Doctor Nemeroff Didn't Disclose Glaxo Payments - of a mere $500,000 - Grassley Says

I guess he forgot.

After all, what's half a million dollars? Just pocket change. (Dr. Nemeroff, can this poor journalist have some? I take charity.)

Doctor Didn't Disclose Glaxo Payments, Senator Says

Wall Street Journal
Oct. 4, 2008

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.

Dr. Nemeroff has been a protagonist in numerous Healthcare Renewal pieces before. $500,000 is just part of the windfall:

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.

So there has been trouble in the past. Why is this a "special" problem?

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.

(10/7 Correction: It appears the WSJ was incorrect and that the budget was $3.95 million, as reported by other sources such as the NY Times.)

I can imagine - hypothetically speaking, of course - that such sums might causes academic leaders to turn a "blind eye" to violations of certain rules and regulations regarding disclosures of industry payments and conflicts of interest by faculty ... just sayin' ....

What is happening in the interim?

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.

Voluntarily stepped down? What other choice was there, I ask? That's akin to saying the Axis countries voluntarily surrendered in WW2...

There seems to be a pattern:

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.

In my estimation, a number of issues need to be addressed if Sen. Grassley's latest allegations are true:

• At the very least, Dr. Nemeroff needs to find himself "persona non grata" in the halls of industry-sponsored drug talks, financial disclosures or not; trust is easily broken, but very hard to repair, and:
  
• The $3.95 million Emory-GSK-NIMH Collaborative Mood Disorders Initiative examining GSK drugs needs to be dissected not just with a fine-toothed comb, but also a scanning electronic microscope for evidence of conflict of interest-mediated biases, tampering, and other potentially invalidating shenanigans.
• Were these payments declared to the IRS and applicable state(s) regarding income taxes?
  

Again, if these allegations are true, this would be a brazen, egregious breach of trust that could rank as one of the largest biomedical research conflict-of-interest scandals, ever.

-- SS