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                              TBDWG September 12, 2019 - Written Public Comment


    

    

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TBDWG September 12, 2019 - Written Public Comment








  
  
    

  
      





This webpage displays the written comments received by the Tick-Borne Disease Working Group for the September 2019 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 have Lyme disease. 11 bands on Western blot positive, and ELISA test too. 2 pc's and 1 Infectious disease doctor said I don't have lyme. Even the lab and the hospitals said I have Lyme. I'm I'll. I had to take a leave of absence from my job. I need a doctor who will take these tests seriously and work with me. I've been offered counseling and lots of antidepressants and sedatives, but no help at all figuring out my Lyme disease. I am 66, on SS, and need to be able to get back to work and I can only afford to go to doctors who will take my insurance.
Having doctors look at you like you're crazy and offering those kinds of meds makes me sick. It destroys my confidence in the medical industry. Are all doctors hush hushed by the CDC? Why is it so hard to get help? They can't even answer my questions, just tell me I don't have Lyme.
I won't and can't go to a so called LLMD, not sure if there not all just pushing pills and tonics and supplements that may work, but differently for each individual. I hope the doctors soon start learning more about the disease and the CDC needs to stop clamping down on how they treat.
Thank you.
Anonymous 2
I have had alpha gal and lyme disease for 7 years now. I suppose I will live the rest of my life being sick and receiving inadequate care, mainly because the doctors say that alpha gal is so rare, they have never seen a case and because no doctor takes lyme seriously. They just don't believe me, either about AG or Lyme. They say it is not possible. I have had blood work done, but my numbers are so low that supposedly I am negative for AG. I had one doctor ask me if I had ever been to the NE United States. I had not, so I told him no. He said, well, you do not have lyme then. You can only get that up in the New England states. So you see, when I go to the doctor and have to go to the ER, they try to treat me using standard protocol. I cannot be just given medicines and contrast solutions, IV infusions and other things without them being thoroughly checked for mammal ingredients. Every time I go to the doctor or the ER, I run the risk of being seriously hurt. I have to go to an allergist over 60 miles from my home, because he at least knows about AG. The allergist I have here in town thinks I am *overreacting*. You mean, overreacting when my neighbors next door are cooking their meat on the grill and when I walk outdoors and the fumes hit me, it feels like I have been snatched up by the throat and I start having trouble breathing. Their grill happens to be on their porch, which is on my side of the house. It happens when I go to the grocery store and they are cooking bacon. There are days I am afraid to even leave my house. But I have to earn a living, otherwise I will not have a house. I have missed days at work due to being sick with lyme and having a *flare*. I already had to quit one job because of Alpha Gal. My job was right next door to a restaurant and their pot roast night and burger nights made it impossible for me to keep that job, as the fumes wafted over into my store. Twice while I worked there, I had to leave in a rush and go to the ER. My life has been ruined by that one little tick. I cannot live normally any more.  I live in a constant state of apprehension and fear, because I like to breathe. This allergy threatens to take that and my life away from me, every time I walk out my front door.
I realize that everyone has problems, that everyone has illness but these ones are becoming such a problem to so many people because of ticks moving to areas they have never been before. This problem is only going to worsen, with more people becoming sick. We need research, answers and cures. Thank you for your time and hard work.
Lucy Barnes
People can be infected with more than one tick borne disease organism. One study indicates over half of the Babesiosis patients also have Lyme disease. Hunters, fishermen, park employees, farmers and those spending a lot of time outdoors are more at risk for contracting the disease. People can have Babesiosis (over 100 known species) and not realize it if symptoms are mild and fleeting. Often though, there can be a sudden onset of symptoms- coming, as described by patients, from "out of no-where".
Several studies have supported the literature stating ARDS- Accute Respiratory Distress Syndrome- can be linked to Babesiosis. In a 1984 study a transfusion induced Babesiosis/ARDS patient died from the condition. In a 2012 study a Babesiosis/ARDS patient was successfully treated, however, six years later in a 2018 study, 3 out of 8 patients with Babesiosis related ARDS also died. It was also reported in a 2017 study that the "degree of lung injury was severe in the majority, and multi-organ dysfunction was the norm."
**"ARDS often followed the initiation of anti-babesia drug therapy"**. This is reminiscent of what many patients have been reporting for years as part of a severe herxheimer-like reaction.
Babesia duncani (aka WA1) has been detected in patients on the west coast (USA) where it was first discovered. However, doctors have been finding WA1 infected patients across the USA and overseas. Some of these patients are also infected with the Babesia microti and other strains.  For example, in Maryland, the WA1 strain (Babesia duncani) is being detected in human patients approximately 5 times more often than the B. microti strain.
Babesiosis Study (2019)- Persistent and chronic infections, relapses, transfusable and serious. https://www.ncbi.nlm.nih.gov/pubmed/31319461
Babesiosis is also known to be transmitted by infected donors to those who have received a blood transfusion or organ transplant. Beginning in the early 1980s, cases of transfusion-transmitted Babesiosis were reported sporadically, but cases have steadily increased in frequency over the past 30 years, with at least 12 fatalities in transfusion recipients diagnosed with Babesiosis.
Babesiosis has also been shown to be transmitted transplacentally or perinatally. Infected infants have developed Babesiosis at 26 days to 5 weeks of age.
**Symptoms**
**Babesiosis Symptoms: (Some are described by patients in their own words.)** The parasite that causes Babesiosis invades and then destroys red blood cells. It can cause a malaria-like (relapsing) illness which can become chronic and/or can be fatal (10%- 28% fatality rate).
Symptoms may appear slowly or have a sudden onset, or may take months to years to fully develop. There can be "flares" of symptoms every four to six days, or on an on/off basis. Symptoms can plateau and return full force at a later time.
Symptoms **can** include dizziness, depression, acute respiratory distress syndrome, feelings of being off-balance, chronic cough, intermittent fevers, fatigue that worsens with exercise, severe fatigue, nausea, anxiety, chills, non-typical symptoms related to the head, low back pain, appetite swings, waves of sweats at night that can also occur during the day.
Babesia patients may experience de-ja-vu feelings, mood swings, vision and focusing disturbances and/or eye orbit problems, soreness or pain on the top of the head, sensitivity to light, "weird" feelings (confusion, panic, jittery, nauseated, "got to get out of here" thoughts, light-headed, claustrophobia, etc.) especially in areas with florescent lighting (malls, hospitals, stores, offices, etc.).
There can be disturbances in autonomic nervous system, vasculitis, concussion-like symptoms, an overstimulation of the brain, enhanced senses (everything is more intense), headaches (often pressure headaches- often behind the eyes- can feel like head is in a vise), focal vasculitis, exaggerated startle responses and headaches that feel like you are experiencing moving sensations.
Malaise, feeling "unstable", personality changes, feeling as if in a "fog", numb spots on head, drenching night sweats, delayed responses to questions, memory and cognitive disorders, muscle pains, irritability, temperature intolerance, racing heart and/or irregular heart beat (often worse at night) and breathing difficulties (air hunger- need to sigh and take a deep breath) are possible symptoms. Patients with Babesiosis may also experience orthostatic hypotension, various uncomfortable feelings, episodes of vomiting, suicidal thoughts, panic disorder, hypercoaguable states (thick blood), mild to very severe insomnia and obsessive compulsive disorder (OCD).
They may have wrist and hand pain, dehydration or swelling, pain in feet/ankles, bleeding tendencies, acute respiratory distress syndrome, severe fluctuation of temperature, unexplained weight gain or loss, dark colored urine (blood in urine), anemia, swollen spleen (can rupture in some cases), enlarged liver, attention deficit disorder (ADD), vivid dreams and nightmares, congestive heart failure, respiratory failure, renal failure, bruising, jaundice, pulmonary edema, myocardial infarction, anorexia, evidence of shock and encephalopathy.
Symptoms can range from mild to severe. They can limit a persons ability to do everyday chores, their jobs and they can negatively affect their life in general. Driving, playing sports, operating machinery, walking a straight line, grocery shopping, attending family functions, being in a room with more than one person speaking and even cooking a meal may become difficult, if not impossible.
Most doctors are not familiar with the diagnosis, wide range of symptoms or treatment of Babesiosis (and they really SHOULD be). Babesia can be found in biofilms.  Chronic Babesia infections can cause multiple symptoms and enhance the severity of Lyme, but patients may not present with detectable hemolysis (rupture or destruction of red blood cells). In more severe infections there is persistent, but very low grade hemolysis which can lead to iron deficiency over time.
Babesia infections can raise carbon monoxide levels which in turn can add to or even cause environmental sensitivities. This is an often overlooked clue to the presence of this bug.
**Treatment**
**Babesia Treatment:** A combination of Atovaquone/Mepron, 2-4 teaspoons per day (1-2 teaspoons, 2x per day) with Zithromax or Biaxin, is a common treatment for Babesiosis. This combination is reported to have less serious side effects than quinine and clindamyacin.
Eating fatty foods (bacon, ice cream, etc) while taking Mepron has been reported to increase absorption of the drug. Some experts feel for Mepron to work you have to push the dose- 1 teaspoon for 5 months minimum (some say 9 months minimum)- and it must be taken with a large amount of fat. In absorption studies the test subjects had 23g of fat with each dose.
The cost to treat Babesiosis with Mepron/Zithromax can range from approximately $1,800- $3,600 per month.  The duration of treatment has recently been increased to a minimum of 5 months, often requiring 9 months to eradicate the organisms in early cases. In some patients recovery was not seen until five years into treatment and relapses are fairly common.
**Congenital Transmission of Babesiosis**
**2018-**"...2 infants with congenital babesiosis born to mothers with prepartum Lyme disease..." https://www.ncbi.nlm.nih.gov/pubmed/28992325
**2015-** "Four ... of five infants with congenital babesiosis whose neutrophil count was reported were neutropenic." https://www.ncbi.nlm.nih.gov/pubmed/26071466
**2010-**"Congenital babesiosis in a four-week-old female infant" https://www.ncbi.nlm.nih.gov/pubmed/20118748
**2009-**"... third congenital case of babesiosis in a 26-day-old infant; transmission was determined on the basis of a blood smear from the infant (15% parasitemia) and serologic results from the infant and mother." https://www.ncbi.nlm.nih.gov/pubmed/19402971
**2006-** "Neonatal babesiosis: case report and review of the literature" https://www.ncbi.nlm.nih.gov/pubmed/16462298
Lucy Barnes
	Lyme Disease Education & Support Groups
Dana Dew
I was diagnosed with rmsf in may of 2018. I remember the tick bite because it was about 8" in diameter but I thought it was because I was scratching it so much. My brother n law was in the hospital in little rock dying at the time and every day I had off work I drove the 2 hours to be with my sister. I started noticing my left arm feeling real tired and heavy. That's the hand I drive with so I just thought it was from exhaustion. Then, my left eye started twitching and it wouldnt stop. It was driving me crazy. I got off from work one night and while eating dinner with my husband i noticed my left leg was hurting. I thought i had just pulled a muscle at work. I had a very strenuous job as a waste water treatment operator for future fuel chemical co. The next morning my alarm went off and i tried to get out of bed and couldnt. I was in excruciating pain down my whole left side. I was balled up in a fetal position and my husband rushed me to the er. The dr came in, examined me and was going to give me a steroid shot and send me home. That really upset me. No tests or anything so my husband insisted on an xray and something for pain. Against his better judgement the dr complied. The next morning was no better so my husband took me to little rock where they told me the same thing about an MRI. That it had to be ordered by my pcp before insurance would cover it. They gave me a shot of tramadol and sent me home. This was on a Sunday. The following Monday morning I had my sister drive me to my pcp which couldnt get me in till later in the afternoon. He ordered mri's and found some mild things with my neck and back and sent me for physical therapy. All the time through this my blood pressure was 153/100. I was doing physical therapy one day and felt like I was having a heart attack so I immediately went to the er and they said my heart was fine but to follow up with my pcp. I did and my husband accompanied me. This was 2 months of being completely bedridden. My husband asked the dr if this could be cause from a tick. He said yes absolutely. So he did a tick panel and 3 days later the nurse called me in some doxycycline. By this time the damage was already done. Every step I took it felt like my muscles were tearing inside my leg. My husband asked the dr if he could order some muscle or nerve tests and he complied. My emg showed abnormal. Acute/ongoing motor neuron axonal loss. I am completely disabled now. Have had several procedures and injections on my back to no avail. I was referred to a pain management clinic from my neurologist and the first visit they had me pee in a cup. I had been taking hydrocodone for pain and valium for muscle twitches. The pain dr said I was going to have to come off one or the other. I chose the valium because my muscles were still twitching anyway. So I quit them that day. Then they call me to tell me my urine had came back positive for oxycodone which I have never taken in my life so I told them they had to have gotten my pee mixed up with someone elses and I was going to go get a hair follicle test done even if I had to pay out of pocket for it because this was their mistake and it's not just a little mistake. This could potentially ruin my life. I am on long term disability awaiting a hearing for social security disability so I'm hoping this mistake doesnt have any effects on that because that is my only source of income for my part of the Bill's. My husband doesnt make enough to cover it all. This is the kind of treatment we are all getting. Now I am on blood pressure meds, cholesterol pills, 2 different antidepressants because I've always been active and now it's almost impossible for me to make it through a grocery store. I have to start on a cpap machine tomorrow because I had an abnormal sleep study with 111 occurrences of breathing issues and 37 leg movements. (Those are the twitches I was talking about.) Its enough to drive a person crazy. I dont remember the last time I slept all night without waking up in pain, muscles twitching, or unable to breathe. I'm thankful to be alive because I now know of a lot of people who died from this however, at one point I prayed for God to just call me home. The pain is unbearable.
Dana Dew
Sharon Forsyth
Dear members of the working group,
Thanks for giving me the opportunity to tell my story and express my concerns. I was bit by three ticks within a week in early May. On May 22nd, I experienced anaphylaxis a few hours after eating a hamburger. I ate meat two more times, and experienced anaphylaxis two more times. Shortly afterwards, I was diagnosed with Alpha-gal Syndrome.
As I rarely ever ate red meat, I was not too concerned about giving it up. In fact, I thought it might be a positive change. Little did I know that my life was about to be upended. It turns out that I am highly reactive to trace amount of alpha-gal. I even react to the fumes of cooking meats. I had to give up not just red meat, but dairy, gelatin, and carrageenan, yet still I get sick on a regular basis, because it is almost impossible to figure out which foods are contaminated with mammalian byproducts, which is even in staples, like sugar and some water--both of which often contain mammalian bone char.
Even worse than the daily battle to avoid foods contaminated with mammalian byproducts is the impact that AGS has had on my health care. My dentist told me that he can no longer treat me, because he can't figure out which dental products I might react to. I have had to stop taking several medications, because they seem to be contributing to my stomach aches. I don't know what to replace them with, because my doctors can't figure out what alternatives don't contain inactive ingredients that might affect me. But worst of all, I live in mortal fear of a broad range of medical services that might cause me to experience life-threatening reactions: vaccines, IV fluids, heparin, a host of other medications, pharmaceutical and medical products. I don't even know which ones are very dangerous for me and which ones pose a small risk--that information simply isn't available. I'm overdue for colonoscopy, for example, but I wouldn't dream of getting one at a local hospital (I live in DC) where I can't count on the anesthesiologist and whoever else is involved to know what's safe for me. I guarantee they will never have heard of AGS, or if they have, they will think that all I need to be safe is not eat red meat.
Here's what Congress could do to help me and the thousands of others like me, many of whom are not literate enough to write and ask you for help:
Fund efforts to raise awareness and educate physicians, hospital staff, pharmacists, and students preparing to enter healthcare professions.
	Fund a National Drug Information Hotline, to help pharmacists and physicians determine which drugs and other medical products are safe for us. A regional hotline, based at Rutgers in NJ, already exists, but they are overwhelmed and only operate on weekdays. A national hotline wouldn't even cost much, and could be modeled on the existing, regional one.
	Pass legislation requiring that ALL foods and ALL medications be labelled --indicating whether they contain mammalian derived products or not. If further research is needed for this to happen, prioritize funding for the needed research. As an aside, I've been told that labelling hasn't happened in part because AG is not a "Big 8" allergen. But look at the research on anaphylaxis. In some areas, AGS is the number one cause of anaphylaxis --at 33% of cases with a known cause compared to 24% for ALL OTHER FOOD ALLERGIES COMBINED. Given the deadliness of our allergy, doesn't it merit the same attention at more prevalent ones?
	Federally regulate the term "vegan." For Pete's sake, can we at least count on food labelled "vegan" to not make us sick? Is that too much to ask? Probably most food labelled "vegan" is vegan, but should we have to just hope it is?
	Require airlines to keep epipens on their planes. People with AGS experience delayed anaphylaxis. There have already been documented cases of people with AGS almost dying due to lack of epipens on planes.
	Fund research on the alpha-gal epitope and related illness. This is obvious, I hope. There is much we still don't know about it, and other potential carbohydrate epitopes. The implications go way beyond just the subset of us who experience full-blown allergic reactions. What about the other folks who test positive for AG IgE--up to 22% in some areas? Are they really unaffected, or are they experiencing subclinical inflammation, etc., as the research on AG IgE levels and arteriosclerosis might suggest? What role might AG IgE, and possibly other carbohydrate epitopes, play in the rise of other allergies and autoimmune disease? Shouldn't we find out?Thanks for listening. May Congress be as generous with you when it's your turn to speak!
Sharon Forsyth
Tammy Godfrey
I am 49 years old and was diagnosed May 2019 with Rocky Mountain Spotted Fever and Lyme's Disease. I have suffered for the last 2 years with sickness. I have been to numerous doctors, lots of tests and even one surgery trying to find out why I haven't felt like ME! I have been told by doctors they thought I had MS and strokes. I have headaches, neck pain, vision problems, night sweats, fever (everyday), rashes, tingling and numbness in my left foot and hand. I have no appetite, feel nauseous, anxiety and depression.
There have been days I feel so bad I have thought about not being here. I have no emotions/feelings.
My body aches when I try to sleep. I don't get a full nights sleep anymore.  I can't perform my job like I once did. I feel I don't fit in anymore. I don't want to be around people, therefore my relationships with family and friends have diminished.  People tell me to shake it off.  I wish that it was that easy.  I have no HOPE left.
Please listen to us as we pour out our pain and plead to you that we need help.  More awareness, I feel like i'm dying. I have told my family that so many times.
Sincerely,
Tammy Godfrey
Catherine Johnson
I live in Minnesota, well known as a highly endemic state for Lyme and tick-borne illness. My experience spans from the first nymph tick attached to me surrounded by a bulls-eye rash in '09. At that time, I only had heard something about a "target" mark to look for if you are bitten by a deer tick and to save the tick. I did save the tick but didn't know why. I had a doctor appointment some time later because I wasn't well, problems with my stomach and rapid weight loss. My doctor ran some blood tests. I mentioned the tick I had on me with the "target" mark and suggested a Lyme test. She said "Really?" but agreed to order the test. It came back negative and we both agreed "oh good, at least you don't have Lyme". So it went untreated. This is not on the radar of most physicians and if you test negative without very specific symptoms to make a clinical diagnosis, then you don't have it. That's about it, right? You could have sold me on that the rest of my life if I hadn't been bitten again in the summer of 2017. Two nymph deer ticks attached side-by-side, one engorged. I still had almost no knowledge about Lyme disease. This time there was no bulls-eye rash so I thought they weren't the kind that carried Lyme. I totally discounted them and went about my life. A few weeks later, mid-July, I got the flu. I missed a couple days of work and started to feel better. I went to work, profusely sweating all day but thought I was just sweating out the flu. That night a rash began to develop from my scalp down to my legs, everywhere. I still did not put the pieces together because I had no knowledge of flu symptoms or absence of a bulls-eye. I thought I was having a major allergic reaction to something until two ER triage nurses said it looked like Lyme to them. I started with the "yea...but's" but after hearing some explanation, the piece's came together, my head dropped, I knew I was in trouble. It took four months but I finally got a CDC positive Lyme test for Borrelia Burgdorferi. My road with this has been the hardest challenge of my life. The first years between '09 and '17 as I got more and more sick with no known cause was devastating to my life but to have it happen again this time knowing what it is, doesn't make a difference because there is no treatment available to someone without financial means and it seems surreal to people when you try and explain it all, eye's glaze over. Chronic Lyme Disease is real, it's painful, scary and no one can tell you if you'll get better, die or somewhere in between. This is how I personally know. I was energetic, healthy, slept well, physically in good shape and it all suddenly changed between the two times I pulled ticks off of me. Sudden drastic change. I'm 2 years into my own research with scientists, professors, doctors in the field. I've learned some ugly truth's about how people's suffering is coming off as a political matter surrounded in controversy. I have my own opinion about it all but if 300,000 new cases a year do not grab urgent attention, then more is going on than meets the eye. Does the TBDWG talk about the Texas lawsuit and its implications? Is it considered in your work and how it may require a need to adapt your vision moving forward should the lawsuit be won, with most certainly more to follow? There is good science out there but funds don't seem to reach the right scientist's. I was told by one of my physicians, an awarded doctor of rhuematology from the U of M who was involved in the second attempt at developing a Lyme vaccine, that the truth is: there are no reliable tests or treatments for tick-borne illness right now. They just aren't there. He hopes to see them before he dies. I hope to see them before I die, too. I can't understand why almost no one I talk to about Lyme in Minnesota does not know how bad this is and in our own backyards. It has been reported recently the first cases of Powassan were found in 6 counties that happen to surround mine. Shouldn't this be shouted from the roof tops here by now? I can only imagine what it would have been like to have had the heads up for prevention alone. If some states are requiring insurance companies to treat Lyme disease, why not all states? There is no sense to it and I think the curtain is finally being pulled back about that now.
Catherine Johnson
Lorraine Johnson
**Concerns Regarding the Lack of Balance on the Tick-Borne Disease Working Group**
I am writing on behalf of LymeDisease.org and 57 other advocacy groups who represent Lyme patients throughout the United States. We are deeply concerned about the lack of balance on the newly appointed Tick-Borne Disease Working Group (TBDWG).
Under FACA rules, the Working Group is required to be "fairly balanced in terms of the points of view represented and the functions to be performed." In balancing committee memberships, agencies are expected to consider a cross-section of those directly affected, interested, and qualified, as appropriate to the nature and function of the advisory committee.
The primary people affected by the Working Group are patients with Lyme disease and the clinicians who treat them. These are the people who worked to include the TBDWG in the 21st Century Cures Act. And these are also the people who are denied care, denied insurance coverage, and whose treating physicians are targeted by medical boards. Yet patients and their treating clinicians are not adequately represented on the 2019 Working Group.
The 21st Century Cures Act provides that “the Working Group will consist of 14 voting members, including the Chair, who represent diverse scientific disciplines and views.” It provides that the members will include:
NON–FEDERAL PUBLIC MEMBERS. —Seven non–Federal public members, consisting of representatives of the following categories:
(i) Physicians and other medical providers with experience in diagnosing and treating tick-borne diseases.
(ii) Scientists or researchers with expertise.
(iii)Patients and their family members.
(iv) Nonprofit organizations that advocate for patients with respect to tick-borne diseases.
When selecting committees, FACA requires that the committees include those affected and that a balance of viewpoints be represented (GAO 2004). Moreover, the FACA handbook provides that the Membership Balance plan should identify the categories (e.g., individual expertise or represented interests) that potential members would fill. The patient community does not understand how the 2019 Working Group was selected, what roles the individual members fulfill or whose interests they represent. Nor do we understand why the current approach is vastly different from that of the 2017 Working Group. Why the sudden change?
Excluding the co-chairs (addressed below), the 2017 Working Group had three patient representatives. Since Bob Sabatino’s term ended in August, the 2019 Working Group now has one. The remaining patient slots have been filled with academic researchers. The 2017 Working Group also included an ILADS-affiliated clinician as well as one from the IDSA. The 2019 group only has the IDSA perspective represented, by Dr. Shapiro, but no ILADS clinician. Dr. Shapiro not only has substantial conflicts of interest, but also has extreme viewpoints and biases that are reflected in articles and many documented statements denigrating Lyme patients as a whole category.
**The Working Group does not adequately represent the interest of patients with chronic Lyme disease.**
The first Working Group included three patient representatives: Karen Forschner, Pat Smith, and Wendy Adams. In addition, the vice-chair was Kristen Honey, who also has lived experience with the disease. The new Working Group started with two patient representatives: Pat Smith and Bob Sabatino. However, Dr. Walker announced—without any apparent process integrity—that Sabatino would be replaced with a Rickettsia expert in August. (For reasons outlined below, the community does not view Soltysiak as a patient representative.).
Although the patient community supports the selection of Pat Smith as a patient representative, she alone cannot effectively represent the community on a committee in which she represents a minority. Single patients cannot shoulder the weight in deliberations or in votes.
**The Working Group’s expertise is over-weighted in Rickettsia and Academic Researchers.**
The Working Group is disproportionately made up of members with an expertise in Rickettsial illness, rather than Lyme disease. Dr. Walker, the Co-Chair, specializes in rickettsial illnesses, as do two alternative government members, Chien-Chung Chao, Ph.D, and Samuel S. Perdue, Ph.D. Dr. Walker announced at the June 4 meeting that Sabatino, the patient representative, would be replaced by Dr. Kevin Macaluso, whose expertise is Rickettsia. This results in a Working Group that is unduly focused on Rickettsia.
**The Working Group does not include a member of the International Lyme and Associated Diseases Society.**
Last term, Dr. Richard Horowitz represented community physicians who treat chronic Lyme disease. However, this term there are no physicians from ILADS. Given that the IDSA and ILADS hold sharply divergent viewpoints, the absence of the ILADS perspective is a critical flaw. When the Guidelines Clearinghouse was operational, the guidelines of ILADS (which were developed under GRADE and met the high standards of the National Academy of Medicine—previously the Institute of Medicine) were posted and the IDSA guidelines were removed because they were outdated. As noted above, almost all patients with chronic Lyme disease are treated by ILADS clinicians. Excluding an ILADS representative constitutes favoritism and ignores a vital perspective on the diagnosis and treatment of Lyme disease.
**Women are under-represented on the Working Group.**
There is a lack of balance in representation of women among the Working Group’s public members. In 2017, four of the Working Group’s seven public members were women. In 2019, only two public members are women. This should be viewed in the context that patients with chronic Lyme disease are significantly more likely to be female (Wormser, Shapiro, 2009). NIH Director Dr. Francis Collins has recently pointed out that women are too often under-represented on panels (Edwards 2019).
**The Selected Co-Chairs Raise Concerns.**
Co-Chair Leigh Ann Soltysiak has lived experience with Lyme disease. However, she is not known in the Lyme community and was not nominated by any trusted patient advocacy group as being qualified to represent patient interests. In addition, she works as a consultant for the pharmaceutical and medical device industry. It is unclear whose interests she represents. The last working group, she served on the vaccine subcommittee, which issued “unanimous” recommendations that the Lyme community opposed. Hence, the Lyme community does not believe that she represents the patient perspective. Whose interests was she selected to represent?
Co-Chair Walker specializes in rickettsial illnesses and is not known to have experience with Lyme disease. His first move as Co-Chair was to limit the panel’s focus on Lyme disease and shift it to rickettsia and other co-infections—essentially stating that there was no need to discuss Lyme disease anymore. Dr. Walker does not have the experience with Lyme disease essential to the Working Group.
His appointment as Co-Chair of this group is troubling for another reason as well. Dr. Walker also serves as Chair of the Congressionally Directed Medical Research Program (CDMRP), tick borne disease panel. The Working Group and the CDMRP are the only federal advisory committee and panel containing patient representation that focus on tick-borne diseases. Having Dr. Walker chair both bodies consolidates his power to disproportionately affect the national agenda and policymaking for Lyme disease.
**Conclusion.**
From the perspective of the patient community, there is no reason why the 2019 Working Group should lack process integrity and membership balance.
We ask that the membership of the committee be reconstituted as well as the process of selecting subcommittees so that they represent a balance of viewpoints, preserve the patient voice, and eliminate conflicts of interest. We also ask for greater transparency.  For example, the subcommittees were chosen some time ago and have met a number of times at the time of this submission.  Yet no public posting of membership has been made.
1. Dr. Shapiro should be removed from the Working Group because of his substantial conflicts of interests, his extremely anti-patient views, and the fact that a portion of his current salary is paid under an NIH/NCATS grant.
2. The Working Group balance should be improved by including more representation from patients with chronic Lyme disease and ILADS clinicians, so that it is more closely aligned with that of the 2017 Working Group. Specifically:
a. Two more patients should be selected for the Working Group. These should be patients with chronic Lyme disease (or caregivers) who have either been nominated by a trusted patient advocacy group or who are officers or directors of a patient advocacy group. Sabatino’s position should be filled by a Lyme disease patient representative. For example, the 2017 panel included three patient representatives who were officers or directors of patient advocacy groups. This panel has one.
b. A representative of ILADS with experience either treating patients or educating clinicians in the care of patients with chronic Lyme disease.
c. One Co-Chair should be a patient representative. Leigh Ann Soltysiak works in the pharmaceutical field. Although she has lived experience with Lyme disease, she is not recognized as a patient representative by the Lyme community and should either be removed or at least should not serve as Co-Chair. Her dual role (pharma vs patient)  provides opportunity for conflicts to arise or, at a minimum, for any role as a patient representative to be compromised.
d. Dr. David Walker should not chair two federal tick-borne disease bodies (the TBDWG and the DOD CDMRP). This consolidates too much power over policymaking in one individual, especially with the lack of balance of the other members on the Working Group. He should resign from one of these panels.
3. Each subcommittee of the TBDWG should include at least two patients/advocates and at least one ILADS clinician. They should be subject to the same balance as the Working Group and represent a diversity of viewpoints. The members should be publicly disclosed and confirmed by the Working Group in terms of balance.
4. Process integrity and transparency should be improved to ensure meaningful stakeholder engagement. More specifically,
a. Patients who have signed up for email notices should receive them far enough in advance of meetings to prepare verbal remarks or written submissions. There was no email notice of the June 4 Working Group meeting.
b. Membership of the Working Group should be publicly disclosed sufficiently in advance for patients to comment on the panel’s balance. Transparency about the member selection process, including who chooses the members, how nominations from patient advocacy groups were taken into consideration, other factors considered, and whose interest individual members represent should be disclosed.
Lorraine Johnson, JD, MBA
	CEO LymeDisease.org
Dorothy Leland
I write on behalf of LymeDisease.org and 57 other advocacy groups who represent Lyme patients throughout the United States, to express dismay at the newly appointed Tick-Borne Disease Working Group (TBDWG).
Specifically, we are concerned with
• The lack of process integrity and transparency in the selection of the members,
• The lack of balance of membership on the group,
• Conflicts of interests and extreme viewpoints of certain members,
The 2017 Working Group was adequately balanced in terms of viewpoints, and it reflected process integrity. Moreover, it was a highly effective, well-functioning group. It produced a report under a condensed timetable, with committee members and subcommittee members putting in extraordinary hours to meet deadlines.
However, there has been a profound shift in both process integrity and transparency for the 2019 Working Group. As a result, the voices of patients and their treating physicians have been suppressed, while the interests of academic researchers who do not focus on Lyme disease have been elevated. To the Lyme community, it appears that HHS has removed patient advocates and ILADS physicians and replaced them with Rickettsia experts and other academic researchers.
The make-up of the new group, the manner in which its members were selected, the presence of financial conflicts of interest, and the dramatically diminished role of the patients—who were responsible for passing the legislation that created the Working Group—raise red flags in the community regarding the panel’s legitimacy. This jeopardizes the credibility of its work and threatens to undo the progress made by the 2017 Working Group.
**Lack of Process Integrity and Transparency**
The best way to understand the sharp erosion of process integrity and transparency is to compare the 2017 Working Group process with that of the 2019 Working Group. The 2017 process included a call for public nominations for the group. LymeDisease.org submitted nominations, as did other Lyme disease advocacy organizations. HHS [redacted] Richard Henry was the point of contact for patients. He responded to many of our emails and effectively shepherded patient advocacy organizations through the necessary procedures.
In 2017, HHS announced panel members three weeks before the first meeting of the group. This allowed patient advocacy organizations to review the membership, assess whether it was balanced, and voice concerns. There were serious worries regarding one appointed member, Dr. Gary Wormser, a member of the Infectious Disease Society of America, who had substantial financial conflicts of interests. Over 10,000 patients signed a petition calling for his removal from the group. Before the TBDWG even convened, Dr. Wormser resigned and another IDSA member, Dr. Robert Smith, was appointed in his place.
The first public meeting of the 2017 Working Group focused heavily on the patient experience and evoked the legacy of HIV/AIDS. Richard Wolitski reviewed the charter for the Working Group and framed the task by saying, “Our job is to make sure this is a transparent and fair process...and find solutions.”
There was plenty of input from patient advocacy groups. Lorraine Johnson of LymeDisease.org and Gregg Skall of the National Capital Lyme Disease Association both addressed the panel. Many individuals gave personal testimony. The room was filled with patients. Subcommittees were selected, reviewed by the working group, and posted on the TBDWG website. All subcommittees included at least one patient representative.
The 2017 inaugural meeting embodied the spirit of “nothing about us without us.” In contrast, the 2019 working group’s inaugural meeting essentially kicked patients to the curb. The 2019 Working Group membership was officially announced by the HHS less than 24 hours before the first meeting. There were no advocate presentations, few public comments—and no remote participation allowed. Although it had been posted in the Federal Register, few patients even knew about the meeting. The patient community was not notified by email about the meeting as they had been in the past. As a result, the event was sparsely attended.
Although there was a public call for nominations and LymeDisease.org had offered the names of several patients who would be qualified to represent the Lyme community, there is no evidence that these suggestions were even considered. In fact, the Lyme community has no idea whether or how the role of balance of the Working Group was determined. Nor was the community given an opportunity to comment on panel balance. This is alarming, given the amount of controversy surrounding Lyme disease and the heightened need for transparency.
Although the 2019 Working Group members were not officially and publicly announced until the day before the meeting, the IDSA sent an email to its members and posted an announcement three weeks earlier that one of its members, Dr. Eugene Shapiro, had been selected for the group. When LymeDisease.org asked the HHS about this announcement, we were told by TBDWG staff that no members had yet been selected.
Dr. Shapiro is a lightning rod in the patient community, well known for his flagrant financial conflicts of interest, disparaging comments about Lyme sufferers, and for providing expert testimony against chronic Lyme patients and their treating physicians. LymeDisease.org launched a petition calling for his removal from the 2019 Working Group, which over 30,000 patients have signed. We advised Jim Berger, the Designated Federal Officer, about the petition and Dr. Shapiro’s conflicts of interests on May 21and have never received any response about it.
Dr. Shapiro was in fact listed as a member of the group by the HHS the night before the first meeting. Why did the TBDWG deny his appointment when asked, and claim that no members had been selected? What consideration was given to Dr. Shapiro’s conflicts of interest and extremely biased points of view? This reveals a staggering lack of transparency and process integrity, as well as profound disrespect for the concerns of the Lyme community.
At the June 4 meeting, Co-Chairman Walker appeared to continue this pattern. He suggested that the chairs of the various subcommittees would select subcommittee members without public disclosure, without any opportunity for stakeholder input, transparency, or consideration for balance under FACA. This would undermine the entire purpose of a balanced Working Group and be at odds with the processes used in the 2017 Working Group. Although we understand that subcommittees have been meeting in the last few weeks, as I write these comments on Sept. 4, there has been no announcement of subcommittee membership.
Did subcommittee chairs handpick their members with no oversight? Did they stack their committees with vested interests, excluding patients and their treating physicians? Who knows, because there has been no transparency whatsoever. If they did these things, it would fly in the face of the requirement for balanced membership and the impetus behind passing the legislation which created the Working Group. All work of the TBDWG is conducted by subcommittees, with the results flowing upward to the Working Group for consolidation into a single report. Without balance in the subcommittees, their reports to the Working Group may exclude vital viewpoints such as that of patients and their treating clinicians. This would also allow conflicts of interest or extreme bias to shape what information is provided to the Working Group. That’s a high risk in handpicked groups that have no oversight.
Dr. Walker also announced that Bob Sabatino, one of two patient advocates initially named to the 2019 panel, would be replaced with a Rickettsia expert at the end of August. Trading a patient representative for a Rickettsia expert compromises balanced representation. In addition, although the other subcommittee chairs could select their committee of interest, Dr. Walker merely announced that Sabatino would chair the tick subcommittee for his short tenure. What is the rationale for singling out a patient to head a subcommittee on ticks—an area where that patient does not have expertise? This appears to have been an attempt by Dr. Walker to ensure that the Rickettsia expert he had selected to replace Sabatino would chair a subcommittee of the new member’s choosing. This means that Sabatino did not chair a committee where patient subject matter expertise is most relevant. Rather, he merely served as a place holder for someone else. That isn’t patient representation—it’s tokenism.
Finally, Dr. Walker announced that as far as he was concerned, Lyme disease had already been covered by the previous Working Group and therefore there was no need to focus on this topic anymore. This is remarkable considering that Lyme disease is the culprit in 82% of tick-borne diseases cases in this country. Furthermore, the 2017 Working Group highlighted many areas for the future Working Group to address. It would be hard to imagine that a panel for HIV/AIDs would declare that it was “all done” before patient needs had been addressed.
We urge you reconsider these decisions you’ve made. Please investigate our concerns and reconstitute the membership of the committee and its subcommittees so that they represent a balance of viewpoints, preserve the patient voice, and eliminate conflicts of interest and extreme anti-patient bias.
**The following are co-signers to the written testimony of representatives of LymeDisease.org:**
Amber Allero, Regional Leader, PA Lyme Resource Network Altoona Area; Jill Auerbach, Chair, Hudson Valley Lyme Disease Association, NY; Lucy Barnes, Director, Lyme Disease Education & Support Groups of Maryland; Peter Baumann, President, Southern Tier Lyme Support, NY; Phyllis Bedford, Executive Director, LymeLight Foundation, CA; Melissa Bell, President, Florida Lyme Disease Association; Nancy Bourassa, President, Lyme 411, NH; Judy Campbell, President, Lyme Association of Greater Kansas City, Inc., MO; Cindy Casey, RN, Director, Charles E. Holman Morgellons Disease Foundation, TX; Alicia Cashman, Director, Madison Lyme Support Group, WI; Michele Cassetori, Regional Leader, PA Lyme Resource Network, NEPA Region; Alison Childs, Director, Lyme Stats, CA; Tammy Crawford, Executive Director, Focus On Lyme, AZ; Brandi Dean, Founder, The Dean Center for Tick Borne Illness at Spaulding and Ride Out Lyme, Inc., MA; Anne Desjardins, Regional Leader, PA Lyme Resource Network Berks County, PA; Jeffrey Dugas, Director, Brookfield/Wolfeboro NH support group; Luke Dunham, Regional Leader, PA Lyme Resource Network, Tioga County; Doug Fearn, President, Lyme Disease Association of Southeastern Pennsylvania; Christina Fisk, President, Lyme Action Network, NY; Bruce Fries, President, Patient Centered Care Advocacy Group, DC; Karen Gaudian, Chair, LymeConnection.org, CT; Linda Giampa, Executive Director, Bay Area Lyme Foundation, CA; Holiday Goodreau, Executive Director, LivLyme Foundation, CO; Lee Gordon, Regional Leader, PA Lyme Resource Network, Montco Region; Cathy Gumlock, Regional Leader, PA Lyme Resource Network, Lehigh Valley; Karen Hansen, Regional Leader, PA Lyme Resource Network, Bucks County; Eric Huck, Regional Leader, PA Lyme Resource Network, Harrisburg Area; Jody Hudson, Founder, Alex Hudson Lyme Foundation, CA; Paula Jackson Jones, President and Co-Founder, Midcoast Lyme Disease Support & Education, ME; Marie Kearney, ANP, Founder & Coordinator, Southern Arizona Lyme Disease Association; Michelle Louie, President, Arizona Lyme Disease Association; Ellen Lubarsky, Leader, New York City Lyme Disease Support Group; Ali Marchese Perch, Regional Leader, PA Lyme Resource Network & Lymie Moms United; Julie Merolla, MSW, LICSW, Director, LDA Rhode Island Chapter; William Moore, Regional Leader, PA Lyme Resource Network, Pittsburgh Region; Scott Morris, Director, Long Island Lyme Association, NY; Connie Moschell, Chair, Northeast Ohio Lyme Foundation; Charlotte Moss, Regional Leader, PA Lyme Resource Network, Columbia County; Elizabeth Naugle, Co-Moderator, TXLyme; Mike Nickel, Moderator, Wisconsin Lyme Support, WI; Carrie Perry, President & Founder, Sam’s Spoons Foundation for Lyme Support & Education, PA; Stacey Plourde Cash, Regional Leader, PA Lyme Resource Network, Fulton County; Jean Ann Redman, Regional Leader, PA Lyme Resource Network, Bradford County; Linda Reilly, Director, Mid-Shore Lyme Disease Association, Inc., MD; Rita Rhoads, Regional Leader, PA Lyme Resource Network, Lancaster County; Karen Ruberto, Regional Leader, PA Lyme Resource Network, Butler County; Maggie Schaefer, RN, BSN, Director, Litchfield County Lyme Network, CT; Colleen Schake, Founder, Lyme Disease Coalition, Inc., PA; Sharon Shaffer, Regional Leader, PA Lyme Resource Network, Adams County; Renée Sharpe, President, Chambersburg Lyme Alliance, PA; Pat Smalley, Director, Mid-Hudson Lyme Disease Support Group, NY; Richard H. Smith, Vice President, Lyme Disease Association, Inc., NJ; Sheila Statlender, Chair, The Massachusetts Lyme Legislative Task Force; Diane Sunday, Regional Leader, PA Lyme Resource Network, York County; Amy Tiehel, Regional Leader, PA Lyme Resource Network, Delco Region; Julia Wagner, President, PA Lyme Resource Network; Monica White, President/Cofounder, Colorado Tick-Borne Disease Awareness Association.
Dorothy Leland
	Vice-president of LymeDisease.org
Phyllis Mervine
I submit these comments on behalf of LymeDisease.org and 57 other Lyme patient advocacy organizations from across the United States. We are deeply concerned about the financial conflicts of interest and extreme viewpoints of one member of the panel—Dr. Eugene Shapiro.
**More than 30,000 people have signed a petition calling for his removal from the Working Group.**(https://www.change.org/p/tick-borne-disease-working-group-keep-eugene-shapiro-off-the-federal-tbdwg) The Lyme community does not object to having an IDSA representative on this panel. However, we take serious exception to Dr. Shapiro, who has substantial financial conflicts of interest and an extreme anti-patient bias. His conflicts of interest and bias are well known and wide-ranging. They are exhibited in his publications, public statements, legal testimony against patients and their treating physicians, and consulting arrangements. He was a named defendant in the Connecticut Attorney General Antitrust Investigation regarding the 2006 IDSA Lyme guidelines, which he co-authored. He is currently a named defendant in a civil RICO lawsuit alleging that he, among others, conspired with insurance companies to deny patients with Lyme disease access to care (Torrey et al vs IDSA et al).
Dr. Shapiro’s most recent conflict of interest disclosure on a JAMA opinion piece reveals that he consults with Lyme vaccine manufacturer Valneva (which just announced successful results from FDA Phase 2 trials), is paid by insurers to testify against Lyme patients, receives fees for testifying against the physicians who treat patients with chronic Lyme disease, and serves as a director on the American Lyme Disease Foundation. The ALDF represents the interests of IDSA researchers and disingenuously holds itself out as representing patient interests. [Its website touts “the best private organization-based site that can be recommended to patients for education on Lyme disease is that of the American Lyme Disease Foundation.” Patients view this organization as waging war against people with Lyme disease. In a recent interview, ALDF President Phil Baker referred to patients with chronic Lyme disease as a “cult.”]).
Dr. Shapiro also has an annual NIH grant (Clinical and Translational Science Award UL1 TR001863) of $1.2 million, which pays a portion of his salary. His position on the Working Group, while he has received funding from the sponsoring agency, suggests further politicization of the Working Group selection and process.
His publications are hostile in tone and disdainful of patient concerns. For example, a recent article entitled “False and Misleading Information About Lyme Disease,” disparages organizations that hold views that diverge from his and dismisses these views as “false equivalency” or fake.
His public statements show a strong and derisive anti-patient bias. For example, a Stanford grand rounds presentation took special aim at Lyme patients, making fun of and eliciting laughs at their expense.
“So clearly, these patients were sick. They had problems. It's just that antibiotic deficiency was not one of them. [laughter]”
“Q. (Audience): How do you convince people who are committed to the diagnosis of Lyme disease, that Lyme disease is not the cause of their non-specific symptoms, especially after they have the support of their own physician, confirming this diagnosis? A. (Shapiro): I have a whip! [laughter]”
A recent article in the Boston Globe says this:
“Shapiro, the Yale epidemiologist, says we have a long history of protean illnesses that can absorb the anxieties of patients.... ‘If your nose falls off,’ Shapiro says, ‘you can find out that Lyme disease makes your nose fall off.’”
In summary, we believe that Dr. Shapiro should be removed from the Working Group because of his flagrant financial conflicts of interests, his zealously anti-patient views, and the fact that a portion of his current salary is paid under an NIH/NCATS grant. **Dr. Shapiro actively works to foment a culture of disrespect for Lyme patients, and his seat on this panel is viewed by patients as discrediting the work of this group**. It’s also seen as a disparagement of Lyme patients who pressed to have the legislation passed that created the Tick-borne Diseases Working Group and whose interests are supposed to be the driving force behind the group’s work.
The 2017 Working Group avoided strong conflicts of interest and anti-patient bias. There’s no reason for the 2019 Working Group can’t meet that standard as well. **Accordingly, we urge the removal of Dr. Shapiro from the Working Group.**
The following are co-signers to the written testimony of representatives of LymeDisease.org:
Amber Allero, Regional Leader, PA Lyme Resource Network Altoona Area; Jill Auerbach, Chair, Hudson Valley Lyme Disease Association, NY; Lucy Barnes, Director, Lyme Disease Education & Support Groups of Maryland; Peter Baumann, President, Southern Tier Lyme Support, NY; Phyllis Bedford, Executive Director, LymeLight Foundation, CA; Melissa Bell, President, Florida Lyme Disease Association; Nancy Bourassa, President, Lyme 411, NH; Judy Campbell, President, Lyme Association of Greater Kansas City, Inc., MO; Cindy Casey, RN, Director, Charles E. Holman Morgellons Disease Foundation, TX; Alicia Cashman, Director, Madison Lyme Support Group, WI; Michele Cassetori, Regional Leader, PA Lyme Resource Network, NEPA Region; Alison Childs, Director, Lyme Stats, CA; Tammy Crawford, Executive Director, Focus On Lyme, AZ; Brandi Dean, Founder, The Dean Center for Tick Borne Illness at Spaulding and Ride Out Lyme, Inc., MA; Anne Desjardins, Regional Leader, PA Lyme Resource Network Berks County, PA; Jeffrey Dugas, Director, Brookfield/Wolfeboro NH support group; Luke Dunham, Regional Leader, PA Lyme Resource Network, Tioga County; Doug Fearn, President, Lyme Disease Association of Southeastern Pennsylvania; Christina Fisk, President, Lyme Action Network, NY; Bruce Fries, President, Patient Centered Care Advocacy Group, DC; Karen Gaudian, Chair, LymeConnection.org, CT; Linda Giampa, Executive Director, Bay Area Lyme Foundation, CA; Holiday Goodreau, Executive Director, LivLyme Foundation, CO; Lee Gordon, Regional Leader, PA Lyme Resource Network, Montco Region; Cathy Gumlock, Regional Leader, PA Lyme Resource Network, Lehigh Valley; Karen Hansen, Regional Leader, PA Lyme Resource Network, Bucks County; Eric Huck, Regional Leader, PA Lyme Resource Network, Harrisburg Area; Jody Hudson, Founder, Alex Hudson Lyme Foundation, CA; Paula Jackson Jones, President and Co-Founder, Midcoast Lyme Disease Support & Education, ME; Marie Kearney, ANP, Founder & Coordinator, Southern Arizona Lyme Disease Association; Michelle Louie, President, Arizona Lyme Disease Association; Ellen Lubarsky, Leader, New York City Lyme Disease Support Group; Ali Marchese Perch, Regional Leader, PA Lyme Resource Network & Lymie Moms United; Julie Merolla, MSW, LICSW, Director, LDA Rhode Island Chapter; William Moore, Regional Leader, PA Lyme Resource Network, Pittsburgh Region; Scott Morris, Director, Long Island Lyme Association, NY; Connie Moschell, Chair, Northeast Ohio Lyme Foundation; Charlotte Moss, Regional Leader, PA Lyme Resource Network, Columbia County; Elizabeth Naugle, Co-Moderator, TXLyme; Mike Nickel, Moderator, Wisconsin Lyme Support, WI; Carrie Perry, President & Founder, Sam’s Spoons Foundation for Lyme Support & Education, PA; Stacey Plourde Cash, Regional Leader, PA Lyme Resource Network, Fulton County; Jean Ann Redman, Regional Leader, PA Lyme Resource Network, Bradford County; Linda Reilly, Director, Mid-Shore Lyme Disease Association, Inc., MD; Rita Rhoads, Regional Leader, PA Lyme Resource Network, Lancaster County; Karen Ruberto, Regional Leader, PA Lyme Resource Network, Butler County; Maggie Schaefer, RN, BSN, Director, Litchfield County Lyme Network, CT; Colleen Schake, Founder, Lyme Disease Coalition, Inc., PA; Sharon Shaffer, Regional Leader, PA Lyme Resource Network, Adams County; Renée Sharpe, President, Chambersburg Lyme Alliance, PA; Pat Smalley, Director, Mid-Hudson Lyme Disease Support Group, NY; Richard H. Smith, Vice President, Lyme Disease Association, Inc., NJ; Sheila Statlender, Chair, The Massachusetts Lyme Legislative Task Force; Diane Sunday, Regional Leader, PA Lyme Resource Network, York County; Amy Tiehel, Regional Leader, PA Lyme Resource Network, Delco Region; Julia Wagner, President, PA Lyme Resource Network; Monica White, President/Cofounder, Colorado Tick-Borne Disease Awareness Association.
Phyllis Mervine
	Founder and President of LymeDisease.org
Charlotte Meyer
I am 56 years old and a “Foodie”. I’m from the Eastern Shore of Maryland – specifically Oxford, MD.
13 months ago I awoke at midnight covered in a full-body rash with burning palms and soles of my feet. One month later I was diagnosed with Alpha Gal Syndrome. I know I was bitten by a Lone Star Tick because I saved the tick. It was somewhat unusual looking from the ticks I usually see – such as the black legged (deer) tick or the American Dog (Wood) tick. I’ve seen a lot of ticks in my life because I grew up on a farm on the eastern shore, live on a farm now, always have dogs, and married a beekeeper who is also a hunter – we see plenty of ticks.
When my allergist diagnosed me after a lab test that showed I was positive for Alpha Gal, he said, “You are now officially to avoid all mammal meat. Your labs indicate that you have a high allergic potential for beef and pork. You should be able to consume dairy.” He added that some of his patients were able to east cured meat such as ham, but others could not. He finished by telling me he was diagnosing 20 cases of Alpha Gal a week. Holy cow!
I requested more information from him about the allergy, its history and what research was taking place. I asked him about support groups in the area or places where I could go to read about Alpha Gal. He said, “I don’t know about any support groups in the area and I don’t believe there is much information out there, to be honest with you.” I was stunned.
Within my first year with Alpha Gal I’ve found many friends and acquaintances that have this red meat allergy. One friend has had it for 30 years. Only one friend is in full remission. As for me, I’ve spent the year reading, talking to people, and testing what I could and could not eat. The more I read and the more I tested, the more everything changed. My allergic reactions are changing and becoming much more severe. I had my first episode of anaphylaxis this past July and that was frightening. My husband was completely overwhelmed that I have a life-threatening allergy. In the beginning, I could have the occasional one piece of bacon and some months later I absolutely could not tolerate it – proven by my first experience with anaphylaxis. Last weekend I had my first dizzy spell from sudden blood pressure drop when I ate pancakes at a local restaurant. They had been cross-contaminated with either bacon or sausage fat from being cooked on the same griddle. Now I experience trepidation about eating out because I know my safety is not just about what I choose to eat – it is about how my food is handled in restaurant kitchens. I have no idea if I can trust that meals ordered out are safe for me to consume. Welcome to my new and profound anxiety. I struggle to keep it at just anxiety and not full-blown paranoia.
The implications of this unstable pathway are mind boggling to me. Do food handlers in restaurants and other food preparation industries know that cross-contamination can put lives at considerable risk? I have a sense that it will take years to bring about food labeling requirements and years to implement and push for compliance. **I urge the working group to consider public awareness and educational campaigns that will raise the platform of Alpha Gal allergies within food industries.**
I’m aware that numbers are important and we don’t have them: How many people are living with Alpha Gal? How many cases of Anaphylaxis are Alpha Gal related? How many medical and dental professionals do not understand Alpha Gal and that in their not knowing – they put patients at risk for anaphylaxis and other severe reactions? **I urge the working group to update their medical forms and statistical in-gatherings to include diagnoses of Alpha Gal Syndrome and Alpha Gal related illnesses. I also urge the working group to target educational campaigns about the impacts of medicines, vaccines and medical procedures that use, contain or are exposed to mammal products for all healthcare professionals and Emergency Medical Team personnel.** These groups are unable to uphold their vows to “Do No Harm” if THEY DON’T KNOW THE HARM THEY CAN DO.
I’m aware there are important questions to be answered and so many unknowns: What causes such a wide range and severity of allergic reactions? Why do some people go into remission, or partial remission and others do not? How do other factors like exercise and alcohol contribute or change someone’s reactions? There is no road map for Alpha Gal sufferers like me and let me tell you – WE ARE SUFFERING! Our lives have changed. My life changed – and if feels like it is changing more and more every day – and including more uncertainty. **I urge the Working Group to push for funding for more research to address these and other important questions pertaining to Alpha Gal.** I want to know that what is happening to me, and thousands of others, matters.
Thank you.
Charlotte Meyer
Deborah Olsen
I’ll keep this letter brief and to the point.
Some people including myself have Alpha Gal and also have inhalant / fume allergies from mammal being cooked and becoming airborne. I was wondering if anyone has thought of including a member from the Board of Education due to the fact that we have children who are affected by mammalian particulates becoming airborne in school cafeterias and causing allergic reactions that can lead to anaphylaxis?
I would also like to know about the Legal ramifications of people who do not follow strict food avoidance protocols for children with alpha gal. Example, child care providers, separated parents, schools etc ... Are there laws in affect to make sure children are safe while in the care of others ? Not only protecting them from eating mammalian products, but also keeping them safely from tick laden areas?
What is the protocol for all schools for Tick Removal for a child? I have been told that school nurses will not remove ticks from children, and this is unacceptable to me. Not only can a child get Tickborne diseases but in the case of alpha gal it can reactivate our symptoms and make us feel horrible with hives, inflammation and histamine overload as well as anaphylaxis.
Thanks for your time.
Deborah Olsen
Mary Beth Pfeiffer
**Medicine and government have failed to help us battle Lyme disease**by Mary Beth Pfeiffer
https://www.nj.com/opinion/2019/08/medicine-and-government-have-failed-to-help-us-battle-lyme-disease.html
In the same week recently, a New York state woman died from a paralyzing virus and an Ontario, Canada, boy suffered meningitis, both from the bite of a tick. Thousands more nationally and hundreds in New Jersey were infected in a medical crisis in our midst.
We live in an era in which going outdoors is risky. But this unfolding epidemic – of which Lyme disease is but a significant part -- has been made worse by failures of government and medicine.
Don’t fault doctors, who have been told only the rules of Lyme disease, not the significant exceptions. Blame the medical society that has crafted, promoted and fiercely defended the guidelines governing Lyme care, the Infectious Diseases Society of America. Blame the U.S. Centers for Disease Control and Prevention, which has endorsed an unhealthy status quo that governs treatment worldwide.
We have been told: Watch out for ticks. They can infect.
We have not been told: Tests fail. Treatments may not work. Doctors know little about treating advanced Lyme cases, malaria-like babesiosis or Powassan virus, a tick-borne illness that killed a Sussex County man in June.
I thought I knew Lyme disease in 2012 when I began research as an investigative reporter the Lyme-rife Hudson Valley of New York. What I knew were the myths of Lyme disease, which infected more than 400,000 Americans in 2017.
**Myth #1: The test works.**
Compare pregnancy to Lyme disease. The first is a rapid yes-no diagnosis revolutionized by in-home kits. For Lyme disease, we use a 25-year-old, two-part test that is unreliable and difficult to interpret. First, you need a sufficient load of generic antibodies. Then, you must register “bands” on a test strip for specific antibodies. Say you get four of a required five bands. You are declared Lyme-negative. A woman is never a little bit pregnant.
Scientists reviewed the universe of Lyme test studies — 78 in all — and concluded, remarkably, there wasn’t enough evidence “to make inferences about the value of the tests.” Another analysis found the tests predicted Lyme disease just 54 percent of the time.
**Myth #2: Lyme is over-diagnosed.**
About three dozen scientific papers have warned doctors not to needlessly prescribe antibiotics because of the potential for false Lyme positives. But wait: If the tests can be trusted, why do we have this problem at all? And what about patients who actually have the disease but are failed by a bad test?
This is a disease in which a missed diagnosis can be life changing. Mothers have told me of months of schooling and childhood lost to Lyme disease, which is most prevalent in boys 5 to 9 years old.
While antibiotics should be used judiciously, the line that has been drawn on Lyme disease has made doctors fearful of treating early or well.
**Myth #3: But you get the rash.**
Optimistically, the skin rash that signals Lyme infection without a test shows up in 60 to 80 percent of cases. But that means up to 170,000 patients did not get the rash in 2017 (using estimates that say there are 10 cases for every one reported).
And the rash looks like a classic “bull’s-eye” in only a tenth of cases -- so variable that patients may be told it’s a spider bite or cellulitis, especially in a milieu that warns of over-diagnosis.
**Myth #4: 10 to 28 days of antibiotics kills the bug.**
Yes, antibiotics cure -- if you’re lucky enough to clear diagnostic hurdles and get early treatment. But even in that rarified group, up to a fifth of patients remain symptomatic for a year -- and 1 in 20 after 15 years. People who are treated later fare worse, with studies implicating Lyme disease with brain inflammation, nerve and joint damage, and poor quality of life.
For two decades, a battle over why some patients stay sick – are they chronically infected or not? – has overshadowed a growing and expensive epidemic.
The IDSA, which is being sued in federal court over Lyme disease care and has proposed updated but inadequate guidelines, says the test and antibiotics work. The other side, including university scientists supported by nonprofit groups, has published findings showing that the Lyme bug outwits medicine’s best tools, leaving behind adaptive, shape-shifting “persister” cells. These residual Lyme cells may explain a lot – but only with a major infusion of government-funded research.
“Neither side has enough data to assure they are right,” Garth Ehrlich, a renowned Drexel University scientist, told me. But “orthodoxy has just killed research in Lyme disease.” There’s little urgency to solve a problem medicine won’t acknowledge.
Today, when a month of antibiotics fails and a patient goes back to the doctor, they are told:
“I don’t know how to help.”
“I followed the guidelines.”
“You may be sick, but not with Lyme disease.”
Patients need and deserve better answers than that.
Mary Beth Pfeiffer
Doreen Svardal
Hello. I was diagnosed (accidentally) with Alpha Gal in March of 2016. I had been ill since July of 2015 and was diagnosed completely by accident. An allergist had done a "skin prick" allergy test and I came back allergic to beef and dairy (which doesn't always happen.) After doing my own research, I requested to be tested for Alpha Gal. The allergist said, "Well, I'll test you for it, but you probably don't have it since you can eat pork." I came back positive at 1.62.
What is ironic about all of this is that I live in Southwest Missouri. It is an Alpha Gal "hotbed" for lack of a better word. In fact, during the 2009 test that Dr. Commins and Dr. Platts-Mills used to create the test FOR Alpha Gal, 5 of the 24 subjects were submitted from [redacted] at the Farell Duncan Allergy Clinic in Springfield. Sadly, [redacted] has since passed away, and much of the knowledge (not to mention research) in the Southwest Missouri area has also died with his passing.
In the last 4 years, I have had to go to the emergency room approximately 8 times. Despite the fact that AGS is "all over the news," I have withstood comments from medical staff such as;
During a bi-phasic reaction after Epi-pen use from a nurse this spring: "You're allergic to mammal? I don't know if that's even a THING, but obviously something is happening so I'll get you back there."
"What do you mean, you're allergic to mammal?"
"You're allergic to what? From what? How?"
For a while there, it was like every single ER visit was like that. I was literally dying, trying to live, trying to breathe and then on top of that----when my BP is soaring and my Oxygen is tanking....I have to educate and explain myself. How? How to do it when your brain is spinning? Why must I....at that moment.....to get treatment....have to go through what I have, what it's from and how to fix it? Good God. When you cannot even breathe, you cannot explain. I have a friend (as I'm a single person) that Does The Hospital with me. She has to take time out of her day to come and explain and advocate for me. So now my syndrome messes with her life, too.
I have been treated like excrement in the emergency rooms, as though I'm an addict seeking some sort of form of painkiller, as opposed to Benedryl and Solu-Medrol. I have had to learn on my own what is safe, because until recently, there was no physical way for them to put "Alpha Gal Allergy" in their allergy section in the [redacted] Hospital System computer. Consequently, I have been given medications with gelatin, mammal by-products, etc. I fear for the day that I may go into anaphylaxis, be unresponsive and completely unable to explain my situation. Thus, I wear an allergy bracelet, allergy necklace and carry meds and epi pens WITH a medical protocol listed in the event that I cannot speak. I am fortunate enough to have a pharmacist that understands, but because he has to call each company about any "unknown" potential ingredients, it takes days to get medications that should just take hours to get.
I am concerned with medical treatment. I'm concerned that doctors and nurses do not have the knowledge or sensitivity to deal with someone who is in the middle of anaphylaxis (many of us---myself included--do not present with the traditional "hives.") I have difficulty breathing and begin walking into things, with no coordination. Then I black out.
I am concerned in food labeling. No one is accountable for verifying what mammals "natural flavors" come from. Dairy is easier, but there is no way to know if beef broth is in chicken soup, because that doesn't have to currently be disclosed and someone with AGS could die from it. For all we know, they already have---but since AGS anaphylaxis is not tracked, we'll not know until it is.
I am concerned that I have had to fly to North Carolina to see Dr. Commins just to be understood and not treated like crap when I live in a "hotbed" of AGS. I now travel 2.5 hours to see [redacted] in Bentonville, Arkansas. She's worth every part of that trip. But why must I travel so far? Why is this not being studied more and most importantly, why aren't doctors getting the information?
I am also concerned with the fact that no one is tracking this. In Arkansas, veterinarians track it for our pets. So pets get better treatment then we do? Why is no one tracking this? Why does it keep getting shoved from department to department? I suspect because it is all a costly, costly nest of worms and we desperately need someone to advocate for us.
Doreen Svardal
Trisha Tipton
Hello! I would like to share some of the ways that alpha gal syndrome has affected my life. I have had alpha gal syndrome now for at least 11 years. I was misdiagnosed for several years even though I was seeing an allergist who said he knew about alpha gal but never had me tested for it. It took my reactions getting worse and worse and then finally leading to anaphylaxis for me to do more research myself and discover that I had alpha gal. When I took this to my allergist I told him what test to do and sure enough that’s what was causing my reactions. One of the things that scares me the most about alpha gal is the fact that the medical community is still not aware enough of it to diagnose us correctly. This really scares me if it were to come to a life-threatening situation and emergency medical care. I feel that I would have to have a family member present to keep me safe from being harmed by potential alpha gal containing medications from doing me further harm than I’m already in. This is terrifying to me and makes me feel very helpless in any sort of emergency situation especially ones that might occur when I am alone.
Another part of having alpha gal syndrome that is very alarming to me is food labeling or lack thereof. Many times we have to navigate through very hard to understand labels and ingredients that we have never heard of and try to figure out when they contain a mammal by-product. The fact that natural flavor can essentially be anything coming from a plant or animal limits us to any foods that have natural flavor without a long call to the manufacturer and a potential wait to find out what is actually in the product. The public deserves to be informed about what is actually in their food. But especially those that have life-threatening allergies at least deserve to be able to know what the food ingredients are derived from so that we can make an educated decision as a consumer of what is best for us and our families.
Going to a restaurant is even harder because the majority of the time there are so many hidden ingredients in foods and so little education about alpha gal syndrome that it can be extremely stressful to even attempt to eat out anywhere with our families.
Alpha gal syndrome has greatly altered my life. I no longer have much of a social life at all. I am very stressed to leave my home where I have my safe foods that I have already investigated myself and deemed to be safe. I no longer enjoy traveling because eating out can be extremely stressful. Some of the things that could make life easier for those of us with alpha gal syndrome: to simply educate the public so that restaurants have heard of alpha gal much like a peanut allergy. That way they can have some sort of a protocol for dealing with our allergy. Also informing all medical personnel of what alpha gal syndrome is and provide a list of safe medications that can be used in the event of an emergency would be life saving in our case. And last but not least plainly and easily labeling all foods and listing whether they contain mammal derived ingredients such as the ones that list peanuts or dairy on a label would help immensely in picking out safe foods for us. All of these things would greatly improve the quality of life for those with alpha gal syndrome. I appreciate your willingness to listen and hear us and more importantly your willingness to help us.
Thank you, Trisha Tipton
Andrew Vandiver
I’m 38 and live in western Kentucky.. I have been dealing with Alpha Gal food allergies for almost a decade .. we need to get to the bottom of the this , this allergy is growing and spreading across the nation .. there is no educational awareness about this ..
The food I have to buy because I can’t eat red meat, dairy or gelatin really limits me .. I’m having to to shop for almost specific items , which are usually more expensive than ordinary food items .
Please ... please let us, the people with this allergy help.
Sincerely,
Andrew Vandiver
Elizabeth Vari
Foremost, I appreciate the work the group continues to do, and I seize this opportunity to write. My story begs an open mind in light of no clinical proof or current testing to confirm eradication of Lyme disease. The disabling permitted with dismissive complacency is evident.
The details of 24 years are concisely written, mindful of limitations, although a detailed version may be available upon request.
I acquired a vector bite in June 1995. At the time I was an Active Reservist, training in Willow Grove, PA. In 1995 the sensors were not heightened as today. I attest, I was among the naive. The time delay in subtle sensory manifestation became more easily understood - retrospectively. I was released from further reserve training to follow up with a Neurologist for a neuropathy noted.
Sparing the lengthy work up completed by a Neurologist and Rheumatologist, all results were within normal limits. I, however, continued to decline.
Following these work ups, an antibiotic happened to be prescribed for an infection. Not only had my infection resolved, my muscular skeletal pain was greatly diminished.&
In seeking Lyme specialist [redacted], I was diagnosed with Lyme and co infections. The diagnosis was made ten months after the vector bite. Ten to twelve weeks of oral antibiotics returned my fluid gait and ability to climb stairs. Six months following, I relapsed. Due to insurance change, I sought medical care from [redacted]. His work is recognized and referenced by the TBDWG. [redacted] ordered IV antibiotics for greater than the minimum at the time. A recovery was noted with fluid return of gait.
Our family relocated twice since these treatments, to other than endemic areas of Virginia. In seeking medical care in these communities, my Lyme concerns lacked proper appraisal. Since the delivery of our last child in 2006, I have been challenged neurologically. Insidiously, I was declining.
In 2012 I learned of Camp Lejeune Water Contamination, as I served at Camp Lejeune 1985 - 1987. A solvent profile reveals a threshold of toxic chemicals, holding implications for the immune and central nervous system.
My remarks are shared after reaching out to many of the best in their field of study. While water contamination presents a troubled understanding of paralleling symptoms, my symptoms are the same experienced post vector bite, rather than those that had occurred during contamination exposure at Camp Lejeune.
I have endured the quarter century of physicians ....  I remain aghast of many excusing themselves from wanting to treat or understand, or clinically follow. The lack of caring to follow medically, is an oppressive reveal. No excuse would suffice for declining to offer study/care to a veteran enduring the walk.
Establishing a clinical approach is vitally reasonable. I am not suggesting a willy-nilly approach with antibiotic. However, refuting benefit, held by physicians ill attuned, has already voiced great disabling risks. A clinical approach, as with other inexact disease, may prove to quell the decades of debate.
Elizabeth Vari
Lynchburg, VA.
Hypothyroidism with concurrent Lyme disease. www.ncbi.nlm.nih.gov/pubmed/7642407
Filley, CM: Toxic leukoencephalopathy. www.ncbi.nlm.nih.gov/pubmed/11496854
Review Epidemiology of organic solvents and connective tissue. www.ncbi.nlm.nih.gov/pmc/articles/PMC129987
Camp Lejeune: Past Water Contamination - Public Health. www.publichealth.va.gov/exposures/camp-lejeune

                    
  


Content created by Office of HIV/AIDS and Infectious Disease Policy Content last reviewed September 11, 2019Back to top
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