2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC10
Submitter : Mr. David Oaks Date & Time: 11/18/2005 02:11:33
Organization : MindFreedom International
Category : International Organization
Issue Areas/Comments
GENERAL
GENERAL
Docket: 2005N-0354 - Consumer Directed Promotion of Regulated Medical Products; Public Hearing

Dear FDA:

Our non-profit organization unites 100 groups with many members to speak out for human rights of people affected by the mental health system.

This letter is to specifically complain about inaccurate advertising for prescribed psychiatric drugs that fraudulently claims to help correct a 'chemical imbalance.'

We call for an immediate halt to all ads that make this false claim.

First, there is no citation to any peer reviewed scientific evidence validating the claim that any psychiatric drug corrects any chemical imbalance.

Second, there is no citation to any peer reviewed scientific evidence validating the claim that there is such a chemical imbalance in the first place!

Third, there is no citation to any peer reviewed scientific evidence showing us what a 'balanced' chemical level ought to be in the brain.

On our behalf, Senator Ron Wyden wrote to the FDA to inquire about the validity of these ads. In their response, the FDA was unable to cite even one scientific article or piece of research to validate the 'chemical imbalance' claim. Instead, the response the FDA merely cited the previously- approved product description by the manufacturer itself; of course, this product description had no scientific evidence or citations to research to validate the 'chemical imbalance' claim either.

There is a recently published essay in a peer reviewed scientific journal that carefully examines the 'chemical imbalance' claims of these psychiatric drug ads, and shows they are false.

The citation for the essay is here, AND THE ESSAY IS ATTACHED AS A PDF.

Lacasse JR, Leo J (2005)
Serotonin and depression: A
disconnect between the advertisements
and the scientific literature. PLoS
Med 2(12): e392.

The best of theoretical neuroscience today is discovering how little we know about the mind. If anything themind is an emergent phenomenon, and
reductionist mechanistic metaphors about chemical imbalances are outdated, unscientific and unproven. If anything, science is discovering neurochemistry must exist on the edge between balance and imbalance for live to even exist.

We would like the FDA to consider evidence from the following web pages about this subject


See an article in MEDSCAPE about this issue here:

http://www.intenex.net/pipermail/mindfreedom-news/2005-November/000015.html

or use the smaller url:

http://tinyurl.com/8s5e2

See our alert about the

http://www.intenex.net/pipermail/mindfreedom-news/2005-November/000014.html

or use this smaller url:

http://tinyurl.com/cbzzu

THE FULL TEXT OF PLoS ESSAY:

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020392

or use this smaller url:

http://tinyurl.com/8vywy

PRINT PDF (205 K) VERSION OF PLoS ESSAY:

http://medicine.plosjournals.org/archive/1549-1676/2/12/pdf/10.1371_journal.pmed.0020392-p-L.pdf

or use this smaller url:

http://tinyurl.com/bcwf3

Sincerely,


David Oaks, Director
MindFreedom International
454 Willamette, Suite 216 - POB 11284
Eugene, OR 97440-3484 USA

http://www.mindfreedom.org
email: oaks@mindfreedom.org
office phone: (541) 345-9106 fax: (541) 345-3737
toll free in USA: 1-877-MAD-PRIDE or 1-877-623-7743

United Action for Human Rights in Mental Health.

join here: http://www.mindfreedom.org/join.shtml

MindFreedom International is an independent
non-profit uniting 100 sponsor groups
to win human rights & alternatives in mental health.
Accredited by the United Nations as a
Non-Governmental Organization (NGO) with
Consultative Roster Status.


2005N-0354-EC10-Attach-1.PDF