Archive for the ‘research’ Category

Borrelia burgdoeri Co-Localizing With Amyloid Markers in Alzheimer’s Disease Brain Tissues

https://content.iospress.com/articles/journal-of-alzheimers-disease/jad215398

Borrelia burgdorferi Co-Localizing with Amyloid Markers in Alzheimer’s Disease Brain Tissues

Accepted Oct. 24, 2021, Published Dec. 5, 2021

Authors: Senejani, Alireza G.a; * | Maghsoudlou, Jasmina | El-Zohiry, Dinaa | Gaur, Gauria | Wawrzeniak, Keitha | Caravaglia, Cristinaa | Khatri, Vishwa A.a | MacDonald, Alanb | Sapi, Evaa

Affiliations: [a] Department of Biology and Environmental Sciences, University of New Haven, West Haven, CT, USA | [b] Molecular Interrogation Research Laboratory, Naples, FL, USA

Correspondence: [*] Correspondence to: Alireza G. Senejani, Department of Biology and Environmental Sciences, University of New Haven, 300 Boston Post Road, West Haven, CT, 06516, USA. E-mail: asenejani@newhaven.edu.

Abstract:

Background:

Infections by bacterial or viral agents have been hypothesized to influence the etiology of neurodegenerative diseases.

Objective:

This study examined the potential presence of Borrelia burgdorferi spirochete, the causative agent of Lyme disease, in brain autopsy tissue of patients diagnosed with either Alzheimer’s (AD) or Parkinson’s diseases.

Methods:

Brain tissue sections from patients with age-matched controls were evaluated for antigen and DNA presence of B. burgdorferi using various methods. Positive Borrelia structures were evaluated for co-localization with biofilm and AD markers such as amyloid and phospho-tau (p-Tau) using immunohistochemical methods.

Results:

The results showed the presence of B. burgdorferi antigen and DNA in patients with AD pathology and among those, one of them was previously diagnosed with Lyme disease. Interestingly, a significant number of Borrelia-positive aggregates with a known biofilm marker, alginate, were found along with the spirochetal structures. Our immunohistochemical data also showed that Borrelia-positive aggregates co-localized with amyloid and anti-phospho-tau markers. To further prove the potential relationship of B. burgdorferi and amyloids, we infected two mammalian cell lines with B. burgdorferi which resulted in a significant increase in the expression of amyloid-β and p-Tau proteins in both cells lines post-infection.

Conclusion:

These results indicate that B. burgdorferi can be found in AD brain tissues, not just in spirochete but a known antibiotics resistant biofilm form, and its co-localized amyloid markers. In summary, this study provides evidence for a likely association between B. burgdorferi infections and biofilm formation, AD pathology, and chronic neurodegenerative diseases.

For more:

My holistic doctor (RIP) was in his 90’s when he retired.  His proclivity for studying history was a marvel, and it would behoove us to do the same. A few interesting facts:

  • Syphilis was initially treated with mercury.
  • Later, they used malaria to induce a high fever (hyperthermia) which cured some patients.
  • Hyperthermia is used today in some Lyme clinics.
  • The development of penicillin in the 1940s sounded the death knell for syphilis.  Source

My old, retired doc reminded me that the mental wards were emptied out after they administered penicillin, as many of the patients had late-stage syphilis and all they needed was help killing the spirochetes in their brains. It makes complete logical sense that this approach – and studying other antimicrobials for effectiveness as well, would also work with many Lyme/MSIDS patients who have dementia and Alzheimer’s, but our corrupt public health ‘authorities’ are too busy trying to control our lives to be concerned with such trifles.

Please note that two of the researchers that did the study have been attempting to bring the spirochetal-brain connection for decades.  We owe Dr. McDonald and Dr. Sapi a debt of gratitude we will never be able to repay,

Category:

Alzheimer's, Biofilm, Lyme, Psychological Aspects, research

LDA-Columbia 2021 Lyme Conference Videos Available for Public Viewing

The Lyme Disease Association Inc. (LDA) has been able to release for the public on LDA’s You Tube Channel, a number of lectures from the LDA-Columbia 21st annual Lyme & Tick-borne Diseases 2021 CME conference.  See lectures by

  • John Aucott
  • Adrian Baranchuk
  • Ed Breitschwerdt
  • Catherine Brissette
  • Marna Ericson
  • Brian Fallon
  • Kim Lewis
  • Ken Liegner
  • Ricardo Maggi

Topics include Lyme & COVID 19; cardiac manifestations of Lyme; Bartonella; Borrelia colonizing dura matter; Suicidal behavior & Lyme; Lyme therapies; Disulfiram treatment for Lyme; PCR detection of Borrelia, Babesia & Bartonella; and Bartonella henselae in malignant melanoma.

NOTE: Some videos are not available due to ongoing research on the topic.

https://www.youtube.com/watch?v=NZV1HL1nwxk&list=PLxRaIwc57w2kisRXk9-UNBirXjc1xx6iY  Go Here for presentations

Category:

Bartonella, Lyme, research

A Test to Find Many Infections at Once On Horizon

https://www.lymedisease.org/multiplex-test-on-horizon/

LYME SCI: A test to find many infections at once is on the horizon

Dec. 13, 2021

By Lonnie Marcum

What if you had access to a single test that could detect 3 different kinds of vector-borne bacteria all at the same time?  Well, it looks like researchers out of North Carolina State University and Galaxy Labs have done just that.

Research led by Ricardo Maggi, Ed Breitschwerdt, and colleagues has led to the development of a new test utilizing a multiplex droplet digital PCR “BBB ddPCR” that can simultaneously detect the three B’s—Babesia, Bartonella and Borrelia from both the Lyme and relapsing fever complex. (Maggi et al., 2021)

Once this combined test is clinically validated and available for clinical use, it will lead to improved diagnostics for patients with Lyme and other vector-borne diseases.

Humans and animals are greatly affected by tick-borne diseases. Currently, 75% of all vector-borne disease cases reported in the U.S. are caused by ticks. And 82% of the tick-borne cases are due to Lyme disease. (Rosenberg et al., 2018)

“Standard” tests fall short

Despite recent advancements for diagnostic testing for other illnesses, the CDC continues to recommend tests for Lyme and other tick-borne diseases that were designed more than three decades ago—and fall way short of what’s needed.

For example, the CDC-endorsed two-tier test for Lyme disease predates a full understanding of the immune response to Lyme disease. It has several technical limitations, including the inability to differentiate between active infection, past infection, and reinfection. (Branda et al., 2018; Schutzer et al., 2019)

The standard test combination also misses 89% of early infection (false-negatives), cannot detect all strains of disease-causing Borrelia, and suffers from cross-reactivity with other infectious diseases leading to false-positives. (Steere et al., 2008; Cook, Puri, 2016)

“The ability to co-amplify multiple vector-borne pathogens within a single sample with high sensitivity will greatly enhance the efficiency and efficacy of clinical diagnostic testing, particularly of volume-limited or otherwise hard to obtain sample matrices,” the authors state.

New approaches needed

New diagnostic approaches have been effectively applied to diseases such as Zika. And COVID-19, a disease discovered less than two years ago, already has better diagnostic tools available to it than tick-borne infections identified nearly a century ago.

Importantly, serology testing for COVID was deemed unreliable and unsuitable for diagnosis, yet serology remains the diagnostic standard of care for tick-borne diseases. (Serology tests look for antibodies in blood serum.)

All tick-borne diseases face major hurdles that prevent accurate early diagnosis and treatment. Serology as a diagnostic standard of care is problematic for all infections, but is especially problematic for immune-evasive, low-abundance infections.

Microbial testing techniques

Commonly used diagnostic techniques for tick-borne diseases include both direct and indirect detection methods, though some are only used in research studies. Both direct and indirect diagnostic methods are prone to false-negative and false-positive results.

For this reason, many experienced Lyme and tick-borne disease practitioners will recommend a combination of both direct and indirect tests, or a series of tests to confirm a diagnosis.

  • Direct detection methods directly confirm the presence of a pathogen. Direct methods for tick-borne diseases include: growing the pathogen in culture; microscopic examination of blood or tissue; polymerase chain reaction (PCR) which detects the DNA of one pathogen; quantitative PCR (qPCR) detects the quantity of a pathogen; multiplex PCR detects DNA of more than one pathogen; and fluorescence in situ hybridization (FISH) “maps” the genetic material in cells.
  • Indirect detection  methods detect the host immune system’s response to infection, providing indirect evidence of infection. Indirect  methods are able to determine if there has been recent or prior exposure to a pathogen. These methods, however, cannot confirm if an infection is active, nor whether it has been cleared. The most frequently used indirect serologic tests for tick-borne diseases include ELISA (enzyme-linked immunosorbent assay); IFA (immunofluorenscence antibody test); immunoblots like the Western blot; enzyme-linked immunospot (ELISPOT); and lymphocyte transformation tests (LTTs). (Springer et al., 2021)

Looking for antibodies

Both direct and indirect detection techniques have their strengths and weaknesses. For example, the most common tests for Lyme disease, the ELISA and Western blot, both  look for antibodies generated as the immune system tries to fight the infection.

Immunocompromised patients who do not mount a proper immune response, or those who receive early treatment may not develop detectable antibodies.

In addition, intracellular, low-yield and stealth pathogens like Borrelia and Bartonella are notoriously difficult to find by direct detection techniques like PCR.

The main reason for this is that little DNA from “low abundance” pathogens is found in blood. If there’s not enough DNA in the blood sample, standard PCR  cannot detect it.

Because of this, blood has not been the preferred sample type for detecting Borrelia burgdorferi DNA by PCR. However, PCR has had more success detecting the relapsing fever species of Borrelia, due to the higher levels of spirochetes in the blood. Conventional PCR, however, can be useful for the detection of Borrelia DNA from skin biopsies of Lyme-associated rashes, the fluid or tissue from joints (synovial fluid and synovium.)

The new approach

The research team, led by Dr. Ricardo Maggi and Dr. Ed Breitschwerdt at NCSU and Dr. Jennifer Miller at Galaxy Diagnostics, based their new multiplex droplet digital PCR assay “BBB ddPCR” on a wealth of knowledge they’ve gained from developing better diagnostics for Bartonella.

They recently published a paper explaining how their “BAPGM enrichment” along with the ddPCR improves upon the standard qPCR for Bartonella. (Maggi et al., 2020)

The proprietary BAPGM™ liquid culture increases the number of bacteria in a blood sample, allowing easier detection by PCR. With the “ddPCR, instead of running one PCR on one sample, the extracted DNA gets generated into 10,000-20,000 droplets. We then run a PCR reaction on each droplet,” explains Amanda Elam, PhD. “Bartonella ddPCR alone is incredible, increasing sensitivity about 10 times over standard PCR.”

The new assay, called the “multiplex BBB ddPCR,” detected DNA from 24 species of Babesia, 31 Bartonella species, and 13 Borrelia species (from the Lyme disease, relapsing fever, and cluster of Borrelia associated with reptiles).

The assay also detected two Theileria species (T. equi and T. cervi), as well as Chlamydophila felis DNA from naturally infected animals.

The authors state, “The multiplex BBB ddPCR assay presented herein reliably detected single and co-infections involving vector-borne pathogens from the genera Babesia, Bartonella, Borrelia, and Theilaria, using a variety of animal and human clinical samples, vectors, and experimentally infected tissues and cell-lines.”

Bringing new tests to market takes time

As Amanda Elam, Phd, CEO & Co-founder of Galaxy Labs, explained during this year’s Invisible International conference, the development process for commercializing a new test, from prototype to clinical validation to FDA approval, can take 5-10 years.

Elam says it may be another two years before the multiplex BBB ddPCR test is available to the public. She anticipates the individual ddPCR tests for Bartonella, Babesia and Borrelia will be available sooner.

The researchers state they have future plans to add other vector-borne organisms such as Anaplasma, Ehrlichia, and Rickettsia species to the existing multiplex ddPCR platform. In my opinion, a single assay able to detect multiple species of the most common tick-borne diseases would have profound effects on both animal and human medicine.

Early diagnosis is critical

Patients who receive early diagnosis and prompt treatment for tick-borne diseases tend to get better. But what about the huge percentage of patients who are not diagnosed quickly? In fact, fewer than 12% of the 14,000+ patients in LymeDisease.org’s patient-led research project, MyLymeData, received a diagnosis within the first month after the tick bite. (Johnson, 2019)

A delayed diagnosis is critical to understanding why so many patients are left with debilitating symptoms after standard treatment for Lyme. (Fallon et al., 2008; Fallon et al., 2012) During the months to years that patients suffer without a diagnosis, the untreated infection spreads throughout the body, embedding itself deeply into connective tissues where standard antibiotics have a hard time reaching. (Cabello et al., 2017; Caskey, Embers, 2015; Embers et al., 2012; Gadila et al., 2021)

One study demonstrated that delaying treatment by as little as 9-19 days is predictive of persistent Lyme symptoms. (Bouquet et al., 2016) During this time, infection can spread to the organs, brain, bone marrow, and heart. (Coughlin et al., 2018; Novak et al., 2019)

Early diagnosis of tick-borne diseases can save lives. Using advanced molecular detection techniques, these researchers have shown how an improved multiplex assay can more rapidly diagnose patients infected with multiple pathogens, speeding the delivery of life saving treatment.

Here’s what we need

We currently need better diagnostic tools for all tick-borne diseases including:

  • Anaplasmosis,
  • Babesiosis (Babesia duncani, Babesia microti),
  • Borrelia miyamotoi disease,
  • Bourbon virus disease,
  • Colorado tick fever,
  • Ehrlichiosis (E. chaffeensis, E. ewingii, E. muris),
  • Heartland virus disease,
  • Lyme disease (Borrelia burgdorferi, B. mayonii)
  • Powassan virus disease,
  • Rocky Mountain spotted fever,
  • Rickettsiosis (R. parkeri, R 364D),
  • S.T.A.R.I. (Southern Tick-Associated Rash Illness)
  • Tick-borne relapsing fever (B. hermsii, B. turicatae, B. parkerii)
  • Tularemia

I’ve written about several other types of advanced diagnostics on the horizon. I look forward to seeing promising tests like these become more widely available.

LymeSci is written by Lonnie Marcum, a Licensed Physical Therapist and mother of a daughter with Lyme. She serves on a subcommittee of the federal Tick-Borne Disease Working Group. Follow her on Twitter: @LonnieRhea  Email her at: lmarcum@lymedisease.org.

References

Bouquet J, et al (2016) Longitudinal Transcriptome Analysis Reveals a Sustained Differential Gene Expression Signature in Patients Treated for Acute Lyme Disease. Am Society Micro. DOI: 10.1128/mBio.00100-16

Branda JA., et al. (2018) Advances in Serodiagnostic Testing for Lyme Disease Are at Hand, Clinical Infectious Diseases, Volume 66, Issue 7, 1 April 2018, Pages 1133–1139, https://doi.org/10.1093/cid/cix943

Cabello FC, Godfrey HP, Bugrysheva JV, Newman SA. (2017) Sleeper cells: the stringent response and persistence in the Borreliella (Borrelia) burgdorferi enzootic cycle. Environ Microbiol 19(10):3846-3862, 2017. doi: 10.1111/1462-2920.13897

Caskey JR, Embers ME. (2015) Persister Development by Borrelia burgdorferi populations in vitro. Antimicrob Agents Chemother 59(10):6288-6295, 2015. DOI: 10.1128/AAC.00883-15

Cook, MJ., Puri BK. (2016) Commercial test kits for detection of Lyme borreliosis: a meta-analysis of test accuracy. Int’l J of Gen Med. DOI https://doi.org/10.2147/IJGM.S122313

Coughlin, J.M., Yang, T., Rebman, A.W. et al. (2018) Imaging glial activation in patients with post-treatment Lyme disease symptoms: a pilot study using [11C]DPA-713 PET. J Neuroinflammation 15, 346. https://doi.org/10.1186/s12974-018-1381-4

Embers ME, Barthold SW, Borda JT, Bowers L, Doyle L, Hodzic E, Jacobs MB, Hasenkampf NR, Martin DS, Narasimhan S, Phillippi-Falkenstein KM, Purcell JE, Ratterree MS, Philipp MT. (2012) Persistence of Borrelia burgdorferi in rhesus macaques following antibiotic treatment of disseminated infection. PLoS One 7(1):e29914, 2012. https://doi.org/10.1371/journal.pone.0029914

Fallon BA, Keilp JG, Corbera KM, Petkova E, Britton CB, Dwyer E, Slavov I, Cheng J, Dobkin J, Nelson DR, Sackeim HA. (2008) A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. Neurology. 70(13):992-1003. doi: 10.1212/01.WNL.0000284604.61160.2d. Epub 2007 Oct 10. PMID: 17928580.

Fallon, Brian & Petkova, Eva & Keilp, John & Britton, Carolyn. (2012). A Reappraisal of the U.S. Clinical Trials of Post-Treatment Lyme Disease Syndrome. The open neurology journal. 6. 79-87. 10.2174/1874205X01206010079.

Gadila SKG, Rosoklija G, Dwork AJ, Fallon BA and Embers ME (2021) Detecting Borrelia Spirochetes: A Case Study With Validation Among Autopsy Specimens. Front. Neurol. 12:628045. doi: 10.3389/fneur.2021.628045

Johnson, Lorraine (2019): 2019 Chart Book — MyLymeData Registry. (Phase 1 April 27, 2017. Sample 3,903). figshare. Preprint. https://doi.org/10.6084/m9.figshare.7849244

Maggi R, Breitschwerdt EB, Qurollo B, Miller JC. Development of a Multiplex Droplet Digital PCR Assay for the Detection of Babesia, Bartonella, and Borrelia Species. Pathogens. 2021; 10(11):1462. https://doi.org/10.3390/pathogens10111462

Maggi RG, Richardson T, Breitschwerdt EB, Miller JC. Development and validation of a droplet digital PCR assay for the detection and quantification of Bartonella species within human clinical samples. J Microbiol Methods. 2020 Sep;176:106022. doi: 10.1016/j.mimet.2020.106022. Epub 2020 Aug 11. PMID: 32795640.

Novak P, Felsenstein D, Mao C, Octavien NR, Zubcevik N (2019) Association of small fiber neuropathy and post treatment Lyme disease syndrome. PLoS ONE 14(2): e0212222. https://doi.org/10.1371/journal.pone.0212222

Rosenberg R, Lindsey NP, Fischer M, et al. (2018) Vital Signs: Trends in Reported Vectorborne Disease Cases — United States and Territories, 2004–2016. MMWR Morb Mortal Wkly Rep 2018;67:496–501. DOI: http://dx.doi.org/10.15585/mmwr.mm6717e1

Schutzer, S.E., et al. (2019) Direct Diagnostic Tests for Lyme Disease, Clinical Infectious Diseases. 3/15, 68 (6), 1052–1057. doi: https://doi.org/10.1093/cid/ciy614

Springer, A., Glass, A., Probst, J. et al. Tick-borne zoonoses and commonly used diagnostic methods in human and veterinary medicine. Parasitol Res 120, 4075–4090 (2021). DOI: https://doi.org/10.1007/s00436-020-07033-3

Steere, A. C., McHugh, G., Damle, N., & Sikand, V. K. (2008). Prospective study of serologic tests for lyme disease. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 47(2), 188–195. https://doi.org/10.1086/589242

Category:

Babesia, Bartonella, Lyme, research, Testing

Lyme Arthritis in Children Can Present Throughout the Year

https://danielcameronmd.com/lyme-arthritis-in-children-can-present-throughout-the-year/

Lyme arthritis in children can present throughout the year

Lyme arthritis in children

Lyme arthritis in children can present throughout the year for those living in areas endemic for Lyme disease, according to a study by Sundheim and colleagues. In their article, “Seasonality of Acute Lyme Disease in Children,” investigators described 690 children with Lyme disease residing in three endemic regions of the United States. [1]

By

The study’s objective was to “evaluate the seasonality of pediatric Lyme disease in three endemic regions in the United States,” writes Sundheim. Participants had been treated at 8 different medical centers throughout the Northeast and UpperMidwest.

Of the 690 children with Lyme disease, 77 (11.2%) had a single EM lesion, 247 (35.7%) had early disseminated disease, and 366 (53.1%) had arthritis, wrote the authors. “Children with early and early-disseminated Lyme disease most frequently presented in the summer months (June through August).”

The authors acknowledged that results could not be applied to non-endemic areas of the country, as all the participating centers were located in regions endemic for Lyme disease.

The authors did not routinely test for co-infections. “Multiplex polymerase chain reaction panels for tick-borne co-infections have demonstrated that a substantial portion of adults with Lyme disease have co-infections.”

Editor’s comments: Sundheim et al. dismissed 2,490 children (78.3%) as clinical mimics. It would have been helpful if the authors had followed up these children to determine whether any of them might have presented with Lyme disease over time.

The authors did not appear to look for other manifestations of Lyme disease and focused rather on individuals with “early (single EM lesion), early-disseminated (multiple EM lesions, headache, cranial neuropathy, or carditis), or late (arthritis).”

References:
  1. Sundheim KM, Levas MN, Balamuth F, et al. Seasonality of Acute Lyme Disease in Children. Trop Med Infect Dis. Nov 9 2021;6(4)doi:10.3390/tropicalmed6040196

Category:

Lyme, research

FDA’s Suspicious Timing on ‘Wanting More Information’ on NAC – Which Helps COVID & Lyme/MSIDS

https://articles.mercola.com/sites/articles/archive/2021/12/15/fda-wants-more-information-on-nac

FDA Wants More Info on NAC

Analysis by Dr. Joseph Mercola Fact Checked

December 15, 2021

n acetylcysteine

Story at-a-glance

  • The Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have filed separate citizen petitions with the FDA requesting that the agency reverse their position on NAC; the agency is now asking for more information on the 58-year-old supplement
  • According to some legal experts, the actions taken by the FDA are not legal under U.S. code Title 21. The FDA has used the exclusion provision three other times, all of which financially benefited the pharmaceutical industry
  • While past actions may have opened the door to the most recent attack against NAC, it is not difficult to understand why the FDA chooses now to target NAC, when it has demonstrated effective action against COVID-19
  • Evidence suggests those with a glutathione deficiency have worse outcomes with COVID-19. NAC is a precursor to glutathione and may help lower the risk of severe disease
  • NAC can be part of your early at-home treatment that is crucial to lowering the severity of the illness and reducing the risk of long-haul symptoms

N-acetylcysteine (NAC) is a powerful antioxidant that was approved as a drug in September 1963.1 Since that time it’s been used as a nutritional supplement that is not found in natural sources.2 NAC contains the amino acid cysteine, which is a precursor to glutathione, also called “the master antioxidant.”3

Glutathione is made of three amino acids — glutamic acid, glycine and cysteine.4 However, NAC is only available in supplement form. The precursors to NAC can be found in foods that are high in cysteine, which include pork, beef, chicken, eggs, dates and sunflower seeds.5

NAC is used in prescription form as an antidote for acetaminophen-induced hepatotoxicity.6 It is also a powerful mucolytic agent for use in upper respiratory conditions. Memorial Sloan-Kettering7 also lists uses in the treatment of depression, precancers, HIV and AIDS, and to alleviate cancer treatment side effects.

In 2020, NAC made the news when the FDA decided over-the-counter sales of this compound, which at that time had been available for 57 years, should require a physician’s prescription going forward. The FDA issued warning letters8 to seven companies the agency said were illegally selling hangover products. By May 2021, Amazon, which also owns Whole Foods, decided to remove any supplements containing NAC.9

FDA Requests More Information on NAC

As Natural Products Insider reports, the letters warned that NAC could not be “lawfully marketed in dietary supplements because it was first studied as a drug in 1963.”10 The Council for Responsible Nutrition (CRN) sent a letter in December 2020 to the FDA’s Office of Dietary Supplement Programs describing the position as “legally invalid.”11

The CRN and the Natural Products Association (NPA) filed separate citizen petitions with the FDA. The CRN letter in December 2020 challenged the FDA’s determination that NAC should be precluded from supplementary use.12 They then filed a citizen position petition June 1, 2021, requesting the FDA reverse their position and outlining why this sudden policy change is “legally invalid on multiple grounds.”13

The NPA filed a separate citizen petition with the FDA14 requesting that the agency not exclude NAC as a dietary supplement or, alternatively, that the Department of Health and Human Services (HHS) issue a regulation finding NAC is lawful in supplements. While the HHS has the authority, it has not been used in the 27 years since the law giving the HHS such power was enacted in 1994.

November 24, 2021, the FDA announced they were requesting more information about how NAC has been marketed as a dietary supplement.15 Natural Products Insider reports that this was encouraging to some in the industry as it signaled the FDA was open to the idea of issuing the regulation that NAC is a lawful ingredient in supplements.16 The FDA called this:17

“… tentative responses to both citizen petitions, requesting additional information from the petitioners … and noting that the agency needs additional time to carefully and thoroughly review the complex questions posed in these petitions.”

The FDA18 also requested information and data on the date that NAC was first marketed as a dietary supplement, reports of adverse events and details on how the products are marketed and sold. The data are requested by January 25, 2022. Steve Mister, president and CEO of CRN said in a statement:19

“The provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA) may not be interpreted retroactively to remove ingredients that were lawfully marketed in 1994 and have enjoyed a long history of safe use since then. The delay in clearing up the status of NAC by asking for more data and refusing to admit its error disregards the law and disserves consumers who use NAC.

This is not a complicated determination for the FDA to make. DSHEA makes clear that ingredients in use as dietary supplement ingredients prior to its enactment are grandfathered into the supplement marketplace. Thus, pharmaceutical manufacturers could not have had any expectation of exclusivity in the years prior to the creation of this provision of the law.

Given the long history of safe use of NAC, FDA cannot now try to establish a safety concern in order to award this ingredient exclusively to drug makers.”

FDA First Used Legally Questionable Drug Exclusion Provision

U.S. code Title 21,20 specifically defines what a dietary supplement is and is not. According to experts, the actions of the FDA in banning the sale of NAC and finding it a “medication” is illegal under the law. Attorney Stan Soper21 writes that under Title 21 §321 paragraph (ff)(3)(b)10 the actions of the FDA do not meet the Drug Exclusion Provision.

According to Soper,22 the exclusion provision has only been invoked a few times, specifically when used to keep red yeast rice, vitamin B6 and cannabidiol (CBD) from being sold as supplements. In each of these cases there was a potential pharmaceutical financial loss that triggered the assertion the supplement was illegal.

In the case of red yeast rice, it contains a naturally occurring substance that acts in a similar manner to Lovastatin, a statin medication.23 In 2005, drug manufacturer Biostratum filed an investigational new drug (IND) application with the FDA to use vitamin B6 in the treatment of diabetic kidney disease.

Their argument was there was “no evidence that it was marketed as a dietary supplement or food prior to its IND and Phase II investigations.”24 In 2009 the FDA declared vitamin B6 was not a dietary supplement despite documentation that it had been sold as such before the IND application.

The FDA has also invoked the Drug Exclusion Provision against CBD, warning that it is not a legal dietary supplement since there was no meaningful evidence it was marketed as such before drug investigations were approved for Sativex and Epidiolex, which are drugs that contain CBD.

After the 2018 Farm Bill was signed legalizing hemp, then-FDA secretary Dr. Scott Gottlieb made the statement that it was illegal to introduce CBD into the food supply or market it as a supplement.25 Soper postulates26 that the use of the Drug Exclusion Provision against CBD may have opened the door for the FDA to use it against NAC.

Why Take Aim at NAC?

In the citizen petition27 sent to the FDA June 1, 2021, CRN argued that the FDA failed to sufficiently explain this sudden change in policy on NAC, thus “rendering it arbitrary and capricious.” According to CRN, before the seven warning letters in July 2020, “it was FDA’s longstanding policy to permit the marketing of dietary supplements containing NAC.”

Even though the agency had reviewed more than 100 notification structure/function claims for NAC-containing supplements over the years, they never raised the drug exclusion clause. In one response to a petition for a qualified health claim, the FDA had even stated that NAC was considered a dietary supplement.

While the Drug Exclusion Provision on CBD may have opened the door, it still raises the question of why the FDA chose now to target NAC. Historically the provision was used inappropriately to protect the finances of pharmaceutical companies. That is also likely the root of the motivation to ban NAC as a supplement.

As pulmonologist Dr. Roger Seheult succinctly explains in the MedCram video below, NAC is a crucial chemical compound necessary to reduce the oxidative stress associated with severe COVID-19 infections and thus may significantly impact the sales of antiviral drugs. And, as I and other health experts have pointed out in the past, without severe disease, is there truly a need for a vaccine?

Glutathione Depletion Worsens COVID-19 Outcomes

Researchers have been studying NAC since it was discovered. In 2010,28 researchers found that it could inhibit the expression of proinflammatory cytokines in cells that were infected with highly pathogenic H5N1 influenza virus. These same proinflammatory cytokines play a crucial role in severe COVID-19.

Researchers have confirmed that in severe cases, cytokine levels are elevated and once they reach excessive levels it triggers a cytokine storm.29 This causes significant tissue damage that NAC may be able to inhibit. In one 2020 paper,30 the authors describe a case of COVID-19 in a patient with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

This is a genetic disorder that can lead to hemolytic anemia31 and depletes glutathione,32 increasing the risk for human coronavirus infections such as the common cold. NAC was given to the G6PD-deficient patient and nine other COVID patients on ventilators. The NAC “elicited clinical improvement and markedly reduced CRP in all patients.”33

Other published papers have since demonstrated there is a potential use of NAC in the treatment of COVID-19.34,35,36 One 2021 study37 compared consecutive patients hospitalized with moderate or severe COVID-19 pneumonia.

One group received only standard care and the other group received 600 mg of NAC twice daily for 14 days. There were 42 in the NAC group and 40 in the control group. Treatment with NAC led to lower rates of severe respiratory failure and significantly lower mortality rates.

Early at Home Treatment Is Crucial

NAC is only one in a line of treatment modalities that have proven to be successful but have been vilified by governmental agencies. Since the start of this pandemic, it seems global and national health authorities have done everything in their power to discourage and prevent people from accessing treatments, such as ivermectin38,39,40 and hydroxychloroquine,41,42,43,44 that compete with the COVID jab.

The actions around NAC appear to be yet another shameful attempt to prevent patients from helping themselves. By limiting access to nutritional supplements that have demonstrated the capability of reducing severity of the infection, agencies are essentially boosting the risk that infections progress into more serious cases.

Should you come down with symptoms of COVID-19, early treatment is crucial. Not only can it significantly reduce the length of time that you’re sick, but early treatment will also minimize your risk of long-hauler syndrome,45 which can include symptoms that last much longer than the original infection.46 This can include cough, body aches, difficulty sleeping, headaches and brain fog.

There is also scientific evidence that NAC can improve a variety of lung problems, including pneumonia and acute respiratory distress syndrome (ARDS), common characteristics of COVID-19. For example:

  • Research47 published in 2018 found NAC reduces oxidative and inflammatory damage in patients with community-acquired pneumonia.
  • Another 2018 study48 found NAC improves postoperative lung function in patients undergoing liver transplantation.
  • A 2017 meta-analysis49 found a significant reduction in ICU stays among ARDS patients treated with NAC.
  • NAC is also a well-known mucolytic used to help clear mucus out of the airways of cystic fibrosis patients.50 Some studies also suggest NAC can help reduce symptoms of COPD and prevent exacerbation of the condition.51
– Sources and References

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**UPDATE**

Dr. José Luis Sevillano proposes a preventive treatment for Panamanian colleagues who at a conference were very interested in treating patients with zinc, glutathione, and N-acetylcysteine (NAC).  These antioxidants have been found to help the body detoxify graphene, which experts have discovered in the PCR swabs, face masks, and the COVID injections.  

**Comment**

On a personal note: my husband, infected with Lyme/MSIDS since 2010 or so has struggled with bizarre blood issues including low ferritin, small and too many red blood cells, hypercoagulation, and anemia at one point requiring iron sucrose infusions.  We were both infected with Babesia as well, which is known blood to affect and change blood cells.

Eventually the iron came up and leveled, the hypercoagulation went away (after years of heparin) but the cell count has always been strange, and he has always struggled with fatigue since becoming infected, whereas I have not.  I suspect a glutathione issue and wonder if glutathione IV wouldn’t have helped his severe COVID case as well.  Where IV C, blood ozone, and 4 doses of only 12 mg of ivermectin completely turned me around, he continued to languish while on much higher doses and even HCQ in the mix, and had many symptoms I did not have (severe headaches, skin eruptions, and horrific cough without end).   While I take NAC daily, he does not (which is going to change today!).

NAC and Lyme/MSIDS

This article shows that glutathione metabolism is the most important target of B. burgdorferi infection and is essential for cytokine production, likely through glutathionylation.

This article discusses how Dr. Horowitz, a well-known Lyme literate doctor, published the first study of two COVID patients treated with three natural supplements, hydroxychloroquine, and an antibiotic. At 9 and 11 days into treatment, with both patients seeing gradual but incomplete improvement, a corner turned.  **Horowitz has now substituted ivermectin for HCQ**

The breakthrough came after he increased the dose of glutathione.  Within an hour, both patients were breathing better. “I definitely felt like the edge was taken off my symptoms,” said one of them, David Roth, 53. “I felt it fairly quickly.”

Although anecdotal,” Horowitz said, “I have heard from patients who were on NAC and glutathione when they were exposed to COVID-19, that they did not get sick or test positive for the virus, when others around them did.”  Source

Horowitz protocol for prevention

Top tier:
Glutathione, 250 to 500 mg twice a day
N-acetylcysteine (NAC), 600 mg twice a day
Second tier but makes above even better:
Alpha lipoic acid, 600 mg once to twice a day
Zinc, 40 to 50 mg a day
Icing on the cake:
Curcumin, 1000 mg twice a day
Sulforaphane glucosinolate (broccoli seed extract), 100 mg twice a day
3, 6 Beta glucan, 500 mg to 1000 mg once a day

To treat the infection, Horowitz uses the same supplements as in the prevention protocol but in higher doses. He further adds high-dose Vitamin C and ivermectin, which shows promise for COVID and would have to be prescribed by a physician. (Please read article in full as there are many great suggestions)

I have spoken with other COVID patients, some infected with tick-borne illness and some not, and ALL have responded a bit differently to ivermectin.  I now wonder if the IV C and blood ozone didn’t help me more than I first believed as those things were not used by the other patients.  While I still believe ivermectin to be effective, results will vary from person to person and sometimes it’s a combination of things that support your individual Achilles heel that work best. Once again, independent Lyme literate doctors are going to be a better choice (or independent functional medicine practitioners and the like who actually think for themselves) as mainstream medicine doesn’t have time and doesn’t care about these issues.  They treat everyone with an archaic “one size fits all” approach that hasn’t worked since the beginning of allopathic medicine.

This goes to show that cases will very considerably, just like with Lyme/MSIDS.

Category:

Activism, Inflammation, research, Supplements, Viruses