According to tables and charts in Kopelow’s prepared testimony, publishing/education companies that provide CME received $463.4 million in commercial support during 2008, the highest amount. Schools of medicine followed with $225.7 million in commer-cial support for CME.
Kopelow told the committee that the ACCME has taken steps to enhance its requirements concerning independence from commercial interests and has enhanced enforcement of these requirements. These steps include:
• New policy that excludes accreditation to organizations that market, resell, or distribute health care products or services used by or on patients
• Increased scrutiny of providers who receive large amounts of commercial support
• Adoption of a surveillance and monitoring system that involves direct observation of activities in the field by qualified observers
• Providers who are not in compliance with the ACCME’s Standards for Commercial Support would be required to submit an improvement plan within weeks of the finding and demonstrate compliance with the standard within 6 to 12 months
• Ten percent of providers who seek reaccreditation would be placed on probation, up from 1% in previous years
• Development of a Web-based portal for collecting and analyzing up-to-date, comprehensive data from CME providers across the country about their organizations, educational activities, and program financing (this system is currently in the beta testing phase)
• Beginning in August 2009, public disclosure about CME providers, including their accreditation status and whether they accept commercial support on the ACCME’s Web site http://www.accme.org
Taking a contrasting approach to the CME controversy was Stossel, “I see CME as pretty darn effective as it is currently constituted,” he said in response to a question from Kohl. In his prepared testimony, Stossel expressed concern about the effect “of waves of regulatory action” on medical research. “Almost every reason put forward for how conflict of interest supposedly compromises medical research, especially that it promotes research misconduct, is, when subjected to factual analysis, untrue,” he said.
“The expansion of medical product development created opportunities for physicians to participate in clinical trials testing product efficacy and safety. Because of their proximity to daily patient care, the physicians involved were in the best position to advise companies developing the products as they navigated the risks and unknowns inherent in complex biology,” Stossel said. “The same physicians were also well suited to familiarizing practicing physicians with new products as they emerged on the market.”
