In this video, Valisure founder and CEO David Light discusses the company’s findings of probable human carcinogen NDMA in metformin, the widely prescribed diabetes medication.
Metformin um a top uh diabetes drug for uh the the maintenance or control of uh of blood sugar um and it’s also the number four most prescribed drug in the united states you can see in in the simple molecule of metformin the dimethylamine group is now again here however unlike renidine there is no uh nitrite or nitrate uh source on on the drug itself um
So in our also limited studies it appears to be a pretty stable drug and and that uh sources of ndma are likely in in the manufacturing not from the instability of the drug itself um however uh it’s been found with uh significant amounts of ndma and recalls have already happened in canada in switzerland in singapore ndma itself as as a compound has been very
Heavily studied since the 1950s so it’s actually one of the most potent carcinogens on the planet one of the best studied um there was even a international symposium and meeting organized by the world health organization and the united nations in 1978 specifically in nitrosamine carcinogens and to this day it’s even used as a control to induce cancer in rats
So if you’re running a study and you want to make sure that a rat’s going to get cancer you give it mdma and just a few weeks ago we released our study um very uh broadly looking at manufacturing of uh of metformin uh from a variety of different companies in the united states uh that are selling in the united states obviously manufacturers all over the world
And uh it was pretty concerning results so we were able to test 22 different manufacturers from the various distributors that we do business with and about half of the manufacturers actually exactly half in in our study 11 of the 22 had at least one batch that was above the fda limit for the amount of ndma in them quite a number of batches had over 10 times
The allowable amount of ndma and this was certainly the most extensive study that’s been done so far we had 22 companies in 38 batches and 16 of those batches failed the fda has also been concerned about metformin actually did some of their own testing um and uh however uh they they showed uh no uh ndma above acceptable limits in in the uh seven manufacturers
That they analyzed and a little over a dozen batches however important to keep in mind that the fda is is most likely acquiring their medications by asking for a sample from the manufacturer um so obviously has its pick over which samples to send to the fda if they decide to send a sample at all again it’s a very voluntary process uh in the united states
Um whereas uh with falsehood the the advantage of being attached to a pharmacy is we actually take it direct from the real world uh distribution of pharmaceuticals that all pharmacies get their products from uh so certainly a very unbiased look at what is really in the pharmacies in the united states um and there’s also some overlap with the recalls in canada
In terms of the bat of the manufacturers and the batches that we saw problems with and um so we we just filed this of course it made uh some news as well and uh hope that the manufacturers and the fda are going to be paying more attention especially in the areas that there’s particularly high failures to start to clean up this supply of this critical drug uh
Where there really aren’t that many alternatives and also on the metformin side uh we definitely want everybody to be aware that we’ve just now kicked off a project to really get the ideal uh broadest net of chemical analysis of all the various manufacturers of metformin so you know even uh at the val sure level we’re able to buy from a variety of different
Uh distributors uh here at vallasher but what a an average american patient actually gets could be from all sorts of suppliers all over the u.s and so we’ve launched a program where we will do that analysis of actually taking a sample from an individual that can send us a sample of medication of metformin and we’ll do the analysis for free so usually we offer
This service as a forty dollar service and it was actually through exactly this individual uh individual’s ability to send samples which is how we found out about metformin in the first place uh you know the batches as dina was talking about uh that we buy for the pharmacy are usually quite large and if they’re clean and good then we don’t look any further and
What we had in our own pharmacy was clean and good to sell and it was when a patient sent a sample or a you know a client of their own of the medication that they had um that we saw a new manufacturer that we hadn’t tested yet before and was very high in its mdma levels which is what got us to actually analyze all the manufacturers that we could get a hold of
But long story short is that if you take this coupon code met test 20 and anybody that has a sample of metformin that they want to send to us we’ll do the analysis at no cost and this is going to be really a first of its kind scientific chemistry study that should give us a lot of information over the the all the various manufacturers in the united states and
Try and focus the efforts of the fda and and push these manufacturers to do uh what’s right which is recall these contaminated drugs and then clean them up so we can have a clean supply and not have to worry about carcinogens in such a critical medication you
Transcribed from video
Valisure findings with metformin Valisure Video Seminar, 3-15-20 (2 of 4) By Valisure
