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Starting this month, British consumers will be able to buy a powerful, cholesterol-lowering drug without a doctors prescription. The U.K. government has billed the move, the first time a member of the class of drugs known as statins has been available over-the-counter, as a boon to public health, sure to help prevent Britain’s number one killer: heart disease. But within days of the May 13 announcement, doctors began vocal criticism of the decision, raising doubts about both the safety of and motivations behind it. And a similar step by the U.S. Food and Drug Administration seems inevitable, as drug companies are for the third time requesting permission to sell two different statins without prescriptions.

In a press release announcing the approval of the nonprescription sale of simvastatin, sold by Merck as Zocor, British Health Secretary John Reid noted that the Committee on Safety of Medicines had concluded the benefits of the shift outweighed the risk. This new move will allow more people to protect themselves from the risk of coronary heart disease and heart attacks, he said.

But a May 22 editorial in the British medical journal The Lancet said the decision to allow over-the-counter sales of the drug was made with little evidence on either the safety or efficacy of offering it to the public without physician monitoring. The U.K. Department of Health, the journal said, was turning the population into guinea pigs in this large-scale OTC experiment. The British Medical Association has publicly questioned not only the wisdom of the move but also the motives behind it, saying that the government is attempting to shift the cost of heart disease prevention from the National Health Service onto individual patients.

The decision and its outcome are being closely watched in the United States. Last November, reports surfaced that Merck was planning to ask the FDA to review Mevacor, the first statin sold and now off-patent, for OTC status. In 1997 and again in 2000 the FDA had rejected over-the-counter marketing applications from Merck for Mevacor and Bristol-Myers Squibb for Pravachol, another related statin, citing safety concerns. But the agency has softened its position: in 1997, regulators called all statins unsuitable for over-the-counter sale. Although the agency again rejected OTC sales of the statins in 2000, it withdrew that statement, leaving what some see as an opening for future approval.

I do think eventually well have over-the-counter statins, says Joshua P. Cohen of the Tufts Center for the Study of Drug Development; Cohen is an expert in switches of drugs from prescription to over-the-counter status. But, he cautions, there are concerns over efficacy, safety, and cost.

While statins do effectively lower cholesterol, they can’t simply be taken like antacids or allergy medications. For one thing, the same dose wont work for everyone. And unlike allergy or pain medication, where symptom relief is clear, cholesterol levels are not an easily diagnosed condition, says Cohen, leaving open the question of how patients taking the drug without a doctors supervision will know whats best for them.

A study published in the April 8 New England Journal of Medicine, for example, found that patients who received high doses of statins had 16 percent fewer cardiovascular events than a control group. But the British government approved only the lowest dose of simvastatin10 milligramsfor over-the-counter sale. In fact, prescription data from health data company IMS Health suggests that fewer than 30 percent of simvastatin prescriptions in Britain are for the 10-milligram dose; most simvastatin patients take 20 milligrams, and more than 25 percent take 40 milligrams. Doctors worry that without regular monitoring, patients may not find the right dose to affect their cholesterol levels.

Side effects are also a concern. Doctors routinely monitor patients taking statins for liver damage. And 31 patients taking the statin Baycol died from rhabdomyolysis, a rare but dangerous muscle breakdown that can lead to kidney and other organ damage; these deaths led to Baycols recall in 2001. You certainly dont want people taking an over-the-counter medication and dying from it, says Cohen. I wouldnt be too alarmist about it, but thats a real concern.

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Tagged: Biomedicine

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