U.S. Probes Emory Doctor's Glaxo Ties

By DAVID ARMSTRONG

Federal officials are investigating Emory University to determine if the school misled the National Institutes of Health about its star psychiatrist's lucrative consulting work for big drug makers, people familiar with the matter said.

The probe by the inspector general for the Health and Human Services agency, which investigates fraud in NIH programs, concerns the work of Charles Nemeroff. From 2003 until last year, Dr. Nemeroff served as primary investigator on an NIH-funded research effort to study five GlaxoSmithKline PLC drugs for use as antidepressants. During that time, Dr. Nemeroff also received hundreds of thousands of dollars from Glaxo.

A person familiar with the federal probe said investigators are examining whether Emory failed to tell the NIH about Dr. Nemeroff's potential conflicts of interest in conducting the research, and whether the university may have misrepresented the kind of work he did for Glaxo.

Sen. Charles Grassley had been pushing for such a probe, and the Iowa Republican wrote a letter to the inspector general dated Tuesday. Mr. Grassley provided his letter to investigators along with new information about the relationship between Dr. Nemeroff and Glaxo.

Mr. Grassley has been pushing the NIH to be more aggressive in policing conflicts of interest among university researchers who collectively receive billions of dollars in federal grants each year.

A spokeswoman for the inspector general said the senator's letter was "being reviewed closely," but declined to comment on whether the office is investigating the matter. Emory said it has been cooperative with the NIH and will continue to be so. Glaxo said the company is cooperating with Mr. Grassley's efforts. A call to Dr. Nemeroff wasn't returned, but in the past the doctor has said he believed he complied with relevant disclosure requirements. A spokesman for the NIH also declined to comment.

The NIH requires universities to report potential conflicts of interest to the agency and to ensure research is carried out objectively.

Schools that violate those policies could face sanctions, ranging from fines to a freeze on funding. Emory received $251 million in NIH grants last year, more than half of all the Atlanta school's outside research funding.

An Emory investigation of the matter in December concluded that Dr. Nemeroff failed to report more than $800,000 he received from Glaxo from 2000 to 2006. Dr. Nemeroff stepped down as chairman of the psychiatry department and the school said it wouldn't submit any research requests to the NIH involving Dr. Nemeroff for at least two years.

Dr. Nemeroff, according to the school, said he didn't believe it was necessary to report the payments because they weren't for "product specific" work but rather for talks on general medical topics. The university said he still should have reported the payments, but agreed with his contention that his consulting work wasn't promotional.

Records obtained by Mr. Grassley show that Dr. Nemeroff played a role in a Glaxo program that was established to aggressively promote the British company's top-selling antidepressant, Paxil.

Glaxo described this "PsychNet" program in an internal 2000 document as "an ideal way for key opinion leaders to influence clinicians...on the benefits of Paxil versus competitors" and to train doctors to "help build Paxil advocacy."

Dr. Nemeroff was listed as one of two speakers at a March 2000 session in Naples, Fla., to train doctors "on the efficacy of Paxil and the PsychNet presentations." Doctors were paid $2,500 per talk and required to sign agreements barring them from saying how much they were paid or sharing materials Glaxo provided.

Write to David Armstrong at david.armstrong@wsj.com