Archive for the ‘Testing’ Category

TBI Diagnosis, Treatment & Link to UTI

http://  Approx. 40 Min

Tick-borne Infection: Diagnosis, Treatment & the Link to UTI

Live UTI Free
Nov 25, 2024
Greg Lee is the founder of the Lyme Research and Healing Center and LymeResearchCenter.com.
In this interview he shares insights around the following questions:
👉 What is Lyme disease and what other organisms can ticks transmit?
👉 Is it possible to have contracted a tick-borne infection without developing a ‘bullseye rash’?
👉 What are the symptoms of an acute or chronic tick-borne infection?
👉 Is it possible to have chronic Lyme disease despite initial antibiotic treatment?
👉 Are there other medical conditions with symptoms similar to those of chronic Lyme disease?
👉 What is the relationship between biofilms and tick-borne infections?
👉 How do you test for Lyme disease?
👉 How is chronic Lyme disease treated?
👉 What is mold toxicity, and what are the symptoms?
👉 How can you test for and treat mold toxicity?
Go here to get your FREE report on the top 5 essential oils for chronic UTIs.
For more:

Category:

Biofilm, Lyme, Mold, Testing, Treatment

When a Tick Changes the Game: Jared Allen’s Battle with Alpha-Gal Syndrome

https://www.si.com/everyday-athlete/nfl-legend-jared-allen-s-tick-bite-diagnosis-every-athlete-needs-to-know-about

NFL Legend Jared Allen’s Tick Bite Diagnosis Every Athlete Needs to Know About

John Welbourn

When a Tick Changes the Game: Jared Allen’s Battle with Alpha-Gal Syndrome

Most athletes know the importance of diet when it comes to peak performance; what you eat fuels your training, recovery, and overall health. But what happens when something as small as a tick forces you to rethink how you fuel your body completely? That’s precisely what happened to former NFL legend Jared Allen, who recently opened up about his battle with alpha-gal syndrome, a tick-borne food allergy that has reshaped his lifestyle—and his plate.

What is Alpha-Gal Syndrome?

Alpha-gal syndrome (AGS) is an allergy caused by the bite of the Lone Star tick, commonly found in the southeastern and midwestern United States. Unlike typical food allergies that react to things like peanuts or shellfish, AGS is unique: it causes the body to have a delayed allergic reaction to red meat and other mammal-based products. That means beef, pork, lamb, venison, and even hidden mammal-derived ingredients in foods or supplements can trigger severe symptoms.

The reaction doesn’t always happen immediately after eating, which makes it tricky to diagnose. Symptoms can range from stomach pain and hives to life-threatening anaphylaxis hours after a meal.

Jared Allen’s Diagnosis

For Jared Allen—known for his grit and strength on the football field—the diagnosis meant he had to completely cut mammal meat out of his diet and switch to what he calls a “fins and feathers” lifestyle, sticking to poultry and fish. Imagine going from fueling your body with steak or burgers after grueling workouts to suddenly being told those foods could send you to the ER. That’s a massive change for anyone, let alone a professional athlete used to finely tuned nutrition. (See link for article)

_____________

**Comment**

My son was recently bitten by a Lone star tick.  Well, I should say he was nibbled on by a LS tick, leaving a minuscule red pin prick.  The tick was not remotely engorged.  I received the frightening text from him but admitted I needed to brush up on all of this as so far Wisconsin patients are still mostly dealing with black legged ticks and Lyme/MSIDS even though Lone Star ticks have been found here.

But, the nibble was enough to cause profound illness in 2 weeks time.  (Yes, I’m kicking myself for not demanding prophylactic treatment, but we all grow slack at some point and need a wake-up call.  This was it!) 

His symptoms sounded exactly like Lyme but he was worried he had also developed Alpha Gal as he would get diarrhea within a few hours of eating red meat.  Thankfully this dreaded symptom quickly went away.

All I initially remembered was that LS ticks transmit not only Alpha Gal Syndrome (AGS) the meat allergy the NFL star got, but also STARI, which looks, smells, and acts just like Lyme disease, despite the fact at least 9 transmission experiments involving B. burgdorferi in Lone Star ticks have failed to demonstrate vector competency.  The offending agent of STARI is B. lonestari not B. burgdorferi, but the illness looks the same.  Go here for the nuts and bolts.

BTW: STARI is also called Masters’ disease, named after famed rebel Dr. Ed Masters who took the CDC on single-handedly and outwitted them.  All of Masters’ patients improved dramatically with extended antibiotic treatment despite the CDC’s belief that antibiotics should be used sparingly, if at all.

So, what to do?

Well, I figured if this looked and felt exactly like Lyme, it would respond to Lyme treatment.  My son went on the following (reminder: I’m not a doctor and I don’t diagnose or treat anyone):

  • 100mg minocycline, twice daily for two weeks; however when discontinued his symptoms returned, signaling that a layered approach was needed.  This is common.
  • he then pulsed 500mg tinidazole once a day for two successive days weekly
  • he then layered in 12mg ivermectin every other day
  • he did daily red light and sauna therapy
  • he did two rounds of EBOO (extracorporeal blood oxygenation and ozonation) 3 weeks apart.  He said the EBOO completely knocked him on his butt and he had to take a day off work to sleep, but that shortly he felt the best he had felt since starting treatment.
It took every bit of that treatment for three months to finally knock it.
 I’m happy to report he has remained symptom free.

On a side note, ivermectin and/or fenbendazole has:

This was not a fun experiment but I know how important it is to share our experiences, as that is often all we patients truly have – each other.

Category:

Alpha Gal Meat Allergy, Alzheimer's, Autism, Lyme, Parasites, research, Testing, Ticks, Transmission, Treatment

Klempner Study: How to Prove Extended Antibiotics Don’t Work For Chronic Lyme Disease – Fraudulently Done PCR

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/33805999?

Did Dr Mark Klempner purify samples before PCR in his NIH funded antibiotic treatment trials ?

Carl Tuttle
Hudson, NH, United States
Aug 18, 2025

“It would appear that Klempner’s methodology was fatally flawed in the two NIH studies that set the stage for treatment denial.” -Carl Tuttle

———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: “mark.klempner@umassmed.edu” <mark.klempner@umassmed.edu>
Cc: “michael.collins@umassmed.edu” <michael.collins@umassmed.edu>, “ddutko@hanszenlaporte.com” <ddutko@hanszenlaporte.com>, “ryan.kantor@usdoj.gov” <ryan.kantor@usdoj.gov>, “michelle.seltzer@usdoj.gov” <michelle.seltzer@usdoj.gov>, “william.rinner@usdoj.gov” <william.rinner@usdoj.gov>, “makan.delrahim@usdoj.gov” <makan.delrahim@usdoj.gov>, “john.elias@usdoj.gov” <john.elias@usdoj.gov>, “NIHResearchIntegrity@mail.nih.gov” <NIHResearchIntegrity@mail.nih.gov>, “support@grants.gov” <support@grants.gov>, “reviewpolicyofficer@od.nih.gov” <reviewpolicyofficer@od.nih.gov>, “AskORI@hhs.gov” <AskORI@hhs.gov>
Date: 08/17/2025 1:43 PM EDT
Subject: Did Dr Mark Klempner purify samples before PCR in his NIH funded antibiotic treatment trials for Lyme disease grants (N01-AI-65308 and M01 RR000054)

On 04/27/2018 7:53 AM EDT Carl Tuttle <runagain@comcast.net> wrote: “Not a single positive Dr. Klempner? Doesn’t this statistically prove that your methodology was fatally flawed?”

Dr. Klempner,
As a follow-up to my 2018 inquiry (which you did not respond) I would like to share a recent communication I had with Dr Sin Lee of Milford Molecular Diagnostics Laboratory, specializing in DNA sequencing-based diagnostics. Following his lead, I asked AI a question about your methodology for detecting Borrelia burgdorferi in your NIH funded antibiotic treatment trials for Lyme disease.
 
Dr. Lee’s question to AI: 

Regarding Sanger Sequencing of Borrelia burgdorferi….

IMR Press   2025 Jun 19

Sanger Sequencing of Borrelia burgdorferi flaB Paralogs Detected Spirochetemia at the Early Localized Stage of Lyme Disease
Sin Hang Lee
https://pubmed.ncbi.nlm.nih.gov/40613208/

-Dr Lee: “Accurate diagnosis of Lyme bacterial infection is the crux of the problem, which cannot be mitigated by mathematics. I asked AI to review my recent publication. Here is what AI says (I never purify any samples before PCR):”

AI Overview

Yes, you’ve identified a significant risk associated with purifying a single target DNA molecule from a pool of non-target DNA for PCR amplification:

potential loss of the very target DNA during the purification process. 

Here’s why and some considerations:

Why purification can lead to target DNA loss

-Multi-step process: DNA purification often involves multiple steps like cell lysis, binding to a matrix, washing, and elution. Each step presents an opportunity for loss, especially with extremely low quantities of starting material.
-Low input DNA: When aiming to amplify a single DNA molecule, the initial amount of target DNA is minuscule. Even small inefficiencies at each stage can result in the complete loss of the target DNA before PCR can even begin.
-Adsorption and binding inefficiencies: DNA might not bind efficiently to the purification matrix or might be lost during washing steps, especially if there are other cellular components or inhibitors present that interfere with binding.
-Mechanical shearing: Some methods involve physical disruption or manipulation, which can damage the delicate DNA molecule and render it unusable for PCR.
-Incomplete elution: The elution step, where the purified DNA is released from the matrix, might not be 100% efficient, leaving some target DNA behind.

Strategies to mitigate the risk

-Optimize purification protocols: Careful optimization of buffers, incubation times, washing steps, and elution volumes is crucial to maximize recovery.
-Use carrier RNA: Adding carrier RNA can improve the efficiency of DNA binding and recovery, particularly with low DNA concentrations.
-Successive elutions: Performing multiple elution steps can help release more of the bound DNA from the purification matrix.
-Avoid harsh methods: Consider less harsh purification techniques when working with minute quantities of DNA to minimize shearing and degradation.
-Specialized kits: Commercial kits specifically designed for low input DNA or single molecule analysis may offer improved recovery rates compared to general DNA purification kits.
-Direct amplification (where possible): In some cases, if the sample matrix is not highly inhibitory, direct amplification without extensive purification might be considered, although this increases the risk of PCR inhibition and false results.

Balancing purification and PCR inhibition

It’s a delicate balance. While purification aims to remove inhibitors that can hinder PCR, overly aggressive or inefficient purification can lead to the loss of the target itself. The choice of purification method and the level of rigor applied depend heavily on the sample type, the expected amount of target DNA, and the downstream PCR application.

Carl Tuttle’s question to AI:

Did Dr Mark Klempner purify samples before PCR in his NIH funded antibiotic treatment trials for Lyme disease?

AI Overview

In a study co-authored by Dr. Mark Klempner, researchers purified PCR products using a commercial kit for sequencing and analysis

Specifically:

PCR products were purified using the QIAquick PCR purification kit (Qiagen) according to the manufacturer’s instructions.
The purified samples were then eluted twice, and the eluates were pooled and sequenced.

Dr. Klempner,

Here are your PCR results from those NIH funded treatment trials: (ZERO POSITIVES!!)

[359 PCR tests with zero positives] Personal Dropbox storage area

https://www.dropbox.com/scl/fi/wlt03jb03gdu5whj89tfe/Klempner-PCR-Results.jpg?rlkey=jtobbpx9x5szyf0p5ttra0igf&dl=0

-Dr. Lee: To increase the chances of detecting single copy of Borrelia burfdorferi chromosome (or Osp A gene in a linear plasmid as Klempner et al did) in a specimen, pre-PCR purification risks losing the target DNA. Here is why according to AI (as Klempner et al did)

AI Overview
 
When working with low quantities of DNA, especially when purifying a few molecules, silica-membrane-based DNA purification kits can indeed lead to DNA loss

Reasons for DNA loss

-Inefficient binding: While DNA binds to silica in the presence of chaotropic salts, at very low concentrations, not all DNA molecules may efficiently bind to the silica membrane.
-Inefficient elution: Eluting DNA from silica can also be inefficient, especially for larger DNA fragments or supercoiled DNA, which bind more tightly to the column’s matrix.
-Low elution volume: Using a low elution buffer volume can also reduce the final DNA yield.

-Dr Lee: “The biggest flaw in Klempner et al.’s NEJM 2001 publication is the following statement:”

Base-line specimens of cerebrospinal fluid and plasma specimens obtained at base line and on days 3, 5, 21, and 45 were tested by PCR for the presence of B. burgdorferi DNA, as previously described. [21]

-Dr Lee: In the Results section, they claimed that they found no BB DNA in the blood of the patients.

They should have known that there is a big difference between blood and plasma. In medicine, plasma is the supernatant of the unclotted whole blood (containing anticoagulants) after centrifugation to spin down the RBCs, WBCs and platelets. Since the authors are experts in Lyme disease, they should have known how Borrelia burgdorferi cells distribute in the blood fractions when being centrifuged. For example, even the Google AI clearly stated the following:

 AI Overview

1. Yes, it’s generally understood that Borrelia (the bacterium that causes Lyme disease) is significantly heavier than platelets.

AI Overview

2. Studies have shown that when Borrelia burgdorferi (the bacterium that causes Lyme disease) is introduced into whole blood, it tends to concentrate within the platelet fraction. This suggests that Borrelia may have a similar sedimentation rate to platelets, or that it associates with platelets during the sedimentation process.

Here’s a closer look at what we know about the sedimentation rates of platelets and Borrelia:

Platelet sedimentation

-Antisedimentation: Interestingly, platelets don’t actually “sediment” in the traditional sense of settling downwards in response to gravity. Instead, they float on top of the blood column, a phenomenon known as antisedimentation.

-Dr Lee: “The bottom line is that Klempner lost all the Borrelia cells, if any, in the blood specimens before he started his PCR that obviously generated false-negative results.”

So, Dr. Klempner…. It appears that my original assessment was correct and your methodology was fatally flawed as suspected. Let me remind you that as an NIH funded author, you have a moral obligation to acknowledge mistakes which ultimately set the stage for long-term treatment denial.

A response to this inquiry is requested,

Carl Tuttle
Independent Researcher
Hudson, NH

2018 Inquiry to Dr. Klempner…..

 ———- Original Message ———-
From: Carl Tuttle [mailto:runagain@comcast.net]
Sent: Friday, April 27, 2018 7:54 AM
To: mark.klempner@umassmed.edu
Cc: michael.collins@umassmed.edu; ddutko@hanszenlaporte.com; ryan.kantor@usdoj.gov; michelle.seltzer@usdoj.gov; william.rinner@usdoj.gov; makan.delrahim@usdoj.gov; Tick-Borne Disease Working Group (OS/OASH); Elias, John; officeofthechancellor@umassmed.edu
Subject: Persistent Borrelia Infection in Patients with Ongoing Symptoms of Lyme Disease

April 27, 2018

University of Massachusetts Medical School
55 Lake Avenue North
Worcester, Massachusetts 01655
Attn: Mark S. Klempner, MD, Executive Vice Chancellor, MassBiologics

Dr. Klempner,

I would like to call attention to the attached study recently identifying chronic Lyme disease in twelve patients from Canada.
 
Persistent Borrelia Infection in Patients with Ongoing Symptoms of Lyme Disease
http://www.mdpi.com/2227-9032/6/2/33

All of these patients were culture positive for infection (genital secretions, skin “Morgellons” and blood) even after multiple years on antibiotics so there was no relief from current antimicrobials. Some of these patients had taken as many as eleven different types of antibiotics.

In contrast, your 2001 antibiotic treatment study found; “no evidence of B. burgdorferi in a total of more than 700 different blood and cerebrospinal fluid samples from the 129 patients in these studies.”

Two Controlled Trials of Antibiotic Treatment in Patients with Persistent Symptoms and a History of Lyme Disease
http://www.nejm.org/doi/full/10.1056/NEJM200107123450202#article_references#t=reference

Not a single positive Dr. Klempner? Doesn’t this statistically prove that your methodology was fatally flawed?

Did you culture skin and genital secretions as the Middelveen paper reports? It would appear that you conveniently stopped looking after your results supported the existing thirty year dogma; chronic Lyme does not exist.

Persistent Lyme disease is not new and has been intentionally/deceitfully suppressed for decades as described in the Vicki Logan case identified in the following letter to past CDC Director Barbara Fitzgerald:

https://www.dropbox.com/s/xaul84dqmqgbre0/Brenda%20Fitzgerald%20MD%20Director%20CDC.docx?dl=0

In 1991 B. burgdorferi had been isolated in culture from Vicki Logan’s CSF (CDC’s laboratory in Fort Collins CO.) despite prior treatment with 21 days of IV cefotaxime and 4 months of oral minocycline.

The dishonest science here in the U.S. has denied chronic Lyme which stifled research to find a curative approach. Now the rest of the world is suffering.

We have lost nearly four decades to this 21st century plague due to the racketeering scheme identified in the RICO lawsuit filed by SHRADER & ASSOCIATES, LLP against the Infectious Disease Society of America, seven IDSA Panelists and eight insurance companies. The U.S. Centers for Disease Control has aligned itself with the seven IDSA Panelists identified in this lawsuit.

Court Document:
https://www.courthousenews.com/wp-content/uploads/2017/11/LymeDisease.pdf

Lyme is an incurable disease when not treated immediately which is spreading across North America and deceitfully misclassified as a low-risk and non-urgent health issue. Patient experience is describing a disease that is destroying lives, ending careers, causing death and disability while leaving victims in financial ruin. Current antimicrobials are ineffective for eradicating all forms of the Borrelia spirochete.

Public outcry has been ignored for decades while the Centers for Disease Control sat on evidence that this infection was not easily treated with a one size fits all treatment approach as dictated by the Infectious Diseases Society of America.

Once again your studies were fatally flawed while supporting the controlling dogma leaving hundreds of thousands if not millions worldwide with a persistent infection and absolutely no relief. We have another AIDS on our hands.

Carl Tuttle
Independent Researcher
Lyme Endemic Hudson, NH

Cc: -Michael F. Collins, Chancellor

-The Tick Borne Disease Working Group

-US Department of Justice

-Daniel R. Dutko, HANSZEN LAPORTE

_______________

**Comment**

When will we learn that PCR can be manipulated a million different ways?

For more:

Category:

Activism, Lyme, research, Testing

Chronic Lyme Disease Epidemic Spreading Throughout US

https://millennialmagazine.com/2019/06/20/the-chronic-lyme-disease-epidemic/

Chronic Lyme Disease Epidemic Spreading Throughout US

Kyle Jenkins
March 24, 2025
Article Excerpts:

Due to the unreliability of most lab testing, the CDC has advised that the optimal Lyme Disease test is to have a physician conduct a clinical diagnosis based on a patient’s symptoms. If you decide to seek a physician for Lyme Disease testing, it’s important to locate an infectious diseases doctor, optimally an LLMD (Lyme Literate Medical Doctor) such as Dr. Horowitz or Dr. Jemsek. When determining a positive or negative test for Lyme Disease, Dr. Jemsek specifically focuses on a patient’s symptoms, their resistance to prior treatments and the response to antibiotic therapy.

Aside from seeing an established LLMD, the best thing a Lyme patient can do is to immerse themselves into the Lyme Disease community. The National Capital Lyme Disease Association, led by Executive Director and Lyme Disease activist Monte Skall, is an excellent resource that provides information about Lyme disease prevention, its controversial place in modern medicine and relevant ongoing research. Facebook is also an invaluable means of connecting to other Lyme patients, learning from their experiences and sharing with them your own experiences. After all, when we’re confronted by a seemingly insurmountable obstacle, we can get by with a little help from our friends. (See link for article and video)

_____________

**Comment**

I’m pleased to report that this is one of the most balanced pieces I’ve read on the topic to date.  And that’s saying something!

The embedded CNN video also shows both sides of the Lyme controversy and actually starts out with entomologist Kerry Clark who has done Lymeland a huge service by proving Lyme disease exists in the South, despite what the CDC and IDSA say.

Completely in denial, Dr. Paul Auwaerter of Johns Hopkins states that although deer ticks exist down South and even carry the Lyme bacteria, they simply don’t bite people down South.

Yeah, right.
It’s truly humorous how far these people will go to push the accepted narrative.
  • Sadly the video pushes the ‘climate change’ narrative – which independent research has proven to be a mute point regarding tick and Lyme disease proliferation.
  • It also pushes the faulty notion that only 10-20% go on to suffer long-term symptoms, when it’s actually 40-60% when those who are diagnosed and treated late are included.
  • Further, Auwaerter regurgitates the ancient Klempner study as ‘proof’ long-term antibiotics don’t work, despite the fact the trial was stopped after only 90 days.  According to Lyme advocate and patient, Carl Tuttle, Klempner’s methodology is fatally flawed in the two NIH studies that set the stage for treatment denial, and that there are over 360 references concluding the exact opposite of Klempner’s findings.
    • Tuttle spoke with Dr. Sin Hang Lee of Milford Molecular Diagnostics Lab about the fact there is significant risk associated with purifying a single target DNA molecule from a pool of non-target DNA for PCR amplification, because it could potentially lose the very target DNA during the purification process.  This would completely strike at the heart of the Klempner study.
  • Then the video states that although some patients do have real symptoms they are caused by nerve damage and not infection.  Thankfully the video mentions there are others who disagree.
On balance even the CNN video attempts to be fair, however, public health officials are truly beginning to look like they are completely out of touch with reality and refuse to listen to any logic, reason, or facts.

Category:

Activism, Lyme, research, Testing, Ticks

When Lyme Is Not Lyme: CDC and FDA Policies and Medical Practice Must Be Refined to Embrace Complexities For the Good of the Patient

https://popularrationalism.substack.com/p/when-lyme-is-not-lyme-cdc-and-fda?

When Lyme Is Not Lyme: CDC and FDA Policies and Medical Practice Must Be Refined to Embrace Complexities For the Good of the Patient

Here I propose a decision-tree based differential diagnosis of Lyme and Not Lyme. It’s a start.

James Lyons-Weiler, PhD
Aug 07, 2025

In the realm of infectious disease, simplicity is seductive. It promises clear diagnoses, standardized protocols, and neat narratives. But Lyme disease—a condition with protean manifestations, shifting microbial profiles, and diagnostic challenges at every stage—refuses to conform. It insists on complexity. And in response, our institutions—particularly the CDC and FDA—have built a regime of policies that actively deny it.

The result? A generation of patients misdiagnosed, underdiagnosed, or dismissed entirely—not because they lack illness, but because the illness they carry doesn’t fit the model. The model is wrong.

This article argues that regulatory science has reached a breaking point in Lyme disease policy. The failure to recognize nuanced diagnostic tools—especially direct detection technologies like PCR and sequencing—and the overreliance on antibody-based serologic paradigms are not only outdated, they are dangerous. The bucket-labeling of chronic illness under the guise of “post-treatment Lyme disease syndrome” or “functional somatic disorder” is not science. It is avoidance. It is bureaucracy masquerading as epidemiology.

We can—and must—do better.

The Tidy Algorithm That Misses the Patient

The CDC continues to recommend a two-tier serologic testing algorithm for Lyme disease diagnosis: an initial ELISA (enzyme-linked immunosorbent assay) or IFA (indirect fluorescent antibody), followed by a Western blot. But this cascade is built around the immune system’s delayed humoral response—one that may take weeks to develop and varies wildly across individuals.

Early localized Lyme disease—the phase where diagnosis and treatment are most crucial—often produces negative antibody tests despite active spirochetemia. The immune system hasn’t had time to respond, or responds atypically. Yet this window is precisely when patients present with acute symptoms—rash, fatigue, fever, malaise—and need confirmation.

Instead, they are sent home with instructions to “wait for antibodies to develop.” It is a ritual of deferred care masquerading as prudence.

Meanwhile, molecular techniques—such as PCR amplification of bacterial chromosomal DNA followed by Sanger sequencing—can detect Borrelia burgdorferi spirochetes in the blood of these patients with precision, even at very low organismal loads. A 2024 study confirmed the utility of the flaB gene as a sensitive target for direct molecular detection. And yet, CDC officials such as Dr. Christina Nelson continue to state—without qualification—that PCR is “not useful” in the diagnosis of Lyme disease, a systemic infectious disease. This “policy statement” on Lyme diagnosis contradicts CDC’s own established protocols for infectious diseases. For example, the CDC’s diagnostic protocol for SARS-CoV-1 in 2003 recommended using three specific primers to perform heminested PCR to amplify a 348-bp genomic cDNA for sequencing “to verify the authenticity of the amplified product” The CDC scientists also used Sanger sequencing of the nested PCR products to help diagnose the first SARS-CoV-2 case in this country.

The CDC does not recommend the Widal (serologic) test for diagnosing typhoid fever, a classic bacterial systemic infectious disease, which is usually diagnosed by blood cultures.

This is not simply a matter of differing interpretations. It is institutional self-contradiction, plain and harmful. On one hand, CDC acknowledges the superiority of molecular methods in select studies. On the other, its public guidance to clinicians categorically dismisses them. The result is diagnostic nihilism, not progress.

The Adjudicated Endpoint Mirage

This failure to adopt precise diagnostics bleeds into vaccine trials—most recently, those for Pfizer and Valneva’s VLA15, a candidate Lyme vaccine. The protocol allows for adjudication committees—not direct evidence—to determine whether a patient “truly” had Lyme disease based on serologic conversion.

In other words, the gold standard is not evidence of infection, but whether enough bureaucrats agree that a positive Western blot means what they want it to mean. This is a scientific sleight-of-hand: dressing bias in the costume of consensus.

We don’t adjudicate cancer diagnoses this way. We don’t require panels to decide if a culture grows MRSA. Why do we treat Lyme disease differently?

Because the system was designed around patented serologic tools, and because acknowledging more sensitive direct tests would expose three decades of flawed public health doctrine. The regulatory apparatus has become self-protective. It resists admitting new knowledge, even when it emerges from the very labs it funds.

The Individual’s Diagnostic Pathway: A Vanishing Art

Modern medicine must reclaim a lost art: tracing the pathway of illness in the individual patient. Lyme disease—and other stealth infections—do not conform to static models. They unfold dynamically, in stages, with overlapping presentations. Co-infections with Babesia, Bartonella, Ehrlichia, or Rickettsia are common and further blur the clinical picture. Immune exhaustion, biofilm states, immune complex sequestration—none of these phenomena are accounted for in the serologic testing regime.

And yet the CDC’s official diagnostic flowchart is oblivious to all of it.

This is not a technical problem. It is a philosophical one. To see illness clearly, one must be willing to dwell in ambiguity. To build robust diagnostics, one must test them against reality—not against regulatory convenience.

When a patient walks into a clinic with chronic fatigue, joint pain, or neurological complaints, physicians now reflexively reach for either a psychiatric label or a “fibromyalgia” diagnosis if the serology is negative. This is not differential diagnosis. It is abdication. And it is rooted in federal guidance that refuses to update.

A Better Framework: Evidence, Not Adjudication

It is not difficult to build a better system. We start by acknowledging that direct detection methods—when confirmed via sequencing—constitute definitive evidence of infection. A PCR test that amplifies Borrelia DNA and confirms identity through Sanger sequencing is objective, reproducible, and not susceptible to interpretive bias. Unlike a Western blot, there is no subjectivity in band intensity or background noise.

CDC must formally revise the case definition of Lyme disease to admit these tools. It must publish updated MMWRs and notify CLIA-certified labs that sequence-confirmed molecular diagnostics are not just permitted—they are necessary. And FDA, for its part, must refuse to approve any vaccine for Lyme disease that does not use culture-positive or sequencing-positive endpoints in its efficacy trials.

The adjudication committee must go the way of the phlogiston theory. It is an epistemic relic.

The Stakes: Chronic Illness Mismanagement on a National Scale

When Lyme is misdiagnosed, the result is not just diagnostic error. It is years of compounded harm—neurological decline, systemic inflammation, misprescribed psychiatric drugs, and social marginalization. And when regulators misdefine illness, insurance companies follow suit, refusing reimbursement for testing or treatment that strays from the flawed algorithm.

Thus, a person with real infection is told they are imagining it, or “have something else.” They are sent to psychiatrists, subjected to medications they don’t need, and denied the very antibiotic or herbal therapies that could help them.

This is not merely negligence. It is institutionalized medical error.

And the cost is not just individual. It is civilizational. When truth is buried beneath layers of bureaucratic adherence, science becomes theater.

Complexity Is Not the Enemy

To fix Lyme disease policy, we must abandon the false comfort of simplicity. Illness is not simple. Infection is not static. Patients are not algorithms.

The CDC and FDA must evolve to meet the complexity of this pathogen. And physicians must be permitted—indeed encouraged—to follow the diagnostic trail wherever it leads, even if that means sequencing a pathogen the government pretends not to see or looking for autoimmunity due to pathogenic priming from aluminum-containing vaccines that mimics Lyme.

In the end, it is not Borrelia burgdorferi that threatens public health the most. It is the system that refuses to learn from its past, revise its models, or admit that sometimes… Lyme is not just Lyme.  (See link for article)

_______________

For more:

Category:

Activism, Lyme, Testing, Treatment