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.