https://www.linkedin.com/pulse/many-100s-subjects-participating-valneva-vla15-lyme-luche-thayer/

Many 100s of Subjects Participating in Valneva VLA15 Lyme Vaccine Trials

Published on December 16, 2018

Jenna Luche-Thayer

 

FRIENDS,

The OspA based LYMErix vaccine was problematic with 1000+ adverse reactions and ongoing severe complications. According to the US government, the LYMErix vaccine had many health risks and was quite ineffective. Nevertheless, the biotech company Valneva appears to be using a similar OspA-based technology for their VLA15 Lyme vaccine.

TO NOTE: On December 3, 2018, the US federal Tick Borne Diseases Working Group stated they would be addressing Lyme vaccine safety concerns in their 2020 Report to Congress. This 2020 Report to Congress coincides with the end of the most experimental and riskier phases of the VLA15 trials.

US GOVERNMENT MESSAGE ON LYMERIX

The Directorate of Technical Support of the Department of Labor’s (USDOL) Occupational Safety and Health Administration’s (OSHA) issues Hazard Information Bulletins in accordance with OSHA instruction CPL 2.65 to provide relevant information regarding unrecognized or misunderstood health hazards. Hazard Information Bulletins are initiated based on information provided by the field staff, studies, reports and concerns expressed by safety and health professionals, employers and the public. Bulletins are developed based on thorough evaluation of available facts in coordination with appropriate parties.

Excerpted from the USDOL/OSHA Hazard Information Bulletin [1] regarding the LYMErix Vaccine:

“Communications with the Vaccine Adverse Events Reporting System Hotline during September 1999 indicated some reports of adverse events relating to LYMErix have been made”

“Lyme disease vaccine does not protect all recipients against infection with B. burgdorferi (Lyme)”

“Consequently, vaccinated persons, as well as the unvaccinated, should continue to practice good prevention and personal protective measures to prevent tick bites, and they should seek medical attention for early diagnosis and treatment of suspected tickborne infections”

“The duration of protection with LYMErix is not known …”

“LYMErix is not recommended for certain groups of people [including] Pregnant Women, Persons with Immunodeficiency and Persons with Musculoskeletal Disease [such as] persons with diseases associated with joint swelling (including rheumatoid arthritis) or diffuse musculoskeletal pain”

Safety and efficacy are unknown for persons with chronic joint or neurological illness related to Lyme disease and for persons with second-or third-degree atrioventricular block.”

In a memorandum for Regional Administrators from former Director Ruth McCully [2], of OSHA’s Directorate of Science, Technology and Medicine,

“Workers should be advised of the signs and symptoms of Lyme disease, as well as the primary and secondary preventive measures for decreasing the risk of Lyme disease transmission, acute illness, and chronic health effects. If recognized early, Lyme disease can be easily treated with antibiotic medication. However, if the disease goes unrecognized and untreated, chronic conditions may ensue, including varying degrees of permanent damage to the joints or the nervous system … “

“… In fact, the majority of infected persons do not recall being bitten by a tick … It is very important that the infection be diagnosed and treated with appropriate antimicrobial medication as early as possible because untreated Lyme disease may result in symptoms that are severe, chronic, and disabling. These disorders include chronic inflammatory arthritis, chronic muscle pain, heart disease, and/or neurological (brain and peripheral nerves) disorders. In addition, Lyme disease in a later stage is more difficult to diagnose, and treatment may be more prolonged and costly.”

VALNEVA VLA15 LYME VACCINE

Valneva, a biotech firm, plans to launch a Lyme vaccine. See studies:

—Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis—ClinicalTrials.gov Identifier: NCT03010228

—Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study—ClinicalTrials.gov Identifier: NCT03769194

In both study phases, the target is to enroll approximately 10 percent or more of subjects that are baseline seropositive for Borrelia burgdorferi sensu latu (Lyme).

Valneva announced in an October 2018 article that the:

“Vaccination with OspA was already proven to work in the 1990s” —Valneva is referring to the LYMErix vaccine.

“The safety profile is expected to be similar to other vaccines using the same technology that have been approved for active immunization in adults and children.”

“European Medicines Agency (EMA) provided positive feedback on the Company’s general development approach for its Lyme disease vaccine candidate, VLA15 [and] is largely aligned with previous discussions with the US Food and Drug Administration (FDA) on the strategy for the VLA15 development”

“It is planned to include both study participants that have previously been exposed to Lyme as well as study participants that have not experienced previous infection.”

“Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. Phase 2 is underway and may include 800 subjects at more than 10 study sites in Lyme endemic areas in the U.S. and Europe.”

QUESTIONS

  1. Has the LYMErix vaccine health risk been disclosed to these Valneva Lyme vaccine study subjects?
  2. How will VLA15 accommodate the health risks particular to children?
  3. Will Valneva provide access to all Lyme treatment options from guidelines that meet international standards to those subjects —including children— who develop Lyme infection from the VLA15 studies? Including the: 10 percent or more persons recruited who are seropositive for Lyme infection?  Persons recruited who are seronegative for Lyme infection?
  4. How will the Tick Borne Diseases Working Group 2020 Report to Congress influence the VLA15 Lyme vaccine safety concerns—particularly those regarding children?
  5. Will the Tick Borne Diseases Working Group 2020 Report to Congress promote VLA15, which is a commercial venture by Valneva?
  6. Does the US federal government —e.g. HHS, CDC, NIH, DOD, or any of their employees— own patents related to VLA15?
  7. Do any members of the Tick Borne Diseases Working Group —and/or its Subcommittees— have conflicts of interests related to VLA15?
  8. Other questions? Other concerns?

Faithfully,

Jenna

Jenna Luché-Thayer. 30+ years working globally on the rights of the marginalized. Former Senior Advisor to the United Nations and the US Government. Director, Ad Hoc Committee for Health Equity in ICD11 Borreliosis Codes. Founder, Global Network on Institutional Discrimination, Inc. —Holding institutions accountable for political and scientific solutions. Email jennaluche@gmail.com

__________________

For more:  https://madisonarealymesupportgroup.com/2018/06/06/valneva-seeking-partner-for-350m-lyme-disease-vaccine-effort-prepping-for-phase-2/

https://madisonarealymesupportgroup.com/2017/01/26/lyme-vaccine-to-be-tested-on-humans/

https://madisonarealymesupportgroup.com/2018/07/10/new-effort-for-lyme-disease-vaccine-draws-early-fire/

https://madisonarealymesupportgroup.com/2018/07/01/lyme-vaccine-fail-safety-ignored/

https://madisonarealymesupportgroup.com/2018/06/07/the-lyme-vaccine-russian-roulette/

https://madisonarealymesupportgroup.com/2018/07/22/why-we-care-so-strongly-about-a-potential-lyme-vaccine/

This vaccine should draw early fire, middle fire, and late fire.  The problems with it are endless.

 

https://globallymealliance.org/gla-counters-idsa-criticisms-of-tick-borne-disease-working-group-report/

scientific advisory board

December 10, 2018

GLA Counters IDSA’s Criticisms of Tick-Borne Disease Working Group Report

GLA’s Chief Scientific Officer Provides Evidence-based Rebuttal of IDSA Letter to Head of HHS and Tick-Borne Disease Working Group Report

by Timothy J. Sellati, Chief Scientific Officer, Global Lyme Alliance

Last month, the Tick-Borne Disease Working Group (TBDWG) published its first report to the U.S. Congress, outlining an integrated, multi-pronged approach to the growing public health challenges posed by tick-borne diseases in the U.S. In response shortly thereafter, the Infectious Diseases Society of America (IDSA) sent a letter to to the Secretary of the U.S. Department of Health and Human Services (HHS) stating that if some key recommendations of the TBDWG are implemented, it “would cause significant harm to patients and public health.”

Below is a rebuttal to IDSA’s unfounded criticisms of the TBDWG, which we find hyperbolic in light of the hundreds of man hours worked on the part of dozens of stakeholders dedicated to collecting, collating, and drafting a roadmap to advance the prevention, diagnosis, and treatment of patients suffering from Lyme and other tick-borne diseases.

IDSA’s letter suggests that there are “significant concerns with the working group’s lack of transparency and minimal opportunities for meaningful public input.”

  • The basis for this concern is unclear given that a substantial effort was made to be inclusive of professionals within the academic research community, physicians at renowned academic institutions and in private practice, as well as members of the general public in the form of patients suffering from Lyme and other tick-borne diseases and their advocates. Through contacts with their colleagues and fellow patients sitting on the TBDWG a free flow of ideas and opinions has passed between various stakeholders not part of the working group as well as those on it. The more likely concern of the IDSA is that it could not control the working group’s deliberations and final report through which it means to ensure consistency with the society’s long-held, and some would argue entrenched, ideas about tick-borne disease. Paramount is IDSA’s long-held view that Lyme disease is easy to diagnose, easy to treat, and only very rarely results in lasting consequences of infection. On the contrary, the overwhelming consensus among tick-borne disease researchers is that Post Treatment Lyme disease Syndrome occurs in 10 to 20% of those who received early treatment.

IDSA’s letter also suggests that if implemented, some recommendations of the TBDWG “would cause significant harm to patients and public health.”

  • Besides IDSA’s having only very limited support in the peer-reviewed scientific and medical literature regarding unsafe alternative treatment options, this hyperbole seems intended to spread fear, especially when one takes into consideration tick-borne disease researchers’ ever-evolving clinical understanding of Lyme disease, as opposed to the IDSA’s obsolete mantra that Lyme is easy to diagnose, easy to treat and only rarely results in lasting consequences of infection.

We urge you to ensure that the federal government response to tick-borne diseases is solidly rooted in the best available scientific evidence.”

  • Any claim that the TBDWG is not solidly rooted in the best available scientific evidence is unfounded. TheTBDWG report draws from the efforts of subject-matter experts from such diverse organizations as Johns Hopkins University School of Medicine; Office of the Secretary, U.S. Department of HHS;Stanford University Lyme Disease Working Group; Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention (CDC); Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases (NIAID); Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of HHS; Population Health Sciences and Health Services Research Center of the Institutional Centers for Clinical and Translational Research, Boston Children’s Hospital; Vector-Borne Disease Laboratory; and Maine Medical Center Research Institute, just to name a few.

IDSA suggests that the makeup of the TBDWG is “skewed to individuals with perspectives that do not align with the overwhelming majority of scientific evidence regarding the diagnosis and treatment of Lyme disease.”

  • Evidently, one organization’s definition of “skewed” is another group’s diverse voices, opinions, and peer-reviewed evidence. Ultimately it does not benefit the scientific and medical research enterprise nor the Lyme and other tick-borne disease patient community to hew to the notion IDSA promulgates, which is that “Lyme disease is easy to diagnose, easy to treat, and only very rarely results in lasting consequences of infection”. Moreover, one could effectively argue that at least a subset of IDSA members hold perspectives about the persistence of Lyme borreliosis despite initial antibiotic treatment and see the desperate need for alternative treatment strategies that “do not align” with current scientific evidence.

While IDSA acknowledges that the CDC case definition for Lyme disease is intended for use as an epidemiological tool, they suggest “it is it is incorrect to promulgate the notion that the components of the surveillance definition should not be used for clinical diagnosis”.

  • However, it is important to note as the CDC itself mentions throughout its webpage that the case definition provided is for purposes of surveillance. Nowhere is it mentioned that the case definition criteria listed should be used for clinical diagnostic purposes alone. The CDC goes on to state that “Surveillance case definitions establish uniform criteria for disease reporting and should not be used as the sole criteria for establishing clinical diagnoses, determining the standard of care necessary for a particular patient, setting guidelines for quality assurance, or providing standards for reimbursement.” Finally, the spurious nature of IDSA’s suggestion that components of the surveillance definition could or should be used for clinical diagnosis is evident in the fact that CDC research has confirmed that annual clinical case numbers for Lyme disease are approximately 10-fold higher than the number reported by the CDC. This upward revision of annual Lyme disease cases suggests that considerably more early Lyme diagnoses are being missed than are the result of inaccurate, ultimately non-Lyme, diagnoses being made.

IDSA acknowledges that “some patients who are successfully treated for Lyme disease continue to suffer from persistent symptoms after treatment”.

  • This statement is illogical, however, because a patient who continues to suffer from symptoms caused by infection cannot or should not be classified as successfully treated.

IDSA states that “There is clear, widely accepted scientific evidence indicating that a 10-28-day course of antibiotics, depending on the stage of Lyme disease, will kill the Lyme disease bacterium in humans in all but the rarest of cases”.

  • Unfortunately, IDSA refuses to acknowledge that there also is clear, widely accepted and compelling scientific evidence indicating that 10 to 20% of patients receiving a 10-28-day course of antibiotics progress to Post-Treatment Lyme Disease Syndrome, which has a clear clinical definition, or the more broadly clinically-defined state of chronic Lyme disease. If one considers the number of CDC-reportable cases for 2016 of 364,290 (based on surveillance case reporting to CDC multiplied by a 10-fold factor to account for estimated underreporting) then 36,429 to 72,858 patients annually progressing to PTLDS/chronic Lyme disease cannot reasonably be considered a rarity.

IDSA supports more research to improve diagnostic tools for Lyme disease and they correctly state that it is essential that clinical education is rooted in the best currently available evidence.

  • Yet it is unclear that medical school educators are explaining to students that the best currently available evidence suggests that a large percentage of patients suffer persistent symptomatology as a result of misdiagnosis of early Lyme disease due to deficiencies in the current two-tier test. It is also unknown whether students are instructed in the atypical size, shape and coloration of the erythema migrans (EM) rash, rather than the classic “bull’s-eye” rash, that can be observed in some, but not all Lyme patients. In fact, despite IDSA’s claims, according to the CDC only 70 to 80% of patients with Lyme disease reported to its surveillance system the presence of an EM rash.

IDSA supports increased federal funding for responses to tick-borne diseases and correctly notes that higher level funding should not come at the expense of funding for other diseases, including HIV. The IDSA letter goes on to state that “Pitting one disease against another, as suggested in the draft report, is counterproductive and costly.”

  • While everyone can agree with the former statement, the latter is a mischaracterization of the content and intention of the TBDWG report. Suggesting that the level of funding for Lyme and other tick-borne diseases should be commensurate with the case incidence rates is not pitting one infectious disease against another; it is, rather, a fair-minded plea for equitable distribution of limited funds based on current public infection risk. Making comparisons between Lyme disease and HIV merely highlights the disproportionate distribution of funding if one looks solely at case incidence rates for the two diseases.

Please reach out to marketing@GLA.org with any questions.

_______________

For more on the TBDWG:  https://madisonarealymesupportgroup.com/2018/12/14/tbdwg-on-surveillance-in-humans/

https://madisonarealymesupportgroup.com/2018/12/11/tbdwg-reviews-over-700-public-comments-uses-zero/

https://madisonarealymesupportgroup.com/2018/07/27/tbdwg-draft-report/

https://madisonarealymesupportgroup.com/2018/05/12/tweets-of-tbd-working-group-may-10-2018-meeting/

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

 

 

 

 

 

https://player.vimeo.com/video/212986148 <p><a href=”https://vimeo.com/212986148″>My Kid is Not Crazy: A search for hope in the face of misdiagnosis</a> from <a href=”https://vimeo.com/user31889281″>4 The Kids Films</a> on <a href=”https://vimeo.com”>Vimeo</a&gt;.</p>”>

Trailer here.

A doctor battles to save children with disabling mental illness.

Could the answer be simpler than everyone thinks?

Nine-year-old Kathryn was a normal, healthy child. She was a star student, athlete and dancer. In a matter of days, she would become totally dysfunctional. Kathryn had alarming rapid-onset OCD refusing to eat or drink. She had tremendous separation anxiety and would become panicked if her parents were not in sight. She had trouble sleeping and showed signs of age regression in vocabulary and handwriting.

How did this happen?

More than 30 years ago, a doctor discovered that an undiagnosed strep infection was the cause of one child’s disabling illness. More and more evidence was found: Strep was linked to symptoms normally chalked up to psychiatric illness. Modern medicine has been very slow to adopt this new idea.

“My Kid is Not Crazy,” a film by Tim Sorel, tracks the journey of six children and their families as they become tangled in the nightmare of a medical system that lacks the compassion and knowledge to treat these children.

MY KID IS NOT CRAZY IS THE CINEMATIC, PEDIATRIC EQUIVALENT OF BRAIN ON FIRE-MEETS-INFECTIOUS MADNESS. A FILM THAT WILL CHANGE THE WAY WE LOOK AT MENTAL ILLNESS FOREVER. -CHICAGO NOW

Rent on Vimeo for $3.99

_______________

https://www.sciencedirect.com/science/article/pii/S0022395618307027

This 2018 study shows that over 1/3 of kids with PANS have hallucinations are are more impaired than those without psychotic symptoms.  The authors admonish clinicians to screen for abrupt-onset of a symptom cluster including OCD and/or food refusal, with neuropsychiatric symptoms (enuresis, handwriting changes, tics, hyperactivity, sleep disorder). 

_______________

**Comment**

I post articles and videos on PANS/PANDAS, Autism, and other illnesses with an autoimmune label due to the fact that tick borne illness can be a part of this picture and a trigger which starts the downward cascade.

Please educate your loved ones about this potential as children are losing their childhoods to unbelievable misdiagnosis and suffering.

Vaccines can also be triggers:  https://madisonarealymesupportgroup.com/2017/09/21/aluminum-flawed-assumptions-fueling-autoimmune-disease-and-lyme/

https://madisonarealymesupportgroup.com/2017/12/02/scottish-doctor-gives-insight-on-lyme-msids/  He has also successfully treated a number of young women who fell ill after their HPV vaccination, which seems to have stimulated a latent Lyme infection to reactivate.

https://madisonarealymesupportgroup.com/2016/04/24/gardasil-and-bartonella/

Asymptomatic girls after receiving Gardasil activated dormant Bartonella which was confirmed by testing.

https://madisonarealymesupportgroup.com/2017/10/15/vaccines-and-retroviruses-a-whistleblower-reveals-what-the-government-is-hiding/  Data suggests that 6% of the U.S. population is harboring a retrovirus in their bodies that can develop into an acquired immune deficiency. This is not the well-known AIDS caused by HIV, but Acquired Immune Deficiency Syndrome (AIDS) associated with other retroviruses.  These non-HIV retroviruses were unintentionally introduced into humans over the past 75 years.  It began with trials of polio vaccines and yellow fever vaccines given in the early 1930s. This is when the first recorded cases of Chronic Fatigue Syndrome and autism appeared. It involved the use of laboratory mice to prepare vaccines for human use. [1]

More on PANS:  https://madisonarealymesupportgroup.com/2018/10/10/pans-pandas-awareness/

https://madisonarealymesupportgroup.com/2017/06/30/child-with-lymemsidspans-told-by-doctors-she-made-it-all-up/

https://madisonarealymesupportgroup.com/2018/08/01/the-3-pans-myths-that-are-ruining-lives/

 

 

 

 

 

 

https://www.news-medical.net/news/20180730/Study-finds-tick-bite-meat-allergy-as-most-common-cause-of-anaphylaxis.aspx

Study finds tick bite meat allergy as most common cause of anaphylaxis

An increase in the Lone Star tick population since 2006, and the ability to recognize the ticks as the source of “alpha gal” allergy to red meat has meant significantly more cases of anaphylaxis being properly identified.

A new study in Annals of Allergy, Asthma and Immunology, the scientific publication of the American College of Allergy, Asthma and Immunology (ACAAI) showed that at the University of Tennessee Health Science Center, alpha-gal ( a complex sugar found in red meat from beef, pork, venison, etc.) was the most common known cause of anaphylaxis. In previous studies of anaphylaxis, researchers were often unable to identify the source of the severe allergic reaction.

“Of the 218 cases of anaphylaxis we reviewed, 33 percent were from alpha gal,” says Debendra Pattanaik, MD, lead author of the study. “When we did the same review in 1993, and again in 2006, we had a great many cases where the cause of the anaphylaxis couldn’t be identified. That number of unidentified cases dropped from 59 percent in 2006 to 35 percent in this report – probably from the number of identified alpha gal cases. Our research clearly identified alpha gal as the cause of anaphylaxis in the majority of cases where the cause was detected. Food allergies were the second leading cause, accounting for 24 percent.”

The people in the study were seen between 2006 and 2016. The study notes that alpha gal allergy was first identified in 2008, so previous reviews wouldn’t have taken it into consideration. Due to increased awareness of red meat allergy, and more diagnostic testing available, alpha gal allergy went from an unknown entity to the most commonly identified cause of anaphylaxis at this center.

“We understand that Tennessee is a state with a big population of Lone Star ticks, and that might have influenced the large number of alpha gal cases we identified,” says allergist Jay Lieberman, MD, vice chair of the ACAAI Food Allergy Committee and a study co-author. “The Lone Star tick is predominantly found in the southeastern United States and we would expect a higher frequency of anaphylaxis cases in this region would be due to alpha gal. However, the tick can be found in many states outside this region and there are already more cases being reported nationwide.”

The remainder of the cases of anaphylaxis in the study were attributed to insect venom (18 percent) exercise (6 percent) systemic mastocystosis (6 percent) medications (4 percent) and other (3 percent).

A bite from the Lone Star tick can cause people to develop an allergy to red meat, including beef, pork and venison. The allergy is best diagnosed with a blood test. Although allergic reactions to foods typically occur rapidly, within 60 minutes of eating the food, in the case of allergic reactions to alpha-gal, symptoms often take several hours to develop. Because of the significant delay between eating red meat and the appearance of an allergic reaction, it can be a challenge to connect the culprit foods to symptoms. Therefore, an expert evaluation from an allergist familiar with the condition is recommended.

Allergists are specially trained to test for, diagnose and treat allergies. To find an allergist near you who can help create a personal plan to deal with your allergies and asthma, use the ACAAI allergist locator.

__________________

For more on Alpha Gal:  https://madisonarealymesupportgroup.com/2017/01/12/tick-related-red-meat-allergy-found-in-minnesota-wisconsin/  Yes, Martha, it’s here in Wisconsin.

https://madisonarealymesupportgroup.com/2018/07/28/what-the-mystery-of-the-tick-borne-meat-allergy-could-reveal/

https://madisonarealymesupportgroup.com/2018/06/27/alpha-gal-perioperative-management/

https://madisonarealymesupportgroup.com/2018/01/16/a-strange-itch-trouble-breathing-then-anaphylactic-shock/

https://madisonarealymesupportgroup.com/2018/05/04/arkansas-woman-develops-deadly-meat-allergy-after-tick-bite/  As Meritt points out on the Allergy & Asthma Clinic of Northwest Arkansas’ website, the alpha-gal allergy extends to beef, pork, gelatin and products that contain mammalian ingredients.  “That includes dairy products,” Burton said. “Mammal biproducts are in everything — daily vitamin supplements, shampoo, conditioners, hand and body lotions … all those things were keeping my system agitated. Pork or beef would just put it over the edge.”
A lot of vaccines are either made with animal products or have gelatin in it.

https://jameslyonsweiler.com/2018/12/15/for-health-officials-and-school-boards-asymptomatic-measles-infection-is-real/

For Health Officials & School Boards:  Asymptomatic Measles Infection is Real

By James Lyons Weiler

December, 15, 2018

There was a time when it was openly recognized that vaccinated individuals could become infected with wild-type measles. These infections are called subclinical infections (aka asymptomatic infections). We don’t talk about that very much anymore. In fact, two days ago I had a conference call with a high-ranking health official at the NYC Health Commission who claimed that it does not happen – specifically, that official stated that subclinical infections do not occur.

Given that this person is so obviously misinformed, I thought I would provide a literature resource for those who might not realize this reality: vaccinated individuals can, and have always, been known to be able to be infected with wild-type measles virus. Since this is true, the rare non-vaccinated child is not, in a highly vaccinated population, to be the primary source of new transmissions of measles. Instead, the vaccinated individuals with subclinical infections may be driving new infections in schools. It is therefore illogical, and quite unfair, to blame unvaccinated individuals when infected asymptomatic individuals can go to school unabated.

If we are to have public health policies based on science, this science must be given due consideration; otherwise, we would have public health policies based on something other than science. In reality, in highly vaccinated populations, measles can spread from a majority of vaccinated, to a minority of unvaccinated people, causing overt disease. In other words, the unvaccinated merely expose the circulating measles virus, and any child with a compromised immune system may be exposed even in a fully vaccinated population.

Not all full texts are freely available online, but some are. Here are some relevant examples from the primary scientific literature.

Nonclassic measles infections in an immune population exposed to measles during a college bus trip. Helfand RF https://www.ncbi.nlm.nih.gov/pubmed/?term=9829639

“Mild or asymptomatic measles infections are probably very common among measles-immune persons exposed to measles cases and may be the most common manifestation of measles during outbreaks in highly immune populations.”

Current status of measles in Japan. Nakayama T, Zhou J, Fujino M. https://www.ncbi.nlm.nih.gov/pubmed/12673398

“Measles infection is considered to provide lifelong immunity after an infection and, thus, live measles vaccines also induce longterm immunity. But long-term immunity is now considered to be an effect of natural boosts via subclinical reinfection. Subclinical infection has been demonstrated by sero-conversion, but the isolation or detection of the measles virus genome was rarely demonstrated”…

“Potential impediments to eradication include: (1) a lack of political will in some industrialized countries, (2) transmission among adults, (3) increasing urbanization and population density, (4) HIV epidemics, (5) waning immunity and the possibility of transmission from subclinical cases, and (6) risk of unsafe injection.”

Protective titres of measles neutralising antibody. Lee MS et al. https://www.ncbi.nlm.nih.gov/pubmed/11074481

“…only 1 vaccinee with HI titre #31 mIU/ml experienced typical measles symptoms and 13 vaccinees with HI titres #31 mIU/ml experienced subclinical infection.”

Effect of subclinical infection on maintaining immunity against measles in vaccinated children in West Africa. Whittle HC et al. https://www.ncbi.nlm.nih.gov/pubmed/?term=10023894

Subclinical measles occurred in 39 (45%) of 86 vaccinated children who were exposed to measles and in four (25%) of 16 unvaccinated children…”

Detection of measles virus genome in lymphocytes from asymptomatic healthy children. Sonoda S, Nakayama T. https://www.ncbi.nlm.nih.gov/pubmed/11536248

“Serological confirmation of subclinical re-infection was obtained by pre-exposure in household-exposed parents who developed asymptomatic secondary immune responseswith a concomitant increase in specific IgG neutralizing test antibodies and haemagglutination inhibition titres…Subclinical infection was confirmed in adulthood.”

“In Japan, measles virus has been circulating and asymptomatic infection has occurred frequently…”

The Clinical Significance of Measles: A Review Walter A. Orenstein Robert T. Perry Neal A. Halsey https://academic.oup.com/jid/article/189/Supplement_1/S4/823958

“People with inapparent subclinical measles virus infections are not known to transmit measles virus to household contacts.”

Detection of measles virus genome in bone-marrow aspirates from adults. Sonoda S, Kitahara M, Nakayama T. http://www.microbiologyresearch.org/docserver/fulltext/jgv/83/10/0832485a.pdf

Waning immunity and subclinical measles infections in England. Glass K, Grenfell BT. https://www.ncbi.nlm.nih.gov/pubmed/15364464

“A comparison of these cases … shows us that adding subclinical infections to the model also increases the number of clinical cases, as the subclinical infections increase the levels of circulating virus. This feature is more pronounced … because {when) vaccination
levels are higher … subclinical cases make up a greater proportion of the total cases.”

Subclinical measles infection in vaccinated seropositive individuals in arctic Greenland. Pedersen IR https://www.ncbi.nlm.nih.gov/pubmed/2815970

measles can spread from a majority of vaccinated, to a minority of unvaccinated people, causing overt disease.”

Isolation of measles virus from a naturally-immune, asymptomatically re-infected individual. Vardas E, Kreis S https://www.ncbi.nlm.nih.gov/pubmed/10443793

Risk analysis for measles reintroduction post global certification of eradication. Dr Ray Sanders. https://www.who.int/immunization/sage/7._Measles_post_eradication_risk_analysis.pdf

Effect of subclinical infection on maintaining immunity against measles in vaccinated children in West Africa.  https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(98)02364-2/fulltext

Measles eradication: is it in our future? Orenstein WA, Strebel PM, Papania M, Sutter RW, Bellini WJ, Cochi SL. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1446359/

The Re-Emergence of Measles in Developed Countries: Time to Develop the Next-Generation Measles Vaccines?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3905323/

Modeling the Impact of Subclinical Measles Transmission in Vaccinated Populations with Waning Immunity  Mossong, J et al. https://watermark.silverchair.com/150-11-1238.pdf

“In view of eradication, it is therefore important to investigate whether current vaccines perform well enough to prevent persistence of wild virus in highly or even fully vaccinated populations.”

jameslyonsweiler
Dr. Lyons-Weiler is a research scientist and author of three books, the latest of which is “The Environmental and Genetic Causes of Autism”. He is available for speaking engagements and book signing events at your location. To contact, follow on twitter @lifebiomedguru, email ebolapromo@gmail.com, and connect via LinkedIn https://www.linkedin.com/in/jameslyonsweiler

 

 Approx. 7 Min.

Dec. 17, 2018

Written by Joseph Mercola

Story at-a-glance

  • In lab tests conducted at Johns Hopkins, essential oils from garlic and other herbs and medicinal plants were found to be highly effective at destroying the bacterium that causes Lyme disease
  • At least 300,000 Americans are diagnosed annually with Lyme disease, which is a bacterial infection spread by ticks commonly found in the U.S. and at least 60 other countries
  • Treating Lyme disease is often complicated by coinfections, nutrient deficiencies and toxin overload, as well as the fact many of its symptoms mimic illnesses like fibromyalgia and multiple sclerosis
  • While conventional medicine most often turns to long-term antibiotic use to treat Lyme, I encourage you to investigate the many natural solutions available, including the use of antioxidants, probiotics and lumbrokinase
  • If you are not finding the help you need and your condition is worsening, you may want to consider learning more about the treatment protocol recommended by Dr. Dietrich Klinghardt, one of the leading authorities on Lyme disease

Lab-based research conducted at Johns Hopkins School of Public Health suggests various essential oils, including garlic, can effectively kill persistent forms of Lyme disease bacterium. While clinical trials are needed to validate the lab-based results, this is good news for anyone who had previously been relying on antibiotics alone to treat this life-threatening, tick-based disease.

Notably, 10 of the 35 essential oils tested showed strong killing activity against dormant and slow-growing “persister” forms of Lyme disease bacterium.1

If you are struggling with Lyme disease, I encourage you to look beyond conventional treatment, which often focuses on the use of long-term antibiotics. You owe it to yourself to investigate essential oils and other natural solutions, which I highlight below.

Essential Oils Shown To Be Effective for Treating Lyme Disease

As presented in the featured video, a new study published in the journal Antibiotics2 suggests essential oils such as garlic and eucalyptus may be useful in treating Lyme disease.

Interested in the oils’ strong antibacterial properties and many other health benefits, a team of researchers from the Johns Hopkins School of Public Health conducted lab tests designed to treat Lyme bacterium with 35 essential oils.

Previously, lead study author Dr. Ying Zhang, professor in the department of molecular microbiology and immunology, and his colleagues identified five essential oils, including oregano, cinnamon bark and citronella, that have higher antipersister activity than the commonly used Lyme antibiotic drug daptomycin.3 Results of the current research revealed:4,5,6

  • Ten of the 35 essential oils that were tested showed “strong activity” against persister forms of Lyme disease bacterium
  • Essential oils derived from allspice berries, cinnamon bark, cumin seeds, eucalyptus, garlic cloves, myrrh trees and thyme leaves are among those found to effectively combat persister forms of Lyme disease
  • Five of these oils were effective against dormant forms of the Lyme bacterium in a concentration of only 1 part per 1,000
  • Essential oils from allspice berries, garlic, may chang trees, myrrh trees and spiked ginger lily not only eradicated all Lyme disease bacteria in seven days, but also prevented regrowth in 21 days

About the study outcomes, Zhang stated, “We found that these essential oils were even better at killing the ‘persister’ forms of Lyme bacteria than standard Lyme antibiotics. At this stage, these essential oils look very promising as candidate treatments for persistent Lyme infection, but ultimately we need properly designed clinical trials.”7

Given the study outcomes, essential oils are certainly worth consideration when it comes to addressing Lyme symptoms. Later in this article, I will share other natural remedies you may want to consider. For now, let’s take a closer look at what causes the disease and how it is most commonly contracted.

What Causes Lyme Disease?

Lyme disease is caused by a spirochete — a corkscrew-shaped bacterium called Borrelia burgdorferi. It is primarily transmitted by deer ticks and black-legged ticks found in grassy and wooded areas throughout the U.S. and at least 60 other countries.8

Lyme is sometimes accompanied by a characteristic bullseye rash and may include flu-like symptoms such as: body aches, fatigue, fever, headaches and stiff or swollen joints.

As I have often mentioned, early treatment is vital because it may help you avoid future complications such as chronic joint inflammation (Lyme arthritis), cognitive defects, heart rhythm irregularities and neurological symptoms.

Quite often, Lyme disease can be complicated by factors such as coinfections, nutrient deficiencies and toxin overload.9 LymeDisease.org provides the following facts about the disease:10

  • Most people contract Lyme from the bite of an immature tick — and the bite is often so tiny and painless, you may not realize you’ve been bitten
  • An undisturbed tick can feed for several days; the longer it is attached to your body, the greater the chances it will transmit Lyme and other pathogens into your bloodstream
  • Lyme, which is known as “The Great Imitator,” is very challenging to diagnose because its symptoms mimic conditions such as amyotrophic lateral sclerosis (ALS), chronic fatigue syndrome, depression, fibromyalgia and multiple sclerosis
  • Lyme disease can affect any organ of your body, including your brain and nervous system, muscles and joints and even your heart

Who Gets Lyme Disease?

Lyme disease is no respecter of persons and one bite from a tick the size of a poppy seed may be the only thing separating you from this devastating illness. At least 300,000 Americans are diagnosed with Lyme disease annually.11

According to the U.S. Centers for Disease Control and Prevention (CDC), Lyme disease cases are mainly concentrated in the Northeast and upper Midwest, with 14 American states accounting for more than 96 percent of the cases reported to the CDC.12

The people at greatest risk of picking up a Lyme-infected tick include children and older adults, as well as firefighters, park rangers and others who spend time in areas known to increase their exposure to ticks.13

Antibiotic Treatment for Lyme Disease Is Not Always Effective

In most cases, the first line of treatment for Lyme disease usually involves the administration of antibiotics such as amoxicillin, cefuroxime or doxycycline for two to four weeks. That said, antibiotics are not always effective. It’s also important to note that the overuse of these drugs contributes to antibiotic resistance, which is becoming an increasingly bigger issue worldwide.

A 2013 study suggested 36 percent of antibiotic-treated patients continued to suffer from fatigue six months after taking the medication, whereas 20 percent experienced ongoing joint or musculoskeletal pain and 45 percent dealt with persistent neurocognitive symptoms.14

This poorly understood condition that lingers after standard treatment has been completed is known as “persistent Lyme infection” or “post-treatment Lyme disease (PTLDS) syndrome.”15 While the cause of so-called persistent Lyme infection is unknown, experts have observed that the Lyme bacterium can enter a dormant stage in which its cells multiply very slowly or don’t divide at all.

As such, these so-called persister cells are known to be more resistant to antibiotics. About this aspect of Lyme disease, authors of the Johns Hopkins study stated:16

“We found that the variant persister forms such as round bodies, microcolonies and biofilms with increasing degree of persistence in vitro, cannot be killed by the current Lyme antibiotics or even persister drugs like daptomycin alone. [T]hey can only be killed by a combination of drugs that kill persisters and drugs that kill the growing forms.

These observations provide a possible explanation in support of persistent infection despite antibiotic treatment in vivo.

Although daptomycin has good antipersister activity, it is expensive and is an intravenous drug and difficult to administer and adopt in clinical setting, and it has limited penetration through blood brain barrier (BBB). Thus, there is interest to identify alternative drug candidates with high anti-persister activity.”

Natural Strategies to Fight Lyme Disease

As mentioned, conventional Lyme treatment usually focuses on antibiotics, which often stop short of addressing the underlying issues associated with the disease. Due to the damage it will do to your gut microbiome, I do not recommend long-term antibiotic use for Lyme.

The use of antibiotics also increases your risk of fungal or yeast infections. Moreover, antibiotics tax your natural immune function and increase your risk of antibiotic-resistant infections.

Rather than choose antibiotic therapy as your primary means of treating Lyme, you’d be wise to investigate the many natural alternatives first, or, at least use the natural remedies in concert with any recommended pharmaceutical medications. You may find the following nutritional supplements useful in addressing Lyme disease:

Andrographis and artemisinin — herbs that treat a Lyme coinfection called Babesia Krill oil — this omega-3 powerhouse helps reduce inflammation and relieve Lyme symptoms
Astaxanthin — a powerful antioxidant that neutralizes toxins and relieves joint pain Probiotics — promotes healthy gut flora and boosts your immunity
Cilantro — a natural chelator for heavy metals Quercetin — an antioxidant known to reduce histamine, which is usually high in Lyme patients
CoQ10 — a potent antioxidant that alleviates muscle pain, boosts cardiac health and reduces brain fog Resveratrol — this antioxidant helps with detoxification and may treat the common coinfection called Bartonella
Curcumin — the active ingredient in the spice turmeric, which eliminates neurological toxins and helps reduce brain swelling Serrapeptase helps dissolve biofilms
GABA and melatonin — two great sleep supplements that will help address insomnia, a common complaint of Lyme sufferers Transfer factors — help boost your immune function
Grapefruit seed extract — known to kill bacteria, Candida and parasites and may help treat the Borrelia bacterium in cyst form Whey protein concentrate — may be useful as a dietary supplement

Lumbrokinase Also Shown to Help Treat Lyme

Beyond the natural remedies mentioned above, lumbrokinase, a group of six proteolytic (protein digesting) enzymes derived from earthworms, has been successfully paired with antimicrobial remedies for the treatment of Lyme disease.

Lumbrokinase is believed to effectively penetrate through thick clumps of gut bacteria known as biofilms, which are one of several factors involved with Lyme. When pathogenic bacteria hide within biofilms, they can feed and replicate out of the reach of your immune system.

As such, they remain strong and unaffected by any antimicrobial medications, including antibiotics and herbs, you may be taking. The fact lumbrokinase is helpful in breaking down fibrinogen is an important aspect of Lyme treatment because the pathogenic bacteria use fibrinogen, which they convert to fibrin, to strengthen their network.17

Researchers studying the effects of lumbrokinase18 say earthworms have been used for thousands of years within traditional medicine in Asian countries such as China, Japan and Korea. In these countries, dry earthworm powder taken orally has been shown to promote healthy blood circulation.

Dr. Miguel Gonzalez, a functional, integrative and holistic medicine specialist from Thousand Oaks, California, and creator of the Lyme People website, suggests lumbrokinase, “appears to assist in dissolving the excess fibrin that covers and hides the bacteria, is involved in the regulation of blood clotting and also eliminates the abnormal proteins that are released as a result of the bacteria’s activity.”19

You May Want to Try Klinghardt Academy’s Lyme Treatment Protocol

My mentor Dr. Dietrich Klinghardt, founder of the Klinghardt Academy in Woodinville, Washington, is one of the leading authorities on the treatment of Lyme disease. Having been used successfully to restore health to hundreds of patients, his Lyme disease treatment protocol is most definitely something you should check out, especially if you have been unable to get the help you need elsewhere.

Be Vigilant: Preventing Lyme Disease Is Your Best Option

Lyme disease is a complex, controversial and extremely challenging condition to treat, making prevention your safest and best option. Your first line of defense is to take precautions to avoid the ticks that transmit the disease. After all, no tick bites, no Lyme disease. Because the ticks can be as small as poppy seeds, you must be vigilant to safeguard yourself, your loved ones and your pets from ticks.

Whatever you do, do not spray your body or your clothes with insect repellant containing N,N-Diethyl-m-toluamide, also known as DEET. Because DEET is a known neurotoxin,20 I recommend avoiding all DEET-containing products. If you live or spend time in a high-risk area, you can protect yourself from tick bites by:21,22

  • Avoiding tick-infested areas such as densely wooded areas and always walk in the middle of trails to avoid brushing against tall grasses and other plant material that may house ticks
  • Looking for ticks on your body and hair immediately upon returning from a high-risk area and continuing to check your body, hair and bedding daily for several days afterward
  • Wearing long sleeves and pants, as well as closed shoes and a hat, when venturing into wooded areas
  • Checking your pets for ticks, which can latch onto collars and fur
  • Removing ticks properly and, if possible, keeping them alive; for detailed instructions on handling ticks, visit the lymedisease.org tick removal page

__________________

**Comment**

Please remember, this study is in vitro (in a lab) not in vivo (the human body).  I believe they are in the process of mouse studies.

Back to EO’s.  My husband and I both used the combination of clove, cinnamon, and oregano (2 drops each, so 6 drops in a capsule twice a day for a grand total of 12 drops of EO’s).  I also added 2 drops of turmeric for inflammation as well as 8 or so drops of black seed oil as a good fat).  We used this protocol 1 week out of every month as a maintenance program as we have treated extensively with both antibiotics, herbs, blood ozone under UV light, and with high dose vitamin C IV’s for over FIVE YEARS.

WE BOTH RELAPSED ON THIS EO maintenance program.  

I got the EO idea from here:  https://madisonarealymesupportgroup.com/2017/10/13/oregano-cinnamon-and-clove-found-to-have-high-anti-persister-activity-for-bb/

When I went to the ILADS convention I happened to catch Greg Lee, who uses many modalities in treating Lyme/MSIDS, including liposomal EO’s & I ran my protocol by him.  He agreed that the protocol seemed sound and of the correct strength.

However, again, we BOTH relapsed.

I do not believe at this point that EO’s ALONE with conquer this beast.  They very well could help and in combination with other modalities could be quite powerful.  Also, the other detail is perhaps this only works on a daily basis with no breaks.  So, either the dosage is too low, we didn’t take it often enough, or it just flatly doesn’t work.

I must add a final personal observation because I know the desperation out there is very great.  The “naturalists” who hate antibiotics always jump on these in vitro studies as if they are the 10 commandments or a sure thing.  BTW:  I hadn’t taken abx for over 20 years until Lyme/MSIDS and consider myself a quasi-naturalist! Please be aware of folks’ well-meaning biases.  In the end, it’s your body and your choice what treatment you will follow.  Do your homework.  It’s complex and much is still unknown.  I chose to go with the biggest bang for my buck that I actually saw noticeable improvement upon.  This looks differently on everyone.  For some, abx doesn’t appear to help them and in fact for some, they flatly can not tolerate them.  If this is true for you, then by all means, don’t use them!  However, also keep in mind that how you feel during this nightmare is quite different than anything you’ve ever experienced before.

In other words, I felt like _ _ _ _ on a stick for the entire 5 years of treatment with a few “good days.”  Treatment is hard.  But, you know you are making progress when you notice a herx.  Managing that herx is an entirely different matter and books could be written about this, but here’s a start:  https://madisonarealymesupportgroup.com/2015/08/15/herxheimer-die-off-reaction-explained/

https://madisonarealymesupportgroup.com/2015/12/06/tips-for-newbies/

https://madisonarealymesupportgroup.com/2017/06/28/jarisch-herxheimer-a-review/  At the end of the article I explain my herxes.  I would like to also add that since that time I’ve started taking MSM daily with great success for pain.  In fact, I’m pain-free and have been for some time.  I know; however, that when pain returns, that’s the beginning of my spiral downward and the sign of a relapse.  Upon another stint of abx (usually 2-3 months) I’m back to normal, but this is how it has played out for me, my husband, and my LLMD states this is how it plays out for many others she treats. I tried MSM earlier while IN treatment to no effect but now that I’m off treatment it works well.  I do believe the pathogen load needs to be decreased substantially, at least in my case, for the MSM to work.  Please see this article on it:  https://madisonarealymesupportgroup.com/2018/03/02/dmso-msm-for-lyme-msids/

Please remember, these experiences are my own so yours may be slightly different depending on your presentation.  I feel it’s important to share this as it’s important to collect as much knowledge as you can, but always remembering that this complex illness varies from person to person.  And lastly, please find a knowledgable health professional.  One who is trained by ILADS and is open-minded.

Two heads are definitely better than one when it comes to tick-borne illness!

P.S.  I didn’t notice a darn thing on stevia or grapefruit seed extract.  My LLMD feels they aren’t strong enough.  For me, Tinidazole was a game changer as well as minocycline for the ability to cross the blood/brain barrier.  I NEVER only took one thing.  I was on 3-4 things simultaneously throughout treatment but we did pulse these.

Read more here on Tindy: https://www.dovepress.com/evaluation-of-in-vitro-antibiotic-susceptibility-of-different-morpholo-peer-reviewed-article-IDR
However, both metronidazole and tinidazole had far superior action:
Metronidazole led to reduction of spirochetal structures by ~90% and round body forms by ~80%. Tigecycline and tinidazole treatment reduced both spirochetal and round body forms by ~80%–90%.
In terms of qualitative effects, only tinidazole reduced viable organisms by ~90%. Following treatment with the other antibiotics, viable organisms were detected in 70%–85% of the biofilm-like colonies.

LLMD’s almost all use drug combinations due to the complexity of the organism as well as to ward off any potential resistance, and the fact coinfections are often involved. For examples: https://madisonarealymesupportgroup.com/2016/02/13/lyme-disease-treatment/

More on Mino:  https://madisonarealymesupportgroup.com/2017/06/04/minocycline-for-ms-and-much-more/

 

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/23763774?

Laboratory testing for Lyme disease

Carl Tuttle
Hudson, NH, United States
DEC 15, 2018 —

Direct detection laboratory testing (DNA/PCR Sequencing) is used for many infections (Ebola (1), Zika (2), Bartonella (3) etc.) but not Lyme disease.

  1. Ebola RealStar® Filovirus Screen RT-PCR Kit 1.0
    https://www.qiagen.com/no/shop/realstar-filovirus-screen-rt-pcr-kit-1-0/#orderinginformation
  2. CDC Lauds New DNA Test for Zika in Blood
    http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/58622?xid=nl_mpt_DHE_2016-06-18&eun=g750897d0r
  3. In May of 2012 the CDC announced the Development of a Novel Genus-specific Real-time PCR Assay for Detection and Differentiation of Bartonella Species and Genotypes
    http://www.ncbi.nlm.nih.gov/pubmed/22378904

For over two decades (Dearborn conference 1994) The U.S. Centers for Disease Control has avoided and denounced all direct detection methods for Lyme disease while promoting the faulty/misleading two tier antibody algorithm. Serology for Lyme disease cannot be used to gauge treatment failure or success so it is the ideal tool for concealing chronic Lyme disease.
The CDC does use DNA/PCR testing however to verify infection in postmortem patients who died suddenly of Lyme carditis. (1, 2, 3)

  1.  A case report of a 17-year old male with fatal Lyme carditis
    http://www.cardiovascularpathology.com/article/S1054-8807(15)00025-3/abstract?rss=yes
  2. Three Sudden Cardiac Deaths Associated with Lyme Carditis: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6249a1.htm?s_cid=mm6249a1_w
  3. Cardiac Tropism of Borrelia burgdorferi: An Autopsy Study of Sudden
    Cardiac Death Associated with Lyme Carditis. (March 2016)
    http://ajp.amjpathol.org/article/S0002-9440(16)00099-7/abstract
So it would appear that you have to die first to obtain irrefutable proof of Lyme disease.

Please see the following letter addressed to the Director of Quest Diagnostics-New England regarding current antibody testing for Lyme disease. These tests are the root cause of unimaginable pain and suffering.

——— Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: Salim.E.Kabawat@questdiagnostics.com, Brett.Giroir@hhs.gov, Alex.Azar@HHS.GOV, tickbornedisease@hhs.gov,
Cc: (64 undisclosed recipients)
Date: December 13, 2018 at 12:10 PM
Subject: Lyme disease Western Blot test (2009 communication follow-up)

Dec 13, 2018

Quest Diagnostics-New England
415 Massachusetts Ave.
Cambridge, MA 02139
Attn: Salim E. Kabawat, M.D. Medical Director

Dear Dr. Kabawat,

I would like to call attention to the following publication coauthored by Paul Mead, MD, MPH Acting Branch Chief of the Division of Vector-Borne Diseases at the CDC in Fort Collins, Colorado:

Direct Diagnostic Tests for Lyme Disease
Clinical Infectious Diseases, ciy614, https://doi.org/10.1093/cid/ciy614

Published: 11 October 2018 Paul S Mead

Excerpt:

“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.”

Has Dr. Paul Mead of the CDC reached out to you to ask that you include this disclaimer in your Western blot serology test results for Lyme disease?

Dr. Neil Spector’s serology was repeatedly negative leaving his Lyme untreated for four years resulting in the need of a heart transplant. [1]

Four negative Lyme test results led to a misdiagnosis of Multiple Sclerosis prompting a lawsuit in Pennsylvania.

IN THE SUPREME COURT OF PENNSYLVANIA MIDDLE DISTRICT
https://www.dropbox.com/s/9qdt78jnq5i6lne/PA%20Lawsuit%20MS%20Misdiagnosis.pdf?dl=0

Per the email thread below, I had this conversation with you nine years ago. How many patients since then have been misdiagnosed and left untreated because there is no disclaimer on your test results informing the patient (and physician) that a negative result does not necessarily mean that you don’t have Lyme disease?

Don’t you think it is time for change; full disclosure perhaps?

A response to this inquiry is requested.

Sincerely,
Carl Tuttle
Lyme Endemic Hudson, NH

Cc: ADM Brett P. Giroir, M.D., Assistant Secretary for Health

Reference:
1. Neil Spector “Gone in a Heartbeat”
https://www.bayarealyme.org/blog/story/neil-spector/

2009 Response from Director Kabawat:
———- Original Message ———-
From: Kabawat, Salim E
To: runagain@comcast.net
Cc: Panarelli, Robert M
Date: June 12, 2009 at 2:17 PM
Subject: Lyme disease Western Blot test

Mr. Carl Tuttle 33 David Dr
Hudson, NH 03051

Greetings Mr. Tutle; Regarding your question on Lyme disease Western Blot Test, Quest Diagnostics follows CDC guidelines regarding Lyme reporting. See MMWR August 11, 1995 / 44(31);590-591 “It was recommended that an IgM immunoblot be considered positive if two of the following three bands are present: 24 kDa (OspC) * , 39 kDa (BmpA), and 41 kDa (Fla) (1). It was further recommended that an that IgG immunoblot be considered positive if five of the following 10 bands are present: 18 kDa, 21 kDa (OspC) *, 28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa (2).”

Sincerely;
Salim E. Kabawat, M.D.

Quest Diagnostics-New England| Medical Director | 415 Massachusetts Ave., Cambridge, MA 02139 | phone617.520.8242 | fax 617.520.7703 |salim.e.kabawat@questdiagnostics.com| www.QuestDiagnostics.com

2009 follow-up letter to Dr. Kabawat: (No response)

———- Original Message ———-
From: runagain@comcast.net
To: Salim E Kabawat <Salim.E.Kabawat@questdiagnostics.com>
Cc: Robert M Panarelli <Robert.M.Panarelli@questdiagnostics.com>
Date: June 17, 2009 at 1:06 PM

Subject: Re: Lyme disease Western Blot test

June 17, 2009
Quest Diagnostics-New England
415 Massachusetts Ave.
Cambridge , MA 02139
Attn: Salim E. Kabawat, M.D. Medical Director

Dear Dr Kabawat,

Each week for the past month I submitted the following question through your online patient inquiry portal:

“Could you please tell me why Quest Labs’ Western blot Lyme test doesn’t include band 31 and 34? Is it possible that your exclusion of these bands is missing many Lyme cases since band 31 and 34 are highly specific to Borrelia burgdorferi and were originally chosen for vaccine development?”

On June 9, 2009 you responded to my inquiry referring to a thirteen year old CDC guideline for Lyme disease reporting dated August 11, 1995
(MMWR 44(31);590-591). You then cut and pasted the following information from that guideline:

“It was recommended that an IgM immunoblot be considered positive if two of the following three bands are present: 24 kDa (OspC) * , 39 kDa (BmpA), and 41 kDa ( Fla ) (1). It was further recommended that an that IgG immunoblot be considered positive if five of the following 10 bands are present: 18 kDa, 21 kDa (OspC) *, 28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa (2).”

On February 11, 2005 the Centers for Disease Control and Prevention issued the following caution (MMWR Morb Mortal Wkly Rep 2005; 54:125–6) regarding testing for Lyme disease:

Health-care providers are reminded that a diagnosis of Lyme disease should be made after evaluation of a patient’s clinical presentation and risk for exposure to infected ticks, and, if indicated, after the use of validated laboratory tests.

As I review my wife and daughter’s Western blot lab results which were ordered through Quest laboratory Apr 16, 2009 and May 7, 2009 respectively, I cannot locate the disclaimer reminding the physician that a diagnosis of Lyme disease should be made after evaluation of the patient’s clinical presentation or risk for exposure to infected ticks. In fact, my daughter’s primary care physician called to inform her that she didn’t have Lyme disease based on your lab results alone without considering clinical symptoms whatsoever.

The attached CDC deer tick/Lyme study concludes that we are living in an area with one of the highest rates in the state. Residents in our area have a 77% chance of contracting Lyme through a deer tick bite. Physicians in this “endemic area” as we have experienced are not familiar with the clinical manifestations of Lyme especially when the patient does not present with the typical bulls eye rash or recall experiencing a tick bite as is the case 50% of the time.

UMass Amherst NH deer tick/Lyme study:
https://www.dropbox.com/s/kvxnp7tffoy4yas/NH%20Tick%20StudyText%20added.doc?dl=0

Your lab tests are contributing to the problem as all the physician sees is the word NEGATIVE on the results.

Under the Infectious Conditions for Public Health Surveillance page, the Centers for Disease Control updated its Lyme Case Definition in 2008 stating the following:

“This surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis

This includes the thirteen year old 1995 CDC guideline for reporting purposes that you referred to in your original response.

Lyme literate Infectious Disease Specialists recognize that it is not necessary to have five positive Western blot IgG bands or two IgM bands in order to diagnose Lyme disease. Those guidelines were strictly developed for surveillance purposes only.

Your lab results neglect to mention any of this so Quest Labs along with other commercial labs is misleading the physician. I don’t believe this is intentional but more on the lines of complacency.

I have first hand experience after chasing an unresolved fatigue for twelve years as my Western blot results show only two positive bands. I would like to mention that private Lyme testing labs (i.e. IGeneX Labs) are informing the patient with disclaimers stating that diagnosis should not be based on laboratory tests alone and results should be interpreted in conjunction with clinical symptoms and patient history.

There is a moral responsibility to provide accurate information as I have identified in this letter. I would like to remind you of the following statement found on your Company Info page:

“Quest Diagnostics is People. Dedicated people who understand that behind every specimen and result there is a human life

Our Vision, Mission & Values
Accountability

As a company and as individuals, we accept full responsibility for our performance and acknowledge our accountability for the ultimate outcome of all that we do. We strive for continuous improvement, believing that competence, reliability, and rigorous adherence to process discipline are the keys to excellence

How many Lyme patients have been misdiagnosed and told they do not have Lyme disease due to your “NEGATIVE” lab results and missing disclaimers? There is a dire need to change your methods and educate the physician to avoid patient suffering by missing the window of opportunity for treatment.

Sincerely,
Carl Tuttle
Hudson , NH 03051

_________________

More on testing:  https://madisonarealymesupportgroup.com/2018/09/12/lyme-testing-problems-solutions/

https://madisonarealymesupportgroup.com/2018/01/16/2-tier-lyme-testing-missed-85-7-of-patients-milford-hospital/

https://madisonarealymesupportgroup.com/2018/10/13/direct-test-for-ld-carl-tuttle-chews-up-cdc-spits-them-out/

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.