By Nicholas Gonzalez, M.D.
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
Scottish 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.
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.
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.
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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