Archive for the ‘Lyme’ Category

Homicide, Two Assaults, And Suicide in Lyme Patient

https://danielcameronmd.com/homicide-two-assaults-suicide/

HOMICIDE, TWO ASSAULTS, AND SUICIDE IN LYME DISEASE PATIENT

lyme-disease-suicide

A case report by Dr. Robert Bransfield and colleagues describes a patient who developed substance abuse issues after struggling with Lyme disease and was eventually charged with homicide and two assaults. The patient later committed suicide.

By 

The article entitled “A Fatal Case of Late Stage Lyme Borreliosis and Substance Abuse,”1 describes a patient exhibiting aggressiveness, violence, and homicidality. Like many Lyme disease patients, the man experienced a delay in diagnosis and treatment. (One study reports that subjects enrolling in a trial of Lyme encephalopathy were ill an average of two years before being diagnosed.2)

The patient’s Lyme disease symptoms progressed. “Further disease progression contributed to him feeling desperate as a result of multiple late-stage symptoms,” wrote Bransfield et al.  According to Fallon et al., the number of Lyme disease patients who feel desperate is not clear. 2

Based on more than 30 years of experience treating Lyme disease patients, Dr. Bransfield previously described a wide range of neuropsychiatric symptoms in Lyme disease patients. “… neuropsychiatric symptoms, usually presenting with significant comorbidity which may include developmental disorders, autism spectrum disorders, schizoaffective disorders, bipolar disorder, depression, anxiety disorders (panic disorder, social anxiety disorder, generalized anxiety disorder, posttraumatic stress disorder, intrusive symptoms), eating disorders, decreased libido, sleep disorders, addiction, opioid addiction, cognitive impairments, dementia, seizure disorders, suicide, violence, anhedonia, depersonalization, dissociative episodes, derealization and other impairments.”3

“Further disease progression contributed to him feeling desperate as a result of multiple late-stage symptoms.”

The patient’s condition worsened.  “The pathophysiological effects of the infection resulted in an increased number and severity of multisystem symptoms, disability, and substance abuse,” the authors wrote. “He experimented with multiple substances in an effort for relief.”

The authors added, “During acute deterioration of his mental state from phencyclidine withdrawal, NMDA agonism increased, he committed a homicide, two assaults, and suicide.”

In an earlier study, Dr. Bransfield described substance abuse, cannabis use, and intoxication in Lyme disease patients.4

Bransfield and colleagues advised prompt diagnosis and treatment of Lyme disease to help prevent addictive disorders, substance abuse, and death.

“More effective diagnosis and treatment and attention to substance abuse potential in these patients may help prevent some cases of addictive disorders, substance abuse, and death.”

Related Articles:

Mental health in COVID-19 and Lyme disease patients

Lyme disease and depression

Lyme disease patients at risk for suicide

References:
  1. Bransfield RC, Embers ME, Dwork AJ. A Fatal Case of Late Stage Lyme Borreliosis and Substance Abuse. Abstract. Journal of Affective Disorders Reports. April 2023. Last viewed 4/1/23 https://www.sciencedirect.com/science/article/pii/S2666915323000641?via%3Dihub
  2. Fallon BA, Keilp JG, Corbera KM, et al. A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. Neurology. Mar 25 2008;70(13):992-1003. doi:10.1212/01.WNL.0000284604.61160.2d
  3. Bransfield RC. Neuropsychiatric Lyme Borreliosis: An Overview with a Focus on a Specialty Psychiatrist’s Clinical Practice. Healthcare (Basel). Aug 25 2018;6(3)doi:10.3390/healthcare6030104
  4. Bransfield RC. Aggressiveness, violence, homicidality, homicide, and Lyme disease. Neuropsychiatr Dis Treat. 2018;14:693-713. doi:10.2147/NDT.S155143

______________

**Comment**

Most are not diagnosed and treated promptly and nobody has a clue how many patients are going through something similar to this poor man.  Most of us feel desperate at some point.

For more:

Category:

Lyme, Psychological Aspects, research

Bedridden Woman Diagnosed with ALS, Ended Up Having Lyme/MSIDS

https://twitter.com/dralmiller/status/1575837175484411905

Tweet from Dr. Alfred Miller:

Recent case: 30 y/o female, bedridden, returned from the Mayo Clinic diagnosed with ALS.This patient was then properly tested for Borrelia & coinfections.  Results confirmed Borrelia & Bartonella infection.Appropriate antibiotics began. Now patient able to ascend & descend stairs.   
Although this is a year old, it’s a potent reminder that things are often not what they seem – particularly with neurological diseases that have been slapped with a label but have many causes.
Dr. Miller has been an outspoken advocate for Lyme/MSIDS patients for years.  He started on this journey after his own daughter in law was given an ALS diagnoses but struggled with tick-borne illness.  Like so many patients, she tested on the CDC ELISA testing, and was told it couldn’t be Lyme/MSIDS.  Miller wouldn’t accept this prognosis and sent her blood to a specialty lab where sure enough, it came back positive.
Miller believes all patients who have been given a diagnosis of a neurodegenerative disease—including ALS, MS, lupus, and fibromyalgia—should be evaluated for Lyme disease.

Our most ardent supporters are usually infected or have loved ones that are infected.  All of a sudden, they “get it,” after having to travel the same pot-holed riddled path as suffering patients and see for themselves the complete mismanagement of a complex disease that hasn’t made any forward progress in over 40 years.
This is the reason I feel strongly the CDC/FDA/NIH should not be given one more dime.  These agencies don’t care about public health at all and are in fact complicit in a crime against sick patients, whom they not only haven’t helped them one tiny bit, but have in fact abused and neglected them.
For more on Dr. Miller:

Category:

Lyme, Testing, Treatment

Dr. Alan McDonald: Lyme Links to Alzheimer’s, Cancer, Leukemia, Liver Damage, & Suicide

**Comment**

So thankful someone listened to the entire podcost and broke it down in this handy article.  I try to do this but sometimes get overwhelmed with the length and amount of material, and neglected to break down Dr. McDonald’s latest work.  I regret this as I consider McDonald an expert and a true help for Lyme patients.  Every word that proceeds out of this man’s mouth is informative.  Now we can all enjoy the information he presented in the podcast in the article which follows.  Enjoy!

https://www.lymedisease.org/lyme-links-alzheimers-and-more/

Pioneering researcher discusses Lyme links to Alzheimer’s and more

April 4, 2023

From the Tick Boot Camp Podcast:

In this eye-opening episode, Dr. Alan McDonald unveils his latest findings, revealing the connections between Lyme disease and an array of serious health issues, including Lewy body dementia, liver damage, leukemia, brain cancer, and even suicide.

This compelling conversation underscores the urgency of broadening our understanding of Lyme disease to better support and treat patients.

Dr. McDonald’s research has led to several groundbreaking discoveries, including:

  1. Lyme Disease Triggers Lewy Body Dementia: Dr. McDonald has discovered a link between Lyme disease and Lewy body dementia, a neurodegenerative disorder that affects the brain. His research has shown that Lewy bodies contain Borrelia DNA, the bacteria responsible for Lyme disease, challenging previous assumptions about the nature of Lewy bodies.
  2. Lyme Disease Causes Liver Damage: Dr. McDonald has found that nearly 20% of acute early Lyme patients suffer from liver issues related to the disease. Early treatment of Lyme disease can help prevent liver damage and its detrimental effects on the body’s detoxification process.
  3. Lyme Disease Linked to Leukemia: Dr. McDonald’s research has also identified a connection between Lyme disease and chronic lymphocytic leukemia, opening up possibilities for improved diagnosis and treatment options for patients affected by both conditions.
  4. Lyme Disease Initiated Brain Cancer: The podcast highlights Dr. McDonald’s ongoing research on glioblastomas, a form of brain cancer, and its association with Lyme disease. This research has the potential to lead to new treatment options and a better understanding of the disease’s impact on the brain.
  5. Lyme Disease and Suicide: The podcast also addresses the crucial connection between Lyme disease and suicide, emphasizing the importance of understanding and supporting patients struggling with the psychological impact of Lyme disease.
  6. Lyme Disease Intelligently Evades Tests: Dr. McDonald’s research illustrates the Lyme bacteria’s ability to sequester itself in the body, leading to false-negative test results and leaving many Lyme patients undiagnosed and untreated.

Click here to listen.

It’s also available on Apple podcasts, Google podcast, and Spotify.

______________

**Comment**

As I read this, I was again hit hard with the fact that this seriously incredible information isn’t even on the radar of mainstream research/medicine/public health.  After 40 years we haven’t budged on understanding this complex illness which typically includes far more than just Lyme, which is why many call it MSIDS or multi systemic infectious disease syndrome or Lyme and company.  Lyme alone is formidable, but add in a few coinfections just as nasty and you are one sick dog.  McDonald and a few others are the rare scientists who aren’t led by the government narrative/paradigm and who do not have conflicts of interests that obviously make them biased.  Further, they obviously look harder and don’t quit when they get the accepted result.

Hopefully the last few years have awakened many to the fact science has been hijacked; however, science has always been hijacked in many areas and Lyme/MSIDS is one of them.  I would put vaccines, cancer, autism, MS, chronic fatigue, and many others in this camp as well.  Currently, these diseases are huge money makers and the ‘powers that be’ are raking in royalties and other monies and don’t want their cash cows to stop.  Public health is the last thing on their minds.  If these diseases are in fact triggered or caused by hidden infections, they could be helped by cheap, already existing antimicrobials that could be repurposed.  As we have clearly seen with COVID, those controlling the narrative simply can’t allow this to happen.

For more:

Category:

Alzheimer's, Lyme, Psychological Aspects, research

Lyme Can Interfere With How Your Eyes & Brain Work Together

https://www.lymedisease.org/padula-lyme-interferes-with-eyes-brain/

Lyme can interfere with how your eyes and brain work together

April 6, 2023

By William V. Padula, OD SFNAP FAAO FNORA

Tick-borne infections can affect your vision in many ways. There may be blurring, double vision, light sensitivity, visual distortion, difficulty with balance, dizziness, and problems focusing, to name several.

Vision is more than just the image that we see. 70% of all the sensory nerves in the entire body come from the eyes. In fact, the eyes don’t actually see. Rather, they are sophisticated ‘cameras’ through which the brain does the seeing.

The brain has two primary means for organizing visual information. One process (the focal process) is the conscious or attentional process. This part of our vision provides information about detail so that we can see to identify objects. We link our thinking or cognitive process to this portion of vision.

However, there is a second process called the spatial or ambient process. It sets up the ability to use the focal process. The spatial visual process matches information with the balance centers and sends information to the cortex to organize how we see space before we actually see the detail.

The focal process isolates on details. Using the analogy of the forest and the trees, the focal process sees the ‘trees’ and the spatial visual process sees the world as the ‘forest.’ Together the spatial process gives orientation and organization to stabilize the visual process first with proprioception (information from the muscles and joints) establishing a grounding or stability with gravity to engage the spatial visual process first before looking at the detail.

The spatial visual process grounds the visual process and cortex so that the focal process can disassociate to look at a detail without losing orientation to our position sense. When the spatial process becomes unstable, the visual world becomes detail oriented (suddenly the visual world sees only the ’trees’) and this becomes over-whelming, similar to driving in a snowstorm at night with your high beam headlights on.

Maintaining the balance

There is a balance between the two visual processes that must be maintained. This balance provides efficiency, accuracy and the ability to adapt to change in our visual as well as sensorimotor world. (Sensorimotor refers to how we use our senses to interact with our surroundings.)

Lyme-related diseases often produce inflammation, which can disrupt the balance between the two visual processes. Because vision is connected neurologically to respiration and cardio function through the autonomic nervous system, any changes with the visual process will affect the autonomic system.

The imbalance in the visual process produces stress and affects the cardio-rhythms and respiration. A tick-borne infection that becomes neurological will not only directly affect the brain processing associated with visual processing, but may also affect the soft tissue and joints, cardio-respiratory systems, the vestibular system, etc. In turn the neurological imbalance affects both the visual process in the brain directly as well as the indirect relationships with other motor and sensory systems.

Research

One way of evaluating how the eyes and brain work together is called a visual evoked potential (VEP) test. It measures the electrical signal that the brain’s visual cortex generates in response to visual stimulation. Research shows that abnormal results on this test strongly indicate tick-borne disease.

My colleagues and I have also found another potential eye-related biomarker for tick-borne infections—a hazy white ring surrounding the optic nerve. This is called peri-papillary ischemia, and it is highly associated with tick-borne infections. We believe it arises from biofilms that clog the narrow capillary vessels around the optic nerve, blocking blood flow.

In my practice, I have found that changes in the VEP brain waves can be brought back to normal through use of special lenses and various therapeutic techniques. This therapy helps the brain reset how it processes information and resolves many of the patient’s visual challenges. This indicates that VEP abnormalities don’t have to be permanent.

Balance and Movement

The balance difficulties associated with tick-borne disease often come from a mismatch of information between the spatial visual process and other balance centers. This produces a condition know as Visual Midline Shift Syndrome (VMSS).

When there is a mismatch of visual spatial information and information from muscles, joints and the vestibular, the visual midline can become shifted. When this occurs, persons will drift when walking or feel as if they are not as stable. For example, people with this visual spatial imbalance often feel that they are too close to one side of the road when driving. Or they may feel like they are being pulled to one side when walking.

VMSS can be improved by the use of special glasses called “yoked prisms.” These realign the visual midline and re-center the center of mass. Balance can in many cases be improved very quickly when these prisms are prescribed properly.

A Part of the Solution: Rehabilitation of Vision

The following checklist provides a self-assessment for potential symptoms associated with visual processing that may be affected by tick-borne disease.

  • Difficulty converging the eyes to maintain alignment for reading ____
  • Difficulty maintaining focus of the eyes for near vision activities ____
  • Losing place when reading  ____
  • Blurry vision that changes  ____
  • Dizziness ____
  • Difficulty with attention and concentration ____
  • Loss of comprehension when reading  ____
  • Difficulty with visual memory  ____
  • Avoids looking at objects close to the face  ____
  • Difficulty with balance when walking  ____
  • Drifting when walking ____
  • Experiences feeling of being overwhelmed when in busy, crowded environmen____
  • Bumps into objects ____
  • Light and glare sensitive ____

If you are experiencing any of these symptoms, you need a careful assessment of your neuro-visual process. There are some neuro-optometrists who specialize in working with persons with tick-borne infections.

The treatment approach will differ from a standard vision exam. It will include brain wave testing (VEP) and a careful assessment of the neuro-visual-postural organization through instruments to assess weight shift during walking and shift in visual midline/center of mass (COM).

This testing should be accomplished in conjunction with the physician treating the tick-borne infection and not in place of it. Services from psychologists for counseling and/or neuropsychological testing may also be important. Persons with tick-borne infections will need an inter-professional approach for treatment. When the visual process becomes compromised, the problem often continues even after the tick-borne infection has been treated and resolved.

Dr. William Padula is the founder of the Padula Institute of Vision Rehabilitation, in Guilford, Connecticut. More information at his website: padulainstitute.com

________________

**Comment**

Advances like this are always encouraging; however, it’s important to remember that oftentimes proper treatment will ameliorate symptoms entirely or will at least improve them vastly.  That said, we need all the tools in our toolbox we can get!

For more:

And again, these things are not rare.  They are rarely reported.  Big Diff!

Category:

Eye Issues, Lyme, Treatment

FDA Draft Guidance Addresses Clinical Development of Drugs to Treat Early Lyme – Parts 1 & 2

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

FDA draft guidance addresses clinical development of drugs to treat early Lyme disease

Carl Tuttle

Hudson, NH, United States

APR 2, 2023 — 

The FDA is drafting guidance for Lyme Disease Drug Development. Not surprisingly they have completely mischaracterized the disease and target patient population. It looks like we have an important opportunity to educate them before sick patients aren’t included in the cohorts eligible to receive treatment. Similar to the vaccine, working with the wrong population will make treatments look effective even if they are not. It also prevents drug developers from being able to address what the real disease is and does. April 3 at 11:59 pm is the deadline for comments. Please consider commenting and/or sharing with others.

Announcement:
https://www.raps.org/news-and-articles/news-articles/2023/2/fda-draft-guidance-addresses-clinical-development

Draft Guidance: 
https://www.fda.gov/media/164949/download

Comment Here
https://www.regulations.gov/commenton/FDA-2022-D-2315-0002

Carl Tuttle’s Submitted comment…

Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Guidance for Industry – DRAFT GUIDANCE

Office of Communications,
Division of Drug Information Center for Drug Evaluation and Research
Food and Drug Administration

Focusing on the early stage of Lyme disease with bulls-eye rash is the root cause of this failed Public Health Response. Less than 50% of Lyme patients developed that rash as recorded by Epidemiologists in the State of Maine.

2011,  42% developed the rash:  http://www.maine.gov/dhhs/mecdc/infectious-disease/epi/vector-borne/lyme/documents/2011-lyme-legislature.pdf

2012,  49% developed the rash:  http://www.maine.gov/dhhs/mecdc/infectious-disease/epi/vector-borne/lyme/documents/2012-lyme-legislature.pdf

2013,  51% developed the rash:  http://www.maine.gov/dhhs/mecdc/infectious-disease/epi/vector-borne/lyme/documents/2013-lyme-legislature.pdf

2014,  57% developed the rash:  http://www.maine.gov/dhhs/mecdc/infectious-disease/epi/vector-borne/lyme/documents/2014-lyme-legislature.pdf

Lyme was pigeonholed into the category of “Hard to Catch and Easily Treated” through an elaborate scheme focusing on the acute stage of disease with bulls-eye rash and early treatment while avoiding the horribly disabled Lyme patient population. [i] The Centers for Disease Control financed the dishonest science using taxpayer dollars [ii] under grant# RO1 CK 000152 [iii] which has misguided a nation of intelligent physicians through the deliberate suppression of evidence of persistent Borrelia infection after aggressive antibiotic treatment. [iv]

This well-orchestrated scheme has misclassified Lyme as a low-risk and non-urgent health threat which actually belongs in the same health threat category as AIDS, Zika, cancer etc. and requires a Manhattan Project to understand how the infection it disables its victim just like untreated strep throat leads to rheumatic fever causing irreversible heart damage, untreated HIV leads to AIDS with substantial disability and death and untreated syphilis leads to progressive disability and dementia. Patients with a prolonged exposure to the Lyme disease pathogen are almost always incapacitated. Many these patients are often diagnosed with the chronic diseases of our time with no known etiology as exposed in the “Under our Skin” extended trailer:

Under Our Skin – Extended Trailer (please watch)
https://www.youtube.com/watch?v=sxWgS0XLVqw

There are no guidelines for treating the late stage disabled Lyme patient (who ends up bedridden or in a wheelchair) listed in the recently revised IDSA Lyme Treatment Guideline because that class of patient has been deliberately avoided at all costs so as not to expose the truth while keeping the current paradigm intact.

In fact, the IDSA does not want clinicians to rule out Lyme in patients who have been diagnosed with the chronic diseases of our time:

June article in Medscape by past IDSA president Paul Auwaerter

A Quick Tour of the New Lyme Disease Guideline
https://www.medscape.com/viewarticle/951589

Paul G. Auwaerter, MD

June 14, 2021

Excerpt:

“Of importance, the guideline goes out of its way to cite the lack of evidence for performing Lyme disease tests, specifically routine testing in cases where there’s no evidence or link to Lyme disease. Examples include someone who is asymptomatic after a tick bite, even when they have a neurologic condition such as amyotrophic lateral sclerosis, multiple sclerosis, Parkinson’s disease, dementia, or any kind of new-onset seizures or psychiatric illness. In children, behavioral and developmental disorders don’t warrant assessing a Lyme disease serology.”

____________________________________

I sent an email to Dr. Auwaerter pointing out that a recent study identified tick-borne infections in nine out of ten institutionalized adolescents: [v] [vi]

Study detects tick-borne illness in teens hospitalized for depression
https://www.lymedisease.org/hospitalized-teens-lyme-depression/

-Ten patients were diagnosed with DSM-5 Major Depressive Disorder, seven were additionally diagnosed with Generalized Anxiety Disorder, and three had made serious suicide attempts.

-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.

__________________________________________

Instead of playing along with the dishonesty by avoiding the truth/evidence that Lyme is a disabling disease, our public health officials responsible for this travesty should be thoroughly investigated and held accountable to ensure this atrocity will never repeat itself.

Summary:

Stop focusing on the early stage of Lyme disease with bulls-eye rash and find a cure for all stages of the disease. Include patients in this study who are horribly disabled by an infection capable of destroying lives, ending careers while leaving its victims in financial ruin as reported by the Lyme patient population for the past thirty years!

Respectfully submitted,

Carl Tuttle
Hudson, NH

References (please read them!)

  1. NEWS: Former patient who testified as a child about Lyme disease recalls encounter with Sen. Ted Kennedy 
    https://www.lymedisease.org/186/
    Evan White testified from his wheelchair in 1993 at Senator Ted Kennedy’s Hearing, Washington DC
    Excerpt: 
    “No one could hear or feel the moment of that child and not be moved,” Kennedy explained to the [Boston] Globe at the time. Anyone who wasn’t moved, he said, “hasn’t got a heart.”
  2. Feb 4, 2020 complaint regarding the misuse of taxpayer dollars  https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/25876147
  3. Subjective Symptoms after Treatment of Lyme Disease  https://reporter.nih.gov/search/14E9C8084784C1D47598B8961CAA4A01A2FFCEB861BF/projects?shared=true&legacy=1
  4. Lyme borreliosis: diagnosis and management  https://www.bmj.com/content/369/bmj.m1041/rr-1
  5. A Quick Tour of the New (IDSA) Lyme Disease Guideline  https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/29231613
  6. A Quick Tour of the New (IDSA) Lyme Disease Guideline #2  https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/29263852

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/3146

FDA draft guidance addresses clinical development of drugs to treat early Lyme disease Part 2

Carl Tuttle

Hudson, NH, United States
APR 4, 2023 — 

As a follow-up to my previous comment to the FDA regarding “drugs to treat early Lyme disease,” please take a moment to read the comment below registered by the team at TruthCures. We all agree that early Lyme with bulls-eye rash does not represent the entire patient population and has been used by the IDSA and CDC to control and manipulate the narrative in order to support the vaccine business model of patent royalties and pharmaceutical profits. Chronic Lyme disease DOES NOT fit that model!

Comment from TruthCures:

Response to Docket No. FDA-2022-D-2315 for “Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment”

As a patient advocacy organization working to bring valid diagnostics and effective treatments to people with Lyme disease (LD), TruthCures supports innovation in therapeutics and properly designed trials to ascertain their efficacy. Thank you for the opportunity to comment on this guidance.

Trial Population

The trial population suggested in this guidance consists of “…subjects with early localized (i.e., a single EM lesion) or early disseminated (i.e., multiple EM lesions) disease, who reside in or traveled to a Lyme-endemic area.” Limiting any therapeutic trial to only cases presenting with erythema migrans (EM) rash will restrict the trial population to a minority cohort that may not be representative of the broader patient population.

The Centers for Disease Control and Prevention (CDC) estimates 476,000 LD cases in the United States each year (Kugeler et al 2021). However, in 2020, only 44,937 LD cases were reportable as “confirmed” or “probable” based on CDC surveillance criteria (CDC 2020). For diagnosis of a reportable case of early LD, CDC surveillance criteria require either a physician-diagnosed EM rash or laboratory confirmation of infection by methods that may include culture, nucleic acid amplification, immunohistochemical assay on biopsy or autopsy tissues, or two-tier serological testing (CDC 2022).

In clinical practice, diagnostic criteria set forth by the Infectious Diseases Society of America are virtually indistinguishable from the CDC surveillance criteria (IDSA 2006). With both sets of criteria requiring physician-diagnosed EM rash and/or laboratory confirmation, it stands to reason that the vast majority of EM rashes are being counted in the reported surveillance cases. In the public discourse, the absence of such context promotes a misconception that the prevalence of EM rash is based on the total of LD cases rather than the reported cases, creating an inflated perception of the prevalence of EM rash with Lyme.

A simple mathematical analysis illustrates the staggering difference between the narrative and reality.

● The literature frequently cites an EM rate of 60% – 80% (IDSA 2006, Steere et al 1998, CDC 2021). For calculation purposes we will use 70%.
● The public incorrectly believes EM cases are calculated as 70% of 476,000, or 333,200.
● Published studies state the EM rate is calculated based on reported LD cases—those meeting the IDSA and/or CDC surveillance reporting criteria (Kugeler 2020, Smith et al 2002, Seltzer et al 2000). For 2020, EM cases
would be 70% of 44,937, or 31,456.
● Therefore, the effective rate of EM is about 6.6% (31,456 out of 476,000).

It should not have to be said that results of a treatment trial limited to 6.6 percent of patients would not necessarily extrapolate to the entire Lyme disease patient population—particularly when it is unclear why the minority exhibit a distinct cutaneous manifestation. Indeed, Kannangara and Patel note, “EM seems to correlate more with the arthropod than the associated pathogen. The common belief is that EM is caused by B. burgdorferi. The presence of an organism in a skin biopsy culture or PCR does not necessarily mean that it is the cause of EM.” (Kannegara 2020)

Efficacy Endpoints

From the guidance document:

“Clinical success should be defined as resolution of EM and continued absence of objective manifestations of Lyme disease without need for additional antibacterial treatment for Lyme disease.”

“Clinical failure should be defined as the presence of unresolving or recurrent EM, objective manifestations of Lyme disease, or the need for additional antibacterial treatment for Lyme disease.”

Remission of cutaneous symptoms has not been determined to correlate with disease cure (IDSA 2006, Steere et al 2016, Feder et al 2011), and, as is common knowledge, there is no diagnostic method available to determine either cure or disease stage.

It is commonly reported in the literature that EM rash resolves on its own in three to four weeks (Kardos 2002, Feder 1993, Nadelman 1997, Wheaton 2012, Dressler 1999). Therefore, the definition of clinical success (“resolution of EM”) could not necessarily be attributed to the treatment. Likewise, clinical failure could not be attributed to lack of efficacy if efficacy itself is not ascertainable. Lacking the ability to determine success or failure based on EM resolution, an alternative would be to run a separate trial to determine whether the therapeutic has any effect on time to resolution of EM.

Additionally, there is the possibility that patients present with EM rash and no other symptoms. In these cases, without the ability to correlate disease cure with resolution of EM, there is no other way to gauge efficacy of a therapeutic.

Conclusion

Using only patients who present with EM rash for a therapeutic efficacy trial would exclude 93% of patients, with no insight into the factors (e.g. genetic or comorbidities) that cause certain people to develop the rash. Resolution of EM rash is not an indication that Lyme disease has been cured or spirochetes eradicated.

TruthCures’ mission is to enable Lyme disease victims to obtain a valid diagnosis and effective medical care. While we support endeavors to discover novel treatments, we believe valid diagnostics must come first. As long as Lyme disease cannot be accurately and consistently diagnosed, therapeutics cannot be developed for the right patients using the right efficacy endpoints.

Following a complaint to FDA’s Office of Criminal Investigation, TruthCures presented to investigators in-person, in October 2021. We provided evidence that Lyme disease diagnostics have been predicated on improperly cleared devices going all the way back to 1995. The investigators agreed with our diagnostic device regulatory expert’s assessment of those devices. We suggest focusing FDA’s Lyme disease efforts on completing that investigation so valid tests can be developed and marketed rather than daisy-chaining off a manipulated standard.

It is well known that seronegative Lyme presents one of the biggest challenges in validating diagnostics. The gap between reported surveillance cases (44,937 in 2020) and CDC’s estimated annual cases (476,000) indicates more than 400,000 patients per year may be falling through the cracks due to the inability of serology to properly diagnose them. Many of these victims lose everything—family, friends, job, home, retirement savings, education, and more—due to chronic illness and the stigma of having a “contested” disease. We respectfully request you take a step back and reassess whether it makes sense to produce any guidance that effectively leaves those patients out of the equation once again.

REFERENCES

  • Kugeler KJ, Schwartz AM, Delorey MJ, Mead PS; Hinckley AF. Estimating the
    Frequency of Lyme Disease Diagnoses, United States, 2010-2018. Emerg Infect Dis
    2021;27: 616-619.
  • Centers for Disease Control and Prevention. “2020 Lyme Disease Data: Provisional Data.” Centers for Disease Control and Prevention, 2020,https://www.cdc.gov/lyme/datasurveillance/provisional-lyme-cases.htm
  • Centers for Disease Control and Prevention. “2022 Lyme Disease Surveillance Case Definition.” Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 1 Jan. 2022, www.cdc.gov/lyme/resources/2022-surveillance-case-definition.html
  • Infectious Diseases Society of America. “The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America.” Clinical Infectious Diseases, vol. 43, no. 9, 1 Nov. 2006, pp. 1089-1134.
  • Steere AC, Sikand VK, Meurice F, et al. Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. N Engl J Med. 1998;339(4):209-215. doi: 10.1056/nejm199807233390401.
  • Centers for Disease Control and Prevention. “Signs and Symptoms of Untreated Lyme Disease.” Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 2021. https://www.cdc.gov/lyme/signs_symptoms/index.html
  • Smith, R. P., Schoen, R. T., Rahn, D. W., Sikand, V. K., Nowakowski, J., Parenti, D. L., …& Steere, A. C. (2002). Clinical characteristics and treatment outcome of early Lyme disease in patients with microbiologically confirmed erythema migrans. Annals of Internal Medicine, 136(6), 421-428.
  • Seltzer, E. G., Gerber, M. A., Cartter, M. L., Freudigman, K., & Shapiro, E. D. (2000). Long-term outcomes of persons with Lyme disease. JAMA, 283(5), 609-616.
  • Kannangara, Don Walter and Patel, Pritiben. “Report of Non-Lyme, Erythema Migrans Rashes from New Jersey with a Review of Possible Role of Tick Salivary Toxins.” Journal of Medical Entomology, vol. 57, no. 1, 2020, pp. 28-34.
  • Kardos, Marton, et al. “Erythema migrans resolving without antibiotic treatment in a patient with confirmed Lyme disease.” Journal of the American Academy of Dermatology, vol. 47, no. 3, 2002, pp. S204-S207. doi: 10.1067/mjd.2002.123625.
  • Feder, Henry M. Jr., et al. “A Critical Appraisal of ‘Chronic Lyme Disease’.” New England Journal of Medicine, vol. 328, no. 7, 1993, pp. 921-924. doi: 10.1056/NEJM199304013281311.
  • Nadelman, Robert B., et al. “Does this Patient Have Lyme Disease?” Annals of Internal Medicine, vol. 127, no. 12, 1997, pp. 1109-1113. doi: 10.7326/0003-4819-127-12-199712150-00005.
  • Wheaton, Anne J., et al. “Lyme Disease in Primary Care Practice.” Journal of the American Board of Family Medicine, vol. 25, no. 6, 2012, pp. 817-820. doi: 10.3122/jabfm.2012.06.120055.
  • Dressler, Franz, et al. “The Clinical Spectrum and Treatment of Early Lyme Borreliosis in Patients with Skin Manifestations Only.” Journal of the American Academy of Dermatology, vol. 41, no. 3 Pt 1, 1999, pp. 1-7. doi: 10.1016/S0190-9622(99)70134-7.
  • Steere, A. C., Strle, F., Wormser, G. P., Hu, L. T., Branda, J. A., Hovius, J. W., … & Stanek, G. (2016). Lyme borreliosis. Nature Reviews Disease Primers, 2, 16090.
  • Feder, H. M., Johnson, B. J., O’connell, S., Shapiro, E. D., Steere, A. C., Wormser, G.P., & Ad Hoc International Lyme Disease Group. (2007). A critical appraisal of “chronic Lyme disease”. New England Journal of Medicine, 357(14), 1422-1430.

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Activism, Lyme, Testing