Suicide Paxil 05/12/2003 Rhode Island 22 Year Old Woman Kills Self
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.