Pfizer has been running a trial for OTC Lipitor predicated on the willingness and ability of patients to monitor their own low-density lipoprotein cholesterol (LDL-C). The trial failed on the basis of inadequate patient "lab test compliancy" (see: Pfizer Pulls The Plug On OTC Lipitor And It's The Patients' Fault"). Below is an excerpt from the article:
A couple of years ago, Pfizer..., the manufacturer of Lipitor, sought to get FDA approval to run a phase 3 trial that would enable it to convert Lipitor to an OTC medication. Pfizer believed that the dozens of clinical trials involving tens of thousands of patients dosed for multiple years demonstrated sufficient efficacy and safety to justify such a conversion to OTC status. But Pfizer was also banking on the possibility that having the only statin available OTC would rejuvenate sales that were being eroded by low-cost generic versions of Lipitor (atorvastatin) entering the marketplace. To meet the FDA requirements for OTC approval, Pfizer ran a large clinical trial to determine if patients taking OTC Lipitor would get their own blood tests at a pharmacy to see if the drug improved their cholesterol profile. The trial then would determine if patients would indeed make the correct health decisions based on their results...[H]igh LDL cholesterol... is symptomless and the FDA was concerned that patients would either misdiagnosis themselves or not be motivated to get their blood tested in the first place....[Here's part of the recent Pfizer announcement:]
A Phase 3 “actual use” trial intended to simulate the OTC use of Lipitor (atorvastatin calcium) 10 mg was completed in December 2014. 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. Based on dialogue with the FDA about the program and the analysis of this data, the program was terminated.
I think that Pfizer and the FDA were naive in assuming that nearly all patients would be compliant in monitoring their LDL-C "in pharmacies." This is a little confusing since cholesterol testing is not available in pharmacies, at least not now. Perhaps some sort of special arrangement were made for subjects in the trial. However, this raises the very interesting question of the future of point-of-care,"vanilla" testing in neighborhood drug stores. I raised this issue in a recent blog note (see: Theranos Receives CLIA Waver for HSV-1 Test; Prepares for In-Store POCT).
I believe that the future for routine testing lies in their performance in neighborhood drug stores using CLIA-waived POCT analyzers. Such testing will probably be tightly aligned with the in-store, walk-in clinics such as MinuteClinic that will be available in larger stores. However, this linkage is by no means necessary. Such testing will be performed on the basis of a physician lab test order but this will not be mandatory in most states. Test results will be printed for patients or electronically transmitted to hospitals or physician offices on request. The low cost of such testing will surely be covered by most health insurance plans because it will be much cheaper than current testing.
What about the future of OTC drugs that require documentation of lab test monitoring? Simple! Just keep the products behind the counter (see: Why have some over-the-counter drugs moved behind- the-counter?). Patient compliance is enforced at the drug store level. FDA is happy. The pharmaceutical companies are happy. The drug store chains are happy because work is generated for their new POCT operations. Public health officials are happy because cardiovascular disease is controlled. Patients are happy because common lab testing is available around the corner and the more health-focused of them can monitor their own health status. Only LabCorp and Quest are unhappy unless they can come up with an angle to participate in this new approach to lab testing.