Summary:


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.