The mysterious death of an Illinois woman in a gene therapy clinical trial has raised questions about informed consent and the future of novel therapies like embryonic stem cells. Jolee Mohr was a 36-year- old mother who suffered from rheumatoid arthritis. Her symptoms were already being managed with a new anti-inflammatory drug, but her doctor signed her up for an experiment run by a Seattle biotech, Targeted Genetics. Three weeks after an injection of genetically altered viruses, she was dead.

There has been no convincing evidence so far that her death was caused by the gene treatment, but the news is disquieting for potential investors in gene therapy. The final results of an autopsy are expected in December.

In the meantime, there has been much discussion of the informed consent process. Mrs Mohr was recruited by her doctor, but she was not told that he was being paid for every patient he signed up. He also secured her consent on the spot, rather than letting her study the 15-page form at home. Recruitment by doctors has always been a controversial practice, because patients routinely believe that experimental treatments recommended by their own doctor are likely to help them.

Bioethicist Arthur Caplan, of the University of Pennsylvania, says that the tragedy underscores the high risk of participating in clinical trials for novel therapies. He suggests that there should be a national insurance program for people injured in early-stage research studies, so that their bereaved families do not have to engage in lengthy litigation to pay their bills. He also questions whether there is enough protection for patients when drug companies are sponsoring much of the research, when for-profit ethics committees are reviewing trials, and when doctors are paid for recruiting patients.

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Michael Cook

Michael Cook edits BioEdge, a bioethics newsletter, and MercatorNet, an on-line magazine whose focus is human dignity. He writes from Sydney, Australia.

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