2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC212
Submitter : Mr. Richard Warner Date & Time: 12/07/2005 06:12:57
Organization : Mr. Richard Warner
Category : Individual Consumer
Issue Areas/Comments
Current advertising of psychiatric drugs is highly misleading and constitutes a gross violation of basic principals of informed consent. Claims are made for these drugs which are not supported by medical science - indeed the weight of evidence is exactly in the opposite direction. When we are dealing with life and death issues -as we clearly are with depression and antidepressant drugs which can double the rate of suicidal ideation - drug companies should not be allowed to use suggestion and innuendo to deliberately mislead consumers. In view of the fact that 1) we are dealing with often complex medical issues, 2) psychiatric symptoms can be produced by a host of real physical illnesses and by psychiatric and non-psychiatric drugs themselves, and 3) there is no laboratory test that can establish the existence of psychiatric disorders, the risk of continuing to allow the mass advertising of psychiatric drugs far exceeds any slight benefit and should be discontinued. The FDA needs to act now!