https://www.mdpi.com/2227-9032/6/4/124

Healthcare 2018, 6(4), 124; https://doi.org/10.3390/healthcare6040124

Removing the Mask of Average Treatment Effects in Chronic Lyme Disease Research Using Big Data and Subgroup Analysis

1MyLymeData, Chico, CA 95927, USA
2Analytic Designers LLC., Bethesda, MD 20817, USA
3Paul G. Allen School of Computer Science and Engineering, University of Washington, Seattle, WA 98195, USA
Author to whom correspondence should be addressed.
Received: 4 September 2018 / Revised: 9 October 2018 / Accepted: 9 October 2018 / Published: 12 October 2018
Full-Text   |   PDF [1495 KB, uploaded 12 October 2018]

Abstract

Lyme disease is caused by the bacteria borrelia burgdorferi and is spread primarily through the bite of a tick. There is considerable uncertainty in the medical community regarding the best approach to treating patients with Lyme disease who do not respond fully to short-term antibiotic therapy. These patients have persistent Lyme disease symptoms resulting from lack of treatment, under-treatment, or lack of response to their antibiotic treatment protocol. In the past, treatment trials have used small restrictive samples and relied on average treatment effects as their measure of success and produced conflicting results. To provide individualized care, clinicians need information that reflects their patient population. Today, we have the ability to analyze large data bases, including patient registries, that reflect the broader range of patients more typically seen in clinical practice. This allows us to examine treatment variation within the sample and identify groups of patients that are most responsive to treatment. Using patient-reported outcome data from the MyLymeData online patient registry, we show that sub-group analysis techniques can unmask valuable information that is hidden if averages alone are used. In our analysis, this approach revealed treatment effectiveness for up to a third of patients with Lyme disease. This study is important because it can help open the door to more individualized patient care using patient-centered outcomes and real-world evidence. View Full-Text

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**Comment**
Great work here.  We need to start the coinfection discussion; however, as Lyme is just one beast of many and the involvement of other pathogens muddies the water considerably and needs addressing.  Many, many patients WILL NOT improve on a Lyme only treatment.

 

 

 

 

https://www.ncbi.nlm.nih.gov/m/pubmed/30007502/

Transmission of the relapsing fever spirochete, Borrelia miyamotoi, by single transovarially-infected larval Ixodes scapularis ticks.

Breuner NE, et al. Ticks Tick Borne Dis. 2018.

Abstract

The relapsing fever spirochete, Borrelia miyamotoi, is increasingly recognized as a cause of human illness (hard tick-borne relapsing fever) in the United States. We previously demonstrated that single nymphs of the blacklegged tick, Ixodes scapularis, can transmit B. miyamotoi to experimental hosts. However, two recent epidemiological studies from the Northeastern United States indicate that human cases of hard tick-borne relapsing fever peak during late summer, after the spring peak for nymphal tick activity but coincident with the peak seasonal activity period of larval ticks in the Northeast. These epidemiological findings, together with evidence that B. miyamotoi can be passed from infected I. scapularis females to their offspring, suggest that bites by transovarially-infected larval ticks can be an important source of human infection. To demonstrate experimentally that transovarially-infected larval I. scapularis ticks can transmit B. miyamotoi, outbred Mus musculus CD1 mice were exposed to 1 or 2 potentially infected larvae. Individual fed larvae and mouse blood taken 10 d after larvae attached were tested for presence of B. miyamotoi DNA, and mice also were examined for seroreactivity to B. miyamotoi 8 wk after tick feeding.

We documented B. miyamotoi DNA in blood from 13 (57%) of 23 mice exposed to a single transovarially-infected larva and in 5 (83%) of 6 mice exposed to two infected larvae feeding simultaneously. All 18 positive mice also demonstrated seroreactivity to B. miyamotoi. Of the 11 remaining mice without detectable B. miyamotoi DNA in their blood 10 d after infected larvae attached, 7 (64%) had evidence of spirochete exposure by serology 8 wk later.

Because public health messaging for risk of exposure to Lyme disease spirochetes focuses on nymphal and female I. scapularis ticks, our finding that transovarially-infected larvae effectively transmit B. miyamotoi should lead to refined tick-bite prevention messages.

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**Comment**

A mother tick CAN transmit to her own children.  (Just as human mothers can):  https://madisonarealymesupportgroup.com/2018/06/19/33-years-of-documentation-of-maternal-child-transmission-of-lyme-disease-and-congenital-lyme-borreliosis-a-review/

This is why it is unwise to focus on months of the year regarding when you can and can not become infected.  First, ticks are marvelous ecoadaptors and can survive the harshest environments:  https://madisonarealymesupportgroup.com/2018/08/13/study-shows-lyme-not-propelled-by-climate-change/.  Second, we can’t just be concerned with one stage of the tick but recognize the potential transmission of ALL stages to infect.

There’s a high probability more than ticks can transmit:  https://madisonarealymesupportgroup.com/2017/02/24/pcos-lyme-my-story/

Then, there’s the added complexity of being able to transmit many things simultaneously:  https://madisonarealymesupportgroup.com/2017/07/01/one-tick-bite-could-put-you-at-risk-for-at-least-6-different-diseases/

They are finding ticks in places they shouldn’t be making geographical maps virtually useless:  https://madisonarealymesupportgroup.com/2018/07/16/ticks-that-carry-lyme-disease-are-spreading-fast/  (Please also read my comment at end of article)

Time for researchers to quit sounding so “all knowing,” and write research articles carefully, making sure to remember that what they write will and has been used against patients in every possible way imaginable.
Plus, everything they thought they knew is constantly changing.

Recently Lymedisease.org came out with this:  https://www.lymedisease.org/2018-lyme-disease-resource-list/ and within this link you can find out numerous things including a symptom checklist, the ability to purchase an informative quarterly journal they put out, find their Facebook and Twitter accounts, online support groups and sign up for a free newsletter.  All of that is dandy.

What isn’t dandy is the physician directory they offer.

Here’s why.

Lyme/MSIDS is a political hotbed – particularly for physicians and practitioners.  State medical boards have come after these folk (think witch hunt) for prescribing outside the CDC guidelines (which essentially state 21 days of doxycyline will cure you) and then descend upon them like the Spanish Inquisition.  Many doctors have lost their license to practice in this way.  

You’d think with all of the people getting infected that this would change.  But it hasn’t.  

The problem with a static list created by folks not in your state is the list of doctors is forever influx.  As I look at the list for my state of Wisconsin, there’s folks on there I haven’t even heard of, and that’s not good as I’m heavily involved in the vetting process of obtaining the necessary information making sure the doctors on our list are properly trained by ILADS.  There’s also many more doctors properly trained who aren’t on their list at all.

Why ILADS?  Glad you asked.

At this point in the game, there are two sides to the Lyme/MSIDS Wars: 

  1. CDC/NIH/IDSA camp that believes Lyme is hard to catch and simple to treat with 21 days of doxy.  If you have symptoms after that they believe it’s something other than Lyme and are likely to give you an anti-depressant.  They deny persistent/chronic infection and believe there’s only between 10-20% of us out here who suffer with symptoms after treatment.  They call this PTLDS (of unknown cause) – but they state emphatically isn’t due to a persistent infection.  They also aren’t factoring in coinfections at all.  They treat you with a one drug for one pathogen paradigm, which only works on acute cases and even then sometimes doesn’t work.  Also, due to the disbelief in persistence, their treatment times are extremely short.  All of their studies are of short duration on antibiotic usage with virtually little to no follow-up  – rigged from the get-go for those of us with chronic symptoms.
  2. ILADS camp looks at animal studies proving persistent/chronic infection and extrapolates that out to humans.  They believe this is a complex illness with a lot of moving pieces and parts which requires a clinical diagnosis and treatment regimen, specifically designed to the individual.  They take coinfections into account and treat accordingly with whatever drugs are necessary to get the job done.  They also treat longer as the understand how these pathogens work symbiotically to modulate the immune system making our cases tougher.  Depending upon the case, treatment could go from weeks to life-long as each case varies tremendously.  They also understand many of these pathogens are spread congenitally, via breast milk, and even sexually and treat accordingly.  They also understand the immune system component but that often the infection is driving it.
All of that to say this:  If they are not ILADS trained, there is NO WAY we can insure they are properly educated to treat this monster.
Where should you go to find educated doctors?

I highly recommend you contact your local Lyme support Group for this information.  These are the folks with boots on the ground experience in your state who are familiar, or can point you to someone with accurate and up to date information on how to find a properly trained doctor.  In the state of Wisconsin, Wisconsin Lyme Network (WLN) http://wisconsinlymenetwork.org/ is your go-to source for the trained doctor list as well as other valuable information.  They are actively involved in raising funds/accepting donations to get Wisconsin doctors properly trained, raise awareness, provide education and support, and promote research for vector-borne illnesses to patients, medical community and  the general Wisconsin population.  Check to see if your state has such an organization that serves as a clearinghouse of vetted information, particularly on doctors.

Local support groups will be able to help you with costs, treatment style, and nuances that are indispensable such as:

  1. Treatment style.  Believe it or not there is a wide girth of treatment styles even within ILADS. (this is important as one physician in Wisconsin uses primarily ozone which requires weekly treatments in-house, requiring a long drive for many)
  2. How long it takes to get an appointment
  3. How often you must be seen
  4. How they handle complications
  5. Whether they are good at returning phone calls or not
  6. If the office staff is rude
  7. If they do in-house blood work
  8. If they accept insurance
  9. If they have supplements in house for purchase
  10. If they have adjunctive treatments they offer (this is important because often you have to be a patient to use these.  For instance if you wanted to try ozone, chelation, hyperbaric, or Biomat, if you are not their patient, you probably would have to pay a “new patient” fee to utilize their service.)

Those are just things off the top of my head but there are probably 1,000 more details such as this that you will be able to query your local support group for or even discover important questions to ask.  These groups really are indispensable FREE reservoirs of information that you should take advantage of.

Why is this important?

Personally, I remember when I started this journey riddled with pot-holes.  I had symptoms that nearly led me to the ER, I knew nothing about what I’m telling you now, and had to essentially reinvent the wheel.  That is not fun when you can’t remember words and forget why you walked into a room.

Thankfully, I had presence of mind enough to email my local support group which taught me a number of these things in short order, giving me the cherished and coveted list of Lyme-literate doctors for my state so at least I could make somewhat of an educated guess.  Looking back, I wish I would have gone to group in person to ask more questions as it would have been even more helpful to understand costs, regimens, and the personality of the offices and doctors involved.  **Caveat** Please keep in mind some folks might have had a negative experience with a certain doctor.  Try to balance all opinions and in the end, make sure to ask the support group leader’s opinion as typically they are experienced or can point you to someone who is to bounce all the feedback onto.  Sometimes the negative experience isn’t even the doctor’s fault but a misunderstanding or even due to the patient himself.  To say patients can be psychologically impaired at times which can affect our judgment would be an understatement.

Since treatment is often years long, you want to find someone that works with you.  These doctors, bless them, are often mavericks of one sort or another as it takes special people to deal with the likes of us and handle the inherent risks of the political issue and the polarization of the medical community.  These are stand-alone individuals who have defied convention and that often leads to some interesting personality-types.

On top of this, issues such as convenience can become important as treatment is often long & complex, so having the ability to get blood work done in house, purchase supplements in one stop, and have access to adjunctive treatments can really simplify life which has already been made extremely complex due to this illness.

And lastly, don’t feel badly if at some point you need to change doctors or even have numerous ones.  Since this complex illness can and often affects the entire body, it’s nearly impossible for ONE practitioner to be able to handle it all.  You might very well need someone experienced with diet and nutrition on top of a Lyme literate doctor, as well as a physical therapist, chiropractor, psychiatrist, and more.  Everyone is entirely different.

 

 

 

 

 

https://www.ncbi.nlm.nih.gov/m/pubmed/29954419/

Multilocus sequence typing of clinical Borreliella afzelii strains: population structure and differential ability to disseminate in humans.

Gallais F, et al. Parasit Vectors. 2018.

Abstract

BACKGROUND: Lyme borreliosis in humans results in a range of clinical manifestations, thought to be partly due to differences in the pathogenicity of the infecting strain. This study compared European human clinical strains of Borreliella afzelii (previously named Borrelia afzelii) using multilocus sequence typing (MLST) to determine their spatial distribution across Europe and to establish whether there are associations between B. afzelii genotypes and specific clinical manifestations of Lyme borreliosis. For this purpose, typing was performed on 63 strains, and data on a further 245 strains were accessed from the literature.

RESULTS: All 308 strains were categorized into 149 sequence types (STs), 27 of which are described here for the first time. Phylogenetic and goeBURST analyses showed short evolutionary distances between strains. Although the main STs differed among the countries with the largest number of strains of interest (Germany, the Netherlands, France and Slovenia), the B. afzelii clinical strains were less genetically structured than those previously observed in the European tick population.

Two STs were found significantly more frequently in strains associated with clinical manifestations involving erythema migrans, whereas

another ST was found significantly more frequently in strains associated with disseminated manifestations, especially neuroborreliosis.

CONCLUSIONS: The MLST profiles showed low genetic differentiation between B. afzelii strains isolated from patients with Lyme borreliosis in Europe.

Also, clinical data analysis suggests the existence of lineages with differential dissemination properties in humans.

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**Comment**

This research highlights why thousands of patients remain undiagnosed. CDC two-tiered testing tests for ONE STRAIN of borrelia.  ONE.  There are 300 strains and counting worldwide.

It also shows how the differences between strains matter.  In this study, some strains were associated with the EM rash, while others were associated with disseminated symptoms – particularly neuroborreliosis.

Huh.  Guess we weren’t making it all up after all.
Could someone give the memo to the CDC, NIH, & IDSA?

 

 

 

 

 

 

 

 

I’ve been sitting on this article for a while but with the push for gene-editing on mice and insects feel compelled to share it now while the iron’s hot.  To understand how this relates to Lyme/MSIDS, please see my comment at the end of the article.

https://worldmercuryproject.org/news/altering-human-genetics-through-vaccination/

June 28, 2018

Altering Human Genetics Through Vaccination

Children’s Health Defense Note: CHD has internal documents in which the FDA acknowledges that technology that allows for the creation of these new vaccines has outpaced their ability to predict adverse events. Shouldn’t our federal agencies be calling for a moratorium until we have that knowledge—especially since it is heavily reported that the CDC/FDA post-marketing surveillance systems are inadequate to pick up problems after licensure?

By Jon Rappoport, Contributing Writer, Children’s Health Defense

The National Institute of Allergy and Infectious Diseases (NIAID) has launched efforts to create a vaccine that would protect people from most flu strains, all at once, with a single shot.

Over the years, I’ve written many articles refuting claims that vaccines are safe and effective, but we’ll put all that aside for the moment and follow the bouncing ball.

Massachusetts Senator and big spender, Ed Markey, has introduced a bill that would shovel no less than a billion dollars toward the universal flu-vaccine project.

Here is a sentence from an NIAID press release that mentions one of several research approaches:

“NIAID Vaccine Research Center scientists have initiated Phase 1/2 studies of a universal flu vaccine strategy that includes an investigational DNA-based vaccine (called a DNA ‘prime’)…”

This is quite troubling, if you know what the phrase “DNA vaccine” means. It refers to what the experts are touting as the next generation of immunizations.

Instead of injecting a piece of a virus into a person, in order to stimulate the immune system, synthesized genes would be shot into the body. This isn’t traditional vaccination anymore. It’s gene therapy.

In any such method, where genes are edited, deleted, added, no matter what the pros say, there are always “unintended consequences,” to use their polite phrase. The ripple effects scramble the genetic structure in numerous unknown ways.

This is genetic roulette with a loaded gun. Anyone and everyone on Earth injected with a DNA vaccine will undergo permanent and unknown genetic changes…
Here is the inconvenient truth about DNA vaccines—
They will permanently alter your DNA.

The reference is the New York Times, 3/15/15, “Protection Without a Vaccine.” It describes the frontier of research—the use of synthetic genes to “protect against disease,” while changing the genetic makeup of humans. This is not science fiction:

“By delivering synthetic genes into the muscles of the [experimental] monkeys, the scientists are essentially re-engineering the animals to resist disease.”

“’The sky’s the limit,’ said Michael Farzan, an immunologist at Scripps and lead author of the new study.”

“The first human trial based on this strategy — called immunoprophylaxis by gene transfer, or I.G.T. — is underway, and several new ones are planned.” [That was three years ago.]

“I.G.T. is altogether different from traditional vaccination. It is instead a form of gene therapy. Scientists isolate the genes that produce powerful antibodies against certain diseases and then synthesize artificial versions. The genes are placed into viruses and injected into human tissue, usually muscle.”

Here is the punchline:

“The viruses invade human cells with their DNA payloads, and the synthetic gene is incorporated into the recipient’s own DNA. If all goes well, the new genes instruct the cells to begin manufacturing powerful antibodies.”

Read that again: “the synthetic gene is incorporated into the recipient’s own DNA.”

Alteration of the human genetic makeup.

Not just a “visit.” Permanent residence. And once a person’s DNA is changed, he will live with that change—and all the ripple effects in his genetic makeup—for the rest of his life.

The Times article taps Dr. David Baltimore for an opinion:

“Still, Dr. Baltimore says that he envisions that some people might be leery of a vaccination strategy that means altering their own DNA, even if it prevents a potentially fatal disease.”

Yes, some people might be leery.  If they have two or three working brain cells.

This is genetic roulette with a loaded gun. Anyone and everyone on Earth injected with a DNA vaccine will undergo permanent and unknown genetic changes…

And the further implications are clear. Vaccines can be used as a cover for the injections of any and all genes, whose actual purpose is re-engineering humans in far-reaching ways.

The emergence of this Frankenstein technology is paralleled by a shrill push to mandate vaccines, across the board, for both children and adults. The pressure and propaganda are planet-wide.

The freedom and the right to refuse vaccines has always been vital. It is more vital than ever now.

It means the right to preserve your inherent DNA.

The author of three explosive collections, THE MATRIX REVEALED, EXIT FROM THE MATRIX, and POWER OUTSIDE THE MATRIX, Jon was a candidate for a US Congressional seat in the 29th District of California. He maintains a consulting practice for private clients, the purpose of which is the expansion of personal creative power. Nominated for a Pulitzer Prize, he has worked as an investigative reporter for 30 years, writing articles on politics, medicine, and health for CBS Healthwatch, LA Weekly, Spin Magazine, Stern, and other newspapers and magazines in the US and Europe. Jon has delivered lectures and seminars on global politics, health, logic, and creative power to audiences around the world. You can sign up for his free NoMoreFakeNews emails here or his free OutsideTheRealityMachine emails here.

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**Comment**

Frightening information, indeed, and reminiscent of Brave New World.

Hopefully regarding DNA based (gene-editing) vaccines, the evidence for harm is self-evident.

Regarding how this specifically could affect Lyme/MSIDS patients, the vaccine issue should STILL be self evident in the harm it could cause chronically/persistently infected people, but secondly, they are gene-editing mice and mosquitoes and releasing them into the wild in hopes of eradicating Lyme and Zika with unintended consequences:  https://madisonarealymesupportgroup.com/2018/10/11/new-england-scientists-explore-new-method-for-eradicating-lyme-disease/

In brief, gene editing has shown unintended consequences of mutations, enhancement of other pathogens, cancer in humans, and very real ethical issues. 

Lastly, while many think the only problem some have with aborted fetal tissue in vaccines is only an ethical one, I was told by people with far more experience than I, that putting human DNA from a certain gender into another human of a different gender, could also have unintended consequences – transgenderism.

Please read my entire comment at end of article within link.  This is scary business.  Please speak out in your sphere of influence.