TBDWG July 24, 2018 - Written Public Comment
All Tick-Borne Disease Working Group (TBDWG) meetings dedicate time for public comment. The TBDWG invited written public comment on issues related to the Working Group's charge. Written comments are submitted via email to the TBDWG mailbox. Below are the written comments submitted by individuals for the July 2018 meeting.
Anonymous Commenter 1
I was diagnosed with Alpha gal February 2018 after suffering for nearly a year with symptoms. I Was Bitten July 2016 on the back of my knee. Because I had such a strong reaction in my leg and continued itching for months after I went to the doctor and requested a tick panel. Everything came back negative. I had even kept the tick but once hearing the test were negative threw it away. The leg continued itch.
I begin having more symptoms in 2017. Nearly a year after the bite. Random rashes would appear throughout my body. I itched so often I went to bed with a back scratcher. I was nauseous everyday all day. As the symptoms grew worse the rash grew up my body. And my lips began to swell. Throughout the process I had extreme allergies but I brushed it off as just a bad allergy season.
I have abstained from meat since the dia gnosis with the exception of chicken or fish. The first few months was horrible and I lived in a state of anxiety. I felt that I couldn't eat out for fear of contamination. I carried an EpiPen with me wherever I went. My doctor told me to try to continue Dairy but if I have more than a tiny amount I had a reaction.
It should be noted that the tick was attached less than an hour. I felt it on my way home from work but was driving and couldn't remove it until home.
Some of the doctors in my area would not even test for alpha-gal and said it didn't exist. There needs to be much much more education. Most people I meet have never heard of it. Or if they have they don't understand it fully. It's often described as a red meat allergy which is untrue.
Anonymous Commenter 2
Tick-Borne Disease Working Group:
I want to give you one quick example of how the tick-borne ‘disease’ Alpha-Gal affects normal people and how the system is not equipped to deal with the situation.
I recently had a cold that led to a sinus infection resulting in a splitting headache. I used Tela-doc for the first time and did the standard intake forms including allergy information. I told them about my Alpha-Gal. After talking to the doctor, she sent a Rx to Walmart for me. My husband picked up the Rx and I happily took two doses that day. The next day my headache had subsided enough for me to realize that the Rx was in the form of gel-caps!
- Yes, I failed to notice and protect myself, but I was in a compromised condition at the moment.
- The doctor’s system failed me too. When I reviewed the online records the Alpha-Gal was noted- as an environmental allergy. It is SO MUCH MORE than that!! I believe that the doctor probably did not pay attention because it was not labeled as a DRUG allergy. I attempted to add it as a drug allergy. I could not. The only way you can do that is to NAME A SPECIFIC DRUG.
- The pharmacy system failed me too. I wasn’t there so I don’t know exactly what occurred, but they had a previous record of my Alpha-gal allergy. (when I told them and asked them to check the drug I was getting on that occasion the pharmacist had rather flippantly said it wasn’t a gel cap so it was OK. When I got home I researched it and determined that it had magnesium stearate in it so it very likely was NOT OK, but luckily, I am not hyper-sensitive so I did not react. But the pharmacists lack of ‘knowledge’ and lack of ‘concern’ were quite obvious from his comment)
Even if a quick cure cannot be found to Alpha-Gal quick steps can be taken to make the situation much better.
- Legislation needs to be passed to force changes to databases so that generic ingredient allergies get JUST AS MUCH PROTECTION as an individual medicine allergy. Why should someone who is allergic to penicillin be more protected than someone allergic to red meat by products?
- Legislation needs to be passed to force that ALL ingredients be listed. (No listing natural flavorings, etc.- because beef bouillon IS natural, and will cause a reaction) This legislation needs to cover primarily medicine and food but really everything. For instance, candles, plastic containers (which may leach), as well as any coating on the plastics to lubricate them during processing or to reduce static, or for ‘slip’. If there is more than one source- i.e., magnesium stearate the mandate needs to include specifying the source.
All legislators, and any companies that object need to be reminded that PEOPLES LIVES ARE AT STAKE. Alpha-gal suffers deserve to have the information they need to protect themselves. And unfortunately, that means that every-single-solitary-ingredient needs to be listed to help ensure that absolutely no mammalian by-products are present in anything we eat, drink, breath, sit on, wear, bathe with, wash our clothes with, or very importantly need for any medical procedure!
King George, VA
Anonymous Commenter 3
I was diagnosed with Alpha Gal almost 2 years ago after months of not knowing what was causing the symptoms I was having. I am extremely concerned with the lack of education with the medical field. Please please compile some means of updating the medical field with the knowledge they need for this allergy. I am shocked at the lack of concern doctors and nurses have when it comes to this life threatening allergy. One thing that seems to be overlooked are the terms that are used for ingredients that consist of beef and pork and their byproducts. They seem to not know simple terms such as "bovine" means cow!! Below is the event that describes my experience yesterday at my local family physicians office:
Yesterday, July 10, 2019, I had a "Wellness Visit" (per medicare) with my family Dr. During the visit I was encouraged to take the Pneumonia Vaccine. I asked if it was safe with Alpha Gal Allergy. I asked specifically "Does this vaccine contain ANY beef or pork ingredients?". My Dr. gave the okay and I then asked not 1 but 2 nurses this same question. I was told it was perfectly safe and contained no beef or pork. When I began with the itching tongue I decided to google the Pneumonia Vaccines online. That's where I found it had a "bovine" ingredient. I called back to the Drs. office and the nurse responded, "Well it has such a small amount of bovine it should not effect you." What?!!!! A microscopic amount is too much for Alpha Gal allergy. I ended up having a full blown reaction that caused me to spend the evening in the local emergency room. Thankfully I was able to be treated before my airway closed. Please, please help Alpha Gal patients and urge the medical community to take the time to learn about this. Your help in this matter could save lives.
Anonymous Commenter 4
I have Alpha Gal. In 2010 I was bitten by a tick. Shortly after being bitten, I began experiencing the following reactions:
- Severe stomach cramping; diarrhea; red/itching palms and soles of feet, hives; coughing; hoarseness; shortness of breath; brain fog; nausea; vomiting; swelling; dizziness; low blood pressure; loss of consciousness; runny nose; hair loss
I have been to many physicians, specialists, and emergency rooms over the last 8 years. I always felt the reactions were due to the tick bite, and I was sure to mention this to the physicians during each visit. Most would tell me they didn’t think a tick bite was causing my problems, because they don’t cause the types of reactions I was having. I was usually sent home with a prescription that almost always made me sick, (looking back now, it probably contained mammal) and a diagnosis of one, or more of the following:
- IBS; vasovagal syncope’ hypotension; hypertension; fatigue; inner ear; vision; anxiety; vitamin deficiency; stress, etc.
In November 2016, I broke out in large welts, and had shortness of breath. I went to see an allergist, who also didn’t appear very interested in hearing about my tick bite, or think it had anything to do with my reactions. He did suggest testing for allergies to the following:
- Soy; wheat; corn; peanuts; pecans; trees; grasses; pork; beef; dairy; egg white
I tested positive for all the above, but exceptionally high for beef and pork. I was told to eliminate all the above from my diet. I was surprised about the beef/pork allergy. I went home and researched beef/pork allergies on the internet. I noticed Alpha Gal kept popping up. I called the allergist the next day and asked the nurse to be tested for Alpha Gal. A few days later I received a call from the nurse, who told me my A.G. test was positive. When I asked her why the doctor didn’t suggest testing for Alpha Gal when I tested positive for beef/pork, she said they really didn’t know much about Alpha Gal, and didn’t think about it. I even had to question if I needed to carry an Epi-pen. I have since found another allergist who is familiar with Alpha Gal, Dr. Tina Merritt. Her office is 3 ½ hours away, but it’s worth the drive to have a doctor who knows how to properly treat alpha gal, and doesn’t look at you like you have 3 heads when you discuss your reactions.
After being diagnosed with Alpha Gal, I knew my life was going to change, I didn’t realize how drastically! My husband, and I have always loved being outdoors, working in the yard, traveling, camping, hiking, kayaking, fishing etc. Now, I cannot safely do any of those things for fear of another tick bite that could cause my reactions to escalate. I can also no longer enjoy BBQs with family and friends, eating out at restaurants due to the danger of cross contamination/fumes. Fumes has been a real problem for me not only at home, but at work too, so much so, that I had to reduce my hours to just enough to keep major medical insurance. I work in a long term care facility, where meals are prepared 3 times a day. The fumes from cooking mammal, causes hoarseness, coughing, shortness of breath, drop in blood pressure, dizziness. I have to go outdoors for fresh air during mealtimes, or stay in my office with the door closed. After a reaction to fumes, I become severely fatigued.
Alpha Gal affects every part of my daily life! Grocery shopping is a BATTLE! I spend hours in the grocery stores reading labels. I must read every label on any product I am thinking about purchasing to be sure it does not contain mammal. There are words like enriched, enriched with what? Fortified, fortified with what? Flavoring, flavored with what? Natural flavoring? What is the natural flavoring? I have to call the manufacturer and give them my name, my phone number, address, email address, the UPC codes, expiration dates, etc. I am then put on hold while they check the ingredients, they return to the phone only to tell me that they will have to contact the supplier and will call me back in 3 business days. Most of the time, I have to call them back and told they still do not have the information on the product. I have had to wait 5 months for information about the word, “FLAVORING” on a package of Roasted Turkey! Because mammal and mammal by-products are in so many products, foods, medications, cosmetics, etc., ingredients need to be clearly listed on labels! Our lives depend on it!
Anonymous Commenter 5
To whom it may concern,
I was diagnosed with alpha gal about two years ago. I know I went at least 3 years without being diagnosed. I also have a child that has been diagnosed with alpha gal.
I think the most important things that need addressed is better educating doctors – for faster diagnosis, and for better patient treatment. Educating society as a whole, for better diagnosis and better public awareness on how to prevent it and to know the symptoms to help get diagnosed. Most importantly though – is medication. Making sure pharmaceutical companies know exactly what is in their medications, because apparently they do not. Labels on foods and medications would be nice to.
I had the same doctor for 18 years and he was amazing, but he actually sent me to a shrink instead of properly diagnosing me, as he thought my anxiety was terrible since I was saying all the time I cannot breathe and get dizzy and light headed. I also told him one medication he prescribed me for heart burn was making me sicker (he said not possible, well it is when you are allergic to gelatin). I also had an episode where one vagina lip swelled gigantic from an allergic reaction and I was told it must be creams I used (I had used the creams because of the swelling). I was treated like I was a crazy, and sometimes I felt like I was. I have never felt that way again since being diagnosed. I have since moved out of state and have new doctors but none are knowledgeable on alpha gal.
One morning I had a cheese burger and had an anaphylaxis reaction. I had to be taken to the ER where the ER doctor kept questioning that I had never had a reaction before. He didn’t believe me. He said the reaction was way too severe to have not had a reaction before. I almost died that day. My blood pressure was 58/32. My eyes were swollen shut, my hands and feet were swollen huge. I could not breathe and hand hives over 90 percent of my body and itched worse than I ever have in my life.
I went to my new family physician who referred me to an allergist. For the next 2 weeks I had terrible life threatening reactions almost every day, as I never even had a clue it was my supper every night that was making me so sick.
The allergist diagnosed me properly, but did not give me one piece of information on what to avoid. I am allergic to beef, pork, lamb, mammal, gelatin, dairy – but she could not give me one pamphlet. Up to that point I had never had an allergy in my life, nor knew anyone with severe allergies. I knew that milk, cheese, sour cream, butter are all dairy – but other than that I did not know how to read labels -completely unaware that whey is dairy, etc. Would have never guessed that pork fat is in some turkey lunch meats for flavor, that mammal is in so many things. I felt like the allergist threw me to the wolves. Like go live (or die) and learn.
If I would not have come across the alpha gal support group on facebook, I don’t even know if I would still be alive.
I stopped taking medications right away. I went in to talk to the pharmacist and asked if my high blood pressure medications contained any mammal or gelatin. He said he didn’t know. That the inserts had been thrown away but he would try to find out online. He was unable to find information and told me if it had any it would probably be so small it would not affect me. Finally I learned from the facebook group that my prescription was okay and do take it.
Recently my vitamin D was low. I was prescribed something. I had the pharmacist help me. Described all my allergies, and I told him magnesium stearate can be plant or mammal = he said he thought it was all plant – HE’S A PHARMACIST – HE SHOULD KNOW THIS. He said he would call the company and call me. He said he called the company and stated they said it was plant. First day I took it I had a severe reaction. So either he didn’t call or whoever he was on the phone with didn’t do their job.
I am scared to get sick as I do not want to have to be prescribed any medications.
I started getting hep b vaccinations before I was diagnosed, as my former son in law had hep b and lived next door. The doctor would not give me the third shot in the series until I called the pharmaceutical company and figured out if it was okay to take it or not. When I called the person wanted to know why I want to know if it contains mammal or gelatin and treats me like some weirdo – when I am just trying to get my vaccination. At first they told me that I needed to discuss it with my doctor. This kind of run around is common for us with Alpha gal. They eventually gave me the information. I was still petrified to the get the vaccination, hoping nobody messed up.
The government certainly needs to make changes with all prescription and over the counter medications. We with alpha gal need to know if we can take it, pharmacists need to know what is in medications, and pharmaceutical companies need to be able to know if mammal is in the ingredients.
Eating now is very expensive. To be able to eat something more than turkey, chicken and cheap fish we purchase duck, emu, ostrich, shrimp, crab. There should be a tax deduction or something of that sort.
Three months before my alpha gal diagnosis. I was very ill. I had received many tick bites cleaning up our new land. I went to the doctor and was treated for Lyme disease. I was not tested for anything, as she stated that she was sure it was a tick-borne illness and that doxycycline works on most all tick borne illnesses in Missouri. After a week I did feel much better. I do not know if I have Lyme, and if I did get it = I hope the prescription worked.
I am glad there is a group to listen to our stories and I hope that the information I conveyed to you is helpful in writing your report. Doctors need more education and something has to be done for medications. Our health care with alpha gal is terrible because of these two areas and it will cost someone their life, I am sure it has already.
Anonymous Commenter 6
My wife and my son both have alpha gal. Since they have been diagnosed their medical treatment has been crazy. Dentist appointments, doctor appointments, allergy appointments and every trip to the pharmacy has been anything but desirable.
Since they have been diagnosed it has really changed our lives. It did even before diagnosis when they both were getting sick. The government needs to make more public awareness, do more research and testing, and make mammal a familiar allergen on food, cosmetics, and medication labels.
I am no longer able to just pick up prescriptions or over the counter medications for them. Every time I have, I have bought something they cannot use. Pharmacy employees and pharmacists are not usually very helpful or informative.
I am not able to pick up food from the grocery store either. Some foods I know now are a safe item in our house, but there are too many things they are allergic too and it is not clearly identified on the labels, which makes it hard for me to do any of the shopping.
Again, I would like to see the government make more public awareness, do more research and testing, and make mammal a familiar allergen on food, cosmetics, and medication labels.
I am a tax payer and a registered voter.
Anonymous Commenter 7
I am a 19 year old college student, tax payer, and registered voter with alpha gal from a tick bite. I was diagnosed November of 2016. A month after my mother was diagnosed with AG.
Its kind of an uphill battle, but I am learning better ways to cope. When I was in high school, they did not understand at first. I still feel like they never really did understand. I have never had any allergies before this so it was a new learning experience for me and my family. The lunch ladies at school would just let me go pick out what I wanted in the kitchen because I think they were scared to feed me because they were uneducated on the situation.
But last year, I did hit a rocky stage where I did do a month in jail and 4 months in prison treatment in Missouri. I made my allergies aware on multiple occasions in both facilities. They treated it nowhere near as serious as they should have. I did in fact get sick on a few occasions. They also made me work in the kitchen at the treatment center even though they had my medical records and documentation. They acted as though breathing in something I am allergic to would not affect me = which is not the case. In the jail I had to choose sometimes between either going hungry or risking my life as they would not clearly tell me what the food was. They acted like it wasn’t a real allergy. When I was transferred from the jail to the prison they did not send my epi-pens – they threw them away.
So, the meals that did contain beef or pork, I would ask for a vegetarian tray and was served cold beans. So many meals I was served cold beans because of my allergy. Imagine being allergic to so many different food ingredients but not being able to control or find out what your food is being made with. I had no way of asking every ingredient.
I am not in any way trying to get the correction system in trouble. I am trying to illustrate how it is a real problem. How someone could be in prison who is not diagnosed yet and the problems they would face on eating until diagnosis.
Also in prison, I received a flu shot. It was my choice. I got so sick. It was obviously not alpha gal friendly. I did not know. It is imperative that medications and vaccinations are clearly labeled. I am lucky I am still young and healthy and have not had to have any medications yet. I see what my mom has gone through and read what problems other people have had.
I use to give blood every chance I would get. I have stopped now, because I cannot get a clear answer on if I can give alpha gal to someone or not. I get the impression, nobody really knows. So, I won’t take the chance on infecting anyone.
When I was diagnosed by the allergist, she gave me zero information on alpha gal. I have had to learn everything from my mom, and from a facebook group.
In a nutshell there needs to be more public awareness, especially to help those in institutions. More research – I stopped giving blood. There needs to be more education for doctors, allergen labels and overall alpha gal just needs taking more seriously – which starts with how the government handles it.
Anonymous Commenter 8
I was bitten by three ticks on May 3, 2018, after walking through a stand of tall grass in my neighborhood (A lone star tick, a deer tick, and a dark tick I'm not able to identify).
On May 22, I became sick with what felt like a terrible case of strep throat. It would get bad every weekend, and then I would feel terrible through the first half of the week, and start to feel like I was getting over it by the end of the week. I missed no work, but I felt terrible with headaches, sore throat, and an overwhelming feeling of listlessness.
I am so lucky to have found out what I have so quickly. I felt that the sickness wasn't "normal," and thought it might be connected to the tick bites, so I looked up the symptoms of tick related illnesses. There isn't much awareness or literature about the alpha-gal allergy. Once I saw that the alpha-gal allergy causes a delayed allergic reaction, my symptoms started to make sense. I eat mostly homemade vegetable dishes during the week, then go out with friends on the weekend and eat beef (burgers, steaks). This is why I was feeling terrible every weekend, then starting to come around again by the end of each week.
I'm certain I have the alpha-gal allergy. By altering my diet to exclude mammal meat and products including dairy, I've regained my health. If I accidentally get into food with a very small amount of mammal, I develop a sore throat several hours later. If I eat a burger, I feel downright sick about 3-4 hours later, then tired. The next morning I have a headache and feel worn out - as if I ran too far the day before. I drank 16 oz. of milk to see what would happen, when I wasn't sure what my problem was. I had the most severe reaction I've had to anything, and won't be repeating the experiment (intestinal distress, sneezing, coughing, shortness of breath).
I went to my PCP 8 days ago, to get the alpha-gal blood test. I would like to know what my numbers are. My nurse practitioner had never heard of the alpha-gal allergy, and asked me what it was. I told her. I then described my symptoms. She said it sounded like that's what I have, and advised that I avoid foods that make me sick. I described the blood test, and asked for it. My PCP doesn't have a contract with a lab that can perform the test, so I'm looking for another doctor.
There don't seem to be many health care professionals who have even heard of this allergy.
Shopping for food, and eating have become very difficult. There doesn't seem to be any labeling for mammal allergies at all. Foods that seem like they would be safe aren't. The item listed as "natural flavors" in ingredient lists can be derived from mammal products. Foods that don't include any mammal products can be made using mammal products as part of the process. (I had a reaction to turkey sausages with safe ingredients on the ingredients list. I later found out they're prepared in a natural cow casing). I'm learning what's edible now, but I lost weight in the beginning because I had trouble figuring out what was safe to eat.
There is a lot of conflicting and bad information available about the alpha-gal allergy on the internet. There are some claims about different ways of curing it, but I doubt everything that isn't attached to a study. Hopefully I can find a knowledgeable doctor who has real information.
Anonymous Commenter 9
I have friends that have alpha gal. A new tick-borne illness that not enough people know about. They face many challenges eating the right thing so that they don’t have an anaphylactic reaction. I fear for a lot of people who might get this Illness. With the tick population growing and more and more diseases coming from them, they need to make more vaccines; something to stop this from getting any further. We have to be fearful of even going out camping or walking through the woods; something has to be done. I hope that you take this very seriously; their lives have changed, they can’t go places, they can’t do things, and most of all can’t be treated for a lot of things because of their allergy to medicines.
Anonymous Commenter 10
This is my AGS story. Much needs to be done for Alpha-gal research and treatment.
My partner, Pam and I enjoyed a quiet 4th of July at home. She fixed us a great all-American cheeseburger and we watched the DC fireworks on TV.
Around 1:00 AM, I woke Pam and told her I was having some issue because I was covered with welts. Around 3:00 AM I again woke her and asked her to take me to the ER, because I was having trouble catching my breath.
She asked me to put my arm around her as we started down the hall toward the back door. I took a few steps and collapsed, losing consciousness in anaphylactic shock. Fortunately she had the presence of mind to quickly call 911. When the ambulance arrived my blood pressure was 72/34.
Apparently I had received a Lone Star tick bite a couple of weeks prior. Even though I told the doctors I had received multiple tick bites in mid-May, no tests were done. The multiple doctors which I was treated by seemed reluctant to order the test and appeared to doubt that I could have a tick borne illness. We had to demand that the Alpha-gal allergy test be done. I was finally was tested on July 11th.
My test results confirmed that I have a severe alpha -gal allergy. Class 5, 96.9 was the reading indicating I am extremely sensitive. My life is totally changed.
Growing up in Arkansas, I have received hundreds of tick bites throughout my life with no issues. I am a 64 year old male.
It is hard to believe this is happening now. Research needs to be done. The public needs to be educated and schooled on what to do in the event a friend or family member has a reaction. Doctors need to be more proactive and order tests when a patient tells them they have had a tick bite. Insurance companies need to understand it is cheaper to pay for tick borne testing than to pay for ER visits or death claims.
Thank you for your consideration.
Anonymous Commenter 11
Alpha Gal Syndrome: A Child’s Perspective
Alpha-Gal Syndrome is a tick-borne condition that has changed the life of our family. We have struggled for 4 years and 3 months with AGS and the challenges it presents. It was not until August 2017 that we found a physician who was willing to hear out our concerns and test for a meat allergy. I would like to share our story in a question and answer format as this is the easiest way for my son, 8 years old with AGS, to tell HIS story.
- How long have you had symptoms of your allergy? 4 years
- What are the symptoms you get from a reaction? I break out in hives from eating pork and mammal meat
- What do you do to treat your reactions? I have to not eat pork and meat. If I do break out, we have to stab me with my epi pen.
- How do you feel about the doctors who have treated your Alpha-Gal syndrome? One doctor was annoying and obnoxious because she did not believe my mom about my allergy. She did not know much either. Dr. Tuohy was really nice and knew what to do about my allergy. I like her a lot. She gave me a popsicle.
- What are some activities that you once enjoyed but no longer can? I can’t eat meatballs or a Big Mac meal from McDonald’s. I can’t eat anything that I like no more.
- Why are you homeschooled? Cause my meat allergy.
- How does Alpha-Gal Syndrome affect your life each day? It changes my life a lot because I can’t have meat anymore.
- Tell me how you feel about Alpha-Gal: I think it’s stupid. I wish I was allergic to broccoli instead because I hate that. I feel scared sometimes because I don’t want to die from it. I have a whole life with my mom, dad, step dad, and baby sister. I want to keep living.
In April of 2014, my son was bit by a tick at 4 years old. After removing the tick from his side, he began to develop a whelp over the area. A few days passed, and the whelp kept growing until it covered an 8-inch area. Yes, this whelp was huge. As you can imagine, we grew very concerned. The concern mostly stemmed from the fear of Lyme disease. We visited our family physician and they tested for Lyme Disease. The whelp never had a bullseye area but because of the severity, the physician decided to treat him for Lyme with antibiotics even though the test results came back negative. We gave him antibiotics for ten days and thought all was well.
About a month after his tick bite and treatment, our son began breaking out into hives on his belly and back for no apparent reason. We’d give him Benadryl and the hives would go away quickly. As this began happening more frequently and worse in severity, we began wondering what was going on. We visited the primary care physician and he was just as baffled as us. Visit after visit, we could not find the answer to what was causing these reactions. On a visit to a shop we frequented, we talked with a man named Luke about our son’s reactions. He asked if he had any recent tick bites. I showed him the picture of the whelped bite from a few months before and he began to tell us all about Alpha-Gal Syndrome. We were in complete awe and a little horrified at the mere thought that our child may possibly have something so severe. We followed up with our family care physician and of course, he had never heard of AGS but did refer us to an allergy specialist in the area.
During our visit with the allergy specialist, I mentioned AGS and requested that our son be tested. I was pretty much laughed at and made to feel a little insane for “thinking” our son could be allergic to meat. They did conduct an allergy skin test, but not including any meat just the generics: grass, pollen, bees, mice, peanuts, etc. We left with absolutely no answers and a lot more frustration.
Until August of 2017, we were in and out of the ER with reactions that seemed to be a mystery. No doctor we saw had an idea of what was going on. We began feeling overwhelmed and hopeless. In August of 2017, we went to the ER 3 times with each reaction covering our sons body---arms, legs, chest, back, and face. His lips, eyes, and ears began swelling. He was administered epinephrine while at these visits. The moment of realizing things were getting much was overwhelming; the moment of fearing for how much worse it would get before we found an answer was one of the worst moments in my life. As a mom, we are supposed to care for and protect our children but here I was HELPLESS.
We had recently switched our son to a new primary care physician, Dr. Anne Marie Tuohy. We reached out to her in hopes that someone, just one person would hear our plea for help and for once, someone actually listened to my “crazy” thought that our son was allergic to beef and pork. She ran the blood work and at the end of August, we FINALLY received answers. Our son tested highly allergic to beef and pork. Even though our doctor didn’t know much about AGS, she trusted me as a mother, she made me feel supported, and together we found answers.
Since Dr. Tuohy wasn’t very familiar with AGS, she didn’t know to run the Alpha Gal panel tests, but we knew enough about AGS to avoid all mammal meats. We have seen a stomach specialist who did a complete panel test which definitely confirmed AGS. Even after these tests, we were referred to Dr. Irani, an allergist. Dr. Irani insisted, even after reading his lab reports, that he had an auto immune disorder and not AGS. Of course, she ran those tests and they came back negative. Finally, she called to apologize and agreed with 2 other physicians that our son did in fact have AGS. Since August of 2017, our son has stopped eating all mammal meat and been completely reaction FREE! Praise God!
Our journey with AGS has been frustrating, frightening, and felt mostly helpless. The bottom line is, we are failing at educating the people we entrust the most with our healthcare. Awareness for AGS has finally started taking off but it’s not where it should be. We need to educate medical professionals and citizens in general because the truth is, any person can be the next victim of AGS. We honestly live in fear each and every day because there isn’t enough research for AGS. We know enough to avoid mammal meats and mammal byproducts, but that’s it. The fear of our son being exposed to a trigger is at times overwhelming. Constantly fearing cross contact or merely touching something where mammal meat has sat is a heavy weight to carry. In fact, we choose to homeschool our 8-year-old son because it’s the only way we feel we can fully protect him from being exposed to allergens. In a school setting, you may have a peanut allergy table in the cafeteria but where does someone with a mammal meat allergy feel safe to sit? Our lives have changed because of AGS and all we can do is pray that our son eventually recovers from this dangerous allergy, so he can live a life without fear. We want answers, we deserve answers, and we deserve medical providers who are educated on AGS!
Anonymous Commenter 12
Dear TBDWG members and Subcommittee members,
Three months ago I requested data from the State of Colorado, Colorado Department of Public Health & Environment (CDPHE), regarding tick species, tick-borne pathogens and human disease surveillance in Colorado. I was aware that a passive surveillance effort had been initiated by the previous State medical entomologist to collect ticks from Veterinarians in 2014. The project was initiated in 2014 and it appears to have lost momentum in 2017. There have been no active surveillance efforts made by the CDPHE for tick species nor pathogens.
I just recently received the data from CDPHE. Several of the ticks collected from pets (dogs) were identified as "non-human biters" with no genus nor species identified. In a previous transcript I had read from a presentation of the data, species of Ixodes were mentioned, yet the data does not identify any Ixodes in the table. No pathogen testing was indicated for any of the collections. We know from previous research in Colorado (authored by CDC) and California that ticks within Colorado are competent vectors for a number of human pathogens that are not nationally notifiable.
In addition to the the tick data. I requested human disease surveillance data as well as criteria for reporting to the CDC. This is the information that I received when I requested the information from the Zoonoses Epidemiologist from CDPHE.
" there are some limitations. Babesiosis, anaplasmosis, ehrlichiosis and Borrelia miyamotoi infections are not reportable in Colorado so we do not have records of Coloradans who test positive for those infections. We also do not save information on positive lab reports that do not meet case definition. We are also limited in what information we're allowed to provide based on health information confidentiality policies".
I was also informed that:
"When the department receives a positive laboratory report from a Clinical Laboratory Improvement Amendments (CLIA) certified facility that meets the laboratory evidence criteria described in the case definition, the report is shared with local public health agencies to investigate for clinical criteria. The department only investigates and reports conditions that are approved and listed by the Colorado Board of Health under Code of Colorado Regulations: Epidemic and Communicable Disease Control (6 CCR 1009-1).Colorado uses case definitions available at: https://wwwn.cdc.gov/nndss/"
The surveillance process is greatly impeded for states that are considered low incidence or non-endemic.
- Example: Elderly rancher in Gunnison, Colorado, was just diagnosed with Babesiois after suffering relapsing fever like symptoms. This case will not be reported to CDC because Babesiosis is not currently a nationally notifiable disease. And even though Babesiosis has been identified in both Colorado wildlife and competent tick vectors within Colorado (Burkot et al. 2001), this disease will not be considered a risk to human health because these tick vectors are widely considered as non-human biters, though incidence of both pets and people being bitten have been reported.
- Example: Local Longmont, Colorado woman that lives on a ranch presents with bull's eye rash in 2016, objective symptoms and tests positive for Lyme with western Blot by a CLIA certified lab, but has no travel history. Her case is reported to the State by her treating physician, but no case is reported to CDC.
These examples highlight the importance of using additional available data from laboratories or insurance records to truly assess the incidence of tick-borne disease in humans throughout the US, but especially in regions where surveillance has not adequately occurred. It also highlights the need for improved surveillance and more research of ticks in states that are considered low incidence or non-endemic for many Tick-Borne Diseases.
The restraints of our surveillance system which relies heavily on poor current surveillance data and very little research of potential western species tick vectors actually impedes true surveillance of diseases (especially in what are considered low incidence or no incidence states) from actually occurring.
It is imperative that all Tick-Borne Diseases become nationally notifiable or there will be no requirement nor method for States (especially perceived low incidence states) to track and report cases regardless of where disease may originate from. It is also imperative that reporting criteria is standardized so that regions where disease is considered low incidence or non-endemic do not continue to be dismissed for potential human health risks based on assumption alone.
Thank you TBDWG for your consideration of these very important points in the limitations and failures of our current surveillance system as they relate to regions of low incidence or non-endemic status.
I guess where I should start is when I was a little girl. When I was around seven years old my family found a couple of ticks on my head. Apparently they were pretty large. I think this happened in Texas. I ended up with hives all over my body. My dad was a doctor so he took care of it. Over the years I kept having difficulty with breathing. My mom and dad would have arguments over whether or not I had asthma. My dad would say “It just doesn’t fit. It’s got to be something else.” I kept having reactions throughout my whole childhood that caused trouble with breathing. My dad developed the whole protocol for when I would have an episode that included using adrenaline to help me breathe. I moved out when I was 18 and was diagnosed with asthma and allergies by a Doctor who saw me for 15 minutes. For 30 years I took the medications for asthma and the only thing that ever helped was the adrenaline. I was in the emergency room 3 or more times a year. I only went to the emergency room when it got really bad. The doctors said I had so much damage to my lungs I had lost 20% of my lung capacity.
In 2001 I developed hashimotos hypothyroidism. I was on the medication for three years and my symptoms got worse and worse. I ended up being allergic to everything I ate. My mouth felt like I was eating a pin cushion. Finally an endocrinologist looked at my numbers and said this makes no sense. He ran some tests and told me I was reactive to bovine. I went to my doctor and I told her what the endocrinologist had said. She started testing me and diagnosed me with Lyme and an anaphylactic reaction to bovine. I stopped taking the medicine for my thyroid, stopped eating red meat, treated the Lyme and noticed an immediate improvement in my reactions. I had to find a new way of treating hashimotos hypothyroidism. The medications all have animal products at its base. Over time I became reactive to all meat products.
The biggest struggle I have now is knowing when I’m exposed to meat. In 2008 I bought a bottle of juice. It was not a usual thing for me to drink but I didn’t think anything of it. It sent me to the emergency room because it had been filtered through gelatin. The amount of gelatin in the juice is below the level required for labeling, but it is sufficient to kill me and others like me who have alpha gal.
Over the years I have become more and more sensitive to meat products. At this point I’m reactive to the vapors in the air from cooking meat.
My body responses pretty quick, my lips swell up, my throat closes up and I can’t breathe. It is the scariest thing in the world not being able to breathe. I’ve spent the last 30 years practicing breathing exercises to help me breathe. I truly believe that my breathing exercises are the only reason I’m alive. I have been told I was close to death too many times due to Alpha-gal. It wasn’t until that last couple of the years that I truly removed all animal products from my environment and food. That includes everything from toothpaste, shampoo, soap, mulch and cleaning products. I had no idea how it was affecting me until it was completely removed.
I am truly on the road to recovery now, but the path that I took to get here has been extremely difficult. There is so much more I could tell you but I think the thing that you really need to know is: I was undiagnosed with Alpha-gal for many years. I would imagine there are many more out there are who are undiagnosed. My quality of life improved dramatically once I knew what to look for.
Please help us by supporting the unfortunate citizens who have been bitten by a tick and became a member of the Alpha-gal community. Include alpha gal in your working group and help make our lives safer with better labeling laws. Our lives depend on you.
With hope from Oregon,
Sixteen years ago I made four trips to the ER in full anaphylaxis due to Undiagnosed Alpha Gal. They always happen in the middle of the night for me.
The first one I woke up with swelling in my ear and it progressed to hives all over. Due to uninformed and denial of seriousness by family members I have had to drive myself to the hospital several times. One time I knew I didn’t have time to get to the hospital in my in -laws town. My mother- in -law was awake but told me to calm down and didn’t offer to take me. I said, “You don’t understand, If I don’t get liquid Benadryl in 10 min my throat swells shut.” I didn’t have time to get to the hospital and so I drove to Walmart by then in full hives. I opened a box Of Benadryl in the pharmacy dept at 2 am and chugged 50 mg. When I got in line to pay people parted like the Red Sea and told me to pay so I could go on to the hospital.(where the nurse scolded me for driving on so much Benadryl).
Thankfully after that nonsense my allergist diagnosed me and I never go anywhere without Children’s liquid Benadryl and my Epi Pen.
It has completely changed my life. I now have dermatagraphia urticaria as well - super itchy sensitive skin that welts up in hives with the slightest scratch.
I was afraid to eat out for fear of cross contamination, fear of potlucks, family reunions (I bring my own food), my own best friend forgot and put bacon grease in my green beans. I once broke out due to trace of pork on my husband’s mustache after a kiss (of death). I have gotten sick after using an Epi-pen in car on way to ER with my children in the backseat-luckily husband drove that time. I will spare you the details of so many more attacks.
I’m telling you my whole life and eating habits are changed as I’ve had to learn how to avoid all mammal meats in the south, with my husband a BBQ master. I also can’t have any part or whole milk dairy products, gelatin, many supplements, medications, etc.
Also, there’s the worry of the long term effects of the disease, how does it affect our iron, potassium, white matter, mast cell problems in older age.
Speaking of old age, can you imagine how scary it is to think that no nursing home could honestly follow this regimen? I don’t have to be a vegetarian, I can have poultry and fish, but I would have to select vegetarian meal everywhere as I do on group trips, airplanes, etc, so as to not take ANY chances. I wear a bracelet with my precautions, but this will not keep me from dying unnecessarily should people not check my bracelet, or med chart for allergies before offering something to me I might not be allowed. I just hope I keep my mind so I can defend my mouth.
Please, please, please.....we need more public awareness, better restaurant chefs, servers who have heard of it and care, but especially better research and doctors who don’t question our reactions. I have friends with even worse symptoms from Lyme and I just know it’s time we not let the tiny tick get away with Murder.
If you have further questions concerning my story please contact me below,
Thank you for your consideration,
Sincerely suffering from this illness,
Learning to Live with Alpha-Gal Syndrome
I was officially diagnosed with Alpha-Gal Syndrome nearly one year ago, although it is becoming apparent to me now that I have most likely been dealing with it for at least a couple of years, if not more. My initial testing revealed that I was in the “extremely high” range, and although my most recent tests showed much improved numbers, my symptoms are much worse than they were a year ago. When I was diagnosed, I simply reacted to ingesting beef and pork. Today, I react to all mammal meat, gelatin, magnesium stearate, carageenan, dairy, and even the fumes of mammal meat being cooked. Being exposed to any of these can cause anything from mild digestive discomfort and hives, to life-threatening anaphylactic shock.
Living with any allergy is difficult, but living with one that is life-threatening can be scary. Alpha-Gal is even more terrifying, because what I was fine consuming yesterday can easily turn into something that will cause me a severe reaction a week later. I have found refuge, support, and answers to these problems and more within patient support groups online. Thankfully, other patients and their experiences help me to navigate the perils of this life-threatening, and life-altering condition.
I truly cannot say the same for the medical community.
Learning to manage this condition has been especially challenging, since so few medical professionals truly understand the scope of the disease. There is also far too much misinformation on AGS, even within the medical community. For instance, I was told by one allergist that gelatin is not an issue. I know from experience that gelatin most certainly IS an issue, as I have had several reactions to it, both in foods and in medications. This, by the way, came from an allergist that is currently treating over 75 patients with AGS, and his practice group treats over 300 AGS patients locally. He also argues that magnesium stearate and carageenan, both common culprits for reactions, have not been shown be tied to AGS. I did provide him with documentation on why, in fact, these common food/medication ingredients can cause us problems, and then did request and receive a referral to an allergist more familiar with the disease.
Another frightening experience that is worth sharing details of happened to me last fall when I had major surgery, a hip replacement. In advance of surgery, I spoke in detail with the surgeon about my concerns regarding AGS, so that I could identify any potential risks. Normally following a hip replacement, patients are administered Heparin, a porcine-derived anticoagulant, to prevent deep vein thrombosis post-surgically. He informed me that he would instead administer Lovenox, a different drug that would give the same benefits, but that was safe for me. I did my due diligence to research the drug, and found that it also was derived from porcine (pig) tissue. The surgeon argued with me, and even refused to take the drug order off of my surgical plan, until I gave him a printout of the Prescribing Information of the medication, printed directly from the manufacturer’s website.
These two encounters with medical professionals highlight the urgency of the task before your group. As patients, we rely on the knowledge and expertise of our doctors, surgeons, pharmacists, dentists, etc. And yet there is no real source of validated information that they have to go to for verified information. Obviously, there is still a LOT to learn about this disease, so it is also my belief that fast-tracking research on AGS, and its many implications, is of paramount importance.
One of the reasons I believe research regarding this unusual allergy is of grave importance is due to the ways it differs from “normal” allergic reactions and anaphylaxis. Not only do we experience delayed reactions of up to 4-6 hours, but there are other factors that I (and other patients I have talked with) have that are alarming, and in my understanding, atypical for allergic reactions. The most distressing symptom to me personally is severe tachycardia (elevated heart rate) and blood pressure spikes, which makes me nervous to use my Epi-Pen as treatment. In an anaphylactic episode in which I had to call 911 (before my diagnosis, so before I was prescribed an Epi-Pen), the EMTs told me they were unable to administer epinephrine, due to how high my heart rate was. This is an unusual anaphylactic symptom that a number of patients with AGS have reported. So now when I have a reaction, I must weigh the risk of causing a life-threatening stroke by using my Epi-Pen, or risk dying of anaphylaxis before help arrives.
Another area of grave concern for anyone trying to navigate the perils of this condition is labeling for food and medications. I rely heavily on the patient support forums for information regarding food and medication ingredients and additives, since none of that information has been made available to me from my doctors, besides the basics of “avoid all things mammal”. For example, something as benign-sounding as “natural flavor” is most often made from mammal ingredients, and is included in a huge amount of processed and packaged foods. Although I have been able to reduce my exposure by eliminating as much processed food as possible, there are many people who are unable to do so (because they don’t know about the risks, or can’t afford less processed foods), and risk harmful exposure by eating something as simple as a can of soup.
I can no longer go into most restaurants, I can eat no fast food due to cross-contamination issues in cooking, I cannot eat food prepared on a shared grill, and I can only buy packaged food products that are made of simple, organic ingredients. I am lucky that I own a business and am able to work from home, so I don’t have the issues many face by working in an environment where mammal meat is often prepared (even in a microwave), risking cross-contamination and fume reactions.
This allergy has limited my ability to move about in the world as I did just a few short years ago, as I risk exposure to harmful allergens whenever I venture out. Imagine never being able to walk into a BBQ or Mexican restaurant again, or even a grocery store with a grill, or being unable to go to a family gathering or local event, due to the risk of fume reactions. That is the life that we lead. That is the fear that we live. Every single day.
It is my strong belief that we will not have to beg for research and attention to this disease much longer. At the rates of increase that I see in numbers of reported cases, as well as the rapidly expanding tick populations, I foresee a not-so-distant future where everyone knows what Alpha-Gal Syndrome is, because a significant percentage of the population will be living in the fear that I, and so many others, live in today. Every single day.
Thank you for your work, for your serious consideration of this matter, and for your due diligence in making the world a safer place for us to live in.
One tick bite and two anaphylactic reactions later, the course of my life changed. I had no idea why I was waking from sleep with hives, swelling, and my throat swelling closed. It was severe and fast. I deduced that it must be a food allergy, but all I had eaten was red meat and vegetables. There was no information to help me connect the dots between my recent tick bite and my consumption of red meat that would send me into a life threatening anaphylactic reaction.
When I tested negative for all food allergies, my doctor asked me if I had been recently bitten by a tick. My answer was yes. Within a week, lab work returned that showed I had a severe allergy to alpha-gal, a carbohydrate that was introduced to my body by a tick bite. Alpha-Gal allergy is also known as meat allergy or Mammalian Meat Allergy (MMA). It is a reaction to galactose-alpha-1,3-galactose (alpha-gal) where the body is overloaded with immunoglobulin E (IgE) antibodies on contact with the carbohydrate. I can no longer eat any red meat because of a single tick bite. It can prove fatal if I do.
I ask you to please seek funding for research of tick borne illnesses and raise awareness of alpha-gal allergy. More and more people are suffering from tick-borne illnesses and many are unaware still that their illness comes from a tick bite. As this spreads and affects more and more people, there will be less consumers of meat, thus affecting the demand for meat. My family of four used to eat red meat at least four times a week. We no longer purchase any red meat.
Thank you for opening the discussion about tick-borne illnesses. I hope that you will see how this can easily become an epidemic that has far reaching impact on public health and consumers and suppliers of meat products. People's lives are at risk.
In 2000, I moved into a house in a lovely wooded neighborhood in Chapel Hill. Each year I would get bitten by many ticks. Four years ago I had a life threatening tongue swelling and was diagnosed with the alpha gal allergy. No mammalian meat or products with gelatin for me. I also suffer from inflammatory diseases - rheumatoid arthritis and inflammatory bowel disease which I suspect are somehow related to Lyme disease. Please add funding for research into tick-borne diseases. There are vaccines for dogs but not for people.
Hello! I am 48 years old and a mother to two grown daughters and wife of 29 years. My story begins approximately 7 years ago. The exact time is hard to pin point down because my condition went undiagnosed for quite some time despite visits to allergists and doctors.
About 7 years ago I began to have quite concerning allergic reactions as well as very distressing GI problems that were quite painful. They seemed to come in waves and would literally stop me in my tracks causing me to have to lay down until the pain subsided to the point that it was bearable or until I could get the allergic response under control with antihistamines. I couldn’t figure out what was causing this new set of symptoms and visited an allergist at least twice in one year. At which time he ran tests and the blood work came back with the common things I already knew I was allergic to such as pollen, mold, etc. Never at any time was a meat allergy or tick bite ever mentioned to me. In the mean time, I was told to take antihistamines as my reactions only continued to worsen.
After several such reactions I began to take notice of a common thread that may be causing the reactions. I noticed that the last few times I had a reaction I had eaten beef for dinner. Still not knowing anything related to Alpha Gal I tried experimenting on my own. Was there something IN the beef I was getting from the store? Possibly some sort of hidden additive my body didn’t agree with? So I purposely went to a nearby organic farm and purchased some pastured organic lamb sausage to try. I made the sausage in some spaghetti sauce that night for dinner. Sometime later which I think was around an hour and a half I was doing dishes and all of the sudden I felt extremely faint. I was dizzy almost to the point of passing out. Immediately following that I began to itch in certain parts of my body. Within about ten minute’s time I had tremors in one arm, the bottoms of my feet swelled and I broke out in hives and intense itching. I then went into full anaphylaxis. I had NO idea what was even happening and it was the most terrifying experience of my life! After this I did research on my own as I felt that the doctors had not really helped me at this point and I ran across an article online about Alpha Gal allergy. All of the symptoms fit together and I promptly stopped eating mammal meat and did not experience another horrible reaction like the anaphylaxis one for quite some time. I still felt that I was sort of in this alone as I couldn’t find anyone that knew about the “red meat allergy”
I continued to eat everything I was before except the actual mammal meat as I knew literally nothing about it. Then about 4 years ago I started to get a very unusual rash across one side of my face. The rash would flare up quite badly and last for months on end. I went to a Dermatologist and was told I had Rosacea. I questioned that particular doctor about my allergy to mammal meat and whether that could be related in some way? His response was “well do you still eat dairy?” when I said yes he said well it’s not that then it’s rosacea. I was a little confused by this answer but took the prescription home and never filled it. I had looked at various pictures of rosacea and it just didn’t seem to look the same to me. About 7 months later I started to decline in my health. I began to have joint pain and I started to have a very strange feeling inside of my mouth. Almost like my mouth was constantly irritated. I woke up one morning and was very ill with sores covering the inside of my mouth and going all the way down the back of my throat. My mouth was so dry that I could barely swallow and I lost about 30 lbs in a month because I couldn’t eat and had a lot of difficulty swallowing. I was still getting the rash on my face as well. I went to an Ear, Nose and Throat MD who examined my mouth and throat and had no idea what it was and told me to gargle with peroxide. I went to my regular MD who thought I had an autoimmune disease and ran blood work. I had several things show up like a positive ANA test and possible Lupus antibodies. I would need to go to a Rheumatologist and couldn’t get an appointment for months. I felt very alone and scared like I had no answers or clue what was going on with me. Unable to eat or even sleep well, I started researching more about this “meat allergy” thing. I found articles that some could not consume dairy and other ingredients as well such as gelatin. I immediately out of sheer desperation stopped consuming all mammalian products at that time on my own. I found an allergist at Vanderbilt that actually knew what the condition was and had him test me at that time. The test came back positive for Alpha Gal Allergy. At least I had a confirmed diagnosis. Having something tangible to go by was a relief. As I continued to stay off of all mammalian derived products including what I put on my body, clothes and cleaned my home with and of course what I ate I began to notice a marked difference. It took my body a while to recover somewhat but after about 3 months the sores in my mouth and throat were gone. The rash on my face totally cleared up and has not been back for four years. By the time I made it to the Rheumatologist some months later the rash, mouth sores and even the ANA reading and Lupus test was all normal. He tried to convince me to take medication anyways even though my dietary changes seemed to be helping a lot of my symptoms. I declined the medication.
I am grateful for these symptoms getting better although I seem to have some intermittent symptoms that did not go away since that time. It’s almost as though my body went through a change that it has not recovered from since that time. I still have persistent joint pain, terrible fatigue and hair loss sometimes by the handfuls. The lining of my mouth has not been the same since that time although the sores never returned the inside of my mouth seems to get irritated very easily and I suffer from bouts of very dry mouth since that time.
The physical symptoms are quite scary but to me I think that the emotional toll this condition takes on a person is even worse. At a time in my life that my husband and I have become empty nesters and able to do more together, I feel as though I’ve lost so much freedom in my life. I wish others could understand that just by simply making some changes in our society and the way we do things this could make our lives so much better. Here is what I mean by this: When I just simply go out to a restaurant to eat many servers don’t even know exactly what a mammal is and have no clue whether it is in my food. Due to this general ignorance it terrifies me that even if they say” oh yes it’s free of mammal” is it really and can I trust them? I have to carry an epi pen now and it’s just not worth it to me to take the risk of using it. My choices are to either interrogate the chef, waiter and anyone in the kitchen that there is “no mammal in that right?” “ and “ you cooked mine in a separate pan and not on the grill with beef right?” and other nerve wracking questions. I have always been a very reserved person so going into this “crazy thing” with family, friends and restaurant staff looking on is just very stressful to me and somewhat embarrassing. My other choice is to go and enjoy the company and watch everyone else eat, or I can try to locate a Vegan restaurant and ask my family and friends to be Vegan for the night. At least they know what a mammal is at a Vegan restaurant, I hope?
Another thing that causes those of us a huge amount of stress and fear is the medical field itself. Many times doctors and even allergists have never heard of the condition. Because medical professionals are not educated on this condition I feel like my life may be put more in jeopardy if I am to need emergent care or surgery because the medicines are not adequately labeled with mammal derived ingredients and many times medical personnel do not have the time or inclination to call the manufacturers of these medications. It is a terrible dilemma that desperately needs to be changed so as to not further endanger our lives, not to mention it’s terrifying to go to the hospital and possibly have medications pumped into you and not know if they understand the nature of your allergy or whether this medicine contains it. It would be much like someone having a severe peanut allergy and using medications or products on them with peanuts in it to treat them. Many times even pharmacies don’t get this as my last medicine was packaged in gelatin capsules when they were told I am allergic mammal. In many avenues of our lives trust is lost. It’s not a good situation.
Another very life altering situation is purchasing food at the grocery store. Trying to navigate a food label and whether this particular ingredient or that one is derived from a mammal takes such a ridiculous amount of detective work that many of us don’t have the time or energy to do this. If companies could do this type of leg work for us by placing on the label whether the product contains mammal or not just as it does peanuts they may see a steady rise in their product sales for those that don’t contain mammal because we will just simply be able to purchase it instead of it not being worth our time to call.
Labeling on many foods have hidden or non listed ingredients such as “natural flavoring” which to most of us that have AGS is a red flag that screams, “this could be mammal but who knows?” I have also had to call sausage manufacturers to ask them if their sausage or meat sticks have mammal casing only to find out it does indeed contain this but was not written at all on the label. I try to make a point to tell these people that there is a whole group of us severely allergic to mammal and not labeling this at all could be very detrimental to a part of their customer base. There is also something called “meat glue” that is added to deli meat that could contain mammal even in turkey. It is not labeled as such. We walk through a veritable land mine each day just trying to live and eat safely.
Since being bitten by this tick and developing this condition I hope you are able to see how much my life and freedom has been affected. From just being able to enjoy a quick spontaneous dinner out with friends or go away from our home on vacation to going to the grocery store or having an emergency medical situation it seems that every part of my life has been touched by this in some way. I feel that I really fell through the cracks with the medical paradigm from the allergist who specializes in this type of thing to my general MD and was essentially forced to diagnose myself, research what I thought my problem was and take action to heal myself and not feel supported by the medical field through that process. Because of that and the ignorance and unavailability of the information about the products used in the medical field I am quite apprehensive about seeking any medical intervention.
If food labeling could be changed and medicine labeling could be made clearer for those that have Alpha Gal Syndrome it would take at least a portion of the fear from our life and maybe even restore some of our freedom and enjoyment in life. I am praying that research will be made more possible and that a cure will be found for this condition. I think we are on a very dangerous footing that a Vector borne allergy exists and is beginning to sweep parts of our nation. With the spread of this condition it could really affect the economy, our military if the troops are subjected to this and trying to accommodate safe food for them if diagnosed and even major portions of our food industry such as the beef, pork and dairy industry. At the very least I hope the Emergency medical personnel, hospitals and schools will receive training and tools to deal with this until a cure can be found. I thank you for your willingness to listen and to offer a helping hand to those affected by this terrible condition.
Dear Members of the Tick-Borne Disease Working Group:
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 11,000 physicians and scientists. 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 as infectious diseases physicians, public health practitioners, and scientists is for all patients to achieve the best possible outcomes.
IDSA comments below reflect our understanding of the contents of the Working Group’s draft report based upon the discussion at the Working Group’s June 20 meeting. We are deeply troubled that we have only 7 business days following that meeting to submit comments in time to inform the Working Group’s report. We are further concerned that there is no plan to provide an opportunity for the public to review and comment upon the draft report before it is finalized. Unfortunately, this is consistent with a pattern of behavior by the Working Group to limit public feedback on its work and, particularly, to stifle the voices of physicians who use sound, evidence-based science to direct care for their patients. Previous comment periods have provided extremely limited time to review Working Group materials.
Further, several of the Working Group’s subcommittees completely excluded volunteers with evidence-based scientific viewpoints, and the makeup of the Working Group itself is skewed in favor of individuals whose perspectives do not align with the overwhelming bulk of scientific evidence regarding the diagnosis and treatment of Lyme disease. We do not believe that the Working Group’s composition and practices align with congressional intent and we are extremely worried that the biased approach favored by the Working Group may produce a report containing recommendations that, if implemented, would cause significant harm to patients and public health.
IDSA is pleased that some of the draft report’s chapters offer important recommendations that can strengthen the federal response to tick-borne diseases. We offer our support for these recommendations in our comments below. We also express concern about several recommendations that would weaken our rigorous scientific approach to the diagnosis and treatment of tick-borne diseases and subject patients to substandard, ineffective and even dangerous care. We urge the Working Group to exclude such recommendations from its report. We would welcome the opportunity for ongoing dialogue with the Working Group to help ensure that its recommendations best serve the interests of patients and public health.
Epidemiology and Ecology Chapter
IDSA supports the recommendations for more funding and studies on the ecology and surveillance of ticks, particularly in regions where the burden of disease may be changing or is not well understood. More funding is also necessary to keep pace with the discovery of novel tick-borne pathogens. According to the Centers for Disease Control and Prevention since 2004 there have been seven new human pathogens discovered in ticks, and it is necessary to characterize these novel infections as quickly and accurately as possible.
We also agree with the subcommittee that additional surveillance and epidemiology are required to understand the burden of tick-borne infections, particularly as the endemic area for some disease-bearing tick species is expanding. Proper diagnosis of a tick-borne illness will be hampered if clinicians do not have access to accurate information detailing the burden of disease in their area. While the IDSA acknowledges that the CDC case definition for Lyme disease is intended for use as an epidemiological tool, it is incorrect to promulgate the notion that the components of the surveillance definition should not be used for clinical diagnosis. To further popularize such a statement would cause unnecessary confusion among clinicians and may lead to more inaccurate diagnoses. The clinical diagnosis of Lyme disease rests on the foundations of objective clinical findings and/or laboratory testing. The language used by the Working Group appears to have the intent of inappropriately broadening the definition of Lyme disease to include patients with only fatigue, pain or other subjective conditions. Such a change would likely lead to many more patients being inaccurately diagnosed with Lyme disease; being subjected to unnecessary, unhelpful, and potentially harmful treatment; and losing the opportunity for accurate diagnoses and appropriate treatment of other healthcare problems. We emphasize that any new approaches for expanding surveillance of tick-borne diseases must meet rigorous, evidence-based standards to ensure accuracy.
IDSA greatly appreciates and supports many of the recommendations made in the prevention chapter. A new vaccine that is safe and effective in humans would be an excellent tool for the prevention of Lyme disease. We also appreciate the acknowledgment of the barriers to acceptance of a new Lyme disease vaccine from the public and industry perspectives, and we hope the Working Group can more explicitly detail strategies for overcoming these challenges. IDSA also believes further research into vaccines that target the disease reservoirs and vectors would be greatly beneficial to prevention efforts.
We also support the Working Group recommendation to conduct studies to determine effective interventions for reducing the incidence of tick-borne diseases in humans, including novel approaches to vector control, and comprehensive vector control programs that encompass both mosquitos and ticks. Vector control for ticks is not nearly as well understood as vector control for mosquitos and would greatly benefit from further study. Education of at-risk populations is another important prevention strategy that should be better used in endemic areas.
Causes and Treatment Chapter
IDSA acknowledges that some patients who are successfully treated for Lyme disease continue to suffer from persistent symptoms after treatment. Further research into the exact causes of these symptoms is vital to developing safe and effective treatments for these patients. IDSA supports additional research to discover better indicators of active Lyme disease infection to help clinicians and patients understand microbiological cure. The FDA-approved B. burgdorferi serologic test inherently is not able to distinguish active versus past infections, which is true of many antibody-based tests.
It is important that federal research funding is geared toward such studies that will truly enhance our understanding of Lyme disease. Conversely, there is not a pressing need for additional federally supported research on antibiotic treatment for Lyme disease. There is clear, widely accepted scientific evidence indicating that a 10-28 day course of antibiotics, depending on the stage of Lyme disease, will kill the Lyme disease bacterium in humans. Despite multiple clinical trials on this subject, there is no robust scientific evidence supporting the use of long-term antibiotic therapy in patients with Lyme disease that gains them sustained benefit either as initial therapy or prolonged treatment for long-term symptoms.
IDSA agrees with the Working Group that therapeutics for symptoms that persist after Lyme disease treatment would be greatly beneficial. We support further research that would develop a better understanding of why some patients do not improve after antibiotic therapy. We also support the conclusion that the efficacy of antimicrobials for treatment of acute Lyme disease in well-defined patient populations is well documented, and add that additional long-term antibiotic treatments have not demonstrated any clinical benefits.
One area does deserve consideration of further treatment study. The inflammatory state of Lyme arthritis often takes weeks or months to resolve; however, patients are often subject to multiple additional courses of antibiotic that are of unclear worth. Late Lyme arthritis, classically causing a swollen knee, has not been subject to a large, well-designed clinical trial to determine the appropriate type and duration of antibiotic therapy. Moreover, the 10-15% of patients who experience antibiotic-refractory Lyme arthritis have not been subject to prospective trials to determine the best anti-inflammatory strategies to resolve their condition. A multi-center study to address the best antibiotic treatment for Lyme arthritis would significantly help answer these fundamental questions and also lead to identifying patients who do not fully respond to antibiotics and could enter a subsequent study for antibiotic-refractory arthritis.
It is essential that research on tick-borne diseases meet established standards for scientific rigor to ensure that study results are meaningful and can safely and effectively guide patient care. Attempts to make clinical trials more inclusive or pragmatic must not override the need to ensure that enrolled patients have Lyme disease based on widely accepted standards.
Clinical education on the diagnosis and treatment of tick-borne diseases must continue to rely upon robust scientific evidence and should not attempt to undermine medically appropriate diagnostic practices. Except in rare cases as true with all infectious diseases, Lyme disease causes well-characterized presentations. Over-testing and over-diagnosis of Lyme disease can lead to patients who do not have Lyme disease receiving unnecessary and potentially harmful treatments. This practice can also cause clinicians to overlook and fail to diagnose other conditions, such as multiple sclerosis, cancer, or fibromyalgia, those robbing patients of the opportunity to receive appropriate therapies. While IDSA continues to call for more research to improve diagnostic tools for Lyme disease, it is essential that clinical education is rooted in the best currently available evidence.
IDSA greatly appreciates the Working Group’s recommendations for increased research to improve Lyme disease diagnostics. Lyme disease is diagnosed by a combination of medical history, physical exam, and if needed, diagnostic testing. The current FDA-approved serologic tests work best for patients who have symptoms beyond the first two to four weeks as this is the typical response time for the human immune system to make antibodies against a pathogen, such as Borrelelia burgdorferi. In patients who are just infected, the diagnosis is best made if the characteristic rash, erythema migrans is present as patients are frequently seronegative. Current, clinically-validated FDA tests are the best available tests for diagnosis of Lyme disease when the characteristic rash or history is not present. Scientific advances are needed to improve testing strategies for the earliest phases of Lyme disease.
As serologic tests may remain positive for decades after successful treatment of Lyme disease, development of a test that provides supportive evidence that a patient has been microbiologically cured of infection would be of great benefit. Particularly for a patient who has persistent symptoms after antibiotic therapy, this would assist in guiding their clinician to avoid unnecessary additional antimicrobial therapy. IDSA has long advocated for more funding and research into more accurate and specific diagnostics. Progress in this area would greatly reduce misdiagnosis and link patients to effective treatments more quickly.
Important strides have been made to support the development of new diagnostic testing procedures. The NIH and CDC initiated a Serum Reference repository in 2008 and, at the end of 2011, began making standardized Lyme disease cases with serum samples available to the scientific community on a broad basis for testing and comparison of new diagnostic tests. The repository enables comparison of newly developed and existing diagnostic tests under identical conditions using the same panel of well-characterized reference specimens. CDC is also developing next-generation direct diagnostic tests (e.g., biomarkers) to improve upon current serological tests. However, the development, validation and commercial distribution of new tests can take years and millions of dollars.
Access to Care Chapter
While IDSA supports creating a federal repository of information on Lyme and other tick-borne diseases, it is critical that all of the information be science- and evidence-based to ensure patients receive the highest level of care possible. Increased federal funding for tick-borne diseases is vital, but this funding cannot come at the expense of funding for other diseases, including HIV. Pitting one disease against another is counterproductive and costly. As has repeatedly been evidenced, we must sustain our efforts in responding to infectious diseases or risk serious and potentially deadly outbreaks, as we have already seen recently for HIV due to the opioid epidemic.
IDSA supports patient access to evidence-based, medically appropriate diagnosis and treatment of Lyme disease and persistent symptoms that is safe and effective. We oppose policies that would subject patients to faulty diagnostic procedures or dangerous or unproven treatments. We also oppose recommendations or laws designed to protect clinicians who provide harmful treatments. In addition, we oppose any attempts by the Working Group to undermine widely accepted medical guidelines for the treatment of Lyme disease that are rooted in scientific evidence or to promote clinical guidelines that are not evidence-based. We are extremely worried about the potential impacts of the recommendation to provide protections for doctors who follow “recognized guidelines.” The term is exceedingly broad and could easily be applied to guidelines that lack sufficient evidence. This recommendation was adopted by a margin of only one vote, by far the most contentious vote of the meeting, yet due to the composition of the chapter’s writing group, the report will contain no minority opinion on this issue. This is a significant oversight, and we strongly encourage the addition of a minority opinion on this issue. Broad protection for physicians who subject patients to substandard or even dangerous therapies will likely result in an increase in the number of patients who are harmed.
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 the interests of patients and public health. Below we are pleased to offer a compilation of the published evidence that has informed our comments. We hope these resources will be of use as the Working Group prepares its report.
Paul G. Auwaerter, MD, MBA, FIDSA
- Centers for Disease Control and Prevention. Vital Signs: Trends in Reported Vector-borne Disease Cases- United States and Territories, 2004-2016. Morbidity and Mortality Weekly Report. May 4, 2018.
- Aguero-Rosenfeld, M. E., et al. (2005). "Diagnosis of lyme borreliosis." Clin Microbiol Rev 18(3): 484-509.
- Barclay, S. S., et al. (2012). "Misdiagnosis of late-onset Lyme arthritis by inappropriate use of Borrelia burgdorferi immunoblot testing with synovial fluid." Clin Vaccine Immunol 19(11): 1806-1809.
- Branda, J. A., et al. (2017). "Advances in Serodiagnostic Testing for Lyme Disease Are at Hand." Clin Infect Dis. 2018 Mar 19;66(7):1133-1139. doi: 10.1093/cid/cix943.
- Marzec, N. S., et al. (2017). "Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease - United States." MMWR Morb Mortal Wkly Rep 66(23): 607-609.
- Baker PJ. Straight Talk About Chronic Lyme. The American Journal of Medicine. June, 2018.
- Cook, M. J. and B. K. Puri (2016). "Commercial test kits for detection of Lyme borreliosis: a meta-analysis of test accuracy." Int J Gen Med 9: 427-440.
- Costello, J. M., et al. (2009). "Lyme carditis in children: presentation, predictive factors, and clinical course." Pediatrics 123(5): e835-841.
- Dersch, R., et al. (2016). "Prevalence and spectrum of residual symptoms in Lyme neuroborreliosis after pharmacological treatment: a systematic review." J Neurol 263(1): 17-24.
- Diuk-Wasser, M. A., et al. (2016). "Coinfection by Ixodes Tick-Borne Pathogens: Ecological, Epidemiological, and Clinical Consequences." Trends Parasitol 32(1): 30-42.
- Stafford KC, et al. Integrated Pest Management in Controlling Ticks and Tick-Associated Diseases. Journal of Integrated Pest Management. October 17, 2017.
- Lantos, P. M. and G. P. Wormser (2014). "Chronic coinfections in patients diagnosed with chronic lyme disease: a systematic review." Am J Med 127(11): 1105-1110.
- Oksi, J., et al. (2007). "Duration of antibiotic treatment in disseminated Lyme borreliosis: a double-blind, randomized, placebo-controlled, multicenter clinical study." Eur J Clin Microbiol Infect Dis 26(8): 571-581.
- Roaldsnes, E., et al. (2017). "Lyme neuroborreliosis in cases of non-specific neurological symptoms." Tidsskr Nor Laegeforen 137(2): 101-104.
- Stanek, G., et al. (2011). "Lyme borreliosis: clinical case definitions for diagnosis and management in Europe." Clin Microbiol Infect 17(1): 69-79.
- Steere, A. C., et al. (1998). "Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. Lyme Disease Vaccine Study Group." N Engl J Med 339(4): 209-215.
- Arvikar SL, Steere AC. “Diagnosis and Treatment of Lyme Arthritis.” Infectious Diseases Clinics North America. 2015. 269-280
Is it Possible to Make a Valid Diagnosis of Lyme Disease Based on Symptoms Alone?
Lyme disease has been defined historically in the United States as a tick-borne infectious disease caused by a bacterial spirochete, Borrelia burgdorferi sensu stricto (1). It also has been called “the great imitator” because its symptoms are said to resemble those associated with several unrelated medical conditions. However, the fact that there are more than 350 medical conditions with symptoms very similar to those often attributed to Lyme disease (2), renders it extremely difficult – if not impossible—to make a valid diagnosis of Lyme disease based on symptoms alone, even in situations where the diagnosis of Lyme disease might seem to be most likely. For example, individuals living in endemic areas and exposed to ticks may develop a “bulls-eye” or erythema migrans (EM) rash that may be sufficiently pathognomonic for Lyme disease to justify antibiotic therapy with no additional testing; however, such a rash is present in 70-80% -- not 100%-- of those who acquire Lyme disease, and is sometimes mistaken for other types of skin reactions (3, 4). Although some consider the appearance of facial palsy a hallmark feature of Lyme disease, it is sometimes expressed in patients with other medical conditions, including several common viral infections (5). Even in regions where Lyme disease is endemic, 3 of 4 facial palsies are unrelated to Lyme disease (6).
Annual surveys by the Centers for Disease Control and Prevention (CDC) indicate that about 15% of women and 10% of men in the general population of the United States felt exhausted or extremely tired (fatigued) either every day or most days of the preceding 3 months (7), and that about 16% of men and 22% of women experienced pain in the past 3 months (8). It is estimated that nonspecific irritable bowel symptoms affect about 11% of the general population (9). The Institute of Medicine (IOM) reports that nonspecific chronic pain affects 100 million Americans, about 30% of the general population; such individuals go from one physician to another, unable to find anyone who can identify the cause of their pain or suggest a remedy (10). Thus, individuals who believe that they have “chronic Lyme disease” might well be included in these cohorts, simply based on the presence of symptoms that are widely prevalent in the general population.
Some strongly assert that the diagnosis of Lyme disease is a “clinical judgement”. Although this term can mean different things to different people, it is generally meant to be a judgement based on the results of a large body of evidenced derived from peer-reviewed research, i.e., evidence that is generally accepted by well-informed physicians in the medical community at large. To date, a PubMed search of the scientific literature reveals more than 12,000 publications dealing with practically every aspect of Lyme disease. Since its discovery in the United States in the mid-1970s, we have learned a great deal about the cause, diagnosis, and treatment of Lyme disease. It is not the strange and mysterious disease that some imagine it to be, nor is it a disease without a cure. A physician who is board certified in the specialty of infectious diseases is certainly “Lyme literate” and should know how to diagnose and successfully treat Lyme disease; so should general practitioners in endemic areas with much experience treating patients with Lyme disease. Lyme disease conforms to the same fundamental rules and principles that apply to other infectious diseases. This likewise applies to the host immune response to B. burgdorferi and/or its various cell surface antigens. There are no “special rules” that apply only to Lyme disease, and one does not need to acquire “special training” or insights in medical school -- or anywhere else for that matter—just to learn how to diagnose and treat Lyme disease. Although there is abundant knowledge upon which to base a rational clinical judgement, the results of an approved and correctly performed objective laboratory test certainly are invaluable in making and/or confirming the validity of a diagnosis of Lyme disease.
The accuracy and reliability of two-tier testing, which has long been accepted as the standard procedure for the laboratory diagnosis of Lyme disease, has been discussed in great detail (11, 12); however, there is much false and misleading information about its development and use. For example, it is often stated that the criteria used for the interpretation of Western blots used in the second step of the two-step procedure were selected arbitrarily. Instead, they were based on the results of a rigorous statistical analysis of Western blots for 225 case and control subjects revealing 8 IgM bands associated with early infection, and 10 IgG bands detected 4-6 weeks after infection. When receiver operating characteristic (ROC) curves, which are plots of sensitivity vs specificity, were constructed for the most common IgM bands detected in early disease, as well as for the most common IgG bands detected after several weeks of infection, the area under each optimal ROC curve indicated that the minimum number of bands required to obtain 99% specificity, was at least 2 for IgM bands, and at least 5 for IgG bands; this gave the greatest incidence of unequivocal positive values in combination with the lowest incidence of false positive values (13). These objective findings provide the foundation for the criteria recommended by the CDC for Western blots now being used in two-tier testing for Lyme disease (12). Note that recombinant proteins now have replaced undefined whole-cell sonicates as ligands in Western blots; this has not only increased sensitivity and precision, but also has considerably reduced intra-laboratory variation in the results obtained.
Comparisons were made between the results obtained using the standard two-tiered test procedure vs those obtained using ELISA tests performed with whole-cell sonicates (WCS) or different well-defined and highly specific peptides (C6 or VlsE) as ligands. They showed that, in assays of specimen samples collected 4-6 weeks or longer after infection, there was complete agreement in all cases, thereby confirming the reliability of standard two-tier testing done late after infection (13). However, for comparisons made using specimens from patients with acute EM and during early infection, greater sensitivity (25-50%) was noted for ELISAs using the defined ligands than for ELISAs using whole-cell sonicates (16-38%; 13). Since Borrelia replicate (divide) at a slow rate (once every 12 hours), it may not be possible to realize much greater gains in sensitivity and earlier detection of antibody; obviously, it simply takes time for sufficient antibodies to be generated by the host immune system in response to Borrelia antigens, even when these extremely sensitive methods are used for the detection of the small amount of antibody produced (11). The results of other comparative studies also suggest that the use of two ELISAs conducted with defined ligands (C6 and VlsE) give results comparable to those obtained using the conventional two-tier procedure. Although this suggests that the use of two ELISAs using defined ligands might obviate the need for doing Western blots (13), additional studies are needed to establish that point.
A major disadvantage of using Western blots is that the results obtained are qualitative, rather than quantitative in nature. The use of quantitative ELISAs and specific peptides as ligands should enable one to distinguish between high levels of serum antibody that are characteristic of active infection from the low levels of background antibodies often detected in patients cured of infection. In this context, low levels of background antibody often persist for several years after an infection has been cured by antibiotic therapy; this makes it difficult to distinguish between active infection and past exposure by means of Western blots (11). The use of quantitative ELISAs should be more fully evaluated for routine use, since ELISA plate readers with relevant software have been commercially available for many years at low cost.
A second major misconception about two-tier testing is the notion that its reliability is no better than that of “a coin toss” (14). This false claim is due to misinterpretation of the results obtained early after infection -- at the time an EM is present -- when sensitivity is indeed at or less than 50%; in contrast, the situation is quite different 4-6 weeks after infection when the full array of Borrelia specific antigens can be detected. There is ample evidence to indicate that individuals infected for 4 or more weeks in duration – unless immunocompromised—are seropositive by the CDC IgG Western blot criteria (11). Therefore, one must seriously question whether individuals who claim that they have suffered from Lyme disease for long periods of time or years and are seronegative by two-tier testing, really have Lyme disease. Even the most specific and sensitive diagnostic test for Lyme disease that one can imagine will not give a positive result for an individual who does not have Lyme disease.
A third major misconception is the view that the post treatment symptoms that some patients experience after receiving recommended treatment for Lyme disease (PTLDS) , are due to a persistent infection termed “chronic Lyme disease” that requires longer antibiotic therapy with other kinds of antibiotics -- given singly or in combination-- to cure. It should be noted that the results of five placebo-controlled clinical trials on the efficacy of extended antibiotic therapy for the treatment of PTLDS, provided no evidence of a persistent infection in such patients by culture and/or other laboratory tests; the results of all of these clinical studies showed no significant lessening of symptoms which one would expect to occur if such symptoms were due to a persistent infection (15-18). Furthermore, most seronegative individuals who believe that they have “chronic Lyme disease” seldom – if ever—have evidence of a persistent infection by culture or any other laboratory test.
Some believe that reports indicating the ability of Borrelia survive antibiotic treatment in vitro mimic what occurs in vivo during “chronic Lyme disease” and suggests the likelihood of a persistent infection in patients previously treated with antibiotics. However, such in vitro studies fail to compensate for the protective effects attributed to the host immune system in vivo. More important, there is no evidence that such in vitro findings have any clinical relevance (18). The presence of antibiotic resistant “persisters” may very well be an in vitro laboratory artifact that can be explained by basic biochemical kinetics since the ability to detect “persisters” in vitro is influenced greatly by both the numbers of Borrelia and concentration of antibiotics used (20).
In view of these considerations, what is the “take home message” for those who believe that they have Lyme disease based on symptoms alone, but are seronegative by two-tier testing? There are several that could have serious consequences:
First, in view of all that has been said above on the inability to make a valid diagnosis of Lyme disease based on symptoms alone, the recommendation to treat until symptoms disappear seems most unwise to say the least. It makes no sense to treat a patient with antibiotics for long periods of time in the absence of any tangible evidence of active infection.
Second, such patients often become victims of countless unorthodox remedies claiming to cure the Lyme disease that they do not have using unproven approaches with no demonstrable benefit that may even be harmful (22). Often, this is done at great personal expense – sometimes for as much as $70K-$80K per year -- since health insurance companies will pay only for remedies known to be beneficial and safe for the treatment of correctly diagnosed illnesses. Obviously, it would not be in the best interest of the public health to pass legislation requiring health insurance companies to pay for unorthodox remedies of no proven benefit. That would increase the costs of medical care for all, making it even more difficult for those who can least afford it to obtain the medical care they need.
Third, the fixation on Lyme disease -- and only on Lyme disease -- as the sole cause of their symptoms prevents one from seeking medical advice to consider other possible causes for their symptoms. When correctly diagnosed and treated, such symptoms often can be resolved promptly, with an almost miraculous return to normal good health.
Fourth, the dissatisfaction resulting from the use of unproven unorthodox procedures for the treatment of Lyme disease, as well as the dissemination of much false and misleading information on the internet and in the media, have generated much dissatisfaction and distrust. Unfortunately, many competent scientists and physicians, who have just the expertise needed to address issues related to Lyme disease have become the targets of such negativity (22). To make matters worse, a concerted effort is being made to discredit the recommendations made by the Infectious Diseases Society of America (IDSA) in its guidelines for the treatment of Lyme disease (3). These guidelines are universally accepted by experts on Lyme disease throughout the world, and the treatment recommended has been demonstrated to be both beneficial and safe (22). No other set of guidelines has been subjected to such independent and intense scrutiny and critical review -- and survived the process intact with no revisions recommended (23). Quite simply, if we chose to abandon the rational and disciplined approaches historically associated with the scientific enterprise and the practice of medicine, then all we are left with is magic and superstition to solve our problems.
The IOM published a comprehensive report advocating a multidisciplinary rational approach for dealing with chronic pain and other nonspecific symptoms that occur in the general population and that often are incorrectly attributed to Lyme disease (10). Its recommendations make good sense and deserve to be given serious consideration and implemented.
Phillip J. Baker, Ph.D.
American Lyme Disease Foundation
- Klempner, MB, Hu, L, Evans, j, Schmid, CH, Johnson, GM, Norton, RP, Levy, L, Wall, G, Kosinski, M, and Weinstein. N. Engl. J. Med. 345; 85-92, 2001.
- Krupp, LB, Hyman, LG, Grimson, R, Coyle, PK, Melville, P, Dattwyler, AS, and Chandler, B. Neurol. 60; 1923-1930, 2003.
- Fallon, BA, Keilp, JG, Corber, KM, Petkova, E, Nelson, DR, and Sackheim, HA. Neurol. 120; 992-1003, 2008.
- Berende, A, ter Hofstede, HJM, Vos, FJ, van Middendrop, H, Volgelaar, ML, Tromp, M, van den Hoogan, FH, Donders, ART, Evers, AWM, and Kulberg, BJ. N. J.Engl. Med. 374; 1209-1220, 2016.
- Abel zur Wiesch, P., Gkotzis, S, Ocampo, P, Engelstadter, J, Hinkley, T, Magnus, C, Waldor, MK, Udekwu, K, and Cohen, T. Sci. Transl. 2015 May 13.
Dear Tick Borne Disease Working Group Members,
Please accept the following paper outlining the history and events, and in my opinion the complete failure of the LYMErix™ vaccine. As a volunteer patient advocate since the early 1980’s I had been looking forward to anything that might reduce the number of people becoming seriously ill, disabled and even dying from Lyme and other tick borne diseases. Although a vaccine sounded promising, unfortunately, shortly after its release I became overwhelmed with serious concerns and complaints from residents and others from out of state. Physicians, Lyme patients, previously healthy residents who suddenly became ill after receiving the vaccine and even pharmacies that slowly became skeptical about ordering supplies of the vaccine were contacting me for answers and assistance.
After careful review of the literature and science available I was unable to provide definitive answers for the people then, and am still, almost 20 years later, unable to explain what happened to those whose lives were changed by the Smith Klein Beecham (SKB) vaccine. Recently I came across a well-written paper that Mrs. Patricia Smith, President of the LDA (who was selected for a position in the TBD Working Group) wrote relating to the vaccine that expresses some of our concerns. Rather than “reinventing the wheel”, I would like the members of the Group to review her accurate description of events and address the concerns. Thank you!
The LYMErix™ Story: FDA Approval to Market Withdrawal- Learning from History
By: Patricia V. Smith, President, Lyme Disease Association, Inc. (Lyme Times 2013, used with permission)
The LYMErix™ vaccine (LV) by Smith Klein Beecham (SKB) was approved by the Food and Drug Administration (FDA) in December 1998 after completing a clinical trial of 10,936 people- the manufacturer concluding it was to be most effective in preventing the disease in people under age 65. Half the trial participants received an initial injection, then booster shots one month and 12 months after. Uncertainty about the length of vaccine immunity implied that recipients might need more boosters as often as every year to prevent waning immunity. The panel unanimously endorsed the vaccine for use in people ages 15 to 70. Safety and efficacy testing data for young children who were at high risk of developing Lyme disease was not available.
Six months before the vaccine’s approval, lead researcher for the LV, Dr. Allan Steere, New England Medical Center, Boston, published results (Science 7- 31-1998) of his “test tube” study showing that OspA (Outer Surface Protein A of the Lyme bacteria) could cause a "cross- reaction" with a human protein in people positive for the HLA-DR4 gene, 20-30% of the population. The immune system could attack the body’s own protein thinking it was an invading bacterium- not proof of this reaction in humans, but indicating a possible connection. The LV vaccine had an OspA base.
A month before vaccine approval, the Lyme Disease Association, Inc. (LDA) published LDA’s Vaccine Position Paper. LDA was following the development of the vaccine and was concerned that safety and efficacy had not been fully established. The Steere research pointed to a potential link between OspA and a possible unstoppable immune cascade. LDA suggested that individuals considering vaccination should get answers to the questions posed by the Paper before getting vaccinated. Before the LV’s approval, it generated so many questions and discussions by FDA panel members that Dr. Patricia Ferrieri of the University of Minnesota, who chaired the FDA advisory panel, chose to summarize the Committee’s sentiments: “It's rare that a vaccine be voted on with such ambivalence and a stack of provisos."
As a frequent speaker on Lyme disease nationwide, I was finding the predominant question about Lyme became vaccine safety and efficacy. Many other Lyme groups were reporting the same. The research on the length of protection the vaccine would provide was unclear, and after the trials, people found that the one series of 3 shots they thought they needed might now require several boosters, but even doctors did not know for sure. Information that it did not provide permanent immunity was not widely disseminated. Misinformation abounded- people came to us and said, we don’t have to worry; we can never get Lyme; we got the vaccine. Whether a person with a history of Lyme should get the vaccine was not clear to people, so some got the vaccine and some of them said their symptoms returned. Discussions raged about “healthy” people who said they “acquired” Lyme from the vaccine but perhaps really had had undiagnosed cases and that the shot had “activated” existing subclinical infection. Due to all the uncertainty, many doctors stopped giving the vaccine.
By December 1999, LV safety concerns led the law firm of Sheller, Ludwig & Badey, Philadelphia, and others to file a class action lawsuit against SKB representing all individuals getting the LV vaccine. The purpose was to put people on notice about the dangers of the vaccine and get medical monitoring for any future vaccine use.
Reporter Ridgely Ochs (NY Newsday 3-9-2000) quoted Dr. Ronald Schell, University of Wisconsin, who said, “I wouldn't take the vaccine… I recognize that's a prejudice based on my animal research.” His published study (Infection & Immunity 2-2000) found that hamsters vaccinated with OspA following infection with B. burgdorferi developed arthritis. Dr. Schell was a speaker at the now defunct Lyme Disease Foundation’s (LLDF) March 2000 conference in Hartford. I attended and followed Dr. Schell into the elevator after his presentation to discuss his hamster work, since LDA was so concerned about its relevance to the LV. SKB gave an update of the LV vaccine at the same conference, one which they also supported with a grant to the LDF, which publicly received a large check at the meeting. It appeared that the LDF initially supported the LV vaccine.
By early 2001, the LDA was so concerned with the numbers and severity of adverse events that I testified before the FDA’s Vaccines & Related Biological Products Advisory Committee (Bethesda, MD 1-31-01). Scientists, practicing physicians, SKB (by now GlaxoSmithKline), patient advocates, and vaccine recipients who claimed they were harmed by the vaccine, some in motorized wheel chairs, testified. The FDA said the issue “cannot be resolved with VAERS [Vaccine Adverse Events Reporting System] data alone, although reports of arthritic events to date do not provide clear evidence of a causal association.” SKB assured the panel its vaccine was safe and reviewed its Phase IV trial information. Some physicians said they saw reduced Lyme in their practices. Scientists discussed how OspA-related autoimmunity might be relevant in vaccine complications.
My testimony in part, “Today you are hearing about how this vaccine has physically impacted human lives. It appears that little can be done to stop whatever process triggers some of these reactions, or if something can be done, it remains as yet undiscovered. I listen to the despair and bewilderment of those adversely impacted... I do not have any answers, and I do not know who does. This committee has the authority to formulate recommendations that may prevent others from potentially suffering the same fate. You can revisit the original data and research which appears to show a link between OspA and adverse reactions and view it in light of the adverse events you have now heard about. You can recommend further studies. You can find out why many doctors who treat chronic Lyme disease are not giving the vaccine. The Advisory Committee on Immunization Practices recommends under future considerations in their report on the Lyme disease vaccine, June 4, 1999 MMWR, ‘establish post licensure epidemiological studies of safety, efficacy, prevention effectiveness, cost effectiveness, and patterns of use.’ We concur with that recommendation and would like to see a moratorium on vaccine administration until those studies are completed and the results critically analyzed.”
After hearing testimonies from all interested parties, the FDA panel concluded that the benefits of LV outweighed its risks and did not change product labeling or indications. FDA did require SKB to provide more vaccine safety and efficacy data by increasing their enrollment in the ongoing Phase IV trial.
The LDA tried to address the vaccine problems privately with the FDA after so many vaccine recipients contacted LDA about serious symptoms such as autoimmune issues they or sometimes their doctors attributed to the vaccine . Vaccinees indicated that their adverse events were often not reported, either by the administering doctor or even by the company when they called directly. The FDA spent considerable time trying to not allow us to bring in experts on the vaccine to a meeting with them, to the point of telling us we could not bring in anyone to the meeting who was not a “consultant” to the LDA, citing a “law” which turned out to be bogus.
Finally, with the intervention of Congressman Chris Smith (NJ-4), the meeting was held (Bethesda 1-22-02). We brought in a team of experts including doctors trying to help people who received the vaccine and were now physically debilitated and a researcher integral to the development of the OspA based vaccine, who served as a “volunteer consultant” to LDA. He indicated that differences in trial and post trial roll out in vaccine adverse events issues could be related to the fact that after the trials, people in endemic areas received the vaccine, and that fact could account for events of retriggering latent infections mentioned above. About a month after the meeting, FDA faxed to LDA late on a Friday night (22-22-02) answers to LDA questions prepared for and submitted to that above meeting. A few days later, SKB announced the withdrawal of the vaccine from the market citing poor sales.
The LDA was permitted by the Court to submit a letter (44-02) in support of the proposed LV settlement. In part: [Discussing the FDA hearing on vaccine adverse events]. “The FDA never took further action on the vaccine. SmithKline (now GSK) acted. Citing poor sales of the vaccine, they withdrew it from the market. The class action was instrumental in achieving this result. Its filing caused people to rethink their intent to get the vaccine. SKB agreed not to remarket it without a label change. Consumers are now protected from further harm while the vaccine is not being distributed, and if SKB decides to redistribute, they will have to provide labels which fully inform consumers about the associated risks of the vaccine.”
SKB settled the class action suits with Sheller and the other firms who had filed. According to the settlement agreement (6-30-03 Judge Jacqueline Cody, Judgment, Final Order and Decree Granting Final Approval of the Class Action Settlement, Chester Co. Court of Common Pleas), legal fees were paid to Seth Lesser (Bernstein, Litowitz, Berger, and Grossman LLP) to distribute to the Plaintiffs’ Counsel. It also stated “nothing in the settlement agreement shall be construed as releasing any claim of any Class Member for personal injury arising out of vaccination with Lymerix…” I asked Attorney Steve Sheller in a recent phone interview about subsequent settlement rumors, and he stated, “Numerous claimants who were part of the case and others who came to us afterwards went forward with the Sheller firm, and large numbers were resolved pursuant to required confidentiality agreements, thus settlement terms remain confidential.”
Since the suit was designed to warn patients of the drug’s potential dangers, the objective of the class action was primarily met with the voluntary withdrawal of the vaccine from the market. A separate proviso would require the manufacturer to go through the FDA process again for relabeling if brought back. The manufacturer never acknowledged that LV caused harm and remained firm that the decision to withdraw was due to poor sales.
Present Day Lyme Vaccine
Fast forward to the present. There is a new vaccine which has just completed Phase I/ II trials in Germany and Austria. It is OspA based, uses more than one strain of the bacteria (US plus European) and we have been told that the portion of the OspA which invoked the mimicry which started the arthritis cascade (which SKB has never publicly acknowledged occurred from vaccination) has been modified to prevent that occurrence. The manufacturer is Baxter . According to one of the vaccine’s developers, Dr.. Benjamin Luft, Stony Brook University "The results of the clinical trial conducted by Baxter are promising because the vaccine generated a potent human immune reaction, covered the complete range of Borrelia active in the entire Northern hemisphere and produced no major side effects… We hope that a larger-scale, Phase 3 trial will demonstrate not only a strong immune response but true efficacy in a large population that illustrates protection against Lyme disease."
LDA understands the value of a vaccine for Lyme disease. However, we should and do have concerns related partly to the fact there is no reliable test for Lyme disease yet, almost 40 years into the disease, nor is there one which determines active infection. How can an individual poised to receive the vaccine determine if they have a Lyme infection already, which in light of questions raised from the prior vaccine, could possibly prove dangerous to those individuals. Additionally, there have been published reports of cognitive difficulty and neuropathy including chronic inflammatory demyelinating polyneuropathy (CIDP) in LV patients. This issue also needs addressing in relationship to the new vaccine. (Norman Latov, Journal of Peripheral Nervous System 9-9-04; Donald H. Marks, International Journal of Risk & Safety in Medicine, 2011)
Questions related to the safety and efficacy of the prior vaccine do not appear to have been fully explored nor answered, but have been met publicly instead with blame being laid at the door of the Lyme community for failure of the first vaccine. In this climate, it is not really a surprise that Lyme patients and the public are concerned about a new roll out. Before that occurs, we recommend the following: 1. All the final reports/studies/research from the past vaccine, LV, need to be made public so concerned individuals can evaluate coverage of issues and corresponding analyses. 2. All of the safety and efficacy issues identified as problematic, unless proven to be false or insignificant rather than not being definitively or clearly established, regarding the past vaccine need to be conclusively addressed in relationship to the new vaccine. Claims of the effectiveness of changes from the previous to the new OspA vaccine in remedying safety concerns need to be scrutinized and verified. 3. More comprehensive and determinative research than was done for the previously approved Lyme vaccine needs to be done prior to approval on safety and efficacy. 4. Coordinated vaccine education programs need to be developed for health care providers and vaccine recipients or legal guardians of recipients. The importance of and mechanisms for adverse event reporting need to be included in education programs, as past LV recipients reported being dismissed by providers and/or the manufacturer and were unaware of the ability to self-report to VAERS. 5. Significant outreach to and education of healthcare providers needs to occur prior to rollout. 6. Listing of adverse events in label contraindications and the VAERS table of reportable events must be seriously protective of vaccine consumers. 7. Safety, immunogenicity and efficacy of the Lyme disease vaccine in children need to be demonstrated if the vaccine is recommended for them. 8. All panels which review the vaccine need to be as free as possible of professional and financial conflicts of interest─ as should always be the case.
Food for Thought
“During the past thirty years, vaccines have experienced a renaissance. Advances in science, business, and distribution have transformed the field to the point where vaccines are recognized as a "best buy" in global health, a driver of pharmaceutical industry growth, and a key instrument of international development.” (J. Stéphenne, SKB, Health Affairs 6-30-11). While these are all positive outcomes, this statement by an official of the past producer of the only Lyme vaccine ever approved, clearly reinforces the reality that vaccines are big business, and that all stakeholders- including regulators, advisors, health care providers, consumers, and advocates- would be derelict if we were not vigilant in ensuring that business objectives do not preempt the goals of public health nor the rights of consumers.
Janet Boles Jones
To Whom It May Concern,
I am writing to tell you just a bit about my diagnosis with Alpha Gal. I was diagnosed this May, and with one phone call, my world rocked.
No more red meat - that seems such a simple, benign statement. But it is more, oh so much more. No "mammal" meat is the more exact wording, and that means everything but "fins and feathers" is a possible death sentence for those of us with Alpha Gal. For many, the allergy creates a further sensitivity to other mammal offerings - milk, cheese, gelatin, many hidden products in foods, medicines and personal products.
I live in fear of having to go to the ER in anaphylaxis and being given medicines that have mammal in them (glycerin, for instance) that would kill instead of save. YES, it can be THAT severe. To my dismay, I have had encounters since May, with several specialists in different fields that HAVE NOT even heard of this, and I found myself educating the physicians as to why I could not risk certain medicines. A big one is Heparin given in surgery for blood clots, but there are oh so many more that many of us react to. It is terrifying to know that the doctors we count on have little or no knowledge of this. I have had personal encounters with Board Certified physicians in Urology, Dermatology, Pneumology and Opthalmology. At each encounter I had to decline medicines that they wanted to prescribe because of the risk (or certainty) of mammal products. Does this sound like "fake news" , well I wish it were.
I am lucky enough to live 2 hours from UNC Chapel Hill, where Dr. Scott Commins is a leader in the field of this allergy. At my last visit he spoke of the dire need for funding for research. There is currently no "reliable " blood test, and no treatment, other that avoidance. Which brings me back to the subject of much needed education in the health field, and labeling of products to include mammal meat and by products as a allergen, especially in food.
As AG victims, we collectively lose thousands of productive hours reading labels, then referring to the internet to see what they mean, and what they are derived from. We cannot go to most restaurants with our families due to fumes from mammal cooking, or cross contamination. NO, we cannot have chicken cooked on the same griddle as steak. Last week I had a melt down when I could not go with my grandchildren on an outing. My sister had to take them, because of the meats being cooked. Forget about community fund raising suppers - no BBQ plates or hot dog fund raisers for me anymore.
But those are the simple things.....as bleak as they are. The biggest fear is knowing that the majority of health care providers do not have a clue how to help me in an emergency, or how to proceed with an emergency surgery. I live on a farm. I get cut..do I risk a Tetanus Shot, or hope for the best... Flu Vaccine, Shingles, Pneumonia...all of which I am now avoiding. All medicines have to be checked with the manufacturer to see if they are "safe" and that is a laborious process that is neither simple nor fast.
This allergy is on the rise, and I see huge health costs to us a individuals and as a society as more are diagnosed, without benefit of any treatment options.
This personally affects me as a 62 year old woman, fiercely independent. I am a hunter, I have a horse and I ride and camp alone. After much angst, I have with the help of my doctor and a specially prepared emergency pack managed to regain some of my independence. But it is NEVER far from the forefront of my mind. I can no longer harvest wild game (deer) to feed my family. When I ride, what used to be the place of solace has become a place of seeing how strong I am to be able to go into the woods, risking more tick bites, and the uncertainly of any help in time to save me. I carry a fanny pack with 5 EpiPens, a rescue inhaler, benadryl, oral steroids, and anti nausea med (as reactions often begin with violent vomiting before potentially progressing to full anaphylaxis.
This pack is my constant companion, even to the grocery store. I indeed now know what a dog on a chain feels like. I am chained to this life threatening allergy. I will remain chained until a cure or vaccine can be found. Again I am 62. I want what was supposed to the reward for a life hard worked, and well lived, back. I do not have that now.
I am writing this from a personal and emotional view, and can only vaguely begin to describe what living with Alpha Gal is like. Most concerning is that you "SIMPLY NEVER KNOW" when it is going to "hit", as this allergy, unlike other food allergies, has a delayed reaction time. What I eat at lunch may wake me up in the middle of the night in a life threatening event. The struggle to be away from immediate help is real, and for some is very disabling. I know of people who have sold their homes to move within a EpiPen distance (20 minutes) of a hospital. YES, this is so horrible that people are chaining themselves to a location in (warranted) fear. I know of several that have had to give up their livelihood (cattle and dairy farmers) due to exposure. Many of us are not willing or able to do that, but the knowledge that many are making such drastic changes to potentially save their lives is a collective cry for help.
Please help us by addressing Alpha Gal. I know that others more knowledgeable that myself have written with specific topics that need to be addressed, so I won’t go further with that. I do hope this will help you see a brief glimpse into the lives of us with Alpha Gal. Research is so needed; into this allergy, into the ticks that transmit it to us, and into ways to help us live safely until such time as a cure/vaccine can be found.
And please, protect yourself from ticks - You Don't Want ANYTHING they Have.
Thank you for your time, and your consideration to help fund and educate. We need your help so very much.
Janet Boles Jones
Alpha Gal Allergy/Syndrome
Living in the country surrounded by trees was where my husband and I wanted to be, so that's where our house was built in 1986 in Pulaski County, Arkansas. Of course, that is a great environment for ticks also.
I enjoyed my job. I grew up in my family's restaurant business, and when my parents were ready to slow down, we purchased the restaurant in 1995. My husband quit his lineman job, so we could work the business together. We added catering services and stayed busy. My mom passed away in 2005. The following year on Mother's Day coming home from a Branson trip with my sister and daughter, I started having severe pain in my stomach. It eased some by the time I got home. The doctor seemed to contribute it to nerves due to my first Mother's Day without mom. I had eaten a hamburger for lunch before the trip home that day. I vowed NOT to eat another burger because the pain was so bad. Eventually, steak hurt me also. Then about a year later, pork started causing that severe pain. It would last hours. I vomited randomly. The doctor said 'probably an ulcer'. Could it be nerves causing this? That was my question to myself. I poured myself into my work because I loved our customers. I was unaware that the yearly tick bites were trying to kill me inside.
I ended up bringing in New Year's Day 2013 in the ER thinking I had a stroke. It was Bell's Palsy. The following week, I saw my doctor for a check up. She told me to slow down and I had the worst case of Bell's Palsy she had ever seen. I would heal but probably not completely as bad as it was. I did not drive (vision affected and dizziness) for 5 months. I also could not work. I wanted to work and be myself again but even running the register was a challenge. My brain would not work like it once did. Bell's Palsy came back again and again in the next year. Looking back, it coincided with getting shots containing mammal ingredients. Test after test came back negative. I would be up vomiting nearly every night between 1am and 3am. We searched for answers as more and more symptoms appeared. My sister saw something about Alpha Gal and told me to get tested. My doctor sent me to an allergist for testing. The allergist I went to thought I was crazy to ask to be tested. My skin test did not show an allergy to beef or anything I was reacting to. Why did my throat swell when eating raw carrots and celery and bananas? She said has to be preservatives and go all organic. I practically begged for Alpha Gal testing and told her I need answers. I was then sent to a lab and five days later had answers. Within two months, that allergist informed me she had 3 more people test positive. It had taken so many years to finally know I wasn't crazy. I was diagnosed at the end of 2014 and found a tick on me that Christmas Day after the dogs had been in the house. Two weeks after, fume reactions started, blood pressure drops started, and falling to the floor lethargic. From that time on, it has been a rollercoaster of symptoms and emotions. Restaurants are limited when you react to fumes; therefore, socializing is pretty much over. Church functions revolve around food so can no longer be involved in church activities. A friend opened pork rinds in the same room and I passed out. Medicine is limited due to fillers, and insurance won't pay for compound meds. I was sent to an anaphylactic specialist in Memphis who told me to try to find something I could enjoy without socializing because it's too dangerous for me to be around large groups. They think between taking years to diagnose and additional tick bites, my sensitivity to any mammal product is off the charts. Alpha Gal number is now 27.6 and total IgE is 7560.
We closed our restaurant in 2014. My husband built a catering kitchen and just caters now. He said he couldn't handle it all without my help. We have sold our house with ten acres (after living there for 32 years) and building a small house on an acre. My husband left one tree on that acre and I refuse to go around it. I try not to let fear control me, but I also have to remember those hitchhikers called ticks have nearly killed me and a few of our neighbors. Our neighbors don't have Alpha Gal but Rocky Mountain Tick Fever has taken it's toll in our area. I can't go to a zoo with our grandchildren. Just getting near dog poop/urine or horse poop has caused diarrhea. I try to concentrate on what I can do as opposed to what I cannot to keep depression from setting in.
From May 2006 to November 2014, I had no answers to my many symptoms. If I had not pushed to get answers, I probably wouldn't be alive today. I cannot count the hours spent doing research on all products containing mammal due to continued issues and sleepless nights staying up sick. Oh and now diagnosed with asthma along with many other Alpha Gal patients. My husband says God allowed this for me to help others. I read any article I can find and research ingredients daily. Also in doing research, I have found that no matter which tick disease there is, they have many similarities. People need to be informed more about the seriousness of a tick bite and not dismissed when presenting symptoms. I believe tick diseases are more common than you think. Doctors need to become aware of symptoms and test more often for these diseases since it is much better to be diagnosed as early as possible.
I apologize for the length but was asked to tell my story and didn't know how without sharing as much as I have. I could say more but feel I have shared enough for you to get the point. Thank you for your time and efforts in dealing with tick disease.
First I’d like to thank the Tick Borne Disease Working Group for allowing and hearing the public speak regarding their experiences and recommendations to this committee. In the past I’ve written and spoken to this group about the many GAPS in respect to Alpha Gal Syndrome. Once again, I’d like to address and expand on some of those GAPS that concern me the most.
First, I firmly believe Alpha Gal Syndrome is being under reported, even by many of ‘the most well-known AGS experts’. Dr. Tina Merritt (1) reported to the AR Task Force on Alpha Gal and at the Tick Borne Conditions United’s International Alpha-Gal Webcast (2) the following information: “Dr. Tina Whytsell Merritt shared that the laboratory that does the testing for alpha gal (Viracor Eurofins) has had 58,000 positive results since they began testing. (I think since 2009) Just in the past year, nearly 14,500 positive results. (The yearly results might be a better indicator of the numbers since many of us have been tested several times through the years but not likely tested more than once a year). Also please note that the positive level (that was) used to was measured at 0.35 but is now 0.1." (Added note: This count also doesn't take into account those who do not retest for several years.) I would like to add that she’d also reported to the AR Task Force on Alpha Gal, they estimate approximately 4,000 positive AGS cases in Arkansas alone.
As you may (or may not) remember, I was finally diagnosed in April 2017, after 5 to 6 months of battling the common, escalating symptoms of AGS: extreme fatigue, joint pain, rashes, vomiting, diarrhea, GI distress & bloating, angioedema, urticaria, and 4 anaphylactic episodes, 2 nearly fatal. Despite it all, I feel very lucky and blessed for many reasons. After my diagnosis, I joined several Facebook AGS support groups, then in June of 2017, started the support and advocacy group, Alpha Gal Encouragers – NW Arkansas. In the past 15 months, I’ve read literally hundreds of stories about people who struggled with GI issues for years, tens of years, had their gallbladders removed, been diagnosed with asthma, idiopathic hives, IBS, GERD, acid reflux, put on drugs that contain mammal that make their symptoms even worse, honestly - the list is endless. One reason I feel blessed? Despite the near fatal anaphylactic episodes, I only struggled for 5 to 6 months before my proper diagnosis. In fact a recent Oxford Medical Case report (3) published February 21, 2018 reported an average of 7.1 years to be properly diagnosed and “Delayed diagnosis of an allergy that has proven to elicit such potent reactions is exceptionally dangerous.” Indeed it is “exceptionally dangerous,” lack of proper diagnosis is potentially DEADLY. And yes, there are cases we are aware of that people have died from the allergic reactions from AGS.
Education, Education, Education is a MUST for the public and in our medical and emergency services fields. Too many doctors are misdiagnosing for too long risking lives. Too many doctors don’t believe in most tick borne illnesses, let alone one that causes severe and sometimes deadly reactions to mammalian. Too many doctors think all we have to do is ‘avoid eating meat’ when it’s SO much more than that. Too many doctors have just plain never heard of it before, my general practitioner had no idea why I tested positive to beef and simply sent me to an allergist. To many doctors have no clue and even ridicule their patients when their patients suggest it or ask for testing. We are truly ill, have severe allergic reactions and are seeking proper medical care. Is that too much to ask? We don’t think so. There is no cure for Alpha Gal Syndrome, instead we have to be hyper vigilant every minute of every day to avoid the triggers that cause the allergic reactions. GAP
- Educate physicians to listen and act when patients say they’ve been bitten by tick(s) that tick borne illness is much more prevalent that they may think – especially in known heavily tick populated states.
- Educate physicians, allergists, hospitals, emergency room personnel, medical responders about Alpha Gal Syndrome, its known symptoms / delayed reactions, how to test and treat patients with products / medications that do not contain mammal by-products.
- Educate and increase public awareness to tick prevention, illnesses, symptoms and reactions so they can seek out knowledgeable physicians.
- Include tick borne illnesses (including AGS), symptoms, reactions and proper treatment in all medical schools, emergency services training and medical sources of mammal in products, products like gelatin (4)(6), magnesium stearate, glycerin, lanolin, Vitamin D3, Natural Flavoring (not regulated), etc. ; we also have to look for hidden dairy sources such as whey, lactose, casein, etc. But dairy is easier these days, so is gluten because of product labeling that says, contain no dairy/dairy free or gluten free. GAP
- Labels currently say Vegan or have a symbol – labels could say AGS safe, have a symbol or mammal free.
- Labels currently say – May contain traces of wheat, soy, etc. – they could include, traces of mammal.
- Labels currently say – Produced in a factory that processes peanuts, wheat, etc. – they could include mammal.
- Train pharmacists to routinely utilize The Robert Wood Johnson University Hospital drug information service database to check medications for mammal and dairy by-products.(5)
- Require drug manufacturers to have warning labeling – contains mammal by-products such as gelatin (4)(6) lactose, etc. Example: A well-known inhaler, Respi-Click lists ‘powder’ as an ingredient – the powder is lactose/milk powder.
- Require vaccination manufacturers to have warning labels – contains mammal by-products.(4)(6) Educate and train physicians and pharmacists of the known warnings and dangers of vaccinations that contain mammal.
Educate care staff and food services staff in hospitals, schools, pre-schools, day care services, elder care facilities, nursing and rehab facilities about Alpha Gal Syndrome and the strict dietary needs. They wouldn’t give a single peanut to someone with a peanut allergy, so don’t just remove the piece of ham or bacon you had on the plate, or tell the person, just don’t eat it. And yes, we hear these stories in the support groups all the time. They need to be trained to recognize the delayed symptoms and on-set of reactions. GAP
- Prepare, distribute educational posters (USDA safe food handling? FDA?, OSHA?, Federal or State Health Depts?), that must be posted in food preparation areas in public care facilities. Similar to the Handwashing Sign laws/posters.
- Educate and train food preparation staff as to just how deadly even a small amount of mammal or cross-contamination could be.
Insurance. Whether it be AGS or other tick borne diseases, many tests and treatments are not covered. They need to be. We didn’t ask to be bitten by a tick and get a tick borne illness, but we have them. Many of us have more than one tick borne illness (not co-infections – they don’t co-exist, they are TOTALLY different diseases/illnesses and need to be recognized as such and treated as such. Several of my AGS annual tests are not covered by my insurance. They are considered ‘Investigative and Exploratory’ and I am expected to pay out-of pocket. Of course they are investigative and exploratory – tick illnesses are considered ‘not the norm’ and for some reason not covered. Stop punishing the patient for being sick due to a tick bite. Stop punishing us and our pocketbooks for tick borne illnesses and the tests required to diagnose and treat them properly. GAP
I am not phobic and/or afraid of ticks and ticks bites, but I am extremely vigilant with tick protection now. I truly believe as the public, doctors, etc. become more aware of the delayed symptoms and reactions caused by AGS the number of people properly diagnosed is going to increase exponentially. In one sense, that’s a good thing because people who have been struggling with health issues for an average of 7.1 years before they get diagnosed will finally be able to start to feel better knowing what the trigger and cause is so they can avoid it. But in another way, it’s also not necessarily a good thing because we know the Lone Star tick and now the Asian Longhorned tick AGS link to AGS in Japan) are the cause, but what is being done to stop and / or curb their dramatic growth in numbers? What’s being done to educate the public to all tick borne illnesses to prevent them?
Once again, thank you for your time and attention to studying and reporting your findings and recommendations on these growing pandemics.
Founder / Outreach Coordinator, Alpha Gal Encouragers – NW Arkansas
- https://allergyasthmaclinicnwa.com/our-providers/ - and - https://tinahatley.wordpress.com/2012/08/26/the-alpha-gal/
Dear Tickborne Disease Working Group,
I am writing to explain how deeply affected my family is by Lyme disease, alpha gal syndrome, and other co infections of Lyme.
My husband and I have a large family of eleven wonderful children. Spring of 2015, at my grandmother's funeral in Southwest Missouri, several of us were bitten by ticks. Many of us never saw the ticks on us, but some of us did pull ticks off. I am an RN, and I knew to look for the characteristic Lyme rash. I had never been educated about other possible tick infections, alpha gal, or even that only 20-40% of people who contract Lyme disease display a bulls eye rash.
On October 2, 2015, my 3rd child had a sudden onset of autoimmune encephalitis. It took us a month to find a doctor who knew what was going on. We were incredibly blessed to have a Lyme literate doctor only 30 miles away from our residence in Arnold, MO. This doctor saved my son's life. She did appropriate testing, much of which was out of pocket through Igenex because test results from two national labs were negative. My son was CDC positive for Lyme through Igenex, had both babesia microti and babesia duncani infections, received a clinical diagnosis of bartonella, and had multiple other infections including EBV, CMV, HHV6, and mycoplasma.
My son's immune system was shutting down, he lost 25 lbs in 3 months (from 100 lb to 75 lb), was on the verge of a feeding tube, and had severe psychiatric symptoms from the infections in his brain. Our insurance denied coverage of IVIG (intravenous immune globulin), so we paid out of pocket for the first one. The cost was roughly $7,000 on top of multiple supplements and the Lyme doctor fees, none of which were covered by insurance.
I can't fully explain the fear my husband and I felt seeing our strong young boy dying within 3 months of being diagnosed with Lyme and co infections. What made this fear worse was that no local doctors besides our Lyme doctor believed us. They had very little education on diagnosing or treating tick illnesses. My son had severe psychiatric symptoms (now gone with treatment), and we were afraid to take him to the ER for help. If he had been admitted to psych, they would've pumped him full of anti-psychotics, not antibiotics or medicines to treat his infections and decrease brain inflammation. We felt very alone.
My son has his 30th monthly IVIG infusion next week for his immune system. We have had to transfer his care to a doctor 7 hours away in Ohio. This is the closest doctor who knows how to treat him. My son missed a full year of middle school. He lost the ability to read! As the Lyme and co-infection treatments killed the infections and decreased inflammation, he slowly recovered. It's not unlike healing from a stroke. We rented a hyperbaric oxygen chamber for 7 months, yet another very expensive out of pocket treatment. It was worth it because this healed his brain so he could read and do school work again. We also did neuro feedback, another out of pocket therapy; that unscrambled the faulty brain connections from the Lyme infection.
I am ecstatic to say that my son is 15 1/2 now. He has his driver's permit and will be a sophomore in high school. The school gives him some slight accommodations due to him missing a lot of school for IVIG infusions. However, he was a straight A student last year and did normal activities (besides no gym to save his energy). Had we not received top notch care from knowledgeable Lyme doctors, my son could have died. At the very least, he would've remained disabled. He has a chance at a normal, productive life now.
My son was so very ill! A good way to describe it is that my son had brain cancer. Except no one knows or believes brain cancer exists. Maybe one or two doctors in the state risk their careers to treat brain cancer, since it doesn't exist anyway.
As we treated my son for his tick illnesses, I began to notice my health failing along with some of my other children. In December 2017 I was diagnosed with Lyme by a CDC positive western blot through Labcorp. The doctor believed that my immune system had been stronger, therefore it made plenty of antibodies to have several positive bands on the Labcorp testing. I was also diagnosed with bartonella clinically due to my foot and shin pain and characteristic rash. My alpha gal IgE testing came back positive, confirming what I believed was a new onset allergy to mammal meat and byproducts.
Alpha gal allergy has completely changed my life. Besides avoiding beef, pork, and any mammal meat in my diet, I have to search carefully for mammal byproducts that are not clearly labeled on food labels or medications. Magnesium stearate and glycerin are commonly found in medicines, yet I have to call multiple manufacturers to see if they are mammal sourced. I have to search for words like gelatin, lanolin, natural flavors (often mammal-derived). I can't be in the same room as bacon or hamburger cooking or my body begins a low-level anaphylaxis. I can't be outside during a family barbeque and smell the burgers cooking. I carry an epi-pen and Unisom sleep melts with me everywhere (the only form of OTC benadryl I can find without magnesium stearate or glycerin). I am anxious at the thought of being unconscious in an accident and the doctors not understanding my medical alert bracelet. Heparin is pork-derived, and many surgical procedures involve mammal products. Education is needed for pharmacists, nurses, doctors, and anyone involved with patient care.
Doctors need extensive training on recognizing acute and chronic Lyme disease. CDC requirements for diagnosis are outdated or plain inaccurate. Doctors need freedom to diagnosis Lyme and infections clinically because testing is very inaccurate. They need to not live in fear of treating Lyme disease because their license is at risk.
Alpha gal allergy awareness is desperately needed. All hospital personnel need extensive education. All pharmaceutical medicines (prescription and over the counter), all food labels, all personal beauty care products, need clear labeling. "Natural flavorings" should never be used on a label unless it also clearly describes the source. This is life-saving for me and other alpha gal patients.
We have three other children in Lyme treatment at this time. Our medical bills consume every last penny we have, and many we don't have. This is only our story. Thank you for meeting to try to help us!
Mary Lynn Cady
Dear Tickborne Disease Working Group,
I live near St Louis, Missouri. I was diagnosed with Alpha-Gal Allergy Syndrome in 2012, after multiple episodes of hives that got progressively worse over the course of about 6 months. As I have learned more, I realize that I am one of the lucky ones with this syndrome. I realized that I was reacting to meat in a relatively short amount of time, and went to a doctor who had heard of Alpha-Gal. My doctor knew of an immunologist who had already diagnosed one previous patient just months before. So many people who suffer with AGAS have gone for years where they have been told they are crazy, or they have been misdiagnosed and treated for ailments they do not have, because so few in the medical profession know about AGAS.
When I was first diagnosed with AGAS, I felt very alone. I was sad to have to cut mammalian meat from my diet, but it seemed pretty straight forward and easy to do. Then I started having reactions again, even though I was not eating mammalian meat. I started making regular trips to my immunologist in an attempt to figure out what was happening. I also started to do more research into AGAS on my own. I cut dairy from my diet, and stumbled upon gelatin as the actual culprit in my ongoing reactions. It was about this time that I also stumbled upon AGAS support groups online, and found I was not alone. I started to learn that there is a myriad of mammalian meat byproducts that I need to watch for. Sadly, these byproducts are not just in food, and they are often hard to recognize due to a lack of labeling. Mammalian byproducts are also in medicines, vaccines, and life-saving treatments that are used routinely in emergency situations both in the field and in hospitals.
My house is in a beautiful wooded area. Wildlife abounds, and so do ticks. However this was not always the case. When we moved here in 2000, we rarely ever saw ticks, and never Lone Star ticks. Now, in 2018, it is nearly impossible to go out in our yard without getting ticks on us, and they are predominantly Lone Star ticks.
The impact of AGAS has truly been life-changing. It has not just affected me, but it has also had an impact on my family, my friends, and my co-workers. On a personal level, I am afraid to eat anywhere but home. I am afraid to travel. I am even afraid to go outside to mow my lawn for fear that I will get another tick bite. But I am even more afraid to have anyone I love go mow the lawn, for fear that they will get tick bites. So I mow my lawn. Grocery shopping is a huge event, as every label must be read. Even food I have purchased in the past might have had an ingredient change since the last time I bought it. I cannot get lazy or inattentive. My life depends on it. My family and friends are afraid to feed me, or go out to eat with me. They do not want me to have a reaction, and they do not want to feel responsible for putting my life in danger. My co-workers feel the same. Work lunches, snacks, celebrations, etc. are much harder for everyone. I have started just bringing my lunch when we have special events. It makes everyone sad that they cannot include me. I carry an epi-pen, and everyone I have regular contact with knows where it is.
Prescribed medicines mean I have to call the manufacturer, and hope they will tell me if the medicine has any mammalian products in it as they are not labeled as such. I have also had to change medicines, to be certain that my epi-pen will work without interference from my prescription medicine. I can no longer take NSAIDS, as they now result in me getting hives.
The economic impact AGAS has had on my life is quite significant. Some examples of this are co-pays for medical visits and medicines, sick time, fuel expenses to drive to appointments, and an increase in grocery expenses.
I worry that I will have a medical emergency requiring hospitalization. If I am not conscious, will someone see my medic alert bracelet in time to prevent treatment with medicine containing a mammalian byproduct? What if I need surgery? Will the sutures cause me to have anaphylaxis? Can I safely have dental work done? What is in everything they use in my mouth? Will the medical professionals know and understand the risks and limitations of AGAS?
What about my everyday items? My deodorant, soap, shampoo, laundry detergent? What happens if I touch a table, or a shopping cart that has been handled by someone who has just handled meat? Do I start wearing gloves in public? Or carry wipes to clean every surface I come in contact with? At what point do people start thinking I am crazy, when in fact, all I am trying to do is to get through another day without a reaction? But these are really just the little things. There are bigger questions in this AGAS life I now find myself living.
Since my AGAS diagnosis in 2012, my health issues have been more challenging. I went from a very healthy woman who only had an occasional cold, to someone who now goes to a general practitioner and three specialists multiple times a year. For the last two years I am now being treated for heart arrhythmia, and I have diabetes. My doctor keeps asking me if diabetes runs in my family. It does not. She is mystified as to why I have it. I also suffer from fatigue, lack of energy, and joint pain.
As I connect with more and more AGAS patients, I am finding that it is quite common for AGAS patients to suffer from other health conditions since contracting AGAS. I cannot help but wonder if AGAS is causing these other ailments. Or perhaps AGAS is just another symptom of something bigger that we have all contracted from tick bites.
This spring I hosted an event at my library called “Ticked Off”. My guest speaker was a tick researcher. She talked to the audience about the common ticks in Missouri, the diseases they are believed to carry, and how to protect oneself from tick bites. I had a full house and a wait list. At this event, I met three more AGAS patients. Last week, I met another. I also talked to a Boy Scout Leader who mentioned that they now have to change their cooking menus at camp because they have several boys with AGAS.
It seems to me that there is so much that is not known or understood about the effects of tick pathogens on the human body. How many of these tick-borne diseases are linked? How widespread are they? How fast are they spreading? Do they affect the very safety of the human race? Can people with tick-borne illnesses give blood, or donate organs? Can these diseases be spread from person to person? How are next generations going to be affected if AGAS children cannot have vaccinations against the diseases because mammalian byproducts have been used to make them? I believe that this is just the tip of the iceberg. What I am living with as an AGAS patient is simply just one little piece of a huge unknown puzzle in the tick-borne disease spectrum. What seems obvious to me is that tick-borne illnesses, including AGAS, are rapidly spreading. Tick populations are growing and spreading. Little is known about the diseases they cause in humans. Little is known about how these diseases are related. Little is known about how to treat or cure these diseases. And little is known by the public and medical sectors about how to prevent and treat these diseases and conditions. Clearly, there are many gaps in knowledge and research in these areas.
Thank you for your time. Thank you for listening to my story. I remain hopeful that one day this will just be an interesting little chapter in a life well lived. We all have the power to make a difference. For me, this means telling anyone who will listen to be careful while in “tick country”, and “tick country” is pretty much everywhere! Tick diseases like AGAS and Lyme are truly life changing, but not the kind of life change you would wish for anyone.
Mary Lynn Cady
The biggest limitations to helping the welfare of the public are:
- There are a large number of people with chronic fatigue, chronic pain, cognitive/emotional problems, GI, and other constitutional symptoms that will become well when given certain antibiotics for a very long time. Most of these patients will have neg. test results when testing for “Lyme Disease”. Sam Donta has taught me to think of them as a “Lyme or Lyme-Like Infection”. They have the Symptoms of Lyme Disease, and will only become well with the use of certain long term antibiotics. They do not respond to other treatments, that might be used for people with chronic pain or fatigue, or “post Lyme Syndrome”. The nature of their symptoms require careful observation and questions to establish the positive response to the antibiotics. This is a characteristic that pharmaceutical companies have noticed in the research to determine whether or not their medications will have a positive effect or not, such as with the research to support a positive effect from Lyrica or Cymbalta. They had to redesign the symptom questionnaires to gain positive results.
- Public and Professional educational events given by the CDC and state health agencies are causing fear in clinicians, and discouraging them from trying to use long term antibiotics, to see if they can get a positive response or not. State agencies and the CDC are being critical of clinicians that do this, even though “Lyme Disease” is defined as an infection by one specific species and the testing for that infection is most often misunderstood on how and when to use that to make treatment choices. EG, the two tier testing is recommended, as it is to reduce the odds of false positives in non-endemic areas (no alteration in recommendations for endemic areas). The CDC criteria were designed for use in reporting. The Elisa carries a published false negative rate that can vary from 40 percent to 90 percent. The Western Blot carries a false negative rate of 35 percent. Most education and practice recommendations do not take into account the growing number of “species” of Tick Borne Infections that are not adequately tested for, using current testing techniques. Therefore, thousands or millions of people that could get better with antibiotic use are not being given the opportunity to be given a trial of antibiotics, even though testing to decide who to try to treat is inadequate.
- This problem of many, many people suffering with disabling illness is going to continue until the CDC, state agencies, and medical/clinical boards recognize the limitations of our current research, our limitations in being able to establish the infectious nature of this illness these patients have, and it becomes permissible to use long term antibiotics based on clinical history and physical exam, perhaps supported by lab testing… particularly to make sure other illnesses are not also occurring. It is hard for clinicians and scientists to be public about the limitations of research and guidelines. It must be made “OK” to initiate a trial of treatment, in the face of inadequate response to other interventions or attempts to come up with a diagnosis that results in a good response. Clinicians need to be taught that it is important to keep searching for a method that results in a good response to treatment. Clinicians need to be reminded…. If a treatment doesn’t work… rethink the diagnosis. If known testing and common treatments do not work… rethink the diagnosis and treatment, recognize that testing and our knowledge of what causes illness in humans change every day, every year. If I have a patient that is not improving, and I hear of a treatment that other clinicians say is working… I should rethink the assumptions that I made to develop a treatment plan for that patient. Medicine and what we find works is constantly changing. Absence of Proof is not Proof of Absence (from Dr. Masters). We are supposed to question whether or not research articles are clinically relevant for our patients. If a subset of clinicians are noticing a positive effect from a treatment… we should not be discouraging use of that treatment, we should be asking… why are they noticing this? And, coming up with ways to understand what we are treating and the best way to maximize and promote that treatment, safely. We should not be discouraging use of such antibiotics as Doxycycline, Tetracycline, Clarithromycin, and Hydroxychloroquine… all of which can and have been given safely, long term, for other illnesses… when monitored properly.
- Patients should not fear clinicians. Clinicians should not fear, trying new ideas that might help. Clinicians should not snicker or laugh or criticize other clinicians that seem to be helping the patients they have not been able to help. If a treatment doesn’t work, if a clinician has not been able to help a patient… that clinician should be the clinical scientist we want clinicians to be. Question, why is that patient saying they are improving for the first time in years, and not be defensive and say… “I am glad that you are getting better, but it cannot be the antibiotics”. Yes, I did try many other things, and yes they did not help you, but it cannot be the antibiotics.
Rex G. Carr, MD
Beth Carrison-van der Heide
Thank you for all the work you've done and continue to do, on behalf of the thousands of Americans who have been forever changed by a tick-borne condition.
I ask you to please be mindful of the language used when creating a new model. See page 44 of the last slide in your last meeting and please edit the language on the slide from “TBDs” to “TBC’s”.
Also, please be mindful about the rights regarding discrimination for TBCs, and consider the stories of the Alpha-gal community who have poured their hearts into their emails sent to you. We need your help - all of us. All of the men, women, children, and unborn babies. Let's not forget those that do not have the capacity to speak on their behalf such as the children with disabilities who have this or elderly who are not capable of understanding or researching all that it takes to live an Alpha-gal safe life.
For the record, I was diagnosed with Alpha-gal Syndrome (AGS) and also Lyme Disease. Both went un/mis-diagnosed for 15 years and 3 years respectively. It still baffles me how this could happen when I live 30 minutes outside of the health care capitol of the world and the epi-center of the largest epidemic of the tick-conditions - Lyme Disease. Seriously, how is this allowed to continue?
Over a 15 year period, I was told my AGS symptoms were "probably" anxiety, stress, my laundry detergent (even though I used die-free and color free), psychosomatic, idiopathic and many other incorrect guesses.
I've been tested for Lupus, Cancer, Multiple Sclerosis, Diabetes, but was never sent for allergy testing oddly. I asked but told that wouldn't give me results and that my symptoms were something else. So we kept testing. Knowing my doctor was just basically appeasing me, I just stopped going to the doctor and only mentioned it at my annual exams. It was never taken seriously.
I ultimately made the connection about 6 years ago, that every time I ate any form of pork, I would break out in head-to-toe hives with painful, burning, itchy skin and facial swelling.
My skin is now very sensitive, and my allergist said it is derma dysgraphia. However, it is relatively a non-issue as long as I keep my personal products such as shampoo, soaps, lotions, cosmetics, laundry detergents and all foods and supplements mammal-free. I also have to be mindful of stress and other environmental factors that can alleviate my histamine levels.
This means the products and medications must be labeled vegan to ensure the absence of mammal derived ingredients. If it’s not, I end up covered in red, burning skin, that welts up wherever I’ve scratched myself. I look like I’ve been whipped repeatedly!
We do not cook any mammal meats in our home because any exposed skin will burn and welt up. If I can remove myself from the situation, and wash, the reaction dissipates. Unlike when I ingest mammal, especially pork - that’s when I have gone anaphylactic.
Dairy is tricky. I can eat limited amounts, without rennet or enzymes. If I’ve had a reaction, or its heavy pollen time, like spring, I avoid dairy as it can make me extra “hivey” with a simple touch. IE. I could wisk my hair off to the side of my face and if my hand touched my forehead I’d have a bright red welt for about 30-60 minutes. I constantly looked like an abuse victim. It’s really aweful to alway have to explain it. I rarely enjoy going to the store now because I’m almost always set off after being in the store - food, clothing, mall or department store.
I have had the unfortunate experience of anaphylaxis while at work once. I’m not sure if it was the compilation of the 50 employees, who were wearing colognes and perfumes, or if it was the catered chicken salad sandwich that came off of a mixed tray. I thankfully was blessed with one nurse who had a friend in the Virginia area who had Alpha-gal and said she would immediately get everyone caught up to speed. I don’t think they had a great handle on the situation, but they ended up saving my life after numerous shots and a pharmaceutical cocktail, shot directly into a vein in my hand.
I’ve had to educate from scratch, every physician, dentist, pharmacist, allergist(s), EMS, and even my local health department, each and every time I go in for a visit.
I was asked “Ma’am, Do you even want this procedure?” when I was going in for a routine colonoscopy. It took everything in me not to break down into tears or start yelling. I calmly replied, “Yes, I want to have this procedure. I watched my mother die a painful long 7 death from colon cancer. Her dying wish was that each of her children go as directed by their doctor, every 3-5 years. Besides, I don't want my children to experience that for their mother.” I continued saying, “What I don’t want is to die during a routine preventative procedure”.
This whole situation with Alpha-gal Syndrome is unnecessarily a giant gap in communication across our healthcare system and US Tick-borne Disease research efforts.
Across the 30+ Alpha-gal/Red Meat allergy support groups found online, world wide we have the following trends and concerns:
- Pregnant mothers with severe reactions and sensitivities. (Listening to young mothers cry their hearts out fearing they are going to lose their baby, "this time" is gut wrenching. Hearing a mother share her deepest fears that her baby will be borne with AGS, or that she will "die during labor because somebody used something with Alpha-gal in it" - it's just horrible. Haunting.)
- Babies born with Alpha-gal-like reactions or Mast Cell disorder-like symptoms.
- Children struggling with reactions from school products.
- Children and adults unable to safely take vaccinations since most contain mammal.
- New college students finding themselves in danger due uneducated cafeterias employees.
- Many have developed thyroid issues.
- Many have developed Mast Cell Disorder diagnosis. (Is that because they haven't properly removed all mammal derived products and medications from their life? Or is it truly Mast Cell Disorder - or possibly another condition?
- Cognitive difficulties. Does this effect the brain like Lyme can? Are there variations of the root cause of Alpha-gal?
- We have an aging population becoming diagnosed which is a serious concern since many of the medications and medical devices contain mammal derived ingredients.
- Alpha-Gal (Mammalian Meat) Allergy: Implications for Pharmacists, https://www.pharmacytimes.com/publications/issue/2015/may2015/alpha-gal-mammalian-meat-allergy-implications-for-pharmacists.
- UVa study sees possible link between tick-based red meat allergy and heart disease, https://www.roanoke.com/news/trending/uva-study-sees-possible-link-between-tick-based-red-meat/article_ff110961-738f-55ac-9741-ec105a147eef.html
- Researchers find link between allergen in red meat and heart disease, https://m.medicalxpress.com/news/2018-06-link-allergen-red-meat-heart.html
- Keep in mind histamines are not good for those on blood pressure meds or who have heart disease. Many have to take a histamine, or steroid to live day to day.
- Many have gone untreated for additional tick-borne conditions because they were not tested for them.
- Many with RMSF or the other Lone Star tick related conditions have been sent home without a single mention that they MAY develop an allergy to mammal meats, or possibly dairy. This leaves that individual at risk for anaphylaxis without an epi pen or even a benadryl or other histamine that may save their live. This is simply shameful. We are the UNITED STATES OF AMERICA! We can do better than this!
- Currently, there doesn’t seem to be enough awareness and therefore no standard, well-rounded health care plan for a person diagnosed with Alpha-gal. Shouldn't s/he work with a nutritionist, cardiologist, allergist and possible a counselor? Currently, the individual is sent home and told to avoid red meat. Some physicians tell them to avoid dairy too. The individual often finds himself/herself still reacting because s/he is unaware of the far reaching areas of mammal (soaps, lotions, meds, cross contamination etc.) Then, they find themselves often vitamin deficient, tired, with brain fog, muscle cramping, hair loss, mood swings, etc. Once s/he learns to balance their nutritional needs better, and get some support through supplements those symptoms disappear. But, most of the AGS community has to learn this out through searching the internet - not their physician.
Lastly, as you know, the Asian/Longhorned Tick is now in the US. are you aware that Japan found this tick to also carry Lyme and Alpha-gal. The US doesn’t test for Alpha-gal, yet. Why? Does any other country have the capability? Let's get ahead of this curve as it WILL have a huge social and economical impact if we don't. Keep in mind the effect in endemic areas where children are unable to take vaccinations. Wouldn't this leave that area of our country exposed to diseases that were eradicated previously. IE. Virginia, Arkansas, North Carolina (See map of RMSF which is the only map that hints at the location of the Lone Star tick.)
Your task is daunting. But, this is the UNITED STATES OF AMERICA! We can do better than we have in years past. I'm hopeful your committee will make the changes necessary to help us all.
I am incredibly appreciative of all your recommendation to include "other conditions" within the "US Tick-borne Disease" research.
Thank you for all you are doing. I welcome contact from any member of the Tick-borne Disease Working Group or other organization looking for more information regarding Alpha-gal Syndrome.
Beth Carrison-van der Heide, INHC
Tick-borne Conditions United
I have been diagnosed with Alpha Gal as of late June 2018. Staying healthy and safe is very difficult. Please consider advocating a symbol or some easier way to know if a mammal byproduct is being used in foods, cosmetics, beverages and more importantly in medication. After being diagnosed and put on a medical management routine to help with the hives and breathing issues, only to get worse because of the inactive ingredients in the medication. From the short amount of time I have been dealing with this, the number of people with this life threatening diagnosis is only increasing.
Thank you for your time and consideration.
A rose by any other name would smell as sweet.(1)
But an EM rash?
Erythema Migrans (EM), an expanding red rash at the site of a tick bite is the “hallmark of early Lyme disease”.(2) An EM is commonly referred to as a “bullseye” rash, with a round red ring surrounding a lighter zone. However, only 19% have the bullseye appearance (2); many other presentations are also common, including a solid red rash, a mottled red patch, a blotchy purple/blue and red “angry looking” area, or multiple large spots. EM rashes are typically circular or oval in shape. They can expand from a small spot at the site of a tick bite, to 2-10 inches in diameter (or more) within 3-30 days.
If you have an EM rash, you’ve been infected by Borrelia burgdorferi, the spiral bacteria that causes Lyme disease and you should seek treatment immediately from a physician experienced in Lyme disease.
By law, your Doctor must report EVERY case of LYME DISEASE to the State Health Department. But according to the CDC, only about 10% of the 300,000-400,000 annual Lyme disease cases in the US actually get reported. Why is that?
By any other name, an EM rash isn’t considered a case of Lyme disease. Take for example “cellulitis”.
A practitioner may describe your red rash as any number of different skin conditions including a spider bite (the most common misdiagnosis), an allergic reaction called contact dermatitis, psoriasis, eczema, 5th disease (caused by parvovirus), shingles, poison ivy, a burn mark, flea or chigger bites, or a host of other names for skin conditions, including cellulitis.
Cellulitis is a red skin infection caused by staph or strep bacteria, and the lesion may leak clear or yellow fluid or pus. The treatment for cellulitis is often just “rest” and Tylenol or Ibuprofen. In some cases antibiotics (such as clindamycin, cephalexin or amoxicillin) are prescribed for 7-14 days. (These antibiotics are typically ineffective against Lyme disease.)
Is a misdiagnosis of cellulitis rare? In my opinion, NO! When visiting an Urgent Care physician for a tick bite recently, in a highly endemic area of Minnesota, I was diagnosed with “cellulitis” (but fortunately given 10 days of antibiotics, to cover cellulitis or Lyme, just in case it might be Lyme disease.) Two weeks later, when the red lesion had not cleared, my primary care provider subsequently properly diagnosed the EM rash and extended doxycycline.
In an Emergency Room in Pennsylvania (3), another highly endemic area for Lyme disease, a red rash on the face and neck of a 4 year old girl was recently also diagnosed as “cellulitis”. The following day her condition worsened, with development of high fever and Bell’s Palsy of her face. She was taken to a different emergency room, where she received a proper diagnosis of an EM rash, and given appropriate antibiotic treatment for Lyme disease. One wonders if her Bell’s palsy and other suffering could have been prevented if the diagnosis had been made sooner.
My point is that I’m aware of at least 2 cases of EM in the last month, misdiagnosed as cellulitis instead of Lyme disease. This diagnosis saves the provider from the paperwork required to report a case of Lyme disease, but the misdiagnosis of cellulitis can have serious long-term consequence for the patient, including many years of unnecessary suffering.
According to the Tick Borne Disease Working Group (TBDWG) Chair John Aucott et. al. (2), in a consecutive series of suspected Lyme disease cases from 2002-2007, the diagnosis of erythema migrans (EM) was initially missed in 23% of EM cases. [Dr. Aucott, then defined as a “consulting physician with a high rate of specificity in EM diagnosis” evaluated 165 suspected patients over a 5 year period and diagnosed 101 (1.6 cases per month) with Lyme disease.]
These authors concluded that failure to recognize EM … can lead to missed or delayed diagnosis of Lyme disease, ineffective antibiotic treatment, and the potential for late manifestations. Serious sequelae may result.
Lyme disease can permanently change a person’s health (2).
For misdiagnosed Lyme patients, an EM rash, by any other name, just plain STINKS!
(I suspect the mother, after watching her 4-year old daughter suffer for weeks with Bell’s palsy, unable to swallow properly or close one eye, would agree with me.)
Based on outdated IDSA guidelines (4), standard treatment for an EM rash or Lyme disease, is doxycycline, 100mg twice/day, for 10 to 28 day (3). Even with this standard course of antibiotics, Aucott reports a 36% treatment failure rate (2). Other studies indicate 20 to 50% of patients relapse after the antibiotic runs out, and then go on to develop a wide variety of severely debilitating symptoms that are much harder to treat later.
The International Lyme and Associated Disease Society (ILADS) published alternative evidence-based Lyme treatment guidelines in 2014 based on the latest scientific evidence which recommends more flexible treatment options based on the patient’s clinical response; longer treatment when warranted, and shared decision making between the doctor and Lyme patient. (5)
Based on MyLymeData, Lorraine Johnson, JD, MBA, of Lyme Disease Org. claims that fewer than 10% of patients with persistent Lyme disease choose to be treated under IDSA protocols. She contends that “the IDSA guidelines leave patients without treatment options when short-term therapy fails, as it does in far too many cases”. Given a choice, most Lyme patients choose to be treated by ILADS guidelines.
Whichever treatment protocol is used, if a red rash is dismissed or doesn’t clear up, make sure to get a second opinion. Your life may depend on it!
In a recent TBDWG meeting, Kristen Honey announced that of the 1200+ public comments submitted to the TBDWG, all of the comments (the majority being from Lyme patients or their family members)were reviewed by only a couple of the 65 WG members. Those few people determined that about 20% of the submitted comments were “well cited and very helpful”. The other 80% of comments were “difficult to follow, but patients wanted to be heard”. Yes, Kristen, they did want to be heard. And we want to hear their stories. To disregard 80% of patients written comments because a few members didn’t consider them relevant or important enough to be included in the TBDWG report is a complete disgrace to ALL Lyme patients.
I respectfully request, in the interest of transparency and full disclosure per the TBDWG charter, that ALL PUBLIC COMMENTS be made public, and published on the website.
Minnesota Lyme Advocate
- William Shakespeare, Romeo & Juliet (ll, ii, 1-2)
- Aucott, J, et. al. BMC Infect Dis 2009 Jun 1;9:79. Epub 2009 Jun 1.
- Dorothy Kupcha Leland, “Non-relevant tick bite puts child in hospital”, Touched by Lyme Blog, Lyme Disease, 06 Jul 2018,
- Wormser, et.al, Clin. Inf. Dis, 2006 Nov 1;43(9) 1089-134
- Cameron, Johnson, Maloney. ”Evidence Assessment and Guideline Recommendations in Lyme Disease.” Exp. Rev. Anti-Infective Therapy, 2014 Sept, 12(9): 103-35
To the members of the Tick Borne Disease Working Group:
I was recently encouraged to share my story with you. Thank you for listening.
I grew up in western Wisconsin on a farm. I was often in the woods and fields and I can recall countless tick bites over the years. I was mostly happy and healthy, but this all changed when I was about 10 or 11 years old. I remember having such severe pain in my legs, especially my lower legs, so bad I would cry. I was told it was growing pains. I became easily confused and irritable at times. I developed a very low frustration tolerance and became very angry very easily. I couldn’t explain why exactly. My parents thought it was teen angst beginning a little early. I was plagued by horrible violent dreams that was worse than any movie I had ever been exposed to. At times it would be hard to breathe, like I couldn’t breathe deeply enough to satisfy my lungs; I would yawn repeatedly in an attempt to get more air. These symptoms would cycle: sometimes I would feel good in body and mind, at other times I had a variety of physical and emotional symptoms. When I was taken in for check-ups, I was always given a clean bill of health. Back then we knew nothing about Lyme or Tick Borne Diseases.
Since learning about the physical and psychological manifestations of tick-borne diseases in children, I am convinced that I had acquired tick borne infections as a child. Some of the symptoms I experienced regularly and cyclically are specific to bartonella and babesia. These symptoms re-emerged in force after my most recent tick bite April 2016 in upstate NY.
I had my daughter May 2008. I was sick throughout the whole pregnancy: terrible headaches, nausea, debilitating fatigue, migrating body and joint pain, air hunger, recurring lung infections, and more. My daughter was born mostly healthy but had interesting symptoms that would cycle, including periods of weekly high fevers. I made many positive changes to our diets and lifestyle, and for a few years, our health improved. Then we were exposed to toxic mold for a few years and our health declined again. We moved and discarded nearly all of our belongings. I learned how mold affects the immune system, allowing pathogens & parasites to establish as well as reactivating latent infections.
Some of my symptoms included severe fatigue, sleepiness, weakness, muscle shakes and spasms, muscle twitching, dropping things, slurred speech, stuttering, word-recall issues, easily confused, memory problems, vision disturbances, balance issues, stumbling, and more. My daughter was so tired all the time and would take several long naps during the day. She was forgetting things. She would regularly have high fevers that were difficult to relieve. She started having fainting episodes at age 6. I sought help periodically, but as always, we were given a clean bill of health.
Our health and symptoms seemed to wax and wane. I was always tired and exhausted. I have always been a very motivated, high-energy person. I loved to run and trail ultramarathons are my favorite. To be so tired, fatigued, and unmotivated all the time was very depressing and quite unusual for me. My brain seemed very slow and unresponsive. It was difficult to study and retain information which was also unusual. I’ve always done very well in school and I enjoy learning. I have an insatiable curiosity and am (was) an avid reader. I graduated college in December 2013 with highest honors, and was the graduation speaker. My health really declined after the stress of college was over. I started a small business, but trying to manage it all as a single parent was becoming more difficult due to the continued cognitive issues and fatigue/weakness I was experiencing.
In April 2016 I found a tick embedded in me. At this point I still didn’t know much about Lyme or other tick borne diseases and I wasn’t worried; I have had numerous tick bites over the last 30+ years 7/19/2018 and never had associated any of my symptoms to the tick encounters. Within one week I developed severe symptoms: aches and pains that migrated around the body, especially in my lower legs and feet, headaches and eye pressure, vision disturbances, constant nausea, orthostatic intolerance and balance issues, brain fog, memory lapses, difficulty speaking and word recall. I had to take a couple weeks off of work. I saw a doctor and told her about the tick. She gave me a Lyme test but I wasn’t positive per CDC surveillance criteria, and I didn’t get proper treatment. I didn’t actually even get a Lyme diagnosis until many months later.
In August 2016 my health was becoming critical. I was bedridden most of the month with many symptoms. The local Lyme doctor had a 3-4 month waiting list. Finally on August 31, 2016 I was taken to the local ER. I was completely paralyzed and in excruciating pain from what turned out to be a severe case of rhabdomyolysis and hypokalemia. Due to the extent of the body-wide muscle damage, my kidneys and liver were starting to shut down.
Usually rhabdo causes hyperkalemia but my potassium was dangerously low, even after the extensive muscle damage. The doctors who were treating me in hospital didn’t know what had caused it. Over the next several months they did a multitude of tests, but they could only tell me what my illness was not. I had several Lyme tests but those were not positive by CDC surveillance criteria. Because of the recent embedded tick, I was finally given 28 days of doxycycline but this seemed to only make me worse. I had many ER visits, and many times I needed oral or IV potassium. Tests were abnormal, but never enough to “qualify” for any readily recognized conditions.
In March 2017 I had another random severe episode of rhabdomyolysis that required another weeklong hospitalization. I improved somewhat with herbal treatment over the summer, then declined again. At the end of 2017 I was finally able to start seeing the Lyme doctor regularly. He had suspected bartonella as a primary cause of my severe symptoms but the test had came back negative. I hadn’t done well with antibiotics in the past so we continued with the herbals. I would always start to improve then my health would crash again.
In January 2018 I started having seizures. Some of the doctors thought I was faking seizures and symptoms for attention. When I was in hospital, one doctor even wrote “fictitious illness” and “Munchhausen’s” in my medical file. Another doctor wrote that I was obsessed with my health and abusing dietary supplements. Two months later, I had status epilepticus at the local ER. I slipped into a series of classic grand mal seizure activity that lasted over two hours. Finally the ER staff called for medical transport to the University hospital just over 2 hours away. They sent me by helicopter because I was having difficulty breathing and they thought I might need to be intubated along the way. I “came to” two days later (Monday) and was shocked to find myself so far from home. I didn’t know what had happened. I could only remember going to the ER two days prior. All I can remember is how “off” I had felt that day.
Monday morning, the senior neurologist came to talk to me. He accused me of faking seizures for attention because I did not have a seizure during the 48 hour video EEG. Later another neurologist came in. He acknowledged my seizures were real but insisted they were psychogenic in nature and I needed to see a psychiatrist. He kept insisting that Lyme does not cause seizures (even though it has been documented since the 1990s). After these two interactions, I was so upset and traumatized. This was the third time this year that I discharged from a hospital so upset from the accusations of the doctors that I was crying out of frustration. The staff at this hospital never asked me how I was going to get home, even though I had been brought there by MedFlight.
I had another seizure in April. I didn’t know it was an impending seizure, but I felt so awful like I was about to collapse completely that I went to the closest ER. The nurses were rude and inattentive. The doctor there called the episode “hyperventilation” but I firmly believe it was another seizure that was again not documented properly. I was referred to many specialists over the last 2.5 years, all of whom have been no help. Several have accused me of faking or exaggerating symptoms. One neurologist didn’t want to give me information about possible causes of my progressive symptoms because she “didn’t want to give me any ideas.”
I’ve been hurt and traumatized by the very people who are supposed to help me. Had they taken the seizures seriously in January, maybe we could have avoided the status epilepticus in March. If my original treating doctor from the very beginning had understood that tick borne diseases are stealthy and persistent infections, perhaps I would be doing better now as I would have gotten proper treatment. Instead he ordered hundreds of tests then referred me to a psychiatrist because he didn’t know what else to do for me. I finally started seeing a counselor to help me deal with the psychological damage caused by these doctors.
How could I have ever faked rhabdomyolysis, especially to the severity that it was? How could I have faked a status epilepticus of grand mal seizure activity and fooled the entire ED staff, ambulance and medflight staff? Borellia, bartonella, and ehrlichia have been documented to cause seizures. Bartonella, ehrlichia, and anaplasma have been documented to cause rhabdomyolysis. I had several western blots that showed borellia-specific bands. I took a PCR test from an outside lab that showed positive DNA for borellia, babesia, and ehrlichia. My Lyme doctor made a clinical diagnosis of bartonella. He started treating me for these pathogens with three antibiotics. I was hesitant to take them based on previous experiences but the disease was killing me and I didn’t want to die. I was desperate to heal and this doctor is very experienced in treating Lyme plus he has personal experience with it. Within the first month there was already improvement and it continues slowly. Pain is less severe and I’ve not had any more seizures. I still have such a long way to go. I still struggle daily with debilitating fatigue and weakness. I use all my energy to work part-time, but my income barely covers living expenses let alone full and necessary treatment for myself and my daughter who has been having increasing problems.
My daughter is 10 and was recently diagnosed with Juvenile Arthritis. Her rheumatologist says it’s from long-untreated Lyme. She either had it from birth or contracted it at a very young age, but her early symptoms were attributed then to “normal” childhood illnesses and behaviors. She’s quite restricted in the amount of physical activity her body can handle. She tries to keep up with other kids and pays greatly for it later. She uses a cane to walk on most days. She is embarrassed and depressed by her health issues. She just wants to be able to run and play and have energy like her friends. Instead, she’s tired and in pain and spending an increasing amount of time at doctor and therapy appointments. It’s hard for her to be so restricted physically and cognitively. School is difficult for her. She has a hard time learning and remembering things. She misses school due to sickness and doctor appointments.
She also has started counseling to help her deal with everything. She was with me at the ER both times I had severe rhabdomyolysis. It really scared her and she’s afraid for my health as well as her own. She knows that some of the doctors have accused me of faking symptoms and she is afraid that she’ll also not be believed. She’s had so much physical pain, usually in her lower legs (bartonella) that she sobs, writhes and has even banged her head because her body hurts so terribly. As a mother, this is awful to watch, especially since I know that pain; I’ve experienced it and I know how terrible it feels. Some of the doctors have accused me of faking illness, but really, I fake wellness every day. I still have to work to try to afford all this. I push myself to go to work. I do breath-work and meditation to help control my symptoms as much as possible. I save all my energy to work part time and take care of my daughter. I just don’t have the energy to do anything else. On the weekends I’m so fatigued and in so much pain I can barely get out of bed. I’m thankful that I am able to function as well as I do, even though it’s not enough.
What do we do? This disease complex has stolen our lives from us. Many of the tests and supplements that have been most helpful to us are not covered by insurance. I can barely work part time due to my own symptoms and what little I earn all goes towards living and medical expenses. Now I am taking even more time off to travel to specialists out of town for my daughter. I am forced to file bankruptcy. I just want for us to have our lives back! We want to be active and healthy again!
It seems I hear weekly of friends and neighbors in my area in rural western Wisconsin who now also have Lyme and related infections. Most are prescribed the usual 10-14 days of doxycycline. Most do not get better with this treatment. It is ineffective, like the current testing.
We desperately need better testing and treatment for tick borne diseases! We need doctors who are better-educated about the many manifestations of TBD. We need them to believe us instead of accuse and dismiss us. We need medical staff who have compassion and empathy. We need insurance companies to cover our treatments! We need more research funding for scientists like Dr Eva Sapi who are discovering many things about Lyme and TBDs that can be helpful in better understanding and treating the diseases. We need more doctors like Richard Horowitz who understand that TBDs are complex, stealthy, and persistent infections, and in order to heal, we need an integrated, multi-faceted approach to treatment. We need enforceable protection for our doctors who are brave enough to risk diagnosing and treating us. We cannot wait. People, adults and children, are suffering and dying every day from this brutal disease. It is a relentless nightmare and we need help to heal.
Thank you for listening.
In 1985, I was helping a friend do some land surveying in central Texas. When I got back to my room in the evening and went to take a shower I found myself covered with small ticks from head to toes, many were attached.
Approximately 2-3 weeks later I started to have severe stomach cramps and hives usually in the late evenings. After many weeks and trips to emergency rooms I determined this happened about 3-5 hours after eating. When I would mention the ticks the medical professionals would literally laugh at me. My doctor sent me to an allergist and I got no definitive answer.
Over the next 12-18 months my husband and I finally came to the conclusion that the reactions occurred after consuming beef, pork or venison.
I finally felt somewhat vindicated when articles started appearing from the research being done at several universities.
It's now been about 3 years since my last visit to an ER after consuming some vegetables cooked with a pork roast.
I now see an allergist who is located about 225 miles away. My blood tests still show positive and it has now been 33 years. I remain vigilant what and where I eat. I also carry an epi-pen with me daily.
I pray that someday this will go away and that the medical community will become more knowledgeable about this allergy. I still remember being ridiculed by many people, they still don't understand.
Recommended Actions to Congress and Federal Agencies to Address Tick Borne Disease
Submitted by: Sherrill Franklin / Lyme Research Initiative / West Grove, PA
ENFORCEMENT OF EXISTING LAWS
Enforce Existing Laws To Protect Workers with Tick Borne Diseases
Enforce existing laws protecting workers from job discrimination due to Lyme and tick borne diseases by providing reasonable accommodation under the Americans With Disability Act.
Enforce Existing Laws To Protect Students with Tick Borne Diseases
The special needs of students with tick-borne disease are sometimes not addressed or accommodated within the classroom setting.
Enforce existing laws that guarantee a Free and Appropriate Education (FAPE) for students with tick borne disease under the Individuals with Disabilities Education Act (IDEA).
Enact Legislation to Guarantee Insurance Coverage to Protect Patient Rights
With no other illness are patients routinely dismissed and expected to find help on their own for a serious disease outside of the medical insurance system. This is a costly and time-consuming process for patients.
Massachusetts developed a Lyme disease treatment coverage insurance mandate that could serve as a model for coverage. This legislation mandates insurance coverage for treatments based on clinical diagnoses and criteria, when made by licensed providers.
Use other existing state models for legislation. For example: In Maine, (1) legislation passed (LD 1709) requiring a report to be written every year for public awareness with the status of tick-borne disease surveillance and tick-borne disease case counts every year; (2) legislation passed (LD 597) acknowledging the difficulty in diagnosing and treating Lyme disease along with information on risk of long term antibiotic therapy; (3) legislation passed (LD422) to improve access to treatment for Lyme disease, allowing a medical provider to prescribe, administer, or dispense long-term antibiotic therapy to eliminate infection or control a patient's symptoms.
The following website provides a list of states that have patient and provider legislative concerning diagnosing and treating Lyme and tick-borne disease: https://www.lymediseaseassociation.org/govt/state-legislation/state-activities-test
Enact Patient Information Disclosure Legislation When Tests are Not Reliable
Adapt Maryland's "Patient Information Disclosure Act" as a model for legislation. This act ensures that patients are notified when any diagnostic test is performed that lacks a high level of reliability (not necessarily restricted to Lyme testing).
Enact Legislation to Protect Physicians Diagnosing and Treating Tick Borne Diseases
Medical providers have faced disciplinary action and fines from state licensing boards because they choose to determine the direction of their patients' treatment based on individual circumstances and treatment responses.
Physician protection laws afford licensed providers the right to diagnose and treat Lyme disease according to clinical criteria.
RESOURCES, EDUCATION AND DATA COLLECTION
Establish Centers of Excellence That Consider Views of All Stakeholders
In establishing Centers of Excellence it is critical that the needs and interests of all stakeholders are considered.
Warn Public of Dangers of Tick Borne Disease through Public Service Announcements
While the CDC provides public service announcements for everything from influenza to the dangers of carbon monoxide poisoning, public service announcements for tick borne disease are noticeably absent. A CDC/HHS public service announcement program to warn the public of the dangers from tick bites is critical to preventing the expansion of disease.
Need for Behavioral Health Resources – Coordinated, Interdisciplinary Resources for Patients with Tick Borne Disease
Tick borne diseases that enter the nervous system can cause a wide variety of both medical and neuro-psychiatric symptoms, including cognitive dysfunction, sensory sensitivities, mood disturbances, infection-induced autoimmune encephalopathy.
This interplay is complex and requires an interdisciplinary medical team for appropriate care and accommodation in workplace and school settings.
Implement Federal Demographic Reporting Through Medical History Forms
Include a Lyme/tick-borne disease checkbox on all medical history forms within federal healthcare institutions to gather accurate data about prevalence, health impact, and cost of tick-borne diseases.
Medical history forms within government healthcare institutions and programs include but are not limited to: Veterans Health Administration (VHA), National Cancer Institute (NCI) Hospitals, Other NIH health facilities, Federally-funded Health Care Centers of Excellence, Medicare, Medicaid, State Children's Health Insurance Program (SCHIP), Indian Health Service (IHS), CHAMPUS, DOD, TRICARE.
Establish Performance Indicators for Tick Borne Disease
Performance indicators provide information to monitor performance, measure achievement and determine accountability. A quantitative metric can be used to provide data on the quality of an activity, project or program. Other categories include: performance, achievement and accountability indicators.
As cases of tick borne diseases increase every year, carefully crafted performance indicators track the effectiveness of current methods so that better approaches and techniques can be developed and federal agencies are held accountable.
RESEARCH FUNDING AND PRIORITIES
Increase Funding for Tick Borne Disease Research through Department of Defense Congressionally Directed Medical Research Program (DOD CDMRP)
Research grants through the DOD CDMRP benefit both the military and civilian populations. Patient stakeholders are included on grant panels to assure that patient research funding priorities are represented.
CDMRP awards for tick-borne disease research promote a wide range of research from basic through translational, including studies in animals and humans. These awards fund rigorous, high-impact studies that have the potential to significantly improve diagnosis, treatment and prevention of tick-borne diseases.
Increase Funding Levels for Tick Borne Disease Research through HHS
Increase tick borne disease research grant opportunities through HHS. Reflect funding priorities commensurate with the burden of disease.
Reflect Research Priorities of Patients Within CDC and HHS Grant Awards
Patient research priorities should include the development of better diagnostics.
In addition, there should be systematic and detailed investigations into the underlying physiology of the causes of chronic/persistent Lyme symptoms – specifically those that occur or persist either after initial antibiotic treatment or that occur in patients who did not receive a diagnosis and/or treatment for acute/early Lyme disease.
This research should investigate autoimmunity as well as the possibility of persistence.
These priorities have been largely ignored, or, when grant panels have recommended these research projects for grant awards, they have been overridden and denied funding.
Hold Congressional Hearings To Identify and Correct the Public Health Policies and Human Rights Issues Blocking Patients from Receiving Diagnosis and Treatment for Tick Borne Diseases
Legislative oversight and investigative hearings or some combination offer an important method to correct the public health and human rights issues facing tick-borne disease patients.
Legislative Hearings provide a forum where facts and opinions from witnesses and stakeholders from varied backgrounds are presented prior to considering legislation. Initiate Investigative Hearings to provide a legislative remedy to address problems especially if there is a suspicion of wrongdoing on the part of public officials.
Hold Oversight Hearings to review or study current law, issues and activities while focusing on the quality of federal tick borne disease programs. It is essential that existing government policy and operations for tick borne disease is scrutinized for efficiency, economy and effectiveness.
Gina Franklin Workman
I have suffered with the symptoms of Alpha-Gal allergy since 1978, when I was 10 years old. At that time, I was a young girl, growing up in the woods of south central Arkansas. I loved playing outside and could often be found climbing trees, and playing in the woods. I suspect this was how I came into contact with a tick that would forever change my life. Shockingly, it took 35 years before I was formally diagnosed with Alpha-Gal. In 2013, my daughter read an article online about Alpha-Gal allergy and said to me, "Mom, I think this is what you have." She was right. The article mentioned Dr. Tina Hatley-Merritt, from Bentonville, Arkansas. I made an appointment with Dr. Hatley-Merritt and a blood test at long last, confirmed my diagnosis.
My reaction symptoms vary from one attack to the next. I have had light reactions of itchy hives over part of my body from things like eating food that was cooked in cast iron cookware, where red meat had been previously cooked. I have had a number of more serious reactions where I broke out in hives that started out pinpoint size and grew to be red and raised, almost like a burn, all over my body, with the worst itch imaginable. I have also had my lips swell very large, my eyes swell shut and have had difficulty breathing. When I was a child, I was given Benadryl. 25 mg. After a few years, this did not work as well so I was then prescribed Atarax. 25 mg. I have made numerous trips to the ER over the years, when I have had anaphylactic reactions. I now carry 2 Epi-pens with me everywhere I go. Usually, the first indication that an allergy attack is imminent is I have a strange tingling on my scalp. Unlike some who have Alpha-Gal, I am able to eat dairy products. However, sometimes, this is followed by gastro-intestinal upset, like diarrhea. I have not reacted every time I eat red meat. Typically, I would have a reaction about once every 6-9 months. Once I knew what I was truly allergic to, I stopped eating all red meat. It is so hard for me to believe that this allergy has been around so long, yet it was only given a name in 2006.
I wanted to share my story in hopes that it may help in some way to learn more about this condition and to help make the public more aware about it.
Gina Franklin Workman
I have Alpha-gal allergy. This has changed my life in so many ways I hope I can try and relate them all to you so we can get more help.
It happened in 2013 when no one knew much about the allergy. I've never been allergic to anything in my life before that, and now it seems like I'm allergic to so many things!!!
I was in bed sleeping when I woke up itching and hives from head to toe. My throat was closing up and I called 911. I lived out on a rural road 20 mins from an hospital. They couldn't find my house, my throat was swelling and couldn't talk to the operator. Finally they show up take me in and didn't know why I was having this reaction. So got epinephrine and bendryl and sent home.
The next time it happened it was at work and I drove to a clinic nearby. Again ambulance and trip to E.R. They still had no clue. Went to an allergist she did skin tests but never found out why. Then one day I got bit by another tick and I looked up what kind it was, and it was a lone star tick. I lived in Holden Missouri. It also had an article about this tick could give you an allergy to mammals. So I got the blood test and that's what it was. So, I diagnosed myself! Now 5 years later my doctors and a lot of friends and family think this is all in my head! I've had heart problems, got a pacemaker 3 years ago, gut issues, allergic to every bug bite I get, tired, joint aches, etc. I never go out to eat unless it's a chicken or fish place, no family dinners, read every food label EVERY TIME I buy something, because they change ingredients on me. Now need surgery, and this is the worst nightmare I face, THE HOSPITALS! They don't even put on a red allergy bracelet unless I demand it. The anesthesiologist is a SUPER RUDE person when I call to make sure no mammal products are going to be used tomorrow. She refers me to the pharmacy which of course never calls me back. After my pacemaker surgery they tried to inject me with heparin. I had to stop the nurse....which is made from pigs, they just don't know enough about our allergy, or again think it's all in our heads. I can control what I eat and use on my body, but the hospital staff is my biggest worry. So I could go on and on but I hope you can get this allergy recognized as LIFE THREATENING as a peanut or penicillin allergy.
Good afternoon Ladies and Gentlemen,
Thank you for allowing me to inform you of my situation living with Lyme disease and the Mammallian allergy.
I live in Culpeper county Virginia. On May 29, 2011, I went horseback riding at the Manassas Battlefield with my mother-in-law. I rode for approximately 5 hours, dismounted, checked my horse, who was covered in ticks, in fact, I took 22 ticks off my horse and proceeded to check my body. I found three lone star ticks on my left foot. The week before I had been in my yard working and took a brown deer tick out of my head, like I have so many times over the years living in Culpeper county.
Fast forward 3 weeks, I woke up feeling a little warm and for 3 days I had a low-grade temperature right around a hundred. I questiond what the issue was with my body, but then it disappeared, I didn't think about it any further.
On July 1st I was exercising at my gym and felt like I was going to pass out, I made it to a chair and collapsed. I was in and out of consciousness, I was not able to speak or think as I came to. I would try to talk, I couldn’t articulate words. Fortunately, everyone at the gym knows me so they knew something was wrong and called 911. I was able to get a few words out "call my daughter Diane" but I was so out of it I said the wrong name. My daughter's name is Danielle. The first thing I noticed that I could barely feel my pulse and I had just come out of a cardio class where my heart beat should be about 130-140 beats per minute. I was shaking all over and in and out of consciousness. The rescue squad arrived 7 minutes later. I was starting to feel anxious because I had no idea what was going on. When they arrived and they took my blood pressure it was normal for me 110 / 65, mind you, I was anxious at this point, it should have been higher. A few minutes later they took it again, it was 180 over 90. They took me to the emergency room. I spent hours there so they could run tests on my heart and do all the normal blood work that's required when you come into the emergency room. All my test came out normal and they attributed my episode to anxiety. I'm familiar with anxiety and this was not an anxiety attack. I did get anxious when my heart rate dropped so low but it returned to normal at the hospital after a period of time. I left the hospital with printed papers talking about anxiety and seeing a doctor to get on low doses of anti-anxiety medication. I did not think that was the answer but I continued on my merry way.
A week later I had another attack and I passed out. When I came to again I noted I could not feel my pulse; it was very weak. This time the Rescue Squad was called and they arrived again to find me in the same condition, normal pulse rate a little sweaty and as we got close to the hospital my heart rate went up again. I arrived at the hospital for a second time and they ran more tests on my heart. Same result, they couldn't find anything wrong with me. I had no idea what was going on with me at this point but in time I would find out it was tick related issues.
As time progressed I was very weak, I had hives all over my body. I had trouble breathing. I felt like this heavyweight was on me all the time. I called my general practitioner and asked him to do a Lyme's test on me. He did a regular Lyme's test which came out negative. As time progressed I got weaker and weaker.
One Saturday morning I woke up and every joint in my body was aching, I literally crawled into the shower. I felt like I'd aged 40 years overnight. I called the doctor again and asked him to do another Lyme's test this one came out negative but he put me on doxycycline anyway. I didn't get better I got worse I went from being a very active person who worked out 2 hours 5 days a week to laying around on the couch or the bed, not able to stand up to cook. I couldn't walk 20 feet without having to sit down and rest. I started getting very forgetful, and I had periods of time where I felt like I was falling over for just a split second. I went back to the doctor for another Lyme test, this one came out negative. Over the next few weeks my symptoms intensified, my children were terrified, they have never seen their mother so weak unable to work out, unable to work in the yard. I stopped horseback riding, hiking and swimming. I had become a couch potato.
I wrote down all my symptoms and sent them to my aunt's doctor. Two weeks later I arrived for my appointment. He told me he knew what I had the moment I sat down. He read an article in the Post paper describing a man's reactions to a meat allergy from a tick bite, known as mammalian allergy.
He told me the solution was not to eat meat from a mammal. Confused, I left and took him serious because it was the only answer I had. I didn't pass out anymore after that time but I still was very weak, had brain fog, I was covered in hives and at this point I was wheezing almost every day. He sent me to an infectious disease doctor. They ran tests and told me I could have lupus, I tested partially positive for lupus. I was tested again 3 weeks later it came back negative. I was then sent to a rheumatologist, I could possibly have RA, I tested negative. I asked them to test me for Lyme disease, it came back negative. I went to an allergist in town and they ran all the allergy test that are standard for food allergies. I had never had allergies in my life and now I was allergic to 27 items on the list, including beef and pork.
I returned to my aunt’s doctor and explained to him that I had several Lyme test that came out negative is there any other test that he can do to verify I have Lyme disease because I had all the symptoms except I never had a bullseye that was visible to me or my family.
He said he can try a Western blot test, which would test me for the antibodies, I came out positive. Finally getting answers was a huge relief. I have the Mammallian allergy and I have Lyme disease. By this point in time somebody finally came out with a test for the Mamallian allergy called the alpha-gal test. I was tested and .35 and above means you are allergic to meat, my numbers were 8.76 which causes my body to go into delayed anaphylaxis. My window of time is 15 hours after I ingest a piece of meat. I now had answers for the times that I ended up in the emergency room. I now had answers for why my body was turning on me, why a healthy energetic 46 year old could be spending most of her days laying around instead of outside doing the things that she loved. My Lyme's disease was treated with Ciprofloxacin, a different drug all together from doxycycline. 12 hours after taking this antibiotic I felt as if a veil of weight was lifted off my body. 24 hours later my mind started to clear my pain started to go away. I called the doctor to let him know that this was the best I've felt in months. He said normally this is not used to treat Lyme disease but if it was helping he would keep me on it. I stayed on it for a month. I improved over that month but it took a year-and-a-half for the neurological issues to go away to the point where I didn't feel like I was falling over every so often. My stamina increased over time. I continued to have hives on my upper body for two and a half years.
I had an appointment with Dr. Platts Mill at UVA in Charlottesville, he is one of the doctors that helped discover the Mammalian allergy. I gave him a list of my symptoms and talked to him for an hour. He offered recommendations to help with my symptoms but he had not dealt with someone who had Lyme disease and the Mammalian allergy before. I spent the next 3 years making sure my life was balanced. I ate healthy, I slept 8 hours a night, I meditated and went to church, I exercised for 1 hour 5 days a week.
Today I am 7 years out and I still get my alpha-gal test done yearly. My numbers are at 4.46 as of March 2018. I don't test for Lyme disease anymore but I have arthritis-like pain in my right foot and right hand. I'm still unable to eat meat from a mammal and don't know if I ever will be able to without going into delayed anaphylaxis.
Please take into consideration there are more people like me out there whose lives have come to a halt. They have no idea a small insect has changed their future due to a disease or an allergy they now have.
More research needs to be done, more drugs have to be offered other than doxycycline for relief of Lyme disease.
The Lyme disease test for humans needs to be improved, there are too many false negatives. If I didn't research all my avenues and go to 8 different doctors, I would not be where I am today. I'm 53 years old I work out 4 days a week sometimes two hours a day. I have a senior in high school, a two year old granddaughter, a farm with chickens, rabbits, and a horse. I take care of my neighbor's pool and I swim 3 to 4 times a week. I'm one of the lucky ones. There are so many more people out there that have no idea what's wrong with them.
Please consider better testing so the people out there who have this allergy or this disease can get answers and get healed to live normal lives again.
Thank you for your time.
I am writing to give my account of being diagnosed with Alpha Galactose Allergy, related to a tick bite, I received in May 2016.
I was diagnosed in April 2018. I had been seen by 6 different doctors in 6 different specialties before I was diagnosed. This process began in 2017after suffering for some years with chronic abdominal pain, repeated infections, weakness and general fatigue. For a few years I had been awakening in the night with sweats, shortness of breath, rapid heartbeat, feelings of suffocating. I had decided I had to find out what was wrong with me. I tried my general practitioner, who referred me to rheumatology, who did labs and found no evidence of a autoimmune disorder. At this time I had a severe rash, hives, itching. I then went to another rheumatologist, had multiple tests, CT scan, no diagnosis. This person actually tested me for Alpha Gal but not IGE so again, nothing. I then went to an allergist who gave me the wrong diagnosis of scabies, I am a nurse and knew this was wrong but used the med anyway which did nothing. Then I went to dermatology, who did labs and a punch biopsy and gave me the diagnosis of vasculitis, non-specific. This rash had now lasted for 6 weeks. I went back to the allergist who finally did the correct test in April 2018, because I told her I felt like I was going to die the prior night with stomach pain. shortness of breath and suffocating feelings. She asked what I had eaten and told her pork. 2 weeks later she sends me the results of Alpha Galactose allergy and tells me "not to eat any furry animals".
I am telling you this so you can understand how glib and nonchalant doctors who do not take this allergy seriously treat their patients.
This entails so much more than a food allergy. I have had food allergies for many years. I am used to diet restrictions. This is much more than this. I had to change my medications due to animal by-products, they are in so many things. I became so reactive to foods I normally could eat. I had to take mega doses of antihistamines, inhalers, steroids at one time. I had to change all my personal care products.
It is past time to take this allergy seriously and educate the doctors so people can be diagnosed in a timely manner. It is also critical that the government of our country takes this tick borne disease seriously and make a decision to educate people and provide places people can educate themselves.
Without the support groups and persons who have this Tick sickness, many of us would still be ignorant and having anaphylaxis and going to multiple doctors and being misdiagnosed. There are so many areas that need addressing regarding Alpha Galactose Allergy. The experts, and there are some dedicated doctors and persons who are working in the groups, who are working to help people know what needs to happen to find a way to control the ticks that cause this and treatment for people who are suffering from this.
Thank you for accepting my story. I have all my documents from my tests and doctor visits with dates and labs and diagnoses and am happy to share them, if they would be of help to you in understanding what we are going through.
Sanford, North Carolina
Annual Lyme disease costs may exceed $75 billion
The analysis in this report draws heavily on the principles underlying the Zhang study and the Johns Hopkins big data insurance study by Adrion and Aucott. In addition, it includes information from MyLymeData, a patient registry launched by LymeDisease.org and two big data Lyme patient surveys published in peer reviewed publications regarding access to care and healthcare utilization by Lyme disease patients. Finally, it considers the incidence Lyme disease and the prevalence of persistent or chronic Lyme disease and recommends actions that could reduce the cost and burden of the disease. Additional information on these issues is contained in Attachment A of this report.
Dr. Zhang of the Centers for Disease Control (CDC) estimated that in 2002, the annual cost of Lyme disease in the US was $203 million. (1) The Zhang study focused on capturing all societal costs regardless of who made payment for the costs. By 2012, those annual costs likely exceeded $3.1 billion. (The increased cost reflects the CDC revision of case numbers from 30,000 to 300,000 and adjustments for inflation.) The Zhang study further allocated this cost between direct medical costs, indirect medical costs (e.g. additional out of pocket medications), other costs (e.g. travel), and loss of productivity (lost work days). These costs were determined by a review of medical records and patient responses to a questionnaire. The results were provided for both early and late/chronic Lyme disease.
Table 1. Zhang 1997-1998 - Lyme Disease (LD) Cost per Patient (adjusted to 2000 dollars in study)
|Types of Costs||Early LD Cost (%)||Late/Chronic LD Cost (%)|
|Direct medical costs||$801 (60%)||$1,872 (12%)|
|Indirect medical costs||$259 (20%)||$1,134 (6%)|
|Non-medical costs||$52 (4%)||$5,109 (32%)|
|Productivity loss||$198 (15%)||$8,785 (54%)|
A more recent Johns Hopkins study by Adrion, using a big data insurance base found direct medical costs to be $2,968 higher for patients with Lyme disease.(2) Adrion’s study identified patients who had a Lyme disease diagnostic code coupled with antibiotic treatment, but eliminated all patients who had a Lyme diagnostic point at any point in the prior 6-month washout period. This means that her study was largely confined to patients with acute Lyme disease. Using the Centers for Disease Control estimates that Lyme disease cases may range from 240,000 to 440,000 per year, she estimated Lyme disease direct medical costs to be as high as $1.3 billion a year. Assuming the same indirect medical costs, non-medical cost and productivity loss percentages as Zhang, would increase the annual cost of early Lyme disease in her study by 39% to $4,125 per patient or $1.8 billion a year when applied to CDC case estimates.
One of the limitations of using an insurance data base is that it only includes insurance claims. Data from the MyLymeData patient registry indicates that the healthcare providers of 50% of those enrolled do not accept insurance. Those enrolled in MyLymeData are more likely to have chronic or persistent Lyme disease and do not reflect the full spectrum of the disease. If the costs of those whose medical care is not covered by insurance was included in the Adrion study, the annual cost of illness would be higher.
In addition to the costs associated with acute illness, the costs of persistent or chronic Lyme disease is estimated by Zhang to be 12 times higher than the costs associated with early disease. The majority of this cost (86%) is attributable to non-medical cost associated with late/chronic disease and loss of productivity. Accordingly, costs associated with late/chronic Lyme disease should be far higher than those indicated in the Adrion study (which largely reflected early illness and which focuses exclusively on direct medical costs). Using Adrion’s direct medical cost estimates and Zhang’s inflation adjusted other costs, the total cost of illness for those with late/chronic Lyme disease, is reflected in the table below:
Table 2: Late Stage Lyme disease Cost of Illness per Patient
|Types of Costs||Cost|
|Direct medical costs (Adrion)||$2,968|
|Indirect medical costs (Zhang inflation adjustment 2000-2018)||$1,655|
|Non-medical costs (Zhang inflation adjustment 2000-2018)||$7,459|
|Productivity loss (Zhang inflation adjustment 2000-2018)||$12,826|
Prevalence reflects the number of patients who contract Lyme disease and remain ill over time. As such, it is a cumulative number that grows annually and is diminished only by death or cure. The number of patients with chronic or persistent Lyme disease is unknown, but is based on the stage of the disease at diagnosis and the percentage of treatment failures associated with that stage.
Treatment failure rates for early Lyme disease range from 10% to 48% depending on the treatment, duration of treatment, and definition of treatment success. Low treatment failure rates (10-20%) likely reflect patients who were diagnosed with acute illness, treated early, and failed treatment based on objective findings rather than symptoms characteristic of persistent or chronic Lyme disease (e.g. fatigue, pain, arthralgia). Even with early diagnosis and treatment, a study by Aucott found that at six months 36% of patients developed new-onset fatigue, 20% widespread pain, and 45% neurocognitive difficulties.(3) A rigorous GRADE analysis of early treatment studies that defined treatment success as a return to pre-morbidity baseline, found treatment failures ranging from 15-48%.(4)
The percentage of patients not diagnosed early is also unknown, although one study suggests that 40% of patients are likely not diagnosed early.(5) Treatment failure rates are higher for those diagnosed late and for those with the persistent form of the disease. Treatment failure estimates in those with late/chronic Lyme disease range from 34-53% using broad demographic data with follow-up periods extending out to 4.5 years.(6-9) These estimates of treatment failure rates associated with early and delayed diagnosis suggest that the prevalence range of persistent or chronic Lyme disease is between 35-50% of those who contract Lyme disease.
As noted above, prevalence is the number of people who contract Lyme disease and remain ill. These patients have chronic or persistent Lyme disease. Estimates of prevalence start with the disease incidence rate (those who contract a disease) and are based on assumptions of the percentage who remain ill after treatment (based on treatment failure rates.) The length of time patients remain ill is unknown, with one big data study indicating that over 50% remain ill for 10 or more years.(10) Since 10 years was the longest period indicated in the question, it is possible that the length of time for a substantial percentage of patients may exceed 10, 20 or 30 years (perhaps lasting a lifetime).
Table 3 below is based on the CDC 300,000 annual case estimate and treatment failure rates ranging from 10% to 50% over different years of illness duration to estimate the number of Lyme patients who develop late/chronic Lyme disease. Assuming that between 35 and 50% remain ill after treatment and the duration of their illness lasts between 10 and 20 years, persistent Lyme disease would range from 1 to 3 million cases. This would place the total annual cost of late/chronic based on Table 2 ($24,908) roughly between $25 and $75 billion dollars. When the total costs (direct medical, indirect medical, non-medical, and loss of productivity costs) of acute ($1.8 billion) and late/chronic Lyme disease are combined, they aggregate to between $26.8 billion to $76.8 billion.
Table 3. Number of Late/Chronic Lyme Patients based on % Who Remain Ill After Treatment
Clearly, we need better treatments to prevent those who are diagnosed early from progressing to persistent Lyme disease. We also need better treatments for those who are not diagnosed until they have late stage Lyme disease. Patients with Lyme disease incur significant medical costs, impairment in their ability to work, increased utilization of healthcare services, and greater out of pocket medical costs than the general population.
A summary of the factors considered in this assessment is reflected in Table 4 below:
Table 4. Research Study or Estimate for Annual Cost of Illness for Lyme Disease
|Factors Considered in Assessment||Lyme Disease Annual Cost|
|CDC Zhang study (36%: direct medical; 64%: indirect medical, other & loss of productivity costs)||$203 million|
|CDC Zhang study adjusted for CDC new estimate of 300,000 cases and inflation||$3.1 billion|
|Johns Hopkins Adrion (early LD) big data insurance direct medical costs only||$1.3 billion|
|Johns Hopkins Adrion (early LD) adjusted to include 64% indirect medical & loss of productivity costs||$3.6 billion|
|Estimated total cost of late/chronic Lyme disease (CDC Zhang inflation adjusted using Adrion direct costs)||$25-75 billion|
|Estimated total annual combined cost of acute and late/chronic Lyme disease||$26.8-76.8 billion|
- Zhang, X., et al., Economic impact of Lyme disease. Emerg Infect Dis, 2006. 12(4): p. 653-60.
- Adrion, E.R., et al., Health care costs, utilization and patterns of care following Lyme disease. PLoS ONE, 2015. 10(2): p. e0116767.
- Aucott, J.N., et al., Post-treatment Lyme disease syndrome symptomatology and the impact on life functioning: is there something here? Qual Life Res, 2013. 22(1): p. 75-84.
- Cameron, D.J., L.B. Johnson, and E.L. Maloney, 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. 12(9): p. 1103-35.
- Hirsch, A.G., et al., Obstacles to diagnosis and treatment of Lyme disease in the USA: a qualitative study. BMJ Open, 2018. 8(6): p. e021367.
- Asch, E.S., et al., Lyme disease: an infectious and postinfectious syndrome. J Rheumatol, 1994. 21(3): p. 454-61.
- Shadick, N.A., et al., Musculoskeletal and neurologic outcomes in patients with previously treated Lyme disease. Ann Intern Med, 1999. 131(12): p. 919-26.
- Shadick, N.A., et al., The long-term clinical outcomes of Lyme disease. A population-based retrospective cohort study. Ann Intern Med, 1994. 121(8): p. 560-7.
- Treib, J., et al., Clinical and serologic follow-up in patients with neuroborreliosis. Neurology, 1998. 51(5): p. 1489-91.
- Johnson, L., et al. Severity of chronic Lyme disease compared to other chronic conditions: a quality of life survey. PeerJ, 2014. 2, e322 DOI: 10.7717/peerj.322.
- McGinty, J., Lyme Disease: An Even Bigger Threat Than You Think: A look at why cases of the tick-borne illness are undercounted, in Wall Street Journal. June 22, 2018.
Tick Borne Disease Working Group:
I was bitten in June 2015 by a Lone Star tick in Virginia. I became ill within a few days of the bite and was diagnosed with Lyme Disease, Alpha Gal Mammalian Meat Allergy (AGS), Babesia, and several other active infections and viruses within 2-3 months following the tick bite. Prior to this, I was a healthy, intelligent 44-year-old single mother with two teenage boys working at a very challenging job as an Environmental Manager at a Power Plant.
I was tested for and diagnosed with the following active infections/illnesses/conditions within 2-3 months after the tick bite: Epstein-Barr Virus, Candida, Mycoplasma Pneumonia, MTHFR Heterozygous Gene mutation, and Leaky Gut. Since then, I have also been diagnosed with MARCoNS, Mold Illness, Multiple Chemical Sensitivities (MCS), Chronic Fatigue Syndrome (CFS), EMF sensitivity, Sleep Apnea, Neurodegeneration, autoimmune encephalitis, an unknown autoimmune disorder, and thyroid disorder.
Now, three years later, I have no job and am still trying to regain my health after contracting multiple tick-borne illnesses from one tick bite and watched my health decline rapidly. I am writing this to show even with prompt treatment, Lyme disease and coinfections can persist and worsen and lead to health decline over time despite years of treatment, including antibiotics, antivirals, antiparasitics, nutritional supplements, and alternative treatments, most of which were not covered by insurance. I literally tried every prescription antibiotic available to me that was covered by insurance, many with dangerous side effects. Many pharmaceutical drugs were denied by insurance, including IV antibiotics. I tried non-traditional treatments as well and got more success with alternative treatments. I have literally spent virtually my entire savings on trying to heal from these illnesses.
I do not have the time or energy to fully address all the issues of concern on each of the subcommittees, but I wish to share my invaluable personal experience over the last three years. If my words seem out of order, please understand my brain is still healing from these conditions.
A few things to note that I encountered during this period, and while this may sound horrific, this is unfortunately the reality that Lyme patients face:
- My PCP refused to test me for lyme disease initially because I did not have “typical” symptoms and no bullseye, hence delay in treatment.
- My PCP was unaware of alpha-gal mammalian meat allergy and didn’t think my sudden meat allergy was related to the tick bite.
- After 2 follow up visits when 30 days of doxycycline did not “cure” me, my PCP washed their hands of me and suggested I seek psychological help.
- My PCP did not think Lyme disease could cause “brain fog”, or anxiety, which were two of my worst symptoms, and is very common among tick borne illnesses. Hence, they essentially did not believe me and offered no further help. They scoffed at the idea of going to a “Lyme Literate MD”.
- A neurologist told me after viewing my MRI and examining me, that there is no such thing as chronic lyme disease, that I may have “post treatment lyme syndrome”, and that all my symptoms (neurological problems) will gradually go away and were caused by being sick for so long. This is in 2017, 2 years after tick bite and continuous treatment. Hmmm….
- It should be clearly known that many doctors shy away from treating patients that even suspect they have lyme disease. They don’t even want to open that can of worms. I can’t tell you how many doctors I have been to that are not Lyme Literate, that scoffed at my symptoms and told me there’s no such thing as chronic lyme disease. Well, I really don’t care what you call it at this point. The evidence is clear in my medical records of my many symptoms and conditions that were triggered after the tick bite, with bloodwork to confirm it. A healthy 40-something woman becomes a walking health disaster after a single tick bite. I don’t think we should continue to wait for studies to catch up to what patients are telling their doctors every day and getting ignored, repeatedly. Every day adds more lives lost to preventable tick-borne illnesses.
- There are no Lyme Literate MD’s within 1-hour drive of my residence. When a person is this sick, they are unable to drive longer distances or at all, so their care becomes a burden of both time and expense on families. Lyme disease has a significant impact on families with burden of duties, loss of income, need for care, and other financial burdens.
- The AGS allergy impacts entire families. Many with AGS cannot be around fumes of cooking meat. This means no meat can be cooked inside the home, and those with the allergy must avoid most restaurants.
- Mammal ingredients are hidden in so many products, even gelatin in jello and other products which appear to be vegan but are not. Every single ingredient on labels needs to be looked at and determined the source of. Prescription drugs contain mammal ingredients. Capsules are made with gelatin from beef. Vaccinations can contain hidden mammal ingredients. Health and beauty products are loaded with mammal ingredients. Every single encounter with a food or product is a potentially life-threatening reaction when there are hidden mammal ingredients. Many more people have the AGS allergy than in the past. Many people have the allergy for 20-30 years and it has not gone away. Some do recover quickly but many do not. I still have the allergy 3 years after the tick bite. Luckily, I have not had to go to the ER, but have come very close.
- Lyme Literate MD’s treatments are only partially covered by insurance at best. In effort to help the patient, LLMDs prescribe treatments not approved for Lyme disease but do work to both heal and decrease die-off symptoms. Some examples are Hyperbaric Oxygen Treatments, Nutritional IV’s, Infrared Saunas, Infrared Bio mat, Ionic Foot Baths, Herbal tinctures and supplements, etc. These have all been mostly out of pocket expenses for me but worth every penny.
- I was told by my employer while I was on short term disability that my position had been eliminated. I was too sick to work and lost my job. Forced to pay for most of my treatments out of pocket. This has put my family in a financial crisis.
- I have been denied SS Disability. Yet, I have had significant cognitive decline since the tick bite, have brain MRI showing neurodegeneration in multiple areas of my brain and have many symptoms of neurodegeneration, including weakness on the left side of my body, severe photosensitivity, sensitivity to noise, cognitive decline, and tremors.
Here are my recommendations for the TBDWG:
- AGS and other "tick-borne conditions" should all be included in the US funded Tick-borne Disease research. The language in which the research is conducted will be recommended to include AGS and other conditions.
- More education needed about TBCs including AGS and it's far reaching needs/support for the patient.
- Pharmaceutical Impact needs research and changes in some areas. Research needed for alternative treatments and medications with less dangerous side effects.
- AGS labeling concerns needs investigation; foods, health and beauty products, and medications.
- Need for more protection in areas of discrimination with an employer, school, medical community, health and life insurance.
- Need for updated CDC website and other state resource websites.
- Need to educate healthcare providers on better testing, diagnosis, treatments, etc. IE. Do NOT rely on CDC website as it was never meant to be used as a diagnostic health care tool or as a tool for insurance agencies to validate a claim.
- Need to include tick-borne conditions trainings in the medical schools and continuing education. Also include training in alternative treatments and wide awareness that treatment needs vary widely, and patient should be afforded every opportunity to recover regardless of CDC or other federal guidelines. There is no one size fits all for lyme disease treatment.
- Increase and improve public awareness on various ticks and associated conditions. Prevention and safe tick removal.
- Research involving children with TBCs.
- Protection for physicians who choose to treat TBCs. Currently, physicians shy away due to unfavorable retaliations from various entities. Some states have created new protection laws, but more safeguards are needed.
- Special consideration for the recovering patient, already diagnosed with Lyme disease or other tick- borne illness, who gets bitten again, while recovering. This can be catastrophic to their recovery and wreak havoc on their already compromised immune system. There is no end to the lengths we go to avoid another tick bite, mostly with avoidance of daily life in areas where most people go and frequent with no problems such as parks, trails, woods, or even back yards.
A family should not have to go broke while recovering from a Tick-Borne Illness. Ticks are here to stay, and data shows they are growing in numbers while tick borne diseases increase across the country. Please consider that many more people just like me are out there and would write in but are too sick to submit comments. Parents are spending all their money, time, and energy to help their children recover from tick borne diseases. I’m able to get out of bed every day, I consider myself one of the lucky ones.
Thank you for your time and consideration.
Carla S. Jones
Date of bite : May/June 2012
Location: Prince William Forest Park, Triangle, VA
I was camping in this national park and was bitten by a lone star tick. It left a dime sized purple bruise on my chest that lasted for at least a week. I do not eat red meat regularly, so it was a few weeks afterwards that I ate red meat during a night away in town. I ate the food around 4am, at roughly 8 am, I woke up with my skin swollen around my entire body and with unbearable itchiness on my entire body. I had never had an allergic reaction before, and assumed that some hydration and food would resolve the issue. On the train home, my vision started blacking out. I passed out on the train station and hit my head on the concrete floor. I ended up at a hospital, where the assumed cause was dehydration. A saline bag was placed into my arm, and my symptoms cleared slowly. My mother had also suspected an allergic reaction and given 1 tablet of benadryl before I was taken to the hospital.
I later self-diagnosed the issue around 3 weeks after around July 4th after suffering another attack after eating meat. This time I successfully resolved the attack with benadryl. That confirmed it was an allergy. I had read about this tick allergy previously in the news and after testing eating meat a few more times, confirmed the cause. I have avoided eating meat since that time.
I got formally tested by an allergist in the beginning of 2018, using a blood test, which confirmed the allergy.
I am writing to you this afternoon to relay my tick borne illness, specifically AGS- Alpha-Gal Syndrome.
On May 12, 2012 in Orange County, North Carolina, I was bit by a Lone Star tick and my life was forever changed. Four weeks after the tick bite, I started experiencing flu like symptoms, body aches, headaches and mental fog. I went to UNC ER and was given a 30 day dose of doxycycline to prevent Lyme Disease. My symptoms remained and at times I could barely walk, hold anything in my hands, or carry on a conversation.
I began seeking answers and help for the next 4 years. Specialist after specialist diagnosed me with Post Chronic Lyme, Fibromyalgia, Rheumatoid Arthritis, Lupus, and was even told that it was all in my head and that same doctor proceeded to ask me about my sex life with my husband and that i might just be depressed. My own practitioner was of no help. I keep presenting her with a long list of symptoms and was told that I was a diabetic and for me to get used to it. After months of being on diabetic medications that she prescribed and finding that my sugar would drop to 36 and each time she would just say to cut back on one of my medications, I had had enough. I threw away all of my medicine and was determined to figure this out on my own, because the medical professionals had let me down.
Something was causing hives, joint pain, throat tightness, fatigue and a constant rash. I started thinking it was environmental and began the tedious process of eliminating one thing at a time. When my symptoms continued, I then thought about a food allergy and started keeping a food journal. Within 2 weeks, I found that anytime I ate beef or pork, my symptoms flared up. I then turned to Google and searched allergic to beef and up popped Alpha-Gal.
I made yet another appointment with my GP and presented her with my findings. She told me that she never heard of Alpha-Gal and suggested that I find an allergist. I did find an allergist, he did a simple blood test and it was confirmed, I have Alpha- Gal Syndrome.
I am allergic to ALL mammalian meats and dairy. I can NOT have any mammalian by-products in my food, medicine or health and beauty products. I also react to the fumes of any cooking mammalian meat. I must carry an EpiPen on me at all times, because of the risk of going into anaphylactic shock.
Though we are a small segment of the population, we need help.
Please help us with more research, better labeling on all food, medicine and health care products, protection from discrimination from employers, health and life insurance companies, information on the CDC website, and educate health care professionals.
Thank you for your time.
Willow Spring, NC
I am a 68 year old farmer's wife living in Kentucky. In May 2013, I was bitten by three Lone Star ticks. Within a day, my bite marks were large, red swollen sites. In about two weeks, I noticed a feeling of being unwell. My whole body was off - fatigue, tremendous joint pain, horrible headaches. We were busy on the farm and I attributed my being unwell to hard work and age. This continued until early fall. On October 1, 2013, I went to McDonald's with friends at 9pm. I had cheeseburger and fries.
At 4:30am, I woke up covered in hives, my heart was in tachycardia and my left arm was hurting like a heart attack and my left hand was swelling like a catcher's mitt. Our farm is 18 miles from nearest ER. We were terrified I wouldn't live long enough for ambulance to arrive so we drove. My voice became very hoarse, due to my throat swelling and cutting off my breathing. I was given meds there to stop the reaction and kept for several hours.
Within days, I was referred to an allergist who knew immediately it was the Alpha Gal Allergy. Blood tests were done to confirm. I was told to avoid red meat. I continued to have reactions but none as bad as the first. My body felt like it was constantly under attack. Everywhere I turned, I was having reactions! My doctors didn't know enough about it to help me. When I mentioned that I was reacting to milk and cheese, they told me it contained mammal so stop it as well. When I started reacting to my clothes, household linens, due to mammal in my detergents, they suggested I was taking allergy too far, and maybe I was just being over dramatic. It was like my allergy was progressing, was a runaway train and I couldn't get off! Then I started reacting to the smell of any mammal cooking. I was terrified! How was I going to manage this way of living? It was like I was in constant reactions to my whole world. Everywhere I turned, something offended my system. When I started reacting to the fumes, I mentioned to new allergist, he told me I was getting too emotional about this allergy and that he would like to send me to a psychologist. I left his office, angry, yet questioning my own sanity, and still needing help to handle being around mammal fumes.
Mammal fumes can come from mammal meat cooking, fresh asphalt on the road, dead skunk, dander from any mammal, i.e. cat, dog, goat room fresheners, soaps, perfumes. It seemed like no matter where I turned, there was the smell of mammal. My world became very small. I could no longer walk into a restaurant, a gas station to pay for my gas because they had hot dogs on grill. I can no longer visit my family and friends, due to smells in their homes. I had to stop church because of perfumes. When my husband was in the hospital, I had to leave the building when they brought meals around. Can you imagine if just the smell of a hot pizza (mozzarella cheese) could in minutes make you so ill, gasping for breath as your throat closed and made you unconscious?
It happened to me while waiting for my husband to come out of doctor office. We were next door to Pizza Hut. I had to wait in the car because girls in the office were microwaving their mammal lunch and I reacted. Very few places are safe for me to go.
Being a farmer’s wife, the Alpha Gal allergy has affected what animals we can have here now. We just have 3 mini horses. At times, I am so allergic to them I have to wear coveralls, goggles, mask, gloves to brush them. I have two dogs that thankfully, I can be around but all these animals live here at their own peril. If they were to become ill or hurt, I could not help them. Their blood could send me into a terrible reaction.
Please help us with our quest for more research. This is not only a debilitating and life threatening allergy, it is a huge strain on the economy. Many millions of dollars are needlessly spent on medical tests searching for other reasons for our reactions, as many doctors are not aware of this allergy. And the lost revenue to the restaurants, stores I can no longer patronize. Thank you for allowing us to share our story.
Please bear with me. I have Alpha Gal/Red Meat Syndrome from a tick bite.
You have lunch coming up and in horror you realize you forgot to bring something from home to eat because it was late with the kids baseball games and you were tired. Can you find something that's not mammal or have mammal by-products in it so you can eat? Buffet is out since cross contamination could easily happen. You can't eat in the break room since the flumes of mammal heating by coworkers will set you off with maybe a life threatening attack....oh no, do you have your expensive ($242 out of pocket) Epi-pen with you?
You hope you don't see anyone who wants a hug and they ate mammal as that could set you off too, and there's no sex tonight since hubby is having steak with co-workers.
How about a fast food place since you have a short lunch hour? Do they add beef or lard to their oil they cook in like some places, or cook their bacon or pork sausage in the fryer? Don't forget, check, check, check.
It's so scary eating out since cross contamination can be life threatening and a lot of restaurants don't really understand cross contamination. Do you? YOU better!! since another terrible trip to the ER where they don't know about Alpha Gal or when admitted to the hospital personal didn't know either and gives you things with meat by-product in them or even pea soup.
Wonder how many people die from Anaphylaxis and the doctors don't know it was from the meal the person ate hours ago?
At least at home you can use your own pans and utensils that the rest of the family doesn't use, but oh, you are so tired to cook for yourself and also the family too when you get home from work. Double the work but at least you can be around the flumes where others can't so they can't even eat with family.
What is in 'natural spices'? Do those turkey hot dogs or sausages have casing made from beef or pork?
You finally found a doctor who believes you that there is a life threatening allergy from a tick bite, but he just thinks you are crazy person when you mention you are reacting to your shampoo, toothpaste, deodorant and lotion. Still looking for a lotion you can use, takes time to find stuff that's mammal by-product FREE. Read, read and call, call, call for information.
You had to use your epi-pen since the shrimp you ate last night must have been plumped up with Gelatin (by-product). It could have also been the plumped up chicken the day before. Have to buy expensive Epi-pens again. The ER people didn't really believe you about your allergy.
You've been so tired lately, just plain sick feeling with heart racing that you figure you must be allergic to milk and cheese, there goes your favorite recipes.
Get together with friends, church, and family have been really scary and now you have to worry about milk and cheese on top of it all.
I just had to turn down Joyce last week about a BBQ since they have no designated part of the grill to do a chicken I would bring for me, I'd bring my own utensils too. Friends are now thinking you are crazy that you are making more out of your allergy than needs be.
Your new heart medication the heart specialist put you on you had a reaction. So here we go again to try to find the right person to talk to at the manufacturer of the medicine to see if it has mammal by-product in it.
You reacted to the flu vaccine this year so won't be getting that again or a tetanus shot, others you need to check manufacturer, so there's another 2 hours or more taken away from just living to find information.
When will your life become less stressful again so you don't have to worry about the very thing we need to stay alive...food and medicine and personal items? People don't like it at the grocery store as you have to stand there and read, read, and read labels.
The world seems so hazardous to live in and complicated and very few, even doctors, know about it. The information you read says this is in the eastern and southern part of the US. Wonder what bite you in Kansas in 2005? You know it was the Lone Star as you saw the many aggressive ticks with a white dot on you.
You feel so sad as the public and doctors are so unaware what's out there. And to think so many children as young as four are getting sick from a tick bite and can't eat meat or gelatin.
You remember as a child you practiced at school getting under desk in case we were bombed. Why aren't we teaching this about this life-threatening allergy at least in Medical Schools and ER personal??
Had this since 2005 and grandson had RMSF in the 90's, both in Kansas. Don't think either were ever reported.
Dear Tick-borne Disease Working Group,
I have been debilitated with tick-borne infections since June 5, 2013. I hope this letter will help convince the members of the TBDWG to advocate for more humane TBD guidelines and release massive federal funding for research on effective treatment for TBDs, especially in their chronic form.
Who I was before I got sick: a summa cum laude Ivy League graduate, highly recruited NCAA Division 1 athlete, and returned Peace Corps volunteer who served the United States for 3 yrs in West Africa. I hold a Master of Science in Bioresouce Engineering and I’ve worked for the US government, NGOs, and a Silicon Valley start-up. Immediately before I got sick I bike commuted 18 miles a day to my dream job, an entry-level position at an international development NGO in the Washington DC area. I've encountered many challenges in my life and successfully overcome them, until I met TBDs. While TBDs have infected my brain, it is indifference from policy-makers who set NIH research agendas, inaccurate CDC guidance, flawed IDSA guidelines, and a dis-believing employment disability system that have added serious insult to the injury.
Who I am now: I haven’t been able to work for 46 months. I'm debilitated by fatigue and intermittent cognitive problems, sometimes so severe that I cannot read simple sentences, speak coherently, or process the world around me and instead sob in confusion and distress believing I have no hope and no value. I require 12+ hrs of sleep per day without the slightest sound, vibration, or light penetrating my cocoon of earplugs, black-out curtains, and eye-mask. I’m often foggy and can’t rely on my brain to think properly. I experience powerful mood disruptions of rage, irritability and self-pity such that I need to isolate myself to avoid alienating the few people who love and support me. These mood disturbances coupled with cognitive difficulties are akin to having your self-critic on loudspeaker or ruminating on all the wrongs ever done to you in your life. Additionally, I face: severe insomnia, visual problems (tracking, blurred vision), light and sound sensitivity, thermo-dysregulation, sharp head and ear pain, aching legs, and burning, numbness and twitching. In my worst years, I had to pace myself to do only one or two things a day in which one activity might be making eggs for breakfast, and the second activity might be watching TV after a 5 hr nap. The social interactive cognitive demands of having a routine conversation, making a simple decision (as to what to eat for lunch, for example), or replying to a text message can trigger a symptom flare and the humiliation of unravelling. All I can do when I'm at my worst is lay in bed counting my breaths and endure the distress. For years I’ve existed in the forgotten isolated littoral zone between aliveness and not-aliveness. I remain ambitious and curious but don’t have the ability to act on these drives.
Please address flaws in TBDs research and find effective treatment by:
- Massively expanding funding for TBDs research: The few existing studies on borrelia are flawed in their small n sample sizes and inappropriate focus on male subjects and rheumatological symptoms. Breast cancer, HIV/AIDS, Zika, and West Nile all receive more funding per patient from the NIH than borrelia and other TBDs yet borrelia (Lyme) is a greater public health problem. Furthermore, current treatment options are ineffective for large numbers of people, including me. Several months after my tick bite, dealing with very odd and notable fatigue, I sought medical care but was informed by my MD's office I had to wait 6 weeks for an appointment. At that point, I trusted the system and had no idea how to advocate for myself. Is that my fault? My primary care doctor ordered the Western Blot test, which was positive, and prescribed doxycycline. Three weeks of doxycycline didn't help me. I sought care from an infectious disease doctor: 2 months of cefuroxime axetil, 6 weeks of IV ceftiaxome and 1 month of azithromycin did not help. My caring, experienced ID doctor treated me to the full extent of IDSA guidelines and their only effect was constipation and no discernible improvement in my condition. So yes, the symptoms were all in my head and I was full of sh*t - literally ... devastatingly. An additional 6.5 months of hydroxychloroquine and clarithromycin followed by 5.5 months of tetracycline also made no discernible difference except even more severe constipation, which was a side effect I was willing to endure if only the treatment worked. My suffering and desperation were such that if there had been a treatment that would have given me 20 good years of productive life and then certain death in my early 50s, I sincerely would have taken it. I was constantly having to conduct cost-benefit analyses in which the health, financial and psychological costs and benefits were unknown. In total I took 638,000 mg (or 1.4 lbs) of antibiotics over 18 months with no improvement. The end-point of IDSA guidelines, which I reached in spring 2014 when illness persisted after treatment, seems to be: "Tough luck, something else must be the problem, can't help you and don't care." Since when has 'tough luck' been an acceptable response to 3 million (1) Americans suffering in morbidity, unable to live productive contributing lives? Answer: it’s not acceptable. I’m very slowly regaining health through a daily regime of 90 pills, 10 liquids, 3 powders and 1 injection, 12+ hours of sleep, and full-time rest. I believe patients should be able to do intensive antibiotic therapy - it’s possible that all those antibiotics prevented my condition from deteriorating worse than it did - but I’m disappointed antibiotics were inadequate for my recovery. I am supportive of ILADS, clinical diagnosis, and patient choice. I'm disappointed in the paltry the state of research funding for TBDs because 3 million Americans need better treatment and we needed it yesterday.
- Including subjects like me: female, young, with primarily neurological symptoms: I have several positive IgM Western Blot tests for borrelia and the clinical symptoms of it, positive rickettsia titers, suspected bartonella and babesia, an abnormal brain SPECT showing decreased perfusion to my right temporal and parietal lobes and basal ganglia, and an abnormal nerve conduction study showing polyneuropathy. I did NOT have a positive ELISA test, NOR a rash at the site of my bite, NOR do I have arthritis, joint pain, severe muscle pain, or physical mobility issues (aside from fatigue). The artificially narrow definition of borrelia (requiring an EM rash) and PTLD (requiring objective rheumatological symptoms such as visible joint swelling) disqualifies people like me from being research subjects. Perhaps these artificially narrow definitions are more accurate for male borrelia patients than for female patients. Certainly these narrow definitions exclude the sickest and most needy from the process of discovering a treatment. TBDs disproportionately affect women but the human and animal model research doesn’t represent us. A non-representative focus on male patients in borrelia research is a shameful relic of male bias in medicine and excludes the actual humans - tax payers, American citizens, and predominantly female - who suffer disproportionately from borrelia and other TBDs. For medicine and science to work for us, TBD research must study female animals and humans.
- Focusing on both co-infections and co-morbid factors: In 2013 I had several consistently positive rickettsia rickettsii titers. In Oct 2003 in South Africa, I had an embedded tick and a week of MD-diagnosed but untreated ‘African tick bite fever’ (rickettsia africae). No doctor has been able to tell me if my positive rickettsia rickettsii titre in 2013 was indicative of RMSF or a flare of rickettsia africae. Did I acquire other tick-borne infections in 2003 that my immune system largely held at bay until 2013 when I had two known tick exposures (1. Tiny ticks crawled all over me while I unwittingly sat in a pile of leaves and 2. Embedded tick in my hip and a non-embedded tick in my hair)? How does a semester of mononucleosis in 2004 relate to my current (2013-present) severe chronic illness? How does positive c. pneumonia or positive HHV 6 relate to my current illness? My symptoms are markedly worse at certain times in my menstrual cycle - what is the interaction between hormones and infection? What is the interaction between female immune systems and TBD infection? Research on dozens of TBDs and other co-occurring factors needs to be funded. We need more accurate and specific tests to know what infections are making us ill. Then we need effective treatments.
CDC guidance is incomplete and doesn't reflect best science:
When I found a tick embedded in my hip after a canoe trip in Virginia in 2013 I relied on the CDC website but it led me astray. The information on the CDC website in 2013 was flawed:
- no recommendation to send the tick for testing, so I don’t know what infections it transmitted.
- false emphasis on an EM rash for seeking medical attention. I never developed any rash, (perhaps because the infection suppressed my immune system) and the site of the bite developed a very small hard lump which, months later, I squeezed out like a white, waxy clogged pore.
- absence of persistent fatigue, dizziness, or strep-throat-like symptoms as reasons to seek medical attention. I had all three of these symptoms within weeks of my tick bite but they weren't 'flu-like' symptoms so I seek medical attention. Due to the mis-information on the CDC website I missed the crucial early treatment window that could have prevented 5 years of suffering and 4 years (so far) of missed income, productivity and career development. I’ve lost ~ $254,000 in income from not being able to work and faced ~$54,000 in direct medical expenses, not to mention living expenses.
Conventional IDSA guidelines are not only flawed but actively harmful to patients because:
- IDSA guidelines are used by health insurance to justify lack of coverage: IDSA guidelines are wrong to say that Lyme and TBDs are easy to diagnose and easy to treat. TBDs are very difficult and expensive to treat with no guarantees of recovery. After losing my job due to TBD disability, I got Medi-Cal health insurance which doesn't cover long term TBD treatment per IDSA guidelines. The slow improvements in my health this year are due to 3 yrs of $1500-$2000/month out-of-pocket medical expenses, at a time when I'm unable to work. Most sick people don’t have access to money for out-of-pocket treatment.
- IDSA guidelines are used by mainstream MDs to justify disinterest and force patients to navigate a deeply politicized medical landscape: Early in my illness I saw a top-rated neurologist who spoke ill of my top-rated Lyme-literate-MD saying he had landed some of her patients in the ER with permanent nerve damage. I was too scared to get treatment from this LLMD and instead continued with an IDSA MD. Maybe the neurologist's warning was warranted and saved me from harm or maybe it was nasty hyperbole that prevented me from quick recovery and resuming my job and precious little life. The head of Georgetown University Medical Center's Infectious Disease department rudely and dismissively told me I didn't have an infectious disease. When I asked her what I should do with my terrible fatigue and mental fog she said I should go to that LLMD, without acknowledging the obvious - that Lyme is an infectious disease, of which she said I had none. This circular run-around from doctors while my health and life were spiraling downwards was exhausting, demoralizing, and deeply confusing. A dermatologist I saw for an unrelated problem (deformed toenail) took it upon himself to note on my records that I “shouldn’t” be taking the high dose antibiotics I was on. This is an example of the tightrope that sick, confused, exhausted patients must walk – between appropriate deference to MDs and self-advocacy – just to access care, even for unrelated issues. Scorn, disbelief, and, most importantly, disinterest by medical staff added a harmful layer of fear and uncertainty when I was already facing the extraordinary burden of cognitive impairment and bone-crushing fatigue. Sick people are not equipped to fight to have our very common infectious diseases taken seriously or to be treated with dignity. One profoundly good piece of advice I got from an MD friend of an MD friend was "See a doctor who wants to see you.” Since when is it ok for MDs (like my Georgetown ID doctor and my neurologist) to dismiss patients, to ‘not want to see’ patients? Answer: since IDSA guidelines gave them permission to do so!
- IDSA guidelines create an excuse for callousness towards chronic TBD patients: Science-oriented people in my life who aren't in the medical field 'trust' convention (IDSA guidelines) on borrelia and other TBDs and are alternately skeptical, frustrated, and disinterested in my suffering. Close friends who are MDs in other specialties are mute on my situation and have largely fallen out of my life because they believe their infectious diseases colleagues who believe flawed IDSA guidelines. The politicized nature of TBDs interferes with patients receiving social and emotional support from their friends and family. Furthermore, the harm of flawed IDSA guidelines in the United States is magnified globally as many countries use them as a blueprint for their national TBD policies, expanding the callousness and disinterest to millions more patients around the world.
- IDSA guidelines cause self-doubt and emotional pain in patients: Between 2013 to 2015, my health deteriorated and I couldn’t do my job or take care of the basic activities of daily living. However, I felt like I couldn't explain or justify this situation because I had completed IDSA treatment and I was ‘supposed’ to be better. Did I lack willpower? With willpower I rewrote my senior college thesis in a couple days and won a best thesis award. How was I not able to will myself to health? Due to the falsely black-and-white IDSA guidelines, people who don't respond to treatment feel like failures -inadequate, disbelieved – and this interferes with making good health decisions. Every day I woke with very little in my energy tank and every day, as I used willpower to push myself into working a few hours in my job and trying to do basic errands (like pick up a prescription), I ran my energy reserves down to fumes and energy/illness deficit. The medical system and medication guidelines should have explained how serious my illness was and advised me to preserve and protect my body to fight these serious infections, the way they would have if I had a non-politicized, accepted, debilitating illness like cancer. Instead, 4 yrs later, I’m still trying to recover from this energy and illness deficit and this chronic illness.
Denial of employment disability benefits are justified by flawed IDSA guidelines:
Not getting better with existing treatment and paying high out-of-pocket medical expenses are only one side of the terrifying TBDs coin. The other equally terrifying side of the TBDs coin is losing one’s livelihood and falling through the cracks of disabilities protections; I can’t work due to Lyme-related disability yet employment disability insurance providers used IDSA falsehoods to deny the existence of chronic/post-treatment/late-stage illness, and Lyme-related disability is not included in the protections of the Americans with Disabilities Act. I paid into both Social Security Disability Insurance and ERISA (employer-provided) private disability insurance and according to the criteria, I clearly and easily qualified for benefits from both insurance systems. In practice, I was denied over and over, remaining disabled and without any income. I struggled to find an attorney for my private disability case because there wasn't enough money involved (my low NGO salary) to cover highly specialized attorney fees, and prospective attorneys declined to fight a fierce uphill battle against an insurance company loathe to pay benefits to a young person for a potentially long period of time. Once I found an attorney, the internal appeals process took years and immense distress, frustration, humiliation, and fear (energy and focus that would have been better applied to healing). Ultimately, I had to sue in federal court to solicit an insufficient settlement offer. My Social Security Disability Insurance case is still pending and at each step, the thoroughness and quality of my application has been used to justify denial of my case. My mom wants me to emphasize how difficult it is for someone with a disease that affects the brain to even fight the system to get benefits. It's a Catch-22 in which a sick disabled person is damned if they do (carefully and painstakingly rallying limited cognitive resources over a long period of time to complete an application) and damned if they don't apply at all. Inaccurate IDSA guidelines, which state that chronic Lyme doesn’t exist, prevent needy, deserving, sick people from getting lost-income supplementation - another example of patients hearing "tough luck, you're on your own". Not only do we lack effective medical treatment but we have nothing to catch us when we fall other than charity from family or friends, making it that much harder to take care of our poor suffering bodies and minds and get back to full productive lives.
Look beyond the angry white women to all those who suffer from TBDs in silence:
I have somehow survived the terror, profound grief and humiliation of 5 years of TBDs and have tempered hopes for maintaining a quality of life worth living, thanks to functional medicine. I'm a privileged white Ivy League graduate - Type-A, thorough, persistent, confident - who has nevertheless has quite a hard time finding and paying for treatment and only to moderate success. My demographics and privileges didn't cause me to become ill but they do give me the agency and outrage to report my experience to the TBDWG. I bet for every one of me there are many others who find it more difficult to be taken seriously by medical staff, navigate the tricky politicized medical landscape, and finance out-of-pocket treatment. I predict that TBDs affect people of color and people of lower educational attainment and socio-economic status at significant rates but that medical and public health officials don't see evidence of this because they aren't looking for it. Please start looking in other population groups because the infection rate and disease burden is likely much higher than currently estimated.
We need the TBDWG to address immense human suffering, the 'bad outcomes':
Too much of the past decades of messaging on TBDs has been dominated by prevention of tick bites and false claims that borrelia is easily treated. As a patient, I implore the TBDW, to focus on the problems such as: poor surveillance and data collection on ticks and infection rates, inadequately accurate and specific tests, lack of effective treatments, lack of research funding on chronic/ late-stage/ post-treatment illness, high morbidity, high rates of partial or full disability, and inadequate access to employment disability insurance benefits. Do not balance my suffering with the good health of another person who was lucky to respond to existing antibiotic treatment. The TBDWG should not be meeting to congratulate the IDSA on the patients for whom these guidelines worked, nor to congratulate the NIH for failing to fund TBD research, nor to congratulate people whose innate immune systems protect them from TBDs. Instead you should focus on helping those who are suffering from the status quo.
No one wants to be this sick and no one wants to stay this sick. Thank you in advance for the hard work and courage it takes to fight for us. I appreciate the opportunity to have my letter included among patient comments for 2018.
(1) https://www.lymedisease.org/lymepolicywonk-costs-75billion/ — Lorraine Johnson (July 19, 2018) justifies a calculation of 1-3 million people with chronic borrelia using CDC reports and peer-reviewed literature, however this is an underestimation because it excludes people sick with non-borrelia TBDs, and excludes people sick with TBDs but not diagnosed
CDC's systematic undercounting of Lyme disease must stop now
By Dorothy Leland, LymeDisease.org
The CDC’s official count of approximately 30,000 Lyme disease cases per year in the United States has been a constant source of exasperation to the Lyme community. Even after the agency acknowledged some years back that it estimates the true figure to be 10 times higher—300,000+ cases per year—the annual “reported” number has remained in the 30,000 range.
(“Reported” actually means: cases which meet CDC’s rigid surveillance criteria, leaving out tens of thousands of diagnosed cases of Lyme disease because they don’t meet that high bar.)
For years, the agency has insisted that 95% of Lyme cases are found in just 14 states. For a long time, the Lyme disease page of the CDC website contained the following sentence: “This disease does not occur nationwide.” That wording was finally deleted last November, but the sentiment lives on.
The CDC continues to divide the country into what it terms “high-incidence” and “low-incidence” states for Lyme. If you live in a low-incidence state, you may find it practically impossible to get appropriate diagnosis and treatment for Lyme disease. Merely where you live becomes a huge barrier to access to care. Here’s why: the CDC has different case definitions for Lyme disease, depending on your state. For instance, an EM rash after a known tick exposure qualifies you for a Lyme diagnosis ONLY if you’re in a high-incidence state.
If you’re in a low-incidence state, you could have a known tick bite, a raging EM rash, as well as multiple symptoms of Lyme disease—and none of it would count. You’d only officially qualify as having Lyme if you also tested positive via the CDC’s highly problematic two-tier lab testing. (There are many reasons why a person who actually has Lyme can “flunk” that test.)
The Wall Street Journal recently published an eye-popping article about the deficiencies of the CDC’s method of counting Lyme cases. The following quote cites information from FAIR Health, a nonprofit organization that manages the nation’s largest database of privately billed health insurance claims:
“North Carolina reported 32 Lyme cases to the CDC in 2016 but in the same year made 88,539 health-care claims for a Lyme diagnosis. California reported 90 cases to the CDC but had 46,820 claims. Texas reported 31 cases to the CDC but had 31,129 claims. All three are considered low-incidence states.”
This data represents the number of “claim lines” reflecting services rendered to those with a Lyme diagnosis, not unique individuals with Lyme. It captures every time a person with Lyme receives an insurance-covered service in connection with a Lyme diagnosis. So, if North Carolina’s case number of 32 were at all accurate, that would mean each patient saw their doctor or had another Lyme-related interaction 2,766 times that year. Highly doubtful!
Yet, FAIR Health insurance claim lines don’t account for everybody with Lyme. Many patients are diagnosed and treated by Lyme-literate doctors—most of whom aren’t in the insurance system at all. In addition, many people with Lyme are never properly diagnosed, either going without healthcare entirely, or being misdiagnosed and treated for something else. They are of course not reflected in these statistics whatsoever.
Additional sources of information about Lyme cases throughout out the US also paint a different picture from the CDC’s. The most dramatically different one relates to canine cases. Between 2011 and 2015, Idexx Laboratories, Inc.—a provider of testing kits for dogs—collected nearly 12 million Lyme disease test results from US veterinarians, on a county-by-county basis.
IDEXX reports there are close to one million cases of canine Lyme disease every year in the US, vs. the CDC’s paltry 30,000 human cases. Even compared to the CDC’s estimate of 300,000, that’s still an extraordinary discrepancy. Furthermore, IDEXX statistics indicate that Lyme is present in abundance in every state in the US. This clearly suggests that there are a lot of Borrelia spirochetes in the national ecosystem, yes? Even people in supposed low-incidence states are at risk.
LymeDisease.org’s patient registry, MyLymeData, is also instructive on this point. Although our sample size is much smaller than the CDC’s, in many states throughout the south and west, MyLymeData reports more cases of Lyme disease than the CDC does.
The CDC’s inadequate counting of Lyme cases downplays the risk of catching the illness in most of the country. This creates a false sense of security and, in turn, encourages inattention on the part of public health officials, medical personnel, and the public at large. Too often, patients presenting with symptoms highly suggestive of Lyme disease are told “Can’t be Lyme. There’s no Lyme in our state.”
The plain fact is, no one knows enough about the true geographic distribution of Lyme disease to write off any state as being Lyme-free. Moreover, not allowing an EM rash to be considered diagnostic in certain states deprives many patients of their best chance at getting well. The current system in effect creates cases of chronic Lyme disease, because people can’t get diagnosed and treated while still in the acute phase.
I urge the Working Group to recommend the dismantling of this wrong-headed and counterproductive policy of the CDC. In your report to Congress, I hope you’ll also underscore the importance of obtaining accurate data about ticks, the infections they carry, and the number of tick-borne disease cases in all parts of the country. This information is essential if the United States is ever to get a handle on this burgeoning epidemic.
- Wall Street Journal, “Lyme Disease: An Even Bigger Threat Than You Think,” by Jo McGinty. June 22, 2018. https://www.wsj.com/articles/lyme-disease-an-even-bigger-threat-than-you-think-1529672401
- LymeDisease.org, “LYME POLICY WONK: Why doesn’t the CDC count Lyme disease cases in the South and the West? Everybody else does,” by Lorraine Johnson. August 3, 2017. https://www.lymedisease.org/lymepolicywonk-cdc-count-lyme-cases-south/
- LymeDisease.org, “TOUCHED BY LYME: No Lyme in Arkansas? Baloney!” by Dorothy Leland. September 26, 2016. https://www.lymedisease.org/touchedbylyme-arkansas-baloney/
I am 61yrs old and I live in Bradenton FL. My story started back in 1975. I graduated high school that year and I started my own auto repair business. Having limited funds I rented an old chicken coop on a closed down chicken farm in Edison, NJ. The farm was loaded with bugs and rats, and I found a tick in my head one day and my girlfriend pulled it out. I didn't know much about ticks in those days. A couple days later I was working under a car and all of a sudden I couldn't move. I started feeling sick and my dad and girlfriend dragged me out from under the car and took me home. I started to run a high temperature, and I was very sensitive to noise and light. After having a fever for a day or so, my mom took me to the hospital emergency room, and after running some blood work the doctor told me I had strep throat and sent me home. I kept getting worse so my mom took me to my allergist. I always had bad allergies, and every time I got sick the allergist would be the doctor who knew what to do for me. I was still having severe reactions to light and noise, and I needed help to walk. I had developed leg paralysis. The allergist examined me and took some time to think about what could be wrong. He looked through some medical books and then it hit him. He asked if I had been bitten by any insects and my girlfriend said "Yes I pulled a tick out of his head last week". He said that he had just learned about Rocky Mountain Spotted Fever recently and he thought that might be what I had. He made a phone call to another doctor, I think he was an internist, and he sent me over to his office.
This doctor examined me also and agreed with the allergist that it could be RMSF. I was told that there was an experimental drug for this but it wasn't available locally and the doctor would have to get it flown in to us. I don't know if it was DoxycycIine or not but I had to agree to give it a try knowing that it might not help. It gets very hard to remember the timeline on all my visits back to this doctor but I guess he reported this to the local health department and they would come to my house and make reports on my progress. It was a very slow progress, but eventually I learned how to use my legs again and after many months I was able to go back to work. In 2013 my girlfriend, who is now my wife contacted the health department in Edison, NJ to see if we could get copies of my records. They told us that they don't have records back that far.
Since this all started, I have been to many doctors who can't figure out what causes the aliments that I have. I am sick all the time, but I have a great doctor who tries to figure me out but the testing he orders for the different problems I keep having always comes back negative. I still have a spot on my head where I got bit that bleeds sometimes and doesn't heal up. My symptoms are joint and nerve pain, muscle pain, brain fog, trouble talking when I am flaring up, back pain, pain on the left side of my body, unexplained lumps in my legs, and my brain feels like it is being twisted to the point that I cannot think.
I have two children, a son who is 38 yrs old and a daughter who is 35 yrs old. They both have the similar problems that I have.
It seems like the doctors are not educated on RMSF and how to diagnose or treat it. I hope that the government will start to do studies on tick borne diseases and how it destroys the lives of the victims that are bitten by ticks.
Thank you for your time,
Joseph A. Leo
Four and a half years ago, I was an active runner, involved in animal rescue, an avid world traveler, and lived in the city where I frequented all the local eatery establishments for food and drink. If I couldn’t walk or ride my bike, I didn’t go. Except for work of course. A high level demanding position with frequent travel.
That whole world came crashing down around me and has continued to leave my life in pieces. Alpha Gal is not “just” an allergy.
On one of my trail runs in Richmond, VA, I picked up a tick that had latched onto my foot. I plucked it off and flushed it down the toilet without looking back. In hindsight, it was a few weeks later that I started having gastrointestinal issues. What seemed to be random stomach bloating, cramps, pain, diarrhea and vomiting. This went on for a few months. I had recently been to S Africa for three weeks and later in the year, on a backpack trip through Belize and Guatemala and logically assumed I picked something up during my travels. I made regular appointments with an Internist who did blood tests, stool samples and an upper and lower endoscopy. Everything was negative. It made no sense and was so frustrating. During this same time frame, I had also gone to Southeastern MD for a work trip where once again, while jogging in a state park I emerged completely covered in what apparently turned out to be nymph ticks. This was a huge turning point.
The vomiting and diarrhea eventually was happening upwards of 30 times a day. I was losing extreme weight. Nor could I control when and where it would hit. At times I began to pass out when I got so sick. I couldn’t understand why my whole body would break out in huge itchy red welts. Many times during the middle of the night I was rushed to the ER after I had passed out in the bathroom, vomiting and defecating on myself, skin swollen and bright red, my BP dropped, I was severely dehydrated and very confused and panicked - I tried to wear a business suit and steal a neighbors car to get to the hospital! What was happening with me?! In hindsight I understand this was happening due to the delayed reaction of Alpha Gal, I was experiencing multiple system anaphylaxis. This was the norm for me for a year and at one point I was told that I had about 3 months to live if I continued at this rate. After a full year of this, more hospital visits than I can count, and numerous specialists not having a clue what was going on, a friend of a friend sent me to an allergist who knew of a blood test and I fit the description of needing this Alpha Gal testing.
I was told to just not eat mammal meat and that I’d be fine. If only it was so easy. I tried this for six months and though I improved I wasn’t getting better. I was having random anaphylaxis still. Less frequent but still visits to ER. Hives all over my skin. What am I doing wrong? The original doctor who diagnosed me told me in his words that I was over reacting and needed to see a shrink. WHAT?!
As time went on, I learned that I needed to switch my hygiene products to vegan. Once I did that the hives on my head, neck, face and shoulders finally disappeared.
After much more research, I discovered that the medications I was taking was causing me to continue to have reactions. I didn’t know about gelatin in medication. Nor did I have a clue that magnesium stearate is mammal based. I tried to eat only a whole food diet of chicken, fish and vegetables. Anything packaged was too risky. When you read “natural ingredients”, it’s a catch all phrase and can very well mean mammal ingredients. I also got rid of my wool clothes - the hives were unbearable!
I slowly started eliminating these factors and each step made a little more difference.
Unfortunately, the permanent damage has been done. Along with the mammal allergy, I have since developed gluten intolerance, a mold mycotoxin illness, and allergies to dairy, lettuce and almonds. I don’t have a lot left to eat. Eating out is nearly impossible to meet such a strict diet and worry with cross contamination. Being so sick has destroyed my body in so many ways. I was left with Brain injury to include extreme short term memory loss, neurological issues, cognitive understanding, anxiety, anger and depression. My thyroid no longer works. My adrenal glands have shut down. My body threw me through a fast, premature and painful menopause. All of these require hormone replacement therapies of which each medication must be specifically made at a compound pharmacy so as not to have any gluten or mammal ingredients. I also have POTS now which causes my heart to act erratically, muscle weakness, exhaustion. With all that going on, of course I had to give up my passion of traveling but I couldn’t afford to anyway with special prescriptions costing me $400 a month! That doesn’t include my copays for the hospital visits, the many tests I’m still having to regularly get done, doctors appointments, etc.
I am only lucky to have maintained my job. I’m now registered with a disability and have to frequently request reasonable accommodations. I work from home more than I can make it to the office. My immune system is such that I cannot be exposed to the colds, flus and viruses that frequent a busy office. For me they turn into more serious illnesses often requiring doctor or hospital care. Let alone that by the time I get up, shower, dress, prepare my meals for the day and drive to work I’m exhausted and the work day hasn’t started.
My heart issues are still not under control. My thyroid is proving extremely difficult to level out and it’s been brought up that removal may be necessary for my body to quit fighting it.
The last five years of my life have been a blur of the medical world. Include the short term memory loss and I have basically lost the last five years of my life which I never get back. I continue to fight every day just to make it through each day. I’ve lost my social life. My family has suffered with me. This is not the same as normal age progression; my life has done a complete 180. Gone are the days of traveling the world or running 10k races. Gone are the days of carefree happy hours when you can’t eat the food and a drop of alcohol will send your body into a histamine fit. Gone are the days of making plans because from one hour to the next you don’t know how you are going to feel.
It is absolutely necessary to continue research efforts into this and even if it’s too late for me to have a happy fully functioning life, please prevent this from happening to the next person. Doctors, nurses and pharmacists need to be educated to the severity that this Syndrome can truly be.
Thank you for hearing my story.
I live in Raleigh, NC, and I'd like to share with you what I have been going through over the last year. An otherwise rather healthy 61 year old art teacher, I was bitten by a tick last summer. This particular tick bite was not like the norm. It itched for weeks and weeks - but I thought nothing of it.
Must have been sometime around July, because I remember picking some amazing tomatoes off my vines, and was craving a fresh and crunchy BLT. Man was it good - until about 6 hours later. I woke up covered in hives and rushed to the 24 hour pharmacy for benadryl cream and pills - and kept myself awake the rest of that night to make certain my reaction didn't accelerate.
How did I know to do this? Both my brother and first cousin have suffered from the Alpha Gal tick borne allergy for several years. I immediately made the connection and went for allergy tests. Off the charts, is what the doctor said, measuring 99.9.
What I have discovered since: my regular PA physician is not familiar with this allergy. I had to inform them that I cannot receive a vaccine that they recommend for people my age. Yes, I have to now research ANYTHING that my body will come in contact with, or may have a life threatening attack. This vaccine, after extensive research, contains hamster ovaries of sort. I had to dig deep for that...
Alpha Gal sufferers cannot be in contact with any mammalian products (and certain dairy as it is from a mammal). It is amazing to learn how many common products include mammal parts: gelatin, gel encapsulated pills, vaccines, wine, certain beers, most restaurants are off limits due to cross contamination with beef or pork, the list and concerns are too numerous to mention.
Sadly, as dangerous as it is for me to consume products, most of our professionals in the medical field are unaware of this ever growing problem. There is a recent study (April 2018) that doctors are also finding a correlation between alpha gal and heart disease. My heart doctor had never even HEARD of the allergy..... I think it should be an urgent call to action to educate everyone, and to help find those of us that suffer from this dreadful tick borne allergy some relief.
Thank you in advance,
This disease is wrecking families, finances and futures.
Will your endeavors lead to outcomes favorable for the most vulnerable and sickest stakeholders?
Or will a poor response by the tick borne disease working group be associated with an even higher infection rate and no valuable cure?
To date, members have failed to send a clear message about the seriousness of tick-borne sepsis. It is far more than a slight cognitive decline, a relapsing fever or an arthritic joint. It is a systemic demise with high resistance to treatments which causes disability and severe morbidity.
Loss of public confidence is evident. Uncertainty about this serious epidemic needs addressing. Transparency is paramount.
A thoughtful approach to wise leadership would be to First Define what the disease is.
Second, revisit Dearborn and the fraudulent diagnostic testing standards which have alienated the sickest of patients. These fellow humans are denied adequate treatment, community support, compassionate medical care or insurance coverage. It is a crime against humanity.
Lyme and Vector-borne diseases do not discriminate. They are crippling babies in utero, maiming innocent children, victimizing elderly, sickening our military service members and disabling untold numbers of citizens. Where will this madness end?
People deserve an efficient, timely and complete public health initiative to overcome this insidious disease.
TBDWG members need to contemplate decisions and attain the highest fiduciary standard possible.
Many lives depend on the outcome.
Let your words be anything but empty.
I have been following the TBD working group’s progress report regarding the treatment of Persistent/Chronic Lyme Disease and would like to recommend the inclusion in the report to Congress, in the appropriate category, the investigation of promising current alternative treatments being used in the US and in other countries. Alternative treatments should be investigated in light of more recent findings that antibiotic therapy alone is inadequate in killing Borellia Burgdorferi in monkeys and humans. Moreover, many people with Chronic/Persistent Lyme Disease are struggling to improve with the current antibiotic regimen and need a more effective treatment. A promising alternative treatment performed at the St. Georges Hospital at the Klinic in Bad Aibling, Germany utilizes a combination of whole body heat therapy and IV antibiotics. Comments from people around the world have indicated they have improved tremendously with this treatment. As a Microbiologist I know heat is very lethal to bacteria and other microorganisms, therefore, the underlying fundamentals of this therapy has validity. As a result of this information, we owe it to all the suffering people with Chronic/Persistent Lyme Disease to leave “no stone unturned” and investigate this therapy being used in Bad Aibling, Germany as soon as possible. The most effective treatment might be at our finger tips and we need to bring it to America to determine its effectiveness. If determined effective based on out the comes of the patients, insurance companies should be required to cover the expenses whether the treatment is performed in the United State or overseas. Thank you
Hopewell Junction, NY
Let’s talk about balance
By Phyllis Mervine, Founder and President, LymeDisease.org
Towards the end of the Tick-Borne Diseases Working Group (TBDWG) meeting on June 21, 2018, there was some discussion about the patient stories slated for inclusion in the report to illustrate various scenarios. TBDWG member Robert Smith, MD, noted that most of the stories chosen depict people suffering while waiting years for diagnosis, failing the two-tier testing criteria, having treatment cut off and having bad outcomes. Since many of the patients he treats do well, he said, he felt that the stories should reflect that reality. TBDWG Chairman John Aucott then agreed that the report is supposed to be “balanced.” The question of how to include a series of horror stories while comporting with the goal of “balance” remained unanswered.
Both Smith and Aucott are misreading the charter for the TBDWG. Congress intended, and the charter calls for members who represent diverse scientific disciplines and views. This is balance, and this is why the TBDWG includes representatives from all stakeholder groups: government and non-government, patients and advocates as well as scientists, researchers and doctors with a range of views. That’s why Smith was included—he is a member of the Infectious Diseases Society of America (IDSA) and supports that Society’s practice guidelines. Richard Horowitz represents the other end of the diagnostic and treatment spectrum as a member of the International Lyme and Associated Disease Society, which published the first Lyme guidelines to follow the rigorous GRADE evidence assessment protocol recommended by the Institute of Medicine. That is balance.
There is no mention of “balanced” stories. Dr. Smith, whose interests veer towards running large vaccine trials, thinks those diagnosed and treated early who become well need “equal” voice. But those people aren’t the ones struggling with illness. They don't need a community to fight for healthcare or just to get through their day. And the people who got better are not the people who fought to pass the legislation creating the TBDWG. They simply got on with their lives. They don’t need representation by anyone, including Dr. Smith, because they are well.
The purpose of the stories is to provide some human interest and incentivize Congress to act. People no doubt recall the PR campaign about the Zika virus in 2016. Media carried heart-rending stories and pictures of babies born with tiny heads—microcephaly. The world was horrified. But this is how you encourage people to act. And it worked. Congress earmarked $1.1 billion to fight Zika virus. This is the scale of effort we need for tick-borne diseases, now after decades of denial, neglect and deferred maintenance. Dr. Smith’s proposal to tell Congress tick-borne diseases are easy to diagnose and cure will simply undercut the whole purpose of the TBDWG. Why should our lawmakers act if there isn’t a problem? So let’s identify and illustrate the problem that the Working Group was established to address.
Let’s tell the stories of the patients who have been suffering without a voice--the stories about what happens when IDSA takes a restrictive surveillance case definition and wrongly insists that it should be used for clinical diagnosis, with disastrous consequences to patients. We need to hear about patients who are ridiculed and labelled as psychiatric cases or malingerers. Let’s tell those stories.
One would expect Dr. Smith, who is a member of the IDSA, to promote the IDSA view that "the vast majority” of patients recover with standard treatment. However, for patients who are diagnosed late—as far too many are—the success rate of treatments intended for acute illness is poor. Only half recover. Our large data project, MyLymeData, shows that 70% of people with persistent Lyme were not diagnosed until late stage. This is because they could not obtain a timely diagnosis. Most take three or more years to obtain an accurate diagnosis. Could we correct this? You bet! We could permit—or even encourage—clinical diagnosis of these patients, who don’t meet the restrictive CDC surveillance case definition. We could allow community physicians who treat them to do so without the threat of potentially losing their license from medical board actions.
Most of these patients report being profoundly ill for 10 or more years. Most have had to quit their jobs, reduce their work hours, or modify the type of work they do because of their functional impairment. And only 10% of our survey participants elect to see infectious disease specialists. Why? Because the IDSA protocols—which assume acute disease that is diagnosed early—don’t work for those who are diagnosed late. Could we do something about this? Yes! That’s why more than 10,000 Lyme patients leaned in over one week-end to pass the 21st Century Cures act that established the Working Group. These are the stories we need to tell.
To do these things, we need to tell the stories of the patients who are suffering because they were not diagnosed early and because we have not even begun to look for treatment options for those diagnosed late. The point of the TBDWG report is to encourage Congress to DO something about an epidemic we recognize is growing and which has a huge human cost. There’s no point in letting our legislators think there isn't really a problem.
Give them charts showing how cases have continued to climb every year with no indication of a slowdown. Tell them global climate change may even make the problem worse. Show Congress how funding for Lyme is in the basement. And run the bad stories--there are tons of them and they have been silenced for decades. You have to recognize the problem before you can address it. We should have done this years ago, but I’ll settle for today.
Cyndy Mishoe Capell
Thank you for taking the time to read my letter. I was diagnosed with Alpha Gal In September 2017. I was bit in May 2017 again by a Lonestar tick. I was extremely sick for three years and a half before that. No one could figure out what was wrong and they diagnosed me with anxiety and put me on Xanax. Every once in a while I felt okay, but I could be standing and talking to somebody and all of a sudden feel like I was going to faint. I thought this was my new life. In August of last year I finally went to see an allergist. I was so sick when I walked in I thought I was going to die. When I got the diagnosis I cried because I realized that I was not gonna die and something really was wrong with me. Since stopping eating red meat I have not had a so-called an Anxiety since. I have been sick for so long I have really messed up my body and now have very high histamine‘s. Please take this into consideration.
Thanks so much for your time.
Cyndy Mishoe Capell
Hello Tickborne Disease Working Group
Thank you for all you are doing for all of us in need of help due to being bitten by an external parasite commonly called Ticks.
I am 57 years old and have had Alpha Gal for about 11 years now. 6 of those years I was Undiagnosed. 3 of those 6 years was spent trying to convince doctors that I knew something was wrong with me. At the end of those 6 years I had a sit in at a Lab Corp and told them to locate where to send my blood for a test for alpha Galactose 1 3. Spent 3 hours there until they located Viacor labs, I took the lab slip back to my doctor where she rolled her eyes and reluctantly signed the lab request for the full Alpha Gal panel. Which turned out to be positive. I was the second person in the state of Delaware to be diagnosed with it. During my 11 years with Alpha Gal I have been treated by the medical community like I had lost my mind , was irrelevant , was crazy , because Doctors don’t want to believe I have Alpha Gal. I have suffered through anaphylaxis from eating a cheese steak sub, ice cream, cooking fumes from venison and was hospitalized for four days because I ate pea soup cooked with a ham bone in it!! I suffered with chronic urticaria, which I refer to as the 3 year rash from hell , that I contacted in Oahu Hawaii ... most expensive and only vacation I have had in my life and it was ruined by hiking to the top of Diamond Head Mountain and while on top I got bit by a bunch of tiny flies, which activated my AG and ruined my trip. Crazy itching hives from head to toe ... ( NIH released a study in April 2018 warning about getting rebittten by flying insects and how it will Retrigger Alpha Gal symptoms - too bad it wasn’t published a few years earlier).
In the beginning of my Alpha Gal symptoms, I was convinced I had Lyme disease. I had light sensitivities, vertigo, random fevers, night sweats, neck aches, migraines, body aches and hives. Which brings me to my main point of concern regarding Alpha Gal.
By the time we get diagnosed we have not been treated with doxycycline because Alpha Gal is treated like an allergy, when In fact it’s a Tickborne Illness. But because we get sent to an allergist the majority of alpha gal patients are not being treated prophylactically. I have taken polls on both Alpha Gal pages on Facebook which gets me connected to approximately 3000 -4000 people. And the majority of us never get doxycycline treatment. And the majority of Alpha Gal patients suffer from the majority of the ailments I have mentioned above. The majority of us get the western blot test before we get the Alpha Gal diagnoses. Most of us get told that along with Alpha Gal we have fibromyalgia!! Which means we are not getting the proper medication.
It is my wish that you please recommend Alpha Gal to be considered a full blown Tickborne Disease so doctors and other medical professionals can properly treat us.
It’s also my wish that you establish a National Protocal for all tick Bites. Perhaps there could be a study on giving Alpha Gal patients doxycycline on the onset of a bite before we see an allergist. Maybe we wouldn’t suffer the above Lyme like symptoms.
Or perhaps there should be a study to see if we have a Tickborne Disease (perhaps not named yet or truly discovered ) and Alpha Gal is a coinfection!!!
We also need updated information and transparency from both the CDC and FDA. Showing the spread of Alpha Gal and name change for Alpha Gal (if approved), and proper labeling on all medications and food. For active and inactive ingredients.
Thank you for your considerations on all of the points I’ve presented to the Tickborne Disease Working Group ... We need help ...you are our best advocates at this point. Please Help Us.
Deborah A Olsen
I am writing you today to let you know some of my experiences and concerns related to the Alpha-Gal allergy. I was diagnosed almost one year ago, after an anaphylactic reaction sent me to the local ER. I followed up with an allergist who surprisingly quickly diagnosed me with Alpha-Gal. My anaphylactic event occurred in the early AM after eating a taco salad with ground beef, several hours prior. I was lucky this physician was familiar with this allergy and questioned me concerning tick exposure. Looking back, I had actually had a few other midnight events, both after eating a ground beef meal. I also had a four year medical history of seemingly random hives that would occur on my fingertips, bra line, lip and tongue. I was worked up by family practice and internal medicine without answers. Strangely, these hives were more prevalent in the spring and subsided in the fall. I would go morel mushroom hunting in Missouri in April and May of each year. I would usually get a few tick bites. The last year, I had a known Lone Star tick attached on my trunk.
Changing to a diet of no mammal meat was a devastating idea to me. I am a person that enjoys food, including steaks, smoked bbq, ham, burgers--you get the idea. I did understand that people can and do live without these things in their diet and are probably healthier for it. I did understand it would just be a pity factor for me. But also, I discovered that going without the mammal meat was the easiest part of the past year’s journey. This Alpha-Gal Syndrome has affected my life in several ways. It can be all encompassing, although I try not to give it that space.
Once diagnosed, I immediately set out to find out everything I could about this condition. Wow, talk about a dead end. There is very little written, scientifically founded, literature available. Alpha-Gal allergy was identified some 10 years ago, but that is still new to the medicine and research world. Most of the information dated back to the initial findings also. There is no reference book for Alpha-Gal. No standard prescription for what to eat, avoid, medications to use, other physical issues to be concerned about. With the exception of the allergist who diagnosed me, I did not find anyone in the area to have heard of the condition. I work at a small hospital and come into contact with several providers, some of whom come from major metropolitan medical centers, and I was the one educating them in this case. What I did find were a couple of Facebook user groups. These groups are full of people like me. Some are very knowledgeable. Some are very new and scared of what is happening in their life now. Some seem like major hypochondriacs, until you are experiencing the same phenomena that they have described. Overall, this group has been indispensable. I do hate not having a better source of information and hate having to preface every answer with “my facebook group says...” because I know what people are thinking.
My reactions progressed after the anaphylaxis, to being more tongue swelling, itching, tingling, and now stomach pain. Despite efforts to be mammal free in household and personal products, and to eat clean, my tongue still has some degree of swelling over 50% of the time and it is scalloped from the edema. The tongue swell fears me most, and I sleep with CPAP to help keep my airway open. Fortunately, I have managed to keep big reactions at bay, and have not had to use the Epi pen, although I know now that there have been times when I should have. One of my major issues has been what they refer to as fume reactions. I could at first cook mammal meats for my family but soon progressed to this bothering me. So much now that I try to avoid even being in the room when it is cooking. The symptoms with that are more immediate. I feel a heightened sense of smell. I start getting anxious, nauseous, have difficulty concentrating, feel tingling in different areas such as hands and feet, maybe a twitch or itch around my face, and sometimes weakness in the elbows. I have had to leave certain restaurants because of this. I also experience this in some grocery stores, usually to a lesser extent. This is something that has been an issue for me at work with staff: cooking taco meat or nacho cheese in a slow cooker; staff all eating hot steaming brisket lunch in the lounge; the front lobby reeking of bacon in the morning; my office being located directly over the kitchen; and my trying to respond to a fire alarm in the kitchen and having to leave due to meatloaf baking fumes overwhelming me. I have also had some of the same reactions to heavy use of cleaning products at work and in places where there are a lot of candles, scented things. I can be having a really good day, and this exposure can ruin it for hours. I recently tried to tell my allergist of this experience and was humiliated by his response. He stated that this fume/inhalation reaction is not scientifically possible. He assured me that I would not die from a fume reaction, or if I did he would write it up in a paper. He stated three times that it was all in my mind. He suggested if not in my mind, it may be my high anxiety or other chronic disease state. I tried to tell him that there are hundreds of others out there, sharing this same experience. I asked how then, does the information from patients get back to providers in absence of a study? He said that sometimes they will send him a survey. I doubt from his denials that he would seriously report any of my symptoms. Btw I am not an anxious person. I waited for this 6 month follow up and was just trying to relay to him what had been bothering me most. I have 25+ years of experience as a Registered Nurse and serve as director of a surgery department. I am used to being seen as a reliable source when reporting symptoms of my own and otherwise to physicians, and this was a very difficult situation for me.
Dairy is another food group that I have had to pretty much eliminate. There is no good information in this area either. I had found an answer to a question in a professional journal that stated some relative values of Alpha-Gal found in different foods. From that it looked like 2% milk would be safe, as well as most lower fat items. I thought dairy was a nutritional super food and I love all of it: cheeses, cottages cheese, 2% milk, sour cream. In trying to decrease the tongue reaction and occasional severe stomach pain that seems to be associated with dairy, I have eliminated all but occasional non-rennet (vegetarian) cheese. I had asked the allergist about this also and he said it would have to be an allergy to dairy, and not just from the alpha gal. He offered to test me again for it but I declined at that time.
Another major concern is medication safety. So many medications are contained in gelatin capsules or use gelatin or magnesium stearate as binding agents. This makes it so difficult to find truly safe products for us to use. I take a brand name medication that comes in a gel cap. I have to purchase vegetarian capsules and transfer the contents. This is pretty time consuming. I have been through my other meds, but I do still have some magnesium stearate in them. I am surprised at the lack of pharmacist support in prescribing and filling medications while avoiding allergens. I cannot even get my mail order pharmacy to record this allergy because it is not one of the more common to choose from. When my primary wanted to put me on a specialty injection, he just instructed me to go to the pharmacy and then let him know if it is safe for me to take. When I went to a pharmacy to discuss it, they pretty much just told me I had to call the company because that is all of the information that they would have. I have had a hospital procedure and felt safe because I had informed my coworkers and was able to enter my own allergies into the computer.
My general health and well-being I feel has suffered as well. I am diabetic and was being successful with a low carb diet prior to diagnosis. Eliminating all mammal and dairy from my diet really left me at a loss for the foods that I relied on for comfort, nutrition, and energy. I ended up eating pastas and vegan cookies to make up and that, of course, has not been a good thing. I’ve had two febrile illnesses last winter and one case of infectious colitis that I had to be hospitalized for. I tried to switch to an organic vitamin, but due to the colitis my doctor advised not having anything organic, so I have been leery to get back on another supplement. I have changed my toothpaste and mouthwash, but neither is the one that I feel is best as one that would be approved by the ADA. I have broken my first tooth. Between having reactions, and taking antihistamines to prevent, often I am so groggy in the morning, I can barely get out of bed. I have a hard time finding physician support for my chronic conditions (Chron’s, DM, psoriasis) because the doctors either do not understand the allergy or what symptoms are medical conditions vs manifestations of the allergy.
There is also a depression and isolation factor of this condition that is not addressed. My husband and I cook separate meals most nights. I bought my own grill. My children are out of the house, which is good to mean I no longer cook for them. But what we would be doing now is meeting up for a nice meal and I cannot do that. I enjoy cooking for big family events and spoiling them with home cooked meals anytime they visit. I cannot longer do much of that either. I cannot go out with friends and try new places, drinks, or ice creams. I cannot participate in work related events such as barbecues and holiday parties. I long to plan and take vacations to beaches and other countries but am fearful of the communication barriers and safe food preparation or emergency medical care. There is not much hope of getting better. And getting to eat my favorite foods. And it’s very difficult to avoid ticks. I’ve found 3 on me this year and I even did not go mushrooming.
Concerning what we need to do: Should this be tracked by the CDC? Yes! Why not? This is a condition that is only caused by the bite of a tick! Educate, educate, educate the public about tick illness prevention. I have seen many more general articles and sharing of posts related to this than in the past which is promising. Educate medical professionals! Primary care, nurse practitioners, specialists all need to know that if their patient is having hives of unknown origin, this is a possibility. They also need to know how to help us manage the condition, instead of just diagnose. Hospital staff need to know what types of medication and supplies to look for with possible allergens. There should be improved FDA guidelines for food labeling for food safety. The number one thing that should be disallowed is the use of the term “natural flavoring”. There should be clearer labeling, such as items that are advertised as chicken or turkey and come in a beef or pork collagen casing. Ideally, there will be a “contains no mammal” symbol or wording to help sort out those 52 ingredients we have to decipher on every label. Focus on increased funding for research related to how this sensitization occurs, fume reactions, or how we could be desensitized in the future.
Thank you so much for taking the time to read about my experience with Alpha-Gal Syndrome, and for working to improve the lives of all of the sufferers.
Kansas City, MO
Hello, first I would like to thank you for taking the time to read my story.
I am Alpha-Gal positive.
My journey with this began 15 years ago. I was in my late teens and started having random hive episodes and I have always been an outdoorsy person so tick bites were just a regular occurrence. At the time I was seeking medical help for normal teenage skin conditions so the hives blended in pretty well with other issues I was having, never even considered them being allergic reactions. Was diagnosed with skins condition and anxiety and the hives were just part of it.
Over the years there were periodical reactions always a few each year; some worse than others. Always would treat an attack with a antihistamine and a nap. Also, through those years I have terrible IBS, just thought it was normal and that was the life I had to get used to. Some years were better than others but I always had at least one hive attack and the IBS never went away.
Fast forward to fall of 2016, I started similar to a Paleo diet which if you are not familiar eliminates foods that cause inflammation. This was all a strategy to get a grasp of the terrible digestive issues that I was having.
Fast forward to early 2017, being my normal outdoorsy self, out and about in the freak warm early spring and got bit by yet another tick. This time it had a white dot on its back. Thought process was no big deal; been bitten by tons of ticks in my life.
Being on the diet I was, which was expensive enough, red meat was hardly in the diet. But ended up having some family over and we ate hamburger... well that night I got sick again... but something was different this time. I recently had seen a Facebook article shared about Alpha-gal, this time I had a suspicion. Made me remember a time in my teens where I had jasmine rice and steak for dinner and that night I got ill.... at the time I suspected it was the rice.
So with the suspicion in place about a red meat trigger, I had to do a little investigating on my own so I ate red meat... twice... and got sick.... twice....
Now with an actual idea a meatless diet was full in place, I was near almost paleo diet and red meat free.. when one day ate a bag of cheetos.... that right CHEETOS and got more sick than ever before full blown throat swelling anaphylaxis.
Aug of '17 i was finally able to get to an allergist and had blood work done and diagnosed alpha gal... finally after 15 years I had answers.
Since then the diet is in full force and I have been severe-reaction free.
After joining some forums I have learned that it is a lot harder than just cutting out red meat in your diet
Some people react to fumes or food additive and medications. It is a lot more than just a food allergy it’s an environment allergy, too.
What absolutely needs to happen is more educating - needs to be done in the medical field - too many Drs. that I have seen have no clue about this. Food products need to be plainly labeled like others as mammal products are everywhere and in everything.
Saint Louis MO
Dear members of the Tick-Borne Disease Working Group,
In 2011 while I was working on my doctorate in public health I contracted Ehrlichiosis. It was debilitating and I lost three months of my life. Later on I was diagnosed with Babesia and Lyme.
I strongly urge the TBDWG to include Alpha-gal Syndrome (AGS) and other “conditions” (including Ehrlichiosis, Anaplasmosis, STARI -Southern Tick-Associated Rash Illness, and Tick paralysis) in all education, research, and policy initiatives. These “conditions” which for various reasons do not meet the medical community’s definition of “disease” are in many cases debilitating, life-changing, and even fatal. How much more does it take to be considered important enough to be included?
As co-founder of Tick-borne Conditions United, we encourage the following:
- AGS and other "tick-borne conditions" (TBCs) should all be included in the US funded Tick-borne Disease research. The language in which the research is conducted should include AGS and other conditions.
- More education is needed about TBCs including AGS and its far reaching needs/support for the patient.
- Need for more protection in areas of discrimination with an employer, school, health and life insurance.
- Need to educate healthcare providers on better testing, diagnosis, treatments, etc. IE. Do NOT rely on CDC website as it was never meant to be used as a diagnostic health care tool or as a tool for insurance agencies to validate a claim.
- Need to include tick-borne conditions trainings in the medical schools and continuing education.
- Increase and improve public awareness on various ticks and associated conditions.
Thank you for your consideration of these comments.
Jennifer Platt, DrPH
Co-Founder, Tick-Borne Conditions United
The media shows "Lyme disease" and other tick-borne reports, however, they NEVER include anything on this deadly allergy, which is rapidly spreading across the United States. This is so hard for those of us with AG Allergy to understand why?!
Sadly, in the medical field, there are so MANY doctors, nurses, and ER hospitals that are not even aware of this life-threatening allergy; which is extremely dangerous and harmful to patients that must come to them for help with serious reactions from the allergy and can thereby medically be treated improperly. Many medications and vaccines have mammal ingredients and/or mammal by-products. Prescription drugs in gelatin capsules are made from animal fat, they can be extremely dangerous for all AG allergy sufferers. Heparin and heart valves are made from pig. It is NOT just a "Red Meat Allergy"
Additionally, it is very frightening that some in the medical field do not even believe the AG allergy is real and have refused to order the specific blood test for their patients..... UNBELIEVABLE!! I'm so thankful that my primary doctor (who never heard of the AG allergy and was unable to diagnose my symptoms after many tests) recommended an allergist.....fortunately for me, he was familiar with the Alpha-Gal allergy; as he has over 20 patients diagnosed with the allergy. Both adults and children are being affected by this serious allergy....the Lone Star ticks do not have favorites, they bite people of all ages!
Thank you for taking the time to read my story and how dangerous this allergy really is......It's not just as many believe....."Oh, she just can't eat a burger any more"....or..."a little bite won't hurt you"
St Louis, Missouri
Please view the attached links:
- https://www.facebook.com/alpha.gal (You will be astonished at the growing number of people that are affected by this allergy.)
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3545071/ (Anaphylaxis is a severe allergic reaction that can be rapidly progressing and fatal.)
- http://www.pharmacytimes.com/publications/issue/2015/may2015/alpha-gal-mammalian-meat-allergy-implications-for-pharmacists (Experts estimate that thousands of Americans have the alpha-gal allergy,7 with a causal relationship between lone star tick bites and these anaphylactic reactions.)
I am writing to you today to tell you my story and beg you to require companies to start listing ALL ingredients on their packaging.
In early 2000, after moving to our new home, I started experiencing allergic reactions. I did everything I was supposed to do, make an appointment with the doctor, explain what I had eaten before this happened. Well, 1st time was seafood at a local restaurant which is a common allergy. The 2nd time, I grilled chicken at home. The 3rd time was hamburgers.
I was sent to an allergist who did all kinds of tests. It came back that I wasn't allergic to anything. My doctor said I was either allergic to some kind of chemical or I had Idiopathic reactions. My doctor gave me a RX for an epi-pen, and told me to go to the ER if I use my pen. I had to go home and look up idiopathic.
I spent 14 years this way. Unexplained reactions, feeling tired all the time, joints and muscles constantly aching (I was in my late 30's early 40's!), afraid to eat anything, going on and off high blood pressure medications because my blood pressure would drop dramatically, almost to the point of passing out, for no reason, severe GI issues with pain, bloating, severe abdominal cramping, hot/cold clammy skin, almost passing out in the restroom several times because my blood pressure was dropping, dizziness, the list is too long to list everything.
Finally, in mid to late 2014, I ended up in the ER with severe diarrhea, vomiting, itching, hives, and passed out because my throat closed up. Unfortunately, the ER did not believe it was an allergic reaction despite the hives, throat closing up or passing out, so I was treated for food poisoning.
By this time, I have had 2 or 3 different panels of testing, numerous tubes of blood drawn, only to be told I was allergic to hazelnuts. I demanded my doctor to do more testing. My doctor drew blood, and was only looking for another nut allergy, but accidentally sent off a 2nd panel of tests which included the Alpha Gal Allergy IgE test.
I was in disbelief! How could anybody be allergic to mammal meat?! I started reading up on it. I was amazed, but I didn't really believe him myself. So, I continued to eat meat, and continued to have reactions. I finally just decided to try and not eat mammal meat and see what happened. Well, things got better. Not completely, but better.
I was still having very mild reactions and GI problems despite 2 colonoscopies that showed everything normal. I dealt with these reactions and the GI problems, until I found the Facebook group, Alpha Gal Support Non-Public. I could not believe that there were other people out there suffering like me. Through this group, I learned so many other mammal related things that were causing me to continue to have problems.
The first and most obvious one was dairy, but there were so many hidden things that I did not know was mammal. Why would my head itch every time I shampooed? Glycerin, which can be mammal or vegetable based, but most companies do not list it that way. And when trying to call some, not all, companies, they either do not respond, or will not tell you saying it is a part of the proprietary blend. I just want to know if it is mammal or vegetable based! Once again, the list is too extensive to list it all.
Then, my nightmare truly began. Grocery shopping which used to take about 1.5 hours would turn into a 3 or 4 hour trip, because I had to read EVERY label, and if I wasn't sure, I wouldn't purchase the product. My depression, after being off medications for 5 or 6 years, came back with a vengeance. I began to have major anxiety attacks just even thinking about grocery shopping. Many times, I would get so anxious or depressed while shopping, I would have tears just start streaming down my face and I would have to just leave my cart and walk out to come back and try again another day.
Finally, with the help of my new Facebook Group, Alpha Gal Support Non-public, and after learning as many of the "secret" code words that companies use for these things, I only have GI issues if I don't recognize one of the companies "secret" code words. I still read every label, but now I know what to look for, but the labeling of most companies is highly inadequate.
"Natural Flavors" is one of those items that needs to be changed. The definition of natural flavor under the Code of Federal Regulations is: “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional” (21CFR101.22).
Why is it that companies do not have to list EVERY SINGLE INGREDIENT?? If it's less than 2%, it's not listed, but it could still kill me. I am begging you to please start making ALL companies, food, health and beauty aides, pharmaceutical manufacturers, ALL of them to start listing ALL of their ingredients. OUR LIVES DEPEND ON IT!!
Rose Saulsbury, DAII, MDT
My Alpha Gal Story
I was bitten by a Lone Star tick in June of 2014. I was not aware of AG at the time, and I was more concerned about Lyme. I was pregnant with my 3rd child. The reason I remember this bite, 4 years later, is that it was so itchy, for months! It was on my upper back and it bothered me for months. I never had any issues with a bullseye rash and my OBGYN wasn't overly concerned with it. I went on to deliver a healthy baby in October and life continued.
I was offered a part time job at my older children's' school that Spring. I returned to work in March working two days a week. At that time, I was having a lot of stomach pain. No other symptoms, just pain across the top of my abdomen. I would try eating bland foods on the days I worked, but it never seemed to help. I had been lactose intolerant for years, but was able to tolerate cheese, yogurt or even some ice cream with a Lactaid pill, but no matter what dairy I cut out, I always had stomach pain. After months of pain, I finally went to my family Dr. thinking I had an issue with Gluten or some sort of GI issue. He ran all sorts of tests, blood-work, urine samples, and could find nothing wrong with me.
Life with three kids does not allow you a lot of time to really focus on yourself, so I handled the pain the best as I could, but I knew something was wrong. I blamed mold, gluten, stress, but nothing really helped. I became pregnant again in Spring of 2016 and delivered another healthy baby boy in January 2017. By the summer of 2017, I was having constant pain as well as severe bloating. I had lost all the baby weight, and some, being the skinniest I had ever been, even skinnier than high school, I was 35 at the time. My joints ached constantly, I felt like I couldn't remember anything, and I would be so bloated by the end of the evening, I looked 6 months pregnant. I had horrible gas and would get short of breath at random times. My fingers and toes would randomly go numb. The worst reaction I had was when we went to a local farm for fresh ice cream. I took a Lactaid pill and ate ice cream, like I always had. I felt like I was going to die on the drive home. I began keeping a food journal that Summer and quickly saw the connection between dairy and some of my symptoms.
I cut out most dairy, and saw some improvement, but I was still not 100% normal. That August my father died unexpectedly of a heart attack and my life as I knew it stopped for a while. In November, my husband practically dragged me to the Dr. to figure out what was wrong. I had no energy and constantly was in pain and seemed to be reacting to whatever I ate. She had an excuse for everything. Headaches - dehydrated. Achey joints and numb fingers - nursing a baby, carrying a baby, having 4 kids. Shortness of breath - exercise more. Rapid heartbeat - Too much coffee. Stomach pain - IBS, eat a low FODMAP diet. She did test me for Food Allergies and my panel came back as allergic moderately to Dairy, Beef and Pork. She did not mention a thing about Alpha-Gal. Just avoid those foods, eat low FODMAP and come back if you still have issues.
At that point, my husband flat out told me I had Alpha-Gal. He had heard of it from a co-worker, who had a friend with the same symptoms as me. I didn't believe it because I had no anaphylactic reactions. I hadn't heard of the GI side of it. I started cutting out those foods, but still would have some cheese, or a little bit of ham, and sure enough I still felt like crap. I bought goat cheese for a Christmas party. I was so sick within 30 minutes of eating it. I was convinced I had leaky gut and I needed to heal my gut - with Beef Bone Broth - Wow did THAT make me sick.
I had joined a FODMAP group on Facebook and I brought up my food allergy panel and someone said I hate to scare you but I had the same thing, and I have Alpha Gal. I called my Dr. in April 2018 to test me and sure enough, we found out what my problem was.
I have cut out all mammal products and I feel fantastic. I am gaining weight - back up to a healthy weight), I have no more bloating and the joint pain and finger numbness went away. I try to tell everyone I know about Alpha Gal and what to look out for.
My husband has alpha-gal syndrome. He’s probably had this allergy for numerous years, but we didn’t know what the allergens were.
He has always been a meatatarian. In 2015, he started having chest pains and shortness of breath. We discovered he had blockage in two of his arteries in his heart. He underwent a procedure to insert a stent in his heart.
I, as a health conscious vegan spouse, advised him to restrict his red meat consumption. He still ate pork and dairy.
On August 28, 2016, we were in North Carolina celebrating his birthday. And because it was his birthday, he grilled a steak for dinner. Later that night he developed raging red hives from head to toe, so he hopped into the shower. I found him bent over, almost unconscious. He came around quickly, so I got him in to bed. The following morning we woke up to two puppies wanting to go outside. My husband, Tony, went downstairs in the rented home to take the dogs out. A few minutes later I came downstairs to find him face down in a pool of blood. He passed out and split his head open. He spent the night in the hospital there in North Carolina. The doctors didn’t know what caused the reaction. We suspected it was an allergy to a red dye injected into the steak to make it look fresh. We also suspected it could have been an allergy to an undisclosed ingredient in onion or garlic powder.
Fast forward to this year. He had a reaction to a pork chop. He finally went to see the local allergist, who confirmed the alpha-gal allergy.
Tony has a knee condition that causes pain. His physician prescribed a pain killer. The pharmacist confirmed it to be safe. But it was a gelatin capsule so it wasn’t safe. And neither of them yet knew that! We researched a safe over the counter pain killer. Guess what, we couldn’t find one in the US. We had to order one from the UK.
On Friday, July 20, 2018, my husband called me to say the he was headed to the hospital. He had been experiencing severe back pain. It turns out he has two kidney stones. This condition causes the most severe pain imaginable.
Most of the staff at the hospital had never heard of alpha-gal syndrome. His ER physician had only known it as the red meat allergy, so at first he wasn’t aware. I showed the doctor a list of safe pain medications and the specific laboratory that manufactures it. He left the room, researched alpha-gal and the medication. The hospital didn’t have that specific pain killer. So he handed me the prescription and said “good luck”. While waiting for my husband to be discharged, I started calling local pharmacies to find the medication. I didn’t have any luck. We left the hospital and went to more pharmacies, but still no luck. It was very scary coming home without any pain medication that would deal with that much pain.
We went to a compounding pharmacy about an hour away from our home the next day. The pharmacist there was able to make a pain medication for my husband that was safe for him to take. We have yet to find out if the insurance company will even cover this.
Did you know that natural flavoring can contain animal ingredients that can kill my husband? Did you know that our laws are such that if an ingredient is so minimal that it doesn’t need to be listed? But that ingredient can kill someone with alpha-gal.
We are forced to contact each individual company to inquire about the ingredients. Imagine being allergic to your toothpaste, deodorant, crackers, bread, even a cookout at your neighbor’s backyard.
Alpha-gal is a tick borne allergy, and it is on the rise. It can cause a reaction from sitting in a restaurant that is grilling meat, from washing your hands with an unsafe soap, or eating a meal in a restaurant that cross contaminates.
Imagine being in a terrible car accident, and being allergic to every pain medication that the EMT’s carry in the ambulance. Does the EMT have any direct training about alpha-gal? No. They actually could kill him with their treatment. And then you arrive at the hospital where there still is no safe medication.
I have to ask, why in the world is pork or beef in a pain killer? Why have we allowed this industry to dominate our food and medicine?
We need more awareness, and we need more labeling for this allergy. We need the FDA to get animal ingredients out of our medications!
Please, as a tax paying citizen, I implore you to change the food industry labeling habits. Peanut allergies are recognized as deadly, this allergy needs to be listed as such also.
Thank you for your time and consideration.
In 2016, I tested positive for Alpha Gal or galactose-alpha-1,3- galactose or "the meat allergy" as it's often referred to (And incidentally, a misnomer.) I endured 9 months of sickness (extreme fatigue, horrid joint pain, exhaustion) and had countless doctor visits prior to diagnosis. I was told I had narcolepsy, a heart murmur (I do not) fibromyalgia, and was prescribed anxiety and antidepressant medications, all of which--unbeknownst to me--I was allergic to. I've been told I'm crazy, been looked at like I'm a pitiful and been told I need to "introduce mammal back into my diet."
After my long journey, I was told by my diagnosing allergist I "probably didn't have Alpha Gal" because I "didn't react to pork," but that she's test me because I'd asked for it. The test was positive. When I tried to contact the Missouri Department of Health and Human Services (they track erlichosis, ricksetta, Lymes but no Alpha Gal) I was told they don't track Alpha Gal because it's "not communicable."
I now have to pay $300 a month on compounded meds because if they aren't made without dairy and mammal byproducts, I get very ill. I must also pay $137 every 2 weeks for cromolyn sodium (on top of what my insurance covers) because I developed Mast Cell Disorder and became allergic to the fumes of cooking/cooked meat and cheese. After being in the same ROOM as a freshly cooked pizza, I went into anaphylaxis and I was rushed by ambulance to a local hospital where I had to explain....to the third ER doc... what was happening. None of them had ever heard of Alpha Gal.
This is so much more than meat. I've developed secondary allergies that have made me allergic to the dye in polyester and have to wear completely cotton long johns under my work uniform. I cannot wear leather. All my personal products are vegan. I have to call the companies of every single thing I eat, drink or medication I take to see if it's safe because a label that says "natural ingredients" can contain any form of mammal. My prescriptions have to be vetted to determine if they're safe, which usually takes 2-3 days at minimum and because companies do not reveal mammal sources in labeling, even to pharmacists. And if I need a shot? An injection? I don't know what will happen if I need one quickly, as many contain gelatin. What would I do during a separate life-threatening incident? Play Alpha Gal roulette with my medicine? What would a doctor do if I was incapacitated? I wear a medical alert bracelet on case I pass out, so medical personnel don’t think I'm a drug addict.
I can't eat out very often due to cross contamination. I eat my food cold at work, because I cannot control who puts what in the microwave and I have gotten ill from cross contamination at work.
Please, please track Alpha Gal. Please consider our (unfortunate) growing numbers. Please know that the medical community--including allergists--is horribly uninformed on this. So much so, I fly once a year to see Dr. Scott Commins with the University of North Carolina, Chapel Hill. He has been the only one to help me, that believes me.
Thank you for your time.
I want to begin my letter by saying thank you for your interest in tick borne illnesses. In 2016, I was diagnosed with Alpha Gal, a tick borne allergy to mammalian meat. Prior to that date, I had never given tick borne illnesses much thought. Sure, I had heard of Lyme and Rocky Mountain Spotted Fever, but I never feared I would get these rare diseases. They seemed like someone else's problem. Fast forward to today, and I find myself incredibly grateful that there are those of you who have more forethought than I did. So thank you for your interest, time, dedication, and hard work in helping those of us who have contracted illnesses and preventing others from suffering.
The beginning of my story is very similar to many people with AG. I was bitten by a tick (several actually-I live in a wooded area in NC), and I woke up in the middle of the night having a violent allergic reaction to an unknown cause. Unlike many people who develop AG, I live in an area ripe with educated doctors from some of the best medical systems in the country, and I thankfully had only one visit to a doctor who quickly knew what I had and diagnosed me. I immediately gave up mammalian meat, but my symptoms continued. I developed an allergy to dairy. I developed inhalation reactions meaning I could not be in the same room as mammalian meat cooking. I began learning more and more about the mammal that is in the foods we eat, but labeled as other products. The mammal that is in our medicines, our shampoo, our candles, everywhere. The world became a minefield for me, and I spent most days in terror waiting for my tongue to swell, my airway to close up.
The year of 2017 was a difficult year for me as I continued to try to solve the mystery of my allergy. I continued to have reactions to random foods and products. This allergy was altering my body in ways I could not understand. I took Benadryl almost every day, which meant I slept parts of my days away. My family not only gave up the foods that they loved, but they learned to live with a mother who was sick, who felt bad most days. They worried constantly. They learned how to use an Epi Pen if their mother passed out in front of them.
Now in 2018 I have a better handle on my allergy, but I continue to have secondary health issues caused by either my allergy or the many medications I take every day to try to control it (3 Allegra, mast cell stabilizer, Xolair injections). I went from being a perfectly healthy 36 year old woman, to not being able to exercise, have the energy to play with my kids, eat in a restaurant, walk into my children's school without checking what the cafeteria is cooking, eat a home cooked meal with my mother without her fearing she is going to make me sick, and so much more. To say AG has changed my life is an understatement.
The problem many of us with AG are facing is that there is no research to back up what we are experiencing. Although I am able to see one of the leading AG doctors in the country, there is no research to back up what I am telling him. He is treating me in the moment the best he can, but so many of us see doctors who are not familiar with AG or worse yet, don't believe it exists. The need for research on both the cause and treatment as well as doctor education is imperative and the time is critical. This illness is rapidly spreading, and our doctors are not prepared to treat it.
I read article after article that describes this allergy as simply an allergy to mammalian meat that can be controlled by simply avoiding said meat. But for so many of us, it just has not been that easy. We are sick. Our lives are turned upside down. Not because we don't get to eat a steak anymore, but because we live in constant fear of cross contamination, hidden byproducts, well-meaning friends who don't know gelatin is made from mammal, and fumes lingering from the cafeteria down the hall. There is no part of my life that AG has not changed or touched.
Again, thank you for taking the time to read my letter and for your diligence to address not only AG, but all of the tick borne illnesses. I am incredibly grateful for each of you.
I would like to be included in your long list of individuals that have alpha gal. Reason being is, that this seems to be more and more of an issue. And I feel the need for someone to work on a cure for this allergy, that is caused by a tick bite.
Moreover, there are a lot of people I speak with in my area with symptoms of Alpha Gal that do not have the financial means to get tested for Alpha Gal. It would be nice to see a mass testing made available. That would help initiate how many more individuals test positive for Alpha Gal, and initiate funds for research for a cure.
I will keep my letter brief.
I am located in Arkansas. More specifically Conway, Arkansas. I was not aware of my condition, until I was actually tested by an allergy doctor. However I did have symptoms 10 years prior to the test. I was incredibly sick and had to go to the hospital emergency room on several occasions. My stomach was in extreme pain and I broke out in hives from head to toe. My eyes swelled shut. Along with slight closure of the throat. I also went into some sort of convulsions, perhaps some sort of shock. The pain is excruciating.
Fast forward three years after diagnosis. I have avoided all red meat. And have been able to keep the symptoms under control. With this exception of drinking milk. I have to keep my consumption of dairy products to a minimum.
I do not recall a tick bite, where I got bit or what location I was at. However, if I was to give it my best guess, it would have occurred in Ferndale, Arkansas, directly off of Congo Ferndale Road. Which at the time was a rural area.
Thank you for your time.
When my son was around the age of 9, he was bitten by a tick on our lake property in Arkansas. No big deal, right? Tick bites are common. They itch, we get over them, life goes on… I had no idea how wrong that way of thinking was.
After several weeks, the bite hadn’t healed so I took him to his Pediatrician. His Pediatrician gave me a lesson on how to properly remove ticks, told me to put an anti-itch cream on the area and assured me it would heal eventually. Over the next couple of years I took my son to the Dr. for what seemed like constant diarrhea and/or hives. His Dr. would tell me that maybe my son had a nervous stomach or the hives were likely caused by urticaria and that he might eventually grow out of it.
One evening, my son, who had been outside playing, came home with a swollen lip. I gave him ice, thinking he bumped it playing basketball with the neighbor kids, and didn’t think much about it. At around midnight, he woke my husband and I with the biggest swollen lips, cheeks and neck. Upon arriving at the ER, they quickly treated him for severe angioedema but had no answers to the cause. Upon release from the ER, after several hours of observation, they told us to see an allergist whereupon he was diagnosed with Alpha-Gal Syndrome. I am confident that if his allergist hadn’t already been well acquainted with AGS, he wouldn’t have been properly diagnosed.
Since diagnosis, I have worked hard researching products that are safe for my son. At first it was incredibly hard. I felt I was the only one in the world who had a child who couldn’t pick shampoo or chapstick, etc. off the drug store shelf without causing some form of anaphylaxis. I have spent hours upon hours over the last few years researching, calling manufacturers, looking for some form of normalcy in regards to everyday household items for my kiddo. I have also spent many tearful hours trying to inform Drs., nurses, pharmacists of AGS while my son was in the throes of the flu or a stomach virus.
I have had to tell every Dr. that we’ve come into contact with since my son’s diagnosis that he has Alpha-Gal. Despite every Dr. being a part of the same network.
To this day (after several years), his chart says beef & pork allergy, it does not say Alpha-Gal despite my efforts to get them to add it to his chart.
I tried adding AGS to my son’s chart online, there is no option to select AGS in the drop down menu.
AGS is so much more than just a beef and pork allergy. There are so many reasons that AGS needs to be added to his chart if for no other reason than understanding that he can’t be given certain medications. And to go further, first responders, ER staff, etc., need to be fully aware of what AGS means when it shows up on a patient’s chart or on a med alert bracelet. There needs to be some sort of database for AG safe products/medications in the medical field.
When my son has seen a Dr. in the past, he has received staples in his scalp with no anesthesia. In addition, we have:
- Waited 4 weeks to hear from the dentist to find out if his research came up with a viable option for numbing before fillings
- Been turned away with no treatment because the Dr “didn’t know what medications were safe”
- Waited up to two weeks to get responses from manufacturers before my son was treated
- Been sent home with prescriptions that are harmful
- Been given inserts to the HPV vaccine to find out on my own if my son could receive the vaccine (the answer was no)
- Bold the pharmacist was too busy to research a medication for me
- Been given a prescription and told to do the research on my own, let them know if they need to try something else
We have personally given published articles to physicians while in their office to help “prove” AGS and/or to help with the learning process and been told they “just didn’t know what to make of it”.
I put the health of my son at the mercy of these medical professionals who have absolutely no idea how to treat my son.
These issues are in addition to what he faces on a personal level. Nevermind suffering from severe acne because there’s nothing he can use or take to fight it. Nevermind that he misses out on team potlucks and after race meals. Nevermind his friend’s parents are afraid to have him over for liability reasons. Nevermind that we live in constant fear of him getting injured or having a life threatening illness that can only be treated by medications that contain mammal byproducts.
My sister once asked me “what happens if he’s in a wreck? They’re not going to just not treat him because of AGS so what would they do?” I could not give her an answer.
These are every day problems & fears that we live our lives around. This cannot be forever. This cannot be accepted as a normal. This cannot be ignored any longer.
Thank you for your time and consideration.
This week I missed three days of work. I've dealt with everything from bronchitis to hives to G.I. upset...from ripping out drywall. I was doing some work on the house that lead to a week-long systemic allergic reaction because I did not think about the fact that drywall has mammal in it. The thing is...alpha gal is found in not just mammal meat, but also mammal byproducts and just about every daily use product one can think of. I can't wear a wool sweater or sit in a leather chair. I can't eat candy, jello or take medications with gelatin capsules or magnesium stearate (go ahead and check your medicine cabinet...nearly all medicines contain magnesium stearate). Cheese comes from mammal so does dairy. Many ingredients such as whey, enzymes, and natural flavors are in just about every processed food. There are not labeling rules that makes companies put “May contain mammal" on their ingredient labels. I've had to change my shampoo, soap, toothpaste, lotion, etc. to vegan products. There are medical implications, too...I can't take heparin if I have surgery or a blood clot because it comes from mammals so I wear a medic alert bracelet and cross my fingers that first responders, ER personnel, and doctors know what it is and don't inject me with something that could potentially kill me. BENADRYL has mammal in it!. If I get bitten by a snake, I can’t have the anti-venom because it contains mammal. It's more than just red meat or more than just hives and a tummy ache...this is a LIFE-THREATENING allergy! People go into anaphylaxis...throats close up, blood pressure drops, bodies swell. We carry epi-pens! THIS COULD KILL US. SO, before you say he's better off without meat, or "man I would just die if I couldn't eat my steak"...keep in mind, for us, we might just due if we have it! IT IS A LIFE CHANGING ALLERGY. I have to call the manufacturer for EVERY cold medicine, antibiotic, vitamin, etc. that I might need. I'll need to search for vegan sunscreen I'm allergic to the medication that can help me if I do have a reaction (benadryl has mammal in it). Children may need to eat their lunch with the teacher because they can’t be in the cafeteria with the meat fumes. Teenagers can’t go kissing their beau without first checking to see if they have eaten meat recently. It has already affected my job because I have to leave the building every time a coworker heats up their lunch in the microwave (fumes from meat cooking carries the alpha gal molecule into airborne particles that we inhale). They offered me a part-time position. I was the director! Now, I might lose my house. I can't pet my dog. I have a violent reaction if he farts in the room I'm in. I can’t kiss my husband if he’s eaten a cheeseburger recently. Even vegan products aren't always safe because many times they contain carageenan which is nearly identical in molecular structure to alpha gal and the body mistakes it for alpha gal and we react to that. I can’t go to a friend’s barbecue, even if I don’t eat (because fumes). I have to wear an N95 quality respirator mask to the grocery store because the deli cooks ribs every day. I can’t eat at restaurants because of cross-contamination or fumes risks. I would NEVER have been able to eat in the restaurant that was featured in this story. The fumes from the cooking meat would have made me pass out on the floor. I can't put on CHAPSTICK! I can’t wear band aids because of the glue in the sticky part. Please don't downplay this story as a minor inconvenience. It has severe medical, physical, social, emotional and financial implications that change our lives and the lives of our loved ones. ...and with all that said, TURKEY BACON SUCKS! I would like to see this allergy test become a routine part of a diagnosis differential when seeing patients with idiopathic anaphylaxis, idiopathic hives, tick panels, etc. I would like to see ALL doctors, dentists, AND PHARMACISTS educated about alpha gal allergy. I would like to see the CDC require reporting of this allergy so that it can be better tracked and researched. I WOULD LIKE ALLERGY WARNING ON MY FOOD, MEDICINES, AND PRODUCTS!! How bad will we ALL be when do many people are doing without vaccines they need because they are allergic to them. What about public health? Please fund research. Research is now showing that people with alpha-gal allergy have 5x more arterial plaque in their hearts. Heart disease caused by a tick!?
Alpha Gal allergy from the Lone Star Tick
Those of us afflicted with this allergy need awareness spread, and need help with food and medicine labeling and warnings. As you read this, please think about how you would feel if this were you or your child. Please take a few minutes to read this! Thank you! This allergy is spreading rapidly.
I was diagnosed with the alpha gal allergy after an almost anaphylactic reaction to a hamburger I ate on July 4th, 2017. In the typical 3 hours (can be up to 6 or 8) after I ate the hamburger, I was covered in whole body huge hives and my throat became hot and tight, so it meant a trip to the emergency room, fast treatment, and thankfully, I was OK. I thought I could deal without having beef or pork, but then I learned how very life-changing this allergy is. Before July 4th, I had no idea I had the allergy. I had had a tick bite a few weeks before, but didn't know about the Lone Star tick.
Even finding out you have this allergy can be a near death experience. Many people, including me, go into anaphylaxis, or near-anaphylaxis. Some people have died. This tick-borne disease is spreading rapidly. Two of my friends have been diagnosed in the past month.
This allergy is truly life-changing because mammalian products are in so many processed foods, medicines, and even things used in hospitals. I am also allergic to dairy, because it is from a mammal, of course. My life now means reading every label on food, medicine, shampoo, lotions, soaps, you name it. Your entire everyday life is changed for the length of time you have this allergy, which can be a lifetime. Living with this is depressing and changes everything about your life, and you may or may not recover from this allergy in your lifetime. It isn't safe to 'experiment' and see if something bothers you, because you could end up with a life-threatening reaction.
Eating in restaurants is like playing Russian Roulette, so I have only been out twice in over a year. You have to talk to the chef/manager and be sure your food is safe, and that is has been cooked separately, with separate and clean pans and utensils. This is damaging to your social life. I have become the 'If I didn't make it, or don't know every ingredient, I can't eat it' girl. Food isn't fun anymore. Doing without dairy is actually the hardest part, and substitutes are just not the same. I couldn't even eat fried chicken at a funeral reception recently because I could not find out what kind of fat the chicken was fried in. I have to check everything!!
Food products in stores need to be labeled clearly so we can see if they are safe. 'Natural flavoring' can often have mammal products, and there are other hidden additives which can be dangerous. Even sugar is sometimes processed through bone char. You can see how difficult this all becomes.
Medicines are often made with gelatin capsules, so finding vegetarian capsules for the things you need can be a problem. And some medicines and supplements are derived from mammal products. Those of us with this allergy need to be able to tell what is safe for us. Again, I have to study every label on everything, and I am becoming a chemist!
Most vaccines have mammalian products in them. Again, this makes life difficult! We need clear identification there, too.
I had a CT scan with contrast recently, and had to ask the ingredients in the contrast before I would consent to the procedure. You have to check everything you are given or treated with in a hospital. If you are not able to communicate, you need a family member there who knows about your allergy and who will advocate for you.
Please do whatever is within your power to make life easier for those of us with this life-threatening allergy. It is not an easy life now.
On June 22, 2018, I was diagnosed with the Alpha-Gal allergy. My symptoms began two years ago, shortly after moving to Oklahoma. I was bitten by two ticks within a week of arriving and about 1-2 weeks later had my first outbreak with hives. For two years, I have gone to numerous doctors, kept food logs and activity logs, but to no avail. The doctors did not think it was a food allergy, due to it not occurring relatively quickly after eating and because the hives did not occur for hours after eating and because it did not happen every time I ate. Ultimately, each one just told me to continue to use Benedryl to treat the symptoms and to come back if they worsened. Unbeknownst to me until recently, I discovered that I had many other symptoms that occur with Alpha-Gal, such has gastrointestinal distress, headaches, extreme fatigue, shortness of breath, and low blood pressure, just to name a few. It was almost two years to the day of my first tick bites that I got bitten by two more ticks. That is when everything went severely downhill, with reactions occurring almost nightly. On May 22, 2018, I had my first episode with passing out, coughing, could not breath, covered in hives from head to toe, severe swelling, and my blood pressure was extremely low. A trip to the emergency room entailed being given IV Prednisone, IV Benedryl, a breathing treatment, and so much more. Many hours later, I was released to go home, but it took a little more than a week to recuperate, still taking oral Prednisone, Benedryl, Zyrtec, Zantac, and Flonase. It was a terrifying experience for me and my family, so I knew I had to get answers, one way or the other. It was then that I went to an Allergist in Texas that began with a complete and in depth medical history, many questions regarding reactions, foods, environment, home life, and so much more. She began with the food skin test, which I had to stop all antihistamines for 7 days prior, (one of the hardest things to do, when you are having reactions almost nightly) many, many, many blood test, CT scans of the sinuses, and then the Environmental skin test. My food skin test indicated a severe allergy to meat and milk/dairy, but it was as I told the doctor, if I am allergic to this, why am I not having reactions each time I consume it? We could not figure it out! It wasn't until my niece told me about the Alpha-Gal allergy from a tick bite that her son had been diagnosed with about a year ago, his symptoms, and how he also did not react all the time, that I requested that I be tested by my allergist. Even at that time, she stated that I would react every time, but upon me insisting, she did do the blood work. She contacted me on June 22nd to tell me that I did, in fact, have the Alpha-Gal Allergy. A person is supposed to be < .035 and mine registered >100. My doctor informed me that I was the first of her patients to be diagnosed with Alpha-Gal. She also informed me that although she was not familiar with it, she would be doing extensive research and encouraged me to do the same. She assured me that we would get through this together. She phoned me multiple times over the next few days and passed on information regarding gelatin, medications, vaccines, and advised me to contact my pharmacist to request that he review all my medications and ensure they were safe for me to consume. Of course, on the day of being diagnosed, she informed me to go off of all Mammal red meats and all milk products, immediately. At this time, she was not even aware of how much more extensive this would prove to be, such as the risk for cross-contamination at home and at restaurants, as well as, all the many different ways manufacturers hide or disguise animal by-products with all the deceptive terminology like "Natural Flavoring" or it's not listed on the ingredient list at all, as with many spices. This has truly been a life altering experience and I believe it will continue to be for a very long time, until I have mastered what is "SAFE" for ME. Reactions are still occurring frequently and each one now seems to be a little different and more severe.
Now, I would like to share with you a recent incident that occurred to me at an appointment with an allergist in Texas, after my diagnosis of Alpha-Gal. Just to clarify, this is another physician at the same practice, but NOT the one that diagnosed me, as she left the practice and moved out of state. Anyway, this was the most horrible and humiliating experience that I have ever had at the hands of a doctor. From the moment this doctor entered the room and looked at my chart and saw that my former doctor had diagnosed me with Alpha-Gal, he began to patronize, belittle, and humiliate me all at the same time. According to him, Alpha-Gal is just a made-up name for a normal meat allergy, there is no correlation to milk/dairy with animal by-products, and the Alpha-Gal test is just an expensive and unnecessary test for a common meat allergy. He stated that if I have problems with dairy, it just means that I am probably lactose intolerant and he can give me some pills for that. He said that I was full of nonsense when I told him that I do not react every time and that I do not react for several hours. He would not listen to any research or information that I was trying to impart to him, even though I was trying to explain about mammal red meats and how they affected me. In fact, he was trying to tell me that a chicken and other poultry were mammals and that if I was telling him that I had to stop eating beef and pork, then I need to stop eating poultry and eggs, because it is a mammal, too. So, at the conclusion of this appointment, I was informed that I needed to eat meat and dairy, as I always would have, and to stop with all this nonsense, that it was all in my head. When I informed him that if I did that, I would go into anaphylactic shock, his response was to ask if I had an EpiPen? When I told him "yes", he told me that if I was to react, because I thought I had a meat allergy, then use the EpiPen and go on with my life. His last statement was to let me know that if I had any further problems, then I needed to go see my primary care doctor, because there was nothing more he could do for me. I told him that I felt sorry for a person that could not be open to something new and do some research to learn more about the allergy, instead of degrading his patient and former colleague. His response to that was to tell me that he was sorry if I didn't like what I heard, but sometimes the truth hurt.
I told you my story in the hopes that you will understand the struggle that AG sufferers go through, to not only get a diagnosis, but to also find a doctor that is familiar and willing to do some research, not only for the patient, but to educate him/her so that another patient will not have to go through what the one before them did. It is horrifying, when you FINALLY get a diagnosis, only to be told by a doctor that it is all in your head, ridiculous, and that you are full of nonsense. What is even more horrible is that IF I had not already researched and was familiar with the AG Allergy, then it is a good possibility that I would have walked out of that office and would do exactly what he said to do. That doctor could have KILLED me and I hope that by writing this we can stop him and others like him, from harming or killing any innocent person. Please push to get more facts and information to the doctors, pharmacist, and hospitals and please push to include ALL ingredients on food labels, regardless of the minute amount in the ingredients. That small amount could mean the difference between life and death for a person that suffers from the Alpha-Gal Allergy.
Thank you for your time,
I was driving down interstate 95 headed out of Georgia on my second day of driving from Virginia to Florida. In the back seat were my 11 and 13 year old. We had stopped at one of the last exits available that offered food and restrooms before miles of nothing. We went inside to the expansive food court and as I waited in line at two different places before I sat down with the kids while they ate. I was smart! I was not going to eat ANYTHING in that place! “Russian Roulette- AG style” would be a BAD idea on the road.
Once they were done we got back in the car and headed south. Maybe ten minutes down the road, in midafternoon sun, I began to struggle. I could barely keep my head up and eyes open. I remember thinking I need to pull off the road. I didn't notice crossing the state line. Nor did I notice anything until the signs for Jacksonville which is about 30 minutes into the state. That was the last time I drove to Florida. It was not until recently, that I made the potential link to a fume reaction.
Backing up to 2015. A trip to the state park for an evening concert earned me the rare opportunity to develop an allergy to, pretty much, the only things I eat. Within weeks of the bite, I woke up early around 2 a.m., I nearly didn't make it to the bathroom. Despite years of living with migraines, and having been ill in the most unfortunate times and places, nothing compared to the violent reaction that was about to become my new norm,
Always in the middle of the night, even if the offending meal was at noon, and always lasting for hours, these incidents were always accompanied by fear of death, racing heart, an instant weakness in the limbs, and an inability to hold myself up, This happened countless times over 9 months before I realized that it was always after eating beef or pork,
So, I stopped eating my favorite things. Then I found myself on a midnight train from Boston to Virginia, alone and begging the off duty food car attendant for plastic bags, huddling in the corner of the empty handicapped spaces when the bathroom was occupied. What a nightmare. Why was this happening?
It wouldn't be long before I realized cross contact was also a significant threat. One drop of pepperoni grease would cause this nightmare. There was always a sign that it was coming, so I began to panic when that harbinger of doom appeared. No one understood. How could I know that I would be sick in the middle of the night, and maybe if you take some alka-seltzer or something, and why are you crying over this? I heard it all.
Then one day, I tell my doctor again, that something weird was going on. He told me to call if it happened that weekend. My white blood cell was high and he was concerned, so when I woke up that Saturday sick, he sent me to the ER. Was in the hospital for 2 nights, had multiple tests and left feeling worse than when I went in.
Within 2 months my gall bladder was removed and I STILL got sick!I discovered an article about Dr. Platts Mills and I joined a Facebook group. Finally I was getting answers.
Since then I have reacted to fumes from candles, salon chemicals, and cooking beef, even severe stress. Chest pains, bp drops, and racing heart. It’s hard narrowing things down especially having had hypothyroid since I was 16. Exhaustion is much worse now,
This condition is more than just getting sick after an exposure, or having hives. It’s isolating, and makes keeping friends hard. You find out who in your family truly supports you and who doesn't. Going out anywhere can be depressing instead of exciting. Trips to the grocery store can lead to a confusing and overwhelming waste of time, when making decisions seems impossible and you find you can’t even muster the energy or will to find what’s on the list for the family, not just myself!
I know mine is not the worst case. I know there are many who have dealt with so much worse. However, not knowing what could happen from one day to the next can make even the least reactive people fear.
Thank you for your time.
Unable to attend a planned meeting in Colorado of the CDC with Lyme patient representatives on June 11, 2013, I gave this speech to the meeting by speakerphone.
Hello. My name is Kathy White. I had a stroke 12 days ago and am talking to you from my hospital room in Kansas. I got a tick bite in 1998 in Kansas City, Kansas, while I was supervising recess in a grassy area of a schoolyard. I got Lyme disease and babesia and have been sick ever since. I had to quit my teaching job. For the past 14 years, I have been an officer of the Lyme Association of Greater Kansas City. Our organization was formed in 1993. We serve people throughout Missouri and Kansas and also other states. We publish a brochure and a monthly newsletter. We give information to patients, the public, and medical professionals, and education packets to schools. We cooperate with the efforts of the LDA. A major concern of ours is difficulty getting diagnosed and treated. Most doctors in our area are unable to diagnose and treat us or refuse to do so.
There are 3 aspects of Lyme disease prevention: (1) preventing tick bites, (2) preventing early Lyme disease with antibiotics immediately after a tick bite, and (3) preventing the disease from becoming chronic. (1) Many tick bites could be prevented by controlling the deer population, using safe pesticides, and using permethrin on clothing. (2 & 3) The CDC can easily prevent many cases of early Lyme and chronic Lyme by making doctors aware that Lyme is in every state, by encouraging prompt and adequate treatment on the CDC website, and by dropping their website link to the IDSA treatment guidelines and creating a link to the ILADS guidelines instead.
The CDC is funded by taxpayers in all 50 states. Therefore, its employees should care about Lyme disease victims in all 50 states, not just the Northeast. The CDC should work for everybody. Statements on the website mislead doctors in most states into thinking that Lyme disease is just in the Northeast and Upper Midwest and not in their state. This causes many doctors to fail to diagnose it and even to refuse to test for it. If a patient does persuade a doctor to give the test, and the test is positive, the doctor often says, “Your test was a false positive, because we don’t have Lyme disease here.” One patient in St. Louis was told, “Our hospital has had a number of false positive tests lately.” The statements on the CDC website that say Lyme disease is mostly in the NE and Upper Midwest should be revised to say that, although most reports are in the NE & Upper Midwest, Lyme is actually in all 50 states, but it is vastly underdiagnosed and underreported in most states.
Support groups have helped thousands of patients whose cases did not get reported, even if they met reporting criteria. Many people in Missouri, Kansas, and other states are going from doctor to doctor for many years before they finally get diagnosed. Even at this late date, most people improve with long-term antibiotic treatment. There are many stories of children who missed years of school, but after lengthy treatment managed to get a GED and attend college. Long-term treatment is getting children out of bed and out of their wheelchairs.
The CDC should quit endorsing the ELISA test. It misses far too many cases and causes people to become disabled from lack of a diagnosis.
The CDC website says that ticks should be removed with tweezers, and it discourages the use of tick removers. This is unwise. Researchers at Ohio State University found that tick removers that slide under a tick are superior to tweezers for removing the tiny nymphs and do a better job of getting all the mouthparts out and most of the cement. Wherever tweezers are mentioned, the website should say “fine-pointed tweezers.” It is very difficult to remove the tiny ticks with tweezers without squeezing the gut. Many people have developed Lyme disease after a tick was removed with tweezers, even if the tick was attached only a short time. It does not take at least 24 hours for a tick to transmit Lyme disease. Although most ticks take about that long or longer, many people are becoming infected in less time than that. Dr. Willy Burgdorfer said at a Lyme disease conference at Bard College in 1999 that about 5-10% of ticks that are carrying Lyme disease have a systemic infection and have the disease in their saliva and can transmit it as soon as they bite. He said, “There is no safety window.” That means that all statements that say it takes “at least” so many days or hours for a tick to transmit Lyme disease are false.
The CDC website says Lyme is largely underreported, especially in endemic areas. It should not say, “especially in endemic areas,” but rather “especially in states where many doctors don’t know the disease exists and don’t diagnose it.” It is vastly underdiagnosed in most states.
In 1990, Missouri ranked eighth in the nation in reported cases of Lyme disease. Then the CDC decided to call the disease STARI, because of genetic differences in the bacterium, and because it was being transmitted by lone star ticks. All the signs and symptoms in Missouri are exactly the same as Lyme disease. There is not a single symptom of Lyme disease that people in Missouri are not getting after lone star tick bites, except the ACA skin condition found in Europe. A study by Dr. Ed Masters found that patients in Missouri are twice as likely to develop arthritis as Lyme patients in the rest of the country. This is not a mild illness. There are many strains of flu, but they are all called flu. If different bacteria cause Lyme symptoms, they should all be called Lyme so they can be treated.
Several studies have found Lyme disease Bb bacteria in lone star ticks. Calling the disease STARI is causing thousands of cases to be undiagnosed in the central and southern states. Children have missed years of school, and adults have missed years of work, because the CDC has misled doctors into thinking that the disease in this area is a mild illness that can be ignored. Lyme disease and STARI are both in MO. The fact that STARI is in Missouri does not prevent Lyme disease from also being in the state, just as one strain of flu does not prevent other strains of flu from being in the same state at the same time.
The CDC’s link on their website to the IDSA treatment guidelines encourages doctors to underdiagnose and undertreat the disease. This needs to change. Overtreating the disease at the beginning can cure it. Undertreating it at the beginning causes people to need years of treatment later. It’s not just the lengthy treatment later that leads to the development of drug resistant bacteria; undertreating a bacterial disease at the beginning also contributes to drug resistance.
Almost everyone in our support group has chronic Lyme disease and babesia. Babesia is quite common in the central states. An unpublished study by Kansas State University found Babesia duncani and Lyme disease Bb bacteria in lone star ticks and mice on two farms in Kansas. All six people that live on those two farms have been infected with both Lyme disease and babesia.
A statement on the CDC website about babesia says, “Babesia is mostly in the Northeast.” It should be revised to say, “Most reports of babesia microti are in the Northeast, but there are other strains of babesia in other parts of the country.” The vast majority of doctors in most states are unaware that babesia is in their state, and they are thus not diagnosing or reporting it.
The babesia reporting criteria says that if a patient has a positive IgM test for babesia, but the IgG is negative, the IgM must be a false positive. This statement should be removed from the criteria. It’s an opinion. There’s no evidence for this. Many patients with Lyme disease and babesia may never develop IgG antibodies, because these diseases lower the immune system and can prevent the antibodies from developing.
The CDC website says prophylactic treatment of Rocky Mountain spotted fever (RMSF) fails to prevent the disease. Actually, in the study on this subject, lab animals were given only a single dose of doxycycline. There is no proof that longer treatment wouldn’t work. People given 4 weeks of treatment for a tick bite to prevent Lyme disease are not getting RMSF or ehrlichiosis.
The purpose of the CDC is to help people, not to harm them. Please stop making us disabled. Please stop misleading doctors into thinking that there is no Lyme disease or babesia in their states. Please remove the link to the IDSA guidelines from your website. Please allow us to get diagnosed & treated adequately.
Kathy White, BA Ed., MS Social Work
Vice-president of the Lyme Association of Greater Kansas City
Dear TBDWG members,
This task has been monumental and I thank each one of you on the Working Group and all members of the subcommittees for the dedication to work together to acknowledge and identify the problems and the needs of those already impacted by Lyme and other tick-borne diseases, and the problems and needs of those not yet impacted. It has been both a privilege and a huge burden so many of us share to serve in this process. I am so appreciative for all of the sacrifices that so many made to contribute to this urgent and critically important task.
I did not have enough time or energy to adequately address all of the issues of concern on each of the subcommittees from both a patient and advocate perspective; therefore, I wish to submit comments, best illustrated through personal and professional experience now below.
I have suffered personally, I have cared for children that suffer and I have supported hundreds of others outside of my family that are suffering from the impacts of these diseases in Colorado and beyond. I have a young niece that resides in Colorado that was denied an evaluation of Lyme disease when she presented with a bull's eye rash after recreating outdoors in Colorado merely because the CDC map that the physician reviewed does not include the state of Colorado as a risk for the primary disease vector. I have a teenage nephew in New Hampshire that was diagnosed with Lyme this month even though during his initial presentation of meningitis two years ago was never evaluated for Lyme and has now progressed to late stage infection with "classic" symptoms that were overlooked by physicians even in an endemic state. The theme for many that get infected and suffer chronic illness is the same: lack of awareness by patients and physician, missed early diagnosis, delayed or denied access to adequate timely care based on physician or insurance denial, lack of finances and lack of navigation to adequate care. Lack of reliable testing and curative treatment for too many.
I did not know the risks of nor how to prevent a tick bite. I was never provided this education or awareness from my parents, my educators, my physicians, nor my career employer (United States Forest Service). They didn't know to teach me. The time for change is now and is long overdue. Every citizen and visitor of the US, regardless of the region that they live in or travel to, should be provided awareness and effective prevention education. There is a resistance to embrace this public health message that is especially prevalent in states that are considered low risk.
I did not know about Lyme and tick-borne diseases when my symptoms first developed. Neither did my primary care physician, nor the nearly 50 other medical specialists, ER doctors, or prestigious medical care centers I visited recognize the illness in its acute stage...or chronic stage of disease. Years later, once Lyme disease was even a thought to inquire with medical care providers, I was told it could NOT BE LYME DISEASE BECAUSE LYME DOES NOT OCCUR IN COLORADO. Even though I am originally from an endemic region, I vacationed in endemic regions, had experienced multiple tick bites within Colorado and in endemic regions, worked in a high risk occupation as a wildlife biologist and wildland firefighter for the US Forest Service, Lyme and other TBDs were never considered during early infection nor late infection.
I was repeatedly denied laboratory testing for Lyme and other TBDs from multiple medical care providers. I was refused evaluation again and again as I was told that chronic Lyme does not exist or that it cannot be treated so "why bother testing?". I became increasing debilitated as diagnosis was delayed and my children and husband were suffering with what were thought to be unrelated issues. As the years progressed, I repeatedly lay writhing in the ER with narcotics barely easing pain enough for me to breathe. The thought of living without the cease of unbearable pain, fatigue, nausea, and any semblance of my former life was my greatest fear for myself and my family.
Even once laboratory positive test results were acquired, I was refused treatment. It took almost 8 years to diagnose the diseases and months after to get access to adequate care which required travel across the country. The losses each of us in our family have endured have been life altering. My entire family has been in treatment. One child and myself ongoing just to maintain any quality of life. Career gone, education impacted, finances lost. The emotional burden more than most can imagine. We are still standing and intact as a family, but not without wounds and ongoing struggle.
Infection is devastating on all levels. It creates conflict between patients and medical care providers who don't understand or even necessarily believe in the chronic nature of the disease, it creates conflict in immediate and extended family relations as the lack of understanding and the fluctuating nature of symptoms baffles even the person experiencing the disease. It ends marriages, and lives. It limits or takes away completely independence, employment, access to education, community and friendships. It kills hope.
Living in a region that is considered non-endemic for Lyme and multiple other diseases puts the health and well-being of residents and visitors at even greater risk through lack of awareness, prevention education, early diagnosis, and access to care which has resulted in needless suffering for far too many people.
PREVENTION: Living in a region that is considered non-endemic for Lyme and multiple other diseases has resulted in lack of access to prevention education in these regions. People that are getting sick in these regions have not been provided adequate resources at the State nor Federal level to be aware of nor prevent disease. Outdoor professionals and laborers are at higher risk due to extended periods in the outdoors and exposure potential to ticks. Federal agencies at all levels: OSHA, Military ( Army, Navy, Airforce, Marines, National Guard), Border Patrol, FEMA, NPS, USFWS, USFS, BLM, and BIA. At the State level, Parks and Wildlife Departments, Forestry departments and Cooperative Extension Service. All of these agencies must be a priority for access to best management practices for employees as well as the public users of publicly owned and managed lands. Federal, State and County Health Departments can be influential in both prevention education for the public and medical education of physicians to increase awareness and early intervention and access to care of both acute infections and chronic disease.
VECTOR SURVEILLANCE: Regions that are considered non-endemic for Lyme & other TBDs do not have active, nor even passive surveillance of tick pathogens being conducted by these States in these regions to monitor presence or spread of disease vectors. The absence of this information allows States to make statements about what does not occur here merely upon lack of information. One small, local, passive surveillance citizen science effort conducted by COTBDAA in 2017 last year resulted in two black-legged ticks being collected from dogs in Chaffee County, Colorado, the heart of the Rocky Mountains. One of these ticks tested positive for Lyme. Though both of the dogs that ticks were collected from had recent travel history, it highlights just how easily ticks are transported across the country, and the need for better surveillance of not only tick vectors, but the pathogens they are able to transmit. Companion Animal Parasite Council routinely demonstrates infection rates in dogs within this region that are not being recognized by the State as potential human health risks.
HUMAN SURVEILLANCE: Regions that are considered non-endemic for Lyme & low risk for other TBDs are also not recognizing nor reporting cases of human disease, simply because of the belief that these diseases do not occur in these regions. If a physician does not recognize nor believe in a disease, then laboratory tests are not ordered. Even if laboratory tests are ordered, they may be ordered to soon or sent to a lab with less ability to detect based on sensitivity or specificity. Diagnosed cases of Lyme disease are not being accurately reported to the CDC by many states that have individualized requirements for confirmed cases. The true burden of illness is not being assessed with current surveillance practices. Development of definitive tests to be used for BOTH acute and chronic disease must be a priority in both diagnostics and surveillance of diseases. But until that time, data collaboration (insurance codes, companion animal and wildlife data) to best assess the true burden of illness and risk must be utilized.
PATIENT ACCESS TO CARE: People living in regions that are considered non-endemic for Lyme & Other TBD's are at greater risk for delayed diagnosis and treatment due to lack of recognition of disease and early access to care, which increases risk for long term or chronic health impacts. Early diagnosis and treatment of diseases that can be fatal or chronically disabling are too often denied to patients in regions that are considered non-endemic for Lyme and other TBDs based on the belief that the disease does not exist here, misuse of existing surveillance data and/or of lack of surveillance data or awareness of disease manifestations. Patients are denied because physician awareness and education of Lyme & other TBDs is lacking (Medical students, ER, PCP and prestigious medical care centers, research and teaching hospitals), leaving patients to navigate their illness with inadequate guidance and often times irreparable harm because their physicians are not trained nor in some cases willing to help.
As a patient and patient advocate I have lived this experience as well as heard from so many others the barriers to care that they have experienced here in the Rocky Mountain Region and beyond. People that have developed chronic disease have been told that Lyme does occur in their state, have been denied access to evaluation for Lyme & other TBD's because the CDC surveillance maps do not extend into their states, or are told they have a "virus" with no further evaluation. Patients in non-endemic states have been told that their bull's eye rashes are spider bites, allergic reactions or dermatitis. They have been given short course antibiotics that have not adequately eradicated disease and did not recognize late stage infection or were denied further treatment. Patients have been denied laboratory testing or had positive results from labs negated as "false positives" , and worse, have been denied treatment because they did not meet CDC two-tier surveillance testing criteria. This outdated but widely accepted practice to diagnose on positive CDC criteria two-tier lab results alone has and continues to cause great harm to patients. This widespread practice has to stop.
COST: Delayed diagnosis and access to acute care increases the risk for chronic and disabling disease. Many people that are infected in the Rocky Mountain Region live in rural areas in large states and must travel great distances for any specialized care, let alone care by a physician experienced in Lyme and other TBDs. Lyme Literate Medical Doctors (LLMDs) are most often booked out months or even years, and most do not work with insurance companies. These impacts have been devastating for individuals and families. Loss of health, employment, savings, homes, education. These people are often forced to navigate the illness alone....completely alone, most without the financial resources necessary. No team of doctors to support their care, no way to fund or find access to evaluation or treatment. No ability to travel to the currently available LLMDs, no access to SS disability support, no support for children trying to access their education with the physical, emotional and psychological challenges that are faced by our children...OUR CHILDREN!! Many people were fully functioning contributors to society, living quality lives on every front before being infected. Many have never had the chance to be functional members society or live a quality life...being infected early in life, without access to restorative treatments or education to support health nor employment. This is costing individuals, families, employers and our society in ways that have not yet been evaluated.
Everyone should be afforded access to effective prevention education regardless of the region in which they live work or travel. Everyone should have access to early and adequate evaluation, tests, diagnosis and treatment that restores them to a place of wellness regardless of where they live, work or travel. All future efforts at the national level should strive to serve all regions of the country and to stop the spread of ticks and of these diseases that are devastating and taking lives at an alarming rate.
Colorado Tick-Borne Disease Awareness Association
I have had Ehrlichiosis and Lyme's Disease, and now I have Alpha-Gal. All tick born diseases can cause serious consequences to a person's body and life style, but I am asking that you not ignore all of us who live daily lives reading food, medication, personal hygiene, and a myriad other labels; just so we don’t react to some hidden mammal product in what we use on our bodies or consume. The public desperately needs to be made aware of the ramifications of living with Alpha-Gal, along with education on how to protect themselves from contracting this mammal meat / and by products allergy.
It should be a mandate that all doctors and hospitals be made aware of what Alpha-Gal is and how to safely treat their patients so that no other harm may be done to a patient due to lack of education and bias.
Thank you for considering my comments.
This is an addendum to my life threatening story of Alpha Gal.
Early in the spring of 2018 I had been bitten by a tick on the base of the lower part of my spine; causing pain & extreme fatigue.
Three weeks later I had to be Life-flighted to a hospital in Little Rock, Arkansas. I was admitted to ICU, non-cognitive of anything. They were administering meds for viral/bacterial infections they believed to be causing the Encephalitis. The family had brought the tick bite up on several occasions, without avail. It was the following evening before I was able to be cognitive of reality, again. I was released within 48 hrs back to my primary Physician. I have obtained my records and it was amazing how it was treated. Even to the point they wanted to administer Psychological tested and not consider a tick borne reaction.
I was prescribed Doxycycline by my primary for 30 days; along with increase of regular supplements to boost my immune. Alpha Gal had still not been diagnosed.
Had another reaction that ended in the ER with throat and tongue swelling. They administered a long acting steroid & I began to be able to feel air back to my windpipe. Scary!
My primary tested for Alpha Gal on April 4th; test returned positive for Alpha Gal June 11th with a Titer of 11.90. I was told to eat no mammal meat, or supplements with meat by products. Nothing else.
I was still, having extreme exhaustion. I joined a couple of groups online, as I was researching all of this new information. I was amazing to find out how much meat by products is in our foods, supplements, & health care products. I stopped my supplements & my energy improved; stopped my hand cleaning products, even got better; shampoo, toothpaste, soap, less fatigue. I was in shock! All along these products were causing this Alpha Gal to play havoc in my body.
I have just learned the hormone therapy I have been prescribed has mammal products in them. Which is now going to be a major problem. This will be another learning experience.
I have learned the hard way, the organic fertilizers we had put in the garden, in January 2018 was a huge trigger. Every time I am in the garden and do any work around the ground with goat, horse or cow manure, I become extremely out of it, can't keep my eyes opened and lethargic. I have taken my allergy meds to keep the reaction from becoming worse. My husband has to take the time to watch over me to assure to it doesn't get any worse. I go straight to the house and fall on the couch for at least an hour or two. It has affected every part of our life. If I worked for another company they would have already fired me. My husband and I are having to make the decision, if we can keep farming. This has been our life and now can change my life.
I truly would be willing to do anything to feel better. This allergic reaction to these things could have and can change my life, or disable me. I am a Certified Natural Farmer and believe in the all natural way. I worked hard to have a good healthy life, even as a 57 year old great grandmother. Life is Good! I don’t want it to end early.
Please let’s do all we can to get the word out there and educate to prevent tick borne disease. Our doctors, hospitals, employers, and restaurants' need to know in order to help us, not hurt us.
I have been living with the alpha-gal food allergy since the summer of 2015. In May of 2015, I had an episode of uncontrollable hives over my entire body that was linked to multiple lone-star tick bites received six weeks prior and ingesting food containing meat or dairy. Luckily, my general practitioner was knowledgeable about alpha-gal through experience with other patients with the condition, and promptly ordered an alpha-gal allergy blood test. After confirmation that I had alpha-gal, I was referred to the UNC allergy clinic. Treatment was 14-weeks on a high dose prednisone taper and large doses of anti-histamines. In my case, I was lucky. The hives eventually subsided and diagnosis was swift compared to other people suffering for years without relief because of lack of knowledge about this tick-borne disease in the medical community.
My life has been permanently impacted in a profound way since being diagnosed with alpha-gal. While most people with alpha-gal are advised to avoid mammalian meat, I must also avoid dairy. Exposure to even small amounts of dairy, can cause my skin to break out in hives, feel sun-burned, and itchy and crawly-feeling. In addition to physical discomfort caused by alpha-gal, the side-effects of being on anti-histamines impacts my ability to mentally focus and causes tiredness and lethargy. As a result, I miss work, social engagements, and time with my family. My mental well-being suffers as I am isolated and physically uncomfortable.
The unpredictable nature of the exposure and response of the alpha-gal allergy creates high anxiety. The ingredients of every package of food must be carefully scrutinized before consumption. The casual act of eating out in a restaurant is difficult and emotionally taxing. After dining at a restaurant or a friend’s house, there’s always lingering questions of what if I accidentally ingested meat or dairy and what may happen to my body if I was exposed? Will I need to use an Epi-pen? While certainly inconvenient and irritating, there is no doubt that the anxiety created by fear of exposure impacts my mental well-being.
In the US, the habitat of the lone-star tick is expanding and the alpha-gal allergy is spreading. More and more people are becoming diagnosed with the allergy or have the allergy and are not properly diagnosed. As someone with direct experience with alpha-gal, some suggestions to help raise awareness and understanding of alpha-gal include the following:
- More medical research is needed to help understand the disease, long-term implications, synergies or amplification effects with other seasonal allergies, and more effective treatment options (i.e. vaccines).
- More scientific research is needed on ticks (chiggers and other potential species of insects causing alpha-gal) including understanding of the species life cycle, host species, and habitat.
- The medical community is not fully aware or educated about tick-borne diseases. More education and outreach are greatly needed so that patients can get diagnosed quickly and treated.
- Medication labels should be required to indicate if medicines contain animal products and more vegan medication alternatives need to be manufactured.
- Epi-pen expiration dates are one-year. Having this life-saving medicine available at all times is very expensive. The costs should be reduced to be affordable or subsidized.
- More public education and outreach is needed so that people can prevent exposure to tick-borne diseases.
Thank you for your time and interest.