Over the past few years, Pfizer has probably spent a good deal of money trying to work out whether they could bring low-dose atorvastatin (Lipitor, 10 mg) to market as an over-the-counter treatment for elevated cholesterol here in America.
We know that low-dose Lipitor is relatively safe and effective in a significant percentage of patients with elevated low-density lipoprotein cholesterol (LDL-C or “bad” cholesterol) levels … but it doesn’t work well enough for everyone, it does have side effects, and one can’t just take it and assume it is working (even if you know you need it in the first place). So, …
As a part of the development process, the FDA asked Pfizer to implement a trial of whether people could and would follow some pretty straightforward directions associated with the simulated use of OTC Lipitor. Questions asked in the study were:
- Could study subjects follow the direction to check their LDL-C level before starting to take OTC Lipitor?
After starting the use of low-dose OTC Lipitor, could study subjects comply with the direction to check their LDL-C level?
- What proportion of subjects, after checking their LDL-C level, took the appropriate action based on their test results?
- What proportion of subjects already taking an “Ask a doctor or pharmacist before use” medication actually followed the directions and contacted a doctor or pharmacist before using the atorvastatin OTC?
- What proportion of subjects who stopped use of OTC Lipitor actually experienced any of the labeled “Stop use and ask a doctor” symptoms and did actually tell their doctor?
Sadly for Pfizer, we humans failed the test.
Pfizer has not announced exactly how badly we failed the test, but we did fail, and yesterday the company terminated its efforts to bring OTC Lipitor to market in the US when the 1,300-patient study found that subjects couldn’t take the drug correctly without the help of a doctor. Pfizer’s only quoted statement was that
Based on dialogue with the FDA about the program and analysis of this data, the program was terminated.
Another example of how we just have a hard time following the directions … even when they are provided in our own best interests.
If you look at this report on the Bloomberg web site, you get the strong impression that experienced cardiologists were not exactly surprised!