The Sunday Telegraph

Could statins be the health catas­tro­phe of a gen­er­a­tion?

As two ma­jor new stud­ies ap­pear to dif­fer over whether the drugs do more harm than good, Justin Smith weighs up the ev­i­dence


When they be­gan to be pre­scribed in earnest in the mid-Nineties, statins were re­garded by many as mir­a­cle drugs. The choles­terol-low­er­ing pills, in­tended to com­bat heart dis­ease, marked a turn­ing point in medicine from cure to pre­ven­tion; it was pre­sumed they would be an over­whelm­ing force for good, sav­ing mil­lions of lives.

On Fri­day, a ma­jor study of 30,000 pa­tients by Im­pe­rial Col­lege Lon­don (pub­lished in JAMA Net­work Open, an Amer­i­can Med­i­cal As­so­ci­a­tion jour­nal) os­ten­si­bly con­firmed this nar­ra­tive, show­ing that dou­bling the dosage of statins for those who have al­ready had a car­dio­vas­cu­lar event could pre­vent an ex­tra 12,000 heart at­tacks and strokes a year.

Yet what is also be­gin­ning to be­come ever more ap­par­ent is what some in the med­i­cal com­mu­nity – and my­self, as a re­searcher and film­maker on the sub­ject – have been ar­gu­ing for years. That overuse of statins in those with­out a car­dio­vas­cu­lar con­di­tion could in fact be­come the big­gest health catas­tro­phe of a gen­er­a­tion.

An­other au­thor­i­ta­tive study pub­lished last week is the lat­est in a grow­ing body of ev­i­dence to sug­gest not just that statins may have been sig­nif­i­cantly over­pre­scribed, but also that, for many, the risks of tak­ing them as a pre­ven­tive mea­sure could out­weigh their ben­e­fits.

The anal­y­sis, pub­lished in An­nals of In­ter­nal Medicine, an Amer­i­can jour­nal, ex­am­ined the four most com­monly pre­scribed statins us­ing data from 40 pre­vi­ously pub­lished ran­domised clin­i­cal tri­als.

Re­searchers found that statins were likely to pro­vide ben­e­fits at a sub­stan­tially higher health risk than ex­pected, sug­gest­ing that the 10-year risk thresh­olds used in the cur­rent guide­lines are set at a level that could be do­ing more harm than good.

Prom­i­nent voices who have ques­tioned the cur­rent wide­spread use of statins in­clude Sir Richard Thomp­son, the Queen’s for­mer per­sonal physi­cian and past pres­i­dent of the Royal Col­lege of Physi­cians. In ad­di­tion, the Bri­tish Med­i­cal Jour­nal has in re­cent years taken a po­si­tion against the wide­spread use of statins.

But in spite of this mount­ing con­tro­versy, statins re­main among the most com­monly pre­scribed drugs in the world – and the UK is no ex­cep­tion.

In 2013 it was es­ti­mated seven mil­lion peo­ple were be­ing pre­scribed the drugs in Bri­tain (al­though the NHS claimed in 2017 that fig­ure was ac­tu­ally four mil­lion). In any case, ac­cord­ing to the Na­tional In­sti­tute for Health and Care Ex­cel­lence guide­lines, 12mil­lion Brits would be el­i­gi­ble for statins.

The rise in so-called “health MoTs” for adults over 40 in Bri­tain has fur­ther in­creased the num­bers be­ing of­fered statins as pri­mary means of pre­ven­tion against heart dis­ease. For many, it has be­come a choice we feel pres­sured into.

Heart dis­ease is the lead­ing cause of death world­wide, so it’s un­der­stand­able that health au­thor­i­ties have al­lo­cated huge re­sources over the last few decades to fight it. Much of this ef­fort has been based on the idea that one of the main causes of heart dis­ease is choles­terol. As a re­sult, choles­terol­low­er­ing med­i­ca­tions – statins in par­tic­u­lar – have be­come, by far, the most widely used in­ter­ven­tion.

The first set of choles­terol treat­ment guide­lines were de­vel­oped in the United States in 1988 and have been up­dated ev­ery few years since, lead­ing to no­table in­creases in the num­ber of peo­ple deemed el­i­gi­ble.

In 2013 the Amer­i­can Col­lege of Car­di­ol­ogy and the Amer­i­can Heart As­so­ci­a­tion pub­lished rec­om­men­da­tions that, if fol­lowed, would lead to a dou­bling of the num­ber of peo­ple who take statins in the UK and US. In fact, ac­cord­ing to Prof John Ioan­ni­dis at Stan­ford Univer­sity School of Medicine, those rec­om­men­da­tions meant that well over one bil­lion of the world’s pop­u­la­tion be­came el­i­gi­ble.

This ad­vice was con­tro­ver­sial not just be­cause of the large in­crease in the num­ber of po­ten­tial pa­tients, but also be­cause the cal­cu­la­tor used to as­sess an in­di­vid­ual per­son’s risk for car­dio­vas­cu­lar dis­ease was found to over­es­ti­mate the risk – plac­ing some peo­ple into the statin el­i­gi­bil­ity group that were un­likely to need them.

At the time, the Bri­tish Med­i­cal Jour­nal also pub­lished an ar­ti­cle ques­tion­ing po­ten­tial con­flicts of in­ter­est – half of the pan­elists re­spon­si­ble for the rec­om­men­da­tions had dis­closed cur­rent or re­cent ties to drugs com­pa­nies, rais­ing con­cerns over per­ceived, though un­proven bias.

True enough, statins are big busi­ness. In 2017 the Lon­don-based re­search firm Vi­sion­gain said the global choles­terol-low­er­ing in­dus­try is worth $19.2bil­lion (£15bil­lion) and is fore­cast to grow 4.9per cent each year dur­ing the next five years.

One statin, Lip­i­tor, gen­er­ated more than $13bil­lion in 2006 for the phar­ma­ceu­ti­cal gi­ant Pfizer be­fore it went off patent in 2011.

The anal­y­sis pub­lished this week makes an at­tempt to fac­tor into the equa­tion that statins may do us harm.

Stud­ies have shown that they can cause a range of health prob­lems in­clud­ing mus­cle dam­age and weak­ness, mem­ory is­sues, type-2 di­a­betes and erec­tile dys­func­tion. A study pub­lished in the jour­nal Na­ture ear­lier this year also found that they in­hibit the growth of some po­ten­tially use­ful bac­te­ria in the gut, al­low­ing other bac­te­ria to flour­ish and be­come su­per­bugs re­sis­tant to an­tibi­otics.

There is, how­ever, a long way to go be­fore the full ex­tent of statin side ef­fects can be quan­ti­fied prop­erly.

Statin sup­port­ers of­ten say the rate of side ef­fects is very low, and that mus­cle pain, the most com­monly re­ported side ef­fect, is imag­i­nary. They re­fer to the no­cebo ef­fect (the op­po­site of a placebo): the idea that health prob­lems from other causes are blamed on a pre­scribed med­i­ca­tion be­cause of a pre­con­ceived idea that the med­i­ca­tion will cause them harm.

Dur­ing the nine years I have been closely fol­low­ing this de­bate, I have re­ceived hun­dreds of mes­sages and emails from peo­ple who have been harmed by the drugs; many of whom are un­for­tu­nately still re­cov­er­ing years af­ter stop­ping tak­ing them.

What I have seen dur­ing the last few years in par­tic­u­lar is that pa­tients have lost re­spect for their doctor. They have of­ten been ig­nored when they tried to voice their con­cerns, and I have re­ceived a num­ber of ac­counts where peo­ple feel they have been bul­lied into tak­ing statins. Peo­ple have told me of their doc­tors be­ing dis­mis­sive of the side ef­fects, and blam­ing symp­toms on sim­ply get­ting old.

Other med­i­cal pro­fes­sion­als seem blink­ered by links be­tween heart dis­ease and choles­terol, ig­nor­ing other sig­nif­i­cant causes such as stress, nutri­tional im­bal­ances and en­vi­ron­men­tal fac­tors such as pol­lu­tion. There are also a num­ber of stud­ies sug­gest­ing that statins, para­dox­i­cally, could be bad for the heart. It is al­ready known that they block the pro­duc­tion of a sub­stance called coen­zyme Q10; a crit­i­cal com­po­nent in the pro­duc­tion of cel­lu­lar en­ergy and some­thing the heart, in par­tic­u­lar, has high re­quire­ments for.

So, are statins over­pre­scribed? Those in favour of their mass use of­ten sug­gest that op­po­nents are on the fringe of med­i­cal opin­ion.

How­ever, Prof Sherif Sul­tan, pres­i­dent of the In­ter­na­tional So­ci­ety for Vas­cu­lar Surgery, takes part in a de­bate about statins at the VEITH sym­po­sium in New York, each year. He strongly be­lieves that statins should not be given to peo­ple who do not have a di­ag­nosed heart prob­lem – re­duc­ing their pre­scrip­tion by around 75 per cent.

Dr Rita Red­berg, a car­di­ol­o­gist and pro­fes­sor of clin­i­cal medicine at the Univer­sity of Cal­i­for­nia in San Fran­cisco, and ed­i­tor-in-chief of JAMA In­ter­nal Medicine, has also ques­tioned the use of statins for those of low risk, be­liev­ing the harm may out­weigh the risk for mil­lions.

De­bate rages on, as pre­scrip­tions for statins con­tinue to be doled out. The one thing we can con­clude for cer­tain is that ev­i­dence is stack­ing up for an ur­gent in­de­pen­dent re­view.

‘Peo­ple have felt bul­lied into statins – and ig­nored when they voiced con­cerns’

 ??  ?? Big busi­ness: global choles­terol­low­er­ing in­dus­try is worth £15 bil­lion – and grow­ing
Big busi­ness: global choles­terol­low­er­ing in­dus­try is worth £15 bil­lion – and grow­ing
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