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Study Focuses on Alternative Cancer Treatment

United Press International

June 09, 2000

ARLINGTON, VA. June 9 (UPI) Using a century-old technique, a New York physician claims to have brought scores of cancer patients into remission, by orally administering pancreatic enzymes derived from pigs.

      Nicholas Gonzales, M.D., reported his findings yesterday at a national alternative cancer treatment conference here, Comprehensive Cancer Care 2000.

      Although many novel cancer therapies were introduced at the conference, Gonzales' is receiving unique attention from the government: A large clinical trial of the therapy for treatment of pancreatic cancer patients is being undertaken at New York City's Columbia-Presbyterian Medical Center, funded by a $1.4 million dollar grant from the National Institutes of Health's Center for Complementary and Alternative Medicine.

      "It is the first time an alternative treatment has gotten this level of official support, but we like to think it is just the beginning," says Dr. James Gordon, M.D., director of the Center for Mind-Body Medicine, a co-sponsor of the conference.

      In the early 1980s, while still a medical student at Cornell, Nicholas Gonzales began investigating a cancer treatment developed around 1900 by John Beard, a Scottish biologist and researcher. Beard believed that pancreatic enzymes, essential for digestive function, were also the body's best defense against cancer.

      Beard, trained as an embryologist, had learned that the placenta acted aggressively, almost like a tumor invading the body, until the very day an embryo's pancreas became active. He speculated that pancreatic enzymes might be effective against tumors.

      He extracted pancreatic enzymes from a pig -- chosen because a pig's pancreatic enzymes are most like humans --and injected them into mice, in which tumors had been artificially induced. The tumors regressed.

      As early as 1905 physicians reported successfully using injections of pork pancreatic enzymes to treat even advanced cancers of many kinds.

      "There are documented remissions in leading medical journals of that time," says Nicholas Gonzales. "But the introduction of radiation therapy in that era quickly came to dominate the emerging field of cancer treatment."

      Nonetheless, some physicians in Europe and the United States continued to administer the pancreatic enzymes to cancer patients. In the 1960s, an oral form of the enzyme treatment was developed.

      "It was easier to use," says Gonzales," but probably less potent."

      Such oral therapy was often supplemented with strict dietary regimens to strengthen and detoxify the body. Dr. Gonzales' own protocol combines the oral pills with a strict diet and an additional controversial feature: daily coffee enemas.

      Since 1987 Gonzales has treated nearly 1,000 cancer patients from the United States and around the world at his office in Manhattan. Most of them have failed chemotherapy, radiation or surgery.

      Gonzales has reported remissions among some hundred of his patients and of and long-term survival in many more, years after their prognosis had been considered hopeless.

      He continues to get more patients than he can treat, although the therapy is demanding, involving as many as 150 pills a day, about half pancreatic enzyme pills and half nutritional supplements.

      In 1993 he was invited to present a series of his cases at the National Cancer Institute. An administrator suggested Gonzales design a small pilot study, involving patients with pancreatic cancer, generally regarded as one of the worst forms of cancer and resistant to traditional therapy.

      "The idea was that if you could show any benefit at all in those patients, that might really tell you something meaningful," Gonzales says.

      Gonzales conducted the study from January of 1994 to January of 1999. It was published last year in the journal ``Nutrition and Cancer.'' The study included 11 patients with pancreatic cancer, eight of whom had the most advanced form of the disease. All of the participants were patients for whom curative surgery was no longer considered a possibility.

      Of the 11 patients, nine lived for one year, five for two years, four for three years, two for four years, and one patient lived five years. The mean survival time among the patients was seventeen months.

      By contrast, Gonzales points to a recent large-scale study of 126 patients on Gemzar, a new chemotherapy drug approved for pancreatic cancer. No patient in that study lived longer than 19 months and the average survival time was five-and-a-half months.

      The study in Nutrition and Cancer caught the attention of researchers at the National Cancer Institute.

      "It was quite impressive and interesting data," says Dr. Jeffrey White, Director of the National Cancer Institute's Office of Cancer Complementary and Intensive Medicine. "The seventeen-month survival time was way out of the range usually expected for patients with that form of cancer and at that stage of disease."

      White cautions that because Dr. Gonzales' treatment is demanding --requiring, for instance, that a patient be able to eat and swallow --the study may have featured atypically healthy patients. Nonetheless, he believes that the study findings called for a larger case controlled study. Such a trial is now getting underway at Columbia-Presbyterian Medical Center in New York City.

      The trial will follow two groups, with 70 to 80 patients in each. One group will receive Dr. Gonzales' treatment therapy while the other -- matched for criteria such as age, stage of disease and weight loss -- will receive standard chemotherapy or radiation. Everyone in the study must be within six weeks of diagnosis and never had had a treatment or surgery designed to cure their disease.

      Investigators will be comparing survival time between the two groups and evaluating "quality of life" issues, such as pain management.

      Patients are being recruited for the study, to be overseen by the National Cancer Institute. The study's primary investigator is Dr. John Chabot, Chief of Oncological Surgery at Columbia-Presbyterian.

      Chabot admits that he only slowly warmed to the idea of the study.

      "When I first heard of Dr. Gonzales' therapy, my reaction was what anyone's would have been: I was skeptical," says Chabot. "However, after reviewing the data Dr. Gonzales generated in his pilot study, I considered whether this might not be a viable treatment."

      Chabot estimates that the study will take three to five years to answer questions about the potential benefits of the Gonzales protocol.

      "If we can demonstrate that there is a real effect," Chabot says, "then we have to take the protocol apart and ask if there is one element in it that really makes the difference. Is there a single underlying mechanism?"

      Nicholas Gonzales himself is convinced that it is the pancreatic enzymes and not thenutritional regimen, which provide the critical anti-cancer component of his treatment.

      "Strictly nutritional cancer therapies have been tried for years, without any really compelling evidence as to their benefits," he says. "Besides, the original researchers, like John Beard, who used the enzymes at the turn of the century, documented cancer remissions -- and they were administering nothing more than the enzymes to patients."

(C) 2000 UPI All Rights Reserved.


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