Harvard Medical School's 11,000 faculty will face stricter regulations governing their relationship with pharmaceutical and medical device-making companies starting January, under a new policy designed to prevent conflicts of interest with industry.
The new conflict-of-interest rules, unveiled Wednesday after an 18 month-long review, prohibit faculty from accepting personal gifts and giving industry-sponsored talks at events where the material is prepared in advance by the company.
In addition, the cap on faculty compensation from outside companies has been cut in half to $10,000 annually, when the faculty member is conducting research on technology owned or licensed by a given company.
“As an academic field of review, conflict of interest is changing,” said Gretchen A. Brodnicki, the school's Dean for Faculty and Research Integrity who led the 34-member review committee. “Our understanding of what is or is not a conflict now may change in a year, a year and a half, or two years from now.”
The policy revisions follow a period of national scrutiny, during which Harvard Medical School and its peer institutions have come under fire for several high-profile cases of undisclosed industry ties.
Senator Charles E. Grassley, an Iowa Republican and the ranking member of the Senate Finance Committee, first reported in June 2008 that psychiatrist Joseph Biederman of Harvard-affiliate Massachusetts General Hospital received $1.6 million in consulting and speaking fees from the makers of drugs that he used to treat children for bipolar disorders.
As Grassley continued his investigations of several Harvard physicians, a band of Harvard Medical School students pushed the administration to tighten its conflict-of-interest rules, calling for a comprehensive policy spanning the school's affiliated hospitals.
While Brodnicki said the school regularly updates its conflict-of-interest policies—the last such review took place in 2004—the committee's recommendations go beyond the scope of the existing policy to include continuing medical education and public disclosure of financial interests, among other issues.
"This is the most comprehensive set of revisions to the policy in quite some time," Brodnicki said.
Crafting a policy that curbs potential conflicts with industry without hampering positive collaborations between faculty and companies is essential, as such work often leads to key developments in clinical research, said David T. Grande, a member of the National Physicians Alliance Board of Directors and professor at UPenn's School of Medicine.
"These relationships are important and ought to continue," said Grande, who was not involved in the school's internal review. "But they have to be done in a way that protects the scientific process."
News of Harvard's revised policy was met with encouragement from student advocacy groups that have voiced their concerns over the past few years about proper disclosure of financial interests and the rigor of conflict-of-interest policies across medical schools.
“I think this relationship between academia and industry is constantly in flux, and so we hope that these policies can be mutable,” said Nitin Roper, a former chair of the American Medical Students Association PharmFree Campaign, which urged medical schools to tighten their conflict-of-interest policies. "We don’t want institutions like Harvard to stick to old ways.”
As Harvard Medical School starts phasing in the new policy, Brodnicki said that she expects to meet some resistance from faculty.
“Not everyone will agree with each element of this report,” Brodnicki said, adding that she looks forward receiving feedback on the policy changes. "That’s very much an important part of our process and our culture.”
—Staff writer Xi Yu can be reached at email@example.com.
This article has been revised to reflect the following clarifications:
CLARIFICATIONS: July 21, 2010
An earlier version of the July 21 news article "Harvard Medical School Restricts Faculty Ties to Industry" stated that the University's new conflict of interest policies prohibit faculty from giving industry-sponsored talks. To clarify, faculty are prohibited from participating in engagements where they are paid to give a talk for which the material is prepared in advance by the company.
The article also stated that the cap on faculty compensation from outside companies has been cut in half to $10,000 annually. To clarify, this prohibition only applies if the faculty member is conducting research on technology owned or licensed by a given company.