Professor Sir Rory Collins, the austere director of the institute in Oxford that produce much of the evidence supporting the increasing use of cholesterol –lowering statins, is in hot water once more. Last week he declared that he intended to investigate himself.
What needed investigating was his own admission a few months ago that his unit – the CTT (Cholesterol Trialists Collaboration) – hadn’t actually done any research to establish the level of damaging side-effects of the drugs even though he had been claiming for over a decade that they were negligible. Senior medical figures, such as the editor of the BMJ, are outraged.
Regular readers may remember that at the time of that admission, HealthInsightUK posted a blog giving the background to the revelation, pointing out that for years various critics had been claiming that proper data on statin side-effects was missing.
This is an important issue. Something like 12 million people in the UK take these drugs, NICE recently approved a major expansion of the number eligible for a prescription and doctors are paid for prescribing them. But if risk from side-outweighs the benefits the whole project is pointless and dangerous.
Fox and hen house; bank CEO and tax evasion
In the circumstances, allowing Sir Rory to conduct the investigation is like Lord Green offering to uncover what was known about HSBC’s Swiss tax avoidance schemes or nodding through a plan by Fred Goodwin to review the Royal Bank of Scotland’s mergers and acquisitions policies. For a more detailed and less flamboyant account of the ongoing issue of CTT and its lack of transparency see this week’s BMJ.
But this is not just about foxes being allowed to check on the hen houses it’s yet another example, of how our system of evidence based medicine that is supposed to be giving doctors and patients reliable guidance is capable of generating total confusion.
Of course we need to know the risks but ideally without the sticky fingers of vested interests smearing the results. The truth is that as far as the commercial side of cholesterol lowering is concerned, statins are so yesterday. When they were expensive patent-protected drugs there was a strong incentive to keep estimates of their side effects frequency low. But now they are all off patent and so very cheap, powerful forces have a strong interest in pushing up estimates of their risk.
That’s because waiting in the wings is a new class of far more potent, patented and so far more expensive, cholesterol lowering drugs known technically as PCSK9 inhibitors. They work by making the liver pull more cholesterol out of the bloodstream. A simple way to explain why we need them is to point out that they avoid one of the serious problems affecting statins.
Who knew so many were statin intolerant?
This, believe it or not, is that statins caused side-effects in lots of people. It’s been named “statin intolerance” but it means the same thing. Experts have been estimating the percentage of patients suffering from “statin intolerance” at between 10% and 20%. This is a far cry from the level of 1% that Sir Rory had been claiming at various times.
In fact Patrick Moriarty of the University of Kansas Medical Centre put it even higher in a paper he presented at the American Heart Association (AHA) meeting in Chicago in Nov last year. “Statin intolerance is one of the most common causes of an inability to reach goals in patients who need lipid lowering therapy,” he said. ‘It affects up to 25% of all statin-treated patients.’
And the side effect rate might be even higher. An American organisation called “Statin Usage” (funded by pharmaceutical company and The National Lipid Association) recently ran a big survey to find out why patients stop taking statins – described as “one of the biggest barriers to treatment”. The answer was because of side-effects at a level far higher than claimed by those concerned about “statin intolerance”. Sixty two percent said they stopped because of side-effects and 52% who didn’t refill their prescription, did so because of side-effects.
These wildly varying estimates are a long way from the Promised Land of hard data where it is possible to make informed choices. What’s more the story gets even more tangled and absurd. The cholesterol hypothesis that all this statin prescribing is based on is looking as if it could be a house of straw.
Elephant in cholesterol-lowering room
The industry and the medical profession have for years resolutely turned a stone deaf ear to voices pointing out the elephant in the cholesterol-lowering room. There are plenty of sensible careful studies that fail to find a connection between raised cholesterol and risk of heart disease.
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