Breast Cancer: a Diagnosis of Deceit

It takes an extraordinary amount of self-confidence to wield a scalpel with skill, but most surgeons never approach the audacity of Dr. Roger Poisson. From 1977 to 1990, the French-Canadian physician falsified data on scores of patients so that he could enroll as many people as possible in important research studies on the treatment of breast cancer. To conceal the deception from the trial’s American coordinators, the former head of oncology at St. Luc’s Hospital in Montreal kept a double set of medical files labeled “true” and “false.” His office even submitted progress reports for one woman two years after her death. “In the strict sense, I did bend the rules,” Poisson admitted during an investigation by the U.S. government. However, he added, he “did not consider white lies for the purpose of practical logistics as a breach of my honor.”

Maybe not. But last week, after the Chicago Tribune broke the news of Poisson’s misconduct, it was clear that his “white lies” were a breach of science’s code of honor. Physicians were aghast, government officials were embarrassed, and breast-cancer victims were fretting about whether they had received the best treatment. Coming in the wake of a whole series of highly publicized allegations of fraud in the scientific world — some unjustified — the clear-cut case against Poisson dealt a new blow to the reputation of the research community. Said a federal scientist involved with the investigation: “This was not sloppiness. It was real cunning fabrication.”

The Poisson affair was so unsettling because his work dealt with matters of life and death. One of his main studies was part of the research that led in 1985 to a major change in the way surgeons treat breast cancer. Until that time, patients almost always had the entire breast removed — a mastectomy. But the new research showed that a less disfiguring procedure called lumpectomy — in which only the tissue surrounding the tumor is cut out — is just as effective when the cancer is in its early stages.

Experts were quick to reassure patients last week that the disclosures about Poisson’s work did not undermine the evidence of the value of lumpectomies. His research was part of a much larger study, and when his statistics are removed, the conclusions do not change. And other studies have had the same results. Even with such assurances, many patients were still uneasy. Said Donna Brogan, an Emory University biostatistician who had a lumpectomy in 1986: “The whole research enterprise operates on trust among scientists. When someone betrays that trust, it is upsetting.”

Equally disturbing was the way some scientists knowledgeable about the case — and some government officials — kept quiet about Poisson’s misdeeds for years. The fraud was detected in 1990, Poisson admitted at least some culpability in 1991, and yet most patients and doctors didn’t learn of the problem until the Tribune publicized it in 1994. To many, the affair smacked of a scientific cover-up.

Under the covers were a strange assortment of offenses. In general, Poisson violated the rules of the study he was part of, making his results not comparable with the data from other researchers. For example, the study required that the patients be operated on within 28 days after breast cancer was diagnosed. But Poisson let women into the study who had waited a longer period of time before having surgery. When necessary, he falsified dates in the reports he sent to the study’s coordinators at the University of Pittsburgh. Asked later to explain his actions, the doctor said he was trying to make advanced treatment — financed by research grants — available to as many women as possible. But Poisson’s work had other flaws, including reports on lab tests never done.

There is no evidence, however, that any patient was harmed by what the doctor did. “The irregularities were very minor,” Poisson told Time. “But the way they are described ((in news accounts)) looks very awful.” On one point he is adamant: he did not order up progress reports on a dead woman. A staff member did that without his knowledge, he claims, and has been fired.

Poisson’s motivation may have been a desire to make his studies as big and successful as possible. Observes Dr. Jacques Jolivet, a cancer specialist at Montreal’s Notre Dame Hospital: “Poisson’s a proud man — proud to say that he puts most of his patients in trials, proud to get grants, proud to get his name on research papers. It was a long ego trip. He just lost it at one point and wound up twisting the data.”

After Poisson’s Pittsburgh collaborators discovered the fabrications in 1990, they turned over the evidence to the U.S. government. The Office of Research Integrity made its own investigation and documented 115 instances of fraud. By February 1993, ORI had found Poisson “guilty of scientific misconduct.” He declined the opportunity for a hearing, and a brief summary of the investigation was published in the June 1993 Federal Register.

Poisson was demoted at his hospital and barred from participating in U.S.-funded research for the next eight years. The National Cancer Institute started considering ways of retrieving $1 million in funding given to Poisson. Yet there was no retraction in the scientific press, no contrite announcement at a cancer conference. “Not everyone reads the Federal Register,” complains Dr. Jerome Kassirer, editor of the New England Journal of Medicine, in which two of the disputed studies were published. “It would have been nice to have known in case we needed to prepare a response.”

Why did neither the government nor the University of Pittsburgh get the word out to doctors and patients? Their answer: scientists quickly determined that the scandal wouldn’t affect the current wisdom about how to treat breast cancer; there was no need to alarm people unnecessarily. “We knew we weren’t facing a public-health disaster,” explains Dr. Dorothy Macfarlane of ORI.

Dr. Bernard Fisher, the Pittsburgh professor who directed the breast-cancer studies, feels no need to apologize for his handling of the situation. “We were the ones who determined there was a fraud,” he says. Fisher points out that government officials told him not to discuss the case publicly until their investigation was finished. That was more than a year ago, but, says Fisher, his summary of the case needed to be reviewed by many colleagues before publication. He promises that a 50-page report will become available later this spring and that he is rushing a letter to the New England Journal.

Many doctors and their patients would have preferred to know much sooner that serious doubts had been raised about a major breast-cancer study. “I was shocked,” says Dr. Freya Schnabel, a breast surgeon at Columbia-Presbyterian Hospital in New York City. “When these things happen, it’s better to air it out promptly and let everybody know about it right away.” That’s the way science is supposed to work.

CHART: NOT AVAILABLE

CREDIT: American College of Surgeons

CAPTION: CHANGING STRATEGY

Use of different breast-cancer treatments as a percentage of all cases

In 1985 new research established the effectivness of lumpectomies.