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A tiny pharmacy is identifying problems with common drugs (washingtonpost.com)
139 points by pujjad 10 days ago | hide | past | web | favorite | 41 comments





I dug into this a bit and while they are doing some testing, I’m not sure they really know what they are doing.

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.


The same article says the level of NDMA is similar to that in barbecue meat. So much medicine recalled, and panic from major manufacturers (why didn't they test before panicking?), over a result that may not be even accurate in the first place.

It’s probably two reasons: 1) it’s a carcinogen and cancer risks make headlines and 2) it’s a risk that wasn’t there to begin with (unlike bbq meat which was known).

That said, you are correct. Stacked up against all the risk you might face in life this isn’t that concerning.


> why didn't they test before panicking?

Because that's the sort of thing that can blow out a lawsuit or result in bad press.


Do you have a link for the 80°C (176°F)? In that case the description in the article "emulated the stomach" is misleading at least. The 80°C (176°F) is more like sous vide cooking.

It may not have been that high, but I remember being surprised by how much higher than physiological temperature.

The FDA is doing a great job keeping the public informed.

https://www.fda.gov/drugs/drug-safety-and-availability/fda-u...

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.

https://www.valisure.com/wp-content/uploads/Attachment-B-GC-...

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.


Posted a response to OP, but if you want to hear the pharmacy CEO discuss this testing in depth with Dr. Peter Attia, check out their podcast from a few weeks ago

https://podcasts.apple.com/us/podcast/the-peter-attia-drive/... https://peterattiamd.com/davidlight/


Thanks for the link. Some relevant quotes:

> 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.


You're welcome! This stuff is way outside my area of expertise, but I'm obviously curious what the heck is going on. Glad to see this discussion here on HN.

Thanks for posting the podcast link.

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.


Appreciate you breaking that down! Really illuminates how complex and challenging chemistry and biology are.

The testing issue is discussed thoroughly in the podcast interview Dr. Peter Attia did with David Light (Valisure CEO).

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!

https://peterattiamd.com/davidlight/ https://podcasts.apple.com/us/podcast/the-peter-attia-drive/...


This sounds a bit alarmist. So the chief medical officer of the company is also the editor-in-chief of the journal they publish in? And the paper is about the rapid release of tylenol, not about the cancerous effects of ranitidine?

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.



Is there an archive of this article that doesn't require Javascript?

Firefox + NoScript + No Previous Cookies (from anyone) --> no problem reading the original article.

It doesn't work for me in emacs-w3m, which does not understand Javascript. I just get redirected to the the washingtonpost.com front page.

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.


FWIW I just played around with this. OpenBSD used to include lynx, but now doesn't. I found mailing list question on this and the answer was to use ftp!!!

I tried and this just worked for me:

   ftp -o wp.html http://www.washingtonpost.com/science ...
That fails and automatically switches to https and then fetches the article. The formatting isn't ideal but the article text is readable.

So many ways to skin a cat, so to speak!


>OpenBSD used to include lynx, but now doesn't.

Second time I have heard about this ... which is confusing because I use lynx on a regular basis on OpenBSD.


It's in ports/packages now, but it used to be in base.

I get a 404 visiting that link...

You're probably using Cloudflare's DNS resolver.

And, so, why? What's Clouflare doing wrong?

https://news.ycombinator.com/item?id=19828317

tl;dr: 1.1.1.1 doesn't pass along any client IP information for privacy reasons and archive.is won't return a good DNS response without it


>for privacy reasons

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-...


This sounds kinda a like a bug bounty program for pharama. We should have more companies specially the big PBM's doing more of this.

PBMs are rent seeking middlemen. Their desire to seek the lowest drug price is arguably what contributes to things like quality standards at pharmaceutical manufactures slowly loosening and contaminants getting into the supply line.

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.


Nitpicking: The FDA doesn't test every single batch of each product. They review the results of the clinical trials and then they set the rules to approve the batches. When a batch is ready, someone in the drug production factory is responsible to check that all the test and quality meet the regulations and then sign a paper approving the release. S/he must have a degree in pharmacology or chemistry or something similar. If something gets wrong the person that signed the release approval is the first one that get questioned, so they should be very careful.

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.



This was a really good interview with the CEO of this pharmacy where he describes they business model and research process: https://peterattiamd.com/davidlight/

I wonder if the exit strategy of this company is to be a big enough nuisance to Pharma that one of them buys the company in order to absorb and nullify it.

nice ad

It does paint a compelling picture of the problem and a company that provides a solution.

Does you find it somehow misleading?


I found it interesting enough to read all of the way through and am grateful that someone to testing drugs but the writing was plainly from a marketer and even included dumb anecdotes to humanize the founders, fawn over their origin story, etc. I was actually waiting to see "started in a garage".

According to others in this thread, their finding is misleading. They are incentivized to find problems where their aren't any in order to stay in the headlines. The article indeed reads like a PR piece. All in all though, I'm glad they exist.

> Does you find it somehow misleading?

Apparently in 2019 it's not advertising unless it's misleading...


Insofar as “advertising” is used as a kind of slur against pieces of journalism, it implies a kind of mens rea where the journalist was either paid off, or otherwise intended the piece to serve as PR for the company.

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.)

https://slatestarcodex.com/2014/11/03/all-in-all-another-bri...


It's a puff piece plain and simple, but that doesn't necessarily mean it's misleading.

I'm trying to become a more discerning / critical reader of news stories. Mind expanding on what makes this a "puff piece"?

As far as I can tell the only source for everything written about the company described is the company itself, and of course it's all flatteringly positive and endearing.

Agreed, this article poses no challenging questions, and would be hard to differentiate from PR.



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