Jill Auerbach
TBDWG,
I am alarmed by the Vaccine and Therapeutics Subcommittee's one sided report especially in regard to the ANTI-TICK Vaccine which in the opinion of many is a far better solution than a Lyme only vaccine. For humans would block multiple pathogens, not just Lyme disease. If used in bait vaccine for reservoir animals would reduce infection rates and probably reduce the tick populations as they would probably not be able to locate another host, especially one that wasn't also vaccinated, thus would die! We must remember that this is caused by ticks and is a HUGE INCREASING environmental problem that has been allowed to continue to spread.
This Lyme only vaccine:
- Would do nothing to fix the environmental problem as humans are a dead end in the cycle of Bb.
- Would do nothing to protect against other pathogens.
- Would allow the ticks and pathogens to continue to increase and spread geographically like wildfire as the have on the past 40+ years.
- Would probably cause vaccinated people to feel overconfident, thus ignore prevention measures leaving them at an increased risk of TBDs.
- Would not protect everyone, and need boosters. In the long run would people remember to get the boosters? What would the expense be?
On the other hand, at least an anti-tick vaccine would protect against other TBDs. and if used (as already being planned) would reduce the infection rate of the ticks in the environment and probably reduce tick population.
Upal Pal, PhD, Professor & Director, VMSC Gradulate Program, a brilliant scientist whom I've previously been in contact with wrote about the ANTI_TICK VACCINE however, it was not even mentioned in the Subcommittee oral presentation at the meeting. He did that and was TOTALLY ignored - after all it IS a much better solution.
I am disturbed by the seeming bias, and lack of balance in this subcommittee and request that people such as Dr. Garth Ehrlich plus others be appointed to correct this. It is NOT at all representative of the patient perspective.
Respectfully,
Jill Auerbach
Tick Research to Eliminate Diseases: Scientist Coalition, Coordinator
Public Integrated Pest Management Work Group, Member
Stop Ticks On People (S.T.O.P.), Board Member
NYS Senator Serino's Advisory Board on Lyme and TBD, Co-chair
Hudson Valley Lyme Disease Association, Chairperson
Dutchess County Legislative Tick Task Force, Member
Federal Coalition on Lyme and Tick-borne Disease, Member
NYS Coalition on Lyme and Tick-borne Disease, Member
Paul Auwaerter
Dear Members of the Tick-Borne Disease Working Group:
The Infectious Diseases Society of America (IDSA) appreciates the opportunity to submit comments to the Tick-Borne Disease Working Group and commends the group for addressing the important issue of vector-borne infections. IDSA is the largest infectious diseases medical society in the United States, representing more than 11,000 physicians and scientists. Our members care for patients of all ages with serious infections, including tick-borne diseases. IDSA is committed to ensuring that patients receive the highest quality care for infectious diseases, including Lyme disease. Society members focus on the epidemiology, diagnosis, investigation, prevention, and treatment of infectious diseases in the U.S. and abroad.
We have great sympathy for patients—and their loved ones—who suffer from both short- and long-term effects of Lyme disease or other conditions. Our goal as infectious diseases physicians, public health practitioners, and scientists is to have all patients achieve the best possible outcomes.
To positively impact federal policy with regard to the prevention, surveillance, diagnosis, treatment, and research of tick-borne diseases, it is important that this working group solicit input from relevant experts. In fact, this is required by the statute that established the working group. Unfortunately, the working group’s efforts to solicit such input have been uneven. Infectious diseases physicians and scientists who understand widely accepted, evidenced-based findings regarding the diagnosis and treatment of Lyme disease were excluded from several of the subcommittees that developed draft recommendations for the working group. Further, the public has been provided with fewer than two business days to provide comments on hundreds of pages of subcommittee reports, with comments due on Mother’s Day. Therefore, with such a tight turnaround time, we cannot comment sufficiently on a large number of recommendations or their bases. Such practices do not appear to reflect an earnest attempt by the working group to solicit input, nor are they in keeping with congressional intent. Perhaps most troubling, the exclusion of scientific input has resulted in some recommendations that, if implemented, could severely harm patients and public health.
IDSA is pleased that some of the subcommittees offer important recommendations that can strengthen the federal response to tick-borne diseases, and we are pleased to offer our support for these recommendations in our comments below. We also express concern about several recommendations that would weaken our rigorous scientific approach to the diagnosis and treatment of tick-borne diseases and subject patients to substandard, ineffective and even dangerous care. We urge the working group to exclude such recommendations from its report. We would welcome theopportunity for ongoing dialogue with the working group to help ensure that its recommendations best serve the interests of patients and public health.
Disease Vectors, Surveillance, and Prevention
IDSA supports the subcommittee’s call for more research to determine effective interventions for reducing the incidence of tick-borne diseases in humans, including novel approaches to vector control, and comprehensive vector control programs that encompass both mosquitos and ticks. Vector control for ticks is not nearly as well understood as vector control for mosquitos and would greatly benefit from further study. IDSA agrees that CDC regional Centers of Excellence in Vector-borne Disease need additional funding and should be utilized and leveraged for their knowledge and expertise in these areas. We also support further studies on geographic and ecological studies on tick-borne diseases, as well as the factors that are causing changes and expansions in endemic areas. Education of at-risk populations is another important prevention strategy that should be better used in endemic areas.
We also agree with the subcommittee that additional surveillance and epidemiology are required to understand the burden of tick-borne infections, particularly as the endemic area for some disease-bearing tick species is expanding. Proper diagnosis of a tick-borne illness can be hampered if clinicians do not have access to accurate information detailing the burden of disease in their area. While the IDSA acknowledges that the CDC case definition for Lyme disease is intended for use as an epidemiological tool, it is incorrect to promulgate somehow the notion that the components of the surveillance definitions should not be used for clinical diagnosis. To further popularize such a statement would confuse clinicians from understanding that the clinical diagnosis of Lyme disease rests on the foundations of either objective clinical findings and/or laboratory testing. The language used by the subcommittee appears to have the intent of inappropriately broadening the definition of Lyme disease to include patients with only fatigue, pain or other subjective conditions. We emphasize that any new approaches for expanding surveillance of tick-borne diseases must meet rigorous, evidence-based standards to ensure accuracy.
Access to Care Services and Support to Patients
IDSA supports the subcommittee’s recommendations for increased education on the prevention of tick-borne diseases and removal of ticks. It is essential that all educational materials include only evidence-based information and do not promote over-diagnosis or misdiagnosis of Lyme disease or unsafe or ineffective treatments, including long-term antibiotic use.
IDSA supports patient access to evidence-based, medically appropriate diagnosis and treatment of Lyme disease and post-Lyme disease treatment syndrome that is safe and effective. We oppose policies that would subject patients to faulty diagnostic procedures or dangerous or unproven treatments. We also oppose recommendations or laws designed to protect clinicians who provide harmful treatments. In addition, we oppose any attempts by the working group to undermine widely accepted medical guidelines for the treatment of Lyme disease that are rooted in scientific evidence or to promote clinical guidelines that are lacking in evidence-basis.
While IDSA supports increased federal funding for research on tick-borne diseases, this funding cannot come at the expense of funding for other diseases, including HIV. Pitting one disease against another, is counter productive and costly. As has been evidenced repeatedly, we must sustain our efforts in responding to infectious diseases or risk serious and potentially deadly outbreaks, as we have already seen recently for HIV due to the opioid epidemic.
Other Tick-Borne Diseases and Co-Infections
There are many other serious and potentially fatal tick-borne diseases such as Powassan virus, babesiosis, anaplasmosis, ehrlichiosis, tularemia, Rocky Mountain Spotted Fever and other spotted fever group rickettsioses, anaplasmosis, and others. These diverse infections may present with symptoms and signs somewhat similar to early Lyme disease including fever, aches, and rashes. Some of these diseases are also expanding into new geographic areas. Thus, increased surveillance and epidemiology, as well as additional research into these diseases would be greatly beneficial. While ticks feed on animals infected with Bartonella there is no convincing evidence that it is a tick-transmitted human pathogen. The working group appears to highlight Bartonella as a known tick pathogen for humans while this is not the case. We appreciate the subcommittee’s attention to these diseases.
Pathogenesis, Transmission, and Treatment
IDSA acknowledges that some patients who are successfully treated for Lyme disease continue to suffer from persistent symptoms after treatment. Further research into the exact causes of these symptoms is vital to developing safe and effective treatments for these patients. IDSA supports additional research to discover better indicators of active Lyme disease infection to help clinicians and patients understand microbiological cure. Currently available serology inherently is not able to distinguish active versus past infections.
It is important that federal research funding be geared toward such studies that will truly enhance our understanding of Lyme disease. Conversely, there is not a pressing need for additional federally supported research on antibiotic treatment for Lyme disease. There is clear, widely accepted scientific evidence indicating that a 10-28 day course of antibiotics, depending on the stage of Lyme disease, will kill the Lyme disease bacterium in humans. Despite multiple clinical trials on this subject, there is no robust scientific evidence supporting the use of long-term antibiotic therapy in patients with Lyme disease that gains them sustained benefit either as initial therapy or prolonged treatment for long-term symptoms. Persistence of Borrelelia burgdorferi in humans should not be acknowledged as recommended in the subcommittee report while the facts are not supportive of this view. In fact, there is evidence that long-term antibiotic therapy for patients can lead to serious and life-threatening complications and can accelerate the development of antibiotic-resistant bacterial infections in patients. Patients who have been on long-term antibiotic therapy after diagnoses of chronic Lyme disease have later developed Clostridium difficile, Pseudomonas aeruginosa, Acinetobacter, and other infections. Some of these patients developed septic shock and died.
It is essential that research on tick-borne diseases meet established standards for scientific rigor to ensure that study results are meaningful and can safely and effectively guide patient care. Attempts to make clinical trials more inclusive or pragmatic must not override the need to ensure that enrolled patients have Lyme disease based on widely accepted standards. While the tick microbiome deserves further investigation, to widely popularize basic scientific information as something that clinicians should routinely understand inappropriately leaps over the required steps to understand if such pathogens are a cause of human infections.
Clinical education on the diagnosis and treatment of tick-borne diseases must continue to rely upon robust scientific evidence and should not attempt to undermine medically appropriate diagnostic practices. Except in rare cases as true with all infectious diseases, Lyme disease causes well-characterized presentations. Over-testing and over-diagnosis of Lyme disease can lead to patients who do not have Lyme disease receiving unnecessary and potentially harmful treatments. While IDSA continues to call for more research to improve diagnostic tools for Lyme disease, it is essential that clinical education is rooted in the best currently available evidence.
The subcommittee’s recommendation that peer-reviewed reports be created by clinicians and scientists that represent a wide spectrum of medical opinions on the treatment of Lyme disease is of great concern. Approximately 20 clinical and scientific organizations in North America and Europe and numerous scientific and public health bodies agree with the IDSA perspective regarding the lack of efficacy and significant danger of long-term antibiotic therapy for treating Lyme disease. Medical opinions that lack the foundation of rigorous scientific evidence should not be held in equal regard in the working group’s recommendations, and doing so would be greatly detrimental to patients and public health.
Testing and Diagnostics
IDSA greatly appreciates the subcommittee’s recommendations for increased research to improve Lyme disease diagnostics. Lyme disease is diagnosed by a combination of medical history, physical exam, and if needed, diagnostic testing. The current FDA-approved serologic tests work best for patients who have symptoms beyond the first two to four weeks as this is the typical response time for the human immune system to make antibodies against a pathogen, such as Borrelelia burgdorferi. In patients who are just infected, the diagnosis is best made if the characteristic rash, erythema migrans is present as patients are frequently seronegative. Currently, clinically-validated FDA tests are the best available tests for diagnosis of Lyme disease when the characteristic rash or history is not present. Scientific advances are needed to improve testing strategies for the earliest phases of Lyme disease.
As serologic tests may remain positive for decades after successful treatment of Lyme disease, development of a test that provides supportive evidence that a patient has been microbiologically cured of infection would be of great benefit. Particularly for a patient who has persistent symptoms after antibiotic therapy, this would assist in guiding their clinician to avoid unnecessary additional antimicrobial therapy. IDSA has long advocated for more funding and research into more accurate and specific diagnostics. Progress in this area would greatly reduce misdiagnosis and link patients to effective treatments more quickly.
Important strides have been made to support the development of new diagnostic testing procedures. The NIH and CDC initiated a Serum Reference repository in 2008 and, at the end of 2011, began making standardized Lyme disease cases with serum samples available to the scientific community on a broad basis for testing and comparison of new diagnostic tests. The repository enables comparison of newly developed and existing diagnostic tests under identical conditions using the same panel of well-characterized reference specimens. CDC is also developing next-generation direct diagnostic tests (e.g., biomarkers) to improve upon current serological tests. However, the development, validation and commercial distribution of new tests can take years and millions of dollars.
Vaccines and Therapeutics
IDSA greatly appreciates the work done by the vaccine and therapeutics subcommittee, and supports many of the recommendations made in its report. A new vaccine that is safe and effective in humans would be an excellent tool for the prevention of Lyme disease. We also appreciate the acknowledgment of the barriers to acceptance of a new Lyme disease vaccine from the public and industry perspectives and hope the working group can more explicitly detail strategies for overcoming these challenges. IDSA also believes further research into vaccines that target the disease reservoir and vector would be greatly beneficial to prevention efforts. It is unclear to IDSA why recommendations regarding a Lyme disease vaccine are not addressed by this phase of the working group. An effective vaccine would be a key to prevention and thereby critically reduce the public health threat of Lyme disease.
IDSA agrees with the subcommittee that therapeutics for symptoms that persist after Lyme disease treatment would be greatly beneficial. We support further research that would develop a better understanding of why some patients do not improve after antibiotic therapy. We also support the conclusion that the efficacy of antimicrobials for treatment of acute Lyme disease in well-defined patient populations is well documented, and add that additional long-term antibiotic treatments have not demonstrated any clinical benefits.
IDSA thanks the working group for its attention to tick-borne diseases and looks forward to the opportunity to help inform and advance evidence-based policy that will best serve the interests of patients and public health. If the working group acknowledges the need for more time to develop detailed responses, we would like the opportunity to amend this letter.
Sincerely,
Paul G. Auwaerter, MD, MBA, FIDSA
President, IDSA
Lucy Barnes
Dear Tick Borne Disease Working Group Members,
Thank you for trying to make improvements for those suffering from tick borne diseases and those who will contract these infections in the near future.
Over the past 30 years federal funding for Lyme disease research was awarded to the same small group of “researchers” who produced the list of conclusions noted on the attachment below. Each and every one of these "official findings", many still actively and strongly promoted by the IDSA and CDC, have been disproven by an overwhelming preponderance of the evidence.
However, these non-evidence based theories didn’t die a swift death as they should have. Instead they lingered on, often grew in acceptance because there were few if any rebuttals (due to lack of funding) and eventually these misnomers spread nationally and internationally causing more harm and destruction to patients world wide.
Researchers responsible for fabricating the inaccurate conclusions were not questioned or sanctioned when their studies were proven faulty. Additionally, their studies were not reviewed in depth by anyone not already positioned in their “camp”- - someone who had the desire and the power to put an end to their fraudulent work products and eliminate their wasteful spending so the limited resources could be better utilized.
On May 1, 2008, and only after a lengthy anti-trust investigation into the IDSA Lyme disease guideline authors practices, Attorney General Richard Blumenthal (CT) summed up his findings and stated in part:
"The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests -- in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies -- to exclude divergent medical evidence and opinion.” Source
Ten years after the AG’s legal findings were released, the public is still subjected to the same grossly outdated (2006) treatment guidelines and the same failed lab tests. Additionally, the authors and their supporters continue to work for and consult with insurers (hearings, court, disability) against patients and the doctors treating them; and patents on woefully inadequate tests are still producing financially for the patent holders.
The same small group of discredited researchers were still free to repeat the same basic studies that produced the same outcomes in order to support the same previously failed conclusions. And as you now know, the results have been disastrous.
Rather than these tax-payer funded agencies and researchers admitting they were wrong and/or reaching out to make corrections or positive changes to benefit those still suffering, they each have a long history of avoiding the questions and complaints and then waiting until far too much damage has been done and the outcry from the public is so great they are forced to act- to “do something”. During that time millions of innocent people have become much sicker, chronically ill and often disabled from the lack of prompt attention and appropriate treatment. Granted, sometimes people make mistakes. But, how wrong can they be and how long will this travesty and these injustices be allowed to continue unaddressed? How many more people will suffer as a result of their incompetence and self-serving actions? Enough is enough!
- Lyme is caused by a virus. WRONG! It is caused by bacteria. (More information here.)
- Lyme should not be treated with antibiotics. WRONG! Lyme is a bacterial infection which, like other bacterial infections, is susceptible to appropriate antibiotic therapy. (More information here.)
- If you continue to have Lyme symptoms after contracting Lyme disease and have been treated with the recommended (CDC, IDSA) short course of antibiotics, no additional antibiotics are necessary. WRONG! Standard antibiotic protocols have been found to be extremely unreliable in producing a cure for Lyme disease. Retreatment has been proven to considerably improve the patient's condition in many cases.
- Blood tests the IDSA, CDC and their partners developed (and patented for profit), are reliable. WRONG! The tests have been proven to miss up to 75% of people who are infected. (More information here.)
- There are many false-positive test results. WRONG! There are an extraordinary amount of false-negative test results.
- Lyme disease is easy to diagnose and cure. WRONG! Lyme disease (http:Medscape.com/viewarticle/586226) can mimic countless medical conditions and a cure has never been developed.
- Reporting practices are sufficient and give us a good picture of the spread of Lyme disease. WRONG! The actual numbers of Lyme cases is over 10 times what is currently reported.
- After treatment people do not have Lyme, just the "aches and pains" (https://sites.google.com/site/idsaonlyme/guidelines/2oo6-guidelines ) of daily living. WRONG! Countless people have become chronically ill, disabled and many have died.
- There is no evidence chronic Lyme exists. WRONG! There are over 1,000 scientific studies proving it does exist, and millions of people suffering from symptoms of chronic Lyme disease (https://sites.google.com/site/marylandlyme/chronic-lyme-disease/definition-of-chronic-lyme-disease).
- The federally supported IDSA Lyme Disease Guidelines represent the best of the science. WRONG! They were found to be developed by a handful of people with conflicts of interest and are not successful in producing a cure for the majority of people.
- Lyme disease can not be passed from mother to fetus. WRONG! A plethora of scientific literature (https://sites.google.com/site/marylandlyme/congenital-transmission) indicates simple complications to still births and infant death are possible.
- There is no Lyme here in -fill in the blank with your State’s name- so you can't have Lyme disease. WRONG! Absence of evidence isn’t proof of anything. Lyme disease has been documented (https://academic.oup.com/jme/article-abstract/38/4/493/861903?redirectedFrom=fulltext) in all 50 states and 80 different countries.
- Said the authors of the IDSA Lyme guidelines- We have no conflicts of interest. WRONG! May 1, 2008- The CT Attorney General’s investigation proved otherwise.
- A tick must be attached for 48 hours to transmit Lyme disease. WRONG! Studies prove otherwise and transmission can occur in less than a few hours.
- Two pills of Doxycycline when fist bitten will prevent/cure Lyme disease. WRONG! Lyme disease can disseminate throughout the body within hours and multiple studies have proven this claim is absolutely not true.
- We care about sick patients and want to work with doctors to help them. WRONG! You just need to ask anyone who was denied treatment and developed the late chronic stages of Lyme disease what they think. Or you can read the ugly attacks on sick patients and their doctors that are published in journals.
- The standard 2-3 wee)ks of Doxycycline protocol cures most cases of Lyme disease. WRONG! Thousands of studies, and thousands of sick patients prove otherwise.
- You can not have more than one tick borne disease at a time. WRONG! People can be multiply infected with a number of various organisms.
- The new vaccine is safe and effective. WRONG! It was pulled from the market after reports of injury (https://sites.google.com/site/lymevaccine/home) began rising and law suits were filed by those who were injured.
- Lyme disease can not be sexually transmitted. WRONG! Multiple studies (https://sites.google.com/site/virginialyme/sexual) found spirochetes in secretions from both men and women.
- Only certain ticks carry certain diseases. WRONG! Each year more discoveries are made proving that theory wrong. (https://www.lymedisease.org/lyme-south-lone-star/).
- Steroids are a viable treatment for those with Lyme disease. WRONG! Steroids are contraindicated (http://www.chroniclymedisease.com/burrascano_lyme_treatment_guidelines) for all but the most severe complications.
- Some exercise, visits to psychiatrists and Advil are all that are needed if symptoms remain or become worse after treatment. WRONG! Co-infections and other sources for the symptoms need to be explored.
- Prevention efforts are working. WRONG! Federally funded studies and an exploding number of cases prove otherwise.
- Blood donations can be safely made by people treated for Lyme disease. WRONG! The Red Cross and others researchers have proven spirochetes can remain active (https://sites.google.com/site/marylandlyme/tick-borne-diseases/red-cross-trans) even through the harsh blood storage conditions.
- Doxycycline is the most effective treatment for Lyme disease. WRONG! Doxycycline is limited in its ability to kill Lyme disease organisms. There are at least 165 different FDA approved medications (https://sites.google.com/site/marylandlyme/johns-hopkins/hopkins--finally-sees-the-light) already on the market proven to be more effective.
- There is no such thing as CHRONIC Lyme disease because it has never been defined. WRONG! It's OFFICIAL (https://sites.google.com/site/marylandlyme/chronic-lyme-disease/definition-of-chronic-lyme-disease) and the documentation is overwhelming.
- Lyme rashes (erythema migrans) must be larger than 5 cm (or 1.9685 inches) for a "secure diagnosis". WRONG! Lyme rashes have been documented in the scientific literature as being 1 cm (or 0.394 inches) in diameter.
To address the above situation, I respectfully request the following actions be taken:
- A strong recommendation to HHS and others by the TBD Working Group for the transfer or dismissal of those previously or currently involved in any federal TBD funded research, including and especially the 2000 and 2006 IDSA Lyme disease guideline authors and any of their co-authors on Lyme and tick borne disease studies. This action is absolutely necessary due to the disastrous way research, education, funding and patient care has been handled for the past three decades by a select few.
- TBD Working Group members or independent appointees should engage in strict oversight and monitoring of federal agencies involved in any Lyme disease policies, research and budgets related to TBD. This will help ensure the rogue few and federal agencies will discontinue abusing a system originally created to provide quality research findings and solid solutions to problems faced by millions of people both nationally and world wide.
- All future TBD and antibiotic related research grants be patient oriented, closely monitored and approved by all TBD Working Group members before funds are released.
- Designate that the majority of government funding for TBD related research be awarded to independent scientific researchers and experienced medical professionals with a history of successfully treating patients with early, late-stage and chronic Lyme and tick borne diseases.
- Designate the majority of new funding be directed to finding a cure rather than continuing the focus on stake holder’s money making schemes (patents, vaccines, prevention products, etc.)
Once these measures are secure and fully implemented we can all move forward having faith that a much needed change will take place- one that is absolutely necessary before we can find a cure for Lyme and many other tick borne diseases. Thank you in advance for your efforts in addressing these sincere concerns
Lucy Barnes, Director
Lyme Disease Education & Support Groups of Maryland
www.MarylandLyme.org
Leslie Brown
Dear Sirs and Madams,
I have been following the meetings of the new Tick Borne Disease Working Group with great anticipation. I battled Lyme and co-infections myself for ten years, I lived the nightmare that many thousands of other have and still are. I am left totally disabled as a result. I figure I have a dog in this fight.
Following the recent meeting was quite encouraging. It appears that the goals are very positive and heading in the right direction and the committee members are agreeing on the topics. This is really heartening to observe.
I wanted to bring up a topic that I didn’t see addressed during the meeting or in the reports, one that I found during my journey to be significant to patient recovery. That is the effect of the well known Herxheimer Reaction to Lyme treatment.
While I was going through treatment I searched out various means of support; online groups, local support groups, other patients in the waiting room, etc. From my own experience with the Herxheimer Reaction I was very aware of how physically crippling and horrendously painful it is during treatment. I am strong willed and I was determined to beat these bugs so I pushed through the herx in my goal to wellness. But I found that many others couldn’t. They could not handle that extreme level of horrible illness, and they would stop or reduce their treatment to alleviate the herxes. Many turned to alternative natural treatment therapies, but never really got better, they got to a livable level of health. I felt terrible for them, wishing they had the strength to fight for what they deserved. I think many of these people are still fighting chronic Lyme and always will.
If this topic were addressed in this venue it would probably go a long way towards helping many Lyme sufferers, as are all of the other topics being addressed.
Thank you for all of you effort and determination to address this long overdue battle.
Regards,
Leslie Brown
Enrico Bruzzese
Thank you for your service and for this opportunity to stand in front of you today. My name is Enrico Bruzzese. I am a Registered Respiratory Therapist with the NYC Health and Hospitals Corporation at Jacobi Medical Center. My wife Josephine and I along with our four children, James 21, Adam 16, Julia 14, and Sofia 9 all suffer from Lyme and tick-borne disease, as well as carry the burden of being caregivers to my sickest child.
The nuances of Lyme disease would not have come to fruition for me if not for my sickest daughter Julia. Doctors were eager to set us on a path of disparity, A doctor from the CDC personally called me to discourage me from following a Lyme disease treatment path. Another doctor of the ALDF wrote a 10 page paper defaming Julia and my entire family for following a Lyme disease treatment path. I was having a hard time believing what I was seeing.
My whole family has seen tremendous improvement on treatment. Julia has seen major improvement under her current doctor’s care. I do not have mainstream doctors to thank for their improvement, but for Julia and all of her suffering for opening my eyes to Lyme disease and for the knowledge that I needed to save my family.
In September 2013 we discovered an insect bite accompanied by a bullseye rash on Julia at my family’s NY Catskill Mountains home, an endemic area for Lyme. In the subsequent two years, Julia was constantly at the pediatricians with unexplained fevers, body aches, exhaustion, and vision difficulties—to name a few.
In May of 2015 Julia fell acutely ill losing her ability to walk. In the subsequent 6 weeks I was frantically seeking medical care for Julia and we saw over 70 doctors, the majority insisted that Julia was faking her symptoms and had us believe that her suffering was psychological in nature. Others would just shrug their shoulders.
After realizing Lyme disease, over 35 doctors in the subsequent three months insisted that seronegative Lyme disease was an impossibility, and instead argued that it made more sense Julia was faking her symptoms, even suggested using truth serum!!; fever, hair loss, chest pain, drenching day and night sweats, air hunger, stretch marks, tremors, twitching, cyanosis, tachycardia, hypotension, vision loss, sensory deficit, flaccid paralysis, and more; doctors missed these hallmark signs of Babesia, Bartonella, POTS, Lyme, and Tularemia, some would even mimic Julia's eyes and facial twitching to show that is was possible to fake.
We must hold doctors to higher standards.
Because I couldn't find help, I abandoned my livelihood to provide around-the-clock care for my daughter and eventually the rest of my children.
SOCIETY NEEDS YOUR HELP!!
"There can be no keener revelation of a society's soul than the way in which it treats its children" - Nelson Mandela
Josephine Bruzesse
I couldn’t make the steps. My legs were weak and painful. What was I going to do? It was New Year ’s Day and I was having 22 people over for dinner. Coming up from my basement with food in my hands, I called out to my 76 year old mother in law for help.
My name is Josephine Bruzzese. I am a mother of four beautiful children. James 21, Adam 16, Julia 14, and Sofia 9. We all suffer from Lyme disease and tick born infections. I’m here today to share with you our tragedies and our blessings. I hope with your help we can ensure others don’t suffer all my family has and continues to suffer.
I took my daughter Julia to her pediatrician in September 2013 with a bull eye rash. Not knowing anything about tick bites we didn’t know what it was. The pediatrician said it was just a bad mosquito bite, and if it doesn’t go away follow up with a dermatologist. Trusting the Doctor, I believed her. The rash did go away and that was the end of it, or so we thought. The following year and half we saw Julia suffer migrating joint pain, fevers, exhaustion, loss of hair, and loss of vision. She went from visiting her pediatrician twice a year to monthly. Yet the pediatrician didn’t see anything wrong with this. May of 2015, Julia lost her ability to walk. Our horror story began. She was barely conscious and was paralyzed. We went from hospital to hospital trying to figure out what was happening to our daughter. After not finding answers, doctors would tell us it was all in her head. We agreed to have her evaluated by physiatrists several times. She was cleared. I witnessed a therapist drop her to see if she would save herself from falling and he caught her head just as she was about to hit the floor. They would come in the middle of the night when Julia would be sleeping and prick her feet so hard she would bleed to see if she felt it. She never did. After my husbands extensive research he knew this was Lyme. The Doctors wouldn't listen. My husband found a NP who accepted insurance. She began to treat Julia for Lyme and Julia immediately began to feel better, but it was limited. The Lyme Doctors didn't take insurance and we couldn't afford it. Then our blessings began. Julia was blessed by Pope Francis. Through that blessing she received the support of our community and people all over the world. After the blessing Julia became committed to raise awareness and help others with this terrible disease. We have people reaching out to us to tell us that Julia saved their lives. Julia saved mine. If it wasn't for the knowledge we have learned from her suffering, I would have been diagnosed with MS.
I'm here today to ask you to please help us save lives. Mother Teresa once said,”Yesterday is gone, Tomorrow has not yet come. We only have today. Let us begin."
James Bruzzese
Fate is a fickle thing. When my sister first fell ill, she told my father, “Dad, don’t worry. Everything happens for a reason.” She said this from a hospital bed, half conscious and paralyzed from the neck down. The attending pediatrician had just finished telling her that this might all be in her head, and then had asked my father if he’d like another psych consult. It was a hard day. My sister’s statement had annoyed me because what good reason could there be for this to happen to an 11-year-old child.
Now, however, I understand the wisdom of that comment. Fate, destiny, God, whatever you want to call it, it chooses us for a mission; when a physical therapist purposely dropped my sister to the floor on orders of an attending pediatrician to rule out malingering, it made my mission, my family’s mission very clear.
My name is James Bruzzese and I am an accelerated medical student from the Sophie Davis School of Biomedical Education/CUNY School of Medicine. We all have spoken about education; however, the conversation has focused on educating people who are already doctors. I believe the root of the problem lies within medical schools. I have witnessed professors teaching outdated guidelines that are no longer accepted on the National Guidelines Clearinghouse. I have witnessed them teach science about Lyme that even the CDC admits being inaccurate. Medical students are being taught that diagnosis for Lyme disease is based solely on laboratory testing instead of clinical findings.
My sister went undiagnosed for 2 years because a pediatrician disregarded a bull eye’s rash. Then again, the most prestigious hospitals in New York City disregarded a documented history of a bull’s eye rash, saying all symptoms were attributable to a psychological disorder. They never told us that drenching night sweats, day sweats, chills and easy bruising were characteristic of babesia; they never told us that migratory joint and muscle pain with a history of a bull’s eye rash was a staple of Lyme disease. And why? Because this is not what is taught in medical school. Babesia, Lyme disease, are not on the list of possible differentials when the patient presents with the aforementioned symptoms. Instead, they teach juvenile arthritis for cases such as these, and they warn, be careful, this can look like Lyme but it’s not!
You know, Hippocrates spoke about two sides of medicine: science and opinion. He says the former begets knowledge, but the latter begets ignorance. We need to be teaching our future doctors science, not opinion. And if the science is not sound and there are two sides of a disagreement, medical students need to be aware of both sides.
I’d like to leave you with this. Success is not in the result of effort; success is in the effort to succeed. Proper effort towards beneficence will breed success. Samuel L. Jackson describes this committee well in the Avenger’s movie. He says, “There was an idea to bring together a group of remarkable people so that when they needed you to, you could fight the battles they never could. You are that group of people; you are the heroes we have chosen. Save us. Seize today, so that tomorrow can be a better one, thank you.
Adam Bruzzese
I wouldn’t accept it. I wouldn't accept the horrors of the sight I have come to know as normal: my dying sister in front of me, her body cold, her face pale, her breathing slow and reluctant, her once loving eyes blank and lifeless. My father would hold her, tears creeping down his over-exhausted face, refusing to let go, refusing to evade his eyes away from her struggling chest, as with every one of her slight breaths came momentous relief in each one of our severed hearts.
I have witnessed the people I love the most, the people I hold most dear, the people who I have confidently placed my trust in throughout my whole life, fall at the hands of something they cannot see, forced to endure unbearable burdens, crumble to pieces, and sacrifice their lives at the hands of an abhorrent, seemingly unstoppable force. This is a force that has taken the life away from my family, the ability to function from my sister, and the quality of health from millions of individuals. It is ruthless in its disarray, taking away everything that once seemed to be immovable, within the blink of an eye. This horror is Lyme disease, a name so deeply engraved into our minds as a constant obstacle to a normal life, or any life at all.
My name is Adam Bruzzese and I have Lyme Disease. If not for Julia, I would have rotted for years on end, continuously progressing into debilitation, probably acquiring the label of lazy or inadequate. It is solely due to my sister’s suffering, and my family’s frantic persistence in approaching her suffering, that my siblings and I are functional.
Despite Julia’s fatal conditions, despite her very real tragic symptoms, mainstream doctors would approach us in speculation, with an wise smirk, either shrugging their shoulders, or manhandling my sister in attempt to wake her limp corpse. They would drop her purposely, stab her with toothpicks, and arrive with armies of doctors all in an attempt to aggressively force their ungrounded theories, some claiming that this unconscious, paralyzed 11 year old girl was faking an illness in the middle of the summer. They would criminalize the family present, only allowing for their thought and dismissing anything else at the moment it was mentioned. Julia’s illness was half the battle; the other half was the criminalization and controversy of mainstream medicine surrounding Lyme disease.
I can't show you how we suffered, but I can show you that we have not become complacent to it. We have not submitted to the horrors of a disease, and we have not let it form identities that do not define who we have truly are. To close, I quote Martin Luther King Jr.: “Our lives begin to end the day we become silent about things that matter
Julia Bruzzese
I used to love to dance and play sports; I used to love bike rides and nights swims with my best friends. I took pride in my straight As and my seat as vice president in student body. I miss those things so much. Today? I just… dream of taking a step.
Morning blessings to you all. My name is Julia Bruzzese, and I am 14 years old. When I was nine years old I had a tick bite with a bullseye rash. My pediatrician was not concerned and sent me home. After that tick bite, I experienced exhaustion, vision difficulties, body aches, weakness, and frequent fevers. I suffered silently for the next two years and my pediatrician blamed it on growing pains and viruses. Then suddenly, I fell acutely ill and lost my ability to walk. I found myself in hospital beds, paralyzed and unconscious. After testing negative to extensive serological workups, doctors would insist it was all in my head.
I was comatose, losing my hair, unable to move, suffering high fevers, night and day sweats, chills and shaking, and difficulty breathing. We were abandoned by doctors, hospitals, and insurance companies. That July, thank to my dad’s research and perseverance to find an answer, I was clinically diagnosed with Lyme disease, bartonella, and babesias. After a week of treatment, I had regained my mental status and was able to feel my toes. I had now tested positive for Lyme and other co-infections, but I was getting worse after my Lyme specialist could not treat me further. Nonetheless, after suddenly getting blessed by Pope Francis and receiving major media coverage and an outpouring of love and support from around the world, I was able to get treatment and see a Lyme specialist with the money raised by my community. Once again, due to my dad’s persistence, I was able to see Dr. Richard Horrowitz. He treated my bartonella, babesias, co infections, and is the first doctor to ever treat me for POTS. Suddenly my day and night sweats, high fevers, difficulty breathing, and other symptoms that had me bedridden were almost gone. I was seeing more improvement than I had ever seen, and still am; and for the first time in a while, I had hope.
You see, my story is just one of so many. Millions suffer in silence from this horrible disease. It is unfair. This disease has stolen my childhood and my life.
Fortunately, I had the world behind me; I had my family, my saving grace. Most don’t have others to support them and be a light for them when they are trying to see in the dark. So today I come here and sit from my wheelchair in front of you all to be a light to those people, to be there voice. I believe in my heart that this working group can make a much-needed change. So please open your eyes and hear our calls for help. Be our light, our guide. We need you. It is time to take action. Thank you and God bless you all.
Sofia Bruzesse
Good Morning Everyone!
My name is Sofia Bruzzese, I am 9-years-old, I go to St. Bernadette Catholic Academy. At St. Bernadette Catholic Academy we learn how to respect, care, and help one another. I have Lyme disease, but I’m much better now! I use to dance with my sister all the time, but then we couldn’t anymore; because she couldn’t walk! Every night I prayed for her to walk again, I prayed that Julia can just dance with me one more time. I also pray that you can make a change for families that have Lyme disease. Not only for families, but for people who are alone and have no one to pray for them or guide them through their sickness. So please! Help my sister! Help my family! But most of all, help those who are in need of care!!
Thank you so much for your time today!
I wish you all a wonderful and productive day!
May God bless each and every one of you!
Wendy Buckingham
My name is Wendy Buckingham. I live in the small little town of Chiloquin, in southern Oregon. I am writing on behalf of myself and my 16-year-old daughter.
I've had asthma and eczema since I was 18 months old along with many environmental and animal allergies. When I was about 5, my primary family physician would no longer see me because of my skin condition. Long story short, I've spent most of my life getting short doses of antibiotics to control infections in my skin, at least 2 times each year. I truly believe that is what kept me somewhat healthy. Completely by accident, I was about to find out that I am positive for Bartonella Henselae "cat scratch fever". This was on March 21, 2018. In trying to figure out when I may have been tick bitten or cat scratched - it appears it was 30 years ago, between my Junior and Senior rear in High School. This was before there was even a test for it, back in 1988. I am so thankful that my Naturopathic Physician, in Klamath Falls, heard my complaints and just said "let's do a Lyme test on you." Without this positive Bartonella result, I feel we would still be chasing our tails trying to figure out what is wrong with our daughter.
Due to the arrogance of the "Medical Doctors", not listening to a mother's gut instinct and forcing us to waste precious time jumping through unnecessary hoops to check all of the boxes (on your own), we would probably never have figured out what is wrong with our daughter. For this, I am disgusted and outraged at the lack of concern that was shown to my daughter!
Her story starts about 15 months ago, or so. She started to complain about anxiety and panic type attacks. That gradually turned into her heart racing and skipping around and really scaring her and us to the point that we went to the local ER, only to be told that she had a UTI. Through their testing for her complaint, they ran and EKG, and found no irregularities. They send her home with some antibiotics. Her symptoms persisted, and we wound up getting a couple more EKGs and a 24 hour halter monitor. At one point, she got a stomach x-ray that showed she was severely constipated, so she was told to take Myralax. We were then referred to a Pediatric Heart Specialist, in Bend, Oregon. She was able to perform an Echo Cardiogram, which showed that structurally, everything was perfectly healthy. We were sent home with a 14 day heart monitor, which also showed no abnormality. We didn't know what to think, so thankful that she was visually, physically healthy, but internally there was something off. As we look back now, this could be a direct symptom of Lyme disease and/or co-infections.
About 4 months had passed and she started having issues with stomach pain. It would come and go. She is a picky eater and has a pretty unhealthy diet because of it. We thought this had to be the cause of her discomfort.
In June of 2017, she asked if she could start going to therapy. She started going and in November, her therapist called me in at the end of a session and told me that "we've crossed a line, she is talking of harming herself". So the whirlwind began. We were off to the family medical doctor, to get prescription antidepressants. While there, she mentioned her stomach pain. She was given a blood test to check for thyroid issues and Celiac disease, all of which came back negative. Again, this could be a direct symptom of Lyme disease and/or co-infections, that we are now treating incorrectly.
She had to go back to our family medical doctor for a medication check on her antidepressant in December, and again in January. Each time, complaining about her stomach pain. Each time, diet changes and exercise were discussed. In January, our family doctor suggested an ultrasound (but wasn't exactly wanting to do one herself), or she could refer us to a Gastroenterologist. We chose the Gastroenterologist. (This appointment finally happened on 4/13/18.)
On February 22, 2018, we were certain that she was experiencing an appendicitis. We took her to the ER again (almost one year to the day from our 1st visit). We went through the blood tests, urine tests and finally got the ok for a CT scan. Again, the results showed nothing in her blood or urine. The CT scan showed she may have had an ovarian cyst on the right ovary, and there was a small amount of free fluid. She was told that within 48 hours, her pain should ease up and go away. What the report said, that NO ONE bothered to tell us was that she also had a small 4mm "spot" on her liver, but it is insignificant in a 15 year old girl. WHAT? Why wasn't this discussed? If she is in such pain, this might actually be significant in a 15 year old girl!! Again, this could be a direct symptom of Lyme disease and/or co-infections.
We are now into April. We follow up with our family medical doctor, again. It is also the time for a medication check as well. She says her antidepressant is no longer working as it was a couple of months ago. We get a new prescription for a different type. She continues to complain about this persistent lower abdominal pain, between her belly button and her ovary that has not gone away, but actually gotten worse. She was at a pretty consistent level 6 out of 10 on the pain scale. She had begun to walk with a limp. By now, I had gotten my results and through hours and hours of research, I am concerned that I may have transferred the infection in utero. I explained my concerns and I ask the family medical doctor if they do Lyme blood testing at the clinic. She told me "we can, but we will have to send it out." She followed that with "Lyme is a really big issue on the East Coast, but it's not really a West Coast thing." (I'm not sure that she picked up on the fact that I just told her that I have a co-infection of Lyme - Bartonella Henselae!!!) She got up, left the room and scheduled another medication check for the end of April. At this point, she was too ill to go to, so we rescheduled for May 3rd.
On April 6th, she had an appointment with an OBGYN, in Medford, Oregon. He was a little more open to the idea of Lyme or Bartonella, but would "need to do some research" and only after making sure it wasn't anything else. In the meantime, he did an abdominal ultrasound and found no irregularities, no fluid, no cysts and noting looking like endometriosis. He wanted us to have a "better" ultrasound at our local hospital's Radiology department. The results of this were the same as all of the others, nothing irregular, no cysts, no fluid, no endometriosis. She was placed on a low hormone birth control, in hopes to alleviate some of the pain. Again, this could be a direct symptom of Lyme disease and/or co-infections, that we are now treating incorrectly.
On April 13th, we finally got in to see a Pediatric Gastroenterologist from OSHU in Portland. This specialist medical doctor makes a couple of trips a month to Medford, Oregon and that is where we went. She examined her abdomen, doing the usual palpations. After I explained that I had just been diagnosed with Bartonella Henselae and my concerns with transferring it to her in utero, she poo-pooed my idea. She wanted her to get a blood test for vitamin D deficiency and prescribed Myralax to use, even though she was not constipated. She discussed diet and exercise and said "come back in 4 months". Again, this could be a direct symptom of Lyme disease and/or co-infections, that we are now treating incorrectly.
In the meantime, I was able to get her in to my Naturopathic physician, just for the Lyme blood workup. This was sent off to New Jersey. We got the results back on May 3rd. She was CDC positive for Lyme!! Her very own Lyme, not Bartonella! It is an active infection that probably happened within the past year or so. We were so relieved to finally have an answer! We know it is going to be a long hard road, but at least we have a road! We are hopeful that we are finally on the right path.
She has missed all but 2 days of school since March 19, 2018. She currently has to walk with assistance of a person, a walker or wheelchair. She has some cognitive symptoms, like memory and processing. She also suffers from not being able to focus well enough to read or draw, for which she is very gifted. She has a beautiful voice and no longer sings. She has numbness in her finger joints and stiffness in her neck. She is now at a constant 8 out of 10 for pain with episodes of "stabbing" pains that go from the front of her lower abdominal area straight to her back. Given these symptoms, it is likely she does actually have Bartonella and possibly even Babesia. We are in the process of going to a highly recommended Naturopathic Physician in Corvallis, Oregon that has years and years of experience with Lyme disease and treatment. Currently, she is only taking 2 months of 200 mg of doxycycline and some supplements. So far, she has had no relief. The saddest thing she told me was "I just want to be 16"! I want that for her too.
It would also be nice to be allowed access to some sort of respite care or temporary disability benefits as to help cover her care and costs! I haven't yet delved into this portion of this nightmare, but when I get some rest, I surely will be advocating from all angles of this nasty disease.
Thank you for your time!
Jennifer Burton
It was a privilege to speak at the 2/12/18 meeting. I spoke about some of the GAPS regarding Tick Borne Illnesses and my tick borne illness, Alpha Gal Syndrome; about my symptoms: extreme fatigue, joint pain, rashes, vomiting, diarrhea, GI distress & bloating, angioedema, urticaria, and 4 anaphylactic episodes, 2 nearly fatal.1 On Thursday, 5/10/18, I monitored the TBDWG day-long meeting and once again I’d like to address some of the GAPS reported on. As much as I’d like to thank the various SubCommittees for addressing known GAPS, it also truly saddens me that most of the SubCommittees, not all, focused only on and addressed only Lyme Disease and ‘passed off’ all of the ‘Other Tick Borne Diseases’ to that SubCommittee. My hopes were the name of the Committee as a whole - Tick Borne Disease Working Group – would mean EVERY SubCommittee would take an overall view of ALL Tick Borne Diseases (and illnesses) when investigating and reporting on their specific areas of expertise. As stated on the HHS TBDWG website, “Tick-borne diseases are a serious public health problem. Lyme disease is the most common tick-borne disease, but there are at least 20 different infections 2 that are transmitted by ticks in the United States.”, not counting Tick Paralysis and Alpha Gal Syndrome (AGS). I have a neighbor and several friends that struggle and suffer through Lyme daily, but I also have friends that have been deathly ill, fighting for months and/or years from other TBDs like RMSF, Ehrlichiosis, etc. People die from ‘other’ tick borne illnesses too.3,4 I charge ALL of the SubCommittees, their obligation and duty is to review and address ALL TBD illnesses overall, including AGS and Tick Paralysis in their research, considerations and reports remembering the committee they serve is the Tick Borne Disease Working Group. If ignored, that alone is a big GAP in the committee’s charge as a whole.
GAP: Better awareness, education and resources for the medical industry regarding ALL of the 20+ recognized tick borne diseases and illnesses. I’m pleased most of the SubCommittees addressed this GAP and I want to emphasize just HOW important it is. I’d like to add, not just for physicians but ALSO for State Health Services awareness and reporting. Once again, I stress - not JUST for Lyme disease, and the outdated panel tests, but for ALL tick borne diseases. For some unknown reason, at least in Arkansas, our State Health Services and vast majority of our physicians seem to either ignore or be in total denial and refuse to test for and/or report positive tick borne diseases – especially and including Lyme disease, even when patients request to be tested. Many are forced to go out of state seeking out doctors who will run tick panels. 43% of those with AGS are self-diagnosed, because doctors consider it too rare. All too many times sick and frustrated patients say their doctor told them (and not just here in AR) ‘we don’t have tick diseases in …’ or ‘we don’t have RMSF or Lyme disease here’ or ‘That’s so rare (especially with AGS) that can’t be the problem’. One issue specific to AGS is, all too often doctors simply tell their patients just to avoid eating mammal meat or just beef and pork. The doctors have no understanding it goes MUCH further, as we also need to avoid other foods, products, medications and vaccines that contain mammal by-products and gelatin.5,6,7,8,9,10,11 Consider the AGS patients possible reactions to surgical procedures, implants, drugs and sutures. It’s a nightmare. Overall many doctors simply don’t seem recognize TBD symptoms to even consider testing for them. After suffering months or years with long term illnesses and various non tick disease related treatments, many may FINALLY be diagnosed with a TBD or multiple TBDs resulting in antibiotic treatments of 3, 6 to 9 months or even a year of intravenous antibiotics that destroy overall health and recovery. Physicians AND state health officials MUST be better educated as to the public risks and dangers of not quickly recognizing the symptoms, properly testing, diagnosing, treating, tracking and reporting ALL tick borne illnesses.
GAP: Better awareness, education and resources for first responders, paramedic and emergency room personnel, ESPECIALLY in AGS angioedema, urticaria anaphylactic related cases. We’re finding the majority of those emergency service personnel have never even heard of Alpha Gal Syndrome. Even if they read our medical tags, they have no idea if the intravenous drugs they may be administering contain mammal by products that may worsen our condition. I reiterate what I said during the 2/12/18 meeting, many of us have nearly died from improper treatment due to the lack of AGS knowledge, improper diagnosis, and drugs that were administered that contain mammalian by-products, especially gelatin.5,6,7,8,9,10,11 I charge the obligation of the Vaccine and Therapeutics SubCommittee to focus not only on developing a Lyme vaccine, but to also address the many medications and vaccines that AGS patients are unable to use due to containing mammal by-products. I also charge the Access to Care Services and Support to Patients SubCommittee to focus on educating the medical industry as a whole to recognize possible TBD symptoms and Alpha Gal Syndrome reactions in regard to the angioedema, urticaria and anaphylaxis associated with AGS for quick, proper diagnosis and treatment instead of jeopardizing all our lives and overall health from misdiagnoses.
GAP: Awareness, education and resources for pharmacists, drug and supplement manufactures. Similar to emergency services personnel, the majority of them have never heard of AGS, understand or believe the reactions many of us have to medications and vaccines that contain mammal by-products and gelatin capsules. 5,6,7,8,9,10,11 Benadryl, and majority of other allergy medications most of us used to use to relieve the AGS allergic reactions, itching, hives, etc. contain magnesium stearate, gelatin capsules, lactose, etc., all of which is mammal sourced. (Approximately 50% of AGS patients react to dairy products and ingredients such as lactose, whey, etc.) The Pharmacy Times article “Alpha-Gal (Mammalian Meat) Allergy: Implications for Pharmacists” states, “Pharmacists should be cognizant of patients presenting with anaphylaxis symptom, with a history of exposure to ticks …”. There is also a reference to “Resources for pharmacists include the Alpha-Gal Allergy Awareness Web site (www.alpha-gal.org). The Robert Wood Johnson University Hospital drug information service database is available for use by pharmacists by calling 732-937-8842.” 11 In combination with accurate and FULL disclosure of ingredients labeling, a ‘drug ingredients information service database’ could and should be developed for online public access to patients, physicians, emergency services personnel and pharmacists.
GAP: Insurance and prescription coverage. I was glad to hear this one of the areas discussed as a big GAP for patients. A vast majority of diagnostic tests, treatments and care are not covered by insurance when it comes to TBDs and illnesses. Personally I just had my annual IgE blood tests run to see if the course of actions over the past year have resulted in lowering my IgE levels. Thankfully they have all lowered by 60 to 70%, however that just means I’ve come down from a high Class 5 to a mid Class 3 range. I go back in another year. That being said, I just received an Explanation of Benefits notice denying my insurance claim for those tests, stating the reason as “Experimental & Investigative Services”. The $366 is to out-of-pocket expenses and will not be credited towards my deductible. Needless to say, I will request an appeal (again this year). My point is, these and any other services, treatment, blood tests for any and all TBDs whether for treatment and/or diagnostic purposes should be covered by our health insurance companies. We already pay exorbitant premiums and deductibles. Testing, diagnostics and treatment for TBDs need to be affordable. As you are all too aware of, that isn’t happening and the out-of-pocket costs become prohibitive for those who fight daily with the symptoms and reactions caused by TBDs. The majority of us who have AGS carry 2 Epi pens, whose costs are not only prohibitive, but now there is also a shortage here in the US, just as in Canada and the UK. I’ve been waiting over a month for my pharmacy to fill my prescription and have been told they are on backorder.
GAP: There is a huge GAP in Surveillance, Eradication, State reporting of ticks, as well as tick borne diseases. As I mentioned earlier, for some unknown reason, at least in Arkansas, AR State Health Services seems to either ignore or be in total denial and refuse to report positive tick borne diseases – especially and including Lyme disease. According to the Arkansas Dept of Health and the Univ of AR, Research & Extension, there are 5 ticks: the American Dog tick, Black-legged (deer) tick, Brown Dog tick, Gulf Coast tick, and the Lone Star tick found in Arkansas that carry the following tick borne diseases and illnesses: Rocky Mountain Spotted Fever, Ehrlichiosis, Tularemia, Anaplasmosis, Lyme Disease, STARI, Rickettsia, Alpha Gal, Heartland Virus, Tick Paralysis and Bourbon Virus. Despite that information, tick borne diseases are under diagnosed, under reported and simply denied possible here in Arkansas. It’s as if there is an invisible state borderline ticks must be afraid to cross. The estimated number of cases of AGS alone in Arkansas is 4,000, and that’s not taking any of the other well-known TBDs in Arkansas into consideration. A lot of people in our state are or have been treated for multiple TBDs. I was VERY pleased to hear at least 2 of the SubCommittees reference the new TickTracker app. I’ve already used it twice to report ticks since installing it about a month ago. It’s easy to use and has a lot of useful information. One of our members thought they should add the various TBDs and illnesses each species tick is known to carry. What is needed now is a media push to make the public aware it is available and to use it for tracking and surveillance. Since the vast majority of ticks I’ve seen and/or been bitten by are Lone Star ticks in various stages of development, I have a special interest in the Lone Star tick. Besides being linked to Alpha Gal Syndrome they are known to cause Ehrlichiosis, Tularemia, STARI and Rickettisia. A recent article, “Ticking Meatmares - Lone Star ticks hunt in packs and spread an allergy to beef and pork.”12, addresses just how differently Lone Star ticks ‘hunt’ compared to other species. It’s described as, “Lone stars, on the other hand, hunt in packs and travel at surprising speeds, emerging from the leaf litter like a swarm of thirsty, galloping lentils.” I’ve referenced a link below that is a perfect example of that very description. The 42 second video13 was taken on 5/11/18 on a bike trail here in Rogers, AR and was posted on Facebook. It shows a swarm of literally hundreds of primarily adult Lone Star ticks, easily recognizable by the numbers of white dots. The thought of hiking in the woods and stepping into that army of ticks is horrifying. Something simply has to be done not just to track, but to eradicate ticks safely without harming other useful and needed insects such as bees.
GAP: As noted by some of the SubCommittees, accurate and FULL disclosure of all ingredients in food, drug and supplement labeling. For example: ‘Natural Flavorings or Spices’ which could contain mammal sourced ingredients. This alone will allow millions with other food allergies and those of us who react to trace mammalian sources, the ability to avoid it. Foods are now being labeled with DF/Dairy Free, or GF/Gluten Free or carry the V symbol for Vegan. If the product is free of mammal sources, perhaps they could be labeled MF.
GAP: Again, as noted by some of the SubCommittees, Public Awareness is paramount. The Alpha Gal Encouragers – NW Arkansas is a support and advocacy group reaching out to each other and the Community to educate them and make them aware of Alpha Gal Syndrome and other TBDs. If a small, grass-roots Alpha Gal support and advocacy group can successfully accomplish Public Awareness in the Local and National News,14,15,16,17 imagine what our government can do with mass media publishing of information and links to information. The KEYS are Education, Awareness and Prevention. Not only in the medical field, but throughout the general public. Without those KEYS the number of people afflicted with tick borne illnesses and deaths, will only increase exponentially, just as ticks and the pathogens they carry have. Thank you in advance for your time and attention.
References
1 “TBDWG February 12, 2018 - Verbal Comment Transcript” https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/2018-02-12/verbal-comment-transcript/index.html
2 “Tickborne Diseases of the United States” https://www.cdc.gov/ticks/diseases/index.html
3 “Mother who lost toddler from tick borne illness spreads awareness of dangers as weather gets warmer” https://www.wthr.com/article/mother-who-lost-toddler-from-tick-borne-illness-spreads-awareness-of-dangers-as-weather-gets
4 “Fatal Cases of Rocky Mountain Spotted Fever in Family Clusters ..” https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5319a1.htm
5 “The relationship between red meat allergy and sensitization to gelatin and galactose-alpha-1,3-galactose” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3340561/
6 “Anaphylaxis to succinylated gelatin in a patient with a meat allergy: galactose-α(1, 3)-galactose (α-gal) as antigenic determinant.” https://www.ncbi.nlm.nih.gov/pubmed/25439422
7 “Flu Vaccine Allergy May Be Attributed to Gelatin, Not Egg” https://www.medscape.com/viewarticle/814826
8 “AAAAI - Gelatin Allergy” http://www.aaaai.org/ask-the-expert/gelatin-allergy
9 “Anaphylaxis after zoster vaccine: Implicating alpha-gal allergy as a possible mechanism” https://www.jacionline.org/article/S0091-6749(16)31455-5/fulltext
10 “Shingles And MMR Vaccines May Trigger Anaphylaxis In Meat-Allergic People, Researchers Call For Awareness” https://www.inquisitr.com/4308409/shingles-and-mmr-vaccines-may-trigger-anaphylaxis-in-meat-allergic-people-researchers-call-for-awareness/
11 “Alpha-Gal (Mammalian Meat) Allergy: Implications for Pharmacists” http://www.pharmacytimes.com/publications/issue/2015/may2015/alpha-gal-mammalian-meat-allergy-implications-for-pharmacists
12 “Ticking Meatmares - Lone Star ticks hunt in packs and spread an allergy to beef and pork.” https://grist.org/article/lone-star-ticks-are-a-carnivores-nightmare-and-theyre-just-waking-up/
13 Video - Lone Star Tick swarm taken/posted on 5/11/18 on a bicycle path in Rogers, AR at 11:58am https://www.facebook.com/891434447665440/videos/1148184098657139/
14 2018/04/27 KUAF / NPR podcast announcing the Alpha Gal Encouragers Community Awareness Event http://kuaf.com/post/event-raises-awareness-tick-borne-illness#stream/0
15 2018/05/01 KFSM Channel 5 News http://5newsonline.com/2018/05/01/rogers-woman-shares-experience-after-tick-bite-causes-meat-allergy/
16 2018/05/03 FOX News.com http://www.foxnews.com/health/2018/05/03/arkansas-woman-develops-deadly-meat-allergy-after-tick-bite.html
17 2018/05/07 Fox 24, NWA Homepage http://www.nwahomepage.com/news/fox-24/rogers-woman-bit-by-tick-causes-mammal-meat-allergy/1163361133
Jennifer Burton
Founder and Outreach Coordinator, Alpha Gal Encouragers-NW Arkansas
Marty and Theresa Denham
Dear Fed TBDWG committees and subcommittees,
I live in Oregon and 17 years ago my daughter was given less than a year to live - She had arthritis, renal issues, connective tissue disorders and was in congestive heart failure, had serious seizure disorders, had two TIA strokes, and became the earliest case of early onset Alzheimer’s at age 11. She was unable to function.
Backtrack to 7 years earlier, my daughter had been but by a tick, presented with classical rash at her hairline and then developed fevers, arthritis and other things. To each physician I asked if this could be Lyme Disease, I was told no and finally was accused of munchausen by proxy from her pulmonologist after she was released from the hospital for a cardiac insufficiency requiring procedures ,
An out if state friend suggested she may have Lyme disease - I was afraid to ask again in fear of more CPS investigations. I was tired, distraught and fearful my daughter would die. At 11 she was having heart attacking symptoms - we told the ER doctor if they refused to run the lyme test we would take her back east and if she had it we would take legal action. They tested, she was CDC positive on Elisa and western blots.
We took her to the east coast - where her pediatric lyme specialist began treatment. His first words as we walked in the door were “ I was worried she would die before I saw her.” Incidentally he saw her on a Sunday morning-he sent us directly to the New Haven hospital where he began treating our daughter.
Upon arriving home, to Oregon, we were told her tests were false positive by Infectious Disease doctors at OHSU.
Insurance refused more treatment based on Oregon’s Policy and the CDC standards.- despite serious continued symptoms and post treatment positive tissue and blood PCR’s after six weeks of treatment from 3 laboratories .
We chose to continue out of pocket ILADS long term antibiotic therapy for our daughter with out of state doctors since none would work with our pediatrician specialist, and after 6 months of oral and 18 months of IV therapy, our daughter recovered and is no longer on cardiac or seizure medications.
Today 17 years after her diagnosis, and 25 years after her tick bite our daughter has healthy children and a quality of life we could never imagine.
I was robbed the joys of motherhood, my career and my friendships, she was robbed a normal childhood, education and the right to live without pain. (her seizures created persistent nerve pain due to CNS damage)
But worse than any of those- Mother’s today still face the pain of watching their kids suffer ( and some die) , family degradation due to the stress and financial impact due to lack of testing, understanding and insurance and medical interferences with treatment based on IDSA standards which many states stick to despite current science showing other guideline options .
Over 3 years of heavy antibiotics not only saved my daughter, but allowed her to have a better immune system , stop the progressive and severe damage from the disease, and allowed her to have a healthy beautiful family... she would have died according to OHSU specialists who gave her less than a year, but were unwilling to accept and treat an affirmative diagnosis of tick borne infections.
This lack of access to care needs to change - the tools are there, the attitude is not.
Kindly,
Marty and Theresa Denham
Enid Haller
My name is Dr. Enid Haller. I hold a Masters Degree in Social Work and a PhD in clinical psychology. I am on the board of the Dean Center for Tick-Borne Illness in Boston and I am a previous member of the Tick-Borne Disease Working Group subcommittee on Access to Care Services and Support to Patients. I have been a patient-advocate ever since my daughter, my husband and I were all diagnosed with Chronic Lyme and co-infections 11 years ago.
Nine years ago I founded the Lyme Support Group of Marthas Vineyard and 7 years ago the Lyme Center of Marthas Vineyard. For all these years, I have been trying to educate anyone who will listen that we have a Lyme epidemic on our hands. Some would listen, but as I have watched the number of Lyme patients grow over the years, I am astonished to witness no change in how our government agencies have responded.
Why is it that our government is ignoring this vast and growing patient population? I have been trying to figure this out for 11 years and now ... because I was able to experience things first-hand from the inside ... I might just have some insight. I fear that money, greed, power, prestige, ego and careerism play a part in how we have made no progress with Lyme disease in over 35 years. I think that the individuals in power at these agencies in Washington have conflicts of interest and invisible, ulterior motives.
Twenty-five years ago in Dearborn Michigan an illicit pact was forged. In 1993, the CDC panicked. In recognizing that Lyme disease was a very serious problem, their Plan-A was to establish a pathway toward a commercial Lyme vaccine. There was no Plan-B. So ... at the Second National Conference on Serologic Diagnosis of Lyme Disease on October 27-29, 1994, in Dearborn, Michigan … they activated Plan-A which had two important parts. First, was to establish a phony, overly narrow disease case definition (the rash-only), so limited that the FDA could easily measure the efficacy of a future vaccine in a population. And, second, was to implement a generally ineffective diagnostic testing system (a Western Blot with the most important protein bands removed) that would side-step the anticipated problem of throwing many false-positives in a future population that will have widely taken the vaccine.
This is horrendously bad medicine that fails common sense. The problems they created in doing this are significant and have for decades distracted honest medical research from addressing Borrelia and the co-infections head-on. This is bad, but the IDSA has made matters worse by miseducating doctors and patients about the signs and symptoms of Lyme and all the co-infections. Nobody can tell if they have Lyme or not; or what a co-infection feels like. When these go undiagnosed for a year or more, they go chronic and that's when any hope of a normal life ends.
Having a bad testing system that was designed and compromised for a future vaccine that does not exist is ironic enough; but having a toxic OspA vaccine given to millions of people with a likely high rate of latent, unrecognized Lyme co-infections will destroy millions of families' lives. They could not have made it worse if they tried. AND THE DISINFORMATION IS STILL CIRCULATING and keeping people from recognizing the danger! "Dearborn" is a name in the Lyme World that lives in infamy.
I believe the Dearborn meeting is the source of the long disinformation campaign about Lyme. It's the point when they established the inadequate testing design; it's the point when they rolled out confused diagnostic criteria, the bogus disease definition and the phony diagnostic codes; and it's the point when the IDSA established its threatening treatment guidelines that, to this day, prevent doctors from treating and health insurance companies from paying claims.
They made sure that disinformation about Lyme was included in the educational facilities all over the US and this was taught to all of our healthcare professionals. The CDC and the IDSA are responsible for the Lyme fiasco. And the lack of transparency in their funding and deliberation keeps the situation from getting better.
This is why I understood the horrible feeling that Karen Vanderhoof-Forschner had in her stomach when she joined the Working Group and co-chaired the patient support subcommittees. I had never met Karen before but I knew of her reputation. Because she had given Lyme to her son Jamie in utero 40 years ago and he died from Lyme disease when he was 5 years old, she was motivated to establish the very first Lyme Support Group, the Lyme Disease Foundation.
If it had not been for Karen's ground-breaking work, we would not be here today. It was an honor to serve under her on the subcommittee, and her agenda for our paper was correct. But I witnessed Karen being destroyed before my eyes. From the first day, Karen was pushing for transparency in the Working Group and subcommittee work. She first asked that the public be informed of everything the Working Group was doing; she asked that the agenda and minutes of each meeting be posted on the website; she asked that all the public comments and emails and phone calls be made public; she pushed for a thorough literature review of any previous information on Lyme to be shared with all subcommittees; and she insisted that all conflicts of interests be openly reported. Sadly, none of this happened.
Karen felt that the Working Group was in violation of the Sunshine Act and violating the rules of the Federal Advisory Committee Act (“FACA”) This did not go over very well with the Working Group. Then Karen was over-powered and pushed out by two of our subcommittee members, but I believe that the order to get rid of her came from someone senior in the Working Group leadership. Once Karen was forced to resign, then everything turned away from transparency. I was the only member who spoke up week after week that the public has a right to know what is going on here. The same two members of my subcommittee always shot this concept down. Then, since we were given free reign to write about what we chose, I chose the subject of Transparency and the History of Lyme – two topics they didn't want to know about.
In the last week of group meetings, when I had to announce what I had been working on for the last 3 months, I was removed from the Working Group. But before I was removed, I was gaslighted, bribed, and finally discredited and fired. I ask you ... is this how our government works? I still have my Transparency and History of Lyme paper and I want it to be added to the public recorded like it would have been on the May 1st Working Group deadline. I ask to be reinstated on the Working Group, and I am seeking Karens' empty voting chair on the Working Group so I can oversee the transparency of proceedings.
We need a watch-dog in close proximity to make sure our interests are being protected. I want to be that watch dog.
I have seen corruption for the last 11 years, first on Martha's Vineyard and now in Washington and I'm tired of being silent. It is time to reveal the ugly truth. I ask, for once, can we do this the right way? For the sake of all the people who are already sick and about to get sick … I ask ... PLEASE let us not have a Dearborn 2. It is time to demand transparency so we know who is conflicted in their work behind this disease, and to make sure that the system can no longer be rigged against the patients. It was an honor and a privilege to serve all of you, and I never would have let the Working Group on my own accord.
Enid Haller LCSW, PhD
Lyme Center of Marthas Vineyard
Stephen and Mary Jane Heppe
To Whom it May Concern,
Our son, Vaughan Heppe, died last October as a result of Lyme-induced encephalopathy. He was diagnosed in 2005, and we couldn’t get any MD’s in Oregon to treat him. In fact, they were antagonistic toward his treatment protocol outlined in ILADS protocols. My husband and I have been preparing for our son’s Celebration of Life ceremony, which is this Saturday, May 19. Vaughan was 25 years old, and he had a very bright future. This disease and lack of access to care took everything away. Because of his brain inflammation, mental illness set in, and Vaughan lost hope. He committed suicide last October 2, 2017.
Very sincerely,
Mary Jane Heppe
Dr. Stephen Heppe
Lorraine Johnson
My name is Lorraine Johnson, JD, MBA. I am the Chief Executive Officer of LymeDisease.org. I am an attorney advocate on issues related to the medico-legal and ethical aspects of Lyme disease and have published over 40 peer-reviewed articles on this topic. I have also served as a patient representative on the Pathogenesis, Transmission, and Treatment subcommittee of the Tick-Borne Disease Working Group.
Overall, I was pleased with the May 10, 2018, meeting. However, I have serious concerns regarding the presentation of the Vaccine and Therapeutics subcommittee.
- The subcommittee was heavily weighted with like-minded, pro-vaccine scientists, with only one patient representative.
- The Lyme community has many questions about the safety and efficacy of an OspA vaccine. It does not appear that such questions were thoughtfully considered by this subcommittee. Had patient advocacy organizations been represented on this subcommittee, there would surely have been a minority report.
- The verbal presentation did not address the documented injuries and other reasons LYMErix was withdrawn from the market, which I will lay out below.
People in the Lyme disease community know the history of the LYMErix vaccine, including the many injuries that occurred, resulting in a class action law suit. Failure to address these safety issues in the Vaccine and Therapeutics subcommittee report will lead to distrust and dissension regarding future Lyme vaccines.
Dr. Raphael Stricker and I published a letter to the editor on Lyme vaccines in Lancet in 2014. The letter responded to an article by employees of Baxter, which has a vaccine in development. The following is a copy of that letter:
Lyme disease vaccination: safety first
In the Article by Nina Wressnigg and colleagues1 and the related Comment by Paul Lantos2 describing a novel Lyme vaccine, the authors attempt to avoid discussion of the side-effects of the previous Lyme vaccine, LYMErix (SmithKline Beecham, Pittsburgh, USA). This approach to safety issues bodes ill for the new Lyme vaccine candidate.
LYMErix was put on the market in 1998 and withdrawn by the manufacturer in 2002, ostensibly because of poor sales. However, the so-called poor sales were related to safety concerns raised in a class-action lawsuit by more than 400 patients who claimed that they developed Lyme-like symptoms after vaccination with LYMErix.3,4 Subsequent studies showed that outer surface protein A (OspA), the antigenic component of Borrelia burgdorferi used to create both LYMErix and the new candidate vaccine, induced joint-reactive and nerve-reactive antibodies in animals and human beings vaccinated with the protein antigen.3–6 Even more disturbing, other studies indicated that LYMErix induced reactivity against multiple target antigens that were never characterised, and these studies called into question the OspA specificity of the vaccine.7,8 By withdrawing LYMErix when it did, the manufacturer avoided releasing phase 4 post-marketing data that probably would have shown increased side-effects related to the vaccine.9 The data have never been disclosed, and this lack of disclosure has fostered persistent patient mistrust of Lyme vaccine manufacturers.
Wressnigg and colleagues provide minimum safety data about the new OspA-based Lyme vaccine, whereas Lantos glosses over the “largely unsubstantiated safety concerns” about LYMErix. Adoption of this view by Lyme vaccine manufacturers, regulators, and promoters has shaken patient confidence in Lyme vaccines despite the fact that this patient population is generally pro-vaccination.10 Any new Lyme vaccine will need extensive safety testing, more transparency about side-effects, and improved patient communication on the part of the vaccine manufacturer to allay valid patient concerns about safety.4,10 Let’s hope that history does not repeat itself because Lyme vaccine manufacturers, regulators, and promoters once again underestimate or ignore justified patient concerns about Lyme vaccination risks.
References
- Wressnigg N, Pöllabauer E-M, Aichinger G, et al. Safety and immunogenicity of a novel multivalent OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomised, dose-escalation phase 1/2 trial. Lancet Infect Dis 2013; 13: 680–89.
- Lantos PM. Lyme disease vaccination: are we ready to try again? Lancet Infect Dis 2013; 13: 643–44.
- Stricker RB. Lymerix risks revisited. Microbe 2008; 3: 1–2.
- Smith P, Gaito A, Marks DH. Transcript of FDA Lymerix meeting, Bethesda, MD, January 22, 2002. http: //www.lymediseaseassociation.org/ index.php?option=com_content&view =article&id=532: lymerix-meeting&catid=129: hhsfood-a-drug-administration-fda&I temid=531 (accessed Nov 29, 2013).
- Souayah N, Ajroud-Driss S, Sander HW, Brannagan TH, Hays AP, Chin RL. Small fiber neuropathy following vaccination for rabies, varicella or Lyme disease. Vaccine 2009; 27: 7322–25.
- Marks DH. Neurological complications of vaccination with outer surface protein A (OspA). Int J Risk Saf Med 2011; 23: 89–96.
- Molloy PJ, Berardi VP, Persing DH, Sigal LH. Detection of multiple reactive protein species by immunoblotting after recombinant outer surface protein A Lyme disease vaccination. Clin Infect Dis 2000; 31: 42–47.
- Fawcett PT, Rose CD, Budd SM, Gibney KM. Effect of immunization with recombinant OspA on serologic tests for Lyme borreliosis. Clin Diagn Lab Immunol 2001; 8: 79–84.
- Nardelli DT, Munson EL, Callister SM, Schell RF. Human Lyme disease vaccines: past and future concerns. Future Microbiol 2009; 4: 457–69.
- Smith P. Remarks to Vaccines and Related Biological Products Advisory Committee, Bethesda, MD, January 31, 2001. http://www. lymediseaseassociation.org/index. php?option=com_content&view=article &id=262: vaccine-remarks&catid=80: controversy&Itemid=76
Sincerely,
Lorraine Johnson, JD, MBA
CEO LymeDisease.org
Dorothy Leland
My name is Dorothy Leland. I am the mother of a daughter who was severely disabled by Lyme disease as a teenager. With treatment from an ILADS-affiliated MD, using a variety of modalities, her health has significantly improved over what it once was.
I’m the co-author of the book “When Your Child Has Lyme Disease: A Parent’s Survival Guide”; I write a blog called “Touched by Lyme”; and I am Vice-President and Director of Communications for LymeDisease.org.
I have followed the proceedings of the Tick-Borne Diseases Working Group closely. Overall, I was quite heartened by the May 10, 2018, online meeting. It seemed to embody what the Working Group was supposed to be—stakeholders with a variety of viewpoints examining all relevant information on different subject areas.
My assessment of it changed drastically with the presentation of the Vaccine subcommittee. It appeared that no attention had been given to the Lyme community’s valid concerns about safety problems with the LYMErix vaccine. When the presenter was questioned about this by Working Group member Pat Smith, he was very dismissive. He said something along the lines of “there’s no reason to rehash the past. Let’s just move forward with the vaccine.”
Don’t let this inappropriate situation torpedo the mission of the Working Group. Stick with the plan: the diverse views of a range of stakeholders should be appropriately considered—not blatantly ignored by people who appear to have closed minds on the subject.
Dorothy Kupcha Leland
Lonnie Marcum
My name is Lonnie Marcum, I am a licensed Physical Therapist. I became active in the Lyme community after my daughter was diagnosed with tick-borne diseases in 2013—this after going nearly a year with an undiagnosed infection.
I have been an enthusiastic witness to the entire process of the Tick-Borne Disease Working Group (TBDWG) and am incredibly impressed with the volume, depth and breadth of information that was provided by the subcommittees on May 10, 2018.
In light of the new CDC report [1] stating the explosion of tick-borne disease over the past decade and the history of the IDSA/CDC fast tracking the previous Lyme vaccine, I can’t help but suspect this is leading to a new Lyme vaccine being fast tracked to the public.
I do have several concerns about omissions during the presentation that was given by the Vaccine and Therapeutics subcommittee which include:
- The lack of balanced patient membership on the subcommittee.
- The Anti-tick vaccine is presented in the written report but was not presented during the public meeting.[2] The ANTIdotE vaccine has far greater potential than a vaccine for a single strain of Borrelia and should be given further consideration. [3]
- The veterinary approach to Lyme vaccine which takes into consideration previous (latent) infection and genetic differences between animals. [4]
- LYMErix vaccine injury and the ensuing class action law suit (see first item below)[5,6]
- The lack of a minority report.
I would like to call attention to two bodies of work that warrant review by the TBDWG prior to voting on the recommendations of the Vaccine and Therapeutics subcommittee.
The first are special reports written by Pat Smith, the president of Lyme Disease Association following a private meeting with the FDA on the LYMErix vaccine. In these reports Pat addresses several questions for the FDA as well as testimony to the many patient reports of injury:
“Most patients with adverse events are not reported to VAERS by physicians. I attend many events all over the Northeast, and the vaccine and associated problems are always brought up to me, unsolicited on my part. “
The second is a published letter to the editor of the Lancet, written by Lorraine Johnson, JD, MBA and Dr. Raphael Stricker on the LYMErix vaccine. [7] In this fully referenced letter, the authors note:
“by withdrawing LYMErix when it did, the manufacturer avoided releasing phase 4 post-marketing data that probably would have shown increased side-effects related to the vaccine. The data have never been disclosed.”
As the current subcommittee for the Vaccine and Therapeutics did not address these public concerns I would like to suggest the TBDWG allow other members of other subcommittees to provide a written minority report.
Sincerely,
Lonnie Marcum, PT
References:
- Rosenberg R, Lindsey NP, Fischer M, et al. Vital Signs: Trends in Reported Vectorborne Disease Cases — United States and Territories, 2004–2016. MMWR Morb Mortal Wkly Rep 2018;67:496–501. DOI: http://dx.doi.org/10.15585/mmwr.mm6717e1.Vaccine
- Vaccines and Therapeutics. Subcommittee’s Report to the Tick-Borne Disease Working, May 10, 2018. https://www.hhs.gov/ash/advisory-committees/tickbornedisease/reports/vaccines-and-therapeutics-2018-5-9/index.html
- Sprong H, Seemann I, et al. Parasites and Vectors. (2014) ANTIDotE: anti-tick vaccines to prevent tick-borne diseases in Europe https://doi.org/10.1186/1756-3305-7-77
- Littman M, Goldstein R. Today’s Veterinary Practices (Jan/Feb 2014) Vaccinating Dogs Against Lyme Disease: Two Points of View. http://todaysveterinarypractice.navc.com/perspectives-vaccinating-dogs-against-lyme-disease-two-points-of-view/
- GroupSmith, P, Gaito, A, and Marks, DH. Transcript of FDA Lymerix meeting, Bethesda, MD. ((accessed May 13, 2018).) http://www.lymediseaseassociation.org/index.php?option=com_content&view=article&id=532: lymerix-meeting&catid=129: hhsfood-a-drug-administration-fda&Itemid=531
- Smith, P. Remarks to Vaccines and Related Biological Products Advisory Committee, Bethesda, MD. ((accessed May 13, 2018).) http://www.lymediseaseassociation.org/index.php?option=com_content&view=article&id=262: vaccine-remarks&catid=80: controversy&Itemid=76
- Stricker, R, Johnson, L. Letter to the Editor, The Lancet (Jan. 2014). Lyme disease vaccination: safety first. DOI: https://doi.org/10.1016/S1473-3099(13)70319-0
Kristine Mason
In 2005, I had a standardized Lyme test. While I did show evidence of Lyme Disease, the lab did not meet CDC criteria (Western Blot, I believe). I grew sicker and sicker. I went from being a primary caregiver for my mother and 2 jobs to barely being able to manage a part-time job and keep my home I worked so hard to own.
I did not get treatment during the crucial period upon falling ill. There was no treatment BECAUSE of CDC criteria for positive Lyme. Eight or more years later, I was diagnosed with Lyme, Babesia, and Bartonella (mycoplasma too) by other more sensitive tests paid for out-of-pocket. Several years later, I have almost spent my retirement savings and every dime I make... II trying to get well!!! I am still quite debilitated and frustrated by lack of acknowledgement by AMA, IDSA.
My brother-in-law of whom is a biostatitician, wondered why there IS such minimal research in this area. How do you explain this?
Please know we are not "whiners". We are asking for what anyone with a chronic illness, an INFECTION...that is slowly killing them would ask. We hope for acknowledgement, true testing/ research and RESPECT of which we have unfairly been so unfairly excluded.
That said, your working group brings hope and signs for movement. Improved understanding will only help public health. Thank you.
Kristine Mason
Littleton CO
Timothy M. Opiela
Dear Tick Borne Disease Working Committee:
Although my nine years research has been focused on Alpha gal Allergy, I wanted to share with you a key over looked gap in the transmission of Tick borne diseases.
After completing three separate sample studies of people (sample size 350) with confirmed cases Alpha gal Allergy, just over 90% of them were pet owners, extremely high given the pet general population pet ownership in the US.
I did conduct a sample similar study with a Lyme group and found similar high numbers of pet ownership.
This lead me to review Pet Tick prevention products. Taking time to carefully review the carefully crafted inserts within the packages, the majority of these products, do what they are designed to do protect the pet by first repelling the tick. The repelled tick has found it's way into the home.
Furthermore reading the inserts revealed a key gap of opportunity.
There is a time lag /gap of potentially several hours for the product to actually killing the tick.
The majority of the pet ownership public is unaware of these protection gaps. Thus putting themselves and families at greater risk for tick bites and tick borne disease transmission.
Given these two gaps, there is a real potential for the ticks to fall off or be rubbed off with a hug or petting within the home during this period of time.
Thus putting pet owners and their families are greater risk of being bitten by a tick. Still further, this permits the opportunity for a tick to feed and lay eggs within a home such as on bedding, couches, carpeted floors.
Reflect for a few seconds, if you are a pet owner where your dog or cat goes in your home, lays down, sits within a two hour period of time after coming in from being outside. Note this time gap is from one of the better products on the market, most tick prevention products have time frames gaps are much larger and opportunity greater a bite and transmission.
Under informed pet owners should be supplied with Bold Warning Labels and Education on these pet protection products about this key gap that puts themselves and their family at risk for contacting a tick borne disease.
Is pet ownership a big risk factor for transmission of Tick borne disease? I suggest it is within the top two.
Ticks, specifically Lone Star Ticks, have evolved as their population numbers have grown since the 1700's hunting for a host from livestock grazing fields where they were first discovered here in America to backyards of pet owners.
The key mutual linking component being the two is solid bio-waste contains grain which attracts forest fragmented mammals the carry ticks with a high percentage of Tick borne pathogens.
An effective general public awareness educational campaign on this key gap in Tick prevention awareness will greatly reduce the number of transmitted Tick borne diseases especially to children living within a home with a pet.
I would be happy to discuss in detail front of the committee in person, if invited.
Sincerely,
Timothy M. Opiela
Patricia Parker
To Whom It May Concern:
I have a 28 year old son who contracted Lyme from a tick bite almost 4 years ago. My son being highly intelligent, well educated, kind, attractive and with basic common sense was on a journey to a successful life. After contracting Lyme his life has been demolished. He told me recently that he is “just a shell” and that he has “nothing to look forward to or be excited about in life.” He battles fatigue, muscle pain, depression, brain fog and inability to concentrate, insomnia and many other symptoms. He has lost his job, all social contact and any hope of a successful career or relationships. Lyme Disease and the co-infections Bartonella, Babesia, and Mycoplasia have completely ruined any hope for the life that he dreamed of. I fear if help and healing are not obtained that he could take his own life.
My question is why would the CDC, Infectious Disease Doctors, and the World Health Organization and other organizations let this happen to many thousands of people in America and other countries? Why would those who have the ability to impact this disease with research and treatment protocols not only deny the chronic form of this disease but actually punish the few doctors willing to help this population of people? Why would the Infectious Disease Association and the CDC continue to deny that the Chronic form of this disease exists even in the face of research that proves that it does? Have our organizations in America become so corrupt that the very people that they are tasked to watch over help, and heal our people are choosing money, power and greed?
This is travesty and I beg you to move forward in a meaningful way to get help for those who have Lyme and Co-Infections and those who will soon have this array of Diseases. Do not turn your backs, stand up and represent all of those who need help and healing. Take action and fight! Do the right thing!!!
Patti Parker, RN, CCM
Lori Lynn Sikes
To Whom It May Concern:
I am requesting an investigation into the Arkansas Department of Health's reporting practices of Lyme Disease in Arkansas.
In recent history, representatives of the Governor's office and the media have all asked the same questions. Repeatedly, the same answers have been returned.
THERE IS NO LYME DISEASE IN ARKANSAS.
Why am I concerned with this issue?
Because I have Lyme Disease. I know of 8 different people in my immediate community that have positive blood tests for Lyme Disease and a Doctor's diagnosis. I have personally spoken with hundreds of citizens in the state of Arkansas who have also tested positive for Lyme Disease.
Most have gone undiagnosed for years, resulting in debilitating illness.
The Arkansas Department of Health discourages Doctors from testing or even considering a diagnosis.
There is not appropriate or accurate education for Doctors.
Doctors do not report the disease correctly to the Arkansas Department of Health.
Infectious Disease Doctors in Whe Arkansas simply refuse to treat or even speak to someone with a positive blood test.
Other Doctors are hesitant now to even say the word "Lyme" in fear of scrutiny from their peers, and will not prescribe beyond the typical recommended dosage of antibiotics (despite continuing infection) in fear of their medical license being revoked.
Arkansas is among the highest in the nation for almost all other Tickborne Illness. The tick that is most widely known to spread Lyme Disease (Ixodes scapularis - Blacklegged ticks or Deer tick) is found across the state of Arkansas during all seasons. Ticks migrate on birds and all kinds of mammals across the nation.
The ADH claims that the Western Fence Lizard is a large factor in the alleged absence of Lyme Disease in our state.
The Western Fence Lizard is thought to harbor a protein that eradicates the bacteria that causes Lyme Disease in it's blood. http://www.anapsid.org/lyme/sceloporus.html
The problem is, we do not have the western fence lizard. We have a similar lizard - called the "Prairie Lizard" which although is similar in appearance, is genetically different from the Western Fence Lizard.
There have been NO studies on the lizard we have in Arkansas. In fact, I have spoken with every Herpetologist I can find within the state, and not one of them is familiar with the study - and there have been no studies on the population of the Prairie Lizard in Arkansas, or its relation to ticks.
When I asked the the ADH to provide any scientific studies backing their theory about these lizards in Arkansas, they admitted there were none.
According to the Idexx Laboratory canine tickborne disease prevelance map found here - http://www.dogsandticks.com/diseases_in_your_area.php , there have recently been 282 cases of Lyme Disease found in dogs in Arkansas. (Idexx is the most well known veterinary lab in the nation).
After my recently dog became ill with Lyme disease symptoms, I sent a small batch of ticks from our land into the Nate Neito Lab in Arizona to be tested. I received a report that one of them tested positive for Borrelia Burgdorferi (Lyme Disease).
Between 2015 - part of 2016, As required by law; a total of 911 Doctors and laboratories sent positive test results from Arkansas patients with Lyme Disease to the Arkansas Department of Health....After allegedly sorting through "duplicates", the stack was narrowed down to only 582 total.
Keep in mind, a doctor or lab would not send in a lab result to the ADH unless it met the CDC requirements as a positive test and said POSITIVE in the results
The ADH determined that of those 582 positive lab reports....287 didn't have enough clinical information to absolutely determine a positive confirmationin their opinion; 282 were false positive. "Not cases in their opinion"; 11 were considered "probable cases"; and 2 were confirmed, but yet they still only consider those probable cases. You can see these statements made by the ADH in the video at about the 30 minute mark. https://vimeopro.com/healthyarkansas/20170525.
* Towards the end of the video, you will hear the state veteranarian (who hasn't even practiced medicine in decades) say that people in Arkansas who "feel" they have Lyme disease actually just have something else.
In addition, the CDC recently release a statement that states that it may be necessary to get several Western Blot tests in order to show positive antibodies for Lyme Disease. http://abcnews.go.com/GMA/video/cdc-advises-multiple-lyme-disease-tests-tick-bite-48364357
Many people get a "bullseye rash" and immediately go to their Doctor for testing. What most Doctors are no of, is that it takes at least 3-4 weeks typically for a person to create the antibodies that are specific to Lyme Disease on a test. There is one other test available- a PCR test that has already been approved for use in early detection of west nile virus and other infectious diseases - that can more accurately detect Lyme Disease antibodies in the blood stream when it is within a month of original infection - but the Arkansas Department of Health recently release a statement how they do not support PCR testing for early Lyme disease testing at all.
Dr. Richard Horowitz, a leading expert in treating tick-borne diseases, makes a brief statement regarding a recent article reported in the Democrat-Gazette: https://www.lymedisease.org/response-fake-news-article-lyme-co-infections/
Almost all Arkansas who are diagnosed with Lyme Disease must travel out of state for treatment. Most specialist are not covered by insurance. Most patients are too ill to travel out of state anyway.
I would expect a state with some of the most cases of Tickborne Illnesses in the entire nation would have a Tickborne Disease Specialist, but we have no one.
Infectious Disease Doctors are either unwilling to treat - or are practicing medicine based on 25 year old science - just like the Arkansas Department of Health. In many cases, a month of Doxycycline WILL knock out a newly acquired case of Borrelia Burgdorferi - but after the spirochetes bore into every area of the human body and begin doing damage - a simple dose of antibiotics is not enough.
I could go on and on for hours about the atrocities I have heard first hand - Arkansans dying because of Lyme Disease. Losing their careers. Families. Becoming homeless.
I receive messages weekly - sometimes daily - from Arkansans with newly developed "bullseye" rashes - Not knowing where to go or what to do when they have no Doctor who will treat them, and they cannot afford to travel out of state. I hear stories daily of Doctors treating patients like they are mentally ill. Denying treatment. Saying their CDC positive Western Blot tests are actually "false positive".
The ADH used to regularly report Lyme Disease in Arkansas prior to 2005. What happened? The cases across the nation has grown from an estimated 30,000 per year to at least 300,000.
WHY HAS ARKANSAS REMAINED AT ZERO?
The more logical question is - "Why isn't the Arkansas Department of Health reporting positive cases, and continually denying the existence of the disease spreading into Arkansas?".
In the past, everyone involved seems to just take this information - ask the ADH what their response is to it- and that's the end of the story. No investigation. No questions asked. Nothing has changed.
IT IS TIME FOR CHANGE AND ACCOUNTABILITY.
Thank you for your time, and I look forward to your response.
Sincerely,
Lori Lynn Sikes
Sheila Statlender
I was alarmed by the lack of balance on the Vaccine sub-committee, including the omission of significant and pertinent articles (eg, Latov et al), documenting the adverse neurological effects of Lymerix and related concerns. The selection of the vaccine sub-committee co-chairs did not reflect balanced perspectives, nor did they select experts and advocates capable of representing the many valid concerns surrounding this issue. I urge you to correct this imbalance in subsequent iterations of the vaccine sub-Committee and related TBDWG endeavors. If it is not corrected, the credibility of this entire enterprise will be jeopardized, playing into the fears of many in the Lyme community that the TBDWG is merely a vehicle to promote a Lyme vaccine already in the pipeline. Lyme patients are not anti-vaccine and should not be dismissed as such: they want safe and effective vaccines, with honest accountability.
Sheila M. Statlender, Ph.D.
Newton Centre, MA
Raphael Stricker
The TBDWG Vaccine and Therapeutics Subcommittee report presents an unsatisfactory analysis of the LYMErix vaccine debacle. The spin in the report is a classic example of blaming the victims for their misfortune while ignoring the problems leading to that misfortune.
The report echoes previous publications implying that the science underlying the LYMErix vaccine was sound and beyond question, that the vaccine was proven to be safe beyond a shadow of a doubt, and that the antiscience lobbying of misguided Lyme activists brought down the vaccine. Considering that the LYMErix vaccine was the object of a class-action lawsuit brought by patients who claimed to have been harmed by the vaccine (1), and in view of the safety concerns described below, the spin in the report is impossible to defend.
The report asserts that the LYMErix vaccine was proven to be safe.
This assertion ignores substantial evidence of LYMErix-induced patient harm in the peer-reviewed medical literature (2-6), and studies using animal models and in vitro systems support these safety concerns (7,8). The vaccine-induced rheumatological and neurological complications are what alarmed the Lyme community and ultimately led to rejection of the vaccine as unsafe. An intriguing and disturbing scientific aspect of the LYMErix vaccine is that, although it was made from a subunit protein, the vaccine elicited all manner of immune responses in vaccinees, and these remain unexplained (9,10).
Thus there was significant clinical and laboratory evidence underlying doubts about the safety of this ill-fated vaccine.
Previous publications have blamed Lyme activists for spreading fear about LYMErix that ultimately diminished its use and prevented an adequate assessment of its clinical value. In reality, the vaccine was pulled off the market to avoid disclosure of Phase IV data that probably would have shown limited efficacy and significant safety concerns related to LYMErix (11-13). That data has never been publicly released.
A previous report on LYMErix divided the Lyme universe into "orthodox" and "heterodox" camps. The "orthodox" camp defines Lyme disease in a narrow fashion that excludes various clinical manifestations and chronic forms of the disease despite growing evidence to the contrary (14,15). Thus a patient who develops fibromyalgia or fatigue symptoms after receiving the Lyme vaccine would not have complications related to the vaccine because fibromyalgia and fatigue are separate entities unrelated to Lyme disease. This narrow definition serves to enhance the benefit of the vaccine (ie, no Lyme symptoms) while dismissing potential complications of the vaccine (ie, fibromyalgia and fatigue are separate and unrelated problems). It is easy to see why the Lyme community would be reluctant to go along with this selective view of the vaccine.
In contrast, patients in the "heterodox" camp allegedly embrace a broad view of Lyme disease that requires prolonged treatment with antibiotics and supplements rather than any attempt to prevent the disease. The implication that this patient group is opposed to a Lyme vaccine because its members are invested in being chronically ill and taking prolonged courses of medication strains credibility. The recognition that numerous patients fail the "orthodox" approach to Lyme disease and remain chronically ill is what drives these patients to seek better treatment, and certainly a vaccine that is safe and effective in avoiding a poor clinical outcome would be welcome (16).
Unfortunately as outlined above, LYMErix was not it.
In summary, the LYMErix vaccine failed in large part because valid safety concerns were ignored, and future variations of LYMErix that whitewash these concerns risk the same negative outcome.
References
- LDA website: Vaccine lawsuit. Available at: https://www.lymediseaseassociation.org/about-lyme/controversy/vaccine/1157-vaccine-suit-lda-ltr-a-judgement. Accessed May 12, 2018.
- Rose et al, J Rheumatol. 2001;28:2555-7.
- Latov et al, Periph Nerv Syst. 2004;9:165-7.
- Souayah et al, Vaccine 2009;27:7322-5.
- Nardelli et al, Future Microbiol. 2009;4:457-69.
- Marks DH, Int J Risk Saf Med. 2011;23:89-96.
- Croke et al, Infect Immun. 2000;68:658-63.
- Alaedini & Latov, J Neuroimmunol. 2005;159:192-5.
- Molloy et al, Clin Infect Dis. 2000;31:42-7.
- Fawcett et al, Clin Diagn Lab Immunol. 2001;8:79-84.
- Hanson & Edelman, Expert Rev Vaccines 2003;2:683-703.
- Nigrovic & Thompson, Epidemiol Infect. 2007;135:1-8.
- LDA website: LYMERIX Meeting; LDA Meets with FDA. Available at https://www.lymediseaseassociation.org/about-lyme/controversy/vaccine/261-lymerix-meeting. Accessed May 12, 2018.
- Stricker & Johnson. Infect Drug Resist 2016:9:215-219.
- Middelveen et al. Healthcare (Basel) 2018;6:33.
- Stricker & Johnson. Lancet Infect Dis 2014;14:12.
Disclosure: RBS is a member of the International Lyme and Associated Diseases Society (ILADS) and a director of LymeDisease.org. He has no financial or other conflicts to declare.
Raphael B. Stricker, MD
David Thomas
To the TBDWG,
Please, I am listening to two sides of a very important issue. The issue is responsibilities of the TBDWG.
a. I am seeing many very intelligent proud individuals, concerned that some voices, that they feel may threaten there agenda or goals for the TBDWG.
b. The other a very knowledgeable adviser to the (I FEEL) very important FACA Law of 1992.
I have been approached by both sides. I am seeing a need to neutralize this argument or this may come to the end of this working group. There is some understanding that this project of TBDWG was not expecting to be as publicly active OR public actively interested in decision making as the committees would have liked. As perhaps going in and voting in certain practices that are working at this time or relieving certain obstacles that hinder the health of the community. This is a very complicated issue and both sides are getting frustrated. The working group side is working overtime and are getting very tired of there efforts and actually (I feel ) fumbling a bit over the rules of FACA to hurry to something that will stand the test of time. There is a person involved with Faca rule charged with this TBDWG to help with this guidance. Then there is the government expert that knows the road and is a Lyme disease survivor. I do not take sides on many things as I tend to wait and see what develops and perhaps there is a recovery back to the main agenda. I feel TBDWG needs to take a breath. The TOP seats TBDWG (I FEEL) need to take a class in FACA law. Or this working group will implode without it.
As for Public comments at the HHS page. This is totally blowing my mind. I am a publisher and in today's world. It is not that hard to get those comments read and published to the site. This is truly a fumble of any measure of responsibility. I do not understand why there is nothing but a couple of comments.
Transparency is what the community needs and wants. It is that simple, and they need it in time to make there grievances heard by their committee leaders. Not rewrites of someone that feels superior to their subordinates. Along with professionalism and responsibility. This has failed the Lyme community for 40+ years. TBDWG has a chance to turn this around.
PLEASE: Get it right. Thank you,
David R Thomas – Lyme Advocate
Pamela Weintraub
To the Working Group,
I am watching with cautious optimism - but also skepticism- as the various stakeholders gather in 2018 to attempt to understand and fix the colossal mess that Lyme and its coinfections have become in the landscape of medicine today.
Let me state directly: The best hope for patients was lost in 1994, the day that the disease definition was changed in Dearborne Michigan to accommodate production of a vaccine where the intent, according to the mainstream researchers I interviewed, was to keep the vaccinated seronegative. Instead of looking at an expanding, intensifying pattern of bands as before, physicians now would base diagnosis on a restrictive band pattern that was one of many —according to the manufacturer— that actually verified infection. Many of the sickest patients were left out in the cold.
At the same time, after its commercial release, the vaccine this artificial narrowing enabled -Lymerix- ended up generating reports of severe, very troubling side effects in a small but significant number of patients, according to 2002 testimony delivered to FDA by the lead researcher for the competing vaccine -which was pulled off the market for these reasons. A week after that disturbing, powerful closed-door meeting at FDA, Glaxo pulled Lymerix too, citing “poor sales.” If you believe this - I also have a bridge I can sell you. It defies belief.
I recommend that you go back to the drawing board on Lyme disease and it’s coinfections starting from scratch using the best biomedical technology available in 2018 - not throwbacks to old, crude technologies of the 1980s. I also recommend that you approach with requisite skepticism the party line that the OspA vaccine was flawless and re-examine the 2002 FDA testimony delineating all the possible deficits - not just the one epitope researchers now say they have adjusted to address possible autoimmune effects. If you allow these products and standards to stand without a fresh look using state of the art science and unbiased scientific eyes, the current chaos surrounding these burgeoning epidemics will only increase. On the other hand. the right resources in the right hands will take us to higher ground.
I am linking here to my chapter and reportage on the vaccine imbroglio of earlier days, covered in my book. CURE UNKNOWN, so that more nuances are clear. https://www.lymedisease.org/vaccine-chapter-of-cure-unknown/
Pamela Weintraub
Lyme disease survivor
Monica White
It has been a privilege to participate in this process. As a subcommittee member, I believe that overall the process worked well however, I am very concerned that the Vaccine and Therapeutics subcommittee report did not adequately represent patients’ interest nor present complete review of best available science. I was alarmed by the lack of balance on the Vaccine sub-committee, including the omission of significant and pertinent articles (e.g., Latov et al), documenting the adverse neurological effects of Lymerix and related concerns. The selection of the vaccine sub-committee co-chairs did not reflect balanced perspectives, nor did they select experts and advocates capable of representing the many valid concerns surrounding this issue. I urge you to correct this imbalance in subsequent iterations of the vaccine sub-Committee and related TBDWG endeavors. If it is not corrected, the credibility of this entire enterprise will be jeopardized, playing into the fears of many in the Lyme community that the TBDWG is merely a vehicle to promote a Lyme vaccine already in the pipeline. Lyme patients are not anti-vaccine and should not be dismissed It is critical that all sides are adequately represented and balanced to allow for a complete representation of the problems and the potential solutions/recommendations. as such: they want safe and effective vaccines, with honest accountability.
Respectfully,
Monica White
President/Co-founder
Colorado Tick-Borne Disease Awareness Association
www.coloradoticks.org
Anonymous Commenter
I object to the term "post treatment Lyme disease syndrome".
a) it is vague.
b) it implies there is only one treatment.
c) it implies there is only one infection, and it is linear.
d) it implies only symptomatic relief should be provided, by encouraging an algorithm of cure or syndrome
e) it contributes to discrimination to these patients of treatment options by medical providers and reimbursement by Medicare and insurance.
Members of a Subcommittee
To the TBDWG
We, the undersigned are members of a subcommittee. While we believe that overall the subcommittee reports process worked well, we are disturbed that the Vaccine and Therapeutics subcommittee report did not represent patients’ interest. It was led by two like minded people who, it appears, had their minds made up before they ever had any meetings. Furthermore, while they may have listened to other information, some of which is contained in the written report, such as the anti-tick vaccine which could block numerous common pathogens. Thus it is perhaps a better solution, was not even represented in their oral presentation.
The apparent bias of this subcommittee undermines the credibility of all of the good work done by the remaining subcommittees and could lead to the patient community not accepting anything you produce. We therefore, suggest the TBDWG look at the entirety of their report before making the final report for the secretary of HHS and congress. Furthermore, we suggest that the process used in the next round insures that all sides are adequately represented and balanced.
Respectfully,
Holly Ahern
Jill Auerbach
Paula Jackson Jones
Phyllis Mervine
David Roth
Monica White
