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LETTERS:
Brian R Budenholzer, G Steven Geis, Muhammad Mamdani, David N Juurlink, Geoffrey M Anderson, Richard R Stover, Peter Jüni, Anne W S Rutjes, and Paul Dieppe
Are selective COX 2 inhibitors superior to traditional NSAIDs?
BMJ 2002; 325: 161 [Full text]
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[Read Rapid Response] Pharmacia's misleading graph
Eddie Vos   (23 July 2002)

Pharmacia's misleading graph 23 July 2002
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Eddie Vos,
maintains site http://www.health-heart.org
Sutton (Qc) Canada J0E 2K0

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Re: Pharmacia's misleading graph

Editor - This is regarding "Pharmacia response to editorial" by G.S. Geis, in defense of their COX-2 inhibitor (ref. 1). Its graph (ref. 2) compares Celecoxib withdrawal due to ulcers with the withdrawal rate of "non-steroidal anti-inflammatory drugs" (NSAID).

The end-date on the graph for NSAID appears to be about 13 days AFTER the end-date for Celecoxib--and it is only then that a P=0.045 advantage for Celecoxib appears when, as measured from the graph, we have about 30 more withdrawals in the NSAID group of nearly 4000 patients (withdrawals about n=~85 vs. ~55 for Celecoxib).

The same graph shows that had Geis taken the end-date for NSAID ~13 days BEFORE rather than AFTER the Celecoxib end-date, only about 6 more NSAIDs patients (n=~61 vs. ~55) would have been withdrawn which, no doubt, would have been far from statistical significance.

The graph (ref. 2) shows that there is a sudden jump of ~7 patients withdrawn from the NSAID group on day 360 and of an additional n=~16 on day 386 while on the final date for Celecoxib, day 373, suddenly n=~13 patients were withdrawn. While the 6 months line is clearly indicated, the dates near the end, days 360, 373 and 386 seem totally arbitrary.

Pharmaceutically interfering with the eicosanoid pathways via COX-2 and other NSAID inhibition is difficult enough without "fuzzy" trial results that use group rather than individual patient withdrawal dates, and that compare different end-dates for the different groups. Frankly, what is now part of the world's largest drug company could have given us clear and honest data instead.

Eddie Vos (no competing interests) http://www.health-heart.org Montreal (Qc) Canada

Ref. 1. Geis GS. Pharmacia's response to editorial. BMJ 2002; 325:162 -3. 20 June)

Ref. 2. http://bmj.com/content/vol325/issue7356/images/large/geis.f1.jpeg