西亚试剂：The ups and downs of Italy’s struggle with stem-cell-therap

For most of the past two years, we and others (especially stem-cell specialists Paolo Bianco and Michele De Luca) have spoken out against these treatments. We have had to miss grant deadlines and professional meetings to make our case. We have learned to apply our investigational abilities outside our disciplines, and have come to appreciate the skills involved in helping non-scientists to grasp the value of evidence, rigour and risk assessment.

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Elena Cattaneo talks to Alison Abbott about the battle to challenge the Stamina method
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Our most recent victory came on 28 May, with the release of a ruling from the European Court of Human Rights that patients have no right to receive therapies for which there is no scientific evidence. But we are not ready to relax. Earlier this month, Marino Andolina, the Stamina Foundation's vice-president, was appointed acting commissioner of the public hospital in Brescia, in northern Italy, where the foundation still operates; a court gave him the go-ahead to give a child the 'Stamina treatment'.

Desperate patients will always be vulnerable to exploitation. We hope that sharing our experience — and we learned some lessons the hard way — will help other investigators to join the fight against predatory pseudoscience.

Into the fray
We first became aware of Stamina's claims in August 2012. Three months before, inspectors from the Italian Medicines Agency had shut down Stamina's operations at the hospital in Brescia, deeming its cell-preparation methods unsafe. Patient groups responded with lawsuits, demanding that the 'Stamina method' be made available for anyone with a terminal illness and for its costs to be covered by Italy's public health services.

In August 2012, one Italian court ruled that a child with spinal muscular atrophy could receive the treatment. Since then, the majority of the 500 courts that patients turned to decided in favour of the treatment and ordered its administration in the Brescia hospital.

Nature special: Reprogramming
In winter 2012, we and others began alerting patients, politicians and the press — writing articles and giving dozens of interviews every week — to the view that the method lacked both regulatory precedent and scientific rationale and did not qualify for compassionate use.

Together with De Luca and Bianco, we began scrutinizing websites and Facebook pages into the small hours. We found that although Stamina presented itself as a private charitable organization, its address was that of a commercial company, Medestea, which had been fined for misleading advertising for dietary supplements. We began to collect evidence that Vannoni was trying to lobby government officials and members of parliament to have his operations exempted from regulatory oversight and to have national health plans cover untested protocols. We found that Stamina's patent applications had been rejected because the US patent office found they lacked specificity, stating in part that it was unlikely that collected cells could be induced to form desired types under the conditions described. But no one — not the journalists, public-health authorities or hospital physicians — had bothered to dig. We began talking daily with officers in the health unit of the Italian police.

By early 2013, those of us objecting to Stamina were being vilified by Vannoni and by some media outlets as keeping children from life-saving treatments. The evidence, which a small group of us had spent months collecting and distributing, was largely ignored. We knew that there can be no compassion without safety and efficacy, and that we needed to stay vocal, lucid and rational. Most of all, we had to avoid succumbing to the feeling that we had done all that we could be expected to do.

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