The independence rules for commercially supported education
Accredited continuing medical education keeps the company that pays for an activity out of its content. The rules turn on where an activity sits between education and promotion, where the separation came from, which roles it takes from the funder, what the current standards require, how far it reaches into a writer's other work, and the state laws and national industry codes beside it.
The education–promotion continuum
Medical education means education or training in unbiased scientific or medical content, but by December 2016 its practice spanned activities from more promotional to purely educational.
At one end of the continuum sits a press advertisement, fully sponsored by industry and promoting a specific product. At the other sits accredited continuing medical education and continuing professional development, the ideal situation, in which accredited providers deliver the education with funding independent of the pharmaceutical industry. Between them are the activities of medical communications agencies, mostly sponsored by industry, and those of public relations agencies, which are not usually accredited for CME.
Activities in the middle of the spectrum are provided by medical education providers, most often supported by industry, and aim to raise awareness or the profile of a specific therapeutic area by communicating results from basic, clinical or epidemiological research. That information is disseminated at satellite symposia, stand-alone meetings and advisory board meetings, which health professionals continue to regard as of high educational value even though the content is sometimes related to a specific product or device. Medical education providers include CME organisations, independent providers and, in some countries, universities, and they have no or limited industry support and provide educational content under strict guidelines, independent of any promotional motive or industry control. Medical education has kept its role as the mainstay medical communication tool.
Where the independence rules came from
Among the events that changed the regulatory environment of CME, a US Senate committee on labour and human resources, led by Senator Edward Kennedy, investigated pharmaceutical companies' promotional practices toward physicians. In 1990 the American Medical Association issued ethical opinions, guidelines governing physician interaction with the pharmaceutical industry. In 1997 the FDA issued a final guidance on industry-supported scientific and educational activities, whose policy distinguished promotional education from continuing medical education. The Office of the Inspector General published compliance guidance for pharmaceutical manufacturers requiring companies to separate sales and promotional activities fully from educational activities. Its report on the promotion of prescription drugs through payment and gifts confirmed that pharmaceutical companies continued to affect educational activities. The Pharmaceutical Research and Manufacturers of America issued its code on interactions with healthcare professionals, a voluntary code of ethics outlining proper conduct for the pharmaceutical and biotech industry's interactions with medical professionals. The Accreditation Council for Continuing Medical Education issued standards for commercial support requiring providers to create a firewall between commercial funders and educational content in an effort to eliminate bias in medical education. It then updated those standards to increase the requirements separating funders of CME from educational planning and content. It also updated its accreditation criteria to require providers to create a firewall between educational planning and content on one side and commercial funders on the other. A Senate finance committee report on the use of educational grants from pharmaceutical manufacturers acknowledged industry's efforts to prevent commercial influence of continuing medical education while stating that the measures are voluntary and that violations still occur. An Institute of Medicine report on conflict of interest recommended improving disclosure of financial ties between the medical community and industry, limiting payments and gifts, and removing industry influence from medical education. An American Medical Association report on ethical guidance for physicians and the profession with respect to industry support for professional education stated as policy that individual physicians and institutions of medicine must not accept industry funding to support professional educational activities. The federal Physician Payment Sunshine Act requires manufacturers and group purchasing organisations to report a wide range of payments to physicians and physician-owned entities.
In April 2007 the US Senate Finance Committee reported, after a two-year investigation, on the use of educational grants by pharmaceutical manufacturers. It concluded that oversight of CME providers by the accreditation council was insufficient to guarantee the required independence, leaving risks of kickbacks, veiled advertising of drugs and off-label promotion, and it faulted the council on three counts: its compliance standards still allowed drug companies to influence CME providers, its monitoring system did not evaluate accuracy, fair balance or commercial bias, and it did not identify activities that disproportionately favoured the commercial supporter's products. The Office of the Inspector General of the Department of Health and Human Services and the Department of Justice had brought, and continued to bring, numerous cases against pharmaceutical and device companies in the areas the committee outlined. Individual states had their own fraud and abuse legislation and were prosecuting such actions successfully at state level.
By 2010 the Institute of Medicine had reported major flaws in the way continuing education is conducted, financed, regulated and evaluated, and recommended creating a public-private, interprofessional institute to oversee those functions. One focus of the report, as expected, was preventing marketing messages from seeping into educational programmes. The Council of Medical Specialty Societies, representing more than 580,000 US physicians, said it did not support the proposed institute, partly because the report had not considered two innovations in continuing education, point-of-care learning and performance-improvement continuing education.
By 2012 perceptions of bias in industry-sponsored medical education had raised the importance of the bodies that govern and regulate CME and continuing professional development, such as the accreditation council. By accrediting programmes, such bodies address concerns over the objectivity of the programmes and their independence from commercial goals, and ensure that medical education is delivered in an environment free from brand promotion, although non-accredited medical education can still be of very high quality.
The roles taken from the funder
Perhaps as a result of the ongoing government and public scrutiny of commercially supported medical education, the accreditation council revised its policies again by 2008. Most medical education and communication companies were defined as commercial interests and so could no longer be accredited to provide CME activities or serve as joint sponsors, and such organisations had until August 2009 to revise their structure to one appropriately independent from marketing activities. Grantors could no longer suggest faculty, and could no longer review CME content for scientific accuracy.
Guidelines from the council that went into full effect in January 2009 redefined what kind of organisation may be an accredited CME provider, excluding any company that markets products or services used by patients, with certain exceptions for health care providers. They also called for separation between promotional and CME work in development and content, and companies selling products or services to patients could have no input into the content or the faculty of a CME programme.
In 2008 writers and editors in every practice setting were advised to stay apprised of the ongoing government investigation of commercial support of medical education and its continually changing regulations. Writers and editors were expected to be able to capitalise on the need for enhanced content validation that the updated standards created. Regulation of biopharmaceutical companies’ funding of medical education was expected to keep evolving over the following 12 to 18 months. Many CME leaders were expected to work to ensure the continued availability of industry support, demonstrate the valuable role of medical education and communication companies within the medical education enterprise, and enhance the integrity of commercially supported education.
In 2009 one speaker on CME singled out four of the council's six standards on commercial support as essential to an environment that demanded programmes free of interference: independence from any control over content; full disclosure to resolve any personal conflicts of interest; no advertising, trade names or branding incorporated into educational materials; and content and format without bias toward, or promotion of, any one view.
For one specialist medical society in 2009, the actions that bore on its accreditation included, in its meetings division, collecting financial interest disclosures, keeping advertising away from educational content and keeping a clear separation from symposia the society did not run. Commercial bias creeping into educational forums was one of the biggest issues the society faced, and a delicate balance for a non-profit: it wants advertising and sponsorship revenue, it would be easy to go overboard and accept any advertising and marketing exhibitors want, and some people would like to see no promotion at all. That year the society cut its sponsorship of pens, limited logo usage on bags and restricted giveaways at exhibitor booths, and the restrictions were expected to keep getting tighter.
In 2010 the council softened its earlier stance that industry employees could not serve as planners or speakers in accredited activities related to their company's products: activities may include scientific data presented or published by employees of commercial interests so long as the CME provider controls the content. Among the further examples of factors it lists for providers, and for writers, to consider in ensuring the independence of CME programmes, research by industry employees should not include patient care recommendations, and it should be at a basic-science level, be about drug discovery itself or cover very early, pre-product research, or else the target learners should themselves be scientists.
The Standards for Integrity and Independence
By 2023 there had for many years been layers of protection against commercial bias in continuing education: codes of ethics from the Pharmaceutical Research and Manufacturers of America, the Advanced Medical Technology Association and the American Medical Association, compliance guidance from the Department of Health and Human Services' Office of Inspector General, and the accreditation council's requirements, whose Standards for Integrity and Independence in Accredited Continuing Education give the most detailed guidance on content.
The council is the accrediting body for all national organisations that provide CE/CME and has a long history of concern about commercial influence. Its first standards meant to guide the relationship between CME and industry were released in 1992, and more stringent standards were put in place in 2004 to ensure the independence of CME activities, particularly with regard to conflict of interest. The major revisions of 2004 and 2020 progressively better defined and further restricted industry influence, among other priorities. The latest iteration, the Standards for Integrity and Independence in Accredited Continuing Education, was released in December 2020 and by 2022 had been adopted by seven other accrediting bodies across several health professions, and all providers in the council's system were expected to comply with it from 1 January 2022.
An ineligible company, the term that replaced commercial interest, is one whose primary business is producing, marketing, selling, re-selling or distributing health care products used by or on patients, and it is ineligible for accreditation in the council's system. Marketing by such companies includes advertising, sales, exhibits and promotion.
The five standards are to ensure content is valid; to prevent commercial bias and marketing in accredited education; to identify, mitigate and disclose relevant financial relationships; to manage commercial support appropriately; and to manage ancillary activities offered in conjunction with accredited education. The first three apply to all accredited education, the fourth only where an activity receives financial or in-kind support from ineligible companies, and the fifth only where there is marketing by such companies or non-accredited education associated with the accredited activity. Standards 1 and 2 are the most relevant to developing content.
Under the standards on bias, financial relationships, support and ancillary activities, the provider is responsible for protecting learners from commercial bias and marketing; for identifying relevant financial relationships between individuals in control of content and ineligible companies, and managing them so that they introduce no commercial bias; for keeping the education independent of a supporting company, so that the support results in no commercial bias or influence; and for keeping the education separate from marketing by ineligible companies and from non-accredited education offered alongside it.
The council endorses a system for the commercial support of continuing education in the health professions that aims to protect its integrity by erecting a firewall between commercial interests and the expert faculty who deliver instruction to learners. Standard 2 requires the accredited provider to ensure that all decisions on the planning, faculty selection, delivery and evaluation of accredited education are made without any influence or involvement from the owners and employees of an ineligible company. Ineligible companies also cannot recommend, or even suggest, names of faculty. Instructional content must be accredited by a third party, such as the council at national level or one of its designees at state level, to distinguish it from advertising. Pharmaceutical and device companies are ineligible to award credit but may provide commercial support so long as they comply with the council's standards. The writer serves the company developing a programme whose curriculum is overseen by expert faculty, and must not be influenced by any commercial supporter, so that the programme's integrity stays intact at each step of content development, from the grant proposal to the outcome report. The council has set high ethical standards aimed at protecting the integrity of accredited instructional content, and writers, who are involved in many stages of the content development process, are uniquely positioned to add or subtract integrity.
How far the separation reaches into a writer's other work
In August 2008 the council issued a proposed policy that would prohibit medical writers who write promotional information from controlling the content of CME activities on the same subject. Three officers of AMWA responded, calling for clarification of ambiguities in the proposal to ensure that writers are not unfairly barred from working in CME, and the original call for comments and the responses were posted on the council's website.
By 2009 separating promotional and CME interests was no longer only a matter for the accreditation council, where the risk is loss of accreditation or disallowed CME credits, but was increasingly becoming a matter of legal regulation. Given the mood against interference from commercial interests, the separation rule could be read as barring companies or even individuals from working on both kinds of programme, and at the least the barriers were high enough to make working on both kinds of project unpalatable for some.
By 2010 the tightening of regulations from their governing bodies required providers of continuing education to establish firewalls between their operations and any promotional activities, so a medical writer employed full-time by a CME provider could not serve a dual role writing promotional copy, especially in similar disease states. The rule technically applies to freelance writers as well, though many providers had traditionally enforced it loosely. Two leaders of CME bodies, the president of the commission that certifies CME professionals and the president of the Alliance for CME, said that as further scrutiny was placed on providers it was dangerous for freelances to expect to keep accepting work on both sides of the firewall. The commission's president said that good, compliant providers were asking writers what relationships they had with commercial interests, and that she would not hire someone to write a CME activity on breast cancer who had just worked on a promotional programme in that area.
The Alliance president added that everyone has the right to make a living and that she would never tell a writer they could not do something, but that a client has the right to ask and to make its own determination, and that the danger for a writer working on the same topic for a CME entity and a non-CME one is getting so close to the jobs that they no longer see the differences they are supposed to see, which can inadvertently put faculty and clients at risk. Some conflicts are easy to identify: working at the same time on a promotional slide deck for adalimumab and on a CME monograph on rheumatoid arthritis funded by its manufacturer, Abbott, would be a clear breach of the firewall. Others are trickier, such as a peer-reviewed, evidence-based review article about a different Abbott product, or meeting coverage from the American College of Rheumatology's annual conference for a medical news site that receives funding from Abbott. The answers are not always easy and largely depend on how tightly CME providers set up their firewalls, and some will prefer to hire freelances who focus strictly on CME work while others may be more lenient.
The washout between promotional and CME work
A freelance who wrote sales training materials for a new drug one month may be asked by a different client to write CME materials for the same drug the next. One freelance who does a lot of CME writing and also comes from a promotional writing background holds that switching between promotional and CME writing is not acceptable, pointing to the code of conduct of the National Association of Medical Education Companies, which states that staff and freelances who control content for promotional education should wait an appropriate length of time, such as a washout period of 6 to 12 months, before working on educational content in the same therapeutic area, and that accredited providers should verify this washout for staff who control content.
The washout does not apply to a writer moving from CME writing to promotional writing. In the same writer's view, the rule may arguably infringe a freelance's right to fair trade, but given the ethical issues that could arise when a writer switches between promotional and CME work in the same therapeutic area, some washout period seems both reasonable and advisable.
If he met such a conflict, he would tell the client that he is, or has recently been, involved in promotional work in the same therapeutic area. Because the code gives the period as a range, he would work out a suitable washout period with the client and, if that precluded the CME project, decline it respectfully, help the client find a suitable alternative writer, and try to use the situation as a marketing opportunity to promote his commitment to high ethical standards.
State laws on industry interactions
A 2008 Massachusetts law, the Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care, funds an evidence-based prescriber education programme developed by the state with the University of Massachusetts Medical School, and severely restricts or prohibits industry from offering the cost reimbursement, meals, activities and travel that have in the past been associated with CME programmes. In 2009 a further 25 to 40 states were expected to propose new laws affecting pharmaceutical companies over the following year, the increase being due to the support recently approved laws had been given in court. Those proposed and newly approved state laws covered all aspects of the interactions between pharmaceutical companies, health care providers and patients, including gifts, consulting, speaking engagements, sales representative interactions, advertising, and data mining of health care provider information.
Industry codes in each country of delivery
By 2012 tighter control over the format, content and delivery of medical education meant that special care had to be taken to design every initiative in line with the codex requirements of the country in which it is delivered. Beyond creating fair and balanced educational programmes, it is crucial to ensure full transparency about industry sponsorship and about author and speaker conflicts of interest. Strict codes of conduct defined by bodies such as the International Pharmaceutical Congress Advisory Association, the European Federation of Pharmaceutical Industries and Associations and the Association of the British Pharmaceutical Industry mean that all major pharmaceutical and device companies have entire medical and legal teams dedicated to ensuring that their sponsored medical education activities are fully compliant, fair and balanced, and non-promotional.