BMJ, doi: 10.1136/bmjusa.03090003, (Published 30 September 2003)

As of August 25, 2003, this controversial paper had generated 85 Rapid Responses, which can be read in their entirety at http://bmj.com/cgi/eletters/326/7404/1419. Following are edited excerpts — Editor

Letter

RAPID RESPONSES FROM BMJ.COM

From BMJ USA 2003;September:481

Editor — I am just wondering if the "compelling" observational evidence that lowering serum homocysteine reduces heart disease is as "compelling" as the observational evidence that estrogen did the same thing.

University of Western Ontario, Mount Brydges, Canada. wosmun{at}uwo.ca

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Editor — Even in "high risk" populations, statins failed to reduce overall mortality in ALLHAT, PROSPER and ASCOT while the number needed to treat for 1 year to postpone 1 death in HPS was about 300. These are the last 12 months of statin trials. The concept of all-cause mortality is glaringly missing in the Wald and Law analysis.

Sutton, Canada. vos{at}health-heart.org

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Editor — I have read some rubbish in my time, but this just about takes the biscuit. Let's take this to its logical conclusion and put every drug known to medical science in the water supply. That way we will prevent and cure every disease humanity is subject to.

Or, of course, we could cut mortality by 100% by preventing the most important "risk factor" of them all: being born.

barry{at}second-opinions.co.uk

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Editor — Wald and Law's Polypill is an intriguing proposition. Their calculations are based on pooled data in large populations. While it may be true that age is the single most predictive factor for the development of CVD, within-group variation is likely to be large. Where it may not be possible to separate populations on the basis of multivariate analysis, individuals with low and higher absolute risk can be identified. As epidemiologists, Wald and Law do not have to concern themselves with the difficult matter of dealing with individual patients, some of whom are well informed and may pose searching questions. I suspect that most subjects would not be interested in taking a Polypill in order to reduce the population burden of disease. People are more likely to be concerned with their own individual absolute risk of disease, the treatments which may safely reduce that risk, and the burden of costs they have to incur in order to obtain the benefit. If all those over 55 years are treated, then a large number with low absolute risk will incur no benefit. I propose that the well informed customer would prefer to go for individual risk analysis, a policy that may thwart well intentioned epidemiologists.

Sheffield, UK. erybinski{at}compuserve.com

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Editor — If we were guaranteed never to have an accident or get caught for speeding would we drive slower?

If I could print unlimited money in my attic would I spend less? If a pill is produced to reduce heart attacks by 80% will we exercise more and eat less?

Birmingham, UK. mandy.goldstein{at}bhamchildrens.wmids.nhs.uk

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Editor — While the size of the benefit may be debatable, in the absence of direct trial evidence, the concept of the Polypill is surely correct. The burden of CVD in the UK is explained by the high prevalence of traditional risk factors, which do not differ between those who succumb and those who don't. Lifetime exposure to small excesses of multiple risk factors is the problem and intervention across the whole population is the solution. Of course, this could consist of us all eating fish, riding bicycles, and giving up tobacco, cars, salt, and junk food. But get real. What's easier: reversing societal trends of the last 50 years or popping a cheap once-daily pill that lets you have your cake and eat it (literally)? Wald and Law might consider the benefit of adding metformin to their pill in order to help offset the rise in type 2 diabetes, which will inevitably follow.

Chesterfield Royal Hospital, UK. paul.masters{at}chesterfieldroyal.nhs.uk

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Editor — Compliance with the Polypill in elderly people will be problematic as intolerance to one component will mean that patients stop taking the entire combination, thereby missing out on the beneficial effects of all the other components. The Polypill will never reduce CVD by at least 80%, mainly because people won't take it.

St James's University Hospital, Yorkshire, UK. anitabansal{at}yahoo.com

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Editor — Wald and Law's approach assumes that the effects of the various treatments proposed are additive, yet there is little evidence presented that this is, in fact, the case. Without this assumption it is not valid to multiply the relative risks of the various treatment strategies in order to determine the overall effect of the combined treatments. There may be interactions between the treatments, whereby one treatment may negate the effect of one or more of the other treatments. This could only be determined if comparative trials, with combined treatment arms, had been performed.

Hence, the authors have proposed an interesting hypothesis that deserves to be tested, but they have not provided convincing evidence that their proposed combination of treatments should be adopted into clinical practice.

Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. david.reith{at}stonebow.otago.ac.nz

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Editor — We accept that de facto, secondary prevention and treatment of high risk individuals now means that many patients are routinely prescribed aspirin, a statin, and blood pressure lowering drugs. Wald and Law's suggestion of combining the efficacy of these ingredients into a single drug may be valuable. However, their assumptions and incomplete modeling make it likely that the true benefits are less impressive. Before medicalizing every adult over 55 years of age, we need a greater appreciation of potential benefits and harms for overall quality of life, disease morbidity, and mortality.

t.p.fahey{at}dundee.ac.uk

University of Dundee, UK

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Editor — Following this "magic pill" approach could shift the focus and needed resources away from proven and cost-effective CVD prevention strategies, and could well have adverse consequences, especially for developing countries.The most sustainable way forward for prevention and control of the CVD epidemic in developing countries is to scale-up secondary prevention of those with established CVD and target those at high risk with cost-effective population-based interventions. This includes shifting health care towards proactive systems, which emphasize health across a lifetime, and introducing self-management and prevention support as core components of clinical care. We do not believe the strategy proposed by Wald and Law is an adequate response to the growing global burden of chronic diseases.

yachd{at}who.int

Noncommunicable Diseases & Mental Health, World Health Organization

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Editor — Wald and Law state there is a potential for the Polypill to greatly reduce CVD, maybe by as much as 80%. They seem to have missed the point, as others do, with a lot of this research, in that different therapies do not so much prevent as delay disease, as we all have to die of something (as well as pay taxes).

It has been shown in cancer epidemiology that if cancer were cured tomorrow the average life span would increase by only 3 years. One could assume that this will be the case with the Polypill also.

Belfast, UK. g.burns{at}p060.gp.n-i.nhs.uk

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