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Aidan Goggins

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The Polyproblems of the Polypill - Why it is Now Destined for Failure

Posted: 27/08/2012 00:00

Regular readers through HealthUncut and The Health Delusion will be aware that I take serious contention with the increasing obscurity of the boundaries between preventive medicine and medicating society, no more aptly illustrated than by the polypill.

For those not familiar with the polypill, it is the proposal that an en mass drugging with a combination of four cardiovascular medicines (aspirin for clots, a statin for cholesterol and two blood pressure medications) will be a panacea for our cardiovascular disease woes. It will be a universal drugging of the population, the only criterion is age, and all you have to do is reach your 50th birthday to join the club.

Up to now, we have explored two major flaws in the polypill which alone ensure it is destined to go down in the annals of history as a monumental failure.

First, is the litany of side effects, affecting as many as 20% of consumers from the statin component alone[1]. These include muscle related adverse effects, memory loss and confusion, elevated liver enzymes and type-2 diabetes. The reality is that the side effects are so bad, that the two year adherence rate to statin therapy in individuals without cardiovascular disease is as low as 25%. That's before we even begin to account for the sizable side effect profile the other three drugs possess.

Second, is the false sense of security that supposed 'immunity' to heart disease would bring. Let's face it, if we were exempt from speeding tickets when driving a lot of us are going to drive faster. Become 'exempt' from heart disease and the same concept applies. Healthy living becomes marginalised. Why bother with the exercise, healthy eating, stopping smoking and cutting alcohol etc when you have a pill to protect you. Ok, you may not get heart disease, but you will be on track for a head on collision with any number of other chronic diseases.

And now, true to the spirit of keeping the best till last, last week brought the revelation of another dimension to the debate to (hopefully) put the final nail into the coffin of the polypill. The drugs do not work!

A new review of almost 9,000 patients by the esteemed Cochrane Collaboration found that pharmacologically lowering blood pressure in individuals with moderately raised blood pressure (140-159 mmHG/ 90-99 mmHG) in individuals with no previous history of cardiovascular disease - the exact population the polypill is designed to target - confers absolutely no benefit [2]. No reduction in deaths, no reduction in coronary heart disease, and no reduction in stroke. The only thing that gets healthier by us taking these drugs is the coffers of the pharmaceutical industry.

So convincing was the evidence that these drugs do not work David Cundiff, one of the reviewers, suggested that patients, "throw away their blood pressure pills and focus instead on far more effective as well as evidence based approaches, such as exercising, smoking cessation, and eating a DASH (diet against systolic hypertension) or Mediterranean diet" - under a doctor's guidance of course [3].

US expert Professor Jerome Hoffman was unfazed by the findings stating "we've long known that...efforts to lower BP to 'normal,' typically requiring multiple drugs, are not only usually unsuccessful but produce more harm than good, since adverse effects of intensive treatment outweigh the minimal marginal benefit of a little more BP 'control'" [3].

Yet, it was just a mere few weeks ago when the bubbly corks popped as the latest polypill trial results came out, proclaiming an overwhelming victory in the battle against heart disease, with a massive 72% and 64% reduction in ischemic heart disease and stroke respectively[4]. A clear contradiction in terms, why the discordance?

Well, here we fall privy to the unmasking of a favourite trick of the pharmaceutical industry, an illusion that David Copperfield himself would be proud of. Whilst the Cochrane review followed study participants for five years and actually measured real health outcomes, the polypill study lasted just 12 weeks and used what are called surrogate markers. Basically, what this means is they measured outcomes such as blood pressure and cholesterol changes, and used ad hoc mathematical models to estimate and extrapolate its impact on health.

And that's all it is, guesswork. Scrutinise under the illuminating light of the far more rigorous and relevant Cochrane study and the polypill victory loses its fizz awfully quickly, as we see just how incredibly wrong the study authors got it.

Smoke and mirrors, the truth behind 'the great polypill', each un-medicated individual simply an untapped resource to the pharmaceutical industry. For we live in the era of medicine creep, a generation where healthy lifestyle and root causes have been relegated to an inconvenience, and Big Pharma are more than willing to endorse this perilous and short-sighted philosophy.

It's now three strikes against the polypill, the question remains: will the pharmaceutical industry accept that it's game over? Call me cynical, but somehow I doubt it. However, with now indisputable evidence against the polypill we the public must accept its unmitigated failure.

1. Maningat, P. and J.L. Breslow, Needed: pragmatic clinical trials for statin-intolerant patients. N Engl J Med, 2011. 365(24): p. 2250-1.
2. Diao, D., et al., Pharmacotherapy for mild hypertension. Cochrane Database Syst Rev, 2012. 8: p. CD006742.
3. Lenzer, J., Cochrane review finds no proved benefit in drug treatment for patients with mild hypertension. BMJ, 2012. 345: p. e5511.
4. Wald, D.S., J.K. Morris, and N.J. Wald, Randomized polypill crossover trial in people aged 50 and over. PLoS One, 2012. 7(7): p. e41297.

 
 
 

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15:18 on 28/08/2012
My late wife (a nurse), suffered from malignant hypertension for a period of 8 years up to her death in 2007. The first course of treatment being by beta blockers and a thiazide diruretic, these drugs only managed to keep her bp down to reasonable levels for periods of a few months, whence it would once more rise! Her GP merely titrated the dosages, until she could not function, as the levels of the beta blocker were interfering with her flight and fight mechanism!

When we discussed with him the results of the Anglo-Scandinavian Cardiac Outcomes Trial, which recommended duo drug therapy using an ACE inhibitor and a calcium channel blocker. Their results showing a 23% improvement in cutting the risks of stroke, 13% better for coronaries and 24% more effective in reducing cardio-vascular deaths!

He merely poo-pooed the idea as being too costly! , and refused! Instead merely continuing to titrate the doses of the beta blocker and diuretic! Unfortunately, my wife had ultimate faith in her GP and paid the ultimate price!

There are combined pills available now and they are useful in some cases. But to combine several more into a "polypill" may cut costs ultimately, they are not the answer!
14:00 on 27/08/2012
This is frightening. Why isn't the media doing more to highlight this insted of hyping up the prince harry thing?
11:23 on 27/08/2012
This article should be on the front page of all our national newspapers and headline all TV news programs. My concerns are that in the pursuit of corporate greed our politicians and large corporations are "all in it together" to dupe the public into taking these meds alongside ingesting multiple other concoctions which actually make one fat and ill and the general public are so gullible they swallow the propaganda. No doubt your audience will be limited to huffpo and the sheeple keep taking the meds instead of living their lives to the full, doctors will keep pushing these drugs and dementia and other illnesses will continue to be an increasing, self imposed "problem" with no other cause according these parasites but age.
08:52 on 27/08/2012
There are millions out there with illnesses caused by the use of statins, i am one of them, consultant and GPs were only interested in their targets for cholesterol not in the wider implications. I started statins as they told me changing my diet would have no difference. I went to them stating i felt weak, mentally and phisically slower GPs said it was stress and depression and wrote another prescription for another tablet. I refused to take the depression tablets and asked for full bloods, they finally relented and phoned me the same day to say stop taking the statins as it was killing me. Muscle wasting enzymes through the roof, liver through the roof, testosterone through the floor etc. I am now on treatment for the rest of my life, i believe i am lucky compared to some who i believe have died sooner than they would have done because of these tablets and the liver changes they cause. this pill will be another money spinner for the medical system as the growth of evidence against statins increases. people need to be aware that GPs, Consultants etc are all part of the business and increasingly rely on money and perks from these firms.
11:33 on 27/08/2012
Glad you realized before it was too late, I had a pretty immediate reaction to statins and looked them up thoroughly, I only went to the doctors about arthritis in my knees and these tablets and painkillers were the outcome, neither of which I take. After my refusal to take them again on my next doctors appointment at the "well man" clinic the first thing I noticed as the quack got my records up was a banner on the page announcing "Refuses statins", I wonder how many over fifties are swallowing this garbage daily and are on their way to a life in a care home due to medical incompetence in these areas.
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Aidan Goggins
12:00 on 27/08/2012
"I wonder how many over fifties are swallowing this garbage daily and are on their way to a life in a care home due to medical incompetence in these areas."

- If we use US figures (often a lot more forthcoming that the UK) we see one in four individuals over 45 are on statin therapy. Pretty incredible!