The Europeans are now joining the chorus for principled relationships with industry. The European Society of Cardiology (ESC) recently published a White Paper on the “Relations between professional medical associations and the healthcare industry, concerning scientific communication and continuing medical education (CME). The White Paper addresses the concern that industry funding of CME is biased or creates potential conflicts of interest.
ESC recognized that, “Physicians have an ethical duty to keep up-to-date with current knowledge.” Professional medical associations such as the ESC support these obligations. All cardiologists must be familiar with the latest developments so as to offer to patients the best possible care. One of the best ways of making sure clinicians are at the cutting edge is through CME. In fact, 16 European member nations mandate CME for the revalidation of their license to practice.
However, ESC also noted how, “CME is expensive and relying completely on public funding is not a viable option for Europe at the current time, and nor is it likely to be so in the foreseeable future.” It is therefore the ESC’s “view that in the absence of alternative funding, maintaining links with industry is appropriate – and indeed necessary – as long as educational and scientific products remain independent, effective and unbiased, and as long as the relationships between ESC experts and industry are transparent and appropriately disclosed.”
In fact, they noted that, “If the calls to ban industry support of medical associations were to be heeded before alternatives were in place, then opportunities for CME would be severely compromised.”
Background
Cardiology is a complex and fast moving specialty. Medical advances have often come from basic and clinical research carried out by academics, pharmaceutical and medical “device” companies alike. However, communicating these findings to medics and clinicians could, it is naturally perceived, lead to a degree of bias as organizations look to promote their findings in a positive light.
In other words, communication may lack objectivity for commercial reasons, and so when industry supports CME activities or scientific meetings, there is a risk of bias. Consequently, there “are many divergent views from different quarters” on how to address and minimize this risk of bias.
To minimize the chance that commercial influences might sway clinical decisions, there have been calls for medical societies to be funded from membership dues, subsidies and foundations rather than through grants from industry. Examples include the Macy report in the US, or the position taken by the Royal College of Physicians in the United Kingdom, which favors cutting ties between industry and medical education.
The debate surrounding commercially supported CME within the medical profession and in the media focuses on the influence of the healthcare industry on prescribing patterns and on the use of medical devices by healthcare professionals. “The fundamental concern is that ties with the pharmaceutical and device industry lead to real or perceived ethical conflicts. This may affect prescribing patterns and the selection of drugs for hospital formularies.”
The White Paper from the ESC aims to address these concerns and outline why it believes certain actions should and should not be taken, and how the best interests of patients are to be served.
Why CME is Vital
The goal of CME is to develop, maintain, or increase the knowledge, understanding, procedural skills, and professional performance of physicians, to enable them to provide the highest quality of care for their patients. All educational programs, irrespective of whether they originate from the ESC, other CME providers, industry, or regulatory bodies, should adhere to essential guiding principles. They should be:
- evidence-based,
- have both clearly defined educational objectives and target audiences and
- also be free of commercial bias.
Courses must be evaluated on the basis of their scientific merit, quality, practical utility, perceived evidence-base, potential bias, innovation, and teaching methods. CME is provided by several different types of organization, from societies such as the ESC, pharmaceutical and device companies and more recently for-profit CME companies.
The educational activities of the ESC and similar activities by other medical associations meet important societal and professional needs. The mission of the ESC is “to reduce the burden of cardiovascular disease in Europe” by providing balanced and neutral educational resources and scientific communication. It assists specialists to improve their professional standards.
For example, the ESC Congress is attended by some 25,000 professional delegates from around 140 countries. Scientific, educational, and clinical practice sessions are organized by the Congress Program Committee, which has about 50 members, none of whom are industry employees. Roughly, 10,000 scientific abstracts are submitted and approximately 40% are selected for presentation after a systematic and anonymous peer review process.
On its website, ESC offers educational resources such as e-learning programs, webcasts, slide archives and on-line access to the scientific abstracts of its congresses. In addition, the ESC publishes seven peer-reviewed general and specialist cardiology journals, from which around 4.5 million electronic downloads are made each year.
While these activities are organized independently by the ESC, their costs are offset both indirectly and in part by funding that the Society receives from the healthcare industry. The exhibition at the annual ESC Congress allows attending cardiologists to receive up-to-date information on diagnostic and therapeutic products, which they might consider using in clinical practice. Finally, and importantly, satellite symposia organized and supported by industry are clearly identified in the program as being separate from the scientific sessions organized by the Congress Program Committee.
The ESC asserted that it “is ideally placed to provide CME since its members represent a critical mass of experts in every field of cardiovascular medicine across Europe and the Society is already at the forefront of CME “best practice” by bringing professionals together at its major Congresses and keeping them up-to-date through initiatives such as e-learning, for example. The ESC also has robust code of conduct which ensures transparency, while its role in this important area will help it to accomplish its mission of reducing the burden of cardiovascular disease in Europe.
Ensuring transparency
ESC noted that it is particularly important that any collaboration between the medical profession and industry is completely transparent and that educational objectives are paramount. The ESC has adopted a specific code of conduct; this assures the provision of unbiased, evidence-based and high-quality continuing medical education in cardiovascular medicine. A sample of these well established, effective and robust measures include the following:
- Every member must fill in a declaration of interest form
- Sessions for any programme must be based solely on scientific merit
- All chairpersons and speakers must (when delivering a session) show a slide with their disclosure of interests and the audience must have time to read all of its contents
- Company products must not be advertised in the lecture theatre, meeting room or conference hall
- The requirements for transparency are the same for distance learning courses and internet-based educational activities
The requirements for transparency when it comes to Clinical practice guidelines are equally robust and rigorous. There are also guidelines regarding ESC cardiology journals, observational research and registries details.
ESC recognized that, “Links between industry and clinicians are essential, especially given the lack of government or alternative funding.” Nevertheless, because of the potential for bias, ESC noted that, “The links between industry, healthcare professionals and medical associations must be reviewed critically to ensure these relationships are both ethical and transparent.”
ESC noted that it would be in the best interest of healthcare companies “to provide education for clinicians that is accurate and impartial, instead of offering promotion that is commercial,” because “If the correct treatment is applied to the right patient at the right time, then the maximum benefit may be achieved for both the patient and the company.”
They noted that, “unrestricted grants” may be a way forward, where money is given with no say in how it is spent in terms of education or course content.
Discussion
Already all promotional and education activities of industry are bound by strict regulations, from bodies such as the European Federation of Pharmaceutical Industries and Associations (EPFIA), the International Federation of Pharmaceutical Manufacturers Associations, the UK Bribery Act and the US Foreign Corrupt Practices Act of 1977.
Healthcare providers, educators, professional associations and industry must act both collectively and individually to acknowledge and eliminate real or perceived bias.
The ESC advocates a principled and balanced approach that acknowledges disclosures of interest between healthcare professionals and industry, and aims to provide honest and unbiased education for healthcare professionals. It does not believe severing ties with industry is in the patient’s best interest.
ESC recommended that other medical societies “develop a constructive partnership with industry, in a transparent, productive, and ethical manner.” To achieve this, the trust not only of the public, but also of healthcare professionals, governments and regulators, must be retained and be respected.
Ultimately, ESC noted that, “Science-driven collaboration between professional societies and industry can be mutually beneficial, ethical, and appropriate.” To achieve this level of integrity, the personal interests of all parties involved must be stated clearly from the outset and due care must be paid to ensure that governance and processes are in place to protect the ultimate beneficiary – the patient.