2004N-0330 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee
FDA Comment Number : EC39
Submitter : Dr. George Pascarzi Date & Time: 09/16/2004 06:09:54
Organization : Orange County (CA) Heath Care Agency
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
I would hope that if any recommendations/regulations about SSRI's are made, then they should as much as possible emphasize that there are risks taking any medication and that individuals and parents have the right to accept those risks if they think that the benefits outweigh those risks. I applaud your efforts to help get information out that patients and parents can use to make the best decision of risks vs. benfits of medication. The efforts to have a database of all clinical trials will help in that regard. I would also like to see the fact be emphasized that there is risk for adults as well as minors, and that the issue with minors is not totally unique to them. It should be emphasized by the FDA that suicide is in fact a feature of depression in any age, and may be a risk even after treatment has been started in patients of any age. It would thus be good if the FDA action is an advisory about the risk of treatment that would apply to patients of all ages, and that the advisory would include information on the risk of no treatment, the risk of counseling alone as a treatment, and the benefit of medication (in the case of minors, of at least Prozac).

I would like to see the FDA require longer trials of the efficacy of antidepressants. Longer trials, say of 6 months or longer, would help find out if there is a relapse from the placebo effect and whether there is a significant and lasting benefit from the medication. Current studies that are short in length may not be uncover positive benefits over placebo that the medications yield when taken over a longer time and when clinical adjustment of dosages to achieve the best result possible is accomplished. This is the case in studies of depression in adults. Studies that are 4 weeks long do not show the same amount of positive results that studies that are 6 weeks long show. I am not aware of how many studies in adults go as long as I am suggesting, and perhaps the longer studies should be done in adults and minors to try to find out if the benefit of medication vs placebo may be greater than it seems, when time is allowed to see how many patients relapse who are initially responsive to placebo, and to compare that to how many initially respond to medication and continue to repond past the time that placebo responders are failing. I would also like to see the FDA clearly emphazise that in the case at least of Prozac there is now evidence that Prozac is superior to placebo and superior to at least one type of counseling alone. This is important so that the context of risks and benefits be clear to the public and to parents. It is important for the FDA to say that depression is a serious problem and that there is a risk of suicide when depression is untreated, and in this context, when depression is wrongly treated by withholding medication in the mistaken belief that counseling is always safer.

Good luck on your difficult task.

George A. Pascarzi, MD
Board Certified Child/Adolescent Psychiatrist