CME explosion: Who let the dogs out?
The 1990s are regarded as one of the most positive decades for CME. This period saw rapid growth in professional organizations and a proliferation of research and publications. It also saw a spate of new regulation.
Pharmaceutical-sponsored CME increased significantly, and for-profit communications companies finally were getting accredited to provide it. The FDA began faulting some sponsored CME as veiled promotion, and in 1990 Sen. Edward Kennedy led hearings into the influence of marketing in medical education.
As reports swirled that drug companies were pulling their support and academicians were refusing to participate in pharma-backed CME, two med-ed providers writing in MM&M saw the need in January 1991 to quell rumors of a coming “doomsday.”
The nascent AMA Task Force on Industry-Provider Collaboration, addressed the issue with draft guidelines. The task force “sensed with the Kennedy [hearings] and more government [involvement], that we ought to get together and fix this ourselves,” said Dennis Wentz, MD, who was one of its first co-chairs.
The Accreditation Council for CME (ACCME) adopted the 1992 draft and used it as a basis for its Standards for Commercial Support, calling for disclosure of financial relationships and discussion of unapproved uses of drugs or medical devices.
There was even hope that the FDA would be willing to rely on ACCME to police CME. “The thought was, ‘OK, by approaching self-regulation, we're going to call off the dogs,'” said Eric Peterson, VP, Academy for Healthcare Education. But the FDA circulated a proposal in 1992, threatening to bar drug companies from funding CME they knew would include off-label discussion. The task force and the Coalition for Healthcare Communication (CHC) were critical.
Meanwhile, many providers found themselves not knowing what rules with which to comply. The final FDA guidelines of 1997 cleared up some of the doubt. The agency “blew away much of the criticism,” said John Kamp, executive director of the CHC, “because it laid out the factors it would look at.” Among them: strict separation between educational and promotion. The result, said Kamp: “We left the 1990s with quite a bit of clarity on...the rules.”
More regulation means tighter funding
If the 1990s produced clear rules, events of the next decade would compel the industry to take them seriously. In 2003, the Office of Inspector General (OIG) released Compliance Program Guidance for Pharmaceutical Manufacturers, beckoning drug companies to remove CME grant discretion from marketing management.
The guidance came on the heels of TAP Pharmaceuticals' $875 million settlement with the government in 2001. The TAP case involved fraudulent Medicare billing, not CME, yet, “here the OIG was taking action which could seriously impact the bottom line of companies,” said Marty Cearnal, EVP, chief strategy officer, Jobson Medical Information. The OIG, backed by the HHS, had the power to exclude companies from government contracts.
With clear rules, drug companies had upped CME investment as they entered the 21st century. But the OIG guidance—to which Big Pharma responded by centralizing grant management in medical affairs—slowed the growth rate precipitously.
CME's early adventures in new media
Throughout the 1970s and into the 1980s, CME providers began reaching medical audiences through such cutting-edge media as audio and videocassettes, radio and television. Companies such as Merck Sharp & Dohme, Ciba and Smith Kline & French—with the government's OK—backed a national blood pressure education program beamed to docs through open-circuit TV.
In 1986, MM&M ran a story on device firm Dow Corning Wright's “venture into satellite education” via CME video teleconferences. Around this time, the AMA began pilots of optical videodisc systems to present patient management problems to physicians. The man spearheading this effort, Leo L. Leveridge, MD, noted in 1983, “We are on the threshold of a revolution in communication potentially as significant to education as the one which followed the invention of movable type.”
In 1980, MM&M saw a demand for self-directed learning: “If we [ask] physicians in 1985, ‘What is CME,' they will talk less about lectures and conferences and rounds and meetings and more about the learning activities they carry out on their own.” It took some time, but online CME began appearing in the early 1990s. Then in 1995, SCP Communications and Peter Frishauf launched Medscape, a Web site designed for free access to peer-reviewed articles and pictures of use in patient care. It would become one of the most trusted sources of health content to millions. Now, in addition to online enduring materials, video and podcasts, the AMA and AAFP award credit for Web-based point-of-care learning on topics relevant to physicians' clinical practice, and performance improvement efforts. It's safe to say this is a giant leap forward.
Computers in the office? No thanks
A recent survey of physicians by MD Net Guide and Oncology Net Guide found that 50% of docs spend at least eight hours a week online, while 60% of these said that more than two-fifths of their online time was spent on professional activities (70% said they use it for CME).
How things have changed. In 1979, an AMA House of Delegates study asked 3,551 doctors: “Should a physician have access to a computer terminal at the time and place he or she formulates diagnostic and therapeutic plans?” Fully 58% replied “No.”
1968: AMA unveils physicians recognition award.
1972: New Mexico becomes first state to mandate CME for doctors.
1974: The Alliance for CME holds first informal meeting in New York City.
1981: The Accreditation Council for CME holds first meeting.
1990: Sen. Ted Kennedy leads hearings on marketing and CME; AMA forms Task Force on Industry-Provider Collaboration.
1991: PW's Professional Postgraduate Services Group is the first communications company to be accredited.
1992: ACCME Standards for Commercial Support; FDA's Draft Policy Statement on Industry-Supported Scientific and Educational Activities; Washington Legal Foundation's suit against FDA.
1995: Medscape launches Web site, offering free access to 100 peer-reviewed articles.
1997: FDA issues final Guidance for Industry Supported Scientific and Educational Activities.
2003: OIG issues Compliance Program Guidance for Pharmaceutical Manufacturers.
2004: Pfizer agrees to $430 million settlement related to off-label marketing of Neurontin.