A Clinical Trial and Suicide Leave Many Questions
By Judy Stone |
The suicide of Dan Markingson, a 26 year old man participating in a psychiatric trial, has again made the news, and will serve us for a life-time of study and discussion of research ethics, along with the TeGenero and Jesse Gelsinger cases.
Markingson began to show signs of paranoia and delusions in 2003, believing that he needed to murder his mother. He was committed to Fairview Hospital involuntarily after being evaluated by Dr. Stephen Olson, of the University of Minnesota. He was subsequently enrolled on a clinical trial of antipsychotic drugsdespite protests from his mother. This study was a comparison of atypical antipsychotics for the treatment of first episodes of schizophrenia (aka the CAFÉ study), sponsored by AstraZeneca. The studys structure was that of a Phase 4 randomized, double-blind trial comparing the effectiveness of three different atypical antipsychotic drugs: Zyprexa (olanzapine), Risperdal (risperidone) and Seroquel (quetiapine), with each patient to be treated for a year.
After about two weeks on study treatment in the hospital, Markingson was discharged to a halfway houseagain over his mothers objections. Over the coming months, Dans mother, Mary Weiss, continued to express concerns about her sons deterioration, even asking if her son might have to kill himself before anyone else would take notice
then, in fact, her son violently committed suicide on May 7, 2004, mutilating himself with a box cutter.
The University of Minnesota and their IRB have maintained that the study was conducted appropriately and that they have no responsibility for Dans death. Dans mother and bioethicist Carl Elliott believe otherwise. Elliott has written passionately about the case regularly, with major articles being here and here.
more
http://blogs.scientificamerican.com/molecules-to-medicine/2012/12/11/a-clinical-trial-and-suicide-leave-many-questions-part-1-consent/
part 2
http://blogs.scientificamerican.com/molecules-to-medicine/2012/12/13/a-clinical-trial-and-suicide-leave-many-questions-part-2-investigator-responsibilities/
part 3
http://blogs.scientificamerican.com/molecules-to-medicine/2012/12/18/a-clinical-trial-and-suicide-leave-many-questions-part-3-conflict-of-interest/