Saturday, October 04, 2008

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


D Bunker said...

With bubbles like this breaking the NIH bathwater, I'm sore afraid that that fine tooth comb and electron microscope are about the Last implements the public can expect to see applied to the problem.

From the NYT

“For us to try to manage directly the conflict-of-interest of an N.I.H. investigator would be not only inappropriate but pretty much impossible,” said Dr. Norka Ruiz Bravo, the institutes’ Deputy Director for Extramural Research.

The health institutes awarded more than $23 billion last year through over 50,000 competitive grants to more than 325,000 researchers at over 3,000 universities. Each grant typically underwrites only a part of the cost of the research at issue.

Indeed, academic medicine has become so rife with conflicts of interests in recent years that the Food and Drug Administration has complained that it has difficulty finding experts for its advisory boards who do not have a conflict."

Inappropriate? Impossible? For $23 Billion?

Couple that with the FDA collecting $500 Million in what it euphemistically terms "User Fees" from drug and med. device manufacturers, and uh, ..... well, ..... it looks like we're going to be seeing a whole bunch More of these Homer Simpson "Doh!" moments, for decades to come.

Anonymous said...

I think you mean "persona non grata."

Gaby de Wilde said...

This reminds me of that plan to insert video screen commercial breaks into classes.

It souds unbelievable but they already have busradio in some school buses.

O my.. got commercials?

Anonymous said...

One does not have to look far to see how this type of situation can exist in a university setting. The Akron Beacon journal reprinted two stories from the Columbus Dispatch concerning staff salaries. The Sept. 28 story OSU president expands circle of top advisers highlight the increase from $2.8M to $5.7M in salaries for executive advisors since the return of Gordon Gee. These salaried individuals are earning $300,000+.

This is all justified with this quote: Through a similar effort at Vanderbuilt University in Tennessee, Gee was able to raise $1.75B (yes BILLION) two years ahead of schedule, increase the school's endowment by nearly 50 percent and almost double the funding for academic research, he said.

On Oct. 1, we have this followup: Ohio State president named to fourth corporate board. Gee became involved with a conflict when he returned to OSU due to a position held by a local corporation on a board. What is important is that: Last year, Gee earned a total of $501,739 as a director of Gaylord, Hasbro and Massey. He makes $1 million a year as Ohio State president.

But the OSU board has been discussing a new contract for Gee that will spell out additional compensation. Cloyd said last month that the proposal would allow private donors to contribute to Gee's compensation, and that the deal would keep him among the nation's highest-paid university leaders.

How can we expect university staff and students to behave in an ethical manor when we a university president who will now receive compensation from "private donors." How can we except executive oversight when they are receiving some of the highest salaries in an economically depressed area? How ethically can we expect the medical school, or any part of this university, to behave given this leadership?

All hail the might dollar!

Steve Lucas