Abstract
A proposal by Wald and Law (2003) for a single pill containing a statin, three half-dose antihypertensives, aspirin, and folic acid, met with a storm of controversy and seemed to have been relegated as much to the fanciful as to the accolades it might have deserved. The benefits such a Polypill could confer on people age 55+y were to reduce both cardiovascular and stroke events by 80% or more. Considering the daunting and, at best, slow process of changing the same risk factors through health promotion interventions on food policy, dietary and physical activity behaviors, and urban planning to make less prevalent the sedentary lifestyles developed over decades, the argument here is to view the Polypill as a harm reduction strategy that would complement health promotion, as Nicotine Replacement Therapy did for tobacco control, seat belts did for traffic injuries, and needle exchange programs did for secondary complications of injection drug use.
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Acknowledgements
I am indebted to the Planning Committee (co-chaired with William Weintraub and staffed by Andrew Friede and Kristen Copes, the Constella Group, LLD) and the Expert Panel members sponsored by the US Centers for Disease Control and Prevention (especially Venkat Narayan, Michael Engelgau, George Mensah, Frank Vinicor, and David Williamson) to identify issues and to recommend strategies for the testing and development of the Polypill approach in the United States. This paper represents the personal views of the author and not necessarily those of the Committee, the Expert Panel, or the CDC.
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Commentary article for European Journal of Clinical Nutrition as part of special issue from the conference of Heelsum IV, the Netherlands, December 2004.
Abbreviated discussion after Green
Kok: The title of this session is ‘Creating a supportive environment for family doctors and patients’. What is your opinion: could the use of the Polypill contribute to a supportive environment?
Green: Yes. This is an environmental intervention…. Let me put it this way. I think that attention for environmental support to reduce risk factors is worthy of consideration. With tobacco control, it was not until we started addressing environmental factors seriously that we began to have an impact on behavior…. This is only a harm reduction strategy for people aged 55 y and over, so there still is much to be done in other respects. For example, lifestyle education to prevent obesity early in childhood.
Brug: I do not think that this is only an environmental intervention. It is behavior. People need to take those pills. And in the way they are supposed to take it; not take two when they have had a big meal.
Helman: I am worried that studies (on which the Polypill is designed) were not conducted with non-selected over 55-y-old people.
Green: Yes. That is why we have to have an RCT in people over 55 y.
Truswell: I have three additional concerns. First, the pharmaceutical question: Are all these ingredients compatible in one pill? The acid nature of some components might damage some of the other components. Secondly, are we going to see people living 3–6 months longer, and more of them coming to some kind of cancer or Alzheimer's; a lot of older people would prefer to have a brisk stroke or coronary than most cancers or certainly Alzheimer's. And thirdly, this may not save money on health services. People are not going to live forever. They will still have diseases when they are somewhat older.
Becker: I have concerns about the anticipated magnitude of effect. Epidemiological evidence about risks and risk reductions may lead to wrong answers. For instance, from the plasma cholesterol reduction, a 60% reduction in coronary heart disease is expected, but the statin trials only came up with 30%. I do not believe the effects will be additive. If there are multifactorial causes of coronary events, and we interfere at different spots, it may not be at all appropriate to add the effects. For example, if the statins are reducing the circulating LDL levels, folic acid is decreasing the incorporation of the LDL in the plaque, and aspirin is stopping the thrombotic events, then stopping all three will not necessarily have three times the effect of stopping one of them.
Green: You are right. In the following issues of the BMJ, dozens of critical letters have been published concerning this problem. But nobody has yet to my knowledge come up with a way to correct for this.
Laws: The Polypill is not going to address obesity per se, and also obesity works to increase cardiovascular risk and the metabolic syndrome…. and diabetes.
Green: That is true. It does nothing about smoking either, and seat belts. And a list of other things. We will still be fully employed. This a major argument for treating this as a complementary medicine, not as a substitute for lifestyle changes.
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Green, L. Prospects and possible pitfalls of a preventive Polypill: confessions of a health promotion convert. Eur J Clin Nutr 59 (Suppl 1), S4–S9 (2005). https://doi.org/10.1038/sj.ejcn.1602167
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DOI: https://doi.org/10.1038/sj.ejcn.1602167
