What makes this even worse is that one key principle in responsible drug development is that safety takes greater priority, and so even marginal safety signals need to be taken very seriously, when you’re dealing with a medicine that 1) treats a less serious condition and 2) treats a larger population.
For example, if you have a treatment for a rare, very fatal cancer that only 100 people nationwide have, then a 1.7% imbalance in serious adverse events means about 2 extra people nationwide end up in the hospital or at risk of death from a side effect, and those people were on death’s door to begin with - you’re probably willing to roll the dice on that safety risk to get the benefit of treatment when the alternative is certain death from cancer.
And then on the other extreme, where we are here, where you’ve got a medicinal product that’s going to be given to millions of healthy babies who don’t even have an illness, to protect them against an illness that they’ll likely never get, and that is still pretty survivable if they get it, then a 1.7% imbalance in SAEs means tens of thousands of hospitalized / dead babies, for the very marginal benefit of protecting them against something they don’t have, probably won’t ever get, and could probably survive in the unlikely event they get it.
That’s what pissed me off so much about the Covid vaccines. This whole principle, which is embedded in the broader principle of balancing likely treatment benefits against risks, went out the fucking window because we live in clown world now and Pfizer needed to hit its profit targets.
What makes this even worse is that one key principle in responsible drug development is that safety takes greater priority, and so even marginal safety signals need to be taken very seriously, when you’re dealing with a medicine that 1) treats a less serious condition and 2) treats a larger population.
For example, if you have a treatment for a rare, very fatal cancer that only 100 people nationwide have, then a 1.7% imbalance in serious adverse events means about 2 extra people nationwide end up in the hospital or at risk of death from a side effect, and those people were on death’s door to begin with - you’re probably willing to roll the dice on that safety risk to get the benefit of treatment when the alternative is certain death from cancer.
And then on the other extreme, where we are here, where you’ve got a medicinal product that’s going to be given to millions of healthy babies who don’t even have an illness, to protect them against an illness that they’ll likely never get, and that is still pretty survivable if they get it, then a 1.7% imbalance in SAEs means tens of thousands of hospitalized / dead babies, for the very marginal benefit of protecting them against something they don’t have, probably won’t ever get, and could probably survive in the unlikely event they get it.
That’s what pissed me off so much about the Covid vaccines. This whole principle, which is embedded in the broader principle of balancing likely treatment benefits against risks, went out the fucking window because we live in clown world now and Pfizer needed to hit its profit targets.