Schooling doctors

Sometimes it is hard to see why we do it as an industry… Not only do we spend billions of dollars on sponsoring continuing medical education (CME) each year, we meekly accept that we are about as welcome at the CME party as someone with swine flu, and – to top it all – we take grief at the hands of the medical media for our "evil" funding of "biased" CME programmes.

That CME is here to stay in both the US and Europe is not in question, but whether our industry will continue to be the main sponsor of accredited CME programmes is indeed. The next few years will be interesting – there is a trend towards mandatory CME across Europe with increasing need for sponsorship, over 50 per cent of all CME sponsorship in Europe currently comes from industry, but calls are echoing around the world to end pharmaceutical company sponsorship of CME.

The pharma industry may be getting cold feet with respect to CME. Despite increasing requirements for physicians and healthcare professionals (HCPs) to undergo CME, and thus, in theory, an opportunity for our industry, the level of commercial sponsorship seems to be decreasing. In June last year we were astonished to see Pfizer, one of the largest CME sponsors in the US, completely pull out of CME provided by for-profit, third-party companies.

At the time, Pfizer's chief medical officer, Dr Joseph Feczko said: "We understand that even the appearance of conflicts in CME is damaging and we are determined to take actions that are in the best interests of patients and physicians." In keeping with this we may be coming to realise that the CME playing field is complicated and probably neither level, or fair, to us as an industry.

In answer to the question "What is the future of CME across Europe?" many people would probably call for the crystal ball – one thing is certain, we are likely to have times of change ahead.

Accredited CME
In the US, where mandatory CME has a longer history than in Europe, doctors have for many years been required to earn CME credits to retain their medical licenses. Credits are earned by taking courses, attending medical conferences, by reading and taking a test, or by completing online programmes. The main accrediting body is the Accreditation Council for Continuing Medical Education (ACCME).

ACCME defines CME as "educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. The content of CME is that body of knowledge and skills generally recognised and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of healthcare to the public."

In Europe, accredited CME has historically been a strictly national affair, in part due to the complexities of mutual recognition between countries of CME credits. Also, in contrast to the US, mandatory CME has been relatively uncommon in Europe – even today, among major European countries, although CME is mandatory in France, Italy, and Germany, it remains voluntary in Spain and the UK. No compulsory revalidation system is yet in place in any of these countries, although in the UK this is being introduced as part of a relicensing process.

Over a decade ago, the lack of accreditation for participation in international CME activities was recognised and the European Union of Medical Specialties (UEMS) was created to harmonise CME across Europe in the different medical specialties. UEMS created the European Accreditation Council for CME (EACCME) in 1999, which has become the main body involved in European accreditation of international events and the granting of wider recognition across Europe of nationally accredited programmes.

EACCME is tasked with "harmonising and improving the quality of specialist medical care in Europe by structuring and facilitating the mutual recognition of accreditation of CME/CPD activities through the awarding of European CME credits to individual medical specialists throughout Europe." EACCME defines CME as "educational activities which serve to maintain, develop or increase the knowledge, skills and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. Therefore all continuing educational activities which assist physicians in carrying out their professional responsibilities more effectively and efficiently are considered as falling into the scope of this definition."

Initially EACCME was focused on accreditation of European events, but on 1 January 2009 UEMS also approved e-learning for European-wide accreditation and it is anticipated that enduring materials will also join the list of activities suitable for international accreditation in 2009.

Accreditation process in Europe
The process for European accreditation is fairly simple, and using the EACCME process avoids having to apply to each national accreditation authority to have a programme recognised across different European countries. In addition EACCME accreditation is recognised in the US, as the EACCME and the American Medical Association (AMA) have a mutual recognition of CME credits between Europe and the US.

After online application (submitted not later than two-three months prior to an event), the application form is distributed to the relevant national accreditation authority of the country where the activity (eg, event) will take place and the relevant UEMS Specialist Section and/or Accreditation Board that assesses the scientific value of the activity. Approval or a refusal for accreditation, plus the suggested number of credits is provided within three weeks. The sponsor is required to pay a fee that is calculated on a sliding scale based on number of participants.

As the different national accreditation authorities apply different credit systems, European CME Credits (ECMECs) have been introduced to harmonise the number of credits on the following basis: one ECMEC per hour; three ECMEC for half-day; and six ECMEC for a full-day. National authorities can then convert these credits into national units, following their own national credit system.

Sponsorship of CME
Over half of all CME activities in Europe and the US are sponsored by industry and this has grown dramatically over the past decade. Detailed financial data are available for the US but comparative numbers do not appear to be available in Europe – however, the trends appear to be similar, albeit with Europe lagging behind in timeframe.

Commercial support for CME accredited by ACCME in the US quadrupled between 1998 and 2006 – from $302m to $1.2bn. In 2006, the combined for-profit support (commercial support and advertising and exhibit income) represented 60.6 per cent of total income for ACCME. This in turn made a lucrative business for CME providers resulting in an explosion in their numbers. The profit margin for ACCME-accredited providers increased from 5.5 per cent in 1998 to 31.0 per cent in 2006.

However, this trend appears to be reversing, with significant reductions in industry sponsorship in 2008 vs 2007. The ACCME annual report 2008 claims an overall reduction in CME spending in the US from $2.54bn in 2007 to $2.37bn in 2008, the first year-to-year drop since ACCME was founded. The reduction is almost completely due to reductions in commercial CME sponsorship, which fell from $1.2bn to about $1bn.

Is sponsoring CME a good use of our funds?
As usual, there is considerable industry-bashing by the media with respect to our 'evil' motives in funding CME. We probably have to accept that we are guilty until proven innocent.

In July 2009, the Office of Inspector General (OIG) Chief Counsel testified before the US Senate about the risks of commercial sponsorship of CME. It seems that any benefit to industry from CME is unacceptable. He cited a study suggesting that "the return on investment for pharmaceutical promotional strategies indicates that spending $1 on physician events and meetings, including CME, generated an average of $3.56 in increased revenue."

He also cited criminal kickbacks to physicians and others. Although he stated that: "The surest way to eliminate commercial bias in CME is to eliminate industry sponsorship by funders who have a significant financial interest in physicians' clinical decisions," he also recognised the need for industry sponsorship to maintain the availability of CME. He therefore advocated approaches that would allow continued access to industry sponsorship of CME, but limit industry's ability to influence how that money is used and what messages physicians receive. The message is clear – keep giving us the money, but keep your noses out.

Pharmaceutical input is so unwelcome that even when we have something to offer, our involvement is suspicious. A recent article cites – presumably as its best example of inappropriate commercial influence – a CME provider having been found to have written to the sponsor. "Could you please suggest a couple of speakers for our scientific committee's approval?", which the pharmaceutical company did. This does not necessarily mean bias in a programme, and a pharmaceutical company working in a particular field would be expected to know who the knowledge leaders in the field are.

To have spent the amount we have on CME we must have felt it brought benefits. People say CME is important for heightening corporate profile; showing commitment to supporting a certain disease area; creating an interest in a certain disease area; raising awareness among the prescribing community and improving relations with clinicians and thought leaders.

Given that the limitations in the US on sponsors' involvement in any aspect of CME content is almost complete, ie, the sponsor has no say whatsoever – and an apparent trend in this direction in Europe, sponsorship of accredited CME programmes may become less attractive. Amid a plethora of articles such as "Doctors' education: the invisible influence of drug company sponsorship," we may feel that other non-accredited medical education programmes are a better way to spend our money – still able to provide high-quality, balanced educational activities such as publications, online education, preceptorship programmes, etc, but without what appears to be rather zealot anti-industry fervour that surrounds accredited CME.

The future
In Europe, there is likely to be a growing shift from voluntary to mandatory CME and increasingly required validation. Thus it is likely that HCPs will become more attracted to programmes that allow them to earn their required credits. This means that, as an industry, obtaining accreditation for our programmes would help to ensure participation by HCPs.

However, CME is expensive and if we can have no say whatsoever in content, and our sponsorship has the potential further to  diminish our already tarnished image, one wonders if this area will grow or whether we will slowly reduce our funding and use it to sponsor other educational activities where we can have some input. Given its relative value for money and broad reach, I anticipate we are also likely to see an increase in e-CME.

If we follow the current trend in the US, we are likely to see accredited CME decrease in Europe. Somehow this all seems a shame as high-quality CME – recognised across European countries – is needed and the pharmaceutical industry is in a position to be a major sponsor. However, the number of burning hoops we are required to jump through – with any benefit to the sponsor criticised – may make it too unattractive in the future.

We seem to be left wondering today whether the pharmaceutical industry needs CME as much as CME needs the pharmaceutical industry. And if it all looks rather bleak for industry and accredited CME, one can only smile at the innovation of one company in the US offering "credits while you cruise," with trips around Alaska, Bermuda, Canary Islands, Rome, Hawaii, Caribbean, coupled with onboard CME learning. It is probably a very effective and convenient way for busy physicians to learn and keep up to date – but I'm glad that it doesn't seem to be a pharmaceutical industry initiative. However good and balanced the education might be, our critics would have a field day.

The Author
Dr Diana Barkley is president of PHOCUS Group
She can be contacted at diana.barkley@phocus.com

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