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Seeing clearly

Increased scrutiny means that clearly defined procedures and transparency are essential when managing the relationship with opinion leaders

Want to be more successful with your brand throughout its product life cycle? Then pay more attention to optimising your opinion leader development. Opinion leader development has never been under more scrutiny, positive and negative, but even the negative is paying dividends by making us focus more on getting it right.

A number of factors are having an impact on opinion leader development. More people in pharma companies recognise the influence opinion leader activities can have on the success of their brands and opinion leader development as a discipline has matured. As an industry it is also better at it and opinion leaders themselves understand more about how they are perceived by pharma and how to make this relationship work.

The increased scrutiny of the relationship from within the medical profession, and particularly from outside, has had an impact but this is not necessarily a bad thing. The industry has been forced into greater care and transparency in its dealings with opinion leaders. There are increased regulatory constraints such as the EU Clinical Trials Directive and tighter national regulations. Fear of litigation is also a driver, particularly in the US.

This necessitates extra attention to internal processes. Companies need to pay due regard to diverse matters such as consistency in levels of payment for services and the terminology used when recording activities with doctors. They also need to apply greater diligence in complying with increasingly tough regulations.

If the company is implementing a pan-European or global programme, rather than a national one, it becomes even more complicated. Activities that cross national boundaries have to comply not just with the regulations of the country in which they are undertaken but also with those of the country of origin of the opinion leader. That may not be too difficult when it involves one opinion leader but an advisory board of 10 can get complicated, not to mention a database involving doctors from 20 countries.

Is this extra work worth it? I believe that a well-planned, systematic opinion leader programme is one of the most cost-effective activities you can undertake in bringing a product to market. One of the signs that pharma companies agree with this and are taking opinion leader development more seriously - at all levels and across different functions - is the fact that companies are putting formal opinion leader activities in place very early in product development.

The product life cycle
Ideally a product's opinion leader programme should run almost the entire product life cycle from discovery through to maturity. One objection to early involvement is that there will need to be investment in opinion leader involvement in many more drugs, most of which may be regarded as wasted as they will never reach market. However, the level of involvement opinion leaders will have early on will be less comprehensive than when a product is nearing launch. Their advice can make this early stage more efficient and actually save money.

The process should be planned to ensure that the right level of opinion leader support is available when needed. At phase I, for example, this would mean identifying and involving opinion leaders with the right attributes to meet immediate requirements - ie, providing advice on unmet clinical needs and the potential role of the new drug, helping to plan the immediate trials and carrying out the studies. The forward-looking brand team should also be thinking about identifying and developing relationships with the people who have the potential to become the product communicators later on.

Identifying opinion leaders
Most companies now recognise that selecting which doctors to involve - in research, in an advisory capacity, and subsequently in speaking and other marketing activities - has to be done more systematically than in the past. After all, investment in these activities can be enormous and it is essential to ensure that those who are recruited have the necessary experience, expertise and credibility.

The process starts with the identification of the opinion leaders in the relevant therapy area. This should be done systematically by looking at parameters that indicate expertise and/or influence - such as papers published, work cited, membership of committees of medical bodies etc. This process will also identify who has a research interest in specific areas such as epidemiology or quality of life. The analysis can also look at sub-therapy areas of interest. A company with a new product for COPD, for example, may want to know who the opinion leaders are for alpha-1 antitrypsin deficiency, a rare cause of the condition.

The list of opinion leaders should be validated by cross checking their views with those of other opinion leaders in the disease area. Companies can undertake this process themselves, and some do, but most contract out to specialist agencies with more experience. The agency will usually weigh up the parameters to generate an overall rating of influence. Increasing degrees of sophistication can be built in to generate separate lists of the top speakers, most prominent researchers, or those at the cutting edge of trends in the disease area.

Having identified who is out there, the company has to choose which opinion leaders it is going to select to meet its immediate needs and for its longer-term requirements. A mix of people is the best approach. This should include many product advocates of course, but also experts who are not product supporters and who can provide different perspectives - for example, at advisory boards. The company will also want to consider selecting some well known names who will attract audiences by chairing or speaking at meetings - these people may be supportive enough but do not necessarily have to endorse the company's product.

This selection process will also need to take into account the personal attributes and aspirations of each opinion leader. Are they good speakers? Willing to speak to the media? Are they prepared to travel to give talks etc?

Finally, the company will need to consider the mix of specialities and disciplines. In some countries GP opinion leaders are very important in particular therapy areas. In these markets, a GP seeking information may look to a specialist for an opinion on the science of a particular drug but to a fellow GP - with an expertise in the disease area - for endorsement of the use of that drug in primary care.

How many opinion leaders?
How many opinion leaders should a brand team work with closely? There are a number of factors to consider but the main two are how are they going to use them and who is going to manage the relationship.

Marketing departments in most companies, tend to build strong working relationships with too few opinion leaders. This results in the involvement of the same few individuals whom they know really well - for example, as speakers. There is a comfort factor in knowing what a speaker will say and how he or she will answer questions.

The disadvantages of this approach are:

  • Loss of impact of talks - as people hear the same thing several times
  • A danger of loss of credibility for the speaker who may be perceived to be one of the few endorsing this particular drug
  • Few alternatives if the speaker loses his or her enthusiasm for the product because of new data, alternative drugs coming along or unfavourable personal experience

On the other hand, a strong working relationship depends on frequent contact - leading to the development of trust - and enough involvement to satisfy the opinion leader's requirements from the relationship.

In general, to fulfil the global opinion leader function, a company should be looking to build this strong relationship with no more than about 50 experts per brand across clinical and marketing functions. This should be enough to meet the needs for principal investigators on the major studies, advisers, any requirement for speakers and all the other activities that opinion leaders become involved in. At a national level in Europe this figure may be between 10 and 30 depending on the size of the country.

Mutual benefit
One might suppose that opinion leaders may be more reluctant to get involved with the industry because of the adverse publicity. In fact, opinion leaders are much less defensive than the industry about the relationship. They recognise that this is a legitimate, mutually beneficial relationship that works for the medical profession as a whole. Evidence-based medicine has not taken away the need for expert opinion. Having someone with expertise and in-depth knowledge of a drug to put into context the results of studies and clinical experience is essential for medicine to evolve.

It is time the industry got tougher in its defence of this relationship while doing everything possible to ensure the relationship is less open to criticism.

Being seen to be ethical
What can a company do to make sure its opinion leader development programme is, and can be seen to be, ethical? Companies need to be open and transparent in their dealings with opinion leaders. If they are using them as speakers or to support other educational or marketing initiatives, they must make it clear what they require from them.

All interactions with opinion leaders should be documented. Pharma used to be reluctant to be specific about what it wanted from opinion leaders. Undue deference perhaps made the industry vague and ambiguous about what it was expecting from their involvement in marketing activities. Now both sides - especially the opinion leaders - recognise that a formal contract for each activity protects both sides from criticism and gives greater clarity.

Words need to be chosen with care. For example, you may often talk about someone in the company owning the relationship with an opinion leader. Everyone within pharma knows what this means but to an outside observer it can imply that the opinion leader is in the company's pocket.

It is important to increase the number of opinion leaders you are in contact with and those you are working with on each particular project. It is a common mistake to work constantly with a small number of product supporters, tempting as it is to choose those whom you know and trust to do a good job.

It is essential to pay the going rate, but no more, for an opinion leader's involvement. There are frequent criticisms that opinion leaders lose their intellectual independence because of their financial relationships with the pharma.

The industry can defend itself from this criticism if it pays doctors a fair level of compensation for the work they do. Companies should set rates for compensation which are in line with the norm for the industry and go above this level only when there are justifiable exceptional circumstances, all of which should be documented.

One way to ensure that you are acting ethically is to never do anything that you would be embarrassed to see reported. Work on the assumption that anything you do and say could end up on the front page of a national newspaper. It probably won't happen but to envision that it might is a good deterrent.

Remember, however, that just because criticism is levelled at a company does not mean that you have necessarily overstepped the mark. Make sure you are aware of your rights under the law and be prepared to defend your actions.

Have clearly defined procedures in place that stipulate how employees should relate to opinion leaders - and stick to them. These should be developed in conjunction with the company's regulatory people and endorsed by senior management.

Maintaining credibility
A lot is made of the risk of an opinion leader losing his or her credibility through involvement with the industry. In my experience, if it does happen, it tends to be because a doctor is used (and used too often) as an advocate because of their support for a product rather than because they are a true opinion leader. This doesn't often happen with genuine opinion leaders because they understand fully the need to maintain their independence and credibility.

They achieve this, at least in part, by:

  • being scrupulous about declaring conflicts of interest
  • by not devoting too much of their time to industry activities particular things such as speaking
  • working with more than one company.

Pharma needs to recognise that this latter point, in particular, is in the interests of both sides.

Managing opinion leaders
Start your opinion leader development programme as early as is feasible. Discovery or phase I is not too early; but it's never too late to start.

  • plan the process so you know, as well as possible, what your opinion leader needs will be for each phase of the product life cycle
  • systematically identify who the opinion leaders are in your disease area and in any sub-therapy areas in which you are interested
  • select the opinion leaders you choose to work with to give a spread of advisers, principle investigators and product supporters
  • aim for a long-term working relationship
  • work closely with enough opinion leaders to meet your needs but few enough that you can manage them
  • know what each opinion leader is good at and likes to do
  • be clear and specific about what you want from your opinion leaders in general and for specific activities. Ensure transparency by documenting any requirement for specific activities
  • be scrupulously ethical in your dealings with, and deployment of, opinion leaders

The Author
Neil Kendle is the managing director of Kendle Healthcare

19th June 2007

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