CGS-authored

http://sfgate.com/cgi-bin/article.cgi?file=/c/a/2007/09/13/ED1OS4UGS.DTL

Later this month, a committee of the National Institutes of Health will discuss the recent death of 36-year-old Illinois resident Jolee Mohr in an experimental gene therapy study sponsored by Targeted Genetics Corporation. The NIH committee is an advisory body only, but its meeting may provide Mohr's family - and the rest of us - a rare glimpse into the inner workings of the clinical trial enterprise in the United States.

Real regulatory and oversight authority for gene therapy and other clinical trials rests with the Food and Drug Administration. The FDA conducts much of its work behind closed doors in order to protect the proprietary interests of the studies' sponsors. The unfortunate result is a deficit of transparency and accountability, and an unknowable amount of dirty linen hidden away.

The FDA is investigating Mohr's death, and hasn't yet announced whether it will be attributed to the gene transfer. But Mohr died following a fever of 105 degrees and multiple organ failure, symptoms that began to develop just after she was injected with the genes carried by engineered viruses.

Gene...

Human Genetic Modification