A preliminary research led by pharmacist and researcher, Alan Carter, in the US, suggests that some diabetes patients may be injecting partially disintegrated insulin as treatment. The research has caused widespread concern despite questions about its credibility.
The study randomly sampled 18 vials – far too few to be significant – of regular human insulin and NPH insulin from five different pharmacies, and quantitatively measure the insulin concentration.
Carter claims that on average, the vials had less than half of what was labelled and none met the expected minimum of 95-unit – as required by the United States Pharmacopeia (USP) and the US Food and Drug Administration (FDA). A mean concentration of 40.2 unit per millilitre was detected, instead.
“It blew us all away,” says Carter, who also works for a not-for-profit contract research firm, MRIGlobal. He however, admitted that his results may be flawed due to his limited budget, and hopes someone would carry a bigger follow-up study.
A cause for concern or just faff?The announcement, no doubt, has caused a ripple of criticism and outrage among patients and physicians alike. Many denounced the small number of vials tested, and some even argued that there is a mismatch between what the study results indicate and the real-world experience.
Insulin makers, patient advocate groups, and diabetes experts say if the research was accurate, diabetes patients would be sicker than expected already.
“The (insulin) concentration and the amount you give, if just a little bit off, can have huge consequences,” emphasises Aaron Kowalski of JDRF, which funds diabetes research in the US.
Insulin is an indispensable treatment to many diabetic patients. Therefore, the quality control of the production, storage, and dissemination of these products are tightly regulated and monitored. One of the major challenges is to ensure the viability of insulin by maintaining the cold chain, or temperature-controlled supply chain – as insulin is very sensitive to temperature fluctuations.
Study highlights supply chain problemsThe US FDA dictates that all insulin products must be kept within a narrow temperature range at all times. This includes the long shipping journey from the manufacturing site to the intermediate warehouses, and ultimately arriving at pharmacies which will dispense them. Throughout the whole cold chain transport, insulin must be kept refrigerated. Products that are kept at room temperature may maintain its potency for only up to 28 days (caution that variations in stability between insulin types do happen).
It is a known fact that insulin will disintegrate when stored outside the temperature range amongst healthcare professionals. However, it is the independent confirmation of the insulin concentration at the end of the supply chain, i.e. at the retail pharmacies, that is lacking.
Now, most of the quality assurance comes from the manufacturers, which, unfortunately, do not have much control over the storage condition of the products once they are shipped out of the manufacturing plants.
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Larger-scale study to put the matter to restThe news has left many diabetic patients scrambling for alternatives to injecting insulin – despite reassurance from many clinical experts that insulin injections should still be safe and effective.
For example, for a quick release of insulin, a powder form is now available to diabetic patients in a tiny, thumb-size device where the medicine is delivered via oral inhalation. The rapid-acting insulin is designed for use at the beginning of a meal, and should be used in combination with a basal, long-acting insulin for patients with type-1 diabetes. However, it comes with a risk of acute bronchospasm in patients with chronic lung disease.
Another exciting addition to the arsenal against diabetes is the artificial pancreas. It is a closed-loop insulin delivery system, which detects blood sugar level and automatically adjusts the amount insulin needed before delivering it via an insulin pump. In 2015, a four-year-old boy with type-1 diabetes became the first patient to be fitted with an artificial pancreas.
Other scientists have tried reversing type-1 diabetes and have done so successfully in mice models. Stem cells were pre-treated to produce a higher amount of PD-L1 protein. Once infused into mice with type-1 diabetes, almost all of the animals were cured of the disease in the short term, and one in three had normoglycaemia for the rest of their lives.
Meanwhile, given the potential implications of the Carter’s findings, many clinical and research groups in the US are planning to undertake a major study of a larger scale to conclude the matter.
“We want to make sure the study, when completed, will be well accepted,” states chief scientific officer of the American Diabetes Association, Dr William Cefalu. MIMS
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