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Another Whack at Biomedical Research Conflicts

June 27, 2008

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Sen. Charles Grassley isn't on the U.S. Senate Appropriations Committee. But that hasn't stopped the Iowa Republican from prodding Congressional budget setters to join his campaign to rein in perceived conflicts of interest in biomedical research, which they did with gusto Thursday.

As the full Senate appropriations panel embraced without major change legislation drafted earlier this week by a subcommittee to finance the Departments of Education, Labor and Health and Human Services in 2009, Grassley was not among the 30-odd senators in the room. But the actions they took were fully consistent with his recent push to ensure that federal and university officials are fully aware of the extent of financial and other relationships between academic researchers and pharmaceutical and other companies that fund research. (Grassley has harshly criticized researchers at the University of Cincinnati and Harvard University, and this week he turned his gaze on yet another psychiatrist, this time at Stanford University.)

The committee's original bill, which the panel has not yet released to the public, did not address the subject, but the accompanying report contained language that, in no uncertain terms, encouraged officials at the National Institutes of Health to address the problem of conflicts of interest. "Troubling allegations that some NIH-funded investigators have flaunted their universities' conflict of interest rules have recently come to light, and it seems clear that the NIH currently has no ability to monitor or prevent such abuses," the appropriations report said. "Moreover, up to this point the NIH leadership has not demonstrated much interest in dealing with the issue. That must change.

"The committee believes that the director has no higher priority in the coming year than to address this situation and fix it."

In a letter Wednesday to Sens. Robert Byrd (D-W.V.) and Thad Cochran (R-Miss.), the chairman and senior Republican, respectively, on the full Appropriations Committee, Grassley suggested that the Senate appropriations panel go further. "NIH oversight of the extramural program is lax, creating a $24 billion problem," Grassley wrote. "I am asking you to join me in holding the NIH accountable until it addresses this issue in a prompt and complete manner. Accordingly, I am suggesting that as part of the appropriations process, language be considered ensuring that the NIH is fully apprised of any conflicts existing among those individuals receiving NIH funds."

At Thursday's markup of the legislation, Sen. Wayne Allard, a Colorado Republican, offered an amendment that would have directed the NIH's director, Elias Zerhouni, to begin the process of soliciting opinion about how to draft new rules to govern potential conflicts of interest among NIH-funded scientists at colleges and universities. "I want to assure that they begin to modify [regulations for monitoring] extramural research and keep Congress informed," said Allard.

The lawmakers shepherding the education and health spending bill through the legislative process, Sens. Tom Harkin (D-Iowa) and Arlen Specter (R-Pa.), offered their own "friendly" alternative to Allard's proposal that would push the envelope even farther and crank up government scrutiny. Their proposal, which may still be tweaked as it moves through the legislative process, would require the Department of Health and Human Services (of which NIH is a part) to begin, within six months of the law's passage, a process of negotiated rule making that would lead to new (and presumably tougher) regulations on conflicts of interest in NIH-funded research.

"Our substitute amendment takes a little more comprehensive view," said Harkin. Allard's amendment, he said, "wouldn't require NIH to do anything," with the responsibility for monitoring conflicts of interest "borne entirely by the academic institutions that employ the scientists. The NIH provides the funds, so it ought to have a role in their oversight."

Other than the amendment on conflicts of interest, the bill the full Senate panel approved mirrors the version passed Tuesday by the appropriations subcommittee. It would provide $30.2 billion in funds for the NIH in the 2009 fiscal year, and increase the maximum Pell Grant by $69, leaving most other student aid programs flat.

Thursday was supposed to be a day when appropriations panels in both houses approved their spending bills for education, health and labor programs, but the House spending panel hit a major partisan roadblock. Frustrated by the panel's delay in taking up the spending bill for the Department of the Interior -- through which lawmakers hoped to provide some relief for Americans on gas prices by approving offshore drilling for oil -- the Republican leader of the House Appropriations Committee, Rep. Jerry Lewis of California, engaged in a parliamentary procedure in which he sought to replace the health and education bill with the Interior measure.

The ploy infuriated Rep. Dave Obey of Wisconsin, the Democrat who heads the spending panel. "It's stunts like this that make people hate Washington," Obey said, calling for adjournment of the committee and threatening to shut down the appropriations process.

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Comments on Another Whack at Biomedical Research Conflicts

  • conflict of interest
  • Posted by steven clark, PhD at UW on June 27, 2008 at 8:45am EDT
  • The recent conflict of interest problems that raised Sen Grassley's ire are no-brainers. Over the years, there has been a lot of press coverage on this topic. My university, the UW-Madison and all others have CoI regulations. No one should be caught up in such flagrant conflicts as have been recently uncovered.

    Having said that, it must be recognized that such rule violation is flagrant and will continue as long as folks think that they can get away with it. Penalties need to increase to have any meaninful impact on "willfull" violation of CoI rules.

    Steven Clark

  • Did the report really say "flaunted"?
  • Posted by Word Police on June 27, 2008 at 9:35am EDT
  • The word is "flouted" -- if they are ignoring them, that is...if they are bragging about their universities guidelines and rules, perhaps they would flaunt...You'd think the investigating body would at least get it right.

  • Posted by Frank on June 27, 2008 at 10:25am EDT
  • Why is Grassley is still concentrating on psychiatry alone?
    Is he exploiting the stigma of mental illness to his favor?
    Could showing similar practices in Cancer research backfire on him? Just some questions.

  • Federal regulation boomerangs
  • Posted by PQuincy , Professor at Out West on July 7, 2008 at 3:35pm EDT
  • Considering the way that human subject regulations have gone from a worthwhile and useful corrective to past failures, to an out-of-control system that mindlessly seeks to control the research of anthropologists, historians, and others far from medical research, we should be skeptical and cautious about wishing for more Federal regulations.

    Have there been major conflicts of interest in Biomed? Of course -- the field is rife with them, not only in connection with corporate interests, but in how NIH grants are awarded, in peer review processes for journals, and elsewhere.

    But that's only one side of the story, which I weigh against my shock when, at a Washington workshop in my discipline a few years ago, at hearing a Department of HHS bureaucrat calmly tell me that every last paragraph of human subjects rules -- including anonymity of subjects, which really doesn't work so well when you're, say, writing a biographical study of a 20th century figure! -- are completely applicable to historians. The only option she offered us, in a weirdly Kafkaesque turn, was to deny that what humanists and social scientists do is 'research'.

    Academic administrators and professional associations need to get serious about conflicts of interest, which both have all too often furthered, or at least ignored. Federal rule-making, in contrast, is a wish to be very very careful about.