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The lumpectomy fraud. Poisson, the National Surgical Adjuvant Breast Project, and a crisis of ethics.

IN 1985, THE National Surgical Adjuvant Breast Project (NSABP) published the findings from its clinical trial, NSABP-B06, that compared lumpectomy with or without irradiation with simple mastectomy.1The results of this trial suggested that although local recurrences were reduced by the use of radiation, survival was not different among the three modes of treatment. At that time, an accompanying Editorial2commented that "perhaps an historical debate may be nearing resolution." By then, it appeared that survival following the development of breast cancer was probably not influenced by the nature or extent of the operative procedure or by the use of radiotherapy. THE CURRENT ETHICAL DILEMMA In recent weeks it has been disclosed that a physician, Roger Poisson, MD, of St Luc Hospital in Montreal, Quebec, had submitted falsified data to the B-06 lumpectomy study. Poisson had contributed approximately 18% to 19% of the cases in that study, although