This short medscape article reveals some alarmingly inconsistent potency of insulins randomly purchased and tested at USA pharmacies…
Definitely worth reading and considering. The study was done on R and NPH insulins, so it’s an open question if the same inconsistencies are plaguing analogs by the time they reach the end user—- hopefully that’s a question that additional investigation will answer soon.
I certainly hope this doesn’t end up being used as another excuse to jack up the price if they’re ultimately required to improve quality control in manufacturing or in the supply chain and distribution.
This is straight-up horrifying. And enraging. I wonder if there’s a way to crowd-source the testing that would establish potency for other types of insulin – Novo and Lilly say in their statements that the protocol they use to meet FDA guidelines is a publicly known process. So I’m sure there are others in labs around the country who have access to the necessary equipment to do this testing.
That is shocking and frightening:
Standards established by the US Pharmacopeia and Food and Drug Administration (FDA) require that insulin vials and cartridges contain a minimum of 95% intact insulin (95 U/mL).
In contrast, Drs Carter and Heinemann found that the average amount in 18 10-mL vials of NPH and regular insulin from the two major manufacturers, Novo Nordisk and Lilly, was just 40.2 U/mL, ranging from 13.9 to 94.2 U/mL. None met the 95-U/mL standard at the time of testing. [bold emphasis mine]
Totaly worth a read.
I can see a class action lawsuit on the horizon.
Any class action attorneys here at FUD?
This would begin to explain the “I thought I got it sorted out in diabetesland, and then one day I didn’t” issue.
And yes, it is totally horrifying.