Doctors, medical education and pharma – the way ahead

pharmafile | February 9, 2012 | Feature | Medical Communications |  ABPI, ASME, CME, Continuing medical education, GMC, MEP 

InPharm CME event

Roy Pounder, Andrew Powrie-Smith, Richard Marchant, Roy Lilley, Kieran Walsh and Chuka Nwokolo are all speakers at our ‘Medical Education in Practice’ event being held in London on 18 April. 

Register at: http://www.inpharm.com/mep2012

It is a difficult time for continuing medical education in the UK. Concerns about transparency and questionable practice continue to press in on the sector, despite concerted efforts by industry and other stakeholders to avoid replaying any past misdemeanours. 

The ABPI Code has been updated to reflect a more vigilant climate around sales, marketing and CME activities, notably incorporating the disclosure of aggregated data on payments to doctors and other healthcare professionals from spring this year. 

Reports of undue influence or data-massaging continue to surface in the media, though. Yet some med comms agencies complain that companies are now treading too carefully, stifling valuable medical exchange. Current economic conditions and the government’s faltering NHS reforms further muddy the waters. The drive for cost savings in the health service does not bode well for internal CME support.

At the same time, the five-yearly revalidation scheme planned for introduction towards the end of this year sharpens the need for time-poor doctors to show they are staying ahead of the game.   

With industry also tightening its belt and nervous about stepping over the line in its transactions with the medical profession, how amenable will it remain to filling these gaps? 

GMC consultation

Having absorbed the responsibilities of the Postgraduate Medical Education and Training from 1 April 2010, the General Medical Council has been considering how best to exercise its role in regulating doctors’ continuing professional development, particularly in relation to the new demands of revalidation.

As a GMC working group stressed in a report last September, though, the aim is “not to prescribe what CPD doctors must do or how they must do it, but to provide a framework of principles around which doctors should plan, undertake and evaluate their CPD activity”. 

The impetus for the GMC’s review was a recommendation from Lord Naren Patel that the regulatory function in CPD should be re-examined “so as to support doctors in meeting the requirements of revalidation and providing high quality care for their patients, whilst preserving the value of CPD for individual professionals”.  

Lord Patel also noted in his report commissioned by the GMC and the PMETB that the Council’s last guidance for doctors on CPD dated back to 2004 and needed to be refreshed. Draft revised guidance went for consultation, along with the working group’s recommendations from last September, between 17 October 2011 and 27 January 2012. 

Once it has analysed the responses, the GMC hopes to get the updated guidance signed off in the spring and published in early summer. The challenge then will be to work with NHS employers on embedding these principles into medical practice, notes Richard Marchant, the GMC’s associate director of Regulation Policy. 

The draft guidance confirms that responsibility for identifying CPD needs, planning how they should be addressed and undertaking relevant learning activities lies with doctors themselves. It does underline, though, the parallel responsibility of employers and contractors to “ensure that their workforce is competent, up-to-date and able to meet the needs of the service” and to “facilitate access to the resources (including the time to learn) that will support this”.

While the GMC will be taking on a ‘more facilitative’ role in the regulation of CPD – “not so we tell them what they’ve got to do but suggest what information might be relevant for them”, as Marchant puts it – the Council has resisted any direct involvement in its supply or accreditation. 

In a similar vein, it stresses there is “no single correct way of ‘doing CPD’”. Rather, the draft guidance adds, the evidence points to a range of different learning activities, both formal and informal, being the most productive.

What the GMC wants to avoid, Marchant explains, is too much emphasis on inputs and ‘counting credits’ that reduce the process to a ‘tick-box minimum’. 

Where industry sits

So where does industry sit in all of this?   

In terms of the new draft guidance, nowhere, although that does not imply industry is no longer welcome. Rather, it puts the ball firmly in the court of doctors and their employers. 

Indeed, there are indications in the current economic climate of ‘tension’ around the availability of resources for CPD, while employers “understandably want bang for their buck”, Marchant acknowledges. There is ‘nothing intrinsically wrong’ with organisations that have a financial stake in a particular product offering training courses in the use of that product, as long as everyone is absolutely clear on the context, he says.

In many cases, that training might not be otherwise available, “so one needs to recognise the reality of these situations”. 

Less and less

For Chuka Nwokolo, honorary Professor of gastroenterology at Warwick Medical School, the reality is that probably 20-30% of CPD is fuelled directly or indirectly by the pharmaceutical industry.

On the other hand, industry is doing ‘less and less’ in this area, something Nwokolo puts down partly to increased ethical awareness. Certainly the days of being flown out business class to Los Angeles for a week-long meeting and five-star hotel accommodation are ‘pretty much gone’. The difficulty is, though, that doctors are ‘caught in a pincer’, whereby the pressure to meet targets has ‘never been so intense’, yet they have to ‘eke out enough time’ to secure the required learning credits over the five-year revalidation cycle.

But it is ‘almost impossible’ to get a NHS Trust to fund trips to meetings, Nwokolo complains. And educational courses, which he says are generally paid for out of pocket, do not come cheap. According to Nwokolo, the ‘hand of pharma’ manifests itself in a variety of ways across the CPD spectrum.

Companies may sponsor educational ‘grand rounds’ in hospitals, with a sales representative and leaflets in attendance. Seminars and workshops are another channel for support. There may be reps supplying tea and coffee at hospital breakfast meetings, although they are ‘not allowed to say anything’. Then there are the big international meetings, where there is a ‘huge’ pharma presence.

All the same, Nwokolo adds, it is ‘very tough’ for the industry to show the necessary degree of altruism. Regulatory bodies and medical bodies are ‘constantly on the lookout’ for inappropriate influence and will not allow credits for educational activities if they detect it. It can be hard attracting sponsorship for meetings without a promise not to ‘bang the drum’. 

The downside is in areas where doctors have relied on ‘soft money’ from industry in the past, such as in medical research. As Nwokolo explains, there are ‘established researchers’ in the UK with a track record who tend to monopolise peer-reviewed grants. Orphan researchers often break through that ceiling by recruiting patients for clinical trials and then using the funds to develop their own track record. But “a lot of that is lost”, Nwokolo comments.

Journal transparency

As he points out, one other way for doctors to secure CPD credits is by reading medical journals, most of which feature pharmaceutical advertising. Journals are also a crucial platform for industry to report clinical trial results and alert doctors to promising new compounds.

Journals such as the BMJ have been giving industry a particularly hard time of late over issues such as clinical data transparency, while influential critics such as Dr Ben Goldacre insist doctors cannot make properly informed decisions on medicines without full datasets at their disposal. As far as Roy Pounder, Emeritus Professor of Medicine at the University of London and co-editor of Alimentary Pharmacology & Therapeutics, is concerned, it is the transparency part of the equation that really matters. In this respect, his own publication is in a position to stand tall.

It recently ran a study on funding source and conflict of interest disclosures by authors and editors in gastroenterology specialty journals revisited (J. Qureshi, A. Sud, N, Vakil), in which a review of 1,574 articles from 15 leading journals, identified Alimentary Pharmacology & Therapeutics as one of just three journals that reported the presence or absence of funding sources in all of their published original pieces.

It was also one of only five journals to disclose publicly editors’ conflicts of interest. Pounder says the publication has “worked very hard to be as squeaky clean as we can”. But he recognises the limitations inherent in a universe where ‘everyone consults at some time’.

If you want access to expertise, then there has to be a ‘happy medium’, Pounder comments. The same goes for ghostwriting: Pounder does not disapprove in principle, as long as the ‘ghosts’ make themselves known – although “given the chance, people don’t admit it”.

He is also wary of arguments for ‘hosing out’ raw data from clinical trials, as Goldacre would put it. This is not an ‘equally balanced debate’, as for one thing regulatory authorities have a ‘very heavy hand’ in the way clinical trials are designed, Pounder suggests. 

The emergence of registries such as ClinicalTrials.gov means ‘most trials are now there’. And there are plenty of post-hoc analyses, although companies pursuing these risk being accused of ‘salami-slicing’. But the rows over selective reporting with products such as GlaxoSmithKline’s Paxil (paroxetine) are now past history, Pounder believes. 

One obstacle, he notes, is that journal editors are not keen on publishing negative data, particularly if they want articles to be cited as well as read. Digital media may offer a solution: for example, journals could publish a letter describing negative results and include a link to a registry such as ClinicalTrials.gov.

Open-access journals, perhaps offered as sister publications, may be another outlet for negative data, Pounder adds. There is a gradual movement from paper to electronic in medical publishing, although as yet “we don’t really know how to make money electronically”. And publishing more papers will dilute the impact factor of top-flight research, he observes.

Taking it seriously

From the other side of the fence, the ABPI has recognised that transparency is the road to a better public image, as well as legal peace of mind, and is taking it seriously. 

As Andy Powrie-Smith, director of Trust and Reputation, argues, industry provision and support of medical education is ‘very well regulated’ but continuing media attention to the issue means there is ‘reputational vulnerability’ both for companies and healthcare professionals.

In particular, he feels, there is a ‘time-lag’ in the media that ignores new Code requirements such as economy-class travel or appropriate accommodation, when funding is provided for doctors to attend meetings.

As bodies such as the GMC take a fresh look at CPD, though, the ABPI is trying to work out how its relationship with HCPs in this context can be optimised while dispelling the impression of promotion by the back door. The association has a group that meets on a quarterly basis with stakeholders such as the GMC, the Royal Pharmaceutical Society and senior figures from the medical Royal Colleges, and discusses how to take the relationship forward. More specifically, the ABPI has launched a research project to determine what the wider pool of HCPs thinks about pharma’s involvement in education, training and meetings, which elements of these transactions are valued, and which are a source of discomfort.

The exercise started with qualitative interviews across the spectrum of healthcare professionals during January and February. Learnings from these will form the basis of a quantitative questionnaire, to be conducted online through a co-branded portal in partnership with the Royal Colleges and other bodies involved in the quarterly discussions.

That should go ahead in May and last for about two months, “so halfway through the year we should have a really good idea of what the landscape looks like”, Powrie-Smith says. The ABPI will then report back to the stakeholder group and decide how to address strategically any issues of common concern.

Redefining the relationship

“It may be that there’s behavioural change on both sides, it may be that we need to communicate differently about the way certain things are done and what the outcomes are,” Powrie-Smith comments.

“It’s most likely to be a combination of both. I guess my sense is that the vast majority of what is currently done has value.” He is adamant that any appropriate response will not be made by industry in isolation. Medical education has evolved in partnership over many years and any solutions to current concerns must lie in addressing behaviours in both sides.

One of the problems, Powrie-Smith notes, is that CPD is a very broad church, extending all the way from “coffee and biscuits at a GP’s surgery, with a conversation with a medical science liaison about a new medicine” to “the American Thoracic Society Conference in San Diego, and all points in between”.

The trick, he adds, is “how to maintain all the content, and so on, that is valued but address the high expectations of stakeholders in terms of those reputational vulnerabilities”. Of course, companies also want to make the most of their investment in medical education, particularly in the current economic drought. But Powrie-Smith says the ABPI is “not picking up any particular trend to withdraw” from the field. 

One thing the industry does not want to see is more regulation. In Powrie-Smith’s view, there are already a number of vehicles through which both industry and the health professions give their members a framework to operate in. “Many companies are showing leadership in these issues, as are health professionals,” he comments. “A lot of it’s around redefining the relationship.”

Medical Education England

Medical Education England is a relatively new body established to foster a coherent professional voice on education and training matters for medicine, dentistry, pharmacy and healthcare science. 

MEE will advise the Department of Health on policy and will provide high-level scrutiny of, and advice on, the quality of workforce planning at national level.

Its role will include: 

• to bring a coherent professional voice on matters relating to education and training and advising the Department of Health on policy; 

• professional high level scrutiny of, and advice on, the quality of workforce planning at national level;

• professional scrutiny of, and advice on, the education training and commissioning plans developed at Strategic Health Authority (SHA) level;

• co-ordination of changes to postgraduate training pathways at a national level;

• integration of service and professional perspectives in curricula development; and

• liaison with other healthcare professional education national oversight bodies and relevant bodies in the devolved administrations.

MEE will be supported by the Centre for Workforce Intelligence and will work closely with Health Innovation and Education Clusters (HIECs). In areas of its work and advice where a UK-wide perspective is needed, the devolved administrations may provide this via the UK Scrutiny Group (which is attended by the UK Chief Medical Officers). www.mee.nhs.uk