Matthew Piepenburg — (2006 FDA Hearings)

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DR. RUDORFER: 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.