Archive for the ‘Treatment’ Category

Tafenoquine For Relapsing Babesiosis

https://www.sciencedirect.com/science/article/pii/S2214250922000889?via%3Dihub

Use of tafenoquine to treat a patient with relapsing babesiosis with clinical and molecular evidence of resistance to azithromycin and atovaquone

Luis A.Marcosa AnnieLeungb LauraKirkmanb Gary P.Wormserc

https://doi.org/10.1016/j.idcr.2022.e01460Get rights and content
Under a Creative Commons license
Open access

Does Lyme Impair Memory? 6 Restorative Solutions to Help Get Your Brain Back on Track

https://rawlsmd.com/health-articles/does-lyme-impair-memory-6-restorative-solutions-to-help-get-your-brain-back-on-track

Does Lyme Impair Memory? 6 Restorative Solutions to Help Get Your Brain Back on Track

by Jenny Menzel
Updated 3/3/22

Have you ever walked into a room and forgotten the very reason you went there in the first place? Or, how about searching high and low for your missing glasses, only to discover they’ve been on top of your head the whole time? We’ve all experienced brief moments of forgetfulness once in a while, and mostly, they can be humorous. But if you’re struggling with neurological manifestations of Lyme disease, memory issues may be a daily, discouraging occurrence — and that’s no laughing matter.

So why do memory issues and chronic Lyme disease go hand in hand? And more importantly, what does this mean for the health of your brain and its capacity to store and recall information over time? Let’s take a closer look at the reasons why your memory may not be operating optimally, plus natural solutions to restore its function.

Neurological Lyme: A Recap

Neurological Lyme is a different flavor of Lyme disease that occurs when infection with the bacteria Borrelia burgdorferi affects the cranial or peripheral nerves or the central nervous system (CNS), reports the Centers for Disease Control and Prevention (CDC).

In other words, when a Lyme infection triggers an immune response, the immune system rallies white blood cells (WBCs) to act in defense, and inflammatory cytokine activity increases in the brain and spinal cord. When these immune cells infiltrate the CNS in response to a chronic infection, a range of noticeable neurological symptoms may result, such as:

  • Memory loss
  • Cognitive issues
  • Learning disabilities
  • Headaches
  • Bell’s palsy (facial paralysis)
  • Meningitis
  • Numbness and tingling in the extremities
  • Visual impairment
  • Brain fog
  • Depression, anxiety, and other mental health conditions
    Sensation changes on the skin

Not everyone with Lyme disease will experience neurological symptoms, though. When it comes to newly-diagnosed, acute infections, approximately 15% of patients reportedly experience one or more neurological effects like Bell’s palsy, meningitis, or numbness and tingling in the arms or legs, according to research published by Frontiers in Neurology. But this figure may be just the tip of the iceberg.

For a host of reasons, getting an accurate diagnosis and obtaining treatment for Lyme is often delayed (sometimes for months to years) due to a lack of physician understanding and public awareness, an unseen tick bite, the absence of the hallmark erythema migrans (bull’s-eye rash), and insensitive testing methods that produce false negatives.

This delay in diagnosis and adequate treatment allows the bacteria to flourish unchecked, embedding itself deeper into hard-to-reach areas of the body, like the brain — increasing the likelihood of developing difficult-to-eradicate chronic neurological symptoms.

Much Like Our Brains, Neurological Lyme is Complicated

The widespread idea that Lyme disease is easily cured with a 10- to 14-day course of antibiotics persists within most corners of mainstream medicine today. But there is a growing body of evidence to suggest the contrary: For example, in 2013, the International Journal of General Medicine published findings that the Lyme spirochete Borrelia is stealthy enough to evade immune detection and even survive attacks from antibiotics.

split image between borrelia and piles of drug capsules

Anyone experienced with this illness knows, too, that Lyme disease is so much more than a single microbe. With multiple strains of Borrelia in the mix and other common tick-borne coinfections like Bartonella, Babesia, Ehrlichia, and Mycoplasma, understanding the full effects of neurological Lyme is truly complex. However, thanks to the ongoing work of independent researchers and scientists, our understanding continues to unfold and offer helpful clues to the challenging neurological symptoms that so many people deal with.

The Impact of Neurological Lyme on Memory

On average, your brain has 86 billion neurons, each sending out numerous signals from head to toe at breakneck speed to process and store information, control movement and balance, and utilize your five senses, among other crucial tasks. Neurological Lyme can directly impact those functions, including memory, and here’s how.

How Memories are Formed

The study of human memory stretches as far back as 2,000 years to the times of Aristotle, with the first scientific approach introduced in the mid-1880’s by German philosopher Herman Ebbinghaus — the man responsible for classifying the memory types still relevant today. He discovered we actually have three different memory types, giving valuable insight into how the brain works:

  1. Sensory Memory (SM): Formed by how we see, hear, touch, smell, and taste things, SM allows you to remember by stimulating your five senses. After the stimulation, the sensing is assigned to short-term or long-term memory. Smelling your favorite food cooking, hearing a dog bark in the distance, or feeling the texture of wet grass beneath your feet after a spring rain are examples of sensory stimulation we attach to our short-term and long-term memory.
  2. Short-Term Memory (STM): Less fleeting than sensory memory and less permanent than long-term memory, STM helps you recall specific information about anything for just a brief period. Where you park your car at a shopping center is considered a STM due to the “short-term” need to retain the information. STM will get you to your car after you exit the store, but if there is no need to save the information to long-term memory, the memory quickly fades.
  3. Long Term Memory (LTM): There are two types of LTM: explicit and implicit. Explicit LTM is when we consciously and deliberately try to memorize something, like someone’s birthday, phone number, or lyrics to a new song. Implicit LTM is what we remember unconsciously by repetition without even trying, like riding a bike or taking a specific route to work. Any memory we can recall after 30 seconds is considered “long-term,” which is a majority of our memories.

Our memories form in three distinct stages— encoding, storage, and recall. Encoding is how the information gets into your brain, usually through one or more of the five senses. Storage is when that incoming information is briefly stored into STM, or more permanently, into LTM. The final stage is recall, how we retrieve the information after it’s stored.

When stealth microbes like Borrelia make their way to the CNS, they become savage disruptors, creating a breakdown of communication across multiple body systems by damaging nerve cells, kicking up inflammation, and disorganizing neurotransmitters and hormones, thereby instigating memory problems over time. Here are some of the top known ways neurological Lyme impedes your memory.

Neuroinflammation in the Brain

A recent study probing the brains of Lyme patients with chronic symptoms showed the presence of high levels of a substance called inflammatory translocator protein (TSPO), an inflammatory chemical released by two specific types of brain immune cells.

What does this mean for your memory? High levels of neuroinflammatory chemicals may decrease brain function, manifesting in such problems as brain fog and memory loss. Though the study was small-scale, it demonstrates a physiological basis for cognitive problems and validates the experience of countless people living with Lyme.

graphic of brain producing static electricity

Demyelination of Nerves

Much like electrical wires require insulation to keep the electrical current contained, the nerves in our brains are protected with an outer sheath called myelin, which protects nerves for other electrical impulses. Because microbes like Borrelia and Mycoplasma consider myelin a high-value resource to snack on, people with neurological Lyme are vulnerable to demyelination — deterioration of the nerve coating. When this happens, raw nerves are eventually exposed, and signaling between the nerves diminishes, resulting in communication breakdown. Demyelination caused by Lyme disease has been documented as early as 1989, suggesting the probability of CNS involvement, even after the initial infection appeared to be resolved.

Possible Dementia Connection

Although some studies have suggested dementia-like syndromes may exist as rare manifestations of neurological Lyme, recent research points to a more direct connection. Findings in Frontiers in Neurology support the possibility that neurological Lyme might be linked to Lewy body dementia, a condition where abnormal protein deposits to the nerve cells in the brain cause severely impaired reasoning, mood changes, and memory loss.

While there’s still a lot to learn about this manifestation, this is the first time a persistent neurological Lyme infection has been directly linked to the presence of dementia-inducing antibodies.

6 Effective Solutions to Restore Your Memory

Unfortunately, the current CDC treatment guidelines for neurological Lyme are antibiotics that are often ineffective in later stages of the illness, but all hope is not lost. If you’re experiencing Lyme-related memory problems, there are lifestyle habits and natural remedies like herbs that can help normalize disrupted communications in the brain and nervous system and enhance your memory. Here’s how.

icon of fish, chicken, and eggs

1. Eat Brain Food.

Nourishing your body with a balanced, anti-inflammatory diet rich in vegetables, healthy omega-3 fats, and choline-dense protein like poultry, fish, and eggs is one of the best ways to begin nourishing a vibrant memory and curb unwanted inflammation. As for brain fruit, blueberries full of flavonoids top the list. Furthermore, adding anti-inflammatory spices to your food is another way to benefit the brain. Turmeric and saffron win by supporting the vascular system and boosting blood flow to the brain. Fun tip: Have fun trying out new recipes by focusing on one new brain food per week to find your favorites.

icon of puzzle on phone

2. Get Creative with Brain Games.

While cognitive exercise apps such as Elevate or Lumosity are great options to get your brain in shape, don’t discount the power of your mind to make up your own activities. For example, make a game out of everyday events like shopping for groceries. Tally up the prices in your head as you shop, starting with just a few items and working your way up to see if you can calculate the amount you’ll pay at the register. Over time, you’ll sense improvements, and the process will get easier. However, if you prefer a break from the digital realm, classic crossword puzzles are another great (and inexpensive) option to challenge your memory.

icon of headphones

3. Try Interactive Metronome Therapy (IMT).

Take brain games to the next level with Interactive Metronome (IM), a therapy that is used to enhance memory, attention, focus, speech, and sensory skills in those struggling with cognitive impairment from various forms of brain injuries — even those associated with Lyme disease. By resetting your internal brain clock and retraining neural pathways, the therapy improves communication and desensitizes hyperactive areas of the brain while activating the sluggish areas. The brain-balancing exercises are often covered by insurance and can be performed under the supervision of a variety of professional therapists to increase the brain’s ability to record, store, and recall memories.

icon of herbal supplement bottle and capsules

4. Use Brain Supportive Herbs.

Balancing the brain with herbs will naturally boost your memory by creating healthy stress responses and sleep-wake cycles and reducing the microbial load. Some top herbs to suppress infectious microbes, reduce neuroinflammation, and increase needed blood circulation to the brain include:

Need a boost of clean energy in the morning to feel awake and alert? Herbs can help there, too. Try rhodiola or licorice root in the morning to get your day going without caffeine. And for a nightcap to gently unwind, try herbs with balancing and soothing properties like ashwagandha and l-theanine to regulate the HPA-axis and calm the nervous system for better quality sleep.

icon of moon and stars

5. Reduce Excess Brain Stimulation.

We live in a noisy world and are probably the most overloaded with stimuli than ever before in human history, but there are steps you can take to reduce the noise and help you focus. Try setting a specific time to digitally unplug every night, and consider setting your smartphone outside of your bedroom on the charger.

Need your phone for an alarm clock? Set it on airplane mode to avoid distracting notifications — or go minimalist with a simple alarm clock. Additionally, infuse your nightly routine with calming scents like rosemary, frankincense, and lavender. When delivered through the olfactory system, these essential oils can cool an inflamed nervous system, creating a clearer mind able to retain and recall information.

icon of human doing tai chi

6. Cultivate a Mind-Body Connection.

Mind-body practices like hypnosis, yoga, tai-chi, and meditation combine mental and physical focus with breathing and body movements, and scientific evidence supporting their positive effects on the nervous system is growing:

Research published by the Journal of Alzheimer’s found that after only 8 weeks of daily meditation, a small group of participants ages 52 to 77 experienced a significant increase in cerebral blood flow to the frontal and parietal lobes of the brain — two areas responsible for retrieving stored memories. If beginning a mind-body practice has been on your Lyme recovery to-do list for a while, the health of your brain and better memory are two great reasons to get started!

Healing Takes Time

If you’ve been struggling with memory problems from Lyme, you’ve likely come to find that healing is a marathon, not a sprint. Because our brain cells take the longest to repair, improving Lyme-related memory issues isn’t easy, but it’s possible — and worth it.

To sharpen your memory, combine these tips with the essentials, like a comprehensive natural protocol to suppress microbes, a reparative sleep schedule, and exercise as tolerated. If you remember nothing else, remember to keep it simple, pace yourself, and (gently) keep going.

REFERENCES
1. Berndtson K. Review of evidence for immune evasion and persistent infection in lyme disease. International Journal of General Medicine. 2013:291. doi: 10.2147/ijgm.s44114
2. Blanc F, Philippi N, Cretin B, et al. Lyme neuroborreliosis and dementia. J Alzheimers Dis. 2014;41(4):1087-1093. doi: 10.3233/JAD-130446
3. Bloomfield MA, Green SF, Hindocha C, et al. The effects of acute cannabidiol on cerebral blood flow and its relationship to memory: An arterial spin labeling magnetic resonance imaging study. Journal of Psychopharmacology. 2020;34(9):981-989. doi: 10.1177/0269881120936419
4. Chianese R, Coccurello R, Viggiano A, et al. Impact of Dietary Fats on Brain Functions. Curr Neuropharmacol. 2018;16(7):1059-1085. doi: 10.2174/1570159X15666171017102547
5. Ebbinghaus H. Memory: a contribution to experimental psychology. Ann Neurosci. 2013;20(4):155-156. doi: 10.5214/ans.0972.7531.200408
6. Gadila SKG, Rosoklija G, Dwork AJ, Fallon BA, Embers ME. Detecting Borrelia Spirochetes: A Case Study With Validation Among Autopsy Specimens. Front Neurol. 2021 May 10;12:628045. doi: 10.3389/fneur.2021.628045
7. Hein S, Whyte AR, Wood E, Rodriguez-Mateos A, Williams CM. Systematic Review of the Effects of Blueberry on Cognitive Performance as We Age. J Gerontol A Biol Sci Med Sci. 2019;74(7):984-995. doi: 10.1093/gerona/glz082
8. Herculano-Houzel S. The human brain in numbers: a linearly scaled-up primate brain. Front Hum Neurosci. 2009 Nov 9;3:31. doi: 10.3389/neuro.09.031.2009
9. Khalsa DS. Stress, Meditation, and Alzheimer’s Disease Prevention: Where The Evidence Stands. J Alzheimers Dis. 2015;48(1):1-12. doi: 10.3233/JAD-142766
10. Kristoferitsch W, Aboulenein-Djamshidian F, Jecel J, et al. Secondary dementia due to lyme neuroborreliosis. Wiener klinische Wochenschrift. 2018;130(15-16):468-478. doi: 10.1007/s00508-018-1361-9
11. Neurologic Lyme Disease. Centers for Disease Control and Prevention. Website. Published August 11, 2021. Accessed February 27, 2022.
12. New Scan Technique reveals brain inflammation associated with post-treatment lyme disease syndrome. Johns Hopkins Medicine Newsroom. Website. Published February 5, 2019. Accessed February 27, 2022.
13. Pachner AR, Duray P, Steere AC. Central nervous system manifestations of lyme disease. Archives of Neurology. 1989;46(7):790-795. doi: 10.1001/archneur.1989.00520430086023
14. Pragya SU, Mehta ND, Abomoelak B, et al. Effects of Combining Meditation Techniques on Short-Term Memory, Attention, and Affect in Healthy College Students. Front Psychol. 2021;12:607573. Published 2021 Mar 5. doi: 10.3389/fpsyg.2021.607573
15. The science behind IM. Interactive Metronome. Website. Published July 21, 2020. Accessed February 27, 2022.

Dr. Monica Embers: An Overview of Lyme & Tissue Research

http://  Approx. 42 min

Dr. Monica Embers: An Overview of Lyme & Tissue Research

Dr. Monica Embers is an Associate Professor of Microbiology and Immunology and Director of Vector-Borne Disease Research at the Tulane University National Primate Research Center. Dr. Embers studies Borrelia burgdorferi – the bacterial pathogen that causes Lyme disease. Her work focuses on use of well-established animal models to study Borrelia persistence in tissue and antibiotic efficacy against Lyme disease. She is also working on projects aimed at developing novel therapeutic strategies to eradicate Borrelia infection.

For more:

WSJ & NY Times Mislead Public on New Ivermectin Study

https://childrenshealthdefense.org/defender/wsj-misleads-public-ivermectin

WSJ Misleads Public on Ivermectin, Ignores Latest Revelations About ‘Hidden Author’ Who Undermined Its Efficacy

The Wall Street Journal this month published an article citing a flawed, unpublished study concluding ivermectin didn’t reduce COVID-19 hospitalizations. Meanwhile, the paper ignored news earlier this month that a documentary producer discovered the individual likely responsible for tanking a key, systematic review showing how ivermectin could have saved millions of lives.

Editor’s note: The Wall Street Journal isn’t the only top-tier news site that misled the public on the New England Journal of Medicine study published Wednesday. The New York Times also failed to provide a critical analysis of the study.

New revelations surfaced this month around the suppression of ivermectin as a treatment for COVID-19.

The Frontline Covid-19 Critical Care Alliance (FLCCC) Community on March 8 lauded  Phil Harper, a documentary director and producer, for his efforts to identify the unnamed individual responsible for influencing leading expert opinion on the safety and efficacy of ivermectin in treating COVID early in 2021.

The actions of this hidden hand resulted in the systematic and tragic dismissal of a powerful remedy that could have saved millions of lives across the world.

Before we dig deeper into Harper’s discovery, let’s look at the latest attempt by a mainstream media outlet to discredit ivermectin’s utility in treating COVID

The Wall Street Journal misleads the public

The Wall Street Journal on March 18 published an article with this headline: “Ivermectin Didn’t Reduce Covid-19 Hospitalizations in Largest Trial to Date.”

Headline readers will easily reach the seemingly obvious conclusion: Drs. Anthony Fauci and Rochelle Walensky, along with the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention, were right all along.

However, for those who read beyond the headline and first few paragraphs, the story begins to morph.

The headline clearly states the trial in question was the largest to date. However, this is not the case — as the article’s author, Sarah Toy, explains early in the piece:

“The latest trial, of nearly 1,400 Covid-19 patients at risk of severe disease, is the largest to show that those who received ivermectin as a treatment didn’t fare better than those who received a placebo.”

This wasn’t the largest trial to date — it was only the largest trial to date among the subset of trials that have shown no benefit of ivermectin.

Was this an oversight? Or was it a deliberate attempt to confuse the 42 million readers of The Wall Street Journal’s digital content?

Putting aside the possible intention to mislead, it is impossible for a study to definitively prove that no effect exists. This is what is referred to in science as the null hypothesis, meaning an intervention has no effect.

It is entirely possible that a study may demonstrate no measurable effect. It is quite a different thing to prove that that same intervention will not have an effect under any circumstances.

To put it flatly, one cannot prove that something doesn’t exist.

Toy chose not to mention the 81 separate studies — involving a combined 128,000 participants — that demonstrated an average efficacy of 65% for several different outcomes.

She also did not mention the 22 studies — involving nearly 40,000 people — around the outcome in question, hospitalization. Those studies showed an average efficacy of 39%.

The Wall Street Journal did not cite the study that was the focus of its article, because the study hasn’t yet been published. Yet Toy assured readers the study has been “accepted for publication in a major peer-reviewed medical journal.”

With no paper to cite, the journal instead quoted Edward Mills, one of the study’s lead researchers and a professor of health sciences at Canada’s McMaster University in Hamilton, Ontario:

“There was no indication that ivermectin is clinically useful.”

Of note, all participants in this prospective study were drawn from one of 12 clinics in the Minas Gerais region of Brazil. All were at risk for severe disease due to underlying comorbidities.

The dosing regimen was unspecified and COVID diagnosis was made through rapid testing only.

The real story behind ivermectin and COVID-19

The Wall Street Journal article is yet another widely read piece that cherry-picks studies that purportedly show no benefit while categorically ignoring the mounting evidence to the contrary.

The systematic suppression of ivermectin’s efficacy against COVID has been well documented by The Defender here, and in Robert F. Kennedy, Jr.’s New York Times bestselling book, “The Real Anthony Fauci.”

However, as mentioned at the outset of this article, FLCCC this month shed more light on the mystery behind Dr. Andrew Hill’s stunning decision early in 2021 to recommend that more research would be required to support the use of ivermectin to treat COVID patients — despite the enormous amount of data suggesting otherwise.

It was Hill’s so-called systematic review that effectively scuttled the World Health Organization’s (WHO) acceptance of ivermectin as a potent COVID remedy.

Other governing medical bodies, including the NIH, the U.S. Food and Drug Administration and the UK’s Medicines and Healthcare products Regulatory Agency immediately fell in line behind the WHO’s stance.

Hill had been a strong advocate for ivermectin in the closing months of 2020. In October 2020, he was tasked by the WHO to present the findings on ivermectin.

Hill, Dr. Tess Lawrie, director of The Evidence-Based Medicine Consultancy, Ltd. and other researchers were collaborating to publish their findings in early 2021. Those findings would definitively conclude that ivermectin could and should be used to treat COVID at all stages of the disease.

On Jan. 18, 2021, days before the planned publication of this joint effort, Hill chose to independently release his findings on preprint servers. He concluded the opposite of what he and others had found through their research:

“Ivermectin should be validated in larger appropriately controlled randomized trials before the results are sufficient for review by regulatory authorities.”

His shocking reversal of opinion drew immediate consternation from members of FLCCC and Lawrie. Soon after Hill released his paper, he spoke with Lawrie in a recorded zoom meeting that raised more questions.

Oracle Films released an informative and succinct video that contextualizes the pivotal conversation between Hill and Lawrie.

When Lawrie confronted a squirming Hill, Hill eventually admitted the conclusions in his analysis had been influenced by Unitaid, a quasi-governmental advocacy organization funded by the Bill & Melinda Gates Foundation and several countries — France, the UK, Norway, Brazil, Spain, the Republic of Korea and Chile — to lobby governments to finance the purchase of medicines from pharmaceutical multinationals for distribution to the African poor.

As Kennedy, chairman and chief legal counsel for Children’s Health Defense, writes in his book:

Unitaid gave $40 million to Andrew Hill’s employer, the University of Liverpool, four days before the publication of Hill’s study. Hill, a Ph.D., confessed that the sponsors were pressuring him to influence his conclusion.

“When Dr. Lawrie asked who was trying to influence him, Hill said, ‘I mean, I, I think I’m in a very sensitive position here …’”

Who was the Unitaid member who impelled Hill to change his tune?

Thanks to the sleuthing by Phil Harper, producer, director and author of a Substack newsletter under the moniker “The Digger,” we may have an answer.

The hidden hand that muzzled ivermectin

Harper explained his remarkable discovery, writing:

“Sometimes information can be sitting right underneath your nose. Many suspected that ‘persons unknown’ had altered the paper, but we didn’t know who. Who are these people who nudge science into profitable shapes?!”

In another Substack article, Harper explained how he was able to identify crucial changes made in the days prior to the study’s distribution by comparing it to a previous version that was emailed to Lawrie. This original version was not made public.

The changes were subtle but clearly designed to weaken the conclusions of the analysis. Even more suspicious was the deletion of Unitaid’s financial contribution in the form of an “unrestricted research grant” from the funding declaration portion of the paper.

By examining the metadata attached to the PDF document Hill submitted to several preprint servers, Harper discovered that the author (as indicated in the metadata) of the paper was Andrew Owen, a professor of pharmacology & therapeutics and co-director of the Centre of Excellence in Long-acting Therapeutics (CELT) at the University of Liverpool.

Harper continues:

“His authorship is tied programmatically to the document, meaning a device or software programme registered to the name Andrew Owen saved off the document as a PDF.  When exporting a PDF, Microsoft Word automatically adds title and author information.

“Unless someone used his computer, Andrew Owen has his digital fingerprint on the Andrew Hill paper. A paper we have very strong reason to believe was altered by ‘people’ at Unitaid.”

Owen is also a scientific advisor to the WHO’s COVID-19 Guideline Development Group. Just days before Hill’s original paper was to be published, a $40 million grant from Unitaid, the paper’s sponsor, was given to CELT. Owen is the project lead for that grant.

According to Harper:

“The $40 million contract was actually a commercial agreement between Unitaid, the University of Liverpool and Tandem Nano Ltd (a start-up company that commercializes ‘Solid Lipid Nanoparticle’ delivery mechanisms) — for which Andrew Owen is a top shareholder.”

Owen is not listed as an author of the analysis, yet his digital fingerprint is on its last-minute revisions.

Instead, Hill listed all the authors of the studies that his systematic review was critiquing as co-authors of the review itself. This is a striking departure from standards of a systematic review, as it undermines the purpose and objectivity of such an analysis.

Conclusion

It is difficult to summarize this situation without diluting the impact of what has been presented here.

Mainstream media sources such as The Wall Street Journal continue to publish unbalanced and poorly researched articles while enormous stories are unfolding behind the wall of corporate-funded propaganda.

Hill’s own opinion, when untrammeled by hidden influence, suggested 75% of COVID deaths could have been prevented by using ivermectin as treatment.

The “hidden hands” of profit-driven operatives are taking an enormous toll on humanity through their manipulation of public and scientific opinion.

In the end, the public must decide when enough is finally enough.

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.

“© [3/30/22] Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

__________________

https://childrenshealthdefense.org/defender/ny-times-mislead-public-ivermectin-study

NY Times Latest to Mislead Public on New Ivermectin Study

The New York Times on Wednesday sent an email to subscribers titled: “Breaking News: Ivermectin failed as a Covid treatment . . .” The Times was referring to a study in the New England Journal of Medicine, covered March 18 by The Wall Street Journal. In both cases, the newspapers failed to provide an accurate critical analysis of the study.

The New York Times on Wednesday sent an email blast to subscribers with the subject line: “Breaking News: Ivermectin failed as a Covid treatment, a large clinical trial found.”

The Times was referring to a study I wrote about, that same day, for The Defender.

My article called out the Wall Street Journal for its March 18 reporting on the same study — before the study was even published — for its failure to provide an accurate, critical assessment of the study.

The study in question — “Effect of Early Treatment with Ivermectin among Patients with Covid-19” — was officially published Wednesday in the New England Journal of Medicine (NEJM).

In it the authors concluded:

“Treatment with ivermectin did not result in a lower incidence of medical admission to a hospital due to progression of Covid-19 or of prolonged emergency department observation among outpatients with an early diagnosis of Covid-19”

The Times did not critique the study itself, but quoted the opinion of Dr. David Boulware, an infectious-disease expert at the University of Minnesota:

“There’s really no sign of any benefit. Now that people can dive into the details and the data, hopefully that will steer the majority of doctors away from ivermectin towards other therapies.”

Yes. Let us dive into the details and the data and see where it “steers” us, shall we?

A closer look at the details

The NEJM study took place in Brazil between March 23 and Aug. 6, 2021.

The study examined 1,358 people who expressed symptoms of COVID-19 at an outpatient care facility (within seven days of symptom onset), had a positive rapid test for the disease and had at least one of these risk factors for severe disease:

  • Age over 50
  • Hypertension requiring medical therapy
  • Diabetes mellitus
  • Cardiovascular disease
  • Lung disease
  • Smoking
  • Obesity
  • Organ transplantation
  • Chronic kidney disease (stage IV) or receipt of dialysis
  •  Immunosuppressive therapy (receipt of ≥10 mg of prednisone or equivalent daily)
  • Diagnosis of cancer within the previous 6 months
  • Receipt of chemotherapy for cancer.

Young and healthy individuals were not part of this study.

Both vaccinated and unvaccinated individuals were included in the study. The percentage of vaccinated participants in each group was not specified. Note that by choosing not to identify vaccination status as a confounding variable the authors are implying that vaccines are playing no role in preventing hospitalization.

The 1,358 subjects were divided into two equally sized groups that were relatively well-matched and randomized to receive either a three-day dose of placebo or a three-day course of ivermectin at 400 mcg/kg.

The primary outcome was hospitalization due to COVID-19 within 28 days after randomization or an emergency department visit due to clinical worsening of COVID-19 (defined as the participant remaining under observation for >6 hours) within 28 days after randomization.

How researchers were able to conclude ‘no benefit’ despite signs to the contrary

The study’s authors wrote:

“100 patients (14.7%) in the ivermectin group had a primary-outcome event (composite of hospitalization due to the progression of COVID-19 or an emergency department visit of >6 hours that was due to clinical worsening of COVID-19), as compared with 111 (16.3%) in the placebo group (relative risk, 0.90; 95% Bayesian credible interval, 0.70 to 1.16).”

In other words, a greater percentage of placebo recipients required hospitalization or observation in an emergency department than those who received Ivermectin.

The authors of the study broke it down by subgroups here:

As is demonstrated in nearly every subgroup, the Ivermectin recipients fared better than those who received the placebo.

However, these data were not statistically significant given the size of the study.

This is how the authors were able to conclude there was no benefit to ivermectin use in preventing hospitalization in high-risk patients in their study.

Patients were under-dosed, some didn’t follow instructions

As it stands, the study The New York Times and The Wall Street Journal declared as proof of the uselessness of ivermectin in treating COVID-19 is actually quite promising —  contrary to what their headlines told readers.

The dosing protocol advised by the Frontline COVID-19 Critical Care Alliance (FLCCC) includes a five-day course of ivermectin at 600 micrograms per kilogram of body weight for people with risk factors such as those possessed by participants in the study.

Instead, the investigators behind the NEJM study chose a much lower dose, 400mcg per day for only three days. This represents less than half of the total dose that has been shown to be effective in practice.

Furthermore, despite acknowledging that studies have shown some indication that the bioavailability of ivermectin increases when taken with food, especially a fatty meal, participants in the trial were instructed to take the medicine on an empty stomach.

In other words, the patients were significantly under-dosedand yet a positive effect of the drug was emerging, though not statistically significant given the size of the study.

Also of note, the investigators chose to include emergency room visits with hospitalizations for COVID. Clearly, six hours of observation in an ER is a significantly different outcome than a hospitalization that may last a night or much longer.

When excluding the ER visits from the primary outcome and examining only hospitalizations, the ivermectin cohort had even less risk of an outcome, i.e. the relative risk was 0.84 vs 0.9 when ER visits and hospitalization were grouped together.

Perhaps the most glaring deficiency of the study is the low number of placebo recipients who actually followed the study’s protocol:

Only 288 of 679 participants randomized to receiving the placebo reported 100% adherence to the study protocol. Nearly 400 didn’t.

Why not? We asked Dr. Meryl Nass, an internist and member of the Children’s Health Defense scientific advisory committee.

Nass told The Defender:

“Presumably they knew the difference between ivermectin and placebo, and the placebo subjects went out and bought ivermectin or something else … but whatever they did, they didn’t bother with the pills they were given.

“So, it was not actually a double-blinded trial. Yet the 391 people who didn’t take the placebo but did something else were included in two of the three calculations of ivermectin efficacy anyway.”

So, was this the definitive answer proclaimed by mainstream sources? Nass thinks otherwise:

“I would say that instead, it was a failed trial due to the 391 placebo recipients who admitted they did not follow protocol versus the 55 in the ivermectin arm.”

More questions than answers

Rather than pounding the final nail in the coffin around ivermectin’s utility in treating COVID, the NEJM study raises more questions.

  • What would the effect have been if a higher dose shown to be effective were administered?
  • What would be the benefit of this medicine in patients with no risk factors?
  • How statistically significant would the results have been if more participants were enrolled?
  • Why weren’t more participants enrolled as the study progressed given the emerging benefit of the drug and the absence of adverse events?
  • Why did the investigators define a primary outcome with such different real-world implications (ER visits vs hospitalizations)?
  • With less than 50% of the placebo arm adhering to the study protocol, why were their outcomes included in the analysis?
  • What effect did vaccination status have on outcome? If this is the primary means endorsed to prevent hospitalization, why wasn’t vaccination status mentioned as a confounder?
  • Did the investigators choose to limit the study as it became clear that an Ivermectin benefit would be too big to ignore?

Given these obvious issues with the study, it is becoming even more clear where the real story is: Neither The Wall Street Journal or The New York Times are willing to pursue startling details around how corporate interests are corrupting scientific opinion as reported here.

Instead, these iconic journals chose to report on a scientific study on or prior to the day of publication using misleading headlines backed up by flimsy investigations conducted by journalists with no capacity to dissect the analysis or data.

Here’s a bigger question: Are they incompetent, or complicit, too?

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.

“© [3/31/22] Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

For more:

Broken Science Tonight 7:30pm ET & The Illusion of Evidence Based Medicine

https://www.theepochtimes.com/dr-martin-kulldorff-how-to-dismantle-the-cartel-of-public-health-funding-and-rekindle-open-scientific-inquiry  Go here for episode

Dr. Martin Kulldorff: How to Dismantle the ‘Cartel’ of Public Health Funding and Rekindle Open Scientific Inquiry

JAN JEKIELEK

This episode will premiere on Thurs. March 31, at 7:30 p.m. ET.     

New ideas always come from the fringe in science. So we have to encourage new ideas to come up. We can’t have science become a religion where there are dogmas.”

In this episode, filmed at Hillsdale College’s Censorship of Science conference, we sit down with Dr. Martin Kulldorff, an epidemiologist, biostatistician, and former professor of medicine at Harvard Medical School. He’s a co-author of the Great Barrington Declaration that argued for “focused protection” of the vulnerable instead of lockdowns.

Kulldorff breaks down what he sees as the “power hubs” controlling policy, research funding, and career advancement in the scientific world.

“Dr. Fauci sort of sits on the biggest chunk of infectious disease research money in the world. So it takes a bit of guts to contradict his view on pandemic strategy.”

Kulldorff is the scientific director at the Brownstone Institute and a founding fellow at Hillsdale College’s Academy for Science and Freedom.

“I’m very concerned that 400 years of enlightenment or scientific progress may come to an end. And I think we have to work very hard to avoid that.”

For more: 

http://

The Illusion of Evidence Based Medicine

Dr. John Campbell

March 26, 2022

Dr. Campbell goes through a paper that is in the British Medical Journal (BMJ) on how evidence based medicine has been corrupted by corporate interests, failed regulation, and commercialization of academia.

The Research Leader, child psychiatrist Adelaide Leemon B. McHenry, is professor emeritus Emeritus Professor at Cal State University. The research is not commissioned, but is externally peer reviewed & was published on March 16, 2022:  https://www.bmj.com/content/376/bmj.o702

Evidence based medicine has been corrupted by corporate interests, failed regulation, and commercialisation of academia, argue these authors

The advent of evidence based medicine was a paradigm shift intended to provide a solid scientific foundation for medicine. The validity of this new paradigm, however, depends on reliable data from clinical trials, most of which are conducted by the pharmaceutical industry and reported in the names of senior academics. The release into the public domain of previously confidential pharmaceutical industry documents has given the medical community valuable insight into the degree to which industry sponsored clinical trials are misrepresented.1234 Until this problem is corrected, evidence based medicine will remain an illusion.

The philosophy of critical rationalism, advanced by the philosopher Karl Popper, famously advocated for the integrity of science and its role in an open, democratic society. A science of real integrity would be one in which practitioners are careful not to cling to cherished hypotheses and take seriously the outcome of the most stringent experiments.5 This ideal is, however, threatened by corporations, in which financial interests trump the common good. Medicine is largely dominated by a small number of very large pharmaceutical companies that compete for market share, but are effectively united in their efforts to expanding that market. The short term stimulus to biomedical research because of privatisation has been celebrated by free market champions, but the unintended, long term consequences for medicine have been severe. Scientific progress is thwarted by the ownership of data and knowledge because industry suppresses negative trial results, fails to report adverse events, and does not share raw data with the academic research community. Patients die because of the adverse impact of commercial interests on the research agenda, universities, and regulators.

The pharmaceutical industry’s responsibility to its shareholders means that priority must be given to their hierarchical power structures, product loyalty, and public relations propaganda over scientific integrity. Although universities have always been elite institutions prone to influence through endowments, they have long laid claim to being guardians of truth and the moral conscience of society. But in the face of inadequate government funding, they have adopted a neo-liberal market approach, actively seeking pharmaceutical funding on commercial terms. As a result, university departments become instruments of industry: through company control of the research agenda and ghostwriting of medical journal articles and continuing medical education, academics become agents for the promotion of commercial products.6 When scandals involving industry-academe partnership are exposed in the mainstream media, trust in academic institutions is weakened and the vision of an open society is betrayed.

The corporate university also compromises the concept of academic leadership. Deans who reached their leadership positions by virtue of distinguished contributions to their disciplines have in places been replaced with fundraisers and academic managers, who are forced to demonstrate their profitability or show how they can attract corporate sponsors. In medicine, those who succeed in academia are likely to be key opinion leaders (KOLs in marketing parlance), whose careers can be advanced through the opportunities provided by industry. Potential KOLs are selected based on a complex array of profiling activities carried out by companies, for example, physicians are selected based on their influence on prescribing habits of other physicians.7 KOLs are sought out by industry for this influence and for the prestige that their university affiliation brings to the branding of the company’s products. As well paid members of pharmaceutical advisory boards and speakers’ bureaus, KOLs present results of industry trials at medical conferences and in continuing medical education. Instead of acting as independent, disinterested scientists and critically evaluating a drug’s performance, they become what marketing executives refer to as “product champions.”

Ironically, industry sponsored KOLs appear to enjoy many of the advantages of academic freedom, supported as they are by their universities, the industry, and journal editors for expressing their views, even when those views are incongruent with the real evidence. While universities fail to correct misrepresentations of the science from such collaborations, critics of industry face rejections from journals, legal threats, and the potential destruction of their careers.8 This uneven playing field is exactly what concerned Popper when he wrote about suppression and control of the means of science communication.9 The preservation of institutions designed to further scientific objectivity and impartiality (i.e., public laboratories, independent scientific periodicals and congresses) is entirely at the mercy of political and commercial power; vested interest will always override the rationality of evidence.10

Regulators receive funding from industry and use industry funded and performed trials to approve drugs, without in most cases seeing the raw data. What confidence do we have in a system in which drug companies are permitted to “mark their own homework” rather than having their products tested by independent experts as part of a public regulatory system? Unconcerned governments and captured regulators are unlikely to initiate necessary change to remove research from industry altogether and clean up publishing models that depend on reprint revenue, advertising, and sponsorship revenue.

Our proposals for reforms include: liberation of regulators from drug company funding; taxation imposed on pharmaceutical companies to allow public funding of independent trials; and, perhaps most importantly, anonymised individual patient level trial data posted, along with study protocols, on suitably accessible websites so that third parties, self-nominated or commissioned by health technology agencies, could rigorously evaluate the methodology and trial results. With the necessary changes to trial consent forms, participants could require trialists to make the data freely available. The open and transparent publication of data are in keeping with our moral obligation to trial participants—real people who have been involved in risky treatment and have a right to expect that the results of their participation will be used in keeping with principles of scientific rigor. Industry concerns about privacy and intellectual property rights should not hold sway.

Footnotes

  • Competing interests: McHenry and Jureidini are joint authors of The Illusion of Evidence-Based Medicine: Exposing the Crisis of Credibility in Clinical Research (Adelaide: Wakefield Press, 2020). Both authors have been remunerated by Los Angeles law firm, Baum, Hedlund, Aristei and Goldman for a fraction of the work they have done in analysing and critiquing GlaxoSmithKline’s paroxetine Study 329 and Forest Laboratories citalopram Study CIT-MD-18. They have no other competing interests to declare.

  • Provenance and peer review: Not commissioned, externally peer reviewed

References

View Abstract

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**Comment**

Please also read “How Politics Corrupted Evidence-Based Medicine – and How to Fix it” by Dr. Robert Malone.

For more:

In short, science and public health is completely broken, and a powerful unelected ‘Cabal’ controls both scientific funding and health policy in America