Pfizer, close to losing Lipitor patent protection, says it will work on OTC version

Exercising daily and skipping french fries probably would do more to improve the health of human hearts, but that medical discussion took a new turn Tuesday when the pharmaceutical giant Pfizer said in the strongest terms yet that it would try to create an over-the-counter version of its best-selling cholesterol drug, Lipitor.

In the 19 years since Lipitor was approved, more than 17 million Americans have gotten a prescription for it.

But this is about more than medicine. This is also about money - Pfizer sold $2.6 billion worth of Lipitor in the third quarter - and perhaps about power in the health-care marketplace, which often ends up being about money.

"Clearly there is an intent at some point to have an OTC version of Lipitor in the marketplace," Pfizer chief executive officer Ian Read said Tuesday in a conference call with Wall Street analysts. "The brand is strong."

Lipitor is the brand name for a compound called atorvastatin and is in the statin category. The Food and Drug Administration has never approved an over-the-counter statin because of concerns about side effects and patient usage, so it would be 2013 or 2014 before Pfizer could clear that hurdle, if it can at all.

Statins help push cholesterol through the bloodstream so it won't form plaque inside the walls of arteries of the heart. When such plaque bursts through the artery wall or clogs the artery completely, a person has a heart attack or stroke and can die quickly.

In the United States, Lipitor and other statins require a doctor's prescription because possible side effects include muscle aches and liver and kidney problems. Theoretically, such patients benefit from regular visits to a doctor, who can monitor side effects and whether the drug is working.

Over-the-counter products can be bought in a drugstore by anyone - children included - without ever seeing a doctor.

Allergy and pain medications have moved from prescription-only to over-the-counter status, but statins have not succeeded so far.

In studies presented at FDA public hearings, most consumers were unable to properly self-diagnose their cholesterol situation and chose the medication when they didn't need it, according to an FDA spokeswoman.

Yale public-health professor Mary E. Tinetti wrote in the New England Journal of Medicine in 2008 that if one statin wins over-the-counter approval, the process might continue until only a few highly toxic drugs remained under the control of prescribing doctors. "The implications for the FDA, the pharmaceutical industry, the medical community, and (most important) the public are enormous," she wrote.

Penn Medicine cardiologist Nehal Mehta, like many doctors, said properly used, statins are a great tool, but he saw more negatives than positives in an over-the-counter version. Still, he said he didn't worry that it would lessen the role for doctors. With years of warnings about cholesterol dangers, he said, "we've given people ample opportunity to avoid our care and they still find a way to us."

Pfizer, which is based in Manhattan but has a big operation in Collegeville, would be very happy to keep the status quo. The over-the-counter idea stems from Pfizer's losing its exclusive patent on Lipitor on Nov. 30. Generic manufacturers - perhaps including Teva, which has facilities in North Wales - are poised to enter the market.

Pfizer knows its Lipitor profit will plummet, but it is doing all it can to maintain the Lipitor brand for as long as it is profitable. Pfizer has offered $4 co-pay cards and has negotiated better deals with pharmacy benefits managers so those organizations will be more inclined to pay for Lipitor rather than insist a patient use a generic.

Dr. Paul Mather, director of the heart-transplant center at Jefferson University Hospital, is also a fan of properly used statins, but he would argue for people to make other changes.

"If I could wave a magic wand, people would be more aware of their family history and their lifestyle," Mather said. "Exercise more and eat in moderation. If they read your story and it scares them to start focusing on a lifestyle modification, you've done a service."