Investigating the fallout of a suicide - BMJ

This study was a comparison of atypical antipsychotics for the treatment of first episodes of schizophrenia (the CAFE study). 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. His mother, Mary Weiss, raised repeated concerns about his condition, questioning his involvement in the trial, but he eventually committed suicide on 7 May 2004.The fallout from this point was substantial.In 2005 the US Food and Drug Administration conducted an inspection of the Center for Drug Evaluation and Research at the university but found “no evidence of misconduct or significant violation of the protocol or regulations,”2 and in 2007 Weiss took the University of Minnesota and AstraZeneca to trial in a wrongful death case. The county court dismissed the case against the university and also the case against AstraZeneca, the trial funders, saying Weiss had failed to establish a causal link between Markingson’s suicide and the drugs.3In 2009, the Minnesota state legislature passed a new law prohibiting certain people from drug trial participation. It stated that people under state civil commitment “will be prohibited from participating in a psychiatric clinical drug t...

Source: PharmaGossip - October 9, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs