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Thread: Scientists, NIH, and Conflict of Interest

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    Scientists, NIH, and Conflict of Interest

    The following article is very interesting because it illustrates conflicts of issue that can occur when one holds NIH grants and do research that may have commercial significance. Government policy currently does not require that you have no conflict of interest, only that you disclose any potential of conflict of interest, and that appropriate institutional boards review these potential conflicts and recommend actions.

    So, in this case, a very well respected scientist owns stock in a company that makes mifepristone (otherwise known as RU-486, or the morning after or "abortion" pill). Among several NIH grants that he holds, he is the principal investigator of an NIMH grant to assess how this drug may affect depression. He voluntarily stepped down from being the principal investigator of this grant.

    There are two perceived issues with conflicts. One has to do with the objectivity of the scientist in studying and making decisions concerning a drug or treatment in which he/she has a significant financial investment. The second issue has to do with the possibility that the government funding may benefit the investigator personally. The former is the major issue that the NIH is concerned with and not the latter.

    Scientists, particularly those who hold decision making power in human clinical trials or animal studies, should not hold financial interest in the drugs that are being tested. Thus, for example, I purposefully avoid buying stocks or accepting personal payment from companies whose products I am testing in trial. If I hold stock in a company, I refrain from testing the products of that company.

    Note that having a conflict of interest does not mean that the scientist cannot work on a particular treatment. For example, scientist who is working in a company can study a treatment from the company but must disclose his/her relationship with the company. In general, people recognize that the scientist may be biased and therefore companies often go to third party investigators to verify internally generated results.

    Anyway, I thought that people would like to know what scientists have to think about when they are approached by companies to do consulting work for them.

    Should conflicts mean no NIH grant?
    Posted by Bob Grant
    [Entry posted at 29th September 2008 05:23 PM GMT]
    View comment(1) | Comment on this blog

    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 Sen. Charles Grassley (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 accused of failing to disclose owning millions of dollars of stock in the company that produces mifepristone (otherwise known as RU-486, 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 Joseph Biederman and Thomas Spencer, University of Texas psychiatrists Karen Wagner and John Rush, and University of Cincinnati professor Melissa DelBello.

    Interestingly, the only action taken against - or rather by - these researchers to ameliorate the apparent problems seemed to occur when Stanford's Schatzberg voluntarily stepped down 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 Thomas Insel 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.
    Last edited by Wise Young; 09-29-2008 at 02:16 PM.

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