26/08/2012 16:26 BST | Updated 26/10/2012 06:12 BST

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

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.