Here's a follow up story from the Pharmalot blog to a post here yesterday on FDA scrutiny of the accelerated approval program. Bascially, the post concludes that many approvals under the program really come with inadequate clinical trials in terms of safety and effectiveness asssessments.
However, the quandry is that if all drugs required randomized, controlled trials for all drugs -- especially oncology drugs -- the thought is that most of these would be greatly delayed in making these available to patients. Of course if they don't work, what's the problem? It's the other side of the coin. Big delays for drugs that do have clinical value and life-extending effects.
So where do we draw the line? When should we accelerate availability of medicines to dying patients? I suspect we ought to look at the bigger picture and approve based on science and not solely on compassionate grounds. However, it is extremely naive to think that individual dying patients, their families and their advocates are going to like that answer.
Posted by Bruce Lehr Feb 9th 2011.