2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC366
Submitter : Ms. Mary Bordeaux Date & Time: 12/09/2005 11:12:19
Organization : CCHR
Category : Individual Consumer
Issue Areas/Comments
Dear FDA,
Thank you for having this hearing. It isn't really a question of whether drug companies advertise, but in the case of psychiatric drugs, the FDA is currently allowing them to present blatant lies. The Lies include:

1. That psychiatric drugs handle a "chemical imbalance of the brain" or similarly, "correct neurotransmitter levels", etc. -- By their own admission (of the President of the APA), Psychiatrists don't know what constitutes a proper chemical balance so therefore cannot say what is an improper balance, especially when they have no such tests to diagnose a brain's chemical balance. Such a thing has never been established.

2. that psychiatric drugs are safe (lie) and effective (lie). -- These drugs have many side effects, including many severe side effects, and so could never be properly represented as safe. The FDA approves these psychiatric drugs although they barely beat out the placebo and often less effective than mere physical excercise in helping depression.

You, the FDA, must stop allowing the lies, using the excuse and under the guise of allowing freedom of speech in advertisements.

I look forward to your reply.

Mary Bordeaux
Montrose, CA