A Los Angeles doctor has asked the National Cancer Institute to audit patient records at the research foundation he directs, after the discovery of discrepancies in data submitted to a major breast cancer study group that is under fire for scientific misconduct.
Among the potential discrepancies under investigation at the Memorial Cancer Research Foundation of Southern California is one case in which a woman who had died after open-heart surgery apparently was reported in study data as being alive. NCI investigators are also looking into the possibility that some of the study subjects were enrolled without meeting eligibility requirements.
A team of NCI auditors was dispatched to Los Angeles on Friday to review records at the foundation, which participated in the same series of studies marred by news that a Canadian researcher had falsified data.
The disclosure further clouds the reputation of the most prominent breast cancer research group in the country, the National Surgical Adjuvant Breast and Bowel Project. The project produced a landmark study finding that lumpectomy, in which only the cancerous tumor is removed, is as safe and effective as mastectomy, in which the entire breast is removed.
The foundation's director, Dr. David Plotkin, confirmed through a spokesman Saturday that flaws have surfaced in some of the data that his foundation submitted to studies conducted by the national project.
Plotkin contacted the NCI on Thursday to request an audit of the records of all 310 women who have participated in the study through his foundation since 1976, said spokesman Larry Weinberg.
"He believes in the verity of his work," Weinberg said. "That's not to say that there won't be anomalies or errors."
Despite the flaws that have surfaced, Weinberg said, Plotkin "is confident that the results are correct. He is certain that there is no fraud or deliberate problems, and certain that there is no malfeasance."
An NCI official said Saturday that although the full extent of the Los Angeles deficiencies are not known, he does not believe the situation is as serious as earlier allegations that a Canadian researcher falsified data.
Dr. Michael Friedman, associate director for cancer therapy evaluation programs at the NCI, said regarding the question of whether fraud was committed: "I think until our investigation is complete, we can't say anything. But the investigator (Plotkin) asked for us to examine the records. That's completely different than what happened in Canada, where the investigator certainly didn't welcome our investigation. That suggests to me that the investigator, at least in his own mind, was not worried about covering up something."
Weinbergdid confirm that the foundation had reported a woman was alive in March, 1993, when she had died after open-heart surgery in December, 1992.
The mistake occurred because the woman had changed doctors, and when the foundation called her former physician to collect once-a-year information, someone in the doctor's office informed the foundation that she had transferred to another doctor and that there was no reason to believe she was not well, Weinberg said.
Her death would have been discovered in due course as part of the foundation's regular investigations, Weinberg said.
He also said that "there is a written, signed consent form" to participate in the study for all women involved. In some cases, however, women gave oral consent before breast surgery and did not sign consent forms until afterward, he said.
Weinberg criticized a story appearing today in the Chicago Tribune, which reports that the newspaper found discrepancies in the records of some patients' records it had examined. The Tribune had reviewed the foundation's records of 18 women who were involved in a now-controversial 1985 study involving the merits of lumpectomy, Weinberg said.
NCI's Friedman said that a separate 1990 audit of the Los Angeles foundation, conducted by the NSABP, had turned up discrepancies involving five women, but neither Plotkin nor the NCI had been informed of the audit's results until recently.
Those patients were not part of the 1985 lumpectomy trial, Friedman and Weinberg said, but NCI is including them in its audit.
The discrepancies pinpointed in the 1990 audit included a patient whose chart was lacking an operative report; a patient whose chart was missing a preoperative history and evaluation, and another patient who had three estrogen receptor values listed for her cancer. Breast cancer is driven in part by estrogen, and tumors are assigned receptor values.