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→ Read the letter by Gazarian and Kaye.
→ Read the letter by Vitry and Hurley.
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Letters
In reply: Both Vitry and Hurley and Gazarian and Kaye would have had our consensus group address different or broader issues than safe prescribing and use of COX-2-specific inhibitors (CSIs). Indications for use, leakage and cost effectiveness are important issues, but our goal, clearly stated in our article,1 was different and, we believe, important: if a clinician has decided to use a CSI, what considerations are needed to prescribe the drug safely? Disagreements in reaching consensus were not, as suggested by Gazarian and Kaye, due to confusion about the aim of the exercise, but to differences in interpreting evidence and expressing conclusions in simple and direct terms. It would have been easy to avoid these problems by limiting participants to a small group of like-minded colleagues, but we chose to involve a broad range of people who may represent a more realistic spectrum of attitudes and approaches.
We find Vitry and Hurley gratuitously pejorative in their description of the participants in this exercise. With the exception of two rheumatologists with epidemiological expertise (who did not sign off on the position statement2), all the rheumatologists involved were members of one or both advisory boards. They were a relevant group precisely because this role should involve a responsibility to provide sound advice to the industry paying for it, and equally to the profession, both in the interests of good patient care. "Current financial links" is not the way such a consultancy is usually described. They call the exercise "at best a tight collaboration between some healthcare professionals and drug companies" and "at worst . . . as the 'happy end' of a successful marketing campaign". Given that one of the two pharmaceutical companies involved declined to sign off on the statement, as did two rheumatologists who were advisory board members for the other company, this is a curious outcome of "tight collaboration".
With respect to the relative safety of selective versus non-selective COX inhibitors, our considerations were based on data available from peer-reviewed studies published to the end of May 2001 and available on the United States Food and Drug Administration website, as indicated in the position statement2 and the accompanying article.1 A number of the references quoted by Vitry and Hurley became available after May 2001. Renewed scrutiny and analysis of existing datasets is interesting, but the results are best used to decide whether unresolved issues are of sufficient importance to justify further studies, and how these could be designed to deliver evidence that will convince us all, one way or the other. We made the point at the conclusion of the position statement that this is an evolving field and that conclusions may well change with emerging data.3
We consider the statements made in the considerations article1 represent a fair expression of our assessment of the data available to us. Not everyone in the group agreed. In publishing the position statement with the list of participants who endorsed it and those who did not, and by adding an article on the process we adopted, we hoped to highlight the fact that there are controversies and uncertainties about aspects of CSIs which require careful consideration in clinical use and further high quality data to resolve currently unresolvable issues.
University of New South Wales, Sydney, NSW.
John P Edmonds, MB BS, MA, FRACP, Professor of Rheumatology (and Director of Rheumatology, St George Hospital); Richard O Day, 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).Correspondence: Professor J P Edmonds, St George Hospital, Gray Street, Kogarah, NSW 2217. john.edmondsATunsw.edu.au
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©The Medical Journal of Australia 2002 www.mja.com.au PRINT ISSN: 0025-729X ONLINE ISSN: 1326-5377