Harvard will stiffen rules for staff at med school
Conflict of interest will be redefined
Harvard Medical School plans to strengthen its conflict-of-interest rules for doctors and researchers, amid a US Senate investigation into several faculty members and a new state law that will make public some of the payments doctors receive from pharmaceutical and medical-device companies.
Many top medical schools, including Stanford University, the University of Pennsylvania, the University of California at Los Angeles and at San Francisco, and the University of Massachusetts have adopted stricter policies in the past two years. Last year, the American Medical Student Association graded Harvard with an F on its conflict-of-interest policy because it does not address issues like whether companies can provide gifts and meals for faculty.
But Dr. David Korn, Harvard University's vice provost for research and a nationally known leader on conflict-of-interest policies, said Harvard's job is considerably more challenging, because the medical school does not own or control its affiliated teaching hospitals, where clinical faculty members see patients and interact with drug company salespeople. And most clinical faculty are employees of the hospitals, not the medical school.
"I personally would like to see the medical profession above public reproach to the maximum extent possible," said Korn, who was hired several months ago and will oversee a review of all the university's conflict-of-interest policies, including those at the medical school. He said the gifts doctors receive from drug companies "are unnecessary and distracting and in some ways demeaning to the medical profession." But the medical school "has to bring the hospitals along with it," he said.
Harvard's teaching hospitals, including Massachusetts General, Brigham and Women's, and Beth Israel Deaconess Medical Center, each have their own conflict-of-interest rules, which overlap with but are separate from those for Harvard Medical School.
The medical school's policy focuses on limiting research conflicts; for example, it bars faculty or their family members from holding more than $30,000 worth of stock in publicly traded companies, and any equity in privately held companies that sponsor their research, or from receiving more than $20,000 a year in consulting or other fees. The hospital policies generally cover research conflicts but also set rules for whether drug companies can provide meals for doctors during educational talks and give them gifts. Doctors are required to fill out various forms for the hospitals and medical school each year, disclosing many of their relationships with industry.
A 19-member committee will review the entire policy, which could take a year, said the medical school dean, Dr. Jeffrey Flier. He said that the policy is revised regularly - most recently in 2004 - and that the current review was not prompted by the Senate investigation or the new state law. US Senator Charles E. Grassley, a Republican from Iowa, has accused three Mass. General psychiatrists of not fully disclosing payments they received from drug companies for consulting and other activities. The doctors have said they believed they complied with the rules. Harvard Medical School and Mass. General are conducting their own investigations.
"The public and regulatory agencies are saying we have to be much more transparent about any relationships faculty have with industry," said Dr. Richard Schwartzstein, a member of the review committee and a pulmonologist at Beth Israel Deaconess. "The trend is to become more and more stringent, there's no question about that."
Flier said one area the committee probably will focus on is continuing medical education. The medical school sponsors several hundred courses for doctors each year, Harvard officials said, and drug companies pay about 13 percent of the cost. He said the medical school does not allow pharmaceutical companies to influence the content of courses. But some medical schools have adopted additional safeguards against industry influencing education for physicians, such as requiring companies to give money to a central office, which then distributes it to pay for courses. Others are discussing banning industry funding altogether.
"I don't think we need to go there," Flier said, about entirely barring company funding for education. "If you have the appropriate separation between the source of funding and the speakers and the topics, it's not a problem in my point of view."
Harvard also is under pressure from some medical students demanding stricter rules. Last year, a group of students pushed for and won a new policy requiring lecturers, faculty members, and visiting professors to disclose any financial interests they have in a company or treatment they discuss. Students say enforcement of the policy is spotty.
"We do see that interaction between industry and [doctors and hospitals] can be very beneficial in providing new therapies," said one of the students, Kirsten Austad. "But when it's not above board it can create mistrust between patients and doctors."
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