2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC42
Submitter : Ms. Nuria O'Mahony Date & Time: 12/07/2005 06:12:46
Organization : Holistic Action Group
Category : International Consumer Group
Issue Areas/Comments
There is no scientific evidence that a brain chemical(serotonin)imbalance exists in depression, let alone that
any drug helps to 'correct' it. Stop Direct to Consumer advertising is misleading the public for corporate profit inducing harm because of unnecessary prescriptions have been issued with the adjacent dangers of adverse reactions kept hidden, especially in depression. Also all SSRIs are ineffective for most, lethal for some, HARMFUL to many and beneficial to a MINORITY. PLACEBO has been shown to be superior in many trials that have not been advertised or made public. Needs to stop. Proper warnings need to be displayed and understood by the patients. This is not happening today!!! The patients safety SHOULD be PARAMOUNT and before profits again this is not the case today.
This was not the case when my husband died from PAXIL induced suicide in 2003. Needs to change. A lot of people are dying unnecessarily from drug reactions, misinformation and corporate profits when those drugs are not even needed in the first place. Not very healthy and if continues it will destroy our society to the ground. We are rapidly going down a slippery slope. Needs to stop. Ban Direct Consumer Advertisement in the best interest of the patients and our society. At the moment this situation only benefits the corporate companies at the expense of our families health and our well-being.Drug Induced Suicides in the US for Paxil, Prozac, Zoloft( rate of 32/100K patients -minimum rate-)from 1988 to 2002 = 21900.
Drug Induced Suicides for Paxil, Prozac, Zoloft at rate of 104/100K patients (probable rate)from 1988 to 2002 = 70297.

Let's reduce these figures today!

Nuria O'Mahony
Emergency Nurse