Commercially supported CME took a hit on the Hill before the Senate Special Committee on Aging this summer. But it is far from down for the count.
Things got pretty hot this summer in D.C., even inside the air-conditioned Senate office building where experts on continuing medical education addressed the U.S. Senate Special Committee on Aging. Convened by Chairman Sen. Herb Kohl (D-Wis.) in late July, the hearing aimed to educate members of the committee on the potential for conflicts of interest in commercially supported CME and to provide recommendations for possibly reforming the CME delivery system. Kohl, along with Sen. Chuck Grassley (R-Iowa), is cosponsor of the Physician Payments Sunshine Act (S. 301), which would require pharmaceutical and medical device companies to report all gifts and payments to physicians.
Referring to a report from the Institute of Medicine that industry funding for accredited CME quadrupled from $302 million to $1.2 billion between 1998 and 2006, Kohl said, “Large corporations do not typically spend these sums unless they think they will get something out of it. Are the drug and device industries getting a return on their annual billion-dollar investment in medical education? Do the programs funded by industry stay true to their mission of providing unbiased education and research, or do they instead market the industry's latest products? We are not suggesting that these financial relationships are rife with corruption, but it is clear to us that greater transparency, and perhaps stronger firewalls, should be considered.” Other senators in attendance included Sen. Mel Martinez (R-Fla.) and Sen. Al Franken (D-Minn.).
The hearing was composed of testimony from two panels. The first presented the argument that commercially supported CME is at high risk of injecting bias toward the supporting company's products into CME.
Lewis Morris, general counsel, U.S. Department of Health and Human Services, Office of the Inspector General, explained the HHS/OIG's actions to date, including its “Final Compliance Program Guidance for Pharmaceutical Manufacturers,” released in 2003. Saying that he believes the current CME system is heavily biased toward serving pharma's needs instead of offering fair and balanced education, he nevertheless conceded that the simplest solution — taking commercial support out of the system altogether — isn't practical. He suggested other solutions, many of which pharma companies already are undertaking, such as separating the CME granting function from sales and marketing and disallowing any control over CME content by commercial supporters. He also suggested creating independent CME grant organizations that would be in charge of the entire granting process.
Next, Steven Nissen, MD, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, came out swinging: “Ideally, CME should provide balanced and scientifically based education designed to improve the quality of healthcare. Instead, CME has become an insidious vehicle for the aggressive promotion of drugs and medical devices.” He went on to call into doubt the idea that medical education and communication companies can provide unbiased education. “With a wink and a nod, the communications companies select speakers and topics that they know will please the sponsors,” he said. “In recent years, CME has been increasingly used to conceal payments to physicians that would otherwise be disclosed by transparency rules at hospitals and medical schools. Since the honorarium comes from a third party and is used to support CME, recipients are shielded from disclosure. Essentially, communications companies are used to ‘launder’ money to avoid disclosure.”
He perceived equally disturbing trends in CME offered by medical societies, referencing an editorial published in the Journal of the American Medical Association recently by current and former medical society leaders who called for a zero-industry-funding policy. He was not complimentary about the job the Accreditation Council for CME, which provides oversight for all accredited providers, is doing as industry watchdog, calling the accreditor “largely ineffective,” among other things. “Thehas strict rules governing educational activities but appears uninterested or incapable of enforcing them,” Nissen said.
Among his proposed solutions:
Pass the Physician Sunshine Act requiring full disclosure of all payments from industry to physicians.
On the Defense
Consider legislation that would require all commercial supporters to assume legal responsibility for content. “If false or misleading statements are offered during a funded CME presentation, the funding organization should be held liable by the FDA for misbranding,” he said in his written testimony.
Replace the ACCME with an independent oversight board.
Make commercial support taxable income, instead of a charitable contribution, for nonprofit societies.
Also on the anti-commercial-support side was Eric Campbell, MD, associate professor at Harvard University. He discussed the Institute of Medicine's recent study on conflict of interest in medical research, education, and practice, including its conclusion that the goal should be commercial-support-free CME. Rounding out the panel was Jack Rusley, a fourth-year medical student and the chairman of the Committee on Culture of Medicine at the American Medical Student Association, who talked about the AMSA Scorecard and its methodology for ranking medical schools' policies on transparency in medical education.
Having had to sit quietly while the CME enterprise they believe is already doing a good job of providing fair and balanced education took a beating, the CME defenders then got their turn.
Leading off was Thomas Stossel, MD, director, Translational Medicine Division and Senior Physician, Hematology Division, Brigham and Women's Hospital and leader of the Association of Clinical Researchers and Educators. His main tack appeared to be: Don't throw the baby out with the bath water. Stossel detailed how cooperation between industry and physicians has led the profession from what he called the “terrible and unsafe medicine” practiced 42 years ago when he was an intern to medicine that has been able to increase life expectancy, reduce the need for major surgery, and bring death from cardiovascular disease down by 50 percent.
While he addressed the role of industry funding in everything from research to undergraduate education, he called commercial support of CME the “central battleground concerning eliminating conflict of interest.” He said there's an underlying assumption that education will be improved if commercial funding is eliminated because that would eliminate corruption and bias. There have indisputably been some conflict problems — he listed the specific adverse outcomes ascribed to financial conflicts since 1967, from the Neurontin settlement and guilty pleas for off-label promotion, to the TAP settlement for kickbacks to physicians, to a number of more recent settlements for off-label promotions. But, he said, the harm done by these cases is far outweighed by the good that has come from industry/physician cooperation, and it does not justify “a radical restructuring of financial relationships between the medical products industry, physicians, and medical researchers.
“We had better have pretty good evidence to tamper with a system of innovation and education that has done so much good,” Stossel said. “What passes for evidence is the relentless reiteration of inevitable, sometimes egregious, but vanishingly uncommon adverse events — these events are without reference to the tens of thousands of actions that have led to highly valuable products and much better patient outcomes. The plural of anecdote is never data.”
Next Page: ACCME Pulls No Punches
Sen. Franken, however, wasn't buying his argument. In later questioning, Franken said, “Just because medicine … is a lot better now than when we were kids, that doesn't mean that industry should fund CME. That doesn't follow.”
James Scully, MD, medical director and CEO, American Psychiatric Association, added to Stossel's claim that industry funding has led to advances, saying, “many of the most dramatic improvements in the effective treatment of mental illness have come as a result of newer and better medications. These … would not have been possible without the commitment of the pharmaceutical industry to research and development.” However, he also said that it is important for physicians and CME providers to continue to “re-examine the pros and cons of their relationships with the pharmaceutical industry. Where are the real and perceived conflicts? How can they be eliminated? This is the process that many medical societies are undertaking.” That includes the APA, which recently altered policies and its code of conduct on accepting industry funding for educational programs. For example, the APA board this year voted to phase out industry-supported education programs and industry-supported meals served at APA scientific meetings. The cost, Scully estimated, will be about $1.5 million in lost revenues. “In the long run, however, we believe that the elimination of even the perception of possible undue influence is worth the cost,” he added.
ACCME Pulls No Punches
The final speaker at the special hearing was Murray Kopelow, MD, chief executive of the Accreditation Council for CME, who appeared ready to defend his organization after Nissen's testimony that “Maybe [ACCME doesn't] have resources, maybe they do not have the will. We need ACCME to go away.” Not so fast, said Kopelow.
“Senators, ACCME is the firewall between promotion and education,” he said. “Accredited CME is independent from the influence of commercial interests.” The total revenues of CME providers are about $2 billion, half from learners, half from commercial interests, Kopelow said. However, the relative proportion of CME supported by industry dollars has been in a downward slide since 2003, and in 2008, total commercial support dollars fell by $200 million. He emphasized that while 80 percent of providers accept commercial support, 15 percent of providers receive 80 percent of that support — it's not distributed evenly across the CME enterprise.
Half of the CME in this country is not commercially supported, Kopelow added. “Most CME is happening in small hospitals and county and state medical societies, and it's not commercially supported. It's independent.” When Sen. Franken asked if ACCME wouldn't mind making the distinction between promotion and education clear for the other half that is commercially supported, Kopelow was quick to shoot back: “That line is not blurred in our CME enterprise. Those stories you've heard, that was another time and another place. Our accredited providers clearly draw the distinction and separation between promotion and education.”
One example Kopelow outlined was a new policy that just went into effect that excludes from accreditation any entity that markets, distributes, or resells healthcare products or services. He also discussed recent ACCME proposals that, he said, in many ways resembled some of what had been presented by Morris of the U.S. Department of Health and Human Services, such as creating a new entity independent of ACCME to pool unrestricted educational donations from commercial interests that would be available to accredited providers. When the ACCME floated this idea to its stakeholders earlier this year, most of those who commented deemed it problematic, but Kopelow said it was still on the table. Other ACCME proposals still under consideration include eliminating commercial support altogether from accredited CME, allowing commercial support only under certain conditions where it is in the public need, and not allowing accredited providers to receive any communications from commercial interests related to specific content. (For more on these and the rest of the recent ACCME proposals put out for public comment, go to meetingsnet.com and search keywords “Care to Comment.”
In the meantime, Kopelow said, ACCME has gone on to enhance enforcement of its policies. It continues to offer clarification on its independence criteria and is maintaining its complaints-and-inquiries process for accredited providers whose practices are called into question. It also has developed a new Web-based activity database system to capture information that describes providers' CME activities, including ultimately being able to help monitor any bias toward a particular drug or device.