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.
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
On December 27, 2022, my colleague and I filed our second Remdesivir Wrongful Death Lawsuit here in the State of Nevada, where we alleged that a Las Vegas hospital and its staff violated Nevada law, medical ethics, acted with negligence, and were motivated by financial incentives in their treatment of patients with COVID-19.
In November of 2020, a Nevada woman developed COVID-19 and was transported to the hospital with mild symptoms. After providing their medical diagnosis, the physicians admitted her to a general medical room and placed her on a Bi-Pap machine to assist with her breathing. Everything was normal for her on November 23. For reasons unknown, those physicians started her on a 4-day course of the deadly drug Remdesivir. (See link for article)
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Summary:
After being stabilized, for reasons unknown, they weaned her off the Bi-Pap machine and moved her into ICU.
Despite being stabilized, physicians intubated her because of ‘respiratory failure.’
Four days after her Remdesivir treatment she developed seizures, went into hypotensive shock with renal failure, and subsequently died.
It is a violation of Nevada law to administer unnecessary medical treatment and without consent
Patients coming to the hospital are:
separated from family
declared to be in ICU even when they are not
told Remdesivir is the only available and safe treatment
told if they leave the hospital “against medical advice” their insurance will be voided
placed on a Bi-Pap machine at a high rate, making it difficult to breathe, and have their hands tied down so they can’t take it off their face
deemed “agitated” by a psychiatrist if they struggle and are placed on morphine
given Remdesivir, Benedryl, and Tylenol which dry out their lungs which overloads their kidneys and are denied food and water
often intubated and placed on other drugs that are contraindicated for use with Remdesivir
left to die, which on average takes about nine days
The state of Nevada received $1 BILLION from the CARES Act
$241 MILLION in direct cash payments were distributed to Medicare providers
$88 MILLION was given in grant funding from CDC to be used for enhanced testing and contact tracing
$70 MILLION was distributed to health care providers and community health services to address costs associated with the pandemic
Hospitals can charge THREE different rates for COVID diagnosed patients (which have varied between 2020-2022)
$3,200 per out patient
$111,213 per in patient (noncomplex)
$461,780 per patient (complex)
All that is required to move a patient from noncomplex to complex is to be intubated or placed in ICU status
Medicare has provided a code that permits a 20% NCTAP bonus, collected on the entire bill, distributed to hospitals who offer Remdesivir as an exclusive option
In some individuals, a Babesia infection can be fatal or cause serious complications in immunocompromised patients. In others, it can be asymptomatic and go unrecognized. In this study, investigators demonstrate how difficult it can be to eradicate Babesia.
The 74-year-old patient was admitted to the hospital in August 2021 with a 2-day history of fatigue and fevers. She was immunocompromised and had a history of diffuse large B-cell lymphoma treated with chemotherapy, polymyalgia rheumatica treated with low dose steroids (prednisone 5 mg/day, plus a short trial of a tocilizumab [a disease-modifying antirheumatic drug]), and cold autoimmune hemolytic anemia.
“A peripheral blood smear was positive for B. microti (0.2% parasitemia),” according to the authors. Her Hgb dropped as low as 6.5 g/dl. She received 10 units of blood.
She was initially treated with a 7-day course of azithromycin and atovaquone. She was also prescribed steroids. Her parasitemia resolved.
However, the woman developed recurrent fatigue and fever with a recurrence of parasitemia (0.3%).
The clinician planned to retreat her with a 6-week course of azithromycin and atovaquone, but added clindamycin due to a persistent parasitemia and fatigue. She was subsequently switched to quinine plus oral clindamycin.
“This antiparasitic drug regimen was discontinued on 20 January 2022, because she developed symptoms consistent with cinchonism (hearing loss, vertigo, tinnitus),” wrote the authors.
Cinchonism resolved after stopping her quinine plus oral clindamycin.
“She then developed severe fatigue and subjective fevers on 22 February 2022 with a recurrence of the babesia parasitemia (<0.1%), along with evidence of worsening hemolysis,” wrote the authors.
She was retreated with oral clindamycin along with a reduced dose of quinine. Her parasitemia continued.
The woman was then prescribed off label tafenoquine, as she tested negative for glucose-6-phospate dehydrogenase deficiency.
“She was started on oral tafenoquine 200 mg once a day for 3 days (loading dose) from 7-9 March 2022, and then 200 mg once per week thereafter starting on 16 March 2022,” wrote the authors. The Hgb rose from 6.5 g/dl to 13.3 g/dL without transfusions.
Tafenoquine was stopped after 6 weeks due to neutropenia. “The neutrophil count reached a nadir level of 325 cells/uL,” wrote the authors.
The woman’s severe fatigue, parasitemia (<0.1%), and hemolysis recurred.
“She was started on a new drug regimen of oral azithromycin 1000 mg once daily, atovaquone liquid suspension 750 mg once daily, and four Malarone® tablets once daily (each tablet consisting of 250 mg atovaquone plus 100 mg of proguanil) on 2 June 2022,” wrote the authors.
By the end of June, PCR testing for Babesia was negative.
However, “It was planned to continue treatment for at least 12 weeks,” wrote the authors, “and even to consider chronic suppressive therapy going forward.”
Prasad et al. described two previous cases where tafenoquine was effective for Babesia.
The authors concluded:
“Therefore, based on available data, tafenoquine as a single agent may, or may not, be curative of B. microti infection in a chronically immunocompromised patient.”
“Clearly, more clinical studies and more studies conducted in animal models are needed to optimize the use of tafenoquine in order to prevent a relapse of B. microti infection in chronically immunocompromised patients with babesiosis when the drug is discontinued.”
References:
Prasad, P.J. and G.P. Wormser, Failure of an Approximately Six Week Course of Tafenoquine to Completely Eradicate Babesia microti Infection in an Immunocompromised Patient. Pathogens, 2022. 11(9).
What’s preventing your recovery from Lyme disease?
By Todd Maderis, ND
Jan. 3, 2023
As we begin a new year, I have spent time reflecting on what is preventing many people with complex chronic illnesses, including Lyme disease, from getting better.
If you’re one of the many people struggling to recover from chronic illness, I offer some thoughts for your consideration.
So, what is preventing people with chronic illnesses from getting better?
Access to physicians with experience treating Lyme disease
According to LymeDisease.org’s patient-driven research platform, MyLymeData, a significant obstacle to an accurate diagnosis is patient access to care by a healthcare provider experienced in Lyme disease and associated infections.
Almost 50% of respondents in the MyLymeData registry reported they saw over seven physicians before being diagnosed with Lyme disease. Treatments for Lyme disease are more effective the earlier they are implemented. Unfortunately, for 73% of respondents, it took over a year for a correct diagnosis.
In a MyLymeData survey of Lyme-treating doctors, physicians report the top three reasons patients receive a delayed diagnosis of Lyme disease are inadequate physician education about tick-borne diseases, false-negative lab results, and a prior misdiagnosis.
Barriers that contribute to a delayed or accurate diagnosis include poor insurance coverage for Lyme disease, healthcare costs, and a limited number of healthcare providers that diagnose and treat persistent Lyme disease.
As cases of Lyme disease rise in the United States and research studies demonstrate a clear need for improved diagnostics and treatment, we will likely see increased recognition and awareness by healthcare agencies and improved insurance coverage.
Where do people with chronic illnesses turn when they don’t have access to quality care?
When people do not have access to a physician experienced in treating Lyme disease, they often turn to online patient support groups for guidance. While these groups can be valuable sources of information and provide emotional support, the suggestions offered by one person may not be what is best for another.
Has the person seeking help been adequately tested for Lyme disease and all associated infections by a reputable tick-borne infection testing laboratory? Do they have additional variables undermining their health, such as high environmental toxin levels or immune system dysregulation, that must be addressed? What is the correct order of treatment?
Physicians treating complex chronic illnesses are challenged to identify all the possible underlying causes of a patient’s symptoms and implement effective treatment strategies. It would be difficult for a member of a support group who is not a physician to know what is best for another person.
Obtaining an accurate diagnosis
If you do not have a map, how do you get to where you want to go? Recovering from illness works the same way. An effective treatment strategy is only as good as the accuracy of the diagnosis. Nuances associated with Lyme disease lab tests create a challenge to getting an accurate diagnosis.
I only rely on reputable Lyme specialty laboratories to make a diagnosis. Testing for chronic viral infections, mold illness, heavy metal toxicity, digestive disorders, and more presents the same obstacle.
Conventional labs like LabCorp and Quest are fine for general markers like blood counts, chemistry panels, and thyroid hormones, but specialized labs need to be used for all the conditions mentioned above. Even within specialized laboratories, some provide more accurate data than others.
The labs that provide me (and my patients) with the best “map” change over time based on advances in testing and my clinical observations. If you tested for tick-borne infections or the above conditions over a year ago, the tests should be repeated because testing has improved. It’s essential to know the current status of the results.
Receiving effective treatments
If you have access to care from a physician experienced in treating Lyme disease and have identified all the underlying causes(s) of your symptoms, the next hurdle is employing effective treatments.
With correct diagnoses, the therapies need to be specific and intentional. Patients tell me they have been prescribed successive treatments for a diagnosis when each treatment did not work. This is like throwing the proverbial spaghetti at the wall and hoping it sticks. Of course, identifying efficacious therapies is challenging, but having a clear direction and using proven treatments is an effective strategy.
Losing hope of healing
People lose hope they will recover from their illness the longer they remain sick. It is disheartening to see patients feeling hopeless because they have been sick for years, have seen many doctors, and have tried dozens of treatments. Hopelessness results from one (or more) of the above reasons.
Some patients I see are mentally unable to move forward once they have an accurate diagnosis and access to effective treatments. It could be that they don’t believe they will ever recover because they have been down multiple dead-end roads of treatment. Some people are traumatized by their illness and have fear or anxiety about an adverse reaction to another treatment. Others do not have the support of their family or partners, possibly due to the invisible illness that is Lyme disease. As the saying goes, “if nothing changes, nothing changes.”
As we begin a new year, I encourage you to reflect upon your health to consider what prevents you from fully recovering from your chronic illness. The general challenges I outlined can serve as an algorithm to help you identify the obstacles to healing so you can take action that moves you closer to optimal health.
Dr. Todd Maderis is Founder and Medical Director of Marin Natural Medicine Clinic in Larkspur, CA. He blogs at DrToddMaderis.com.
author, and podcaster in Portland, Oregon. He’s a co-host and editor of 
