Insulin Concentration Concerns: A message from William T. Cefalu, MD

We have severe issues in regards to the article, “Insulin Concentration in Vials Randomly Purchased in Pharmacies in the United States: Considerable Loss in the Cold Supply Chain,”^[1] printed within the Journal of Diabetes Science and Technology on December 21, 2017.

The article describes measuring insulin focus in vials of human insulin (common and NPH) from totally different pharmacies at totally different occasions of the 12 months, from two totally different producers. The authors report a imply efficiency of roughly 40 U/ml as a substitute of the FDA-mandated >95 U/ml, with the common human insulin alone averaging lower than 25 U/ml efficiency and the NPH at roughly 55 U/ml.

The variety of samples studied is extraordinarily small (18 vials whole) in relation to the variety of vials manufactured and allotted, and the methodology for pattern dealing with and preparation is minimally described. More necessary, there are severe issues about whether or not the outcomes match real-world expertise and whether or not applicable testing strategies had been used. We have consulted with each scientific and biochemistry consultants on this space. Several main scientific consultants have acknowledged that the examine’s outcomes are inconsistent with their expertise of utilizing pharmacy-obtained insulin in managed scientific analysis research the place sufferers are capable of obtain correct blood glucose management, thus the insulin efficiency is clearly in-line with the labeled 100 U/ml. From a biochemistry perspective, there are issues in regards to the testing methodology used—why didn’t they use the widespread and available insulin assays usually used to measure insulin efficiency?

We have additionally been in communication with insulin producers. We have reviewed and confirmed the standard management procedures which can be strictly adhered to and documented by every producer all through the provision chain, from manufacturing to supply, to fulfill FDA requirements to make sure the protection, efficiency and efficacy of insulin.

Based on these findings, now we have no purpose to consider that the outcomes of Carter et al.’s examine replicate the precise efficiency of human insulin extensively obtainable at retail pharmacies within the United States. We strongly urge sufferers to speak with their medical doctors and pharmacists about any issues they’ve with their insulin or diabetes remedy plan.

—William T. Cefalu, MD, Chief Scientific, Medical and Mission Officer, American Diabetes Association

^[1] Carter, AW and Heinemann, L. Insulin Concentration in Vials Randomly Purchased in Pharmacies within the United States: Considerable Loss within the Cold Supply Chain. Journal of Diabetes Science and Technology. https://doi.org/10.1177/1932296817747292