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FDA Panel to Consider Over-the-Counter Statin
Date:12/13/2007

Experts oppose idea on medical and safety grounds

THURSDAY, Dec. 13 (HealthDay News) -- For the third time in seven years, a U.S. Food and Drug Administration advisory panel has been asked to recommend making Merck & Co.'s statin drug Mevacor available over the counter.

But with groups such as the American Medical Association, Public Citizen and Consumers Union lined up against it, experts think Merck's proposal is likely to be rejected once again when the panel meets on Thursday.

"The third time is not the charm," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. "It's time to move on."

Merck's proposal is being presented to a joint meeting of the FDA's Nonprescription Drugs Advisory Committee and its Endocrinology and Metabolic Drugs Advisory Committee. The FDA does not have to follow the advice of its advisory panels, but it usually does.

In its proposal, the Whitehouse Station, N.J.-based pharmaceutical giant noted that many people with high cholesterol go untreated, increasing the risk for heart attack and other heart problems.

"The availability of a statin without a prescription is anticipated to help narrow the cholesterol treatment gap," Merck stated. "Consumers already attempt to manage their cholesterol by purchasing unproven food and dietary remedies, and the availability of an OTC statin would give them the option of purchasing an effective pharmacologic therapy. Mevacor Daily [lovastatin 20 mg] is an appropriate choice for an OTC statin. The efficacy and safety of lovastatin has been well-established through the 20 years of marketed use of the product as well as by the post-approval megatrials."

However, in 2000 and in 2005, the FDA rejected similar proposals because of concerns about how the drug would be used by consumers, potential side effects, and the need to monitor the people taking statins.

Merck is hoping that some new study data will sway the committee this time.

Some experts do agree with the OTC idea.

"There is a public health benefit in making statins available over the counter," said Dr. Antonio M. Gotto Jr., a dean and professor of medicine at Weill Cornell Medical College in New York City and former president of American Heart Association.

Statins are safe and effective, said Gotto, who is also a consultant for Merck. "In addition, the American population has reached the point where they are able to assume a greater degree of responsibility for their own health care," he said.

However, a preliminary FDA report released Tuesday concluded that the proposal should be rejected.

According to that report, Mevacor could be "a reasonably safe and effective" option -- if consumers used it properly. But studies done by Merck failed to show that most people could judge if they needed the drug or not. In addition, some 30 percent of those who said they would buy the drug over the counter have heart disease or diabetes or had had a stroke -- conditions that need a doctor's care.

The studies "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," the preliminary assessment concluded.

Nissen is opposed to the over-the-counter sale of statins on several counts.

"I am very strongly opposed to statins over the counter for a lot of reasons," Nissen said. People with high cholesterol don't know they have it, because there are no symptoms, he said. "The only way you know is if you are tested."

In addition, test results have to be interpreted to determine risk factors and whether a statin is needed or not, Nissen said. "I don't see how individuals can do that for themselves," he added.

Nissen also noted that statins need to be taken regularly to be effective, but data indicate that over-the-counter medications are not usually taken consistently. Moreover, statins can have rare but serious side effects, such as liver abnormalities, and are contraindicated for pregnant women.

"What I worry about is that a lot of the people who take statins over the counter will be the so-called 'worried well,' who don't really don't need a cholesterol-lowering medication," Nissen said.

"This is not a disease that you can treat with a one-size-fits-all approach. That's what's being attempted here with a 20 milligram, low-dose statin," he said. "I see no public health advantage in doing this, and I see lots of potential problems."

In a letter to the committee, Dr. Michael D. Maves, executive vice president and CEO of the American Medical Association (AMA) expressed the association's opposition to the Merck proposal for many of the same reasons as Nissen.

"The AMA strongly opposes the Rx-to-OTC switch of Mevacor (lovastatin) as a cholesterol-lowering agent. While the AMA recognizes there is an underutilization of statins to treat hypercholesterolemia in this country, we do not believe that moving a statin to OTC status is the solution. To potentially lose the benefits of physician supervision by switching statins to OTC status would, in the AMA's view, be detrimental to the health of many individuals and to the public," Maves wrote.

Consumers Union has also lined up against the Merck proposal.

"Consumers Union is urging the FDA to reject Merck's latest application to sell an over-the-counter version of the cholesterol-lowering medicine Mevacor, primarily because high cholesterol can't be self-diagnosed, many people with elevated cholesterol can bring it under control with diet and lifestyle changes, and statins are potent drugs that carry the risk of serious side effects," the group said in a prepared statement.

Another opponent of the proposal hopes the committee will reject the idea.

"I have testified against this twice, and I know we will oppose it now," said Dr. Sidney M. Wolfe, director of the Health Research Group of Public Citizen.

To answer these objections, Merck said that its package promotes using Mevacor as part of an overall program and under a physician's advice.

"The people who would be the candidates for over-the-counter Mevacor are people who have had blood tests and know they have elevated cholesterol that should be treated," said Merck spokesman Ron Rodgers.

Rodgers noted the packaging says that patients should have a cholesterol test before using the drug. "The materials supporting over-the-counter Mevacor encourage consumers to get tested on a periodic basis for side effects and cholesterol monitoring," he said.

Merck thinks that even though patients should be under a doctor's care, buying Mevacor over the counter will make it more likely that they will get and use the drug, Rodgers said.

While nothing prevents consumers from taking Mevacor without tests and monitoring, "Merck's package encourages people to get tests and follow a healthy lifestyle," Rodgers said.

Gotto agreed that as long as people follow the program that Merck has developed, use of OTC statins could bring real gains for patients. "I am a believer in the health benefits of statins, and used according to this program they will prevent a lot of cardiac events," he said.



SOURCES: Steven E. Nissen, M.D., chairman, department of cardiovascular medicine, Cleveland Clinic; Sidney M. Wolfe, M.D., director, Health Research Group of Public Citizen, Washington, D.C.; Ron Rodgers, spokesman, Merck & Co., Whitehouse Station, N.J.; Antonio M. Gotto Jr., M.D., dean and professor, medicine, Weill Cornell Medical College, New York City, and former president, American Heart Association; statement, American Medical Association; statement, Consumers Union


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