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Transparently beneficial?

Published on 02/10/06 at 10:53am

The pharma industry is under greater pressure than ever before to adopt an acceptable and ethical way of doing business, and this is having an effect on every aspect of its operations.

But what critics often forget is that pharma companies are businesses, and in order to deliver real progress in their therapies, they have to find a way of effectively marketing their products to the clinicians and the fund-holders in healthcare systems.

This inevitably requires marketers and healthcare professionals communicating with each other effectively  - and that means the otherwise very distinct worlds of medical/clinical and the commercial must find some common ground.

In short, if breakthrough new drugs are to benefit patients, clinicians have to learn about them and be convinced of their value.

The use of clinical advocates, or key opinion leaders (KOLs) as part of this process is nothing new. Perhaps because their use implies an endorsement of a commercial product, the role of KOLs has been on the receiving end of some harsh criticism in recent years, but there is little doubt that properly used, they represent a beneficial route to improving patient care, which should surely be the aim of everyone involved in healthcare, whether they be clinicians, managers, fund-holders or members of the pharma industry.

In an ideal world, the industry would be able to engage with every GP, specialist or consultant before a new drug is launched.  But in the real world, this is simply not possible, so engaging with leading opinion leaders is a perfectly valid method of communicating new medical developments.

So how do you go about developing a network of KOLs whom you can use to build effective communications? At what stage in the development of a new product should they become involved?

How do you maintain the relationship on an ethical footing, particularly given that you are asking independent and objective clinicians to become essentially commercial advocates for your product?

And what about the future  is the pool of KOLs shrinking as medical advancements become more specialised, and where will the next generation of KOLs come from?

Relationship building

One of the key changes in the use of KOLs has been the methods used in identifying and sourcing them in the first place. Once, a simple trawl through the various medical journals, coupled with occasional networking, would throw up suitable candidates, who would usually be senior specialists based either in academia or in prominent teaching hospitals.

In today's rapidly changing NHS, this is not enough. With a huge range of stakeholders and decision-makers to convince, the range of KOL types has also had to change. Senior specialists are still important, of course, but so might be PCT chiefs, senior nurse prescribers or even well-known media GPs.

This segmentation is increasingly important, according to Alex Monaghan, Managing Director of Medical Action Communications. "Today there are a number of tools which can be used to identify, validate, refine and segment KOLs to optimise the benefit from these relationships.  We have invested a great deal in our analytics capability, and this underpins a number of our client offerings."

Building this kind of targeted relationship is something which needs to be undertaken on an ongoing basis, so that when a specific need arises, the first step is a simple audit of existing KOL relationships; from here, any gaps can form the basis of a wish list of new contacts.

Whether to develop these relationships in-house within the pharma company  enabling the company to establish, maintain and own personal relationships, or to use a professional communications company, which may have existing developed relationships within a particular field, will be a choice based on specific need.

There will be no "one size fits all" solution,  but often a combination of these two approaches, using contacts from both client and agency to form a comprehensive pool of KOLs, can be the best way forward.

"The relationship with KOLs is sometimes best initiated by the pharmaceutical companies themselves, as part of the natural scientific process, often around clinical trials and related activities," says Phil Sheldon, Managing Director of Resolute. "Communications agencies can then work within the developing relationship, providing and co-ordinating opportunities for the KOL to manage the free exchange of scientific information."

Sheldon says that this relationship development should be an ongoing process.  "Working with the KOLs at times when they are not 'on point' (for example doing a presentation at a meeting) can be very beneficial. While speaker training, slide reviews and so on are usually offered at or near the time of an event, the relationship can be strengthened to offer such training at non-crucial times, when it better fits a KOLs schedule.

The early bird

One thing that all the experts seem to agree on is the earlier that KOL involvement begins in the process, the more effective their role. But the fact that their real value doesnt become apparent until the phase IV stage means that many companies are reluctant to get KOLs involved earlier, perhaps fearful that if the product doesn't make it to phase IV, the efforts of building and maintaining the KOL relationship will be wasted,  even jeopardising the relationship for future projects.

MAC's Monaghan argues that starting early holds a number of advantages. "The process of establishing KOL relationships needs to start as early as phase I or II, yet many pharma companies do not start to do this until phase III or IIIb.  The earlier that KOLs are involved with research or clinical trials, the greater the opportunity to establish strong, meaningful relationships.

"There's a pragmatic element to the timing as well: the earlier you start a KOL development programme, the earlier you start to build a profile for your new product among key audiences (prescribers, potential endorsers, etc). In this respect, the KOL process is no different from any other part of marketing; if you can shape the environment in advance of the launch, the launch itself will be both much easier and much more effective."

Keeping it ethical

Early and ongoing involvement means that the KOL will be able to be more honest in their advocacy, based on a greater and deeper knowledge, something which is being called for increasingly, and which is a key part of the ethical dimension.

But, perhaps the biggest threat to the status quo when it comes to the use of KOLs is posed by a growing unease about the perceived cosy relationship between senior clinicians and the industry. Allegations of inappropriate influence are inevitable, given that the industry  seeks to use respected independent clinicians to lend credibility to its new products.

Unease about the situation has led the General Medical Council to put forward a proposed new set of rules, which would require greater openness on the part of the KOLs themselves to declare interests, including declaring payments received from pharma companies. The GMC is collaborating with the ABPI to agree a new set of guidelines, following concerns raised by doctors themselves about the issue.

Several examples of perceived sharp practice have been cited as the reason for the move, including instances of consultants being paid by several drug companies simultaneously to sponsor products.

The new rules are designed to make it clear to audiences, who are often unaware of what payments have been made, which speakers are sponsored, so that they can make up their own minds over whether or not their contributions might be influenced.

The proposals are that anyone contributing to an educational meeting, or who has taken sponsorship money from a pharma company, should be identified at meetings and in all the relevant papers and published proceedings.

"It is normal practice for medical journals to require authors of papers to declare any competing interests," said a GMC spokesman. The practice is often not followed at medical meetings and conferences.

The importance of maintaining credibility

So is this the end for credible KOL contributions? That would be overly alarmist, but certainly more transparency will be forced on the process. This might not be such a bad thing, because if the medical professions current suspicions go unallayed, then a creeping credibility seep could suddenly turn into an avalanche.

Phil Sheldon of Resolute accepts that the new rules are inevitable, but believes that the process has been self-regulating and that doctors are not as naive as the GMC suggests. "The good KOLs are very good at policing the relationship themselves  they are practising physicians, research scientists, etc first, and they work with the pharma companies second.

"While they appreciate the fact that most of the clinical trial work that gets done is privately and not publicly funded, they also know the fine line between open, honest and impartial behaviour and that which is not.

"Also, the good companies do not ask KOLs to endorse a product without strong research that proves safety and efficacy; most pharma companies respect the KOLs reputations and know the importance of open, honest communications."

This is perhaps the nub of the matter. For KOL activity to be useful, it must be credible, and any action which undermines that credibility, even for short-term gain, will have long-lasting and negative effects on the success of future KOL campaigns.

Increasingly, the industry is going to have to rein in its understandable and natural desire for all marketing activity to be promotional, because in this context, it is counter-productive. If you ask KOLs to do something which threatens their independence and damages their reputation, their impact as opinion leaders will be undermined.

That said, the industry is using KOLs to get the message across, so it is entirely appropriate to be explicit about what you are trying to achieve, and to discuss with each KOL what you are hoping to get from them.

If they are uncomfortable with what you are asking them to do, then you must either review your own expectations, or accept that they might not be the right person for the job.  There is a difference between acting ethically and being expected to accept damaging your own commercial interest.

Sheldon is not against further regulation, but argues that industry understanding of the importance of credibility will ultimately lead to both ethical and effective campaigns. "While the code of practice is not inherently a bad thing, the issue of KOL/pharma company relationships has been a struggle for decades now, and it will always be best managed by honest KOLs and honest companies."

The shrinking pool?

So, will increased regulation discourage KOLs from getting involved in the future? Will this, coupled with more specialised medical advances, lead to a shrinking pool of KOLs, each more in demand, yet mindful that they cannot spread themselves too thinly? Where will the KOLs for tomorrows campaigns come from?

Does it matter if the pool is shrinking? asks Medical Action Communications Alex Monaghan. The number of KOLs is unimportant; what is important is to identify the key players, recruit them into a programme which engages them, understand their geographic influence and be able to analyse educational activity using a variety of segmentation criteria, so that you can identify specifically where programmes are effective.

Resolute's Sheldon disputes that the pool is shrinking at all. In fact, over the last decade or so, with the increased globalisation of medicine, clinical research and so on, the pool is growing.  Researchers around the world are better at sharing their trial results and other scientific information than at any time in history.

This sharing increases the knowledge pool, challenges new and critical thinking, stimulates additional research, and, therefore, helps to develop new and globally diverse KOLs.

Forward-thinking companies are now developing relationships with future KOLs, attempting to identify rising stars, and to get alongside them early in their careers. This is, or certainly should be, a key part of any company's KOL database activity

Nurturing tomorrow's KOLs

Identifying these rising stars can be done in a number of ways. Trainee groups in specialist medical societies can be a rich source of specialist registrars, and it is worth considering making educational grants available to them for example, to attend a relevant congress or meeting to enable them to keep pace with medical advances and, of course, to build valuable relationships with them for the future.

This does require a long-term view, because it can be many years before the return is seen on such investments. However, time and effort expended at this stage helps to support their career development, shaping positive relationships for the future, as well as building other relevant skills such as presentation and media capabilities.

Phil Sheldon also points out the value of existing KOLs in bringing through future individuals. The established experts teach, lecture, present and actively work with the 'up and coming' individuals, who, in turn, develop into the next generation of thought leaders.

Although the world in which these stars of the future will be working will look very different from today's, there will always be a role for clinical leaders in helping the industry introduce new therapies and new thinking into healthcare.

For sure, the pressure for greater transparency will continue, and many would argue this might even make the process more effective.

Those pharma companies that recognise the need to change the way they plan and conduct KOL campaigns and understand that it is ultimately about helping clinicians provide the best patient care, will continue to bring about win-win interactions between the industry and the medical profession.

 

The changing face of opinion leaders

Just exactly who are the most influential key opinion leaders in your therapeutic field and in your local territory?  This is the central question for marketers scoping a new market, but its an equally essential question for established products, as no healthcare market ever stands still.

In England, perhaps the most notable instance of this is practice-based commissioning (PBC), which, within the next two years or so, should put GPs in the driving seat, completely transforming the potential of these professionals to influence the country's patient services and dictate where money is to be spent.

A diverse range of companies serve the industry in tracking and understanding such dynamics.

Influencer networks

Among these companies is Dendrite, which specialises in technology and consultancy. The company says spending on its integrated marketing solutions in Europe has risen by 40% over the last 12 months, which it believes reflects the growing industry trend to seek in-depth advice on how to target of prospective prescribers more productively, and ultimately, improve marketing return on investment.

"Pharmaceutical marketers are moving away from the shotgun-like approaches of the past towards far more precise ways of narrow-casting their messages to carefully researched audiences," says Mark Kroes, General Manager, Marketing Solutions for Europe at Dendrite International.

Dendrite says advances in data gathering and analysis now allows more sophisticated profiling of audiences.

High prescribers and high profile key opinion leaders were once the main focus for targeted marketing, but now companies can add to this knowledge based on an individual stakeholders role in an influencer network.

The company also competes in the market to advise pharma on how best to approach target clinicians, based on its knowledge of their individual track records of accepting medical representative visits, special clinical interests, attending seminars and responding to direct mail.

Primary Care KOLs

Binley's is another company working in the field and is currently tracking the formation of the new networks or clusters of GPs who are now pioneering practice based commissioning in England.

Binley's John Chater says these GPs and other primary care health professionals involved are a significant new group of key opinion leaders.

"PBC will redirect resources into those services defined by PBC health professionals. This will have a direct bearing on spending, especially in the areas of services provided under payment by results and prescribing."

He adds that the reforms put GPs in the driving seat of service re-allocation: PCTs will retain responsibility for contracting, but GPs will advise on commissioning earmarked services. This could lead to more creative prescribing arrangements and new commissioning boundaries which may cross current PCT areas.

Binleys is gathering details of PBC groups as they roll-out, but the process is in the early stages, with some PBC clusters not yet having an official address, so knowing the practice details is essential.

PBC will see a significant amount of work and funds shifting into primary care, and could see a shift in the balance of power between GPs and secondary care.

"PBC may have an impact on allocation of payment by results resources, as well as prescribing, which may affect cross-sector provision.

"Influence upon KOLs in secondary care will also be determined by Choose and Book, GPs with a special interest (delivering secondary care services in primary care) and the increasing number of clinics being run from modernised GP premises," says John.

As has always been the case, there is an expectation that lead professionals in both sectors will work more closely together to improve services and deliver efficiencies.

 

Andy Newman is a freelance medical journalist.

He can be contacted at andy@newmanassociates.co.uk

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