Government Refuses to Address Geographic Boundary Restriction Preventing Lyme Diagnosis
How this happened on the Working Group The Access to Care Subcommittee unanimously recommended the Potential Action below.
Working Group Access to Care Subcommittee Report Potential Action 4: Recommend that CDC provide input to the Council of State and Territorial Epidemiologists, CSTE, that the Lyme disease surveillance case definition be revised such that it abandons the use of geographic parameters for Lyme disease.
The above potential action was altered and removed from Access Chapter to the Surveillance Chapter without any sustainable reason given by the WG agencies for not supporting it. The below change was accepted and voted on by the WG. Pat Smith voted no to the change.
Tick-Borne Disease Working Group 2020 Report to Congress Chapter 8 Recommendation: Recommend that CDC work with Council of State and Territorial Epidemiologists, CSTE, to streamline the surveillance process and reduce the burden on clinicians and public health departments by permitting direct laboratory reporting of positive cases.
How Pat Smith Countered the action By virtue of voting no, Pat Smith was able to insert a Minority Response. She developed the following minority response, which can be found in the Tick-Borne Disease Working Group 2020 Report to Congress, pp.91, 92
Minority Response: Effect of Geographic Restrictions on Lyme Diagnosis Access to care, as defined by the National Academy of Medicine, is “the timely use of medical care to obtain the best possible outcome.” With regard to Lyme disease, the Training, Education, Access to Care, and Reimbursement Subcommittee was concerned that additional geographic restrictions added to the surveillance case definition in 2017, have lulled clinicians in “low-incidence” states into mistakenly discounting a potential Lyme disease diagnosis. The resultant diagnostic and therapeutic delays that patients in those states have already reported have subsequently limited their ability to obtain their best possible outcome. To reduce this diagnostic hurdle, the subcommittee recommended that “CDC provide input to the Council of State and Territorial Epidemiologists, CSTE, that the Lyme disease surveillance case definition be revised such that it abandons the use of geographic parameters for Lyme disease” and that “CDC, NIH, and other government agency websites, brochures, and educational materials abandon the use of geographic parameters for the diagnosis of Lyme disease and inform clinicians and the public that Lyme disease has been reported in all states” (Training, Education, Access to Care, and Reimbursement Subcommittee, 2020). This Minority Report specifies why the geographic proviso should not have been removed from the Working Group report as a recommendation to Congress.
In moving to a state-based designation, the surveillance case definition has misled clinicians regarding the risk of Lyme disease in their area. Lyme disease exposure is largely driven by geographical terrain and climatic factors. Because these elements vary within a state, state-based incidence definitions obscure the risk for patients exposed in localized “hot spots.” As detailed in the subcommittee’s report, outside data sources Quest and Fair Health, the latter with a database of 23 billion healthcare insurance claims, show that CDC statistics on low-incidence states are inaccurate (Lee-Lewandrowski, Chen, Branda, Baron, & Kaurman, 2019; McGinty, 2018). Additionally, instituting more stringent requirements for what constitutes a confirmed erythema migrans case in low-incidence states results in undercounting of cases and sets up a self-perpetuating cycle for a low-incidence designation as doctors there often are not diagnosing and treating. They are frequently concerned about the ramifications from medical boards who have sanctioned physicians in some circumstances.
Additionally, when clinicians underestimate their patients’ risk of Lyme disease, they may mistakenly discount true cases of the infection and lengthen the time to diagnosis and treatment. Patients misdiagnosed because of geographically-based misconceptions often have to travel to distant states for a willing and knowledgeable clinician and are likely to experience treatment delay, which increases their risk of developing persistent Lyme disease. As noted in the subcommittee’s report, a survey of patients with persistent Lyme disease documented that 70% reported substantial diagnostic delays (Johnson, Shapiro, & Mankoff, 2018). Diagnostic delays can be costly; the total averaged cost of treating late Lyme disease is approximately $24,000 per year, which is 12 times higher than the cost of treating early Lyme disease (Johnson, 2019; Zhang et al., 2006). The report also details the substantial 92 consequences that persistent Lyme disease has on patients’ lives: 72% of patients with chronic Lyme disease reported their health status as fair or poor and 75% experienced severe or very severe symptoms; many are unable to regularly attend school or hold down a job (Johnson, Wilcox, Mankoff, & Stricker, 2014).
Given the negative impacts on access to care for Lyme disease that geographic parameters in the surveillance case definition impose on clinicians and patients, the subcommittee’s initial recommendation on CDC recommending review of the geographic diagnostic restrictions should have remained intact. Patricia V. Smith, BA
References Johnson, L. (2019, August 23). MyLymeData 2019 Chart Book. Retrieved from https://doi.org/10.6084/ m9.figshare.8063039.v1 Johnson, L., Shapiro, M., & Mankoff, J. (2018). Removing the Mask of Average Treatment Effects in Chronic Lyme Disease Research Using Big Data and Subgroup Analysis. Healthcare (Basel) 6. doi:10.3390/healthcare6040124 Johnson L., Wilcox S., Mankoff J., & Stricker R. B. (2014). Severity of chronic Lyme disease compared to other chronic conditions: a quality of life survey. PeerJ, 2. doi: 10.7717/peerj. Lee-Lewandrowski, E., Chen, Z., Branda, J., Baron, J., & Kaufman, H. W. (2019). Laboratory BloodBased Testing for Lyme Disease at a National Reference Laboratory: A 7-Year Experience (2010-2016). American Journal of Clinicalal Pathology, 152(1), 91-6. doi:10.1093/ajcp/aqz030 McGinty, J. C. (2018, June 22). Lyme Disease: An Even Bigger Threat Than You Think. The Wall Street Journal. Retrieved from https://www.wsj.com/articles/lyme-disease-an-even-bigger-threat-than-youthink-1529672401 Training, Education, Access to Care, and Reimbursement Subcommittee. (2020). Report to the Tick-Borne Disease Working Group. Retrieved from https://www.hhs.gov/ash/advisory-committees/ tickbornedisease/reports/training-education-access-to-care-and-reimbursement-subcomm-2020/index. html Zhang, X., Meltzer, M. I., Peña, C. A., Hopkins, A. B., Wroth, L., & Fix, A. D. (2006). Economic Impact of Lyme Disease. Emerging Infectious Diseases, 12(4), 653–660. doi: 10.3201/eid1204.050602
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.
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:
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:
TBDWG 16 – Fight Continues for Patient Relief: Get Patients Diagnosed & Chronic/Persistent Lyme Recognized
The 16th meeting of the Federal Tick-Borne Disease Working Group (WG) took place 10.27.20. Public commenters urged the WG to acknowledge and act on the changes needed for patient relief. In review of report chapters, contentious arguments continued, with Pat Smith again advocating passionately on behalf of chronic Lyme patients. (Below items are not in agenda order; quotes are from recorded transcript).
Smith in WG meeting on geographic boundaries preventing Lyme diagnosis: “I lived in the world of patients for 36 years, and I can tell you that they are not getting treated in those states [low incidence states] because the government and other entities are telling them there is no disease. They are consistently not being diagnosed and treated, and you think this because there is a positive test they will get treated? No way. That doesn’t happen. To do this is the kiss of death. You will put another nail into the coffin of people in these states and to do this without even being willing to make changes to the language, I find it totally unconscionable.”
Chapter 8: Epidemiology and Surveillance Review (2.5 Hours of Contentious Discussion of Diagnostic Testing)
Pat Smith stated “Since Lyme disease has the burden of illness within TBD and testing is one of the biggest issues, why is that not discussed in this report?” Emphatically explaining position: “We have a whole section on major challenges and issues and I didn’t see Lyme disease mentioned as far as diagnostics, and it’s unbelievable to me that after 46 years, and after the time since 1994 at Dearborn when the test were developed, that we consistently say the tests are appropriate, and I think something is to be put in that section about Lyme disease.” After further discussion Smith reiterates, “I think it [Lyme] definitely needs to be entered in, and the huge significance that it holds for Lyme patients, it is one of the major reasons that they are not getting diagnosed and they are not getting treatment.” David Walker responded, “Lyme disease moves more slowly and there is ample opportunity and a much better opportunity to make diagnosis.” Pat retorted, “David, you don’t think there’s any Lyme disease beyond a few weeks and a few Doxy pills, and I think the time has come that we have to acknowledge there is ample research out there to show it isn’t true, and that diagnostic tests are not picking up our patients, and it’s time we did something about it! I don’t know what we are waiting for. And I’m not asking for the moon in this chapter but asking merely for something that addresses the fact that there is a need and obviously the government has to look at that need.” Walker responded, “I’m aware that Lyme disease can lead to death. Cardiac arrhythmia…that can happen. But Post Treatment Lyme Syndrome pathogenesis is unsettled.” After further discussion, there was WG agreement to make changes to include Lyme.
Surveillance: Captain Scott Cooper provided a comment regarding Bayes Theorem and “prior probability that the patient has Lyme disease.” His comment, “All of Bayes Theorem depends on prior knowledge and assumptions, when there is not sufficient information to form these assumptions, the premise that Bayes Theorem is helpful is incorrect. Instead the important thing is to develop the underlying knowledge base. This is why the CDC conducted 3 studies that increases its estimate of Lyme disease from 30,000 to 300,000 cases. Likewise we need to look at all available data (laboratory tests, insurance claims, etc.) to determine ground truth about prevalence and incidence in an area before we ‘assume’ we know the distribution of the disease. This is a circular argument. The assumption that pre-test probabilities are accurate depends on whether the Bayes theorem analysis is correct. As pointed out above, the accuracy of Bayes Theorem here is flawed because we do not know the ground truth about the incidence of Lyme.” When asked to explain comments, he responded, “So I was saying it needs to be clarified, that I wasn’t buying the base there and that analysis.” Ben Beard, “You disagree with the prospect of how pretest likelihood predictive values fit into this? Or do you think that in states, the bar is fairly low for establishing Lyme disease to be, in states like Colorado? If it were common you would at a minimum see a lot of EM rash with tick bites. That constitutes probably 80% of the reported Lyme disease cases.”
Discussion continued with topic of travel related reporting, with Smith using Florida as an example of endemic Lyme disease, but for years, reported cases were often deemed travel related but the State of FL had checked out those cases and many were not travel related. Ben Beard, “I think I understand what Coop and Pat are requesting is an open door to emphasize things that pretest likelihood and probability is important and a limitation, and that we are still learning the area of risk, and it’s changing and acknowledging that.” Walker had made a motion to retain the paragraph as originally written. Smith again contested Beard’s comments, “I would like to say first of all that it’s bothersome to me and then you touched on this, that the area of risk is changing, and that is exactly what I think we are talking about. First of all, the surveillance that is done in a lot of the states that are considered ‘low incidence’ is not good. They hardly have any surveillance. You may be funding them now but they have not been traditionally funded to do tick surveillance and often times when they do surveillance, they do show up that they are — there are other types and perhaps those ticks may be transmitting and nobody is really looking at that issue because I don’t think anyone wants to look at that issue.” (Pat was referring to other proven competent tick vectors for the Lyme disease bacterium, like Ixodes spinipalpis and Ixodes angustus, known to be endemic in many deemed ‘low incidence’ states in which little or no tick surveillance is occurring). Surveillance definition, and the problem of positive results automatically being deemed as false positives because they are originating from states that are deemed “low incidence” is an issue that Smith continued to fight as she explained, “That is going to cause patient death…. That is what diagnostic is with Lyme disease, it IS surveillance definition, therefore in the states already considered low, so that they already cannot get diagnosed and treated, and now you are further emphasizing to their position.” Walker responded, “Of course they can be treated. Signs and symptoms of Lyme disease and confirmed with laboratory tests but everyone would treat this.” Smith responded to Walker, “I lived in the world of patients for 36 years and I can tell you that they are not getting treated in those states because the government and other entities are telling them there is no disease. They are consistently not being diagnosed and treated, and you think this because there is a positive test they will get treated? No way. That doesn’t happen.To do this is the kiss of death. You will put another nail into the coffin of people in these states and to do this without even being willing to make changes to the language, I find it totally unconscionable.” She held strong in defense of patients, “David, you don’t know what goes on with Lyme disease in patients and you don’t know the difficulty.” The motion was again brought forward to retain the original language in the paragraph, the motion failed, Smith prevailed. Suggestions for additions & changes continued. The WG group will review revisions next meeting.
“Streamlining” CDC Reporting: Ben explained “The problem we are having is that reporting changes constantly and the way it is right now it is unsustainable…As it is now you’ve got states, some states that are following it and some states that are not, because it is too burdensome and it changes every few years. It is comparing apples to oranges. What we want to accomplish for surveillance is to have a system where it stays the same so we can really understand burden in print and how it is changing and what is going on.” Pat Smith: “As you know, this is certainly something that we advocates have been looking for a very long time.” The WG agreed to the verbiage of a “standardized” rather than a “streamlined” reporting system.
Citations: Although lack of citations sometimes happens, extended discussions occurred when Pat Smith requested that more current and relevant resources be used to cite the percentages used in the paragraph citing untreated Rocky Mountain Spotted Fever (RMSF) fatality rates. Pat specifically requested that references more current than the published review of a 1904 reference provided by Walker be inserted to represent the current, rather than historical fatality rate, especially because the 1904 information is not even accessible. Pat expressed “Our citations are supposed to be ones that someone can find and look up and that is substantiating what we put there.” Walker argued, that in 1941 [another reference used by Walker], preceding the use of antibiotics, the case fatality rate was 74%. Pat responded, “It would be interesting and appropriate if it was a discussion of the history of research and the fatality rates. But that is not what we’re looking for. We’re looking for current fatality rates.” Walker defended that untreated fatality percentage numbers are still relevant by saying “The organism hasn’t changed, and people have not changed.” Pat contended that “people back then did not have the same amenities, and so on to survive that we have here in our country today.” The exhaustive discussion described historical percentages as well as percentages for different parts of the world where this disease occurs, (Pat cited a CDC study addressing a possible more virulent strain in Brazil that has a higher fatality rate but says US rates lower) and clarified that the issue is not that RMSF is not a serious disease that can result in mortality if left untreated. The issue is that the resources cited are extremely dated and inaccessible. Pat reiterated “We need current data, not old data.” The WG agreed to revise with a more current citation provided by Ben Beard.
Minority Reporting (Discussion to get Smith motion passed to prevent removal took 1 hour): This chapter contains the minority report, which was written by Pat Smith and submitted in April after a “no” vote, addressing “Effect of Geographic Restrictions on Lyme Diagnosis. It specifies why the “diagnosis by geography” proviso should not have been removed from the WG report as a recommendation to Congress. The original recommendation which was in the patient access chapter was CDC provide input to the Council of State & Territorial Epidemiologists, CSTE, that the Lyme disease surveillance case definition be revised such that it abandons the use of geographic parameters for the diagnosis of Lyme disease and inform clinicians and the public that Lyme disease has been reported in all states.
Because changes over the past two weeks in WG minority report process appeared to have occurred between meetings through a string of emails, Smith wanted to insure that her minority report remained in place, so she moved that her “..minority report shall remain in Chapter 8 where it was placed after she followed the working group procedures then in place, she having voted no to the recommendation the minority report addresses at a public working group meeting, and having submitted the minority report for Chapter placement on April 17, 2020.The minority report was placed where it has remained in Chapter 8 for all WG members to see after placement and discussion of many iterations of the Chapter. There is no requirement for her to vote against the Chapter for it to remain there, as she has voted no to the recommendation.”
Lengthy and confusing discussion ensued following the motion regarding the process and requirement for minority reporting. Smith stated, “I do not agree that we should have minority reports if you don’t vote no on some aspect.” Smith further stated, “A consensus process means you go in with the idea that you are going to work to a common goal and hopefully gets to where everybody agrees.” The WG works through a consensus process. Smith stated, “we had these values in place which is all about collaboration where we are trying to put forward the best report.” Further Smith explains, “if a person does not have to accept responsibility, they are not on the floor making a vote and expressing their dissatisfaction by voting no for a certain segment, the accountability is tremendously diminished.” She goes on to say “We are allowing somebody to go off and give a proxy vote to somebody else. In my opinion that abrogates the entire process that we go through sitting at a table and having our discussions.” The discussion continued until Jim Berger interceded, “This is the response that I got from legal counsel in regard to the minority responses. They stated, minority responses are included in the report when members of the working group disagree with the recommendation or agrees with the recommendation, but disagrees with the verbiage that the members add to provide their support. If there was total agreement to the verbiage that was added to the chapter supporting the recommendation, then there will be no need for minority response.” Ben asked, “How do you know there is a minority if there is no vote?” After even more discussion regarding whether a vote is required or not in order to write a minority report, Smith moved the WG vote on her original motion for the 3rd time, and the vote passed unanimously. To resolve the total issue of minority reporting Smith stated, “I would like to make a motion at this time, that in order for the minority report, a person has to vote no against either the report or some portion of the report.” The motion was further clarified to state “the report chapter or some portion of that chapter,” and the vote again passed unanimously, putting this issue to rest.
Shapiro pushes back: Shapiro had left the meeting during the discussion of minority reporting and upon his return to the meeting, he was extremely disgruntled when he realized that the group had passed a motion requiring that one must vote in the minority on a chapter report or some portion of the chapter report in order to write a minority report. He was reminded that he had left his vote with Walker during his absence from the meeting discussion…and Walker had voted yes on the motion for both of them. Because Shapiro had asked Walker to cast his proxy vote in his absence, he voted ‘yes” to the motion.
After lunch, Chapter 11: Looking Forward, Chapters 1: Background, Chapter 2: Methods, and the Table of Contents and Title Page were all reviewed and motions to accept the chapters passed. In the Looking Forward chapter, however, language suggesting that the next working group perform outreach to other stakeholders, including industry, was challenged by Pat Smith who said it needed to be restricted to preclude industry being put on the WG. The two co-chairs argued the point, but Pat Smith indicated the legislation creating the WG does not include industry category, which Jim Berger concurred with when asked. Industry could be on subcommittee or as a speaker. Co-Chair Soltysiak did not want to put on restrictors. A motion was made to keep language as is, which passed with a no vote by Smith and Cooper. The concerns expressed were conflicts of interest from industry, and changing the intended nature of the WG. Smith and Cooper also voted no to the Chapter itself.
Chapter 3: Tick Biology, Ecology, and Control Review
This chapter review and discussion was uneventful with request for added citations for data sources and maps.
Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostic Review
Again, Walker and Shapiro expressed issue with Donta’s paragraph that describes the lack of IGG and IGM antibody response in patients with Lyme disease. Walker stated in the comments that “this paragraph contains opinions that are not sufficiently evidence based.” After much discussion, revisions were made to this paragraph to state that “In the absence of being able to prove that there was persisting infection in patients it’s not possible to say a patient did or did not have (Lyme disease).” Additional citation changes were again requested by Smith as she has repeated throughout the review of chapters. She stated, “it’s amazing to me…for one disease we have to document 50 times over and for others we don’t have to provide citations.” Ben agreed to locate some of the references requested. A vote to accept this chapter was postponed until next meeting. Entering into Chapter 5, many WG members announced that they would have to leave the meeting before completing review of all chapters on the agenda.
Chapter 5: Causes, Pathogenesis and Pathophysiology Review
Review of this Chapter was uneventful, with only a few suggestions from Smith for reference citations to be added regarding Alpha-gal Syndrome and NIH. A motion to accept this chapter passed unanimously.
Chapter 6: Treatment Review
Walker asked that Donta make changes to the paragraph that discusses the success of long-term antibiotic trials between patients receiving long-term antibiotics versus placebo. Walker’s intent was to highlight that long-term antibiotics used in the studies did not show any better symptom resolution then patient’s receiving the placebo. Donta agreed to revise the paragraph. Pat again requested additional references to support the content of this chapter. A decision to hold on voting until Donta reviews the chapter.
Chapter 7: Clinician and Public Education, Patient Access to Care Review
At this point in the day, WG members questioned whether there was time to get through this chapter, or to postpone until the next meeting. Smith responded that “our chapter only has like 3 comments, or maybe 4, and some of those are reference comments I believe, so hopefully it’s going to be quick.” Shapiro then announced, “I have a minority report for this chapter which is why I did not make comments.” Sam Donta suggested that perhaps the WG should postpone so that they could work through Shapiro’s comments and edits, and Pat said ”I would personally like to go through, when you set an agenda and say you will be done at 4pm, how many meetings are done at that time/ We always get put on the end, and I think we need to go through. If we have to do it then let’s go through first the ones we already have, then let’s see what Gene has to say.” At that point more WG members stated that they would have to leave the meeting due to other commitments and that they “prefer to delay until we can have the full group discussion.” Walker then said, “I too have a lot of comments…they must not have gotten recorded, but they would form the basis for a minority report.” Pat retorted, “ if it helps, we will make changes to what we have but I will be honest, we have made enough changes now, I don’t know we will make more changes to anything we have before. We have whittled it down and removed and recited and reworded with things in all places and chapters. Now you want to push us off to the next meeting so you can spend another two hours on our chapter. I don’t get it.” Shapiro made a motion to adjourn. With many WG members already having left the meeting and given their proxy vote to other WG members, the motion to adjourn passed, 8 yes, 2 no, 2 abstain.
Ben Beard provided a more detailed description of the recently published A National Public Health Framework for the Prevention and Control of Vector-Borne Diseases in Humans that he announced at the September meeting. Of note was the statement that “there is an increasing risk of all human vector-borne diseases… and the US is not prepared to deal with these diseases.” Key partners and stakeholders will be working together on this strategy, including public and patients. View the National Framework which Beard announced at the September meeting of the WG here: https://www.cdc.gov/ncezid/dvbd/framework.html
Verbal public comments were delivered by seven people including critical care nurse and mother of a child with Lyme, Janice Sutton. Janice described the horrifying experience that she and her daughter have gone through in attempting to get both an accurate diagnosis and appropriate treatment stating, “Doctors are only as good as their toolboxes, so let’s give them the tools they need to better help people.” Dorothy Leland, VP of Lymedisease.org and mother of a child with Lyme disease, urged HHS to “choose patient representatives who actually want to represent patients.“ Leland stated that Pat Smith, as the sole patient representative on the current WG panel, “has done an excellent job, but it is unfair to our constituency and individuals to expect any one person to carry such a burden.” She urged that the process must be transparent and patient representatives “should be nominated by or endorsed by patient advocacy groups.” She requested HHS select three “true advocates who are not afraid to go on the record for those that they represent” for the next WG panel. Phyllis Mervine, President of Lymedisease.org spoke to the issue of the CDC incidence maps and how they are hurting patients in California. Mervine explained, “the CDC Map downplays the incidence of Lyme disease in all but a handful of states” which is making it “more difficult for people with Lyme to be diagnosed in states not designated high risk by the CDC restrictive accounting system.” Mervine asked the WG for “a simple, quick and cost free fix,” which is “to ask the CDC to revert back to the previous style (of mapping).” She concluded that “the simple change would impact the health of all Americans irrespective of geographic regions.” Patient advocate, Carl Tuttle had received no response to an email that he sent to the WG regarding evidence of persistent Lyme infections after antibiotic treatment. So he asked Dr. Ben Beard “what is the motivation for suppressing evidence of persistent Lyme disease after extensive antibiotic treatment and claiming there is no evidence?” He ended with a quote from Dr. Kenneth Liegner, ‘ In time the mainstream handling of chronic Lyme disease will be viewed as one of the most shameful episodes in the history of medicine because elements of academic medicine, government and virtually the entire insurance industry have colluded to deny a disease.”
Public Comments Subcommittee
Co-chair Leigh Ann Soltysiak presented tables from the Public Comments Subcommittee, which summarizes incoming written public comments: priority areas/key themes through September 2020. New comments as well as recurrent themes received in August/September 2020 included:
“Alpha gal sufferer requests 100% transparency of all food and drug ingredients and training of medical personnel”
“EVOLVA (Company) EPA testing NOOTKATONE for insecticide and repellent development”
“Request that Multiple chemical Sensitivities (MCS) be included in the TBDWG report to Congress”
“Concern that CDC guidelines for Lyme management create challenges and obstacles for patient care, reimbursement and treatment”
“Lyme disease treatments should be covered by medical insurance”
Need for better testing, treatment and increased research funding for Lyme disease”
“Concern that TBDWG members allegedly referred to persistent Lyme infection as a ‘religious belief’”
The 17th meeting of the WG will take place on November 17th, 2020 from 9:00 am- 5:3o pm, ET. This online meeting is open to the public. Written comments and requests to make verbal comments must be received by midnight ET, Friday, November 6, 2020. For more information and registration visit HHS TBDWG here. Comments may be sent directly to the WG through email at email@example.com.
Working Group Meeting: Lyme Patient Access to Care Still Under Attack
The recent 2-day virtual meeting of the Federal Tick-Borne Disease Working Group (WG) on Day 1 was more subdued than prior meetings , but Day 2 again brought forth an effort to minimize the patient access to care chapter and chronic Lyme.
Day 1 September 15, 2020
Patients and patient advocates delivered verbal comments, including advocate Carl Tuttle, who asked Pat Smith “to hold Shapiro’s feet to the fire” in regard to persistent Lyme and patient advocate Lucy Barnes, who stated “patients are fighting for their lives” and “you know better.” Erin Walker, wife of PGA tour winner Jimmy Walker, a Lyme patient, emphatically expressed the need for better testing and better treatment as Lyme is a “real disease that affects real Americans.” Problems with patient access to care was a common theme in the verbal comments.
WG member Angel Davey presented a report from the Public Comments Subcommittee, which summarizes incoming public comments: priority areas/key themes. Of note were the number of comments received in June and July 2020 after the June 8th meeting of the WG. Recurrent themes of these comments included
“Denying the existence of persistent or chronic Lyme disease…”
“Access to care is poor…”
“Serologic diagnostic testing and CDC guidelines are inaccurate and hurting many people”
“Patients with chronic Lyme & other TBDs are being failed by the healthcare system”
“Patients with chronic Lyme must be heard”
“Deniers of chronic Lyme disease need to be removed from the TBDWG”
Chapter 8: Epidemiology and Surveillance Review.
In the discussion of this chapter, Pat Smith again reiterates that recommendations posted on the CDC guidelines webpage only addresses acute Lyme, and that this is the only guidance available to physicians and patients seeking resources. This chapter contains the minority report addressing “Effect of Geographic Restrictions on Lyme Diagnosis,” which specifies why the “diagnosis by geography” proviso should not have been removed from the WG report as a recommendation to Congress. The original recommendation which was in the patient access chapter was “CDC provide input to the Council of State & Territorial Epidemiologists, CSTE, that the Lyme disease surveillance case definition be revised such that it abandons the use of geographic parameters for the diagnosis of Lyme disease and inform clinicians and the public that Lyme disease has been reported in all states.”
On the topic of non-tick-bite transmission, Pat vehemently disagreed with Sam Donta that modes such as “other insect vectors” be dropped from discussion stating that more research is needed on possible insect-borne transmission, since research has shown mosquitoes can carry the Lyme bacteria, and that ”the whole process has been subverted to begin with.”
Chapter 9: Looking Forward Review: where Eugene Shapiro continued to contest the use of “persistent Lyme disease”. Repeated comments in the side bars viewable to the public included “persistent Lyme disease is undefined and is not a scientifically defined or recognized entity.”
Day 1 concluded with reviews of Chapters 1: “Background,” Chapter 2: “Methods,” and the Table of Contents and Title Page. Further review of the suggestions will be considered at another meeting.
After a lengthy discussion, a decision was made to include a separate chapter in the report to congress on Public Comments.
Day 2-September 22, 2020
Day 2 of meeting 15 resumed Sept. 22, beginning with reviews of Chapter 3: “Tick Biology, Ecology, and Control,” presented by CDC’s Dr. Ben Beard. Of note was that two times as many TBDs have been discovered in the past 60 years than the previous 60 years.
Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostic Review: was presented by Dr. Sam Donta. Immediately, there was a replay of the June 8 meeting with further disagreement regarding the word “likely” versus “possibly.” Dr. David Walker stated “likely as too strong a word” regarding the hypothesis that the effects of persisting organisms are the source of ongoing symptoms in patients with unresolved Lyme disease. After much discussion and disagreement regarding persistence, the WG agreed that a statement such as “Evidence continues to be gathered that supports that persistent infection plays a role” may be an acceptable solution, and wording will be revisited by the co-leads of this chapter.
Convergent views and difference of opinion continued into Chapter 5 review: “Causes, Pathogenesis, and Pathophysiological,” where disagreements arose about TBD ability to suppress, subvert or modulate immune system in humans and effects to response to treatment and increase risk of developing other infections. Dr. Walker stated that “this speculation requires a reference. I do not know of any supportive evidence.” Although Angel Davey cited references on human effects, arguments over the validity of animal studies to translate to human effects continued. It was agreed that further studies are needed.
Chapter 6: Treatment Options and Strategies Review: was presented by Dr. Sam Donta and Dennis Dixon, NIH. When discussing Rickettsial diseases, Pat Smith requested that the stated fatality rate of 20% be cited and/or updated with current numbers. Dr. Walker argued that this statement was in regard to untreated infections, however Pat argued that these numbers are being quoted from 1940’s and 1950’s studies, and that current citations are needed. Ben agreed to update with more timely and relevant data, especially bringing forth regional outbreaks in Arizona, which have higher numbers. Pat then said great, we can then include numbers from Lyme in high case areas.
Chapter 7: Clinician and Public Education, Patient Access to Care Review: was presented by Pat Smith and captain Scott Cooper, PA, the latter went down the previously addressed (online) comments one by one explaining the changes he and Ms. Smith had made. Drs. David Walker and Eugene Shapiro surfaced on the topic of “persistent Lyme.” This chapter review was again the longest and most contentious of all chapters discussed. Walker started off by disputing the patient percentage numbers that describe chronic and often debilitating symptoms. He believes the cited 35% to be too high and inconsistent with numbers used previously in the report. Walkers comments on the sidebar of the report continue to argue that ”persistent/chronic Lyme disease is an unproven hypothesis, and accused Pat Smith of using this chapter to address ”the author’s pet topics.” She explained that these numbers were generated from a study conducted by Dr. John Aucott, Johns Hopkins University. Shapiro went on to discredit the Aucott study arguing the validity of the patient cohort, to which Smith responded that the patient cohort was comprised of all EM rash patients. Ultimately, it was agreed that Captain Cooper and Ms. Smith would revise and include a range of percentages from various Lyme patient studies with chronic or persistent symptoms.
However, Shapiro continued his attack of the topic of “persistent Lyme disease” while attempting to discredit the use of the largest patient registry, MyLymeData with comments written on the sidebar of the report stating ”This is mostly propaganda and typically based on self-reports with no confirmation that the patients have Lyme disease.” In regard to the data presented where “67% (of patients) report that they have postponed or avoided medical treatment due to discrimination, disrespect or difficulty obtaining care, and nearly half (47%) report that they have been denied treatment.” Shapiro argued the credibility of the patient registry responding to Pat Smith, “I don’t buy it.” She explained that NIH uses patient registries, 72 of them. Pat went on to describe that this patient registry is a rigorous one, featured in college textbooks, in collaboration with UCLA, and a registry that has resulted in citations in 4 peer reviewed studies as well as having received $800,000 in funding from the National Science Foundation. Walker argued that “the evidence isn’t there that it really is associated with Lyme disease.” Dennis Dixon suggested a writing a preamble to this section describing what patient registries are and how they are collected. Pat responded, “we can certainly do that, but I believe that again, we are being discriminated against…our patients…and all of the information we have about them.” She further explained “every time we present something that other people use with many, many other diseases, it’s like we have to jump through hoops in order to indicate these people are sick.”
In response to erroneously reported case numbers that were discovered in the past subcommittee report on ehrlichiosis/anaplasmosis, Smith and Cooper replaced report text with quoted material from the CDC website. Walker did not like those CDC numbers. Discussion ensued regarding reported case numbers for each of the tick-borne diseases. Ben Beard suggested to just capture the big picture rather than talking about numbers in one year or another and stated ”diseases are on the rise and no one disputes that,” so why not just state ”cases over the past 15 years have increased significantly.” The co-leads will review that for inclusion.
The disagreements continued…In regard to Walker’s and Shapiro’s comments about NIH Lyme clinical treatment trials Cooper stated ” these are long standing professional disagreements.” Shapiro said “it could be presented in a much more balanced way”. Smith responded that they had already revised and made the changes as recommended. Shapiro stated “I’ll just write something…. a minority report I guess.” Smith said, “as long as you vote against this you certainly can do that. We indicated that there was a difference of opinion…and we did that. We felt that we addressed the huge discussion that was held last meeting…we looked back and read the summaries of the meeting…and we felt that we addressed those.” Shapiro said “I vote no.” To which Pat responded, “you can’t vote no, there is no motion on the floor.” When asked by Dennis Dixon if there were any minor wording suggestions to take the need for minority report off the table, Shapiro stated “No, I don’t…I think it is too great a gap.”
When contrasting the differing treatment guidelines (IDSA vs ILADS), Shapiro commented, “again the authors ignore the fact that ILADS recommendations are gross outliers,” and that the authors have presented an “inaccurate, biased table” and he wants it deleted. After much discussion about the table’s contents and title, co-leads agree to revisit. Shapiro stated that he did not believe that information is being presented in a balanced way and that he will move forward with a minority report. Pat reminded Shapiro that to write the minority report, he will have to vote against the report.
On the topic of “shared decision making,” Walker proposed removal of the entire section. He stated that he “can’t see how this is relevant to this chapter.” He stated in the comments that “The authors of this chapter have departed from its intention…and that they have presented too much content on the ideas espoused by ILADS…” Walker further commented “This is an inappropriate balance. It represents a biased overemphasis on Lyme disease in the context of this chapter.” Pat Smith again championed the voice of the patients explaining why this content is not only appropriate but supports the intent of the WG.
Jim Berger announced that HHS will be seeking nominations in the next couple of weeks for TBDWG members for work on next report to Congress due in 2022. 4 of 7 public members terms expire Dec.2020 , other 3 in June 2021. Nominees will be asked to submit CV or Resume through a link in the Federal Register which will be open for 30 days.
Lyme Patients: Speak Up Now on Persistent/Chronic Lyme! Sept 4 Deadline
Background: The upcoming meeting of the HHS Working Group on Sept. 15 may be your last chance to influence language on persistent/chronic Lyme. At the last meeting, several members of the Working Group (WG) worked hard to have language related to patients with persistent Lyme symptoms removed from the WG report which will go to Congress at end of year. Read more about the last TBDWG meeting.
At the upcoming September meeting, the WG will vote on proposed changes in language that can affect patient access to care. Please submit verbal or written comments now, deadline to request verbal comment or to submit written comment 11:59 p.m., ET,Friday, September 4, 2020.
Meeting Details: The fifteenth meeting of the Tick-Borne Disease Working Group (TBDWG) will be held on two non-consecutive days, September 15 and 22. This is an online meeting and everyone is welcome to attend. The TBDWG will review the draft 2020 report to the HHS Secretary and Congress, as well as review and approve graphics and images for the report.
How to Submit Your Request for Verbal Public Comment at September 15 meeting (heard online at meeting): Verbal remarks will be provided by the public over the phone during the live webcast and will become part of the archived recording and meeting summary that is posted afterward on the HHS website.
Deadline: All sign-up requests must be received by 11:59 p.m., ET,Friday, September 4
Use the email subject line: Verbal Public Comment – September 15
Next steps: If more requests to provide verbal public comment are received than can be accommodated during the meeting, speakers will be randomly selected. You will receive notification on the status of your request on Wednesday, September 9.
If you are selected to provide verbal public comment at the meeting, you will be asked to confirm that you are still available to speak during the assigned time. Upon confirmation, you will receive a call-in number and time to provide your comment. Each person will be limited to 3 minutes in order to accommodate as many speakers as possible. If you are no longer able to provide verbal public comment, HHS will randomly select another speaker.
If you are not selected, you are welcome to submit your name for consideration in a future meeting of the Working Group once the meeting information is posted.
Please note: All public comment requests that were made for the postponed August meeting will be reviewed for possible speaking opportunity at the September 15 meeting. Those who did not request to speak at the August meeting may also apply to speak for the September 15 meeting.
Please note: All public comment requests that were made for the postponed August meeting will be reviewed for possible speaking opportunity at the September 15 meeting. Those who did not request to speak at the August meeting may also apply to speak for the September 15 meeting.
How to Submit Your Written Public Comment: Written public comments are shared with Working Group members and are also posted on the HHS webpage. Written public comments will be made accessible to the public in advance of the meeting.
Use the email subject line: Written Public Comment – September 15
Provide your preferred identification: Explain how you prefer to be identified with your comment. Without this information, your comment will not be posted. You may choose one or more of the following options:
Use your name
Be listed as anonymous
Include your city and/or state
Provide comments on behalf of an organization (please include the organization’s full name)
Deadline: All written comments must be received by 11:59 p.m., ET, Friday, September 4
Writing your public comment:
Format: Comments must be in the body of your email or in an attached Word document.
Page Limit: Comments must not exceed four (4) pages in Calibri or Times New Roman, 11 point font (text that exceeds four pages will be deleted).
Graphics: Do not include graphics, images, text boxes, or tables. If included, they will not be retained.
Links: Hyperlinks will only be added for “.gov” sites (local, state, or federal). For all other reference sites, please insert the full URL (e.g., http://learn.genetics.utah.edu/content/epigenetics).
Attachments: Do not include any attachments. It is not possible to include attachments as supporting documentation to written comments.
Next steps: Your written comment will be posted to the HHS website before the meeting. If you have any questions or concerns about submitting your comment, contact firstname.lastname@example.org.
Series of Amendments Go Through Process to Increase Lyme/TBD CDC $$$
In a complex government process, the Tick Act–a bill that provides funding for Vector-Borne Diseases including Lyme– was not fully funded according to the Committee report on HHS. The Committee report has 16M for Lyme and 38M for vector-borne diseases.
(NOTE: as LDA has mentioned in prior information on the Tick Act, it is for Vector-Borne Diseases of which TBD are only a part).
To address the issue, Congressman Chris Smith (NJ-4) developed an amendment to raise that funding for TBD, which was co-sponsored by Congressman Collin Peterson (MN). During amendment development, the President’s budget request for 2021 was examined, which asked for $14 million increase over 2020 for vector-borne diseases. Suggested funding levels in the Tick Act for vector-borne diseases were also examined. The LDA provided input into that amendment process and concurred with an additional $11.4M to be asked for on top of the $2M increase in appropriations asked for in the report. Congressmen Smith and Peterson submitted the amendment for $11.4M, but Congressman Delgado (NY) also submitted an amendment, asking for $4M. The Congressmen agreed on $4M in an amendment Smith et al # 289.
Amendment # 289. Smith, Christopher (NJ), Peterson (MN), Stefanik (NY), Delgado (NY), Rose, Max (NY) does the following: Redirects $4 million from General Departmental Management at the Department of Health and Human Services to Emerging Zoonotic and Infectious Diseases at the Centers for Disease Control, for Lyme Disease and other Vector-Borne Diseases.
Listen to the video below of Congressman Smith pitching the amendment to the committee.
Contentious 9 Hour WG Meeting: Persistent Infection a Religious Belief? WG Co-Chair Says Yes
Pat Smith Describes Pre-Meeting Effort to Minimize Lyme.
Below in For the Record are the written comments LDA President Pat Smith, a public member of HHS TBD Working Group read (slightly compressed) into the record at the Working Group (WG) meeting on July 8 about the potential WG Chapter report for which she was responsible, the only one addressing patient issues. 89 written comments/deletions to the report had been suggested before the meeting by Working Group members. Working Group Co-Chair Dr. David Walker and Member Eugene Shapiro were responsible for moving to delete entire sections of Lyme material from the report, many of which called for the removal of much of the Lyme material and the de-emphasis of Patient Access to Care in the Chapter.
Co-Chair Says “almost religious belief that it’s a persistent infection”
At the meeting itself, Working Group Co-Chair, Dr. David Walker, and Member Eugene Shapiro made and seconded many motions to remove material from the proposed draft report including the two sets of guidelines, shared decision making, access to care, Lyme treatment trials, and cost of Lyme disease. There was also a discussion in which Shapiro and Walker wanted to remove Lyme mouse model studies and other animal studies that showed persistence that were included in the draft report, saying animal models were really not a good use for this infection.
Dr. Walker said there is “emphasis on belief…almost religious belief that it’s a persistent infection” and at various times said they probably didn’t have Lyme to start with. After many hours of this discussion, no other WG members would second the motions for removal. For the record: The importance of today’s meeting and our Chapter review can’t be overstated. My Access to Care, Education & Training subcommittee including healthcare providers and patients, with expertise in the problems associated with patients’ access to care including physician education, submitted a 75-page subcommittee report and additional 45 citation pages documenting these problems to get help for a body of patients neglected especially those who develop the most serious stage of Lyme and to prevent acute patients from reaching that stage. Patients looked to this WG created through legislation initiated by, written by, and pushed through Congress by Lyme patients/advocates. In 2019 through now, 78% of comments to the online WG mailbox were about TBD/Ticks, 70% of those TBD comments were on Lyme disease and 81% of those were on chronic/persistent/PTL, not acute.
Before the January 2020 Working Group meeting, WG members were instructed to read each subcommittee report. Subcommittee co-chairs presented reports at that meeting. In my subcommittee case, since I had not had an active co-chair for a while, a subcommittee member stand-in, not permitted to vote or ask questions, was allowed to present with me a PowerPoint, including Subcommittee rationale and recommendations later discussed, modified, and voted upon.
Then, writing groups of 2 WG members each were solicited for each Chapter to be written for the WG report to Congress. The WG was definitively told that all information for the WG report had to be taken from the Subcommittee reports. I asked if newly published information, for example, could be used, was told, yes, but then the WG would have to approve that new material. Recently activated WG alternate member Captain Scott Cooper and I volunteered to write the Chapter we’re presenting today.
As directed, we pulled language from the subcommittee reports, submitted our Chapter for review and was told “well organized, appropriate to audience level, and it flowed logically,” but we needed to “rebalance” the chapter as there was too much information on Lyme disease and access to care than other tick-borne diseases and education. Suggested rebalancing included removing a factual table from CDC which listed TBDs for 3 years, in descending order of reported case numbers, as the table could “inadvertently diminish the importance of other tick-borne diseases because their numbers are much lower.” It was OK that we led with burden of disease (cost, quality of life, & productivity), compelling reasons for Congress to act. However, we should remove those items from our Chapter report background and put them into the background for the entire WG report, despite the fact they were developed specifically for our patient issues. Bottom line: minimize Lyme, reduce access to care.
We incorporated additional other TBD material from subcommittee reports into the Chapter and shortened the Lyme portion. We didn’t remove the table, since it factually portrayed reported case numbers, nor did we remove our background material germane for our specific patient issues. After another review submission, we were told the Chapter was “starting to become balanced” but now it was too long. We needed to shorten it. We again shortened to include removing the redundant list of recommendations upfront, already elsewhere in the Chapter.
All WG Chapter Writers had a deadline to post draft Chapters to a WG private Share Point site. WG members had a May 22 deadline to submit comments there on all chapters. All Chapter language was now up for grabs, we were told, even the language we took from the already discussed Subcommittee reports, not just new language. I objected, since that seemed to contradict process discussion at the prior meeting. Significantly, I objected to the lack of process transparency, which was directing these online SharePoint discussions to be behind the scenes–not WG members in public holding transparent discussion with all WG members, embodying the intent of a FACA Working Group. Time went by with no response to my objection, so I reluctantly decided to proceed with filing for resolution through a FACA complaint, but I was subsequently informed my concerns were heard, and all discussion would now be in public, as we are doing today so I did not proceed with the complaint.
While working in the private SharePoint site, I stumbled across an unknown person who had direct access to all Chapters and material in the site. Research showed me this individual was from NIH, not either the NIH Working Group member or alternate—another NIH employee, an attorney. Upon questioning the individual’s identity and purpose, I was informed NIH requested that that individual be allowed access to our SharePoint documents and was given access. It appears that government employee WG members have rights public members do not have, are not aware of, and do not have to be informed of. Since public members are considered special government employees, I requested to federal officials that I be permitted to have a patient advocate attorney in SharePoint to review for patient perspective. I was informed my request was denied by WG legal counsel.
These items coupled with others such as a WG member who did not attend being allowed to vote by proxy through the co-chair, without knowledge of the WG, and the unexplained delay in releasing these draft Chapters to the public prior to this meeting for their review and comments before the WG vote are concerning, and refusal to provide the public with government inventories as agreed to at the April meeting. I questioned those practices, which in my opinion, exhibit a disregard for the public, in particular, the patient community. History coupled with these practices reinforce the sentiments of many in the public that they are again being deceived by their own government.
As we move forward on our Chapter section now, note that our printed report has 12 pages with internal citations to address the decades-long problems of hundreds of thousands of Lyme patients plus other tick-borne diseases patients. Additionally, there are 7+ printed pages of comments from SharePoint made by WG members on our Chapter, a number of which call for removal of much of our documented material on Lyme disease─ a disease under-reported by a factor of 10 according to CDC studies and CDC testimony by Lyle Peterson to a Senate Committee, (1) meaning about 350,000 cases annually. According to NIH, Lyme is a disease that makes up 82% of tick-borne diseases, (2) and there were 74 Lyme deaths in 2017. (3) Thus, our Chapter focuses on the tick-borne disease whose patients comprise the largest burden of disease, Lyme disease. That is balance. Captain Cooper, I now turn further Chapter discussion to you.
(3) NIH says 74 deaths in 2017.NOTE: I had accessed this info prior and printed out the information. Link no longer goes to the page. NIH asked at the meeting where I got that death data as they could not find it anywhere. I have sent it to them.