Changes to CDC’s Lyme case definition add complexity, case undercounting

In January 2022, the U.S. Council of State and Territorial Epidemiologists (CSTE) published a revision to its 2017 Lyme disease case definition. This definition will soon be integrated into the physician reporting form that is used by the Centers for Disease Control (CDC) to classify, count, and track Lyme disease cases consistently across the country.

The annual Lyme disease case count is an important metric for allocating government research dollars and staff resources. With about 476,000 new cases a year and growing, the CDC’s previous case definition and reporting requirement was already burdensome for both physicians and local health departments. (In 2016, Massachusetts modified the CDC reporting criteria because of this. In 2008, New Jersey wrote about the burdens of the surveillance criteria here.) Unfortunately, the 2022 revision and the public health burden of the COVID-19 pandemic may only make this situation worse.

The two biggest changes to the definition are the inclusion of Borrelia mayonii, a newly discovered Borrelia burgdorferi family memberin the Lyme case count, and the option for physicians to use a cheaper, simpler test in the second part of the two-tiered testing protocol. Despite a few positive changes to the 2022 revision, the new definition doesn’t fix some of the fundamental flaws of the old definition, and this could lead to the undercounting and misdiagnosis of truly ill Lyme patients.

Here is a summary of major changes and possible impacts:

Borrelia mayonii cases will be counted…sort of. 

Borrelia mayonii is a newly discovered member of the Borrelia burgdorferi sensu lato genospecies that has also been shown to cause Lyme disease. It is primarily found in the upper midwestern United States. Like B. burgdorferiB. mayonii causes fever, headache, rash, and neck pain in the days after infection and can cause arthritis after a few weeks of illness. It can also cause nausea and vomiting; large, widespread rashes; and a higher concentration of bacteria in the blood than B. burgdorferi. Unfortunately, many of these cases will be overlooked because the traditional Lyme tests only pick up about half the B. mayonii cases, and there are currently no FDA-approved B. mayonii tests on the market. (Mayo clinic, IGeneX, and Medical Diagnostics Lab, among others, offer in-house tests.) 

In the two-tiered testing process, the western blot can now be replaced with a cheaper, sometimes less informative, enzyme immunoassay (EIA) test.

Western blots, which display an array of individual antibody bands for both present (IgM) and past (IgG) Lyme infections, are more expensive and harder to interpret than EIA tests. But doing away with the western blots eliminates useful clinical data for treating physicians. Some of the antibody protein bands can shed light on neurologic, arthritic, or late-stage manifestations of the disease. In addition, the revision states that only the IgG “late stage” antibody EIA tests need to be used, which doesn’t acknowledge the dormant and relapsing nature of Borrelia infections. The new definition also requires that the EIA tests are FDA approved, which will discourage the use of accurate, validated in-house tests developed at universities and specialty labs. (FDA approval is only required for tests that are resold to other commercial labs. )

Case reporting has been complicated with geographical requirements that may lead to underreporting.

Two case reporting decision trees are now required for low- and high-incidence case areas, overlayed with a complex matrix of confirmatory/presumptive evidence and suspect/probable/confirmed classifications. What’s more, the determination of whether a person lives in a low- or high-incidence area is based on CDC data that’s typically a year or more old. The complexity of this process will mostly likely lead to underreporting by our already overloaded health-care professionals, and it begs the question—is it really necessary? Lyme disease cases have been detected in all 50 states and the District of Columbia, and people are often infected during travel. Why not make reporting simple up front, and let epidemiologists, data from electronic medical records, and advanced informatics software on the backend of the process analyze the disease spread?

On a positive note, some changes to the new case definition are good. There’s a deemphasis on Lyme arthritis symptoms and the inclusion of other important symptoms, such as secondary rashes and neurological symptoms like headaches, fatigue, stiff necks, and nerve tingling. And kudos to the CDC for highlighting that the surveillance case definitions are not to be used by health-care providers for making clinical diagnoses or treatment decisions.

But overall, the fundamental problem with this new case definition is that the CSTE and CDC have added burdensome complexity on top of an already archaic process, without trying to streamline it and leverage new sources of data and analytical tools to make the case count more accurate. 

If there is light at the end the end of the tunnel, it is that in 2020 the CDC launched a Data Modernization Initiative, in pursuit of a disease tracking system that will bring more real-time public health data to our decision makers. We hope that Lyme disease will be included in that system.

REFERENCES:

CDC’s 2022 Lyme Case Definition:
https://ndc.services.cdc.gov/case-definitions/lyme-disease-2022/

CDC’s 2017 Lyme Case Definition:
https://ndc.services.cdc.gov/case-definitions/lyme-disease-2017/

A comparison of the 2022 and 2017 Lyme case definition:
https://www.documentcloud.org/documents/22020656-2017-vs-2022-lyme-case-definition

2009 HHS Lyme disease case report (not updated yet):
https://www.cdc.gov/lyme/resources/lymediseasecasereportform.pdf

FDA approval of EIA tests:
https://www.fda.gov/news-events/press-announcements/fda-clears-new-indications-existing-lyme-disease-tests-may-help-streamline-diagnoses

Effect of electronic laboratory reporting on the burden of lyme disease surveillance–New Jersey, 2001-2006:
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5702a4.htm

CDC “Due to the coronavirus disease 2019 (COVID-19) pandemic, [Lyme disease] data from some jurisdictions may be incomplete.”
https://www.cdc.gov/lyme/datasurveillance/recent-surveillance-data

Some good news for the Lyme disease community

This week Invisible International shines a light on recent progress in the Lyme disease world with 10 reasons to be thankful for the patient advocates and researchers dedicated to reducing the suffering of those with Lyme and other tick-borne diseases.

It’s easy to dwell on the negative with Lyme disease. Forty-seven years after discovery of the first case cluster in Lyme, Conn., there are still no reliable tests or effective vaccines on the market. Among those patients who are treated promptly, about a third go on to suffer from persistent symptoms.

But it’s important to keep things in perspective. Incremental progress is being made, albeit slowly. There’s a growing acknowledgment of the magnitude of the Lyme problem in the medical system, the government, and the media. New diagnostics, vaccines, and therapeutics are finally working their way out of basic research labs and into clinical validation studies. Invisible’s mission is to accelerate progress on all these fronts.

Here are 10 signs of progress for the Lyme disease community:

⁕ The CDC ups the annual Lyme disease cases to 476,000
After analyzing medical insurance claims data on Lyme disease in 2021, the U.S. Centers for Disease Control and Prevention upped their public-facing estimate of 300,000 annual cases to 476,000 per year. “Our results underscore the need for accurate diagnosis and improved prevention,” says the CDC. This updated estimate provides a larger “market size” that may incentivize commercial interests to develop better diagnostics, vaccines, and therapeutics.

⁕ New WHO ICD-11 Lyme disease diagnostics codes
The World Health Organization (WHO) added 15 new medical diagnostic codes for Lyme disease (aka borreliosis) complications, effective on January 1, 2022. Over time, these codes will provide patients with more avenues for medical insurance reimbursement and will enable researchers to better track and analyze Lyme disease complications, treatments, and outcomes. On the international front, the European Union is now requiring mandatory reporting of neuroborreliosis, a move that will help with research funding, prevention, and disease tracking.

⁕ More patient participation in the U.S. research agenda
Patients’ voices are starting to be heard. Since 2017, patient advocates in the HHS Tick-Borne Disease Working Group (TBDWG) have been effective in educating Congress and researchers on the urgent need for better diagnostics and treatments. MyLymeData, a patient information database managed by LymeDisease.org, has quantified time-to-diagnosis, common symptoms, and treatment outcomes, providing a big-data window into the needs of patients. Lastly, the Center for Lyme Action, founded in 2019, organized educational sessions within the US federal government to facilitate the passage of a new appropriations bill that nearly doubled the federal funding for Lyme Disease to $108M in FY21.

⁕ Strong evidence of active Lyme infections after treatment
A recent spate of research studies show that Lyme disease symptoms can persist after recommended treatment protocols, challenging the widely held belief that Lyme disease can always be cured with a short course of antibiotics. Acknowledgement that chronic Lyme is a real medical condition is the first step in justifying the development of more effective treatments for both early and late stages of the disease. A summary of this evidence can be found in here.

⁕ Recognition of the dangers of mixed tick-borne infections
When several university labs started gene sequencing and cataloging all the disease-causing microbes inside ticks, they discovered that polymicrobial infections transmitted through a single tick bite are far more common than previously thought. In the U.S., there are at least 18 disease-causing bacteria and viruses carried by ticks. And new studies have found that the standard U.S. Lyme testing doesn’t detect the newly recognized Lyme-like bacterial species spreading in the West and Midwest. This new information is another reason to design better screening tests and treatment guidelines for mixed tick-borne diseases. Read more here, here, and here.

⁕ Invisible International’s free medical education courses on tick- and vector-borne diseases
Invisible International’s physician education platform is the world’s first accredited curriculum focused on tick- and vector-borne diseases. These virtual courses are available at no cost to medical professionals and patients. Taught by leading experts in tick/vector-borne diseases, this platform is accelerating the movement of the latest diagnostics and treatment advice to the frontlines of medical care. New courses are added monthly and are accredited by the American Academy of Family Physicians for AMA credit. This effort is funded by the Montecalvo Family Foundation. To help Invisible integrate these courses into medical school curriculums across the U.S. and abroad, click here.

⁕ New therapeutic/treatment options on the horizon
A relatively new technology called “high throughput drug screening” enables researchers to place Lyme bacteria in an array of tiny wells and expose them to thousands of FDA-approved chemical compounds and drugs to see which ones are best at killing the microbes. The best and safest drug candidates are then retested in live mice, and, eventually, in humans. This process saves the time and money associated with large human clinical trials and speeds up the regulatory approval process. 
 
⁕ The LymeX Diagnostics Prize
The weak link in reducing the public health burden of tick-borne illnesses is the lack of fast, cheap, and accurate diagnostics. Lyme treatment is often delayed because the screening tests aren’t reliable in the first month after infection and not everyone produces or notices a bullseye rash. In the later stages of the disease, antibody testing can be unreliable in the sickest patients, those whose antibody production may be hobbled by concurrent infections or a weak immune system. LymeX, a public-private partnership, will be offering large prizes to incentivize the development of better Lyme diagnostics. This effort is part of the $25 million public-private partnership between the  U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation. Invisible is joining the field-wide effort to support new diagnostic development by organizing a “Tick-borne Illness Diagnostics Development Incubator”, a yearlong collaborative forum designed to help bring these diagnostics solutions to the market faster. This effort is funded by the Lovell Family Healthcare Foundation.

⁕ Studies revealing the suicide/mental health risks of Lyme and co-infections
In a large retrospective study of nearly 7 million subjects, U.S. and Danish researchers report that patients who received a hospital diagnosis of Lyme disease—inpatient, outpatient, or at the ER—had a 28 percent higher rate of mental disorders and were twice as likely to have attempted suicide post-infection, compared to individuals without the diagnosis. Studies like these show that undertreated Lyme disease can lead to serious mental illness, and that it should be a differential diagnosis for certain patients with sudden-onset depression, suicidal thoughts, and other mental disorders. Read more here, here, and here.

⁕ A breakthrough in public awareness of the tick-borne disease problem
A growing number of mainstream journalists, writers, and professionals have gone public with their personal stories on the emotional, financial, and societal toll of tick-borne illnesses. This is an essential step in mitigating the social stigma, medical gaslighting, and myth that Lyme disease is easy to diagnose, treat, and cure. Notable new additions to this genre include “Chronic,” “The Invisible Kingdom,” “The Deep Places,” “What Lurks in the Woods,” and “Bitten” (my book). Invisible’s “Storytelling for Change” initiative aims to continue this momentum with a team of clinicians, researchers, and writers collaborating to produce mass media stories that explain emerging science and promote understanding of the suffering and social injustices laid on families dealing with invisible illness.

Help Invisible International do more to create positive change and scientific advancement for the Lyme disease community. Make a gift today.

For weekly updates on all things related to Lyme disease and other invisible vector-borne diseases, sign up for Invisible International’s newsletter here: https://invisible.international/newsletter/

Tulane researcher asks, “Could chronic Lyme contribute to Alzheimer’s dementia?”

In 2019, the late-great-science-writer Sharon Begley wrote an insightful article, “The maddening saga of how an Alzheimer’s ‘cabal’ thwarted progress toward a cure for decades.”

Begley’s reporting described how a powerful group of researchers became fixated on one theory of Alzheimer’s causation at the expense of all others. Their hypothesis: that Alzheimer’s cognitive decline was caused by neuron-killing, beta-amyloid protein clumps in the brain, and that if you dissolved the clumps, the disease process would stop.

As this theory hit a brick wall, Begley showed how the actions of the cabal harmed patients: “…for decades, believers in the dominant hypothesis suppressed research on alternative ideas: They influenced what studies got published in top journals, which scientists got funded, who got tenure, and who got speaking slots at reputation-buffing scientific conferences.”

Decades later, with no cure or effective drugs for Alzheimer’s dementia, some researchers are gathering evidence on a different causation theory — that dementia could be triggered by any number of chronic infectious diseases, and that amyloid plaques are a byproduct of an active infection, not the cause.

One of these researchers is Monica Embers, PhD, an associate professor of microbiology and immunology at the Tulane National Primate Research Center. She’s also the leading expert in identifying treatments that can eradicate Lyme bacteria infections in nonhuman primates, our closest mammalian relatives. In her new continuing medical education course, “Chronic Infection and the Etiology of Dementia,” she lays out the evidence that the Lyme bacteria could be one possible cause of dementia.

Her theory is this: When pathogens like the Lyme bacteria sneak past the blood-brain barrier, the immune system doesn’t allow protective killer cells from the entering the inflexible brain cavity, because resulting brain inflammation and swelling could lead to death. Instead, it encapsulates invading microbes with protein clumps, called beta-amyloid plaques or Lewy bodies, to stop the infection. As a person ages, the bodily processes that clean up this “brain gunk” slows, resulting in protein accumulation that impedes brain signaling and kills neurons.

In her 31-minute course, Dr. Embers describes the clinical symptoms of Alzheimer’s and Lewy body dementia, the impact on public health, genetic risks, and the list of infections associated with dementia-like symptoms.

The course also reviews a well-documented case study about a 54-year-old woman who was treated for the Lyme bacteria (Borrelia burgdorferi), developed dementia, then died 15 years after the initial infection. After death, B. burgdorferi was identified by PCR (DNA detection) in her brain and central nervous system (CNS) tissues, and by immunofluorescent staining of the bacteria in the spinal cord. (For more, read this peer-reviewed study.)

Dr. Embers and her study’s co-authors conclude, “These studies offer proof of the principle that persistent infection with the Lyme disease spirochete may have lingering consequences on the CNS. Published in postmortem brain autopsy images and extensive pathology tests are a compelling reason to pursue this line of scientific inquiry.”

You can watch this free CME here

To help us launch our CME curriculum in hospitals and medical schools, donate here.

Invisible International’s Education Platform for Tick-borne Illness is funded by the Montecalvo Family Foundation. This platform currently offers 24 free, online Continuing Medical Education (CME) courses on the diagnostics, epidemiology, immunology, symptoms, and treatment of Lyme disease, Bartonellosis, and other vector-borne diseases. 

Update on the Tick-borne Illness Diagnostics Incubator

Invisible International is supporting six teams in its “Tick-borne Illness Diagnostics Development Incubator,” a yearlong collaborative forum designed to help bring better diagnostics solutions to the market faster. This month, organized teams of researchers, diagnostics companies, patients, government representatives, and industry funders have been holding regular meetings to discuss needs, regulatory/technology roadblocks, and marketing strategies. The diagnostics companies participating include R.E.D. Laboratories, Flightpath Biosciences, Galaxy Diagnostics, TickPlex/Tezted, IGeneX, and LabCorp.

One of the new players in this space is a Belgium-based company, R.E.D. Laboratories. Their novel “Phelix Phage” Borrelia detection method (Patent WO2018083491A1) was co-discovered by Jinyu Shan, PhD, University of Leicester; Professor Martha Clokie, University of Leicester; and Dr. Louis Teulières, Phelix R&D. This test can used on blood, urine, biopsies, or ticks to detect the presence of specific phages, spider-like viruses that parasitically prey on targeted Borrelia bacteria. The phages are transmitted with Borrelia during a tick bite, and they can only survive if their bacterial hosts are alive. Detecting these specialized phages in blood or urine provides direct evidence of active Borrelia infections in both early- and late-stage patients. And preliminary studies are promising, showing a >90% sensitivity and 100% specificity, a huge improvement over the two-tiered testing used today.

Thus far, the lab has developed diagnostics for the Borrelia sensu lato group (the 18 Borrelia species that cause Lyme borreliosis), the relapsing fever Borrelia group, Borrelia miyamotoi, (a recently discovered, genetically distinct member of the relapsing fever group), and a broad range of rickettsias. They’re also using this approach to develop tests for other tick-borne pathogens.

Tanja Mijatovic, PhD, the Chief Scientific Officer of R.E.D. Laboratories, said, “After more than two years of using the Phelix Phage Borrelia test, we’ve discovered that far more patients (primarily late stage) have tested positive for the relapsing fever group (B. miyamotoi, B. hermsii, etc.) than the Borrelia sensu lato group.”

This raises an interesting scientific question — might patients with persistent Lyme symptoms have active, undetected infections caused by microbes that no one is looking for?

R.E.D. Labs is currently looking for partnerships with health-care facilities and practitioners involved in infectious diseases, to help challenge and validate their tests. Inquiries can be directed to Dr. Mijatovic: tmijatovic@redlabs.be

In future weeks, Invisible will profile other incubator teams and participants.

***
Invisible’s incubator is designed to complement the
LymeX Tick-Borne Disease Innovation Accelerator, which will be offering research prizes for the development for better early Lyme diagnostics over three phases. [LymeX is funded with $25 million from the Steven & Alexandra Cohen Foundation and co-managed with the U.S. Department of Health and Human Services (HHS).] The Invisible Incubator is helping diagnostic companies gain a competitive edge in this competition, by making it easy to engage with clinical, lab, and research collaborators, and by participating in forums where past and emerging technologies will be discussed.

This incubator program is a component of Invisible’s Lovell Innovation Platform, funded by a trailblazing donation by Mark and Eileen Lovell. Thanks to their generous support, Invisible International is delivering programs that will change the landscape of tick-borne illness and other invisible illnesses through community action, education, and research.

What you need to know about the new Lyme ICD-11 diagnostic codes

The World Health Organization (WHO) has added 15 new medical diagnostic codes for Lyme disease, which replaced four older codes and officially went into effect on January 1, 2022. Over time, these codes will provide patients with more avenues for medical insurance reimbursement and enable researchers to better track and analyze Lyme disease complications, treatments, and outcomes.

The International Classification of Diseases, 11th Edition (ICD-11), replaces the ICD-10 as the foundation for identifying health trends and statistics worldwide. It is also the international standard for reporting mortality, morbidity, and other conditions affecting health.

While the WHO recognized Lyme borreliosis to be a “disease of consequence” in the 1990s, there were only four Lyme ICD codes until now (acute Lyme, and Lyme arthritis, meningitis, and polyneuropathy). These codes didn’t recognize chronic Lyme or many of the serious, potentially fatal complications of the disease that have come to light over the last three decades. This resulted in medical insurance denials for seriously ill Lyme patients and the loss of health data that could be used in evaluating diagnoses and treatments.

What does this mean for Lyme disease patients today? Well, it may take some time for the new codes to be adopted by medical insurers, but the incorporation of them into electronic health records systems will enable researchers to better analyze Lyme patient symptoms, treatments, and outcomes.

In the interim, Lyme patients can learn more about these codes (see the list below) and listen to an interview with Jenna Luche-Thayer, MIA, Founder and Director of the Ad Hoc Committee for Health Equity in ICD-11 Borreliosis Codes, to understand how they will improve Lyme patients care and medical reimbursements. The podcast is hosted by Kristina Bauer, Director of Texas Lyme Alliance and an advocate for congenital and pediatric Lyme treatment.

Watch here:


New ICD-11 Lyme Codes

Lyme borreliosis (1C1G)

  • Early cutaneous Lyme borreliosis, Stage 1 Lyme disease (1C1G.0)
  • Disseminated Lyme borreliosis (1C1G.1)
  • Lyme neuroborreliosis, Myelitis associated with Lyme disease (1C1G.10)
  • Lyme carditis (1C1G.11)
  • Ophthalmic Lyme borreliosis (1C1G.12)
  • Lyme arthritis (1C1G.13)
  • Late cutaneous Lyme borreliosis (1C1G.14)
  • Other specified disseminated Lyme borreliosis (1C1G.1Y)
  • Disseminated Lyme borreliosis, Stage 2 (1C1G.1Z)

    Other
  • Dementia due to other specified diseases classified elsewhere: Dementia due to Lyme Disease (6D85.Y)
  • Infectious panuveitis: Infectious panuveitis in Lyme disease (9C20.1)
  • Infectious intermediate Chorioditis: Infectious intermediate uveitis in Lyme disease (9B66.1)
  • Other specified white matter disorders due to infections: Central Nervous System demyelination due to Lyme borreliosis (8A45.0Y)
  • In addition, congenital Lyme can be coded with “KA6Y Other specified infections of the fetus or newborn” and “XN13C Borrelia Burgdorferi.”

Do I Have Lyme Disease? A Physician Offers Advice.

Christine Green, MD, is a Stanford-trained, board-certified family medicine physician with 30 years of experience treating patients with tick-borne illness. In this Q&A, she discusses common symptoms and the diagnostic process for Lyme disease and other tick-borne diseases.

Q: I’m achy and tired all the time. Could I have Lyme disease?

The answer is yes. When a patient comes into my clinic for the first time, I take down their clinical history. If I suspect tick-borne disease, I ask if they’ve been exposed to ticks or tick habitats. Have they observed any rashes? The typical Lyme rash expands and is ring-like, usually not itchy or painful. If it’s under a person’s hairline, between the toes, or on the back of the body, it may not be noticed. At least 21% of Lyme patients, and probably more than 50%, never see a tick or a rash.

Early Lyme patients present with flu-like symptoms. Tick bites and resulting symptoms often occur in the summer, but in my California practice, Lyme season may overlap with the fall/winter flu season, confusing the diagnostic picture.

Next, I do a complete physical exam, with an emphasis on neurological deficits, such as loss of balance, tremors, facial asymmetry (Bell’s Palsy), and asymmetric reflexes. Then, I ask about the progression of their symptoms over time. In the first few months of Lyme disease, patients often experience malaise, fatigue, mild-to-severe headaches, nerve pain or tingling in the hands or feet, all in a relapsing-remitting course. In other words, the symptoms wax and wane.

If Lyme is diagnosed four or more months after symptom onset, the picture of the disease is different and variable. The longer between infection and diagnosis, the higher likelihood that more bodily systems have been invaded. Late-stage patients tend to have peripheral nerve symptoms that come and go, and symptoms that migrate to joints, muscles and/or nerves. Most patients with late Lyme have encephalopathy, inflammation of the brain that reduces blood supply in some areas. It can manifest as sleep problems, memory issues, word-recall problems, or difficulty reading or carrying out executive functions, the mental processes that enable us to plan, focus, remember instructions, and juggle multiple activities. For instance, a person who organizes large events might find that they have trouble completing and sequencing tasks. Things that used to take minutes, take hours.

Patients can also experience cardiac symptoms, including irregular heartbeats, chest pain, or dizziness. These patients often come in misdiagnosed with old age, depression, anxiety, or hypochondriasis (preoccupation with an imagined illness). Another presentation of this disease is chronic pain. The pain can be widespread and migrate around the body. These patients often come in with a diagnosis of fibromyalgia or new onset migraine headache.

Q: What’s the best test for diagnosing Lyme disease?

First and foremost, Lyme disease, as with any disease, should be diagnosed based on a clinical history and physical exam, not by test results alone. It’s important to note that the complex, conservative two-tiered testing criteria for “CDC positive cases” was developed for disease-tracking only, and it shouldn’t be used by physicians as the sole criteria for diagnosis or denying treatment to patients. What’s more, not all Lyme tests are created equal. The major labs typically look for only one strain of Lyme bacteria, the B31 strain of Borrelia burgdorferi. I prefer using specialized labs that test for multiple Lyme strains. Three of the labs I use are MDL, Galaxy, and Igenex.

One tick can inject multiple species of disease-causing microbes in single blood meal, so, based on symptoms, I sometimes test for other tick-borne infections. If a patient has night sweats, shortness of breath, stabbing chest pains, or autonomic symptoms (dizziness, nausea, vertigo, flushing), I’ll test for babesia, a malaria-like red blood cell infection. For a pinprick rash on the extremities and/or severe illness, I’ll test for spotted fever. Bartonellosis can present in many ways, including neuropathy, or neuropsychiatric symptoms, such as panic attacks, rages, psychosis, and obsessive-compulsive disorders.

 Q: Once diagnosed, how should you treat Lyme disease?

Research over the last three decades suggests that Lyme bacteria have multiple ways of evading the human immune system and that treating acute Lyme with 21 days of antibiotics fails approximately a third of patients. For that reason, I treat in two phases. For early Lyme, I treat with four weeks of doxycycline, amoxicillin, or cefuroxime antibiotics. I follow this up with four more weeks of drugs that prevent and eradicate “persister” forms of the bacteria. The persisters are drug-tolerant and can revert to an active infection once the antibiotics are stopped.

I treat late Lyme patients with severe degenerative neurologic or rheumatologic cases aggressively. As noted above, the very sick patients frequently have a mixture of tick-borne infections. For these patients, I choose a combination of oral or, when needed, intravenous antibiotics that target the pathogens known to be present.

 Q: Can you cure chronic Lyme disease?

In my practice, I’ve helped many of my tick-borne disease patients return to full health. Every patient is unique, with different genetics, co-morbidities, and co-infections. To me, the important thing is to evaluate clinical response and not to cut off treatment at some arbitrary end point. I assess symptoms at the beginning of each visit, then treat until symptoms improve or resolve. For any patient who is ill for an extended time, after the illness is controlled, I initiate rehabilitation protocols to help the person feel normal again. A patient must become fit to fully recover from a protracted state of ill health.

——

For a checklist of common Lyme disease symptoms or to find an experienced tick-borne disease physician, visit the Lymedisease.org website.

To learn more about diagnosing and treating vector-borne diseases, watch Invisible International’s online, evidence-based physician medical education courses.

Free CME course on neurological infections of Bartonella

Invisible International has released a new course on neurological and neuropsychiatric manifestations of Bartonella, a family of stealth bacteria best known for causing cat scratch disease and trench fever. This course discusses neurological presentations, diagnostic strategies, and emerging evidence showing a possible association between Bartonella and schizophrenia.

In the last few years, there has been a growing body of knowledge on the Bartonella family of bacteria. In this course, Edward Breitschwerdt, DVM, a leading expert on Bartonellosis in mammals, delivers the latest research and paints a disturbing picture of what can go wrong if a neurological Bartonella infection runs rampant in an immunocompromised or immunocompetent patient.

In humans, a Bartonella henselae infection (aka cat scratch disease) typically starts with a fever and swelling or lesions at the wound site, appearing three to 10 days after a bite or scratch from an infected mammal. Swollen lymph nodes show up one to two weeks later, and half of patients report headaches, lack of appetite, weight loss, vomiting, and, occasionally, a sore throat.

Five to 20 percent of those infected with cat scratch disease (i.e. an acute Bartonella henselae infection) exhibit severe symptoms, according to national insurance claims data published in the July 2020 issue of Emerging Infectious Diseases. These complications can involve the eyes, heart, liver, spleen, skin, musculoskeletal system and, the focus of this course, the nervous system.

Dr. Breitschwerdt believes that Bartonella is an underdiagnosed driver of many neurologic and neuropsychiatric diseases of unknown cause. He calls his fellow veterinarian workers “the canaries in the coal mine” for this emerging threat, citing a study that showed that 28% of the study’s veterinarian worker subjects were infected with the bacteria, based upon the detection of Bartonella DNA in their blood. He also reminds physicians to ask sick patients about their exposure to animals, bites and scratches, flea infestations and exposures to other known or suspected vectors for Bartonella transmission. Bartonella often occurs in families, infecting both pets and their human companions.

One of the most intriguing parts of this new course is the discussion of a recent study generated with his University of North Carolina research collaborators. The study found that people with schizophrenia were more likely than healthy volunteers to have Bartonella DNA in their bloodstream. In this study, 11 of 17 schizophrenia patients (65 percent, compared with 13 healthy controls) tested positive for Bartonella using the new “droplet digital enrichment blood culture PCR test” that his research team developed. Because this study was halted early due to the COVID-19 pandemic, a larger study is being planned at this time.

Edward Breitschwerdt, DVM, the course’s author, is the Melanie S. Steele professor of medicine and infectious diseases at the North Carolina State University College of Veterinary Medicine. He is also an adjunct professor of medicine at Duke University Medical Center and a diplomate in the American College of Veterinary Internal Medicine (ACVIM). As a leading expert on bartonellosis, he directs the Intracellular Pathogens Research Laboratory in the Institute for Comparative Medicine and co-directs the Vector Borne Diseases Diagnostic Laboratory at NCSU. This course is currently in review for CME credit by the American Academy of Family Physicians.

This project is funded by the Montecalvo Platform for Tick-Borne Illness Education, through Invisible International, a 501(c)(3) nonprofit foundation dedicated to reducing the suffering associated with invisible illnesses and social marginalization through innovation, education, and data-driven change projects. You can sign up to receive news and updates at: https://invisible.international/mission

Links to Bartonella courses: History of a hidden pandemic, Vectors and other modes of transmission, Reservoir hosts: Bats, cats, dogs, mice and men, Comparative infectious disease causation, Disease expression and host immunity, and Diagnosis of Bartonella species infections.

A historic case study on chronic Lyme disease

In this free medical education course, Kenneth Liegner, MD, a New York-based internist who has been treating tick-borne disease patients since 1988, discusses one of the earliest documented cases of chronic Lyme disease.

In 1987, Vicki Logan, a 39-year-old pediatric intensive-care-unit nurse from Goldens Bridge, New York, began suffering from headaches, fevers, fatigue, progressive paralysis, cognitive difficulties, and memory loss. Her doctors couldn’t figure out what was wrong, so she was left to cope with this debilitating chronic illness on her own.

Two years later, Dr. Kenneth Liegner of Pawling, NY, decided to take on Logan as a patient, in what may be one of the earliest and most scientifically validated case of chronic Lyme disease on record.

First, he tested Logan for Lyme disease, and all the tests came back negative. She had no history of tick bite or rash, but he knew that Logan lived in a hot spot for Lyme disease, so he decided to presumptively treat her with intravenous antibiotics. After three weeks of IV cefotaxime and four months of oral minocycline, he saw no improvement in her condition.

This started a long diagnostic process to figure out what was wrong with Logan. Along the way, Dr. Liegner consulted with experts in rheumatology, immunology, and neurology. Repeatedly he sent her cerebral spinal fluid (CSF) to pathologists, all of whom observed no bacterial infections. Finally, he sent a spinal fluid sample to the Centers for Disease Control (CDC), and, when the fluid was placed in a special BSK-II growth medium, spirochetes began multiplying. On Jan. 14, 1994, the CDC experts verified that this was the first “gold standard” proof that the Lyme bacterium, Borrelia burgdorferi, can survive in a patient after months of IV and oral antibiotic treatments.

Because Logan’s Lyme disease case was so well documented, her post-mortem tissues have been used in numerous research studies. These studies have shown that the Lyme bacteria had invaded her heart, liver, and brain. A more recent study suggests that Borrelia burgdorferi is able to withstand the administration of antibiotics by forming biofilm structures, protective clusters of microbes, polysaccharides, proteins, lipids, and DNA, around itself.

You can watch a first-hand account of this fascinating medical mystery story here.

***

This course is part of Invisible International’s Education Platform for Tick-borne Illness, funded by the Montecalvo Family Foundation. It currently offers more than 22 free, online Continuing Medical Education (CME) courses on the diagnostics, epidemiology, immunology, symptoms, and treatment of Lyme disease, Bartonellosis, and other tick-borne diseases.

Invisible International, a 501(c)(3) nonprofit organization, is committed to alleviating the suffering caused by invisible illnesses, through education, research, and community empowerment.

You can sign up to receive news and updates at https://invisible.international/mission

Other related courses: Borrelia persistence “Bench to Bedside” E-Colloquium, Antibiotic efficacy for treatment of Lyme disease, The impact of immune responses on diagnosis and treatment of Lyme disease

Lyme testing: The good, the bad, and the ugly

In the free medical education course, “Serologic testing in Lyme disease,” Elizabeth L. Maloney, MD, a Minnesota family physician and tick-borne disease educator, reviews published studies that evaluate current Lyme disease tests and discusses how these tests should be used in diagnosing patients.

I think many experts would agree with me on this point: The United States’ Lyme disease testing strategy is confusing, time consuming, subject to human error, and urgently in need of a technology upgrade. The quickest way to get up to speed on the good, the bad, and the ugly of Lyme testing is to watch Dr. Elizabeth Maloney’s accredited medical education course on the topic. With clarity and precision, Dr. Maloney explains the specificity, sensitivity, and accuracy of the most widely used Lyme tests, discussing how these tests should be used in a clinical setting and illuminating areas for improvement for the next generation of diagnostic approaches.

The underlying message of the lecture is that we can do better, and this is the reason Invisible International is launching a “Tick-borne Illness Diagnostics Development Incubator,” a yearlong collaborative forum designed to bring together teams of multidisciplinary innovators to look at diagnostic protocols, processes, and tests anew, with an eye to accelerating better diagnostic solutions. In this forum, we’ll bring together researchers, diagnostics companies, patient representatives, government representatives, and industry funders to brainstorm on ways to remove roadblocks to innovation. We’ll also feature lectures covering areas such as concept seed funding, getting through the regulatory pipeline, and fundamentals of low-cost diagnostics design.

This incubator is designed to complement the LymeX Tick-Borne Disease Innovation Accelerator, which will be offering prizes for the development for better early Lyme diagnostics. [Lyme X is funded with $25 million from the Steven & Alexandra Cohen Foundation and co-managed with the U.S. Department of Health and Human Services (HHS).] The Invisible Incubator is way to gain a competitive edge in this competition, by making it easy to engage with clinical, lab, and collaborators, and by participating in forums where past and emerging technologies will be discussed.

If you’d like to join the effort to improve Lyme diagnostics, please watch this educational primer on Lyme testing, then join us Saturday, October 30, 1:00 to 2:30 p.m. EST.* Registering at https://www.hack.invisible.international/ (*This presentation will be recorded and posted on Invisible’s website after the event.)

This continuing medical education course was funded by the Montecalvo Platform for Tick-Borne Illness Education, through Invisible International, a 501(c)(3) nonprofit foundation dedicated to reducing the suffering associated with invisible illnesses and social marginalization through innovation, education, and data-driven change projects. You can sign up to receive news and updates at https://invisible.international/mission

Other related courses: Basic principles of diagnostic testing7 years of blood-based Lyme disease testingCase studies in early Lyme disease.

Photo credit: Pollyana Ventura, iStock

The state of tick-borne illness diagnostics: Learn, engage, and accelerate

Invisible International is launching a yearlong “Tick-borne Illness Diagnostics Development Incubator,” starting with an online briefing, “The State of Tick-Borne Illness Diagnostics: Learn, Engage, Accelerate.”When: Saturday, October 30, 1:00 to 2:30 p.m. EST.
Registration: https://www.hack.invisible.international/

The weak link in reducing the public health burden of Lyme disease and other tick-borne illnesses is the lack of fast, cheap, and reliable diagnostic approaches. Early Lyme diagnoses are often delayed because the Lyme screening tests aren’t reliable in the first month after infection and not everyone produces or notices a bullseye rash. In the later stages of the disease, antibody testing can be unreliable in the sickest patients, those whose antibody production may be hobbled by concurrent infections or a weak immune system. There’s also no simple diagnostic roadmap to follow when multiple tick-borne pathogens may be involved.

This briefing will mark the start of Invisible International’s “Tick-borne Illness Diagnostics Development Incubator,” a yearlong collaborative forum designed to bring together teams of multidisciplinary innovators to look at diagnostic protocols, processes, and tests anew, with an eye to accelerating better solutions. We’ll bring together researchers, diagnostics companies, patient representatives, government representatives, and industry funders to brainstorm on ways to remove roadblocks to innovation. We’ll also feature lectures covering areas such as concept seed funding, getting through the regulatory pipeline, and fundamentals of low-cost diagnostics design.

This incubator is designed to complement the LymeX Diagnostics Moonshot, which will be offering prizes for the development for better early Lyme diagnostics over three phases. [Lyme X is funded with $25 million from the Steven & Alexandra Cohen Foundation and co-managed with the U.S. Department of Health and Human Services (HHS). Competition details will be posted later this year at Challenge.gov. ] The Invisible Incubator is way to gain a competitive edge in this competition, by making it easy to engage with clinical, lab, and collaborators, and by participating in forums where past and emerging technologies will be discussed.

The “The State of Tick-Borne Illness Diagnostics” briefing will feature:

Introductions: 

Mark Lovell, PhD, former Chairman and Chief Scientific Officer at ImPACT Applications, Inc.; Chair of Invisible’s Lovell Innovation Platform and Advisory Board

Valerie Montecalvo, President, Bayshore Recycling; Chair of Invisible’s Montecalvo Platform for Tick-Borne Illness Education and Strategic Initiatives

Keynote: The human cost of poor diagnostics
Nicole Bell, executive, entrepreneur, and author of What Lurks in the Woods: Struggle and Hope in the Midst of Chronic Illness, A Memoir

·Demystifying commercialization

Rhonda Shrader, Invisible International Innovation Chair; Executive Director, Berkeley Haas Entrepreneurship, UC Berkeley; and NSF I-Corps, Bay Area Node Director

Amanda Elam, CEO/Cofounder of Galaxy Diagnostics, Inc. and Entrepreneurship Research Fellow at Babson College

Why patient input is important

Emily Lovell, Invisible International Advisory Board and computer science researcher/educator

Perspectives from the diagnostic trenches

Representatives from three specialty labs will share their take on today’s diagnostic technologies today and what’s needed in the future

Invisible International

Nev Zubcevik, DO, CMO, Call for better diagnostic tools from the clinical trenches

Laura Lott, CEO, Learn, engage, accelerate: Why your team should join the challenge

The “Tick-borne Disease Diagnostics Innovation Incubator” is a component of Invisible’s Lovell Innovation Platform, funded by a trailblazing donation by Mark and Eileen Lovell. Thanks to their generous support, Invisible International is delivering programs that will change the landscape of tick-borne illness and other invisible illnesses through community action, education, and research.

When: Saturday, October 30, 1:00 to 2:30 p.m. EST.*
Registration: https://www.hack.invisible.international/

*This presentation will be recorded and posted on Invisible’s website after the event

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