Wednesday, July 10, 2013

If Stamina, 5 questions for the Minister of Health - Wired.it

Into The controversy about the method Vannoni continue, after the indictment of Nature and criticism from scientists. That is why we clarity to the Minister Lorenzin

Into “ We want to reassure families that all procedures have been initiated in accordance with the rules on schedule and that the trial will start as soon as possible .” These are the words of a press release from the Ministry of Health , just released, the method discussed Stamina , based sull’infusione of mesenchymal stem cells should treat neurodegenerative diseases. The ministry also announced that the first meeting of the bodies responsible in the trial is scheduled for next Friday, July 12 . No comments on allegations of fraud raised by the scientific journal Nature : currently there would be no demonstration of efficacy for the treatment of diseases of the nervous system with the injection of cells inexplicably transformed in new neurons. The episode is spent a whole week, during which we followed the story through the voices of many of the actors involved, from scientists pointing your feet against the testing those who said they were instead longer available , by the President of Stamina Onlus David Vannoni to the many patients involved and supporters of the method, which continue to draw attention through social networks as well as showing in the Italian squares.

In our opinion it is not and continues to lack a strong voice and clarification on the matter. Why on case Stamina remain many outstanding issues. So we’ve decided to raise the issues that seem compelling to the Minister of Health Beatrice Lorenzin . Here are the questions we sent (accompanied by why say) and to which we hope will soon be answered.

1) The magazine Nature has discredited the method Stamina, accusing David Vannoni of scientific fraud. And Italian and foreign researchers claim there is no scientific evidence that the treatment works. How do you respond to criticism? The trial of three million euro will go on? The British magazine has raised a fuss saying that Vannoni, in a patent application in which years ago had the basic method of Stamina, copied and falsified data. And this does not only discuss the conduct of the same Vannoni, but also the very existence of a method referred t o in the moment nothing has yet been made official. We want to understand what will count once confirmed, this accusation, in future decisions of the Ministry in respect of the testing.

2) The method Stamina will be the subject of a clinical trial. On what basis the Ministry of Health will launch? It is in possession of evidence that suggest the efficacy and especially the non-toxicity? Vannoni and other promulgators method Stamina have never shared with the national and international scientific community or the procedures by which cells are treated before infusions, or clinical outcomes based on objective criteria and recognized that they can show whether they work in patients or even have adverse effects. Due to the absence of such information, we wonder about what the Ministry of Health has referred to initiating the clinical trial.

3) The President of Stamina would have to be delivered in early July the protocols on the method, but t he Ministry of Health is still waiting. When they arrive? What are the official reasons for the delay? Intends to impose an ultimatum? The protocol is not a mere formality, but all the information that anyone found responsible for an experimental therapy must submit to the Ministry of Health to make sure that this is verifiable both in the method, that efficacy, which in toxicity. In the case of Stamina, was to be presented by Vannoni at least a week ago, but is still quite firm. Consequently, the start of experimentation is slipping from day to day until a later date. Why and as long as we remain in this situation?

4) Vannoni calls into question the objectivity of the assessment method Stamina in the experimentation and advancing claims of more guarantees. What is your response? Intends to take into account the demands of Vannoni? Vannoni has never hidden to believe that a conspiracy of scientists envious and pharmaceutical lobbies want to hinder its care. Specifically the trial, does not agree on the names of the experts who have been called to form the evaluation committee, as some of these have already expressed concerns in the past about the case. It calls for days from the Ministry of Health because it provides the best guarantees of objectivity (just read the conclusion of the post dating back to July 3).

5) There are institutions that continue to authorize the administration of mesenchymal stem cells to patients as a “compassionate care” . She has expressed opposition to these decisions. What kind of action is processing? Question rising from the power of the judges, which in fact may allow the use of such treatment, if required by patients in public facilities.

(Credits for the photo: Getty)

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