TBDWG February 12, 2018 - Written Public Comment
All Tick-Borne Disease Working Group (TBDWG) meetings dedicate time for public comments. The Working Group invited public comment on issues related to the Working Group's charge. Verbal comments were provided over the phone during the meeting. Written comments were submitted via email to the TBDWG inbox. Below are the written comments submitted by individuals for the February 2018 meeting.
We need unbiased representation in all chairs of the Tick Born Disease Working Group (TBDWG). Replacing Wormser with someone who shares the same IDSA, old scientific views is shocking, disappointing and of no help to the Lyme community at large.
We the People of the Lyme Disease patient group will not allow our chance to be helped and represented by the work of the TBDWG go squandered by the biased representation of Robert P. Smith and the like. His views are no better than Wormser's views. Over 700 validated and peer reviewed studies prove that Lyme cannot be killed by the current marketed treatment guidelines of IDSA, Dr. Smith, and the CDC with a short month of antibiotics. Over 700 peer reviewed articles showing persistent Lyme for your reference http://www.ilads.org/ilads_news/wp-content/uploads/2017/02/CLDList-ILADS.pdf.
Dr. Smith is listed as a member of the "Ad Hoc International Lyme Disease Group" that co-authored Critical Appraisal of Chronic Lyme Disease Article- NEJM along with Wormser. Click the link to understand better his ability to misunderstand persistent infection rather than the fictitious Post Lyme Disease Syndrome he inaccurately spouts http://www.nejm.org/doi/full/10.1056/NEJMra072023.
Dr. Smith has also stated “standard antibiotic treatment regimens are highly effective” https://www.ncbi.nlm.nih.gov/pubmed/16407609. Sir/Ma’am, I have successfully treated 5/5 Lyme sufferers to remission and have a few filing cabinets full of proof that this is old science and ineffective ideology. I had done weeks and weeks of antibiotics prior to the births of my children, my diagnosis in 2012, and still gave birth to 4 positive Lyme kiddos. More information can be provided but here’s a start of proof as to persistent and chronic Lyme infecting generations to come if you do not change your bias to old IDSA guidelines and those who share the same beliefs as Wormser, Dr. Smith and their misrepresentation of post Lyme disease syndrome.
Borreliosis Infection during Pregnancy
- Infection with Borrelia: Implications for Pregnancy – (e-chapter) http://www.smgebooks.com/lyme-disease/chapters/LD-17-05.pdf
A few key points from second publication:
- 'Gardner and other authors have conclusively shown that certain individuals infected with Borrelia acquired their disease gestationally. This is further supported by the finding of Borrelia in semen and by the similarity to which Treponema transmission has been abundantly documented in the literature.'
- 'Transplacental transmission has been clearly documented from case reports of infected fetuses'
- 'Complicating diagnosis even more, as previously displayed via case reports, serologic testing of mothers in post-partum period and their neonates is often negative.'
- 'It has been demonstrated that over 70% of neonates that have tissue verified borreliosis at the time of delivery, will NOT produce antibodies in sufficient quantity to be diagnosed as sero-positive.'
- 'Negative serology in the infant does not necessarily rule out the risk of congenital infection, since the majority of infants will indeed screen negative.'
- 'Transmission of Borrelia infection occurs via both zoonotic vectors AND other humans.'
- 'Congenital transfer is an established fact, and animal data in conjugation with other data support that sexual transfer can also occur.'
- 'Maternal to fetal transfer of Borrelia can furthermore be clinically silent or unrecognized, and if not successfully treated, infection can be life long, and latency, late activation and reactivation can occur.'
Author lists several points which are evident from the review of current literature:
- lack of tissue inflammation seen in tissues with evidence of spirochetes.
- significant discrepancy in maternal serology testing (serology often negative in mothers)
- positive cultures of spirochetes from fetal organs
- effects of infection during the first trimester with cardiac organogenesis
- fetal growth restriction
- mothers infected in 'non-endemic areas’
If Lyme patients were truly "cured" by standard antibiotic treatment, would we even need a working group? How can we move the discussion forward if a working group member refuses to even acknowledge the growing mountain of credible research proving persistent infection after antibiotic treatment? Thank you for your time and this petition may save the life of a loved one, or your own by getting an unbiased person to fill the chair of Dr. Smith and Gary Wormser. We deserve better!
Please let me know who I can speak with that continues to elect such bias candidates to chair this committee.
Thank you, Kristina Bauer, Lyme Warrior and Mom of 4 with Gestational Lyme
[Additional comments by Kristina Bauer]
- All participants of the TBDWG should take an oath on the constitution, not the Bible to follow the most current science provided equally by all sides. If it's been peer reviewed and validated by equally credible peers, it has to be allowed in the mix of information that will steer the group. Diversity is great providing all members of the committee are all playing on the same playing field, meaning acknowledging the most current data decided eligible by all equally. Half the group shouldn't discount credible science of persistent Lyme and half the group not. That is not conducive for helping Lyme patients.
- No one can participate that have received grant money from tax payers, of any kind like Beard and Smith have for instance! Conflict of interest plain and simple and not tolerated. Everyone else plays by these rules, they need to too. We need truly unbiased opinions who aren't tied to financial gain.
- Do all 14 members have equal voting power? Do all subcommittees have equal input to that voting power to make decisions? Who at HHS supersedes, if any, the direction and decisions arrived at by the TBDWG? We want complete transparency to all contacts made to obtain how the group was formed.
- If the Group fosters the use of Lyme vaccine in the future we the patient Group or subcommittees, need complete transparency in their answering whether that vaccine has undergone strict efficacy and safety tests in a double blind placebo study or it should be banned from production. Lyme changes constantly and therefor can't be vaccinated against OspA. There are better methods like homeo, LDI, and prevention tactics with no side effects. Stricter than testing a pharmaceutical drug due to potential risks currently existing today prior to getting any vaccine.
I am honored to serve Lyme patients in the best capacity possible and submitted my resume for a subcommittee election.
Thank you for your time and consideration,
I am activist, because I can’t simply just be sick with Lyme disease.
I, like many others, am forced to fight for the truth to stop being covered up instead in an effort to prevent us from being buried alive with it. This is a crime scene, not a mere controversy. The science has been settled since the 1980s that this is a serious disease and;because of greed we seem to have went backwards.
It is my understanding that members of the organization TruthCures met with Mr. Wolitski in October of 2017 and they explained this to him in detail. I will briefly explain the generalities for other members who may not yet know.
Patients can’t just be patients if they have Lyme disease because of this scientific fraud crime that was committed 23 years ago. Both the testing and the case definition of the disease were changed to fit patent owners and members of the ALDF’s vaccine model. First they changed the testing (Allen Steere in Europe, 1992) to exclude all of the chronic neurologic cases in the first step with the ELISA. Then at the 1994 Consensus Conference in Dearborn, Michigan, they changed the very definition of the disease to only include the arthritic knee outcome.
You see, there are two outcomes to Lyme disease. One is an HLA-linked (or genetically linked) hypersensitivity response to spirochetes. These patients have high antibody concentration and these are the patients who test “CDC positive”. Only 15% of the population has the genetic predisposition for this outcome. This and only this is what“Lyme” disease means since 1994. The other 85% of total cases get immunosuppression and have low antibody concentration. They will never get past the ELISA for the privilege of having a Western Blot run. It has been proven over and over that the sickest patients have the lowest antibody concentration.
Following is a description of an image of three Western blot strips for Lyme disease.
“Shown are 3 western blot test strips for Lyme disease. Western blots are designed to diagnose disease by detecting antibodies to specific antigens. If there is a reaction, it appears as a darkened area on the strip, according to molecular weight. Reactions to multiple antigens will appear as multiple darkened areas, and stronger reactions will appear as darker blots.
The image shows the difference in how Western Blot results appear between the two genetically linked responses to spirochetes. There are two sets of Western blot strips that are both considered positive for a Lyme disease infection. One set of strips is labeled “Neuroborreliosis Stage II” and the other is labeled “Arthritis and Acrodermatitis”.
The two Neuroborreliosis Stage II test strips for IgG and IgM antibodies are very light indicating a weak immune response with very low antibody production. It is noted that 85% of the population gets this weak immune response in reaction to spirochetes. The Arthritis and Acrodermatitis test strip for IgG antibodies is very dark indicating a very strong immune response with high antibody production. It is noted that only 15% of the population get the strong immune response in reaction to spirochetes.
Notes written on the image by Kathleen Dickson read as follows: “All of this [the Neuroborreliosis Stage II and the Arthritis and Acrodermatitis Western blot strips] used to be Lyme Borreliosis or Lyme disease. Once the patented OspA product, the vaccine, was underway, “Lyme disease” became only the arthritis. The people with neuroborreliosis were then told they were just plain nuts, when, in fact, borreliosis is a disease of the brain."
This image was handed to the U.S. Department of Justice in 2003 as part of the complaint filed by the LYMErix whistleblower, Kathleen Dickson. Ms. Dickson is a trained Analytic Chemist who worked for Pfizer for 10 years as a Validations Specialist. She is qualified to know something about validity and it became;obvious to her that something was very wrong with this Lyme disease debacle.
What I really want to stress though is what we learned from the LYMErix vaccine. This crime was committed for the sole purpose of qualifying the vaccine. If 85% of the cases didn’t exist anymore they could say that LYMErix was at least 85% effective. It really is that simple. We are all familiar with the vaccine being taken off the market via ultimatum by the FDA because it was making people sick. Still, they insisted the only possible adverse event was an HLA-linked arthritis. In reality the vaccine was causing the same multi-system, protean disease that we are all catching from ticks and that is because OspA is Pam3Cys, a fungal-like endotoxin that causes immunosuppression. That means it is the complete and polar opposite of a vaccine. If OspA caused the same disease, without spirochetes, then what is the disease?
If this Working Group wants to help patients, who are actually victims, you all need to do one simple thing- help us bring to light the truth about why so many are disabled and tortured to death after a tick bite by recommending a criminal prosecution. Realize that everything that has been done since 1994 is a cover-up and based on research fraud. Look at the science that explains why so many are suffering, this is not mysterious. This is an acquired immune deficiency disease (AIDS), just like the sky is unchangeably blue. The truth is not going away and when history looks back it will reveal who was complicit in the murder of millions innocent people and who had integrity. All of you have a lot of lives looking to you for hope and a future where they will be validated. So validate them. Better yet, use what is already available and vindicate them.
Let’s not waste another second, another dollar, another life, going around in circles with the same tired arguments that have been perpetuated for the last 40 years. Children play outside and get tick bites often. We are obliged to hold ourselves accountable and act with integrity for their sake. Please, answer the question “If OspA vaccination alone caused the same multi-system chronic neurologic disease, then what is the disease?”. Mr. Wolitski has the advantage of already knowing the answer, I know a few others sitting at the table should be able to answer as well.
Do the right thing.
Beth Carrison-van der Heide
Hello and thank you for considering my concerns.
I am greatly concerned that Alpha-gal Allergy Syndrome has been “tabled” in these discussions.
Having been misdiagnosed with Lyme disease for 3 years, and then Alpha-gal for 15 years and suffering daily unpredictable reactions ranging from burning skin, hives, and anaphylaxis, I am gravely concerned about the “Access to Care Services and Support to Patients”. I am equally concerned that the consideration for “Pathogenesis, Transmission and Treatment” for the possible co-infections, reasons and subsequent lingering medical challenges I face, along with thousands of Americans and individuals worldwide.
I strong urge your committees to embrace this part of the Lone Star tick legacy, as part of your discussions. Here is why,
- Because it fits the Oxford definition of “Disease”. Oxford Definition of “Disease” - (please note carefully words in CAPS). Oxford definition of “Dis-ease”: 11A DISORDER OF structure or FUNCTION IN A HUMAN, animal, or plant, especially ONE THAT PRODUCES SPECIFIC SIGNS OR SYMPTOMS or that affects a specific location and is not simply a direct result of physical injury.
Synonyms: 1. 1.1 A PARTICULAR QUALITY, habit, or disposition REGARDED AS ADVERSELY AFFECTING A PERSON OR GROUP OF PEOPLE.
- Because it is the “responsibility” of the Working Group’s charter, under the 21st Century Cures Act to address this as a “ (2) (iv) gaps in tick-borne disease research described in clause (iii)(II).
It is widely known that the following stems from the Lone Star tick.
Work Plan Development
|Vector Tick||Pathogena||Disease in Humans|
|Lone star tick (Amblyomma americanum)||Ehrlichia chaffeensis||Ehrlichia chaffeensis infectionb|
|Ehrlichia ewingii||Ehrlichia ewingii infection|
|‘Panola Mountain Ehrlichia’||Ehrlichiosis, human, undetermined|
|Rickettsia rickettsii||Spotted fever rickettsiosis|
|-||Southern tick-associated rash illness|
|-||Red meat allergy|
You may also consider the following 2003 report found at the US National Library of Medicine National Institutes of Health, which clearly indicates how “Lone Star ticks harbor or vector several other pathogenic bacteria”. Reminder: Alpha-gal Allergy Syndrome was not discovered until 2008 by Dr. Platts-Mills, so it makes sense why this was not listed here.
Report: Ehrlichia chaffeensis: a Prototypical Emerging Pathogen; Christopher D. Paddock* and James E. Childs; Copyright 2003, American Society for Microbiology. See “Dual infections”
Lone star ticks harbor or vector several other pathogenic or potentially pathogenic bacteria including the spirochete “Borrelia lonestari” (22, 44, 140), Francisella tularensis (132), various spotted fever group rickettsiae (118), and E. ewingii (282). Descriptions of patients with simultaneous HME and Lyme disease (3, 27, 220) require cautious interpretation (27), particularly because the lone star tick is not a competent vector of Borrelia burgdorferi (217). However, in states where populations of A. americanum may be sympatric with I. scapularis, antibodies reactive with E. chaffeensis have been detected in patients with well-documented erythema chronicum migrans (176), suggesting that patients with Lyme disease may be exposed simultaneously or sequentially to other tick species carrying E. chaffeensis or other antigenically related ehrlichiae.
I believe the above is reason for doubt or “gap” in your research!
Another report to consider:
Beyond Lyme: Aetiology of Tick-borne Human Diseases with Emphasis on the South-Eastern United States
Authors - E. Y. Stromdahl,G. J. Hickling
First published: 7 September 2012
An important consideration for healthcare professionals is that the bite of A. americanum is associated with the development of southern tick-associated rash illness (STARI), a Lyme disease-like syndrome of unknown aetiology that is well documented in the south-east (Masters et al., 2008) and emerging (but likely under-diagnosed) along the Atlantic seaboard (Feder et al., 2011, 2012). Bites of A. americanum also have been associated with food allergy; some tick bite victims develop an IgE antibody response, presumably to compounds in tick saliva, that later triggers anaphylaxis or urticaria when red meat is consumed (Commins et al., 2011). An oligosaccharide (alpha-galactose) is present in the tissues, muscle, fat and blood of non-primate mammals, and eating their meat creates a risk for anaphylaxis in individuals who have acquired a tick bite-induced IgE response to alpha-galactose.
A related allergic response, perhaps to another component of A. americanum saliva, is one possible explanation for the symptoms seen in STARI patients.
Areas where rash-associated tick species overlap
In recent decades, the range of A. americanum has expanded northwards along the eastern seaboard and population abundances are climbing in several north-eastern states (Paddock and Yabsley, 2007; and references therein). Northern cases of STARI can therefore be expected to increase in Lyme disease endemic areas. In aggregate, there are differences in the clinical presentation of groups of patients with STARI versus Lyme disease (Wormser et al., 2005b), but it can be impossible to distinguish the EM-like skin lesion of STARI from that of Lyme disease for a particular patient (Feder et al., 2011). This creates the potential for diagnostic confusion in states where both I. scapularis and A. americanum are becoming abundant.
Three species of Ehrlichia– transmitted by A. americanum, E. chaffeensis, E. ewingii and PME – are known to cause human disease (Table 1).
Failure to correctly diagnose and treat ehrlichiosis (which with prompt antibiotic therapy normally resolves) can result in deaths of healthy young individuals (e.g. Martin et al., 1999; Rooney et al., 2001).
Recent treatment recommendations have begun to emphasize the importance of considering the tick species and its infection status as part of the diagnostic process (e.g. Hojgaard et al., 2008; Feder et al., 2011). Even so, there are clinical presentations after A. americanum tick bites that have yet to be associated with specific aetiological agents, and there are A. americanum-borne organisms whose pathogenicities are yet unknown. Consequently, healthcare providers and researchers need to remain open to the possibility of other as-yet-unidentified disease agents and cross-reactive agents, and there is a need for more thorough characterization of the pathogens involved in unusual or unexpected disease cases. IBIS technology (Crowder et al., 2010) and other novel techniques show great promise on this front.
Improving health provider knowledge of tick species distributions, and of tick-borne diseases other than Lyme disease, would lead to better diagnosis, treatment and reporting of these diseases, particularly in the south-eastern United States.
Thank you once again for all you are doing. The reports and articles are endless. The stories are devastating, along with the number of Americans being diagnosed and suffering unnecessarily. Something better has to be done. I urge you to PLEASE HELP US - and you, by including this in your research! This can happen to you as well, just as easily. (I had zero health issues prior to this.)
Living with Lyme is challenging enough, along with multi food allergies in our home, across 2 children and 2 adults. But, living with Alpha-gal is by far the most complex as it is NOT just the mammal meats we have to avoid. Many have extreme sensitivities that have altered the way we live in every single aspect of our lives. From foods, beverages, personal care, and medical care - seemingly everything contains hidden traces of mammal. (IE. IV Bags containing gelatin, products with glycerin (mammal/animal derived), magnesium sterate (some mammal/animal derived), perfumes/colognes ,"natural flavorings" which often contain mammal/animal ingredients, adhesives (think stamps, tape, band-aides) - the list is endless! As you can image, this is a severely life altering problem. I passionately urge you to reconsider and include this as part of your committees focus.
FYI: I am currently residing in Chelmsford, Massachusetts and Shapleigh, Maine, where I encounter Deer and Dog ticks constantly and now the Lone Star tick! I am formerly a resident of Kansas and Kentucky where I originally encountered the Lone Star tick years ago.
Beth E. Carrison-van der Heide
Integrative Nutrition Health Coach, INHC
Thank you for the opportunity to share in the exchange of knowledge, thoughts, and all matters relating to tick borne diseases. I joined this group to learn about mycoplasma, co-infections, Borrellia/Lyme, and immunosuppression. Hopefully accurate testing of mycoplasma, Lyme, and coinfections will become widely available and covered by health insurance. Like Lyme, mycoplasma seems to reactivate infections like Epstein-Barr, CMV, HH6,& the rest of the human herpes viruses. Please develop a query to look deeper into reactivated viruses, immunosuppression, and how Lyme relates to these factors. These illnesses are causing Post-Sepsis outcomes. The disease mechanism of Lyme is wrong. It appears to be OspA and a Pam3Cys. Not only is mycoplasma able to avoid detection by conventional labwork, but so is Lyme. This should change in a first world country as great as America. So many people in our country are suffering and need us to do something spectacular. Let’s help heal America! So many people in America are seeking answers and its time to show them the truth.
Thank you for allowing me to participate in the Tick Borne Disease Working Group. I look forward to building relationships with you in the future.
This testimony will provide information on potential barriers to progress within NIH and CDC programs for tick-borne diseases.
Bruce Fries, President,
Patient Centered Care Advocacy Group
2012 U.S. Senate Hearing on Lyme Disease: A Comprehensive Approach to an Evolving Threat
TESTIMONY SUBMITTED BY LORRAINE JOHNSON, JD, MBA, EXECUTIVE DIRECTOR OF LYMEDISEASE.ORG
A Federal Failure in Lyme Research, Guidelines, and Accountability: CDC and NIH Allow Private Interests of the IDSA to Set Federal Agenda in Lyme Research and Dictate Lyme Policy without Oversight
The government has an obligation to represent the interests of the public, to act impartially in an open and transparent manner, and to be accountable for its actions. Disturbing new facts obtained in a Freedom of Information Request filed by Kris Newby, the investigative reporter who produced Under Our Skin, reveal that an ad hoc group composed of members of the Infectious Diseases Society of America (IDSA), a medical specialty society, along with members of the Centers for Disease Control & Prevention (CDC) and the National Institutes of Health (NIH), has been acting in violation of fundamental principles of ethics. This group has been covertly setting government Lyme policy, intentionally excluding other stakeholders, running afoul of government open meeting standards, and deliberately subordinating the public interests to those of a private medical society.
The group’s actions have resulted in implementation of faulty public health policymaking and have damaged Lyme patients throughout the nation who suffer from severely restricted access to care as a result of these policies. Their actions have also resulted in favoritism in Federal grant funding and suppression of the innovation critically needed by Lyme patients for improved diagnostic and treatment options. These acts of commission and omission represent serious breaches of the public trust and undermine the integrity of the scientific research agenda. The CDC and NIH have essentially abdicated their healthcare policy determinations to a Quasi-Governmental Lyme Organization, dominated by a private medical society with no government accountability or oversight.
According to copies of emails released pursuant to a FOIA request (Newby 2012), a rogue group of IDSA researchers and government officials formed an ad hoc organization in 2005, shortly after a meeting of members of the U.S. Department of Health and Human Services, the Public Health Service, CDC, and the National Center for Infectious Diseases/Board of Scientific Counselors (NCID BSC) held on May 12 and 13, 2005 in Atlanta, GA. (NCID BSC Minutes.) According to minutes of the NCID BSC meeting, the group was attended by 31 CDC/NCID staff members (12 of whom were IDSA members), 10 BSC members (6 of whom were IDSA members), 4 ex-officio members (3 of whom were IDSA members) and 3 Liaison Representatives (1 of whom was an IDSA member).
Notable among the attendees were Lyle Peterson, director of the Division of Vector-borne Infectious Diseases (DVBID) and IDSA president Walter Stamm, who raised an alarm about a competitor organization, the International Lyme and Associated Diseases Society (ILADS), whose Lyme guidelines had just been listed on the National Guidelines Clearinghouse. This government meeting then determined that ‘‘CDC researchers should focus on science and not on the concerns of patient groups; other groups may need to step in and assist DVBID with public interface.’’ Action items from NCID BSC meeting included updating IDSA guidelines, updating CDC guidelines for interpreting laboratory tests, and notifying physicians and other practitioners regarding availability of clinical and laboratory documents.
That same month a private conference chaired by Dr. Gary Wormser (who also chaired the IDSA Lyme guidelines) was held at Westchester County Medical Center. According to one member, Dr. Susan O’Connell, the goal of the group was to ‘‘counteract misinformation from groups such as ILADS, unorthodox laboratories and support groups.’’ At the meeting a ‘‘work plan’’ was established that included a mixture of private interest and public policy issues:
- Updating IDSA guidelines (Wormser 2006).
- Critical appraisal of ILADS guidelines (Phil Baker NGC & Susan O’Connell’s ‘‘Independent Appraisal and Review of ILADS 2004 ‘‘Evidence-based guidelines for the management of Lyme disease’’).
- Critical appraisal of chronic Lyme disease (NEJM article) (Feder 2007).
- Facts and Fiction about Lyme disease.
- In-house tests commonly at variance with standard diagnostic methods (IGeneX NYDOH investigation; Susan Wong of NYDOH is a member of the group).
- Research needs.
- 2nd Banbury conference on serodiagnosis of Lyme disease to be held Sept. 2007 Surveillance definition modifications.
No public notice was given and the meeting was clandestine. The participant list for the meeting, chaired by Dr. Wormser included principally IDSA researchers and CDC employees: Drs. Zemel, Fish, Bockenstedt, Munoz, Dumler, Steere, Barbara Johnson (CDC), Shapiro, Strle, Stanek, Bakken, Halperin, Klempner, Baker, Krause, Dattwyler, Nadelman, Fingerle, Weinstein, Wilske, McKenna, Mead (CDC), Feder, Artsob, Schwartz, Green, Nowakowski, AgueroRosenfeld, Morshed, Auewaeter, Baker, Smith, O’Connell, Sood, Wong (NYDOH), Draper. (See Attachment A to this submission.) Shortly after that meeting IGeneX lab was investigated pursuant to a complaint filed based on concerns with its laboratory interpretation method. (Susan Wong, a member of the group worked for the NYDOH which launched the investigation against IGeneX.) A second clandestine meeting, also chaired by Dr. Wormser, was held on January 15th and 16th, 2007 at Westchester Medical Center.
This group, which subsequently added two members of the NIH, Drs. Phil Baker and Ed McSweegan, to its membership ranks, proceeded to work on IDSA projects and government policy projects regarding Lyme disease.
- During the course of the FOIA period, the group:
- Developed and published the IDSA guidelines;
- Secured the listing of the IDSA guidelines on the National Guidelines Clearinghouse;
- Lobbied the National Guidelines Clearinghouse to delist the ILADS guidelines from the site;
- Authored and published an article in the New England Journal of Medicine defending the IDSA guidelines;
- Worked to launch an investigation against a major Lyme disease diagnostic company, IGeneX;
- Orchestrated the Second Banbury conference on serodiagnosis held in September 2007 (Barbara Johnson of the CDC, Dr. Phil Baker of the NIH, and Dr. Ray Dattwyler of the IDSA organized it.); and
- Sought surveillance definition modifications.
Throughout the 2 years of emails circulated among the Quasi-Government Lyme Organization, three things are clear. First, there was no dividing line between the private enterprise interests of the IDSA, a medical society, and those of the public or the government. The anticompetitive agenda of the IDSA Lyme researchers was adopted unquestioningly by the CDC and NIH as their own. Second, neither the CDC nor the NIH exercised impartiality or sought the views of IDSA’s competitors, patients, or the public in making its public policy determinations regarding the IDSA and its competitors. Third, the public and the IDSA’s competitors were excluded from the meetings and communications. The group included government employees who worked to pursue the IDSA’s interests. Specifically, government employees reviewed IDSA guidelines drafts, helped get them listed on the National Guidelines Clearinghouse, worked to delist the guidelines of IDSA competitor ILADS, reviewed drafts of the NEJM article, referred the NEJM article to the CDC press office to ensure that it was publicized, had the CDC press office request open access publication of the NEJM article from the publisher, and worked with a private IDSA researcher and grant recipient to host a scientific conference that would determine a research agenda and inform funding decisions.
U.S. Senate Hearing, Lyme Disease: A Comprehensive Approach to an Evolving Threat
PREPARED STATEMENT OF KRIS NEWBY
CDC Allows Commercial Group to Set Lyme Disease Policy and Funding Without Transparency or Oversight
In early 2005, leaders of a commercial medical society formed an ad hoc group of 26 members whose initial aim was to discredit and remove a competitive set of Lyme disease treatment guidelines from the National Guidelines Clearing House.
This ‘‘Ad Hoc International Lyme Disease Group’’ convened during government funded, closed-door meetings and had members who were researchers with significant commercial interests in Lyme disease tests and vaccines; CDC and NIH government officials; and foreign nationals. This group set Lyme disease policy and a national research agenda without public oversight or transparency, and subsequently, a large percentage of government grants were awarded to its own members.
Part of the group’s stated mission was to run a covert ‘‘disinformation war’’ to ruin the reputations of the patients, physicians, and journalists who questioned the group’s research and motives.
These findings, and more, were recently revealed through a Freedom of Information Act request filed by the producers of UNDER OUR SKIN, a documentary about the politics and commercial interests surrounding Lyme disease. The Centers for Disease Control (CDC) took almost 5 years to fulfill this request, which included 1,400 pages of emails sent between the CDC, the NIH, and authors of the Infectious Diseases Society of America’s Lyme disease guidelines.
A number of improprieties were revealed in the CDC and NIH emails released in the FOIA request, including evidence that Ad Hoc International Lyme Disease Group members:
- Disproportionately received about a third of all Lyme-disease related government grants, at the same time several CDC and NIH employees associated with Lyme disease research were members of the Ad Hoc group. Since 1991, just 5 Ad Hoc group-affiliated organizations received more than $88 million in government research grants.
- Allowed a researcher who owns a company that markets Lyme disease tests and vaccines to organize a CDC–NIH-sponsored meeting where Lyme disease government funding strategies were being determined. Shortly after he organized this meeting, his company’s government grant total approximately doubled, to over $2M per year.
- Used their government positions to try to remove a competing medical society’s Lyme disease studies and guidelines.
- An NIH employee used his government credentials to orchestrate a ‘‘disinformation war,’’ through anonymous tips, blogs and press leaks, against physicians and researchers who seek to publish scientific findings that contradict those of the IDSA guidelines authors.
- Used their government titles and positions to block patient-backed Lyme disease legislation.
In summary, these newly disclosed emails show that the Ad Hoc International Lyme Disease Group, which is enabled by employees of the CDC and the NIH, has been operating outside of government regulations on transparency and public accountability for years. It appears to be steering millions of dollars of grants to group members, and it covertly has been trying to tarnish the reputations of patients, researchers and journalists who disagree with them, using their improper relationships with government employees.
I urge Congress to further investigate this matter so that scientific research on Lyme disease can proceed without the undue influence of commercial interests.
To whom it may concern:
I have had Lyme Disease since 1969 when I was 1st misdiagnosed for the next 35 years by 40-50 drs! UNACCEPTABLE!
- I've had chronic Lyme for 48 years last Christmas!!
- My 1st wrong misdiagnosis was mono, the kissing disease.
- Since then, it's been chronic fatigue, fibromyalgia, irritable bowel/bladder, migraines, GERD, restless leg syndrome, and the list and symptoms are over 150!!
- I was correctly diagnosed June 2004 after CDC positive from IGENEX LAB, Palo Alto, California.
My late husband's brain, Jack Gordon, made WORLDWIDE HISTORY showing 2 diseases never found before from Dr. Alan MacDonald, retired pathologist from Florida:
- LEWY body dementia causing Jack visual & very VIOLENT hallucinations like Robin Williams had!
- found also a filarial NEMATODE PARASITIC WORM THAT HAD LYME INSIDE IT TOO.
- Alan also told me that I would be the 1st CO-AUTHOR over the 3 medical people involved in these results.
- recently another lab from UNIV. OF MINN. under direction of MARNA ERIKSON was found also to have BARTONELLA !!
- Marna has sent his brain tissue slides to 2 more labs in Duluth, Minn. and Galaxy lab in NC for testings.
- I am working with Marna to get Jack's discoveries PUBLISHED in a scientific medical journal to educate everyone!!
- Alan's health got worse after these discoveries and he was unable to write up HIS part to send it for publishing.
After getting Marna's and 2 other labs results, I then have to go to court for:
- COURT ORDER FROM JUDGE TO AMEND JACK'S DEATH CERTIFICATE, DC.
- plus getting Jack ADDED TO IOWA'S CDC LYME STATISTICS!
- The MD signing Jack's DC didn't feel comfortable changing it since it was 1 yr. after Jack died.
- Iowa's director over death certificates told me a COURT ORDER was needed due to time lapse.
- Trying to find out WHO needs to AMEND Jack's DC took me 2 years of my time, frustrations, and STRESS since everyone was giving me the run-around and not returning emails in 6-9 months!!
- plus the extra $$ from me to pursue getting the CORRECT info on Jack's DC that CONTRIBUTED to his death vs. lung cancer diagnosed 2 nights before he died !
PRIORITIES SHOULD BE THE FOLLOWING:
1. Sound science.
Persistent infection is a very simple theory, despite the fact the mechanisms by which Bb evades current treatment protocols may be complex.
- Proposed non-infectious post-treatment theories of persistent Lyme Disease are highly speculative, and propose complex etiologies of unknown basis.
- Such complex theories therefore, require overwhelming proof to even be considered over persistent infection.
Lyme research funding should be based on this scientific reality.
- Substantial evidence already exists for persistent infection, and considerable research exists on how Bb evades antibiotics and the immune system.
- Accordingly, we need not make further "proof" of this theory a priority, but to look at how better treatment outcomes can be achieved.
2. Sound Testing.
- Decades ago current serology-based based testing was proven to be inadequate for clinical purposes.
- In the year 2018, the poor performance of these tests would never be considered acceptable for an emerging disease.
- Therefore, such testing must not be used as the entry criteria for Lyme research.
- Use of such a poor testing methodology creates a sub-set of patients in subject pools, and therefore limits the applicability of the results of such studies.
- This can also, and does, result in circular logic in some past research.
Therefore, the number one priority for Lyme Research is the development, identification, and validation of better Lyme testing.
- Until such time as this occurs, Lyme studies must rely on alternative methods of identifying subjects, so as to avoid the known problems with serology-based tests and the resulting suspect study subject populations.
3. Long term studies.
- Current research dollars would be well spent to do follow-up studies on patient subjects from previous studies.
- This would allow the fastest access to data on the long term consequences of Lyme Disease.
- Funding for new long-term studies are badly needed as well, but these will not produce results in the short term.
- "Big Data" studies are yielding results and should be publicly funded.
One model for Lyme disease is that of Syphilis.
- Understanding of that disease was extremely limited until long-term studies were performed.
- It is crucial that such long term studies be begun as soon as possible.
Further development of the Syphilis model of Lyme Disease may also prove valuable with regards to better treatment, since it is also difficult to treat.
- Currently fashionable short-term treatment regimens may be duplicating the tragic "Tuskegee Experiment" that taught us how severe tertiary syphilis can be.
- Avoidance of such tragic results should be paramount on the minds of public figures including this body.
4. Recognition of the Lyme Epidemic and Appropriate Funding.
- The CDC and NIH are not protecting the public from this widespread epidemic.
- The sheer numbers of patients with "lingering symptoms" every year are staggering (estimated to be significantly in excess of 10 thousand every year).
- Such a public health emergency requires action. Research funding must reflect this reality.
Thank you for your time.
I am co-founder of TRUTHCURES, the only science-based Lyme activist organization in existence.
TRUTHCURES exists for one reason, and one reason only: Because all attempts at Lyme advocacy in the last 40 years have failed, and I dare say that most organizations revel in their years or decades of failure as a sick kind of celebrity status symbol.
There is a reason nonprofits are required to have a dissolution plan; because there is an inherent expectation that they will accomplish their mission and then dissolve. Nonprofits are not supposed to be forever. They are not meant to be personal profit vehicles for their directors, nor bank accounts for their mob associates. Suspicion should be cast upon nonprofits that tout their many “accomplishments” but have done nothing concrete to correct the injustice that prolongs the suffering of millions.
It saddens me to see certain names of longtime Lyme players on the rosters of the subcommittees. (Stanley Plotkin; a vaccine subcommittee? You have to be kidding.) Anyone who has been in this game more than a few years but still speaks only of persistence, biofilms and coinfections, or who insists that a vaccine is necessary when it is scientifically impossible, is not in it for the right reasons. What their appointment says to the victims hoping, begging, praying for change, is that different perspectives are not welcome. Egos are more important than truth. Dogma wins over facts. The Tick-Borne Disease Working Group (TBDWG) is a bureaucratic feet-dragging sham, and change is an illusion.
The one FACT that should be the driving force of all activities of the TBDWG is this: OspA is a sepsis-inducing fungal antigen that causes an acquired immune deficiency disease. CDC officers knew it could never be a vaccine, but they falsified the case definition at Dearborn to exclude the immunosuppression cases and get the fake vaccine, LYMErix, to market. They threw us out of the case definition, rigging the testing to detect only the hypersensitivity cases. They threw us out like trash, and for the last 23 years have mocked us and slandered us and subjected us to treatment that meets the United Nations’ definition of Cruel, Inhuman or Degrading Treatment or Punishment—or torture, pure and simple. The CDC perps should be tried in the International Criminal Court, but instead we’re wasting time discussing issues of irrelevance while the bodies pile up.
All of the lives lost, the human suffering, the monetary, physical, and emotional costs since that day in 1994, have all been due to pure greed. And everyone involved in this TBDWG who knows what went down at the Dearborn conference but has refused to discuss it—you know who you are—has a special place waiting in hell, because no amount of back-pedaling or excuse-making can undo the damage that your silence has wrought.
TRUTHCURES met with Dr. Richard Wolitski, the designated federal officer, and Debbie Seem, on October 5, 2017. Our message was:
Science has shown us what the disease is. We explained it in simple terms, despite Dr. Wolitski’s persistent objections to knowing scientific fact. Surely he was aware that it is impossible to un-know the ugly truth.
The TBDWG would end up stacked with purveyors of the “false dichotomy,” or the concept that “chronic Lyme” can only be either persistent spirochetal infection or a post-treatment “syndrome” of unknown, but implied psychiatric etiology. We warned Dr. Wolitski not to let that happen, because that is the only dialogue that has taken place in 40 years, and to continue it would be a death sentence for many.
So, here we are, advice unheeded, crooks and enablers sitting at the table. The few good souls trapped in the middle have a Herculean task ahead of them. My request of them is this:
Please, in all that you do, remember: LYMErix (OspA) caused the exact same disease that was written out of the case definition. OspA alone causes “chronic Lyme,” no spirochetes necessary. So, what is the disease? It’s the aftermath of a septic tick bite. It’s permanent immune wreckage that’s far worse than persistent spirochetes. It is a crime that many of the members of this working group are keenly aware of. It’s a government-created human rights tragedy that the government will continue to conceal at any cost, including by conducting this flaccid effort of a dog-and-pony show.
Don’t be fooled. There is one truth, and it always, always, finds a way to make itself known. Every person involved in this working group has a duty to the truth. Expose it, or be exposed as someone who was complicit in this crime against humanity. History will not be kind. Souls are at stake. Do the right thing.
Sin Hang Lee
Tick-Borne Borreliosis Proficiency Testing is Needed
This Tick-Borne Disease Working Group was established to review HHS efforts regarding tick-borne diseases according to the 21st Century Cures Act, under Subtitle F -Facilitating Collaborative Research- of the Act.
Under Subtitle B--Advancing Precision Medicine of the Act, (Sec. 2011) HHS is encouraged to carry out a Precision Medicine Initiative to address disease prevention, diagnosis, and treatment.
As stated in the public and stakeholder comments, as well as by members of the Working Group on December 11 and 12, 2017 during the public meeting of the Tick-Borne Disease Working Group, there is an urgent need for reliable direct detection tests for the causative agents of tick-borne borreliosis, independent of antibody responses.
About 10 years ago, Dr. John N. Aucott, the Chair of this Working Group, and his colleagues also stated in a published research paper that “Until more effective antigen detection, PCR or culture become available, diagnosis of non-specific, viral-like illnesses in Lyme endemic areas will remain problematic.” , indicating that there was already an urgent need of a reliable test for the differential and accurate diagnosis of early Lyme borrelia infections at that time.
I recently participated in an assessment for the detection of Borrelia burgdorferi in whole human blood samples, a pilot program organized by the State of New York, Department of Health, Wadsworth Center. After the assessment tests were completed and the results reported to the NYS DOH, I received from Ronald J. Limberger, Ph.D. Director, Division of Infectious Diseases NYS Department of Health, Wadsworth Center, an email message on December 29, 2017, as follows:
"Hi Dr. Lee – Please see the attached summary of the recent Borrelia PCR blind test. The number of cells spiked into the blood is an approximation. Wadsworth also performed the testing in a blinded fashion using our real time PCR assay. Overall the results between the two labs were quite comparable. I hope you find this information useful and we thank you for your patience and for participating in this assessment. Feel free to contact me with any questions. –Ron"
Therefore, it is possible that effective antigen detection, PCR or culture has been developed and available for patient care in the past 10 years.
I hereby recommend that this Working Group partner with the NYS DOH to expand this assessment into a national proficiency test program for the detection of all known species of bacteria which may cause tick borne borreliosis in the United States , including Borrelia burgdorferi sensu lato, Borrelia miyamotoi, Borrelia lonestari, Borrelia hermsii andBorrelia mayonii in human blood samples, in the spirit of Subtitle F-Facilitating Collaborative Research of the Act. The Working Group should invite all diagnostic and research laboratories involved in Lyme disease diagnosis to participate for a competitive proficiency test to select the best diagnostic technologies for patient care. At least, this would be a very inexpensive fact-finding program for the Working Group to gather information for making advisory recommendations. After all, reliable laboratory diagnosis of individual cases is the basis for all other relevant clinical, therapeutic and epidemiologic discussions. If necessary, each of the participating laboratories may pay a fee to help defray the expenses for implementing the proficiency test.
- Aucott J, Morrison C, Munoz B, Rowe PC, Schwarzwalder A, West SK. Diagnostic challenges of early Lyme disease: lessons from a community case series. BMC Infect Dis. 2009 ;9:79.
- Kingry LC, Anacker M, Pritt B, Bjork J, Respicio-Kingry L, Liu G, Sheldon S, Boxrud D, Strain A, Oatman S, Berry J, Sloan L, Mead P, Neitzel D, Kugeler KJ, Petersen JM. Surveillance for and Discovery of Borrelia Species in US Patients Suspected of Tickborne Illness. Clin Infect Dis. 2017 Dec 20. doi: 10.1093/cid/cix1107. [Epub ahead of print]
Thank you for your consideration.
Sin Hang Lee, MD
Milford Molecular Diagnostics Laboratory
2044 Bridgeport Avenue
Milford, CT 06460
Email address: email@example.com
Telephone No. 203 878-1438
To the TBD Working Group,
Thank you for your interest in tick-borne disease and your willingness to take part in this important group. I'd like to bring to the group's attention that Morgellons, aka Unexplained Dermopathy, aka Borrelial Filamentous Dermatitis, is a TBD-associated dermopathy in which patients produce and shed unusual filaments from the skin, in addition to the common symptoms of Lyme disease. Two separate studies have shown that Morgellons patients comprise 6% of the Lyme disease population.
It is unknown why some Lyme patients develop Morgellons. Using direct methods of detection, Borrelia spirochetes have been detected in Morgellons skin lesions by multiple labs including 3 university labs. Additional tick-borne pathogens have been detected in Morgellons lesions but it remains unknown whether they are associated with the etiology. Despite multiple studies and multiple peer reviewed publications showing that Borrelia can be detected and even cultured from Morgellons skin lesions. This patient population remains cruelly victimized by the majority of mainstream medicine. The only treatment being offered is antipsychotics which can cause serious side effects and do nothing to treat the systemic spirochetal infection.
Morgellons is a strongly debated issue and this is why I call upon the group for further investigation. Please review the literature on both sides of the debate. Perhaps a committee should be appointed to consider this complex dermopathy. Below are links to peer reviewed studies strongly supporting Morgellons as an infectious condition that is closely associated with Borrelia spirochetes.
Morgellons patients are suffering greatly and nobody is listening. Suicide rates are high in this patient population as many have given up hope. This patient population has been the subject of social ridicule and cruel rejection. Some Morgellons patients do exhibit psychiatric symptoms which cloud the picture but we contend that in many cases this is part and parcel of longstanding, untreated spirochetal infection.
- December 7, 2016 - Canine Filamentous Dermatitis Associated with Borrelia Infection
- October 17, 2016 - Morgellons disease: a filamentous borrelial dermatitis
- Feb 12, 2015 - Exploring the association between Morgellons disease and Lyme disease: identification of Borrelia burgdorferi in Morgellons disease patients
- January 2013, PubMed - Association of Spirochetal Infection with Morgellons Disease
- January 2013, PubMed - Characterization and evolution of dermal filaments from patients with Morgellons disease
- June 12, 2012, F1000 - Morgellons Study Cited by Faculty of 1000 Study of Emerging Skin Disease Among Top 2% Published
- May 15, 2012, Clinical & Experimental Dermatology Research - Morgellons Disease: A Chemical and Light Microscopic Study
- Nov 4, 2011, PubMed - Filament formation associated with spirochetal infection: a comparative approach to Morgellons disease
Thank you for your attention to this serious health concern as it relates to tick-borne diseases.
Amy Jo Sirianni
Dear Tick Borne Working Group;
First, I want to thank you for the opportunity to share my personal story, and for having enough concern to become involved in a solution. You are tackling a tangled web, and my hope is that collaboration prevails in this process.
I was born on Long Island in 1960, moved outside of Boston in 1968, lived in the Berkshires/Hudon Valley area during the late 70s and early 80s, spent time in Connecticut, then moved to mid-coast Maine in 1989. I've been here ever since. The first engorged tick I remember was about 1982, during a camping trip in the Berkshires. No one at that time had any concerns about ticks, and I of course, tortured the thing until it dropped off. Sometime after that, I remember landing in the emergency room with a high fever, very sick. I was given tetracycline. Unbeknownst to me, the years following would be a slow decline in every area of ability that I possessed.
I became a teacher of young children after college, in the early eighties, and continued in early intervention until I was too sick, and in too much pain, to work, in 2003. I did not know that at the time that I would never be able to return.
I had slowly noticed unusual fatigue setting in rather frequently. The type of fatigue where I had to sleep now, and often did, even if I had to find a spot at work to close my eyes. At the same time, pain in my joints began, and low grade fevers that lasted weeks at a time. This went on for over a decade.
My legs felt like anchors dragging along the bottom of the sea, moving fast was impossible. Nausea became a frequent visitor, as well as sweats and chills, and dropping things. During that time, if anyone or anything pressed against my skin, it gave me shooting pains. If I told you all of my symptoms over all of those years, it would fill my entire allotment of words.
In 2001, I was referred to a Lyme Doctor who sent for a western blot. It did not come back CDC positive, but was positive to several Spirochete antibodies, both IGG and IGM. I was started on a regiment of antibiotics, which I did on and off for a couple of years. I felt better for longer periods of time. However, a few more years went by and I began to be unable to complete my job every day. I had gotten to the point where I had about 3 consecutive good hours, before I would need to stop moving for the rest of the day. I had to take several medical leaves.
In 2011, my family physician sent out my blood to a new lab called Igenex. It came back that I was loaded with Lyme. Finally, after all the years and all the losses, I knew it was indeed Lyme Disease. I wish I could have been happy about it.
In that same year, I started seeing a Lyme Specialist in Washington D.C.. I was fading, and reaching a failure to thrive state. So we traveled all that way for 4 years, until 2015. Dr. J saved my life, and after only about a year of treatment with him, I was 75-80% better and had a new lease on life. It was a game changer.
But symptoms began to rear their ugly head again. That same year, I found a tick embedded in my left shoulder. There was a bullseye, and I was given 28 days of Doxyclycline. I felt better, but I also knew better. Since then I have had a reoccurrence of many symptoms, giving me a 4-6 hour window of time before the crash. The big difference now, in 2018, is that there are many protocols for Lyme, so many in fact, it's confusing, and the waters seem very muddy.
As you go through your work here, I, and many, many others, will be hoping that you can be collaborating agents for change. Change for the better is long overdue in the vector borne infected community. As demonstrated by my age now.
Again, thank you.
Amy Jo Sirianni
I want to thank members of the Working Group in your efforts to compile the latest scientific research regarding the diagnosis, treatment, and occurrence of Lyme and other Tick- Borne Diseases. Thank you, also, for allowing those who suffer from these diseases a friendly forum in which to publically express personal experiences of suffering and shunning at the hands of health insurance companies and medical providers.
My thirty year old daughter’s story is similar to others heard by this working group. Approximately ten years ago, during college, she was seen by a litany of doctors for fatigue, joint pain, and “brain fog.” Early in this time frame, an equivocal ELISA was followed by a positive result for Lyme via IgM Western Blot. However, the results were dismissed as a false positive due to the length of my daughter’s symptoms and accompanying negative IgG. A few months later, the IgM was once again positive, but it was treated as another false positive test. We live near Atlanta and were repeatedly told “Lyme doesn’t exist in Georgia.” As we progressed seeking a diagnosis for her symptoms, it was suggested on a few occasions that her symptoms were all in her head, and that my daughter would benefit from psychiatric counseling.
After over a year, feeling abandoned and ignored by the medical community in Atlanta, our daughter began to experience debilitating joint pain and difficulty moving. So, out of extreme necessity, we sought and fortunately located a physician in a nearby state who was educated and experienced in the diagnosis and treatment of Lyme. (This physician has since relocated rather than endure a lengthy and costly fight to preserve his medical license, as the state licensing board was to commence proceedings against his license.) Western Blots were repeated and testing revealed CDC positive for IgM and more than five IgG bands (some of the five required CDC bands and also others.) Unfortunately, within the positive bands, she did not test positive for the five cited by the CDC, to be labeled CDC positive for a Lyme diagnosis. The out of state physicians considered the testing results as well as the clinical presentation of symptoms to determine that she would benefit from treatment for Lyme. My daughter was placed on a protocol of oral antibiotics and her symptoms abated. Unfortunately, the oral medications were stopped a few months after treatment began because she experienced a bout of vasculitis. Subsequently, the joint pain, fatigue, and “brain fog” retuned. After the vasculitis cleared, we agreed to treatment with IV antibiotics, which lasted six months. Dramatic improvement was seen, but at steep financial cost to the family due to insurance denials.
Currently my daughter is on an oral antibiotic, anti-malarial, and anti-parasitic protocol targeting Lyme and co-infections. The last ten years have seen many changes in my daughter’s symptoms and severity. Along the way she has had her gall bladder removed and suffered cardiac arrhythmia, which has since resolved. Despite grueling treatments for her condition, she successfully graduated from a strenuous engineering degree program and is gainfully employed. She still battles severe fatigue and intermittently receives treatment for Lyme related issues.
Our story is not unique among Lyme patients, but through it, I find myself with many unanswered questions as to diagnosis, treatment, and the basic biology of spirochetes. Due to her illness, I diligently continue to read and research these areas to help her cope with Lyme. As a parent of a child who continues to suffer ten years past diagnosis, I hope the Working Group can bridge the informational gaps I have regarding Lyme. I respectfully submit the following questions:
Distribution and Transmission
- In certain non-endemic geographic areas, why are victims and their families told that Lyme does not “exist”? Many papers report Lyme in various mammal, aviary, and reptilian reservoirs throughout the Southeastern United States.
- Why are sufferers and the public in general, told that only black legged ticks transmit Lyme? Many papers demonstrate Lyme spirochetes in Lone Star ticks and identify other vectors of transmission to humans.
Morphology and Physiology of Spirochetes
- How do “blebs”, antigenic variation, and changes in expression of outer surface proteins interact with the immune system? Is it possible the immune system is severely down regulated to allow viral and other biologic opportunistic infections to thrive?
- Are biofilms impeding antimicrobial treatment? How else do spirochetes hide from the immune system? Which tissues are best suited for immune evasion?
- What method(s) do spirochetes employ to evade or disrupt the Compliment system?
- What are the interactions between spirochetes and Toll Like receptors? Papers demonstrate the down regulation of TLR’s responsible for antigen recognition.
Diagnosis and Testing
- Why do IDSA and CDC still rely, exclusively, on two-tiered testing? If Lyme is relapsing, recurring changes in IgM would be expected. Historically, Lyme was tested for via paired sampling with IgM changes over time.
- What were the criteria for selecting which bands and the number of bands needed for positive Western Blot? What about bands specific for Lyme like the flagella? Isn’t a genetically conserved area enough for aiding diagnosis?
- If the immune system is compromised, is possible for bands not to show?
- Do we currently test for multiple strains of spirochetes, or is the test for only one strain form the Northeastern United States?
- What is on the horizon for better, more precise, testing? What is the outlook for PCR testing and testing to identify tick borne co-infections?
- Is Dearborn valid and was it properly vetted by diverse scientific and medical communities?
- Why do patients receive only two to four weeks of antibiotics no matter what symptoms persist? Many papers report the persistence of spirochetes beyond the prescribed antibiotic regimens.
- Why are physicians taken to task for treatment outside the IDSA and CDC guidelines? How do physicians treat persistent infection without fear of license revocation and financial and professional persecution by medical boards and insurance?
- Are the existing treatment guidelines in accordance with current scientific literature? Why does the Datwyler study remain the gold standard employed by the IDSA for limited treatment recommendations? Should it be subject to renewed scrutiny by the scientific community?
The Working Group was chartered to address gaps in information with regard to Tick- Borne Disease. For too many years, the victims of Lyme and their families have endured the struggles of finding and paying for treatment while dealing with varied sources of information and the battle among medical and government groups who ultimately determine who will receive any care and duration of that care.
For far too long, the IDSA, CDC and other Lyme groups have talked over, around, and against one another while presenting their guidelines for treatment and diagnosis of Tick-Borne Diseases, while victims suffer and disease spreads. My hope, as a parent of a Lyme sufferer, is that the members of the Working Group present a unified call to Congress for a mandatory gathering of all vested interests in a respectful and robust debate of the current germane scientific research surrounding Lyme and Tick- Borne Diseases. As Lyme has emerged as the number one reported vector borne disease in our country, united efforts to provide information about, prevention of and compassionate, effective treatment of victims of TBD deserve no less.
The TBD Working Group is giving hope to current victims and those individuals who will contract Tick- Borne diseases in the future. Your important work will yield life-transforming results: knowledge, discoveries, and adjustments that will improve the outlook for these groups now and in the future. Thank you again for your dedication to bringing light to these diseases which afflict so many individuals and their families.
TO THE WORKING GROUP 2018
I thank you all for listen and helping to bring this devastation Tick-borne related issue together. During all devastating societal experiences, comes writings and statements that explain a human experience through the challenge. I wrote this for the patients and sufferers to hang on their walls as they fight the fight of their life. I call it THE INVITE.
Thank you for the invite, my issues are too many,
By David R Thomas
I am President of PA Lyme Resource Network, a 501c3. PALRN provides outreach, education, support and advocacy services to those affected by Lyme and Tickborne diseases in Pennsylvania. State needs have grown the organization to over 25+ regional support groups state-wide. After physicians started coming to our support groups for help, we launched the first CME Tickborne disease conference in the state, and will have our 5th annual PA Lyme CME Medical Conference.
I represent in these comments the 10,000+ patients we touch every year, and my own family who have suffered the trauma of tick-borne diseases. My family became severely ill after moving to the Philadelphia suburbs (Borrelia, Babesiosis, Bartonellosis, Mycoplasma, Ehrlichiosis, EBV, HHV-6, etc.). Symptoms were severe (autistic symptoms, seizures, cardiac, POTS, CIDP, psychiatric, debilitating pain, cognitive, etc.), and yet, reversed with proper diagnosis, and treatment under the care of a highly experienced physician. Our son still struggles with the damage, relapsing in the last year with POTS, and CIDP triggered by Lyme, Babesiosis and Mycoplasma.
Background - The Pennsylvania Experience
Reported cases of Lyme disease in Pennsylvania have continued to climb:
Within the context of ongoing increases nationwide (from 320,000+ cases in 2014 to nearly 400,000 in 2016), Pennsylvania continues to increase, with no actions in place to mitigate this increase:
- 2013 – 5900 reported new cases, or 59,000 actual
- 2014 – 7457 reported new cases, or 74,570 actual
- 2016 - 11,443 reported new cases, or 114,430 actual
Children and Youth Should be a Major Focus:
Youth under 20 make up about 25-30% of reported cases. 28,000 Pennsylvania children/youth were ill with Lyme in 2016. Of these, approximately 20-40% (9,000), will likely develop persistent symptoms. In children and youth presenting symptoms are often cognitive, behavioral, or neuro-psychiatric showing up as behavior or personality changes, difficulties at school, “acting out” behaviors (e.g. oppositional), new onset ADD/ADHD. These are unlikely to be recognized as potential tickborne disease symptoms. And yet, when they are appropriately diagnosed and treatment, these symptoms can be reversed. Rosalie Greenberg, MD, found that the vast majority of her bipolar pediatric patients had evidence of tickborne diseases, and, when treated for these diseases, reversed or significantly reduced their bipolar symptoms.
Young People Are Dying from these Diseases from Ignorance and Denial
At the time of the PA Act 83 task force recommendations, we were aware of a 2014 death of a 2 year old (York County) from Rocky Mountain Spotted Fever, and a 38 year old (Poconos) from Lyme, Babesia and other coinfections in 2012.
Since 2015, the PA Lyme community has been traumatized by several tragedies – young people destroyed by these diseases, in one case suddenly, and in another after a protracted illness with roots going back to tick bites in elementary school, and in his high school years that were undertreated, with the last episode in college triggering serious, chronic illness. These parents and families deserve the very best public health response we can mount:
- June 2015 – 51 year old, Tommy Valerio, prior triathaloner (Poconos), Lyme, Babesia, Bartonella
- July 2017 – 25 year old, Pete Smith (Quakertown), Lyme disease known, cardiac complications, other coinfections not determined but possible (not tested for coinfections)
- Sept 2017 – 50 year old, Jeff Naticchia (Bucks County), Babesiosis, delayed diagnosis
- Oct 2017 – 29 year old, Kevin Furey (Montgomery County), Lyme, Babesiosis and multiple other tickborne infections
These deaths were preventable, had up-to-date, and knowledgeable medical care been available. The lack of early recognition, diagnostic experience including proper evaluation for coinfections, and appropriate treatment follow-up were all critical factors in these tragedies.
The urgency to act is high. Lives are being destroyed by old dogma and inaction.
In Pennsylvania, Act 83 required the Department of Health to act, and yet it took them 2 years to request the funding needed. We are told that state Health departments are ham-strung by their dependency on CDC funds for their budgets. They imply that they must stay aligned with CDC Lyme disease dogma or risk their funding.
State’s Inaction Reflects Federal Position: this trickles down from the current Federal approach to Lyme and Tickborne diseases which is to deny and undermine it’s seriousness. While Lyme disease is 6x more prevalent than AIDs, 2.5x more prevalent than Breast Cancer, there is only $28 million spent on Lyme R&D compared to the multi-billions being spent on HIV ($3.5 billion), and $46 million on West Nile Virus. WNV has reported only 60 total cases since 2000 (https://report.nih.gov/categorical_spending.aspx). The CDC continues to downplay the seriousness of this disease promoting only the IDSA guidelines for HCPs shutting down options for patients with persistent symptoms. This intentional denial of options is causing much harm, and ignores the significant shift in evidence supporting persistence, and the complexity of these diseases.
The lack of CDC reporting on current cases in 2017 (MMWR reports dropped Lyme disease) As of January 2017, the Centers for Disease Control stopped public reporting of Lyme disease cases, even though Lyme disease is a nationally reportable disease. The CDC is required to report in a timely manner such disease cases to properly inform the public, health agencies, practitioners, and institutions. Surveillance and tracking of Lyme is absolutely critical to informing the public health response.
Hidden Costs of Disability – Human and Financial: Beyond the significant personal impacts these diseases may cause, TBDs also create significant economic burden in the United States. Over $1 billion in annual medical expenses in the United States have been attributed to Lyme disease as well as up to $10,000 per patient annually in lost productivity. Applying the above cost estimate to Pennsylvania’s 11,443 confirmed 2016 Lyme disease cases, the annual estimated cost in lost productivity alone may likely exceed $1 billion. In addition, our Department of Conservation and Natural Resources has publicly stated that the vast majority of their disability cases are due to Tick-borne diseases, and yet this is not always made explicit.
Recommendations – Immediate, Short-term Actions Required
I decided to focus on short-term, low-cost actions that could provide immediate benefit for patients. The working group is already well-informed about major gaps, requiring longer-term, complex solutions including the gap in well-studied prevention strategies, gold-standard diagnostics, broad-spectrum education of health care practitioners, broader treatment studies, and multi-disciplinary efforts and oversight such as that employed in the “Manhattan Project” to address the HIV/AID epidemic of the 1980s.
1. Correct Public Health Information (CDC) Inaccuracies and Send a Strong Message of Urgency
- Re-start CDC Lyme Reporting and publish 2017 data: reporting must restart immediately. Lack of data reduces concern. Lyme is the ONLY disease the CDC stopped reporting in 2017.
- Update CDC information to represent divergent perspectives per IOM recommendations for rapidly emerging diseases. They should “represent a broad spectrum of views identifying where they diverge, including alternative expert interpretations of evidence, recommended options with explicit reference to their assumptions, values and intentions to inform HCPs and patients effectively”.
- Name this an Epidemic: This is a public health crisis. The World Health Organization (WHO) has said it. Other countries experiencing a much lower burden of disease are saying it. And now the United States must say it is so
2. HCP Targeted Communications:
- Launch HCP communications that recognize this epidemic and shifts perception from old dogma, recognizing ambiguities of the science and breadth of perspectives, and which increases the sense of urgency to catch cases earlier and that explicitly generates awareness of options available for persistent symptoms.
- Highten Awareness of Neuro-cognitive and Psychiatric manifestations to save lives: multiple studies have reported the neuropsychiatric manifestations of Lyme disease on patients. The major cause of death in Lyme disease has been reported to be suicide. Recent studies predicted suicide rates resulting from Lyme and associated diseases. Using this model approximately 410 suicides in Pennsylvania per year could be attributed to Lyme and associated diseases. These complex diseases, if not diagnosed and treated early and properly, can affect the central nervous system and lead to many distressing symptoms significantly affecting quality of life, and functioning. Links continue to be established in the research between tickborne diseases of “unknown” causation – including pediatric cognitive/learning disabilities and psychiatric presentations (study found more than 75% of bipolar patients were infected with tickborne diseases; when treated bipolar symptoms were reversed or greatly reduced, Rosalie Greenberg, MD).
- Standard Brochures for Physician Distribution: immediate alerts and information about increased cases, coinfections – specifically Babesiosis, testing issues, and availability of multiple treatment approaches/guidelines for use in cases when symptoms persist.
- Implement patient notifications regarding inaccuracies of current testing – e.g. a negative test from the standard 2-step protocol does not rule out Lyme disease. The Virginia recommendation stated: “develop and implement a standard brochure that physicians ideally should provide to patients when they are evaluated, either by clinical exam or lab testing, for potential Lyme and related tick-borne infections… regarding the effectiveness of testing… “.
- Regular, More Expansive Alerts: the CDC reported findings regarding several young adult Sudden Cardiac Death cases that were found to be due to cardiac infection with Lyme disease. With PA’s recent young adult deaths due to cardiac involvement, this must be communicated regularly. Sending a 25 year old home after removing a pace-maker with no follow-up or treatment, when he had ongoing symptoms, must stop.
3. School-children Population Focus These recommendations were in PA Act 83 and are low-cost.
- Notifications to parents regarding risks and protective measures, especially in outdoor activities
- Encourage school staff to remind students and parents of “tick-checks” after outdoor school events
- Implement standard protocol within schools for appropriate tick removal & parental notification
4. Insurance Company Alerts: Insurance Companies continue to deny treatment prescribed by licensed physicians on the basis of outdated medical guidelines. This is directly contributing to the burden of disease in this country. Insurance companies should be put on notice that multiple schools of thought and guidelines are available in the care of tick-borne diseases and that when licensed practitioners elect such options for their patients, they are exercising their medical judgement appropriately.
5. National Plan Needed: In 2016 France became the first country to release a national plan to address tick-borne diseases. The plan includes ramped-up surveillance of ticks and infections, prevention actions – lots of them, better diagnostics and better treatment. What is unique about the plan is the QUANTITY, NATIONAL COORDINATION, HIGH-LEVEL ATTENTION, AND BUDGET attacking the problem as a national health crisis. “If we do a good job at prevention, we’ll have fewer patients end up… struggling in the medical system,” said Lucie Chouin, a public health official for Greater Eastern region of France. “For me, prevention is part of a package; if we only do so much, and don’t do anything upstream, the problem won’t be resolved.” The US has ten (10+) times the cases of these countries, but has no federal plan in place.
The combination of the disease itself, the current “gas-lighting” of patients which ranges from ignorance to denial, to outright disparagement and belittlement (“the aches and pains of daily living”), and the toll all of this takes on family systems, relationships, and the ability to work, conspires to leave patients hopeless, and full of despair. In our support groups, we have encountered too many devastating cases, with homes lost, marriages destroyed, children’s futures compromised, individuals going bankrupt and even becoming homeless. It is frankly hard to believe what is happening in the trenches, and the ongoing denial of so much human suffering. Short-term actions can send a strong message that the “status-quo” is no longer acceptable.
Thanks to all of the members of the Working Group for your efforts in making forward progress against the Tick-borne disease epidemic in America.
Julia Wagner, MBA, PhD (student/in process)
President, PA Lyme Resource Network, a 501c3
Appointee to PA Task Force on Lyme Disease and Related Tick-Borne Diseases Pursuant to Act 83