All Tick-Borne Disease Working Group (TBDWG) meetings dedicate time for public comments. The Working Group invited public comment on issues related to the Working Group's charge. Verbal comments were provided over the phone during the meeting. Written comments were submitted via email to the TBDWG inbox. Below are the written comments submitted by individuals for the May 10, 2018, meeting.
Topic: PREVENTION ITEMS –What I consider easiest plus those with highest payoff potential. Our subcommittee did not rank them as such.
The reason I volunteered to participate on the Disease Vectors, Surveillance and Prevention subcommittee was because of my commitment to prevention of Lyme and TBD, especially for our children. In the past 40 years, ticks and their pathogens have spread and increased like wildfire. Tick researchers hold the greatest chance to bring about fruitful solutions, but funding for this field of science has been a pittance. Scientists retire with no graduating scientists to replace them thus knowledge and the ability to train is lost. Until this research is funded this scourge of ticks and their pathogens will continue their march across the US and elsewhere in the world.
The following is crucial:
- Reduction of the tick population.
- Blocking the ability of ticks to transmit multitude of TBD pathogens.
- Public education to understand how best to protect themselves and their landscape.
The dire need to support tick research, which holds the best chance to achieve fruitful solutions to the above first two items. Without that, ticks and TBD, will continue to increase in numbers and their geographic range. Likewise, as we’ve just recently seen in New Jersey, with the invasion of the Asian H.longicornis, other ticks and diseases, some hemorrhagic and encephalopathic will certainly reach our shores. Will we be ready?
On the issue of surveillance, I have been concerned about the CDC/CSTE refusal to accept NYS statistically derived reporting which is about 50% of the case numbers reported by NYS. Thus, I wished to assist with implementing a change to include these numbers! I discovered this was a much more complicated issue. Additionally, the federal case numbers are important when appropriations are being decided for our governmental agencies. Right now, when Congressional staffers and Congress members look at the CDC report for Lyme disease, they only see 36,429 cases, when the actuals are estimated to be over 300,000. That is not very impressive when it they are deciding the allocation of funding for TBDs. Furthermore, the surveillance case definition is used like the Bible by healthcare workers causing so many unnecessary horrid results.
On another issue, the Subcommittees were asked to rate the methods using the PICK chart. On our subcommittee, we did not use this in regard to the potential of prevention measures. Therefore, I am taking the liberty to do so. There are those with the very highest payoff, these may require more funding and a longer research time: tick microbiome studies, transgenic ticks, RNAi, anti-tick vaccine for humans and prime disease vectors, etc. Another set, are those with the potential to be highly effective, speedier to implement, and at relatively lower cost: PCO education, safe Nootkatone for personal protection, semiochemicals to “arrest and kill” ticks, and highway signs. These and others are discussed in greater detail in Priorities 2, 4 & 5. They are what I consider some of the most promising but they were not voted on by the subcommittee in regard to the “PICK.”
Just two examples follow below.
Professional Pest Control Operator Education, which could be easily, quickly, inexpensively implemented to potentially deliver an effective result:
Develop best practice tick control training materials (on-line training, videos) for PCOs, and make continuing education (CE) compliance a requirement for continuing PCO licensure.
Explanation Details in Priority 2 and Priority 5:
As evidenced by the CDC study of acaricide spraying of 2,727 households by professional pest control operators (PCOs) resulted in an average of 63% reduction of nymphal blacklegged ticks (Hinckley et al., 2016). When comparing that to the 95-99% reduction of nymphal blacklegged ticks that researchers achieve, it was evident that something was different. Just one difference was that researchers always use a high pressure spray to obtain a high kill rate, whereas less powerful backpack sprays were used by the PCO. PCO’s want to do an effective job, but they just did not have the knowledge to do so. In a survey of Connecticut wells, 70% of homeowners use some kind of insecticide/acaricide (Addiss, Alderman, Brown, & Wargo, 1999) demonstrating how many residents may be affected. These homeowners may be left with about 40% of ticks crawling around in their yards rather than less than 5%. This leaves them at high risk especially because they expected that they were protected. PCO’s are considered first-line responders to the tick infestation with a professional and moral obligation to comply with best practice standards, including application of validated effective products and methods of application. The opportunity for tick prevention education within this group could be tied to state PCO licensure and renewal. In the absence of standardized best practices for tick management across all regions, PCOs are left without guidance regarding science-based recommendations for products, methods, and practices, all of which may impede development of effective continuing education materials.
Nootkatone, patented by the CDC, could potentially relatively quickly be available, inexpensive for the public, quick, effective and is already under development for mosquito control.
Bring Nootkatone products to market for tick prevention just as it is being done for mosquitoes
Explanation some Details are in Priority 2.
Safe Nootkatone holds great potential as a fantastic preventive product because it kills ticks and mosquitoes. Used in food and fragrances, it’s safe for humans also bees. A test was done that demonstrated that with soap containing nootkatone washed ticks off of mice. Therefore, as a personal care product, such as a soap, it could be very successful in preventing Lyme and many other TBD pathogens with a simple evening shower or bath. It could reduce Lyme and most other TBDs that take more than 12 hours to transmit from the tick into humans. Patented by the CDC, Evolva holds the license to it and was awarded $8.35 million by the CDC to register it with the EPA and develop mosquito products (Zika funding). Now it’s time for ticks!
See the following very short videos.
Potential for nootkatone vs Lyme and TBDs and Mosquitoes: https://www.youtube.com/watch?v=wDtZioPrquo
Nootkatone treated vs untreated finger: https://www.youtube.com/watch?v=imG0kIX-eLc
Good explanation about safety (used in food and fragrances): https://www.evolva.com/nootkatone-flavor/
- It could be successful because:
- No new habits need to be formed, people use soap and shampoo.
- It is simple to use. It would be relatively inexpensive.
- It would be safe.
- It might be better adhered to than tick checks and you don't have to see them
- It would alleviate parents having to perform invasive tick checks of children's personal areas.
- With CDC backing, as with DEET etc., it could be widely accepted and used regularly by the public therefore, reduce TBDs far better than what is available. Then the states and local governments would also promote it.
Just a comment, when the CDC speaks out as with their recent report regarding “Illnesses from mosquito, tick, and flea bites have tripled in the U.S.”, the major news sources carry it and the public hears. That is a very effective manner to educate the public.
Thank you for providing me with this opportunity to comment,
Tick Research to Eliminate Diseases: Scientist Coalition, Coordinator
Public Integrated Pest Management Work Group, Member
Stop Ticks On People (S.T.O.P.), Board Member
NYS Senator Serino's Advisory Board on Lyme and TBD, Co-chair
Hudson Valley Lyme Disease Association, Chairperson
Dutchess County Legislative Tick Task Force, Member
Federal Coalition on Lyme and Tick-borne Disease, Member
NYS Coalition on Lyme and Tick-borne Disease, Member
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 and commends the group for tackling this important issue. 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 to have all patients achieve the best possible outcomes.
IDSA has worked over the years to educate policymakers, healthcare providers and the public about Lyme disease and other tick-borne diseases to advance prevention strategies, improve diagnosis, prevent unnecessary and potentially harmful antibiotic use, and ensure all patients receive the best available care.
IDSA strongly supports increased funding for the National Institutes of Health to enable enhanced Lyme disease-related research and for the Centers for Disease Control and Prevention to improve public health approaches to the epidemiology and prevention of Lyme disease and other tick-borne illnesses that help guide clinicians and keep people healthy.
We believe there is a great opportunity in this Working Group and its Subcommittees to address outstanding issues and gaps in knowledge around Lyme disease. We look forward to the results of these efforts. For each subcommittee, we outline the areas that we believe would most benefit from further attention and research. We offer recommendations to help advance each of these areas.
Testing and 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 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. Currently, 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. IDSA encourages the working group to recommend greater federal support to advance research and development of new diagnostics.
Disease Vectors, Surveillance, and Prevention:
IDSA also acknowledges there are gaps in our understanding of the epidemiology and prevention of tick-borne diseases. In areas of the country where Lyme disease is endemic, the disease epidemiology is better understood and, in some locales, well-defined and, hence, may not need expanded surveillance for the disease. However, Lyme and other emerging tick-borne diseases have begun to spread past historically endemic areas to threaten new populations. IDSA supports enhanced surveillance to monitor the spread of Lyme, as well as other diseases such as anaplasmosis, babesiosis, ehrlichioses, tularemia, rickettsial infections, and Powassan virus. Good surveillance is needed to help researchers and epidemiologists understand the increasing prevalence of these diseases over the last 15-20 years. Clinicians can only make informed decisions in these emerging and border regions with timely and accurate data about whether certain tick-borne infections exist in their community. Surveillance of both tick and human populations is critical.
CDC studies have yet to demonstrate that interventions such as acaricidal sprays that noticeably reduce tick populations reduce the incidence of tick-borne diseases.12 ,Personal tick prevention strategies such as DEET and wearing long clothing have not staunched the vector-borne diseases as well-outlined in the recent CDC study finding a tripling of such infection.3 New measures are needed, and they will require careful study and evaluation to confirm effectiveness. IDSA encourages the working group to recommend increased funding for CDC to strengthen prevention and surveillance of tick-borne diseases.
Vaccines and Therapeutics:
Vaccination has been shown to be an effective way to prevent Lyme disease. Several new vaccine candidates are currently under consideration, but progress has been slow. Manufacturers are concerned that there may not be sufficient uptake of a Lyme vaccine to provide an adequate return on investment. IDSA encourages the working group to review the pipeline for these vaccines and make recommendations to spur development and uptake. The potentially vulnerable populations in the U.S. alone should be more than sufficient; however, enthusiasm has been dampened by prior experiences prompting the manufacturer of Lymrix to withdraw their vaccine in 2001.4 Safe immunization against a vector-borne disease such as B. burgdorferi is the most cost-effective method to keep people healthy and free of disease.
Pathogenesis, Transmission, and Treatment:
There is no robust scientific evidence supporting the use of long-term antibiotic therapy in patients with Lyme disease that gains them sustained benefit. In fact, there is evidence that long-term antibiotic therapy for patients can lead to serious and life-threatening complications and can accelerate the development of antibiotic-resistant bacterial infections in patients. Patients who have been on long-term antibiotic therapy after diagnoses of chronic Lyme disease have later developed Clostridium difficile, Pseudomonas aeruginosa, Acinetobacter, and other infections. Some of these patients developed septic shock and died.5 IDSA supports increased research to understand why some patients develop persistent symptoms after treatment for Lyme disease. Improved understanding of mechanisms should help lead to the development of safe and effective therapies to reduce or eliminate the symptoms of this condition. We urge the Working Group to support evidence-based care for Lyme disease and other tick-borne illnesses and to recommend additional research to understand better and safely and effectively treat symptoms that long linger following Lyme disease treatment.
Other Tick-Borne Diseases and Co-Infections:
There are many other serious and potentially fatal tick-borne diseases such as Powassan virus, babesiosis, anaplasmosis, ehrlichiosis, tularemia, Rocky Mountain Spotted Fever and other spotted fever group rickettsioses, anaplasmosis, and others. These diverse infections may present with symptoms and signs somewhat similar to early Lyme disease including fever, aches, and rashes. Some of these diseases are also expanding into new geographic areas. Thus, increased surveillance and epidemiology, as well as additional research into these diseases would be greatly beneficial. We encourage the Working Group to ensure that its recommendations appropriately cover the breadth of tick-borne diseases.
Access to Care Services and Support to Patients:
To ensure optimal patient outcomes, IDSA supports access to evidence-based care and policies to protect patients from treatments that lack rigorous scientific evidence regarding efficacy and any potential toxicity. We encourage the Working Group to focus its efforts on recommendations to expand access to evidence-based care that is safe, effective, and in the best interests of patients.
We look forward to the Working Group and Subcommittees’ findings and areas of consensus regarding the need for better diagnostics, expanded epidemiology, and enhanced prevention approaches to control Lyme and other tick-borne diseases. IDSA stands ready to lend expertise that the Working Group may find helpful.
Paul G. Auwaerter, MD, MBA, FIDSA
- AF Hinckley et. al. Effectiveness of Residential Acaricides to Prevent Lyme and Other Tick-borne Diseases in Humans. Journal of Infectious Diseases. Vol. 214, Issue 2, Pages 182-188. July 15, 2016.
- L Eisen, R Eisen. Critical Evaluation of the Linkage Between Tick-Based Risk Measures and the Occurrence of Lyme Disease Cases. Journal of Bacterial Entomology. Vol. 53, Issue 5, Pages 1050-1062. September 1 2016.
- Centers for Disease Control and Prevention. Vital Signs: Trends in Reported Vectorborne Disease Cases- United States and Territories, 2004-2016. MMWR Weekly. May 1, 2018.
- LE Nigrovic, KM Thompson. The Lyme vaccine: a cautionary tale. Epidemiol Infect. Jan 2007; 135(1): 1-8.
- Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report. Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease. Weekly. June 16, 2017.
May 6, 2018
Dear Tick Borne Disease Working Group Members,
Please accept my submission listing selected quotes and citations for scientific literature documenting the history of the occurrence of congenital transmission of Borrelia burgdorferi (Lyme disease) and other tick and vector borne diseases in humans and other mammals.
Science regarding the congenital transmission of Lyme disease dates back as early as July 1985 and continues through February 2018. Congenital Babesiosis literature includes select publications dated 1975- 2016. Bartonellosis, Anaplasmosis and Tularemia congenital transmission is documented from 1945 and includes a publication dated as recently as 2016.
In the June 1985 MMWR Weekly from the Centers for Disease Control and Prevention (CDC), it states: “Transplacental transmission of B. burgdorferi has been documented in a pregnant woman with Lyme disease...” The article continues- “Of the 19 pregnancies evaluated to date, none resulted in a child with a congenital heart defect. However, other adverse outcomes were found, including intrauterine fetal demise in the second trimester, prematurity, and developmental delay with cortical blindness.”
Since that time numerous scientists have documented the presence of spirochetes and other tick borne organisms in fetal tissues, blood and organs. Combined, the literature on various tick borne diseases portrays a solid foundation for Borrelia, Babesia, Bartonella, Anaplasmosis and Tularemia to be congenitally transmitted. This serious situation has been almost totally buried and/or ignored. Very few, if any, notices have been sent by the CDC or our health departments to medical professionals regarding the potential for congenital transmission of Lyme or any other tick borne diseases, even in endemic areas.
Parents and physicians learning about the congenital transmission of Lyme by way of an infant autopsy- well, there must be a better way to educate people that I hope you will explore.
The public and medical professionals should be informed that congenital transmission is a very real possibility and all efforts to prevent transmission from occurring should be considered and discussed by the Working Group. Please review the attached literature and make education and notifications regarding congenital transmission a high priority on the list of “things to do”, as should certainly have originally been done several decades ago.
Thank you very much for your time and consideration. I appreciate your work and efforts.
Congenital Transmission of Lyme & Tick Borne Diseases: https://sites.google.com/site/marylandlyme/congenital-lyme
Selected Abstracts- Pregnancy & Congenital Lyme Disease: https://sites.google.com/site/marylandlyme/pregnancy-lyme/congenital-transmission-of-lyme-tbd-citations
How to Check Babies for Congenital Lyme Disease- Ask The Experts: https://sites.google.com/site/marylandlyme/ask-the-experts/testing-infants-for-congenital-transmission-of-lyme
Deaths- Infants & Children: https://sites.google.com/site/marylandlyme/pregnancy-lyme/deaths--infants-children
Dr. John Drulle- Pregnancy & Lyme: https://sites.google.com/site/marylandlyme/pregnancy-lyme/pregnancy-outcomes
More Reports of Deaths- Infants and Children: https://sites.google.com/site/marylandlyme/memorial-page/infants-and-children
Art Doherty Collection- Pregnancy Complications & Lyme: https://sites.google.com/site/marylandlyme/pregnancy-lyme/art-doherty-s-links-pregnancy
Congenital Lyme Reference- Another Good Reason To Keep Your Pants On: https://sites.google.com/site/marylandlyme/sexual-transmission
Pregnancy Citations/Abstracts 1985-2013: https://sites.google.com/site/marylandlyme/pregnancy-lyme/pregnancy-citations-abstracts
The 700 Citations for Persistent Lyme Disease- Includes A Section On Congenital Lyme: https://sites.google.com/site/marylandlyme/chronic-lyme-disease/700-citations--persistent-lyme-disease
Syphilis & Borreliosis During Pregnancy: https://sites.google.com/site/marylandlyme/pregnancy-lyme/syphilis-lyme-pregnancy
Other Modes of Transmission- Dr. Kroun Collection: https://sites.google.com/site/marylandlyme/sexual-transmission/other-modes-of-transmission---dr-kroun
Research On Umbilical Cords: "Williams and colleagues conducted a study in a Lyme-endemic area in New York of umbilical cord blood. Of 255 infants tested, 10.2% had detectable antibody to the Lyme spirochete. Of 166 infants born in a non-endemic area, 2.4% had detectable antibodies. Paediatr Perinat Epidemiol. 1995 Jul;9(3):320-30. Maternal Lyme disease and congenital malformations: a cord blood serosurvey in endemic and control areas. Williams CL1, Strobino B, Weinstein A, Spierling P, Medici F. 1Child Health Center, American Health Foundation, Valhalla, New York 10595,USA. http://www.ncbi.nlm.nih.gov/pubmed/?term=williams+cord+blood+spirochete: https://sites.google.com/site/marylandlyme/sexual-transmission/bibliography
Dr. Harvey/Salvato: "The CDC defines “Lyme disease” exclusively as a zoonotic illness. Congenital and gestational transfer cases have been disregarded for reasons not evident to us."; https://sites.google.com/site/marylandlyme/sexual-transmission/unrecognized-borreliosis-pandemic-harvey-salvato
Dr. Sam Donta- Late & Chronic Lyme Disease: "Rarely as well are congenital and intrautero infection; when this occurs, it appears to be similar to toxoplasmosis and rubella, i.e. a primary infection during the first trimester." https://sites.google.com/site/marylandlyme/lyme/fibromyalgia
Pregnancy- Lyme & TBD: https://sites.google.com/site/marylandlyme/pregnancy-lyme
The Late Dr. John Bleiweiss: "Flawed studies have created the impression that pregnancy outcomes are not influenced by LD. There is substantial documentation to suggest a causal relationship between LD and stillbirths, congenital abnormalities, spontaneous abortion, low birth weight babies, prematurity and intrauterine fetal infection acquired from the mother. An outcome of untreated LD arising from Mg++ deficiency could be pre-eclampsia (hypertension) or eclampsia (hypertension with seizures). Magnesium is often relied on to treat these problems. Women with LD in pregnancy can experience severe morning sickness, gestational diabetes mellitus and prominent flares of Lyme related symptoms. As both LD and Sudden Infant Death Syndrome are attended by sleep apnea, this should impel further research to determine if some babies with SIDS are actually suffering from LD. Bb can appear in the breast milk." https://sites.google.com/site/marylandlyme/patient-stories/dr-john-d-bleiweiss--when-to-suspect-lyme
Sue Faber, RN BScN- Congenital Lyme Disease Documentation: http://www.lymehope.ca/uploads/8/4/2/8/84284900/32_years_of_literature_review_march_25_2018.pdf
Congenital Transmission of Babesiosis
2018 "...2 infants with congenital babesiosis born to mothers with prepartum Lyme disease..."; https://www.ncbi.nlm.nih.gov/pubmed/28992325
2015 "Four ... of five infants with congenital babesiosis whose neutrophil count was reported were neutropenic."; https://www.ncbi.nlm.nih.gov/pubmed/26071466
2010 "Congenital babesiosis in a four-week-old female infant"; https://www.ncbi.nlm.nih.gov/pubmed/20118748
2009 "... third congenital case of babesiosis in a 26-day-old infant; transmission was determined on the basis of a blood smear from the infant (15% parasitemia) and serologic results from the infant and mother." https://www.ncbi.nlm.nih.gov/pubmed/19402971
2006 "Neonatal babesiosis: case report and review of the literature"; https://www.ncbi.nlm.nih.gov/pubmed/16462298
Babesiosis Transmission in Mammals
2017- Prevalence, genetic identity and vertical transmission of Babesia microti in three naturally infected species of vole, Microtus spp. (Cricetidae); https://www.ncbi.nlm.nih.gov/pubmed/28166832
2015- Vertical Transmission of Babesia microti in BALB/c Mice: Preliminary Report; https://www.ncbi.nlm.nih.gov/pubmed/26372043
2005- "This is the first confirmed report of transplacental Babesia infection in any animal species." https://www.ncbi.nlm.nih.gov/pubmed/15979628
1976- "A case of intra-uterine transmission of Babesia bovis is reported. The calf was born normally but showed signs of intravascular haemolysis and nervous involvement 24 h after birth."; https://www.ncbi.nlm.nih.gov/pubmed/1018892
1975- Letter: Prenatal Babesia bigemina infection in a calf; https://www.ncbi.nlm.nih.gov/pubmed/1220660
Congenital Transmission of Bartonella
2016- "A putative vertical Bartonella henselae infection was defined on the basis of ultrastructural and molecular analyses in a three-year-old child with anemia, jaundice and hepatosplenomegaly since birth."; https://www.ncbi.nlm.nih.gov/pubmed/27410916
Congenital Transmission of Anaplasmosis
1987- 2017 Documented in Animals Only; https://www.ncbi.nlm.nih.gov/pubmed/?term=Anaplasma+congenital
Congenital Transmission of Tularemia
1947- Congenital Tularemia; https://www.ncbi.nlm.nih.gov/pubmed/20288663
My name is Maureen Foley-Bolling and I would like to share with you my TBD story.
I had a tick attached on me in 1996 in North Waterboro,ME. My spouse at the time burnt the head off versus pulling it out with tweezers. A slight rash was around the abdominal area where it attached however no bull's eye. I was not lyme literate at the time so without the bull's eye I thought all was fine. Between that time period and 2006 when my neuro symptoms erupted I experienced many bouts of flu-like symptoms along with various joint pains. I thought it was due to working in the hospital setting as a respiratory therapist. I was always exposed to different infections and assisting with lifting patients.
In 2006 I was working as a sleep technologist and suddenly out of the blue my face started twitching and I became aphasic...I could not speak and I had to have the other therapist explain directions to the patient I was monitoring. I stopped at my physician's office after I got off duty and they noticed my blood pressure was elevated. My face was drooping on one side at this point and still had difficulty with speech. They rushed me to the hospital as they felt a possible stroke was occurring. For the next 10 months I was worked up with a multitude of tests. Meanwhile, my anxiety increased and I started to have more neurological symptoms such as gibberish speech, unable to walk, seizure like episodes, and ticks and muscle twitches and spasms. An ELISA was performed at one point but this test was negative. I now know this test has a low accuracy rate when already in the advanced stages of lyme disease. They diagnosed me with conversion disorder. I received cognitive therapy however flu like symptoms continued as well as the tics and manifestations. I kept asking the provider(s) why I kept having these ongoing symptoms irregardless of receiving this therapy however nobody could answer.
I received antibiotics a number of times for sinus infections and when I did my symptoms improved some. I did not really question why at this point, but now I realize the antibiotics not only helped my frequent sinus infections but must have been helping with my lyme symptoms. I tried to return to work multiple times only to relapse. I did receive disability but only because I did try to return to work and my symptoms were not relieved.
In 2013 I did work for an acupuncturist for almost a year. During this time frame she gave me herbal supplements to help with my GI issues and other inflammatory areas in my body. My GI symptoms were worsening and then I started to get more neuro issues again . This time, blurry vision and electric shocks to my extremities . The acupuncturist told me to get a western blot through Igenex in California. I did and three weeks later my results came back positive. Looking back through my old records in 2011 my PCP did order a western blot but through another lab known as Imugen. My WB came back negative by CDC standards. I did have two positive bands which I now know are highly positive for lyme.
Since 2013 I have seen many clinicians for my ongoing issues. I have spent out of pocket at least $10,000 per year.
My spouse has also been diagnosed with TBD's of lyme and erlichiosis. I also have a TBD that tested positive finally for bartonella within the last month. This infection is very difficult to isolate with the blood testing we have now.
Within the past month I have had to be sent by ambulance to different area hospitals for worsening symptoms of seizures. They were lasting for more than an hour. Two occurrences occurred in my PCP's office as well as my lyme clinician's office. I have been through both herbal and western med antibiotics and combinations of both. Each time I am brought to the hospital the clinicians look back at my old records before I was diagnosed with lyme disease and still state my episodes are psychogenic versus inflammation related from my lyme and bartonella. I was restarted recently on antibiotics and my lyme clinician started me on neurontin (an anti-seizure) medication. I have improved greatly just with these three medications!
I now however have " to prove " my seizures are lyme and bartonella related vs psychogenic. My EEG did not show any abnormal electrical activity however my seizures were induced with this study by the photic stimulation during the study. Many times the seizure activity may not show up on the EEG's I have been told. I feel they are partial as I cannot respond during the episodes yet I am aware they are occurring. I need to wear sunglasses or special glasses to block blue lights from the tv/computers.
My spouse now has to be treated as well. He has ongoing joint pains and headaches as well as brain fog from time to time. He is on antibiotics for a month however his clinician prefers herbals. He was diagnosed in 2013 as well but only does treatments when his symptoms start to worsen again.
I am praying that this committee can come up with solid plans for diagnosing and treating. We need the CDC and IDSA to work together with the ILADS and LDA to come up with long- term solutions for diagnosing and treating. I am hoping naturopaths and their modalities of treating will be covered by insurance. Other natural approaches besides allopathic medications need to be covered. The herbals distributed by lyme clinicians have been helping many lyme sufferers. Acupuncture and massage therapy also helps . Stem cell therapy has been shown to help as well.
This illness has robbed us emotionally, physically, and financially. We are now in debt due to this illness. We have to pay cash for most treatments as insurers will not cover the herbals and medicare did not reimburse the lyme clinician. She has now stopped accepting medicare. Another clinician that has agreed to see me because my symptoms were worse and felt I needed the more aggressive therapy is still awaiting medicare approval. She has helped me immensely though willing to see me pro bono a couple of times. I hope she receives medicare approval shortly as we cannot afford to pay the visits out of pocket. I am hoping this letter will make you realize not only myself but many others are going through the same issues.
Thank you for reading my letter.
Dear members and subcommittees of the TBDWG
Fixing access to care issues needs to begin with mandates for states to adopt a single federal standard on definitions related to surveillance to provide meaningful and consistent surveillance nationally. Adequate understanding of surveillance data can only occur when data is consistent across the country in the way in which it is collected.
Currently many states showing low levels may be seen as non-endemic due to the reporting issues and challenges, not due to true non endemic areas. I believe that we should consider allowing for other mechanisms of reporting to the CDC, such as through Non-Profit organizations working in affected states. These approved non-profits should be required to go through a TBDWG Approved training to provide excellence in reporting standards.
Because Oregon Lyme Disease Network (OLDN) has been studying, surveying, and advocating tick borne disease, and because we have been working with Oregon Health Authority and Public Health and legislators since 2001 on Lyme disease in Oregon, we have a clear understanding of what is going on in Oregon, and this may help many other states having similar issues.
Back in 1937 “The Ticks of Oregon” By W. J. CHAMBERLIN was published. The publication noted established ticks, tick pathogens and the financial impact to health, farming and forestry sectors. It is clear that ticks and infections they carry are well established in Oregon.
In 1997 (Burkott, Clover and Lane) and four counties were sampled for ticks, and ticks were only found in three of them. All three counties were positive for both the vector that carries Lyme Disease, and pathogens within the vector. In a study by Gilbert in 2003, Oregon also proved Lyme Disease vector and infection in Hood River county. This study also stated there was no risk near Portland Or, yet contradicted itself in its figure 1. http://jcm.asm.org/content/46/6/2115.full.
“None of the 47 ticks collected in the urban area were positive for B. burgdorferi. We postulate that Lyme disease cases reported in the greater Portland area were either acquired by exposure to endemic foci in southwestern Oregon, in popular recreational sites in the Columbia River Gorge, or in areas in the eastern United States where Lyme disease is endemic.”
Yet the maps in fig 1 states “Note the location of Portland, the Columbia River, and the three counties in southwestern Oregon that have the highest density of I. pacificus ticks.”
Finally the study shows a map with the east side showing no established ticks, while the 1935 study clearly shows established ticks in the east, and the current studies did not test East of the mountains except for Deschutes Co where infected ticks were found. OLDN has challenged the results of this study due to a lack of financial trail to support full state travel for sampling, conflicts of interest of the principal and conflicts within the paper. To date the information requested has not been available to prove this study was properly executed. Nor have inconsistencies been remedied.
Our current public health statement says “The risk of clinical disease correlates with the percentage of infected ticks. Oregon has a relatively low percent of infected ticks.” What the state fails to state is studies were limited to 4 of 36 Oregon counties and that 75% of the counties sampled showed infected ticks. This deliberate minimizing of the issue to the public, to the CDC and to the medical professionals diminishes the patient’s access to care and CDC reporting.
In Sept 2016 Oregon Lyme Disease Network began to engage the CDC with the help of Congressman Greg Walden’s office. His staff, Kristen Shatynski worked with the CDC and they offered to support a tick study, in fact it was a good time because they had people in WA doing surveillance work as well. They agreed to provide financial and laboratory support for testing, provide entomologists to confirm tick species and genders and other support as needed. However, the CDC is mandated to work with Public Health, and our public health said NO –citing a lack of resources. Despite that our organizations ability to provide resources through our networks, which included tick collection by private citizens, BLM, NFS and other outdoor groups , and logistical resources to document GPS locations for GIS mapping, and provide other support for the study, we were still denied by the State Public Health so CDC could not engage even though they wanted to.
At the same time tick surveillance has been limited, human infection surveillance has also been limited.
The Public Health authorities of the State of Oregon have changed several defining factors related to what Lyme disease is in the human subject, therefore the reporting of the disease to the CDC is not consistent with the CDC or the CSTE definitions of the disease and results in many missed cases. These patients are unable to get care, additionally their positive cases are unable to be reported because they do not meet the states definition of Lyme disease.
In 2014, only 44 Oregon patients were reported to the CDC. However Oregon Lyme Disease Network (OLDN), found that a single CLIA laboratory with CDC Proficiency ratings returned 166 Oregon CDC positive unique cases in that same year. Many of those patients were denied care in Oregon because they were not CDC positive or were considered false positive by the public health infectious disease doctors.
The same year OLDN also did a survey of 106 Oregon patients who were being treated for Lyme disease with symptoms and supportive laboratory (some not fully CDC positive). Of these, there were 56 CDC positive with classical presentation of EM rash, flu-like symptoms and migrating joint pain. Only 7% of the 56 were able to get their diagnosis in Oregon due to the restricted definitions, and 2/3 of these patients had diagnosis reversed by public health infectious disease doctors in the state, meaning only 2% of classical and CDC+ (and none of the other group) were able to get care in Oregon were followed up by Public Health and reported to the CDC.
State of Oregon Public health redefined several factors related to what Lyme disease is for both reporting and diagnostics as we discovered in a series of task force meetings with OLDN, Oregon Public Health, Oregon Health Authority, and Senate Health Committee Chair and Dr Maloney, one of the authors listed in the ILADS guidelines, which were accepted into the AHRQ NGC.
- Endemic was changed from 2 incidence per county to 100 per county- per year.
- Physician-documented EM Bullseye Rash and IgM-positive Western blot are required for reporting. (bullseye rash >5 cm in diameter or multiple, smaller, annular lesions) (see §3.3.1, infra).
As also learned in the task force meetings, Oregon Public health policies are clear to physicians through state training curriculum. Theses trainings only reflect Oregon Policy on Lyme disease which is based on the infectious disease society, based on recommendation from the CDC (as stated in their curriculum) However in some cases even more stringent requirements are set forth, and in curriculum provided to providers. One of these includes recommendation that patients need to have serological testing ELISA at the same time as the rash. If ELISA positive, they then send from the same sample to a second laboratory (Utah) for the Western Blot. This causes a delay of more than 72 hours for the antibody testing on the Western Blot. These both have to be positive at the time of the EM rash for reporting to occur. While not in the written publicly available documents, this was discussed in the meetings and our request to drop the requirement of serology when an EM rash is present after a tick bite, our request was denied. This change in the criteria, is uses not only for diagnostic purpose but for reporting as well.
This bastardisation of the reasonably stringent CDC reporting criteria creates significant reporting inconsistencies from state to state-- making any surveillance moot. Why have a surveillance system when each state gets to redefine what we are looking for? It’s like asking each state to count the number of equines in a state, where one state defines equine as a black and white striped equine with donkey like ears, another defines an equine as any four legged animal with a tail and brown muzzle, and so forth. The returned reporting will be different in each state. Would someone who reports a quarter horse be a “false positive” for equine in one state but not the other because they didn’t meet the black and white striped requirement?
Oregon appears to have more “false positives” because in non-endemic areas, positive tests are to be considered “False positive”--we are in an area believed to be non-endemic due to faulty reporting. The CDC shows a clear mapping making assumptions that in non-endemic area 67% of positives are false positive. https://www.cdc.gov/lyme/healthcare/clinician_testResults.html.
To highlight this issue in surveillance in 2014, Only 34 Oregon patients were reported to the CDC. However in a study by Oregon Lyme Disease Network, one single laboratory with High CDC Proficiency ratings returned 166 unique cases for that same year where patients were symptomatic after a tick bite and had CDC Positive Western Blot for Lyme disease.
Because Oregon is not “endemic”, the public, the medical professionals and other are often told its not here. Proper prevention is not considered starting with tick bite prevention, followed by seeking medical help for tick bites. The majority (72%) of the patients we have helped since 2001 have come to us in late stages of the disease, with severe disabilities (misdiagnosed with MS, ALS, autism, CF/FM, psychiatric) and most improve dramatically with treatment from out of state physicians who specialize in Lyme disease. Although with OLDN PSAs and media presence we have started seeing and speaking to patients earlier often at onset of tick bites, they are met with resistance from the medical providers in the state. We have nowhere to send patients in early disease for adequate treatment. Some physicians offer one single doxycycline dose, a few may get up to 2 weeks with no follow up option despite ongoing symptoms.
Because the doctors do not think tick illnesses are an issue, the training is lacking and they are unable to differentiate between relapsing fevers, Bartonella, Lyme, Ehrlichia, Coxiella and other tick infections.
Additionally when these patients begin to progress to neurological disorders, arthritic disorders and cardiac disorders, our physicians do not know how to differentially diagnose for Lyme Disease.
Incidentally Oregon is one of the highest incidence of RH- Arthritis, Autism, MS and ALS in the country, with no offer of differential diagnosis for diagnosis for underlying bacterial etiology. Because it is not endemic, the “no testing, no diagnosis or treatment” philosophy- one supported by our state health- ensure it will continue to remain non-endemic.
This lack of clear and consistent surveillance protocol and state refusal to cooperate with efforts to understand the impacts of this disease in Oregon has caused much suffering. Patients have been severely marginalized especially if they do not have sufficient financial means to get help outside of this state.
In my opinion, we must allow the CDC to work with private organizations who have no conflict of interest, and have public health concerns in their charters. We must engage the communities where we can. And we must provide a mechanism for reporting that is not biased. A mechanism allowing CDC positive test results to be reported to CDC authorities for inclusion in MMWR database. Additionally we need to understand that without change, this this problem will grow exponentially in magnitude.
Theresa Denham, President
Oregon Lyme Disease Network
Written comments for Tickborne Diseases Working Group, Thursday, May 10th, 2018
Firstly, Kudos to the CDC for their new program for alerting public every spring, and for the recent report on increasing incidences of tick-borne diseases! And on new tick-borne viruses, such as the Heartland (Savage et al. 2016) and Bourbon viruses (Kosoy et al. 2015), as well as allergic reactions to eating red meat (Commins et al. 2011)!
Tick-borne diseases of public health importance in western states/Provinces of the US and Canada
Major Question: What is the extent of the tick and tick-borne disease surveillance programs in the western US and western Canada?
For example, Ixodes spinipalpis is a vector of Babesia, Borrelia, and Rickettsia (including Anaplasma and Ehrlichia -- Levine 1971, Keirans and Clifford 1983, Maupin et al. 1994, Schneider et al. 2000, Burkot et al. 2000, 2001, Zeidner et al. 2000, DeNatale et al. 2002, Uilenberg and Goff 2006). In addition, Keirans and Clifford (1983) isolated Powassan virus from this tick in SD. Because this tick species is considered nidicolous (nest-dwelling), it would be expected to spend most of its time on a host or in nesting material; however, immature I. spinipalpis quest for hosts outside of actual nest sites (Burkot et al. 2001, Eisen et al. 2006). In fact, this tick species has been reported to bite humans in MT, OR, and WA (Merten and Durden 2000).
Ixodes spinipalpis is found in 9 western states of the US and Alberta, and British Columbia in Canada (Keirans and Clifford 1983, Durden and Keirans 1996, Lindquist et al. 2016). Adult and immature I. spinipalpis feed on numerous species of rodents, lagomorphs, and sometimes humans; immature stages also feed on birds (Durden and Keirans 1996, Scott et al. 2015), as we have also seen in recent collections of nymphs from migratory birds sampled during September of 2016 and September and October of 2017 in two counties (Adams and El Paso) in CO. This species appears to be a potential threat to public health in the western US and Canada.
Another, more well-known tick of interest is Dermacentor andersoni – the Rocky Mountain wood tick; it is the primary vector of the Colorado tick fever virus (Emmons 1988); as well as the agents of Rocky Mountain spotted fever and tularemia (Burgdorfer 1969) in the western US. It also is the main cause of tick paralysis in the western US and western Canada and is an experimental vector of the agents of Q fever (Davis 1938), and bovine and ovine anaplasmosis (Yunker et al. 1986, Kocan and Stiller 1992). Powassan virus has been isolated from SD populations of this tick (Keirans and Clifford, 1983). In the USA, it occurs in the West (James et al. 2006); in Canada it occurs in British Columbia, Alberta, and Saskatchewan (Lindquist et al. 2016). It is the tick most commonly encountered by humans and companion animals in the western US and Canada (Eisen 2007).
Question: Is there surveillance work being done on soft ticks (family Argasidae) in the US and Canada?
Ornithodoros hermsi is the primary vector of one of the two principal North American agents of tick-borne relapsing fever (TBRF, Borrelia hermsii ) in humans (Lopez et al. 2016), which circulates sylvatically in rodents. People usually are bitten as they sleep in rustic mountain cabins that are, or have been previously infested with rodents and, because of the painless and transient nature of this tick feeding, victims may not be aware of having been bitten (Johnson et al. 2016). Documented outbreaks of TBRF have occurred at vacation cabins CO (Trevejo et al. 1998); AZ (Paul et al. 2002); and CA (Schwan et al. 2009). This tick occurs widely in the western USA, with collections documented in 10 US states (Dworkin et al. 1998, 2008) and British Columbia, Canada (Lindquist et al. 2016).
Last Question: Are there tools being used that could identify ticks and pathogens simultaneously, such as Matrix Assisted Laser Desorption Ionization –Time of Flight Mass Spectrometry (MALDI-TOF MS) (Yssouf et al. 2015)?
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Dr. H. Joel Hutcheson,
Vector Biologist, Centre for Vector-borne Disease,
National Centre for Animal Diseases, Canadian Food Inspection Agency
My name is Lonnie Marcum. I live in California and am a physical therapist by training. I became a Lyme advocate after my daughter was diagnosed with Lyme and co-infections in 2013—this after going nearly a year with an undiagnosed infection. These comments are an expansion of my verbal comments submitted to the TBDWG for the May 10, 2018 meeting (see attached).
California has one of the most diverse ecosystems in the world. The terrain ranges from sea level—with 840 miles of Pacific coastline; to the extremes of Death Valley—North America’s hottest, driest, lowest point; to Mount Whitney—the highest summit in the contiguous United States.
Along with this diverse terrain comes a high level of biodiversity, and with it 48 species of ticks—almost half of the known tick species in the United States. This means California is a prime breeding ground for tick-borne diseases .
But the CDC has come to view California as a low-risk state for Lyme disease even though Allen Steere reported otherwise in 1979:
“Lyme disease, defined by erythema chronicum migrans and sometimes followed by neurologic, cardiac, or joint involvement, is known to have affected 512 patients in the United States. The disease seems to occur in three distinct foci: along the northeastern coast, in Wisconsin, and in California and Oregon, a distribution that correlates closely with that of Ixodes dammini in the first two areas and with Ixodes pacificus in the last .”
Lyme is the tip of the iceberg
World-renowned medical entomologist Dr. Robert Lane has studied California ticks for over 40 years. His many accomplishments and pioneering tick studies include: the discovery of Borrelia bissettii (later named bissettiae) in California ; the identification of the western gray squirrel as the primary reservoir host for Lyme disease in California woodlands ; and his legendary 1982 collaboration with Dr. Wihelm (Willy) Burgdorfer on the first large-scale study of North American ticks—which identified Ixodes pacificus as the vector for Lyme disease in CA . But Lyme is only one of myriad tick-borne problems that plague Californians.
Recently, Dr. Lane and I spoke at length about the number of known pathogens carried by California’s diverse ticks. Besides Lyme disease, the Ixodes pacificus tick (Western black-legged tick) can transmit many potentially fatal infectious agents, including:
- Anaplasma phagocytophilum,
- Babesia duncani,
- Ehrlichia chaffeensis,
- Borrelia (B. americana, B. burgdorferi, CA382, CA-11-2A, CA8)
- Relapsing fever Borreliosis (B. bissettii, B hermsii, B. miyamotoi, B parkeri).
Professor Lane, along with researchers at UC Berkeley and Yale, recently published a study examining a biobank of frozen blood samples from the 1980s, collected from residents of Mendocino County, CA. The results were astonishing. Twenty-six out of 101 samples were reactive for relapsing fever borreliosis, including B. miyamotoi—a bacteria that lacks both a standardized test and CDC surveillance. In addition, confirmatory blood tests showed 79% of those people had antibodies to tick saliva—a rate nearly three times that of residents of Block Island, Rhode Island, where 29% carry the antibodies .
According to the California Department of Public Health (CDPH), many pathogens transmitted by California ticks are known to cause illness in humans .
The illnesses caused by these pathogens include :
- Borrelia miyamotoi disease
- Colorado tick fever virus
- Lyme disease
- Rocky Mountain spotted fever
- Spotted fever Rickettsia
- Tick-borne relapsing fever borreliosis
- Tick paralysis
New reporting criteria harms low-incidence states
Many people consider Lyme disease an “East Coast thing.” Thus, it is often overlooked by physicians in the West, simply due to lack of knowledge. That lack of knowledge is partly responsible for the under-reporting of Lyme, but there are other obstacles. Californians sickened after a tick bite, not only have to find a physician willing to test for Lyme, but then each case must pass several strict checkpoints before making it to the CDC.
Up until recently, California physicians could report Lyme cases based upon tick exposure in a county known to carry Lyme, followed by an erythema migrans (EM) “bull’s-eye rash,” OR a positive 2-tier blood test . Note: Lyme-infected ticks have been documented in 42 out of 58 California counties .
Under the new 2017 CDC criteria, an EM rash is only diagnostic if the patient was exposed less than 30 days prior, in a “high-incidence” state. A high-incidence state is now defined as one that averages 10 confirmed cases per 100,000 population. In 2015, 90% of all “confirmed” cases of Lyme disease were reported in 14 states. 
The CDC states: “Furthermore, Lyme disease is endemic in certain areas of the Pacific Coast that support the enzootic cycle, and although risk is documented in those areas, no states outside of the Northeast, mid-Atlantic, or upper Midwest regions met the criteria for high incidence.”
Today, inside of these 14 “high-incidence” states, an EM rash is considered diagnostic. In the other 36 states, all cases must be confirmed by a positive 2-tier blood test in order to be included in the CDC surveillance.
High risk areas of California
In 2006, Dr. Lane and other researchers at UC Berkeley and the California Department of Public Health (CDPH) documented counties in California that are endemic for Lyme disease, with up to 15% of ticks  carrying Borrelia, and up to 50 cases per 100,000 population .
From 2005 to 2014, the highest incidence of Lyme in California occurred in Trinity County, which is in the northern part of the state. In an earlier study, Dr. Lane concluded that Mendocino County, California, was as endemic as highly endemic areas in the Northeastern US.
For reference, Mendocino County, CA is almost twice the size of Delaware and three times larger than Rhode Island. Yet under the new reporting criteria, cases even in highly endemic areas of CA are less likely to be counted by the CDC. While the risk of contracting Lyme in many areas of CA is quite high, all cases will be held to the standards of a low-incidence state.
This means, in California, even if you have the diagnostic EM rash, your case will not be reported to the CDC unless you get a confirmatory positive result on both of the 2-tier blood tests.
There are two glaring problems with this:
- The 2-tier blood test is only 59% sensitive to Lyme disease .
- The standard test for Lyme will miss eight of California’s nine species of Borrelia.
Surveillance criteria are for surveillance
It is very important to know the difference between surveillance criteria and making a diagnosis of Lyme disease. Surveillance criteria are purposely stringent, so that the CDC can positively track the spread of disease. But even the CDC acknowledges something is off with the criteria.
In 2013, after conducting three separate studies, the CDC estimated the actual incidence of Lyme disease in the United States to be 10 times higher than the number of cases reported annually . The chief epidemiologist for the CDC’s Lyme disease program said, “We know that routine surveillance only gives us part of the picture, and that the true number of illnesses is much greater.”
The CDC clearly states that its surveillance criteria are not to be used to rule out a diagnosis of Lyme disease, because it takes several weeks for patients to produce enough antibodies for the test to show positive. With early treatment being so critical, a diagnosis needs to be made based upon clinical signs and symptoms.
Per the CDC: “A diagnosis of Lyme disease should be considered in patients with compatible clinical signs and a history of potential exposure to infected ticks, not only in states with high incidence but also in areas where Lyme disease is known to be emerging..”
California, along with many other states that fall below the 10 per 100,000 case cutoff, wind up in a vicious cycle: Decreased awareness leads to decreased testing, which leads to no listing on the CDC surveillance maps, which leads to doctors thinking, “We don’t have Lyme disease in (insert your state).”
Due to the lack of awareness and education, the true incidence of Lyme and tick-borne diseases has been greatly under-detected. Because patients with tick bites are rarely tested for the full range of tick-borne pathogens, we really have no idea what is making them sick. Could undiagnosed Powassan, or some yet to be discovered virus, be contributing to the high percentage of Lyme patients with chronic symptoms?
The latest “Vital Signs” from the CDC reports over 75% of the 650,000 cases of vectorborne disease during 2004-2016 came from ticks, with Lyme disease accounting for 82% of all tickborne cases. Given that Lyme disease is the fastest growing vectorborne disease in the continental US, and the ability of ticks to transmit multiple pathogens the CDC needs to launch a robust public health response, at least to the level of mosquito borne diseases.
While I understand the CDC’s need to verify the spread of pathogens through highly specific confirmatory blood tests, this does nothing to help patients receive early effective treatment for tick-borne diseases.
What patients need is a highly sensitive test, capable of early detection of all tick-borne pathogens. Today we have the technology to make this happen. In fact, there are multiple laboratories already working on these tests. I suggest we give them every opportunity to succeed!
- Conduct tick studies in every U.S. county, map the pathogens and make them public.
- Develop a single test that is capable of detecting all tick-borne pathogens in humans.
- Make all tick-borne diseases reportable illnesses in every state.
- Require tick-borne disease education in all medical schools.
- Increase public health funding for tick-borne disease in every state.
- Furman DP, Loomis EC. The Ticks of California (Acari: Ixodida). Bulletin of the California Insect Survey. Volume 25. https://essig.berkeley.edu/documents/cis/cis25.pdf
- Steere AC, Malawista SE. (1979) Cases of Lyme disease in the United States: locations correlated with distribution of Ixodes dammini. Annals of Internal Medicine. https://www.ncbi.nlm.nih.gov/pubmed/496106
- Postic D, Ras NM, Lane RS, Hendson M, Baranton G. (1998) Expanded diversity among Californian borrelia isolates and description of Borrelia bissettii sp. nov. (formerly Borrelia group DN127). Journal of Clinical Microbiology. http://jcm.asm.org/content/36/12/3497.long
- Lane RS, Mun J, Eisen RJ, Eisen L. (2005) Western gray squirrel (Rodentia: Sciuridae): a primary reservoir host of Borrelia burgdorferi in Californian oak woodlands? Journal Medical Entomology. May;42(3):388-96. https://www.ncbi.nlm.nih.gov/pubmed/15962792
- Burgdorfer W, Lane RS, Barbour AG, Gresbrink RA, Anderson JR. (1985) The Western Black-Legged Tick, Ixodes Pacificus: A Vector of Borrelia Burgdorferi. The American Journal of Tropical Medicine and Hygiene. Volume 34, Issue 5. DOI: https://doi.org/10.4269/ajtmh.1985.34.925
- BorreliaBase. A Phylocentric Browser of Borrelia Genomes. Available here: http://www.borreliabase.org Assessed April 28, 2018.
- Krause PJ, Carroll M, Fedorova N, Brancato J, Dumouchel C, Akosa F, Narasimhan S, Fikrig E, Lane RS. (2018) Human Borrelia miyamotoi infection in California: Serodiagnosis is complicated by multiple endemic Borrelia species. PLOS One. https://doi.org/10.1371/journal.pone.0191725
- Green G, Kjemtrup A, Ferris M. (2014) Local Frontiers: Tick-borne Infections in California. Sonoma Medicine. http://www.nbcms.org/about-us/sonoma-county-medical-association/magazine/fall-2014-medicine-and-politics-special-reports-local-frontiers-tick-borne-infections-in-california.aspx?pageid=713&tabid=747
- Epidemiology and Prevention of Tick-borne Diseases in California. Information for Physicians and Other Health-Care and Public Health Professionals. Available at: https://www.cdph.ca.gov/Programs/CID/DCDC/CDPH%20Document%20Library/EpidemiologyandPreventionofTBDinCA.pdf Accessed: April 28, 2018.
- Centers for Disease Control (CDC) National Notifiable Disease Surveillance System (NNDSS): Lyme disease (Borrelia burgdorferi) 2017 Case Definition. Available at: https://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2017/ Accessed April 28, 2018.
- Centers for Disease Control (CDC) Lyme Disease: Data and Statistics. Available at: https://www.cdc.gov/lyme/stats/index.html Accessed April 28, 2018
- University of California Statewide Integrated Pest Management Program (UCIPM): Lyme Disease in California. Revised 5/16.
- Eisen RJ, Lane RS, Fritz CL, Eisen L. (2006) Spatial Patterns of Lyme disease Risk in California Based on Disease Incidence and Data Modeling of Vector-Tick Exposure. Am Society of Tropical Medicine and Hygiene. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.518.4342&rep=rep1&type=pdf
- Cook MJ, Puri BK (2016) Commercial test kits for detection of Lyme borreliosis: a meta-analysis of test accuracy. Int’l Journal of General Medicine. https://www.dovepress.com/commercial-test-kits-for-detection-of-lyme-borreliosis-a-meta-analysis-peer-reviewed-fulltext-article-IJGM
- Centers for Disease Control and Prevention. (2013) Press Release: CDC provides estimate of Americans diagnosed with Lyme disease each year. https://www.cdc.gov/media/releases/2013/p0819-lyme-disease.html
- Schwartz A., Hinckley A., Mead P. et al., Surveillance for Lyme disease, United States, 2008 – 2015. MMWR Surveill Summ. 2017 Nov 10;66(22):1-12. doi: 10.15585/mmwr.ss6622a1
- Rosenberg R, Lindsey NP, et al. (2018) CDC: MMWR. Vital Signs: Trends in Reported Vectorborne Disease Cases — United States and Territories, 2004–2016. https://www.cdc.gov/mmwr/volumes/67/wr/mm6717e1.htm?s_cid=mm6717e1_w
In my previous written and verbal remarks to the TBD Working Group (February meeting) I detailed my daughter’s ten year ordeal to obtain a diagnosis of Lyme in the “non-endemic” Atlanta area and subsequent non –existent and dismissive treatment by the local medical community. Ten years on after numerous relapses of Lyme related illness, she has made great strides as she is being treated by knowledgeable and caring medical professionals – the majority outside of metro Atlanta.
My remarks for this gathering will address financial and emotional tolls upon the family of the Lyme patient. As stated above, the majority of treatment was undertaken outside of Georgia with responsibility for payments being borne by the family, since insurance companies denied coverage based upon a “false positive” IgM Western Blot.
Over the ten years my daughter has been treated for Lyme, we have spent approximately $60,000 out of pocket. The majority of this came about in the first years after diagnosis. After a relapse following oral medications, we agreed to an IV antibiotic regimen resulting in significant improvement that enabled our daughter to complete a rigorous college engineering degree. While insurance assisted with oral medications, we were left to cover all expenses for the IV protocol and office visits. I vividly remember being stunned when we left the doctor’s office after an appointment with the IV medications and associated medical paraphernalia totaling $9000, which we had to put on our credit card. At the completion of six months of IV treatment, we had spent approximately $40,000.
Additional monies were allocated for co-pays, travel, and lodging as medical practices were located some distance from our home. Also, due to her illness, having to drop college courses, and loss of academic scholarships, her graduation date extended to seven years considerably multiplying college expenses. Family bankruptcies, due to medical expenses, are taking a toll not only on Lyme sufferers, but many other American families dealing with chronic illness. We were fortunate not to have to declare bankruptcy, but it cost us the majority of our family savings, leaving us with significantly less for emergencies and retirement.
When dealing with chronic illness, early diagnosis and appropriate treatment are paramount to restoring health and well-being to patients and families. In our situation, treatment for our daughter was delayed approximately a year due to a false positive Western Blots. Had the represented Lyme flagellum 41 band both IgM and IgG specific positive bands not been ruled false positive, treatment would have begun early, after the initial infection was flagged. Perhaps with an earlier intervention, our daughter would not be suffering today and our family would not have come close to filling bankruptcy and depleting our savings.
Physically and emotionally, over the past ten years, our family has run the gamut of dealing with extreme highs and lows. We have witnessed the terror of our daughter barely being able to walk and watched her struggle with debilitating fatigue. We have suffered through the battle of our first year, dean’s list, daughter for seven hard years to complete her collegiate career, wondering if she would be able to prevail. From the time she contracted Lyme, through college and on to this day, we console her as she suffers recurring malaise, pain, remorse that she is afflicted, and disbelief that this widespread disease hasn’t received greater recognition with resulting research into effective medical treatment for innocent victims of the disease. For the most part, she has and still suffers with having to convincingly detail and explain her condition to others, many of whom do not easily believe her. In addition, she has been forced to try to fit into and fight through a world where her disease is invisible, and where she was so radically different from everyone else--the carefree college student she should have been and now the professional working engineer. To accomplish this she still depends on our support, both emotionally, as a sounding board, and sometimes financially, while we encourage her to persevere and to maybe eventually, reach wellness to transition from an abnormal to a normal life.
It is excruciatingly painful to witness, in person, a vibrant child decline both physically and emotionally while suffering at the hands of physicians stating that the symptoms are imaginary. It is difficult to imagine the crushing distress of a plethora of doctors universally adhering to a dogma, dictating to a diseased, suffering patient with Lyme Disease that the individual is not sick because 1) Lyme Disease only exists in certain locations far from where the patient resides, 2) since the multi-symptomatic, ill patient does not present, with a specific few symptoms or test results exactly as outlined in disease guidelines, based on flawed criteria, that the patient definitively cannot have the disease, and 3) with no evidence of disease, patient symptoms actually do not exist and that psychiatric physician assistance be sought, verbally and in writing, citing that “it’s all in the patient’s head.” Patients often have nowhere to turn except to family for physical, emotional, and financial support to persist in seeking a diagnosis, or suffer in silence as the disease goes unchecked, inflicting further damage. We received many late night and early morning phone calls from a scared and distraught twenty year old college student pleading for advice and support as she “couldn’t take it anymore” and wanted to drop out and return home.
Emotionally consoling a child in the early morning hours and then getting up and ready for work takes a toll on the parents also. Our lives were now being dictated by the health of our child. We could no longer anticipate the traditional milestones of a young healthy adult. Landmarks of transition such as college graduation, socializing with friends, and being healthy were adversely affected as they took a back seat to the disease afflicting our young daughter. As her parents, we supplied strong emotional support. Visits to her at school and accompanying her to numerous doctor appointments served to bolster her fragile psyche. We contacted her university and established a 504 plan that allowed for special waivers for completing coursework and examinations. There was not a single day during the long seven years of our daughter’s college stead that she was not forefront in our mind. The memories of the phone ringing at 2:00 A.M with a distressed and frightened young woman on the other end still linger to this day.
Lyme and other chronic illnesses exact a physical, emotional and financial toll on patients and their families. Physically, patients are debilitated as they go through their everyday lives. Fatigue, pain, and cognitive dysfunction are only a few examples of an altered lifestyle these patients endure. Emotionally, many patients and families become socially isolated as their only goal is a return to health for the afflicted at a cost to a “normal” life. Patients are also ostracized by a medical community lacking knowledge, compassion and/or an appropriate skill set to deal with these patients. Finally, there is a real financial burden placed on patients and their families dealing with chronic illness. Too many families are forced into bankruptcy or loss of life savings as they struggle to return health to their loved ones.
I hope the committee will see our struggles as not of only one family, but representative of many families dealing with Lyme and other chronic illnesses. Thank you for you dedication.
May 3, 2018
Dear HHS Tick-borne Disease Working Group:
Following my public comments for the meeting of December 11 & 12, 2017, I submit the following comments and public request as someone who has lived and languished with Post-treatment Lyme Disease which was contracted in my 20 (1980s) but was not diagnosed until I was 37 (1995). Despite treatment with long-term oral antibiotics by an infectious disease specialist, I was left with a progressive remitting and relapsing disease course which has affected my brain (central, peripheral and autonomic nervous systems), heart, skin, muscular-skeletal system, hearing (loss), immune system (CD4/CD8 ratio of only 0.46 as in advanced HIV AIDS), gastro-intestinal system and genitor-urinary system with debilitating fatigue I have lived all over the United States and spent my early years in the Ohio Valley, Pennsylvania (Allegheny County) and Wilmington, Delaware, Portland, Oregon, and Kansas City. I have lived in NSW Australia, approximately 110 kilometres north of Sydney since January 2000 after my marriage to an English man who was resident of Australia. My post-treatment Lyme Disease with progressive remitting/relapsing symptoms has not been recognized in Australia and has now caused significant problems as a result both in the management of my chronic illness and when I finally reached a point where even part-time work was no longer possible, as a result, despite a bilateral social security agreement with Australia, my disability claim was denied and has been appealed at multiple government levels, but has been argued by Australian government lawyers that there is no such thing as persistent Lyme Disease, despite the fact that Allen Steere and colleagues as early as 1990 had followed patients from 1978-1990 and chronicled "chronic manifestations of neurological Lyme Disease which was thought to be due to failure to eradicate spirochetal infection or irreversible Sequela from tissue damage.
"Six months after treatment, more than one third had relapsed or were no better. In addition, more than half had previously received antibiotic therapy thought to be appropriate for their stage of disease and still had progression of the illness. The likely reason for relapse is failure to eradicate the spirochete completely.....On the other hand, the patients whose conditions did not improve may have had irreversible damage to the nervous system, particularly since therapy tended to be worse in patients with longer duration of disease. This is reminiscent of far-advanced neurosyphilis, in which the response to penicillin may be minimal." (Steere et al, page 1443, last paragraph of article, attached)
In 2014, the CDC held a webinar on Lyme Disease persistence and attributed ongoing disease progression in animals and humans (see page 32 of seminar slides attached) to either: 1) induction of inflammatory response by dead spirochetes or spirochetal antigen; 2) Continuation of active spirochetal infection; 3) irreversible Sequela from previous active infection (autoimmune)
The results of a study with 5,357 Lyme Disease patients with persistent symptoms (attached), as evidence of disease severity compared to other diseases, titled Severity of Chronic Lyme Disease Compared to other Chronic Conditions: A Quality of Life Survey found that patients with chronic/post-treatment/persistent Lyme Disease experienced fair or poor health as a function of time, with 77% of patients experiencing fair or poor health after 10+ years of illness and that the severity of symptoms which include: Fatigue; sleep impairment; joint pain; muscle aches; other pain; depression; cognitive impairment; neuropathy; headaches; and heart related problems, with the number of healthy days with vitality as less than 5 within a given month.
Post-treatment/chronic/persistent Lyme Disease is a disabling condition and should be recognized by the United States, where it was first discovered, as a valid disability under the Americans for Disability Act and included in the Federal Register as a disabling condition. While Lyme Disease is considered a disability on a case-by-case basis, disability is often very hard to be approved because of poor medical documentation, with many very ill people being denied. It is currently not in the Federal Register as an officially approved disability like Chronic Fatigue Syndrome, which many late Lyme Disease sufferers with progressive persistent symptoms would argue is far more debilitating, with fatigue (post exertional, exertional and general exhaustion) as just one of many debilitating symptoms. It is imperative that persons with post-treatment Lyme Disease/Chronic, persistent and progressive symptoms be recognized for their debilitating illness/disability and hence recognition in the Federal Register.
Moreover, the Secretary of Health and Human Services should send a communiqué to all foreign governments with whom the US has a bilateral social security totalization agreement of this fact and to put them on notice that under the agreement they should recognize this illness as a disabling chronic illness under the bilateral social security agreement with the United States so that American citizens who are residing abroad are eligible for disability benefits regardless if Lyme Disease is endemic in the country with whom the US has the bilateral agreement. Finally, patients with persistent symptoms should be followed for the duration of their illness through end of life with appropriate medical follow-up for both disease progression and pathogenesis including immune system response, with measurements of CD3, CD4 and CD8 counts, CD4/CD8 ratios and any other relevant measurements regarding recent research dating back to Allen Steere's 1998 research on T Cells in patients with Chronic Lyme Disease. In addition, attempts should be made to isolate the organism or its DNA in patient tissue samples or at autopsy and information should be voluntarily entered into national data-bases such as MyLymeData intended toward finding commonality in disease progression with the ultimate aim of finding a cure for those whose disease follows a progressive course.
- US/Australia - Bilateral Social Security Totalization Agreement https://www.ssa.gov/international/Agreement_Pamphlets/austrlia.html
- Chronic manifestations of neurological Lyme disease (1990, Allen Steere et al) http://www.nejm.org/doi/full/10.1056/NEJM199011223232102
- 2014 CDC Webinar on Lyme Disease Persistence (Slide Presentation refer to slide page 32 on causes of Lyme Disease Persistence) http://www.cdc.gov/lyme/pdfs/PersistenceWebinarSlides.pdf
- 2014 CDC Webinar on Lyme Disease Persistence (Audio Presentation with slides): https://www.youtube.com/watch?v=Xzuwv3OkMBA
- 2014 CDC Webinar on Lyme Disease Persistence (Transcript) https://www.cdc.gov/lyme/pdfs/PersistenceTranscript.pdf
- 2014 CDC Webinar on Lyme Disease Persistence (Presenters) https://www.cdc.gov/lyme/resources/May2014_HHS_Lyme_Disease_webinar_mazarin_508.pdf
- Identification of a T Cell Subset Capable of both IFN-γ and IL-10 Secretion in Patients with Chronic Borrelia burgdorferi Infection (1998, Allen Steere et al) http://www.jimmunol.org/content/160/4/1804
- T Cells Exacerbate Lyme Borreliosis in TLR2-Deficient Mice (2016, Charles Brown et al) https://www.ncbi.nlm.nih.gov/pubmed/27857714
- Severity of chronic Lyme disease compared to other chronic conditions: a quality of life survey (2014, Raphael B Stricker et al) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3976119/
- Distinct Cerebrospinal Fluid Proteomes Differentiate Post-Treatment Lyme Disease from Chronic Fatigue Syndrome (2011, Steven E Schutzer https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3044169/
- Social Security Ruling, SSR 14-1p; Titles II and XVI: Evaluating Claims Involving Chronic Fatigue Syndrome (CFS) https://www.federalregister.gov/documents/2014/04/03/2014-07465/social-security-ruling-ssr-14-1p-titles-ii-and-xvi-evaluating-claims-involving-chronic-fatigue
May 3, 2018
As a Missouri resident, I am requesting transparency on TBD surveillance data.
A bulletin was released by the Missouri Department of Natural Resources on 6/29/2017 stating:
"Tick study under way at Meramec State Park
JEFFERSON CITY, MO, JUNE 29, 2017 – On Monday, the Centers for Disease Control and Prevention and the Missouri Department of Health and Senior Services began a systematic effort to trap and collect ticks at Meramec State Park. Following the collection process, the agencies began testing the ticks for any kind of tick-borne illness."
This was subsequent the suffering and death of Tamela Wilson, state park worker who tested positive for Bourbon virus.
Only results for Bourbon virus in the ticks have been released.
What other testing was done, by what department, and what were the results?
The lone star tick belt has not had adequate surveillance, especially for prevalence of Borrelia other than burgdorferi. Dragging and testing major outdoor recreational areas, such as August A Busch Memorial Conservation Area (deer), Katy Trail, and Lake of the Ozarks, areas known for hiking, biking, boating, fishing and picnics, could provide updated information.
What policies are in place to insure public access to surveillance data, of TBD in both ticks and humans?
Meramec state park workers were offered blood testing for Bourbon virus.
Were they notified of their results?
What policies are in place to insure those people tested for surveillance have access to their own data, so that we can avoid an unintentional Tuskegee experiment?