Last week the AMA CEJA staff developed an a Appendix with clarifying questions to address questions on CEJA report that will be given to the members of the House of Delegates upon registration for the AMA meeting. It opened with the following note:
As you're aware, the report on industry support for professional education in medicine by the Council on Ethical and Judicial Affairs will be submitted to the Reference Committee on Amendments to Constitution and Bylaws on Sunday afternoon, June 15th. Over the past several weeks the Council and CEJA staff have received questions from many quarters seeking clarification of this report. These questions aren't meant to be exhaustive, of course, but it is the Council's hope that you will find them helpful as the profession moves forward in deliberations on this very important topic.“
The clarifying questions demonstrate:
A) CEJA’s agenda is not just to eliminate commercial support of certified CME, but to limit physician relationships with industry in research, data use, medical student training, drug sampling and all marketing and promotion.
B) CEJA’s clear agenda to limit industry support of clinical, scientific and other educational activities for practicing physicians.
The two points in the appendix addressing CME are clear for the CEJA Q & A:
1. Question 9. Why aren’t the new ACCME Standards for Commercial Supportsm sufficient to deal with the potential problems?
CEJA Anaswer: The new ACCME Standards for Commercial Supportsm take the approach of disclosing and mitigating conflict of interest. But even such stringent efforts to build “firewalls” and manage conflicts of interest aren’t sufficient to guarantee professional autonomy in designing and carrying out educational activities.
This, the first time CEJA acknowledges the ACCME, is the equivalent of saying that the ACCME standards to ensure fair balance and elimination of bias in certified CME programs has no value. The real objective appears to be the elimination of industry contact with doctors because such contact is inherently evil, has no value and must end to protect the ethics of the medical community.
According to CEJA -- disclosure is not good enough:
Disclosure passes the burden of managing conflict on to learners, who usually are not in a position to distinguish “objective” from “biased” information. Further, disclosure can create a false sense of security about the objectivity of information—presenters may feel they have adequately managed the conflict and need no longer strive for objectivity, while learners may perceive presenters as especially honest and become less skeptical about what is being presented.
This suggests that doctors are not well trained, intelligent and reasonable people, who can make professional and ethical decisions for themselves. Indeed, according to this logic, doctors are easily “duped” if a speaker has any ties to industry, despite the doctor’s education and expertise in the field.
Since the CEJA report recognizes correctly that bias is a function the human condition, and that all carry bias, the Report and Q & A raise a clear question why CEJA focuses only on possible industry bias – and seeks to eliminate it by banning it – but fails to address academic and other non-industry sourses of bias. Why is it wrong for one group to support CME and not another? In the marketplace for ideas, don’t we want decision makers to be exposed to as many competing ideas as possible so that those ideas stand on merit. That is the idea behind the cherished protections of academic freedom and the First Amendment. If the government cannot control the marketplace of ideas, why should the AMA institute a system that seeks to have academic or other elite medical institutions do so?
Moreover, even when commercial funders have no input into identifying topics, selecting speakers, or developing educational content they can still have considerable influence on CME programs and activities. Companies make educational grants consistent with their overall business strategies and therapeutic areas of interest—commercially supported CME programs tend to address a narrower range of topics, focusing on clinical conditions that pertain to their product(s).
Why is it wrong for industry to support “grants consistent with their overall business strategies and therapeutic interests”? Do the CEJA report writers realistically expect a foundation or government agency focused on healthcare like HHS or the Gates Foundation to support courses on high speed trains or archeology?
CEJA presents simplistic arguments to complex subjects without using the scientific and logical rigor demanded of such significant topics. This is not in-line with the type of scholarship one would expect in asking for a wholesale change of the existing system of medical education.
1. If we can’t accept commercial funding, how will we financially support professional educational activities in medicine?
This is a good question. Where will the money come from?
Some organizations and institutions have already begun developing independent professional education, offering models for the profession. The Society for General Internal Medicine, for example, accepts virtually no commercial support for its educational activities and no commercial advertising in its journal.
Yes this may be true, but SGIM is an association of generalists and provides very little CME for their members outside of their annual meeting. Their meeting cover limited topics and the cost for membership and journals are higher than the AMA’s own Journal, JAMA.
Perhaps as first step, consistent with the serious concerns about industry marketing in the CEJA proposal, AMA should consider forgoing the advertising income in JAMA. If as CEJA suggests, “firewalls” are of no value, is the same true for the “firewall” between editorial and advertising matter in JAMA? Of course not, but that is the rational of the current CEJA report.
A number of academic medical centers, including Boston University, the University of Michigan Health System, Yale University School of Medicine, and Stanford University, have moved to significantly curtail, and in some cases eliminate, industry access to trainees and faculty.
This is partially true, but a new and as yet not fully tested formula for improving patient care. Meanwhile, all these institutions have huge endowments, which allow them the flexibility to pay substantially more for faculty and provide for patient care. Meanwhile, there is not clearly agreed upon research basis for these moves by some academic centers. To suggest that all medical facilities, and all doctors follow the example of very well endowed medical centers, fails to recognize the economic reality faces by others.
Medicine might also consider following the example of non-medical educational institutions, such as MIT, that have made their entire curriculum available free over the Internet (http://web.mit.edu/mitpep/pi/ceus.html).
It may be true that MIT is offering its curriculum for free, but if the public wants to take these courses for credit, the student will need to pay for it.… And, like the institutions noted above, MIT has a huge endowment, not often encountered in the medical centers that serve the majority of America’s patients.
There are already many independent CME offerings available at low or no cost to participants—for example, PharmedOut offers a list of non-industry-sponsored CME programs, including U.S. government sites
Their primary source of free CME, pharmedout.org. The website lists about 30 courses covering scientifically and clinically relevant topics, including What's Hype? What's Right? Assessing New Information from Pharm Reps to the Latest Journals, An Introduction to the Improved FDA Prescription Drug Labeling, Sex and Gender, National Center for Complementary and Alternative Medicine (NCCAM). It also includes(six course on topics such as: Herbs and Other Dietary Supplements, Mind-Body Medicine, Acupuncture: An Evidence-Based Assessment, Manipulative and Body-Based Therapies: Chiropractic and Spinal Manipulation, CAM and Aging, Integrative Medicine, Health and Spirituality. Regardless of their value, these would not be constitute a full sevice offering by most primary care physicians let alone specialists.
In addition, some specialty-specific sites offer CME at little or no cost (e.g., in psychiatry, Clearview CME Institute, http://www.thecarlatreport.com/index.asp? page=wp315200717754).
Daniel Carlat, MD is a self designated leader to eliminate industry funding for CME. Does CEJA ignore the commercial interest of Dr. Carlat, his subscription newsletter business that stands to benefit from CEJA’s proposed action? Apparently, some sources of commercial bias can be managed, even without CEJA including a disclosure. Others, with significant management procedures in place, must be banned.
It’s also important to remember that most (in many cases, all) of the costs of participating in CME programs are tax deductible in the U.S as business expenses.
The AMA members of the House of Delegates may look at the proposal differently. They may consider that CEJA proposal significant new “tax” on all AMA members, because it would force many of them to pay for the CME currently, supported through grants.
In sum, the CEJA staff does not offer realistic alternative to the existing system of allowing the industry to support independent certified CME. Indeed, there is no reasonable assessment of the cost to doctors and to patients. This CEJA summary just gives the House of Delegates additional reasons not to support the CEJA recommendations.
We strongly encourage the House of Delegates to vote against this proposal.
To download a printable copy for distribution: Download ama_ceja_appendix_discussion_6908.pdf
Danny,
You have to have a better argument than that, if you get bulk subscriptions, would that effect you. Our programs are peer reviewed to help elimnate bias, not sure you can do better than that no matter where you get the money from. Your arguments would have journals stop all advertising, and no one pay for the system as you say there is no Free Lunch -- Someone has to pay.
Posted by: Tom Sullivan | June 09, 2008 at 07:09 PM
Tom, it's all about incentives, and how likely the incentives are to distort medical education. If you're paid by drug companies, you have an incentive to distort the material in favor of the sponsor's drug. If you're paid directly by the learners, you have an incentive to provide valuable, educational, practical information. Both are commercial enterprises, but there are two very different incentives, and therefore different outcomes.
Posted by: Daniel Carlat | June 09, 2008 at 04:35 PM