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The Italian Ministry of Health, forced by public pressure to conduct clinical trials on the controversial ‘Di Bella’ cancer treatment, announced last week that patients with the types of cancer tested in the trials will no longer be reimbursed for such treatment.

This follows the news that the trials have shown the therapy to be of no clinical value. None of the 134 patients in four clinical protocols showed any indication of remission during three months of treatment, and three-quarters of them have died.

But support for the therapy is still being voiced from many quarters, most strongly from right-wing politicians hoping to benefit politically from its popular backing.

The therapy, designed by physician Luigi Di Bella, is a cocktail of natural products and the expensive drug somatostatin, sometimes also with a low dose of the chemotherapeutic agent cyclophosphamide. Di Bella, now in his mid-80s, claims to have cured thousands of patients in the past couple of decades (see Nature 391, 217; 1998).

Controversy arose when his many followers began to demand that the government pay for the treatment, which costs up to US$6,500 per month. The health ministry initially refused even to conduct clinical trials with the therapy — a prerequisite for reimbursable drugs — because of the lack of a scientific basis for its effectiveness.

When the strength of public support for Di Bella forced the ministry's hand earlier this year, minister Rosy Bindi approved ten tightly designed multicentre trials in different types of cancer.

Di Bella and his supporters, known as Di Bellists, have refused to accept that the therapy does not work, despite the fact that another trial conducted by the Di Bella-friendly government of Lombardia, whose results were announced a few weeks ago, had proved similarly negative.

Di Bella formally approved the protocols of the government-sponsored trials before they began. But after the results of the first four protocols had been published — the remaining six will be completed by October — he said he had not read the documents before he signed them. He also insists that the protocols do not correspond exactly to his therapy, and that the trials are therefore not valid.

The local judge from Lecce in Puglia, who first ordered that the state pay for a patient to be treated with Di Bella therapy, has set up his own inquiry into the validity of the trials, and has ordered Giuseppe Benegiano, director of the Higher Institute of Public Health in Rome, which is coordinating the trials, to testify this week.

Benegiano, who has been inundated with calls from people claiming that the trials were designed only to “count the dead”, has published a request for those cancer sufferers who claim to have been cured to come forward for assessment, “so that we can also count the living”.

The issue is receiving close attention in top political circles. Prime minister Romano Prodi has publicly welcomed the “clarity” of the results of the trials, while his political opponents in right-wing parties such as Forza Italia, hoping to gain populist support, have accused the centre-left government of wanting to discredit Di Bella to avoid having to pay for the treatment.

Benegiano says he hopes that public opinion, which has been staunchly behind Di Bella, will be swayed by the mounting evidence — including trials conducted by Di Bellists themselves — that the treatment does not work. “But it will take some time, because the Di Bellists seem incapable of taking no for an answer,” he says.