Johanna Budwig at work in her lab.
   


    
Of the many cancer practitioners that have practiced their trade for a cure throughout history, I can think of only three that seemed to have documented uncanny success in a clinical working practice! I don't know about you, but I consider theory all well and good, published scientific articles interesting, double-blind studies of some value despite often obvious bias, but when it comes to the real proof, real world results cannot be beat in a clinical setting on real patients. The first was Dr. Johanna Budwig (1908-2003) whose protocol has been documented at a 90+% success rate. Her premise was that with the right type of essential fatty acid supplementation plus supportive diet, cancer can be cured. The other two, William Donald Kelley DDS (1925-2005)  with a 90+% rate and Dr. Nicholas Gonzalez, MD (1947-2015) both championed the trophoblastic theory of cancer involving pancreatic enzyme supplementation and both took detailed records of their cancer patients. I want to suggest that these three with two differing theories can be connected with common threads and should be considered as one paradigm. On this page, I would like to investigate the Trophoblastic theory and how it may be implemented into the Budwig Protocol to formulate a hybrid even more valuable in treating cancer. 



The Budwig Protocol

     I have done three webpages on this site discussing in depth Johanna Budwig's theory, and I would suggest you go to those pages for more detail. I will summarize on this page, her basic principles.  First, her theory is based on Otto Warburg's theory on the cause of cancer. His hypothesis:  "Cancer, above all other diseases, has countless secondary causes. But, even for cancer, there is only one prime cause. Summarized in a few words, the prime cause of cancer is the replacement of the respiration of oxygen in normal body cells by a fermentation of sugar."  In short, he is saying that cancer is a cellular mitochondrial respiration dysfunction. Dr. Budwig agreed and formulated a protocol of supplementing cancer cells with flaxseed oil incorporated in cottage cheese for more efficient bio-absorption of the Omega-6 group, Linoleic acid (LA) and of the Omega-3 group α-Linolenic acid (ALA). She also included in her treatment, a supporting diet designed to cut off what she considered to be, toxic respiratory poisons found in the abundant factory processed fats common to the modern diet. According to her, flaxseed oil supplementation would turn around the cancerous cell that relied on fermentation (glycolysis) respiration back to the normal healthy aerobic form of respiration. 

I might also add, Dr. Budwig seemed to think that any cell in the body could become cancerous as did Otto Warburg, if its mitochondria were allowed to slip into the more primitive anaerobic, fermentation mode. Budwig felt hydrogenated factory processed fats was the preeminent likely culprit for such cancers. I, personally, would modify her oil supplementation by adding a high linoleic acid oil as my prime oil, using cold-pressed, unrefined sunflower oil as an example. Perhaps, times were different back in the mid-20th century and Dr. Budwig was able to achieve excellent results with a low linoleic acid oil like Flax oil, but now, with later scientific studies on the cellular respiration mechanics of cells, it is obvious that one needs to supplement with linoleic acid  (Omega-6) more than linolenic acid (omega-3) to revive the cardiolipin layer found in mitochondria. I go into this debate in more detail at my Budwig science webpage.



The Trophoblastic Model of Cancer

     To avoid any misconceptions, the trophoblastic model of curing cancer is for all cancers not just pancreatic cancer.  Don't let the label "pancreatic enzyme therapy" mislead you!  Volumes have been written on this theory for almost a hundred years, yet Europe and India seem to be the only ones where it has become accepted therapy to some degree.  Here in the USA, this theory has always faced tough blow-back from the medical establishment with all of this country's past medical practitioners who dared experiment with pancreatic enzymes being unanimously censored. It is still an obscure theory for the masses with the exception of those in the alternative medical fields  I will try to simplify, writing a pertinent summary of its history and bioenergetics while at the same time trying to keep it simple for the more science-challenged reader. Forgive me if I occasionally over-step these boundaries.

     The founder of the Trophoblastic Theory was the British embryologist and histologist, Dr. John Beard  in 1902.  As an embryologist, he found the physiological and bio-chemical characteristics of the embryo's placenta (trophoblast) to be intriguingly similar to how cancer cells formed and metastasized. He felt that this similarity of the embryonic cells to cancer cells could be of value in understanding and treating cancer.  He theorized that the body reuses the same embryonic bioenergetic mechanisms with cancer as it uses with fetal implantation.   In a nutshell, Dr. Beard defined cancer as a malignancy developing only from what he labeled as "vagrant germ cells" (adult stem cells) sprinkled throughout the body's tissues, whose trophoblast is stimulated into wild cellular proliferation by a lack of adequate volumes of pancreatic enzymes. This would also include not only adult stem cells but the germ cells that ultimately locates in the embryo testes or ovaries--all possible sites for cancer. Adult stem cells can replicate into a daughter stem cell as well as differentiated cells designed to replace defective tissue cells in a never ending progress of natural regeneration. However, in the case of cancer, a stem cell can get the wrong signals to become cancerous. In contrast, differentiated cells are set and can not proliferate as would cancer cells.

     Let's do a little cell biology before we go much further. The cellular terms,  differentiated versus undifferentiated are important. The undiffereniated cell is a primitive cell that can form into any specialized tissue as needed.  We commonly call these, stem cells. Stem cells can either be embryonic or adult stem cells with both having the capability to replicate endlessly.  Differentiated cells are cells that cannot replicate and have histologically become specialized into bone, skin, ligament, heart or any other specialized tissue cell. In mammals, only certain types of cells have the capability to replicate:

(1)  germ cells  (found in the testes and ovaries)
(2)  fibroblasts  (vital in wound healing, found in connective tissue)
(3)  stem cells

It was Dr. Beard's theory that cancer can only be generated from what he called, vagrant germ cells or what we would label today as adult stem cells. His vagrant germ cells initially matured outside of the embryo in the yolk sac, but in their natural journey during embryo development from this outside yolk sac to the final destination of the embryo gonads (sex organs), many of these cells became separated and ended up being sprinkled into permanent homes within the various developing tissues other than the gonads (future sites of possible cancer). Hence, these scattered replicating, undifferentiated cells are only found in limited numbers in various tissues plus in the testes and ovaries.  Cancer cannot be generated from differentiated cells commonly found in all areas of the body! This goes against the long held belief among many that any cell can produce cancer in the body, if presented with the right toxic environment. Dr. Beard said, no! Once the cell has been differentiated as most of the cells in our body are, it could not replicate or give rise to a malignancy--only germ or stem cells have that capability. Any given tumor will mostly consist of set differentiated cells with only a sprinkling of cancer stem cells throughout which can actually replicate that cancer. One can remove most of the tumor and its array of cells, but unless the surgeon can excise all of the cancer stem cells found in and around the tumor, chances are, that tumor will regenerate!  Dr. Beard did some lab work in 1905 which seemed to confirm his theory. He injected two Jensen tumor rats with injectable enzymes resulting in both of their tumors regressing with necrosis. The control mice receiving no injections, continued to have their tumors increase in growth without change. After publication of these results, as to be expected, a number of physicians started experimenting with pancreatic enzymes the following year with some excellent successes on real live cancer patients but, in all fairness, there were probably numerous failures as well. Misunderstood failures can be very powerful when used by those with bias and an axe to grind.  I suspect this was why Beard's work never really was able to gain a foothold in the USA. I will discuss later on this page why these failures probably happened and why we need to learn from the failures and not simply condemn the entire paradigm.

     By the time Dr. Beard died in 1924, his trophoblastic theory was pretty much relegated to the dustbin as of little import by the medical establishment. It was only by pure happenstance that his theory was resurrected with new life and proponents starting in the 1960s--thanks to social media of that time, mass published health books! It really all started with a Texas dentist, Dr. William Kelley having self-diagnosed himself with pancreatic cancer in only his 30s. Since he refused to have biopsies performed, it is hard to say if this diagnosis was in truth pancreatic cancer. Certainly, he thought so from symptoms and visible external tumor signs.  Kelley suggests that his doctors agreed as well:

 "I  had undergone many other tests and diagnostic procedures including  x-rays,  when the internist suggested biopsies of my pancreas, liver, and intestines. My wife was privately told not only that I had tumors in all 3 organs (the  pancreas,  liver and intestines),  but also that in the doctor's opinion, I had no more than 18 months to live. Meanwhile, the chief surgeon in our locale  had  ruled  out  full-scale  surgery  because  he thought I was in such bad shape that I wouldn't make it off the operating table alive. My wife had been told to take me home and get our affairs in order as promptly as  possible for it wouldn't be long before I'd passed away."

For the purists and critics, this would be a major flaw in Kelley's work using himself as proof. On a personal note, I would be like him in wanting to avoid biopsies. Biopsies have many acknowledged downsides,  the least of which could be an added spread of the metastasis. Even if he didn't have cancer, his successes with his 33,000 patients are impressive enough!  Dr. Kelley first became ill in 1963 which eventually led to his diagnosis in 1967 of late stage pancreatic/liver cancer with only a few months to live.  He was always a frustrated want-a-be physician, self-reliant, inquisitive personality with a biochemistry and dental degree.  He found this death sentence a personal challenge, particularly since the medical establishment gave him little hope. As is often common, pancreatic cancer causes very poor digestion in its victims. He was no different and found his normal family dining fare impossible to eat without distress. He decided his first DIY strategy must be a diet change. This new diet would avoid processed foods for a raw vegetarian one plus supplements along with detoxification procedures. Nevertheless, he still found that his digestion was much impaired.  Accordingly,  he decided to experiment with larger oral dosages of pancreatic enzymes to help overcome this vexing digestive problem. Pancreatic enzymes were commonly used as digestive aids back then, sold over-the-counter. Finally, the larger dosages did indeed seem to help his digestive disturbances and, even more surprising, after a few months on this regime, his pancreatic tumors appeared to be regressing  just from simple external observation! This really piqued his curiosity of what was going on! He started scouring the medical literature on any relationship between pancreatic enzymes and anti-cancer properties. This research eventually brought him to Dr. Beard's earlier work of which he had not until then known existed. Now it all seemed to make sense to him!

     Dr. Kelley became famous as a pancreatic cancer patient who cured himself and people started flocking to his Texas dental office asking for cancer help. Initially, he gave his advice away freely, but increasing numbers of advice seekers started to interfere with his professional time devoted to making a living with dentistry. He decided to write a book for them, One Answer to Cancer (1969) as a way to disseminate his message without disrupting his dental practice.  His published book brought notoriety both good and bad. The bad, he became a target for mainstream medicine, labeled a quack, practicing medicine without a license.  The "good" part, if you could call it that, caused him to leave dentistry to devote his full time in consultation of his protocol to the many cancer patients who now knew he might have an answer to their woes. In the end, he saw approximately 33,000 documented cancer cases and is said to have achieved around a 93% success rate for those that followed his protocol. Later in his life, he became frustrated, embittered and seemed to fall prey to a conspiratorial type personality. Dr. Kelley is not without flaws, who of us are not? One must appreciate his discovered grains of truth and separate it from the chaff in his life. Though Nicholas Gonzalez had his ups-and-downs with Dr. Kelley, he seems to have analyzed the Kelley protocol the most fairly in his many books.

    Nicholas J. Gonzalez M.D. was the next to come into the modern era Trophoblastic fold by pure happenstance as well. As a second year Cornell medical student, a journalist friend wanted to write a book on the controversial dentist, Dr. William Kelley,  who was making headlines 1981. She had no medical expertise and needed Gonzalez to do a preliminary interview with Dr. Kelley for a creditable opinion that he just wasn't a kook! As Dr. Gonzalez remembers, she needed to know if: ". . .he  was  brilliant or crazy,  brilliant and crazy,  or some combination thereof?" He finally agreed to help her out and: "Within 5 minutes of meeting Kelley, I knew that he was the  smartest  man  I'd  probably  met  next  to  Dr. Good (his brilliant medical school mentor)!"  Gonzalez was impressed how Kelley wasn't in it for the fame or money but simply wanted his theories & protocol appreciated as a valuable cancer treatment. What's more, he seemed to have a large number of well documented cases and invited Gonzalez to Texas to analyze his work. Gonzalez with the blessing of his med school advisor, Robert A. Good, MD, PhD, president of Sloan-Kettering Institute, flew down immediately to Kelley's office to inspect his files and interview patients.  Kelley had great respect for Dr. Good and felt Good and Gonzalez would give his work a fair analysis. Gonzalez was impressed with what he saw to say the least and came back to report to Dr. Good his findings. Dr. Good was equally impressed seeing file copies and suggested to his student, he should do a research study.  The Kelley study eventually involved 50 case reports of 26 different types of cancer including the medical records proving they had  cancer diagnosed at major institutions like Stanford, Sloan-kettering or the Mayo Clinic.  This study also concentrated on Kelley's pancreatic cancer cases which showed a significant prolongation of life for this very deadly cancer including patients with stage IV, biopsy-proven, liver metastases from pancreatic cancer who were alive 5 to 10 years later. Fast forward to 1987, Dr. Gonzalez and his ex-wife, Linda Isaacs MD, decided to open up a New York clinic where he would specialize in his version of the Kelley protocol, specializing in the deadly pancreatic cancer. Doesn't this make sense? If you were a young med student and came across a technique that seemed to blow all other current methodologies out of the water, wouldn't you do the same? Why he has been commonly labeled a quack by the mainstream medicine, as one who suckers the public is simply disingenuous and an easy ploy used by his enemies. Follow his career and you will see someone that only wanted to make medicine better. If you want to gain insight into legitimate alternative medicine and there are a lot of charlatans out there, just study the person's background and follow the money! Both Kelley and Gonzalez passes this acid test.

Before moving on, I want to suggest perhaps some proof that this theory may be valid, may be seen in the mammalian heart. Primary cardiac cancers are exceedingly rare in life. Isn't that very curious? Also, consider that though there is debate and controversy on the regenerating qualities of heart muscle, generally it is believed that the heart does not contain stem cells and thus, cannot regenerate muscle tissue. So, perhaps, if the Trophoblastic theory of cancer is valid, maybe this is one reason why cardiac cancers are so rare? As one 2015 study writes:


"
For decades the common dogma was that the adult heart is incapable of regenerating lost myocardium after injury. Achieving cardiac regeneration or stimulating endogenous repair mechanisms to restore cardiac function after injury has been a goal of countless investigators. The longstanding belief that the adult heart has lost its capacity for self-renewal was a result of two simple observations. First, after myocardial infarction, there does not appear to be significant self-healing; instead, the primary repair mechanism is scar formation. Second, primary cardiac cancers are exceedingly rare, and cardiac rhabdomyosarcomas arising from cardiac myocytes are even more so."







The Trophoblast vs Cancer

What is a trophoblast and what is its connection to cancer? It is the outer layer of cells in the newly formed fertilized egg that will become the placenta of the fetus.   The trophoblast layer is vital in the initial adhesion of the fertilized egg to the uterine wall and implantation. The illustration to the right shows the  trophoblast cell layer during implantation and invasion into the uterine wall.  The similarities of cancer versus the embryo's trophoblast:

1)   The cells of both the trophoblast and cancer are physiological similar in that they are both primitive undifferentiated germ cells.
Cancer cells eventually differ from the trophoblast cells in that they never mature, continually proliferating while the trophoblast will differentiate into necessary specialized tissues of various types over time with cell invasion stopping.

2)   Both cancer and trophoblastic cells can easily and aggressively invade into outside tissues using the same gene expressions, the same secretions.
  There are far too many similarities found in the cellular behavior of the infiltrating trophoblastic placental cells when compared to metastatic cancer cells for it to be just a coincidence. One of the defining actions of cancer is its ability to infiltrate into and pass the basement membranes. A benign tumor cannot do this. It is trapped by the basement membrane. A cancer cell, like its trophoblastic cousin can penetrate this tough base membrane signaling the beginning of a metastatic cascade.  After punching through this barrier into the adjoining connective tissue, the cancer cells migration is helped along by secretions from the normally protective fibroblasts and immune cells of the host. Dr. Gonzalez writes: "At all levels, the cooperation between invading tumor cells and host  resembles very closely what happens as the trophoblast makes its way through the uterine lining and underlying tissues." It is never a one-sided affair! Everything in the host's body seem to willingly cooperate with either the trophoblast or cancer cells for the final solution, be it a fetus or a tumor.


3)   Both cancer cells and trophoblastic cells are capable of high cellular proliferation in an oxygen-poor (hypoxic <2% oxygen) environment via glycolysis.


4)   Both cancer and trophoblast cells can migrate.  Normal cell matrixes are "tight" by nature offering a natural boundary  to keeping it safe and free from invasion. However, cancer and trophoblast cells lack such tight bonding characteristics. They can break loose and migrate. The normal close, tight connections between cells within the body's many structures will discourage full blown cancers if left intact. Tumor cells, like trophoblast cells secrete enzymes that will break cellular bonds.


5)   Both can stimulate blood vessel formation for self-nutrition
. Like a developing embryo, a cancer cell cannot make it on its own but needs a supporting nutrient source from the host.  A tumor cannot grow beyond one cubic milliliter without being nourished by the host's blood system.


6)   Both have very similar biochemical, signaling, enzymatic pathways
.  For instance, every cancer studied, secretes the hormone hCG (human chorionic gonadrotropin).  In early embryo development, the trophoblast begins secreting hCG as well. hCG was considered a unique trophoblastic hormone until only recently, thought to not be found in any other type of tissue. Now we know cancer secretes it, too! This is only the tip of the iceberg to similarities of the two.


7)   Trophoblast and cancer cells both escape the defensive processes of the immune system
. The immune system sees a fetus as well as a tumor as part of its being and will generally not attack it as it would some other toxic invading element. In fact, the immune cells along with the healthy stroma cells (connective tissue, blood vessels, nerves, ducts, etc) are vital in aiding cancer to invade and prosper by secreting supportive enzymes to pave that way!


As Dr. Gonzalez writes:
"In his writings, Dr. Beard actually went quite a bit further than mere similarity between the two tissue lines, suggesting that the trophoblast not only resembled malignant tissue in its appearance and activity, but was the very cell line from which all cancer developed--and the only cell from which malignancy could form."







The Pancreas and Cancer

     The pancreas is often treated as an after-thought in medical anatomy. Not very romantic in any sense of the word. It is primarily known as a digestive gland located right next to the stomach with ducts draining into the small intestine's duodenum. It secretes bicarbonates to decrease acidity, plus enzymes which will break down the carbohydrates (amylase),  protein (trypsin, chymotrypsin) and fats (lipase) coming out of the stomach for further digestion. The pancreas is also important as an endocrine gland that secretes insulin, glucagon, somatostatin, and pancreatic polypeptide into the blood stream. The main pathologies of the pancreas:

1) Diabetes mellitus (DM) . . . . . . . . .  is the pancreas failing to secrete enough insulin or the body cells not responding properly to the insulin secreted.  Type 1 (juvenile diabetes) is pancreas's failure to produce enough insulin while Type 2 starts out with cells failing to respond properly to insulin, but as the disease evolves, it can develop into impaired insulin secretion as well. Both type 1 and 2 has been linked to increased cases of cancer. A 2013 monograph in Gastrology writes: "Patients with well-established, longstanding diabetes have an approximate 2-fold increase in risk of pancreatic cancer. The increase appears to apply to patients with adult-onset diabetes and probably those with early-onset or type-I diabetes."

2) Pancreatitis . . . . . . is simply an inflammation of the pancreas. It can cause amylase and lipase levels to be increased up to 3 times normal (Hyperlipasemia). Interestingly, Jeffrey Dach MD writes:
"There is no coexistence of Cancer with circulating enzymes of Pancreatitis. One last point I am compelled to mention.  During my 30 year career as a radiologist, much of my time was spent reading images of metastatic cancer on CAT scans.  One of the things I noticed was that I never witnessed the presence of metastatic cancer in patients who had pancreatic enzymes circulating freely in the bloodstream from acute or chronic diffuse Pancreatitis.  Excluded of course was focal Pancreatitis caused by an obstructed pancreatic duct due to a small pancreatic cancer.  Thus I had independently confirmed the major tenet of John Beard and Ernst Krebs many years before I even heard of the trophoblastic theory of cancer."

3) Cancer . . . . . . . of the pancreas is one of the most deadly of all cancers. Wouldn't you consider this very logical if the Trophoblastic Theory was indeed true? What could be more logically deadly than cancer of a gland that was behind the cause of cancer? On a some what related note: Dr. Jeffrey Dach MD had this to say:  "Cancer of small bowel is relatively rare.  Another observation most experienced radiologists and surgeons will make is the relative rarity of neoplasm involving the small bowel compared to the relative common appearance (50 times more common)  of neoplasm (cancer) in the colon and the stomach.  Ernst Krebs makes this same observation in his landmark 1950 paper on the unified trophoblast theory of cancer, and Krebs suggests that pancreatic enzymes released into the duodenum at the duct of Wirsung and Santorinin are responsible for this 50 times reduction in small bowel cancer."

4) Exocrine pancreatic insufficiency (EPI) . . . . . . is the lack of adequate digestive enzymes in an individual resulting in poor digestion. A common problem in dogs. One would think that if the trophoblastic theory is correct, EPI would favor high incidents of cancer. At the present, there are no specific studies linking EPI patients to all types of cancer.  I do find it interesting that most pancreatic cancers result in EPI, but does one ever really look for EPI before cancer? Which came first in reality?



     Of the many types of tissue found in mammals, only the placenta has the characteristic of being able to aggressively invade other tissues. The placenta can be regarded as a physiological counterpart to a highly invasive malignant tumor.  The comparison ends here as the placenta knows precisely when to stop growing while cancer cells generally do not.  The placenta transforms from a primitive, undifferentiated, invading, migratory blood sucking tissue to the stable mature placenta only when the embryonic pancreas begins functioning at approximately 8 weeks (human's) in the fetus' life.

     Dr. Beard observed via microscope in 1889 that at a specific predetermined time, the trophoblast started becoming contained as the embryo matured. He could not figure out why!  After many hours of detailed microscope work, he started to put together the theory that the time when the trophoblast matured and achieved containment was when the fetus developed its embryonic pancreas. The digestive enzymes of the pancreas was the triggering signal!  During 1894-1895, "He was the first scientist to report that the embryonic pancreas in a number of mammalian species begin synthesizing digestive enzymes quite early in development, 7-8 weeks in humans he claimed just at the time the trophoblast changed from a proliferating and invasive tissue into the life sustaining and well-behaved placenta."  He reasoned that these circulating digestive enzymes must have a purpose in the fetus other than digesting food as the fetus did not need nor have an active digestive system at this time. These enzymes must be crucial for the trophoblast maturation! As Dr. Gonzalez writes: ". . . in a January 20, 1905 lecture, he delivered in Liverpool, he first presented his thesis that since pancreatic enzymes such as trypsin, ultimately suppress trophoblastic growth in the uterus, and since cancer was trophoblastic in origin, trypsin must represent the body's main defense against cancer and would be useful as a cancer treatment." Modern scientific work seems to confirm all of this and more. A 1989 monograph, the researchers found that fetal samples contained higher levels of trypsin than did the maternal blood, but lower levels of amylase and lipase than the mother. A 1995 study found that not only did the pancreas produce amylase, trypsinogen and lipase, but the liver did too. This would suggest that the presence of these embryonic enzyme levels are so important for development, that mother nature not only required the pancreas to secrete them, but the liver as well.
future NOTES:

A formulation of pancreatic pro-enzymes provides potent anti-tumour efficacy: a pilot study focused on pancreatic and ovarian cancer.
Perán M1,2, López-Ruiz E3,4, García MÁ4,5,6, Nadaraia-Hoke S7, Brandt R7, Marchal JA4,6,8, Kenyon J9.
Author information
Abstract

Proteolytic enzymes have shown efficacy in cancer therapy. We present a combination of the two pro-enzymes Trypsinogen and Chymotrypsinogen A with potent in vitro and in vivo anti-tumour efficacy. A synergetic anti-tumour effect for Trypsinogen and Chymotrypsinogen A was determined at a ratio 1:6 (named PRP) using 24 human cancer cell lines. The antiangiogenic effect of PRP was analysed by matrigel-based tube formation and by fibrous capsule formation assays. Furthermore, cell invasion and wound healing assays together with qRT-PCR determination of epithelial-to-mesenchymal transition (EMT) markers were performed on human cancer cells treated with PRP. Additionally, in vivo pharmacokinetic studies were implemented and the PRP's anti-tumour efficacy was explored against orthotopic pancreatic and ovarian cancer tumours. PRP formulation was proven to inhibit in vitro angiogenesis, tumour growth, cancer cell migration and invasiveness; and to be an effective and well tolerated in vivo anti-tumour treatment. Finally, the clinical efficacy of a suppository formulation containing both pancreatic pro-enzymes in the context of a UK Pharmaceuticals Special Scheme was evaluated in advanced cancer patients. Consequently, PRP could have relevant oncological clinical applications for the treatment of advanced or metastatic pancreatic adenocarcinoma and advanced epithelial ovarian cancer.
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During more than 100 years of commercialization of pharmaceutical products containing pancreatin, no case has been reported where patients have been actually affected by pancreatin contaminated by any virus. However, companies producing phar- maceutical products derived from biological tissues and/or body fluids experience increasing pressure from the regulatory bodies to increase the level of safety of their products by reducing all kinds of contaminants
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... Porcine pancreatin has been reported as a source of hospital acquired salmonellosis, and contamination of a powdered preparation of pancreatin with Salmonella spp. resulted in cases of infection (Gleencross, 1972; Rowe and Hall, 1975); to our knowledge , however, no virus contamination events involving pancreatin have been reported to date.



Dr. Kelley: "Our pancreatin supplements are about $2500 a month for the first 6-9 months and then it is drastically reduced. You can go to a health food store and get the strongest pancreatin you can buy and it is about 1/5th the strength of the pancreatin I make myself.  The best prescription pancreatin is about 1/4 the strength of the pancreatin I make that will work on about 52% of the people. So if you want to chance it, and if your own pancreas is producing some pancreatin, take a pancreatin at the health food store. Ours is a strong, strong pancreatin. There is nothing on the market that is as strong except the formula SA plus it is a little stronger."

Frank LeForest Morse, MD -- "Eschewing   commercial   enzyme   products   (which Beard  also  believed  were  unreliable),  Morse  made  his own fresh extracts from pancreases that he obtained from local  slaughterhouses-a  messy  but  potentially  effective process. After a decade of quiet clinical work, on March 6,  1934,  he  presented  his  results  at  a  meeting  of  the  St Louis Medical Society. Morse tried to tamp down expectations by reporting that there was no rapid resolution in cases of advanced cancer, much less cures, but that after 4 or 5 injections many patients began to feel better, had an  increase  in  strength,  weight,  and  hemoglobin  scores. He  told  his  St  Louis  colleagues  that  the  patients  "really look  better,  but  it  is  usually  3  or  4  months  before  any changes can be noticed in the size of the growth."

Introduction Studies have revealed that emodin is a potent agent in the management of clinical and experimental acute pancreatitis, but the molecular mechanisms by which emodin produces its biologic effects, especially on pancreatic regeneration after acute pancreatitis, remain unknown. Numerous experimental and clinical studies have shown that somatostatin analogs have favorable effects on acute pancreatitis, but their role in the management of acute pancreatitis remains controversial.

Emodin (6-methyl-1,3,8-trihydroxyanthraquinone) is a chemical compound that can be isolated from rhubarb, buckthorn, and Japanese knotweed (Fallopia japonica syn. Polygonum cuspidatum).[2] It is also produced by many species of fungi, including members of the genera Aspergillus, Pyrenochaeta, and Pestalotiopsis, inter alia.

A search on phytochemicals and pancreas:

https://journals.lww.com/pancreasjournal/pages/results.aspx?txtkeywords=phytochemicals

Pancreatic enzyme supplements are normally administered orally with meals. As these supplements pass through the low pH environment of the stomach, their enzyme activity diminishes rapidly. As a result, large quantities of enzyme concentrate (sometimes as many as 15 capsules or tablets per meal) have been required to ensure that sufficient active enzyme is present in the proximal intestine to relieve pancreatic insufficiency.

Whether or not a given pancreatic enzyme supplement is enterically-coated, the bioavailability of such supplements varies widely, due to differentials in acidification of the intestine among patients.  batch-to-batch variation in enzyme activity, susceptibility to loss of activity over time by exposure to sunlight, heat or humidity and a poorly defined profile of adverse reactions, 

Gonzalez:    Patients normally take the pills for fifteen days, then flush their systems for five days. This cycle is repeated continually. "People ask me if they need to stay on the program after they feel better,'' Gonzalez told me, "and I tell them only if they want to stay alive." The list of supplements that Gonzalez hands out to most patients with solid tumors runs to four single-spaced pages. It includes, in part, sixty freeze-dried, porcine-pancreatic enzyme pills (swallowed in six batches, all of which must be taken with water, and none of which may be taken with food or within an hour of a meal). During breakfast and dinner, each patient must swallow capsules of adrenal medulla, amino acids, bone marrow, selenium 50, thyroid, Vitamin A 10,000, and Vitamin E succinate.



Pancreatic Enzyme Therapy

    
     I want to say up front that it is the nature and expense of pancreatic enzymes that really makes this therapy a difficult one to do! I want to also speculate that it is exactly this difficulty in the nature of this beast both in the processing and storage of these medicinal enzymes which is the number one reason why so many varied results have occurred in over 100 years of therapeutic history from physician-to-physician and researcher-to-researcher. If a physician or researcher is working unknowingly with inert enzymes, misconceptions are bound to occur, terrible failures versus brilliant successes!

     I first became familiar with the Trophoblastic Theory maybe 5 or more years ago, and I was immediately turned-off by how expensive pancreatic enzyme tablets were on the open market! At this writing, a 720 count bottle of 425mg Pancreas natural glandular (Pork) tablets goes for any where from $115 to over $130 per bottle. Outrageous, if one considers the huge number of tablets that they say must be taken per day. This is economically undoable for most people.  Dr. Kelley wrote a number of years ago that it takes about $2500 worth of tablets and other supplements per month for the first 6-9 months of his treatment. If that is true, we are looking at approximately US$15,000 to over $22,000 just for the tablets that insurance companies will never pick up. Remember, this is an old years-long estimate from Dr. Kelley! No doubt, much higher now. Who can possibly afford that? Dr. Gonzalez writes:
"Depending  on  the  situation,  how  aggressive the cancer is, and how much they have, usually anywhere from 80 to 110 capsules a day. A capsule is 425 mg of pancrease, so it's a pretty hefty amount. You're talking 35, 40, 45 grams a day, spread through the day in six or seven doses. For anticancer effect,  they  have  to  be  taken  away  from  meals;  otherwise they'll spend time digesting food. You want to take them on an empty stomach so they absorb quicker.  We use a pork-based pancreas because it's more effective in humans but some people are allergic to pork. We have a lamb enzyme that's a second tier approach and it's milder. For people who have a history of ulcer disease,  we'll  suggest the lamb because  it's a little milder. It still works, it's just not as effective  as  the  pork pancreas."  Presuming you take the low end of that estimate of 80 tablets a day, a 720 count bottle would last you only 9 days at over $100 a bottle ($300+ a month). At the high dose of 110 capsules, a 720 count bottle would last a bit over 6 days ($500+ a month). On this page, I will suggest to you a better and much cheaper way that you can get your pancreatic enzymes, canceling out the exorbitant profits of the middle-men.

     I come from the herbal world which makes me quite familiar with how biologic medicinal substances can so easily deteriorate in processing and storage.  It also makes me familiar with how commercial processing of these natural substances may not be generally good for final potency in the purchased retail product simply because the companies have to produce a product that can be easily shipped, used, and stored which is not necessary for the home DIY processor and on top of all this, approved by the FDA. With herbs, I much prefer harvesting my own fresh plants from the fields on my farm or general area in order to obtain the most potent and cheapest medicinal without having to resort to buying a dried herb from the commercial companies where one never knows how that herb was harvested, processed and stored. Pancreatic enzymes would be no different! You are much better off going to the local slaughter house or butcher and buying freshly harvested pancreas that you know has been immediately put on ice until you can minimally process it yourself for your own use! The key word here is minimally processed!  On this page, I will show how raw pancrease that is minimally processed is better and cheaper than any tablet!

     You know in these current times, patients never seem to achieve the renowned success results that were obtained by the original medical systems that were overseen by the masters. Both the Budwig and Pancreatic Enzyme therapies are no different. Many modern adherents to these two systems seem to have problems with successful cures, unlike those original documented patients that brought so much fame to these systems with 90%+ success rates. I truly believe one of the key failure points of both protocols is simply that the medicinal compounds being used are not potent as they were originally used! They are uselessly inert for various reasons unlike in the past! For instance, rancid flax seed oil is rampant on the shelves and warehouses of the USA. I cannot begin to tell you how many clients I have pointed to the Budwig protocol that buy flax seed oil for the first time ending up detesting its taste! Fresh flax seed oil should always have a pleasant, nutty, grassy taste. If there is any type of unpleasant tang, that oil is going rancid and is worse than no treatment at all. The same would be true of pancreatic enzymes, though they won't go rancid like flax seed oil, nor have an off taste.  Enzymes can easily suffer degradation in harvesting, processing, and storage conditions. Temperature, pH, enzyme concentration, substrate concentration, and the presence of coenzymes, inhibitors or activators, all can affect the final potency of pancreatic enzymes with the average patient only knowing that he or she is no better for taking them. The Levin method patent writes:
"Certain tissues should be treated immediately after the animal is killed, or should be deep frozen as quickly as possible in order to prevent loss of activity.  The enzymes are sensitive to heat and it has been found that they are generally destroyed at temperatures above 140°F, if the temperature is held at this point for any substantial period of time. When treating pancreas, it has been found that the dried, defatted substance remaining after treatment at 158°F,  exhibited no activity for trypsin, lipase or amylase. When treated below 140°F,  the material had enzymatic activity, although if 140°F is exceeded,  the enzymatic activity is rapidly degraded, for practical purposes approximately 122-131°F should not be exceeded, and it is preferred that the operation be carried out at about 113°F.  "It should also be noted that even at room temperatures, small amounts of moisture can convert the raw pancreas precursors into active enzymes. A raw pancreas in the slaughterhouse waiting to be put on ice can easily degrade."  warns Dr. Gonzalez.  Use dry ice to avoid moisture as well! The more personal control you can exert on harvesting and processing your medicinal compound of choice, the better. I am a rabid do-it-yourself fan.

     In the culinary world, the pancreas as a food product is called sweetbread which can be grilled, braised, breaded and seared or fried. In the pharmaceutical field, the label, pancreatin, is used to denote the medicinal pancreas extract which will contain an array of the digestive precursors of the pancreas (amylase, lipase and protease) along with the activated enzymes (trypsin, chymotrypsin) plus many other lesser known/unknown enzymes, minerals, coenzymes, etc. in one product.  Note that the raw pancreas only contains inactive precursors to trypsin and chymotrypsin in the form of trypsinogen and chymotrypsingen which would only be activated once it is out of the pancreas in the small intestines where it is needed.  If this were not the case, then the full strength trypsin would end up digesting the pancreas itself! Activation of the precursors as noted earlier can also occur after harvesting the raw pancreas all the way to the finished product in storage.

                          trypsinogen
trypsin                                               chymotrypsingen chymotrypsin

     Dr. Beard, the father of the Trophoblastic Theory, considered the pancreas' activated enzyme, trypsin (protease) to be the primary active enzyme involved in the taming of the embryonic trophoblast--keeping it from turning into a cancer. He thought the only potent way to administer trypsin was via injection as it was thought in earlier times (still to this day)  that the stomach acids would break trypsin down.  Furthermore, it was thought should any trypsin survive the stomach, it would be further degraded by the alkaline juices of the small intestines. Finally, it was still further reasoned that since trypsin was a large molecule, it would be too large to be absorbed through the intestinal walls. Wrong on all counts as it was later discovered!

      Back in Dr. Beard's day, it was not known that trypsin had a precursor or that it was not present in the pancreas in that activated form. Accordingly, Dr. Beard was unaware that what he was probably using was the precursor, trypsinogen and not trypsin. Dr. Beard made his extract quickly,  processing from fresh raw pancreas. Keep that in mind as important further down this page. The precursors are probably the most potent anti-cancer components from the pancreas, not the activated enzymes! This misconception would also hold true for those working with pancreatin years later until digestive physiology became more advanced.

    The question back in Dr. Beard's day as now is how active of a potency are the pancreatic enzymes we have access to? At the turn of the 20th century, the trypsin and pancreatin formulas on the market widely varied in quality of which Dr. Beard was quite critical. Unfortunately, not much has changed in this day and age. There is still a lot of trash out there on the open market.  Dr.Kelley approved pancreatic enzymes for his patients made using the Levin process which involved azeotrophic distillation with all fat being removed and with the precursors activated. His thought evolved into feeling that the more concentrated, activated, refined pancreatic supplements were, the better.  In contrast, Dr. Gonzalez prescribed minimally processed freeze-dried enzymes which contained the natural fats with high precursor content. Dr. Gonzalez makes a compelling defense for this and I agree. After studying Dr. Kelley's patient success rates over 20 years, he came to the conclusion that Kelley's best years were approximately the decade of 1970-1980 with many brilliant cancer case recoveries. During this time frame, Kelley was prescribing a low concentration, less refined pancreatic enzyme that contained over half as precursors versus the activated enzymes.  Dr. Gonzalez further writes that Kelley switched over to a high concentration formula in the 1980s which seemingly resulted  in the worse success rates of his 20 year career. Dr Gonzalez writes:

"But I knew from my exhaustive evaluation of Kelley's files that as he opted for a more potent enzyme formulation, his response rate fell significantly. In frustration, he assumed he only needed to prescribe an even stronger enzyme, or change encapsulators, etc, instead of retracing his steps and going backward to the less active 4x enzymes he had earlier used with great success. I became convinced that as brilliant as Kelley had been in his prime, he had erred in his later years by assuming that "purer and stronger" is always unquestionably better. I suspect that the fat depleted, highly activated supplements may have been prone to deteriorate once encapsulated, susceptible to rapid auto-digestion on the shelf. I also became convinced that the fat in the gland might not only help stabilize the mix, but provide synergistic factors to assist the proteolytic enzymes in their fight against malignant cells. Finally, I came to believe that an enzyme with less activity, with more of the total potential as precursor, might not only be more stable in the bottle but more effective against cancer. "

     Fat was too often thought of as a by-product in years past. New research suggests that fat is far more than a calorie storage device, but an active secreting organ.  As a 2013 monograph writes:  "Originally considered as simply a storage organ for triacylglycerol, interest in the biology of adipose (fat) tissue has increased substantially. Over the last decades there has been considerable accumulation of experimental data about the biology and biochemistry of adipose (fat) tissue. This tissue is no longer considered to be an inert tissue that just stores fat. Adipose tissue is a metabolically dynamic organ that is the primary site of storage for excess energy but it serves as an endocrine organ capable of synthesizing a number of biologically active compounds that regulate metabolic homeostasis." The commonly used, Levin method of pancreatic enzyme extraction that defatted the raw pancreas seems to produce an inferior enzyme formula even though Kelley did see some spectacular results with the lower concentrated 4x version. For the do-it-yourselfer, this is perfect! It allows us to conveniently minimally process the raw pancreas for the most efficient and cheapest product.  What could be better?


     The enzyme supplements you can buy out there are not guided by any government standards in processing or quality control specs. Each company is basically on its own.  As I have written previously, glands offer many challenges to the extractor and processor not found in other more hardy medicinal materials due to the delicate stability of enzymes, vitamins, fats, precursors, etc. Of the four commonly used means of processing pancreatic enzymes (azeotrophic,salt precipitation, freeze-drying, Predigestion), only freeze drying seems to be the preferred method in processing quality glandular material on a commercial level. Freeze-drying consists of freezing the pancreas to or below -40° F, placing under a vacuum and evaporating its water content. This appears to be the best process to preserve very delicate proteins and fat components with the minimum of damage. For the Do-it-yourselver, none of this is probably necessary as one can achieve the medicinal benefits from raw pancreas without needing to resort to  these commercial processes though freeze-drying systems for the home are out there and useful!The main drawback is its expense and that it will not sterilize glandular material that may be contaminated with virus, bacteria, fungi--a possible health hazard! There is really no good way to sterilize glandular material without also destroying its medicinal components. A major conundrum!

     Before freeze-drying, the Levin method of extraction was widely used and still is in the cheaper formulas.  As the patent reads:
"This invention relates to a method for producing from glandular materials and other tissues, defatted and dehydrated powders of high enzymatic activity, useful per se, or as a source of individual enzymes. More particularly, it relates to a process for recovering enzymes and activating the inactive form of enzymes in glandular tissue.  Formerly, fresh glandular substances from cattle, sheep, hogs, horses, etc., were macerated and then extracted with water solutions, dilute alcohol, dilute glycerol, or the like, to obtain a crude extract of enzymes. These crude extracts were dried or further purified by various methods described in the literature. The process must usually be carried out at low temperatures, approximately C. to inhibit enzymatic activity during preparation. Pancreatin powder, for example, is conventionally prepared by mincing pancreas with water, pressing the mixture to recover a liquid extract, and adding absolute alcohol to precipitate the active enzymatic substance. The precipitate is filtered, dried and sold as pancreatin USP and contains trypsin, amylase and sometimes lipase. By United States Pharmacopoeia (USP) standards pancreatin must be able to render twenty-five times its weight of casein non-precipitatable by acid-alcohol after incubation for one hour at 40. It must contain amylase enough to hydrolyze twenty-five times its weight of potato starch past the erythrodextrin stage in five minutes at 40. USP standards do not require lipase activity, this being the most readily destroyed of the pancreatic enzymes, but British Pharmacopoeia (BP) standards require lipase activity whereby mg. of pancreatin in 10 cc. of cream suspension incubated for four hours at 40 C. will produce acid equivalent to 1.0 cc. of 0.05 N sodium hydroxide."

The old Levin method allows the trypsin precursor (trypsinogen)  found in the raw pancreas to be converted to trypsin and chymotrypsinogen to chymotrypsin by digestion for periods of time ranging from several hours to several days at a temperature of about 15 to 45 C. As we now know this is not good for our purposes as we want the precursors intact in our preferred pancreas product. Certain enzymes exist in their particular tissues in an inactive form, such as trypsinogen and 'chymotrypsinogen in the pancreas, + in the stomach, etc. For example, if the pancreas is removed shortly after an animal is killed and the trypsin content measured, very little evidence of trypsin activity will be found. The Levin method activates the trypsinogen and chymotrypsinogen.

The Levin method also defats its final product when we want the fat to remain intact.














Pancreatic Supportive Herbal Therapy

     The pancreas has received scarce attention in herbal medicine over the years.  Herbal therapy to support and possibly regenerate the defective pancreas in the Trophoblastic Theory of cancer seems to never to have been considered by any of the practitioners of that speciality, even as an adjuvant. I consider certain herbs to be invaluable in regaining the health of the pancreas and should be used in conjunction with pancreatic enzymes in treating cancer. Dr. Christopher (1909-1983) should be a past herbalist, one looks to for some insight into how to treat the pancreas. He is rather unique in that he had a wide herbal practice as a working clinician and simply did not regurgitate herbal ideas from a book or books.  He specifically has treated the pancreas with:

1) Cedar berries (Juniperus monosperma)  . . . . . . note that this juniper berry is different from other juniper berries, but the question is, how different? It does have one seed per berry while others are multi-seeded. For instance the eastern red cedar (Juniperus virginiana)  predominates my farm and a large part of the USA has 1-3 seeds per berry. The Junipers are known to naturally contain deoxypodophyllotoxin & Podophyllotoxin which both are cancer fighters. Dr. Christopher's western cedar berry (j. monoperma) seems to directly effect the pancreas. It was used by him in treating diabetics with remarkably good success along with all other types of pancreatic abnormalities.

2) Goldenseal (Hydrastis canadensis) . . . . . . . . is a superb glandular aid

3) Uva ursi (Arbutus uva-ursi) . . . . . . . . . .

4) Licorice root (Glycyrrhiza glabra) . . . . . . .

5) Mullein (Verbascum thapsus)  . . . . . . . . . . .

6) Cayenne (Capsicum annuum) . . . . . . . . . .

Dr. Christopher's pancreas formula was formulated as 16 parts Cedar berry and one part of each of the others (uva ursi, golden seal, licorice root, mullein, cayenne).

     A 2004 Indian study, "Digestive stimulant action of three Indian spice mixes in experimental rats" came to some interesting conclusions on the stimulating effects of some herbs on the pancreas.  They found that curcumin (154%), ginger (133%) capsaicin (120%), and piperine (165%) stimulated trypsin activity from 120% to 165% when fed continually. If only fed once, then effects were less with ajowan (18%), fenugreek (13%) and fennel (17%) having the most stimulation power. Chymotrypsin was stimulated the maximum of 73% with curcumin though asafoetida (45%), fenugreek (43%), ginger (30%), onion (15%) and piperine (30%) also showed significant activity when these herbs were incorporated into the diet with continued intake. If given only one time, stimulating activity was less with coriander having the most chymotrypsin stimulation at 15%.









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