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Published online 27 November 2007 | Nature | doi:10.1038/news.2007.291
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Gene therapy trial to restart
FDA lifts ban on trial after investigating death.
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.
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Would you kindly see to it that what I write as a structure would show up as a structure? In the following, I am writing four complete and incomplete sentences in different rows using "return key" and the line break is ignored and wrapped. 1. What were the genes injected? -- and, how? -- anti-immunity measures done? 2. Causes for major internal bleeding and massive fungal infection?
It seems to me that using a broad antiinflammtory drug as one of the early tests of gene therapy may have been a bad idea, given the potential for death or serious disease as a side effect of broadly down - regulating the immune system. It also seems that testing any new drug in combination with others oof simlar function would at best mask ones ability to determine the effectiveness of said gene therapuetic. I suppose it would br informative to know how many patients on the non gene therapy drugs the deceased was taking have developed similar complicationds. To answer the above comment the gene was TNFa
The caption on the picture accompanying this artice reads: Gene therapy: a promising field that has suffered some setbacks. If one is really honest, there is no evidence whatsoever that this is a promising field and "some setbacks", refers to deaths or major complications. Can anyone tell us what is so promising about this field?