- © 2008 Canadian Medical Association
An erstwhile government campaign once urged youngsters to “just say no” to street drugs. In an effort to combat the perception that medical education has become largely tainted by the influence of the pharmaceutical and medical devices industries, an Association of American Medical Colleges task force argues that medical schools and teaching hospitals should adopt a similar zero-tolerance approach to industry handouts and simply forbear junkets to exotic resorts, financial payments, sumptuous meals, golf club memberships and even such innocuous goodies as the proverbial donut and coffee.
The association's executive council will decide June 15–17, 2008, whether to formally adopt the task force's recommendations and then commence twisting arms among the nation's 129 medical schools to adopt and implement policies aimed at dissipating what many call the “ubiquitous” presence of industry in most facets of medical education.
Although the association has neither a carrot nor a stick to compel medical colleges to adopt policies reflecting the task force recommendations, Chief Scientific Officer Dr. David Korn says it will use what influence it has to “persuade” schools and hospitals to clean up their local acts. Already, several schools, including Yale, Stanford, Pennsylvania, Vanderbilt, Pittsburgh and the University of California at Davis, have adopted partial policies forbidding faculty or residents from accepting cash, gifts or free lunches from industry. “But they're all different. Some address certain of these areas of concern firmly. Others may address these areas less firmly or even, not mention them at all.”
The widespread public perception that industry payments are influencing therapeutic decisions and that physicians are getting “kickbacks and bribes” to use specific drugs or devices “are really undermining the professionalism of the medical profession,” says Korn, adding that various studies have indicated that “huge amounts of money … in the low billions of dollars, several billions of dollars each year” are now being effectively shelled out by industry for continuing medical education in an effort to influence therapeutic decisions.
“On top of that, there's entirely separate accounting for the freebies, the meals, the trips, the golf clubs, the this, the that. I believe that those direct promotional expenses, to the medical profession, are the largest promotional expense of the industry, in aggregate. It's greater than direct-to-consumer advertising. It's greater than print advertising. The biggest chunk of the marketing budget is direct-to-physician interactions.”
The final report of the Task Force on Industry Funding of Medical Education, headed by former Merck president Roy Vagelos, packed with an array of industry heavyweights and released Apr. 27, 2008, argues that industry handouts have helped to create an insidious “sense of entitlement,” if not an outright reliance on graft within the medical profession, while compromising the core principles of medical professionalism: “autonomy, objectivity, and altruism.”
Industry involvement in medical education should be strictly limited and constantly supervised, says the task force, which was created in 2006 to craft principles by which medical schools and teaching hospitals could “manage industry gifting practices and financial support” for medical education.
According to the task force, prohibitions and policies that academic medical centres should adopt include:
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a ban of gifts from industry to physicians, staff or students, whether cash, textbooks or anatomical models, whether on-site or off-site
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central collection, management and distribution of free pharmaceutical samples, industry funds for continuing medical education programs and scholarship monies. (The task force stopped well short of saying that doctors should pay the full cost of their own continuing education, however, urging only that institutions audit content and quality, including course materials, to ensure compliance with standards of the Accreditation Council for Continuing Medical Education.)
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restricted access to patients and patient care areas on the part of industry representatives
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limitations on industry-run educational sessions about their products. Such sessions should only occur at the invitation of the school or hospital and only in “faculty-supervised structured group settings,” so as to provide students with training about appropriate interactions with industry, using a curriculum that is focused on “evidence-based decision making” and informed by “a scientific understanding of the biasing effects of influence and reciprocity on professional decision-making.”
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limitations on faculty and staff's ability to participate in industry-sponsored programs, including speakers' bureaus. (But the task force stopped short of prohibiting involvement in speakers' bureaus, which generously compensate doctors for promoting the benefits of products. Rather, it urged that schools “strongly discourage” faculty from participating.)
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prohibitions on attending unaccredited industry events and accepting payments or personal gifts for attendance
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a ban on accepting travel funds (except when contractually obligated), lavish meals or other such goodies, whether on-campus or off-site
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outlawing ghostwriting, whether written or oral, “by any party, industry or otherwise.”
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full disclosure of conflicts-of-interest by all staff with purchasing powers
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external spot reviews and audits of all continuing medical education offerings.
Korn says the Association of American Medical Colleges executive council is expected to adopt the task force's recommendations wholesale. “It's the right thing to do. We've allowed patterns of interaction to develop that are really demeaning, when you think about it. I ask people who challenge me whether they would like to be in a Congressional witness chair and tell a Congressman or a Senator that they don't make enough money to buy lunch.”
“These kinds of issues are just steadily eroding the status of the medical profession and I think that's a dangerous ailment to ignore because it leads not only to diminished respect and trust but it also invites governmental interventions. If the profession really wants to continue to assert its privilege of self-governance, then I think it's got to take heed of these things and make changes.”
Ultimately, the goal is to help medical schools and teaching hospitals develop practices and materials that serve to instruct students on appropriate interactions with industry “and to get rid of all of the accoutrements of industry interaction that are only to influence the recipients. There are no other value in them, no other social value in themselves,” Korn adds. “They are mainly a means of creating a sense of obligation, reciprocity so that they [physicians] will look more favorably on that company's product.”
In response to the report, Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said in a statement that companies are now “careful to ensure that their relationships with both healthcare professionals and students are ethical and appropriate.”
“Existing federal law is very clear: pharmaceutical research companies must make sure that information they convey to physicians is accurate and consistent with pharmaceutical product labeling approved by the Food and Drug Administration. These activities are monitored by FDA, which turns any evidence of impropriety over to the Department of Justice for investigation. What's more, the companies and their representatives must not give physicians anything of value to induce or in exchange for prescriptions written by the doctors. Pharmaceutical research companies must comply with strict anti-kickback laws and other criminal and civil provisions enforced by the Justice Department.”
Three of the task force's 30 members did not sign on to all of its recommendations. Jeffrey B. Kindler (Pfizer) and Sidney Taurel (Lilly) agreed with all but the recommendation discouraging participation in industry speakers bureaus. Kevin Sharer (Amgen) said he was “not in a position to endorse the text” of the report but supported its “explicit recommendations.”
Association of Faculties of Medicine of Canada Vice President, Government Relations and External Affairs Irving Gold says that no national guidelines or overarching policy framework exists in Canada comparable to that proposed for the United States. Individual Canadian medical faculties have their own policies and there is widespread variation across the country in terms of attitudes and policies towards industry handouts, Gold says. No effort has been made to compile a compendium of policies existing within Canadian schools, nor an effort made to develop a national policy framework or guidelines.