I was beyond stunned to read an abstract from the Journal of Diabetes Science & Technology that tested the insulin content of vials purchased at random from US pharmacies:
“The insulin content in vials/cartridges should be 95 U/ml upon release. No independent confirmation of insulin concentration is available when purchased in the pharmacy (end of the cold supply chain). We quantitatively measured intact insulin in randomly acquired multidose human insulin vials by standard analytical methods. Eighteen 10 ml vials from two manufacturers (M1 and M2) were randomly acquired. The intact insulin concentration ranged from 13.9 to 94.2 U/ml, mean 40.2 U/ml. No vial met the minimum standard of 95 U/ml.”
So when you pick up your insulin from a pharmacy, you might be getting something that is 10 times more or less effective than what you used last time. WHOA, that could easily kill somebody-you could inject 10 units and it could be the equivalent of 1.39 units, or imagine you had set your doses on the low concentration and so instead of 10 units you were getting a super-potent dose of about 60 units.
The article points the finger at the “cold supply chain”, that is they are asserting that the degradation in insulin potency is happening after leaving the manufacturer and before reaching the consumer. That is as it is transported to wholesalers then pharmacy and stored along the way it is losing potency. This isn’t the same as somebody actually watering down the product in the vials BUT the impact is the same. Given that the study only tested the insulin at the end point of the chain (i.e. vials purchased at pharmacies) we actually can’t know whether the issue is arising in the supply chain or manufacturing or a combination of both.
Whatever the cause, this is simply unacceptable. Where is the FDA? All the expenditure on testing and approvals, the regulatory checks that exist etc are useless if there are gaps in the chain that completely undermine the integrity of a product that is necessary to sustain life. I want to see testing undertaken at each step of the supply chain in every country-including Australia! I have experienced unexplainable variations in my insulin sensitivity and this has been worse in recent years, I’ve had a couple of batches of insulin that I believe have been “dodgy”. Things went back to normal when I got a new batch of insulin.
The reactions to this study have been interesting. Firstly I would like to see some response from the FDA and the insulin manufacturers-but I haven’t seen any. I did tweet Sanofi, Novo and Eli-Lilly to ask if they had a comment-no response. This is serious and requires a response, at least some more testing of insulin at point of supply. If the problem is in the supply chain then it seems to me all manufacturers are likely to face the same problem and it is not acceptable for anyone, the pharmaceutical manufacturer, the distributors, the pharmacy or the government to wash their hands of the problem.
I have been a bit surprised by most of the responses I have seen to this issue. I am outraged that something I rely on to keep me alive can have such varied potency-such that it could kill you from being too strong or too weak. The conclusion of the abstract makes it sound like it’s just an economic problem, “Patients are paying high prices for insulin and should expect to receive insulin vials with adequate insulin content in return.” Whilst this is certainly a significant concern, as somebody** said, we’re paying champagne prices and getting Cool-Aid, the problem is the likelihood of a fatality at worst and serious health consequences.
The other response from many people with diabetes is a “see we told you so”-is it any wonder that our sugars are variable. This is true too, HCPs are quick to blame the patient for bsls outside the target range but never consider that insulin potency could be a factor. So that sick person who comes in with DKA-perhaps they were dealing with an illness AND a vial of insulin that was only 13.9% of what it should have been, or the unconscious hypoglycaemia-perhaps they just got their first full strength batch. I totally get this response and have been yammering on the let’s be realistic about “control” for a long time, I’m just a bit sad that something as outrageous as selling us a dud product that we rely on to sustain life isn’t met with more outrage. I feel this is a reflection of how far the medical system has beaten us down, it’s a bit like we’re being beaten up by all and sundry but we’re keen to say to one of the lesser assailants “it’s not my fault”.
I’m keen to hear your responses to this. Do you think you’ve had dodgy insulin? What do you think should be done? Do you know how the insulin production and distribution process is quality controlled in your country? Let us know if you do!
*J Diabetes Sci Technol. 2017 Dec 1:1932296817747292 [e-pub ahead of print]
**I can’t remember who but happy to acknowledge and link if anyone can point me to the right tweet.Tweet