plausible deniability is neither a medical nor a scientific standard…

Posted on Tuesday 29 June 2010

I have been obviously fixated on the story of Dr. Charles Nemeroff, the former Chairman of Psychiatry at Emory University who was removed in late 2008 after he failed to disclose numerous ties with the Pharmaceutical Companies that manufacture drugs he recommended or was in charge of investigating. While chiding him for not revealing these lucrative drug company connections, Emory found no evidence that his research was biased [Emory Announces Actions Following Investigation].

That is, of course , and absurd conclusion. It’s not even the right question to be asking. If Dr. Nemeroff was being paid to be on the advisory board and speaker’s bureau, and kept the extent of his payment secret, and continued as a primary investigator on projects testing  their drugs, that is  more than enough to say that he was biased. If he’d been honest about the extent of his involvement with the drug company, he would never have gotten the grant to do the study in the first place. To me, his dishonesty up front renders Emory’s conclusion untenable – actually, inconceivable. But that’s obvious.

Speaking of untenable conclusions. To everyone’s amazement, Dr. Nemeroff was selected as Chairman at the Miller School of Medicine at the University of Miami by the Dean there, Dr. Pascal Goldschmidt. [Nemeroff Accepts Offer at U. Miami] In the process, Dr. Goldsmith contacted Dr. Thomas Insel, Director of the National Institute of Mental Health who said that Dr. Nemeroff could apply for NIMH Grants, and who allowed Dr. Nemeroff to continue serving on NIMH review Boards, even though he had been banned from participating in NIMH Grants by Emory.

Dr. Insel himself had moved to Emory from the NIMH in 1994 to accept the Directorship of Yerkes Primate Center at Emory, along with an appointment to Emory’s Psychiatry Department. In 1997, he left Yerkes to become a Director of a Center at Emory under the Department of Psychiatry. Dr. Nemeroff was Chairman of the Department during both appointments. Then in 2002, Dr. Insel became Director of the National Institute of Mental Health, and Dr. Nemeroff was reported to have been lobbying for that appointment.

The Chronicle of Higher Education recently published an article [As He Worked to Strengthen Ethics Rules, NIMH Director Aided a Leading Transgressor] that connected these dots and concluded that Insel’s support of Nemeroff for the Miami job was "payback" for Nemeroff’s earlier support of him.  That conclusion was supported by the email traffic between the two. Insel vigorously denied that charge, calling it "surreal" in a post on the Director’s blog on the NIMH Web Site:
More on Public Trust and Conflict of Interest
NIMH: Director’s Blog
by Thomas Insel
June 15, 2010

A recent story in the Chronicle of Higher Education implied that a quid pro quo relationship existed between me and Dr. Charles Nemeroff, formerly of Emory University. This story suggested incorrectly that Dr. Nemeroff helped me get a position at Emory in 1994, and that I assisted him in securing a position at the University of Miami after he was sanctioned for violations of financial conflict of interest rules at Emory. By switching from Emory to Miami, Dr. Nemeroff escaped a 2 year ban on applying for NIH grants, imposed by Emory. Senator Charles Grassley, a leading voice in the effort to reduce conflict of interest in biomedical research, has asked the Office of the Inspector General at HHS to look into this matter.

Having been one of the most outspoken proponents for developing tougher conflict of interest policies at NIH, the allegations that I would help anyone avoid penalties struck me as surreal. Here are the facts:
  1. Dr. Nemeroff was chairman of psychiatry at Emory School of Medicine in 1994 when I was recruited by the Vice President of Health Affairs to be Director of the Yerkes Primate Center, an appointment outside the School of Medicine. To my knowledge, Dr. Nemeroff had no significant impact on my selection.*
How could that be even possible? Yerkes is part of Emory and Dr. Insel was the first Physician [Psychiatrist] ever chosen to direct the institution. He was jointly appointed to the faculty of the Department of Psychiatry. It is inconceivable that Dr. Nemeroff had no significant impact on [his] selection. Inconceivable. But notice the asterisk. It wasn’t there when I first reported on Insel’s post [de-barred? not a bad idea…]. It just wasn’t there. But now it is there, probably added on June 23rd. It refers to this [also new] footnote:

* I acknowledge that this description may be viewed as misleading. In fact, Dr. Nemeroff served on the search committee at Emory, and my recruitment as Yerkes Director included an academic appointment in the Department of Psychiatry and Behavioral Science, then chaired by Dr. Nemeroff, in the Emory University School of Medicine, as well as an academic appointment in the Department of Psychology in the Emory University College of Arts and Sciences. Although my understanding is that Dr. Nemeroff did not play a supportive role in my hiring, I have no way of actually knowing all the facts.
Again, it is inconceivable that Dr. Insel did not know that Dr. Nemeroff was on his Search Committee at the time he first made this post. When you apply for such a job, you meet the members of the Search Committee. How could Dr. Insel truthfully say that "Dr. Nemeroff had no significant impact on my selection?" In fact, he couldn’t say that. So it’s inconceivable that his original post is truthful. We have "To my knowledge, Dr. Nemeroff had no significant impact on my selection" changing over in eight days to "Although my understanding is that Dr. Nemeroff did not play a supportive role in my hiring, I have no way of actually knowing all the facts" [and where might that "understanding" have come from?]. What changed in those eight days? What new information accounts for that footnote? The answer is that nothing changed except that probably someone else found out who was on the Search Committee and confronted him.
Plausible deniability actually is a legal concept. It refers to lack of evidence proving an allegation. Standards of proof vary in civil and criminal cases. In civil cases, the standard of proof is "more likely so than not" whereas in a criminal matter, the standard is "beyond a reasonable doubt" If your opponent lacks incontrovertible proof (evidence) of their allegation, you can "plausibly deny" the allegation even though it may be true.
Because I’ve been so noisy about this issue, and because I’ve been on the Emory faculty, I’ve been contacted asking if I might know of any information that might prove that Nemeroff helped Insel get the job at Yerkes. Well, I’m no insider. All I know is what I read in the increasingly public news. But I do know this: Plausible Deniability is neither a medical nor a scientific concept. In the Law, the focus is on protecting the rights of all parties concerned, so there is a high standard to convict. In medicine and science, the standards are different. The rights belong to the patients – there’s no equality. Simply the possibility of a Conflict of Interest is proof enough – in scientific research, in treatment decisions, in malpractice suits, in prescribing, just about anywhere. It is incumbent on the scientist and the physician to recognize a Conflict of Interest and pass the decision on to someone whose judgment is not compromised. In his original post, Dr. Insel writes:
While my response to Dean Goldschmidt was simply to describe the facts, in retrospect it would have been better to refer the Dean’s specific question about Dr. Nemeroff’s grant eligibility to someone from the NIH Office of Extramural Research, which coordinated the investigation of Emory University. But let’s be clear – my intent in this conversation was to explain a federal policy, not to exploit a policy that would help any investigator avoid penalties.

I realize that my tenure at Emory and a previous association with Dr. Nemeroff will, for some, be “guilt by association.” To avoid such allegations, I recused myself from all matters involving Dr. Nemeroff during the conflict of interest investigation at NIH. While I have had no contact with Dr. Nemeroff for many months, to avoid any possibility of a perception of either positive or negative bias, I will recuse myself from future applications or NIH matters involving Dr. Nemeroff. Note however, that I must comply with the current policy which permits someone to apply for NIH funding unless they have been de-barred.
"… in retrospect it would have been better" is wrong on two counts. It was Insel’s job to know about the conflict at the time. And "better" is not a synonym for "right". Specifically, in a climate where Insel is involved in writing new Conflict of Interest standards for the NIMH, in part because of Dr. Nemeroff’s misdeeds, his assertion "it would have been better" is ludicrous – as is "this description may be viewed as misleading." His original statement is misleading. And as for "I recused myself from all matters involving Dr. Nemeroff during the conflict of interest investigation at NIH… I will recuse myself from future applications or NIH matters involving Dr. Nemeroff." He’s kind of late coming to the table. Here’s an appropriate response to Dr. Goldschmidt in the first place:
    Dr. Goldschmidt: Charlie Nemeroff has shown interest for a job at the Miller School of Medicine. He mentioned that you may be willing to provide me with a confidential opinion. If indeed you do, I would call you whenever convenient.
    Dr. Insel: Your request puts me in something of a bind. As you know, Dr. Nemeroff has been a friend, a colleague, and former boss. However, because of my current position at the NIMH and the difficulties Charlie had with Emory and the NIMH, any comments I might make could be seen as reflecting an NIMH policy or opinion. For that reason, I have recused myself from all opinions or decisions involving Charlie inside of the NIMH. I’m afraid I must do the same with your request. Right now, I’m working on the new standards for Conflict of Interest for the NIMH, and I need to practice what I preach.
    February 4, 2011 | 4:46 PM

    […] NIMH Director Tom Insel isn’t exactly free from their taint himself. Consider his recent walk down the road with Charlie Nemeroff, head cheer-leader extraordinaire. Insel, himself, is also on the […]

    July 21, 2011 | 6:48 PM

    […] on his official weblog undated, it is mealy mouthed and it was widely criticized – here and here, for instance – as further evidence of Insel’s […]

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