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Reassessing medical communications

Published on 24/02/05 at 12:56pm

It's time to be less defensive about perfectly legitimate medical communications methods providing contentious 'sharp practices' can be consigned to the past.

Consider this: a well-informed body of healthcare professionals, receiving regular, credible and impartial information about advances in medicines, so that patients receive the best care and healthcare organisations achieve the most effective and efficient use of their drug budgets.

It a classic 'win-win' situation. New products are analysed, evaluated and accepted into usage to the benefit of everyone. And that includes pharma which has to make a return on the considerable investment it - and only it - sinks into finding new treatments.

But where does that 'regular, credible and impartial information' come from? Well, given that there is only one source of research, then it follows that there can only be one source of information about the advances made during that research. And therein lies a problem and a problem which has entered the brightest spotlight possible.

Suddenly, in the second half of last year, the question was raised: how can an industry which relies on HCPs embracing its new products be trusted to provide impartial information about the development of those products?

Can the industry really resist the temptation to undermine the objectivity of medical research by manipulating clinical trials data for marketing purposes?

These are not theoretical questions. If regulators agree with the cynics, then the industry faces draconian regulation and a further worsening, if such a thing is possible, of the esteem in which it is held by the world at large. Clearly something must be done, and already a new spirit of openness is emerging. But is it too little, too late?

Medical communications practices criticised

For many years, medical communications, in both its medical education and its public relations' guises, allowed pharmaceutical companies to build up doctors' knowledge and awareness of new products and their indications prior to launch.

And yet over the past year, many of the practices which fall into the area of medical communications have come under sustained criticism from influential people both inside and outside the healthcare world.

According to Peter Dommett, managing director at mXm Medical Communications, because pharma companies are commercial organisations it is understandable that the information they choose to provide may be sceptically received by the public.

"However, it will be through the consistent delivery of important and honest information that the trust of the public will be gained," he says.

The whole discipline requires trust and credibility to operate in any meaningful sense.  Accusations of sharp practices could very soon undo many years of hard work in building up the trust in impartial, quality information, which hopefully exists in the minds of HCPs.

Even communications practices which are perfectly bona fide, such as ghost-writing and disease awareness campaigns, have come under attack, with the detractors pointing at abuses. Alex Monaghan, managing director at Medical Action Communications, says: "Patients should not have to wait until knowledge of a new treatment spreads through the medical community by word of mouth."

A perfect forum for those who feel they have an axe to grind with the way that the industry communicates with its professional customers was created in the second half of 2004, when pharma was thrust into the goldfish bowl that is the Health Select Committee.

Industry insiders who complained about the HSC having the pre-determined agenda of removing self-regulation missed the point: it has provided a focus for dissent and dissatisfaction, but we cannot deny that some considerable unease about a creeping commercialism in what should be the sacrosanct world of clinical science has made the move towards tighter regulation inevitable, and that the HSC is simply a symptom of this malaise.

No-one can second guess what the HSC findings will be, or even if they will have any bearing given the imminence of a general election. But one thing is sure: the industry must put its house in order if it is to see off those who would impose draconian regulation.

Looking at three of the areas - ghostwriting of scientific papers, so-called 'disease mongering' and openness during and after clinical trials - which have come under the most sustained criticism during the past few months, provides insight into how well the pharma industry is doing in changing or 'self-regulating' itself.

The ghostly hand

The role of the ghostwriter is nothing new. The very idea that every single research scientist is an accomplished writer is clearly nonsense.  

It is in everybody's interest - the industry, the doctor and the patient - that clinical data is presented in as clear and unambiguous a way as possible, and that requires writing and editorial skills which may not be at the top of your average research scientist's toolbox. Bringing in someone who can make sense of the raw data and present it concisely, accurately and clearly is an obvious remedy.

So why has the role of the ghostwriter suddenly become a big issue? As with so many aspects of the industry, it is the way that pharma has been so defensive about a perfectly sensible practice, coupled with an unwillingness to acknowledge that it is open to abuse, and thus to take steps to stop that abuse, that has led to a perception that the practice itself is harmful.

There are some important caveats: it's no good results being written up by someone who has not been involved in the process from the beginning, and/or by someone who doesn't fully understand the science.  

The named author has to be involved from the beginning, not just signing off a final draft which may be very different from the start point. ABPI guidelines are clear on this: the material presented must represent the "current view of the author". The ghostwriter must work closely with the author to make sure this is the case.

How should the industry respond to the various accusations that have been made about ghostwriting? Two responses are needed: first, a vigorous defence of the concept of ghostwriting, pointing out the benefits to healthcare professionals and patients of information being presented in a clear and readable manner, and bringing to the critics' attention the raft of guidelines which exist to ensure that ghostwritten medical articles accurately reflect the author's views.

But there also needs to be a recognition that abuses have occurred, and a determination - a very public determination - to make self-regulation work so that those who transgress the guidelines are not allowed to get away with it. This means more discipline, a closer eye on what is happening, and better co-operation with the medical journals.

Only in this way will the industry be able to challenge none other than The Lancet editor Dr Richard Horton's assertion, to the Health Select Committee, that ghostwriting in itself constituted one of "ten especially damaging practices". No one questioned his view. Should we be surprised?

The success of disease awareness campaigns in recent years, many of them making a positive contribution to public health, has been viewed in some quarters with barely disguised horror. Because many of the patient group-managed campaigns have out of necessity been sponsored by pharma companies, the industry detractors have been quick to cry foul and accuse the industry of using patient advocacy groups (PAGs) for their own ends.

Disease mongering

As with many of the criticisms levelled at pharma, there is a germ of truth in this but the situation is far from being the simplistic 'good guys-bad guys' split which would be so simple to deal with.

Nevertheless, criticism has come from high-profile and influential quarters. Even before the first evidence session of the HSC took place, the Royal College of General Practitioners (RCGP) issued a press release entitled RCGP Warns Against Unhealthy Pharmaceutical Industry, which accused the industry of "disease mongering", declaring, "pharmaceutical companies' classification of conditions such as hypertension and depression as abnormal are not in the interests of patients and serve only to reward the industry itself...It is very much in the interest of the pharmaceutical industry to draw a line which includes as large a population as possible within the 'ill' category. After all, the bigger this group is the more drugs they can sell."

But should critics of the industry be surprised if it resorts to disease awareness campaigns, given that it is hamstrung by European law which forbids it from communicating direct with patients? Supporting the communications messages of PAGs and, yes, attempting to influence those messages is one of the few ways in which messages about new and existing therapies can reach the ears of patients.

What should the industry's reaction to this attack be? Once again, it is a question of switching attitude, from apologist to advocate. If communications activity can be seen to be in the public interest (as is the case with the overwhelming majority of disease awareness campaigns), then it must shout about the good it is achieving for public health. And at the same time, it must ensure that it resists the temptation to step over the commercial line into demand-creating through spurious 'patient education' programmes.

MAC's Monaghan believes an integrated approach, where positive messages are communicated across the board from the medical and scientific community to the general public, should be the way forward.

The industry should also be fighting back by pointing out that its work in raising the profile of certain conditions is highlighting areas where greater government provision would be in the public good. Because the HSC is focusing its attention on the pharma industry, pharma should not try to cosy up to the government in response; it will gain more respect if it sticks to its guns in promoting what it thinks is right (provided, of course, that it is prepared to do this).

Clinical reporting

Perhaps the most serious accusation levelled at the beleaguered industry is that it is reluctant to be open about the results of clinical trials, without distorting the data in a way which suits its own marketing needs. You can see why the government, regulators and healthcare professionals all seem to have a measure of cynicism about what should be impartial and honest reporting of science because in the end, clinical decisions are made on the basis of this data.

Pressure to be more open is already forcing change within the industry, but more will be inevitable, and perhaps the industry should be leading the way rather than being seen to be following like sulky teenagers.

This slow pace of change has led to health minister Lord Warner calling on pharma companies to fulfil their agreement to publish its clinical trial data. These are not just empty words; they are backed up by new MHRA regulations, and Lord Warner has hinted that he might wield the stick if the industry doesn't play ball.

"One or two companies have stepped forward, but the rest have not. We want to see faster progress. If we don't see it, I will be inviting senior members of the companies concerned to come and have a friendly discussion." A stern warning indeed.

And the message is getting through. Early in 2005, pharma companies finally agreed to be more open about their clinical trials data, including providing web links to both published trials results and those being conducted (although phase I clinical trials results will be excluded, to protect pharma companies from competition).

The results will appear in a standard, non-promotional summary, including a description of the trial methodology and design, and both safety and efficacy findings.

This is a step forward, because it implies that both successful and unsuccessful trials will be reported. The move has been widely welcomed, with the International Committee of Medical Journal Editors commenting: "Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavourably on a research sponsor products."

Honesty the best policy

The audience for medical communications tends to be well-educated and sophisticated, and therefore pharma companies should have nothing to fear from honest and open communications, even when the message is not 100% rosy.

mXm's Dommett agrees that pharma marketing objectives need to be balanced by the provision of fair and honest comparison with competitor products or alternative treatments, which requires "marketing maturity" from companies.

So why has it taken so long for the industry to be dragged kicking and screaming towards a situation where non-selective communications are at last becoming the norm? Why has it taken the threat of draconian government regulation for pharma to face up to its dreadful reputation for partial and selective and therefore not terribly credible medical communications? Especially when that reputation is for the large part not backed up by reality.

As ever, the industry has been poor at putting over its point of view, whilst detractors have been vocal and effective in sustaining the tired, old 'fat cat' arguments. It's high time the pharma industry started to be more robust in facing down the critics of perfectly legitimate medical communications methods.

But it can only do this if it is equally robust in banishing outdated 'sharp practices' which have undeniably sullied the entire discipline.

At its best, medical communications can ensure that patients receive the best treatment for their conditions, and that the health service achieves the best results for its budgets. Surely these are objectives worth standing up for.

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