2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC21
Submitter : Ms. Pamela Wheelock Date & Time: 11/18/2005 02:11:12
Organization : Ms. Pamela Wheelock
Category : Health Professional
Issue Areas/Comments
I have been an occupational therapist for a number of years. I taught a masters and bachelor's level course in the OT dept at Westen Michigan University for 3 years. I taught a class called Disabling Conditions for 6 semesters. In that course we covered mental health concerns. I have also worked as a mental health advocate in New York State for the MHA.

I do not find the use of chemical imbalance as a way to describe depression as very useful-- instead it seems a way to broaden a market share. There are no specific diagnostic tools to interpret this "imbalance", to tell if one is " out of balance", or "in balance". Many consumers admit they feel different when taking SSRI's and other anti-depressents but this difference does not always lead to a lack of sadness or anxiety. By talking generally about a chemical imbalance without any tools for testing, the manufacturers of these meds are establishing psuedo authority over what a healthy chemical imbalance might look like and then proposing to be the cure for the type of illness they have described.

I know many lay people who do not understand that no healthy chemical balance can be established or proven. They do not understand the contstantly fluctuating nature of the synapsis transmitter waltz. Indeed-- it seems the ultimate silliness to me that one might provide a recipe for happiness that looks like: 1 part serotonin, 1 part norepinephrin, etc. Even the DSM declares that depression is a natural human condition and that we should be careful in declaring it an illness treatable by pills.

This moves me to my last point. In my work as an OT I work with people to understand their options and see how to produce productive functional solutions. It is a fool hardy solution to sit and wait for one's meds to cure a black box version of chemical imbalance but, by perpetrating the image of a medical definitive such as "chemcial imbalance" and by only giving pills for a solution, this is exactly what happens. I have seen people who have lived with states of depression in the past without meds-- struggled but regained thier lives-- slide deeper under the influence of the "chemical imbalance" doctrine. They sit and wait. They are seldom if ever told about exercise, talk therapy, routine, sharing with others. Instead they are given thier little white persecription order and sent home. We know exercise, etc is crucial to assisting in lifting serious depression but even doctors have fallen prey to the pure meds protocol and have forgotten it is only one peice-- if you read it over and over again in ads it must be so.

For consumers and professionals it is crucial that the sales person not be able to establish untracable criteria and then propose they cure those criteria. I am tired of being swamped with all these sales pitches. I can't go to the doctor, watch TV, read magazines, etc without being drowned in the idea that the condtion of sadness and despair are about my brain chemicals. Show me one emotion or thought that is not.

Thanks Pam Wheelock, MS/OTR