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), 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
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