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July 31, 1998

ROME JOURNAL

Call It Hope, or Quackery, When Cancer Strikes

By ALESSANDRA STANLEY

ROME -- Dr. Luigi Di Bella, an 85-year-old physiologist in Modena who says he discovered a miracle cancer treatment, has for the last year held center stage in Italy as he fought -- and almost won -- an astonishing battle for legitimacy.

Hailed by some as a savior, derided by others as a dangerous crackpot, Di Bella suffered a setback this week when government tests of his method indicated that it does not work. But those preliminary findings did not just tarnish his credibility. They also shed dramatic light on how human desperation -- and a huge lobbying campaign -- forced the Italian public health system to provide a treatment without any proof of its efficacy.

More than 2,000 cancer patients were permitted to take the Di Bella treatment free of charge before any serious clinical tests had been completed.

"It was not possible to resist the pressure from judges and the media, who declared the treatment valid before it was tested," Rosario Bindi, Italy's minister of health, said Thursday in an interview.

"I was accused of killing hope," she said bitterly. "But there was no scientific evidence to support even the clinical trials. They were forced on us by a social malady that swept this country. Once we allowed the clinical trials, we could not limit it to small numbers."

This week Ms. Bindi's office issued the results of an initial part of the first nationwide test of the treatment. A panel of Italian and foreign doctors concluded that not one of 134 patients showed any improvement after two months of treatment. Seventy-five percent of the patients either grew sicker or died. Forty-nine percent were found to have toxic side-effects from the cocktail of vitamins, drugs and a growth-inhibiting hormone called somatostatin that makes up the treatment.

Di Bella, who says he has cured 10,000 patients with his treatment with the mixture, was unrepentant, insisting that the trials had been rigged by oncologists jealous of his success.

Ms. Bindi initially resisted calls to make the treatment available free of charge, as are more orthodox cancer treatments like chemotherapy. But public pressure was overwhelming. A kind of mass hysteria drove thousands of cancer patients and their families to hold rallies and sit-ins before government buildings and in St. Peter's Square. In a February Vatican address, Pope John Paul II called for "reconciliation" between Di Bella followers and government officials.

"You have no idea what kind of pressure we were under; society was set to explode," said Dino Amadori, president of the Italian Oncological Society, who also took part in the clinical trials. "Our office was getting death threats."

In December a local judge ordered the health authorities in Lecce, a town in Puglia, to administer the Di Bella treatment without charge to a 2-year-old boy with a cancerous brain tumor. The boy died this month, but that case unleashed a number of legal actions. Politicians leaped in, as right-wing opposition parties championed Di Bella and accused the government of costing lives. Local administrations in Puglia and Lombardy independently began sponsoring the treatment.

In February the Health Ministry relented and said it would put 600 patients with breast, colon and other forms of cancer in an intensive clinical study. The number was later reduced to 397. For the duration of the testing, the ministry also said it would permit 2,000 patients with the same cancer diagnoses as those in the clinical study to get the Di Bella treatment free, under observation by the public health service. The mixture, which was costing $350 a day until the government pressed pharmaceutical companies to lower their prices, still costs about $60 a day.

In May the Constitutional Court ruled that by limiting the number of patients who could get the treatment without charge, the government was enforcing economic discrimination. That forced the government to offer the treatment to any cancer patient who requested it, for as long as the clinical trials were being held.

The full conclusions are expected in September or October. But the negative results obtained with the first 134 patients have already led the Health Ministry to pull them off the treatment, as well as those who were getting state-supported treatment for the same protocols and whose symptoms have worsened.

The reputation of Di Bella, a reclusive man with a vast, fanatical following in Italy, has spread across the world. Last June he traveled to Canada to explain his method. But he has long resisted backing his claims with scientifically documented evidence. "They failed to show us any objective evidence that this treatment has efficacy," said Dr. Victor Fornasier, a Canadian pathologist who led a delegation to Modena in March.

Italian health officials justify their actions by saying the additional 2,000 patients they put under observation would have sought out the treatment from any of the dozens of doctors who are followers of Di Bella, paying their own way without any independent supervision.

But by administering the treatment in state-run clinics, however experimentally, the government ran a different ethical risk: giving vulnerable people the impression that it condoned an unproven treatment.

American medical ethics experts, who have watched similar lobbying crusades for alternative cancer treatments like laetrile, were appalled.

"It is grotesquely outrageous," said Barrie Cassileth, an American medical ethics expert and author of "The Alternative Medicine Handbook." "It is malpractice on the part of public health services to offer an untested, unscientific method as a real alternative."

Di Bella alone seems serene. "For me, nothing has changed," he said in an interview Thursday. "I will continue my work. I am guided by truth, and scientific truth doesn't depend on a government decree."




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