Violence & Suicidal Thoughts Paxil 01/02/2004 Maryland Man Has Severe Reaction to Paxil
Summary:
http://www.fda.gov/ohrms/dockets/AC/04/transcripts/4006T1.doc
If we could have speaker 28, please.
Matthew Piepenburg
MR. PIEPENBURG: Well, there are very
impressive credentials around this room and
certainly at this panel, and impressive schools and
qualifications and professorial positions at very
elite institutions.
There are also a number of impressive
terms of art tossed around - morbidity,
idiosyncratic. I like Mr. Katz's term controlled
data or controlled trial data.
What I would like to suggest is behind me
is a number of things that do not show up in
controlled trial data that need to be heard, that
are as important as what can be achieved
statistically.
I don't think for parents who spend a
great deal of time in cemeteries, controlled trial
data is as pervasive or persuasive.
I do not suggest or believe that everyone
here has a negative or a grotesque motive or is all
greedy. I do think there are legitimate motives
here, and I think these things do need to be
discussed without being incendiary.
Nevertheless, it is important to recognize
the human dimension here. We had prepared a
two-page speech full of FDA talk papers, adverse
reporting events on Paxil in particular, my family
friend, Paul Domb, has suffered as a victim of
Paxil. It is just very hard to go over that when
you hear these stories.
Last night, we were at a restaurant. We
gave the waiter our speech to print out for us off
of a disk. He came back. He had suffered Paxil
side effects that led to suicidal thoughts, violent
thoughts after a 40-year marriage, and he saw our
speech and sat down for 20 minutes and basically
cried before us.
It is a pattern and epidemic that is
pervasive and has more importance to me than the
statistics we were going to read. Let me just
suggest also that this individual had been to
Vietnam, lost most of his platoon and most of his
body in Vietnam, crawled for two and a half days
through the jungle to survive.
None of that caused him the depression or
the desire to jump off a bridge like Paxil did. If
he could handle Vietnam with poise, how are 13- and
12-year-old kids supposed to handle Paxil?
Thank you very much.