By Nicholas Gonzalez, M.D.
The embryologist Dr. John Beard proposed in 1906 that pancreatic
proteolytic digestive enzymes represent the body's main defense
against cancer, and that enzyme therapy would be useful as a treatment
for all types of cancer. (1) Particularly during the first two decades
of the twentieth century, Dr. Beard's thesis attracted some attention
in academic circles, and several case reports in the medical literature
documented tumor regression and even remission in terminal cancer
patients treated with proteolytic enzymes. (2-6) In 1911, Dr. Beard
published a monograph entitled The Enzyme Therapy of Cancer,
which summarized his therapy and the supporting evidence. (7)
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. (8)
Dr. Beard believed the 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
(9), pass intact into the small intestine, and are absorbed through
the intestinal mucosa into the blood stream as part of an enteropancreatic
recycling process. (10,11)
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. At that time,
I had the opportunity to meet Dr. William Donald Kelley, the Texas
dentist who for twenty years had been treating cancer patients with
a complicated nutritional therapy based on Beard’s enzyme treatment.
Although Kelley had been attacked in the press because of the unorthodox
nature of his work, the Dr. Kelley I met was an unassuming man whose
primary wish was to have his controversial work fairly evaluated
by the academic medical world. I thought his request reasonable.
My research advisor at Cornell, Dr. Robert A. Good, at the time
President of Sloan-Kettering, agreed to support a case review of
Kelley's patients, which I continued despite the rigors of third
year medical school. During my fourth year at Cornell, I was given
a considerable block of time under Dr. Good's direction to investigate
Kelley's work and results in a more structured manner. Eventually,
what began as a student project developed into a two-year formal
research effort which I pursued during my formal immunology training.
During my study, I reviewed nearly 10,000 of Dr. Kelley's patient
records. I interviewed and evaluated intensively over 500 patients
with appropriately diagnosed advanced cancer, and summarized my
findings in an extended monograph completed in 1986 as partial fulfillment
for my fellowship training.
The written report consisted of several sections. In addition to
outlining Kelley's theoretical approach, I discussed at length 50
of his patients initially diagnosed with 26 different types of poor
prognosis cancer, all of whom had enjoyed long-term survival and/or
apparent regression of disease while following their nutritional
regimen. As a separate chapter, I also evaluated all cases of unresectable
pancreatic cancer, both compliant and non-compliant, who had come
to see Kelley between 1974 and 1982. I eventually identified 22
patients in this group. For all of these patients, I obtained complete
medical records, including death certificates for those who were
deceased. I interviewed all surviving patients repeatedly and at
length, and in the case of those who had died, I interviewed family
members as well as the original attending physicians.
Ten of these patients had visited Kelley only once and had never
followed the protocol: these individuals had been discouraged from
proceeding largely because of the negative influence of family and
physicians who thought Kelley to be an outright fraud. This population,
with a median survival of only 60 days, served as a convenient control.
Among the remaining 12 patients, I found a number who had survived
far beyond what would be expected for the disease, including one
patient with pancreatic cancer to the liver who had, when last contacted,
been alive over twenty years from her original diagnosis. (Discoveries
in Medicine review)
Despite the careful documentation and the five-year investment
of time, no one in academic medicine could, at the time, accept
that a nutritional therapy might produce positive results with advanced
cancer patients.
In 1986, probably as a result of endless pressures, Dr. Kelley
gave up research and patient care, and I myself have not spoken
to him or any of his associates since 1987. He passed away in January
2005. (Obituary
of Dr. Kelley) In 1987, I decided to move to New York to try
and salvage the enzyme approach, and observe for myself the results
with poor prognosis cancer patients. My goal throughout has been
to generate research support, so that this method, if it indeed
proved to have value, could be integrated into general medical treatment.
In July of 1993, the then Associate Director for the Cancer Therapy
Evaluation Program at the National Cancer Institute invited me to
present selected cases from my own practice as part of an NCI effort
to evaluate non-traditional cancer therapies. Dr. Isaacs and I prepared
for presentation 25 cases representing a variety of poor prognosis
or terminal malignancies who had either enjoyed long term survival
or tumor regression while following my program. (NIH
newsletter description) Included in my presentation were patients
diagnosed with advanced breast, lung, prostate and other cancers.
Most of these patients are still alive, now more than ten years
since that presentation.
After the session, the Associate Director suggested we pursue
a pilot study of our methods in ten patients suffering inoperable
adenocarcinoma of the pancreas, with survival as the endpoint. He
suggested pancreatic cancer because the standard survival for the
disease is so poor, and an effect could be seen in a small number
of patients in a short period of time. In fact, I was told
that if three of ten patients lived a year, that would be considered
a positive result. Nestec (the Nestle Corporation) agreed to fund
the trial, which began in January 1994. The study has been completed
and was published in the June 1999 issue (Volume 33, Number 2) of
Nutrition and Cancer. Of 11 patients followed in the
trial, 8 of 11 suffered stage IV disease. Nine of 11 (81%) lived
one year, 5 of 11 lived two years (45%), 4 of 11 lived three years
(36%) and two lived longer than four years. In comparison, in a
trial of the drug gemcitabine, of 126 patients with pancreatic cancer
not a single patient lived longer than 19 months. (12) (Abstract
of Nutrition and Cancer article) Subsequently, the National
Cancer Institute, in conjunction with the National Center for Complementary
and Alternative Medicine, approved funding for a large-scale controlled
trial evaluating our approach against chemotherapy, again in patients
diagnosed with pancreatic cancer. Unfortunately, despite our initial
enthusiasm for the project, ultimately it was ineptly managed by
the academicians involved. The supervisory personnel at Columbia
admitted multiple patients into the nutritional arm of the study
whom we believed failed to meet the very specific entry requirements,
and who for the most part were far too sick to comply with our treatment.
Our multiple complaints were largely ignored. Finally, at our request,
the Office of Human Research Protection, an investigative arm of
the National Institutes of Health, launched a full scale investigation
of those in charge at Columbia. After more than two years, the OHRP
determined that the Columbia staff had inappropriately approved
42 of the total of 62 patients entered into the study. Despite the
inappropriate entry of so many patients into the nutrition arm,
as it turns out the longest survivors appear to have been our patients.
I have written a full length book about the project, which hopefully
will be available within six months.
In addition to these clinical trials, we have collaborated with
basic science researchers to test our enzyme approach in animal
models of pancreatic cancer. In May, 2004, the results of these
studies were published in the peer-reviewed journal Pancreas.
In these experiments, a very aggressive form of pancreatic cancer
was induced in mice, then half the animals were given our enzymes,
half were given no therapy. Those treated with the enzymes showed
a significant improvement in survival and behavior compared to animals
not receiving the enzymes. In a second experiment, tumor growth
was substantially reduced, and survival prolonged again, in animals
receiving the enzymes. (13) (Abstract of article
on enzyme therapy in mice) We want to emphasize that the results
were particularly significant for a first attempt, since the investigators
were using only the enzyme part of our program, and did not use
a variety of doses to determine the most optimal for a mouse. As
the principal investigator of the study wrote in the conclusion
of the article: "In summary, PPE (porcine pancreatic enzyme)
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 on physical condition, nutrition and lack of
toxicity."
In addition to the financial support from Nestle, from 1995-1998,
Procter & Gamble invested considerable resources helping us
refine our therapy. You can review statements
of support from Pierre Guesry, M.D., former Vice President for
Research at Nestle, and J.P. Jones, Ph.D., the retired Vice President
for Health Care at P&G.
In January 2007, we published a lengthy article about our results
with enzyme
therapy in the peer reviewed journal Alternative Therapies
in Health and Medicine. (14) Here, we discussed 36 patients
diagnosed with a variety of advanced and poor prognosis cancer who
responded to our treatment with exceptional survival and in many
cases evidence of tumor reduction. We intend eventually to publish
in book form 100 such cases, with supporting medical documentation.
Please subscribe to our announcement list
for updates on book projects currently in progress.
We also want to emphasize that in our practice we prescribe, and
in the pilot study and in the animal experiments we used a formulation
of pancreatic proteolytic enzymes made to our strict specifications.
These enzymes are available only to our patients, and are not available
over the Internet or in health food stores. In our experience, quality,
manufacturing methods, and composition vary widely among commercially
available preparations of proteolytic enzymes. The results of our
studies cannot be used as validation for any other product, whether
obtained from a health food store, a pharmacy or an Internet source.
Although our published research deals with pancreatic cancer, in
our office we treat patients with all types of cancers. We
also treat patients with a variety of other problems, ranging from
chronic fatigue syndrome to multiple sclerosis. Each treatment
protocol is individualized for each patient, regardless of the underlying
problem.
The therapy itself is quite complex, but basically involves three
components: diet, aggressive supplementation with nutrients and
enzymes, and detoxification. The protocols are individualized and
each patient receives a diet designed for his or her specific needs.
The diets are quite variable, ranging from a pure vegetarian program
to a diet requiring fatty red meat 2-3 times a day.
The supplement regimens are also individualized, and intense: each
cancer patient consumes between 130 and 175 capsules daily. Non-cancer
patients will require considerably fewer supplements per day. The
supplement regimens include a range of vitamins, minerals, trace
elements, anti-oxidants and animal glandular products, prescribed
according to the particular patient's needs and cancer type. These
nutrients do not, we believe, have a direct anti-cancer effect,
but instead serve to improve overall metabolic function. In addition
to these supplements, every cancer patient takes large quantities
of enzymes in capsule form, which we believe provide the main anti-cancer
action.
The animal glandular products and proteolytic enzymes that we
use are derived from animals raised in Australia and New Zealand,
where there has been no history of BSE (mad cow disease) or other
prion diseases such as scrapie. The animal husbandry regulations
in Australia and New Zealand are the strictest in the world, and
prohibit the feeding practices that have caused problems in other
countries.
The third component of the protocol involves what we call "detoxification"
routines. On this therapy, we find that as patients repair and rebuild,
large amounts of metabolic wastes and stored toxins are released.
As a result, patients routinely develop a variety of symptoms, most
commonly described as "flu-like," such as low grade fevers,
muscle aches and pains, even rashes that we hypothesize result from
low grade tumor lysis. "Detoxification" refers to procedures
such as the coffee enema, which are believed by alternative practitioners
to enhance liver function and in turn, the processing and excretion
of metabolic wastes. The coffee enemas are done twice daily, and
patients most commonly report symptomatic relief.
Coffee enemas have been discussed in the orthodox medical literature
for the better part of this century. Many nursing texts routinely
recommended coffee enemas (15), and the Merck Manual advocated coffee
enemas as a stimulant in all editions from the first in 1898 through
1977. During the 1920's and 30's, coffee enemas were prescribed
for a variety of conditions. (16-20) In terms of their physiological
effect, studies have shown that the rectal instillation of fluids
will stimulate gallbladder contraction and emptying. (21)
Of the hundreds of Kelley patients I interviewed during my research
study, virtually every one reported significant symptomatic relief
from the enemas. In my own practice patients repeatedly report the
same improved well-being and relief of symptoms after a coffee enema.
The enemas, in my experience, appear to be safe: I have yet to document
a single serious side effect either in the thousands of Kelley patients
I evaluated, or in my own practice. However, I do not encourage
anyone to attempt coffee enemas except under the care of a knowledgeable
physician.
Our goal remains to have our approach properly tested in an academic
environment, and should the results continue to prove positive,
to have our work mainstreamed into the orthodox medical world.
(For further information, you may wish to order a lecture
recording. Recordings of lectures given by Dr. Gonzalez over
the years to both lay and professional groups are available, and
provide more intensive explanations of the program. Various audio
recordings of Dr. Gonzalez are available
on this web site.) For periodic updates about our work and our website,
please subscribe to
our mailing list.
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