Now, there are any number of reasons someone might be rejected from the trial. If that happens, the company isn't going to just freely give them the drug anyway, because that wouldn't provide scientifically valid data. Also, no one would enroll in a trial (which carries the potential of getting the placebo) if they could get the treatment outside the trial.
https://astralcodexten.substack.com/p/book-review-from-overs...
> If your lungs can’t breathe well, doctors can put you on a ventilator, which forces air in and out. It’s hard to get ventilators working right. Sometimes they push in too much air and injure your lungs. Sometimes they push in too little air and you suffocate. There are big fights about what settings to run ventilators on for which patients. For a while, doctors fought over whether to set ventilators on high vs. low, with many experts in each camp. Researchers formed a consortium called PETAL to study this.
Then, an institutional review board blocked the study:
> Its director, ethicist Jerry Menikoff, had decided maybe it was unethical to do RCTs on ventilator settings at all. He asked whether they might be able to give every patient the right setting while still doing the study. The study team tried to explain to him that they didn’t know which was the right setting, that was why they had to do the study. He wouldn’t budge.
Yes, putting someone on the wrong ventilator setting could kill them! That's obviously evil! Unfortunately, nobody knew which setting was the wrong one! The only way to find out was to try both, in a systematic and scientifically-valid fashion.
The FDA thinks similarly. In late 2021, they canceled trials of Paxlovid because it was immoral to have a control group. They did not then _waive the trial requirement_, meaning Paxlovid was both too proven to deny but too unproven to be administered.
I understand control groups in general, those are fine. But this is specifically in trials where people are pinning their last hopes out of desperation on some medicine and some random drop of the dice seals their fate.
I'd imagine that somebody who has, say, a 10% chance to die in 3 month, is also quite desperate.
(b) most therapies don't improve prognosis in terminal cases and some make it worse. We don't know which beforehand. In the cases where the therapy makes it worse, was it therefore immoral to not put more people in the control group?
I'd argue the lack of knowledge makes it a wash morally. If we knew beforehand whether the therapy would be effective, we wouldn't need the control group, but we also wouldn't need the study.
Remember that if 10 treatments are being tried at once, you can divide the pool of participants so that only a smallish percentage are part of the control group.