Not really. Side-effects aren't to be observed in a vacuum.

We should be far more concerned about side-effects of a drug intended to treat acne or erectile dysfunction than for drugs targeting life destroyers such as cancer and Alzheimer's.

At some threshold of disease viciousness, society (and the FDA) should relax substantially on the risk-aversion, because the patient is already facing the worst-case scenario.

>At some threshold of disease viciousness, society (and the FDA) should relax substantially on the risk-aversion, because the patient is already facing the worst-case scenario.

This is a fair point, but the rest... well ... still manages to miss the above argument. Side-effects aren't observed in a vacuum, but efficacy is still observed in laboratory conditions, so we really can't comment on whether (or how) this molecule affects other systems.