Bristol-Myers Squibb (BMS) and Sanofi-Aventis hoped to bolster the case for their blockbuster blood thinner Plavix by demonstrating that using the two drugs together improved results. Instead they ended up showing that aspirin works just about as well as Plavix and is safer. That will be good fodder for the “unsalesmen.”

This isn’t the first time BMS funded a study that ended up making its product look bad. The PROVE-IT study was designed to show that BMS’s Pravachol was better than Pfizer’s Lipitor. Instead it showed the reverse. Here’s what a commentator had to say:

This study [PROVE-IT], like most studies involving statin drugs, was sponsored by a drug company. Often, this fact causes some observers to give less weight to a study’s results than they might otherwise give. However, in the case of PROVE-IT, the sponsor was Bristol-Myers Squibb, the makers of pravastatin – not Pfizer, the makers of atorvastatin. The study was designed to disprove the suggestion some were making that a “stronger” statin would be better for patients than pravastatin. (Indeed, the acronym of the study, PROVE-IT, even suggests the sort of challenge one might hear on the playground.)

Thus, we have here the extremely unusual case of the sponsor’s drug losing out -big time – to the non-sponsor’s drug. This sort of outcome is highly unusual since the sponsors get to approve (or reject) the design of any trial they’re paying for – and thus tend to pay for only trials they believe are likely to vindicate their product. In other words, PROVE-IT wasn’t supposed to turn out this way. If anything, this fact should lend even more credence to the outcome of this study.

BMS sure makes a strong case for aspirin. The “unsalesmen” will have field day with this one.

March 13, 2006

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