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Statins and drug companies-more than meets the eye?

Ami Banerjee
Last edited 2nd February 2011

We have blogged a lot about statins in the past here at Trusttheevidence.net, partly because they are so commonly used and partly because they are so often in research and in the media. Their role in secondary prevention is not in question and they are arguably one of the greatest advances in cardiovascular disease prevention in modern times in this respect. However, for quite a while, the role of statins in primary prevention has been doubtful, and last week a Cochrane review and a related editorial added to the already strong evidence base that if you are at low risk of coronary heart disease or stroke, you probably should not bother with statins.

The WHO’s Bulletin included research this week which showed that high cholesterol is undertreated even when it is diagnosed. “The proportion of undiagnosed individuals was highest in Thailand (78%) and lowest in the United States (16%). Time series estimates showed improved control of high total serum cholesterol over the past two decades in England and the United States.” One reason for these observations may be the fact that many of these patients with high cholesterol had no history of cardiovascular disease, and so the lack of definitive evidence for statins in primary prevention may have led to their omission. Another reason may be that the most aggressive marketing of statins for primary prevention occurred in US and European health systems. The authors of the study called for increased treatment of high cholesterol to stem the world’s cardiovascular epidemic, despite continued doubts about the role of statins in primary prevention. This research received wide media coverage and adds to the confusion in policy around statins for primary prevention

So I am wondering how come all this data and controversy about primary prevention data for statins has tended to appear so late in the patent life of the drugs. Of course, part of the issue is that it takes time to organize trials, and to gather enough data for meta-analyses. However, the entry about statins on Wikipedia made me think:

“To market statins effectively, Merck had to convince the public about the dangers of high cholesterol, and doctors that statins were safe and would extend lives.”

Did you know that “Lipitor” (aka “atorvastatin”), made by the world’s pharmaceutical giant, Pfizer, is the biggest blockbuster drug of all time? If you look at the list of top-selling drugs of all time, simvastatin, rosuvastatin and pravastatin are all high on the list. The problem for big pharma is that the statins are going off patent. Atorvastatin is already off patent in several countries and most of Pfizer’s patents for this drug expire in 2011. This is a big financial problem for Pfizer and other companies, and only yesterday, the close of Pfizer’s main UK base was announced. Drug companies are being forced to change their old research and development paradigms. They are also not going to be able to get away with withholding data or encouraging “off-label” use of their drugs. It is surely possible to develop safe and effective drugs with more openly available information to both clinicians and patients.

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