David Healy-April 15, 2013
“This is not an evidence based position. It can only begin to possibly make sense on the basis of some belief about an effectiveness that conveniently for regulators is rarely put to the test – the WHI HRT and NIH tolbutamide trials were monumentally inconvenient for regulators but even they didn’t lead to the drugs being pulled. That’s a medical issue not a regulatory issue.
Truly effective treatments should be self-funding or even lead to a fall in healthcare costs. If lives are saved and people are put back to work, or become more efficient at work, then national economies will perform better and wealth will increase. But not only are healthcare costs increasing exponentially, morbidity and mortality from treatment is increasing so that treatment induced death is heading toward being, may even be, the normative way of dying.
None of this should be happening if our treatments are effective. RCTs, as used by companies, may be efficacious to get drugs on the market but for the most part they aren’t effective in leading to better health.”
Along the same timeline the Community Mental Health Act of 1963 was passed-and we suddenly had subjects for RTCs.