18 July 2019

NORI Protocol

Scientifically unconfirmed cancer treatment with a fruit diet, marketed by a self-proclaimed "specialist"

David Gorski, Science-Based Medicine: The NORI protocol: An unproven fruit-based nutritional treatment for cancer sold by a self-proclaimed “expert” Translated by Alexander Gorlov, XX2 century

Mark Simon is the founder of the Nutritional Oncology Research Institute (NORI). He is not a Doctor of medicine (MD), not a doctor of osteopathy (DO), not a doctor of philosophy (PhD). (And not even a doctor of naturopathy (ND)!) However, he claims that he has created a dietary protocol, using which it is possible to cure cancer. Is it possible? (You seem to know the answer to this question).

NORI Protocol: there is so much quack nonsense that you need to put red flags everywhere

What is the NORI protocol? In fact, it is a fruit diet enriched with selenium. And she was born in NORI – Research Oncological Institute of Nutrition. On the main page of the NORI website, visitors are treated to the following description of the "institute":

"NORI is an independent research organization that has developed non–traditional methods of cancer treatment, which are not based on the use of toxic drugs, surgery and radiation. Cancer patients who avoid traditional forms of treatment or have exhausted all other options may want to get acquainted with the revolutionary and unique approach to cancer treatment offered only by NORI. The NORI program is designed to be the most attractive among the available alternative methods of cancer treatment in terms of its cost. NORI represents the future of safe and comprehensive cancer treatment in the most healthy, effective and scientifically sound way."

That's so many red flags. And everything is right on the main page. Firstly, the quack trope about cancer treatment, which is based on "the use of toxic drugs, surgery and radiation". Secondly, a statement about the use of this treatment instead of the usual one. Thirdly, the statement in which NORI is presented as "the future of safe and comprehensive cancer treatment in the most healthy, effective and scientifically sound way", whatever that means.

And here's another:

"NORI is an organization focused on the research and development of dietary cancer treatments that are non–toxic and do not require the use of medications. NORI has developed a unique treatment protocol that can be used together with traditional therapies or separately from them for the treatment of almost any form of cancer and at any stage. The NORI protocol is based on a special plant-based diet, which allows the use of safe and effective natural compounds that selectively kill cancer cells. The NORI protocol has proven its effectiveness in the treatment of a wide range of oncological diseases at all stages."

I love it when representatives of alternative medicine, advertising their goods, claim that their form of treatment "has proven effective in the treatment of a wide range of oncological diseases at all stages." When I meet such statements, I always ask: where are the facts? Where is the science? Where are the randomized controlled clinical trials? As will be shown below, all this, without which the NORI protocol cannot look solid, to put it mildly, is not enough. However, if you look at the NORI web page dedicated to its protocol, you will find links to many carefully selected studies, but most of them are in vitro, or only phase I and phase II clinical trials have been completed, and there is no randomization on the second one. (By definition, it is absent in phase I). You will also find many reviews. I will speak about them later, with one exception. Here is a review by Amy H. from Los Angeles:

"In January 2014, I was diagnosed with DCIS (Ductal carcinoma in situ, ductal carcinoma in situ), stage 0, breast cancer. The surgeon wanted to give me a mastectomy followed by a skin flap transplant, believing that no other treatment would allow me to survive and maintain an attractive appearance. What a blow! I decided to use the services of a naturopath, and thanks to him, my well-being improved at all levels. However, despite the obvious improvement in health, something has grown on the chest. I was told that it was a scar from a biopsy, but by the end of 2016, the growth had significantly increased. I suspected that it was not a scar, but a tumor, and I began to read more about cancer. As a result, I had doubts about the effectiveness of what I was doing for treatment. Of course, I went for an ultrasound, and they told me that I had stage four breast cancer. After pushing around, I found out about the NORI protocol and met Mark Simon. He explained to me very clearly what cancer is and how to treat it. I had to communicate with unapproachable doctors, and he was approachable, tried in every way to support me and helped me to follow a path that does not disgust my instincts, relieved me of fears and made me feel like an active participant in my healing. Although I am new to the protocol, I am full of hope and feel that I am being very competently guided."

This review is horrifying, and on many levels, and it amazes me that dealers of alternative dietary drugs for cancer use this kind of reviews as advertising. Those of you who have been attending SBM for a long time know that I keep wondering if we diagnose DCIS too often and whether our forms of treatment for it are too harsh. However, this does not mean that DCIS is not dangerous. The point is different: since we do not know if she has reached the stage of invasive cancer, we consider it our duty to treat her at any stage. However, being a specialist in the removal of breast tumors, I can read this review between the lines. Since the surgeon who examined Amy H. recommended a mastectomy, it means that DCIS has already spread so much that breast preservation surgery was impossible. This is a high-risk DCIS. Therefore, it is not surprising that Amy's cancer turned out to be invasive. As for the cancer of the fourth stage, it is unclear to me how it was possible to diagnose it by conducting only an ultrasound session. Unless ultrasound detected liver metastases. Anyway, this review shows us a woman with high-risk DCIS who refused standard treatment in favor of the one offered by a naturopathic charlatan, who watched her cancer progress during this treatment (And after all, she saw the growth of the tumor, but attributed it to the scar left after the biopsy!), and then chose another dubious treatment that did not give anything good, except "hopes" and "competent" guidance.

It's time to discuss the NORI methodology in more detail. First, let's turn to the identity of its creator Mark Simon, and then consider the protocol itself. It includes a fruit diet, the task of which is to cause an acute shortage of methionine in cancer cells, an amino acid that is said to increase the sensitivity of cells to selenium. Of course, not any selenium is needed, but only its special form. Other selenium will not work.

The creator of the NORI protocol is Mark Simon

Perhaps there is no better way to introduce Mark Simon than to use his interview 2015 with Chris Wark about Chris's glorious victory over cancer (a 37-minute video with two English–speaking heads - VM). As I have already told you, Mr. Wark has composed a story that is by no means original and resembles an anecdote. In it, he mistakenly attributes his recovery to improper treatment. In general, he had stage three colon cancer, underwent surgery, and then refused the recommended standard chemotherapy. As very often happens in such cases, he decided to find a quack form of treatment for himself and, when he succeeded, he began to claim that his health improved thanks to this treatment, and not a surgical operation during which a cancerous tumor was removed. Now he has a website and an Internet business on the topic of alternative cancer treatment: he sells books and "manuals", and also uses all sorts of dubious reviews to better sell his products. A great couple turned out!

From this interview, we can learn that Mark Simon has long been interested in alternative medicine, but there is no detailed information about his professional experience here. It is said only that he has experience in the field of neurobiology and biomedical engineering. Great! But it was not easy to find out the details. I had to Google a lot before I managed to get to web pages like this, where I was informed that Simon's track record includes the title of "health coach" (health coach) and a certificate of the right to prescribe dietary nutrition (Clinical Nutrition Certificate) issued by the Institute of Natural Healing (Natural Healing Institute). In his LinkedIn profile there is nothing about his activities before 2011, that is, before he founded NORI, and only positions in this institute are indicated. What else did you find? Gene Fuss posted a post on Facebook, on the "Truth about Cancer" page, where, noting that Simon "studied neuroscience, biomedical engineering and dietary nutrition and has been a vegan for 32 years," attributed to him "DEEP knowledge about the biology of cancer tumors, better than anyone else No one I've met."

If the statements about the NORI protocol made in the video above and in another (nauseatingly promotional-VM) had at least some scientific significance, I would not mind discussing Mark Simon's "deep knowledge" about something related to cancer or dietary nutrition.

Even without having a solid knowledge base, it is easy to understand that, from a scientific point of view, the statements contained in the above videos and on the website of the NORI protocol are at best very dubious, and at worst – clearly quackish. As for Simon's professional experience, I would like to know why, being a specialist in the field of neurobiology and biomedical engineering, he does not trumpet his achievements, his scientific degree and his scientific activities? He is clearly not MD, PhD, or even ND (even considering that this abbreviation, in my opinion, should not mean "doctor of naturopathy", but "not a doctor"). If he had any of these degrees, he would, of course, reflect this in his biography. But there is no such information, and in return – vague statements. It seems to me that he received a bachelor's or master's degree in some scientific field and/or worked as a laboratory assistant in some laboratory conducting research in the field of neurobiology and/or biomedical engineering. Simon, of course, can refute my assumptions by listing his diplomas and telling about his respectable scientific activity until 2011.

And now–Simon's protocol!

NORI Protocol: Methionine deprivation and cancer treatment with selenium!

From the videos above, we know that Mark Simon was inspired by someone named Daniel Epner, a doctor who taught at Baylor College of Medicine and published an article about methionine deprivation in 2001. It was this article that prompted Mark Simon to look at the restriction of methionine as a means of treating cancer. A search in PubMed gives 36 articles by Daniel Epner, and the last one – about methionine and cancer – dates back to 2003. The restriction of methionine, it shows, can be aimed at the synthesis of thymidylate synthase, an enzyme that plays a key role in the early stages of DNA biosynthesis. In this article, the author's generalization of the results of cell culture and animal studies, which demonstrated that methionine restriction can have an antitumor effect on a number of cancer cell lines and model animals, is of interest. Of course, we all know how difficult it is to use such discoveries to treat people. As Dr. Epner notes, a phase I study was conducted to show the efficacy and safety of methionine restriction in conjunction with chemotherapy.

Interestingly, now Dr. Epner is not a practicing oncologist. He moved from Baylor College to M.D. Anderson Cancer Center, whose website says:

"Dr. Epner is a palliative care physician at the M. D. Anderson Cancer Center. For several years he was a practicing oncologist, and in 2012 he became a lecturer at the Faculty of Palliative Care. He began his teaching career at Baylor College of Medicine, where he held the position of chief researcher of the Laboratory of Basic Sciences, but now he is studying the psychosocial aspects of oncology. His main scientific work is teaching communication skills to fellows specializing in oncology, palliative care and other fields."

Interesting career trajectory!

It turns out that, in fact, Mark Simon is an enthusiastic evangelist who was so carried away by an interesting discovery made in the field of cancer cell research that he, picking up this discovery, hurried to throw himself into the abyss of cancer treatment with him. This is evident from the way Simon describes the NORI protocol he created. In fact, in his statements, science takes a monstrously simplified form. Simon extrapolates data from studies of cell cultures and model animals to humans, although the validity of such extrapolation has not been scientifically proven. At the same time, the creator of the NORI protocol himself did not conduct any serious research, but simply pulled a number of facts from the literature and summed up a ridiculous base for them. Here is an example:

"There are two types of DNA in human cells: nuclear and mitochondrial. Cancer appears to be the result of damage to mitochondrial DNA, whereas damage to nuclear DNA occurs after the onset of this disease. Damage to mitochondria prevents apoptosis, a natural programmed cell death. Apoptosis is a normal process that affects the cell so much that it loses the ability to divide indefinitely. Cancer is the same state of cells regardless of the place in which it manifests itself or the organ in which it originated. Cancer is not 200 different diseases. This is a process determined by general metabolic disorders in malignant cells, and these disorders can be effectively eliminated without resorting to toxic drugs. As a rule, the life of an oncological patient is carried away by the side effects of traditional therapy, and not the cancer itself."

Whenever someone tells you that most cancer patients die because of the toxicity of traditional treatments, know that the probability that you are dealing with a charlatan is at least 99.99%. Well, yes, cancer has a metabolic aspect. Cancer cells are not only damaged genomes, but also damaged metabolic pathways. (I love using scientific terms so much!) This does not mean that cancer is a single disease and that the mutations that cause it are nothing.

And the NORI website also states the following:

"The key difference between the NORI approach and other methods of cancer treatment based on dietary nutrition is that NORI seeks to limit the intake of nutrients necessary for their existence into cancer cells, while providing a full nutrition of healthy cells. The NORI diet is not designed to build or strengthen the immune system. Cancer cells, like normal ones, have built-in defenses against attacks by the immune system. Most alternative cancer treatments differ from traditional ones by selectivity of action. This means that unlike traditional treatments that destroy healthy cells, alternative methods try to protect them."

Well, this is an original alternative therapy that does not pretend to "strengthen the immune system"!

The idea of the NORI protocol is as follows. First of all, with the help of a fruit diet, it is necessary to limit the intake of methionine into cancer cells, since many of them are sensitive to such a restriction. (There is little methionine in fruits). Of course, the time of dieting should be "individualized". And, of course, Simon does not want to discuss what criteria are used to determine this recommended time for each patient individually. He says so:

"In each case, the restriction of methionine should be individualized. It depends on the patient's weight, nutritional status, disease development and past dietary preferences. Depending on individual circumstances, a diet with a limited content of methionine can be followed continuously, or cyclically with breaks between cycles. The restriction of methionine provides for the rejection of many products and the use of mainly fruits. Natural sugar, which fruits contain, does not nourish cancer cells and does not promote tumor growth. It is often mistakenly believed that fruits are sugar, and, therefore, increase blood sugar levels. Fruits can be a problem with a high level of fat intake (more than 10% of total calories), because fats cause insulin resistance."

Perfectly! Now give me the protocol together with the evidence base confirming the scientific nature of its specifics.

I am particularly fascinated by how famously Simon got rid of the statement "sugar nourishes cancer cells", with the help of which they attract attention to new diets: he simply stated that "natural" sugar, which fruits contain, does not nourish cancer cells if you do not consume a lot of fat and do not develop insulin resistance. So, yes, his NORI protocol also requires that the food be low in fat. In addition, it is interesting to note that for some reason Simon focused on fruits, although vegetables are also low in methionine. Problematic for its protocol is the fact that normal cells, as well as cancer cells, need methionine. This is a vital amino acid that the human body does not synthesize, which means that it cannot be completely excluded from the diet.

At the next stage after methionine restriction, the patient can take food with a high content of this amino acid. The idea is this: by limiting methionine, we stop the growth of cancer cells and the change of periods of their cell cycle, and then, by removing the restriction of methionine, we allegedly force the cells to grow again, and cause their apoptosis (programmed death). This main idea is based on two others: firstly, the restriction of methionine increases the sensitivity of cancer cells to selenium and, secondly, digestive enzymes that enter our body along with fruits also fight cancer.

Looking at the full list of "chemotherapeutic agents" of the NORI protocol, you will find sodium selenite, selenomethionine, vitamin K3, shikonin (obtained from the bark of gromwell root), vitamin E succinate, pine bark, grape seed extract, green tea extract and a number of other substances. In fact, all the "scientific" statements that can be heard in the Simon videos above and read on the NORI protocol website, in my opinion, should be called "seductive verbiage". It is similar to the technobabble of "Star Trek" (Star Trek technobabble), only in addition it contains seduction.

And is there any evidence that methionine restriction actually promotes cancer treatment? Answer: yes, but not enough. After reading the latest review articles about methionine restriction and cancer (for example, this, this and this), you will find that 18 years have passed, and scientists are still researching the topic you are interested in, and clinical data confirming the effectiveness of methionine restriction in the treatment of cancer is sorely lacking. And you will also learn that, according to some data, the restriction of methionine can increase life expectancy. Next, you will find articles where it is recommended to conduct clinical trials, which, it seems, have not been conducted. In addition, you will learn about methioninase. This is a complex substance that breaks down methionine and, therefore, can be used to limit it. There are results of the study of xenografts (clinical samples of human tumors grown in mice), but, again, there is a shortage of clinical data.

However, for Simon, the picture is very clear:

"Why are alternative treatments, such as the NORI protocol, not practiced by oncologists and not studied in clinical trials? The answer lies in the economy and excessive control by the pharmaceutical industry. Money and profit have become the main driving force of all medical research. Medical science should serve all of us, not the interests of multinational corporations. NORI is an alternative cancer research institute created on the initiative of ordinary people, which paves the way to medical sanity in oncology."

Is it not because it does not work out in any way that it is extremely difficult to develop this kind of dietary treatment? Oh, no! There must be a conspiracy of Big Pharma here. That's why NORI sells a line of nutraceuticals (dietary supplements), including – of course! – CBD oil. It is not surprising that the NORI protocol contains the following caveat:

"The U.S. Food and Drug Administration has not evaluated any of the NORI nutraceuticals claims. NORI nutraceuticals are not intended for the diagnosis, treatment or prevention of any diseases. NORI nutraceuticals are provided as part of the supplemental nutrition program and are not an alternative to traditional means of providing medical care."

Well, yes, it's a quack version of Miranda's legal rule! As in many other cases of oncological quackery, Simon took interesting scientific observations that had not yet had time to pass the test, and, without any hesitation, gave them an extremely broad meaning.

Reviews – more than enough!

So, all the science that Mark Simon uses is just tendentiously selected scientific facts. Is there anything else at his disposal? Like all self-respecting supporters of alternative cancer treatment, he has reviews! And the review gained the most fame Candice-Marie Fox, who claims that using the NORI protocol, she got rid of thyroid cancer (two more talking heads – VM).

Here's what we know from Ms. Fox's words: in 2011, a few days before her 28th birthday, she was diagnosed with stage III thyroid cancer. If you Google a little, you'll find a few things. Firstly, she had papillary thyroid cancer, which is the most common and most curable form of cancer of this organ. Given the fact that this cancer is too often diagnosed during ultrasound examination, some even suggest in some cases not to treat it. (I doubt that one of these cases took place here, because Mrs. Fox claims that she had a lump on her neck). Secondly, there is no stage III papillary thyroid cancer in a 28-year-old person. At this age, the highest stage is the second, even if there are distant metastases. The survival rate in such a cancer is very high: almost one hundred percent five-year survival in localized and regional forms of the disease and 78% in the presence of distant metastases.

Thirdly, Ms. Fox underwent a standard surgical operation – a total thyroidectomy and, it seems, dissection of the central lymph node of the neck, for a tumor. And about the third minute of the video, she says that she was diagnosed with cancer again, and with metastases in the lungs, lymph nodes of the neck and in other places. According to her, the doctors offered her to undergo radiation again in 6-9 months, and if it does not help, chemotherapy. Here the antennae of my skepticism began to vibrate vigorously again, because, as far as I know, only radioactive iodine is used to treat metastatic papillary thyroid cancer, and chemotherapy is not used.

I am not the only one who has seen holes in Ms. Fox's story. There are a number of inconsistencies noted Auma (Auma, blog host Reality Based Medicine), who introduces herself as "an evil troll, an employee of Big Pharma and a secret agent of the government." Relying on articles in the press and on Ms. Fox's own statements posted on Facebook, she found several ridiculous or misleading statements about the diagnosis and "natural treatment" in her:

"The cancer has spread to the liver." After the cancer survivors of the trolls began to bother Mrs. Fox with their questions on Facebook, she admitted that the tumors in the liver that she mentions Daily Mail, were benign.

"Stage IV". A few days ago, Ms. Fox said on Facebook that she had never talked about the stage IV cancer she had been diagnosed with. If so, where did the journalists get this stage (in one of the publications – "degree")? And another thing: papillary thyroid cancer in people younger than 45 years old is only stage I or II, and the five-year survival rate is almost 100%.

"Mark Simon is an oncologist, not a quack nutritionist without a medical degree." On Facebook, Ms. Fox admitted that Simon was just a nutritionist, and the Daily Mail made an appropriate correction.

"Refusal of chemotherapy." In various sources, Candice mentions her refusal of radiotherapy and chemotherapy. It is very strange, because chemotherapy is not usually used as part of the first-line treatment of papillary thyroid cancer. However, according to Ms. Fox's stories, it looks like she was definitely offered chemotherapy, and she categorically refused.

The most important of the statements made by Ms. Fox is her "final diagnosis", after which she managed to live for five years. I don't know if she believes that everything was exactly like that, or is deliberately exaggerating, attracting attention to herself and trying to extract material benefits from a beautiful story about cancer. This is what I would like to find out the most. Please keep in mind that I am not a doctor, but a patient who has well remembered the treatment process. If you are a medical specialist, then after reading this, please add your comment. In addition, since I am not from an English–speaking country, I constantly call thyroglobulin TGB - as is customary with us. In English documents, the name of this drug is usually abbreviated differently: Tg.

And Auma also took some screenshots of what Ms. Fox wrote on Facebook during the period of time when she was undergoing treatment. As can be seen from these records, she subsequently overlooked a lot of interesting things. Both posts, while they are there, are worth reading – because of the high level of detail. The gist of the whole story is that Ms. Fox was cured thanks to conventional therapy, not the NORI protocol, but she attributes her "healing" to dietary intervention.

What about other reviews? Most of them have one thing in common: it is clear that the cancer was cured in the traditional way. There are patients with colorectal cancer who underwent surgery but refused chemotherapy (for example, Chris Work). There is a patient with recurrent Hodgkin's lymphoma who has undergone chemotherapy and the NORI protocol, but attributes the recovery exclusively to NORI. There are a couple of evidences of prostate cancer, which are rather doubtful due to the very variable and often painless course of this disease. And there was also a review of a man with metastatic pancreatic cancer who regressed thanks to the NORI protocol and, of course, chemotherapy. The fact that this man and his wife associate successful cancer treatment only with the NORI protocol is extremely depressing to me. I wonder if they will scold this protocol when the disease worsens again, and this will almost certainly happen if in this case there really is a pancreatic adenocarcinoma.

NORI Protocol: a super-profitable idea

If there is something in common in different forms of oncological quackery, it is the involvement in quack affairs of preclinical (that is, not yet tested in clinical conditions) science or inadequately tested clinical science and its exploitation. In other words, cancer charlatans take a gray area of science and illegally advertise it as not gray in order to sell the treatment they invented. Does the NORI protocol harm cancer patients? Probably not, but it's hard to say this categorically. Food manipulation is not very safe. Does this protocol cure cancer? The literature I have read does not allow me to give an unambiguous answer. The effectiveness of the protocol has not been proven, and the road leading from experiments with cell cultures and rodents to effective forms of cancer treatment is littered with fragments of ideas that seemed promising.

In this case, the gray area is a limitation of methionine as a treatment for cancer. According to data obtained during preclinical studies of cell cultures and model rodents, this dietary intervention can be an effective form of cancer control, but to this day there is no convincing evidence of its effectiveness in the treatment of humans. Is methionine restriction able to take part in the treatment of cancer in humans? It is not excluded. I can confidently say only one thing: if ever randomized controlled clinical trials show that methionine restriction can increase the effectiveness of chemotherapy, the scientifically based protocol will almost certainly have very little similarity with the NORI protocol, which was invented by the charlatan Mark Simon. Simon, having oversimplified science (recall, for example, his statement that cancer is a single disease, and a metabolic one), added complex inventions to it (for example, selenium and a bunch of various additives, the mystical "individualization" of methionine restriction) and received a protocol that, thanks to desperate cancer patients, makes a huge profit.

Not surprisingly, naturopaths are very fond of the NORI protocol.

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