Good journalism, bad critique

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Laura Landro owes her life to the Fred Hutchinson Cancer Research Center. Suffering chronic myelogenous leukemia, she was saved by a bone-marrow transplant at "The Hutch" in 1992. She is devoted to the center, as anyone of her experience would be.

When The Seattle Times published a series of articles called "Uninformed Consent: What patients at 'The Hutch' weren't told about the experiments in which they died," Ms. Landro was one of the first to publicly condemn the work. But that wasn't the first time she had made her feelings known. Even before the series was published, Ms. Landro informally approached an editor of The Times urging that we stop. She argued that we would hurt a stellar institution and, by extension, risk people's lives.

She made much the same case in an editorial column in The Wall Street Journal on Tuesday, as she had earlier in a letter to the Columbia Journalism Review. She claims The Times' extensive series is fundamentally false, yet she fails to offer a single factual inaccuracy. She asserts that we neglected to provide proper scientific context, yet many of the very points she makes about T-cell depletion can be found in our series.

Unfortunately, Ms. Landro is unable to separate her own experience as a patient from her duties as a journalist.

There are two powerful ironies to Ms. Landro's efforts to discredit The Times. The first is that had she gone to The Hutch eight years earlier, she would have been a candidate for enrollment in one of the clinical trials on which the series focused. In that trial, 80 of the 82 patients treated died, although many of them stood good odds of survival with conventional bone-marrow treatments.

The other irony is even more important because Ms. Landro is a crusader for cancer patients. She wrote a book based on her own experience called "Survivor: Taking Control of Your Fight Against Cancer," from which all of the proceeds go to The Hutch. Yet she attacks The Times for reporting that patients were deprived of critical information before deciding to enroll in highly experimental treatments.

The thrust of the series, published March 11-15, 2001, is that patients died prematurely in two failed clinical trials in which the center and its doctors had a potential financial interest. The patients and their families were never told about those monetary connections, nor were they fully and properly informed about the risks of the experiments.

For example, in one experiment involving T-cell depletion in bone-marrow transplants, the informed-consent form told prospective patients that graft failure was "possible" and could be corrected by a second transplant. What it didn't say was that graft failure and cancer relapse were occurring at an alarmingly high rate, far higher than with conventional approaches, and that second transplants were known to be fatal 95 percent of the time.

The patients in these trials were ill with cancers that, left untreated, would almost certainly have killed them. But many stood a good chance of survival or at least prolonged life with more-conventional care. Instead, many died from the experiments — sooner than they would have with no treatment at all.

In the aftermath of our investigation, an advisory committee appointed by the center's board of trustees recommended landmark reforms that would be the toughest consent and conflict-of-interest rules in the nation. While the center has yet to take any action on the recommendations, they would bring changes that Ms. Landro should applaud.

Interested parties should view The Times' Uninformed Consent site and the center's (www.fhcrc.org) to make their own judgments. We believe the series, the follow-up stories and the original documents on which the reporting was based are rock-solid and overwhelmingly persuasive. We have published the questions and criticisms by Hutch officials and have responded to each. The work speaks for itself.

Ms. Landro's column, "Good medicine, bad journalism," suggests the Times reporters scrambled to uncover the latest "gotcha" scandal in biomedical research, that the newspaper "sensationalized a bad outcome in an experimental treatment." Nothing could be further from the truth.

The Times was alerted to this story by two independent sources, both urging us to investigate. One source was a physician who had served on The Hutch's Institutional Review Board, which is charged with overseeing medical experiments. 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 had 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 whether we could determine their truth. It turned into a long and exhaustive investigation. We examined about 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.

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.

The emphasis of the series was not to question the science or medicine in these trials, although some critics do. The Times' primary aim was to question what patients have a legal and ethical right to know and in these cases weren't told.

Ms. Landro also accused one of our reporters of unethical conduct, claiming he has acted as a legal adviser to plaintiffs who have sued the center over their family members' deaths in the experiments. That charge is meritless.

The reporter, Duff Wilson, has worked closely with several families since he began reporting on this story in 1998. We could not have told the story without their cooperation, as they provided the previously private patient records of their deceased loved ones. None of the families filed suit against The Hutch until after the series was published.

Wilson since has stayed in continuing touch with families as sources of information, and in one e-mail he provided to some of them the address of the Washington Medical Quality Assurance Commission — an address that had appeared in the newspaper with our original stories.

In fact, Wilson and the other reporter on the series, David Heath, have taken great care to keep their distance from the lawsuits against The Hutch, to the extent of refusing to connect potential plaintiffs with the attorneys handling the cases.

Notably, attorneys for The Hutch have attempted to subpoena Wilson's written communications with the families from long before the series was published. Their argument: If, in the course of the reporting, Wilson indicated to the families that there were problems in the experiment, the families had only one year from that point to sue. The Hutch is saying in essence, "We didn't do anything wrong, but if we did, you missed your chance to sue us."

The Hutch's continuing legal battle with these families is, we believe, a factor in the effort to discredit our stories.

The Hutch is not unique in struggling with issues of how clinical trials are conducted and regulated. But the trials examined by The Times are dramatic examples of the 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.

The report was intended to help inform the policy discussions around how clinical trials are conducted and how patients are protected from possible conflicts between medical and financial interests. Sadly, Ms. Landro conceded in an interview with The New York Times that the motivation behind her column was to discredit the series to prevent it from winning further journalistic recognition. The series already has won a number of national awards, of which The Seattle Times is proud.

Far more gratifying than awards, however, would be action by The Hutch's board of trustees to enact the recommendations of its advisory committee. Even after our series was published, the federal Food and Drug Administration found that The Hutch was not providing proper informed consent to patients, and in June it suspended three clinical trials that remain closed down today.

As Ms. Landro said in her column, "There is no question that protection for human subjects in clinical trials is one of the most important issues in science today, as is the issue of financial relationships between researchers and drug companies."

Instead of writing a column attacking a report published a year ago, Ms. Landro should have written a column calling on officials at The Hutch to do the right thing: put the needed safeguards in place. Give patients a better chance to take control of their fight against cancer.

Ms. Landro's book is a must-read for anyone facing cancer. Her central point is this: "The key to survival is taking control, learning everything you can about your treatment, making informed decisions and being prepared to fight for the right care, for the right doctors and, in the end, for your own life. Had I not done this, I might not be alive today."

Had The Hutch operated under the recommended safeguards, perhaps other cancer patients would still be alive today as well.