Oct. 6

More Scrutiny on Conflicts of Interest

Emory University announced Friday that Charles Nemeroff, a leading research on depression, was stepping down as chair of the psychiatry department, pending an investigation of allegations that he may have violated university and federal regulations about conflicts of interest.

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The charges came from Sen. Charles Grassley of Iowa, who has used his position as senior Republican on the Senate Finance Committee to probe allegations of conflict of interest against a number of prominent biomedical researchers. The committee has oversight over many federal health programs and Grassley has charged that universities and the National Institutes of Health are not enforcing regulations designed to prevent conflicts of interest in federally financed research, especially about drugs.

Grassley’s allegations against Nemeroff included considerable detail about reports Nemeroff made to Emory and apparent contradictions that amounted to more than $1.2 million in unreported income from drug companies at a time that Nemeroff was receiving federal research grants. Grassley detailed the apparent discrepancies in a statement in the Congressional Record. He noted that the theory behind reporting requirements is that they assure “a level of objectivity in publicly funded research, and state in pertinent part that NIH investigators must disclose to their institution any ’significant financial interest’ that may appear to affect the results of a study.”

In numerous instances, Grassley charged, Nemeroff filed reports or responded to questions that significantly understated the extent of his ties to pharmaceutical companies — in particular GlaxoSmithKline — that were paying him while he was conducting federally funded research dealing in part with the treatment of depression. Because many new drugs to treat depression are controversial, Grassley and others have said it is essential that federal tax dollars support research that cannot be clouded by conflicts of interest.

Grassley noted that in October 2003, Nemeroff answered questions from Emory on his ties to GlaxoSmithKline by saying that he was paid to chair an advisory board “2-3 times per year and I am paid per board meeting at a standard rate of $5K per weekend.”

In fact, instead of receiving $15,000 from the company, he was paid $119,000 in speaking fees and expenses — directly related to his promoting specific drugs, Grassley said.

Similarly, in 2004, Nemeroff again reported receiving $15,000 a year for attending advisory board meetings, but left out payments for speeches at which he promoted the company’s drugs — generally for $3,500 per talk. Grassley also provided evidence that Emory committees found that Nemeroff had been violating reporting requirements and complained about this, only to have him promise he would improve, but without the university making sure this actually happened.

Nemeroff is not responding to requests from reporters for comments. But his internal e-mail messages — published by the blog Pharmalot — suggest that he has been frustrated both by the inquiries into his ties to drug companies and the resulting reporters’ questions.

Emory’s statement quoted Nemeroff as telling the university: “To the best of my knowledge, I have followed the appropriate university regulations concerning financial disclosures. I have dedicated my career to translating research findings into improvements in clinical practice in patients with severe mental illness. I will cooperate fully and work with Emory to respond to the alleged conflicts of interest issues raised by Senator Grassley and his staff.”

The university said that Emory officials take “this matter very seriously and are working diligently to determine whether our policies have been observed consistently with regard to the matters cited by Senator Grassley.” The university added that “the length and complexity of the history outlined by Senator Grassley will require careful review of underlying payment records from the pharmaceutical companies, which we have requested from Senator Grassley’s office. We have also requested that Dr. Nemeroff provide us with relevant information and documentation so that we will have all the facts before us.”

The university statement concluded: “Emory is committed to maintaining strong conflict of interest policies and procedures and will conduct a fair, thorough, and evenhanded investigation of these claims.”

For research universities, the Grassley probe — which has also exposed ties between prominent researchers at Harvard and Stanford Universities to drug companies — has been frustrating. Generally, universities have argued for better self-regulation as the key to preventing conflict of interest. But as more incidents have surfaced, some university lobbyists have moved toward accepting that there may be a need for more federal oversight as well.

— Scott Jaschik

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