2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC330
Submitter : Mr. Tom Hughes Date & Time: 12/09/2005 11:12:55
Organization : Mr. Tom Hughes
Category : Drug Industry
Issue Areas/Comments
Dear FDA:
Thank you for this hearing. I have concern that drug companies are not being honest in their advertising, in the case of psychiatric drugs. The FDA allows this to happen.
These are some examples:
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 (untrue).
Regarding #1 above, psychiatrists don't know what a proper chemical imblance 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.
I beleive It's time you, the FDA, stop allowing untruth, as opposed to looking at the Unconstitutional alternative solution of denying the freedom of speech to advertise.
Please return email that you understand my concerns.
Tom Hughes
Waltham, Massachusetts