Neil Kendle

Recently the medical director of one of our clients’ affiliates wouldn’t approve the use of the term ‘opinion leader’ in a letter being sent to an external audience. There is a view within the industry that we should avoid this term. Does it matter if we call them something else? I think it does but avoiding the term is a practice that seems to be gaining some ground.

Why are companies so sensitive to the term? Probably the most important catalyst was the highly influential article “Key opinion leaders: independent experts or drug representatives in disguise?” by Australian journalist, Ray Moynihan, which was published in the BMJ a couple of years ago. This was highly critical of the relationship between the industry and influential doctors and described the term ‘key opinion leader’ as “the somewhat Orwellian term used to describe the senior doctors who help drug companies sell drugs”.

I understand why, in the face of such criticism, companies might question the use of the term. At least one major company prohibits the term and instead uses, I believe, “external medical expert”. Their rationale as I understand it, is that these people bring their advice and expertise to the organisation rather than try to influence others on behalf of the company. That would be fine if that’s really the way we engage with opinion leaders but in fact it’s only part of the story and the risk is that it looks as though we’re trying to hide the true nature of the way we work with opinion leaders. In fact we do involve opinion leaders in talking and writing about products.

Moynihan quotes a US ex-sales rep saying, “there are a lot of physicians who don’t believe what we as drug representatives say. If we have a KOL stand in front of them and say the same thing, they believe it”. Well quite – if they say the same thing.

And that’s why it’s in everyone’s interest that opinion leaders do engage with the industry. Prescribers want to hear about the place of individual drugs but they don’t want to hear about it from the company itself. Rather they want to hear from people with the expertise to assess the product in relation to the alternatives and to give advice on which should be used where. They should be people who are knowledgeable, credible and authoritative and hence influential. This must be a legitimate role and I feel strongly that we should defend this important relationship. I’m concerned that if we try to obfuscate how and why we engage with opinion leaders by calling them something else we give ammunition to our critics. It seems too often we react to criticism by making changes, but just because someone criticises what we do it doesn’t make it wrong.

Neil Kendle, Kendle Healthcare. 14th June 2010. Contact me at neil@kendlehealthcare.com or on 0208 487 3726

I was interviewed last week for a total of two and a half hours over a couple of days by a journalist who is writing a report on transparency and opinion leader activities. Her report is obviously going to be very thorough and it sounds like it will be an interesting and informative read. When it’s published I’ll review it for my blog, copyright permitting, as I think this is an important topic – in fact I’ve given talks several times about transparency and published a number of articles that refer to it.
One of the questions the journalist asked me was whether I think the sort of transparency now mandatory in some US states whereby Pharma companies have to disclose how much they have paid individual doctors will prevail in Europe.
I believe that whilst this won’t be widespread for a while, it is inevitable that it will eventually become standard practice. There is a groundswell of opinion amongst legislators and professional bodies for this to happen.
Some big Pharma companies disclose fees to US physicians or have declared their intention to do so even in those states where it is not mandatory. Merck, Lilly and GSK disclose payments to US physicians who speak on their behalf and I think it would be difficult for them to justify not doing this elsewhere. GSK has, in fact, committed to disclosing this information in both Europe and Asia-Pacific sometime this year. Once they do others will follow suit. In the UK, the Royal College of Physicians working party report “Innovating for Health: Patients, physicians, the pharmaceutical industry and the NHS” published last year also recommended making payments to doctors transparent.
I’m generally in favour of greater transparency – the more we can do to break down the perception that we have something to hide, the better. However, for a doctor the disclosure of payments can lead to difficulties for them with colleagues or other or other audiences. Where such fees have been disclosed in the UK for example, it has led to media criticism of the doctors concerned. It has been reported that in those states in the US where full transparency is mandatory a proportion of opinion leaders has chosen to cease working with industry rather than have their fees disclosed.

Furthermore, many companies are now working to formal or informal caps on the amount of money they will pay any one KOL in a year. What this means is that companies will need more KOLs to undertake the same activity level just at the time when fewer of them are prepared to do it.

This brings me to one of my hobby-horses – the need to defend this relationship and promote its importance. We have failed to convey to journalists, the public, and to many doctors themselves, why this is important and why it benefits everyone. Unless we get this message across there will be further mandatory restrictions some of which may be much less acceptable and difficult to work with. We will have only ourselves to blame.

Neil Kendle, Kendle Healthcare. 25th January 2010. Contact me at neil@kendlehealthcare.com or on 0208 487 3726

Recently, the concept ‘Fair Market Value’ (FMV) has become much more familiar to us all. The US has become subject to very tight regulatory scrutiny, and along with that, compensation to doctors for services provided to Pharma companies has become a sensitive issue. These days, where the US leads on KOL regulations, the rest of us follow. In the UK, the latest ABPI Code of Practice, for the first time, uses the term in relation to the payment of outside consultants.

However, how many of us understand the concept of FMV and, if we don’t, does it matter? For now, and in most circumstances, we can carry on as before. It will be sufficient to use industry benchmarks based on what we are used to paying, and what others in the industry are paying. A straw poll of what your colleagues and your competitors pay will establish the range of fees that would be considered appropriate. However, exceptions are reasonably frequent and an understanding of FMV is necessary to be aware of the potential pitfalls.

The concept of Fair Market Value is pretty new to the Pharma industry so it would not be surprising if it was not generally understood. In Europe at least, I believe that is largely the case. Yet its meaning is pretty specifc and the years of practice in industries other than ours have clarified some of the nuances. A generally accepted definition is: “The price of a service between a willing buyer and willing seller, neither being under any compulsion to buy or sell and both having reasonable knowledge of the relevant facts”. If follows that, to take an extreme example, the FMV for an hour of a film star’s time is much greater than that for an hour of my time, which in turn is greater than that of a shelf stacker at a supermarket. By the same token, FMV for a UK pactice nurse who earns around £20,000 will be different from a newly qualifed consultant earning £75,000 which will be different from an eminent physician who is earning a basic salary of £175,000 plus a substantial merit award of maybe £70,000. FMV also allows a premium for higher fees for higher expertise. What’s more, FMV also takes into account scarcity. If there are, say, 5,000 practice nurses and we need a representative on an advisory board that could be a different FMV than if there were only 10 with expertise in particular theraputic area and we needed 5 of them for an initiative. Therefore the FMV for an eminent opinion leader – taking into account income, expertise and scarcity value – will be substantial and one could make a case for it being more than twice that for a newly qualified consultant and over 10 times that of a practice nurse. Not only is this consistent with the understood meaning of FMV, it also makes sense. The intention is to ensure that the level of remuneration paid is not so high as to compromise a HCP’s independence or give the impression that it might. A fee of £1,000 for participating in an advisory board would be small beer to an international opinion leader but would be sustantial to a practice nurse.

I don’t believe that anyone, even in the US, actually pays an opinion leader 10 times as much as a practice nurse but it is interesting that in the UK, for example, the range of acceptable payments so narrow. What happens on a multidisciplinary board where we have set FMV to be appropriate to eminent doctors? The case for paying nurses or pharmacists a lesser fee is pretty strong but how many of us do so? In contrast in the US a recent survey, Thought Leader Fair-Market Value, identified 17 different payment levels for different categories of HCP from opinion leader through to nurse and dietician.

A further implication is that the figure will vary from country to country – most US physicians, for example, earn more than most of those in Europe – and may vary from speciality to speciality – pediatricians in the US on average earn half that earned by a consultant in invasive cardiology. The annual basic salary for a doctor employed by the Government in India is about 13,000 rupees or just over US$20 per month. An opinion leader with a private practice will earn a lot more, maybe $3,000 per month. However, my approach, and that of most people I know, has been to pay all participants on an international advisory board, with the probable exception of the chairman, the same fee. We could therefore end up with a US physician who earns $500,000 a year being paid $2,000 for attending an advisory board which seems like a reasonable amount to pay, and an Indian doctor who earns £35,000 being paid the same. Would an independent investigation judge that our Indian opinion leader had been paid Fair Market Value? There’s a pretty good chance that it wouldn’t.

A friend of mine used to be a cardiologist in the Czech Republic for which his basic annual salary was 120,000 CZK (approximately 4,620 Euros). However, he tells of being paid 67 000 CZK per patient as principal investigator in a Phase III study. I assume that the level of payment was set with US or Western European cardiologists in mind and that would be considered Fair Market Value in those countries. Should we be paying that in emerging markets?

Finally, over the years I’ve come across opinion leaders who, knowing, say, that they are the only person able to give a presentation on the company’s data at a satellite symposium have demanded a really high fee. One might imagine that the concept of Fair Market Value would put an end to that practice. In fact, the opposite is true. As I have said, FMV takes into account scarcity value and, if they really are the only one, or one of the few people, who can give that talk, their market value increases.
I think FMV generates some intriguing dilemmas.

Neil Kendle, Kendle Healthcare. 26th August 2009. Contact me at neil@kendlehealthcare.com or on 0208 487 3726