At a Senate committee hearing last week, panelists said drug firms should be forced to disclose payments including funding for education, physician travel and food.
The Senate Special Committee on Aging, led by Herb Kohl (D-WI), held the hearing to examine physician links with the pharmaceutical industry. A national gift registry was one of several strategies discussed. Another was stronger adherence to the American Medical Association (AMA) and PhRMA codes, the two voluntary rule sets that govern gifts to the medical community.
“[Sen. Kohl] would like to do a national registry that would just bring public disclosure and transparency to the process,” Ashley Glacel, press officer for the senator told MM&M. “The senator believes that if indeed, as the [AMA] and as PhRMA claim, these gifts are purely for educational purposes, if they are for the benefit of the patients, if they are above-board, then of course those industries should not have any hesitancy to have those out in the public domain.”
Committee members heard that drug companies spend at least $25 billion annually in marketing, much of it to doctors. Academic physicians testified as to the kind of influence this can wield over physicians, particularly in the area of education.
It was the second time this year that the Senate has examined the independence of industry-sponsored CME. In April a Senate Finance Committee report found that the Accreditation Council for CME (ACCME) does not monitor courses or materials for accuracy or evidence of bias. Sponsors fund courses in areas where they have a business interest and so hold sway over which topics are taught. Presenters can discuss off-label uses for drugs, something that Sens. Max Baucus (D-MT) and Charles Grassley (R-IA), the ranking members of the Finance Committee, worry could be used by a company to expand the market for its product.
Moreover, medical schools and medical education companies each depend on commercial support for about three-quarters of their funding. The drug industry accounts for about half of the $2.25 billion in total CME revenue.
Currently Minnesota and Vermont are the only states with mandatory physician gift reporting laws. Data from the state registries cover money paid to doctors for consulting and speaking, mostly for unaccredited educational programs. In April, Eli Lilly launched a national CME grant registry, the first drug firm to do so, and officials hope other companies disclose CME grants.
PhRMA and AMA representatives criticized the idea of expanding gift disclosure laws nationally. In a statement after the hearing, PhRMA said national registries “disarm doctors by inhibiting access to critical scientific information about the benefits and risks of treatment options that help patients win their battle against disease.”
Dr. Robert Sade, chair of AMA’s Council on Ethical and Judicial Affairs, said AMA has not taken a position on mandatory or national disclosure but defended free samples, according to a report in Reuters.
On making the PhRMA and AMA codes law, industry is in favor of self-regulation.
“The Congress, especially the Senate committees that are investigating this…are going out of their way to ignore the value of industry-supported CME,” said John Kamp, executive director, Coalition for Healthcare Communication. “I’m concerned about that, because they seem not to let the facts get in the way of their politics…I hope they come to their senses and stop this war on good CME that is funded by the industry.”