Cholesterol drug move worries doctors
Sarah Boseley, health editor
Thursday May 13, 2004
Source: The Guardian
The government was yesterday accused of allowing the public to be used as guinea pigs after it announced that powerful cholesterol-lowering drugs called statins can be be sold in high street pharmacies.
Statins have been hailed as modern miracle drugs - Rory Collins of the British Heart Foundation's heart protection study called them the new aspirin, only safer.
But while they have a good record of preventing heart attacks in high-risk patients, some statins have been found to have rare but serious side-effects, and most agree the best way to lower cholesterol is through diet and exercise.
Around 1.8 million people are already on statins on the advice of doctors monitoring their condition. The Department of Health says it is estimated that the drugs save 6,000-7,000 lives a year. Some critics yesterday suggested that the government was trying to save money from the soaring NHS drugs bill by allowing people to buy their own.
The move "is tantamount to using the UK public as guinea pigs and smacks of a cost-cutting exercise," said the Consumers' Association. The good track record of the drugs in the past had been under controlled conditions, with patients under the care of their doctor. Pharmacists were supposed to carry out simple tests to ensure the patient was suitable for the drugs, but they may not know all the medical history, it said.
Just one statin will be available directly from the pharmacist immediately. Merck, the manufacturer of one of the leading heart drugs, simvastatin (brand name Zocor) started the ball rolling by requesting the change of status. Simvastatin has just gone off patent, so NHS doctors will now increasingly be prescribing cheaper generic copies.
Experts on the committee on the safety of medicines advised the health secretary, John Reid, to allow the change and after a public consultation he has done so.
"We have already seen a 23% fall in premature death rates from heart disease and stroke over the past five years, on line to meet our target of a 40% reduction by 2010," said Mr Reid.
But yesterday the Royal College of GPs and the King's Fund were among the groups that showed serious concern. The GPs said they were unhappy that tests by the pharmacist to establish that the patient did indeed have a high cholesterol level were not obligatory. They also worried that the pharmacist would not know the patient's medical history and that there was no system for the pharmacist to let the doctor know the patient was taking statins.
"Pharmacists will be under pressure to assess the risk of cardiovascular disease," said Jim Kennedy of the college. "With lower socio-economic groups at greater risk of cardiovascular disease and least able to afford this preventative measure we have to urgently consider how access to these useful drugs can be equitable."
Niall Dickson, chief executive of the King's Fund, said he was concerned the decision was rooted in cutting the drugs bill. "Over-the-counter statins have the potential to save many lives and should be provided equitably and available to all patients who could benefit at NHS expense - not just to those who are most at risk," he said.
The Stroke Association said it was in favour of any treatment that was proven to work. "It is essential that the medication be only given to patients who would benefit from it."
Some doctors worried that serious family histories of heart disease will go undetected in those who buy statins over the counter instead of going to a GP. Professor Steve Humphries, from London IDEAS Genetics Knowledge Park, who is attempting to track down 100,000 people with genetically inherited family cholesterol problems which put them and half their relatives at serious risk of heart attack, said such people would need a much higher dose of statins than is available over the counter.
"Taking this pill, instead of being seen by a doctor, will put them at high risk," he said.
Pharmacists, on the other hand, were delighted at the move. "This switch will enhance patient care and give pharmacists more opportunity to use their skills," said Gillian Hawksworth, president of the Royal Pharmaceutical Society.
Simvastatin has been available in the UK for 14 years without problems, but a more powerful and newer statin, cerivastatin (brand name Baycol), made by Bayer, was withdrawn in 2001 after it was associated with 100 deaths from side effects including severe muscle wasting and kidney damage.
The fats: how diet affects the heart
Cholesterol is a fatty substance, made mainly by the liver, which is an essential component of every cell wall in the body. A surplus of the wrong sort is harmful.
It contributes to the build-up of fatty deposits on the walls of arteries. These deposits can tear off and form a clot which can block the artery and lead to a heart attack.
High-fat diets and lack of exercise lead to raised cholesterol levels, although there can also be a genetic element. Cutting down on animal fats and taking aerobic exercise can bring down levels of the bad cholesterol, known as low-density lipo-protein or LDL-C, and raise levels of good cholesterol (high density lipoprotein or HDL-C).
Sometimes diet and exercise are not enough and drugs may be prescribed. Statins block the production of cholesterol in the liver and help it clear the bad cholesterol from the blood.
In those who have high cholesterol levels and are at risk of a heart attack, the benefits of statins outweigh the possible side-effects. There is a small risk (1-2%) of developing abnormalities in liver tests.