Health Supreme by Sepp Hasslberger

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July 23, 2003

"Polypill" insanity again

I reported on the insane proposal of a hypothetical "polypill", a combination medication with several diverse pharmaceutical drugs all mixed into one, at the time it was floated by the British Medical Journal. All this proposal shows is the depth of desperation of pharmaceutical companies for an increase in business and their profound disregard for people's health and lives.

Paul Rosch, MD, FACP, a clinical professor of medicine and psychiatry at New York Medical College and President of the American Institute of Stress, as well as Honorary Vice-President of the International Stress Management Association, has written a cogent comment, first published in Red Flags Weekly, wich I would like to make available here.

Play with the figures of relative vs. absolute risk reduction and you will be able to show seemingly huge effects. But also look at the very concept (and contents) of placebos, and you will see that to call this the "poly pill insanity" is by no means an exaggeration.


By Paul J. Rosch, MD, F.A.C.P.

Paul Rosch, MD, FACP, is clinical professor of medicine and psychiatry at New York Medical College and is President of the American Institute of Stress, and Honorary Vice-President of the International Stress Management Association.

This column will also appear in a future edition of the Health and Stress monthly newsletter of the American Institute of Stress

Forget about the alchemist's magical "Elixir of Life" and Ponce De Leon's "Fountain of Youth". These fantasies have recently been replaced by a combination pill concocted not by some "kook", but two distinguished scientists, Nicholas Wald, Professor and Head of the Wolfson Institute of Preventive Medicine in London and Malcolm Wald, a Professor at the University of London and University of Auckland in New Zealand. These researchers believe they can prevent almost nine out of ten heart attacks as well as four out of five strokes in anyone with cardiovascular disease and everyone age 55 and older. All you need to do is to take their powerful Polypill daily.

So what's in this latest magic bullet? A statin to lower LDL, three different antihypertensive drugs (a beta blocker, diuretic and ACE inhibitor), aspirin to reduce clotting tendencies and folic acid to prevent high homocysteine levels. There is no vitamin C or vitamin E, omega-3 fatty acids, Coenzyme Q10 or other ingredients that have also been shown to reduce heart disease. There are no dietary restrictions or recommendations nor any apparent need to exercise more or stop smoking.

The Polypill was introduced with much fanfare in a lead article entitled "A strategy to reduce heart disease by more than 80%". It appeared in the June 28 issue of the British Medical Journal accompanied by two enthusiastic editorials. Richard Smith, the editor, started out by stating that this was possibly the most important issue of the journal in the last 50 years. He suggested that everyone save their copy since it would likely become a collector's item. A guest editorial by Anthony Rogers, co-director of the Clinical Trials Research Unit, University of Auckland was not quite as gushy. However, it also seemed to endorse the authors' claim that the Polypill would have "a greater impact on the prevention of disease in the Western world than any other known intervention"! Not surprisingly, the professors filed a patent application for their formulation and a trademark application for the name Polypill over three years ago

Their contention is that one in three people over the age of 54 could look forward to an additional 11 or 12 years of life free from cardiovascular disease by taking a daily Polypill. All the ingredients are readily available and not protected by patent so the price of the pill would be minimal, especially when purchased in huge quantities. There is apparently little concern about safety because of the relatively low dosages of the various drugs, which apparently does not reduce their effectiveness.

These conclusions seem somewhat premature, if not preposterous, for several reasons. The first is that no studies have ever been done with the Polypill since it does not exist. It is not clear if this will be manufactured as a tablet, capsule containing powder or gelcap, and the various different fillers required or formulation of the covering may not be compatible with all the constituents. Proximity to meals and time of day of administration may influence efficacy. Simvastatin and beta blockers are more effective when given in the evening, but a thiazide diuretic taken at the same time could significantly interfere with a good night's sleep. Some of the ingredients have significant side effects or are relatively contraindicated in common conditions like diabetes and asthma. In addition, desired responses may be suppressed and/or unwanted actions augmented when certain of these drugs are taken simultaneously.

The claims for efficacy and safety of the Polypill are based solely on meta-analyses and statistical evaluations of more than 750 clinical trials involving some 400,000 participants. Many of these study groups involved individuals with evidence of or at increased risk for coronary heart disease and hypertension. Extrapolation of such results to populations with no increased risk for cardiovascular disease other than having reached the age of 55 seems unwarranted and potentially dangerous. They hardly justify converting millions of healthy people into perpetual patients, some of whom may well develop complaints like chronic cough and bleeding tendencies. The promises that 88% of heart attacks and 80% of strokes will be prevented are based on statistics that reflect relative risk reduction, which is very different than absolute risk reduction. This is a great example of Harry Truman's advice, "If you can't convince them, confuse them".

For example, your doctor tells you that there is a new blockbuster statin drug with no side effects and if you take it every day for the next five years it will significantly "reduce your risk" of heart attack. How likely is it that you would take the drug based on the following clinical studies?

1. Over five years, patients taking this drug had 34% fewer heart attacks compared to controls who took a placebo. (Sounds pretty convincing)
2. Over five years only 2.7% of patients taking this drug had a heart attack compared to 4.1% taking a placebo. (Also not too bad)
3. If seventy-one people take this drug every day for five years it will prevent one of them from having a heart attack. However, there is no guarantee that you will be that person. (These odds are not very attractive)

All these scenarios are accurate and are based on the same data but the statistics have been presented in very different ways. To avoid becoming confused, it is essential for you to be able to distinguish between relative risk reduction, absolute risk reduction and number-needed-to-treat.

Scenario 1: 4.1% taking the placebo had heart attacks; compared to only 2.7% for those taking the drug, a Relative Risk Reduction of 34%.

Scenario 2: When you compare the percentage of the 4.1% in the placebo group who had heart attacks with the 2.7% of statin-takers who had heart attacks, the Absolute Risk Reduction is only 1.4%!

Scenario 3: How many people need to take the drug to prevent just one heart attack? Your doctor would have to treat 71 people just like you for five years to prevent one of them from having a heart attack but there is no way of knowing who this will be. This is called the Number Needed To Treat and would probably not persuade many healthy patients to take this pill for the rest of their life.

Statin manufacturers are able to persuade physicians to prescribe their products by citing Relative Risk Reduction statistics and these are also featured in direct advertising to consumers, who may not be aware of their true significance. The fact is that none of the primary prevention statin trials have demonstrated a decrease in overall mortality rates and most show no significant decrease in the incidence of heart attacks or strokes. The Polypill proponents have done the same thing. Many will interpret their claims to mean that taking a pill every day for the rest of their lives will reduce the likelihood of having a heart attack by 88 per cent and lower their chances for stroke by 80 per cent. If the meta-analyses statistics were reported instead as Absolute Risk Reduction percentages and Number Needed To Treat, quite a different picture would be painted. According to a rapid response posted on the BMJ web site by two British physicians entitled

"Patients Before Populations"

"We are duty bound to inform our healthy 55-year-old that if he or she takes the Polypill for the next 10 years there will be less than 1% chance per year of benefit and a 6% overall chance of side effects, some of which (e.g. aspirin related GI haemorrhage) may be life threatening. Furthermore if the Polypill is successful, our patient's chance of dying from cancer, trauma and degenerative brain disease will increase pari passu with the effectiveness of the Polypill, as sadly even on the Polypill, mortality will remain stubbornly around the 100% mark."

Not mentioned were the possible adverse effects of statin induced Coenzyme Q10 depletion, beta blocker fatigue and impotence, etc. The selection of three antihypertensive drugs at "half standard doses" shotgun approach is based on the erroneous premise that most patients will eventually require three or more medications to achieve satisfactory blood pressure control. It also assumes that this particular combination will provide a satisfactory synergistic effect while significantly reducing individual side effects. Calcium channel blockers were apparently excluded to keep costs down but they can also conflict with thiazides. However, beta blockers may deplete levels of Co Q10 and potentiate other adverse statin side effects like fatigue. There could be additional complications from unanticipated interactions between the constituents of this crazy concoction.

Extrapolating the results from epidemiologic studies of large populations to treat individual patients is dangerous, especially when based on meta-analyses of groups that may not be relevant. This approach also ignores comorbidity problems due to other conditions that may affect metabolism and excretion or require conflicting medications. A good example of this is the current confusion about treating elevated blood pressure, which is also usually a trial and error buckshot approach. A bullet will do the trick, since 60% of all hypertensive patients can be controlled on one medication permanently by renin profiling to determine whether the problem is salt (volume) related or due to activation of the renin-angiotensin-aldosterone system. As will be explained in a subsequent article, this testing is now readily available. Until then it would be wise to heed the "Patients Before Populations" advice of other Polypill critics.

Found on REDFLAG

883As a counterpoint, here a recent article in The Guardian. It seems that food may be more effective and have less side effects than a combination of pharmaceuticals...

How to live longer: a Polymeal a day

Sarah Boseley, health editor
Friday December 17, 2004
The Guardian

Never mind the tablets - heart disease could be cut by 76% and men could expect to live more than six years longer if they simply ate the right meal once a day, doctors said yesterday.

Last year the British Medical Journal ran a paper advocating the "Polypill" - combining aspirin, folic acid and cholesterol-lowering and blood-pressure drugs - for everybody over 55. But an article in the Christmas issue says a "Polymeal", containing fish, wine, dark chocolate, fruits and vegetables, garlic and almonds, would achieve roughly the same effect.

Men on the Polymeal would increase their life expectancy by 6.6 years and women by 4.8 years, say the authors, Oscar Franco and colleagues from the department of public health at Erasmus University in Rotterdam.

"The Polymeal promises to be an effective, non-pharmacological, safe and tasty alternative [to the Polypill] for reducing cardiovascular morbidity and increasing life expectancy in the general population," they write.

The doctors searched medical literature to find foods that have been proven to lower the risk of heart disease. Drinking 150ml of wine a day cuts the risk by 32%, they say, and fish consumed four times a week reduces it by 14%. A daily intake of 100g of dark chocolate and 400g of fruit and vegetables lower blood pressure, further cutting the risk of heart disease. Garlic and almonds both lower cholesterol levels. The daily Polymeal contains 2.7g of garlic and 68g of almonds.

"Combining all the ingredients of the Polymeal resulted in cardiovascular disease being reduced by 76%," they write. "Whether increasing the amount of each ingredient would increase the effect of the Polymeal is uncertain. On the other hand, decreasing the quantities could be expected to reduce the effects of the Polymeal."

Men would not only have a longer life expectancy, but also live nine years longer without heart disease, while women would be free of it for eight years longer.

The Polymeal has no serious side-effects, they say, in contrast to the Polypill. But they do note: "Fish consumed in larger amounts than recommended as part of the Polymeal has been related to raised blood mercury concentrations, especially with large fish such as shark and swordfish."

There are issues around garlic, but not in the long term. "Adverse effects reported for garlic include malodorous breath and body odour. As garlic is destined for mass treatment, few people will still notice this after a while," they say.

However, they add: "We do not recommend taking the Polymeal before a romantic rendezvous, unless the partner also complies with the Polymeal."

The Polymeal can either be eaten as an entire meal - a recipe by the chef Raymond Blanc suggests watercress soup, grilled fillet of mackerel with a tagine of winter root vegetables, chickpeas, toasted almonds and roasted garlic, followed by chocolate mousse - or the ingredients can be eaten separately during the day, say the doctors.

They warn that the Polymeal should not be taken with excess alcohol, to avoid compromising the health benefits and "in order to avoid intoxication and conflicts with friends, relatives and authorities".

Online version of the study: The Polymeal: a more natural, safer, and probably tastier (than the Polypill) strategy to reduce cardiovascular disease by more than 75%


posted by Sepp Hasslberger on Wednesday July 23 2003
updated on Tuesday December 21 2010

URL of this article:


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