Khadija Magardie
Dr Werner Bezwoda, South Africa’s top chemotherapy expert who has admitted to faking groundbreaking breast cancer trials, conducted his experiments on more than 100 indigent black women without their formal consent.
Bezwoda made his bombshell admission this month after investigators from the United States flew to South Africa to verify his research, which suggested that women with advanced breast cancer could be treated with high dosages of chemotherapy. It has now emerged the investigators could only find records for fewer than half of the 154 women on whom Bezwoda claimed to have conducted his trials at Johannesburg hospital.
Bezwoda presented his findings to the American Society for Clinical Oncology (Asco) last year, after which scientists sought to assess his novel research so as to start implementing it in the US. The US society now believes many of Bezwoda’s patients were fabricated. “You could conclude that they might not exist. You have to wonder whether a lot of this wasn’t conducted in his [Bezwoda’s] head,” Asco vice-president Dr John Durant said last week. Durant added that Bezwoda had “misled women who had hope. He has done a lot of damage to clinical trials of all sorts.”
Bezwoda resigned last year from the University of the Witwatersrand, which will hold a disciplinary inquiry into the affair in May. The head of the university’s ethics committee, Professor Peter Cleaton-Jones, said the university had no record of Bezwoda’s trials or Bezwoda’s sources of funding for the trials, which were conducted in the early 1990s. Cleaton-Jones says it is possible that Bezwoda either conducted his research as part of standard treatment procedures for breast cancer in the state hospital where he worked, or used personally accumulated funds. Cleaton-Jones said it was possible the state would launch its own inquiry into the matter. Bezwoda held the chair in medical oncology and clinical haemotology at the university.
Bezwoda’s trials suggested that extremely high dosage of chemotherapeutic agents – up to 20 times the normal level – coupled with bone marrow transplants, could have a strong impact on breast cancer.
Doctors say Bezwoda’s fraudulent trials were particularly invidious because he envisaged subjecting women to treatment with severe side effects based on his now discredited results.
High dosages of chemotherapy, followed by bone marrow transplant, has been a controversial technique, primarily because of the high costs involved – up to $100E000. And although it has worked in the treatment of some cancers – including leukaemia – it can be considered at best experimental in the treatment of solid tumours such as breast cancer.
Conventional chemotherapy alone has serious side effects, which are far more severe in the high dosages used in bone marrow transplantation. Side effects include acute nausea, partial or total hair loss, gut inflammation, infections, diarrhoea and jaundice. In the long term, such high doses can cause other cancers.
Wits has no record of the informed consent forms for the women. Cleaton-Jones said this week: “Normally when research is done on humans, the first thing we check is that they have agreed to it. We have no record that these women agreed.”
Obtaining informed consent from patients, either written or verbal, is a cornerstone of ethical scientific practice. Among other things, the patient must be informed of the benefits, risks and costs (if any) involved prior to signing the consent form. The patient must also understand that participation is voluntary, and can be terminated at any time. If the patient is illiterate, or cannot speak the language of the researcher, a social worker and/or interpreter must explain the procedure to the patient.
Clinical professors like Bezwoda essentially serve two employers – the university, and the provincial health authority. South Africa, unlike countries such as the US and Britain, does not have a formal body which monitors, investigates, and has the executive power to defrock doctors or scientists found guilty of scientific misconduct. In the US, the Office for Research Integrity has the power to, among other things, debar researchers from getting lucrative federal research grants, which in effect closes the door to unscrupulous scientists getting academic positions.
According to Cleaton-Jones, the absence of such a regulatory body in South Africa is the result of the relatively low number of cases involving scientific dishonesty, compared to other countries. But most importantly, he says, “ethics in science all revolve around trust”. He said that researchers are seldom “policed” because of an understanding in the scientific community that binds researchers to an unwritten “code” of honesty and integrity, and by extension, good clinical practice.
However, Cleaton-Jones says the university’s ethics committee, with the ethics committee of the Medical Research Council, which he also heads, is rethinking its procedures for keeping tabs on local researchers. In future, he says, it might become mandatory for researchers who submit abstract papers for consideration at international conferences to submit ethics “clearance certificates” from relevant authorities. This would be in line with the policy regarding submissions to medical journals.
Though this may be an option, at the end of the day, he says, “the responsibility for the actual honesty of the data lies with the researcher”.
But he has dealt a severe blow to the reputation of clinical trials conducted in South Africa. It also has consequences for the choices of cancer sufferers regarding treatment options. Recruitment for clinical trials is often the last hope for sufferers of a particular disease to gain access to sophisticated, advanced and costly treatment. It is possibly the chance of being afforded such an opportunity for cure that prompted many of the women who came to the state hospital to be part of Bezwoda’s study.