When they originally flagged the NDMA issue in Zantac, they published their results. One of the tablets had 32,000 ppm of NDMA. That’s an absurdly high level that should have made them question the result.
Turns out they used a different testing procedure for a different set of drugs. The procedure required heating the sample to 80c for like an hour. The FDA came back and said “yeah, that’s not the right test”. Many drugs will decompose with heat and produce a bunch of impurities. Impurities that aren’t produced in the human body.
Testing for impurities is actually really hard as your testing procedure can have a big impact on the measurements.
Based on the latest FDA guidance, it sounds like Zantac does have higher than allowed NDMA levels, but nothing like what this lab suggests.
So I’d say they are offering a useful service, but they aren’t sophisticated enough to make a judgement call on.
That said, you are correct. Stacked up against all the risk you might face in life this isn’t that concerning.
Because that's the sort of thing that can blow out a lawsuit or result in bad press.
The FDA is doing a great job keeping the public informed.
Check out the 10/2 update with regards to temperature. Here is the relevant part:
FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure. FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA.
To Valisure’s credit they are posting their data.
However, they are using GC/MS, which typically had pre-column temperatures of >150C (since all analyses need to be in the gas phase). Plenty of drugs decompose at those temperatures. That’s why the FDA doesn’t recommend it.
> This means you heat the drug up to 130 degrees celsius for 15 minutes [130°C=266°F]
That's more temperature than the 80°C in the GP comment. It's common that drugs decompose with temperature.
> And tested again and found 300,000 nanograms of NDMA in one tablet of Zantac
> SGF with 50mM Sodium Nitrite | 3,045 [ng/ml] | 304,500 [ng/tablet]
[SGF = simulated gastric fluid, 37°C=98°F, I'd like to see the pH, let's assume 2 or something]
The concentration of Sodium Nitrite is weird because it is like x500 bigger than the maximal allowed level in drinking water, and it is also like a hundred times the concentration you'd get from sausages.
As I mentioned earlier, testing pharmaceuticals is not easy. Usually you need to develop a specific method for each drug and then validate it. It’s very easy to actually introduce an impurity (or the appearance of an impurity) with the wrong process.
Ranitidine (Zantac) is even more challenging when it comes to NMDA. Most drugs have that impurity from the manufacturing process. Solvents and chemicals react to produce traces of it. Ranitidine has the building blocks of NMDA in the molecule itself. So decomposition of ranitidine will produce NMDA. You could start with 100% pure ranitidine and if you test it wrong, you’ll produce NMDA and be convinced it was in the original material when it wasn’t.
While your interpretation seems to be that using the different test brings these wild results into question, this discussion seems to conclude that, yes, it's a different test, but no, the results are no less concerning.
Take a listen for yourself!
Bear in mind this company makes money by testing regular medications and assuring their drug content and safety - they have a financial motivation to find problems in available medications. This is not to say that production standards may not be ideal for medications, but it does mean one should be skeptical of their claim.
Alarmism is popular in health. Look at the removal of vaping products, despite studies demonstrating their general safety. As if the risks of smoking aren't already known and fairly major.
Edit: try also https://outline.com/ykCXfg
Update: Actually, I just changed my user-agent from one that advertises my browser as emacs-w3m to one that advertises itself as a common Mozilla/Chrome/Safari browser and I no longer get redirected and can read the original article just fine.
I tried and this just worked for me:
ftp -o wp.html http://www.washingtonpost.com/science ...
So many ways to skin a cat, so to speak!
Second time I have heard about this ... which is confusing because I use lynx on a regular basis on OpenBSD.
tl;dr: 188.8.131.52 doesn't pass along any client IP information for privacy reasons and archive.is won't return a good DNS response without it
Passing just the subnet is not revealing your IP. IP reveal would have much bigger privacy implications.
Cloudflare's conflict of interest is what Archive.is is really protesting. More here: https://webapps.stackexchange.com/questions/135222/why-does-...
Honestly, we should have an independent 3rd party with zero financial investment in either approving or rejecting a quality check of a batch sample. Something Federal, so manufacturers cant "shop states", that administers and regulates drugs and their distribution. Not sure what I would call it. I tend to go with cartoonish things, so Merlin after the bumbling wizard sounds fun, but the bureaucrat in me thinks the acronym "F.D.A." would suffice.
It's somewhat similar to the role of the NHTSA(?). They set the general rules and approve each vehicle model, but they don't go to the factory to test each single car.
Does you find it somehow misleading?
Apparently in 2019 it's not advertising unless it's misleading...
Sometimes, as a journalist, you set out to report interesting and important facts; an the facts are such that just a bare reporting of them leaves readers with a positive impression of a company, no matter how you editorialize. A company is just ...doing something good, and good in a novel way. And that’s news! Just as much as if a company were doing something bad in a novel way.
Presuming the piece was written genuinely, instead of being submarine PR, the journalist’s goal isn’t usually to get people to interact with the company (just like their goal with reporting of negative novel behaviour isn’t usually to cause a boycott—that’d be the job of an editorial.) Instead, the goal of such pieces is to make readers say “well—this changes things.” To make them think about how the world is going to be different for the presence of this new activity in it. Basically, to accomplish what speculative fiction sets out to accomplish, but with fewer tools in the toolbox.
I can understand calling that “advertising” in some literal technical sense. But if you are intending to morally color the article by calling it advertising, while receding back to the claim that it is “literally, technically” advertising, then readers should be wary: that’s a classic motte-and-bailey argument† (despite the motte and the bailey both being “it’s advertising”—‘advertising’ is used in a different sense in each claim.)