Pfizer Pulls The Plug On OTC Lipitor And It’s The Patients’s Fault

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Many of the drugs that are sold over-the-counter (OTC) began life as prescription medications. Anti-ulcer/heartburn drugs such as the histamine H2 antagonist, Zantac, and the proton-pump inhibitor, Prilosec, were first marketed as prescription only drugs more than 25 years ago, yet now are readily available OTC. The same can be said for anti-allergy medications such as Claritin and Zyrtec, as well as common pain medications such as ibuprofen (the active ingredient in Motrin and Advil) and naproxen (the active ingredient in Aleve). 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. Most OTC drugs, such as pain relievers, heartburn drugs, and anti-allergy agents, all relieve symptoms quickly and patients know right away if the drug is helping them. However, high LDL cholesterol, while harmful over many years, 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.

As part of their recent second quarter 2015 financial results, Pfizer announced the disappointing results of this study:

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.

Perhaps it is not surprising that patients didn’t take personal control of their healthcare as had been hoped. It is apparent that a patient needs to sit down with a physician and be told that he/she needs to get their LDL-C under control with a statin when diet and exercise are not working. Relying on the patient to be motivated to do this on their own is wishful thinking. Also, it is unlikely that this will only be problematic for cholesterol lowering agents. It is hard to envision the FDA approving OTC metformin for treating diabetes or any of the blood-pressure lowering medications that have been used for decades for these same concerns. Furthermore, the FDA struggles with long-time OTC medications like ibuprofen and has recently issued new warnings about the association of OTC anti-inflammatory agents with heart attacks and strokes.

The news that OTC Lipitor is not going to happen will be greeted positively by those who believe that people are over-medicated or those who fundamentally challenge the safety record of statins. However, my guess is that payers will be disappointed by these results as they do not usually cover OTC medications and, despite the fact most statins are now generic, these drugs still impact their bottom-line.

(The author is the former head of R&D for Pfizer, the manufacturer of Lipitor, and still owns Pfizer stock.)

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Source: Forbes