Consumer groups and doctors have hit out at the move to allow a heart 鈥渨onder drug鈥� to be sold over-the-counter in the UK.
No other country in the world allows statins, hailed as miracle drugs for the heart, to be sold without a doctor鈥檚 consultation. But now simvastatin -named Zocor Heart Pro commercially 鈥� is to be sold to those at risk of coronary heart disease after a just short consultation with the pharmacist. The drug has been shown to slash premature deaths from heart disease,
The step, announced by the UK government on Wednesday, 鈥渋s tantamount to using the UK public as guinea pigs and smacks of a cost-cutting exercise鈥�, warns the UK鈥檚 Consumer Association.
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鈥淐rucially there have been no specific clinical trials to prove that over-the-counter use of Zocor is effective in the target population of people at moderate risk of heart disease,鈥� it says. The group adds that the decision has been made 鈥渋n the full knowledge of uncommon but potentially devastating side-effects鈥�.
The government decision means that people will be able to buy the drug, which has just come off patent, by summer 2004.
鈥淲e have already seen a 23 per cent fall in premature death rates from heart disease and stroke over the past five years, on line to meet our target of a 40 per cent reduction by 2010,鈥� said health secretary John Reid. 鈥淭his new move will allow more people to protect themselves.鈥�
Medical record
The government based its decisions on recommendations by the Committee on Safety of Medicines, an independent advisory body.
The CSM鈥檚 report highlights that simvastatin can cut levels of 鈥渂ad鈥� cholesterol 鈥� LDL-cholesterol 鈥� by 27 per cent. This huge drop in turn cuts the risk of a heart attack or death due to coronary heart disease by one-third after three years of treatment.
But the Royal College of General Practitioners (RCGP) is concerned. 鈥淲e understand that while a range of health tests will be offered before simvastatin is dispensed by a pharmacist the tests are not obligatory and we are concerned by this news,鈥� says Jim Kennedy, prescribing spokesperson for the RCGP.
鈥淧harmacists currently do not have access to a patient鈥檚 medical record which would help them judge whether simvastatin is necessary and help patients get appropriate and optimum treatment while protecting them against interactions and adverse effects,鈥� Kennedy says.
Grapefruit juice
But patient safety is a 鈥減rime consideration鈥�, says Gordon Duff, chairman of the CSM. 鈥淭he safety of carrying out this switch has been debated thoroughly and the case made convincingly that the balance of potential health benefits and any possible risks is overwhelmingly positive鈥�.
The CSM鈥檚 document highlights rare but serious side-effects to simvastatin including muscle problems and liver injury. It cautions that drinking large quantities of grapefruit juice can interact with the drug. And drinking more than the recommended weekly amounts of alcohol 鈥� 28 units for men, and 21 for women 鈥� with simvastatin could also affect the liver.
The RCGP also warns that people of lower socio-economic backgrounds may not be able to afford the drugs 鈥� making access to life-saving medication less equitable.
Statins are currently prescribed to 1.8 million people and are estimated to save 6000 to 7000 lives a year in the UK.