Controversy about a claimed "miracle" cure for cancer showed no sign of abating in Italy yesterday despite official test results indicating that not a single patient had responded to the treatment.
Dr Luigi Di Bella, the physician who devised the supposed cure, last night accused authorities of rigging the trials to get the results they wanted. "My method has not been tested. My drugs have not been used," he said.
The "Di Bella cure" has been the subject of national debate since Italy's drugs safety board refused to approve it last August. Several judges ordered their local health authorities to make the treatment available free of charge; tens of thousands of people joined demonstrations in support of patients' right to choose; and their cause was taken up by the far-right National Alliance.
As the news of the treatment spread, Dr Di Bella's home at Modena in the north of Italy was besieged by cancer sufferers and their relatives seeking a prescription.
The treatment, which involves a cocktail of drugs and vitamins, had long been available to private patients but was costly.
Six months ago, after a ruling from the constitutional court, the government reluctantly began subsidising the treatment's key component.
But according to Prof Gordon McVie, head of the Cancer Research Campaign and one of several foreign medical experts invited to observe the trials, the "cure" is not merely ineffective but harmful.
"Of the 136 patients in the trials, over 100 are dead or the tumour has progressed," he said. "A few patients are still stable, but there is no measurable response in any of the patients at all after two months of treatment. This is the usual form of test for a new drug."
He added that the Di Bella cocktail had proved to be toxic, which he had not expected.
"There was a lot of vomiting, weepiness and somnolence (drowsiness). Some had abdominal pain and diarrhoea. That is fairly disturbing. It is not likely to have been entirely disease-related. Advanced cancer causes problems, but I suspect a lot of this was not caused by the disease." The government said its tests had shown that 49 per cent had suffered side effects. In three cases out of five, the side effects were serious.