7 ms·

This almost read like a bot wrote it... > A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The m

This almost read like a bot wrote it... > A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug. It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage. They don't name the manufacturer, the drug, or really much of anything.

drugones 7y ago
Maybe in purpose to avoid drugs related panic purchases.
- rubber_duck 7y ago
  Why publish anything then ?
  - taywrobel 7y ago
    Because otherwise once shortages begin they'll be accused of a "cover-up"?
  - ydnaclementine 7y ago
    So they can't say you they didn't tell you anything
  - wyldfire 7y ago
    Well, we know that there is a disruption and that as far as the FDA knows it's just the one report so far. In an administration that frequently gets involved in cover-ups, you can't fault the FDA for trying to disclose as much as they can without causing new problems. Plus the press release goes on to detail many other areas of FDA's regulatory domain that are also helpful.
    - TheSpiceIsLife 7y ago
      This this other comment (not mine) detailing these FDAs transparency re drug shortages: https://news.ycombinator.com/item?id=22445961 https://news.ycombinator.com/item?id=22445961
- zerkten 7y ago
  This is what I'd expect having worked for ~10 years in pharma. These companies are very sensitive to announcements like these because they can be misinterpreted by the public/media. They'll be trying to find some alternative options and the details of the shortage will become evident from other sources eventually.
deleted 7y ago
[deleted]
frisco 7y ago
This is called “Special English” aka “Simple English” or “Voice of America English”. It is meant to be very clear and straightforward to understand to minimize the possibility of miscommunication and make it so that non-experts of all backgrounds can take away the important messages. Given how important the medicine supply chain is to lots of people’s daily lives, I’m sure they didn’t want this page to seem understandable only by the educated. https://en.m.wikipedia.org/wiki/Special_English https://en.m.wikipedia.org/wiki/Special_English
- metalliqaz 7y ago
  That's interesting, thanks. Non mobile link: https://en.wikipedia.org/wiki/Special_English https://en.wikipedia.org/wiki/Special_English
- gizmo385 7y ago
  Is there anything similar in other languages? I would love to have a similar resource for my German learning.
  - tomjakubowski 7y ago
    I'm also interested in this question of "Special $LANG" for other languages. For German learners, DW has a daily podcast Langsam gesprochene Nachrichten ("News read slowly"), which I have found invaluable. https://m.dw.com/de/deutsch-lernen/nachrichten/s-8030 https://m.dw.com/de/deutsch-lernen/nachrichten/s-8030
  - teagee 7y ago
    Linguistica 360 has news in slow ____ for a number of languages https://www.linguistica360.com/ https://www.linguistica360.com/
  - yorwba 7y ago
    The equivalent term is "leichte Sprache". https://en.wikipedia.org/wiki/Leichte_Sprache https://en.wikipedia.org/wiki/Leichte_Sprache The websites of government agencies usually have a version in leichter Sprache, although it tends to be counterproductively hidden. The NDR offers news using leichte Sprache: https://www.ndr.de/fernsehen/service/leichte_sprache/ https://www.ndr.de/fernsehen/service/leichte_sprache/ Edit: or any of the other sites on this list: https://bpb.de/politik/grundfragen/politik-einfach-fuer-alle/245442/webseiten-mit-nachrichten-in-einfacher-oder-leichter-sprache https://bpb.de/politik/grundfragen/politik-einfach-fuer-alle... Further edit: there's a Wikipedia category for simplified languages, which in addition to English and German also has Latin and French: https://en.wikipedia.org/wiki/Category:Simplified_languages https://en.wikipedia.org/wiki/Category:Simplified_languages
dfsegoat 7y ago
FDA has an entire drug shortage database that is updated daily and publicly accessible. There are tons of drug shortages at any given time, and most of them go back to API (Active Pharm Ingredients) - the raw active chemicals produced in bulk, that are then put into pills, injection solutions etc. You could probably figure it out from there. My guess is it would be irresponsible for them to name the Mfgr in the press release, particularly if it were a publicly traded company and people are going to jump to uninformed conclusions. https://www.accessdata.fda.gov/scripts/drugshortages/ https://www.accessdata.fda.gov/scripts/drugshortages/ Supply chain security has also been a major focus at FDA over the last ~5 years, basically to ensure there are not "choke points" with respect to approved medicines: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/are-you-ready-drug-supply-chain-security-act https://www.fda.gov/drugs/drug-supply-chain-security-act-dsc... So in general, I appreciate their transparency on this since they have been building up regs around this very type of issue for awhile.
- adrianmonk 7y ago
  > My guess is it would be irresponsible for them to name the Mfgr in the press release, particularly if it were a publicly traded company and people are going to jump to uninformed conclusions. Not only could it harm the company, it could be bad for patients. Naming it could cause a run (https://en.wikipedia.org/wiki/Market_run https://en.wikipedia.org/wiki/Market_run) on the drug, and if some people hoard it, there will be other people who are unable to get it.
  - TeMPOraL 7y ago
    And even worse than the hoarders: the sudden appearance of "entrepreneurs" smelling easy profit.
    - adrianmonk 7y ago
      Price gouging? Of drugs? In the United States?
      - 7y ago
orblivion 7y ago
> This almost read like a bot wrote it... Particularly with reference to "a human drug"
- Seenso 7y ago
  > Particularly with reference to "a human drug" Veterinary drugs are a thing, and it appears the FDA regulates them, too: https://www.fda.gov/animal-veterinary/resources-you/fda-regulation-animal-drugs https://www.fda.gov/animal-veterinary/resources-you/fda-regu...
  - wh1t3n01s3 7y ago
    Human drug it’s just a drug. Only if it’s not ‘human’ you have to specify.
    - Mountain_Skies 7y ago
      Purchasing over the counter animal drugs for use in humans is somewhat common in prepper communities. Perhaps the wording was aimed at them.
    - samatman 7y ago
      That's certainly true if you're an ordinary person. If you're the person who writes press releases for an organization which regulates both human and animal drugs, then you have a reason to be specific.
- deleted 7y ago
  [deleted]
throwaway9878 7y ago
California looks set to explode into another Italy scenario as local, human-to-human transmission now appears to be taking place in Solano County, where a woman now critically ill with the coronavirus previously exposed dozens of hospital workers in two hospitals. She was not tested for 11 days because the CDC’s testing flow chart excludes the testing of people who contract the virus in America and who didn’t visit China. The Governor of California stated yesterday that California has only around 200 test kits for the entire state. To this very day, there is virtually zero testing of anyone happening in the entire United States — a fact that many people still are unable to believe (they remain in total denial). The SF Chronicle also confirms this story. According to a highly disturbing Wall Street Journal story (https://www.wsj.com/articles/whistleblower-says-federal-employees-flown-from-coronavirus-sites-didnt-follow-safety-protocols-11582840144 https://www.wsj.com/articles/whistleblower-says-federal-empl...) federal employees who ran the quarantine sites in California and elsewhere failed to wear proper protective equipment (PPE) and also weren’t trained in how to handle people exposed to the virus. Most disturbingly, as the WSJ subhead says, “Employees weren’t tested for virus before leaving California quarantine sites on commercial flights.” I am astounded by the frequency of idiots in key decision making positions globally.
- anarazel 7y ago
  A lot of the US problems around covid handling seem to be coordination related. There used to be coordinating personnel specifically for that at the NSC. But that has been slashed over the last few years. That kind of short sightedness drives me nuts.

drugones 7y ago

Maybe in purpose to avoid drugs related panic purchases.

rubber_duck 7y ago
Why publish anything then ?
- taywrobel 7y ago
  Because otherwise once shortages begin they'll be accused of a "cover-up"?
- ydnaclementine 7y ago
  So they can't say you they didn't tell you anything
- wyldfire 7y ago
  Well, we know that there is a disruption and that as far as the FDA knows it's just the one report so far. In an administration that frequently gets involved in cover-ups, you can't fault the FDA for trying to disclose as much as they can without causing new problems. Plus the press release goes on to detail many other areas of FDA's regulatory domain that are also helpful.
  - TheSpiceIsLife 7y ago
    This this other comment (not mine) detailing these FDAs transparency re drug shortages: https://news.ycombinator.com/item?id=22445961 https://news.ycombinator.com/item?id=22445961
zerkten 7y ago
This is what I'd expect having worked for ~10 years in pharma. These companies are very sensitive to announcements like these because they can be misinterpreted by the public/media. They'll be trying to find some alternative options and the details of the shortage will become evident from other sources eventually.

deleted 7y ago

[deleted]

frisco 7y ago

This is called “Special English” aka “Simple English” or “Voice of America English”. It is meant to be very clear and straightforward to understand to minimize the possibility of miscommunication and make it so that non-experts of all backgrounds can take away the important messages. Given how important the medicine supply chain is to lots of people’s daily lives, I’m sure they didn’t want this page to seem understandable only by the educated. https://en.m.wikipedia.org/wiki/Special_English https://en.m.wikipedia.org/wiki/Special_English

metalliqaz 7y ago
That's interesting, thanks. Non mobile link: https://en.wikipedia.org/wiki/Special_English https://en.wikipedia.org/wiki/Special_English
gizmo385 7y ago
Is there anything similar in other languages? I would love to have a similar resource for my German learning.
- tomjakubowski 7y ago
  I'm also interested in this question of "Special $LANG" for other languages. For German learners, DW has a daily podcast Langsam gesprochene Nachrichten ("News read slowly"), which I have found invaluable. https://m.dw.com/de/deutsch-lernen/nachrichten/s-8030 https://m.dw.com/de/deutsch-lernen/nachrichten/s-8030
- teagee 7y ago
  Linguistica 360 has news in slow ____ for a number of languages https://www.linguistica360.com/ https://www.linguistica360.com/
- yorwba 7y ago
  The equivalent term is "leichte Sprache". https://en.wikipedia.org/wiki/Leichte_Sprache https://en.wikipedia.org/wiki/Leichte_Sprache The websites of government agencies usually have a version in leichter Sprache, although it tends to be counterproductively hidden. The NDR offers news using leichte Sprache: https://www.ndr.de/fernsehen/service/leichte_sprache/ https://www.ndr.de/fernsehen/service/leichte_sprache/ Edit: or any of the other sites on this list: https://bpb.de/politik/grundfragen/politik-einfach-fuer-alle/245442/webseiten-mit-nachrichten-in-einfacher-oder-leichter-sprache https://bpb.de/politik/grundfragen/politik-einfach-fuer-alle... Further edit: there's a Wikipedia category for simplified languages, which in addition to English and German also has Latin and French: https://en.wikipedia.org/wiki/Category:Simplified_languages https://en.wikipedia.org/wiki/Category:Simplified_languages

dfsegoat 7y ago

FDA has an entire drug shortage database that is updated daily and publicly accessible. There are tons of drug shortages at any given time, and most of them go back to API (Active Pharm Ingredients) - the raw active chemicals produced in bulk, that are then put into pills, injection solutions etc. You could probably figure it out from there. My guess is it would be irresponsible for them to name the Mfgr in the press release, particularly if it were a publicly traded company and people are going to jump to uninformed conclusions. https://www.accessdata.fda.gov/scripts/drugshortages/ https://www.accessdata.fda.gov/scripts/drugshortages/ Supply chain security has also been a major focus at FDA over the last ~5 years, basically to ensure there are not "choke points" with respect to approved medicines: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/are-you-ready-drug-supply-chain-security-act https://www.fda.gov/drugs/drug-supply-chain-security-act-dsc... So in general, I appreciate their transparency on this since they have been building up regs around this very type of issue for awhile.

adrianmonk 7y ago
> My guess is it would be irresponsible for them to name the Mfgr in the press release, particularly if it were a publicly traded company and people are going to jump to uninformed conclusions. Not only could it harm the company, it could be bad for patients. Naming it could cause a run (https://en.wikipedia.org/wiki/Market_run https://en.wikipedia.org/wiki/Market_run) on the drug, and if some people hoard it, there will be other people who are unable to get it.
- TeMPOraL 7y ago
  And even worse than the hoarders: the sudden appearance of "entrepreneurs" smelling easy profit.
  - adrianmonk 7y ago
    Price gouging? Of drugs? In the United States?
    - 7y ago

orblivion 7y ago

> This almost read like a bot wrote it... Particularly with reference to "a human drug"

Seenso 7y ago
> Particularly with reference to "a human drug" Veterinary drugs are a thing, and it appears the FDA regulates them, too: https://www.fda.gov/animal-veterinary/resources-you/fda-regulation-animal-drugs https://www.fda.gov/animal-veterinary/resources-you/fda-regu...
- wh1t3n01s3 7y ago
  Human drug it’s just a drug. Only if it’s not ‘human’ you have to specify.
  - Mountain_Skies 7y ago
    Purchasing over the counter animal drugs for use in humans is somewhat common in prepper communities. Perhaps the wording was aimed at them.
  - samatman 7y ago
    That's certainly true if you're an ordinary person. If you're the person who writes press releases for an organization which regulates both human and animal drugs, then you have a reason to be specific.
deleted 7y ago
[deleted]

throwaway9878 7y ago

California looks set to explode into another Italy scenario as local, human-to-human transmission now appears to be taking place in Solano County, where a woman now critically ill with the coronavirus previously exposed dozens of hospital workers in two hospitals. She was not tested for 11 days because the CDC’s testing flow chart excludes the testing of people who contract the virus in America and who didn’t visit China. The Governor of California stated yesterday that California has only around 200 test kits for the entire state. To this very day, there is virtually zero testing of anyone happening in the entire United States — a fact that many people still are unable to believe (they remain in total denial). The SF Chronicle also confirms this story. According to a highly disturbing Wall Street Journal story (https://www.wsj.com/articles/whistleblower-says-federal-employees-flown-from-coronavirus-sites-didnt-follow-safety-protocols-11582840144 https://www.wsj.com/articles/whistleblower-says-federal-empl...) federal employees who ran the quarantine sites in California and elsewhere failed to wear proper protective equipment (PPE) and also weren’t trained in how to handle people exposed to the virus. Most disturbingly, as the WSJ subhead says, “Employees weren’t tested for virus before leaving California quarantine sites on commercial flights.” I am astounded by the frequency of idiots in key decision making positions globally.

anarazel 7y ago
A lot of the US problems around covid handling seem to be coordination related. There used to be coordinating personnel specifically for that at the NSC. But that has been slashed over the last few years. That kind of short sightedness drives me nuts.