A Wits University professor’s admission that he faked clinical trials has rocked the international medical community, reports Khadija Magardie
The University of the Witwatersrand is poised to decide on the fate of the disgraced head of its haematology and clinical oncology department, Dr Werner Bezwoda, who has been accused of misrepresenting the results of a clinical study into breast cancer treatment.
The outcome of the inquiry could strip Bezwoda of his professorship, and a lucrative private practice. The academic, well-respected in cancer research circles, admitted late last month to tampering with the results of a controversial study into the treatment of breast cancer.
The case is the biggest scandal to hit the Wits scientific community in the past four decades. It raises serious questions as to why the university’s ethics committee, which is supposed to screen and approve all research involving humans, was apparently side-stepped with relative ease.
But the saga has also had crucial implications in the United States, where medical experts have been considering investing heavily in his techniques. The saga has made headlines in the US, appearing in the Wall Street Journal, The New York Times and The Washington Post. Dr Jeff Abrams of the US National Cancer Institute told the Wall Street Journal: “The falsification of the South African study is devastating.”
Last year, Bezwoda presented a paper at a 12E000-strong conference convened by the American Society of Clinical Oncology on the results of a trial he had conducted into curing breast cancer.
Bezwoda’s presentation, one of five at the meeting, showed that high-dose chemotherapy followed by bone-marrow transplantation was more effective than standard doses in treating women with cancer.
Bezwoda conducted clinical trials on 154 South African women with high-risk breast cancer. His research findings presented at the conference showed an increased survival rate and lower relapse rate among women who received high-dose chemotherapy, compared with women receiving standard doses.
The study, which contradicted the finding of all the other researchers who made presentations, was hailed as ground- breaking evidence that high-dose chemotherapy could produce better treatment results. But on January 31, in a letter to the head of the department of medicine at Wits, Bezwoda admitted to faking certain aspects of his research. He admitted that he committed “a serious breach of scientific honesty and integrity”. He claimed he was motivated “out of a foolish desire to make the presentation more acceptable”.
Members of the oncology research community said that Bezwoda was most likely motivated by the prospect of scientific prestige and recognition – and not financial gain – since there is no process of patenting cancer treatments.
The drugs Bezwoda gave the women in his control group – women who were supposed to be on standard-dose treatment – were not the same as those he cited in his research report. He tested the high-dose patients against a group of patients he claimed were on the conventional regimen of drugs, but who were in fact on an entirely different experimental group of drugs.
Bezwoda handed in his resignation from his position at the university four months before the case became public. Researchers in the field were alerted to possible ethical problems following the visit to South Africa by US scientists who were sent to South Africa to assess Bezwoda’s techniques. Following suspicions over the absence of certain patient data, the researchers alerted the university, who took prompt action to suspend Bezwoda, pending an audit of all his research. It was then that Bezwoda made his extraordinary admission about the trial.
The usage of high-dose chemotherapy, followed by bone-marrow transplants, has always been a controversial technique, and the discrediting of Bezwoda’s research will deal a huge blow to the therapy’s advocates.
This week, the largest health insurer in the US, Aetna/US Healthcare, announced that it would no longer provide reimbursements for the treatment, which costs up to $100E000. The insurance firm reviewed its position after it was disclosed that Bezwoda’s study, one of the few to support the treatment, was unreliable.
In future, women with breast cancer will only have access to the treatment if they are in a valid federal research study, or part of clinical trials by oncology research institutes.
It is bound to come as a cruel blow to thousands of women who, encouraged by the findings of early-stage research like Bezwoda’s, believed the treatment was their only hope for survival.
Speaking in an interview with Reuters earlier this month, representative for the American Society of Clinical Oncology Dr John Durant said it was unfortunate that Bezwoda did not “play straight”, at the expense of women and the society’s credibility. It is the first time in the organisation’s 35-year history that it has been forced to recant a peer-reviewed study that had been accepted for presentation. Durant also announced that the organisation planned to review its screening procedures for trial results.
Clinical trials are research studies in which people at increased risk for disease participate. These trials often offer more options for care, and greater access to the latest treatment, particularly if it is costly.
According to Professor Peter Cleaton- Jones, who heads Wits’s committee for research on human subjects (medical), the case has had a detrimental effect on the research reputation of the university. In a letter to the American Society for Clinical Oncology, Cleaton-Jones, on behalf of the faculty and the university, “humbly apologised for the hurt and embarrassment” the matter caused the society. Oncology organisations have lauded the university for taking prompt action against Bezwoda, as well as publicising the nature of the inquiry.
Cleaton-Jones highlighted the fact that the committee, less than an hour after it became aware of the allegations, took prompt action to notify the relevant authorities, as well as to suspend Bezwoda. However, he has not been able to explain how Bezwoda’s research was continued without the approval of the ethics committee.
Scientific establishments worldwide have independent ethics committees, which all medical research involving people is subject to. The committees ensure that in all cases there is “informed consent” by participants.
Cleaton-Jones said the committee had on file more than 80 research projects undertaken by Bezwoda, but not the one in question. He said he hoped the outcome of the inquiry would explain how Bezwoda managed to circumvent the research protocol laid down by the university.
Abrams said he hoped the news would not deter women from joining future clinical trials.
Bezwoda, who was contacted at his private practice premises in Rosebank this week, refused to comment, saying the matter was still under investigation by the university.