There is a lively discussion over at KevinMD about the azithromycin study in the New England Journal of Medicine, which I blogged about here. A certain ethos has emerged in the comments that bears unpacking. There are 3 distinct points that I am feeling unsetlled by:
#1. As a retrospective cohort study it should be ignored.
This is an intellectually indefensible position in my mind -- it is a study that uses a set of methods developed and validated for this type of data. Yes, it's complex; yes, it's messy; no, it's not to be ignored. The discipline of pharmacoepidemiology relies heavily on observational data. To expect anything more is to indulge in misapprehensions that a). it is feasible to run a RCT to detect such rare signals, and 2). that a RCT like that would give us a definitive answer.
#2. They really had to add a lot of zeros to the denominator to make the numerator seem impressive.
This is a baseless accusation, since 1 million prescriptions is not that difficult to generate. Z-pak has been on the market for over a decade, and according to this article, last year 55 million prescriptions for azithro were handed out in the US. So, just a back-of-the-envelope calculation for excess deaths per year at this rate is well over 2,000. And this is just in one year! So, as a safety signal this is not something to be trivialized.
#3. A concern that this information will keep patients from doctors' offices and delay needed treatment.
I find this to be rather a hollow concern (though I am sure that the person putting it forward believes it wholeheartedly). As another commenter pointed out, the overuse and misuse of antibiotics is completely out of control! And yes, cardiac deaths from azithromycin are but a small part of the issue, where the elephant in the room is the evolution of resistance. It is not just these latest data that should keep patients as far away as possible from unnecessary healthcare encounters, seeing as how these encounters are the third leading cause of death in the US. Why aren't we worried that this entire monster is keeping patients away? And quite frankly, why isn't it?
So, all in all, I am very glad that Rob Lamberts chose to blog the study, and the discussion has been worthwhile. The comments have really confirmed for me that it is not only the lay public, but also healthcare professionals, who have a hard time interpreting data. And when a study is somewhat challenging, it is generally easier to let our cognitive biases run amok.
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