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Article: Dr. Mikovits Talks! The XMRV Santa Rosa Lecture: Part II by Lannie

Some researchers pointed out a similar issue showed up in the Science paper where it appeared that the WPI retested people with CFS in their attempt to find the virus but did not retest the healthy control samples. They assumed a negative control was a negative control but a negative patient might be a postiive - so they retested some patients several times - thus trying harder to find the virus in them.

Cort, do we know for sure that WPI did in fact test the CFS samples multiple times but NOT the healthy controls? If this is a confirmed fact, it is a really big pitfall. Remember that one of the contamination theories attempting to explain the disparity between CFS and control samples is that the CFS samples were handled more than the controls. If the CFS samples were in fact handled more, that gives a toehold to the contamination theories (but does not prove it, obviously).

The WPI has been very confident in their results.

Jonathan Stoye is confident in his results too. I love seeing confidence in CFS researchers, but it's not evidence one way or the other. Data data data!
 
i have to say though i do find these treatment 'options' a tad disappointing. we have known all this information about glutathione and the methylation cycle for quite some time now and although when i took folinic acid, liposomal reduced glutathione and methylcobalamin (I/M) for around 6 months i felt an improvement in cardiac symptoms, most probably due to reduce homocysteine? i still did not see much of a change in energy physical or mental. i mean how long does one need to go on the methylation cycle treatment to see a marked change in this disease process and is dr. mikovits saying adding in ARV's with the meth. cycle components will enhance efficacy?

i am shocked tbh because i cannot see taking all those supplements again really doing much. I am on ARVS right now (Tenofovir and AZT) that has done nothing for my symptoms, so are they suggesting a much more powerful synergistic effect when these two components are combined??

Please some one explain i am so confussssssed :S

Hi, energyoverload.

I'm sorry to hear that the methylation treatment you tried did not bring you more benefit. Perhaps using Metafolin (methylfolate) rather than folinic acid would be more helpful. It is available in the UK. Some people have difficulty converting folinic acid into methylfolate for genetic reasons. Other issues that can limit the effectiveness of methylation treatment are deficiencies in amino acids which are needed to feed the methylation cycle and related pathways, and deficiencies in the vitamin and/or mineral cofactors for this part of the metabolism. HPU/KPU is another possibility, since it depletes B6, zinc, manganese, biotin and other nutrients. Also, people who have Lyme disease or mold illness appear to need separate treatments for these in addition to the methylation treatment.

I was not present at Dr. Mikovits's talk, so I don't know exactly what she said, but my impression from the reports as well as from speaking with her a couple of times in the past is that she is suggesting that combining treatments may help. I don't think there is much experience with this yet. I think she is projecting from the genetics and biochemistry, as I am also trying to do.

I'm sorry that all of this has not yet been worked out and tested. All we can do is to start from where we are. I know it's frustrating.

Best regards,

Rich
 
Hi, Cort.

Yes, I am very happy to see these things coming together! As I have been posting lately, it makes a lot of sense from biochemical and genetic standpoints that oxidative stress, glutathione depletion, and a methylation deficit would be connected with the retroviruses. Some sort of combined treatment does seem to make sense to me, too.
I would like to thank you Rich for all of your research and support.

I would consider myself re-methylated (ha, yes, I am making up words!), and I can't thank you enough.

As I go through this now continuous detox, I feel better and better. With Lyme treatment, there are a few very predictable days a month that feel like major setbacks, but these are to be expected, and the feeling of a setback quickly goes away as a herx reaction ends.

I would never have been able to tolerate antibiotics and some other drugs if it weren't for jumpstarting my methylation. It took a while (and some detox and heavy metal chelation!) until the cycle was continuous. I don't know if this means I am on the road to a recovery (we don't hear about this often), but I can say I am on the road to getting better.

For support, I have switched over from ultra-high dose injections to low-dose sublingual. I initially stopped everything once the cycle was continuous. No, I don't really feel anything (maybe a better mood), but I figured I may as well continue to support my methylation cycle with low doses now even though I don't feel like I need it most of the time.

Truth be told: I think damage has been done, and I believe the slow improvements I feel may be the body slowly repairing physical and neurological damage as well as continue to detox the toxins that didn't come out when my methylation cycle was essentially blocked.

And to the poster that said:

It is also disturbing to see references to oxidation, methylation cycle, NAC, B12, treating co-infections etc. as a major component of treatment. These ideas have been floating around for years and I don't see any change in CFS treatment or prognosis. We need evidence of a heavy-hitting drug that works. Maybe it will never be found, but that is what it will take--you can't supplement your way out of this disease even if it may help a little around the edges.

I would have had a different take years ago, but I've seen and experienced the results based on supplementation, glutathione and treating lyme and various viruses.

In my experience, treating methylation was like using a "heavy-hitting drug that works." It has helped so many symptoms from lab documented episodes of hypoglycemia, anxiety, feeling of doom, constant low-grade fever 99.5 fever, various neurological issues, headaches, immune problems (I actually started getting viruses!), and just feeling toxic (I was right all along). Hell, I don't even drink alcohol anymore, but I tried some over Christmas break anyway, and I can actually tolerate it now without feeling deathly ill! In fact, it temporarily made me feel better than baseline. My cognition and brainfog is better. I don't word find as much in a conversation (I attribute this to both the methylation protocol and antimicrobials).

Now, I have been diagnosed with 2 of the most controversial diseases chronic Lyme and CFS. I did not seek these diagnoses, and sometimes I wish I were inflicted with an illness that was understood by the medical community.

And that being said, some of the most controversial treatments not really backed by mainstream research have helped me most. The top 2 on my list are colloidal silver and methylation support. And yes I have tried many expensive treatments (including intravenous therapies) supported by so-called evidence-based medicine. Unfortunately, as of now, evidence-based medicine really isn't where any of the answers lie. I am not discounting evidence-based medicine (hopefully trials find drugs that work!), but it has generally failed since the emergence of these neuro-immune diseases. However, with possible connections to retroviruses, we finally have a better idea of where to look, and I hope there will be more answers soon.
 
Hi, Kyle.

It continues to be heartwarming to me to hear of your progress. My hope is that you will in fact make it to full recovery, and also that this kind of response can be had more generally in the ME/CFS community.

Thanks very much for posting this update.

Best regards,

Rich
 
Cort, do we know for sure that WPI did in fact test the CFS samples multiple times but NOT the healthy controls? If this is a confirmed fact, it is a really big pitfall. Remember that one of the contamination theories attempting to explain the disparity between CFS and control samples is that the CFS samples were handled more than the controls. If the CFS samples were in fact handled more, that gives a toehold to the contamination theories (but does not prove it, obviously).

Actually, we know that the potential issue pointed out by Cort is categorically untrue: http://www.sciencemag.org/content/328/5980/825.4.full

Regarding the concern raised by Sudlow et al. (2) about potential expectation bias, we point out that the National Cancer Institute (NCI) and the Cleveland Clinic, whose scientists independently performed experiments and coauthored (1), were certainly not established as laboratories for the purpose of studying CFS. All samples were blinded, as mandated by the NCI and WPI institutional review board approvals. All experimental procedures were done by the same personnel, in the same physical laboratory space, under identical protocols. Investigators at NCI received 100 samples from individuals without knowing their health status; furthermore, the samples were sent to NCI directly without passing through the WPI laboratory space. Laboratory workers at the NCI and the WPI who performed the polymerase chain reaction (PCR) and immunological studies used coded, blinded samples that did not reveal the CFS status of the individuals.

So, at a minimum, the embedded confirmatory work by CC and NCI was blinded (including at least 100 samples).

This begs the broader question: how many times must these "misunderstandings" be corrected before it becomes clear that they are not unintentional but rather deliberate attempts to sow confusion and doubt?
 
Maybe Lannie or Cort can help me understand this. If WPI cannot confirm a sample is truly negative, then the Blood Working Group study is completely useless. But on the other hand, Dr. Mikovits seems to be completely confident in the negative results of testing of healthy people. This reads like a contradiction - either the positive/negative results are clear and reliable, or they are not. I don't understand how it can be both. Can anyone help me out?



I don't understand this either. Is Dr. Mikovits saying that patients cannot make antibodies to XMRV only? Or that a severely ill patient cannot make antibodies to lots of pathogens? The latter would suggest an AIDS-like presentation with the immune system completely unable to do its job. I know we have lots of co-infections, but that's different from an immune system unable to function by making antibodies. If Dr. Mikovits is saying patients can't make antibodies to XMRV alone, why would that be? Do they understand the mechanism for why the immune system would be unable to mount a response to one pathogen but not others?
Glad you brought these points up, JSpot. At least someone other than me has been wondering how these things can coexist.
How is it possible that we would selectively not be able to produce antibodies to XMRV when we are capable of producing antibodies to other pathogens? It seems to me I've heard this reasoning used in relation to TBDs also. If that were the case (i.e. a positive test means positive, but a negative test means you have it, but you just can't mount an antibody response) then testing would be useless. I would like to see the data to back up this reasoning, as it seems faulty.
 
C
Methylation work has not only made a significant impact on my symptoms, but has also greatly improved my medication tolerance capacity....without which, there would be little hope for me tolerating the arv's or other heavy meds.

Cort, my cytokines were that high....some higher.
 
Cort, do we know for sure that WPI did in fact test the CFS samples multiple times but NOT the healthy controls? If this is a confirmed fact, it is a really big pitfall. Remember that one of the contamination theories attempting to explain the disparity between CFS and control samples is that the CFS samples were handled more than the controls. If the CFS samples were in fact handled more, that gives a toehold to the contamination theories (but does not prove it, obviously).



Jonathan Stoye is confident in his results too. I love seeing confidence in CFS researchers, but it's not evidence one way or the other. Data data data!

I don't know that we know this....I think its been conjectured. What I remember is that we learned that some patient samples were tested repeatedly over time before they were positive and some researchers questioned whether the control samples were tested several times as well. I would hasten to point out that was when they were doing straight PCR and not the culturing that they are doing now - it appears that culturing is a one shot deal.
 
I would like to thank you Rich for all of your research and support.

I would consider myself re-methylated (ha, yes, I am making up words!), and I can't thank you enough.

As I go through this now continuous detox, I feel better and better. With Lyme treatment, there are a few very predictable days a month that feel like major setbacks, but these are to be expected, and the feeling of a setback quickly goes away as a herx reaction ends.

I would never have been able to tolerate antibiotics and some other drugs if it weren't for jumpstarting my methylation. It took a while (and some detox and heavy metal chelation!) until the cycle was continuous. I don't know if this means I am on the road to a recovery (we don't hear about this often), but I can say I am on the road to getting better.

For support, I have switched over from ultra-high dose injections to low-dose sublingual. I initially stopped everything once the cycle was continuous. No, I don't really feel anything (maybe a better mood), but I figured I may as well continue to support my methylation cycle with low doses now even though I don't feel like I need it most of the time.

Truth be told: I think damage has been done, and I believe the slow improvements I feel may be the body slowly repairing physical and neurological damage as well as continue to detox the toxins that didn't come out when my methylation cycle was essentially blocked.

And to the poster that said:



In my experience, treating methylation was like using a "heavy-hitting drug that works." It has helped so many symptoms from lab documented episodes of hypoglycemia, anxiety, feeling of doom, constant low-grade fever 99.5 fever, various neurological issues, headaches, immune problems (I actually started getting viruses!), and just feeling toxic (I was right all along). Hell, I don't even drink alcohol anymore, but I tried some over Christmas break anyway, and I can actually tolerate it now without feeling deathly ill! In fact, it temporarily made me feel better than baseline. My cognition and brainfog is better. I don't word find as much in a conversation (I attribute this to both the methylation protocol and antimicrobials).

Now, I have been diagnosed with 2 of the most controversial diseases chronic Lyme and CFS. I did not seek these diagnoses, and sometimes I wish I were inflicted with an illness that was understood by the medical community.

And that being said, some of the most controversial treatments not really backed by mainstream research have helped me most. The top 2 on my list are colloidal silver and methylation support. And yes I have tried many expensive treatments (including intravenous therapies) supported by so-called evidence-based medicine. Unfortunately, as of now, evidence-based medicine really isn't where any of the answers lie. I am not discounting evidence-based medicine (hopefully trials find drugs that work!), but it has generally failed since the emergence of these neuro-immune diseases. However, with possible connections to retroviruses, we finally have a better idea of where to look, and I hope there will be more answers soon.


Congratulations KDay...your post just reminds me that I still need to try out methylation... For me 10 or 20% improvement is GREAT! Every little bit helps and if you can plug together a couple off these improvements - I think you're really talking.
 
Actually, we know that the potential issue pointed out by Cort is categorically untrue: http://www.sciencemag.org/content/328/5980/825.4.full

So, at a minimum, the embedded confirmatory work by CC and NCI was blinded (including at least 100 samples).

This begs the broader question: how many times must these "misunderstandings" be corrected before it becomes clear that they are not unintentional but rather deliberate attempts to sow confusion and doubt?

Well, this is what appeared in an article I wrote in March of this year

WPI researchers Had to Search Multiple Times Both in Time and Space to Find the Virus - Not only did they look at a sample multiple times they had to look at samples taken at different times from the same patient in order to find the virus

http://aboutmecfs.org/Rsrch/XMRVZapped.aspx

I don't have the original statement... My impression was that it applied to the Science study and that's the context it appeared in - but its possible that's wrong, and if so I apologize. I was under the impression that Dr. Mikovits accounted for some of the difficulty finding the virus by stating at one point that they had to search at multiple time points and multiple samples to find it but I can't find that statement.
 
rich and kyle,

thanks for the great info. So would i need to get a prescription for Metafolin from my doctor - as it seems to be a medicinal food. I will try and get a script tommorow. I can't seem to find any decent suppliers online for the UK.

So if I take Metafolin and Klye might I ask where you get the methylcobalamin b12 injects from? do you know if sarah myhill is back on the scene and able to supply them again? i used to get some b12 injects from her but i just realised its the rather dodged cynaocobalamin (cyanide bonded?)

So ideally if i start with: Metafolin, methylcobalamin (injection), high dose quality vitamin, amino acid mix tablets.

Do you think this is the best way to start rich?, I would like to give this another shot if I have been taking suboptimal type of folic acid.

My biggest problem is getting methylcobalamin injections i need to find a source!! arghhh

Kyle its great to hear you have had such a great improvement, I hope I am able to replicate some of your success.

Rich thanks for sharing all your knowledge with others, I want to give this another shot!

Thanks,

Jake
 
So, at a minimum, the embedded confirmatory work by CC and NCI was blinded (including at least 100 samples).

The Cleveland Clinic tested 11 patient samples, but I don't recall any reference to them receiving any controls. It's not explicit in the paragraph you quote that CC was blinded to the CFS status of those 11 samples, although they certainly could have been.

The paragraph you quote says NCI received 100 samples, but the Virulence 2010 paper says 48 patient samples were sent to NCI. I don't recall any reference to NCI receiving additional patient or control samples, so the 100 number confuses me. The Virulence paper also says those 48 samples were collected by the Sierra Internal Medicine practice and sent to NCI. Is it possible that someone at NCI (who not a lab worker who performed the PCR) knew the patient status of samples? For example, Maureen Hanson was unblinded to the CFS status of her patient/control samples so she could present results but her lab workers are still blinded.

This begs the broader question: how many times must these "misunderstandings" be corrected before it becomes clear that they are not unintentional but rather deliberate attempts to sow confusion and doubt?

I just reread a couple of these papers yesterday so certain points are fresh in my mind. I find it very easy to get confused about sample numbers, tests run, etc. and I've paid closer attention than many patients I know. I think misunderstandings and misrememberings are quite possible without them being deliberate attempts to sow confusion and doubt.
 
rich and kyle,

thanks for the great info. So would i need to get a prescription for Metafolin from my doctor - as it seems to be a medicinal food. I will try and get a script tommorow. I can't seem to find any decent suppliers online for the UK.

So if I take Metafolin and Klye might I ask where you get the methylcobalamin b12 injects from? do you know if sarah myhill is back on the scene and able to supply them again? i used to get some b12 injects from her but i just realised its the rather dodged cynaocobalamin (cyanide bonded?)

So ideally if i start with: Metafolin, methylcobalamin (injection), high dose quality vitamin, amino acid mix tablets.

Do you think this is the best way to start rich?, I would like to give this another shot if I have been taking suboptimal type of folic acid.

My biggest problem is getting methylcobalamin injections i need to find a source!! arghhh

Kyle its great to hear you have had such a great improvement, I hope I am able to replicate some of your success.

Rich thanks for sharing all your knowledge with others, I want to give this another shot!

Thanks,

Jake

Hi, Jake.

Metafolin is available in the UK from http://bigvits.co.uk/product.asp?pid=229&cid=&tid=&bid=27 This is a Solgar product, and it is the genuine Merck material.

Sublingual methylcobalamin in 1,000 microgram sublingual chunks is available in the UK from

http://www.solgar.co.uk/modules/catbuild/files/Methylcobalamin1000mcg30NuggetsE1950.htm This is also a Solgar product.

Dr. Myhill is not giving B12 or magnesium injections at the moment, pending her hearing in High Court to try to lift the restrictions placed on her practice by the GMC. But sublingual works O.K.

Yes, a multivitamin, multimineral with substantial but safe dosages of the essential nutrients (not RDA levels) is important.

Supplying amino acids can also be important, particularly methionine, serine, cysteine and glycine.

Support for the lipid membranes is important, too. The simplified protocol uses a phosphatidyl serine complex, which contains a range of phospholipids. This is also available in the UK from Solgar: http://www.solgar.co.uk/modules/catbuild/files/PhosphatidylSerineComplex500mg30TabletsE2803.htm

I hope this helps. It's important to be working with a physician while on this type of treatment, because a small number of people have reported serious adverse effects while on it.

Best regards,

Rich
 
Dr. Mikovits Talks!

I'm SO glad to hear that Dr. Mikovits is still talking about Peptide T. I am putting a lot of hope in that, since it would be a non-toxic treatment. It seems like the one treatment I could really tolerate.
 
In discussing tests, another very important take away was that if you test positive you are positive. If you test negative, they are not able to confirm it is absolutely negative.

Maybe Lannie or Cort can help me understand this. If WPI cannot confirm a sample is truly negative, then the Blood Working Group study is completely useless. But on the other hand, Dr. Mikovits seems to be completely confident in the negative results of testing of healthy people. This reads like a contradiction - either the positive/negative results are clear and reliable, or they are not. I don't understand how it can be both. Can anyone help me out?

Mikovits noted “especially the sickest, get negative antibody response, but positive culture.”

Although it's a bit unclear in the blog, the first quote above is made in the context of a paragraph stressing the importance of BOTH tests - culture and serology. You can be negative by serology but positive by culture and this seems to happen more often among the sickest patients. Thus, culture is apparently the more reliable test (particularly if you are among the sickest), but it is also the more time consuming. It's not clear from Lannie's blog that they are saying that you could still be positive if both tests are negative (although this may have been said elsewhere).
 
All samples were blinded, as mandated by the NCI and WPI institutional review board approvals. All experimental procedures were done by the same personnel, in the same physical laboratory space, under identical protocols. Investigators at NCI received 100 samples from individuals without knowing their health status; furthermore, the samples were sent to NCI directly without passing through the WPI laboratory space. Laboratory workers at the NCI and the WPI who performed the polymerase chain reaction (PCR) and immunological studies used coded, blinded samples that did not reveal the CFS status of the individuals.
 
If WPI cannot confirm a sample is truly negative, then the Blood Working Group study is completely useless. But on the other hand, Dr. Mikovits seems to be completely confident in the negative results of testing of healthy people. This reads like a contradiction - either the positive/negative results are clear and reliable, or they are not. I don't understand how it can be both. Can anyone help me out?

Simples.

If one were consistently finding - say - 80% in ME patients and 5% in healthy controls, on a relatively new test, one could be reasonably confident that the vast majority of negatives really are negatives, and that the positives are all positives (especially if also confirmed by other methods) but still think that the test is capable of further improvement and greater sensitivity.

For example, if one had a test that happened to detect XMRV 98% of the time when it was there, then the true figures above would actually be more like 82% and 5.1%.

As I read it, the source of confusion in the quote above is that Dr Mikovits' "confidence in the negative results of testing of healthy people" is a confidence that 95+% of them really are negative - just as most of the negatives of ME patients are probably negative - and a confidence that the results overall are basically correct. But for an individual, there's no guarantee: Dr Mikovits - I presume - isn't confident that the negative results in healthy controls are 100% accurate, but rather she's confident that they're 95% accurate, and very different from the results seen in ME patients. I don't think the WPI have ever claimed their test is 100% sensitive.

The point that your question does highlight is that it's true that the WPI can't actually confirm that a given sample is truly negative - just as the negative studies failing to find something doesn't prove that it isn't there - so yes, the negative samples for the BWG were not guaranteed.

And yes, the Blood Working Group study does appear to have been completely useless, for all kinds of reasons, not least because they only tested on such a tiny handful of samples.

Many types of tests have either 'guaranteed' specificity or 'guaranteed' sensitivity, but not both. So sometimes you can be sure that all the positives really are positives, but there may be a few false negatives - or the other way around.

Since XMRV is clearly very hard to detect, and present in low copy numbers in the blood, and is believed to reside primarily in as-yet-unknown tissue reservoirs, it's no surprise for the WPI to be saying to patients who tested negative that this does not necessarily mean they don't have XMRV that the WPI can't find yet.

Bearing in mind that the WPI have moved from (roughly) 67% vs 3.7% to (rough guess) 90% vs 7%, this does all make sense to me.


Is Dr. Mikovits saying that patients cannot make antibodies to XMRV only? Or that a severely ill patient cannot make antibodies to lots of pathogens?...If Dr. Mikovits is saying patients can't make antibodies to XMRV alone, why would that be? Do they understand the mechanism for why the immune system would be unable to mount a response to one pathogen but not others?

I don't think Dr. Mikovits has said whether the serology-negative patients are also negative for antibodies to other infections they have, so that would seem like an open question at this point - so far, she's just reported her findings on testing. But it's an interesting question - "why the immune system would be unable to mount a response to one pathogen but not others?" - so I've pondered it and come up with a hypothesis...

We already have this emerging model whereby XMRV may cause the chronicity of co-infections by infecting the specific B/T-cells that generate the relevant antibodies to those co-infections (or by a similar mechanism). Thus 'lyme disease' becomes 'chronic lyme disease' because XMRV has subverted the immune response to lyme; EBV becomes ME because XMRV has subverted the immune response to EBV; chemical and environmental sensitivities become extreme because XMRV has infected the relevant antibodies. (The details of this mechanism are vague and are still emerging, but that rough description is how it's looked to me for quite some time now, and my best guess is that XMRV acts as a parasite on whatever immune responses are active at the time of infection with XMRV).

Soooo....is it possible that, ultimately, XMRV can also get even further behind the defences, and subvert the immune response to itself?...

That whole line of reasoning is based on the premise that XMRV functions by subverting the immune response, in some way. But there's a second possibility that also springs to mind...

Production of antibodies requires specific resources. If those specific resources are depleted due to constant production of something that isn't working ("firing blanks") or due to methylation blocks suppressing production of enzymes necessary to digest specific proteins, then it seems plausible to me that specific antibodies might not be produced any longer. But if the problems were all fundamentally caused by infection and a constant immune response, then getting that infection partially cleared might clear up these roadblocks and enable the body to start producing XMRV antibodies again.

Oh...and here's a third theory...perhaps some people's immune response to XMRV is failing because the body hasn't noticed it, or has given up fighting it, because it's been chronic for so long and fighting it isn't working. But then when you help out with anti-retrovirals, the body wakes up again to the presence of something it had given up on. We should expect the involvement of previously-unknown behaviours of the immune system here - this is frontier stuff, after all...

Hope that makes sense...just speculation really, but these rough sketches seem to me like plausible explanations of these puzzles.
 
Some researchers pointed out a similar issue showed up in the Science paper where it appeared that the WPI retested people with CFS in their attempt to find the virus but did not retest the healthy control samples. They assumed a negative control was a negative control but a negative patient might be a postiive - so they retested some patients several times - thus trying harder to find the virus in them.

Cort,

This is a very confusing statement, which seems meant to imply serious, biased flaws to the WPI's work.

Their work, a joint effort with the National Cancer Institute, and the Cleveland clinic, for this study, was Peer Reviewed for over 6 months,and then published by the one of the World's top 2 Scientific Journals.

Please clarify your comments: What "researchers" are you referring to, exactly what did they say, and based on what?

Please provide quotes, and clearly distinguish between them and your paraphrasing.

Thank you,

Katrina