Sunday, May 24, 2009

Got a patent for drug combinations on cardiovascular disease? How about "proving" everyone needs the drug...

[Click on the following for Link to External Article]

Click here for the Medscape Article

The actual study is here:

Click Here

The Premise

Call me a skeptic, call me rude, call me anything you want..But having seen and known too much about conflicts of interest and bias in clinical trials and studies, I become suspicious, especially so when I see small studies and more importantly "meta analyses" make broad stroke recommendations.

Thus when I saw a study that said "Feed all old people anti-hypertensives", I became wary. Alright, the title of the article was a little less crude, I admit. But, nevertheless, it did not please me. Let's examine some quick facts:

Some notes on the study

1. The study examined data from 147 clinical trials conducted over 40 years.

2. The study concluded that all 5 major classes of anti-hypertensives seemed to reduce the risk of cardiovascular events regardless of the patients' history with respect to either prior cardiovascular events/risk or hypertension.

3. How much of a reduction in pressure where they looking for? A 10mm mercury reduction in systolic and 5mm in diastolic pressures.

Results, Conclusions and Recommendations

The study results do look good, just like they do in meta-analyses. After all, you are not directly studying something, just looking for what you would like to see.

People with hypertension are definitely on their path to cardiovascular events. The real difference comes from a combination of hypertension and other factors.

What is the real gripe?

The studies should have focused on reducing hypertension, and consequentially, cardiovascular events in patient populations pre-disposed to hypertensive and cardiac disease. If the 22% reduction in coronary artery disease and 44% reduction in stroke was comparable in both groups, how can we actually assume that patients who we consider not pre-disposed to CV/hypertensive were indeed not actually pre-disposed to the disease?

Well, there can only be one of three answers:

1. That, in these studies, at a broad level, folks who were not considered "at risk" were indeed at risk, and 147 studies were designed poorly. Okay, that is an extreme position to take, but at least some of the studies should be wrong, right?

If not, shouldn't you see a comparable decrease in CV events in patients/controls considered not "at risk"? Well, let's consider the other possibilities.

2. It is quite possible that the controls who were not considered "at risk" would have not really taken good care of their health. They let their life styles slip and as a result, ended up with cardiovascular disease.

3. Since at least some of these studies were treating patients for other factors, such as cholesterol, it is possible that they had a role to play in disease mitigation and the 22% and the 41% might have been influenced by the study population being treated for other conditions - see the problem with "large" and "comprehensive" meta analysis?

The Conclusion and a Side Note

Anyway, at the end of it all, when I came down to the article's end, I found out that the scientists involved in the study, who recommended (albeit with warnings on the fringe about drug combinations) that every "older adult" should be asked to take anti-hypertensive medicine actually own patents on drug combinations...

You can conclude the rest for yourself, but I am no Doctor, and still, I am going to try the "lifestyle change". I really think the idea of popping anti-hypertensives after I reach my "older adult" stage sucks. If that is what I am looking for, I might as well harm my already poor lifestyle a tad bit more...

Other problems?

1. What about people prone to low blood pressure? What if some company thinks it is a great idea to make blood pressure medicines to be a "dietary supplement" and someone prone to lower blood pressure accidentally takes it?

2. Hmm, have you thought about side effects of blood pressure meds before telling the world to take 'em?

A side note: Was aspirin also gold-standardized in a similar manner for all "older adults"?

You know, with the new wave of recommendations on hypertension coming from the old world on the basis of some extremely strong metanalysis, I got to wondering if Aspirin was also pushed on us in a similar manner. Remember when Bayer wanted to call Aspirin a "Dietary Supplement"?

Well, it does not appear to be as flimsy as the anti-hypertensives:

The AHA seems to have done a fair job, with 22,071 male physicians testing themselves with aspirin as an alternate therapy, resulting in a 44% reduction in MI. Of course, given they are physicians and knew about hypertension, hyperlipidimia (fancy for High Cholesterol) and smoking, maybe, just maybe some of them made "lifestyle changes".

Somewhat comforting, eh?

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