Senator Says Emory Psychiatrist Didn't Disclose $500,000 in Payments from GSK !!

Senator Says Emory Psychiatrist Didn't Disclose $500,000 in Payments

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A prominent Emory University psychiatrist failed to tell the school about $500,000 in payments from drug maker GlaxoSmithKline while he was serving as the primary investigator for a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged.

The payments to Charles Nemeroff, the chair of the Atlanta university's psychiatry department, were mainly for his work speaking to other doctors across the country about Glaxo drugs, including its big-selling anti-depressant 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. The Iowa Republican is the ranking minority member of the Senate Finance Committee, which is responsible for federal outlays for government health insurance programs.

A financial relationship is considered significant by Emory and other schools if the researcher is paid more than $10,000 a year, and Emory instructed Dr. Nemeroff not to exceed that amount, the records cited by Sen. Grassley indicate.

Dr. Nemeroff has been put in the spotlight before over his financial ties to the medical industry. In 2006, he stepped down as editor of the journal Neuropsychopharmacology after The Wall Street Journal reported he wrote a favorable review in the journal of a new device for treating depression but didn't disclose his financial ties to the device's maker. The review concerned a small device from Cyberonics Inc. that is implanted in the chest and delivers mild electrical pulses to the vagus nerve in the neck.

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 government agency that is part of the National Institutes of Health. Sen. Grassley wrote that the NIH budgeted $3.95 million for the project with about $1.35 million paid directly to Emory for overhead costs. He said that Dr. Nemeroff apparently received some payment for his salary from the grant, although the specific amount is unknown.

The research effort, called the Emory-GSK-NIMH Collaborative Mood Disorders Initiative, examined five Glaxo drugs considered for use as possible antidepressants. GSK stands for GlaxoSmithKline. The NIH requires that universities police their academics to avoid financial conflicts of interest.

Emory, in a statement, said the allegations made by Sen. Grassley are "serious" and that the university is "working diligently to determine whether our policies have been observed consistently with regard to the matters cited" by the senator. Dr. Nemeroff did not return a call to his office. But the university said it had spoken to Dr. Nemeroff, who told the school that "to the best of my knowledge, I have followed the appropriate university regulations concerning financial disclosures."

Glaxo, in a statement, said it has "rigorous guidelines governing our interaction with healthcare professionals who participate in GSK-supported speaking events," and that it requires them to "proactively disclose" these relationships.

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The senator alleges Dr. Nemeroff did not report that he was giving promotional talks for Glaxo on the anti-depressant Paxil.

When questioned by Emory officials, Dr. Nemeroff apparently failed to report all of his ties with Glaxo's speaker's bureau, the Sen. Grassley 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."

In 2003, however, Sen. Grassley said records show 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 did not 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 records cited by Sen. Grassley.

A week later, in two days of work, he exceeded that limit, according to records provided the senator. He saif 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 at the Larkspur Restaurant and Grill in Las Vegas; and that on the next day, hje was paid $7,000 for two talks he gave for Glaxo.

The university required annual payments from Glaxo had to be limited to $10,000 as long as he was involved in the government collaborative studying Glaxo drugs, according to university records cited by Sen. Grassley.

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-of- interest committee, "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. GSK has been informed of this change and certainly understand the reasons for this decision and is supportive of my compliance with the university recommendations."

But according to Glaxo records, Dr. Nemeroff exceeded the $10,000 limit that month. The payments included a $3,500 fee for a teleconference with the Louisiana State University Psychiatry Department; talks on Paxil at two restaurants in New York —the Passion Fish Restaurant in Woodbury and Burton and Doyles in Great Neck – that paid a total of $7,000; and a $3,500 payment for another teleconference.

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." In all, Sen. Grassley said Dr. Nemeroff apparently failed to report about a half million dollars in fees and expenses from Glaxo for dozens of talks he gave to promote the company's drugs.

Emory said it has asked Sen. Grassley for copies of the records he cited and promised a "fair, thorough, and evenhanded investigation of these claims."