The U.S. Senate Committee on Finance has extended its probe of pharmaceutical industry educational grants by sending a letter of inquiry to the Accreditation Council for CME. The December 19 letter, available at www.accme.org, explains that the committee is continuing to review marketing practices that influence physicians' prescribing patterns.
As we've reported in previous issues, the committee's inquiry began in June 2005. Concerned that grants may sometimes be used for influence peddling, rather than education, Max Baucus (D-Mont.), now the committee chairman; and Senator Chuck Grassley (R-Iowa), now the ranking Republican, sent a series of letters to drug companies asking them to explain their practice of providing educational grants to organizations and state officials that might be in a position to influence Medicare and Medicaid drug purchasing decisions.
In the letter to the, the senators said they are concerned about pharmaceutical industry marketing that encourages the overuse of products or promotes the use of newer, more expensive drugs that have not been proven superior to less costly alternatives. They are also concerned about marketing practices that increase off-label uses. While acknowledging that off-label discussion is not prohibited in independent CME activities, the letter says that the potential for abuse arises when pharmaceutical companies use CME to deliver promotional messages that they're not allowed to do on their own. Even when CME relates to on-label indications, the senators state that “there is a significant risk of misleading physicians if manufacturers co-opt CME providers to deliver the message for them,” especially as physicians view CME activities as independent.
In a series of 12 questions, which the ACCME is expected to answer by January 22, the senators ask how the ACCME ensures that CME providers comply with the Standards for Commercial Support, how it gathers reports about noncompliance, and how many providers the ACCME has investigated for noncompliance.
“The information requested in the letter will provide important perspective on the issue and needed information on enforcement,” explains an aide to Chairman Baucus. In previous conversations with the SFC,learned that the committee understood that grants given ACCME-accredited organizations were most likely legitimate and used for educational purposes. Asked if this perspective has changed, the aide responded: “The letter should not be seen as a signal that we believe there was wrongdoing; we need to be thorough and gather information from all corners to get a comprehensive picture.”
ACCME's Upbeat View
The ACCME has not been in contact with the committee since an initial conference call in July 2005. While the letter is unexpected, “the ACCME is honored to be asked to provide information to the Senate Finance Committee,” says Murray Kopelow, MD, ACCME chief executive. “ACCME believes in transparency and accountability — so we will share our information, in support of the SFC process. There only can be a positive outcome from this exercise. Either there is affirmation of our process or we identify areas where changes to the ACCME can add value to CME — either way it is useful.” Kopelow adds that the ACCME will make its response public.
The letter asks for data that some experts say may be difficult to provide. For instance, the SFC asked about the number or percentage of industry-funded activities, from 2004 to 2006, that discussed off-label use of a commercial supporter's drug, as well as the number of activities that covered a disease area for which the funding companies produce approved therapies, or had a product in the pipeline. This is not typically information CME organizations would keep records of either, although Kopelow notes that a significant number of providers have retained the requirement that speakers disclose whether their presentations include discussion of off-label uses. This aspect of disclosure was a requirement in the previous Standards for Commercial Support, but is not included in the updated version.
Freedom of Discussion
Discussion of off-label or unapproved uses has historically been an important part of CME, particularly in areas such as pediatrics and oncology, where drugs are often prescribed off label. Harry A. Gallis, MD, president, Alliance for CME, says, “It would severely hamper the educational process ifwere not able to discuss these drugs or therapeutic indications in some venue.”
As for how providers should respond to the scrutiny, Gallis says they should continue doing what they always do to assure content validity, but he acknowledges how difficult it is for CME providers to monitor “every word that comes out of everyone's mouth,” especially at specialty society meetings that attract thousands of attendees and speakers. “We just have to do the best job we can and to be extra vigilant in areas where we've asked for commercial support.”