Archive for the ‘Testing’ Category

Not Good: Medscape – New Federal Oversight of Lab Developed Tests

The following information about “FDA approved” tests is a perfect example of corrupt government agencies doing what they do best: monopolize and control disease for their own purposes – usually financial.

They have restricted doctor and patient choice, care, and access in a number of ways, but one way they cling to like a survivor on a raft is testing. Lyme testing has been fraudulent from the get-go and their suppression of other tests is something that should be made into a movie.  In so many ways the CDC and FDA are maniacal evil twins – both doing all within their power to monopolize medicine.

Dr. Sin Hang Lee has sued the CDC for suppressing direct detection tests for Lyme disease, and promoting their own newly patented, unproven metabolomics technology for diagnosis of LD. Current and former CDC representatives receive royalties as a result of working on the approval and promotion/CDC endorsement of a Lyme disease serology test.

Lee has been fighting back with equal tenacity and performed independent research on faulty COVID testing which showed COVID cases will be overstated by a factor of 72%!

Instead of fixing the obvious errors (no positive control sample, no data on false positives, faulty cycle thresholds, and refusal to publish Ct values due to it being “proprietary”,) HHS, FDA, and CDC opted for arbitrary and perpetual diagnosis of COVID.

It’s important the CDC and FDA control testing because then they can completely steer the narrative about any disease – even if the numbers are all based on faulty testing.  They’ve been doing this in Lymeland for over 40 years by

“setting arbitrary level of antibodies to diagnose a disease that has not been amenable to Koch’s postulates seems open to question.  By the same token, ignoring antibody results unless they meet arbitrary levels seems suspect.  The vast majority of patients in this series showed some WB antibody exposure, but many did not meet the arbitrary limits set….in our present state of knowledge, the diagnosis of chronic Lyme disease is a clinical one.  Many of the patients in this series have suffered serious ‘hurts’ when they have been told that they could not have LD because their WB did not meet arbitrary limits.”  ~ Dr. Burton Waisbren  IDSA founder who disagreed with his colleagues.  RIP

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/  Video within link (Approx. 10 Min)

Medscape: New Federal Oversight of Lab Developed Tests

Carl Tuttle

Hudson, NH, United States

NOV 1, 2023 — 

Please see the following inquiry sent to Dr. Paul Auwaerter regarding his commentary (verbal diarrhea) published on Medscape.  He has yet to respond to my serious question. Why not email Dr. Auwaerter and demand a response?

Auwaerter’s image was found on his Hopkins profile page:
https://www.hopkinsmedicine.org/profiles/details/paul-auwaerter

———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: “pauwaert@jhmi.edu” <pauwaert@jhmi.edu>, “pgauwaerter@gmail.com” <pgauwaerter@gmail.com>
Cc: “aaguilar@webmd.net” <aaguilar@webmd.net>, “DFlapan@Medscape.net” <DFlapan@Medscape.net>, “lkane@medscape.net” <lkane@medscape.net>, “gamiller@medscape.net” <gamiller@medscape.net>, “dolmos@webmd.net” <dolmos@webmd.net>, “sarah.wright@webmd.net” <sarah.wright@webmd.net>, “editor2@webmd.net” <editor2@webmd.net>
Date: 10/25/2023 9:51 AM EDT
Subject: Medscape: New Federal Oversight of Lab Developed Tests

Medscape COMMENTARY
 
New Federal Oversight of Lab Developed Tests
https://www.medscape.com/viewarticle/997365

Paul G. Auwaerter, MD

Excerpt:

“I often see patients who are concerned they might have Lyme disease, or they’ve been told by other physicians that they have a tickborne or multiple infections. I’ve had patients who claim to have five or six infections: Lyme disease, Babesia, Bartonella, Mycoplasma, or Epstein-Barr virus. They bring LDT results from outside laboratories, which often have a proviso that these tests are only for research or educational purposes. Yet, they purport finding analytes (antibodies or proteins) that suggest the patient has an active infection. These patients may have been treated but are not improving, so they are referred to me.”

Oct 25, 2023

The IDSA Foundation
1300 Wilson Boulevard Suite 300
Arlington, VA 22209
Attn:  Paul Auwaerter, vice chair of the IDSA Foundation

Dear Dr. Auwaerter,

As a member of New Hampshire Governor Chris Sununu’s 2020-2021 commission to study diagnostic testing for Lyme disease, I read your commentary with great interest. After a full year of deliberation, study results concluded that the FDA approved two-tier serologic immunoassay for Lyme was not reliable in all stages of disease. (No better than a coin toss)

COMMISSION TO STUDY TESTING FOR LYME AND OTHER TICK-BORNE DISEASES
https://www.gencourt.state.nh.us/statstudcomm/committees/default.aspx?id=1515

“A commission to study the role of clinical diagnosis and the limitations of serological diagnostic tests in determining the presence or absence of Lyme and other tick-borne diseases”
 
With that conclusion, serology cannot be used to determine who has or does not have Lyme disease.

“FDA approval” (Federal Oversight) has failed miserably in this example.

The CDC has warned the medical community that “surveillance case definitions” (which include the IgM and IgG Western blot serologic bands) are not to be used for making a clinical diagnosis:

From the CDC website:

Lyme Disease (Borrelia burgdorferi)
2022 Case Definition
https://ndc.services.cdc.gov/case-definitions/lyme-disease-2022/

NOTE: A surveillance case definition is a set of uniform criteria used to define a disease for public health surveillance. Surveillance case definitions enable public health officials to classify and count cases consistently across reporting jurisdictions. Surveillance case definitions are not intended to be used by healthcare providers for making a clinical diagnosis or determining how to meet an individual patient’s health needs.
________________________

Recent announcements:

1. “Standard” Lyme testing once again proves fatal
https://www.lymedisease.org/lyme-testing-proves-fatal/

“Lyme disease helped kill our son. A better test might have saved him.”

2. Sensitivity of Two-Tiered Lyme Disease Serology in Children with an Erythema Migrans Lesion 
https://doi.org/10.1093/jpids/piad073

Abstract

In our prospective cohort of 192 children with a physician-diagnosed erythema migrans (EM) lesion, two-tier Lyme disease serology had higher sensitivity in children with multiple EM lesions (76.8% multiple lesions vs. 38.1% single EM; difference 38.7%, 95% CI 24.8 to 50.4%). The diagnosis of cutaneous Lyme disease should be based on careful physical examination rather than laboratory testing.

3. Jury awards $6.5M to Maine family for wrongful death, negligent misdiagnosis
https://fox23maine.com/news/local/jury-awards-65m-to-maine-family-for-wrongful-death-negligent-misdiagnosis-mercy-hospital-dr-john-henson-peter-smith-lyme-disease-lyme-carditis-physicians

Court records show Dr. Henson diagnosed smith with a skin disorder and a virus, writing “no sign of Lyme Disease.” Smith died of Lyme carditis.

(I understand that serology was NEGATIVE in this case)

Question:

Dr. Auwaerter…  I would like to call attention to the following 2009 tick study conducted here in New Hampshire:

Correlation between Tick Density and Pathogen Endemicity, New Hampshire
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2671416/

The study found deer ticks were carrying multiple pathogens (co-infections) that could be transmitted in a single bite.

What FDA approved Tick-Borne Disease Panel are you recommending so as not to miss any of these infections?

A response to this inquiry is requested
Carl Tuttle
Hudson, NH

Cc: MEDSCAPE EDITORIAL STAFF

Additional reference:

“Seronegativity in Lyme borreliosis and Other Spirochetal Infections” 16 September 2003
https://www.dropbox.com/s/3d6m45jzlhhwalu/Seronegativity.pdf?dl=0

“If false results are to be feared, it is the false negative result which holds the greatest peril for the patient.”

Category:

Activism, Lyme, research, Testing

Oct. 31 Webinar: A Rash of Tickborne Illnesses: Current Challenges With Diagnostic Testing

Upcoming Webinar: A Rash of Tickborne Illnesses: Current Challenges With Diagnostic Testing

Date: Oct 31, 2023 9 a.m. PDT/12 p.m. EST

Please join us for an upcoming webinar, “A Rash of Tickborne Illnesses: Current Challenges with Diagnostic Testing,” an hour-long webinar featuring Elitza S. Theel, Ph.D., D(ABMM) and Elizabeth Lee-Lewandrowski, Ph.D.

  • Understand the incidence and prevalence of tickborne illness
  • Review the current testing methodologies available for Lyme disease
  • Explore current diagnosis guidelines for Lyme disease
  • Discuss the advantages of Point-of-Care diagnostics for Lyme disease

Go here to register:  https://gateway.on24.com/wcc/eh/3300431/lp/4379756/a-rash-of-tickborne-illnesses-current-challenges-with-diagnostic-testing

Category:

Lyme, Testing

“We Admit The Shot Has SV40, But We Found Some ‘Experts’ Who Don’t Think It’s a Problem”

If you are new to SV40, read this, and watch this.

https://kirschsubstack.com/p/ok-you-were-right-we-admit-vaccine

“OK, you were right. We admit the vaccine is contaminated with SV40, but we found some experts who think it’s not a problem.”

How is it that Kevin McKernan, and not any world health authority, found the contamination in April 2023? And why are the FDA, CDC, and the mainstream media still silent about this?

 
STEVE KIRSCH
OCT 19, 2023

Executive summary

Kevin McKernan is a friend of mine and his work is unimpeachable. His results have been replicated by others all over the world. He found that the COVID vaccines contain therapeutic levels of plasmid DNA. DNA lasts forever, and if it integrates into your genome, you will produce its product forever

The main takeaways are:

  1. The mRNA vaccines are contaminated with SV40 and who knows what else. This should never have been allowed.

  2. The vials exceeded the guidelines by “orders of magnitude.”

  3. The discovery was confirmed by Health Canada.

  4. The FDA and CDC are remaining silent. As far as anyone knows, they are no doing anything to assess the implications of the finding. I presume that they must believe that by not knowing the implications, they won’t have to disclose them so they are better protecting themselves against the public who might be very upset to learn they were guinea pigs. But that’s just an educated guess.

  5. We don’t know what the implications are. Experts disagree. Some claim the contamination is meaningless. Others say it could be very serious.

  6. The experts who claim there is no risk of harm have NO EVIDENCE to back up their claims. So that’s really comforting, isn’t it? Trust the experts :). Don’t worry.

  7. The politicians seem happy to let YOU take the risk. And they aren’t giving you any informed consent about this issue. Nobody seems to be requesting the CDC warn anyone of the potential risk. Wouldn’t want to scare anyone, would we?

  8. It was not the government regulators who first discovered the contamination. It was my friend Kevin McKernan. This should never have happened. The government should have discovered this at the very outset, 3 years ago.

  9. It would have been discovered sooner by independent researchers, but people were threatened with arrest if they supplied vials for analysis. I know this first hand because I was warned I would be arrested and criminally charged if I participated in trying to analyze the vials.

  10. We don’t fully know the ramifications of the contamination, but they probably aren’t good, and they could be devastating and irreversible. We don’t know yet because nobody has done the necessary studies.

  11. The experts I consulted thought that it was likely to be very serious. But they couldn’t quantify “likely” but said only that it was “more likely than not.”

  12. I volunteered for a full gene sequencing study, but they said they’d have to cut off my deltoid muscle, so I changed my mind.

  13. The regulators apparently never QAed any of the vials. If they did, they would have found contaminations such as this before it was ever injected into a single human being. Or they did and simply chose to remain silent and look the other way. Health Canada said the sequence was disclosed to them, but that the drug company never pointed out that the SV40 promoter sequence was specifically identified in the gene sequence provided.

  14. The SV40 promoter contamination has been known since April 9, 2023 when McKernan published a paper on it. But the CDC and FDA have remained silent on this issue. That’s comforting, isn’t it? <sarcasm off>

  15. The mainstream media is silent as well.

  16. And the mainstream medical community is silent as well. After all, they recommended you injected the stuff so they are not going to admit they f _ _ _ _ d up, are they?

  17. There is absolutely no doubt this is happening, so the silence of the formerly “trusted” health authorities is telling.

  18. The longer they delay telling you they forgot to QA the vials, the bigger the hole they are going to dig for themselves.   (See link for article and resources)

_________________
**Comment**
 
Public Health, mainstream medicine and media have used the silent treatment in Lymeland for over 40 years so I don’t hold out much hope of transparency.  These people have far too much invested in their power structure for honesty at this point.  They’ve been finding “experts” to tell them what they want to hear for so long they wouldn’t know real science if it hit them in the face.
 
In the “For more Info” section of Kirsh’s paper is an important key:

In-depth explanation from WCH and 14 minute video of Kevin McKernan. There is also a 2 minute excerpt entitled “Bait & Switch” on the page. Read this article first. Key excerpts:

  1. “By using qPCR to detect DNA but fluorometry to measure RNA, manufacturers had managed to mislead the regulators regarding the presence of DNA in the vials!”

Regarding the presence of SV40:

An NIH researcher, Bernice Eddy, found that hamsters who were injected with the Salk polio vaccine developed cancerous tumors. She was instructed not to publish her research but she did it anyway. Her lab was taken from her and she was demoted and moved to another position. Soon after her findings were corroborated and the carcinogen identified in the virus was SV-40.  The fly in the ointment is that every scientist on planet earth witnessed the treatment of Eddy and nobody wants to determine what component of SV40 is carcinogenic (can you blame them?) – so we remain ignorant, and now ‘the powers that be’ have yet another loophole to make excuses with.  The same issue is alive and well in Lymeland which is why nothing happens.

Rigging testing has always been a foundational component in corrupt public health’s playbook.  If you control the testing you control virtually the entire narrative.  

Hirsch states he is “arranging funding for a researcher with the necessary samples and equipment to do the research. This is because protecting the public is the responsibility of the public, not the government.“

And this, my friends, is the only way Lymeland will ever move forward. We must do it ourselves.

Category:

Activism, research, Testing, vaccines, Viruses

Lyme & Coinfection Update: Dr. Armin Schwarzbach

http://

An Update for Lyme & Co-infections

Dr. Armin Schwarzbach/Nordic Laboratories & dnalife

Oct. 9, 2023

Within the field of infections, new research is in constant development. During his discussion, Dr. Schwarzbach will cover both what tests he offers through Nordic and dnalife, looking at what could potentially be a great alternative to what the national health service may have to offer. He will also be informing us about new and ongoing testing and considerations, while also touching on the topic of co-infections as an additional concern for patients.

If you go to the Youtube link, you can also view the transcript.

Category:

Activism, Lyme, research, Testing

Yet Another “Unique” EM Rash

https://danielcameronmd.com/unique-presentation-em-rash/

A UNIQUE PRESENTATION OF AN EM RASH

unique-EM-rash

The rash, indicative of Lyme disease, does not always present as a classic “bull’s-eye rash,” as this case report demonstrates. A broad spectrum of lesions has been reported in patients with Lyme disease (LD). In fact, one study found only 6% of the lesions in LD patients had the “classic bull’s-eye or ring-within-a-ring pattern.” [1]

By 

In the case report, “A Non-Classical Presentation of Erythema Migrans in a 51-Year-Old Woman With Early Manifestation of Lyme Neuroborreliosis (Bannwarth Syndrome),” Lorquet et al. describe a 51-year-old female who presented with general malaise, headache, neck stiffness, and an expanding rash consistent with Lyme neuroborreliosis.2

The woman reported having a worsening of her symptoms over a 4-day period and a rash which expanded on her upper back but she did not recall any tick bites.

“She stated that [the rash] started as a small area of redness, spreading rapidly,” the authors wrote.

Clinicians suspected she might have cellulitis and prescribed cephalexin and valacyclovir. But her symptoms did not improve.

“The “bull’s-eye” appearance of erythema migrans is not the only cutaneous manifestation of the acute stage of Lyme disease. There can be multiple variations of the rash, as demonstrated in the patient.”

According to the patient, “the rash had gotten larger and more pruritic [itchy] and that her headache had become more severe, also causing severe pain that radiated to the right side of her neck,” the authors wrote.

The erythema migrans (EM) rash covered two-thirds of her back and had a 5 cm crusted plaque in the center. There was a second circular rash that appeared, as well, behind the woman’s right ear.

READ: The many presentations of the Lyme disease rash

Clinicians treated her symptoms with intravenous ondansetron, ketorolac, pantoprazole, and saline. But also empirically treated for Lyme disease with doxycycline.

After Lyme disease testing was positive, the woman was diagnosed with Lyme Neuroborreliosis, also known as Bannwarth syndrome in Europe.

Bannwarth syndrome (BS) is a typical manifestation of early Lyme neuroborreliosis (LNB) in Europe. It is characterized by painful radiculopathy, neuropathy, varying degrees of motor weakness and facial nerve palsy, and cerebrospinal fluid (CSF) lymphocytic pleocytosis.3

“Several weeks later, the patient had made a full recovery and was back to her baseline level of functioning,” the authors wrote.

They point out, “The “bull’s-eye” appearance of erythema migrans is not the only cutaneous manifestation of the acute stage of Lyme disease. There can be multiple variations of the rash, as demonstrated in the patient.”

Related Articles:

Single dose of doxycycline for treatment of tick bite only prevents a Lyme disease rash

Erythema migrans rash doesn’t always have a bull’s-eye appearance

Lyme disease mimics cellulitis skin infection

References:
  1. Schotthoefer A M, Green C B, Dempsey G, et al. (October 25, 2022) The Spectrum of Erythema Migrans in Early Lyme Disease: Can We Improve Its Recognition? Cureus 14(10): e30673. doi:10.7759/cureus.30673
  2. Lorquet JR, Pell R, Adams J, Tak M, Ganti L. A Non-Classical Presentation of Erythema Migrans in a 51-Year-Old Woman With Early Manifestation of Lyme Neuroborreliosis (Bannwarth Syndrome). Cureus. 2023 Jun 4;15(6):e39931. doi: 10.7759/cureus.39931. PMID: 37416051; PMCID: PMC10319937.
  3. Shah A, O’Horo JC, Wilson JW, Granger D, Theel ES. An Unusual Cluster of Neuroinvasive Lyme Disease Cases Presenting With Bannwarth Syndrome in the Midwest United States. Open Forum Infect Dis. 2017 Dec 23;5(1):ofx276. doi: 10.1093/ofid/ofx276. PMID: 29383323; PMCID: PMC5777478.

______________

**Comment**

So many thoughts here.

  • The rash issue has caused frequent, unnecessary delays in diagnosis and treatment as doctors are not properly educated on actual science, but have been fed a CDC-narrative.  Most doctors are unaware that this rash is diagnostic for Lyme disease, and that misdiagnosis can have fatal consequences.
  • Aucott reports that 54% of Lyme disease patients who present without a rash are misdiagnosed.
  • The designation of Bannwarth Syndrome is also confusing and has caused massive misdirection.  The symptoms are nearly synonymous with most cases of Lyme & can cause severe burning, stabbing, biting, or tearing pain & responds poorly to analgesics:
    • radicular pain (100%)
    • sleep disturbances (75.3%)
    • headache (46.8%)
    • fatigue (44.2%)
    • malaise (39%)
    • paresthesia (32.5%)
    • peripheral nerve palsy (36.4%)
    • meningeal signs (19.5%)
    • paresis (7.8%)
  • This case study shows many of the problems that continue on unabated in Lymeland.

Category:

Lyme, research, Testing, Treatment