March 2, 2014 3:10 p.m. ET
Pfizer Inc. PFE -0.37% Pfizer Inc. U.S.: NYSE $32.11 -0.12 -0.37% Feb. 28, 2014 4:00 pm Volume (Delayed 15m) : 27.11M AFTER HOURS $32.10 -0.01 -0.03% Feb. 28, 2014 6:44 pm Volume (Delayed 15m): 403,664 P/E Ratio 18.88 Market Cap $208.11 Billion Dividend Yield 3.24% Rev. per Employee $563,760 03/02/14 Lipitor: Pfizer Pushes to Sell... 02/21/14 Pfizer Will Resume Shipping Th... 02/19/14 Pfizer Government Investigatio... More quote details and news » PFE in 
Your Value Your Change Short position is forging ahead in its quest to sell an over-the-counter version of blockbuster cholesterol pill Lipitor, hoping to overcome skepticism that consumers can take the drug appropriately without doctor guidance.
New uncertainty surrounds Pfizer's prospects because of recent changes in clinical guidelines for treating people with cholesterol-lowering statin drugs such as Lipitor. The recommendations eschew familiar and relatively easy-to-understand targets for cholesterol levels in favor of a more complex assessment of health factors.
A co-author of the guidelines says they don't support the use of a statin without the participation of a physician. But some doctors and pharmacists say an over-the-counter statin could still be useful.
Pfizer recently started a 1,200-patient clinical trial to test if consumers taking a nonprescription Lipitor get their own blood tests to see if the medicine is improving their cholesterol and then make the right decisions based on the results. Lipitor and its generic equivalents currently are available only with a prescription. Doctors typically order blood tests to monitor cholesterol levels, and watch for side effects such as muscle weakness.
The trial, which is recruiting patients through more than 35 U.S. pharmacies, is expected to be completed by year-end. The results will determine whether Pfizer applies for U.S. regulatory approval. If approved, it would become the first over-the-counter version of a statin.
Over-the-counter Lipitor could be a boon to Pfizer by helping recapture a portion of the market it has lost since low-cost generic versions hit the market beginning in late 2011. Pfizer's Lipitor sales tumbled to $2.3 billion last year from a peak of nearly $13 billion in 2006. Goldman Sachs estimates that over-the-counter Lipitor could generate more than $1 billion in annual sales.
Pfizer Chief Executive Ian Read says the company is putting significant resources behind its over-the-counter effort and that the start of the clinical trial was "an important milestone."
The New York company hasn't disclosed how much it would charge for the drug. Manufacturers make generic versions that sell for 50 cents to $5 a pill.
Pfizer says an over-the-counter Lipitor would help close a "treatment gap" for people at risk of heart attacks and strokes who don't currently take a statin. The company also says the drug could generate savings for the health-care system by getting more people on treatment, possibly warding off costly health problems down the line.
"The OTC status is another access point," says Mark Gelbert, a senior vice president of global research and development with Pfizer's consumer health-care unit. "It's our responsibility to demonstrate patients can safely and effectively use these products."
But there are long-standing and newer potential obstacles for an over-the-counter Lipitor. The U.S. Food and Drug Administration rejected proposals by Merck & Co. MRK +0.58% Merck & Co. Inc. U.S.: NYSE $56.99 +0.33 +0.58% Feb. 28, 2014 4:02 pm Volume (Delayed 15m) : 11.71M AFTER HOURS $56.95 -0.04 -0.07% Feb. 28, 2014 7:56 pm Volume (Delayed 15m): 174,085 P/E Ratio 38.86 Market Cap $166.52 Billion Dividend Yield 3.09% Rev. per Employee $530,518 02/28/14 Merck: DOJ Ends Bribery Probe 02/21/14 People Moves: Morrison & Foers... 02/12/14 Merck's Sale of Consumer Busin... More quote details and news » MRK in Your Value Your Change Short position to sell an OTC version of the statin Mevacor, amid doubts that consumers could correctly choose to take a statin on their own or sufficiently monitor themselves for changes in cholesterol levels and side effects.
Pfizer says it hopes to persuade regulators to approve OTC Lipitor by using "new and creative ways" to communicate instructions for use. Pfizer declines to specify how its approach would differ from Merck's.
How the new treatment guidelines could affect the product's prospects is unclear. The updated recommendations, unveiled last fall by a panel formed by the American Heart Association and the American College of Cardiology, could more than double the number of people who qualify for statin therapy. But by scrapping long-standing recommendations that bad cholesterol levels be reduced to specific targets—say, 100 milligrams a deciliter—the guidelines arguably make the decision to take statins more complicated.
The guidelines use a combination of risk factors to identify certain groups of people who would benefit from taking a statin, such as people who have had a heart attack.
A co-author of the guidelines, Neil Stone, says they don't support the use of OTC statins. "The new guidelines insist on a patient-clinician discussion before a statin prescription is written," says Dr. Stone, a cardiologist and professor at Northwestern University's Feinberg School of Medicine. He says doctors can ensure appropriate dosage and discuss healthful lifestyle changes.
Some doctors fear that the availability of an OTC statin would cause consumers to undertreat their cholesterol because the proposed over-the-counter version is the lowest dose of Lipitor, 10 milligrams. Prescription doses go up to 80 milligrams.
"There's a chance that a lot of people would take less than needed," says Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic.
Other doctors say the removal of specific cholesterol targets could make it easier for patients to take an OTC statin. Once patients know they are in a risk group identified by the new guidelines—for which the low-dose level in over-the-counter Lipitor is appropriate—they could buy the product off the shelf and not worry about treating to a specific target.
"On balance, the new guidelines would be a benefit to those who say the drug ought to be OTC," says Doug Campos-Outcalt, chairman of the department of family, community and preventive medicine at the University of Arizona College of Medicine in Phoenix.
In the Pfizer study that was begun in October, participants are given an empty box of the proposed OTC Lipitor at a pharmacy and left alone to read and follow the directions. Pfizer declines to say whether the label addresses the new guidelines, but patients need to know their baseline level of bad cholesterol. If they don't know, some pharmacies will offer in-store blood tests. If consumers decide they meet the criteria for using the product, they can purchase it and enroll in the trial, taking a pill once daily for 26 weeks.
Among other factors, the study will track what percentage of users comply with directions to get cholesterol levels checked again in six weeks, and whether consumers should continue to take the drug if it is working, or consult with a doctor if it isn't.
Write to Peter Loftus at peter.loftus@wsj.com
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