Protocol showed great promise, Hutch Center researcher testifies

The researcher who proposed Protocol 126, a controversial medical trial at the Fred Hutchinson Cancer Research Center, said he thought at the time that the experiment offered great benefits and minimal risks to patients.

Dr. John Hansen of "The Hutch" testified that he and others delayed the experiment for two years while doing tests to make sure it was safe.

"The intrinsic risk that we identified for this approach was minimal," Hansen said in testimony that spanned three days.

As it turned out, the experiment had one of the worst death rates of any done at The Hutch, with at least 83 of 85 patients dying between 1981 and 1993. Researchers discovered that the bone-marrow-transplant process used in Protocol 126 increased fatal graft failures and cancer relapses.

Hansen's testimony concluded yesterday as the trial of a lawsuit against The Hutch entered its seventh week. The spouses of five patients who died in Protocol 126 filed the suit, claiming The Hutch didn't fully inform them of the risks of the experiment.

Protocol 126 used a process to deplete a type of white blood cell called T-cells from marrow before transplanting it into leukemia patients. Researchers hoped the process would prevent graft-versus-host disease, a serious and potentially fatal complication of bone-marrow transplants.

However, some researchers at The Hutch expressed concern before the experiment began that depleting T-cells might cause fatal graft failures. The center's review board initially rejected the experiment, also citing concerns that it might increase graft failures and cancer relapses.

Hansen modified the experiment to make it safer and began doing more laboratory tests, according to his testimony. Within two years, he once again proposed the experiment the board had rejected. This time, the board approved it.

There had been scores of mouse studies suggesting that depleting T-cells worked. Many of the major breakthroughs in bone-marrow transplantation were reached in dog studies. But Hansen said it was not feasible at the time to test the theory in dogs or monkeys.

Years later, researchers at The Hutch were able to overcome the obstacles and perform T-cell experiments in dogs, according to testimony. However, Hansen said it would have delayed a promising experiment to wait for those dog studies.

The Hutch typically tried new experiments on the sickest patients, those who no longer responded to any conventional treatments and had only months to live. However, in Protocol 126, patients with at least a 50 percent chance of a cure with conventional transplants were included. In one version of the trial, half of the 22 patients enrolled had a good chance of survival; yet, all of them died.

Hansen testified there was no way for him to know the risks before doing the experiment. He said if the experiment had proved successful, the benefits to healthier patients would have been great.

"I believed I had no option but to proceed with these clinical trials, offer this to an informed volunteer, because the potential benefit was simply too great to walk away from," he said.

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