Healthy Skepticism Library item: 14099
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Publication type: news
Symons G.
What's on display?
PMLive.com 2008 Aug 8
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=6982
Full text:
A recent article in the British Medical Journal discussing the role of key opinion leaders (KOLs) has sparked vigorous debate on a widespread industry practice. On one hand, some industry executives consider highly paid opinion leaders as little more than product champions – a situation feared by those who wish to defend the integrity of medical professionals and who question the potential conflict of interest between paid advisers and the independence of their opinion. Other industry executives are, however, surprised at the one-sided portrayal of pharma’s interaction with respected opinion leaders and view it as another attack on the maligned reputation of the industry.
It is clear that the current debate polarises opinion, despite the opinion leader argument not being new.
Since the late 1950s, analysts have made significant advances in understanding the role of medical professionals in diffusing medical technology, whether it be drug, device, diagnostic or surgical intervention. The increasing volume of data and the importance of cumulative knowledge means those who can apply abstract knowledge to particular cases are highly esteemed. Little wonder that medical professionals confer opinion leader status on those who have the most robust command of medical knowledge, are up-to-date with technological advances and familiar with the scientific evidence underpinning practice. This expert opinion has currency and opinion leaders are undoubtedly influential at regional, national and international levels.
Since the medical profession is actively engaged in the invention, development, trialling, evaluation, purchase and use of medical technologies, it is not surprising that boundaries between industry and professionals are blurred. For Dr Jon Jureidini, head of the department of psychological medicine at the Womens’ and Childrens’ Hospital in Adelaide, and chairman of Healthy Skepticism – an organisation questioning pharmaceutical marketing practices – these boundaries have been transgressed: “Studies show that KOLs cultivated by the pharmaceutical industry and who have been invited to give talks are likely to be biased. As a doctor, once you acknowledge the duality of interest, you have to disqualify yourself from certain roles.” Dr Jureidini acknowledges that pharmaceutical companies have a specific mandate to make profit and advocates caution with regards to opinion leaders: “There are not that many influential doctors who don’t have financial ties with the pharmaceutical industry and we question putting a good business relationship ahead of patients.”
Is it a business arrangement?
Are opinion leaders simply business partners for the pharmaceutical industry? I put this to Joanne Wunder, business unit head, Ogilvy HealthPR, London.
Her answer was emphatic: “Absolutely not! We don’t consider KOLs to be sales people, nor as extensions to the sales force. Although KOLs may be genuine advocates for a product, these opinions are based on clinical evidence, not on payments by pharma. Judicious use of KOLs is based on their independent, authoritative clinical opinion and pharma would not want to jeopardise their integrity.”
The value of opinion leaders to the industry is largely in their credibility and independence, which can be used to support or oppose technology diffusion. By no means are opinion leaders synonymous with product champions. Outspoken, US-based cardiologist, Dr Steve Nissen, was extremely diligent in highlighting the dangers of COX-2 inhibitors in the face of considerable industry pressure and today holds stratospheric status among peers and regulators. He also commands grudging respect from the industry. Despite the vacuous talk of influence ladders and developing opinion leaders occasionally heard in industry, mavericks such as Dr Nissen demonstrate the cardinal consideration that opinion leaders are nominated by their colleagues, not by industry. Furthermore, research of medical professionals reveals that just having a high media profile has little bearing on peer evaluation as an opinion leader.
Benefit to pharma
What do pharmaceutical firms hope to achieve by engaging opinion leaders? Doctors acknowledge, and industry admits, that the pharmaceutical industry is a commercial profit-making exercise. After passing the safety, efficacy, quality and health economic hurdles, the goal of the industry is to achieve peak sales as quickly as possible to recoup R&D expenses, fund the next cycle of innovation and return remaining profits to shareholders. The technology adoption rate by medical professionals will determine the diffusion curve, and an entire academic literature is devoted to the elucidation of adoption determinants. The historical vagaries of healthcare mean that medical men and women wield inordinate influence; an influence that must be understood and respected, and an influence that is mutable.
A shortlist of activities across the pharma value chain where opinion leaders are sought include clinical trial activities, scientific and marketing advisory boards, working groups, conference talks, educational activities and media relations, to name a few. Based on his experience with industry, Dr Jureidini exhorts: “We have to ask, is it in patients’ best interests?” Dr Jureidini recalls being invited to be chief principal investigator with responsibility to recruit patients for the trial of a new anti-depressant. “I’m not convinced that my intellectual contribution was the larger component of why the company wished to engage me. My view is that I was being cultivated by the company to get me feeling good about the drug.”
However, Gawain Lagnado, associate manager, Bionest Partners (France) reframes the industry-professional dyad: “There is information asymmetry between the industry and their customers. KOLs are an essential conduit and they have an impact on how companies plan their marketing. KOLs have the clearest vision of the market and they are experts with patients – they articulate patients’ needs.” Indeed, if the industry did not communicate with expert opinion leaders, might it be accused of hubris for developing products without consulting the medical profession? Dr Richard Tiner, medical director, The Association of the British Pharmaceutical Industry (ABPI), thinks it would: “Going through development without consulting principal stakeholders would be bizarre, and it would be crass to do so.”
There is no doubt that in the past some pharmaceutical corporate hospitality towards opinion leaders was ethically dubious: sumptuous dinners served in five-star hotels in exotic locations under the banner of advisory boards were simply a job perk. But in the last decade the industry has adhered to an ever more stringent ethical code of practice. Niamh MacMahon, head of communications at the Prescription Medicines Code of Practice Authority (PMCPA), says: “On July 1, we published the updated ABPI Code to reflect the European codes of practice. Advisory boards were already covered under clause 19 of the 2006 Code and we have had very few complaints about them over the last few years. However, the 2008 Code includes a new clause 20, which sets out the rules around the use of consultants more explicity. It requires companies to have a written agreement in place with consultants and encourages them to include in the agreement an obligation for the consultant to declare the consultancy. This is all part of the industry’s drive towards greater transparency.”
Benefit to KOLs
Dr Swapu Banerjee, head of risk management and regulatory practice, PopeWoodhead & Associates (UK) who is involved in setting up independent advisory boards says: “Opinion leaders who review information and give their viewpoints receive a token level of compensation. The company benefits by getting a detached view and, for KOLs, it avoids a possible conflict of interest, as they will not financially benefit whatever their opinion. This contrasts with KOLs who are on long-term in-house consulting arrangements with pharma, where it might be argued that there could be an incentive which may, at least subconsciously, influence the advice given.”
Much has been made of the appropriate level of compensation. Dr Tiner works closely with his counterpart at the British Medical Association (BMA) to negotiate a professional service fee on an annual basis: “The BMA is a trade association and, as such, is not allowed to act as a cartel. It can only suggest a fee, not recommend one, however time taken from practice should be compensated at fair market value.” This may differ from country to country, and from one therapeutic area to another.
Opinion leaders often have ties with a number of pharmaceutical firms as many opinion leaders will not wish to be seen as being tied to one firm or brand. Dr Jureidini, however, is not persuaded that conflict of interest is reduced by sitting on multiple advisory boards. There are other benefits though; it is very much in opinion leaders’ interest to know which technologies will shape their specialty in the future. Although under confidentiality agreements, opinion leaders will have privileged access to clinical data, sales data and other proprietary information.
Conclusion
The industry ought to welcome debate surrounding the use of KOLs. Leading pharma firms will see this issue as an opportunity to promote a transparent policy with regard to opinion leaders and gain competitive advantage; ethical choices are also profitable. Opinion leaders also have a role to play. Dr Tiner encourages KOLs to declare interests up-front and states they should be free to express opinion and talk about other products, including where they see new therapies fitting in. Regardless, both KOLs and industry may wish to consider Tolstoy’s comment in War and Peace that “influence in the world, however, is a capital which has to be used with economy if it is to last.”
The Author
Gerhard Symons is a doctoral researcher at the Centre for Health Management, Tanaka Business School, Imperial College London
Date published: 08/08/2008
