The Collison Newsletter

November 2005

      POLYMEAL versus POLYPILL *

        

   

The PolyPill: Concept

 

“A Strategy to reduce cardiovascular disease by more than 80%”is the title of a paper by Professors Nicholas J. WALD and Malcolm R. LAW in the British Medical Journal, 28 June 2003 (326:1419)

In this publication, these two researchers made a controversial proposal that everybody over the age of 55 should be given a pill every day to reduce the risk of heart disease and strokes. A wonder pill that could slash the rate of deaths from heart attack or stroke by over 80 percent.

It is called the Polypill. A combination of pharmaceutical ingredients.

 

The PolyPill: Objectives

 

The objectives, as set out by the professors, were to determine the combination of drugs and vitamins, and their doses, for use in a single daily pill, to achieve a large effect in preventing cardio-vascular disease with minimal adverse effects.

The strategy was to simultaneously reduce four cardiovascular risk factors, regardless of pre-treatment levels. The four risk factors that are to be treated by the Polypill are:

• low density lipoprotein cholesterol
• blood pressure
• serum homocysteine
• platelet function.

There are many other cardiovascular risk factors, ie things which increase the risk of possible heart attacks (coronary occlusion) and/or strokes, which are not addressed in this strategy (the Polypill). Other risk factors include: family history of cardiovascular disease, smoking, overweight/obesity, lack of exercise and menopause.

 

The PolyPill: Design

 

To arrive at the specific pharmaceutical drugs and the dose, Wald and Law quantified the efficacy and adverse effects of the proposed formulation from published meta-analyses of randomised trials and cohort studies. Over 750 trials, involving 400,000 people, were assessed. 

 

The PolyPill: Outcome

 

The outcome measures that were calculated from the reviewed data were:

• proportional reduction in ischaemic heart disease (IHD) events and strokes
• life years gained
• prevalence of adverse effects.

What, then, are the 'ingredients' or 'components'of the Polypill?

 

The PolyPill: Results

 

From the meta-analysis, the formulation which met the researchers’objectives was:        

• a statin (for example atorvastatin (10mg) (Lipitor in Australia) or simvastatin (40mg) (Zocor in Australia)) to lower cholesterol
• three blood pressure lowering drugs (for example: a thiazide, a ß blocker and an angiotensin converting enzyme inhibitor) each at half the standard dose;
• folic acid (0.8 mg) to lower homocysteine blood levels
• aspirin (75mg) to decrease platelet stickiness.  

Wald and Law estimated that the combination (which they called the Polypill) would reduce IHD events by 88% (95% confidence interval 84% to 91%) and stroke by 80% (71% to 87%). One third of people taking this pill from age 55 would benefit, gaining on average about 11 years of life free from IHD event or stroke.

It was estimated, by summing the adverse effects of the components observed in the randomised trials analysed, that the Polypill would cause symptoms in 8-15% of people, depending on the precise final formulation. 

The ethical problems associated with medicating healthy people, who do not need drugs, is a dilemma not addressed in detail.

However Professor Nicholas Wald is on record as saying the Polypill could potentially save 200,000 lives every year in the UK alone. “There’s probably no other preventative measure which would have greater impact on public health in the Western world.”. Professor Wald is research leader and an expert in preventive medicine at the Wolfson Institute of Preventive Medicine, London. He also said that the Polypill could be produced cheaply, as the patents on many of the components have expired or will do so soon (2003).  Professor Wald also believes that age is a more powerful predictor of cardiovascular disease than the risk factors usually considered. “In Western Society, the risk factors are high in us all, so everyone is at risk. There is much to gain and little to lose by the widespread use of these drugs.”.

In general, the medical community is said to have welcomed the concept of the Polypill, but have questioned the potential adverse effects (especially in apparently well and asymptomatic people), as well as the ethics as mentioned above and the costs of such an intervention.

Too good to be true?

Is this not another example of a ‘disease’(coronary risk) being created, thus requiring drug treatment? This whole topic is addressed in two  recent books:

• ‘Selling Sickness’by Ray Moynihan and Alan Cassels (published by Nation Books 2005). This book tells ‘How the world’s biggest pharmaceutical companies are turning us all into Patients’.
• ‘The Truth About the Drug Companies. How They Deceive Us and What To Do About It’by Marcia Angell MD (published by Random House 2004).

Let food be your medicine –not pills.

 

The Polymeal: Concept

 

Inspired by the concept of the Polypill, Oscar H. FRANCO and co-workers sought to identify a safer, tastier and non-pharmaceutical alternative to the Polypill, which they have named the Polymeal.

“The Polymeal: a more natural, safer and probably tastier (than the Polypill) strategy to reduce cardiovascular disease by more than 75%”is the title of their paper. It was also published in the British Medical Journal, 18 December 2004 (329:1447).

 

The Polymeal: Ingredients

 

Like the research into the Polypill, data on the ingredients of the Polymeal was taken from the literature, ie published evidence, to justify the recommended diet and the therapeutic outcomes.

The evidence based recipe includes:

• fruits and vegetables
• almonds
• wine
• fish
• garlic
• dark chocolate.

 

The Polymeal: Design

 

Data from the Framingham heart study and data from the Framingham offspring study were used to build life tables to model the benefits of the Polymeal in the general population from age 50, assuming multiplicative correlations.

The evidence based diet conceptual framework, used by Franco and co-workers, follows similar principles to evidence based medicine. The constituting elements of a meal or recipe were selected on the basis of the best available evidence, and the evidence available for each ingredient was graded according to the level of evidence. To be included in the Polymeal, the ingredient had to have individually reported effects (not as an element of the diet) on reduction in cardiovascular disease events or modification of risk factors for cardiovascular disease.

 

The Polymeal: Results

 

The following is a summary of the results.

• Fruit and vegetables were shown to reduce blood pressure, as was dark chocolate
• Garlic and almonds were both identified as reducing cholesterol
• Wine and fish both reduced cardiovascular disease.

The amounts of these foods required, and their relative reductions in cardiovascular disease (CVD) were:

Food	Amount	Reduction in CVD
Fruit and vegetables	400gm per day	21%
Dark chocolate	100gm per day	21%
Garlic	2.7gm per day	25%
Almonds	68gm per day	12.5%
Wine	150 ml per day	32%
Fish	114gm 4 times per week	14%

The combined effect of the above ingredients of the evidence based Polymeal was calculated by multiplying their correspondent risk estimates. This was the same method that was used for the Polypill. The authors selected total cardiovascular disease as the outcome (and not coronary heart disease and stroke separated) on the basis of current recommendations in the European guidelines on cardiovascular disease prevention.

Combining all the ingredients of the Polymeal resulted in cardiovascular disease being reduced by 76% (95% confidence interval 63% to 84%).

It was uncertain whether increasing the amount of each ingredient would increase the effect of the Polymeal. On the other hand, decreasing the quantities, or omitting one or more ingredients, could be expected to reduce the effects of the Polymeal.

For men, the Polymeal would result in an increase of 6.6 years in total life expectancy and 9.0 years in life expectancy free from cardiovascular disease. The reductions were similar for women (4.8 years total life expectancy and 8.1 years without cardiovascular disease).

No proven serious adverse effects were reported in any of the publications selected.

Thus the Polymeal is an effective, natural, safer and tastier alternative to the Polypill to reduce cardiovascular disease and increase life expectancy in the general population. The effect was consistent in both men and women at age 50.

The authors of the Polymeal also make the following suggestions:

• Garlic is reported to cause malodourous breath and body odour. As the Polymeal is destined for mass treatment, it is suggested that few people would notice the garlic odour after a while. No additional adverse effects should be expected from the other ingredients of the Polymeal, except in people who are allergic to the components.
• It is important that consumption of alcohol should not exceed the amount recommended in the Polymeal in order to avoid intoxication and also because excess could negatively influence other health measures.
• Other ingredients that could be added to the Polymeal, and could further improve its effect on cardiovascular disease reduction, include: olive oil, soy oil, soya beans, tomatoes, oat bran, cereals, other nuts, tea and chickpeas. For example, oat bran has a cholesterol-lowering effect due to binding, and hence excretion, of bile salts. Replacement bile salts are formed from cholesterol.

It should be noted that both the Polypill and the Polymeal analysis, as carried out by the different authors, used a similar approach.

In Western society, we all have cardiovascular risk factors, so everyone is at risk, and the diseases they cause (cardiovascular disease includes angina, coronary insufficiency, myocardial infarction (heart attack), congestive heart failure, stroke, transient ischaemic attack and intermittent claudication) are common and some fatal. The Polypill may be slightly more effective but, as Franco and co-workers state, the Polymeal “promises to be an effective, non-pharmacological, safe and tasty alternative for reducing cardiovascular morbidity and increasing life expectancy in the general population”.

Comments

 

This newsletter unreservedly and adamantly rejects the idea of the Polypill. All pharmaceutical drugs are poisons. All pharmaceutical drugs are highly acid forming in the body. Drugs are a ‘quick fix’. This reality is addressed in the article ‘Feeling Worse before Feeling Better’(see the home page of this website).

The Polymeal is an attempt to achieve the same benefits as the Polypill gives by adding into, or modifying, the appalling typical Western diet by the addition of seven foods shown to have beneficial effects on cardiovascular health.

My book ‘How to Live to 100+ Years free from Symptoms & Disease’(see the home page of this website) presents in detail the dietary guidelines to ensure ongoing health and prevent, or at least delay, the development of disease, including cardiovascular disease.

These dietary guidelines cover both what not to eat, as well as what to eat, and how to eat it. The guidelines present a total diet. And, yes, it is difficult to change from the illness and disease causing typical Western diet. But it can be done, and this lifestyle change is, or should be, the goal of everyone to achieve, and should be the highest priority.

With reference to the components of the Polymeal:

• Fruit and Vegetables. The dietary guidelines in ‘How to Live to 100+ Years free from Symptoms & Disease’include a high intake of both fruit and vegetables (1200gm - 1750gm per day), which is significantly more than the 400gm per day recommended in the Polymeal. The goal of having 75% - 80% of our food intake to be alkaline forming is the basis of the ideal diet, and this can only be achieved with a high intake of both fruits and vegetables. Refer to my September 2005 Newsletter on acid/alkali balance.
• Dark Chocolate. This chocolate is high in sugar, and contains caffeine as well as dairy product. It is possible that, due to these ingredients, the benefits on cardiovascular health would be outweighed by other adverse, long-term effects which could include diabetes and osteoporosis. The latter is discussed in detail in chapter 10, ‘Dairy Products, Osteoporosis and Calcium’, in ‘How to Live to 100+ Years free from Symptoms & Disease’.
• Garlic. Garlic is not so much a food as a supplement with the drawback of unpleasant body and breath odour. The antioxidant Vitamin C (1000mg per day) (combined with bioflavinoids) would give significant protection against free radical damage, which is a factor in cardiovascular disease. A supplement of psyllium powder, again not a food, would assist in lowering blood cholesterol by binding bile salts (similar to oat bran). Regarding garlic as a supplement, the alternate supplements of vitamin C (with bioflavinoids) and psyllium will give at least equivalent, and probably greater, benefits.
• Almonds. Of the nuts, almonds are alkaline forming. The dietary guidelines in ‘How to Live to 100+ Years free from Symptoms & Disease’recommend no more than 25gm nuts per day, significantly less than the 68gm per day recommended in the Polymeal. 
• Wine. Wine is between 8% - 12% alcohol. The Polymeal recommends 150 ml wine per day, which would be between 1.2 and 1.8 standard drinks (a standard drink is 10 ml alcohol) per day. Literature suggests that up to 7 standard drinks per week is the level giving a health benefit. The polymeal is slightly in excess of this.
• Fish. The dietary guidelines in ‘How to Live to 100+ Years free from Symptoms & Disease’present a low fat diet, with a minimal intake of all foods of animal origin. If animal products are to be consumed, “no legs is better than two legs is better than four legs”is the suggested guideline. Fish, 114gm 4 times per week as recommended in the Polymeal, would fit into the 20% - 25% of the diet that can be acid forming (all animal products are strongly acid forming).

The dietary guidelines in ‘How to Live to 100+ Years free from Symptoms & Disease’aim to result in a Body Mass Index (BMI) of between 20-25, with the ideal being in the region of 21. With well over 50% of people on the typical Western diet now overweight (BMI of 25 or greater) or obese (BMI of 30 and above), the greatest single thing these overweight people can do is to lose weight towards a BMI of 21: this will significantly reduce cardiovascular disease risk as well as protect from other diseases, including cancer.

 

In Summary

 

The concept of the Polymeal is vastly superior to the Polypill.

The ideal way forward, however, must centre on lifestyle change:

• diet as per the dietary guidelines in ‘How to Live to 100+ Years free from Symptoms & Disease’
• weight reduction aiming for the ideal BMI of less than 25, towards 21
• exercise
• cessation of smoking
• as well as adequate rest, stress management and a positive attitude.

 

* Copyright 2005: The Huntly Centre.