[driftdiver]

“I despise Government agencies as much as anyone on here, but Science has rules, and when things are approved without proper study, then the FDA gets crucified for that, too, and then there are Thalidomide headlines and Oxycontin lawsuits.”

This isn’t about studies its about the people. The studies certainly need to be controlled so that medicines work properly. However if someone is gonna die why not allow them to get the experimental drug. They don’t need to be part of the study. If I were in this position I would head to Mexico and buy the drug there.

[catman67]

Funny thing about the Thalidomide tragedy. It’s adverse effects were discovered in Europe before it was approved for use in the US by the FDA. Heard from an FDA old timer that the FDA was on track to give it routine approval, but the paperwork fell behind somebody’s desk and got lost.

Was not discovered until after the adverse effects had appeared in other countries, so the FDA instead touted their diligence in withholding the drug from the US market.

Believe me, the FDA does much more harm than good.

[Gorzaloon]

This isn’t about studies its about the people. The studies certainly need to be controlled so that medicines work properly. However if someone is gonna die why not allow them to get the experimental drug.

I intended that by opting out of the placebo, they would be guaranteed to get the experimental drug, instead of wondering and taking the chance. I hope there would always be enough people who would fear the experimental drug so that there would still be a pool of people willing to be "Controls". The problem is that by self-selecting which group a patient belongs to, any placebo effects would not be part of the results. It's lousy Science, but more humane, and better than having no controls at all.