Time-sensitive: Act now to make your voice heard at the national level by submitting your comments to the tick-borne disease working group by June 24th
Science shows that chronic Lyme exists. Now it’s time for government agencies to acknowledge it, specifically the CDC.
Make your voice heard to create change at the national level. Please submit your written or verbal comments to the Tick-Borne Disease Working Group by June 24, prior to their next meeting on July 8.
In the last meeting of the TBDWG, the panel argued over whether to update its guidelines on diagnosing and treating Lyme disease. After more than an hour, CDC spokesperson Ben Beard stated, “The vast majority of Lyme disease patients are served quite well by the guidance we have on our website.” This is unacceptable, because:
Lyme disease is a public health crisis. Research shows that two million people could be suffering from post-treatment Lyme disease (PTLD) by the end of 2020. According to a joint study conducted by scientists at Global Lyme Alliance (GLA) and Brown University, more than two million people in the United States could suffer profound disability from PTLD by the year 2020. Noted researcher and former chair of the TBDWG John Aucott, M.D., states that … “These numbers are on par with other important public health threats such as HIV. When combined with the recognized severity of PTLD for patients, the impact is even more significant.”
Science shows that while most patients recover when diagnosed and treated early, up to 20% remain ill.
Science shows that when Lyme is not treated early, due to being undiagnosed, misdiagnosed, inaccurate diagnostic tests, etc – it’s harder to eradicate the disease and the symptoms it brings.
Many physicians follow CDC guidelines on diagnosing and treating illnesses such as Lyme disease, based on the CDC proactively marketing to physicians and the CDC serving as an approved resource for the medical community. Therefore, if the CDC does not acknowledge any stage of Lyme other than acute, neither will physicians. This directly harms patients.
Part of the CDC’s mission states “ … As the nation’s health protection agency, CDC saves lives and protects people from health threats. To accomplish our mission, CDC conducts critical science and provides health information that protects our nation against expensive and dangerous health threats, and responds when these arise.” By denying the existence of post-treatment Lyme, persistent Lyme, and chronic Lyme disease, the CDC is not protecting people from health threats and serving in the best interest of patients and the general community.
Make your voice heard:
Submit Comments (verbal or written) for the next meeting by Wednesday, June 24th to [email protected]. Please click here for further instructions to submit.
Below is text from the letter sent to the Assistant Secretary of Health at the U.S. Department of Health and Human Services regarding changes to the 2019 Tick-Borne Disease Working Group, by GLA Chairman of the Board Robert Kobre
July 1, 2019
ADM Brett Giroir, M.D.
Assistant Secretary of Health
U.S. Department of Health & Human Services
200 Independence Ave, SW – Room 716G
Washington, DC 2021
Dear ADM Giroir:
I am writing on behalf of the Global Lyme Alliance (GLA), where I serve as Chairman. GLA is the largest full service 501c3 organization dedicated to finding effective treatments and reliable diagnostics for Lyme disease. Our rigorous research program has yielded more published studies in peer reviewed journals than any organization focused on Lyme (such as the definition of “Post Treatment Lyme Disease” & the widely accepted belief that 10-20% of patients continue to suffer from Lyme symptomatology after early antibiotic treatment). Further, our strong and open minded scientific approach which is backed by a world class Scientific Advisory Board has spawned many of the most promising areas of Lyme disease etiology, drug discovery and direct and indirect diagnostic pathways.
We want to thank the hard working members of the U.S. Department of Health & Human Services (“HHS”) who helped put together the original 2017 Tick-Borne Disease Working Group (TBDWG) and getting the various parties to work together to drive toward consensus recommendations.
GLA was especially pleased that one key conclusion of the TBDWG reinforced the previous year’s published findings of the GLA sponsored Banbury group (which included over 40 top scientists on both sides of the Lyme debate, and members of the CDC, NIH and FDA) – that the widely used two tier antibody test lacked the necessary sensitivity to be a useful tool for diagnosis and more current direct and indirect approaches were urgently needed. Without being able to identify who has Lyme disease and who does not, the debate about Post Treatment Lyme Disease and Chronic Lyme disease will continue.
We also wanted to voice a few concerns about the current 2019 version of the TBDWG. GLA was hoping that the newly constituted TBDWG would build upon the scientific road map and Lyme disease recommendations of the 2017 effort, which in turn would drive additional federal funding for Lyme disease research. Apparently the direction of the group has turned to Rickettsia, while also worthy of study, does not have the incidence rates associated with Lyme disease in the United States. To the extent the 2019 TBDWG focuses on Lyme disease, GLA would ask that the HHS and TBDWG leadership present a diverse set of views on long-term Lyme disease through the use of researchers and patient advocates at the committee and sub-committee levels. If that is not possible, our strong recommendation would be to drop the Lyme arm of the 2019 efforts because having only one researcher who believes Lyme disease is a simple bacterial form and easy to treat, without having a balance of scientific experience on the committees, will undoubtedly lead to conclusions that are inconsistent with the findings of the previous TBDWG and can harm the advancement of Borrelia burgdorferi research. GLA’s DNA is disciplined scientific research. Over a decade of receiving grant proposals makes us acutely aware of the diversity of thought and proven science around this fast spreading, devastating disease and therefore having a single viewpoint on the TBDWG is both dangerous and short sighted.
GLA supports the efforts of other Lyme organizations, such as LymeDisease.org, who have voiced their concerns about the selection process, members, transparency, testimonial access, gender inequality and focus of the new committee. GLA understands that the composition of the TBDWG and its committee structure is not transparent by regulatory design, with mandatory short notice given to participants. However, we strongly encourage the leadership at HHS and TBDWG to improve transparency on selection and make the necessary adjustments to move us forward on the Lyme learning curve. With 425,000 new cases per year and over 2 million PTLDS patients and more who never received early antibiotic treatment who are suffering medically, emotionally and economically, we assume that you, like we, want to help accurately diagnose patients and cure those with acute and long-term Lyme disease as quickly as possible.
Thank you for your time and consideration.
Global Lyme Alliance
Robert Herriman with Outbreak News interviews GLA’s Chief Scientific Officer Timothy Sellati, Ph.D. to discuss Lyme disease, the Tick-borne Disease Working Group, and the IDSA
Read the complete transcript below or listen to the podcast:
Robert Herriman: Well hey everybody, this is Robert, and welcome to Outbreak News Interviews. Now the Federal Tick-Borne Disease Working Group recently released their first report to Congress about one year after the panel first convened. The Infectious Disease Society of America, or the IDSA, responded to the report in a letter that contained some criticisms of the report. So what is the Federal Tick-Borne Disease Working Group, what’s in the report, and what did the IDSA have to say? Well joining me to discuss these issues is Chief Scientific Officer for the Global Lyme Alliance, Timothy Sellati, Ph.D. Dr. Sellati, welcome to the show, sir.
Timothy Sellati: Thank you for having me.
Robert Herriman: You bet. So Dr. Sellati, let’s go ahead and start out with some basics ’cause some people may not be aware of this. What is the Federal Tick-Borne Disease Working Group, what’s their mission, and what’s the personnel composition of this group?
Timothy Sellati: So the Working Group was established as part of the Congress’s passage of the 21st Centuries Act, back in December 2016. The intent of that Act was to promote new healthcare initiatives for addressing array of public health issues, and one in particular was the advancement of research on tick-borne diseases. So with that as a backdrop, the US Department of Health and Human Services established the Federal Advisory Committee, the Tick-Borne Disease Working Group. So the Working Group is comprised of 14 voting members, there were seven public members and seven Federal members, and the composition of the Working Group was really drawn from a diverse group of professions. We had individuals that are world renounced research scientists, and physicians from top tier academic institutions and hospitals, subject matter experts from government agencies, as well as key stakeholders from the public sector including patients, and their advocates from several Lyme and other tick-borne disease nonprofit organizations.
Robert Herriman: Okay. So they recently released their first report, it’s a pretty hefty 108-page document. Dr. Sellati, what did you find good and important in the report?
Timothy Sellati: So I think some of the most important or key recommendations out of the report really related to epidemiology, and ecology, that was one of the subcommittees of the Working Group. And there, it was really driven home, the idea that Lyme disease surveillance criteria, which is a criteria that the CDC the Centers for Disease Control and Prevention, use for calculating the number of Lyme disease cases that occur annually. Those really should be used for surveillance purposes alone, and not for diagnostic purposes. The other important take home message from the prevention subcommittee was a focus on development of anti tick feeding vaccines, and really trying to work with key stakeholders to build trust via transparent mechanism to help examine and discuss the past Lyme disease vaccine activities, what some of the issues were with it, and the potential for adverse events so that that information coming from a number of different sources could help inform future vaccine development in Lyme disease. In terms of diagnosis, the real take home message was the importance of evaluating new technologies or approaches for the diagnosis of Lyme disease and other tick-borne diseases because of the inherent limitations with the current two-tier testing method. And the importance of including children in the process of diagnostic test validation as well, because children are particularly prone to the devastating consequences of dealing with Lyme disease, or other tick-borne diseases.
Timothy Sellati: In terms of treatment, I think conduct of additional clinical trials using appropriate target populations where gaps may exist. And there really, the glaring gap is with respect to patients, that experience, persistent symptoms and disability and diminished quality of life following the current standard of care, which is 10 to 28 days of antibiotics. So it’s really important to understand, this really came through as the overall gestalt of the report, that Lyme disease can be treated with antibiotics, but as many as 10% to 20% of infected individuals do not respond favorably to those antibiotics, so they go on to develop what we call Post Treatment Lyme Disease Syndrome, or in some circles, chronic Lyme disease. And so it’s really important to really address that gap in our understanding of how best to treat that patient population.
Timothy Sellati: And then the one last thing, and this was really a common theme that came out of all of the subcommittees’ reports, was the need to allocate increased funding for tick-borne diseases in the areas of research, treatment, and prevention, and have it really pegged to the burden of illness. So proportionally, there is much less federal funding to tackle tick-borne diseases than there are funding for other infectious diseases where the number of cases per year are considerably smaller.
Robert Herriman: Yeah. Now, were you 100% on board with everything in the report, or were there any issues that you had a problem with?
Timothy Sellati: I didn’t have any issues per se, with the report, as much as a concern about one of the recommendations. And this related to the protection of the rights of license and qualified clinicians to use individual clinical judgment to diagnose and treat patients in accordance with the needs and goals of each individual patient. I’m sort of reading that, verbatim almost, and while I don’t have any concerns about allowing licensed and qualified clinicians to care for their patients as they see fit, I also recognize that as a result of desperation on the part of some patients that have dealt with Lyme and other tick-borne diseases for years, if not decades, they are driven to seek out medical care from clinicians using treatment options that have not been carefully vetted by the scientific research establishment, or the medical research establishment. And so there’s a concern that there are some treatment options out there that really have not been proven to effectively treat the symptoms or the diseases that these desperate patients are dealing with.
Robert Herriman: Not too long after the release of the Working Group’s report, the IDSA sent a letter to DHHS Secretary Alex Azar, and it contained some criticisms of the report. You responded to the letter in a post on the Global Lyme Alliance website. Can you spend some time talking about that?
Timothy Sellati: Sure.
Some of the criticisms leveled by the IDSA that really caught my attention was that they had significant concerns with the Working Group’s lack of transparency, and minimal opportunities for meaningful public input. And I just didn’t understand the basis for that criticism, given that the Working Group was really comprised of so many different subject matter experts, and physicians that are treating patients, and the patients themselves, that I think the greater concern on the part of IDSA is that perhaps they didn’t have as much input into the report, or the content of the report, that came out of the Working Group’s extensive efforts.
Timothy Sellati: The IDSA also suggested that some of the recommendations of the working group would “cause significant harm to patients in public health,” and they really urged Alex Azar to ensure that the Federal government response to tick-borne disease’s fallacy rooted in the best available scientific evidence. And you know, part of the problem is in the controversy surrounding Lyme disease, is that the IDSA takes a strict parochial approach to considering Lyme disease, and the consequences of infection with bacteria that causes Lyme disease. From their perspective, they think Lyme disease, or promulgates this idea that Lyme disease is easily treated, and it’s easily diagnosed, and only very rarely does it result in lasting consequences of infection. But there is more and more well established scientific evidence in the main stream literature that argues against that very narrow understanding or narrative that IDSA wants to push forward.
Robert Herriman: Now, going to your first point, on the Working Group, is there any former or current IDSA members on that Working Group? I mean, do you know that?
Timothy Sellati: Yes, I believe there are.
Robert Herriman: Okay.
Timothy Sellati: I believe there are. But on the flip side, there are also, from what I understand, members of the ILADS organization as well. The composition of the subcommittees also was careful to include research scientists and physicians that really span the spectrum from IDSA on one of the end of the spectrum, to ILADS on the other. So I really do think that within the limited, within the capabilities of the Working Group, they were as intent as possible, in terms of hearing the voices of a wide variety of individuals. And again, to some extent, maybe IDSA would like to have had a larger bullhorn in terms of influencing the Working Group’s final report to the Congress.
Robert Herriman: So I just take it from your previous answer, that you don’t think most of the IDSA criticisms really hold a lot of water?
Timothy Sellati: No. No, I really don’t. And that’s what really spurred me to write this rebuttal in the first place. Again, I believe many of IDSA’s criticisms stem from the fact that the overall content of the report doesn’t necessarily fit into their mantra that Lyme disease is easy to diagnose, it’s easy to treat, and only very rarely results in lasting consequences of infection. So when you come into trying to solve a problem with that mindset, it limits how you approach trying to solve that problem.
Robert Herriman: Okay. Well, for the audience if you haven’t seen any of this, I will put up a link to Dr. Sellati’s rebuttal on the website when I publish the podcast, and I’ll also put up a link to the IDSA letter, and you can read it, and you can judge for yourselves. Dr. Sellati, any final thoughts on any of these issues?
Timothy Sellati: Yes, I’m glad you asked. So there is one final thought. As far as the report is concerned, I think there was a very important section in the report titled, “Looking Forward,” and in my opinion, I think one of the most important take home messages from that section was the need to develop and disseminate more comprehensive clinical education that highlights the diversity of symptoms that Lyme and other tick-borne disease patients might present with, expand the geography of infecting tics, and also the limitations of the current testing procedures. So I think if we do a better job of communicating to clinicians, and maybe even at the level of medical school students, the complexity of Lyme disease, and what some of the true limitations are in terms of prevention, diagnosis, and treatment, they will be better prepared to take care of the diversity of patients that they see during their practice.
Robert Herriman: Well very good. Well, I wanted to thank you Dr. Timothy Sellati for joining me to discuss these very important issues, I appreciate it, sir.
GLA’s Chief Scientific Officer Provides Evidence-based Rebuttal of IDSA Letter to Head of HHS and Tick-Borne Disease Working Group Report
by Timothy J. Sellati, Chief Scientific Officer, Global Lyme Alliance
Last month, the Tick-Borne Disease Working Group (TBDWG) published its first report to the U.S. Congress, outlining an integrated, multi-pronged approach to the growing public health challenges posed by tick-borne diseases in the U.S. In response shortly thereafter, the Infectious Diseases Society of America (IDSA) sent a letter to to the Secretary of the U.S. Department of Health and Human Services (HHS) stating that if some key recommendations of the TBDWG are implemented, it “would cause significant harm to patients and public health.”
Below is a rebuttal to IDSA’s unfounded criticisms of the TBDWG, which we find hyperbolic in light of the hundreds of man hours worked on the part of dozens of stakeholders dedicated to collecting, collating, and drafting a roadmap to advance the prevention, diagnosis, and treatment of patients suffering from Lyme and other tick-borne diseases.
IDSA’s letter suggests that there are “significant concerns with the working group’s lack of transparency and minimal opportunities for meaningful public input.”
The basis for this concern is unclear given that a substantial effort was made to be inclusive of professionals within the academic research community, physicians at renowned academic institutions and in private practice, as well as members of the general public in the form of patients suffering from Lyme and other tick-borne diseases and their advocates. Through contacts with their colleagues and fellow patients sitting on the TBDWG a free flow of ideas and opinions has passed between various stakeholders not part of the working group as well as those on it. The more likely concern of the IDSA is that it could not control the working group’s deliberations and final report through which it means to ensure consistency with the society’s long-held, and some would argue entrenched, ideas about tick-borne disease. Paramount is IDSA’s long-held view that Lyme disease is easy to diagnose, easy to treat, and only very rarely results in lasting consequences of infection. On the contrary, the overwhelming consensus among tick-borne disease researchers is that Post Treatment Lyme disease Syndrome occurs in 10 to 20% of those who received early treatment.
IDSA’s letter also suggests that if implemented, some recommendations of the TBDWG “would cause significant harm to patients and public health.”
Besides IDSA’s having only very limited support in the peer-reviewed scientific and medical literature regarding unsafe alternative treatment options, this hyperbole seems intended to spread fear, especially when one takes into consideration tick-borne disease researchers’ ever-evolving clinical understanding of Lyme disease, as opposed to the IDSA’s obsolete mantra that Lyme is easy to diagnose, easy to treat and only rarely results in lasting consequences of infection.
”We urge you to ensure that the federal government response to tick-borne diseases is solidly rooted in the best available scientific evidence.”
Any claim that the TBDWG is not solidly rooted in the best available scientific evidence is unfounded. TheTBDWG report draws from the efforts of subject-matter experts from such diverse organizations as Johns Hopkins University School of Medicine; Office of the Secretary, U.S. Department of HHS;Stanford University Lyme Disease Working Group; Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention (CDC); Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases (NIAID); Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of HHS; Population Health Sciences and Health Services Research Center of the Institutional Centers for Clinical and Translational Research, Boston Children’s Hospital; Vector-Borne Disease Laboratory; and Maine Medical Center Research Institute, just to name a few.
IDSA suggests that the makeup of the TBDWG is “skewed to individuals with perspectives that do not align with the overwhelming majority of scientific evidence regarding the diagnosis and treatment of Lyme disease.”
Evidently, one organization’s definition of “skewed” is another group’s diverse voices, opinions, and peer-reviewed evidence. Ultimately it does not benefit the scientific and medical research enterprise nor the Lyme and other tick-borne disease patient community to hew to the notion IDSA promulgates, which is that “Lyme disease is easy to diagnose, easy to treat, and only very rarely results in lasting consequences of infection”. Moreover, one could effectively argue that at least a subset of IDSA members hold perspectives about the persistence of Lyme borreliosis despite initial antibiotic treatment and see the desperate need for alternative treatment strategies that “do not align” with current scientific evidence.
While IDSA acknowledges that the CDC case definition for Lyme disease is intended for use as an epidemiological tool, they suggest “it is it is incorrect to promulgate the notion that the components of the surveillance definition should not be used for clinical diagnosis”.
However, it is important to note as the CDC itself mentions throughout its webpage that the case definition provided is for purposes of surveillance. Nowhere is it mentioned that the case definition criteria listed should be used for clinical diagnostic purposes alone. The CDC goes on to state that “Surveillance case definitions establish uniform criteria for disease reporting and should not be used as the sole criteria for establishing clinical diagnoses, determining the standard of care necessary for a particular patient, setting guidelines for quality assurance, or providing standards for reimbursement.” Finally, the spurious nature of IDSA’s suggestion that components of the surveillance definition could or should be used for clinical diagnosis is evident in the fact that CDC research has confirmed that annual clinical case numbers for Lyme disease are approximately 10-fold higher than the number reported by the CDC. This upward revision of annual Lyme disease cases suggests that considerably more early Lyme diagnoses are being missed than are the result of inaccurate, ultimately non-Lyme, diagnoses being made.
IDSA acknowledges that “some patients who are successfully treated for Lyme disease continue to suffer from persistent symptoms after treatment”.
This statement is illogical, however, because a patient who continues to suffer from symptoms caused by infection cannot or should not be classified as successfully treated.
IDSA states that “There is clear, widely accepted scientific evidence indicating that a 10-28-day course of antibiotics, depending on the stage of Lyme disease, will kill the Lyme disease bacterium in humans in all but the rarest of cases”.
Unfortunately, IDSA refuses to acknowledge that there also is clear, widely accepted and compelling scientific evidence indicating that 10 to 20% of patients receiving a 10-28-day course of antibiotics progress to Post-Treatment Lyme Disease Syndrome, which has a clear clinical definition, or the more broadly clinically-defined state of chronic Lyme disease. If one considers the number of CDC-reportable cases for 2016 of 364,290 (based on surveillance case reporting to CDC multiplied by a 10-fold factor to account for estimated underreporting) then 36,429 to 72,858 patients annually progressing to PTLDS/chronic Lyme disease cannot reasonably be considered a rarity.
IDSA supports more research to improve diagnostic tools for Lyme disease and they correctly state that it is essential that clinical education is rooted in the best currently available evidence.
Yet it is unclear that medical school educators are explaining to students that the best currently available evidence suggests that a large percentage of patients suffer persistent symptomatology as a result of misdiagnosis of early Lyme disease due to deficiencies in the current two-tier test. It is also unknown whether students are instructed in the atypical size, shape and coloration of the erythema migrans (EM) rash, rather than the classic “bull’s-eye” rash, that can be observed in some, but not all Lyme patients. In fact, despite IDSA’s claims, according to the CDC only 70 to 80% of patients with Lyme disease reported to its surveillance system the presence of an EM rash.
IDSA supports increased federal funding for responses to tick-borne diseases and correctly notes that higher level funding should not come at the expense of funding for other diseases, including HIV. The IDSA letter goes on to state that “Pitting one disease against another, as suggested in the draft report, is counterproductive and costly.”
While everyone can agree with the former statement, the latter is a mischaracterization of the content and intention of the TBDWG report. Suggesting that the level of funding for Lyme and other tick-borne diseases should be commensurate with the case incidence rates is not pitting one infectious disease against another; it is, rather, a fair-minded plea for equitable distribution of limited funds based on current public infection risk. Making comparisons between Lyme disease and HIV merely highlights the disproportionate distribution of funding if one looks solely at case incidence rates for the two diseases.