Hutch review won't look at troubled experiments

By Duff Wilson and David Heath

Seattle Times staff reporters

The panel appointed by the Fred Hutchinson Cancer Research Center to review its clinical-trial policies will not look back at experiments for which the center is under fire.

The committee, composed largely of Hutch donors and supporters, is examining the center's policies on protecting patients in clinical trials and on avoiding financial conflicts of interest by its doctors. But it will steer clear of investigating the two experiments for which The Hutch is being sued by the survivors of patients who died in them - experiments detailed by The Seattle Times in March.

Likewise, four independent experts hired by the panel this week to assess The Hutch's policies will not look at the experiments.

The review panel, called the Committee on Patient Protection in Research Trials, was appointed this spring after publication of The Times' investigation "Uninformed Consent: What patients at `The Hutch' weren't told about the experiments in which they died."

Although Hutch officials said the goal of the review was to restore public confidence, the committee - chaired by the Rev. William Sullivan, former president of Seattle University and a member of The Hutch Board of Trustees - has been meeting behind closed doors.

The hired experts are to finish their work by the end of this month so the review committee can make recommendations to the Board of Trustees.

The Times' articles reported that at least two dozen patients died prematurely in two failed clinical trials between 1981 and 1998 using drugs in which Hutch doctors had a financial interest, and that the patients were not fully informed about risks. Two lawsuits against The Hutch soon followed.

Dr. John Pesando, a former Hutch scientist who fought one of the experiments, said he was disappointed the committee would not look at apparent violations of law and patient protection from the 1980s and earlier 1990s.

"Those who do not learn from the past are destined to repeat it," he said. In deciding not to review the experiments, The Hutch "undermines its own credibility as it seeks to restore public faith in its commitment to protect patient rights," Pesando said.

Sullivan, meanwhile, defended the review's focus as "parallel to what is being done in a number of major cancer research centers around the country. It is completely independent of any lawsuits which have been filed against The Hutch."

Wylie Burke, chairman of the Department of Medical History and Ethics at the University of Washington, said The Hutch is facing two separate issues.

One is responding to the investigative articles. "I really think that's a discussion that needs to go on between The Hutch and the public," Burke said.

The other is reviewing current practices, and Burke said, "I think what we have heard about is The Hutch taking the first step in what most people would view as a reasonable process."

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said The Hutch "wouldn't be likely to look back with litigation flying around."

Sullivan said the Board of Trustees would decide whether to make the review committee's recommendations public.

In March, Hutch President Lee Hartwell wrote in an open letter to the public: "The findings of the audits and the recommendations of the review committee will be made available to our patients, volunteers, staff, and the public at large."

That commitment to making the reports public drew praise at the time from Dr. Richard Klausner, director of the National Cancer Institute.

But two of the experts hired this week said that in years of consulting, their reports have never been made public. The other two experts would not answer that question or any others about their work.

Sullivan has declined to be interviewed except by e-mail, and he has instructed committee members and the experts to refer all queries to him.

The experts hired this week:

* Margaret Dale, director, Office for Research Issues, Harvard Medical School. Dale, an attorney, will review conflict-of-interest policies.

* Ernest Prentice, associate vice chancellor, Academic Affairs and Regulatory Compliance, University of Nebraska Medical Center.

* Gwenn Oki, director, Research Subjects Protection, City of Hope National Medical Center and Beckman Research Institute, Los Angeles. Prentice and Oki, who often work as a team, will review Institutional Review Board policies and patient informed consent.

* James Boyett, chairman, biostatistics at St. Jude's Children's Research Hospital, Memphis. He will review protocol data and safety monitoring.

Joan Rachlin, executive director of Public Responsibility In Medicine and Research, a group supporting research professionals, said she knows Prentice and Oki well.

"They both are very seasoned auditors, which in this case is what they were asked to do, so it certainly is no inside job or given to people who would be expected to turn a blind eye or wink and nod," Rachlin said. "They're people with a lot of integrity."

But Vera Sharav, president of New York-based Citizens for Responsible Care and Research, complained, "They're all in the same club. How can they investigate each other? That's the problem here. It's self-regulating."

Allegations of wrongdoing in human clinical trials prompted similar investigations at the medical centers of the University of Pennsylvania and the University of Oklahoma in the past two years. Alan Milstein, an attorney involved in patients' lawsuits against those two schools as well as the suits against The Hutch, said those centers handled their situation differently.

"The University of Pennsylvania, while it responded to the federal agencies, accepted responsibility for the wrongdoings that occurred and, in my mind, acted with the utmost professional courtesy and responsibility," he said. "At the University of Oklahoma, they suspended virtually all human research and also decided that they needed to admit to the wrongdoings that occurred there.

"At The Hutch, they have denied everything and said that there is no problem."

In addition to Sullivan, members of the review committee are: Boh Dickey, retired president and chief operating officer of Safeco; James Dwyer, president, Sound Floor Coverings; Anne Farrell, president and chief executive officer of The Seattle Foundation; Jon Fine, president and chief executive officer of United Way of King County; Richard Guy, former chief justice of the Washington State Supreme Court; Linda Mattox, community volunteer; Shan Mullin, a partner in the Perkins Coie law firm; Marsha Pechman, a U.S. District Court judge; William Ruckelshaus, former head of the Environmental Protection Agency; and Pat Stanford and Dina Wells, community volunteers.

Mullin is chairman of the Seattle Cancer Care Alliance board, which oversees the alliance of The Hutch, Children's Hospital & Regional Medical Center and University of Washington Medical Center. He is also vice chairman of The Hutch's board of trustees.

Stanford, whose late husband, Seattle Schools Superintendent John Stanford, died after treatment at The Hutch for leukemia, is a member of The Hutch's and University of Washington Academic Medical Center's boards of trustees. Mattox and Wells are trustees at Children's. Dickey is a trustee at UW Medical Center. Pechman survived late-stage breast cancer with a stem-cell transplant from The Hutch in 1993. Ruckelshaus and his wife are major donors to The Hutch.

Sullivan said the committee has met four times and the experts have visited The Hutch twice. Sullivan said the experts will visit Seattle a third time soon and then submit written reports. He said the committee hopes to finish its review by the end of July.