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 drugs—despite 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 study’s 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 house—again over his mother’s objections. Over the coming months, Dan’s mother, Mary Weiss, continued to express concerns about her son’s 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 Dan’s death. Dan’s 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/