“Receiving a letter from the United States Senate Finance Committee is a frightening experience,” said a CME professional from a major pharmaceutical company during a hot-topics session at the Alliance for CME annual conference. From the comments other attendees made, it appears that many CME professionals, whether on the industry or provider side, agree that the government's focus on funding is definitely something to worry about.
Speakers explained that the Senate Committee on Finance had extended its probe into pharmaceutical companies' educational grants. On January 9, the committee sent a follow-up letter to 23 pharmaceutical companies asking for further information about the role of sales and marketing personnel in awarding grants, and whether funding had supported the development or dissemination of treatment guidelines.
As we reported in our July/August and September/October issues, in June 2005, Sens. Chuck Grassley (R-Iowa) and Max Baucus (D-Montana) sent 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. The senators are concerned that grants may sometimes be used for influence peddling, rather than education. Grassley is the chairman and Baucus is the ranking Democrat of the Senate Finance Committee, which oversees Medicare and Medicaid spending.
After reviewing the information received in response to the first letter, the committee found that while many manufacturers have modified their grant policies in response to guidelines issued by the Office of Inspector General and Pharmaceutical Research and Manufacturers of America, sales and/or marketing personnel still have a role in handling grant requests at many companies. Therefore, the potential for abuse remains, the January 9 letter said.
In the January 9 letter, the senators also expressed concern that professional and patient-advocacy organizations that develop treatment or practice guidelines “may come to rely on such funding to the extent that it may compromise their independence.”
The Senate committee asked companies if grant payments made in fiscal years 2003 and 2004 to medical organizations and patient advocacy groups supported the development and/or dissemination of journal articles and other published material, practice or treatment guidelines, or implementation of medication algorithms. If so, the committee requested details such as the journal title and date of publication.
Providing this information may prove problematic for drug companies, said one pharma participant during the hot-topics session. “All of us want to cooperate to the fullest extent of the law; however, some of the [information] they asked for, we simply don't receive or collect, nor do we have the subpoena power to get [it], which adds another level of anxiety for all of us.” She asked CME providers to provide industry supporters with the publication details the committee requested.
Another attendee expressed concern that the committee had apparently examined the tax returns of at least four professional and patient advocacy organizations; these returns were referenced in the January 9 letter sent to Johnson & Johnson. Should medical societies be prepared to turn over tax returns and other records concerning grants? The question is “too premature and hypothetical to answer at this point,” said Carol Guthrie, a Democratic aide with the Senate Finance Committee, in an interview withafter the conference.
Since many companies asked for an extension of the February 6 deadline to respond to the second letter, the committee was still waiting to receive responses at press time. As for the future, “it's uncertain whether there will be a Senate hearing this year. There are a number of issues in the queue,” Guthrie said. Meanwhile, if the committee finds evidence of improper activities, it will refer the information to the proper authority, such as the OIG.
In earlier discussions with the Senate Finance Committee, Medical Meetings had learned that the committee would tend to look on industry-funded certified CME activities as likely to be legitimate. There has been no shift in that perspective, said Guthrie, explaining, “We are looking at all grants to be thorough and fair.”
Nevertheless, CME leaders need to take a stand, said a pharma attendee during the hot-topics session. Observing that the senators are concerned that educational grants might influence off-label prescriptions of drugs and thus drive up healthcare costs, she said: “What is wrong with supporting educational grants that promote good science based upon evidence and robust clinical trials?” She suggested that CME leaders visit the senators to give them an accurate picture of CME.
Speaker Bruce Bellande, PhD, executive director, ACME, responded that he has had candid discussions with a committee staffer. While the Alliance has not made plans to visit Washington, it did send a letter to the committee after the conference, offering to clarify issues related to certified CME.