Healthy Skepticism Library item: 15517
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Van Der Weyden MB.
Doctors and the pharmaceutical industry: time for a national policy?
MJA 2009 Mar 15; 190:(8): 407-408
http://www.mja.com.au/public/issues/190_08_200409/van10295_fm.html
Full text:
Medical practice these days is influenced to a large extent by clinical practice guidelines. Usually sponsored by professional bodies, these compendia of advice should be produced by groups of experts with broad representation and credibility. These experts are expected to follow clearly defined processes1 to arrive at recommendations that are based on evidence, and which are unadulterated by other influences, such as commercial considerations. Strict adherence to this framework underpins the authority and acceptability of the guideline. But these standards are sometimes not met, and there have been calls for reform to ensure reliability of guidelines, and thereby offer patients protection from treatment based on guidelines whose content may be affected by extraneous influences.2-4
In this issue of the Journal, Millar5 adds to the disquiet regarding guideline formulation with his critique of the Prevention of venous thromboembolism: best practice guidelines for Australia and New Zealand, fourth edition,6 produced by a Working Party of Australian and New Zealand experts. The Guidelines were published in booklet form by a company part-owned by a member of the Working Party, and were supported by a grant from a pharmaceutical company that manufactures enoxaparin, a low molecular weight heparin recommended in the Guidelines for prophylaxis and treatment of venous thromboembolism.
In Australia, the National Health and Medical Research Council (NHMRC) has published criteria for developing guidelines,1 and in doing so has set high standards, including standards for commercial sponsorship. In light of the NHMRC criteria, the overall process involved in the Guidelines can be criticised for the:
• apparent lack of independent peer review, as best exemplified by publication in a recognised medical journal;
• lack of comprehensive declarations of conflicts of interests in a setting where at least a perception of pecuniary interest is possible;
• failure to provide levels of evidence or costing for the recommendations;
• failure to include a full and readily available list of the references on which the evidence for the recommendations are based;
• failure to divulge the precise writing process and the details of the relationships between the publisher, the Working Party in general, and individual Working Party members and the sponsoring pharmaceutical company; and
• publication as a booklet that was initially distributed only by the sponsor, and thus not easily or independently accessible.
Millar’s article implicitly raises the question of tolerance by the medical profession in general of the involvement of the pharmaceutical industry with these and other guidelines. At the core of this issue lie the opposing aims and philosophies of the pharmaceutical industry and medicine – namely that, although both groups ostensibly work for the benefit of patients, the industry does so to make a return on capital, whereas doctors generally do so altruistically. As stated in a recent commentary in JAMA:
By favoring . . . one therapy over another, guidelines often create commercial winners and losers, who cannot be disinterested in the results and who therefore must be separated from the process.2
Nevertheless, it is natural that the pharmaceutical industry has a keen interest in guideline development. Commenting on the interaction of industry and medicine, Sir Iain Chalmers of the James Lind Initiative in the United Kingdom was recently quoted as saying:
I do not blame industry for trying to get away with anything that is normally considered to be its primary purpose, which is to make profits and look after its stakeholders’ interests.7
Sponsorship and marketing behaviour is not unlawful (nor should it be), and indeed is at the centre of company philosophy and statute in a capitalist economy. Therefore, the restraint on unbridled marketing effort that can compromise patient care lies squarely with the medical profession. The profession’s individual members are obliged to maintain a respectful distance from the pharmaceutical industry and show some disdain for the apparent benefits of pharmaceutical sponsorship – to avoid being stabbed, one should not waltz too closely with the porcupines! Two senior editors of JAMA recently wrote:
The profession of medicine, in every aspect – clinical, education, and research – has been inundated with profound influence from the pharmaceutical and medical device industries. This has occurred because physicians have allowed it to happen, and it is time to stop.9
In Australia, there is no overarching national policy for interactions of Australian doctors and the pharmaceutical industry. We should consider the lead of our colleagues in the UK, where the Royal College of Physicians of London (RCP) recently published a report entitled Innovating for health: patients, physicians, the pharmaceutical industry and the NHS, which extensively defines a framework for proper interaction.10 The Royal Australasian College of Physicians has also commented on this topic.11 There have also been recent multinational calls for the cessation of industry support for continuous medical education directed to individual doctors and institutions.10,12-14 However, the President of the RCP counsels that there is no need to destroy the bridges between industry and the profession. What is required is that the culture between these sectors should be transparent, and governed by open communication and agreed-upon national policy.15 This is sound wisdom to guide national policy deliberations in Australia.
