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Kirk Hamilton: What is your educational
background and current position?
Nicholas J. Gonzalez: I graduated from Brown University, Phi Beta
Kappa, Magna Cum Laude with a degree in English literature. I did
my premedical work as a postgraduate student at Columbia University,
and received my medical degree from Cornell University Medical College
in New York. I subsequently completed a year of internship in internal
medicine, and a fellowship in immunology.
KH: Where did you come up with the idea
at all to use pancreatic enzymes in cancer and what is the theoretic
mechanism?
NJG: I didn’t come up with the idea to use pancreatic enzymes to
treat cancer. The Scottish embryologist, John Beard, who worked
at the University of Edinburgh at the turn of the century, first
proposed in 1906 that pancreatic proteolytic enzymes, in addition
to their well-known digestive function, represent the body’s main
defense against cancer. He further proposed that pancreatic enzymes
would most likely be useful as a cancer treatment. During the first
two decades of this century, a number of physicians, both in Europe
and in the United States, used injectable pancreatic enzymes to
treat advanced human cancer, often times (depending on the quality
of the product) with great success. I have collected a number of
reports from that time in the major medical journals documenting
tumor regression and long-term survival in patients treated with
enzyme therapy. In my first article, I mentioned that in 1911, Dr.
Beard published a monograph entitled The
Enzyme Therapy of Cancer, which summarized his therapy and
the supporting evidence.
After Dr. Beard's death in 1923, the enzyme therapy was largely
forgotten. Periodically, alternative therapists have rediscovered
Dr. Beard's work, and used pancreatic proteolytic enzymes as a treatment
for cancer.
I began researching the use of oral pancreatic proteolytic enzyme
therapy as a treatment for cancer after completion of my second
year at Cornell University Medical College in 1981. My research
advisor at the time supported and directed my early work, and later
supported me during my formal immunology fellowship. In terms of
the theoretical foundation, the exact mechanism of action has never
been demonstrated. After Beard’s death, the enzyme therapy was largely
forgotten and certainly never generated any significant research
effort until recently with the funding of my work. There are several
studies from the 1960s showing, in an animal model, that orally
ingested pancreatic enzymes have an anti-cancer effect, and might
work through immune modulation, but these studies were preliminary
and were never followed-up. Dr. Beard believed enzymes had to be
injected to prevent destruction by hydrochloric acid in the stomach.
However, recent evidence demonstrates that orally ingested pancreatic
proteolytic enzymes are acid stable, pass intact into the small
intestine and are absorbed through the intestinal mucosa into the
blood stream as part of an enteropancreatic recycling process.
It is clear from our extensive clinical experience that pancreatic
proteolytic enzymes have a profound anti-neoplastic effect, but
we do not know how they work. We have not had the resources to support
basic science research, but with appropriate funding we do not believe
it would difficult to set up animal models to explore the molecular
action of the enzymes against cancer cells.
KH: Why did you choose a vegetable-based
diet, low in red meat and poultry, with a little fish and occasional
dairy products?
NJG: We divide patients into different metabolic categories, depending
on each patient’s particular genetic, biochemical and physiological
make-up. In this model, patients with solid epithelial tumors, such
as tumors of the lung, pancreas, colon, prostate, uterus, etc. do
best on a largely plant-based diet. Such patients have a metabolism
that functions most efficiently with a specific combination of nutrients
that are found in fruits, vegetables, nuts, whole grains and seeds,
and with minimal to no animal protein.
On the other hand, patients with the blood or immune based malignancies
such as leukemia, myeloma and lymphoma do best on a high-animal
protein, high-fat diet. Such patients do extremely well with a diet
based on animal products with minimal to moderate amounts of plant
based foods, the particular design of the diet again depending on
the individual patient’s metabolic make-up. We find patients with
pancreatic cancer always do best with a largely plant-based diet
that emphasizes fruits, vegetables and vegetable juice, nuts, seeds
and whole grains. Allowed protein includes fish one to two times
a week, one to two eggs daily and yogurt daily, but no other animal
protein. In our therapy, we use diets specifically because of the
effect of food on the autonomic nervous system. This system consists
of the sympathetic and parasympathetic branches and ultimately controls
all aspects of our physiology, including immune function, cardiovascular
activity, endocrine function and the entire action of our digestive
system. The sympathetic and parasympathetic systems have opposing
actions on the target organs and so can adjust our physiology depending
on needs and demands, enabling our bodies to react to any situation,
condition or stress. We believe disease, whatever the form, occurs
because there is an imbalance in autonomic function. For example,
we find solid tumors, such as tumors of the breast, lung, pancreas,
colon, uterus, ovaries, liver, etc occur only in patients who have
an overly strong sympathetic nervous system and a correspondingly
weak, ineffective parasympathetic nervous system. We believe that
blood-based cancers, such as leukemia, lymphoma and multiple myeloma,
only occur in patients that have an overly developed parasympathetic
nervous system, and a correspondingly weak sympathetic nervous system.
Previous research, such as Dr. Francis Pottenger’s research during
the 1920s and 1930s proposed that much if not all disease has autonomic
imbalance as at least one of the major causes.
We have found that specific nutrients and foods have specific,
precise and predictable effects on the autonomic nervous system.
For example, a vegetarian diet emphasizes fresh fruits and vegetables,
particularly leafy greens, and contains large doses of minerals
such as magnesium and potassium. It has been shown in many studies
that magnesium suppresses sympathetic function, while potassium
stimulates parasympathetic activity. Furthermore, a largely vegetarian
diet tends to be very alkalinizing, and the neurophysiologic research
documents that in an alkalinizing environment, sympathetic activity
is reduced and parasympathetic activity increased. So, whatever
other effect a vegetarian diet has, in terms of autonomic nervous
system function, such a diet will reduce sympathetic activity and
stimulate the parasympathetic system.
A meat diet is loaded with minerals such as phosphorous and zinc,
which tend to have the opposite effect. A high-meat diet stimulates
the sympathetic system and tones down parasympathetic activity.
Furthermore, such a diet is loaded with sulfates and phosphates
that in the body are quickly converted into free acid, that in turn
stimulates the sympathetic nervous system while suppressing parasympathetic
activity.
So, by the careful use of diet, we are able to effect major changes
in autonomic function, and bring about balance in a dysfunctional
nervous system. We find, further, as the autonomic system comes
into greater harmony and balance, when the autonomic branches are
equally strong, all systems – from the immune system to the cardiovascular
system – work better regardless of the underlying problem. In essence,
we are using diet to bring about greater physiological efficiency.
For cancer patients, long experience has taught us that it is not
enough to load patients with enzymes; the question of autonomic
imbalance must also be addressed. In terms of pancreatic patients
specifically, a plant-based diet provides all the nutrients to correct
autonomic dysfunction.
KH: Can you describe the vitamin and
mineral supplement regimen you used? Was it megadoses or a basic
nutritional support?
NJG: All of our patients, whether they have cancer or some other
problem, consume specific combinations of vitamins, minerals, trace
elements, amino and fatty acids, and animal-derived glandular and
organ concentrates. We use such supplements very specifically, in
very precise doses and combinations as we use diet, to manipulate
autonomic function and to bring about balance to an imbalanced system.
Certain vitamins, minerals and trace elements, such as many of the
B vitamins and, as mentioned above, magnesium and potassium, tone
down the sympathetic nervous system and stimulate the parasympathetic
nerves. Other nutrients, particularly calcium, phosphorous and zinc,
stimulate the sympathetic system but weaken the parasympathetic
system. By the use of precise combinations of vitamins, minerals
and trace elements, along with diet, we are able to bring about
balance to the autonomic system. And, again, when the autonomic
branches come into balance, the patients, whatever the underlying
disease, do better.
KH: What is the role of coffee enemas
in this particular treatment and what is the history of coffee enemas
in traditional medicine?
NJG: When I first began my research efforts, I was very surprised
to find that the coffee enemas, often portrayed as one of the most
bizarre aspects of alternative medicine, came right out of the Merck
Manual, a revered compendium of orthodox treatments. When
I was completing my immunology fellowship, I had an interesting
correspondence with the then editor of the Merck
Manual, who confirmed that the coffee enemas had been advocated
in the Merck Manual from about
1890 right up until 1977, when they were removed more for space
considerations than anything else. Most nursing texts for the better
part of the century recommend coffee enemas. Particularly during
the 1920s and 1930s coffee enemas were used in the US and abroad
to treat a variety of conditions, and I have put together a library
of articles from that time discussing the wide ranging effects on
patients. Coffee enemas were frequently recommended because patients,
whatever their underlying problem, tended to feel better after a
coffee enema. I have followed thousands of patients over the years
who have done coffee enemas in some cases for decades: virtually
all patients report an increase sense of well being. I have done
them myself daily since first learning about them in 1981.
There is research going back to the earlier part of the century
that indicated that coffee enemas stimulate more efficient liver
function and gallbladder emptying, and we believe that is the primary
therapeutic benefit. Particularly with cancer patients, who often
have a very large tumor burden, as the body repairs and rebuilds
and as tumors break down, enormous amounts of toxic debris can be
produced, much of which must be processed in the liver. The coffee
enemas seem to enhance this processing of toxic metabolic waste.
Interestingly enough, in Hospital Practice (August 15, 1999 page
128), a very orthodox journal of internal medicine, I read a summary
of an article showing coffee seems to enhance gallbladder and liver
function.
KH: Is it possible that the positive
effects from the coffee enemas are a result of a "caffeine
high" versus a metabolic benefit?
NJG: The issue of a caffeine high is often raised. I don’t believe
this is the case at all. First, patients almost universally report
a relaxing effect, not the stimulation you find with coffee taken
orally. Many patients, in fact, fall asleep while doing the enemas.
I, myself, have never been able to tolerate drinking coffee because
coffee, when drunk, causes in me an amphetamine like response. However,
I always feel relaxed when I do a coffee enema and often fall asleep.
Something completely different is going on with the enemas.
KH: Can you describe your study and the
basic results?
NJG: In July 1993, the then Associate Director for the Cancer Therapy
Evaluation Program at the National Cancer Institute, Dr. Michael
Friedman, invited me to present selected cases from my own practice
as part of an NCI effort to evaluate non-traditional cancer therapies.
I prepared for presentation 25 cases with poor prognosis or terminal
illness who had either enjoyed long-term survival or tumor regression
while following my program. After the session, Dr. Friedman suggested
we pursue a pilot study of our methods in 10 patients suffering
inoperable adenocarcinoma of the pancreas, with survival as the
endpoint. Because the standard survival for the disease is so poor,
an effect could be seen in a small number of patients in a short
period of time.
Nestec (the Nestle Corporation) agreed to fund the trial, which
began in January 1994. The study has been completed and was published
in Nutrition and Cancer, June, 1999;33(2). Of 11 patients
followed in the trial, eight of 11 suffered stage four disease.
Nine of 11 (81%) lived one year, five of 11 lived two years (45%),
and four of 11 lived three years (36%). Two are alive and well with
no signs of disease, one at 3.5 years and one at 4.5 years. In comparison,
in a recent trial of the newly-approved drug gemcitabine, of 126
patients with pancreatic cancer not a single patient lived longer
than 19 months.
As a result of the pilot study, the National Cancer Institute approved
$1.4 million over five years for a large scale, randomized clinical
trial comparing my nutritional therapy against gemcitabine in the
treatment of inoperable pancreatic cancer. This study has full FDA
approval and is being conducted under the Department of Oncology
and the Department of Surgical Oncology at Columbia Presbyterian
Medical Center in New York. The trial is the outgrowth of a Congressional
hearing last summer encouraging intensive government evaluation
of promising alternative cancer treatments, and is currently up
and running. We are accruing patients right now for the study, and
interested patients can learn more about this study and its objectives
from Michelle Gabay, in the office of Dr. John Chabot, M.D., Chief
of Surgical Oncology at Columbia, phone (212) 305-9468.
KH: Were there any side effects to this
high dose (130 and 160 capsules per day) of pancreatic enzymes?
It seems like that would cause some significant gastrointestinal
irritation.
NJG: The only side effects I have noticed in 12 years of treating
cancer patients with high dose porcine-based pancreatic enzyme therapy
are intestinal gas, occasional bloating, and occasional indigestion.
Frankly, the side effects tend to be very minimal. The enzymes we
use are made specially for my patients in New Zealand. I believe
most pancreatic enzymes available either as a prescription or over
the counter in health food stores are not effective against cancer.
We actually had to develop a manufacturing process to produce what
I think are the appropriate enzymes, and they are not available
except to my patients. Until we prove the benefit of my work, I
don’t think it is appropriate to mass market the enzymes. I also
don’t think it appropriate for cancer patients to try and treat
themselves.
KH: How compliant were your patients
to this regimen?
NJG: Pancreatic cancer patients are notoriously medically unstable,
and some patients in the study were so weak they had difficulty
complying fully at times, although many of the patients did comply
well. Generally, we find that the better the compliance, the better
the effect of the treatment. Patients in the trial came from all
over the country, and because our approach is still alternative,
patients were not allowed to continue the treatment when hospitalized.
In the Columbia study, all patients are going to be treated aggressively
for underlying medical problems and will be encouraged to continue
their therapy at all times.
KH: What would you like to see in the
future with regard to evaluating this protocol as far as studies
go?
NJG: As above, we are involved in a large scale, NCI-funded, FDA-approved
randomized clinical trial at Columbia University.
KH: What feedback have you gotten from
the traditional oncology community with regard to your work?
NJG: The attitude is changing; for example, I have sent you a very
supportive article about my work that appeared in the magazine InTouch,
a news style magazine that is sent to more than 90,000 orthodox
physicians, including all oncologists in this country. The oncology
newspaper Oncology News International
had a very nice piece about my research efforts, and I have sent
you a copy of that story. I have also sent a copy of a press release
in support of our work sent out from Congressman Dan Burton, Chairman
of the Committee on Government Reform.
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