Physicians and medical institutions should shun gifts, reps, samples and ghostwriting, said the Institute of Medicine’s conflict of interest committee in its full recommendations.
The IOM’s Conflict of Interest in Medical Research, Education and Practice committee said docs shouldn’t see sales reps “except by documented appointment and at the physician’s invitation” and should only accept drug samples “in certain situations for patients who lack financial access to medications.” They should not accept “items of material value” from companies or enter into consulting arrangements unless “based on written contracts for expert services to be paid for at fair market value,” and should not “make educational presentations or publish scientific articles that are controlled by industry or contain substantial portions written by someone who is not identified as an author or who is not properly acknowledged.”
The committee called on Congress to require drug, device and biotech companies and their foundations to publicly report payments to: “physicians and other prescribers, biomedical researchers, healthcare institutions, professional societies, patient advocacy and disease-specific groups, providers of CME and foundations created by any of these entities.” Institutions, the IOM said, should require that employees disclose relationships with medical companies annually.
The committee called for the development of “a new system of funding accredited CME…free of industry influence.” In a public briefing on the report, committee members said their intent was not necessarily to eliminate industry support for CME, but rather to ensure that companies have no say in speaker or topic selection. The committee called for “a consensus development process” to be convened with the aim of proposing such a funding system within the next two years.
The IOM has no policymaking power of its own, but holds tremendous influence with FDA and Congress. The advisory body’s recommendations formed the basis for much of the FDA Amendments Act, enacted in 2007, which gave FDA broad new powers to police advertising and post-market drug safety.
Meanwhile, the Coalition for Healthcare Communication and the Center for Medicine in the Public Interest released a white paper arguing that industry support for CME is transparent, safeguarded against bias and essential to alleviating healthcare disparities and delivering better care to underserved populations.