/www.facebook.com/drrichardhorowitz/posts/1569992886422837Meeting Two of the Tick-Borne Disease Working Group was an enormous success, and exceeded my expectations (the length of this post will also probably exceed your expectations!)
John Aucott opened the meeting with an overview of our task, and the need to identify gaps in diagnostics and therapeutics. Kristen Honey again discussed hitting a new reset, since we can’t go back and change the past, but can move forward. The common denominator was that we need to put patients first and achieve better outcomes, while doing a better job of listening and valuing all perspectives. One of the mottoes that emerged was “better health through better partnerships”.
The meeting then opened with organizational perspectives from healthcare providers. Dr. Sam Shor first provided the ILADS perspective. ILADS goals were improving prevention, detection, and outcomes. He identified three barriers to achieving that goal, that needed to be changed at the level of the CDC. The first was changing their dogmatic guidelines, the second was changing the two-tiered system for diagnostics, and the third was the need to change the concept of chronic Lyme disease. How could this be accomplished? Sam discussed the difference between a dogma which is a fixed belief without question, versus the need for guidelines to simply advise people. He then went through the problems with the two-tiered testing system which has roughly a 50% sensitivity, yet was still considered by some to be dogma. He reminded people that the Virginia governor’s task force stated that no test can absolutely rule out Lyme disease, and that it is first and foremost a clinical diagnosis.
Sam then went on to discuss chronic Lyme disease as a multisystemic illness with an ongoing infection by Borrelia burgdorferi sensu latu complex, and that the IDSA guidelines purports that chronic Lyme disease does not exist. He then showed both animal and human literature which supported persistent infection, including articles by Stricker, Hodzic and Embers, and differentiated between PTLDS (post-treatment Lyme disease syndrome) and late, undiagnosed Lyme disease, where short-term antibiotics have failed up to 71% of patients with chronic and late stage manifestations.
Sam then went on to describe our increased tick exposure risk in the United States, and that the hallmark of Lyme disease, the EM rash, is frequently absent or misidentified (Bacon, Klempner, Kuegler). Delays in diagnosis can result in chronic fatigue, joint pain, headaches and a myriad of symptoms as Lyme is the “new great imitator”, often confounded with other diseases like Chronic Fatigue Syndrome and Multiple Sclerosis. He went on to show that two out of the four NIH studies showed a positive clinical benefit, and four non-NIH trials showed benefit, yet the IDSA dogma restricted longer-term treatment. He also outlined that coinfections like Babesia are known to increase the severity and duration of illness (Krause), and that these are also not adequately accounted for in the IDSA guidelines.
His conclusion was that there is no place for dogma, as we still have too many unanswered questions. He asked the working group to have an open, balanced interpretation of the literature, to help increase education to clinicians, the public, and government agencies, while working on goals to improve prevention, education, diagnostics, and effective treatment.
Betty Maloney gave the next stakeholder perspective. She represented the Partnership for Tick-borne Diseases Education. Betty discussed gaps in our knowledge base, which also included prevention, pathogenesis, diagnosis and treatment. She asked important questions such as how can we decrease the tick population size and range and improve post-exposure prophylaxis? She reminded everyone that the literature has not proven that a single dose of doxycycline or topical azithromycin is effective as post-exposure prophylaxis, and that we may need to look at herbal preparations and/or multi-drug antibiotic regimens in future studies. She also discussed species and strain variations and how host pathogen interactions may explain why some people do not become ill. Is that the reason we see a wide spectrum of manifestations? What allows for disease latency? What triggers reactivation? Are morphological variance and “persisters” clinically relevant? She showed ample evidence that Borrelia burgdorferi does persist and that we need to turn our attention to how survival mechanisms might be overcome. Can the immune response be uncoupled from the pathogen? If so, how can it be stopped or prevented?
Regarding diagnosis and treatment, Betty highlighted the fact that we need direct detection tests and not just serology to evaluate these patients, and that most ILADS treating physicians have seen single drug regimens fail sick patients, whereas many respond to combination therapy (that has clearly been my experience, based on the biology of the organism and its ability to hide in the intracellular compartment along with other intracellular co-infections). She asked us to look beyond randomized controlled clinical trials, as well as to look beyond past studies which were too small with design flaws and/or poorly analyzed. Treatment responses are heterogeneous and trials only report averages. “Misapplying averages can cause harm, by giving treatments which do not help, or denying patients treatments that would help” (Kravitz 2004). She felt that the CDC and NIH had biases which distorted the evidence, especially regarding the utility of the two-tiered testing schema and persistence. Why for example did Dr. Adriana Marques from the NIH in her xenodiagnostics study discredit her own findings in a symptomatic patient who was PCR positive more than 400 days posttreatment?
There also have been no treatment trials evaluating patients who are multiply infected. A prior study showed that doxycycline was effective against Borrelia 47% of the time, but dropped to 20% once Borrelia burgdorferi and Anaplasma were present. She therefore urged us to focus on understanding the pathogenesis of tick-borne diseases and our immune response, to get reliable testing, and to develop safe, effective durable vaccines. She also called for the CDC, NIH and IDSA to clean up their websites as there is enough available evidence to change the current recommendations.
Paul Auwaeter was the third stakeholder perspective, representing the Infectious Disease Society of America (IDSA). Paul also asked us to improve the prevention, diagnoses and treatments for Lyme disease. He reminded us of the IDSA commitments to evidence-based recommendations, regarding surveillance, prevention and diagnostics. He asked for increased funding for the CDC, increased surveillance in high-risk and neighboring states, and increased surveillance for tickborne co-infections. Regarding prevention, he said that we need to learn from past challenges with the Lyme disease vaccine. He felt that there were unsubstantiated claims made against the manufacturers of the LYMErix vaccine (huh?), and that the new vaccine needs to cover multiple species with multiyear protection, that is at least 80% effective with no serious adverse reactions. He reminded us that vaccine development can be costly but that long-term cost savings and public health improvements would be worth it. He suggested possible incentives for vaccine manufacturers, and that it was not likely to have a standardized vaccine recommendation for all 50 states.
Regarding diagnosis and treatment, he felt that accurate diagnoses best informs treatment, which will only happen with well-studied tests, especially those serological tests that are FDA approved. He acknowledged that there are inherent limitations of antibody testing in early Lyme disease, but felt that serology performs well over time as the immune system responds (there are multiple studies by authors including [but not limited to] Ang, Mangaroni, Cook and Puri, Stricker, Schutzer, Brunner, Kaiser, and from the IDSA, Steere and Dattwyler which prove the contrary). Since the NIH and CDC have a serum repository which was set up in 2011 with well-characterized Lyme disease patient histories and related serum samples, he felt those could be used to help with creating direct detection tests. This would help decrease false negatives as well as false positives. He stated that PCR does not rise to the challenge and that the organism is not easily cultured, so that we need to do tests that correlate with a microbial cure. Since some of these newer tests also have a long lead time with clinical validation, he also encouraged us to increase incentives, while again advising against over testing, over diagnosis, and overtreatment.
Regarding treatment, he felt that there is no evidence that longer treatment in early Lyme disease is of any benefit, and that persisting symptoms beyond the initial treatment are not due to active infection. Why? Randomized clinical trials have not found benefit. Since there was a 30% positive response in the placebo group, he asked the question: Are we doing better than placebo? Since the CDC recently published a paper illustrating five cases with serious bacterial infections in patients treated with longer-term antibiotics for Lyme disease, including complications of C difficile and death, he felt that PTLDS served as a model (like Epstein-Barr virus/mononucleosis) as to why fatigue, pain and sleep disorders do not improve (the 16-point MSIDS model described in both of my books “Why Can’t I Get Better? and “How Can I Get Better”, with over 800 scientific peer-reviewed references, explains why the majority of patients that I see with chronic Lyme/PTLDS stay ill. The 3 I’s, infections, immune dysfunction and inflammation [from multiple sources] is at the root of the problem). He said that the IDSA stands by high-quality evidence when they made their recommendations.
I did not want to go through the Marzec paper by the CDC with him, but for those interested in seeing responses to the paper, ILADS President Sam Shor wrote a letter to the editor of Morbidity and Mortality Weekly Report (MMWR) in response to the article by Marzec et al. titled Serious Bacterial Infections Acquired During Treatment of Patients Given A Diagnosis of Chronic Lyme - United States, and challenged the 3 conclusions: 1. Characterization of chronic Lyme disease as an invalid nebulous condition 2 “…..evidence that the recommended two-tiered serologic testing is actually more sensitive the longer B. burgdorferi infection has been present” 3. “Studies have not shown that such treatments lead to substantial long-term improvements for patients.” Sam has multiple scientific peer-reviewed articles in his letter refuting these claims. Dr S.H. Lee also submitted a response (June 18, 2017) stating that the authors have not presented evidence to show that chronic Lyme disease patients with borrelial spirochetemia proven by culture or by gene sequencing do not benefit from additional antibiotic treatment. In medicine, certain chronic infections, such as subacute bacterial endocarditis, may require intravenous or prolonged antibiotic treatment in spite of its potential side effects (Hoen B. Epidemiology and antibiotic treatment of infective endocarditis: an update. Heart 2006 ;92 :1694-700. Review).
Although I did not agree with Paul on some of his points, I was happy to finally meet him and was I was glad he was there to present the IDSA perspective at a meeting where the ILADS perspective was also given. As we are now building bridges, I went over to him and introduced myself. I gave him my card and we chatted for a few minutes, as I extended my appreciation for his coming and presenting diverse viewpoints.
The fourth stakeholder was Elquemendo Oscar Alleyne, DrPH, MPH, from the National Association of County and City Health Officials (NACCHO, not nacho’s!). He represented 3000 local health departments from across the United States, and let us know that although they are on the front lines of public health, there is no integration with federal and local agencies. He has been the director of epidemiology in Rockland County, New York, and NACCHO must track hundreds of thousands of cases per year of multiple tick-borne infections including ehrlichiosis, babesiosis, Powassan and Lyme disease. They need to track and report the information and communicate with families, and the role of these public health services include bio surveillance of over 70 diseases. For effective surveillance they need electronic reporting which allows them to increase response time to illnesses in the community and empower community members. He has personally seen the change from endemic to emerging threats of tickborne illnesses, as they increase with a fervor. He asked the question of the group: how do we translate the information into practice, and then integrate this information into effective practice? In other words, we need “practice-based evidence” not just “evidence based practice”. He sees the impact of a lack of vector control at the local level and the need to overhaul and change the process. How well can we integrate this information into a true partnership? How can we be part of the bridge to increase effective diagnostics, education and treatment? He was clearly concerned about the burden that local health departments face in controlling these emergent threats and wants to bring didactics to life!
The fifth stakeholder perspective was Katherine M Brown, Council of State and Territorial Epidemiologists (CSTE). She works for the Massachusetts Department of Health and talked about tick-borne disease challenges to public health. She spent the majority of her career in Massachusetts and has seen the state heavily impacted. She spent countless hours speaking to patients who are deathly afraid to go outside, while providers are frustrated with inadequate diagnostics. She has also had personal experience with tickborne diseases, as she herself has been impacted, as well as her family and friends.
She supports public health surveillance and effective use of epidemiological data to guide public health practice. CSTE monitors health status and burden, diagnoses and investigates potential health hazards, and inform, educates, and empowers people about health issues. All the information is confidential, and they may only collect data that is necessary for public health functioning. They follow Lyme, Anaplasma, Babesia, Powassan in other tickborne diseases for surveillance, but not diagnostics. She highlighted the fact that endemic states have massive burdens and that there is a clear difference between a clinical case definition and standardized case definition. Due to that, and the burden of surveillance, she feels that the data is incomplete (I wholeheartedly agree!). She emphasized data driven prevention and educating healthcare providers about the changes in distribution of disease and emerging tick-borne threats, as well as educating the public about the importance of tick bite prevention.
What is needed? Better diagnostics, especially where it’s based on antibody detection versus pathogen detection. She also suggested increasing the availability of lab testing for emerging diseases like Powassan, supporting public health infrastructure with less focus on disease specific resources, using EHR and real-time disease reporting, in taking basic research and converting it into methods for effective vector control. Katherine felt that this should be done at a community level, and not just rely on personal protection, although she felt that assistance with an outreach program to achieve widespread behavioral changes around personal protection could be helpful.
The sixth stakeholder was Sarah Vetter, Association of public health laboratories (APHL), in Minnesota. They monitor, detect and respond to health threats. Sarah felt that it was essential to have a comprehensive detection system and new diagnostic approaches. The present surveillance system is limited by the number of states receiving funding, even though the range of ticks and their diseases are expanding, such as the Bourbon and Heartland viruses, emerging Rickettsia, and Borrelia miyamotoi. She also explained that we need updated diagnostics for Lyme disease, where we define and institute a comprehensive and adaptable tick-borne disease surveillance system, while examining tick vector prevalence. To achieve this end, she encouraged the development of new diagnostic tools to increase the accuracy of tickborne disease identification, such as using technology that identifies multiple tickborne pathogens at once, i.e multiplex assays, while then doing enhanced active surveillance. This is especially important as novel emerging pathogens appear.
Sarah also felt that we need to foster an open dialogue between the FDA and diagnostic laboratories to fill in the gaps. She suggested using recombinant proteins to increase specificity, which are better than whole cell lysates, with standardized reagents across all labs. Although PCR may be the most sensitive for early detection, she questioned whether serology would still be appropriate for later samples. Then establish national training programs for tick-borne testing and encourage widespread access to these laboratory tools. Finally, she asked us to rapidly update the guidelines as new laboratory testing is available, and then to improve clinicians training on the best way to use the testing.
The final testimony for the morning session were public comments. Kristen reiterated that she appreciated the openness, respect and gratitude that people are sharing their experiences.
The first public stakeholder was Joe, who discussed constitutional rights. He had written in about the Dearborn conference, and its unintended consequence was that he can’t find a doctor to treat him. He pleaded with the panel that all he was trying to do was survive until tomorrow, as many of his neighbors have died. He asked that we give everyone attention.
Jenna Luche Thayer was next. She worked in the past for US governmental organizations and the WHO, working on behalf of human rights, transparency and accountability of governments. She has participated on federal boards, and looked for ways to increase representation and accountability. She was the founder of the Ad Hoc Committee for Health Equity in ICD11 Borreliosis Codes, dedicated to improving the coding for those suffering with Lyme and associated diseases (many manifestations of Lyme and tick-borne disorders are not listed in the present ICD coding system, which ultimately result in denying patients appropriate care by insurers, which is a human rights issue). She had two main complaints. First, she complained of the use of federal funds, such as $32 million in NIH grants going to smear campaigns against doctors who do not treat according to IDSA guidelines. Secondly, since she has participated on federal boards, she was concerned that those of us on the Federal Tickborne Working Group were being designated as special government employees (SGE’s), as opposed to representatives. Representatives share the points of view of nongovernmental organizations which recognize groups such as doctors, patients, and advocates, and are free to speak. SGE’s on the other hand, promote government interests first and are under HHS supervision with limitations, even days not serving on the working group. There are also legal, financial, representative, and research limitations. As a human rights defender, she was concerned that as SGE’s, we can’t testify against government employees, speak up against outdated CDC guidelines, generate earnings from research or speak freely at medical events. She felt that the present system has ignored fatal medical conditions (i.e. tickborne diseases) and asked the members to be converted to a representative status. After her talk, Richard Wolitski explained that our constitutional First Amendment right to free speech is not being denied.
Rachel was the next public stakeholder. She explained that she felt violated by multiple individuals, especially the righteous keepers of the IDSA Lyme guidelines. She felt there were abuses of power which deflected guilt and blamed victims, and that these guidelines ridiculed patients who were written off because of “conversion syndromes”. She also took to task Christina Nelson at the CDC, who was constantly discrediting scientific evidence, and stated “Lyme practitioners are quacks, off the track, with treacherous protocols”. She couldn’t understand why the medical system allow dermatologists to treat with long-term antibiotics for acne, or allowed infectious disease doctors to treat long-term for tuberculosis. Similarly, primary care physicians were allowed to give longer-term antibiotics for common infections (i.e., chronic urinary tract infections), yet if a Lyme doctor does it, it’s life-threatening. On the other hand, if doctors offered her toxic drug cocktails, such as those used to treat cancer, that was allowed, and maybe would make her better.
She explained that at one point in her life, death looked better than her life. She did antibiotics for three years, and (as opposed to the recent CDC article by Marzec), under her Lyme doctor’s care, she did not develop Clostridium difficile, and is now so much better. “My Lyme doctor didn’t kill me, but helped me. He saved me while local MDs allowed me to get sicker”. She explained that other doctors would diagnose such people with psychiatric disorders, and that are present medical system is flawed, harming patients. She asked us to listen carefully to the stories of misdiagnosis and mistreatment of patients who were suffering. She also asked us to call off the medical boards (who were investigating doctors and removing their licenses across the United States if they do not follow IDSA guidelines), and heal the sick. The culture of cover-up is now being revealed, and asked us “which side will you be on?”
Enid, who is a PhD clinical psychologist helping at the Dean center was the next speaker. She lived her last 11 years on Martha’s Vineyard and only recently received support. Local MDs, walk-in clinics, and hospital MDs were of no help to her. She never tested positive by two-tiered Lyme testing through local laboratories, but when she used IgeneX laboratories, she had a positive diagnosis. Once the diagnosis was made, she felt hampered to get treatment, as her problem was compounded by the actions of insurance companies. She explained that insurers threaten the license of doctors who fear repercussions, and that mainstream doctors won’t treat out of fear, which is increasing the number of cases in the United States. There are also thousands of Lyme support groups across the country who find that they are sick because of increasing numbers of coinfections (that has been my experience), and many believe there were infected or worsened by the prior Lyme vaccine.
She explained that many people suffer in denial and that they are given opiates and painkillers instead of treating the source of their illness. She explained that her only hope was to find a Lyme literate doctor, like Dr. Richard Horowitz, who saved her life and the life of her family. She also explained however that most cannot afford to go outside the insurance model, as most Lyme literate doctors are out of pocket (I did work within the insurance model for years. The problem arose once I was the first doctor to diagnose babesiosis in Dutchess County New York, which was not previously known to be endemic for this parasitic disease. I diagnosed Babesia in a young woman, who was paralyzed for five years in a wheelchair from Lyme disease, and once the Babesia was treated, she was finally able to walk out of her wheelchair. She is still ambulating to this day. I then subsequently diagnosed hundreds of cases, but insurance companies [I will not mention their names] complained of my treating a disease that did not exist in our area, costing them too much money, thereby excluding me from their insurance panels). Martha’s Vineyard is Ground Zero for these type of tickborne infections and is a financial and economic disaster for patients. She encouraged insurance companies to improve their guidelines and share in the knowledge and experience of Lyme literate doctors.
Susan Green was the next speaker. She has been a practicing attorney for years as well as a Lyme patient. Her first experience with the illness arose with a seizure which impaired her ability to speak. Her memory was also wiped out. She went from doctor to doctor and no one knew what was wrong. John’s Hopkins University gave her a test and her test was highly positive, although prior tests were negative. Her doctor leaned across the desk and said to her “I can’t treat you. I would be drummed out of my society”. She therefore was forced to go from doctor to doctor looking for answers, and ended up doing longer-term antibiotics for 20 months with hyperbaric oxygen therapy which helped her return her ability to function and speak.
She explained that doctors who treat Lyme disease with longer term antibiotics risk their license. They come under attack by medical boards. As per Rachel’s comments, she also explained that it was acceptable to treat acne with one year of antibiotics, but a potentially fatal disease cannot be treated for more than 28 days. She has seen medical boards engage in discriminatory practices against doctors who treat long-term, and go into their charts looking for coding and record violations to sanction them. She asked our working group to please unfettered the hands of those doctors were trying to help sick and marginalized patients.
The next patient was Linda. She expressed her delight in seeing this collaboration. She lives in New Jersey and her story is similar to others. She was misdiagnosed for two decades or longer because of the recommendations of two-tiered Lyme testing. At 10 years old in 1974, she remembers removing an embedded tick and then had subsequent exposure while in her early 20s, she was hiking and rock climbing in Vermont and then in the New England area. She subsequently developed cardiac symptoms and became depressed, being diagnosed with bipolar disorder. She had a horrific experience with doctors and specialists. She was primarily diagnosed with a mental health disorder due to her undiagnosed tickborne illness which caused her medical decline. Although her childhood was difficult, she accepted her diagnosis, and despite her challenges, was not suicidal in the initial stages. However, over time, as her tick-borne illness was undiagnosed and untreated, she became suicidal and then infected her unborn child. She asked us to think about what would be like if your wives and children were so depressed from an illness that they could commit suicide. She finally found a Lyme literate doctor who diagnosed her with tickborne illness including Babesia WA-1, Brucella, Mercury, lead, and renal failure with liver and kidney failure. Extensive antibiotics brought her back to life but is not cured.
Jennifer was the next patient who again talked about suicide after feeling so badly from her illness. Her symptoms started in 2013 after a root canal. For one and ½ years she went from doctor to doctor, including multiple specialists and was even told that one point that she might have cancer. When she finally discovered her illness, the CDC called her and asked her if she lived in endemic area. At one point she was in an emergency room looking for help, and they said that they don’t diagnose or treat Lyme and that she needed to see an infectious disease doctor, who had a three month wait. She essentially was left to die, as many of the physicians she saw said that they don’t treat Lyme, show she explored the holistic medical route, which finally helped. She encouraged us to look into integrative treatments for Lyme (I spoke to Scott about this, who is on the panel, and express the need for the office of alternative medicine at the NIH to look into alternative treatments instead of antibiotics, and scientifically validate some of the treatment regimens that people are presently using). She finished her testimony and asking “How can you make a vaccine when you don’t know what to test for, since the two-tiered testing is inaccurate?”.
The next testimony and patient stakeholder perspective came from Jennifer,
from the Johns Hopkins University School of Public Health. She was ill for the last 7 to 8 years with multiple symptoms including neck pain and sweats, seizures, difficulty seeing, with periods where she couldn’t walk. No one could figure out what was wrong with her. Her symptoms would wax and wane and come and go. She expressed frustration in finding a doctor to help her, and finally found a courageous doctor who persisted, and helped her. She credits ILADS physicians, and feels that many patients are still alive and breathing thanks to their protocols. Her doctor at John Hopkins told her that they didn’t believe in chronic Lyme. She clearly expressed the need for education since there are hundreds of publications which represent the ILADS point of view. She also asked us to improve diagnostics and help identify where these pathogens exist, using newer technologies such as metabolomics and nanoparticles. She finished her testimony encouraging us to work collaboratively and improve the education of physicians.
Christine with the next patient stakeholder perspective who told the panel that she was born with tickborne illness. She cried throughout her testimony. She told us that her insurance company would not pay for her treatment, and feels lucky to be alive because so many do not make it.
(Several patients who testified discussed suicidal ideation. Robert C. Bransfield, MD, a psychiatrist with an extensive experience treating Lyme disease, published a recent article on the relationship of Lyme and suicide: Bransfield RC. Suicide and Lyme and Associated Diseases. Neuropsychiatric Diseases and Treatment. 16 June 2017 Volume 2017:13, Pages 1575-1587. This new study according to Dr Bransfield, “may open the door for greater collaboration between psychiatrists, psychoimmunologists, evolutionary biologists and infectious disease physicians to help prevent a significant number of deaths from suicide. Currently there are over forty thousand well documented and many more undocumented suicides in the United States each year and many are unexplained. A number of other infectious diseases have previously been associated with suicide. Many who work with Lyme disease patients have noticed suicide is a major cause of death in these patients. This recently published article analyzes the association between suicide and Lyme and associated diseases. Based upon a chart review and a literature review including the psychoimmunology, neurochemistry and neural circuitry of suicide and epidemiological calculations it was demonstrated “There is a causal relationship between Lyme and associated diseases and suicide, the pathophysiology can be explained, and it causes a significant number of suicides.”).
Christine let us know that the current situation is not working and doing nothing is no longer a viable option. She asked us to get greed, ego and politics out of the way so that this epidemic can be solved. She reminded us that we have lost many along the way because the pain of living was too much for them to bear. There were many in the audience including myself, who became teary-eyed listening to her testimony.
Bob Savatino was the next speaker, and was here as a patient and advocate. He is director and founder of Lyme Society, INC. He felt that we had a unique opportunity here, and asked us to hit the reset button and create change. This was essential for those patients were suffering. He indicated that he starts and ends his days not as a father or provider, but as a patient. He lost his knees and shoulders and is a device in his chest due to this illness. He also suffered Bell’s palsy. He applauded all of us for being on the working group and thanked us for fighting the good fight.
As we finished up with the morning speakers, Kristen asked us to reflect on the powerful stories that we heard this morning, and thanked everyone for sharing. She highlighted that the mental health aspect of this illness with stories of people either contemplating suicide, or doing it, should inform us as a group and allow us to reflect on the importance of what we are working on. John also let us know that these public comments were important. He let everyone know that we are listening, and thanked people for their courage and willingness to share, and that we will incorporate the comments we heard this morning into the testimony for the working group.
The morning session finished with the roles and responsibilities of the working group and voting procedures. Rich Wolitski reviewed and discussed the charter, including the roles and responsibility of being a special government employee (SGE). He reiterated that we brought on members for their independent opinions and that we are not functioning as an employee of the government. We are here to give expert opinions, challenge opinions, and that we are here to fully participate with the full weight of our experience. We are not being asked to conform to any existing policy and procedure. Within the group, the general sense he had is that it will incorporate differences of opinions and he assured people that SGE status will not affect the functioning of the working group.
He then went on to discuss the roles of the chair and vice chair, meeting agendas, convening again, how we conduct meetings and approve minutes, and laid out a plan that the work of the committee will be accomplishing. He reminded us that we need to stay on track and that we need to be aligned with our charter and FACA (federal advisory committee act) regulations. FACA groups cannot meet without a designated federal officer (DFO) or an alternative DFO being present. He again stated that there will be openness and transparency and that we are nonpaid members. We will be giving independent advice on different subject matters with our expertise, with the ability to participate and vote in meetings and contribute to work being done on subcommittees. Each of us will be serving on at least one subcommittee and possibly two. We will need to be approving the draft reports and the president and vice chair will be visiting the subcommittees. We will be maintaining records and ensuring efficient operations and public comments will be logged in, so that we understand what people are saying, and what the issues are that concern the public.
To efficiently stay on track, we have a contract with Communicate Health, an organization that will provide meeting notes, writing and committee support (I probably could’ve used them with the longest post of my Facebook career!). The roles will include assisting with planning, staffing meetings, taking notes, and providing draft summaries. They will also coordinate and attend all subcommittee meetings and help to draft meeting agendas and the congressional report with our summary recommendations.
Rich then went on to discuss our charter. Its purpose was established within the 21st Century Cures Act in 2016. We are to provide expertise and review all efforts within HHS related to tick-borne diseases, insure inter-agency coordination to decrease overlap, and examine research priorities. He again reiterated that there will be transparency and openness and that the meetings are open to the public and will be listed on the Federal Register 15 days in advance. Public comment can be submitted. Our recommendations will also be “objective and accessible to the public” and there will be no secret set of documents. All the slides will be made available, and after a closed administrative or subcommittee meetings, there must be documents and information about them which will be provided by the Government in the Sunshine Act, 5 USC 552b ©. This will include a list of all attendees, the agenda, presentations and other materials presented to the subcommittee. By December 2018, we must submit a report that summarizes: ongoing tickborne research across a full range of issues, advances, Federal activities, gaps and tickborne disease research, working group meetings, and comments submitted to the working group.
Rich let us know that there may be a follow-up where individuals can be named in these comments, and let us know that we can find everything on the HHS website with the foundation for the working group, charter, work we do, requirements of the 21st Century Cures Act, with a listing of committee members. This will all be present online until the work of the group is done, and they will regularly update the status. There is a place on the HHS website where comments can be submitted, and he suggested that we send those comments to the tick-borne disease mailbox.
We then went on to discuss our proposed vision and mission/values statement. After much discussion, in an attempt to reach the “ideal future state (of tickborne diseases in the United States) “, we arrived at a temporary mission statement: “a nation free of tick-born disease and associated chronic diseases (I put in the words chronic diseases secondary to Lyme’s ability to imitate a broad range of chronic illness including Chronic Fatigue Syndrome, Fibromyalgia, autoimmune disease, and neuropsychiatric disease including dementia), where new infections are rare, and patients are restored to full wellness with patient centered, data driven, accessible and affordable care”. I think this sums up a worthy goal of the working group. The compassion of the group was evident, and is reflected in our mission statement.
The final part of the meeting was work plan development, discussing the potential role of subcommittees, the types and number of subcommittees, identification and selection of subcommittee members, and how to ensure that membership is balanced with coordination of efforts of the working group. There will be a call regarding subcommittee meetings on December 18, with minutes and transcripts on December 22. The call for subcommittee nominations closes on January 1 and will be decided between January 17 and the 26th. The subcommittees will then start doing their work. They will include public comment, literature reviews, and inventory of federal activities, gaps and duplications of efforts and potential solutions. An inventory report will be 30 days afterwards and a draft of the subcommittee report will be due in May. Another draft report with recommendations will be due by June 15, with revisions of the report by July. The draft report will be released for the public and agencies on August 18, and public comment and agency review will be by September 18, 2018. The review and summarize in the public comments will then take place on October 18; document revision on November 18; and we will submit the report December 1st. The subcommittees therefor have 3 to 4 months to accomplish a huge amount of work!
Subcommittees that will tentatively be formed include:
1. Vectors and prevention and surveillance, including vaccines and therapeutics
2. Pathogenesis, transmission and treatment
3. testing and diagnostics (lab and clinical) which will include a focus on pathogenesis, transmission and treatment including immunotherapy
4. Access to care services and support to patients
5. Vaccines and therapeutics
6. Other tickborne diseases and co-infections (which one do you think I might be serving on?)
Subcommittee members will include those with a broad diversity of opinion, and be inclusive of those with different areas of expertise, with each subcommittee containing at least 2 members from our working group. It will include opinions from patients with scientific and clinical data and there will be a maximum of 8 to 10 members per subcommittee. It will probably be one federal and one nonfederal member and each committee to try and have a balance. Individuals can self-nominate or be nominated and there may be an ex officio on the group. The designated ex officio however will not vote. Everyone else will vote on the subcommittees. The members can come to the chair if there is a problem and there will be votes on their own working assignments. A chair and vice chair or co-chair will be established for each subcommittee, and there will be some flexibility, with one patient perspective per committee. We can put in nominations by contacting the chair and vice chair of our group. Ben Beard from the CDC also let us know that someone from his agency could give us an overview of a previously formed non-FACA tickborne working group, so we can see what has already been done and discussed.
During this discussion, Pat Smith brought up the fact that we would like to get interagency support with open communication, especially between our tick-borne working group, HHS, and the CDC. There was previously an HHS webinar discussing Lyme persistence and Pat discussed having it sent to everyone. There is also a CDC sponsored educational program called LymeCore, and she asked for us to review it. Members of the public who were familiar with it, told me that it contained conservative CDC policy, upholding IDSA guidelines. This is something I would like the committee to review, and the something the public should comment on. Now that we have this working group, with the IDSA guidelines no longer being on the CDC site or national guidelines clearinghouse, I do not feel it is appropriate to be spending taxpayer money in the LymeCore program, educating physicians with outdated guidelines that do not work in clinical practice. This program should be updated as the federal tickborne working group comes up with new recommendations.
There will be a professional team helping with the reports of the subcommittee and will be bringing in experts to identify gaps in our knowledge and where we need to do the work. HHS will help us to compile resources for the subcommittees, although the reports don’t necessarily go into the Federal Register.
The meeting adjourned at 4 o’clock, and I spent time afterwards with committee members, healthcare providers and members of the public. They all shared their gratitude and new-found hope after listening to 2 days of meetings of the Federal Tick-Borne Disease Working Group. I’m encouraged by what I heard, and having now met the members of the working group, I’m certain that we going to accomplish our goals and help the American public solve this emerging health care threat. I want to express my deep sense of gratitude to John and Kristen, the chair and vice chair of these meetings, and all the members of the committee who did a wonderful job. Rich Wolitski and Jim Berger were especially helpful in answering all questions.
We are now empowered to make change. Your suffering has been heard. We will work on your behalf until we finally solve the emerging threats of Lyme and associated diseases. I feel gratitude to be in the position that I am in, able to share my 30-year experience of diagnosing, treating, and helping those who have suffered with tick-borne illness. Hope is no longer ephemeral. It is here today, and we have all witnessed it. God bless you all and God bless America. We have all witnessed democracy in action.
Disclaimer: in this and all future FB posts, I am posting as Dr Richard Horowitz, and not representing the official views of the Federal Tick-borne Working Group. If there is an official announcement from the group, it will be identified as such. said...