Archive for the ‘research’ Category

Columbia Clinical Trials Network Seeks Treatment Approaches From Public, Clinicians, & Others

https://lymediseaseassociation.org/resources/clinical-trials-studies/columbia-clinical-trials-network-seeks-treatment-approaches-from-public-clinician-others/

Columbia Clinical Trials Network Seeks Treatment Approaches From Public, Clinicians, & Others

From Columbia Clinical Trials Network: In recognition of a severe unmet need, the Steven and Alexandra Cohen Foundation’s grant to Columbia University has established the first national Columbia Clinical Trials Network for Lyme and other Tick-borne Diseases [www.lymectn.org]. The Research Network starts with a team of leading investigators, including Dr. Brian Fallon at Columbia University Irving Medical Center in New York City, Dr. John Aucott at Johns Hopkins University Medical Center in Baltimore Maryland, and Dr. Roberta DeBiasi at Children’s National Hospital in Washington D.C.

Providing oversight to ensure that the highest-quality clinical trials are undertaken, the Clinical Trials Network will:

  • provide internal funding support for small pilot studies
  • assist investigators in protocol design and statistical research planning
  • establish and manage a national case registry
  • create a data management system for multi-site clinical trials
The clinical trials network will be a powerful engine to drive large-scale clinical trials and potentially transformational early-stage research.

To generate as many ideas as possible and to hear directly from the front lines of clinical experience, Columbia CTNCC invites public, community clinicians, and other stakeholders to submit their ideas on treatment approaches. These ideas may spark off development of a pilot study and be included in clinical trials conducted at one of the CTN nodes.

You may contribute to a groundbreaking research project in the field of Lyme and the tick-borne diseases.

The deadline for the first round of submissions for treatment research ideas from the general public is July 1, 2021. The submission period opened June 1.

To submit your suggestions for treatments, please go to www.lymectn.org and submit on the “Treatment Research Idea Hub”.

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From the LDA:  The Lyme Disease Association Inc (LDA) President Pat Smith, had this to say about the release,

“This is a great opportunity for individuals to provide suggestions which might lead to research on a treatment which could lead to a cure or to a better life for many of our sickest Lyme/TBD patients. I hope those who have promising ideas will submit them to the Columbia CTNCC for consideration.”

Category:

Activism, research, Treatment

Review of Evidence Supporting IDSA Guidelines EM Treatment in US

https://lymediseaseassociation.org/about-lyme/research-articles/peer-reviewed-articles/review-of-evidence-supporting-idsa-guidelines-em-treatment-in-us/

Review of Evidence Supporting IDSA Guidelines EM Treatment in US

2014 ElizabethMaloneyMD
Elizabeth Maloney, MD

The IDSA guidelines for Lyme disease contain 2 recommendations for antibiotic therapy for patients with erythema migrans (EM) rashes. The first recommendation identified which antibiotics were preferred and the second specified therapy duration.

In “Evidence-Based, Patient-Centered Treatment of Erythema Migrans in the United States,” Antibiotics 2021, author Elizabeth L. Maloney, MD, reviews the US trial evidence on EM rashes, problems of the IDSA recommendations considering that evidence, and provides evidence-based patient-centered strategies for managing patients with EM.

“The EM rash is the hallmark finding of early disease,” along with other symptoms. “In light of the physical and financial costs, identifying and promoting highly effective therapeutic interventions for US patients with erythema migrans (EM) rashes that return them to their pre-infection health status should be a priority.” 

The paper states:

“when promptly diagnosed and appropriately treated with antibiotics, early Lyme disease is curable.” Untreated and inadequately treated infections can progress to long-term sequalae. Patient-centered care–defined by the National Academy of Medicine—“…is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions. Patient-centered outcomes are outcomes that matter to patients, such as reductions in symptoms or improvements in quality of life.” In recent times, patient-centered outcomes are becoming part of trial designs.

Dr. Maloney uses a Medline search with specified criteria to identify the trials conducted in the US for the named antibiotics recommended by IDSA Lyme guidelines.  There were 25 results of which 8 met the search criteria, other 17 were EM trials in Europe, disseminated disease in Europe, European antibiotic retreatment, culture difficulty, and tick bite prophylaxis. The US trials were old, were small, and 2 had high non completion rates of 40%+ and two others had single arm with 20%+ non—completion, thus Dr. Maloney indicates these should not be included to determine treatment efficacy.

The paper goes on to examine the remaining US trials, several of which used disease centered endpoints, not patient centered endpoints, and all those trials used what is currently considered outdated statistical methodology, pointing out the weaknesses of the evidence used by IDSA. In the conclusion, Dr. Maloney highlights the need for more research.

Click here to read the entire study

Click here to read Johns Hopkins Lyme Research Center Challenges IDSA Guidelines & Addresses Lyme-COVID

Click here to see video of Bransfield & Smith Discuss IDSA Guidelines

Category:

Activism, Lyme, research, Treatment

COVID Injection Benefit: Save 3, Kill 2

https://www.mdpi.com/2076-393X/9/7/693

The Safety of COVID-19 Vaccinations—We Should Rethink the Policy

by Harald Walach1,2,3,*, Rainer J. Klement4 and Wouter Aukema5
*Author to whom correspondence should be addressed.
Academic Editor: Ralph J. DiClemente
Vaccines 2021, 9(7), 693; https://doi.org/10.3390/vaccines9070693
Received: 2 June 2021 / Revised: 19 June 2021 / Accepted: 21 June 2021 / Published: 24 June 2021
(This article belongs to the Section COVID-19 Vaccines and Vaccination)

Abstract

Background: COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits.
Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases with fatal side effects.
Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations.

For three deaths prevented by vaccination we have to accept two inflicted by vaccination.

Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy. View Full-Text
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For more:

Regarding efficacy:  https://madisonarealymesupportgroup.com/2021/05/06/vaccine-makers-destroy-covid-vaccine-safety-studies/

Excerpt:

  • Makers of COVID-19 vaccines are now destroying long-term safety studies by unblinding their trials and giving the control groups the active vaccine, claiming it is “unethical” to withhold an effective vaccine
  • In so doing, they make it virtually impossible to assess any long-term safety and effectiveness, and the true benefit versus cost
  • It’s ironic, because vaccine mandates are being justified on the premise that the benefit to the community is more important than an individual’s risk of harm. 
  • Vaccine makers are also very careful about only referencing relative risk, not absolute risk. By doing so, the vaccines appear far more protective than they actually are. It’s a commonly used statistical trick that makes them look more effective than they are. 

When absolutely risk is taken into account, the effectiveness of the COVID injections is LESS THAN 1%.

Lastly, a “vaccine” isn’t needed for a disease that has effective treatments; however, these treatments are maligned, censored, and ignored because they want to push their lucrative injections.  On top of it all is the fact COVID has the mortality rate of the seasonal flu.

Category:

research, vaccines, Viruses

Preventing Tick Bites on a Child Proves Challenging

https://danielcameronmd.com/tick-bite-prevention-methods-failing-children/

PREVENTING TICK BITES ON A CHILD PROVES CHALLENGING

tick-bites-on-child

Children account for 25% of all Lyme disease cases in the U.S., according to the Centers for Disease Control and Prevention (CDC). Unfortunately, tick bite prevention methods are failing our children, as 5-to 9-year-olds continue to be at the highest risk for developing Lyme disease.

By

A study published in April 2021 looked at the frequency of emergency room visits due to tick bites. The authors examined “ED tick bite visits during January 2017-December 2019 by sex, age group, U.S. region, and seasonality,” writes Marx et al. [2] Their findings revealed that tick bites on a child under the age of 9 accounted for the highest number of ED tick bite visits.

During a 36-month period, there were 149,364 ED tick bite visits. The incidence was highest in the Northeast with the larger peak occurring during the spring and early summer, the authors write.

The findings support previous studies which explored the incidence of tick bites among various age groups and the associated risk of exposure to tick-borne diseases.

In 2016, more than 3,000 ticks (n=3551) were submitted to the University of Massachusetts Laboratory of Medical Zoology, as part of a passive surveillance study. The vast majority of ticks provided over a 7–year period were Ixodes scapularis ticks (or blacklegged ticks) from Massachusetts (N ≡ 2088). [3]

Tick bites on a young child pose dangers

Investigators found that children under age 9 had the largest proportion of tick bites. According to Xu and colleagues, 39.7% were identified as nymphs, while 34.6% were adult ticks.

Nearly 200 ticks were collected from children under age 5. Another 200 ticks were collected from children ages 5 to 9. Nearly 90 ticks were collected from adolescents.

Deer ticks were the most common ticks attached to a child. Out of the 3,551 tick bites, 89% were due to deer ticks.

Additionally, 98% of the 1700 adult ticks submitted were female.

The overall infection rate for Borrelia burgdorferi, Anaplasmosis phagocytophilum, and Babesia microti in human-biting ticks were 29.6%, 4.6%, and 1.8%, respectively, writes Xu. Tick bites on a child may lead to more than Lyme disease.

The authors reported ticks harboring multiple infectious agents:

  • 1.8% were co-infected by B. burgdorferi and A. phagocytophilum;
  • 1.0% were co-infected by B. burgdorferi and B. microti;
  • 0.4% were co-infected by A. phagocytophilum and B. microti.

Triple co-infections were found in 0.3% of the ticks.

Note: The investigators did not check for other infections, such as Bartonella henselae or Borrelia miyamotoi.

When do tick bites on children occur?

Tick bites on a child occurred most frequently in the Spring and Fall when children are participating in school activities and sports, explains Xu.

According to the authors, 1700 adult ticks displayed two discrete peaks:

  • April – June peak (representing questing activity of the overwintering population)
  • October – December peak (representing large autumnal populations)

Between April and October, 360 nymphs were received, with a clear peak in June.

How effective are tick bite prevention methods?

According to several studies, prevention methods are failing our children. One of the most effective ways of measuring whether tick bite prevention methods are working is to monitor the number of tick bites that involve an engorged tick. [4] This is because ticks typically do not become engorged for at least 24 hours.

READ MORE: The dangers in being bitten by a partially fed tick (not fully engorged), where infection is postulated to occur in less than 6 hours. Have you been bitten by a partially fed tick? 

Unfortunately, Xu and colleagues found that 35.6% of ticks attached to children younger than 9-years-old were engorged.

This is particularly concerning given that an engorged tick increases your chances of developing Lyme disease by 20 times. [5]

Only 12% of children reported performing regular tick checks.

A school-based intervention program, offered to 1,562 elementary students, explored why children are more likely to get a tick bite. [6] The responses indicate a need for ongoing educational efforts on tick bite prevention measures.

Following are the responses to several of the questions:

How often do you check yourself for ticks?

  • 56.8% = sometimes
  • 12.0%  = always
  • 25.8% = usually

Who helps you check for ticks most of the time?

  • 77.8% = grown-up at home
  • 14.6% = themselves
  • 2.0% = grown-up at school checked for ticks
  • 4.4% = did not check at all

“As long as there are no effective measures for controlling tick populations and there is no vaccine available, we rely solely on health education and communication efforts to prevent tick bites and Lyme Borreliosis (LB)” writes Beaujean. [7]

“We call on researchers and funders to prioritize research in the field of public health interventions for tick bites and LB,” he writes, “because, in the words of Benjamin Franklin, ‘an ounce of prevention is worth a pound of cure.’”

UPDATED: June 21, 2021

References:
  1. Bacon RM, Kugeler KJ, Mead PS. Surveillance for Lyme disease–United States, 1992-2006. MMWR Surveill Summ, 57(10), 1-9 (2008).
  2. Marx GE, Spillane M, Beck A, Stein Z, Powell AK, Hinckley AF. Emergency Department Visits for Tick Bites – United States, January 2017-December 2019. MMWR Morb Mortal Wkly Rep. 2021 Apr 30;70(17):612-616. doi: 10.15585/mmwr.mm7017a2. PMID: 33914718; PMCID: PMC8084121.
  3. Xu G, Mather TN, Hollingsworth CS, Rich SM. Passive Surveillance of Ixodes scapularis (Say), Their Biting Activity, and Associated Pathogens in Massachusetts. Vector Borne Zoonotic Dis, 16(8), 520-527 (2016).
  4. Falco RC, Fish D, Piesman J. Duration of tick bites in a Lyme disease-endemic area. Am J Epidemiol, 143(2), 187-192 (1996).
  5. Sood SK. Lyme disease in children. Infect Dis Clin North Am, 29(2), 281-294 (2015).
  6. Shadick NA, Zibit MJ, Nardone E, DeMaria A, Jr., Iannaccone CK, Cui J. A School-Based Intervention to Increase Lyme Disease Preventive Measures Among Elementary School-Aged Children. Vector Borne Zoonotic Dis, 16(8), 507-515 (2016).
  7. Beaujean D, Crutzen R, Kengen C, van Steenbergen J, Ruwaard D. Increase in Ticks and Lyme Borreliosis, Yet Research into Its Prevention on the Wane. Vector Borne Zoonotic Dis, 16(5), 349-351 (2016).

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For more:

Category:

Prevention, research, Ticks

Study Detects Tick-borne Illness in Teens Hospitalized for Depression

https://www.lymedisease.org/hospitalized-teens-lyme-depression/

Study detects tick-borne illness in teens hospitalized for depression

June 10, 2021

Dr. Dan Kinderlehrer

By Daniel A. Kinderlehrer MD

Last month I posted an article on this website describing Diane, a teen-age girl suffering from anorexia nervosa.1 As it turned out, she had Lyme disease and was co-infected with Babesia, Bartonella and Mycoplasma. She responded well to antibiotics and three years later she still has no evidence of an eating disorder.

Dr. Nancy Brown, a colleague, was in my office during one of Diane’s appointments, and I commented to Nancy, “Wouldn’t it be great if we could test a group of people who suffer from anorexia nervosa for tick-borne infections?”

“Well,” she told me, “I’m the medical consultant at a residential treatment center for adolescents with mental health issues. Let’s see if I can get permission to do this.”

We did receive cooperation from the residential center. In addition, IGeneX Laboratory agreed to test a dozen patients free of charge for Lyme, Bartonella, and tick-borne relapsing fever (TBRF). Moleculera Labs also generously agreed to test our patients with the Cunningham Panel. (The Cunningham Panel is a blood test which measures the levels of circulating autoantibodies associated with certain neurologic and psychiatric symptoms.)

Testing depressed adolescents

It was not difficult to get 10 volunteers at the residential center. None had eating disorders, since the center was not equipped to deal with that, but all 10 were diagnosed with DSM-5 Major Depressive Disorder, seven were additionally diagnosed with Generalized Anxiety Disorder, and three had made serious suicide attempts.

With the exception of one subject previously diagnosed with celiac disease, none had a known physical disorder. All of these teens had severe psychological dysfunction requiring intensive residential treatment—they could not hack it at home or go to school.

Here is what we found2:

  • Lyme disease immunoblot was positive by IGeneX criteria for three teens.
  • A more liberal interpretation of the test results consistent with analysis by most Lyme docs, indicated nine had antibodies to Lyme.
  • Antibodies to Bartonella were detected in three, and borderline positive in a fourth.
  • Antibodies to TBRF were detected in four subjects, and borderline positive in another two.
  • Antibodies to Streptococcus were detected in three subjects, and borderline positive in a fourth.
  • The Cunningham Panel was positive in nine of the 10 teens.
In all likelihood, nine of 10 had antibodies to tick-borne infections. And nine of 10 had evidence of autoimmune encephalitis.

Autoimmune encephalitis is the medical term for ‘Brain on Fire’: inflammation in the brain that can result in serious mood, behavioral and cognitive disorders.

PANS/PANDAS

Susan Swedo at the National Institute of Mental Health first described this condition in children who developed neuropsychiatric symptoms shortly after a strep infection. She termed it Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections—PANDAS.3,4

Not long afterwards, it became clear that other microbes besides Streptococcus can trigger autoimmune encephalitis. Hence, the name was broadened to Pediatric Acute-Onset Neuropsychiatric Disorder—PANS.

The microbes that thus far have been shown to trigger PANS include several viruses including Epstein-Barr, the common cold, influenza, and chicken pox as well as Bartonella, Mycoplasma and mold.5-7

There was a recent report out of Italy describing two boys in whom SARS-CoV-2, the virus that causes Covid-19, triggered PANS.8 It is likely, but not definitive at this time, that Borrelia burgdorferi, the Lyme pathogen, also triggers PANS.

In 2013, the PANS collaborative consortium published criteria for the diagnosis of PANS.9 These include the sudden onset of obsessive-compulsive disorder (OCD) or severely restricted food intake, without a known medical disorder that would account for these symptoms. In addition, the case definition requires two of the following seven criteria to make the diagnosis:

  • Anxiety
  • Emotional lability (mood swings) or depression
  • Irritability, aggression and/or oppositional behavior
  • Behavioral (developmental) regression
  • Sudden deterioration in school performance
  • Motor or sensory abnormalities including tics and involuntary movements
  • Somatic signs and symptoms—like sleep disturbances and bed-wetting

It is important to have clear diagnostic criteria so that researchers studying this condition are always studying the same population of subjects, but not all kids with autoimmune encephalitis will fulfill these criteria. In particular, most of my patients do not have an acute—i.e, sudden—onset of their symptoms. Instead, the onset may be stuttering or slow.

An epidemic of mental illness in adolescents?

According to the National Institutes of Mental Health, nearly one-third of all adolescents ages 13 to 18 will experience an anxiety disorder, and 8% of those will become severely impaired.10

The NIMH also reported that the prevalence of major depressive disorder in adolescents in 2017 was 13.3%, with nearly three-quarters of those becoming severely impaired.11 Suicide has replaced homicide as the second most common cause of death for teenagers ages 10 to 19 in the United States.12

In other words, we have an epidemic of mental illness in adolescents.

Our investigation was small. Ten adolescents picked at random with mental illness severe enough that they required institutionalization—nine of them had evidence of tick-borne infections and nine had evidence of autoimmune encephalitis.

Clearly there is a need for more investigation, but I suspect that many of the teens afflicted with mental illness in the U.S. are suffering from brains on fire. Their illness may present as emotional, but the cause may be organic. In the next installment I will discuss the diagnosis and treatment of PANS.

Dr. Daniel Kinderlehrer is an internal medicine physician with a private practice in Denver, Colorado, devoted to treating patients with tick-borne illness. He is the author of  Recovery From Lyme Disease: The Integrative Medicine Guide to the Diagnosis and Treatment of Tick-Borne Illness.

References

  1. https://www.lymedisease.org/lyme-bartonella-eating-disorders/#:~:text=An%20infection%20can%20cause%20an,but%20also%20trigger%20anorexia%20nervosa.
  2. Kinderlehrer DA, Brown N. Microbial Induced Autoimmune Inflammation as a Cause of Mental Illness in Adolescents. Global J Med Res. 2021;21(1):1-13.
  3. Swedo SE, Leonard HL, Kiessling LS. Speculations on Antineuronal Antibody-Mediated Neuropsychiatric Disorders of Childhood. Pediatrics. 1994Feb1; 93(2):323–6. 39.
  4. Swedo SE, Seidlitz J, Kovacevic M, Latimer ME, Hommer R, Lougee L, Grant P. Clinical presentation of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections in research and community settings. J Child Adolesc Psychopharmacol. 2015 Feb; 25(1):26-30.
  5. Breitschwerdt EB, Greenberg R, Maggi RG, Mozayeni BR, Lewis A, Bradley JM. Bartonella henselae Bloodstream Infection in a Boy With Pediatric Acute-Onset Neuropsychiatric Syndrome. J Cent Nerv Syst Dis. 2019Mar18; 11. DOI: 10.1177/1179573519832014.
  6. Frankovich J, Thienemann M, Rana S, Chang K. Five Youth with Pediatric Acute-Onset Neuropsychiatric Syndrome of Differing Etiologies. J Child Adolesc Psychopharmacol. 2015; 25(1):31–7. DOI: 10.1089/cap.2014.0056.
  7. Tisi G, Marzolini M, Biffi G. Pediatric acute onset neuropsychiatric syndrome associated with Epstein–Barr infection in child with Noonan syndrome. Europ Psychiatry. 2017; 41(Supplement): S456. DOI: 10.1016/j.eurpsy.2017. 01.492.
  8. Pavone P, Ceccarelli M, Marino S. SARS-CoV-2 related paediatric acute-onset neuropsychiatric syndrome. Lancet. 2021;5:e19-21.
  9. Chang K, Frankovich J, Cooperstock M, Cunningham MW, Latimer ME, Murphy TK, Pasternack M, Thienemann M, Williams K, Walter J, Swedo SE, and from the PANS collaborative consortium. Clinical Evaluation of Youth with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS): Recommendations from the 2013 PANS Consensus Conference. J Child Adolesc Psychopharmacol. 2015; 25(1):3–13.
  10. https://www.nimh.nih.gov/health/statistics/any-anxiety-disorder#:~:text=An%20estimated%2031.9%25%20of%20adolescents,than%20for%20males%20(26.1%25).
  11. https://www.nimh.nih.gov/health/statistics/major-depression
  12. Curtin SC, Heron M. Death rates due to suicide and homicide among persons aged 10–24: United States, 2000–2017. NCHS Data Brief. 2019Oct;352.

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**Comment**

Very, very important work being done here with a dire need for more. Unfortunately researchers are choosing to go with the more popular and lucrative work surrounding “climate change,” despite the fact credible, independent work has been done disproving it of having anything to do with tick and disease proliferation.

Few understand the dark underpinnings of our public health ‘authorities’ and the research they pay for and control and the fact they own patents on everything from the organism, to the tests that reveal it, to the vaccines against it.

For more:

Category:

Lyme, Psychological Aspects, research