Editor’s note: Some of the links included are Italian language sources
Tomorrow, April 3, Davide Vannoni, Stamina’s founder, will be expected at a court trial where he will have to defend himself against an accusation of fraud for asking 500,000 euro for his research. On March 29, an Italian newspaper reported that a judge firmly refused the request of a family to treat their child affected by a severe disease with Vannoni’s stem cell method. The judge defined Vannoni’s method as “quack” science and on these terms refused to give consent for its use.
For those not familiar with it, the Stamina Foundation was established in 2009 by Davide Vannoni, an expert in persuasive communication, who had reported on several occasions the successful derivation of neurons from adult stem cells of mesenchymal origin. He claimed the protocol to be so versatile that the stem cells could be used to treat a wide range of neurodegenerative diseases. On several occasions, the stem cell community raised its open dissent and questioned Vannoni’s modus operandi. The skepticism of the scientific community arose from several observations, among which:
- There was and still there are no scientific publications or data of any kind that can back up and support Vannoni’s claims; if anything as Dr Michele de Luca stated, “Mesenchymal stem cells are skeletal stem cells. They can only generate cells of the bone, cartilage and fat. So, not only is there no evidence that mesenchymal stem cells could cure all these completely unrelated diseases, but there is not even a reasonable rationale for suggesting such a thing.” (Read full statement here.)
- The facilities used by Vannoni were found not to meet the GMP (Good Manufacturing Practice) standards required by law; and, inspections of stem cell preparations to be administered to patients found traces of dead cells and, more importantly, the purity of those preparations was below the minimal standards required for clinically safe procedures
- To this date there are no official clinical data or statistics to support any claim of full recovery with the Stamina method.
Usually, when at least one of these conditions is not met, clinicians/scientists are prohibited from going any further with their research. This was not the case with Vannoni, who is neither a clinician nor a scientist but was nevertheless able to experiment with his treatments on several patients before hitting the regulatory block. At the very least, the shortcuts used by Vannoni and his team to administer their stem cell treatments to patients were found ethically questionable. The compassionate use of care for those patients left with no other options justifies administering experimental treatments as a last resource. On the other hand there is the abuse of such legislation by unscrupulous health practitioners, who use patients as “lab cavia” to test illegitimate and unsafe therapies. The way the situation has been handled by the Italian government reflects the inadequacy of current policies to protect the dignity of patients while at the same time respecting the work of scientists and clinicians that choose to follow the right path to bring safe therapies to those in needs. Ultimately this case urges governments, or at the very least, the Italian government, to take an active role and reshape those not-so-well-defined boundaries that can be easily, maybe too easily, circumvented at the expense of public health. In a time in which translational medicine is taking its first steps forward, it is imperative to establish policies to prevent ambiguous and dangerous actions such as the one put forward by Vannoni.
In the ensuing trial against Vannoni, possibly the most peculiar turn was the attention the Italian media reserved for Vannoni. For instance, a popular TV show, “le Iene” (Italian for Hyena) implicitly compared Vannoni’s trial to a “ David and Goliath” type of scenario with David-Vannoni fighting against the scientific community (the monster Goliath) to save patients’ lives. I’ve asked myself many times why, despite the obviously dangerous flaws intrinsic to his methodology and the many evidences of the negligence, inefficacy, dangerous and unethical practices under which Vannoni and his team operated, that the public and certain media still think Vannoni is or at least was in the right. Even after the flaws were made public, patients were still allowed to receive his treatments. One of the explanations I gave myself is that maybe what seems obvious to the eye of a scientist is not as clear to the eye of a lay audience, particularly if the facts are not fully disclosed or accessible. Analogies are a great communications tool, with a long history of use — the Greek writer Aesop used them in his stories to talk about virtues and mischiefs of humanity.
This is my personal Aesopian twist to this modern stem cell case.
The hunter and the black bear
Once upon a time, there was a village in the middle of the Ancient Mountains, surrounded by lakes and forests, renowned for its legendary beauty and long history. In recent time, the village had been troubled by the presence of a black bear that nobody had been able to capture and whose lethal attacks were causing severe damage to its inhabitants. Its brutal consequences could be seen on the faces and bodies of those who were lucky enough to survive the bear’s attacks. Expert hunters were called in to implement the most advanced operations to capture the bear, but their progress wasn’t fast enough. And because they kept their practices a secret, the villagers did not understand their methods and only saw their delays as failure.
The forest, once a privileged source of food, had now become a dangerous and unsafe place. Families started to ration their own supplies and when that wasn’t enough, stealing from each other became a habit. Among the population there were mixed feelings of rebellion, fear and an urge to do something about it. Van, the youngest son of a farmer, bore the signs of the bear’s violence on his face. The brutal force of the wild beast left him with half his face paralyzed. Only time and determination enabled him to partially recover from that encounter, but the physical and emotional pain of those scars remained a vivid presence. People were scared of Van now and some even made fun of his weird and wicked way of smiling, turning half of his lip up in an intermittent and uncontrollable tremor. Moved by his own personal vendetta against the bear, Van started developing his own hunting strategies. With the help of some friends, he was able to gather all the necessary tools and resources for a hunting expedition. He was determined to bring justice to all the victims, who, like him, had gone through such pain.
One morning Van set out for the forest, having decided it was a good idea to first practice with smaller animals. After spotting a rabbit with his binoculars, he positioned himself against the wind so the animal couldn’t smell his fear, loaded his gun, set the gun on his shoulder, aimed, fired — and missed. After a few trials, he managed to bring down the rabbit. Van was so happy with his progress that he proudly patted himself on the back. He decided to cook the meat. But after one bite, he quickly realized it wasn’t as good as the one his father used to prepare for him and the family. He blamed the animal. Too skinny, not fatty enough to give out good meat. He didn’t know that he had used the wrong bullet. He didn’t know that there were different types of bullets: those built to destroy from the inside-out and those built to inflict minimal damage to preserve its flesh intact. But how could he know that? After all, Van wasn’t a hunter. He had never been interested in that stuff while growing up. He liked playing with words and telling stories. To him, all bullets were the same — same colour, same shape, same sound in the air and same goal. Simple as that.
Finally after days of hunting and observing the bear, Van decided it was time. He was feeling confident. His aim got better and better, his movements in the forest were quicker, his position was steady and not trembling anymore. After spotting the animal from a secure distance, he once again repeated those now familiar moves. He loaded his gun. He aimed. He fired. The sound of the massive body collapsing on the ground resonated through the forest. He had no words for what had just happened. Buoyed by his success, he questioned why it had taken so long for the experts to figure out something so easy. After all, if he managed to do it, how hard could it be? He thought that in reality those hunters never tried hard enough or had no real interest and motivation to capture the bear.
A few villagers happened to be in the proximity and quickly ran toward Van, who proudly and triumphantly told them what he had just accomplished. After returning to the village, the news quickly spread that the bear had been killed by a single gunshot fired with a common hunting rifle. The experts’ skepticism was at the roof. It was just not possible. A gun of that size, with that power and with a bullet of that dimension could never kill such a big animal. It was just ridiculous. They met with Van and asked him to provide concrete proof of his action. Van explained his strategy, and the more details he added to his story, the more convinced the experts became that he had not indeed killed the bear. Van couldn’t stand to be made fun of by a few of his jealous colleagues. By now he had rightfully re-qualified himself as an expert hunter. He called back those villagers that had been in the forest with him the day he killed the bear. They confirmed what they saw: the great beast, lying breathlessly on the ground. More importantly for the people of the village, the bear’s attacks had stopped. What other proof could the experts want?
But in all the excitement that surrounded Van’s success, he and the villagers had forgotten the number one rule, essential to all hunters, even the least trained one: retrieve the body. When they returned to the forest, the body was gone. This essential fact check – was the bear actually dead? – didn’t seem that crucial to Van at that time or to the people, who just wanted to believe in Van’s words. After all, he was damn good at words. Then, the attacks came back. At first people didn’t notice it as the hype over Van’s victory was still high, but to the experts’ eyes the presence of the bear didn’t go unnoticed. A few days later, the village was infested by termites. Fortunately the situation was kept under control with the help of specialists that came to provide the necessary help. The ants had been abruptly awakened by a small fragment of one of Van’s bullets in his attempt to kill the bear. The hunters explained that they knew about the presence of termites in the forest and they had been mapping their nests so that they could avoid hitting them while shooting for the bear.
Days went by. The hunters kept relentlessly doing what they were good at: looking for the bear. However, Van’s case had taught them a lesson. They decided it was time to get better at words and started mingled in with the other villagers in order to teach them basic rules of hunting. They hoped people could become more familiar with their world and work so that mistakes like Van’s would never happen again. The hunters explained that different conditions need to be in place for a shot to be successful. To be equipped with the right gun and the right bullets are just minimal requirements. Knowing the bear’s habitat, the forest, is equally as important. They explained that shooting a bear has long-term repercussions that need to be thought of in advance so that they can be kept under control after. And of course, the more one performs the better s/he becomes. A professional hunter is as guided by instincts as by knowledge. Ultimately, collective efforts, understanding, and trial and error are what it takes to bring down a bear to its feet.
Latest posts by Alessandra Pasut (see all)
- The Hunter and the Bear: Italy’s Stamina and Vannoni, as Aesop would have told it - April 2, 2014
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- How value-free is stem cell research? Lessons (learned) from quantum mechanics and atomic fission - October 15, 2013