Author Archive

Optimizing Exclusion Criteria For Clinical Trials of Persistent Lyme Disease Using Real-World Data

https://www.mdpi.com/2227-9032/13/1/20

Optimizing Exclusion Criteria for Clinical Trials of Persistent Lyme Disease Using Real-World Data

by Lorraine Johnson1, Mira Shapiro2, Deanna Needell3 and Raphael B. Stricker4,*
1LymeDisease.org, Los Angeles, CA 91040, USA
2Analytic Designers LLC, Bethesda, MD 20817, USA
3Department of Mathematics, University of California, Los Angeles, CA 90025, USA
4Union Square Medical Associates, 595 Buckingham Way, Suite 350, San Francisco, CA 94132, USA
*Author to whom correspondence should be addressed.
Healthcare 2025, 13(1), 20; https://doi.org/10.3390/healthcare13010020
Submission received: 15 October 2024 / Revised: 19 December 2024 / Accepted: 21 December 2024 / Published: 25 December 2024
(This article belongs to the Topic Public Health and Healthcare in the Context of Big Data)

Abstract

Background/Objectives: Although eligibility criteria for clinical trials significantly impact study outcomes, these criteria are often established without scientific justification, leading to delayed recruitment, small sample sizes, and limited study generalizability. Persistent Lyme disease (PLD) presents unique challenges due to symptom variability, inconsistent treatment responses, and the lack of reliable biomarkers, underscoring the need for scientifically justified eligibility criteria.
Objective: This study examines the effects of commonly used enrollment criteria on sample yield in PLD clinical trials using real-world data (RWD) from the MyLymeData patient registry. The study also compares the effects of these criteria on enrollment for PLD versus acute Lyme disease (ALD) trials and evaluates the scientific rationale for each criterion.
Methods: Data from 4183 Lyme disease patients enrolled in the MyLymeData registry were analyzed to assess the prevalence and cumulative impact of various criteria on sample yield. A comparative analysis of cohorts with PLD (n = 3589) versus ALD (n = 594) was conducted to identify differences in sample attrition.
Results: In a large PLD cohort study, we found that current commonly used eligibility criteria would exclude approximately 90% of patients, significantly limiting study generalizability. Substantial differences in sample attrition between PLD and ALD cohorts highlight the need for tailored criteria. The strength of scientific justification varied widely among criteria.
Conclusions: This study demonstrates the importance of using RWD to optimize eligibility criteria in PLD clinical trials. By providing insights into the balance between sample attrition and scientific justification, researchers can enhance trial feasibility, generalizability, and robustness. Our RWD sample demonstrates that researchers could substantially increase the sample yield from 10% to 64% by loosening restrictions on coinfections and misdiagnoses of chronic fatigue syndrome, fibromyalgia syndrome, and psychiatric conditions.

Category:

Lyme, research

UN Adopts Controversial Cybercrime Treaty & New Administration Looks to Withdraw From WHO

https://reclaimthenet.org/un-cybercrime-treaty-human-rights-concerns-ratification

UN General Assembly Adopts Controversial Cybercrime Treaty Amid Criticism Over Censorship and Surveillance Risks

Global cybercrime treaty faces scrutiny over human rights safeguards and potential misuse of cross-border powers.

Didi Rankovic

Silhouette of a person holding a phone in front of a large painted eye on a red, textured background.

As we expected, even though opponents have been warning that the United Nations Convention Against Cybercrime needed to have a narrower scope, strong human rights safeguard and be more clearly defined in order to avoid abuse – the UN General Assembly has just adopted the documents, after five years of wrangling between various stakeholders.

It is now up to UN-member states to first sign, and then ratify the treaty that will come into force three months after the 40th country does that.

The UN bureaucracy is pleased with the development, hailing the convention as a “landmark” and “historic” global treaty that will improve cross-border cooperation against cybercrime and digital threats.

But critics have been saying that speech and human rights might fall victim to the treaty since various UN members treat human rights and privacy in vastly different ways – while the treaty now in a way “standardizes” law enforcement agencies’ investigative powers across borders.

Considerable emphasis has been put by some on how “authoritarian” countries might abuse this new tool meant to tackle online crime – but in reality, this concern applies to any country that ends up ratifying the treaty.

Another point of criticism has been that UN members individually already have laws that address the same issues, rendering the convention superfluous – unless it is to extend some of those authoritarian powers to the countries that don’t formally have them, and can’t outright pass them at home for political reasons.

Since the UN General Assembly adopted the resolution without a vote – after the text was previously agreed on by negotiators – it is not immediately clear how many countries might sign it next year, and ratify what would then become a legally binding document.

In the meanwhile, a spokesperson for UN Secretary-General Antonio Guterres referred to the treaty as “a demonstration of multilateralism.”

Where opponents see potential for undemocratic law enforcement practices spilling over sovereign borders, UN representatives speak about “an unprecedented platform for cooperation” that will allow agencies to exchange evidence, create a safe cyberspace, and protect victims of crimes such as child sexual abuse, scams and money laundering.

And they claim all this will be achieved “while safeguarding human rights online.” (See link for article)

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https://www.dailymail.co.uk/news/article-14224123/Trump-withdraw-puppet-Beijing-Covid

Trump looks to withdraw from WHO on first day of his administration after calling the health body a puppet of Beijing for failing to hold China accountable for COVID

By OLIVIA CHRISTIE

Donald Trump‘s presidential transition team is planning an immediate withdrawal from the World Health Organization, an expert familiar with the discussions has said.

The president-elect, 78, has repeatedly called the health body a puppet of Beijing for failing to hold China accountable for the early spread of Covid-19.

Members of Trump’s team have now told experts of their intention to withdraw from the WHO on January 20 – the first day of his second term.

‘I have it on good authority that he plans to withdraw, probably on Day One or very early in his administration,’ said Lawrence Gostin, professor of global health at Georgetown University in Washington and director of the WHO Collaborating Center on National and Global Health Law.

The Financial Times was first to report on the plans, citing two experts. The second expert, former White House COVID-19 response coordinator Ashish Jha, was not immediately available for comment.

A withdrawal from the WHO would mark a dramatic shift in US global health policy and further isolate Washington from international efforts to battle pandemics.

The departure would also deny the healthy body of its biggest donor with the US providing the WHO with about 16 per cent of its funding in 2022-23. (See link for article)

For more:

Category:

Activism, Treatment, vaccines, Viruses

Study Shows Worm-Like Self Assembling Entities in Bodies Who Got COVID Shots

https://slaynews.com/news/worm-like-self-assembling-entities-found-bodies-covid-vaccinated-study-warns/

‘Worm-Like Self-Assembling Entities’ Found in Bodies of Covid-Vaccinated, Study Warns

Frank Bergman
A disturbing study has reportedly found evidence of “self-assembling entities” in the bodies of people who received Covid mRNA “vaccines.”

Leading researchers in South Korea and Japan have issued a red alert after their bombshell study discovered the entities they described as “worm-like.”

According to the study, the “self-assembling entities” form “synthetic” nanostructures in the bodies of people who were “vaccinated” with Covid mRNA injections.

The shocking discovery of these “artificial constructions” was revealed in the long-term study’s recently published paper.

The study was led by South Korean obstetrician Dr. Young Mi Lee and Professor Daniel Broudy of Japan’s Okinawa Christian University.

Following their long-term study of Covid mRNA-vaccinated individuals, Lee and Broudy suggested that their main findings were the direct observation of both “self-assembling entities … of many different shapes,” and of “cellular toxicity” triggered by the Covid injections.

They noted that these discoveries were “especially” observed in blood and sperm cells.

In a Korean laboratory, using flu vaccine and normal saline as controls, the researchers incubated Pfizer and Moderna Covid mRNA “vaccines” in various fluids.

Important detail:

AstraZeneca and Novavax injections did not develop the “self-assembled” structures seen in the Pfizer and Moderna mRNA shots.

The findings resemble objects other doctors have been finding including ‘wires’ with frayed edges around which apparent ‘chips’ often appeared.  These wires were also found in the blood of the ‘vaccinated.’

Each injection was found to have ‘toxic effects on blood cells.’

Each shot had a distinct effect on blood cells:

  • Pfizer triggers “cellular collapse of white blood cells and damaged platelets.”
  • Moderna triggers rouleaux (stacking) of red blood cells.
  • Novavax causes the disintegration of the nucleus of white blood cells and some rouleaux of red blood cells..
  • AstraZeneca triggers “prominent rouleaux.”

Research also shows those who got the clot shot emit a fluorescent orange glow in their faces that is visible under UV light.  Those exposed to shedding emit the glow around their nose.  (See link for article)

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https://jamesroguski.substack.com/p/not-safe-and-not-effective?

NOT Safe And NOT Effective

This free online resource provides EVIDENCE that the mRNA platform is a biological weapon delivery system and its ongoing and expanded use constitutes a grievous crime against humanity.

Dec. 26, 2024

By James Roguski

Resource Center:

The purpose of this Resource Center is to make it easier for those who want to learn more to be able to access a wealth of information about the mRNA “vaccines” all in one location.

This Resource Center provides easy access to the best-of-the-best EVIDENCE showing that the Pfizer and Moderna mRNA “vaccines” should be removed from the marketplace IMMEDIATELY.

This series of articles/chapters will be published one per day beginning on December 26, 2024.

You may read all 26 articles/chapters now (before they are officially published) by clicking on the links below, but the comment section on each individual article will not be available until the scheduled publication date listed in parentheses below.

  1. NOT Safe And NOT Effective (this article) (Published: 12/26/24)
  2. An Open Letter to President Donald J. Trump (Published: 12/27/24)
  3. An Open Letter to Pam Bondi (12/28/24)
  4. An Open Letter to Robert F. Kennedy Jr. (12/29/24)
  5. Evidence of Military Control (12/30/24)
  6. A Timeline of Deception, Fraud and Coverup (12/31/24)
  7. Evidence From the Pfizer and Moderna Papers (1/1/25)
  8. Evidence of Harm (1/2/25)
  9. Evidence of Harm in VAERS (1/3/25)
  10. Evidence of Harm in V-safe (1/4/25)
  11. Evidence of Harm to Unborn and Nursing Infants and Their Mothers (1/5/25)
  12. Testimonies and “Anectodal Stories” (1/6/25)
  13. Evidence that the mRNA “Vaccines” are NOT effective (1/7/25)
  14. Evidence that the Spike Protein is Toxic (1/8/25)
  15. Evidence that the Lipid Nanoparticles are Toxic (1/9/25)
  16. Evidence of DNA Contamination (1/10/25)
  17. Evidence of Shedding (1/11/25)
  18. Evidence of Increased Morbidity and Mortality (1/12/25)
  19. Evidence From Autopsies (1/13/25)
  20. Evidence Regarding White Fibrous Structures (1/14/25)
  21. Evidence From Death Certificates (1/15/25)
  22. Word Crimes (1/16/25)
  23. Evidence of Fraudulent Misrepresentation (1/17/25)
  24. Movies and Books About the COVID-19 mRNA Injections (1/18/25)
  25. International Opposition to the mRNA Injections (1/19/25)
  26. How YOU Can Help (1/20/25)

If you have any questions or suggestions, please feel free to comment on this article or contact James Roguski directly at 310-619-3055 via phone, text, Signal, Telegram or WhatsApp.

The mRNA injectables are NOT “vaccines.”

THEY MUST BE TAKEN OFF THE MARKET IMMEDIATELY.

The mRNA injectable products from Pfizer and Moderna are gene-based biological weapons delivered by a lipid nanoparticle vector that was brought to you courtesy of Operation Warp Speed and the United States Department of Defense.

These biological weapons present a well-documented, imminent hazard to the health of everyone on earth. They have already killed thousands, possibly millions of people, and, due to a process known as shedding, the devastation that they cause extends even to those who have never actually received an mRNA injection.  (See link for article and videos)

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**Comment**

A new study finds COVID shots doubles your risk of post-COVID death, another paper shows COVID boosters increased mortality in nursing home residents and the effect was highly statistically significant after four weeks.

The U.S. Government Accountability Office (GAO) report found that ‘vaccine’ injury claims spiked 27X after COVID shot roll-out.

“If a child gets all the vaccines in the entire schedule, they get almost 13,000 micrograms of aluminum, and they get almost 600 micrograms of mercury, plus over 200 chemicals.  So that’s why they’ve never been proven to be safe.”  ~ Dr. Sherry Tenpenny

Category:

Activism, research, vaccines

Wisconsin DHS Reports Presumptive Positive Human Case of H5N1. Meanwhile Congress Looks to Bankroll More Biolabs to Experiment on Dangerous Pathogens

https://www.dhs.wisconsin.gov/news/releases/121824.htm

For Immediate Release
December 18, 2024
Contact
Elizabeth Goodsitt, 608-266-1683
Jennifer Miller, 608-266-1683

DHS Reports Presumptive Positive Human Case of Highly Pathogenic Avian Influenza (HPAI) in Wisconsin

The Wisconsin Department of Health Services (DHS) has detected the first presumptive positive human case of Highly Pathogenic Avian Influenza A (H5N1), also known as bird flu, in Barron County. The human case follows an infected flock of commercial poultry identified in Barron County. The person had exposure to the infected flock. The case was identified through testing at the Wisconsin State Lab of Hygiene (WSLH) and is pending confirmation at CDC (Centers for Disease Control and Prevention).

DHS, in coordination with Barron County Health and Human Services, is monitoring farm workers who may have been exposed to the virus and has provided them with information to protect their health. The risk to the general public in Wisconsin remains low. People who work with infected animals, or have recreational exposure to them, are at higher risk.

The H5N1 HPAI virus has continued to circulate in both wild and domestic birds in North America since December 2021. H5N1 HPAI viruses are highly contagious and often fatal to domestic poultry. Caused by influenza type A viruses, the disease can cause illnesses ranging from very mild to severe depending on the strain and species affected. The disease can spread from infected birds to people by contact with infected birds, commingling with wild birds or their droppings, equipment, or clothing worn by anyone working with the animals.

The virus does not spread easily from animals to people. People who have gotten sick with bird flu have been in direct contact with infected animals.

Symptoms of bird flu in people include:

  • Sore throat
  • Fever
  • Muscle aches
  • Cough
  • Eye infections (Conjunctivitis)

Anyone who develops symptoms of flu or an eye infection and has been in contact with animals who may have been infected should stay home (not go to work, school, shopping, or use public transportation) and call their doctor’s office or clinic before visiting so they can take precautions to ensure other patients are not exposed to the virus. Treatment for bird flu may include hospitalization, supportive care, and/or the use of antivirals.

It is safe to eat eggs, poultry, and meat that has been fully cooked. Pasteurized milk and milk products, such as cheese and yogurt, are also safe to eat and drink. General precautions should always be taken when handling any raw meat, including raw eggs, to avoid possibly spreading germs. These measures include:

  • Washing hands and surfaces before and after food preparation.
  • Avoiding using the same utensils on raw meat as on other foods, even cooked meat.
  • Cooking raw meat thoroughly.

Additional case counts will be posted to Outbreaks, Recalls, and Investigations in Wisconsin. Prevention information for farmworkers or others who have close contact with birds, dairy cows, or other relevant animals can be found under Protective Actions for People.

Category:

Activism, Transmission, Treatment, Viruses

Medical Detective #4: How to Survive in a Tick-Filled World

https://www.lymedisease.org/survive-in-tick-filled-world/

MEDICAL DETECTIVE #4: How to survive in a tick-filled world

This article was originally posted on Dr. Richard Horowitz’s Medical Detective Substack. You can find more helpful content by subscribing here. 

If I were to conjure up a global menace in a teeny-tiny package, I wouldn’t have to look far for inspiration. It’s already there, crawling down the legs of a deer or a dog and up the stalk of grasses or shrubs or plants in your garden, all primed and ready to latch on to your tender skin and take a nice big chomp!

It’s a tick-filled world and we’re stuck living in it.

And you know what’s making it worse? Climate change. The warmer the weather, the easier it is for ticks to breed. Increases in global temperatures increase the reproductive rates of insects, so we are seeing an explosion of not only pathogen-filled ticks, but also mosquitos that are potentially transmitting West Nile, Zika virus, Chikungunya, Dengue, other viruses and even malaria in the US.

The same pest-pocalypse is happening to other biting insects like fleas, mites, lice, etc. that can transmit a broad range of organisms, including Bartonella (more about this in future articles).

So remember, these insects, including ticks, may contain multiple bacteria, viruses, and parasites, and getting one bite can lead to more than one disease.

In fact, in my 40+ year experience treating chronically ill individuals, co-infections with multiple bacteria, viruses, and parasites are the rule, not the exception. And people usually end up getting multiple bites from ticks over their lifetime because these unbelievably annoying creatures are spreading rapidly and present in every corner of the globe (even Antarctica!).

Gruesome–but necessary–reading

Learning about how ticks live and feed makes for pretty gruesome reading.

Suffice to say that they go through four life stages: egg, six-legged larva, eight-legged nymph, and adult. The only course they have on their menu is blood, thanks to their bites on either animals or humans.

If they bite an animal that’s already carrying a pathogen, they can then transmit that bug to the next unlucky recipient of their cunning. Hopefully that won’t be you!

[Image from the Forest Service, USDA.]

And get this–some of these ticks are hermaphrodites, like the rapidly spreading Asian bush tick, Hemophylis Longicornis, which means they can reproduce without mating. This also means that they are reproducing more rapidly than other ticks.

Although they haven’t been proven yet to transmit some of the multiple infections now being found in them (Borrelia burgdorferi, i.e., Lyme disease, tularemia, Rickettsia like Rocky Mountain Spotted fever, Heartland, and Bourbon viruses), time will tell.

In Asia, these same ticks can cause alpha gal syndrome, the “red meat allergy” as well as SFTS (Severe Fever and Thrombocytopenia Syndrome), a potentially fatal illness.

Bottom line: if you get bitten, you want to know what kind of tick it is, and what pathogens it contains.

Different varieties in different regions

As you’ve unfortunately realized by now, there are many varieties of ticks that live in different areas of the U.S. (I’ll discuss this in an upcoming posting, but for now you can check this map: https://www.cdc.gov/ticks/data-research/facts-stats/geographic-distribution-of-tickborne-disease-cases.html.)

Not every tick is a carrier of a pathogen–only the black-legged deer tick can transmit Lyme Disease, for example–so getting bitten doesn’t automatically guarantee that you’ll get sick. But enough ticks are infected in this country and abroad, and can spread any or more of these 20 diseases with just one bite, as you can see from this CDC list:

Where Are Ticks Lurking?

Ticks are tenacious, and can be found even in urban environments you’d think would be free of them. According to the New York City Department of Health, for example, there were 3,323 (2,482 new ones and 741 positive ones from previous years) reported cases of Lyme disease in NYC residents in 2023. This is up from 2,524 cases in 2022.

There were also 77 reports of anaplasmosis and 116 of babesiosis in 2023. I suspect that these cases were picked up while in any of the city’s many parks, but who knows?

These numbers are likely gross underestimates of how bad the problem truly is, because several of the diseases we will be discussing can’t easily be picked up on standard blood tests, and doctors may not know to always look for them since some of the symptoms are non-specific and overlap other illnesses.

As I’ve said in earlier posts, last year alone, the CDC reported 476,000 cases of Lyme disease in the US, and their recent implementation of a revised case definition reported that case counts are rising where the incidence was 1.7 times the annual U.S. average in 2017–2019, an overall 68.5% increase, rising with patient age.

If you’re going outside to an environment where ticks are hiding—going to a park, hiking on trails in fields or forests, or while gardening, for example—follow these tips.

Tick Lookout Tips

  • Ticks can’t ‘officially’ fly, although static electricity from animals results in ticks being pulled by these electric fields across air gaps measuring several of their body lengths, resulting in leaps that one could almost define as flying. They also don’t jump, so they have to crawl from host to host as their primary means of attachment. They lurk. They wait. (This is called “questing.”)
  • The little monsters are clever enough to detect a potential host by sensing body heat, moisture, odors, or carbon dioxide; or by the vibrations of someone passing by. Although the deer tick (Ixodes scapularis in the northeastern US) or Ixodes pacificus (in the Pacific US), can sense your presence from 12 feet away and come running, some of these ticks like the lone star tick (Ambylomma Americanum) can sense your heat and carbon dioxide from up to 50 feet away. They will come after you to bite you from quite a distance, even if you are not in high grass or directly exposed.
  • As soon as they can climb onto where they aren’t wanted, they either latch on in one spot, or take their time wandering around your body where skin might be thinner and easier to bite.
  • So when you go outside, stay in the middle of any trails, away from tall grasses, branches, and leaves. Try not to brush up against any foliage. Ticks also like to quest in border areas in the yard or park and near bird feeders.
  • If you have a yard, keep the grass short. If you have a compost pile, or piles of leaves, stay out of them!
  • Don’t sit directly on the ground, on large stones or fallen logs, or on stone or brick walls.

This is part one of a two-part series about ticks originally published on Substack by Dr. Richard Horowitz. You can read the second part in the next Substack. 

See also:

“Medical Detective” series brings information you need to know

MEDICAL DETECTIVE #1: An overview of Lyme disease signs and symptoms 

MEDICAL DETECTIVE #2: How Will I Know If I Have Lyme Disease?

MEDICAL DETECTIVE #3: Let’s Talk About Lyme Rashes

Dr. Richard Horowitz has treated 13,000 Lyme and tick-borne disease patients over the last 40 years and is the best-selling author of  How Can I Get Better? and Why Can’t I Get Better? You can subscribe to read more of his work on Substack or join his Lyme-based newsletter for regular insights, tips, and advice.

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**Comment**

Dr. Horowitz is incorrect concerning ‘climate change’ making ticks and the diseases they carry worse.  Independent research has clearly shown ticks are on the move due to migrating birds and photoperiod (not to mention agents of our own government purposely infecting ticks with pathogens and then kicking boxes full of them out of airplanes).  Further, research blaming ‘climate change’ for every ill under the sun is based on biased research using an erroneous model.

Utilizing erroneous models was also clearly seen during the COVID psyop and continues to this day.

A bought out, biased media is also using corrupt data to spread this climate alarmism.

Due to highly sought after government grants, researchers have also fallen prey to conducting biased research, making claims that are not supported by data.

A train of articles have come out on how research and medicine have been hijacked and are completely driven by an unholy alliance with Industry, government, and University research facilities.  Besides being unethical, which should be troublesome on its own, it causes patient suffering.

‘Science’ is funded primarily by industry and this conflict of interest means there is little honest research being done.

Category:

Activism, Climate, research, Ticks