Pulse Beat

Ills of Statins and Statistical Jugglery

I have been writing for decades that statins cannot, and should not, be used for primary prevention of heart attacks and stroke or, for that matter, any illness, although drug companies brings out newer indications for statins by the day, like a magician bringing out pigeons from his hat. 

A new study, published recently, brings out the truth. I cannot explain it better than the abstract of the study:
“We have provided a critical assessment of research on the reduction of cholesterol levels by statin treatment to reduce cardiovascular disease. Our opinion is that although statins are effective at reducing cholesterol levels, they have failed to substantially improve cardiovascular outcomes. We have described the deceptive approach statin advocates have deployed to create the appearance that cholesterol reduction results in an impressive reduction in cardiovascular disease outcomes through their use of a statistical tool called relative risk reduction (RRR), a method which amplifies the trivial beneficial effects of statins. We have also described how the directors of the clinical trials have succeeded in minimizing the significance of the numerous adverse effects of statin treatment.” 
Look at how statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease. This needs to be explained to a lay reader. 
In any randomised study of drugs to prevent deadly complications, the researchers statistically estimate the number of people in that cohort (group) would have died because of the disease in question if they are not treated or the disease prevented. God only knows how they arrive at that figure! I have a feeling that they do so after getting the final audit on the real deaths in the study group in the next five years or so.
Supposing the estimated figure is 10 deaths and only five have really died during the period of the study. They claim that they have reduced the probable deaths by 50%! A very impressive figure and they go to the market with that grand design! This is called relative risk reduction. But the truth is that one should look for absolute risk reduction. Let us presume that the cohort was 10,000 people studied and five died, in place of the 10 that should have died, the absolute risk reduction (ARR) would be five out of 10,000 and it will be a meagre 0.05%. So ARR would only be 0.05%, a finding not worth tom-tomming. 
In addition, let us say, the drug was statin. The side-effect in 10,000 in five years would be mind boggling. At least 100 of them will become diabetic annually. By the end of five years, we have converted 500 innocent healthy people as diabetics for life! Other complications, like muscle damage, liver damage, kidney failure, etc, would be enormous. See the catch? Use RRR in place of the true ARR. 

Harmful Investigation 

American College of Physicians (ACP) says on its website this year that apparently healthy people without symptoms should not be investigated to rule out heart disease. The effort is useless and might unnecessarily create cardiac neurosis which is worse than a heart attack. This warning has been published in the College’s journal recently. ACP’s guidelines, published in the Annals of Internal Medicine, says that adults with a 10-year risk for coronary heart disease events under 10% should not undergo screening with resting or stress electrocardiography, stress echocardiography, or stress myocardial perfusion imaging. There is no evidence that these tests improve patient outcomes; but they can lead to increased costs and possible harm, such as radiation exposure and unnecessary follow-up tests. 
Instead, clinicians should focus on strategies to modify risk factors—such as smoking, diabetes, hypertension and hyperlipidemia— and encourage physical activity. 
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