Sen. Grassley issues report on conflict-of-interest probe into improper payment disclosures by three Harvard psychiatrists

Three well-known psychiatric researchers from Harvard Medical School may have violated federal and educational institution regulations by failing to properly disclose drug industry payments and other conflicts of interest, according to an investigation report published last week by Sen. Chuck Grassley (R-Iowa) in the Congressional Record, the Wall Street Journal reports (Armstrong, Wall Street Journal, 6/9).

According to the New York Times, the group's "consulting arrangements with drug makers were already controversial because of the researchers' advocacy of unapproved uses of psychiatric medicines in children" (Harris/Carey, New York Times, 6/8).

As part of the investigation, Grassley's staff compared the payment records provided by drug companies with disclosure forms that the three psychiatrists -- Joseph Biederman, Thomas Spencer and Timothy Wilens -- filed with the university and their employer, Massachusetts General Hospital. According to the Journal, the analysis showed that between 2000 and 2007, the three researchers had incomes of a "couple hundred thousand dollars." However, when pressed by the university and the hospital to examine their payment records, Biederman and Wilens provided adjusted data showing that they had received more than $1.6 million each in total payments from the drug companies, Grassley said. Spencer reported more than $1 million in payments (Wall Street Journal, 6/9).

Grassley said he believed the payments may be higher than reported because the investigation analysis showed that the adjusted payment amounts were still lower compared to the drug companies' records. "Basically, these forms were a mess," Grassley said in comments included in the report (New York Times, 6/8). He wrote, "Why weren't Harvard and Mass General watching over these doctors?" adding, "The answer is simple: They trusted these physicians to honestly report this money" (Wall Street Journal, 6/9). Grassley said the investigation of improper payment disclosures showed that there is a need for a national reporting system that would track drug industry payments to researchers.

Comments

In an e-mail responding to the report, Biederman said, "My interests are solely in the advancement of medical treatment through rigorous and objective study." He added that he takes policies concerning conflicts of interest "very seriously." Wilens and Spencer -- in a separate statement -- said they thought they had met the requirements under the conflict of interest rules.

Alyssa Kneller, a spokesperson for Harvard University, in a statement said, "The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed." Kneller said the three researchers were under review by a university conflict committee.

John Burklow, a spokesperson for NIH, said, "If there have been violations of NIH policy -- and if research integrity has been compromised -- we will take all the appropriate action within our power to hold those responsible accountable," adding, "This would be completely unacceptable behavior, and NIH will not tolerate it" (New York Times, 6/9).