That's an interesting story actually, and tells more about the regulatory environment in the US than it does about pharma companies.
In short, a very rare adverse event was observed in clinical trials, but it lacked the statistical relevance to justify an inclusion in the label. J&J suggested including it during draft labeling discussions with the FDA, but FDA said it should not be included. J&J was later sued over the deaths, and a judge determined that J&J was at fault because they knew there was some chance of these events occurring. That a different government body told them not to do it didn't absolve them of any liability, even though the drug would have never made it to market if J&J didn't do what FDA wanted.
COVID vaccines are no different. Even though the pharma companies involved aren't exactly moral, their profit motivations are simple and expected. But the other half of responsible parties include government agencies like FDA, who exist solely to protect the consumer, while also being entirely funded by the taxpayer. They have utterly failed at their one job, and we'd never be in this situation to start with if they had done what we pay them to do.
As someone working for a pharma company very little the FDA does makes any sense. We recently doubled our batch sizes and only one test out of dozens for the same product had to have the sample size doubled, and that only doubled because the drum size didn't change.
When I asked my boss about it she said "it has nothing to do with logic and science, that's what the FDA says we have to do"
That's an interesting story actually, and tells more about the regulatory environment in the US than it does about pharma companies.
In short, a very rare adverse event was observed in clinical trials, but it lacked the statistical relevance to justify an inclusion in the label. J&J suggested including it during draft labeling discussions with the FDA, but FDA said it should not be included. J&J was later sued over the deaths, and a judge determined that J&J was at fault because they knew there was some chance of these events occurring. That a different government body told them not to do it didn't absolve them of any liability, even though the drug would have never made it to market if J&J didn't do what FDA wanted.
COVID vaccines are no different. Even though the pharma companies involved aren't exactly moral, their profit motivations are simple and expected. But the other half of responsible parties include government agencies like FDA, who exist solely to protect the consumer, while also being entirely funded by the taxpayer. They have utterly failed at their one job, and we'd never be in this situation to start with if they had done what we pay them to do.
As someone working for a pharma company very little the FDA does makes any sense. We recently doubled our batch sizes and only one test out of dozens for the same product had to have the sample size doubled, and that only doubled because the drum size didn't change.
When I asked my boss about it she said "it has nothing to do with logic and science, that's what the FDA says we have to do"