Re: The Marshall Protocol exposed (again)

[Guest guest]

Well- That's pretty thorough. He just have a LIST of people he wants to sue..

I guess he's still out there beating the bushes for people to subscribe to his

theories.

Barb

--- In infections , Penny Houle <pennyhoule@...>

wrote:

>

> Someone sent me a link to the following post from the Pro Health site:

>  

> http://www.prohealth.com/me-cfs/blog/boardDetail.cfm?id=1354223 & B1=EG070109

>  

> mayers

> 6/16/09 7:36 PM

>  

> Hidden Risks and Dangers of the Marshall Protocol

>  

> “The human body does not require sunlight, nor foods containing Vitamin D,

in order for it to function correctly. The human body can manufacture all the

Vitamin D it needs from its own 7-dehydrocholesterol. Clinical medicine is just

plain wrong on its understanding of the actions of Vitamin D.†Trevor Marshall

(1)

>

> The Marshall Protocol (MP) claims to cure CFS and FM, as as such, is a very

polarizing topic. People are either really for it, or really against it. Seduced

by the molecular modeling and hope of a cure, I was on the protocol for almost

two years. However, after almost landing in ER and experiencing a permanent

deterioration in all my CFS symptoms, I have learnt first-hand of the dangers

and risks of the MP, none of which I was warned. The MP worsened my existing CFS

symptoms such as fatigue, sleep dysfunction, muscle and joint pain and created

new symptoms such as neuropathy, parenthesisa, breathing difficulties, cardiac

pain and tinnitus which have persisted. Thus I feel that it is my duty to warn

others who may be considering the MP, which continues to attract many new

patients, of all the hidden risks so that they can make a fully informed

decision about whether to undertake this protocol.

>

> The Marshall Protocol claims to be a curative treatment for illnesses caused

by cell wall deficient bacteria. Given that various credible researchers such as

Nicholson and De Meirleir have found mycoplasma in between 50-68% of CFS and FM

patients, the MP seems to be a logical treatment option (2). (However it is

unclear whether mycoplasma are the causative agent for CFS or FM or a secondary

infection.) However, just because mycoplasma may be involved in your condition,

it does not necessarily follow that the Marshall Protocol is either a safe or

effective therapy.

>

> Invented by electrical engineer Trevor Marshall PhD, the Marshall Protocol was

initially designed for the treatment of sarcoidosis, a Th1 disease in which

granulomas form in the lungs and where vitamin D pathways appear to be

deregulated (this is generally not the case with CFS). The treatment is based on

the premise that 25 vitamin D is immunosuppressive, that the cell wall deficient

bacteria are converting excessive amounts of it into 1,25 vitamin D which

creates inflammation in the body and thus disease symptoms. Consequently the

Marshall Protocol advocates:

>

> 1 Eliminating exogenous sources of vitamin D including both dietary and

sunshine. (This is includes blocking windows and installing low watt globes).

> 2 The use of Benicar in high doses which partially blocks the vitamin D

receptor and inhibits certain inflammatory processes.

> 3 The use of different combinations of low pulsed antibiotics in order to

eliminate the bacteria. (Penny's note: I would add here that the minocyline

literature cites dangerous side effects that the MP dismiss as " herx " .)

>

> The elimination of vitamin D in tandem with the use of Benicar is claimed to

switch on the innate immune system so that it ‘sees’ the bacteria. Marshall

claims that the antibiotics don't directly kill the bacteria, but merely latch

on to their RNA subunits, weakening them, and allowing the immune system to

eliminate them. This theory, none of the elements of which have ever been tested

in a lab, has since been rolled out to all autoimmune diseases as well as CFS

and FM all of which Marshall claims are Th1 conditions and thus have the same

pathogenesis and can all be cure by his protocol.

>

> Who is Trevor Marshall?

> Before I tackle the safety of the MP directly I think there is value in having

a look at who Trevor Marshall is as the protocol has been wholly created by him

and is not endorsed by any other researcher. While there has been some interest

in his theories lately, there is little support in the biomedical or molecular

modeling communities for the protocol to be applied to patients in its present

form.

>

> Trevor Marshall trained as an electrical engineer and did his PhD thesis with

the Department of Electrical Engineering on modeling insulin production and

flows in diabetic patients (using mathematical equations). Although he spent

some time in the early 1980s modeling reproductive hormones, he spent most of

his career working on electronic engineering and IT, including running YARC, a

printer technology company, from 1988 until its bankruptcy in 2000. During this

time YARC, headed by Marshall, was involved in over a dozen litigations at the

Superior Court of California, predominantly as the defendant. The most

interesting being ph La Bruna v. YARC Systems Corporation (2001) where the

court found that Marshall “made representations and promises and concealed and

omitted the true facts knowing such representations, promises and concealments

and omissions to be false. They were made with the intention of deceiving,

defrauding and misleading the

> plaintiff, and to induce him to act in reliance thereon.†(3)

>

> After YARC went bankrupt, Marshall devoted himself to reading as much as he

could on sarcoidosis, from which he suffered, and devised the Marshall Protocol

in order to rid himself of the disease. After he and a small group of other

sarcoidosis patients began noting improvements in their condition, Trevor

Marshall decided to create a study site on the web for other sarcoidosis

patients in 2002 and then in 2004 decided that all autoimmune illnesses, as well

as CFS and FM, were Th1 illness and had the same pathogenesis as sarcoidosis and

opened the study site up to all these conditions.

>

> It is important to note that Trevor Marshall has little research experience in

chronic illnesses and no formal training or research experience in microbiology,

biochemistry or drug administration. While Trevor Marshall promotes himself as a

Biochemical Engineer his PhD was in electrical engineering and consists of many

equations modeling the effects of insulin in diabetic patients. His area of

expertise is computer modeling, rather than medicine. His understanding of

immunology is based on his own readings of various scientific literature.

>

> How was the Marshall Protocol devised?

> Trevor Marshall devised the protocol in order to treat his own sarcoidosis. He

read into the discipline as an outsider and created a theory from his own

research and personal experiences. He then wrote a computer model based on his

research. The current Marshall Protocol is an extrapolation of the sarcoidosis

theory to all autoimmune conditions which Marshall claims are all Th1 illness.

(CFS is not considered an autoimmune condition and is considered a Th2 dominate

illness not Th1 dominant illness). No objective lab work or animal testing was

performed in order to determine the safety or efficacy of the treatment. Trevor

and a few compatriots who were sarcoidosis patients simply experimented with

various drugs on themselves. While Marshall has presented his model at a number

of conferences now, he has not published any scientific papers on the full

protocol itself in any peer reviewed journals. There is no support for his work

in the biomedical community

> as he has not presented any objective data to support his claims.

>

> Is it a cure?

> The protocol is promoted as a curative treatment yet there is no evidence of

this yet. The statement is made based solely on Marshall’s theoretical model

not patient outcomes. After 5 years, no CFS patients are permanently of all the

medications (including Benicar) and completely ‘cured’. While some patients

have improved on the antibiotics, many of them have relapsed when they have

stopped taking them and many still have just steadily deteriorated. A couple of

CFS patients who had improved on the protocol and were held up as 'success

stories' relapsed after stopping the antibiotics after 3-4 years on the

protocol. Other patients stopping the protocol have also developed urinary tract

infections, cancer and osteoporosis after extended periods on the MP. If you

read the Phase 2 and 3 web boards on the www.marshallprotocol.com (you need to

be a member in phase 2 or 3 to have access to these) you will see that the

health of many people deteriorated

> while on the MP and they have had difficulty clawing it back (4). You will

not hear about this or any such dangers on the public access Marshall Protocol

site or www.curemyth1.org or www.bacteriality.com. There only the success

stories are advertised.

>

> The time promised for full remission on the Marshall Protocol was initially

12-18 months, then it became 2-3 years, then 3-5 years now 8-10 years is being

bandied about. These are all Marshall’s projections, none of these claims are

based on fact or outcomes. That’s an awfully long time to be on antibiotics

and out of the sun.

>

> Hidden Risks

> Marshall claims that his protocol is perfectly safe for use by adults and

children but does not provide any evidence to back this claim up. In fact the

protocol involves many risks none of which are disclosed on the Marshall

Protocol site, namely:

>

> 1. The risk of being out of the sun for extended periods of time will

invariably deregulate your hormones. Vitamin D is a hormone that is critical to

numerous of functions in the body. Long term vitamin D deprivation is associated

with an increased the risk of osteoporosis, rickets and cancer. Vitamin D plays

an important role in both the adaptive and innate the immune systems and has

been found to be responsible for the synthesis of antimicrobial peptides(5).

Marshall thinks that clinical medicine is completely wrong, that vitamin D is

always immunosuppressive and dismisses the health risks associated with vitamin

D deprivation because they do not fit in with his theories.

>

> 2. Modulating the immune system for prolonged periods in a way that has not

been tested in a lab or on animals can have all sorts of dangers. Marshall has

based his protocol on a computer simulation which is underpinned by his

assumptions, rather than lab tests. Medical science does not yet fully

understand what various receptors and components in the immune system do and

what happens if you shut some of them down. For example, if you block

Angiotensin II Receptor, which Benicar does, wound healing is impaired. Any

number of feedbacks or alternative pathways could result none of which are known

or can be predicted in a computer model. We simply don’t have enough

information to make definitive claims yet.

>

> 3. The risk of taking antibiotics over long periods of time can create

resistant strains of bacteria. This is especially a risk where patients are

exposed to concentrations of antibiotics which are below the minimum

concentration required for killing bacteria as on the Marshall Protocol.

Bacteria have a number of ways in which to avoid being detected or killed by

antibiotics particularly when they are exposed to them over a long period of

time. Indeed resistance to macrolides (which are used in the MP) is an

increasingly growing problem.(6) Marshall claims that it is the immune system,

not the antibiotics doing the killing, that the antibiotics simply weaken the

bacteria and make them more susceptible to being killed by the immune system,

but there is no evidence of this. You just have to trust his theory that vitamin

D is always immunosuppressive (which no one else agrees with) and its absence

activates the immune system. One must also consider damage

> that long term impacts of antibiotic use can have on bacteria in the

gastrointestinal tract.

>

> 4. Side effects of the drugs themselves:

> o Benicar: The Marshall Protocol recommends the use of Benicar at four times

the recommended dose for extended periods.

> - Benicar is a very effective antihypertensive agent and also decreases

aldosterone levels. CFS specialist Dr. Cheney states that this can be

problematic in CFS patients who already often have low blood volume and low

aldosterone levels.

> - The safety of Benicar has only been tested on humans for up to a year and

only at half of the dose recommended by the Marshall Protocol. It has only been

tested on rats for up to 2 years, yet the protocol requires patients to remain

on Benicar for several years. (7)

> o The antibiotic Minocycline can have a number of side effects especially when

used over the long term. Many of these are similar to the rise in symptoms that

patients are told to expect from bacterial die back(8). So it is impossible to

tell whether patients on the MP are experiencing bacteria die back or just a

drug side effect.

> o Other antibiotics used in the MP are not typically used over the long term

so little is known about their safety over extended periods.

>

> Patient Care

> Every symptom encountered on the site is attributed by the moderators to

toxins released due to bacterial die back or 'Jarisch Herxheimer Reaction' (or

'herx'). Symptoms can be acute and varied and can include cardiac symptoms,

breathing difficulties, vomiting, depression etc…Some of these may be

dangerous drug reactions others merely exacerbation of disease symptoms.

Moderators constantly assure patients on the internet web boards that these

symptoms are an indication of bacterial die back, that their medication dosage

should merely be adjusted and at best some palliation may be required. No other

alternative causes such as allergic reactions, drug toxicity, disease

exacerbation, vitamin D deficiency are ever suggested as these symptoms are

never contemplated as possibilities on the MP, despite the fact that vitamin D

deficiency is known to create depression, muscle and joint pain (9). Patients on

the MP are encouraged to drive their 25 vitamin D

> levels to below 12ng/ml on Phase 2 and 3 of the protocol, which is severely

deficient, the recommended vitamin D levels being 32-65ng/ml.

>

> Interestingly the moderators who are advising patients on how to interpret

symptoms and how to adjust their medication are all themselves Marshall Protocol

patients. They have all yet to finished the protocol and are still ill (to

varying degrees) and see the protocol as their only way out of the disease. They

all cling to the protocol as it represents hope, the only road to health and

gives them a sense of control over their illness. As such, they are all very

devoted to the protocol which inevitably clouds their judgment when advising

patients on how to interpret symptoms and adjust their medications or whether

the patients ought to be on the protocol at all. The overriding goal of the MP

site is not to achieve the best possible outcome for the patient, but to push

the patient through the protocol, as it is automatically assumed that in the end

this will be in the patient’s best interest. Thus patients are encouraged to

‘hang in there’ even when

> their symptoms are quite acute and dangerous and are assured that this is a

sign of bacterial die back and thus part of the healing process. This has

resulted in a number of patients ending up in emergency wards.

>

> Validity of Data

> While the Marshall Protocol site claims to be a study site, the evidence used

to support the MP on the site is not objective. Any positive post by a patient

on the Marshall Protocol.com site is put up in the success stories section even

though the improvement may be temporary and the patient has subsequently felt

worse. The only way to verify this is to read all of a patients posts in the

Phase 2/3 forum which are off limits to anyone not in phase 2 or 3. A handful of

people have improved on the MP but it is a much smaller number than the success

stories page would have you believe and improvement is based on self reporting.

There is no way of knowing what percentage of people who started the MP have

subsequently improved because anyone who stops the MP, due to an adverse

reaction to the protocol is discounted. No one is interested in why they dropped

out and none of this is followed up or documented. One only needs to scan the

membership list (which has

> date of commencement and number and date of patient posts) to see how high

the dropout rate is. These patients are simply dismissed as not being tough or

dedicated enough, or not complying with the rules. Only those who stay on it for

over a year are eligible for inclusion in any ‘study’. So far the only study

conducted was a voluntary retrospective survey that was sent out to a random

selection of patients. Obviously those having more success with the protocol are

more likely to stay on it as well as respond to a survey. The patient feedback

was retrospective and based on self reporting so this study (which was conducted

by a patient as well) has more holes in it than Swiss cheese. This is the data

that Marshall cites at conferences in order to prove the efficacy of the MP.

>

> Interestingly no one is off all the MP medications and actually cured

themselves of anything except perhaps Trevor Marshall. The number of CFS

patients who have not relapsed going off the antibiotics is still in single

digits. Most patients are plugging away on 3 different types of antibiotics,

Benicar often with anti-inflammatories, pain killers, sleep meds etc…and

claiming they feel better or that they will 'turn the corner soon'. It is

difficult to know what is a drug effect and what is genuine improvement as

Benicar and Minocycline do have an anti-inflammatory effect which could be

mistake for genuine healing and, as state previously, most MP patients have

experienced a worsening of symptoms when discontinuing the antibiotics which is

ongoing (see patient comments on the following web boards) (10). This all

implies that at best the antibiotics were palliating their symptoms and at worse

suppressing their own immune systems allowing bacteria to

> proliferate and possibly breeding new antibiotic resistant strains of

bacteria on the way.

>

> Patients often persist on the Marshall Protocol despite being in great pain as

cling to the hope of a cure and they are told by moderators that these symptom

exacerbations are a sign of healing. Thus often patients do not quit until their

symptoms become so intolerable that they are forced to stop. Interestingly, of

the 40 MP the patients at my doctor’s clinic who persisted into Phase 2 (most

dropped out in phase 1 due to acute symptoms), half them have experienced a

worsening of CFS symptoms as a result of the MP and they have often developed

new CFS symptoms including orthostatic intolerance, anxiety, neuropathy, muscle

and joint pain, light sensitivity, digestive problems and depression. The other

half managed to return to their pre-MP level of health after a couple of months

(these people usually have spent less time in Phase 2.) Interestingly, none of

the ex-MP patients from my clinic have experienced any symptoms improvement

after stopping the

> MP. One would think that if bacteria were indeed being killed by the

protocol, that at least someone would feel better after all that herxing.

>

> Conclusion

> Perhaps the biggest folly of the Marshall Protocol is the belief that what

happens in a computer simulation will be directly replicated in the human body.

The human body is vastly complex system with multiple pathways and feedback

loops. The idea of calculating the drug affinity of a few receptors on a

computer, running a simulation, and then confidently claiming that this will be

replicated in the human body is naïve and dangerous. Molecular modeling is a

starting point for research, it provides a general direction for lab work,

avoiding the needle in the haystack approach to research which wastes time. But

all of this needs to be validated step by step in the lab before being rolled

out to desperate patients as cure, especially when it contradicts many current

lab findings, as the Marshall Protocol does. Patients on the MP are expected to

trust the results of one computer model, however unfortunately theory does not

neatly translate into reality (11).

> We don’t know enough about how bacteria and the immune system work to build

reliable models at this stage.

>

> So in summary the risks of going on the Marshall Protocol include:

> - Risks associated with having low vitamin D for extended periods of time

include immune suppression, risk of cancer, rickets and osteoporosis.

> - Risk of modulating the immune system in untested ways with unknown

consequences.

> - Risk of taking Benicar at four times the recommended doses for prolonged

periods of time with unknown consequences.

> - Risk of developing bacterial resistance and proliferation from being on

antibiotics for long periods of time and a worsening of your condition.

>

> These are substantial health risks to be taking in light of the lack of

evidence to support the claim of a cure for CFS and FM by the Marshall Protocol.

So if mycoplasma are found to be contributing to your condition, it may be best

to consider other treatment options.

>

> Footnotes:

> (1): http://www.marshallprotocol.com/view_topic.php?id=9023 & forum_id=35

jump_to=178280#p178280

> (2): http://www.immed.org/illness/fatigue_illness_research.html,

http://www.neurotransmitter.net/mycoplasma.html

>

> (3) JOSEPH LA BRUNA VS YARC SYSTEMS CORP, Superior Court of California, County

of Ventura (2001) Case number: CIV201956 ; A summary of this and other cases can

be read at

http://www.sarkoidose.de/apboard/useraction.php?action=get_upload & id=23; The

list of court cases the YARC and Marshall were involved in can be found by

typing ‘YARC’ into the Case Enquiry search box (for Civil cases) at the

Superior Court of California, County of Ventura website found at:

http://www.ventura.courts.ca.gov/vent_frameset_puba.htm

> (4) See the patient comments on the following pages:

http://heartscanblog.blogspot.com/2008/03/marshall-protocol-and-other-fairy-tale\

s.html,http://articles.mercola.com/sites/articles/archive/2009/03/14/Clearing-Up\

-Confusion-on-Vitamin-D--Why-I-Dont-Recommend-the-Marshall-Protocol.aspx

>

> (5)

http://www.jimmunol.org/cgi/content/abstract/179/4/2060?maxtoshow= & HITS=10 & hits=\

10 & RESULTFORMAT= & searchid=1 & FIRSTINDEX=0 & minscore=5000 & resourcetype=HWCIT,

http://www.sciencemag.org/cgi/content/abstract/1123933v1,

http://www.ncbi.nlm.nih.gov/pubmed/19285323?ordinalpos=6 & itool=EntrezSystem2.PEn\

trez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum,

http://www.ncbi.nlm.nih.gov/pubmed/19086827?ordinalpos=17 & itool=EntrezSystem2.PE\

ntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum,

http://www.ncbi.nlm.nih.gov/pubmed/19090451?ordinalpos=15 & itool=EntrezSystem2.PE\

ntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum,

http://healthnewsdigest.com/news/Patient_230/Vitamin_D_Immune_Response_May_Reduc\

e_Fatal_Infections_in_Dialysis_Patients.shtml

>

> (6) http://aac.asm.org/cgi/content/abstract/50/11/3646,

http://www.ncbi.nlm.nih.gov/pubmed/14733843,

http://www.docguide.com/news/content.nsf/news/8525697700573E1885256AE800496803

> (7) http://www.fda.gov/medwatch/SAFETY/2004/nov_PI/Benicar_Tab_PI.pdf

> (8) http://www.drugs.com/minocycline.html,

http://www.drugs.com/pro/minocycline.html

> (9)

http://www.webmd.com/pain-management/news/20031210/lack-of-vitamin-d-linked-to-p\

ain,

http://www.nutraingredients-usa.com/Research/Vitamin-D-deficiency-linked-to-grea\

ter-pain

>

> (10) See the patient comments on the following pages:

http://heartscanblog.blogspot.com/2008/03/marshall-protocol-and-other-fairy-tale\

s.html,http://articles.mercola.com/sites/articles/archive/2009/03/14/Clearing-Up\

-Confusion-on-Vitamin-D--Why-I-Dont-Recommend-the-Marshall-Protocol.aspx

>

> (11) http://www.thisisms.com/ftopic-5628-0-days0-orderasc-.html,

> http://stuff.mit.edu/people/london/universe.htm

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