Academic Groups Say More Drug Ties Should Be Reported

For the past year, the U.S. biomedical research community has been rocked by a Senate probe revealing that several prominent researchers have failed to properly disclose hefty payments that they received from drug companies. The National Institutes of Health is now looking at tightening its rules for overseeing conflicts of interest involving NIH grants. Yesterday, two heavyweight academic groups weighed in on possible changes. They agree that researchers need to disclose more of their income, but reject some other proposals.

Right now, NIH grantees have to report to their institutions only financial interests (consulting fees or stock, for example) "affected by the research" that exceed $10,000 per year or 5% equity interest. That threshold is too high, says a letter to NIH from the Association of American Medical Colleges and the Association of American Universities. The groups say that investigators should report everything directly or indirectly related to their research to their institutions. For reporting to NIH, they'd like to see a lower "significant" threshold: $5000 or 0.1% equity for publicly traded companies.

The two groups also agree that NIH should collect more details from institutions on the conflicts they're managing. Under the current rules, institutions just have to tell NIH that a conflict exists for a particular grant.

However, the groups don't think NIH should set any kind of limit on financial conflicts, even for studies involving human subjects. Although AAMC and AAU have recommended to their members that significant conflicts should generally be prohibited in clinical research, they say institutions need flexibility. The letter says it's premature for NIH to require conflicts policies for institutions (as well as individuals) because schools are still working out how to craft institutional policies.

"Imposing over-zealous regulations could disrupt productive partnerships to the detriment of science and the public," the letter warns. The comment period is open until 7 July, and other groups and individuals will likely weigh in. But AAMC and AAU are very influential, so the finally regulations will probably closely reflect what they recommend.