Sunday, July 6, 2014

And -- The Earlier (VIOXX®) Version -- Which MSD Lost, For Background

Oddly, I had it in mind that I had previously covered this little Vioxx® kerfluffle. But it appears I hadn't, so here is that background -- as a historical reference companion -- to my post of this holiday Sunday morning, over coffee, orange juice and a banana.

Here is the much earlier 2004 CMAJ original -- as a PDF item -- and a bit:

. . . .The debate about the safety of cyclo-oxygenase 2 (COX-2) selective inhibitor drugs reignited in February [2004] when a Spanish court rejected a lawsuit brought by the pharmaceutical company Merck, Sharpe & Dohme (MSD) against the editor and publisher of Spain’s independent drug bulletin, Butlletí Groc. The company sued over a July 2002 article entitled “The so-called advantages of celecoxib and rofecoxib: scientific fraud.” The article drew on previously published commentaries in BMJ (2002;324:1287-8) and The Lancet (2002;360:100-1), which slammed the organization and interpretation of 2 pivotal studies on the safety of rofecoxib (Vioxx) and celecoxib (Celebrex) in comparison with nonselective nonsteroidal antiinflammatory drugs (NSAIDs). . . .

The manufacturer of rofecoxib used Spain’s laws on “rectification” to ask the bulletin to print a retraction it had drafted. When the bulletin’s publisher, the Catalan Institute of Pharmacology, refused, the company took legal action. In February, the Madrid court rejected this demand and ordered MSD to pay court costs. . . .

Suing to stop the sort of debate that plays out on the editors' pages of medical journals -- even ones wrongly-perceived to be of lesser import -- seems like a recipe for disaster. Even if Merck wins -- it loses. The courts of law are no place to work out competing scientific claims, of this sort. That is the province of jousting journal editorial pages. Heh.

In today's case, moreover, Merck appears to try to stop scientific debate -- in the name of protecting commerce. You may well recall that, in the end, Merck withdrew Vioxx. And I suspect, in the end, IMPROVE-IT will look very much like a null result -- making the critical texts of Dr. Alberto Donzelli absolutely libel-proof -- truth being an absolute defense here. So -- the whole episode strikes me as unusually not well-thought through, by MSD Italy. That's my $0.02.

[And now, as a house-keeping matter, I'll move this one under the lead for the day -- as it is historical background primarily.]

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