• November 28, 2014

As He Worked to Strengthen Ethics Rules, NIMH Director Aided a Leading Transgressor

While Revising Ethics Rules, NIMH Director Aided a Leading Violator 1

Dennis Cook, AP Images

Thomas R. Insel, director of the National Institute of Mental Health, shown here testifying before a House subcommittee, led an effort to strengthen ethics rules for medical researchers yet helped a doctor known for not disclosing his financial ties to drug companies get a new position.

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close While Revising Ethics Rules, NIMH Director Aided a Leading Violator 1

Dennis Cook, AP Images

Thomas R. Insel, director of the National Institute of Mental Health, shown here testifying before a House subcommittee, led an effort to strengthen ethics rules for medical researchers yet helped a doctor known for not disclosing his financial ties to drug companies get a new position.

A yearlong effort by the National Institutes of Health to toughen its policies against financial conflicts of interest was led by an administrator who quietly helped one of the most prominent transgressors get hired by the University of Miami after a decade of undisclosed corporate payments led to his departure from Emory University, a Chronicle investigation has found.

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.

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.

"It leaves everybody scratching their heads as to what Insel's posture and NIH's posture about ethics is," said Bernard J. Carroll, who served as chairman of the psychiatry department at Duke University from 1983 to 1990, while Dr. Nemeroff was a professor there.

Dr. Insel has declined months of requests from The Chronicle for an interview to discuss the matter, including his relationship with Dr. Nemeroff. The NIH's director, Francis S. Collins, was not available for comment, his spokesman said late last week. Dr. Nemeroff also declined to be interviewed, a University of Miami spokeswoman said.

Corporate Payments to Scientists

Dr. Nemeroff is one of several high-profile doctors found to have given speeches or written articles in medical journals extolling drugs or products made by companies that had paid them money or stock benefits that they did not report to their universities.

The NIH, with a $31-billion annual budget that makes it the largest provider of federal research money to universities, relies primarily on the institutions to guard against financial conflicts involving industry. Even the proposed new NIH regulations, outlined on May 20 after a yearlong review led by Dr. Insel, don't change that fundamental approach.

Instead, the new NIH rules would require researchers only to give their universities more details of such outside payments, and require the universities to publicize both the money and their plans for mitigating its influence on science. The proposal contains no new penalties for researchers or universities that fail to comply. Past audits by the inspector general of the U.S. Department of Health and Human Services have criticized both universities and the NIH as insufficiently attentive to the problem. The latest inspector-general report, issued in November, recommended many of the changes ultimately outlined last month by the NIH. But the inspector general also called for more vigorous overall oversight by the NIH, and watchdog groups have suggested that the actual amount of energy spent by the NIH on enforcing its new rules will represent the critical unknown element in the regulations' ultimate success.

In the case of Dr. Nemeroff, a pattern of accepting undisclosed corporate payments goes back at least a decade. In 2003, the journal Nature toughened its policies for author disclosures after Dr. Nemeroff used an article in Nature Neuroscience to praise treatments for depression in which he had an unreported financial interest. In 2004, Emory issued a report citing him for multiple "serious" violations of its conflict-of-interest policies for protecting patients.

He quit as editor of the journal Neuropsychopharmacology in 2006 after he was reported to have endorsed an implantable device for treating depression without disclosing payments from its manufacturer. And he finally left Emory last year, after U.S. Senate investigators found he received $2.8-million from GlaxoSmithKline and other pharmaceutical companies between 2000 and 2007 and failed to disclose at least $1.2-million of it.

Dr. Nemeroff has largely avoided NIH restrictions for such actions, though the agency did freeze one grant to Emory in 2008 after Senate investigators released their findings. Emory responded to the Senate findings by announcing in December 2008 that it would not allow Dr. Nemeroff to apply for NIH grants for two years, but the university's promise did not apply to any future employer.

A year later, Dr. Nemeroff assumed his new position, professor and chairman of the department of psychiatry and behavioral sciences, at the University of Miami. His new supervisor, Dr. Goldschmidt, said he was pleased to hear from Dr. Insel that Dr. Nemeroff not only could begin applying for NIH grants as soon as he arrived in Coral Gables, but that he could also continue to serve on the NIH's expert panels that help decide on which grant applications win federal financing.

After Dr. Nemeroff wrote to Dr. Insel in October 2009 announcing that he had taken the University of Miami job and had already begun discussions with NIH officials about new grant opportunities, Dr. Insel wrote back saying: "Congrats on the new position! Should be a new beginning. Tom"

It was the latest benefit for both sides to a relationship that Dr. Nemeroff had cultivated for at least 16 years, said Mr. Carroll, now scientific director of the Pacific Behavioral Research Foundation, a nonprofit mental-health research foundation in California.

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.

Mr. Carroll, who supervised Dr. Nemeroff for six years at Duke, describes the career assistance for Dr. Insel as part of a strategy in which Dr. Nemeroff would "put people in debt to him, and then call in the chips later."

Vetting a Candidate

The e-mail correspondence, obtained by The Chronicle from the NIH in response to a request under the Freedom of Information Act, showed that Dr. Goldschmidt wrote to Dr. Insel in July 2009 asking for "a confidential opinion" regarding Dr. Nemeroff.

Dr. Goldschmidt said in an interview that he already had enough recommendations by that time to make him feel comfortable about hiring Dr. Nemeroff, and only wanted to hear Dr. Insel's direct assurance of his NIH eligibility. "Recruiting Charlie, I was quite concerned with his standing, with the NIH specifically, because I was not going to recruit somebody who could not apply for NIH grants," Dr. Goldschmidt said.

But Dr. Insel, writing back five minutes later, saw an even wider opportunity to help, offering to provide Dr. Goldschmidt with his own words of recommendation. "I cannot provide a written, formal recommendation by NIH rules," Dr. Insel told Dr. Goldschmidt. "However, I can discuss informally by phone."  Calendar records show they spoke by phone 10 days later, on July 27. Dr. Nemeroff wrote to Dr. Insel later that day, making plans to meet the following morning for breakfast before they attended a conference in Philadelphia and thanking him for the help with Dr. Goldschmidt, saying, "I appreciate your efforts."

An NIH spokesman, John T. Burklow, answering written questions about the matter, confirmed Dr. Nemeroff's full eligibility for agency activities and said he will begin serving this coming week on two scientific panels that review NIH grant applications, his first such assignments in two years. The NIH must "treat everyone equally unless they have been 'debarred' from funding," Mr. Burklow said.

Mr. Burklow's response did not deal with other questions posed by The Chronicle, including a request for details of how Dr. Insel came to be named co-chairman of the NIH panel that wrote the new rules on financial conflicts of interest, and whether NIH policies should prohibit or restrict participation by researchers with a track record such as that of Dr. Nemeroff.

Dr. Goldschmidt said he remains impressed by Dr. Nemeroff's professional reputation and gained further confidence from Emory's own investigation concluding that his mistakes were limited to incomplete financial disclosures.

"Charlie committed to me that he would never make these mistakes again, and I am scrutinizing his activities to make sure that that remains the case," he said. "As far as I can tell, Charlie does not engage in that type of behavior anymore, and I can tell you that if he was, I would know it."

And the University of Miami, while trusting Emory's conclusion that the corporate money didn't affect Dr. Nemeroff's scientific assessments, doesn't feel obliged to accept Emory's judgment about the need for a two-year ban on NIH grant activities, Dr. Goldschmidt said. That ban, he said, "was an immediate reaction to the political pressure that the university was under."

Relationships between academic researchers and industry are essential to medical progress, and must be maintained with proper safeguards, Dr. Goldschmidt said. The University of Miami intends to be a leader in that area, he said, and was cited just two months ago by Daniel R. Levinson, inspector general of the Department of Health and Human Services, as a leader in creating an online database of its doctors' relationships with outside companies.

Mr. Carroll remains unconvinced that the NIH and the University of Miami are doing enough to ensure those safeguards. He says that the behavior of Dr. Nemeroff, with the acceptance of government officials such as Dr. Insel, has the potential to bring real harm to thousands of patients. He cites a series of examples, such as the drugs Abilify by Bristol-Myers Squibb and Risperdal by Janssen, in which he believes Dr. Nemeroff has repeatedly exaggerated the benefits while downplaying or failing to mention serious side effects. Common side effects of Abilify, Mr. Carroll said, include a condition known as tardive dyskinesia, which involves abnormal, involuntary movements of the face, tongue, or other body parts.

Dr. Goldschmidt said he can't evaluate such assertions on the medical merits, but he says that he worries when such debates "become politicized" and that he trusts the confidence that Emory placed in Dr. Nemeroff.

The NIH's regulatory review process, led by Dr. Insel and Sally J. Rockey, the NIH's acting deputy director for extramural research, proposed leaving universities in charge of guarding against financial conflicts of interest involving their researchers. But when the new regulations are implemented in a few months, they will give both the NIH and the public more confidence in the conflict-of-interest protections, by requiring universities to give the agency details of their mitigation plans in cases in which a researcher reports a payment from a company, agency officials said. And Congress, as part of the health-care overhaul bill passed in March, requires companies to publicly report their payments to doctors.

The problem all along, Ms. Rockey wrote to Dr. Insel in one e-mail last November, has been that researchers "don't disclose, and the institutions don't know about it."

Comments

1. busyslinky - June 07, 2010 at 05:49 am

Solid reporting. Lot's of 'good ole boying' going on with millions in grant money involved. Despicable.

Interesting observation. CHE is using Dr. in some cases and Mr. in other cases. An MD = Dr. and a Ph.D. = Mr?

2. roro1618 - June 07, 2010 at 05:58 am

Criminals helping criminals...

3. 11159995 - June 07, 2010 at 06:29 am

If the claims as stated here are correct, neither Insel nor Nemeroff should be holding the positions they do. How many chances should a repeat violater like Nemeroff get? And the behavior of Insel is despicable for its sheer hypocrisy.

4. trendisnotdestiny - June 07, 2010 at 07:15 am

Wow! Could not have a better argument for the practical use of the humanities, feminism and critical theory here... Foucault and Gramsci as well






5. chedie - June 07, 2010 at 07:34 am

How does someone as corrupt as Insel end up in charge of overhauling ethics anywhere? No wonder people have no trust in government or its agencies.

6. honore - June 07, 2010 at 07:59 am

Ethics? Professionalism? Honesty? Fairplay?
Oh yes, the doctors are all in and so is the fix.
Do we really have to ask why H/E is more and more a sickening pigsty of greedy piglets.
Fire them all! Then ban the "research" money with all of its attendant pressures to steer the "research" in a direction that benefits the $ources.
Just a pathetic joke, but no one is laughing except these culprits at the bank drive-up window.

7. fullprof99 - June 07, 2010 at 08:20 am

MD = Doctor, PhD = Mr. in Chronicle's style.

8. commsadmin - June 07, 2010 at 12:43 pm

Pretty solid reporting--but as for the relationship between the two, it isn't that hard to find out that they worked together at Emory before Insel left for NIH.

Fullprof99--you are correct on MD and PhD = dr. and mr., which is dictated by all the major journalism style guides. Dr. used for medical professionals only.

9. amyjane - June 07, 2010 at 02:09 pm

I applaud Insel's support of Dr. Nemeroff. In my opinion neither of them has done anything wrong. The fault for the Nemeroff fiasco lies with Emory and their poor accounting practices, not with anything Nemeroff did intentionally. If Emory had provided Dr. Nemeroff with the proper forms and instructions for disclosing his conflicts of interest, he would have done so. Emory is still struggling with providing a proper infrastructure for real medical research. Let's not punish these outstanding scientists any longer for the poor administrative practices of their home institution.

10. tcli5026 - June 07, 2010 at 02:32 pm

I never noticed the Chronicle's usage of "Dr." only for medical doctors and "Mr." for doctors of philosophy. I was curious about the implication of commsadmin's comment, that all major journalism style guides--and, therefore, most major newspapers--follow this usage. I did a quick check of the New York Times and Washington Post. In fact, I found that both used "Dr." for individuals who do not have medical degrees.

It's a bit ironic that the Chronicle of Higher Education would be a stickler for this particular usage rule, while the two leading newspapers in the US have adopted a more flexible usage.

11. tcli5026 - June 07, 2010 at 02:34 pm

amyjame: Curious. Do you have anything to support your argument that the fault lies with Emory? If so, can you point us in the right direction?

12. gerrymander - June 07, 2010 at 06:42 pm

I would be interested in seeing amyjane provide evidence to support this contention:
"The fault for the Nemeroff fiasco lies with Emory and their poor accounting practices, not with anything Nemeroff did intentionally. If Emory had provided Dr. Nemeroff with the proper forms and instructions for disclosing his conflicts of interest, he would have done so. "

Nemeroff signed a form which said that he had accepted $10,000 or less from sources outside of Emory. As Senator Grassle confirmed with the drug company involved, Dr. Nemeroff had in fact accepted more than $96,000 from the drug company.

Emory was lax in enforcing its conflict of interest policy. That case can be made, but Dr. Nemeroff simply lied to Emory. That he was not fired for his malfeasance shows how powerfully connected he is. A faculty member less well connected would never have landed as chair of a different department of Psychiatry. That Miami was willing to look the other way speaks volumes about their priorities.

Emory is fortunate that Dr. Nemeroff left.

13. wepstein - June 07, 2010 at 08:38 pm

The bigger problem and the one that needs immediate investigation is the allegations or possibility that Dr. Nemeroff's research was compromised by his lucrative ties to the drug companies. Disclosure is serious but the distortion of findings is grave. In any event, NIMH has rarely distinguished itself for funding disinterested research or even first rate research. Most of its money is wasted on porous studies that simply flatter the field's revailing clinical preferences.

14. princeton67 - June 07, 2010 at 08:56 pm

Jeez, someone would think Nemeroff was a coach or an athlete.
"Not report" income - to the college or to the IRS?

15. davi2665 - June 08, 2010 at 08:32 am

The behavior of Tom Insel is inexcusable and should be grounds for immediate dismissal. Charles Nemeroff is nothing but a scam artist and an unethical so-called scientist- even more disgusting because of the risk he placed patients in for taking some of the very dangerous drugs for which he was a shill. This is precisely the kind of corruption that needs to be removed from the NIH system and from academia. Withholding information from NIH and from Emory about payments from drug companies while purporting to do objective research on their drugs is nothing more than a deliberate misrepresentation and fraud. Nemeroff should be removed from academia and from NIH grants, study sections, etc., not rewarded with a new position at Miami. His appointment there speaks volumes about the ethical standards at U of Miami. The fact that Emory did not immediately dismiss Nemeroff also speaks volumes about the corrupt influences of money in the academic grant games. The good ol' boy network is alive and well, and Nemeroff has, so far, gotten away with his posturing as the "boss of bosses." How nauseating.

16. drsnuggles - June 08, 2010 at 10:40 am

This a culture. Don't expect these guys to change because they don't really think they're doing something wrong.

17. kalisto2010 - June 08, 2010 at 11:59 am


If this is a culture, we'd better do something to fix it. I would like to believe that Dr Insel has a genuine interest for the patients, for Psychiatry and for NIMH. After the revelations on his questionable support of Dr Nemeroff, the best thing he could do is to resign from his position at the NIMH.

18. lkaiser - June 08, 2010 at 04:44 pm

Charlie Nemeroff is a distinguished investigator who has had an incredibly productive career. That is fact. He certainly is not alone in not fully disclosing some relationships that in retrospect might be interpreted as conflicted but the issues are complex. He has acknowledged the conflicts but what can't be taken from him is his tremendous record of accomplishments as a researcher and department chair. Dr. Carroll seemingly has nothing better to do than trash Dr. Nemeroff and because he has made a career of this he essentially has neutralized himself. His criticism of Dr. Nemeroff no longer has meaning since it is nothing but a ridiculous personal vendetta. Dr. Carroll: get a life. Go bang your head against a wall to take out some of your agression against Dr. Nemeroff. What have you done lately? Thank goodness Pascal Goldschmidt had the insight and chutzpah to hire Nemeroff who deserves to be in a place where he can continue to make significant contributions.

19. speakurmind - June 08, 2010 at 10:54 pm

From reading the article newspapers should revise their policies. First, it is insulting that PhDs are referred to as Mr while they certainly have earned that privilege and second, given their behavior, it should become obvious that Mr. Insel and Mr. Nemeroff should take example from Dr. Carroll and see if he has any conflicts of interest to declare.

20. goxewu - June 09, 2010 at 01:42 pm

I don't have a dog in this fight, and it's waaaay out of my field, but #18 is one of those totally irrelevant character puffs that reads like it was written by Dr. Nemeroff's uncle or his attorney. To wit:

* Dr. Nemeroff's distinguished-ness as an investigator and the productivity of his career are irrelevant to his transgressions.

* That Dr. Nemeroff wasn't alone in transgressing is essentially the, "Well, everybody does it" excuse.

* Dr. Nemeroff has, admits #18, "acknowledged the conflicts." This is a separate issue from somebody supposedly trying to "take from him" his record as a researcher and a chair.

* Dr. Carroll's "seemingly ha[ving] nothing better to do than to trash Dr. Nemeroff" is the old "kill the messenger" defense.

* No evidence at all is offered concerning Dr. Carroll's alleged "ridiculous personal vendetta."

* "What have you [Dr. Carroll, that is] done lately?" is totally irrelevant.

* Instead of having "insight and chutzpah" (well, maybe chutzpah), Pascal Goldschmidt seems to have been hoodwinked by Dr. Insel, who's in the docket along with Dr. Nemeroff.

* Dr. Nemeroff's being "in a place where he can continue to make significant contributions" seems--on the basis of his own admissions and on Dr. Insel's apparent hoodwinking Pascal Goldschmidt--to carry with it a concommitant risk of his indulging in further conflicts-of-interest.

Again, I don't know the parties, and read this piece just because I'm interested in the politics of science. But lkaiser should know that most readers of his/her comment would probably think that it detracts from, rather than adds to, Dr. Nemeroff's reputation.

21. optimysticynic - June 09, 2010 at 04:05 pm

Thank you, goxewu, for the critical analysis of the "good man" defense offered by lkaiser. Having personal knowledge of both Nemeroff and another bigwig NIMH fund-getter (who must remain nameless or my anonymity is dead) it is clear that the pattern is simply to move to another university when the current one blows the whistle. The other bigwig had to move twice to get sufficient distance from his misdeeds (which were also financial conflicts of interest, but also keeping patients in protocols who were demonstrating life-threatening side effects). My current institution recently went through a similar debacle with someone who was also hired with a known bad rep. The kicker is: NOTHING TRUMPS EXTRAMURAL MONEY. If you promise to bring it in, they don't care who you are, what's happened in the past or how big a fraud/liar you are; it's worth it to get the grant monies. Simple quid pro quo. Ethics? There are none in psychiatric drug research. And, it should also be pointed out, this is hardly ground-breaking research. For the most part, it is atheoretical, outcome-based hack work--nothing scholarly in the least.

22. qwert11 - June 10, 2010 at 09:14 pm

Let's not forget Insel was also involved in the case of the NIMH Alzheimer's researcher who was convicted in federal court of criminal COI. He was signing off on retention bonuses for the guy (Sunderland) despite his under-the-table dealings, and also discouraged investigation into his turn-over of valuable biological samples to Pfizer.

23. qwert11 - June 11, 2010 at 10:25 pm

I'm relieved to hear "Charlie committed to (Dr. Insel) that he would never make these mistakes again." Might Dr. Insel let us in on how such deep characterological flaws are remedied? Maybe he could bottle it, and fund Dr. Nemeroff to research/market it. ; )

24. 1boringoldman - June 14, 2010 at 09:40 am

It's tempting to join in the sarcasm of the other comments, but Nemeroff is a special case deserving serious consideration. Those of us in Atlanta and associated with Emory can attest to the fact that he is not just unethical, not just a self promoter, he is, in fact, a charlatans. I was never able to sit through the entirety of one of his presentations - they were too obviously sales jobs. While he talks, he "twiddles" his thumbs. I wondered if he did it just when he was lying, but since he did it all the time...

The comment above by lkaiser is what's wrong with academia today. "Thank goodness Pascal Goldschmidt had the insight and chutzpah to hire Nemeroff who deserves to be in a place where he can continue to make significant contributions." I suspect lkaiser is referringto "contributions" to a 401K Plan heavy in GSK and other Pharma stock. Either Pascal Goldschmidt doesn't have an Internet connection, or he is a member of Charlie's snake oil club himself, I suspect the latter.

There is an old saying that brought medicine out of the sea of cults in ancient greece, "Do no harm." People like Nemeroff seem determined to to put us back on priestess row with the other charlatans.

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