Trial to open in deaths of cancer patients at Hutch

Spouses of five patients who died in a controversial medical experiment two decades ago are taking their cases against the Fred Hutchinson Cancer Research Center to trial this week.

Barring a last-minute settlement, a jury will hear allegations that the Hutch failed to tell patients the true risks of a series of experiments known as Protocol 126, in which 84 of 85 patients died.

The three leading researchers in the experiment, including Nobel laureate E. Donnall Thomas, owned stock in a biotech company whose antibodies were used.

The Hutch has steadfastly denied that it did anything wrong and argues that the researchers couldn't have profited from the experiment.

The lawsuits were filed after The Seattle Times published a series of articles three years ago called "Uninformed Consent: What patients at 'The Hutch' weren't told about the experiments in which they died." The series raised questions about whether patients were adequately informed in two controversial medical trials in which the Hutch or its doctors had financial ties.

The Times reported that from 1981 to 1993, at least 20 leukemia patients died in Protocol 126 because the bone marrow they received in transplants failed to engraft, meaning the donated cells never grew, leaving the patients without effective immune systems. Graft failures are usually rare, occurring in less than one out of 100 transplants.

The alarming rate of deaths from graft failures and cancer relapses in Protocol 126 ultimately led the Hutch to become a leading critic of the procedure tested, known as T-cell depletion.

Researchers were looking for a way to prevent graft-vs.-host disease, a potentially fatal condition in bone-marrow transplants. But there was disagreement within the Hutch at the time over whether depleting T-cells (a type of white blood cell) could lead to graft failures. One of those who voiced concerns, Dr. Rainer Storb, was conducting his own research that led to the best treatment for graft-vs.-host disease today.

Dr. John Pesando, a former Hutch researcher who became a whistle-blower on Protocol 126 and later advised the families who are suing, said he wants the case to go to trial. "It's important for the public interest that the truth get out," he said.

The Hutch has hired expert witnesses including Dr. Richard O'Reilly, chief of a transplant program at Memorial Sloan-Kettering Cancer Center in New York, who is expected to testify that Protocol 126 was well designed and in the mainstream of clinical research at the time.

Taking a chance on trial

High-stakes civil trials such as this are rare because they are so costly and the outcome can be unpredictable. Often, the two sides reach a settlement just before or after the trial begins. However, settlement talks in this suit so far have not led to an agreement.

The trial starting this week is one of three lawsuits against the Hutch that collectively involve survivors of 14 patients who died in Protocol 126, along with one marrow donor.

King County Superior Court Judge Douglas McBroom will hear motions tomorrow, with jury selection to begin Tuesday and opening arguments expected Wednesday. The trial is expected to take about eight weeks.

McBroom has already ruled the Hutch negligent in one of the five patients' transplants.

David Yingling, a 45-year-old insurance agent from Indiana, came to the Hutch in 1983 hoping a bone-marrow transplant would save his life. He had been diagnosed with acute myelogenous leukemia and was told his chance of a prolonged life with a transplant was about 20 percent.

His brother donated bone marrow, but more than 97 percent of it was lost during processing in a laboratory machine. Still, researchers depleted the T-cells from the remaining marrow — decreasing the amount of marrow even further — before transplanting it. The marrow failed to graft and Yingling died within two months.

The judge ruled that the Hutch was negligent for its mishandling of the marrow, leaving the jury to decide how much to award in damages.

Although Dr. Paul Martin, who was treating Yingling, has said he died of graft failure, the Hutch now says Yingling died of liver failure. As a result, the center says the loss of his brother's bone marrow didn't matter. Attorneys for Yingling's widow, Kathryn, expect to present evidence that his death was due to graft failure.

Kathryn Yingling works in retail near Pittsburgh, Pa.

The judge left it to a jury to decide whether the Hutch was also negligent for enrolling David Yingling in an experiment that hadn't yet been approved by the center's review board. The Hutch says this was not uncommon and was done out of compassion.

'A tragic thing'

The other patients, all of whom died of graft failure, in the case going to trial this week are:

• Ruth Fisher, a California computer programmer, who would have had better than a 50 percent chance of surviving with a standard bone-marrow transplant. She died in January 1984. Her widower, Joseph, sells equipment for chemical analysis near San Jose, Calif.

• Jacqueline Couch, a 32-year-old New York attorney, who was told she had a 50 percent chance of survival with a standard bone-marrow transplant. She died in April 1984. Her widower, Cullen Couch, is communications director of a foundation at the University of Virginia law school.

• Paul Mahler, a 41-year-old anthropology professor at the City University of New York, who also had better than a 50 percent chance of survival. He died in March 1984. His widow, Marian Dagosto, teaches anatomy to medical students at Northwestern University in the Chicago area.

• Dr. John Draheim, a 36-year-old cardiac surgeon for the Navy in Bremerton, whose odds of survival with a standard transplant are in dispute.

Draheim's case is different from the others because he was told that eight of 11 patients in an earlier arm of the protocol had graft failures. But he was given false information. The doctor who explained the trial to Draheim said in his notes that Draheim had agreed to enroll because the treatment of the marrow was different on those eight patients. In fact, the marrow he received was treated exactly the same.

Draheim's widow, Peggy Draheim, who lives with her parents in Scottsdale, Ariz., said shortly after she filed the lawsuit, "It was very important to my husband, being in the medical field, to give information to patients they may not want to hear, but information they need to make an informed decision."

That's why she feels so strongly about her husband being given wrong information. She and Dr. John Nimlos of Seattle, a close friend of John Draheim's, both say he would not have enrolled had he known all the facts.

"It's kind of a tragic thing," Nimlos said. "These weren't hopeless folks."

Dagosto, whose husband died in the experiment, agrees that not enough information was given.

"I'm a research scientist myself, and I don't see how they can justify what they did," she said shortly after filing her lawsuit.

"I keep going back and forth between sorrow and anger and guilt that we didn't ask more questions. In retrospect, I think why didn't we ask how many people have already undergone this and how did they come out? But this is medical care. It should be better than buying a used car."

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