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By Karen Pallarito
NEW YORK, Mar 28 (Reuters Health) - A major cancer center has been accused of flouting medical ethics and human research protections in a clinical trial involving recipients of bone marrow transplants.
A class-action lawsuit was filed Monday on behalf of the families of 82 patients who participated in "Protocol 126" at the Fred Hutchinson Cancer Research Center in Seattle, Washington. Eighty of the 82 patients are dead from graft failures and leukemic relapse stemming from the treatment, according to the complaint.
The suit filed in Kitsap County Superior Court charges Hutchinson Center and several center officials with misrepresenting the risks of participating in the trial and allowing 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 lawsuit follows a Seattle Times series published earlier this month that reported 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.
Hutchinson Center spokeswoman Susan Edmonds told Reuters Health that the cancer center does not comment on pending litigation. But the center's Web site features an "open letter" from Dr. Lee Hartwell, president and director of the Hutchinson Center, and board chairman Reginald S. Koehler III, responding to the Seattle Times series.
While disputing the Times' portrayal, the letter outlines several steps being taken to restore patients' confidence, including hiring outside auditors to evaluate protocol safety, data monitoring and patient protection practices.
The "purported goal" of the experiment was to prevent graft-versus-host disease, an immune-system reaction associated with bone marrow transplantation.
But instead of helping cancer patients, the experiment allegedly enriched the investigators involved in the trial. According to the complaint, Genetic Systems gave Dr. E. Donnall Thomas, a clinical director, and Drs. John A. Hansen and Paul J. Martin, principal investigators in the study, stock and cash after submitting Protocol 126.
The experiment used eight antibodies to kill white-blood T-cells in bone marrow donated by tissue-matched siblings, the Times reported.
Researchers thought that eradicating the T-cells would prevent rejection of the transplant, according to the report. But with the T-cell eradication, the rate of rejection of donated marrow and of relapse of cancer actually increased dramatically, it said.
"There was accepted therapy for these patients that would have given them anywhere from a 20% to 50% chance of survival, and of course 80 of the 82 patients who were enrolled in this clinical trial died, and died quickly and painfully," lead attorney Alan C. Milstein told Reuters Health.
Milstein, with the Pennsauken, New Jersey, office of Sherman, Silverstein, Kohl, Rose & Podolsky, represented the family of Jesse Gelsinger, who died in 1999 following an experimental gene therapy treatment at the University of Pennsylvania. Gelsinger's family settled the lawsuit out of court.
He also represents cancer patients who participated in a melanoma vaccine clinical trial at the University of Oklahoma Health Sciences Center at Tulsa (see Reuters Health report, February 2).
"The three cases are similar because they all involve clinical trials and the ethical issues surrounding clinical trials," Milstein said. "It's very similar to the Gelsinger case in that you have a biologic involved and you also have the issues of conflict of interest."
The Hutchinson case is troubling, he explained, because cancer patients are "very vulnerable" and "willing to do anything to get cured."
"Whatever the doctor says to them, however he explains the risks...the patient is going to think that the doctor has the patient's best interest at heart," he said.
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