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Human-rights court rules that evidence must support compassionate therapy

Patients do not have an automatic right to a compassionate therapy for which there is no scientific evidence of efficacy, according to a landmark ruling of the European Court of Human Rights in Strasbourg, France.

The 28 May ruling referred to the case of Nivio Durisotto, whose daughter has a degenerative brain disease. He wished her to be treated with a controversial stem-cell-based therapy offered by the Stamina Foundation, based in Brescia, Italy.

But more generally, it will guide any judge facing requests from desperate patients for access to unproved therapies promoted from outside the regulated medical sector.

The judgement is yet another blow for the Stamina Foundation, whose president, Davide Vannoni, is now facing charges of fraudulently obtaining public money to support his therapy.

The Italian Medicines Agency had closed down the Stamina operations in August 2012 on safety grounds (see ‘Leaked files slam stem-cell therapy‘). In March 2013, the government issued a decree allowing patients to continue Stamina treatment if they had already begun.

Then on 11 September 2013, an expert committee appointed by the health ministry to examine the Stamina method concluded that there was no evidence to indicate that it might be efficacious (see ‘Advisers declare Italian stem-cell therapy ‘unscientific’ ‘). The committee further warned that it could be dangerous.

With encouragement from Vannoni, some patients appealed to courts for the right to treatment with the Stamina method. Some judges ruled that the treatment should be given on compassionate grounds, while others — including the judge in the Durisotto case — ruled that compassionate therapy was not justified because there was no scientific evidence of efficacy.

Durisotto brought his appeal to the European Court of Human Rights on 28 September 2013, a month after losing his case in Italy.

The European Court dismissed Durisotto’s claim, saying that the Italian court’s ruling had “pursued the legitimate aim of protecting health and was proportionate to that aim”. It further said that the Italian court’s decision had been “properly reasoned and was not arbitrary”, and that “the therapeutic value of the Stamina method had, to date, not yet been proven scientifically”. Because the case had been appropriately reasoned, it said, Durisotto’s daughter had not been discriminated against — even if some other national courts had allowed the therapy for similar medical conditions.

Munich-based patent lawyer Clara Sattler de Sousa e Brito, an expert in biomedical laws, says that this “clear ruling that scientific proof is necessary will help avoid the use of unproven therapies for so-called compassionate purposes in the future”.




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    Sergio Stagnaro said:

    Such a decision is logically invalid. In fact, where is the scientific evidence of those therapies which have failed to prevent the CVD, T2DM, and cancer growing epidemics?

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