It seems to me much more likely that the Chinese are doing human trials that skip animal testing then that the US intelligence community does that.
Terminally ill patients don’t make good subjects for clinical trials. If you run such a project outside of the reach of the FDA, it seems like a slight against the FDA. It’s not a step in which companies that produce vaccines and that want to have good relationships with the FDA want to make.
On the other hand the Chinese government has plenty of people in their prisons that they consider expandable and willing to sacrifice for the greater good. They should also have less institutional resistance to it
The “terminally ill” bit was part of the (probably false) rumor that I heard. Preexisting illness definitely screws with the safety-testing aspect, but there are also illnesses don’t interfere with the efficacy testing. I agree that a competent agency uses healthy people for this if they could. If experimenting on healthy people wasn’t possible or worth it, one possibility would be to do an efficacy trial on unhealthy people and a safety study on animals in parallel.
I have the impression that you ignore the institutional issues that are at play. The intelligence community can’t simply deploy a vaccine on their own. They need buy in from the FDA.
Legally speak, yes they would. Practically speaking, however, the FDA has no enforcement power over secret programs in the intelligence community.
I think a lot of people are seriously overestimating the FDA’s actual power, and that’s causing pretty severe problems. Consider for example this tweet (and a long series like it) by the mayor of NYC, begging the FDA for approvals. While there is no legal precedent to refer to, it’s extremely implausible that the FDA could ever get or enforce a judgment of the city of New York for actions taken during a state of emergency, when the FDA itself caused that emergency with culpable negligence.
The FDA has no power to stop the intelligence community running tests on patients but they do have the power to declare the results of the tests as not being enough to prove the resulting vaccines safe.
Do you really think that you have a better idea of the institutional power of the various players then the mayor of NYC? The FDA has a lot of relationships that allow it to exert power that are distinct from direct legal tools.
It seems to me much more likely that the Chinese are doing human trials that skip animal testing then that the US intelligence community does that.
Terminally ill patients don’t make good subjects for clinical trials. If you run such a project outside of the reach of the FDA, it seems like a slight against the FDA. It’s not a step in which companies that produce vaccines and that want to have good relationships with the FDA want to make.
On the other hand the Chinese government has plenty of people in their prisons that they consider expandable and willing to sacrifice for the greater good. They should also have less institutional resistance to it
The “terminally ill” bit was part of the (probably false) rumor that I heard. Preexisting illness definitely screws with the safety-testing aspect, but there are also illnesses don’t interfere with the efficacy testing. I agree that a competent agency uses healthy people for this if they could. If experimenting on healthy people wasn’t possible or worth it, one possibility would be to do an efficacy trial on unhealthy people and a safety study on animals in parallel.
I have the impression that you ignore the institutional issues that are at play. The intelligence community can’t simply deploy a vaccine on their own. They need buy in from the FDA.
Legally speak, yes they would. Practically speaking, however, the FDA has no enforcement power over secret programs in the intelligence community.
I think a lot of people are seriously overestimating the FDA’s actual power, and that’s causing pretty severe problems. Consider for example this tweet (and a long series like it) by the mayor of NYC, begging the FDA for approvals. While there is no legal precedent to refer to, it’s extremely implausible that the FDA could ever get or enforce a judgment of the city of New York for actions taken during a state of emergency, when the FDA itself caused that emergency with culpable negligence.
The FDA has no power to stop the intelligence community running tests on patients but they do have the power to declare the results of the tests as not being enough to prove the resulting vaccines safe.
Do you really think that you have a better idea of the institutional power of the various players then the mayor of NYC? The FDA has a lot of relationships that allow it to exert power that are distinct from direct legal tools.