August 3rd, 2011

NIH Proposal On Conflicts Of Interest Is Gutted

Pharmalot

One year after proposing to strengthen conflicts of interest rules for grant recipients, the National Institutes of Health has apparently gutted a key provision that would require universities to disclose financial ties between academic researchers and industry on publicly accessible web sites, according to Nature.

Specifically, the NIH proposal would require academic researchers who receive agency funding to more thoroughly report any financial conflicts of interest, and also require institutions - such as universities - to do a better job of gathering this information and then forwarding it to the NIH. This would include posting info on a web site.

At the time the proposal was made in May 2010, NIH director Francis Collins (see photo) told a media briefing that “the way in which science is moving forward, in order to be successful, partnerships between NIH funded researchers and industry are essential, they have been and will be, but we need to preserve the public trust” (read here).

He also wrote this in the Journal of the American Medical Association: “The public may not always understand the intricacies of rigorous science, but most individuals quickly grasp the concept of bias. Plain and simple, Americans do not want financial conflicts of interest to influence the federally funded research they hope will yield better ways to fight disease and improve health.”

The disclosure requirement has been seen as a crucial element of the proposal, which was made after a probe by the US Senate Finance Committee that uncovered several instances in which academic researchers accepted funding from both the NIH and drugmakers, but failed to fully or properly disclose the extent of their financial ties. At the same time, several universities failed to monitor their faculty for conflicts.

One example involved three prominent psychiatrists, including Joseph Biederman, from Harvard Medical School and Massachusetts General Hospital who were sanctioned last month for violating conflict of interest rules and failing to report the extent of their payments (see here). Another involved Charles Nemeroff, who left Emory University after accepting sizeable consulting fees from Glaxo at the same he was the primary investigator on an NIH-funded grant for research into a Glaxo drug (see here).

A spokeswoman for the the NIH Office of Extramural Research would only say that the proposal is “under consideration by the Office of Management and Budget” (look here). Last month, the Project On Government Oversight watchdog group wrote to the OMB in hopes of persuading the office not to rollback disclosure requirements. At the time, POGO pointed out the effort contradicted the stated goal of the Obama administration to promote transparency in government.

POGO says a key official behind the move was Cass Sunstein, who heads OMB’s Office of Information and Regulatory Affairs. “The word on the street is that Cass Sunstein is behind this,” says Paul Thacker, a POGO investigator, who previously worked as an investigator for the Senate Finance Committee. “He’s industry’s best friend inside the White House. He doesn’t like regulations.” We asked the OMB for a comment and will update you accordingly.

“It’s an unfortunate such a clean science and straightforward rule should be trappedd at OIRA, because there isn’t any reason for it,” Rena Steinzor, a professor at the University of Maryland Law School and president of the Center for Progressive Reform, tells us.

By rolling back disclosure requirements, connecting the dots will be a harder task. “By stepping back, disclosure will be more difficult. You can still get the info, but it will require more effort and it would be much harder to do an analysis across the country and see what’s going on,” Sid Wolfe, who heads the Health Research Group at the Public Citizen consumer advocacy group, tells us. “Those people who keep denying conflicts of interest is not a problem are in denial.”

Notably, the NIH proposal would require institutions to disclose financial conflicts among NIH-funded researchers on a grant-by-grant basis, Nature notes. Examples would include anything of monetary or potential monetary value, such as consulting fees or stock, which “could directly and significantly affect the design, conduct, or reporting” of research (see page 19 here).

The universities would then have to post the info on a web site and this could be accessed for at least five years. But a government official with knowledge of the ongoing talks on the proposed NIH tells Nature that institutions will now be allowed to choose how to disclose the info and will not be obligated to place the details on online.

The proposal, by the way, already faced opposition from several groups, including the Association of American Universities and Association of Medical Colleges, which filed a letter last August arguing that “there are serious and reasonable concerns among our members that the Web posting will be of little practical value to the public and, without context for the information, could lead to confusion rather than clarity regarding financial conflicts of interest and how they are managed” (read the letter here).

“One of the problems with disclosure of conflicts of interest is that it is not done on a uniform basis across institutions. This was a step in the direction of some sort of uniformity, but I’m not sure this will be protected. It’s a lot easier for anyone who wants to study this issue and compare and contrast when there is a database than to go to each university and dig,” Sheldon Krimsky, a professor of Urban & Environmental Policy & Planning at Tufts University. “I’m sure the universities are jumping for joy. It’s a big investment of time and money to provide disclosure this way.”

Read more: http://www.pharmalot.com/2011/08/nih-proposal-on-conflicts-of-interest-is-gutted/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Pharmalot+(Pharmalot)&utm_content=Twitter

Comments

Add your own Comment

(optional)