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Should conflicts mean no NIH grant?

If you've been following the news of NIH-funded researchers seemingly entangled in webs of unreported, underreported, or misreported financial ties to industry over the past year or so, you know that the buck often stops at the desk of linkurl:Sen. Charles Grassley;http://www.the-scientist.com/blog/display/54832/ (R-IA). You might have also noticed that many of the subjects of Grassley's recent inquiries are psychiatrists who are funded by NIH's National Institute of Mental Health (NIMH). In fa

By | September 29, 2008

If you've been following the news of NIH-funded researchers seemingly entangled in webs of unreported, underreported, or misreported financial ties to industry over the past year or so, you know that the buck often stops at the desk of linkurl:Sen. Charles Grassley;http://www.the-scientist.com/blog/display/54832/ (R-IA). You might have also noticed that many of the subjects of Grassley's recent inquiries are psychiatrists who are funded by NIH's National Institute of Mental Health (NIMH). In fact, of the past eight researchers investigated by Grassley over the last year, at least six have been NIMH grantees. The most prominent of these was Stanford researcher Alan Schatzberg, president-elect of the American Psychiatric Association, who Grassley linkurl:accused;http://www.the-scientist.com/blog/display/54771/ of failing to disclose owning millions of dollars of stock in the company that produces mifepristone (otherwise known as linkurl:RU-486,;http://www.the-scientist.com/article/display/10905/ the "abortion pill"). Schatzberg was the principal investigator on an NIMH grant to study the drug's effectiveness in treating depression. Other NIMH-funded researchers that have recently come under Grassley's intense scrutiny include Harvard psychiatrists linkurl:Joseph Biederman;http://www.massgeneral.org/pediatricpsych/staff/biederman.html and linkurl:Thomas Spencer,;http://www.massgeneral.org/pediatricpsych/staff/spencer.html University of Texas psychiatrists linkurl:Karen Wagner;https://psychiatry.utmb.edu/Clinical/Patient/Provider.asp?id=48161 and linkurl:John Rush,;http://www8.utsouthwestern.edu/findfac/professional/0,2356,16290,00.html and University of Cincinnati professor linkurl:Melissa DelBello.;http://www.psychiatry.uc.edu/index.php?q=node/27 Interestingly, the only action taken against - or rather by - these researchers to ameliorate the apparent problems seemed to occur when Stanford's Schatzberg linkurl:voluntarily stepped down;http://www.the-scientist.com/blog/display/54935/ as PI on the NIMH mifepristone grant. (He remains the PI on two other NIMH grants). The other five investigators remain in possession of their NIMH grants and have not been outwardly disciplined by their respective institutions. I asked NIMH director linkurl:Thomas Insel;http://www.nimh.nih.gov/about/director/index.shtml if his agency could be doing more to mitigate or prevent such disclosure mishaps, and whether the information gathered by Grassley and his staffers in the Senate Finance Committee - financial records from pharmaceutical companies and disclosure documents from NIMH-funded scientists - was enough to suspend researchers from receiving NIMH grants relating to the cases. Perhaps, said Insel, but the agency collects its own information once Grassley brings such irregularities to light. While he declined to provide specific information on the actions being taken or considered against NIMH-funded investigators already called out by Grassley, Insel did say that his agency convenes "small groups of people," such as program directors and grants policy administrators, to review pertinent documents from investigators, home institutions and any industry partners tied to the researchers. Insel said that that NIMH was still in a "fact finding mode" with regard to the above researchers. "If someone is determined to have violated [conflict of interest] linkurl:policy;http://grants.nih.gov/grants/guide/notice-files/not95-179.html and it has been demonstrated without doubt, we've got a problem with providing on-going funding," Insel said. "The worst thing to do would be to make a decision in the absence of full information." Insel added that yanking funding from investigators with undeclared conflicts or asking those researchers to step away from a grant to make way for a different PI is "always on the table." Grassley wrote that this threat might be just what the doctor ordered to shore up conflicts among NIH-funded researchers. "The simple threat of losing a highly valued NIH grant would force accurate financial disclosure to grantee institutions and bring about more openness in the medical community," he wrote in an E-mail. "The NIH needs to employ its substantial resources, beyond the $24 billion it distributes for medical resources, to spot check and foster a culture within the research community that there will be consequences for disclosure and reporting that is inaccurate or incomplete for any reason." As far as Insel is concerned, that vision is unlikely. He said that a beefed up NIH conflict of interest policy might involve the oversight of a third-party group, like those that manage human trial subject safety and the use of linkurl:animals in research.;http://www.the-scientist.com/article/display/54494/ "I think that is one possibility," he said, adding that NIH becoming the sole manager of conflicts among its extramural grantees is unlikely. "I don't think we'll ever get to a point where NIH wants to be a policeman or woman for conflicts of interest." Meanwhile, there is some indication that individual universities are taking steps to tighten up their own disclosure policies to try and prevent the inadequate reporting of conflicts of interest among faculty members who vie for NIH funding. "Can [universities] affirm the public's trust in what it is we do?" asked linkurl:Patrick White,;http://www.sagecrossroads.net/node/113 the linkurl:Association of American Universities';http://www.the-scientist.com/blog/display/54394/ vice president for federal relations. "In some sense, I think we have no choice. We must, and we will." "Should we do more?" White added. "Almost certainly."

Comments

Avatar of: RICHARD MAILMAN

RICHARD MAILMAN

Posts: 18

September 29, 2008

Wording is very important -- even when personal financial issues are not at issue (e.g., in the NIH peer review system), there are occasional conflicts, but this is inherent in an interactive world. It is not "Conflicts of Interest" that are the problem (as suggested by the headline), but unreported or mishandled CoIs as the story makes more clear.
Avatar of: anonymous poster

anonymous poster

Posts: 4

September 29, 2008

all of the institutions under investigation by grassley are conducting their own inquires and will take appropriate action when completed and if warranted.\n\nthe issue came to light, in most cases, only when grassley got lists from big pharma as to who they paid and matched them with filings to NIH and institutions. there would have been no reason for the institution to have taken action if it didn't know there was a violation.\n\nin addition, the PI who asked to be removed and had asked before this came to light. \n\nthis is an evolving and more nuanced story that appears here.
Avatar of: Ellen Hunt

Ellen Hunt

Posts: 199

September 29, 2008

NIH is, bluntly put, a spineless amoeba regarding investigation and prosecution of scientific misconduct. The problem is widespread, and increases the closer you get to the financed edge of medicine. \n\nGrassley is doing a necessary service. But he is not hitting nearly hard enough where it matters. A good scientist is nearly certain to have patents and be able to make good investment decisions in his or her area. Take all of those with potential conflicts out and you will be eliminating some of the best, most productive investigators. \n\nWhat is needed is enforcement of disclosure provisions with real teeth, and a completely new NIH investigations body that prosecutes scientific misconduct with some zeal. The current DOI is ridiculous.

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