The Fraudulent Study That Killed Thousands of Breast Cancer Patients
WHY YOU SHOULD CARE
Because one man’s wish for success can put a lot of people at risk.
By Kristina Gaddy
Aurora Langley believed her only hope for a cure back in 1994 was a radical treatment her insurance company didn’t want to cover. She had five children, a husband and a life to live, so she enlisted friends, family and her community to raise money to pay for the brutal but hopefully lifesaving treatment. Halfway around the world, one doctor was proving that this treatment was a cost that patients should be willing to endure.
Dr. Werner Bezwoda, after all, was a magician known for curing late-stage breast cancer. In the 1990s, chemotherapy was the hope for a cure — the more the better. At the University of Witwatersrand in South Africa, Bezwoda put women into complete remission, first with a high-dose chemotherapy regimen, followed by bone marrow transplants. He presented his scientific studies at the American Society of Clinical Oncology’s meetings and published in major journals — offering results that seemed too good to be true. Trouble was, they were. The results were fabricated, and Bezwoda breached the most basic points of medical ethics, using poor, barely literate Black women in a newly apartheid-free South Africa as his guinea pigs.
Women pressured their insurance companies to pay for this new treatment.
Dr. Emil Frei, in the early 1980s, first suggested high-dose chemotherapy followed by a bone marrow transplant as a treatment for breast cancer. At the Fred Hutchinson Cancer Research Center, Dr. E. Donnall Thomas had already starting proving that when a patient’s cancer-free blood stem cells were removed and then infused after with more chemotherapy — called an autologous bone marrow transplant — he could achieve remission in some blood cancer patients. In 1990, Thomas was awarded the Nobel Prize in medicine for developing the bone marrow transplant protocols, further cementing the idea that these extreme treatments were how we were going to end cancer.
In Johannesburg, Bezwoda began testing a high-dose chemotherapy regimen, and in May 1992, he reported that 51 percent of his patients achieved complete remission. These results were astounding — much better than U.S. or European doctors were achieving — and became the impetus for high-dose chemotherapy as a more standard treatment for advanced breast cancer. Doctors could push the megadose even further with a bone marrow transplant: bringing a patient to the edge of death with toxic chemicals, then infusing them with stem cells in the hopes of bringing them back to life. The fatal flaw? Chemo kills both unhealthy, cancerous cells and perfectly good cells, leaving patients susceptible to infections and anemia. High-dose chemotherapy can also lead to congestive heart failure and irreversible heart damage, or permanent bone marrow damage. But in a world without a cure, women were desperate for a bit of magic.
Women pressured their insurance companies to pay for this new treatment, even though no study had enough women to prove that the megadose and transplant worked better than regular, lower-dose chemotherapy. Women were afraid of being in a study and not receiving what they thought was a lifesaving transplant. But Bezwoda didn’t seem to have much trouble getting women to enroll in his study. When he presented the results in 1999, he claimed to have 154 women in his trial. This might have been enough of a red flag, but what really stood out was how different his results were from three smaller studies that showed little, if any, difference between the conventional and more extreme treatments. In one of the studies, a third of the women died from complications of the transplant alone.
A team of suspicious oncologists traveled to South Africa to review the patient files and protocols. What they saw behind the wizard’s curtain was poor documentation, missed protocols and lies. In normal clinical trials, patients are randomly assigned to receive either the experimental treatment or the standard one. But for Bezwoda’s studies, investigators couldn’t find records showing that there were patients who didn’t receive the experimental bone marrow transplant, while results from some patients had simply been fabricated.
Even worse, in a desegregating South Africa, Bezwoda had taken advantage of Black women who couldn’t read, many of whom had been treated at a Blacks-only hospital. “He was recruiting patients who did not know what to ask for,” says Dr. Cynthia Farquhar, postgraduate professor of obstetrics and gynecology at the University of Auckland and co-author of False Hope: Bone Marrow Transplantation for Breast Cancer. Most of the women shouldn’t have been enrolled because their cancer wasn’t advanced enough to require aggressive treatment, or they had already had radiation therapy, which excluded them from the study. And even worse, no consent forms were found — meaning there was no evidence that the women agreed to be treated with highly toxic chemotherapy.
So how did he get away with it? Farquhar believes it was because the “university didn’t provide or insist on any oversight.” American medical studies are supposed to be reviewed by the institutional review board of a hospital or university, and today most countries have ethics committees that serve a prospective function, says Joseph Ali, research scholar at the Johns Hopkins Berman Institute of Bioethics and associate faculty at the Johns Hopkins Bloomberg School of Public Health. “They look at research and ethics before the study is conducted — at risks and harms,” he says, noting how patients must be fully informed of their choices. Bezwoda’s protocol was approved by his school’s Committee for Research on Human Subjects, but his trial was not audited.
Whatever Bezwoda’s motivations, his lies harmed many. Across the world, some 30,000 women had put their hope in this new therapy, and an estimated 4,000 to 9,000 of them died from the side effects. Later studies, meanwhile, found that bone marrow transplants for breast cancer didn’t offer better outcomes than the standard treatment.
- Kristina Gaddy Contact Kristina Gaddy