Psychiatrists Accused

Harvard is among the medical schools re-evaluating its current policies and considering improvements. One catalyst for the review is Sen Charles Grassley (R, Iowa), who accused 3 psychiatrists at Massachusetts General Hospital (MGH), an affiliate of Harvard Medical School (HMS), of violating federal and university research COI policies.

In the June 4 Congressional Record, Grassley claimed that Joseph Biederman, MD, Thomas J. Spencer, MD, and Timothy E. Wilens, MD, of MGH failed to report the full amount they earned from drug companies over a 7-year period. Only after Harvard and MGH asked the psychiatrists to take a second look at the money they had reported receiving, Grassley said, did Biederman admit “to over $1.6 million from the drug companies,” while Spencer admitted to “over $1 million,” and Wilens reported “over $1.6 million.”

Grassley charged that Biederman and Wilens were awarded grants from the NIH to study atomoxetine (Strattera) and “if a researcher is taking money from a drug company while also receiving federal dollars to research that company’s product, then there is a conflict of interest.”

Grassley’s accusations against the psychiatrists were covered in the media, including The New York Times (June 8, 10). Grassley also sent letters to NIH Health Director Elias Zerhouni, Harvard President Drew Faust, and MGH President Peter Slavin requesting further detailed information about the grants and COI procedures by mid-June.

Both institutions are cooperating with Grassley’s investigation, said HMS spokesperson David Cameron, “but we are not releasing our correspondence to the senator in deference to his process.”

According to current policies, HMS faculty members cannot participate in clinical research on a company’s technology (eg, compound, drug, or medical device) and receive consulting fees of more than $20,000 from that company.

HMS Office of the Dean has referred the cases of the 3 psychiatrists to the Standing Committee on Conflicts of Interest and Commitment for review. Its findings and recommendations will be forwarded to the dean for further action. Sanctions can include formal admonition, ineligibility for grant applications, and dismissal from the faculty.

Meanwhile, HMS Dean Jeffrey Flier, MD, announced a new cycle of mandatory COI disclosures for all HMS and School of Dental Medicine faculty, specifically reminding them to include CME speaking engagements and outside activities that relate to their roles as a faculty member regardless of the amount of financial interest involved.

HMS also is evaluating its efforts to educate faculty members about COI rules, reviewing the disclosure forms and re-examining its COI policies as they relate to the institution, individuals, and special issues presented by clinical research.

This fall, Harvard is planning a university-wide review of its policies on COI. At MGH, Slavin with David Torchiana, MD, chairman and chief executive officer of the Physicians Organization, in a joint letter said that MGH is undertaking a “thorough internal review of all the issues” raised by Grassley. Also, MGH leadership, they said, is participating in a taskforce initiated by Partners HealthCare, the hospital’s parent organization. The taskforce will examine and, if necessary, revise MGH’s policies relating to its interactions with industry.

In their own defense, the 3 psychiatrists have issued public statements. “I have devoted my entire career to scientific research that benefits the sick and suffering. My interests are solely in the advancement of medical treatment through rigorous and objective study,” said Biederman. “I have cooperated fully with all requests for information from Senator Grassley, as communicated through the institutions that employ me. Through my full and complete disclosure of the requested information, I hope that Senator Grassley will recognize my long-term intention to comply fully with and adhere to the conflicts of interest policies of those institutions. I have always taken those policies very seriously and will continue to do so for the rest of my career.”

Wilens noted, “Speaking to colleagues at conferences and other gatherings is one of the best ways to discuss developments and share ideas in the treatment of children with ADHD and other similar disorders. In accepting these invitations to speak, and in what I reported on my disclosure forms, I have always believed that I was acting within the applicable relevant guidelines and rules.”

Spencer talked of his deep commitment “to helping children with ADHD and other similar disorders find treatments that can help improve their lives. Presenting the findings of our clinical trials to other doctors in this field at conferences helps to keep them up to date on the latest developments and generate new ideas. It was my sincere belief that I was at all times complying with the relevant policies and procedures as to outside income.”

“Sweeping changes are under way at Harvard Medical School,” observed Stone.

“It seems clear to me that the most important issue for psychiatrists and their patients is the scientific rigor and validity of the published research itself. I have good reason to believe that the economic influences cited by Senator Grassley did not bias this important clinical research, but such assurances need to come from those who are more qualified to speak.”

Less confident in the research is E. Fuller Torrey, MD, executive director of the Stanley Medical Research Institute, a nonprofit organization supporting research for schizophrenia and bipolar disorder.

“There is no question that industry sponsorship affects the results of drug trials, and this has been well documented,” he said, noting that “tainted research” is of “limited usefulness.”

“Insofar as psychiatrists are known to be taking gifts and favors from drug companies,” he added, “it seriously undermines patient trust in their psychiatrist.”
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