Families sue cancer center over clinical
trial
Last Updated: 2001-03-28 17:23:05 EST (Reuters Health)
By Karen Pallarito
NEW YORK (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. 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
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
experts to audit safety and data monitoring practices and patient protection
procedures.
The "purported goal" of the trial was to prevent graft-versus-host disease
(GVHD) following bone marrow transplantation, according to the complaint,
which also alleges that Genetic Systems gave Dr. E. Donnall Thomas, a
clinical director, and Dr. John A. Hansen and Dr. Paul J. Martin, principal
investigators in the study, stock and cash after submitting Protocol 126.
The protocol involved the use of eight antibodies to kill T-cells in bone
marrow donated by tissue-matched siblings, the Times reported. Researchers
thought that eradicating the T-cells would eliminate GVHD, according to the
report. Instead, with the T-cell eradication, the rate of rejection of
donated marrow and of relapse of cancer 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.
