2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC391
Submitter : Mr. daniel fish Date & Time: 12/13/2005 09:12:25
Organization : Mr. daniel fish
Category : Individual Consumer
Issue Areas/Comments
Dear FDA:
Thank you for this hearing. My problem isn't so much that drug companies advertise, but in the case of psychiatric drugs, the FDA allows them to make unfounded and unscientific claims and lie to the public.

1. that psychiatric drugs handle a "chemical imbalance of the brain" or similarly, "correct neurotransmitter levels" has not been scientifically proven.
2. that psychiatric drugs are safe and effective is invalidated by the laundrylist of side effects of each of their drugs and that the long term harm of these drugs has not been scientifically been researched.
Regarding #1 above, psychiatrists don't know what a proper chemical balance is , so therefore cannot say what is an improper balance, especially when they have no scientific tests to diagnose a brain's chemical balance. And they have no scientific tool that would determine whether the persons upset is caused by a physical imbalance in the brain or the accumulated stress caused by life in general. I.e.: is the wiring bad or is there just bad progamming.
In regards to #2 above, these drugs have many severe effects and side effects so are not safe. The FDA approves these psychiatric drugs although they barely beat out the placebo and often lose out to excercise in helping depression.
It's time you, the FDA, stop allowing the lies and unfounded non scientific claims as opposed to looking at the Unconstitutional alternative solution of denying the freedom of speech to advertise.
Please let me know by return email that you understand my comments.
D.P. Fish