FOR IMMEDIATE RELEASE TUESDAY, MAY 30, 1995

CIV (202) 616-2765 TDD (202) 514-1888

U.S. SUES CANADIAN HOSPITAL FOR $500,000 FOR BREAST CANCER RESEARCH FRAUD WASHINGTON, D.C. -- The Department of Justice today filed a suit in Canada seeking $518,175 from St. Luc Hospital in Montreal for costs the United States incurred to investigate and eliminate false data a cancer surgeon at the hospital submitted in an international study of breast cancer funded through the National Institutes of Health (NIH). Assistant Attorney General Frank Hunger of the Civil Division said the suit was filed in the Superior Court of Quebec on behalf the National Cancer Institute (NCI), which is one of the national research institutes that comprise the NIH. The false patient data were submitted by Dr. Roger Poisson in the NCI-sponsored clinical trials of breast cancer treatments. From 1980 through February 1991, Poisson was the Principal Investigator for St. Luc, one of more than 450 hospitals in the United States and Canada that participated in the NCI-sponsored project, the National Surgical Adjuvant Breast and Bowel Project (NSABP). St. Luc received $1 million in NCI funds to support Poisson's work. The University of Pittsburgh coordinated the project at the time. "Accurate, truthful reporting of patient data is essential to the integrity of NIH-sponsored clinical trials," said Hunger. "This suit affirms our commitment to pursue scientific misconduct in United States-funded research wherever it occurs." One of the NSABP studies in which St. Luc enrolled patients was among the first to report that, for many women, treatment by lumpectomy with adjuvant radiation therapy can be as effective as mastectomy. Subsequent studies by others and reanalysis of the NSABP study to exclude Poisson's falsified data confirmed the accuracy of that finding. Between 1977 and early 1991 Poisson enrolled 1,511 patients in 22 different NSABP studies of which 14 contained fraudulent data. In 1993, the Department of Health and Human Services (HHS) barred Poisson from receiving federal funds for eight years after HHS' Office of Research Integrity found he had committed scientific misconduct by including falsified data on 99 patients in his reports to NSABP. Most of the data falsifications helped ineligible patients qualify to participate in the clinical trials. The $518,175 the United States is seeking represents the portion of grant funds spent on collecting data, some of which was falsified, on the 99 patients; the costs of the investigation; the cost of auditing the records of the 1,511 St. Luc patients; and the costs of correcting studies that included the falsified data. The amount is approximately $725,445 in Canadian currency.

The suit alleges that St. Luc breached the terms of its funding agreements with NCI by providing falsified patient data to the NSABP and failing to supervise Poisson's work to prevent the falsifications from occurring. The investigation was performed by the Office of Research Integrity, with the assistance of the NCI and the Office of the NIH Legal Advisor. ##### 95-298