By Jocelyn Kaiser
ScienceNOW Daily News
A group of universities today unveiled its answer to public concerns about drug company payments to biomedical researchers: a manual to help schools navigate these conflicts of interest in clinical research. Although there have been other reports released on this topic, this one contains more detailed guidance as well as some new hard-hitting recommendations.In 2004, revelations of unreported financial conflicts of interest in the intramural program at the U.S. National Institutes of Health prompted a ban on industry consulting by NIH scientists. Hoping to stop Congress from imposing such drastic measures in academia, the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU) have now produced a guidebook for universities on how to handle conflicts of interest in clinical research, which might arise, for example, when a researcher consults for a company whose drug she wants to test. Penned by a 21-member committee of deans and others at major research institutions around the United States, the roughly 80-page report* elaborates on recommendations the two groups released in 2001 and 2002.
The advice is more detailed and more pointed than in the past. For example, the report gives schools a 2-year deadline for implementing a conflict-of-interest policy and provides a model of what one might look like. (A recent study found that 62% of medical schools surveyed still don’t have such a policy; see Science, 15 February, p. 889). It also includes 10 case studies of real situations to help schools manage various conflicts that might arise, such as a researcher who invented a medical device and wants to help a company test it in people.
In addition, AAMC and AAU now recommend that researchers report all industry payments to their institution–not just those above a $10,000 or 5% equity threshold set by the government for NIH grantees. The reason for this “major change” is that interest from the public and Congress “is so keen right now,” says AAMC Senior Vice President David Korn. He notes that a half-dozen states have passed laws requiring that all payments from drug companies to physicians be made public, and Senator Charles Grassley (R–IA) has introduced similar federal legislation. The proposed legislation would mandate such reporting; the guidebook’s recommendations are voluntary, and schools need not follow them.
Reporting all drug company payments “is certainly a positive step, because even small gifts can distort one’s objectivity,” says conflict-of-interest expert Sheldon Krimsky of Tufts University in Medford, Massachusetts. He calls the AAMC-AAU report “a serious effort” but notes that it has some limitations. For instance, it doesn’t say that conflict-of-interest decisions should be made public.