Good medicine, bad journalism

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From a teenager dying in a gene-therapy trial at the University of Pennsylvania to a woman dying in a Johns Hopkins University asthma trial, botched clinical trials have been much in the news lately. As reporters scramble to uncover the latest scandal in biomedical research, it is too easy to leave the balanced story aside in favor of the "gotcha" one that demonizes researchers or sensationalizes a bad outcome in an experimental treatment.

As both a journalist and a cancer survivor, I have been dismayed to see how little critical review can go into the process of rewarding such journalism. In recent months, several of the most prestigious institutions in journalism have heaped awards on the March 2001 Seattle Times series called "Uninformed Consent"; there's even talk of a Pulitzer.

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 were owned by companies in which some doctors themselves had a financial stake.

Fundamentally false

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 afterward — 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 percent 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 die 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.

Do no harm

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.

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