Mike Fancher / Times executive editor
The story behind today's special report on 'The Hutch'
Seattle Times executive editor
Seattle is home to several institutions and enterprises of world renown, none more respected than the Fred Hutchinson Cancer Research Center.
With a mission no less than "eliminating cancer as a cause of human suffering and death," the center has saved thousands of lives in its 25 years of existence. People with scant chance of surviving cancer come from all around the world to find hope and life at "The Hutch."
Its staff of 2,300 employees is supported by some 1,400 volunteers, a reflection of the special status it has in the hearts of people here. The Hutch is a source of pride in this community.
Knowing all of that, The Seattle Times also knows that readers will be troubled by today's special report, "Uninformed consent: What patients at `The Hutch' weren't told about the experiments in which they died."
Certainly, the thrust of The Times investigation by Duff Wilson and David Heath is stark: Patients died prematurely in two failed clinical trials in which The Hutch and its doctors had financial stakes. The patients and their families were never told about the financial entanglements, nor were they fully and properly informed about the risks of the experiments. Both trials were continued for long periods despite evidence they were failing.
What reader would not find that disturbing?
But some readers also will be troubled that The Times is telling such a story about an institution as revered as The Hutch, one that has done so much good over the years. Some may even question our methods or motives. So, let me explain the origins of this story and our reasons for telling it now.
The Times was alerted to this story by two independent sources, both urging us to investigate. The concerns they raised could not be ignored.
One source was a physician who had served on The Hutch's Institutional Review Board, which is charged with overseeing medical experiments involving human patients. He had tried for years to end the first clinical trial because of what he saw as medical and ethical problems with it.
The other source was the son of a patient who died in the second of the clinical trials. He was alarmed by things he had learned after his mother's death.
Rather than simply report their concerns and provide the center's response, we chose to investigate them ourselves, to see if we could determine their truth. It turned into a long and very exhaustive investigation.
We examined some 10,000 pages of documents from federal, state and medical sources.
We interviewed dozens of people, including medical experts, patients and their families. To the degree officials at The Hutch would talk with us, we interviewed them, too.
To a very large extent, we relied on analyses done by the researchers themselves. When Hutch officials refused to make material available to us, we obtained it by filing information requests under federal law.
When the reporting and writing were done, we had an independent expert in bone-marrow medicine review it for technical accuracy.
In the end, we found troubling ethical and legal issues in the two clinical trials, which tested drugs owned by companies in which Hutch doctors held stock, advisory positions and, in some cases, jobs.
The most problematic aspects concerned what patients were and were not told before they consented to participate in the trials.
The emphasis of our series is not to question the science or medicine in these trials, although some critics do. Our primary aim is to question what patients have a legal right to know, and in these cases weren't told.
It is one thing to debate whether a terminally ill patient should enter a risky experimental-treatment trial that offers only a remote chance of a cure. It is another thing entirely if the patient hasn't been told the full extent of the risks, the alternate treatments available or the financial interests the doctors have in the substances being tested.
In the two Hutch trials we're reporting on, it's clear patients didn't get full disclosure. In fact, they were misled.
The Hutchinson research center is not unique in struggling with issues of how clinical trials are conducted and regulated and of potential conflicts between medical and financial interests. Later this year, Congress will hold hearings on the subject nationally.
But the problems at The Hutch are dramatic examples of the potential pitfalls when medical researchers have financial ties with private biotechnology companies. They raise obvious concerns not only for the patients involved but also for the general public, which supports such research with government grants and personal contributions.
We hope our stories help inform the policy discussions around how clinical trials are conducted, and how patients are protected from possible conflicts between medical and financial interests.
Web site offers more detail
We encourage readers to follow the series through the coming four days, and to explore beyond it by visiting our Internet site, at www.seattletimes.com. The Web site offers original source documents, background articles and Web links on the history of the subject, including relevant laws and standards.
Finally, as always, we welcome your comments and questions.
If you have a comment on news coverage, write to Michael R. Fancher, P.O. Box 70, Seattle, WA 98111, call 206-464-3310 or send e-mail to firstname.lastname@example.org.