2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC112
Submitter : Mr. Thomas Pula Date & Time: 12/07/2005 06:12:03
Organization : Mr. Thomas Pula
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
'Chemical Imbalance' is the entire basis of the psychiatric industry's justification for the use of SSRIs and other anti-psychotic drugs, the actual mechanics of which are still somewhat uncertain. Thousands of experiments and millions, if not billions, have been invested in the hopes of substantiating this theory, yet no test has ever been discovered or devised that has established any proof of the chemical imbalance theory. And so it remains just that, another theory that may sound logical and may sound educated, but still has no substance.

Yet the drug companies promote this unsubtantiated theory as proven fact in its direct to public advertising. I am not a doctor. I am not a research scientist, but even to me it is very clear that when a theory or 'hope' is promoted as a fact, the scientific method has taken a back seat to fixed ideas or greed, perhaps both.

It is very clear that if a drug is going to be prescribed to treat a physical malady such as a chemical imbalance, then some sort of chemical or medical test must be undertaken to determine that the imbalance does indeed exist. Yet there is no such test. In fact, many prescriptions for these drugs are written by doctors who never even have seen the patients they are writing the prescriptions for!

I believe that the psychiatric drug companies can, and do, undermine the authority and influence of medical doctors and other health care professionals by their misleading and sometimes overtly false advertising directly to the public. And this is particularly true in the field of drugs which allegedly address mental health issues.

It must stop.