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The families of 82 patients have filed a class-action lawsuit against a major cancer center, accusing it of violating medical ethics and human research protections in a clinical trial involving recipients of bone marrow transplants. The patients participated in Protocol 126 at the Fred Hutchinson Cancer Research Center in Seattle. Lawyers for the families report that 80 of the 82 patients died from graft failures and leukemic relapse stemming from the treatment.
According to the suit filed in Kitsap County (WA) Superior Court, physicians and staff at Hutchinson Center misrepresented the risks of participating in the trial and allowed the trial to continue despite researchers’ direct financial interest in the outcome of the experiment. Genetic Systems Corp., which licensed three of the drugs being tested in Protocol 126, and its successor corporation, also were named as defendants.
The Seattle Times recently published a series of stories alleging that the Hutchinson Center neither fully warned patients of the risks and alternatives nor disclosed private financial holdings in three of the eight drugs being tested. A Hutchinson Center spokeswoman declined to comment on the pending legislation, but offered an open letter from Lee Hartwell, MD, president and director of the Hutchinson Center, and board chairman Reginald Koehler III, MD, in which they responded to the newspaper articles.
The letter describes steps being taken in response to the charges, including hiring outside experts to audit safety and data monitoring practices and patient protection procedures. Court papers say the stated goal of Protocol 126 was to prevent graft-vs.-host disease following bone marrow transplantation. The protocol involved the use of eight antibodies to kill T-cells in bone marrow donated by tissue-matched siblings.