2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC404
Submitter : Dr. Albert Galves Date & Time: 12/21/2005 05:12:22
Organization : Dr. Albert Galves
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I have two concerns about the advertisements for antidepressant medication. First, the ads claim to correct a chemical imbalance of neurotransmitters in the brain. Since nobody has established what the chemical balance of neurotransmitters is, it is impossible to know what the imbalance is. As Jonathan Leo and Jeffrey LaCasse have argued in their recent article in PLOS, there is virtually no scientific evidence that these medicines correct a chemical imbalance.

My second concern is that these drugs strongly imply (some of them actually state) that depression is caused by a deficiency of certain neurotransmitters. There is absolutely no scientific evidence of that being the case. There is some evidence that depression is associated with deficiency of neurotransmitter. But correlation does not prove causation. It is more likely that the neurotransmitter dynamics are mediating rather than causative. There is a tremendous mountain of evidence demonstrating that people who have been traumatized, have been abused, score high on the self-defeating scale, depend for their well-being on relationships and have recently lost one, have difficulty managing stress, have been under stress for a long time, et., etc., etc. are more vulnerable to depression than others. It is these psychological variables that are the cause of depression. To think that depression is caused by neurotransmitter dynamics is like thinking that a home run is caused by a bat. It is to confuse a mediating variable with a causative one - dangerous indeed. And, more importantly from the standpoint of the FDA's responsibility to regulate advertising, NOT SUPPORTED BY SCIENTIFIC EVIDENCE.