Conflicts of Interest, Revisited
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 (see “Controlling Conflicts of Interest,” September-October 2004, page 76), and, the school asserts, the most thorough review since the policies were initiated in 1990. Among the principal changes are measures to:
- disclose publicly all relevant faculty financial interests on the Harvard Catalyst website, and streamline reporting for all faculty members, at HMS proper and 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 academics are, in effect, rented to present information prepared by companies marketing treatments), and disallow compensation for speaking engagements that limit faculty members’ freedom to present content; and
- limit (not end) industry funding for creation and delivery of continuing medical education (CME) course content, and control (not prohibit) how industry advertises or exhibits at such courses.
The new policies will begin taking effect on a rolling basis next January.
COI policies are a particular concern for medical education and research. The report on HMS’s revisions 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 such relationships to “ensure transparency and continued public confidence in the integrity of the scientific enterprise”—no minor feat given heightened public concern over practices such as industry-sponsored ghostwriting of purportedly impartial expert articles, and on-campus marketing to medical students.
The preamble notes that faculty members are encouraged “to engage in a wide variety of activities with industry,” including conducting research sponsored and supported by industry; collaborating with industry on research protocols; consulting; creating biotechnology companies; licensing technology to or from companies; serving on companies’ scientific advisory boards; and holding ownership stakes in medical companies.
Or as Dean Jeffrey S. 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 prohibits it if the investigator has equity ownership in a private company sponsoring the research. Tighter restrictions govern research involving human subjects.
As Flier noted, “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 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”—he observed, “[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 recently banned such gifts for clinical faculty.
The restriction on speakers’ bureaus is part of a widening concern about professors’ educational activities, broadly defined. HMS requires disclosure of faculty members’ permitted financial interests when they give lectures, and limits marketing at educational events. Speakers’ bureaus now appear “inappropriate,” Flier wrote, as part of “explicit marketing events” by companies.
In implementing the ban on gifts and speakers’ bureaus, HMS is coming into line with other schools. Stanford, for example, imposed such policies on its faculty in 2006, and extended them to clinical adjuncts this past spring.
On continuing-education (CME) funding, HMS appears to be choosing a middle path. Such courses, required of doctors to maintain licensure, are a significant business: according to New York Times coverage of the issue, industry funding is estimated to total as much as $1 billion nationwide, amounting to perhaps half of the annual expenditure for CME. In fiscal year 2009, according to HMS data, its CME revenues were $24.9 million, with tuition accounting for 73 percent of the total, commercial support 10 percent, and contractual payments, grants, and other income 17 percent. (In 2008, 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 around the world—an attractive audience for marketers.
Under the new policies, HMS will still accept industry funding for a course—but only if there are multiple sponsors, none funding 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, to be used at the school’s sole discretion.
Further, HMS will continue to allow industry-sponsored exhibits and advertising at CME programs, but such exhibits must now be located in a room separate from the venue where Harvard content is offered, and accessed through a separate entrance. Industry programs associated with CME offerings (seminars, for instance) must now be marketed separately from the course, and cannot be at competing locations or times.
Other institutions are more stringent. Stanford decided in 2008 to prohibit company support for specific CME courses; it limits industry support to broad areas, such as “medical, pediatric, and surgical specialties” or “diagnostic and imaging technologies.” Funding cannot be tied to a particular course, topic, or program, and associated commercial exhibits are banned, on campus or elsewhere. The University of Michigan banned industry funding for CME programs entirely, effective next January.
In reaching its decision, the Harvard COI committee noted that “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…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 sponsorships, the HMS 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.
The full committee report and supporting documents are available at the medical school’s Integrity in Academic Medicine website (hms.harvard.edu/public/coi).