From the European Society of Cardiology Congress: a presentation of the results of an almost eight-year long observational study of 4.77 million patients in Great Britain’s THIN (The Health Improvement Network) database. The study examined patients who had been taking Lipitor™ (atorvastatin) and switched to simvastatin, another lipid-lowering drug. The result: a 36 percent increase in major cardiovascular events (heart attack, stroke, or coronary revascularization).

So, why are patients jeopardizing their health by switching from one lipid-lowering drug to another? The likely answer: They’re not, but the British government is.

Pfizer’s Lipitor™ (atorvastatin) and Merck’s Zocor™ (simvastatin) had long contended for the crown of lipid-lowering agents (statins), and a vigorous literature debated their relative therapeutic and cost effectiveness. However, in the last few years, Zocor™ has lost its patents in developed countries. Now that generic simvastatin is available for a fraction of the cost of branded Zocor™, the budgetary playing field is heavily tilted in favor of the former, and payers are tempted to influence doctors to switch patients from Lipitor™. The British NHS is a leader in this movement (see references cited in the poster).

Obviously, Pfizer seeks to discourage this: Lipitor™ is the biggest selling drug in the world: $11.7 billion last year (at retail prices), but sales declined 2 percent in the first half of 2007, and the company appears to be increasing rebates. So, it’s no surprise that Pfizer has sponsored and conducted this study. Nevertheless, the method and conclusions are scholarly, and pending publication in the British Journal of Cardiology, so this new research inspires caution.

As an educated layman, my takeaway from reading the poster and Pfizer press release is that it’s not clear why 36 percent more of the “switchers” had major cardiovascular events (heart attack, stroke, or coronary revascularization): maybe it was the different meds, or maybe it was because more “switchers” quit taking their pills. Indeed, the cholesterol levels look to have dropped about the same in both groups.

Nevertheless, it brings into serious question the notion that payers should influence doctors to switch patients from Lipitor™ to simvastatin to save money, like was reported in Boston recently. Furthermore, it emphasizes the value of manufacturer-sponsored research. If Pfizer had not sponsored this study, who would have? Certainly not NICE (National Institute of Clinical Excellence), Britain’s “testing agency”, which collaborates with the NHS (National Health Service) to decide what treatments to give patients – both backed up by the authority of the Almighty State.

The notion of a government agency as arbiter of medicines is coming to America: the House bill to re-authorize SCHIP (state children’s health insurance plans) has $300 million earmarked for a new federal “Center for Comparative Effectiveness”, despite the opaqueness and selective interpretation of government-funded research (as discussed by Scott Gottlieb in the Wall Street Journal on August 30).

Today, when a U.S. health insurer pays doctors $100 to switch patients from Lipitor™ to simvastatin, it’s a scandal on the evening news. In a few years, if Congress creates a “Center for Comparative Effectiveness”, it might be mandatory.