Is this statin ready for a place over the counter?
Doctors have prescribed statin drugs to millions of people to reduce their cholesterol levels and thus cut the risk of heart attacks. The pharmaceutical company Merck & Co has asked the Food and Drug Administration to let pharmacies sell a lower dose formulation of the company’s statin drug Mevacor, also known as lovastatin, over the counter.
On Thursday, an FDA advisory panel recommended that the agency reject Merck’s third such request. The FDA is expected to make a decision early next year.
Proponents for changing the status of lovastatin, including some physicians and Merck, have pointed to the 14 million Americans at moderate risk of heart attacks due to high cholesterol who aren’t getting treated for it. “Many have had a cholesterol test already, but they feel healthy and they’re not ready for a prescription product,” says Ron Rogers, a spokesman for the Whitehouse Station, N.J.-based Merck. “That is the niche OTC [over-the-counter] Mevacor would fill.”
Opponents, including the American Medical Assn., say an over-the-counter statin is a bad idea because people may use the drug inappropriately and may bypass valuable visits with a physician.
In the United Kingdom, the National Health Service made a different cholesterol-lowering drug, simvastatin, available over the counter in 2004. Not everyone can buy it -- consumers have to have a moderate risk of a heart attack and must purchase it directly from a pharmacist. And, as is proposed for Mevacor, the over-the-counter version is at a lower dose than the one available by prescription.
It’s too early to determine whether this over-the-counter statin has cut the number of heart attacks in the U.K.’s population. But several studies have looked at how pharmacists and patients have reacted to over-the-counter access.
In one study, 1,100 pharmacists responded to a survey in Scotland about their attitudes about selling the over-the-counter statin. At the time of the survey, the drug was not flying off the shelves: Only 200 of the pharmacists had sold it in the prior two weeks.
Even so, the study found that the pharmacists supported selling the medication: 60% felt confident about selling the drug, and 82% thought community pharmacists could assess whether it was appropriate for a consumer to use it. And 94% had kept up on their education about statins.
In another study, Samy Suissa of McGill University in Montreal, Canada, and colleagues determined how over-the-counter sales in the U.K. affected the number of prescription versions sold by examining a database of 3.5 million patients. Before the statin was offered over the counter, prescription sales were rising by 437 prescriptions per 100,000 people every quarter. After the new rules, the rate of filled prescriptions abruptly started to drop, decreasing by 281 prescriptions per 100,000 people every quarter. The findings suggest (but don’t prove) that people were using the lower-dose over-the-counter drug instead of the prescription one.
Suissa says there are still many unknowns about the effects of the change in Britain -- such as whether people are using the drug correctly, if their over-the-counter availability is lowering heart attack mortality and whether people are suffering negative side effects from the drug. (Although generally safe, the use of statins combined with some drugs is associated with rare side effects such as muscle weakness or muscle loss.)
There are some U.S. data on people’s likely reactions to broader statin use. In 2004, Merck tested people’s behavior in a “consumer use” study in which lovastatin was provided over the counter to 3,000 volunteer consumers in several mock drugstores across the country. The study found that one-third of the volunteers bought and used the over-the-counter medication. After 26 weeks, researchers measured the participants’ cholesterol levels. Overall, there was a 20% decrease in the group’s LDL (“bad”) cholesterol.
However, the study also found that 10% of participants were using it when they shouldn’t -- for example, when they had liver disease or were pregnant.
This is not the first time the FDA has been petitioned by Merck to allow over-the-counter sale of statins. In 2005, the agency refused Merck’s request because the agency wasn’t convinced that people could tell if they were in need of the drug, says Dr. Eric Brass of UCLA, who worked on the FDA advisory committee at the time and now serves as a consultant to Merck. “The committee agreed that for the target population, lovastatin was safe and effective,” he adds.
Merck’s Rogers says that since 2005, Merck has improved its labels and performed a study to determine whether people would take it correctly, and most did, probably because of a flow chart on the label that takes the consumer step-by-step through the risk factors.
But the AMA opposes over-the-counter statin sales even if people take the pills correctly. In a letter to the FDA, Dr. Michael Maves, executive vice president and chief executive of the AMA, wrote that monitoring and treating high cholesterol and related conditions, such as diabetes, should be done by a physician. “The use of a statin to lower LDL cholesterol may be only one part of a more complex patient management strategy,” he wrote.
