By Roy Benaroch, M.D., Emory University
Science, using well-designed experiments and trials, is the best tool for figuring out answers to health questions. But one has to admit the dark side of science as well: Scientific studies can be skewed by bias, shoddy design, or sometimes even by outright fraud like in the case of Dr. Bezwoda.
A Randomized Trial, Dr. Bezwoda
In 1995, a researcher from South Africa, Dr. Werner Bezwoda, published a groundbreaking paper in the prestigious Journal of Clinical Oncology. It was titled, “High-Dose Chemotherapy with Hematopoietic Rescue as Primary Treatment for Metastatic Breast Cancer: A Randomized Trial”. Dr. Bezwoda had shown that a therapy—a dangerous and expensive therapy—was remarkably effective against advanced breast cancer.
His statistics showed that 51% of women given his protocol, including high, almost lethal doses of chemotherapy followed by a bone marrow transplant, achieved remission of their cancer, compared with a dismal 2% of women using conventional therapy.
The Implementation of the Study
The idea for using bone marrow transplants for breast cancer had been proposed decades before this, and women around the world were already receiving this kind of therapy, sometimes having to pressure their insurance companies to pay for it. However, no previous study had shown that it was more effective than conventional therapy.
In fact, small earlier studies had reported a high mortality rate from the therapy itself, and European and American oncologists hadn’t been seeing close to that 50% cure rate. But there it was, published in a peer-reviewed scientific journal, and Bezwoda’s study became very influential. Women worldwide were offered this new therapy, and life or death decisions were made based on this study.
This article is based on a recap published in 2016 in the internet magazine Ozy, titled “The Fraudulent Study that Killed Millions of Breast Cancer Patients.” It turned out that the Bezwoda study was false, and the hope it offered wasn’t real. The data from this study was fabricated.
Learn more about new drugs on the block.
The Dark Side of Science
We know that science, using well-designed experiments and trials, is the best tool for figuring out the answers to health questions. But we have to admit the dark side here, that the methods of science aren’t perfect and that scientists don’t always follow the rules. Scientific studies can be skewed by bias and shoddy design, or sometimes by outright fraud.
Inspection of Dr. Werner Bezwoda’s Study
In the Bezwoda case, a team of oncologists became suspicious of his work, traveling to South Africa in 2000 to review his data after the paper was published. What they found was a tangled mess of poor documentation, deceptive study enrollment, and some outright lies.
Bezwoda’s paper was published in 1995, and he continued to present data from the paper and from subsequent patients at meetings over the next several years, even while skepticism and calls for more transparency grew.
This is a transcript from the video series The Skeptic’s Guide to Health, Medicine, and the Media. Watch it now, on The Great Courses Plus.
Discreditation of Dr. Werner Bezwoda’s Study
The story broke in the press in February 2000, with stories like this one from The New York Times: “Breast Cancer Researcher Admits Falsifying Data.”
The story jumps right to the meat of the issue in the first two sentences: A South African researcher has admitted that he falsified data and is retracting a widely publicized study claiming that bone-marrow transplantation and high-dose chemotherapy could prolong the lives of women with advanced breast cancer.
Admission of Fraud and Subsequent Retraction of the Study
(Image: Arda Savasciogullari/Shutterstock)
The admission of fraud came only after a team of American scientists visited the researcher’s laboratory to examine his records and found that they did not match what he had reported.
It didn’t take long for the admission to change how the therapy could be used. Eleven days later, another New York Times headline read, “Insurer Drops a Therapy for Breast Cancer.” One of the U.S.’s top insurers, Aetna, had announced that they would no longer cover the astronomical costs of this therapy unless the patient was enrolled in a legitimate study. One month later, the study’s lead author was fired from his university position, and in June 2001, about six years after it was published, the study was formally retracted from the Journal of Clinical Oncology.
Scrutinizing Dr. Werner Bezwoda’s Fraud
So what did Bezwoda actually do? After the smoke cleared and the allegations were made public, ABC News covered the facts in their 2001 article “Breast Cancer Study Retracted.”
The ABC story includes important details about the investigation. Fifteen-thousand sets of medical records from the two Johannesburg hospitals where the study was done were scoured, and only 61 of the 90 patients in the publication had any records at all. Of those 61, only 27 had enough detail to know if the women should have been eligible for the study; and of those 27, most should not have been in the study at all—some had the wrong kind of cancer or the wrong stage of cancer.
Only seven of the 61 women, whose records could be found, had survived; and some of those never even received the study protocol treatment. There was no evidence that any patients were randomized, and some treatment records appeared to be entirely fabricated.
Learn more about the media and the Internet.
Other Ethical Issues with the Study
There were huge ethical issues with the study, too. None of the records showed that any of the women had consented to the treatment, and many of the women who were supposedly enrolled were illiterate and couldn’t have understood what they were signing up for. In short, this was very bad science, about as bad as it could possibly be.
In retrospect, there were red flags from the beginning: starting with how one oncologist could have possibly found so many women who would agree to enroll in this study, something doctors in other countries couldn’t come close to matching. But the results were so promising and so exciting that they were taken as gospel for several years until an independent group of oncologists did the legwork to uncover the truth.
The deceit unraveled quickly, but in the meantime, many women were subjected to a risky and worthless therapy.
The Penalty for a Science Fraud
Dr. Bezwoda was dismissed from his job, and he just faded into obscurity. Cases of fraud like this are rare, but rarer still are times when researchers face criminal charges or jail time.
In the U.S., a former Iowa State scientist was sentenced to over four years in prison for research fraud, but the charges focused on his misuse of federal grant money rather than his faking the data. In China, a court decision calls for very stiff sentences, including the death penalty, for scientists falsifying research records.
The Real Plague Affecting Science
The health-oriented news site STAT helped put cases like this in perspective in their 2016 essay, “The Real Plague Affecting Science? It Isn’t Fraud.” They reported on a study done by Dutch researchers surveying working scientists around the world about misbehavior among their colleagues and its impact. Though fraud was obviously ranked very high in terms of a negative perception of science and public trust, it occurs so rarely that the overall impact of fraud didn’t make their top five list of science problems.
Quoting the study authors, “A picture emerges not of concern about wholesale fraud but of profound concerns that many scientists may be cutting corners and engaging in sloppy science, possibly with a view of getting more positive and spectacular results that will be easier to publish in high-impact journals.” In this anonymous survey, about 2% of researchers admitted committing fraud, while a third said they had taken questionable steps like cutting corners in their work.
Common Questions about the Dark Side of Science: Dr. Bezwoda’s Cancer Study
In the U.S., a former Iowa State scientist was sentenced to over four years in prison for a research fraud, but the charges focused on his misuse of federal grant money more than his faking the data.
Fraud isn’t very common in scientific studies, though, scientists cutting corners and employing sloppy science is.
According to an anonymous survey, about 2% of researchers admitted committing fraud, while a third said they had taken questionable steps like cutting corners in their work.
