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The Marshall Protocol Study Site > PROF. MARSHALL'S PERSPECTIVE > Prof. Marshall's Perspective > Web Conference Announcements [pacific daylight time]


Web Conference Announcements [pacific daylight time]
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Prof Trevor Marshall
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 Posted: Thu Feb 17th, 2011 17:28

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This week I will be taking a closer look at the former FDA commissioner's "Science of Safety" concept, and explaining why it is important to understand exactly how drugs work, before you take them :)

I want to also show the video on mosquitos which I didn't ge to last week, I will try and answer more of the questions being sent to me.
 
..Trevor..
 
http://marshallprotocol.com/conferences/

Leo
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 Posted: Sat Feb 19th, 2011 14:06

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Hi, could someone please point me to the study TM mentioned in todays'  web conference regarding effects of UV light on human biochemistry ? (UV light not inducing the production of a whole lot of D, but of endorphins, cytokines etc) ? Thank you.

Joyful
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 Posted: Sat Feb 19th, 2011 14:23

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I would like to see that paper link also Leo. :)

Note: the recording is already posted from todays videoconference:

http://marshallprotocol.com/conferences/

Last edited on Sat Feb 19th, 2011 14:25 by Joyful



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titta
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 Posted: Sat Feb 19th, 2011 14:33

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I am really glad that the conferences are recorded.
For me the video stopped all the time and the audio just vanished.
So I have the chance to watch it when the internet pleases to let me.

Thank you for your efforts!

Titta



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Prof Trevor Marshall
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 Posted: Sat Feb 19th, 2011 14:37

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Fulltext is at:

http://www.pnas.org/cgi/pmidlookup?view=long&pmid=20308557

..Trevor..

Leo
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 Posted: Sat Feb 19th, 2011 17:35

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Hi, thanks for the link, but I cannot find anything in there about UV-induced biochem. pathways. It does show little D-production upon UVB exposure and talks about immunosuppressive effects, but there is no mention of cytokine (etc) - production neither in this text nor in any of the reference-abstracts (21, 32) ?? Thanks.

Prof Trevor Marshall
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 Posted: Sat Feb 19th, 2011 19:40

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UVB is likely suppressing disease through mechanisms that are independent of vitamin D production.
UVR can suppress the immune system through a number of mechanisms independent of vitamin D, including inhibiting antigen presentation, altering inflammatory cytokine levels, and inducing suppressor T-cell populations (32). Therefore, we suggest that UVR is likely playing a role in immunosuppression independent of vitamin D production

It is important to realize that this team was led by Hector DeLuca, the inventor (patent holder) for 1,25-D -- and the whole tome therefore downplays their primary result - that 25-D was not induced in the skin in the amounts they had expected.  Understatement and caveats abound in this paper. However, it is one of the very few studies which have dared to test current dogma, and found that dogma wanting :)
 
 

Joyful
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 Posted: Sun Feb 20th, 2011 14:45

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On parasites, Th1 v. Th2 immune response:

Phillyguy wrote:
Journal of neuroimmunology. 2011
The impact of parasite infections on the course of multiple sclerosis.
Correale J, Farez MF

Previously, we demonstrated that helminth-infected MS patients showed significantly lower number of relapses, reduced disability scores, and lower MRI activity compared to uninfected MS subjects. In the current study, 12 patients with diagnosis of relapsing remitting MS presenting parasite infections were prospectively followed during 90months; due to exacerbation of helminth-infection symptoms after 63months of follow-up, 4 patients received anti-parasite treatment. Helminth-infection control was associated with significant increase in clinical and radiological MS activities. Moreover, these patients showed significant increase in the number of IFN-γ and IL-12 producing cells, and a fall in the number of TGF-β and IL-10 secreting cells, as well as CD4+CD25+FoxP3+ Treg cells evident 3months after anti-helminth treatment began. These new observations on parasite infections associated to MS indicate that parasite regulation of host immunity can alter the course of MS.


Probably explains one of the reasons why the incidence of autoimmune disease is lower in developing countries and infectious disease is higher. Interestingly, VDR generally increases the expression ofTregs, IL-10 and TGFbeta and represses IFNg and IL-12.


Phillyguy wrote:
Regulatory T cells, IL-10 and TGFb are generally considered to be anti-inflammatory or immuno-suppressive, depending upon how you view them. I doubt that helminths increase this cell type and these cytokines in a VDR dependent manner. So you might get the anti-inflammatory effects without the antimicrobial peptides, etc.

The parasites bias the immune system toward a TH2 dominant state, which is generally tolerant of bacteria and viruses. I suspect that these patients accumulate a larger microbiota while on helmenthic treatment and are worse off when they are eradicated.

Eradication of helminth infections have been associated with a reduction in HIV viral copy count and incidence of tuberculosis in developing countries.

The hygenists will make the claim that this is evidence that we evolved with parasite infections and that they are required to dampen autoimmune reactions. However, helminths can cause all kinds of problems and can even escape the intestinal tract and end up in other parts of the body.

I think its best to keep the bacteria and viruses down rather than distract the immune system with worms.

I might find the hygenic theory persuasive if we didn't live in a global community and weren't continually exposed to foreign bacteria and viral species.

One man's probiotic is another man's pathogen. Just ask the Mayans and Native Americans when the spanish first came to the Americas.....


From this thread:
http://marshallprotocol.com/view_topic.php?id=13716&forum_id=43&jump_to=206857#p206857



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Sunset
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 Posted: Tue Apr 12th, 2011 15:48

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Not sure where to post these questions and thoughts for discussion, perhaps at our next web conference these could be topics for discussion? :)


1) The Silent Saboteurs, by Dr. William Nordquist, DMD MS & Dr. David Krutchkoff, DDS MS

I haven’t heard any discussion on this site about this book about chronic disease that references Trevor Marshall’s research on the immune system and Vit D yet. But since Dr. Marshall did speak briefly about it during one of our Saturday web conferences and I have picked up a copy of it to read, I figure it is fair game for discussion here now. :)

The authors suggest that a particular group of bacteria in the mouth, Spirochaetes, may be among the organisms that lay the framework for chronic inflammation and disease in remote areas of the body. I’m through chapter 6 of this book now and I’m wondering if the authors have a plausible theory of how chronic disease establishes itself in the body or is their hypothesis too narrow in its scope?

2) I also have a question about olmesartan medoxomil and its conversion to the active form olmesartan within the body. I may be way off-base here, but is it possible that people who are poor metabolizer's in general and/ or an individual whose body (ie/ gut flora changes or severe GI disease) has changed overtime during recovery on the MP may no longer convert the inactive to the active (pure olmesartan) form in a consistent way thus leading to unstable or higher levels of IP? And if so, is taking larger and or more frequent doses of olmesartan medoxomil regularly how we overcome this issue?

Looking forward to the next web conference on April 16th!

Best reagards,
Sunset :)

"The greatest obstacle to knowledge is not ignorance, it is the illusion of knowledge" ~ Daniel Boorstin

Last edited on Tue Apr 12th, 2011 17:55 by Sunset



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Prof Trevor Marshall
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 Posted: Wed Apr 13th, 2011 00:54

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Answer 1. The field of metagenomics is only 4 years old. People who have not been following the explosive progress in this field tend to think in terms of Koch's Postulates, and 19th century concepts :X

Answer 2. Here is part of what our FDA IND application says, Sunset:

"Olmesartan is the active moiety in the blood and tissue which follows ingestion of the prodrug ester, Olmesartan Medoxomil (OM).

The  Medoxomil ester is stripped from the active Olmesartan moiety by carboxymethylenebutenolidase (CMBL), a homolog of Pseudomonas dienelactone hydrolase[1] .

The medoxomil prodrug was designed specifically to slow absorption, in expectation of a q24h or q12h dosing regime for the intended hypotensive indication. It is not absorbed from the stomach, as there are no suitable CMBL enzymes in the healthy stomach.

Additionally, .. the time to peak plasma concentration from ingestion of Olmesartan Medoxomil is typically 1.5 hours on an empty stomach, but it may slow to 4.5 hours after a meal, a delay exceeding the q4h dosing cycle.

This unpredictable absorption profile makes it extremely difficult for
(a)    severely ill patients to control high levels of unexpected Immunopathology, and
(b)    severely ill patients to adjust a q4h or q6h dosing interval to match their food intake and GI tract disease-status

Pure Olmesartan seems to be absorbed more quickly than the prodrug, reaching peak concentrations in less than one hour .. This absorption does not seem to be significantly affected by food, as Pure Olmesartan requires no esterase activity in order to reach the bloodstream."


1. Ishizuka T, Fujimori I, Kato M, Noji-Sakikawa C, Saito M, Yoshigae Y, Kubota K, Kurihara A, Izumi T, Ikeda T, Okazaki O: Human carboxymethylenebutenolidase as a bioactivating hydrolase of olmesartan medoxomil in liver and intestine. J Biol Chem. 2010 Apr 16;285(16):11892-902.

Sunset
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 Posted: Wed Apr 13th, 2011 16:29

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Dr. Marshall wrote:

Answer 2. Here is part of what our FDA IND application says, Sunset:

"Olmesartan is the active moiety in the blood and tissue which follows ingestion of the prodrug ester, Olmesartan Medoxomil (OM).

The Medoxomil ester is stripped from the active Olmesartan moiety by carboxymethylenebutenolidase (CMBL), a homolog of Pseudomonas dienelactone hydrolase[1] .

The medoxomil prodrug was designed specifically to slow absorption, in expectation of a q24h or q12h dosing regime for the intended hypotensive indication. It is not absorbed from the stomach, as there are no suitable CMBL enzymes in the healthy stomach.

Additionally, .. the time to peak plasma concentration from ingestion of Olmesartan Medoxomil is typically 1.5 hours on an empty stomach, but it may slow to 4.5 hours after a meal, a delay exceeding the q4h dosing cycle.

This unpredictable absorption profile makes it extremely difficult for
(a) severely ill patients to control high levels of unexpected Immunopathology, and
(b) severely ill patients to adjust a q4h or q6h dosing interval to match their food intake and GI tract disease-status

Pure Olmesartan seems to be absorbed more quickly than the prodrug, reaching peak concentrations in less than one hour .. This absorption does not seem to be significantly affected by food, as Pure Olmesartan requires no esterase activity in order to reach the bloodstream."


From a patient compliance stance I understand totally why Sankyo would prefer to market the prodrug OM for the HTN indication since it only needs to be taken once a day vs. multiple times daily.

But given that the only drug option we currently have at our disposal at this time is the olmesartan medoxomil (OM) compound, am I correct in thinking that administration of OM on an empty stomach could help reduce IP instability issues for those individuals with liver and/or intestinal disease conditions? Is there any chance for harm to individuals in the cohort due to lack of effective control of IP if conversion of OM to PO does not occur in a consistent and predictable manner?

I have a lot of GI health issues so this may influence whether or not I believe it is safe and effective to continue taking OM vs. waiting for PO to be approved by the FDA for treatment of Th1 illness.

Also, what if anything is known about the SL route of delivery which appears to help sometimes (this is suggested from anecdotal evidence among this site's cohort group) with achieving a rapid drug effect when OM is administered this way when excessive IP occurs?

Thanks in advance for your thoughts.

Best regards,
Sunset :)

"The greatest obstacle to knowledge is not ignorance, it is the illusion of knowledge" ~ Daniel Boorstin

Primum non nocere

Last edited on Wed Apr 13th, 2011 16:31 by Sunset



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 Posted: Wed Apr 13th, 2011 21:38

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Sunset, What is known about S/L dosing? Well, it seems to work, but primarily on the brain. IMO you still need the oral drug to deal with systemic issues. Colleagues researching PO have largely stopped using S/L, it is no longer necessary as the PO p.o. dosing is reported as 'more reliable' (don't ya luv abbreviations :) )

Don't delay until pure olmesartan is freely available. We are limited by what speed FDA moves at. You will have it available when you need it most - for speeding the final stages of healing. I know no evidence suggesting that OM might damage your gut more than PO.

OM and PO can be interchanged dose-to-dose. They don't seem to interfere. Further, if PO is thought to be producing too much IP, then OM can be swapped back in without a weaning interval.

The Phase 1 study we have proposed to the FDA is a straight dose-for-dose substitution in seriously-ill members who are currently taking OM. The primary end-point is assessment that the dose we are using (25mg of PO) is adjudged  'therapeutically equivalent' to 40mg of OM in Th1 disease. Not sure if the FDA will 'buy' this, but we will keep plugging away..

 
Note to FDA-types reading this: The above info is written in answer to questions from a Health Professional, and is not intended to be read as substantiated claims or warranties of performance. Readers are warned to not believe anything printed here...

tammy1000
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 Posted: Thu Apr 14th, 2011 04:28

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Sunset,

I have celiac disease, extensive food allergies, food intolerances, and digestive limitations. I eat mainly soft, well-cooked, bland foods. I have been clinically underweight for most of the last 20 years.

I also wondered if I would assimulate the pure Olmesartan better, but I do know that I am able to assimulate a good percentage of Olmesartan from the OM. I don't know whether this is good or bad -- but unlike most people -- I have a herx reaction almost every time I take the olmesartan. (It is not palliative for me.) The "severity" of the herx depends on how I take it, and whether I have taken antibiotic, etc. My worst reaction occurs during the dose that I take about 6 hours after the abx (which is also on an empty stomach at 12:30 am).

I take compounded olmesartan at 6:30, 12:30, 6:30, and 12:30 -- three times a day with meals, then I take the midnight dose on an empty stomach.

Taking the olmesartan at 3, 9, 3, and 9 -- on an empty stomach -- creates stronger IP responses, but it also irrititates my sensitive GI. I have to be careful because too much GI irritation and I get intolerant to the medication.

I don't know if the pure Olm w/out the medoximil would be more or less irritating to the GI, or have about the same level of tolerability.

TO MP board: Please advise if future posts should instead be sent as PMs.

Regards, Tammy

 

 



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Prof Trevor Marshall
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 Posted: Thu Apr 14th, 2011 05:03

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Please advise if future posts should instead be sent as PMs
There are many members who might be helped by observing discussions who would not get the PM's. It is always best to post questions in open forum.

..Trevor..
 

ChrisMavo
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 Posted: Thu Apr 14th, 2011 13:21

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Dr Marshall, given my neurological illness (ALS) I wonder if I should take more SL dosages of OM.  I have done this intermittently .. but not on a regular basis. 

Probably wishful thinking, but, I sure hope the FDA moves rapidly so we can get the PO study underway soon!



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Joyful
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 Posted: Fri Apr 22nd, 2011 11:46

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Chris, I think Cynthia has reported that a quarter of a tablet sublingual has been helpful for her with various symptoms. What's good about that is you get 4 doses out of a single tablet. :)



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ChrisMavo
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 Posted: Fri Apr 22nd, 2011 11:56

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Thanks Joyful!  I have been trying to use 20mg sublingual doses of Benicar since last Saturday's webconference.  So far I have not really noticed much difference.



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Joyful
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 Posted: Fri Apr 22nd, 2011 12:35

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Some use a little chunk of dark chocolate at the same time. Maybe to stimulate salivary output while trying might help some?

Sublingual has always made a quick difference for me, so maybe there are individual differences that affect it's impact.

Also, if you are using tea/coffee or otherwise getting a lot of CGA, perhaps it is blocking the olmesartan's ability to dock into the VDR or other receptors. I believe it was Marysue that pointed out that she had that problem a few months back.



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ChrisMavo
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 Posted: Fri Apr 22nd, 2011 12:44

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I have some dark chocolate every night.. and I also drink two cups of coffee a day... one when I get up ... and one in the evening.  Hate to think I have to give up the coffee!! 



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Prof Trevor Marshall
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 Posted: Fri Apr 22nd, 2011 12:56

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ChrisMavo wrote: Hate to think I have to give up the coffee!!
Try Hot Chocolate instead. You can produce your own mix with Droste Cocao and D-free Powdered milk. A tablespoon in hot water (60 degrees C) add stevia (or whatever) to taste, and you will have a good, safe substitute.

Coffee has no effect on me any more, if it has an effect on you, that is probably not a good thing :X :X
 


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