A Leader of Ethics Reform at NIH Seems to Think the Rules Don't Apply to Him

Now in the news is a controversial decision by Dr. Thomas Insel, a top official at the National Institutes of Health (NIH), to help Dr. Charles Nemeroff get a new job and a new NIH grant. Dr. Nemeroff, while at Emory University, was one of the most blatant violators of the NIH's financial conflict-of-interest (COI) policies. Today we examine a striking piece of Dr. Insel's history that throws light on his recent decision. First, let's start by recapitulating the story thus far.

Dr. Insel had a triple role in the current story:

• He is the Director of the National Institute of Mental Health (NIMH), one of the larger institutes within the National Institutes of Health.


• As the NIMH Director he provided substantial help to Dr. Charles Nemeroff in the latter's efforts to find a new place to work and to obtain NIH funding again for his research.


• On top of this, Insel is a leader of the current, well-publicized efforts to raise NIH's standards of ethical conduct. Specifically, he is helping devise a new set of conflict-of-interest rules that will apply to the many tens of thousands of medical researchers funded by the NIH in its extramural program.

Paul Basken, writing in The Chronicle of Higher Education, notes that the "actions by Dr. Insel, during a period of heavy Congressional pressure on the NIH to institute reforms, raise new questions about the NIH's stated commitment to attacking the problem of financial conflicts of interest in taxpayer-financed medical research."

The Health Care Renewal blog has harsher words:

"The unraveling of Thomas Insel, MD, Director of the National Institute of Mental Health continues. His ties with the poster boy for conflict of interest in psychiatry, Charles Nemeroff, MD, are getting new exposure. The story is notable not only for what it says about Insel and Nemeroff, but also for what it says about the ethical culture within NIMH."

The writer refers to the "appearance of hypocrisy within NIH, with Insel leading an NIH initiative for strengthening ethics rules for medical researchers."

Insel has issued a remarkable statement entitled "NIMH — Reducing Conflict of Interest, Ensuring Public Trust," which he posted on June 7. Although this statement was posted one day after the Chronicle article appeared and was presumably triggered by this article, it avoids all the serious issues raised in the Chronicle article about Insel's support of Nemeroff—it doesn't even mention them. Dr. Insel seems unaware of the cloud of ethical lapses hanging over his own head. Meanwhile Senator Chuck Grassley (R-IA) has written the Inspector General of Health and Human Services: "I was extremely disturbed to read a story today in The Chronicle of Higher Education.... I ask that you look into this matter and proceed as you deem appropriate." (A Nature blog post contains a link to this letter)

And now we arrive at another incident that occurred while Insel was Director of NIMH—one involving a different perpetrator, a medical researcher in the NIH's intramural program. Dr. P. Trey Sunderland was the head of an NIMH research group that studied Alzheimer's disease. In December 2006 he pleaded guilty in a federal court to a criminal conflict of interest created by payments to him of almost $300,000 from a drug company for work related to his NIMH research. In his opening statement at a House hearing in September 2006, Representative Joe Barton noted that Dr. Insel, as the Director of NIMH, had recommended a $15,000 retention bonus for Sunderland in January 2006, at a time when Sunderland's COI violation was already well known. (The retention bonus is an optional government payment whose purpose at NIH is to attract and retain physicians.) Representative Barton mentioned additional optional benefits provided by the NIMH to Dr. Sunderland after his violations of the NIH's COI rules were discovered and confirmed.

The NIH is trying to improve its ethical standards—and repair its damaged public image—by tightening the rules on financial conflicts of interest. POGO asks: Is it appropriate for Dr. Insel to lead this effort? NIH Director Francis Collins should deal with this question promptly and publicly. It's a problem that should be easy to fix.

-- Ned Feder

Comments

[John M. Nardo MD]

Dr. Charles Nemeroff assaulted those of us around the Department at Emory with his 'Drug Culture' and unethical career for two decades. Now, the director of the NIMH has aided him in moving on to another unsuspecting pasture - Miami. In 2008, Dr. Bernie Carroll famously said, "... Dr. Nemeroff is so compromised by now that he has lost effectiveness as a front man for Pharma. Indeed, he is so toxic that he now glows in the dark." But Dr. Nemeroff is attempting to rise from the ashes. Charlie Nemeroff is no Phoenix, that is assured. Let's hope that the current brouhaha is enough to spare Miami what Nemeroff put us through here in Atlanta.

[Bob Olcott]

It's no wonder our "mental health" system is a disaster.
We just had a local (Dartmouth) psychiatric researcher-who was recently "acquitted" in Federal Court, of ethics/misappropriation of funds, ask for his old job back, at the Veterans Administration in White River Junction, Vt., and that matter is still "pending". I applaud Senator Grassley for his continued efforts, on behalf of all taxpayers, and POGO for their well needed vigilance!