3 ms·

They didn't, but that's not a bad thing. The way the process works is that companies give the FDA both summary statistics and underlying data. The FDA can recom

They didn't, but that's not a bad thing. The way the process works is that companies give the FDA both summary statistics and underlying data. The FDA can recompute the stats from the data, confirm they match and approve. The reason for asking for the data isn't because they'll read it, it's so that the summary stats can't be faked without a massive amount of fraud that can be proven if the company lied. Companies can't fake the data because if they got caught, there would be long jail terms and billions of dollars of fines (and they provide too much data for it to be easily forgable).

pfortuny 5y ago
Yeah… good luck with that hope. Have you haerd of Exxon? The Sacklers held on for 20 years on Oxycontin…
- atleta 5y ago
  What does Exxon have to do with the FDA or how medications are authorized? Also, I don't think that the manufacturer of Oxycontin has tricked the authorization process (and then successfully covered up this fact for 20 years). As far as I know, the problem was their marketing strategy, how they convinced doctors (medical practitioners) and probably patients (I can remember the details). So while it's troubling, it's a completely unrelated process and thus unrelated issue.
  - octopoc 5y ago
    > What does Exxon have to do with the FDA or how medications are authorized? It proves that the FDA shouldn't use a "trust, and don't verify" approach to medical trials performed by megacorporations.
    - atleta 5y ago
      Again, what does exactly the Exxon case 'prove' here? Also, how? Which act of theirs? (I'm pretty sure I miss a lot of details there and that might be the reason I have no idea what connection are you drawing here.) Also, no one said "trust and don't verify". What was said is that they don't have to verify all the data and read through all the pages. Because the risk is just too high and they will obviously look into the details here and there.
- adgjlsfhk1 5y ago
  And Oxycontin works, and was correctly approved by the FDA. The problem there wasn't approval, it was how it was used post-approval. That's not an argument that they shouldn't have authorized the drug.
albatross13 5y ago
It is a bad thing. Why would anyone trust Pfizer at this point? https://violationtracker.goodjobsfirst.org/parent/pfizer https://violationtracker.goodjobsfirst.org/parent/pfizer These dudes literally bake "billions in fines" into their operating model, and who cares when their latest and greatest customer puts a gun to everyone's head and says "take pfizer product or lose your livelihood". Billions in fines mean nothing when the federal government guarantees you 15x that in revenue a year.

pfortuny 5y ago

Yeah… good luck with that hope. Have you haerd of Exxon? The Sacklers held on for 20 years on Oxycontin…

atleta 5y ago
What does Exxon have to do with the FDA or how medications are authorized? Also, I don't think that the manufacturer of Oxycontin has tricked the authorization process (and then successfully covered up this fact for 20 years). As far as I know, the problem was their marketing strategy, how they convinced doctors (medical practitioners) and probably patients (I can remember the details). So while it's troubling, it's a completely unrelated process and thus unrelated issue.
- octopoc 5y ago
  > What does Exxon have to do with the FDA or how medications are authorized? It proves that the FDA shouldn't use a "trust, and don't verify" approach to medical trials performed by megacorporations.
  - atleta 5y ago
    Again, what does exactly the Exxon case 'prove' here? Also, how? Which act of theirs? (I'm pretty sure I miss a lot of details there and that might be the reason I have no idea what connection are you drawing here.) Also, no one said "trust and don't verify". What was said is that they don't have to verify all the data and read through all the pages. Because the risk is just too high and they will obviously look into the details here and there.
adgjlsfhk1 5y ago
And Oxycontin works, and was correctly approved by the FDA. The problem there wasn't approval, it was how it was used post-approval. That's not an argument that they shouldn't have authorized the drug.

albatross13 5y ago

It is a bad thing. Why would anyone trust Pfizer at this point? https://violationtracker.goodjobsfirst.org/parent/pfizer https://violationtracker.goodjobsfirst.org/parent/pfizer These dudes literally bake "billions in fines" into their operating model, and who cares when their latest and greatest customer puts a gun to everyone's head and says "take pfizer product or lose your livelihood". Billions in fines mean nothing when the federal government guarantees you 15x that in revenue a year.