THE CHOLES­TEROL DRUG CON­TRO­VERSY

THE DE­BATE ABOUT STATINS SHOWS THAT SCIENCE CAN’T AL­WAYS SUP­PLY EASY AN­SWERS

BBC Earth (Asia) - - The Last Word -

“TELLING PEO­PLE THEY’RE JUST FEEL­ING ‘AL­TER­NA­TIVE PAIN’ ISN’T LIKELY TO PROVE ALL THAT HELP­FUL”

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. 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 life-threat­en­ing 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.

Robert Matthews is a vis­it­ing pro­fes­sor in science at As­ton Univer­sity, Birm­ing­ham

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