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Time to reflect

Pharma's relationship with key opinion leaders continues to court controversy. The question is how much of this criticism is justified and what can be done?

I like a conspiracy theory as much as the next man, but some of the stories we hear about how the pharmaceutical industry is 'buying' opinion leaders to endorse worthless or dangerous drugs are worrying. It begs the question: is the industry squeaky clean or is some of the criticism valid?

Balanced criticism will always have a place, either because the industry needs to change the way it works or because the lack of transparency about how it works encourages a negative interpretation. Does that mean that the relationship is inherently unethical? No of course not. Such criticism can be useful in keeping companies focused on working to their highest possible standards.

But how can industry ensure its opinion leader development activities are ethical and seen to be so?

The debate about the ethics of the relationship between the pharmaceutical industry and medical opinion leaders is ongoing. In the media this is largely a one-sided commentary by those critical of the relationship, but the scale of the debate is even greater within the industry, where companies must try to reach consensus on what an appropriate relationship with medical opinion leaders actually involves.

In the UK, this debate was given impetus by the publication last year of the Health Select Committee report on the influence of the pharmaceutical industry. The report concluded that a number of practices have developed which act against the public interest and that 'at the heart of the problem may be the trend for the industry to become ever more driven by its marketing force'. It cited the industry's recruiting of 'key opinion leaders' as one of the problems.

Even Sir Richard Sykes, former chairman of GlaxoSmithKline, was quoted as saying: Today the industry has got a very bad name. That is very unfortunate for an industry that we should look up to and believe in, and that we should be supporting. I think there have to be some big changes.

~

How bad is the problem? People outside the industry could be forgiven for thinking it is widespread. In the US, for example, there have been a number of high-profile court cases into industry promotion. These include that of TAP Pharmaceuticals and its promotion of Lupron, in which it was alleged the company provided kickbacks and bribes to doctors in the guise of, among other things, consulting fees and educational grants. This case resulted in an $875m (?446.3m) settlement.

Often, however, critics of the industry take a few examples of so-called unethical behaviour and, on the basis of these, conclude that this is the norm. In reality, extreme examples of abuse of the relationship are rare. What does happen is that well-meaning people within the industry either get it wrong unthinkingly, or are perceived to be doing the wrong thing.

The case of Cancer United
This has been the case with company sponsorship of charities. Late last year, there was much criticism of Roche's funding of a new charity, Cancer United. The critics implied that it was simply a Herceptin marketing exercise. The Chair of the new charity, a respected academic oncologist, claimed that the charity's campaign for a debate on cancer care standards was his idea and was perfectly proper. We'll probably never know the dynamics that led to the setting up of the charity but it is easy to see how Roche would conclude that there was a good fit between the public interest and its own marketing aims for Herceptin, and that support of Cancer United was perfectly legitimate.

Sponsorship of medical charities, even sole sponsorship initially, is not really a problem and need not have been in this case. Almost all of the criticisms amounted to the same issue - a lack of transparency about Roche's involvement in general, and its funding in particular.

One of the keys to getting opinion leader development right, and to offsetting much of the criticism levelled at the practice, has to be greater transparency.

~

The controversy of ghostwriting
The industry should look at some of its practices, however. An obvious example, and one that has drawn a lot of criticism - much of it justified - is ghostwriting. I know at least one opinion leader who has most of his articles ghostwritten.

He explains that he uses the same writer who knows his style; briefs her on what he wants to say; she then writes the article and submits it to him for his approval. That would seem a perfectly acceptable example of ghostwriting. Is it so wrong if a pharmaceutical company or its agency offers this service to an opinion leader who has agreed to write a review on a product or a disease? I don't believe so.

However, an article in The Observer newspaper describes how a medical academic was approached by a pharma company that had produced a first draft of a report `based on your published work'. According to The Observer, the article was a 12-page review paper ready to be presented at a forthcoming conference. The doctor's name appeared as the sole author, even though he had never seen a word of it before.

When he suggested changes to make it a less glowing review of the company's drug, he was told he had missed some 'commercially important' points. In the end, the ghostwritten paper appeared at the conference and in a journal in its original form, under another doctor's name.

No evidence has been presented to substantiate the doctor's assertions that 50 per cent of articles on drugs in the major medical journals are not written in a way that the average person would expect them to be... and that most of those are no more than infomercials paid for by drug firms. Nevertheless, many of us will have seen similar, if not quite so extreme, examples of this practice.

Is the relationship corrupting?
An often implied, and sometimes stated, criticism of the pharma/key opinion leader relationship is that opinion leaders are influenced to say positive things about a company's products because they are paid to do so. Are there many environments more cynical, where people are more critical of what they perceive to be faults and errors by their peers, than academia?

The idea that all medical opinion leaders will expose themselves to ridicule by their peers through endorsing products they do not believe in, simply because they are being paid to do so, have been bought a meal in a nice restaurant, or have been flown business class to a conference, is not credible. The simple fact is opinion leaders do not say positive things about a product because they are paid by the drug company to speak about it. They are selected by a drug company to speak about the product because they believe in it and will therefore say positive things about it.

I'm not suggesting that doctors are any less motivated by money than the rest of us. The fact that they are willing to work with a company on its initiatives will often be partly motivated by the money they can earn. I don't see anything wrong in a doctor getting a fair return for giving his time. But that is what is being bought: his time, not his endorsement of a product in which he has no belief.

~

The function of marketing
Given all the criticism, maybe it would be easier not to involve opinion leaders in pharma activitie; after all, the industry has lots of reps; ready access to advertising; and the power of public relations is being recognised more and more.

Yet, as we all know, doctors want to hear about products, not from company personnel, but from experts who can interpret the results and put them into the context of other available drugs. This interpretation by opinion leaders works in a way that benefits both the industry and the patients.

A paper by Majumdar et al reported on the positive influence of local opinion leaders on medical practice. They reported that in their study of prescribing in Edmonton, Canada, only half of eligible patients with heart failure received an ACE-inhibitor despite overwhelming evidence of benefit, and those who were prescribed this treatment were usually given doses below those tested in clinical trials.

Local opinion leaders, they concluded, '... are well-known, respected, and trusted to evaluate medical innovations within the local context. Because they influence patterns of practice in the community, and may accelerate the uptake of knowledge, their participation in any programme of quality improvement is essential'.

A more ethical programme?
What should you do as an individual, and what should your company do to avoid inadvertently falling foul of the line, or being perceived to be doing so?

  • Be open and transparent in your dealings with opinion leaders. If you are using them as speakers or to support other educational or marketing initiatives, make it clear what you want from them. If they choose to declare an interest you should encourage that. If you are sponsoring charities and other organisations again be up front about your support

  • Document your interactions with opinion leaders but choose your words carefully. For example, companies often talk about someone within the company owning the relationship with an opinion leader. They know what they mean but to an outside observer it can imply that the opinion leader is in the pocket of the organisation

  • Increase the number of key opinion leaders you know and especially the number you work with. It is very easy to end up working with a small number of product supporters who you know and trust to do a good job. There are dangers in this for both the company and the opinion leader. If they do a lot of work for you, they may start to be perceived as being too close to your company and may lose their credibility with their peers. You also become vulnerable if you are dependent on only one or two people. You can identify who the international, national and local opinion leaders are through a mapping exercise

  • Pay the going rate for an opinion leader's involvement (but no more). There are frequent references to opinion leaders losing their intellectual independence because they have a financial relationship with the pharmaceutical industry. Pharma can defend itself from this criticism if it is paying doctors a fair level of compensation for the work they do. Set company rates for compensation which are in line with the norm for the industry and go above that only when there are justifiable and exceptional circumstances. Furthermore, document why you have done it

  • Do not do anything that you would be embarrassed to see reported. You should work on the assumption that anything you do and say could end up on the front page of The Sunday Times. You might think it won't happen, and you are probably right. But do you want to take the risk?

  • Just because you are criticised for something it does not mean it is wrong. Be prepared to defend your actions

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

The author
Neil Kendle is managing director of Kendle Healthcare

13th March 2007

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