The UK government has given the go ahead to the world's first over-the-counter statin drug, Johnson & Johnson MSD 's Zocor Heart Pro (simvastatin) but some doubt whether the move will provide real benefits to patients.

Experts on the Committee on Safety of Medicines (CSM) advised the government that the drug should be available without prescription in a 10mg dose in pharmacies across the UK from July.

Professor Gordon Duff, chairman of the CSM, said the case "has been made convincingly that the balance of potential health benefits and any possible risks is overwhelmingly positive".

Zocor Heart Pro is a member of a group of drugs called statins which are used to lower bad cholesterol and were previously prescribed prescription only to patients at high risk of heart disease.

The government says the move is part of long-term efforts to reduce deaths from heart disease and provide greater access to the potentially life-saving medicines. Statins are currently prescribed to around 1.8 million people in the UK and are thought to save 6-7,000 lives a year.

Some doctors are now suggesting a low-dose combination of statins and aspirin could be taken daily by everyone over 55, potentially cutting heart disease by 80%. Health secretary John Reid said: "We have already seen a 23% fall in premature deaths from heart death rates from heart disease and stroke over the past five years, on line to meet our target of a 40% reduction by 2010. The new move will allow more people to protect themselves from the risk of coronary heart disease and heart attacks.

"By extending the access to this drug we are giving people more choice about how they protect their health. We are committed to extending choice whenever advised it is safe to do so."

Some groups say the decision is more about saving the government money by transferring the cost of the drugs to the public, as statins cost the NHS over £700 million a year and are the biggest single area of drug expenditure.

The Royal College of General Practitioners has been one of the staunchest opponents of the OTC switch, and has serious doubts about the efficacy of the 10mg dose and the capacity of pharmacists to identify suitable candidates for the drug and provide the necessary after-sale monitoring, to ensure patient safety.

Dr James Kennedy, of the Royal College of GPs, said: "It's a decision that may be being made for expediency, rather than clinical reasons." He warned: "You could have someone whose cholesterol is absolutely normal who would not only be spending on something which had very little use, but they could also be putting themselves at risk.

The British Medical Association welcomed the decision but also expressed some reservations. BMA medical director Professor Charles George, said: "The evidence is that in people at risk of heart attack and stroke, taking 10mg of simvastatin each night can reduce their risk by about 27%. However, in order to ensure that these drugs reach the right people, patients should be encouraged to accept the offer of reliable cholesterol checks as well as taking appropriate lifestyle measures.

To meet these concerns, pharmacists will question customers thoroughly before supplying the drugs and monitor the individual's progress. Where the patient is found to be at high risk of developing CHD pharmacists will refer the person to a GP where statins, including higher doses, will still be provided on prescription.

Johnson & Johnson MSD say Zocor Heart Pro will be available in pharmacies from July for all men aged 55 and over, and women and men aged over 45 with known risk factors of heart disease.

The market for the OTC drug is estimated to be around 10 million people, with the cost in the region of £10 to £15 a month compared to £6.30 for an NHS prescription.

pharmafocus@pharmafile.co.uk