With a capital T, that rhymes with P

Here’s a crazy idea: Let’s make a perfect heart health pill – a single pill that contains a statin drug to lower cholesterol, three different drugs (including an ACE inhibitor) to control blood pressure, a low dose of aspirin, and then throw in some folic acid to reduce homocysteine levels.

But wait – let’s get really crazy and say that this pill will not be just for people with heart problems, it will be for everyone over the age of 55. That’s right: everyone. You may not have high blood pressure and you may not have high LDL cholesterol, but as of your 55th birthday your doctor will probably recommend it anyway, just to be on the safe side.

Call it crazy, but what I’ve just described is being touted as a preventive treatment that, in the researchers’ own words, might have “a greater impact on the prevention of disease in the Western world than any other single intervention.”

When someone speaks a line like that with a straight face, you almost expect to hear a dozen trumpets g dat da-da DAAAA!

Collectors, take note

This newly proposed wonder drug for the heart is not only being seriously considered, but it’s also the subject of several articles and an editorial in the prestigious British Medical Journal (BMJ). In fact, in his introduction to the latest issue, BMJ editor Richard Smith suggests to readers that they hang on to their copies and consider them collectors items, stating that it’s been more than half a century since BMJ published something this important.

Cue those trumpets again.

Two professors in the Department of Preventive Medicine at the University of London – Dr. Nicholas Wald and Dr. Malcolm Law – are the masterminds behind this new treatment, which they call the Polypill. At this point the Polypill is only an idea, but Wald and Law are so taken with their imagined pill that they’ve filed both a trademark and a patent application for the proposed formulation.

“Proof” purchased

To determine the ingredients of their Polypill, Wald and Law first set a goal to address four cardiovascular risk factors: LDL cholesterol, high blood pressure, homocysteine levels, and platelet function. Then they went looking for studies that would support the use of ingredients that would: a) meet their risk factor reduction goals, b) work effectively, and c) have few side effects.

By incorporating the results of several “meta-analysis” research projects that examined a range of different studies, they say they’ve included the data of more than 750 trials, involving more than 400,000 subjects. And while that might sound impressive to the casual reader, we know the realities behind this type of research.

For instance, many of those trials would obviously involve prescription drugs. And because such studies are very expensive, they’re almost always funded by drug manufacturers. Research has also shown that sources of funding often influence the outcomes of studies. And when a study develops unwanted conclusions, the funding source often exercises the option to not report the study at all.

In other words – much of Wald and Law’s data supporting Polypill’s use of statins and high blood pressure medications is almost certainly working from a stacked deck. Nevertheless, W. and L. conclude that the Polypill could prevent 80 percent of heart attacks and stroke if taken by EVERYONE aged 55 and older, as well as everyone who already has cardiovascular disease.

When “acceptable” turns dangerous

And what about side effects? Wald and Law predict that the Polypill would be “acceptably safe.” Would that be kind of like the way the Titanic was “acceptably safe” from icebergs?

When you hear pharmaceutical researchers use the phrase “acceptably safe,” you know it’s time to run for cover.

In one of the other Polypill articles that appears in the current BMJ issue, Dr. Anthony Rodgers – the co-director of the Clinical Trials Research Unit at the University of Auckland, New Zealand – says that the projected number of patients that might discontinue use of the pill due to side effects would be only one or two per every 100. That doesn’t sound like much, unless you add up all the people over the age of 55 and all the people with cardiovascular disease. Then you’re talking about many thousands.

In addition, Dr. Rodgers states that the fatal side effects of the Polypill would be less than one in 10,000 users. Again, that may not sound like a huge death toll, but under the Wald/Law plan, tens of millions would pop the Polypill, resulting in hundreds or thousands of deaths each year. This bottom-line mentality tallies up data and concludes that saving the lives of 80 percent of all cardio patients at the expense of others is “acceptably safe.”

But what’s “acceptable” in the research lab is often entirely unacceptable out here in the real world. Especially in this case, simply because there are so many safer ways to address cardiovascular disease.

Feel-good spin

The projected numbers of Wald and Law are wildly optimistic. Not to mention completely wrongheaded. But don’t expect the mainstream to tread carefully as they run to embrace the Polypill.

In an Australian Broadcasting Corporation report, University of Queensland Professor Chris Del Mar (described as an expert in the field of “evidence-based” medicine) gushed about what he called the “whole population approach” of the Polypill, comparing it favorably to the fluoridation of public water supplies. In his estimation, the Polypill would be so safe that it should be available over-the-counter.

That’s great. While they’re at it, why not make it available in chewable flavors and sell it at grocery checkout counters? Or better yet, go ahead and add it to our water supply. Then they won’t have to worry about the non-compliant 55+ crowd ruining their press releases.

Professor Del Mar, Dr. Rodgers, Richard Smith and many others already seem to be signed, sealed, and delivered on the one-size-fits-all, magic heart pill. And I’m sure that everyone in this optimistic crowd will do all they can to help sell the Polypill to the general public as Wald and Law take their plan from proposal through development, clinical trials, and manufacturing.

So I’ll keep you posted, because we’re sure to hear more about this one. And if you have one of those “collectible” current issues of the BMJ, I think it is a good idea to save it. It may turn out to be one of the most laughably misguided predictions of the future in the past 50 years. Or one of the scariest.

No trumpets, please.

To Your Good Health,

Jenny Thompson
Health Sciences Institute

“A Strategy to Reduce Cardiovascular Disease by More than 80%” Dr. Nicholas Wald and Dr. Malcolm Law, British Medical Journal; 326: 1419, 6/28/03, bmj.com
“A Cure for Cardiovascular Disease?” Anthony Rodgers, British Medical Journal; 326: 1407, 6/28/03, bmj.com
“Comparison of Methods to Identify Individuals at Increased Risk of Coronary Disease from the General Population” British Medical Journal; 326: 1436, 6/28/03, bmj.com
“The Most Important BMJ for 50 Years?” British Medical Journal; 326, 6/28/03, bmj.com
“Heart ‘Polypill’ Stirs Controversy” Associated Press, 6/26/03, msnbc.com
“Single Pill may Cut Heart Disease Risk by 80%” Australian Broadcasting Corporation Science Online and Reuters, 6/27/03, abc.net.au
“The World Today – Questions Raised over Polypill” Tanya Nolan, Australian Broadcasting Corporation, 6/27/03, abc.net.au