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Senate report suggests drug makers have too much influence on CME content.
Legislative scrutiny on drug marketing--which has only intensified as Congress debates the reauthorization of the Prescription Drug User Fee Act--has zeroed in on medical education.
A recent report from the Senate Committee on Finance concludes that while drug makers have taken steps to separate their education and marketing efforts, companies still exert "too much influence" over the content of industry-funded continuing medical education (CME). And one drug maker, Eli Lilly, has already announced that it will make its process for awarding educational grants more transparent.
The Senate report found that over the past two years, 24 percent of CME providers did not comply with policies designed to limit pharma's influence on physician education. In addition, there is little incentive to follow the rules--it can take up to nine years for non-compliant programs to lose their standing with the Accreditation Council for Continuing Medical Education (ACCME).
Yet the report also commended pharma on recent moves to raise a wall between its educational and promotional efforts. While drug makers once put marketing departments in charge of awarding CME grants, medical-affairs teams now hold those reins. "The committee staff found some promising trends in pharmaceutical manufacturers' use of educational grants, but risks remain for fraud and abuse in several areas," the report stated.
Starting in June 2005, senators Max Baucus (D-MT) and Charles Grassley (R-IA) asked the 23 largest pharma firms to provide information about their educational grants programs. It also reviewed information from ACCME, peer-reviewed medical journals, and the mainstream media.
"The documents provided by the pharmaceutical companies do not reveal an explicit agreement that the CME program will favorably discuss a company product or an off-label use of a company product," the report noted. "However, it is possible that both parties reasonably expect that to be the result."
That unspoken quid pro quo, the report continues, likely hinges on the sheer amount of money that drug makers pour into CME grants. In 2005, the largest companies doled out $1.12 billion, or 75 percent of their total spending on educational grants, on ACCME-accredited programs--courses that physicians must take each year in order to stay licensed. Oncology, cardiology, and neurology/psychiatry programs nabbed the biggest industry bucks.
"It seems unlikely that this sophisticated industry would spend such large sums on an enterprise but for the expectation that the expenditures will be recouped by increased sales," the report stated. It goes on to suggest that FDA might have a role in regulating CME, just as it monitors direct-to-consumer advertising.
In response to the April 25 report, Lilly last week became the first drug maker to begin posting all of its educational grants online, at Web site www.lillygrantoffice.com. The grants fund educational programs developed by medical societies, academic centers, patient groups, and nonprofit organizations.
Legislators aren't the only ones skeptical about pharma grants. An online poll from Envision Solutions, a marketing-communications consulting firm, found that 43 percent of consumers believe that drug makers fund educational programs in order to increase sales.