Scientific Concerns about Claims of Stem Cell "Cures"
The dubious business of selling so-called stem cell "therapies" seems to be gathering momentum, and some scientists are becoming quite alarmed.
One who is vocal on the subject is UC Davis cell biologist Paul Knoepfler, who wrote last week, in reference to a chain of clinics called Stem.MD:
I am extremely concerned about patient safety, the risks to the newly recruited physicians who are newbies to the stem cell world, and the huge risks to the entire stem cell field should there be major negative outcomes from these chains.
There have been fraud convictions in Nevada for selling "hope" that stem cell treatments would cure the chronically ill; exposés by 60 Minutes of phony labs in Ecuador and Mexico that cater to Americans; scandals in the Philippines (where the government is at least trying to regulate the industry); legal and financial difficulties for South Korea's leading stem-cell company; and the continuing saga of the Texas-based Celltex, which seems to be treating patients in Mexico.
But Italy tops them all.
There has been something of a mania in Italy for legalizing stem-cell therapies, on a scale that is reminiscent of South Korea at the height of the Hwang Woo-suk frenzy in 2005. Many Italian scientists were horrified by the government's decision last spring to authorize an unproven treatment, which was given to "more than 80 patients, mostly children, for a wide range of conditions, from Parkinson's disease to muscular dystrophy, before the health authorities halted its operations in August 2012."
Nature joined in with some investigative journalism that suggested plagiarism at least and possibly fraud. In the fall, an expert panel concluded that there was no scientific basis for the alleged treatment conducted by the Stamina Foundation, headed by Davide Vannoni. But the enthusiasts fought back and won a court order to reopen the question.
Now Nature has obtained and described the unpublished expert evaluations of the Stamina treatment, documents that it characterizes as "damning." Among other issues, the procedures involved would have been very unlikely to produce the cells claimed, the evaluations say, and even if they did the numbers would be too small to be efficacious. Moreover, there was no screening for pathogens; a proposed process made it likely that any clinical trial would be insufficiently standardized; there were conceptual errors in the clinical rationales; and some sections of the protocol had been copied from Wikipedia. Also, the patients that have been treated are not getting better.
Knoepfler, who runs a stem cell lab and remains a strong supporter of their therapeutic potential, is following this case closely. He comments:
I cannot fathom how Stamina could be good for the patients, including mostly vulnerable children.
Vannoni does have some scientists on his side, notably Camillo Ricordi, who is based in Miami, but he is also becoming controversial. Several leading Italian scientists have resigned from committees and foundations with which Ricordi is associated, because of his support for Vannoni. Moreover, Nature reports with evident concern:
Ricordi backs a controversial proposal that cell therapies should not be regulated as medicines, as US and European regulators insist, but as transplants. He argues that because transplants are not subject to strict regulation, novel stem-cell therapies could be introduced more quickly.
How potentially disastrous. There are already far too many scams being perpetrated on the unwary who are blinded by hope. New national and international regulations are desperately needed. As Dr Christopher Ceneno (an advocate of stem cell therapies, who himself has been the subject of criticism for over-optimism) wrote on Knoepfler's blog last June:
New procedures in medicine that take on a "Wild West" mentality are usually not regulated by some federal agency, but by the civil tort system. This then leads to guidelines that doctors must follow to get insurance and avoid law suits. So in the end there will be "regulation," just not the type we all planned.
Update 1/14/14: Nature has published even more damning evidence about Stamina; and the Oregon Medical Board has suspended a physician for conducting experimental stem cell treatments the board considers an "immediate danger to the public."
Previously on Biopolitical Times: