7 ms·

A tiny pharmacy is identifying problems with common drugs

139 points by pujjad 7y ago

neonate 7y ago
http://archive.is/KCfQu http://archive.is/KCfQu Edit: try also https://outline.com/ykCXfg https://outline.com/ykCXfg https://web.archive.org/web/20191108165301/https://www.washingtonpost.com/science/a-tiny-pharmacy-is-identifying-big-problems-with-common-drugs-including-zantac/2019/11/08/6dd009ca-eb76-11e9-9c6d-436a0df4f31d_story.html https://web.archive.org/web/20191108165301/https://www.washi...
- pmoriarty 7y ago
  Is there an archive of this article that doesn't require Javascript?
  - PhantomGremlin 7y ago
    Firefox + NoScript + No Previous Cookies (from anyone) --> no problem reading the original article.
    - pmoriarty 7y ago
      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.
      - PhantomGremlin 7y ago
        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!
        upofadown 7y ago
        >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.
        aquabeagle 7y ago
        It's in ports/packages now, but it used to be in base.
  - deleted 7y ago
    [deleted]
- whycombagator 7y ago
  I get a 404 visiting that link...
  - Jerry2 7y ago
    You're probably using Cloudflare's DNS resolver.
    - jbotz 7y ago
      And, so, why? What's Clouflare doing wrong?
      - pmh 7y ago
        https://news.ycombinator.com/item?id=19828317 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
        Jerry2 7y ago
        >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-1-1-1-1-not-resolve-archive-is https://webapps.stackexchange.com/questions/135222/why-does-...
liveoneggs 7y ago
nice ad
- DoofusOfDeath 7y ago
  It does paint a compelling picture of the problem and a company that provides a solution. Does you find it somehow misleading?
  - newnewpdro 7y ago
    > Does you find it somehow misleading? Apparently in 2019 it's not advertising unless it's misleading...
    - derefr 7y ago
      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-brick-in-the-motte/ https://slatestarcodex.com/2014/11/03/all-in-all-another-bri...
victor106 7y ago
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.
- uxp 7y ago
  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.
  - gus_massa 7y ago
    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.
tvanantwerp 7y ago
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/ https://peterattiamd.com/davidlight/
ars 7y ago
Alternate sources: https://www.mysanantonio.com/news/article/A-tiny-pharmacy-raises-big-doubts-about-our-drugs-14820025.php https://www.mysanantonio.com/news/article/A-tiny-pharmacy-ra... https://www.scientificamerican.com/article/what-we-know-about-the-possible-carcinogen-found-in-zantac/ https://www.scientificamerican.com/article/what-we-know-abou...
dm319 7y ago
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.
refurb 7y ago
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.
- gus_massa 7y ago
  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.
  - refurb 7y ago
    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-updates-and-press-announcements-ndma-zantac-ranitidine 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-MS-Ranitidine-Data-Report_v6.2.pdf 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.
audiometry 7y ago
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.

139 points by pujjad 7y ago

http://archive.is/KCfQu http://archive.is/KCfQu Edit: try also https://outline.com/ykCXfg https://outline.com/ykCXfg https://web.archive.org/web/20191108165301/https://www.washingtonpost.com/science/a-tiny-pharmacy-is-identifying-big-problems-with-common-drugs-including-zantac/2019/11/08/6dd009ca-eb76-11e9-9c6d-436a0df4f31d_story.html https://web.archive.org/web/20191108165301/https://www.washi...

pmoriarty 7y ago
Is there an archive of this article that doesn't require Javascript?
- PhantomGremlin 7y ago
  Firefox + NoScript + No Previous Cookies (from anyone) --> no problem reading the original article.
  - pmoriarty 7y ago
    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.
    - PhantomGremlin 7y ago
      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!
      - upofadown 7y ago
        >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.
        aquabeagle 7y ago
        It's in ports/packages now, but it used to be in base.
- deleted 7y ago
  [deleted]
whycombagator 7y ago
I get a 404 visiting that link...
- Jerry2 7y ago
  You're probably using Cloudflare's DNS resolver.
  - jbotz 7y ago
    And, so, why? What's Clouflare doing wrong?
    - pmh 7y ago
      https://news.ycombinator.com/item?id=19828317 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
      - Jerry2 7y ago
        >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-1-1-1-1-not-resolve-archive-is https://webapps.stackexchange.com/questions/135222/why-does-...

liveoneggs 7y ago

nice ad

DoofusOfDeath 7y ago
It does paint a compelling picture of the problem and a company that provides a solution. Does you find it somehow misleading?
- newnewpdro 7y ago
  > Does you find it somehow misleading? Apparently in 2019 it's not advertising unless it's misleading...
  - derefr 7y ago
    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-brick-in-the-motte/ https://slatestarcodex.com/2014/11/03/all-in-all-another-bri...

victor106 7y ago

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.

uxp 7y ago
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.
- gus_massa 7y ago
  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.

tvanantwerp 7y ago

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/ https://peterattiamd.com/davidlight/

ars 7y ago

Alternate sources: https://www.mysanantonio.com/news/article/A-tiny-pharmacy-raises-big-doubts-about-our-drugs-14820025.php https://www.mysanantonio.com/news/article/A-tiny-pharmacy-ra... https://www.scientificamerican.com/article/what-we-know-about-the-possible-carcinogen-found-in-zantac/ https://www.scientificamerican.com/article/what-we-know-abou...

dm319 7y ago

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.

refurb 7y ago

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.

gus_massa 7y ago
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.
- refurb 7y ago
  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-updates-and-press-announcements-ndma-zantac-ranitidine 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-MS-Ranitidine-Data-Report_v6.2.pdf 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.

audiometry 7y ago

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.