Archive for the ‘research’ Category

Twenty-Three Years of Unnecessary Suffering: How the Medical Establishment Got Away With Maligning Hormones

https://popularrationalism.substack.com/p/twenty-three-years-of-unnecessary?

Twenty-Three Years of Unnecessary Suffering: What the Women’s Health Initiative Actually Showed — and What the Medical Establishment Did With It

If you are a woman 40 to 50, your choice to pay attention to or ignore this information will – not may, WILL dramatically impact your quality of life.

On November 10, 2025, the United States Food and Drug Administration quietly did something it almost never does: it reversed itself.

The FDA announced the removal of what it described as “misleading warnings” on hormone replacement therapy, stating in language that should be read carefully by every woman over forty in this country that “estrogen is a key hormone for women’s health where every single part of a woman’s body depends on estrogen to operate at its best — including the brain, bones, heart, and muscles.”

That sentence took twenty-three years to come out of a federal regulatory agency. Those twenty-three years have a body count — not of deaths from hormone therapy, but of preventable fractures, preventable cardiovascular events, preventable cognitive decline, and an incalculable accumulation of unnecessary suffering by women who were told, on the authority of science, to stop their treatment. Or to never start it.

The story of how this happened is the kind of story this publication exists to tell. It involves a landmark study whose design was unsuited to the question it was used to answer, relative risk inflation dressed up as settled science, a medical establishment that moved faster to alarm than to correct, and a generation of women who paid the cost.  (See link for article)

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**Comment**

Hormones are huge.  Huge.

Besides helping virtually everything physiologically, they are also drivers of behavior (or lack thereof). However, due to all the xenoestrogens in plastics, pesticides, and personal care products, our society is typically estrogen high – and the wrong, synthetic form at that, disrupting hormonal balance and affecting health negatively.  Just watch a film made in the 70’s or 80’s and then compare the bodies in it to the average population now.

BTW: I’m not a fan at all of equine estrogen due to the horrible way it is made, and I’m not a big fan of synthetic hormones created in a lab often from animal sources (unless for rare special circumstances).  In my opinion, bioidentical hormones that are chemically identical to the hormones naturally produced in the human body are more bioavailable as well as safer.

The sad truth is that the Women’s Health Initiative (WHI) was stopped early due to a small but statistically significant increase in breast cancer, cardiovascular events, and stroke in the hormone group compared to the placebo group.  From that point on, hormones were branded as killers and avoided like the plague by mainstream doctors.

Weiler points out the following problems with the study:

  • the average age of participants in the trial was 63
  • many had pre-existing cardiovascular risk
  • many were put on hormone therapy for the first time years AFTER their estrogen collapsed

Further, there’s the sticky problem of absolute risk – a problem  discussed regarding the COVID jabs as well, and a widely used technique to get a study to say what you want it to say.

The absolute risk increase for breast cancer in the combined hormone group — the number that actually describes what happened to real women in real terms — was approximately eight additional cases per ten thousand women per year, compared to placebo. That is a relative risk increase that translates, in absolute terms, to a risk that is smaller than the baseline absolute risk increase associated with drinking one alcoholic beverage per day, or with being sedentary, or with being obese.

Weiler further adds that while breast cancer is devastating and must be included in the conversation:

relative risk, stripped of its denominator, is a rhetorical instrument. When the baseline rate is small, a relative risk of 1.26 can be presented as a twenty-six percent increase in breast cancer — which is how it was widely framed — or as eight additional cases per ten thousand women per year in a specific, older population — which is what it actually meant. These are not equivalent framings. The first drives panic. The second permits informed decision-making.

The risks became headlines but the significant benefits in reduced hip fractures, colorectal cancer, and relief from vasomotor symptoms became the footnote.  This is how you rig a study.

Researchers now understand that  there is a critical window regarding HRT and the benefit-risk profile is different depending on when it is initiated.

I short, women who begin HRT within a ten year window of the onset of menopause (or before age 60) have cardiovascular outcomes that are neutral to favorable.  Women who start HRT a decade or more after menopause show a less favorable profile because the vascular and neural adaptation to estrogen withdrawal have already occurred.

Who benefits from this travesty?
Big Pharma of course

Women who stopped taking HRT switched over to individual pharmacological agents targeting individual symptoms – and there’s a bevy of them!  Since the systemic solution of hormone therapy that would have solved all the symptoms was maligned, Big Pharma now had a collection of targeted interventions bringing in separate revenue streams!

Weiler then drives the message home by showing the HRT saga is not an isolated event but a documented pattern of what happens when:

a large, expensive, federally funded study  conducted on a population that does not match the clinical target using a formulation or intervention that does not match the clinical practice being evaluated, producing findings that are communicated in relative rather than absolute terms, and whose findings are translated into guidelines and clinical practice with a speed and thoroughness that is never matched by the subsequent corrections.

And this, right here, is why I’m against ANY large, expensive, federally funded study for Lyme disease – and for the same reasons.

The WHI results changed clinical practice within months but took a decade and a half to change – yet, are still not uniformly reflected in practice.  

For more:

1 in 3 Cancer-Free: Ivermectin Trial Stuns, but RESET-5 Aims Even Higher

https://zenodo.org/records/19455636

Real-World Clinical Outcomes of Ivermectin and Mebendazole in Cancer Patients: Results from a Prospective Observational Cohort

Description

Abstract

Background: Drug repurposing offers a pathway to identify accessible, low-toxicity cancer therapies. Ivermectin and mebendazole have demonstrated multi-target anti-cancer activity in preclinical models, including the inhibition of cancer cell proliferation and the targeting of cancer stem cells. This paper evaluates real-world patient-reported outcomes, safety, and adherence in a cohort of cancer patients utilizing this combination protocol.

Methods: We analyzed a prospective observational cohort of 197 cancer patients who were prescribed ivermectin and mebendazole off-label through a telemedicine platform by licensed U.S. healthcare providers. Participants received compounded oral capsules containing 25 mg ivermectin and 250 mg mebendazole. As part of a clinical program evaluation, data were collected via voluntary, standardized digital surveys at baseline and at approximately 6-month follow-up. Of the initial cohort (N = 197), baseline characteristics, including cancer type and disease status, were assessed. A total of 122 participants completed the follow-up survey (61.9% response rate) to evaluate self-reported cancer outcomes, medication adherence, and adverse events. 95% confidence intervals (CI) were calculated for primary outcome measures using the Wilson score method. Dose-stratified analyses for outcomes and safety were conducted using Chi-square statistics.

Results: The cohort represented a diverse clinical profile of cancer patients, with mean age of 67 years and nearly balanced sex distribution (52.3% male, 47.7% female). Cancer types included prostate (27.9%), breast (18.3%), lung (8.6%), colon (5.1%), urologic (4.6%), pancreatic (3.0%), liver (2.5%), gynecologic (2.5%), and hematologic (2.5%) malignancies. At enrollment, participants had a median duration since initial diagnosis of 1.2 years, with 37.1% experiencing active disease progression. At 6-month follow-up, medication adherence was high with 86.9% of participants completing the full initial 90-capsule ivermectin-mebendazole prescription and 66.4% remaining on the protocol at 6 months. The Clinical Benefit Ratio (CBR) was 84.4% (95% CI: 77.0–89.8%). Notably, 48.4% (95% CI: 39.7–57.1%) of the cohort reported the strongest positive outcomes, consisting of regression (15.6%; 95% CI: 10.2–23.0%) or no current evidence of disease (NED, 32.8%; 95% CI: 25.1–41.5%). Disease stability was reported to be maintained in 36.1% (95% CI: 28.1–44.9%) of participants, while 15.6% (95% CI: 10.2–23.0%) reported disease progression. While 25.4% reported mild side effects (primarily gastrointestinal), 93.6% of those affected continued treatment through minor dose adjustments. Some participants reported concurrent conventional therapies, including chemotherapy (27.9%), radiation therapy (21.3%), and surgery (19.7%), as well as adjunctive interventions such as supplement use (49.2%), dietary modification (37.7%), and other integrative approaches.

Conclusions: In this prospective real-world cohort, the combination of ivermectin and mebendazole was associated with high rates of self-reported clinical benefit, with nearly half of participants reporting tumor regression or no current evidence of disease across a heterogeneous population of cancer patients. These findings provide a compelling clinical signal that these well-tolerated, repurposed agents may offer therapeutic benefit. However, given the observational design, reliance on self-reported outcomes, and potential for selection bias and uncontrolled confounding, these findings should be interpreted as hypothesis-generating. Urgent prospective, randomized, placebo-controlled clinical trials are warranted to validate these observations and further define optimal dosing strategies. (Go to link for full-length study)

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**Comment**

http://

Could These Overlooked Drugs Be a Cancer Game-Changer?

Dr. Ken Stoller, April 12, 2026

For a wonderful breakdown of the study:  https://justusrhope.substack.com/p/1-in-3-cancer-free-ivermectin-trial?  Excerpt:

Dosages and Concurrent Therapies

Patients were prescribed the medications off-label through a telemedicine platform. They received compounded oral capsules containing:

  • 25 mg of Ivermectin
  • 250 mg of Mebendazole

The study noted that these were not strictly monotherapies. Many patients were undergoing concurrent conventional treatments, including chemotherapy (27.9%), radiation therapy (21.3%), and surgery (19.7%). Additionally, many used adjunctive interventions such as supplements (49.2%) and dietary modifications (37.7%).

Study Completion and Attrition

Of the initial 197 patients, 75 patients failed to complete the study (meaning they did not complete the 6-month follow-up survey).

  • A total of 122 participants completed the 6-month follow-up survey, resulting in a 61.9% response rate.
  • Among the 122 who responded, adherence was high: 86.9% completed the full initial 90-capsule prescription, and 66.4% chose to remain on the protocol at the 6-month mark.

Clinical Outcomes and Tolerability

The authors reported an overall Clinical Benefit Ratio (CBR) of 84.4% among the 122 patients who completed the survey. The self-reported outcomes broke down as follows:

  • No Evidence of Disease (NED): 32.8%
  • Disease Stabilization: 36.1%
  • Tumor Regression: 15.6%
  • Disease Progression: 15.6%

Within the article, Justuserhope asked AI to evaluate the benefit of adding one agent at a time from the RESET-5 Protocol (Mebendazole, ivermectin, sulforaphane, metformin, and aged garlic extract) to the Hulscher et. al study.  The full RESET-5 reduces the likelihood of resistance development, enhances immune function, and depletes tumors of a critical survival tool – compensatory glutathione production.

The full RESET-5 Protocol boosts improvement even further by 30-40%.

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**Comment**

For those of you studying this, 25 mg of ivermectin and 250mg of Mebendazole are considered pretty low dosages.  Many patients are taking much more than that, so the fact they are getting such great improvement with such low dosages is fairly amazing.  Lower dosages typically mean lower side-effects so this should be safe for nearly all to take.  Share with your doctor and work together to get the best fit.

For more:

Tools, Hope, & Healing in Lyme Disease: Dr. Joseph Jemsek

http://

Mar 24, 2026
A webinar and Q&A on tools, hope and healing for those affected by Lyme disease with special guest Dr. Joseph Jemsek.
Sponsored by the National Lottery Community Fund and facilitated by Lyme Disease UK Patient Ambassador Morven-May MacCallum.
Joseph Jemsek, MD, trained as an infectious disease specialist and dedicated the first 20 years of his practice to patients with HIV/AIDS. In the early 2000s, an influx of patients from all over the United States started flooding his practice, the Jemsek Clinic, complaining of chronic symptoms of Lyme disease. This was the start of an unexpected new chapter that would change the course of Lyme disease treatment and of Dr. Jemsek’s own life. Dr. Jemsek evaluated over 15,000 cases of Lyme and other tick-borne illnesses and introduced dozens of pioneering treatment innovations.
You may sign up for Dr. Jemsek’s newsletter, Choose Life Over Lyme!, where he’ll be sharing twenty-five years of insights from his work decoding Lyme disease, at ChooseLifeOverLyme.com
You can access his guide Self-Help Tools to Manage Lyme Borreliosis Complex co-created with Lyme Disease UK here: lymediseaseuk.com/wp-content/uploads/2026/03/Self-Help-Tools-2026-.pdf
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**Comment**
Highly recommend!  Dr. Jemsek is not treating patients anymore but his expertise is phenomenal.  He was also persecuted for prescribing long term antibiotics to treat chronic Lyme by the North Carolina Medical Board which restricted his medical license, but was vindicated. You won’t regret the time you spend watching this.
For more:

Lost Signals: Study Shows VAERS Buries Vaccine Harm & CDC, FDA Admit to Using ‘Mostly Useless’ Tool

https://imahealth.substack.com/p/lost-signals-new-study-shows-how?

Lost Signals: New Study Shows How VAERS Buries Vaccine Harm

VAERS already catches only a fraction of vaccine harm. New research by Jessica Rose reveals the system is losing even more data to fixable flaws.

America’s vaccine safety system already catches only a fraction of the harm that occurs. That much has been known for years. VAERS is a passive reporting system, and most adverse events are never reported at all.

But what happens to the data that does make it in?

A new study by Jessica Rose, a computational biologist, immunologist, and IMA Senior Fellow, shows that VAERS is losing critical safety data from the inside. The system’s own infrastructure is so outdated and poorly maintained that real signals of harm are being buried by fixable data problems. When Rose cleaned the data and reassembled what had been scattered, she found safety signals for fetal loss and cardiac arrest that had been there all along, invisible to anyone using the system as designed.

“The main claim to fame here is that I pointed out some of the problems inherent in VAERS that most people, unless they’re using it as part of data analysis, wouldn’t really know about.” — Jessica Rose

📖 Read and Download the Full Paper

Minimizing Signal Loss and Optimizing Pharmacovigilance in VAERS (JIM Vol. 2, No. 2, 2026) — Author: Jessica Rose

👉 Visit the Journal of Independent Medicine to create a free account and download the full article.

What’s Broken in VAERS?

VAERS was built in the 1980s and has operated with the same basic infrastructure ever since. Reports are submitted through an online form that takes about 30 minutes to fill out. There are no pull-down menus. No standardized formats for vaccine lot numbers or dates. The form has session timeouts that can erase a report before it’s finished. And the system creates multiple IDs for the same patient rather than linking a serious reaction to a follow-up death report.

The people filing reports experience these problems every time they sit down to submit one. But the people relying on the data to detect harm may never realize what’s being lost.

Rose showed just how small the fixes can be. Two simple corrections to vaccine lot numbers (capitalizing letters and removing stray spaces)  recovered 8,871 reports that had been invisible to analysis. Not because the data was missing. Because the system couldn’t recognize its own records.

(See link for article and video)

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https://childrenshealthdefense.org/defender/cdc-fda-admitted-mostly-useless-tool-detect-covid-vaccine-safety-signals/

CDC, FDA Admitted to Using ‘Mostly Useless’ Tool to Detect COVID Vaccine Safety Signals

Federal health officials knew the statistical tool they relied on to look for COVID-19 vaccination safety signals in VAERS was “mostly useless,” according to internal documents obtained by Sen. Ron Johnson and analyzed by scientists at Children’s Health Defense. CDC and FDA researchers used the tool anyway to create analyses they tried to publish that supported the vaccines’ safety.

files and covid vaccine

Federal health officials knew that the statistical tool they relied on to look for COVID-19 vaccination safety signals in the Vaccine Adverse Event Reporting System (VAERS) was “mostly useless,” according to internal documents obtained by Sen. Ron Johnson (R-Wis.) and analyzed by scientists at Children’s Health Defense (CHD).

The documents show that officials at the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) internally acknowledged that the tool — empirical Bayesian (EB) data mining — had “blind spots” that rendered it “mostly useless” for picking up on safety signals of COVID-19 vaccines.

Yet, the agencies used the method in analyses and attempted to publish findings from those analyses — including studies that supported the safety of COVID-19 vaccines.

Karl Jablonowski, Ph.D., CHD senior research scientist who analyzed the documents, told The Defender:

“Imagine a night watchman has to find something on the ground. But instead of holding a flashlight, he is wearing sunglasses. In the morning, he says he didn’t find anything. That’s true, but it’s because he was using a tool that impeded his ability to see.”

The records obtained by Johnson’s office include emails between CDC and FDA researchers from 2021 to 2023, along with draft manuscripts and peer reviewer comments.

In one case, researchers sought to publish an analysis in The Lancet Infectious Diseases using EB data mining on early COVID-19 vaccine data. They dropped the plan only after a reviewer wrote that the likelihood of detecting a safety signal using the method was “likely close to zero.”

FDA official Dr. David Menschik, who initially was a co-author on the paper, wrote to the study’s lead author in December 2021 saying he knew the method was essentially useless.

“We acknowledged this in the limitations and understand that there is a considerable bias toward the null when using our data mining methods in this current, unprecedented situation,” he wrote.  (See link for article)

For more:

GBS as an Initial Manifestation of Lyme Disease: Diagnostic Challenges

https://www.cureus.com/articles/467640-guillain-barr-syndrome-as-the-initial-manifestation-of-lyme-disease-diagnostic-challenges

Guillain-Barré Syndrome as the Initial Manifestation of Lyme Disease: Diagnostic Challenges

Ahmed Elnour • Naveed Sultan • Abdul Monem • Khalid Ghalib

Published: March 20, 2026

DOI: 10.7759/cureus.105552

Peer-Reviewed

Cite this article as: Elnour A, Sultan N, Monem A, et al. (March 20, 2026) Guillain-Barré Syndrome as the Initial Manifestation of Lyme Disease: Diagnostic Challenges. Cureus 18(3): e105552. doi:10.7759/cureus.105552

Abstract

Lyme disease is a common tick-borne infection in the United States and Europe that may involve the nervous system during the disseminated stage. Guillain-Barré syndrome (GBS) is an acute immune-mediated polyneuropathy usually triggered by infection; however, its association with Borrelia burgdorferi is uncommon and can pose diagnostic challenges.

We report the case of a previously healthy 61-year-old female patient who presented with progressive ascending weakness and areflexia suggestive of GBS. During hospitalisation, she developed bilateral facial nerve palsy, prompting further evaluation. Cerebrospinal fluid (CSF) findings and electrophysiological studies supported acute inflammatory demyelinating polyneuropathy, while serologic testing confirmed Lyme disease. The patient received intravenous immunoglobulin (IVIG) followed by intravenous ceftriaxone and achieved complete neurological recovery.

This case emphasizes the need to consider Lyme disease in patients presenting with acute inflammatory neuropathy, particularly in endemic regions, as early diagnosis and targeted therapy can significantly improve outcomes.

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**Comment**

The researchers state that the association between GBS with Lyme is uncommon, yet nobody is counting cases!  How can they know?

Answer: they don’t.  They shouldn’t state things that are pure conjecture.

For more: