http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4065T1.htm
DR. GOODMAN: Thank you. Speaker 46,
please.
DR. RISINGER: I am David Risinger and
this is my wife, Sarah. I have no financial ties.
Next slide. This is my 15 year-old son,
Josh.
Next five slides. All these pictures were
taken about a year ago before Josh started
antidepressants.
Next slide. See that smile? Suicidal?
No way!
Next slide. Not that he didn't have
problems. He had been seeing a psychologist who
thought an antidepressant might help.
Next slide. This is Josh before Zoloft.
He was popular, athletic, had a girl friend, was
making plans. He had hope and enjoyed life.
Next slide. Twelve tablets later he was
gone.
Next slide. Three times in those 12 days
I talked to his doctors to tell them that he wasn't
doing well; to tell them that he couldn't sleep at
all; that he seemed agitated. He cried out to us
that this medicine was making him worse. I was
told, "give it time; these take a couple of weeks
to work." Twelve days. None of us recognized the
danger he was in because none of us had adequately
been warned.
Next slide. The first I ever heard of
this controversy was this article that ran shortly
after Josh's funeral.
Next slide. There is certainly no mention
of it in any of the product literature.
Next slide. The reason I come to you
today is to caution don't rely only on the clinical
trials data to base your recommendations.
Next slide. I would like to give an
example from my practice, and that is x-ray
contrast media.
Next slide. Doctors and patients are
warned of the risks of these drugs.
Next slide. Specialized training and
preparation are required to use these drugs.
Next slide. And many lives have been
saved to reactions that never happened in any of
the clinical trials, reactions that most of my
younger colleagues have never seen and would never
believe until they saw their first case, and by
then it would be too late.
Next slide. But I know this happens. I
have seen it.
Next slide. I know this happens too. I
have seen it, and I am here to tell you.
Next slide. Don't rely only on the
clinical trial data. I think what you are looking
for maybe too rare to find there.
Next slide. But just because it is rare
doesn't mean it isn't important. There are
millions of people on these drugs. Thousands of
lives literally are at risk. What do we do? I
would like to give an example from my practice. To
interpret mammograms, every three years I have to
get 15 hours of CME. Why can't we do something
like this with these drugs? Every prescriber
should be required to periodically pass a mandatory
certification in psychopharmacology. Surely this
committee would find this tool useful for keeping
clinicians up to date, and the time is long overdue
for effective warnings on the drug label, in the
package insert, and in all advertisements. This
can't wait any longer or it will be too late.
Next three slides. For Josh and many others it is already too late. Thank you.
[Applause]
DR. GOODMAN: Thank you very much.