More than two years ago, the National Institutes of Health promised to crack down on the growing problem of university researchers’ taking money from companies whose products they study.
The promise hasn’t been kept.
While some changes may be drawing near, newly obtained records of a high-profile conflict of interest involving a top NIH official and a University of Miami researcher may only compound questions of whether the agency and its planned new rules will be tough enough.
The process of drafting the new rules has dragged on in part because the NIH official, Thomas R. Insel, director of the National Institute of Mental Health, was found last year to have been helping a former colleague, Charles B. Nemeroff, avoid a ban on NIH grant eligibility by getting a new job at the University of Miami.
Dr. Nemeroff had quit as chairman of Emory University’s psychiatry department in December 2008 after the university received complaints about his secretly receiving money from GlaxoSmithKline and other pharmaceutical companies while helping promote their products. But with the assistance of Dr. Insel, a former professor of psychiatry at Emory, Dr. Nemeroff became chairman of psychiatry and behavioral sciences at Miami less than a year later.
The NIH director, Francis S. Collins, halted the rule-making process in June 2010, after The Chronicle revealed Dr. Insel’s contact with Miami on behalf of Dr. Nemeroff. Dr. Collins said he wanted to take the time necessary to ensure that the new rules would make clear that any penalties or sanctions against a researcher would remain in effect if the researcher moved to another institution.
Dr. Insel, in a letter to Sen. Charles E. Grassley—a Republican of Iowa who has pressed for tougher rules on financial conflicts of interest in medical research—acknowledged his longstanding career ties to Dr. Nemeroff and agreed to recuse himself from all NIH matters involving him.
E-mail records obtained by The Chronicle, however, suggest it’s been an elusive promise. In one e-mail, from November 2008, Jane A. Steinberg, director of the Division of Extramural Activities at NIH, said Dr. Insel could not be involved in a decision on the future of an NIH grant involving Dr. Nemeroff, because of “Tom’s conflict with Nemeroff.”
In a January 2009 e-mail to Ms. Steinberg, after Dr. Nemeroff had stepped aside at Emory, Dr. Insel said he felt it was “time to revise recusal.”
A few months later, he helped Dr. Nemeroff get hired by Miami. In July 2010, after that assistance had become publicly known, Dr. Insel gave Senator Grassley the written promise to again recuse himself from matters involving Dr. Nemeroff.
The NIH, in a written response to The Chronicle’s questions about the on-and-off recusal status, said the first recusal had been issued “because Dr. Insel’s and Dr. Nemeroff’s prior relationship may have caused an appearance of conflict to someone else.” That recusal was no longer necessary, the NIH said, when Dr. Nemeroff left Emory.
New Rules Await Approval
It’s not clear, however, that the conflict didn’t move along with Dr. Nemeroff to Miami. According to e-mail records, he repeatedly contacted Dr. Insel for help with NIH grants, including attempts to renew and relocate his work at Emory.
In one message, from July 2009, Dr. Insel told Dr. Nemeroff that he wouldn’t try to override others at NIH who decided to let Emory keep control of a five-year, $4.9-million NIH project, involving GlaxoSmithKline, to develop drugs to treat depression and other mood disorders. “I know this is not what you want to hear,” he wrote to Dr. Nemeroff.
Yet the NIH did agree to extend the project at Emory for another five years and $10-million. The agency did so despite some experts’ concerns that the first five years’ results had fallen short of promised breakthroughs.
The NIH, in its response, said the study “has led to a number of important preclinical findings, and has also resulted in further pursuit of potential new treatment approaches.”
The NIH’s new conflict-of-interest rules, meanwhile, were finished in March and sent to the White House’s Office of Management and Budget for approval. Under the rules, the trigger for a researcher to report a potential conflict to his or her university would be lowered to $5,000 in payments, from the current level of $10,000.
Also, the university rather than the scientist would be responsible for judging whether the payment relates to his or her federally sponsored research, the university must tell the federal agency of its plan to handle the conflict, and the university must post details of the conflict on a public Web site.
At Miami, those decisions would be handled by the medical school’s dean, Pascal J. Goldschmidt, who hired Dr. Nemeroff after conferring with Dr. Insel. The dean subsequently said that he understood the concern over Dr. Nemeroff’s track record, and that he would be “scrutinizing his activities” to be sure he reports all future income from outside companies.
Dr. Goldschmidt was found last month to have underreported his income from service on the boards of two outside companies.
