Ever since I started promoting the benefits of vitamin D there has been a small but vocal minority of advocates of what is referred to as the "Marshall Protocol".
As much as I would like to ignore it due to its lack of validity, I can no longer do so, because so many people are using this information and at the very least, they are placing their health at great risk and in many cases they are damaging their health.
Therefore, to remain silent would be irresponsible, so I am going to address this issue once and then put it to rest.
I felt it was important to share my views on what I perceive is a dangerous view of vitamin D physiology. It has been my common strategy for as long as I have been in medicine to be open to new ideas and concepts and I have carefully evaluated Dr. Marshall's protocol and even attended one of his lectures in Chicago nearly ten years ago.
It was somewhat comical to attend his seminar as most of the people attending were wearing very large, wrap around UVB blocking glasses typically worn after cataract surgery. I knew at that point that the operating premise was seriously flawed. The belief that ANY exposure to the sun was dangerous and needed to be avoided gravely concerned me.
"Dr." Marshall is Not a Physician
For those of you who are not familiar with the protocol recommended by Trevor Marshall, I will briefly summarize its basic tenets, as I understand them, before going on.
First it is important to note that Dr. Marshall is not a medical doctor but has his PhD in Biomedical Engineering.
Marshall is an Australian electrical engineer who developed an interest in biomedical engineering out of a desire to cure his own sarcoidosis, which he developed in the 1970s[i]. He has no medical degree. His theories come from mathematical molecular models, not clinical studies.
Sarcoidosis is Only Disease Where Vitamin D Levels Are an Engima
Sarcoidosis is an inflammatory condition that produces tiny lumps of cells called granulomas in various organs of the body. These granulomas clump together into large or small groups, resulting in organ damage. They most commonly occur in the lungs, lymph nodes, skin and eyes, and symptoms can wax and wane over many years.
Symptoms can vary from very minimal to life threatening. Some medical experts believe sarcoidosis is an autoimmune process, and others believe some substance or pathogen has triggered the inflammation. There is no agreement yet about the cause of this illness.
Marshall states the treatment he developed has cured his disease and claims that his protocol, the Marshall Protocol (aka MP) will cure a long list of chronic inflammatory and autoimmune diseases. According to one of his most vocal advocates, Amy Proal[ii], the MP cures sarcoidosis, Chronic Fatigue Syndrome (CFS), fibromyalgia, Crohn's disease, and rheumatoid arthritis (RA), and many others.
Marshall proposes the following:
All chronic diseases are the result of infection by certain bacteria that hide out and proliferate inside the cytoplasm of the cells they infect. These cells include macrophages, the very cells of the immune system the body uses to kill invading pathogens. Once inside these cells, they generate the release of inflammatory cytokines, which cause the person pain and/or fatigue.
The infected cells sustain themselves by congregating into communities called biofilms, which produce a protective matrix that allows them to more effectively evade the immune system and resist antibiotics.
The reason these bacteria are able to proliferate in this way is directly related to vitamin D. Marshall argues that vitamin D is immunosuppressive—it effectively shuts down your body's immune system. Therefore, he states, the lower your vitamin D is, the better, because vitamin D from any source (food, supplements, or sunlight) in any amount drives the disease process.
The low vitamin D levels [meaning serum 25(OH)D] found in many people with chronic diseases are a result of the disease, rather than the cause. Marshall explains this by saying that the disease process causes 1,25-D to rise to an unnaturally high level. This in turn causes a cascade of reactions leading to a drop in 25(OH)D, leading to the low blood levels we observe in blood tests.
Given these premises, his treatment plan consists of the following:
Avoid sunlight and vitamin D as if they were the plague. He restricts people from eating foods high in vitamin D, as well as having them hole-up inside for months on end. If they go outside, they cover up completely, including wearing special sunglasses.
Patients take a medication called Benicar (olmesartan), which is an angiotensin II receptor blocker (ARB). This is supposed to reactivate the immune system by opening up the VDRs (vitamin D receptors), allowing the body to once again manage the infections.
Patients concurrently take pulsed, low-dose antibiotics to further combat the infection.
The protocol is continued for 3-5 years. Before patients begin to feel better, they can expect to feel much worse due to the "Herx" reaction (Jarisch-Herxheimer reaction). Herx is the effect of bacterial dye-off, releasing toxins into the bloodstream, stimulating the production of inflammatory cytokines, which make the patient feel bad.
So, Marshall believes, if you don't feel bad, it's not working.
Why One Size Doesn't Fit All
Probably because Marshall is an engineer and not a physician, his approach reveals a lack of appreciation of the complexity and variation of the human system. Your body is not a piece of electronics that can be predicted to act a certain way every time. A radio is a radio is a radio, but not so with the human body. It is more than a sum of its parts, making medical science as much an art as it is a science.
This is precisely why clinical trials are necessary before conclusions about causation can be drawn. There are simply too many variables.
What Marshall has done is take conclusions from his research for a cure for his own condition (sarcoidosis), and then applying it to everything from soapsuds to unicorns. The error in logic would not be so disturbing were it not for the fact that he is doing a lot of harm to people who desperately seek help for their pain.
Our Ancient Ancestors Had Constant Sun Exposure
First, let me address the most basic premise here—that vitamin D and sunshine promote disease. Besides being contrary to current research, this goes against our evolutionary history.
Our ancient ancestors had regular and consistent sun exposure as they were from sub tropical environments and did not spend nearly all day indoors like most of us do when we work. We've spent thousands of years hunting and gathering outdoors, particularly in equatorial regions, and most of that time we certainly wore far less clothing than we wear today. It makes no sense that we would have developed the need to avoid sunlight altogether.
Nature has designed a system in which humans go into the sun, make thousands of units of cholecalciferol, which the liver then converts to 25(OH)D. Our organs then make a steroid hormone, 1,25-D, which helps to regulate genes in every organ of the body[iii].
As Dr. John Cannell, Executive Director of the Vitamin D Council, says, "We assume nature created this for a good reason."
Inflammation Requires Holistic Approach
I can agree with Marshall on the idea that inflammation is a major underlying factor in many chronic diseases. However, ,inflammation must be addressed with a holistic approach that includes diet and nutritional type, exercise, sleep, stress, psychological factors, environmental toxins, and many other things. None of these is mentioned, that I can find, in the Marshall Protocol.
And it is my firm belief that medication should rarely if ever be the first avenue of treatment for anything. Most healing can be achieved by supporting your body's own ability to heal itself by strengthening your immune system.
The Antibiotic Issue
Taking antibiotics for years, as directed by the MP, is just ludicrous and is an invitation for disaster.
There are certainly times when antibiotics are necessary, but they are widely overused. For every time they are used appropriately in traditional medicine, there are at least 10 to 20 times when they are inappropriately used, and this is what has resulted in antibiotic-resistant bacteria.
Marshall claims that, by "pulsing" several different antibiotics, antibiotic resistance is avoided. However, there is evidence to the contrary in the literature.
Mark London, of MIT, has written a very detailed, comprehensive analysis of the MP[iv]. He states that overuse of macrolides (Zithromax, clindomycin, and others) is known to result in resistant bacteria, and the risk is even higher when macrolides are combined. There is also cross-resistance between macrolides. Therefore, Marshall's claim that his protocol prevents antibiotic resistance is false.
In the past I have used antibiotics for rheumatoid arthritis when I was applying Dr. Thomas Brown's protocol. Even though Dr. Brown clearly helped many thousands of patients with this, after using it for many years I realized that even better results could be achieved without the use of antibiotics.
If infectious agents do underlie disease, which is certainly possible but remains to be proven, antibiotics are not the answer. There are many natural choices for anti-infectives that are much safer and have fewer side effects than antibiotics.
For example, for thousands of years, Chinese medicine has been curing infections with herbs, mushrooms, bark, and other natural agents.
If you have an infection, your best strategy is to get your immune system into shape by addressing the things I mentioned above, none of which are addressed by the Marshall Protocol.
"Herx" Reactions, or Something More Ominous?
Jarisch-Herxheimer reactions are a major part of what patients are told to expect once they begin the MP.
The MP teaches that, in order to know that you have one of these infections, you go onto the MP, and if you have a Herx reaction (which they basically define as feeling bad in any number of ways), you can conclude you're on the right path. By the same token, they say, if you don't "Herx," then you don't have an infection.
However, Herx reactions are known to occur only with certain types of infections such as Lyme and syphilis. They normally occur only early in treatment and typically last a few days or weeks, not months or years, and only in some people—not in all people3[v][vi].
Therefore, any test that is based on whether or not a Herx reaction occurs is meaningless, since the lack of a reaction doesn't rule out the presence of an infection. Similarly, an increase in your symptoms doesn't necessarily mean you're having a Herx reaction.
So-called Herx reactions can be explained by well-documented medication side effects. For example, Minocycline has been known to cause dizziness and nausea in some people. Benicar has many documented side effects at much smaller doses than what the MP calls for, including headaches, chest pain, muscle pain, and coughing.
How do you know that your "Herxing" isn't just a reaction to the Benicar?
Also, the MP can cause an elevated PTH level (Parathyroid Hormone), which in itself can cause symptoms of fatigue, poor concentration, irritability, depression, insomnia, headaches, and palpitations[vii].
To say that everyone who has any increase in symptoms while on the MP is just having a "Herx reaction" is simply ignorant and foolhardy, as well as negligent as it causes the patient to ignore potentially dangerous signals that something else could be wrong!
This is just what happened to a man by the name of Steve Carroll. Mr. Carroll is someone who tried the MP and nearly died of Addison's disease, as a direct result of the Marshall Protocol. His symptoms were of a growing adrenal crisis. However, the MP advisors told him that he was simply "herxing."
When he consulted his own physician, who took him off the protocol and saved his life, Mr. Carroll contacted the MP "forum" advisors[viii]. He was met with nothing but resistance and denial, and told that his own physician was wrong. The Marshall forum advisors refused to even consider the possibility they might be wrong, and that using Benicar with people who have weak adrenal function (namely low cortisol and aldosterone production) is very dangerous and can lead to an adrenal crisis.
A documentation of the dialog between Mr. Carroll and the MP folks is quite telling and has been posted verbatim online[ix].
As Mr. London writes:
"Giving a medicine to see if a person will get better from it, and then continuing that medicine due to the fact that a positive benefit occurred, is of course extremely common. However, giving a medicine specifically to see if a person will get worse from it, and then continuing that medicine because this occurred, is quite rare.
While it's true that many medicines will first cause side effects before the positive benefits occur from it, these side effects are almost never considered to be a sign that the medicine is the proper medicine to use to treat a person."
Measuring 1,25-D is Like Herding Cats
Marshall states that 1,25-D levels are elevated in people with chronic infectious diseases. [Remember, 1,25-D is the active form of vitamin D, once it's been converted from 25(OH)D.]
He relies on 1,25-D levels as indicators of the disease process. However, 1,25-D values can fluctuate tremendously up and down for many reasons, other than disease processes. 1,25-D is influenced by calcium, phosphate, and PTH, just to name a few, which makes it meaningless to use it as a marker for dysfunctional vitamin D production or regulation.
In fact, some studies show little to no correlation between 1,25-D and 25(OH)D levels[x][xi]. Many body tissues have the ability to generate 1,25-D themselves, as a way to self-regulate, rather than solely relying on serum 25(OH)D.
This is why the standard used by the medical community for assessing health is serum 25(OH)D, which is not subject to these variables and fluctuations. This test has been standardized, recognized and used by every vitamin D expert in the world. I have talked to many of the leading vitamin D researchers and not one of them had anything favorable to say about the misinformation Marshall is promoting.
What about the Cancer Studies Cited by MP Advocates?
On her website called Bacteriality, Amy Proal mentions a number of cancer studies that reportedly demonstrate that vitamin D does not decrease cancer risk. Upon close inspection, however, several of those studies involve people supplementing with very low doses of vitamin D, lower than what is considered effective by most vitamin D experts. The supplementation levels are 600-800 IU per day, which is too little to prevent much of anything.
Dr. John Cannell, one of the foremost experts on vitamin D today, scripted a response to the MP, which he sent out in his newsletter[xii]. He makes the point:
If Marshall's hypothesis is correct, that low vitamin D levels are the result of disease, then he is saying that cancer causes low vitamin D levels, not the other way around. The problem is that Professor Joanne Lappe directly disproved that theory in a randomized controlled trial[xiii] when she found that baseline vitamin D levels were strong and independent predictors of who would get cancer in the future.
The lower your levels, the higher your risk. Furthermore, increasing baseline levels from 31 to 38 ng/ml reduced incident cancers by more than 60% over a four-year period. Therefore, advising patients to become vitamin D deficient as the MP clearly does, could cause some patients to die from cancer.
It is worth noting that the amount of vitamin D subjects in the Lappe study received was 1,100 IU per day, higher than any of studies cited as negative toward vitamin D, and this study was of longer duration.
Can Any Value Be Found in Marshall's Work?
Marshall arrived at most of his theories from his personal battle with sarcoidosis, and he certainly can't be faulted for taking an aggressive approach to finding a solution for what is traditionally viewed as an incurable disease. After all, many serendipitous discoveries in history came about in unusual ways.
I strongly believe his efforts have gone astray, however, in assuming all those other chronic diseases fit the same model.
Sarcoidosis is a condition marked by abnormal immune responses, one of the many unique features of that condition. For example, according to Dr. Cannell, in sarcoidosis, the body can't regulate activated vitamin D production, resulting in hypercalcemia12. But these immune responses are not found in all of the other inflammatory conditions, so any treatment effective against sarcoidosis is thus treating a rather unique condition and may not necessarily be as effective for other conditions.
If the MP does indeed help some people with sarcoidosis and various other conditions as it seems to, based on some people's reported experiences on the web, there is no guarantee it is working in the way Marshall assumes it is.
For example, Benicar and the various antibiotics all have various effects, both positive and negative, on various conditions, which could be one explanation for why some folks feel better. Benicar has been shown to have some anti-inflammatory properties, among others. Some antibiotics have anti-inflammatory and analgesic effects themselves (minocycline, for example).
It could be this effect that makes patients feel as if they are getting better. If so, patients might experience a recurrence of symptoms once the meds are discontinued.
What About Melatonin?
Since light suppresses melatonin, it would be expected that melatonin levels would rise when you avoid light. Melatonin has significant effects on your immune system. In fact, in 2006, a study showed that melatonin was a safe and effective treatment for sarcoidosis![xiv] Melatonin has also been shown to help other conditions, including CFS, fibromyalgia and colitis.
How does anyone know it isn't the melatonin that is causing some people to feel better? If so, there are much better ways to increase your melatonin level than by sacrificing sunlight and valuable vitamin D!
The point is, there are many other factors that could explain why the MP could seem to help sufferers of sarcoidosis, besides the one he claims. To really determine what is causing what, a series of controlled studies would have to be done. He has drawn a lot of conclusions without the clinical studies to separate out the variables.
I believe that Marshall is placing people's health at risk by having them participate in a clinical trial via the Internet--and a badly designed one at that—with inadequate details and precautions about what the health consequences might be.
Stick to what you know works, and if there is merit to any of Marshall's theories, studies will bear that out in time. It would seem that the only indication for MP would be sarcoidosis. I believe it would be unwise to use it for other conditions, but even for sarcoidosis there are a number of effective non-drug approaches to address it.
I would have to agree with Dr. Cannell that you would be hard-pressed to find any reputable person in the vitamin D field who takes Marshall's theories seriously. They are poorly substantiated and lack corroborating evidence.
Go with what you know. Health comes from getting back to the basics…nutrition, exercise, restorative sleep--and yes, appropriate exposure to sufficient sunshine to normalize your vitamin D levels.