FDA ordered Hutch to halt leukemia study in June

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The leukemia experiment under suspension at the Fred Hutchinson Cancer Research Center was stopped last June by order of the federal Food and Drug Administration.

Previously, Hutch officials were unclear on when and why the experiment was suspended. The newly revealed details raise further questions about why an advisory committee studying research practices at The Hutch last summer was kept in the dark about the suspension.

The experiment on hold is actually three related clinical trials, under the direction of the same doctor and involving radioactive antibodies delivered through the blood to fight leukemia.

In June, the FDA wrote Dr. Dana Matthews, the principal researcher, stating that inspectors had found problems with the experiment. The agency charged that patients were misinformed about radiation doses and that doctors failed to properly report deaths and hospitalizations or to perform or document essential procedures.

The experiment was shut down while letters went back and forth between FDA and Hutch officials over the next few months. Finally, an official warning letter — a rare and serious admonishment that can lead to an experiment being ended — was sent to Matthews on Dec. 31.

The FDA's findings and warning letter were disclosed Sunday in The Seattle Times.

In a follow-up e-mail to his staff this week, Dr. Lee Hartwell, Hutch president, said the experiment was "on hold" but did not say that the FDA had ordered it, nor that it had been suspended since mid-June. Hartwell said he hoped to resolve the issues with the FDA and to resume the trials soon.

The timing and instigation of the suspension cast a shadow on the efforts and findings of a special committee appointed by the center's Board of Trustees last spring to examine how clinical trials at The Hutch are conducted. The panel was created after The Times reported on problems in two major trials conducted over nearly two decades ending in the early 1990s.

The Committee for Patient Protection in Research Trials, as the temporary panel was called, reported in September that The Hutch was in full compliance with all state and federal regulations.

Many didn't know

However, many members of the panel did not know that at the very time they were finding no problems, the FDA was finding significant problems and had ordered the radiation experiment stopped.

Jon Fine, president of United Way of King County and a committee member, says he would have liked to have had that information. Another member, former state Supreme Court Justice Richard Guy, confirmed he had not been told about the FDA's findings but declined further comment.

The chairman of the advisory committee, the Rev. William Sullivan, former Seattle University president, knew about the FDA's actions because he is also a member of the Hutch Board of Trustees. But he said he didn't discuss it with fellow committee members because he did not consider the findings final.

Other members of the advisory committee were unavailable.

Asked why the public and advisory committee weren't told about the suspension of trials last June, Hutch spokeswoman Susan Edmonds said yesterday, "We do not inform people when trials are placed on hold and then when they resume."

FDA officials would not comment on the suspension. Last week, Dr. Patricia Keegan, the agency's deputy director for clinical trials in the Center for Biologics Evaluation and Research, said the warning letter indicated "some systemic problems with the way they approach clinical trials" at The Hutch.

Matthews and another researcher involved in the experiment, Dr. Janet Eary, director of the University of Washington's Division of Nuclear Medicine, have declined requests for interviews.

Changes cited

In a letter faxed to The Times on Thursday night, Hartwell said the center has contracted with an outside organization to monitor trials and train clinical-research staff. He also said the center is about to hire an FDA regulatory-compliance officer to ensure all investigators are aware of FDA rules and enforcement policies.

"The Center has instituted many improvements to clinical-trials practices over the last year and we continue to work to tighten policies in a variety of areas to make sure we are acting in the best interests of our patients and completely within all federal and state regulations," Hartwell wrote.

Duff Wilson can be contacted at 206- 464-2288; dwilson@seattletimes.com.