Hutch's former review chief tells of unease at experiment

Dr. Henry Kaplan, now one of Seattle's most-respected cancer doctors, felt very uneasy about a medical experiment being conducted at the Fred Hutchinson Cancer Research Center 20 years ago.

At the time, he was chairman of the center's review board, and his job was to protect patients. Kaplan and the board had heard about an experiment known as Protocol 126 in which leukemia patients with a good chance of survival were doing poorly and in which the doctors might have had a financial conflict of interest.

"We were nervous about the whole situation," Kaplan said in court yesterday, testifying on behalf of families suing "The Hutch" for the death of five patients.

Kaplan, testifying in the trial's third week, told of his efforts to get the center to bring in outside experts to evaluate the medical experiment.

As a cancer researcher himself at Swedish Hospital, Kaplan knew the rules for doing clinical trials, but he didn't feel qualified to judge these types of experiments. The Hutch had pioneered bone-marrow transplants, a new and radical form of treatment for blood cancers such as leukemia, and now was experimenting with so-called monoclonal antibodies. Doctors hoped the antibodies would be the "magic bullets" to kill cancer cells without killing normal cells.

Kaplan testified that there was tension between his review board and The Hutch. "On the one hand, this was a world-class institution. ... On the other hand, we had concerns about what we were seeing."

Kaplan expressed these concerns, including the possible financial conflicts, in a letter to Dr. E. Donnall Thomas, a founder of The Hutch who later became a Nobel laureate.

Thomas replied in an October 1983 letter that there were no financial conflicts. "I think the committee members have not only an obligation to review the ethical aspects of this work," he wrote, "but also an obligation to assist us and not impede our research."

Kaplan testified, "I had the impression that the scientific staff were irritated that we may be delaying their research."

He then wrote to the center's director, Dr. Robert Day, in November 1983 saying that the review board "strongly recommends" an outside review by experts to evaluate studies such as Protocol 126 that were using monoclonal antibodies. Kaplan raised his concerns again in a meeting with Day in January 1984.

Day agreed only to an internal review. He also agreed to stop enrolling patients in the experiment who had good odds of survival, Kaplan testified.

However, evidence shows that after the January meeting, three more patients with good odds of survival were enrolled in Protocol 126 and then died.

Kaplan's testimony was consistent with parts of the testimony of Dr. John Pesando, a key witness for the families who sued The Hutch. Pesando was a doctor who treated patients at The Hutch and also served on its review board with Kaplan.

To prepare for his testimony, Kaplan said he'd asked The Hutch for the detailed minutes of the review-board meetings, which he remembered seeing. The Hutch was unable to produce them, he testified. The missing minutes included discussions about his and others' concerns about Protocol 126.

Kaplan, who also is on The Hutch's list of witnesses for the trial, praised the doctors being sued as "excellent physicians whom I have a great deal of respect for."

He said he doesn't believe that they would continue an experiment if they knew patients would die as a result.

Kaplan said if he had been able to get proof from experts that the experiment was flawed, he would have voted to stop it. But in the end, he said, he trusted that The Hutch doctors knew what they were doing.

"While I was uneasy about it," Kaplan said, "I felt these guys were the experts at it."