UK doctors concerned about motives for making statins non-prescription drugs

Main Category: Statins
Article Date: 13 May 2004 - 0:00 PST

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After the UK government announced it was to make statins OTC (over the counter) drugs, some doctors and consumer groups wonder whether the UK population is being used as guinea pigs.

Some statins have been found to have side-effects. These are rare, but can be serious. The problem is there are no huge studies to measure how widespread the side-effects are. Some doctors are concerned about this. Others say that the best way to protect yourself from the effects of high cholesterol is through diet and exercise.

Rory Collins, British Heart Foundation, on the other hand, has called statins the new miracle drug. He says they are the new aspiring - but one hell of a lot safer.

There are 1.8 million people in the UK who are already on statins as a prescription drug. According to UK health authorities, statins are currently saving six to seven thousand lives every year.

Other people think the UK government's move was because of costs. In the UK the elderly, children, pregnant women and the unemployed get their prescriptions free - they pay nothing for their prescription drugs. The ones who have to pay only pay £6.40 (ten dollars) per prescription. A doctor can write out a prescription for three months supply of a drug and all you have to pay is ten dollars or nothing - the state pays the difference. If statins are OTC, people may just go and buy it rather than bother going to their doctor and getting a prescription. By doing it this way they will be paying the full price. Many people might do that (if they have the money) if they do not want the hassle of taking the morning off, sitting in the doctor's waiting room and then seeing him/her. The government would save a lot of money on these people.

The Consumer's Association in the UK said of the government's move '…is tantamount to using the UK public as guinea pigs and smacks of a cost-cutting exercise. Good track record of the drugs in the past has been under controlled conditions, with patients under the care of their doctor. Now pharmacists are supposed to carry out simple tests to ensure the patient is suitable for the drugs, but they will not know all the patient's medical history."

John Reid, UK Health Secretary, said "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."

UK GPs are very concerned. They did not like the fact that the cholesterol test the pharmacist is supposed to carry out is not compulsory. In other words, the patient does not have to have the cholesterol test in order to get the drug. They also said that the pharmacist would not know what other drugs the patient was on, and the doctor would not know which of his patients were on statins. Nothing was set up to get the pharmacist to inform the patient's doctor that he/she was on statins.

Jim Kennedy, of the Royal College of General Practitioners, said "Pharmacists will be under pressure to assess the risk of cardiovascular disease. 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."

The UK Stroke Association said that it is essential that the medication be only given to patients who would benefit from it.

Other doctors say that there are many people who need very high doses of statins, higher than other people. These are people with genetically inherited family cholesterol problems and their relatives. If they treat themselves at the pharmacy and the pharmacist does not know about their family backgrounds they could be at risk if their dosage is not high enough.

The association that represents pharmacists, The Royal Pharmaceutical Society, was over the moon with the news. President of the Royal Pharmaceutical Society said "This switch will enhance patient care and give pharmacists more opportunity to use their skills."

Cerivastatin (brand name Baycol), a powerful statin was taken off the market in 2001 because of serious side-effects - muscle wasting and kidney damage. In fact, it was associated with 100 deaths. Other statins, on the other hand, have been around for a long time and are regarded as relatively safe.

WHAT ARE STATINS AND HOW DO THEY WORK?
(From: http://www.patient.co.uk/showdoc.asp?doc=27000367)

Statins are a group of medicines which are commonly used to reduce the level of cholesterol in the blood. They include atorvastatin, fluvastatin, pravastatin, rosuvastatin, and simvastatin. They each have different brand names. Statins work by blocking the action of a certain enzyme (chemical) in the liver which is needed to make cholesterol.

WHO SHOULD TAKE A STATIN?

Your doctor will advise if you should take a statin. One is usually advised if:

-- you have an atheroma-related disease (heart disease, etc). A statin helps to reduce the risk of these conditions getting worse. Or, it can delay the progression of the disease.

-- you are at increased risk of developing an atheroma related disease. For example, if you have diabetes, or other 'risk factors'. See leaflet called 'Cholesterol' for details.

Note: a statin is just one factor in reducing your risk of developing atheroma-related diseases. Just as important are: eating a healthy diet, not smoking, taking regular exercise, losing weight if you are overweight, reducing blood pressure if it is high, and taking a daily low dose of aspirin if advised to do so. See a separate leaflet called 'Preventing Heart Attacks and Stroke' for details.

WHAT HAPPENS WHEN I TAKE A STATIN?

You should have a blood test before starting treatment. This checks the level of cholesterol. It also checks if your liver is working properly. After starting treatment, you should have a blood test within 1-3 months to check that the liver has not been affected by the medication. Also, to check the cholesterol level to see how well the statin it is working.

The target for most people on statin treatment is to reduce the cholesterol level to:

-- less than 5 mmol/l, or

-- to reduce the level by 25-30% if that produces a lower level than 5 mmol /l.

If the target is not reached, the dose may need to be increased. Once the target level is reached, you should continue to take the statin indefinitely. You should have a blood test every now and then as advised by your doctor or nurse to check that your liver remains healthy.

WHAT ARE THE POSSIBLE SIDE-EFFECTS OR PROBLEMS WITH STATINS?

Most people who take a statin have no side-effects, or only minor ones. Read the information leaflet which comes with your particular brand for a full list of possible side-effects. These include: headache, pins and needles, abdominal pain, bloating, diarrhoea, feeling sick, and a rash.

You should tell your doctor if you have any unexpected muscle pains, tenderness or weakness. This is because a rare side-effect of statins is a severe form of muscle inflammation.

You should not take a statin if you have active liver disease, if you are are pregnant or intend to become pregnant, or if you are breast feeding. You should stop a statin if you develop liver disease.

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