THE CHOLESTEROL DRUG CONTROVERSY
The debate about statins shows that science can’t always supply easy answers
In these days of fake news and ‘alternative facts’, science gives us the tools to blast through the bluster. But even the scientific method can struggle to cut through really tough stuff.
Take the ongoing controversy over statins, the cholesterol-lowering drugs that millions of people take every day to help them avoid heart attacks and strokes. For years, patients have complained of getting muscle pain so severe they’ve stopped taking their pills. Quite why statins should have this effect isn’t clear; what is clear, though, is that while patients believe these pains are real, many medical experts don’t.
Now a huge scientific study involving over 10,000 patients has shown that the experts were right: the muscle pains are all in the mind. The evidence comes from a ‘double blind’ randomised trial, widely recognised as the gold standard research study. The participants were randomly assigned either to receive the treatment or not – with neither they nor the researchers knowing who got what.
When the results were analysed, they showed that around 2 per cent of participants reported muscle pains over the following year – regardless of whether they were taking statins or not. But then the researchers looked at what happened once people knew they were taking statins. Complaints of muscle pain suddenly became over 40 per cent more common among those taking the drug.
Reporting their work in the peerreviewed medical journal The Lancet, the researchers explain that this is consistent with the so- called ‘nocebo effect’ – the evil twin of the betterknown placebo effect – in which simply knowing they are taking an active drug leads people to believe it’s having a bad effect on them.
The results made headlines, and prompted calls for patients not to gamble with their lives by wrongly blaming statins for symptoms and ditching them, thus increasing their risk of heart attacks and strokes. On the face of it, this is a textbook example of how science can debunk ‘alternative facts’. Yet it’s not quite as simple as that. For a start – and as the lead researcher said at the time – just because the pain is caused by the nocebo effect, doesn’t mean patients don’t feel it. Telling people they’re just feeling “alternative pain” isn’t likely to prove all that helpful. But there are other issues with the research, too. First, the study itself was finished over a decade ago and involved only one type of statin, at a dosage lower than is commonly prescribed today. The participants were all European males – clearly unrepresentative of the population as a whole – and they were not instructed to report any side- effects, raising the possibility that many went unreported. Then there’s the awkward fact that the study was funded by drugs companies who make statins. So while the basic study design was scientifically impeccable, the details of how it was carried out leave question marks hanging over its conclusions. That’s also true for the bigger question surrounding statins: who should take them? While the benefits for patients at high risk of cardiovascular disease are undisputed, medical experts are divided on the merits of giving statins to anyone else. Anyone who thinks ‘alternative facts’ are the sole preserve of politicians should check out the ongoing spat between The Lancet and the British Medical Journal on all this. If you’re taking statins, you should see your doctor before deciding what to do in the light of all the conflicting messages, but it’s worth bearing in mind that while the side effects may be unpleasant, they’re not as lifethreatening as a heart attack or stroke. For the rest of us, the statins controversy serves as a reminder that not even science can always guarantee nice, simple answers to complex questions.