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Gene Therapy Trial Halted After Death, FDA Investigates

July 30, 2007

Brandon Keim

A gene therapy that may have killed a clinical trial participant last week drew the concern of an expert review panel four years ago, reports the Washington Post.

The latest trial, sponsored by Seattle's Targeted Genetics, was designed to test a treatment for inflammatory arthritis. The people involved had a virus injected directly into their joints, where it delivered genes that blocked the production of tumor necrosis factor, the substance underlying the most crippling forms of arthritis.

In 2003, NIH reviewers asked the company why "such a novel and possibly risky approach was to be offered to patients who were not especially ill, including some who had not even tried standard treatments.

They also pointed out that animal studies had shown a limited benefit, that the therapy's risks hadn't been adequately documented, and that the company hadn't clearly told patients "that the study was unlikely to help them and was designed merely to test the new approach's safety." The company reportedly remedied these flaws, and the trial went ahead on 32 people, none of whom suffered serious side effects. The recent trial involved 100 people, one of whom became ill and died. Details about the death are unavailable at this time. It is possible that the death was coincidental.

According to the Associated Press, 28 other ongoing gene therapy trials involve the same virus, called adeno-associated virus or AAV. The FDA shut down the Targeted Genetics trial and is reviewing the others.

At this point, it's too soon to jump to conclusions about the therapy or the death. More on the facts as they become clear. There are, however, some broad lessons to be drawn -- foremost among them that, at this point, gene therapy should only be used to treat critical conditions, and shouldn't be tested in people when it doesn't help animals.

Last week we posted on what individuals should think about when considering taking part in a gene therapy trial. Please share this with anyone you know who could use it.

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