-  Tick-Borne Disease Working Group      -  21st Century Cures Act 
  -  Charter 
  -  Meetings 
  -  Reports 
  -  Contact Us 

                      -   
                      -   
                      -   
                      -   
                      -   

# TBDWG November 17, 2020 - Written Public Comment

***This webpage displays the written comments received by the Tick-Borne Disease Working Group for the November 2020 meeting. The opinions expressed in each comment displayed on this webpage belong solely to the author of the comment and do not necessarily reflect the opinions of the Department of Health and Human Services (HHS) or the Tick-Borne Disease Working Group. Any information provided in the comments displayed on this page has not been verified by HHS.***

----

## Anonymous 1 

I’m 31 years old. For the past two years, I have been fighting for my life. I was bitten by a tiny tick in 2018 that left me with over 50 symptoms. The 3 weeks of doxycycline I was prescribed didn’t do anything to rid my body of the disease. I went from being fairly active and healthy to practically disabled in a short period of time. I’ve had multiple visits to the emergency room, and I even spent time in the hospital, due to the effects the disease has caused, and yet, there was no determination on what was causing my issues. I have been deemed as anxious and paranoid by multiple doctors. How does one suddenly become “crazy” overnight? It’s true that one would not understand the horrible effects of this disease until they contract it themselves.

I live in so much pain that I can hardly function. My medical bills are overwhelming, and I can hardly make it for even just a few hours at my desk job each day. It’s absolutely horrific how such a tiny creature can cause so much destruction. Yet, it’s even more horrific how this disabling disease is brushed aside, as if it doesn’t even exist. How can such seriously ill patients be tossed aside, as if they are meaningless?  It’s tragic. Chronic Lyme absolutely exists. I know 20+ people in my small hometown that live with Lyme, including a doctor, a pharmacist, nurses, etc. that all share this view. Why? Because, again, they have witnessed it firsthand. Please, we are tired of being overlooked. The suffering from chronic symptoms is torture enough, but the absolute negligence from the medical community leaves so many without hope and a will to fight. As Lyme cases continue to rise, the truth is coming to the light.

I think I speak for all when I say that chronic Lyme should absolutely be a valid medical diagnosis. We desperately need and deserve this proper recognition. Please do the right thing.

Thanks for your consideration!

----

## Anonymous 2 

On November 9, 2017, I got deathly ill after receiving some Dysport injections. I thought I was going to die. My heart raced uncontrollably for no reason. My bowels and kidneys stopped working for a time. I got huge ulcers in my mouth and I had no saliva, no matter how much water I drank. My stomach hurt so bad and If I tried to eat anything my stomach got so bloated and distended it felt like it was going to explode. I was weak as a kitten. I had no strength or energy. I Had night terrors and I was lucky if I could get 2 hours of sleep a night. I don’t know if the injections had lyme disease in them or if it was dormant in my system and my immune system was damaged and it allowed the lyme to take over. I don’t  know for sure and I may never know how I contracted it. I do not recall being bit by a tick, but I was bit by mosquitos. About 6 weeks after the injections, I did get a bull’s eye rash on my left forearm, but lyme disease was not on my radar. It never even crossed my mind. I had barely even heard of it.

At any rate, I traveled all over the southeastern United States going from doctor to doctor to try to find out why I was so sick. I even went to the [redacted] which was the biggest waste of time ever! I saw 40 to 50 doctors and no one thought to test me for lyme disease, but several did ask If I had seen my psychiatrist! Do you know how insulting that is?  After two long, miserable years, I was finally tested and diagnosed with a Western Blot blood test. I have 4 positive bands which is not considered positive by CDC standards. That is a real crock! As sick as I was, I had to travel 300 miles to find a doctor to treat me. He does not accept insurance. I have wiped out my 401k and have just about bankrupted myself trying to treat this horrific disease. I have I have been treating for 13 months now and I am still extremely ill even though I am taking 2 antibiotics and over 60 supplements a day!  I never knew it was possible to be so sick and still be alive. The suffering is an indescribable hell that most people cannot even fathom. Some days I wish I was not still here. The suffering is endless and there is no escape from this hell. Lyme has affected every part of my body. In addition to Lyme, I have been diagnosed with toxic mold, Mast Cell Activation Disorder, Dysautonomia, POTS and CIRS and Leaky Gut. I have debilitating joint pain, muscle pain and weakness. I am unable to stand for more than 5 minutes, my heart races all the time, walking is very painful and slow. I have cognitive issues and I cannot remember much of anything. I have ringing in my ears, blurry vision and dry crepy, burning skin. I am depressed and get awful anxiety on a frequent basis. It has also caused Osteoporosis and gum recession. I am on the verge of losing my teeth on top of everything else. I have to be very careful about what I eat. I still get painful bloating. I have aged 30 years since the onset of Lyme. I used to be a productive member of society and have some quality of life before Lyme. This horrific disease has totally and completely RUINED MY LIFE.

It is criminal how Lyme patient cannot get any help from traditional MD’s. How can they all be so ignorant? And how can they turn a blind eye and refuse to treat people who are suffering so much? And for so long? For me, it is now going on 4 years in this hell. If you are not going to have doctors treat and insurance pay, then you need to come up with a death with dignity act for people that do not wish to suffer for the rest of their life!

Opelika, Alabama

----

## Anonymous 3

I would like to recommend to the TBGWG the designation of chronic lyme. This recognition will set the path up for more research, treatment and validation for patients like myself whom suffer from continued symptoms of Lyme disease.  We want to feel better , have insurance that  covers our needs and  doctor’s  recognition of our symptoms. This  designation of chronic lyme will do just that.

Thank you

----

## Anonymous 4  

Dear HHS,

My name is anonymous, in Los Angeles. 

I spent 8 years getting diagnosed with lyme. I spent 18 months finding a doctor who would follow the very conservative IDSA guidelines for my diagnosis of late stage borreliosis. During that 18 months, my diagnosis was confirmed by 5 other doctors, in addition to the first doctor who found lyme. As it turned out, I had four species of borrelia, erhlichia, two species of ricksettia, babesia and bartonella, along with opportunistic infections in mucosal tissues (lung, ear, bladder, gut, throat) that preceded treatment.

I have spent 6 years in treatment. Treatment has cost at least $10,000 per year, out of pocket, and sometimes more. In this, my sixth year, I am finally getting leukopenia reversed. Lyme is an established cause of leukopenia, but because of the controversy around lyme, I have spent much of the last 6 years checking and double-checking that some other, more "proper" diagnosis was not being overlooked. Those costs were covered, and were far more than the $10,000-$15,000 I had to pay for treatment.

I didn't do diagnosis wrong. I did not fail to cooperate with my doctors. I did not fail to follow their advice. In the long and winding road to a diagnosis, I can give a concrete example of the problems of mis-education of doctors. I was told by an infectious disease professor of medicine that I could not have lyme because I had not lived in New England. She never asked, so she never knew I was born in New Jersey and lived there 5 years. She refused my request to run a lyme test she thought was credible. I was living in San Francisco, with an active outdoor lifestyle, when my illness began gradually, with nervous system issues and immune compromise.

It shouldn't have to be this hard. Please fix this by making chronic lyme legitimate and covered by insurance. I lost everything I ever cared about: my first home, my career, my standing in the middle class, among many other more precious things like impairments to quality of life and primary relationships.

I submit to you that the medical care and treatment I received would have been shocking, if the reason given were that I was gay, AIDs had not yet been identified as a cause of immune impairment, and the doctor did not like my sexual orientation. Having lyme should not be a worse taboo than anything else that one has ever heard-tell of. I should not need to submit this anonymously because of the gaslighting of my health condition by the medical profession, just so that the insurance industry can avoid cost obligations and displace risk-based treatment evaluations my doctor and I do together. Do cancer patients that die during treatment become a poster child for avoiding the "risk" of chemotherapy? How convenient that would be, for everyone but the patients!  

----

## Anonymous 5

Anonymous in Los Angeles

Tick-Borne Disease Working Group (TBDWG) members:

I am respectfully imploring you to vote to give Lyme Disease a chronic designation.  I have been struggling with Lyme Disease and Bartonella for over three years.  It took almost two years finally to receive a diagnosis as I was not one of the “lucky” few to have found the tick or bullseye rash on my body.  Over the two years prior to diagnosis, I suffered from a wide range of severe, scary and odd symptoms for which no doctor – internist, cardiologist, rheumatologist, allergist, infectious disease specialist, gastroenterologist, gynecologist or endocrinologist - could find a cause.  These symptoms included, among other things, chest pains and tightness; sensations of warmth around chest and upper back and traveling up into my head; brain fog; short-term memory loss; inability to focus or concentrate; a hampered ability to recall words; stiffness and pain in my neck; sensitivities on my scalp; abnormal, “funky" feelings in my head; weakness in my upper and lower extremities; extreme lethargy; inability to stand up or walk at times; pulsing, sharp pains that traveled to different places in my body; subdermal jitteriness throughout  body; sensitivity in my ears; and worsening eyesight. I was unable to work during most of this time and normal everyday tasks were often difficult to perform. 

It wasn’t until I went to a Lyme-literate doctor in 2019 – who takes no medical insurance and costs between $600-$1000 per monthly visit – that I received my Lyme Disease and Bartonella diagnoses.  Over the past year plus, I’ve been treated with numerous and massive amounts of expensive antibiotics, each with its own side effects, with the hope of eventually attaining the goal of feeling good about 90% of the time – at least that’s what my doctor says is the realistic hope for a Lyme patient, though, relapses are common. 

Being sick is awful.  Not knowing what the cause of your symptoms is awful.  Having inaccurate, inconsistent and ineffective testing for Lyme disease (and its co-infections) is awful.  Fighting to find a doctor who actually believes that your symptoms are real and not a figment of your imagination or a dramatic cry for attention is extremely awful.  Struggling to convince doctors that you still feel sick after four weeks on doxycycline and that your symptoms haven’t just magically disappeared is awful.  Being told that there is no such thing as long-term/chronic Lyme Disease, but yet no specialist can find anything else to blame for your symptoms is really awful.  Having to spend inordinate amounts of money out-of-pocket because insurance doesn’t cover “Lyme” doctors or the expensive treatments is pretty darn awful, (especially because Lyme Disease has prevented me from working consistently for the past several years).  There are so aspects of having Lyme Disease (and any of its co-infections) that are truly awful.  It would be so “nice” if I could spend my limited energy, focus and time on fighting this disease rather than fighting to be heard, believed and treated.

With a chronic designation by the TBDWG, I, along with the thousands of other people suffering knowingly or unknowingly with Lyme Disease, could focus on what really matters – regaining our health and our lives.  Please help all of us who have been struggling for so long with this very real, debilitating, chronic disease.

Thank you!

Anonymous

Greenwich, CT

----

## Anonymous 6

To whom it may concern,

I ask that you recognize that Lyme disease can be chronic. Given an appalling lack of data on persister cells and treatment options that tackle those, there is scientific evidence to suggest that Lyme can persist in the body for years even with antibiotic treatment.

I have been treated poorly by many medical professionals who did not believe my symptoms could be due to Lyme, which really got bad about 4 years after a known tick exposure. Had any one of those doctors believed me, I wouldn't still be in treatment today, nearly 10 years later, spending $20,000/year or more because insurance companies don't recognize chronic Lyme as a diagnosis.

Lyme needs accurate testing, insurance coverage, and doctors that believe that it can drag on for years or decades, even with treatment. If the TBD Working Group recognizes chronic Lyme, that would take us one step closer to effective testing, treatment, and maybe even a cure.

Thank you

Anonymous, Tucson, AZ

----

## Anonymous 7

I contracted Lyme disease on a hike in upstate New York in July 2019. "Thanks to" some immediate, more serious cardiac involvement symptoms, I went to a cardiologist and kept pursuing answers until I found out it was Lyme disease 4 months later. Three weeks of antibiotics only made my neuropathy and heart palpitations worse, so I continued to seek answers with other doctors as symptoms began to add up to include all of the following:

Heart palpitations

Stabbing pains in heart

Shooting pains in fingers, knees, teeth

Incessant eye twitch and other muscle twitches

Aching in jaw and cheekbones

Headaches, head pressure, head tingling

Constant nausea and general malaise

Blurred vision

Chronic sore throat

Internal body aches

Neuropathy / electric feeling in body when trying to sleep / internal trembling and vibrations when sleeping

Buzzing in feet

Back pain

Neck stiffness and shoulder stiffness

Insomnia/interrupted sleep

Strong fatigue

Occasional dizziness and vertigo

Brain fog

Skin inflammation

Anxiety and depression

Months of trying different medications, herbal supplements, and antibiotics did not solve the symptoms. This disease is a chronic illness if it is not caught within the first critical weeks of infection and causes people significant levels of pain and disability.

I would like to please ask that the TBDWG recognize and recommend a chronic designation of Lyme disease, to help all those suffering get the treatment and care they need. Accurate testing and effective, insurance-covered treatment is direly needed, especially as cases continue to rise each year.

Thank you for your time.

----

## Anonymous 8

I have been sick with Lyme for over 20 years.  I have spent many thousands of dollars on treatments and I continue to struggle every day.   It has affected my family, my career and my entire life.

People are sick. And, they deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified.

A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease.

We are seeking access to accurate testing, insurance coverage for this disease, employers recognizing that this is real.

We ask the TBDWG recognize and recommend a chronic designation of Lyme disease.

----

## Anonymous 9 

Thank you for allowing people like me to provide input on the subject of Lyme Disease and other tick-borne illnesses.

I live in Birmingham, Alabama and have been struggling with chronic Lyme and associated tick-borne infections for many years now. My list of symptoms is totally consistent with those of tens of thousands of other sufferers. It took me awhile to identify the cause, but through a lot of research and effort on my part and that of my husband, we discovered I had late stage Lyme disease. This has been confirmed by extensive and repeated testing, which we are paying for out of pocket. In the past, I contracted acute Lyme numerous times, with the acute symptoms including a bullseye rash, flu symptoms, aches and pains, etc.

Sad to say, most doctors in Alabama deny that chronic Lyme even exists. We saw numerous MDs, none of whom acknowledged Lyme as a potential cause, despite clear symptoms to the contrary and no other plausible explanation. We spent thousands of dollars on MRIs, X-rays, laboratory tests, scans, ultrasounds, etc., and they all came back fine. Lyme was discounted entirely. In fact, most doctors refused to even work with us once the word “Lyme” arose. So, we felt abandoned by the conventional medical community and began seeking other solutions. This story is a common one in the tick-borne disease community.

Lyme definitely exists in Alabama, though it is not as prevalent here (yet) as it is in many other highly endemic areas. I contracted Lyme in Maryland multiple times, but also here in Birmingham. Since our conventional doctors told us Lyme does not survive a standard 2 week course of antibiotics, we didn’t consider a persistent Lyme infection for a very long time. But, after years of suffering and a lot of research, we realized it WAS Lyme. Again, testing confirms it.

Since we could not find anyone willing or experienced in the treatment of late stage Lyme in Alabama, we decided to look out of state. We have relatives in Connecticut, and since it is a hotbed for tick-borne illnesses, we found an experienced doctor there. We were scheduled for an appointment on March 31, 2020...but, Covid-19 arrived and we had to cancel. Without care in Alabama, we felt stranded. It took nearly 7 months, but we were *finally* able to get approval from the state of Alabama for a TeleMedicine visit with our out of state doctor. Jumping through these hoops was a nightmare. While we are pleased to finally have a doctor willing and experienced in treating chronic, late stage Lyme, our insurance does not cover doctor visits, many lab tests, medications, etc. This has been a real financial burden, especially since my husband and I are both retired.

We have discovered numerous forums and associations dedicated to helping those with tick-borne diseases. Thousands, probably tens of thousands, of people are stranded, seeking whatever help they can find. These people are not imagining things, and the list of symptoms repeat over and over. Chronic, Post Treatment Lyme disease is REAL...it exists. Anyone who has experienced this devastating disease knows the frustration, expense, pain and stigma associated with this terrible disease. It can devastate one’s life. We need to acknowledge Chronic Lyme as a diagnosis, change our standard treatment guidelines, improve testing, provide better training to doctors, and make sure patients are covered by insurance. This disease is reaching epidemic proportions.

My symptoms include brain fog, difficulty with memory and speech, occasional confusion and forgetfulness, stiff neck and back, neck cracking, tingling and numbness in my extremities, pain in muscles and joints, sensitive and painful pressure points, occasional mild tremors, difficulty sleeping, chronic fatigue (I am in bed 11-12 hours at night and take a 2-3 hour nap most days, though sleep is often elusive), chronic constipation, upset stomach and belching, loss of libido, occasional blurry vision and ringing ears. Pains often migrate to different parts of my body and symptoms rise and fall somewhat like a roller coaster. Over time, my symptoms have gradually gotten worse.

Chronically ill patients deserve better than this. Please elevate tick-borne diseases to a higher level and help break down the current barriers to effective testing, treatment, insurance coverage and training.

Thank you for the opportunity to share my thoughts on this critically important issue.

Sincerely,

Anonymous

Birmingham, AL

----

## Anonymous 10

As a concerned father, I implore the Tick-Borne Disease Working Group (TBDWG) to support a chronic designation for Lyme Disease.  I have watched my daughter battle this terrible disease for over 10 years now.  Doctors with the expertise to treat Lyme are difficult to find and often require long distance relationships.  My daughter travels over 300 miles to another state to see her doctor.  The symptoms are many and manifest themselves in diverse and difficult to diagnose ways.  These “Whack A Mole” symptoms require a multitude of drugs, tests, and diets.  It is next to impossible to get any assistance from insurance companies that don’t recognize there is a problem anywhere but the northeast.  I have watched my daughter, who lives with us now, go to work so sick she can hardly hold her head up because she has prescription and medical bills to pay.  She has better days and she has worse days but hardly ever good days in the ten years with Lyme.  

Victims of this disease need access to accurate testing with insurance coverage.  More doctors are needed to make Lyme Disease their specialty. Employer, public, and doctor ignorance need to be addressed with information about how it is geographically widespread, lasting, hard to diagnose, chronic, and difficult to treat in any meaningful way. Without more focus on raising the awareness of this terrible disease we will be slow to see any progress with insurance coverage and identification and treatment with the medical world.  For these reasons we ask the TBDWG to recognize this need and recommend a chronic designation for Lyme Disease.  This would help ensure that countless Lyme victims would receive a proper and prompt diagnosis and treatment for Lyme and its many side effects.

Thank you, 

Anonymous

Versailles, KY

----

## Anonymous 11

I have a loved one devastated by Lyme disease and Coinfections.  It only takes just 1 tick bite to ruin a life.  First undiagnosed  for 7 years due to medical doctor ignorance everywhere. Then treatment to this day, its chronic, comes back after many treatments. Its been 12 long years of suffering, were not giving up. Emotional and financial cost are also enormous.

Here are just a few comments of medical doctors and infectious disease doctors, “there is no Lyme around here”, “you were treated, your over it now”, “go to psychiatry”. 

While some Lyme symptoms may be obvious, most are not.  **All medical doctors need to be required to do accurate testing for any child or adult who requires mood altering****drugs in there office**.  Local labs for Lyme and Coinfections only offer false negative results. Labs such as [redact] in California**, [redact] labs** in Germany offer accurate diagnosis.  I suggest you call this the **Lyme/Coinfection Law**, people and families have the right to know early that they have these terrible stealth bacterial infections.

Education and accurate testing is of upmost importance, please help us. I pray no one else becomes ill.

Sincerely,

Anonymous, Northwest Iowa

----

## Anonymous 12

I’m writing on behalf of the tick borne disease working group and as a long time Lyme sufferer. It’s time to put aside the stigma and old guidelines and  listen to the science. It’s time to listen to the people experiencing this illness. It’s time to have the funding for accurate testing to diagnose this illness and insurance coverage no matter how a person chooses to treat.  It will not only save money But stop the suffering. As a patient we need a chronic designation for Lyme disease.

My first hand experience includes over 8 yrs of not being  diagnosed and being misdiagnosed. Many unecessary tests not to mention the patronizing doctors that felt they knew my body better than me. The hospitals that didn’t know how to spell Lyme or have it in the system. The 3 times I almost lost my life. Shattered dreams losing my home due to excessive medical bills and being homeless for 5 yrs. im an educated professional that spent my life helping others and now I’m barely able to take care of myself at times. The stress of having to be my own doctor and researcher has set  me over the top.

I am writing this after spending 6 wks  in bed again after becoming very sick afraid alone and fighting for my life with little money. Noone  should have to go through this. We should have insurance coverage and choices of how we wish to treat. I’m allergic to most pharmaceuticals and would not survive using long term antibiotics so I have had to fundraise to try to get the help I need. When I don’t have enough money and I have to choose between eating or treating I have to eat. Please listen to the science snd to the people suffering.

Lyme sufferer

----

## Anonymous 13

TBDWG Representative,

Please vote in favor of the chronic designation for Lyme disease because:

People are sick. And, they deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified.

A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease.

We seek access to accurate testing, insurance coverage for this disease, employers recognizing that this is real.

I have been suffering from complications of Lyme’s disease for almost two decades and been fearful of being public about it. Though I had health insurance, I have spent over $100,000 in treatments to manage my symptoms myself. This expense and lack of medical acceptance lead to my divorce.  The symptoms strained my family and have limited my career choices. Why do I have to hide that I have this disease?

I ask the TBDWG recognize and recommend a chronic designation of Lyme disease

Anonymous

San Jose, CA

----

## Anonymous 14

To whom it may concern:

I had an imbedded nymph deer tick and the subsequent bulls-eye rash in August 1993 above my left knee.

I had had previous other deer ticks imbedded in me in Hayward, Wisconsin - where we vacationed every summer. But this was the first time I had ever had the bulls-eye rash. My husband took a photo of rash & my doctor scheduled an Appt to look at it.

I was treated by **[REDACTED].** He put me on 10 days of Doxycycline, believing that is all one needs to treat beginning Lyme tick bite.

My symptoms began w low-grade fevers that came & went and a left wrist and left knee that ached occasionally. I Also was diagnosed w interstitial cystitis in the following years. I tried to ignore the joint aches as much as possible, as one doctor said that at 42 yrs old, I was just ‘aging’.

In 2000, suddenly other symptoms hit, chronic fatigue, more joints on left side hurting - and constant pain rather than intermittent. And Intermittent brain fog. After seeking help from 11 different doctors and specialists - who all diagnosed me differently - I was Diagnosed with MUltiple Sclerosis, GERD acid reflux, Menieres Syndrome (incl vertigo & tinnitus) of the right ear, possible early Parkinson’s, tendonitis of the left foot (couldn’t bend left big toe and toe joints ached) and swallowing difficulties.

After 4 + years of this, I went to dentist for a root canal. He put me on a prophylactic prescription of 10 days Clindamycin and during this 10 days - literally ALL my symptoms disappeared! But 5 days after the end of the script, they returned.

I had another root canal scheduled - so I asked to be put on the preventative antibiotic again, and The dentist reluctantly agreed. Same result! The proof was there. Antibiotics helped my condition!

On Feb 9, 2004, I visited a Lyme-literate doctor who tested me w the western Blot (equivocal & positive) and treated Me with antibiotics. Antibiotic pills became a regular part of my life. I feel much better on antibiotics or after a course of them.

But I am not cured. I still need pain relief and Intermittent antibiotics just to function. It stole my teaching career & forced me into early retirement.

I firmly believe, though, without regular treatment, I would be either dead by now or permanently confined to a wheelchair.

So in 2020, I feel lucky to be alive to enjoy my grandchildren on days when I have less pain.

Sincerely,

Anonymous from Oregon, Illinois - now moved to Champaign, IL

----

## Anonymous 15

My 26 year old son [redacted] is suffering from many years of health complications due to Chronic Neuroborreliosis. 

Countless numbers of people are afflicted with this debilitating disease every year, many of whom go untreated for long periods of time which lead to further health complications accompanied by long and expensive treatment regimens that are often not covered by insurance companies. I have watched with my own eyes the deterioration of [redacted] health as we trekked from specialist to specialist at some of the most renown health facilities in the country including the likes of [redacted] and [redacted]. Despite relentless testing and different treatments, every doctor we saw eventually told [redacted] politely one way or another that he was crazy and that his symptoms were psychosomatic while [redacted] writhed in pain 24 hours a day, 7 days a week. He was tested for Lyme disease a number of times by different specialists and the tests all came back negative in which case the diagnosis for Lyme disease was ruled out. Little did I know at the time how poor the quality of testing truly was as most of these tests are sent to third party labs like [redacted] and [redacted]. The real shame is the culture of the mainstream medical community today that leaves doctors in the dark to how poor the tests they are ordering actually are. After exploring many different avenues of treatment for [redacted] and tens of thousands of dollars later, we came to the realization that the insidious pain he was dealing with could not simply be “all in his head”. 

The amount of pain and suffering [redacted] was dealing with had completely railroaded his life to the point he was basically bed-ridden and was forced to move back in with my husband and I. A once strong, college-educated, seemingly healthy young man with a bright future ahead of him was wasting away in pain with no answers. The severity of his pain even led to a hospitalization due to suicidal ideations because he could not see any path toward healing with no help from the medical community around him. Luckily, we had came across a doctor of integrative medicine during one avenue of treatment. After one hour of consultation and tests sent to special labs (like [redacted] in California) across the country and even parts of Europe was [redacted] finally diagnosed with Lyme disease with co-infections by CDC standards I might add. While this disease ravaged [redacted] health for years, specialist after specialist told [redacted] his pain was psychosomatic meanwhile a simple test of blood and urine at a minute fraction of the cost we had dumped into this journey finally proved that [redacted] was indeed very sick in May 2020. Not one doctor expressed that their testing may not have been accurate or recommended we look into labs with more specific testing. They rather proclaimed that there could be no way [redacted] has Lyme disease. Sadly, this case is not unique to [redacted] and as I have uncovered is actually the norm in many people’s journey with this disease. In fact, a significant portion of people go undiagnosed and cannot afford to see doctors that are willing to dive deeper into finding a diagnosis when inaccurate testing proves to be wrong leaving countless people left to suffer in the dark. Veterinarians across the country vaccinate animals to prevent them from contracting Lyme disease yet the medical community turns a blind eye to human beings whose lives are derailed due to this disease. 

The nature of this disease is not always visible to the eye which is another reason I believe insurance companies and the medical community at large continue to ignore the countless sufferers of tick-borne diseases. I also believe this is a big reason employers do not recognize that this disease is real. The negligence and lack of credence the mainstream medical community gives to Chronic Lyme disease can best be described as nothing short of pitiful considering people from all over the world come to the U.S. for our healthcare. Why would employers justify this disease when the medical community has turned a blind eye to it and its many sufferers?

Now that [redacted] is being properly treated for Chronic Lyme disease, most avenues of treatment are quite expensive and not covered by insurance. Treatment is not as simple as 4 weeks of antibiotics when the bacterium has compromised the patients health causing systemic issues that are difficult to treat. Had mainstream testing been more accurate, countless hours, days, and years of [redacted] and many others suffering may have been spared. There are a significant portion of people afflicted with health complications due to Chronic Lyme disease who do not respond to simple antibiotic treatment especially those who go undiagnosed for years. These people need help and there is substantial evidence that Lyme disease is the source of these people’s chronic debilitating symptoms yet insurance companies refuse to cover avenues of treatment because of the complexity of tick-borne diseases. [Redacted] is living proof that patients suffering from Chronic Lyme disease deserve more affordable treatments and those suffering from symptoms of Lyme disease deserve more accurate testing. 

Without the support of mainstream medicine and the insurance companies, this is nothing short of a crime against humanity. For these reasons, I plead to the TBDWG to recognize and recommend a chronic designation of Lyme disease.

----

## Carolyn Degnan

**Doctors Need to STOP “Gaslighting” Chronically Ill Patients!**

One of the biggest problems that chronically ill patients face is “gaslighting” from their physicians/practitioners.  I am familiar with that term when talking about a personal relationship but never heard it applied to a doctor/patient relationship until I heard it used during the 2020 LymeMind Conference. I was struck by how appropriate the term is to describe an abusive practitioner relationship.

**What is Gaslighting?**

Gaslighting is a form of emotional abuse that causes a person/patient to question their memory, perception and sanity.

“Gaslighting” in a personal relationship is usually when the abuser is a narcissist. The abuser denies, lies, minimizes, and undermines whatever it takes to plant seeds of doubt and confusion in the victim of his abuse.

When a physician practices “gaslighting”, the physician makes the patient feel like he/she is imagining their symptoms and then they tell the patient that he/she is depressed and needs anti-depression drugs. Gaslighting happens to many patient groups but it is most likely to happen to a female patient with chronic pain, Sickle Cell Anemia, Chronic Fatigue Syndrome, Lyme disease, and the list goes on and on.

The reality is that the patient is NOT crazy and not all physicians Gaslight--- but the physician who does Gaslight either:
                          - doesn’t know how to treat the patient’s symptoms/disease or
                          - has been taught by a national medical society to discourage and not treat this “type” of patient.

The only way for a patient to “win” is to walk away from that physician—but that also leaves the patient once again without any treatment and sometimes any hope of getting better.  It may be very hard for the patient to find another practitioner to work with them because the patient has been labelled as “difficult”.
                          - How do we help prevent “Gaslighting” for the patient population?
                          - Physician education about the disease is the key
                          - By empowering patients to know their rights to walk away from toxic physician relationships
                          - Encourage support groups for every disease
                          - Most importantly promote physicians who are caring and do not gaslight their patients.

LymeDisease.org strives to provide qualified Lyme Literate practitioners thru our **Physician Directory**. Many of the practitioners listed are members of ILADS (International Lyme and Associated Disease Society).  Others are listed at the recommendation of a patient based on their experience with the practitioner or are listed at the behest of the practitioner.  Information garnered from MyLymeData our patient driven research study showed that Lyme patients who improved substantially were treated by a Lyme Literate practitioner.  Being Lyme Literate doesn’t guarantee that the patient won’t be gaslighted but your chances improve significantly of having a positive experience if the practitioner is educated on the disease.

Carolyn Degnan, COO	San Ramon, CA	LymeDisease.org

----

## Ann Scofield 

Good evening to the members of TBDWG.  Thank you for your efforts to try to understand Lyme disease and Lyme coinfections on an infectious, treatment, and fiscal level.  I have read your prior recommendations and believe that you, in general, but maybe not at an individual level, are trying to do good where humanity is concerned regarding these insidious diseases.

I am a 43 year old woman from Fort Wayne, IN, who once was very vibrant and active.  My background is one of Science.  I have a BA in Biology and a Master ‘s of Forensic Science.  After grad school in 2002, I ended up working in Medical Laboratory Science.  I was pleased to be working towards an effort of helping patients get better.  My job was important on a human level.  There is nothing better than to serve your fellow human being.  This sentiment is an echo of what Jesus Christ taught us:   to “Love your neighbor as yourself.”  Matthew 22:39

I was only 25 when I started work at the hospital lab.  I was a generalist, so I worked in every area of the lab (Hematology, Micro, Blood banking, etc.).  I was very busy and the job required me to be speedy and clear thinking.  It was when I was training in 2002 that I got bit by a tick.  I wanted fresh air after a hard shift at the hospital, so I sat under a tree in my Dad’s backyard, and that is when it happened.  (I want to set the record straight about exactly how long an infected tick needs to be on you to cause Lyme disease and Lyme coinfections, because so many people in government and in medicine are spreading misinformation without questions to the veracity of their claims.  That tick was **not** on me for 24-48 hours!  I did **not** go to work with it on my left arm, leaving it on all night, only to come home and brush it off outside under the tree.  It was on me for a minute or less.  I felt the bite, looked down and saw the tick, and brushed it off.  What resulted was a bullseye rash a day or so after the bite).  Unfortunately, I did not seek medical help, and I paid for that decision.  Please stop the spread of the 24-48 hr necessary attachment time, misinformation!  It is deadly!

In that same year, I remember remarking to my Dad how tired I was, and that I should not be this tired at 25yrs of age.  I remember that I was having severe joint pain in my elbows, and I couldn’t tie it to anything.  I had forgotten about the tick bite, and would continue this lapse in memory until Spring 2016.  There were other clear signs I was very sick and in trouble.  The exhaustion continued, but got worse.  I was irritable and argumentative and that wasn’t like me at all.  I used to be very shy and never complained.  I had somehow gotten ill with a disease that was more rare back then; Sphincter of Oddi Dysfunction.  I had to undergo surgical shortening of the sphincter during ERCP, years apart from each other.  My belief is that since Borrelia burgdorferi can invade any organ, it did a number on that Sphincter, twice.  I started to get very anxious and I gained over 70 pounds, but had never experienced any anxiety in my life before or was ever overweight.  I started to see a psychiatrist who gave a lazy diagnosis of severe social anxiety, and was therefore branded as “mental” for years before the correct diagnosis was made on a systemic level.  I suffered with this unrelenting anxiety to the point I had to quit my career as a Medical Lab Scientist in January 2013 or 2014 (?), and I have been unable to return to any kind of employment since.

On November 15, 2015, I woke up and could not get myself out of bed.  I knew then that there was something frighteningly wrong with me.  My family doctor finally reviewed labs from the previous year and said that my hormones were all out of whack.  I had a clear case of hypothyroidism that went ignored, but I knew that wasn’t the end of it.

In March 2016, I went to see a Functional Medicine doctor who diagnosed me immediately with Mold sickness  (CIRS) and tested me for Lyme disease and Lyme coinfections.  In April 2016, she left a message on my answering machine that I was CDC positive for Lyme disease.  She started treatment in office, consisting of the usual: high doses of vitamins and supplements, antibiotics, and a change in diet.  I left her care and went on to get the same treatment in another office.  Nothing changed.  I wasn’t responding to treatment and I was “Herxing” or reacting, very badly to it.  I couldn’t withstand it. 

In 2017, I then sought expensive care at a clinic, spending over $100,000 for only 5 out the 12 prescribed weeks.  5 days a weeks for 5 weeks I received IV antibiotics, vitamins and supplements, chiropractic care and was told to go outside of the clinic to do detox treatments.  I had a very significant mental breakdown because I was pushed beyond what my body was capable of, even though I told them to slow down and told them how mentally anguished I was from treatment.  My Dad also put in several tens of thousands of dollars for my treatment, but we both would have gladly paid more if there were any chance of my recovery.  It was clear that wasn’t going to happen.

I sought treatment in the winter of 2017 in Indiana and have been with my current doctor since then, but consulted with 2 other physicians while seeing him, and am in the process of seeing yet another physician (that would be doctor #8) to see if she can finally help me get at least somewhat better.  I’m not ‘doctor shopping,’ I just want this nightmare to end.  My current doctor tried a number of antibiotic combinations with huge amounts of vitamins and supplements, and I’m still sick**.  I’m still sick**!!  If this isn’t **chronic**, I don’t know what is!  This is not Post Treatment Lyme Disease **Syndrome**.  That designation is false and is an insult to us in more than one way.

By not designating this as a chronic illness, we cannot get the kind of insurance coverage that other diseases get.  Why are we being barred from the care that we deserve?  Why should we go bankrupt trying to keep ourselves alive?  I’m out of money folks, and there are many like me.  It’s quite a shame that the IDSA, whom hasn’t met on Lyme disease policy since 2006, and the administrators at the CDC under the guidance of the IDSA, are directing the treatment standards for Lyme disease and Lyme coinfections and have kept the IgG and IgM Western Blot as their gold standard of testing, when its false negative rates sore upwards of 60%.  That is inexcusable!  If you’re not going to meet about the disease or let other scientists devise better testing methods (see Lee v CDC US Court of Federal Claims Case # 18-686C for 1 example of this), then you clearly don’t give a [redacted]. 

We, as citizens of this country, deserve better than what we have been offered.  The suppression of new technology to test for Lyme disease and the designation that it can’t possibly be chronic is nothing short of criminal.  The wrong people are steering the ship and it’s capsizing with every Lyme disease infected patient on board and many more to come.  There are no life boats for us.  It is up to you to enact change that protects this nation and world, because no one is immune or safe from being infected with Lyme disease and Lyme coinfections.  As an aside, if pandemics are being brought forth as a number one concern in this country, then the first pandemic, Lyme disease patients deserve just as much attention and financial support, if not more so, than COVID-19.

Good day and God bless,

Anne Scofield

Fort Wayne, Indiana

----

## Slater Harding Bland Lawrence

 Like so many thousands of patients with tick-borne illnesses, including Lyme disease, it took me two years to be correctly diagnosed. I saw literally every specialist, from neurologist to endocrinologist, and even went to the [redacted] (in 2015) where they dismissed my symptoms as simply autoimmune. This is partly due to the fact the IDSA and CDC claims that chronic Lyme disease is simply an auto immune disease if symptoms persists after 28 days of oral antibiotics (abx) - from meningitis to catching the tick bite early. Trust me, if I didn’t have Lyme disease myself,  I probably wouldn’t believe chronic Lyme exists either.

It is quite unfortunate because I don’t even use the term “Chronic” because of the stigma surrounding it, where people believe trippy, dippy hippies are using herbs in their basement. Lyme disease, along with co-infections contracted from the tick, are chronic. Borrelia burgdorferi, like tuberculous, (which treatment can range from 6-12 months, using, for example, rifampin), is a “persister” bacteria. It does not develop resistance to antibiotics like co-infections; rather, once leaving the blood stream, the spirochete (a cousin to syphilis) is a “tissue tropic disease” that literally drills into organs, like a corkscrew, to evade the immune system. This is why Lyme-literate doctors frequently implement “pulsing” of antibiotics, where they will introduce antibiotics for 2 weeks, and then take you off abx for 2 weeks to let the dormant bacteria come to the surface to be killed. Along with biofilms, where bacteria hides (gingivitis is a biofilm), and the fact that Lyme morphs into 3 different forms: cell way, intracellular and cystic (or round body) to, again, evade the immune system are additional factual explanations of why Lyme is so difficult to treat.

Lyme can attack any organ or nervous system - autonomic, central and peripheral - including the heart, the latter of which can kill you and has been widely documented.

I was serologically and CDC positive for Lyme on my ELISA and Western Blot. The CDC criteria for a “positive” Lyme test is 2 of the 3 IgM antibodies and 5 of the IgG antibodies. The problem with is that many, many people do not mount an immune response and, thus, no antibodies are present their western blot and are given a false negative. This is due to variety of factors, including the immune system being overwhelmed and not being able to mount an immune response.  I cannot tell you how many people I’ve met who had no antibodies present on their western blot until they take antibiotics, which stirs up the dormant bacteria, and consequently have a western blot that lights up like a Christmas tree.

Since most of my symptoms were neurological, I had 2 spinal taps to detect the bacteria in the cerebral spinal fluid (CSF). It is still extremely difficult to detect with a spinal tap, but fortunately my 2nd was positive for Lyme.

Following an MRI, PET and SPECT scan, my team of doctors learned I had a significant amount of inflammation in my temporal lobes, particularly on the left side. This region of the brain is responsible for word retrieval, speech, auditory processing, converting short-term memories into long-term etc. I was diagnosed with neuroborreliosis and encephalitis.

I cried when I received this diagnosis for several reasons. First, it perfectly explained all my symptoms and I finally received an accurate diagnosis. While I am an extrovert who works in communications, i could not recall words, put sentences together or follow the most basic TV. I literally could not process what was being said, e.g. on the TV, where it was like watching TV in another language. Secondly, I was right all along. I trusted my gut and was persistent even following the dozens of doctors who exclaimed it was “in my head,” or one doctor believing I had brain tumor after performing several tests. Lastly, after years of living in fear, and not knowing what was happening to me, I finally had a diagnosis and **what** I needed to fight and combat. It was hands down the best news I ever received.

In addition, I could not look at screens or drive a car because it was too much stimulation for my brain where the brain fog would become exponentially worse. I couldn’t even jog, because the natural up and down movements (with my head) from jogging were to jarring on my brain, creating the same aforementioned issues. Before treatment, I could not recognize very well-known scents. I could not recognize faces of the most famous celebrities. I developed depression and anxiety, both directly from the bacteria in my brain creating inflammation, but also the situation I found myself in: isolated. My back was up against the wall. My parents didn’t know what to do. I could barely research my symptoms because of my cognitive issues. I lost my sense of humor because I couldn’t think. My vagus nerve was also inflamed (part of the ANS) so breathing became difficult when standing, where my perfect 120/80 blood pressure would skyrocket. I developed terribly painful neuropathy in my feet and hands, where I had to buy new shoes that would fit.

The following 3.5 were hell. I had to quit my job. I had to break up with my girlfriend because I coudnt even take care of myself or get out of bed. I had already lost touch with all my friends because I became a shell of the person i use to be. I gave up my apartment and moved back home. The social, mental, cognitive and professionally ramifications of going undiagnosed was frankly cataclysmic and put my life on hold for ~5 years.

I am 30 years old now. I spent over $500,000 to treat lyme disease. Because of the CDC’s and IDSA’s guidelines that state there is no such thing as chronic Lyme disease, I paid for everything out of pocket. I paid $1,000/month just on probiotics so my clostridium difficile infection wouldn’t relapse. Each Lyme-literate doctor i saw, for the initial visit, ranged from $900 - $2800, where follow-ups where typically $500. I had PICC line for over a year, since the bioavailability of oral antibiotics isn’t sufficient to effectively penetrate they blood brain barrier. Intravenous antibiotics costs around $25,000 a month, out of pocket.

Just yesterday, I was on a Lyme zoom support group where we learned one woman had lost her house and had to move into a shelter to pay for her treatments. She can’t afford the dressing changes for her PICC line either, which also costs an exorbitant amount of money, so she has her mother coming to the shelter to change it. While I am extremely fortunate to have had resources to combat the disease, most people do not. I am further fortunate (and unfortunate) it happened in my 20’s when I didn’t have financial responsibility such as a child or mortgage. I have spoken with many individuals whose empathetic MD’s have had to put in different diagnostic codes for the insurance companies so their patients wouldn’t go bankrupt and their insurance companies would cover them. Irrespective of what critics may say, these doctors are absolute heroes and have saved lives and families.  

Lyme stole from my confidence consequently from the inflammation in the brain and all my neurological deficits. 12/2/20 will be my one year anniversary of being off all treatments, and while I am in complete remission, and have gotten myself and life back, I still worry on daily basis if the lyme will come back. In social settings or in an interview, will be able to be articulate and convey my thoughts?

Most importantly, however, Lyme took the one thing I can never take back: time. I missed the majority of my 20’s, when I should have be with friends, living on my own, dating etc. However, Lyme has given me one invaluable thing that I will never lose and will always hold dear: perspective. 

I am a very mainstream person - medically, politically - you name it. I faced every doctor and treatment with a healthy amount of skepticism because, as with everyone with Lyme, I had be my best own advocate. I knew people who became better with just antibiotics quickly, while most take years if they don’t catch it early. I also met dozens of patients who went the alternative route for a variety of reasons. Some regained their health while others continue to fight.

While had a robust amount of intravenous and oral antibiotics, I wanted to explore all options whicih led me to alternative treatments. Some worked, some didn’t. Though, I stuck with the ones I noticed improvement (trust me - not placebo kind of guy), even when I didn’t fully grasp how it worked. Unlike in more medically progressive countries like Germany, many of these treatments were not FDA approved so, again, I had to pay out of pocket, usually around $350 - $600 per treatment. There is no doubt there are some truly disgusting people who profit off the sick. Nevertheless, I was paying out of pocket because, again, CDC and Infectious Disease Society of America’s (IDSA) guidelines said there is no such thing as “Chronic” Lyme.

Fortunately, I moved back home in Westchester County, NY which is hot spot (along with New England and Wisconsin and Michigan), so virtually everyone I encountered or spoke with either had Lyme or knew of a family member, friend or friend of a friend who had a bad case of Lyme. I was more or less spared of the stigma outside of the doctors’ offices. Unfortunately, however, I have met and spoke with so many people on this journey (including people I had known) that didn’t reveal their health issues of chronic Lyme until i told them of mine, verbatum citing the “stigma” as reason they did not divulge this reason for fear of being seen as a “crazy” person. When people found out I had lyme disease, people came out of the woodwork to not only tell me their story, but also learn anything they could from me

In retrospect, the stigma is understandable, though not granted. Not because of its validity, but because it is due to ignorance; so many people who catch and treat lyme early can be successfully treated with 28 days of oral doxycycline so they believe that’s how all Lyme cases should turn out. Again, 98% of the population believes this disease strictly entails fatigue and joint pain and belive you only have lyme with the “bullseye” rash. In reality, the rash only appears in 50% of case. That is a fact.  Remember, this is not much different from COVID-19 in respects to a symptomatic perspective. Roughly ~9-11% of people in New England are positive for Lyme but are completely asymptomatic, and, thus, do not display any symptoms. 

We need funding for prevention, testing and treatment, all of which will help in informing the public, patients and doctors. Speaking with two friends who went to medical school at Weill Cornell here in NY and Emory in Atlanta, tell me they had 1-2 days on Lyme disease. Granted, if you decide to go into infectious disease that is much longer, but imagine how many internist (primary care physicians) are completely uneducated about the disease. This is compounded but he fact that many doctors went to medical school 10, 20, 30 years ago when there was comparatively no research on the disease. It is truly disheartening to see other infectious disease not only out funded lyme by 2-1, 3-1 or 4-1, but actually more like 20-1 and 30-1. Zika is an example of this. While it is a horrible disease, particularly on the newborn babies, lyme disease can have many similar effects. Though not as visible, equally, if not more, debilitating. Study after study demonstrate that lyme disease can easily pass into the placenta, where the child can then start life with lyme disease. Can you think of anything worse?

I implore whoever may have the opportunity to read this - read it **loud** and **proud**. Chronic Lyme is regrettably very real. I know too many people without the financial resources who must basically “live” with the disease - a neurodegenerative disease at that. In 2020, Americans, and all people, should not go bankrupt from fighting a disease; be shunned by their doctors; or become a social leper because they explain how they have “chronic” lyme disease.

Slater Harding Bland Lawrence

New York, New York

----

## Winifred Mauga 

Many verbal and public comments to the Tbdwg have asked for change in two things.  The two tier testing algorithm...and the Case Definition of Lyme be brought into a twenty first century perspective. 

It's convoluted to read reports like this from 2001.  Lyme was Bad then and it's worse now. 

https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-01-755/html/GAOREPORTS-GAO-01-755.htm

All committee members should google 'lyme and government involvement'  and it's sordid history.  Like this 2012 meeting.

https://www.help.senate.gov/hearings/lyme-disease-a-comprehensive-approach-to-an-evolving-threat

As always, Chronic aspects of lyme disease and testing reliability are an item of contention with Borreliosis. Let's face it... Dearborn was a fiasco in 1994.

https://cdmrp.army.mil/tbdrp/default

Are the patient shareholders gravely & grievously mis-represented?  After reading the following, I think so.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1265907/#__ffn_sectitle

It's been a laborious and mind boggling conundrum the Tick-borne disease working group has put patients through since it's inception. People deserve better.

In my next life I want is to be reincarnated into someones beloved pet considering how animals are treated more humanely than this committee is treating taxpaying vector-borne disease patients. 

This committee vexes us worse than an immuno-compromising OspA blebbing spirochete filled tick.

Respectfully,

Winifred Mauga

Citizen Scientist & Florida Grandma

----

## Global Lyme Alliance 

Dear Esteemed Committee Members,

On behalf of Global Lyme Alliance (GLA), thank you for the opportunity to contribute to the TBDWG’s effort to understand tickborne disease and the impact it has on public health. We appreciate your hard work and diligent discussions surrounding the science of this pernicious and expanding issue. Concerning Lyme disease, we respectfully urge you to consider its long-term impact on a significant number of patients.

Dr. John Aucott, a former member of the TBDWG and professor at Johns Hopkins University, and others have defined post-treatment Lyme disease (PTLD) as a model for persistent symptoms following Lyme disease diagnosis and treatment. Although this is a narrow definition, it nonetheless provides a useful working framework for evidence-based research.

Defining these patients has allowed us to understand, for instance, that PTLD patients have elevated inflammatory biomarkers like C-reactive protein1, increased serum cytokines like CCL192, and evolving antibody responses to VlsE protein3 of *B. burgdorferi*, compared to Lyme patients who have returned to health. We now understand that PTLD patients have antineural antibodies4 and suffer cognitive defects5. Thus, persisting symptoms in Lyme patients are correlated with quantitative and qualitative changes in biology. These studies, funded by grants from GLA, have all been published in peer-reviewed scientific journals. They pave the groundwork for further study of these patients.

Last year, GLA and Allison DeLong of Brown University published a mathematical model to calculate the cumulative total number of US patients with PTLD. As inputs, we used Lyme disease incidence data from the CDC and definitions from Dr. Aucott’s work. We took into account annual birth and death rates since the beginning of the Lyme disease epidemic, and estimated that up to ~2 million Americans may suffer from PTLD by the end of 20206.

These studies, while promising, are only a beginning to understand the science of persisting symptoms in Lyme disease. As you are aware, research in this area has not been commensurate with the large numbers of infected. Meaningful commitment of research dollars and effort are urgently needed to better diagnose and treat those suffering from long-term illness.

References

1. Uhde et al. (2016) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5106611/

2. Aucott et al. (2016) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5014924/

3. Chandra et al. (2011) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3183344/

4. Chandra et al. (2010) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2897967/

5. Keilp et al. (2019) https://pubmed.ncbi.nlm.nih.gov/30418507/

6. DeLong et al. (2019) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6480773/

----

## LymeDisease.org

We Need to Embrace All Forms of Evidence to Accelerate the Pace of Research in Lyme Disease

**Research Disadvantaged Diseases Create Research Engines Using Patient Registries**

Chronic Lyme disease is a research disadvantaged disease. Compared to other diseases very little clinical research has been conducted—particularly for the treatment of chronic Lyme disease where patients remain ill for six or more months following a short course of antibiotics. The National Institute of Health has funded just three clinical trial grants for the treatment of chronic Lyme disease.

Although Lyme disease is estimated to have over 400,000 cases per year, data from clinicaltrial.gov indicates that research for Lyme disease trails behind leprosy, which has an incidence of less than 200 cases a year (Goswami 2013). To date, pharma has shown no interest in developing new treatment drugs for chronic Lyme disease.

This means that even though it is not a rare disease, Lyme disease faces the same research challenges that rare diseases encounter. One way research disadvantaged diseases address their unmet needs is to build a research engine that facilitates and accelerates the pace of research by linking patient registries, biorepositories, and clinical data networks (Groft 2014). The NIH and the Patient Centered Research Outcomes Institute (PCORI) as well as the Agency for Healthcare Research and Quality have led efforts in this area. Dr. Francis Collins recently acknowledged the vital role that the patient led research in characterizing long haul COVID-19 (NIH Directors Blog 2020). Research in chronic Lyme disease needs to move forward at a much more rapid pace than it has historically. To do this it needs to take advantage of all forms of research, including observational research using patient registries.

**The MyLymeData Patient Registry and Research Platform**

In 2015, LymeDisease.org (LDo) launched the first national patient registry and research platform for Lyme disease, MyLymeData, which was developed as part of PCORnet, PCORI’s patient-driven research effort, when I served on its Executive Committee. I continue to serve as a subject matter expert in patient registries for PCORnet registries through the University of Chicago.

MyLymeData has enrolled over 14,000 patients, collected over 5 million data points, published five peer-reviewed studies, and seven white papers and scientific posters (Johnson 2011, 2014, 2016, 2018, 2019, 2020). It has been highlighted in two chapters in college text books and three government white papers on patient registries (Johnson 2019, Peay 2020). We collaborate with academic researchers at UCLA and the University of Washington as well as the Lyme Biobank, a project of the Bay Area Lyme Foundation. We just published our fifth big data study with UCLA researchers who received a National Science Foundation grant to explore artificial intelligence techniques using data from the registry.

**All Forms of Evidence Are Essential and Each has Unique Advantages and Limitations**

When the optimal treatment, duration, or combination of treatments is unknown, as it is in Lyme disease, the process of conducting back-to-back sequential randomized controlled trials to determine the best treatment approach is not realistic (Savor 2001). To accelerate the slow pace of research and to provide real-world evidence, observational data like those collected in patient registries hold enormous appeal for the type of detailed analysis essential to precision medicine (Kent 2018).

All data sources have their strengths and limitations depending on their source and characteristics. For example, randomized controlled trials are uniquely valued because of their ability to determine cause and effect, but they do so in a process that is inherently time intensive and expensive, typically measuring the effect of a single intervention at a time and generating knowledge sequentially. As one researcher noted: “It can take more than a decade for a trial to progress from the idea stage to actionable information, and cost and complexity mean that many questions will never be addressed with such trials” (Howie 2014). In addition, small exclusionary RCT trials, such as the NIH CLD treatment trials, are not generalizable to most patients seen clinically.

RCT trials often use average treatment effects from small, highly selective samples. Applying these results to the clinical population is problematic because of the lack of generalizability of these trials. Many clinical trials conducted in the US report on average treatment results, with some concluding that there is no treatment effect (Guyatt 2008). In essence, these studies are reporting on results for the “average” patient despite the variation in patient characteristics and outcomes seen in clinical practice (Kent 2018).

In contrast, patient registries reflect real-world behavior and practices and employ fewer inclusion and exclusion criteria (Dryer 2018). Studies with small sample sizes also preclude the type of subgroup analysis essential to identify treatment responders and only are able to detect large treatment effects (Kent 2018). Sample sizes in the thousands or tens of thousands are required to detect the small or moderate treatment effects that most patients would regard as meaningful (Guyatt 2008). Although a treatment may be clinically significant, the signal may not be apparent in a small study sample (National Academies of the Sciences, Engineering and Medicine 2017).

Because patient registries reflect real-world behavior and practices and employ fewer inclusion and exclusion criteria, they are more inclusive than randomized controlled trials and more generalizable to patients seen in clinical practice (Dryer 2018). They can also assess multiple treatment interventions used by clinicians in the real world and may reflect greater geographic diversity because they are internet based. Although patient registry samples are self-selected and rely on self-reported information, self-reported information is reported to improve accuracy of patient data and has been found to have acceptable levels of reliability when compared to medical chart information (Dryer 2018).

Similarly, convenience samples drawn from clinicians may have inherent sample bias reflecting the geographic location of the office as well as the treating style of the physician (and whether patients select to be treated by the physician). Insurance databases are broad but are limited to the data they collect and only include those whose treatment is covered by the insurance plan. (Many Lyme patients report that their physicians do not accept insurance.) Electronic health records may be limited by their intended utilitarian focus (billing claims).

Some of the strengths and weaknesses of different evidence bases are summarized below.
                          - Randomized Controlled Trials:		                             - Strengths: Well characterized samples; rigorous methodology; can demonstrate cause and effect.
                            - Weaknesses: Often small restrictive, exclusionary samples which may not be generalizable to the patients seen in clinical practice; often rely on treatment response averages that mask heterogeneity of response; expensive; take a long time to recruit and conduct 
                          - Insurance Claims Data		                             - Strengths: Ubiquitous; large samples; standardized data; may include prescription information.
                            - Weaknesses: Insurance covered care only; no clinical assessment of “results” (e.g. clinical improvement); not-specific; not timely 
                          - Academic case data from Electronic Health Records		                             - Strengths: Well characterized samples;  rigorous methodology; lab measures; assessments (Results)
                            - Weaknesses: EHR siloed; physician time constraints; practice constraints limiting available treatments; EHR records are designed for billing purposes; convenience sample 
                          - Community Clinical Data		                             - Strengths: Real world clinical care; N-of-1 practices; lab measures
                            - Weaknesses: EHR siloed or paper/non-existent; physician time constraints; convenience samples; clinician treatment preferences. 
                          - Patient registries		                             - Strengths: Real world clinical care; standardized questions; timely; labor burden on patient; ability to gather data from many sources (e.g. different providers)
                            - Weaknesses: Self-selected sample; patient generated data; cannot demonstrate cause and effect. 

The bottom line is that each form of evidence is vital in research despite the limitations inherent in each. Often ground truth is established when different forms of research evidence produce corroborating findings. Patient registries play a critical role in characterizing a disease, assessing real world treatments used in clinical settings, evaluating the effectiveness of different standards of care, and documenting treatment side effects. As such, they should be a central part of the research tool kit to improve patient care in Lyme disease.

**References:**

Bayliss, M.; Rendas-Baum, R.; White, M.K.; Maruish, M.; Bjorner, J.; Tunis, S.L. Health-related quality of life (HRQL) for individuals with self-reported chronic physical and/or mental health conditions: Panel survey of an adult sample in the united states. Health Qual. Life Outcomes 2012, 10, 154.

Biau, D.J.; Kernéis, S.; Porcher, R. Statistics in brief: The importance of sample size in the planning and interpretation of medical research. Clin. Orthop. Relat. Res. 2008, 466, 2282–2288.

Bytzer, P. Assessment of reflux symptom severity: Methodological options and their attributes. Gut 2004, 53 (Suppl. 4), iv28–iv34.

Cohen, D.J.; Keller, S.R.; Hayes, G.R.; Dorr, D.A.; Ash, J.S.; Sittig, D.F. Integrating patient-generated health data into clinical care settings or clinical decision-making: Lessons learned from project healthdesign. JMIR Hum. Factors 2016, 3, e26.

Collins, F. Patient led research: Citizen Scientists Take on the Challenge of Long Haul COVID-19. https://directorsblog.nih.gov/tag/patient-led-research/

Delong, A.K.; Blossom, B.; Maloney, E.; Phillips, S.E. Antibiotic retreatment of Lyme disease in patients with persistent symptoms: A biostatistical review of randomized, placebo-controlled, clinical trials. Contemp. Clin. Trials 2012, 33, 1132–1142.

Dreyer, N.; Franklin, P.; Haynes, K. Direct-to-patient registry and other patient-centric designs. In 21st Century Patient Registries: Registries for Evaluating Patient Outcomes: A User’s Guide, 3rd ed.

Goswami, N.D.; Pfeiffer, C.D.; Horton, J.R.; Chiswell, K.; Tasneem, A.; Tsalik, E.L. The state of infectious diseases clinical trials: A systematic review of clinicaltrials.Gov. PLoS ONE 2013, 8, e77086.

Groft S. Patient Registries as a Prelude to Clinical Trials and Post-Approval Studies;. In Proceedings of Pediatric Devices for Rare Diseases Food and Drug Administration White Oak, Maryland, January 8, 2014.

Guyatt, G.H.; Mills, E.J.; Elbourne, D. In the era of systematic reviews, does the size of an individual trial still matter. PLoS Med. 2008, 5, e4.

Howie, L.; Hirsch, B.; Locklear, T.; Abernethy, A.P. Assessing The Value Of Patient-Generated Data To Comparative Effectiveness Research. Health Aff. 2014, 33, 1220–1228.

Johnson, L.; Shapiro, M.; Stricker, R.B.; Vendrow, J.; Haddock, J.; Needell, D. Antibiotic Treatment Response in Chronic Lyme Disease: Why Do Some Patients Improve While Others Do Not? Healthcare (Basel) 2020, 8, doi: https://doi.org/10.3390/healthcare8040383.

Johnson, L.; Wilcox, S.; Mankoff, J.; Stricker, R.B. Severity of chronic Lyme disease compared to other chronic conditions: a quality of life survey. In PeerJ, Wilke, C., Ed. 2014; Vol. 2, p e322.

Johnson, L.; Shapiro, M. Delayed Diagnosis Linked to Persistent Lyme Disease. (figshare). LymeMind Poster Session 2019, https://doi.org/10.6084/m9.figshare.9947105.v1.

Johnson, L.; Smalley, J. Engaging the Patient: Patient-Centered Research; Hall, K., Vogel, A., Croyle, R., Eds.; Springer: Switzerland, 2019; Vol. Chapter 10, pp. 507.

Johnson, L.; Shapiro, M.; Mankoff, J. Removing the Mask of Average Treatment Effects in Chronic Lyme Disease Research Using Big Data and Subgroup Analysis. Healthcare (Basel) 2018, 6, doi:10.3390/healthcare6040124.

Johnson, L.; Mervine, P.; Potter, M. New patient-powered research tool can be used to answer important questions about Lyme disease. In Proceedings of the Poster Presentation at the LDA/Columbia Conference, St. Paul, MN, USA, 16 October 2016.

Johnson, L.; Aylward, A.; Stricker, R.B. Healthcare access and burden of care for patients with Lyme disease: a large United States survey. Health Policy 2011, 102, 64-71, doi:10.1016/j.healthpol.2011.05.007.

Kent, D.M.; Nelson, J.; Dahabreh, I.J.; Rothwell, P.M.; Altman, D.G.; Hayward, R.A. Risk and treatment effect heterogeneity: Re-analysis of individual participant data from 32 large clinical trials. Int. J. Epidemiol. 2016, 45, 2075–2088.

Kravitz, R.L.; Duan, N.; Braslow, J. Evidence-based medicine, heterogeneity of treatment effects, and the trouble with averages. Milbank Q. 2004, 82, 661–687.

National Academies of Sciences, Engineering, and Medicine. Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop; The National Academies Press: Washington, DC, USA, 2017.

Peay, H.; Cope, E.; Horn, E.; Faulkner, M.; Carton, T.; O'Boyle, M.; Johnson, L. Building the Proper Foundation: Governance for Stakeholder-Engaged Research; Zimmerman, E., Ed. Sage: Virginia Commonwealth University, 2020; Vol. Chapter 17, pp. 477.

Saver, J.L.; Kalafut, M. Combination Therapies and the Theoretical Limits of Evidence-Based Medicine. Neuroepidemiology 2001, 20, 57–64.

Wood, W.A.; Bennett, A.V.; Basch, E. Emerging uses of patient generated health data in clinical research. Mol. Oncol. 2015, 9, 1018–1024.

----

## Calysta Gerhart 

My name is Calysta Gerhart. I have been living with chronic Lyme disease for the past 14 years. 

It has been a nightmare, at times, trying to find a doctor with up-to-date knowledge to treat, or even finding a doctor who would even acknowledge that a diagnosis of Lyme could be a possibility since I reside in Tennessee.  I was told numerous times that there is no Lyme to be found in the area of the country you're in!  Of course, this is not true!

Even after going through extensive treatments and rounds of antibiotics, I still suffer with brain fog, some days worse than others.  I deal with horrible inflammation of joints and reoccurring migraine headaches.  Lyme has caused thyroid issues that I deal with daily.

None of this is covered by insurance.  The expense is all out of pocket for the physician, labs, meds, and numerous supplements that are needed to help keep my body functioning.

Many individuals are suffering with Chronic Lyme and are needing easier access to Lyme Literate Doctors who can help them regain their health.  More convenient testing needs to be available to quickly diagnosis patients so that it can be recognized early and treatment initiated.

Thank you for any assistance and awareness that you can give this important subject.

Calysta Gerhart

Sparta, TN

----

## Paul B. Ross 

I understand that the TBDWG is scheduled to vote on a chronic designation for the 2020 report to the HHS Secretary and Congress at the upcoming meeting on November 17.

As a sufferer of Lyme and several co-infections for the past 16 years, and who remains disabled as a result, I implore the working group to designate Lyme and its co-infections as a chronic illness.  People like myself have been genuinely ill for years from these infections.  We deserve better than being stigmatized by physician ignorance and public shaming.  It is imperative that those who have been battling such illness be provided with insurance coverage.  Too many people sick from these infections have been denied such coverage based on a falsehood that Lyme and co-infections is an acute illness that can be properly eradicated with a short course of antibiotics.  Such thinking has been demonstrated repeatedly to be patently false.

In addition, a chronic Lyme designation should move the federal government and its agencies like the NIH and CDC to allocate more money for research so that sooner rather than later patients can benefit from a yet to be developed accurate diagnostic test and specifically tailored treatment. 

It is an atrocity that millions of Americans are suffering needlessly because a faction of doctors, mostly in the research community, are clinging to the falsehood that this is not a chronic, intractable and growing public health problem.  Accordingly, please designate Lyme as a chronic illness at your next meeting on November 17.

Respectfully,

Paul B. Ross

Merrick, NY

----

## Sonya Gregory 

I am sick.  Many many people are sick. And, we deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified. A chronic-Lyme designation will  ensure that countless Americans are provided proper diagnosis and treatment of this disease. We are seeking access to accurate testing, insurance coverage for this disease, employers recognizing that this is real. We ask the TBDWG recognize and recommend a chronic designation of Lyme disease.

It is the most cruel thing to be so sick and have to beg for help.  It is a crime against we who suffer with lyme disease and our families, to be denied proper diagnosis and treatment.  It should be punishable by law that insurance coverage is denied to us for proper diagnosis treatment. 

Please hear our cry for help,

Sonya Gregory

Lattimore, NC

----

## Rose Anastasio

To the TBDWG:

I am asking that you recognize and recommend a chronic designation of Lyme disease.

After seeing 10 doctors and  2 1/2 years later, I was finally diagnosed with Lyme disease in 2004. That was 16 years ago. Since then, I have continued to battle this disease. I’ve been on 5 separate courses of antibiotics and countless other drugs and supplements. It has never gone away. I continue to suffer. Had I been properly diagnosed at my initial visit, which was one week after being bit by a tick, my lyme disease could have been eradicated. Two western blot tests done at separate times, came up negative.  If we had updated and accurate testing, I would not have had to endure countless doctor’s visit, as well as unrelenting pain and fatigue, for the past 15 years. Additionally, I have personally spent over $100,000, trying to heal my body.

The lyme community seeks access to accurate testing, insurance coverage for this disease, and employers recognizing that this is real.

People are sick. And, they deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified.

A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease.

Thank you,

Rose Anastasio

Lyme advocate

----

## Emily Bailey

Hello. Thank you for taking the time to read my comment. I was bit by a tick in 2015 in Ohio and started having symptoms within a week. Local doctors claimed Lyme didn’t exist here. I had 2 positive high Elsa tests, but my western blot at first was negative (missing 1 band to be CDC positive). I have Lyme and with a known bite doctors should have KNOWN to treat. I’ve since tested positive for Lyme and multiple co-infections the tick also gave me. I was misdiagnosed for over a year and now I’m sentenced to a life of chronic Lyme and mistreatment from doctors who don’t know barely anything about my illness, bc local doctors wouldn’t give me 4-6 weeks of antibiotics in the beginning.

People, including myself are extremely sick. We deserve better. We deserve real treatments and doctors to be informed. We deserve to be heard. We deserve for insurance to pay for our treatments. We deserve reliable testing, not testing that is outdated from the 70’s. Please stop ignoring us. We are suffering and people are slowly and painfully dying. So many are sick. Beyond sick. Disabled due to this horrific disease. Go to any Lyme board on Facebook and see the devastation. It’s so beyond sad.

So many are suffering and something has to change. Please I’m begging you, just help us. I’m in tears as I write this. The suffering is unimaginable unless you have experienced it. Years of nothing but pain and suffering. We never feel good. Our lives have been stripped from us and then we have been denied and treated like it’s not real. This has to stop and now, please just help us! Chronic Lyme or long term Lyme or whatever you want to call it, is very real and we deserve for that to be recognized.

Thank you for your time.

Thanks,

Emily Bailey

South Point, OH

----

## Brenda Elmer 

Hi my name is Brenda Elmer in 2010 I was diagnosed with Lyme Disease. I spent a total of one month in 3 different hospitals at the time, when I was finally discharged I had a Pic line and was being treated with Rocephen by the pic line . I received 28 days of treatment at this time. I still continued to experience symptoms of Lyme Disease long after the treatment. Example of what I am speaking about when I was discharged from the last hospital with the pic line I could walk fairly well with a walker within less than a year I was using a motorized wheelchair and leg braces my life was destroyed. I spent 5 years in that wheelchair but with help from a doctor that understood Lyme Disease I am now able to walk most days without assistance but still use a walker when going out in the community. The leg braces are gone. But I know that getting doctors to believe and understand that this was caused by Lyme Disease is very hard if not near impossible because of the CDC s take hard to catch, and easy to cure, Lyme Disease is nothing like that and it is about time the public knows that!

Sincerely, Brenda J Elmer

----

## Michael Connelly

I am asking the TBDWG to recognize and recommend a chronic designation of Lyme disease.  I am also asking that there be accurate testing and insurance coverage for this disease as well as employers recognizing that this disease and its chronic symptoms are real.  Chronic Lyme is real and we deserve proper diagnosis and treatment for this disease because much doctor ignorance is prevalent as they will brush it to the side or ignore the possibility. 

I have had Lyme disease since 1984 which at that time no one even knew it existed in many parts of the country,  I never knew that a tick had bitten me and could not recognize the telltale bullseye because this had never happened to me before.  Doctors at that time told me I had rheumatoid arthritis or scarlet fever neither of which gave me any reason to believe this.  I was 33 at the time and certainly this does not happen overnight with either diagnosis.  I felt as though a truck had run over me as nearly every joint in my body had excruciating pain which lasted for weeks.  Had some of the treatments they have today been available I may not have had to live through 36 years of this disease.  To this day I have episodes that will attack many of my joints randomly and with no time frame.  I may have these episodes every 3 months or once every 6 months or once every year.  The pain is excruciating and disrupts my life for many days to weeks.  I just had both of my feet and ankles swell so much that I could not even walk on them for many days as the pain felt as though nails were everywhere on the bottom of my feet and this happened again 2 weeks later and no it is not gout as this was eliminated.  I have had both my knees affected as well as my shoulder along with fingers and elbows many times since my initial tick bite.  These symptoms develop in a matter of hours and last 3 days, 5 days or weeks and then they just disappear.  Damage to these joints  have been a lasting result.

The idea that this is in my head or must be my lifestyle that is causing this is absurd.  Many doctors are extremely illiterate on Lyme and many do not listen to you about the chronic symptoms that do reoccur.  I live a very healthy lifestyle within reason and do not have any other conditions besides arthritis which gets accelerated when the Lyme symptoms do come back but am not disabled or unable to live my life because of the arthritis. I have given up even mentioning these events to my many doctors I have had because they just listen and move on.  This chronic part of the Lyme disease is real and even happens to many people who have had the treatment early in the disease.  The problem is that many thousands of people didn't know they were bitten or didn't have the initial treatment and are suffering greatly.  I have it mainly in my joints which are the same as initial symptoms but there are people with nerve damage or brain damage or constant exhaustion who can't live a normal life because there is no cure.

I really need your organization to designate this as chronic-Lyme because it definitely does exist.  This bacteria will float in your body and then decide to attack my joints in a manner that debilitates me for many days and doctors can't give me any relief because they don't know how or do not have the drugs or do not care.  This has to be remedied.  Thank you

Michael Connelly

Oconomowoc, WI

----

## Eve Marcus

I'm a volunteer Lyme disease educator with the [REDACTED] system, Oxford Ohio branch.  We've discovered a great deal of denial of Lyme disease in the greater Cincinnati area.  Too many people are only  diagnosed in later stage Lyme disease, having endured much suffering and physical damage.  A chronic Lyme disease designation would ensure that Americans, (and travelers to our shores) are provided proper diagnosis and treatment.

Eve Marcus

Cincinnati, OH

----

## Erik Ferjentsik

I am writing this public comment to ask that the TBDWG recognize and recommend the chronic designation of Lyme disease. I have been suffering from late-stage Lyme disease for 8+ years now. I have emptied my wallet to pay for treatments out-of-pocket, because insurance doesn't recognize chronic lyme disease thanks to the disease not being recognized by the TBDWG, CDC, and other gov't health bodies.

I almost died in the emergency room with Lyme Carditis after 4 years of battling this horrific disease. I took well over the 3 weeks of doxycycline that the CDC incorrectly states is a cure for Lyme. That along with many other treatments over the years. How could I almost die from a disease 4 years after being diagnosed that isn't recognized as a long-term chronic illness? That makes no sense.

There are millions others with similar stories. It's a direct insult to me and all those suffering to deny, miscategorize, downplay their illness when it's clearly present and medically life-changing....or should I say life-ruining. I know people who've had/have cancer and Lyme and state undeniably that Lyme is worse than cancer....yet the disease gets no recognition and very little funding in the way of improving testing and treatment. This is an abomination and inexcusable.

Lyme patients are sick and dying of the disease, or committing suicide, because they go broke trying to treat it on their own and run out of money along with the will to live. We all deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified.

A chronic-Lyme designation would help pave the way for ensuring that countless Americans are provided proper diagnosis and treatment of this disease. Please, I beg you, do the right thing here and provide us the recognition we need to start fighting this disease with the proper channels.

Kind regards,

Erik Ferjentsik

Monroe, CT

----

## Dave Birren

Greetings,

I am writing with regard to the need for a chronic Lyme disease designation by the TBDWG.

People who suffer long-term Lyme disease symptoms are referred to as having PTLDS - post-treatment Lyme disease symptoms.  There is no designation for those who have long-term symptoms but have not received treatment.  In both cases I believe it is appropriate to designate them as chronic Lyme disease.

I was first infected in 2006 and had a variety of muscle and joint problems as well as deep fatigue.  After a few months all that was left of that was an arthritic neck.  Testing for Lyme disease was negative.  Fast-forward nine years to 2015.  The day after surgery for a-fib I was hit with a variety of baffling symptoms.  Those symptoms were highly consistent with Lyme disease: dizziness, fatigue, paresthesia (peripheral neuropathy), rashes, multiple joint inflammation, vision issues, hair loss, and a few other minor issues.  An ELISA test was negative (that was no surprise, considering that test is only about 50% accurate).  Eventually, I had a positive Western blot test that confirmed the clinical diagnosis.  I have had several rounds of different antibiotic treatments with inconsistent results.

It is now late 2020 and I continue to suffer dizziness, fatigue, bleary eyes, shortness of breath, and occasional paresthesia.  This condition is clearly chronic, and with both clinical and serological support for a diagnosis of Lyme disease, I believe it is appropriate to call it chronic Lyme disease.  The fact that I have had treatment - regardless of its effectiveness - does not change the fact that my condition is chronic.  I would be in essentially the same boat with or without treatment.

The problem may be in my brain, but it isn't "all in my head."

Thank you,

Dave Birren

----

## Eve

Hello,

Thank you for the opportunity to share my personal experience with Lyme disease.

Here are some things I have experienced.

1. Doctor ignorance and shaming!

This has been horrendous. My path:  I suffered with health issues for years without being taken seriously by allopathic doctors. I struggled with chronic fatigue, headaches and foggy brain, joint pain, chronic pain, allergies, etc. The doctors  would do a basic test or two, such as check my blood counts. When these came back in the normal range, they would dismiss me. They would not do any other testing or spend anymore time trying to help me. Do you know how horrible this feels? You are helpless. Especially if you don’t have a lot of money or health insurance.

Consequently, the quality of my life has suffered for years.  I now also have Lyme arthritis, tinnitus, my bones hurt,  my nervous system is damaged to where I can’t be around bright lights, loud noises, chaos. My vision looks like I am wearing glasses with dirty lenses, but I am not wearing glasses. I have been unable to work full-time for years because I get so sick that I am literally crying at work and lying down to rest instead of eating during my lunch break. This inability to work full-time then impacts my finances and  my health insurance. It becomes a horrible, depressing loop. When I do get home from work, my body is done for the day, exhausted, starting to feel sick. All I can do is go to bed until it’s time to get up to get ready for work the next day. It is a depressing way to live. And yet the only allopathic doctors that will help me are ones who are Lyme-literate and trained by ILADS.

At some point a non-traditional doctor told me he suspected I have fibromyalgia. For years I thought this was it. The treatments suggested my allopathic doctors did not help. The only thing that did help me function was the tramadol they gave me for the chronic pain.

When I was finally diagnosed with Lyme disease, it was with the non-traditional BioSet-type of testing. I am so grateful for this doctor, as finally, after years of ill-health, I had an accurate diagnosis. The test came back positive for Borrelia Burg., Bartonella H., Erlichia Senn., and 2 types of Babesia, The treatment that he gave me was making me herx. At the time, I did not know about this process.

I wanted to get tested from [redact] to verify this test. This requires a doctor to request it.

I did not have health insurance and the only place I could go was **[REDACTED]** in Kansas City. The doctor agreed to a PCR test in their lab, which came back negative. When I read about this test, I learned that it is 99% accurate **IF there happens to be borrelia in that tiny sample of blood**. But the nature of the borrelia organism means it’s quite likely there will be no borrelia in that particular sample and yet you can still have it in your body. It’s not an accurate, definitive test.

I made another appointment to request testing from [redacted]. I was so sick from herxing, i was crying in the waiting room, and I had to lie down on the exam table when in the exam room.  I was seen by a resident. As soon as he saw the negative PCR from [redacted], he dismissed me. I argued with him that I wanted to do [redacted] testing. After leaving me in the room for awhile, he returned with the head resident. **This doctor had already diagnosed me with hypochondria before he even saw me.**He was arrogant, rude, dismissive. He insisted that PCR testing for Lyme is 100% accurate and definitive, when it is not. He stated there is no Lyme disease in Missouri, which is also not true. He stated that he is happy to help me by setting up an appointment with a psychologist.  Period. End of conversation.

(I have all these records and names, but not the time to dig them out.)

OMG. It was horrendous. At this point in time I had read**[REDACTED]**books as well as other research on Lyme disease and was armed with information. I wrote a lengthy complaint with the hospital. This resulted in the head doctor for this clinic to agreeing that I could get some [redacted] testing. (This I said all along I will pay for myself, and I did.)

She also made me an appt. with a doctor in their **[REDACTED]**to go over the results and speak with. I was told my staff in the**[REDACTED]**that this doctor is very thorough and I should be prepared to spend 2 hrs.with him. I was so excited.

I was only able to afford a few test at [redacted]. I had the results with me when I saw this doctor. Negative: West Blot; Positive: IFA for borrelia, Positive: FISH for Bartonella, CD-57 abosolute count of 20.

The doctor made me wait FOUR HOURS past my appt. time! I had not taken any pain medication that day, so he could better evaluate me. At some point in waiting, the pain started coming. I consulted on of the nurses, and she suggested I tough it out, so he could exam be more accurately. The pain got so bad that I was curled into a ball on my chair, rocking back and forth and crying.

When i finally saw the doctor, he was totally dismissive. He hadn’t even looked at my test. He had a resident in the room who had the test in her hands. She insisted that I tested negative for Lyme, when my IFA was positive. So was my Bartonella.

This ‘expert doctor’ told me that many people test positive for Bartonella, and that doesn’t mean a thing. He also patted me on the head and said, ‘Some labs just get funny results.’

That was my appointment. I consider that malpractice. It was also emotionally devastating when you are horribly sick. I was too sick to expend the energy on fighting this system, so I made an appt. with a Lyme-Literate practitioner ref.by ILADS. This person wanted to start with several tests. I still did not have health insurance, so I went back to **[REDACTED]** to see if I could have the tests done there. The person I saw with the first appointment did this.

But the next appointment, I was told she was wrong, and no, they will not do any more of the tests requested.

I was so angry with **[REDACTED],**and much more educated about Lyme disease. Among other things, I now knew that it is COMMON for Lyme sufferers to be dismissed by their doctors as hypochondriacs. I wanted to file a complaint and try to educate them. But as they now had the name of my Lyme-literate practitioner, I had to just keep my mouth shut, as I had learned how  the AMA has a history of coming after doctors who treat chronic Lyme patients. I wanted to protect my doctor and dropped any thoughts of fighting for just health care.    

Work and Life Quality.

I’ll make these brief:

For years, my life has consisted of going to work, then coming home and going to bed until it’s time to get up for work then next day. I am single. This makes it impossible to date and create a relationship. The isolation is unhealthy. My home piles up with undone tasks. It’s very depressing, yet I fight to keep my spirits up and to heal.

About 18 mo.ago, I tried a full-time desk job, thinking that may be ok. But it wasn’t. It was too much for my body and I felt sick...like when you have a cold or flu and just need to lie down. This happens to be when I push myself.

I am self-supporting. I need the health insurance. I need to be able to pay by bills and keep a roof over my head. I had to make it thru 3 months of training at full-time before I could request to lower my hours. Once thru the training, it took months of fighting and jumpging thru hoops and contacting whoever I could. I was so sick. I was hanging on by my fingertips. My manager told me he could tell that I really was sick. There were days when I cried at my desk because I felt so horrible. But I needed this job.

Finally, it was the union that saved me. And the fact that the top manager of our building, the person who made the final decision on whether I could lower my hours, has a niece who suffers from Lyme disease. She is a nurse and is only able to work two days a week. I am so blessed that this is the person who made the decision. I don’t know what I would have done if they had disallowed me to lower my hours. I may very well have ended my life. I just so sick when I over-do it. And working full-time is too much for my body while dealing with Lyme disease.

This is a boring job where I am processing paperwork all day. But there are limits on what jobs I can do while working 30 hrs.per wk. This job has many people doing the same job. So it doesn’t really matter if I work 6 hrs or 8 hrs. I requested to work 6 hrs per day, as this was the very minimum I could work and still survive financially.

Unfortunately, when I lowered my hours, my health insurance premiums rose.

Doctors and Testing

All Lyme-Literate doctors have to be very careful due to the current stance of the CDC. No of them are in any health insurance networks. I have to pay upfront for my doctor visits, which are $250, and then submit to be reimbursed 50% by my health insurance co. I also have to pay upfront for any testing that is out of network, and hope that I get my 50% reimbursement for these, too. It’s very expensive, especially when you are working 30 hrs./week.

It would help immensely if the CDC would recognize chronic Lyme. If health insurance covered testing at the labs that specialize in Lyme disease, such as [redacted], etc.

Ok. Out of time. Thank you and please take chronic Lyme Disease seriously. It is destroying so many lives. It’s bad enough to be sick, but when doctors refuse to help you, it’s unbearable. Thank God for the researchers and doctors who listen to science, and listen to their patients and are helping them to regain their health.

Eve

Kansas City, MO

----

## Rob Murray

I am a retired dentist and had a tick bite in the spring of 2012 and an E.M. rash which unfortunately I didn’t recognize. A year and a half later I went to my family physician with the complaint that I felt that I was walking around in a 100 year old body and discussed Lyme disease a possible diagnosis. The ELISA was negative and that he told me was as far as he was allowed to go. He did test me for everything else and this to was negative - but that was the clue and just another layer as I circled in on the true diagnosis. The test for Lyme disease is reliably inaccurate and should be scrapped because it is what has gotten us into all this trouble. Early in my journey I started off with a misleading video [redacted] in which they had looked everywhere but couldn’t find anything wrong with these people and hoped somebody [else] would find out what was really wrong with them. It turns out most stories are similar starting with a tick bite and then coming to the conclusion that patients have a mental illness, medically unexplained symptoms or fibromyalgia etc. I found more of the same misleading dogma on the ADLF web site the IDSA’s front organization that uses the same successful tactics as the "Merchants of Doubt" have done for the tobacco and fossil fuel industries. Physicians are all too willing to pile patients onto the compost pile of psychiatric disorders. I personally knew 3 people that have died from neuro Lyme and one that committed suicide from medical denial and neglect. The paradigm of modern medicine is to palliate. It’s hard to solve a problem that medicine won’t admit to. It’s time medicine got back to its scientific roots.

Before they knew what they were dealing with officials attempted to place Lyme in a box and modelled the disease. They have been studying the same model ever since even though science has progressed in helping us understand this complex disease. Infectious disease doctors ignore reams of peer reviewed published science that demonstrate their conceptualization of the disease is wrong and favour medical dogma instead that states Lyme disease is difficult to acquire, easy to diagnose, readily cured with a short course of antibiotics. If a patient has symptoms following treatment either initial diagnosis was wrong or they have Post Treatment Lyme Disease Syndrome [PTLDS] since there is no such thing as chronic Lyme disease. [Redacted]. I can assure that there is such a thing as chronic Lyme disease and there should be medical code for persistent borreliosis. We now have 3 new treatment options that are published and are improving the lives of patients with chronic/ persistent tick-borne disease. that [redacted] and others would disrespect these patients and throw them out on the street or advise psychiatric counselling for somatic disorder. MyLymeData shows that patients can and do benefit from treatment and now we are moving into the era of personalized precision medicine before the powers that be in the CDC are willing to admit there is a serious problem.

We don’t even agree on what we are talking about. IDSA/ AMMI[Canada] definition: “Lyme borreliosis is caused by the spirochete Borrelia burgdorferi [strain B- 31] and is transmitted by deer ticks [Ixodes scapularis]. Our definition: “Lyme disease is a tick-borne zoonosis caused by several genospecies of the spirochete Borrelia burgdorferi sensu lato.”  [In the broad sense]. We now have B. Miyamotoi right across this country for which there is no good test. The CDC/ IDSA made the mistake of defining the disease by the test and not the symptoms. Better test exist but aren’t used less they produce results different than those expected. The much over-emphasized rash is the disease to infectious disease doctors. The rash is the early acute symptom and is experienced by less than half the patients yet it is the end point for these doctors. When the rash disappears the patient is better and any lingering symptoms are due to something else.     Continues: See attachment

Sincerely,

Dr. Rob Murray [DDS ret’d]	Lunenburg, NS	Canada	Board member Canadian Lyme Disease Foundation

----

## Richard Knowles

In our part of the country, I can ask (and have) any random person if they have had a tick borne illness or directly know someone who has and every time they say, yes! I also know someone whose friend died from it.

But more commonly it's disrupted their lives for one to two years with aggressive symptoms. And for the rest of their lives with periodic recurring problems.

I've have it. [Redacted] has it. [Redacted] has it. [Redacted] would have died from it, saved only by a CDC doctor that worked relentlessly for many days until he figured out the vector.

[Redacted] had it so bad that at one point she was gulping for air around-the-clock because the sensation was that of drowning. Can you imagine what it felt like to see this as a helpless [redacted]? To this day she continues to need medication. And fights with the insurance company every year for access to the medication that is effective. The saddest aspect of [redacted] situation is that she was misdiagnosed because doctors are reluctant, uninformed, or aren't knowledgeable about the use of multiple Lyme tests. She missed the window of the rapid high intensity treatment and that led to the chronic condition she suffers with.

A friend of mine has recurring periodic pain that takes out use of one of his knees leaving him unable to walk for days at a time. He has not been offered any treatment path for his chronic Lyme condition. It took several visits for him to even get the appropriate test that resulted in the initial correct diagnosis.

Lyme disease hit my [redact] so hard that he had to retire. He simply couldn't kneel down to do his job.

Lyme borne diseases are a continuous pandemic that effects hundreds of thousands of people every year.

I was told by my doctor at a well known hospital that I should seek help elsewhere because the hospital didn't support Lyme diagnosis.

The evidence for the chronic nature of Lyme is before the medical community and yet it's ignored. An official label for the chronic condition would go a long way to patients getting appropriate treatment.

More doctors should read PubMed. It's awesome.

Best Regards,

Richard Knowles

----

## Infectious Diseases Society of America

The Infectious Diseases Society of America (IDSA) appreciates the opportunity to submit comments to the Tick-Borne Disease Working Group. IDSA is the largest infectious diseases medical society in the United States, representing more than 12,000 physicians, scientists, public health practitioners and other health care providers specializing in infectious diseases. Our members care for patients of all ages with serious infections, including tick-borne diseases. IDSA is committed to ensuring that patients receive the highest quality care for infectious diseases, including Lyme disease. Society members focus on the epidemiology, diagnosis, investigation, prevention, and treatment of infectious diseases in the U.S. and abroad.  

We have great sympathy for patients and their loved ones who suffer from both short- and long-term effects of Lyme disease or other conditions. Our goal is for all patients to achieve the best possible outcomes.  

IDSA comments below reflect our understanding of the Working Group's draft report contents based upon the discussion at the Oct. 27 meeting; however, we are concerned that meeting materials are not made available to the public ahead of the deadline for comments.

IDSA is pleased that some of the draft report chapters offer important recommendations to strengthen the federal response to tick-borne diseases. We welcome the opportunity for ongoing dialogue with the Working Group to ensure that its recommendations are grounded in the best available scientific evidence and best serve patients' interests and public health. These comments concentrate on chapter 8 and chapter 1, as they were the primary focus of the most recent Working Group meeting. For our feedback on all of the chapters, please see our most recent comment letter.

**Chapter 8: Epidemiology and Surveillance**

We support the inclusion of accurate and relevant citations to support statements made in the draft report; however, we also note that context is essential. For example, in the case of a paper written before antibiotics were known to treat Lyme disease, this reference is useful to support the case fatality rate of untreated patients. We also support the inclusion of clarifying language to note the current limitations of surveillance concerning the geographic distribution of ticks that carry *Borrelia burgdorferi*.

**Chapter 1: Background**

IDSA supports the inclusion of a link to the Centers for Disease Control and Prevention (CDC) national tick surveillance program.

We are concerned about the inclusion of "real-world evidence". This phrase is defined as data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials. It was included in the 21st Century Cures Act as a way to allow such “non-traditional” data to supplement that from randomized clinical trials and support regulatory decision-making. We are concerned that the request to use this phrase in the report would be beyond the scope of its definition and inappropriately allow for the inclusion of anecdotal evidence that is not rooted in the best available science.

**Conclusion**

IDSA thanks the Working Group for its attention to tick-borne diseases and looks forward to the opportunity to help inform and advance evidence-based policy that will best serve patients and public health overall. 

----

## Wendy Phillips 

To the Tick-Borne Disease Working Group,

I am the Founder and Executive Director at The Lyme Treatment Foundation, and I have Lyme disease.

Before being diagnosed with Lyme disease, back in 2017, I was in graduate school in California studying biochemistry. I ended up leaving my graduate program because of a mysterious illness that no doctor could diagnose.

I moved back home to Florida and the symptoms I was experiencing were becoming unbearable.

By January 2017, I was suffering with seizure-like activity, neuropathy, heart problems, excruciating back pain, dizziness and more.

It wasn’t until I was 26 and was experiencing heart palpitations of 190 beats per minute, that I was admitted into the hospital for my heart in July 2017. I truly thought I was going to die from this horrendous disease.

Luckily, while I was admitted into the hospital, an amazing nurse named Jamie came in and said that she thought that I had Lyme disease. The multiple physicians who saw me that day in the hospital disagreed, but this incredible nurse sent me to my current Lyme doctor, and I have been in treatment since 2017.

I still have symptoms.

This disease is a systemic, long term, horrific illness and even worse than the symptoms, is the way physicians treat these patients, who are just looking for answers, just looking to reclaim their lives and health.

Most physicians do not understand this illness, they do not understand that it is a chronic, debilitating illness and patients are often laughed at, told to see psychiatrists, etc. and end up suffering indefinitely.

I run a non-profit where we solely provide funds for treatment grants to help those suffering from chronic Lyme disease. We provide up to $4,000 treatment grants that are paid directly to Lyme literate physicians on behalf of our grant recipients.

In our first year, we received over 450 applications from people all over the country pleading for funds to treat them long term.

This year, we even expanded our granting program to those living in Canada, too, thanks to our new partnership with The Avril Lavigne Foundation.

Here are some stats about our grant applicants that we calculated in our first two granting rounds from Fall 2019 and Spring 2020.
                          - 76% of our grant applicants report experiencing debilitating heart symptoms
                          - 89% of our grant applicants report experiencing daily pain
                          - 63% of our grant applicants report being unable to work

People are suffering. I read all of the grant applications that we receive, and it is truly horrendous what is going on. This is a chronic illness and should be designated as so. In our own applications, many entire families are affected and cannot afford proper testing and long-term treatment and they need your help.

We need accurate blood tests, so that those suffering from Lyme disease and other tick-borne infections can be diagnosed early. We need this so that people do not develop severe symptoms from a late-stage diagnosis. We desperately need your help.

We also need long-term treatment covered by insurance. Too many people and families cannot afford long-term treatment on their own, as we see daily from those who apply for treatment grants with us at Lyme Treatment Foundation.

And worse, with so many being unable to work, many of our applicants have attempted filing for disability, but because Lyme disease does not qualify as a disabling condition, almost all of them are denied. We need your help getting employers to recognize how debilitating this disease is.

Some of our grant applicants have lost their homes due to attempting to pay for long term care on their own and many of them have multiple family members affected by this illness.

Please, vote on calling this a chronic illness. The suffering happening cannot be put into words and we need your help. Labeling this illness for what it is, a long-term disabling condition would help countless lives.

Thank you for your time and understanding on this matter,

Wendy Phillips	Founder & Executive Director	Lyme Treatment Foundation, Inc.

----

## Anonymous 16

My husband and I, and thousands of others have regained our health due to extended antibiotic treatment.

[Redacted]

Our dog became infected first, then my husband, then me. While our dog was put on a month’s worth of antibiotics, which is more than the CDC recommends for people, my husband and I languished, undiagnosed and untreated for months. Formerly an avid runner, my husband was reduced to playing Candy Crush on the couch in his robe. He wouldn’t admit there was a problem until he fell down the stairs. Meanwhile, I ignored my gynecological symptoms until they metastasized systemically, as he appeared far worse. 

Trying to find answers to our spiraling health, I explained our multiple migrating & relapsing symptoms to my kids’ coach, who said, “This sounds like a page out of my book. I was just diagnosed with Lyme disease.”

This new information sent me on a quest that has never ended.

In my experience, this is how people finally get answers to their perplexing health deterioration: from other experienced patients. Due to the ignorance of mainstream medicine which follows antiquated and biased science which relies heavily on abysmal testing that misses over 70% of cases, and in this case 86%, where patients rarely test positive. If they win the testing lotto by getting a posititive, they are told it’s a false positive. A local woman called me yesterday in this exact scenario testing positive **three** times, but was told it was a false positive and was sent packing. It’s a damned if you do, damned if you don’t situation where patients continue to lose.

The ugly history behind testing is something from a science fiction novel, only it's very real. There's been a long-standing concerted effort at suppressing direct diagnostic tests, and questions go unheeded.  There's currently a $58.1 million lawsuit against the CDC for using its regulatory power to block application of a highly reliable direct DNA test and for channeling public funds to promote their own patented tests.

We are forced to seek help where we can find it due to this unscientific dogma which borders on the absurd.

Even though the history of tick-borne illness dates back to the 1800’s, working knowledge remains infantile, and having just read Polly Murray’s work, The Widening Circle,very little has changed in over 40 years. The issue of persistent infection continues on unabated, yet continues to be experienced by patients worldwide.

Due to our lives and health dissolving in front of our very eyes, we in Lyme-landlearn quickly if we want to get our health back we need to go outside mainstream medicine which continues in this endless juggernaut due to the severe conflicts of interest of our public ‘authorities’, whom have rigged the diagnostic test for their own patent purposes and continue to control a narrative keeping people from proper diagnosis and treatment - which includes what is being taught in medical schools. 

These are simple verifiable facts. 

We also suffer due to mainstream medicine’s simplistic germ theory that doesn’t match our symptom picture at all; mainly that we are typically infected with far morethan just borrelia, the causative agent of Lyme disease.  Garg et al. not only show the polymicrobial (multiple pathogens)nature of the disease(s) but the fact borrelia is pleomorphic (shape-shifts); facts the chronic Lyme denierscontinue to ignore.

These two issues are at the crux of understanding of Lyme/MSIDS - or multi systemic infectious disease syndrome.

Further, mythology abounds: 
                          - We are are told nearly 80% get the "classic" bullseye rash, when it is highly variableand not "classic" at all.  This is problematic not only from a diagnostic stand point but because having the EM rash is often entrance criteria into research studies. By utilizing this criteria, as well as only positive 2-tiered testing, studies are omitting a huge subset of patients - probably the sickest ones.
                          - We are told that only 10-20% go onto develop symptoms after treatment, when it's more like40-60%when you count those that were diagnosed and treated late (nearly everyone I deal with).
                          - We are continually told things are "rare," only to have information quietlyupdated later.  We are continuallytold Lyme/MSIDS can't be in certain locationsonly to be told later it existsafterdenying thousands treatment.
                          - Southern patients have been fighting for decades to be properly diagnosed and treated but have been ruled by Andrew Speilman'sIron curtain.
                          - Researchers continue to use the popular "climate change" moniker in their work, eating up precious research dollars, when independent research has proven tick proliferation to be caused by migrating birds and photo-period.  Ticks laugh at the weather.Rather than answering the very real question of the bioweaponization of ticks being dropped from airplanes,public 'authorities' continue a slight of hand by pushing the climate agenda.
                          - We continue to be told Lyme/MSIDS can't be spread sexuallywhen researchand experience indicates it can be. We were told it didn't occur congenitally, yet much research and experienceshows otherwise.

Wisconsin has a long history of tick-borne illness with many experienced doctors. [Redacted] Wisconsin physician,disagreed with his colleagues and successfully used high dose IV antibioticsfor those with chronic Lyme disease.  

“I have to come to the conclusion that there is an epidemic of chronic Lyme disease occurring in the United States that warrants more attention than it is getting from the government and the academic medical establishment. It is hard for me to believe that 51 cases of what I call the chronic Lyme disease syndrome represent a figment of my imagination....I suggest that those who doubt that the Lyme disease syndrome exists and that it can be treated turn to the over 200 peer-reviewed references included in summary articles written by two giants in the Lyme disease field: Dr. B.A. Fallon and Dr. Steven Phillips.”  Dr. Waisbren  

If Waisbren thought chronic Lyme disease was an epidemic in 2011, what would he think now?

And what about those peer reviewed references showing chronic infection? Why are they continuallyignored?  Here’s over 700.  And some newer ones.

The reason chronic Lyme/MSIDS is the crucial issue to be addressed is because there are thousands upon thousands that continue with severe symptoms after the outdated and unscientific CDC mono-therapy. 

Biased, poorly done research on this issue states that further treatment doesn’t help yet [redacted], myself, and countless others prove that axiom to be completely wrong.

Thankfully, ILADS trained doctors despite being persecuted, listen to patients, defy the accepted narrative, and are willing to treat longer and with numerous antimicrobials to address the often present coinfections. After-all, relapses have occurred in nearly every single antibiotic study ever done. 

Treatment for this complex illness takes a savvy nuanced approach. [Redacted] and I are living proof that a judicious use of antibiotics is not only effective but safe if done correctly. 

Antibiotics are only part of a multi-pronged approach in treating this beast.  I suggest you listen to the thousands of ILADS trained doctors and other professionals rather than vilifying them.

I often shutter when I consider what would have happened had we remained under a doctor adhering the CDC guidelines which mainstream medicine follows as a literal mandate.We very well might be dead as we both had heart involvement.

Research for Lyme/MSIDS has only progressed when it is independently done. 

Lastly, I would like to include some quotes:

“The presence of live spirochetes in a genital lesion strongly suggests that sexual transmission of Lyme disease occurs,” said Middelveen. “We need to do more research to determine the risk of sexual transmission of this syphilis-like organism.”  Marianne Middelveen, PhD

“**I am convinced that Lyme disease is transmittable from person to person**.”  Lida Mattman PhD 

"We never had in the last five years a single MS patient, a single ALS patient, a single parkinson's patient, who did not test positive for Borrelia burgdorferi.  Not a single one.  Dr. Dietrich Klinghardt

“The CDC is responsible for the current Lyme disease crisis where patients cannot obtain a timely diagnosis through accurate early detection.” Lyme patient and advocate Carl Tuttle

The people who test positive are ironically the ones who really aren’t sick other than a bad knee (Lyme arthritis). This is how after the Dearborne conference, where the case definition was fraudulently changed to a very narrow set of criteria that lyme came to be associated with arthritis, namely an arthritic knee, when in reality that is the very least of the symptoms most lyme patients encounter.

I liken the two tiered testing for lyme to giving a blind person a vision test then telling them they can see – it’s madness!"  Malia McClean

The ongoing and prolific conflicts of interest impede our public 'authorities' from making wise public health decisions.  The fact that only ONE patient representative is on the TBDWG succinctly proves my point. 

Prove me wrong.

Anonymous	Madison, Wisconsin

----

## Anonymous 17

To whom it may concern,

I am writing to emphasize how important it is for all physicians, the medical community, health insurance providers and all others affected by Lyme disease and co-infections to have a proper diagnosis and for chronic-Lyme disease to be recognized.

My 22 year old son has had Lyme disease and several co-infections. It was by accident that we discovered he might have Lyme and were able to find treatment for him. It was all out of pocket, costing us thousands of dollars. It took many years of his young life; being sick, missing school, being misdiagnosed... taking all sorts of drugs, suffering side effects, going to emergency rooms,being treated horribly, going to endless appointments...

My son is now out of treatment after 2 years with [redacted] at the [redacted]. I wish there was a place like it in Boston. If there was, and it was covered by insurance I would have everyone in my family tested. So many people I know have symptoms of Lyme but know nothing about it. Their physicians know nothing about it and rarely test for it. They do not know the latest tests available or where to get them. So many people, perhaps myself, go untested, but are suffering in many different ways.

My son had neurological effects from Lyme that were thought to be bipolar, depression, borderline personality disorder, and intense anxiety. At one point we thought he had HPPD (Hallucinogenic persistent perception disorder). Maybe he did have it, but later we found out he had Lyme too. AFter 2 years of treatment he tested negative for all Lyme/coinfections. He still suffers from PTSD and anxiety though, is taking anxiety meds, sees a psychiatrist... but he is finally able to finish college, or is at least trying to. He's had to take a medical withdrawal twice, extending his college years to 5. Needless to say we have lost a lot of money, but what of his lost youth spent being sick?

We have no idea how long he had Lyme, but if any of the many doctors we took him to had any experience or knowledge of it perhaps it could have been caught sooner. We struggled with his symptoms from the age of 4 years. In middle school he once said that he wished he had cancer because then he wouldn't feel so bad about being sick. People respect cancer, they give kids with cancer gifts and wishes and funding. Instead there was no one else who seemed to understand what was wrong; just more deadends that left us feeling hopeless.

I have a close friend who contracted Lyme disease a month before we were to head off to Ireland for a 2 week trip. She found out a few days before we were to leave that she tested positive for it. She was experiencing facial numbness and pain on one side of her face. She was given prednisone at the time and it made it possible for her to take the trip. That was in 2009. Today in 2020 my friend has trigeminal neuralgia that has been getting worse over the last 10 years. It is in the exact same area where she has facial numbness and pain. She is looking at surgery in her future and it is a risky venture but the medication she takes to fend off the severe pain is no longer as effective and some day soon it will no longer work.

I see my husband go through periods of extreme fatigue, body aches all over, memory lapses, brain fog, and I want him to get tested but his doctor knows nothing about Lyme. We are in an endemic area. Why are doctors so ignorant to this disease? Many doctors say chronic Lyme doesn't exist. It sure existed for my son. I think of all the young folks who are having a terrible time with mental illnesses right now and medications are not helping them regain a worthwhile quality of life. They are never tested for Lyme. I've seen how Lyme can affect a young persons brain and it is awful.

Money, testing, studies - we need more and fast! This suffering is going on all around me and I wish there was some way to help get people tested on a yearly basis so there would not be so much needless suffering and misdiagnosis. I have to submit this letter soon and I hope what I've written makes a case for better access to care and recognition of this chronic disease that is ruining people's lives.

Please call me if you'd like to speak to me about this and get any other information from me. I'd be happy to try and help in any way I can. Just don't ask me for money because I'm still in debt from paying out of pocket for all the treatment my son had. Thank god he had it though.

Anonymous

----

## Anonymous 18

Last November my son Jack decided to withdraw from his sophomore year of college. 

This was not how he imagined his college career would go. In his four years of high school, Jack had been a talented state-ranked runner, a literal straight A student with a 98th percentile SAT.

He was a sweet, driven, social and successful young man. But last November, he was struggling to get out of bed, had severe joint pain, migraines, sensitivity to light, numbness in his feet and severe brain fog. He was struggling in his classes and dropped one engineering class after the other.  He called us from college to say he was scared and could not get out of bed.  We agreed what we were doing to try and help him was not working and we brought Jack home. Turns out, we were treating many varied symptoms for years without knowing there was an underlying cause.

What were his symptoms?  The first was acute kidney failure during the [redacted]. After that came what we thought was depression and anxiety.  Then came more physical pain.  Over the next 2 years, we met with over 10 medical professionals looking for answers and relief.  Looking back, the ignorance of the doctors we saw is astounding.  Jack went to therapy, met with psychiatrists, voluntarily went to in-patient psychiatric care twice.  He took antidepressants, went through neuropsychology, reduced his course load.  None of this was making Jack feel any better. If anything, he was getting worse.

So when Jack came home November 2019, he started fresh with a new doctor. This new integrative MD found the root cause to Jack’s problems.  Finally!  An answer!  Jack had Lyme Disease.  It was a relief to know what was causing all of his pain, but Lyme is a terrible disease that is nearly impossible to eradicate when it has festered for so long.  Jack’s new life includes over 30 pills a day.  He takes antibiotics, supplements, IV therapy, abides by a gluten free diet, does epsom salt baths, infrared sauna — all to try to rid him of Lyme toxins and reduce inflammation. In one year, we have spent over $20,000 out of pocket for his treatment.  And still, he struggles.  Currently, Jack's biggest issues are an inability to focus and maintain thoughts, trouble reading, deep bone pain and fatigue.  He has been to the ER multiple times.  He has trouble walking.  He spends days in bed because of his bone and joint pain. 

**If caught early, Lyme can be cured by 2-3 weeks of antibiotics. ** But since Jack had it for years, it has imbedded and attacked his musculoskeletal system, his neurological system and his immune system.  If this had been caught earlier, he would not have physically and mentally suffered for all these years and missed his college experience.  Our deepest hope and prayer is that someday he will go into remission. 

When Jack collapsed at the [redacted], he literally crawled across the finish line.  Jack has been crawling through life ever since — with this disease attacking his brain, organs and joints. I have a professional photograph of him trying to get back up at the cross country meet when he collapsed — and I look at it periodically, even though it makes me terribly sad. I look at it because it is an image of my boy trying his hardest to get back up. We are doing all we can to help him get back on his feet. 
                          - My son is one of many thousands who are very sick. And, they ALL deserve better.
                          - A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease. We are lucky to live in a large metropolitan area with an amazing Lyme specialist. Not all are so fortunate.  Not all can afford to pay out of pocket for the treatment required to feel better.  We are seeking comprehensive insurance coverage.
                          - If a COVID vaccine can be created in under a year, why not a Lyme vaccine?  We want a vaccine.
                          - If there is A COVID test created in one year, why not an accurate Lyme test that can be administered at an annual physical? Why not test everyone, every year?
                          - We ask the TBDWG recognize and recommend a chronic designation of Lyme disease.

Anonymous

----

## Kaitlin Schotz 

I am writing in support of the designation for chronic lyme disease. I am 33 years old and have suffered from chronic pain, stiffness, fatigue and weakness for more than 5 years as a result of lyme disease. My disease went undiagnosed for many months. Although I urged the doctors to consider this diagnosis they repeatedly dismissed me or told me I had "phantom pain" or "psychosomatic pain". For a period of almost six months my pain and weakness became so severe that I could hardly walk. Every other diagnosis was ruled out and yet doctors continued to dismiss me. I finally found a "lyme literate" doctor who helped me climb my way out. I am about 60% of the way back to my normal but still struggle with chronic pain and fatigue and it's been a very slow and arduous process to recover. I hesitate to even bring up when I see doctors because I know they will just think I'm making it up. When I was out of work for several months because I am a healthcare worker and on my feet all day my insurance (provided through the hospital which I work for) denied me short term disability.  I'm hopeful for more broader recognition, understanding and treatment of this disorder so that people don't go through what I have done through

Kaitlin Schotz

Columbia, Maryland

----

## Linda H

The allopathic medical establishment in the U.S. is in need of greater education on the extent of symptoms and chronic suffering experienced by Tick-borne illness patients. My own case of Borrelia b. infection went undiagnosed for more than seven years. The fourth doctor I consulted had me tested by Western Blot, which I paid for out of pocket. This followed a series of unnecessary blood tests ordered over the seven years for various allergies, heavy metals, intestinal parasites, as well as CT scans, endoscopy, nuclear tag cell scan, and bone marrow sampling. A waste of time, money and suffering! I eat a very restricted diet, take multiple supplements, work only 18 hours per week. My daily nap is two hours long, even though I get 8 hours of sleep each night.

Lyme (tick-borne disease) sufferers need:

1-  An informed medical establishment (including the CDC)

2-  An informed public, who will stop telling us it's in our heads when we complain that loud music makes us nauseated, or our legs hurt too much to climb a ladder and re-stock the shelves

3-  Insurance providers to cover the tests without question, so we can do it at the first sign of symptoms, even if those symptoms never included a bullseye rash

12-year Chronic Lyme Sufferer,

Linda H

Seattle, Washington

----

## Paul B. Ross 

To the Tick-Borne Disease Working Group,

I understand that the TBDWG is scheduled to vote on a chronic designation for the 2020 report to the HHS Secretary and Congress at the upcoming meeting on November 17.

As a sufferer of Lyme and several co-infections for the past 16 years, and who remains disabled as a result, I implore the working group to designate Lyme and its co-infections as a chronic illness.  People like myself have been genuinely ill for years from these infections.  We deserve better than being stigmatized by physician ignorance and public shaming.  It is imperative that those who have been battling such illness be provided with insurance coverage.  Too many people sick from these infections have been denied such coverage based on a falsehood that Lyme and co-infections is an acute illness that can be properly eradicated with a short course of antibiotics.  Such thinking has been demonstrated repeatedly to be patently false.

In addition, a chronic Lyme designation should move the federal government and its agencies like the NIH and CDC to allocate more money for research so that sooner rather than later patients can benefit from a yet to be developed accurate diagnostic test and specifically tailored treatment. 

It is an atrocity that millions of Americans are suffering needlessly because a faction of doctors, mostly in the research community, are clinging to the falsehood that this is not a chronic, intractable and growing public health problem.  Accordingly, please designate Lyme as a chronic illness at your next meeting on November 17.

Respectfully,

Paul B. Ross

Merrick, NY

----

## Shelly Brown 

People are sick. And, they deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified.

A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease.

We are seeking access to accurate testing, insurance coverage for this disease, employers recognizing that this is real.

We ask the TBDWG recognize and recommend a chronic designation of Lyme disease.

----

## David R Thomas 

To The TBDWG,

This is a Written Public Comment.

My name is David R Thomas. At Through [REDACTED]. I am a writer, Publisher, a very active advocate/consultant for the Tick-Borne diseases community. I am not a Doctor, however, I am a very knowledgeable artificial reproductive Inseminator in the animal kingdom. This activity in my life before Lyme has given me a better understanding of the disease, genetics, and bacteria movement through populated areas,

I consider myself a well-educated advocate to the Lyme diseases issues of the day. I am writing to express the need for labeling for Late-stage Lyme, or a popular label, **Chronic Lyme,** for Late stage Lyme diseases issues. I am waiting for this term **Chronic Lyme**, to be addressed and accepted, as it is said to be on the November 17, 2020.

We in the Lyme world that suffer late-stage issues, such as myself, are suffering the worst of this devastation as we are shunned by the best hospitals, quieted by the supposed Best Infectious diseases specialist at these hospitals, as our Doctors are restricted by fear of retribution by the non-believers that we call profit takers of the Tick-borne diseases pandemic. Yes Pandemic is the word now along with the Big C19.   There is a desperate need to give this late stage Lyme and Company a label to, at the very least, give insurance companies the go ahead to cover the trauma and get these people back to a productive state in their lives.

We have the medical personal to help educate, now we need the Label, **Chronic Lyme**, education that is here at the field level to be accepted. This is not likely to happen without a **label**

This term need not be a representation of solely Lyme, but a broader term such as **Chronic Lyme** to cover this area of Lyme that the medical communities refuse to address.

Please give the Lyme community a term of **Chronic Lyme.**

Thank you for Listening,

David R Thomas

Pennsylvania

----

## Anne Snyder 

Hello,

I am a wife, mother, educator, Board Certified Behavior Analyst, and long time sufferer of Lyme disease. I also suffer from two other tick-borne diseases; Bartonella, and Babesia.

I was infected in 2009 and my heath has gradually declined since that time. I spent years bouncing from specialist to specialist receiving the wrong diagnosis or no diagnosis. Two years ago, I finally received the proper diagnosis and began treatment. The treatment helps, but it is costly and very tough on my body. [Redacted] have tested positive for older and newer Lyme antibodies and suffer similar musculoskeletal, neurological, and psychological symptoms to my own.

A huge chunk of my life has been compromised, possibly forever, because of this disease. I worry for my future and I worry for the future [redacted]. I worry if at some point we can no longer afford the treatment. I worry if the treatment has harmful long-term effects. I worry if the treatment might stop working. My treatment currently consists of a combination of 37 different things to be taken orally or by injection, daily. The protocol is comprised of both prescription medications and herbal supplements. I spent years suffering and begging for help from physicians. No one had answers; not the doctors, nor my loved ones. In fact, I was told to go and see a psychiatrist. This is an incredibly isolating illness. I am fortunate to have found other sufferers and we’ve been able to support one another. I am also fortunate that, for now at least, I can access treatment for myself and [redacted] that is only available if one can pay the out-of-pocket price.

This disease deserves recognition. People need help.

Thank you for your time,	Anne Snyder	Knoxville, MD

----

## Lyme TV 

We ask that the TBDWG recommends a chronic designation for Lyme disease.  While the science that explains the etiology of chronic disease from infection with the Lyme bacteria is unresolved, it has been demonstrated in numerous studies that close to 20% of patients experience persistent symptoms after a standard course of antibiotic treatment.  We believe that the epidemiological trend, which adds up to 80,000 patients per year to the pool of the chronically ill, should be actively addressed by public health institutions.  A chronic designation from the TBDWG would legitimize patient experiences, improve coverage decisions by health insurance plans, reduce the frequency of misinformed clinicians and broaden social acceptance for chronic Lyme sufferers in other important contexts, such as the workplace.

As the scientific understanding of tick-borne diseases advances, we hope that the etiology of persisting symptoms is clarified, whether they are a function of chronic infection, untreated co-infection, autoimmune response, permanent damage, antigenic residue or some combination of these factors that may vary from case to case.  We encourage the TBDWG to continue recommending additional federal funding for Lyme disease research in order to create better testing, develop better treatments and resolve these scientific uncertainties.  With 300,000-400,000 infections per year in recent times and a ~20% incidence of persistent symptoms, Lyme disease research funding is certainly worthy of attention from a public health perspective.

We also believe that a prominent flaw in the current discourse around Lyme disease is its treatment as a unified infection, neglecting the clinical implications of recent scientific studies on the genetic variations of Borrelia species and strains, as well as the potential geographic differences in the prevalence of these genotypes.  The different manifestations of Lyme disease from EM rash to neurological, cardiac and arthritic manifestations are all too often discussed as though all patients are confronted by the same exact pathogen.  This is particularly peculiar given the clinical variation produced by different strains of so many other pathogens, such as HIV, malaria, and tuberculosis just to name a few.

Since 1999 studies have shown that 4 specific genotypes of OspC are responsible for the majority of disseminated infections and that greater virulence has also been associated with RST1 compared to other variants of that region.(1)  By ignoring this complexity among Borrelia strains, the portrayal of Lyme disease as a generally simple infection to diagnose and treat is a disservice to both physicians and patients.  Depending on one's luck in this genetic lottery, an infected tick bite may produce something as mild as a self-limiting skin infection that requires no antibiotics to a flu-like manifestation that can be treated by the recommended short course of doxycycline to a disseminated and severe multi-systemic disease induced by an OspC Type A RST1 Borrelia strain requiring multiple rounds of antibiotics and still leaving patients with persistent symptoms.

The underlying variation in Borrelia applies to many aspects of the understanding of Lyme disease.  For example, a study in Europe found that EM rashes were associated with only particular genotypes across the Borrelia species that cause Lyme disease there.(2)  No comparable study has been conducted in the US but given the variable percentages of EM rash that have been published throughout the years it is perfectly conceivable that only certain strains of the spirochete in the US result in this characteristic rash while others exhibit other symptoms upon initial infection.  It is also quite conceivable that regional variation in strains would lead to differences in incidence of EM rash.  For example, confirmed cases in Maine in 2011 had only a 42% rate of exhibiting an EM rash.(3)  There may be similar differences for Lyme cases in the Midwest or on the West coast that are obscured by the national average of 70-80% presented in the CDC data.  We encourage the TBDWG to acknowledge the link between genetic variation and EM rash presentation and to recommend that the CDC updates their information accordingly, thereby helping reduce misconceptions among clinicians and the general public, which result in a lack of diagnosis or misdiagnosis.

We do not know what other important variations remain undiscovered in the Borrelia genome.  For example, it is possible that some strains of Borrelia might have genes that confer resistance to certain types of antibiotics, as is the case with many other pathogens.  In the absence of a test that could specifically identify whether a patient has a mild or dangerous strain of Borrelia, it seems prudent to explicitly inform doctors about the variability in risk in cases of Lyme disease rather than oversimplifying Lyme disease into a single pathogen with uniform characteristics.  We encourage the TBDWG to re-frame the presentation of the risks from a Borrelia infection so that patients and clinicians are less dismissive of Lyme disease and understand its potential to be a serious debilitating illness in a subset of cases.

(1) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC116539/https://www.ncbi.nlm.nih.gov/pubmed/18781866https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6431794/	(2) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3599126/	(3) https://www.maine.gov/dhhs/mecdc/infectious-disease/epi/vector-borne/lyme/documents/2011-lyme-legislature.pdf

Yan Zelener	Director of Science & Research	LymeTV

----

## Jeanne T 

This email is in regards to the Chronic Lyme disease designation.

It is hard to believe that doctor’s are still ignorant about chronic lyme disease and that insurance still denies coverage if they know it is lyme over a long period. I live this situation!  It is horrible enough to have chronic lyme but also insulting that it is not recognized by most doctors, all insurance and some of those close to us.  It must be designated as “Chronic Lyme Disease” so that we can get the necessary treatment for it and have it paid for by insurance. We wouldn’t put up with this if it were chronic cancer would we?  Do not let people suffer longer that necessary without getting proper testing and proper care. Do not penalize and harm physicians who do recognize it and treat it. And, make sure that insurance will continue to pay for the coverage costs for this disease.  Then maybe our family, friends and teachers will recognize it as well and we will not be further stigmatized after the suffering we already do from this disease.

Please support us and make Chronic Lyme a designation.

----

## Michael Crystal

I have seen firsthand the long-term debilitating effects that Lyme Disease has having watched [redacted] go from a thriving, interdependent, highly-functional, energetic and fully-engaged in life young woman to a being a bed-ridden, totally dependent, barely functioning when will this ever end, and seemingly older (yet not chronologically) woman in a short time.  And although she has made great strides in the last 15+ years, to the point where she can be more independent and functioning, the chronic long-term effects of her disease are still very much in evidence.

Lyme may not be cancer or a coronavirus, yet it is in its own way it's just as life-changing and more must be done to better prevent, diagnose and treat this horrid and insidious disease, and if a chronic designation by the TBDWG will facilitate the achievement of these objectives, then let it be designated tout suite!

Michael Crystal

----

## Robin Generaux 

Why isn't the TBDWG discussing this:

A groundbreaking in vivo clinical study conducted by Dr. Richard Horowitz has found that an eight-week course of the leprosy drug dapsone combined with doxycycline and rifampin is effective in improving symptoms in 98% of patients suffering from chronic Lyme disease/Post Treatment Lyme Disease Syndrome (PTLDS).

Dapsone not only acts as a ‘persister’ drug, but also lowers inflammation, has anti-malarial effects, and can be effective in an autoimmune illness.

These are all clinical manifestations that can be seen in **chronic Lyme disease** with associated co-infections like Babesia (a malarial-like parasite) and Bartonella (an intracellular bacterium).58% stay in remission after one year

After using this novel oral, generic antibiotic protocol, 58 percent of those with a history of PTLDS remained in remission for one year or longer, providing new hope for those suffering from chronic Lyme disease. Until now, no treatment has been available for PTLDS. The study is published today in the peer-reviewed journal Antibiotics.

Lyme borreliosis is a worldwide epidemic, which can result in disabling chronic fatigue, musculoskeletal pain, and neuropsychiatric complaints. Between 300,000 and 500,000 new Lyme disease cases are diagnosed in the U.S. every year, with an estimated 2 million individuals suffering from PTLDS.

Prior National Institute of Health (NIH) trials have shown that symptoms of chronic Lyme disease can be as severe as chronic congestive heart failure, leading to long-term suffering and disability, elevated healthcare costs, and financial insecurity.

Insurance companies have usually denied the persistence of Lyme bacteria after standard antibiotic therapies. This frequently leads to a denial of long-term treatment and lack of access to care for chronically ill patients, who are left without answers as to the etiology of their long-term illness.

Persister forms of Lyme bacteria	During the past decade, new research from Stanford University, Johns Hopkins University, and the University of New Haven have shown the presence of novel biofilm forms and ‘persister’ forms of Borrelia in culture, which potentially explains treatment resistance and relapse.

A recent study published in the Springer journal BMC Research Notes, conducted by University of New Haven researchers and Dr. Richard Horowitz, showed how the bacteria that causes Lyme disease, Borrelia burgdorferi, forms biofilms that protect the organism, and that dapsone combination therapy was one of the most effective treatments against the biofilm form of the bacteria.

This study helps identify dapsone’s novel mechanism, which explains in part its effectiveness in relieving resistant symptoms in chronic Lyme disease. The follow-up clinical study demonstrated that combining antibiotics including a tetracycline with older leprosy drugs, e.g., rifampin and dapsone, led to a 98% improvement and 45% long term remission rate in all patients.

Both studies were funded by the MSIDS Research Foundation (MRF) which supports research for causes, treatments, and possible cures of tick-borne and other vector-borne illnesses, as well as the causes, treatments, and possible cures of other acute and chronic diseases.

“The next step is to perform a randomized, placebo-controlled trial using double dose dapsone combination therapy (DDS CT), done in parallel with studies to find answers for resistant tickborne co-infections,” said Dr. Richard Horowitz. “The goal is to decisively prove that the elusive “cure” for Lyme disease that has evaded researchers and clinicians for decades may now finally be within reach, curing the suffering of millions of patients worldwide.”

Dr. Richard Horowitz	[redact[. His latest book “How Can I Get Better? An Action Plan for Treating Resistant Lyme and Chronic Disease” explains his comprehensive approach to treating resistant chronic illness.

MSIDS Research Foundation (MRF)	MRF was formed for the purposes of researching the causes, treatments, and possible cures of tick-borne and other vector-borne illnesses, as well as the causes, treatments, and possible cures of other acute and chronic diseases. The goal of the MRF is to disseminate research and expand scientific knowledge for the benefit of all who suffer from acute and chronic illnesses.

Related Studies
                          - The Springer study showed that higher doses of dapsone were more effective in culture against the biofilm forms of Borrelia (Horowitz, R.I., Murali, K., Gaur, G. et al. Effect of dapsone alone and in combination with intracellular antibiotics against the biofilm form of B. burgdorferi. BMC Res Notes 13, 455 (2020).
                          - Antibiotics (Efficacy of Double-Dose Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease/Post-Treatment Lyme Disease Syndrome (PTLDS) and Associated Co-infections: A Report of Three Cases and Retrospective Chart Review. Antibiotics, accepted Oct 21, 2020.
                          - Retrospective study on 200 patients who improved on dapsone combination therapy (Horowitz, R.I.; Freeman, P.R. Precision Medicine: retrospective chart review and data analysis of 200 patients on dapsone combination therapy for chronic Lyme disease/post-treatment Lyme disease syndrome: part 1. International Journal of General Medicine 2019:12 101–119. Horowitz, R.I.; Freeman, P.R.
                          - Precision Medicine: The Role of the MSIDS Model in Defining, Diagnosing, and Treating Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome and Other Chronic Illness: Part 2. Healthcare 2018, 6, 129.  https://www.ncbi.nlm.nih.gov/pubmed/30400667 ; Horowitz RI, Freeman PR (2016).
                          - Retrospective study on 100 patients who improved on dapsone combination therapy (The Use of Dapsone as a Novel “Persister” Drug in the Treatment of Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome. J Clin Exp Dermatol Res 7: 345. doi:10.4172/2155-9554.1000345).

Robin Generaux, PhD, CRC

----

## John Veneziale

My name is John Veneziale from Doylestown PA, when I was in my early 20’s I was bit by a tick a got the perfect “classic” Bullseye ring on the back of my calf. I immediately went to my Doctors & took Antibiotics which seem to do great and no symptoms occurred. Fast forward to when I was 45 I got a Concussion and started to get Anxiety & Panic Attacks, my body & Immune system were breaking down. !! I took a course to calm my Anxiety but now I was having these Crazy side effects, my Stomach was killing me, my eye whites were Bloody, my Joints & neck were killing me & I was having bad brain Fog. I went to the Gastrointestinal for my stomach , they could see nothing but said it was very red.?? I went to a Neurologist (Twice) for brain fog - Told I was fine (Twice). **Not fine**.  I then was reading an article in a Bowhunting magazine about a guy who had Lymes Disease Bad and **every single side effect he said – I had**!!! So I heard about Dr. Rawls book and I started Treating my conditions like Lymes Disease and eating better for my stomach and taking herbs like Japanese knot weed, Cats Claw , Andrographis , Slippery Elm, Chlorelle and Probiotics and I Started Feeling Better within weeks . **Unbelievable I owe** Dr. Rawls for Saving my Life.

John Veneziale	Doylestown Pa

----

## Anonymous 19

This is a request to provide a designation of Chronic Lyme Disease to more quickly and effectively treat patients for Lyme Disease.
                          - Many of us are sick. We deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified.
                          - A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease.
                          - We are seeking insurance coverage for this disease and employers recognizing that this is real.

I was bitten by a tick on May 27, 2017, with a rash and lump visible at the site. Treatment consisted of two weeks of Doxycycline.  The rash and lump eventually disappeared but other symptoms soon appeared and in time became more severe.

After nearly a year after the bite, I was able to get an appointment with a physician who had over three decades of experience with tick borne diseases and had worked with Dr. Burgdorfer. His finding was that I had the symptoms of and blood tests confirming Borrelia and was treated with antibiotics.

While significantly reduced, some symptoms were not resolved completely.  Additional treatment with other antibiotics has helped.  After two years and seven months additional blood tests confirmed the presence of co-infections of Ricketsii and Bartonellosis. The antibiotic treatments are improving my condition.

There is 0.000000 doubt that my Lyme Disease and co-infections are chronic and initial treatment with Doxycycline is not adequate to cure them and that CDC testing is grossly inaccurate as are their reporting criteria.

Now my wife has Lyme and co-infections in spite of very thorough treatment of our clothes with pyrethrin and skin with tick and insect repellent we found and I removed a tick from near her navel.  There was no rash! Later she became very fatigued sleeping late, most significantly showing signs of memory and focus issues, muscle and joint pain. Our primary required a test for COVID which after some delay was negative.

We then obtained a blood test and submitted it to the lab [redacted]  and the results were forwarded to our physician and those test results **and**symptoms confirmed Borrelia, Babesia, Bartonellosis. Ricketsii and Relapsing Fever.

Since July my wife has been treated with Doxycyline and some, but not all symptoms have abated and she is now starting another antibiotic. Most significantly, she still suffers from fatigue with maybe five hours a day of nearly normal function.

We are not the only ones who have suffered from chronic Lyme at a financial loss and physical suffering.

A nurse at our pain clinic admits to over two years of suffering from Lyme.  My cousin's grand daughter finally was "cured".  She is a junior at Vassar and contracted Lyme at the age of 18 months.

It is difficult to grasp why Chronic Lyme Disease is not recognized and trust it will soon be.  Since Borrelia is primary it is not the only disease found in ticks, coinfections also need mention as accomplices.

Anonymous	Kansas City, MO

----

## Anonymous 20

I’m a father of a now 20 year old daughter suffering from the effects of a persistent Borrelia infection.  It was the Pediatric Infectious Disease Specialist who stated “I know Lyme and your daughter doesn’t have Lyme Disease” which started my wife and I researching and discovering the controversy with Lyme and Tick Borne diseases.  This was when my daughter was 10 years old (already 6 months into this ordeal). 

Like many she failed the ELISA and when a Western Blot was run she only had 2 positive bands.  While she has cultured the borrelia spirochete and had positive DNA’s tests for borrelia she has never had more than 3 positive Western Blot bands at the same time (25 Western Blot tests).  

She has also tested positive for Babesia duncani, Bartonella Henselae as well as a Mycoplasma pneumoniae infection.  All from one tick bite, not from any reinfection.  I know this as this devasting illness has kept my daughter basically in the home and we don’t have pets to “break” the quarantine to bring any ticks into the home.

Not only did the Pediatric IDSA MD miss the borrelia diagnosis but he was also oblivious to the severe Babesia duncani symptoms.  

Unfortunately even 11 years into this and 10 after a proper diagnosis my daughter is still not cured of the underlying infection(s).  

Anonymous

----

## Anonymous 21

I am the mother of a beautiful 32 year old daughter who is suffering every day with Lyme Disease.  It is believed that she has had Lyme since she was a toddler due to her symptoms throughout her life.  She tested positive for Lyme in December of 2016.  At that time , I thought , ok now we know why she is sick so just go to the doctor and get treated and she will be all better.  Little did I know the nightmare ahead of us!!!!!  I am a single women and work as a bus driver so my income is below middle class income and especially more difficult living in expensive New York.  Why do I mention my income ; because Lyme disease is mostly not covered by insurance to treat.  So that means we have had to pay out of pocket for treatment (in our case huge credit card debt).  Which includes: doctors who are trained and understand chronic Lyme (which there are few of) and don’t take insurance for fear of loosing their license, costly supplements, pain medications that are not covered by insurance (compounded medications), lost time at work.  The mental and physical toll is beyond words.  My daughter suffers from pain so painful in all her extremities she passes out .  Her pain is 24/7 for five years now.  Strong pain meds barely relieve her pain.  She had to leave her job, she cannot drive, she has no social life.  She spends her days laying in a couch watching tv to try and distract her from the pain.  As her mother , I am heartbroken!!!  I spend every moment I can researching how to get her well.  I bathe her, brush her teeth, prepare her meals, do her laundry, make doctors appointments, prepare meals, get her heating pads, prepare her medications and try to life her spirits.  I have had to recently take family leave from my job because she now has a PICC line and I give her daily infusions.  I will probably loose my job of 23 years.  Which means I will have no health insurance and no income.  Yes, New York State has a Freedom Care program but who do you know that can live off of $23,00O a year.  My first eye opener to this nightmare is when I joined several Lyme Disease Online groups.  I was saddened and shocked to read the hundreds of stories of persons sick persons and aimlessly searching for help but not knowing where to go, how to treat, where to get accurate testing.  The lack of empathy and lack of knowledge of this disease from doctors my daughter has been seen by is a crime.  This beautiful , kind caring young women has been mistreated over and over my our medical system.  I am the daughter of an RN and a physician.  My father passed many years ago but he would be appalled at the treatment his granddaughter has received and not received.  This disease is real.  Many people are suffering.  This is supposed to be the greatest country in the world.  It isn’t.  My daughter does not deserve to be treated this way.  Most people who die from Lyme disease is through suicide.  Why, because our country doesn’t acknowledge this disease, because people are not getting proper treatment, because doctors are not trained to treat this disease, because doctors and nurses are not empathetic  and are callous to those suffering, because we are financially devastated trying to find help for our loved ones **because they are given no hope**!!!  I have watched my beautiful outgoing, funny, kind daughter suffer and loose hope.  I have saved her from that dark hole many times.  She has begged me for help she has begged me to just kill her.  Can you imagine your child asking you to kill them because she cannot suffer in her pain another moment.  Just imagine.  I am so heartbroken.  She does not deserve this.  No one does.  This turning a blind eye to this disease needs to end **today**.  I am begging you to help us.  Better testing, proper treatment, informed doctors, insurance coverage , research **needs** to be offered **now**.  Please don’t let another moment go by and let her and so many others continue to suffer.  Thank you. 

Anonymous	New York

----

## Anonymous 22

Honorable members of the group, I thank you for the opportunity of commenting on lyme disease. Having been a patient myself with chronic lyme disease and having a daughter who has suffered from chronic lyme disease, I developed a special interest in this condition. Fortunately being a physician I have the ability to investigate the peer reviewed data. I was astounded to see how many articles have documented the strong evidence of persistence of chornic lyme disease (borrelia) and yet most physicians including myself were unaware of it.  In particular the following article listed below made me a complete believer. I request that all physicians on the TBDWG read the full article and I further request that this forum recommends to designate this condition as 'Chronic Lyme Disease'.

Antibiotics (Basel)	2019 Oct 11;8(4):183.	doi: 10.3390/antibiotics8040183.**The Long-Term Persistence of *Borrelia burgdorferi* Antigens and DNA in the Tissues of a Patient with Lyme Disease**	Eva Sapi 1, Rumanah S Kasliwala 2, Hebo Ismail 3, Jason P Torres 4, Michael Oldakowski 5, Sarah Markland 6, Gauri Gaur 7, Anthony Melillo 8, Klaus Eisendle 9, Kenneth B Liegner 10 11 12, Jenny Libien 13, James E Goldman 14

Affiliations  expand	PMID: 31614557	PMCID: PMC6963883	DOI: 10.3390/antibiotics8040183**Free PMC article**

**Abstract**	Whether *Borrelia burgdorferi,* the causative agent of Lyme disease, can persist for long periods in the human body has been a controversial question. The objective of this study was to see if we could find *B. burgdorferi* in a Lyme disease patient after a long clinical course and after long-term antibiotic treatment. Therefore, we investigated the potential presence of *B. burgdorferi* antigens and DNA in human autopsy tissues from a well-documented serum-, PCR-, and culture-positive Lyme disease patient, a 53-year-old female from northern Westchester County in the lower Hudson Valley Region of New York State, who had received extensive antibiotic treatments during extensive antibiotic treatments over the course of her 16-year-long illness. We also asked what form the organism might take, with special interest in the recently found antibiotic-resistant aggregate form, biofilm. We also examined the host tissues for the presence of inflammatory markers such as CD3+ T lymphocytes. Autopsy tissue sections of the brain, heart, kidney, and liver were analyzed by histological and immunohistochemical methods (IHC), confocal microscopy, fluorescent in situ hybridization (FISH), polymerase chain reaction (PCR), and whole-genome sequencing (WGS)/metagenomics. We found significant pathological changes, including borrelial spirochetal clusters, in all of the organs using IHC combined with confocal microscopy. The aggregates contained a well-established biofilm marker, alginate, on their surfaces, suggesting they are true biofilm. We found *B. burgdorferi* DNA by FISH, polymerase chain reaction (PCR), and an independent verification by WGS/metagenomics, which resulted in the detection of *B. burgdorferi* sensu stricto specific DNA sequences. IHC analyses showed significant numbers of infiltrating CD3+ T lymphocytes present next to *B. burgdorferi* biofilms. In summary, we provide several lines of evidence that suggest that *B. burgdorferi* can persist in the human body, not only in the spirochetal but also in the antibiotic-resistant biofilm form, even after long-term antibiotic treatment. The presence of infiltrating lymphocytes in the vicinity of *B. burgdorferi* biofilms suggests that the organism in biofilm form might trigger chronic inflammation.**Keywords:**Borrelia burgdorferi; Lyme disease; antibiotic resistance; biofilms; persisters; spirochete.

----

## KJC

At the upcoming meeting on November 17, 2020 whereby TBDWG is scheduled to discuss and vote on a chronic designation for the chronic impact of Lyme disease in the 2020 report to the HHS Secretary and Congress, I strongly urge TBDWG to vote in favor of the chronic designation. 

I am a 47 year old male, husband (to a practicing attorney in Massachusetts), father of 2 children, practicing attorney in Massachusetts, former college athlete (baseball), active member of my church and productive member of society who has been devastated by the health effects of chronic Lyme disease.  On December 21, 2015, I was struck with overwhelming symptoms (dizziness, shortness of breath, and dropping blood pressure to name only a few) which required an emergency room visit.  This was the beginning of a health crisis that would require 45 medical appointments and almost 9 months until a doctor was able to make the diagnosis of Lyme disease.  I am not sure if it is ignorance of Lyme disease or the active disbelief of its existence that made receiving a diagnosis of the disease so difficult, but it was extremely painful for me and for my family (especially my boy,9, and girl, 8) to not know what was the cause of the health crisis.  I was relieved to have the diagnosis and was sure that my crisis would then be over quickly.  This was not to be.  After myriad medications and treatments, I had run out of all options available in the U.S., so I went to Germany for hyperthermia treatment.  The treatment that I received at [redacted] was instrumental in my healing process.  Though I have not returned to my former level of health, I feel this treatment should be an option for all Americans.  I have been scrutinized by doctors, healthcare workers, friends and family for a disease that is not receiving the proper focus. 

In experiencing the current worldwide health crisis of COVID 19, any fair person would agree that we do not know enough about illnesses.  Those with Lyme disease are frustrated with the apathy and a lack awareness of a disease that is so debilitating and devastating.  Sufferers of Lyme disease need more understanding, empathy and kindness and this will only increase with increased awareness.  Please focus on educating people about this serious disease and please kindly give it the designation of “chronic.”  Thank you for listening.

Respectfully submitted,	KJC of Cape Cod, Mass.

----

### Anonymous 23

I write to you to share my despair at what Janice Sutton so smartly coined: Lyme Denial-itis.

My son has chronic Lyme. It took two visits to the Pediatrician for blood tests to be approved – and me being “that Mom” pushing to add Lyme onto a battery of other lab work.  I left the Drs office that day with my tail between my legs, hating the pushy demanding Mom I had become, after being told “your son does **not** have Lyme and this test is pointless”.  Lyme Denial-itis

That same Dr called the next day to tell me my son had Lyme. I asked how many markers were present. “All nine”, she responded. That can’t have been an easy call for her to make -  his was April 2018 – in Fairfield County CT – where we are educated about ticks, daily checks and the challenges of Lyme.
                          - Not all Lyme presents the same way
                          - Why was the potential for Lyme not considered?
                          - Why have this Pediatrician’s office not used my Son’s case as a learning example?

 After the regular 3 week Doxy protocol did not “cure” my son, we were sent, through my Pediatrician, to the infectious disease specialist. With my 15 year old son sitting next to me, this eminent professional told me he would probably benefit from therapy - as his Lyme was cured and no longer a problem. The [redacted] blood work showed memory Lyme and it was not active. I asked her how therapy would help my previously athletic, energized son to jump out of bed and participate in life? She didn’t have an answer for me. Lyme Denial-itis.
                          - How can an infectious disease specialist be so mis-informed?
                          - How can a specialist allow a patient to leave their office feeling so lost and abandoned?
                          - How aren’t the symptoms – not just the basic level blood work – the primary driver in diagnosis?

 I researched our options and ended up under the care of a Dr who I warmly call my “Lyme Quack”. My son’s condition was validated, explained and solutions provided. Testing from [redacted]. I read up on all the controversies regarding the Quack and Labs – but what solutions did I have?

Back to the Pediatrician that fall for the annual wellness check and school form-filling in. “What is your son doing taking all these anti-biotics. Take him off these immediately. The long term harm you are doing to him is unknown and this is not an appropriate protocol.” My son panicked. We went off the meds. The Lyme came back. Stronger, harder, showing up in cognitive ways as well as physical. Lyme Denial-itis.
                          - How can a Pediatrician be so misinformed?
                          - Just because so many respond to the 3 weeks of Doxy, why can’t they dig into understanding the % of kids who don’t?

Back to my Lyme Quack – who said despairingly  “how can they put kids on 6 or 9 months of aggressive anti-biotics for acne, but not for Lyme? How is a skin condition accepted, but a disease that impairs every element of your life not?”. He was talking about the prevalence of Lyme Denial-itis.

My son was struggling at school due to his chronic Lyme. With the upmost respect for the incredible support team around him, they simply didn’t understand. They didn’t understand that his Lyme wasn’t short-lived or like the flu. They didn’t understand Herxheimer reactions. They didn’t understand why he wasn’t better. Or in therapy, to cope with his panic attacks, – we tried, but the treatment put my son into fight / flight which coping mechanisms couldn’t fix. I explained brain inflammation is unique and challenging and that I wished he had a disease where the seriousness was understood, and I wouldn’t be met by confused stares. Lyme Denial-itis.
                          - How can we educate that Lyme is not a 3 week inconvenience?
                          - Chronic Lyme is real, pervasive and hurting our kids. And the denial surrounding the disease is hurting them even more.

 Two years on, my son went for his annual wellness check -  I told him to be prepared for the Lyme Denial-itis. And yes, he was told he was fine and had nothing wrong with him. School continue to ask “when will he be better”.  I’ve started to say “think of this like cancer and  that my son is in treatment.... It may help change the way you think about his condition, prognosis, timing and expectations”

I am tired of Lyme. I am tired of what it has stolen from my son. But I’m even more tired of Lyme Denial-itis.

Please continue to further your efforts in research, but also in the education of the chronic side of this disease.

----

## Anonymous 24

On behalf of my family and many others who have suffered from the long-term challenges of tick borne illnesses (including Lyme, Babesia, Bartonella), please vote in favor of the designation:
                          - Two of my children are seriously ill; they have missed a combined 5+ years of school. And, they deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified. Many other people are sick and suffering as well.
                          - A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease.
                          - We are seeking access to accurate testing, insurance coverage for this disease, employers recognizing that this is real.
                          - We ask the TBDWG recognize and recommend a chronic designation of Lyme disease.

My family has suffered enormously: medical cost, lost education, lost income, emotional suffering, all in addition to the very real and painful physical effects of this disease.

Thank you for your time and serious attention to this issue.

Sincerely,

Anonymous	New York, NY

----

## Jason George

Please designate Lyme Disease as a Chronic Illness.

I am a Lyme Disease sufferer. I can't tell you how long it took to diagnose and receive **real** treatment for Lyme Disease.

It was one of the most frustrating and **expensive** experiences of my life. I am **still** not out of the woods.

Please keep in mind:

People are sick. And, they deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified.

A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease.

We are seeking access to accurate testing, insurance coverage for this disease, employers recognizing that this is real.

We ask the TBDWG recognize and recommend a chronic designation of Lyme disease.	Respectfully submitted,	Jason George	Brooklyn, NY

----

## Cindy

Let me begin by listing for you the hell in the medical field I have experienced over the last six months:

Nine ER visits - where I was told I was fine.  Also told by one doctor to never return to his ER again.

Outside of the ER doctors, I have seen five internal medicine doctors, a neurologist, two cardiologists, a gynecologist, a menopause/obgyn specialist, an infectious disease doctor, a pulmonologist, an otolarngologist, two ENTs, a dentist

Over sixty blood tests have been completed (with only one tick borne illness test until I found a Lyme Literate Doctor five hours away); CT scans of head, neck, pelvis and chest; eight chest xrays; MRIs of the head, chest, and neck; two echocardiograms; over twenty EKGs; Zio heart monitor for ten days; COVID tested three times along with one antibody test; a stress test; a pulmonary function test; a sleep study; and many more.

Medicines prescribed - Prednisone, Azythromycin, Klonopin, Zoloft, Doxycycline (had to beg the doctor), Diflucan, Cymbalta, Estradiol, Zyrtec, Claritin, Nyastatin, Symbicort, Hydroxyzine HCL, Butalb-Acetamine, Nitroglycerin, Nasacort, Metoprolol, and offered many others. Doxy and Nyastatin are the only two offered that I have completed. 

Time out of work - This began May 21, 2020.  I have been to work two days since that time.  Today is November 6, 2020.

Physical Symptoms I have experienced in cycles:

Fluid in ears-imbalance

Swollen neck gland

Low body temp

Dizziness

Shortness of breath

Tight chest to Very heavy chest to Tight chest

Burning sensation in lungs

Lack of appetite

Sore on front edge of armpits

Tingling in head

Head felt extreme pressure

Neon yellow watery diarrhea

Extreme night sweat to mild night sweat

Fatigue

Hot pulses up arm and spine

Thigh muscles weak

Felt as though throat swelled

Possible dehydration

Racing heart

Drooping eye

Jaw tight

Swallowing

Skip in pulse

Weight loss

Swollen gland at times eventually on doxycycline neck, armpit and groin swelled.

Burping

No/little sleep at night due to discomfort and constant wake ups for four months

Histamine allergy 4 days

Hypothyroid symptoms

Hyperthyroid symptoms

CSF leak  head pressure

Vertigo

Headache

Vision loss some days

Hearing loss some days

Carpal Tunnel

Nerve damage

Overall feeling of not well

Blocked breathing while sleeping

Crawling sensations

Slowed heart rate

Mental breakdowns

How many times I have been laughed at, told nothing was wrong, told there was no such thing as Lyme especially in my area, told I needed to see a counselor, told that if I wanted Lyme, they could get someone to say I did, told not to return to an ER?????   And more.......

Prior medical history - I have only been to a doctor when I had mono and strep throat in the past twenty plus years.  I literally didn't go to many routine doctor visits.

After begging for doxycycline, I was given two weeks worth.  When complete, I was not well.  Convinced another doctor to do one more week.  Post this....still not well.  I have had to simply figure out and treat each individual symptom as it cycled through.  Two weeks ago I found a Lyme Literate doctor online who didn't charge $45,000 - $150,000.  I have **now** been given tests that will help determine phases of treatment.  I have **now** been given peace that I am not crazy.  I am beginning to see light at the end of this tunnel.  Current treatment, both holistic and medical, seem to be drastically improving my life. 

This cannot be what happens to people who are seeking help in such a scary time of life.  With many visits I have had to defend my character, intelligence and physical ailment.  I am a woman with five college degrees/certifications.  This has been debilitating.  Up until two weeks ago, I have had to try various treatments/changes in lifestyle from **google** searches to survive!!!  My family has been greatly affected.  This truly should not have to happen to any individual.  Testing and treatment must be taught to the medical community **throughout the U.S.**!!!!!  This **does not** only exist in the Northeast!!!

Everyone should have access to tests, treatment and extended treatment in any state!!!  This should not require taking out a loan for recovery.  What is going on??!!  I wish I had known about what people were suffering with and how they were being treated long before this.  Mankind, this is not acceptable. 

Cindy in Blount County, Alabama

----

## Erica

As background, I provided oral and written testimony to the first HHS working group meeting in 2017. I cannot believe three years later we are still battling over the term “chronic Lyme.”

I writing here today as a “lyme warrior” as I have been battling “chronic” lyme disease for 9 ears. I never saw the classic "bulls eye rash" and never had a positive Western Blot test.  My symptoms started with joint pain and brain fog, which got progressively more debilitating as I went searching from doctor to doctor and found no answers. Finally, I tested positive for Lyme through a clinical diagnosis from my wonderful infectious disease specialist, [REDACTED]. I am doing a lot better but still battle some debilitating issues.

My three children have lyme disease, my son had a bulls eye rash which was misdiagnosed as ringworm. He contracted lyme while living in New York City, btw.

My daughter was diagnosed with Lyme disease when she was in 8th grade and was only given 30 days of antibiotics by her pediatrician (who did not believe in chronic Lyme). She then developed an eating disorder in 9th grade that got progressively worse, as she ended up in a residential facility by 11th grade.She went from hospital to hospital, as each hospital kicked her out, telling me they could not help her or understand why she refused to eat. By her senior year, she attempted suicide. After her suicide attempt, and with the help of [REDACTED] and [REDACTED], and numerous brain scans and testing, we were able to find out that the Lyme disease was still there, as she had encephalitis in her brain. Luckily, with the help of [REDACTED] and [REDACTED], I was able to pull her out of the residential hospital setting (where she was slipping away) and treat her Lyme and mental illness at the same time. She doing much better now and on the road to recovery. The journey has been difficult as we had to find new doctors for her since her pediatrician still does not recognize chronic Lyme, and her treatment faculties cost us $6,000 a day, mostly paid out of pocket.

We all know, regrettably, that data shows that lyme disease is an under- reported illness and at least six times more common that HIV/AIDS. I testified before that there should be an HIV/AIDS style "Manhatten Project" to combat this serious pandemic. What I have observed is a lot of our taxpayer money going towards a working group that has not made any progress for those of us suffering from chronic Lyme.

My comments today address the term “chronic Lyme. Review the evidence for the existence of "chronic lyme disease, ” below and come up with a new name if you must, but most importantly, publicly acknowledge that the scientific evidence proves that lyme disease can in fact persist. Make a public health announcement so that those of us affected do not have to fight this "silent battle" with our team of scientific based doctors and with insurance companies. Once you publicly acknowledge the chronicity of lyme disease, then internists, Rheumatologists all doctors around the world will stop looking at us like we are crazy.  Furthermore, you might save the lives of many people who might indeed have lyme, but be misdiagnosed with ALS , MS, fibromyalga, chronic fatigue, and other diseases.

You might save those patients like my daughter who might not be fortunate enough to have the medical support of [REDACTED] and [REDACTED].

Read the information below.. just some of the data supporting chronic, and the fact that not just Lyme disease but ANY Infection can cause mental illness.

Stop being ignorant, and consider how many lives could be saved and made better by simply recognizing that “chronic Lyme” exists.

People are sick. And, they deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified.

A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease.

We are seeking access to accurate testing, insurance coverage for this disease, employers recognizing that this is real.

We ask the TBDWG recognize and recommend a chronic designation of Lyme disease.

Thank you so much for the opportunity to submit these comments!

[REDACTED]

**Studies that not only do infections cause eating disorders, but also showing Lyme and other infections  causes mental illness (I list many studies but note it specifically includes suicidality, depression, eating disorders) also social anxiety and autism spectrum disorders**

https://www.mdpi.com/2227-9032/7/4/114/htm

https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2731310

https://res.mdpi.com/healthcare/healthcare-06-00104/article_deploy/healthcare-06-00104.pdf?filename=&attachment=1

https://lymediseaseassociation.org/news/suicide-and-lyme-and-associated-diseases-new-study/

http://danielcameronmd.com/doctors-agree-lyme-disease-patients-risk-suicide-recognized-group/

https://lymediseaseassociation.org/news/suicide-and-lyme-and-associated-diseases-new-study/

https://www.ncbi.nlm.nih.gov/m/pubmed/7943444/

https://www.sciencealert.com/a-case-of-schizophrenia-found-to-be-a-bad-case-of-cat-scratch-disease?fbclid=IwAR20M4NpPU99UnynD4oeXi-bNk3hPwnExKrPJMadWVUOnoEfIqTNqkUNtaE

https://globallymealliance.org/youre-not-crazy-you-have-lyme/

http://vtlyme.org/lyme-mental-health/

https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2731310

https://eatingdisordersreview.com/infection-triggered-anorexia-nervosa/

https://www.edcatalogue.com/infections-associated-with-strep-and-viruses-can-cause-sudden-onset-of-illness-resembling-anorexia-in-children/

https://www.eatingdisorderhope.com/information/eating-disorder/the-link-between-eating-disorders-and-autoimmune-disease

https://eatingdisordersreview.com/infection-triggered-anorexia-nervosa/

https://www.psychologytoday.com/us/blog/expressive-trauma-integration/201906/what-parents-should-know-about-infections-and-mental

http://www.lymepa.org/01%20Underdiagnosis%20of%20neuropsychiatric%20Lyme%20disease%20in%20children%20and%20adults.pdf

https://neurosciencenews.com/bartonella-infection-schizophrenia-10915/?fbclid=IwAR3ANg-2sYesReoKNhtX4cBNuQEZFreCycsuGaFq-quvlmzqYyWXuLUsz_Y

https://www.mdpi.com/2227-9032/6/3/104/htm

https://www.lymedisease.org/kinderlehrer-crazy-sick/

Incredible YouTube video by Dr Marks (mental illness or Lyme ?)— all evidence based research but simply presented

https://m.youtube.com/watch?v=E7T9E2HMmGA

Just to show that government is aware of Lyme pandemic, that chronic Lyme exists (just not sure what to call it, see working group report to Congress:

https://www.mdpi.com/2076-0817/8/3/102/htm

https://globallymealliance.org/news/federal-tick-borne-disease-working-group-releases-report-congress/

http://mcevbd.wisc.edu/news/2018/tickborne-disease-working-group-releases-2018-report-to-congress

https://www.hhs.gov/sites/default/files/tbdwg-report-to-congress-2018.pdf

I western blot is unreliable and in  Maryland (and other states) there is a LAW requirement drs who administer western blot to tell patients it is not reliable:

https://natcaplyme.org/news/governor-signs-first-maryland-lyme-disease-bill/

https://www.nature.com/articles/emi201453

https://www.lymedisease.org/study-cdcs-two-tier-lyme-testing-was-inaccurate-in-more-than-70-of-cases/

https://www.bmj.com/content/369/bmj.m1041/rapid-responses

https://undark.org/2020/06/17/lyme-covid-19-testing/

Studies showing that chronic Lyme exists (some are just confused what to call it ..):

https://res.mdpi.com/d_attachment/antibiotics/antibiotics-08-00269/article_deploy/antibiotics-08-00269.pdf

https://www.mdpi.com/2079-6382/8/4/183/htm

https://undark.org/2020/06/17/lyme-covid-19-testing/

Hopkins (researcher named zhang ) and others had also published numerous articles on Lyme and its chronicitu/ persistence after normal course of antibiotics (last one is most recent)

https://www.frontiersin.org/articles/10.3389/fmicb.2016.00062/full

https://onlinelibrary.wiley.com/doi/full/10.1111/1462-2920.13897

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6023324/

https://rawlsmd.com/health-articles/scientific-community-confirms-chronic-lyme-real

https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1003796

https://www.jhsph.edu/news/news-releases/2019/three-antibiotic-cocktail-clears-persister-lyme-bacteria-in-mouse-study.html?fbclid=IwAR1rk6VkXtX2Fv63jOPVmXKmI9dDwTPHZCbCw-gG5E5Rr1eo3jQ1Kp1ksGE

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4477530/

Research listed at end of article: https://www.cdc.gov/lyme/postlds/index.html

I think this one is even more conclusive because it was done in vitro, so no issues of patient compliance, chance of inadequate dosing, etc. In a petri dish there is really nowhere for the borrelia to hide yet enough survived most of the antibiotics to regrow just fine. https://www.ncbi.nlm.nih.gov/m/pubmed/25806811/

https://www.ncbi.nlm.nih.gov/m/pubmed/26014929/

https://www.ncbi.nlm.nih.gov/m/pubmed/31097026/

This is brief summary of where the controversy lies, already in litigation:

https://www.documentary.org/online-feature/microbes-medicine-and-money-under-our-skin-investigates-lyme-disease

https://www.lymedisease.org/idsa-lawsuit-pfeiffer/

https://www.ilads.org/research-literature/videos/

https://www.lymedisease.org/lyme-dr-steven-phillips/

Tic attachment time :

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4278789/

8) lyme is widespread and deadly

https://www.lymedisease.org/elone-wrongful-death-lawsuit-lyme/?fbclid=IwAR3RBxrKc2nFRuBF2P9bw2RGhKyKtG41hu_HFKCkJid80RLsXY_0NhAw3Do

https://m.youtube.com/watch?v=Fy0ViOX7xNk&feature=youtu.be

9) Tic attachment time:

https://www.lymedisease.org/lyme-sci-tick-attachment-time/

10) lyme and covid

https://m.youtube.com/watch?feature=share&v=wpeKTEvdKvE

----

## Phyllis Mervine

**The Ad Hoc Patient and Physician Coalition Comments on the IDSA Proposed Lyme Guidelines**

In September 2019 the Ad Hoc Patient and Physician Coalition submitted comments on the proposed Lyme disease guidelines of the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR). The Ad Hoc Patient and Physician Coalition consists of patients and physicians who are concerned that the new IDSA guidelines will further restrict access to care and harm patients by leaving them undiagnosed and undertreated.

Seventy-five organizations from 8 countries, including LymeDisease.org, the national Lyme Disease Association, Bay Area Lyme Foundation and others, and the International Lyme and Associated Diseases Society joined the Coalition.

These comments were authored by Lorraine Johnson, JD|MBA, CEO LymeDisease.org and Dr. Elizabeth Maloney, who represents the International Lyme and Associated Diseases Society. The comments were filed on August 8, 2019 and revised on September 6, 2019. I present here only the first section of the General Comments and I urge you to visit the link and read the entire paper. The IDSA has a great deal of power and we need to hold them accountable.

The entire comments can be reviewed at https://www.lymedisease.org/wp-content/uploads/2019/09/Ad-Hoc-Patient-Physician-Coalition-Comments-Sept-6.pdf

LymeDisease.org also published a series of blogs on the subject. You can start here. https://www.lymedisease.org/58-orgs-endorse-lyme-comments/

**Lack of Process Integrity and Transparency**

The IDSA posted its newly proposed guidelines on its website on the eve of July 4thand provided 45 days for comments. The guidelines alone are over 100 pages and the supplemental materials are more than 200 pages. Yet those who would like to comment can neither download nor print these materials for review. This poses an extraordinary barrier to review given the length of the materials. Imposing these types of barriers to comments makes it extremely difficult to review the guidelines or comment on them and undermines process integrity. [*Ed. Note: IDSA responded to this complaint by permitting downloading of the draft and extending the deadline for comment*.]

We would also point out that while this comment system seems designed to insure anonymity, the comments of patient organizations and the International Lyme and Associated Diseases Society (ILADS) should be given a considerable amount of weight by the panel because these patients and their treating physicians, who are the ones most affected by the guidelines, were not meaningfully represented on the panel, and will bear the adverse consequences of guidelines that do not adequately provide for the exercise of clinical judgment and patient values. The panel excluded patients who represent the community and the physicians who treat them.

In accordance with the National Academy of Medicine [(NAM), previously the Institute of Medicine (IOM)] requirements, this panel should “consider all external reviewer comments and keep a written record of the rationale for modifying or not modifying a CPG in response to reviewers’ comments.” (IOM 2011)

The panel should review the previous GRADE assessments developed by NICE, ILADS, and Hayes and Mead (CDC) and reconsider the questions it has posed (or omitted), the outcomes it has selected, its evaluation of evidence, and its recommendations. (Hayes 2003, Cameron 2014, NICE 2018).

These proposed IDSA guidelines are inordinately restrictive compared to the IDSA previous guidelines and to those of NICE and ILADS, which also used GRADE, in terms of diagnosis, treatment durations, retreatment options, and persistent manifestations of Lyme disease. In addition, the outcomes evaluated as well as evidence assessment and translation into recommendations are remarkably incongruent with all other Lyme disease GRADE assessments conducted to date. The panel should reconcile its evidence assessment with those of NICE and ILADS.

The guidelines overstate the evidence base and fail to acknowledge that the science in Lyme disease is emerging and evolving. In persistent Lyme disease, there are only four randomized treatment trials. (Klempner 2001, Krupp 2003, Fallon 2008) The few clinical trials in Lyme disease that the NIH has funded utilized very small samples (ranging from 37 to 129) and screened out between 89% and 99% of those who applied, resulting in study samples that were not representative of the overall population of chronic Lyme disease patients. By failing to acknowledge the emergent evidence base, these guidelines give a false appearance of settled science and prematurely close the door on research. This is an ethical violation that misrepresents the state of the research in Lyme and may diminish research funding. It is an unprofessional and irresponsible response to a growing crisis that the CDC estimates has more than 300,000 cases a year. Lyme disease is a research-disadvantaged disease that already has less clinical research conducted than leprosy, which has an incidence of 200 cases a year. (Goswami 2013)

In addition, the guidelines have significant omissions vital to those assessing the quality and transparency of these guidelines. These omissions were raised in previous comments on behalf of patient groups to the guidelines plan, which indicates that their omission here would not simply be an oversight, but rather an intentional attempt to mislead those using the guidelines. Fundamental transparency requires disclosure of the following: (a) the existence of a controversy in the treatment of Lyme disease, (b) the existence of competing guidelines by another medical society, (c) the fact that the IDSA guidelines have been subject to multiple antitrust actions, and (d) that the lack of process integrity and transparency in previous guidelines caused the NAM to publicly admonish the IDSA and recommend that it remedy these problems in its future guidelines.

The guidelines need to acknowledge that there is a divergence of opinion in both the physician and researcher communities regarding the diagnosis and treatment of Lyme disease so that readers are not misled into believing that the IDSA guidelines are unchallenged or that alternative standards of care in the treatment of Lyme disease do not exist. The guidelines also should disclose the existence of conflicting guidelines by a competing medical society, the International Lyme and Associated Diseases Society (ILADS).

Until recently, when its funding was subjected to budget cuts, the quality of guidelines was determined by the National Guidelines Clearinghouse (NGC) of the Agency for Healthcare Research and Quality. While the NGC was operational, it posted the 2014 ILADS guidelines under its updated standards requiring that guidelines comply with the NAM standards for creating trustworthy guidelines, including the rigorous GRADE evidence assessment requirements. (Cameron 2014, IOM 2011, Wormser 2006) During this same period, the IDSA guidelines were delisted from the NGC as being outdated. Disclosing this information is a critical component to transparency. It alerts patients and practitioners that there are alternative treatment options and approaches to consider when making treatment decisions.

The ILADS guidelines are patient-centered and included a patient on the working team who had substantial subject matter expertise and was an officer in a widely trusted 501(c)(3) organization that had represented the patient community for over 25 years. (Cameron 2014) These guidelines provide a careful analysis of the roles of patient preferences and outcomes that patients deem important and have been endorsed by a major Lyme disease organization, LymeDisease.org. Reconciling these guidelines with those reflected in the ILADS guidelines should be a fundamental to transparency in these new guidelines. To provide transparency about treatment options and the fact that another set of GRADE compliant guidelines exist, the following disclosure should be included on page one of the guidelines immediately after the author affiliations at line 27 in a typeface that is in bold, is easily legible, contrasts with the background, and is no less than 12 points in size.

There is considerable controversy regarding the diagnosis and treatment of Lyme disease and persistent manifestations of Lyme disease. Two approaches to diagnosing and treating the disease have emerged: one advanced by the Infectious Diseases Society of America, the American Academy of Neurology, and the American College of Rheumatology and the other advanced by the International Lyme and Associated Diseases Society. Clinicians, patients, medical boards, and insurers should be aware of these divergent approaches when making or evaluating clinical care. Antitrust law is concerned with abuses of power. When organizations use their power in the marketplace to “sit in judgment of their competitors” by enforcing their guidelines against their competitors, antitrust issues arise. (Johnson 2010) This occurs when organizations, like the IDSA, have substantial market power to influence the ability of patients to access care by impeding the ability of physicians to provide care due to fear of legal retribution. The fact that the previous guidelines have been the subject of two antitrust actions should be expressly stated so that the readers have an understanding that these guidelines are controversial, have been and continue to be legally challenged, and arise in the context of a professional turf war between two medical societies.

The first antitrust action was an investigation by the Connecticut Attorney General (AG) who stated that the IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing the individuals developing its guidelines to hold financial interests (in vaccine companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies) and by excluding divergent medical evidence and opinion. (Johnson 2010, State of Connecticut Attorney General 2008) This antitrust action implicated all three organizational sponsors of the current Lyme guidelines development process [the IDSA, the American Academy of Neurology (AAN), and American College of Rheumatology (ACR)]. Key members from all three organizations who sat on the panel of the 2006 IDSA Lyme guidelines as well as two of the organizations, the AAN and IDSA, were subject to the investigation by the AG in connection with the development of the 2006 IDSA Lyme guidelines. The second action is an on-going RICO action that maintains that the IDSA has conspired with insurers to deny patients access to care. (Torrey et al vs IDSA et al).

The AG ultimately required the IDSA to review its own guidelines by a panel of the IDSA’s choosing that did not have clinical conflicts of interests. Although this newly seated panel, which consisted primarily of members of the IDSA, confirmed the guidelines previously adopted by their medical society, it did not address the antitrust concerns raised by the AG. (Johnson 2009) A year later, the NAM took the highly unusual step of publicly admonishing the IDSA in its landmark report, “Clinical Practice Guidelines We Can Trust,” in 2011.

“The 2006 lawsuit by Connecticut’s Attorney General against the Infectious Diseases Society of America’s Lyme Disease Guidelines highlights the need for standardization and transparency in all aspects of systemic data collection and review, committee administration, and guideline development, so that questions about these issues do not detract from the science. Guideline development groups must be aware of the many, varied observers who will consider their development processes, particularly when their recommendations are likely to be controversial.” (IOM 2011)

The fact that the IDSA has failed to do heed the NAM’s warning in the development of these proposed guidelines is unfortunate for all those who rely on guidelines to be unbiased, scientifically valid, and trustworthy. Physicians, patients and the medical community need to understand the highly controversial context in which these guidelines were developed. More specifically, they need to understand that competing ILADS guidelines exist and that the sponsoring members of these guidelines have been subject to antitrust actions. Finally, they need to understand that the science in Lyme disease treatment is emergent and developing. The proposed guidelines should disclose these facts.

It is also critical that readers understand the remarkable differences between the proposed guidelines and the two existing GRADE assessments of ILADS and of NICE. This would require that the panel reconcile its guidelines evidence assessments and recommendations with those of the two other Lyme disease GRADE assessments by ILADS and NICE and explain why its assessment and recommendations differ. Because it has failed to do so, the recommendations fail to comply with Standard 5 of the NAM Standards for Developing Trustworthy Clinical Practice Guidelines which requires a description and explanation of any differences of opinion regarding the recommendation.

Phyllis Mervine

Founder and President, LymeDisease.org

**References**

Cameron DJ, Johnson LB, Maloney EL. Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease. Expert Review Anti-Infective Therapy. 2014 Sep;12(9):1103-35.

Fallon, B.A., et al. A randomized, placebo-controlled trial of repeated iv antibiotic therapy for Lyme encephalopathy. Neurology 2008, 70, 992–1003.

Goswami ND, Pfeiffer CD, Horton JR, Chiswell K, Tasneem A, Tsalik EL. The state of infectious diseases clinical trials: a systematic review of ClinicalTrials.gov. PLoS ONE. 2013;8(10):e77086.

Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011. Available from: http://books.nap.edu/openbook.php?record_id=13058.Institute of Medicine. Clinical Practice Guidelines We Can Trust, Standard 5. Washington, DC: National Academies Press; 2011. Available from http://www.nationalacademies.org/hmd/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspx

Johnson L, Stricker RB. The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines. Philos Ethics Humanit Med. 2010;5:9. Available from: http://www.peh-med.com/content/pdf/1747-5341-5-9.pdf.

Johnson L, Stricker RB. Attorney General forces Infectious Diseases Society of America to redo Lyme guidelines due to flawed development process. J Med Ethics. 2009 May;35(5):283-8.

Klempner, M. et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N. Engl. J. Med. 2001, 345, 85–92.

Krupp, L.B. et al. Study and treatment of post-Lyme disease (Stop-LD): A randomized double masked clinical trial. Neurology 2003, 60, 1923–1930.

NICE guideline [NG95], Lyme disease (Published date: April 2018). https://www.nice.org.uk/guidance/ng95

State of Connecticut Attorney General. Press Release: Attorney General's Investigation Reveals Flawed Lyme Disease Guidelines Process, IDSA Agrees to Reassess Guidelines, Install Independent Arbiter. May 1, 2008; Available from: http://www.ct.gov/AG/cwp/view.asp?a=2795&q=414284

Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, Klempner MS, et al. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006 Nov 1;43(9):1089-134

----

## Andrea Jackson

**Thank you Sam Donta, Pat Smith and Scott Cooper** and subcommittee members working **for** patients!

TBDWG: The 2020 Report to Congress **must** – call for the Designation of Lyme Disease as a very serious, detrimental, and disabling illness & it must call for an investigation into the corruption of Lyme medicine. Ignorance or bureaucratic-“oops” can’t explain away 1⁄2 century of Lyme medicine not evolving.

Since the CDC, NIH, HHS has for decades told the medical community and public that Lyme Disease is not a “big deal,” not disabling, rare, easily and accurately tested for, and easily cured, patients do **not**get tested**,** do **not**diagnosed, and do not get any or adequate treatment for acute Lyme. All of these result in their health deteriorating and their becoming a persistent Lyme patients with multi-system illness and serious health repercussions. They become disabled and unable to get a diagnosis, health insurance payments on claims, private disability payment on claims, and federal disability.  Due to that, they lose everything- their health, relationships, ability to work, finances, homes, etc. while greatly suffering. It has happened to millions while the CDC continues to push that “acute cases are what matters” – when their test for acute Lyme gives 71% false negatives and doctors don’t even know to test for Lyme. 

The medical community and the world must be told that Lyme is not rare, not geographically isolated, not only present with a corresponding “bullseye rash” (found to be present in as few as 9%!), and that testing is **very** inaccurate an unreliable for acute cases and non-existent for longterm or persistent cases. They also must be told that Lyme Disease is now and always should have been designated as a chronic and disabling illness.

The TBDWG **must** convey to Congress:
                          - that there are millions of patients that are greatly suffering and millions more that will soon be greatly suffering due to CDC’s don’t test, bad test agenda.

It MUST be explained to Congress that there are millions suffering from Lyme Disease’s longterm impact because:
                          - The CDC’s 71% false negatives test has been used for  decades  – used along with the CDC saying “don’t test” – “don’t test, but if you do, use our 71% false negatives test”
                          - Patients are treated very badly by the medical community and public
                          - Patients don’t benefit from the research and attention warranted this very serious disease. The money that is allocated for Lyme Disease is only awarded to a few researchers who will continue the Lyme myths of “only a rare easily cured illness.
                          - Patients are able to get health insurance claims payed for, and are able to get federal and private disability because the CDC has said for decades that Lyme Disease is only an acute illness that is easy to cure.
                          - Because  many  people have gone years and decades without a legitimate diagnosis due to CDC’s telling doctors not to test and if they test use the CDC’s 71% false negative test (2020 Bay Area Lyme) – only to be treated horribly by ignorant doctors and public shaming, both caused by the CDC’s decades of Lyme misinformation.

During the 2020 TBDWG meetings, the CDC said that the CDC employee-patented Lyme testing is accurate because it tells them what they expect to hear. Patients call the CDC out on this. The test that your employees benefit from the use of gives you the results you expect based on **decades**of your using the test is ignorant.

During the 2020 TBDWG meeting, the CDC, Shapiro, and Walker have removed mention of persistent Lyme from 1st the recommendations and 2nd the text and narrative from the chapters, and patients demand that the recommendations and language be restored and tell Congress and the world that persistent Lyme Disease does in fact exist and results in many very bad outcomes and disability.

The 2019 TBDWG has admitted that persistent Lyme Disease exists and is disabling, yet this year’s committee, primarily through the leadership of Ben Beard of the CDC, Walker, and Shapiro remove 2020 report language that conveys that fact is true and argue that it is not. 

Patients want the TBDWG to stop white-washing their comments or not include them in the summation of comments. For instance – patients are very upset that Shapiro [redact]as he is known for working against patients interest and minimizing patients in a very condescending way. For years he has been testifying in court and in the media that persistent Lyme doesn’t exist and that Lyme disease is no big deal “its not like its HIV” (when that is exactly what it is like when Lyme has impacted your immune system so greatly that you have immune, autoimmune, and neuroimmune disease due to Lyme Disease).  [redact]

Patients want to speak directly to the TBDWG and have their questions answered.

Patients continue to ask for a federal congressional investigation into the origins of what is now called Lyme Disease and into the manipulation and corruption of Lyme medicine. These are comments that are not included in the summation.  There is a lot of very valid proof that should be analyzed and reviewed by people without a vested interest in the outcome of such an investigation.

Patients are not able to get a diagnosis. The TBDWG ignores comments about the TBDWG including it in the 2020 report and the recommendations in a very obvious way that the CDC’s employee-patented Lyme Disease test was shown by Bay Area Lyme in 2020 to give false negative results to 71%  That is 7.1 of every 10 that actually are tested with CDC telling doctors not to test for decades – that are told they do not have Lyme Disease when they do. When a patient is not diagnosed and treated early, the outcome is very bad and leads to disability and serious health issues. Patients lose everything and live in great physical discomfort and pain because the CDC’s testing agenda and test fails patients most of the time. For the CDC to claim that their testing is ‘good” because it tells them what they claim to expect is ridiculous. For the U.S. health agencies to refuse any other valid testing for decades is criminal.

In the March, 2020 meeting, the CDC representative said that acute Lyme is what matters and that the CDC will not educate doctors about persistent Lyme because it will confuse them shows patients and the world exactly what the agenda of key federal representatives and Shaprio has been and what the product of the 2020 TBDWG will be (given Shaprio plus the federal votes decide every vote of the 2020 TBDWG).

It was said in recent meetings that the TBDWG federal members .must vote according to how their agencies would require them to vote. Therefore, to then say that the products of the 2020 TBDWG are not a product of the federal agencies is a lie. Re3dact]When 8 out of 14 are pursuing agency-interest and agenda, then yes, the products do reflect **only** the agencies desired outcome. The TBDWG has become just another corrupted anti-patient effort.

[redact] Walker has repeatedly pushed to have any mention of persistent Lyme removed from the 2020 report and has ridiculed a dedication for ending the suffering of Lyme patients, calling it some kind of negative religious zealotry.  No chair or co-chair should be tied to industry, much less prefer that tie is named rather than their former patient status.

Patients do NOT want future TBDWG members to be industry representatives. Suggesting such a thing shows the complete lack of understanding patient views. Lyme patients want the TBDWG to report to congress that an investigation into how industry manipulated the Lyme case definition and Lyme testing. To place an industry representative on the TBDWG so that this truth remains hidden is an insult to patients.

Patients want to have a say in who will represent them on the TBDWG in the public positions. 2020 has proven that those deciding who will be on the TBDWG in a voting role does not have patients best interest in mind and instead prefers to continue keeping Lyme medicine from evolving.

**Include in the 2020 report:**

The TBDWG was corrupted in 2020.

Shapiro’s [redact] and showed them they can’t trust the U.S. government as he is known to work against patients interests and push lyme-falsities – and he still does (was not a case of innocently being incorrect).

Patients want the TBDWG to quit rewording and excluding their comments.	Patients want a federal congressional investigation of Lyme – how Lyme medicine has been manipulated and corrupted, how it still is, why nobody in government or medicine has put a stop to this (and with that, if the federal government did experiment with tick vectors and Lyme’s use as a bioweapon and then disseminate Lyme-laden tick products)

Patients want the TBDWG report to say that Lyme testing fails and gives 71% false negatives, which leads to patients become persistent Lyme patients, which no test exists for.  These patients become disabled, have no valid treatments, are unable to get any treatments payed for by insurance, and are unable to get private or federal disability because the federal government will not designate Lyme Disease as a disabling illness.

TBDWG Must report that Lyme must be designated as a serious and disabling illness with serious and disabling longterm impacts.

TBDWG must report that health and disability insurers must be required to pay on Lyme Disease claims.

TBDWG must require the CDC tell doctors that persistent Lyme Disease exists and is very serious and that their testing is employee-patented and fails 71% (with false **negatives**!)

TBDWG must tell congress that valid and accurate testing is greatly needed and funding for its development is a national health crisis need.

TBDWG Must report to Congress that patients view the 2020 TBDWG as a committee overtaken by conflicts of interest and the desire of federal agency coverups of past mistakes. The few representing patient interests were out-voted by a skewed voting panel and unable to produce a valid and accurate report.

Andrea Jackson

Weld County, CO

----

## Hilary Jacobson

**Thank you Sam Donta, Pat Smith, and Scott Cooper.**

TBDWG: The 2020 Report to Congress **must** – call for the Designation of Lyme Disease as a very serious, detrimental, and disabling illness & it must call for an investigation into the corruption of Lyme medicine. Ignorance or bureaucratic-“oops” can’t explain away 1⁄2 century of Lyme medicine not evolving.

Since the CDC, NIH, HHS has for decades told the medical community and public that Lyme Disease is not a “big deal,” not disabling, rare, easily and accurately tested for, and easily cured, patients do **not**get tested**,** are **not**diagnosed, and do not get any or adequate treatment for acute Lyme. This profound negligence results in health deterioration and to many becoming persistent Lyme patients with multi-system illnesses and a lifetime of serious health repercussions. Once disabled, Lyme patients are unable to receive a diagnosis, health insurance payments on claims, private disability payment on claims, and federal disability.  Due to this extreme neglect, it is common and foreseeable that these patients lose everything- their health, relationships, ability to work, finances, homes, etc. while also greatly suffering in terms of pain, profound fatigue, and physical deterioration. This is happening to millions of citizens. Unbelievably, the CDC insists that only “acute cases matter” – when their own test for acute Lyme results in 71% false negatives. Because of a lack of education and information, the vast majority of doctors do not recognize the clinical signs of Lyme and are unable to independently diagnose it.

The medical community and the world must be told that Lyme is not rare, not geographically isolated, does not typically present with a “bullseye rash” (found to be present in as few as 9%!), and that testing is inaccurate and unreliable when it comes to acute cases, and non-existent for longterm or persistent cases. They also must be informed that Lyme Disease, if not properly treated, becomes a chronic and disabling illness.

The TBDWG **must** convey to Congress:
                          - that millions of patients are greatly suffering and millions more that will soon be greatly suffering due to CDC’s bad testing protocols.

It **must** be explained to Congress that there are millions of citizens suffering from Lyme Disease’s longterm impact because:
                          - The CDC’s 71% false negatives test has been used for  decades  – used along with the CDC saying “don’t test” – “don’t test, but if you do, use our 71% false negatives test”
                          - Patients are treated very badly by the medical community and public
                          - Patients don’t benefit from the research and attention warranted this very serious disease. The money that is allocated for Lyme Disease is awarded to a select few researchers who propagate the myths that Lyme is “only a rare easily cured illness.” 
                          - Patients are NOT able to get health insurance claims paid, and are NOT able to get federal and private disability, because the CDC has reinforced, for decades, that Lyme Disease is solely an acute illness that is easy to cure.
                          - Because  many  people have gone years and decades without a legitimate diagnosis due to CDC’s testing protocols, Lyme patients are usually viewed as hypochondriac by ignorant doctors and by their ignorant communities--both the results of decades of Lyme misinformation that has been propagated by the CDC.

During the 2020 TBDWG meetings, the CDC said that the CDC employee-patented Lyme testing is accurate because it tells them what they expect to hear. Patients call the CDC out on this. The test that your employees benefit from the use of gives you the results you expect based on **decades** of your using the test is ignorant.

During the 2020 TBDWG meeting, the CDC, Shapiro, and Walker have removed mention of persistent Lyme from 1st the recommendations and 2nd the text and narrative from the chapters, and patients demand that the recommendations and language be restored and tell Congress and the world that persistent Lyme Disease does in fact exist and results in many very bad outcomes and disability.

The 2019 TBDWG has admitted that persistent Lyme Disease exists and is disabling, yet this year’s committee, primarily through the leadership of Ben Beard of the CDC, Walker, and Shapiro remove 2020 report language that conveys that fact is true and argue that it is not.

Patients want the TBDWG to stop white-washing their comments or not include them in the summation of comments. For instance – patients are very upset that Shapiro [redact] as he is known for working against patients interest and minimizing patients in a very condescending way. For years he has been testifying in court and the media that persistent Lyme doesn’t exist and that Lyme disease is no big deal “it is not like its HIV” (when that is exactly what it is like when Lyme has impacted your immune system so greatly that you have immune, autoimmune, and neuroimmune disease due to Lyme Disease). [redact]

Patients want to speak directly to the TBDWG and have their questions answered.

Patients continue to ask for a federal congressional investigation into the origins of what is now called Lyme Disease and into the manipulation and corruption of Lyme medicine. These are comments that are not included in the summation.  There is a lot of very valid proof that should be analyzed and reviewed by people without a vested interest in the outcome of such an investigation.

Patients are not able to get a diagnosis. The TBDWG ignores comments about the TBDWG including it in the 2020 report and the recommendations in a very obvious way that the CDC’s employee-patented Lyme Disease test was shown by Bay Area Lyme in 2020 to give false negative results to 71%  That is 7.1 of every 10 that actually are tested with CDC telling doctors not to test for decades – that are told they do not have Lyme Disease when they do. When a patient is not diagnosed and treated early, the outcome is very bad and leads to disability and serious health issues. Patients lose everything and live in great physical discomfort and pain because the CDC’s testing agenda and the test fails patients most of the time. For the CDC to claim that their testing is ‘good” because it tells them what they claim to expect is ridiculous. For the U.S. health agencies to refuse any other valid testing for decades is criminal.

In the March 2020 meeting, the CDC representative said that acute Lyme is what matters and that the CDC will not educate doctors about persistent Lyme because it will confuse them shows patients and the world exactly what the agenda of key federal representatives and Shapiro has been and what the product of the 2020 TBDWG will be (given Shaprio plus the federal votes decide every vote of the 2020 TBDWG). 

It was said in recent meetings that the TBDWG federal members .must vote according to how their agencies would require them to vote. Therefore, to then say that the products of the 2020 TBDWG are not a product of the federal agencies is a lie. [redact[ When 8 out of 14 are pursuing agency-interest and agenda, then yes, the products do reflect ONLY the agencies desired outcome. The TBDWG has become just another corrupted anti-patient effort.

Patients want the chairs to be replaced. Walker has repeatedly pushed to have any mention of persistent Lyme removed from the 2020 report and has ridiculed a dedication for ending the suffering of Lyme patients, calling it some kind of negative religious zealotry.  No chair or co-chair should be tied to industry, much less prefer that tie is named rather than their former patient status.

Patients do **not**want future TBDWG members to be industry representatives. Suggesting such a thing shows the complete lack of understanding patient views. Lyme patients want the TBDWG to report to congress that an investigation into how industry manipulated the Lyme case definition and Lyme testing. To place an industry representative on the TBDWG so that this truth remains hidden is an insult to patients.

Patients want to have a say in who will represent them on the TBDWG in the public positions. 2020 has proven that those deciding who will be on the TBDWG in a voting role does not have patients best interest in mind and instead prefers to continue keeping Lyme medicine from evolving.

**Include in the 2020 report:**

The TBDWG was corrupted in 2020.

Shapiro’s [redact] and showed them they can’t trust the U.S. government as he is known to work against patients interests and push lyme-falsities – and he still does (was not a case of innocently being incorrect).

Patients want the TBDWG to quit rewording and excluding their comments.

Patients want a federal congressional investigation of Lyme – how Lyme medicine has been manipulated and corrupted, how it still is, why nobody in government or medicine has put a stop to this (and with that, if the federal government did experiment with tick vectors and Lyme’s use as a bioweapon and then disseminate Lyme-laden tick products)

Patients want the TBDWG report to say that Lyme testing fails and gives 71% false negatives, which leads to patients become persistent Lyme patients, which no test exists for.  These patients become disabled, have no valid treatments, are unable to get any treatments payed for by insurance, and are unable to get private or federal disability because the federal government will not designate Lyme Disease as a disabling illness.

TBDWG Must report that Lyme must be designated as a serious and disabling illness with serious and disabling longterm impacts.

TBDWG must report that health and disability insurers must be required to pay on Lyme Disease claims.

TBDWG must require the CDC tell doctors that persistent Lyme Disease exists and is very serious and that their testing is employee-patented and fails 71% (with false **negatives**!)

TBDWG must tell congress that valid and accurate testing is greatly needed and funding for its development is a national health crisis need.

TBDWG Must report to Congress that patients view the 2020 TBDWG as a committee overtaken by conflicts of interest and the desire of federal agency coverups of past mistakes. The few representing patient interests were out-voted by a skewed voting panel and unable to produce a valid and accurate report.

**It is time to take action** or be recognized as a partner in corruption.

Sincerely,

H. Schar-Jacobson

----

## Dorothy Leland 

The following are two summaries of Working Group meetings that I recently posted on my blog, **Touched by Lyme**.

**(Sept 25) Touched by Lyme: Walker & Shapiro fail to change report’s Chapter 7**

The federal Tick-Borne Disease Working Group held another online meeting Tuesday. Its upcoming Report to Congress continues to inch towards completion. At this stage of the game, the report consists of a series of recommendations that have already been approved by the panel. Still under discussion is proposed language to accompany those recommendations. And, as we’ve all come to know, language concerning Lyme disease can be contentious indeed.

Which brings us to the TBDWG’s Chapter 7. It offers five recommendations having to do with educating doctors and the public, as well as the issue of patient access to care. Each recommendation comes with some explanatory paragraphs. This subcommittee was co-chaired by Pat Smith, the only patient representative on the panel. In my view, this chapter succinctly conveys much of what the Lyme community wants from the Working Group. And from Congress.

**Where the rubber hits the road for Lyme patients**

To offer a flavor of how the conversation went, here’s what went down with Chapter 7’s first recommendation.

**Recommendation 7.1: Recommend Federal government websites and educational materials and seminars for clinicians, the public, and public health departments, which discuss Lyme disease, provide information that the state of the science relating to persistent symptoms associated with Lyme disease, is limited, emerging, and unsettled; and increase public awareness that there are divergent views on diagnosis and treatment. Consider that shared medical decision-making may be appropriate in some circumstances.**

Bear in mind that 7.1 was approved—though not without opposition—during a prior meeting. Nothing at this meeting would change that. These guys were only voting on the language to explain the reasoning behind the recommendation. Here’s the accompanying text:

**Patients with persistent symptoms associated with Lyme disease face significant issues of patient access to care involving both providers and insurers, as well as the need for shared medical decision-making in the face of uncertainty. Unfortunately, patients with persistent symptoms associated with Lyme disease report that they are systematically denied access to the care they need. For example:**
                          - 67% report they have postponed or avoided medical treatment due to discrimination, disrespect, or difficulty in obtaining care, and nearly half report they have been denied treatment (Johnson, Stigma, 2019). 
                          - The majority of over 2,400 survey respondents report traveling more than 50 miles and a substantial minority traveling more than 500 miles for Lyme disease treatment. (Johnson, 2011). 
                          - 50% of the participants in the MyLymeData patient registry report that their clinicians do not accept insurance coverage; 26% report that they cannot find a clinician who treats persistent Lyme disease; and 18% report that they do not use antibiotics because their insurance will not cover them. (Johnson, Chart Book, 2019). 
                          - The majority of persistent Lyme patients seeking care at their local hospital report that they had difficulty obtaining treatment (Johnson, 2011); some hospitals deny hospital privileges to physicians and other practitioners who do not follow the IDSA Lyme disease guidelines. (Stricker and Johnson, 2009; Johnson and Stricker, 2010; Wolfram 2008.) 
                          - 78% of patients with persistent Lyme disease report a delay of six months or more in their diagnosis (Johnson, 2018) and a majority of patients reported seeing seven or more clinicians before being diagnosed (Johnson et all, 2011). 

**Two panelists kick up a fuss**

Can you guess which parts of Chapter 7 [redact] Here are some hints: At every mention of “persistent” symptoms in Lyme disease, Shapiro wrote margin notes such as “untrue and unsubstantiated,” which quickly flashed across our computer screens. He similarly opposed any reference to the ILADS guidelines, though the rest of the group chose to keep the references in. During the panel’s discussion, Shapiro dismissed and denigrated anything taken from MyLymeData, LymeDisease.org’s patient registry. He called it “propaganda.” He said patient registries have no scientific validity.

Pat Smith sharply countered that the National Institutes of Health (NIH) lists 72 patient registries on its website, including ones for such conditions as Alzheimer’s disease and breast cancer. The CDC sponsors a patient registry for ALS. And scientific validity? The National Science Foundation awarded a sizable grant to UCLA researchers working with information from MyLymeData. Four published peer-reviewed studies use data from the registry, as well as seven white papers. (White papers compile information from research, but have not gone through peer review. The CDC and other health and scientific organizations use white papers all the time. It’s an accepted practice.)

Shapiro doesn’t care.

**Treatment options? What options?**

[redact] the concept of “shared medical decision-making.”

Shared decision-making is not a new concept in health care. It basically means that your doctor explains all of your treatment options, and together you discuss them and decide which way to go. Medicare even specifically requires shared decision-making for many treatments. Even so, that process is typically denied to Lyme patients seeking anything beyond the meager and inadequate care offered by the IDSA treatment guidelines.

At first, Walker said shared decision-making was standard medical practice and it was utterly unnecessary to mention it in the report. He wanted to leave it out. When there was pushback to that suggestion, he scornfully responded, “Does that mean I’m supposed to tell my patient to use crystals and homeopathy?”

Despite the fuss kicked up by Shapiro and Walker, however, Chapter 7’s language stayed intact and the caravan moved on. The next meeting is October 27.

**(Oct. 27) Touched by Lyme: Shapiro and Walker tried having it both ways. It didn’t work**

The Tick-Borne Disease Working Group is supposed to bring together 14 people—scientists, doctors, health officials, patient advocates—with different areas of expertise and divergent views about Lyme and other tick-borne conditions. In concept, members would share their own perspectives and knowledge, while paying respectful attention to what others had to offer. Ideally, their final product—the 2020 Report to Congress—would be an amalgam of what they all brought to the table. And it would be more powerful precisely because so many differing voices contributed to it and achieved consensus.

Alas, that ideal falls far short of reality these days. Exhibit A: the Working Group’s October 27 online meeting.

There was lots of strange stuff happening and it was at times hard for those of us in the remote audience to understand it. [redact]

As the panel slogged through the wording of various chapters of its upcoming report, deciding what to keep and what to toss, several curious issues emerged.

**First, what’s a minority response and who gets to file one?**

When a group like this generates an official document, it’s assumed that its members agree with the report’s content. That’s the process of achieving consensus. Over months of discussion, you give a little, you get a little—until the final report is something all panelists can live with. At various points, group members vote on what should be included in their final report. However, if a member strongly disagrees with one or more parts of the finished product, that person can submit an explanation of why. This “minority response” is included along with the main report. (Kind of like a Supreme Court justice writing a dissenting opinion.)

Typically, in order to file a “minority response,” however, the person writing it has to **be** in the minority—at least on that issue. They should also have tried in good faith to reach a consensus on the issues by explaining their perspective to the group and trying to obtain buy in or achieve a compromise on the matter after robust discussion. Failing that, they can then vote “no” on something that most panelists have voted “yes” on–and then submit their minority opinion.

**Working towards consensus**

As patient representative Pat Smith noted in Tuesday’s discussion, “A consensus process means you go in with the idea you are going to work towards a common goal and hopefully get to where everybody agrees.”

But that hasn’t happened with IDSA representative Dr. Eugene Shapiro, who has never had working towards a common goal with the Lyme community on his “to do” list. Shapiro has a history of publicly denigrating Lyme patients and working against their interests [redact]

Furthermore, throughout his tenure on this panel, Shapiro has often skipped meetings entirely, making a point of passing his proxy vote to Co-chair David Walker—who, as a moderator, is supposed to be neutral and not take sides. Thus, there were many group discussions that Shapiro had no part in whatsoever, and yet he was allowed to go on record as voting a certain way because the Co-chair voted for him. (See: Proxy votes violate spirit of TBD Working Group. URL: https://www.lymedisease.org/tbdwg-proxy-votes/

At the Working Group’s September 22 meeting, Shapiro got into a dust-up with Pat Smith regarding the wording of a passage. He then apparently threw up his hands and said something along the lines of, “Well, don’t worry about it. I’ll just put that in my minority report.”

To which Pat replied (I’m paraphrasing): “Be my guest. But remember, you have to vote no on something before you can submit a minority response. Otherwise, you’re not in the minority.”

**A slew of individual responses?**

Behind the scenes wrangling led Pat to seek clarification at the Oct. 27 meeting. She argued that letting everybody submit their own personal reports willy-nilly is a dumb idea. (My phrasing, not hers.) Taken to the extreme, 14 members of the Working Group could all submit a slew of individual responses—making for a pretty unwieldy Report to Congress, don’t you think?

Pat made two motions regarding this matter, including one that spelled out that a panelist did indeed have to vote against the majority in some aspect of a chapter, in order to submit a minority response. She was apparently pretty persuasive, since the motions passed. Even Co-chair Walker voted “yes” on both of them, for himself and Shapiro, who had stepped off the call for the duration of that discussion.

Then, the group broke for lunch. When they returned, Shapiro was back on the line. When he figured out that the group had voted to allow minority opinions only when a “no” vote had occurred, Shapiro sounded irritated. [redact] When he complained about the change, somebody said, “Gene, you voted yes.”

[redact]

Dorothy Leland	Vice-president of LymeDisease.org	Davis, CA

----

## Lucy Barnes

**Over Forty Years Lyme – Less than One Year COVID**

Prevention recommendations failed miserably, undependable tests still on the market, inaccurate reporting widespread, failed treatments and focus on a profit generating vaccine. 

**Lyme or COVID?  Both!**

Within months of the Covid-19 outbreak, and one month after a publication titled, ***Follow-up of adults with non-critical COVID-19 two months after symptoms' onset***, the Infectious Diseases Society of America (IDSA) recognized and officially named the symptoms that remained, returned or developed after acute COVID what they dubbed- Post Acute Covid-19 Syndrome.  (Other names include- Chronic Covid, Long Covid, Post Covid Syndrome, Long Haulers.)  The IDSA already published guidelines for COVID that are updated frequently, yet have not updated their Lyme guidelines for 14 years!

**Some** of the symptoms for both acute and persistent COVID (and Lyme) include:

Flu-like symptoms, fatigue, memory loss, anosmia, psychological distress, difficulty concentrating, cough, fever, weight loss, dyspnea, asthenia, arthralgias and chest pain.

Over 45% of patients (non-ICU COVID group) reported a decline in their health status after experiencing acute COVID-19.  Countless people suffer decades later from chronic Lyme.

**Question** - Why are you fighting to keep **Chronic**Lyme disease and the patients affected by it hidden from view?  They need **Help**!

**References**

***“Follow-up of adults with non-critical COVID-19 two months after symptoms' onset”***

https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(20)30606-6/fulltext#secsectitle0085

**Post-Acute Covid-19 Syndrome**

https://www.idsociety.org/covid-19-real-time-learning-network/disease-manifestations--complications/post-covid-syndrome/

**CDC Covid Guidelines**

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html

**NIH Covid Treatment Guidelines- Panel Members**

https://www.covid19treatmentguidelines.nih.gov/panel-roster/

Lucy Barnes, Director	Maryland Lyme

----

## Lance Tycholaz 

There is solid evidence of **criminal corruption** at the highest levels of Lyme Disease Authority and government.

**Proof:**	This recent report from Canada on chronic lyme disease, which does not stop at the U.S. border, which was **banned** from the public was **exposed**! And, ignored. And, covered-up.

The report is entitled "Chronic Lyme Disease" [redacted].https://canlyme.com/2012/08/14/british-columbia-government-report-on-lyme-disease-schmidt-report/

According to this 2010 Schmidt Report on Chronic Lyme Disease (CLD), and countless others, the only reason CLD is denied by healthcare authorities is because of **criminal corruption** at the highest levels of government - otherwise, this report would have radically changed the landscape **forever**.

A Canadian Government Official, Brian Schmidt, has spelled it out for healthcare authorities and yet, it's very existence is **denied**!

The public is suffering from Chronic Lyme Disease, the government knows about it, but they continue to deny its very existence.

U.S. Healthcare Authorities are well-acquainted with the 2010 CLD Schmidt Report, and all the other CLD publications. They are not complete idiots as so many would presume!

Based on scientific evidence, CLD patients are lied to, abused and violated:
                          - Told, Chronic Lyme Disease does not exist because the CDC & IDSA say so!
                          - Told, Lyme disease is cured with 2-4 weeks oral antibiotics because the CDC & IDSA say so!
                          - Told, it's all in your head
                          - Told, there's nothing wrong with you
                          - Told, get more fresh air and exercise
                          - Told, go back to work and stop complaining
                          - Told, it can't be Lyme disease because the CDC non-diagnostic Lyme tests, for surveillance purposes and not diagnosis, say negative, therefore it must be MS, ALS, CRPS, Chronic Fatigue Syndrome, Fibromyalgia, Lupus, rheumatism... anything they can come up with as long as it is not Chronic Lyme Disease persistent bacterial infection with Borrelia
                          - And, CLD patients are often wrongfully prescribed mind-altering anti-psychotic pharmaceutical drugs rather than treating the underlying bacterial infection

And what about **Morgellons Disease**?

There is 100% proof Morgellons disease is caused by Chronic Lyme Disease, persistent infection with the bacteria responsible for causing Lyme disease, Borrelia.

https://rd.springer.com/article/10.1007/s00403-017-1797-1

And, www.thecehf.og/research

Morgellons is easy to diagnose because of the brightly coloured microscopic fibres visible beneath unbroken skin (caused by Lyme disease. You don't need a CDC Lyme disease non-diagnostic test to prove it. Testing only confirms Lyme bacterial infection).

If these legal claims of CLD, based on evidence of criminal corruption in government, don't convince you because you refuse to accept the 2010 government report on Chronic Lyme Disease, how about reports from a U.S. Senior Human Rights Expert to the United Nations and US Government?

From Amazon Books on $LYME, author Jenna Luché-Thayer:

"$LYME tells how scientific fraud has been orchestrated on a global scale. Every day, greed and collusion are generating millions for $Lyme while disabling and robbing lives of millions."

https://www.amazon.com/Lyme-Medical-Mortally-Corruption-Scientific/dp/172757463X/ref=mp_s_a_1_1?dchild=1&keywords=Jenna+luche-thayer&sr=8-1

Or,

"The Situation of Human Rights Defenders of Lyme and Relapsing Fever Borreliosis: Edition One: The Ad Hoc Committee for Health Equity in ICD11 Borreliosis Codes"

https://www.amazon.ca/Situation-Rights-Defenders-Relapsing-Borreliosis/dp/1722988061

The problem is not a lack of scientific evidence to prove the existence of Chronic Lyme Disease. The problem appears to be limited to **corruption.** Corruption****appears to be demonstrated as out-of-control in 2020, and until now.

And of course, who can forget 1994 Dearborn Michigan Lyme disease conference where the Lyme disease CDC test was neutered, and deliberately made to be more **innacurate**.

Why?

Apparently, according to the evidence, to accommodate a for-profit so-called Lyme disease **vaccine**, which caused much more harm to the public than it ever did any good. But we won't talk about that since the healthcare authorities won't talk about that.

In conclusion, **we the people demand** an **official independent government** "**criminal**" **investigation**, based on the solid verifiable evidence of **criminal corruption**at the highest levels of governing authority as it relates to Lyme disease, and in particular, Chronic Lyme Disease, and don't ever forget, Morgellons disease, AKA Filamentous Borrelia Dermatitis, AKA Skin Fibrosis caused by treatment-resistant Lyme disease bacterial infection.

FYI,

Lance Tycholaz, Texas

PS - I have made no false and misleading statements

----

## Carl Tuttle

Member of NH Governor Chris Sununu’s **HB490 Commission to Study Lyme Disease**: http://www.gencourt.state.nh.us/statstudcomm/details.aspx?id=1515&rbl=1&txtbillnumber=hb490

This comment is directed to Dr. David Walker, Co-Chair of the Tick-Borne Disease Working Group.

During the July 8th meeting you were recorded saying that persistent infection is a religious belief: https://lymediseaseassociation.org/government/federal-government/govt-departments-a-policies/hhs-tbd-working-group/contentious-9-hour-wg-meeting-persistent-infection-a-religious-belief-wg-co-chair-says-yes/

Here’s what the folks at Johns Hopkins and Northeastern are saying:

**1. A Drug Combination Screen Identifies Drugs Active against Amoxicillin-Induced Round Bodies of In Vitro Borrelia burgdorferi Persisters from an FDA Drug Library**

https://pubmed.ncbi.nlm.nih.gov/27242757/

**Excerpt:**

Under experimental stress conditions such as starvation or antibiotic exposure, Borrelia burgdorferi can develop round body forms, which are a type of persister bacteria that appear resistant in vitro to customary first-line antibiotics for Lyme disease.

[redact]

**2. Researchers’ discovery may explain difficulty in treating Lyme disease******

http://www.northeastern.edu/news/2015/06/researchers-discovery-may-explain-difficulty-in-treating-lyme-disease/

**Excerpt:**

“Northeastern Unive­sity researchers have found that the bacterium that causes Lyme dis­ease forms dor­mant persister cells, which are known to evade antibiotics.”

**3. Standard antibiotic treatment for Lyme disease does not kill persistent Borrelia bacteria.******

http://droopyyoupi.blogspot.com/2015/08/standart-antibiotic-treatment-for-lyme.html

**Excerpt:**

- What has tuberculosis and Borrelia burgdorferi in common? In the late stage of the disease occurs persistent (tolerant) bacteria, which essentially means that the bacteria lasts and lasts and lasts. They protect themselves against antibiotics and are difficult to treat.

- Both Borrelia burgdorferi and tuberculosis is relatively easy to cure in the early stages, even with the use of one antibiotic. In the late stage it is impossible to cure the disease with the same type of treatment in the acute phase, said Dr. Ying Zhang when he visited the year NorVect conference.

- Dr. Ying Zhang is a professor at the Department of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health

[redact]

**4. Evidence of in vivo existence of Borrelia biofilm in borrelial lymphocytomas******

http://wtnh.com/2016/02/23/unh-discovers-biofilm-in-those-affected-by-lyme-disease/

**Excerpt:**

“An article by a UNH research team led by Professor Eva Sapi is the first to show that the microorganisms that cause Lyme disease are resistant to treatment due to what’s called a biofilm. A biofilm – which has a protective layer of “slime” – allows the organisms to hide away from antibiotics at the microscopic level.”

[redact]

**5. Ceftriaxone Pulse Dosing Fails to Eradicate Biofilm-like Microcolony B. burgdorferi Persisters Which Are Sterilized by Daptomycin/Doxycycline/Cefuroxime Drug Combination without Pulse Dosing**

**Jie Feng**1**, Shuo Zhang**1**, Wanliang Shi**1**and****Ying Zhang**

http://journal.frontiersin.org/article/10.3389/fmicb.2016.01744/abstract

**Excerpt:**

While the causes for this post-treatment Lyme disease symptoms are unclear, one possibility is due to B. burgdorferi persisters that are not effectively killed by current antibiotics such as doxycycline or amoxicillin used to treat Lyme disease.

[redact]

We have a public health emergency requiring a **Manhattan Project** to find a cure for this antibiotic resistant/tolerant superbug but the thirty-year established dogma or should I say racketeering scheme identified in the Lisa Torrey vs IDSA RICO lawsuit has brainwashed an entire medical community.

Mark Twain once said, “It is easier to fool people than to convince them that they have been fooled.”

Carl Tuttle

Hudson, NH

----

## Anonymous 25

My daughter had Lyme disease at age 5. It took me 4 doctor visits to convince them to test her. I am a veterinarian and diagnose Lyme disease frequently in ONE day in northern New Jersey! We test our pets annually!!! We should be testing humans more often. A simple ELISA test could change the view of physicians. She suffered dramatically due to the time lost in proper testing and treatment. The disease spread through her blood brain barrier and caused lasting neurological effects.

Anonymous

----

## Anonymous 26

Lyme disease has changed my family forever. My beautiful 18 year old son’s life has been changed in ways that  we never saw coming.  Going from a vibrant 12 year old to a man that now has an unpredictable future.  It has also ruined us financially. We are begging for help.

People are sick. And, they deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified.

A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease.

We are seeking access to accurate testing, insurance coverage for this disease, employers recognizing that this is real.

We ask the TBDWG recognize and recommend a chronic designation of Lyme disease.

Thank you -

Anonymous	Frederick, MD

----

## Anonymous 27

My name is [REDACTED]. I am 17 years old. When I was six years old, my life change forever, but I did not know it at the time. I was bitten by a tick while playing outdoors at my grandparents' house on Long Island, New York. Slowly and insidiously, over the next ten years, I would grow very sick until I was bedridden with chronic Lyme disease. Over the years, I have seen western doctors, eastern doctors, doctors of osteopathy, PhDs, reiki masters, holistic dentists, massage therapists, healers and sleep specialists. I have tried over 40 medications for migraines, been administered hundreds of IVs, taking crazy amounts of antibiotics, been zapped by a neuostimulant device, had my sleep tracked by an actigraphy watch, had my alkaline levels balance by different diets and tried to kill the infection through magnet therapy - all in the name of regaining my health. 

Over the years my illness has left me feeling alienated, misunderstood and robbed. My symptoms have persisted for so long that it is hard for people to understand what I go through, even some of my doctors don’t believe me. There are people who think my illness is all in my head. I will be honest, somedays just getting through the day is enough. I have faced many disappointments during my adolescence. I had to drop out of regular high school my freshman year because of my health and I struggle to keep up with classes. Fortunately, I am able to attend a school that offers one-on-one classes so I have more flexibility and I learn more efficiently. I have had to give up activities I love to do on a regular basis like tennis and dance and, I cannot see my friends on a regular basis.  However, I have learned to persevere. I have gotten stronger. I am a more positive person because of my journey. This fall I am applying to college. However, I do not know if I will be well enough to attend, and this makes me nervous and sad.

My battle with chronic Lyme has taught me many invaluable lessons. However, I think there are three that stand out and will prepare me well for the future. First, I have learned that I can only ever compete with myself. Everyday I strive to be a better version of the person I was the day before. It makes no sense for me to compare myself to my peers. Instead, I try to compete only with myself and stay realistic. It is unfair and useless to hold myself to anyone else’s standards. Every day I try to make myself a better, stronger version of who I was yesterday.

Second, I will never underestimate the importance of family, friends and pets in my life. Joy is extraordinary. Sickness has taught me that life is too short for misery. It is important to make the most of every single day.	Finally, I have learned to have the grace to let go of the things that were not meant for me in this life – which can be very hard. This is especially important because the alternative would leave me a very angry and bitter person.

As an advocate for sufferers of chronic tick-borne illnesses, my goal is that the physical and financial impact of this dreadful disease is mitigated by support from our healthcare system instead of largely ignored by it. I will make it my mission to tell my story until Lyme and other vector-borne illnesses are taken seriously. Pediatricians and providers need to know that 70 pound children who are very ill and suddenly develop "stretch marks" on their backs may have bartonella. Education is essential. I might have had a very different adolescence. I would like to be able to spare other children the fate I faced. That is my goal. Ticks are not going anywhere, so it is up to us to make the changes.

Sincerely,

Anonymous

[REDACTED], New York

----

## Samantha

Hello,

I am a Chronic Lyme Disease patient and a Health Care Leader. I am working on my Master's in Health Leadership, a peer mentor for other patients with Lyme Disease through the Global Lyme Alliance, and the Sr. Operations Manager at a Health Tech company. My mission is to ensure that Chronic Lyme Disease patients have access to improved outcomes and improved quality of life.

I contracted Lyme Disease in Northern California in 2011. I do not recall seeing a tick or a bull's eye rash, however, I did have a rash and typical early Lyme Disease symptoms. I went to the doctor, but Lyme Disease was never brought up. I went undiagnosed until 2014.

During those three years, I lost the ability to eat or drink, I developed migraines, asthma, joint pain, nerve pain, and chronic fatigue. I was on TPN. It was discovered that I had severe gastroparesis (unknown cause). I got sepsis twice. What eventually led to the diagnosis of Lyme Disease was that both times I got sepsis, I improved on antibiotics. Not only did the infection clear, but I started to be able to drink again. Sadly, the course of the antibiotics was short (10 days for the first time and 30 days the second time) and so were the benefits of treatment. Once I was off antibiotics, I started to get worse again.

This was unexplained. No doctor knew why all my symptoms would improve on antibiotics. However, when I was tested for Lyme Disease, I tested positive using the Western Blot test. I have improved on antibiotic treatment, but I continue to have long-term symptoms.

I am not able to eat and drink on my own. But I have very severe asthma and migraines. I am still unable to walk on my own and I suffer from Common Variable Immune Deficiency.

I was sick, but due to a lack of education about Lyme Disease and chronic Lyme Disease, in particular, I was not tested for Lyme Disease. The clear signs of a bacterial cause for my symptoms were missed and/or overlooked. Our healthcare system can and MUST do better.

A chronic-Lyme designation is critical to fuel the additional research that is necessary to understand Lyme Disease more fully and recommend treatment protocols for chronic-Lyme disease. A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease. Patients need more accurate testing, better treatments, and access to treatment (i.e. insurance coverage) in order for our nation to heal.

I am asking the TBDWG to recognize and recommend a chronic designation of Lyme disease.

Sincerely,

Samantha

----

## Mary Kay Stensvad

My name is Mary Kay Stensvad and I’m 61 years old. I have had chronic Lyme disease for at least four years but was not medically diagnosed until September 2019. I am very sick. This disease is chronic, and it is real. I personally know others with chronic Lyme Disease who are also very sick. We deserve better treatment from the U.S. Government, from doctor ignorance, from public shaming that surrounds this disease, and from our insurance carriers.

I unknowingly contracted Lyme Disease when I lived in San Diego, CA. I never saw a bullseye tick bite. The Lyme parasites ruthlessly attacked my spinal cord. Since then, I have lost most of the normal feeling from my waist down, I lost the ability to walk without the aid of a rollator walker, I lost the ability to control my bladder and my bowels, I lost the ability to drive, I lost the ability to work outside of my home, and I constantly experience excruciating pain and burning in my lower back, legs, and feet. Because of the rapid onset of my physical disabilities, my 30-year-old son had no choice but to quit his job to be my caretaker so that my husband could continue to work outside the home.

We moved to Charleston, SC two years ago. Since then, I have been to seven Charleston doctors and a transverse myelitis specialist at [redact]. None of them could diagnose the cause of my neurological symptoms. I have had multiple lumbar punctures, at least a dozen MRIs of my back, and an untold number of lab tests. Everything came back normal and the neurologists at the [redact] South Carolina told me that they were “scratching their heads.” During all of this testing, I repeatedly asked them to test me for Lyme Disease using the [redact] Lyme test because my online research led me to believe that’s what I had. They all looked at me like I was crazy. The Infectious Disease doctor told me that, “we don’t have Lyme Disease in Charleston,” to which I told them him that I am not from Charleston. He finally agreed to test me using the government-approved ELISA test because he had no idea what was causing the transverse myelitis. The ELISA test came back with a false negative. I then asked all of my doctors to please draw blood for the [redact] Western Blot test, which I would pay for out of pocket. They refused.

Finally, in the Fall of 2019, I went to a well-known Lyme clinic and my [redact] Western Blot test came back with all double positive bands for Lyme disease. I immediately sent the results to my doctors in Charleston and they did not want to discuss it with me. Instead, they wanted to run more tests on me; the same tests that had repeatedly come back normal. I declined and went back to the Lyme Clinic for two six-week Lyme Disease treatments. While there, I met other Lyme Disease patients; some were young children who couldn’t walk, talk, or go to school. This is wrong. The U.S. Government has got to acknowledge the unnecessary pain they are inflicting on our children and their families and provide whatever it takes to research and cure Lyme Disease.

My insurance carrier, [redact], has refused to cover any of my Lyme treatments. All totaled, I have spent about $50,000 out of pocket to be treated for Lyme Disease. I have had to take money from my 401K and borrow money from family members, all because [redact] is allowed by the U.S. Government not to cover Lyme disease. If I had cancer, AIDS, MS, or any other chronic disease, [redact] would be required to cover it. This is wrong, and it’s clearly U.S. Government and insurance carrier discrimination against Lyme patients.

I am still suffering with chronic pain and the inability to walk. I am on multiple medications in an attempt to control my symptoms and keep the Lyme parasites in remission, but many days are spent lying on my stomach with an ice pack on my lower back.

I have a new neurologist in Charleston who has other Lyme Disease patients. He is working hard to keep me from getting any worse. He prescribed nonstop physical therapy every week, but [redact] repeatedly makes me wait for weeks before they authorize more physical therapy sessions. My neurologist recently wrote a letter to [redact] in hopes of having them stop this practice of making me wait. This is wrong of [redact] because I lose some of the ground that improved with my physical therapy sessions.

I am respectfully asking that the Tick-Borne Disease Working Group (TBDWG) recognize and recommend a chronic designation of Lyme disease, which would ensure that countless Americans, including our children, are provided proper diagnosis and treatment of this awful disease. Accurate testing, insurance coverage of this disease, and public and employer education and recognition of this disease would go a long way towards preventing, curing, and eliminating this horrible disease.

Thank you for your compassion and consideration.

Sincerely,

Mary Kay Stensvad

----

## Mary Ellen Lincourt

Symptoms of chronic Lyme continue to plague me: **July 11, 1974, my world came crashing down.**I felt extremely ill, as if I were having a heart attack.

In the hospital I was given Valium and sent to the psychiatrist because there was no evidence of a heart attack.

Post laparascopic surgery, March 7, 1974, I had been taking Clomid to stimulate my “lazy” right ovary to ovulate.

Unknown to me for the next 37 years I was dealing with a host of stealth pathogens the synthetic	estrogen Clomid prompted to grow out of control in my body.

After much misery, panic attacks, sore feet when I got out of bed in the morning, painful and swollen joints, infertility, multiple chemical sensitivities, seasonal depression (spring time), trouble breathing, and unexplained arrested breathing at 4 or 5 am which would wake me up terrified, I was **diagnosed in 2011 with Lyme, Babesia and Bartonella.**

That was only due to a friend who had contracted Lyme and had experienced my chemical sensitivities to exhaust on her plane flight back from the Dominican Republic where she had been bitten by sand fleas.

My treatment, 2 years of multiple antibiotics, was unsuccessful and stopped when Malarone made me more chemically sensitive.

More recently I tried a very expensive (all out of pocket) homeopathic regimen to treat Lyme, Babesia, Bartonella, giardia, cytomegalovirus, mycoplasma pneumonia, H. pylori, Ehrlichia, Rocky Mt Spotted Fever, Rickettsia.

That treatment was painful and very unsuccessful.

I still have residual Lyme, Babesia and Bartonella.  I notice the tell tale Lyme cycle changes in my feces and swollen and painful arthritic joints.

**I use the GB 4000 Rife Machine and detox footbath to remove**excess toxins as well as prescription DMSA to keep mercury levels under control.

The rabies numbers on the rife machine help the most along with all the detoxification numbers.

Due to a very limited diet of nutrient dense foods, no sugar, no dairy, no grain, no night shades, no molds, I am able to maintain some mobility.

I walk unsteadily with 2 ski poles to assist me.

**I have not been able to FEEL my feet of legs since 1999**, but if I hit them or fall or step on something, the pain is excruciating.

My right hand will no longer hold a pen, play the right notes on the piano, or open a jar, even the most simple.

I cannot use nail clippers or tweezers.

My hand will not squeeze them.

When a lose my balance I can no longer recover quickly by taking a step.  I cannot run after my grandchildren if they run into the road or fall in the water.

My most recent Lyme test showed only one band 41, so my health care provider will not prescribe any Lyme treatment.

Chronic Lyme is very real.

I live with it every moment of every day.

I am in pain most during the night and when arising.

Exercise is limited to walking and swimming (summer only).  I am allergic to chlorine.  I fell 6 times between June and August and it took weeks for the pain in my knees to heal.

I am trying physical therapy, but I cannot tolerate the perfumed sanitizers.  I cannot breathe with a mask and exercise.

**I calculate I would have earned 1.5 M**, if I had been able to teach for 35 years.  My husband supported me.  I had to “retire” after 2 years, because I was so “sick.”

We are both 71 now and retired on a very fixed income.

[Redacted]

Mary Ellen Lincourt	Eastbrook, Maine

----

## Monica White

I have participated as a subcommittee member for the TBDWG for both the 2018 report to congress, as well as the 2020 report to congress. I have attended each and every WG meeting from start to finish for going on 4 years. Formerly a fully functioning professional wildlife biologist, this work drained me, and it took me months to recover from each effort. I am not a malingerer...but, a passionate and dedicated advocate doing the best I can to be a part of the change needed to prevent others from experiencing what I have experienced. But we must be acknowledged. We must be the priority. In addition to working on two separate subcommittees, I have repeatedly provided written public comment to the Working Group. I have lived with chronic Lyme disease, I have cared for children and a husband with chronic Lyme disease, and as an advocate I provide support and woefully inadequate resources for a growing number of patients faced with diagnosis or access to care for chronic Lyme disease.
                          - People are sick. And, they deserve better. The stigma, doctor ignorance and public shaming that surrounds this disease needs to be rectified.
                          - A chronic-Lyme designation would ensure that countless Americans are provided proper diagnosis and treatment of this disease. 
                          - We are seeking access to accurate testing, insurance coverage for this disease, employers recognizing that this is real. 
                          - We ask the TBDWG to recognize and recommend a chronic designation of Lyme disease. 

Please review my story again....see the face that goes with the story. Mine is one of just hundreds of thousands of sufferers. https://www.lymedisease.org/monica-white-tbdwg-comments/ We are real people, some with full productive lives prior to falling ill and remaining ill with chronic Lyme Disease, others that never had a chance as illness hit in childhood. Exhausted physically and financially we continue to fight to be cured and for the need for the disease we face to be recognized....chronic Lyme disease. The only way forward is to name the disease we are fighting. 

Thank you!

Monica White	President/Co-Founder	Colorado Tick-Borne Disease Awareness Association

----

## Sarah Pierce

My name is Sarah Pierce.  I live in the state of Colorado.  I have chronic lyme, and I demand that my voice be heard.  The following is a brief history of my chronic lyme story.	About 8 years ago in the month of July I came down with severe body aches, high fever, chills, and severe night sweats.  I was sick with a high fever for two weeks.  In that two week period  I visited the doctor and requested a lyme test.  I was told that it was impossible to get lyme in Colorado and told they wouldn't do the test.  After I "recovered" I was extremely fatigued for weeks.  I never fully recovered and every spring/summer would have a flair up where my blood pressure would drop, I would be extremely dizzy, fatigued, and nauseous.  Fast forward to July of 2019.  I hit my head and suffered a concussion with symptoms of extreme vertigo, nausea, light sensitivity, fatigue, and headaches.  I was completely immobile for two months and slowly started to feel "normal".  I felt okay for about two months and slowly started to get all my symptoms again with a vengeance.  I again started to go to the doctor with questions as to why I'm not getting better.  My neurologist and primary care doctors both thought I had dysautonomia.  With growing concerns that something was being overlooked I continued to look for other opinions.  I found another doctor who highly suspected lyme and ordered a blood test.  My blood test came back positive.  I took the results to my primary care doctor and was met with extreme resistance, I was devastated!  I was told there is absolutely no way I got lyme in Colorado and that I should get another test to confirm my results, even though my doctor agreed that I had all the symptoms of lyme.  So now I found myself for the first time in my life completely loosing trust in my primary care doctor all together.  In fact I am now forced to take all the research into my own hands because of the misinformation the CDC is pushing.  This is a massive problem not only in Colorado, but in EVERY state.  Since my diagnosis I have discussed my situation with a lot of people in my community who have lyme and they also say the got lyme here in Colorado.  My question is why is it so hard to believe that lyme is in Colorado?  There has been a published case of lyme being transferred by a biting fly in the New England Medical Journal, still everyone is narrow-mindedly focusing on ticks.  Why is lyme so controversial?  We have so many diseases that are diagnosed every day that are based on symptoms alone, including Parkinson's and  psychological diseases.  You can actually see lyme under a microscope and in some cases you can confirm symptoms with a blood test.  More needs to be done, at a absolute minimum, QUIT telling people that chronic lyme doesn't exist.  That is an absolute disgrace to our medical system, and makes a blatantly obvious statement that there is corruption in the CDC.  Just think, if I would have received proper treatment at the time I first was infected, my chances of being cured were extremely high.  NOW my chances are very small.  I try really hard to not think of that now, as it's too late.  But it's not too late to put emphasis on research, and at a minimum start recognizing the growing epidemic of CHRONIC lyme, of which, in my opinion is not disputable.

Sarah Pierce	Oak Creek ,CO

----

## Chris Fuentes

To the Distinguished Members of the Tick-Borne Disease Working Group,

I am writing to you today as the founder of  [REDACTED], a company whose declared mission is to stem the alarming increase of vector-borne diseases caused by ticks and mosquitoes.  With five grandchildren between us, my business partner, Ted Kesten, and I are dedicated to inventing a ‘better ingredient repellent’ so that our future generations are protected from devastating tick-borne illnesses. Living at the epicenter of vector-borne diseases, just 50 miles down the road from Old Lyme, Connecticut, we have personally witnessed how hundreds of close friends and family have been impacted by tick bites, and our sincere goal is to prevent those devastating illnesses from happening in the first place.

**Regarding the Use of Repellents:** The 2018 TBDWG Report to Congress clearly states that, while there is an abundant number of safe and effective repellent options available, people are reluctant to use repellents as the first line of defense and that ‘barriers persist’, requiring more research. Two years ago, as a one-year start-up, we took that as a call-to-action and have done extensive research to learn why the American population as a whole is reluctant to use safe and effective insect repellents.

**Research Discovery:** In two independent and separate research studies of frontline workers - Registered Nurses and Pharmacists - we have been able to more clearly answer **why** and **what** barriers exist.  We have discovered a large knowledge gap in frontline workers’ understanding of repellent active ingredients and the proper use of repellents.  Research indicates that accredited training for professionals on repellents is nearly non-existent, and that most medical professionals gain knowledge on repellents from online research that is rooted in information that is outdated or incorrect.

**Steps Forward:** First, in August 2020, our company announced the development of a nationally accredited, widely available, Continuing Education program to better inform frontline workers and other professionals on the proper use of repellents. Our intention is to provide accurate information to professionals and break the cycle of our kids being bitten.  Second, the information regarding the proper use of repellents needs to be updated to reflect the most effective world standards for similar products. There is clear and sufficient evidence that consumers are confused about what active ingredient to use and how much active is required for effective protection from bites. And third, that each state has an opportunity to improve its repellent program offerings to better serve their residents. A simple step forward is to make repellents FSA eligible, which our company has appealed for without success thus far.

**Heighten the Sense of Protection from Tick-Borne Diseases:** By directing resources towards proper protection and preventative practices, we can effectively reduce the number of cases of tick-borne diseases and save lives. People **must** improve their personal protective measures, or the cost and human suffering will persist.  Particularly in the Spring of 2021, we estimate that Americans will emerge in unprecedented numbers to garden, hike, walk their dogs, camp and be broadly susceptible to ticks bites.  A federally supported public service information campaign would serve to protect our nation from bites that cause long-term illnesses. 

Thank you for all of the hard work you do as public servants, volunteers and professionals.

Sincerely,

Chris L. Fuentes - Founder and Chief Executive Officer

[REDACTED] - Norwalk, Connecticut

----

## Anonymous 28

Wisconsin has one of the highest rates of Lime disease yet little is offered to prevent or treat it. More needs to be offered and the sooner the better. My nephew's life is essentially wasted because of it at 61 years of age.

Anonymous

Content last reviewed January 12, 2021