The Stamina Foundation in Italy has provided a phony stem cell treatment since 2006, claiming that it can cure a variety of neurodegenerative disease, including Parkinson’s, Alzheimer’s and rare genetic conditions in children. Finally, after a four-year investigation, a public prosecutor has issued an indictment against Davide Vannoni, the president of the foundation. It accuses 19 prominent public health officials and doctors of defrauding the public. If Italy wants to maintain its standing as a serious member of the scientific community, it has to protect participants of clinical trials and reform the way public funds are allocated.
The basis for Vannoni’s so-called cure is the transformation of certain stem cells from a patient’s bone marrow into brand new nerve cells and injecting them. Unfortunately, these types of stem cells are known to be limited to differentiation into bone, fat or cartilage cells. The International Society for Stem Cell Research said there is not “compelling evidence from clinical trials that such cells provide benefit to patients with neurological conditions.” Yet Vannoni has asked vulnerable adults and children to pay expensive sums for the treatment. Perhaps the most insane fact about the scheme is that Vannoni has a doctorate in philosophy and was previously a psychology professor — he has no background in cell biology. His success stems from support by the Italian media that has allowed him to connect with patients who have incurable diseases and no other therapeutic options.
There has been a steady stream of criticism toward the Stamina treatment from within Italy, but it has consistently been drowned by public support. After regulatory agencies shut down Stamina in 2012 due to safety issues, patients and their family members protested loudly. This pressure convinced the Italian Parliament to provide $3.9 million for a clinical trial and allow the unsafe treatment to continue. A panel of scientists convened to determine the trial design for the government-funded study and found that there was no scientific foundation to Stamina’s proposed methods — they involve unsafe cell cultures, inaccurate testing and could not feasibly work. Furthermore, parts of the protocol were found to be copied directly from Wikipedia.
Ultimately, Vannoni appealed the rejection in court. The court ruled in his favor on the basis that the panel of experts was biased because they had previously vocalized objections to the protocol. A second, hopefully unbiased, panel has convened, but the threat of a dangerous clinical trial still looms. The inability of the Italian government to act quickly and decisively is creating false hope among those who believe the treatment will cure them. Italy’s failure to protect its citizens serves as an important reminder of the occasional benefits of the United States’ seemingly excessive bureaucracy.
A version of this article appeared in the Wednesday, April 30 print edition. Tess Woosley is a staff columnist. Scientific Society is published every Wednesday. Email her at [email protected]