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Senate watchdog questions US grant to controversial psychiatrist

A senior US senator today asked the National Institutes of Health (NIH) to explain its decision earlier this month to award a five-year grant worth up to US$2 million to a psychiatrist who is now under investigation by the US Department of Justice and who failed to report more than $1 million in pharmaceutical-company income in the past.

In this letter, first obtained by the blog Pharmalot, Senator Charles Grassley, a Republican of Iowa, tells NIH director Francis Collins that it is “troubling that NIH continues to provide limited federal dollars to individuals who have previously had grant funding suspended for failure to disclose conflicts of interest.”

The new grant was awarded to Charles Nemeroff (pictured), the chair of psychiatry at the University of Miami in Florida, on 16 May, as Science Insider first reportedAccording to the NIH grants database, Nemeroff — who did not reply to e-mails over several days requesting comment — will use it to study the psychobiological risk factors for post-traumatic stress disorder.  The grant, from the National Institute of Mental Health (NIMH), is worth $401,675 in 2012 and will run for 5 years. Nemeroff has previously been punished for failing to report at least $1.2 million in pharmaceutical-company income.  That episode also led to a still-open US justice-department investigation of Nemeroff that is being conducted in conjunction with the Inspector General of the Department of Health and Human Services, the parent agency of the NIH.

Near the top of a list of six hard-hitting questions in the letter to Collins, Grassley asks: “Was NIH aware that Dr. Nemeroff was under federal investigation? If so, why did NIH decide to award this grant anyway?”  He adds: “Were the peer reviewers aware that Dr. Nemeroff was under federal investigation? If not, why not? Provide pertinent documents.”

In the letter, Grassley also hammers the NIH for failing to require that universities create public websites reporting on the amounts and nature of any financial conflicts of interest for their NIH-funded scientists. The agency has previously said that it would institute such a requirement when it released revamped conflict-governing rules, but it backed off from that proposal last August, and the NIH’s final rules on the matter said that institutions that choose not to establish a website can instead respond to written requests for such information from members of the public.

Grassley’s then-staffer Paul Thacker led a 2008–09 investigation of Nemeroff. It revealed that the influential psychiatrist, then a department chair at Emory University in Atlanta, Georgia, had failed to report, among other payments, $800,000 in income from GlaxoSmithKline for giving more than 250 talks to psychiatrists between January 2000 and January 2006. Later that year, he began running a $9.3-million trial of Paxil, made by GSK.

Nemeroff’s penance was declared by Emory in December 2009: the loss of his chairman’s job at Emory and a ban on applying for NIH funding for two years.  One year later, Nemeroff secured the new job at Miami, after NIMH director Tom Insel assured the dean at that university that Nemeroff would be eligible to apply for new NIH grants once in his new position.

Nemeroff’s end-run around his punishment prompted Collins to declare: “If there’s a silver lining to this [Nemeroff] story — and it’s hard to find a silver lining in a story about conflict of interest — it’s that the incident brought to light NIH grants policies that may need to be addressed.”

Collins suggested that the NIH, which was then revamping its conflict-governing rules, might need to make explicit that investigators cannot dodge sanctions by switching institutions. However, the agency did not address the issue in its revamped rules.

Asked for a comment on this last week, the NIH office of extramural research released this statement:

“As described in the preamble of the final rule on extramural financial conflicts of interest, the final rule expands Investigator disclosure to include all significant financial interests (SFI) related to their institutional responsibilities and requires public accessibility of information about financial conflicts of interest (FCOI) of senior/key personnel. Therefore, the likelihood of an institution not receiving information about a particular SFI or FCOI of an investigator transferring to that institution is minimized.”

In other words, NIH is arguing that, if the new rules — which don’t go into effect until this August — had been in place when Nemeroff moved from Emory to Miami, his new employer would have been made aware of his financial conflicts before hiring him, because it would have asked Emory for all the relevant information. Assuming, of course, that Nemeroff had reported all the relevant information. This, too, would be more likely under the new rules,  the NIH argues, because they make clear that investigators have to report all their significant financial interests to their institutions — not just those they judge to be pertinent to a given award.

That argument may not go far with Grassley, who declared in his letter to Collins that the decision to fund Nemeroff  “risks sending the wrong message to physicians seeking or performing federally funded research”.

Comments

  1. Report this comment

    Bernard Carroll said:

    Let others debate the legality and the ethics of this situation. My concern is for the quality of the science. Nemeroff plans to run this project with the help of former junior faculty colleagues at Emory University. In past studies from this group, serious questions arose about the relevance of their work to Post-traumatic Stress Disorder. Basically, they did not study subjects presenting for care with clinical diagnoses of PTSD. They rounded up a sample of convenience from the waiting areas of the public medical and obstetric clinics at Grady Hospital, administered some standard questionnaires, and bestowed a variety of psychiatric diagnoses like PTSD and depression. Yes, the subjects may have had turbulent, disadvantaged and adverse life histories (‘trauma’) and yes they may have had a variety of nonspecific symptoms, but that is a long way from a clinical diagnosis of PTSD. Whatever is found in this project seems more likely relevant to chronic stress than to PTSD, so why misrepresent it as PTSD?

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    Ally Kanamisa said:

    There is a recent post by NIMH Director: “Serving those who served” indicating that, as a result of most recent wars, there are 70,000 soldiers suffering from PTSD. It is obviously a blog and how the clinical diagnosis has been made is not mentioned.
    Given Nemeroff’’s avidity and success in getting NIH funding, it would not be surprising to see him with quick data and publications on psychobiological factors very soon. And, most likely, another major clinical type grant awarded in a couple of years. As it has happened before, clinical studies based on questionable scientific grounds. Public resources adequately utilized?. No consequences for patient safety?

  3. Report this comment

    Bernard Carroll said:

    For an expert commentary on the diagnostic question see PubMed ID 19892206.

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    Ally Kanamisa said:

    Reading Senator Grassley’s letter to Francis Collins, it comes to one’s mind an additional missing question:

    If Nemeroff was under investigation in 2010, why, how and who was responsible for his nomination and placement as Reviewer in one of the 2011 CSR Study Sections?. I believe it was June 2011 and don’t know if he ended up participating in it since there was public expression of concern. This is important to know in order to understand NIH operations. It is difficult to believe that NIH was not aware of his being investigated (considering that NIH is an integral part of the HHS Department).

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    Theresa Defino said:

    Grassley’s office sent this as a press release. Pharmlot doesn’t deserve props.

  6. Report this comment

    Ally Kanamisa said:

    Dear Web Admin,

    Thank you for alerting me that “ I have hidden your comment as another user reported it as not in line with our commenting guidelines. Please do post again excluding these sections of your post”.

    I am not aware that any section of my post is not in line with your commenting guidelines but I accept your decision.

    Sincerely,

    AK

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