JOHANNESBURGScience relies on trust, Peter Cleaton-Jones, chairman of the Committee for Research on Human Subjects (Medical), University of Witwatersrand, said in an interview about the recently discovered scientific misconduct by Werner Bezwoda, MD, PhD, a researcher at his institution. It is a case in which the South African university may have been too trusting.
Dr. Bezwodas misconduct was exposed after an independent team of US clinical investigators went to South Africa to review Dr. Bezwodas study data, hoping to embark on confirmatory trials in the United States.
To their surprise, the investigators found that the records of a study he performed of high-dose chemotherapy/autologous bone marrow transplant in high-risk breast cancer patients did not match the report he gave at the plenary session of the 1999 annual ASCO meeting (Atlanta).
At ASCO, Dr. Bezwoda said that the control patients were given standard CAF (cyclophosphamide, Adriamycin, fluorouracil(Drug information on fluorouracil)), but, in fact, as the US team discovered, they actually received CNV cyclophosphamide, Novantrone (mi-toxantrone), vincristine.
The misconduct escaped the Universitys notice because it trusted that Dr. Bezwoda would notify its internal review board (IRB) of his research, as is required by the university of all its staff. The deception also got past ASCOs reviewers, at least in part because they, too, assumed the study had undergone IRB scrutiny.
Dr. Bezwodas study was the only one of five presented at the plenary session that found a significant difference in outcome in favor of high-dose chemotherapy/transplant. His paper was also the only one of the five that listed only one authorDr. Bezwoda.
Professor Cleaton-Jones, who has served on IRBs since 1974, told ONI that is it not unusual for studies at the University to be conducted by a single researcher. The IRB at the University of Witwatersrand did not catch the discrepancies because it simply did not know that the study was taking place. We had no record of an application for this study among the 83 studies from Dr. Bezwoda mentioned in the minutes of our meetings, Professor Cleaton-Jones said. As I understand it, he was the only clinician involved in the study.
In a letter to his University colleagues, Dr. Bezwoda admitted that he had committed a serious breach of scientific honesty and integrity, and took sole responsibility for the misconduct.
At the request of Professor Cleaton-Jones in his capacity as IRB chairperson, the University has begun a formal inquiry into the scientific misconduct in accordance with the international ethical standards that the University upholds, and in terms of the Universitys disciplinary code, the University said in a statement.
The University will also conduct an institutional audit of all of Dr. Bezwodas research, and other staff members have been appointed to oversee the research that Dr. Bezwoda was supervising.
Professor Cleaton-Jones told ONI that the committee will introduce new measures to prevent such deceptions, although the exact measures have not yet been formulated. He explained that research sponsored by pharmaceutical companies is easily monitored. The companies are very ethical and give us annual reports. It is the investigator-driven/investigator-funded trial that is hard to monitor.
He said that in his more than 25 years of experience serving on IRBs, he knows of only one country that has a national monitoring system for all research, including clinical trials conducted by independent investigatorsnamely, the United States with its Office of Research Integrity.
Aetna Drops ABMT for Breast Cancer
The news from South Africa that the single trial reporting success with high-dose chemotherapy/autologous bone marrow transplant (ABMT) in breast cancer is based on bogus data may have spurred a major US health insurer to change its policy on the procedure.
Aetna/US Healthcare has informed physicians that it will no longer provide reimbursement for transplants in breast cancer patients, unless they are enrolled in a federally sanctioned clinical trial of the procedure.