Seattle Cancer Center Faces Lawsuit
WASHINGTON-The families of participants in a blood cancer clinical trial performed at the Fred Hutchinson Cancer Research Center in Seattle, Wash. have filed a class action lawsuit alleging that the Center failed to adequately warn patients about the risks involved in the study in the 1980s and 1990s.
The class action, which was filed at the end of March, includes approximately 82 individuals, according to the complaint. As of press time, the class had yet to be certified. The lawsuit involves a clinical trial called Protocol 126 that was conducted at the center between 1981 and 1993 and was aimed at preventing an adverse reaction called graft-versus-host disease (GVHD) from occurring in patients receiving bone-marrow transplants.
According to the complaint, 80 of 82 patients have died "from graft failures and/or leukemic relapse attributable to the treatment."
"Patients who participated in this trial did so because they thought it was their best chance for success in fighting their cancer," said the plaintiff's attorney Alan Milstein, of the law firm of Sherman, Silverstein, Kohl, Rose & Podolsky. "It obviously wasn't."
The named plaintiffs are William Lee Wright, who is suing on behalf of his wife Becky who went to the center to undergo a bone marrow transplant and died following the treatment in 1985; and Peggy Draheim, whose husband Dr. John Draheim came to the center for chemotherapy, radiation and bone marrow transplants and died after a failed bone marrow transplant in 1984.
The families are suing the center and four individuals who were associated with Protocol 126. Also, the complaint lists Genetic Systems Corporation and its unknown successor company, which according to the complaint signed an agreement for commercial rights to three substances being tested in the trial.
The complaint alleges that the defendants failed to follow ethical standards, misrepresented the risks of participating in the trial, and failed to disclose their financial interests in the protocol to patients.
The center is one of the top recipients of funding from the National Cancer Institute. Both the Center and the National Cancer Institute declined to comment because the litigation is ongoing. However, the center's response to a five-part Seattle Times article earlier this year on the Protocol 126 trial is available on their Web site at www.fhcrc.org.
In an open letter to the community, patients and staff, the center responded to issues raised by The Seattle Times, in particular allegations that patients were not informed of the trestment risks in the trial.
"We at the Hutchinson center believe our system for informing patients of the risks and anticipated benefits associated with their treatment is among the best in the country," the letter said. "We also know that we carefully and effectively monitor patient safety during the conduct of clinical trials."
However, since the center believes that patient confidence may have been diminished by the series, they have taken steps to get an outside review of their practices. For example, an outside committee will review the center's practices in the area of patient protection during clinical research and at least one member of the committee will be a former patient or patient's family member.
Also, the center has asked outside experts on informed consent, protocol safety and data monitoring to audit their practices. The center plans to survey other research institutions about their conflicts of interest and financial disclosure statements in order to evaluate whether revisions are needed in their own policies.
The center also plans to make the findings of the committee and auditors available to the public. The open letter was written prior to the filing of the lawsuit.