Senators Max Baucus (D-MT) and Chuck Grassley (R-IA) said ACCME oversight is insufficient to rein in drug company influence on medical education.
In a report stemming from a two-year probe into medical education grants, the Senators, who lead the Senate Finance Committee, charged with Medicare and Medicaid oversight, praised drug companies for taking steps to shelter grant-making from sales and marketing, but suggested that unspecified further regulation is needed.
The report, released Wednesday, said that “it appears the manufacturers have implemented policies meant to rein in [the use of CME for off-label promotion]. The companies have taken steps to separate the grant-making process for educational programs from their marketing efforts. In addition, various industry groups and government agencies have created guidelines for educational grants to reduce the potential for abuse. Drug companies, however, are not mandated to follow the guidelines and a significant gray area continues to exist regarding the use of educational grants to serve marketing purposes.”
Committee researchers based their findings on responses from 23 top pharma companies and the ACCME, along with a review of HHS and PhRMA guidelines regarding CME. The report says that in addition to the danger of companies using CME for off-label marketing, the committee found potential for abuse in the form of kickbacks, veiled advertising and bias in clinical protocols. Moreover, the report repeatedly returns to the assertion that companies would not be writing grants but for a profit motive.
“Continuing medical education has developed into a multi-billion dollar a year industry, much of which is funded by pharmaceutical manufacturers,” said the report. “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.”
In a statement, Baucus said: “This report shows some separation between medical education and marketing efforts, but this process isn’t clean enough. As long as drug companies’ medical education efforts can influence Medicare and Medicaid spending, the Finance Committee has to insist that there be more improvement.”
John Kamp, executive director of the Coalition for Healthcare Communication, said the committee’s demonization of off-label usage was misguided. He noted that independent CME is authorized by the FDA, and that all the specific abuses cited in the report occurred before PhRMA and ACCME enacted their current guidelines.
“I’m a diabetic, and I take eight medications,” said Kamp. “Six of them are off-label, and I don’t want Senator Grassley hanging over my doctor’s shoulder limiting what she prescribes.”