2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC376
Submitter : Mr. David Potter Date & Time: 12/12/2005 02:12:31
Organization : None
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
With Prozac and the SSRIs that followed, their level of efficacy was always of a very minor sort. In all the clinical trials of the antidepressants, roughly 41 percent of the patients got better in the short term versus 31 percent of the patients on placebo. Now just one other caveat on that. If you use an active placebo in these trials -- an active placebo causes a physiologic change with no benefit, like a dry mouth -- any difference in outcome between the antidepressant and placebo virtually disappears.