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FEATURE: Ray Moynihan Key opinion leaders: independent experts or drug representatives in disguise? BMJ 2008; 336: 1402-1403 [Full text]

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The clueless KOL

Adriane Fugh-Berman   (21 June 2008)

Experts and female health

Juan Gérvas   (22 June 2008)

KOLs – Devils or Angels?

R. Hamish McAllister-Williams   (22 June 2008)

Key Opinion Leaders may play either role.

Alexander SD Spiers   (22 June 2008)

Is this Conspiracy?

Josep A. Mungai   (24 June 2008)

Tobacco and pharmaceutical business

Hiroshi Kawane   (24 June 2008)

Re: KOLs – Devils or Angels?

Paula J Whittaker   (24 June 2008)

Re: Re: KOLs – Devils or Angels?

Joseph A Sonnabend   (25 June 2008)

Industry Influences on Key Opinion Leaders and Risks of Undermining Commisssioning Priorities

Su Sethi   (25 June 2008)

Key opinion leaders: the doctors leading double lives

Terri Beswick   (26 June 2008)

The clueless KOL 21 June 2008
Adriane Fugh-Berman, Associate Professor Georgetown University Medical Center, Washington DC,20057 Send response to journal: Re: The clueless KOL	Ray Moynihan and the BMJ should be congratulated for exposing the KOL concept. Outraged KOLs will undoubtedly protest that their opinions are unaffected by industry honoraria and hospitality. In some cases this is true. According to an anonymous industry insider interviewed by a publicly funded project I direct (PharmedOut.org), academic physicians are tracked by industry from early in their careers. Promising young faculty are invited to one-on-one meetings by pharmaceutical company executives, who interview them about their work and opinions over an expensive meal with excellent wine. Each potential recruit is flattered and well-fed. However, only those whose opinions align with marketing messages are taken under a company's wing, to be financially supported, pampered, and admired while being flown around to speak at academic medical centers and medical conferences. Some KOLs are genuinely unaware of the marketing message they are disseminating. A KOL's opinion that a certain disease is underdiagnosed, undertreated, or more serious than commonly believed can align perfectly with a company's marketing goals even if drugs are never mentioned. Pharmaceutical companies seek long-term relationships with the KOLs whom they recruit - or create. Constant support, treats, and the gentlest of suggestions by one's "friends" ensure the continued alignment of a KOL's statements with a company's marketing messages. It is absolutely essential to maintain the illusion of the KOL's independence and integrity. Most "experts" are some company's KOL. Thus are our medical meetings managed to limit discourse to competing profitable therapies, and to overwhelm non-industry-funded voices. Competing interests: Dr. Fugh-Berman has been a paid expert witness on the plaintiff's side in litigation regarding pharmaceutical marketing practices.
Experts and female health 22 June 2008
Juan Gérvas, Rural general practitioner 28730 Buitrago del Lozoya (Madrid) Spain Send response to journal: Re: Experts and female health	Experts are everywhere. Experts in many cases use a double standard, when written in peer review journals (where they obtain their credit) and when talking to physicians (where they "work" for the industry). But the problem is not about drugs, but about life. Experts help in changing the social construction of illness by the corporate construction of disease. Female health is an example. Breast cancer epidemy associated to hormone therapy cannot happen without a previous change about female health and the intervention of experts (1). Now is the time for papillomavirus infection and cervical cancer (2). Changing the understanding of health, illness, disease and prevention starts the business. 1-Sackett DL. The arrogance of preventive medicine. CMAJ. 2002;167:363-4. 2-Gérvas J. Prevention of cervical cancer by the HPV vaccines is not definitive. News 06 June 2008 http://www.healthyskepticism.org/news/2008/June08.htm Competing interests: None declared
KOLs – Devils or Angels? 22 June 2008
R. Hamish McAllister-Williams, Reader in Clinical Psychopharmacology and Hon. Consultant Psychiatrist Newcastle University. Psychiatry, Leazes Wing, RVI, Newcastle upon Tyne, NE1 4LP Send response to journal: Re: KOLs – Devils or Angels?	I am an academic psychopharmacologist and heavily involved in independent continuing professional education (via the British Association for Psychopharmacology - BAP). I am frequently invited by pharmaceutical companies to give talks at sponsored educational meetings across the UK and abroad. In my talks I never solely use a companies slide set, though I do include some supplied data slides if appropriate. In general I do not talk about a single drug but try to put the relevant company’s product in the context of currently available treatments and national guidelines. I’m aware that my talk may alter prescribing practice – indeed I hope it does and that this leads to practice more in line with guidelines and improved patient outcomes. This is my motivation for doing such work. I’m also aware that I am only likely to keep being invited by a particular company to speak if there is synergy between my goals and the company gaining marketing benefits. I do get generous honorariums for these talks which require a great deal of travel and time away from work and home. I have a policy that, in general, honoraria for talks I give during the normal working week get paid into a University account to support my academic activity. I only personally receive some honoraria from talks I do in the evenings and weekends. I am not an employee of any company, on retainer or on any board of directors. Neither I nor any family members hold stock in any pharmaceutical company. All money I receive (either directly or paid into the University) is declared to my University, the Trust where I work, the BAP, in lectures I give and papers I write. Giovanni Fava argues vehemently that key opinion leaders (KOLs) should not be used by industry and if they are these individuals should not be accepted as key experts. However his ire appears to be focused on those who have a long term financial stake in the success of the companies with whom they work. He states that receiving honoraria on “specific occasions would not constitute a substantial conflict”1. On the other side of the argument Chalie Buckwell arguing in favour of KOLs working with industry stresses the importance of transparency2. I am encouraged. I follow the transparency recommendations of Buckwell and I do not transgress the area of real concern of Fava. Is it that I am some sort of angel in a world of self-centred devils? I do not believe so. While I can’t speak for all UK psychopharmacologists I am of the strong opinion that the vast majority act in a manner similar to how I operate – that is certainly how they describe themselves in their declarations of interest. Of course the issue of the relationship between KOLs and industry is an important one. I think that the recommendations of transparency and lack of long term financial links with companies are sound and should be followed. It is the tenor of the accompanying editorial Ray Moynihan writes3 that concerns me. It paints a very negative view of KOLs, compounded by the image on the front cover of the BMJ – a puppet doctor presumably being manipulated by industry. I believe that this is distorting the actual reality of the situation in a sensationalist way that helps neither doctors attending educational meetings nor KOLs. No evidence is presented that supports the impression given that the majority, as opposed to a minority, of KOLs are financially closely involved with industry. Without this KOLs should not all be tarred with the same brush and the hysteria being drummed up is not justified. References 1. Fava GA. Should the drug industry work with key opinion leaders? No. Brit.Med.J. 2008;336:1405. 2. Buckwell C. Should the drug industry work with key opinion leaders? Yes. Brit.Med.J. 2008;336:1404. 3. Moynihan R. Key opinion leaders: independent experts or drug representatives in disguise? Brit.Med.J. 2008;336:1402-3. Competing interests: I have received honoraria from a number of pharmaceutical companies for presentations at educational meetings and attending advisory boards. I have also received support for attending scientific meetings and independent investigator research
Key Opinion Leaders may play either role. 22 June 2008
Alexander SD Spiers, Professor of Medicine (retired). N/A. Send response to journal: Re: Key Opinion Leaders may play either role.	The Key Opinion Leader (KOL) may be an independent expert or a drug company representative in disguise, but not both at once. In the independent expert mode, the KOL should be a genuine expert in the field in question and have carried out valid clinical studies with the drug under discussion. He can accept reimbursement for expenses and a moderate payment for his efforts,but the amounts of reimbursement and of payment should be readily ascertainable. In making a presentation, he should always use the generic name of the drug - pharmaceutical companies hate this but it is essential for sustaining the KOL's independent status. Slides prepared by the drug company should neveer be used. They usually display the company's name and logo and generally refer to the drug by its proprietary name. Such slides are appropriate for use by drug company representatives, but are inappropriate for a scientific presentation. The independent KOL should only quote studies that have good scientific credentials and whenever possible should avoid quoting studies that were financed by the drug company. He must be at liberty to cite comparisons with other drugs and to discuss adverse reactions. He should give an honest evaluation of a drug and must not avoid showing a low level of enthusiasm when that is his assessment of a drug. Of course, our truly independent expert may never be invited to speak again by the drug company, but his professional integrity and his standing with his colleagues are preserved. The drug company representative in disguise is easy to spot. His expenses and remunerations are shamelessly high and he uses proprietary names and drug company slides. Sometimes he praises a mediocre drug to the skies. He is engaged for multiple appearances and is referred to by colleagues as "a traveller for a drug company". Fortunately, I believe that the independent expert is more likely to be hearkened to than the drug rep in disguise. Competing interests: None declared
Is this Conspiracy? 24 June 2008
Josep A. Mungai, Registered Nurse Currently disabled Send response to journal: Re: Is this Conspiracy?	It seems like the article speaks to conspiracy. Are there laws governing this in Britain? Competing interests: None declared
Tobacco and pharmaceutical business 24 June 2008
Hiroshi Kawane, professor Japanese Red Cross Hiroshima College of Nursing, Hatsukaichi City, Hiroshima, 738-0052, Japan Send response to journal: Re: Tobacco and pharmaceutical business	It is a great problem in Japan that the government helps Japan Tobacco, Inc (JT) to promote sales of cigarettes. Although JT, Japan's former monopoly, was privatised in 1985, the ministry of finance still owns 50 percent of the company's stock. JT advanced into pharmaceuticals in 1987 and they are working to foster their pharmaceutical operations as a main pillar of their business in the future[1]. The Smoking Research Foundation was established in 1986, and universities and institutes are easily able to accept laundered tobacco money[2]. JT has also spent a large amount of money on pharmaceutical-related research and development. Key opinion leaders might not be independent from the tobacco company in Japan. References [1]JT delight world. Pharmaceutical Business Web page. http://www.jti.co.jp/JTI_E/outline/pharma1.html. Accessed June 24,2008 [2]Kawane H. Universities and tobacco money. Japan has laundered tobacco money. BMJ 2001;323:869 Competing interests: None declared
Re: KOLs – Devils or Angels? 24 June 2008
Paula J Whittaker, Specialist Registrar Public Health Manchester PCT M21 9WN Send response to journal: Re: Re: KOLs – Devils or Angels?	Well done to Hamish McAllister-Williams for engaging in this debate as someone who is paid to give talks by the pharmaceutical industry. I am surprised though, that having read Ray Moynihan's illuminating article describing how the pharmaceutical industry values opinion leaders such as yourself(1), and Buckwell and Fava's Head To Head(2) that you feel encouraged to continue your current practice. You admit to using company slides and tailoring your talk to suit the company's marketing goals to ensure you are invited back to speak again. You say your motivation for doing such work is to alter practice so that it is more in line with guidelines and improved patient outcomes. Really? So not the money then; you'd happily give these talks for free if it wasn't for all the travelling etc? If your motivation is to improve practice, then there are plenty of opportunities to speak at non- pharmaceutical CPD events and to engage with clinical leads in your field. Building up a network of other experts that you can share views and debate evidence with, and allowing free copying and distribution of your teaching material can help ensure your message is widely heard. You might also find that people give your opinion more weight when it's untarnished by corporate sponsorship. The unbiased opinion of an expert given freely, now that is worth it's weight in gold. (1) Moynihan R. Key opinion leaders independent experts or drug representatives in disguise? BMJ 2008;336:1402-03 (2) Fava GA. Should the drug industry use key opinion leaders? No. BMJ 2008;336:1405 Competing interests: None declared
Re: Re: KOLs – Devils or Angels? 25 June 2008
Joseph A Sonnabend, retired NW8 9UG Send response to journal: Re: Re: Re: KOLs – Devils or Angels?	The influence of KOLs has been particularly felt in the field of HIV medicine. In a field where crucial questions need to be addressed by appropriate clinical trials, instead answers are provided by guidelines committees. Industry then produces KOLs, to bolster the recommendations of these committees. An example of such a question is when, in the course of HIV disease it is best to start antiretroviral therapy. More than 10 years after these agents were introduced we still have no clear answer to this question. We only have the changing opinions of the guidelines committees, opinions legitimized by KOLs in providing industry supported educational activities, activities that can provide CME credits in the US. Although "evidence based" is a phrase much used by KOLs, in HIV medicine at least, their activities can have the effect of stifling efforts to provide reliable evidence, in the assumption that sufficient evidence already exists. The objectivity of guidelines committees' recommendations is already in question because of the industry affiliations of many of their members. One can only wonder how much hands on clinical experience KOLs can actually acquire, as their lectures and other educational activities must occupy much of their time. Then again, maybe their presentations are written for them by their paymasters. Not to mince words, KOLs are marketing agents for the companies that employ them. It is sad, for us as physicians, and for our patients that we have allowed clinical practice to be influenced by sources, whose primary obligation is to their shareholders, not to the health of the public. Competing interests: None declared
Industry Influences on Key Opinion Leaders and Risks of Undermining Commisssioning Priorities 25 June 2008
Su Sethi, consultant in publih health medicine Northwest Specialised Services Commissioning Team, Warrington WA4 6HL Send response to journal: Re: Industry Influences on Key Opinion Leaders and Risks of Undermining Commisssioning Priorities	Key opinion leaders (KOLs) sought by industry are not only targeted for the promotion of new drugs but also technical devices developed for minimally invasive surgical approaches. Our commissioning experience suggests that clinicians are offered training and mentoring by an expert if they can guarantee purchasing in advance of a certain number of interventional devices by their trust or commissioning body. Approaches are then made to commissioners and specialty clinical networks. In national priority areas such as cancer and cardiology some commissioners do accede to persistent clinical demands even though the devices themselves may be at a developmental or evaluation stage. Often training,experience, education and service infrastructure requirements for the new devices are still unclear including the optimum numbers of procedures that should be carried out for the development and maintenance of individual operator and institutional skills. By their acquiescence a few commissioners inadvertently exert indirect pressure on their colleagues in other geographical areas. This is brought to bear by their clinicians and trusts anxious not to lag behind in the race for the latest technological advance. In the unstoppable momentum that develops an evidence based clinically and cost effective commissioning strategy based on an objective critique of the limited evidence and recommendations for further research becomes the casualty. Commissioners are inevitably left to pursue a rear guard damage limitation exercise by constructing retrospective clinical governance controls to supplement the short term outcomes from case series. The losers are inevitably the patients at the receiving end of an intervention with short term outcome data, generally good technical placement results but no information on medium and long term clinical outcomes, quality of life, durability of device and reintervention rates. Another victim is medical science. The phase three trials that are needed will probably not be done or if done will report so late that their results will be meaningless as the technological goalpost will have shifted by that stage. Commissioners must stand firm that only well researched interventions backed up by economic evaluation will be considered for new developments. Also conflicts of interest and financial links with the industry by proposers of new clinical developments must be clarified at the start. Competing interests: None declared
Key opinion leaders: the doctors leading double lives 26 June 2008
Terri Beswick, Communications Officer Health Action International, Overtoom 60/III. 1054 HK. Amsterdam. The Netherlands Send response to journal: Re: Key opinion leaders: the doctors leading double lives	The infiltration of pharmaceutical marketing into the world of healthcare practitioners and medical science has been put front and centre by publications such as the British Medical Journal (BMJ). A number of recent articles in the BMJ have given well-deserved attention to the issue of medicine promotion and the controversial strategies employed by drug companies, and in particular, the use of key opinion leaders (KOLs). The most damaging aspect of the KOL trend is the intrinsic conflict between the interests of pharmaceutical companies’ marketing departments and the interests of patients. As the middle men in this relationship, doctors and medical researchers hold a position of inviolable trust. Treading the fine line between duties to patient health and duties as a KOL for a pharmaceutical company will inevitably place a strain on a physician’s independence. It would be naïve to assume that success as a KOL for the pharmaceutical industry does not divide loyalties between profession and pay cheque. Pharmaceutical companies would not, and could not afford to continue employing experts who failed to achieve their marketing objectives. As a minimum, more stringent transparency regulations for KOLs would provide a clearer picture of the conflicts of interest and allow other doctors and medical scientists to make informed judgments about the credibility of their message. However, transparency is no substitute for independence. Highly paid KOLs in a long-term relationship with a pharmaceutical company are more likely deliver information that has passed through the dubious filter of the company’s marketing department than they are to present reliable comparative data. Clearly, this represents a real obstacle to informed decision-making by patients and doctors alike. The influence wielded by KOLs creates a distorted picture of therapeutic value and worse still, helps to extend the reach of that distortion to those responsible for public health and well-being. To counter the influence of KOLs and measure the real value of a medicine, we need more independent voices to discuss new medicines in context, side-by- side with other available treatments and with the fullest possible appreciation of its benefits and potential risks. A return to independence and integrity must be championed and underpinned by unambiguous regulations to govern interaction between business and medicine. Drawing a line between the market and the research will ensure that the interests of public health trump the interests of the pharmaceutical industry. Competing interests: None declared