The road to consensus: considerations for the safe use and prescribing of COX‐2‐specific inhibitors

TO THE EDITOR: Regarding the position statement about COX-2 inhibitors, we agree that openness about all potential conflicts of interest is the least we should expect from guideline developers, but this is not enough. Fifteen (65%) of the 23 members of the Australian COX-2 Specific Inhibitor Prescribing Group (including all eight of the rheumatologists involved) declared current financial links with Pfizer and Merck, Sharp and Dohme, the two drug companies marketing COX-2 inhibitors in Australia.2 The Prescribing Group can be viewed at best as a tight collaboration between some healthcare professionals and drug companies. At worst the statement published in the Journal can be seen as the “happy end” of a successful marketing campaign, which began some years ago with the enrolment of the most influential Australian rheumatologists to the advisory boards of the drug companies.3 Members of the group disregarded the “industry” bias on the basis that “some form of bias is the inevitable consequence of knowledge and involvement”. However, numerous studies have shown that industry-sponsored drug information is characterised by an overemphasis on the benefits of drugs and a minimisation of the risks.4 Full trial results with celecoxib are available on the United States Food and Drug Administration website and had been consulted by the Prescribing Group. These data show that celecoxib is not better than diclofenac (P = 0.414) or ibuprofen (P = 0.64) in terms of ulcer complications, the prespecified primary outcome of the trials. There was also no significant difference between celecoxib and diclofenac for the combined outcome of complicated and benign ulcers (P = 0.296). It has been shown that the results previously presented in JAMA for celecoxib were flawed and had been manipulated. The wide distribution of the JAMA article by the drug company as part of intensive marketing campaigns contributed to huge sales for celecoxib. Sales of celecoxib between August 2000 and June 2002 cost Australian taxpayers more than $288m through the Pharmaceutical Benefits Scheme (PBS), more than five times the cost for all other NSAIDs during the same time frame.8 There is some evidence to show that the PBS blow-out observed after the launch of COX-2 inhibitors is at least partly due to their use outside their approved indications (osteoarthritis and rheumatoid arthritis).9 The Prescribing Group did not give any indication for the use of COX-2 inhibitors and did not consider the cost issue, arguing that “there is little pertinent cost-effectiveness literature in the public domain”. The position statement appeared to be an evidence-based review of the safety of COX-2 inhibitors involving eminent rheumatologists, active members of the PHARM committee and National Prescribing Service staff. We believe, however, that the statement promotes misinformation from the pharmaceutical industry. We invite readers to look at sources of drug information that are truly independent of drug companies, such as the Australian Medicines Handbook (www.amh.net.au), Australian Prescriber (www.australianprescriber.com) and Therapeutic Guidelines (www.tg.com.au).