LONDON — In a bid to prevent heart attacks and strokes, Britain will be the first country to permit nonprescription sales of a cholesterol-lowering drug, the government said Wednesday.
Some expert groups welcomed the decision, but others said people taking such drugs needed supervision and an assessment of risks.
Health officials said a low-dose version of simvastatin, marketed as Zocor by Merck & Co. of Whitehouse Station, N.J., will be available without a prescription at pharmacies across the country starting later this year. No date was announced.
Simvastatin belongs to a class of drugs called statins, considered a powerful weapon against the buildup of fat deposits that clogs arteries, leading to heart attacks and strokes.
Pharmacists will ask people a series of questions and, if needed, will offer a range of optional health tests to ensure it is safe to take the drug, said Health Secretary John Reid. Pharmacists will have the power to refuse to sell the drug.
The Royal College of General Practitioners and the British Medical Association raised concerns.
The drugs still are available only by prescription in the United States.
"We are concerned that there won't have been a sufficiently thorough risk assessment before the drug is purchased," said Dr. John Chisholm, chairman of the British Medical Association's general practitioner committee. Patients on statins should be regularly monitored to assess the effectiveness of the treatment, he added.
"For those patients who do need to take statins," he said, "the low dosage available over the counter may not be enough to reduce cholesterol to safe levels."
The drug may be sold to people who do not need it, said Dr. Jim Kennedy of the Royal College of General Practitioners.
"The risk of the drug may then outweigh the benefits," he said.
Side effects are usually mild and temporary, and mostly involving muscle aches and headache.
The British Heart Foundation, which funded one of the key studies establishing the benefits of statins, welcomed the move.
"The evidence is that, in people at risk of heart attack and stroke, taking 10 milligrams of simvastatin each night can reduce their risk by about 27 percent," said Sir Charles George, medical director of the foundation.
The European Society of Cardiology also endorsed the move.
"This is a fairly courageous stand," said Dr. John Martin, a spokesman for the group. "It's partly pragmatic because if everybody who needed a statin had it prescribed by a doctor the health service would be overwhelmed."
"There is a move in medicine away from doctors being in control toward patients being in control. This is part of that movement and this will occur more and more. I think it's good that patients have to be more informed about their health and take more responsibility for it," said Martin, a professor of cardiovascular medicine at University College in London.
He said the side effects from statins are so low that giving the drug to a few people who don't need it is not inappropriate because most of the population will benefit.
"At that dose, these are infinitessimal risks," he said. There is no normal dose for statins. Experts say that the lower the cholesterol, the better, even among people who's readings are in the normal range.
However, Martin noted that taking the tablet will have no effect on smokers. Smoking is the greatest risk factor for heart disease.
"If you smoke, reducing cholesterol is not the answer. The answer is to stop smoking," he said. "If you don't smoke, then reducing your cholesterol is the answer."
Under current guidelines, doctors can prescribe statins for those patients who have a 30 percent chance of having a heart attack in the next 10 years.
Johnson & Johnson, which has a U.S. joint venture with Merck, will market the over-the-counter version of simvastatin in Britain.