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U.S. to Probe Emory, Nemeroff

By Tiffany Han Posted: 03/07/2009
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The federal government may investigate former psychiatry chairman Charles B. Nemeroff’s consulting activities to gauge whether he fulfilled his required time commitments as chief investigator of multiple research grants from the National Institutes of Health (NIH).

Sen. Charles Grassley (R-Iowa), the ranking Republican on the Senate Finance Committee, sent a letter to the inspector general of the U.S. Department of Health and Human Services (HHS), prodding him to investigate the conflict-of-commitment matter. The letter, made public on Feb. 24, also questioned whether Emory reported conflict-of-interest issues to the NIH in good faith.

When faculty apply for federal grants, which are a contract between the agency and the University, they request a salary amount in return for committing a percentage of their time to the research effort. Grassley charged in the letter that Nemeroff could not have fulfilled his commitments to the NIH “while, at the same time, spending hundreds of days on the road giving promotional talks for, among others, drug companies.” The NIH declined to comment.

The Office of the Inspector General (OIG) is prohibited by law from confirming or denying a possible investigation and cannot comment on cases that may be underway.

A spokesperson for Grassley’s office said the Feb. 24 letter was a form of public declaration that an investigation would be conducted. The spokesperson said Grassley’s office has been in discussions with the OIG since December.

Emory’s general counsel, Kent Alexander, said the University has not received word from the inspector general on whether any investigation would take place. He said the University was not aware of the Feb. 24 letter until a Wall Street Journal reporter contacted Emory about it earlier this week. Since then, Emory has begun taking a close look at past records relating to these new allegations, Kent said.

“We are taking all of this very seriously,” Alexander said. “Whether they pursue it or not, we’re certainly looking into it.”

Alexander said the University’s own review could take an unspecified amount of time, adding that “the important thing is to be thorough, accurate and fair.”

The University already conducted an internal investigation last fall after Grassley alleged that Nemeroff had misreported outside income and violated University and federal conflict-of-interest policies by exceeding limits set on outside consulting and speaking engagements. From 2003 to 2008, Nemeroff served as the primary investigator on a $3.9 million joint grant between Emory, the NIH and pharmaceutical giant GlaxoSmithKline (GSK). Grassley alleged that Nemeroff received more fees from GSK than the maximum amount allowed.

The in-house investigation focused on documents from 2000 to 2006 provided by GSK, the largest single payer, and led to a Dec. 5 press release that said Nemeroff had received at least $800,000 in unreported outside income. Nemeroff stepped down as chairman in December but has continued in his teaching post; he is barred from participating in any sponsored research grants for the next two years at least.

In a Dec. 22 statement, Grassley commended Emory’s “swift and sure-footed response” in dealing with the conflict-of-interest allegations, adding that the University has set an example for other research institutions to follow and for the NIH to “hold up as the kind of standard it expects from those receiving federal research dollars.”

But in the Feb. 24 letter, Grassley questions whether Nemeroff’s talks were “focused on substantive medical educational topics” that were not “product specific or promotional,” as the University had asserted in its Dec. 5 statement. University officials have said that a review of lecture slides and interviews with presentation attendees corroborated Nemeroff’s assertion that his conflicts of interest were purely financial and did not affect his research or judgment regarding patients.

Based on information that was made public last fall, Grassley states in his letter that Nemeroff was a guest speaker who trained PsychNet doctors in the advocacy of GSK’s Paxil product. PsychNet is a program created by GSK to train doctors in promoting Paxil. According to public documents, Nemeroff served in this capacity in 2000.

University President James W. Wagner said the “real thrust of this [new investigation] was to question the conflict of commitment, which is something, very frankly, we need to look into.”

He said the University will look at whether Nemeroff was overcommitted in time to the University, the NIH and GSK.

“We have an ethical obligation, now that this matter has been brought, to understand the facts better, and we will, whether or not there is an investigation by the OIG,” Wagner said.

The inspector general, currently Daniel R. Levinson, leads investigations to ensure that federal programs under the HHS are run properly.

Don White, a spokesperson for the OIG, said that after any investigation, the office presents its findings but does not act on them. Any possible legal or administrative action would be brought by a legal office or the involved federal agency, he said. White said that while he cannot comment on whether an investigation is taking place, there is no timeline for a typical investigation.

— Contact Tiffany Han.

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