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August 13, 2007 at 10:00 AM

Questioning the ethics in Targeted Genetics clinical trial

The tragic death of 36-year-old Illinois woman Jolee Mohr during a Targeted Genetics clinical trial has raised a dust-up over whether the enrollment of patients in such experiments is being handled ethically.

A Washington Post story published last week says there were “failures in the safety net that is supposed to protect people from the risks of medical experimentation.”

The Post report said rules were breached when when Jolee Mohr’s own doctor — an investigator in the Targeted Genetics clinical trial — prompted her to enroll in the experiment. If a patient’s own doctor is involved in the research, “someone else is supposed to make the proposal,” the story says. Another breach occurred when Mohr didn’t take consent forms home before signing them, according to experts cited by the newspaper.

But a story today in The Chronicle of Higher Education says that “neither standard mentioned in the Post article was a true rule in clinical research.”

Bioethicists cited in the story agreed with the Post in that it would be “good practice” not to allow treating doctors who are also researchers to enroll their own patients in their experimental studies. But University of Pennsylvania medical ethics professor Jonathan Moreno said such enrollments were “quite common.”

In the story, a Northwestern University researcher involved in the Targeted Genetics trial said that patients who participate “always have an opportunity” to take the consent form home and read it, “but by no means do we [require[ people to come in and then go home and then come back again.”

Mohr’s death — which came shortly after the injection of a second dose of Targeted Genetics’ experimental arthritis drug — cast a grim light on gene therapy, a field that is considered promising but has so far yielded little result. It also echoed another death associated with gene therapy — the 1999 demise of Jesse Gelsinger, a patient at a University of Pennsylvania experiment.

Gene therapy seeks to cure disease by transforming certain genes. But the adenovirus vector chosen to replace some of Gelsinger’s defective genes with new ones triggered a massive reaction that killed him.

The therapy Mohr was getting used a different kind of vector than in the Gelsinger trial — an adeno-associated virus — that many experts thought safe. The cause of death hasn’t been determined yet.

Targeted Genetics defends handling of fatal test case

Targeted Genetics drug puts clinical trials in spotlight

Death clouds a gene-therapy’s future

Patient in Targeted Genetics arthritis-drug trial dies

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