Tougher NIH rules about financial conflicts in danger of being watered down

I realize this is the dead of summer and every journalist who isn’t on vacation is captivated by the Murdoch phone-hacking scandal. But while everyone is looking the other way, the National Institute of Health’s proposed new rules about the disclosure of financial conflicts of interest may be watered down.

The sticking point, according to the Project on Government Oversight (POGO), is a proposed rule that would require government-funded researchers to publicly disclose potential conflicts of interest to consumers. POGO officials say that the Office of Management and Budget (OMB), which has been reviewing the proposed changes for months, may weaken or eliminate the public disclosure requirement due to pressure from industry and university officials. In a letter to OMB July 11, POGO’s executive director Danielle Brian and staff scientist Ned Feder called on the OMB to make sure that requirement remains in the new guidelines.

Why does this matter? Because it’s vitally important for consumers to know if researchers and doctors’ judgments are being swayed by industry largesse or other conflicts that could influence their work. One would think the federal agency that supports most medical research in this country (National Institutes of Health) would be playing a key role in making such conflicts of interest transparent. Think again. Even though current NIH guidelines calls for universities to report to the granting agency significant financial conflicts (more than $10,000 annually) among faculty who have NIH grants, neither the institutes nor the universities have bothered to adhere to these 16-year-old guidelines.

Case in point: Dr. Helen Mayberg, a neurologist at Emory University School of Medicine, and a principal investigator on five federally funded research projects. As I’ve blogged about before here and here, since she came to Emory in 2003, Mayberg has earned tens of thousands of dollars consulting for medical device companies and being an expert witness in death penalty cases, always on the side of prosecutors bent on execution. Mayberg was one of eight authors of a 2006 study who failed to disclose consulting ties with Cyberonics, the maker of the electronic device their paper touted as being effective in treating depression. Because of this egregious failure to disclose, the lead author of the study, Dr. Charles Nemeroff, then chair of psychiatry at Emory, was forced to step down as editor in chief of the journal Neuropsychopharmacology, which published the paper — see background here.

Mayberg has also attracted notoriety for testifying (always for the prosecution) in more recent death penalty cases than almost any other doctor in the country. Mayberg’s job in these cases is to raise doubts about the validity of scans that show brain damage in defendants on death row, and critics say her testimony often contradicts her own published research on brain scans. But she earns a pretty penny doing so. According to a psychiatrist who also testifies in such cases, Mayberg probably earns more than $50,000 per case. In 2009, she acknowledged testifying in at least five of these cases, which potentially adds up at least $250,000 in one year alone.

These are significant conflicts of interest that Emory should have reported to the NIMH, especially since Mayberg took over as principal investigator on two major studies that used to be led by Nemeroff: the mood and anxiety disorders initiative, a collaboration between NIMH (which put up $2.1 million last year alone) and GlaxoSmithKline, to develop a new generation of antidepressants, and another $1.8 million study called predictors of antidepressant treatment response. After Nemeroff stepped down from these NIH-funded projects in the wake of his own failures to disclose, the NIH instituted tighter rules on approving grants to Emory, including more documentation on researchers’ outside activities and potential conflicts of interest, according to The Atlanta Journal-Constitution.

Yet according to NIMH records obtained under the Freedom of Information Act, “no financial conflicts of interest were identified to NIMH by Emory University about Dr. Helen Mayberg with regard to NIH-funded research projects in which she is listed as the principal investigator.” It doesn’t look like the NIH has enforced its own tougher requirements in the wake of the Nemeroff affair. All I could get out of an NIH spokeswoman was this: “NIH will neither confirm nor deny matters relating to compliance which may be under review.” Does that mean the failure of Emory to disclose Mayberg’s myriad conflicts is under review? The NIH won’t say.

This is precisely why we need a public disclosure requirement in the new regulations governing scientific conflicts of interest. Taxpayers have a right to know what their publicly funded investigators — in the case of Mayberg, someone who is in charge of millions of dollars in grants — are up to.

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