Dennis Winter — (2004 FDA HEARINGS)

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(2004 FDA PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE WITH THE PEDIATRIC SUBCOMMITTEE OF THE ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE)

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.