Biotech co. defends gene therapy trial standards

The death of Jolee Mohr in a gene therapy trial undertaken by Seattle-based Targeted Genetics has once again thrown a spotlight on the safety record of the whole gene therapy field. The family wants to know why she was recruited for a study that offered her next to no chance of a medical benefit. The 15-page consent agreement is also being scrutinized, as the company insists that it did nothing improper in pursuing testing of tgAAC94, which uses a specially engineered virus to transport a gene. When working properly, the therapy produces proteins that eliminate the inflammatory molecules that cause arthritis. But now questions are being raised about breaches in the consent process as the family finds out that the consent agreement was signed on first sight--rather than studied--and that the principal investigator suggested she volunteer rather than having someone else make the proposal. It all represents another huge setback for gene therapy, which has been periodically roiled over the years by the unexpected deaths of trial participants.

- here's the report from The Washington Post

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