> because higher-dose or adjuvanted influenza vaccines are recommended for older adults, Moderna’s use of a standard-dose comparator rendered the trial not “adequate and well-controlled.” If that requirement had been clear from the outset ....
How can that requirement not be obvious from the start? This isn't some deeply technical issue nobody could have predicted, even a layman can see that this issue would invalidate the trials.
I think the reality is much more grim: regulators under left wing governments allow vaccine companies to get away with literally anything because leftists experience a brain crash if someone accuses them of being an anti-vaxxer, which they interpret to mean any position that isn't maximally pro-vaccine. So of course standards decay to zero. Then people who don't suffer this problem come into power and start reimposing standards, yielding "regulatory uncertainty".
The practice of comparing vaccines against other vaccines is catastrophic for trust in the technology. They should be compared against saline controls (or simply no placebo at all). The argument for using other vaccines as a placebo is ridiculous on its face, and it's easy to see how it can go wrong. The FDA isn't even talking about that issue at the moment, they're just trying to impose the very bare minimum of equalizing the doses.
This may be more relevant to the more bad scenario, but I think it is worth bringing up generally. In a democracy like the United States, regulators are supposed to be accountable to voters. The FDA, like every other executive branch agency, reports ultimately to the president, who is elected by the people. And so when the people elect a new president, that is supposed to cause new behavior by regulators across the government, including at the FDA. And for better or worse, in the last election, Americans elected a president who had said he would put an idiot in charge of HHS (of which FDA is a component), and he did. So I think there is a significant tension here between the democratic requirement that the behavior of regulators change after an election, and the scientific utility of having regulators behave in predictable ways. I'd like to hear how you think about that tension.
I'm wondering if there are ways to develop drugs that are compatible with an FDA that changes course every four years. Ideas off the top of my head, which are not particularly well thought out or necessarily endorsed:
- make trials fast enough that they can be completed in under four years
- do trials in another country first, learn which drugs actually work outside the US, and then after the companies know the answer they can run trials in the US to satisfy the FDA
> because higher-dose or adjuvanted influenza vaccines are recommended for older adults, Moderna’s use of a standard-dose comparator rendered the trial not “adequate and well-controlled.” If that requirement had been clear from the outset ....
How can that requirement not be obvious from the start? This isn't some deeply technical issue nobody could have predicted, even a layman can see that this issue would invalidate the trials.
I think the reality is much more grim: regulators under left wing governments allow vaccine companies to get away with literally anything because leftists experience a brain crash if someone accuses them of being an anti-vaxxer, which they interpret to mean any position that isn't maximally pro-vaccine. So of course standards decay to zero. Then people who don't suffer this problem come into power and start reimposing standards, yielding "regulatory uncertainty".
The practice of comparing vaccines against other vaccines is catastrophic for trust in the technology. They should be compared against saline controls (or simply no placebo at all). The argument for using other vaccines as a placebo is ridiculous on its face, and it's easy to see how it can go wrong. The FDA isn't even talking about that issue at the moment, they're just trying to impose the very bare minimum of equalizing the doses.
What a disgrace!
Cheers for fighting the good fight!
This may be more relevant to the more bad scenario, but I think it is worth bringing up generally. In a democracy like the United States, regulators are supposed to be accountable to voters. The FDA, like every other executive branch agency, reports ultimately to the president, who is elected by the people. And so when the people elect a new president, that is supposed to cause new behavior by regulators across the government, including at the FDA. And for better or worse, in the last election, Americans elected a president who had said he would put an idiot in charge of HHS (of which FDA is a component), and he did. So I think there is a significant tension here between the democratic requirement that the behavior of regulators change after an election, and the scientific utility of having regulators behave in predictable ways. I'd like to hear how you think about that tension.
I'm wondering if there are ways to develop drugs that are compatible with an FDA that changes course every four years. Ideas off the top of my head, which are not particularly well thought out or necessarily endorsed:
- make trials fast enough that they can be completed in under four years
- do trials in another country first, learn which drugs actually work outside the US, and then after the companies know the answer they can run trials in the US to satisfy the FDA
- drop the requirement to show efficacy entirely
- pay attention to what the opposition are saying even if out of power and then meet their standards as well.
Or let the States form independent regulators