Healthy Skepticism Library item: 1920

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

Vitry AI, Hurley E.
The road to consensus: considerations for the safe use and prescribing of COX-2-specific inhibitors.
Med J Aust 2002 Nov 18; 177:(10):572-3
http://www.mja.com.au/public/issues/177_10_181102/vitry_181102.html

Abstract:

Openness by guideline developers about potential conflicts of interest is not enough. 65% of the members of the Australian COX-2 Specific Inhibitor Prescribing Group declared current financial links with Pfizer and Merck, Sharp and Dohme, the two companies marketing COX-2 inhibitors in Australia. The Prescribing Group can be viewed at best as a tight collaboration between healthcare professionals and drug companies. At worst their statement can be seen as the ‘happy end’ of a successful marketing campaign. Members of the group disregarded the industry bias on the basis that some form of bias is inevitable. However, numerous studies have shown that industry-sponsored drug information overemphasises benefits of drugs and minimises risks. Data on the US FDA website show that celecoxib is not better than diclofenac or ibuprofen 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. Results previously published in JAMA for celecoxib were flawed and had been manipulated. The wide distribution of the JAMA article as part of intensive marketing campaigns contributed to huge sales for celecoxib. Between August 2000 and June 2002, celecoxib cost Australian taxpayers more than A$288 m through the Pharmaceutical Benefits Scheme (PBS), more than five times the cost for all other NSAIDs. The PBS blow-out observed after the launch of COX-2 inhibitors is at least partly due to their use outside their approved indications. The Prescribing Group did not give any indication for use and did not consider cost. The position statement appeared to be an evidence-based review, but it 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).

Keywords:
Bias (Epidemiology) Conflict of Interest* Consensus Cyclooxygenase Inhibitors/adverse effects Cyclooxygenase Inhibitors/therapeutic use* Drug Industry* Drug Utilization Review Evidence-Based Medicine Humans Isoenzymes/antagonists & inhibitors* Practice Guidelines/standards* Prescriptions, Drug/standards* Prostaglandin-Endoperoxide Synthase Safety