4 ms·

Quality control has limits, if you only test some samples you are likely to miss issues. Especially as there is a wide variety of potential problems, and you ca

Quality control has limits, if you only test some samples you are likely to miss issues. Especially as there is a wide variety of potential problems, and you can't easily test for all of them. That is why the processes themselves are regulated, and not just the products. And the issues here are not just onerous paperwork. This is the company shredding documentation that would otherwise show that they had data that indicated potential issues, but which they ignored.

jacksnipe 3y ago
I think what you’re missing here is that generics are already approved with pretty large deviations in e.g. serum response from the underlying approved drug, but without re-testing. So the current system is already producing bad-for-consumer outcomes at a rapid pace.
- bamfly 3y ago
  Can confirm, the generic for the adhd med a couple of my kids take is super obviously not even close to as good as the real thing. Took us a little bit to put 2 and 2 together the first time we got that instead of the "real thing", but that was definitely the problem. Of course we still end up with the generic a lot, what with the shortage, and just have to deal with it barely-working instead of being wonderfully effective, until we get to roll the dice again 30 days later and hope we luck into name-brand pills being available. Makes one wonder about, you know, all the other generics.
  - meepmorp 3y ago
    Is this a time release drug, like Concerta?
    - jacksnipe 3y ago
      I wouldn’t be surprised. Concerta (osmotic time release) is so much more effective than normal generics (non-osmotic time release) that they shouldn’t even be considered the same drug.
      - bamfly 3y ago
        Yeah, our experience is something like: unmedicated << generic <<<<<<<<<<<<<<<<<<<<<<<<<<<<< name brand in terms of perceived effect. They're sure as hell not close enough to be considered equivalent under any reasonable classification scheme (but I assume insurers really, really, really want the generic to count as equivalent and work to ensure it is so-regarded—and, anyway, availability's so spotty that we just have to take what we can get regardless).
        jacksnipe 3y ago
        As a patient this was also my experience.
    - bamfly 3y ago
      Yeah. The generics use a different ER mechanism, which is surely part of the problem, but others report issues with non-ER versions, too, presumably due either to purity/consistency issues or different filler material, so I doubt the ER difference is the only problem—we did use name brand non-ER at first before switching to extended release, and that wasn't even close to as ineffective as generics of the ER. I've read (but not confirmed) that some adhd generics are also allowed to use cheaper-to-manufacture almost-but-not-quite-identical isomers that haven't been tested and may have significantly worse efficacy, though, no clue if that affects ours (or if that's even true, really).
A_D_E_P_T 3y ago
> Especially as there is a wide variety of potential problems, and you can't easily test for all of them. Such as? Most quality issues in drugs -- purity, composition, dissolution rate, presence of mycotoxins, etc. -- are very, very easily testable. What's more, most of the things that are not easily testable would not be picked up in a facilities inspection.

jacksnipe 3y ago

I think what you’re missing here is that generics are already approved with pretty large deviations in e.g. serum response from the underlying approved drug, but without re-testing. So the current system is already producing bad-for-consumer outcomes at a rapid pace.

bamfly 3y ago
Can confirm, the generic for the adhd med a couple of my kids take is super obviously not even close to as good as the real thing. Took us a little bit to put 2 and 2 together the first time we got that instead of the "real thing", but that was definitely the problem. Of course we still end up with the generic a lot, what with the shortage, and just have to deal with it barely-working instead of being wonderfully effective, until we get to roll the dice again 30 days later and hope we luck into name-brand pills being available. Makes one wonder about, you know, all the other generics.
- meepmorp 3y ago
  Is this a time release drug, like Concerta?
  - jacksnipe 3y ago
    I wouldn’t be surprised. Concerta (osmotic time release) is so much more effective than normal generics (non-osmotic time release) that they shouldn’t even be considered the same drug.
    - bamfly 3y ago
      Yeah, our experience is something like: unmedicated << generic <<<<<<<<<<<<<<<<<<<<<<<<<<<<< name brand in terms of perceived effect. They're sure as hell not close enough to be considered equivalent under any reasonable classification scheme (but I assume insurers really, really, really want the generic to count as equivalent and work to ensure it is so-regarded—and, anyway, availability's so spotty that we just have to take what we can get regardless).
      - jacksnipe 3y ago
        As a patient this was also my experience.
  - bamfly 3y ago
    Yeah. The generics use a different ER mechanism, which is surely part of the problem, but others report issues with non-ER versions, too, presumably due either to purity/consistency issues or different filler material, so I doubt the ER difference is the only problem—we did use name brand non-ER at first before switching to extended release, and that wasn't even close to as ineffective as generics of the ER. I've read (but not confirmed) that some adhd generics are also allowed to use cheaper-to-manufacture almost-but-not-quite-identical isomers that haven't been tested and may have significantly worse efficacy, though, no clue if that affects ours (or if that's even true, really).

A_D_E_P_T 3y ago

> Especially as there is a wide variety of potential problems, and you can't easily test for all of them. Such as? Most quality issues in drugs -- purity, composition, dissolution rate, presence of mycotoxins, etc. -- are very, very easily testable. What's more, most of the things that are not easily testable would not be picked up in a facilities inspection.