Tuesday, April 24, 2012

Polypills: Much Ado About Nothing

It is said that the body of medical knowledge is now doubling every five years. Unfortunately, no one said how much of that medical knowledge is useful. Today's blog will serve up a full dose of my deepening cynicism of the value of many medical studies being conducted around the world.

Here's one for fodder with a description excerpted from Medscape.

"April 19, 2012 (Dubai, United Arab Emirates) — A full-dose polypill strategy, combining aspirin, three antihypertensives, and a statin, not surprisingly produced greater drops in blood pressure and LDL cholesterol than those seen in the original half-dose combination pill, but with no significant differences in adverse effects, results of the TIPS2 trial show."

So here's the apparent takeaways from this study. First, that the included medications work in combination. That makes sense as they are often taken together. Second, drugs taken at their usual doasges work better than at half their dosages. Third, that once restored to their normal dosages, the combined drugs had no greater side effects than at half their dosages. Wasn't this known already from prior testing and popular usage of these drugs? Besides, this makes sense as they were used within their tested and FDA approved therapeutic ranges and therefore one would expect minimal side-effects for these commonly used drugs. This study followed a study that wanted to test the effectiveness of a combination pill at half the usual doses which worked but not as well as at regular dosages. 

Are you following the circular logic? They started with half dosages of popular drugs combined in one pill and got lesser results, so they doubled the dosages and got better results. So what?

But here's the real kicker from the article:

"Several key questions remain to be answered. Chief among them is whether a single-pill strategy not only will prove effective but will also actually increase compliance."

You see the problem is that no one wants to develop polypills because they can't be easily patented and they are apparently expensive to produce. Also, given the problem with medication compliance (taking pills as prescribed), it isn't even clear that one pill will get higher adherence than multiple pills do.

In the final analysis, a study shows that at half dosages of a combination of widely used medications you get lesser results. At regular prescribing dosages, you get better clinical results but no greater side effects than at half doses. Yet, no one wants to manufacture such pills because they first need regulatory approval and no one wants to sponsor the expensive studies needed to get such approval because they can't make money off the products because they can't easily patent them.  Most importantly, even if it was approved and produced, there is nothing to show that such polypills can be affordably sold and that they will even improve usage of such drugs.

Given all these facts, it sure seems like much ado about nothing.

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