Harvard Medical School (HMS) on July 21 announced changes in its policies governing faculty members’ financial conflicts of interest and commitment (COI). This is the first such comprehensive revision since 2004, and, by the school’s account, the most thorough review since the policies were initiated in 1990. Among the principal changes introduced are measures to:
- disclose publicly all relevant faculty financial interests on the Harvard Catalyst website, and streamline and coordinate reporting for all faculty members, whether at HMS proper or in the affiliated hospitals (where thousands of faculty members holding clinical appointments are based);
- prohibit all personal gifts, travel, or meals from industry (other than travel and meals made available in the course of allowed activities), consistent with recently enacted Massachusetts law;
- prohibit faculty participation in industry-sponsored speakers’ bureaus (where academic experts are, in effect, rented to present information prepared and provided by companies which are marketing treatments), and disallow compensation for any speaking engagement that limits a faculty member’s independence in presenting content; and
- limit (but not end) industry funding for creation and delivery of continuing medical education (CME) course content, and control (but not prohibit) the ways in which industry can advertise or exhibit at such courses.
The new policies and practices will begin taking effect on a rolling basis next January. On the medical school’s Integrity in Academic Medicine page, find the HMS news release; a message from Dean Jeffrey S. Flier (who accepted all of the committee recommendations); the text of the 64-page report of the Faculty of Medicine Committee on Conflicts of Interest and Commitment (delivered to Flier on March 16); and other materials.
COI policies are a particular concern for medical education and research. The committee’s report notes, in its preamble, that the COI policy has always aimed to reinforce “an essential principle: interactions between academia and industry are crucial to science and to facilitating the translation of knowledge from the research bench to the hospital bedside.” The challenge comes in reinforcing that principle “while also providing guidance in structuring relationships between academia and industry to ensure transparency and continued public confidence in the integrity of the scientific enterprise”—no minor challenge in light of public concern over practices such as commercial, industry-sponsored ghostwriting of purportedly impartial expert articles, and on-campus marketing to medical students. The preamble continues:
[W]e encourage faculty to engage in a wide variety of activities with industry, including, but not limited to:
- Conducting research sponsored and supported by industry;
- Collaborating with industry on research protocols and co-authoring publications derived from these collaborations;
- Consulting for industry;
- Founding biotechnology companies;
- Licensing technology to or from pharmaceutical, medical device, and biotechnology companies;
- Serving on the scientific advisory boards of pharmaceutical, device, and biotechnology companies; and
- Holding equity in pharmaceutical, device, and biotechnology companies.
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Or as Dean Flier put it in a related message to the faculty:
The majority of our sponsored research derives from federal sources, such as the National Institutes of Health, but research supported by industry plays an increasingly important role in our research programs. Why? Funding from federal and nonprofit sources is inadequate to support many meritorious proposals, and companies have the resources and interest and can provide reagents, techniques, and expertise not otherwise available. So far, so good. Since industry-sponsored research may involve bench research or patients, the existing policy and new revisions are tailored differently for the two varieties. In both cases, however, the terms must protect the appropriate academic freedoms of our faculty.
For all industry-sponsored research, HMS limits faculty members’ financial interest in a company sponsor—and such research remains prohibited if the faculty member has equity ownership in a privately held company that is sponsoring the research. Tighter restrictions govern research involving human subjects. The aim, Flier wrote, is to “limit the actual and perceived potential for financial-induced bias while permitting robust industry sponsorship of both basic and clinical research.”
The Revised COI Policies
It is in this context—encouraging academic-industry collaboration, but establishing clear rules for such interactions—that the significant new recommendations are being adopted.
As Flier put it in his message, “In all cases where financial interests are involved, an essential antidote to potential harm is transparency, and so disclosure of relevant financial interests internally—and for the first time, publicly—will address this concern.” Hence the new, comprehensive public reporting of financial interests for all faculty members.
As for gifts—which, Flier wrote, now range “from pens and pads bearing company logos, to fancy dinners, to tickets to sporting events, to lavish junkets to discuss new therapies”—they have become more prevalent and, he wrote, “[I]t is hard to see the value of such practices when compared to their negative appearance and potential harm.” They are now prohibited outright. Massachusetts had recently banned such gifts for clinical faculty.
The restriction on speakers’ bureaus is part of a widening concern about faculty members’ educational activities, broadly defined. HMS requires disclosure of faculty members’ permitted financial interests at the time they give lectures, and limits marketing during educational events. The speakers’ bureaus now appear “inappropriate,” Flier wrote, as part of “explicit marketing events” by companies.
In implementing the ban on gifts and on participating in speakers’ bureaus, HMS is now coming into line with practices at other schools. Stanford University School of Medicine, for example, imposed such policies on its faculty in 2006, and extended them to clinical adjuncts this past spring.
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Academic medical centers have adopted differing policies on continuing medical education (CME) funding, and here HMS appears to be adopting a middle course. CME (required by doctors to maintain licensure) is a significant business for the medical school: in fiscal year 2009, according to HMS data, CME revenues were $24.9 million, with tuition accounting for 73 percent, commercial support 10 percent, and contractual payments, grants, and other revenues 17 percent of the total. (In the prior year, the total was $26 million, with tuition accounting for 70 percent, commercial support 12 percent, and other sources 18 percent of revenues.) HMS offered some 263 courses in 2009, enrolling more than 60,000 healthcare professionals from the United States and around the world—a significant audience, and an attractive one for marketers.
Under the new HMS policies, industry funding for a course will still be accepted—but only if there are multiple sponsors, no one of which funds more than 50 percent of a course budget. In addition, the school will establish a dean’s fund to accept general industry support for CME, the funds to be used at the sole discretion of the school.
Further, HMS will continue to allow industry-sponsored exhibits and advertising at Harvard CME programs, but under new conditions: industry exhibits will now have to be located in a room separate from the venue where Harvard CME content is offered, and must be accessed through a separate entrance. Industry programs associated with such CME offerings—seminars, for instance—will have to be marketed separately from the course, and cannot be at competing locations or times.
Other institutions have chosen different kinds of restrictions, some of them more stringent than those announced by HMS. Stanford decided in 2008 to prohibit company support for specific CME courses; rather, it limits industry support to specific areas, such as “medical, pediatric, and surgical specialities” or “diagnostic and imaging technologies.” Funding cannot be tied to a specific course, topic, or program. And associated commercial exhibits are banned from Stanford CME events, whether on campus or elsewhere.
The University of Michigan Medical School banned industry funding for CME programs entirely, effective next January. According to New York Times coverage of the issue, such funding is estimated to total as much as $1 billion nationwide annually, amounting to perhaps half of the total expenditure for CME courses.
In reaching its decision, the Harvard COI committee noted “the complicated history of industry support for educational activities….Some companies have clearly used sponsorship of educational sessions inappropriately, namely, to attempt to increase market demand for company products and, at times, to promote uses beyond a product’s Food and Drug Administration indication.” But failures of compliance shouldn’t “necessarily be interpreted to mean that all industry sponsorship of CME is biased and inappropriate. In fact, we have found little research or definitive data from the HMS, HSDM [School of Dental Medicine], or elsewhere proving one way or the other that industry-supported CME is generally more biased when required safeguards are imposed. Yet even the idea that some in industry may have advanced their marketing goals through the use of CME programs has tarnished academia’s trust in commercial support for CME.”
Acknowledging that other peer institutions have banned commercial sponsorship of CME, the Harvard committee found “that when appropriately managed, industry remains an important resource for funding of high-quality CME.” Hence, Harvard’s continued acceptance of industry funding, under the new guidelines now being adopted.