What Conflict? The NIH And A Bucket Of Money

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melissa-delbello.jpgIn his quest to peel back the curtain on the interplay between pharma and docs, Chuck Grassley offered an interesting example last week while speaking on the Senate floor. He noted that an ‘inconclusive’ 2002 study in the Journal of the American Academy of Child and Adolescent Psychiatry on AstraZeneca’s Seroquel was used to devise guidelines for treating bipolar disorder with antipsychotics.

The lead author was Melissa DelBello, a University of Cincinnati professor, who in 2003 received more than $100,000 from AZ, which sells Seroquel and paid her $80,000 in 2004. The money was for lectures, consulting, advisory board work and travel reimbursement. DelBello later reported $100,000 in outside income to the university between 2005 and 2007, although AZ says she was paid $238,000. She collected from other drugmakers, too.

Whatever the real numbers, there’s another issue - DelBello receives grant money from the National Institutes of Health and, as Grassley noted, “universities are supposed to monitor conflicts of interest when their researchers receive NIH grants.” [Take a look at section (c)(1) and (2)]. And the NIH is also supposed to monitor conflicts, at least involving payments exceeding $10,000 over a 12-month period.

The NIH, however, is apparently loathe to do so. Last month, Norka Ruiz Bravo, the NIH deputy director for extramural research, told The New York Times that “for us to try to manage directly the conflict-of-interest of an N.I.H. investigator would be not only inappropriate but pretty much impossible.” She added that “I think (the system) is working to the extent that people are being honest and I think most people are honest.”

Whether she is aware of DelBello and her relationship with AstraZeneca is unclear. Ruiz Bravo wouldn’t return our phone call. Honestly. Nor would DelBello. Honestly. A University of Cincinnati spokesman, Richard Puff, promised to get back to us, but so far hasn’t. Honestly. We will update you with any replies. Meanwhile, one has to wonder if the system is working.

Hat tip to the WSJ Health blog

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  1. n=1

  2. The money issue aside, if you go back and look at the guidelines, this study was one of more than 100 used in the the guidelines’ development. Moreover, while Grassley (not a medical expert) called the study inconclusive, the authors and other medical experts did draw conclusions from the study–essentially saying that those children who can tolerate the drug generally benefit from its use.

    This discussion is not meant to suggest that antipsychotics are good, bad or indifferent for children–that’s one for the psychiatry and psychology communities, as well as other stakeholders to fight over. My point is simply that Grassley is grandstanding and misrepresenting the content and the importance of 1 study in order to make his point. This may be good politics, but it’s not necessarily good science.

  3. How can this ’system’ be functional if elements of the system are impure due to financial corruption?

  4. Hi Atlex,

    Fair point about the study - it was one, although it was used for developing guidelines. In any event, the weight given the study isn’t the issue, as I understand it. Rather, it was the alleged failure of the NIH and the university to monitor the relationships. Again, if I hear more, I will report back.

    Thanks for stopping by,
    ed

  5. Atlex,

    Id rather leave this isssue up to Grassley,.. than those who seek to profit from the drugging of our Nation’s Children.

    Something Carl Sagan said 20 years ago seems to apply here:

    One of the saddest lessons of history is this: If we’ve been bamboozled long enough, we tend to reject any evidence of the bamboozle. We’re no longer interested in finding out the truth. The bamboozle has captured us. It is simply too painful to acknowledge– even to ourselves– that we’ve been so credulous.

    Carl Sagan, The Fine Art of Baloney,”Parade,February 1, 1987.

  6. Obviously the woman has a conflict of interest between the people paying her and the work she is doing. It’s no secret that educators, politicians, researchers, doctors, and psychiatrists are being well paid by Big Pharma to find favorable evidence to support the drugging of men, women, children, and animals. This is just another case of Big Pharma using people in key positions to urge the use of their drugs to treat everything.

  7. Lisa

    Excellent quote.

    Ed,

    Have you heard from Uni Cin yet?

    Dont let them off the hook……I haven’t!

    I do hope Melissa has good tax records!!

  8. [...] Here’s what a fellow psychiatrist thinks of that!And it’s the place that hasn’t yet got back to Ed at Pharmalot! [...]

  9. [...] what a fellow psychiatrist thinks of that!And it’s the place that hasn’t yet got back to Ed at Pharmalot! Read [...]

  10. WHAT IS CONGRESS DOING? IT IS NOT ONLY WITH CHILDREN BUT ALSO WITH ADULTS. WE MUST HAVE TRUTH AND HONESTY IN MEDICAL HEALTHCARE. CHUCK GRASSLEY AND ALL ELECTED OFFICALS ARE DIRECTING THE MOST IMPORTANT ISSUES THAT AFFECTS OUR LIVES—HEALTH. IT IS TIME CONGRESS STOPS CORRUPTION. MEMBERS OF MY FAMILY AND MYSELF WERE AFFECTD BY THE CONDITIONS THAT EXIST IN OUR SOCIETY. LAST AUGUST I LOST MY HUSBAND,THE LOVE OF MY LIFE BECAUSE OF THE CORRUPTION AND INFLUENCE OF SPECIAL INTEREST GROUPS DIRECTING OUR LEGISLATIRES. WHEN WILL AMERICA HAVE ETHICAL HEALTH CARE LAWS? NEW JERSEY DOES CARE ABOUT IT CITIZENS. IT STARTS AT THE DOTORS OFFICE.

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