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Date: Friday, June 23, 1995
For Release: Immediately
Contact: Rayford Kytle (202) 260-3388

Kerr has appealed the decision to the HHS Departmental Appeals Board. The Departmental Appeals Board will independently review the ORI finding against Kerr. That process should take approximately six months. Because Jones did not appeal the finding against her, it is now final.

ORI has prohibited Jones from serving in any advisory capacity to the Public Health Service for three years and required a supervisory plan for any PHS-supported research on which Jones is involved, for three years. Kerr faces the potential of similar sanctions if the Departmental Appeals Board affirms ORI's findings in the pending appeal.

These findings of scientific misconduct will not change the overall results of the study of the drug tamoxifen as a breast cancer preventative. The questioned data at St. Mary's will be excluded before any findings are reported.

Kerr was found to have fabricated the dates of examinations and the results of laboratory tests to ensure the eligibility of one woman seeking to enter the Breast Cancer Prevention Trial, and fabricated laboratory results and falsified dates of laboratory tests used to follow the progress of another woman entered in the trial.

Jones was found to have fabricated the date of an electrocardiogram required for entry in the trial, stating the test had been done prior to entry when it had not. She was also found to have falsified the dates of examinations of another participant to meet eligibility requirements for the study.

Kerr and Jones were the only individuals found responsible for the falsified and fabricated information.

The findings end the investigation of allegations related to the Breast Cancer Prevention Trial at St. Mary's Hospital Center by the Office of Research Integrity, U.S. Public Health Service.

ORI said that because of the falsifications and fabrications of Kerr and Jones, inaccurate data were entered into the clinical trial database for three women enrolled in the study. However, the database has now been corrected. No scientific reports affected by the false data have been published, ORI said, and no clinical recommendation have been based on them.

ORI said that the National Surgical Adjuvant Breast and Bowel Project (NSABP), its Breast Cancer Prevention Trial, and St. Mary's Hospital cooperated fully with the investigation, as did the National Cancer Institute (NCI), whose audit of NSABP files led to the investigation.

The final report of the investigation has been reviewed by the NCI, NSABP leadership, and the Breast Cancer Prevention Trial's independent end results, safety monitoring and advisory committee. They agreed that:

• St. Mary's could continue to participate in the Breast Cancer Prevention Trial pending approval of a corrective action plan that would provide tighter control and supervision of all aspects of data collection and quality control. The principal investigator already has submitted such plans to the National Surgical Adjuvant Breast and Bowel Project.

• The 44 participants for whom no irregularities were found should continue in the prevention trial and be included in future analyses of the study.

• This incident does not jeopardize the validity of the findings from the prevention trial, which involves more than 11,000 women. Analyses of the trial will be run both with and without the data from the participants who were determined to be ineligible after randomization. Any publication of these analyses will include full disclosure of the scientific misconduct and will account for all randomized patients.