Millions of Americans take statins to help control their cholesterol and try to stay heart healthy. You just can't count on them to handle that on their own, Pfizer ($PFE) has found. And so the maker of Lipitor, the most successful statin of them all, has given up on its efforts to move the drug to an over-the-counter treatment.
The U.S. drugmaker killed those plans, Bloomberg reports, after a yearlong trial in which it monitored the behavior of 1,300 patients to see if they could be counted on to control their cholesterol on their own, keep it regularly checked and take the appropriate steps if it was high. Pfizer found they couldn't.
"Based on dialogue with the FDA about the program and analysis of this data, the program was terminated," Pfizer told the news service in a statement.
The motivation for Pfizer's effort was understandable. Once the best-selling drug in the world, sales have slid to $2.06 billion last year from more than $10 billion in 2011, the year it lost patent protection. It was estimated OTC sales could put another billion dollars in Lipitor sales into the bank for Pfizer.
The FDA has allowed 8 other prescription drugs to go the OTC route since 2010. But most of those were antacid or allergy drugs like Allegra, Flonase and Nexium, Bloomberg points out, not meds that are designed to help prevent heart attacks and strokes. The FDA turned down an effort by Merck ($MRK) to put its cholesterol-lowering drug Mevacor for sale over the counter back in 2008.
|Cleveland Clinic's Steven Nissen|
Some doctors said it was no surprise that consumers were not that good at taking care of themselves. "It's hard enough for me to teach young physicians in training who to administer statins to, let alone to try to do that for the general public," Steven Nissen, who chairs cardiovascular medicine at the Cleveland Clinic, told Bloomberg. "Self-treatment of something as serious as a lipid disorder is not an appropriate course of action."
The issue is also complicated by changing thoughts about how to best control cholesterol. Last year, the American Heart Association and the American College of Cardiology changed their guidelines for prescribing the cholesterol fighters in a way that puts millions more patients in line for therapy.
While Pfizer may be disappointed, the drug remains a blockbuster and is projected to remain in that territory for some years, Bloomberg points out, with sales of $1.74 billion projected for the drug in 2020.
- read the Bloomberg story