2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC128
Submitter : Mr. Philip Pan Date & Time: 12/07/2005 06:12:18
Organization : Mr. Philip Pan
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
It has long mystified me why psychotropic drugs (anti-depressants, etc.) have not been subject to the same truth-in-advertising laws and standards as are other pharmaceuticals. Now that comprehensive, scientific studies have been performed which debunk the myth of "brain chemical imbalance" (ref. http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020392), it is high time to insist that these poorly understood but broadly prescribed substances be accurately described. Misleading suppositions which easily become fact in the public's awareness must be put to an end. The consumer AND the medical profession need to know exactly what is being promoted to them. If the truth is, "It is not understood how these drugs function," then that is the message that must be communicated. Then the individual may make a well-informed decision as to whether or not to take a chance with a treatment whose outcome is at best questionable. With as much as 1-2% of the population reporting severe, psychotic, suicidal or homicidal reactions to these substances, thousands of unwitting victims have been mislead by inaccurate data and false claims, and thousands of lives have been consequently ruined. It is unethical to permit these lies to be spread and unconscionable to allow these tragedies to continue.