CTN Tick-borne Disease Pilot Treatment Study Award
We are happy to announce that the Clinical Trials Network established with a grant from the Steven & Alexandra Cohen Foundation to Columbia University announces the third round of Pilot Study Proposal submissions (January 15 to March 15, 2023).
The Clinical Trials Network welcomes clinicians, researchers, and investigators from academic institutions to submit proposals. The proposals are typically 1-3 pages in length, but longer proposals are accepted for review. The CTN’s goal is to support the conduct of small-scale human treatment studies related to treatment of Lyme and other tick-related diseases. These small pilot studies are conducted to determine whether future larger investigations are warranted. Pilot studies often assess safety and feasibility, are exploratory in nature, and are not meant to answer the same questions as larger randomized control trials.
The CTN Study Review Committee will review submissions for consideration for further development into a pilot study; each pilot study will be conducted at one of the CTN investigation sites. The CTN has funding to support 1-2 small pilot studies each year.
Current CTN network affiliates include investigators from Columbia University Irving Medical Center in New York City, Johns Hopkins University Medical Center in Baltimore Maryland, and Children’s National Hospital in Washington D.C. The CTN Study Review Committee includes the core CTN members, clinical research experts, and academic and community clinicians. Results of the CTN pilot studies – if favorable – will lead to consideration for larger Randomized Controlled Trials.
The deadline for the first round of submissions for treatment research ideas from the research scientists and clinicians is March 15, 2023. The submission period opens January 15, 2023.
We thank all clinicians and investigators in advance for participation in this process, as your proposal may lead to a transformative study.
The fear here is that if this leads to human trials, only those who test positive with an EM rash will qualify, persistent infection will be once again denied, and the continued use of PTLDS will be utilized which will once more omit the sickest patients that are seronegative and without the rash. This affects everything and hasn’t changed in 40 years. The entire premise and paradigm is wrong but continues to be utilized in tick-borne disease research.
ALERT: World Health Organization Meeting this Week to Propose Amendments to the International Health Regulations
WHO director Tedros with NIAID director Dr. Anthony Fauci in 2018 signing a memorandum of understanding between NIAID and WHO to enhance future collaborations on research activities conducted in response to emerging infectious disease outbreaks and public health emergencies. Image Source.
Comments by Brian Shilhavy Editor, Health Impact News
Jan. 12, 2023
James Roguski has been making the media rounds in the Alternative Media this week warning about a closed-door meeting happening at the World Health Organization (WHO) this week with The International Health Regulations Review Committee (IHRRC) from January 9-13, 2023.
While the new WHO proposed “Pandemic Treaty” has grabbed the headlines in recent weeks, James Roguski believes that the meeting this week with IHRRC is much more important, because they are proposing amendments to an agreement that all 194 member nations of the World Health Assembly have already signed and ratified, including the United States, back in 2005, regarding International Health Regulations.
The current agreement is “non-binding”, but according to Roguski they want to change the agreement to remove the wording that states these “health regulations” are not just non-binding recommendations, but requirements to be implemented in all future “pandemics.”
The Review Committee is supposed to submit their proposals to the WHO by January 15, 2023, and then the entire 194 members of the WHO could vote on these amendments as soon as this May, in 2023. The amendments could be ratified by a simple majority vote among the 194 member nations.
Go to top link for one of the interviews he gave yesterday about these proposed amendments, and you can learn more from James Roguski’s Substack account here.
And go here to read an interview with Francis Boyle, J.D., Ph.D., bioweapons expert and professor of international law at the University of Illinois, on how the WHO’s latest proposals may violate international law. He calls for the U.S. federal and state governments to exit the WHO immediately.
Go here to learn more about WHO Director Tedros Gherbreyesus, who according to Roguski would become the World Ruler for all health measures in future pandemics.
According to an article written last year, the U.S. is on course to become a ‘digital dictatorship’ under a proposed biomedical research agency. This agency would merge national security with public health, a perfect formula for a dangerous agenda that would destroy medical freedom as we know it.
This agency would “use both physical and mental health ‘warning signs’ to prevent outbreaks of disease or violence before they occur. Such a system is a recipe for a technocratic ‘pre-crime’ organization with the potential to criminalize both mental and physical illness as well as ‘wrongthink.’”
This article proves the political interference at HHS as well as the fact governments are working in lockstep to bring in digital I.D.s & a social credit system.
Translational Failure: Nature Medicine Inmate Study Removes >99% of the Data, Is Used to Conclude that COVID-19 Vaccines Reduce Transmission. PR Score: F-
Study restricts consideration of close contact inmates (who shared cells). As if non-close contacts do not transmit, and as if prison cell settings are relevant for the world outside the Big House.
This is not an academic note. Your representatives, family members, and school boards must know that science on efficacy has been warped just as much as science on safety.
A hugely important part of epidemiologic studies is whether the study sample – the group(s) of people being studied – is representative of the general population about which generalizable knowledge is sought.
The problem for the WHO, CDC, FDA, NIAID, Fauci, and people who message and think like these organizations is this: you cannot debunk reality.
This issue is so important that when I read an observational study, such as this one in Nature Medicine, entitled “Infectiousness of SARS-CoV-2 breakthrough infections and reinfections during the Omicron wave”, the first part of the study I read the section that describes the inclusion/exclusion criteria and compares the outcome of the exclusions to the general population for which knowledge is sought. With a title as general as this, one would think that the study has general relevance to the question of whether COVID-19 mRNA vaccines and infections protect against infection and re-infection.
For such a study, I then look to see whether the study found a difference or association (or no difference or association), and then only could report a difference following statistical adjustment for variables. It is truly important to know how the various results were chosen; which variables were selected as confounders, and then, importantly, whether the confounders are suspected (weak) or if previous functional relationships of the type necessary to use the label “confounder”, rather then “covariate”, are known.
Study Earns a Popular Rationalists Score of F- on Generalizability
The study in question involves data from prisons in California’s penal system (hardly a representative population or setting relevant to the rest of society). The following inmates were excluded:
those who were not held in cells with other inmates
those who did not have housing or prior COVID-19 test result data
likely to have tested positive for a variant other than Omicron
housed in a small institution
negative PCR test during the infectious period (risk: false negative results)
had contacts w/inmates w/positive test +/- 2 days after first exposure
inmates without “valid” contacts
no negative test for PCR +/- 2 days of first exposure
no follow-up testing data
could have been exposed to >1 infected case
After Exclusions, the Study Used Only 0.79% of the Data
Starting with over 155,000 inmates, the study was based on a grand final total of 273 unvaccinated + 953 “vaccinated” = 1,226 inmates. “Vaccinated”, of course, was restricted to inmates only after 14 days after their first dose; anyone who developed COVID-19 or who died on days 1-14 after injection was excluded.
The study is relevant for 0.79% of the inmate population and is not expected to be relevant for 99.21% of the prison population in California. Thus, the PR score of F-.
Even after all of this, the initial (unadjusted) results were reported as
“Unvaccinated index cases had a 36% (31–42%) risk of transmitting to close contacts, whereas vaccinated index cases had a 28% (25–31%)”
In other words, the 95% confidence intervals overlapped (31/31). No difference. Fine.
Side note: I have dealt with the issue of adjusting for covariates as confounders – over-adjusting – before, way back on Sept 28, 2015, when I first started reading en masse all of the studies on vaccine safety I could find:
Not to worry – the authors are just warming up. Adjustments await the reader of the Nature study:
“Adjusting for the duration of exposure between index cases and close contacts, close contacts’ history of vaccination and prior infection, facility effects, and background SARS-CoV-2 incidence via a robust Poisson regression model, we estimated that index cases who had received ≥1 COVID-19 vaccine doses had a 22% (6–36%) lower risk of transmitting infection than unvaccinated index cases.”
Now, if you can divine what “facility effects” are from the information provided (I could not), and if you think the duration of exposure does not matter necessarily must be precisely the same between vaccinated and unvaccinated (I do not), and if you believe that the immunity of inmates’ close contact does not matter (it does), you can just use this handy percentage (22%)– and that is the percentage that is being used to claim that the vaccine works.
And of course, that is how the study is being interpreted. It is being misinterpreted as if it provides definitive proof that vaccination reduces transmission (in general) – as if the association can test the hypothesis of causality (it cannot).
But that inference should strictly be limited to assessing the risk of infection in people who have two doses, and then only 14 days after the second dose, or more specifically, inmates who are housed in close quarters with other inmates, and who also meet the exclusion criteria, and is relevant to 0.79% of the inmate population.
And because of the artificiality of the setting, sampling bias of the inmates, and peculiarities of their make-up and their behavior, It is not likely relevant to the general population.
Neil de Grasse Tyson and Bill Maher both said recently that differences between populations differ, Tyson, arm-waving and high-voicing yelping (about how correct he is) tried to use population differences to try to downplay the importance of the miracle of Sweden (as if parts of the United States do not have the same population density!), to which Maher correctly adjusted:
“You just said that we can’t make any judgment (on whether the lesson of Sweden shows our response was wrong) because don’t live in another universe where the United States handled it differently, and I’m saying there are other places that did handle it differently – and that does matter.”
Good for Maher.
The problem for the WHO, CDC, FDA, NIAID, Fauci, and people who message and think like these organizations is this: you cannot debunk reality.
Yes, Sweden matters. The data show that Sweden is doing far better than the United States, and is suffering far as a result of their response. And using inmates, Tyson, as if they are representative of the rest of the US population – well, he should be just as excited about that issue as he is about debunking the reality of Sweden.
________________
**Comment**
Researchers beware. The public is on to you. You can fool some of the people some of the time but you can’t fool all of the people all of the time.
A new report reveals that Moderna neglected to share damning data about its new booster. Even FDA vaccine advisory committee member Dr. Paul Offit is rattled:
“did shake my faith. It shook my faith in how these decisions were being made.” ~ Dr. Paul Offit
And that, my friends, is the closest thing to an apology you are ever gonna get.
“The experience of the past year has taught us that chasing these Omicron variants with a bivalent vaccine is a losing game,” ~ Dr. Paul Offit, director of the vaccine education center at the Children’s Hospital of Philadelphia
Offit says it’s time to rethink booster recommendations in a perspective published Jan. 11 in the New England Journal of Medicine. He states most have been infected, “vaccinated,” or both and that the latest data show the newest booster isn’t that much more effective in generating antibodies than the original vaccine when used as a booster.
Yet the narrative continues despite the avalanche of truth that continues to fall.
The reason for the walk-back by public health ‘authorities?’ Could it be due to more and more research showing the clot shot does not work but actually gives you a higher risk for infection and has the potential to kill you? Then there’s Japan – in a league of its own due to being more boosted than other countries, yet suffering from excess death and itshighest ever daily COVID death tollin the booster era of early 2022. (Japan continues to count anyone who dies with a positive test, a COVID death regardless of the actual cause)
It’s going to become harder and harder to hide from this. Perhaps corrupt public health ‘authorities’ realize that ‘if you can’t beat them, join them?’
Tormented by severe facial pain, Hugh Spencer invented a nonsurgical way to relieve his trigeminal neuralgia. He found the remedy—capsaicin—inside a canister of pepper spray.
Nineteen years ago, in a distant corner of northeast Australia, a scientist named Hugh Spencer started suffering horrible attacks of pain on the left side of his head. It felt as if someone were striking him with an axe. A neurobiologist by training, Spencer—in his 50s at the time—feared that he was experiencing the first foreboding glimmers of an agonizing ailment called trigeminal neuralgia.
It’s a neurological disorder that happens when the trigeminal nerve—a major cranial nerve that affects facial sensations and chewing—goes haywire, often for unknown reasons. It then floods the spinal cord and brain with ferocious pain signals. Typically described as electrical or stabbing, the facial pain can be so unbearable that trigeminal neuralgia has been dubbed “the suicide disease.” And indeed, Spencer—unable to control his escalating pain with medications alone—eventually found himself nearly pushed to the brink.
If his medical ordeal weren’t challenging enough, he also had to deal with one other obstacle: geographic remoteness rivaling that of Gilligan’s Island. Spencer runs an environmental research station at Cape Tribulation. There, scientists from around the world study everything from flying foxes to invasive weed species. Located along a coastline teeming with crocodiles, pythons, and ostrichlike cassowaries, his research station is actually closer to Papua New Guinea than to any major city in Australia. In fact, his nearest neighbor is the oldest tropical rainforest on earth.
When you’re that far off the beaten track, you’re forced to be self-reliant. So Spencer got to work. And through some daunting experiments in which he cast himself in the role of guinea pig, he came up with his own treatment for trigeminal neuralgia that permanently eliminated his pain. What’s more, his treatment is low-tech. It’s low-cost. It’s do-it-yourself. And anatomically, it makes sense, though it hasn’t gone through clinical trials.Hundreds of people with trigeminal neuralgia have now tried his method, and for about half of them, says Spencer, it’s worked. And it involves no pharmaceuticals, no surgery, and—he insists—no long-term side effects.
Conventional treatments for trigeminal neuralgia can’t make that same claim. The problem with medications, aside from possible side effects, is that they may fail to prevent the pain from intensifying over time. And various surgical procedures don’t always work but can lead to scary complications. For example, microvascular decompression surgery (MVD)—a type of brain surgery—is designed to relieve the pain without harming the trigeminal nerve. But here’s the bad news: the procedure involves cutting open the skull and tinkering with what’s inside, which poses a risk of complications, including hearing loss, cerebrospinal-fluid leakage, stroke, and even death.
By contrast, other less-invasive surgical options intentionally damage the trigeminal nerve in hopes of disrupting its ability to transmit pain signals. For example, radiosurgery (a.k.a. Gamma Knife or CyberKnife) uses radiation to do it. Balloon compression rhizotomy uses pressure. Glycerol injection uses a corrosive chemical. And radiofrequency thermal lesioning uses heat.
The problem is, the trigeminal nerve doesn’t just register pain. It also allows you to feel normal facial sensations—everything from the wind on your cheek to a kiss on the lips. So by messing with that nerve, these procedures can sometimes cause troubling facial numbness. What’s more, they aren’t always successful at stopping the pain or preventing it from coming back.
By contrast, Spencer argues that his approach poses no lasting complications. And it uses a chemical so ubiquitous that you probably ate it the last time you dined at a Mexican, Thai, or Indian restaurant. That chemical—called capsaicin—is what gives chili peppers their heat.
For years, a growing body of research has found that capsaicin—when applied topically—can ease certain types of pain, including difficult-to-treat neuropathic pain. But nobody’s used it in the daring way that Spencer advocates for treating trigeminal neuralgia. For starters, he didn’t put the capsaicin on his skin. He put it inside his mouth.
And Spencer didn’t get his first batch of capsaicin from a tangy little jalapeño pepper. He got it from an old canister of pepper spray, like the kind police officers use. Just imagine the burn you’d feel by holding a spoonful of Sriracha sauce in your mouth for 20 minutes. Now multiply that heat by a factor of 300, and you’ll have some inkling of what Spencer’s fiery treatment involves.
But what does superintense spiciness have to do with relieving nerve pain?
Listen to the full podcast interview HERE in which Spencer talks about:
• His desperate battle with trigeminal pain
• Why he refused to consider surgery
• His trial-and-error search for a noninvasive remedy
• The unlikely technique that quickly vanquished his suffering
• The science behind why capsaicin appears uniquely able to reduce facial pain without hindering normal facial sensations
• The reason capsaicin works for some patients but not others
• Why he believes that his approach has important advantages as a first-line treatment over more invasive alternatives.
In this video, Hugh Spencer demonstrates how he used capsaicin to vanquish his trigeminal neuralgia and explains the science behind capsaicin’s ability to dial down the pain:
Straight from the Lab:
What’s the evidence for capsaicin’s ability to relieve trigeminal neuralgia and other types of neuropathic pain? And how effective are conventional treatments? Scientists have been asking those same questions. Explore this sampling of their research to date:
Can’t sleep because of chronic pain? (And wondering if weed might help?) Get David Sharp’s new book, Cannabis Lullaby: A Painsomniac’s Quest for a Good Night’s Sleep. Available in print, ebook, and audiobook, it’s brimming with real-world, evidence-based answers. The author is Painopolis co-host David Sharp, an award-winning health journalist who nipped his pain-fueled insomnia in the bud. Buy a copy today at: painopolis.com/cannabis-lullaby/
This article originally appeared on Painopolis.com and is being reprinted with the permission of its author.
ABOUT THE AUTHOR: David Sharp is an award-winning journalist, author, and podcaster in Portland, Oregon. He’s a co-host and editor of Painopolis, a podcast for people with chronic pain. His career includes 10 years as a contributing editor at Health and Hippocrates magazines. He’s worked on the editorial staffs of Consumer Reports on Health and Health Digest. His articles have appeared in many national publications, including Sports Illustrated, Publishers Weekly, Redbook, Eating Well, Reader’s Digest, and USA Today. He coauthored an earlier book, Six Months Off: How to Plan, Negotiate, & Take the Break You Need Without Burning Bridges or Going Broke. Read more of his blogs at Painopolis.com
Patent royalties and pharmaceutical profits over lifesaving care? (Part 2)
Carl Tuttle
Hudson, NH, United States
JAN 12, 2023 —
We have been shouting from the rooftops for decades!! No one listened.
Now through the current pandemic the rest of the world is waking up to a False Public Health Narrative.
What you are about to read set the stage for “Safe and Effective”
-Manipulated diagnostic tests
-Suppression of the truth, facts, and scientific references
-Persecution of doctors who did not conform to published IDSA treatment protocols
-False Public Health Narrative; “Hard to catch and easy to treat”
After experiencing Covid, Now do you believe us?
Patent royalties and pharmaceutical profits over lifesaving care? Sound familiar?
2nd letter to Dattwyler (See previous update for part1)
——— Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: “Raymond_Dattwyler@nymc.edu” <Raymond_Dattwyler@nymc.edu>
Cc: “npjvaccines@nature.com” <npjvaccines@nature.com>, “abarrett@utmb.edu” <abarrett@utmb.edu>, “R.W.Titball@exeter.ac.uk” <R.W.Titball@exeter.ac.uk>, “mgomesso@uthsc.edu” <mgomesso@uthsc.edu>
Date: 01/11/2023 10:46 AM
Subject: Re: The year that shaped the outcome of the OspA vaccine for human Lyme disease
Dr. Dattwyler
As a follow-up to my inquiry questioning patent royalties and pharmaceutical profits over lifesaving care, you failed to mention in your manuscript that Western blot reporting criteria was manipulated in 1995 to facilitate vaccine development. (Dearborn Conference)
That manipulation led to a reduction in diagnostic success rate to 31% as reported by Dr. Paul Fawcett during the 1995 Rheumatology Symposia:
1995 Rheumatology Symposia Abstract# 1254 Dr. Paul Fawcett et al.
Dr. Fawcett has been the head of the research and clinical immunology laboratories since 1986. In addition, he serves as Chair of the IACUC and is a member of the IRB.
Source: https://www.nemoursresearch.org/snap/node/11969
Even more significant is Dennis Parenti’s 1998vaccine presentation (Lyme.org at 1 hr 9 minutes). Dr. Parenti, medical director of the vaccine trial – the largest Lyme trial in history, discusses the research findings of seronegative Lyme. At 36% it is a common presentation. This proves that a negative western blot is meaningless. Since their patients were culture positive and/or DNA positive for Borrelia infection and western blot negative. Those patients would never get treatment because of the false standard. Despite the CDC knowing this, HHS knowing this, physician harassment continued unabated. This means that our own government was cherry-picking scientific findings to force false science on public health and block the public from getting the medical care they needed.
Once again, patent royalties and pharmaceutical profits over lifesaving care.
Slide from Dennis Parenti’s 1998 vaccine presentation:
See slide here_________________________________________________________
Seronegative Lyme does not prove:
1. A vaccine prevented disease:
2. A patient does not have Lyme disease;
3. Malpractice by doctors who treat them for disease;
4. An antibiotic has eradicated the disease;
5. A relapse is not occurring.
Seronegative Lyme is another clue of how the pathogen disables the patient’s immune system. That is the message by the bacterium to researchers, not that the patient does not have Lyme disease.
“Every research study that uses and article referencing seronegative Lyme to indicate any of the above is fraudulent and should not be used. Almost all protocols ignore this fact!!!” -Karen Vanderhoof-Forschner, Lyme Disease Foundation (founded in 1988)
_______________________________________________
The pursuit of patent royalties and pharmaceutical profits has caused unimaginable pain and suffering all across America!
Carl Tuttle
Hudson, NH
Cc: Alan D.T. Barrett, PhD Editor-in-Chief
Rick Titball, PhD, DSc, Deputy Editor
Willy Burgdorfer
Lyme Disease Foundation
Please share as widely as possible, especially to member of state medical licensing boards and state health departments. Remember, Dave Dennis, the cdc Lyme project officer was allowed to consult $$ directly with SKB. He…
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author, and podcaster in Portland, Oregon. He’s a co-host and editor of 
