Fair and balanced presentations which rely on evidenced based medicine are principles that for the most part are strictly adhered to in the delivery of continuing medical education (CME) activities across the country. Unfortunately those same rules don’t apply to congressional hearings, as we saw firsthand yesterday at the Senate Aging Committee hearing titled Medical Research and Education Higher Learning or Higher Earning.
There is nothing good that could come out of commercially supported CME – that was the crux of the sentiment of first panel at a recent Senate Aging Committee hearing “. Fortunately there were two panels and he second panel spoke of the advances in medicine and the benefits of CME and that we should not throw out the baby with the bathwater.
By far the most outrageous statement at the hearing or any hearing that I have ever attended goes to Steve Nissen, MD who mused that ending commercial support for CME ($1 billion) would save $90 billion/year or $900 billion/ten years from the healthcare budget thus closing the trillion dollar ten year gap that the law makers have been looking for just by limiting the information physicians receive.
The hearing drew little attention with the national media, and was not covered in any of the national newspapers (Wall Street Journal, New York Times, Washington Post or Boston Globe….)
Details
Committee Chairman Herb Kohl (D-WI) outlined that “Providing ongoing training and access to the latest medical innovations is costly, to say nothing of the resources necessary to produce the research in the first place. Teaching hospitals and medical schools face rising costs as well. From that perspective, industry funding has fulfilled a real need. But as we know, large corporations do not typically spend these sums unless they think they will get something out of it.”
That’s not an indictment of the drug and device industries, it is just how business works. This brings us to the crux of today’s hearing. 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.
Ranking Minority Member Mel Martinez (R-FL) Stated that Today, doctors and patients enjoy access to an abundance of information from numerous sources. Patients rely on doctors to sift through this information and use it to make sound judgments about the benefits and risks of certain medical procedures, drugs, and devices.
While off-label prescribing by doctors is legal and in many instances appropriate, promoting a drug for off-label purposes by the drug-maker is not.
Continuing medical education is essential for disseminating information that helps doctors make decisions about appropriate off-label use of a drug.
Sometimes the line between promotion and education can be blurred. This is why transparency and appropriate, commonsense safeguards, are necessary.
Lewis Morris, Chief Council, Office of Inspector General, Health and Human Services, stated that “Current environment favors the industries needs… almost exclusively covers topics that favor supporters products” he outlined some practices such as directing honorarium that have since.
He threw out that elimination of commercial support would be a simple solution but probably not a practical one.
He suggested several measures that companies can take to mitigate the potential problems with commercial support including:
· Separate grant making function from CME from sales and marketing
· Establish objective criteria for making educational grants to CME providers
· Eliminate any control over speakers or content of the educational activity
For the most part these steps have been adopted by manufactures.
The other major recommendation he suggested is to set up “Independent CME grant organizations” that would review and give out grants independently of the commercial supporter.
Later during questioning he used as an example that the American Academy of Orthopedic Surgeons has set up such an organization but admitted that companies declined their funding requests and the future of the program remains uncertain.
There is something about economics that is continually missing from the discussion. At the end of his presentation he lamented that physicians should pay for their own CME, similar to lawyers, accountants and other professionals. That this would improve the “quality” of the CME, I am not sure how less funds equals greater quality by any measure. The hospitals in Michigan City Indiana would never get a speaker come from out of town and believe you me they need speakers from out of town to educate on important medical issues and breakthroughs.
Morris and the other speakers failed to mention to the senators that the FDA has existing guidance on CME which address many of the issues brought up by the panelist.
Steve Nissen, MD Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, former president of the American College of Cardiology and Prescription Project Advisory Board Member, showed his diversity in being an expert on absolutely everything. Just days ago he was interviewed by CNBC leading the charge on health care reform, today an expert on CME.
Steve prided himself on his JAMA editorial which Senator Kohl lauded as a “research” paper calling for Zero ($0) funding from industry to medical specialty societies. He outlined a fictional world in where “CME has become an insidious vehicle for aggressive promotion of drugs and medical devices” the problem is for the most part he could not be further from the truth.
He complained that “on several occasions I have written the ACCME to complain about inappropriate CME-accredited activities. My letters were never even acknowledged.” In his written comments his proposals include
- Passing the physician payment sunshine act
- Legislation requiring drug and device companies to be held liable if false or misleading claims are made at CME programs (so much for independence)
- Replacing the ACCME with an IOM commission to regulate CME
- For non-profit professional societies eliminating the tax exempt status of CME support
Perhaps the next time company CME departments get grant requests from the Cleveland Clinic, they are sent back with Dr. Nissen’s comments attached for clarification.
Eric Campbell, PhD Director of Research at the Institute of Health Policy at Harvard (who’s carrier has been doing anti-industry studies) Discussed the Institute of Medicine Report on Conflicts of Interest in Medical Education, Research and Practice. He discussed the frequency of industry relationships (considers all relationships ubiquitous) he sees risk of undue influence everywhere. He stated the IOM report called for disclosure of all types of payments. Outlined that system is far too reliant on industry funding, admitted that though they lacked tools to measure the committee saw significant opportunity for bias (i.e. we know it is there) goal of IOM is funding system free of all influences of industry. He called for stronger enforcement measures (ie government intervention).
The final panelist was Jack Russly a medical school student from Brown University and national leader of American Medical Students Association (who told Tom Stossel he signed up a as member of the Association of Clinical Researchers and Educators ACRE) spoke about the Pharm Free Score Card which is now supported by the Prescription Project which rates universities on their conflict of interest policies. For the most part young Jack was clueless.
During the discussion it was clear that the two Senators Martinez (R-FL) and Frankel (D-MN) who participated in the hearing with Senator Kohl, were completely unfamiliar with current continuing medical education practices and were in shock as would anyone who had no understanding of CME after they had they heard the first group of speakers with no contextual framework. The Kohl staff by the selection of the first group of speakers did a great job in putting CME practices in the worst possible light essentially blaming CME for all the problems in the healthcare system.
When the first group was asked by Senator Kohl if there was anything good about commercial support of CME the first group unanimously stated there was nothing good to come from commercial support of CME.
The second panel was designed to bring some balance to the hearing by the time they got to that panel the room had cleared out significantly.
Thomas Stossel, MD, who is the American Cancer Society Professor of Medicine at Harvard Medical School and in the leadership of the Association of Clinical Researchers and Educators (ACRE), identified significant healthcare advancements made possible through physician-industry collaboration. Industry support of independent medical education and research has helped increase life expectancy, lessens the need for major surgery and cardiovascular disease deaths have fallen by 50% over the past 30 years, and cancer deaths are at an all time low.” Stossel said.
While some individuals are calling for the elimination of industry support for research and education, due to alleged conflict of interest, Stossel urged Congress to rely on facts instead of accusations and anecdotes. Past isolated examples of unethical behavior should not be used to taint an improved system that enables productive, ethical collaboration for the advancement of research and education which ultimately improves patient health.
“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.”
Stossel addressed the fact that medical advancements and improved patient health requires increases in research and independent medical education funding. Without industry funding for education and research, physicians will have an even more difficult time keeping up with the new science and information related to novel drugs and improved practices. Despite significant changes and regulatory improvements in the continuing medical education (CME) arena, unfounded accusations about conflicts of interest have pushed pharmaceutical and medical device manufacturers to reduce education funding by 20% in the past year alone. If these trends continue, patient benefit will diminish along with other positive outcomes stemming from physician-industry collaboration.
Unfortunately the information he was sent by the committee he was asked to address issues in research, education in both medical school training and continuing medical education, so his talk was broader than the other speakers.
James Scully, Jr. MD Medical Director and CEO of the American Psychiatric Association described some of the steps they have taken to manage conflicts of interest and respond to congressional inquiries. A telling part of his presentation was the revelation that the APA has more attorneys on staff than physicians. He also stated that the changes in their policies are costing the association $1.5 million/year. He thinks that the new focus on real and perceived conflicts of interest is a good thing….
Murray Kopelow, MD , MS the Chief Executive Officer of the Accreditation Council for Continuing Medical Education (ACCME) outlined that CME has valid content
He strongly stated that CME is currently independent of influence of commercial support.
The relative portion of CME supported by commercial entities continued a decline that began in 2003. In real portions commercial support dropped by $200 million in 2008.
15% of provider receive 80% of the commercial support, the policy that excludes any entity that produces programs that promote products.
He discussed the proposals that are on the table at the ACCME including:
- Complete elimination of commercial support
- Allowing commercial support when:
- Educational needs are indentified and verified by an organization that is free of commercial support
- CME addresses a gap in professional practice corroborated by bona fide performance measures
- CME content is from a curriculum specified by a bone fide organization
- CME is verified free of commercial bias
- Accredited providers must not receive communication from commercial interest related to specific content that would be preferred.
- Persons paid to create or present promotional materials on behalf of commercial interest cannot control the content of accredited CME
Overall the ACCME has instituted policies for monitoring and surveillance of activities to look for any CME violations. He explained that as many as 10% of the accreditation decisions result in probation.
He explained the ACCME’s strict enforcement of accreditation policies and the changes that the ACCME has made in the areas of transparency and enforcement.
Summary
At the end of the hearing the Senators were much more open to commercial support than after the first panel. Senator Martinez brought up that we should not stop free enterprise from taking place.
We have to consider that the issue of commercial support of CME is just a pawn in a wide chess game going on between drug and device manufactures and politicians. We can’t take this personally; there is no responsibility on the increased cost of healthcare assigned to the government, hospitals or insurance companies yesterday the entire blame was laid on the feet of CME.
One positive note the committee blew up and printed a large poster of the Coalition for Healthcare Communications Ad that medical communications including CME constitutes free speech and in America, we don’t censor free speech….
Commercial support of CME took a beating, but in the end with the advances in medicine and the improvement in patient care that CME contributes to, it will live to see another day.
Webcast
Statements
- Senator Herb Kohl (D-WI), Chairman
- Senator Mel Martinez (R-FL), Ranking Member
Witness Testimony
Lewis Morris,, Chief Counsel to the Inspector Geneal, US Department of Health and Human Services, Washington, DC
Steven Nissen, MD, Chairman, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH
Eric Campbell, Ph.D., Associate Professor, Director of Research, Institute for Health Policy, Massachusetts General Hospital, Harvard Medical School, Boston, MA
Jack Rusley, Chairman, Culture of Medicine Action Committee, American Medical Student Association; Student, Brown University, Alpert School of Medicine, Providence, RI
Thomas Stossel, MD, Translation Medicine Division and Senior Physician, Hematology Division, Brigham & Women's Hospital, Harvard Medical School, Boston, MA
James Scully, MD, Medical Director and CEO, American Psychiatric Association, Arlington, VA
Murray Kopelow, MD, MS, FRCPC, Chief Executive, Accreditation Council for Continuing Medical Education, Chicago, IL
Written Testimony
Council for Medical Specialty Societies
Dr. Danny Carlat, Tufts School of Medicine