The Gonzalez regimen was developed by Dr. Nicholas Gonzalez, who became interested in the use of pancreatic enzymes and dietary protocols as a possible treatment for cancer as a second-year medical student when he learned of a cancer treatment approach developed by a Texas dentist, William Donald Kelley, D.D.S. Dr. Kelley’s approach espoused, among other things, the use of pancreatic enzymes administered orally as anticancer agents. Reviewed in [2-5] The use of enzymes as a treatment for cancer was originally proposed nearly a century ago  and then resurfaced in the work of Dr. Max Gerson in the 1940s. The Gonzalez regimen was developed from these earlier theories and approaches.
A key concept underlying the original use of pancreatic enzymes for cancer treatment is the trophoblastic theory of cancer. When a human egg is fertilized by sperm, the early cell divisions produce a small ball of cells, which give rise to the blastocyst (preimplantation embryo). The blastocyst possesses a surrounding layer of cells known as the trophectoderm, which is made of individual cells called trophoblasts. Responsible for protecting the developing blastocyst and for mediating its attachment to the wall of the uterus, trophoblasts create the placenta. During the process of attaching the blastocyst to the uterine wall, trophoblasts express invasive qualities similar to those found in cancer cells. Trophoblasts, however, cease their invasive activity once the placenta is in place and functioning and then differentiate into other cell types.
When Scottish embryologist Dr. John Beard  first observed the invasive activity of trophoblasts in 1902, he speculated on the similarities between these cells and cancer cells. In addition, he observed that trophoblast invasiveness begins to decline at about the same time that the pancreas in the developing fetus begins to function. He also theorized that maternal pancreatic enzymes might play a role in containing trophoblastic invasiveness in the uterus. These considerations led to his proposal that cancer cells, like trophoblasts, arise from primordial germ cells. Dr. Beard also thought that some of these primordial cells—carrying latent capacities for invading tissues—could escape and spread throughout the body of the developing fetus. He thought it was possible that pancreatic enzymes modulated the degree of trophoblastic invasiveness in the uterus, he suggested that these same enzymes play a role in either limiting or eliminating cancerous cells elsewhere in the body. Reviewed in  Dr. Beard worked before the advent of molecular biology and human genetics. Although unable to experimentally establish that pancreatic enzymes had anticancer effects, he published papers and a book about his theory between 1902 and 1911. Other scientists of the time raised significant objections to the trophoblastic theory of cancer, and it was never broadly accepted. Reviewed in 
As Dr. Beard had before him, Dr. Kelley also asserted that trophoblasts and cancer cells have a common origin in primordial germ cells. Dr. Kelley maintained, furthermore, that cancer was initiated when primordial germ cells migrated to a point in the body already weakened by toxic exposure and nervous system imbalance. At these presumably compromised sites, the germ cells met no opposition from the immune system and initiated an aggressive invasion of normal tissue, creating malignancy. Dr. Kelley’s treatment approach was based on the belief that primordial germ cells are the single cause of all cancers, no matter where they occur, and that pancreatic enzymes are able to suppress or destroy cancers.[1,5]
Dr. Gonzalez incorporated many of Dr. Beard’s and Dr. Kelley’s key points into his own treatment regimen. In addition, the Gonzalez regimen includes the rigorous dietary protocols, nutritional supplements, and coffee enemas that can be found in the earlier work of Dr. Max Gerson. The Gonzalez regimen now includes use of pancreatic enzymes, along with nutritional supplements, coffee enemas, and prescriptive diets based on a theory of autonomic dominance.[2-4]
An example of the Gonzalez regimen for a patient with pancreatic adenocarcinoma would be the following:
- A diet that emphasizes fresh raw fruits, raw and lightly steamed vegetables, and freshly made vegetable juice daily. The diet protocol relies on plant-based sources such as cereals, nuts, and seeds and whole-grain products such as whole-grain bread and brown rice. The patient may eat one or two eggs daily, whole-milk yogurt daily, and fish two or three times a week, but no red meat or poultry.
- Nutritional supplements that include vitamins, minerals, and trace elements. Also prescribed are certain freeze-dried organ concentrates such as thymus and liver, derived from beef or lamb.
- Ingestion of 25 g to 40 g of porcine lyophilized pancreas product daily, in capsule form, taken away from meals and spread evenly throughout the day.
The total number of capsules taken per day by each cancer patient on the Gonzalez regimen typically ranges from 130 to 160, taken with and away from meals. In addition, the Gonzalez regimen uses coffee enemas on the premise that coffee absorbed through the intestinal wall will improve liver and gallbladder function and help increase the removal of toxic waste from tumor breakdown.[2,4] At this time there is no scientific evidence that coffee enemas have any specific effects on increased liver function, effects on tumor breakdown detoxification, or a role in the treatment of any cancer.
Doubts exist about the effectiveness of oral administration of pancreatic enzymes because pancreatic enzymes were not thought to be transported intact from the gut to the bloodstream. Evidence now suggests that intact digestive enzymes can be absorbed and resecreted by the pancreas, in a manner similar to the liver recycling of bile salts and hormones.[10-12]References
- Kelley WD: One Answer to Cancer. Mount Pearl, Canada: Cancer Coalition for Alternative Therapies, Inc. 1999. Also available online. Last accessed August 6, 2013.
- Gonzalez NJ, Isaacs LL: Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer 33 (2): 117-24, 1999. [PUBMED Abstract]
- Gonzalez N: Dr. Nicholas Gonzalez on nutritional cancer therapy: a Moneychanger interview. The Moneychanger July 1995. Also available online. Last accessed August 6, 2013.
- Gonzalez NJ: Pancreatic cancer, proteolytic enzyme therapy and detoxification [excerpts]. Clinical Pearls News November 1999. Also available online. Last accessed August 6, 2013.
- Kelley WD, Rohe F: Cancer: Curing the Incurable without Surgery, Chemotherapy, or Radiation. Bonita, Calif: New World Promotions, 2005.
- Beard J: The Enzyme Treatment of Cancer and its Scientific Basis. London: Chatto & Windus, 1911.
- Gerson M: The cure of advanced cancer by diet therapy: a summary of 30 years of clinical experimentation. Physiol Chem Phys 10 (5): 449-64, 1978. [PUBMED Abstract]
- Krebs ET Jr, Krebs ET Sr, Beard HH: The unitarian or trophoblastic thesis of cancer. Med Rec 163 (7): 149-74, 1950.
- Cohen LA, Aliaga C, Pittman B, et al.: Oral enzyme therapy and experimental rat mammary tumor metastasis. Life Sci 65 (24): 2603-14, 1999. [PUBMED Abstract]
- Leibow C, Rothman SS: Enteropancreatic circulation of digestive enzymes. Science 189 (4201): 472-4, 1975. [PUBMED Abstract]
- Rothman S, Liebow C, Isenman L: Conservation of digestive enzymes. Physiol Rev 82 (1): 1-18, 2002. [PUBMED Abstract]
- Isenman L, Liebow C, Rothman S: Transport of proteins across membranes--a paradigm in transition. Biochim Biophys Acta 1241 (3): 341-70, 1995. [PUBMED Abstract]