The Gonzalez Therapy : A Look Back, And an Update

By Nicholas Gonzalez, M.D.

With permission from totalhealth Magazine, Volume 26, No. 3. For subscription information, call 1-888-316-6051.

I've learned over the years, as Dr. Linda Isaacs and I continue the battle to have our work appropriately studied, tested, and one day, hopefully, accepted into the canon of orthodox medicine, nothing is more frightening than a new idea - except, perhaps, a disturbing old truth that simply won't behave and go away.

As many readers of totalhealth know from prior articles about our work, in our practice we offer an aggressive nutritional program for treatment of advanced cancer and a variety of other serious illnesses ranging from chronic fatigue to multiple sclerosis. Whatever the underlying problem, our therapy involves three basic components: individualized diets, individualized supplement protocols and intensive detoxification.

The diets we prescribe range from vegetarian raw foods to an Atkins' type red meat extravaganza. The supplement programs are equally as varied, involving vitamins, minerals and trace elements in various forms and various doses, as well as glandular and enzyme products, chosen to meet a particular need in each individual patient. The detoxification routines, often the most misunderstood component of our therapy, consist of coffee enemas and a variety of other procedures which help the body neutralize and excrete the multitude of toxic waste products we produce ourselves every second during our routine metabolism as well as what we take in from our increasingly poisoned environment.

Though we treat many diseases, we are perhaps best known for our work with advanced cancer. For patients suffering malignancy, we rely on large doses, spread through the day, of orally ingested pancreatic enzymes derived from a pig source. While the diets, the vitamins, minerals and trace elements help a damaged body repair and rebuild from the ravages of any physiological assault, in our therapy it is the pancreatic enzymes that we believe specifically target and attack cancer cells. The pancreatic enzymes are the true essence of our cancer protocols.

I wish I could claim that I was the first human to have believed that humble pancreatic enzymes, particularly the proteolytic enzymes, have an anticancer effect and represent the body's main defense against cancer. I wish I had realized that these commonly available, not genetically engineered, non-test tube created proteins might be a wonderful way to deal with this most insidious disease. I say this not out of any need for glory or ego gratification, since my foray into enzyme therapy has led to all manner of personal attack and long periods of professional isolation. So it certainly isn't the glory; I wish that I were the first because then I wouldn't feel so glum, when I realize the research community at large missed an incredible opportunity a 100 years ago, one that might have led to a true understanding of cancer, its control, perhaps even its defeat. Perhaps, had scientists behaved differently, much human suffering caused by this disease might have been averted.

As I discussed previously in totalhealth, it was the eminent scientist Dr. John Beard, professor at the renowned University of Edinburgh, who in an article in Lancet in 1902 first proposed that the pancreatic proteolytic, protein digesting enzyme trypsin might represent a powerful anticancer tool. One which would potentially offer the solution to this frightening illness. Beard did not pull this idea out of the air; rather it was the careful culmination of 20 years of meticulous laboratory investigation that began with his own studies in, of all things, the development of the fish embryo.

Beard was not a physician, nor in his early career, even vaguely interested in medical research, let alone cancer; he was an embryologist and quite happy as an embryologist, devoted to unraveling the details of fetal growth and development in all manner of species, from shark to man.

After I first presented Dr. Beard to totalhealth readers some years ago, I embarked upon an intensive study of Beard's work beginning at his beginning, with his Ph.D. thesis presented to the faculty of science at the University of Freiburg, where he did much of his graduate work. I was able to find a copy from a second hand bookseller recommended by my friend, the noted scholar and writer Dr. Ralph Moss, who happened to have a full collection of Beard's somewhat esoteric early writings. His Ph.D work, for example, dealt with the development of the nervous system of an obscure fish. As his career evolved he focused his attention on the nervous system of the mammalian embryo, as it grew and matured. Many of his pioneering findings from this period in his life have proven correct and are standard fare in the embryology texts of our day.

It was his fascination with nerves, how they form and grow in the embryo, that through a most convoluted route led him to consider the development of the placenta, the tissue that anchors the mammalian fetus to the uterus and serves as the point of connection between the blood supply of the fetus and the blood vessels of the mother. Beard was the first to report that in many respects the placenta in its early stages behaves much like a tumor. It begins growing as a very undifferentiated offshoot from the earliest stage of the embryo. Very quickly, as Beard observed, the early placental cells invade the mother's uterus, much as a tumor infiltrates host tissue in any organ, the placenta grows initially almost without control, as tumors were known to do even in Beard's day, and it quite efficiently produced a dense blood supply - a requirement for any rapidly growing tumor, as angiogenesis research today has made very clear indeed.

But then of course, as normal development proceeds, there is a not very subtle change in direction, from a highly invasive, rapidly growing, blood vessel producing tumor-like tissue, to the mature noninvasive, nonproliferating life-sustaining placenta. The only difference between the placenta and a malignant tumor, thought Beard, was that the placenta knew just when to stop growing and tumors don't.

Beard learned through years of late night hours in his laboratory that the key to the change lay in the embryonic pancreas. As witnessed in every species he studied, the moment the placenta stopped its relentless, cancer-like invasion of the mother, was the very day the embryonic pancreas became active and began pouring out enzymes.

Even in Beard's day, more than 100 years ago, the main categories of pancreatic enzymes had already been identified; the proteolytic, or protein digesting component, the lipases that digest fat, and the amylases, responsible for cleaving complex carbohydrates into simple, easily usable sugars. The activity of all three groups was thought by physiologists of the time to be limited to the duodenum, the first part of the small intestine, where the enzymes continued the breakdown of food arriving from the stomach, where digestion begins. The enzymes were known to be important, in their way, necessary for digestion of course, but quite dull, with no other significant presumed purpose.

But Beard effectively provided data which supported his contention that above and beyond this function trypsin, the main proteolytic enzyme, served to control placental growth and prevent the tissue from invading beyond the uterus, as a true cancer might, destroying everything in its path.

Beard then made a leap of faith which might have changed the course of cancer medicine had he been taken more seriously. Logically, he assumed that since the early placenta behaves much as a tumor does, since under the microscope its cells even look like undifferentiated, primitive neoplastic cells, and since pancreatic enzymes forcefully regulate its growth and development, these very same enzymes could be, in fact must be, the body's main defense against cancer, and would be useful as a cancer treatment.

Beard, careful scientist that he was, first tested his thesis in the one animal tumor model available at the time, the Jensen's mouse sarcoma. He injected an extract of trypsin into mice growing such cancers and the tumors regressed - an extraordinary achievement. Subsequently, during the first decade of the twentieth century, a number of physicians interested in Beard's hypothesis began, under his direction, to use injectable pancreatic enzymes to treat their human cancer patients. The successes were published in the major medical journals of the day, including Lancet and The British Medical Journal. I have read as many of these documents as I have been able to track down, and they remain to me extraordinary reports of patients surviving advanced cancer - such as one with a fungating laryngeal cancer, well beyond any chance of surgical cure, whose tumor under enzyme therapy regressed, then fell off. The patient thereafter lived a normal, cancer-free life. Other articles described patients with metastatic colorectal and breast cancer, as deadly today as in Beard's time, evidently disease free after the enzyme treatment - all carefully documented and appropriately presented in the scientific literature. One would think that such reports would have quickly mobilized the power of the medical research community behind Beard, to help him advance his promising theory. Instead, the enzyme thesis and the supporting animal and laboratory data, provoked an enormous and angry backlash against Beard and his few loyal followers. The Scotsman was vilified in editorials in medical journals, mocked in the newspapers, belittled at scientific conventions. But Beard stuck to his course, fought back in articles and letters to the editor, and never once wavered. In 1911 he published The Enzyme Treatment of Cancer, a monograph which outlined his decades of research, his impeccably thought out hypothesis, his promising and compelling results. However, despite such valiant efforts, interest in Beard's thesis gradually petered out and when he died in 1924, he died frustrated, angry and ignored, his therapy already considered no more than an historical oddity.

I have often pondered the vitriolic - and irrational - response of so many eminent researchers and scientists to Beard's well-documented approach, reactions that nearly buried the treatment for good. He was trained impeccably as a scientist and behaved throughout his professional life as a true researcher, carefully documenting his laboratory and clinical results in the mainstream medical literature. But it made no difference, at all.

The rejection of enzyme therapy 100 years ago had really nothing to do with science but everything to do with politics, psychology, and popularity. Beard was a very nerdy ivory tower scientist, who had little patience for his critics whom he saw as unacceptably ignorant. He didn't court the press, didn't care about fame, didn't seem at all interested in international acclaim. His refusal to play the political game properly, his refusal to court his colleagues and the media of the day I believe worked against him. I also think that his approach was just too simple, perhaps not mysterious enough to enchant his fellow researchers.

At the same time Beard intently pursued his own determined course, other scientists such as Madame Curie, more lauded, more media friendly, more adored, extolled the benefits of the newly discovered x-ray as a perfectly safe, effective, non-toxic treatment for all cancer. The press of the time, the scientific and medical community at large latched onto radiation as the final solution to this frightening and deadly plague. Of course, the enthusiasm for the mysterious invisible emanation was misplaced, but it wasn't until Beard was long gone that the medical community realized that few cancers responded to radiation, that it wasn't perfectly safe as originally thought but instead terribly toxic, in fact carcinogenic in and of itself. Madame Curie herself would die from cancer brought on by her exposure to radiation, as would many other x-ray enthusiasts.

After Beard's death, periodically other physicians and scientists rediscovered his work and kept the idea alive. During the 1920s and 1930s, a St. Louis physician, Dr. F.L. Morse, reported that he had successfully treated a number of advanced cancer patients with pancreatic enzymes. When he presented his well-documented findings to the St. Louis Medical Society in 1934 - a proceeding published in the Weekly Bulletin of the St. Louis Medical Society (Vol. 58: 1934) - his colleagues attacked him viciously and relentlessly. One physician at the session, a Dr. M.G. Seelig, remarked: "While I heartily agree with Dr. Allen when he strikes the note of encouragement, I recoil at the idea of witlessly spreading the hope of a cancer cure which is implicit in the remarks of Dr. Morse this evening�"

During the 1960's, the eccentric dentist, Dr. William Kelley, again rediscovered Beard's forgotten work and developed his own variation of enzyme treatment. In addition to large doses of orally ingested pancreatic enzymes, Kelley's program included individualized diets and supplement protocols and detoxification routines. Dr. Kelley came to fame at a time of great repression organized against alternative medicine in general, and particularly against anyone foolish enough to suggest a nutritional treatment might have benefit against deadly cancer. Kelley was at particular risk because as a dentist he was not legally entitled to treat cancer in the first place. He was repeatedly attacked in the press, vilified as a "quack," investigated by numerous government agencies. He was thrown in jail as a public menace, had his dental license revoked for five years for practicing medicine, spent his earnings defending himself against government assaults and saw his family life fall apart. But he, like Beard, never relented and continued seeing patients. He survived because his successes created an extraordinary word of mouth network, that brought an endless stream of patients to his Grapevine, Texas - and later his Winthrop, Washington offices.

I met Dr. Kelley by chance during the summer following my second year of medical school. At that time he seemed completely modest and unassuming, seeking only to have his work properly evaluated so that if the approach had merit, it might become more widely accessible to patients in need. I was fortunate to have as a mentor at Cornell Medical College the late Robert A Good, M.D., Ph.D., who encouraged a review of Kelley's cases. Dr. Good, then President of the Sloan-Kettering Research Institute, was the most published author in the history of the biomedical scientists, the "Father of Immunology," as the New York Times described him, the man who performed the first bone marrow transplant in history.

Under Dr. Good's direction, I began a student project evaluating Dr. Kelley's patients, his methods, his successes and failures. Dr. Good, wise teacher that he always was, told me that even if Kelley proved to be a fraud, I would learn much medicine from a project of my own choosing, developed out of my own enthusiasm.

Despite what was said then and is said today, despite the eccentricities in his behavior then and now, I quickly realized Kelley was not a fraud. During a rather extraordinary summer spent reading through Kelley's records in his main Dallas office, I quickly found evidence of what appeared to be patient after patient with appropriately diagnosed, biopsy proven advanced and even terminal cancer, who were alive five, even 10 years since first beginning the enzyme therapy. What began as a mere student investigation evolved into a full-fledged research project, completed while I was a fellow in Dr. Good's group which, after he was pushed out of Sloan, ended up in Florida.

I eventually interviewed and evaluated over 1000 of Kelley's patients and concentrated on a group of some 455. From this population I wrote up in detail 50 cases, representing 26 different types of cancer. Even today, 20 years later, when I review my earnest efforts, I am still impressed by Kelley's achievement.

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For example, one of these patients, a woman who ran a gas station with her husband in Wisconsin, was diagnosed with metastatic adenocarcinoma of the pancreas, the worst form, with metastases into the liver. The Mayo clinic confirmed the pathology, offered no treatment and told her she might live two months. When last heard from in the mid-1990s, when she referred a patient to my office, she was still alive and well, more than 15 years from diagnosis. Another patient, with metastatic uterine cancer that had recurred and metastasized within the pelvis and to the lungs in 1975, enjoyed a documented reversal of all her tumors under Dr. Kelley's care. When last heard from in the early 1990's, nearly 20 years after her cancer explosion, she was in her mid-eighties and perfectly well.

By 1986, I had put the results of my five-year investigation into monograph form and was excited by the prospect of publishing such unusual case reports and presenting the documentation for this nutritional, non-toxic treatment. To my disappointment and surprise, despite my careful labors and serious intent, I could not get the book published, either in its entirely as a monograph or as a summary journal article. The responses from editors ran the gamut from disbelief and accusations of fraud, to fear that the book would generate so much controversy that publishing careers might be ruined. No editor, even those who accepted the data as real, had the courage to take on the project.

This disappointment, our inability to get the study published, had a very damaging effect on Dr. Kelley. It appeared to him once again that all doors had closed, that his work would never be accepted for what he believed it was, a promising answer to a deadly disease. In 1986, he closed down his office and eventually disappeared from sight. I have not spoken with him since 1987. Determined to keep the enzyme therapy alive, I left Dr. Good's group when I finished my fellowship and returned to New York in 1987. I then began seeing patients myself, always with the hope of obtaining proper research support from the academic world. [The monograph on Dr. Kelley was published in 2010 by New Spring Press; it is also available on Amazon]

In retrospect, 17 years later, I am somewhat amazed at how determined I was, and how sure that if I just kept trying, I would be able to win the battle, get the research support needed, prove the benefit of the treatment. I made serious professional choices. After coming back to New York, I was offered a position at Sloan-Kettering by one of my former professors who had remained in contact with me and who seemed to think I had some promise as an academic scientist. But he wanted me to pursue more acceptable, more mainstream research projects and give up such flagrantly controversial work. I was touched by his interest and concern but turned down the offer; I simply could not walk away from the enzyme work. I just couldn't.

The work was initially very difficult since the patients who came to us invariably had advanced disease. But with my colleague, Dr. Linda Isaacs, we began having successes. There were victories that kept us going, patients who seemed to beat their cancer, many of whom are alive today. One of the first patients who consulted me after I opened up my practice back in December of 1987, had been diagnosed with metastatic inflammatory breast cancer with multiple metastases to bone, that had developed while she was receiving aggressive chemotherapy. She is alive now more than 16 years since her original diagnosis and the most recent scans show total absence of her previous extensive disease.

Then there is my patient Mort, with metastatic adenocarcinoma of the pancreas diagnosed in September of 1991 with multiple lesions in the liver, evidence of cancer in the adrenals, bone and lung, who now is alive more than 12 years with no sign of disease. He is 82 years old, and doing well except that his wife complains he is absent-minded.

In July of 1993, the National Cancer Institute invited me to present case reports from our practice, detailing patients with appropriately diagnosed poor prognosis cancer who had enjoyed tumor regression or unusual survival while following my therapy. Dr. Isaacs and I put together 25 cases for the session, including the breast cancer patient and Mort, described above. The session, attended by a large group of NCI scientists, lasted three hours and afterwards I was asked to pursue as a next step a pilot study evaluating my approach with 10 patients diagnosed with advanced adenocarcinoma of the pancreas. In such phase II studies, as they are technically called, a promising new therapy is administered to patients with an aggressive cancer for which there is no effective standard treatment. A pilot study involves no control group, but can still give important information about a treatment. Since inoperable pancreatic cancer has such a grim prognosis, with an average survival in the range of five months, the associate director who chaired the meeting suggested that if I could get three patients to live a year, that would be a significant success. From my experience with enzymes, I expected to do better.

We were fortunate to get funding for the study from Nestle, the giant international food conglomerate. The then vice president of the company in charge of research, Dr. Pierre Guesry, who had formerly been medical director of the Pasteur Institute in Paris, had learned of our work and become a supporter.

We finished the study and published the results in June 1999, in the peer reviewed research journal Nutrition and Cancer. We had eventually included 11 subjects, adding a patient when one dropped out. Of the 11, all had biopsy proven, inoperable disease, eight of the 11 had stage IV, most had been very sick prior to consulting with us. All the patients were approved by a consulting oncologist and a cancer epidemiologist. Of the 11, nine lived more than one year, five lived more than two years, four lived more than three years, and two made it beyond four years. As a point of reference, in the clinical trial of Gemzar, the latest drug approved for the disease, of 126 patients treated with chemotherapy, not one lived longer than 19 months. Ours were results that had not previously been reported for the disease.

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As many of you know, that study would again generate considerable controversy. Scientists who had never spoken to me once about the project, who knew nothing of its origins, questioned the methodology, though it had been developed in consultation with the NCI and eminent researchers from other institutions. The results were questioned, one scientist from Harvard claiming - though again he had never once spoken to me - that the patients didn't have pancreatic cancer, even though they had all been extensively worked up before seeing us and approved for entry into the trial by consulting specialists.

But at least some seemed to take the results seriously and shortly after publication of the article, the NCI approved funding for a large scale, phase III clinical trial, again testing our enzyme approach in patients with advanced pancreatic cancer, but this time against a control group that would receive the best available chemotherapy. Eventually, the protocol was approved by the FDA, and the National Center for Complementary and Alternative Medicine offered to put up the required funding, initially in the range of $1.4 million. Columbia University, under the chief of oncology at the time, and the chief of surgical oncology, became the supervising institution in New York, where the study would be run.

As this project has moved along, Dr. Guesry at Nestle, provided funding for studies to test the enzyme treatment in animal models, to provide supportive data as the human trials continue. He interested a group at the Eppley Cancer Institute of the University of Nebraska, known for their investigations into the molecular biology of pancreatic cancer, to take on the challenge. Dr. Parviz Pour, the supervisor of the animal work at Nebraska, has himself developed mouse models of pancreatic cancer that are used to test promising new treatments against the disease.

Just this May, 2004, the results of the experiments were published in the peer reviewed journal Pancreas. I am listed as a co-author. In these studies, the researchers evaluated the effect of our enzymes in nude mice injected with human pancreatic cancer cells of a particularly virulent strain. These mice lack a functional immune system, so normally the tumors grow very rapidly and kill quickly. In the first study, which measured survival, the mice were divided into two groups, one receiving our enzymes, the other given no therapy. The animals treated with our enzymes survived significantly longer than the untreated control group, and additionally, the enzyme mice appeared to be healthy, happy mice, even well into the study, in sharp contrast to the controls, who were listless, inactive, bloated and obviously quite ill. In fact, two of the mice in the treated group were doing so well they had to be sacrificed so the study could be brought to conclusion. I wonder how long they would have kept going.

In a second experiment, again the mice were divided into two groups, one administered our enzymes, the other an untreated control. This time, animals were periodically sacrificed and evaluated for tumor growth. The enzymes clearly reduced the proliferation of the tumors, which in the treated mice remained small and very localized. In the controls, tumors were considerably larger, more invasive. Though in this study, the rate of tumor growth was the primary endpoint, the treated animals again lived considerably longer.

I want to emphasize that to me, the results are particularly significant because we have never used the enzymes to treat animals before and decided to start at the dose per kilogram that we would normally use in humans. Inbred laboratory mice, however, metabolize most drugs far differently than we humans and normally doses much higher than what would be given humans must be administered to get an effect. And the experiments only evaluated the enzyme component of the treatment, not the additional vitamins, minerals, trace elements and nutritious food we prescribe for our human patients. The animal chow also contained a fair amount of soy, and soy isoflavones, however aggressively they may be pushed as health nutrients, are among the most potent natural trypsin inhibitors known.

So we believe the results are important. As the authors wrote in the "Discussion" section, "In summary, PPE (Porcine Pancreatic Extracts) is the first experimentally and clinically proven agent for the effective treatment of PC (Pancreatic Cancer). The significant advantages of PPE over any other currently available therapeutic modalities include its effects of physical condition, nutrition and lack of toxicity." Note that these results validate only the specific enzymes we use in our therapy and no other commercially available formulation.

I am starting to believe that finally, after 100 years, Dr. Beard and his enzyme treatment will get some well deserved recognition and finally, cancer research might at least to some extent be channeled toward a more hopeful, less toxic, more successful direction.

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Copyright © Nicholas J. Gonzalez, M.D.
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