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Harvard Medical School To Reexamine Conflicts of Interest Policy

Reevaluation comes amid allegations of unreported income against three Harvard psychiatrists

By June Q. Wu, Crimson Staff Writer

Following allegations that three Harvard physicians violated federal and university research conflict-of-interest policies, Harvard Medical School will be assessing its current regulations and improving implementation.

Senator Charles E. Grassley, an Iowa Republican, brought to light possible conflicts of interest earlier this month when he revealed that psychiatrists Joseph Biederman, Thomas J. Spencer, and Timothy E. Wilens of Mass. General Hospital failed to report the full amount they earned from drug companies over the last seven years, according to the senator's investigation.

Biederman and Wilens admitted to earning over $1.6 million from pharmaceutical companies last March when Harvard and Mass. General asked the Medical School professors to "take a second look" at the income they received from consulting since 2000. The total was previously reported as a couple hundred thousand dollars, according to the Congressional Record. Spencer also belatedly reported earning at least $1 million.

All three Harvard researchers could not be reached for comment, and a spokesman for Mass. General said that the doctors had not released any statements as of last week.

David J. Cameron, a spokesman for the Medical School, said that the School's Standing Committee on Conflicts of Interest and Commitment, headed by professor Robert J. Mayer, will be reviewing the doctors' cases. Mayer declined to comment last week, as the committee's proceedings are confidential.

Cameron added that the Medical School will be increasing awareness of conflict-of-interest rules and reviewing its financial disclosure forms.

Additionally, the Medical School will also be participating in a University-wide review of its conflict-of-interest policies scheduled for the fall.

Harvard spokesman John D. Longbrake said that the provost and University deans decided last fall that "with the growth in cross-school initiatives, conducting a thorough, University-wide examination of Harvard's conflict of interest policies was necessary."

The review will examine conflict policies at the individual schools, institutional conflict policy, and special issues present by clinical research, Longbrake added.

Under current policies, faculty members at the Medical School cannot participate in clinical research on company's technology and receive consulting funds of more than $20,000 from that company.

"We believe the disclosure process and financial prohibitions—in conjunction with the requirement that no more than 20 percent of a full-time faculty member's total professional effort may be directed to outside work—address the overwhelming majority of conflict concerns," Cameron said in a statement released by the Medical School.

But Biederman and Wilens were awarded grants from the National Institutes of Health (NIH) to study Eli Lilly's drug Strattera.

Grassley sent letters to NIH Director Elias A. Zerhouni, Harvard President Drew G. Faust, and Mass. General chief Peter L. Slavin earlier this month asking for detailed information about the grants to be submitted no later than Wednesday.

Norka Ruiz Bravo, the deputy director for extramural research at NIH, declined to comment on the specifics, stating that NIH is still trying to determine what exactly has transpired.

"I want to reiterate that if in fact there has been a violation of NIH policy, if in fact research integrity has been compromised, we will take whatever appropriate actions within our power to hold whoever is responsible accountable," Ruiz Bravo said. "We cannot compromise research integrity and we must maintain public trust."

Ruiz Bravo added that depending on the outcome of the investigation, the NIH could take a number of actions ranging from placing the grants in question under "special monitoring" to suspending the funds.

Grassley, who had been looking at the financial relationships between physicians and drug companies recently, is asking the NIH to "take a closer look" at the grants they give to researchers.

"Every year, the NIH hands out almost $24 billion in grants," Grassley said in a floor speech. "But nobody is watching to ensure that the conflicts of interest are being monitored."

Since most research institutions and medical centers establish their own conflict of interest policies—the Medical School's policies are independent of those of its affiliated hospitals—Grassley is pushing for a set, national standard.

Last fall, Grassley and Senator Herbert H. Kohl, a Wisconsin Democrat, introduced the Physician Payments Sunshine Act, which will require companies to report payments that they make to doctors. Legislation for the Sunshine Act, which has recently secured endorsements last month from pharmaceutical companies such as Eli Lilly, AstraZeneca, and Merck, is currently pending.

According to Grassley, transparency in such financial relationships would decrease the chances of universities violating NIH regulations on conflicts of interest.

"NIH is supposed to be aware of conflicts of interests when it distributes grant money to doctors," said Jill Kozeny, a spokesman for Grassley. "And what Senator Grassley talked about on the floor last week illustrates that NIH is not aware of relationships that it arguably should be."

—Staff writer June Q. Wu can be reached at junewu@fas.harvard.edu.

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