Bad Pharma and the statin wars
It was fun to see the former Pfizer executive, John LaMattina, try to answer the new book of Ben Goldacre, Bad Pharma, a powerful indictment of the pharmaceutical sector, the one in which LaMattina worked. This speech of mine is not the occasion to go into the details of this confrontation, but I would just like to say that I advise representatives of the pharmaceutical industry to think very carefully before taking Goldacre.
What I want to focus on is a statement, accepted by Goldacre and LaMattina, which is simply wrong. LaMattina's recent statement responds to Goldacre's brief statement that in his book he states there has never been a head-to-head clinical study with statins. Both accept this statement as fact.
I think it is very curious that neither Goldacre nor LaMattina remember the PROVE-IT TIMI 22 study published in NEJM in 2004. This study compared the Pravastatin (Pravachol, Bristol Myers Squibb) with Atorvastatin (Lipitor, Pfizer). I'm especially surprised LaMattina doesn't remember this because it turned out to be a huge, unexpected boon for his company, despite the fact that it was sponsored by a competitor.
I don't want to get into all the complex medical and scientific stuff, but the story is fascinating: Pfizer's Lipitor was dominating a surprisingly lucrative statin market with rapid growth, despite the total absence of clinical trials with meaningful results. The success was entirely based on theextremely potent action of atorvastatin in lowering LDL.
Pravastatin, on the other hand, had been tested and demonstrated a benefit to patients in several studies with impressive results, but it was well known that it did not lower LDL as effectively as atorvastatin. Bristol Myers had argued that the study results would pass the surrogate endpoint, and to prove this it funded the TIMI group in the PROVE-IT study.
From a commercial point of view PROVE-IT has proved to be a huge self-inflicted disaster. Instead of demonstrating, as BMS expected and hoped, that pravastatin was as effective as atorvastatin, the study ultimately demonstrated that atorvastatin was superior to pravastatin. Powered by the thrust of the PROVE-IT studio Lipitor has soared to new heights and has become the best-selling drug of all time, while Pravachol was much less successful. In retrospect, BMS took a risk and wasted a lot of time.
I'm not sure how the true story of these drugs, and the PROVE IT study fit into Goldacre's or LaMattina's narrative.
