Published January 13, 2015
The government is considering whether a drug for a serious chronic condition — high cholesterol (search) — should sit on drugstore shelves alongside medicines for headaches, allergies and athlete's foot.
Supporters say making a low-dose cholesterol medicine available without a doctor's prescription would help get needed treatment to millions of Americans who are at risk of heart disease.
"There's a huge treatment gap," said Jerry Hansen, vice president of marketing at Johnson & Johnson-Merck Consumer Pharmaceuticals Co., a joint venture that is asking the Food and Drug Administration (search) for permission to sell a low-dose version of Mevacor (search) over the counter.
The drug, he notes, has been on the market for a long time and has proven quite safe.
But opponents say selling directly to the consumer allows patients to skip doctor visits, where they might be told to change their diet and exercise — both crucial in the effort to lower cholesterol.
"This is going to encourage people to take medication rather than alter other parts of their lifestyle," said Dr. Michael Schloss, clinical co-director of the Cholesterol Treatment and Research Center at New York University.
A panel of FDA scientific advisers was considering the request Thursday and Friday. The FDA usually follows the recommendations of its advisers.
The FDA turned down a similar request in 2000. In the years since, the drug companies have tested the idea through consumer surveys, focus groups and mock pharmacies, hoping to prove that average patients can figure out for themselves whether they need the drug at all and, if so, if the nonprescription strength is right for them.
But in documents released ahead of the meeting, the FDA detailed numerous flaws with these studies. For instance, the agency said, a study of how well people could understand the label that would be on the drug found that just 1 percent of people who said they could start using Mevacor "right away" were appropriate candidates for the drug. The other 99 percent did not meet the criteria or had a medical condition that made the drug wrong for them.
The drug is only meant for a slice of the population: men 45 and over and women 55 and older whose LDL — low-density lipoprotein (search), or "bad" cholesterol — count is between 130 and 170. They should also have at least one risk factor for heart disease, such as smoking, high blood pressure, family history of heart disease or an HDL — high-density lipoprotein, or "good" cholesterol — count of less than 40.
Certain patients, such as pregnant women, should not use Mevacor.
Mevacor was the first of the statin drugs, which lower cholesterol by limiting the buildup of artery-clogging fat deposits, reducing the risk of heart attack by about a third. As a group, statins made some $14 billion in the United States alone last year.
Still, less than half the people who could benefit take them. Over-the-counter sales are targeted at those with moderate risk who might benefit from a low-dose version of the pill.
Last year, British health officials approved the world's first nonprescription cholesterol drug, Zocor. Consumers must ask a pharmacist for the drug and answer questions to determine if it is appropriate.
Makers of Mevacor think the time is right for U.S. over-the-counter sales, and some doctors agree.
"There's a tremendous number of patients at risk for coronary disease that we're not able to reach," said Dr. Edgar Lichstein, a cardiologist at Maimonides Medical Center in New York. "We need to figure out different ways to get them this medicine."
The company says it will encourage patients to get their cholesterol checked after they begin treatment, though critics say there's no guarantee patients will do it. The company does not want the FDA to require tests of liver function, despite concerns that the drug can cause inflammation of the liver.
Officials have said they would charge about $1 for each daily 20-milligram pill if the over-the-counter sales are approved. That's less than Merck charges for the prescription version, but consumers who have health insurance would have to pay the whole thing, rather than just a co-payment.
Another drug company, Bristol-Myers Squibb Co., said last month it plans to submit a similar application for over-the-counter sales of a statin called Pravachol, but it has not yet done so.