2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC403
Submitter : Mrs. Lisa Bazler Date & Time: 12/21/2005 05:12:01
Organization : Mrs. Lisa Bazler
Category : Health Professional
Issue Areas/Comments
Direct to consumer advertising misleads the public by claiming their normal reactions to life experiences *MAY* be caused by chemical imbalances in the brain. But consumers don't hear the 'may' - they hear the overall message the drug companies want them to hear, and they take a pill for a chemical imbalance that doesn't exist.

Since the 1960s, researchers have been unable to prove that any of the 374 mental disorders listed in psychiatry?s bible, the DSM, are caused by chemical imbalances in the brain. Regarding depression, researchers have not been able to prove their theory that any of the depressive disorders is caused by an imbalance of serotonin.

Rather, there is growing skepticism of the chemical imbalance theory, as described in the recent article http://www.eurekalert.org/pub_releases/2005-11/plos-afs103105.php and press release http://medicine.plosjournals.org/perlserv/?request=get- document&doi=10.1371/journal.pmed.0020392 by the non-profit Public Library of Science (PLoS). The authors note that researchers don?t even know the normal amount of serotonin in the brain to begin with, much less how to correct a theoretical imbalance of serotonin. They cite many studies that cast doubt on the theory, but could not find a single study proving the theory. They conclude, 'Far from being a radical line of thought, doubts about the serotonin hypothesis are well acknowledged by many researchers.'

A big tip-off that psychiatry has not proven their chemical imbalance theory lies in the fact that no lab test exists to detect a chemical imbalance in a person?s brain?admitted by American Psychiatric Association President Dr. Steven Sharfstein in the July 11th issue of People magazine. If there were a chemical imbalance, then people would be taking a test to see what chemicals they lack and how much they lack. Instead, people are subjectively interviewed, diagnosed, and prescribed an antidepressant in as little as five minutes, as I have witnessed firsthand as a mental health professional.

With many studies debunking the chemical imbalance theory, and not one study proving it, then we must ask, why would anyone take a drug to correct an imbalance that no one knows is there in the first place? Why would someone diagnosed with depression take an antidepressant, when the antidepressant tries to fix something in the brain that is not broken?

What occurs in the brain when we introduce drugs to try to fix a problem that is not there?when we give a normal brain an abnormal foreign substance? Common sense says the brain will have an adverse reaction, which is exactly what happens. Antidepressants cause chemical imbalances in the brain, and frequently result in outward manifestations of various mental disorders - even suicide and murder, as the FDA has warned with their black box labels.

For these reasons, psychiatric drug direct to consumer advertising is false advertising, pure and simple. These drug companies have made mental conditions physical diseases without a shred of evidence, have convinced the general public that they have a physical disease without an objective test to prove it, and have made billions from their drugs that do nothing more than placebo at best, and have caused the tragic deaths of thousands at worse.

If most doctors don't even know everything about the psychiatric drugs they are prescribing, how can we expect consumers to know? The FDA should ban direct to consumer advertising by drug companies until they can show proof that 1) imbalanced brain chemicals cause mental disorders like depression, 2) an objective lab test exists to show a patient their imbalance, and 3) their drugs are safe and effective. Until this happens, consumers are being subjected to one of the most successful and tragic PR lies in the history of this country.

Thank you for reviewing public comments like these, and please listen to the facts, not the drug companies.

Lisa Bazler, M.A.
Ryan Bazler, MBA