FOR IMMEDIATE RELEASE CIV

TUESDAY, MAY 30, 1995 (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.
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