2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC348
Submitter : Dr. Joseph Valese Date & Time: 12/09/2005 11:12:55
Organization : Dr. Joseph Valese
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL

Dear FDA:
Thank you for this hearing. I do not believe the manufaturers of psych drugs should be allowed to continue their false advertising campaigns. These falsehoods include:
1. that psychiatric drugs handle a "chemical imbalance of the brain" or
similarly, "correct neurotransmitter levels", etc. and;
2. that psychiatric drugs are safe (untrue) and effective (uncertain).
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 such tests to diagnose a brain's chemical balance.
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 these falsehoods from being foisted onto the American public. This is not a freedom of speech in advertising issue.
Please let me know by return email that you understand my comments.
Sincerely,
joevalese@hotmail.com