Three elderly women in Florida have been blinded by an unproven treatment, as a reminder of how dangerous stem cell therapies can be. The New England Journal of Medicine reports that the women signed up for a purported clinical trial in 2015 – for which they had to pay US$5,000. Within a week, they experienced a variety of complications, including vision loss, detached retinas and haemorrhage. Before the surgery, the vision in their eyes ranged from 20/30 to 20/200. They are now blind.
The article is a "call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research," said Jeffrey Goldberg, of Stanford University School of Medicine and a co-author.
"There's a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer, but in this case these women participated in a clinical enterprise that was off-the-charts dangerous," said Thomas Albini, another co-author.
At the clinic, U.S. Stem Cell Inc, fat cells from the patients’ abdomens were processed to obtain stem cells which were injected into their eyes. Patients reported that the entire process took less than an hour. The patients had both eyes treated at once -- even though most doctors would opt for a conservative approach to observe how the first eye responds.
"There is a lot of very well-founded evidence for the positive potential of stem therapy for many human diseases, but there's no excuse for not designing a trial properly and basing it on preclinical research," Goldberg said.
The "trial" lacked nearly all of the components of a properly designed clinical trial, including a hypothesis based on laboratory experiments, assignment of a control group and treatment group, collection of data, masking of clinical and patient groups, and plans for follow-up, Goldberg and Albini said. "There was a whole list of egregious things," Albini said.
BioEdge: When stem cell treatments go wrong, they really go wrong
One of the star exhibits in the Royal College of Surgeons' Hunterian Museum of anatomy in London is the skeleton of Charles Byrne, an 18th Century Irishman who was about 8 feet tall. However, the museum is to close in May for renovations and there are calls to use the opportunity to remove or bury the remains. Does this make sense?
A celebrity in his day, Byrne died in 1783 of ill health and drink in London. He knew that John Hunter wanted to dissect him after his death, so he directed his friends to sink his body in a lead-lined casket in the English Channel. Alas, Hunter succeeded in stealing the body anyway and it eventually turned up in a display case.
Similar events darken the history of the Australian state of Tasmania. The last full-blood Aboriginal Tasmanian, William Lanne, died in 1869. Although the story is murky, it appears that before his funeral the Surgeon-General of the colony, William Crowther, stole his head for “scientific study” and someone else removed his hands and feet. There is no record of scientific studies. Crowther went on to become premier, and an impressive bronze statue of him was erected in the centre of the city.
The last full-blood Aboriginal woman in Tasmania, Truganini, was terrified that the same thing would happen to her and directed that her body be cremated. Her wishes were ignored and her skeleton ended up in a display in the Hobart Museum. It was finally cremated in 1976.
Nowadays body-snatching would not be tolerated (although the Hunterian Museum still refuses to remove Byrne’s body from display). But the notion that scientific curiosity is its own justification persists. University of Tasmania historian Stefan Petrow points out, that the fate of Lanne and Truganini demonstrate “the hegemony scientific knowledge sought to establish over fundamental human rights such as a decent burial”. Can’t the same thing be said about some aspects of stem cell research?
|NEWS THIS WEEK|
Suite 12A, Level 2 | 5 George St | North Strathfield NSW 2137 | Australia
Phone: +61 2 8005 8605