After it was recently announced that the American Heart Association (AHA) will not allow employees of medical manufacturers to contribute science in their medical education presentations this year during its annual Scientific Sessions, the Milwaukee Journal Sentinel wasted no time running an editorial calling this approach a “good idea.”
What the Sentinel thinks is a good idea—calling for an end of commercial support of continuing medical education (CME) and not allowing doctors who do anything with industry to participate—will really only hurt patients because physicians will be less trained to deal with new and complex diseases and the innovations and breakthroughs that can help treat them.
While critics of industry funded CME believe that “the ubiquitous presence of the pharmaceutical industry in doctor education in recent years has tainted medical education,” these opponents clearly ignore the progress in medicine and health outcomes collaboration with industry has created. With longer life spans, better survival rates for cancer and heart disease, vaccinations, treatments for diabetes and other chronic diseases, and various life altering medical devices, the presence of industry in CME in recent years represents the true spirit of American progress and leadership in the world of health care.
Often, the same critics use the same faulty logic in attacking industry funded CME by claiming that “drug company participation is often part of a company's marketing plan.” While six years ago that may have been the case, ACCME regulations prevent any content control from sponsors of CME events, and companies have clearly separated education and marketing budgets.
Further, all CME programs funded by industry and presenters themselves clearly disclose during presentations the nature of this funding so that doctors and health care providers are able to evaluate the level, if any, of bias or “marketing” at a specific program.
The editorial also claims that industry funded CME “presentations are designed to gin up interest in a new drug or to promote new uses for an old one, and that such presentations may lead to overprescribing and quite possibly increases the cost of health care.” First, new drugs are designed to benefit patients and diseases that need treatment, and are used to address gaps in care where other forms of care are inadequate. In such cases, new drugs can lead to better outcomes for patients of have seen less success with other treatments. Additionally, there is no need to “gin up interest” for diseases such as cancer, diabetes, obesity or heart disease, when tens of thousands of people die from them each year. Consequently, hardly anyone who is affected by these diseases or has a loved one suffering would argue that new ways to teach doctors how to treat these problems are a bad idea.
CME and Discussions
Second, CME presentations regarding new uses for old drugs—commonly known as off-label uses—are protected under the First Amendment by a case decided over a decade ago in federal court. (WLF vs. FDA, 2000)
Despite their illogical claims, the Sentinel still believes that industry representatives should only be allowed to make presentations outside of CME programs and that the pharmaceutical industry should not be involved in either funding or presenting medical education. Such an approach would surely deprive “doctors of worthwhile science emanating from the private sector.”
Acknowledging this viewpoint, Endocrine Society President Robert A. Vigersky, MD, who was quoted by the Sentinel in the original article covering the new ACCME rule and AHA’s policy, sent a letter to the authors clarifying that his comments were taken out of context. Specifically, Dr. Vigersky wrote the Sentinel that his statement was a “misrepresentation of The Endocrine Society’s approach to industry participation in CME programs at scientific meetings.” He asserted that
“Industry scientists are welcome to participate in Society CME activities if they are discussing the scientific basis of disease. The Endocrine Society appreciates that appropriate relationships with industry offer important benefits for the field and for the public it serves. These relationships foster collaboration and innovation among the scientific and medical community.”
Unfortunately, other organizations have also been forced into the same position as the AHA, such as the American Society for Clinical Pharmacology and Therapeutics (ASCPT), which has half of its members from industry.
Accordingly, this kind of approach that suggests all doctors and scientists are equal, except some are more equal than others, is problematic (think Animal Farm). It leaves those patients with intractable illness in a bit of a pickle as the moralist-physician practices his art unobserved while the scientist-physician knocks at the door.
Part of the problem is interpretation of the policy, the ACCME website states:
Can employees of commercial interests serve as planners or speakers in our accredited CME activities?
If the content of CME that the employee of the commercial interest controls relates to the business lines and products of its employer – NO.
If the content of CME that the employee of the commercial interest controls DOES NOT relate to the business lines and products of its employer – YES.
The problem with a strict interpretation of this results in a strict policy of restricting presentation of scientific findings conducted by a company using their labs. Company research created by employees consists mostly pre-clinical through phase I research. It is not necessarily in the interest of the progress of medicine to exclude them from presenting their research findings in medical meetings.
9) Can we offer accredited CME activities on research that was controlled in some way by a commercial interest, either through funding, collaboration, or involvement of the commercial interests’ staff in the research itself?
Yes, as long as the CME activity complies with the ACCME’s Accreditation Criteria, including the ACCME® Standards for Commercial SupportSM. It is understood and accepted that industry conducts its own research and that industry partners, as funder or collaborator, in research projects. An important step in the translation of discovery to practice is the dissemination of the results of this research. There are several layers of internal and external controls already in place to manage the conduct of research (e.g., Institutional Review Boards, Government agencies) and the dissemination of results (e.g., editors, peer review, international standards.) The ACCME does not intend to interfere with these carefully managed phases.
However, when an organization chooses to base its CME content on research the organization assumes responsibilities related to CME, including compliance with the ACCME® Standards for Commercial SupportSM. The CME content (not the research that has already taken place or is taking place) cannot be controlled by a commercial interest. As an example, industry employees cannot deliver oral presentations and cannot author enduring materials that are accredited CME if the CME content relates to business lines or products of their employer.
Though this is a straight forward exclusion of industry scientists, it is unclear if the original intention of the ACCME was to exclude industry scientists from presenting at scientific CME activities.
If this was the case the initial presentations on ACE Inhibition, statins, anti retroviral or new antibiotics would have been not allowed under this ruling as industry scientists did much of the initial work on these drugs.
This separation is also already seen in many CME forums that do not allow industry employees (mostly exhibitors) to quietly sit in on the proceedings of the meeting as part of the audience. If such a trend continues, will physicians and scientists who work with industry not be allowed to sit in at CME events? Such a result could create a world of CME in hermetic catacombs, or at least behind the locked doors of the Hilton ballroom, which would be a curious approach to better patient care.
Another example of problems that could come from a strict ban on industry involvement in CME is the ability for device and drug companies who self insure and employ full time family practice physicians. Presently, these physician employees of industry are permitted to hold a medical license and provide direct care to patients. But by ACCME's policy, these clinic doctors cannot submit important case reports or patient series to their professional societies. This is a grave concern since the clinic sees thousands of patients a year and their doctors treat an enormous variety of ailments, some very unusual. That others cannot learn from them in customary forums is reckless and disgraceful.
The environment a rule like this creates can beg the question of whom to censor next? Will former employees, relatives/spouses of employees, applicants/candidates for industry jobs, known associates, industry sympathizers, recipients of Lilly foundation grants, mutual fund shareholders, employees of non-medically related companies, medical corporation volunteers, physician employees of for-profit hospitals, physicians with industry patients be banned?
So far the conflict of interest debate has been decidedly one sided, focusing exclusively on financial conflicts of interests with industry at the exclusion of other potential biases.
Some considerations are that bias from insurance companies conducting prescription switch programs at the point of care, physicians working with trial attorneys to discredit industry, hospital based physicians promoting their own system and referrals, and the one upmanship by proponents of alternative medicine that results from exaggeration of trial results and claims not supported by the evidence.
What such a rule demonstrates is that ACCME has not been specific about this and appears to have overlooked some potentially biased faculty whose presentations/contributions might lead to increased/or decreased and irresponsible consumption of herbs, drugs, devices, computers, imaging…..
For those who assert that the goal of CME “should be thoroughness and fairness,” they violate their own principles by attempting to eliminate truthful information such as the data and research industry funding provides. Moreover, many CME providers use independent analysis to review CME programs funded by industry to ensure that content is unbiased and of the highest quality to address gaps in care, and to remain free of marketing. While we agree that doctors certainly need unbiased information about treatments, excluding one source of information because some may perceive a potential bias does not accomplish that goal.
In fact, "to discount legitimate and high-quality science and not offer it as part of continuing education because it originates from industry is a scary proposition with the potential of disastrous long-term consequences.” As a physician friend noted, “to imply that scientist’s present biased material merely because they are employed by industry is inaccurate and ill thought out."
That is because “appropriate relationships with industry offer important benefits for the field and for the public it serves, and because these relationships foster collaboration and innovation among the scientific and medical community.”
Clearly then, at a time when doctors will need to be more educated to treat a growingly sick and elderly population, and when 30 million more people—some of which have never had health care—are being added to our health care system, America should be demanding more education and training of our doctors to address these issues, not. cutting out a critical source of resources to help educate our medical professionals.