Whether commercially funded education can be unbiased
Whether continuing medical education paid for by pharmaceutical and device companies can be free of bias toward their products is a long-running argument. Its parties disagree about whether the rules separating funders from content work, whether education could be sustained without the money, and what kind of evidence could settle the question. The studies that exist measure what learners perceived.
The two questions in dispute
The influence of advertising on medical writing was already controversial in 1900, when a physician wrote that with so many journals few could live on their subscription receipts, so pharmaceutical firms were appealed to for advertisements, and that greed for advertising patronage led the editor only too often to prostitute his pen or his pages to the advertiser, filling journals with articles and editorials containing covert advertisements of this and that remedy. More than a century later, the merits of the relationship between commercial support and those who develop and run continuing medical education (CME) were still debated.
At the core of the debate in 2012 were two issues: whether commercially funded CME allows bias into CME content, and whether without commercial support the development and availability of CME would be so impeded that the quality and quantity of continuing education available to health professionals would be diminished and the nation's health care eroded. These issues had spurred government investigations; voluntary regulatory and guideline changes by government agencies, trade associations and accrediting bodies; and research into the impact of commercial support on CME and its participants.
Physicians need fresh information, updates, clarifications and corrections taught in an environment free from commercial bias. By 2019 industry had increasingly sought to influence programme content and the choice of speakers, and leaders in medicine and in government were asking about the effectiveness of CME, the influence of commercial support, and the value of CME credit and accreditation in assuring that courses offer valid content free of commercial bias.
The provider companies' position on risk
In May 2007 the North American Association of Medical Education and Communication Companies (NAAMECC), a nonprofit association promoting best practices in CME, convened a panel of experts and published the discussion as a monograph, Industry Funding of CME Under Attack: Enhancing Compliance and Mitigating Risk. Its summarised conclusions were:
- The type of provider, whether a medical education and communication company, a medical school or a hospital, has little bearing on risk.
- There is no difference in risk between solicited and unsolicited grants for activities related to disease states, and firewall requirements should be established for all providers to ensure independence.
- Disseminating off-label information has important public health consequences, and enforcement actions should not be undertaken unless government medical or scientific personnel have first evaluated their public health implications.
- The proposal by the Accreditation Council for Continuing Medical Education to treat medical education and communication companies as commercial interests is anticompetitive and an extreme overreaction.
- Ongoing training is needed for providers and supporters to create a culture of compliance.
Calls to end commercial support, and the response
In November 2007 an ad hoc group convened by the Josiah Macy, Jr. Foundation, a New York philanthropy that supports the improvement of medical education, recommended that accredited organisations providing continuing education should not accept any commercial support from pharmaceutical or medical device companies, whether directly or indirectly through subsidiary agencies. The group, physicians and nurses who were leaders in medical education and publishing, also called for radical changes in continuing education methods and accreditation.
In 2010 the University of Michigan Medical School announced that it would ban industry funding of its CME programmes from 1 January 2011, and it was believed to be the first US medical school to adopt such a policy. At the other end of the debate, more than sixty haematologist-oncologists responded to an editorial in Mayo Clinic Proceedings with concern about the increasing scrutiny and regulation of their relationship, as clinical educators and investigators, with industry and with CME providers. They wrote that what had been missing from the dialogue was a concerted response from those who had worked with industry and CME providers presenting the opinion that these interactions are of real value, and that evolving institutional and national trends might seriously curtail them, diminishing clinical investigation and education alike with a consequent negative effect on patient care.
The case for commercial support
The 2012 case for commercial support, made by a part-owner of a medical education company and of an accredited provider receiving grants from public and private sources including medical products companies, held that the Patient Protection and Affordable Care Act, enacted in March 2010, set out to improve health care quality and efficiency while reducing costs and unnecessary spending, but did not address the continuing education clinicians would need to achieve it: the administration and the federal health agencies expected doctors and health professionals to work together across disciplines, use health information technology, update their coding to ICD-10 and meaningfully use electronic health records, without providing a direct mechanism, let alone funding, to educate them about those expectations. In a survey reported in 2012, 52.2% of physician respondents said they had had to spend more time and effort locating appropriate CME, and 25% reported that the quality of their continuing education was decreasing. On this view, curtailing commercial support would dramatically diminish access to appropriate, high-quality education and negatively affect patient care, and studies had shown commercially supported programmes positively affecting patients in intensive care and patients treated for chronic obstructive pulmonary disease, hypertension, sepsis and hospital-acquired infections. It added that patients benefit from education that reaches health care providers in practice now, the country's health problems will only grow with an ageing population and a growing epidemic of chronic diseases, and the quality of care depends on access to education that integrates new advances into patient care.
On bias, it held that new standards of commercial support create a principled firewall preventing undue industry influence. In its account, providers who accept commercial support, and the CME writers they hire, strictly adhere to numerous codes and guidances to eliminate potential bias or conflict of interest, including the accreditation council's Standards for Commercial Support, the Office of the Inspector General's guidance, FDA guidance, and the PhRMA and AdvaMed codes of conduct, and the CME Coalition, an advocacy organisation of CME stakeholders, had announced a CME code of conduct to bring clarity to the rules governing CME. It cited three large studies, conducted independently at the Cleveland Clinic, at Medscape and at the University of California, San Francisco, and published in peer-reviewed journals in 2010, as producing substantial data providing evidence of a complete lack of commercial bias in industry-supported CME. It concluded that it was time to stop focusing on who supports continuing education, because the proper firewalls are in place to ensure quality, integrity and independence.
The case against commercial support
In 2010 the pharmaceutical and medical device industries spent an estimated $17 billion on promotional education, including detailing, promotional speakers and promotional mailings, and $831 million supporting accredited CME. The opposing 2012 case held that in the midst of that $17 billion deluge of advertisement and education, patients and doctors deserve a small island of absolutely unbiased medical education, so the American Medical Association's PRA Category 1 Credit should be devoid of commercial support.
The opposing case granted that if everyone actually followed the accreditation council's Standards for Commercial Support, which are intended to ensure independence in CME activities, all CME, industry supported or not, would be unbiased. Standard 5.1, which that case called the crucial criterion for unbiased CME, states that the content or format of a CME activity or its related materials must promote improvements or quality in health care and not a specific proprietary business interest of a commercial interest. It held that the standards are enforced laxly, that extraordinary financial incentives have made rule-breaking the norm rather than the exception, and, in its author's experience, that noncompliance is the daily reality of industry-funded CME.
Of the many medical writers at companies specialising in commercially supported CME with whom that author had spoken, he could not recall one who did not perceive pressure to bias their work in favour of the sponsor. Sometimes the pressure was blatant, as when a writer was given a set of slides developed by the supporter's marketing department and instructed to create a CME review article giving particular prominence to the sponsor's drug. In other instances it was more subtle: several writers told him of being ostensibly given free rein on a topic while understanding that the unspoken expectation was that certain unfavourable studies about the supporter's product would be omitted or explained away. None of these writers felt good about it, but they did it for the opportunity to make money doing an activity they loved. In his view, to the extent that medical writers rationalise their way through such assignments, the integrity of their profession is diminished, and doctors who take part in preparing biased CME articles, as guest authors or as legitimate coauthors, equally degrade trust in the CME process.
As that author noted in 2012, there were no multisite double-blind trials proving that commercial support of CME adversely affects medicine. There were studies showing that physicians can be influenced by industry salesmanship of various kinds, but to his knowledge no adequately designed studies proving that commercial support is pernicious under the current accreditation standards, and he could think of no feasible design for such a study and no plausible funder for one. Commercial support of CME is, on this view, primarily an issue of ethics and trust rather than a scientific one, like conflicts of interest in other fields where professionals are vulnerable to corrupting financial incentives: judges are subject to recusal in cases in which they have a financial interest, newspaper reporters cannot be paid by parties with an interest in the subject of their reporting, and sports referees cannot accept money from a particular team. He knew of no scientific studies proving that each of these policies protects the public welfare, yet held it self-evident that judges, reporters or referees who accepted money from parties standing to benefit from their decisions could not be trusted, and analogously it is difficult to fully trust any medical educator paid to educate by a company with a financial stake in the content.
The American Medical Association's ethical guidelines, which that author judged reasonable, do not absolutely forbid commercial support of CME, but make clear that the ideal is for CME not to receive commercial support and not to involve faculty with ongoing financial relationships with companies making products relevant to the CME topic. The guidelines came from the association's ethics committee, the Council on Ethical and Judicial Affairs, rather than from one of its scientific committees.
What learners report
By 2023 many reports and editorials had asserted that commercially supported continuing education is biased in favour of the funder's products, some calling for a total ban, but none cited empirical evidence of bias due to commercial support, perhaps because so few studies had systematically examined the issue. A careful literature search reported in 2023 found only four studies conducted after 2004, when the accreditation council first released more rigorous standards, that relied specifically on feedback from clinicians taking part; they were published from 2010 to 2012, none found evidence of bias, and no empirical study on the topic had been published since.
The Cleveland Clinic's continuing education centre analysed 95,000 evaluation responses across 346 activities held in 2007: a mean 98.4% of participants answered yes to whether the activity was "satisfactorily free" of commercial bias and a mean 97.2% rated its freedom from commercial bias excellent or good, and activities were considered free of commercial bias by 98.5% of respondents when they had a single support source, 98.3% when they had several and 98.0% when they had no commercial support. A study of evaluation responses for 213 accredited live courses at the University of California, San Francisco, from 2005 to 2007, about 33% of them without commercial support, found a median 97% of participants perceiving no commercial bias, with a median 132 participants per programme, and no association between the degree of perceived bias and the extent or absence of commercial support. Evaluations from 1,064,642 physicians in 3,137 Medscape online CME activities, 28% of them industry supported, found 0.63% disagreeing or strongly disagreeing that an activity was "presented objectively and free of commercial bias", 0.84% for commercially supported activities and 0.48% for the rest.
Among more than 1,500 attendees of live CME programmes held in 2006, 2007 and 2010 that received no commercial support, 6% to 9% across programmes answered "yes" or "somewhat" when asked whether commercial support had influenced content selection, and about 75% of those who rated a programme biased also rated one or more of its lectures biased. These findings suggest that clinicians may perceive commercial influence as something beyond commercial support itself.
The 2023 review of these studies concluded that it seems fair to say that, at least from clinicians' point of view, commercial bias in CME is quite low and independent of commercial support, and that the protections in place, prominent among them the accreditation council's standards, would seem to be working; but more, and more definitive, research is needed. In the meantime it remains crucial to safeguard against bias: everyone involved in developing content, medical writers included, must be aware of the potential for bias and work to mitigate the risk. Medical writers can play an important role in oversight by ensuring that the content they develop is fair, balanced, unbiased and accurate.