Suspect study; I'm glad the article's author mentions doubt of veracity of the study


#1

Here’s the article: https://www.sfchronicle.com/news/medical/article/Insulin-quality-questions-have-diabetes-experts-12558865.php?utm_campaign=email-premium&utm_source=CMS%20Sharing%20Button&utm_medium=social

Is it any wonder we don’t all blindly believe all studies, or believe all scientists? :slight_smile:


#2

Measuring insulin potency is actually not easy.

As animal tests have been frowned on in recent decades, and manufacturers have moved towards synthetic molecules, the potency is based on calculations during synthesis and not directly on lab tests.

And yes, the newer formulations of insulin are more transport/temperature sensitive than the older insulins.

Historically it was based on the “rabbit unit” and/or the “mouse unit” in animal tests.

http://diabetes.diabetesjournals.org/content/16/3/198


#3

I agree with the original study’s author. There should be a larger study done with a greater number of insulin sources tested. Most importantly, for the sake of patients, the follow-on study should have no connection with any organization or actors with a vested interest in the outcome. Letting Pharma organize and run another study will have very predictable results that I, as a person who needs this medicine to live, will doubt.

I think pulling random vials and pen reservoirs off of pharmacy shelves and then tested by an independent lab should be done on an ongoing basis. This post-production surveillance should be done for all medications. Is the FDA doing this in some form already?


#4

If there is even a trace of validity in this, it simply underscores for the umpteen thousandth time the importance of frequent testing. The only way to know whether the medication you take is controlling blood sugar like it’s supposed to is to test, test, test.


#5

Yes, I thought that their idea that “weak” insulin is going to lead to blindness, etc, was nutty in an age where we can test our bg’s–no need to wait for a lab result.


#6

An increasing number instead use simpler “pens” containing insulin cartridges, pressing them against skin to inject a dose.

Nit picky, I guess, but doesn’t this make it sound like pens are like those Star Trek widgets that inject the medicine without breaking the skin? They’re basically just a more convenient form of syringe.


#7

Well, it’s not totally nutty, if it’s actually true. A lot lot of PWDs (perhaps a majority) aren’t all that aggressive or conscientious about frequent testing. So some things could slip through the cracks. But in principle, it’s as you say, obviously.


#8

I think the audience is mostly diabetic, and they should know that the pens have needles. :slight_smile:


#9

Those T1’s who choose not to test, I’d claim are likely non-complaint, and those are the ones that make up the bulk of the horror stories about diabetic complications.


#10

No argument. And none of this applies unless that “study” is valid to begin with.


#11

What?1?! You mean I am supposed to put a needle on the pen?!?

Well crap, that explains why they haven’t been working for me…
:rofl:


#12

After 52 years of diabetes, I routinely expect that the required insulin dose will undergo some sort of unexpected shift whenever I start a new vial of insulin, so there is nothing especially useful in this study. The apparent inability of the researchers in the study or the article’s author to understand that diabetics testing their blood sugars regularly would obviate the supposed problem here may well be due to a) many diabetes researchers being PhDs who know everything about biochemistry and organic chemistry but nothing about the actual clinical treatment of diabetes, and/or b) the fact that the popular press has little or no understanding of anything to do with diabetes.


#13

There was some hyperbole and questionable info in that article and is does sounds like the study was not very well run.

I’ve run into at least 1 vial of Humalog that I’m convinced was expired or had gotten warm before I started using it. Granted there are a lot of variables that affect our BGs from moment to moment but I had to essentially double the dose I used for the whole vial and then everything went back to “normal” for the next one. I’m diligent about testing so I noticed the lack of potency immediately but I can’t imagine how it would’ve affected a T1 that doesn’t regularly test.

Anyway, I agree there should be mandated tests performed on insulin where it’s manufactured and some sort of random testing done at pharmacies so that shipping and handling processes can be verified as well.


#14

Actually, I subscribe to a medical newsletter for endos that frequently has a “Disaster Averted” section that had a supposedly true story about a patient that did not know that they needed to attach a needle to an insulin pen to get it to inject - and, “surprisingly,” the insulin “wasn’t working.”


#15

I guess they didn’t read the manual. LOL!


#16

RTFM, as they say.


#17

I agree, there should be ongoing testing of all drugs that are out there in pharmacies all over the world. There should be ongoing testing of drugs no matter how long they have been in the market place. As we have seen with blood testing meters, once they pass FDA testing, things can go down hill quickly if the manufacturing is not maintained.
And i’m sorry but insulin is so darn expensive, I want to make sure I am getting every tiny bit I am suppose to get with each bottle.
It is an interesting study and very glad someone did it. I agree it needs to be a much bigger study and not run by the drug companies but by an independent group. We should be getting what we are paying for each and every time.