Sunday, May 23, 2004
While pharmacists' groups and the British Heart Foundation backed the reclassification, others have not been so supportive. Dr John Chisholm, chairman of the BMA's General Practitioner Committee, was concerned that patients would not have a thorough risk assessment, that the dose may be too low, and that there was potential for side effects.
'If a drug treatment is worth taking it should be provided equitably and available to all patients at NHS expense and on the basis of need, not their ability to pay,' he said. The King's Fund, a charitable health research foundation, said it was another example of 'creeping charges' in the NHS.
The Consumers' Association said no specific clinical trials had proved that selling the product over the counter was effective in the target population. It also said that the real reason behind the switch was that simvastatin lost its patent protection in May 2003.
As DB over at Med Rants put it, it really is about the money. The British government has to spend billions on statin therapy through the NHS. By making them over-the-counter, they put the cost burden on the patient. And both the pharmacists and the drug company stand to make more money by putting them on the unrestricted open market.
But is this a medically wise move? The evidence would suggest not. Here's a look at the studies on statins in primary prevention for heart attacks and strokes:
In the pooled data the statins reduced the cardiovascular measures, total myocardial infarction and total stroke, by 1.4% as compared to control. This value indicates that 71 mostly primary prevention patients would have to be treated for 3 to 5 years to prevent one such event.
Even more worrisome, none of the studies took a good look at adverse events from using statins. And although there's a slight decrease in heart attacks and strokes, the overall mortality is the same whether or not patients took statins. You might be decreasing your risk of a quick death by heart attack, only to have it be substituted by a slow death from cancer. Or emphysema. Or some other chronic illness.
Compare that to aspirin, which we currently recommend for the prevention of strokes and heart attacks:
For patients similar to those enrolled in the trials, aspirin reduces the risk for the combined endpoint of nonfatal myocardial infarction and fatal coronary heart disease (CHD) by 28 percent .....For 1,000 patients with a 5 percent risk of CHD events over 5 years, aspirin would prevent 14 myocardial infarctions.
That translates into 71 people taking aspirin to prevent one heart attack, a slight advantage over statins. But where the difference really comes in is in the price tag. A one month supply of ten milligrams of Zocor costs $69.99 at Drugstore.com, but five months of aspirin is only $7.29.
Now, the statin proponents will argue that aspirin is more dangerous than statins. It can cause bleeding in the brain (hemorrhagic stroke) and in the gut (bleeding ulcers.) And in fact, the data on aspirin show that out of 1000 people taking it for five years, one would have a hemorrhagic stroke and three would have a gastrointestinal bleed. We know the risks of aspirin. It's a drug that's been widely used for over a hundred years. We don't know all the risks of statins. They've only been widely used for around fifteen years. And the fact that the studies used to support their widespread, barely discriminate use ignore adverse effects is not reassuring. It's even more disturbing to hear their proponents claiming they have no adverse effects, because they do. It's just plain hubris to suggest otherwise.
ADDENDUM: If all that talk about aspirin side effects gives you the willies, you can go here to calculate your risk of heart disease over the next ten years. If it's less than five percent, you probably don't need to take aspirin.
posted by Sydney on 5/23/2004 03:19:00 PM 1 comments
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