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FDA lifts ban on trial after investigating death

Posted on: 27 November 2007, source: Nature News
A clinical trial of gene therapy in which a woman died this summer is due to recommence, thanks to a decision from the US Food and Drug Administration (FDA) announced yesterday. The experimental therapy for rheumatoid arthritis was stopped after one of the participants, 36-year-old Jolee Mohr, died in July. Autopsy findings presented in September showed that Mohr died of a massive fungal infection complicated by major internal bleeding, and that the gene therapy itself may not have been to blame (see: Study Clears Gene Therapy in Death of Arthritis Patient). Independently of the gene therapy, Mohr was taking several drugs for her arthritis that suppress the immune system, which is a risk factor for this type of infection.