Tuesday, May 22, 2012

Coarse grain data aka Big Data medicine and risk of the z-Pak

The EP cardiologist and long time medical blogger, Dr Wes, hits a home run with this commentary about the recent study that claimed a relationship between cardiac death and the use of azitromycin and some of the bigger issues with what he calls "Big Data Medicine".

The article in question appeared in a recent issue of the big impact medicine journal the, NEJM.
See here.

The authors reported an increased risk of cardiovascular death with a hazard ratio of 2.49 (1.38--4.5) and an overall mortality risk of 2.02 (1.24 --3.30). The ratios are a bit too high for me to make my usual comments ( see here ) about relative risks less than 2.

Azitromycin has been associated with a prolonged Q-T interval so the door is open to speculate about a pathophysiological mechanism that could explain the results if the association is real and not the artifact of crunching large numbers through the filters of a cascade of assumptions. How long will it be before we will be treated to an alternative statistical story from the epidemiologists at Pfizer which has been marketing Zithromax since 1991. Meanwhile the FDA promises to take the matter under consideration.

1 comment:

Anonymous said...

The people that complain about the Q-T interval changes are 'chicken littles'. I am a retired pharmacist and have used the ZPak on a number of occasions...and I didn't die! You see, if I could have possibly been at any risk of a heart problem, secondary to the Z Pak...my physician would have monitored me and given me warning signs should the unlikely event of heart conductivity be effected. ZPak is a great product. It's spectrum of killing microorganisms is substantially better than eneric Erythromycin(which eats up my stomach!). It has prevented 100,000's of people from ending up in the emergency room or the hospital ward. The off chance of the ZPak having any effect on electric conductivity has long been known and caution has been taken by every good physician. This is just sensationalism by egocentric troublemakers with nothing positive to give to society. They just want to be on TV!. This is unnecessary emotional upheaval by bad people. I have given ZPak to my children and would give it to my parents if they were still alive. If you have a half-decent physician, then you have nothing to worry about. He could check your heart before prescribing the ZPak. I resent this scaring of the public unnecessarily. These are evil people that are crying 'fire'; ZPak is a great product.
Ron Diamond R.Ph.(retired 2005)