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Inform or influence

Fear of pharma bias may restrict doctors' access to essential continuing medical education

An illustration of a remote-controlled car using the letters CMEThe European continuing medical education (CME) environment is evolving significantly; pharma used to look at it with foot-shuffling inquisitiveness, but is now more willing to question its potential. Pharmaceutical companies are considering whether steering clear of it puts them at a competitive disadvantage or if providing a grant for CME would benefit them – especially in today's tightening regulatory environment.

Recently there has been a shift away from the traditional approach of spending most of the budget on pure promotion as companies look for new ways of relating with their customers. The feigned innocence of some doctors, as they accepted all manner of gifts and inducements associated with product promotion, is at an end.

The genie of product promotion is also out of the bottle and doctors know when they are being sold to. Pharma has learnt that each message – however effectively targeted and disseminated – goes through a filter before, hopefully, settling in the mind of the prescriber.

Consumer credit
Doctors behave much like any consumer when faced with a promotional or educational message. When considering buying a family saloon car, we would think it strange if we stepped into a Toyota dealer and they told us that the best car was a BMW. We know this, and we amend our approach.

As consumers, we have learned how to hold independent opinion in higher regard. We are more likely to reach for a car magazine or a consumer report before taking a promotional brochure at face value.

The same applies in pharmaceutical marketing with drug companies steering clear from any hint of being seen as pedlars of products, choosing instead to position themselves as partners in patient care or supporters of patient-centric initiatives.

For over a century, pharma has seen the benefits of being perceived as a credible font of knowledge about products and diseases, but could this be extended to support, or even provide, unbiased education? At first glance, CME could be considered a tactical tool suitable at any stage of the product life cycle, and perfect to address any target audience profile. However, developing an educational continuum – that places CME into context with other activities and educational outputs commonly employed by pharma companies – paints an interesting picture.

Education continuum
Imagine at one extreme of a promotion–education spectrum the most promotional thing a pharma company could do: the press advertisement. Everything about a product distilled into a few pithy words with apt image, supported by evidence where required, along strict promotional rules and regulatory requirements. As with the ads that we, as consumers, encounter when reading the Sunday newspaper colour supplements, everyone knows the rules of the game – what it is, what it is about, and what it is trying to achieve. We also understand that someone, somewhere, controls this, and when it comes to pharma, each ad must comply with EFPIA or local national codes.

The detail aid, further along the continuum, also contains subjective information, but also objective opinion and third-party data. After all, credibility comes with someone else blowing your trumpet, and independent studies and experts are important in supporting a message.

Plausibility increases with experts reiterating their viewpoint in person, maybe during a satellite symposium or a stand-alone meeting. Still some may feel that the expert has been paid to offer that opinion – "well, he would say that, wouldn't he?".

The company can detach itself further from the source of the information in the search for higher levels of trust, by being demonstrably distant from an advisory board meeting, or just handing over funds with no expectations to a medical society as it develops practice guidelines.

The further away from proven, visible pharma control, and the more independent the expert, the higher the perceived credibility of the messages.

This is where CME should sit – education for the advantage of the learners, not for the benefit of the commercial company.

CME in various forms is establishing itself across Europe, taking its place in the ever-growing tide of continuing professional development that is omnipresent among all professions. CME as a global concept is crystallising into a common set of standards and expectations.

In Europe there is the illusion of a plethora of different rules being implemented in a beguilingly diverse variety of interpretations. In reality there are various dialogues taking place, hopefully leading to better mutual understanding, with accreditation bodies fine-tuning standards for CME.

Rules of engagement
The accreditation bodies do not allow for direct pharma interaction with CME, thus there is little scope for dialogue. If a company wants to support CME activities, it is reliant on third-party relationships.

Given that about half of all European CME is supported by pharma, it would help if EFPIA addresses in detail how pharma should engage with it and provide guidance on how members can demonstrate that they can be responsible educational partners.
Some individual pharma companies realise this and, in order to be seen to be acting responsibly, they are drawing up their own internal procedures and rules of engagement.

We hear from the US about the need for more transparency and more distance between pharma, as providers of funds for a CME activity, and the educational messages of accredited programmes. US pharma support of CME is under 360 degree scrutiny; from the public and the press, right up to the Senate. 

However, there is scant mention of the potential influence from the millions of pharma dollars given to research institutes, or to the senators themselves. Nor is the idea that doctors join every other profession and pay for their own continuing education given much consideration.

Opinion in Europe is somewhat more relaxed and relations with pharma are warmer. However, there is much disparity as to what is acceptable. In some cases it is possible for a drug company itself to present educational programmes that are CME accredited, in other situations this is utterly unthinkable. Even when a programme is developed completely devoid of any pharma control – other than unconditional funding – the sponsorship is under scrutiny. Unless the activity is multi-sponsored, it is not considered  independent enough to be accredited.

The CME bodies and the medical professional community need to agree just how closely they want pharma to be involved.

Meeting needs
CME is essential for doctors. Recognition of credits across borders, and the implications for meeting individual requirements are important issues to tackle. In general terms European CME must be clarified for both learners and potential supporters.
A programme-development process should begin with an evidence-based approach to needs assessment. This must set current clinical practice against published guidelines and what is considered best clinical practice. Any gap reveals a clear educational need.

From this, the learning objectives for the programme are set – not only the content, but also the delivery method – as well as some means to evaluate quality and relevance and gauge whether any bias has crept in.

The rules for commissioning and developing educational content can be tightened, but ultimately it is the learners who know whether the education has been of any use to them.

European forum
These are just some of the topics that will be examined in greater depth at the European CME Forum meeting taking place in London on November 18 and 19 this year. It aims to promote better mutual understanding, by bringing together the key stakeholders in European CME to discuss the issues.

Last year's meeting focused on the theory of European CME and how it was being put into practice. Delegates heard about the systems and aspirations for continuing education for doctors across Europe. Education providers presented examples of CME programmes and explained how they were put together.

This year, we will take a more thematic approach. Each aspect of CME will be under the control of an expert as they lead presentations, workshops and discussions.

As well as looking at accreditation developments across Europe, sessions will discuss how to assess educational needs, meet objectives and present these meaningfully. Issues of quality will be covered, as well as how to evaluate the role of pharma in CME – looking at managing bias and the factors that contribute to making high-quality programmes.

Questions about outcomes measurement will be raised, such as: Are we still reliant on doctors feeding back on how much they think that the education will affect their clinical practice – and voting with their feet if they don't like it?

Finally, now that e-learning can be accredited in all areas of medicine, there will be a session dedicated to deciphering these requirements. The new techniques and vocabulary will be explained so that delegates can better understand the important parameters in developing good online education.

CME is taking shape in Europe with many plans being put into place nationally throughout the continent. The European CME Forum meeting will endeavour to elucidate the intricacies of CME and how to best engage with it. If more relevant education is developed, then the ultimate aim of improving patient care will be met.

The Author
Eugene Pozniak is managing director of Siyemi Learning and programme director of the European CME Forum
To comment on this article, email pm@pmlive.com

7th October 2009

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