Summary:

http://www.fda.gov/ohrms/dockets/AC/04/transcripts/4006T1.doc

If we could have speaker 48, please.

                           Dennis Winter

             MR. WINTER:  I am Dennis Winter.  I am

   here today with Karine Winter and Mary Lou Winter,

   Beth's mom.

             Four months ago or less than four months

   ago, Beth, a 22-year-old recent graduate from the

   University of Rhode Island, she graduated summa cum

   laude, she was a child who was loving, from a very

   tight, close family, never any instance of alcohol

   or drug abuse, never any problems, a wonderful

   student, a wonderful girl, a loving sister to her

   brothers and sisters, committed suicide after being

   on Paxil for seven days.

             Now, what I think is critical here is the

   fact that she can go to her general practitioner on

   the first visit and be prescribed Paxil.  I think

   it is clear that you need to come out with warning
   labels for practitioners and doctors, so the

   lawyers in this room, when those labels are out

   there, if the doctors continue to do it, will be

   able to bring actions.  If you bring out the

   warning labels, there is enough legal community in

   this world that will police itself.

             Let me go on.  As we are sitting here

   today, we heard a lot about idiosyncratic data, all

   permitted data, requested data available, data we

   are permitted to evaluate fully, and it comes down

   to this data stream that we don't know that

   happened 15, 20 years ago, the data stream you are

   trying to analyze.

             I don't know, like Mr. Farber said, if you

   are going to be analyze all that data and come out

   with that data.  You should put out warning labels

   because you are not going to get a clear answer.

             I am running out of time, but Dr. Healy

   provided testimony in federal court on May 22nd,

   2001.  Everybody needs to be read that testimony.

   He gave it under oath, under threat of perjury, and

   that is very enlightening to anybody involved here,

   and you really need to read it.

             Also, you need to look at confidentiality

   agreements.  A lot of families of people who commit

   suicide are embarrassed.  When the lawyers come,

   they sign confidentiality agreements, and you don't

   hear about what is really happening out there.

             DR. RUDORFER:  Thank you very much.