Summary:

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

             DR. RUDORFER:  Number 37, please.

                           Marion Goff

             MS. GOFF:  I do not have any financial

   ties.  I am her with my daughter, Alex.  We are


   here to tell you about her twin sister, Devon, when

   she was 9 years old.  We are also joined by Senator

   Lincoln Chafee's wife Stephanie who is a friend of

   ours.

             In 2002, Devon developed an

   obsessive-compulsive disorder very suddenly and

   very severely.  In a three-month period, she lost

   10 pounds.  We consulted a specialist who

   prescribed Zoloft on her second visit with him.

   Soon thereafter, he increased the Zoloft to 50

   milligrams or more, but it didn't help, so he

   changed her prescription to Paxil.

             She was hospitalized and Devon's medical

   condition was compromised in that she had developed

   a cardiac arrhythmia and had to be placed on a

   heart monitor.  She was in the hospital for one

   month, and she was on the heart monitor and bed

   rest for the entire time.

              During this time, her Paxil was increased

   to 20 milligrams.  A few days later she was started

   on Zyprexa also.  Devon was not getting any better,

   in fact, her behaviors grew worse.  She began

   hitting her head against the metal hospital bed.

   She threatened to jump out of the window on two

   occasions.
             On two other occasions, we found a pair of

   sharp scissors in her bed.  Our child was never

   suicidal before these medications.  At one point,

   my 9-year-old child, who weighed little more than

   60 pounds, was on 30 milligrams of Paxil and 10

   milligrams of Zyprexa.

             Our gentle daughter would now fly into a

   rage several times each day.  It became part of our

   life to have my husband and myself restrain Devon

   at times for fear that she would truly hurt

   herself.

             During these times, she would try to

   inflict injury upon herself by banging her head on

   walls, beds, floors.  She would punch herself in

   the legs and arms.  She grew extremely violent

   toward us.  She would run to the silverware drawer

   and get a knife and attempt to stab herself.

             The worst moment happened when I looked in

   on her, in her room one night, to find her by her

   open second floor bedroom window with one leg out

   the window in a position as if she appeared she

   would jump.

             Devon is presently being treated for Lyme

   Disease.  In summary, our experience has been one

   of absolute terror to watch your 9-year-old
   daughter suffer so much, so suddenly, and to be so

   lost in helping her.


             So often we would ask why this was

  happening, and we were told to forget about the

  etiology.

             DR. RUDORFER:  I am sorry, we are out of

   time. Thank you very much.