role as board of trustees chairman, you get a call from Big Drug Inc.’s CEO, who threatens to stop all payments unless the untenured faculty member is convinced to print a retraction or a mitigating follow-up paper. You know (as does Big Drug’s CEO) that without those royalties, the university’s expansion program will be halted and serious deficits will be incurred. So you call the DuPont University president to ask her to throttle the offending young physician.
Ah, you say, this could never happen!
But consider the real-life case of Nancy Oliveri from the University of Toronto Hospital for Sick Children. Oliveri was conducting a study of a drug sponsored by Apotex, the manufacturer of the drug and the largest pharmaceutical company in Canada. After an initial publication providing positive results, she began noting liver toxicity in patients and wanted to notify the IRB about these side effects. Apotex, citing a clause in the research agreement in which the investigators agreed to keep all results confidential unless approved by the company, barred her from disclosing these complications.
Oliveri decided to go to the IRB anyway. Apotex terminated the study and removed her from the steering committee. The University of Toronto and the Hospital for Sick Children, instead of coming to her defense, removed her as hemoglobinopathies program director at the hospital and refused to defend her against lawsuits from Apotex. She was ultimately vindicated in a detailed investigation. Only later was it revealed that the University of Toronto had been negotiating with Apotex for a $20 million donation to the university for a biomedical research center.
Institutional conflict of interest presents a new minefield that must be carefully navigated to protect the interests of the public and the reputation of the institution. Expect more to be heard on this topic in the lay press and medical journals in coming months.
