Abe Lincoln would barely recognize the congressionally chartered National Academy of Sciences (NAS) that, with the stroke of his pen, was unleashed to “investigate, examine, experiment, and report upon any subject of science or art” at the behest of any government department or agency. In 1970, the non-profit Institute of Medicine (IOM) was added to the now-Academies, possessing the same extra-governmental status as the others, in order to “ensure scientifically informed analysis and independent guidance.”
IOM’s mission? “To serve the nation.” Its funding source? Government agencies like the National Institutes of Health (NIH) — and private foundations like the Josiah Macy, Jr. Foundation, which are not contributing so much to serve the nation as to advance their own particular agendas (which is only natural). Ironically, the Macy Foundation (no relation to Macy’s department store) is funding IOM research in hopes of realizing its dream of ending private funding of continuing medical education. For Macy, conflict of interest is apparently in the eye of the beholder: Private funding is bad — unless it comes from the foundation and its handpicked experts who espouse an anti-industry ideology.
The foundation is part of a small, interlocking coterie of bureaucrats and journal editors on the sidelines of medicine who hold the anachronistic view that the healing arts are above the simple business of the world. Like Don Quixote obsessively pursuing his “impossible dream,” they view collaboration with the biopharmaceutical industry as, ipso facto, corrosive to medicine. This view gained support in the ’80s, when biomedical advances expanded the horizons of diagnosis and treatment, making possible products such as the hepatitis B vaccine — not to mention the biotechnology industrial revolution — with the help of physicians and scientists.
This watershed moment, says Thomas Stossel of Harvard Medical School, should have signaled to doctors and academics that cooperation with industry improved patient care. But a few adverse incidents — for example, the allegations of improper marketing against Warner-Lambert regarding the drug Neurontin — were enough to launch and sustain an ethical-purity movement couched in terms of professionalism.
While first directed at research, the drive shifted three years ago to continuing medical education (CME), the purpose of which is to keep physicians abreast of new developments in their field. Macy is worried about the drug industry’s influence on these programs: If a pharmaceutical company funds a CME event, doctors in attendance may be influenced to prescribe that company’s products. So, Macy’s goal is to excise private funding of CME, even though these dollars represent some 50 percent of CME funding; rules preventing consequent bias are currently in place; and some doctors (especially in rural areas) have limited resources with which to pay for this training themselves. The Macy Foundation’s president, George E. Thibault, says that to replace the funding, “some combination of medical schools, health-care systems, health-profession organizations — but all done by the profession — would be the appropriate way to go.”
This is a pipe dream. Without private funding, physician education on new medical innovations would slow to a crawl, harming patients and doctors alike.
POT, MEET KETTLE
Macy and the IOM both flunk the disclosure process they self-righteously demand of industry. The issue isn’t that Macy’s point of view is illegitimate, or that private funding of the IOM (or any academic medical center for that matter) is inappropriate. What is damning is that they are dedicated to pushing private industry out of CME in the name of an entirely self-serving definition of “bias” that reaches predetermined conclusions.
For instance, Macy helped fund IOM’s “Final Report of the Conflict of Interest in Medical Education, Research and Practice Committee,”released April 28, which largely mirrors Macy’s goals for CME, developed at its $300,000 conference in Bermuda in November 2007.
While the Bermuda breezes were blowing, leading conflict-of-interest purists opined on “Continuing Education in the Health Professions.” The conference chairman’s summary report, “Improving Lifelong Learning Through Continuing HealthCare Education,” called for the immediate elimination of private medical education and communication companies (MECCS), and the five-year elimination of pharmaceutical and device commercial support for CME. It was silent on what sources of funding would replace commercial support.
Now comes the IOM committee with its report declaring that “the current system for financing accredited continuing medical education relies too heavily on industry support and needs to be overhauled to be free of industry influence and provide high-quality education” (emphasis added).
The IOM report emphasized that no hard evidence exists concerning the allegedly corrosive influence of industry payments and perks, and highlighted the beneficence of collaboration with industry. Yet, for reasons known to the committee alone (since transcripts are off-limits, with many of the sessions behind closed doors), it recommended the most exacting reforms to date concerning the financing of accredited CME — including a congressionally mandated website disclosing all industry payments.
To further illuminate the effort to purge conflicts of interest from medicine, comically riddled with its own conflicts of interest, it’s useful to look at the IOM report process — and how this supposedly “independent” entity blithely adopted its own funders’ ideological bias.
THE REPORT PROCESS
According to IOM, Macy provided $75,000 to the IOM Conflict of Interest Committee, which cost $1.375 million (the lion’s share of the rest came from NIH [$500,000] and IOM [$200,000]). But “we don’t recommend the results of the work,” says Thibault. “We identify this as an important area that needs new insights and needs advances. But we don’t dictate the outcome of the work that we fund.”
Thibault is keen on the word “dictate.” When we spoke, he used variations of it six times to emphasize Macy’s detachment. Indeed, there are limitations in place to restrain private funders’ influence on the IOM. But the alignment of IOM’s recommendations with Macy’s raises the question of whether these restrictions are strong enough, or, if, in fact, with a wink and a nod, they are ignored.
All final decisions about committees and reports rest with IOM. But, according to the IOM website, sponsors are encouraged to suggest types of expertise and perspectives, and even name individuals, for committees. Thibault, however, insisted that Macy did not recommend individuals, nor did IOM even give the foundation the opportunity to do so; but he also said, “They may ask our opinion, but we don’t get to determine the members of the study group, and we shouldn’t.”
It must be mere coincidence, then, that committee member Eric G. Campbell (of the Harvard Institute of Health Policy) was mentored and supervised by former Macy trustee David Blumenthal of Harvard Medical School (who now heads Pres. Barack Obama’s electronic-medical-records initiative). Campbell presented his views to the panel at its maiden meeting on Nov. 5–6, 2007. It was also by chance, presumably, that Suzanne Fletcher, speaking on behalf of the Macy Foundation, presented Macy’s Bermuda conference recommendations at the committee’s Jan. 21, 2008, meeting.
Also, while IOM receives private grants ranging from $50,000 to $10 million to write reports and conduct studies — which typically cost as much as $6 million each — IOM has no public reporting structure in place to disclose what money is coming from where. IOM reports mention funding sources, but never amounts, and there’s no federally mandated website that contains such disclosures. (The $75,000 figure was provided to me in my capacity as a reporter).
IS PRIVATE FUNDING NECESSARY?
It’s worth asking whether there’s any empirical evidence that American health care would be better if private, for-profit companies didn’t fund CME?
The debate began in earnest with a very influential 2006 paper in the Journal of the American Medical Association (JAMA). The piece – “Health industry practices that create conflict of interest: A policy proposal for academic medical centers” – was written by Troy Brennan, currently the executive vice president and chief medical officer of CVS-Caremark in Rhode Island, along with a handful of collaborators including the aforementioned David Blumenthal. The paper, wrote Stossel, “broke new ground not only in the severity of its anti-commercial sentiments, but also in its insistence that disclosure of financial conflicts of interest is insufficient to control their adverse effects and that therefore these conflicts must be eliminated.”
Then, last May, the Council on Ethical and Judicial Affairs (CEJA) of the AMA released a subsidiary draft report, arguing that since industry support “has raised concerns that threaten the integrity of medicine’s educational function . . . individual physicians and institutions of medicine . . . must not accept industry funding to support professional educational activities.”
The Accreditation Council for Continuing Medical Education (ACCME) disagrees. In 1992, it established “Standards for Commercial Support” (revised in 2004 so that providers were required to identify and resolve any conflicts of interest). These standards, ACCME chief executive Murray Kopelow asserts, “work well in managing the boundary issues created by the presence of commercial support in accredited continuing medical education.” Indeed, an ACCME-commissioned paper reported in June 2008 that no scientific evidence exists that commercial support of CME creates bias.
Key academics agree. David Williams, chief of pediatric hematology/oncology at Children’s Hospital Boston and a member of the IOM committee, highlights changes that in effect eliminate “marketing bias” in CME through disclosure and clear delineation between marketing and non-marketing information. For instance, at the American Society of Hematology annual meeting, where accredited courses are given, “while pharmaceutical companies can provide money in an unrestricted fashion, they can’t tell [the society], you need to talk about this in this session – you need to talk about this drug or you need to have this speaker come and talk because we want you to.”
This summer promises even more conflict-of-interest theatrics when the IOM ad hoc “Committee on Planning a Continuing Health Care Professional Education Institute” reports. Macy is funding this committee in toto (to the tune of $428,177 thus far) — the Institute being one of the key recommendations of Macy’s Bermuda conference report.
This ad hoc committee includes key Macy-funded participants such as the Association of American Medical Colleges (Macy grants totaling $288,000 and nearly $300,000) and the Institute of Health Policy. (IHS is currently producing the “Campbell Report,” led by Eric Campbell, the goal of which is to develop an alternative funding model for CME, courtesy $150,000 in Macy funding.)
University of Chicago law professor Richard Epstein eloquently sums up the quixotic quest against CME and industry conflicts of interest: “With so much at stake, and so little hard evidence of real abuse under the current conflict of interest regimes, I think that it is little short of incredible that American academic institutions will take it on themselves to block a set of interactions from which both sides can benefit.”
It may be incredible, but it’s happening.
– Mary Claire Kendall served as special assistant to the assistant secretary of health in the U.S. Department of Health and Human Services from 1989 to 1993.