By Catherine Hornby
ROME (Reuters) - Scientists have criticized an Italian government decree allowing a group of terminally-ill patients to continue using an unproven stem cell treatment, saying such therapies may cause harm and risk exploiting desperate people.
The treatment, created by the privately-owned Stamina Foundation, was banned by Italian medicines regulator AIFA last year after it inspected their laboratories, leading to a series of legal challenges by families of patients.
In early March, Health Minister Renato Balduzzi allowed a terminally ill child to continue using the Stamina treatment after hearing the emotional pleas of her parents.
The Health Ministry then issued an official decree on March 21 allowing 32 patients, mainly children, already using the treatment to continue it.
Scientists from around Europe released a statement on Thursday criticizing the decree, warning that Balduzzi was "riding roughshod over existing European licensing criteria", failing to protect patients from exploitation and ignoring the need for sound evidence that therapies are effective.
"These unproven and ill-prepared stem cell therapies, for which there is no scientific basis, will do nothing for patients and their families except make them poorer," said Charles French-Constant from the University of Edinburgh's Center for Regenerative Medicine.
"DANGEROUS PRECEDENT"
Advocates of the therapy say strict regulations work in favor of big drug companies with their portfolio of blockbuster treatments, reducing the pool of potential competitors. But scientists said Stamina's treatment was unproven and risky.
"There is no rationale for this and no evidence that these procedures are not dangerous for patients," said Professor Michele De Luca of the University of Modena.
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Scientists criticize Italy for allowing unproven stem cell therapy