2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC406
Submitter : Dr. Albert Galves Date & Time: 12/21/2005 05:12:00
Organization : Dr. Albert Galves
Category : Health Professional
Issue Areas/Comments
I have two complaints about the ads for antidepressants. First, since no scientist has established what the chemical balance of neurotransmitters is in the human brain, it is impossible to determine what an imbalance is. In other words, the statement that these drugs correct chemical imbalances is not supported by scientific evidence.

The second is that the ads strongly imply and in some cases state that depression is caused by a deficiency of neurotransmitters. There is no scientific evidence to support such a statement. There is only evidence that there is an association between the symptoms of depression and a deficiency of neurotransmitter. Correlation does not imply causation. There is a mountain of evidence that demonstrates that persons with the following characteristics are vulnerable to depression: having been traumatized, having been abused, having gone through a long period of stress, having diffuculty managing stress, scoring high on the self-defeating scale, depending for well-being on relationships and having recently lost one, etc., etc., etc. Given what we know about other mind-body dynamics such as the stress response, it is much more likely that depression is caused by these psychological variables - thoughts, emotions, perceptions, reactions to life situations and that the chemical dynamics have a mediating rather than a causative role. Thinking depression is caused by neurotransmitter deficiencies is like thinking a home run is caused by a bat. You can't hit a home run without a bat but if a major league manager tried to increase his team's home run production by focusing on the bats, he'd be in big trouble.