Researchers claim their research shows  that everyone over 50 should take the Polypill. Those researchers, though, hold the patent on the Polypill. Is their study valid?

by Heidi Stevenson

A new study purports to show that everyone over age 50 needs to take a certain pill to keep from dying young. The media is jumping all over it, with headlines like:

• Polypill ‘could save thousands’ of lives (BBC)
• First Polypill Trial in People Selected On Age Alone (50 and Over) Shows Substantial Health Benefit (Science Daily)
• Polypill Could Dramatically Cut Heart Attacks And Strokes (Medical News Today)
• Daily pill shown to reduce heart risk (Irish Times)
• Health impact of Polypill could be huge (UPI)
• All over 50s ‘should be offered polypill’: Four-in-one drug could extend life by 11 years and prevent thousands of strokes and heart attacks (Daily Mail)

Looking at the popular press and science headlines, you’d think that the Polypill is the fountain of youth, that it’s a nutrient you must have or die.

The Miracle Pill

The product—not yet approved for market—is the Polypill, a single tablet that’s a combination of drugs, which purportedly prevent heart disease. Even individually, they don’t extend life, but that doesn’t appear to be a concern for the researchers involved. You see, the lead authors, Nicholas J. Wald and David Wald, are the co-patent holders for the polypill. They designed the study, Randomized Polypill Crossover Trial in People Aged 50 and Over, and they were responsible for all aspects of its operation.

How the Study Was Gamed

When the goal of a study is to obtain a certain result rather than an honest one, several tricks can be used. As discussed in Big Pharma’s Gaming of Medical Studies: Twisted Statistics and How to Spot Them – Study Goals and Designs, one of the most common tricks is to move the goal posts. That’s precisely what was done here.

The study did not investigate whether people lived longer or better. They didn’t even investigate whether people have fewer heart attacks—in spite of the fact that prevention of cardiac thrombosis is precisely what the pill of supposed to prevent. No, all they did was investigate whether markers indicative of heart health were changed. That means the study is virtually useless.

Yes, they showed that, in the small sample number of people involved, the Polypill was effective in changing those markers. However, they demonstrated precisely nothing in terms of overall health!

It makes no difference if cholesterol is lowered. It makes no difference if blood pressure is lowered. What matters is the overall effect on health—and the authors do not provide the answer to that, in spite of their bravado in concluding:

 Long term reductions of this magnitude would have a substantial effect in preventing heart attacks and strokes.

They do not know that. Nonetheless, in statements to the press, they make even wilder claims. The BBC reports David Wald as saying:

The health implications of our results are large.

If people took the polypill from age 50, an estimated 28% would benefit by avoiding or delaying a heart attack or stroke during their lifetime.

There is absolutely no mention of the well-known adverse effects of the drugs included in the Polypill. There isn’t even any consideration for those effects in their study. That is, at best, disconcerting. No legitimate researcher could possibly choose to ignore them.

Adverse Effects of the Polypill

The Polypill is a tablet containing amlodipine, losartan, hydrochlorothiazide, and simvastatin. According to Medscape, here’s what the drugs do, along with some of the adverse effects:

• Amlodipine (brand name Norvasc), Calcium Channel Blocker: palpitations (heart running too fast), dizziness, somnolence, headache, fatigue, nausea, edema
• Losartan (brand name Cozaar), Angiotensin receptor blocker (ARB): dizziness, nausea, angioedema, edema, hypotension, weakness/lack of energy, headache, hyperkalemia (inadequate potassium), back pain, worsening liver failure
• Hydrochlorothiazide (brand names Microzide, HydroDiuril), Diuretic (to counter the edema of almlodipine and losartan?):   hypokalemia (inadequate potassium), hypotension (blood pressure too low), Stevens-Johnson syndrome (skin peeling off body), toxic epidermal necrolysis (skin dying), liver damage, pancreatitis, confusion, acidosis, dizziness, fatigue, headache, hypercalcemia (too much calcium), hyperglycemia, lyperlipidemia (excess fat in blood), hypercholesterolemia (high cholesterol), muscle weakness/cramps, nausea, vertigo
• Simvastatin (brand name Zocor), Statin (cholesterol lowering): CPK elevation, rhabdomyolysis (muscle pain/damage – potentially fatal, CPK elevation indicative of this), myopathy (nerve damage), myalgia (neural pain), erectile dysfunction, interstitial lung disease, memory impairment

These drugs, individually, carry significant risks. Combined? Who knows? What we do know is that, as drugs are added to any regime, the adverse effects tend to multiply.

Yet, these so-called scientists have completely ignored these risks, both individually and in combination.

Polypill Target User

With all these risks, one would think that the Polypill is meant for use only in people who are sick, so that the risk might be worthwhile. But that’s not the case. Wald and Wald have much grander ideas. They want everyone who has reached the age of 50 to take them. They have decided that being 50 years old is a diagnosis. Perhaps they should give it a name: Seniorquamel (butchered Latin for Over Age 50).

Wald and Wald think big. They believe that everyone should be taking the Polypill. Nicholas Wald has stated:

We now need public, professional and regulatory support to make the Polypill available without delay; the net benefits are too large to ignore.

In the study’s introduction, the authors state:

The aim of the study was to quantify the effect of this Polypill on blood pressure and serum LDL cholesterol and to compare the observed effects with those previously predicted.

They accomplished that. However, they have used these results, which are so limited as to be useless, to promote the product that, if they can get it approved, will likely make them extremely wealthy. This isn’t science. This is pure abuse of science.