For the third time in eight years, Merck goes before an FDA panel this week seeking permission to sell its cholesterol-lowering drug Mevacor over the counter without a prescription. And if the agency agrees, Mevacor would become the first over-the-counter statin, the biggest-selling class of meds, The Star-Ledger of New Jersey notes.

Merck argues that millions of Americans susceptible to heart disease and stroke who aren’t taking a statin could receive health benefits. “Heart disease is the biggest killer in the US, and cholesterol is the biggest risk factor. We know statins are safe and effective, but there are huge treatment gaps,” Jerry Hansen, executive director of Merck Research Labs, tells the paper. “We found consumers in the moderate risk population are motivated and health conscious and know they have high cholesterol and go see a doctor. But people are reluctant to take a prescription because they view themselves as healthy and not sick.”

Having been rejected in 2000 and again in 2005 because of concerns about the need for professional supervision, Merck hopes to persuade the panel on Thursday that the benefits of OTC availability outweigh the risks, and that consumers can be educated regarding proper usage. But Merck’s request has divided the medical community, with a number of well-known experts arguing that cholesterol drugs require blood tests and regular monitoring, and could be misused if not prescribed and supervised by a doctor.

Brian Strom, professor of public health and preventive medicine at the University of Pennsylvania Medical School, says OTC drugs are generally used to treat ailments where the patient can tell if the med is working. And there are currently several low-cost prescription generic statins available, including copycat versions of Mevacor and Zocor, another Merck drug. The only benefit of OTC marketing, he says, goes to drugmakers that want to “make more money.”

“Statins are great drugs and clearly underutilized, and society could benefit from more use of them,” he tells the paper. “But statins don’t fall into the OTC category. They require blood test measurements to know whether they are safe to use them or to know whether you are taking enough.”

R. Gregory Sachs, a cardiologist and former president of the Medical Society of New Jersey, has a different view. He says Mevacor and its generic equivalents have been used safely for years with few permanent or irreversible side effects. They have been proven to have protective effects at the lowest doses and should be made available over-the-counter. Some people may inevitably misuse the med or not get the proper blood tests, but he emphasizes that the benefits of preventing heart attacks and strokes for millions of people far outweigh the possible harm.

“There are a big group of people who may be willing to use it if they feel they are in control of their health and don’t want a doctor or the pharmaceutical industry in control,” says Sachs. “They will feel if it is OTC, it must be darn safe, and they will use it.”

Merck’s pitch, based on a new consumer study and other data, will stress that “once a day OTC Mevacor” is “more than just a pill, it’s a program” that will include patient guidance and offer positive health benefits. The target audience is 14 million men aged 45 and older and women over 55 in the “moderate risk” category who aren’t using statins but have overall high cholesterol between 200 to 240, and LDL or bad cholesterol between 130 and 170. Merck’s Hansen says a 20 milligram dose could help consumers in this group who now take an unproven OTC dietary supplement, rely solely on diet and exercise or do nothing at all.

To Steven Nissen, the chairman of cardiovascular medicine at Cleveland Clinic and outspoken drug safety advocate, Merck’s arguments fall short.

“High cholesterol should be treated carefully based on risk factors and family history. The idea that one size fits all is not the way to administer cholesterol therapy,” he tells the Ledger. “I am concerned a lot of people will take this drug over-the-counter will think they are at risk and they may not be, or people who need intensive cholesterol therapy will end up taking too a low dose and will not reach their cholesterol targets.”

Prescription cholesterol drugs, some now generic, are the most widely prescribed medications in the United States, accounting for $35 billion a year in sales. The top-selling statin, Pfizer’s Lipitor, is the No. 1-selling prescription drug in the world.

Merck, which signed a licensing agreement for Glaxo to market Mevacor, sees an untapped potential on the OTC side, and believes it could open the marketing door for other statins that have lost patent protection. Other widely prescribed statins, including Lipitor, stand to lose patent protection within the next three years. Mevacor, which is infrequently prescribed because it is an older statin, had only $20 million in sales worldwide in 2006.

If Merck gets FDA approval, the company will be given three years of exclusive rights to sell OTC Mevacor even as generic prescription versions remain on the market and are available at stores like Wal-Mart for as little as $4 a prescription. After three years, generic drugmakers would be free to introduce their own versions of OTC Mevacor.

Barbara Ryan, a financial analyst with Deutsche Bank, saysid that as a consumer brand, OTC Mevacor might have sales in the $100 million to $200 million range. FDA approval would help expand Glaxo’s OTC business, which now includes the former prescription diet pill Alli, and would “extend Merck’s languishing franchise” on Mevacor, she tells the paper, but adds that OTC Mevacor would result in only “incremental earnings” for Merck and “will not move the needle for investors.”

“We are taking a wait-and-see approach on whether the FDA feels there is enough information to approve its safety for OTC use,” says Ryan. “It’s hard to predict if the third try will be a charm.”