Unfortunately, an IRB—which is set up to approve research protocols in a clinical trial and ensures that patients are treated properly—is ill equipped for answering questions about financial conflicts of interest. “The composition of an IRB was never designed to handle [conflict of interest] in today's world,” notes Arthur Caplan, a bioethicist at New York University Langone Medical Center (and a member of the board of advisers for Scientific American). “It's pretty clear to me that this guy at Helen Hayes has a pretty serious conflict,” Caplan says. Carl Elliott, a bioethicist at the University of Minnesota, agrees. “The IRB was the wrong body to ask for an opinion,” he told me in an e-mail.
In any case, Helen Hayes is not geared to rooting out conflicts. Lawyers there adapted the boilerplate language from NIH grant guidelines requiring that a researcher report, among other things, “anything of monetary value, in cash or in kind, from a research sponsor (e.g., consulting fees, honoraria, or travel, meals or entertainment).” (Italics added for emphasis.) The inserted clause narrows the scope of what needs to be disclosed. Because Lilly is not the sponsor of Lindsay's research—the NIH is—payments from Lilly would not seem to be a conflict of interest under these guidelines. Indeed, it is difficult to conjure a circumstance in which an NIH grantee would have a conflict of interest under Helen Hayes's rules. There is no reason to think that Helen Hayes is special in this regard. Institutions that administer grants have no real incentive to worry about conflicts. The more grant money their employees get, the better for the employer. Why kick up a fuss?
This article was originally published with the title Is Drug Research Trustworthy?.