New Discrepancy in Cancer Studies Found : Health: Institute does not disclose nature of irregularity in the breast disease data. Revelation leads to resignation of leading researcher.
Federal investigators have uncovered a new discrepancy in the data from an ongoing series of international breast cancer studies but the National Cancer Institute said Tuesday that there is “no cause for concern” over current treatments for the disease.
The institute also demanded--and got--the resignation of the administrative chairman for the studies and ordered researchers involved in the $8-million project to stop enrolling new patients until an “intensive review of all records and quality assessment and control procedures.”
The cancer institute did not elaborate on the nature of the new discrepancy, nor did it name the hospital involved.
Public questions about the National Surgical Adjuvant Breast and Bowel Project arose earlier this month when a Canadian participant admitted to falsifying data in his part of the study.
The study dramatically altered breast cancer treatment patterns by concluding in 1985 that lumpectomies--the removal of a malignant lump--followed by radiation treatments, were just as effective as mastectomies in preventing the spread of early forms of the disease. Since then, a half-dozen other studies have supported that conclusion.
Although discrepancies like those uncovered in the breast cancer study can involve serious violations of scientific ethics, the project is so large and involves so much data that the institute expects no effect on overall results. The estimated 13,000 American and Canadian women now in the project will continue to receive their prescribed treatments.
The discovery of the new irregularity led to Tuesday’s ouster of Dr. Bernard Fisher, a pioneering University of Pittsburgh cancer researcher, as the project’s chief coordinator.
The cancer institute sought Fisher’s resignation because it believed that he failed to act expeditiously when initial suspicions arose over some of the data.
In a statement released late Tuesday, Fisher said that he was stepping down because “excessive administrative demands” had interfered with his own research.
“I assure the public that the published conclusions from the . . . breast cancer studies remain valid and are not compromised by any of the recent developments,” he added.
Although the cancer institute is continuing a full data analysis to further ensure that the project’s conclusions were not skewed by the false information, it said in a statement: “The institute has confidence in the standard breast cancer treatments now in use and in clinical trials that are currently in progress.”
The institute also announced “a thorough review of its internal oversight procedures” to correct any deficiencies in its own efforts to monitor and oversee research projects that it finances. At the same time, the agency created a “clinical trials monitoring branch” whose only duty will be to ensure that all cooperative research groups comply with its guidelines.
In all, the two-decade-long study involves more than 5,000 researchers at nearly 500 hospitals throughout the United States and Canada.
The initial allegations of fraud involved Dr. Roger Poisson, a surgeon at St. Luc’s Hospital in Montreal. He has admitted to falsifying the records of about 100 women to make them eligible for the study.
According to reports in the Chicago Tribune and the New York Times, the new “discrepancy,” from another Montreal hospital, was discovered Monday during an investigation of the lumpectomy studies. The reports said that Fisher became aware of it last September but did not follow up on it, in violation of project guidelines.
The cancer institute has turned over the investigation to the Office of Research Integrity, also a branch of the Department of Health and Human Services.
