2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC61
Submitter : Ms. Krista Erickson Date & Time: 12/07/2005 06:12:03
Organization : MindFreedom International
Category : International Organization
Issue Areas/Comments
Current advertising for drugs, especially many psychiatric drugs, is misleading at best. Many ads for antidepressant drugs, such as Zoloft and Prozac, claim that the drug(s) correct chemical imbalances in the brain. There is currently, however, no scientific evidence to support this assertion. The FDA is doing a great and dangerous diservice to millions of people by not regulating ads for psychiatric drugs. Drug ads should not be permitted to market products to consumers based on myths -- in this case that drugs such as Zoloft and Prozac may correct a chemical imbalance in the brain. There is no evidence that these drugs do any such thing. The American Psychiatric Association has admitted on at least three occasions that there is no certain biological basis/cause for conditions that are classified as "mental illness." MindFreedom's website also has a series of letters that we exchanged with Pfizer in which Pfizer's representative is hard-presssed to provide a reference for the chemical imbalance theory of "mental illness." Consumers should know that the chemical imbalance theory is nothing more than a myth and that psychiatric drugs have serious (even deadly) side effects. Many other nations have taken steps to regulate psychiatric drugs and the FDA needs to do likewise. Thank you.