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OAM Cancer Workshop A Great Success

AM is the official bimonthly newsletter of the Office of Alternative Medicine (OAM), Office of the Director, National Institutes of Health, Bethesda, MD 20892-9904.

While the rest of the U.S. watched the June D-Day ceremonies televised from Normandy, some 110 persons packed a Bethesda, MD, motel room designed to hold 50. They were there to gain greater insight into the methodologies for testing alternative therapies for cancer.

Organized and chaired by OAM Aron Primack, MD, the knowledgeable faculty of 13 laid out in meticulous detail the required elements for quality studies of alternative cancer therapies.

The full agenda included such topics as patient recruitment and selection, single- and double-blind studies, pitfalls in pathology and radiology, data collection, ways to measure a study endpoint, and the concept of a best case series.

Looking for Success

Mary McCabe, RN, of the National Cancer Institute Division of Cancer Treatment (DCT) introduced the session on best case series. She said DCT, as part of its search for possible new cancer therapies, developed the concept of the best case series in 1991. Under this approach, DCT invites investigators to present their best cases; their best documented success stories. The approach permits DCT to explore possible therapies from a very wide range of both orthodox and alternative research.

Best cases is not a funding program; however, if a therapy presented in this manner seems to merit further investigation, NCI may fund Phase II and, if indicated, Phase III clinical trials.

Three Best Cases

Nicholas J. Gonzalez, MD, a practicing physician in New York City, was invited to present 25 of his best cases; to DCT in July 1993. Dr. Gonzalez claimed to have achieved extraordinary survival rates among patients with pancreatic and liver cancers, two of the most aggressive and swiftly fatal human cancers.

At the June 6 cancer workshop, Dr. Gonzalez followed Ms. McCabe to the lectern and presented three of those 25;best cases; (see p3, this issue).

A report of the June 6 workshop is due later this year. AM

Best Cases of an Enzyme-Based Cancer Therapy

By Nicholas J. Gonzalez, MD, New York, New York

The Gonzalez Protocol has three components: diet, supplementation with nutrients and enzymes, and detoxification. The diets range from a pure vegetarian program to one requiring fatty red meat daily.

The supplement programs include vitamins, minerals, trace elements, and large quantities of pancreatic enzymes, which provide the anti-cancer action. Each cancer patient consumes about 160 capsules daily. Dr. John Beard, a Scottish embryologist, first suggested in 1904 that the pancreas enzymes are the main defense against cancer. In a 1911 monograph, Dr. John Beard The Enzyme Therapy of Cancer, summarized his theory.

Basic science supports this work. In 1965, Leighton King, a researcher at St. Joseph Hospital in Arizona, reported complete prevention of tumors in a test group of C3H mice carrying the Bittner milk factor virus; they received oral pancreatin. The control group had 100 percent tumor occurrence. In a second article, King proposed an immune enhancement effect for ingested pancreatin in an experimental group of Swiss mice.

I suspect the proteolytic proteins have a direct anti-cancer capability, as well as activity mediated via immune enhancement. Whatever the pathway, normal tissues seen completely unaffected. Furthermore, although many scientists believe orally ingested enzymes will be degraded in the gut. The animal work by King and my own experience indicate otherwise.

The third component of The Gonzalez Protocol: detoxification incorporates many techniques, including coffee enemas that are believed to stimulate liver function.

On July 7, 1993, at the NCI I presented 25 histories of my best cases: patients with diagnosed, biopsy-proven cancer who enjoyed either documented regression of disease or long-term survival on their nutritional protocol. Here are three of those 25 cases:

I. F., a 68-year-old woman, underwent a left mastectomy for carcinoma in July 1987; 1 of 7 lymph nodes was found positive. She was initially treated with tamoxifen; but when a CAT scan in September 1988 showed metastatic disease in both lobes of the liver, she was started on CMF chemotherapy (Cytoxan, methotrexate, and 5-fluoracil). After 5 months of treatment, a repeat scan showed enlargement of the lesions, and chemotherapy was discontinued.

F. came to see me in June 1989 and entered the program; 11 months later, a CAT scan showed a 30 percent reduction in her liver tumors. In 1992 another scan showed a 95 percent reduction in her tumors. She continued to do well after 5 years on the program.

II. J., a 50-year-old businesswoman, underwent right breast lumpectomy for carcinoma in November 1986. J. did well until July 1989, when her physician detected a mass in her right breast. A lumpectomy documented poorly differentiated adenocarcinoma. An abdominal ultrasound revealed a density in the right lobe of the liver; a needle biopsy confirmed carcinoma.

J. began CMF chemotherapy, but in November 1989, after completing three cycles, she refused further treatment. At that point there had been no improvement in her liver lesions. For several months she did nothing. She then learned of my work and, in April 1990, she began the program. After two years [sic] on her protocol, she felt so well that, without my knowledge, she discontinued the protocol. In July 1991 she suffered a gran mal seizure; a CAT scan revealed two brain lesions.

J. immediately resumed her full program, and showed rapid improvement in all symptoms. CAT scans of both the head and the abdomen on April 17, 1992, were completely normal and she remains well.

III. G. is a 55-year-old woman who noticed a right breast mass which her doctor diagnosed as mastitis in mid-1984. In August 1985 her right breast suddenly enlarged; a biopsy revealed poorly differentiated adenocarcinoma and inflammatory breast disease. In September 1985 G. began radiotherapy to the chest wall; in November 1985 she underwent a right modified mastectomy. The pathology report describes carcinoma in 17 of the 17 axillary nodes. After surgery G. began chemotherapy with CMF, which she continued for 2 years. However, in August 1987 a bone scan documented increased activity in the sternum, confirmed as metastases.

G. learned of my work and began her program in December 1987. Today, after six years, she follows her nutritional regimen and is in excellent health.

After my presentation, NCI suggested I carry out a closely monitored, 1-year pilot study of 10 patients with pancreatic cancer. We have an advisory panel of cancer researchers to monitor the project, which is fully funded under a private grant. We hope to see significant results within 18 months. AM

AM is the official bimonthly newsletter of the Office of Alternative Medicine (OAM), Office of the Director, National Institutes of Health, Bethesda, MD 20892-9904.

No permission is required to photocopy and disseminate AM among colleagues, students, and the public.

AM Volume 1, Number 6, July 1994

Published every other month by the Office of Alternative Medicine, NIH, Bethesda, MD

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