2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
FDA Comment Number : EC6
Submitter : Mr. Charles Carpenter Date & Time: 12/05/2005 06:12:03
Organization : Mr. Charles Carpenter
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I want to thank you for the opportunity to submit comment on risk communication. It is because the FDA has failed so miserably to force public risk communication that I find myself in this situation. Yes my wife sought help for Panic Attacks and she was prescribed PAXIL.
Over the course of a few short months she went from being a very loving dedicated wife, daughter, sister and friend to a person that cared about no one or anything. She dreamed of becoming a world class photographer and was well on her way to achieving that goal when she was prescribed PAXIL. Within a few months she walked away from everyone and everything that had been important to her for many years. Yes she walked away, she had become manic and psychotic engaging in activities that were completely out of character for the person I had been married to for over 23 years. A person that hosted a weekly Bible study group for the ladies in our office building and was there to help anyone she could. That was over two years ago and she hasn?t returned to her former self yet.
We were told about dry mouth and sexual dysfunction but because the FDA has become little more than a front man for the Pharmaceutical industry the things that had the potential to destroy lives and dreams were never mentioned. Then to go a step farther the HIPAA law that was passed to protect incompetent Dr?s and the Pharmaceutical industry prevented me from speaking to her Dr about what was going on. Permission that I had been given had been was withdrawn once she became psychotic.
In an industry whose first objective is to do no harm and a regulatory agency established to protect the public from greed driven deception have both failed miserably to fulfill their respective obligations.
Is this harsh, yes it is but I believe I have the right to be harsh because not only were we misled we have been lied to.
Just to put this perspective If you use the 1% number for SSRI induced mania (which is very likely grossly low) and the numbers for individual SSRI patients in 2003 (U S only) you have enough manic people to account for every man woman and child in Louisville Ky. But this wasn?t considered significant enough that the public should be warned. Next time it could be your husband, wife, sister, brother, mother, father, grandmother, grandfather or friend. You need to take back the FDA and let the Pharmaceutical industry know by your actions that things have changed, that money will no longer buy favor and lies and deception will not be tolerated.