Archive for the ‘Testing’ Category

PCR Proven An Unmitigated Disaster: Italy Reduces its COVID-19 Death Number by 97%. We Tried to Warn You

https://popularrationalism.substack.com/p/pcr-proven-an-unmitigated-disaster

PCR Proven An Unmitigated Disaster: Italy Reduces its COVID-19 Death Number by 97%. We Tried to Warn You.

The US is hellbent toward chronic worklosses of historic proportions.

James Lyons Weiler

Nov. 2, 2021

Since March, 2020, I’ve been sounding the alarm on the misuse of PCR test results as a proxy for a diagnosis of COVID-19, the disease caused by a SARS-CoV-2 infection. Based on first principles, it was clear to me then that the false positive rate of PCR conducted at high cycle threshold values would lead to far more false positive than true positive test results, leading to the lockdown that eventually happened.

OSHA is about to drop a rule that requires employees in companies with more than 100 workers to submit to a vaccination, or to tested and to mask in the workplace – and there will undoubtedly be a fourth wave when people start testing en masse.

Now, due to the realization that the “died with = died from” paradigm is dependent on the accuracy of the “with” part – which depends largely on PCR test kits. Given the use of high threshold values for “diagnosis” of COVID-19, the rates of cases and deaths have been grossly exaggerated. The evidence is so overwhelming – and coming in from all sources (except the US CDC) that Italy has revised its estimated number of deaths from COVID-19 from over 390,000 to less than 4,000 – overnight.

This means the US is poised for mayhem and chaos.

Fact checkers criticized IPAK for publishing information on the utterly flawed paradigm – and they were proven wrong.

Now, unless OSHA backs down from requiring vaccination or testing, which of course presumes:

  1. the safety of the vaccine (very much in question)
  2. that only unvaccinated persons can spread COVID-19 in the workplace (absolutely false)
  3. that routine, repeated, widespread asymptomatic testing won’t lead to a flood of chronic false positives (impossible)

The OSHA rule will lead to workloss at companies that follow their directive – and the worklosses will be of historic proportion.

Dr. Sin Hang Lee, MD points out that this is not the first time reliance on PCR test results as a proxy for medical diagnosis has led to disastrous results.

Mark Schiffman of the NCI on PCR HPV testing, which leads to >95% unnecessary colposcopic biopsies on hundreds of thousands of healthy women each year.  Lee pointed out (personal communication) this passage from Schiffman and colleague:

Most HPV infections are benign, and over-reacting clinically to HPV positivity can cause psychological and possible iatrogenic physical (e.g., obstetrical) harm. We describe the built-in false positives in current tests, and the real harm that can result when the meaning of such false positive HPV tests is misunderstood. We suggest steps that could reduce harm being done by flawed tests and excessive clinical responses to positive HPV testing.

We’re already poised for hyperinflation due to the harmful effects of the repeated stimulus payments based on printed money. When the economic shit hits the fan due to worklosses across the companies, well, I tried. Again, I’ve been at this since March, 2020, and others quickly followed suit. It is with no pleasure that I report to the skeptics: We tried to warn you.

I cannot convey the urgency with which we all must act to stop the OSHA rule from dropping. CALL YOUR SENATORS NOW.

_________________

**Comment**

I don’t need to tell Lyme/MSIDS patients that testing has worked in the reverse for tick-borne illness.  While false-positives are extremely high for COVID and HPV, testing for Lyme and coinfections is nearly always negative, an injustice that’s been going on for over 40 years and shows no sign of changing.  Further, the CDC has actively suppressed more accurate testing, and one researcher is suing it for using its regulatory power to block widespread application of a highly reliable direct DNA test and for channeling public funds to promote its own patented, but immature indirect metabolomics technology for Lyme disease diagnosis, a technology known to be prone to false positives.

For more on mortality:

For more on testing:

Lyme Disease Advocacy Organization Meets With FDA

Press_Release_-_October_2021

LYME DISEASE ADVOCACY ORGANIZATION MEETS WITH FDA


BOSTON, MA (October 25, 2021) — Nonprofit grassroots organization TruthCures met with Food & Drug Administration (FDA) officials last week to discuss issues related to notoriously inaccurate Lyme disease diagnostic tests. The group’s executive director, Laura Hovind, and associate Lahra Tillman were joined by Carl Tuttle, an appointee to New Hampshire Governor John Sununu’s Lyme Disease Study Commission, and their legal counsel, a former federal prosecutor. Kenneth Liegner, M.D., a longtime treating physician, published author and renowned Lyme disease expert participated remotely to demonstrate the deficiencies of the Lyme disease diagnostic method and the harm it does to patients.


At issue are 27 years worth of FDA-cleared Lyme disease diagnostic tests. Lyme disease is a bacterial illness caused by the bite of an infected tick. TruthCures claims the diagnostics are wholly inadequate because they are designed to detect only a small minority of cases predisposed to developing “Lyme arthritis,” a less-severe manifestation of the disease. They cited published literature and historical federal meeting documents that indicate the sicker Lyme disease cases are immunosuppressed and rarely test positive by the criteria that have been in place for nearly three decades.


“We are extremely pleased with the FDA’s response so far and are encouraged by how quickly they understood the problem and began thinking of solutions available to them within the regulatory framework,” said Tillman.


In a detailed presentation, the group explained how Lyme disease researchers’ financial interests in patents for the various bacterial components of diagnostic tests and vaccines have been prioritized over public health. They also shared results of an independent analysis by a diagnostics regulatory expert indicating there may have been irregularities with the process by which Lyme disease diagnostic tests were relabeled in the late 1990s. “We are very concerned that patients were left out of the equation when changes were made to the testing protocol,” said Hovind.


The group requested the FDA’s assistance in investigating the manipulated diagnostic protocol and its far-reaching effects, as well as coordinating with other agencies to evaluate related accepted standards they claim are inadequate. “As a public servant myself, I applaud the FDA investigators’ efforts to understand and act on information provided by concerned citizens,” noted Amy Kissinger, a member of TruthCures’ board of directors. “We are confident in their dedication to do the right thing in terms of the regulatory component of our claims.”

Added Hovind, “Our goal has always been to expose the truth and clear the way for accurate tests so the millions suffering this devastating disease can get the diagnosis and treatment they need. This development should give them hope that someone is striking at the root of the problem, and change is on the way.”

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TruthCures is a registered 501(c)3 nonprofit organization dedicated to restoring a valid case definition for Lyme disease so all affected people can be accurately diagnosed and successfully treated. For more information, visit truthcures.org or email truth@truthcures.org.

Final Remarks to the NH Lyme Disease Study Commission

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

Final Remarks to the NH Lyme Disease Study Commission

Carl Tuttle

Hudson, NH, United States

Oct 9, 2021 — 

Please see my final statement below from the last meeting held Oct 4, 2021.

Our study commission has concluded with a final report to be sent to the Governor within the next few weeks which will be distributed to the public and medical community. I will be posting a copy of that report here on this petition site.

The Commission’s focus was on the diagnostic tests:
http://gencourt.state.nh.us/legislation/2020/HB0490.html

RSA 141-C:6-a, relative to a commission to study the use and limitations of serological diagnostic tests to determine the presence or absence of Lyme and other tick-borne diseases and the development of appropriate methods to educate physicians and the public with respect to the inconclusive nature of prevailing test methods.”

Final Remarks to the NH Lyme Disease Study Commission

———- Original Message ———-

From: CARL TUTTLE <runagain@comcast.net>
To: Leah Cushman <Leah.Cushman@leg.state.nh.us, Jerry Knirk <Jerry.Knirk@leg.state.nh.us>, Tom Sherman <Tom.Sherman@leg.state.nh.us>, Jeb Bradley <Jeb.Bradley@leg.state.nh.us>,
Cc: All members of the NH Lyme Disease Study Commission
Date: 10/06/2021 9:42 AM
Subject: Corrected Final Statement for the Lyme Disease Study Commission

To the Lyme Study Commission Members,

Please see the corrections below to my final statement which was read at our last meeting.

Carl Tuttle’s closing remarks:

Over the course of this Study Commission, we have heard from numerous front-line treating physicians across the country who have treated thousands of Lyme patients. These physicians all agree that serology is unreliable and a negative test result does not rule out Lyme disease.

Dr. Horowitz published a study of 200 late-stage chronic Lyme patients and found that these patients were IgM positive but had negative IgG results on their Western blots. [1] Johns Hopkins published similar results in 2015. [2]

During the Dearborn Conference in 1990 (Known as Dearborn 1) the following statement was recorded by Rahn & Malawista of Yale University:

“In some patients, the IgM antibody level remains elevated for many months or IgM antibody reappears late in illness; these phenomena predict continued infection.”

During the Dearborn Conference in 1994 (Known as Dearborn 2) the following case definition was established to support vaccine development:

“IgM WB is considered positive when at least two of the following three bands are present: 24 kilodalton (kDa) outer surface protein C (OspC)*, 39 kDa basic membrane protein A (BmpA), and 41 kDa (Fla). ***Disregard IgM results for specimens collected >30 days after symptom onset.”***

Dr. Donta who has also treated thousands of patients has found that those who have a reaction to band 23 for example which is OsPC (highly specific to Borrelia) and also reactions to the less specific band 41 which represents the spirochete’s flagella are markers for active infection without meeting the CDC case definition.

I decided to put this newfound information to test and asked patients who testified on Aug 23rd to send me copies of their Western blots.

Kim Parker had a fully positive IgM result with 3 out of 3 positive CDC bands but no IgG bands whatsoever. Her test results match the Dearborn 1 Conference conclusion which was tossed out in 1994.

Ashley Lynch who testified from her wheelchair had reactions to band 31 OsPA (highly specific to Borrelia) along with band 41. Similar to what Dr. Donta had pointed out.

My wife’s Western blot had only two positive bands, once again 23 and 41 as Dr. Donta has mentioned.

As Laura Hovind pointed out in her testimony and supporting documentation, [3] the sickest of the Lyme patient population do not produce a robust immune response as those with the swollen knee presentation (Allen Steere disease) This was reiterated by Dr. Raymond Dattwyler of SUNY-Stonybrook during the FDA’s Vaccines and Related Biologics Product Advisory Committee [4] a few months prior to Dearborn 2 in 1994. Despite knowing this, the CDC went along with the case definition that we are stuck with to this day which was sanctioned by the Association of Public Health Laboratories.

No matter how many complaints have been registered [5] regarding misdiagnosis due to false negative serology over the past three decades, nothing changes. Dr. Durand and I were at this ten years ago.

The unimaginable pain and suffering are detailed in the patient testimony of Aug 23rd. [6] Thank you Rep Cushman for uploading that video to Rumble for the record.

I don’t possess the legal knowledge to determine if a crime has been committed here even though it certainly appears to be the case.

In closing I have two action items:

1.  I would like to ask the Chair to assist with approaching the Attorney General with a possible inquiry detailing the specifics of the alleged crime.

2.  Propose legislation following Virginia’s bill requiring a disclaimer to be added to every Lyme disease laboratory report. (See Attachment) [7]

I have one final question for the Chair; After presiding over this Commission how confident are you that if you or a family member is bitten by a tick that transmits Lyme disease, you’ll receive an accurate and timely diagnosis?

Carl Tuttle
Hudson, NH

Correction: The Rahn & Malawista statement; “In some patients, the IgM antibody level remains elevated for many months or IgM antibody reappears late in illness; these phenomena predict continued infection.” was published March 15, 1991 in the Annals of Internal Medicine. [8]

Dearborn 1 was held on Nov 1-2 1990

Case Definition from the transcript:

https://www.dropbox.com/s/0qlvxkf72gu1dhl/Dearborn%201%20Case%20Definition.jpg?dl=0

https://www.dropbox.com/s/mzi70r8fycc9lsv/Dearborn%201%20Case%20Definition%202.jpg?dl=0

Cautionary statement: (Lyme is a clinical diagnosis)

https://www.dropbox.com/s/4q9lrpv5gp4zw6u/Dearborn%201%20Serology%20Caution.jpg?dl=0

References

  1. Horowitz, R.I.; Freeman, P.R. Precision Medicine: retrospective chart review and data analysis of 200 patients on dapsone combination therapy for chronic Lyme disease/posttreatment Lyme disease syndrome: part 1. International Journal of General Medicine  https://pdfs.semanticscholar.org/5085/03c18ba7e0f39a0922dd9af7e05f272f2419.pdf
  2. Characteristics of seroconversion and implications for diagnosis of post-treatment Lyme disease syndrome: acute and convalescent serology among a prospective cohort of early Lyme disease patients  https://link.springer.com/article/10.1007%2Fs10067-014-2706-z
  3. TruthCures Brochure  https://www.dropbox.com/s/a1x6lwsktkp3x5w/NH%20Handout.pdf?dl=0
  4. June 1994 FDA Meeting with Dattwyler Comment  https://www.dropbox.com/s/sxozktu3117enj9/June%201994%20FDA%20Meeting%20with%20Dattwyler%20Comment.pdf?dl=0
  5. 2010 Letter Jose T. Montero, MD, Director NH Dept. of Health  https://www.dropbox.com/s/3pfjav6mtj50hkd/2010%20Letter%20Jose%20T.%20Montero%2C%20MD%2C%20Director.pdf?dl=0
  6. Video recording of testimony from the Aug 23rd meeting  https://rumble.com/vmyzi9-nh-commission-to-study-testing-for-lyme-and-other-tick-borne-diseases-08.23.html
  7. § 32.1-137.06. Lyme disease test result information State of Virginia  https://law.lis.virginia.gov/vacode/title32.1/chapter5/section32.1-137.06/
  8. Lyme Disease: Recommendations for Diagnosis and Treatment  Daniel W. Rahn, MD, Stephen E. Malawista, MD  https://www.acpjournals.org/doi/abs/10.7326/0003-4819-114-6-472

Burrascano Webinar on Borreliosis Testing (Lyme & TBRF)

https://www.lymedisease.org/burrascano-webinar-borreliosis/

Burrascano webinar on borreliosis testing (Lyme and TBRF)

The name “borreliosis” can refer to two distinct but similar infections: Lyme disease and tick-borne relapsing fever (TBRF).

Both diseases result from different subspecies of Borrelia. They exhibit many of the same symptoms and both are spreading geographically.

According to world-renowned Lyme disease specialist Dr. Joseph Burrascano, these diseases present significant challenges to patients and healthcare practitioners alike.

Dr. Burrascano recently presented a webinar with IGeneX, Inc., about testing for both infections. Dr. Jyotsna Shah, president and laboratory director of IGeneX, joined him in the question and answer period.

Better Diagnostic Teesting: Antibodies & Beyond

https://www.lookingatlyme.ca/2021/10/40-better-diagnostic-testing-antibodies-and-beyond-with-dr-armin-schwarzbach/  Webinar Here

40. Better diagnostic testing: antibodies and beyond with Dr. Armin Schwarzbach

Detecting Lyme disease and related infections.

Episode 40 with Dr. Armin Scharwzbach from Armin Labs in Augsburg Germany.

In this episode of Looking at Lyme, we go to Augsburg, Germany to learn about diagnostic testing with Dr. Armin Schwarzbach, MD, PhD.

Dr. Schwarzbach is a specialist in laboratory medicine and infectious diseases, having worked in the field for over 20 years. He recalls one of his patients who was diagnosed with Multiple Sclerosis and tested positive for a test that was then called a lymphocyte transformation test for Borrelia burgdorferi even though she subsequently tested negative for antibodies to the bacteria. The patient had not responded to previous treatment for her MS (with steroids) but recovered after being treated for Lyme disease.

“[The Western Blot] is a screening test for transmission of Borrelia burgdorferi but not an activity test…I never have seen such cases where there are no antibodies, but cellular immune reactions.”

Dr. Armin Schwarzbach

Testing options

After recognizing that routine antibody tests for Lyme disease were unreliable, Dr. Schwarzbach decided to explore other methods of cellular analytics for patients with tick-borne illnesses based on cellular immune reactions. Although these tests are now performed in some other labs in Germany, Dr. Schwarzbach points out that many countries, including Canada, are not currently offering these types of tests. Canadian patients currently have to arrange to have their blood samples shipped to Germany to access the tests done at his laboratory.

“When I travelled around and people contacted me [I found that] nobody is doing the test in Canada, (or in many other countries).”

Dr. Armin Schwarzbach

B cells and T cells

Dr. Schwarzbach describes the difference between direct and indirect testing. Direct testing, including cultures and PCR (polymerase chain reaction) tests, look for direct evidence of a pathogen. Indirect testing, including antibody and t-cell tests, look at the body’s immune response to a pathogen. He differentiates between B cells, or antibodies in the form of proteins, and T-cells which are living cells called lymphocytes. Dr. Schwarzbach points out that in the US, the Centre for Disease Control (CDC) actually prefers a T-cell test for tuberculosis, but does not yet accept this test for Lyme disease.

 “B cells are the antibodies and the T cells are the lymphocytes. Antibodies are proteins, lymphocytes are living cells…in the whole diagnostic world I think (T cells) are underrepresented.”

Dr. Armin Schwarzbach

Antibody anomalies with Lyme disease

Dr. Schwarzbach also explains one of the other anomalies seen in Lyme disease patients. With other infections, IgM antibodies are normally produced early in the infectious process and IgG antibodies in the long term. In Lyme disease, they are observing the persistence of IgM antibodies but not IgG antibodies. He collaborated with professor Dr. Leona Gilbert, who was leading research on multiple tick borne diseases as well as persister forms and intracellular forms of Borrelia burgdorferi, sometimes called round bodies, cysts, or L-forms. Dr. Leona Gilbert discussed her research with Sarah in Season One of Looking at Lyme.

Testing for multiple infections

This research led to the creation of a test panel called the TickPlex, which includes various co-infections and opportunistic infections. Dr. Schwarzbach notes that a patient can test positive for multiple infections even if they test negative for Lyme disease. He explains that co-infections (also called tick-borne or vector-borne infections) are caused by pathogens found in vectors such as ticks, whereas opportunistic infections are already in our bodies and are normally kept under control by our immune system. When our immune system is not functioning properly, these opportunistic infections can re-activate, creating further health issues for patients with tick-borne infections such as Lyme disease.

“The TickPlex was developed because…we saw together with professor Gilbert that there are persister forms…we said why should we not test for these persister form antibodies…and that was a breakthrough because we found around 98% now with a persister form of antibodies.”

Dr. Armin Schwarzbach

The three “I’s” of infection

Dr. Schwarzbach explains that one of the biggest roadblocks to better testing is that many authorities don’t accept the concept of chronic infection. He hopes this will improve with the increased use of other testing modalities such as the TickPlex test. He discusses diagnostics for infections using the three “I’s”;  IgA, IgG and IgM antibodies, immune dysfunction tests, and inflammatory markers. Another test for Borrelia burgdorferi and SARS-CoV-2 is the I-spot, which can test both for past and current infection, and biopsy or tissue testing.  Dr. Schwarzbach points out that all of these tests are helpful not only for initial diagnosis, but also for monitoring patient progress and treatment effectiveness. He also notes that test results need to be considered in conjunction with what is happening clinically with patients, and with what patients are experiencing.

“What I see in this model with the three ‘I’s’ with SARS CoV-2, we diagnose it with antibodies, IgG, IgA…the second ‘I’ is the immune dysfunction…and the (third) ‘I’…is inflammation, the inflammatory markers…(we can) help therapists and to give additional information about infection, inflammation and immune dysfunction.”

Dr. Armin Schwarzbach

The COVID connection

What do Lyme disease, COVID and HIV infections have in common? They all can all cause reactivation of dormant infections in our bodies such as Epstein-Barr, Herpes Simplex, Coxsackie and Cytomegaloviruses as well as imbalances in yeast, mold and gut bacteria. In fact, in a recent study, 66.7% of long COVID patients were found to have reactivation of Epstein-Barr Virus. Dr. Schwarzbach points out that these patients may have other opportunistic infections which require diagnostic testing. He even developed a checklist to help clinicians determine which opportunistic infections may be active in their patients.

“I accept chronic infections… but the majority of doctors don’t accept this. They say yes you can have a current or recent infection… but it cannot get chronic. This is the struggle we have politically… I’m fighting for the acceptance of chronic infection, and this we can do by these wonderful blood tests.”

Dr. Armin Schwarzbach

New directions in testing

Looking to the future, Dr. Schwarzbach hopes to develop tests for biofilms, parasitic infections, gut viruses and bacteria, as well as yeast and mold. Thank you Dr. Schwarzbach for filling us in on the latest testing for infections that can be associated with Lyme disease! Remember to keep an eye out for ticks even as the weather gets cooler, and stay safe in the outdoors!

Resources

“(With the TickPlex test) we found also that all of these patients had multiple infections, so called co-infections from tick bites or re-activated infections, we name opportunistic infections; viruses and so on…so (Dr. Gilbert) designed a panel for that.”

For more: