Wow, the shock waves continue!
Insulin quality questions have diabetes experts scrambling was reported by Linda Johnson on APNews.com, 7 February 2017. Really?!?!?
Preliminary research suggesting that some diabetes patients may be injecting medicine that has partially disintegrated is causing concern even as serious questions are raised about the research itself.
The study author, a pharmacist, bought vials of insulin at a number of pharmacies and found that on average the vials had less than half of what was listed on the label and none met a minimum standard.
The study tested just 18 vials of insulin — far too few to be definitive — and questions have been raised about the methods used to test the insulin. Insulin makers, patient advocate groups and diabetes experts say if the findings were accurate, diabetes patients would be getting sick.
But given potentially serious implications for millions of diabetics, many of these groups are now trying to reassure patients in the wake of the research. All say that patients should continue to taking their insulin as prescribed.
The original study, published Dec. 21 in the Journal of Diabetes Science and Technology, tested insulin solutions in vials bought at multiple pharmacies, supplied by different wholesalers, in Kansas and Missouri. They included insulin made by Novo Nordisk and Eli Lilly and Co.
The concentration, or number of insulin units in the liquid solution, was labeled as 100 units per milliliter. But they averaged less than half of that, and none met the 95-unit minimum standard, said lead researcher Alan Carter, a pharmacist and adjunct instructor at the University of Missouri-Kansas City School of Pharmacy.
“It blew us all away,” said Carter, who did the research while working at not-for-profit contract research firm MRIGlobal in Kansas City.
The U.S. Food and Drug Administration requires that insulin batches be tested before leaving the factory. The insulin then must be kept cool, in a narrow temperature range, as it is shipped to a warehouse and then to pharmacies. The FDA conducts spot checks during the process.
Carter thinks the insulin may have gotten too warm somewhere between the factory and the pharmacy, causing some of the molecules to break apart.
Insulin makers stand by their products, saying they meet strict government quality regulations. Diabetes experts say there’s little chance that insulin being sold nationwide is so degraded.
“If that were true, then you would have the emergency rooms full with uncontrolled diabetic patients,” said Bernd Meibohm, a pharmaceutical sciences professor and research director at the University of Tennessee College of Pharmacy.
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