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Charles Nemeroff
University of Miami medical school psychiatry chair


Pharmalot
NIH Insists Latest Nemeroff Grant Is Kosher

By Ed Silverman
August 13th, 2012

Three months ago, US Senator Chuck Grassley demanded that the National Institutes of Health justify a recent decision to award a multi-million-dollar research grant to Charles Nemeroff, the University of Miami medical school psychiatry chair, who has been at the center of a far-reaching probe into conflicts of interest involving academic researchers and the pharmaceutical industry. The grant is for research into post-traumatic stress disorder.

As we reported previously, the grant was made three years after the former Emory University psychiatry department chair was sanctioned for failing to disclose that he had accepted $1.2 million in payments from GlaxoSmithKline. At the time, he was also the primary investigator for a National Institutes of Health study of the Paxil antidepressant, which is sold by the drugmaker.

And as we have noted, those details emerged thanks to a Grassley investigation into undisclosed conflicts over concerns that such relationships may unduly influence medical research and practice. In response, the NIH suspended a $9.3 million, five-year grant that Nemeroff held for a depression study at Emory and the university barred him from applying for NIH funding for two years. Nemeroff later accepted a job at the University of Miami.

Not surprisingly, Grassley was angered by the grant, especially since his probe was later extended to the National Institute of Mental Health after director Tom Insel assured the University of Miami that Nemeroff would again be eligible for research grants. But the NIH insists the grant is kosher. In an August 3 letter, NIH Deputy Director Lawrence Tabak writes Grassley that “I want to assure you that all procedures have been followed carefully in the process of awarding this specific grant to the University of Miami.”

“As with all NIH applications, the application from the University of Miami was evaluated for scientific and technical merit through the NIH peer review system,” he wrote Grassley. He maintained the process included vetting Nemeroff for any financial conflicts of interest and that NIH reviewers also checked with University of Miami officials to ensure the school complies with applicable regulatory requirements. And he noted that Insel recused himself from the review. Instead, NIH Deputy Director for Extramural Research Sally Rockey made the final decision to award the grant.

However, Tabak added that NIH reviewers were unaware of an investigation into Nemeroff and his Emory grants by the US Department of Health & Human Services Office of the Inspector General, which is working with the US Department of Justice. The OIG probe has been completed, according to Grassley, but it is not known whether the DOJ will take action before releasing the report. Tabak says such probes are confidential, which is why NIH reviewers were unaware.

The NIH, however, was keenly aware that the grant was likely to cause a stir and, as part of the request Grassley made for documents relating to the review, the agency released so-called talking points – a primer on how to answer questions. Their existence indicated a level of concern that the grant would generate questions given that Nemeroff has been such a controversial figure over the past few years.

The two-page talking points notes that the NIHM did not plan to release a statement about the latest Nemeroff grant and the responses to hypothetical questions often closely resemble some responses in the August 3 letter to Grassley. As an example, the agency stresses the need for further research into post-traumatic stress disorder and refers to the “magnitude of national traumatic events,” such as the 2011 terror attacks and the Iraq and Afghanistan wars.

“If successful, the findings from this study will help in our efforts to develop predictive, personalized, and preventative approaches to PTSD, a major public health problem, and for the armed services, a national security challenge,” according to the talking points and Tabak letter.