In a development eerily similar to the tragic death of
Jesse Gelsinger, the FDA released a statement late last week reporting yet another gene therapy death - this time during a clinical trial run by Seattle-based
Targeted Genetics. Broadly put,
gene therapy is a biomedical technique designed to treat diseases by replacing damaged or nonfunctioning genes with ones that work. The patients enrolled in this clinical study were testing an investigational gene therapy product designed to treat arthritis. In the course of treatment, one patient suffered a severe adverse reaction leading to the trial's suspension. The patient died a few days later.Although few other details are available at this time,
many questions are being asked such as why the FDA approved a clinical trial using a risky treatment to address a non-life threatening condition. Stay tuned to
Biopolitical Times for updates on this matter as they become available. Check out the articles at the
New York Times,
Washington Post, and
Reuters for more coverage. The FDA's statement can be found
here.