Uninformed Consent

Clinical Trials at Fred Hutchinson Cancer Center

The below articles are:

Good Medicine, Bad Journalism
Taste: Tedium on Deadline --- The American press could learn from those (lively) hacks it disdains
Letters to the Editor: Good Journalism, Bad Medicine -- 3/25/02
Letters to the Editor: Good Journalism, Bad Medicine -- 3/27/02
Some thoughts on the Uniformed Consent articles

Good Medicine, Bad Journalism

In a nutshell, the newspaper accused the Fred Hutchinson Cancer Research Center in Seattle of killing patients two decades ago during clinical trials being conducted in an effort to find a safer method of bone marrow transplantation. Further, it charged that the doctors, including a Nobel Prize winner, did not adequately inform the patients of the risks in the trial, and did not disclose that drugs used in the procedure where owned by companies in which some doctors themselves had a financial stake.

As someone who studied every aspect of those trials carefully and reviewed all the medical literature before deciding to seek a bone marrow transplant at the center in 1992, I believe that the Seattle Times portrayal of events, while it certainly made for a dramatic tale, is fundamentally false. Rather than racking up prizes, it should be used as a textbook case on how the media can convey biased and misleading information about biomedical research. It left out crucial facts, distorted others and ignored everything that didn't fit its sensational thesis.

Until the center, known as the Hutch, helped pioneer bone marrow transplants in the 1960s, a diagnosis of leukemia used to be a death sentence. Transplanting marrow from a healthy donor offered a cure for thousands of people. But in the early days, it was a difficult and often fatal procedure; even if patients survived the transplant process, they often could not survive the side effects known as graft-versus-host-disease.

In an effort to prevent it, the Hutch and every other transplant center in the world began experimenting with the removal of T-cells, known as the soldiers of the immune system, from donor marrow. It seemed like a promising solution, but it turned out to have a problem the researchers had not anticipated: When the T-cells are removed from donor marrow, the transplant is not effective, so patients were relapsing and dying after all.

The Hutch, discovering this problem, was the first major transplant center to end the trials, switching its focus to the use of new drugs to prevent and treat graft-versus-host-disease. By contrast, some of the most prestigious cancer centers in the country, including Memorial Sloan Kettering in New York, continued to experiment with T-cell removal for many years afterwards -- and are still working on versions of it to this day. The Seattle Times completely ignored this crucial fact, and did not place the Hutch's experience with T-cell removal in the context of what was going on at its peer institutions in the field. The Hutch, rather than the irresponsible player it is portrayed to be in the Seattle Times, was in fact the first major cancer center to acknowledge that the experiment with T-cell removal was not working, and end it.

Did people die after T-cell depleted transplants during the early phase of clinical trials? Yes, at the Hutch, and every center that used the procedure, all over the world. Leukemia patients who were in mortal danger with slim chances of survival participated in an experiment of a new treatment that gave them hope, but no guarantees, of a cure. Would they have survived if they stuck with the conventional transplant, as the Seattle Times contended? Impossible to say. This is the way the inexact science of cancer research progresses, by trial and error, and to suggest that there was any wrongdoing in this case is reckless.

The Seattle Times used as its primary source a disgruntled former Hutch employee, Dr. John Pesando, who originally filed a complaint with the U.S. Department of Health and Human Services in 1993 about the trials in question. After a two-year investigation, HHS's Office for Protection from Research Risks determined there was no wrongdoing or failure to comply with policy on protecting human subjects. After the stories ran, the Washington State Department of Health also investigated and determined last October that there were no violations of ethics or conduct.

The patients the Seattle Times portrays as dupes were clearly informed of their risk as it related to their individual situations, including the risk of death. And while it is legitimate to question whether some doctors at the Hutch should have had any business relationships with a drug company, there is no evidence that any doctor was driven by financial interests, let alone that the hospital continued the experiments after patients died because it stood to benefit, as the Seattle Times suggests.

The result of the stories was predictable enough: suits against the hospital filed by relatives of the patients who died. Though the suits have been denied class-action status, the legal morass continues. In its effort to show the impact of its stories, the Seattle Times appears also to have overstepped the bounds of ethical reporting: Documents produced in the legal proceedings that have been ongoing for the last year indicate that one Seattle Times reporter has been functioning as a de facto adviser to the plaintiffs and urging them to assert various claims against the hospital. Worse still, such legal actions could have a chilling effect on scientific discovery, if patients were to sue every time a clinical trial didn't work.

The true impact of such stories is likely to be the last thing responsible journalists would intend: frightening patients away from new treatments that may save their lives, confusing readers about the role of research in new drugs and therapies, and unfairly smearing the reputations of a responsible institution and its professionals. The Seattle Times series was one of the stories singled out in a report by the Association of Clinical Research Professionals as conveying to the public the sense that "medical research involving human subjects is fraught with dangers and abuses."

But the Seattle Times is far from alone. The association's analyses of 75 articles about clinical trials published in major newspapers in the year ended January 2001 found that 55 of them were negative enough to discourage a reader from volunteering for a clinical trial. The group's survey of its own clinical research coordinators and research associates membership found that 75% believe media reporting about clinical research has "created confusion and fear among the public."

No one doubts that the media have a crucial role to play in explaining the way clinical trials work and acting as a watchdog. Last year, 80,000 trials were conducted in the U.S., from pharmaceutical company labs to top cancer research centers. While most trials are safe, there are risks: According to the Food and Drug Administration, one in 30 patients in clinical trials experience serious adverse effects; one in 10,000 dies as a result of those effects.

Tough new standards are being put in place that will govern the way clinical trials are conducted, requiring full disclosure of any financial conflicts of interest and demanding immediate reporting of any adverse events. Research professionals are already undergoing rigorous new training and certification programs, and new safeguards are being put in place to monitor patient recruitment and treatment, including making sure they fully understand the "informed consent" forms they fill out explaining the risks.

Clearly, researchers have a big job ahead of them as they work to reassure the public, safeguard patients and combat negative images of clinical trials. There is no question that protections 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.

But in its slanted and sensationalized reporting on the Fred Hutchinson Cancer Research Center, the Seattle Times committed the sin journalists are often accused of, and must always be on our guard against: disregard for the complete story in the interest of the most dramatic one. Perhaps the media needs to adapt its own version of the Hippocratic oath for investigative medical reporters: First, do no harm.

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Ms. Landro, an assistant managing editor at the Journal, is author of "Survivor: Taking Control of Your Fight Against Cancer" (Simon & Schuster, 1998).

(See related letter: "Letters to the Editor: Good Journalism, Bad Medicine" -- WSJ March 25, 2002)

(See related letters: "Letters to the Editor: A Medical Institution Under Attack" -- WSJ March 27, 2002

Taste: Tedium on Deadline --- The American press could learn from those (lively) hacks it disdains

In hell, my coffee would be British, my hygiene French, my jailers German and my newspaper American. (Readers will assume, as I do, that The Wall Street Journal would not be available there.)

I hang these observations up for scrutiny but propose only to dwell on the subject of newspapers -- and not merely because the other points are too uncontroversial to merit discussion

An episode this week proves journalistically instructive. It centers on Laura Landro, a senior editor at this newspaper. On Tuesday, the Journal's features page ran a piece by Ms. Landro titled "Good Medicine, Bad Journalism," in which she criticized a Seattle Times series thought to be in the running for a Pulitzer.

Writing of the series, which focused on alleged malpractice at a hospital, she said: "Rather than racking up prizes, it should be used as a textbook case on how the media can convey biased and misleading information about biomedical research."

The reaction to Ms. Landro's piece was swift, especially (as you might imagine) from the Seattle Times. The New York Times picked up the story but spun it in a way that says much about American journalism: "With Prizes Near, Paper Prints Attack on Another's Entry."

Felicity Barringer, who wrote the Times piece, chose to focus in her first paragraph on Ms. Landro's apparent solecism (Ms. Barringer called it a "highly unusual step"): to wit, denouncing the Seattle Times' series "less than a month before the announcement of the Pulitzer Prizes." Later Ms. Barringer again said: "The most startling aspect of the challenge for many journalists was its timing."

As a journalist who once worked for a British newspaper, I found Ms. Barringer's take on the affair rather striking. For a start, there ought to be nothing more delicious -- to a journalist -- than to see the pages of one paper attack those of another. But the underlying thesis of the report was that Ms. Landro had broken the rules of the club to which she belongs by being beastly to her fellow journalists just at the moment when (gasp!) they were up for a prize. I may be naive, but isn't that precisely the point at which one should kneecap a dubious contender?

Embedded in the criticism angled at Ms. Landro is the belief that a reporter's words, once printed in a serious paper, acquire a near sanctity. This view is further nourished by the sense among American journalists that they belong not to a bruising profession but to a priestly class. How different from the British approach, where reporters, in healthy self-deprecation, refer to themselves as "hacks." And if a British journalist had suggested that it was somehow not on, mate, to put the boot into another paper's story merely because it was up for an award, he'd have been laughed right out of the pub.

No one would suggest that British newspapers are inherently superior to American ones. In many respects they are quite the opposite. They take liberties with facts, and they rely heavily on unnamed sources, often hanging entire stories -- even highly charged ones -- on a single veiled source.

British newspapers disregard the lines between fact and opinion, and the tabloids -- bless them if you will, or damn them -- often fail to distinguish between fact and fiction, or reporting and advocacy. But at the top of the scale -- with broadsheets such as the Daily Telegraph or the Guardian -- the writing is often very fine, and invariably lively. This may be because, as national newspapers, they have a certain metropolitan panache, and none of the provincial diffidence that is a hallmark of many American papers. Their liveliness may also owe something to the fact that their writers are less constrained by the Objectivity Police than their American counterparts.

Objectivity, in fact, has become something of a fetish with American papers. Melvin Lasky, the editor of the now defunct Encounter magazine, and author of "The Language of Journalism," was scathing in this regard when I picked his brains over the telephone yesterday. Mr. Lasky lives in Berlin and was describing the effect of American practices on German newspapers. "In 1945," he said, "the Germans were suckers for the simple American credo -- stories should be objective, not subjective, there should be a rigid separation of fact from comment, and all that stuff. You can't do that without producing a very boring newspaper. It was the death of German papers, until years later, when they returned to their own traditions."

According to Mr. Lasky, a typical American story might run like this. Lin Po Foo drank his second cup of tea. He looked through the window. He looked at his plastic teacup. This, in his hands, was the fate of thousands of ceramic teacup manufacturers in Indonesia. A British newspaper, by contrast, wouldn't bother with Indonesia (and certainly not that second cup of tea) unless thousands were being slaughtered.

Where is the golden middle? Mr. Lasky thinks it's in the Frankfurter Allgemeine Zeitung, which, like some other German papers, has emerged from the "American shadow." He describes the paper as "half Richard Wagner, half Cole Porter," as well as "the best in the world." Why? Because it veers neither toward meretricious entertainment, as the British press does, nor toward the general bloodlessness of American reportage. It believes in a judicious marriage of fact and comment and assumes that it is possible to educate a reader while entertaining him. In other words, it avoids fetishes and has neither a prevailing dogma nor a complete absence of one.

This last contrast between the American way (dogmatic) and the British (insouciant) is being played out at the New York Post. A recent spat there -- in which an American editor, fired by the paper's Australian editor in chief, complained that she was let go because she's not Australian or British -- provides another opportunity to compare the world's two great newspaper cultures. (For the purposes of analysis, let us treat Australian journalists as being a species of Fleet Street Hack.)

The British school regards journalistic output as perishable, and a tabloid hack's role as essentially disruptive. It stands to reason that an American practitioner of the journalistic arts might find the Post today to be unfamiliar terrain. British-style tabloids tend to go for impact, at whatever cost, and the cost is often high in terms of collateral damage. These battle conditions require tough, leathery soldiers who will wade through minefields in the daytime and drink the fatigue away in the evening. Ergo Aussies and Brits.

This kind of journalism is stacked against those who worry about special interests, and who are forever nervous about the consequences of a story on a particular group, be it ethnic, sexual or religious. The British school, whatever its failings, is good at giving offense. Americans, by contrast, are good at not giving it. This makes them better people, for sure. But does it make their papers better?

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Mr. Varadarajan is the Journal's deputy editorial features editor.

Letters to the Editor: Good Journalism, Bad Medicine

I am writing in response to Laura Landro's editorial-page commentary, "Good Medicine, Bad Journalism" (March 19). Ms. 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. 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

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, nor that second transplants were known to be fatal 95% 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 actually 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' Web site (www.seattletimes.com) and The Center's (www.fhcrc.org) to make their own judgments.

Ms. Landro 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 farther 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 died in the second of the clinical trials. He was alarmed by things he had learned after his mother's death.

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.

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.

Mr. 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, Mr. 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 Mr. Wilson's written communications with the families from long before the series was published. Their argument: If, in the course of the reporting, Mr. 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 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. The series has already won a number of national awards, of which the 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 2001 suspended three clinical trials that remain closed down today.

Instead of attacking a report published a year ago, Ms. Landro should have written an editorial 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.

Michael R. Fancher
Executive Editor
The Seattle Times
Seattle, Wash.

Letters to the Editor: A Medical Institution Under Attack

I applaud Laura Landro for exposing the tawdry journalism practiced by the Seattle Times in its crusade against the Fred Hutchinson Cancer Research Center ("Good Medicine, Bad Journalism," editorial page, March 19). As a hematologist/oncologist who practiced for more than 30 years, I admire the fine work done at the Hutch. I had countless occasions to refer dreadfully ill patients to the Hutch for bone marrow transplantations.

All these patients were treated within clinical research protocols, were treated with consideration, professional thoroughness and human empathy such as is seen in few institutions; they had nothing but respect and appreciation for the efforts expended in their behalf

Regrettably, the behavior of the Seattle Times is not an isolated example of the sensationalism so often associated with the reporting of medical issues. In its attempt to create a scandal in Seattle, where quite the contrary is the case, the Times reveals how shallow medical reporting can so often become. That there should be talk of awards for this type of behavior is even more appalling. It is obvious that the Times reporters did not make any real effort to understand their subject matter or to place it in perspective.

Bruce D Boselli, M.D.
Sayre, Pa.

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I was one of the founding scientists in 1981 of the biotechnology company, Genetic Systems Corp. (GSC), discussed by the Seattle Times in its series on the Hutchinson center. I can verify unequivocally that the Seattle Times series was filled with falsehoods and half-truths.

One example: The series implied that scientists at the center were doing trials so that they could financially benefit from ownership in GSC stock and help the company in its development of cancer drugs. However, GSC did not have a commitment to cancer therapy. Indeed, we were so concerned about the risk of going into the cancer therapy market as a small company, we decided to partner with other companies and form a separate entity, Oncogen, as a safer strategy. Furthermore, the "cocktail" of anti-T cell reagents used to remove T cells from patients' bone marrows came from a number of different sources, inlcuding those where no deals or commerical rights had been obtained. There was simply no viable product that could have stemmed from the Hutchinson's cocktail. Yet the Seattle Times chose to put side by side a time line showing the changing value of GSC stock held by Hutchinson investigators, including now Nobel Laureate E. Donnell Thomas, coupled with events occurring at the center. The strong message was that the center's scientists were being driven by greed, when in fact they were driven by outstanding scientific ideas and true love and compassion for their patients. I just wish the journalists doing such damaging writing could be held accountable to the truth.

The fact that this kind of scurrilous trash is being considered for a big journalism prize is really shocking to me.

Edward A. Clark, Ph.D.
Professor of Microbiology
and Immunology
University of Washington
Seattle

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I've worked on clinical trials for more than 22 years, which including stints in both cancer institutions cited by Ms. Landro. I also have a keen interest in how health-care issues are reported.

Sensational reporting on only parts of a story from 20 years ago is obviously absurd. Unfortunately, many people who read these articles in the Seattle Times translated the reports to mean that many of the cited problems with trials are problems at the Hutch today. This is far from the truth. Subsequently, as Ms. Landro reported, reputations were damaged and people were hurt.

There is no doubt that there is a role for the media to bring problems concerning clinical trials to the nation's attention. However, it needs to be done in a more professional manner than the Seattle Times's series. The Hutchinson center is by far the most ethical health-care institution I have worked in.

Stephanie Mehl
Seattle

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As someone whose mother died in 1993 while participating in one of the experiments at the Hutch that was the subject of the Seattle Times's article, I disagree strongly with Ms. Landro's accusations, and believe the articles to be fundamentally true and courageous.

In support of her arguments, Ms. Landro notes that she had a positive experience at the Hutch when she received a bone marrow transplant in 1992. While this may be true, it does nothing to undermine the legitimacy of the Times story about many patients, including my mother, who were misled or not given critical information when deciding to participate in the clinical trials in which they died. In my mother's case, she was promised a rescue drug that, it was hoped, would allow her to tolerate what was otherwise a lethal dose of chemotherapy. But she was not told that the drug was not available in intravenous form -- the only form she could tolerate.

Ms. Landro also argues that because other research institutions were conducting studies in the 1980s that were similar to the T-cell depletion experiments at the Hutch, the Hutch must have done nothing wrong. She does not discuss how those other institutions carried out their studies, but if they, like the Hutch, were failing to inform patients of the risks of those studies, and of less risky alternative treatments, hopefully they will come under similar scrutiny. She also notes that prior investigations of certain of these experiments found no wrongdoing, but the more detailed analysis in the Times articles shows these investigations to be superficial, at best.

The numerous articles that have been published in the last few years documenting the problems with and dangers of clinical research have indeed caused some skepticism. Ms. Landro worries that this will have a chilling effect on clinical research. Perhaps. But the fact remains that studies have shown that most people participating in Phase 1 drug studies -- which are designed for sole the purpose of determining the toxicity of the drug being studied -- participate with the hope that the "treatment" will make them better.

Clinical research is, of course, vital to medical advancement, but noble goals do not justify careless means. The Times articles exhaustively documented that in certain clinical cancer trials at the Hutch, patients were not fully informed of known risks of the experiments in which they died, and were not given full information about alternative therapies.

Chris Addicott
Seattle
(Mr. Addicott is a business and real estate attorney, and is the author of "Regulating Research on the Terminally Ill, a Proposal for Heightened Safeguards.")

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As a recent transplant patient treated at the Hutchinson last year, I can tell you I have the utmost respect for the oncologists and support personnel. I was part of a new clinical trial for multiple myloma that uses a new protocol to try to reduce not only the return of the cancer but also the mortality from graft vs. host disease. It is an ongoing battle to find better ways to treat cancer and reduce the toxic side effects that still kill many patients even today.

William N. Stokes, D.D.S.
Roanoke, Va.

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As a cancer survivor and someone whose interest in medicine takes several forms -- such as establishing philanthropic ties to institutions -- I applaud Ms. Landro's article. The media has long been known to favor the sensational over the factual. But when it comes to reporting on medical research trials, journalists must be careful to think about the second and third order of consequences. If patients become too frightened by irresponsible journalism, all of us suffer without the valuable information those trials afford the medical field. The more we are able to learn, the more lives will be saved in the future.

Amy Perella
New York
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Credit goes to Ms. Landro for setting the record straight on what is best described as shoddy reporting by the Seattle Times in relationship to the Fred Hutchinson Cancer Research Center.

Over the past 20 years, I have had the honor to work with many physicians and scientists at the Hutch. To a person, they are impeccable individuals who are devoted to their research and dedicated to the patients they treat. Their clinical innovations have saved countless lives in a field that has historically had dismal results.

Unlike the investigators at the Hutch, the Seattle Times reporters appear to have started with a conclusion, generated a hypothesis, misrepresented the data and concluded what they had always assumed. This is not the scientific method, nor should it be considered journalistically acceptable behavior.

Roger W. Evans, Ph.D.
Rochester, Minn.

REVIEW & OUTLOOK (Editorial)

Tort-Lawyer Journalism

Any significant challenge to the accuracy or fairness of an entry, such as published letters, corrections, retractions, as well as responses by the newspaper, should be included in the submission.

-- from Pulitzer Prizes, How to Submit an Entry

The other day we devoted nearly a complete letters column to a lecture on our journalistic responsibilities from Michael R. Fancher, executive editor of the Seattle Times. He rambled on about this and that "irony" in an attack by our Laura Landro on his newspaper's series "Uninformed Consent," which is reportedly a finalist for a Pulitzer Prize.

The biggest irony, it seems to us, is that we published Mr. Fancher's Letter to the Editor. The Landro piece to which he objects is an elaboration of a Letter to the Editor she submitted to the Seattle Times a year ago; the Times refused to publish her views in its letters column. If it had, according to the rules quoted above, it would have had to include her letter with its Pulitzer submission. That the spirit of this rule can be evaded by not publishing a strong challenge is an irony the Pulitzer Board might want to ponder.

The burden of "Uninformed Consent" is an allegation of improper paperwork in medical studies done nearly two decades ago at Seattle's Fred Hutchinson Cancer Research Center. The "informed consent" forms did not describe the risks of the experimental procedures, it argues, and 80 of 82 leukemia patients died. The dead patients are not in a position to explain what their doctors told them or what was in their minds in consenting. The forms are written for lawyers, and contingency-fee lawyers are now suing the center on behalf of the patients' heirs.

The suits were not filed, Mr. Fancher pathetically explained, until after the expose was published. Yes, the ambulance went by back in 1985, and was pretty much forgotten until the Times dug up the tracks, along the way applying to the older trials today's medical knowledge and informed-consent standards. Even accepting at face value Mr. Fancher's explanation of his reporter's role as an intermediary between heirs and lawyers, what we have here is an example of tort-lawyer journalism.

Journalists often find themselves in alliance with the plaintiff's bar because both are propelled by the evidence of dramatic anecdotes. It scarcely matters that carefully conceived experiments find that, say, the morning-sickness drug Bendectin does not cause birth defects, or that silicone breast implants do not produce auto-immune disease. Wave a deformed child or suffering implant patient before a reader and you have a headline-grabbing story. To the plaintiff's bar, you also have a potential class-action jackpot.

In medical research this is a heavily tilted game. You can find anecdotes about the patient who was injured by an experimental drug. You cannot collect anecdotes from patients who would have been helped by the same drug but were denied access to it because of safety fears. The Seattle Times series largely concerned a failed medical experiment. Doctors had reason to hope that removing T- cells from bone-marrow transplants would stop graft-versus-host reactions; instead they found that such transplants usually did not help (though they are still used in certain applications).

So we now have heirs and their lawyers to speak for leukemia patients who were not helped during one medical dead end. But we typically would have no one to speak for leukemia patients who benefited from the larger thrust of the same research. This is where Laura Landro comes in.

In 1991 she was diagnosed with chronic myelogenous leukemia, a dread form of the disease. She researched the disease and its treatment, including the T-cell depletion experiments of which the Times wrote years later. Though a resident of New York with several excellent cancer centers, she chose to travel to Seattle to be treated at Hutchinson. The marrow transplant worked, and she went on to write a book, "Survivor: Taking Control of Your Fight Against Cancer."

According to Mr. Fancher's idea of journalistic ethics, this makes her unfit to write about the issues raised by his series. She not only succeeded in her fight with cancer but established herself as an assistant managing editor of this newspaper. But since she owes her life to the center, she is biased in its favor. She replies, "This is insulting, patronizing and also, frankly, sexist -- as if I am some bubbleheaded woman who can't separate emotions from professionalism."

Mr. Fancher finds no bias, however, among heirs with a potential financial interest in speculative lawsuits about deaths back in 1985. But for the record: The Seattle T-cell depletion experiments were part of a national and international trial; Hutchinson was the first center to discontinue its part of the trial. The disgruntled former employee who was the principal source of the Times series also complained to medical authorities, but a two-year investigation by the National Institutes of Health found no material ethical violations. A letter from the Institute's Office of Protection from Research Risks can be found on the center's Web site.

We are concerned with this issue on two levels. One is journalistic professionalism; it is not a credit to our craft that "Uninformed Consent" has already won several journalistic awards. But even more seriously, we have long felt that medical research needs to be liberated, not inhibited. Some experiments will fail, but more patients will suffer if medical advances are tied up in lawsuits or medical bureaucracies.

We are on the side of patients who need and want advanced, if speculative, technologies -- that is, of the patients for whom Laura Landro speaks so eloquently

REVIEW & OUTLOOK (Editorial)

Righteous in Seattle

The Seattle Times' executive editor, Michael Fancher, has responded to our editorial last Wednesday criticizing his newspaper's cancer journalism by demanding a correction.

He says we were wrong to report that the Times didn't submit as part of its Pulitzer Prize entry a critical letter from our Laura Landro. While the Times didn't publish or submit her letter, he says, it did submit a letter she wrote to the Columbia Journalism Review. They ask us to believe that other submissions were just more compelling than one from a top-flight journalist who'd published a book on surviving cancer. Other Times editors have peppered the media gossip site of Poynter.org with similiar claims

We're happy to share with readers this insight into Mr. Fancher's standards of accuracy. Ms. Landro's original letter to the Times, the one it refused to publish, ran to about two-and-a-half pages. The letter that CJR ultimately published was slashed from roughly the same length to two paragraphs. This is the letter Mr. Fancher brags that the Times submitted to the Pulitzer judges. By the way, Columbia University administers the Pulitzers, so any editor with a room temperature IQ knows you'd better submit anything critical from its Journalism Review.

All of this only reinforces our view that what really needs correcting is reporting standards in Seattle. The rest of the press corps seems to be treating this as little more than intra-media spat, as if it's rude to challenge a fellow journalist's work. But they aren't addressing the substance of Ms. Landro's critique.

Readers who want to see Ms. Landro's letters in their entirety, as well as Mr. Fancher's note to us and an independent scientific review of the Times' cancer series, can find them on our Web site, OpinionJournal.com

Some thoughts on the Uniformed Consent articles

The authors of these articles do not appear to really understand BMTs, or how clinical trials works. They take items out of context and use them to support their views. It certainly seemed to be the case that there was the appearance of conflicts of interest between Hutch doctors' financial interests and the interests of their patients, but it did not seem to me that there was a "smoking gun" pointing to patients who were harmed because of that. The articles on "The Breast Cancer Experiment" (protocol 681) seemed like they were much ado about not much. They start with how dangerous this new drug (PTX) was and then use a story about a woman who took the drug but part of her problem was that when ever she took it she almost immediately threw it up (i.e. the pill was visible in the vomit). If this were true it seems very unlikely that the drug did much of anything, good or bad. The most bogus part, in my opinion was their comparision of the treatment related deaths in this trial (approximately 6% of the patients, 4 out of 68 patients died from the treatment) to other cancer trials (I guess that is what "these types of cancer trials" means). A mortality rate of 6% for autologous bone marrow transplants in the early 1990s was actually fairly good, particularily if they were increasing the doses of chemo used in the preparative regimen.

I also found some of their statements about Protocol 126 to be misleading at best. For instance, they say that GVHD is fatal "about 5 to 10 percent of the time". I believe that while this may be true now it was not at all true in 1981 when this trial was started. They seem to claim that GVHD was a well understood problem, which certainly was not true in 1981 (and arguably is not now). They give the example of a 38 year old woman with leukemia that was "mild form that could be bothersome but not fatal for many years. She also had a perfectly matched sibling donor for a bone-marrow transplant. With the standard treatment, she had a 60 percent likelihood of being cured." I do not know exactly what a "mild form" of leukemia is (I actually can not imagine a mild form of any disease that is fatal), but I assume it is a chonic form, presumably CML. It is hard for me to believe that someone that old in 1984 had a 60% chance of cure from CML, although the odds are probably someone better then that now.

But, ...

Even ignoring these mistakes, the fact remains that T-cell depletion -- protocol 126 with minor modifications went on for more then 10 years and that 80 out of 82 patients who were enrolled in that study are now dead. While there may have been scientific concerns when this study was started, T-cell depletion was being explored at many centers around the country, so I do not think that this trial should have never been started (which is what the articles seem to imply). However it should have been clear several years sooner then it was not working and the trial should have been stopped. It seems to me that there was not enough oversight of at least this trial at the Hutch at that time. If this has not changed by now, then it needs to change.

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