Ethics committee told that 'foundation had stem-cell patent'
Hospital official tells Senate 'we trusted the documentation'18 February, 19:16
"We trusted the documentation provided," chairman of the Spedali di Brescia ethics committee, Francesco De Ferrari, told the Senate. He added that the Italian State Pharmaceuticals Agency (AIFA) had sent a letter to the hospital in August 2011 saying that it had no objections to the treatment. The use of this particular stem-cell treatment has been at the center of controversy in Italy.
Stamina therapy grabbed headlines after desperate parents staged street protests to demand the treatment and forced the government to re-assess its use.
De Ferrari said his committee did not authorize the treatment until it received the AIFA letter. He noted that in early July 2011, the committee had rejected the initial request from the public hospital. Another member of the ethics committee, Carmen Terraroli, added that there had been no adverse effects to the treatment in the first twelve patients treated at the Brescia hospital, a result in line with "numerous other scientific studies on stem cell treatment". Italy's Minister of Health Beatrice Lorenzin announced in October that the Stamina Foundation - the nonprofit foundation that developed the treatment - would not be allowed to test it on humans.
She also stripped the foundation of its non-profit status after a study found its treatment was "ignorant of stem-cell biology".
The head of the foundation, Davide Vannoni, a former psychology lecturer, was indicted earlier this month for alleged attempted fraud against the Piedmont Region. The Stamina Foundation had asked for 500,000 euros worth of funding to develop a stem-cell laboratory, a request prosecutors argue was fraudulent because the efficacy of the treatment has been "completely disproved".
The Stamina treatment involves extracting bone-marrow stem cells from a patient, turning them into neurons by exposing them to retinoic acid for two hours, and injecting them back into the patient.
Supporters of the therapy thought it could be a cure for fatal degenerative nerve diseases such as spinal muscular atrophy, while detractors said it was devoid of scientific merit.
A panel of experts appointed by Italy's health ministry said last month it found the therapy seriously lacking in both premise and practice.
Their report cited "serious imperfections and omissions in the Stamina protocol, including conceptual errors and an apparent ignorance of stem-cell biology".
"Faced with the interpretation AIFA, which held that the Spedali di Brescia hospital had made a mistake, and the regional administrative court (TAR) request for our opinion, the committee decided it did not have the right to decide when the judiciary held one opinion and the healthcare authority another," said De Ferrari at the day's Senate hearing. On May 15, 2012, the Italian pharmaceuticals agency suspended the treatment and since then "we have not expressed any opinion, not even under court order".