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BMJ No 7128 Volume 316 News Saturday 31 January 1998 Italy starts trials for controversial cancer treatment
A controversial cancer treatment will be given experimentally to 2,600 patients with cancer in 21 hospitals around Italy after massive pressure from patients and the media. The treatment - based on a cocktail of drugs, including somatostatin and melatonin - has been developed by Professor Luigi Di Bella. Professor Di Bella, aged 86, formerly held a temporary position as professor of physiology at the University of Modena. He has presented his protocol at a few meetings but has not published his research in a peer reviewed journal. Professor Di Bella says that he has been using the approach for more than 25 years and it is effective against all cancers without any side effects. He has never given any figures, but one of his assistants said that the treatment is effective in about 90% of cases. Patients and the media have been pressing over the past year for the treatment to be prescribed and fully reimbursed by health authorities. The health ministry had forbidden doctors to prescribe the treatment, but last December a judge from a small town in Puglia ordered the local hospital to provide the treatment. Two regional health authorities, in Puglia and Lombardy, have now decided to pay for the treatment. Bowing to public demands, the health minister, Rosy Bindi, has now been forced to establish a commission of 22 experts to look into the treatment, which has been called MDB (multitherapy Di Bella). The commission will be chaired by Professor Umberto Veronesi, the former director of the National Tumour Institute in Milan, and Professor Lorenzo Tomatis, who for many years was the director of the International Agency for Research on Cancer, based in Lyons, France. Nine studies involving about 600 patients have now been quickly planned to test MDB on various cancers, including lung, breast, pancreatic, colorectal, neck, and head, as well as on chronic lymphoid leukaemia, non-Hodgkin's lymphoma, and postoperative glioblastoma. Another group of about 2,000 patients will enter a surveillance programme while receiving MDB under controlled conditions. Professor Di Bella said: "I have great expectations for the patients. Things will get better both for the patients' suffering and for their life expectancy." The studies are expected to begin early in February. Professor Veronesi announced that for some tumours the first results will be available in two months, but several experts are convinced that the estimate is unrealistic. Before the trials begin, the national bioethics committee will be asked to give its advice. The latest moves are the result of increasing public pressure. Last May, when rumours about this "miracle cure" started to spread, the health ministry said that it had not received any new scientific evidence to confirm the claims. Two reports, in February 1996 from the National Oncology Commission and in January 1997 from the Pharmacology Commission, had concluded that there was no scientific evidence to support the use of this treatment. In July, however, Professor Di Bella received a lot of publicity after a radio broadcast in which he claimed that he had treated more than 10,000 patients in the previous 25 years. The health ministry then asked to be provided with scientific data or at least the clinical records of the patients he claimed to have cured. In December millions of Italians watched a television programme in which Professor Di Bella and his assistants accused the "academic baronies" of boycotting his discoveries. Fabio Turone
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