332 MJA Vol 176 1 April 2002 EVIDENCE-BASED MEDICINE The Medical Journal of Australia ISSN: 0025-729X 1 April 2002 176 7 332-334 ©The Medical Journal of Australia 2001 www.mja.com.au EVIDENCE-BASED MEDICINE THE ACCOMPANYING ARTICLE (“Considerations for the safe prescribing and use of COX-2-specific inhibitors” — page 328) 1 is the outcome of an attempt by a group of clinicians and other health professionals to arrive at a concise consensus statement on the safe use and prescribing of COX-2-specific inhibitors (CSIs), based on an assess- ment of the published literature on the CSIs currently available in Australia. The initiative arose out of concern among rheumatologists on advisory boards to pharmaceuti- cal companies that these drugs not be perceived as “NSAIDs [non-steroidal anti-inflammatory drugs] without side- effects”, but be used with appropriate care and caution. Further, there appeared to be some confusion about the merits of these drugs relative to each other and to conventional NSAIDs. As we believe that aspects of the process undertaken by the Australian COX-2-Specific Inhibitor Prescribing Group have a bearing on evidence-based summaries and the consensus process in general, we describe that process here. The process As the formulation of precise indications for the use of NSAIDs rather than CSIs (or vice versa) would generate interminable controversy, we agreed to confine ourselves to the apparently simpler topic of safe CSI use. Nonetheless, the process of reaching consensus proved difficult, the more so as summary statements were simplified. Membership of the working group Membership of the group was the first point of debate — and dissent. It was proposed that the group would comprise the rheumatology members of the two pharmaceutical advisory boards (Pharmacia/Pfizer and Merck, Sharp & Dohm), representatives from the medical and economic departments of the pharmaceutical companies, general practitioners, gastroenterologists, nephrologists and cardiol- ogists, rheumatologists with expertise in clinical epidemiol- ogy and representatives of the Arthritis Foundation of Australia (AFA), the Australian Rheumatology Association (ARA), and the National Prescribing Service (NPS). This arbitrary membership initially raised no concerns. Later, some participants noted that opinions expressed in some sections of the article may have been different had there been broader representation in the non-rheumatological specialist areas. Others questioned whether a consensus process, claiming to be evidence-based, should involve people with potentially conflicting commercial interests (such as advi- sory board members), although, in such an event, just who would have undertaken the task is not clear. Not surprisingly, the main point of contention from the outset was the inclusion of the medical and economic representa- tives of the pharmaceutical companies. Indeed, some people declined the invitation to join the group, as they considered such heterogeneity would prejudice the perception, if not the conduct, of the process. The group as a whole took a contrary view. As some form of bias is the inevitable consequence of knowledge and involvement in any issue, it seemed best to include a broad range of stakeholders, but to strive for transparency by listing the group’s composition and affiliations. The road to consensus: considerations for the safe use and prescribing of COX-2-specific inhibitors John P Edmonds, Richard O Day and James V Bertouch For editorial comment, see page 304; see also page 328 University of NSW, Sydney, NSW. John P Edmonds, MB BS, MA, FRACP, Professor of Rheumatology (and Director of Rheumatology, St George Hospital); Richard O Day, AM, MD, FRACP, Professor of Clinical Pharmacology (and Director of Clinical Pharmacology and Toxicology, St Vincent’s Hospital). Department of Rheumatology, Prince of Wales Hospital, Sydney, NSW. James V Bertouch, MD, FRACP, Chairman (and Chair, Therapeutics Committee, Australian Rheumatology Association). Reprints will not be available from the authors. Correspondence: Professor John P Edmonds, St George Hospital, Gray Street, Kogarah, NSW 2217. john.edmonds@unsw.edu.au ABSTRACT We describe a process which aimed to achieve consensus on evidence-based considerations for the safe prescribing and use of the COX-2-specific inhibitors available in Australia among a group of 31 clinicians and other health professionals, drawn from practice, academia and industry. Difficulties were encountered at several points: ■ the composition of the working group was contentious; ■ the evidence, drawn from large clinical studies, was criticised by some for problems of study design, data analysis and reporting; ■ interpretation of study results was influenced by the interpreter’s knowledge, skills and biases; and ■ the formulation of the “Considerations” became more controversial as summary statements were contracted and simplified. Agreement on the final draft was achieved among 23 of 31 participants. Evidence-based practice guidelines are a welcome development in modern medicine, but the consensus required to produce them can mask important MJA 2002; 176: 332–334 diversity of opinion. EVIDENCE-BASED MEDICINE