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."