2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC215
Submitter : Mr. Ken Kemmerer Date & Time: 12/07/2005 06:12:20
Organization : Mr. Ken Kemmerer
Category : Individual Consumer
Issue Areas/Comments
Dear Sir or Madam,
All advertising for psychiatric drugs, which says or implies that a particular drug handles a chemical imbalance in the brain, must be cancelled immediately, as it is false advertising. There is no known test which can show that a chemical imbalance exists. This was confirmed by American Psychiatric Association President, Steven Sharfstein on his TODAY show interview (27 June) when he admitted that there is no way to test for a 'chemical imbalance' as the cause for mental disorders. PEOPLE Magazine (11 July), also quoted Dr. Sharfstein as conceding, 'We do not have a clean-cut lab test.' Also, two independent medical reseachers, Jeffrey R. Lacasse and Jonathan Leo, stated, in a November 2005 paper 'In fact, there is no scientifically established ideal 'chemical balance' of serotonin, let alone an identifiable pathological imbalance. To equate the impressive recent achievements of neuroscience with support for the serotonin hypothesis is a mistake.' Therefore, in the face of such admissions, the FDA should not allow any ad which claims a drug handles a chemical imbalance in the brain, and all advertisers making such claims should be sued for false and misleading advertising.

Additionally, all radio and TV ads for drugs should be eliminated. Allowing drug companies to advertise directly to consumers was a mistake. It used to be prohibited and still should be. Consumers are not doctors and do not have the necessary information to evaluate whether a particular drug would be beneficial or harmful for them. So they should not be courted by ads intended to cause them to ask for a particular drug.