A prominent Emory University psychiatrist failed to tell the school about $500,000 he received from drug maker GlaxoSmithKline PLC while heading a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged.The payments to Charles Nemeroff, chairman of the Atlanta university's psychiatry department, compensated him for making presentations to doctors about Glaxo drugs, including its big-selling antidepressant Paxil, according to records Sen. Grassley obtained from Emory and Glaxo. The senator made the allegations in a letter to Emory President James W. Wagner dated Thursday.
In correspondence with Emory officials who police conflict-of-interest issues, Dr. Nemeroff repeatedly denied having a significant financial relationship with Glaxo, according to the records cited by Sen. Grassley, an Iowa Republican who has been investigating ties between academic researchers and the medical industry.
Federally sponsored research, including work Dr. Nemeroff did, is supposed to be free of financial conflicts, but enforcement is generally left to universities, which seldom act against prominent researchers. Emory instructed Dr. Nemeroff not to take more than $10,000 a year from Glaxo -- its conflicts threshold -- but he exceeded that amount, Sen. Grassley said.
From 2000 through 2006, Dr. Nemeroff received just over $960,000 from Glaxo, but reported to Emory that he received no more than $35,000, the letter said.
Dr. Nemeroff has been in the spotlight before over earnings from the medical industry. In 2006, he stepped down as editor of the journal Neuropsychopharmacology after The Wall Street Journal reported he wrote favorably in the publication about a depression-treating device but didn't disclose he was a paid consultant to its maker, Cyberonics Inc.
In a June 2004 Emory report obtained by Sen. Grassley, the school concluded Dr. Nemeroff had committed violations of its conflict-of-interest policies. At the time, he had consulting arrangements with about a dozen companies, including Merck & Co., Bristol-Myers Squibb Co. and Eli Lilly & Co.
Sen. Grassley's probe has alleged discrepancies in reporting by researchers at Harvard and Stanford universities and elsewhere. He has sponsored legislation that would force drug companies and medical-device makers to publicly disclose all payments to doctors.
Dr. Nemeroff served from 2003 until this past summer as the primary investigator on a collaborative grant between Emory, Glaxo and the National Institute of Mental Health, a federal agency. The research effort, called the Emory-GSK-NIMH Collaborative Mood Disorders Initiative, had a $3.95 billion budget from the government, and examined five Glaxo drugs considered for use as possible antidepressants.
In a statement, the NIH said Emory was investigating the concerns raised in the letter and said it "will take all appropriate action to ensure compliance." The agency said it will also be considering changes to its conflicts policies.
Friday evening, Emory released a statement saying that "in view of the ongoing internal and external investigations into these allegations," Dr. Nemeroff had voluntarily stepped down as chairman of the department, pending resolution of the issues.
Earlier in the day, Emory called the allegations made by Sen. Grassley "serious" and said it was "working diligently to determine whether our policies have been observed consistently." Dr. Nemeroff didn't return a call to his office. The university said he has told the school that "I have followed the appropriate university regulations concerning financial disclosures."
Glaxo said it has "rigorous guidelines governing our interaction with healthcare professionals" who speak at its events, and requires them to "proactively disclose" these relationships.
The senator alleges Dr. Nemeroff didn't report that he was giving promotional talks for Glaxo regarding Paxil. When questioned by Emory officials, Dr. Nemeroff apparently failed to report all of his ties with Glaxo's speaker's bureau, the Grassley letter said, citing an Oct. 1, 2003, email in which Dr. Nemeroff described his outside activities to the school:
"I have to dig up the agreement and send it to you, GSK no standing contract, I chair their ad board 2-3 times per year and I am paid per board meeting at a standard rate of $5K per weekend."
However, Sen. Grassley said records show that in 2003, Dr. Nemeroff was an active member of Glaxo's speaker board and was paid $119,000 in fees and expenses. The senator alleges Dr. Nemeroff didn't report that he was giving promotional talks for Glaxo on Paxil and another drug, Lamictal, a medication often used to treat bipolar disorder.
On March 19, 2004, the senator said, Dr. Nemeroff addressed questions from Emory's Conflicts of Interest Committee in a letter in which he wrote: "Apart from speaking at national symposia, such as the American Psychiatric Association, for which GSK might serve as a sponsor, my consultation to the company is limited to chairing their Paroxetine Advisory board and for that, I am remunerated $15,000 per year." Paroxetine is the chemical name for Paxil.
Just three days earlier, however, Glaxo paid Dr. Nemeroff $3,500 for a talk he gave on Paxil in Orlando, Fla., Sen. Grassley alleges.
The next day, March 17, he gave another $3,500 talk about Paxil in Kissimmee, Fla. In the week after writing to the conflict-of-interest committee, Dr. Nemeroff gave three talks on Paxil, for $3,500 each, at various locations in New York, according to the senator.
On July 6, 2004, Dr. Nemeroff promised the university he would limit his consulting work to Glaxo to under $10,000 a year, according to Sen. Grassley. But a week later, in two days of work, he exceeded that limit, according to records provided by the senator. He said that on July 12, 2004, GSK paid Dr. Nemeroff $3,500 in fees and $505.40 in expenses for a talk he gave on Paxil in Las Vegas; and that he was paid $7,000 for two talks he gave for Glaxo the next day.
In an Aug. 4, 2004, letter to a university dean, Dr. Nemeroff said he had "taken the necessary steps to be in compliance with the recommendations" of the Emory conflicts panel, "namely my consulting fees from GSK will be less than $10,000 per year throughout the period of this NIH grant, its renewals and final collections of data." He said Glaxo had been informed of the step and was supportive.
But according to Glaxo records, Dr. Nemeroff exceeded the $10,000 limit that month.
The Paxil talks for Glaxo continued until at least January 2006. It appears the university questioned Dr. Nemeroff's Glaxo relationship later that year, in November. In response to that questioning, Sen. Grassely says Dr. Nemeroff wrote that any suggestion he had a financial relationship with Glaxo is "absolutely untrue."
By: David Armstrong
Wall Street Journal; October 8, 2008
