I think it does. Ultimately it is a policy decision. There is no exact criteria what should be risk/benefit ratio before we can approve drug for unrestricted (

I think it does. Ultimately it is a policy decision. There is no exact criteria what should be risk/benefit ratio before we can approve drug for unrestricted (but still doctor supervised) use. If we as the society agree that, let's say saving 10 lives at the expense of 1 dead person (just hypothetical example, I am sure the actual benefit is much, much higher), then that's it. If we are more risk averse and demand that for 1 death there should be at least 1000 people saved, then we have a higher bar and that's also ok if the society agrees with it.