Experts from leukemia centers defend 'Hutch'

Five researchers from major leukemia centers say a controversial medical experiment at the Fred Hutchinson Cancer Research Center 20 years ago was similar to experiments they themselves were doing at the same time.

The researchers, testifying over the past week, have said "The Hutch" met the legal "standard of care," meaning reasonable care, in its experiment, known as Protocol 126. Each of them had done similar medical experiments at the same time, with hopes of finding a way to prevent graft-versus-host disease, a serious and potentially fatal complication in bone-marrow transplants.

"They were conducting studies of reduction of graft-versus-host disease using a format, a plan, that was quite consistent with what was being done in other centers, including our own, and what was being done around the world," testified John Kersey, director of the University of Minnesota's cancer center.

Several of the experts also testified that the consent forms used by the Hutch were similar to their own at the time and adequately informed patients of the risks of Protocol 126.

The experts had done their experiments at Memorial Sloan-Kettering in New York; Dana Farber Cancer Institute in Boston; the University of California, Los Angeles; the University of Minnesota and Hammersmith Hospital in London.

The spouses of five patients who died in Protocol 126 from 1983 to 1985 are suing the Hutch, claiming the center failed to meet the standard of care and failed to inform them adequately of the risks of the experiment. The trial in a Seattle courtroom is in its eighth week.

Protocol 126 was designed to see whether depleting a type of blood cell called T-cells from bone marrow would prevent graft-versus-host disease. The method seemed to prevent more serious forms of the disease, but it increased the number of cancer relapses and fatal graft failures.

At least 83 of 85 patients enrolled in Protocol 126 died. Many researchers, including those at the Hutch, eventually abandoned the approach. However, some cancer centers, including Memorial Sloan-Kettering, continue to use T-cell depletion.

A key issue in the trial is whether the Hutch erred by enrolling patients who had as much as a 50-percent chance of a cure with a standard bone-marrow transplant in a study where the survival rates weren't known.

The defense experts disagreed with earlier expert testimony that new procedures should be tested first in the sickest patients with the least to lose.

"Those people would be predicted to die from their leukemia very quickly. And we could not evaluate the impact of the treatment on graft-versus-host disease very well," testified Richard Champlin, chairman of blood and bone-marrow transplantation at M.D. Anderson Cancer Center in Houston.

"Whereas, people in this (healthier) group of patients, actually, graft-versus-host disease is their biggest problem. So treatment to prevent graft-versus-host disease would be of most benefit to these patients."

Champlin, who was involved in T-cell depletion experiments at UCLA in the early 1980s, said researchers there enrolled the same "good-risk" patients as the Hutch. As in Protocol 126, the UCLA experiment showed a significant decrease in serious graft-versus-host disease, but that was offset by major increases in graft failures and cancer relapses.

The plaintiffs contend that the Hutch did not inform them of the higher risks of graft failure in Protocol 126, but the defense experts testified that those risks were not known.

Dr. Jane Apperley, who did T-cell depletion studies at Hammersmith Hospital, said it wasn't until late 1984 that it became apparent that graft failures were a problem. And at that point, more research was needed on any possible connection between T-cell depletion and graft failure.

The written plan for Protocol 126, submitted to the Hutch's institutional review board (IRB) before the experiment began, said T-cell depletion might increase graft failures. According to earlier testimony, two members of the review board went to the director of the Hutch in January 1984 because of concerns that two patients had already experienced graft failure. They testified that the director then promised to stop enrolling "good-risk" patients in the study; however, that did not immediately occur.

The expert witnesses said during cross-examination that they hadn't considered the actions of the review board in reaching their conclusions about Protocol 126.

"It's the IRB's job to protect patients. But one can be too conservative. You can obstruct research from going forward," Champlin testified.

David Heath: 206-464-2136 or dheath@seattletimes.com