“Emory’s swift and sure-footed response sets an example for other research institutions to follow and for the National Institutes of Health (NIH) to hold up as the kind of standard it expects from all those receiving federal research dollars. Accurate disclosure and transparency are fundamental to the integrity of medical research. Without them, the public trust is violated and public confidence in the system is legitimately shaken.” (Senator Charles Grassley on Emory’s announcement 12-22-08)
After two years of investigations and letters, Senator Grassley has won a major victory in his quest to weed out all undisclosed conflicts of interests with medical researchers at university medical centers.
Today, Emory University announced they were meeting the demands of Senator Grassley and permanently demoting Dr. Charles Nemeroff from his chairmanship of the Department of Psychiatry.
In their statement, Emory said they had conducted an investigation into allegations of conflicts of interest involving Dr. Nemeroff, the long-time Chair of the Department of Psychiatry and Behavioral Sciences at the Emory University School of Medicine.
· Emory faulted Dr. Nemeroff for failing to seek clarification if he believed the policies were ambiguous.
· Emory found no evidence that Dr. Nemeroff’s outside activities affected clinical care for patients or persons enrolled in clinical trials and no evidence that his activities biased scientific research in which he was engaged.
The conditions for Dr. Nemeroff are outlined in the letter to NIH :
· He will permanently give-up his chairmanship of the Department of Psychiatry that he has held for 17 years
· Emory will not submit any NIH or other sponsored grant or contract request with Dr. Nemeroff listed as an investigator for two years from the date he stepped down as Chairman of the Department (October 3, 2008)
· Will cooperate fully with Emory on this investigation
· Must report and gain prior approval from the Dean’s Office for all external compensation
· He can only serve on four external advisory boards and is limited to $10,000/year in compensation
· Non-compensated interaction with biomedical companies to further science must be approved by the Dean’s Office
· He may accept invitation to lecture at other academic institutions and meetings hosted by professional societies with approval by the department chairman
· If he receives compensation from societies or institutions, he must report this to the Dean’s Office
· He is prohibited from speaking at any other event, unless it is an Accreditation Council for Continuing Medical Education (ACCME)-accredited educational event, hosted by an academic institution or medical society
· His honorarium may not exceed $2,500/event plus reasonable travel
· If Dr. Nemeroff hosts a continuing medical education (CME) event for which he is the course director, it must be ACCME-accredited and fully compliant with the University’s CME policies.
· He cannot receive gifts (private donors) directly but only through the University
· He may accept compensation and travel from NIH or other federal agencies for serving on study sections, review panels, commissions, and similar activities as long as it is reported to Emory
· He is required to adhere to Emory’s healthcare policies regarding prescribing, vendor relationships, conflict of interest reporting, and receipt of pharmaceutical samples
· He has to keep track of this information himself (they may want to get him some help).
In their statement, Dr. Nemeroff stated that “I regret the failure of full disclosure on my part that has led to the current situation,” he said. “I believe that I was acting in good faith to comply with the rules as I understood them to be in effect at the time. I pledge to continue my cooperation in working with Emory to clarify and strengthen our current system of disclosure here and throughout academic medicine.”
Dr. Fred Sanfilippo, Emory’s Executive Vice President for Health Affairs, noted that “universities traditionally depend on the integrity and voluntary cooperation of our faculty to meet the public trust to which we all strive.”
“To strengthen this approach, we strongly support the public reporting by pharmaceutical and medical device companies of all payments to academic physicians and researchers,” he said. “With access to a common set of data, medical schools, lawmakers, and most importantly, the general public, will have the transparency needed to ensure objectivity and accountability in biomedical research, clinical practice, and educational activities.”
In the end, Emory had little choice but to sanction Dr. Nemeroff, albeit severe restrictions, they were facing the threat of losing additional NIH grants and subsequent negative grant bias. The negative publicity that would have cost the University millions of dollars due to lost reputation is immeasurable.
The lesson here is simple, if you are a university faculty member, you need to be diligent in meeting the reporting requirements of your university or face certain public humiliation at the hands of Senator Grassley.
Senator Grassley: Comments on Emory’s Statement to NIH 12-22-08
EmoryUniversity: Emory University Press Announcement – Nemeroff – 12-22-08
