Archive for the ‘Treatment’ Category

Post-Infectious Fatigue & Your Vagus Nerve

https://www.lymedisease.org/post-infectious-fatigue-vagus-nerve/

LYME SCI: Post-infectious fatigue and your vagus nerve

By Lonnie Marcum

Nov. 3, 2021

In 2013, the pain management clinic at a large teaching hospital diagnosed my then-15-year-old daughter with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). This was after 10 months of being referred to many pediatric specialists, none of whom could find an answer to her mysterious illness.

One of the hallmarks of ME/CFS is post-exertional malaise—profound fatigue following activity that is not restored by rest. Fatigue is also the most common symptom reported in patients with Lyme disease. (Aucott 2013, Johnson 2014)

At the time of my daughter’s diagnosis, she was mostly bedbound. An hour of homework would require a week of recovery. She had many symptoms of Lyme disease (fatigue, headache, light sensitivity, memory loss, heart block, POTS, swollen knee, muscle pain, nausea…the list goes on) but three separate standard tests for Lyme were negative.

In the absence of a definitive diagnosis, patients are often lumped into the category of ME/CFS—a complex and disabling syndrome. First defined by the CDC in 1988, the symptoms of ME/CFS have been recorded for centuries. (Holmes, 1988)

The million-dollar question?

There is no question that many infectious agents can trigger chronic illness. Past pandemics with infection-triggered chronic fatigue include: Russian influenza 1889, polio 1916, SARS-CoV-1 2003, Zika 2015, Ebola 2016, and more recently, COVID 2019.

But not everyone who contracts these diseases becomes chronically ill. As PolyBio researcher Amy Proal, PhD, said at the 2021 LymeMind conference, “The million-dollar question is why? Why do some patients go on to develop long-term, chronic symptoms and others do not?”

Even more puzzling is why do patients infected with completely different pathogens (viruses, bacteria, parasites) have so many of the same flu-like symptoms?

For example, the pathogens that cause COVID-19 (SARS-CoV-2, a virus) and Lyme disease (Borrelia burgdorferi, a bacterium) are vastly different. However, the chronic symptoms they leave behind are nearly identical: fatigue, brain fog, headaches, sensory issues, cognitive impairment, memory loss, sleep impairment, heart issues, muscle and joint aches/pain. The primary difference here being the respiratory symptoms among those with COVID-19. (Proal & VanElzakker 2021)

During the LDA/Columbia Lyme Conference, Dr. John Aucott, of Johns Hopkins University, reviewed several potential causes of “long-haul” symptoms for infectious diseases such as Lyme disease and COVID-19. These include: 1) persistent antigens and/or persistent infection; 2) immune inflammation and dysregulation; 3) neural network alterations.

One pathway that links all three of these elements (infection, inflammation, nervous system) together is called the vagus nerve. And one theory gaining recognition is the vagus nerve infection hypothesis, first proposed by Harvard neuroscientist Michael VanElzakker in 2013. (VanElzakker, 2013)

Because we know that Borrelia can infect the brain and the cranial nerves, this theory may explain why some patients remain ill following treatment for Lyme disease. (Gadila, 2021)

What is the vagus nerve?

The vagus nerve is the tenth (X) of 12 cranial nerves originating in the brain, denoted as CN-X. It originates from a portion of the brain responsible for autonomic function.

Blausen.com staff (2014). “Medical gallery of Blausen Medical 2014”. WikiJournal of Medicine 1

The autonomic nervous system (ANS) is the part of the nervous system that functions without you having to think about it. It regulates bodily functions such as breathing, heart rate, digestion, and blood pressure.

The vagus is the longest cranial nerve in the body. It innervates (supplies nerves to) every major trunk organ including the pancreas, liver, spleen, heart and bladder, along with the gastrointestinal lining and lymph nodes (Kenny and Bordoni, 2019). The Latin word vagus means “wandering.”

Twenty percent of the vagus nerve fibers lead away from the brain into the body (efferent), while 80 percent of the nerve fibers send signals from various points in the body back to the brain (afferent).

The most important function of the vagus nerve is afferent signaling. This is information brought from the inner organs—such as gut, liver, heart, and lungs—to the brain. Thus, our inner organs are a major source of sensory information to the brain.

The limbic system, amygdala and insular cortex are important central regions that are affected by vagus nerve signals. These areas of the brain are involved in regulating emotions, behavior, memory, and energy.

How does the vagus nerve affect autonomic function?

The ANS is divided into the sympathetic nervous system and the parasympathetic nervous system.

The sympathetic nervous system (SNS) is often referred to as the “fight or flight” or “excitatory” system. It is a primitive system designed to respond and help you get out of danger.

Blausen.com staff (2014). “Medical gallery of Blausen Medical 2014”. WikiJournal of Medicine 1

The parasympathetic nervous system (PNS), commonly known as the “rest and digest” or “inhibitory” system, promotes the opposite response of the SNS.

Blausen.com staff (2014). “Medical gallery of Blausen Medical 2014”. WikiJournal of Medicine 1

Both the SNS and PNS are involved when you become sick. Because we cannot feel, smell or see pathogens, the body uses the vagus nerve to sense when we are ill and send a message to the brain. This message triggers an adaptive response to the infection called “sickness behavior” or the “sickness response.”

However, if the infection or inflammation persists, this sickness response can become chronic, resulting in ME/CFS type symptoms.

How the vagus nerve causes flu-like symptoms

When a pathogen is detected, mast cells and glial cells release inflammatory markers and cytokines that trigger an immune response. The vagus nerve senses these markers and sends a message to the brain.  This causes flu-like symptoms: fever, fatigue, headache, sleep problems, loss of appetite, muscle/joint pain, nausea, autonomic dysfunction, cognitive dysfunction, and others.

This constellation of symptoms causes a sickness response that is designed to make us rest. Ideally, during this rest period our body can use all its energy to fight the infection and recover from the illness. Farmers and pet owners may recognize such sickness behavior in their sick animals, as well.

For years, it has been thought that Borrelia spread to the nervous system via the blood stream. A recent publication indicates that central nervous system involvement in Lyme neuroborreliosis may be a result of Borrelia moving from the skin to the spinal cord via peripheral nerves. (Ogrinc, 2021)

The vagus nerve may be a pathway for this type of infection.

Vagus nerve infection hypothesis

The vagus nerve infection hypothesis theorizes that the chronic flu-like symptoms of ME/CFS are an exaggerated version of normal sickness behavior triggered by infection of the vagus nerve.

In theory, any infectious agent with a preference for nervous tissues (neurotropic) can cause a vagus nerve infection, including Borrelia.

The gut-brain axis

The gut is the largest organ innervated by the vagus nerve, making it a particularly important sensory organ. (Breit, 2018) Gut bacteria (both good and bad) communicate through the microbiota-gut-brain axis in a bidirectional way that directly involves the vagus nerve. (Bonaz, 2018)

A huge amount of data has highlighted a potential role of microbial dysbiosis (an imbalance of bacteria in the gut) in various chronic disorders (Lynch and Pedersen, 2016).

The standard treatment for Lyme disease involves the use of antibiotics, which can adversely affect gut bacteria. Researchers at Northeastern University are currently looking at how the microbiome may contribute to the chronic symptoms of Lyme.

Not only can imbalance of the microflora or microbiome in the gut cause inflammation that triggers the vagus nerve, but it can also contribute to a leaky blood-brain barrier contributing further to neurological and psychological symptoms in Lyme.

Treatment

Obviously, if there is an infection present it should be treated appropriately. Lyme disease is often accompanied with co-infections carried by the same tick, a separate tick bite, or possibly even a prior latent viral infection. Thus, treatment may involve antibiotics, anti-parasitics and antivirals.

As a benefit, some of the standard medications for Lyme disease have anti-inflammatory effects on the nervous system. However, not all of them are able to cross the blood-brain barrier.

For example, minocycline crosses the blood-brain barrier and in addition to anti-microbial activity, it has been shown to have anti-inflammatory, anti-apoptotic activities, inhibition of proteolysis, angiogenesis and tumor metastasis-inflammatory as well as neuro-protective properties. (Garrido-Mesa, 2013)

Self-Help

Following treatment, or even during treatment, if you are exhibiting symptoms of dysautonomia (dysfunction of the ANS), you may want to  try some of the non-prescription practices that worked for my daughter.

Another technique is the use of external (transdermal) vagus nerve stimulation, similar to a home TENS unit. (Diedrich 2021)

During the LymeMind conference, Dr. Sunjya Schweig, an integrative medicine specialist, tweeted this:

Stanley Rosenberg’s 2017 book “Accessing the Healing Power of the Vagus Nerve: Self-Help Exercises for Anxiety, Depression, Trauma, and Autism” offers a simple explanation of Stephen Porges’s polyvagal theory.

Rosenberg’s book draws on more than 30 years of his experience as a hands-on craniosacral therapist and Rolfer. He offers immediate self-diagnostic and treatment techniques that can be done from the comfort of your home.

Main takeaway

Whether you have an active infection or the remnants of a previous infection, the vagus nerve may be contributing to your ongoing symptoms. Learning to recognize those symptoms and adding a few simple self-help techniques may help in your healing journey.

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

Aucott JN, Rebman AW, Crowder LA, Kortte KB. Post-treatment Lyme disease syndrome symptomatology and the impact on life functioning: is there something here? Qual Life Res. 2013 Feb;22(1):75-84. doi: 10.1007/s11136-012-0126-6. PMID: 22294245; PMCID: PMC3548099.

Azcona Sáenz J, Herrán de la Gala D, Arnáiz García AM, Salas Venero CA, Marco de Lucas E. (2021) Atypical bacterial infections of the central nervous system transmitted by ticks: An unknown threat. Radiologia (Engl Ed). Sep-Oct;63(5):425-435. doi: 10.1016/j.rxeng.2021.07.002. PMID: 34625198

Bonaz, B., Bazin, T., & Pellissier, S. (2018). The Vagus Nerve at the Interface of the Microbiota-Gut-Brain Axis. Frontiers in neuroscience, 12, 49. https://doi.org/10.3389/fnins.2018.00049

Breit S, Kupferberg A, Rogler G and Hasler G (2018) Vagus Nerve as Modulator of the Brain–Gut Axis in Psychiatric and Inflammatory Disorders. Front. Psychiatry 9:44. doi: 10.3389/fpsyt.2018.00044

Coughlin et al. Imaging glial activation in patients with post-treatment Lyme disease symptoms: a pilot study using [11C]DPA-713 PET

Diedrich A, Urechie V, Shiffer D, Rigo S, Minonzio M, Cairo B, Smith EC, Okamoto LE, Barbic F, Bisoglio A, Porta A, Biaggioni I, Furlan R. (2021) Transdermal auricular vagus stimulation for the treatment of postural tachycardia syndrome. Auton Neurosci. Sept29;236:102886. doi: 10.1016/j.autneu.2021.102886. Epub ahead of print. PMID: 34634682.

Ford, L., & Tufts, D. M. (2021). Lyme Neuroborreliosis: Mechanisms of B. burgdorferi Infection of the Nervous System. Brain sciences, 11(6), 789. https://doi.org/10.3390/brainsci11060789

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

Garrido-Mesa, N., Zarzuelo, A., & Gálvez, J. (2013). Minocycline: far beyond an antibiotic. British journal of pharmacology, 169(2), 337–352. https://doi.org/10.1111/bph.12139

Holmes GP, Kaplan JE, Gantz NM, Komaroff AL, Schonberger LB, Straus SE, Jones JF, Dubois RE, Cunningham-Rundles C, Pahwa S (1988). “Chronic fatigue syndrome: a working case definition”. Annals of Internal Medicine. 108 (3): 387–89. doi:10.7326/0003-4819-108-3-387. PMID 2829679.

Johnson L, Wilcox S, Mankoff J, Stricker RB. 2014. Severity of chronic Lyme disease compared to other chronic conditions: a quality of life survey. PeerJ 2:e322 https://doi.org/10.7717/peerj.322

Kenny BJ, Bordoni B. (Updated 2021) Neuroanatomy, Cranial Nerve 10 (Vagus Nerve) In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK537171/

Lynch SV, Pedersen O. The Human Intestinal Microbiome in Health and Disease. N Engl J Med. 2016 Dec 15;375(24):2369-2379. doi: 10.1056/NEJMra1600266. PMID: 27974040.

McCusker, R. H., & Kelley, K. W. (2013). Immune-neural connections: how the immune system’s response to infectious agents influences behavior. The Journal of experimental biology, 216(Pt 1), 84–98. https://doi.org/10.1242/jeb.073411

Ogrinc, K., Kastrin, A., Lotrič-Furlan, S., Bogovič, P., Rojko, T., Maraspin, V., Ružić-Sabljić, E., Strle, K., Strle, F. (2021) Colocalization of radicular pain and erythema migrans in patients with Bannwarth’s syndrome suggests a direct spread of borrelia into the central nervous system, Clinical Infectious Diseases, ciab867, https://doi.org/10.1093/cid/ciab867

Proal AD and VanElzakker MB (2021) Long COVID or Post-acute Sequelae of COVID-19 (PASC): An Overview of Biological Factors That May Contribute to Persistent Symptoms. Front. Microbiol. 12:698169. doi: 10.3389/fmicb.2021.698169

VanElzakker MB. (2013) Chronic fatigue syndrome from vagus nerve infection: a psychoneuroimmunological hypothesis. Med Hypotheses. Sep;81(3):414-23. doi: 10.1016/j.mehy.2013.05.034. Epub 2013 Jun 19. PMID: 23790471.

VanElzakker MB, Brumfield SA and Lara Mejia PS (2019) Neuroinflammation and Cytokines in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A Critical Review of Research Methods. Front. Neurol. 9:1033. doi: 10.3389/fneur.2018.01033

Category:

Gut Health, Lyme, Pain Management, Treatment

ICU Doctor Files Lawsuit Against Hospital After Being Barred From Administering Safe & Effective COVID Treatments

https://covid19criticalcare.com/wp-content/uploads/2021/11/FLCCC-Marik-Case-Release-FINAL-Nov-9.pdf

FOR IMMEDIATE RELEASE
November 9, 2021
CONTACT: Press@FLCCC.net

World’s Leading ICU Doctor Files Lawsuit Against Hospital System After  Being Barred from Administering Safe and Effective COVID–19 Treatments

A Virginia Physician has been prohibited from using safe and time–honored medications in hospital while death rates from COVID–19 continue to mount

WASHINGTON, D.C. – Paul Marik, MD, one of the most highly published critical care physicians in the world and the Director of the ICU at Sentara Norfolk General Hospital, was recently told by Sentara Healthcare that he could no longer administer a range of highly effective COVID–19 treatments to critically ill patients—the same treatments he has successfully used to reduce COVID deaths in the ICU by as much as 50%. The result of the prohibition has been a sharp increase in patient mortality. Because Dr. Marik can no longer stand by while patients needlessly die without proper treatment, he has filed a lawsuit to allow him and his colleagues to administer the combination of FDA–approved drugs and other therapies that has saved thousands of critically ill COVID–19 patients in the last 18 months.

The Complaint filed today in the Circuit Court for the City of Norfolk, Virginia states that Sentara Healthcare is “preventing terminally ill COVID patients from exercising their right to choose and to receive safe, potentially life–saving treatment determined to be appropriate for them by their attending physician.” Under Virginia law, every patient has the right to receive treatment deemed appropriate for them by their attending physician, and terminally ill patients have the right to try investigational medicines that their treating physician recommends. Through its arbitrary prohibition of the COVID–19 treatment protocol developed by Dr. Marik and his colleagues, Sentara is violating the law and unjustly depriving critically ill patients of lifesaving treatment.

“This case is about doctors, having the ability to honor their Hippocratic Oath, to follow evidence–based medicine, and to treat our patients the best we know how. Corporations and faceless bureaucrats should not be allowed to interfere with doctor–patient decisions, especially when it can result in harm or death.” according to Paul Marik, MD, chief, Division of Pulmonary & Critical Care Medicine, Eastern Virginia Medical School, who practices in the Sentara Norfolk General Hospital. “I refuse to watch another patient die from COVID–19 knowing that I was not allowed to give them proven treatments that could have saved their life.”

According to an accompanying declaration from a renowned critical care specialist recently recognized by the United Nations for his life–saving work, Joseph Varon, MD, the COVID–19 treatment protocol developed by Dr. Marik and his colleagues, called the “MATH+ Protocol,” has achieved at least a 50% reduction in deaths from the virus in the hospitals where he serves as Chief of Staff.

“The Sentara Healthcare System’s prohibition of the MATH+ protocol is a threat to every doctor and every patient in the U.S.,” said Pierre Kory, president and chief medical officer of the Front Line COVID–19 Critical Care Alliance (FLCCC). “We know the protocol is effective. Patients who could have been saved by MATH+ are dying because of the hospital’s baseless restriction. We will continue to see more deaths that could have been prevented until the court takes action and orders the hospital to reverse course.”

The MATH+ protocol has been used all over the world to effectively treat patients with COVID–19. It is generally well–tolerated with no reports of adverse medical events. In its September 27 memo to employees, Sentara Healthcare System tried to justify prohibiting many of medications in the MATH+ protocol by claiming it “is not supported in peer–reviewed, published RCTs,”
(Randomized Controlled Trials). However, this claim is demonstrably false. Peer–reviewed published RCTs do support the use many of the medications Sentara has prohibited, including fluvoxamine and ivermectin.

“The FLCCC stands behind Paul 100%,” said Dr. Kory. “We take an oath as doctors to do no harm. I can’t think of a way of doing more harm to a patient than to not administer a treatment that you know can help them. No doctor should be forced to watch their patient die knowing that more could have been done to save them and that is exactly what Sentara is doing.”

About the Front Line COVID–19 Critical Care Alliance The FLCCC Alliance was organized in March 2020 by a group of highly published, world renowned Critical Care physician/scholars – with the academic support of allied physicians from around the world – to research and develop lifesaving protocols for the prevention and treatment of COVID–19 in all stages of illness. Their MATH+ Hospital Treatment Protocol – introduced in March 2020, has saved thousands of patients who were critically ill with COVID–19. Now, the FLCCC’s new I–Mask+ Prophylaxis and Early At–Home Outpatient Treatment Protocol with Ivermectin has been released – and is a potential solution to the global pandemic.

For more information: https://covid19criticalcare.com

________________

**Comment**

Doctors attempting to treat COVID are experiencing the same censorship, bullying, denial, and attacks that Lyme literate doctors have been experiencing for over 40 years.  Perhaps this will open up some eyes in medicine that the ‘powers that be’ control a narrative which forces doctors to treat a certain way. Perhaps people will begin to understand and appreciate the corruption in public health.  Perhaps this will bring the needed change in medicine that we’ve been waiting for.  I’m not holding my breath, but there’s always hope.

Category:

Activism, Treatment, Viruses

Clinical Presentation of Lyme Disease in Patients Living in Germany – Same Story, Different Country

https://danielcameronmd.com/presentation-lyme-disease-patients-germany/

Clinical presentation of Lyme disease in patients living in Germany

Lyme disease presentation in man from Germany holding his hands over his face.
In their article, entitled “Neuropsychiatric and Psychological Symptoms in Patients with Lyme Disease: A Study of 252 Patients,” Hündersen and colleagues describe the clinical presentation, diagnostic process and treatment regimens for 252 Lyme disease patients. [1]
By

The authors collected data via an online questionnaire from 252 Lyme disease patients and a control group of 267 healthy individuals living in Germany to examine the clinical presentation, including neuropsychiatric and psychological symptoms.

The findings revealed that “Lyme disease can cause diverse psychological and neuropsychiatric symptoms. These include limitations in quality of life, sleep, attention, and memory, as well as depressive symptoms.”

Time to diagnosis

The majority of the patients were diagnosed with Lyme disease based on ELISA (53.2%), Western blot (43.7%), and lymphocyte transformation test results (41.7%).

Out of the 252 participants, nearly half (45.5%) recalled an erythema migrans rash, while 74% recalled a tick bite “that possibly triggered Lyme disease.”

It took approximately 8 years to receive a diagnosis following the tick bite.

On average, patients visited almost 8 physicians to obtain a diagnosis.

It took approximately 8 years to receive a diagnosis following the tick bite.  Less than half (46%) received their diagnosis within the first 5 years after the onset of symptoms.

Co-infections

The majority of participants were not diagnosed with or tested for a co-infections.

“A total of 25% of the sample stated that they had (exactly one) co-infection,” the authors explain, while 15% reported having 2 co-infections.

“For patients that suffered from co-infections, Chlamydia infection was particularly common (34.9%), as was the Epstein–Barr virus (34.9%).”

Treatment

Out of the 252 participants, 168 received antibiotic treatment that lasted at least 3 weeks.

Symptoms improved for nearly 73% of these patients.

93% of participants reported a relapse of symptoms after the completion of antibiotic therapy.

“The type of treatment was oral in most cases (47.6%), or a combination of oral and intravenous therapy (48.8%),” according to the authors.

Intravenous antibiotic therapy was prescribed in only 3.6% of the cases.

Authors Conclude:

  • “It became clear that Lyme disease is often diagnosed very late.”
  • “It appears that people suffering from Lyme disease have significantly lower quality of life and sleep and show cognitive impairments when it comes to attention and memory.”
  • “This study shows that 3.1% of Lyme patients were satisfied with their lives and that 37% scored in the lower third of the quality-of-life scale.”
  • “It was also shown that Lyme patients tend to have depressive symptoms.”
References:
  1. Hündersen F, Forst S, Kasten E. Neuropsychiatric and Psychological Symptoms in Patients with Lyme Disease: A Study of 252 Patients. Healthcare (Basel). 2021 Jun 14;9(6):733. doi: 10.3390/healthcare9060733. PMID: 34198647; PMCID: PMC8232147.

________________

**Comment**

This article, right here, encapsulates dire issues that have remain untouched for over 40 years.

  • Abysmal testing is still relied upon for diagnosis
  • Having the EM rash and remembering a tick bite happen far less than we are being told
  • People are still diagnosed and treated late, even though everyone and their dog knows this is a problem
  • Eight years is a long time to suffer, allowing pathogens to travel everywhere in the human body causing untold damage
  • Three weeks of antibiotics is a complete JOKE and is laughable if the consequences weren’t so dire
  • Most were not tested for coinfections.  Since testing for coinfections is just as abysmal as for Lyme – these patients saved a lot of money.  The minus, of course, is not understanding that cases with coinfection involvement are far more difficult to treat and require far more medications for a longer period of time. Lyme literate doctors understand this fact and will diagnose and treat clinically (based upon symptoms – not tests alone)
  • The fact their symptoms improved in 3 weeks doesn’t mean they should end treatment.  In fact, for those with a brain, it indicates antibiotic treatment works and should be continued until they don’t work, and then, they should be changed, not stopped as coinfections often need addressing and require different meds
  • 93% relapsing should prove to the deniers once and for all that the measly 21 days of doxycycline clearly isn’t working. 
  • 93% relapsing should also put to rest the myth that only 10-2-% go onto suffer persistent symptoms. When you count those who were diagnosed and treated late, as these patients were, it is an astounding 60% that go on to suffer debilitating symptoms.
  • The life-altering, debilitating symptoms these poor people suffer with show that this 40-year old experiment must end.  This is barbarism on a scale similar to the Tuskagee experiment

Category:

Activism, Lyme, research, Treatment

Another Whistleblower Promptly Fired For Showing Pfizer Falsified Data. Got Science? Are You Sure?

**UPDATE Feb. 18, 2022**

Here is the case filing of the lawsuit against Pfizer:  https://www.documentcloud.org/documents/21206071-brook-jackson-lawsuit

Case 1:21-cv-00008-MJT Filed 01/08/21

Core allegations:

Making or Using False Records or Statements to Cause Claims to be Paid (31 U.S.C. § 3729(a)(1)(B)) 284.

  1. “From 2020 to the present, Defendants knowingly made, used, or caused to be made or used, false records or statements that were material to false and/or fraudulent claims paid or approved by the United States DoD. These false records or statements include the clinical trial protocol Pfizer submitted to the United States and the falsified source documents and data behind Defendants’ trial results and EUA application.

  2. By creating and carrying out their fraudulent schemes, Defendants knowingly and repeatedly violated Section 3729(a)(1)(B) of the False Claims Act. 286. Defendants’ false records were material to Pfizer’s claims for payment for the vaccine at issue. The United States DoD would not have paid Pfizer if it knew that the clinical trial protocol was not complied with by Defendants, because the protocol violations call the integrity and validity of both the entire clinical trial and Pfizer’s EUA into question.

  3. Defendants’ false records also went to the very essence of the bargain the United States contracted for. DoD contracted to purchase vaccines found effective by a valid clinical trial conducted according to the protocol submitted by Pfizer. The integrity of the entire clinical trial was compromised by the trial protocol violations, false source documents, and the false data that resulted, which calls the vaccine’s EUA into question. Had the United States DoD known of Defendants’ false records, it would not have paid Pfizer. 288. Defendants’ use, or causation of use, of material false records was a foreseeable factor in the United States DoD’s loss and a consequence of Defendants’ schemes. By virtue of Defendants’ actions, the United States DoD has suffered actual damages and is entitled to recover treble damages plus a civil monetary penalty for each false and/or fraudulent claim.”

    Access: Case 1:21-cv-00008-MJT Filed 01/08/21

https://www.bmj.com/content/375/bmj.n2635.full

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635

 
Paul D Thacker, investigative journalist
Author affiliations
Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management

On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection

Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated. (See link for article)

Important excerpt:

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Speaking off the record, other employees confirmed that the fired employee’s concerns were valid:
  • “Everything that you complained about was spot on.”
  • “I don’t think it was clean data. It’s a crazy mess.”
  • “I’ve never had to do what they were asking me to do, ever, It just seemed like something a little different from normal—the things that were allowed and expected.”
  • One employee with over 4-dozen clinical trials under her belt said she had never experienced such a “helter skelter” work environment.
  • Ventavia lacked enough employees to test trial participants who reported COVID-like symptoms, which is important because symptomatic COVID was the trial’s primary endpoint.  An FDA review showed that swabs were not taken from 477 people with suspected COVID.

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For more on Pfizer’s corruption:

https://live.childrenshealthdefense.org/shows/doctors-and-scientists-with-brian-hooker-phd  Video Here from Oct. 28, 2021

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Dr. Brian Hooker invites some of the leading voices in science and medicine to break down the studies and weigh in on the controversies so the rest of us have an opportunity to understand the science that drives public health policy and medical progress.

See previous episodes within link as well.

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“We See Clotting – NOT From Virus, but From Spike From ‘Vaccine’ Itself” & CDC Finally Weighs in On Natural Immunity

https://americasfrontlinedoctors.org/2/frontlinenews/we-see-clotting-not-from-virus-but-from-spike-from-vaccine-itself-aflds-medical-director-dr-ryan-cole/  Video Here (Approx. 1 Min)

‘We see clotting – not from virus, but from spike from vaccine itself’: AFLDS Medical Director Dr Ryan Cole

October 20, 2021

It doesn’t get much clearer than this.

These are not vaccines but clot shots.

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https://www.washingtonpost.com/health/2021/11/01/what-works-better-vaccines-or-natural-immunity/

CDC finds immunity from vaccines is more consistent than from infection, but both last at least six months

Naturally acquired immunity is at the center of a political fight over President Biden’s vaccine mandates.

It’s a question that scientists have been trying to answer since the start of the pandemic, one that is central to the rancorous political debates over coronavirus vaccine policies: How much immunity does someone have after recovering from a coronavirus infection, and how does it compare with immunity provided by vaccination?

The Centers for Disease Control and Prevention has weighed in for the first time in a detailed science report released with little fanfare Friday evening. Reviewing scores of research studies and its own unpublished data, the agency found that both infection-induced and vaccine-induced immunity are durable for at least six months — but that vaccines are more consistent in their protection and offer a huge boost in antibodies for people previously infected. (See link for article)

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**Comment**

Did you honestly believe the CDC would ever admit in 1,000 years that natural immunity is broader, more robust, and more effective than their dangerous, experimental, ineffective, unneeded lucrative shots (that aren’t vaccines), and that history and 15 studies clearly demonstrate?  Even a former CDC director points out the complete bias against natural immunity by stating that the FDA, without presenting any data, issued a public safety statement:

“while SARS-CoV-2 antibody tests play an important role in identifying people who have been exposed to the SARS-CoV-2 virus and may have developed an adaptive immune response, antibody tests should not be used to determine immunity or protection against COVID-19.”

Huh?

So it’s fine to use inaccurate tests to inflate COVID cases and deaths, but it’s not fine to use them to prove immunity. It’s also fine to change testing perimeters for the “vaccinated,” to make it appear they are not getting infected with COVID, when “breakthough” infections are common due to vulnerability to variants.  The“vaxxed” are being damaged from the injections, and even die from COVID. People are also dying due to the ineffective “Fauci protocol,”with some stating that “hospitals are modern day killing fields.” Despite Fauci are fed up with his filibustering.

Our corrupt public health ‘authorities’ happily spend your tax-dollars on grotesque Frankenstein, and dangerous research while continuing to make up science, bully dissenters, move goal-posts, change perimeters, and definitions, and lie with statistics without any oversight, to continue their narrative.

Remember, NIH developed the spike protein, which goes systemic in the body, crosses the blood, brain barrier, and has been determined to be a dangerous toxin. Also, remember our government is a vaccine manufacturer, completely in bed with Big Pharma.  It is also worth repeating that the U.S. federal government partially owns an mRNA COVID-19 “vaccine” and soon before their rollout the U.S. federal government ensured COVID-19 mRNA vaccines would be legal by changing the definition of vaccines to include mRNA technology.  This change occurred just weeks before the first “cases” broke out in the U.S. Mandates would have been much harder to impose without this change.  Coincidence?

Epidemiologists estimate over 160 million people worldwide have recovered from COVID-19. Those who have recovered have an astonishingly low frequency of repeat infection, disease, or death. Immunity from prior infection protects – plain and simple. Regarding the injections; however, one expert states:

It’s worrisome that vaccination appears to deplete neutralizing Abs against the Spike protein gained by infection. It’s puzzling that vaccination appears also to deplete neutralizing Abs against the RBD (receptor-binding-domain) SARS-CoV-2 protein because the vaccines do not target that protein.  – James Lyons Weiler

Further, governments are bound by Pfizer’s lucrative but secret indemnification agreement for which they must:

  • acknowledge efficacy and risks are unknown
  • put up sovereign assets and military bases
  • promise to not penalize Pfizer for deliver delays
  • exempt Pfizer from all civil liability
  • pay for everything (all damages, lawsuits, losses, penalties, fines, settlements, attorney’s fees, costs and expenses)
  • not apply domestic laws to the company
  • protect Pfizer against intellectual property theft, while they are free to use anyone else’s intellectual property
  • keep everything a secret for 10 years

It’s crystal clear why our government is censoring, maligning, and denying effective treatments for COVID and pushing the need for a “shot in every arm.” They have nothing to lose (except lives) and everything to gain.  It’s also crystal clear why they downplay natural immunity, and the fact mortality from COVID is similar to the yearly flu.  These inconvenient facts would cause “vaccine” hesitancy, and they can’t have that.  Meanwhile, they completely ignore the vast devastation from lockdowns, fearmongering, and the “Fauci protocol.”

The following has billowed out (and continues to billow):

Vaccines are approved without proper safety studies, and nobody knows the effects of the cumulative effect of getting multiple vaccines. Many do not realize that Bill Gates, while pushing vaccines around the world that have caused hundreds of thousands of girls from India to be sterilized, doesn’t vaccinate his own children.

How many more whistleblowers will it take?  When will people realize we are in the biggest propaganda scheme in history?

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Activism, Treatment, vaccines, Viruses