Argument over patients' consent starts Hutch trial

The Fred Hutchinson Cancer Research Center assigned curable patients to its riskiest experiment 20 years ago, and as a result they died, an attorney for the spouses of five patients argued in the first day of trial yesterday.

Some of the patients had a 50 percent chance of being cured with a standard bone-marrow transplant, said David Breskin in his opening statement at the King County Courthouse. Breskin's clients have sued the Hutch, seeking unspecified damages for the deaths of their spouses.

The patients "were assigned to this protocol without their knowledge," Breskin said. "The first time they heard about this protocol, if at all, they were already in the hospital room in a hospital gown with a Hickman catheter in their arm.

"They were never told, 'The purpose of this experiment is to see if you are going to die from graft failure,' " Breskin said. Graft failure is when the transplanted marrow fails to grow. "No one would give up a 50 percent chance of a cure rate for an experiment."

Lawyers for the Hutch countered that all the patients were fully informed about the experiment. They produced slides of the individual consent forms each signed explaining the patients would be in a research trial.

And the lawyers said all bone-marrow transplants at that time were experimental.

"There was no such thing as a 'standard' bone-marrow transplant," said Hutch lawyer Bill Leedom. "Even today, there is no such thing as a 'standard' bone-marrow transplant."

"The culprit in the deaths of these five unfortunate people was leukemia," said George Mernick, who also represents the Hutch.

The patients were enrolled in a controversial series of experiments, known as Protocol 126, that ran from 1981 to 1993. The experiments were intended to find a way to prevent graft-vs.-host disease, a potentially fatal side effect of a bone-marrow transplant.

In the end, 84 of the 85 patients in Protocol 126 died, at least 20 from graft failure, a problem that typically occurs in less than 1 percent of transplants. Today, the Hutch is a leading critic of the procedure that was tested, known as T-cell depletion.

A key issue in the trial will be whether the doctors knew graft failure was likely from the start, and whether they should have stopped the experiments once patients started dying from graft failure.

Before approving the experiment, the Hutch's own review board initially rejected the experiment because not enough animal research had been done and because of fears of graft failure. But attorneys for the Hutch said the doctors didn't know graft failure would be a problem until patients in Protocol 126 started dying from it.

The Hutch intends to call a lengthy list of expert witnesses from some of the nation's top research centers to testify on its behalf. Yesterday, its attorneys showed jurors that research centers around the world were doing similar T-cell depletion experiments.

Doctors named as defendants include E. Donnall Thomas, a Nobel laureate for his pioneering work on bone-marrow transplants. Thomas sat with co-defendants Drs. John Hansen and Paul Martin in the front row of the courtroom yesterday, just a few feet from the spouses of the five patients who died.

The doctors each owned thousands of shares in a company whose antibodies they tested in Protocol 126. For that reason, the families argue that they were motivated by greed. Breskin quoted from a memo written by the director of the Hutch at the time, Dr. Robert Day, acknowledging that there was a conflict of interest.

The Hutch argues that the company couldn't have made profits from the antibodies because the company wasn't interested in commercializing T-cell depletion and because another company owned the patents on the antibodies.

Mernick said of the conflict, "The evidence will show you that this is a red herring."

The first witnesses will be called Monday. The trial is expected to last eight weeks.

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