Accepting More Federal Oversight

July 9, 2008

Recent high-profile revelations and a growing consensus on Capitol Hill are leaving research universities ready -- or, as the case may be, resigned -- to a stronger federal role in regulating the management and disclosure of biomedical researchers' financial interests.

Until now, the academic response to periodic external scrutiny of potential research conflicts has been increasingly to assert that it can police itself. In 2001, the Association of American Medical Colleges issued recommendations for strong conflict-of-interest policies after the death of a research volunteer triggered an investigation into whether such conflicts contributed to gaps in the review process at Johns Hopkins University. The Association of American Universities followed suit with its own report the next year.

Then in February of this year, both organizations jointly issued an updated set of guidelines initially spurred by a conflict-of-interest scandal at the National Institutes of Health. They called for stricter institutional policies, better coordination among universities and an end to delays in putting such policies into practice. (An AAMC study found, for example, that only 38 percent of medical schools had such policies in place as of 2006.) Still, the implicit message sent to both research institutions and lawmakers was: We've got things under control.

But that was before a new string of revelations began circulating in the media, bombshells originating from the office of longtime drug industry critic Charles Grassley, the Republican senator from Iowa, which has been tracking researchers whose financial ties may jeopardize the objectivity of their work. Now several levers of government seem to be converging on Washington's solution of choice: attaching conditions to the purse strings.

Last week, the Senate Appropriations Committee approved a funding bill that, at the moment, contains language inserted by Sens. Arlen Specter (R-Pa.) and Tom Harkin (D-Iowa) that would require the Department of Health and Human Services, within six months of the bill's passage, "to solicit public comment in advance of modifying regulations ... for the purpose of strengthening federal oversight and identifying enhancements of policies, including requirements for financial disclosure to institutions, governing financial conflicts of interest among extramural investigators receiving grant support from the National Institutes of Health." Similar ideas are percolating in the House of Representatives.

Meanwhile, the NIH itself is considering the possibility of opening the same regulations for public comment -- presumably, on how to make them more stringent -- even if legislative action isn't taken. In response to a letter from Grassley early last month, Elias A. Zerhouni, the NIH's director, wrote, "[I]t is clear that we need to increase transparency and enhance the NIH's system of oversight."

Grassley's efforts seem to have encouraged something of a consensus among the key players, including AAU, the group that represents major research universities, and leaders in both houses and in several committees have kept in contact about boosting the federal role in the oversight of financial disclosures and conflict-of-interest management -- the twin prongs of institutions' strategies to minimize the potentially corrupting influence of pharmaceutical money that funds much biomedical research.

"We’re acknowledging that it seems to be moving in that direction," said Barry Toiv, the AAU's vice president for public affairs, regarding a more prominent federal role.

Now that the process may be beyond the point of no return, the association and, likely, other groups will make sure they're included in discussions about new oversight, beginning with the possibility that the federal regulations will be opened to the public for comment. "It seems pretty clear that there will be [a greater federal role], and we want to work with the NIH to make sure that what’s done is effective and that in addition to promoting safety ... [it] also continues to promote science” and the research community, he said.

Patrick White, the association's vice president for federal relations, said this wasn't a shift in the AAU's position on conflicts of interest so much as a natural progression. "The [February] report furnishes recommendations, but also examines issues ... that would be looked at in the context of a reopened regulation," he said. As such, the AAU would be in a position to “talk about this with some authority, for want of a better term, with some good will, because we have thought so long and so hard about it.”

What new regulations might look like, if they're reopened, is far from certain. Currently, universities bear most of the enforcement burden themselves, although that could change depending on the political winds and other factors.

"We don’t know how NIH will want to or be pressured to modify the regulation. I would hope that they would retain the delegated responsibility for identifying and dealing with conflicts of interest, because it’s a very complex thing that really would resist centralization at the NIH," said Julie Gottlieb, assistant dean for policy coordination at the Johns Hopkins University School of Medicine. "Whether there is enhanced reporting by institutions to NIH, that might be part of where they’re going, I don’t know."

Still others believe that the best policy remedy has already been proposed: Grassley's own Physician Payments Sunshine Act, which would require pharmaceutical companies and medical device manufacturers to disclose in a national registry the payments they make to medical doctors. Without such a mechanism, said Eric G. Campbell, a professor at the Institute for Health Policy at Harvard Medical School, it's "likely to be a policy without teeth."

"The devil is in the details when it comes to that kind of stuff," he said.

Another potential drawback to an additional set of regulations at the federal level is the possibility that it could hamstring researchers with additional reporting requirements. On one level, most would agree that more muscular oversight would require more resources. "[W]hatever happens is likely to require a lot of additional expenditure of resources at the institutional level, and if there’s a way to make that happen to minimize those additional expenses, that would be ideal," Gottlieb said.

Meanwhile, some critics oppose additional layers of bureaucracy regardless of where they come from.

"I think it’s very hard for young people starting out, and every time you create another layer of difficulty, there is a tendency to say, 'Why should I even bother?'" said Jonathan Moss, a professor of anesthesia and critical care at the University of Chicago Medical Center who chaired the institutional review board there for over 10 years.

It's a “paperwork solution to a non-problem," he said. "I’ve not seen evidence ... reviewing over 7,000 protocols, of a significant problem. Why impose an extra layer of complexity on something where really the problems are miniscule, in my view?"

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