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I keep on coming back to a very basic element of medical ethics: it's extremely hard to run experiments on pregnant women or little children and not be unethical. For this reason, there is only a tiny number of drugs that are accepted for use on little children or expecting mothers, and even among those many were just grandfathered in based on previous work from time before we realized the potential impacts.

So how did they know all the things they claimed to know, all the things they claimed to know to be true?