Archive for July, 2018

TBDWG Draft Report

This draft report now goes to various government agencies for review.

Draft report:  https://www.lymedisease.org/wp-content/uploads/2018/07/TBDWG-draft-report-pdf.pdf

Draft recommendations:  https://www.lymedisease.org/wp-content/uploads/2018/07/TBDWG-draft-recommendations.pdf

For more:  https://madisonarealymesupportgroup.com/2018/05/11/tbd-working-groups-subcommittee-reports-are-now-available/

https://madisonarealymesupportgroup.com/2018/07/25/tweets-of-7th-tbd-working-group-meeting/

https://madisonarealymesupportgroup.com/2018/05/16/summary-of-may-15-tbd-working-group-meeting-in-tweets/

Another Chinese Vaccine Scandal

https://thevaccinereaction.org/2018/07/vaccine-scandal-in-china-crosses-moral-bottom-line/

Vaccine Scandal in China Crosses “Moral Bottom Line”

Vaccine Scandal in China Crosses “Moral Bottom Line”

 

I wrote an article in 2016 titled “Should We Be Concerned About Vaccines Made in China?” in response to a growing scandal in China involving the sale of thousands vaccines that had been improperly stored and expired and sold illegally on the black market.1 As it turned out, it wasn’t thousands of faulty vaccines, but rather millions, including vaccines for encephalitis, hepatitis B, influenza, meningococcal meningitis, mumps, polio and rabies.2 3

That scandal continued throughout 2016 and resulted in the arrests of more than 300 people and the investigation of more than 170 government officials. It was followed in 2017 by a recall in China of more than 650,000 “substandard” DPT (diphtheria, pertussis, tetanus) vaccines produced by Chinese vaccine manufacturers Changchun Changsheng BioTech and Wuhan Institute of Biological Products.4 5 6

Now, there is another vaccine scandal that has broken in China involving the sale of at least 250,000 doses of “faulty” DPT vaccines produced by Changchun Changsheng Biotechnology of Jilin Sheng, China7 8 and the falsification of production and inspection data for 113,000 of its Vero cell-based human rabies vaccines.9 10 11

Reuters recently reported:

According to the China Food and Drug Administration, Changsheng fabricated production records as well as product inspection records, and arbitrarily changed process parameters and equipment12

TRT World Now, July 25, 2018

A statement released on July 22, 2018 by China’s Premier Li Keqiang characterized his country’s latest vaccine scandal as a violation of a “moral bottom line.”11 President Xi Jinping followed up those comments by saying that his administration has launched an investigation into the case “so as to scratch the bone and get rid of the poison.”13

It is unclear how many Chinese-made vaccines are circulating in the United States or how safe they are, so it is difficult to say whether Americans should be concerned about them. However, vaccines are pharmaceutical products, and we know that Chinese pharmaceuticals—notably the ingredients that go into those drugs—are being sold in the U.S. in large quantities. It has been reported that China has more than 500 companies registered to sell pharmaceutical ingredients in the U.S.14

The U.S. Food and Drug Administration (FDA) estimated a few years ago that 80 percent of the ingredients in pharmaceuticals produced by U.S. companies originated in China and India.1 15 That figure may well be higher today.

Moral bottom line? Poison?


References:

1 Cáceres M. Should We Be Concerned About Vaccines Made in China? The Vaccine Reaction Apr. 3, 2016.
2 Buckley C. China’s Vaccine Scandal Threatens Public Faith in Immunizations? The  New York Times Apr.  18, 2016.
3 Qiu J, Hu H, Zhou S, Liu Q.  Vaccine scandal and crisis in public confidence in China. The Lancet 387(10036); 2382 June 11, 2016.
4 Xinhua China sentences man for illegal vaccine trade. Xinhuanet Feb. 20, 2018.
5 TVR Staff. DPT Vaccines Recalled in China. The Vaccine Reaction Nov. 30, 2017.
6 Yiwen C. China’s FDA Says 650,000 Vaccines Failed National Standards. Sixth Tone Nov. 6, 2017.
7 Hernández JC. In China, Vaccine Scandal Infuriates Parents and Tests Government. The New York Times July 23, 2018.
8 Bloomberg New and Associated Press. Bio-tech execs taken away by Chinese police after 250,000 doses of defective vaccine sold. National Post July 24, 2018.
9 Lo K. Changsheng Bio-tech, the vaccine maker behind China’s latest public health scare. South China Morning Post July 24, 2018.
10 Liu A. Chinese rabies vaccine maker ordered to stop production over forged data. Fierce Pharma July 17, 2018.
11 Meixler E. Outrage in China Over Latest Vaccine Safety Scandal. TIME July 23, 2018.
12 Jourdan A, Ruwitch J. China police probe vaccine maker after scandal sparks fury. Reuters July 22, 2018.
13 Strong treatment needed to remedy vaccine system: China Daily editorial. China Daily July 23, 2018.
14 Palmer E. China drug exports to U.S. rise but companies struggle with quality. Fierce Pharma Aug. 30, 2016.
15 Marsteller D. As drug making goes global, oversight found lackingUSA Today Oct. 21, 2012.

 

MCAS, Vaccination, & Lyme/MSIDS

I repost the following article because Lyme/MSIDS patients have chronically high inflammation within the body and many struggle with MCAS as well.  Please read the following article and consider your own symptoms.  Discuss these with your doctor.

For more on MCAShttps://madisonarealymesupportgroup.com/2017/04/17/mast-cell-activation-syndrome-lymemsids/

https://madisonarealymesupportgroup.com/2018/03/13/mcas-lyme-msids/

https://madisonarealymesupportgroup.com/2018/03/26/the-agony-of-mcas/

https://madisonarealymesupportgroup.com/2018/04/04/more-about-healing-from-mcas/

https://madisonarealymesupportgroup.com/2018/04/19/what-to-eat-when-youre-allergic-to-everything/

Mast Cell Disease and Vaccination: Is There Increased Risk?

https://thevaccinereaction.org/2018/07/mast-cell-disease-and-vaccination-is-there-increased-risk/

Mast Cell Disease and Vaccination: Is There Increased Risk?

 

Do you or does someone you know have severe symptoms of itching, rashes, flushing, stomach or other body pain, frequent diarrhea, nausea, fatigue, brain fog, headache and severe allergies to certain foods, medications or insect stings that may include fainting episodes or anaphylaxis? Although it has been classified as a rare immune system disorder, there are indications that Mast Cell Activation Syndrome (MCAS) may be more prevalent than previously thought and people can suffer for years without being correctly diagnosed.1 With severe allergies and chronic inflammatory diseases increasing in populations around the world, scientists are investigating the association between mast cell dysregulation and various brain and immune system disorders ranging from asthma, inflammatory bowel disease and chronic fatigue syndrome to ADHD, depression, autism and cancer.2 3 4 5

What are Mast Cells?

Mast cells are often described as the body’s sentinels because they modulate and orchestrate the immune response and play a critical role in innate and adaptive immunity, as well as maintaining homeostasis in the body.6 7 Mast cells and basophils are types of white blood cells (granulocytes) that are made in the bone marrow. While basophils circulate in the blood, mast cells reside in tissues, primarily connective and mucosal tissues near blood vessels and nerves of the skin, gastrointestinal, respiratory and genitourinary tracts, and the brain. 9

Mast cells and basophils are part of the body’s first line of defense when responding to injury or foreign antigens, such as pathogenic bacteria, viruses, parasites, protozoa, fungi and toxins.10 During the immune system’s normal protective response to a perceived threat, mast cells can release over 200 potent pro-inflammatory mediators within seconds of activation, including histamine (amino acid product), heparin (anti-coagulant), tryptase (enzyme) and cytokines (cell signaling protein molecules).11 12

The activation of this normal protective inflammatory response to internal or external stress increases blood flow to the site of the infection or wound to aid in healing. Acute inflammatory responses are often accompanied by the four classic signs of redness, heat, swelling and pain, which eventually disappear as cells regenerate and inflammation resolves during the healing process.13 However, allergic inflammatory responses are also provoked by mast cell activation.14

What is Mast Cell Disease and MCAS?

Mast cell activation is common and helps combat threats to our health. However, when a dysregulated immune system overproduces mast cells or when mast cell activation is out of proportion to the perceived internal or external threat, it can compromise our health.

The most serious of mast cell activation diseases (MCAD) is systemic mastocytosis, which can develop when genetically altered mast cells infiltrate and accumulate in large numbers in major organ systems, such as the skin, liver and intestines.15 16 A rare form of MCAD is aggressive systemic mastocytosis, usually caused by somatic mutations in the KIT gene, which progresses rapidly and causes organ damage and failure.17 An even rarer form of mast cell disease is mast cell leukemia and mast cell sarcoma.18

Mast Cell Activation Syndrome (MCAS) is a common variation of mast cell disease and can be more or less severe depending upon epigenetic, environmental, lifestyle and other host factors. MCAS occurs when a normal amount of mast cells inappropriately and chronically release histamine and other pro-inflammatory mediators that can lead to persistent inflammation in one or more parts of the body. Over time, chronic inflammation can damage cells if inflammation cannot be resolved and every organ in the body can be affected.19

Systemic mastocytosis is estimated to affect 1 in 10,000 people. However, the prevalence of MCAS is not known and some researchers estimate the less serious forms of mast cell dysregulation could affect between 10 and 30 percent of populations.20 21

Symptoms of MCAS

Symptoms of MCAS can wax and wane and often various symptoms start in early childhood, although people generally do not get diagnosed for decades after symptoms appear. The effects of mast cell dysregulation can cause a plethora of diverse symptoms, depending on where the mast cells are activated in the body.

Common symptoms of MCAS can include fatigue; pruritus (severe itching); migraine; frequent nausea and diarrhea; allergic reactions to certain foods, medications, chemicals, insect bites and environmental antigens; chronic sinus congestion or dry cough; gastro-esophageal reflux disease (GERD); urinary tract infections; muscle cramping; feeling cold; sweating, especially at night; hair loss; dry eyes; conjunctivitis (pink eye); mouth ulcers (canker sores); dental decay; heart palpitations; inability to concentrate and brain fog; anxiety, depression and insomnia.22 23

When mast cells overeact to a benign substance as if it were a foreign antigen posing a serious threat, symptoms can be life threatening like when a person has an anaphylactic reaction to peanuts.24 Mast cell over-activation and release of large amounts of histamine in the body can be unpredictable, so people with MCAS are at risk of reacting to different foods, alcohol or medications at any time, leaving them uncertain as to when they might have another reaction to something they previously were not aware was a trigger for mast cell activation.25 Many people with MCAS carry an epi-pen with them in case of anaphylaxis.

Diagnosing mast cell disease is difficult and involves blood and urine testing and, less frequently, skin or bone marrow biopsy.26 Most medical doctors in general practice are not well informed about MCAS, while doctors specializing in functional medicine tend to be more familiar with symptoms. Functional medicine focuses on a personalized, integrative approach to investigating root causes of health problems by analyzing the unique genetic, epigenetic, biochemical, environmental and lifestyle factors that affect an individual’s immune function and influence the development of complex chronic diseases.

Because MCAS can present differently in different people, the goal is to identify individual triggers for mast cell activation, including food (such as gluten, dairy, baker’s yeast, shellfish, nuts, wheat, corn); or chemicals (alcohol, certain prescription medications, MSG, aspartame, artificial dyes, cleaning products); mold and spores; extreme heat or cold; vigorous exercise; stress or other potential triggers and avoid them.27 There are many unanswered questions about mast cell disease and few prescription drug treatments.28 There is evidence that certain flavonoids (such as Quercetin and Rutin) inhibit histamine release and expression of pro-inflammatory cytokines in mast cells. 29

MCAS and Chronic Disease

Because overactive mast cells release pro-inflammatory mediators causing widespread inflammation in the body, MCAS has been implicated in a number of diseases that involve chronic inflammation and immune dysfunction. There is evidence that MCAS is related to allergic/inflammatory diseases, autoimmune disorders, and autism spectrum disorder.30 31

Health problems that have been associated with MCAS include eczema, psoriasis, and other skin disorders; irritable bowel syndrome; small intestine bowel overgrowth (SIBO); interstitial cystitis (bladder pain syndrome); asthma; migraines; depression; anxiety; ADHD; Obsessive Compulsive Disorder (OCD); autoimmune diseases like rheumatoid arthritis, lupus and Hashimoto’s; cancer; peripheral neuropathy, multiple sclerosis; diabetes; obesity; endometriosis; infertility; fibromyalgia and postural orthostatic tachycardia syndrome (POTS), among others.32 33 34

Symptoms of Histamine Intolerance

Histamine is a neurotransmitter that facilitates communications between neurons throughout the nervous system. Histamine levels in the body help control the sleep and wake cycle and influence metabolism, thyroid function, reproduction and management of stress, as well as regulate body temperature, maintain fluid balance in the body and other important functions. Histamine can also increase permeability of the blood brain barrier.35

People with histamine intolerance lack sufficient levels of Diame oxidase (DAO), a gut enxyme, and histamine N-methyltransferase (HNMT), a liver enzyme, which break down and detoxify histamine in foods, medications or alcohol. When these enzymes fail to do their job, high levels of histamine circulate in the blood and cause histamine intoxication.36 Eating histamine-rich foods, drinking alcohol or taking prescription drugs that release histamine and or inhibit DAO or HNMT enzyme activity can cause high histamine levels and symptoms like diarrhea, headache, sinus congestion, heart palpitations, itching and flushing, low blood pressure and many other symptoms.

The symptoms of histamine intolerance and MCAS are similar and a person can have either histamine intolerance of MCAS or both. The main difference between the two is that histamine intolerance involves the triggering of high levels of histamine in the blood that cannot be efficiently detoxified, while MCAS involves dysregulated mast cells releasing not only histamine but multiple inflammatory and other types of mediators in tissues of the body.37

There is some evidence for genetic predisposition to histamine intolerance.  Like MCAS, histamine intolerance can be hard to diagnose even with blood and urine tests. Treatment for histamine intolerance focuses on avoiding histamine rich foods and alcohol or medications that block DAO or HNMT enzyme activity. Some people with histamine intolerance take DAO supplements to help the body break down histamine or take anti-histamines to control levels of histamine in the blood.38

MCAS and Autism Spectrum Disorder

Over the past decade, a number of reports and studies have linked Autism Spectrum Disorder (ASD) with immune dysregulation and chronic inflammation in the body, including in the brain.39 40 41  There is evidence that mast cell dysregulation is associated with Autism Spectrum Disorder (ASD).42 43

Some researchers have suggested that the relationship between immune response and brain function may be negatively affected when toxins cross the blood brain barrier during a critical point in neural development, causing neurotoxicity and immune dysregulation that disrupts the natural neuron pruning process and contributes to the development of autism spectrum disorders. 44 If the immune system is dysregulated, it can affect the formation and necessary removal of physical connections between neurons that is critical to maintaining healthy brain cell function.45

ASD children have a higher rate of allergies (30%) compared to neurotypical children (2.5%). Tufts University Professor Theodore Theoharides, PhD, MD, who has conducted extensive research into mast cell disorders, has published a series of studies on the association between MCAS and autism. The evidence he has provided suggests that overactive mast cells in the brain and gut triggered by non-allergic stimulus can lead to brain inflammation and chronic brain dysfunction with symptoms diagnosed as autism. Evidence that mast cells play a role in ASD is also supported by the fact that the hypothalamus, which regulates behavior and language, houses the majority of mast cells in the brain and people with ASD often have problems associated with language and behavior.46

What Are Co-Factors for Developing MCAS?

Currently, MCAS is not considered to be a genetically inherited disease but there is evidence for epigenetic predisposition to development of MCAS as it tends to run in families, albeit with varying degrees of severity and presentations in individuals within the same family.47 Perinatal stress, environmental exposures, DNA methylation, somatic genetic mutations and interactions between microbiota and mast cells have been proposed as contributing co-factors.48 49 50

According to University of Minnesota Professor Lawrence Afrin, MD, an oncologist and leading mast cell authority, mast cell disease can present with different manifestations and outcomes for each person because every person is unique:

“Conveying a new understanding that all mast cell disease features inappropriate mast cell activation, the new top level mast cell activation disease (MCAD) encompasses various types of rare mastocytosis and likely prevalent mast cell activation syndrome (MCAS). The apparent uniqueness in each patient with MCAD of constitutively activating mutational patterns in KIT and other mast cell regulatory elements likely is the principal driver of not only the specific clinical presentation, and therapeutic response profile, in each patient but also the great heterogeneity across this population.”51  

Inflammation and Vaccination

When the immune system repeatedly mounts an inappropriate acute inflammatory response to antigens or non-allergic substances, it can lead to unwanted chronic inflammation in the body that is common to a number of immune and neuroimmune system disorders.52 53 Vaccination stimulates an inflammatory immune response that promotes production of antibodies and the acquisition of artificial active immunity.54 However, unlike naturally acquired immunity that involves a normal inflammatory response producing both innate (cellular) and humoral (adaptive) immunity, most vaccines manipulate the immune system in way that only stimulates production of vaccine strain antibodies and humoral immunity.55

Because vaccine acquired artificial immunity is temporary, many vaccines contain adjuvants, such as aluminum or squalene, to stimulate a strong inflammatory response in the body, which involves mast cell activation.56 There is mounting scientific evidence that when individuals cannot tolerate hyper-stimulation of the immune system, the atypical inflammatory response to vaccination can remain unresolved, become chronic, and lead to allergy and autoimmunity.57

Vaccines contain many ingredients, including chemicals, virus like protein particles and heavy metals, such as aluminum adjuvants and mercury (Thimerosal) preservatives, as well as other substances that can cause inflammation.58 59 Mercury can activate and destabilize mast cells,60 61 which disrupts the blood brain barrier and makes it easier for mercury to enter the brain where it can remain for long periods of time.62 Even a low concentration of mercury has been shown to activate mast cell mediators in the brain. Scientists have demonstrated that Thimerosal-derived ethylmercury is a mitochondrial toxin and may damage mitochondrial DNA.63

Polysorbate 80 is a chemical emulsifier added to some vaccines. Polysorbate 80 has the ability to help deliver substances across the protective blood brain barrier and into the brain.64 When toxins enter the brain, mast cells are activated and cause inflammation.65 Polysorbate 80 has also been shown to increase histamine levels in animal studies.66

The first vaccine found to cause acute and chronic brain inflammation (acute and chronic encephalopathy) and permanent brain dysfunction was smallpox vaccine created by Edward Jenner in 1796.67 The first vaccine found to cause acute and chronic encephalopathy with permanent brain dysfunction that ranged from learning disabilities and behavior disorders to profound mental retardation was whole cell pertussis vaccine licensed in 1915 and combined in 1949 with diphtheria and tetanus vaccine to create DPT vaccine.68 69 Whole cell pertussis vaccine ingredients include pertussis toxin, endotoxin, aluminum and mercury.70

Cases of pertussis vaccine-related brain inflammation followed by development of autism were first described in the book DPT: A Shot in the Dark published in 1985.71 72

Is Mast Cell Disease a Risk Factor for Vaccine Reactions?

Mast cells play an important part in keeping the body healthy, but when they malfunction, can cause system wide chronic inflammation in the body that interferes with quality of life or can even cause death.

Dr. Afrin recently related the story of a patient,

“who in the first year of his life had been perfectly normal and then, within hours of his first DTP vaccine at age one, developed into just a terrible multi-system inflammatory mess, including essentially acute onset autism.” When he was 20 years old, biopsies tested positive for mast cells. He was subsequently treated for MCAS with remarkable improvement.73

Most babies in the U.S. are being given 25 doses of nine different vaccines (or more) by their first birthday and can receive eight or more vaccines simultaneously.74 As mentioned previously, there are ingredients in vaccines that provoke inflammatory responses in the body that involve mast cell activation.75

Although for the past several decades, most pediatricians and public health officials have rejected the possibility of a relationship between vaccination and the development of allergic and autoimmune disorders,76 the apparent increase in mast cell dysregulation in highly vaccinated populations deserves more in-depth investigation.

The two outstanding questions are:

  • Does repeated atypical manipulation of the immune system with multiple vaccines in early life trigger MCAS or development of histamine intolerance in genetically or epigenetically predisposed individuals?
  • Are individuals with undiagnosed MCAS or histamine intolerance at greater risk for suffering vaccine reactions, particularly if they have a personal or family history of allergy or autoimmunity?
There is urgent need for more basic science research into how and why MCAS and histamine intolerance occurs and whether vaccination is a co-factor in increasing individual risks for mast cell dysregulation.

References:

1 Cáceres M. Should We Be Concerned About Vaccines Made in China? The Vaccine Reaction Apr. 3, 2016.
2 Buckley C. China’s Vaccine Scandal Threatens Public Faith in Immunizations? The  New York Times Apr.  18, 2016.
3 Qiu J, Hu H, Zhou S, Liu Q.  Vaccine scandal and crisis in public confidence in China. The Lancet 387(10036); 2382 June 11, 2016.
4 Xinhua China sentences man for illegal vaccine trade. Xinhuanet Feb. 20, 2018.
5 TVR Staff. DPT Vaccines Recalled in China. The Vaccine Reaction Nov. 30, 2017.
6 Yiwen C. China’s FDA Says 650,000 Vaccines Failed National Standards. Sixth Tone Nov. 6, 2017.
7 Hernández JC. In China, Vaccine Scandal Infuriates Parents and Tests Government. The New York Times July 23, 2018.
8 Bloomberg New and Associated Press. Bio-tech execs taken away by Chinese police after 250,000 doses of defective vaccine sold. National Post July 24, 2018.
9 Lo K. Changsheng Bio-tech, the vaccine maker behind China’s latest public health scare. South China Morning Post July 24, 2018.
10 Liu A. Chinese rabies vaccine maker ordered to stop production over forged data. Fierce Pharma July 17, 2018.
11 Meixler E. Outrage in China Over Latest Vaccine Safety Scandal. TIME July 23, 2018.
12 Jourdan A, Ruwitch J. China police probe vaccine maker after scandal sparks fury. Reuters July 22, 2018.
13 Strong treatment needed to remedy vaccine system: China Daily editorial. China Daily July 23, 2018.
14 Palmer E. China drug exports to U.S. rise but companies struggle with quality. Fierce Pharma Aug. 30, 2016.
15 Marsteller D. As drug making goes global, oversight found lackingUSA Today Oct. 21, 2012.

Tuttle’s Response to the NEJM Article

Yesterday, I posted this:  https://madisonarealymesupportgroup.com/2018/07/26/tickborne-diseases-confronting-a-growing-threat/  (Please read the article in this link including my comments at the bottom before Tuttle’s response below so it will make more sense)

The one thing I didn’t deal with that I will point out now is this regurgitated number in the NEJM article of 10-20% of patients moving on to chronic/persistent Lyme.  The following informative article written by Lorraine Johnson points out this number to be considerably higher which corresponds to my experience as a patient advocate:  https://madisonarealymesupportgroup.com/2018/07/22/lyme-costs-may-exceed-75-billion-per-year/.  Excerpt below:

Besides the staggering financial cost to this 21st century plague, this paper, based on estimates of treatment failure rates associated with early and late Lyme, estimates that 35-50% of those who contract Lyme will develop persistent or chronic disease.

Let that sink in.

And in the Hopkins study found 63% developed late/chronic Lyme symptoms.
For some time I’ve been rankled by the repeated CDC statement that only 10-20% of patents go on to develop chronic symptoms. This mantra in turn is then repeated by everyone else.

While still an estimate, I’d say 35 to over 60% is a tad higher than 10-20%, wouldn’t you? It also better reflects the patient group I deal with on a daily basis. I can tell you this – it’s a far greater number than imagined and is only going to worsen.

Now for Tuttle’s response:

https://www.change.org/p/1120418/u/23062391?utm_medium=email&utm_source=petition_update&ut

PETITION UPDATE

Tickborne Diseases — Confronting a Growing Threat

Carl Tuttle
Hudson, NH
JUL 26, 2018 — Please see the letter below addressed to Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases (NIAID).

It would appear that the racketeering scheme to downplay the severity of Lyme disease is rampant throughout all government health agencies.

Letter to Anthony S. Fauci, M.D:

———- Original Message ———-
From: Carl Tuttle
To: Anthony.Fauci@nih.hhs.gov
Cc: catharine.paules@nih.hhs.gov, hilary.marston@nih.hhs.gov, Marshall.Bloom@nih.hhs.gov, comments@nejm.org, ddutko@hanszenlaporte.com, chris.smith@mail.house.gov, collin.peterson@mail.house.gov, jdrazen@nejm.org, info@massmed.org, president@massmed.org, mmsvp@massmed.org
Date: July 26, 2018 at 9:16 AM
Subject: Tickborne Diseases — Confronting a Growing Threat

Tickborne Diseases — Confronting a Growing Threat

Catharine I. Paules, M.D., Hilary D. Marston, M.D., M.P.H., Marshall E. Bloom, M.D., and Anthony S. Fauci, M.D. This article was published on July 25, 2018, at NEJM.org.
https://www.nejm.org/doi/full/10.1056/NEJMp1807870

Excerpt:

“Although most cases are successfully treated with antibiotics, 10 to 20% of patients report lingering symptoms after receiving appropriate therapy.”

July 26, 2018

Office of the Director,
National Institute of Allergy and Infectious Diseases (NIAID),
National Institutes of Health,
Bethesda, MD 20892
Attn: Anthony S. Fauci, M.D., Director

Dear Dr. Fauci,

There has been a thirty year fixation on the acute stage of Lyme disease (with bulls-eye rash) after early treatment however patients with a prolonged exposure to the pathogen before diagnosis and initial treatment are almost always incapacitated.

You know that untreated strep throat progresses to rheumatic fever causing irreversible heart damage. What happens to the Lyme patient who went months, years or decades before diagnosis? Dr. Neil Spector required a heart transplant after his Lyme went undiagnosed for four years while his laboratory tests (serology) were repeatedly negative. [1]

Singer/songwriter Kris Kristofferson was being treated for Alzheimer’s disease when discovering he had undiagnosed Lyme disease. [2]

Autopsy results identify the destructive nature of Borrelia as evident in Vicky Logan’s liver (nutmeg liver), kidneys, heart, lungs and brain. The patient died after the insurer refused additional IV antibiotic therapy. [3]

There is a growing patient population of this class of disabled patient who has been ignored for nearly four decades. Lyme disease is a life-altering/life-threatening infection misclassified as a low-risk and non-urgent health issue through an elaborate racketeering scheme as outlined in the SHRADER & ASSOCIATES, LLP racketeering lawsuit. [4] The U.S. Centers for Disease Control has aligned themselves with the seven defendants/academics named in this RICO lawsuit.
From your article:

“Nonserologic platform technologies may also improve diagnostic capabilities, particularly in identifying emerging pathogens. Two previously unknown tickborne RNA viruses, Heartland virus and Bourbon virus, were discovered by researchers using next-generation sequencing to help link organisms with sets of unexplained clinical symptoms.”

When Sanger sequencing identified a case of chronic Lyme disease, the CDC stopped all communication with the Director of Milford Molecular Diagnostics. [5], [6]

The recently published Middelveen paper reported persistent infection as the majority of patients were culture positive for infection even after multiple years on antibiotics so there was no relief from current antimicrobials. Some patients had taken as many as eleven different types of antibiotics. [7]
_______________________

Dr. Fauci; your “Perspective” published in the New England Journal of Medicine does not mention anything I have presented here so it would appear that you are caught up in this racketeering scheme to suppress the severity of a disease that is destroying lives, ending careers, causing death and disability while leaving victims in financial ruin. There are no Public Service Announcements informing the public that you could become horribly disabled or die from Lyme disease.

It is time to move Lyme disease to HIGHEST ALERT and remove the CDC’s stronghold over the progress to find a curative approach for the late stage Lyme epidemic. [8]

Acknowledgment and response to this letter is requested.

Respectfully submitted,

Carl Tuttle
Lyme Endemic Hudson, NH

Cc: Attorney Daniel Dutko of Hanszen Laporte
U. S. Representatives Chris Smith and Colin Peterson

 

Tickborne Diseases – Confronting a Growing Threat

https://www.nejm.org/doi/full/10.1056/NEJMp1807870

Tickborne Diseases — Confronting a Growing Threat

Catharine I. Paules, M.D., Hilary D. Marston, M.D., M.P.H., Marshall E. Bloom, M.D., and Anthony S. Fauci, M.D.

July 25, 2018, at NEJM.org.

Every spring, public health officials prepare for an upsurge in vectorborne diseases. As mosquito-borne illnesses have notoriously surged in the Americas, the U.S. incidence of tickborne infections has risen insidiously, triggering heightened attention from clinicians and researchers.

nejmp1807870_f1

Common Ticks Associated with Lyme Disease in North America.

According to the Centers for Disease Control and Prevention (CDC), the number of reported cases of tickborne disease has more than doubled over the past 13 years.1 Bacteria cause most tickborne diseases in the United States, and Lyme disease accounts for 82% of reported cases, although other bacteria (including Ehrlichia chaffeensis, Anaplasma phagocytophilum, and Rickettsia rickettsii) and parasites (such as Babesia microti) also cause substantial morbidity and mortality. In 1982, Willy Burgdorfer, a microbiologist at the Rocky Mountain Laboratories of the National Institute of Allergy and Infectious Diseases, identified the causative organism of Lyme disease, a spirochete eponymously named Borrelia burgdorferi. B. burgdorferi (which causes disease in North America and Europe) and B. afzelii and B. garinii (found in Europe and Asia) are the most common agents of Lyme disease. The recently identified B. mayonii has been described as a cause of Lyme disease in the upper midwestern United States. Spirochetes that cause Lyme disease are carried by hard-bodied ticks (see graphic), notably Ixodes scapularis in the northeastern United States, I. pacificus in western states, I. ricinus in Europe, and I. persulcatus in eastern Europe and Asia. B. miyamotoi, a borrelia spirochete found in Europe, North America, and Asia, more closely related to the agents of tickborne relapsing fever, is also transmitted by I. scapularis and should be considered in the differential diagnosis of febrile illness occurring after a tick bite.

Patterns of spirochete enzootic transmission are geographically influenced and involve both small-mammal reservoir hosts, such as white-footed mice, and larger animals, such as white-tailed deer, which are critical for adult tick feeding. The rising incidence and expanding distribution of Lyme disease in the United States are probably multifactorial, but increased density and range of the tick vectors play a key role. The geographic range of I. scapularis is apparently increasing: by 2015, it had been detected in nearly 50% more U.S counties than in 1996.

Lyme disease’s clinical manifestations range from relatively mild, nonspecific findings and classic erythema migrans rash in early disease to more severe manifestations, including neurologic disease and carditis (often with heart block) in early disseminated disease, and arthritis, which may occur many months after infection (late disease). Although most cases are successfully treated with antibiotics, 10 to 20% of patients report lingering symptoms after receiving appropriate therapy.2 Despite more than four decades of research, gaps remain in our understanding of Lyme disease pathogenesis, particularly its role in these less well-defined, post-treatment symptoms.

Meanwhile, tickborne viral infections are also on the rise and could cause serious illness and death.1 One example is Powassan virus (POWV), the only known North American tickborne encephalitis-causing flavivirus.3 POWV was recognized as a human pathogen in 1958 after being isolated from the brain of a child who died of encephalitis in Powassan, Ontario. People infected with POWV often have a febrile illness that can be followed by progressive and severe neurologic manifestations, resulting in death in 10 to 15% of cases and long-term sequelae in 50 to 70% of survivors.3 An antigenically similar virus, POWV lineage II, or deer tick virus, was discovered in New England in 1997. Both POWV subtypes are linked to human disease, but their distinct enzootic cycles may affect their likelihood of causing such disease. Lineage II seems to be maintained in an enzootic cycle between I. scapularis and white-footed mice — which may portend increased human transmission, because I. scapularis is the primary vector of other serious pathogens, including B. burgdorferi. Whereas only 20 U.S. cases of POWV infection were reported before 2006,3 99 were reported between 2006 and 2016. Other tickborne encephalitis flaviviruses cause thousands of cases of neuroinvasive illness in Europe and Asia each year, despite the availability of effective vaccines in those regions. The increase in POWV cases coupled with the apparent expansion of the I. scapularis range highlight the need for increased attention to this emerging virus.

The public health burden of tickborne pathogens is considerably underestimated. For example, the CDC reports approximately 30,000 cases of Lyme disease per year but estimates that the true incidence is 10 times that number.1 Multiple factors contribute to this discrepancy, including limitations in surveillance and reporting systems and constraints imposed by available diagnostics, which rely heavily on serologic assays.4 Diagnostic utility is affected by variability among laboratories, timing of specimen collection, suboptimal sensitivity during early infection, imperfect use of diagnostics (particularly in persons with low probability of disease), inability of a single test to identify coinfections in patients with acute infection, and the cumbersome nature of some assays. Current diagnostics also have difficulty distinguishing acute from past infection — a serious challenge in diseases characterized by nonspecific clinical findings. Moreover, tests may remain positive even after resolution of infection, leading to diagnostic uncertainty during subsequent unrelated illnesses. For less common tickborne pathogens such as POWV, serologic testing can be performed only in specialized laboratories, and currently available tests fail to identify novel tickborne organisms.
Such limitations have led researchers to explore new technologies. For example, one of the multiplex serologic platforms that have been developed can detect antibodies to more than 170,000 distinct epitopes, allowing researchers to distinguish eight tickborne pathogens.4 In addition to its utility in screening simultaneously for multiple pathogens, this assay offers enhanced pathogen detection, particularly in specimens collected during early disease. Further studies are needed to determine such assays’ applicability in clinical practice.

Nonserologic platform technologies may also improve diagnostic capabilities, particularly in identifying emerging pathogens. Two previously unknown tickborne RNA viruses, Heartland virus and Bourbon virus, were discovered by researchers using next-generation sequencing to help link organisms with sets of unexplained clinical symptoms. The development and widespread implementation of next-generation diagnostics will be critical to understanding the driving factors behind epidemiologic trends and the full clinical scope of tickborne disease. In addition, sensitive, specific and, where possible, point-of-care assays will facilitate appropriate clinical care for infected persons, guide long-term preventive efforts, and aid in testing of new therapeutics and vaccines.

In the United States, prevention and management of tickborne diseases include measures to reduce tick exposure, such as avoiding or controlling the vector itself, plus prompt, evidence-based treatment of infections. Although effective therapies are available for common tickborne bacteria and parasites, there are none for tickborne viruses such as POWV.

The biggest gap, however, is in vaccines: there are no licensed vaccines for humans targeting any U.S. tickborne pathogen. One vaccine that was previously marketed to prevent Lyme disease, LYMErix, generated an immune response against the OspA lipoprotein of B. burgdorferi, and antibodies consumed by the tick during a blood meal targeted the spirochete in the vector.5 Nonetheless, the manufacturer withdrew LYMErix from the market for a combination of reasons, including falling sales, liability concerns, and reports suggesting it might be linked to autoimmune arthritis, although studies supported the vaccine’s safety. Similar concerns will probably affect development of other Lyme disease vaccines.5

Historically, infectious-disease vaccines have targeted specific pathogens, but another strategy would be to target the vector.5 This approach could reduce transmission of multiple pathogens simultaneously by exploiting a common variable, such as vector salivary components. Phase 1 clinical trials are under way to evaluate mosquito salivary-protein–based vaccines in healthy volunteers living in areas where most mosquito-borne diseases are not endemic. Since tick saliva also contains proteins conserved among various tick species, this approach is being explored for multiple tickborne diseases.5

The burden of tickborne diseases seems likely to continue to grow substantially. Prevention and management are hampered by suboptimal diagnostics, lack of treatment options for emerging viruses, and a paucity of vaccines. If public health and biomedical research professionals accelerate their efforts to address this threat, we may be able to fill these gaps. Meanwhile, clinicians should advise patients to use insect repellent and wear long pants when walking in the woods or tending their gardens — and check themselves for ticks when they are done.
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**Comment**

While this article repeats much of the same verbiage that’s been repeated for years, particularly the vaccine push, they are ignoring the following:

  1. Many TBI’s are congenitally transmitted:  https://madisonarealymesupportgroup.com/2018/06/19/33-years-of-documentation-of-maternal-child-transmission-of-lyme-disease-and-congenital-lyme-borreliosis-a-review/https://madisonarealymesupportgroup.com/2018/07/24/congenital-transmission-of-lyme-myth-or-reality/https://madisonarealymesupportgroup.com/2018/02/26/transplacental-transmission-fetal-damage-with-lyme-disease/
  2. There is a real probability of sexual transmission:  https://madisonarealymesupportgroup.com/2018/02/06/lyme-in-the-southern-hemisphere-sexual-transmission/https://madisonarealymesupportgroup.com/2017/02/24/pcos-lyme-my-story/
  3. While they mention Ehrlichia, Anaplasma, Rickettsia, and Babesia, there are many other players that are hardly getting a byline.  For a list to date:  https://madisonarealymesupportgroup.com/2017/07/01/one-tick-bite-could-put-you-at-risk-for-at-least-6-different-diseases/.  This is an important issue because to date the medical world is looking at this complex illness as a one pathogen one drug illness when nothing could be further from the truth.  No one has done any research on the complexity of being infected with more than one pathogen.  It will reveal the CDC’s guidelines of 21 days of doxy to be utter stupidity.
  4. Also, worth mentioning is that only a few of these are reportable illnesses so there is absolutely no data on how prevalent any of this is.  Surveillance is a real problem.
  5. Regarding what ticks are where….this ancient verbiage needs to change.  Ticks are moving everywhere.  This is on record in numerous places:  https://madisonarealymesupportgroup.com/2018/07/16/ticks-that-carry-lyme-disease-are-spreading-fast/https://madisonarealymesupportgroup.com/2018/07/10/we-have-no-idea-how-bad-the-us-tick-problem-is/https://madisonarealymesupportgroup.com/2018/07/22/citizen-scientists-help-track-tick-borne-illness-exposure/
  6. No tick is a good tick.  They all need blood meals and have the potential to transmit disease.  
  7. This article is silent about the Asian Longhorned tick that propagates itself by cloning and can drain cattle of their blood.  Found in six states so far it was recently found on a child in New Jersey:  https://www.northjersey.com/story/news/environment/2018/07/24/bergen-county-nj-child-may-first-carrying-longhorned-tick-us/825744002/.  Word in the tick world is it had NOT bitten the child and tested negative for pathogens.  What is concerning is that it is known to transmit SFTS virus and Japanese spotted fever in Asia. This story is a reminder that this tick is NOT just a livestock problem and that a normal child going about a normal day with NO contact with livestock had this tick on her.  Another clear reminder that it is foolish to put any of this in a box.
  8. They need to emphasize that the “classic erythema migrans rash” while indicative of Lyme, is unseen or variable in many patients.
  9. Constraints in testing is a true problem but an even bigger problem is untrained and uneducated medical professionals.  This stuff may never test clearly.  Get over it.  Get trained to know what to look for!
  10. The Lyme vaccine was a bust.  It still is.  Unless safety concerns are dealt with we want nothing to do with any vaccine.
  11. All I know is that mosquitoes and Zika get more attention that this modern day 21st century plague that is creeping everywhere and is a true pandemic.  It still isn’t being seriously dealt with or researched.  What research is being done is same – o – same -o stuff we already know.  Study the tough stuff – the unanswered questions or things that are just repeated as a mantra for decades.
We need answers out here not repeated gibberish that isn’t helping patients.
Afterthought:

The one thing I didn’t deal with that I will point out now is this regurgitated number in the NEJM article of 10-20% of patients moving on to chronic/persistent Lyme. The following informative article written by Lorraine Johnson points out this number to be considerably higher which corresponds to my experience as a patient advocate: https://madisonarealymesupportgroup.com/2018/07/22/lyme-costs-may-exceed-75-billion-per-year/. Excerpt below:

Besides the staggering financial cost to this 21st century plague, this paper, based on estimates of treatment failure rates associated with early and late Lyme, estimates that 35-50% of those who contract Lyme will develop persistent or chronic disease.

Let that sink in.

And in the Hopkins study found 63% developed late/chronic Lyme symptoms.

For some time I’ve been rankled by the repeated CDC statement that only 10-20% of patents go on to develop chronic symptoms. This mantra in turn is then repeated by everyone else.

While still an estimate, I’d say 35 to over 60% is a tad higher than 10-20%, wouldn’t you? It also better reflects the patient group I deal with on a daily basis. I can tell you this – it’s a far greater number than imagined and is only going to worsen.