HEALTH

Studies in deceit

A Montreal surgeon falsified cancer research

MARK NICHOLS March 28 1994
HEALTH

Studies in deceit

A Montreal surgeon falsified cancer research

MARK NICHOLS March 28 1994

Studies in deceit

HEALTH

A Montreal surgeon falsified cancer research

MARK NICHOLS

Dr. Roger Poisson is a tall, heavily built man with an air of authority that some people find intimidating. He is also known for the high level of professional care he devoted to the women he treated for breast cancer as a surgeon at Saint-Luc Hospital in Montreal. A prominent medical researcher, Poisson enrolled many patients in studies aimed at finding better treatments for breast cancer. But three years ago, Poisson’s world of power and prestige began to crumble. He was quietly stripped of his title as chief of oncological surgery at Saint-Luc and, later, as a professor of surgery at the University of Montreal. Outside a small circle of medical officials, few people knew the reasons for Poisson’s loss of status—until last week. In a shocking disclosure, medical investigators said that, over a 12-year period, the now-63-year-old Poisson had falsified data that he contributed to a series of major breast cancer studies.

The story of the falsifications—which Poisson insists amounted merely to “white lies”— shook the medical world and horrified breast cancer victims. The surgeon’s findings made up 16 per cent of the data used in an influential 1985 report that found lumpectomies— the localized removal of a tumor—to be as effective in some breast cancer cases as mastectomies, in which the entire breast is removed. “I felt panic when I saw a report of the case,” said Joan Litke, a manuscript transcriber in Springtown, Ont., west of Ottawa, who had a lump removed from her left breast in 1991. “I started wondering if I should have had a mastectomy.” In Pittsburgh, doctors in charge of the research group known as the National Surgical Adjuvant Breast and Bowel

Project (NSABP) insisted that, after excluding Poisson’s data from the study, the favorable findings on lumpectomies remained the same. Several other clinical studies have also supported the use of lumpectomies.

The revelations about Poisson’s misdeeds raised questions about why medical officials had not uncovered them sooner and, once they had, why they were so slow to inform other medical authorities— or the public. The scandal did not surface until March 13, when the Chicago Tribune published a detailed account. Poisson’s methods also created concern over the way doctors assemble data. Each year, the Bethesda, Md.-based Office of Research Integrity (ORI) investigates about 75 cases of alleged misconduct in medical studies. But Dorothy Macfarlane, a senior ORI investigator who flew to Montreal after Poisson’s actions were discovered, said that it “was easily the largest case of falsification I’ve ever encountered in terms of the number of cases and the time period over which it occurred.”

Poisson’s falsifications began to unravel after an NSABP staff member at the University of Pittsburgh noticed in 1990 that he had submitted two records of a breast cancer operation for the same patient—with different dates on them. After a seven-month investigation turned up more suspect documents, NSABP officials alerted federal investigators, who dispatched teams to Montreal. There, the full extent of Poisson’s deception was uncovered.

Between 1977 and 1990, Poisson was involved in 14 different NSABP studies, includ-

ing one aimed at determining the effectiveness of lumpectomies. Investigators found that Poisson had falsified at least 115 documents involving 99 patients. In 36 of the cases, he altered diagnosis dates in order to make patients eligible for enrolment in clinical studies. In another 39 cases, he falsified documents to make it appear that patients’ hormone levels were right for enrolment. Medical experts said that clinical studies have to operate under strict rules so that data can be accurately compared. “If patients don’t fit the criteria,” said Dr. Alan Lees, a radiation oncologist at Edmonton’s Cross Cancer Institute, “then they’re not eligible—period.”

Why did Poisson think he could bend the rules? In a written statement to U.S. investigators, the surgeon declared that his transgressions were minor and made out of compassion for his patients: “I always feel sorry for a nice case to be denied the right to enter a good protocol just on account of trivial details.” According to Dr. Pierre-Michel Huet, director of Saint-Luc’s clinical research centre, Poisson was “fully dedicated to the NSABP studies and he thought this was the best way to treat patients,” because patients in such programs receive the most up-to-date treatment and the most careful follow-up care. Other doctors speculated that Poisson was motivated by a desire for the prestige that his research work earned him— and by intellectual arrogance.

Poisson’s actions will afflict the Quebec medical establishment for some time. The U.S. National Cancer Institute, which finances the NSABP studies, has informed Saint-Luc m Hospital that it will take steps to Ë reclaim the $1 million it spent oon Poisson’s patients. Meani while, the College of Physicians of Quebec expressed concern that it only learned of Poisson’s activities from newspaper articles. “We should have been in' formed by the hospital,” said Augustin Roy, president of the doctors’ governing body. Hospital officials said they did not tell the college because they were satisfied that Poisson’s actions did no harm to his patients. For the same reason, Poisson is still on staff at the hospital. That could change. Roy said an investigator for the college will determine whether Poisson was guilty of professional misconduct—an offence that could result in suspension of his licence to practice medicine, and a further fall from grace for the once-powerful doctor.

MARK NICHOLS