6 ms·

The FDA Hasn't Inspected This Drug Factory After 7 Recalls for the Same Flaw

162 points by hn_acker 2y ago

hn_acker 2y ago
The full title is: > The FDA Hasn’t Inspected This Drug Factory After 7 Recalls for the Same Flaw, 1 Potentially Deadly
s1artibartfast 2y ago
At first look, I agree with the FDA - seems low risk. The LD50 of KCl potassium chloride (like you use for cooking) is approximately 2.5 grams per kilogram (g/kg) when ingested orally. For example, a 165 lb person would have an LD50 of 190 grams. These are 750mg pills. Even if they release all at once, they are still >2 orders of magnitude lower. the daily recommended intake of potassium is 3 grams, or about 6 grams for KCI, or about 8 pills. When I skip meals, I will often drink 750mg of KCI in water for the electrolytes. That said, maybe there are populations which are much more sensitive. I suspect the lawsuit would be more informative to learn more.
- Aloisius 2y ago
  The prescriptions may be for multiple doses per day, to reduce GI irritation. I found a few cases of oral potassium chloride causing heart attacks, though at levels at least an order of magnitude greater.
- wswope 2y ago
  > That said, maybe there are populations which are much more sensitive. I suspect the lawsuit would be more informative to learn more. Yeah, the LD50 is misleading for potassium in this context. Most people can tolerate higher doses completely fine, but people with kidney and cardiac issues can die from doses on the order of ~10g (typically due to arrhythmias/fibrillation). Put another way, the theoretical ratio of LD50 to LD1 is way larger for potassium compared to most other common meds.
- lostbutnotforg 2y ago
  I worked at the salt factory that is the supplier for a lot of these companies. Management is a shit show and their health and safety is trash. We had animals on the property, the staff are poorly trained, and the environment is not conducive to making a good safe product.
  - s1artibartfast 2y ago
    I wouldn't be surprised. I think that is a separate point than the one I was interrogating.
jmclnx 2y ago
What can you say, this is what you get when you cut funding of these agencies over a 20+ year time period. I hear bigger cuts are planned over the next 4 years. If that happens will be a fun times in the US.
- josefritzishere 2y ago
  I have some concerns.
- Kapura 2y ago
  Exactly this. The people in power have been nakedly cutting taxes and cutting expenditures in the regulatory state. This is the obvious, foreseeable result, and we cannot let politicians pretend these things will fix themselves thru magic.
  - WillPostForFood 2y ago
    [flagged]
    - giantg2 2y ago
      I just want to add that the main issue with retaining inspectors is the amount of travel leading to unfavorable work-life balance. Most people do not want to travel 75% of their working time. I imagine the number of people wanting to travel to or relocate to India and China is smaller than those willing to travel or relocate domestically. Then you need qualified people interested in this domain. I image the pool of ideal candidates is extremely small. Recent vacancies are about 10-15%.
    - _DeadFred_ 2y ago
      What are the statics for workload over that period? Facilities monitored and locations? Drug submissions, volumes, complication of submissions now verses 30 years ago, etc?
    - eigen 2y ago
      > FDA spending has gone up every year for the last 30 years, growing from under a billion to over 6 billion. doesn't seem like it based on the FDA Fact Sheets. where are you seeing the annual increases? "The FY 2025 Budget provides a $7.2 billion total program funding level for the U.S. Food and Drug Administration. This includes an overall increase of 7.4 percent or $495 million over the FY 2023 funding level" [1] "The FY 2024 budget provides a $7.2 billion total program level for FDA. " [2] "The FY 2023 budget provides an $8.4 billion total program level for FDA." [3] [1] https://www.fda.gov/media/176923/download https://www.fda.gov/media/176923/download [2] https://www.fda.gov/media/166050/download https://www.fda.gov/media/166050/download [3] https://www.fda.gov/media/157193/download https://www.fda.gov/media/157193/download
likeabatterycar 2y ago
What good will inspecting the factory do? Sounds like a design issue with the pills. They should be questioning some chemist in an office, not observing low caste peasants pouring pill juice into machinery and declaring it all good.
- advisedwang 2y ago
  Every drug, no matter how well designed, can become dangerous with poor quality control during production. Inadequate sterilization, mis-dosing, cheaping out on ingredients, wrong temperatures/times for chemical reactions, broken mixers, you name it. And verifying that a factory has adequate QC doesn't just mean walking the factory floor to check everything is correct (although that is a good start). It also means checking that the factory has a QC program: that management has implemented quality checks and acts on quality issues; that staff are able to flag issues (without retaliation and with reports that get acted on); that they demand the same from suppliers etc etc. We absolutely need the FDA going to factories, not (just) to observe the actual technicians but to inspect the overall way the factory functions wrt quality.
- magneticnorth 2y ago
  From the article: "This became a recurrent theme for Glenmark in subsequent years as FDA investigators dinged one plant after another for failing to follow manufacturing processes that prevent defective drugs from winding up in American medicine cabinets." In the case of potassium pills, they should be quality-testing the extended release mechanism. It's possible an inspector wouldn't be able to catch that their quality testing is shoddy or non-existent in every specific case, but if they show up and see a pattern of bad manufacturing processes, that's important to act on.
hyeonwho4 2y ago
My intuition is that factory inspections should be self-funding, either via tax/fee levies on manufacturers or via fines on factories which fail inspections. How is there a shortage of inspectors? Does FDA not have the authority to fine factories which fail inspections? I have also heard that getting a factory certified as clean for GMP is a huge process. How are foreign factories entering the market if they have never been inspected?
- bluGill 2y ago
  If inspections are self funding you are not inspecting the good guys enough to ensure they don't become bad, or your fines are too low and so offenders are just calling paying the fine a cost of doing business without changing anything.
  - JumpCrisscross 2y ago
    > If inspections are self funding you are not inspecting the good guys enough to ensure they don't become bad Emissions inspections and financial audits are self funding. You pay to get the test because you have to.
    - bluGill 2y ago
      Sometimes they are self funding. In the case you listed they are. however there are lots of different inspections and they all have different funding.
- RachelF 2y ago
  The FDA has to give the factories 90 days notice of an upcoming inspection.
  - hiatus 2y ago
    That is crazy. Restaurants don't get any notice for health inspection, why are drug factories treated differently when the risks are larger? edit: The parent comment is flat-out incorrect. Not sure where you are getting your information from. > FDA inspections are generally unannounced, with a few exceptions. From FDA's "What to expect during an FDA inspection" https://www.fda.gov/media/142762/download https://www.fda.gov/media/142762/download
TheRealPomax 2y ago
The FDA is chronically short on inspectors. Eyebrows shouldn't be raised over the fact that they haven't inspected any particular place -no matter how "know to be problematic"- but that they've been able to perform inspections at all given that the US government is not interested in funding the FDA, and it's only going to get worse over the next 4 years.
- HideousKojima 2y ago
  FDA funding has increased every year for the last 30 years or so. For some reason people like to treat "funding not increased at the rates some group wants" as the same thing as "funding cut"
  - _DeadFred_ 2y ago
    Are people taking more medications than they were 30 years ago? Are there new medications coming out? Are the total number of approved medications that the FDA overseas higher now than 30 years ago? What's the average FDA funding per approved medication today versus 30 years ago? Are the number of manufacturers higher? Are there higher numbers of manufacturers overseas than 30 years ago? Is the submission process more complicated than 30 years ago? Are the medication formulations/manufacturing processes more complicated than 30 years ago? If the supply chain more complicated than 30 years ago?
y-c-o-m-b 2y ago
For the last decade, I've requested my pharmacies to not give me any drugs manufactured in India if possible. I've had issues with many of those brands, Aurobindo being the very first one that gave me problems; which I ended up reporting to the FDA and they got in trouble for quality issues shortly after (I doubt it was from my lone report, but I wonder if that helped). The problem now is almost every generic drug is made in India and I'm having a near impossible time avoiding them. As you can see, they are no longer being properly investigated. What's worse is the pharmacies are also contributing to the problem by not cycling out their stock of older medication. This was evident when I reported one of pharmacies for medication that basically disintegrated into my hands. After they were contacted by state inspectors (I got a follow-up email saying as much), the pills were of noticeably higher quality even though it was the same manufacturer. I honestly suspect a good majority of Americans are using prescription drugs that are either somewhat ineffective or come with side effects that otherwise wouldn't be there with proper inspection. One common thing you'll read online is that "all generic drugs should have the same quality and active ingredient", but clearly that is not accurate when factories are either failing inspection or no longer being inspected at all despite numerous previous failings.
- doctorpangloss 2y ago
  > I've requested my pharmacies to not give me any drugs manufactured in India if possible. Are the brand-names manufactured to a higher spec? Even though you are right - everyone should demand safe generics, because there is no healthcare in any country without them - your words will get lost in the mire of the mind of the libertarian Hacker News 22 year old, who takes no non-stimulant medicines, telling you nobody is forcing you to do this or that, that you should just die.
  - eitally 2y ago
    Supposedly no, but in reality what happens is that when a drug is approved, lots of documentation about that drug + formulation is already published as a result of the R&D processes along with agency oversight in various countries. When a brand name drug goes off patent, everybody (including competitors and generics manufacturers) already has a pretty good idea of both 1) the commercial market for generics, and 2) the components of the drug. What isn't shared are trade secrets disclosing manufacturing processes, as well as the inactive ingredients+formulation of the drug. Competitors & generics OEMs are left to guess and use best judgment when they create competitors to the original, and sometimes they make bad decisions. Actual manufacturing quality should be equally high, but the resulting drug may not end up being exactly the same as the branded version, even if the differences have nothing to do with the active ingredient.
pkaye 2y ago
So how to do other countries deal with these issues? Like Canada, Australia, EU? Do they not purchase drugs from these Indian companies? I presume they do their own inspections?
- sitharus 2y ago
  I only know about New Zealand, and we definitely do source a lot of medications from India. However we have a single payer health system for the most part (you can get medications that aren’t through the system, but you pay full non-US market price), so the big stick is “well we’ll buy from someone else”, easier said than done of course but it seems to work. Our medical regulator (different body to the purchaser) doesn’t do inspections overseas but does random tests on the products imported to check the quality.
fazeirony 2y ago
> The FDA has long said it polices foreign plants by prioritizing inspections based on risk. every time i read something like this - and it is with increasing frequency - i can't help but recall The Formula as laid out in Fight Club. in this case, a few people dead is just 'doing business,' i guess, since it isn't crossing whatever 'n' their threshold is at. which is clearly MUCH greater than 0...
- s1artibartfast 2y ago
  welcome to the real world where zero risk is impossible for any product. These are the risk/benefit tradeoffs at consideration for the FDA. To be clear, the formula laid out in fight club is illegal, and not practice in US medical, but similar tradeoffs are still there. If it is too hard and expensive to reduce risk to an acceptable level, the product isnt made. In many cases, if the product isnt made, more people die than if the product has residual risk.
- pas 2y ago
  the US and EU could do a mutual acceptance of each others drug marketing authorizations. but it's messy, so there's no political will. USA first anyway. (and the pharma industry probably likes it this way.) and even then ... the industry is complex, costs are high, funding is always finite, keeping product quality consistently high is a lot of effort, which is definitely not cheap, etc. many generics "don't break even" as far as I understand there's a lot of potential for having some kind of centralized mass-manufacturing setup of these low-profit drugs. but the cautionary tale is the baby formula brouhaha. it shouldn't be a single point of failure. but then it's not that low cost, right? so it should be some kind of industry-wide system. (ie. every big manufacturer should have some capacity that is pooled for these. but it must not hinder the market, it must not be a barrier to entry, and it must not lead to manufacturers exiting the market. so many considerations and challenges.)
  - polymatter 2y ago
    What’s the “baby formula brouhaha”?
exmadscientist 2y ago
That's interesting. The only medication quality issue I have ever had has been... Glenmark XR tablets that refused to dissolve properly and gave me massive dose spikes. In my case this wasn't KCl, so I survived, but I did have severe vision problems for an hour or so. More than once. The other generic vendor who supplied that medication in this area had no such issues for the exact same drug and dosage. And I've been left with extra eye floaters that have never gone away since the last incident. Fuck you, Glenmark. At least I barely notice them most of the time. It turns out there is no way in the US (at least according to my doctor) to write a prescription as "anything but Glenmark", so I was out of luck for that prescription. Fortunately I can take the immediate release version at only a minor convenience hit, so that's sorted. Still... very frustrating. I guess I should have filed an FDA complaint. It's always hard to know what's "my problem" and what's actually their fault.
- jart 2y ago
  You have permanent floaters in your eyes because you took bad pills? Wait what?
  - exmadscientist 2y ago
    Yep! The explanation I've gotten is that the bad pills gave me a massive salt dose very quickly, raising my blood pressure sharply. This increased the pressure on my eyeballs, of all things, producing visual effects indistinguishable from a scintillating scotoma (but not actually those, because it's really coming from the eyeballs themselves, not the brain). The pressure difference crushed my eyeballs slightly and ruptured blood vessels, releasing floaters. They have gotten better over the last couple years but they are definitely still there. Fuck Glenmark.
    - jart 2y ago
      Thanks for sharing your story. Wow that sounds brutal. Almost sounds like having a blotch on your eyeglasses you can't clean. Do the floaters move around in your vision too? Because if they stay in one place, I imagine it could be tuned out, like your said, but it would be incredibly distracting if it moved.
creer 2y ago
The concern should be that they are not in control of their manufacturing. NOT that the flaws discovered are low priority or that the product is low risk or that they actually do recalls or whatever. The lack of manufacturing control is the actual flaw. And because of lack of control it's pretty likely that an inspection would uncover more problems. We see this all the time: people point out that a problem is minor, therefore not a big deal. Or we see a food manufacturer poisoning a bunch of people with product X produced in factory 123. And so inspectors are eventually sent to the shut-down section 123-X (where they uncover a million other problems.) And no inspectors are sent to section 123-Y or 123-Z or any other factory. No tests are performed on other products out in the distribution channel. That to me is insanity. The uncaught manufacturing problems do not happen out of acts of god, randomly, as some inevitability. They are not caught because management and staff do not care and test and check for them. They are not random instances but likely highly correlated with other problems. Because the root is lack of care and lack of control. In the case of a food or pharma manufacturer caught with their pants down, ANY such instance should be the cause of a major call to order within the company. That one instance is a symptom of lack of management and staff effectiveness. Any lesser reaction should be the call for them getting to the top of the inspection priority list worldwide. And this very specifically is absurdly insufficient: > “When there are quality issues identified that could result in harm, patients should rest assured that the FDA does everything within our authority to work with firms to ensure a recall is conducted most effectively,” Or after inspection at ONE factory: > “Your quality system for investigations is inadequate and does not ensure consistent production of safe and effective products,” How can this NOT be taken as a sign that the other factories are likely also affected? Which is why for me any such lack of response (company-wide call to arms) results in the company going on the blacklist. ... Which does make shopping difficult.
nytesky 2y ago
Eye drops were a recent problem too https://www.bbc.com/news/world-asia-india-65171851.amp https://www.bbc.com/news/world-asia-india-65171851.amp

162 points by hn_acker 2y ago

The full title is: > The FDA Hasn’t Inspected This Drug Factory After 7 Recalls for the Same Flaw, 1 Potentially Deadly

At first look, I agree with the FDA - seems low risk. The LD50 of KCl potassium chloride (like you use for cooking) is approximately 2.5 grams per kilogram (g/kg) when ingested orally. For example, a 165 lb person would have an LD50 of 190 grams. These are 750mg pills. Even if they release all at once, they are still >2 orders of magnitude lower. the daily recommended intake of potassium is 3 grams, or about 6 grams for KCI, or about 8 pills. When I skip meals, I will often drink 750mg of KCI in water for the electrolytes. That said, maybe there are populations which are much more sensitive. I suspect the lawsuit would be more informative to learn more.

Aloisius 2y ago
The prescriptions may be for multiple doses per day, to reduce GI irritation. I found a few cases of oral potassium chloride causing heart attacks, though at levels at least an order of magnitude greater.
wswope 2y ago
> That said, maybe there are populations which are much more sensitive. I suspect the lawsuit would be more informative to learn more. Yeah, the LD50 is misleading for potassium in this context. Most people can tolerate higher doses completely fine, but people with kidney and cardiac issues can die from doses on the order of ~10g (typically due to arrhythmias/fibrillation). Put another way, the theoretical ratio of LD50 to LD1 is way larger for potassium compared to most other common meds.
lostbutnotforg 2y ago
I worked at the salt factory that is the supplier for a lot of these companies. Management is a shit show and their health and safety is trash. We had animals on the property, the staff are poorly trained, and the environment is not conducive to making a good safe product.
- s1artibartfast 2y ago
  I wouldn't be surprised. I think that is a separate point than the one I was interrogating.

jmclnx 2y ago

What can you say, this is what you get when you cut funding of these agencies over a 20+ year time period. I hear bigger cuts are planned over the next 4 years. If that happens will be a fun times in the US.

josefritzishere 2y ago
I have some concerns.
Kapura 2y ago
Exactly this. The people in power have been nakedly cutting taxes and cutting expenditures in the regulatory state. This is the obvious, foreseeable result, and we cannot let politicians pretend these things will fix themselves thru magic.
- WillPostForFood 2y ago
  [flagged]
  - giantg2 2y ago
    I just want to add that the main issue with retaining inspectors is the amount of travel leading to unfavorable work-life balance. Most people do not want to travel 75% of their working time. I imagine the number of people wanting to travel to or relocate to India and China is smaller than those willing to travel or relocate domestically. Then you need qualified people interested in this domain. I image the pool of ideal candidates is extremely small. Recent vacancies are about 10-15%.
  - _DeadFred_ 2y ago
    What are the statics for workload over that period? Facilities monitored and locations? Drug submissions, volumes, complication of submissions now verses 30 years ago, etc?
  - eigen 2y ago
    > FDA spending has gone up every year for the last 30 years, growing from under a billion to over 6 billion. doesn't seem like it based on the FDA Fact Sheets. where are you seeing the annual increases? "The FY 2025 Budget provides a $7.2 billion total program funding level for the U.S. Food and Drug Administration. This includes an overall increase of 7.4 percent or $495 million over the FY 2023 funding level" [1] "The FY 2024 budget provides a $7.2 billion total program level for FDA. " [2] "The FY 2023 budget provides an $8.4 billion total program level for FDA." [3] [1] https://www.fda.gov/media/176923/download https://www.fda.gov/media/176923/download [2] https://www.fda.gov/media/166050/download https://www.fda.gov/media/166050/download [3] https://www.fda.gov/media/157193/download https://www.fda.gov/media/157193/download

likeabatterycar 2y ago

What good will inspecting the factory do? Sounds like a design issue with the pills. They should be questioning some chemist in an office, not observing low caste peasants pouring pill juice into machinery and declaring it all good.

advisedwang 2y ago
Every drug, no matter how well designed, can become dangerous with poor quality control during production. Inadequate sterilization, mis-dosing, cheaping out on ingredients, wrong temperatures/times for chemical reactions, broken mixers, you name it. And verifying that a factory has adequate QC doesn't just mean walking the factory floor to check everything is correct (although that is a good start). It also means checking that the factory has a QC program: that management has implemented quality checks and acts on quality issues; that staff are able to flag issues (without retaliation and with reports that get acted on); that they demand the same from suppliers etc etc. We absolutely need the FDA going to factories, not (just) to observe the actual technicians but to inspect the overall way the factory functions wrt quality.
magneticnorth 2y ago
From the article: "This became a recurrent theme for Glenmark in subsequent years as FDA investigators dinged one plant after another for failing to follow manufacturing processes that prevent defective drugs from winding up in American medicine cabinets." In the case of potassium pills, they should be quality-testing the extended release mechanism. It's possible an inspector wouldn't be able to catch that their quality testing is shoddy or non-existent in every specific case, but if they show up and see a pattern of bad manufacturing processes, that's important to act on.

hyeonwho4 2y ago

My intuition is that factory inspections should be self-funding, either via tax/fee levies on manufacturers or via fines on factories which fail inspections. How is there a shortage of inspectors? Does FDA not have the authority to fine factories which fail inspections? I have also heard that getting a factory certified as clean for GMP is a huge process. How are foreign factories entering the market if they have never been inspected?

bluGill 2y ago
If inspections are self funding you are not inspecting the good guys enough to ensure they don't become bad, or your fines are too low and so offenders are just calling paying the fine a cost of doing business without changing anything.
- JumpCrisscross 2y ago
  > If inspections are self funding you are not inspecting the good guys enough to ensure they don't become bad Emissions inspections and financial audits are self funding. You pay to get the test because you have to.
  - bluGill 2y ago
    Sometimes they are self funding. In the case you listed they are. however there are lots of different inspections and they all have different funding.
RachelF 2y ago
The FDA has to give the factories 90 days notice of an upcoming inspection.
- hiatus 2y ago
  That is crazy. Restaurants don't get any notice for health inspection, why are drug factories treated differently when the risks are larger? edit: The parent comment is flat-out incorrect. Not sure where you are getting your information from. > FDA inspections are generally unannounced, with a few exceptions. From FDA's "What to expect during an FDA inspection" https://www.fda.gov/media/142762/download https://www.fda.gov/media/142762/download

TheRealPomax 2y ago

The FDA is chronically short on inspectors. Eyebrows shouldn't be raised over the fact that they haven't inspected any particular place -no matter how "know to be problematic"- but that they've been able to perform inspections at all given that the US government is not interested in funding the FDA, and it's only going to get worse over the next 4 years.

HideousKojima 2y ago
FDA funding has increased every year for the last 30 years or so. For some reason people like to treat "funding not increased at the rates some group wants" as the same thing as "funding cut"
- _DeadFred_ 2y ago
  Are people taking more medications than they were 30 years ago? Are there new medications coming out? Are the total number of approved medications that the FDA overseas higher now than 30 years ago? What's the average FDA funding per approved medication today versus 30 years ago? Are the number of manufacturers higher? Are there higher numbers of manufacturers overseas than 30 years ago? Is the submission process more complicated than 30 years ago? Are the medication formulations/manufacturing processes more complicated than 30 years ago? If the supply chain more complicated than 30 years ago?

y-c-o-m-b 2y ago

For the last decade, I've requested my pharmacies to not give me any drugs manufactured in India if possible. I've had issues with many of those brands, Aurobindo being the very first one that gave me problems; which I ended up reporting to the FDA and they got in trouble for quality issues shortly after (I doubt it was from my lone report, but I wonder if that helped). The problem now is almost every generic drug is made in India and I'm having a near impossible time avoiding them. As you can see, they are no longer being properly investigated. What's worse is the pharmacies are also contributing to the problem by not cycling out their stock of older medication. This was evident when I reported one of pharmacies for medication that basically disintegrated into my hands. After they were contacted by state inspectors (I got a follow-up email saying as much), the pills were of noticeably higher quality even though it was the same manufacturer. I honestly suspect a good majority of Americans are using prescription drugs that are either somewhat ineffective or come with side effects that otherwise wouldn't be there with proper inspection. One common thing you'll read online is that "all generic drugs should have the same quality and active ingredient", but clearly that is not accurate when factories are either failing inspection or no longer being inspected at all despite numerous previous failings.

doctorpangloss 2y ago
> I've requested my pharmacies to not give me any drugs manufactured in India if possible. Are the brand-names manufactured to a higher spec? Even though you are right - everyone should demand safe generics, because there is no healthcare in any country without them - your words will get lost in the mire of the mind of the libertarian Hacker News 22 year old, who takes no non-stimulant medicines, telling you nobody is forcing you to do this or that, that you should just die.
- eitally 2y ago
  Supposedly no, but in reality what happens is that when a drug is approved, lots of documentation about that drug + formulation is already published as a result of the R&D processes along with agency oversight in various countries. When a brand name drug goes off patent, everybody (including competitors and generics manufacturers) already has a pretty good idea of both 1) the commercial market for generics, and 2) the components of the drug. What isn't shared are trade secrets disclosing manufacturing processes, as well as the inactive ingredients+formulation of the drug. Competitors & generics OEMs are left to guess and use best judgment when they create competitors to the original, and sometimes they make bad decisions. Actual manufacturing quality should be equally high, but the resulting drug may not end up being exactly the same as the branded version, even if the differences have nothing to do with the active ingredient.

pkaye 2y ago

So how to do other countries deal with these issues? Like Canada, Australia, EU? Do they not purchase drugs from these Indian companies? I presume they do their own inspections?

sitharus 2y ago
I only know about New Zealand, and we definitely do source a lot of medications from India. However we have a single payer health system for the most part (you can get medications that aren’t through the system, but you pay full non-US market price), so the big stick is “well we’ll buy from someone else”, easier said than done of course but it seems to work. Our medical regulator (different body to the purchaser) doesn’t do inspections overseas but does random tests on the products imported to check the quality.

fazeirony 2y ago

> The FDA has long said it polices foreign plants by prioritizing inspections based on risk. every time i read something like this - and it is with increasing frequency - i can't help but recall The Formula as laid out in Fight Club. in this case, a few people dead is just 'doing business,' i guess, since it isn't crossing whatever 'n' their threshold is at. which is clearly MUCH greater than 0...

s1artibartfast 2y ago
welcome to the real world where zero risk is impossible for any product. These are the risk/benefit tradeoffs at consideration for the FDA. To be clear, the formula laid out in fight club is illegal, and not practice in US medical, but similar tradeoffs are still there. If it is too hard and expensive to reduce risk to an acceptable level, the product isnt made. In many cases, if the product isnt made, more people die than if the product has residual risk.
pas 2y ago
the US and EU could do a mutual acceptance of each others drug marketing authorizations. but it's messy, so there's no political will. USA first anyway. (and the pharma industry probably likes it this way.) and even then ... the industry is complex, costs are high, funding is always finite, keeping product quality consistently high is a lot of effort, which is definitely not cheap, etc. many generics "don't break even" as far as I understand there's a lot of potential for having some kind of centralized mass-manufacturing setup of these low-profit drugs. but the cautionary tale is the baby formula brouhaha. it shouldn't be a single point of failure. but then it's not that low cost, right? so it should be some kind of industry-wide system. (ie. every big manufacturer should have some capacity that is pooled for these. but it must not hinder the market, it must not be a barrier to entry, and it must not lead to manufacturers exiting the market. so many considerations and challenges.)
- polymatter 2y ago
  What’s the “baby formula brouhaha”?

exmadscientist 2y ago

That's interesting. The only medication quality issue I have ever had has been... Glenmark XR tablets that refused to dissolve properly and gave me massive dose spikes. In my case this wasn't KCl, so I survived, but I did have severe vision problems for an hour or so. More than once. The other generic vendor who supplied that medication in this area had no such issues for the exact same drug and dosage. And I've been left with extra eye floaters that have never gone away since the last incident. Fuck you, Glenmark. At least I barely notice them most of the time. It turns out there is no way in the US (at least according to my doctor) to write a prescription as "anything but Glenmark", so I was out of luck for that prescription. Fortunately I can take the immediate release version at only a minor convenience hit, so that's sorted. Still... very frustrating. I guess I should have filed an FDA complaint. It's always hard to know what's "my problem" and what's actually their fault.

jart 2y ago
You have permanent floaters in your eyes because you took bad pills? Wait what?
- exmadscientist 2y ago
  Yep! The explanation I've gotten is that the bad pills gave me a massive salt dose very quickly, raising my blood pressure sharply. This increased the pressure on my eyeballs, of all things, producing visual effects indistinguishable from a scintillating scotoma (but not actually those, because it's really coming from the eyeballs themselves, not the brain). The pressure difference crushed my eyeballs slightly and ruptured blood vessels, releasing floaters. They have gotten better over the last couple years but they are definitely still there. Fuck Glenmark.
  - jart 2y ago
    Thanks for sharing your story. Wow that sounds brutal. Almost sounds like having a blotch on your eyeglasses you can't clean. Do the floaters move around in your vision too? Because if they stay in one place, I imagine it could be tuned out, like your said, but it would be incredibly distracting if it moved.

creer 2y ago

The concern should be that they are not in control of their manufacturing. NOT that the flaws discovered are low priority or that the product is low risk or that they actually do recalls or whatever. The lack of manufacturing control is the actual flaw. And because of lack of control it's pretty likely that an inspection would uncover more problems. We see this all the time: people point out that a problem is minor, therefore not a big deal. Or we see a food manufacturer poisoning a bunch of people with product X produced in factory 123. And so inspectors are eventually sent to the shut-down section 123-X (where they uncover a million other problems.) And no inspectors are sent to section 123-Y or 123-Z or any other factory. No tests are performed on other products out in the distribution channel. That to me is insanity. The uncaught manufacturing problems do not happen out of acts of god, randomly, as some inevitability. They are not caught because management and staff do not care and test and check for them. They are not random instances but likely highly correlated with other problems. Because the root is lack of care and lack of control. In the case of a food or pharma manufacturer caught with their pants down, ANY such instance should be the cause of a major call to order within the company. That one instance is a symptom of lack of management and staff effectiveness. Any lesser reaction should be the call for them getting to the top of the inspection priority list worldwide. And this very specifically is absurdly insufficient: > “When there are quality issues identified that could result in harm, patients should rest assured that the FDA does everything within our authority to work with firms to ensure a recall is conducted most effectively,” Or after inspection at ONE factory: > “Your quality system for investigations is inadequate and does not ensure consistent production of safe and effective products,” How can this NOT be taken as a sign that the other factories are likely also affected? Which is why for me any such lack of response (company-wide call to arms) results in the company going on the blacklist. ... Which does make shopping difficult.

nytesky 2y ago

Eye drops were a recent problem too https://www.bbc.com/news/world-asia-india-65171851.amp https://www.bbc.com/news/world-asia-india-65171851.amp