TBDWG February 12, 2018 - Verbal Comment Transcript
John Aucott: We’re making a transition now to the public comment that will be obviously a virtual comments and that will be handled by the group here. There will be eight people speaking. We want to remind people that we have to keep the time limit fairly strict to the 3 minutes per commenter. And let me go ahead and turn it over to the operator who is going to actually assist the individuals doing the comments.
Phone Operator: People may now provide public comment. The order in which they’ll be introduced is Julia Wagner, Beth Carrison-van der Heide, Jennifer Burton, Gary Sweeney, Timothy Opiela, Jennifer Platt, Jena Blair, and Kathy Nodolf. Each will have 3 minutes to speak, 15 seconds before the 3 minute time, you will hear an alarm. At three minutes, the phone will be muted, and I’ll proceed to the next speaker. The first speaker is Julia Wagner. Go ahead please.
Julia Wagner: Good afternoon. This is Julia Wagner, and I am the president of PA Lyme Resource Network, which is a 501(c)(3) in Pennsylvania providing outreach support and education and advocacy services to both the general public and the medical community in Pennsylvania. I have provided testimony as a background to all of you. It was provided in the PA Senate this past October. So please refer to that for more detail. I would like to make three comments, three points and this is all based on the experience of our organization with over 8 to 10,000 patients annually in Pennsylvania, and it represents their point of view and it also represents my point of view as a parent with three children afflicted by these diseases, and personally as someone who became dementia-like because of these diseases—and with appropriate advocacy by ourselves and access to resources reversed that and quite high functioning today. So with that said, the first point is that in argue the situation is quite serious. Pennsylvania, as you know, is number one in reported cases and continues to increase. The large percentage are children through young adults and what we have seen in recent years is extremely concerning and that is an increase in death count. Over the last year, we lost a 25-year-old, a 29-year-old, a 3-year-old, a 50-year-old, a 50-year-old with two young children, and a 39-year-old. All of these would not in any way be confirmed due to tick-borne diseases without the intervention of their families working with the coroners to make sure that the cause of death was reported. So, we are not in any way tracking deaths associated with tick-borne diseases in Pennsylvania, and I think this is key. The impacts are serious. This organization started by parents whose children were affected and saw neurological, cognitive, and psychiatric impacts that when properly diagnosed and treated were completely reversed. We all know that the roll-up of that in terms of quality of life, in terms of cost, societal cost, and individual cost is very high and if just a small percentage of some of these serious diseases can be reversed, it behooves us to take those actions. So in our view, the situation is very serious. Related to this is number two and that is that short-term action that in fact are low-cost are needed and are within your reach to shift the perception of this disease. In Pennsylvania, we are very focused on prevention and awareness programs and are funded by the Department of Health to want the first prevention program. We believe that the language about this disease needs to shift from it being benign to being potentially quite serious. That will allow departments of health to take action... (Audio cut off )
Phone Operator: Your next speaker is Beth Carrison-van der Heide. Go ahead, please. Your line is open.
Beth Carrison-van der Heide: Thank you for allowing the four Alpha-Gal advocates to comment today on behalf of the thousands affected by Alpha-Gal Syndrome (AGS) across the U.S. and worldwide. In the comments by Beth Carrison-van der Heide, Jennifer Burton, Tim Opiela, and Dr. Jennifer Platt, we’ll take this opportunity to share with you the concerns and experiences of the AGS community. We’ll present many significant gaps involving the Lone Star tick, which is associated with at least eight diseases and conditions identified by the CDC. The facts presented should be of keen interest to all here today, all of which are transferable to all of your six working group committees and their affiliations. Facts to consider: Lone Star ticks are found in over 1,300 counties and 39 states and growing in the U.S. according to the CDC. A 2017 report recorded in the U.S. National Library of Medicine confirmed Alpha-Gal IGE reactivity to Lyme, Borriello, and Xiodes Rickettsiosis. AGS is known to stem from six other ticks worldwide. This puts the U.S. citizens in our active Armed Forces at risk. The following highlights have far-reaching impact all stemming from AGS, which, again, remains unmonitored. That’s from social and economical consequences, U.S. healthcare system, education awareness, and treatment materials. Also the need for accurate FDA recording and labeling and the safe procurement in manufactured goods imported and exported worldwide. The potential for the spread of infectious disease due to our inability to participate in many vaccinations, liability and financial burdens to the public schools and employees since AGS is covered by the American Disabilities Act. Many children are at risk and many are currently experiencing daily reactions, including anaphylaxis, while at school due to exposure to simple items containing mammalian ingredients, such as glue, crayons, as well as airborne reaction to dairy, covered pizza, and beef burgers while they’re cooking in the school. The livestock industry is also affected since AGS households often eliminate all mammalian foods and products, including dairy and lastly, but not limited to, decreased acceptance in the U.S. and Armed Forces due to our inability to receive mandated vaccinations and the risk surrounding AGS. In closing, thank you for expanding the language here today, which will now include Alpha-Gal and other conditions in the discussions, research, and review of the working groups scope. For the record, I am diagnosed with both Alpha-Gal and Lyme disease, which were left undiagnosed for 15 years and 3 years, respectively. In both cases, I self-diagnosed before being properly diagnosed by my physician. My husband and my son both are affected by Lyme. *** (beeping sound - 01:36:39) reported with evidence to you in the email. Thank you.
Phone Operator: Your next public comment comes from the line of Jennifer Burton. Go ahead please.
Jennifer Burton: I was diagnosed with Alpha-Gal Syndrome after months of battling the common escalating symptoms of AGS—extreme fatigue, joint pain, rashes, vomiting, diarrhea, GI distress and bloating, angioedema, urticaria, and four anaphylactic episodes (two nearly fatal). I want to address the gaps in the medical, pharmaceutical, emergency services, and food industries not only for those of us with AGS, but for others afflicted by tick-borne illnesses. Gap: better education and resources for the medical industry regarding the 20 plus tick-borne illnesses and their symptoms; questioning patients that have been recently bitten by a tick; not doing so with patient’s lives, their quality of life, and results in months or years of improper patient, institutional, and elder care, medications, medical, and insurance bills, and personal financial losses. Once study sites 43 of those with AGS were self-diagnosed. Many are diagnosed with one tick-borne illness and then years later diagnosed with two or more. This is true for my patients with AGS and with AGS patients with latent Lyme. The majority of doctors send AGS patients away with instructions, “Just don’t eat beef or pork and it will go away in 2 to 5 years.” Current statistics show only 1 in 300 go into remission and, if bitten again, the reactions return and worsen. AGS is a tick-borne illness that is life altering and life-threatening with many adverse reactions, badly afflicting many children. Gap: education for first responders, paramedic and emergency room personnel, especially in anaphylactic cases. 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 byproducts. Gap: educating pharmacists. One article sites, “Pharmacists should be cognizant of patients presenting with anaphylactic systems and with a history of exposure to ticks,” but the majority of us adjusting meds and supplements containing gelatin capsules, lactose, whey, magnesium steroid, and other mammal sources keep our systems constantly agitated and has caused anaphylactic reactions. Gap: accurate and full disclosure of all ingredients in food labeling; for example, natural flavorings with spices which could contain mammal source ingredients. This alone would allow millions with food allergies and those of us who react with trace mammalian sources the ability to avoid it. Conclusion: there are many gaps, but the key for education, awareness, and prevention not only in the medical field, but throughout the general public; without those keys the number of people with the tick-borne illnesses and deaths will only increase exponentially just as tick and the pathogens they carry have. Thank you.
Phone Operator: Your next public comment comes from the line of Gary Sweeney. Go ahead please.
Gary Sweeney: My daughter has been stricken with Lyme for over 10 years. Our story is similar to many others presented here. Our healthy high school daughter experienced extreme fatigue, joint pain, and brain fog. Over months, many specialists were consulted. A positive IGM Western blot was dismissed as false positive due to durational symptoms. We were told by almost all of our doctors, Lyme does not exist in Georgia. A few doctors suggested psychiatric counseling. Almost a year into searching for a diagnosis, our daughter’s symptoms worsened. We went out of state for a doctor educated in diagnosing and treating Lyme. Initially, oral antibiotic treatment was followed by IV antibiotics for 6 months. After treatment, there was significant improvement, but it came at great monetary expense due to insurance denials. With often, occurrences of symptoms, our daughter earned *** (indistinct) despite symptoms and treatments affecting her, our daughter struggles to live as normalized as possible. Currently, she is in treatment for extreme fatigue. At times, life is difficult for our family. Experiencing life with a child who continues to suffer 10 years past diagnosis, I find myself with many pertinent and important questions regarding diagnosis, treatment, and the basic biology of spirochetes that I want to present to the ***, (indistinct) “Why are victims and their families told Lyme does not exist in non-endemic areas? Are black-legged ticks the only vectors for Lyme? What about Lone Star ticks? How do *** (indistinct) and changes in expression of outer surface proteins interact with the immune system? Is it possible the immune system is severely down regulates to allow viral and other biological opportunistic *** (indistinct) to thrive?” (Silence.)
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Phone Operator: And your next public comment comes from the line of Timothy Opiela. Go ahead please. Your line is open.
Timothy Opiela: Hello, and thank you for allocating this opportunity to speak to you about an emerging tick-borne disease known as Alpha-Gal. My name is Timothy Opiela. I’m from Pittsburgh, Pennsylvania. I’ve been researching and educating victims of venomous Lone Star tick bites for the last 7 ½ years, including parents with children with Alpha-Gal. My research commitment for Alpha-Gal stems from my daughter being bitten by a Lone Star tick, which gave her Alpha-Gal at age 6 in 2010. At that time, she was a healthy figure skating champion with Olympic dreams. An observation of the rapid geographical spread and sheer number of newly diagnosed Alpha-Gal cases, especially amongst children, I have to wonder, “Are we at the evolution, the cusp of the creation of a new Alpha-Gal generation of children?” As you may or may not be aware, Alpha-Gal is not limited to just ingestion of meats and/or byproducts. It’s much more pervasive and encompassing. The area I’d like to focus on is the impact of vaccines on children with Alpha-Gal. AG children are not able to be safely vaccinated for many of the recommended and required vaccines, because they are grown in mammalian product or byproduct, such as gelatin. A review of 61 vaccines deemed important by the CDC, 38 contain mammalian-derived ingredients, for many of them unsafe for children with Alpha-Gal. This means only 37% of the vaccines potentially safe to administer to a person with Alpha-Gal leaving unprotected and preventable diseases 63% of the time. Due to gaps in research and because Alpha-Gal children are not vaccinated, exposure to infectious disease will affect everyone here in the United States. Last year alone, our daughter, along with the sons and daughters of other people...kids with Alpha-Gal were not able to receive vaccines, such as HPV, Tdap, and meningitis. These are not vaccines we want to have administered to our children, but simply safely could not. By not being able to have a growing... By not being able to have a growing number of Alpha-Gal people vaccinated, gaps the infectious disease pathways and becomes an obvious risk for the general public. Alpha-Gal and Lone Star tick populations, such as in the Long Island, New York, Charlottesville, Lynchburg, Virginia, and Chatham County, North Carolina, with record numbers of Alpha-Gal cases become now breeding grounds for an increase of infectious disease potential both now and in the future. I request for this well-respected committee to include Alpha-Gal (beeping sound - 01:45:12) as part of the emerging tick-borne disease conditions and national efforts to prevent gaps of future spreading of infectious diseases. Thank you for your time, review, and consideration.
Phone Operator: Thank you, and as a reminder, for those, once you hear the alarm, there is 15 seconds remaining. Your next comment comes from the line of Jennifer Platt. Go ahead please.
Jennifer Platt: Thank you. I am the CEO and founder of Tick Warriors, a private company based in Chatham County, North Carolina. Chatham is a widely recognized hotspot for illness in both North Carolina and the U.S. In 2011, while I was working on my doctorate in public health from UNC, I contracted Ehrlichiosis and was later confirmed to also have Lyme and Babesia. In 2015, I worked with our local health department to conduct an exploratory survey about exposure to ticks. 94% of respondents indicated that one or more people in their household were exposed to a tick within the previous year. Subsequent surveys yield similar results. Our exposure in Chatham is more than doubled the national household exposure average of 45%, according to a 2015 CDC study. Tick-borne illnesses are not rare here, but we can’t track or validate the impacts of AGS and other “conditions,” such as STARI, heartland virus, and tick paralysis, because none of them have a specific ICD-10 diagnosis code. In the southeast U.S., five species of ticks bite humans, more than any other region in the country. At least 11 associated human pathogens have been identified. Any tick can cause paralysis. When patients are *** (indistinct - 01:47:02) to have at least one pathogen, more complete testing at all is desperately needed. I urge you to read the letter to the editor in this month’s CDC’s Emerging Infectious Diseases Journal, which discusses the spread of the Lone Star tick into the northeastern U.S. and raises more issues than I can address here. One critical issue is the complications of using the presence of EM to diagnose Lyme disease. There is the possibility that LD case numbers are inaccurate, because the Lone Star tick bite can also produce an EM. This may help explain why growing numbers of Lyme patients are discovering they react to red meat; clearly AGS goes way beyond problems with eating red meat. For many reasons highlighted, mis-diagnoses run rampant. As experienced by those with Lyme disease for decades, AGS patients are also invalidated by their health care providers and loved ones. The consequences: emotional, economic, social are devastating. Thank you for your decision to include AGS and other conditions in your report. For additional emphasis, you may want to consider expanding the charter language (beeping sound - 01:48:24) and vision statement to tick-borne diseases and conditions. I thank each and every one of you for your commitment to this initiative. We all bear the burdens of tick-borne illness and owe the full picture to ourselves, individuals, and taxpayers. Any less is not acceptable.
Phone Operator: Your next comment comes from the line of Jena Blair. Go ahead please.
Jena Blair: Hi. Thanks for having me on today. First off, I’d like to remind the working group that Borrelia or relapsing fever germs and just like the rest, they’re capable of antigenic variations. That fact alone makes it a ridiculous notion to attempt to vaccinate against it and asinine at best to say that vaccines for spirochetes work by turning human blood into tick-borne (?indistinct - 01:49:06) infestations. Secondly, OspA panthresis, (spelled phonetically) a fungal-like endotoxin that causes immune suppression and that means that it is the opposite of a vaccine. For the last 18 and half years the activist group Action Lyme and now Truth Cures has been filing complaints with every dot gov agency anyone can think of. This was even brought to the FDA formally that OspA causes immune suppression and a systemic disease *** (indistinct - 01:49:31) and I’m directly quoting here from a patent owned by David Pershing and Robert Schoen who say that OspA causes a disease indistinguishable from late chronic neurologic Lyme, but never once has any dot gov agency or MD answered the question as to how OspA allows the same exact multi-system protein disease, no spirochetes same disease. The science was settled as far back as 1986 when, for example, Paul Duray who is a top Army pathologist, reported that the lymphocytes in spinal fluid look like leukemia or lymphoma and appeared to be Epstein-Barr transformed. Also, in the 1980s it was Allen Steere himself who reported that this was like pseudo-lymphoma. Gary Wormser has reported that OspA causes immune suppression, three times now. So, do we really not know anything about relapsing fever organisms? Post-treatment Lyme disease syndrome or chronic Lyme, or whatever you want to call it is really an Acquired Immune Deficiency or what the NIH calls post-sepsis syndrome. Everyone says so. There is no question. Every subcommittee needs to be viewing the disease through the lens of this really being a B-cell 8. The only way forward is for HHS to admit the role of OspA as a self-disabler. OspA could have never been a vaccine; it never was and it never will be, because it is a fungal-like endotoxin. Spirochetal diseases are not easily treatable infections. They are acquired immune deficiency detonators with a cancer-like twist. We demand that you answer as to what the structure and function of OspA is and that alone will give you the foundation to squash all of the controversy. If this committee fulfills its intended purpose altruistically, you will look at the existing science to validate what is really going on with Lyme disease and you will recommend a criminal prosecution and stop the madness. TrueCure.org has all the data in our chart sheet. Thank you.
Phone Operator: And the line of Kathy Nodolf. Go ahead please.
Kathy Nodolf: Good afternoon. The biggest complaint I have about the crazy controversy regarding Lyme disease is the vehement denial of facts, truth, and the real science that exists today. There is only one truth, not tailor-made versions of it, to suit each and every one of us. This committee will have failed everyone if the U.S. government does not state for public record what exactly OspA is or Outer Surface Protein is and what its structure and function are. The answer to this will cut to the chase and answer all other questions. If we know what is a fungal endotoxin that causes immune suppression, then we can end this false dichotomy over persistence and antibiotics. Killing spirochetes is not the answer to this disease. There has been a crime committed here. The crime is a falsified case definition of Lyme disease. We demand prosecution of the individuals who are responsible for changing the case definition at the 1994 Dearborn Conference chaired by Barbara Johnson of the CDC and aided by Alan Steere’s research fraud used to falsify the case definition. This conference facilitated the approval of the science...of the since failed LYMErix vaccine, which has been pulled off the market for causing the same multi-system disease as those of us suffering from neuro-Lyme. OspA within the vaccine and OspA and other lypoproteins like it are shed with blebs or other exosomes by spirochetes. Spirochetes cause disease by going straight to the germinal centers of our lymph nodes; these are worked on by Nicole Baumgarth and Steve Bartell. The current testing makes absolutely no sense when you understand that Borrelia are relapsing fever germs. Borrelia is differentiated by their flagellum genes or DNA. Since all relapsing fever organisms are capable of antigenic variations, they can change their outer surface protein as a way of evading the host’s immune system. The only scientifically valid way to test for Borrelia infections would be to test for flagellar antibodies instead of outer surface proteins, because it is specific and it never changes. Testing for so many antibodies all at the same time is not logical or valid by any standards. Erol Fikrig and Flavell did a test in 1991 patent number 5618.533, which is 94 to 95% accurate during all stages of the disease. This is obviously the test that should be used. Until we get the correct definition of this disease, we will never find a cure. We have wasted too many years and too many dollars trying to fix a disease that is currently defined incorrectly by design. I am tired of watching my friends die and suffer a torturous life due to this crime. The insanity of it all needs to stop now. Go to TrueCures.org for the scientific validation needed to prosecute this crime.
Rich Wolitski: Operator, if we’re able to get Gary Sweeney back on the line, we’ll go ahead and give him 3 minutes to make his public comment over. It seemed liked maybe a technical difficulty caused him to get lost off the line.
Phone Operator: And Mr. Sweeney, your line is open.
Gary Sweeney: Thank you for allowing me to continue. Experiencing life with a child who continues to suffer 10 years past diagnosis, I find myself with many pertinent and important questions like diagnosis treatment and basic biology of spirochetes that I want to present to the group at this time. Why are victims and their families told that Lyme does not exist in non-endemic areas? Are black-legged ticks the only vectors for Lyme? What about Lone Star ticks? What methods do spirochetes employ to evade or disrupt the complement system? What are the interactions between spirochetes and toll-like receptors? Is it possible the immune system is severely down regulated to allow viral and other opportunistic infections to thrive? Why do the IDSA and CDC still rely exclusively on imprecise two-tier testing? What were the criteria for selecting which bands and the number of bands needed for positive Western blot? What about band specific for Lyme like the flagellar? If the immune system is compromised, it’s possible for bands not to show, but we currently test for multiple strains of spirochetes, or is that test for only one strain from the northeastern United States? What is the outlook for using PCR testing and testing to identify tick-borne co-infections? Was Dearborn valid and properly vetted by diverse scientific and medical communities? Why are patients routinely limited to only 2 to 4 weeks of antibiotics? How do physicians treat persistent infection without fear of license revocation and professional persecution? Why does the Detweiler study remain the gold standard employed by the IDSA for unlimited treatment recommendations so it be subject to renewed scrutiny? For far too long, victims of Lyme and their families have struggled to find and pay for treatment. For far too long, groups have talked over, around, and against one another presenting their guidelines for treatment and diagnosis of tick-borne disease; meanwhile, victims suffer and the disease spreads. Lyme has emerged as the number one reported vector-borne disease in our country, but flags and funding levels commensurate with this ranking. United efforts to provide information about tick-borne diseases, to provide effective diagnosis and treatment, and to enact preventative measures needs to receive the utmost attention. Victims of tick-borne diseases deserve no less. Thank you.
Rich Wolitski: That ends our public comment period. So, we’ll move on to the next item on the agenda. Thank you everybody for taking time to share your experiences and thoughts with us. We appreciate it.