Update on Conflicts of Interest Allegations

March 4, 2009

Two prominent psychiatrists have agreed to curtail their research activities following revelations about sizable consulting fees from pharmaceutical manufacturers.

Two prominent psychiatrists have agreed to curtail their research activities following revelations about sizable consulting fees from pharmaceutical manufacturers.

Joseph Biederman, MD-who has strenuously denied any wrongdoing-agreed to withdraw from industry-financed programs, including clinical trials currently under way, at Massachusetts General Hospital (MGH). He also agreed to stop participating in speaking engagements and other activities arranged by pharmaceutical companies while allegations against him are under investigation. Dr Biederman had been accused of failing to report more than $1.4 million in outside income to MGH, as required by the hospital’s ethics rules. Dr Biederman notes that the disputed income was earned over 8 years from pharmaceutical and nonpharmaceutical sources. He also notes that Harvard and MGH rules on conflict of interest do not prohibit the earning of outside income. He adds that MGH and Harvard do prohibit investigators from earning more than $20,000 per year since 2004 and $10,000 before then, from a company with which the investigator could have a conflict of interest.

Dr Biederman headed MGH’s Johnson & Johnson (J&J) Center for the Study of Pediatric Psychopathology from 2002 to 2005. Congressional investigators have released internal e-mails from J&J officials discussing the company’s involvement in the center. In one e-mail, a company official stated, “The rationale of this center is to generate and disseminate data supporting the use of risperidone in this population,” referring to children and adolescents with bipolar disorder.

In a strongly worded letter to the editor of the Wall Street Journal 10 days before his temporary withdrawal was announced, Dr Biederman said, “The center’s goal was to advance science. As a business, J&J naturally sought commercial applications for our work. But any implication that J&J’s interests interfered with the center’s work is wrong.” He added, “Indeed, I have published research critical of J&J compounds.”

In an unrelated case, Charles Nemeroff, MD, resigned as chair of the Department of Psychiatry and Behavioral Sciences at the Emory University School of Medicine. In addition, Dr Nemeroff has agreed to new restrictions on his outside activities. The university announced that it would not submit any applications for grants involving Dr Nemeroff as an investigator or “any other role” for at least 2 years. This is a restriction imposed by Emory, not NIH. As such, if Dr Nemeroff were to relocate to another institution, he would be eligible to apply for NIH research grant funding. Dr Nemeroff will remain “as a professor and will focus on clinical care, teaching, and other academic pursuits,” the university stated.

Dr Nemeroff had earlier agreed to step down as chair of the department pending an investigation of his outside activities. He relinquished the chairmanship after the Atlanta Journal-Constitution reported that Sen Charles Grassley warned the university “of the potential penalties for making false statements or obstructing a congressional examination.” Grassley’s warning followed the university’s contention that lectures given by Dr Nemeroff for which he was paid by GlaxoSmithKline were “CME-like.” Grassley responded that “neither anyone on my staff, nor any medical expert that they have contacted, has ever heard of the term ‘CME-like.’ It appears to be a new term created at Emory University.”