THE SAFE HARBOR that CME has enjoyed from government regulation and media criticism is now in jeopardy, said speakers at the Alliance for CME annual conference. Held January 29 to February 1 at the Hyatt Regency Dallas at Reunion, the conference attracted 1138 attendees, with a record 61 exhibit booths. Presenters discussed the latest threats to CME, debated how the community should respond to press attacks, and emphasized the importance of stringent self-regulation.
New Standards Create Contention, Confusion
The latest step in self-regulation, the draft revision of the Standards for Commercial Support, now called Standards to Ensure the Separation of Promotion from Education, created a furor at the meeting. Asserting thatdisclosure of their relationships with industry is not enough to protect CME, the draft stipulates that speakers/teachers should be precluded from serving if their relationships with drug firms constitute a conflict of interest. But how does the define conflict of interest? Attendees peppered Murray Kopelow, MD, chief executive, ACCME, with their questions. What about a physician who owns stock in a company, or whose immediate family members own stock? What about the numerous physicians who serve as consultants or researchers for drug firms?
“The talk in the hallway is that if you interpret these guidelines to the most radical degree, anyone who has received a nickel of commercial support can't serve as faculty,” one attendee told Kopelow. Another said: “You take away our greatest tool. The greatest minds in medicine are virtually all involved in research or have other relationships with drug companies.” Another CME provider added, “A lot of thought leaders are involved in industry. They will take affront.”
Rather than offering specific answers, Kopelow said that the new draft Standards, “are not meant to be insulting. We don't want to react to the doctors' reactions.” Instead, he asked providers and physicians to discuss whether the concepts introduced in the draft would add value and credibility to the CME process. For more coverage of the new standards, see “Mission Impossible,” page 27.
Watch Out for the OIG
But it is the external regulations that should worry the CME community even more, said Michael S. Saxton, national director, clinical education, Pharmacia Corp., Peapack, N.J., referring to the Office of Inspector General's draft compliance program for the pharmaceutical industry. “This one's a sleeper. It is more important than you may realize,” he said. “Murray Kopelow is not going to show up at [a pharma] executive's door one morning flashing a badge — but an inspector from the OIG very well may. [The guidance] will fuel a lot of the compliance efforts that industry is going to have to start doing.”
The OIG draft guidance is extremely important not only to pharma firms, but to the entire CME community, he said, because it makes no distinction between CME and promotional programs. The Alliance for CME, the American Medical Association, and the North American Association of Medical Education and Communication Companies, responded by asking the OIG to clarify the distinction between promotion and education. “No one knows when the guidance will be final, but given the vigorous responses it will probably take awhile,” Saxton said. Nevertheless, he stressed, “We're living with it now, regardless of whether this becomes finalized or not.”
Who's Afraid of The Wall Street Journal?
There has been a recent barrage of negative media coverage of CME, said speakers, including stories in The Wall Street Journal and The New York Times. In response, the Alliance has formed a media relations task force, announced Donald Moore Jr., PhD, director, division of CME, Vanderbilt University School of Medicine, Nashville, Tenn. “Are the allegations in the media correct? It's hard to know — most of them are anecdotal,” he said. “We need to turn down the emotions surrounding this issue so that clearer minds can prevail.” The CME community needs to gather evidence about the relationships between CME providers and the pharmaceutical industry. Moore says, “Some of the issues I'm asking the task force to examine are: Do CME activities that accept commercial support have more bias than activities that don't? Do the current guidelines prevent bias? Are they being implemented effectively? What obligations does the money create on the part of the provider and faculty? What are the responsibilities of the participants in a CME activity? Let us look honestly at the return on investment from the provider and contributor perspectives and ask ourselves if a dependent relationship has developed.”
His comments generated a lively discussion. Several attendees agreed that instead of engaging in media bashing, the CME community needs to take a hard look at industry/CME provider relationships. “I'd like to make a plea to examine the bias — not the bias that occurs in the room where the teaching happens, but bias that happens when you choose what to teach,” said one participant. “There is so much research to show that the increase in diabetes and other chronic diseases is related to lifestyle, but that is not a huge CME effort because nobody makes money off changing patients' lifestyles.”
Added another attendee, “I'm impressed with The Wall Street Journal and The New York Times. They offer a window of opportunity for our industry to be heard. Three months ago I'm not sure you would've gotten The Wall Street Journal or The New York Times to listen. Now you have an active audience.”
The Public's View
In a Wall Street Journal Online/Harris Interactive poll of 4173 people, published January 9 respondents demonstrated their faith in CME.
72 percent of respondents said pharmaceutical companies' support of CME should be allowed.
67 percent trusted doctors to make decisions about which drugs to prescribe.
However, 55 percent said that drug company marketing to physicians was too aggressive.