Unrealistic optimism means...what?

Pauline Chen writes in the New York Times that patients, particularly those with cancer, who participate in clinical trials are often unrealistic about what their participation actually means. Although many experimental drugs fail to benefit patients -- Chen's estimate is that less than 5% of patients who participate in early-stage trials (as against later-phase trials, which test drugs that have shown promise in early-stage trials) benefit from their treatment. Furthermore, patients who experience no benefit often experience the downsides of treatment in the form of serious, sometimes life-threatening side effects. Yet patients with cancer often assume that they will be the ones who beat the odds -- the so-called "Lake Wobegon" phenomenon ("where everyone is above average").

Chen's argument is often used by supporters of the FDA to say that, thank goodness we have a regulatory agency to make sure that evil pharmaceutical companies won't prey on the hopes of dying patients, and that only drugs that have thoroughly proven, to a regulator's standards, that they work can be given to Americans as a whole.

No.

Yes, it is true that people make mistakes -- and dying people, clinging to any hope they can, may make the mistake of placing more trust in an experimental drug than is warranted. But isn't that their right? A patient who has advanced cancer knows that death -- perhaps even a drawn-out, painful death -- awaits him if he does nothing. Can trying something new and unproven be any worse than that? Even if it can, is it not his body, his life, and his choice to make -- not the choice of some little Washington bureaucrat who doesn't care how many patients die while he waits for the evidence to be presented to his liking?