“I give my word: the 3 million that had been allocated for the Stamina trial will go on research on rare diseases. I intend to keep my word because the saddest part of this story is that there are many desperate families who have clung to the hope of treatment ". It was October a year ago and the minister Lorenzin thus announced the definitive stop to the Stamina trial. Click Thu.
After the disappointment of the 36 patients who had seen their treatment stopped at the Spedali Civili in Brescia, after two years of hopes, of proven benefits, of legal costs, after the seizure of cells and a law (Balduzzi) reduced to shreds, those remained three million public money, already allocated. Then, in the fall of a year ago, the new beautiful promise. "I want to help rare patients and make sure, through local services, that they also assist these better families"Proclaimed the minister.
How it went, however, you can read it Thu. Money already has a recipient, without a public tender.
A code of the maxi-amendment on stability, hidden among other six hundred and just approved by the Senate, diverts the three million in favor of "a phase II clinical trial based on the transplantation of human brain stem cells in patients with ALS, amyotrophic lateral sclerosis". Namely the experimentation started by Angelo Vescovi to the Relief of Suffering house in San Giovanni Rotondo. Brain cells from dead fetuses are used ("they are the neurons of fetuses who have died from natural causes, we take them with the consent of their parents", the same Bishops explained to us three years ago).
The point is that nothing is known about this alleged therapy, because, at the moment, only phase one has ended, the one that excludes the harmfulness of the treatments. And we have always heard, both from Silvio Garattini on behalf of Aifa and from the Minister of Health, "that the burden of proof lies with those who offer therapy".
How come we pay the burden of proof this time?
And based on what the senator Emilia De Biasi asked by Roberta Villa declares that "the measure approved by the Budget Commission is, from a legal point of view, perfectly legitimate"? What laws does De Biasi refer to?
Above all, why has an exclusive chosen person been discovered and has there not been a comparison between multiple therapies and multiple rare diseases?
Ps. to test Stamina, Parliament voted an ad hoc law, given that the 36 patients had already been in treatment for two years and their records contain evidence of the improvements found. Phase I and Phase II passed. And respected democracy.
Not only. The effect of mesenchymal stem cells on Sma1 patients was well highlighted in the work conducted by John Bach e Marcello Villanova. Click here.
Moral: three million euro will go to a phase I research that does not even contain the prerequisites for hope for a therapy while all the good things have happened, in two years, on rare patients, alive and well at the time, including the study , has been buried. Amen.