Archive for November, 2020

Understanding Borrelia: Symptoms, Testing & Treatment for the Primary Lyme Bacteria

https://rawlsmd.com/health-articles/understanding-borrelia-symptoms-testing-treatment-for-the-primary-lyme-bacteria

Understanding Borrelia: Symptoms, Testing & Treatment for the Primary Lyme Bacteria

Understanding Borrelia: Symptoms, Testing & Treatment for the Primary Lyme Bacteria

by Dr. Bill Rawls
Posted 11/25/2020

In 1975, a mysterious illness causing arthritis in children showed up in Lyme, Connecticut and adjacent communities in the United States. It might have flown under the radar if not for one significant detail: A cluster of people (39 children and 12 adults), all bitten by ticks, also suddenly became ill simultaneously. Incidentally, it was at a time when more and more people were moving out of cities and into the suburbs to build homes in the tick-filled wooded countryside.

The illness, characterized by arthritis and an unusual rash around the tick bite, was first thought to originate from a viral agent. The real offender wouldn’t enter the spotlight until 1981, when a researcher named Dr. Willy Burgdorfer noticed that the symptoms of this new illness had striking similarities to a tick-borne condition long recognized in Europe called erythema migrans (EM), named for the associated rash migrating from a tick bite. Dr. Burgdorfer and his colleagues isolated the microbial culprit, a corkscrew-like organism (called a spirochete), from the blood of the victims, and a new pathogen rose to the forefront.

The microbe was named Borrelia burgdorferi (after Dr. Burgdorfer), and the illness was aptly termed Lyme disease after its place of origin. Once people became aware of the new microbe and the illness it caused, cases started popping up all over New England and beyond. Lyme disease seemed to be the newest plague.

In actuality, however, for more than 100 years, physicians in both North America and Europe had long-recorded illness associated with a migrating rash surrounding tick bites. But because they lacked a Lyme disease vaccine and effective treatment options, and because the illness was debilitating but not life-threatening, tick-borne diseases never garnered much attention.

Unfortunately, not much has changed since then in the medical community. Though Lyme is the most common vector-borne disease in the U.S., it’s still difficult to define and difficult to treat. It’s rarely life-threatening, though. Thus, many doctors today turn a blind eye to it. At the heart of this dilemma is a fundamental lack of understanding of the true nature of Borrelia burgdorferi.

3d illustration of red colored lyme disease pathogens on red underground

What has changed, however, is public awareness. Many people not only know about Lyme disease, but there is more public interest in it than ever before. This is largely due to vigorous advocacy efforts of patients, organizations, and celebrities openly sharing their stories about navigating the illness.

Borrelia burgdorferi is a stealth microbe that insidiously makes people chronically miserable, often for a lifetime. People no longer accept that they have to live with a chronic debilitating illness — rightfully, they want solutions.

Here, we’ll take a closer look at this covert pathogen, the symptoms of Lyme disease, testing and diagnoses, and solutions for overcoming it and restoring your health.

Symptoms Associated with Borrelia

Lyme disease symptoms will differ from one person to another. Some people may hardly experience any symptoms, while others become severely ill or have persistent, debilitating symptoms.

Despite the politicized and controversial nature of Lyme, there is one thing nearly everyone can agree on: The earlier you catch the illness, the better the chances for a successful outcome. If it goes untreated due to such factors as misdiagnosis or delayed diagnosis, you could be in for an uphill battle to regain your health.

Acute (Early-Stage) Lyme Disease

Symptoms of Acute Lyme Disease

One of the most well-known of the early signs and symptoms of Lyme disease is the classic “bull’s-eye” rash (erythema migrans) that appears several days, or sometimes weeks, after getting a tick bite. For the bull’s-eye rash, redness extends outward from the tick bite with an outer, more prominent red ring.

bulls eye rash on mans arm

Although the bull’s-eye rash has long been considered definitive proof of Lyme disease and more accurate than laboratory blood tests, even the rash may not be absolute. Only half to a third of people with Lyme disease will get a classic-looking rash, and only 10% of reported bull’s-eye rashes are associated with the presence of borrelia in the blood.

Other acute Lyme disease symptoms include:

  • Fatigue or tiredness
  • Chills
  • Headache
  • Neck stiffness
  • Muscle aches
  • Low-grade fever
  • Cardiac symptoms such as chest pain, shortness of breath, and feeling faint, which can be indicative of Lyme carditis, a serious heart manifestation of the disease

Note: A high fever and swollen lymph nodes generally indicate a coinfection with another microbe is present as well.

Having a history of tick bites, along with the bull’s-eye rash and other Lyme disease symptoms, is the most reliable way to diagnose infection with borrelia. If it looks like a duck and walks like a duck, it probably is a duck. However, even this type of diagnosis is far from absolute.

Chronic (Late-Stage) Lyme Disease

Chronic Lyme disease is rarely fatal, but it can make you miserable for a lifetime. Typically, people with chronic Lyme disease look normal on the outside. Routine screening labs at the doctor’s office often come back as normal, which can be extremely frustrating for patients because they are often discounted as not being ill.

Inside, however, deep in tissues, a chronic war is going on between a hidden microbe (or microbes) and the person’s immune system. This results in a broad spectrum of seemingly unrelated symptoms.

Symptoms of Chronic Lyme Disease

When Lyme disease becomes late-stage, persistent, or chronic, a different set of symptoms may emerge from the initial onset of the infection. These symptoms can include:

  • Tooth pain
  • Chronic infection
  • Chronic fatigue
  • Chronic pain
  • Migrating arthritis or joint pain
  • Muscle pain
  • Chronic flu-like symptoms
  • Headache
  • Neck stiffness and creaking
  • Bell’s palsy (paralysis or weakness in the facial muscles of one side)
  • Brain fog or loss of cognitive function
  • Heightened sensitivity and agitation to noise and sound
  • Ringing in the ears
  • Sleep disorders or trouble sleeping
  • Visual changes or blurry vision
  • “Floaters” in vision and eye discomfort
  • Dizziness and instability
  • Muscle twitching
  • Paresthesias (burning or tingling in feet and hands)
  • Tremors (head and hands)
  • Chest pain
  • Irregular heart beats
  • Shortness of breath or difficulty catching breath
  • Unstable bladder
  • Gastrointestinal (GI) or digestive dysfunction

The severity of a person’s symptoms is highly dependent on the person’s genetic makeup and the strength of their immune system. In symptomatic chronic Lyme disease, the immune system and the microbes reach a standoff. If the balance is tipped more in favor of the immune system, symptoms are less. If the balance is tipped more in favor of the microbe, symptoms will be greater.

Disease progresses, not because the microbe is winning, but because the chronic tug-of-war between the immune system and microbes accelerates the aging process. Tissues break down faster, and the individual becomes more susceptible to other chronic diseases. People who have had chronic Lyme disease for a long time have more difficulty overcoming it because there is more accumulated damage that must be reversed.

Coinfections with other microbes like bartonella, babesia, mycoplasma, and different strains of borrelia can also complicate the picture of chronic Lyme disease.

Diagnosing Borrelia

Developing tests to detect and diagnose Borrelia burgdorferi is a real challenge for a number of reasons that have to do with the qualities of the bacteria itself. Borrelia burgdorferi:

  • Hides deep in tissues, making the stealth pathogen difficult to diagnose
  • Can live inside cells (intracellular)
  • Has elaborate ways of tricking the immune system
  • Changes its genetic signature readily
  • Doesn’t require high concentrations of microbes to cause illness

In the United States, mainstream Lyme testing is specific for Borrelia burgdorferi, but there are approximately 21 other species of borrelia that fall within the category of Lyme disease, as reported in the journal Healthcare (Basel). In Europe, two different species of borrelia — Borrelia afzelii and Borrelia garinii — are more common than Borrelia burgdorferi as a cause of Lyme disease.

gloved hand pulling blood vile from several dozen. pulled vile says borrelia

Because of the mobility of people, different borrelia species are circulating around the world. This contributes another layer of difficulty to accurate diagnosis. It is becoming evident that other species are much more common than once thought.

Signs and Labs

Bull’s-Eye Rash (Erythema Migrans)

The classic bull’s-eye rash is signified by redness extending outward from the tick bite site with an outer, more prominent red ring. Symptoms of Lyme disease associated with a history of tick bite and bull’s-eye rash are the most reliable way to diagnose infection with borrelia, but even that is far from being absolute.

There are likely other types of microbes that can cause a bull’s-eye rash. And remember that more than half of people with Lyme disease won’t have a classic presentation of a bull’s-eye rash, and only one in 10 bull’s-eye rashes are associated with the presence of borrelia in the blood.

Blood/Tissue Culture

The most definitive test for proving the presence of a microbe is growing it in a lab from a tissue or blood sample. Because borrelia exists in such low concentrations in blood and tissues, and because borrelia is so difficult to grow under artificial conditions, cultures are generally not useful for diagnosing Lyme disease.

EIA tests (ELISA and ELFA)

This tests the host’s blood for antibodies produced against borrelia. The Centers for Disease Control (CDC) defines this test as an important screening test for Lyme disease. But in clinical practice, most healthcare providers who treat Lyme disease find that this Lyme disease test has poor predictive value and limited usefulness. It has no value for diagnosing persistent or chronic Lyme.

PCR for B. burgdorferi

Short for polymerase chain reaction, PCR tests directly for borrelia DNA in the host’s blood, tissues, or urine. Historically, PCR has had limited accuracy, but improvements in the technique are positioning PCR for microbial DNA as the future of testing. At some point, it may be possible to define a person’s entire microbiome.

For now, testing is available for the most common species of borrelia and many common species of coinfections with other stealth microbes. Testing is most accurate during acute infection and much less precise during chronic infection.

Many companies are offering microbial DNA testing, but a few are leading the charge. One, DNA Connexions, tests DNA in either blood or urine specimens for Borrelia burgdorferi and 10 of the most common coinfections. Testing kits are available online for $650.

Western Blot

The Western blot for Borrelia burgdorferi relies on the production of antibodies by the host’s immune system for different parts (antigens) of the bacteria. Antibody production may not kick in for several days to weeks after an infection has been acquired, and it’s dependent on the host’s ability to mount an immune response.

The Western blot test may provide a more accurate diagnosis of Lyme disease than most other available tests, but testing is more valuable for the late acute stage than with chronic illness. In addition, the test is oriented toward a diagnosis of Borrelia burgdorferi — not other species of borrelia that may cause Lyme disease.

Because borrelia shares antigens with other bacteria, multiple positive antibodies (called bands) are required for a true positive test. The Western blot is performed for both IgM and IgG antibiotics in an effort to separate acute from chronic illness.

IgM Antibody Response

IgM antibodies show acute Lyme disease. Testing can be positive as early as one week after infection and remains positive for six to eight weeks after initial exposure. CDC guidelines require two positive bands out of three (bands 23-25, 39, 41). But IGeneX labs add three extra bands (31, 38, 83-93), making it a more sensitive test. Note that bands 31 and 38 were removed from the CDC criteria during the development of an unsuccessful vaccine and were never replaced.

IgG Antibody Response

The IgG antibody becomes present a few months after initial infection. IgG antibodies are more indicative of chronic disease. CDC guidelines require five positive bands out of 10 (18, 23-25, 28, 30, 39, 41, 45, 58, 66, 83-93). However, the IGeneX criteria is two bands out of those same six. Note: Band 41 is specific for the flagella (tail) of spirochetes, but it is not absolutely specific for borrelia.

False Test Results

Acute viral infections can cause false-positive results. Recent data reported from IGeneX shows that some Lyme patients may have only restricted IgM response to Borrelia burgdorferi. Because Lyme patients have different immune systems, only approximately 70% of those with Lyme disease will generate a positive Western blot. Patients who test positive for rheumatoid factor or Epstein-Barr virus may have false-negative tests.

IGeneX Western Blot is around $125. IGeneX is now offering PCR testing for Borrelia miyamotoi (associated with relapsing fever) for between $265 and $295, as well as immunofluorescence testing (FISH) for bartonella, babesia, anaplasma, ehrlichia, and rickettsia.

Aperiomics

Aperiomics testing uses metagenomic sequencing with blood samples, tissue swabs (oral and nasal), urine specimens, or fecal samples to identify every known bacteria, virus, fungus, and parasite — their database alone contains more than 37,000 microorganisms.

Petri dishes with samples for DNA sequencing,3d rendering.

Aperiomics tests for both Lyme disease and coinfections, but it will likely come with a hefty price tag. Since stealth microbes often hide in various tissues throughout the body, the company recommends testing kits that collect blood, swab, urine, and fecal samples, which can cost upwards of a few thousand dollars.

Remember that no test is entirely definitive, and the results might not change the trajectory of your treatment. Before you splurge on costly testing, talk with your healthcare provider about how new information can be used to advance your recovery.

ArminLabs

Developed by Armin Schwarzbach, MD, PhD, ArminLabs offers Lyme testing for several species of borrelia. The tests measure such markers as T-cell function (Elispot), B-cell function (IgA, IgM, and IgG antibodies), and natural killer cells (CD57 and CD56). Additionally, they offer testing for several coinfections, viruses, parasites, and fungi. A typical panel of tests could cost several hundreds of dollars.

Direct Tick Testing

If you kept the tick that bit you, it is possible to have the tick checked for certain microbes. Though not a medical diagnostic tool, tick testing helps to identify whether or not the tick is infected with Borrelia burgdorferi. Some companies test for other borrelia species and coinfections, but no test covers all possible tick-borne disease.

Testing from TickReport ranges from $50 for a basic panel of borrelia species to $200 for a more comprehensive panel for borrelia species and coinfections.

Also, IGenex and ArminLabs have tick-test kits, which look for pathogens like borrelia, tick-borne relapsing fever (TBRF), babesia, anaplasma, ehrlichia, bartonella, and rickettsia.

Finally, local or state agencies, such as universities, may offer tick testing at little to no cost as part of research and data collection projects. But availability often depends on funding and differs from state to state.

Conventional Medical Solutions

In the acute stage of Lyme disease, antibiotics are the appropriate standard of care. During the first two weeks after a tick bite, there is an opportunity to reduce the concentration of microbes within the host using conventional antibiotics before the microbes disseminate deeper into tissues.

Blue medication, pills and blister pack from above on grey wooden background. Top view, frame. Painkillers, tablets, generic pills, drugs.

Healthcare professionals routinely recommend 100 mg of doxycycline taken twice daily for 2 to 3 weeks. Metronidazole (500 mg) or tinidazole (500 mg) taken twice daily can be added to cover borrelia in a cyst form (borrelia bacteria that coats itself with a protein as a protective measure against antibiotic therapy) or for a wider range of possible coinfections.

Some providers prescribe clindamycin as an oral antibiotic treatment, which has a high association with overgrowth of Clostridium difficile in the gut (a pathogen that causes bloody diarrhea). Clindamycin should only be used topically or intravenously.

Because 10% to 20% of people treated for acute Lyme disease will continue to have lingering symptoms, some healthcare providers may consider turning to a combination drug regimen like that mentioned in the journal Discovery Medicine. For example, the research indicates an antibiotic cocktail of daptomycin, doxycycline, and ceftriaxone was able to eradicate borrelia in mice. While the study is certainly encouraging for improved treatment outcomes, human clinical trials are still needed to determine the safety and efficacy of the three-drug cocktail.

It’s unlikely antibiotic therapy will ever eliminate all of the microbes; it just helps to give the immune system the upper hand. After the microbes have disseminated into tissues, antibiotic therapy is less likely to eradicate the infection.

Aside from antibiotics, a healthy immune system is essential for preventing chronic disease. If symptoms like fatigue or migrating arthritis persist, repeat antibiotics generally provide a transient benefit or no benefit at all.

Natural Solutions for Borrelia

The best approach to overcoming chronic Lyme disease is one that suppresses harmful microbes, supports immune system functions, enhances the body’s innate healing properties, and has a low potential for toxicity. Enter herbal therapy.

When it comes to chronic Lyme disease, herbs are essential components of getting well. Herbal therapy works for a number of reasons, including:

  • Herbs enhance immune function and healing, a necessary key to getting well.
  • Herbs contain antimicrobial, anti-inflammatory, antioxidant, and other health-enhancing properties without causing harm to the body.
  • The antimicrobial properties of herbs also support the friendly bacteria of your microbiome.
  • Multiple herbs can be used to gain overlapping benefits because the potential for toxicity is very low.
  • Many herbs provide activity against bacteria, viruses, protozoa, and yeast — characteristics not found in synthetic antibiotics.
  • Herbs and other natural therapies can slowly etch away at any biofilms (clusters of bacterial microorganisms that stick to surfaces) that are present; some herbs enhance the ability of the immune system to do the work.
  • Herbs have the ability to balance hormones and improve energy and stress tolerance.

Which herbs are the best options to support the body’s healing efforts? The following natural remedies will assist you on your road to recovery.

cats claw wood

Cat’s Claw

Native to the Amazon, cat’s claw contains immune-modulating properties to calm an overtaxed immune system and decrease inflammation. The herb is a staple among Lyme disease protocols due to its antimicrobial qualities. It has historical use in easing arthritis pain as well.

Suggested dosage: 400-800 mg two to three times daily (inner bark standardized to 3% alkaloids or 10:1 concentrate inner bark is preferred). It is especially important to take this herb with food, as it is activated by stomach acid. If you take acid-blocking drugs, cat’s claw won’t have a significant impact on you.

Side effects: The herb is generally well tolerated, but occasional stomach upset has been reported.

andrographis white flower

Andrographis

With antibacterial, antiviral, and antiparasitic properties, andrographisdefends against a wide range of microbes. The multi-tasking herb has immune-enhancing, cardioprotective, and liver-protective qualities. Like cat’s claw, andrographis is a mainstay among natural Lyme protocols.

Suggested dosage: 200-800 mg (extract standardized to 10-30% andrographolides) two to three times daily

Side effects: Approximately 1% of people who take andrographis develop an allergic reaction with whole-body hives and itching skin. This is a higher percentage than most other herbs. The reaction will resolve gradually over several weeks once the herb has been discontinued.

japanese knotweed white flowers

Japanese Knotweed

Used for centuries in traditional Asian medicine, Japanese knotweed has powerful antimicrobial activity and may fight against a range of stealth microbes. Additionally, the herb crosses the blood-brain barrier, which can be useful for addressing neurological Lyme disease. It also protects the central nervous system, contains anti-inflammatory properties, and supports immune function.

Suggested dosage: 200-800 mg Japanese knotweed (standardized to 50% trans-resveratrol) two to three times daily

Side effects: Exercise caution when using Japanese knotweed if you’re taking anticoagulants — resveratrol has blood-thinning properties. Avoid the herb if you’re pregnant.

garlic bulbs on dark wood

Garlic

Since the beginning of recorded time, garlic has been used for medicinal purposes. The active ingredient in garlic is called allicin, and it contains antiprotozoal, antiviral, and antifungal properties. Additionally, it assists in supporting the immune system and balances the flora of the microbiome.

Suggested dosage: 180-1200 mg of stabilized allicin product two to three times daily (dosage is dependent on the garlic preparation used)

Side effects: Although raw garlic can cause stomach upset, stabilized allicin products are associated with few side effects and are generally well tolerated.

orange reishi mushroom

Reishi Mushroom

Considered a medicinal mushroom, reishi is a strong adaptogen known for its antimicrobial and immune-modulating properties. It helps to mitigate inflammatory cytokines and supports the immune system’s ability to deal with pathogenic microbes. Reishi offers protective qualities to the liver and heart as well.

Suggested dosage: 1-2 grams (1000-2000 mg) whole mushroom powder or 150-500 mg standardized extract (minimum 20% beta-glucans preferred) two to three times daily.

Side effects: Typically, reishi is extremely well tolerated with rare side effects and no known toxicity.

purple chinese skullcap flowers

Chinese Skullcap

This herb has antimicrobial properties, dulls cytokines, and bolsters immune health. Chinese skullcap works synergistically with other herbal remedies to enhance their effectiveness. It also has naturally-occurring melatonin, which may help to induce sleep.

Suggested dosage: 400-1000 mg two to three times daily. Root extract, preferably 3-year old plant with pronounced yellow color, standardized to >30% baicalin is preferred. (Note that American skullcap does not offer the same antimicrobial properties and should not be substituted.)

Side effects: Even at high doses, side effects are rare and most often limited to gastrointestinal discomfort.

The Bottom Line

Depending on the stage at which you’ve been diagnosed with Lyme disease, you may require a combination of conventional and natural solutions to get a handle on borrelia and potential coinfections and get well. The most important part of recovery is making a long-term commitment to yourself. Although it may take several months to begin experiencing a change in your health, if you stay committed, better health is certainly within reach.

Dr. Rawls is a physician who overcame Lyme disease through natural herbal therapy. You can learn more about Lyme disease in Dr. Rawls’ new best selling book, Unlocking Lyme. You can also learn about Dr. Rawls’ personal journey in overcoming Lyme disease and fibromyalgia in his popular blog post, My Chronic Lyme Journey.

REFERENCES
1. Buhner SH. Healing Lyme: Natural Healing and Prevention of Lyme Borreliosis and Its Coinfections. Raven Press. Silver City, N.M. Copyright 2005.
2. Diagnosis and Testing. Centers for Disease Control and Prevention website. https://www.cdc.gov/lyme/diagnosistesting/index.html
3. Feng J, Li T, Yee R, et al. Stationary phase persister/biofilm microcolony of Borrelia burgdorferi causes more severe disease in a mouse model of Lyme arthritis: implications for understanding persistence, Post-treatment Lyme Disease Syndrome (PTLDS), and treatment failure. Discov Med. 2019 Mar;27(148):125-138. PMID: 30946803
4. Fesler MC, Shah JS, Middelveen MJ, Du Cruz I, Burrascano JJ, Stricker RB. Lyme Disease: Diversity of Borrelia Species in California and Mexico Detected Using a Novel Immunoblot Assay. Healthcare (Basel). 2020;8(2):97. Published 2020 Apr 14. doi: 10.3390/healthcare8020097
5. Lyme disease. Centers for Disease Control and Prevention website. https://www.cdc.gov/lyme/index.html
6. Parola P, Raoult D. Ticks and tickborne bacterial diseases in humans: an emerging infectious threat. Clin Infect Dis. 2001 Mar 15;32(6):897-928. doi: 10.1086/319347
7. Steere AC, Coburn J, Glickstein L. The emergence of Lyme disease. J Clin Invest. 2004;113(8):1093-1101. doi: 10.1172/JCI21681
 
_______________________
 
**Comment**
 
Very good article.  Just a few points for consideration:
 
  1. I cringe whenever I hear the word “rare” being used regarding any aspect of Lyme/MSIDS.  They’ve been using this word with abandon since Lyme was “discovered” over 40 years ago and they’ve had to recant that word often.  Since doctors are not actively looking for tick-borne illness, and are woefully uneducated on how to diagnose clinically, as well as the fact testing is so abysmal but still heavily relied upon, there is no way of truly discerning prevalence. It might be “rarely ” reported on in the literature, but that is world apart from what happens in the real world.  Words matter.  We desperately need post-mortem work done:  https://madisonarealymesupportgroup.com/2018/04/13/chronic-lyme-post-mortem-study-needed-to-end-the-lyme-wars/  For a great read:  https://madisonarealymesupportgroup.com/2020/11/21/can-tick-borne-diseases-be-fatal-what-you-should-know-about-tick-related-deaths/  and https://madisonarealymesupportgroup.com/2019/12/21/patients-can-die-when-lyme-carditis-is-not-treated/
  2. Regarding the issue of persisting symptoms, that too has been very under-reported for the same reasons.  Our public ‘authorities’ won’t even admit persistence exists, and patients are falling through the cracks like cookie crumbs.  How can prevalence be estimated when testing misses over 70% of cases?  For a great read on the numbers of those that go on to suffer with symptoms:  https://madisonarealymesupportgroup.com/2019/02/25/medical-stalemate-what-causes-continuing-symptoms-after-lyme-treatment/
  3. Dr. Rawls states that it is highly unlikely antibiotics will ever eradicate the Lyme organism entirely.  I could say the same, exact thing about herbs or ANY other treatment as Lyme/MSIDS is relapsing and persistent in nature and extremely resistant and stealthy.  I DO agree it often takes many things to get on top of this illness and that keeping an open mind about treatment is imperative.  Like so many other health issues, obtaining balance in the body is also a key with tick-borne illness.  Unfortunately, these pathogens overwhelm the body and they need to be seriously dealt with before you can ever hope to regain homeostasis.  So while antimicrobial treatment is not the only key to treatment, it’s an important one.

For more:  https://madisonarealymesupportgroup.com/2016/02/13/lyme-disease-treatment/

https://madisonarealymesupportgroup.com/2020/06/26/new-treatments-for-lyme-disease-on-the-horizon/

https://madisonarealymesupportgroup.com/2020/11/03/success-of-prescription-alternative-medicine-lyme-treatments/

 

“Stay of Action” Filed Against FDA to STOP Approval of COVID Vaccine For Using Faulty PCR Tests in Trials

https://healthimpactnews.com/2020/stay-of-action-filed-against-fda-to-stop-approval-of-covid-vaccine-for-using-faulty-pcr-tests-in-trials/

Nov. 27, 2020

“Stay of Action” Filed Against FDA to STOP Approval of COVID Vaccine for Using Faulty PCR Tests in Trials

by Brian Shilhavy
Editor, Health Impact News

An ADMINISTRATIVE STAY OF ACTION has been filed with the Department of Health and Human Services and Food and Drug Administration (FDA) for the new Pfizer COVID vaccine that has been submitted for “emergency use authorization” (EUA).

It is widely expected that the FDA is going to grant EUA fast-track approval to Pfizer’s experimental COVID vaccine within days.

The STAY OF ACTION is a Petition for Administrative Action Regarding Confirmation of Efficacy End Points of Phase III Clinical Trials of COVID19 Vaccines.

The STAY OF ACTION is based upon the faulty PCR tests that were used in the vaccine trials:

Before an EUA or unrestricted license is issued for the Pfizer vaccine, or for other vaccines for which PCR results are the primary evidence of infection, all “endpoints” or COVID-19 cases used to determine vaccine efficacy in the Phase 3 or 2/3 trials should have their infection status confirmed by Sanger sequencing, given the high cycle thresholds used in some trials. High cycle thresholds, or Ct values, in RT-qPCR test results have been widely acknowledged to lead to false positives.

Dr. Sin Hang Lee

The Petitioner of this ADMINISTRATIVE STAY OF ACTION is Dr. Sin Hang Lee, a pathologist and founder of Milford Molecular Diagnostics, a CLIA-certified diagnostic laboratory in Milford, Connecticut.

Dr. Lee is a world-renowned expert on DNA sequencing-based diagnostics. He has trained and taught in some of the world’s most prestigious institutions and has published scores of scientific articles in peer-reviewed journals.

He recognized very early on that the PCR tests and other tests fast-tracked by the FDA were not accurate in identifying SARSCoV-2 RNA, and even sent a letter, back in March, to Dr. Margaret Harris and Dr. Eduardo Guerrero of the World Health Organization, and Dr. Anthony Fauci at the National Institute of Allergies and Infectious Diseases of the National Institutes of Health (NIH), explaining why the tests to detect SARS-CoV-2 RNA were generating false positives and negatives.

You can read his March 22, 2020 letter here. He explained that a two-phased test would “guarantee no-false positive results” based on his research and published work from Japan.

According to Attorney Mary Holland of Children’s Health Defense, he never received a reply from the WHO or the NIH. To this day, they continue to use faulty tests to identify COVID.

So here we are now at the end of November, 2020, and the FDA appears to be ready to grant EUA fast-track approval to COVID vaccines that have gone through Phase I, II, and III vaccine trials, all using these faulty COVID tests.

In Dr. Lee’s ADMINISTRATIVE STAY OF ACTION, he recognizes the great risk for harm on the American public if the vaccine trials are approved based on these faulty tests.

Petitioner and the public will suffer irreparable harm if the actions requested herein are not granted, because once the FDA licenses this COVID-19 vaccine, both governments and employers may make this product mandatory (in general, or for airline or international travel) or may recommend it for widespread use.

If the assignment of cases and non-cases during the course of the trial is not accurate, the vaccine will not have been properly tested. If the vaccine is not properly tested, important public policy decisions regarding its use will be based on misleading evidence. The medical and economic consequences to the nation could hardly be higher.

The New York State Bar Association has already issued a report on COVID-19 recommending that, “a vaccine subject to scientific evidence of safety and efficacy be made widely available, and widely encouraged, and if the public health authorities conclude necessary, required…”

Thus, it is reasonable to suspect that COVID-19 vaccines, including the Pfizer vaccine, could become mandatory. Without the FDA assuring proper efficacy trials of the vaccine now, the Petitioner and the public may not have the opportunity to object to receiving the vaccine, which was approved based on currently deficient and unreliable clinical trial data.

How likely is it that HHS and the FDA will grant this stay and deal with the PCR testing deficiencies before issuing emergency use fast-track approval to the Pfizer vaccine?

Not very likely at all, unless the public puts pressure on them to be more transparent and deal with these testing deficiencies, that top scientists all around the world now are speaking out against. See:

“Pandemic is Over” – Former Pfizer Chief Science Officer Says “Second Wave” Faked On False-Positive COVID Tests
German Lawsuit Against “FactCheckers” Will Force Them To Prove Legitimacy of COVID Tests

Dr. Peter Marks is the head of the FDA’s Center for Biologics Evaluation and Research, and will be the main person to make the decision of whether or not to issue an EUA for the Pfizer COVID vaccine. He recently told the press that “Americans can expect a very open process” in their evaluation of the experimental vaccine. (Source.)

We need thousands if not tens of thousands of Americans to contact Dr. Peter Marks and let him know the public is watching, and that we want the FDA to consider Dr. Lee’s ADMINISTRATIVE STAY OF ACTION and respond to it.

Here is Dr. Marks’ public contact info:

A Strong Warning to the U.S. Military about Operation Warp Speed

Karl-Brandt-Nuremberg-Doctors-Trial

War Crimes Tribunal at Nuremberg and the “Doctors Trial.” Adolf Hitler’s personal physician, 43-year old Karl Brandt. Brandt was also Reich Commissar for Health and Sanitation, and was indicted by the U.S. prosecution with 22 other Nazi doctors. Brandt was found guilty of participating in and consenting to using concentration camp inmates as guinea pigs in horrible medical experiments, supposedly for the benefit of the armed forces. He was sentenced to death by hanging along with 6 other doctors who received death sentences. Image Source.

If you are a member of the military who will soon be called upon to participate in Operation Warp Speed and help distribute the new experimental COVID vaccine, be careful that you do not end up on the wrong side of history!

Just claiming to be “following orders” if massive deaths and injuries result from this experimental vaccine may not save you!

That is what many of the Nazi doctors in Germany who served under Hitler tried to claim, but during the Nuremberg trials, and specifically the “Doctors Trial” in 1946-1947, twenty of the twenty-three defendants were medical doctors, and were accused of having been involved in Nazi human experimentation and mass murder.

Of the 23 defendants, seven were acquitted and seven received death sentences; the remainder received prison sentences ranging from 10 years to life imprisonment.

What they did under German law, or maybe “emergency orders” during war time, was probably perfectly “legal” at the time, but after the Hitler regime was overthrown those who committed these “legal” actions that resulted in murder and crimes against humanity, were brought to justice after the war.

Dr. Peter Marks and Dr. Stephen Hahn would also do well to just not blindly excuse Dr. Lee’s ADMINISTRATIVE STAY OF ACTION, because Dr. Lee appears to have close ties to Attorney Mary Holland, currently the Counsel for Children’s Health Defense and former Professor of Law at NYU, and one of the nation’s top attorneys when it comes to vaccines.

Mary Holland works now for Attorney Robert F. Kennedy, Jr., who himself has become one the top attorneys in the world taking on Big Pharma.

He currently has 4 lawsuits filed against pharmaceutical giant Merck, for their approval of the HPV vaccine, Gardasil, which has destroyed the lives of so many young people due to being fast-tracked into the market.

The work of Dr. Sin Hang Lee and his DNA sequencing-based diagnostic testing on the HPV Gardasil vaccine found DNA fragments in the vaccine, something that Merck and the FDA had denied. See:

Fighting Academic Censorship on Gardasil Vaccine Research, Dr. Sin Hang Lee Challenges Medical and Scientific Community to Debate in Open Forum

His work in identifying these problems with the Gardasil vaccine led Japan to stop recommending the vaccine as part of their national vaccination program.

Here is a warning from a former Military Commander regarding current Commanders taking part of Operation Warp Speed, and the legal risks of doing so, published at Children’s Health Defense.

Former Officer Warns Military of Pitfalls Surrounding COVID Vaccine Mandate

Fast tracking the SARS-CoV-2 vaccine for a probable military mandate creates unparalleled dilemma for commanders who will face prodigious legal, medical, safety and ethical questions.

By Pam Long
Children’s Health Defense

As the former commanding officer of the Headquarters and Headquarters Detachment of the 36th Medical Evacuation Battalion, I recommend urgent caution for military commanders with orders to have all soldiers vaccinated with the experimental SARS-CoV-2 vaccine.

My concerns include the legality of a mandate, lack of treatment protocols and surveillance for adverse reactions, and a research-based risk assessment.

Legal challenges to a SARS-CoV-2 vaccine mandate

Under Emergency Use Authorization, state governments cannot mandate the SARS-CoV-2 vaccine in the civilian sector. A military mandate would require demonstration that the military sector had a compelling justification for a mandate. Healthy, young service members are not an at-risk group as they are not obese, not over the age of 65 and do not have comorbidities that cause complications from respiratory diseases.

The SARS-CoV-2 vaccine currently is not approved by the U.S. Food and Drug Administration (FDA). Even with a pending warp-speed FDA approval in the next month, the military, which still hasn’t rectified the failures, summarized here, of its Anthrax Vaccine Immunization Program (AVIP) isn’t in a position to implement a safe SARS-CoV-2 program. The Pfizer and Moderna SARS-CoV-2 vaccines, both of which use new mRNA technology, have much more potential for reactogenicity than the anthrax vaccine.

In short, federal courts have set precedent that mandating experimental vaccines in the military is illegal. As I wrote in a previous article:

“In 2008, the federal court affirmed that the FDA, [U.S. Department of Health and Human Services] HHS and [Department of Defense] DOD allowed an illegal AVIP program by mandating an experimental anthrax vaccine for military personnel that was not licensed for use against inhalation anthrax, nor approved for use by a presidential waiver.”

The illegal anthrax vaccine mandate caused adverse health outcomes in thousands of service members, triggered a retention crisis among pilots and imposed disciplinary actions under the Uniform Code of Military Justice against service members who refused an experimental and highly reactogenic vaccine.

All of these outcomes are likely to reoccur under a SARS-CoV-2 mandate. The HHS distribution plan will allow for millions of people to take the SARS-CoV-2 vaccine within a short period of time before any signals of adverse reactions are identified.

A military mandate would also have to demonstrate compelling reason to remove the right of service members to vaccine exemption by confirming with blood titers testing that they have antibody immunity.

Virologists at the La Jolla Institute of Immunology reported to the New York Times in November 2020 regarding coronavirus:

“Eight months after infection, most people who have recovered still have enough immune cells to fend off the virus and prevent illness, the new data show. A slow rate of decline in the short term suggests, happily, that these cells may persist in the body for a very, very long time to come.”

The researchers reported that natural immunity can last years.

Policy on treatment protocols and surveillance for adverse reactions

Commanders should reject any plan to mass vaccinate service members with the SARS-CoV-2 vaccine without an active surveillance policy in writing to review.

That policy should include a phased roll-out of the vaccine, a screening form for contraindications, vaccine exemptions (for medical contraindication, religious and personal belief accommodations, and those who are immune), education for service members on how to report adverse reactions to the Defense Medical Surveillance System, and training for medical providers on safe vaccine storage along with treatment protocols for adverse reactions.

The lack of established treatment protocols for immune backfiring known as Antibody Dependent Enhancement, when antibodies enhance uptake of the virus instead of neutralizing, should set off alarms for this entire mRNA vaccine program.

Review of the research-based risk assessment

Commanders should demand to see a research-based risk assessment from DOD on the SARS-CoV-2 vaccine. This risk assessment should be compared to the alternative “no vaccine mandate” course of action for a virus with a 99.9% survival rate.

Some of the hazards previously identified in mRNA animal research include liver damage in ferrets, enhanced respiratory disease in mice and ADE lung damage in monkeys. Furthermore, service members of child-producing ages, both male and female, should be informed that developmental and reproductive toxicity has not been established in this vaccine.

Since the U.S. has sidestepped identifying mitigating controls in animal trials for COVID vaccines, then the research implores that all humans should be screened for potential vaccine-induced autoimmunity, and health providers to be prepared for both excessive swelling and pathological clotting.

Safety precautions, as outlined in the study “mRNA Vaccines — a New Era in Vaccinology,” include:

“However, recent human trials have demonstrated moderate and in rare cases severe injection site or systemic reactions for different mRNA platforms. Potential safety concerns that are likely to be evaluated in future preclinical and clinical studies include local and systemic inflammation, the biodistribution and persistence of expressed immunogen, stimulation of auto-reactive antibodies and potential toxic effects of any non-native nucleotides and delivery system components.

A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity.

Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken.

Another potential safety issue could derive from the presence of extracellular RNA during mRNA vaccination. Extracellular naked RNA has been shown to increase the permeability of tightly packed endothelial cells and may thus contribute to oedema. Another study showed that extracellular RNA promoted blood coagulation and pathological thrombus formation.

Safety will therefore need continued evaluation as different mRNA modalities and delivery systems are utilized for the first time in humans and are tested in larger patient populations.”

Medical ethics require patients’ informed consent in treatment 

Given that the SARS-CoV-2 vaccine is designed to reduce symptoms and not to prevent infection or transmission, the military lacks a compelling justification for a vaccine mandate for members who are not at risk of virus complications.

This virus does not pose the fatality risks of anthrax or smallpox biological weapons in 2001. There has not been an “imminent risk” established within the military regarding COVID19 over the past six months, during which time  the virus has downgraded in virulence.

In accordance with medical ethics, the chain of command is required to give service members choice in medical treatment with well-established efficacy and demonstrated safety. In 2005, the Journal of Virology reported that hydroxychloroquine was a “potent” treatment for SARs coronavirus, in “Chloroquine Is a Potent Inhibitor of SARS Coronavirus Infection and Spread.”

Zinc was also established in 2010 to inhibit coronavirus and block replication of virus cells. Trace element zinc is revered as “Nature’s Gift to Fight Unprecedented Global Pandemic COVID-19” in 2020 research and is associated with reduced in-hospital mortality for COVID-19.

In conclusion, the fast tracking of the SARS-CoV-2 vaccine for a probable mandate in the military will result in an unparalleled dilemma for commanders, with prodigious legal, medical, safety and ethical considerations that will clash with the DOD decision makers who have historically favored pharmaceutical vaccine contracts over medical choices of individuals.

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.

Pam Long is graduate of USMA at West Point and is an Army Veteran of the Medical Service Corps. She served as a medical intelligence officer for NATO Stabilization Forces.

Read the full article at Children’s Health Defense.

Here are the Contact Details again for the FDA to urge them to address the issues in Dr. Lee’s ADMINISTRATIVE STAY OF ACTION.

Dr. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research – email: Peter.Marks@fda.hhs.gov– Phone: 240-402-8116

Dr. Stephen Hahn, Director of the FDA – email: Stephen.Hahn@fda.hhs.gov – Phone (Main FDA #): 1-888-463-6332 – Twitter account: @SteveFDA

Tell them America does not want an experimental COVID vaccine until there are accurate tests available to identify SARS-CoV-2! Until then, they need to grant Dr. Lee his “Stay of Action“!

Looking Back on Her Teen Years of Lyme-Related Pain. (Life’s Better Now!)

https://www.lymedisease.org/teen-lyme-pain-lifes-better-now/

Looking back on her teen years of Lyme-related pain. (Life’s better now!)

Flawed NIH Mask Study & Continued Media Spin On Hospital “Overcrowding”

https://thehighwire.com/videos/nih-mask-article-seriously-flawed/  7 Min Video Here

NIH MASK ARTICLE SERIOUSLY FLAWED

Francis Collins, Director of the National Institutes of Health (NIH) recently published a paper making bold claims about the efficacy of #masks, claiming that over 130,000 lives could be saved by ‘masking up.’ Digging deeper- it appears that the data used by Collins has serious flaws. Study here:  https://pubmed.ncbi.nlm.nih.gov/33097835/  Find out more with Del Bigtree and Jefferey Jaxen in the video in the top link.

In brief:

  • The paper was written by The Institute for Health Metrics and Evaluation (IHME) which was launched in 2007 – funded mainly by the Gates Foundation and the state of Washington.  
  • In 2017, the Gates Foundation invested another $279 MILLION.
  • The IHME paper incorrectly states only 49% were wearing masks.
  • The Wall Street Journal published the article, “Case of Mask Mandate Rests on Bad Data” which shows that nearly 80% were wearing masks by July and that it has hovered in the high 70% and low 80% ever since. (YouGov/Economist tracking poll)  https://www.wsj.com/articles/case-for-mask-mandate-rests-on-bad-data-11605113310
  • Carnegie Mellon University also shows mask usage exceeded 80% in 41 of 50 states as of Sept and today that’s up to 44 states.
  • CA and the Northeast has mask usage that exceeds 90%.
Once again, flawed data is being used but everything hinges upon it.

https://www.pnas.org/content/117/44/27076#ref-9  Other variables not considered in another mask study by Zhang et. al.

Other important mask findings:

  1. wearing double-layered masks at ALL times indoors and outdoors except while eating or sleeping
  2. social distancing of 6 feet on an island where they were not allowed to leave 
  3. denied access to things that could provide surface transmission
  4. routinely washing hands
  5. receiving most instruction and exercises outdoors
  6. sleeping in double-occupancy rooms with daily cleaning of sinks
  7. sanitizing bathrooms after each use with bleach wipes
  8. cleaning dining hall with bleach after each platoon had eaten
  9. supervising all movement of recruits, implementing unidirectional flow – with designated entry and exit points to minimize contact
  10. undergoing daily temperature and symptom screening
  11. enforcing quarantine measures by the same 6 instructors

    YET, DESPITE HUNDREDS IF NOT THOUSANDS OF CADETS LIVING LIKE THE ‘BOY IN THE BUBBLE,’ NONE OF THIS WORKED, JUST AS IT FAILED TO WORK WITH ARMY RECRUITS AT FORT BENNING.

Lastly, Collins (head of NIH) and Fauci (head of NIAID) both have severe conflicts of interest and should not be trusted.  
Collins recently stated:

“The cavalry is coming,” he said. “The vaccines are working. Biotechnology and this hard work of industry and academia and NIH has paid off in a dramatically rapid fashion, that we have never seen anything quite like it before. It usually takes eight years to get to this point.”  https://www.newsmax.com/us/nih-francis-collins-coronavirus-mask/2020/11/17/id/997504/

Yet, there is no proof of any of this being true.  All we have to date are press releases by vaccine manufacturers that are based on incomplete data.

“We do have some particular stake in the intellectual property” for the Moderna vaccine stated Francis Collins, the director of NIH, in a revelatory recent Economic Club panel discussion. “One of the vaccines– the one that’s furthest along– what started, actually, at the federal government in our own Vaccine Research Center at NIH– then worked with a biotechnology company called Moderna to get to where we are now, with very impressive Phase I results and getting ready to go into a large-scale trial as early as July. That one, of course, we do have some particular stake in the intellectual property. Others, though, come from companies who’ve invested their efforts into getting them to the point where they might now be ready for a trial,” Collins stated.

35113486893_f1b12cba74_cFrancis Collins in the center surrounded by Bill Gates and Anthony Fauci

As to the supposed “overcrowding of hospitals due to COVID:

https://healthimpactnews.com/2020/are-hospitals-really-over-crowded-due-to-covid-sick-patients/  Video within with Dr. Yeadon (respiratory expert) who discusses “over-crowded” hospitals and explains that this is simply seasonal, and happens every year around this time. 

Excerpts:

One of the most incredible things happening right before everyone’s eyes, is the subversion of data by the Covid Tracking Project, the CDC, media, and numerous other sources.

Why is this and what are they doing? They use trickery when revealing numbers, so as to manipulate the numbers, and convince everyone that things are far worse than they actually are.

What are Some Real Reasons Hospitals are Over-crowded Right Now?

1. Seasonal: As Dr. Yeadon points out and as Corey demonstrated with her stats, we are now into the yearly “flu season” where hospitals normally become much busier this time of year, especially in the Northern Hemisphere where daylight hours decrease along with Vitamin D levels, and cold weather increases.

2. Fear: The media and Big Pharma have produced a culture of fear to justify their medical tyranny, and fear harms and kills people. Walking outside and seeing everyone wearing facemasks, for example, perpetuates this culture of fear. Statistics clearly show that the lockdowns have increased rates of suicide, drug and alcohol consumption, domestic violence, etc. 

3. Staffing shortages: As we saw during the first lockdowns, many hospitals saw a huge REDUCTION in patients, which led to medical staff layoffs. And for the medical staff that remains in hospitals this time around, if they test positive for COVID with the false PCR test, they must stay at home and self-quarantine.  (Even if they don’t have symptoms)

I also posted an article about this very issue back in September.

https://madisonarealymesupportgroup.com/2020/09/25/the-only-circuit-break-in-the-pandemic-we-need-now-is-from-the-governments-doom-mongering-scientific-advisers-who-specialize-in-causing-panic-and-little-else-say-prof-carl-henneghan-and-dr-tom/

Doctors Hennegan and Jefferson point out that between now and Dec. doctors see a:

  • four-fold increase in consultations in general practice in a GOOD Year
  • they see an 8 fold increase in an epidemic year 
  • 50% increase in deaths between now and January
But it’s all being blamed on COVID.
It’s all a big, fat numbers game to keep everyone in perpetual fear.

LymeMIND Novel Treatments: Making Sense of Treatments for Tickborne Illness

http://

Hosted by “Icahn School of Medicine at Mount Sinai proudly supported by the Steven & Alexandra Cohen Foundation

5th Annual LymeMIND Virtual Conference 2020 Saturday, October 10th

Novel Treatments Making sense of all the treatment options
  • John Aucott, MD, Associate Professor, Director, Lyme Disease Research Center Johns Hopkins University School of Medicine
  • Tania Tyles Dempsey, MD, ABIHM, Founder, AIM Center For Personalized Medicine
  • Richard Horowitz, MD, Medical Director, Hudson Valley Arts Center
  • Andrew Petersen, DO, Chief of Staff Officer
Forum Health What are the differences in current treatment options

CDC vs. ILADS?

What are the critical time points from tick bite to chronic symptoms for patients to consider? What is the latest experience and research on treatment options?

______________________

**Comment**

Scroll to 5:40 to hear about Chronic Lyme treatment.

Dr. Petersen makes the simple, straightforward statement that we wouldn’t send someone home from the hospital with pneumonia after a course of treatment. They would be sent home after they are off the ventilator and they can breathe well.

Logical.

I write about this phenomenon here:  https://madisonarealymesupportgroup.com/2020/11/06/the-proof-is-in-the-pudding-my-letter-to-the-tbdwg/  Simple and straightforward.  I was sick, I got treatment, now I am well and do not suffer with symptoms any longer.  Please understand; however, that this treatment used multiple antibiotics and modalities simultaneously for over 5 years, and I relapsed TWICE necessitating 2-3 month treatment each time.  Each re-treatment got me better than I was before.  Hence: the proof is in the pudding.  Cause & effect.

I will say that this improvement isn’t linear and often is baffling in that you typically feel much worse before you feel better and you have to treat long, hard, and smart – taking into account diet, supplements, hormones, and the kitchen sink.  Many rabbit holes to go down.  Lazy people need not apply.  This is going to test you like nothing else – even your sanity at points.

Since this is such an individualized difference we all have different things to go after and attack, which makes it harder for doctors/researchers to standardize.  Again, lazy people need not apply.

BUT DON’T EVER, EVER GIVE UP!

Be bull-doggishly tenacious about your health and have hope.