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.
Chapter 11: 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: Conclusion were 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.
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:
It is my strong opinion that the Lyme/MSIDS community will only move forward by doing the work ourselves independently from the government and institutions/researchers that own patents on products relating to tick-borne illness. We have tried this approach for over 40 years with no measurable positive results. Productive help has only occurred by independent researchers and ILADS trained doctors who are clinically treating patients.
I do not support or promote any more Lyme/MSIDS/tick research funding to the NIH/CDC/NIAID/IDSA who have only repeatedly proven they are against patients.
- https://madisonarealymesupportgroup.com/2020/02/10/the-bitter-feud-over-lymerix/ Excerpt:
Five months later, in October, the same two-step serological standard was adopted for surveillance and research purposes in Dearborn, Michigan, at the Second National Conference on Lyme Disease Testing, sponsored by the Association of State and Territorial Public Health Laboratory Directors and the CDC. The most divisive part of the two-step diagnostic standard – now called the Dearborn criteria – was elimination from the Western blot of two Bb proteins, outer surface protein A (OspA), from which LYMErix was made, and outer surface protein B (OspB), the intended component of next-generation vaccines. For the vaccine trials, this made sense. In a universe of the vaccinated, testing for OspA antibodies would only serve to blur the line between inoculation and disease. But removal of OspA and OspB for other purposes was viewed with alarm by many practitioners, who knew these proteins were specific to Lyme disease and sometimes the only markers present in those with late-stage disease.
Many of the sickest patients no longer meet the standard.