Editorials

Conflicts of interest in guideline panel members

BMJ 2011; 343 doi: http://dx.doi.org/10.1136/bmj.d5728 (Published 11 October 2011) Cite this as: BMJ 2011;343:d5728
  1. Edwin A M Gale, emeritus professor of diabetic medicine
  1. 1Diabetes and Metabolism, Learning and Research, Southmead Hospital, Bristol BS10 5NB, UK
  1. edwin.gale{at}bristol.ac.uk

A change in the culture of medicine is needed; legislation is not enough

It has been said that “it is difficult to get a man to understand something when his salary depends upon his not understanding it,”1 and the medical profession has been slow to understand the importance of conflicts of interest. The linked study by Neuman and colleagues (doi:10.1136/bmj.d5621) reports the prevalence of financial conflicts among guideline panel members in the United States and Canada. Of the 14 guidelines considered, six came from government sponsored organisations, six from specialist or professional organisations, and two from private non-profit organisations; three were from Canada and the remainder from the US. Five (four government sponsored) guidelines provided no conflict of interest statement, but their participants had presumably been screened, because only four of 77 panellists seemed to have a conflict. Six of 12 named chairpersons had a conflict, as did 138 of the 211 panellists who provided a disclosure statement; 12 more failed to disclose an interest, and 10 others received research funding from industry. Only 61 (29%) had no potential financial ties.2

The guidelines in question related to the management of diabetes and hyperlipidaemia, therapeutic areas that accounted for sales of $70.8bn (£44.3bn; €50.4bn) worldwide in 2010, or 8.9% of the worldwide drug market.3 Patent protected agents generate most of the profit, but they enter the market in competition with established treatments that are not only cheaper but have more evidence to support their use. Outcome data are rarely available for a new agent at the time of launch, and unexpected safety concerns may still come to light.

Clinical guidelines can bridge this gap, and inclusion has become the passport to marketing success. Guidelines are supposedly evidence based, but the published evidence has usually been provided by the company and is rarely sufficient to fill the evidence gap. The gap is plugged by expert opinion. Evidence based review, in the words of one guideline, “[must] also be supplemented by value judgments, where the benefits of treatment are weighed against risks and costs in a subjective fashion.” 4 Because provisional approval by a panel of experts implies the existence of a body of evidence sufficient to justify the use of the drug, a guideline easily becomes a substitute for the evidence it is supposed to represent and offers a disincentive for the collection of better data. Last but not least, guidelines can have a big financial impact. The committee cited above commented unfavourably on rosiglitazone and wrote 20% off the share price of GlaxoSmithKline in the process.5

With billions of dollars at stake, a company has every motive to encourage potential guideline panellists to view its product in a favourable light, and a virtually limitless budget to support this objective. Established and would be opinion leaders are cultivated with tactics ranging from flattery, career promotion (names on papers is one device), and gifts of money euphemistically described as honorariums. Some of these gifts pass under the table—for example, when an arrangement risks a conflict of interest, companies have offered to transfer the money in ways that cannot be traced.6

Although the proportion of guideline committee members declaring a conflict of interest has risen over time, the proportion of members affected has not changed.2 One suggested remedy is that guideline committees should be composed of only those who have no conflicts of interest. There is a charming sense of unreality about this suggestion—money from drug companies is the oxygen on which the academic medical world depends. The income of the professional societies that publish guidelines largely derives from their annual conferences, which depend on the rents charged to exhibitors and the registration of company sponsored delegates.

Medical journals are not exempt; a past editor of the BMJ wrote that they have become “an extension of the marketing arm of pharmaceutical companies,” while noting that published studies funded by a company are four times more likely to reach a conclusion favourable to the product than those funded independently. Publication of such a trial can earn the journal up to $1m in reprints.7 Professional training and publishing derive financial support from an industry whose influence extends to academic institutions, national representative committees, and the behaviour of politicians. Money from drug companies, and the influence it buys, is integral to the way medicine is done, and the carefully nurtured belief that clinicians can navigate all this amid the odour of sanctity and scientific objectivity is mere illusion.

Let us therefore forget the hand wringing and confront the reality of the world in which we live. Academic and non-academic medicine are pervaded by conflicts of interest, and too many people benefit from the situation for this to be openly acknowledged. How much simpler it is to locate the problem in the conscience of individual clinicians. Meanwhile, and at a time when the US economy staggers under the burden of healthcare, the public purse continues to pour a river of gold into the revenues of the drug industry. Legislation will not change the situation, for the smart money is always one step ahead. What is needed is a change of culture in which serving two masters becomes as socially unacceptable as smoking a cigarette. Until then, the drug industry will continue to model its behaviour on that of its consumers, and we will continue to get the drug industry we deserve.

Notes

Cite this as: BMJ 2011;343:d5728

Footnotes

  • Research, doi:10.1136/bmj.d5621
  • Competing interests: The author has completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declares: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Provenance and peer review: Commissioned; not externally peer reviewed.

References