Doctors and the pharmaceutical industry: time for a national policy?

Transparency and open communication are key to a healthy relationship edical 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 processes 1 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, Millar (page 446) 5 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.