Fraudulent cell therapy an objective ethics problem in biomedicine

One major ethical problem in the field of cell therapy is the fraud that can be committed by proposing the use of treatments that have not been proven to be clinically effective. This fraud can be especially serious when attempts are made to apply the therapy to diseases that are difficult or impossible to treat using conventional techniques, as patients with these types of conditions are willing to undergo any type of therapy. Many of these fraudulent practices have occurred in countries where there is no strict healthcare control, but they have also been reported in developed countries. One such case in Italy has now been published in Nature (510; 333-335,2014).

The italian case

Two Italian experts in cell therapy research have denounced the Stamina Foundation, which apparently not only offers therapies that have not been properly tested, but is also receiving large amounts of financial aid from the Italian Government for carrying out their therapeutic projects.

The Stamina Foundation is led by Davide Vannoni, who without any specific medical training, has been offering cell treatments for various diseases such as Parkinson’s, muscular dystrophies and spinal cord atrophies since 2011, although the center’s methods have never been published in accredited scientific journals. The Foundation has had a troubled history since then, with approval and financial support from some health authorities on one hand, but protests from medical professionals and institutions on the other. In April 2014, the Italian judiciary accused the Stamina Foundation of medical fraud and the professionals who worked there of criminal conspiracy.

 European Court of Human Rights issued a statement

The accused defended themselves on the grounds that they did their job under the aegis of so-called “compassionate use”, which permits some not well-tested methods to be applied in very ill patients who do not respond to standard treatments, provided that they agree to receive them. However, on 28 May 2014, the European Court of Human Rights issued a statement saying that “compassionate use” therapies must also be subject to medical evidence, i.e. they cannot be used if they have not been sufficiently tested. This has led the Italian Senate to study the matter, so these practices will likely be prohibited in Italy very soon. The Stamina Foundation is, therefore, rerouting its activities to other countries, especially Switzerland and Cape Verde.