Posted by Alan on September 22, 2002, at 22:50:41
In reply to dont start » Alan, posted by pharmrep on September 22, 2002, at 11:11:57
There should be a law requiring that as one requirement for getting a drug approved, all data on formal and informal trials in humans must be placed into the public domain.
For a long time (and still to some extent), the makers of recent antidepressants have been able to hide the known adverse effects and the fact that the the drugs have performed no better (and often worse) than placebo in a majority of their trials.
I was reading an analysis recently which stated that if you took the entire population of people to whom SSRIs are administered after a diagnosis of clinical depression and then you screened them by the criteria used for selecting patients for clinical trials, 90% of them would be excluded from participation in such trials. So they aren't typical enough to go into the research, but then researchers turn around and make recommendations based on a sample representing 10% of the population of interest and apply those recommendations to 100% of the population of interest.
A large proportion of that 100% probably has a brain chemistry more like that of healthy volunteers than like that of the patients in the clinical trials. Thus one would expect the (highly problematic) healthy-volunteer trials to be more predictive of results than the clinical trials based on criteria that include only 10% of prospective users.
Comments?
poster:Alan
thread:109458
URL: http://www.dr-bob.org/babble/20020922/msgs/120783.html