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PHARMA: Crestor & Statin slight update.

Light blogging today…as other commitments are banging on the door, however, in relation to a couple of readers comments, I need to say a little more following up on my post on The Lancet vs Crestor issue.

Public Citizen is the most active consumer rights organization in healthcare in the US and Sidney Wolfe and his team have a consistent pattern of identifying problem areas. Public Citizen has a somewhat splotchy record in calling what’s harmful or not in medical care.  It was the driver behind getting silicone breast implants banned, while my reading of the medical evidence is that they weren’t statistically harmful.  However, they often are right and they recently put out a "do not take" advisory on Crestor in their Worst Pills Best Pills newsletter. Their logic was that in the clinical trials Crestor had caused cases of rhabdomyolysis in patients on 80mg doses–this is of course the disease that Baycol caused, even though Baycol never had those results in its clinical trials.  Astra-Zeneca subsequently  lowered the dosage of Crestor available, but I’ve heard an unconfirmed story of two cases of rhabdomyolysis recently appearing among Crestor users. Both cases were outside the U.S. and one patient was using the 40mg dose, the other was being uptitrated from 20mg to 40mg. In other words  very bad side effects may be occurring in smaller doses than were seen as causing rhabdomyolysis in the clinical trials. The Lancet specifically mentioned this risk in its editorial.

I’m in the scientific caboose as regards knowing about whether any of these statin issues are true or not.  My point is not that statins are harmful. While it’s very unlikely that Crestor, Lipitor or Zocor will be pulled from the market, people in the health care mainstream need to realize both that it could happen (and the Lancet article may be a "signal event" in that process) and that the impact of such an event would be huge on the pharma market.

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