Oct 06 2014

Italy Smacks Down “Rogue” Stem Cell Clinic

Cases such as this highlight for me the need to have a clear understanding of the actual issues that underlie controversies. With regard to medicine, there is a clear need for a standard of care in order to protect the public from snake oil, charlatans and incompetence.

Promoters of therapies and health products that do not meet a reasonable standard are always distracting from the real issue by trying to make it about something else – freedom, conspiracies, East vs West, or philosophy. This unfortunately works, at least with some people.

However, if you ask people – do you think medical treatments should be supported by sound science, most will say yes. Do you think the government should protect the public from harmful or useless products with deceptive claims, most think this is already the case.

In a recent case in Italy, the conflict between standards and deception have once again played out, this time with a clear outcome. The controversy involves a stem cell clinic called the Stamina Foundation. The president, Davide Vannoni, is a psychologist at the University of Udine who does not have expertise in stem cells. He has not published the details of his stem cell therapy, which uses adult derived stem cells harvested from the bone marrow of the patient. He has also not published scientifically rigorous outcomes. When regulations in the EU tightened for stem cell clinics, he moved to a city with more relaxed regulations.

The scientific community, rightfully, had a problem with the Stamina Foundation. Vannoni was essentially claiming to have made a significant advance in stem cell therapy, without transparency of exactly what he was doing, and without providing evidence to support his claims. Yet, he subjects sick patients, many of whom are children with serious diseases, to his treatments.

There really should have been no controversy here – the Stamina Foundation was not adhering to a minimal standard meant to protect the health of the public. Savvy self-promoters, however, know which buttons to push. Also, desperate patients and their families are easy to mobilize for their right to have the hope offered by whatever the snake oil salesman is selling.

And so patients, families, and supporters took to the streets to fight for compassionate use. The sign above says it all – politicians want to “destroy hope.”

The controversy deepened when health minister, Renato Balduzzi, ordered that treatments could continue for terminally ill children. Further, the clinic applied for federal funding of a clinical trial of the treatments. Superficially, this may seem like a good idea. Let’s study the treatment and resolve the controversy.

However, there also needs to be protection for patients in clinical trials. A study has to be ethical. Further, the potential treatment has to be worthy of taking limited funding (and other resources) away from other potential therapies.

So, the new Italian health minister, Beatrice Lorenzin, put together a committee to review the Stamina Foundation and its claims. They concluded in October 2013 that the treatments were not worthy of funding. However, that decision was challenged because some of the committee members had previously expressed negative opinions about the Stamina Foundation. I think this is a pretty thin excuse, since most of the Italian scientific community relevant to the issue expressed concerns about the treatment.

In any case, a new committee was assembled and now they have reached their decision, which is devastating to the Stamina Foundation. Lorenzin ruled that the Stamina Clinic is not eligible for funding and this decision cannot be appealed. The decision was based on the recommendations of the second committee (which, incidentally, agreed with the first committee).

They determined that the Stamina Clinic was not using proper manufacturing standards for stem cells, did not have a proper rationale for treatment, and that they lacked knowledge and expertise in stem cells. Basically – they didn’t know what they were doing, and they weren’t doing it right.

It seems like a pretty clear case of protecting the public from gross incompetence and unsupported claims. Certainly the clinic should not be rewarded for making such claims with a multi-million euro grant. That would be a terrible precedent – any charlatan can make outrageous claims and when challenged get their patients to take to the streets demanding hope from their politicians, and then request millions of dollars to study their treatment to resolve the controversy they just generated. Of course, if you call them on their nonsense, you must be anti-science because you oppose research.


The decision by the Italian health minister, given the public details, seems to be right one. A committee of experts (actually two committees) has determined that the clinic lacks proper transparency, procedure, and expertise to be giving experimental stem cells to dying children. Further, they are trying to exploit their patients, not just for money, but exploit their desperation to manipulate politicians into strong-arming the scientific and medical community into not only supporting their treatment but giving them money to study it.

The pattern is all too common, and has played out in the US many times. Maverick clinics know how to manipulated patients and politicians to evade a basic level of standards.

Such manufactured controversies could always benefit from clarity – the clarity of pointing out that in health care minimal quality standards are absolutely necessary, and when the options are clearly laid out, most people agree with that.

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