Summary:

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4272t1-part1.pdf

The next speaker is Jayne Richner.
9 MS. RICHNER: On August 16, 120 days ago
10 today, our lives were shattered beyond any words I
11 can express to you today
. Our beloved 22-year-old
12 son, Sean, was horrifically killed and we were
13 brutally robbed. Sean had no history of
14 depression. He had visited his primary care doctor
15 just for general situational anxiety in which he
16 was given a 90-day prescription of Celexa in a
17 10-minute office visit.
18 After being on these for approximately
19 two and a half months, he could no longer sleep.
20 His mind kept racing and thinking all the time,
21 among other effects.
22 He went to his doctor, as a result of
0228
1 these feelings, four weeks prior to this death.
2 His doctor recommended no further medication and
3 said these are side-effects and they should resolve
4 themselves in three to four weeks.
5 We and Sean trusted that the FDA and the
6 doctors are educated and well-informed about these
7 drugs and the risks and dangers in order to be able
8 to prescribe these. We now know how wrong we were.
9 Without a doubt, we stand before you
10 today knowing Sean was a victim of the withdrawal
11 effects of discontinuing the antidepressant,
12 Celexa, suicide by hanging in the middle of the
13 night in our home.
14 At only 22 Sean had the world in his
15 palms of his hands. He worked for almost two years
16 in a high-tech company, my company. He has his car
17 and his dream bike paid for.
18 He was pursuing a career as a
19 firefighter. He was enrolled in an EMT paramedic
20 program and was in the top of his class with one
21 month left to go. The state trooper teaching his
22 class is devastated by this and has awarded Sean
0229
1 all of his certificates.
2 Sean was also in training with the local
3 auxiliary fire department and had just received his
4 protective gear, which he proudly wore. He had
5 taken the Firefighter Civil Service Exam in June.
6 We just received his score result of 91 last month.
7 Sean would have been excited and proud, although he
8 knew he aced it when he took it.
9 Sean had it all going for him and he knew
10 it. He was excited that he had a direction, and
11 that it was all falling into place. He was
12 articulate. He was outgoing and social with a
13 sense of humor and a smile that drew everybody to
14 him. He was athletic, played the guitar, and
15 sang.
16 He openly loved his family, his future,
17 and his friends -- who are all as devastated as we
18 are knowing this is incomprehensible. Sean loved
19 life.
20 Sean did not choose to end his life.
21 That was done for him by the drug-induced fatal
22 withdrawal effects of the antidepressant that he
0230
1 was prescribed.
2 A few nights prior to his death he
3 appeared to be disconnected and then could be in
4 and out of altered states. He jumped out of a
5 second-story bedroom window and then requested that
6 a friend stay over with him.
7 He was extremely restless and agitated as
8 he slept and then awoke during the night and had to
9 keep moving around. No one knew what was wrong.
10 We now know this is referred to as akathisia. He
11 was found kneeling at his bed with his hands
12 clenched over his head.
13 When we found him, his feet were touching
14 the floor. We can't imagine the psychotic state he
15 must have been in. Without a doubt, Sean had no
16 control over this and was overtaken by these drugs.
17 (Applause.)
18 DR. PINE: Thank you.
19 The next speaker is Nancy Sharby.
20 MS. SHARBY: Good morning. Thank you for
21 allowing me to come. I am truly moved and very
22 saddened by the story of the woman and the family
0231
1 who spoke before me, but I have a very different
2 story.
3 I come here today from Boston,
4 Massachusetts, but I really come from a farther
5 place than that. I come from a place that has a
6 long legacy of mental illness and suicidality.
7 In 1915, my great-grandfather walked into
8 his kitchen, and while his family was eating
9 dinner, he drank a bottle of lye. My grandmother's
10 brother committed suicide; my grandmother attempted
11 suicide; and my mother was suicidal. For all of
12 them, there was no effective intervention nor
13 effective treatment, but we are different.
14 I have two children with bipolar
15 disorder, and I have depression myself. My
16 daughter was diagnosed at 17, although she was sick
17 for many years before that. My son was diagnosed
18 at 19.
19 Both of them have told me that if it were
20 not for my efforts of extensive advocacy and
21 intervention for them, they would not be alive
22 today.
0232
1 My daughter has told me she is eternally
2 grateful for interventions on her behalf, even
3 though there were times when she looked at me and
4 told me how much she hated me for dragging her to
5 all of her clinicians.
6 Both of them have been hospitalized on
7 numerous occasions as we attempted to stop their
8 downward spiral into self-destruction. We are
9 extremely fortunate that we have fabulous
10 clinicians who are able to work with them and to
11 prescribe effective psychotropic medications.
12 The only reason they are alive and
13 thriving today is because of the integrated effects
14 of family collaboration, my children's
15 collaboration, and effective care by their care
16 providers.
17 I can speak personally of the effects of
18 depression on myself. It is not a matter of being
19 sad or unhappy or sometimes feeling unmotivated.
20 Depression takes you to another altered state where
21 you aren't able to think, to remember, to make good
22 decisions, or to express any joy in life. There is
0233
1 no hope that tomorrow will be any better than
2 today. It disorganizes your brain.
3 Clearly, depression has a high personal
4 cost, but it also has a high cost to society as
5 well. As I mentioned before, there was high loss
6 of work or productivity, there was decreased
7 ability on disability claims, high health insurance
8 costs, and traumatically shattered families.
9 The good news is that depression is a
10 treatable disorder, and there are many effective
11 treatments available. However, no medication is
12 effective for every person, and each medication is
13 to be carefully calibrated to meet the exact needs
14 of the individual who gets them.
15 I have to say in my family we have
16 definitely needed to adjust medications. It can
17 only happen when treatment is effectively monitored
18 by the family, the care provider, and the patient
19 alike.
20 Please do not set any barriers in place
21 for effective treatment of patients who can benefit
22 from drug rehabilitation.
0234
1 Thank you.
2 DR. PINE: Thank you.