A court case involving one of America's leading medical research centres has opened up a discussion of the limits of informed consent. The Fred Hutchinson Cancer Research Center in Seattle and three of its researchers are disputing allegations that they misled participants in an experiment which ran from 1983 to 1991. The defendants include Dr E. Donnall Thomas, who won the 1990 Nobel Prize for his pioneering work in bone marrow transplants.
At the heart of the complex case is whether the patients understood what they had agreed to. "The Hutch", as it is known in Seattle, has denied that any of the 85 patients enrolled in the experiment, called Protocol 126, was misled or that information was withheld from them. At least 83 of the 85 patients died when the novel transplant method failed. The spouses of five of the patients are now suing the Center.
Although a number of expert witnesses will be testifying that Protocol 126 was ethical, the lead researcher Dr Paul Martin, acknowledges that "patients were not told about the experiment until a meeting with doctors hours before treatment was to begin," according to the Seattle Times. Some of the participants had a disease with at least 50% chance of survival with a conventional transplant, but nearly all died after Protocol 126.
Claims of financial conflict of interest -- Dr Thomas, Dr Martin and another researcher owned shares in a biotech company at the same time as they were testing the company's antibodies in Protocol 126 - - were thrown out by the trial judge. He said that there was not enough evidence that the research would have led to a useful product.
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