'Hutch' experiment's risks were known, expert testifies

The risks of dying from an experimental form of bone-marrow transplant were well-known before the Fred Hutchinson Cancer Research Center began Protocol 126, according to expert testimony yesterday.

Dr. Robert Gale, who did similar research at the University of California, Los Angeles, said patients should have been told they had a greater chance of dying from graft failure or cancer relapses from the experimental procedure.

"Those elements were crystal clear," Gale said on the last day of testimony in a trial of a lawsuit against "The Hutch" and three of its doctors. The spouses of five patients who died in Protocol 126 from 1983 to 1985 are suing, claiming they were not told of all the risks.

Gale's testimony contradicted testimony from Paul Martin and John Hansen, two of the defendants who are also colleagues and friends of Gale's. Martin and Hansen said they did not expect a type of graft failure known as graft rejection would be a problem before the experiment began.

"It doesn't sound like something Paul Martin would say," Gale testified. "He's a very thoughtful and careful investigator."

Protocol 126 was designed in the hopes of preventing graft-versus-host disease, a potentially fatal complication of bone-marrow transplants. It used a new technique of depleting a type of blood cells called T-cells from the donor marrow before transplantation. Gale said there was so much scientific data on T-cell depletion that researchers knew before testing it in humans it would reduce graft-versus-host disease, but they also knew it would increase cancer relapses and graft failures.

Depleting T-cells was worth trying because it might lead to fewer deaths overall, Gale said, but patients had to be told of the risks. He said the consent forms used in Protocol 126 did not do that. "In my opinion, that does not convey the substantial risk of death," Gale said, referring to the consent form. "(It) very likely would not have passed muster with the IRB (institutional review board) at UCLA."

Institutional review boards are responsible for protecting patients, and all experiments are subject to such panels' approval. Gale later said he was speculating about what the UCLA review board might have done. Copies of the consent form used at UCLA can't be found, but Gale said he would be embarrassed if it didn't spell out the risks of death.

Closing arguments in the eight-week trial are scheduled today.

David Heath: 206-464-2136