More evidence that the NIH has no interest in curbing real COI
June 8, 2010
At all.
ScienceInsider overviewed a dismal story being reported by The Chronicle of Higher Education. It involves a tale I’ve discussed before with a new twist. ScienceInsider:
In 2008, a Senate investigation found that Nemeroff failed to report at least $1.2 million of more than $2.4 million that he had received for consulting for drug companies. NIH suspended one of Nemeroff’s grants, and in December 2008, Emory announced that it would not allow Nemeroff to apply for NIH grants for 2 years.
As I was just saying, this is the scope of the real problem. Changing the reporting rules from $10K per year to $5K per year does absolutely nothing about a guy who fails to report some or all of his outside activity.
Still, a 2 year suspension sounds like something, doesn’t it?
Nemeroff then applied for a job at the University of Miami’s medical school. According to e-mails that The Chronicle obtained, the school’s dean, Pascal Goldschimidt, e-mailed Insel in July 2009 to ask for a “confidential opinion” regarding Nemeroff. Insel replied that he could not provide a written recommendation but could talk to Goldschmidt informally by phone, which he apparently did, according to the e-mails. (Goldschimdt told The Chronicle he wanted to be sure Nemeroff could receive NIH grants and that Insel assured him “that Charlie was absolutely in fine standing.”) At the time, Insel co-chaired a new NIH committee to revise federal COI regulations; NIH proposed changes in those rules last month.
Or not. Sigh.
The Chronicle notes that Insel has been a stanch supporter of Nemeroff:
The administrator, Thomas R. Insel, director of the National Institute of Mental Health, also encouraged the researcher, Charles B. Nemeroff, to apply for new NIH grants, even though Emory had agreed on its own to restrict Dr. Nemeroff from NIH grant eligibility for two years. The NIH also allowed Dr. Nemeroff uninterrupted eligibility to serve on NIH advisory panels that help decide who receives NIH grant money.
Dr. Insel “confirmed to me that Charlie was absolutely in fine standing” with the NIH, Pascal J. Goldschmidt, dean of the University of Miami’s medical school, said of a July 2009 phone call he made to Dr. Insel just before hiring Dr. Nemeroff.
Why such strong support for a guy who has been investigated by Congressional committee, found to have violated rules by under-reporting and is a multi-time loser on the COI / disclosure / scientific ethics front by now?
Chronicle:
Dr. Nemeroff began offering help to the now-director of the NIMH in 1994, when Dr. Insel was facing the nonrenewal of his research job at the NIH, Mr. Carroll said, bringing him to Emory to serve as a professor of psychiatry and director of the Yerkes Regional Primate Research Center. Dr. Nemeroff also led a lobbying effort that helped ensure Dr. Insel’s appointment in 2002 as NIMH director, Mr. Carroll said.
The ScienceInsider bit Chronicle* then goes on to quote NIH spokesdude John Burklow with some of the usual weasel wording about how NIH rules don’t prevent Insel from giving a recommendation, blah, blah, blah.
It’s about optics, NIH. This doesn’t look good. The goal here is not to have some kind of face saving wink-wink-nudge-nudge that then let’s ne’erdo-wells get back to their same old work.
You don’t do this in cases of scientific fraud, right? I mean why can’t these poor chaps who get busted for faking data have a sentence that only applies at their current institution? Why can’t they have Directors of an NIH Institute land them a new job and go right back to advising the NIH in formal capacity and being awarded new grants?
F+ to Insel and F- to the NIH for allowing this to happen.
Updated: You can’t make this stuff up.
__
*ScienceInsider was just quoting from the Chronicle article.
N.b.: My usual disclaimer applies. I may have in the past have held, currently hold or be actively seeking research support from the NIMH. Cleaning house on this kind of stuff is therefore of actual or potential direct interest to my research program and career. I encourage you to read my comments with that in mind.
DrugMonkey 
June 8, 2010 at 1:07 pm
I respectfully disagree — I think this was a poorly reported article designed to create a specific conspiratorial impression in the reader.
In reality, Nemeroff has not been officially sanctioned by ORI and is officially eligible for grants, whether we like it or not. Thus, it would have been inappropriate for Insel to unilaterally announce a sanction that had not been applied through due process.
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June 8, 2010 at 2:48 pm
Neuro-conservative, I’m going to caveat my next few sentences by saying that I absolutely agree with everything you say.
I’ll also provide another caveat: I know Nemeroff and have worked with him in a consultant capacity. He is incredibly smart and an outstanding psych with a really honest approach to patient care. If I could have him as my doctor, I would.
But, let’s face some ugly truths: he messed up, and he messed up big time. Worse, he did so in such a way as to cast a shadow over his entire profession. As Drugmonkey says, it’s about how it all looks to the public eye. Let me ask you this: what do you think the response from all sides will be if Nemeroff gets another NIMH grant funded? The smartest thing for him to do for the next few years is to keep his head down, as no-one hoping to keep any integrity wants to be associated with him.
It is a shame really, as I am sure he still has smart ideas to contribute to psychiatry; whether any self-respecting forum will publish those now is up in the air.
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June 8, 2010 at 3:50 pm
And since “ Nemeroff has not been officially sanctioned by ORI and is officially eligible for grants, whether we like it or not”, here we have the Director of the NIMH recommending Nemeroff for a leadership position in a telephone call because “ as for NIH rules he could not provide a written recommendation”.
No one expects Dr Insel to “unilaterally announce a sanction that had not been applied through due process”, whatever due process might mean in this case. But most people would expect an NIH leader to exercise his best judgment when asked for a confidential opinion on an NIMH grantee whose behavior had purportedly violated some professional rules.
IMO, Dr Insel should have advised Dr Nemeroff to temporarily recuse himself from seeking a position involving NIH funding. Given his longstanding relationship with Dr Nemeroff, the NIMH Director was in a unique position to help Dr Nemeroff to rehabilitate himself. This is what leadership is also about: helping leaders to face and take responsibility for their errors.
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June 8, 2010 at 4:03 pm
N-c, yes, I recognize that there are some gaps here and that reporting requirement violations are by no means treated like scientific fraud. Agree, it would be very difficult for the NIH to ban Nemeroff formally (informally, we all know Program has a boatload of latitude, yes, even to pass on grants which get top scores).
But I’d prefer to see a little more backing of the spirit of the law even if their hands are tied in some domains by the letter.
As in “Yeah, if he manages to land a job somewhere, we cannot enforce any kind of formal ban. However, we do feel this behavior is a BadThing and we will be seeking to strengthen our policies so that egregious COI such as this can in the future be treated with penalties similar to fraud”. And “We will not be seeking his services in any advisory capacities, as is our perogative”.
WRT to Insel, I just can’t believe these folks can’t understand how unbelievably bad it looks to defend these cases of cartoonish excess (remember, this is a longstanding trend with Nemeroff, the reporting violation followed a case of nondisclosure in a review article pumping products in which he had significant interest). Especially when they are making a bunch of noise over the $5K reporting threshold. It just doesn’t pass the smell test.
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June 8, 2010 at 4:12 pm
It’s also worth noting that, even under the proposed new rules, they still wouldn’t have identified Nemeroff, who by his own admission, didn’t declare over 90%+ of his income. The only difference now is that, when cases like this are caught, because the institution is now in the role of determining where there is a conflict, it places the onus of responsibility squarely on the shoulders of the investigator. You can no longer hold up your hands like Nemeroff did and say “I didn’t realize it”.
It would be nice for the NIH to issue guidelines on how to manage conflict though. So far they are leaving it up to the individual institutions.
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June 8, 2010 at 5:11 pm
The psycho-pharmacological takeover of Psychiatry. (Drug Money takeover seems fitting)
These pseudo clinical trials (small and inconclusive by design) with their hockey stick statistics and pre-ordained outcomes, as well as the MD speaking tours shilling drug products for personal gain and feeding university coffers with taxpayers’ funded grant money, must stop. It is immoral. These doctors convince us we are sick and need drugs, and if that does not work our children are even sicker and need drugs. They sometimes even convince themselves that the majority of us need psychopharmacological agents Why? If we are sick then they can be are saviors. Now that is sick.. there must be a Physch name for this relationship?
Risperdal, Zyprexa, Geodon, Haldol, Zoloft, Anaphranil, Luvox, Prozac, Ativan, Valium, Tegretol, Lamictal,Topamax, Depakote and Dr. Nemeroff’s favorite paroxetine [paxil]
Some 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age. When does it stop? Every few years there is a new drug that needs a new disorder bipolar, ADD. It seems very unlikely that these drugs do anything for mild depression, particularly for long term treatment.
From Emory Wheel-
Focusing on documents from January 2000 to January 2006 provided by GSK, the largest single payer and “most forthcoming with information,” Emory General Counsel Kent Alexander’s office led the fact-finding phase of the in-house investigation and concluded that NIH policies [and federal policy] had been violated, University President James W. Wagner said. The internal investigation determined $800,000 in unreported outside income.
Now clearly, this investigation should have been turned over to the ORI.
Help needed. Someone please fill comments about in the vagus nerve stimulation device? story of Dr. Nemeroff and Cyberonics Mechanism of Action Advisory Board and Journal of Neuropsychopharmacology.
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June 8, 2010 at 5:16 pm
The real NIH COI elephant in the room is the way NIH grantees decide the priority scores of NIH grant applications. It’s just hard to get excited over the chump change of a couple million in “consulting fees” from industry next to that.
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June 11, 2010 at 1:02 pm
As a follow-up to this, it seems that Francis Collins has come out to say how this case highlights the gaps in NIH conflict rulings, and how the NIH needs to learn from this, particularly in making sanctions apply to the investigator, not just the institution
[Ed- link ]
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June 15, 2010 at 6:58 am
The Director of the Orchestra will testify on June 15
On June 11, the Chairman and Ranking Member of Energy and Commerce Committee released a memorandum on the hearing to be held on June 15, “NIH in the 21st century: The Director’s Perspective”. Francis Collins is so far the only witness expected to testify. I guess that this is the consequence of recently enacted legislation: “The NIH Reform Act of 2006 focused on strengthening the Director’s role and his/her ability to set an overall direction for NIH and foster increased research collaboration among institutes and centers. The Act also sought to ensure that NIH’s research addresses current scientific opportunities and public health burden, and to improve evaluation efforts of the agency’s research portfolio. Several provisions within the Act were informed by recommendations of a 2003 Institute of Medicine report, “Enhancing Vitality of the National Institute of Health: Organizational Change to Meet New Challenges”.
Please, see htpp://energycommerce.house.gov/documents/20100612/Briefing.Memo.he.06.15.2010.pdf).
When I read the announcement I could not help but remember some months ago when public voices (and some within the scientific community) were concerned about Francis Collins not being the most appropriate leader for NIH because of his religious views:
“OMG, Stem cell research will be dead with him…….
“ OMG, he is going to give full preference to research on “ Genetic basis and genomic approaches for adoration of the Trinity and the Fountains of Life”.
“OMG, he is going to give 100% effort credit to investigators praying God 45 minutes before initiating every experiment. What about those of us who were never trained to pray?….”
So far it appears that all those concerns were truly delusional thoughts!!!. And the latest reality check for the NIH (seen in the press) appears to indicate some darkness in existing “scientific” opportunities that might be negatively impacting a) public health, b) public credibility in NIH and c) NIH vitality as a government agency engaging multiple national and international research efforts to the public benefit.
If I recall what happened on August 17 2009, Francis Collins used the “orchestra” metaphor when speaking about NIH and its mission. I liked the metaphor a lot and strongly believe that the orchestra metaphor is a truly workable one. The conductor needs determination to address and overcome “obscure sounds” but he also needs support from NIH itself, the scientific community and the public.
Dr Collins, you have my support and I wish you the best
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April 16, 2012 at 4:44 pm
[…] on keeping on as if nothing happened. Some patsy University will happen along to hire the dude if they think it is in their interest to do […]
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May 29, 2012 at 10:35 am
[…] on: Nemeroff's third strike Inselgate Inselgate […]
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