The Pew Charitable Trusts’ Pew Prescription Project recently released a series of recommendations it believes will ensure transparency in physician-industry relationships and reduce or manage conflicts of interest in academic medical centers. Among them: Medical schools, with “rare exceptions,” should not accept commercial support for continuing medical education; and , students, and trainees should not attend or speak at pharmaceutical, biotechnology, or medical device company promotional meetings.
In addition, other than meals, it recommends that faculty and trainees should not accept any gifts from industry; and at CME activities, even food and beverage should not be accepted.
The Pew report goes on to say recommend that faculty and trainees be allowed to consult with pharma or other life sciences companies for scientific and research purposes, but not for marketing projects. They also should disclose all relevant financial COIs to other faculty and trainees, as well as patients and the public.
The report acknowledges that the Pharmaceutical Research and Manufacturers of America has already covered much of this ground with its PhRMA Code, and that many medical schools and medical centers have already adopted their own policies to govern potential COI. But these recommendations are needed, the report says, because “While institutions can set guidelines and provide a level of oversight and enforcement, it is not clear that these are sufficient to change an individual’s behavior, much of which can occur outside of the institution’s purview.”
Pew suggests that CME should eschew commercial support of live and online lectures or discussions that include treatment recommendations, including drugs or devices. If an academic center absolutely must accept commercial support, it should go above and beyond the Accreditation Council for CME Standards for Commercial Support by “creating a ‘blinded’ pool of industry funds; requiring that any activity be funded by more than one company; calling for physicians to use some of their own money (such as paying for their own meals); and locating the continuing medical education activity within an academic setting or other appropriate venue conducive to education.” The SCS already require financial disclosure, a hands-off approach to content and faculty, and procedures for managing any potential COI.
Medical schools should decide on a case-by-case basis whether to accept support for activities like training on medical devices, which could be prohibitively expensive otherwise and may require the company’s technical expertise to be effective. And they should observe commercially supported training carefully for potential conflicts and bias.
CME Advocates Are Not Pleased
The CME Coalition, a Washington, D.C.–based CME advocacy group, responded to the Pew recommendations with a warning: Because a third of the support for accredited CME comes from industry, the recommendations would eliminate one out of every three dollars that are invested in accredited medical education for docs. The Coalition believes that the premise underlying the recommendations—that commercial support of CME taints the education and negatively impacts patient outcomes—is faulty and unsupported by data.
“It is astounding that a respected institution such as Pew could continue to promote such an irresponsible approach to CME, and that these so-called experts are so willing to sacrifice the ability of doctors to avail themselves of the latest science out of a groundless distrust of physicians and their ability to put patients’ interest first,” says Andrew Rosenberg, CME Coalition’s senior advisor.
The Pew report acknowledges that “the empirical research on bias in industry CME is limited and in some cases outdated,” but it cites three studies that show learners prescribing more of the sponsors’ antihypertensives, antibiotics, and antipsychotics post-activity.
The Association of Clinical Researchers and Educators, which historically has supported industry-physician collaboration, also is asking academic medical centers to reject the Pew recommendations. In a statement, ACRE said, “The Pew recommendations would create severe barriers to routine interactions between producers and consumers of advanced medical technology, including drugs, devices, diagnostics, and cell therapies that have been shown to accelerate the discovery, testing, production, and adoption of breakthroughs, under the watchful eye of FDA and quality system authorities.”
In addition, says ACRE, “the Pew proposals reflect the prejudice of a handful of academic bureaucrats who see cooperation and the promotion of innovation as endeavors beneath the dignity of medicine. The claim that interaction with industry leads physicians to utilize more expensive treatments reveals the true motive of the Pew report, that saving money is more important than saving lives, even when many modern discoveries have been shown to be more economical than older interventions (think of penicillin). The recommendations simply rehash previously failed proposals. (Brennan 2007, Macy 2008, IOM 2009)”
The Pew recommendations, which were drawn up by a group of medical doctors, attorneys, and PhDs, were devised to update the Association of American Medical Colleges’s 2008 conflict policies. The work was funded by a grant from the Attorney General Consumer and Prescriber Education Grant Program, which was established by the multistate settlement of consumer fraud claims regarding the marketing of Neurontin.