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Abstract
Introduction: Dr. Kelley developed the Kelley Nutritional-Metabolic Cancer
Program in the 1960s which involves four major components: pancreatic enzymes,
nutrition, detoxification and spirituality. The Kelley Program defines cancer
according to Dr. Beard's theory that states that cancer is a normal,
necessary part of life.
Components of the Kelley Program: The pancreatic enzymes are the anti-tumour
element of the program. Studies conducted in animals demonstrated that enzyme
treatment has an anti-tumour effect. Several case reports documented tumour
regression and even remission in terminal cancer patients treated with pancreatic
enzymes. Enzyme treatment in conjunction with conventional therapy has been
shown to be beneficial. The diet and supplements are designed to provide a
supportive role for the patient's body. One study demonstrated that the
5-year survival rates of those patients who employed the nutritional therapy
and detoxification were considerably higher than those reported elsewhere.
The patients perform detoxification with coffee enemas in order to eliminate
toxic materials from the body and to alleviate pain. The Kelley Program prescribes
having faith and encourages patients to pray. Many researchers have reported
that religiosity and spirituality are associated with enhanced health and well-being
as well as decreased mortality.
Conclusion: Many studies have shown that each component of the Kelley program
has some effectiveness at treating cancer. There are also studies that support
Beard's original theory of cancer. Therefore, further investigation of
the Kelley program is definitely necessary to evaluate its effectiveness as
a whole, which includes all 4 components, in order to properly prove or disprove
this cancer treatment.
Introduction
Dr. William Donald Kelley, an orthodontist from Washington State, developed
the Kelley Nutritional-Metabolic Cancer Program in the 1960s. In the 1960s
Dr. Kelley was diagnosed with pancreatic cancer, he developed this program,
cured himself and is still alive today, forty years later. He then taught
other cancer patients his program, which has had phenomenal results leading
to complete cures in many cancer patients. In 1970, Dr. Kelley was convicted
of practicing medicine without a license and in 1976 a court suspended his
dental license for five years. Despite his hardships with conventional medicine,
he continues to help cancer patients by teaching them his program.
The Kelley Program is a collaboration of various natural cancer treatments
into one. It includes 4 major components: pancreatic enzymes, nutritional therapy,
detoxification and spirituality. The program prescribes that all four components
be employed by the client in order to achieve maximum benefit.
Cancer is a highly prevalent disease. In the United States each year over 1
million individuals learn for the first time that they have some type of cancer
(Cotran et al, 1999). People living in the United States have about a one in
five chance of dying of cancer. There were about 564,000 deaths from cancer
in 1998 representing 23% of all mortality. Only cardiovascular diseases cause
more deaths than cancer.
Cancer as Defined by Allopathic Medicine
In allopathic medicine, cancer is defined as a fast growing malignant tumour,
which, if allowed to grow unchecked, will cause death. Cancer is a proliferation
of cells, whereby there is a loss of normal control resulting in unregulated
growth, lack of differentiation, local tissue invasion and metastasis. Cancer
can develop in any tissue of any organ at any age. Generation time is the
time it takes for cells to enter the cell cycle and give rise to two daughter
cells. Malignant cells usually have a shorter cycle than non-malignant cells.
As the tumour grows, nutrients are provided by direct diffusion from the
circulation. Metastases develop when tumour cells adhere to vascular endothelium
and penetrate into surrounding tissues, surviving and spawning independent
tumours at distant sites (Beers and Berkow, 1999).
The allopathic medicine theory on cancer believes that mutations in genes are
partially responsible for the growth or reproduction of malignant cells. These
mutations alter the quantity or behaviour of the proteins encoded by growth-regulating
genes and alter cell division (Beers and Berkow, 1999).
In most neoplasms (any abnormal growth of new tissue) the parenchymal cells
bear a close resemblance to each other, as though they were all derived from
a single cell. Infrequently, divergent differentiation of a single line of
parenchymal cells creates what are called mixed tumours. The great majority
of neoplasms, even mixed tumours, are composed of cells representative of a
single germ layer (Cotran et al, 1999).
Cancer as Defined by the Kelley Program
The Kelley Program defines cancer according to Dr. Beard's cancer theory.
Dr. John Beard (1858-1924), a Scottish embryologist, theorized that cancer
is identical to the trophoblast. Cancer is an irresponsible trophoblast (Beard,
1905). In this respect cancer is a normal, necessary part of life (Beard, 1911).
In the first 5 days after fertilization in the formation of a human embryo,
the growing mass of cells divides into two kinds of cells, an inner cell mass
(embryoblasts), which becomes the embryo, the sexual generation, and an outer
layer of cells called the trophoblast, the asexual generation, which later
becomes the placenta. The trophoblast forms the primitive germ cell, which
grows, doubling many times. After the cell mass attaches to the wall of the
uterus, the trophoblasts invade the lining of the uterus, growing quickly and
invasively. The trophoblast cells invade and digest a hole in the wall of the
uterus and form a multinucleated mass with no cell boundaries. As the small
blood vessels are invaded and digested by the invading trophoblasts, pools
of blood form in the tissue, which nourishes the growing mass (Beard, 1911).
While the trophoblast cells are infiltrating the maternal tissue, the inner
cell mass becomes three germ cell types; the ectoderm, the endoderm and the
mesoderm, which organize themselves to become the vast majority of cells of
the body. The mesodermal cells are pleuripotential, with a vast ability to
become many different kinds of cells. Some of these cells remain "sleeping," dispersed
throughout the tissues of the body (Kelley, 2000).
When these "sleeping" pleuripotential cells are activated through
genetic, environmental or nutritional factors, a tumour mass similar to the
invasive trophoblast cell mass can begin to form (Kelley, 2000). The trophoblast
cells (cancer cells) now trapped outside of the uterus, grow rapidly, trying
to form a placenta (a malignant mass) (Beard, 1911). The trophoblast cells
grow rapidly and uncontrollably, having the ability to invade (metastasize)
the wall of the mother's uterus to form the cancer mass (placenta). This
cancer mass first opens a blood supply to the embryo for nourishment and second,
firmly attaches (metastasizes) the placenta (with its blood supply to the walls
of the uterus) to protect the embryo from falling out of the uterus. Malignancy,
therefore, is not normal tissue that has gone into wild proliferation, but
rather normal trophoblastic tissue that is growing in the wrong place at the
wrong time (Kelley, 2000).
Support for Beard's Cancer Theory
One critique of the Kelley program claims that Dr. Beard's theory on
cancer is a turn-of-the-century (1900) idea that conflicts with established
facts about cancer causation and etiology confirmed by research done over the
past 50 years (Green, 1998). This is not the case, as there is recent scientific
support for Dr. Beard's theory.
If, according to Beard, all human cancer is trophoblastic in origin, one might
expect them to express human chorionic gonadotropin (hCG); hCG is the standard
hormonal marker of pregnancy and the standard hormonal marker of germ cell
tumours. In 1994, scientists showed that cancer cells express hCG in all its
forms (Krichevsky et al, 1994). Researchers showed that the "synthetic
hCG…is a common biochemical denominator in cancer" (Acevedo et
al, 1995). It was demonstrated that there was the presence of hCG, its subunits,
and /or fragments, in 85 different cancer cell lines. Acevedo consistently
found hCG in human malignant tumour tissues. He concluded that hCG, the hormone
of pregnancy and development that also has chemical and physiological properties
of growth factors, is a common phenotypic characteristic of cancer. Acevedo
stated that after a century, "Beard has been proven to be conceptually
correct" (Avecedo et al, 1995).
Regelson (1995) wrote in an editorial that hCG defines the metastatic aggressiveness
of the tumours in which it is found. Neither non-embryonic cells nor benign
tumour cells express hCG, but hCG-beta is a defining phenotype statement of
malignant transformation.
An oncologist wrote that pregnancy and cancer are the only two biologic conditions
in which antigenic tissue is tolerated by a seemingly intact immune system.
The trophoblastic tissue has all the characteristics of true cancer; it is
deeply invasive, it is highly anaplastic in morphology, it has a high mitotic
index, and it produces oncofetal antigens. In every respect, it behaves as
a true cancer (Lentz, 1990).
In 1902, Beard described the role of "totipotent germ cells" in
the development of cancer. In embryology, the word "totipotent" means
a cell is capable of giving rise to all types of differentiated cells found
in that organism. "Totipotent germ cells" are analogous to human
embryonic stem cells (ESC), which were not isolated until 1998. Human ESCs
are described as totipotent and in fact, they release hCG (Thomson et al, 1998).
Allopathic medicine believes that cancer is caused by such things as viruses,
X-rays, cigarette smoking chemicals, sunlight, and trauma (Cotran et al, 1999).
A number of cancer researchers believe that these factors, rather than causing
cancer, are indirect stimulators of a normal trophoblast-like pleuripotential
cell (Kelley, 2000).
Components of the Kelley Program
1) Pancreatic Enzyme
Treatment
The Kelley program prescribes that each patient take large amounts of pancreatic
enzymes daily, taken with and away from meals and spread evenly throughout
the day. The pancreatic enzymes are the anti-cancer element of the program.
The idea of treating cancer with pancreatic enzymes was introduced by Dr.
Beard.
In 1906, Dr. John Beard claimed that pancreatic proteolytic enzymes represent
the body's main defence against cancer and would be useful as a cancer
treatment. Continuing on Beard's trophoblast theory of cancer, he explained
that what normally stops the trophoblast from being invasive is the presence
of pancreatic enzymes of both the embryo and the mother. Pancreas functions
throughout fetal life in a mammal though it has nothing to digest except the
trophoblast. Nature itself has possibly provided a remedy for cancer through
digestion of the trophoblast in the secretion of that important digestive gland,
the pancreas (Beard, 1905).
These pancreatic enzymes travel to the tumour and only digest the cancer, without
harming the person's body in which the cancer is growing. Beard explained
that the secret to how the enzymes can tell the difference between self (healthy
cells) and non-self (tumour cells) lies in the difference in left and right
handed molecule configuration. It is known that trypsin acts on cooked left-handed
proteins and living (non-cooked) right handed proteins. Proteins that we eat
are broken down in the small intestine by trypsin that is released by the pancreas.
Trypsin does not act on the organs of the human body because these are living,
left-handed proteins. However, trypsin is very effective at breaking down living,
right-handed proteins (Beard, 1911). The cancerous tumour is made up of living,
right-handed proteins. The trypsin travels via the bloodstream to the tumour,
and its action there is on the protein mass that makes up the tumour (Kelley,
2000). The cancerous tumour makes an enzyme that digests organs and tissues
of the human body as its food. This tumour-made enzyme is called malignin,
which is the mirror image of trypsin. Trypsin will only digest the protein
of the tumour (Beard, 1911), the enzymes can then safely travel throughout
the body (Kelley, 2000).
Beard believed that the enzymes had to be injected to prevent destruction by
hydrochloric acid in the stomach (Beard, 1911). However, recent evidence demonstrates
that orally ingested pancreatic proteolytic enzymes are acid stable (Moskvichyov,
Komarov and Ivanova, 1986), pass intact into the small intestine and are absorbed
through the intestinal mucosa into the bloodstream as part of an enteropancreatic
recycling process (Gotze and Rothman, 1975, Liebow and Rothman, 1975).
Studies on Enzyme Treatment Effects
There are some studies that have examined the effects of enzyme treatment on
cancer, as researchers understand it today. These studies demonstrate that
enzyme treatment has an effect on cancer markers, antibody production and
the immune system.
The adhesion molecule CD44 and variants of the molecule on tumour cells are
involved in the process of tumour progression and metastasis (Gebauer et al,
1997). One study investigated the effects of the proteases (bromelain, papain,
trypsin, and chymotrypsin) on the density of CD44 molecules present on human
leukemia Molt 4/8 cells (Harrach, 1994). The protease bromelain was found to
be most active in reducing CD44 receptor density. These findings implicate
the possibility of the anti-metastatic activity of orally administrated bromelain
with respect to CD44.
Another study investigated the ability of several
proteolytic enzymes to modulate the CD44 molecule on different tumour
cell lines (Gebauer
et al, 1997). They found that proteolytic enzymes like bromelain, papain,
and chymotrypsin were able to modulate CD44 on cells of leukemic origin,
as well
as on melanoma and mammary carcinoma cell lines. These results imply that
treatment with proteolytic enzymes might be useful in reducing the
metastatic behaviour
of malignant cells. Wald et al (2001) also found a correlation with a decreased
expression of CD44 and CD54 molecules in tumours exposed to proteolytic enzymes
in vivo.
In one study, the experimental group of Swiss mice had a 260% increase in
antibody production with the addition of 2% pancreatin to the diet, which
indicated
an immune enhancement effect for orally ingested pancreatin (King, 1965b).
Another study on humans demonstrated that a proteolytic agent increased the
T-cell counts significantly and this was most marked in older age groups
and the patients with malignant disease (Holland et al, 1975), indicating
that
proteolytic enzymes may have an immune enhancing effect. Animal Studies on Enzyme Treatment
Beard (1906) conducted research to determine the action of trypsin upon the
living cells of Jensen's mouse-tumour. After 10 days, one trypsin mouse
was found dead and post-mortem examination revealed no cause of death. The
lab attendant thought the mouse got caught between the cage and the food
vessel and caused its own death. The microscopic examination of the trypsin
mouse demonstrated that every single cell of the tumour was in degeneration.
After 22 days of treatment one of the control mice died of its tumour and
the second trypsin mouse was killed for microscopic exam. Upon examination,
the skin around the trypsin mouse's tumour was in necrosis. The tumour
in the control mouse was as large as the terminal phalanx of a man's
thumb, while in the second trypsin mouse the tumour was the size of a lentil
and was in advanced degeneration (Beard, 1906).
Recent studies on animals with tumours treated with enzymes reveal similar
results to Beard's studies, thus supporting Beard's theory on cancer.
In 1965, a researcher reported complete prevention of tumours in a group of
C3H mice carrying Bittner's milk factor virus that received oral pancreatin
compared with 100% tumour occurrence in the control group (King, 1965a).
In a study using C57B16 mice with the Lewis lung carcinoma, in the control
group, which received no enzyme treatment, 90% of animals died of the metastatic
spread of cancer by day 18. The treated groups A (received the enzymes from
the time of primary tumour extirpation), B (received the enzymes from 6 days
before primary tumour extirpation) and C (received the enzymes from 24 hours
after intracutaneous tumour inoculation) showed survival rate 60%, 90% and
100% of animals, respectively, by 100 days (Wald et al, 1998a).
The influence of proteolytic enzyme mixture was tested on spontaneous lymphoblastic
leukemia development in an in vivo experiment in rat species SD/Ipcv. In the
group treated by a mixture of trypsin, chymotrypsin and papain a significantly
lower rate of blast cells in the peripheral blood during disease development
was noticed. The average survival time in the experimental group was 150 days
(50% surviving until the end of the experiment, 366 days), while the control
group was 43 days (none surviving until the end of the experiment) following
the appearance of the first blast cells. The proteolytic enzyme mixture has
also had a positive influence on the stable weight gain in animals in contrast
to the weight loss of the control group in the terminal stage of the disease
(Wald et al, 1998b).
This study investigated the effects of a mixture of proteolytic enzymes on
C57BI6 mice with syngeneic melanoma B16. The results show that administration
of proteolytic enzymes to mice inhibited the growth of primary tumours, tumour
recurrences were less numerous and metastasis was considerably curtailed both
in the vicinity of the primary tumour and at distant locales. The results demonstrate
that the enzyme mixture is capable of inhibiting B16 melanoma tumour growth
and metastasis in mice (Wald et al, 2001).
This study investigated the influence of protease mixture in mice transplanted
with human pancreatic carcinoma. The test group was administered a trypsin,
chymotrypsin and papain solution, while the control group was administered
saline. In the study, it was found that the protease mixture retards growth
of human pancreatic adenocarcinoma in mice. These results confirm growth inhibition
of primary tumour by trypsin, chymotrypsin and papain solution (Wald et al,
1999).
The thiolprotease bromelain, isolated from pineapple stem, was suggested for
use in adjuvant tumour therapy. In vitro treatment of the melanoma cells with
bromelain F9 and papain injected into mice prevented lung colonization. The
proteases inhibited growth of the melanoma cells in a dose dependent manner.
The proteases reduced the invasive capacity of the melanoma cells maximally
by about 30%. Crude bromelain was most active in abolishing the CD44 re-expression
after protease treatment (Grabowska et al, 1997).
Studies conducted on animals treated with enzymes revealed surprising results.
The preceding studies demonstrated that enzyme treatment has an anti-tumour
effect. It is important to note that even though studies on animals are able
to exemplify the potential benefits for humans, the results are never completely
transferable to humans.
Case studies on Enzyme Treatment
Several case reports in the medical literature documented tumour regression
and even remission in terminal cancer patients treated with pancreatic enzymes.
A 23-year-old woman was diagnosed with multiple fibrosarcoma of the tongue,
and after multiple surgeries and reoccurrences of the tumours the case was
considered practically a hopeless one. As a last resort the doctor decided
to administer trypsin and pancreatic extract based on work he had read by Dr.
Beard. Soon after the administration of trypsin and the pancreatic extract
the tumours ceased to increase in size and after the doses increased, the tumours
slowly began to decrease in size. The tumours were barely perceptible to the
touch, the patient was able to speak distinctly for the first time, the patient's
general health improved greatly, and she gained 11 pounds in weight. At this
stage, at the patient's request, the treatments were discontinued. Upon
examination three months later the growths had increased in size, the patient
was depressed mentally and refused any further treatment (Wiggin, 1906).
A 56-year-old man was diagnosed with malignant disease involving the left tonsil,
base of tongue and epiglottis, which was deemed inoperable. The patient was
failing rapidly and nothing better could be suggested, so they decided to try
trypsin injections. Upon starting the enzyme treatment, the submaxillary gland
rapidly decreased in size. The patient was swallowing more comfortably, feeling
much better and had gained 3 pounds. The patient says that he feels well and
believes that he is cured. Unfortunately, in this case, the initial diagnosis
was clinical only (Campbell, 1907).
A 65-year-old man had a rapidly growing abdominal tumour. He was told that
nothing further could be done for him surgically. Cutfield treated this patient
with injections of trypsin and amylopsin as recommended by Dr. Beard. The patient
began to improve steadily. The vomiting, nausea and flatulence disappeared,
his appetite improved, gradually the pain lessened, the swelling steadily diminished
and his weight regularly increased. The only symptom left was some abdominal
discomfort and occasional pain. He eats and sleeps well and attends to his
business regularly and his weight is only a few pounds less than it had been
for many years. Cutfield does not claim that this patient was cured but does
state that there is no doubt of the immense improvements, especially considering
how rapidly the patient was deteriorating before the treatment commenced and
how promptly and steadily the improvement took place after the treatment began
(Cutfield, 1907). Cutfield wrote that, it is extremely difficult to believe
that the trypsin was not the cause of that improvement.
Goeth wrote about 4 cases. In case 1 the patient was a man with a large vascular
sarcoma on the side of the neck. The patient left Goeth's care in order
to be operated on by another physician and died during surgery. In case 2 the
patient was an elderly woman with cancer in both breasts and secondary cancers
in glands on one side of her neck. She showed no improvement under the trypsin
treatment and the treatment was discontinued for some time before her death.
In case 3 the patient was a woman a little over 70 years old with cancer in
the face, which had destroyed one eye. At first the trypsin treatment increased
the lesion in her face. After a month, Goeth started alternating injections
of amylase and trypsin and the patient began to improve at once, the lesion
in the face began to heal rapidly until the eye cavity and the rest of the
wound had a healthy skin over it. Also, her general health improved markedly
and now she is able to do light housework. In case 4 the patient was a woman
with cancer in one breast with secondary nodules in both axillae and around
the diseased breast. At the start of the trypsin treatment every gland infected
with cancer became inflamed and painful and the tumour mass was sloughing away
rapidly. Goeth changed to alternating injections of amylase and trypsin and
the pain was greatly reduced and her general health is improving daily. The
microscopic findings revealed that the cancer cells were broken up so that
it was difficult to find an entire cancer cell and the stroma of connective
tissue was as intact and uninjured. Therefore, Goeth concluded that the pancreatic
treatment attacks the cancer cells only (Goeth, 1907).
Though case studies cannot, by themselves, prove that a method of treatment
works, it does help to support the enzyme treatment for cancer, especially
since different physicians observed results in cases that were treated in isolated
situations.
Unfortunately, Beard's theory became largely forgotten in the medical
community and further clinical studies were not conducted. This was largely
due to the fact that other physicians were unable to consistently reproduce
Beard's work. Though, Beard believed these failures were due to commercially
available enzymes being variable in quality and inadequate doses being administered
to patients. Due to the lack of reproducible results, interest in his ideas
virtually disappeared.
Enzyme Treatment as Complementary Therapy
Recent articles have examined the effects of using enzyme treatment with the
conventional cancer treatments of chemotherapy and radiation.
In this randomized prospective clinical trial, oral enzyme therapy was given
additionally with radiation to abdominal cancer patients and compared with
radiation only. The coupled oral enzyme therapy improved the tolerance of the
radiation significantly. The enzyme-treated patients had less deterioration
of the it reduced the number of drugs needed for the treatment of radiation
adverse effects (Stauder et al, 1991).
The remission time of multiple myeloma patients after chemotherapy and after
enzyme-chemotherapy were compared retrospectively. Enzyme-chemotherapy prolongs
remission times in stage II multiple myeloma patients and reduces the concentration
of progression markers, soluble TNF-receptors and ß2-microglobulin (Desser
et al, 1997).
Existing data was assessed on patients with multiple myeloma (stages I-III)
treated with chemotherapy alone vs. chemotherapy and additional treatment with
oral enzymes (OE). In the OE group for all disease stages had longer median
survival times. Response rates are higher and duration of remission is longer
in the OE group. OE decreased the estimated mortality risk by 50% to 60% (Sakalová et
al, 1998).
The results of these studies indicate the beneficial effects of using enzyme
treatment in conjunction with conventional therapy. This also exemplifies the
need for further studies on treating patients with enzyme treatment only, in
order to discover if the noted improvements were due to the enzyme treatment
alone or enzyme treatment in combination with chemotherapy or radiation.
Nutritional Therapy
The Kelley program prescribes a diet that is tailored to each individual. In
general the diet emphasizes fresh raw fruits, raw vegetables, and freshly
made vegetable juices daily. The diet encourages plant-based protein sources
such as cereals, nuts, seeds and whole-grain products. The diet allows one
or two eggs daily, but forbids animal proteins, specifically red meats and
poultry, processed foods, pesticide residues, milk, soy beans, peanuts, food
concentrates, white sugar and white rice. The diet is designed to provide
a concentrated supply of nutrients in their natural form with all the associated
co-factors. The supplement regimen includes vitamins, minerals and trace
elements. Organ, such as thymus and liver, derived from beef or lamb are
also prescribed to provide a concentrated source of nutrients. The diet and
supplements are designed to provide a supportive role for the patient's
body.
In the 1930s, Dr. Max Gerson (1881-1959) designed a cancer treatment that includes
nutritional therapy and detoxification using coffee enemas. The Kelley Program
and the Gerson Program are very similar with respect to the nutritional therapy
and detoxification, the one main exception is that the Kelley program includes
the addition of pancreatic enzymes to the regimen. Therefore, examining the
Gerson program provides a way to isolate and analyze the nutritional therapy
and detoxification components of the Kelley Program.
The Gerson diet requires that patients eat mainly a raw vegetarian diet, drink
freshly prepared vegetable and fruit juices and do coffee enemas. Other key
elements of the diet include salt restriction, potassium supplementation, extreme
fat restriction, temporary protein restriction, iodine and thyroid administration
(Lerner, 1994). Gerson restricted calories while simultaneously increasing
metabolism in an effort to emulate the anti-tumour effect of calorie restriction.
Enhanced calorie utilization rates can alter tumour growth, whether metabolism
is accelerated by iodine medication or exercise (Moreschi, 1909, Rous, 1914).
Gerson's regimen also included taking coffee enemas for detoxification.
Gerson felt that in order for the body to heal itself, the body needs to be
detoxified (Lerner, 1994). Enemas were taken as needed for their observed ability
to alleviate pain and to improve nutritional conditions.
Studies on Gerson's Therapy
In a retrospective review of the 5 year survival rates of melanoma patients
treated by Gerson's diet therapy, it was found that of the patients
with stages I and II (localized) melanoma, 100% were alive at 5 years; of
the patients with stage IIIA (regionally metastasized) melanoma, 82% were
alive at 5 years; of the patients with combined stage IIIA and IIIB (regionally
metastasized) melanoma, 70% were alive at 5 years and patients with stage
IVA (distant lymph, skin, and subcutaneous tissue metastases), 39% were alive
at 5 years (Hildenbrand et al, 1995a). The 5-year survival rates were considerably
higher than those reported elsewhere.
One retrospective study found that survival rates were more than double for
self-selected melanoma patients who employed surgery along with Gerson's
diet therapy when compared with those who relied only on non-surgical treatment
(Hildenbrand et al, 1995a). A critique of this study pointed out that the control
group were matched patients who refused the therapy, which was basically a
flawed control group (Lerner, 1994).
In another study, a research team visited Gerson's Clinic in 1989 and
examined cases selected by the Gerson Institute (Weitzman, 1998). The researchers
found little objective evidence of an anti-tumour effect. However, in a few
patients, definite tumour regression was seen. There was subjective benefit
to the patients and their families. The patients felt that they had control
over their health, had high ratings for mood and confidence, with low pain
scores and analgesic requirements, despite extensive metastatic disease.
Lechner and Kronberger (1990) have observed improved tolerance of aggressive
conventional treatments in patients who employed Gerson's therapy at
the same time. There is evidence that psychological well-being is associated
with a better response to conventional therapy and the nature of the Gerson
and other dietary therapies "require an active contribution by patient
and family to his state of health and meets a need not satisfied by conventional
therapy." (Reed et al, 1990) Pain control appeared to be better with
Gerson's patients (Lerner, 1994). Gerson's patients lived longer,
were healthier, and had better responses to conventional therapies with fewer
side effects, less pain and a better quality of life. It must be remembered,
however, that the psychological characteristics of patients who will undertake
and remain on this type of therapy may play a part in these results (Weitzman,
1998).
The evidence for the efficacy of the Gerson diet remains questionable and a
review by an expert panel found the Gerson diet to be "ineffective in
curing cancer" (American Cancer Society, 1990). It appears that the Gerson
diet, by itself, does not result in cure for any type of cancer, but that the
diet may act as an adjunct to conventional cancer treatment, allowing for greater
well-being and quality of life (Weitzman, 1998).
In terms of the Kelley Program, it must be emphasized that the nutritional
component of this regimen plays a supportive role for the body and is not believed
to be the anti-tumour component of the program. Therefore, the studies that
indicate that the Gerson diet alone does not cure cancer do not act to disprove
the Kelley program.
Detoxification
The Kelley Program prescribes that patients perform detoxification with coffee
enemas at least once a day. Coffee enemas have been discussed in the orthodox
medical literature for the better part of this century (Gonzalez and Isaacs,
1999). Coffee enemas were prescribed for a variety of conditions, which proved
to be effective after failure to improve following the usual forms of medical
treatment (Snyder, 1939).
The reasoning behind conducting detoxification techniques is because the enzymes,
in sufficient quantities, can begin to break down the cancerous tumour, and
during this process some intermediate proteins are produced and abnormal molecules
of the tumour waste are released into the blood, which can be quite toxic to
the human body (Beard, 1911). These toxic substances must be eliminated and
are done so by laxatives such as epson salts and coffee enemas (Kelley, 2000).
These toxic substances are filtered and detoxified by the liver. They are excreted
through the bile ducts from the liver to the small intestine. The walls of
the bile ducts are composed of smooth muscle that the caffeine in coffee causes
to relax, causing the duct to open wide, allowing tumour toxins to pass into
the small bowel. Research shows that the administration of coffee enemas does
appear to cause biliary-duct dilatation and increased bile excretion (Lerner,
1994). The enemas act to lavage and thoroughly cleanse the walls, remove abnormal
mucus and also empty the bowel. The tone of the colonic muscles is improved
and the blood supply augmented (Friedenwald and Morrison, 1935). By cleaning
out the colon, the system is afforded relief from toxic products and an unnecessary
burden is removed from metabolic processes (Marshall and Thompson, 1932). The
coffee enemas have also been found by many patients to alleviate pain (Kelley,
2000).
Spirituality
The Kelley Program prescribes having a spiritual attitude and having faith.
Mind/Body medicine attempts to use thought patterns to influence both the
perceptions of health and the course of illness (Benson and Dusek, 1999).
Many mind/body techniques, including progressive relaxation, autogenic training,
Zen, yoga, meditation and some forms of prayer often elicit a physiological
response termed the "relaxation response" (Benson et al, 1974a).
The relaxation response is characterized by decreased metabolism, heart and
respiratory rate, responsivity to plasma norepinephrine, lowering of systolic
and diastolic blood pressure and slowing of alpha, theta and delta brain
waves (Benson et al 1974b, Hoffman et al, 1982, Morrell and Hollandsworth,
1986, Wallace et al, 1971). Spiritual healing is one mind/body approach in
widespread use by certain religious groups (Galanter 1997, Levin et al, 1997,
Roush, 1997) and may elicit the relaxation response through prayer (Benson,
1996).
Many have reported that religiosity and spirituality are associated with enhanced
health and well-being (Ellison, 1991; Ellison and Levin, 1998; Koenig et al,
1988, 1998; Idler and Kasi, 1997) as well as decreased mortality (Bryant and
Rakowski, 1992; Goldman et al, 1995; Oman and Reed, 1998; Schoenbach et al,
1986; Seeman et al, 1987). Others (Sloan et al, 1999) however, assert these
associations are not conclusive.
Gonzalez' Research
In 1981, Dr. Nicholas Gonzalez began researching the use of pancreatic proteolytic
enzyme therapy as a treatment for cancer (Gonzalez and Isaacs, 1999). He
conducted an intensive retrospective review of 1306 patients who had been
treated over a 20-year period by Dr. Kelley who used enzyme therapy, diet
and nutritional support. This study included a review of pancreatic cancer
patients, some of whom survived in excess of 5 years (unpublished).
Gonzalez concluded, "A study such as mine cannot, of course, prove conclusively
that Kelley's treatment cures cancer, since the patients who were evaluated
were not treated under controlled conditions. Nevertheless, significant number
of patients with appropriate diagnosed terminal cancer enjoyed impressive regressions
of the disease while on the Kelley regimen. This finding alone warrants a full,
fair and unbiased investigation of Kelley's methods."
In June 1993, Gonzalez presented a selection of cases from his own practice
at the National Cancer Institute (NCI) as part of an NCI effort to evaluate
non-conventional cancer therapies. He was encouraged by the NCI to do further
studies. In 1999, he published a 2 year, unblinded, 1 treatment arm, 10 patient,
pilot prospective case study that was used to assess survival in patients suffering
inoperable stage II-IV pancreatic adenocarcinoma treated with large doses of
orally ingested pancreatic enzymes, nutritional supplements, detoxification
procedures and an organic diet. After 1 year 81% had survived, 45% survived
2 years, and 36% survived for 3 years (Gonzalez and Isaacs, 1999). These results
are far above the 25% survival at one year and 10% survival at two years for
all stages of pancreatic adenocarcinoma reported in the National Cancer Data
Base from 1995 (Niederhuber, Brennan and Menck, 1995). Following this publication,
Gonzalez was given a grant of $1.4 million from the National Cancer Institute
for a larger prospectively randomized trial.
It must be noted that the Gonzalez program is very similar to the Kelley Program,
but not identical. The Gonzalez program has dispensed with the spirituality
component. The Gonzalez program also allows animal proteins in the initial
stages of the program, whereas the Kelley program absolutely forbids animal
proteins in the initial stages of the program. This is because Kelley believed
that one of the contributing causes of the tumours are due to the decreased
efficiency of the body to break down proteins. Therefore, the Kelley program
prescribes that all allowed proteins (grains, nuts, glandulars, eggs) be eaten
before 1pm in order to give the body ample time to break down these proteins.
Studies conducted on the Gonzalez program will give the scientific community
insight into the efficacy of the Kelley program.
Discussion
Upon hearing about this program, some wonder if there exists an element of
self- selection within the patient pool or if the patients are affected by
individual motivation. It is important to understand that the Kelley program
is not an easy program to follow. The Kelley program is a very comprehensive
program and involves total commitment, active involvement by the patient
and family, significant lifestyle changes, dedication and hard work. I would
venture to say that there is definitely an element of self-selection and
there is no doubt that this program involves individual motivation by the
cancer patient. People would not commit to this program if they did not believe
that it would work and if they did not have the drive to survive. The success
of this program can be partly attributed to positive expectations, but it
is probably not the only reason that this program works.
Some critics say that there is no proof that this program is any better than
a placebo effect. Within the medical community the term ‘placebo effect' has
a very negative connotation. With the Kelley program the client has complete
control over their health. The Kelley program is a self-empowerment program.
It involves being taught the method to heal yourself. The program works to
activate the healing powers within each client. Therefore, this program is
not eliciting the placebo effect; in contrary, it is empowering the patient
and giving them control over their healing.
The large number of required supplements vitamin/mineral may lead to toxicity
and nutrient/nutrient interactions. Colonics and diuretics may cause an imbalance
of the various nutrients in the body. Not enough information exists to prove
that the cancer treatment program is safe or helpful (Biological Based Systems,
2002). Though this is a worthy caution, the last statement of this critique
must be emphasized, because not enough information does exist to prove or disprove
the program, but in most cases supplements of vitamins and minerals that act
to support the body are more beneficial in comparison to numerous pharmaceutical
drugs prescribed by allopathic medicine.
A critique of the Kelley Program states that "a review of all the material
published by Kelley and Gonzalez shows neither to have had training in oncology
or board certification in any medical specialty or to have performed or published
experimental work verifying their conclusions about the cause of cancer or
about their treatment" (Green, 1998). This statement has no bearing on
the effectiveness of the program. This program is not designed to diagnose
but rather to treat the cancer once it has been diagnosed. Patients that enter
the program have been diagnosed by conventional physicians, who, in many cases,
have told the patient that the cancer is untreatable by conventional approaches.
Dr. Kelley does not advocate dismissing medical doctors, but rather encourages
the patients to maintain regular visits, to trust and to work with their medical
doctors Additionally, Gonzalez is presently conducting a scientific study to
verify his conclusions.
Green (1998) states in rebuttal to the Kelley program that, different cancers
do not have identical causes, growth characteristics or response to treatment.
Conventional medicine has yet to firmly establish any cause for cancer. According
to conventional medicine, they do not know nor fully understand the cause of
cancer therefore they cannot prove that different cancers do not have identical
cause and growth characteristics. What they do understand of cancer still remains
consistent with Beard's theory of cancer. Robbin's pathology textbook
states that in most neoplasms (any abnormal growth of new tissue) the parenchymal
cells bear a close resemblance to each other, as though they were all derived
from a single cell (Cotran et al, 1999). This statement regarding cancer actually
helps to confirm Beard's theory. The statement that different cancers
have different response to treatment is obviously true and cannot be argued
as every person is an individual and responds uniquely in different situations
to varying stimuli.
Critics have mentioned that the Kelley program has no controlled studies. First,
it must be mentioned that there are no controlled studies for human chemotherapy,
radiation or surgery for cancer patients, as this is seen as unethical. Therefore
the ‘standard of care' used in allopathic medicine has yet to be
scientifically proven. The study that Gonzalez is presently conducting on patients
with pancreatic carcinoma does have a control group that receives conventional
medicine treatment, which is ‘state-of-the-art' chemotherapy. Having
this control group is good for science but not necessarily good for human life.
Chemotherapy for pancreatic carcinoma has been shown to have no convincing
improvement in median survival (Ahlgren, 1996). Therefore, being in the control
group is equivalent to a death sentence. This is about human life and randomly
assigning a person to this type of control group for the sake of "good
science" is completely unethical and devalues human life.
The author believes that one can prove that this treatment is effective, meaning
it has a strong claim for a causal relationship between the Kelly treatment
and the various cure indicators, without having a control group, and the study
can still be considered "good science." For example, the Kelley
method can be studied using a quasi-experimental design, which does not involve
random assignment to control groups, but does attempt to rule out threats to
internal validity by collecting data that can be used to examine these threats
(Shavelson, 1996). The time series design would probably be the most effective
design, whereby multiple observations are taken before and after a treatment
is administered. The multiple pre-treatment observations establish a control-group
baseline and the multiple post-treatment observations establish a consistent
change in response. The dependent variables that can be physically measured
include tumour size and serum cancer markers.
The standard of care in allopathic medicine to treat cancer is chemotherapy,
radiation and surgery. Chemotherapy and radiation act to kill all fast growing
cells. It may degenerate the tumour cells but it also damages the healthy cells,
like cells responsible for hair growth, the cells lining the digestive tract,
skin cells and most importantly, immune cells. Damaging the healthy cells makes
it more difficult for the body to heal itself. Allopathic medicine fails to
understand the enormous capacity that the body has to heal itself and instead
are working against our natural healing powers, when it would be more worthwhile
to work with the body. In many cases the conventional approach to treating
cancer is causing the patient more harm than good.
Chemotherapy does not treat
the cause of the problem. Removing a tumour by methods such as chemotherapy,
radiation or surgery, does not remove cancer per se because cancer is a process
and therefore you need to stop the process. Additionally, allopathic medicine
tends to treat the disease, not the person, when it should be the other way
around. The allopathic method to treat cancer requires putting your life in
the hands of a doctor whereby the patient plays a passive role. The author
believes many of these factors contribute to the ill-success of the allopathic
approach to cancer treatment.
There exists a major problem in the scientific model with regards to health.
Human healing never happens in isolation. Therefore the scientific model is
flawed and invalid when it comes to healing methods. Health cannot be defined
by only one variable as it exists at 3 different dimensions; mind, body and
spirit. Healing cannot be isolated, whereby all other variables are kept constant,
as healing and achieving "health" is a multifactoral process. The
scientific model also bases all conclusions on what they are able to see and
what they can measure in the physical body. But in terms of health, people
are more than physical beings. Nevertheless, the author does strongly encourage
studies be done that test the Kelley program by using all the physical measures
such as tumour size, serum cancer markers, side effects, survival time and
quality of life as its measurements of effectiveness.
The Kelley method for cancer treatment seems to have been completely overlooked
by conventional medicine and deserves further investigation, as there is substantial
research that does support its theory.
Conclusion
Many studies have shown that each component of the Kelley program shows some
degree of effectiveness at treating cancer. There are also studies that support
Beard's original theory of cancer. Therefore, further investigation
of the Kelley program is definitely necessary to evaluate its effectiveness,
which includes all 4 components, in order to properly prove or disprove this
cancer treatment.
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