US Naval War College Professor Combats Harmful Lyme Myths
Dr. Montgomery McFate, Professor, U.S. Naval War College, published, “The Myths of Lyme Disease: Separating Fact from Fiction for Military Personnel,” in Joint Force Quarterly, 100, Feb. 16, 2021.
Dr. McFate addresses, in the well-cited article, many damaging myths regarding Lyme that have proliferated in the medical system since its discovery over 40 years ago. She describes how these myths harm military personnel, a population that is particularly at risk for exposure to Lyme disease. She presents several stories of military personnel harmed by Lyme and tick-borne diseases.
Military members are at higher risk of exposure to Lyme disease because service members, along with their families, live, work, and play on bases where Lyme is rampant. McFate writes, “Some 75 percent of all U.S. military installations are located in states where 99 percent of the approximately 500,000 tickborne disease cases reported to the Centers for Disease Control and Prevention (CDC) from 2004 to 2016 occurred.” Additionally, veterans often retire in rural counties where Lyme disease incident rates are higher due to ample forestation, damp conditions, and mid-range temperatures.
According to McFate, “In short, Lyme disease has already reached epidemic proportions in the United States, and the situation will certainly get worse. As the disease spreads, military personnel, veterans, and their families will be at even higher risk for contracting the disease.”
The author tackles the myth, “Lyme is not that severe,” and elaborates on the serious potential impacts that Borrelia burgdorferi can have such as penetrating the heart, crossing the blood-brain barrier, infecting the central nervous system, as well as the serious complications caused by transmission from pregnant mother to unborn baby. McFate also addresses the serious issue of increased risk of suicide amongst military members and veterans.
When it comes to “Lyme is easy to diagnose,” McFate emphasizes the lack of knowledge many VA doctors have regarding Lyme disease as well as inadequacies with the two-tier testing used by most doctors. She explains, “This two-tier diagnosis system was never intended to be used for the diagnosis of Lyme disease. Rather, it was developed by the CDC as a ‘surveillance case definition,’ which is ‘a set of uniform criteria used to define a disease for public health surveillance’.”
The common misconception, “Lyme is easy to treat” with the standard medical practice prescribing 28 days of antibiotics is also addressed. “Unfortunately,” McFate writes, “In more than 50 percent of cases, Lyme disease is not cured by a single round of antibiotic therapy.” She goes on to explain a common phenomenon that those with chronic Lyme disease know all too well, “Individuals may appear to respond well to the initial treatment with antibiotics and experience a relief of symptoms, but then relapse either months or years later.” It has been estimated that the number of people in the US suffering from PTLD exceeded 2 million at the end of 2020.
McFate calls attention to the work of the Tick-Borne Disease Working Group (TBDWG) and their 2018 report to Congress noting that, “progress has been hampered by a lack of attention at the Federal level and by divisions within the field.” She explains that, despite the widespread proportion of Lyme disease in the US, Federal funding for tick-borne diseases is considerably less per new case than for other diseases.
The author concludes that new basic research into Lyme and the repurposing of existing drugs such as disulfiram provide hope for patients. She emphasizes that, currently, there is no cure and no simple treatment for this serious and often debilitating disease. McFate writes, “Given the dire health consequences, the poor diagnostic tools, the effects of climate change in increasing tick habitats, and the endemic nature of the disease in geographical areas where the military lives, works, and plays, Lyme should be a serious concern for the entire joint force.”
Tick-Borne Disease Working Group Reports (2018 – 2020)
The Tick-Borne Disease Working Group (TBDWG) was established by the 21st Century Cures Act to improve federal coordination of efforts related to tick-borne diseases. The TBDWG’s purpose is to review federal activities and research related to all tick-borne diseases and provide a summary of its findings and any recommendations regarding changes or improvements to such findings to the HHS Secretary and Congress every two years.
The first report was submitted to Congress in November 2018; the second report was submitted in January 2021, both authored by the TBDWG members.
Subcommittee Reports were also written in 2018 and 2020, some coauthored by Working Group member and LDA President, Pat Smith.
Each subcommittee of the Working Group identified priorities and developed a report to the TBDWG that described current efforts, gaps in research, and potentials actions relevant to their topic.
Topic development briefs were also developed by the first term Working Group
HHS Tick-Borne Disease Working Group 2020 Report to Congress Now Available
The Tick-Borne Disease Working Group 2020 Report to Congress is now available (Report). The Report was presented to the Secretary of Health & Human Services in December 2020 by the Working Group (WG). The Secretary sent the Report to the Energy & Commerce Committee in the House of Representatives and the Health, Education, Labor, and Pensions Committee in the Senate at the end of January 2021. As required, the Report is now on the HHS website click here. The above process is required by the portion of the 21st Century Cures Act that created the WG.
This second term of the WG often had contentious meetings primarily focusing on material on chronic Lyme disease (CLD) and the problems with patients who have CLD in obtaining treatment and reimbursement in Chapter 7. The federal agencies charged with healthcare do not accept CLD as an entity, thus coming to consensus was often difficult for the WG. Several Minority reports are contained within the WG report that deal with those Lyme disease patient issues, including diagnosis.
The Report has chapters which include Tick Biology, Ecology & Control; Clinical Manifestations, Diagnosis & Diagnostics; Causes, Pathogenesis & Pathophysiology; Treatment; Clinical & Public Education & Access to Care; Epidemiology & Surveillance. The report contains a significant amount of information on other tick-borne diseases.
LDA President Pat Smith served two terms as a public member of the Working Group in the advocate/family member of patient categories as delineated in the legislation.
On January 14, 2021, The National Institute of Health (NIH) COVID-19 Treatment Guidelines Panel issued a change in position and are no longer recommending “against” the use of ivermectin for the treatment of COVID-19. This “permission” was issued 8 days after Drs. Paul Marik and Pierre Kory, founding members of the Front Line Covid-19 Critical Care Alliance (FLCCC), along with Dr. Andrew Hill, researcher/consultant to the World Health Organization, presented their data on ivermectin before the Panel, showing significant benefits of ivermectin in prophylaxis, early treatment and late-stage disease.
The NIH Panel stated that there is insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19, and that more clinical trials are needed. The FLCCC responded to the Panel in a public statement, dated January 18th, expressing gratitude for the Panel’s neutral stance on ivermectin. However, they questioned the Panel’s caution and criticism of the existing evidence, especially in the midst of escalating hospitalizations, and deaths from COVID-19.
In their response, FLCCC stated that both monoclonal antibodies and convalescent plasma therapies are also regarded as neutral, and are used widely in COVID-19 treatment in the U.S., but are inferior to ivermectin in 3 critical ways:
1) Ivermectin is the ONLY one of these 3 therapies that has multiple randomized controlled trials (RCT’s) and a meta-analysis of RCT’s that demonstrate statistically significant reductions in mortality rates; shorter durations of hospital stay; profound reductions in the infectivity rate in both pre-and post-exposure prophylaxis studies; faster times to clinical recovery; and faster times to viral clearance.
2) Ivermectin is the ONLY one of these 3 therapies that is globally available, low cost, given orally, requires no special shipping or handling, and is safe to use in nearly all clinical situations.
3) Ivermectin is the ONLY one of these three therapies that can be widely used in both early outpatient treatment as well as in prevention.
NIH Panel also stated that some clinical studies showed no benefits or worsening of disease after ivermectin use; however FLCCC objected, showing evidence of flawed studies. NIH Panel also listed “limitations” preventing them from making a stronger recommendation. FLCCC disagreed with these limitations. (See Public Statement)
FLCCC concludes: Ivermectin is one of the safest, low-cost, and widely available drugs in the history of medicine. The evidence in favor of ivermectin includes approximately 32 controlled trials, 20 of them RCT’s. Similar meta-analyses of these trials have been performed worldwide, concluding that ivermectin is a highly effective therapy for COVID-19 and/or should be widely adopted for use.
FLCCC: “Why does the Panel’s opinion diverge from these other expert meta-analyses? Further, why does the Panel’s opinion diverge from the expert peer reviewers (two of whom we were told were FDA employees) that has now accepted our manuscript and its conclusions for publication? …Patients do not have time to wait, and we as healthcare providers in society do not have that time either. We plead with the Panel to rapidly re-review and re-consider the current strength of their recommendation.”
NY Supreme Court Judge Orders Hospital: Give Patient Ivermectin for COVID-19
According to “TrialSite News” on January 21, “Apparently, a judge just ordered the Millard Fillmore Suburban Hospital to allow an 80-year old woman to be treated with Ivermectin. A New York Supreme Court judge ordered hospital to allow her to be treated with Ivermectin for COVID-19. Ivermectin, which had been administered in the ICU with noticeable symptom improvement was discontinued when the patient was moved to another unit in the hospital. Family members took legal action after the doctor in the new unit disallowed the use of the drug, and the woman’s health condition again declined. Family members immediately involved lawyers and legal action to resume treatment. Judge, Henry J. Nowak aligned with the family.
Ivermectin is approved for fighting parasites and lice. NIH states that in general, the drug is well tolerated and is currently being evaluated as a potential treatment for COVID-19. However, is not yet approved for use by the US Food and Drug Administration (FDA).
The COVID-19 Treatment Guidelines Panel (the Panel) has determined that currently there are insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19.
County-Level Distribution of Ixodes and Lyme Disease Spirochetes in US
This new summary article by employees of the CDC, presents the first county-level map of the distribution of Lyme disease spirochetes in host seeking Ixodes ticks between 2004-2019 in the contiguous United States. Data compiled for this summary was from literature searches; publicly available tick-borne pathogen surveillance databases (ArboNet Tick module); and internal CDC pathogen testing databases to map the county-level distribution of Lyme disease spirochetes reported in host-seeking Ixodes pacificus and Ixodes scapularisacross the contiguous US.
Investigators narrowed their search to include only host-seeking ticks, because ticks in this state are most likely to bite humans, and because host-seeking ticks provide enhanced spatial precision compared to ticks collected from mobile hosts. Data used was restricted to studies that collected ticks by flagging, dragging or CO2 Traps. Ticks that were collected from mobile hosts such as wildlife, pets, and livestock were excluded because county of exposure could not be confirmed. County level pathogen infection data was included from these sources when provided.
Authors report B. burgdorferi s.s. infected I. scapularis from 384 counties in 26 eastern states of the Northeastern, North Central and Mid-Atlantic regions. B. burgdorferi s.s. infected I. pacificus were reported from 20 counties 2 western states, primarily from northern and north-coastal California. Borrelia mayonii was reported in I. scapularis in 10 counties in Minnesota and Wisconsin, where records of B. burgdorferi s.s. were also reported.
Important caveats that the authors state in regard to this mapping effort:
” The reported distribution of B. burgdorferi s.s and B. mayonii in host seeking ticks is almost certainly an underestimate of the actual distribution of these disease agents.”
“Though support for and participation in tick and tick-borne pathogen surveillance has increased in the US in recent years, collection and pathogen testing efforts have been limited with most efforts focused on US regions where Lyme disease cases are most commonly reported.”
“In some instances, lack of records could represent lack of sampling effort or low prevalence of pathogens within sampled tick populations.”
The authors were confident in the distribution of tick presence records, but for counties where Lyme disease spirochete has not been documented in ticks, they were unable to determine whether this represented a true absence of pathogen or a merely a failure to detect the pathogen. Lack of data is especially evident in the Rocky Mountain region, Western plains and Southwestern region in regard to both tick presence and pathogen detection; and in the Southeastern region and Western states for pathogen detection. Continued surveillance and reporting will likely result in additional counties to be added to the map, and reporting densities of infected host-seeking ticks for many jurisdictions may be possible in the future.
In comparison to a broad distribution of vector ticks, the resulting map shows a more limited distribution of Lyme disease spirochetes.
LDA NOTE: Contained in the journal article: This work is written by (a) US Government employee(s) and is in the public domain in the US.
Read full article here
Amy C Fleshman, Christine B Graham, Sarah E Maes, Erik Foster, Rebecca J Eisen, Reported County-Level Distribution of Lyme Disease Spirochetes, Borrelia burgdorferi sensu stricto and Borrelia mayonii (Spirochaetales: Spirochaetaceae), in Host-Seeking Ixodes scapularis and Ixodes pacificus Ticks (Acari:Ixodidae) in the Contiguous United States, Journal of Medical Entomology, 2021;tjaa283, https://doi.org/10.1093/jme/tjaa283
New Estimates of People Diagnosed/Treated for Lyme: 476,000 Annually
476,000 People Diagnosed & Treated for Lyme Annually:The Centers for Disease Control and Prevention (CDC) published in the February edition of its Emerging Infectious Diseases two new papers pertaining to Lyme disease.
CDC states on its How Many People Get Lyme Disease? webpage (reviewed Jan 13, 2021), “A recently released estimate based on insurance records suggests that each year ~ 476,000 Americans are diagnosed & treated for Lyme disease.1,2 This number is likely an over-estimate of actual infections because patients are sometimes treated presumptively in medical practice. Regardless, this number indicates a large burden on the health care system and the need for more effective prevention measures.”
The researchers found ~ 476,000 people are diagnosed with and treated for Lyme disease each year in the U.S. The prior Lyme estimates by CDC from 2005 to 2010 indicated “~300,000 people get Lyme disease each year.” Both estimates are based in part on insurance claim data. Based on CDC’s estimates the LDA calculated a 59% increase in the estimated number of people diagnosed & treated for Lyme disease annually. (See Fig. 1)
The CDC clearly states on its website, “It’s important to emphasize that 476,000 is the estimated number of people treated for Lyme disease and likely includes some patients who were not actually infected.” Read the two papers below for their discussion on this new estimated number.
The two 2021 research papers on which the new 476,000 estimate is based are:
According to a CDC official, “Unlike some tickborne disease surveillance data, the data shown in the charts [on the above webpage] are updated weekly, rather than annually. These data can indicate when people in different parts of the country might be at highest risk for tick bites. We think this is the closest we have come to providing real-time risk data for tickborne diseases ….” CDC also indicated they are working with data providers to make this type of data state-specific verse region-specific.
Syndromic surveillance is a term unfamiliar to the general public. In its September 2004 MMWR CDC describes syndromic surveillance, “Although syndromic surveillance was developed for early detection of a large-scale release of a biologic agent, current surveillance goals reach beyond terrorism preparedness. Medical-provider reporting remains critical for identifying unusual disease clusters or sentinel cases. Nevertheless, syndromic surveillance might help determine the size, spread, and tempo of an outbreak after it is detected (5), or provide reassurance that a large-scale outbreak is not occurring, particularly in times of enhanced surveillance (e.g., during a high-profile event). Finally, syndromic surveillance is beginning to be used to monitor disease trends, which is increasingly possible as longitudinal data are obtained and syndrome definitions refined. The fundamental objective of syndromic surveillance is to identify illness clusters early, before diagnoses are confirmed and reported to public health agencies, and to mobilize a rapid response, thereby reducing morbidity and mortality. Epidemic curves for persons with earliest symptom onset and those with severe illness can be depicted graphically …
Stakeholders need to understand the advantages and limitations of syndromic surveillance systems. Syndromic surveillance systems might enhance collaboration among public health agencies, health-care providers, information-system professionals, academic investigators, and industry. However, syndromic surveillance does not replace traditional public health surveillance, nor does it substitute for direct physician reporting of unusual or suspect cases of public health importance.”
Lyme Disease Association, Inc. (LDA) Response: It is important that data surrounding Lyme and other tick-borne diseases be continuously collected and distributed to safeguard the health of the public. Since the above material has just been released by the CDC, the LDA will review the material and comment further if necessary in the near future.
LDA Pres: Last Remarks to Working Group on Suppression of Chronic Lyme
On her last day as an HHS Working Group (WG) member, after serving 2 terms, Lyme Disease Association President Pat Smith addressed at the Dec. 2 online WG meeting, her concerns about the procedures of the 2019-2020 Working Group and her concern that the interests of patients were not served by the group. Read below or listen to her audio comments (LINK)
Pat Smith’s written closing words to WG on Dec. 2, 2020 (actual verbal may have varied slightly)
THANKS WG 1: Since this is the last WG meeting for me, I first want to thank the entire 2018-19 Working Group I served on including staff and subcommittees. Working together, WG 1 produced a powerful report which incorporated the issues that were important to patients. Congratulations for that achievement. I was excited for progress for patients who had hope for the future.
THANKS WG 2: Now I want to thank public commenters & Jim & Kaye and all the current subcommittee members who worked so hard to lay groundwork for the backbone of the 2020 WG report and those current Working Group members who demonstrated their commitment to supporting long suffering chronic Lyme patients. I especially thank my Chapter Co-Chair, Captain Scott Cooper, an advanced practice provider from CMS, who worked tirelessly and selflessly to help patients.
PROBLEMS: Unfortunately, and I would be hypocritical if I said otherwise, despite these efforts, this report will do little to help patients. It was flawed from the onset; the WG member selection was cloaked in secrecy, about who they were. If we did find out, we were not permitted to release names. When IDSA unilaterally publicly announced the appointment of Eugene Shapiro to the WG, speculation was rampant as to who was really in charge of this WG. The handwriting was on the wall. It was no surprise when Dr. Shapiro, an author on the last IDSA guidelines, was permitted, without WG discussion or knowledge, except by Chairman Walker, to give his proxy vote to Walker, when he missed meetings, thus violating the concept of having members with diverse viewpoints sitting at the same time, same meeting, in public under FACA, having discussions to reach consensus on a report to Congress.
Since Meeting 1, when Chairman Walker, a Rickettsia expert, announced that Lyme had already been done by the first WG, and this WG would do a brief update on Lyme and concentrate on other TBDs, it was clear the patient interests would be targeted. Each meeting the patient chapter was rigorously scrutinized and held to a different standard than the other chapters.
Attempts were first made behind the scenes to allow anyone to write a minority report before any consensus vote was taken, although through a vote, the majority of the WG did not allow that to happen. 2 weeks ago, the tenor of the report discussion changed to an entire rewrite of our chapter, devolving into a real “food fight.” A motion to keep the Chapter as it was, passed 8-6. 3 minority reports have been produced for that chapter, including the 3 government agencies objections, CDC, NIH, FDA.
WHO’S IN CONTROL: The government agencies have been forced to take a public stand against the Patient Chapter, dismissing chronic Lyme disease and continuing the denial of treatment to sick Lyme patients, alongside their partners in a powerful medical society, one whose new Lyme guidelines were just released two days ago. Their public talk has centered on what is good for the patient, but their decisions do not reflect that sentiment. The question thus becomes, whose interest was this panel designed to serve: those of the patients who for two decades fought to pass the enabling legislation for this panel to help focus on their plight, chronic Lyme disease, or for medical specialty society special interests.
LYME IS MARGINALIZED: Other diseases are treated seriously. HIV researchers developed a gold standard test within a few years, Lyme still has none. Leprosy has had more clinical trials than Lyme disease, which ranks 14th out of 15 diseases in infectious diseases trials. Within 9 months, COVID 19 had several treatments, tests and upcoming vaccines. To the Lyme patients, I am so sorry you have been again marginalized by those charged with your health, but we gratefully thank any current Working Group members who worked hard to provide the help you so desperately need.
I leave you all with a quote from the late Issac Asimov, noted author:
“Your assumptions are your windows on the world. Scrub them off every once in a while or the light won’t shine in.”
These windows haven’t been scrubbed in almost 46 years. Thank you.
Click to listen to Pat Smith’s Final Remarks to the TBDWG:
House Lyme Disease Caucus 2020
The House Lyme Disease Caucus is a bi-partisan group working together in Congress to take action on Lyme & tick-borne diseases. Under the leadership of Congressmen Chris Smith (NJ) and co-chair Colin Peterson (MN), it has initiated letters and actions to benefit Lyme patients, such as the inclusion of the monies for Lyme & tick-borne diseases into the Congressionally Directed Medical Research Program (CDMRP) and language and Lyme monies into Appropriations over the years and initiated favorable legislation. Additionally, it has queried government agencies over policies not favorable to patients. This has reminded the agencies that someone is looking over their shoulder. Many meetings have been held and educational sessions in DC for Congress.
If Representatives are interested in signing up they can contact the offices of Congressman Christopher Smith (NJ) or Colin Peterson (MN).
List of Current House Lyme Disease Caucus
Smith, Christopher H. (R-NJ-04), Co-chair
Peterson, Collin C. (D-MN-7), Co-chair
Cohen, Steve (D-TN-9)
Connolly, Gerald E. (D-VA-11)
Courtney, Joe (D-CT-2)
DeGette, Diana (D-CO-1)
Delgado, Antonio (D-NY-19)
Hartzler, Vicky (R-MO-04)
Higgins, Brian (D-NY-26)
Holmes Norton, Eleanor (D-DC)
Keating, William R. (D-MA-9)
Kennedy, Joseph P. (D-MA-4)
King, Pete (R-NY-02)
Krishnamoorthi, Raja (D-IL-08)
Langevin, James R. (D- RI-02)
Lofgren, Zoe (D-CA-19)
Malinowski, Tom (D-NJ-7)
Maloney, Sean Patrick (D-NY-18)
McGovern, James P. (D-MA-02)
Moulton, Seth (D-MA-06)
Peters, Scott (D-CA-52)
Pingree, Chellie (D-ME-01)
Pocan, Mark (D-WI-02)
Posey, Bill (R-FL-8)
Reed, Tom (R-NY)
Rose, Max (D-NY-11)
Stefanik, Elise (R-NY-21)
Steil, Bryan (R-WI-01)
Thompson, Glenn (R-PA-15)
Tonko, Paul (D-NY-20)
Wexton, Jennifer (R-VA-10)
Wittman, Robert J. (R-VA-01)
More about the Caucus
The bipartisan Congressional Lyme Disease Task Force, co-chaired by Rep. Chris Smith (R-NJ) and Rep. Collin Peterson (D-MN), is dedicated to educating Members of Congress and staff about Lyme and other tick-borne diseases, as well as advancing initiatives that are designed to help the estimated 400,000 Americans who develop Lyme disease each year and all of those living with the disease.
As co-chairs of the bipartisan Task Force, Rep. Smith and Rep. Peterson lead annual appropriations requests in support of Lyme disease research through the Department of Health and Human Services and for research funding at the Department of Defense. In 2015, the caucus secured for the first time ever, $5 million in funding in the House Appropriations Committee annual military spending legislation, which was adopted in the Fiscal Year 2016 funding bill which was signed into law, and will provide resources for Lyme disease research through DOD’s innovative, high-risk, high-reward program. Subsequently, the CDMRP continued to be funded, and $7 million was secured for 2020.
The caucus helped advocates secure another major win for Lyme disease. In December of 2016, the United States House of Representatives passed, and former-President Obama signed, the 21st Century Cures Act. The Cures Act included language – similar to a bill that Rep. Smith introduced previously – which created the interagency Tick-Borne Disease Working Group. Specifically, the Working Group (WG) under the auspices of HHS, is comprised of federal and non-federal members tasked with reporting to Congress on scientific advances, research questions, surveillance activities and emerging strains in species of pathogenic organisms. Patients, advocates and treating physicians sit at the same table with government officials. In 2018, the WG sent a report to Congress with recommendations on Lyme and other tick-borne diseases.
11th Hour Attempt to Commandeer & Rewrite Patient Chapter Fails
BACKGROUND: The 17th Working Group Meeting turned out to be a referendum on the Patient Chapter of the upcoming 2020 Working Group report. The previous 9 months of the WG had seen that chapter content consistently eroded by comments from just a few WG members which forced shortening of chapter, removal of material, rewriting of material, and moving around of material. The terms “chronic Lyme” and “persistent Lyme” could not be used and had already been removed. Now, more changes and even a complete chapter rewrite were called for. Differences in IDSA Guidelines, LDo’s patient registry information, shared decision making permitting doctors to tell patients about different treatments, and peer review that questioned conclusions of the NIH studies were all under attack and subject to removal/more revisions after 9 months of scrutiny and changes made to accommodate numerous objections each meeting.
Chapter Co-Writers Pat Smith & Scott Cooper refused to do any more changes. A Donta/Smith motion was made to accept the Chapter as written (with one clarification). It was voted on after about an hour of often contentious discussion including a rebuttal to the NIH objections (already previously addressed) to the chapter by Smith“…“the 11th hour and what is (a) surprise, you want to deep-six the report. The only report that addresses what happens with patients. I’m sorry that you think the NIH is sacrosanct. So much that the bodies of people that were charged with doing research and talking about what research should be done were not even willing to take in chronic Lyme disease research. That’s why we couldn’t get it done or published. That’s happened for years. … I happen to think that we have to do something for the hundreds and thousands of people over the years that have been affected. The government doesn’t want to do anything about it, so I don’t know why you’re sitting at this table if you don’t want to do something. We have compromised plenty and removed tons of stuff…. Compromising on the fact that Lyme disease is the most prevalent tick-borne disease affecting the most people, and it’s more people who aren’t able to get treated because the government doesn’t want to recognize they are sick. You want to send them all to psychiatrist.”
TECHNICAL DIFFICULTIES WITH TRANSCRIPT BELOW: The following article provides quotes from the automatically produced transcript downloaded during the WG meeting. The transcript often contains inaudible/ garbled material due to HHS meeting software/phone connections. Where possible, LDA has listened to the audio recording and supplied the actual word(s) in parenthesis. So that the dialogue presented makes sense, sometimes a sentence between quotes in italics is provided by LDA, indicating other WG discussion took place. The bolding in quotes has been done by the LDA to emphasize the most significant lines. You can listen to the actual audio transcript of Pat’s Smith Rebuttal at the bottom of this article. (click here)
Actual Dialogue of Pat Smith’s Rebuttal to Attempt to Rewrite/Remove More Material From the Chapter 7 Patient Report: The following section is from the audio/written transcripts downloaded from the Working Group meeting.
WALKER: You’ve taken advantage of being office (AUTHOR) of a chapter to launch into topics that have nothing to do with the chapter that you don’t want to put into the report. It has nothing to do with supporting the recommendations of the chapter.
COOPER: They do support it, plus as Jim noted with the charter of the working group, one of the things is affordable access for patients to care that stores health.
WALKER: You need to get that into recommendations. And I hope to do it because you have not done it effectively at all, anything to do with access to care for the recommendations of this chapter.
SMITH: I don’t think so David. We’ve done this for many hours. Hours and hours. More than probably the rest of the working group reports put together. We addressed these comments that don’t have any real specific asks, it doesn’t support, it’s been all the way through. I don’t think we need to go any further. I think we have done our part, and we are willing to move along because we don’t feel that we need to discuss this any longer.
WALKER: You took two and half hours to delay moving to the meeting and that is what took all the time from the last meeting.
SMITH: Excuse me, that was not my issue. Because you work behind the scenes to change protocols, and then you did not want that brought up in public. I brought it up, and I’m very happy that I did.
DIXON: Further discussion of individual comments is not going to get us any further. I think we have had ample communication and differences of opinion have been expressed, but we have not come to consensus, so we need to vote on the overall chapter, because it’s not the individual comments of the overall some of the balance of the chapter. I feel there’s not an overall balance of the chapter and I’m uncomfortable on the lack of balance and the misrepresentation or the depiction of the clinical trials overall. They are listed as preempts there is trials done and two additional trials done under grant it’s the overall focus on the minority finding of those studies rather than the overall preponderance of evidence adding to that the overall depiction I think that’s a good way to characterize. I think what we need to do is call to a vote and see how many people feel that way and how far apart we are before wasting additional time on individual comments that really aren’t the point.
SMITH: I would say Dennis, thank you for your honesty and I know you’re espousing what the party line is. The party line for 46 years has been let’s bury the patient’s.I’ve worked for 36 years and (AS) an advocate for those with chronic Lyme disease and I have never in my life seen the hatred that I’ve heard from some people in this group over providing information that is totally verifiable. We have sources coming up but you don’t want to accept them. David doesn’t want to accept the (THEM) or Schapiro. I don’t know who else want to accept them. Nobody else gets the same scrutiny.
This group was willing to accept a 1904 piece of citation in this report. But we have citations coming up in the best institutions over many years, and you don’t want to accept it.
…you can’t say chronic or persistent Lyme (EXISTS). I think the community is tired of it.
So now we get to the 11th hour and what is (a) surprise you want to deep-six the report. The only report that addresses what happens with patients. I’m sorry that you think the NIH is sacrosanct. So much, that the bodies of people that were charged with doing research and talking about what research should be done, were not even willing to take in chronic Lyme disease research. That’s why we couldn’t get it done or published. That’s happened for years…The NIH is not sacrosanct.
I happen to think that we have to do something for the hundreds and thousands of people over the years that have been affected. The government doesn’t want to do anything about it, so I don’t know why you’re sitting at this table if you don’t want to do something. We have compromised plenty and removed tons of stuff.
Compromising on the fact that Lyme disease is the most prevalent tick-borne disease affecting the most people, and it’s more people who aren’t able to get treated because the government doesn’t want to recognize they are sick. You want to send them all to psychiatrist. I’ve had people who I know personally that have been put into institutions and weren’t able to be treated (for Lyme disease)…This includes children. I’m sick of it. I saw children seizing in the 90s from Lyme disease and hospitals…It’s a tragedy that’s gone on too long. Somebody has to do something.
I had higher hope that this group was going to be able to do something and I am disappointed. I shouldn’t be, because my hopes should not have been that high…I agree that we need to do something for these people who are suffering.
DIXON: That’s why I’m so committed to the resource section on how we need to explore and understand better the pathogenesis and suffering of the individuals, so that we can intervene with the most appropriate methods (in a scientifically rigorous fashion.)
SMITH: (You had 46 years to do the pathogenesis and get it solved. Let’s look at COVID. Let’s see what was done) in the 9 months time. (….Look what has been done just in that time period.) You had 46 years. And what did you do. You covered up a disease. I remember it from the 80s, from the 90s, you tried to cover it up as a disease you try to cover it up as a (IT) spread, then you went and covered up (Babesia) where it was. And it isn’t just CDC, it’s the NIH, too. It’s about time somebody stood up and said we have to do something that directly impacts getting help for these people.
DIXON: We are trying to uncover, not cover the mechanisms (of pathogenesis and understand the basic transmission) and clinical means to address that.
SMITH: And you didn’t have time enough or money enough. I saw the inventories. I know what you did. I know what you should’ve done. But no, that was not done. I only saw a couple of years of those inventories and so you’re never getting to the bottom line. People said it this morning. Where’s the help for the patient. There is none and now you want to remove their chapter? Well go ahead.
I’m going to tell you what — we’re going to do things with Congress that this group cannot do. Because it’s obvious that some of you don’t want to do it. And again please, the other people in the group, and you know you are, I’m not speaking to you right now. I’m speaking to these people who have prevented this from moving forward. It’s just unbelievable to me how a few pages of the chapter have been so attacked.
LDA comment: The below references MyLymeData registry…
WALKER: I believe the survey you did and there really is exemplary of a group of people, thousands of people that you’ve surveyed who are suffering and they definitely need to be helped and we don’t really know what’s wrong with them. The problem is they are self-reported saying that they believe they have persistent Lyme disease.
SMITH: If you would have listened to the prior meeting, (David you would have heard)
WALKER:They really don’t… they just say they’ve had Lyme disease, and the high rates of co-infection with respiratory illnesses like mycoplasma and (Bartonellosis)…These people definitely do need help but the help may not be Lyme disease. And if it is Lyme disease we need to understand how.
SMITH: We discussed this patient registry… The people in that registry were asked if they had the doctor diagnoses, and if they did not they were removed from the registry. There’s tons of patient registries and you just want to pick on this one because it doesn’t meet your needs. This is typical…But the rest of the patient registries of the world that the NIH have or that the CDC have or other agencies or other respected institutions have. You don’t come out and say anything about those. Those registries are used everywhere. You only care because this one shows the true extent of problems across the United States and across the world. You’ve had 46 years to do the research about what’s wrong with these people if this isn’t what they have.Not only have that (HAVEN’T YOU) done it, you’ve relied on mainstream medicine, which means they can’t get more treatment in any way shape or form. They are not permitted. They are told to go to a psychiatrist, even alternative medicines, (Nope, forget it you can’t.) That’s unconscionable, unconscionable.
DONTA: I move that this chapter be accepted with possible minor revisions.
WALKER: Sam would you be willing to break that into two sections on the recommendation and the content of the chapter?
SMITH: He cannot, because we’ve already voted on the recommendations.
DONTA: That is a part of the chapter David. So unless we want to hear from other members of the working group, my motion stands that we move to accept Chapter 7 into the report.
SMITH: I second that.
SOLTYSIAK:…So now is (AS) a working group at this 11th hour. We are supposed to compromise and decide (WHAT) we want to represent. And guess what. We have that opportunity for the minority report. If we voted something down, we can choose to still put them in our (MINORITY) report (GOING) forward. I think we just have to agree to the process…
SMITH: That’s correct. I would certainly be very happy that we proceed on this boat (VOTE). And if it goes down, I’d love to be able to present to Congress how this working group voted against a chapter, the one for the patient’s. And the one that the patient had that (THE) input into, and had it well-crafted and well done, and spent hours of discussion on, then I’d be very happy to do that, and we will do that (IF THAT HAPPENS). So let’s move on and get the boat (VOTE) going.
Some more procedural comments made by Donta, Soltysiak, Dixon, Berger
SMITH: I would like to say something about the fact that these comments that are put in here, were put in here by David. They are the same, (COMMENTS THAT HAVE BEEN) in there before, in the last meeting. And he didn’t put these comments in there (TODAY). So therefore, he cannot go back now and put these comments in and expect that we need to address them. We have addressed these 1000 times over and there was no reason for them to be put in here. It was on last time’s agenda, and it was pushed, in my opinion, to the end as it always was, so that we can be sacrificed and moved again and again until now we are at a critical point. And [ MUSIC ] about this chapter and whether it will stand or not. I mean, this is ludicrous to me and I would like, and at this point, I call the vote.
SOLTYSIAK:…let’s pay attention to our tone and it also is about respect….When the processes (PROCESS IS) we have had months to come to agreement on this chapter and we don’t agree. It’s a chapter that presents many opportunities for disagreement. Therefore, the solution is, if you don’t agree, present in your vote as a minority on either the hold (WHOLE) chapter or your vote on certain sections and provide a minority report.
SMITH: That’s (NOT) what we have on the floor. The motion on the floor is to accept the chapter. We will fix the first comment because it was legitimate, it was confusing and we will fix that comment. These are the (OTHER) comments should’ve been done at the last (MEETING).
[ Indiscernible – overlapping speakers ]
SMITH: Wait a minute, excuse me. As far as tone and respect, you have got to be kidding. Let me tell you. You’ve got to be getting (KIDDING).After all the things I have heard and seen how some people have reacted to patients, to our sick patients, they are the ones that deserve to have the respect. And they have not gotten it. And so, therefore, we have a motion on the floor. I called the vote.
SHAPIRO: First of all, the motion hasn’t been seconded. Secondly, I have a question. Could somebody please clarify what the requirement is for a minority report? Is one half (DOES ONE HAVE) to reject the chapter, can one accept the chapter but object to specific content, and how does that happen because it sounds like we have only had motions to accept or reject the chapter. So Jim, can you clarify what needs to happen to have a minority report included, please?
BERGER: Okay. It’s my understanding that for a minority response there can be either a rejection of the chapter or a rejection of comments.
SMITH:That (MINORITY REPORT) has to be in response to a vote. That has to be a vote on one particular sections and that has not been done. And therefore right now we have a motion on the floor to accept or reject the chapter. If someone – states not to accept the chapter they can do a minority report, but there’s nothing right now about any kinds of sections. And so, we have a motion, Sam, motion denies seconded it. (Sam motioned it and I seconded it)
COOPER:And I would add to what Pat is saying and what Jim said. When it comes down to a vote on an entire chapter, then the dissenting opinion that’s written everything in the chapter is fair game…
— [Inaudible – static ] (COOPER COMES BACK ON)
COOPER: What I was saying is in this case where we are voting on the entire chapter, whatever way the vote comes out if you or someone who has dissented…from the majority for the entire chapter, your opinion that’s written can cover that entire chapter. If we were voting on a specific section that would be different. The opinion would have to stick to that if you were in the minority. But in this case, that’s not relevant because the motion by salmon (SAM) seconded by Pat was…the entire (CHAPTER) as is, other than the first one (CHAPTER COMMENT) we talked about with the numbers and percentages, which we [Indiscernible ] (WILL) correct.
Below, Beard is addressing a number of Working Group Members’ comments from above…
BEARD: You know, this has been — I couldn’t agree with Dennis More. Certainly CDC is clearly supportive of recommendations, and honestly, I’m not so much against what’s written here. I think it’s what’s not here, and I think it’s the whole idea of showing the balance. I mean, I am fine with registry data. But I think David makes a good point and we should point out limitations of registry data. You know, there’s truly a point and counterpoint to this and this is a dilemma in which we live and we need to work out a way to answer these questions and resolve it. But I think the way the chapter is written and LeeAnn (LEIGH ANN), to your point, I don’t think that it’s there (FAIR) to say these were 11th hour comments.It was something brought up very, very, very early on and I think can support those who have been outspoken about this, that the balance just is not been put in there and in that sense the comments have never adequately been addressed.
Again, I’m supportive. I think was (WHAT’S) in here is good, and this is (AN) incredibly important chapter. And it doesn’t need to be deleted or even rewritten. It just needs to be balanced with the other side of some of these issues. That, to me, is really the issue of debate here.
COOPER: Thank you, Sam and thank you, Ben. I will say in defense of what Pat and I have done throughout this process, I feel like we have acted in good faith to address the comments that we have gotten, all of them, unless they were just criticisms without any constructive part to it. As Sam was saying, there was nothing offered and I will say this last round, the preponderance here is just to comment this is irrelevant. And with nothing to offer, so if that needs to be pointed out, particularly to the public listening in, because they might not be able to see these comments, and since we will not go through each one, a lot of them are just that… We have addressed even those in the past. You know, to explain why it’s not irrelevant. So I think we are at really a point here. With (WE’VE) acted in good faith. We have tried to respond and work together. I think we are at a point where Sam put the motion and Pat seconded it. To either accept the chapter as it is other than that one area or, you know, to not accept it and then we will proceed from there.
DIXON: …The overall tone of an entire page is hard to fix with one or two comments, so if you just focus on the text about the NIH trials and include the European trials, which are even bigger and did the same thing, you see such things as comments about the poor design, you see inconsistencies in result, you see controversies. The results are rather consistent. I think the disparity is in the to interpretation of the results. So if you look at the very fine European trial done by [ Name indiscernible ] Goldberg and colleagues I have known Bob since the early 90s when he came into the (INFECTIOUS DISEASES ???) effect it is the them the clinical trial network that I went for 15 years. He took on the challenge of Lyme because he noted previous randomized trials have not shown convincingly that prolonged antibody treatment has been beneficial to patients. Which is true. The trials are showing that additional drugs are not beneficial and yet there’s controversy over interpreting that…
SMITH: Excuse me, Dennis, but I believe you were most meetings and if you weren’t present Sam Perdue was, and to give you both credit, you made the meetings. However, we discussed that issue very clearly and in response to those comments many, many, months ago and we said, no, we are not talking here. We are talking about U.S. trials. We are not talking about trials in other countries.We were very clear about it. We said it, we stated it, we made changes to that whole section. Many, many rounds of changes throughout that whole section and no one ever put (BROUGHT) it up again. And now, now that you guys have pushed this till the 11th and a half hour and you want it rewritten again and you want to bring up all that old stuff again, well, sorry, Dennis, but we’re not going to do that. We are not going to bring this up again. That was already discussed. You can go back and find it in the transcripts and if that’s the case but it’s there and we are not going to do this again. And I call the question, we have a motion and a second on the floor.
DIXON: Another interpretation of that is the changes that were made did not have significant impact on the concerns that were registered.
SMITH: That is not true because no other concerns were registered on that aspect after that. The only concerns that have been continuously registered are concern(s) that don’t provide anything and just say that doesn’t belong in the chapter. And so, we’ve addressed everything and then some…I know we went above and beyond the call of duty to get this to a consensus state and, you know, and then to see now, here you are, and you’re going to shoot it down.Well, please be my guest. Shoot it down, because I’m going to tell you it’s about time that this nation understood where it’s government stands online (ON LYME) disease, in particular, chronic and persistent, and those patients. I think they need to see it clearly, and believe me, this will drive it home. I’m perfectly fine to go with this and we have a motion and a second on the floor. Let’s do it.
WALKER: I have a question for you. Does the (SHARED) decision making inception (OPTION), trying to force physicians to offer (IN)effective, dangerous options to the patients?
DONTA: I disagree. David you cannot make that kind of statement without more experience. And, Dennis, you know, we have talked about the European trial, and it had a big fatal flaw which was duration of treatment. A couple of others. Let’s not presume that appropriate duration of treatment, which is the key to the critique of all of the existing trials and whether that’s correct or not remains to be seen but needs to be supportive. We can’t be dancing around that there is another cause when it’s staring us in the face…
SMITH:… David, here’s my response. First of all, it’s not my judgment. I am not a physician. I have never pretended to be one. However, I can read and I can also assess information that is provided by the tens and tens of thousands of patients and physicians across the country. And I can look at [Indiscernible] (ILADS) guidelines which were the IOM approved the way the [Indiscernible] (ILADS) were developed. They were the last ones on the national guidelines clearinghouse as a matter of fact before the government defunded the clearinghouse. Those guidelines stand up. They give the doctor the right to make a clinical decision based on what they see and also based on the kinds of testing that they do and considerations of the background and the patient’s history and the differential diagnoses etc. etc.
WALKER: I agree with that, Pat.
SMITH:And that is what our chapter talks about, basically is that there are two sets of guidelines and that… clinical judgment shall (SHOULD BE) permitted, because for heaven sakes, otherwise let’s not bother sending those guys to med school because what good is it if they are not allowed to use the (THEIR) clinical judgment, and they are basing that on guidelines that were on the national guidelines clearinghouse approved by AHRQ.
WALKER: What if the decision is dangerous and ineffective? To (DO) they had (HAVE) to present the alternative treatment?
DONTA: David, you are telling me I have been giving dangerous medications for years excessively treating those patients. Sorry to hear you say that. Please, let’s vote.
BEARD:I just wish we could address sections of this and not the whole thing, because it’s just throwing the baby out with the bathwater.
SMITH: I think that, no offense, Ben, but the government longtime (AGO) through(THREW) out the baby in the bathwater, and those were our patients. You threw them out, you left them there, and this to me just stomping all over them, so I don’t think it could get much worse.I have never spoken this way at anything I have sat on before in this manner, but I just feel like this is — it’s so ludicrous, I can (CAN’T) imagine what the people are thinking out there, but I can be pretty sure of it and it’s disgraceful. It’s absolutely disgraceful, so let’s get it over with. If you’re going to cut us out, then (CUT US) out.
The Chapter 7 vote on the motion to approve the chapter, as written with one change, was as follows:
Scott Copper*, Patricia Smith, Beto Perez de Leon*, Angel Davey*, Scott Commins, Sam Donta, Leigh Ann Soltysiak, Leith States*
Ben Beard*, Dennis Dixon*, Kevin Macaluso, Todd Myers*, Eugene Shapiro, David Walker
LDA NOTE: There are 7 federal members* and 7 non-federal public members on the working group. Members wishing to write a minority report must vote NO to the chapter. The vote was taken and some individuals also made comments while they were voting. See official transcript. View list of TBDWG members present at meeting HERE.
OTHER WG REPORT BUSINESS CONDUCTED:
Chapter 1: Background
Chapter 2: Methods
Chapter 3: Tick Biology, Ecology, and Control
Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics
Chapter 5: Causes, Pathogenesis, and Pathophysiology
Chapter 6: Treatment review Chapter 7: Clinician and Public Education, Patient Access to Care
Chapter 8: Epidemiology and Surveillance
Chapter 9: Federal Inventory
Chapter 10: Public Input review
Chapter 11: Looking Forward
Chapter 12: Conclusion
Review of: Executive Summary
The section on RMSF and Ehrlichiosis states they are managed by antibiotic therapy to prevent patient debilitation, disability and death. No mention of death was made in the Lyme reference; therefore, Pat requested that the word death be included in the section for Lyme disease. Vote to approve Executive Summary with the changes agreed to, passed unanimously. Note: Shapiro left the meeting (as he has done during several past meetings) once again, delegating his proxy vote to Walker.
Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics
Vote to approve chapter 4 passed, with Leigh Ann abstaining. Shapiro was again absent for this vote.
Chapter 6: Treatment
After discussions regarding Powassan Virus references, vote to approve chapter 6 passed unanimously.
Chapter 8: Epidemiology and Surveillance
Vote to approve chapter 8 with the changes discussed, passed unanimously.
Chapter11: Looking Forward
This chapter was previously approved with minor editorial changes however, a minority report will be written by Pat Smith and Captain Scott Cooper, on the strong suggestion in here to include industry in the next WG process– concerns on conflicts of interest and legislative categories which do not include industry.
Chapters 1: Background; 2: Methods; 5: Causes, Pathogenesis, and Pathophysiology; 9: Federal Inventory– Pat requested addition of the link to access the Federal Inventory Questions be inserted in this section, this was approved without contest. All of these chapters were approved previously at the 16th meeting with minor editorial changes.
Chapters 3: Tick Biology, Ecology, and Control; 10: Public Input; and 12: Conclusionwere voted on after minor editorial changes. All passed unanimously.
Appendices: The 21st Century Cures Act delineates categories that WG members must be appointed to. Pat requested that the category of each WG member is to be listed in the report. The WG agreed to add to Appendix A. Report cover and back photos were discussed and decided upon. Smith discussed the need to promote the proper messaging in regard to tick repellent use. The front cover primary image will depict a family outdoors…the real “picture” of how Lyme and other tick-borne diseases are affecting patients across the country.
Verbal public comments were delivered by ten people, many of whom had presented at the previous meeting. Critical care nurse and mother of a child with Lyme, Janice Sutton; Lorraine Johnson, CEO of Lyme disease.org; Dorothy Leland, VP of Lymedisease.org and mother of a child with Lyme disease; Phyllis Mervine, President of Lymedisease.org; Patient advocate, Carl Tuttle; Patient advocate, Lucy Barnes.
View Dorothy Leland’s, Touched by Lyme, blog posts on LDo’s website HERE.
View LDo’s Opinion and Features posts for public commenters HERE.
Public Comments Subcommittee:
Subcommittee Co-chair, Angel Davey, presented tables from the Public Comments Subcommittee, which summarizes incoming written public comments: priority areas/key themes through October 2020. November comments were too numerous to publish publicly prior to the meeting. New comments as well as recurrent themes received in October 2020 included:
“Concern about expedited timing/deadline for call for new public WG members”
“Inquiry as to whether anyone was establishing labeling requirements for mammalian-containing products”
“Obstacles to medical care for LD while living abroad in Australia”
“Reference and supporting information submitted for a new, effective PTLDS treatment protocol”
Horowitz, R.; R. Freeman, P. Efficacy of Double-Dose Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease/Post-Treatment Lyme Disease Syndrome (PTLDS) and Associated Co-infections: A Report of Three Cases and Retrospective Chart Review. Antibiotics 2020, 9, 725.https://doi.org/10.3390/antibiotics9110725
“Reference provided for an in vitro culture study of dapsone combined with antibiotics effectively disrupting Bb biofilms and killing the bacteria”
Horowitz, R.I., Murali, K., Gaur, G. et al. Effect of dapsone alone and in combination with intracellular antibiotics against the biofilm form of B. burgdorferi. BMC Res Notes 13, 455 (2020). https://doi.org/10.1186/s13104-020-05298-6
DISCUSSION OF MINORITY REPORT: The meeting ended with discussion by those who voted against Chapter 7 of how minority reporting will be submitted in response to the large number of dissenting votes in the approval of Chapter 7. There seemed to be ongoing confusion regarding the process and requirement for minority reporting. It was decided that each minority voter for Chapter 7 may submit an individual minority report or there can be a collective report, and the writers will provide input on how to proceed once they have reviewed. View the discussion of minority reporting transcript HERE.
FINAL WG MEETING DATE: The next and final public meeting of the TBDWG for the 2020 report to Congress will take place on December 2nd. Pat requested an HHS presentation of the LymeX partnership, which Jim Berger agreed to provide at that time. Public comments on the meeting must be received by 11:59 p.m., ET, Tuesday, November 24.
LINKS TO OFFICIAL MEETING TRANSCRIPTS:
Registration and public comment instructions may be found on the HHS website HERE.
Click downloaded official written transcript of the complete Chapter 7 discussion HERE.
Watch/Listen to the actual recording of Pat’s Smith rebuttal by clicking below: