The National Institutes of Health has stopped a major $9.3-million, five-year study at Emory University because of concerns over payments made by drug companies to the former chief researcher on the project.
The university received funds for the first two years of the project, a study on depression, but the NIH froze the rest of the money for the study this summer, according to Ron Sauder, vice president for communications at Emory. The study ceased recruiting new patients in August, although it is continuing to provide treatment for 11 individuals, who had been enrolled before support was cut off.
The study was supposed to enroll 400 people to study different factors—such as genetic screening and brain scans—that could tell doctors how to identify the best treatment options for individual patients.
The NIH froze support for the study because of concerns about Charles B. Nemeroff, a professor of psychiatry and the project’s former principal investigator. Last month Sen. Charles E. Grassley of Iowa sent a letter to Emory’s president inquiring about Dr. Nemeroff’s earnings from drug companies like GlaxoSmithKline and whether they had been properly disclosed. Mr. Grassley is the top Republican on the U.S. Senate Committee on Finance, and has raised similar concerns about researchers at Harvard and Stanford Universities, and the Universities of Cincinnati and Texas (The Chronicle, August 1). .
According to the letter, pharmaceutical companies told committee investigators that Dr. Nemeroff had received nearly $2-million from them for speeches and consulting work between 2000 and 2007. During the same period, however, he failed to disclose most of those payments to his university, as is required by university and federal policies. In some cases, Dr. Nemeroff received money from companies while conducting research on their products.
Broken System
Dr. Nemeroff voluntarily stepped down as chairman of the psychiatry department, pending an investigation, according to the university. He has been replaced as the principal investigator on the depression study by Helen S. Mayberg, a professor of psychiatry.
Mr. Sauder, the Emory official, said that Dr. Nemeroff was cooperating with the university investigation. Dr. Nemeroff released a statement saying, “To the best of my knowledge, I have followed the appropriate university regulations concerning financial disclosures.”
David Wynes, vice president for research administration at Emory, said that there had been no allegations that the payments to Dr. Nemeroff had biased the depression study. “Our hope would be that as soon as the NIH is confident that we’ve answered any concerns about the grant, they will start the funding for the program again.”
In the wake of the Senate investigation into Dr. Nemeroff, Emory created a new central office to oversee conflict-of-interest issues. It also instituted new disclosure requirements for NIH grantees at the university.
Senator Grassley’s staff has been investigating researchers at 20 universities, focusing primarily on scientists who failed to disclose payments from pharmaceutical and medical-device companies in the fields of psychiatry, cardiology, and orthopedic surgery.
Ezekiel J. Emanuel, chairman of the department of bioethics at the NIH, said there are problems with the system that governs conflicts of interest in biomedical research. “We know the system is broken,” he said. “The safeguards aren’t working. They’re onerous to those who adhere, and they don’t work for those who don’t adhere.”
The solution, however, is not to simply prohibit payments from companies to researchers, he said, because academic scientists must interact with industry in order to translate basic science into treatments. “It’s just that the usual ways of greasing that—money, food, and travel—are corrupting the system. We really need to rethink the system,” he said.
