Serious Scientific Misconduct Alleged in Clinical Trial of High-Dose Chemo Plus Bone Marrow Transplant

The American Society of Clinical Oncology and NCI both issued news statements today regarding allegations of misconduct in a South African clinical trial for high-risk breast cancer. The trial, conducted by Werner Bezwoda, PhD, of the Univ. of Witwatersrand, Johannesburg, studied high-dose chemotherapy plus autologous stem cell transplant (HDC/ASCT) in women with breast cancer whose cancer had spread to 10 or more lymph nodes. In May 1999, at the ASCO annual meeting, five groups of researchers, including Bezwoda's, presented results from similar clinical trials. Four studies found no difference in survival between patients receiving HDC/ASCT and those receiving lower-dose chemotherapy without transplants, but the Bezwoda trial showed a significant difference in favor of HDC/ASCT. An American audit team went to South Africa to confirm Bezwoda's results and found significant deviations from standard conduct in following a research protocol.

The chair of the University of Witwatersrand Committee for Research on Human Subjects has stated that there were admissions of "a serious breach of scientific honesty and integrity" in the study and recommended that the results should "not be used as a basis for further trials." Jeff Abrams, MD, coordinator of NCI's breast cancer trials, said, "The falsification of the South African study is devastating. However, an even greater tragedy could result if this news causes patients and doctors in the United States and around the world to avoid clinical trials of transplants altogether."