Yesterday, Harvard Medical School announced strict conflict-of-interest rules that limit ties between its 11,000 faculty members and pharmaceutical and medical device makers, making it one of a growing number of medical schools across the country to address concerns about the influence of industry marketing on the education, training and practice of physicians.
Highlights of the new policy, which will be phased in by January 1, 2011, include:
- prohibiting all personal gifts, travel or meals from industry
- banning participation on speakers bureaus (company-controlled talks)
- capping at $10,000 annually per company the amount faculty can earn from a company whose technology or product they are investigating in clinical research
- requiring Harvard to post on its website faculty member financial interests in, or payments from, pharmaceutical and medical device companies
- prohibiting companies from sponsoring specific Harvard-run CME courses for physicians, unless more than one company sponsors the course and no one company funds more than 50 percent
- requiring industry exhibits and programs to be held at a separate time and place from Harvard CME courses
As one of the world’s most prestigious medical education and research institutions, Harvard’s decision to strengthen its rules is a powerful acknowledgement of the impact of aggressive industry marketing on medicine. It also sends a strong signal to other institutions that have yet to address industry’s presence on medical campuses. It is also a reminder to the Massachusetts legislature, which is debating efforts to repeal the state’s ban on industry gifting to prescribers, that the medical profession is increasingly embracing the need for these restrictions and ethical standards.
When the Prescription Project formed in 2007 with a goal of eliminating conflicts of interest at academic medical centers, conventional wisdom had it that change at Harvard and its affiliated hospitals would not come easily. After Boston University and UMass Memorial Medical Center released strong policies in 2007 and 2008 respectively, the Project convened all of the Boston-based academic medical centers with the hopes of building momentum for change at all of the Massachusetts-based schools and teaching hospitals.
Harvard’s new policy buttresses similar guidelines issued last year by Partners Healthcare, which employs thousands of Harvard physicians and operates two of Harvard’s teaching hospitals – Mass General and Brigham & Women’s.
As a number of other top institutions around the country – Stanford, University of Pittsburgh, University of California Davis – released new COI policies in 2008 and 2009, attention continued to focus on Harvard. A series of unflattering media exposés on Harvard physicians’ ties to industry, followed by a Congressional investigation by Senator Charles Grassley (R-Iowa) into whether the physicians had violated federal conflict-of-interest payments for failure to disclose large drug company payments, raised questions about the school’s policy and helped thrust the issue into the national spotlight.
In June of 2008, the American Medical Student Association (AMSA) released its Pharmfree Scorecard developed in partnership with the Pew Prescription Project. Harvard received an “F” score due to its failure to submit its policy. The score garnered unwanted media attention from several major national news outlets.
In addition to creating external pressure on Harvard, AMSA began to work internally to push for reform and signs of progress were beginning to surface. When the Harvard University Faculty of Medicine Committee on Conflicts of Interest and Commitment convened in late 2008, AMSA members from Harvard Medical School and across New England asked for involvement in the policy drafting process, increased transparency, mandatory lecturer disclosure and a reasonable timeline for drafting and implementation.
Last year, Harvard submitted policies to AMSA and received a “B” score on the 2009 Pharmfree Scorecard.
“Harvard’s policy represents an important milestone because many institutions look to Harvard to set an example,” said Chris Manz, Pharmfree Director at AMSA. “While the policy revision has room for improvement, it sends the message that academic medical centers can responsibly collaborate with industry while also preserving the integrity of the medical practice, and we’re proud that PharmFree students played an integral role in its development”
In some areas, Harvard’s new rules may set standards for other schools, particularly in the area of faculty earnings from industry. The rules cap at $10,000 the amount Harvard faculty can earn from a company whose technology or product they are investigating in clinical research.
Despite that, the new rules on continuing medical education (CME) do not go as far as those at schools like UMass and Stanford, which the Project has cited as model policies. Nevertheless, it will be interesting to see how the CME policies impact Pri-Med, the Boston-based annual physicians conference that features Harvard lecturers and has been a carnival of industry marketing. The new rules propose a “firewall” between Harvard and the companies that use these events to market their wares in every spot imaginable, including, apparently, the bathrooms, which will no longer be allowed.
Overall, these are strong policies that will be hugely influential.
– Kathy Melley, Director of Communications