Identity of Alleged Gene Therapy Victim Revealed

The person who died during a gene therapy trial for arthritis has been identified as Jolee Mohr, 36, of Springfield, Illinois, reports the Washington Post.

The Post is careful to point out that it's not yet certain if the death was related to the trial, but the facts are pointing straight at it.

Robb Mohr sat by his wife's hospital bed two weeks ago, trying to take it all in. His wife, Jolee Mohr, was breathing with the help of a ventilator in a Chicago intensive care unit -- her body bloated from internal bleeding, her liver failing -- and no one could figure out what was wrong with her.

Robb Mohr had his suspicions. Jolee, 36, had been feeling fine just a few weeks earlier, save for occasional stiffness from her arthritis.
Her decline had begun the day after her right knee was injected with an experimental drug made of genetically engineered viruses. Doctors at the hospital shared his concern.

Jolee Mohr died from massive bleeding and organ failure July 24....

According to the Post, the trial wasn't run well: the informed consent forms were difficult to understand, and her arthritis doctor was also responsible for recruiting her into the trial -- a clear conflict of interest.

Company officials vigorously defend the study, saying they were upfront about risks, adhered to all regulations and were terribly saddened by the loss. "We're human," said H. Stewart Parker, Targeted Genetics'
chief executive. "This is not just a patient. This is a person, and this is a horrible tragedy."

A two-sentence paragraph halfway through a 15-page consent document that Jolee Mohr signed warns of the possibility of "unknown side effects," including, "in rare circumstances, death."

Further in, after long descriptions of how the product may help, a single sentence states: "We do not expect you to receive any direct medical benefits from participation in this study."

While the link between therapy and death will probably become clear during a September meeting of the NIH's Recombinant DNA advisory committee, questions can be raised in the meantime: did Jolee Mohr understand the risks and benefits involved in the trial? Was the trial itself run carefully? Should gene therapies for non-critical diseases, such as arthritis, be conducted before a better understanding of the technique is gained through testing on people with life-threatening diseases? Might the companies financial struggles have influenced their running of the trial?

I've been working on this story. More soon.

Death Points to Risks in Research [Washington Post]

Image: Washington Post*