https://www.theguardian.com/personal-investments/ng-interactive/2018/oct/09/elena-delle-donne-wnba-lyme-disease-foundation

Great interactive article in link above on stats, prevention, symptoms, and the Elena Delle Donne Charitable Foundation.

https://www.ncbi.nlm.nih.gov/m/pubmed/30279260/

Ehrlichiosis masquerading as thrombotic thrombocytopenic purpura.

Chen D, et al. BMJ Case Rep. 2018.

Abstract

Ehrlichiosis is a rare tickborne illness that can manifest from an asymptomatic, self-limiting disease to a severe presentation with encephalopathy and renal failure. Ehrlichiosis is diagnosed largely based on patient history with confirmatory tests including peripheral blood smear, serology and PCR. Empiric treatment is warranted in patients with suspected tick bites as a delay in treatment can result in multiorgan failure. We discuss a case of ehrlichiosis that presented with the classic pentad of thrombotic thrombocytopenic purpura (TTP). A history of a tick bite was elicited and intravenous doxycycline 100 mg two times a day was initiated. Tick panel results revealed a positive Ehrlichia chaffeensis IgG and IgM titres, consistent with human monocytic ehrlichiosis. Autoimmune workup and antibodies to Borrelia burgdorferi were negative, and ADAMTS13 activity assay results were inconsistent with TTP. The patient completed 14 days of intravenous doxycycline and had an uneventful recovery.

PMID

30279260 [ – in process]

__________________________
**Comment**
Thrombotic Thrombocytopenic Purpura (TTP) causes tiny blood clots throughout your body.  This can block blood vessels and impede blood flow.  The clots can use up too many platelets which in turn can inhibit clot formation when you need it.
Symptoms include:
  • Purplish bruises (purpura) from no obvious cause
  • tiny red or purple spots that look like a rash
  • skin may turn yellowish (jaundice)
  • skin may look pale
  • fever
  • fatigue
  • confusion
  • weakness
  • headache
  • In very serious cases, a stroke, major internal bleeding, or a coma can occur
Warning!
In May 2017, an article in the CDC “Emerging Infectious Diseases” Journal, warns that ehrlichiosis infections are being “grossly underreported” in the U.S. with as many as 97-99% of infections going unrecognized. They are projecting that the actual number of annual cases could go as high as 1/2 the number of Lyme disease cases—which would mean we may already have over 150,000 cases of ehrlichiosis annually. (3)
Rickettsiae and Ehrlichia belong to a broad group of bacteria that can be spread by a tick bite. These infections can be transmitted alone or at the same time as Lyme disease and are commonly known as co-infections.

 

The Ehrlichia (E) group includes: (5, 6, 7, 8,)

  • chaffeensis: the cause of human monocytic ehrlichiosis (HME)
  • ewingii
  • muris-like (EML)

Symptoms
While some cases of ehrlichiosis are mild, the disease can be severe or fatal if not treated correctly, even in previously healthy people. Severe symptoms of ehrlichiosis may include difficulty breathing, respiratory failure, bleeding disorders, kidney or heart failure.

Because Ehrlichia infect white blood cells (the cells that fight infection), and mitochondria (the powerhouse of the human cell) the consequences of untreated infection may have long-lasting effects.(9) I often wonder if undiagnosed Ehrlichiosis isn’t responsible for some portion of the millions of people with the mysterious illness known as “Myalgic Encephalomyelitis” or “Chronic Fatigue Syndrome”.

Other symptoms of ehrlichiosis can include:

  • Fever/chills and headache (majority of cases)
  • Fatigue/malaise (over two-thirds of cases)
  • Muscle/joint pain (25% – 50%)
  • Nausea, vomiting and/or diarrhea (25% – 50%)
  • Cough (25% – 50%)
  • Confusion or brain fog (50% of children, less common in adults)
  • Lymphadenopathy (47% – 56% of children, less common in adults)
  • Red eyes (occasionally)
  • Rash (approximately 60% of children and 30% of adults)

Diagnosis And Treatment
Like other tick-borne diseases, diagnostic blood tests will frequently be false-negative during the first weeks of illness. And like other tick-borne diseases, treatment is most effective if started early. For this reason, healthcare providers must use their best clinical judgement and treat patients based upon early symptoms alone.

According to the CDC website: “The diagnosis of ehrlichiosis must be made based on clinical signs and symptoms, and can later be confirmed using specialized confirmatory laboratory tests. Treatment should never be delayed pending the receipt of laboratory test results, or be withheld on the basis of an initial negative laboratory result.”

The CDC goes on to say: “Doxycycline is the first line treatment for adults and children of all ages and should be initiated immediately whenever ehrlichiosis is suspected.” (10)

Patients who are treated early may recover quickly on outpatient medication, while those who experience a more severe illness may require intravenous antibiotics, prolonged hospitalization or intensive care.

“© [October 10,2018] [https://drjaydavidson.com/mold-in-the-home/?inf_contact_key=bcb84d711f60d57a7d1c96dfe3f12451ae791a1d2419e622fbda3ee5db9bca9e] This content is distributed and reproduced with the permission of DrJayDavidson.com”

Mold in the Home Dr. Jay Davidson
  • Managing mold has been a long-standing concern for humanity.
  • The stresses of contemporary life, including chemical toxicity, digital toxicity, and emotional stress, contribute to and exacerbate mold’s harmful effects on human life and health.
  • Mold in the home increases the burden of disease.
  • Mold illness is called “mycotoxicosis.”
  • Mold illness harms the body’s immune system, nervous system, and respiratory system, and irritates and inflames the body as a whole.
  • Mycotoxicosis has many and varied symptoms and adverse effects on the body.
  • Mold spores are found everywhere in indoor and outdoor environments.
  • The age of a house does not determine it’s susceptibility to mold invasion and damage.
  • Mold and moisture can be controlled and prevented using some helpful tips and recommendations from the CDC and EPA.
  • Tens of thousands of mold types and species exist in homes and buildings.
  • A home walk-through inspection, with an eye on key problem areas, helps pinpoint sources of mold issues in a home.
  • Eliminate mold and prevent it from returning with Dr. Jay’s money-saving tips and need-to-know cautions.
  • Employ Dr. Jay’s At-Home Program or 1:1 Coaching for supplements and protocols that eliminate mold and its effects from the body.

MOLD: Home Invasion by an Uninvited and Unwelcome Guest

Humans and mold have always had a tenuous living arrangement. At times, mold has willingly obliged our efforts to make beer, wine, and cheese from grains, fruit, and milk, as depicted in ancient Egyptian art.

At other times, mold has invaded and imposed upon us, often with dire consequences. Mold was to blame for destroying the entirety of Ireland’s potato crop, resulting in the Great Famine of 1845-1849. Rightfully dubbed the Great Hunger, it left over one million people dead of starvation.

Mold’s harmful effects on human health and well-being are well-documented. Inspection, evaluation, and remediation of mold is an age-old and enduring need. A home mold management protocol, or “cleansing of defiling mold,” is outlined in the Book of Leviticus, from the Old Testament of the Christian Bible. The Bible even recommends that when mold in a home is persistent and continues to spread, the structure must be torn down!

That Was Then; This Is Now

So why must we have a conversation about mold in the present day? One would think with all our sanitizers, fungicides, pre-treatments, and technologies, that mold would be a non-issue in the modern age. Still, mold continues to be a challenging issue, one that is highly exacerbated by the stresses of contemporary living. Certain stresses add a heavy load to the body’s toxic burden, including:

• Chemical toxicity. Thousands upon thousands of chemicals have been created, a very high percentage of which have never been individually tested for safety, and most definitely have not been tested for safety in combination with other chemicals.

• Digital toxicity from electromagnetic fields (EMFs) and electromagnetic radiation (EMR). Both ionizing and non-ionizing radiation are known to produce undesirable biological effects.1 WiFi signals, in particular, are known to exacerbate mold growth and cause the biological mycotoxins released by mold to be more plentiful, potent, and pathogenic.

• Emotional stress is an epidemic in today’s society. Demands and expectations required and put on individuals in our contemporary culture overtax our emotional and physical tolerance.

In the 1990s the Harvard School of Public Health, the World Bank, and the World Health Organization (WHO) coined the term “burden of disease,” which defines loss of health and death due to injuries, diseases, and risk factors.  Sadly, mold in the home increases the burden of disease.2

So, think about it. The mold in your home that was hurriedly wiped off or painted and caulked over, maybe not by you, but by the previous owners, could contribute to illness and death for you and your family. Furthermore, this hidden, health-destroying mold danger is present in buildings where you work, worship, shop, or go to school as well.

Mold in the Home Dr. Jay Davidson

Every Breath You Take

Mold illness, also known as “mold mycotoxicosis,” has harmful effects on the immune system, the central and peripheral nervous systems, and the respiratory organs including the lungs, sinuses, and throat. It’s associated with an across-the-board inflammatory response and generalized irritation to many organs and systems.3 Mycotoxicosis can occur when molds are inhaled, ingested, or come in contact with the skin.

Mold illness has a variety of symptoms including, but not limited to:

  • Fatigue, low energy, weakness, and lack of motivation
  • Headaches, dizziness, and lightheadedness
  • Poor memory, lack of concentration, and difficulty focusing
  • Brain fog, mood swings, and disorientation
  • Morning stiffness, joint pains, and muscle cramps
  • Skin tingling, numbness, irritation, rashes, and unusual sensations
  • Shortness of breath
  • Allergies, sinus congestion, and nosebleeds
  • Coughing, wheezing, and sore throat
  • Increased thirst and urinary frequency
  • Red eyes, blurred vision, and seeing halos around lights
  • Light sensitivity
  • Bloating, nausea, and abdominal discomfort
  • Static shocks

Armed and Dangerous

Toxic byproducts, known as mycotoxins, are produced by many species of mold.4 Over 200 types of mycotoxin have been identified, and many more have yet to be cataloged through ongoing research.

Mold mycotoxins can cause disease and death in humans and animals.5 They range from mild to moderately irritating issues like athlete’s foot to critical and deadly cases such as invasive aspergillosis. The symptoms of mycotoxicity depend on:

  • Type of mycotoxin
  • Duration and amount of exposure
  • Age, sex, and health status of the person exposed
  • Combined effects including genetics, dietary status, and interactions with other toxic assaults

Nutrient deficiency, infectious disease status, alcohol and substance abuse, caloric deprivation, and exposure to EMFs can increase the severity of mycotoxin poisoning. Additionally, mycotoxicoses can exacerbate and enhance the effect of malnutrition and microbial diseases like Lyme and related co-infections. Furthermore, they can combine synergistically with other toxins to overburden the body’s toxic load.

There are many well-recognized types of mold in homes and buildings. A few of the most common are:

  • Penicillium is often responsible for food spoilage. Some species of this blue/green/yellow mold produce mycotoxins.
  • Cladosporium. Many of the over 500 species of Cladosporium appear as green, black, or brown spots. Allergic reactions to this mold are common in sensitive people.6
  • Aspergillus can manifest illness ranging from allergic reaction to severe invasive infection in immunocompromised individuals.7 Some of the over 200 identified Aspergillus species produce mycotoxins. Aspergillus flavus secretes a potent poisonous carcinogen called aflatoxin.8
  • Alternaria is well-known for being allergenic. It’s plentiful in outdoor environments from early spring to late fall.
  • Stachybotrys is the toxic black mold implicated in many health issues, including allergic reactions and mycotoxicoses.

Here, There, and Everywhere

No matter how old or new house is, it can have a mold problem. That’s because mold spores inhabit both indoor and outdoor environments, and their source is not age dependent.

Mold gets in the home through open doorways, windows, vents, and heating and cooling units. It also hitches a ride into the house on shoes, clothing, bags, backpacks, and pets. You can also bring mold into your home with clothing and furnishings obtained second-hand or from thrift shops.

The Center for Disease Control (CDC) recommends these measures to control mold:9

  • Control humidity levels.
  • Promptly fix leaky roofs, windows, and pipes.
  • Thoroughly clean and dry after leaks or flooding.
  • Ventilate shower, laundry, and cooking areas to outside the home.
  • Make sure interior and exterior vents are clean and unobstructed.

Recommendations and tips for moisture and mold prevention include:10

  • Maintain low indoor humidity levels of 30-50%.
  • Ensure adequate ventilation and airflow.
  • Use powerful exhaust fans and leave them running for up to an hour after cooking or showers.
  • Fix leaks without delay.
  • Clean and dry wet places quickly and thoroughly (within 24-48 hours) after leaks or flooding.
  • Run dehumidifiers in damp areas.
  • Ensure adequate airflow when hanging wet towels and clothes.
  • Clean bathrooms with mold-killing products.
  • Remove or throw away furnishings and carpet that can’t be adequately dried.
  • Clear gutters and downspouts and drain away from the structure.
  • Make sure the ground outside slopes away from the home.
  • Aim lawn and garden sprinklers away from the house.

Walk This Way

Evaluate mold in your home by conducting a thorough home walk-through. Take your time and inspect every part of your house. Look at places where water flows or could enter the house. Look underneath things. Pull out and look behind them, too. Think back and do your best to recall all previous water incidents.

Mold Inspection Walk-Through Dr. Jay Davidson

Pay attention to these house-wide considerations:

  • Be alert for musty or moldy smells.
  • Look for insulation, wood, and drywall discoloration.
  • Scrutinize windows and window sills for condensation.
  • Areas of high moisture or humidity are at high risk for mold growth.
  • Indoor plants or soil can contain mold spores. Try adding small stones, aquarium gravel, or decorative glass vase fillers, gems, pebbles, mosaic tiles, and nuggets to retard surface growth.
  • Peeling wallpaper is a good indication of mold-promoting moisture.
  • Reverse osmosis holding tanks are dark and moisture-filled.

Basement

  • Inspect for foundation leaks.
  • Look near a sump pump.
  • Floors and walls may have black, green, or brown patches and streaks. Also look for white areas with spots or yellowish-tinted stains.
  • The back side of basement stairs in the lower treads & risers is an often overlooked spot for toxic mold growth.
  • Furnishings, materials & belongings stored in the basement need to be examined–don’t forget to inspect the back and undersides.

Laundry room

  • Washing machines, particularly front-loading washers, tend to develop mold. Wipe down the seal and leave the door open for an hour after each wash.
  • Washer drain hose. Built up scum and crud here is a breeding ground for mold.
  • Humidity in the clothes dryer can lead to mold growth.
  • Drying racks and clotheslines provide attractive surfaces for mold.

Heating and cooling

  • Turn on AC and heating units to check for moldy or musty smells.
  • Mold and other debris collect on heating and cooling ducts. Make sure to check the flanges, too.
  • Inspect areas around air conditioners, and the AC evaporator, blower, and coils.

Kitchen and bathrooms. Look for plumbing leaks around or under:

  • Sinks.
  • Toilets.
  • Showers and bathtubs.
  • Wet towels should be washed immediately or hung out to dry.
  • Shower curtains, tile grout, and areas in and around the shower head and faucet collect mold and mildew.
  • Mold may be lurking on bathing accessories such as shampoo, conditioner, and body wash bottles, and washcloths, loofas, and body scrubbers.

Attics or crawl spaces

  • Roof leaks can leave dampness and discolored insulation or wood.
  • Roof valleys, V-shaped joints where two roofs meet, accumulate mold and debris.
  • Plumbing stacks and dryer & bathroom vents cause condensation issues.

Your home walk-through could leave you overwhelmed and wondering what to do next. You can seek help from professional mold evaluation, removal, and remediation specialists. Research thoroughly the services available in your locality.

Don’t Stop Believin’

There are a wealth of essential tips and supplement protocols in Dr. Jay’s At-Home Lyme Disease Program that can help you mount an offense against mold’s uninvited and unwelcome invasion. To receive one-on-one advice and support in your quest to remove toxic mold from your home and body, apply for the 1:1 Coaching Program.

So, while your living arrangement with mold may always be contentious, with a bit of help, some steadfast determination, and perseverance you can cleanse mold from your body and turn things around in your home.

Keep in mind that although your battle with mold may seem quite personal, it’s really just part of the human condition. Humanity has been dealing with the unwelcome intrusion of mold since day one.

  1. Li, De-Kun et al. “Exposure to Magnetic Field Non-Ionizing Radiation and the Risk of Miscarriage: A Prospective Cohort Study.” Scientific Reports, Vol 7, 13 Dec 2017. Web
  2. WHO staff. “Environmental Burden of Disease Associated with Inadequate Housing.” World Health Organization. No date. Web
  3. Campbell, Andrew, et al. “Mold and Mycotoxins: Effects on the Neurological and Immune Systems in Humans.” Advances in Applied Microbiology, Vol. 55, 2004. Web
  4. Bennett, J. W., and M. Klich. “Mycotoxins.” Clinical Microbiology Reviews, Vol. 16, No. 3 July 2003. Web
  5. Fink-Gremmels, J., “Mycotoxins: Their Implications for Human and Animal Health.” The Veterinary Quarterly, Vol. 21, No. 4, Oct 1996. Web
  6. Bensch, K. et al. “The Genus Cladosporium.” Studies in Mycology, Vol. 72, June 2012. Web
  7. Sugui, Janyce A. et al. “Aspergillus Fumigatus and Related Species.” Cold Spring Harbor Perspectives in Medicine, Vol. 5, No. 2, Feb 2015. Web
  8. Klich, M.A., “Aspergillus flavus: The Major Producer of Aflatoxin.” Molecular Plant Pathology, Vol. 8, No. 6, Nov 2007. Web
  9. CDC staff. “You Can Control Mold.” Centers for Disease Control and Prevention. No date. Web
  10. EPA staff. “A Brief Guide to Mold, Moisture, and Your Home.” Environmental Protection Agency, 402-K-02-003, Sept 2010. Web

__________________

For More:  https://madisonarealymesupportgroup.com/2018/10/14/got-mold/

https://madisonarealymesupportgroup.com/2018/05/15/watch-the-documentary-moldy-for-free-for-a-limited-time/

https://madisonarealymesupportgroup.com/2017/11/08/house-making-you-sick-mold-lyme-msids/

Got Mold?

Upcoming Toxic Mold Summit FREE and online.  From Jan. 28-Feb 3, 2019.

Register here:  https://toxicmoldproject.com/?idev_id=10581&idev_username=betterhealthguy&utm_source=10581

Also

Dr. Neil Nathan’s New Book:  Toxic:  Heal Your Body from Mold Toxicity, Lyme Disease, Multiple Chemical Sensitivities, and Chronic Environmental Illness.

Toxic book

_________________________________________________________________________________________________

Podcast:  Life After Mold with Dr. Lauren Tessier

Lauren Tessier, ND is a Naturopathic Physician licensed in the state of Vermont. She received her Bachelors in Premedical Sciences and Health Psychology from Massachusetts College of Pharmacy in Boston and later became a Naturopathic Physician at Bastyr University in Kenmore, Washington.

Her practice, Life After Mold, uses a patient-centered approach to help recover those that are suffering from mold-related illness.  She combines naturopathic, functional, and integrative medicine to address the entire person.  She is a Shoemaker Certified Physician specializing in the treatment of Chronic Inflammatory Response Syndrome (CIRS) which results from exposure to water-damaged buildings.

In 2011, Hurricane Irene created an unimaginable flood in Waterbury, Vermont, and she was unprepared for what she would see next in her practice.  Patients were ill with unexplained rashes, allergies that did not respond to treatment, fatigue, breathing difficulties, neurological complaints, headaches, nausea, and immune system dysfunction.  When her normal approaches no longer worked for these patients, she dove deep into mold-related illness.

Her practice is dedicated to helping those suffering with mold, biotoxin, and mycotoxin associated illness resulting from water-damaged buildings. As time passed, she came to the belief that the environment plays a role in all chronic illness.  Environmental illness includes mold, heavy metals, glyphosate exposure, chronic infections such as Lyme disease, Multiple Chemical Sensitivity, and Mast Cell Activation Syndrome.  Dr. Tessier is an Executive Board Member of the International Society for Environmentally Acquired Illness (ISEAI) which aims to advance medical knowledge surrounding environmentally acquired illness.

Key Takeaways

  • What are some of the environmental factors that may predispose an environment to water-damage and the potential for mold illness?
  • What are some of the illness-creating substances that are found in a water-damaged building?
  • What are common symptoms of CIRS?
  • Are there basic screening tests that can be performed of an environment before investing in an IEP?
  • How important are the HLA haplotypes in CIRS?
  • Is there clinical value in urinary mycotoxin testing?
  • Can molds encountered in a water-damaged building lead to colonization within the body?
  • When considering binders, what is absorption vs. adsorbtion?
  • Why is bile flow important and how might it be supported?
  • What options might help reducing inflammation in those with CIRS?
  • Are there downsides of exogenous glutathione supplementation?
  • How important is eradicating MARCoNS in CIRS?
  • How might VIP and Synapsin be helpful in those with CIRS?
  • What triggers Mast Cell Activation Syndrome (MCAS) and how might it be addressed?
  • When someone feels significantly worse, what rescue items might help to move through a detox or Herxheimer reaction?
  • Is there a role for limbic system retraining in CIRS?

Connect:  http://lifeaftermold.com

In the same vein, here’s another Podcast titled:

Create Your Healthy Home with May Dooley, MS, MA, CMC

In this episode, you will learn about Bau Biologie, or Building Biology, and how to evaluate and improve the health of the external environment in order to improve overall health.

May Dooley, MS, MA, CMC (Council-certified Microbial Consultant) is a former middle school science teacher who loves to educate and empower people with information to improve their environment – and thus, their lives.  She has been an environmental consultant for more than 24 years helping people make their home environment healthier.

She leads her clients through the basic steps to assess and create a healthy home which includes air quality, water quality, and reduced exposure to other stressors that may impact health such as electromagnetic fields.  Her inspections are interactive, and her clients learn how to measure EMFs, reduce body voltage in their bed, use a laser particle counter to evaluate their vacuum cleaner, and to take samples to explore for mold.  She even brings along her microscope and looks at the samples in your home.  Once she has evaluated an environment using the principles of Bau Biologie, she provides an easy-to-understand series of steps to improve the environment.

Key Takeaways

  • Why might culture plate air sampling be a better option than spore trap testing?
  • What are the pros and cons of the ERMI?
  • What is the CAP ERMI?
  • What role do microbial VOCs play in the health of an environment?
  • How often can mold issues be remediated?
  • How is a microscope helpful in exploring the potential for mold?
  • When moving to a new environment, what testing should be done to validate the environment is safe?
  • What belongings can be brought from a moldy environment to a new environment?
  • What can be used to address small amounts of visible mold?
  • What vacuum cleaners are ideal?
  • What are the 5 different types of EMFs and their sources?
  • What is body voltage and how is it measured?
  • What is grounding and how should it be done?
  • Why should the bed have no metal materials?
  • What light bulbs might be best?

Connect: http://createyourhealthyhome.com
http://moldcontrolonabudget.com

Disclaimer

The content of this show is for informational purposes only and is not intended to diagnose, treat, or cure any illness or medical condition. Nothing in today’s discussion is meant to serve as medical advice or as information to facilitate self-treatment. As always, please discuss any potential health-related decisions with your own personal medical authority.

________________

For more:  https://madisonarealymesupportgroup.com/2018/05/15/watch-the-documentary-moldy-for-free-for-a-limited-time/

https://madisonarealymesupportgroup.com/2018/03/13/are-mold-mycotoxins-compromising-your-recovery/

https://madisonarealymesupportgroup.com/2017/11/08/house-making-you-sick-mold-lyme-msids/

https://madisonarealymesupportgroup.com/2018/02/24/top-3-lyme-detox-myths-busted-dr-rawls/

 

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/23412818?

Direct Diagnostic Tests for Lyme Disease

Carl Tuttle
Hudson, NH
OCT 13, 2018 —

Latest message to the TBD Working Group:
———- Original Message ———-
From: Carl Tuttle <runagain@comcast.net>
To: jaucott2@jhmi.edu, tickbornedisease@hhs.gov
Cc:
Date: October 12, 2018 at 1:48 PM

Subject: Re: News Release: Dr. Sin Hang Lee Accuses CDC of Resorting to Politically Motivated False Science to Cover Up Its Failure to Promote More Exacting Test for Lyme Disease

To the Tick Borne Disease Working Group,

Please see the viewpoint below recently published in Clinical Infectious Diseases regarding direct detection tests for Lyme disease.

I have purposely highlighted coauthor Martin E Schriefer of the Centers for Disease Control because he was one of the CDC officials working directly with Dr. Sin Lee of Milford Molecular Diagnostics regarding “direct detection” of Lyme disease.

All communication from the CDC stopped with Dr. Lee with absolutely no explanation whatsoever prompting the current lawsuit.
And now we see Schriefer’s name on this publication pushing for DNA tests?

It’s time to fire the CDC and take control of this runaway plague as all the evidence indicates deliberate mishandling of a disease that is destroying lives, ending careers while leaving its victims in financial ruin.

Carl Tuttle
Lyme Endemic Hudson, NH

CORRECTED PROOF

Direct Diagnostic Tests for Lyme Disease

Steven E Schutzer, Barbara A Body, Jeff Boyle, Bernard M Branson, Raymond J Dattwyler, Erol Fikrig, Noel J Gerald, Maria Gomes-Solecki, Martin Kintrup, Michel Ledizet, Andrew E Levin, Michael Lewinski, Lance A Liotta, Adriana Marques, Paul S Mead, Emmanuel F Mongodin, Segaran Pillai, Prasad Rao, William H Robinson, Kristian M Roth, MARTIN E SCHRIEFER, Thomas Slezak, Jessica L Snyder, Allen C Steere, Jan Witkowski,Susan J Wong, John A Branda

Clinical Infectious Diseases, ciy614, https://doi.org/10.1093/cid/ciy614

Published: 11 October 2018

Abstract
Borrelia burgdorferi was discovered to be the cause of Lyme disease in 1983, leading to seroassays. The 1994 serodiagnostic testing guidelines predated a full understanding of key B. burgdorferi antigens and have a number of shortcomings. These serologic tests cannot distinguish active infection, past infection, or reinfection. Reliable direct-detection methods for active B. burgdorferi infection have been lacking in the past but are needed and appear achievable. New approaches have effectively been applied to other emerging infections and show promise in direct detection of B. burgdorferi infections.

______________________________

THE FOLLOWING EMAIL WAS PREVIOUSLY SENT TO THE TBD WORKING GROUP AND POSTED AS AN UPDATE HERE: https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/23321574

Subject: Re: News Release: Dr. Sin Hang Lee Accuses CDC of Resorting to Politically Motivated False Science to Cover Up Its Failure to Promote More Exacting Test for Lyme Disease

On September 25, 2018 at 11:11 AM Carl Tuttle <runagain@comcast.net> wrote:

To the Tick-Borne Disease Working Group,

Before you read the following press release I would like to point out that Patient #45 from Table 2 of the attached CDC document titled, “Reply to Response to Motion to Dismiss” (page 26) had a bulls-eye rash and a single positive Western blot Band 41 which as you know is the flagellar antigen of Borrelia burgdorferi.

Patient #45 has a case of early Lyme confirmed by the bulls-eye rash but hadn’t yet produced a full set of antibodies to the infection. Dr. Lee’s 16S rRNA gene sequencing was able to accurately detect early infection before antibody production.

The CDC claims the following:

“ with respect to pretreatment patients, he (Dr. Sin Hang Lee) reported B. burgdorferi in a patient whose antibody testing failed to indicate the presence of the disease at all (patient 45). Attachment I at 4287 and 4292. Therefore, Dr. Lee’s tests were not accurate.”

For the record, you will find the following statement from the CDC website:

Diagnosis, Testing, and Treatment

https://www.cdc.gov/lyme/faq/index.html

Excerpt:
As with serologic tests for other infectious diseases, the accuracy of the test depends upon the stage of disease. During the first few weeks of infection, such as when a patient has an erythema migrans rash, the test is expected to be negative.

______________________________________

The CDC is responsible for the current Lyme disease crisis where patients cannot obtain a timely diagnosis through accurate early detection.

This perpetuated outdated dogma of using a restricted pattern of antibody tests for disease definition is now on record disclosing the hidden agenda of the bureaucrats in charge of the Lyme disease policy.

MILFORD MOLECULAR DIAGNOSTICS

2044 Bridgeport Avenue
Milford, CT 06460
http://www.dnalymetest.com

September 25, 2018

Media Contact:
Kevin Moore
203-788-8497

FOR IMMEDIATE RELEASE

In Unprecedented CDC lawsuit, Dr. Sin Hang Lee Accuses CDC of Resorting to Politically Motivated False Science to Cover Up Its Failure to Promote More Exacting Test for Lyme Disease

Milford, Conn. – Dr. Sin Hang Lee, the Connecticut based pathologist who, in May, filed an unprecedented $57.1 million Lyme disease related lawsuit against theUnited States Centers for Disease Control and Prevention (CDC),charged the CDC in a legal filing* this week of employing false, pseudo-scientific theories in order to justify its own anti-consumer actions aimed at perpetuating Lyme disease testing by a flawed technology previously endorsed by the CDC. It is also believed that certain current and former CDC representatives receive personal financial gains (royalties) as a result of their having worked on the approval and promotion/CDC endorsement of a Lyme disease serology test.

According to Dr. Lee, the truth behind the CDC’s inexplicable retreat from supporting a cutting-edge test capable of diagnosing Lyme disease infections with 100% accuracy, came to the surface in the CDC’s lawsuit-related recent filing in theU. S. Court of Federal Claims. For the purpose of suppressing direct detection tests to diagnose early Lyme disease infections, the CDC’s lawyers wrote,

“with respect to pretreatment patients, he (Dr. Sin Hang Lee) reported B. burgdorferi in a patient whose antibody testing failed to indicate the presence of the disease at all (patient 45). Attachment I at 4287 and 4292. Therefore, Dr. Lee’s tests were not accurate.”

Dr. Lee informed the Court through his legal counsel,

“Using Lyme disease serology test results to overrule 16S ribosomal RNA gene sequencing diagnosis of Lyme borreliosis is to practice Lysenkoism in disguise.” It is serious when the CDC allows its policies to be made on the basis of bogus science, said Dr. Lee.

Dr. Sin Hang Lee, a Connecticut pathologist and the plaintiff in the $57.1 million lawsuit against the CDC, said Lyme disease is actually a chronic tick-borne borrelia infection or its sequelae because this bacterial infection has not been diagnosed correctly at the early stage for timely appropriate treatment.

The world’s scientific literature of medicine all agrees that 16S rRNA DNA sequencing of bacterial genes in patient specimens is a tool to reach irrefutable diagnosis of bacterial infections, including those due to Borrelia, even if antibodies to the bacteria in the patient are not measurable.

When a government authority, like the CDC, insists upon using a negative antibody testing result to overrule the 16S rRNA gene sequencing diagnosis of Borrelia burgdorferi infection in official federal court documents, this is concrete evidence that the CDC has resorted to Lysenkoism to perpetuate Lyme disease in the United States, said Dr. Lee through his lawyer*.

Lysenkoism once prevailed in the Soviet Union under Stalin when bogus science was used to suppress true biological and medical sciences and to punish the scientists and medical doctors who did not follow the Party Line. Since the CDC has now, for the first time, officially narrowed the case definition of Lyme disease in a Federal Court case as an illness to be diagnosed by testing the antibodies against a particular strain of Borrelia burgdorferi to the exclusion of all other direct detection diagnostics, including Sanger sequencing, this Party Line must be challenged by evidence-based science in the public eye as well as in Court, said Dr. Lee.

* See document, called Sur-Reply filed on September 20, 2018 at the U.S. Federal Court of Claims in response to the CDC statements previously submitted to the Court on August 27, 2018.
###
Attachments:
1. Lee – Reply to Response to Motion to Dismiss
2. Lee – Sur-Reply re Motion to Dismiss 2018-09-20

Carl Tuttle
Lyme Endemic Hudson, NH

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For more:  

https://madisonarealymesupportgroup.com/2018/10/12/direct-diagnostic-tests-for-lyme-the-closest-thing-to-an-apology-you-are-ever-going-to-get/

Key quote: “These serologic tests cannot distinguish active infection, past infection, or reinfection.”

In plain English, the CDC’s “FDA approved” two-tiered tests don’t show squat.

Direct detection is nothing new. Dr. Sin Hang Lee sued the CDC over their suppression of HIS direct detection test. https://madisonarealymesupportgroup.com/2018/08/15/milford-pathologist-fires-broadside-at-cdc-motion-to-discuss/
Another great article showing how they’ve worked tirelessly to suppress direct detection tests: https://madisonarealymesupportgroup.com/2018/04/03/cdc-deliberately-avoids-direct-detection-testing-methods-for-ld/

https://madisonarealymesupportgroup.com/2018/10/12/paving-the-way-for-better-lyme-diagnostic-tests/  (This article does a great job explaining the tests)

In the comment section I explain how small labs like IGeneX have been poisonously smeared by the CDC.  I actually attended a public meeting at the WI capital where a pediatric doctor quoted right off the CDC website and called the IgeneX Lyme test, “Home-brewed.”

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6315a4.htm
“Often these are laboratory-developed tests (also known as “home brew” tests) that are manufactured and used within a single laboratory and have not been cleared or approved by FDA. 

Patients, the doctors who dare treat them, and these smaller labs specializing in bacteriology and virology have been quaking in their boots for decades due to the antics of the CDC.

The CDC is a bully, plain & simple.

As promised, here is the followup from earlier today on the “new” direct testing for Lyme:  https://madisonarealymesupportgroup.com/2018/10/12/direct-diagnostic-tests-for-lyme-the-closest-thing-to-an-apology-you-are-ever-going-to-get/

https://www.lymedisease.org/better-lyme-diagnostic-tests/

LYME SCI: Paving the way for better Lyme diagnostic tests
better-Lyme-diagnostics-300x300

By Lonnie Marcum

For decades, one of the biggest barriers to good medical care for Lyme disease has been a dearth of effective and accurate Lyme diagnostic tests.

Through the years, the CDC has continued to recommend an inadequate test that was designed in the 1980s.

All along, the CDC, the IDSA, and others in the medical mainstream have insisted that what’s called “two-tier Lyme serology” is the appropriate way to determine who does and does not have the illness.

Now, a group of researchers from Rutgers, Yale, Harvard, FDA, NIH, CDC and other institutions have published an article in Clinical Infectious Diseases acknowledging the failings of the current IDSA diagnostic guidelines recommended at the Dearborn Conference in 1994.

The scientists reached the following conclusion:

“The 1994 serodiagnostic testing guidelines predated a full understanding of key B. burgdorferi antigens and have a number of shortcomings.”

“A number of shortcomings? That’s putting it mildly,” says LymeDisese.org’s Founder and President Phyllis Mervine. “Since the first Lyme case was identified in 1977, the Lyme community has been crying for an accurate test and better treatment. The powers-that-be kept telling us how benign Lyme is, how great the Lyme diagnostic tests are and how easily the disease can be cured.”

Luckily, better tests are finally becoming available.

New Lyme diagnostic tests detect multiple species

As the CDC has not promoted any improvements in testing since 1994, many private laboratories have taken on the burden of research and development themselves.

One such private lab, IGeneX, has developed two new immunoblot tests capable of detecting multiple species of Borrelia (see below). The “Lyme ImmunoBlot” test is approved for use in all states including New York. The “TBRF ImmunoBlot” is currently undergoing validation review by New York State, Department of Health and thus is available to all US residents outside of New York.

IGeneX ImmunoBlots Detect:

Lyme ImmunoBlot                TBRF ImmunoBlot
B. burgdorferi B31                   B. coriaceae
B. burgdorferi 297                    B. hermsii
B. afzelii                                   B. miyamotoi
B. Californiensis                      B. parkerii
B. garinii                                  B. turcica
B. mayonii                               B. turcatae
B. spielmanii                           B. texasensis
B. valaisiana

What is the CDC-recommended test for Lyme disease?

The currently recommended Lyme diagnostic test was originally designed for surveillance (to track the spread) of a single species of bacteria—later named Borrelia burgdorferi B31—that was first detected in and around Lyme, Connecticut. That test was never intended to diagnose Borreliosis (infection caused by Borrelia) in other parts of the US or on other continents.

Today, we know there are over 300 strains of Borrelia worldwide. They are divided into two broad categories: Borrelia burgdorferi sensu lato (which causes Lyme disease), and Tick-borne Relapsing Fever Borrelia (which causes Lyme-like illness or TBRF). Let’s call these types A and B. The current Lyme test detects only a fraction of type A cases and gives anyone with type B a negative result.

As Dr. Jyotsna Shah, CEO of IGeneX explains,

“With the increase of international travel, people may get infected in various parts of the US or abroad. Thus, it is important to have a test that can detect the infection no matter where it was acquired.”

Sensitivity vs. Specificity

Currently, the CDC recommends a two-step indirect method for Lyme testing, designed to detect the body’s immune response (antibodies) to infection. The first step uses an Indirect Immunofluorescent assay or an automated ELISA. These are fast and relatively inexpensive. Only if the first step is positive will the second step be performed. The second test, a Western Blot, is more inclusive but also more complex and subject to human error.

Ideally, to design an accurate 2-tier Lyme test, the first step (ELISA) would be very sensitive (i.e. no false-negatives, but some false-positives). The second step (Western blot) used for confirmation, would be very specific (i.e. no false-positives).

In a perfect world, all tests would be 100% sensitive and 100% specific, meaning not a single person with infection would go undetected and all uninfected persons would test negative. Think of HIV, where you want to be 100% certain that you do not misdiagnose a single case.

The whole topic of “sensitivity” and “specificity” is one we hear a lot about in relation to testing, but it’s one that many of us do not fully understand. For simplicity sake, I’ll use the example of an airport metal detector to explain the two-tier testing process.

First step should detect anything questionable

Like a metal detector, you want the first step to be highly sensitive, capable of detecting anything that is remotely questionable. Thus, even metal belt buckles and key chains will set off an alarm—even though they aren’t what the security agents are looking for.

If the detector senses anything suspect, the passenger is then subjected to a second, highly specific screening that involves a hand-held wand and closer examination to determine exactly what the object is.

The idea is that it’s better to take a second look at something that may turn out to be harmless—like a watch or a metal pen—then to let somebody board the airplane with a weapon.

Likewise, the ELISA (the first step) would ideally detect all suspected cases of Lyme. Unfortunately, with the standard test for Lyme, almost 30% of the people with Lyme disease and all the people with TBRF will test negative on the first step, and never be given the second confirmatory Western blot that is far more specific.

This is akin to setting airport metal detectors so that they only find big weapons, like machine guns, and anything smaller than that will sail through without notice.

How secure would you be with such a system?

Why Lyme disease is so difficult to diagnose

  1. The majority of people do not realize they were bitten by a tick, and do not see the “bull’s-eye” rash that is typical of Lyme;
  2. It takes 2-8 weeks (or longer) for the immune system to produce the markers (antibodies) necessary for detection on standard blood testing,
  3. The bacteria can form biofilms and prefer to live in deep tissues rather than the blood stream where blood tests are most effective at detecting antibodies;
  4. Borrelia have special mechanisms called “sleeper cells” that allow them to hide from the immune system, thus further suppressing the production of antibodies;
  5. Patients with co-infections often have suppressed immune systems and many never develop antibodies to Borrelia.
  6. Seronegativity could also be due to antibody being bound in immune complexs and therefore not available for binding to antigens on the immunoblot strip.
  7. The patient may be infected with a strain of Borrelia that is not detected by standard tests.

Adding to the difficulty of diagnosis, Lyme disease is known as a “great imitator,” because it can infect every system of the body causing a myriad of symptoms that mimic illness such as Arthritis, ALS, Chronic Fatigue Syndrome (CFS), Fibromyalgia, Lupus, Multiple Sclerosis (MS) or Myalgic Encephalomyelitis (ME).

New and improved immunoblots

The primary difference between the CDC-recommended two-tier test and IGeneX’s new ImmunoBlots is the sensitivity. Where the CDC test was designed to be highly exclusive (only detects one species of Borrelia, B31), the ImmunoBlots are designed to be highly inclusive (sensitive to multiple species of Borrelia).

For many years IGeneX was able to increase the sensitivity of its Western Blot by adding an additional species, Bb 297). Today, the company has further increased the sensitivity of its new ImmunoBlots by sourcing antigens from multiple species of Borrelia from the US and Europe (see chart).

“The Lyme ImmunoBlot is intentionally more inclusive for Borrelia burgdorferi sensu lato than the currently available Western blots because we now know that other species such as B. mayonii, B. californiensis and B. spielmanii all cause disease in the US,” said Dr. Shah.

High Accuracy Across the Disease Spectrum

The accuracy of the Lyme ImmunoBlot and TBRF ImmunoBlot have been established by exhaustive testing. The sensitivity with well-characterized samples have been shown to be greater than 90%, whereas the two-tier testing recommended by CDC has a sensitivity of about 55%.

And this high degree of sensitivity does not come at the cost of specificity. IGeneX has done this by:

  1. Including two bands that are highly specific to the outer surface proteins of Borrelia (see Band 31 OspA and 34 OspB below), and
  2. Eliminating the bands that are non-specific to Borrelia (see Bands 18, 28, 30, 45, 58, 66 below)

igenex-chart-1024x1024

Additionally, the ImmunoBlots detect the full spectrum of the disease: early, active and late-stage disease. This high degree of sensitivity does not come at the cost of specificity, with the ImmunoBlots showing 99 and 97% and 95 and 97.5% specificity for Lyme and TBRF IgM and IgG respectively.

Future directions

As FDA, CDC & NIH researchers are finally acknowledging, newer approaches to testing that have been effectively applied to other emerging infectious diseases show promise in the detection of Borrelia infections.

The lead author of the IDSA paper, Steven Schutzer, a physician-scientist at Rutgers New Jersey Medical School states,

”It will not be surprising to see direct tests for Lyme disease join the growing list of FDA-approved direct tests for other bacterial, fungal and viral infections that include Staphylococcus, Streptococcus, Candida, influenza, HIV, herpes and hepatitis, among others.”

The Lyme community has been waiting decades for these improvements and will applaud when these Lyme diagnostic tests become the standard of care for all patients.

LymeSci is written by Lonnie Marcum, a Licensed Physical Therapist and mother of a daughter with Lyme. Follow her on Twitter: @LonnieRhea Email her at: lmarcum@lymedisease.org .

References:
New techniques can detect Lyme disease weeks before current tests:  https://eurekalert.org/pub_releases/2018-10/ru-ntc100818.php

Pilot Study of Immunoblots with Recombinant Borrelia burgdorferi Antigens for Laboratory Diagnosis of Lyme Disease:  https://www.ncbi.nlm.nih.gov/pubmed/30110913

NCBI: Taxonomy Browser, Borrelia:  https://www.ncbi.nlm.nih.gov/Taxonomy/Browser/wwwtax.cgi

_________________

**Comment**

Lyme literate doctors (LLMD’s) trained by the International Lyme and Associated Diseases Society (ILADS) have always preferred labs such as IGeneX due to the very fact they include more bands and are more sensitive.  But, these very doctors have always known Lyme/MSIDS is a clinical diagnosis.

Lazy practitioners, on the other hand, treat this as any other infectious disease and it just can’t be treated that way.  It’s far too complex.

The CDC has undertaken a smear campaign against IgeneX any other lab that has dared to compete with their “FDA approved” tests.  I actually attended a public meeting at the WI capital where a pediatric doctor quoted right off the CDC website and called the IgeneX Lyme test, “Home-brewed.”  https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6315a4.htm

“Often these are laboratory-developed tests (also known as “home brew” tests) that are manufactured and used within a single laboratory and have not been cleared or approved by FDA. Recently, CDC has received inquiries regarding a laboratory-developed test that uses a novel culture method to identify Borrelia burgdorferi, the spirochete that causes Lyme disease. Patient specimens reportedly are incubated using a two-step pre-enrichment process, followed by immunostaining with or without polymerase chain reaction (PCR) analysis. Specimens that test positive by immunostaining or PCR are deemed “culture positive” (2). Published methods and results for this laboratory-developed test have been reviewed by CDC. The review raised serious concerns about false-positive results caused by laboratory contamination and the potential for misdiagnosis (3).  CDC recommends that laboratory tests cleared or approved by FDA be used to aid in the routine diagnosis of Lyme disease. A complete searchable list of such tests is available online (4).”

Then they complete the same rant we’ve all heard 1,000 times about the distinction between “FDA approved” and “CLIA certified” and essentially diss CLIA because it doesn’t address the clinical validity of a specific test.  FDA approval, on the other hand, promises that a test has “adequate analytical and clinical validation and is safe and effective.”

Even though their tests completely suck.

Sigh.

I can only guess what it costs a lab to go through the FDA process.  Meanwhile, the CDC and their ilk spread a smear campaign to every single doctor worldwide about how bad these small, specialty labs are leaving only a handful of quaking doctors who are threatened by state medial boards on a daily basis for treating us, using them.  Let’s just say these small specialty labs have had it rough.  They have fought tooth and nail just to keep their doors open.  FDA approval has been the last thing they have been worried about.

Oh, yes, my friends, the CDC plays dirty and has a lot to answer for.

As lab certifications go, CLIA is one of the toughest, most stringent certifications a lab can undertake.  And, these smaller labs specialize in virology and bacteriology where huge monopolies like Lab Corp and Quest specialize in nothing, yet for decades have profited hugely by giving the CDC garbage can Lyme test that tells you little to squat.  If you test positively on that sucker, you’ve won the lotto.

Countless patients have tested negatively on this insensitive test and have been told they are making up symptoms for attention.  They are offered an anti-depressant and are sent home with something that could kill them.

Yeah, I’m a little ticked off.  Pardon the pun.

dog-tick-closeup-rocky-mountain-spotted-fever

 

 

 

 

 

https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciy614/5126199

Abstract

Borrelia burgdorferi was discovered to be the cause of Lyme disease in 1983, leading to seroassays. The 1994 serodiagnostic testing guidelines predated a full understanding of key B. burgdorferi antigens and have a number of shortcomings. These serologic tests cannot distinguish active infection, past infection, or reinfection. Reliable direct-detection methods for active B. burgdorferi infection have been lacking in the past but are needed and appear achievable. New approaches have effectively been applied to other emerging infections and show promise in direct detection of B. burgdorferi infections.___________________**Comment**

Key quote:  “These serologic tests cannot distinguish active infection, past infection, or reinfection.”

In plain English, these tests don’t show squat.

Yet, my friends, these very useless tests have been used from the beginning to deny treatment to extremely sick people.  “It’s all in your head.  Here’s a anti-depressant.”  “Go, and be well.”  

Lyme patients and the doctors who dare treat them have been shouting this for decades, so the reason for this admission, and it is an admission, is that something’s in the pipeline that they think is going to appease us, and in fact, right after this post, I’m going to post another article that in fact gives the details on this “New direct detection” test.  The only problem is, direct detection is nothing new.  Dr. Sin Hang Lee has even sued the CDC over their suppression of HIS direct detection test.  https://madisonarealymesupportgroup.com/2018/08/15/milford-pathologist-fires-broadside-at-cdc-motion-to-discuss/

Another great article showing how they’ve worked tirelessly to suppress direct detection tests:  https://madisonarealymesupportgroup.com/2018/04/03/cdc-deliberately-avoids-direct-detection-testing-methods-for-ld/

Here’s the thing, though, testing is NOT the end all with Lyme/MSIDS.  Not even THIS new test.  If anyone is expecting the perfect test, to my knowledge none exists due to all the variables at play including but not limited to how long you’ve been infected and what other pathogens are at play.  The best approach at this point is STILL to go to a knowledgable, educated, experienced practitioner who understands this beast clinically and can diagnose and treat CLINICALLY.

 

Nothing about this beast is easy or straight forward.  Frankly, it doesn’t fit into the Western Medicine paradigm and it never will.  My first appointment with a LLMD was 90 minutes.  90 MINUTES!  Prior to that appointment I filled out a veritable encyclopedia’s worth of medical history dating back to infancy!  Since you can contract Lyme and numerous coinfections congenitally, it very well may be the reason for many peoples’ ill health that they’ve coped with for decades thinking it 1,000 different things.  https://madisonarealymesupportgroup.com/2018/06/19/33-years-of-documentation-of-maternal-child-transmission-of-lyme-disease-and-congenital-lyme-borreliosis-a-review/

No, this will never fit into a 10 minute Western Medicine paradigm.