There were several news stories last week that reported that Pfizer had abandoned its efforts to have its Lipitor brand of atorvastatin made available over the counter, without a prescription. I was never a big fan of OTC statins (more on that later) but I was struck by the reason that Pfizer put out: “The study did not meet its primary objectives of demonstrating patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, take appropriate action based on their test results.”
Left unstated (and unclear) in this is exactly what the appropriate action was supposed to be. I guess they were implying that patients were supposed to check how they responded to the drug and then figure out if they should keep taking it, change the dose or seek professional advice about next steps.
Here's the irony with that. The current practice guidelines of the American College of Cardiology and American Heart Association for the management of high cholesterol no longer advise physicians to check how patients respond to statin therapy, or to adjust the dose up or down to achieve a “target” LDL-cholesterol level. Instead, they suggest that we assess a patient's overall cardiovascular risk using an online calculator, which includes consideration of the patient's age, blood pressure and other risk factors, and then prescribe moderate or high-dose statin (or no statin) based on the result. No more checking the on-treatment LDL-cholesterol.
So it seems that Pfizer determined that they should not go forward because patients are not capable of doing what doctors are not supposed to do. Makes no sense to me.
Nevertheless, this strikes me as the right decision for the wrong reason. Despite the low toxicity and high therapeutic value of statins, I don't think they should be offered OTC. The analogy with other formerly prescription only medications like H2 blockers or antihistamines is poor. Those drugs are useful for episodic use for symptomatic conditions, not continuous treatment of silent ones. Statins may be more like vitamins, something that (if indicated) should be taken regularly. Given the importance of cholesterol management, I believe that if a patient needs the drug, it should be prescribed at a therapeutic dose (higher than what was going to be offered OTC). If the patient doesn't need the drug, then why take it at all? I also think that the best way to make that determination is in consultation with a physician.
What do you think?
Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital. He then held a number of senior positions at Mount Sinai Medical Center prior to joining North Shore-LIJ. He is married with two daughters and enjoys cars, reading biographies and histories, and following his favorite baseball team, the New York Yankees, when not practicing medicine. This post originally appeared at his blog, Ausculation.