2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC18
Submitter : Mr. Harold A. Maio Date & Time: 11/18/2005 02:11:31
Organization : Mr. Harold A. Maio
Category : Individual Consumer
Issue Areas/Comments
In direct to consumer advertising for medications for mental disorders, the catch-phrase 'chemical imbalance' alleges as real an unproven theory.

Drug-marketers have so powerfully and redundantly presented the allegation, that it is now a public myth influencing the medical professions themselves. Doctors believing the advertising, prescribe drugs based upon Madison Avenue hype seeking neither studies nor proof.

So convincing has the advertising become, that even federal agencies dealing with mental health are repeating the claim. State governments are as well, and universities are teaching the myth.

Until scientific, blind, and independent studies are performed, the claim must be withdawn.

Harold A. Maio khmaio@earthlink.net