Dr. David Risinger — (2004 FDA Hearings)

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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.


DR. GOODMAN:  Thank you very much.