2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC35
Submitter : Mr. Stephen McCrea Date & Time: 11/18/2005 02:11:27
Organization : Mr. Stephen McCrea
Category : Health Professional
Issue Areas/Comments
I am glad the FDA is reviewing its policy regarding DTC advertising for pharmaceuticals. I am appalled by the degree of deception that is allowable in DTC advertising about products that can have serious ill effects on the body. In particular, I am very disturbed by advertising for psychiartic drugs that state or imply that mental illness is caused by "chemical imbalances" that the psychiatric drugs somehow "fix" or "rebalance". These statements are deceptive and scientifically unsupportable. For starters, there is no scientific method to determine what a proper "chemical balance" would look like. Given this, it is absurd to suggest that a "chemical imbalance" either exists or is remediated by any medication. Furthermore, evidence is still lacking to support the idea that mental illness is solely or even primarily caused by any particular problem in the brain. While there may be some cases where brain injuries or dysfunctions are causitive, there is not one single mental illness that is identifiable by genetic or chemical or any other scientific test that would physiologically distinguish the "menally ill" from the "mentally healthy". The DSM-IV diagnoses used to justify these medical interventions are subjective descriptions of behavior and emotional states that are not necessarily associated with a particular physiological problem. These misrepresentations of fact may divert people from seeking the real reasons and real solutions for their mental or emotional problems, and create pressure on doctors to prescribe drugs rather than encouraging lifestyle changes or therapy that might actually empower their clients to improve their life functioning.

Given all of this, I would urge a ban on DTC advertising of prescription pharmaceuticals, and in particular, psychotropic drugs of any type. Barring this, I would strongly urge a ban on any use of the concept of the "chemical imbalance" being used in any advertisements for pharmaceuticals purporting to treat mental disorders. I am extremely concerned by the trends I am seeing. I hope you will reconsider DTC advertising, as it appears to be detrimental to positive healthcare decisions.