OTC Lipitor? Why Pfizer made the right decision for the wrong reason.

There were several news stories recently that reported that Pfizer had abandoned its efforts to have its Lipitor brand of atorvastatin made available over the counter (OTC), without a prescription. I was never a big fan of OTC statins, 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.

Ira Nash is a cardiologist who blogs at Auscultation.

Leave a Comment

Most Popular

KevinMD logo - transparent