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1994.04.13 : ORI Investigating Hospital in Montreal 

Contact:  Public Health Service/HRSA 
Wednesday, April 13, 1994
Public Health Service 
(202) 690-6867 
NCI, 301-496-6641 


     The National Cancer Institute and the Office of Research 
Integrity today announced that ORI has opened a formal investigation 
into allegations that falsified data were submitted from St. Mary's 
Hospital Center, Montreal, for patients entered in the National 
Surgical Adjuvant Breast and Bowel Project clinical trials.  The 
allegations were referred to ORI by NCI two weeks ago.  

     The investigation has uncovered five instances of potentially 
falsified data involving three patients entered in the Breast Cancer 
Prevention Trial. 

     The possible falsifications involve changes in dates of tests 
required either to establish eligibility for the trial or to follow- 
up patients.  In one instance, a laboratory value appears to have 
been altered to meet eligibility criteria. 

     Based on the available information, neither ORI nor NCI 
believes the identified misstatements affect the results of the 
prevention trial.  

     They appear to be limited to the Breast Cancer Prevention 
Trial, no results from which have been published, and do not affect 
treatment trials carried out at the same hospital. 

     The ORI is continuing the investigation to determine the full 
extent of the problem and who is responsible for the data 
falsification. 

     ORI does not routinely make public statements about open 
investigations.  However, because of prior publicity involving this  
investigation and concerns from the patient community regarding the 
validity of the NSABP studies, ORI believes that this public 
statement is needed to provide accurate information to the  public 
and the scientific community. 

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