A Spanish friend who is a pharmacist and basic scientist and with whom I have a spirited argument over the polypill has emailed me to gloat over the press reports derived from a Cochrane review that statins provide no benefit for healthy people. She believes that healthy living will suffice for fending off heart attacks and strokes and that the polypill is a dangerous delusion.
Friends like her think me very confused in that I’m rejoicing in finally taking the polypill seven years after praising it to the heavens in the BMJ but am at the same time a prophet of demedicalisation, contributing to a proposed television programme on “The town that gave up medicine,” a guzzler of porridge every morning without either salt or sugar, and well through a month without alcohol and with three runs and 70 000 steps a week.
My enthusiasm for the polypill undiminished by the press reports of the hopelessness of statins for the healthy, I replied hotly to my gloating friend.
Did you actually read the review rather than the press reports? Here are two bits from the abstract:
Fourteen randomised control trials (16 trial arms; 34,272 participants) were included. Eleven trials recruited patients with speciﬁc conditions (raised lipids, diabetes, hypertension, microalbuminuria). All-cause mortality was reduced by statins (RR 0.83, 95% CI
0.73 to 0.95) as was combined fatal and non-fatal CVD endpoints (RR 0.70, 95% CI 0.61 to 0.79). Beneﬁts were also seen in the reduction of revascularisation rates (RR 0.66, 95% CI 0.53 to 0.83). Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects. There was no clear evidence of any signiﬁcant harm caused by statin prescription or of effects on patient quality of life.
Although reductions in all-cause mortality, composite endpoints and revascularisations were found with no excess of adverse events, there was evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease. Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.”
In other words, statins did reduce mortality and CVD events dramatically, as we would expect.
George (Davey-Smith] and Shah [Ebrahim]–two of the authors of the review, both of them friends of mine, paid up iconoclasts, and in the case of George an unreconstructed Trotskyist (or something equally ardently left wing) –draw some dubious conclusions. Let me address these:
1. Selective reporting: sadly this is a fact of life and could be used to undermine confidence in all drug trials because virtually all drug trials are funded by drug companies. Most drug trials have effect sizes much smaller than those that the review reports.
2. Failure to report adverse effects: again this is very common. But RCTs are not the best way to assess side effects because of the relatively small numbers in trials and the short follow up. As you know, millions of people across the world have now taken statins for years and side effects are well known and minimal.
3. Inclusion of people with cardiovascular disease: This phrase is disingenuous as you don’t really “have or not have CVD.” As Geoffrey Rose, the great epidemiologist said, there is no disease that you have or don’t have–apart perhaps from sudden death. Are two people, one of whom has angina and another a 25% risk of a heart attack or stroke in the next 10 years, very different? I think not.
4. Cost effectiveness. That statins are now coming off patent will surely transform this picture. We know that the polypill can be manufactured for as little as a dollar a month.
5. Quality of life. This is absence of evidence rather than evidence of ineffectiveness. The severe deterioration in quality of life comes from having a stroke.
So I don’t think that this review really changes anything.
Competing interest: RS is the unpaid chair of the Cochrane Library Oversight Committee and is taking the polypill as part of a double blind randomised cross over trial after two years of taking the individual drugs. As he’s not getting up to pee at nights he thinks he’s on the placebo.