Monday, December 17, 2007
BLOGSCAN - More About Methodologic Flaws in Targeted Genetics Trial
We have posted a few times about an ill-fated trial of a gene therapy treatment. To summarize the case thus far, a young woman received a dose of an adeno-associated virus carrying a gene that was meant to have a local immune suppression effect, tgAAC94, made by Targeted Genetics, directly into her joint as part of a phase I study meant to assess the safety of the treatment. Soon after the treatment, she became ill, then very ill, and ultimately died in an intensive care unit. Although many flaws in the trial were identified in retrospect, and although there was no proof one way or the other whether the treatment was related to the patient's death, the trial was just allowed to resume (see most recent post here). This post by Dr Chris Evans on the Bioethics Forum identifies yet more methodologic problems with the trial, further challenging the wisdom of resuming it without substantial modifications.