TBDWG June 21, 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 June 2018 meeting.
To the HHS TBDWG,
The United States must develop a pro-active forward looking approach in response to the increasing and spreading scourge of TBDs in the US. Serious worldwide threats abound, some are certain to reach our shores. H.longicornis should serve as a wake-up call along with news about other serious worldwide pathogens such as Crimean Congo Hemorrhagic Fever, Tick-Borne Encephalitis, etc. and many other tick species are threats on the horizon.
Current research is delivering increasingly viable options for which we must investigate mass applications. Nootkatone, SPLAT TK, and bait vaccines for reservoirs (Lyme, anti-tick, etc.) all show great promise for broad usage. We need to assist by supporting rapid development to bring them to actualization. Longer more complete approaches are RNAi, microbiome, transgenic ticks, etc.
More details on this can be found in the report of the HHS TBDWG Subcommittee on Disease Vectors, Surveillance and Prevention.
Tick research has been a long-ignored field of science, yet it holds the most promise to bring about fruitful solutions that can prevent a catastrophe from worldwide TBDs and ticks. Tick Research to Eliminate Disease (TRED) a coalition of 40 prestigious scientist members in unilaterally support the critical importance for tick research and call for this to become a priority. It makes it your duty as the HHS TBDWG to include it equally with other recommendations to the HHS Secretary.
The time is now!
Regarding the Vaccine & Therapeutics Subcommittee
Putting The Cart in Front of the Horse Are We?
In 2005, Johns Hopkins published a study indicating lab tests for Lyme disease missed approximately 75% of the people who were infected. (1)
Over a decade later, a study by Michael Cook, et. al. determined 74.9% of those infected had false-negative Lyme test results. (2)
Obviously, Lyme tests are NOT any more accurate today than in the past.
In fact, many medical professionals on the front lines treating the growing number of chronically ill patients believe the percentages of missed Lyme cases are much higher- up to 90%.
When conclusions in scientific studies are based on results of inaccurate Lyme tests, the study's conclusions will be flawed. When the same flawed studies and same flawed tests are used in the development of a Lyme vaccine, the vaccine can't help but be seriously flawed.
Stakeholders who have vehemently pushed to keep the failed Lyme tests on the market to the exclusion of others (3) are also involved with and are dependent on the success of the vaccine. (4)
This new (recycled) Lyme vaccine currently in clinical trials is projected by Valneva to be worth approximately $900,000,000 (U.S. dollars) annually.(5) Its review and subsequent approval is being determined by the same stakeholders who continue to promote and profit from the failed Lyme tests.
Although the promise of nearly one billion dollars a year is inviting, there should be no Lyme vaccines approved, mandated or distributed until there are accurate Lyme tests on the market.
It’s that simple.
Beth Carrison-van der Heide
Dear TBDWG -
First, I'd like to thank you for all the work you've done regarding tick-borne conditions. Recommending to expand the language in which the research is currently being conducted is key to successfully finding answers for all tick-borne conditions.
In reviewing the working documents in May, the language started to narrow once again throughout many areas of the recommendations planned for the report to Congress. Although, the language within the subcommittee titled “Other Tick-Borne Diseases and Co-Infections” seemed to be expanding in nature, and favorable supporting needed research for Alpha-gal and other conditions, I'd like to again encourage the committee to again review the language in ALL AREAS of the report to be presented to Congress.
I’d like to invite you all to watch the 5/30/18 international webcast regarding Alpha-gal Syndrome. You will hear from the founding physician from Australia, Dr. Sheryl van Nunen and US physician, Dr. Tina Merritt and a patient from S. Africa and the US, along with other experts. Please visit: https://www.facebook.com/tajtalk/videos/1839436192779345/. I’m sure you fill find it both fascinating and educational - dare I say “entertaining”:)
Moving on, I’d like to draw your attention to new information regarding Alpha-gal Allergy/Syndrome.
- See: https://medicalxpress.com/news/2018-06-link-allergen-red-meat-heart.html
- This study is supported by the National Heart, Lung, and Blood Institute, and claims it has linked sensitivity to an allergen in red meat to the buildup of plaque in the arteries of the heart.
- In the current study, researchers showed for the first time that a specific blood marker for red meat allergy was associated with higher levels of arterial plaque, or fatty deposits on the inner lining of the arteries. The blood marker they identified is a type of antibody (immunoglobulin or IgE) that is specific to the alpha-Gal allergen.
- "While more studies are needed, the current work provides a potential new approach or target for preventing or treating heart disease in a subgroup of people who are sensitized to red meat," said Ahmed Hasan, M.D., Ph.D., a medical officer and program director in NHLBI's Atherothrombosis & Coronary Artery Disease Branch.
Many of our Alpha-gal support group members have been reporting heart flutters, blood pressure drops (not related to an allergic reaction) which have all been excused away as “in our head”, “anxiety” etc. However, “coincidentally” several have had heart surgeries due to blockages. We now thankfully have supporting evidence which may help prevent unnecessary further damage. But, without proper documentation by the CDC, and education to health care providers, this will not become known when treating patients with Alpha-gal Syndrome leaving those with this condition at risk unnecessarily. This is a major gap in research with regards to Alpha-gal Syndrome.
I’d also like to support the recommendation which I believe was made by Dr. Horowitz, for patients to be more completely supported by their physicians. In the case for Alpha-gal, patients often find themselves with co-infections, and with subsequent ailments such as nutritional deficiencies and additional new allergies. Now, we also know heart health is a concern from the recent findings reported above.
The ripple effect to our overall health is often impacted in ways most physicians are not readily equipped to identify, test and/or treat. Education of all health care providers regarding the many effects of an individual diagnosed with Alpha-gal and the subsequent health concerns after diagnosis that crop up, will help prevent unnecessary health issues.
In my case, I was fortunate to have financial means to seek help from another physician which required me to pay out of pocket. It was found later found I also had Lyme Disease, and was depleted in many nutrients, and had also developed two new food allergies to white beans and kidney beans which I had been eating to help supplement protein due to my required dietary changes stemming from Alpha-gal. My primary physician had told me to simply “take a histamine - you’ll never figure it out.” - for years! My primary physician also refused to test me for Lyme although I had the classic bullseye, and prescribed only the prophylactic, 1 dose of doxycycline. After 3 years of reporting issues and becoming sicker and sicker; extreme hair loss, exhaustion, joint pain, muscle cramping, hair loss, headaches, mood swings etc. I finally sought another physician and was properly diagnosed and treated. (I no longer see the same primary physician. My trust had been broken completely.)
In addition to all areas previously discussed regarding Alpha-gal (see above and the many other written commentary and verbal commentary provided), the Alpha-gal community would like to ask you to be mindful of the emotional toll it takes on the individual and family. Here are several examples of areas we deal with daily.
- Marriages have failed.
- Shared parenting issues “explode” when one parent or a grandparent does not adhere to the mammal-free / Alpha-gal safe lifestyle required leaving the child at risk for anaphylaxis, and other allergic response (IE> GI distress/diarrhea at school resulting in emotional difficulties.).
- Legal battles; disability and health and life insurance claims denied.
- Loss of jobs or promotions. (due to hindered abilities, accommodation requests, missed time from work etc.)
- Trouble at school - grades, missing days, battles with parents and administration trying to keep a child safe and understand how pervasive Alpha-gal actually is. (This is extremely difficult since the documentation is not widely available - nor is the research robust enough. However - this does not excuse our obvious anaphylactic reactions, hives and other allergy reaction symptoms. Still, we have no resource due to the lack of documented science surrounding Alpha-gal.)\
- Difficulties being heard or understood by our health care practitioners, providers, pharmacists, employer, friends and family is often not accepted, but rather creates more hostility and disbelief and mistrust - on both sides. FYI: Many members stop going to their doctors for basic routine exams and/or when sick because it’s such a struggle. Because of the lack of education, they issue medications which are not Alpha-gal free, and when you are sick --- you just don’t want to fight this fight!
- Starting a new relationship is exceptionally complicated due to the manner in which a patient has to now live.
- Finding or maintaining employment is very difficult for many. Some have been declined due to the allergy because reasonable accommodations are not adequate within their line of work. IE> Working at Walmart with airborne exposure to Subway, or an office worker exposed to microwaved bacon, or other mammalian items.
- Farmers no longer able to work with their livestock or reactions from fertilizers containing manure.
- Teachers unable to remain in the school building due to cafeteria airborne exposure or within their lab areas.
The bullets above are just a few of the daily concerns we hear from those dealing with Alpha-gal. The examples are endless. Please keep in mind many of us had no other health issues or if any, very small health concerns prior to being bitten by the tick. The ripple effect to one’s mind, body and spirit, is wide and not just isolated to the financial ripple effect which was demonstrated in part on the 2/12/2018 verbal comments. (2/12/2018 Speeches can be found at: https://www.youtube.com/channel/UCLZqOfs62ADV5g0LrpInr5Q ---- For anyone reading that is interested, you may request a copy of the presentation shown in this video, which contains links by sending me an email at: firstname.lastname@example.org)
This has to change. I’m encouraged by the work your group has done so far and pray that Congress accepts the recommendation. My fear is Alpha-gal and other tick-borne conditions will be excluded which will leave us all no better off than when you first started your process.
It's my hope you will review the language to ensure Alpha-gal and other tick-borne conditions, defined as a disease, virus, condition, ailment etc., are ensured inclusion in funding for complete research of the full mind, body and spirit connection.
Thank you once again for your time, dedication and passion to fix the many problems needed to expand the research to include all tick-borne conditions, and the many areas of additional research for each condition.
Beth Carrison-van der Heide
Tick-borne Conditions United
"Just when you thought I couldn't get any deeeper into the Lyme realm...guess again. If you read up on the taxonomy of Borrelia Burgdorferi, you will see that it falls in the order of "spirochaetales". But, did you know there's also Mycoplasmatales, Brevinematales and Rickettsiales? Yep, all of these cross into the Actinomycetales order. Actinomycetales are a diverse group of bacteria with morphological properties that contain bacteriophages. If you look into these "orders" you will find the "co-infections" we deal with as Lyme patients. Are we seronegative? Or, are we inundated with mutant bacteriophages of biological warfare agents? By the way, those in the “ale" order survive only as endosymbionts of other cells. The approved order of Spirochaetales (Treponema and Borrelia Burgdorferi) wasn’t completed until 1980. The earliest “ale” order (Pasteurellales) is dated back to Switzerland in 1919. The latest “ale” order was named in the early 2000’s.
In order to properly screen for the tick-borne diseases, you will need to develop a test that detects the diverse morphological properties of the endosymbionts found within the many "ale" Orders- Pasteurellales, Mycoplasmales, Rickettsiales, Brachyspirales, Spirochetales... These are mutants that can transform themselves in order to evade immune detection. They carry mutant bacteriophages that encode their genetic information into human cells, causing many autoimmune deficiency diseases. The Orders of these endosymbiotic organisms were first recorded in 1919 (Pasteurellales). Is it coincidental that Pasteur was one of the first mad scientists in Switzerland? Could this be the original Swiss Agent that Willy spoke of working with in Switzerland? The last Order of "ales" was created and approved in the early 2000s. The Rickettsiales Order was created in 1939, right around the time Willy was knee deep in the scientific studies here in the US. Treponema (Syphilis) and Borrelia (Borrelia Burgorferi) are the only "spirochetes" in the Order of Spirochaetales. Point blank-any organism found in the “ales” Orders are genetically modified. The time to deal with the truth regarding the creation of mutants is now. Enough people are suffering and enough people have died!”
I want the TBDWG to respond as to when they plan on addressing the real issue of cross-kingdom origin of Lyme Disease with Congress? I want the Mimiviruses addressed so that people can finally be treated correctly! Here’s where my research has led me and why Durland Fish’s statement is soooo true.
A huge reclassification of bacteria has taken place. The "ale" order started in the late 1930 and slowly increased until the 1980s and 2000s when the classification of the "ale" order exploded! The "ale" order is made up of "bacteria" known to carry viruses. These viruses are called "Mimviruses". They are mosiac structures whose name means "mimicing microbes". In other words, the "like" organisms. The Rickettsia-like, mycoplasma-like, spirochete-like...these organisms can contain the DNA and RNA of many forms of bacteria and viruses. Mimiviruses are nearly the same size as bacteria (bacteria-like) and are known to have a symbiotic relationship with smaller viruses. Borrelia Burgdorferi is a large mimivirus that contains DNA and RNA from multiple bacteria- such as Mycoplasma, Rickettsia, Clostridium perfigen, Helicobacter pylori. This brings me to my next point- Bands 31kD and 34kD are from budding yeast organism, and allthough Mycoplasma is associated with yeast, it doesn't always test for the bands. However, Helicobacter pylori does and it's a budding yeast organism. To secure the link between H.pylori and Borrelia Burgdorferi I looked into the phylogenetic tree of Mimviruses...and guess what? Borrelia Burgdorferi is in fact found on both DNA and RNA Mimvirus phylogentic trees. To top it off, there's direct lineage to the mimiviruses of Helicobacter pylori, Clostridium perfrigen, Rickettsia, Mycoplasma.....Bingo! http://www.giantvirus.org/mimitrees/
The Mayday Project
I'm a Lyme sufferer. My 15 year old daughter suffers as well. We need the focus to be on solutions, real solutions based on current science. Small focus on vaccine as it is not trusted due to history and those whose pockets get filled. Are we starting to acknowledge lyme because of the vaccine launch?
Please do not forget the millions that are suffering already and losing their lives every week. The attention needs to be in treatment and prevention. I lose someone with lyme every week. Why isn't this problem being declared an emergency? It makes no sense that Zika got more attention than this. Where's the funding?
Medical doctors need to be forced to be educated in current lyme research. The medical field needs to be corrected right away before another person commits suicide because the doctors aren't helping and treating people like hypochondriacs. Their ignorance and arrogance is obvious and it needs to be addressed by them being forced to open their eyes and not think they know everything based off of their small section about Lyme disease in medical school. Please address this. Doctors are claiming nonsense.
I go on TV all the time trying to inform and protect the public since the government continuously fails to address this.
My name is Tony Galbo. I want to thank Dr. Allen Richards for asking me to share my Daughter Gabriella Galbo’s story and timeline.
Gabriella Giada Galbo was born July 28th, 2006. She was our third and youngest child. Gabby was such a beautiful soul, she knew when to be serious and could make you pop a stitch laughing. She was well beyond her age of five years old. She was the most selfless person I’ve met. At 3 years old her Uncle had put together a doll house she received on Christmas, after a few minutes of Gabby playing with the dollhouse she stops and goes to tell her Uncle Thanks for putting it together. That’s the kind of person our Gabby was. We love and miss her so much.
On Tuesday May 1st, 2012 Gabby woke up with a fever and complaints of her chest hurting. My wife took her to the pediatrician’s office. Gabby was tested for strep which was negative, and she was sent home. We controlled her persistent fever with ibuprofen. On Wednesday May 2nd Gabby was feeling lousy when her fever would spike and playing when it was normal. Later that night at 11:00 p.m. when I got home from work we checked on her, and she was burning up with a fever of 105 and had broken out in a spotted rash all over her body. We took her to our local E.R. The Doctor said she had tonsillitis and gave her 2 shots of Rocephin and we were discharged. My wife called her pediatrician roughly 8 hours later Thursday May 3rd and took Gabby to see her. The pediatrician thought Gabby had atypical coxsackie virus, said her fever would stay high for five days and by Sat/Sun it should subside. We continued to control her fever with ibuprofen. On Saturday May 5th my wife called me at work at 9:00 p.m. and said Gabby’s fever spiked to 106.1. We raced her to the E.R. at a level one trauma hospital in Urbana, Illinois where she was seen by the pediatric intensivist. He checked her over and said he could give her I.V. fluids if we wanted. There was no urgency even though she hadn’t urinated in 23 hours at this point. We said yes to the I.V. and labs were ordered. At around 3:30 a.m. another E.R. doctor came in and said Gabby could go home. I asked him if her blood work was ok three times, and each time he said that it was fine. My wife and my sister continued to ask the Dr. questions about why her fever would be so high and he stated a fever is the way a body fight an infection. He said, “A fever can run as high 106,107,108 even 110.” We didn’t buy what he was saying and let that go in one ear and out the other. We were discharged and arrived home, Sunday May 6th at 5:30 a.m. Later that day Gabby’s fever was between 99-100, the lowest it had been in six days. We thought that the virus had finally run its course.
Monday, May 7th Gabby was still not herself, so my wife called the pediatrician and left a message, and mentioned her E.R. visit on Sat/Sun. Three hours later the nurse called back and said we could bring her in that day or the next. I asked if the pediatrician had seen the blood work results from her E.R. visit. The nurse told me the pediatrician was reading them over her shoulder. I then heard the pediatrician say, “OH MY GOD IT’S A MESS CALL 911!” Gabby’s blood work was abnormal, and she needed to go to the E.R. immediately. I was told the pediatrician was putting admitting orders in the hospital computer.
We immediately got to the hospital. I grabbed the E.R. doctor, explained that she had been sent home with horrible labs and that admitting orders were in the computer. The E.R. doctor disappeared, and we never saw him again. A child life specialist came in and asked if we needed anything and I said WE NEED A DOCTOR! She came back with a pediatric hospitalist and we were moved to the pediatric floor. At 11:00 p.m. Gabby’s blood pressure plummeted, and I noticed swelling around her eyes, hands and feet. The new pediatric intensivist in charge said Gabby was third spacing, and being moved to SICU. I asked him about transferring to Peoria children’s hospital. He said he didn’t feel they would anything different for her at that time, but we could have a transfer anytime we wanted. He stated she may get sicker before she got better, but didn’t elaborate on specifics. She received an internal line and blood pressure medications.
Tuesday May 7th, they did a lumbar puncture on her, and I refused to leave Gabby, so they let me stay. That’s where I heard the doctor tell the nurse in a whisper “we think she’s Septic.” We confronted them, and they explained they were testing and treating Gabby. They asked questions about animals and wooded areas and mentioned Rocky Mountain spotted fever, but didn’t ask or elaborate to my wife about tick borne diseases. Three hours later I noticed Gabby’s abdomen was swollen and her breathing was rapid. I alerted the doctor who said, “OH DEAR, her liver is palpable.” I didn’t know what that meant, and said I wanted Gabby transferred to Peoria NOW! We were told she wasn’t stable enough now, and they had to intubate her first. We had to leave the room and Gabby was crying, saying “DAD DON’T GO, I WANT MY MOMMY!” After an hour and a half, they wheeled Gabby out to be prepped for life flight that was arriving. Gabby’s face, neck, and tongue were swollen. I asked why she looked like that. They said her appearance was normal, but something didn’t seem right. When we got her to children’s hospital in Peoria the medical team acted like the president had landed. They were all scrambling to tend to Gabby. In the first two hours we saw multiple pediatric specialists. They were treating for everything. They thought Gabby had Rocky Mountain Spotted Fever from a possible tick bite. Doxycycline was given in the first two hours of arriving. In the coming hours we would take small steps forward and then ten back. Eventually there were no more steps forward, and Gabby died Friday May 11th at 10:58 a.m. While we waited for a transfer to the autopsy I was blowing on her hands and feet trying to keep her warm. I was crying, angry and started to hit the counter in the room, yelling that there has got to be “Gabby’s Law.”
Gabby was here on earth for 5 years, 9 months, and 2 weeks. Why and how did our daughter die? After her passing we combed through her medical records and saw that her pediatrician on day 3 after sending my wife home with coxsackie virus diagnosis dictated in her charts she didn’t think Gabby had RMSF. She did not discuss this with my wife nor take a possible tick exposure history. On Day 7 a critical care Dr. thought of Ehrlichiosis but again did not discuss it or take a history of tick exposure. On day 8 another Dr. thought of TBD’s RMSF and asked of possible tick exposure but showed no urgency or explain how dangerous RMSF was. Her E.R. labs from May 5th. At the top they said “abnormal.” Her blood pressure was 82/39. Her platelets were at 80,000 and the lowest it should be is 175,000. She had 23% bandemia present and the most you should have is 6%. Her labs had 18 abnormal flags. The discharging E.R. doctor stated, “her labs were unremarkable”. Gabby also had 3 out of 4 signs of SIRS (systemic inflammatory response syndrome) that night. If you show two signs of SIRS, you should think sepsis. Gabby presented for sepsis with her labs, symptoms and vitals. Her rash, bandemia, low bp, fever, pain, lethargy, confusion, no urine output, low platelets, high heart rate, and abdominal pain called for sepsis treatment protocols.
Monday May 7th when admitted her labs were even worse they were off the charts, and still no sepsis protocols. The first antibiotics were just before midnight on May 8th. Treatment for sepsis should have started 50 hours earlier. Every hour she went untreated took 8% off her survival rate. Negligence and delay in treatment cost Gabby her life.
When TBDs are brought up in the medical community they are dismissed and deemed RARE. They are not current with any of the protocols.
- The first action is tick season needs to be removed from the literature. Mrs. Patricia Smith brought this up and I completely agree. There are reports across the country of ticks all year long. Yes, tick populations are less in the winter months, but DO NOT DISMISS a possible TBD diagnosis because of the month of the year. We found out that the reason our pediatrician dismissed RMSF was because it wasn’t the summer months, in addition to her admitting that she did not know her facts on RMSF in 2012, nor did she stop to look up the facts or take a proper history etc.
- Clinicians need to know the protocols of when you think of a TBD you treat immediately then test! Time is very critical you do not use a wait and see approach. Not only does it need to be pushed in medical schools, but to the current clinicians in the medical field. Our pediatrician on day 3 did not treat, take an appropriate history, nor test Gabby. A critical care Dr. did not treat Gabby on day 7 despite us confirming that she had been near the woods and animals. On day 8 Pediatric intensivist did not treat her either. We understand that after five days of not starting doxycycline your chance of survival goes down. You still have to try and give supportive measures to the patient for the best possible outcome. That’s what hurts the worst there were so many opportunities to save Gabby and they were wasted, Days 3, 5,7,8.
- Education for clinicians of ticks and TBD’s. Clinicians need to be able to identify the ticks that are in their area, and the different diseases that each one carries. They also need to know about coinfections, and that ticks can carry more than one disease. Every tick is NOT a deer tick and every tick is not just carrying Lyme disease, or Lyme at all. Different TBDs present with different symptoms, rashes, and some are only responsive to particular antibiotics! On March 31st, 2013 we found a tick on my daughter Nina. We brought her to the ER and asked for it to be removed. We told the Dr. we were concerned about RMSF and he told us that it was rare and not in Illinois. Of course, I became very irate and told him our youngest died of RMSF 11 months ago. I told him I want the tick tested for possible RMSF and I wanted Nina to be treated with doxycycline since it was a dog tick. He refused so a nurse that knew me pulled me aside and gave me doxycycline and assured me that she would send it to be tested. When we left they gave us literature on Deer ticks and Lyme disease, but included NO literature on American dog ticks and RMSF…. the bacteria which American dog ticks primarily carry. How can a patient know to look for symptoms of RMSF if they have been sent home with literature on what to watch for with Lyme?? Both Lyme and RMSF literature should have been sent home. Seven days later the tick we had tested was positive for RMSF. So if we didn’t have our Nightmare in 2012 we would have had it in 2013. We feel Gabby saved her older sister.
- When a suspected or confirmed case of TBDs it is the duty of the county, state health departments to alert the public, yet doctors are NOT properly reporting suspected or confirmed cases which skew the numbers and urgency on whether or not these TBDs are in the area! When Gabby’s RMSF was confirmed by a second autopsy by Dr. Louis Dehner at Barnes Hospital in St. Louis and the CDC five months later we went to the public health department and see if they were going to do anything. They did nothing to alert the community. After Nina’s tick was confirmed in 2013, and we heard that the local schools were taking students out to an area wooded park where ticks may be present, we demanded the public health department act and put out proper warning. Their response was to send home a beware of ticks in the area flyer to each student at school, and they also posted the flyer at our local hospital/ER…..a poster that is no longer even out at our local doctors’ office. It has been removed. These flyers/warnings should be posted in every exam room and waiting area. What do people do while they are waiting? They start looking around at things that are posted, they read, they can get informed and educated. A doctor may not even ask a patient about possible TBD during more probable times of the year, but a patient who is given the opportunity to read something posted may be tipped off to the idea and will be able to advocate for themselves etc! Help the patient help themselves for God’s sake! The public health departments throughout the United States differ in taking their responsibilities seriously, and there must be a better standard among these departments. As soon as a confirmed TBD has resulted, the public and the local clinicians need to be notified and educated. The wife of a gentlemen that died in 2006 contacted us in 2013. She told us her husband died of RMSF he is buried 30 feet from my daughter. The public health department knew this and did not alert the public in 2006. In our small town of 6,000 there has been 3 deaths and five confirmed treated cases of RMSF. I have no idea if all of these cases were even reported to our public health. The CDC wants numbers, and if the numbers aren’t great enough there will be no attention…..but tell me how we are going to know the real number if clinicians are NOT reporting both confirmed/suspected cases of TBDs to their public health who can then report to state health? TBDs are reportable infectious diseases!
- Doctors need to be taught that ticks can be sent off for testing, and that anyone who is seen who has an attached tick, or who brings in a tick with them in a container….that tick should be tested while the patient is preventatively treated. If the tick comes back negative for TBDs, then a decision can be made to whether to stop the course of antibiotics. I recommend a mandatory refresher course for all medical professionals every spring which refreshes them on the ticks in their area, the TBDs they carry, their symptoms, and protocols for testing/treating. With our climate changing, and animals migrating into areas they once weren’t, and these animals bringing with them new or increased numbers of TBDs, the medical professionals and health departments (local and state) have got to wake up on this issue.
- Tick attachment needs to be addressed within the literature. Literature states that some ticks need to be attached for 24 plus hours for bacteria to be transmitted, and this is inaccurate! Studies have shown that ticks can transmit bacteria in as little as ten minutes of being attached, and I have talked to several parents who also lost children to RMSF as well as Ehrlichiosis who stated that their child’s tick was only attached for a couple of hours at most, and the ticks were not engorged when they removed them.
- The issue of Doxycycline. Clinicians must be informed that Doxycycline is safe for ALL ages in the treatment of TBDs, and that it is the only effective treatment for RMSF. The issue of tooth staining should not be an issue when the alternative is death and being buried with white teeth….the CDC has been fighting with the FDA to change the recommendation, and now that the recommendation has been changed, better efforts to alert the medical world need to be in place. If a doctor is considering RMSF or other TBDs…they better be current on the protocols/medications to treat! If you were told your loved one’s teeth might become stained (which is purely cosmetic), Doxy posing no other harm…which would you choose. I would take my child with gray teeth, and just to add….unless you are prescribing multi course rounds of Doxy….staining isn’t even a risk. It was horrific to hear during depositions in my child’s case ….the issue of tooth staining, because they considered RMSF, and they should have known their facts or gone to check the facts/protocols which would have told them Doxy is safe, treat asap, but they did not!
- The type and order in which symptoms appear need to be addressed so that clinicians are NOT just going off of what the literature states. Fever is NOT always the first symptom in many, nor does the placement of rash always follow the literature. Not all persons have all of the symptoms, and in talking to other families I have obtained detailed timelines of their illness in which rash for RMSF for example has started on the neck of one child, on the hands and feet of another, while our child broke out immediately ALL OVER her body, giving no indication of where it started first if at all. Many stories include subtle symptoms before a fever ever appeared, including development of headache (with no other initial symptoms), so the cookie cutter literature needs to be heavily revised.
In conclusion, sitting on the CDMRP TBD panel and hearing/seeing research about transmission times being inaccurate, tick season being inaccurate, and geographic locations changing/growing, if clinicians do NOT know the current literature and protocols for identifying/treating this ever growing and dangerous epidemic and needless deaths will continue. After doing research, talking with experts ,and talking with other afflicted families who are suffering needless losses, the standard of care on TBDs and the seriousness of them must be brought to a whole new level locally/nationally.
On behalf of my daughter Gabriella Giada Galbo.
Transparency in the Tick-Borne Disease Working Group
My name is Enid Haller; I am a recent member of the Access to Care Services and Support to Patients Subcommittee of the Tick-Borne Disease Working Group. I request this statement to be added to the public record
- What is Transparency (in general)?
- How does Transparency apply in Lyme Disease?
- How does Transparency relate to the mission and goals of the Working Group?
People want and need to feel that the Lyme Leadership -- among physicians, medical researchers, government research-funders, government policy-setters, and industry lobbying groups -- has their best, human interests at heart and in action from both the population and the individual perspectives.
1) What is Transparency?
Transparency in General
Open discourse; free flow of information; plain language; accomodation to diversity of opinion; authoritative standards practice; rigorous review and testing of ideas; collaboration
Transparency in Medicine
Respect for the Scientific Method; openness to new information and innovative ideas; honest, self-effacing peer-review; open sharing of data; honesty in formation of diagnostic criteria; honesty in formation of treatment criteria; patient-centered action; truthful and complete assessment of the biological threats; accommodation to biological complexity and regional differentiation of the biological challenge.
Transparency in Government
Open deliberation; reconciliation; even playing field and shrewd distribution of funding; expert consultation; fairness.
Signs of an absence of Transparency
Mono-thinking; circular reasoning, bad-faith argument and ad hominem attack; lying; obfuscation; defensiveness; stifling of new ideas (innovation); gaslighting; denial; threatening legalistic language in treatment guidelines that scares and limits the action physicians; hypocritical licensing enforcement; inconsistent standards of medicine prescription; corporate favoritism; competition, careerism and corruption.
2) How does Transparency apply in Lyme Disease?
Lyme Leadership needs to earn back public trust. One of the factors in the loss of trust throughout the history of Lyme Disease, particularly since “Dearborn” in 1994, is the pro-pharmaceutical bias in the Disease Definition, in the Diagnostic Standard, and in the Treatment Protocol Standard that was not focused on metrics of success related to personal wellness.
3) How does Transparency relate to mission and goals of the Working Group?
The Tick-Borne Disease Working Group and subcommittees need to adjust toward a more open and balanced approach than is currently in evidence. The Working Group and subcommittees presently suffer from a deficit of Transparency in which an anti-patient bias infects membership structure and contradicts the Working Group’s stated mission.
According to her “UPDATES as Anti-patient Bias Increases in Tick-Borne Disease Working Group and its Subcommittees,” Jenna Luche-Thayer on February 11, 2018 remarks:
As noted, according to the HHS website on the Tick-Borne Working Group (“TBDWG”), “the TBDWG is committed to openness and transparency in its work, and to providing impartial, evidence-based recommendations to the HHS Secretary and Congress. This commitment aligns with requirements in the Federal Advisory Committee Act (FACA) and the Sunshine Act. These requirements stipulate that: a balance in points of views be represented by the committee and committee recommendations be objective and accessible to the public.” However, the selection of the 53 members for the TBDWG Subcommittees demonstrates that these requirements are not being met.
The article outlines the areas and ways in which the Working Group’s configuration supports and accelerates the anti-patient bias, including the voting and subcommittee members’ alignment with the IDSA’s historical violation of patient-priorities; alignment with the CDC’s and NIH’s historical denial of chronic manifestations of Lyme Disease and co-infections; alignment with support for an inadequate diagnostic testing standard (ignoring multiple strains of Borrelia and ignoring common co-infections and regional differences in remedial diagnostic and treatment standards); alignment with limitations of speech and thought imposed upon government employees; alignment with speech and thought limitations imposed upon recipients of federal grant funding; alignment with the CDC’s, NIH’s and IDSA’s unrealistic disease definition; and alignment to reinforce the IDSA bias that persons suffering from persistent Lyme symptoms do not have biological illness but are psychosomatic hypochondriacs who will benefit from counseling and palliative care; among other analytical and critical points.
In conclusion, if the history of Lyme Disease and our medical and standards-making approach to defining and solving the problem has until today been closed, insufficient, and lacking in innovation then this is due to an absence of Transparency.
The Working Group needs to host a Diversity of Opinion. The positions and views of different Lyme-Advocacy groups and individual advocates need to be captured, registered and included in the WG and subcommittee processes. We need to make more room and add processes to capture this wider diversity and ensure that the Working Group’s output represents a strong leadership consensus.
Transparency will improve communication with the wide community of Lyme patients as well as increase the credibility of the Working Group and its product.
Transparency also implies publishing a complete and honest History of Lyme Disease – not starting in 1977 but reaching back to the origins of spirochetes, syphilis and vectors related to Lyme Disease, including ALL STRAINS of Borrelia Burgdorferi and co-infections.
Among the measures I would seek to implement, I would:
1) Interview the Co-Chairs of the Working Group and collect the subcommittees' notes and their reports and post them on HHS website as a way to evidence the Working Group’s value in openness.
2) Publish notices about meetings in Washington, making sure that the meeting format includes open Question & Answer periods and that these are transcribed and published on the website; same goes for the call-in meetings.
3) Encourage that the members of the Working Group disclose conflicts of interest.
4) Publish historical record of all spending by HHS and the DoD on Lyme Disease research and all activities.
5) Open free discourse across and within the Working Group and subcommittees; make them free to talk to each other.
6) Release HHS and DOD documents for all the subcommittees to review as required by the legal charter of the Working Group.
7) Openly publish ALL PUBLIC COMMENTS submitted by the public to the Working Group and subcommittees.
There is a great patriotic tradition here of citizens acting as watch-dogs over the government process; I want to be the head watch-dog so that people outside the process can feel secure that their concerns are being respected.
A friend recently sent this quote to me: “Sometimes it is better to be kind than to be right. We do not need an intelligent mind that speaks but a patient heart that listens.” The work of the WG needs to capture all the voices
Lyme Center of Martha’s Vineyard
Martha’s Vineyard Lyme Support Group
Shared Medical Decision Making and the Two Standards of Care in Lyme Disease
HHS TBDWG June 18, 2018 comments submitted on behalf of LymeDisease.org by Lorraine Johnson, CEO
There is considerable uncertainty in the diagnosis and treatment of Lyme disease. Most patients know that they should be told the risks and benefits of different diagnostic and treatment approaches of Lyme disease. They also know that they should be told the risks and benefits of different treatment options and be able to make the determination of the best approach in collaboration with their physician. This process is called shared medical decision making and is most often used when science is uncertain, there is no single “best” approach, and trade-offs exist between their benefits and risks and their associated quality of life consequences. Shared decision making is increasingly being promoted by different government agencies and rigorous evidence assessment protocols. LymeDisease.org believes that the time has come for the government, medical specialty groups, and physicians and to promote shared decision making with Lyme disease patients.
In healthcare, the primary goal is to improve healthcare outcomes that are important to patients. In 2001, the National Academy of Medicine (previously the Institute of Medicine) (NAM) defined patient-centered care as care that is respectful of and responsive to individual patient preferences, needs, and values and that ensures patient values guide all clinical decisions.(1) Patient-centered care focuses on achieving treatment outcomes that patients value, including the restoration of health, prevention of health deterioration and the provision of treatments that have the potential to improve quality of life.(2) To facilitate the development of treatment plans addressing the unique circumstances and values of individual patients, patient-centered care encourages shared medical decision-making.
Shared medical decision-making is an integral part of evidence-based medicine. Evidence-based medicine is the integration of best research evidence with clinical expertise and patient values.(3) Evidence assessment protocols recommended by the NAM, such as Grading of Recommendations Assessment, Development, and Evaluation (GRADE) value the evaluation of outcomes of alternative management strategies and the distribution of values and preferences in patients considering those alternatives as well as shared decision making in encounters between physicians and patients.(4)(5)
The importance of shared medical decision making when different treatment options exist is also being embraced by government agencies. For example, the Patient Centered Outcomes Research Institute,(6) the Food and Drug Administration,(7) the National Quality Forum, and the Agency for Health Research and Quality(8) have each embraced shared-medical decision making as a component of patient centered care.(9) It is also one of the aims of the U.S. Department of Health Services Healthy People 2020 program.(10)
Most recently, the Centers for Medicare and Medicaid Services has begun requiring shared medical decision making for reimbursement of certain procedures.(11) As the CMS explains: “Shared decision making can ensure that treatment decisions, for the many medical conditions that do not have one clearly superior course of treatment, better align with beneficiaries’ preferences and values.”(12) Under shared decision making, clinicians are viewed as the experts in the evidence and patients are the experts in what matters most to them.(13)
Shared decision making is ideal when there is medical uncertainty and treatment choices involve trade-offs between the risks and benefits of different treatment approaches. For example, breast cancer and prostate cancer patients have tough choices to make. No one knows whether it is better to do watchful waiting, surgery, or hormone therapy for prostate cancer. But we do know that the patient is the one who has to live with the decision and that the medical decision made may significantly affect the course of their life. Often this occurs when there is more than one standard of care for the condition.
Medically recognized standards of care are those accepted by medical experts as appropriate treatments for a disease or condition and commonly used by healthcare professionals. Medical recognition of standards of care is typically represented by publication in a peer-reviewed journal or some form of recognition by a professional medical society.(14) According to the National Guidelines Clearinghouse conflicting guidelines are not uncommon. It has posted conflicting guidelines for over 25 medical conditions and notes that these arise most often when the evidence base for a disease is weak and the guidelines panels hold different values.(15)
There have only been only four high level GRADE assessments of the evidence for treating persistent Lyme disease: one by the International Lyme and Associated Diseases Society (ILADS)(16), one by the Hayes and Mead(17) of the Centers for Disease Control, one by Cochrane(18), and one by England’s National Institute for Health and Care Excellence (NICE)(19). All four have acknowledged that the evidence-base for making treatment decisions in Lyme disease is weak.
The National Institute of Health has only funded three small clinical trials for persistent Lyme disease. Sample sizes in these studies were extremely small, ranging from 37 to 129. Nevertheless, two of the three studies demonstrated that retreatment improved some patients’ measures, such as fatigue and pain.(20)
In addition, current diagnostic testing for Lyme disease is of poor quality and is unable to detect active infection or cure. Further uncertainty results from the high rate of treatment failure for all stages of Lyme. Some studies of early Lyme disease suggest the treatment failure rate for early Lyme disease may be as high as 36%.(21) In late Lyme disease, treatment failure rates may exceed 50%.(22) Because of the lack of guidance from high quality evidence and the poor quality of diagnostic testing, doctors and patients are uncertain about the best way to diagnose and treat the disease.
This uncertainty is compounded by the fact that persistent Lyme disease can be long lasting and significantly impair patient quality of life. It also may be costly to patients, employers, healthcare systems, and society. In a study of more than 5,000 patients with persistent Lyme disease, half report that they have been ill for more than 10 years.(23) These patients suffer a worse quality of life than those with most other chronic illnesses, including congestive heart failure, diabetes, multiple sclerosis and arthritis. Over 43% report that they had to stop working, and 25% report that they have been on disability at some point in their illness. They are five times more likely to visit healthcare providers and twice as likely to be seen in emergency rooms compared to the general population. The cost of this increased healthcare utilization continues until patients are restored to health.
The diagnostic and treatment uncertainty combined with the significant quality of life impairment suffered by patients who remain ill, has given rise to two medically recognized standards of care that are used by healthcare professionals for diagnosis and treatment. Both standards are reflected in peer-reviewed published guidelines—one by the ILADS(24) and the other by the Infectious Diseases Society of America (IDSA).(25) The ILADS guidelines are more current and adhere to the rigorous GRADE evidence assessment standards recommended by the Institute of Medicine.
The main difference between the IDSA and ILADS guidelines is that in the face of scientific uncertainty, the ILADS guidelines defer to clinical judgment and shared medical decision-making. Those of the IDSA severely restrict the use of clinical judgment and strongly recommend against treatment, regardless of the disease severity, complexity, prior treatment response, or functional impairment of the patient.
The IDSA leaves patients without treatment options when short term therapy fails, as it does in far too many cases. This is why over 95% of patients with persistent Lyme disease are treated by either an ILADS-trained physician, or a family practitioner or internist.(26) Only 3% report being treated by an infectious disease specialist. Similarly, a recent CDC HealthStyles national survey found that only 39% of patients with Lyme disease were treated in accordance with blanket short term recommendations in the IDSA guidelines. The majority were treated for longer periods.(27)
For diseases that lack the research base essential for evidence-based decisions, shared medical decision making with patients should be encouraged as part of good practice. This involves a discussion between the patient and the physician that presents risks and benefits of alternative treatments in a balanced manner, identifies the individual patient’s preferences and values, and engages patients in decision making among treatment trade-offs.(28) Together, they choose a course of action.
Because two medically recognized standards of care exist for Lyme disease, LymeDisease.org, which represents thousands of patients nationally, believes that:
- Government agencies should provide unbiased public information regarding both standards of care and treatment approaches;
- Physicians should provide information regarding the risks and benefits of all available treatment options and decide with their patients which actions to take; and
- Insurance reimbursement should be available for treatment by either standard of care.
LymeDisease.org has created a shared medical decision-making form that is available for download for physicians and patients to use specifying the different treatment approaches and their associated risks and benefits.(29) This shared decision-making form was also included in the report of the Access to Care subcommittee of the TBDWG.
- Institute of Medicine (Committee on Quality of Health Care in America). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001.
- Cameron DJ, Johnson LB, Maloney EL. Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease. Expert Review Anti-Infective Therapy. 2014 Sep;12(9):1103-35. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25077519.
- Sackett D et al. Evidence-Based Medicine: How to Practice and Teach EBM (2000).
- Guyatt G, Eikelboom JW, Akl EA, Crowther M, Gutterman D, Kahn SR, et al. A guide to GRADE guidelines for the readers of JTH. J Thromb Haemost. 2013 Aug;11(8):1603-8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23773710.
- Schünemann H, Brożek J, Guyatt G, Oxman A. Handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach. Available from: http://gdt.guidelinedevelopment.org/app/handbook/handbook.html
- The Patient Centered Outcomes Research Institute, Topic Spotlight, Shared Decision Making https://www.pcori.org/research-results/topics/shared-decision-making
- Food and Drug Administration, A Framework for Benefit Risk Counseling to Patients https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM577883.pdf
- Agency for Health and Research Quality, The SHARE Approach, Putting Shared Decisionmaking into Practice. https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/education/curriculum-tools/shareddecisionmaking/tools/tool-8/share-tool8.pdf
- Patient Centered Outcomes Research Institute. PCORI Announces New Initiative to Support Shared Decision Making. July 18, 2017. Available from: https://www.pcori.org/news-release/pcori-announces-new-initiative-support-shared-decision-making.
- Office of Disease Prevention and Health Promotion, Health Communication and Health Information Technology. https://www.healthypeople.gov/2020/topics-objectives/topic/health-communication-and-health-information-technology.
- Merchant FM, Dickert NW, Howard DH. Mandatory Shared Decision Making by the Centers for Medicare & Medicaid Services for Cardiovascular Procedures and Other Tests. JAMA. Published online June 04, 2018. doi:10.1001/jama.2018.6617.
- Centers for Medicare & Medicaid Services (Department of Health and Human Services). Beneficiary Engagement and Incentives Models: General Information. Available from: https://innovation.cms.gov/initiatives/Beneficiary-Engagement/ .
- Spatz ES, Krumholz HM, Moulton BW. Prime time for shared decision making. Jama. 2017;317(13):1309-10. Available from: http://dx.doi.org/10.1001/jama.2017.0616.
- The Office for Human Research Protections, Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-disclosing-risk-in-standards-of-care/index.html.
- Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011. Available from: http://books.nap.edu/openbook.php?record_id=13058.
- Cameron DJ, Johnson LB, Maloney EL. Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease. Expert Review Anti-Infective Therapy. 2014 Sep;12(9):1103-35. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25077519.
- Hayes, E., & Mead, P. (2004). Lyme disease. Clin Evid (12), 1115-1124.
- Cadavid, D., Auwaerter, P. G., Rumbaugh, J., & Gelderblom, H. (2016). Antibiotics for the neurological complications of Lyme disease. Cochrane Database Syst Rev, 12, CD006978. doi:10.1002/14651858.CD006978.pub2.
- National Institute for Health and Care Excellence. Lyme disease: NICE Guidelines. Available from https://www.nice.org.uk/guidance/ng95/evidence
- Fallon BA, Petkova E, Keilp J, Britton C. A reappraisal of the U.S. clinical trials of Post-Treatment Lyme Disease Syndrome. Open Neurology Journal. 2012;6(Supp. 1-M2):79-87. Available from: http://benthamscience.com/open/toneuj/articles/V006/SI0078TONEUJ/79TONEUJ.pdf.
- Aucott JN, Rebman AW, Crowder LA, Kortte KB. Post-treatment Lyme disease syndrome symptomatology and the impact on life functioning: is there something here? Qual Life Res. 2013 Feb;22(1):75-84.
- Johnson L, Stricker RB. Treatment of Lyme disease: a medicolegal assessment. Expert review of anti-infective therapy. 2004 Aug;2(4):533-57.
- Johnson L, Wilcox S, Mankoff J, Stricker RB. Severity of chronic Lyme disease compared to other chronic conditions: a quality of life survey PeerJ. 2014; 2: Available from: http://dx.doi.org/10.7717/peerj.322.
- Cameron DJ, Johnson LB, Maloney EL. Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease. Expert Review Anti-Infective Therapy. 2014 Sep;12(9):1103-35.
- Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, Klempner MS, et al. The clinical assessment, treatment, and prevention of lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006 Nov 1;43(9):1089-134.
- Johnson L, Aylward A, Stricker RB. Healthcare access and burden of care for patients with Lyme disease: a large United States survey. Health Policy. 2011 Sep;102(1):64-71. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21676482.
- Hook S, Nelson C, Mead P. Self-reported Lyme disease diagnosis, treatment, and recovery: Results from 2009, 2011, & 2012 Health Styles nationwide surveys. Presented at The 13th International Conference on Lyme Borreliosis and other Tick Borne Diseases, Boston, MA Aug 19, 2013. Available from: http://bit.ly/1B2WrfZ.
- Merchant FM, Dickert NW, Howard DH. Mandatory Shared Decision Making by the Centers for Medicare & Medicaid Services for Cardiovascular Procedures and Other Tests. JAMA. Published online June 04, 2018. doi:10.1001/jama.2018.6617.
- LymeDisease.org, https://www.lymedisease.org/wp-content/uploads/2018/05/Informed-consent-for-Lyme-treatment.pdf
Your TBDWG is riddled with disgraceful problems. We are all aware of the many conflicts of interest. We are aware that you entered into this with a clear agenda of vaccine development. We know all about the fact that the government is in bed with Pat Smith and that deals have been made to fund LDA/LDO in return for Pat Smith deceiving the Lyme community and selling us out by going along with the vaccine. Pat Smith and her affiliates DO NOT represent the greater Lyme community. We trust her about as much as we trust you. We know that she has been holding government secrets to the detriment of the Lyme community for decades. She is evil in our eyes.
We are well aware of all the stakeholders at the table who have patents and make money off of the misery and status quo of Lyme patients. You should all be ashamed of yourself.
It has been well broadcast through social media, and hopefully will soon be in the mainstream media, that secret meetings have taken place, secret email addresses to hide things from FOIA requests have been ordered, Lyme advocates have been bullied, silenced or fired from the Working group. It is well known that Kristen Honey has an agenda all her own. She doesn't even do the bidding for you. She's manipulating things to her own benefit so she can sell her nanoparticles on the market. Her personal history is disturbing, and she shouldn't even be there because she IS NOT legally a Federal Officer.
We've heard that minority opinions have been omitted from some reports. We've heard that legitimate research was not allowed to be entered in the subcommittee meeting because it did not match your agenda and would price you wrong about many aspects of Lyme. We've heard that reports have been rewritten by Honey because the real report did not suit the agenda laid out for the TBDWG.
Dr. Smith is downright hostile and clearly anti patient.
The fact that you all actually voted against patients being allowed to see the full results of their Western Blot test goes against our basic rights. Who are you to deny that to Lyme patients?
YOU HAVE LOST THE TRUST OF THE LYME COMMUNITY.
THIS IS DEARBORN 2, AND YOU SHOULD BE ASHAMED OF YOURSELVES.
We are not going away. We are not going to stop. While you sit on your thrones, there are millions of people suffering and dying a slow, painful death. Someday, you will be held accountable for the crimes against humanity that you perpetrate. The class action suits have already begun, and more will follow. Antitrust lawsuits will soon have your names on them, too.
Find your humanity and fix this mess, please.
I am an administrator in the Beating Bartonella Facebook group and have been updating the group regularly with your meetings, etc. We are pleased that you are recommending that Bartonella be considered a tickborne infection along with the other ways it is transmitted. We are hoping to see that there is a recommendation for funds to be allocated for continued Bartonella research into treatment and testing. We are also hopeful for a broader push for public education and awareness regarding transmission and symptoms of Bartonella. We also hope for a push for physician and veterinarian knowledge into the various ways that a bartonella infection can manifest besides the typical cat scratch disease as well as how to diagnose and treat it.
Our questions are:
- What is the next step after the release of the group's recommendations in Dec 2018 to Congress?
- Will Congress vote on these guidelines?
- Will they be adopted by the cdc, idsa, acr?
- Upon release of your recommendations, will doctors have to go through mandatory training at that point or how will they be held accountable for these changes in policy and thinking?
- Could you consider our recommendation that insurance companies cover testing from specialty labs for bartonella testing, like galaxy diagnostic's ePCR, due to the lack of sensitivity of commercial labs and thus the high rate of false negatives?
On behalf of the 7,700 members in Beating Bartonella and my 15 year old son who is fighting a bartonella infection....
Thank you for your consideration,
My name is Dorothy Leland, I live in Davis, California, and I am the mother of a daughter who has had Lyme disease and co-infections for 13 years. I’m also vice president of LymeDisease.org, write the blog TOUCHED BY LYME, and co-authored the book “When Your Child Has Lyme Disease: A Parent’s Survival Guide.”
Although there are controversies in Lyme disease and differing viewpoints on this Working Group, I do believe that all sides could agree that early diagnosis and treatment of tick-borne disease is a good thing.
Yet, many factors stand in the way of prompt diagnosis. Here are two of them.
First: the dubious belief that a single dose of the antibiotic doxycycline, given within 72 hours of a known tick bite, will prevent Lyme disease. This is based on exactly ONE study by Nadelman, published in 2001. In it, fewer people developed an EM rash if given a single dose of doxycycline than if given a placebo. Anyone who didn’t develop an EM was presumed not to have Lyme disease—even though many Lyme patients never see a rash. Furthermore, they didn’t look for co-infections, and the observation period was a scant 6 weeks. So, nobody actually knows whether any of these people got sick later, or not.
Despite the glaring weakness of that study, the one-dose doxy recommendation was enshrined in the IDSA’s 2006 Lyme guidelines…and further replicated in the Journal of Emergency Medicine, as recently as 2017. It’s also repeated on the CDC website.
I have heard from many people who were treated with a single dose of doxy and then went on to develop symptoms of Lyme and coinfections. Clearly, this unfortunate recommendation delays appropriate treatment—to the detriment of patients. It should be abolished.
My second point concerns tick attachment times. Many patients report that they went to their doctor after a known tick bite and were denied treatment because they “couldn’t possibly have Lyme disease” because the tick hadn’t been attached at least 24, or 36, or 48, or 72 hours. (Take your pick. We’ve heard them all.)
There is no evidence of a “safe” attachment time. Although the CDC website maintains that it usually takes more than 36 hours for the tick to transmit Lyme, even its own recent publication suggests otherwise.
The March 2018 edition of Ticks and Tickborne Diseases includes an article entitled “Pathogen transmission in relation to duration of attachment by Ixodes scapularis ticks,” by L. Eisen. In it, the author discusses specific circumstances (such as re-attachment of previously partially fed infected ticks) where Lyme might be transmitted in less than 24 hours.
The issue is so much larger than just Lyme, however. Powassan virus can be transmitted in 15 minutes. For many other tick-borne diseases, required transmission time in UNKNOWN.
When people with known tick bites are denied treatment because the tick supposedly was not attached long enough…they often end up desperately sick.
- Eisen L. Pathogen transmission in relation to duration of attachment by Ixodes scapularis ticks. Ticks Tick Borne Dis. 2018.
- Piesman J, Maupin GO, Campos EG, Happ CM. Duration of adult female Ixodes dammini attachment and transmission of Borrelia burgdorferi, with description of a needle aspiration isolation method. J Infect Dis. 1991;163(4):895-897.
- Shih CM, Spielman A. Accelerated transmission of Lyme disease spirochetes by partially fed vector ticks. J Clin Microbiol. 1993;31(11):2878-2881.
History of Lyme Disease Vaccines
by Lonnie Marcum, PT
In 1977, Dr. Allen Steere first described an “epidemic” of arthritis occurring in patients living in the community of Lyme, Connecticut. By 1982, researchers had identified a spirochete in blood samples from those patients and determined it to be the cause of this cluster of illnesses. The bacterium was later named Borrelia burgdorferi after Wilhelm Burgdorfer, the scientist who identified it, and the illness was named Lyme disease, after the community in which it was discovered. (Burgdorfer 1982)
It’s now known that Lyme disease can be caused by different strains and species of Borrelia bacteria, though most commonly by B. burgdorferi in the US and B. afzelii and B. garinii in Europe. (Cutler 2016) However, there are over 300 strains of Borrelia worldwide, with over 100 of those found in the US alone. (Cerer 2016)
Recently, Borrelia spirochetes have been discovered in 5,300-year-old human remains from Europe (Keller 2012) and in fossilized 15-20 million-year-old amber from the Dominican Republic. Thus, Lyme disease is not a new phenomenon. (Poinar 2015)
According to the Centers for Disease Control (CDC), the incidence of reported vector-borne diseases (caused by ticks, mosquitos and fleas) tripled during the period 2004-2016 with 75% of those infections coming from ticks. Lyme disease accounted for 82% of the tick-borne disease reports and is overall one of the top three “nationally notifiable” infectious diseases in the United States. (Rosenberg 2018)
Borrelia are Complex Bacteria
Borrelia burgdorferi is one of the most complex bacteria known to man. Its unique genomic structure contributes greatly to its ability to survive and maintain an extremely difficult life cycle that alternates between warm-blooded animals and cold-blooded ticks. (Brock 1994; Frasier 1997; Porcella 2001)
Because of their genomic complexity, all Borellia have the ability to alter their outer surface proteins when conditions change—a process known as antigenic variation. This complexity allows Borrelia to adapt to a variety of hosts, avoid immune detection, widely disseminate throughout the body, and support chronic or persistent infection. Borrelia has also been shown to survive standard antibiotic therapy in several animal and primate studies. (Hodzic, Barthold 2014; Elsner, Baumgarth 2015; Embers 2017)
Many of the reasons we do not have a vaccine for Lyme disease are the same reasons we do not have a vaccine for other complex bacteria like syphilis and tuberculosis. By design, the genomics of Borrelia, their ability for antigenic variation and the slight variation between each of its species makes it very difficult to design a safe and effective vaccine.
The first vaccine for Lyme disease, “LYMErix,” was FDA-approved in 1998 then removed by the manufacturer in 2002. The vaccine was not without controversy.
- LYMErix did not provide immunity to humans. The LYMErix vaccine was derived from a single outer surface protein of Borrelia burgdorferi known as OspA. The vaccine relied on the tick to feed on the vaccinated human, ingest a human byproduct of the vaccine (OspA antigen), that would then kill the Borrelia spirochete in the midgut of the tick. In order to work, this process needed to take place prior to the tick injecting the live spirochetes into the human—a process that the makers of LYMErix admitted was only partially successful. (Sheller 2013)
- LYMErix required patient/doctor compliance and had limited effectiveness. The vaccine required three doses within a 12 month period in order to obtain enough OspA antigen to be able to kill the Borrelia in the tick. The vaccine was reported to be 50% effective after the second dose and only 73-78% effective after the third dose. There were no studies to show what would happen to a patient if they were bitten by an infected tick during the vaccine series, and there were no studies demonstrating whether the vaccine would provide long-term protection or not. (Smith 2002)
- LYMErix caused auto-immune reactions in some. Just prior to FDA approval of LYMErix, Dr. Allen Steere and others published research describing potential auto-immune responses to OspA in a subset of patients who are born with a genetic defect known as HLA-DR4, which is found in about 30% of the population. (Gross 1998)
- LYMErix caused adverse events that ranged from mild to life-threatening illness, including symptoms of Lyme disease. In the FDA’s 2001 Safety Data Report there were 1,048 reports of injury following the vaccine, including 4 deaths, and 85 serious events. (Ball 2001; Latov 2004; Rose 2001)
- LYMErix caused hyper immune reactions. A subset of the vaccinated population had extreme immune responses to the vaccine, causing them to tests positive for Lyme disease. Using the currently available test, there was no way to determine if the patient had contracted a new case of Lyme, reactivated an subclinical infection, or if they were having an auto-immune reaction to the vaccine. Note: 20-30% of the vaccinated had no protection from Lyme. (Fawcett 2001)
- LYMErix caused severe neurological complications in some patients that may have been related to asymptomatic pre-existing Lyme disease infections and/or HLA-DR defects. (Marks 2011)
- LYMErix resulted in multiple class-action lawsuits. After reports of injury the FDA requested GlaxoSmithKline, the makers of LYMErix, to expedite the reporting of their Phase IV trial, including all adverse events. Shortly after a study was published documenting injury, LYMErix was pulled off the market citing “poor sales.” (Stricker, Johnson 2014)
Present Vaccine Development
- OspA Vaccines. There have been several previous OspA vaccines developed and pulled off the market. The latest OspA vaccine (VLA15) is undergoing Phase 1 clinical trials in Europe. We do not yet know if this OspA vaccine will cause the same adverse reactions as previous. (Comstedt 2017)
- OspC Vaccines. The OspC vaccine that is available for dogs (VANGUARD) is currently being modified for human studies.
- OspA-C Vaccine. Work is being done on a totally new vaccine that combines portions of OspA and OspC with the protein sections removed that are believed to elicit adverse events. It is possible this vaccine will provide a broader protection against multiple species of Borrelia. (Marconi 2017)
Challenges to a human Lyme vaccine
- Public trust—The public must know with certainty that future vaccines are safe.
- Vaccine development is extremely slow and expensive.
- Difficult to design an effective Lyme vaccine with 300+ strains of Borrelia worldwide.
- Previous Lyme vaccine caused injury among a portion of the population with HLA defects.
- The tests for Lyme are unable to distinguish between past or present infection vs. vaccine reactions.
- Previous Lyme vaccine may have reactivated pre-existing infections in some patients.
- Patients living in highly endemic areas are at higher risk for adverse events due to Lyme exposure.
- The Lyme vaccine does nothing to slow the rapid spread of Lyme disease into new regions.
- The Lyme vaccine does not protect against the multitude of other tick-borne pathogens.
Challenges for tick vaccines
- Multiple Species of Ticks. In the US Blacklegged ticks, and Western blacklegged ticks, are the vector for Lyme disease, but there are many other species of ticks: lone star ticks, American dog ticks, Rocky Mountain wood ticks, Pacific Coast ticks, soft bodied ticks, Gulf Coast ticks, and brown dog ticks. All of these ticks play important role in a variety of human diseases, with several tick species capable of transmitting multiple pathogens in one bite. (Eisen, Kugeler, Eisen, Beard, & Paddock, 2017)
- Ticks Carry Multiple Pathogens. In addition to Borrelia, ticks are known to transmit multiple other pathogens: Anaplasma, Babesia, Ehrlicia, Rickettsia, and several viruses. Just like Borrelia each of these pathogens have multiple species. Currently, there are 16 tick-borne diseases recognized by the CDC of the United States, with new pathogens being discovered every year.
- OspA Vaccine for Mice. An OspA Vaccine (E.coli OspA RTV) has been developed for mice that is administered through a bait box. A recent study demonstrated after five years 76% fewer tick nymphs were infected with Borrelia burgdorferi.(Gomez-Solecki 2014))
- OspA Vaccine for Mice. Another vaccine under development for mice combines OspA with a virus (Vaccinia) and would purportedly only require a single dose. (Hu 2006)
- Anti-tick Vaccine. There are multiple proposals for anti-tick vaccines. Those that target the tick saliva, the mid-gut of the tick, and several that promote antigens against ticks—similar to those used in veterinary medicine. In Europe, seven academic partners in six countries have been funded by the European Union in a coordinated effort, called ANTIDotE, to develop an anti-tick vaccine that would provide protection against tick bites. (Sprong 2014) Possibly the most promising aspect of tick vaccines is that they reduce the fertility of the tick and would result in fewer tick-borne diseases in the long run.
- Immediately increase funding for tick control and tick-borne disease research.
- Promote a 21st Century Precision Medicine approach to tick-borne diseases. (Embers 2013)
- Develop rapid tests capable of detecting Lyme and HLA defects prior to vaccine.
- Design safe, efficient, transparent, vaccine trials that are evaluated by a blinded third party.
- Begin using chemical tick control measures that are already FDA-approved.
- Yard sprays that are wildlife, bird and bee safe.
- Permethrin treated socks and shoes.
- USDA “4-poster” stations that treat deer.
- Bait boxes that apply topical pesticide to mice.
- Ball R. (2001) Powerpoint on the Lymerix Vaccine, LYMErix® Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS), https://www.lymediseaseassociation.org/images/NewDirectory/Government/Vaccines/2001_fda_powerpoint_RobertBall.pdf
- Brock TD, et al. (1994) Biology of Microorganisms, 7th ed. Prentice Hall, NJ, USA. Introduction to Spirochètes. University of California Museum of Paleontology.
- Burgdorfer W, Barbour AG, Hayes SF, Benach JL, Grunwaldt E, Davis JP. (1982). Lyme disease-a tick-borne spirochetosis? Science, 216(4552), 1317-1319.
- Cerar T, et al. (2016) Differences in Genotype, Clinical Features, and Inflammatory Potential of Borrelia burgdorferi sensu stricto Strains from Europe and the United States. Emerging Infectious Diseases. 2016,22(5):818-827. doi:10.3201/eid2005.151806
- Comstedt P, et al. (2017) The novel Lyme borreliosis vaccine VLA15 shows broad protection against Borrelia species expressing six different OspA serotypes. Plos. https://doi.org/10.1371/journal.pone.0184357
- Cutler SJ, Ruzic-Sabljic E, Potkonjak A (2016). "Emerging borreliae - Expanding beyond Lyme borreliosis". Molecular and Cellular Probes. doi:10.1016/j.mcp.2016.08.003. PMID 27523487.
- Eisen RJ, Kugeler KJ, Eisen L, Beard CB, & Paddock CD. (2017) Tick-Borne Zoonoses in the United States: Persistent and Emerging Threats to Human Health. ILAR J, 1-17. doi:10.1093/ilar/ilx005
- Elsner R, Hastey CJ, Baumgarth N. (2015) Suppression of long-lived immunity following Borrelia burgdorferi induced Lyme disease. PloS Pathogens, 11: e1004976.
- Embers M, et al. (2017) Variable manifestations, diverse seroreactivity and post-treatment persistence in non-human primates exposed to Borrelia burgdorferi by tick feeding. PlosOne, https://doi.org/10.1371/journal.pone.0189071
- Embers M, Narasimhan S. (2013) Vaccination against Lyme disease: past, present, and future. Frontiers in Cellular and Infection Microbiology 3(6):6 · DOI: 10.3389/fcimb.2013.00006
- Fawcett PT, Rose CD, et al. (2001) Effect of Immunization with Recombinant OspA on Serologic Tests for Lyme Borreliosis. Clin Vaccine Immunol vol 8, no 1 79-84 doi: 10.1128/CDLI.8.1.79-84.2001
- Frasier CM, et al. (1997) Genomic sequence of a Lyme disease spirochaete, Borrelia. Nature volume 390, pages 580–586
- Gomes-Solecki, M. (2014) Blocking pathogen transmission at the source: reservoir targeted OspA-based vaccines against Borrelia burgdorferi. Front Cell Infect Microbiol. 2014; 4: 136 doi: 10.3389/fcimb.2014.00136
- Gross DM, et al. (1998) Identification of LFA-1 as a Candidate Autoantigen in Treatment-Resistant Lyme Arthritis Science 31 Jul 1998: DOI: 10.1126/science.281.5377.703
- Hodzic E, Imai D, Feng S, Barthold SW. (2014) Resurgence of persisting non-cultivable Borrelia burgdorferi following antibiotic treatment in mice. PLoS One, Jan 23;9(1):e86907. doi: 10.1371/journal.pone.0086907.
- Hu LT, et al. (2006) Protective efficacy of an oral vaccine to reduce carriage of Borrelia burgdorferi (strain N40) in mouse tick reservoirs. Vaccine. doi: 10.1016/j.vaccine.2005.10.044
- Keller A, Graefen A, et al (2012) New insights into the Tyrolean Iceman’s origin and phenotype as inferred by whole-genome sequencing. Nature Communications vol 3, Article number 698
- Latov N, et al. Neuropathy and cognitive impairment following vaccination with the OspA protein of Borrelia burgdorferi. J Peripher Nerv Syst. 2004 Sep;9(3):165-7. DOI: 10.1111/j.1085-9489.2004.09306.x
- Marconi RT, et al. (2017) Identification of a defined linear epitope in OspA protein of the Lyme disease spirochetes that elicitis bactericidal antibody responses: Implications for vaccine development. Science Direct. https://doi.org/10.1016/j.vaccine.2017.04.079
- Marks DH. Neurological complications of vaccination with outer surface protein A (OspA). Int J Risk Saf Med 2011; 23: 89–96.
- Poinar G. (2015) Spirochete-like cells in a Dominican amber Ambylomma tick (Arachnida: Ixodidae) Historical Biology. Jan 2014, Volume 27,2015-Issue 5
- Porcella SF, Schwan TG. (2001) Borrelia burgdorferi and Treponema pallidum: a comparison of functional genomics, environmental adaptations, and pathogenic mechanisms. J. Clin Invest, 10.1172/JCI12484
- Rose CD, Fawcett PT, Gibney KM. (2001) Arthritis following recombinant outer surface protein A vaccination for Lyme disease. J Rheumatol. Nov;28(11):2555-7.
- Rosenberg R, et al. (2018) Vital Signs: Trends in Reported Vectorborne Disease Cases — United States and Territories, 2004–2016 Weekly / 67(17);496–501
- Sheller S. (2013) “It’s Time to Develop a Vaccine for Lyme Disease, Doctor Says” Op-Ed. Philladelphia Enquirer. https://www.lymediseaseassociation.org/images/NewDirectory/Government/Vaccines/2013_LymeOp_Ed_Sheller.pdf
- Stricker R, Johnson L. (2014) The Lancet. Lyme disease vaccination: safety first. DOI: https://doi.org/10.1016/S1473-3099(13)70319-0
- Smith P, Gaito A, Marks, DH. (2002) Transcript of FDA Lymerix meeting, Bethesda, MD. https://www.lymediseaseassociation.org/about-lyme/controversy/vaccine/261-lymerix-meeting
- Sprong H, Seemann I, et al. (2014) ANTIDotE: anti-tick vaccines to prevent tick-borne diseases in Europe. Parasites and Vectors. https://doi.org/10.1186/1756-3305-7-77
Lonnie Marcum, PT
Written Testimony to the Tick-borne Diseases Working Group Meeting #6
June 21, 2018
Tick-borne Diseases Are a Big Problem in California
By Phyllis Mervine, President and Founder, LymeDisease.org
When I was selected as a member of the TBDWG Subcommittee on Disease Vectors, Surveillance, and Prevention, I felt part of my responsibility was to represent my home state of California. The CDC maps with their myriad little black dots make it look like Lyme and other tick-borne diseases (TBDs) barely exist in California and on the West Coast. We who live here know they do—at least 10 tick-borne diseases occur in California, with Lyme disease being the most prevalent. In this paper, I will discuss some of the scientific evidence and unique features that make California high risk for acquiring Lyme disease and other TBDs.
After growing up in Connecticut and living in Lyme-endemic areas much of my youth (south of England, southern Germany), I finally contracted Lyme disease in Mendocino County, which is in the coastal range of northern California. No one knew it then, but the incidence of Lyme disease in my rural community would turn out to rival that of highly endemic areas that had been studied in the Northeast. But it was 1977, and no one even knew what Lyme disease was in those days. I got the flu-like illness and swollen knee, and then, months later, severe arthritis of the spine and other symptoms. I was diagnosed with an autoimmune disease which I lived with for 10 years. Ten long years when I felt like death warmed over, struggling to get through each day, with pain, extreme fatigue, and no hope for a cure.
It wasn’t until 1987 that I was finally properly diagnosed and treated for Lyme disease. After three years of oral antibiotics, I could plan my life more than one day at a time. It was a good thing, because by then I had started trying to educate my community about it. My efforts led to a newsletter—The Lyme Times—which rapidly grew into a nationally distributed lay journal, and then I started a nonprofit to provide education and support to people with Lyme disease. This eventually became LymeDisease.org. If raising five kids and running a homestead wasn’t enough to keep me busy, my new work was. The interest was huge; the need was great.
I have to thank my mentors. Paul Lavoie, MD, and Robert Lane. I had the great good fortune to meet Dr. Lavoie, an early Lyme expert, at a critical time in my life. He treated me for chronic Lyme disease and encouraged my first steps in what became my vocation. And UC Berkeley entomologist Robert Lane, with whom (along with many post docs and other students) I collaborated on his studies of my property and around the county for many years. I learned so much from both of them and we in California feel so blessed to have been on the receiving end of their intellectual curiosity and painstaking work. Sadly, Paul Lavoie died when he was only 60, so we can’t know what amazing things he would have done had he had more time. But Bob Lane had a full and illustrious career, publishing scores of peer-reviewed papers and mentoring many young scientists who follow in his footsteps today.
Before I knew him, in the 1980s, Lane worked with Willy Burgdorfer and others to establish that adult western black-legged ticks could be vectors of Lyme disease in northern California. The fact that one third of the ticks had generalized infections was thought to have implications as to the speed with which transmission is likely to occur.(1) We now know that those ticks harboring generalized spirochetal infections probably were infected with the relapsing fever group spirochete Borrelia miyamotoi, which wasn’t described until 1995.
Using blood samples obtained in 1987-89 from residents of a northern California community at high-risk (CHR), Lane et al. examined intraspecies differences between B. burgdorferi isolates B31 (a New York strain) and CA5 (a California strain). They discovered that five of 24 (21%) blood samples differed significantly in their production of antibodies against B31 vs. CA5. This discrepancy may cause falsely negative test results when using FDA-approved commercial ELISA tests—all of which use B31 as the antigen—in people infected with CA5-like isolates.(2) People infected in California—or any other area with diverse Borrelia species—may be at a special disadvantage with the CDC testing protocol.
Brown and Lane found that transmission cycles were more complex than those on the East Coast and involved woodrats as reservoirs and a tick that did not bite humans.(3) Meanwhile Boyce et al. were exploring the diversity of Borrelia in California, including southern California.(4) Later papers expanded on this diversity and eventually California emerged as the state with the most diverse group of Borrelia in the US. Globally, around 20 different genospecies of Lyme disease group spirochetes have been described so far, six of which occur in California. In 2017 Margos et al. note the “particularly high” diversity of Borrelia species discovered in California and proposed the name Borrelia lanei sp. nov. for a recently identified genospecies in honor of Robert Lane.(5)
In a paper published in 1992, Lane et al. showed that the seroprevalence rate for the CHR residents was as high or higher than that determined for most other high-risk communities or occupational groups (e.g., outdoor employees) that have been studied in the northeastern United States. The cumulative frequency of seropositivity for Lyme disease in the study population was a whopping 24%. The physician associated with the study—my doctor, Paul Lavoie--clinically diagnosed 37% of the participants with definite or probable Lyme disease.(6)
The medical community was skeptical of the results—how could so many people have Lyme disease when the infection rate of ticks in California was known to be in the low single digits? Clover and Lane then discovered that nymphal ticks were responsible for most cases of human infection. Not only did nymphs have a higher infection rate than adults, but attachments by nymphs coincided with the seasonal occurrence of most cases of Lyme disease.(7) Their higher infection rate helped to explain why Lyme disease was so common in certain rural communities despite a low infection prevalence in adult ticks but raised further questions. Why was the nymphal tick infection rate higher? It seemed counterintuitive. The discrepancy led researchers to investigate the role of the western fence lizard—a favored host of nymphal ticks—and other lizards in the transmission cycle of Borrelia spirochetes. They discovered that complement in lizard blood kills Borrelia spirochetes in attached nymphs and significantly reduces infection rates in, and disease risk to, adult ticks.(8) Swei et al. later discovered that western fence lizards play a dual role in the ecology of Lyme disease. Specifically, they also may increase disease risk by maintaining higher densities of subadult ticks and therefore, higher density of infected nymphs.(9)
I followed up with the same individuals from CHR ten years later in a poster at the ICLB in Munich looking at long term clinical outcomes. Using a standardized symptom assessment tool, I interviewed 70 people, 50 of whom had sought medical advice for continuing health problems that may have been Lyme-related. All but two respondents had been bitten by ticks multiple times.
The total number of complaints for all systems was significantly higher in the Lyme group than in the non-Lyme group. There was a significantly higher prevalence of neurologic complaints in the Lyme group than in the non-Lyme group. Seven individuals (17%) in the non-Lyme group had very high composite symptom scores (avg. 20.0, range 15-24); These individuals had a high number of neurologic and musculoskeletal complaints, comparable to the Lyme group. They also had higher (i.e. worse) scores in all other categories. I thought they might have undiagnosed Lyme disease. Local doctors however were offering people antidepressants, sedatives, anti-inflammatory drugs, and physical therapy, and not antibiotic treatment. Only two doctors suggested Lyme as a possible diagnosis.(10)
Working in a semi-rural community an hour from CHR, Fritz et al. discovered that ticks in northern California carry Ehrlichia and Babesia in addition to Borrelia. He emphasized that the risk of infection with these emerging tickborne diseases, particularly in children, may be greater than previously recognized.(11)
After more than 10 years of dragging flannels through leaf litter and manually removing ticks from mouse ears, Eisen and Lane felt compelled to state in one paper, “The high densities of infected nymphs recorded at the CHR suggest that, despite the low statewide incidence of Lyme disease, the medical community should be alerted that Lyme disease can be highly endemic in rural areas of northwestern California.”(12) In another paper, after finding 79% of the CHR study subjects were positive for anti-arthropod saliva antibodies to I. pacificus, Lane et al. suggested that testing for anti-arthropod saliva antibodies might be a useful epidemiologic tool for studying emerging tick-borne infections.(13) But academic research doesn’t always trickle down to medical practice, or if it does, very slowly. Their words fell on deaf ears. I can count the Lyme-literate doctors in the county on one hand, in Northern California, on two. But that’s also because of the politics of Lyme. It will take a generation to change.
I must give a call out to Lars and Becky Eisen, now at the CDC in Fort Collins, for their excellent work. Lars and colleagues found that there were extraordinary variations in density rates of infected nymphal ticks (11-97 fold at one site) from year to year that were only partly explained by environmental factors.(14) He and colleagues established that the western gray squirrel and certain bird species were important hosts of Borrelia. Birds utilizing tick-questing substrates, such as leaf litter in dense woodlands, had 20-fold higher nymphal loads relative to woodrats and mice. Lizards carry a disproportionate share of larvae and nymphs compared to those rodents.(15)
Lane et al. established that only the western gray squirrel, Sciurus griseus, fulfilled the major criteria for a reservoir host of B. burgdorferi s.s., i.e., 47% of I. pacificus larvae (n = 64) and 31% of nymphs (n = 49) removed from squirrels contained B. burgdorferi s.l.(16) Salkeld and Lane confirmed the role of the western gray squirrel, the only source of infected nymphs, as a primary reservoir for Borrelia burgdorferi in northern California.(17)
Eisen et al. created a model of high acarologic (tick-related) risk sites in California based on a number of variables collected from known high-risk areas. “Lyme disease incidence in zip code areas containing habitat with high projected acarologic risk was 10-fold higher than in zip code areas lacking such habitat and 27 times higher than for zip code areas without this habitat type within 50 km.” They found “Southern zip-codes from which Lyme disease cases had been reported were commonly located in close proximity to areas with high projected acarologic risk.”(18)
After recently finding evidence of B. miyamotoi infection in human blood samples collected at the CHR in northwestern California in 1988-89, Peter Krause et al. called urgently for improved relapsing fever group spirochete antibody assays. Cross-reacting antibodies could not be ruled out.(19)
Forty years into the epidemic, I no longer believe I will see the battle completely won for patients in my lifetime, but I know I’ve been fighting on the right side. I’ve seen and talked to a lot of Lyme patients over the years and don’t always have good answers for them. My friend who probably has Lyme but is being treated for MS with immune suppressants. A person who told me she had had Lyme, but was cured, and now she has fibromyalgia. Another friend who died from ALS several years after a tick bite on his head. I know several local children with diseases like mild Asperger’s, autism and atypical epilepsy and wonder if they could have acquired Lyme from their mothers in utero and now it’s in their brains. Maybe time will tell. We just have to reach more doctors with the science.
I hope the Tick-Borne Diseases Working Group will live up to its promise. Patients need answers and their numbers are multiplying.
- Burgdorfer W, Lane RS, Barbour AG, Gresbrink RA, Anderson JR. The western black-legged tick, Ixodes pacificus: a vector of Borrelia burgdorferi. Am J Trop Med Hyg. 1985 Sep;34(5):925-30.
- Lane RS, Lennette ET, Madigan JE. Interlaboratory and intralaboratory comparisons of indirect immunofluorescence assays for serodiagnosis of Lyme disease. JJ Clin Microbiol. 1990 Aug;28(8):1774-9.
- Brown RN, Lane RS. Lyme disease in California: a novel enzootic transmission cycle of Borrelia burgdorferi. Science. 1992 Jun 5;256(5062):1439-42.
- Boyce WM, Brown RN, Zingg BC, Lefebvre RB, Lane RS. First isolation of Borrelia burgdorferi in southern California. Med Entomol. 1992 May;29(3):496-500.
- Margos G, Fedorova N, Kleinjan JE, Hartberger C, Schwan TG, Sing A, Fingerle V. Borrelia lanei sp. nov. extends the diversity of Borrelia species in California. Int J Syst Evol Microbiol. 2017 Oct;67(10):3872-3876. doi: 10.1099/ijsem.0.002214. Epub 2017 Sep 8.
- Lane RS, Manweiler SA, Stubbs HA, Lennette ET, Madigan JE, Lavoie PE. Risk factors for Lyme disease in a small rural community in northern California. Am J Epidemiol. 1992 Dec 1;136(11):1358-68.
- Clover JR, Lane RS. Evidence implicating nymphal Ixodes pacificus (Acari: ixodidae) in the epidemiology of Lyme disease in California. Am J Trop Med Hyg. 1995 Sep;53(3):237-40.
- Lane RS, Quistad GB. Borreliacidal factor in the blood of the western fence lizard (Sceloporus occidentalis). J Parasitol. 1998 Feb;84(1):29-34.
- Swei A et al. Impact of the experimental removal of lizards on Lyme disease risk. Proc Biol Sci. 2011 Oct 7;278(1720):2970-8.
- Mervine P, Stricker RB. Long term clinical outcomes among residents of an endemic community in northern California. Poster, International Conference on Lyme Borreliosis, 1999, Munich, Germany.
- Fritz CL, Kjemtrup AM, Conrad PA, Flores GR, Campbell GL, Schriefer ME, Gallo D, Vugia DJ. Seroepidemiology of emerging tickborne infectious diseases in a Northern California community. J Infect Dis. 1997 Jun;175(6):1432-9.
- Talleklint-Eisen L, Lane RS. Variation in the density of questing Ixodes pacificus (Acari:Ixodidae) nymphs infected with Borrelia burgdorferi at different spatial scales in California. J Parasitol. 1999 Oct;85(5):824-31.
- Lane RS et al. (1999) Anti-arthropod saliva antibodies among residents of a community at high risk for Lyme disease in California. Am J Trop Med Hyg 61: 850–859.
- Eisen L, Eisen RJ, Chang CC, Mun J, Lane RS. Acarologic risk of exposure to Borrelia burgdorferi spirochaetes: long-term evaluations in north-western California, with implications for Lyme borreliosis risk-assessment models. Med Vet Entomol. 2004 Mar;18(1):38-49.
- Eisen L, Eisen RJ, Lane RS. The roles of birds, lizards, and rodents as hosts for the western black-legged tick Ixodes pacificus. J Vector Ecol. 2004 Dec;29(2):295-308.
- Lane RS, Mun J, Eisen RJ, Eisen L. Western gray squirrel (Rodentia: Sciuridae): a primary reservoir host of Borrelia burgdorferi in Californian oak woodlands? J Med Entomol. 2005 May;42(3):388-96. Erratum in: J Med Entomol. 2005 Jul;42(4):iv.
- Salkeld DJ, Lane RS. Community ecology and disease risk: lizards, squirrels, and the Lyme disease spirochete in California, USA. Ecology. 2010 Jan;91(1):293-8.
- Eisen RJ, Lane RS, Fritz CL, Eisen L. Spatial patterns of Lyme disease risk in California based on disease incidence data and modeling of vector-tick exposure. Am J Trop Med Hyg. 2006 Oct;75(4):669-76.
- Krause PJ, Carroll M, Fedorova N, Brancato J, Dumouchel C, Akosa F, Narasimhan S, Fikrig E, Lane RS. Human Borrelia miyamotoi infection in California: Serodiagnosis is complicated by multiple endemic Borrelia species. PLoS One. 2018 Feb 8;13(2):e0191725. doi: 10.1371/journal.pone.0191725. eCollection 2018.
To the Working group on Tick Borne Illness:
Thank you for the time you have dedicated away from family and friends to serve the public.
Canada and England have already included professional tick testing as one data point in the Physicians overall assessment of risk of tick borne illness for a patient.
Would you consider recommending this valuable tool, as just one measure a health care provider should consider, when evaluating the overall risk to the patient.
Would you consider encouraging the American Red Cross to test for other tick borne illnesses, in addition to babesiosis. This screening would help to identify patients who do not realize they carry a infection and would add another layer of safety to protect recipients.
Realizing that every minute counts with respect to properly removing ticks before they transmit disease. There are many schools that do not have a tick removal policy or have one that requires parents to drive to the school to remove the tick from their child themselves. Each school has its own process on how to develop and approve policy. Could this group give a consensus recommendation on a model tick avoidance and removal policy. Perhaps this policy would also allow students ( of proper age) to be able to bring and self apply repellent without a prescription from their health care provider.
Thank you for your service and your consideration.
George W. Monks, MD
Vice President, Oklahoma State Medical Association
This is my life threatening story of Alpha Gal.
In April, the spring of 2018 I had been bitten by a tick on the base of the lower part of my spine. It had bitten me on an old back surgery scar from twenty years ago. The tick had been removed as any other tick we get here on the farm, but it stayed inflamed & itching for weeks. I applied a salve we use to help the pain & itching to subside, but without avail. I ask my husband to check it several times just to see what was going on, but it was just the same. I was extremely exhausted & could not stop dragging. I even went to my Dr & we got a game plan increasing my supplements & to get more nutritional value in my diet. Nothing was helping, I was only feeling worst.
I was preparing for a meeting at my house, & others had prepared the meal. We are not red meat eater at our house. But, this night we had been served a big beef roast covered in gravy. I began eating & became very nauseated, tried to excuse myself from the table & couldn’t even walk by myself. My husband helped me to the couch where that was the last thing I remember. The rest is the story I have been told by my family/friends & Doctors.
My husband & friends (who was a Dr & nurse) had to carry me from my house down 15 steps to the vehicle. Our Dr Friend call ahead to the hospital where he worked & had them ready for us when we arrived. We live 40 minutes from the hospital. When we arrived they done a CT scan & hooked me to IV’s.
They couldn’t find anything, & ending up Life-flighting me to a hospital in Little Rock, AR. I was admitted to ICU, still not cognitive of anything. They were administering meds for viral/bacterial infections they believed to be causing the Encephalitis. This was on the evening of April 27th & I began to come around the following day, but only to severe hallucinations that were so real; & still was very challenged in my motor skills & cognitive abilities. Amazing journey! By Saturday evening I began to make progression toward moving, hear, seeing, understanding, & comprehending. By Sunday evening I was released back to follow-up with my Primary Care Dr.
Follow-up with my Dr the May 7th. I was prescribed Doxycycline for 30 days; along with increase of supplements. Not feeling well, at all.
Ahead to Memorial Day; out of town friend cooking out & they were cooking hamburgers & hotdogs. I ate both hamburgers & hotdogs in the evening, visited a little, & went to bed about 10pm. I was sound asleep, when awakened with what felt like bites; itching all over, extreme itching on my hands & feet. I took 50mg Benadryl, & took a shower hoping it would help calm the itching. I began feeling my tongue swelling & woke my friend & husband to get me some more Benadryl 50mg. Still no relief; they began rubbing oil on my hands & feet to calm the itching without relief. Took 50mg more of Benadryl & my husband took me to a nearby hospital 10 minutes away. They administered a long acting steroid & I began to be able to feel air back to my windpipe. Scary!
Returned home May 29th; contacted Dr office; had an appointment to be 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.
All red meats were eliminated even as an option in my life. 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. Stopped my supplements & my energy improved; stopped my hand cleaning products, even better; shampoo, toothpaste, soap, better. I was in shock! All along these products were causing this Alpha Gal to play havoc in my body.
I truly would be willing to do anything to feel better. This disease could have ended my life, or disabled me. I am a Certified Natural Farmer & 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 & educate to prevent tick borne disease.
Anonymous Comment 1
My two youngest are Lyme and babesia positive, they were diagnosed at Aprox 4 years and 12 months old via a MD as having borelia. Since the diagnoses, we have paid out of pocket to try to save are kids lives and give them some ease of the symptoms. We are low income and have OHP, Drs in primary care clinics keep telling us lyme isn't here so no way our kids have it. We have multiple specialty labs saying are kids do have it, as well as viral load and imune disfunction. The symptoms are often times disabling. We travel and pay put of pocket for Drs who specialize and keep up on training in tick-borne disease. Without this care our son would most likely be dead. Tick-born disease is very real; it's even deadly. Who is helping the lower class families, where are the knowledgeable primary care Drs who listen? For those who didn't get that early diagnoses where is the longer term care and treatment? These sick children - how are they going to be a productive next generation when insurance and primary care Drs won't help them get better as youths, leaving these kids to age and become physicaly as well as mentaly ill? How long can parents keep on adding more credit card bills and debt? When of age, how will these children hold down jobs or pay there own medical bills? The next generation are kids now that have tick-borne disease need trained knowledgeable Drs who listen and understand the full body issues that come with tick-borne disease. They need medical care asap.
Thank you for your time. Please help not only the kids but the aging who some are caregivers as well.
Anonymous Comment 2
Recommend that one of the "Centers for Excellence" be devoted exclusively to pathology of human specimens for TBD, using and expanding direct detection methods.
It has been decades (!) since Dr Alan MacDonald discovered an association between Alzheimer's and Borrelia, confirmed independently by Dr Miklossy. Alzheimer's biobanks exist and should be further utilized as a priority.
Anonymous Comment 3
Tick Borne Disease Working Group:
I can testify that I and millions of other people have and do truly suffer from what would be diagnosed as Lyme disease and Chronic Lyme disease, and what may be called Post Lyme Syndrome (a term that needs differentiation as it appears to indicate that Borrelia is eradicated and symptoms continue).
Those with Lyme disease, and if it must be differentiated, “chronic Lyme” disease, are depending on you. We have suffered for decades and we continue to be denied treatment and federal and private disability.
Are the recommendations going forward going to admit that the testing for Lyme is completely inadequate, leaving most to suffer undiagnosed?
Will it finally be recognized that a positive blood culture is a valid test to provide evidence of a positive indication of Lyme?
Will it finally be recognized that a negative blood culture does not necessarily indicate that Borrelia is not present, just that it was not found in that testing.
Will it finally be recognized that a negative Lyme test after receiving treatment does NOT indicate Lyme has been eradicated, especially if symptoms persist?
How many patients have to provide statements regarding manifestation of symptoms when current testing methods indicate they are negative for the presence of Borrelia? How many scientific articles must present this as true?
Will the recommendations finally acknowledge the countless scientific articles and research results that
- provide indisputable evidence that Lyme disease testing is inaccurate;
- a short-course of antibiotics is inadequate to cure most cases of Lyme disease;
- chronic Lyme disease does exist;
- and Lyme and chronic or post Lyme disease is disabling?
Will ALL the scientific articles and research (not just the articles sanctioned by a minority in past control of guidelines) finally have influence on guidelines for the diagnosis and treatment of Lyme disease and co-infections? Why have ALL the scientific articles and research not been used to influence the guidelines as of yet? (For a list of these articles I recommend referring to “Why Can’t I Get Better?” and “How Can I Get Better” by Richard Horowitz, M.D. and articles referenced by Bay Area Lyme.)
Will it finally be acknowledged that Lyme disease is debilitating and is extremely painful? This has been documented. While Lyme disease patients have been ignored and mistreated by the medical community for decades, they have suffered in every way - physically, financially, and spiritually/emotionally. The many people with Lyme have had their physical and mental abilities devastated. They have had a productive positive life replaced by one that consists of fighting to survive the excruciating pain and severe discomfort that is Lyme. They have lost the ability to earn a living while being financially ruined by exorbitant medical costs. We are fighting for our lives while doctors are much of the time, either rude and insulting, or simply unsupportive, as they think that our illness is dramatics or somatic. The scientific community, countless Lyme patients, and the few Lyme-literate medical professionals have scientific evidence that our illness is not dramatics or somatic but is based on real physical cause and effects. We need the medical community to be educated immediately! Every single day that their ignorance continues, is one that we have to endure through significant pain and suffering with very limited help. Lyme occurs in every state, and likely every county. It is NOT easy to accurately test for Lyme. It is NOT cured with a short-term course of antibiotics, and from talking with hundreds of Lyme patients, it’s not even assuredly cured with a long-term course of antibiotics. But the medical community has been educated with misinformation for decades, while we have lost our physical and mental abilities, our livelihood and purpose - our health and our lives.
Will the recommendations acknowledge that Lyme disease causes such great amounts of pain, that patients shall be permitted pain management medicines? The current pain policy in this country has resulted in patients with very legitimate pain management needs either going without any pain management or having their treatment dictated by the health insurance companies. Pain management treatment is being completely dictated by FOR PROFIT companies that do not want to pay for prescription pain management - pain relief for people in great need. Treatment now consists of “4 pills” of pain management medicines. It doesn’t matter the dose, just that there be only 4 pills prescribed. Patients would have to pay for additional pills, if they were allowed them, but as most providers are afraid of getting into legal/ federal trouble over pain management, they make their treatment of patients conform to the health insurance policy on payment (thus, they will only prescribe the 4 pills, no matter the pain level). Why are for-profit companies allowed, actually encouraged, by current policy, to dictate the pain management treatment? It does not matter what the need for pain relief is even though the scientific literature has shown that Lyme disease is extremely painful and that pain management is in the best interest of those in pain (pain left unmanaged negatively impacts and changes the brain). There may be some illness that is as painful, but I can attest to the fact there is no illness that is more painful than Lyme Disease. The pain from Lyme disease is literally torture. The pain, at its worst, which it is for many of us, can be imagined as if one was having every single muscle and joint being ripped from their body, every moment of every day. We are forced to live through this pain while fighting to not only remain alive but also to find treatment for our illness (which goes ignored and made light of by the medical community and health and disability insurance/systems.) Will the recommendations acknowledge the pain of this disease and that it is inhumane and unconscionable to continue to enable health insurance companies and erroneous pain management theory dictate pain management treatment? Will you recommend that Lyme patients (those an LLMD determines as having Lyme disease rather than a faulty test) be given adequate pain management treatment, and that their needs will likely be significant and continue for long periods of time?
It has been said that the Tick Borne Disease Working Group is going to only look from this point onward. If that is what is to be done, errors of the past will never be accounted for, and it will be very difficult to re-educate and elicit change in the medical community and health and disability insurance/systems. Will the recommendations include a timeframe that will outline and provision how long is it going to take until Lyme patients get adequate treatment and support from the medical community, health insurance, life insurance, and our state and federal governments (Medicare, Medicaid, and social security disability programs and policies)?
Will the recommendations include a statement concerning public awareness campaigns that will provide accurate information about Lyme: it is not rare, it is not easy to test for or to treat, and it is not at all easily cured, if it is ever cured (only goes into remission)?
Will the working group make recommendations that judges will receive when they make judgements on federal and private disability insurance cases? Will there be recommendations that result in private disability insurance companies and medical professionals not being able to deny our claims based on their determination that “Lyme is not disabling?” If not, why not? Is it the working group’s view that Lyme; is not rare, that it is very painful and very disabling, is not easy to test for or to treat, and is not at all easily cured if left undiagnosed for a time - if it is ever cured (only goes into remission)?
ERISA currently results in the private disability insurance companies being able to deny cases based on whatever determination they come to, based on whatever faulty logic and facts they want to claim. The companies have the “discretion.” They are in no way penalized for denying valid claims (they will not have to pay disabled customers more if they are sued and found to have made an incorrect and immoral determination). We have 3 years from the first date of disability to bring a lawsuit against the private insurance companies when they falsely deny us. We also are not able to add anything to the “Claim File” after the disability company has suddenly determined that they have made a final determination with no appeals allowed. Due to ERISA, this claim file is all that a judge in a lawsuit for benefits will ever see. While Lyme patients only have a short time - until the disability companies decide they are making a “final determination” - to add information to our claim file, we are further impaired by the lack of support by the medical community that our diagnosis and our illness is “real”. The suppression of facts and the oppression resulting from misinformation results in Lyme patients having a very difficult time getting a diagnosis that the medical community, insurers, and the judicial community takes seriously and understands. Given that, how are we to win our valid private disability insurance cases? I have to file a lawsuit against a private disability insurer by September, as they have determined that “Lyme is not disabling.” Will accurate information about Lyme be disseminated in time to be of influence on my court case? When will it be disseminated? Why should the private disability insurance companies not have to pay our valid claims, and we instead be solely the burden of the tax payers? How will we get federal disability benefits if the medical community continues to believe that Lyme disease is not a “real” illness and is easy to test for with a Western Blot test and then easy to cure? Every day the truth about Lyme is not disseminated, we are losing our potential incomes and becoming burdens. Will you please recommend that ERISA guidelines not be allowed to enable private disability companies to benefit from both PAST and FUTURE denial of claims based on the determination that “Lyme is not disabling”. Thus, recommend that a judgement regarding ERISA protections be made. Recommend:
- the private disability insurance companies no be longer protected by any statements regarding a limitation of time-to-take-to-court when they have made invalid claim denials.
- the wrongly-denied claim files are not frozen when the companies determine the claim closed.
- the USA HHS and CDC support the determination that Lyme is disabling.
Since it often takes many years to get an accurate diagnosis of Lyme disease (and many other illnesses), patients also need for private insurance companies to also not be able to make a determination of “pre-existing condition” on a case of newly identified Lyme disease. Please include these disability and ERISA influencing provisions identified in your recommendations. If you can not, why not?
Much of the time, those with Lyme disease have other illnesses, such as chronic fatigue syndrome due to multiple viruses and immune deficiency. These are also diseases that have gone neglected by the medical community. These are also diseases that the standard antibody-based tests do not diagnose correctly. A person does not make antibodies if they can’t make antibodies. Therefore, an antibody test is going to result in a negative finding. Not producing antibodies does not at all mean a person does not have the viruses that cause illness. Why do most doctors not understand that? Why do most not even consider looking for that scenario when a patient with multiple symptoms or a “mystery illness” come to them? Will there be a mass education effort about Lyme and immune illnesses be funded and put in place?
Will the recommendations please acknowledged that as Lyme patients have been failed in so many ways for so very long, we REALLY cannot be asked to be burdened with any more or any continued failures? Please don’t allow Lyme disease to continue to be listed amongst the inhumane and cruel medical mistakes of our country’s medical system. We desperately need immediate acknowledgement and assistance. We need the medical community and the community at large to know that Lyme disease does exist, that it is hard to diagnose, that it is extremely painful (unbearable, thus requiring pain management), and that it is disabling.
Please listen to all those who have commented about how Lyme has destroyed their lives and health. Please listen to your fellow working group and subcommittee members who know from experience, just how painful and disabling Lyme is. Please “listen to” and take note of ALL the scientific literature. Lyme disease patients have been, are, and will be MILLIONS of people. Many of us suffer every moment of every day. We endure what most would never believe is possible to endure. And we suffer and endure while the Lyme guidelines work against us and valid testing and treatment methods, and all and any types of support, are denied us. The literature supports that this is true. Believe us. Believe the science. “Do right by us.” Our lives are in your hands.
Anonymous Comment 4
Dear Members of the Tick-Borne Disease Working Group,
At the last public meeting of the TBDWG, Pat Smith brought up the issue of discrimination against school-age children by their schools. It was mentioned that the ADA protected these vulnerable students and the discussion soon ended.
I am writing to talk about the weaknesses in the federal laws and the many ways that my daughter was discriminated against during her junior high and high school years as well as discrimination that she currently faces when considering attending college.
There are three laws that protect school-age students with disabilities including Section 504 of the Rehabilitation Act (Section 504), the Individuals with Disabilities Education Act (IDEA), and the Americans with Disabilities Act (ADA).
The IDEA is by far the strongest of the federal laws protecting students with disabilities, yet states vary dramatically in the interpretation and implementation of this law. For much of my daughter’s school years we lived on a property that has land and buildings in both Massachusetts and New York, so I am aware of the differences in regulations regarding the interpretation of the IDEA between these two states
, for children who receive extended home and hospital instruction.
Students who are classified under the IDEA receive a much higher level of legal protection and qualify for a much broader range of services than students who are not. In New York, students on extended homebound instruction are usually covered under Section 504. While in Massachusetts, due to differences in state regulations, students who need extended home and hospital instruction are much more likely to be classified under the IDEA.
In the case of my daughter, even though she was never successfully able to return to school attendance after becoming ill with Lyme disease and tick-borne coinfections at the age of 12-years-old; and even though there were a number of years that due to inadequate services, she did not receive credit for a single course, her school district stalwartly maintained that she was “sick” but not “disabled.” As such she was denied numerous special education services during her school years that she would have qualified for had she been classified.
After seven years of applying each year for classification under the IDEA, my daughter was finally classified at the age of 19-years-old, only after failing twice to complete her 12th grade requirements needed for her high school graduation.
The contrast between NY and MA regarding the detailed instructions for services to be provided to homebound students is startling, especially in regard to classifying students who need homebound instruction as disabled under the Individuals with Disabilities Education Act (IDEA). The attached regulations from the Massachusetts DOE do not exist in any form in New York.
The extreme sparseness of the regulations governing homebound instruction in New York, (the links are also pasted below) allow for huge discrepancies in services and resultant discrimination for these vulnerable students as compared to students that are able to attend school.
Since the many states are not giving sufficient protection to these vulnerable students, more guidance is needed from the federal government and could be provided in the form of amendments to these federal laws.
During her school years, some of the ways that my daughter’s school district discriminated against her included:
- denying her homebound instruction during the summer months when she was unable to complete her requirements during the school year.
- requiring her to go to school to receive her homebound instruction even when she was physically unable to do so.
- assigning tutoring hours to her in ways that she was unable to use them due to the effects of her illness.
- denying her any homebound instruction during the limited periods that she was able to attend classes part-time (one or two classes per day or one day per week).
- neglecting to send home progress reports or grades.
- denying her individual tutoring in mathematics when she was unable to make any progress in her online teleconferencing mathematics courses.
- refusing to pay for her online teleconferencing courses even when New York state was not able to offer her a similar program.
- denying to pay for her neuropsychiatric evaluations from a psychologist who specialized in evaluating students with tick-borne illnesses.
- only offering her the minimum courses that she needed to graduate.
At one point I filed an appeal to the New York State Commissioner of Education regarding the denial of homebound instruction to my daughter when she was only able to attend her private school part-time and I was forced to wait over two and a half years for a response, which basically stated that there were no New York state laws that protected her. If she had been classified under the IDEA, then she would have qualified for the home and hospital services that she needed.
Now that my daughter is of college age, the discrimination against her continues in the form of insufficient protection offered to her under the ADA and Section 504, which governs colleges. One of the major forms of discrimination that she faces concerns the denial of financial aid by almost all colleges to students, who because of disabilities, cannot attend college full-time. I spoke on the phone about this discrimination to the New England Regional Office of Civil Rights and was told that the OCR consistently ruled in favor of colleges who denied financial aid on this basis.
Massachusetts State Regulations Regarding Home and Hospital Instruction
Program Quality Assurance Services
Compliance and Monitoring
Question and Answer Guide on the Implementation of Educational Services in the Home or Hospital
Areas where Massachusetts exceeds New York in providing guidance on Special Education services for homebound students.
10. Are Students With Chronic or Acute Health Issues Always Eligible for Special Education?
The answer depends on the facts of the individual case. Any student with a medical or health condition that is likely to lead to extended school absence(s) or inability to maintain effective educational progress is a reasonable candidate to be referred to the public school district for initial evaluation to determine special education eligibility. Such referrals should take place as soon as it is known that a student's health condition is chronic or acute and is likely to have a negative educational impact, rather than delaying referral or action until the student is absent for significant periods of time or has begun to experience educational failure.
If assessment information indicates that the student's educational progress will be adversely affected as a result of a chronic or acute medical condition that is not temporary in nature, then the Team will likely determine that the student is eligible for special education. An eligibility determination is an individualized decision that depends on the facts of each case. In most cases, if the Team determines the student is eligible, the type of disability as recognized by federal and state special education law will be a "health impairment" (see 603 CMR 28.02(7)(i)). In some cases, the assessments may indicate other types of disability, such as "emotional impairment" or "neurological impairment."
If the student has been evaluated and found eligible for special education, the Team will write an IEP describing the special education and related services that the student needs and the school district will provide. If the student will be out of school for medical reasons for an extended period of time, it is appropriate to include on the IEP educational tutoring as a related service that the student needs in order to access the general curriculum while s/he is in the home or hospital setting. The IEP may be tailored to address expected time periods when the student is unable to attend school, if that is deemed appropriate to meet the unique needs of the individual student.
4. What Requirements Apply if the Student is Likely to Be Confined to Home or a Hospital for More Than 60 School Days?
If, in the judgment of the student's physician, a student with an IEP is likely to remain at home, in a hospital, or in a pediatric nursing home for medical reasons and for more than sixty (60) school days in any school year, the Administrator of Special Education is required, without undue delay, to convene a Team meeting to consider evaluation needs and, if appropriate, to amend the existing IEP or develop a new IEP suited to the student's unique circumstances. (See 603 CMR 28.04(4).) The Department recommends that the Administrator of Special Education convene the Team meeting within 10 school days after the school district is notified that the student is likely to remain at home or in the hospital for more than sixty days. This provision applies to all eligible students, including private school students who have been determined to need special education.
In contrast New York State regulations regarding the provision of Home and Hospital Instruction are very sparse, with few requirements made of the school districts. My daughter was on Home and Hospital Instruction for over 8 years and the sparseness of these regulations left her vulnerable to serious discrimination.
NY State Regulations Regarding Home and Hospital Instruction
Home Instruction Questions and Answers
CR 175.21 Instruction of pupils cared for in hospitals or other institutions which provide for care, custody, and treatment of children for the purposes of State aid.
Pupil (physically handicapped)
Even though the Scales case was decided over 50 years ago, stating that private school students did not have to dis-enroll from their private schools in order to receive homebound instruction from the public school districts, New York state still does not allow for the dual enrollment of homebound students in both the public and private school district unless they are classified as disabled under the IDEA. So there is still no provision under NYS regulations that would actually allow a public school to receive funding for a private school student that needed homebound instruction.
Alternative Science Laboratory Experiences Related to Homebound Tutoring
My daughter never received the alternate science laboratory services required under this regulation and there was no consequence for the school district.