1 Boring Old Man

It was touted as an COI [conflict of interest] problem, but it was more that. It was a case of a pharmaceutical company hiring an academic department to push their products. It appears that the company actually ghost-wrote some of the papers published under Dr. Nemeroff and other colleagues names. Further, they recommended use of a drug in pregnancy that seems to be associated with birth defects. It wasn’t just a slip-up, it looks like it was a scam to me.

As He Worked to Strengthen Ethics Rules, NIMH Director Aided a Leading Transgressor
The Chronicle of Higher Education
By Paul Basken
June 8, 2010

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…

"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."

At the NIH, conflicting stories of conflict of interest
Washington Post
by Al Kamen
06/09/2010

 … Insel, however, called the article a "little surreal." He didn’t have "any great relationship" with Nemeroff, he said in a telephone interview, and what Nemeroff "had done was so outrageous, he became the poster boy for conflict of interest."

"I didn’t recommend him" for the Florida job, Insel said, but only clarified to an official there that Nemeroff was not barred from applying for future NIH grants.

The problem, he said, was that after Nemeroff was "penalized" at one institution, he "jumps to another. I can see why Sen. Grassley is upset," he added. "I would be upset at that, [but] we can do nothing about the individual – the grants are given to the institution"…

As He Worked to Strengthen Ethics Rules, NIMH Director Aided a Leading Transgressor
The Chronicle of Higher Education
By Paul Basken
June 8, 2010

… 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"…

[1] Dr. Insel writes to Dr. Nemeroff that someone [else] at Emory was chosen Principle Investigator of a grant, I surmise it is one formerly under Dr. Nemeroff.
[2] The Dean at Miami, Dr. Goldschmidt, contacts Dr. Insel asking for a recommendation for Dr. Nemeroff who is applying for the Chair in Psychiatry.
[3] Dr. Insel declines a request for recommendation from Dr. Goldschmidt, but says he will talk informally over the phone.
[4] Dr. Goldschmidt agrees to call.

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."

[5] In an email to Dr. Helen Mayberg, Dr. Insel assures her that Charlie Nemeroff is going to get an offer from the University of Miami soon, making her life at Emory easier.
[6] She says she’s pulling for Charlie.
[7] Charlie tells Dr. Insel he got the job and is already talking to Linda Brady [at NIMH] about grants.
[8] Dr. Insel congratulates Charlie, telling him it’s a "new beginning"…

It just isn’t possible that Emory doesn’t know what Dr. Nemeroff was doing. They stated that they could find no evidence that Nemeroff’s affiliation with the Drug Companies had an influence on his scientific work. But they’re using a standard of proof by which we measure criminals in a court of law. Medical ethics hold us to a higher standard. The fact that he was selling people on drugs and treatments that he was profiting from while supposedly doing research on them is bad enough. But the drug companies were ghost-writing papers and reviewing results. The research was driven by the company’s marketing plan [pregnant women] and Nemeroff and colleagues were making recommendations that were ill-concieved – wrong [Paxil in pregnancy]. Emory took the safe path and avoided seeing the obvious truths in the Nemeroff story…

Likewise, it isn’t possible that Nemeroff didn’t know the rules about reporting. Emory had gone the extra distance and told him specifically what the rules were. So was he a paid shill for PHARMA? Of course he  was  is. As they sometimes say about certain folks, "You know he’s lying because his lips are moving."

It’s very clear that Dr. Insel’s denials in the Washington Post were not true – from his correspondence with Dr. Helen Mayberg, his emails with Charlie Nemeroff, and the reports of Dr. Pascal Goldschmidt. Dr Insel helped Charlie Nemeroff get the job and reassured Dr. Pascal Goldschmidt about Charlie’s NIMH connections. Insel’s denials were CYA in action.