Comment by derektank
Comment by derektank 2 days ago
It seems like FDA restrictions on clinical trials have really shot us all in the foot by depriving us the opportunity to collect data on this bacteria before it was made available as a supplement. There is clearly a demand for this product and it seems quite likely that Hillman et al could have gotten a cohort together to conduct a trial if they hadn't been faced with such extreme restrictions on testing. Why is informed consent not sufficient for participation in a RCT?
Because the participants could very easily spread it to other people. This wouldn’t just affect them. That’s why the trial was ultimately required to take place under quarantine.
It’s not even a question of whether it would spread, but whether it might spread. There’s a reasonable chance that this bacterium would, in fact, spread, and nobody has proven otherwise.
The FDA is doing its job here: it’s protecting the masses from people who believe they’re just consenting for themselves.