Originally published August 12, 2007 at 12:00 AM | Page modified August 12, 2007 at 2:17 PM
Targeted Genetics study halted following participant's death
An Illinois man wants to know exactly why his 36-year-old wife died of internal bleeding and organ failure after taking part in medical...
The Associated Press
CHICAGO — An Illinois man wants to know exactly why his 36-year-old wife died of internal bleeding and organ failure after taking part in medical research on an experimental drug she hoped would help her arthritis.
The July 24 death of Jolee Mohr of Taylorville, Ill., prompted the government to suspend a Seattle company's gene therapy study — and begin a review of the safety of 28 others around the country. Mohr, the mother of a 5-year-old daughter, received the experimental injections at a central Illinois clinic.
"Rheumatoid arthritis affected her whole body, but especially her right side," Robb Mohr told the (Bloomington) Pantagraph. His wife's death came 22 days after receiving her second injection of an experimental drug made of genetically engineered viruses.
Targeted Genetics Corp. of Seattle has halted the study, and more than 100 patients involved are being evaluated, said company spokeswoman Stacie Byars. The company believes it's too early to speculate on the woman's cause of death, Byars said.
Mohr said he believes his wife thought the drug would help her, even though the research was to determine the drug's safety, rather than its effectiveness. The University of Chicago Medical Center, where Jolee Mohr died, is conducting an investigation in an attempt to determine the cause of death.
"By the time she got to us, she was in liver failure and kidney failure, she was on a ventilator and she was septic" or responding to severe infection, hospital spokesman John Easton told The Associated Press. The hospital will send tissue samples to multiple labs for testing.
Alan Milstein, a New Jersey attorney who is representing Robb Mohr in a possible lawsuit, said Jolee Mohr believed the experimental therapy would be in her best interests.
"She wasn't going to risk her life for science or medicine or the profits of some company," Milstein said on Saturday. "She had mild rheumatoid arthritis."
Milstein also represented 18-year-old Jesse Gelsinger, who died in 1999 in his fourth day of a gene therapy experiment at the University of Pennsylvania. Gelsinger had suffered from an inherited disorder that blocks the body from properly processing nitrogen. The Food and Drug Administration concluded that the gene therapy injection intended to try to cure him instead killed him.
Milstein said he's not sure who's to blame for Jolee Mohr's death, but "we certainly believe the death was connected to the research trial she was in."
Twenty-eight other gene therapy studies have been reported to the FDA that used, or are using, the same virus, called adeno-associated virus or AAV.
The therapy uses AAV to deliver a gene that in turn blocks tumor necrosis factor, a substance that fuels the joint inflammation behind crippling forms of arthritis. Drugs that block TNF already are widely used to treat rheumatoid arthritis and other conditions, but a gene therapy approach is new.
The FDA has said that it was not aware of any serious side effects in any of the AAV studies but that as a precaution, officials are reviewing the ones still actively treating patients.
In addition, the National Institutes of Health's advisory committee on gene therapy will meet in September to discuss the potential scientific implications of Mohr's death.
Copyright © 2007 The Seattle Times Company
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